CHAPTER Saf-C 6300 BREATH ALCOHOL PROCEDURE USING THE
INTOXILYZER 5000 INSTRUMENT
REVISION NOTE:
Pursuant to 2003, 319:80, II, effective 1-1-04, rules He-P
2207 entitled “Breath Alcohol Procedure Using the Intoxilyzer 5000 Instrument”,
last filed by the Department of Health and Human Services under Document #6208,
effective 4-1-96, were transferred to the Department of Safety. The Department of Safety subsequently filed
Document #8064, effective 4-1-04, which readopted and renumbered as interim
rules in Saf-C 6300 most of the rules in the former He-P 2207.
The following rules in He-P 2207 were not included within
Document #8064 and are deemed by the Department of Safety to have expired on
4-1-04:
Definitions in He-P
2207.01(q) “Commissioner”; (s) “Division”, (w) “Forensic breath test supervisor
II”; (ab) “Laboratory”; and (ag) “Proficiency testing program”, and
He-P 2201.18 relative to a
proficiency testing program.
The rules in Document #8064 therefore replaced all prior
filings for rules in the former He-P 2207.
The filings of the Department of Health and Human Services or its
Division of Public Health Services affecting the former He-P 2207 include the
following documents:
#4744-a, effective 1-24-90
#6145, INTERIM, effective
12-21-95
#6208, effective 4-1-96
PART Saf-C 6301 DEFINITIONS
Saf-C 6301.01
"Accuracy" means the closeness of the test result to the true
or expected result.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.02 “Acetone” means dimethylketone, a volatile
chemical which can be found in the blood, urine or breath of a person under
certain metabolic conditions such as diabetes.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.03
"Alcohol" means ethanol,
ethyl alcohol or “intoxicating liquors” as defined in RSA 21:33.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.04
"Alveolar air" means that portion of a breath sample submitted
which is nearest in exchange between the lungs and the blood, the last portion
of a maximal expiration.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter
heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.05
"Analyte" means a compound for which an analysis is conducted.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter
heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.06
"Approval" means a statement of authorization signed by the commissioner.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.07
"Approved course of training" means a course of instruction
approved by the commissioner for proper operation of the breath test
instrument.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.08
"Approved instrument" means the Intoxilyzer 5000 .
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.09 “Approved method” means a procedure approved
by the commissioner in accordance with Saf-C 6305.04, to be followed in performing analyses of captured samples and
reporting results.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.10 “Blank
standard” means a silica gel tube containing no analyte.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.11
"Breath test instrument operator” means an individual who has
completed the eligibility requirements in Saf-C 6303.02.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter
heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.12
“Captured sample” means that sample of breath introduced into an
approved instrument and adsorbed onto a silica gel tube.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.13
“Captured sample bag” means a pre-numbered tamper resistant envelope in
which the subject’s captured samples are placed after completion of the breath
test.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.14
"Certification of breath test instrument operator" means a 12
month period in which a law enforcement officer, who meets the requirements of
Saf-C 6303.02, is authorized to conduct an analysis of a person's breath for
the purpose of determining its alcohol concentration.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.15
"Certification of equipment" means a 6 month interval in which the accuracy of a breath test instrument
has been verified by the forensic breath testing supervisor.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.16
"Certification of independent laboratory" means an interval in
which a laboratory that meets the
requirements of Saf-C 6305.01 is certified for the purpose of determining the
alcohol concentration of captured samples submitted for independent analysis.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.17 “
Commissioner” means the commissioner, department of safety or his/her designee.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.18 “Control” means a sample or solution of a
known concentration, similar to the sample which is analyzed, for quality
control purposes and not used in the calibration of a method.
Source. #8064,
INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter heading for
Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.19
“Director” means the forensic science laboratory director of the
division of state police, department of safety.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.20
"External standard reference" means a simulator test performed
on the approved instrument, using a
known alcohol/water solution, to verify
the accuracy of the approved instrument.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.21
"Field" means a police department or law enforcement agency
located within
Source. #8064,
INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter heading for
Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.22
"Forensic breath test supervisor" means an individual who is
authorized by the commissioner and has
met the requirements of Saf-C 6303.01.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.23
“Gas chromatography” means a method of analysis in which a sample is
injected into a stream of carrier gas moving through a column containing a
stationary phase composed of a liquid or particulate solid. The sample is then separated into its
component compounds according to their affinity for the stationary phase.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.24
"Headspace vapor" means a volume of gaseous sample above a
liquid in a closed container.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.25 "Internal standard" means a
substance which is added to the sample vial in a known concentration, which is
chemically similar to the analyte being determined and against which the
analyte can be measured.
