UKAS accredited calibration laboratory No. 10723
Pathology, blood transfusion and mortuary
A pathology department is assessed by UKAS against ISO 15189, reports to the MHRA each year on blood and is inspected on a risk basis, and is licensed by the HTA for the mortuary. At Wye Valley NHS Trust, the blood transfusion team shows assessors and inspectors the Sematics record at every visit.
4.9°C
What inspectors ask you
These are the parts of each that touch temperature.
Environmental conditions specified, monitored and recorded, including at sites away from the main lab and for point-of-care testing (6.3.1); storage that keeps samples, reagents and records intact (6.3.3); alarm systems on cold rooms and walk-in freezers checked to show they work (6.3.2 d)).
Read the guideEquipment checked against acceptance criteria before it goes into or back into service, a check that can rest on the calibration certificate (6.4.3); certificates kept in the equipment record (6.4.7 j)); measuring devices calibrated with traceability (6.5), traceable or UKAS accredited. Assessors check the certificates.
Read the guideBSQR 2005 requires validated storage and full traceability, with records the MHRA can inspect for every unit. The red cell (+2 to +6 °C) and platelet (+20 to +24 °C) ranges are set in law, in BSQR Schedule Part 4, and repeated in the UK Blood Transfusion Services Red Book. Plasma at a core temperature of −25 °C or below comes from the Red Book (7.5.1).
Fridges and freezers in good working order, temperatures monitored, and alarms that are tested and reach someone out of hours.
For your next assessment
| Control | ISO 15189 | BSQR (with the Red Book) | HTA |
|---|---|---|---|
| Temperatures monitored and recorded | ✓ | ✓ | ✓ |
| Continuous recording with alarms (our recommendation) | · | ✓ | · |
| Calibration traceable to national standards | ✓ | ✓ | ✓ |
| Excursion investigation on record | ✓ | ✓ | ✓ |
| Records reviewed and signed off | ✓ | ✓ | · |
A summary to plan with, not official guidance.
Setting alarms inside the range by the probe's uncertainty applies the same guard-band idea UKAS LAB 48 uses for conformity decisions.
From the trust's published case study.
1.1 min
median time to acknowledge an alarm at one NHS health board in 2026
What we monitor
Limits set to the component, alarms to the on-call biomedical scientist, and every excursion recorded with the action taken.
Held at 20 to 24 °C (a core temperature of 22 ±2 °C) with continuous gentle agitation, as the Red Book asks (7.4.1), with the temperature alarm history the MHRA inspector asks for.
Storage for reagents, controls and samples, plus room temperature where analysers need it.
Fridges and freezers monitored around the clock, so a failure is found before it becomes an incident.
Healthcare and NHS
Every
visit by assessors and inspectors at Wye Valley NHS Trust includes a look at the Sematics record
“They always come and they always look at the Sematics system and they're always happy with what we do.”
Regulation: ISO 15189 and UKAS assessments
Read the Wye Valley NHS Trust storyServices for this sector
Wireless sensors, alarms that reach a person and an audit trail of who acted.
Explore the serviceTemperature calibration in our UKAS accredited calibration laboratory No. 10723, or on your site.
Explore the serviceHardware IQ and OQ, the platform validated by Sematics, and your URS, DQ and PQ.
Explore the serviceA managed study, from protocol to report, with probe positions you can defend.
Explore the serviceFree checklist
One page on what a UKAS assessor looks for: storage conditions, equipment, calibration certificates and how you handle an excursion.
Questions
Usually: how limits were set, what happens when an alarm goes off out of hours, who acted, and whether the sensors are calibrated with traceable certificates. The ISO 15189 explainer goes through it clause by clause.
Our laboratory No. 10723 is UKAS accredited for temperature calibration, from −90 to +135 °C in a dry block and −35 to +40 °C in an air chamber, in the lab and on site. Other parameters go through accredited partners.
Yes, together with your blood tracking or LIMS record. That shows which fridge a unit was in and when, and the monitoring record shows the conditions, alarms and actions for that fridge over that time.
Yes. We can map the new rooms as a managed service, place the monitoring on the results and move sensors with the equipment, so your records don't break during the move.
The BSQR and the Red Book name no medium. BS 4376-1:1991, the British Standard for building and testing blood refrigerators, puts the sensor for the temperature record in a thermal mass equal to 200 mL of water and does not mention glycerol, and we found no published evidence that glycerol represents blood better. We recommend water at 200 mL equivalent in a standardised container, or a validated block, tested in your own fridge. The evidence is in our guide to blood product simulants.
20-minute compliance check
In 20 minutes we go through storage, alarms, calibration and excursions with you, across pathology, blood and mortuary. You get the gaps in writing. No product tour.