[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR26.91]
[Page 449-463]
TITLE 10--ENERGY
CHAPTER I--NUCLEAR REGULATORY COMMISSION
PART 26--FITNESS FOR DUTY PROGRAMS--Table of Contents
Sec. 26.91 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act. For purposes of section 223,
all the regulations in part 26 are issued under one or more of sections
161b, 161i, or 161o, except for the sections listed in paragraph (b) of
this section.
(b) The regulations in part 26 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 26.1, 26.2, 26.3, 26.4, 26.6, 26.8, 26.90, and 26.91.
[57 FR 55072, Nov. 24, 1992]
Appendix A to Part 26--Guidelines for Drug and Alcohol Testing Programs
Subpart A--General
1.1 Applicability
1.2 Definitions
Subpart B--Scientific and Technical Requirements
2.1 The Substances
2.2 General Administration of Testing
2.3 Preventing Subversion of Testing
2.4 Specimen Collection Procedures
2.5 HHS-Certified Laboratory Personnel
2.6 Licensee Testing Facility Personnel
2.7 Laboratory and Testing Facility Analysis Procedures
2.8 Quality Assurance and Quality Control
2.9 Reporting and Review of Results
Subpart C--Employee Protection
3.1 Protection of Employee Records
3.2 Individual Access to Test and Laboratory Certification Results
Subpart D--Certification of Laboratories Engaged in Chemical Testing
4.1 Use of DHHS-Certified Laboratories
Subpart A--General
1.1 Applicability
(1) These guidelines apply to licensees authorized to operate
nuclear power reactors and licensees who are authorized to possess, use,
or transport formula quantities of strategic special nuclear material
(SSNM).
(2) Licensees may set more stringent cut-off levels than specified
herein or test for substances other than specified herein and shall
inform the Commission of such deviation within 60 days of implementing
such change. Licensees may not deviate from the provisions of these
guidelines without the written approval of the Commission.
(3) Only laboratories which are HHS-certified are authorized to
perform urine drug testing for NRC licensees, vendors, and licensee
contractors.
1.2 Definitions
For the purposes of this part, the following definitions apply:
[[Page 450]]
``Aliquot.'' A portion of a specimen used for testing.
``BAC.'' Blood alcohol concentration (BAC), which can be measured
directly from blood or derived from a measure of the concentration of
alcohol in a breath specimen, is a measure of the mass of alcohol in a
volume of blood such that an individual with 100 mg of alcohol per 100
ml of blood has a BAC of 0.10 percent.
``Commission.'' The U.S. Nuclear Regulatory Commission or its duly
authorized representatives.
``Chain-of-custody.'' Procedures to account for the integrity of
each specimen by tracking its handling and storage from the point of
specimen collection to final disposition of the specimen.
``Collection site.'' A place designated by the licensee where
individuals present themselves for the purpose of providing a specimen
of their urine, breath, and/or blood to be analyzed for the presence of
drugs or alcohol.
``Collection site person.'' A person who instructs and assists
individuals at a collection site and who receives and makes an initial
examination of the specimen(s) provided by those individuals. A
collection site person shall have successfully completed training to
carry out this function or shall be a licensed medical professional or
technician who is provided instructions for collection under this part
and certifies completion as required herein. In any case where: (a) a
collection is observed or (b) collection is monitored by nonmedical
personnel, the collection site person must be a person of the same
gender as the donor.
``Confirmatory test.'' A second analytical procedure to identify the
presence of a specific drug or drug metabolite which is independent of
the initial screening test and which uses a different technique and
chemical principle from that of the initial test in order to ensure
reliability and accuracy. (At this time gas chromatography/mass
spectrometry [GC/MS] is the only authorized confirmation method for
cocaine, marijuana, opiates, amphetamines, phencyclidine). For
determining blood alcohol levels, a ``confirmatory test'' means a second
test using another breath alcohol analysis device. Further confirmation
upon demand will be by gas chromatography analysis of blood.
``Confirmed positive test.'' The result of a confirmatory test that
has established the presence of drugs, drug metabolites, or alcohol in a
specimen at or above the cut-off level, and that has been deemed
positive by the Medical Review Officer (MRO) after evaluation. A
``confirmed positive test'' for alcohol can also be obtained as a result
of a confirmation of blood alcohol levels with a second breath analysis
without MRO evaluation.