Source. #8064,
INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter heading for
Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.26
"Internal standard reference" means an automatic check conducted by the approved instrument to determine
the readiness of that instrument to analyze a sample of breath.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.27
"Laboratory" means the forensic science laboratory or a
laboratory certified in accordance with Saf-C 6305.01.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter
heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.28
"Limits of detection" means the lowest and the highest levels
at which an analyte can be determined accurately without dilution of the
sample.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.29
"Modification" means an alteration to the approved instrument
affecting the accuracy or precision of the breath test.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.30
"Precision" means a measure of the agreement between replicate
tests.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.31
"Preventive maintenance check" means a scheduled or routine
maintenance performed on the approved instrument to ensure its continued
accuracy and precision.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.32 “Reagent blank” means a sample containing an
internal standard solution with no silica gel or analyte.
Source. #8064,
INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter heading for
Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.33
"Recertifying supervisor" means a certified breath test
instrument operator, authorized by
the director, who has met the eligibility requirements in Saf-C 6303.02.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.34
"Repairs" means an adjustment or replacement of parts or
components to return the equipment to proper operating condition.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.35
"Simulator" means a device used as an external standard
reference which is designed to produce a similar result as that obtained from
an actual breath sample, when operated under predefined conditions.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.36 “Standard” means a silica gel tube containing
a known concentration of analyte.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6301.37
"Subject sample" means a sample of alveolar air, given by a
person being tested to determine a breath alcohol concentration.
Source.
#8114, eff 7-14-04
PART Saf-C 6302 EQUIPMENT
Saf-C 6302.01 Approval
of Equipment.
(a) The commissioner
shall approve, the breath test instrument and simulator by make and model in accordance with (b) below. Pursuant to RSA 265:90, breath tests
conducted on an approved instrument to determine the alcohol concentration of
one's breath shall be offered for evidentiary purposes when performed by
certified personnel in accordance with procedures established in Saf-C 6302.02.
(b) The following
criteria shall be used by the commissioner for approval of the breath test
instrument:
(1) Breath samples collected for analysis shall be
alveolar in composition;
(2) The instrument shall be capable of analyzing a series of headspace vapor samples
from a simulator at known
concentrations;
(3) The instrument shall be capable of performing
an internal standard reference check;
(4) The instrument shall be capable of capturing
the subject's breath sample for delayed analysis; and
(5) The instrument shall be identified on the
“Conforming Products List” by the National Highway Traffic Safety
Administration as an “Evidential Breath Measurement Device.”
(c) Any approved instrument submitted to the
manufacturer for modification or repair shall be returned to the forensic
science laboratory upon completion of servicing and shall pass a preventive
maintenance check in accordance with Saf-C 6302.04 prior to returning the
approved instrument to the field.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6302.02 Sample
Collection.
(a) All breath
samples shall be alveolar air and shall be collected at the direction of the
certified operator.
(b) Immediately
prior to testing, the subject shall be observed by a certified operator for a
period of 20 minutes to ensure the integrity of the sample. Prior to the observation period, the operator
shall inform the subject not to place any material in his/her mouth. Should vomiting, regurgitation or belching
occur or any external material enter the mouth of the person to be examined, an
additional 20 minute wait period shall occur before testing. Should the certified operator determine that
the subject is not complying with the requirements of this paragraph or (d) below at any point during the testing
process, or the subject decides not to complete the sampling requirements in
(d), the certified operator shall
stop the test and record the test as a refusal pursuant to RSA 265:87.
(c) The certified operator
shall record and shall print out on the test record the identification of the
subject, the name of the certified
operator, and the date and time of the sample
collection. Identification of the approved instrument used to conduct the test shall include the make, model, serial number and field location of the approved instrument.
(d) A minimum of 2 subject samples shall be collected for
each complete breath test. If the
alcohol concentration readings of the first 2 samples do not agree within +/- 0.02 g/210L, a third subject
sample shall be collected.
(e) A reported value
shall be printed on the test record upon completion of the following:
(1) A 20 minute observation period before the
initial sample is taken;
(2) The identification of the subject, operator
and instrument;
(3) An ambient or room air check performed by the
approved instrument;
(4) An internal standard reference check
performed by the approved instrument;
(5) The satisfactory collection of a minimum 2 subject samples which agree within +/- 0.02 g/210L;
(6) The collection of a captured sample for each
satisfactory subject sample collected in accordance with (a), (b) and (d);
(7) An external standard reference check
performed by the approved instrument in accordance with (h) below; and
(8) The printout of test results and required
information.
(f) During the
testing process there shall be 2 reference
checks on the approved instrument.
(g) Prior to collection
of the first subject sample, the approved instrument shall be programmed to
perform an internal standard reference check at separate set points. If any one of the set points gives a reading
greater than +/-5% of the assigned value, the approved instrument shall be so
designed that it shall not allow a subject sample to be taken.
