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Public Health (Corona Sampling and Testing) Regulations, 5781-2021

תקנות בריאות העם (דיגום וביצוע בדיקות קורונה), תשפ"א-2021

Published: 2021-08-05Consolidated Hebrew text as of 2024-02-29 · Last amended 2023-03-09
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Unofficial English translation — for reference only. It may contain errors or omissions and cannot be relied on as a legal text. Only the Hebrew text published in Reshumot is legally binding.More

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The Hebrew text as published in Reshumot (ספר החוקים) and on the Knesset website is the sole authoritative and legally binding version. In any discrepancy, the Hebrew text prevails.

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By virtue of my authority under Section 36 of the Public Health Ordinance, 1940 (hereinafter – the Ordinance), and with the approval of the Labour, Welfare and Health Committee of the Knesset pursuant to subsection 2(b) of the Penal Law, 5737-1977, I hereby promulgate the following Regulations:

Chapter I: Definitions

Definitions§

1.

In these Regulations –

"corona testing site" – a testing site at which a rapid corona test is conducted, including sampling and receipt of the results of such a test; such a site may be mobile; for the purpose of a remotely supervised home self-test, such a site shall be the site at which remote samplers operate;

"test" – any of the following:

(1)a corona test;
(2)a rapid corona test;

"remotely supervised home self-test" – a test supervised by means of communication enabling the real-time transmission of image and sound, between a remote sampler and a person being tested pursuant to Section C of Chapter III, and in the case of a test that is not a rapid corona test, sampling supervised as aforesaid;

"serological test" – a serological test for the detection of antibodies to SARS-CoV2;

"corona test" – a test for SARS-CoV2;

"rapid corona test" – a corona test or a serological test, the results of which are obtained on-site within not more than thirty minutes, including a rapid corona test that is a remotely supervised home self-test;

"samples" – samples originating from human beings for the purpose of conducting a test;

"sampler" – a person who performs sampling operations and has been granted authorisation pursuant to regulation 11, including a remote sampler;

"remote sampler" – a person who performs remote supervision over a person conducting a remotely supervised home self-test and has been granted authorisation pursuant to regulation 11;

"sampling" – the taking of samples;

"the Director" – the Director General of the Ministry of Health or a person authorised by him for the purposes of these Regulations;

"operator of a corona testing site" – a person whose occupation is the operation of a corona testing site;

"operator of a collection point" – a person whose occupation is the operation of a collection point, including a collection point for a remotely supervised home self-test;

"medical manager" – a person appointed as the responsible manager of a corona testing site pursuant to regulation 8;

"base profession" – (Repealed)

"registry" – the registry of operators of corona testing sites or the registry of operators of collection points, as the case may be, maintained pursuant to regulation 2;

"medical laboratory worker" – one of the following:

(1)a laboratory manager, as defined in the Laboratory Regulations;
(2)a senior medical laboratory worker, as defined in the Laboratory Regulations;
(3)a medical laboratory worker holding a permanent certificate pursuant to regulation 62e(d) of the Laboratory Regulations, with three years of experience working in a medical laboratory;

"registered in the registry" – a person who has received a registration certificate as referred to in regulation 4 and whose registration remains valid and has not been cancelled or suspended, as referred to in regulations 5 and 7;

"collection point" – a collection point at which samples are taken and collected for the purpose of their transfer to a laboratory for testing;

"the Laboratory Regulations" – the Public Health (Medical Laboratories) Regulations, 5737-1977.

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Chapter II: Registration of an Operator of a Testing Site or Collection Point

Maintenance of the Registry§

2.
(a)The Director shall maintain a registry of operators of corona testing sites and operators of collection points, which shall include the particulars of the operators who have been registered, including the particulars of the medical manager as well as particulars regarding the cancellation, suspension or conditioning of the registration of an operator of a corona testing site or an operator of a collection point.
(b)The registry shall be open for public inspection on the website of the Ministry of Health.

Obligation to Register§

3.
(a)A person shall not operate a corona testing site by way of occupation unless that person is registered in the registry.
(b)A person shall not operate a collection point by way of occupation unless that person is registered in the registry.
(c)A person who meets all of the following conditions is entitled to be registered in the registry:
(1)the person is an adult or is a corporation registered under law in Israel;
(2)the operator of the corona testing site or the operator of the collection point, as the case may be, has appointed a medical manager;
(3)in the case of an operator of a collection point – the person has entered into a written agreement with a recognised medical laboratory registered pursuant to the Laboratory Regulations and reporting to the Ministry of Health pursuant to those Regulations, for the purpose of receiving the samples in order to conduct a test and to receive results.
(d)The Director may add further conditions for an operator of a corona testing site or collection point, including conditions regarding the location of the conduct of tests, as a condition for registration; such conditions shall be published on the website of the Ministry of Health.

