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Laboratory and Specimen Collection Centre Licensing Act

R.R.O. 1990, REGULATION 683

SPECIMEN COLLECTION CENTRES

Consolidation Period: From November 18, 2016 to the e-Laws currency date.

Last amendment: O. Reg. 362/16.

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) The owner of every licensed specimen collection centre shall ensure that the accreditation certificate issued by the agency that has been designated to carry out a quality management program is posted in a conspicuous place in the specimen collection centre. O. Reg. 362/16, 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,

(v) a member of the College of Naturopaths of Ontario;

(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; O. Reg. 170/15, 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,

(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, or

(v) a member of the College of Naturopaths of Ontario, for the purposes of performing a test set out in Appendix A;

(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 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;

(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;

(i) the operation of the centre meets the requirements of a quality management program; and

(j) the owner and the operator of the centre permit the agency that has been designated to carry out a quality management program to carry out such a program. 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; O. Reg. 170/15, s. 2; O. Reg. 362/16, s. 2.

6. No person other than the owner of a laboratory licensed under the Act shall have any proprietary 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.

8. A member of the College of Naturopaths of Ontario is exempt from sections 5 to 16 of the Act and from the provisions of this Regulation with respect to performing the following acts in the following places set out in paragraphs 1, 2 and 3:

1. Taking blood from his or her own patient in his or her own office for the purposes of performing one or more of the following naturopathic examinations in his or her own office:

i. Blood Group – ABO and RhD.

ii. BTA Bioterrain Assessment.

iii. Fatty acids, free.

iv. Glucose.

v. Hemoglobin – A1C.

vi. Live blood cell analysis.

vii. Mononuclear Heterophile Antibodies (monospot).

2. Taking or collecting specimens other than blood from his or her own patient in his or her own office for the purposes of performing one or more of the following tests in his or her own office:

i. Ascorbic acid (ascorbate) Vitamin C.

ii. BTA Bioterrain Assessment.

iii. Human Chorionic Gonadotropin – pregnancy test.

iv. Indican.

v. Koenisberg.

vi. Oxidative testing.

vii. Rapid Strep Test.

viii. Routine urinalysis by dipstick.

ix. Sulkowitch.

x. Vaginal pH.

3. Taking or collecting specimens other than blood from his or her own patient in his or her own office for the purposes of ordering one or more of the tests set out in Appendix B from a laboratory licensed under the Act. O. Reg. 170/15, s. 3.

APPENDIX A
Tests for which a Naturopath may Request Specimen Collection

Tests Performed on Blood

1. 17-OH-Progesterone.

2. 5α-dihydrotestosterone (DHT).