(h) Prior to
collection of the second subject
sample an external standard reference check shall be conducted via the external
reference port on the approved instrument.
The external standard reference check shall consist of a known
alcohol/water solution held at a constant temperature of 34oC +/-
0.2oC, whose vapor shall
give an alcohol concentration reading on the approved instrument of no less than 0.09 g/210L nor greater than 0.10
g/210L. The approved instrument shall be
so designed that a test cannot be completed if the external standard reference
result is not within the acceptable range.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6302.03 Reporting
of Findings.
(a) All completed
test results shall be printed on the breath test record and shall be reported
to the second decimal place without rounding.
(b) A reported value
shall be printed when a breath test is completed in accordance with Saf-C 6302.02(e) above;
(c) The reported
value shall be the lower of the 2 values which are within +/- 0.02 g/210L agreement.
(d) Breath test
results shall be expressed as grams
of alcohol per 210 liters of breath
(g/210L) pursuant to RSA 259:3-b.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter
heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6302.04 Preventive
Maintenance-Equipment.
(a) The forensic
breath testing supervisor shall conduct a preventive maintenance check on each
approved instrument 6 months after the
initial check and at 6 month intervals.
(b) A preventive
maintenance check pursuant to RSA 265:90, II shall include:
(1) Analysis of a series of simulated breath
tests at known alcohol
concentrations, to verify the
accuracy and precision of the approved
instrument which shall meet the following criteria:
a. For known alcohol concentrations less than
0.10 g/210L:
1. The accuracy of the readings shall deviate no
more than +/- 0.005 g/210L from the known alcohol concentration; and
2. The total precision range of the readings
shall not exceed +/- 0.005g/210L from the target value; and
b. For known alcohol concentrations equal to or
greater than 0.10 g/210L:
1. The accuracy of the readings shall be within
+/- 5% of the known alcohol concentration; and
2. The total precision range of the readings
shall not exceed 5% of the target value;
(2) Verification of the approved instrument's ability to detect and
correct for acetone;
(3) Collection of captured samples at known
alcohol concentrations to verify the accuracy of the captured sample method
which shall meet the following criteria:
a. For infrared values less than 0.10 g/210L,
results shall agree within 0.01 g/210L of the infrared value; and
b. For infrared values equal to or greater than
0.10 g/210L, results shall agree within 10% of the infrared value;
(4) Performance of routine
maintenance on the approved instrument and simulator as necessary to maintain
proper analytical functions; and
(5) Documentation of maintenance performed on
each approved instrument and simulator at the time of service.
(c) The forensic breath testing supervisor shall
not certify the accuracy and
precision of the instrument until the requirements in (b) (1) - (5) above are completed.
(d) The forensic
breath testing supervisor shall certify the accuracy and precision of the
approved instrument by signing and dating the preventive maintenance check
form, pursuant to RSA 265:90, II.
(e) The preventive
maintenance check form shall specify the following:
(1) The approved instrument and simulator by
make, model, and serial number;
(2) The field location of the equipment;
(3) The date of certification and expiration; and
(4) That he/she has found the approved instrument
and simulator to be in proper working order and that the equipment meets the
preventive maintenance requirements as outlined in (b) above and RSA 265:90, II.
(f) Repairs
performed on the approved instrument shall be documented and kept on file at
the forensic science laboratory. The
approved instrument shall not be
required to pass a preventive maintenance check if the repair does not affect the accuracy or precision of the breath
test.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
PART Saf-C 6303 QUALIFICATIONS OF INDIVIDUALS CONDUCTING
TESTS
Saf-C 6303.01 Forensic
Breath Testing Supervisor.
(a) Pursuant to RSA
265:85, V, the commissioner shall designate
a forensic breath testing supervisor as competent and qualified to
conduct such breath tests.
(b) To be considered
for designation as a forensic breath test supervisor, an applicant shall meet
the following requirements:
(1) A forensic breath testing supervisor shall
meet the minimum qualifications under division of personnel position
classification requirements as a laboratory scientist, a criminalist or a toxicologist;
and
(2) Complete the manufacturer's equipment
maintenance course for the approved instrument.
(c) Upon designation
by the commissioner, the forensic breath testing supervisor shall perform the following duties:
(1) Perform preventive maintenance on the
approved instrument;
(2) Certify the accuracy and precision of the approved instrument as required in Saf-C 6302.04
(3) Train and recertify breath test instrument
operators and recertifying supervisors;
(4) Inspect laboratories for purposes of Saf-C
6302.08; and
(5) Evaluate new breath test instruments, as
necessary, following the criteria for approval in accordance with Saf-C
6302.01(b)
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6303.02 Breath
Test Instrument Operator/Recertifying Supervisor.
