Neb. Admin. Code tit. 177 — Health/Laboratory Services

Chapter 1 Rules and Regulations Relating to Analyses for the Determination of the Alcohol Content in Blood or Breath

Neb. Admin. Code tit. 177, ch. 1 Rules and Regulations Relating to Analyses for the Determination of the Alcohol Content in Blood or Breath {#sec-177-nac-1 omnilex-key=us-ne-regs-official--title-177--177 NAC 1}

DIVISION OF PUBLIC HEALTH

001 DEFINITIONS

001.01 Alcohol means ethyl alcohol.

001.02 Alcohol analysis means the use of a chemical test to determine the concentration of alcohol per 100 milliliters of blood, or the concentration of alcohol per 210 liters of breath.

001.03 Analyst means a holder of a Class A, B, or C permit.

001.04 Breath means exhaled lung air that is used for alcohol analysis which contains a large portion of air from the alveolar region of the lungs where the exchange of gases between the blood and air occurs.

001.05 Breath testing means the analysis of breath for alcohol content.

001.06 Body fluid refers to blood or breath.

001.07 Categories of Permits.

001.07A Class A Permit is a permit to perform a chemical test to analyze a subject's blood for alcohol content by an approved laboratory method.

001.07B Class B Permit is a permit to perform a chemical test to analyze a subject's breath for alcohol content by an approved method.

001.07C Class C Permit is a permit to perform preliminary breath tests for alcohol content by an approved method.

001.08 Chemical test means an examination which measures the alcohol content in a chemical reaction, or chemical transformation such as infrared absorption.

001.09 Department means the Department of Health and Human Services, Division of Public Health.

001.10 DHHS means the Department of Health and Human Services.

001.11 Dry Gas Standard means a premixed, certified mixture of alcohol and nitrogen.

001.12 Into service means that an instrument is being placed for the first time at a testing site, not when it is returned from being repaired.

001.13 Instrument means an item of testing equipment used for performing chemical tests.

001.14 Laboratory method means a chemical analysis using laboratory procedures and instrumentation.

001.15 Maintenance officer means the person responsible for maintenance and calibration verification at a testing site.

001.16 Method means the name of the principle of analysis. The method may be a laboratory method.

001.17 mg/ml means milligrams per milliliter.

001.18 Test record means any results printed/transmitted/produced by an evidentiary breath testing device.

001.19 Refusal or deficient sample means the failure to provide a sufficient sample of body fluid to complete a blood or breath test or the refusal to submit to a chemical test of blood or breath.

001.20 Stoppered means any cork, plug, or other object used to close a bottle, drain, tube and so on, to prevent leakage of liquid or vapor.

001.21 Technique means a set of written instructions which describe the procedure, equipment, and equipment preventive maintenance necessary to obtain an accurate alcohol content test result.

001.22 Test means a chemical analysis to determine the presence of or quantification of alcohol.

001.23 Test run means the performance of test(s) which begin at a time and are carried to completion for a sample, or samples grouped in a consecutive manner.

001.24 Testing site means the physical location where a testing device(s) is located; and where testing is conducted.

001.25 Valid permit means an authorization issued by the Department to an individual to allow the holder of the permit to perform alcohol analysis. Permits are non-expiring. Permits issued under prior regulations are valid permits.

001.26 Valid test means an analysis performed according to methods approved by the Department by an individual possessing a valid permit.

001.27 Wet bath simulator solution means a premixed, certified ethyl alcohol and water solution.

002 REPORT OF ALCOHOL TEST RESULTS FOR MEDICO-LEGAL PURPOSES

002.01 Breath Test Results. Report of Breath Test Results of a test for alcohol content of breath shall be reported as thousandths of a gram of alcohol per 210 liters of breath on the checklist.

002.01A No digital result shall be reported on the checklist unless the device has received a sufficient breath sample and completely executes its prescribed program and prints a test record to indicate that the program has been completed.

002.01B Prescribed Program. When a test record indicates an incomplete or deficient sample, this indicates that the device has not completed its prescribed program. Such deficient sample does not constitute a completed test or sufficient sample of breath and would be considered to be a refusal. Such deficient sample does not constitute a completed test, but is scientifically probative up to the amount indicated by the testing device at the time that the breath testing procedure stopped.

002.01B1 Preliminary breath testing devices are not required to produce a printed test record. When a sufficient breath sample is provided, the results of a preliminary breath test may be reported as a digital readout or as a pass or fail.

002.01C The completed checklist as found in these rules and regulations shall be the official record of breath test results.

