Section 177-7-006 - CLASS D PERMITS FOR INITIAL SCREENS BY CHEMICAL METHODS006.01 Qualifications for Class D Permit Holder Class D permit holder qualifications for analysis by chemical tests of an individual's urine for drug content are:
7-006.01A Be not less than the legal age of majority as established by state statutes.7-006.01B Have knowledge of the theory of the instrument used for initial screens, the operation of the instrument, the calibration of the instrument, the maintenance of the instrument, and the steps in the technique of initial screen drug detection.7-006.01C Have proof of knowledge and ability consisting of a letter or certificate of training provided to the Department of Health and Human Services from the instrument manufacturer certifying attendance and completion of at least sixteen hours of training covering the topics in 177 NAC 7-006.01B.7-006.01D 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 7-006.03.006.02 Issuance of Class D Permits for Initial Screens 7-006.02A Applications 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 1, attached and incorporated herein by reference.7-006.02B An applicant for a Class D permit shall, at the time of making application: 7-006.02B1 State the identity of the method(s) that has been selected for use from the list of approved methods in 177 NAC 7-006.04.7-006.02B2 Submit the technique showing the written instructions which describes the procedure, equipment, and equipment preventive maintenance schedule.006.03 Performance Evaluation Studies A performance evaluation for permit issuance shall consist of providing copies of the results of sample testing or the graded performance from a recognized proficiency testing service.
For the purpose of these regulations an ASCLD-LAB approved proficiency test provider must be used. Unacceptable performance is defined as a false positive result for any drug in a one shipment survey.
7-006.03A Ongoing performance evaluation studies shall be in effect, with acceptable performance, for test results to be valid. Ongoing performance evaluation shall be enrollment in an ASCLD-LAB approved drug proficiency testing program. Unacceptable performance is defined as a false positive result for a drug in two successive survey shipments. Copies of proficiency testing evaluations shall be provided to the Department of Health and Human Services.7-006.03B Initial screen testing shall not be subject to participation in a recognized proficiency testing service as specified in 177 NAC 7-006.03 and 177 NAC 7-006.03A. Initial screen permit holders shall participate in a performance evaluation by the Department of Health and Human Services. Unacceptable performance as defined in 177 NAC 7-006.03 applies to initial screen permit applicants, and as defined in 177 NAC 7-006.03A for ongoing performance evaluation surveys. An ongoing performance evaluation shall be one survey shipment annually for initial screen permit holders.7-006.03C Reporting of test results for the presence or absence of drugs in the urine of individuals shall not occur by a permit holder who has been notified of unacceptable performance in proficiency testing.7-006.03D A permit holder shall be allowed two attempts to produce acceptable performance after being notified of unacceptable performance.7-006.03E A permit holder shall not resume reporting of test results for the presence or absence of drugs in the urine of individuals until the Department of Health and Human Services notifies a permit holder that he/she is again in an acceptable performance status following unacceptable performance.006.04 List of Approved Methods and Techniques for Initial Screen Testing 7-006.04A ENZYME MULTIPLIED IMMUNOASSAY TECHNIQUE (EMIT)7-006.04A1 The enzyme multiplied immunoassay technique is an approved initial screen method. Testing must be performed according to the instrument manufacturer's instructions.7-006.04B FLUORESCENCE POLARIZATION IMMUNOASSAY (FPIA).7-006.04B1 The fluorescence polarization immunoassay method u is an approved initial screen method. Testing must be performed according to the instrument manufacturer's instructions.006.05 Operating Rules for Class D Permit A Class 5 permit holder for the determination of drug content in urine shall:
7-006.05A Accept for testing only the specimen type of urine, as listed on the permit.7-006.05B Be responsible for maintaining the legal continuity of all specimens received.7-006.05C Perform all tests using the approved method as named on the Class D permit and in a manner that consists of the technique for the method as found in these rules and regulations.7-006.05D Conduct all tests for each drug with the inclusion of quality control samples in the test run. The test run may include more than one person's sample for a particular drug; the quality control samples shall be of the same drug that is tested in a test run. The quality control sample result shall be used to: 7-006.05D2 Determine if test results are to be reported. No test results shall be reported if a quality control sample result is outside of acceptable limits. Acceptable limits for reporting test results shall be no greater than ± three standard deviations, except for initial screen techniques that utilize an instrument that does not produce numerical data.7-006.05D3 The EMIT technique in 177 NAC 7-006.04A utilizes an instrument that does not produce numerical data, therefore, no test result shall be reported if a positive control sample does not give a positive result or if a negative control sample does not give a negative result.7-006.05F Maintain the following records: 7-006.05F1 The permit to perform chemical tests.7-006.05F2 Records of specimen receipts, tests performed and results.7-006.05F3 The method and description of technique steps in use by the permit holder along with documentation of validation of technique.7-006.05F4 The records of quality control results and related data as prescribed in 177 NAC 7-006.05D of this subsection.7-006.05F5 A current copy of these rules and regulations.7-006.05F6 The records of maintenance and repair performed on an instrument, as prescribed in 177 NAC 7-006.06.006.06 Maintenance and Repair of Instruments 7-006.06A Maintenance of instruments shall be performed as prescribed in the operators manual that is intended for an instrument which may be utilized to produce results with a technique in this regulation. Maintenance shall be performed by a person trained by the manufacturer as specified in 177 NAC 7-006.01B and 177 NAC 7-006.01C. Maintenance may also be performed by a manufacturer's representative.7-006.06B Repair of an instrument shall be performed by a manufacturer's representative or by a person trained by the manufacturer.7-006.06C 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.177 Neb. Admin. Code, ch. 7, § 006