(a) Personnel
certified by the commissioner, pursuant to RSA 265:85, V, shall be designated as a breath test
instrument operator or as a recertifying supervisor.
(b) Criteria for
breath test instrument operators and recertifying supervisors shall be as
follows:
(1) To be eligible for training as an operator of
the approved instrument, for purposes of RSA 265:84, RSA 215-A:11-a or RSA 270:49,
the applicant shall be currently employed as a law enforcement official within
the state of New Hampshire; and
(2) To be eligible as a recertifying supervisor:
a.
The applicant shall meet the eligibility requirements in (1) above;
b.
The applicant shall have taken and passed an approved course of training
as outlined in (h) below;
c.
The applicant shall be currently certified as a breath test instrument
operator;
d. The applicant shall have experience in
conducting actual breath tests by:
1.
Maintaining their certification in accordance with (k) below for a
period of not less than one year; and
2.
Conducting a minimum of 10 subject tests in accordance with Saf-C
6302.02 during one calendar year; and
e.
The applicant shall be approved by the commissioner.
(c) A breath test
instrument operator who has met the eligibility requirements of (b) above and has
passed the approved course of training as outlined in (h) below shall be
approved by the commissioner to
conduct breath tests pursuant to RSA 265:85, RSA 215-A:11-d or RSA 270:52.
(d) A recertifying
supervisor who has met the eligibility requirements of (b)(2) above shall perform the following duties:
(1) Conduct
breath tests pursuant to RSA 265:85, RSA
215-A:11-d or RSA 270:52;
(2)
Recertify breath test instrument operators within their own agency in
accordance with (j) below; and
(3) Assist
the forensic breath testing supervisor in the training of breath test
instrument operators;
(e) Recertifying
supervisors shall not recertify equipment.
(f) Applicants shall
meet the eligibility requirements in (b) above
and have completed a course of training provided by the
division covering the topics outlined in (h) below. A certificate shall be issued to the operator
by the agency sponsoring the course of training. This certificate of training shall be
submitted to the commissioner when applying
for certification as a breath test instrument operator.
(g) A comprehensive
practical and written examination shall be developed and administered by the
forensic breath testing supervisor at the completion of the course.
(h) The exam required
in accordance with (g) shall cover the following subject matter:
(1) The value and purpose of breath alcohol testing;
(2) The
physiological action of alcohol on the human body;
(3) The
pharmacology and toxicology of alcohol;
(4) The methods
of alcohol analysis and theory of breath testing;
(5) The instruments and procedures for breath
testing;
(6)
Laboratory practice and demonstration of competency by:
a.
Using proper technique in collecting and capturing a sample;
b.
Obtaining accurate results; and
c.
Following established operating and reporting procedures; and
(7) Legal
procedures and decisions affecting breath testing.
(i) A breath test
operator or recertifying supervisor certification shall be valid for a period
of 12 months from date of issue unless terminated or revoked.
(j) A certified breath test instrument
operator shall renew his/her certification prior to its expiration through:
(1) Demonstration
of competence in performing an analysis under the supervision of a forensic breath testing supervisor or
recertifying supervisor by:
a. Using proper
technique in collecting and capturing a
sample;
b.
Obtaining accurate results; and
c. Following established operating and reporting
procedures; and
(2)
Completion of a review course
provided by the division which shall include:
a.
Instrument operating and sampling technique;
b.
Analysis and reporting procedures; and
c.
Procedural changes and legal decisions affecting breath testing.
(k) A certified
recertifying supervisor shall renew his/her certification prior to its
expiration through:
(1)
Demonstration of competence in performing an analysis under the supervision
of a forensic breath testing supervisor by:
a. Using proper
technique in collecting a sample;
b.
Obtaining accurate results; and
c.
Following established operating and
reporting procedures; and
(2)
Completion of a review course provided by the division which shall
include:
a.
Instrument operating and sampling technique;
b.
Analysis and reporting procedures; and
c.
Procedural changes and legal decisions affecting breath testing;
(l) Reinstatement of
breath test instrument operators and recertifying supervisors shall be as
follows:
(1) A breath
test instrument operator's certification shall be reinstated by the forensic
breath testing supervisor or
recertifying supervisor if he/she meets the requirements of (j) above within
one year from the date of expiration; and
(2) A
recertifying supervisor's certification shall be reinstated by the forensic
breath testing supervisor if he/she
meets the requirements of (k) above within one year from the date of
expiration.
(m) A breath test instrument operator's or
recertifying supervisor's certification shall remain valid unless expired or
revoked after notice and opportunity for a hearing for the following reasons:
(1) Failure
to follow the operating procedure
for the approved instrument in accordance with Saf-C 6302.02(e);
(2) Failure
to follow the procedure for reporting and keeping of records;
(3) Failure
to renew certification within a 12 month period prior to expiration;
(4) Termination
of employment as a law enforcement official at any time during the 12 month
certification period, except for those individuals transferring from one law
enforcement agency to another within the State of New Hampshire; and
(5) Failure
to become reinstated after a period of one year from expiration of their last
certification.
