Insertion of new regulations 4A, 4B, 4C and 4D
11. After regulation 4 insert—
“Duty on the operators of diagnostic laboratories to notify Public Health Wales of SARS-CoV-2 or influenza virus tests processed
4A.—(1) The operator of a diagnostic laboratory must notify Public Health Wales in accordance with this regulation where the diagnostic laboratory processes a test for the detection of SARS-CoV-2 and the test result is positive or indeterminate.
(2) Where paragraph (1) of regulation 4B applies to the operator of a diagnostic laboratory, the notification required by paragraph (1) must be in accordance with this regulation and regulation 4B.
(3) The operator of a diagnostic laboratory must also notify Public Health Wales in accordance with this regulation where the diagnostic laboratory—
(a)processes a test for the detection of SARS-CoV-2 and the test result is negative or void; or
(b)processes a test for the detection of influenza virus and the test result is positive, indeterminate, negative or void.
(4) The notification must include the following information insofar as it is known to the operator of the diagnostic laboratory—
(a)the name and address of the diagnostic laboratory;
(b)the date and time the sample was received by the diagnostic laboratory;
(c)where a causative agent is identified, the details of that agent;
(d)the date of the sample;
(e)the nature of the sample;
(f)the results of any antimicrobial susceptibility test and any resistance mechanism identified in respect of the sample;
(g)name of person (“P”) from whom the sample was taken;
(h)P’s date of birth and sex;
(i)P’s current home address including postcode;
(j)P’s current residence (if not home address);
(k)P’s ethnicity;
(l)P’s NHS number;
(m)the name, address and organisation of the person who solicited the test;
(n)where the test is for the detection of SARS-CoV-2 or influenza virus, the result of the test; and
(o)where the result of a test for the detection of SARS-CoV-2 is positive or indeterminate, a telephone number and an email address—
(i)where P is a child or a person with a disability who is unable for that reason to provide the information set out in sub-paragraphs (e) to (j), for an appropriate parent, guardian or carer of that person;
(ii)otherwise, for P.
(5) Subject to paragraph (7), a notification under paragraph (3) must be provided in writing within 7 days beginning with the day on which the diagnostic laboratory becomes aware of the test result.
(6) Subject to paragraph (7), a notification under paragraph (1) must be provided in writing within 24 hours of the diagnostic laboratory becoming aware of the test result.
(7) A notification which—
(a)is under paragraph (1) or (3); and
(b)relates to a day 2 or a day 8 test within the meaning of regulation 6AB of, the International Travel Regulations,
must be provided within 48 hours of the time the diagnostic laboratory received the test sample.
(8) Without prejudice to paragraph (5), if the operator of the diagnostic laboratory considers that a particular case to which that paragraph applies is urgent, the notification must be provided orally as soon as reasonably practicable.
(9) For the purpose of this regulation, a diagnostic laboratory processes a test where—
(a)the diagnostic laboratory processes the test; or
(b)the test is processed by another laboratory under an arrangement made with that diagnostic laboratory.
(10) Where paragraph (9)(b) applies—
(a)the day on which the diagnostic laboratory becomes aware of the test result for the purposes of paragraph (3) is the day on which the diagnostic laboratory became aware of the result of the test processed by that other laboratory;
(b)the time at which the diagnostic laboratory becomes aware of the test result for the purposes of paragraph (1) is the time at which the diagnostic laboratory became aware of the result of the test processed by that other laboratory.
(11) It is an offence for the operator of a diagnostic laboratory to fail without reasonable excuse to comply with this regulation.
(12) Any person who commits an offence under this regulation is liable on summary conviction to a fine.
(13) In this regulation—
“carer” (“gofalwr”) has the meaning given in section 3 of the Social Services and Well-being (Wales) Act 2014(1);
“child” (“plentyn”) has the meaning given in regulation 2(7);
“diagnostic laboratory” (“labordy diagnostig”) has the meaning given in regulation 4(11);
“disability” (“anabledd”) has the same meaning as in the Equality Act 2010(2) (see section 6 of, and Schedule 1 to, that Act);
“guardian” (“gwarcheidwad”) has the meaning given in section 107 of the Children and Young Persons Act 1933(3);
“International Travel Regulations” (“Rheoliadau Teithio Rhyngwladol”) means the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020;
“operator of a diagnostic laboratory” (“gweithredwr labordy diagnostig”) has the meaning given in regulation 4(11);
“parent” (“rhiant”) has the meaning given in regulation 2(7);
“Public Health Wales” (“Iechyd Cyhoeddus Cymru”) has the meaning given in regulation 4(11).
Duty to notify Public Health Wales of the results of mandatory tests under the International Travel Regulations
4B.—(1) This regulation applies to the operator of a diagnostic laboratory where—
(a)the laboratory processes a day 2 test or a day 8 test (within the meaning of regulation 6AB of the International Travel Regulations);
(b)the operator is required to send a notification in relation to the test in accordance with regulation 4A of these Regulations; and
(c)the operator is required to sequence the test sample under paragraph 1ZA or 2ZA of Schedule 1C to the International Travel Regulations.
(2) The notification required by regulation 4A(1) must, in addition to the information listed in regulation 4A(3), 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, including the laboratory’s five-letter unique identifier code;
(iv)the specimen type;
(v)the specimen date;
(vi)the test method applied;
(vii)cycle threshold values.
(3) Where the specimen is to be sent to another laboratory for the purposes of sequencing pursuant to paragraph 1ZA or 2ZA of Schedule 1C to the International Travel Regulations, the operator of the diagnostic laboratory must provide that other laboratory with the specimen number used to fulfil the obligation in paragraph (2)(d)(iii).
