Section 177-7-007 - CLASS D PERMITS FOR CONFIRMATORY TESTING007.01 Qualifications for Class D Permit Holder Class D permit holder qualifications for the chemical analyses of an individual's urine, for drug content by confirmatory testing using an approved method(s) and a Gas Chromatograph/Mass Spectrometer (GC/MS) are:
7-007.01A Be not less than the legal age of majority as established by state statutes.7-007.01B Have knowledge of the chemistry of drugs and drug metabolites. Have the ability to perform confirmatory tests for the presence of drugs in urine. Evidence of knowledge and ability consists of the following proof: 7-007.01B1 Twelve semester hours of academic work in chemistry from a recognized college or university.7-007.01C Have knowledge of the theory of Gas Chromatograph/Mass Spectrometer (GC/MS) methods, the operation of the GC/MS, including it's calibration and maintenance. Evidence of knowledge and ability consists of the following proof: 7-007.01C1 Documentation of education or training covering GC/MS applications.7-007.01D Have demonstrated competence to the satisfaction of the Department of Health and Human Services. Satisfactory competence shall be, for the purpose of these rules and regulations, the satisfactory performance of analysis on proficiency samples in a performance evaluation study as described in 177 NAC 7-006.03.007.02 Issuance of Class D Permits for GC/MS Confirming tests7-007.02A Application for Class D permits shall be made on forms provided by the Department of Health and Human Services. The application shall be of the form as shown in Attachment 2, attached and incorporated herein by reference.7-007.02B An applicant for a Class D permit shall, at the time of making application: 7-007.02B1 state the identity of the manufacturer of the GC/MS intended to be used. The applicant will notify the Division of Public Health if there is a change in GC/MS information.007.03 Performance Evaluation Studies 7-007.03A Ongoing performance evaluation studies shall be in effect, with acceptable performance, for confirmatory tests to be valid. Ongoing performance shall be enrollment in a recognized proficiency testing service as specified in 177 NAC 7-006.03. All provisions in 177 NAC 7-006.03, except 177 NAC 7-006.03B, apply to confirmatory testing using a GC/MS method and technique. Copies of proficiency testing evaluations for proficiency test samples analyzed on the GC/MS shall be provided to the Department of Health and_Human Services.007.04 List of Approved Methods 7-007.04A GC/MS analysis which shall include scientifically accepted techniques that have been validated by the laboratory utilizing them.007.05 Sample Handling for GC/MS Confirmatory Testing7-007.05A When samples must be transported to a testing site for confirmatory testing, it is the responsibility of the originating agency to forward all positive initial screening samples to a Class D permit holder authorized to perform confirmatory testing.7-007.05B While not in transit to a site for confirmatory testing and while not under actual testing, the sample shall be placed in secured refrigerated storage at four degrees centigrade, or less.7-007.05C When transporting samples to another site for confirmatory testing, the sample shall be repackaged and sealed with an evidence seal. The repackaging shall include all containers, papers, and materials submitted to the initial testing site.007.06 Approved Technique for use with an approved GC/MS method 7-007.06A Scientifically acceptable solid phase or liquid/liquid extraction technique which has been validated by the laboratory performing the extraction.007.07 Operating Rules for Class D Perm for GC/MS Confirmatory Tests 7-007.07A A Class D permit holder for the confirmatory tests to determine the presence of a drug in urine shall follow all of the provisions in 177 NAC 7-006.05.007.08 Maintenance and Repair of GC/MS Instruments 7-007.08A Maintenance of GC/MS instruments shall be performed as prescribed in the operators manual that is intended for the GC/MS which may be utilized to produce results with a confirmatory testing technique in this regulation. Maintenance shall be performed by a person trained by the manufacturer as specified in 177 NAC 7-007.01C and 177 NAC 7-007.01C1. Maintenance may also be performed by a manufacturer's representative.7-007.08B Repair of an instrument shall be performed by a manufacturer's representative or by a person trained by the manufacturer.7-007.08C Malfunctions of the GC/MS, maintenance activities, and repair occurrences shall be recorded and shall show the name of the person and the agency or business organization performing maintenance activities and repair work. Approved by Attorney General: August 27, 2007
Approved by Governor: September 14, 2007
Filed with Secretary of State: September 14, 2007
177 Neb. Admin. Code, ch. 7, § 007