Application for Registration§

4.
(a)An operator of a corona testing site or collection point shall be registered on the basis of a declaration submitted to the Director, in the form set out in Part 1 of the First Schedule; where the applicant has submitted the declaration and the documents referred to in sub-regulation (b), the Director shall provide the applicant with a written confirmation of receipt thereof together with any additional conditions as referred to in regulation 3(d), if added, and the operator of the corona testing site or collection point in respect of which the application was submitted shall be deemed to be an operator of a corona testing site or collection point registered in the registry, and the confirmation shall serve as evidence thereof; the Director may refuse to register an operator of a corona testing site or collection point if the Director finds that the conditions for registration in the registry pursuant to sub-regulation 3(c) have not been met.
(b)The following shall be attached to an application for registration:
(1)a declaration in the form set out in Part 1 of the First Schedule, signed by the operator of the corona testing site and authenticated by a lawyer, and if the operator of the corona testing site is a corporation – signed by an authorised signatory thereof and authenticated by a lawyer;
(2)the name of the medical manager appointed and contact details for that person;
(3)a confidentiality undertaking form for the preservation of the confidentiality of matters relating to persons being tested that come to their knowledge in the course of operating the corona testing site or collection point, as the case may be, signed by the operator of the testing site or collection point and the medical manager, and if the operator of the corona testing site is a corporation – signed by an authorised signatory thereof; the Director shall publish a specimen of such a form on the website of the Ministry of Health;
(4)consent to the disclosure of criminal information in the form detailed in the Second Schedule.

Validity of Registration§

5.

The validity of a registration in the registry shall not exceed one year from the date of registration, and the Director may renew the validity of the registration for additional periods not exceeding one year each, from the date of expiry of the registration in the registry; renewal of the registration shall be granted on the basis of a declaration to be submitted by the operator of the testing site or collection point in the form set out in Part 2 of the First Schedule; where the operator of the testing site or collection point has submitted a declaration as referred to in this regulation, the provisions of regulation 4(a) shall apply with the necessary modifications.

Restriction on Registration§

6.
(a)The Director may, by a reasoned decision in writing, refuse to register an operator of a corona testing site or an operator of a collection point, or cancel a registration that was granted, if the operator of the testing site or the operator of the collection point has been convicted of an offence which, by reason of its nature, gravity or circumstances, renders that person unfit to serve as an operator of a corona testing site or collection point, and if that person is a corporation – a senior office holder therein has been convicted as aforesaid; in this regulation, "senior office holder" – the general manager of the corporation or a medical manager in the corporation.
(b)A decision pursuant to sub-regulation (a) shall not be made unless the applicant for registration or the operator of the testing site or collection point, as the case may be, has been given an opportunity to state their arguments before the Director.

Cancellation of Registration§

7.
(a)The Director may cancel the registration of an operator of a testing site or collection point, condition it or suspend it for a period as directed, if the Director finds that any of the following has occurred:
(1)the registration was obtained on the basis of a false declaration, including a declaration containing misleading, erroneous or partial information;
(2)the operator of the testing site or collection point has not complied with a provision of these Regulations or a provision of another enactment in connection with the operator's occupation as an operator of a corona testing site or collection point, or with instructions given to the operator by the Director;
(3)a condition for registration in the registry has ceased to be fulfilled;
(4)the operator of the corona testing site or collection point has displayed a lack of competence, deficient qualifications or insufficient professional knowledge, in a manner that may cause harm to public health or result in corona tests being conducted at an inadequate standard;
(5)the operator of the corona testing site or collection point has breached a condition of registration.
(6)Without prejudice to the provisions of this regulation, an operator of a corona testing site who operates a remotely supervised home self-test or an operator of a collection point, and who does not operate in accordance with the international information security standards ISO27001:2013 and ISO277799 regarding medical information.
(b)The Director shall not cancel or suspend the registration of an operator of a testing site or collection point unless the operator has been given an opportunity to state their arguments before the Director or to rectify the deficiencies that are capable of being rectified, within a period of time as directed by the Director; however, if the Director considers that there is an urgent and immediate need to cancel or suspend the registration of an operator of a testing site or collection point, having been satisfied that there is a concern of a serious danger to public health, the Director may cancel or suspend the registration forthwith, by a reasoned decision, provided that the Director shall give the operator an opportunity to state their arguments as soon as possible after the cancellation or suspension, and no later than 14 days from the date of the decision.

