Standard 53: Allergology

Sample. Review the allergy history records of a random sample of patients who received a drug or product in the last 3 months.

1. An allergy history is recorded before the first drug or product is given.

Method. Compare the time of the first administration with the time the allergy history was recorded, for each sampled patient.

Evidence to show. Allergy history taking and recording (ALR-SOP-001); allergy history record (ALR-FRM-001).

Pass when. Every sampled patient has an allergy history recorded before the first administration.

2. The record covers the agent, the reaction and its severity.

Method. Check each sampled allergy entry for the three elements.

Evidence to show. Allergy history record (ALR-FRM-001).

Pass when. Every sampled allergy entry records the agent, the reaction and the severity.

3. The history is checked at each new prescription.

Method. Check the dates of the checks against the dates of new prescriptions for the sample.

Evidence to show. Medicines management policy (HOS-POL-001, existing, reused); allergy history record (ALR-FRM-001).

Pass when. Every sampled new prescription has a recorded check of the allergy history.

Immediate fail (any one means the criterion is not met)

• A patient with a known penicillin reaction is given amoxicillin because the allergy was never recorded.

Sample. Review every anaphylaxis episode in the last 12 months, and the daily kit checks for the same period.

1. Anaphylaxis is treated at once with adrenaline under the written protocol.

Method. Check each recorded episode for the time of recognition and the time of the first adrenaline dose.

Evidence to show. Anaphylaxis recognition and treatment (ALR-SOP-002); anaphylaxis and emergency response in procedure units (PRO-SOP-004, existing, reused).

Pass when. Every recorded episode has adrenaline given at once, or a recorded reason.

2. Adrenaline and the emergency kit are stocked, checked and in date.

Method. Check the daily record and the expiry dates for the sample period.

Evidence to show. Anaphylaxis episode and adrenaline check register (ALR-REG-001); resuscitation area readiness (ED-POL-002, existing, reused).

Pass when. Every daily check is recorded, and the adrenaline is in date on every check.

3. Each episode is recorded and reviewed.

Method. Check each episode for the record and the review.

Evidence to show. Adverse reaction record (PRO-FRM-006, existing, reused).

Pass when. Every episode has a record and a review.

Immediate fail (any one means the criterion is not met)

• A patient in clinic develops anaphylaxis, and the adrenaline in the kit expired four months earlier.

Sample. Review the quality control and result records for the sample period, and the external assessment results.

1. Each test run includes controls that pass before results are reported.

Method. Check each sampled run for the positive and negative control results before the report date.

Evidence to show. Internal quality control (LBT-SOP-002, existing, reused); internal quality control log (LBT-REG-003, existing, reused).

Pass when. Every sampled run has passing controls before its results were reported.

2. Results are interpreted by a qualified clinician with the clinical history.

Method. Check each sampled result for the interpretation and the signing clinician.

Evidence to show. Allergy test result and interpretation record (ALR-FRM-002).

Pass when. Every sampled result has a clinician interpretation that uses the clinical history.

3. The laboratory takes part in external quality assessment.

Method. Check the external assessment results for the period.

Evidence to show. External quality assessment results register (LBT-REG-004, existing, reused).

Pass when. The laboratory took part in each external assessment in the period, with results recorded.

Immediate fail (any one means the criterion is not met)

• A skin test run with a failed positive control is reported, and a patient is wrongly told they are not allergic.

Sample. Review all immunotherapy patients in the last 12 months, with their eligibility, consent and dose records.

1. Immunotherapy starts only after the written eligibility criteria are met.

Method. Check each sampled patient for the eligibility record before the first dose.

Evidence to show. Allergen immunotherapy protocol (ALR-POL-001).

Pass when. Every sampled patient met the criteria before the first dose.

2. Informed consent is recorded before the first dose.

Method. Check each sampled patient for the consent record.

Evidence to show. Informed consent before significant care (CON-SOP-001, existing, reused).

Pass when. Every sampled patient has recorded consent before the first dose.

3. Each dose follows the escalation with observation time and emergency equipment.

Method. Check the dose and observation records for a sample of doses.

Evidence to show. Immunotherapy dose and observation record (ALR-FRM-003).

Pass when. Every sampled dose follows the schedule, with observation time recorded and equipment available.

Immediate fail (any one means the criterion is not met)

• A patient receives a dose above the schedule and is discharged after 5 minutes of observation.

Sample. Review allergy results and action plans for a sample of patients in the last 6 months, and the allergy alerts on their records.

1. Each result and its advice is communicated to the patient and the referrer.

Method. Check each sampled result for the record of communication.

Evidence to show. Allergy results communication and action plan (ALR-SOP-004); critical result reporting (HOS-SOP-009, existing, reused).

Pass when. Every sampled result has a recorded communication to the patient and the referrer.

2. Each patient has a written action plan.

Method. Check each sampled patient for the action plan.

Evidence to show. Allergy action plan (ALR-FRM-004).

Pass when. Every sampled patient has a written action plan.

3. The allergy alert is updated when a result changes the history.

Method. Check each sampled result that changed the history against the alert on the record.

Evidence to show. Laboratory report content and delivery (LBT-SOP-008, existing, reused); allergy history record (ALR-FRM-001).

Pass when. Every changed history has an updated alert on the record.

Immediate fail (any one means the criterion is not met)

• A new allergy is confirmed by testing, but the alert on the record is never updated.