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The bench does two separate things to a drug-testing specimen, and the whole regulatory framework hangs on the difference between them. The initial immunoassay screen says an analyte is present above a threshold — that is a presumptive finding and its name is Non-Negative. Only GC-MS or LC-MS/MS confirmation can call an analyte Positive.

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The analytes and the panels

The DOT 5-Panel is the mandatory federal panel: THC, COC, MOR, AMP and PCP. The DOT 14-Panel is all fourteen analytes above. Labs that also run non-DOT work can define their own panels — see Reference lab mode.

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The matrix decides the cutoffs

Urine and oral fluid are governed by different guidelines and different numbers, and the form tells you which set it is applying before you enter anything:
  • Specimen matrix: Oral Fluid — HHS OFMG cutoffs apply. SVT is not required for oral fluid.
  • Specimen matrix: Urine — HHS MG urine cutoffs apply. SVT is required.
You do not choose the cutoffs. Each field shows Cut: {cutoff} beside it, and ClinikEHR badges the value Negative or Non-Negative against that number as you type.

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Urine — 49 CFR Part 40 and the HHS Mandatory Guidelines

All values in ng/mL. In urine, 6-acetylmorphine is only evaluated when morphine screens at or above 2000 ng/mL, because 6-AM degrades to morphine in urine.

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Oral fluid — HHS Oral Fluid Mandatory Guidelines, effective 2020-01-01

All values in ng/mL. The gap between the two matrices is large — THC screens at 50 and confirms at 15 in urine, but at 4 and 2 in oral fluid. Entering an oral-fluid reading against a urine expectation, or the reverse, is the mistake to watch for; the form’s matrix banner is there so you never have to remember which set you are on. In oral fluid, 6-acetylmorphine is always evaluated — saliva is fresher and 6-AM is the primary heroin marker.

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Run the initial screen

1

Open the screen form

Find the specimen on the Worklist and open it. The Workflow tab shows Initial Screen for an accessioned specimen, with the matrix banner at the top.
2

Record when and who

Screen Date & Time * and Technician Name * are both required. The technician’s name is part of the custody record, not a convenience field.
3

Enter each analyte

The Immunoassay Screen Results card lists one row per analyte on the panel: a value box, Cut: {cutoff}, and a Negative or Non-Negative badge that updates as you enter. Enter the instrument’s reading, not your reading of it.
4

Complete specimen validity testing — urine only

For urine, the Specimen Validity Testing (SVT) card is required: Creatinine (mg/dL), Specific Gravity, pH, Nitrites (µg/mL), and an oxidant checkbox with Oxidant Type (“e.g., Bleach, Peroxide”). A verdict badge shows the outcome. Oral fluid has no SVT card, correctly — saliva volume and chemistry are not meaningful adulteration markers.
5

Read a failed validity result

A failing SVT raises a red alert: SVT result: ADULTERATED/SUBSTITUTED/ INVALID. This result will affect the final lab result status even if drug screens are negative. A specimen can be entirely negative for drugs and still be reportable as adulterated or substituted.
6

Finalize the screen

Select Finalize Screen Results. That single action records and finalizes the screen, and writes an Initial Immunoassay Screen event to the chain of custody.

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Confirm the non-negatives

The confirmation form only shows the analytes that came back non-negative on the screen — you do not confirm a whole panel to prove a single finding. If nothing screened non-negative you get No Non-Negative Analytes — All analytes were negative on the initial screen. No GC-MS confirmation is required. The result can be reported to MRO directly.
1

Record when and who

Confirmation Date & Time * and Technician / Lab Director *.
2

Enter the confirmation values

Under GC-MS / LC-MS/MS Confirmation Results, enter each non-negative analyte’s confirmed quantitation against its confirmation cutoff for the matrix.
3

Read the methamphetamine rule if it fires

ClinikEHR applies 49 CFR § 40.97(b)(3) for you and tells you when it has: Methamphetamine ≥ {cutoff} ng/mL but Amphetamine < {threshold} ng/mL. Per HHS mandatory guidelines, methamphetamine CANNOT be reported as confirmed positive — this result will be reported as Negative. Do not override it or re-enter the amphetamine value to make it go away.
4

Read the confirmed positive alert

Where analytes genuinely confirm above cutoff, a red Confirmed Positive alert lists them. That list is what reaches the MRO.
5

Certify as lab director

Tick the Lab Director Certification box: “I certify that these GC-MS/LC-MS/MS confirmation results are accurate, have been reviewed and approved by a qualified laboratory director, and comply with 49 CFR Part 40 and HHS Mandatory Guidelines.” Without it you get Lab director must certify results before saving or Lab director must certify before reporting to MRO.
6

Save, then report

Save Results keeps the work on the bench. Report to MRO hands it on — the toast reads Results reported to MRO — and that is the sign-out act, so it needs the “Verify and authorise results” grant. See Permissions.

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Finalizing without confirmation

If you try to finalize a specimen that was screened but never confirmed, ClinikEHR raises the SAMHSA Compliance Check dialog, subtitled “49 CFR § 40.97 / HHS Mandatory Guidelines”.
The dialog reads: “Per HHS Mandatory Guidelines, an analyte cannot be designated Positive without confirmation. If you finalize now, the report will list these analytes as Non-Negative (presumptive screen result) with a footnote citing § 40.97.” Your choices are Cancel and Finalize as Non-Negative — there is no third option that produces a Positive, and there must not be. An unconfirmed screen reported as Positive is an employment decision made on evidence that will not stand up.

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Check it worked

  • The specimen has moved off the screening stage of the Worklist and carries its result status.
  • The Chain of Custody tab shows an Initial Immunoassay Screen event, and a GC-MS / LC-MS-MS Confirmation event where confirmation was needed, each with the technician’s name and time.
  • Every analyte you entered shows its badge against the cutoff for the correct matrix.
  • After Report to MRO, the order appears on the MRO’s queue — see MRO review and the employer report.

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If something goes wrong

Check the matrix banner at the top of the form. Urine and oral fluid use different guidelines and very different numbers. If the banner names the wrong matrix, the specimen type on the order is wrong — fix that rather than entering values against the wrong cutoffs.
The confirmation form lists only the non-negatives. An analyte that screened negative needs no confirmation, and that is the correct handling.
That is 49 CFR § 40.97(b)(3) working. Methamphetamine cannot be reported as confirmed positive without amphetamine co-present at the matrix threshold. The alert names both values so you can check the run, but the rule is not negotiable.
The Lab Director Certification box is required — Lab director must certify results before saving. It is an attestation by a qualified lab director, so it must be ticked by one.
You are working an oral-fluid specimen. Specimen validity testing is required for urine only, and its absence here is correct.
You hold “Enter results at the bench” but not “Verify and authorise results”. That separation is usually deliberate supervision — hand it to your verifier.
You are at a collection centre. Screening happens at the full lab — see Collect a specimen and complete the CCF.