2021-03-21 18:54:10
Last year, COVID-19 was added to the list of notifiable diseases in Schedule 1 to the Health Protection (Notification) Regulations 2010. This Schedule lists diseases that doctors must notify to Public Health England if a case is detected in a patient. The addition of COVID-19 to the list did not have any immediate significance for pharmacies, because the GPhC had banned pharmacies from selling lateral flow tests.
On 15 February 2021, the GPhC changed its position, allowing pharmacies to sell lateral flow tests. This brought Regulation 4A of the Health Protection (Notification) Regulations into play.
Regulation 4A imposes a duty on point of care test providers to notify Public Health England of the results of tests for the detection of the SARS-CoV-2 virus or influenza virus. A “point of care test” is a defined as a diagnostic test which is not carried out in a diagnostic laboratory. A “test provider” is defined very widely and would include any pharmacy carrying out point of care tests for the detection of SARS-CoV-2 or influenza virus.
Notification to Public Health England can be made electronically and must be made in writing within 24 hours of the time when a positive or indeterminate SARS-CoV-2 test result is received by the test provider. If the test is negative or void, notification must be made within seven days. In the case of influenza virus, notification must be made within seven days of the test result being received by the test provider.
The details to be notified include, insofar as they are known to the test provider, the patient’s name, sex, date of birth, NHS number, ethnicity, current address (including postcode), and, in the case of a test for SARS-CoV-2 that is positive or indeterminate, a telephone number and email address The test provider must notify its name, the nature of the establishment, specimen identification number (if applicable), specimen type, specimen date, test method, result of test, date on which the test was carried out, and the name of the testing equipment manufacturer.
Failure to notify in accordance with the Regulations without reasonable excuse is an offence punishable on summary conviction by a fine.