{
  "url": "https://openlegislation.uk/independent-health-care-wales-regulations-2011/regulation-15",
  "json_url": "https://openlegislation.uk/independent-health-care-wales-regulations-2011/regulation-15.json",
  "legislation": "wsi/2011/734",
  "legislation_title": "The Independent Health Care (Wales) Regulations 2011",
  "legislation_url": "https://openlegislation.uk/independent-health-care-wales-regulations-2011",
  "path": "regulation/15",
  "kind": "regulation",
  "number": "15",
  "heading": "Quality of treatment and other service provision",
  "text": "(1) Subject to regulation 6(4), the registered person must provide any treatments and other services to patients in accordance with the statement of purpose, and must ensure that any treatments and other services provided to each patient—\n(a) meet the patient’s individual needs;\n(b) ensure the welfare and safety of the patient;\n(c) are evidence based; and\n(d) are (where necessary) provided by means of appropriate equipment.\n(2) The registered person must ensure that all equipment used in or for the purposes of the establishment or for the purposes of the agency is safe and in good condition and suitable for the purpose it is to be used for.\n(3) Where reusable medical devices are used in an establishment or for the purposes of an agency, the registered person must ensure that appropriate procedures are implemented in relation to cleaning, disinfection, inspection, packaging, sterilisation, transportation and storage of such devices.\n(4) The procedures implemented in accordance with paragraph (3) must be such as to ensure that reusable medical devices are handled safely and decontaminated effectively prior to re-use.\n(5) The registered person must protect patients against the risks associated with the unsafe use and management of medicines, by means of—\n(a) the making of appropriate arrangements for the obtaining, recording, handling, using, safe keeping, dispensing, safe administration and disposal of medicines used in or for the purposes of the establishment or agency; and\n(b) having regard to any guidance issued by the registration authority or appropriate expert body in relation to the safe handling and use of medicines.\n(6) The registered person must ensure that where blood and blood products are used a monitoring process for the safety of blood transfusion (haemovigilance) is in place.\n(7) The registered person must, so far as reasonably practicable, ensure that—\n(a) patients; and\n(b) others who may be at risk of exposure to a health care associated infection arising from working in or for the purposes of an establishment or agency,\nare protected against identifiable risks of acquiring such an infection by the means specified in paragraph (8).\n(8) The means referred to in paragraph (7) are—\n(a) the effective operation of systems designed to assess the risk of and to prevent, detect and control the spread of a health care associated infection;\n(b) where applicable, the provision of appropriate treatment for those who are affected by a health care associated infection; and\n(c) the maintenance of appropriate standards of cleanliness and hygiene in relation to—\n(i) premises occupied for the purpose of carrying on the establishment or agency;\n(ii) equipment and reusable medical devices used for the purpose of carrying on the establishment or agency; and\n(iii) materials to be used in the treatment of service users where such materials are at risk of being contaminated with a health care associated infection.\n(9) If an establishment provides food and drink for patients as a component of the patients' care, the registered person must ensure that—\n(a) Patients' nutritional and hydration needs are assessed and documented on admission and at regular intervals thereafter;\n(b) Food and hydration is provided that meets individual patient nutritional and hydration needs.\n(10) The registered person must take account of any advice bulletins relating to the type of treatment the establishment or agency provides and to patient safety information published by appropriate regulatory, professional or appropriate statutory expert bodies.",
  "extent": "E+W",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 15 in force at 5.4.2011, see reg. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/wsi/2011/734/regulation/15",
    "retrieved_at": "2026-10-28T23:51:10.955714+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."
}