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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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Despite these checks, it may contain errors, omissions, or imprecise renderings of legal terminology and cross-references, and it may not yet reflect the latest amendments. It cannot be relied upon as a legal text.

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.

This translation is provided for informational purposes only and does not constitute legal advice. For use in legal proceedings, request a certified Expert Legal Opinion.

Section B: Conducting a Rapid Corona Test

Medical Equipment for Conducting a Corona Test§
14.

An operator of a corona testing site or collection point registered in the registry shall not conduct sampling or a corona test except by means of medical equipment designated for that test which the Director has permitted to be used and in accordance with the conditions that the Director has instructed in writing in that regard; for the purposes of this regulation, "medical equipment" – as defined in the Medical Equipment Law, 5772-2012.

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Section C: Remotely Supervised Home Self-Test

Definition§
14a.

In this Section, "operator" – an operator of a corona testing site through which remote supervision of a remotely supervised home self-test is conducted, or an operator of a collection point for a remotely supervised home self-test.

Provisions for Remote Sampling§
14b.
(a)A remote sampler shall identify the person being tested by means of facial identification against an identity card, driving licence, travel document or passport, and if the person being tested is a minor – identification may also be carried out by means of identifying the minor's identity number in the annex to the identity card of the parent and facial identification of the parent against the identity card.
(b)A remote sampler shall identify the test kit, shall verify that the test is conducted using that same kit, and if the test is a rapid corona test shall also verify that the photograph of the test result is of the same kit that was identified.
(c)A remote sampler shall supervise the conduct of sampling, and if the test is a rapid corona test also the conduct of the test; such supervision shall be by means of communication enabling the real-time transmission of image and sound between a remote sampler and the person being tested.
Provisions for Photography and Documentation of a Remotely Supervised Home Self-Test§
14c.

An operator or remote sampler shall not activate photography pursuant to this Section unless all of the following conditions have been met:

(1)the photography shall serve for the identification of the person being tested and the test kit and for remote supervision of the conduct of the sampling and the test, and for that purpose only;
(2)only the person being tested or a person on their behalf shall activate the photography;
(3)the photography shall not be recorded or saved; notwithstanding the foregoing in this paragraph, if the test is a rapid corona test, the operator is entitled to save the image of the test kit displaying the test result, which the person being tested shall send separately to the operator in accordance with the operator's request;
(4)no use shall be made during or after the photography of any biometric identification means or biometric identification data, as defined in the Law for the Inclusion of Biometric Identification Means and Biometric Identification Data in Identification Documents and a Database, 5770-2009, and no such data or means shall be derived from the photography.
Provisions for a Remote Sampler regarding Photography and Documentation of a Remotely Supervised Home Self-Test§
14d.

A remote sampler shall not conduct photography pursuant to this Section unless all of the following conditions have been met:

(1)the remote sampler shall notify the person being tested of the possibility of preparing for photography before it commences, and of the times and duration during which the person is required to activate visual or audio documentation;
(2)the photography shall continue only during the identification of the person being tested and the conduct of the test.

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Chapter IV: Miscellaneous

Duty to Report§

15.
(a)An operator of a testing site shall report to the Ministry of Health on the result of a test conducted by the operator, as soon as possible after the time of conducting the test as aforesaid, by means of a dedicated interface to be made available by the Ministry of Health; notwithstanding the foregoing, such an operator may report to the Ministry of Health by another means, if the operator has received a direct instruction or approval to do so from the Ministry of Health.
(b)Where a rapid corona test conducted at a corona testing site yields a positive result for the presence of the coronavirus – the operator shall provide the person being tested, in writing, with information on the obligation to enter isolation and to report thereon to the Ministry of Health pursuant to the Public Health Order (Novel Coronavirus) (Home Isolation and Miscellaneous Provisions) (Temporary Provision), 5780-2020, as well as on the possibility of ending or shortening the isolation period as referred to in that Order; the provision of information as referred to in this sub-regulation may also be by digital means.

Provision of Documents§

16.

The Director may require an operator of a corona testing site or an operator of a collection point to provide the Director, upon demand, with information, documents and data required for the purpose of supervising the conduct of rapid corona tests and for the purpose of protecting public health, including information regarding the location of a corona testing site or collection point and the number of tests conducted therein; in these Regulations, "document" – including a printout as defined in the Computers Law, 5755-1995.

Records of a Testing Site and Collection Point§

17.

The notebooks and records of a corona testing site or a collection point shall have the same status as a medical record for the purposes of the Patient Rights Law, 5756-1996, and any other law.

Transitional Provision§

18.

A person who, on the eve of the commencement of these Regulations, conducted a test at a corona testing site or a collection point may continue to conduct tests as aforesaid for an additional period of 14 days from the day of commencement of these Regulations, even without complying with the provisions of these Regulations.

Savings Provisions§

19.

Nothing in these Regulations shall derogate from the provisions of the Public Health (Treatment of Waste in Medical Institutions) Regulations, 5757-1997, or from the laws of privacy and information security.

