R.R.O. 1990, Reg. 683: SPECIMEN COLLECTION CENTRES

Laboratory and Specimen Collection Centre Licensing Act

R.R.O. 1990, REGULATION 683

SPECIMEN COLLECTION CENTRES

Historical version for the period March 20, 2014 to June 18, 2015.

Last amendment: O. Reg. 66/14.

This is the English version of a bilingual regulation.

1. (1) An application for a licence or a provisional licence to establish, operate or maintain a specimen collection centre or renewal thereof shall be submitted to the Director.  R.R.O. 1990, Reg. 683, s. 1 (1).

(2) A licence, provisional licence or renewal thereof to establish, operate or maintain a specimen collection centre shall be in the form provided by the Ministry.  R.R.O. 1990, Reg. 683, s. 1 (2); O. Reg. 449/98, s. 1 (1).

(3) The fee for the issuance or renewal of a licence is $572.  O. Reg. 359/02, s. 1.

(4) The fee for the issuance or renewal of a provisional licence is $286.  O. Reg. 359/02, s. 1.

(5) The owner of every licensed specimen collection centre shall ensure that the licence is posted in a conspicuous place in the specimen collection centre.  R.R.O. 1990, Reg. 683, s. 1 (5); O. Reg. 449/98, s. 1 (2).

(6) Revoked: O. Reg. 14/14, s. 1.

2. An applicant for a licence to establish, operate or maintain a specimen collection centre shall have,

(a) staff who are certified in the manner required in section 3 as qualified to take and collect specimens from the human body; and

(b) the equipment and furnishings specified in section 4.  R.R.O. 1990, Reg. 683, s. 2.

3. No person shall be employed by the owner or operator of a specimen collection centre for the purpose of taking or collecting specimens from the human body unless a legally qualified medical practitioner has certified in writing to the owner or operator, as the case may be, of the centre that the person has,

(a) competence in the techniques of taking and collecting specimens from the human body;

(b) the ability to manage and care for patients; and

(c) a high standard of personal cleanliness.  R.R.O. 1990, Reg. 683, s. 3; O. Reg. 796/93, s. 1; O. Reg. 14/14, s. 2.

4. (1) Every owner and operator of a specimen collection centre shall ensure that the centre has,

(a) a chair to accommodate patients for the purpose of taking blood specimens;

(b) a couch or other furnishing to accommodate patients in case of illness;

(c) a refrigerator;

(d) a centrifuge;

(e) clean storage space for storing supplies and instruments;

(f) at least one clean and covered container for skin cleansing swabs;

(g) a self-closing waste disposal container;

(h) a waiting room for patients;

(i) a private room for taking specimens; and

(j) toilet and washroom facilities for patients.  R.R.O. 1990, Reg. 683, s. 4 (1).

(2) Every owner and operator of a specimen collection centre shall ensure that a record is kept indicating,

(a) the names of the patients attending the centre;

(b) the names of any of the following persons who requested the taking and collecting of specimens:

(i) a legally qualified medical practitioner,

(ii) a dentist,

(iii) a midwife,

(iv) a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991;

(c) the specimen or specimens taken and collected from each patient;

(d) the date and time of submission of the specimens to a licensed laboratory; and

(e) the name and address of the laboratory to which the specimens are sent.  R.R.O. 1990, Reg. 683, s. 4 (2); O. Reg. 796/93, s. 2; O. Reg. 47/98, s. 1.

5. Every licence that is issued to establish and operate or maintain a specimen collection centre is subject to the conditions that,

(a) the person or persons named in the licence as owner or owners of the centre are in fact the owner or owners of the centre and are also the owner or owners of a laboratory licensed under the Act;

(b) the centre maintains staff certified under section 3 to take and collect specimens from patients;

(c) the centre remains at the address shown on its licence;

(d) specimens are taken or collected from a patient only at the request of a legally qualified medical practitioner, a dentist, a midwife or a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991;

(e) the specimens taken or collected from a patient are submitted only to a laboratory licensed under the Act or to a laboratory operated by the Ministry of Health or of the Crown in right of Ontario;

(f) no laboratory tests, other than fasting urine glucose dipstick tests performed in relation to glucose tolerance tests that are to be performed in a laboratory, are carried out in the centre;

(g) no payment or consideration of any kind is provided or offered to any donor of blood or blood constituents in return for the donation, whether directly or indirectly; and

(h) no compensation for any expenditure of any kind or for time, travel or commitment is made to any donor of blood or blood constituents, whether directly or indirectly. R.R.O. 1990, Reg. 683, s. 5; O. Reg. 796/93, s. 3; O. Reg. 47/98, s. 2; O. Reg. 449/98, s. 2; O. Reg. 14/14, s. 3; O. Reg. 66/14, s. 1.

6. No person other than the owner of a laboratory licensed under the Act shall have any proprietory interest in a specimen collection centre.  R.R.O. 1990, Reg. 683, s. 6; O. Reg. 14/14, s. 4.

7. (1) In this section,

“temporary specimen collection centre” means a specimen collection centre that is established, operated or maintained at a temporary, mobile or portable location. O. Reg. 14/14, s. 5.

(2) Despite subsection 9 (3) of the Act, a licence is not required to establish, operate or maintain a temporary specimen collection centre if it is established, operated or maintained by the owner and operator of a specimen collection centre that is licensed under the Act. O. Reg. 14/14, s. 5.

(3) Where subsection (2) applies, any conditions or restrictions to which the specimen collection centre’s licence is subject apply with necessary modifications with respect to the temporary specimen collection centre. O. Reg. 14/14, s. 5.

(4) Every owner and operator of a temporary specimen collection centre to which subsection (2) applies shall ensure that no specimen taking or collecting is carried out in the centre other than specimen taking or collecting authorized by the specimen collection centre’s licence, and no person employed in the temporary specimen collection centre shall knowingly participate in such specimen taking or collecting. O. Reg. 14/14, s. 5.

(5) Subsection 4 (1) does not apply with respect to a temporary specimen collection centre to which subsection (2) applies, but every owner and operator of such a centre shall ensure that the centre has the equipment and furnishings necessary to ensure the integrity of the specimens and the safety and privacy of patients, taking into consideration the list of items set out in that subsection. O. Reg. 14/14, s. 5.

Form 1 Revoked:  O. Reg. 449/98, s. 3.