Toxicology laboratory software that keeps the specimen, the confirmation and the CLIA record together
A toxicology laboratory is a CLIA certified lab that screens and confirms drugs in biological specimens, usually urine or blood, for clinical or workplace testing. Certification is mandatory before a lab may report a result, and 42 CFR 493.1445 requires the laboratory director to be onsite at least once every 6 months with at least 4 months between visits. Neurobird holds the chain, the run and the record together.
Neurobird Toxicology Laboratory in short
- Hold chain of custody from collection to disposal, with every transfer timestamped and attributed
- Link the screening result and the confirmation to the same specimen and the same custody chain
- Attach instrument QC and calibration state to the run that produced a result
- 42 CFR 493.1445 Sets out the laboratory director's responsibilities for a high complexity laboratory, including oversight of testing and personnel competency. eCFR, 42 CFR 493.1445
- 6 months The maximum interval permitted between onsite visits by the laboratory director, with at least 4 months between the two minimum visits. eCFR, 42 CFR 493.1445
- Pricing runs 550 to 2900 US dollars per month across 3 tiers. Early access is free.
What toxicology laboratories actually deal with
Why it stays broken
A toxicology lab is an instrument shop, a custody process and a regulated entity at the same time. The LIS knows results, the instruments know runs, and CLIA cares about oversight and competence. No single record holds a specimen, its confirmation and the director sign off that makes the result reportable.
A CLIA laboratory director must be onsite at least once every 6 months, with at least 4 months between the two minimum visits.
The laboratory must have a director who meets the qualification requirements of § 493.1443 of this subpart and provides overall management and direction in accordance with § 493.1445 of this subpart.
Neurobird Toxicology Laboratory Document Automation Platform
One record per specimen: collection, custody, screen, confirmation, QC state of the instrument that ran it, and the review that released the result. A survey question resolves to a record rather than a folder.
- 1Hold chain of custody from collection to disposal, with every transfer timestamped and attributed
- 2Link the screening result and the confirmation to the same specimen and the same custody chain
- 3Attach instrument QC and calibration state to the run that produced a result
- 4Record director review and competency assessments where a surveyor expects to find them
What changes with Neurobird Toxicology Laboratory?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird Toxicology Laboratory |
|---|---|
| Chain of custody lives on a paper form that is scanned after the result has already been reported | Hold chain of custody from collection to disposal, with every transfer timestamped and attributed |
| Screening and confirmation sit in two instrument systems and are joined by a spreadsheet | Link the screening result and the confirmation to the same specimen and the same custody chain |
| Director review is signed on paper, so proving oversight during a survey means finding the paper | Attach instrument QC and calibration state to the run that produced a result |
Who is this for?
The same specimen, three different obligations.
You support treatment decisions
Turnaround matters and so does defensibility. You need the confirmation tied to the screen without a spreadsheet in between.
You report to employers
Chain of custody is the product. A gap in the chain is a result that cannot be used, however good the chemistry was.
You run several benches
Director oversight and competency records have to be provable per site, which is exactly what the visit rule asks about.
How does Neurobird Toxicology Laboratory work?
Accession with custody
The specimen is booked in against its custody form, so the chain exists in the system before any instrument sees the sample.
Screen, then confirm
A presumptive positive carries forward to confirmation on the same record, and the confirmation cannot be orphaned from the screen that triggered it.
Release on review
Results are released against a recorded review, so oversight is evidence rather than a recollection.
What CLIA requires of a high complexity laboratory
The certification and oversight duties a toxicology laboratory is surveyed against.
Sets out the laboratory director's responsibilities for a high complexity laboratory, including oversight of testing and personnel competency.
eCFR, 42 CFR 493.1445The maximum interval permitted between onsite visits by the laboratory director, with at least 4 months between the two minimum visits.
eCFR, 42 CFR 493.1445The year the Clinical Laboratory Improvement Amendments established federal standards for all testing on human specimens, which is what CLIA certification derives from.
CMS, CLIA overviewAll CLIA certification and survey fees must now be paid online through pay.gov, and paper cheques are no longer accepted.