Medical Management§

8.
(a)An operator of a corona testing site or collection point shall appoint a medical manager; such a medical manager shall be a medical laboratory worker.
(b)The areas of responsibility of the medical manager to be appointed shall be as follows:
(1)drafting appropriate procedures for the operation of the corona testing site and collection point and updating them, subject to the provisions of these Regulations;
(2)conducting tests and taking samples in accordance with the procedures referred to in paragraph (1) and in accordance with these Regulations;
(3)documenting and reporting on the conduct of tests and their results in accordance with these Regulations;
(4)routine maintenance of the medical equipment and installations at the testing site and the collection point, including storage of equipment and its routine upkeep;
(5)granting written authorisation for the taking of samples to samplers at the corona testing site or the collection point, in accordance with the provisions of regulation 11, provided that the medical manager is satisfied that they possess the qualifications, experience, detailed and documented training and competence required for conducting corona tests at an adequate standard;
(6)granting written authorisation to remote samplers pursuant to regulation 14b(a), provided that the medical manager is satisfied that they possess the qualifications, experience, detailed and documented training and competence required for performing remote supervision over a person being tested who is conducting a remotely supervised home self-test at an adequate standard.

Undertaking to Maintain Medical Confidentiality§

9.

The operator of the corona testing site or collection point shall obtain the signature of those subordinate to the operator, including employees of the testing site or collection point, on a confidentiality undertaking form for the preservation of the confidentiality of matters brought to their knowledge in the course of performing their role or in the course of their work; the Director shall publish a specimen of such a form on the website of the Ministry of Health.

Appointment of a Person in Charge§

10.
(a)At a corona testing site or collection point at which more than three stations at which sampling or testing operations are performed are in operation, or at a corona testing site at which blood-drawing operations are performed, the medical manager shall also appoint a person in charge at the site or station who shall be responsible for the management and operation of the site or station; the person in charge shall be appointed from among the samplers operating at the corona testing site or collection point; at a corona testing site at which blood-drawing sampling operations are performed, the person in charge shall be a medical laboratory worker; the person in charge shall be present at the testing site or collection point during the operation of the testing site or collection point for which that person is responsible.
(b)The areas of responsibility of the person in charge to be appointed shall be as follows:
(1)supervision and conduct of quality control of work processes at the corona testing site or collection point;
(2)supervision of the activity of the corona testing site or collection point in accordance with the procedures as referred to in these Regulations, including procedures established pursuant to regulation 8(b)(1);
(3)reporting to the medical manager on the activity of the corona testing site or collection point, including reporting on malfunctions discovered.

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Chapter III: Conducting a Test

Section A: Authorisation for a Sampler and a Remote Sampler

Sampling§
11.
(a)A person shall not take samples at a corona testing site or collection point operated by a person registered in the registry for the purpose of conducting corona tests, and shall not supervise the conduct of a remotely supervised home self-test, unless the medical manager of that site or point has given that person written authorisation to perform the operations of a sampler or remote sampler, as the case may be.
(b)Nothing in this regulation shall permit a person to perform an exceptional procedure, as defined in the Physicians (Competencies for Performing Exceptional Procedures) Regulations, 5761-2001, otherwise than in accordance with those Regulations.
(c)The Director shall publish recommended criteria for the qualifications, experience, training and competence required for conducting corona tests at an adequate standard and for conducting a remotely supervised home self-test, in accordance with which the medical manager shall act when granting written authorisation to perform the operations of a sampler pursuant to regulation 8(5) or (6).

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Section A-1: Sampling and Transportation

Instructions for Conducting Corona Tests§
12.

The taking of samples by a sampler who is not a remote sampler for the purpose of conducting tests, as well as the conduct of rapid corona tests by such a sampler, shall be carried out in accordance with the Third Schedule.

Packaging and Transportation of Samples§
13.

The packaging and transportation of samples from a collection point to a medical laboratory shall be carried out in accordance with the Fourth Schedule.

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