3. Adrenocorticotropic Hormone ACTH.

4. Alanine Transaminase (ALT, SGPT).

5. Albumin, qualitative.

6. Aldosterone.

7. Allergen Specific IgG Antibody.

8. Allergy testing (ELISA).

9. Allergy testing (IgE specific, RAST).

10. Alpha tocopherol – Vitamin E.

11. Amino Acids – Total Fractionation.

12. Ammonia.

13. Amylase.

14. Androstenedione.

15. Antibody Screening Food IgG.

16. Antibody Screening IgA.

17. Antibody Screening IgM.

18. Antigen Leukocyte Antibody.

19. Anti-Müllerian Hormone (AMH).

20. Anti-Nuclear Antibody.

21. Anti-Parietal Cell Antibody.

22. Anti-Reticulin Antibodies.

23. Apolipoprotein A1.

24. Apolipoprotein B.

25. Ascorbic Acid (ascorbate) Vitamin C.

26. Aspartate Transaminase.

27. Beta-Carotene (Carotene).

28. Bilirubin (total, total conjugated, unconjugated, direct and indirect).

29. Blood Group ABO and RhD.

30. Blood Urea Nitrogen (BUN).

31. Bun / Creatinine Ratio.

32. CA125.

33. CA15-3.

34. Calcium, Calcium ionized.

35. Candida Antibodies (IgM, IgG, IgA).

36. Carbon Dioxide Bicarbonate.

37. Carcinoembryonic Antigen.

38. Ceruloplasmin.

39. Chloride.

40. Cholinesterase, pseudo or true.

41. Coenzyme Q10.

42. Complement proteins – C3 (B1C) and Complement proteins – C4 (B1E).

43. Complete Blood Count.

44. Copper.

45. Cortisol – bound and unbound, no differentiation.

46. C-peptide immunoreactivity.

47. C-Reactive Protein (CRP).

48. C-Reactive Protein – High Sensitivity.

49. Creatine Phosphokinase.

50. Creatinine.

51. Creatinine Clearance.

52. Cystathionine.

53. Dehydroepiandrosterone sulphate (DHEAS).

54. Digitalis purpurea (digoxin).

55. Electrophoresis – including total protein.

56. Endomysial Antibody.

57. Erythrocyte Sedimentation Rate (ESR) (Sedimentation Rate).

58. Estradiol.

59. Estriol.

60. Estrogen.

61. Estrone.

62. Fatty acids, free.

63. Ferritin.

64. Fibrinogen semi-quantitative and quantitative.

65. Folate.

66. FSH.

67. Galectin 3.

68. Gamma-glutamyl Transferase (GGT) / GG transpeptidase (GGTP).

69. Gliadin Antibodies (IgG, IgA).

70. Glomerular Filtration Rate (GFR).

71. Glucose-6-Phosphate Dehydrogenase (G-6-PD).

72. Glucose, quantitative.

73. Glucose Tolerance Test.

74. Glutathione.

75. Hemoglobin – A1C.

76. Homocysteine.

77. Histocompatibility Testing – HLA 27 typing.

78. Immunoglobulin (globulin).

79. Insulin, Fasting and Non-fasting.

80. Insulin-Like Growth Factor 1.

81. Intrinsic Factor Blocking Antibody.

82. Iron, total – with iron binding capacity and per cent saturation.

83. Islet Cell Cytoplasmic Autoantibody.

84. Lactate dehydrogenase.

85. Lactate, Lactic Acid.

86. Lead.

87. Leptin.

88. Lipase.

89. Luteinizing Hormone.

90. Lyme Disease Antibodies.

91. Magnesium.

92. Memory Lymphocyte Immuno-Stimulation Assay (MELISA Test).

93. Mercury.

94. Mononuclear Heterophile Antibodies (Monospot).

95. Natriuretic Peptide – Brain (BNP).

96. Parathyroid hormone.

97. PCB (polychlorinated biphenyls).

98. Phosphatase, alkaline.

99. Phosphorus (inorganic phosphate).

100. Potassium.

101. Pregnenolone.

102. Progesterone.

103. Prolactin.

104. Protein, Total (albumin / globulin ratio).

105. Prothrombin time and International Normalized Ratio (INR).

106. PSA, Ratio.

107. Reticulocyte count.

108. Retinol, Vitamin A.

109. Reverse T3.

110. Rheumatoid factor.

111. S-adenosylhomocysteine.

112. S-adenosyl methionine.

113. Sex Hormone Binding Globulin (SHBG).

114. Sodium.

115. Testosterone.

116. Testosterone, free.

117. Thyroglobulin.

118. Thyroid Peroxidase Antibody.

119. Thyroid Stimulating Immunoglobulin (TSI).

120. Thyroxine Free (FT4).

121. Total Cholesterol panel – HDL / LDL / lipoprotein phenotyping (includes sample appearance, cholesterol, triglycerides, Lipopro VLDL cholesterol [calculated estimate]).

122. Trace Minerals.

123. Transferrin.

124. Transglutaminase IgA Antibody.

125. Trichlorobenzene.

126. Triiodothyronine Free (T3).

127. TSH (thyroid stimulating hormone).

128. Uric Acid (Urate).

129. Vitamin B (all tests).

130. Vitamin D 1,25-dihydroxy.

131. Vitamin D, 25-hydroxy.

132. Volatile solvents.

133. Zinc.

Tests Performed on Stool

134. Bacteria / yeast (microbiology profile).

135. Calprotectin Fecal.

136. Comprehensive Digestive Stool Analysis.

137. Elastase.

138. Fecal Fat.

139. Occult Blood.

140. Parasites and Ova.

Tests Performed on Urine

141. 5α-dihydrotestosterone (DHT).