``HHS-certified laboratory.'' A urine and blood testing laboratory
that maintains certification to perform drug testing under the
Department of Health and Human Services (HHS) ``Mandatory Guidelines for
Federal Workplace Drug Testing Programs'' (53 FR 11970).
``Illegal drugs.'' Those drugs included in Schedules I through V of
the Controlled Substances Act (CSA), but not when used pursuant to a
valid prescription or when used as otherwise authorized by law.
``Initial or screening test.'' An immunoassay screen for drugs or
drug metabolites to eliminate ``negative'' urine specimens from further
consideration or the first breathalyzer test for alcohol.
``Licensee's testing facility.'' A drug testing facility operated by
the licensee or one of its vendors or contractors to perform the initial
testing of urine samples and to perform initial breath tests for
alcohol. Such a testing facility is optional and not required to
maintain HHS certification under this part.
``Medical Review Officer.'' A licensed physician responsible for
receiving laboratory results generated by an employer's drug testing
program who has knowledge of substance abuse disorders and has
appropriate medical training to interpret and evaluate an individual's
positive test result together with his or her medical history and any
other relevant biomedical information.
``Permanent record book.'' A permanently bound book in which
identifying data on each specimen collected at a collection site are
permanently recorded in the sequence of collection.
``Reason to believe.'' Reason to believe that a particular
individual may alter or substitute the urine specimen.
``Split sample.'' A portion of a urine specimen that may be stored
by the licensee to be tested in the event of appeal.
Subpart B--Scientific and Technical Requirements
2.1 The Substances
(a) Licensees shall, as a minimum, test for marijuana, cocaine,
opiates, amphetamines, phencyclidine, and alcohol for pre-access, for-
cause, random, and follow-up tests.
(b) Licensees may test for any illegal drugs during a for-cause
test, or analysis of any specimen suspected of being adulterated or
diluted through hydration or other means.
(c) Licensees shall establish rigorous testing procedures that are
consistent with the intent of these guidelines for any other drugs not
specified in these guidelines for which testing is authorized under 10
CFR 26, so that the appropriateness of the use of these substances can
be evaluated by the Medical Review Officer to ensure that individuals
granted unescorted access are fit for maintaining access to and for
performing duties in protected areas.
[[Page 451]]
(d) Specimens collected under NRC regulations requiring compliance
with this part may only be designated or approved for testing as
described in this part and shall not be used to conduct any other
analysis or test without the permission of the tested individual.
(e) This section does not prohibit procedures reasonably incident to
analysis of a specimen for controlled substances (e.g., determination of
pH on tests for specific gravity, creatinine concentration, or presence
of adulterants).
2.2 General Administration of Testing
The licensee testing facilities and HHS-certified laboratories
described in this part shall develop and maintain clear and well-
documented procedures for collection, shipment, and accession of urine
and blood specimens under this part. Such procedures shall include, as a
minimum, the following:
(a) Use of a chain-of-custody form. The original shall accompany the
specimen to the HHS-certified laboratory. A copy shall accompany any
split sample. The form shall be a permanent record on which is retained
identity data (or codes) on the employee and information on the specimen
collection process and transfers of custody of the specimen.
(b) Use of a tamperevident sealing system designed in a manner such
that the specimen container top can be sealed against undetected
opening, the container can be identified with a unique identifying
number identical to that appearing on the chain-of-custody form, and
space has been provided to initial the container affirming its identity.
For purposes of clarity, this requirement assumes use of a system made
up of one or more pre-printed labels and seals (or a unitary label/
seal), but use of other, equally effective technologies is authorized.
(c) Use of a shipping container in which one or more specimens and
associated paperwork may be transferred and which can be sealed and
initialled to prevent undetected tampering.
(d) Written procedures, instructions, and training shall be provided
as follows:
(1) Licensee collection site procedures and training of collection
site personnel shall clearly emphasize that the collection site person
is responsible for maintaining the integrity of the specimen collection
and transfer process, carefully ensuring the modesty and privacy of the
individual tested, and is to avoid any conduct or remarks that might be
construed as accusatorial or otherwise offensive or inappropriate.
(2) A non-medical collection site person shall receive training in
compliance with this appendix and shall demonstrate proficiency in the
application of this appendix prior to serving as a collection site
person. A medical professional, technologist, or technician licensed or
otherwise approved to practice in the jurisdiction in which collection
occurs may serve as a collection site person if that person is provided
the instructions described in 2.2(3) and performs collections in
accordance with those instructions.
