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An empirical analysis of the legal frameworks governing genetic services labs in Canadian provinces.

Introduction

In Canada, the regulatory framework governing genetic tests is complex and is not systematically harmonized across the Canadian provinces or between different legal jurisdictions. For example, when genetic tests are sold as diagnostic in vitro kits, they primarily fall under the purview of the Health Canada pre-market launch requirements regarding their safety and effectiveness. By contrast, when such tests are offered as a service in a laboratory setting they do not fall under federal jurisdiction, but rather provincial jurisdiction. The proliferation of genetic tests available to the public as well as the importance of the information they contain about the life and health of patients, especially when they are of the presymptomatic or predictive kind, warrant a systematic enquiry into similarities and differences in the regulatory environment surrounding lab-based genetic test services in Canadian provinces. Is a governmental operating license always necessary? Is the peer-delivered accreditation process similar? An empirical study of the regulatory themes put forward by the provinces would allow for a greater understanding of the legal frameworks governing genetic test services offered in Canadian labs. This information is also essential to lay the groundwork for future regulatory harmonization of genetic tests across the Canadian provinces as well as internationally between Canada and other countries. Using qualitative research and document analysis methods, we herein present the results of an empirical thematic study of the regulatory measures over genetic test services in Canadian provinces.

Materials and Methods

In order to identify and compare the legal frameworks governing genetic services labs across Canadian provinces, we undertook a systematic empirical study for each province of the legal documents, both statutes and regulations, retrieved from the Canadian legal electronic database Canadian Legal Information Institute (CanLII) and the published literature obtained from a search of the Pubmed and Index to Canadian Legal Literature (LawSource) databases. The Canadian territories were not included in the present analysis. Selective keywords were used for the literature searches: 'laboratory', 'genetics', 'diagnostic facility', 'accreditation', 'quality', 'hospital', 'health' and 'license'. Only provisions at the provincial level and not lower jurisdictions, such as regional health authorities, were searched. The documents were then organized by jurisdiction and themes. For completeness, we consulted numerous websites including the College of Physicians and Surgeons website for each province and the Canadian Council on Health Services Accreditation (CCHSA) website. When necessary, some of these institutions were contacted by e-mail to obtain further detailed information. All documents were analyzed for their contents independently by each investigator and coded for accuracy. After independent content analysis, investigators conferred to reach a consensus on identified themes and regulatory frameworks.

Results

We identified six emergent themes pertinent to regulation of genetic tests in Canada.

1. A Fragmented Legal Framework Between the Federal and Provincial Jurisdictions

The Canadian regulatory framework governing genetic tests is fragmented as a result of the constitutional division of powers between the federal and provincial levels of government. This institutional arrangement gives rise to two categories of genetic tests control, depending upon the jurisdiction.

First, genetic tests marketed as in vitro diagnostic devices are mostly subject to federal control by virtue of its authority in criminal matters. The Medical Devices Regulations (1), under the Food and Drugs Act (2), covers genetic tests and provides a series of measures meant to assess their safety, as well as their effectiveness, prior to their commercialization. Aside from the basic requirements that medical device manufacturers must meet (e.g. obligation of identifying the inherent risks associated with a device and either eliminating these or reducing them, the requirement that the product performs as intended, etc.) (3), categorizing genetic tests as Class III devices (corresponding to a high individual health risk or a moderate collective health risk) requires that a license be issued by the Medical Devices Bureau of Health Canada's Therapeutic Products Directorate. (4) To obtain this license, the genetic test manufacturer must provide a summary of all studies relied upon to ensure that the device meets safety and effectiveness requirements. In addition, a summary of investigational testing conducted on the device using human subjects representative of the intended users (and under conditions similar to the conditions of use), as well as a copy of the certificate on quality management system certifying that the system under which the device is designed and manufactured satisfies the National Standard of Canada CAN/CSA-ISO 13485:03, entitled Medical devices--Quality management systems--Requirements for regulatory purposes must be provided. (5) All Class III and IV medical devices must undergo a scientific and medical review of submitted evidence of safety and effectiveness before their licence applications can be finalized. (6)