Report to the Labour, Welfare and Health Committee of the Knesset§

20.

The Director shall submit to the Labour, Welfare and Health Committee of the Knesset, within 60 days of the day of commencement of these Regulations, and every two months thereafter, a report regarding the implementation of these Regulations, including regarding the operators of the corona testing site or collection points that have been registered, the number of tests conducted at each corona testing site or collection point, excluding serological tests, the quality of the tests, the samplers operating at corona testing sites or collection points, their training and experience, the geographical area of the corona testing sites and collection points, as well as a report on compliance with the provisions pursuant to regulations 12 and 14 of these Regulations.

Limitation of Application§

21.

These Regulations, with the exception of regulations 15 and 16 and Section C of Chapter III, shall not apply to a corona testing site or collection points operated by a hospital or a health fund, nor to a corona testing site or collection points operated by the State or on its behalf.

Operation of a Collection Point without a Sampler§

22.

Notwithstanding the provisions of regulations 11 and 12, an operator of a collection point may operate it without a sampler or by means of a remote sampler if authorised to do so by the Director and subject to the conditions of the authorisation; regulations 14b and 14c shall apply in respect of such a collection point.

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First Schedule (regulations 4 and 5)

Part 1

Please mark the requested item in Part 1 and complete Part 2.

Applying to register as an operator (please select): a corona testing site or a collection point.

Table
First nameSurnameIdentity numberName of corporationCorporation numberAddressTelephoneMobile telephone

I, the undersigned, hereby declare as follows –

(1)I make this affidavit in order to support the application to be registered in the registry of operators of a corona testing site or operators of a collection point pursuant to regulation 4 of the Public Health (Corona Sampling and Testing) Regulations, 5781-2021 (hereinafter – the Regulations).
(2)I have read and understood the provisions of the Regulations.
(3)I confirm that the conditions for my registration as an operator of a corona testing site / operator of a collection point pursuant to regulation 3(c) of the Regulations are fulfilled, and I am aware that it is my duty to ensure that the requirements of the Regulations are met at the testing site or collection point that I operate.
(4)I declare and undertake that the taking of samples for the purpose of conducting corona tests and the conducting of corona tests at the testing site or collection point that I operate shall be carried out in accordance with the Regulations and in particular in accordance with the Third Schedule to the Regulations and, in the matter of a remotely supervised home self-test, in accordance with Section C of Chapter III.
(5)I declare and undertake that the packaging of samples and their transportation from the collection point that I operate shall be carried out in accordance with the Regulations and in particular in accordance with the Fourth Schedule to the Regulations.
(6)I have appointed a medical manager pursuant to regulation 8 of the Regulations and his/her name is _______; I am aware and understand that the medical manager at the testing site or collection point shall be a medical laboratory worker, as defined in the Regulations.
(6a)If I operate a testing site or collection point comprising more than three sampling stations, or at a testing site or collection point at which blood-drawing operations are performed, I shall appoint a responsible person as required pursuant to regulation 10 who shall be present at the testing site or collection point during their hours of operation; I am aware and understand that the responsible person at the testing site at which blood-drawing is performed shall be a medical laboratory worker.
(7)I am aware and understand that it is prohibited to take samples for the purpose of conducting a corona test other than by a person who has received written authorisation from the medical manager to perform the operations of a sampler and subject to the provisions of the Physicians (Competence to Perform Exceptional Operations) Regulations, 5761-2001, and the provisions of any law.
(8)I undertake that rapid corona tests conducted at the corona testing site that I operate shall be carried out by means of medical equipment intended for rapid corona testing that the Director has permitted me to use for that purpose and subject to the conditions that the Director has instructed me regarding that medical equipment.
(9)I undertake to report to the Ministry of Health on the results of a test conducted at the corona testing site that I operate pursuant to regulation 15 of the Regulations.
(10)I undertake to take all necessary measures to ensure that all information and all reports that I transmit to the Ministry of Health pursuant to the Regulations, whether by myself or through my agents, shall be true, up to date, complete and accurate.
(11)I undertake to obtain the signature of every person subject to my authority at the corona testing site or collection point that I operate on an undertaking form for the preservation of medical confidentiality, pursuant to regulation 9 of the Regulations.
(12)I am aware and understand that the Director is entitled to cancel the registration of an operator of a corona testing site or a collection point, to make it conditional or to suspend it for a period that the Director shall determine upon the occurrence of one of the circumstances listed in regulation 7 of the Regulations, including if the registration was obtained on the basis of a false affidavit, including an affidavit containing misleading, incorrect or partial information.
(13)I am the authorised body on behalf of the corporation applying for registration to sign this affidavit. [Please delete this paragraph if the applicant is not a corporation]
Table
Signature of registration applicant _________________Date ____________

Confirmation

I, the undersigned, ________, advocate, hereby confirm that on ________ there appeared before me ________, who is personally known to me / whom I identified by identity card number _________, and after I cautioned him/her that he/she must tell the whole truth and nothing but the truth, and that he/she would be liable to the penalties prescribed by law if he/she failed to do so, he/she confirmed the correctness of the above declaration and signed it before me.

