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.
What you’re looking at
Open the specimen from the Worklist. Its Workflow tab shows one form only — the one for the stage it has reached — so you never have to work out which screen you should be on.
The screen form opens with a matrix banner, then Screen Date & Time * and Technician Name *. Immunoassay Screen Results lists one row per analyte on the panel: a value box, Cut: {cutoff}, and a badge that flips between Negative and Non-Negative as you type. For urine only, a Specimen Validity Testing (SVT) card follows with its own verdict badge — Valid, Dilute, Substituted, Adulterated or Invalid. One button finishes the stage: Finalize Screen Results.
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.
The matrix decides the cutoffs
Urine and oral fluid are governed by different guidelines and different numbers, and the banner tells you which set is being applied 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} and badges the value against it as you type. All values in ng/mL, screen then confirmation.
The gap is large — THC screens at 50 and confirms at 15 in urine, but at 4 and 2 in oral fluid. Entering a reading against the wrong matrix is the mistake to watch for, which is what the banner is for. In urine, 6-acetylmorphine is only evaluated when morphine screens at or above 2000 ng/mL, because 6-AM degrades to morphine; in oral fluid it is always evaluated.
Run the initial screen
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.
Enter each analyte
Enter the instrument’s reading, not your reading of it, and watch the badge: Non-Negative at or above the cutoff, Negative below it.
Complete specimen validity testing — urine only
The Specimen Validity Testing (SVT) card takes Creatinine (mg/dL), Specific Gravity, pH, Nitrites (µg/mL), Chromium (VI) Detected and Oxidants Detected — the latter revealing Oxidant Type (“e.g., Bleach, Peroxide”). Oral fluid has no SVT card, correctly: saliva volume and chemistry are not meaningful adulteration markers.
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.
Finalize the screen
Select Finalize Screen Results. That single action records the readings and finalizes the stage — Initial screen results finalized — and writes an Initial Immunoassay Screen event to the chain of custody. Those are two different permissions, so if you hold only Enter results at the bench the readings save and you are told Screen data saved, but could not advance order.
Confirm the non-negatives
The confirmation form shows only the analytes that came back non-negative — you do not confirm a whole panel to prove a single finding. If nothing did, 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.
Enter the confirmation values
Record Confirmation Date & Time * and Technician / Lab Director *, then enter each non-negative analyte’s confirmed quantitation under GC-MS / LC-MS/MS Confirmation Results, against its confirmation cutoff for the matrix.
Read the methamphetamine rule if it fires
ClinikEHR applies 49 CFR § 40.97(b)(3) for you: 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. The amphetamine linkage threshold is 100 ng/mL in urine and 25 ng/mL in oral fluid. Do not re-enter the amphetamine value to make it go away.
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.
Certify as lab director
Tick Lab Director Certification: “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.
Save, then report
Save Results keeps the work on the bench — Confirmation results saved. Report to MRO hands it on — Results reported to MRO — and that is the sign-out act. See MRO review and the employer report.
Finalizing without confirmation
A specimen that screened non-negative and was never confirmed cannot be signed out as Positive. Finalizing one raises the SAMHSA Compliance Check dialog, subtitled “49 CFR § 40.97 / HHS Mandatory Guidelines”, listing the unconfirmed analytes by code and name.
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.
Who can do this
Role decides whether the bench screens open. Permission decides which half of the bench you may do — the split between entering a reading and signing it out is the supervision model, not an obstacle.
A Lab Manager does not hold Verify and authorise results by default — that comes from the access tier, not the administrative role, because authorising a result is a scientist’s act. Someone on Own bench may enter readings and nothing else. A QC Officer is review-only by design, and a phlebotomist never reaches the bench.
- Enforcement is opt-in, per person. Someone never saved in the permissions sheet is unrestricted, and the sheet warns “Saving starts enforcing”.
- A denied action is recorded; an allowed one is not. Where a figure is not yours to see it renders hidden or as a dash, never as a zero.
At a collection centre the whole bench is disabled regardless of permission: “This site is a collection center — register specimens and dispatch them to your laboratory. Accessioning, screening and reporting are done at the full lab and are disabled here.”
See Permissions.
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.
- Every analyte shows its badge against the cutoff for the correct matrix.
- After Report to MRO, the order sits at Reported to MRO.
Common issues
The cutoffs on screen are not the ones I expected
Check the matrix banner. If it names the wrong matrix, the specimen type on the order is wrong — fix that rather than entering values against the wrong cutoffs.
Screen data saved, but could not advance order
The readings were recorded; the finalisation was refused. Finalize Screen Results does both in one submit, and finalizing needs Verify and authorise results. Ask your verifying scientist to finalize.
An analyte I screened is missing from the confirmation form
The confirmation form lists only the non-negatives. An analyte that screened negative needs no confirmation.
Methamphetamine was downgraded to negative
That is 49 CFR § 40.97(b)(3) working. Methamphetamine cannot be reported as confirmed positive without amphetamine co-present at the matrix threshold — 100 ng/mL in urine, 25 ng/mL in oral fluid. The alert names both values so you can check the run; the rule is not negotiable.
Lab director must certify results before saving
The Lab Director Certification box is an attestation by a qualified lab director, so it must be ticked by one — not by the technician on their behalf.
There is no SVT card on the screen form
You are working an oral-fluid specimen. Specimen validity testing is required for urine only, and its absence here is correct.
Everything on the bench is disabled
This order has no laboratory record, so nothing was saved
The specimen’s laboratory record is missing, so there is nowhere to store the readings you just entered. Nothing was saved and nothing was finalized — re-run the lab accession step for this specimen, then enter the values again.If it happens a second time on the same order, stop and raise it with your lab director before recording anything further against that specimen. An order that reaches the bench without a laboratory record has skipped a custody step, and that is a question about the specimen, not about the form.
This urine specimen has no specimen-validity result recorded
A urine screen is only complete with its SVT readings, so the stage cannot be finalized without them. Re-record the initial screen, completing the Specimen Validity Testing (SVT) card. Oral fluid never asks for this — see above.
FAQ
Can I report a screen positive without confirmation?
No. Per 49 CFR § 40.97 an analyte cannot be designated Positive without GC-MS or LC-MS/MS confirmation. The only thing on offer is Finalize as Non-Negative, which reports those analytes as Non-Negative (presumptive screen result) with a footnote citing § 40.97.
Why is a drug-negative specimen still reportable?
Because validity is a separate finding. A urine specimen can be below every drug cutoff and still be Adulterated, Substituted or Invalid on SVT — the alert says exactly that.
Can I change a reading after finalizing the screen?
Not from the screen form. A change after sign-out is an amendment and needs Amend a verified result, which by default only the All sites tier holds.
Who counts as the lab director for the certification?
The Lab Director, or another scientist qualified to verify. A technician may run the sample and enter the reading; only the verifying scientist authorises it.
Does a custom analyte use the same cutoffs?
It uses whatever you defined for that matrix, and it only appears in a panel once it has a confirmation cutoff for that specimen type — see MRO review and the employer report.