Public Health Act (2021 Revision)
These Regulations restrict who may provide COVID-19 molecular testing and who may import or supply antigen rapid tests, require reporting to the Medical Officer of Health, and create offences and penalties for non-compliance.
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Public Health Act (2021 Revision)
AI-assisted research summary: These Regulations restrict who may provide COVID-19 molecular testing and who may import or supply antigen rapid tests, require reporting to the Medical Officer of Health, and create offences and penalties for non-compliance.
CAYMAN ISLANDS Public Health Act (2021 Revision) CONTROL OF COVID-19 (TESTING) REGULATIONS, 2021 (SL 72 of 2021) Supplement No. 1 published with Legislation Gazette No. 57 dated 15th October, 2021. PUBLISHING DETAILS Page 2 SL 72 of 2021 c Control of Covid-19 (Testing) Regulations, 2021 Arrangement of Regulations CAYMAN ISLANDS Public Health Act (2021 Revision) CONTROL OF COVID-19 (TESTING) REGULATIONS, 2021 (SL 72 of 2021) Arrangement of Regulations Regulation Page 1. Citation ......................................................................................................................................5 2. Definitions ..................................................................................................................................5 3. Conditions for the provision of molecular testing services for the virus .......................................6 4. Conditions for the supply of antigen-detecting rapid diagnostic tests ..........................................7 5. Offence and Penalty ..................................................................................................................8 6. Expiry ........................................................................................................................................8 c SL 72 of 2021 Page 3 Control of Covid-19 (Testing) Regulations, 2021 Regulation 1 CAYMAN ISLANDS Public Health Act (2021 Revision) CONTROL OF COVID-19 (TESTING) REGULATIONS, 2021 (SL 72 of 2021) In exercise of the powers conferred by section 34 of the Public Health Act (2021 Revision), the Cabinet makes the following Regulations — 1. Citation 1. These Regulations may be cited as the Control of Covid-19 (Testing) Regulations, 2021. 2. Definitions 2. In these Regulations — “Cayman Islands Health Services Authority” means the Cayman Islands Health Services Authority established under section 3 of the Health Services Authority Act (2018 Revision); “health care facility” means premises at which health services are provided by a registered practitioner and in respect of which a certificate is issued under section 5 of the Health Practice Act (2021 Revision); “health services” include clinical examination, nursing care, dental care, the provision of blood and blood products, diagnostic procedures, the provision of medical and surgical services, the provision of pharmaceuticals, advice or c SL 72 of 2021 Page 5 Regulation 3 Control of Covid-19 (Testing) Regulations, 2021 counselling and any other service as is provided by a registered practitioner under the Health Practice Act (2021 Revision); “manager”, in relation to a health care facility or a medical tourism facility, includes the owner; “medical tourism facility” means a health care facility designated by the Cabinet under section 7A(2) of the Health Practice Act (2021 Revision); “molecular testing” includes polymerase chain reaction testing; “registered practitioner” means any person qualified to practise any of the professions specified in the Health Practice Act (2021 Revision) and registered under the Health Practice Act (2021 Revision); and “virus” means the virus known as SARS-CoV-2 which causes the disease known as Covid-19. 3. Conditions for the provision of molecular testing services for the virus 3. (1) For the purpose of the control of the virus in the Islands, molecular testing services may only be provided by a registered practitioner, a health care facility or a medical tourism facility that receives the written approval of the Medical Officer of Health under paragraph (2) or (5). (2) Where the Medical Officer of Health notifies, by way of a notice published in the Gazette, in any other official Government website or in any other official means of communication, that there is a need for increased molecular testing capacity, a registered practitioner, a manager of a health care facility or a manager of a medical tourism facility who satisfies the requirements in paragraph (3), may apply in writing to the Medical Officer of Health to provide molecular testing services and the Medical Officer of Health shall provide written approval of the application. (3) The requirements referred to in paragraph (2) are that the relevant laboratory is one that — (a) is accredited by the Joint Commission International (JCI) or the International Organization for Standardization (ISO) or a similar accrediting organization; or (b) has reached an acceptable standard in the detection of the virus as determined by the United Kingdom’s Health Security Agency or the Pan American Health Organization, and has had its test results validated by the laboratory at the Cayman Islands Health Services Authority. (4) A registered practitioner, a manager of a health care facility or a manager of a medical tourism facility who is approved under paragraph (2) or (5) to provide molecular testing services shall report to the Medical Officer of Health, in such form as the Medical Officer of Health may specify, the result of any test for the Page 6 SL 72 of 2021 c Control of Covid-19 (Testing) Regulations, 2021 Regulation 4 virus conducted by way of molecular testing no later than twelve hours after receiving the result and the report shall include in relation to the person on whom the test was administered — (a) the full name; (b) the date of birth; (c) the sex; (d) the telephone number; (e) the email address; (f) the home address; (g) the place of work; and (h) any other relevant information which the Medical Officer of Health may request. (5) Any registered practitioner, manager of a health care facility or manager of a medical tourism facility who on the day immediately preceding the coming into force of these Regulations had received written approval from the Medical Officer of Health for the purpose of providing molecular testing for the virus is exempt from the requirement to apply for approval under this regulation and that prior approval shall be considered as an approval under paragraph (2). (6) Notwithstanding paragraph (5), a registered practitioner, a manager of a health care facility or a manager of a medical tourism facility who is exempt from the requirement to apply for approval under paragraph (2) shall comply in every other respect with these Regulations. (7) The approval granted to a registered practitioner, a manager of a health care facility or a manager of a medical tourism facility under paragraph (2) or (5) may be revoked where the Medical Officer of Health determines that there is failure to comply with the reporting requirements under paragraph (4). 4. Conditions for the supply of antigen-detecting rapid diagnostic tests 4. (1) Subject to paragraph (2), a person who, for the purpose of the control of the virus, imports into or supplies in the Islands antigen-detecting rapid diagnostic tests shall ensure that the tests are either — (a) the antigen-detecting rapid diagnostic tests — (i) which have a sensitivity of at least 80 per cent and a specificity of at least 97 per cent; and (ii) which are recommended or approved for use by a national public health agency of the United States of America, the United Kingdom, the European Union, Australia, New Zealand, Jamaica or Canada following rigorous testing and for which there is documentary evidence of this recommendation or approval; or c SL 72 of 2021 Page 7 Regulation 5 Control of Covid-19 (Testing) Regulations, 2021 (b) the antigen-detecting rapid diagnostic tests which are approved for use by the Medical Officer of Health and specified in a notice published by the Medical Officer of Health in the Gazette, in any other official Government website or in any other official means of communication. (2) An antigen-detecting rapid diagnostic test under paragraph (1) may be supplied to the public for personal use, except where the antigen-detecting rapid diagnostic test is specified as being for clinical use only. 5. Offence and Penalty 5. A person who — (a) provides molecular testing services in contravention of regulation 3; or (b) imports or supplies antigen-detecting rapid diagnostic tests in contravention of regulation 4, commits an offence and is liable on summary conviction to a fine of ten thousand dollars or to imprisonment for a term of two years, or to both. 6. Expiry 6. These Regulations cease to have effect at the end of the period of one year beginning on the day on which they come into force or at such other date as may be specified by Cabinet by notice published in the Gazette. Made in Cabinet the 15th day of October, 2021. Kim Bullings Clerk of the Cabinet Page 8 SL 72 of 2021 c
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