(3) Collection site persons shall be provided with detailed,
clearly-illustrated, written instructions on the collection of specimens
in compliance with this part. Individuals subject to testing shall also
be provided standard written instructions setting forth their
responsibilities.
(4) The option to provide a blood specimen for confirmatory analysis
following a positive breath test shall be specified in the written
instructions provided to individuals tested. The instructions shall also
state that failure to request a confirmatory blood test indicates that
the individual accepts the breath test results.
2.3 Preventing Subversion of Testing
Licensees shall carefully select and monitor persons responsible for
administering the testing program (e.g., collection site persons,
laboratory technicians, specimen couriers, and those selecting and
notifying personnel to be tested), based upon the highest standards for
honesty and integrity, and shall implement measures to ensure that these
standards are maintained. As a minimum, these measures shall ensure that
the integrity of such persons is not compromised or subject to efforts
to compromise due to personal relationships with any individuals subject
to testing.
As a minimum:
(1) Supervisors, co-workers, and relatives of the individual being
tested shall not perform any collection, assessment, or evaluation
procedures.
(2) Appropriate background checks and psychological evaluations
shall be completed prior to assignment of any tasks associated with the
administration of the program, and shall be conducted at least once
every three years.
(3) Persons responsible for administering the testing program shall
be subjected to a behavioral observation program designed to assure that
they continue to meet the highest standards for honesty and integrity.
2.4 Specimen Collection Procedures
(a) ``Designation of Collection Site.'' Each drug testing program
shall have one or more designated collection sites which have all
necessary personnel, materials, equipment, facilities, and supervision
to provide for the collection, security, temporary storage, and shipping
or transportation of urine or blood specimens to a drug testing
laboratory. A properly equipped mobile facility that meets the
requirements of this part is an acceptable collection site.
[[Page 452]]
(b) ``Collection Site Person.'' A collection site person shall have
successfully completed training to carry out this function. In any case
where the collection of urine is observed, the collection site person
must be a person of the same gender as the donor. Persons drawing blood
shall be qualified to perform that task.
(c) ``Security.'' The purpose of this paragraph is to prevent
unauthorized access which could compromise the integrity of the
collection process or the specimen. Security procedures shall provide
for the designated collection site to be secure. If a collection site
facility cannot be dedicated solely to drug and alcohol testing, the
portion of the facility used for testing shall be secured during that
testing.
(1) A facility normally used for other purposes, such as a public
rest room or hospital examining room, may be secured by visual
inspection to ensure other persons are not present, and that undetected
access (e.g., through a rear door not in the view of the collection site
person) is impossible. Security during collection may be maintained by
effective restriction of access to collection materials and specimens.
In the case of a public rest room, the facility must be posted against
access during the entire collection procedure to avoid embarrassment to
the individual or distraction of the collection site person.
(2) If it is impractical to maintain continuous physical security of
a collection site from the time the specimen is presented until the
sealed container is transferred for shipment, the following minimum
procedures shall apply: The specimen shall remain under the direct
control of the collection site person from delivery to its being sealed
in a mailer or secured for shipment. The mailer shall be immediately
mailed, maintained in secure storage, or remain until mailed under the
personal control of the collection site person. These minimum procedures
shall apply to the mailing of specimens to licensee testing facilities
from collection sites (except where co-located) as well as to the
mailing of specimens to HHS-certified laboratories. As an option,
licensees may ship several specimens via courier in a locked or sealed
shipping container.
(d) ``Chain-of-Custody.'' Licensee chain-of-custody forms shall be
properly executed by authorized collection site personnel upon receipt
of specimens. Handling and transportation of urine and blood specimens
from one authorized individual or place to another shall always be
accomplished through chain-of-custody procedures. Every effort shall be
made to minimize the number of persons handling the specimens.
(e) ``Access to Authorized Personnel Only.'' No unauthorized
personnel shall be permitted in any part of the designated collection
site where specimens are collected or stored. Only the collection site
person may handle specimens prior to their securement in the mailing or
shipping container or monitor or observe specimen collection (under the
conditions specified in this part). In order to promote security of
specimens, avoid distraction of the collection site person, and ensure
against any confusion in the identification of specimens, a collection
site person shall conduct only one collection procedure at any given
time. For this purpose, a collection procedure is complete when the
specimen container has been sealed and initialed, the chain-of-custody
form has been executed, and the individual has departed the collection
site.
