Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 177 - NEBRASKA DEPARTMENT OF HEALTH AND HUMAN SERVICES DIVISION OF PUBLIC HEALTH
Chapter 1 - RULES AND REGULATIONS RELATING TO ANALYSES FOR THE DETERMINATION OF THE ALCOHOL CONTENT IN BLOOD OR BREATH
Section 177-1-006 - CLASS A PERMITS
Universal Citation: 177 NE Admin Rules and Regs ch 1 ยง 006
Current through September 17, 2024
006.01 Qualifications 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; or
006.01B Two years of experience consisting of
performance of routine laboratory tests in a usual and customary laboratory
organization.
006.02 Issuance of Class A Permits.
006.02A Applications for Class A permits
shall be made on Attachment 8, attached and incorporated herein by
reference.
006.03 Initial 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.
006.04 List of Approved Methods for Class A Permits.
1. Gas
Chromatography
2. Enzymatic Alcohol
Dehydrogenase
3. Radiative Energy
Attenuation
006.05 Operating 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:
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.
006.05D
Ongoing 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.
006.06 Inspection, 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.
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