(n) To become certified again, the former operator or recertifying supervisor
shall attend and complete an
approved course of training as described in
(h) above .
(o) A breath test
instrument operator or recertifying supervisor's certification shall be revoked
upon recommendation by the forensic breath testing supervisor in
accordance with (m)(1) and (2) above.
Notification of this revocation shall be forwarded to the breath testing
operator or recertifying supervisor by the commissioner by certified mail.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
PART Saf-C 6304 BREATH ALCOHOL SAMPLES
Saf-C 6304.01 Preservation
of Breath Alcohol Sample.
(a) When a subject
submits to a breath test on an approved instrument to determine his/her alcohol
concentration, pursuant to RSA 265:84, RSA
215-A:11-a or RSA
270:49, a captured sample of their breath shall be collected by the
certified breath test instrument operator.
(b) The certified
operator shall identify each captured sample of breath collected in accordance
with Saf-C 6302.02 by the following:
(1) The lot number of the tube;
(2) The name
of the individual tested;
(3) The date
of collection; and
(4) The
number in the sequence of samples collected.
(c) The captured samples
of breath shall be placed in a captured sample bag along with a copy of the subject's test record.
(d) The certified
operator shall record on the outside
of the captured sample bag:
(1) The
subject's name; and
(2) The date
the captured samples were collected.
(e) Each subject who
submits to a breath test and successfully completes the requirements of Saf-C
6302.02(e) shall be given the captured samples of his/her breath at the
completion of the test.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
PART 6305 CERTIFICATION OF INDEPENDENT LABORATORY
Saf-C 6305.01 Laboratory Certification, Independent
Analysis.
(a) Any laboratory
that performs an analysis of a captured sample to determine its alcohol
concentration pursuant to RSA 265:86, RSA 270:53 or RSA 215-A:11-e, shall be
certified by the commissioner pursuant to RSA 265:85, V.
(b) A laboratory
seeking certification shall submit a completed application to the commissioner
containing the following:
(1) The name
of the laboratory;
(2) The
address where the testing will be conducted;
(3) The telephone
number of the laboratory;
(4) The name
of the laboratory director;
(5) A list
of personnel who will be conducting the analyses;
(6)
Documentation of the scientific training and experience required in
accordance with Saf-C 6305.02 of the laboratory director and personnel who will
be conducting the analyses; and
(7)
Submission of a detailed written method to be used to analyze captured
samples in accordance with Saf-C
6305.04 which shall include the
following areas:
a. Principle
of the method;
b.
Sample requirements;
c.
Reagents, standards, and controls to be used in the method;
d.
Supplies to be used in the
method;
e.
Instrumentation to be used in the method;
f.
Calibration protocol;
g. Step
by step directions;
h.
Calculations;
i.
Frequency of analysis of blanks, standards, controls and samples;
j.
Accuracy and precision requirements of blanks, standards and controls;
k.
Precision requirements of the captured sample replicates;
l.
Corrective action to be taken if any of the accuracy and precision
requirements of (j) or (k) above are exceeded;
m.
Limits of detection;
n.
Limitations of the method such as interfering substances;
o.
Reporting of results;
p.
References; and
q.
Date of submission to the division.
(c) Applications
shall be approved in accordance with RSA 541-A:29 when the following conditions
are met:
(1)
Submission of a completed application in accordance with (b) above; and
(2) Approval of the method of analysis in
compliance with Saf-C 6305.04.
(d) A laboratory
requesting certification shall :
(1) Be
subject to inspection by forensic science laboratory personnel prior to initial
certification; and
(2) Be
subject to annual reinspection by forensic science laboratory personnel; and
(3) Grant
access for reinspection at any time during the certification period.
(e) The inspection
shall include verification of:
(1) Location
of equipment;
(2) Documentation of adherence to the method of
analysis as submitted with the application in accordance with (b) above;
(3)
Documentation of compliance with a quality assurance program in
accordance with Saf-C 6305.06; and
(4)
Reporting of results in accordance with Saf-C 6305.07 and Saf-C 6305.08.
(f) Certificates
shall be issued by the commissioner to laboratories completing the requirements
of this section for a period of 12
months from date of issue.
(g) The certificate
shall specify the following:
(1) The name
and location of the certified laboratory;
(2) The name
of the laboratory director;
(3) The
dates of the certification period; and
(4) That certification shall be subject to continued compliance with
Saf-C 6305.08 and Saf-C 6305.11.