(f) ``Privacy.'' Procedures for collecting urine specimens shall
allow individual privacy unless there is reason to believe that a
particular individual may alter or substitute the specimen to be
provided. For purposes of this appendix the following circumstances are
the exclusive grounds constituting a reason to believe that the
individual may alter or substitute a urine specimen:
(1) The individual has presented a urine specimen that falls outside
the normal temperature range, and the individual declines to provide a
measurement of oral body temperature by sterile thermometer, as provided
in paragraph (g)(14) of this appendix, or the oral temperature does not
equal or exceed that of the specimen.
(2) The last urine specimen provided by the individual (i.e., on a
previous occasion) was determined by the laboratory to have a specific
gravity of less than 1.003 or a creatinine concentration below .2 g/L.
(3) The collection site person observes conduct clearly and
unequivocally indicating an attempt to substitute or adulterate the
sample (e.g., substitute urine in plain view, blue dye in specimen
presented, etc.).
(4) The individual has previously been determined to have used a
substance inappropriately or without medical authorization and the
particular test is being conducted as a part of a rehabilitation program
or on return to service after evaluation and/or treatment for a
confirmed positive test result.
(g) ``Integrity and Identity of Specimens.'' Licensees shall take
precautions to ensure that a urine specimen is not adulterated or
diluted during the collection procedure, that a blood sample or breath
exhalent tube cannot be substituted or tampered with, and that the
information on the specimen container and in the record book can
identify the individual from whom the specimen was collected. The
following minimum precautions shall be taken to ensure that authentic
specimens are obtained and correctly identified:
(1) To deter the dilution of urine specimens at the collection site,
toilet bluing agents shall be placed in toilet tanks wherever possible,
so the reservoir of water in the toilet
[[Page 453]]
bowl always remains blue. There shall be no other source of water (e.g.,
no shower or sink) in the enclosure where urination occurs. If there is
another source of water in the enclosure, it shall be effectively
secured or monitored to ensure it is not used (undetected) as a source
for diluting the specimen.
(2) When an individual arrives at the collection site for a urine or
breath test, the collection site person shall ensure that the individual
is positively identified as the person selected for testing (e.g.,
through presentation of photo identification or identification by the
employer's representative). If the individual's identity cannot be
established, the collection site person shall not proceed with the
collection.
(3) If the individual fails to arrive for a urine or breath test at
the assigned time, the collection site person shall contact the
appropriate authority to obtain guidance on the action to be taken.
(4) After the individual has been positively identified, the
collection site person shall ask the individual to sign a consent-to-
testing form and to list all of the prescription medications and over-
the-counter preparations that he or she can remember using within the
past 30 days.
(5) The collection site person shall ask the individual to remove
any unnecessary outer garments such as a coat or jacket that might
conceal items or substances that could be used to tamper with or
adulterate the individual's urine, breath, or blood specimen. The
collection site person shall ensure that all personal belongings such as
a purse or briefcase remain with the outer garments outside of the room
in which the blood, breath, or urine sample is collected. The individual
may retain his or her wallet.
(6) The individual shall be instructed to wash and dry his or her
hands prior to urination.
(7) After washing hands prior to urination, the individual shall
remain in the presence of the collection site person and shall not have
access to any water fountain, faucet, soap dispenser, cleaning agent or
any other materials which could be used to adulterate the urine
specimen.
(8) The individual may provide his/her urine specimen in the privacy
of a stall or otherwise partitioned areas that allows for individual
privacy.
(9) The collection site person shall note any unusual behavior or
appearance in the permanent record book and on the chain-of-custody
form.
(10) In the exceptional event that a designated collection site is
inaccessible and there is an immediate requirement for urine specimen
collection (e.g., an accident investigation), a public or on-site rest
room may be used according to the following procedures. A collection
site person of the same gender as the individual shall accompany the
individual into the rest room which shall be made secure during the
collection procedure. If possible, a toilet bluing agent shall be placed
in the bowl and any accessible toilet tank. The collection site person
shall remain in the rest room, but outside the stall, until the specimen
is collected. If no bluing agent is available to deter specimen
dilution, the collection site person shall instruct the individual not
to flush the toilet until the specimen is delivered to the collection
site person. After the collection site person has possession of the
specimen, the individual will be instructed to flush the toilet and to
participate with the collection site person in completing the chain-of-
custody procedures.
