Rule 92-3-.06 - Techniques and Methods(2) All chemical tests on blood and/or urine not performed by Georgia Bureau of Investigation personnel must be performed on instruments approved by the Director of the Division of Forensic Sciences. Requests for approval of instruments to perform chemical testing of blood and urine along with proposed maintenance guidelines will be submitted to the Director of the Division of Forensic Sciences or his or her designee. Approval of such request is at his or her discretion pursuant to O.C.G.A. § 40-6-392. Upon approval of any testing instrument for the analysis of blood and/or urine a certificate of approval shall be issued detailing the agency, the date approved, the instrument serial number, and the date of the approval expiration. Such certificate shall be self authenticating and evidence that the instrument was approved by the Division of Forensic Sciences as required by O.C.G.A. § 40-6-392. Such approval shall not apply when any substantial modification to the instrument's original design has been made such that it no longer has all its parts attached and in working order as prescribed by the manufacturer or when the instrument is not in substantial compliance with the maintenance guidelines submitted. Failure to maintain testing instruments as stated in the guidelines for instrument maintenance may be considered grounds for revocation of the certificate of approval. Factors evaluated in the approval of maintenance guidelines for testing instruments shall include but are not limited to: (a) Documentation of substantial compliance with the manufacturer's recommendations for maintenance;(b) Documentation of all maintenance performed including the date, action taken, the individual performing the maintenance, and the results of the maintenance including acceptable performance of known quality control samples following such maintenance;(c) Documentation that instrument maintenance is performed by individuals sufficiently trained to perform instrument maintenance;(d) Documentation that the instrument has all its parts attached and in good working order as prescribed by the manufacturer;(e) Documentation that the instrument is suitable for the purpose for which it is being used;(f) Documentation of quality control measures to ensure reliable analysis such as positive and negative controls;(g) Documentation that the instrument exhibits the sensitivity, resolution, and specificity necessary for its intended purpose and is evaluated for suitability prior to use.(3) Types of instruments considered for confirmatory testing of blood or urine for drug content include gas chromatography mass spectrometry, gas chromatography tandem mass spectrometry, liquid chromatography mass spectrometry, liquid chromatography tandem mass spectrometry, or other comparable structural elucidation technique as determined by the Director of the Division of Forensic Sciences or his or her designee.(4) Types of instruments considered for testing of blood for alcohol content include head space gas chromatograph, fluorescence polarization immunoassay, cloned enzyme donor immunoassay, enzyme immunoassay, or other comparable technique as determined by the Director of the Division of Forensic Sciences or his or her designee.(5) Breath tests other than the original alcohol-screening test shall be conducted on a breath alcohol analyzer approved by the Director of the Division of Forensic Sciences or his or her designee. Any other type of breath alcohol analyzer not specifically listed in this paragraph must be approved by the Director of the Division of Forensic Sciences or designee prior to its use in the State. (a) The Intoxilyzer Model 5000 manufactured by CMI, Inc. is an approved instrument for breath alcohol tests conducted on or before December 31, 2015;(b) The Intoxilyzer Model 9000 manufactured by CMI, Inc. is an approved instrument for breath alcohol tests conducted on or after January 1, 2013;(6) All breath tests other than the original alcohol-screening test will be performed in accordance with Rule 92-3-.02(2) of these regulations. The operator's permit will be conspicuously displayed in the room and in the immediate vicinity of the place where the test is conducted, or the operator will have on his or her person or immediate possession for display upon request a valid permit in accordance with Rule 92-3-.02(2).(7) All blood and urine drug tests will be performed by the Georgia Bureau of Investigation, Division of Forensic Sciences or by entities specifically approved by the Director of the Division of Sciences for this purpose. All entities approved by the Division of Forensic Sciences to perform chemical analyses of blood and urine for drugs shall be accredited by a nationally recognized accrediting body. A list of all entities approved for the purpose of conducting chemical tests for drugs will be kept on file at the Georgia Bureau of Investigation to be made available upon request. Approval of entities to perform chemical tests of blood or urine for drugs shall be at the discretion of the Director of the Division of Forensic Sciences or his or her designee. Such approval shall not apply when any substantial change to the method submitted has been made or when any person executing such method fails to substantially comply with the method as written when submitted for approval. Entities requesting approval to perform chemical tests of blood and/or urine for drugs must submit all methods used for chemical testing under O.C.G.A. § 40-6-392as well as accompanying calibration procedures and validation documents. All blood and urine drug testing methods submitted to the Division of Forensic Sciences for approval shall be evaluated for the following: (a) Whether the method is suitable for the purpose for which it was submitted;(b) Whether