002.01D Record Requirements in Performance of Tests. The testing records must show adherence to the approved method, and techniques.

002.02 Blood Test Results. Results of a test of blood for alcohol content shall be reported in terms of thousandths of a gram of alcohol per 100 milliliters of blood.

003 PERMITS

003.01 Permit Issuance. The permit shall be issued by the Department, and shall state the class of permit, and the approved method. The Department shall keep record of all permits issued. The Department may re-issue a permit when a written request is received from the permit holder.

003.02 Application. The applications shall be Attachment 8, Attachment 9, or Attachment 10, attached and incorporated herein by reference.

003.03 Name Change. The Department may reissue a permit when a permit holder changes his or her name and a written request is received from the permit holder.

004 REVOCATION OF PERMITS

004.01 Class A, B, or C permits are nonexpiring permits. Class A, B, or C permits may be revoked by the Department whenever the Department determines a permit holder is in noncompliance with these rules and regulations.

005 BLOOD SPECIMEN COLLECTION AND PRESERVATION

005.01 Blood specimens shall be taken by personnel authorized by law. The antiseptic solution used shall be non-alcoholic.

005.02 Blood specimens shall be collected in clean containers/tubes and stoppered. The container/tube shall contain an anticoagulant-preservative substance.

005.03 Specimen containers shall be labeled and shall show the following information on the label: name of person tested, date and time of specimen collection, and initials of person collecting the specimen.

005.04 While not in transit to be tested, or while not under examination, all blood specimens shall be refrigerated as soon as practical.

006 CLASS A PERMITS

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 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.

007 CLASS B PERMITS

007.01 Application for Class B Permit.

007.01A Application for a Class B Permit shall be made on a form prescribed by the Department as shown in Attachment 9, attached and incorporated by reference.

007.01B The Class B permit applicant shall be trained and tested in the following areas:

1. The basic operation of the device and its proper use for evidentiary testing;
2. The applicant shall demonstrate the ability to properly operate the appropriate device;
3. Instruction may include physiology and pharmacology of alcohol as it pertains to driving, relevant legal matters, and court testimony.

007.01C To obtain a Class B permit, the applicant shall achieve at least 70% on a written examination from the Department.

007.02 Operating Rules for Class B Permit. To determine the alcohol content in breath, a Class B permit holder shall:

007.02A Ascertain that maintenance and calibration checks have been performed on devices prior to testing by reviewing the current 40-day maintenance and calibration checks performed on the testing device.

007.02B Use the appropriate checklist to record each test, and retain the test record produced by the instrument for each evidentiary test.

008 LIST OF APPROVED METHODS, BREATH TESTING INSTRUMENTS, CALIBRATION DEVICES, AND INTERNAL REFERENCE STANDARDS FOR CLASS B PERMIT HOLDERS

008.01 All evidentiary breath testing devices that have been evaluated and approved by the National Highway Traffic Safety Administration (NHTSA) and published on the Conforming Products Lists of Evidential Breath Measuring Devices are approved devices in the State of Nebraska for the purposes of this rule and for Drug and Alcohol Testing in the Workplace (Title 177 NAC 6). Prior to use of a NHTSA approved device for evidentiary breath tests conducted by law enforcement, the checklist technique and operating procedures for that device must be included in these regulations.

For Drug and Alcohol Testing in the Workplace (Title 177 NAC 6) testing, the operator is to conduct the test in accordance with the instructions provided by the manufacturer for the instrument. Although a checklist is not required, the test record produced by the instrument must be retained. The instrument is to be calibrated in conformance with the manufacturer’s instructions.

008.01A Approved evidentiary breath testing methods and instruments conducted by law enforcement, except preliminary breath testing devices, are listed below.

1. Intoxilyzer, all models
2. DataMaster, all models
3. Intoximeters, all models

008.01B Infrared absorption analysis using the Intoxilyzer and all instruments under the Intoxilyzer name. Checklist technique, as found in Attachment 16, attached and incorporated herein by reference, is approved for the Intoxilyzer.

008.01C Infrared absorption analysis using the Model DataMaster or Intoximeters and all instruments under the DataMaster or Intoximeters names. Checklist technique, as found in Attachment 16, is approved for the DataMaster or Intoximeters.

008.02 All calibration equipment that has been approved by the National Highway Traffic Safety Administration and published on the Conforming Product List of Calibrating Units for Breath Alcohol Testers is approved for calibration and verification of calibration of breath testing devices.

008.03 Approved reference standards and their use in calibration verification of evidentiary breath testing devices are described below and shall be used by a Class B permit holder with the applicable instrument.