Table
Signature of affidavit confirmer ___________Date ____________

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Part 2

Please mark the requested item in Part 1 and complete Part 2.

Applying to renew registration as an operator (please select) of a corona testing site or a collection point.

Table
First nameSurnameIdentity numberName of corporationCorporation numberAddressTelephoneMobile telephone

I, the undersigned, hereby declare as follows –

(1)No changes have occurred in my affidavit given on ______ in support of the application to be registered in the registry of operators of a corona testing site / operators of a collection point pursuant to regulation 4 of the Public Health (Corona Sampling and Testing) Regulations, 5781-2021 (hereinafter – the Regulations), and I confirm that the conditions for the renewal of my registration as an operator of a corona testing site / operator of a collection point pursuant to regulation 3(c) of the Regulations are fulfilled.
(2)I am aware and understand that the Director is entitled to cancel the registration of an operator of a corona testing site or a collection point, to make it conditional or to suspend it for a period that the Director shall determine upon the occurrence of one of the circumstances listed in regulation 7 of the Regulations, including if the registration was obtained on the basis of a false affidavit, including an affidavit containing misleading, incorrect or partial information.

Confirmation

I, the undersigned, _______, advocate, hereby confirm that on _______ there appeared before me _______, who is personally known to me / whom I identified by identity card number __________ and after I cautioned him/her that he/she must tell the whole truth and nothing but the truth, and that he/she would be liable to the penalties prescribed by law if he/she failed to do so, he/she confirmed the correctness of the above declaration and signed it before me.

Table
Signature of registration applicant ________________Date _______________

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Second Schedule (regulation 4)

I, the undersigned, ________, identity number ________, (a copy of an identity card must be attached), hereby give my consent to the effect that the authorised body in the Ministry of Health, at any time and upon its request, shall be entitled to receive in respect of me information from the criminal record as defined in the Criminal Record and Rehabilitation Law, 5741-1981 (hereinafter – the Criminal Record Law), in the framework of my application to be registered in the registry of operators of a corona testing site / collection point pursuant to the Public Health (Corona Sampling and Testing) Regulations, 5781-2021; it is hereby clarified that this consent of mine also applies to the disclosure of criminal information to the said body from time to time for the purpose of carrying out periodic monitoring of changes that have occurred in the criminal information concerning me.

It has been clarified to me hereby that I am entitled pursuant to the Criminal Record Law to inspect at a police station the records maintained in my name in the criminal database, and that if I have a criminal record, I am entitled to attach information regarding my rehabilitation or personal circumstances, so that these may be taken into account when examining my application.

I am aware that this consent of mine is valid throughout the entire period of my tenure as a holder / as an office holder [please delete the inapplicable] in the holder of the registration or throughout the entire period of the registration in connection with which it was given, whichever is the earlier.

I am aware that by this consent I waive receipt of notice of the disclosure of the information, all subject to the provisions of the Criminal Record Law.

I, the undersigned, _______, identity number _________, (a copy of an identity card must be attached), hereby give on behalf of ________[full name of the corporation on whose behalf the consent is given] corporation number ________ my consent to the effect that the authorised body in the Ministry of Health, at any time and upon its request, shall be entitled to receive in respect of the said corporation information from the criminal record as defined in the Criminal Record and Rehabilitation Law, 5741-1981 (hereinafter – the Criminal Record Law), in the framework of the corporation's application to be registered in the registry of operators of a corona testing site / collection point pursuant to the Public Health (Corona Sampling and Testing) Regulations, 5781-2021; it is hereby clarified that this consent of mine also applies to the disclosure of criminal information to the said body from time to time for the purpose of carrying out periodic monitoring of changes that have occurred in the criminal information concerning me.

It has been clarified to me hereby that I am entitled pursuant to the Criminal Record Law to inspect at a police station the records maintained in the name of the corporation in the criminal database, and that if the corporation has a criminal record, I am entitled to attach information regarding its rehabilitation or circumstances, so that these may be taken into account when examining the application.

I am aware that by this consent I waive receipt of notice of the disclosure of the information, all subject to the provisions of the Criminal Record Law.

Table
Signature of registration applicant __________Date _______________

I, the undersigned, advocate ________ hereby confirm that according to the incorporation documents and decisions of the corporation _______ (name of corporation) number ________ (identification number of the corporation), Mr./Ms. ________ bearing identity card number _________ is authorised to undertake on behalf of the corporation in all matters relating to the application to be registered in the registry of operators of a corona testing site or a collection point pursuant to the Public Health (Corona Sampling and Testing) Regulations, 5781-2021.

Table
____________________________________________________
DateName and surnameLicence numberSignature and stamp

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