Second, when the tests are offered as a service by a laboratory they are outside the scope of the Medical Devices Regulations and fall under the provincial jurisdiction. (7) The Constitution Act of 1867 accords legislative powers relating to property and civil rights to the provinces, including services offered within a province. (8) Echoing the framework existing in countries such as Australia, France and the US (9), three main elements are recurrent, but are not always combined when it comes to regulating genetic services labs in Canadian provinces. As we shall present in more detail below, they include the requirement: (1) to hold a government-issued license, (2) to obtain a peer-delivered accreditation, and (3) the presence of established internal and external quality controls. (10)

2. What Role Does the Law Play in the Regulation of Genetic Services Labs?

It is interesting to note that there is no specific law regulating labs offering genetic test services in any of the ten Canadian provinces. It seems as if provinces have avoided drawing a clear distinction between genetic tests and other medical tests. Thus, genetic tests fall under the general provisions that regulate medical labs in each province.

Opting for the law as an instrument with which to regulate medical labs is not the rule. Only six provinces have preferred this normative strategy, with varying degrees of interventionism. While Quebec, Ontario and Saskatchewan each have enacted a specific law to regulate medical labs (11), Newfoundland has integrated a provision including labs into its regulations made under its Public Health Act. (12) British Columbia and Manitoba have preferred to regulate labs through the coverage of diagnostic tests provided by their provincial health insurance plan. (13) This distinction is important: while the standards in the first two categories apply to all labs covered by the law or regulations, in the third only those labs wanting publicly funded coverage for the diagnostic tests they offer are submitted to the provincial legal requirements. It would be erroneous to conclude, however, that there exists a regulatory vacuum in the provinces having eschewed the legislative model. We shall see below that the self-regulation strategy is very widely accepted.

3. The Obligation for Labs to Obtain a Government-issued License

In provinces where legislative strategies are preferred, labs must obtain an operating license from the provincial Minister of Health. The issuance of such a permit is thus a necessary first step. However, this obligation is not uniformly applied to all laboratories in a province. In fact, Quebec and Newfoundland only impose this prerequisite on private labs. (14) Ontario, British Columbia, Manitoba, and Saskatchewan do not draw such a private/public distinction. While no relevant statutory obligation exists in New-Brunswick, the Hospital Services Branch of the Department of Health and Wellness is responsible for approving new hospital services. Thus, one could understand that departmental approval would need to be obtained for a new hospital lab service. (15) Among the categories of licenses issued, only two provinces have specifically considered genetic tests. Indeed, Ontario has created a "cytogenetic" category (16), while Saskatchewan limits the provision of cytogenetic test to labs holding a category 6 license (the one allowing the widest variety of medical tests). (17) Although, it is noteworthy that most provinces issue an operating license with a list of tests each lab is authorized to run.

Few laws mention the duration of the licenses. In Quebec and Ontario, an annual renewal of the license is necessary (18), implying the recurrent fulfillment of administrative formalities. Alternatively, Saskatchewan issues a license for a maximum duration of three years. (19) The motivation behind requiring labs to obtain a license lies in the government's ability to exercise control over the dispensing of medical services in the province. Aside from safety and professional qualification requirements, that will be elaborated further in the paper, the issuance of a license is linked to the needs of a given population, the geographic distribution of labs and the capacity of existing ones to actually dispense the proposed tests. The proper management of provincial resources thus represents a key component of processing licensing requests.

4. The Accreditation Requirement

Unlike the license issued by public authorities, an accreditation is the official recognition, by a governing body, of a competent laboratory. An external assessment procedure is carried out by independent professionals who examine every aspect of a lab's operations and practices. Accreditation is meant to ensure the safety and the quality of tests while promoting a culture of continuous quality improvement within labs. This self-regulation mechanism is the most widely used for labs in Canada. It can either be established as a condition to the issuance of a government-operating license (20), or more generally, as a requirement by provincial medical laws. (21) All provinces require this specific lab accreditation mechanism except for the four Atlantic provinces. The latter have a joint accreditation program, the Atlantic Provinces Medical Peer Review Program that assesses the practices of physicians but not those of laboratories. (22) Beyond these provincial mandatory accreditation requirements for laboratories, labs can participate in other accreditation programs or be assessed as a component of the entire health care organization accreditation program (e.g. the one offered by CCHSA).

