> ## Documentation Index
> Fetch the complete documentation index at: https://help.clinikehr.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Screen and confirm a specimen

> Run the immunoassay screen with the right cutoffs for your matrix, add specimen validity testing, and confirm non-negatives by GC-MS or LC-MS/MS.

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      <a href="/platform/help/contact-support">contact support</a> and include
      your workspace name and the time the problem happened, so we can find the
      matching entry in your audit log.
    </p>
  </div>;

export const TaskHeader = ({before, time, after}) => <div className="ck-task">
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export const Availability = ({editions = ['all'], plans, roles, note}) => {
  const list = editions.includes('all') ? ['clinic', 'pharmacy', 'lims'] : editions;
  return <div className="ck-avail" role="note" aria-label="Feature availability">
      <span className="ck-avail__label">Available in</span>

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<Availability editions={['lims']} plans="All plans" roles="Entering screen and confirmation results needs “Enter results at the bench”. Reporting to MRO needs “Verify and authorise results”." />

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**.

<Path steps={['Sidebar', 'Worklist']} />

<TaskHeader before="An accessioned specimen with both seals recorded, and instrument readings to enter" time="5 minutes per specimen at each stage" after="A screened specimen, its non-negatives confirmed and certified, ready for MRO review" />

## The analytes and the panels

| Code | Analyte                   |
| ---- | ------------------------- |
| THC  | Marijuana (THC)           |
| COC  | Cocaine                   |
| COD  | Codeine                   |
| MOR  | Morphine                  |
| SAM  | 6-Acetylmorphine (Heroin) |
| HYD  | Hydrocodone               |
| HYM  | Hydromorphone             |
| OXY  | Oxycodone                 |
| OXM  | Oxymorphone               |
| PCP  | Phencyclidine (PCP)       |
| AMP  | Amphetamine               |
| MET  | Methamphetamine           |
| MDMA | MDMA (Ecstasy)            |
| MDA  | MDA                       |

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](/lims/dot/lab-intake-mode).

## 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.

### Urine — 49 CFR Part 40 and the HHS Mandatory Guidelines

All values in ng/mL.

| Analyte | Initial screen | GC-MS / LC-MS/MS confirmation |
| ------- | -------------- | ----------------------------- |
| THC     | 50             | 15                            |
| COC     | 150            | 100                           |
| COD     | 2000           | 2000                          |
| MOR     | 2000           | 2000                          |
| SAM     | 10             | 10                            |
| HYD     | 300            | 100                           |
| HYM     | 300            | 100                           |
| OXY     | 100            | 100                           |
| OXM     | 100            | 100                           |
| PCP     | 25             | 25                            |
| AMP     | 500            | 250                           |
| MET     | 500            | 250                           |
| MDMA    | 500            | 250                           |
| MDA     | 500            | 250                           |

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

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

All values in ng/mL.

| Analyte | Initial screen | GC-MS / LC-MS/MS confirmation |
| ------- | -------------- | ----------------------------- |
| THC     | 4              | 2                             |
| COC     | 15             | 8                             |
| COD     | 30             | 15                            |
| MOR     | 30             | 15                            |
| SAM     | 4              | 2                             |
| HYD     | 30             | 15                            |
| HYM     | 30             | 15                            |
| OXY     | 30             | 15                            |
| OXM     | 30             | 15                            |
| PCP     | 3              | 2                             |
| AMP     | 50             | 25                            |
| MET     | 50             | 25                            |
| MDMA    | 50             | 25                            |
| MDA     | 50             | 25                            |

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.

## Run the initial screen

<Steps>
  <Step title="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.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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.
  </Step>
</Steps>

## 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.**

<Steps>
  <Step title="Record when and who">
    **Confirmation Date & Time \*** and **Technician / Lab Director \***.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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.
  </Step>

  <Step title="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**.
  </Step>

  <Step title="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](/platform/team/permissions).
  </Step>
</Steps>

## 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".

<Warning>
  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.
</Warning>

## 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](/lims/dot/reports).

## If something goes wrong

<AccordionGroup>
  <Accordion title="The cutoffs on screen are not the ones I expected">
    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.
  </Accordion>

  <Accordion title="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, and that is the correct handling.
  </Accordion>

  <Accordion title="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. The alert names both values so you can check the run, but the rule is not negotiable.
  </Accordion>

  <Accordion title="I cannot save the confirmation">
    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.
  </Accordion>

  <Accordion title="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.
  </Accordion>

  <Accordion title="I cannot report to MRO, only save">
    You hold "Enter results at the bench" but not "Verify and authorise results". That separation is usually deliberate supervision — hand it to your verifier.
  </Accordion>

  <Accordion title="Everything on the bench is disabled">
    You are at a collection centre. Screening happens at the full lab — see [Collect a specimen and complete the CCF](/lims/dot/collection).
  </Accordion>
</AccordionGroup>

<StillStuck topic="screening or confirmation" />