008.03A DataMaster or Intoximeters with Internal Reference standard consisting of a known quartz filter used as a known standard specific to each instrument is an approved reference standard. Prior to placement into service at a testing site, the DataMaster or Intoximeters device with the internal quartz standard shall have the calibration checked with an alcohol wet bath simulator solution or dry gas standard.

008.03A1 Following the DataMaster or Intoximeters calibration check, an internal calibration analysis shall be performed. The results of this internal calibration check must be within +/- 5% of the target value.

008.03A1a If the internal check is not within +/- 5%, the instrument will abort the test and “Calibration Error” is displayed and printed on the test record.

008.03A2 Attachment 5, attached and incorporated herein by reference, shall be used for certifying the accuracy of the internal quartz standard used for calibration checks.

008.03B Intoxilyzer Internal Reference standard consisting of filters of predetermined values which correspond to the calibration setting of the instrument is an approved reference standard.

008.03B1 Prior to placement into service, the Intoxilyzer breath testing device with the internal reference standard(s) shall have the calibration checked with an alcohol wet bath simulator solution or dry gas standard.

008.03B2 Following the Intoxilyzer calibration check, an internal calibration analysis shall be performed. The result of this internal calibration check must indicate that all predetermined target values are within +/- 5% of the target values.

008.03B2a If any of the internal standards are not within +/- 5% of the target values, the instrument will abort the test and indicate the error by displaying and printing an error message.

008.03B3 Attachment 12, attached and incorporated herein by reference, shall be used for certifying the accuracy of the internal calibration reference standards.

008.04 Wet Bath Simulator Solutions or Dry Gas Standards. Testing device calibration and calibration verification shall be performed using either dry gas standards or wet bath simulator solutions as follows:

008.04A Certification. The wet bath simulator solution or dry gas standard must be accompanied by a certificate of analysis. The certificate of analysis must contain the following information:

1. Name of the company which prepared the solution;
2. Name of the person who tested the solution;
3. Solution identification;
4. Chemical analysis of the solution;
5. Expected breath instrument calibration check test result;
6. Name of the accreditation institution (ISO, NIST, etc.) for the testing laboratory; and
7. A notarized signature of the responsible individual (company president or testing operator, e.g.).

008.04B Wet bath simulator solutions can be used for 100 analyses when used with devices that use vapor recirculation.

008.04C Dry gas standards may be used until their date of expiration.

008.04D Wet bath simulator solutions and dry gas standards may be stored at ambient room temperature. It shall be stored in a tightly stoppered device or other tightly stoppered container. The useful life of a wet bath simulator solution is 24 months.

009 MAINTENANCE OFFICER

009.01 Each testing site shall have a maintenance officer(s) who is responsible for maintenance and calibration verification of the testing device(s). The maintenance officer shall:

009.01A Be a Class B permit holder.

009.01B Be familiar with the testing device as a result of consultation with a manufacturer representative or other individual knowledgeable about the use of the device.

009.01C Notify the Department of the name of the maintenance officer(s) for each site and the serial number of each unit for which the maintenance officer is responsible.

009.01D Perform scheduled maintenance procedures for all approved evidentiary breath testing devices. Check the general condition of the instrument within 40 days prior to an analysis. This includes inspection of all display and operation lights and verification of printer operation. The maintenance may include simple replacement of peripherals such as keyboards, hoses or printers, basic cleaning, etc.

009.01E Within 40 days prior to an analysis, the maintenance officer is to conduct the calibration verification in accordance with the instructions provided by the manufacturer for the instrument and section 010. Results must be recorded in the maintenance log.

010 CALIBRATION VERIFICATION . Calibration verification of evidentiary breath testing devices will be conducted by a maintenance officer every 40 days. It will consist of two verifications using different target values from wet bath simulator solutions, dry gas standards, or internal references.

010.01 When calibration verification checks are performed with certified wet bath simulator solutions, all approved evidentiary breath testing instruments shall be able to produce results within +/- 5% of the target value of the wet bath simulator solution.

010.02 When calibration verification checks are performed by means of approved internal standard(s), all approved evidentiary breath testing instruments shall be able to produce results within +/- 5% of the known target values of the standard(s). This tolerance shall be verified by the normal prescribed program and operation of the testing devices.

010.03 When calibration verification checks are performed with dry gas standards, all approved evidentiary breath testing instruments shall be able to produce results within +/- 5% of the target value of the dry gas standard after applying applicable altitude or topographic elevation correction factor supplied by the manufacturer. Such correction factor may be applied by the operator, the dry gas standard supplier, or by the instrument if pre-programmed.