The strength of this mechanism lies mostly in that it is applied, in almost all provinces, by self-regulated local bodies representing the medical profession. In Alberta, British Columbia, Manitoba, and Saskatchewan it is the College of Physicians and Surgeons within each province that is responsible for accrediting labs. However in Ontario, it is the Ontario Medical Association that is responsible. (23) The accreditation process generally falls under a specific program within relevant bodies. (24) Ontario (25) and British Columbia (26) have, in addition, established a specific division regarding genetics in theirs.

Accreditation is generally mandatory for all labs, regardless of their private or public status, the same governing body being responsible for both. However, Quebec makes such a distinction. Section 107.1 of the Act Respecting Health Services and Social Services (27) stipulates that every three years public laboratories must have the health services and social services they provide accredited by a recognized accreditation body. However, the section does not refer to a specific accreditation body. The assessment of public labs is integrated into the general accreditation process for health care institutions. (28) The Circular 2005-007 released by the Minister of Health defines a recognized accreditation body as an independent, not-for-profit organization, that has obtained national and international recognition in the health care field. (29) Two accreditation bodies share this task, the CCHSA and the Conseil quebecois d'agrement (CQA). The choice of which to use is left to the discretion of each institution. (30) Notably, the private sector has no mention of such an accreditation requirement within the Act Respecting Medical Laboratories. Thus, for the moment, Quebec's private labs are not required to obtain any accreditation. An upcoming revision of this act should correct this loophole. (31)

The duration of the accreditation is usually longer than that of a license. In Ontario, British Columbia, Manitoba and Saskatchewan, an accreditation lasts for a maximum of five years (32), four in Alberta. (33)

Certain accreditation bodies have elaborated specific categories for labs offering genetic tests. In British Columbia, an "Anatomic Pathology and Cytogenetic Facility" category was created. (34) In Alberta, labs willing to perform genetic tests, whether they be biochemical, cytogenetic or molecular, must obtain one of two following classifications: Major Laboratory (labs allowed to perform all laboratory pathology tests) or Specialized Laboratory (in case of labs specialized exclusively in genetic testing). (35) Likewise in Manitoba, only a Major Laboratory can offer genetic tests. (36)

In general, while the lab accreditation process differs between provinces, they take similar elements into consideration. Overall, they aim to exercise quality control over a lab's equipment, technical operating conditions and safety, as well as the proficiency of its personnel. The process is closely linked to the internal and external quality control procedures to which a lab is submitted. Different assessment techniques that typically consist of a self-assessment and an on-site inspection are usually combined. While procedures and aims are shared, reference standards for lab accreditation are specific to each province even if they are all inspired by the ISO 15189 standard and its Canadian version CAN/CSA Z15189-03. (37) Unfortunately, there is no harmonization of the applicable reference standards.

5. Personnel Qualification

The legal provisions concerning personnel qualification are more varied. There is, however, a noticeable trend favouring physicians as lab directors and, more specifically, the ones who are specialists in a branch of laboratory medicine. Some provinces explicitly mention the opportunity of a specialization in genetics (Manitoba, Saskatchewan and Alberta). (38) Quebec (private sector), Ontario and Manitoba are open to directors that are experienced clinical scientists. (39) The director is responsible for the supervision of routine laboratory procedures, as well as the establishment and compliance with standards and quality control procedures. Quebec has adopted a rather surprising position in that the statutory qualification requirements for the public sector are, at least on paper, less stringent than those for the private sector. The only relevant passage stipulates that any clinical department formed in a hospital centre must be directed by a physician, a dentist or a pharmacist. (40) However, in a short-term care hospital centre, a clinical department of medical biological laboratories has to be set up and headed by a medical specialist. (41)

