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

Amendment to the Health Protection (Notification) Regulations 2010 E+W

20.—(1) The Health Protection (Notification) Regulations 2010 are amended as follows.

(2) In regulation 4—

(a) after paragraph (1) insert—

“(1ZA) Where paragraph (1) of regulation 4ZA applies to the operator of a diagnostic laboratory, the notification required by paragraph (1) must be in accordance with this regulation and regulation 4ZA.”;

(b) in paragraph (3B) after “must” insert “ ,subject to paragraph (3D), ”;

(c) after paragraph (3C) insert—

“(3D) A notification which—

(a) is under paragraph (1A)(a), and

(b) relates to a day 2 or a day 8 test within the meaning of regulation 3B of the Health Protection (Coronavirus, International Travel) (England) Regulations 2020 M1 ,

must be provided in writing within 24 hours from the time the test result is known.”.

(3) After regulation 4 insert—

“Duty to notify Public Health England of the results of mandatory tests under the Health Protection (Coronavirus, International Travel) (England) Regulations 2020

4ZA.— (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.”

(4) In regulation 7(1)(a) after “4(1)” insert “ , 4ZA ”.

Commencement Information

I1 Reg. 20 in force at 15.2.2021 at 4.00 a.m., see reg. 1(1)

Marginal Citations

M1 S.I. 2020/568, amended by S.I. 2020/691, 724, 799, 805, 813, 819, 841, 866, 890, 913, 959, 980, 1013, 1039, 1070, 1076, 1094, 1129, 1161, 1190, 1227, 1238, 1277, 1292, 1323, 1337, 1360, 1424, 1517, 1595, 2021/18, 25, 38, 47, 49, 68, 98 and 137.