(h) Denial of an
application shall be based upon the laboratory’s failure to meet the
requirements of this section. The
commissioner shall notify a laboratory of a denial in writing by certified
mail, return receipt requested.
(i) The commissioner
shall maintain a list of laboratories certified to perform analyses of captured
sample of breath for alcohol concentration.
This list shall be available to anyone upon written or verbal request.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.02 Independent
Laboratory Personnel.
(a) The laboratory director
and personnel shall meet or exceed the minimum qualifications under division of
personnel position classification requirements as a laboratory scientist,
criminalist or toxicologist.
(b) The laboratory
director shall verify the scientific education and experience of laboratory
personnel who perform analyses of captured samples in accordance with this
chapter.
(c) The laboratory
director shall notify the commissioner in writing within 10 days of any change in personnel who perform the analyses
of captured samples in accordance
with Saf-C 6305.01 and Saf-C 6305.04.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.03 Captured
Sample Receipt and Handling.
(a) Captured samples
of breath received by an independent laboratory certified to perform analyses
pursuant to RSA 265:86, RSA 270:53 or RSA 215-A:11-e shall be recorded in a
log.
(b) The log entries
shall include:
(1) The
captured sample bag serial number;
(2) The date
and time of receipt;
(3) The name
of the person submitting the captured sample or type of carrier transport used
to deliver the captured sample;
(4) The name
of the person receiving the captured sample; and
(5) A
comment area to record any problems with the captured sample bag at the time of
receipt.
(c) All logged
samples shall be secured to protect the integrity of the samples as received
until the time of analysis.
(d) The captured
sample bag shall be kept on file
from the time of opening until the subject’s case is disposed.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.04 Method
of Analysis of Captured Samples-Independent Laboratories.
(a) An independent
laboratory shall only use a method as specified in Saf-C 6305.01(b)(7) above in their application
to the commissioner.
(b) The method shall
utilize gas chromatography.
(c) The operating
conditions for the gas chromatograph shall include:
(1) A column
capable of separating alcohol from other volatile organic compounds;
(2) An oven
with temperature control;
(3) A
detector which responds to alcohol;
(4) A
carrier gas, inert to organic compounds, to transport the specimen through the
column; and
(5) A data integration
system capable of generating a printout of a chromatogram.
(d) An internal
standard shall be used in the analysis of all samples.
(e) Prior to each
day’s analysis of captured samples, the laboratory shall calibrate a method or verify
a previously calibrated method through
analysis of the following:
(1)
Standards prepared with the same type and amount of trapping material as
utilized to collect a captured sample of breath;
(2)
Standards prepared on the same series of approved instrument as used in
the original collecting procedure;
(3) A
minimum of 2 different levels of
standards;
(4) A blank
standard; and
(5) A
reagent blank.
(f) Analysis of
captured samples of breath shall be conducted in the following manner:
(1) The
captured sample bag shall be logged
in accordance with Saf-C 6305.03(b);
(2) The
captured sample shall be removed from the bag, inspected for any irregularities
and labeled for identification;
(3) Analysis
shall be performed on the captured sample which corresponds to the reported
value as determined in Saf-C 6302.03; and
(4) The
captured sample identified in (3) above shall be analyzed in duplicate.
Source. #8064,
INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter heading for
Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.05 Recording
of Analytical Data.
(a) All analytical
data shall be recorded in a breath alcohol run log including:
(1) The date
of analysis;
(2) The
target values and results of all blanks, standards and controls;
(3) The
results of the analyses of the subject’s captured sample identified as the
reported value in accordance with Saf-C 6302.04
(4) The lot
numbers of solutions used; and
(5) Any
problems which occurred during the analyses.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at chapter
heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.06 Quality
Assurance.
(a) An independent
laboratory shall have and implement a quality assurance plan to include, but
not be limited to documentation of the following categories:
(1) Equipment maintenance and repair;
(2) Quality
control; and
(3)
Analytical problems .
(b) All preventive
maintenance and repairs performed on the analytical equipment shall be
documented in a preventive maintenance log including:
(1) The date
of the maintenance or repair;
(2) The
action taken; and
(3) The name
of the person performing the action.
(c) All independent
laboratories shall maintain a record of quality control to assure adherence to their
approved method as outlined in Saf-C 6305.04.
Records of quality control shall be readily available for review upon
request. Records shall be kept on file
for not less than 5 years.
(d) Results shall
not be reported when chromatography interference occurs. Interference shall be deemed to occur when
the chromatographic peaks corresponding to the analytes are not separate and
distinct. The use of an alternative
chromatographic method may be employed as long as all other analyses in the run
are reported using the same alternative method.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.07 Reporting
of Findings.
(a) Results of
captured samples analyzed in accordance with Saf-C 6305.04 shall be recorded in
the run log.
