PURPOSE: This rule establishes the approved methods for the analysis of blood, saliva, and urine for the presence of drugs.

1. (1) Samples of blood, saliva, or urine shall be collected in accordance with the provisions of sections 577.029, and 306.111–306.119, RSMo, and a sufficient volume of sample shall be collected to provide for duplicate testing. SENIOR SERVICES

   1. (A) Blood samples shall be collected in commercially-manufactured blood collection tubes that contain sodium fluoride or an equivalent preservative, as well as potassium oxalate, sodium citrate, or an equivalent anticoagulant.
   2. (B) Urine specimens shall be collected in clean, dry containers. If a preservative, such as sodium fluoride, is employed, a comment stating the type and amount of preservative used should accompany the specimen. Specimens shall be refrigerated or frozen if not tested within one (1) day of collection.
   3. (C) Saliva specimens shall be collected in a commercially-manufactured collection device and collected according to collection device instructions.
2. (2) An individual shall have a valid Type I permit in order to perform analyses of blood, saliva, and urine for the presence of drugs.
3. (3) The laboratory in which these analyses are performed shall have a director who shall assume full responsibility for the accuracy of tests and reports.
4. (4) The laboratory in which these analyses are performed shall have, by July 1, 2014, a national accreditation through the College of American Pathologists (CAP), the American Board of Forensic Toxicologists (ABFT), or through the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/Lab). This accreditation shall continue as long as the laboratory performs analysis of blood, saliva, or urine for the presence of drugs and shall include an annual proficiency test on each biological matrix (blood, saliva, or urine) tested. A copy of the accreditation for each laboratory shall be supplied to the State Public Health Laboratory upon request.

5. (5) The following methodologies are approved for the analysis of blood, saliva, and urine for the presence of drugs:

   1. (A) Enzyme immunoassay (EIA);
   2. (B) Fluorescence immunoassay (FPIA);
   3. (C) Radioimmunoassay (RIA);
   4. (D) Gas-liquid chromatography (GC);
   5. (E) Thin layer chromatography (TLC);
   6. (F) High-pressure liquid chromatography (HPLC);
   7. (G) Ultra violet-visible spectrophotometry (UV/Vis);
   8. (H) Gas chromatography/mass spectrometry (GC/MS);
   9. (I) Liquid chromatography/mass spectrometry (LC/MS);
   10. (J) Enzyme-linked immunosorbent assay (ELISA); and
   11. (K) Cloned enzyme donor immunoassay (CEDIA).
6. (6) All positive results found upon initial testing shall be confirmed by a method employing mass spectrometry (MS).
7. (7) Blood and urine tests for the presence of drugs performed prior to the effective date of this rule shall be considered valid under this rule if such tests were completed in compliance with the rules in effect at the time the test was conducted.

AUTHORITY: sections 192.006 and 577.026, RSMo 2000, and sections 306.114, 306.117, 577.020, 577.037, RSMo Supp. 2011.* This rule previously filed as 19 CSR 20-30.080. Original rule filed July 15, 1988, effective Sept. 29, 1988. Changed to 19 CSR 20- 30.080 Jan. 1, 1995. Emergency amendment filed May 10, 2001, effective May 22, 2001, expired Nov. 17, 2001. Amended: Filed May 10, 2001, effective Oct. 30, 2001. Amended: Filed May 31, 2012, effective Dec. 30, 2012. *Original authority: 192.006, RSMo 1993, amended 1995; 306.114, RSMo 1993, amended 2004, 2005, 2008; 306.117, RSMo 1993, amended 2005, 2008; 577.020, RSMo 1977, amended 1982, 1983, 1996, 1998, 2001, 2006; 577.026, RSMo 1982; and 577.037, RSMo 1982, amended 1983, 1988, 1993, 1996, 2001.