Moreover, most provinces require the presence of medical laboratory technologists among the laboratory staff. (42) For these technologists, clinical genetics training programs accredited by the Conjoint Committee for Accreditation of Educational Programs in Medical Laboratory Technology are available in Ontario and British Columbia. (43) Quebec requires that at least one out of three technical staff members working in a private lab is a medical laboratory technologist. (44)

6. Quality Control in Labs

The establishment of a quality assurance program aims to guarantee the best possible quality of the data produced by a lab. This means the data are entirely reliable and suitable for the purpose for which they are destined. Internal and external quality controls are the cornerstone of the licensing and accreditation processes in Canadian provinces. They are legally mandatory in all provinces. (45)

Internal quality control must generally be established by laboratory directors. Labs offering genetic tests cannot avoid this and are required to establish procedures in order to control the quality of the tests rendered. These procedures have to be clearly defined and directors have the responsibility to assess all quality control data and evaluate their lab's performance. Tolerance limits must be defined, and corrective actions must be taken when necessary. These are some of the measures that constitute good laboratory practices and maintain an ongoing quality control within laboratories.

External quality control is an independent and external assessment of the accuracy of regular results that allows for an impartial review of the quality of a lab's analyses. These performance evaluations are designed to assess the precision of the results produced by the lab when performing different tests, and not only to ensure that any inaccurate result be flagged. It also promotes the standardization of lab practices. In the Canadian provinces, external quality controls programs are usually managed by the same body responsible for lab accreditation. (46) To our knowledge, only Ontario has an external quality control program specific to cytogenetics and molecular diagnostics of inherited diseases. (47) Other provinces generally require laboratories performing genetic tests to turn to specialized external quality control programs of their choice (48), such as the one offered by the College of American Pathologists or the program set up in Ontario.

Discussion

The legal frameworks surrounding genetic services labs differ between provinces. On one hand, there is a lack of binding rules in the three Maritime provinces (Prince Edward Island, Nova Scotia and New Brunswick), while on the other hand, Ontario, Manitoba, Saskatchewan, Alberta and British Columbia have very elaborated ones. Importantly, no province has wanted to separate the legal framework surrounding the offer of genetic tests from other biological tests. A functional approach as opposed to one based on "genetic specificity" was ultimately adopted. Genetic tests thus fall under the purview of the general provisions that deal with medical lab practices in each province, with the occasional minor specific adaptations made for genetics.

Provinces have based their normative strategy on genetic test services largely on self-regulation by means of lab accreditation programs, most of which are managed by the College of Physicians and Surgeons in each province. Whether accompanied by a governmental operating license or not, many procedures and aims are shared among the provinces regarding the use of standard operating procedures, external performance evaluations and staff qualifications which collectively allow an assessment of the quality of the work performed by the labs, as well as the reliability of the scientific tests they offer. However, the thresholds for reference standards in these aims and procedures across the Canadian provinces differ from each other without harmonization. Moreover, this functional strategy adopted by each province is not the equivalent to the kind of control exercised by the federal government of Canada. While genetic tests are directly targeted by federal regulations, provincial mechanisms aim to ensure the reliability and proper functioning of the labs, rather than the tests per se. The importance of the information that genetic tests can reveal would certainly justify setting up, at the interprovincial level, a formal assessment mechanism of genetic tests prior to their first clinical use in provincial labs. (49) Insofar as the governance of laboratories offering genetic test services is concerned, it would be advisable to appoint directors familiar with the interdisciplinary scope of information provided by genetic tests. As the emphasis in medicine and biosciences increasingly shift towards treatment of future disease liabilities instead of existing disease symptoms, genetic tests impact not only patients but also presently healthy populations with marked socio-ethical implications. This may require amendments to the organizational structure of labs offering genetic test services by appointing staff who are cognizant of both social and biomedical dimensions of genetic testing services.