(b) The reported
value of a captured sample shall be determined by:
(1) Taking
the lower of the 2 duplicate
results; and
(2) Truncating
the result determined in (1) to the second decimal place.
(c) The reported
value determined in (b) shall be expressed as grams of alcohol per 210 liters
of breath (g/210L), pursuant to RSA 259:3-b.
(d) The deviation
between the reported value of the approved instrument and the independent
laboratory’s reported value shall be derived by subtracting the independent
laboratory’s reported value determined in (b) from the reported value of the
approved instrument.
(e) The deviation
determined in (d) shall be expressed
as grams of alcohol per 210 liters of breath (g/210L).
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.08 Captured
Sample Analysis Report.
(a) The report of
the analysis of a captured sample tube performed by an independent laboratory
pursuant to RSA 265:86; RSA 270:53, RSA 215-A:11-e shall include:
(1) The name
of the laboratory;
(2) The date
of the report;
(3) The name
of the subject;
(4) The name
and address of the person requesting the analysis;
(5) The
serial number of the captured sample bag;
(6) The date
and time the bag was received;
(7) The name
of the person submitting the captured sample bag or the type of carrier
transport used to deliver the captured sample;
(8) A
notation to indicate any evidence of physical alteration to the captured sample
bag or its contents;
(9) The serial
number of the approved instrument from which the breath sample was captured;
(10) The
subject’s reported value identified on the printout from the approved
instrument in accordance with Saf-C 6302.04;
(11) The
number of the captured sample tube analyzed corresponding to the reported value
identified in (10) above;
(12) The
results of the captured sample analyzed in duplicate in accordance with Saf-C
6305.04(f) (3) and (4);
(13) The independent
laboratory’s reported value as determined in accordance with Saf-C 6305.07(b);
(14) The
deviation between the reported value for the approved instrument and the
independent laboratory’s reported value as determined in accordance with Saf-C 6305.07(d);
(15) The
date the analysis was completed;
(16) The
name of the person conducting the analysis; and
(17) A
statement that the analysis was conducted in accordance with Saf-C
6305.03-08and the independent laboratory’s approved procedure.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.09 Interpretation
of Results.
(a) Captured samples
of breath collected in accordance with Saf-C 6302.02(e) and Saf-C 6304.01 and
analyzed by an independent laboratory in accordance with Saf-C 6305.03-08 shall
be used to corroborate the reported value obtained by the approved instrument.
(b) The result of
the breath test shall be considered to be
corroborated when the reported value of the approved instrument is within the deviation limits for the
alcohol concentration levels outlined below:
(1) For alcohol
concentrations less than 0.05 g/210L and the deviation does not exceed
0.01g/210L;
(2) For
alcohol concentrations equal to 0.05 g/210L but less than 0.10 g/210L and the
deviation does not exceed 0.02g/210L;
(3) For
alcohol concentrations equal to 0.10 g/210L but less than 0.15 g/210L and the
deviation does not exceed 0.03g/210L;
(4) For
alcohol concentrations equal to 0.15 g/210L but less than 0.20 g/210L and the
deviation does not exceed 0.04g/210L; and
(5) For
alcohol concentrations equal to or greater than 0.20 g/210L and the deviation
does not exceed 0.05g/210L.
(c) When the result
of the breath test is not corroborated in (b) above, further evaluation shall
be required in order to determine the weight to be given to the reported value
of either the approved instrument or the independent laboratory.
(d) Pursuant to RSA
265:90, the evaluation of results shall include a review of the following
materials provided by:
(1) The
arresting officer or certified operator to include:
a. A
copy of the certification required by RSA 265:85, III from the operator who
performed the test;
b. A
copy of the preventive maintenance check form completed in accordance with
Saf-C 6302.04and dated prior to the subject’s test;
c. A
copy of the documentation of any
repairs performed on the approved instrument within the certification period
encompassing the subject’s test; and
d. A
copy of the breath test printout showing the completed test; and
(2) The
independent laboratory to include:
a. A
copy of the independent laboratory’s certification as required by RSA 265:85,V
for the period encompassing the date of analysis;
b. A
copy of the captured sample analysis report;
c. A
copy of the run log for the day the subject’s captured sample was analyzed;
d.
Copies of the gas chromatograph instrument printouts of the subject’s
captured sample results which correspond to the reported value obtained by the
approved instrument;
e.
Copies of all the gas chromatograph instrument printouts of the blanks,
standards and controls analyzed on the day the captured sample was analyzed;
and
f.
Documentation of any repairs or preventive maintenance performed on the gas
chromatograph instrument within a 2 month period before and after the analysis
of the subject’s captured sample.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.10 Statistics.