(11) Upon receiving a urine specimen from the individual, the
collection site person shall determine that it contains at least 60
milliliters of urine. If there is less than 60 milliliters of urine in
the container, additional urine shall be collected in a separate
container to reach a total of 60 milliliters. (The temperature of the
partial specimen in each separate container shall be measured in
accordance with paragraph (f)(13) of this section, and the partial
specimens shall be combined in one container.) The individual may be
given a reasonable amount of liquid to drink for this purpose (e.g., a
glass of water). If the individual fails for any reason to provide 60
milliliters of urine, the collection site person shall contact the
appropriate authority to obtain guidance on the action to be taken.
(12) After the urine specimen has been provided and submitted to the
collection site person, the individual shall be allowed to wash his or
her hands.
(13) Immediately after the urine specimen is collected, the
collection site person shall measure the temperature of the specimen.
The temperature measuring device used must accurately reflect the
temperature of the specimen and not contaminate the specimen. The time
from urination to temperature measurement is critical and in no case
shall exceed 4 minutes.
(14) If the temperature of a urine specimen is outside the range of
32.5- 37.7 C/90.5-99.8
F, that is a reason to believe that the individual may
have altered or substituted the specimen, and another specimen shall be
collected under direct observation of a same gender collection site
person and both specimens shall be forwarded to the laboratory for
testing. An individual may volunteer to have his or her oral temperature
taken to provide evidence to counter the reason to believe the
individual may have altered or substituted the specimen caused by the
specimen's temperature falling outside the prescribed range.
(15) Immediately after a urine specimen is collected, the collection
site person shall also inspect the specimen to determine its
[[Page 454]]
color and look for any signs of contaminants. Any unusual findings shall
be noted in the permanent record book.
(16) All urine specimens suspected of being adulterated or found to
be diluted shall be forwarded to the laboratory for testing.
(17) Whenever there is reason to believe that a particular
individual may alter or substitute the urine specimen to be provided, a
second specimen shall be obtained as soon as possible under the direct
observation of a same gender collection site person. Where appropriate,
measures will be taken to prevent additional hydration.
(18) Alcohol breath tests shall be delayed at least 15 minutes if
any source of mouth alcohol (e.g., breath fresheners) or any other
substances are ingested (e.g., eating, smoking, regurgitation of stomach
contents from vomiting or burping). The collection site person shall
ensure that each breath specimen taken comes from the end, rather than
the beginning, of the breath expiration. For each screening test, two
breath specimens shall be collected from each individual no less than
two minutes apart and no more than 10 minutes apart. The test results
shall be considered accurate if the result of each measurement is within
plus or minus 10 percent of the average of the two measurements. If the
two tests do not agree, the breath tests shall be repeated on another
evidential-grade breath analysis device. Confirmatory testing is
accomplished by repeating the above procedure on another evidential-
grade breath analysis device.
(19) If the alcohol breath tests indicates that the individual is
positive for a BAC at or above the 0.04 percent cut-off level, the
individual may request a confirmatory blood test, at his or her
discretion. All vacuum tube and needle assemblies used for blood
collection shall be factory-sterilized. The collection site person shall
ensure that they remain properly sealed until used. Antiseptic swabbing
of the skin shall be performed with a nonethanol antiseptic. Sterile
procedures shall be followed when drawing blood and transferring the
blood to a storage container; in addition, the container must be sterile
and sealed.
(20) Both the individual being tested and the collection site person
shall keep urine and blood specimens in view at all times prior to their
being sealed and labeled. If a urine specimen is split (as described in
Section 2.7(j)) and if any specimen is transferred to a second
container, the collection site person shall request the individual to
observe the splitting of the urine sample or the transfer of the
specimen and the placement of the tamperevident seal over the container
caps and down the sides of the containers.
(21) The collection site person and the individual shall be present
at the same time during procedures outlined in paragraphs (h) through
(j) of this section.
(22) The collection site person shall place securely on each
container an identification label which contains the date, the
individual's specimen number, and any other identification information
provided or required by the drug testing program. If separate from the
labels, the tamperevident seals shall also be applied.
(23) The individual shall initial the identification labels on the
specimen containers for the purpose of certifying that it is the
specimen collected from him or her.
(i) The individual shall be asked to read and sign a statement on
either the chain-of-custody form or in the permanent record book
certifying that the specimens identified as having been collected from
him or her are in fact the specimen he or she provided.
(ii) The individual shall be provided an opportunity to set forth on
the urine chain-of-custody form information concerning medications taken
or administered in the past 30 days.