142. Aldosterone.

143. Bilirubin (total, total conjugated, unconjugated, direct and indirect).

144. Bisphenol A.

145. Calcium, Calcium ionized.

146. Chlorinated pesticides.

147. Cortisol – bound and unbound, no differentiation.

148. Cortisol / Cortisone.

149. Creatinine Clearance.

150. Cultures – urine, screening, actual culture without identification.

151. Dehydroepiandrosterone sulphate (DHEAS).

152. Estradiol.

153. Estriol.

154. Estrogen.

155. Estrone.

156. Human Growth Hormone.

157. Luteinizing Hormone.

158. Melatonin.

159. Oxytocin.

160. Porphyrins, screen.

161. Progesterone.

162. Routine Urinalysis (glucose, blood, ketone, leukocytes, etc.)

163. Testosterone.

164. Testosterone, free.

165. Thyroid hormones.

166. Toxic Metals.

167. Uric acid (urate).

168. Urinary Organic Acid Test.

Tests Performed on Saliva

169. 17-OH-Progesterone.

170. 5α-dihydrotestosterone (DHT).

171. Aldosterone.

172. Androstenedione.

173. Cortisol – bound and unbound, no differentiation.

174. Dehydroepiandrosterone sulphate (DHEAS).

175. Esterol.

176. Estradiol.

177. Estriol.

178. Estrogen.

179. Estrone.

180. Melatonin.

181. Progesterone.

182. Testosterone.

183. Testosterone, free.

Tests Performed on Hair

184. Heavy Metal – hair element analysis.

Tests Performed on Tissue/Discharge/Sputum

185. Culture – throat swab for streptococcus screen only.

186. Culture and sensitivities (other swabs or pus – culture and smear [includes screening]).

187. Culture and sensitivities (sputum – culture and smear).

188. Nail and skin cultures.

189. Nasal swabs (other swabs or pus – culture and smear [includes screening]).

190. Pap smear (smear only, gram or Papanicolaou stain as sole procedure).

191. Seminal fluid examination (complete).

Tests Performed on Breath

192. Hydrogen breath test.

193. Intestinal permeability test.

194. Urea breath test for H. pylori.

O. Reg. 170/15, s. 4.

APPENDIX B
Tests for which a Naturopath may Take or Collect Specimens

Tests Performed on Stool

1. Bacteria / yeast (microbiology profile).

2. Calprotectin Fecal.

3. Comprehensive Digestive Stool Analysis.

4. Elastase.

5. Fecal Fat.

6. Occult Blood.

7. Parasites and Ova.

Tests Performed on Urine

8. 5α-dihydrotestosterone (DHT).

9. Aldosterone.

10. Bilirubin (total, total conjugated, unconjugated, direct and indirect).

11. Bisphenol A.

12. Calcium, Calcium ionized.

13. Chlorinated pesticides.

14. Cortisol – bound and unbound, no differentiation.

15. Cortisol/Cortisone.

16. Creatinine Clearance.

17. Cultures – urine, screening, actual culture without identification.

18. Dehydroepiandrosterone sulphate (DHEAS).

19. Estradiol.

20. Estriol.

21. Estrogen.

22. Estrone.

23. Human Growth Hormone.

24. Luteinizing Hormone.

25. Melatonin.

26. Oxytocin.

27. Porphyrins, screen.

28. Progesterone.

29. Routine Urinalysis (glucose, blood, ketone, leukocytes, etc.)

30. Testosterone.

31. Testosterone, free.

32. Thyroid hormones.

33. Toxic Metals.

34. Uric acid (urate).

35. Urinary Organic Acid Test.

Tests Performed on Saliva

36. 17-OH-Progesterone.

37. 5α-dihydrotestosterone (DHT).

38. Aldosterone.

39. Androstenedione.

40. Cortisol – bound and unbound, no differentiation.

41. Dehydroepiandrosterone sulphate (DHEAS).

42. Esterol.

43. Estradiol.

44. Estriol.

45. Estrogen.

46. Estrone.

47. Melatonin.

48. Progesterone.

49. Testosterone.

50. Testosterone, free.

Tests Performed on Hair

51. Heavy Metal – Hair element analysis.

Tests Performed on Tissue/Discharge/Sputum

52. Culture – throat swab for streptococcus screen only.

53. Culture and sensitivities (other swabs or pus – culture and smear [includes screening]).

54. Culture and sensitivities (sputum – culture and smear).

55. Nail and skin cultures.

56. Nasal swabs (other swabs or pus – culture and smear [includes screening]).

57. Pap smear (smear only, gram or Papanicolaou stain as sole procedure).

58. Seminal fluid examination (complete).

Tests Performed on Breath

59. Hydrogen breath test.

60. Intestinal permeability test.

61. Urea breath test for H. pylori.

O. Reg. 170/15, s. 4.

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

 

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