010.04 If the instrument calibration cannot be verified to be accurate within the above cited limits, the instrument will be taken out of service and repairs made as set forth in section 011.

011 REPAIR OF CLASS B BREATH TESTING DEVICES

011.01 When inspection of a testing device reveals the need for repair which may affect the validity of the test and requires the attention of a manufacturer’s representative or an individual trained for repair, it shall be repaired by the appropriate repairman and a record of each repair will be retained at the testing site.

011.02 Repair of a testing device, as opposed to maintenance (009.01D), includes the removal of the malfunctioning part(s) and the installation of the repair part(s). The removal or installation of all parts or electronic boards shall be recorded.

011.03 Calibration verification procedures shall be performed on a testing device following its repair, before it is returned to service.

011.04 The records to be maintained for repair activities shall include the type of malfunction of a testing device, the nature of the repair, the date of the repair, and shall show the name of the person performing these activities or the name of the person's agency or business organization.

011.05 The repair records, or copies of the repair records, for a testing device shall be made available to the Department upon request.

012 CLASS C PERMITS

012.01 Qualifications For Class C Permit Holders. Permit holder qualifications to operate approved devices to perform preliminary breath tests are:

012.01A Have knowledge of calibration and use of the testing device.

012.01A1 Evidence of knowledge shall be a passing grade of at least 70% on a written examination which shall be taken by every applicant and successfully passed prior to issuance of a permit, be prepared and administered by the Department, and consist of questions regarding calibration and use of the testing device.

012.01B Have demonstrated ability and competence to the satisfaction of the Department by completing a two and one half hour class and the satisfactory performance of analyses on audit samples.

012.01B1 Unacceptable performance on audit samples is defined as an error in the analyses greater than +/- 0.010 of the target value.

012.01B2 A prospective permit holder shall be allowed two attempts to achieve acceptable results of audit samples.

012.02 Issuance of Class C Permit.

012.02A Application for a Class C Permit shall be made on Attachment 10, attached and incorporated herein by reference.

012.02B A Class C Permit is valid for all approved preliminary breath test instruments.

012.03 List of Approved Methods and Devices for Class C Permits. Fuel cell analysis is the approved method of analysis for the following preliminary breath testing devices, and the checklist technique as found in Attachment 4, attached and incorporated herein by reference, is approved for the following preliminary breath testing devices.

1. Alco-Sensor, all models
2. Intoxilyzer, all models that use fuel cell analysis
3. Lifeloc, all models that use fuel cell analysis

012.04 Maintenance and Repair of Preliminary Breath Testing Devices.

012.04A The periodic fuel cell replacement, recognized by inspection when it is not possible to adjust the calibration up to the desired value, shall be performed by a manufacturer's representative or person trained by manufacturer.

012.04B The periodic electrical battery replacement, recognized when the light display indicates a low battery, may be performed by a permit holder.

012.04C Repair of a testing device shall be performed by a manufacturer's representative or a person trained by the manufacturer.

012.04D Malfunctions of testing devices, maintenance, and repair occurrences shall be recorded and shall show the name of the agency or business organization performing these activities.

012.05 Calibration of Testing Devices. All preliminary breath test devices are to be calibrated, or calibration verified, within 30 days prior to testing, and a record kept of the activity.

013 BLOOD OR BREATH TESTS FOR FATALITY ACCIDENT REPORTS

013.01 Tests performed for purposes of accidents involving fatalities shall be performed by either a Class A permit holder or a Class B permit holder according to these rules and regulations.

013.02 The provisions of these rules and regulations apply to all samples and tests prescribed in Nebraska Revised Statutes sections 60-6,101 to 60-6,107 for determining alcohol content of blood in certain persons involved in fatality accidents.

014 BLOOD OR BREATH TESTS FOR BOATING WHILE INTOXICATED

014.01 Chemical tests performed for purposes of the determination of the alcohol content in blood or breath of any person operating any motorboat or vessel or manipulating any water skis, surfboard, or similar device while intoxicated shall be performed by either a Class A permit holder or a Class B permit holder, as authorized by Nebraska Revised Statutes Section 37-1254.

014.02 The provisions of these rules and regulations apply to all preliminary breath testing conducted pursuant to the provisions of Nebraska Revised Statutes Section 37-1254. Any violation of the provisions of Nebraska Revised Statutes Section 37-1254 shall be established by blood or breath tests conducted by either a Class A permit holder or a Class B permit holder with all provisions of this Rule, 177 NAC 1, pertaining to either a Class A or Class B permit applying thereto.