(a) Laboratories
certified to perform independent analyses of captured samples of breath shall
submit a monthly summary of their results to the forensic science
laboratory. The summary shall be
submitted no later than 10 working
days after the end of each month.
(b) The summary
shall consist of:
(1) The
approved instrument serial number;
(2) The date
of the breath test and the reported value; and
(3) The
independent laboratory’s reported value determined in accordance with Saf-C
6305.07.
(c) The summary
information shall be submitted in one of the following formats:
(1) Written
on 8.5 inch by 11 inch paper;
(2) Via
e-mail with an attached Microsoft Excel, Word or ASCII file.
(d) The summary data
shall be used by the forensic
science laboratory to monitor the performance of the independent laboratory and
the approved instruments to ensure the accuracy of the testing program.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.11 Renewal
of Independent Laboratory Certification.
(a) Applications for
renewal of certification shall be submitted to the commissioner no later than 30 days prior to
expiration and shall be subject to the provisions of RSA 541-A:30, I.
(b) The application
renewal procedure shall be as set forth in Saf-C 6305.01
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.12 Denial,
Suspension or Revocation of Certification.
(a) The
commissioner, after notice and opportunity for a hearing, shall deny, refuse to renew or suspend for a period of 60 days,
the certification of a laboratory for any of the following causes:
(1)
Fraudulent application or renewal of laboratory certification;
(2) Dishonest
reporting such as falsifying records;
(3) Failure
to report results in compliance with Saf-C 6305.08;
(4)
Permitting a person to perform analyses and report results who is not
listed with the commissioner, in accordance with Saf-C 6305.01 (b)(5); and
(5) Failure
to submit monthly statistical reports in accordance with Saf-C 6305.10.
(b) The commissioner shall revoke, after notice and an
opportunity for a hearing, a laboratory’s certification if after a suspension, the
violation(s) has not been corrected.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.13 Reinstatement
of Laboratory Certification
(a) A laboratory
requesting reinstatement shall submit a letter to the commissioner, outlining
the corrective measures taken to improve the laboratory’s performance.
(b) The commissioner shall respond to a laboratory request for
reinstatement in accordance with RSA 541-A:29.
Notice of reinstatement or denial shall be made in writing, by certified
mail, return receipt requested.
(c) If the
commissioner grants reinstatement
and the laboratory’s certification has expired during the period of revocation
or suspension, the laboratory shall reapply in accordance with Saf-C 6305.01.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
Saf-C 6305.14 Procedure
for Hearing. All hearings conducted
by the commissioner shall be in accordance with the department of safety's
general rules for procedure for hearings, Saf-C 200.
Source.
#8064, INTERIM, eff 4-1-04, EXPIRES: 9-28-04 (See Revision Note at
chapter heading for Saf-C 6300); ss by #8114, eff 7-14-04
APPENDIX
|
Rule |
|
|
|
|
|
Saf-C 6301 |
RSA 541-A:1, XV |
|
Saf-C 6302.01(a) |
RSA 265:85, V &
RSA 265:90, IV |
|
Saf-C 6302.01(b) -
6302.03 |
RSA 265:85, V |
|
Saf-C 6302.04(a)-(d) |
RSA 265:85, V(f)
& RSA 265:90, II |
|
Saf-C 6302.04(e) |
RSA 541-A:16,
I(b)(1) |
|
Saf-C 6302.04(f) |
RSA 265:85, V(f) |
|
Saf-C 6303 |
RSA 265:85, V(b) |
|
Saf-C 6304 |
RSA 265:85, V(c)
& RSA 265:86, II |
|
Saf-C 6305.01(a) |
RSA 265:85, V(e) |
|
Saf-C 6305.01(b) |
RSA 541-A:16,
I(b)(1) & RSA 265:85, V(e) |
|
Saf-C 6305.01(c) |
RSA 541-A:29 &
RSA 265:85, V(e) |
|
Saf-C 6305.01(d)-(i) |
RSA 265:85, V(e) |
|
Saf-C 6305.02 |
RSA 265:85, V(b)
& (e) |
|
Saf-C 6305.03 |
RSA 265:85, V(c)
& (e) |
|
Saf-C 6305.04 -
6305.08 |
RSA 265:85, V(a)
& (e) |
|
Saf-C 6305.09(a)-(c) |
RSA 265:85, V(a)
& (e) |
|
Saf-C
6305.09(d)(1)a. |
RSA 265:85, V(d)
& RSA 265:85, III |
|
Saf-C
6305.09(d)(1)b. |
RSA 265:85, V(d)
& RSA 265:90, II |
|
Saf-C
6305.09(d)(1)c. - Saf-C 6305.09(d)(2) |
RSA 265:85, V(d) |
|
Saf-C 6305.10 -
Saf-C 6305.14 |
RSA 265:85, V(e)
& (f) |
|
|
|