the method employs a minimum of two analytical techniques for positive identification of an analyte where at least one of the techniques is structurally elucidating (e.g., gas chromatography/ mass spectrometry, liquid chromatography/ mass spectrometry or liquid chromatography/ mass spectrometry/mass spectrometry);(c) Whether the method includes quality control measures to ensure reliable analysis such as positive and negative controls;(d) Whether the method's accuracy and measurement uncertainty for quantification meet acceptance criteria as determined by the Director of the Division of Forensic Sciences or his or her designee. These acceptance criteria are based on minimum acceptability requirements set forth for the Division of Forensic Sciences and will be made available to the applicant agency on request;(e) Whether the method's working range for quantification includes the relevant pharmacological concentrations for the analytes of interest;(f) Whether the method is specific for the analytes of interest;(g) Whether the method complies with a nationally recognized quality control standard such as ISO/IEC 17025.(8) The Director, Division of Forensic Sciences: (a) will cause each instrument used in the administration of breath tests to be checked periodically for calibration and operation and a record of the results of all such checks maintained;(b) at his discretion may cause any operator administering breath tests to be checked for operating proficiency. Unsatisfactory operation proficiency checks shall be one of several criteria for permit revocation.(9) All blood and/or urine alcohol tests will be performed in accordance with a quantitative Gas Chromatographic technique or any equivalent procedure comparable in accuracy to Gas Chromatography. Any method used by an entity other than the Division of Forensic Sciences will be evaluated for approval by the Director of the Division of Forensic Sciences or his or her designee and such approval shall be at his or her discretion. Upon approval of any testing method a certificate of approval shall be issued detailing the agency, the date approved, and the date of the approval expiration. Such certificate shall be self authenticating and evidence that the method submitted was approved by the Division of Forensic Sciences as required by law. Such approval shall not apply when any substantial change to the method submitted has been made or when any person executing such method fails to substantially comply with the method as written when submitted for approval. Entities requesting approval to perform blood and/or urine alcohol tests must submit all methods used for testing under O.C.G.A. § 40-6-392as well as accompanying calibration procedures and validation documents. Factors evaluated in the approval of testing methods by outside agencies shall include: (a) Whether the method is generally accepted in the scientific community for the purpose for which it is being submitted;(b) Whether the method employs replicate analysis;(c) Whether the method includes quality control measures to ensure reliable analysis such as positive and negative controls;(d) Whether the method's accuracy and measurement uncertainty for quantification meet acceptance criteria as determined by the Director of the Division of Forensic Sciences or his or her designee. These acceptance criteria are based on minimum acceptability requirements set forth for the Division of Forensic Sciences and will be made available to the applicant agency on request;(e) Whether the method's working range for quantification includes all alcohol levels between 0.02 and 0.40 g/dL of blood or equivalent;(f) Whether the method is specific for ethanol;(g) Whether the method complies with a nationally recognized quality control standard such as ISO/IEC 17025.(10) The Director of the Division of Forensic Sciences, at his discretion, may require any person authorized to perform chemical tests and/or report results of such testing of blood or urine to divide a specimen and after analysis submit it to the Director, with his report of the specimen. Alternatively, the Director may submit a sample of known alcohol or drug content to any person holding a permit to analyze blood or urine or require them to participate in an external proficiency testing program of his or her choice at his or her discretion. The failure to submit a sample or to satisfactorily analyze a specimen on request will be one of several criteria for revocation of a permit.(11) Except as forbidden by law, a report of every evidential breath test, excluding initial alcohol-screening tests, shall be made by the individual authorized to issue such reports.(12)(a) The methods approved by the Division of Forensic Sciences for conducting an evidential breath alcohol analysis shall consist of the following: (1) the analysis shall be conducted on an approved instrument as defined in 92-3-.06(5).(2) the analysis shall be performed by an individual holding a valid permit, in accordance with Rule 92-3-.02(2); and(3) the testing instrument shall have been checked periodically for calibration and operation, in accordance with Rule 92-3-.06(8)(a);(b) Administrative, procedural, and/or clerical steps performed in conducting a test shall not constitute a part of the approved method of analysis.Ga. Comp. R. & Regs. R. 92-3-.06
O.C.G.A. Secs. 6-2-5.1, 27-3-7, 35-3-154, 40-6-392, 52-7-12.
Original Rule entitled "Techniques and Methods" adopted. F. Apr. 11, 1986; eff. May 1, 1986.Amended: F. Sept. 19, 1994; eff. Oct. 9, 1994.Amended: F. Nov. 9, 1994; eff. Nov. 29, 1994.Amended: F. Nov. 18, 1995; eff. Dec. 8, 1995.Amended: F. Nov. 12, 1997; eff. Dec. 2, 1997.Amended: F. Feb. 24, 2000; eff. Mar. 15, 2000.Amended: F. Mar. 26, 2010; eff. Apr. 15, 2010.Amended: F. Jan. 3, 2013; eff. Jan. 23, 2013.