# 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.

- URL: https://neurobird.com/toxicology/
- Product: Neurobird Toxicology Laboratory Document Automation Platform
- Niche: toxicology laboratory
- Buyer: toxicology laboratories
- Status: in development, open for early access
- Updated: 2026-08-22

## What Neurobird Toxicology Laboratory does

- 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
- Record director review and competency assessments where a surveyor expects to find them

## How it works

1. **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.
2. **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.
3. **Release on review** Results are released against a recorded review, so oversight is evidence rather than a recollection.

## From the source material

> 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.

Source: law.cornell.edu, https://www.law.cornell.edu/cfr/text/42/493.1441

## Industry context

- **42 CFR 493.1445** Sets out the laboratory director's responsibilities for a high complexity laboratory, including oversight of testing and personnel competency. (source: eCFR, 42 CFR 493.1445, https://www.law.cornell.edu/cfr/text/42/493.1445)
- **6 months** The maximum interval permitted between onsite visits by the laboratory director, with at least 4 months between the two minimum visits. (source: eCFR, 42 CFR 493.1445, https://www.law.cornell.edu/cfr/text/42/493.1445)
- **1988** The year the Clinical Laboratory Improvement Amendments established federal standards for all testing on human specimens, which is what CLIA certification derives from. (source: CMS, CLIA overview, https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)
- **100%** All CLIA certification and survey fees must now be paid online through pay.gov, and paper cheques are no longer accepted. (source: CMS, CLIA overview, https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)
- **493.1236** The evaluation of proficiency testing performance and comparison of test results, which a toxicology bench is measured on twice yearly. (source: eCFR, 42 CFR 493.1236, https://www.law.cornell.edu/cfr/text/42/493.1236)

## Pricing

- Single bench: $550 per month
- Certified: $1,300 per month
- Network: $2,900 per month

## Questions

### 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.

## Sources

- [eCFR, 42 CFR 493.1445, laboratory director responsibilities](https://www.law.cornell.edu/cfr/text/42/493.1445)
- [CMS, Clinical Laboratory Improvement Amendments](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)
- [eCFR, 42 CFR 493.1236, comparison of test results](https://www.law.cornell.edu/cfr/text/42/493.1236)
- [eCFR, 42 CFR Part 493, laboratory requirements](https://www.law.cornell.edu/cfr/text/42/part-493)

## Contact

- office@neurobird.com
- https://neurobird.com/