Owners or operators of diagnostic laboratories must get approval before providing non-approved tests or treatments, cannot charge fees for non-approved services, and must follow safety, standards, and reporting requirements.
Diagnostic Laboratories Regulation, M.R. 16/95 The Health Services Insurance Act , C.C.S.M. c. H35 Regulation 16/95 Registered February 9, 1995 bilingual version (HTML) Table of Contents Section 1 Definitions 2 No charges for services that are not approved 3 Application to provide new tests 4 X-ray safety requirements 5 College of Physicians and Surgeons requirements 5.1 Copies of reports or correspondence from the program review committee 6 When medical practitioner does not require approval 7 Repeal Definitions 1 In this regulation, "Act" means The Health Services Insurance Act ; («  Loi  ») "approved service" means a diagnostic test, examination or treatment that is specified in an approval for a diagnostic laboratory or for a branch or extension of a diagnostic laboratory under section 121 of the Act; (« service admissible ») "diagnostic laboratory" means a laboratory for which an approval has been granted under section 121 of the Act; (« laboratoire de diagnostic ») "program review committee" means the committee appointed by The College of Physicians and Surgeons of Manitoba under subsection 40(1) of The Medical Act which establishes and monitors compliance with standards for diagnostic laboratories. (« comité de contrôle des programmes ») M.R. 189/2008 No charges for services that are not approved 2 The owner or operator of a diagnostic laboratory shall not charge to, or collect from, an insured person or the minister any fee for a service performed by the laboratory for an insured person unless the service is an approved service. Application to provide new tests 3(1) An owner or operator of a diagnostic laboratory who proposes to provide a test, examination or treatment that is not an approved service shall apply to the minister for approval to provide the proposed test, examination or treatment. 3(2) An application under subsection (1) shall be made in writing in a form acceptable to the minister. 3(3) An owner or operator of a diagnostic laborabory shall not provide a proposed test, examination or treatment unless an approval has been granted. X-ray safety requirements 4 The owner or operator of a diagnostic laboratory shall comply with the X-Ray Safety Regulation under The Public Health Act . College of Physicians and Surgeons requirements 5 The owner or operator of a diagnostic laboratory shall operate the laboratory in compliance with the standards for diagnostic laboratories prescribed by The College of Physicians and Surgeons of Manitoba, as amended from time to time. Copies of reports or correspondence from the program review committee 5.1 The owner or operator of a diagnostic laboratory shall provide to the minister, or a person designated by the minister, a copy of each report or other related correspondence received from the program review committee, within seven days after receiving the report or correspondence. M.R. 189/2008 When medical practitioner does not require approval 6 A medical practitioner does not require an approval under section 121 of the Act to perform in his or her office the laboratory procedures designated in Laboratory Procedures (Short List) of the Schedule to the Payments For Insured Medical Services Regulation if the College of Physicians and Surgeons of Manitoba has approved the medical practitioner to provide such laboratory procedures in the practitioner's office. Repeal 7 The Diagnostic Laboratories Regulation , Manitoba Regulation 94/86, is repealed.