Section 177-1-006 - CLASS A PERMITS006.01Qualifications for Class A Permit Holder. A Class A permit holder shall have knowledge of the chemistry of alcohol and other substances of proper concern in body fluid alcohol tests and the ability to perform satisfactory tests for alcohol as demonstrated by: 006.01A Twelve semester hours of academic work in chemistry from a recognized college or university; or006.01B Two years of experience consisting of performance of routine laboratory tests in a usual and customary laboratory organization.006.02Issuance of Class A Permits.006.02A Applications for Class A permits shall be made on Attachment 8, attached and incorporated herein by reference.006.03Initial Performance Evaluation Studies Prior to Permit Issuance. A performance evaluation study for permit issuance shall consist of four audit samples. Satisfactory performance of analyses on the audit samples is defined as the ability to produce acceptable data on all samples.006.03A Unacceptable data is defined, for the purpose of section 006 of these regulations, as an error in the analysis of an audit sample greater than a 10.00% deviation. Percent deviation shall be computed as the total deviation from the mean value, divided by the mean value, and multiplied by 100.006.03B Results on audit samples shall be reported to the third decimal point.006.03C A prospective permit holder shall be allowed two attempts to produce acceptable data.006.04List of Approved Methods for Class A Permits.2. Enzymatic Alcohol Dehydrogenase3. Radiative Energy Attenuation006.05Operating Procedures for Class A Permit. A Class A permit holder for the determination of alcohol content in blood shall: 006.05A Be responsible for maintaining the legal continuity of all specimens received.006.05B Conduct all tests with an inclusion of a quality control sample in the test run. The quality control sample result shall be used to:006.05B1 Determine standard deviation data computed as shown: Click here to view
where: N = number of measurements
X = value of single measurement
-X = mean of all X's
006.05B2 Determine if test results are to be reported. No test results shall be reported if a quality control sample result is greater than +/- three standard deviations.006.05C On or before July 1 of each even-numbered year, Class A On or before July 1 of each even-numbered year, Class A permit holders must submit his/her reports of standard deviation data for the previous 24 month period of time to the Department.006.05DOngoing Performance Evaluation Studies for Permit Holders. Ongoing performance evaluation studies shall be in effect with acceptable performance for test results to be valid. An ongoing performance evaluation study shall be enrollment in the College of American Pathologists' Whole Blood Alcohol/Volatiles survey program or a survey program at the Department's discretion. Unacceptable performance is defined as two or more values outside of the acceptable ranges in two successive survey shipments. On or before July 1 of each even-numbered year, Class A permit holders shall submit his/her copies of proficiency testing evaluations for the previous 24 month period of time to the Department.006.05D1 Reporting of test results of alcohol content in blood of individuals shall not occur by a permit holder who has been notified of unacceptable performance in proficiency testing. 006.05D2 A permit holder shall be allowed two attempts to produce acceptable performance after being notified of unacceptable performance. 006.05D3 A permit holder shall not resume reporting of test results for alcohol content in blood of individuals until the Department notifies a permit holder that he/she is again in an acceptable performance status following an acceptable performance.006.05E Maintain the following records: 006.05E1 The permit to perform chemical tests. 006.05E2 Records of specimen receipts, tests performed and results. 006.05E3 The method and description of steps used by the permit holder. 006.05E4 Records of quality control results and related data as prescribed in part 006.05D of this subsection. 006.05E5 A current copy of these rules and regulations. 006.05E6 Records of maintenance performed on instrument.006.06Inspection, Maintenance, and Repair of Laboratory Instruments for Class A Methods.006.06A Maintenance of instruments shall be performed as prescribed in the Operators/manufacturers manual that is intended for an instrument which may be utilized to produce results in this regulation. Maintenance shall be performed by a person trained to do maintenance or a manufacturer's representative.006.06B When inspection of an instrument reveals the need for repair, the repair shall be performed by a manufacturer's representative, or by a person trained for repair.006.06C Malfunctions of instruments, 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.006.06D A Class A permit holder shall document that instrument maintenance has occurred with at least the frequency recommended by the manufacturer.177 Neb. Admin. Code, ch. 1, § 006