ontario regulation 355/25

made under the

Laboratory and Specimen Collection Centre Licensing Act

Made: December 11, 2025
Filed: December 15, 2025
Published on e-Laws: December 16, 2025
Published in The Ontario Gazette: January 3, 2026

Amending O. Reg. 45/22

(GENERAL)

1. (1) Subsection 19 (1) of Ontario Regulation 45/22 is revoked and the following substituted:

Restrictions re prenatal assessments and newborn screening

(1) The owner and the operator of a laboratory shall ensure that no person employed in the laboratory performs a test to screen for Aneuploidies, Fetal Blood Group genotyping (including Fetal RHD) or first-trimester preeclampsia biomarkers under the provincial prenatal screening program unless,

(a)  the laboratory is operated by the Children’s Hospital of Eastern Ontario — Ottawa Children’s Treatment Centre; or

(b)  the owner or the operator of the laboratory has entered into an agreement with the Children’s Hospital of Eastern Ontario — Ottawa Children’s Treatment Centre respecting conditions related to the participation of the laboratory in the provincial prenatal screening program.

(2) Subsection 19 (3) of the Regulation is revoked and the following substituted:

(3) The owner and the operator of a laboratory shall ensure that no person employed in the laboratory performs a test for the disorders listed in subsection (4) if the requisition indicates that the test is for newborn screening unless,

(a)  the laboratory is operated by the Children’s Hospital of Eastern Ontario — Ottawa Children’s Treatment Centre; or

(b)  the owner or the operator of the laboratory has entered into an agreement with the Children’s Hospital of Eastern Ontario — Ottawa Children’s Treatment Centre respecting conditions related to the participation of the laboratory in the newborn screening program.

(4) The disorders mentioned in subsection (3) are as follows:

1.  Amino acidopathies.

2.  Biotinidase deficiency.

3.  Cystic fibrosis.

4.  Endocrinopathies.

5.  Fatty acid oxidation defects.

6.  Galactosemia.

7.  Hemoglobinopathies.

8.  Mucopolysaccharidosis type I.

9.  Organic acidemias.

10.  Permanent hearing loss risk.

11.  Severe combined immune deficiency.

12.  Spinal muscular atrophy.

13.  X-ALD (X-linked adrenoleukodystrophy).

2. Section 20 of the Regulation is amended by striking out “test for colorectal cancer” and substituting “test to screen for colorectal cancer”.

3. The Regulation is amended by adding the following section:

Midwives and aboriginal midwives

25.1 (1) A member of the College of Midwives of Ontario is exempt from sections 9 to 16 of the Act and from this Regulation with respect to performing one or more point-of-care tests listed in subsection (3) in the course of their midwifery practice.

(2) An aboriginal midwife is exempt from sections 9 to 16 of the Act and from this Regulation with respect to performing one or more point-of care tests listed in subsection (3) in the course of their aboriginal midwifery practice.

(3) The point-of-care tests mentioned in subsections (1) and (2) are as follows:

1.  Amniotic swab.

2.  Glucose.

3.  Pregnancy test.

4.  Strep B rapid screen.

5.  Urine dipstick.

4. (1) Paragraph 26 of Schedule 1 to the Regulation is revoked and the following substituted:

26.  Aspartate transaminase (AST).

(2) Paragraph 29 of Schedule 1 to the Regulation is revoked and the following substituted:

29.  Blood Group — ABO and RhD.

(3) Paragraph 68 of Schedule 1 to the Regulation is revoked and the following substituted:

68.  Gamma-glutamyl transferase (GGT).

(4) Paragraph 84 of Schedule 1 to the Regulation is revoked and the following substituted:

84.  Lactate dehydrogenase (LDH), total.

(5) Paragraph 98 of Schedule 1 to the Regulation is revoked and the following substituted:

98.  Phosphatase, alkaline (ALP).

(6) Schedule 1 to the Regulation is amended by adding the following paragraph:

114.1  T-4, free absolute.

(7) Paragraph 120 of Schedule 1 to the Regulation is revoked.

5. Schedule 2 to the Regulation is revoked and the following substituted:

Schedule 2
Tests — Requisition by Midwife, Section 18

1.  Alanine transaminase (ALT).

2.  Albumin quantitative.

3.  Alloimmunized fetal blood group genotyping.

4.  Alphafetoprotein screen.

5.  Antibody identification.

6.  Antibody screen.

7.  Bile acid total and fractionation.

8.  Bilirubin — conjugated.

9.  Bilirubin — total.

10.  Bilirubin — unconjugated.

11.  Blood Group — ABO and RhD.

12.  Blood Group — per antigen.

13.  Cervicovaginal cellular evaluation (Pap smear).

14.  Chlamydia.

15.  Chlamydia by Nucleic Acid Amplification Test (NAAT).

16.  Complete blood count (any method).

17.  Creatinine, including estimated glomerular filtration rate (eGFR).

18.  Culture — cervical, vaginal (includes GC).

19.  Culture — other swabs or pus.

20.  Culture — urine.

21.  Cytomegalovirus (CMV) by PCR.

22.  Direct anti-human globulin test.

23.  Estriol.

24.  Fetal fibronectin.

25.  Fetal RHD screening.

26.  Gamma-glutamyl transferase (GGT).

27.  Glucose.

28.  Glucose tolerance test in pregnancy.

29.  Glycosylated hemoglobin — HbA1c.

30.  Gonorrhea by Nucleic Acid Amplification Test (NAAT).

31.  Hemoglobin electrophoresis or chromatography to include Hb A2 (Hemoglobin A2) fraction.

32.  Hepatitis associated antigen or antibody immunoassay.

33.  Hepatitis B surface antigen.

34.  Human Chorionic Gonadotropin.

35.  Human papillomavirus (HPV).

36.  Inhibin.

37.  Kleihauer.

38.  Lactate dehydrogenase (LDH), total.

39.  Newborn screening test for amino acidopathies, biotinidase deficiency, cystic fibrosis, endocrinopathies, fatty acid oxidation defects, galactosemia, hemoglobinopathies,  mucopolysaccharidosis type I, organic acidemias, permanent hearing loss risk, severe combined immune deficiency, spinal muscular atrophy or X-ALD (X-linked adrenoleukodystrophy).

40.  Non-invasive prenatal testing (NIPT), common aneuploidies.

41.  Phosphatase, alkaline (ALP).

42.  Placental growth factor (P1GF).

43.  Polymerase Chain Reaction (PCR), urine testing and serology for Zika virus.

44.  Potassium.

45.  Pregnancy-associated plasma protein A (PAPP-A).

46.  Pregnancy test.

47.  Protein, total.

48.  Protein, total (24-hour urine, total protein).

49.  Serology HIV antibody.

50.  Serum ferritin.

51.  Serum folate.

52.  Sickle cell solubility test (screen).

53.  Smear only, Gram or Papanicolaou stain.

54.  Strep B rapid screen.

55.  T-3, total (triiodothyronine).

56.  T-4, free absolute.

57.  Toxoplasmosis.

58.  TSH (thyroid stimulating hormone).

59.  Uric acid (Urate).

60.  Urinalysis — routine (includes microscopic).

61.  Varicella zoster virus (VZV).

62.  Venereal Disease Research Laboratory (VDRL) test.

63.  Virus antibodies — hemagglutination inhibition or ELISA technique (Rubella).

64.  Virus isolation.

65.  Vitamin B12.

66.  Vitamin D, 25-hydroxy.

67.  Wet preparation (for fungus, trichomonas, parasites).

Commencement

6. This Regulation comes into force on the day it is filed.