Elodie Petit, is an Ethics Consultant; Anne Marie Tasse, is a Research Associate for the Bioethics Programs at the University of Montreal. Beatrice Godard is an Associate Professor and Director Bioethics Programs, Department of Preventative and Social Medicine, Faculty of Medicine, University of Montreal, Montreal, Quebec. Correspondence: Beatrice Godard, PhD, Associate Professor and Director, Bioethics Programs, Department of Preventive and Social Medicine, Faculty of Medicine, University of Montreal, C.P. 6128, succ. centre-ville, Montreal, Quebec. Email: beatrice.godard@umontreal.ca

Acknowledgements

The authors are indebted to the CanGeneTest members for their advices. CanGeneTest is a multidisciplinary consortium of 17 scientists, 21 collaborators and 5 national and international partner organizations funded by: Canadian Genetic Disease Network; CIHR, Genetics and Health Services and Policy Research; Canadian Coordinating Office on Health Technology Assessment; and Heart and Stroke Foundation. This research was supported by operating grants to Beatrice Godard from the Canadian Institutes of Health Research.

1. Medical Devices Regulations, S.O.R./98-282.

2. Food and Drugs Act, R.S.C. 1985, c. F-27.

3. Medical Devices Regulations, supra note 1 at ss. 10-20.

4. Ibid. s. 26

5. Ibid. s. 32(3). Quoted in M. Deschenes, Reflexion sur L'encadrement Normatif de la Mise en Marche des Tests Genetiques (Montreal: Themis, 2005) at 65.

6. Health Canada, Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications (Guidance document) (Ottawa: Health Canada, 1998), online: Health Canada <http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/prmkt2_precomm2_e.pdf> at 4. Deschenes, ibid.

7. Deschenes, ibid. at 75.

8. Constitution Act, 1867 (U.K.), 30 & 31 Vict., c. 3, reprinted in R.S.C. 1985, App. II, No. 5 at ss. 92 (7), 92 (13) and 92 (16). Deschenes, ibid. at 52.

9. This is the case for instance in the United States, Australia and France. For more details, see A.M. Tasse, E.P. Petit, B. Godard, "Comparative analysis of control structures for genetic laboratories in the United Kingdom, the United States, Australia and France" (2007) European Journal of Human Genetics 2007 (Submitted)

10. Ibid.

11. An Act respecting medical laboratories, organ, tissue, gamete and embryo conservation, and the disposal of human bodies, R.S.Q. c. L-0.2 [An Act respecting medical laboratories]; Laboratory and Specimen Collection Centre Licensing Act, R.S.O. 1990, c. L.1; Medical Laboratory Licensing Act, 1994, S.S. 1994, c. M-9.2.

12. Diagnostic and Public Health Laboratories Regulations, C.N.L.R. 789/96.

13. Medicare Protection Act R.S.B.C. 1996, c. 286 at s. 33(1); Health Services Insurance Act, C.C.S.M. c. H35 at s. 121(1).

14. An Act respecting medical laboratories, supra note 11 at s. 1(b); Diagnostic and Public Health Laboratories Regulations, supra note 12 at s. 3.

15. New-Brunswick, Hospital Services Branch of the Department of Health and Wellness, online: <http://www.gnb.ca/0051/0217/index-e.asp>.

16. Laboratories, R.R.O. 1990, Reg. 682 at s. 2.

17. Medical Laboratory Licensing Regulations, R.R.S. 1995, c. M-9.2 Reg. 1 at s. 5(f).

18. An Act respecting medical laboratories, supra note 11 at s. 37; Laboratory and Specimen Collection Centre Licensing Act, supra note 11 at s. 9(11).

19. Medical Laboratory Licensing Act, supra note 11 at s. 9(2).

20. It is the case in Manitoba's Diagnostic Laboratories Regulation, Man. Reg. 16/95 at s. 5, Saskatchewan's Medical Laboratory Licensing Act, supra note 11 at s. 8(b), and Ontario's Laboratory and Specimen Collection Centre Licensing Act, supra note 11 at s. 9 (14), as a component of the mandatory quality management program for labs.