(4) In this regulation, “diagnostic laboratory”, “International Travel Regulations”, “operator of a diagnostic laboratory” and “Public Health Wales” have the same meaning as in regulation 4A(13).
Duty to notify Public Health Wales of the results of genomic sequencing of mandatory test samples under the International Travel Regulations
4C.—(1) The operator of a sequencing laboratory must notify Public Health Wales in accordance with this regulation.
(2) The notification must include the following information so far as it is known to the operator of the sequencing laboratory—
(a)where the sequencing laboratory is not the source laboratory—
(i)the name and address of the source laboratory;
(ii)the date and time that the specimen was received by the sequencing laboratory;
(b)a report of the results of the sequencing;
(c)the date of that report;
(d)a sorted BAM file containing all reads aligning to the SARS-CoV-2 reference genome with unaligned human reads removed;
(e)any metadata required to reproduce the analysis which produced the results of the sequencing;
(f)the following information about the specimen—
(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 specimen is a variant of concern or a variant under investigation.
(3) Where the sequencing laboratory is not the source laboratory—
(a)the notification must be provided in writing within 96 hours of receiving the specimen; and
(b)the sequencing laboratory must—
(i)ascertain the specimen number that the source laboratory used to fulfil its obligation in regulation 4B(2)(d)(iii) in respect of the specimen; and
(ii)use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii).
(4) Where the sequencing laboratory is the source laboratory—
(a)the notification must be provided in writing within 120 hours of the time SARS-CoV-2 is identified in the specimen; and
(b)the sequencing laboratory must use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii) as it used to fulfil the obligation in regulation 4B(2)(d)(iii).
(5) It is an offence for the operator of a sequencing laboratory to fail without reasonable excuse to comply with this regulation.
(6) Any person who commits an offence under this regulation is liable on summary conviction to a fine.
(7) In this regulation—
“director of a sequencing laboratory” (“cyfarwyddwr labordy dilyniannu”) means—
the clinical microbiologist, consultant pathologist or other registered medical practitioner or other person in charge of the sequencing laboratory; or
any other person working in the sequencing laboratory to whom the function of making a notification under this regulation has been delegated by the person mentioned in paragraph (a);
“International Travel Regulations” (“Rheoliadau Teithio Rhyngwladol”) means the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020;
“operator of a sequencing laboratory” (“gweithredwr labordy dilyniannu”) means the corporate body that operates the sequencing laboratory or, if there is no such body, the director of the sequencing laboratory;
“Public Health Wales” (“Iechyd Cyhoeddus Cymru”) has the meaning given in regulation 4(11);
“sequencing laboratory” (“labordy dilyniannu”) means a laboratory which sequences a sample pursuant to paragraph 1ZA or 2ZA of Schedule 1C to the International Travel Regulations;
“source laboratory” (“labordy tarddiol”) means the diagnostic laboratory which provided the notification required by regulation 4A(1) in respect of the specimen.
Duty on test providers to notify results of point of care tests for the detection of SARS-CoV-2 or influenza virus to Public Health Wales
4D.—(1) This regulation applies where a test provider carries out on a person (“P”) a valid point of care test for the detection of SARS-CoV-2 or influenza virus.
(2) For the purposes of this regulation—
(a)a point of care test is a diagnostic test which is not carried out in a diagnostic laboratory; and
(b)a point of care test is valid if it is carried out in accordance with the instructions provided by the manufacturer of the testing equipment.
(3) The test provider must notify Public Health Wales of the result of the test, in accordance with paragraphs (4) to (6).
(4) A notification must be provided in writing—
(a)within 24 hours of the time when the test result is received by the test provider, in the case of the result of a test for the detection of SARS-CoV-2 being positive or indeterminate;
(b)within 7 days beginning with the day on which the test result is received by the test provider, in the case of—
(i)the result of a test for the detection of SARS-CoV-2 being negative or void; or
(ii)the result of a test for the detection of influenza virus.
(5) A notification must include the following information, insofar as it is known to the test provider—
(a)in relation to P, their—
(i)first name;
(ii)surname;
(iii)sex;
(iv)date of birth;
(v)NHS number (if known);
(vi)ethnicity;
(vii)current address (including postcode);
(viii)telephone number, where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate;
(ix)email address, where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate;
(b)in relation to the test, the—
(i)name of the test provider;
(ii)nature of the establishment;
(iii)specimen identification number (if applicable);
(iv)specimen type;
(v)specimen date;
(vi)test method;
(vii)result of test;
(viii)date on which the test was carried out;
(ix)name of the testing equipment manufacturer.
(6) Where P is a child, or a person with a disability who is unable for that reason to provide the information set out in paragraph (5)(a) to the test provider, the test provider must provide Public Health Wales with, insofar as it is known to the test provider—
(a)the information set out in paragraph (5)(a)(i) to (vii) in relation to P, having obtained it from an appropriate parent, guardian or carer of P (“X”); and
(b)where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate, X’s telephone number and email address.
(7) It is an offence for a test provider to fail without reasonable excuse to comply with this regulation.
(8) A test provider that commits an offence under this regulation is liable on summary conviction to a fine.
(9) In this regulation, “test provider” means a company, partnership, charity, corporation, unincorporated association, or other organisation or body, whether public or private, or sole trader, carrying out point of care tests for the detection of SARS-CoV-2 or influenza virus.
(10) In this regulation, “International Travel Regulations” and “Public Health Wales” have the same meaning as in regulation 4A(13).”
1933 c. 12, amended by paragraph 7(a) of Schedule 13 to the Children Act 1989 (c. 41), section 64 of, and Schedule 5 to, the Children and Young Persons Act 1963 (c. 37) and paragraph 1 of Schedule 7 to the Licensing Act 2003 (c. 17); there are other amending instruments, but none are relevant.