015 TRANSITION TO NEW RULES, VALID TESTS : Instruments may be maintained and tests may be administered in conformity with 177 NAC 1 for up to 40 days from the effective date of these amendments.

These Amended Regulations Replace Title 177, Chapter 1, Rules and Regulations Relating to Analyses for the Determination of the Alcohol Content in Blood or Breath, last effective date May 4, 2014.

History

• Effective 2016-06-19

Chapter 5 Fees for Department Laboratory Tests and Services

Neb. Admin. Code tit. 177, ch. 5 Fees for Department Laboratory Tests and Services {#sec-177-nac-5 omnilex-key=us-ne-regs-official--title-177--177 NAC 5}

TITLE 177 HEALTH/LABORATORY SERVICES

CHAPTER 5 FEES FOR DEPARTMENT LABORATORY TESTS AND SERVICES

001. SCOPE AND AUTHORITY . These regulations establish formulas for fees for laboratory tests and services and responsibility for payment pursuant to Nebraska Revised Statutes (Neb. Rev. Stat.) §§ 71-2619 to 71-2621, 71-5301, and 71-5306.

002. DEFINITIONS . Definitions set out in Neb. Rev. Stat. §§ 71-5301 and the following apply to this chapter:

002.01 CHAIN OF CUSTODY. The documentation and other activities done to ensure the identity of a sample and to ensure that no substantial change has taken place in the sample to make it misleading. It includes all those activities that protect the integrity of the sample.

002.02 ELECTIVE TEST. A drinking water sample test which is performed for a reason other than to meet the public water system testing requirements found in Title 179.

002.03 EQUIPMENT. Any tool, instrument, appliance, or utensil necessary to perform the task of analyzing laboratory samples which has a life expectancy greater than two years.

002.04 SAMPLE. A representative portion of any substance submitted to the laboratory for testing.

002.05 TEST. The application of prescribed procedures designed to identify or measure the microbiological, chemical, radiological, or physical characteristics of materials and substances.

003. COMPONENTS OF FEES IN THE FORMULAS . The following are the components used in determining fees.

003.01 COST OF LABOR. The cost of labor is equal to 3 times the cost of the average salary and benefits of Department laboratory employee(s) who conduct the analysis for the period of time required to complete the test. The multiplier is used to account for employee time spent on laboratory related tasks.

003.02 EQUIPMENT COST. Equipment cost is equal to the cost of the equipment divided by the life expectancy of the equipment plus the cost for maintenance and repairs.

003.03 MATERIAL COST. Material cost includes the costs for disposable equipment, reagents, and other items having a life expectancy of less than 2 years.

003.04 OVERHEAD COST. Overhead cost includes actual expenses not chargeable to a particular part of the work or product.

003.05 SAMPLE COLLECTION KIT COST. Sample collection kit cost is the cost associated with the container and chemicals for preservation of samples required to take samples relating to the testing of drinking water, environmental samples, and blood alcohol.

003.06 SHIPPING COST. Shipping cost includes all costs associated with the sample collection kits, mailing containers, sample collection forms and instructions, labor, cost of postage or transportation, and mailroom equipment and anything else necessary to carry out the function of shipping.

003.07 CHAIN OF CUSTODY COST. Chain of custody cost include all costs associated with the documentation and maintenance of samples.

004. FORMULAS AND METHODS FOR DETERMINING FEES . The following formulas and methods shall be used to establish fees for performing laboratory tests and services:

(A) The formula for shipping is Fee = Shipping Cost + Overhead;

(B) The formula for testing samples of blood for alcohol level is:

Fee = Labor Cost + Materials Cost + Equipment Cost + Overhead + Chain of Custody

Estimated Number of Tests

(C) The formula for testing routine drinking water samples is:

Fee = Labor Cost + Materials Cost + Equipment Cost + Overhead + Chain of Custody

Estimated Number of Tests

(D) The formula for testing environmental samples is:

Fee = Labor Cost + Materials Cost + Equipment Cost + Overhead + Chain of Custody

Estimated Number of Tests

(E) The fees for elective tests are determined using the formula for other similar samples.

(F) The fee for requests for tests not otherwise covered by this chapter will be the actual costs incurred by the Department.

(G) If the Department contracts with another laboratory to perform a test, the fee will be the contracted cost plus any related expenses the Department incurs.

(H) If a request is made to assign higher priority to testing specific samples, and the laboratory workload is rescheduled to accommodate this request, any additional cost for doing so will be added to the fee otherwise determined by this chapter.