21. Medical Profession Act, R.S.A. 2000, c. M-11 at s. 103, for private labs. The accreditation of public labs is covered by a contract concluded with Alberta Health & Wellness; Rules Made Under the Medical Practitioners Act, R.S.B.C. 1996, c. 285 at 121; The Medical Act, C.C.S.M. c. M90 at s. 40(2) and College of Physicians and Surgeons of Manitoba, By-Law 3a--Laboratory Facilities (Winnipeg: CPSM, 2002), online: CPSM <http://www.cpsm.mb.ca/1_3_1_bylaw_3a.php>.

22. See the Atlantic Provinces Medical Peer Review website at: <http://www.apmpr.ca/>.

23. Ontario Medical Association, Ontario Laboratory Accreditation (OLA) Program Information (Toronto: Ontario Laboratory Accreditation Division, 2006), online: OMA <http://www.qmpls.org/ola/Master%20-%20OLA%20Program%20Information%20Ontario.pdf> at 4.

24. Ontario Medical Association, Quality Management Program--Laboratory Services, Ontario Laboratory Accreditation; College of Physicians and Surgeons of Alberta, Medical Facility Assessment Committee and particularly, Advisory Committee on Laboratory Medicine; College of Physicians and Surgeons of British-Columbia, diagnostic accreditation program; College of Physicians and Surgeons of Manitoba, The Manitoba Quality Assurance Program; College of Physicians and Surgeons of Saskatchewan, Laboratory Quality Assurance Program.

25. Ontario Laboratory Accreditation, Scientific Committee: Genetics (Cytogenetics and Molecular Diagnostics of Inherited Diseases).

26. College of Physicians and Surgeons of BC, Diagnostic Accreditation Program, Anatomic Pathology and Cytogenetics Division.

27. An Act respecting Health services and social services, R.S.Q. c. S-4.2.

28. Minstere de la Sante et des Services Sociaux, Conformite des laboratoires de biologie medicale a la norme CAN/CSA-15189 "Laboratoire d'analyses de biologie medicale--Exigences particulieres concernant la qualite et la competence", Circulaire numero 2005-007 (Quebec: Minstere de la Sante et des Services Sociaux, 2005).

29. Ibid.

30. Information confirmed by the Quebec Ministry of Health and Social Services.

31. Ibid.

32. Ontario Medical Association, supra note 23 at 13; Rules Made Under the Medical Practitioners Act, supra note 21 at s. 125(f); By-Law 3a--Laboratory Facilities, supra note 21 at s. 2.8(b); College of Physicians and Surgeons of Saskatchewan, Laboratory Quality Assurance Program, online: CPSS <http://www.quadrant.net/cpss/guide/lqapc.html>.

33. See College of Physicians and Surgeons of Alberta, Major Laboratory--Standards and Guidelines (Edmonton: CPSA, 2005), online: CPSA <http://www.cpsa.ab.ca/facilitiesaccreditation/attachments/Standards_Major%20Laboratory.pdf> at s. 2.1.14.

34. Rules Made Under the Medical Practitioners Act, supra note 21 at s. 119(vi).

35. Major Laboratory--Standards and Guidelines, supra note 35; College of Physicians and Surgeons of Alberta, Laboratory Classifications (Edmonton: CPSA, 2004), online: CPSA <http://www.cpsa.ab.ca/facilitiesaccreditation/attachments/Laboratory%20Classifications.doc>.

36. Information obtained from the-College of Physicians and Surgeons of Manitoba.

37. For the sake of illustration, see, in Ontario, Ontario Medical Association, Accreditation Process--Accreditation Requirements and Guidance Information, online: OMA <http://www.qmpls.org/ola/ola_process3.html> and in Quebec, Minstere de la Sante et des Services Sociaux, supra note 28. For the other provinces information is confirmed by the relevant accreditation bodies.

38. By-Law 3a--Laboratory Facilities, supra note 21 at s. 4.3(a); Medical Laboratory Licensing Regulations, supra note 17 at s. 2(1)(d); Major Laboratory--Standards and Guidelines, supra note 35 at 80.

39. Regulation respecting the application of the Public Health Protection Act, R.Q. c. L-0.2, r.l at s. 132; Laboratories, supra note 16 at s. 6(1); By-Law 3a--Laboratory Facilities, supra note 21 at s. 6.1.

