GP spirometry results may be unreliable: recovering quality

If spirometry results may be unreliable after an operator or equipment change, stop relying on them for diagnosis, identify the affected patients, review the diagnoses and treatment that depended on them, and restore quality-assured testing before resuming diagnostic use.

What has happened

A practice realises its spirometry may not be reliable: an operator was not currently competent to the quality-assured standard, a device was out of calibration or faulty, or a quality review found poor-quality traces. Because spirometry drives diagnoses of COPD and asthma and treatment decisions, unreliable results can cause real clinical harm. National quality assurance through the PCRS/ARTP certification and national register and NHS England's spirometry commissioning guidance exist precisely to keep diagnostic spirometry quality-assured.

Immediate actions

Stop relying on the suspect spirometry for diagnosis. Define the scope: which operator, which device, and over what period results may be affected. Check the equipment's calibration and maintenance status and the operator's current quality-assured competence. Identify the patients whose diagnosis or treatment relied on results in the affected window, and decide clinically which need re-testing with quality-assured spirometry and which diagnoses or treatments need review. Arrange quality-assured testing (in-house once restored, or via referral) so patient care continues.

What not to do

Do not keep issuing or acting on results you no longer trust, and do not assume a plausible-looking trace is valid. Do not narrow the review to one patient if the cause (operator or device) affects many. Do not resume diagnostic spirometry before competence and calibration are restored, and do not leave affected patients unreviewed.

Who is responsible

The practice's clinical lead (often a GP partner) and practice manager are responsible for the quality-recovery plan, patient review and restoring quality-assured testing; the clinician(s) responsible for each affected patient make the individual clinical decisions. Operators must hold current quality-assured competence, and the practice ensures equipment is calibrated and maintained.

Evidence and records

Record the quality concern and how it was identified, the affected operator/device/period, the equipment calibration and operator competence position, the list of affected patients and the review outcomes (re-test, diagnosis revised, no change), and the steps taken to restore quality-assured testing. Log it as a significant event for learning.

Escalation

Escalate through the practice's significant-event and clinical-governance process, and where a patient may have been harmed by misdiagnosis, follow duty-of-candour and any complaint or incident route. Coordinate re-testing capacity with the local respiratory pathway or a quality-assured service. Where the issue reflects a wider records or safety-alert problem, use the same discipline as a medicines safety-alert patient search.

Prevention

Only let operators with current quality-assured competence perform diagnostic spirometry, keep equipment on a calibration and maintenance schedule, quality-check traces routinely, and track operator certification renewal on the national register. A live competence-and-calibration record catches a lapse before it produces a run of unreliable results.

Where Complys can help

Complys can hold staff competence and certification records, equipment calibration and maintenance schedules, and the significant-event and action log, keeping the quality-recovery trail together for CQC. It does not perform spirometry or make clinical decisions about patients; the practice's clinicians do. Ask the Complys team to show how competence and equipment records are tracked.