(24) The collection site person shall enter in the permanent record
book all information identifying the specimens. The collection site
person shall sign the permanent record book next to the identifying
information.
(25) A higher level supervisor in the drug testing program shall
review and concur in advance with any decision by a collection site
person to obtain a urine specimen under the direct observation of a same
gender collection site person based on a reason to believe that the
individual may alter or substitute the specimen to be provided.
(26) The collection site person shall complete the chain-of-custody
forms for both the aliquot and the split sample, if collected, and shall
certify proper completion of the collection.
(27) The specimens and chain-of-custody forms are now ready for
transfer to the laboratory or the licensee's testing facility. If the
specimens are not immediately prepared for shipment, they shall be
appropriately safeguarded during temporary storage.
(28) While any part of the above chain-of-custody procedures is
being performed, it is essential that the specimens and custody
documents be under the control of the involved collection site person.
The collection site person shall not leave the collection site in the
interval between presentation of the specimen by the individual and
securement of the samples with identifying labels bearing the
individual's specimen identification numbers and seals initialled by the
individual. If the involved collection site person leaves his or her
work station momentarily, the specimens and chain-of-custody forms shall
be taken with him or her or shall be secured. If the collection site
person is leaving for an extended period of time, the specimens shall be
packaged for transfer to the laboratory before he or she leaves the
site.
[[Page 455]]
(h) ``Collection Control.'' To the maximum extent possible,
collection site personnel shall keep the individual's specimen
containers within sight both before and after the individual has
urinated or provided a breath or blood sample. After the specimen is
collected and whenever urine specimens are split, they shall be properly
sealed and labeled. A chain-of-custody form shall be used for
maintaining control and accountability of each specimen from the point
of collection to final disposition of the specimen. The date and purpose
shall be documented on the chain-of-custody form each time a specimen is
handled or transferred, and every individual in the chain of custody
shall be identified. Every effort shall be made to minimize the number
of persons handling specimens.
(i) ``Transportation to Laboratory or Testing Facility.'' Collection
site personnel shall arrange to transfer the collected specimens to the
drug testing laboratory or licensee testing facility. To transfer
specimens off-site for initial screening and for a second screen and
confirmatory analysis of presumptive positive specimens and for
transferring suspect specimens to a laboratory for analysis under
special processing [Section 2.7(d)], the specimens shall be placed in
containers designed to minimize the possibility of damage during
shipment (e.g., specimen boxes, padded mailers, or bulk shipping
containers with that capability) and those containers shall be securely
sealed to eliminate the possibility of undetected tampering. On the tape
sealing the container, the collection site person shall sign and enter
the date specimens were sealed in the containers for shipment. The
collection site personnel shall ensure that the chain-of-custody
documentation is attached to each container sealed for shipment to the
drug testing laboratory.
(j) ``Failure to Cooperate.'' If the individual refuses to cooperate
with the urine collection or breath analysis process (e.g., refusal to
provide a complete specimen, complete paperwork, initial specimen), then
the collection site person shall inform the Medical Review Officer and
shall document the non-cooperation in the permanent record book and on
the specimen custody and control form. The Medical Review Officer shall
report the failure to cooperate to the appropriate management. The
provision of blood specimens for use to confirm a positive breath test
for alcohol shall be entirely voluntary, at the individual's discretion.
In the absence of a voluntary blood test the second positive breath test
shall be considered a confirmed positive.
2.5. HHS-certified Laboratory Personnel
(a) ``Day-to-Day Management of the HHS-certified Laboratories.''
(1) The HHS-certified laboratory shall have a qualified individual
to assume professional, organizational, educational, and administrative
responsibility for the laboratories' drug testing facilities.
(2) This individual shall have documented scientific qualifications
in analytical forensic toxicology. Minimum qualifications are:
(i) Certification as a laboratory director by the appropriate State
in forensic or clinical laboratory toxicology; or
(ii) A Ph.D. in one of the natural sciences with an adequate
undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology, or
(iii) Training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with additional
training and laboratory/research experience in biology, chemistry, and
pharmacology or toxicology, and
(iv) In addition to the requirements in (i), (ii), and (iii) above,
minimum qualifications also require:
(A) Appropriate experience in analytical forensic toxicology
including experience with the analysis of biological material for drugs
of abuse; and
(B) Appropriate training and/or experience in forensic applications
of analytical toxicology, e.g., publications, court testimony, research
concerning analytical toxicology of drugs of abuse, or other factors
which qualify the individual as an expert witness in forensic
toxicology.