005. RESPONSIBILITY FOR PAYMENT . Each person or entity submitting a sample for analysis shall identify who is responsible for paying the fee when requesting a test.

History

• Effective 2020-08-31

Chapter 6 Drug and Alcohol Testing in the Workplace

Neb. Admin. Code tit. 177, ch. 6 Drug and Alcohol Testing in the Workplace {#sec-177-nac-6 omnilex-key=us-ne-regs-official--title-177--177 NAC 6}

001 PRELIMINARY SCREENING WITH BREATH TESTING DEVICES .

001.01 A person is not required to hold a permit to perform preliminary breath tests for alcohol content in the workplace.

002 BREATH SAMPLE CONFIRMATION TESTING OF A POSITIVE FINDING OF ALCOHOL IN A PRELIMINARY SCREENING PROCEDURE .

002.01 All evidentiary breath testing devices that have been evaluated and approved by the National Highway Traffic Safety Administration (NHTSA) and published on the Conforming Products Lists of Evidential Breath Measuring Devices are approved devices in the State of Nebraska for Drug and Alcohol Testing in the Workplace. The instrument is to be calibrated in conformance with the manufacturer’s instructions. The operator is to conduct the test in accordance with the instructions provided by the manufacturer for the instrument. Although a checklist is not required, the test record card or tape produced by the instrument must be retained.

002.02 A positive result must be confirmed with a second breath sample or a blood sample. If the second sample is breath, the result must be within 20% of the original sample.

002.02A If the two breath tests do not agree within 20%, a blood test, as set forth in section 003, shall be performed. A blood test may be performed in lieu of the second breath test; if so, it is considered the final result, regardless of whether it agrees with the original breath test.

002.03 Breath sample confirming tests shall be preformed by a breath-testing-device operator. Breath Testing Device operators shall obtain a valid Class B permit for testing in the workplace as follows:

002.03A Application for a Class B Permit shall be made on a form prescribed by the Department as shown in Attachment 1, attached and incorporated by reference.

002.03B The Class B permit applicant shall attend a training session consisting of a minimum of six hours of instruction. The course shall include the method and technique of the testing device. It will include the basic operation of the device and its proper use for evidentiary testing. The applicant shall demonstrate the ability to properly operate the appropriate device.

002.03C To obtain a Class B permit, the applicant shall achieve at least 70% on an examination from the Department of Health and Human Services.

003 BLOOD SAMPLE CONFIRMATION TESTING OF POSITIVE FINDINGS OF ALCOHOL IN A PRELIMINARY SCREENING PROCEDURE .

003.01 Confirmatory alcohol testing on blood samples shall be performed in compliance with 177 NAC 1.

004 DRUG TESTING BY CONFIRMATION TESTING FOLLOWING A POSITIVE FINDING OF DRUGS IN A PRELIMINARY SCREENING PROCEDURE .

004.01 Confirmatory drug testing shall be performed in compliance with 177 NAC 7.

Approved by the Attorney General: December 3, 2009

Approved by the Governor: December 18, 2009

Filed with the Secretary of State: December 18, 2009

History

• Effective 2009-12-23

Chapter 7 Rules and Regulations Relating to Analyses for the Determination of the Drug Content in Urine While Driving Under the Influence of Drugs

Neb. Admin. Code tit. 177, ch. 7 Rules and Regulations Relating to Analyses for the Determination of the Drug Content in Urine While Driving Under the Influence of Drugs {#sec-177-nac-7 omnilex-key=us-ne-regs-official--title-177--177 NAC 7}

TITLE 177 HEALTH/LABORATORY SERVICES

CHAPTER 7 METHODS AND PERMITS FOR ANALYSES TO DETERMINE THE PRESENCE OF DRUGS

001. SCOPE AND AUTHORITY. These regulations govern the approval of methods and the issuance of permits for performing analyses to determine the presence of drugs as authorized by Nebraska Rules of the Road, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 60-601 to 60-6,383.

002. DEFINITIONS.

002.01 CLASS D PERMIT. A permit issued by the Department of the Health and Human Services to perform an analysis to determine the presence of drugs by an approved method.

002.02 METABOLITE. The specific substance produced when the human body metabolizes a drug as it passes through the body and is excreted in the urine.

002.03 VALIDATION. A process by which a newly developed, or laboratory developed method or technique is evaluated to determine its efficacy and reliability in the testing laboratory.

002.04 VERIFICATION. A process by which a method or technique that has been developed and used in the field, but is new to the testing laboratory, is evaluated to ensure its efficacy and reliability in the testing laboratory.

