A shared record of what analyser changes do to patient results.

For each change a laboratory makes, the Registry keeps two things: the paired results the laboratory already produced for its own verification (the same sample measured on the old and the new system), and a short change record: old and new analyser, reagent and calibrator lot where known, software version, the month the new system went live, and the laboratory’s own decision limits.

From many such records it answers two questions no single laboratory can:

• Before a change: what did this same pair of systems do to results at the decision limits in other laboratories?
• After a change: how does our bias, and our count of results crossing each limit, compare with every laboratory that made the same or a similar change?

Holders of data from devices used in trials can contribute device changes in the same way, as a change record and aggregates computed on their own systems. Per-person data is designed to stay with the holder.

Contributing is optional and separate from the report. The analyser-change report runs inside your laboratory and the files that leave it are designed to carry only aggregates (see security and data handling). Contributing to the Registry is a further step a laboratory can choose, by opting in on its order form, by signing a one-page accession form, or by sending the derived summary the change check shows (it reaches our mailbox by email, processed in the United States). It is never a condition of the report.

A contributing laboratory chooses one of two routes for each change:

• Coded pairs. Your own staff remove every identifier and replace each sample number with a random code of which no key is kept. Each row then holds only the analyte, its unit, the old and the new value, the sample type and, if you choose, the care setting. This route is for the Registry only. A study with an EQA scheme takes no participant-level rows: the scheme runs the code and releases what it chooses.
• Aggregates only. The totals the report’s program already produces in your laboratory, with small counts suppressed, and the change record. Send one set of totals per change: totals from overlapping data sent twice can reveal more than either set alone.

Never contributed: names, identity numbers, dates of birth, age, sex, the date or time of a draw, ward, requester, diagnosis, free text, or routine results outside the comparison.

Your data protection officer decides. If any row or field would be personal data in our hands, it is not contributed, and we agree a coarser version, such as aggregates only.

The first laboratories to join become founding laboratories. Each will hold a seat on the Registry’s steering group, which will meet at least twice a year and decide, by majority, the minimum cell sizes (which it can raise but never lower), what a registry row contains, the publication plan, and requests from academic researchers. Founding laboratories are named as such only if they agree to it.

Ask for the founding terms

The Registry is held by NakedSignal, which also chairs the steering group. A laboratory that contributes gives us a licence to use its rows, change records and summaries for this work, and what is already built keeps it after the laboratory stops. We use the pooled record to build and improve methods, software and models that size analyser changes, we own what we build, and we may license it to others. We never sell or license registry rows as rows, never try to identify a person, and never combine rows with other data for that purpose. Rows go only where the charter allows: to a company in our own group, to a new owner of our business, to a subcontractor bound by the same terms, or to a regulator reviewing our products.

If the business the Registry belongs to passes to another owner, the Registry, its rows and the licences laboratories gave would then pass to the new owner without a new consent, but only if the new owner agrees in writing to keep every promise on this page and in the charter, including the right to stop. We tell contributing laboratories within 30 days. Passing the Registry to a new owner in this way is not a sale of rows.

No rows are held yet. The charter sets how rows will be held once laboratories contribute: rows from the EU or EEA stored and processed there, rows from the UK in the UK or the EU or EEA, encrypted storage, and access limited to named staff with a record of each access. These are planned, not in place today. The full charter is sent on request.