(3) This individual shall be engaged in and responsible for the day-
to-day management of the testing laboratory even where another
individual has overall responsibility for an entire multispecialty
laboratory.
(4) This individual shall be responsible for ensuring that there are
enough personnel with adequate training and experience to supervise and
conduct the work of their testing laboratories. He or she shall assure
the continued competency of laboratory personnel by documenting their
inservice training, reviewing their work performance, and verifying
their skills.
(5) This individual shall be responsible for the laboratory's having
a procedure manual which is complete, up-to-date, available for
personnel performing tests, and followed by those personnel. The
procedure manual shall be reviewed, signed, and dated by this
responsible individual whenever procedures are first placed into use or
changed or when a new individual assumes responsibility for management
of the laboratory. Copies of all procedures and dates on which they are
in effect shall be maintained. (Specific contents of the procedure
manual are described in Section 2.7(0) of this appendix).
(6) This individual shall be responsible for maintaining a quality
assurance program to assure the proper performance and reporting of all
test results; for maintaining acceptable analytical performance for all
controls
[[Page 456]]
and standards; for maintaining quality control testing; and for assuring
and documenting the validity, reliability, accuracy, precision, and
performance characteristics of each test and test system.
(7) This individual shall be responsible for taking all remedial
actions necessary to maintain satisfactory operation and performance of
the laboratory in response to quality control systems not being within
performance specifications, errors in result reporting or in analysis of
performance testing results. This individual shall ensure that test
results are not reported until all corrective actions have been taken
and he or she can assure that the test results provided are accurate and
reliable.
(b) ``Test Validation.'' The laboratory's urine drug testing
facility shall have a qualified individual(s) who reviews all pertinent
data and quality control results in order to attest to the validity of
the laboratory's test reports. A laboratory may designate more than one
person to perform this function. This individual(s) may be any employee
who is qualified to be responsible for day-to-day management or
operation of the drug testing laboratory.
(c) ``Day-to-Day Operations and Supervision of Analysts.'' The
laboratory's urine drug testing facility shall have an individual to be
responsible for day-to-day operations and to supervise the technical
analysts. This individual(s) shall have at least a bachelor's degree in
the chemical or biological sciences or medical technology or equivalent.
He or she shall have training and experience in the theory and practice
of the procedures used in the laboratory, resulting in his or her
thorough understanding of quality control practices and procedures; the
review, interpretation, and reporting of test results; maintenance of
chain-of-custody; and proper remedial actions to be taken in response to
test systems being out of control limits or detecting aberrant test or
quality control results.
(d) ``Other Personnel.'' Other technicians or nontechnical staff
shall have the necessary training and skills for the tasks assigned.
(e) ``Training.'' The laboratory's testing program shall make
available continuing education programs to meet the needs of laboratory
personnel.
(f) ``Files.'' Laboratory personnel files shall include:
r[eacute]sum[eacute] of training and experience; certification or
license, if any; references; job descriptions; records of performance
evaluation and advancement; incident reports; and results of tests which
establish employee competency for the position he or she holds, such as
a test for color blindness, if appropriate.
2.6 Licensee Testing Facility Personnel
(a) ``Day-to-Day Management of Operations.'' Any licensee testing
facility shall have an individual to be responsible for day-to-day
operations and to supervise the testing technicians. This individual(s)
shall have at least a bachelor's degree in the chemical or biological
sciences or medical technology or equivalent. He or she shall have
training and experience in the theory and practice of the procedures
used in the licensee testing facility, resulting in his or her thorough
understanding of quality control practices and procedures; the review,
interpretation, and reporting of test results; and proper remedial
actions to be taken in response to detecting aberrant test or quality
control results.
(b) ``Other Personnel.'' Other technicians or nontechnical staff
shall have the necessary training and skills for the tasks assigned.
(c) ``Files.'' Licensees' testing facility personnel files shall
include: r[eacute]sum[eacute] of training and experience; certification
or license, if any; references; job descriptions; records of performance
evaluation and advancement; incident reports; results of tests which
establish employee competency for the position he or she holds, such as
a test for color blindness, if appropriate and appropriate data to
support determinations of honesty and integrity conducted in accordance
with Section 2.3 of this appendix.
2.7 Laboratory and Testing Facility Analysis Procedures
(a) ``Security and Chain-of-Custody.''
