Ga. Comp. R. & Regs. 111-8-10-.07

Current through Rules and Regulations filed through October 29, 2024

Rule 111-8-10-.07 - Application

(1) Applications for licensure of clinical laboratories shall be made on forms provided by the Department and shall indicate from the following list, those categories, subcategories and/or procedures for which the facility requests licensure:

(a) Clinical Chemistry;

1. Routine;

2. Urinalysis;

3. Special (includes Radiobioassay, Blood Gases, Medical Toxicology, Therapeutic Drug Monitoring, Immunohistochemistry, etc.)

(b) Hematology;

(c) Immunohematology (including Group/Type/Crossmatch, Antibody Screen/Identification, Storage, Transfusion Services, Pheresis/ Components, Donor Services (autologous, general), Histocompatibility.

(d) Microbiology;

1. Bacteriology (Level I - Direct microscopic examination of smears; Level II - Primary culture, report no growth and refer growth for identification; Level III - Culture and Identification and/ or Sensitivity Testing);

2. Mycobacteriology (Level I - Direct microscopic examination of smears for acid fast organisms; Level II - Primary culture, report no growth and refer growth for identification; Level III - Culture, Identification and/or Sensitivity Testing);

3. Mycology (Level I - Direct microscopic examination for fungi; Level II - Primary culture, report no growth and refer growth for identification; Level III - Culture, Identification and/or Sensitivity Testing);

4. Parasitology; and

5. Virology.

(e) Clinical Immunology and Serology:

1. Syphilis;

2. Non-syphilis;

3. Viral Serology;

4. HIV (Screening/Confirmation).

(f) Pathology;

1. Exfoliative Cytology;

2. Anatomic Pathology; and

3. Oral Pathology.

(g) Radiobioassay.

(h) Tissue Banking.

(i) Cytogenetics.

(j) Inherited Metabolic Disorder Testing of Newborns.

(k) Specimen Collection Station(s).

(l) Point of Care Testing.

(m) Other: (ART, andrology, molecular genetics).

(2) If a facility provides any laboratory testing services it must apply for and obtain one or more appropriate laboratory licenses (or screening and monitoring approvals) as needed to cover all laboratory services provided and must meet all requirements of these regulations. Where testing beyond the scope of authorized laboratory services is performed, these additional tests must be obtained from a duly licensed laboratory that meets all requirements of these regulations or from an out-of-state laboratory holding a current federal certificate for laboratory testing.

(3) The application for licensure in the category of specimen collection station shall be made on forms provided by the Department, and shall indicate the name and address of the laboratory or laboratories to which specimens are submitted for testing.

(4) Application for screening and monitoring approvals shall be made on forms provided by the Department and shall provide pertinent information as deemed necessary by the Department.

Ga. Comp. R. & Regs. R. 111-8-10-.07

O.C.G.A. § 31-22-1et seq.

Original Rule entitled "Application" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.