003. CLASS D PERMITS.

003.01 APPLICATION FORMS. Applications for initial permits, applications for additional method endorsement on an existing permit, and applications to replace lost permits shall be made on forms provided by the Department of Health and Human Services.

003.02 CLASS D PERMIT HOLDER QUALIFICATIONS. An applicant for a Class D Permit must:

(A) Be at least 19 years of age;

(B) Have completed a minimum of sixteen credit hours of academic work in chemistry, biochemistry, or combination of both from an accredited college or university;

(C) Provide documentation of education or training relating to the approved method or methods the applicant wishes to have endorsed on the applicant’s permit including:

(i) Theory of instrument operation;

(ii) Operating procedure of the instrument;

(iii) Calibration of the instrument; and

(iv) Maintenance of the instrument;

(D) Provide documentation of successful completion of a competency evaluation by providing copies of the results of sample testing or the graded performance from a recognized proficiency testing service. The competency evaluation may be conducted in house by an employer where the content of the samples to be tested is not known or readily available to the person being evaluated. The competency evaluation may also be conducted using a provider that is accredited to ISO/IEC 17043 conformity assessment standards by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC). For purposes of this chapter, satisfactory completion of a competency evaluation means obtaining the expected result of analysis on a sample and correctly writing a report communicating the results of the analysis. Competency evaluation documentation must be provided for each method the applicant wishes to have endorsed on the applicant’s permit;

(E) Be a United States Citizen or qualified alien under applicable law;

(F) Provide all additional information the Department may require;

(G) Disclose any criminal history or listing on the Department’s abuse and neglect central registry or the Nebraska State Patrol Sex Offender Registry; and

(H) Consent to a state-level criminal history background check and abuse and neglect central registry check.

003.03 CONTINUING REQUIREMENTS. A Class D Permit holder must:

(A) Report to the Department any change of address or change of employment within 30 days;

(B) Report to the Department any criminal conviction other than traffic infractions within 30 days; and

(C) Upon request, annually provide documentation of successful completion of a proficiency evaluation by providing copies of the results of sample testing or the graded performance from a recognized proficiency testing service. The proficiency evaluation may be conducted once every 2 years in house by an employer where the content of the samples to be tested is not known or readily available to the person being evaluated. The proficiency evaluation must be conducted once every 2 years using a provider that is accredited to ISO/IEC 17043 conformity assessment standards by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC). For purposes of this chapter, satisfactory completion of a proficiency evaluation means obtaining the expected result of analysis on a sample and correctly writing a report communicating the results of the analysis. Proficiency evaluation documentation must be provided for each method the applicant wishes to have endorsed on the applicant’s permit.

003.04 REVOCATION OR DENIAL OF A CLASS D PERMIT.

003.05 Class D Permits may be revoked or denied for the following reasons:

(A) Misrepresentation of material facts in procuring or attempting to procure a Class D Permit;

(B) Conviction of:

(i) A misdemeanor or felony under Nebraska law or federal law; or

(ii) A crime in any jurisdiction which, if committed within this state, would have constituted a misdemeanor or felony under Nebraska law in the last 10 years which has a rational connection with the fitness or capacity of the individual to hold a Class D Permit;

(C) Falsifying a report regarding the presence of drugs in a tested sample;

(D) Failure to have or maintain the requirements necessary to obtain a Class D Permit;

(E) For an applicant for an initial Class D Permit, failure to satisfactorily complete a competency evaluation as set forth in this chapter;

(F) For an existing permit holder’s, failure to satisfactorily complete a proficiency evaluation as set forth in this chapter with 2 consecutive failures contributed to the analyst’s fault; or

(G) Failure to comply with the requirements of this chapter.

004. METHODS.

004.01 METABOLITES. Approved methods for analyses to determine the presence of drugs also include analyses to determine the presence of metabolites produced when the human body metabolizes a drug as it passes through the body and is excreted in the urine. The presence of metabolites may be used to determine the presence of drugs.

004.02 INITIAL SCREEN. A Class D Permit holder may use an immunoassay or other technology to initially screen a specimen for the presence of drugs. An initial screen is not required, and the use or non-use of an initial screen does not affect the validity of an analysis performed by an approved method, as set forth in this chapter. Any screening results are provided for the information of the submitting agency and should not be used in court without further confirmatory testing.

