Legislation – The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021

“Duty to notify Public Health England of the results of mandatory tests under the Health Protection (Coronavirus, International Travel) (England) Regulations 20204ZA.

(1)

This regulation applies to the operator of a diagnostic laboratory where—

(a)

the laboratory processes a day 2 test within the meaning of regulation 3B of the Health Protection (Coronavirus, International Travel) (England) Regulations 2020 (“the 2020 Regulations”),

(b)

the operator is required to send a notification in relation to the test in accordance with regulation 4(1)(a) of these Regulations, and

(c)

the test provider is required to sequence the test sample under paragraph 6(1)(e) of Schedule 2C to the 2020 Regulations.

(2)

The notification required by regulation 4(1)(a) must, in addition to the information listed in regulation 4(2), include the following information so far as it is known to the operator of the diagnostic laboratory—

(a)

name and address of the source laboratory (if different from the diagnostic laboratory);

(b)

the date of the laboratory report;

(c)

the following information about the person (“P”) from whom the sample was taken—

(i)

P’s age in months and years;

(ii)

P’s address and postcode;

(iii)

P’s occupation;

(iv)

whether or not P is immunocompromised;

(v)

whether or not P has received a vaccine against SARS-CoV-2;

(d)

the following information about the sample—

(i)

any laboratory comments;

(ii)

the organism code;

(iii)

the specimen number;

(iv)

the specimen type;

(v)

the specimen date;

(vi)

the test method applied;

(vii)

cycle threshold values;

(viii)

whether the sample is a variant of concern or a variant under investigation;

(ix)

where the sample has been sequenced, a sorted BAM file containing all reads aligning to the SARS-CoV-2 reference genome with unaligned and human reads removed.”