40. An Act respecting health services and social services, supra note 27 at s. 188. With the exception of clinical biochemistry departments, which can be headed by a clinical biochemist.

41. Organization and Management of Institutions Regulation, R.Q. c. S-5, r.3.01 at ss. 70, 72. When a biochemistry or a microbiology department is set up, its director can be either a physician or a professional with a diploma in one of the fields of medical biology, at s. 70.

42. Regulation respecting the application of the Public Health Protection Act, supra note 39 at s. 133; Laboratories, supra note 16 at s. 6(3); College of the Physicians and Surgeons of Alberta, Bylaws of the College of Physicians and Surgeons of Alberta--Part B (Edmonton: CPSA, 2006) at 92(1); Bylaw 3a--Laboratory Facilities, supra note 21 at s. 5.2; Medical Laboratory Licensing Regulations, supra note 8 at s. 9.

43. Canadian Society for Medical Laboratory Science, Training Programs, online: CSMLS <http://www.csmls.org/english/career/programs.htm>.

44. Regulation respecting the application of the Public Health Protection Act, supra note 39 at s. 133.

45. Internal Quality Control: Regulation respecting the application of the Public Health Protection Act, supra note 39 at ss. 139, 140; Laboratory and Specimen Collection Centre Licensing Act, supra note 21 at s. 9 (14)(a); Bylaws of the College of Physicians and Surgeons of Alberta--Part B, supra note 42 at 73 (1)(d); Rules Made Under the Medical Practitioners Act, supra note 21 at ss. 126, 128; Medical and Health Care Services Regulation, B.C. Reg. 426/97 at s. 39(1)(i); Bylaw 3a--Laboratory Facilities, supra note 21 at s. 8.1(a); Medical Laboratory Licensing Regulations, supra note 17 at s. 3 (2)(f). External Quality Control: For private laboratories, Regulation respecting the application of the Public Health Protection Act, supra note 39 at s. 140.1; Laboratory and Specimen Collection Centre Licensing Act, supra note 11 at s. 9(14)(b); Bylaws of the College of Physicians and Surgeons of Alberta--Part B, supra note 42 at 73(1)(i); Rules Made Under the Medical Practitioners Act, supra note 21 at s. 128; Medical and Health Care Services Regulation, B.C. Reg. 426/97 at s. 39(1)(i); Bylaw 3a--Laboratory Facilities, supra note 21 at s. 8.1(b); Medical Laboratory Licensing Regulations, supra note 17 s. 3 (2)(g). Note: in the four Atlantic provinces, we have not come across relevant legal information in the provincial legislatures

46. Ontario Medical Association, Quality Management Program--Laboratory Services, External Quality Assessment; College of Physicians and Surgeons of Alberta, Alberta Laboratory Quality Enhancement Program; College of Physicians and Surgeons of British-Columbia, Diagnostic Accreditation Program; College of Physicians and Surgeons of Manitoba, The Manitoba Quality Assurance Program; College of Physicians and Surgeons of Saskatchewan, Laboratory Quality Assurance Program. External quality control in private Quebec labs is administered by the Laboratoire de sante publique du Quebec. See the Regulation respecting the application of the Public Health Protection Act, supra note 39 at s. 140.1.

47. Ontario Medical Association, Quality Management Program--Laboratory Services External Quality Assessment, Genetics (Toronto: OMA, 2006), online: OMA <http://www.qmpls.org/eqa/eqa_gene.html>.

48. Information obtained from officials in charge of external assurance programs for labs in various provinces. Quebec's Public Health Laboratory, however, requires the use of the quality assurance program set up by the College of American Pathologists.

49. I. Blancquaert et al., "Oversight Mechanisms for Technology Transfer in Molecular Genetics--Meeting the Challenge" (2001) 2:3 Isuma, online: Isuma <http://www.isuma.net/v02n03/blancquaert/blancquaerte.shtml>.
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Author:Petit, Elodie; Tasse, Anne Marie; Godard, Beatrice
Publication:Health Law Review
Date:Jun 22, 2008
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