004.03 APPROVED METHODS. The following methods are approved for performing analyses to determine the presence of drugs, as authorized by the Nebraska Rules of the Road, Neb. Rev. Stat. §§ 60-601 to 60-6,383:

(A) Analysis of urine for drug content by using a Gas Chromatograph/Mass Spectrometer, where the standard operating and analytical procedures implemented for use of the Gas Chromatograph/Mass Spectrometer have been validated or verified, as applicable by the laboratory in which the Class D Permit holder is performing the analysis;

(B) Analysis of urine for drug content by using Liquid Chromatography Mass Spectrometry, where the standard operating and analytical procedures implemented for use of Liquid Chromatography Mass Spectrometry have been validated or verified, as applicable by the laboratory in which the Class D Permit holder is performing the analysis; and

(C) Analysis of urine for drug content by using Liquid Chromatography Tandem Mass Spectrometry, where the standard operating and analytical procedures implemented for use of Liquid Chromatography Tandem Mass Spectrometry have been validated or verified, as applicable by the laboratory in which the Class D Permit holder is performing the analysis.

005. SPECIMEN COLLECTION AND PRESERVATION.

005.01 THE BODILY FLUID SPECIMEN.

(A) Collection of Specimen:

(i)If the specimen collected is urine, the collection of urine shall include saving a portion of an initial urination in a clean, dry, and capped sample container ;

(ii)All sample collection shall be in the presence of collection personnel designated by the law enforcement agency to ensure adulteration of the sample does not occur; and

(iii)All specimen containers shall be labeled and show the following information on the label: name of person tested, date and time of specimen collection, and initials of person supervising the collection of the specimen;

(B) Preservation of Specimen:

(i) Specimen containers, with collected body fluid , shall be sealed and refrigerated or frozen as soon as practical ; and

(ii) While not in transit to a site for testing, and while not under actual testing, all body fluid specimens shall be in secured refrigerated or frozen storage at eight degrees centigrade or colder; and

(C) Retention of specimen following testing:

(i) Any remaining specimen after testing shall be retained in a secured frozen storage as per individual agency policies.

006. STANDARD OPERATING AND ANALYTICAL PROCEDURE REQUIREMENTS.

006.01 OPERATING RULES. When a laboratory receives a bodily fluid specimen, it must do the following:

(A) Maintain the chain of custody for the body fluid sample;

(B) Document the status of all seals and labeling found on the body fluid specimen and associated packaging;

(C)Perform all tests using an approved method, and comply with the validated or verified standard operating and analytical procedures for the approved method;

(D)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:

(i) Have defined acceptance criteria for quality control data; and

(ii) Have defined acceptance criteria for positive identification of drugs and metabolites; and

(E) Seal and label the body fluid evidence prior to its release to the submitting agency for retention.

006.02 REQUIREMENTS FOR REPORTING RESULTS. The following must be made available, upon request, for the reported results of each tested specimen:

(A) Standard operating and analytical procedures were followed for analysis;

(B) Quality control data was evaluated and found to fall within the laboratory’s defined acceptance criteria;

(C) Analytical data was evaluated and fell within the laboratory’s defined positive identification acceptance criteria; and

(D) If screening only results are reported, then it must be clearly stated that the screening only results are not for use in prosecution without confirmation testing.

006.03 MAINTENANCE AND REPAIR OF INSTRUMENTS. The laboratory is responsible for maintenance and report of instruments.

(A)Maintenance shall be performed as prescribed in the laboratory’s standard operating and analytical procedures.

(B) All maintenance and repairs shall be performed by laboratory personnel or a vendor who has met the laboratory’s vendor approval requirements for the service being provided.

(C) The laboratory shall have procedure(s) for checking instrument performance after completion of repair or maintenance.

006.04 DOCUMENTATION REQUIREMENTS. The laboratory must record all malfunctions, maintenance, and repair activity of testing instruments. The documentation shall include:

(A) The name and business organization of person performing the activity;

(B) The date of activity;

(C) A description of the reason for the activity and the activity performed; and

(D) The result of the instrument check performed upon completion of the activity.

006.05 RECORD RETENTION. The Class D Permit holder must maintain the following records:

(A) The permit to perform analysis;

(B) Records of specimen receipts, tests performed, and results;

(C) The method and techniques, including the standard operating and analytical procedures, in use at the time of each respective specimen analysis;

(D) Validations and verifications of all methods and techniques used for analysis;

(E) Quality control results related to test runs of specimens;

(F) A current copy of these rules and regulations;

(G) The records of maintenance and repair performed on instruments as described in this chapter; and

(H) The results of performance evaluations, including any unacceptable results and the corrective actions associated with those results.

History

• Effective 2025-08-13