CMS, CLIA overviewThe evaluation of proficiency testing performance and comparison of test results, which a toxicology bench is measured on twice yearly.
eCFR, 42 CFR 493.1236The specimen, as your bench would run it
Tick a specimen to confirm a presumptive positive and watch the custody chain and review state follow.
Watch the fields extract from the document.
Toxicology laboratory software questions, answered
Key terms
- What is a toxicology laboratory?
- It is a laboratory that detects and measures drugs and their metabolites in biological specimens, typically by an immunoassay screen followed by a mass spectrometry confirmation. Because it tests human specimens it must hold CLIA certification before it may report a result.
- What is chain of custody?
- It is the documented sequence of everyone who handled a specimen from collection to disposal, with each transfer recorded. In workplace testing the chain is as much the product as the chemistry, because a gap in it makes an otherwise valid result unusable.
Does this replace our LIS?
No. It reads from it and sits around it. The LIS holds results. This holds the specimen's custody, the link between screen and confirmation, the instrument state and the review that released the result.
How does it help at a CLIA survey?
It puts director review, competency assessment and instrument QC against the runs they apply to, so an oversight question resolves to a record rather than to a filing cabinet.
Why we are building this
T
o
x
i
c
o
l
o
g
y
i
s
o
n
e
o
f
t
h
e
f
e
w
p
l
a
c
e
s
w
h
e
r
e
t
h
e
p
a
p
e
r
w
o
r
k
i
s
g
e
n
u
i
n
e
l
y
p
a
r
t
o
f
t
h
e
r
e
s
u
l
t
.
A
p
e
r
f
e
c
t
c
o
n
f
i
r
m
a
t
i
o
n
w
i
t
h
a
b
r
o
k
e
n
c
h
a
i
n
i
s
w
o
r
t
h
l
e
s
s
,
a
n
d
m
o
s
t
l
a
b
s
s
t
i
l
l
c
a
r
r
y
t
h
a
t
c
h
a
i
n
o
n
p
a
p
e
r
.
W
e
t
h
i
n
k
t
h
e
c
u
s
t
o
d
y
,
t
h
e
r
u
n
a
n
d
t
h
e
o
v
e
r
s
i
g
h
t
b
e
l
o
n
g
o
n
o
n
e
r
e
c
o
r
d
.
T
h
e
C
L
I
A
p
r
o
v
i
s
i
o
n
s
w
e
w
o
r
k
e
d
f
r
o
m
a
r
e
l
i
n
k
e
d
a
b
o
v
e
s
o
y
o
u
c
a
n
c
h
e
c
k
o
u
r
r
e
a
d
i
n
g
o
f
t
h
e
m
.
Where the requirement comes from
Primary sources, straight from the regulators.
- eCFR, 42 CFR 493.1445, laboratory director responsibilities The oversight duties and the onsite visit intervals a director is held to.
- CMS, Clinical Laboratory Improvement Amendments Certification, survey and fee mechanics for every laboratory testing human specimens.
- eCFR, 42 CFR 493.1236, comparison of test results Proficiency testing evaluation and the twice yearly verification of test performance.
- eCFR, 42 CFR Part 493, laboratory requirements The full CLIA part, useful when a survey finding cites a section you have not read.
How much does Neurobird Toxicology Laboratory cost?
Priced per laboratory because the certificate, the director and the survey are laboratory level things. Accessions, runs and users are unlimited on every tier.
- One laboratory
- Unlimited accessions
- Chain of custody
- Instrument QC log
- Screen to confirmation linking
- Director review workflow
- Competency records
- Survey export
- Unlimited sites
- Per site oversight evidence
- Instrument integrations
- Priority support
Get free early access
Early access means we model your panels, cutoffs and instrument list before you accession anything, and you keep the account free while we do it.
Straight answer on where this is: The software is in development. Nothing is purchasable today. Early access means you shape it and pay nothing while we build.
Prefer email? Write to office@neurobird.com and a person will reply. No autoresponder.