{
  "url": "https://openlegislation.uk/health-protection-notification-wales-regulations-2010/regulation-4C",
  "json_url": "https://openlegislation.uk/health-protection-notification-wales-regulations-2010/regulation-4C.json",
  "legislation": "wsi/2010/1546",
  "legislation_title": "The Health Protection (Notification) (Wales) Regulations 2010",
  "legislation_url": "https://openlegislation.uk/health-protection-notification-wales-regulations-2010",
  "path": "regulation/4C",
  "kind": "regulation",
  "number": "4C",
  "heading": "Duty to notify Public Health Wales of the results of genomic sequencing of mandatory test samples under the International Travel Regulations",
  "text": "(1) The operator of a sequencing laboratory must notify Public Health Wales in accordance with this regulation.\n(2) The notification must include the following information so far as it is known to the operator of the sequencing laboratory—\n(a) where the sequencing laboratory is not the source laboratory—\n(i) the name and address of the source laboratory;\n(ii) the date and time that the specimen was received by the sequencing laboratory;\n(b) a report of the results of the sequencing;\n(c) the date of that report;\n(d) a sorted BAM file containing all reads aligning to the SARS-CoV-2 reference genome with unaligned human reads removed;\n(e) any metadata required to reproduce the analysis which produced the results of the sequencing;\n(f) the following information about the specimen—\n(i) any laboratory comments;\n(ii) the organism code;\n(iii) the specimen number;\n(iv) the specimen type;\n(v) the specimen date;\n(vi) the test method applied;\n(vii) cycle threshold values;\n(viii) whether the specimen is a variant of concern or a variant under investigation.\n(3) Where the sequencing laboratory is not the source laboratory—\n(a) the notification must be provided in writing within 96 hours of receiving the specimen; and\n(b) the sequencing laboratory must—\n(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\n(ii) use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii).\n(4) Where the sequencing laboratory is the source laboratory—\n(a) the notification must be provided in writing within 120 hours of the time SAR-CoV-2 is identified in the specimen; and\n(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).\n(5) It is an offence for the operator of a sequencing laboratory to fail without reasonable excuse to comply with this regulation.\n(6) Any person who commits an offence under this regulation is liable on summary conviction to a fine.\n(7) In this regulation—\n“director of a sequencing laboratory” (“cyfarwyddwr labordy dilyniannu”) means—\n(a)the clinical microbiologist, consultant pathologist or other registered medical practitioner or other person in charge of the sequencing laboratory; or\n(b)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);\n“International Travel Regulations” (“Rheoliadau Teithio Rhyngwladol”) means the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020;\n“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;\n“Public Health Wales” (“Iechyd Cyhoeddus Cymru”) has the meaning given in regulation 4(11);\n“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;\n“source laboratory” (“labordy tarddiol”) means the diagnostic laboratory which provided the notification required by regulation 4A(1) in respect of the specimen.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 4A-4D inserted (21.9.2021) by The Health Protection (Coronavirus, International Travel and Notification) (Wales) (Miscellaneous Amendments) Regulations 2021 (S.I. 2021/1063), regs. 1(3), 11"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/wsi/2010/1546/regulation/4C",
    "retrieved_at": "2026-10-28T23:53:33.509343+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}