(1) HHS-certified drug testing laboratories and any licensee testing
facility shall be secure at all times. They shall have in place
sufficient security measures to control access to the premises and to
ensure that no unauthorized personnel handle specimens or gain access to
the laboratory processes or to areas where records and split samples are
stored. Access to these secured areas shall be limited to specifically
authorized individuals whose authorization is documented. All authorized
visitors and maintenance and service personnel shall be escorted at all
times in the HHS-certified laboratory and in the licensee's testing
facility. Documentation of individuals accessing these areas, dates, and
times of entry and purpose of entry must be maintained.
(2) Laboratories and testing facilities shall use chain-of-custody
procedures to maintain control and accountability of specimens from
receipt through completion of testing, reporting of results, during
storage, and continuing until final disposition of specimens. The date
and purpose shall be documented on an appropriate chain-of-custody form
each time a specimen is handled or transferred, and every individual in
the chain shall be
[[Page 457]]
identified. Accordingly, authorized technicians shall be responsible for
each urine specimen or aliquot in their possession and shall sign and
complete chain-of-custody forms for those specimens or aliquots as they
are received.
(b) ``Receiving.''
(1) When a shipment of specimens is received, laboratory and
licensee's testing facility personnel shall inspect each package for
evidence of possible tampering and compare information on specimen
containers within each package to the information on the accompanying
chain-of-custody forms. Any direct evidence of tampering or
discrepancies in the information on specimen containers and the
licensee's chain-of-custody forms attached to the shipment shall be
reported within 24 hours to the licensee, in the case of HHS-certified
laboratories, and shall be noted on the laboratory's chain-of-custody
form which shall accompany the specimens while they are in the
laboratory's possession. Indications of tampering with specimens at a
testing facility operated by a licensee shall be reported within 8 hours
to senior licensee management.
(2) Specimen containers will normally be retained within the
laboratory's or testing facility's accession area until all analyses
have been completed. Aliquots and the chain-of-custody forms shall be
used by laboratory or testing facility personnel for conducting initial
and confirmatory tests, as appropriate.
(c) ``Short-Term Refrigerated Storage.'' Specimens that do not
receive an initial test within 7 days of arrival at the laboratory or
are not shipped within 6 hours from the licensee's testing facility and
any retained split samples shall be placed in secure refrigeration
units. Temperatures shall not exceed 6 C. Emergency power
equipment shall be available in case of prolonged power failure.
(d) ``Specimen Processing.'' Urine specimens identified as
presumptive positive by a licensee's testing facility shall be shipped
to an HHS-certified laboratory for testing. Laboratory facilities for
drug testing will normally process urine specimens by grouping them into
batches. The number of specimens in each batch may vary significantly
depending on the size of the laboratory and its workload. When
conducting either initial or confirmatory tests at either the licensee's
testing facility or an HHS-certified laboratory, every batch shall
contain an appropriate number of standards for calibrating the
instrumentation and a minimum of 10 percent controls. Both quality
control and blind performance test samples shall appear as ordinary
samples to laboratory analysts. Special processing may be conducted to
analyze specimens suspected of being adulterated or diluted (including
hydration). Any evidence of adulteration or dilution, and any detected
trace amounts of drugs or metabolites, shall be reported to the Medical
Review Officer.
(e) ``Preliminary Initial Test.''
(1) For the analysis of urine specimens, any preliminary test
performed by a licensee's testing facility and the initial screening
test performed by a HHS-certified laboratory shall use an immunoassay
which meets the requirements of the Food and Drug Administration for
commercial distribution. The initial test of breath for alcohol
performed at the collection site shall use a breath measurement device
which meets the requirements of Section 2.7(o)(3). The following initial
cut-off levels shall be used when screening specimens to determine
whether they are negative for the indicated substances:
Initial test cut-off level (ng/ml)
Marijuana metabolites................................................100
Cocaine metabolites..................................................300
Opiate metabolites..................................................300*
Phencyclidine.........................................................25
Amphetamines.......................................................1,000
Alcohol........................................................0.04% BAC
*25 ng/ml is immunoassay specific for free morphine.
In addition, licensees may specify more stringent cutoff levels.
Results shall be reported for both levels in such cases.
(2) The list of substances to be tested and the cut-off levels are
subject to change by the NRC in response to industry experience and
changes to the HHS Guidelines made by the Department of Health and Human
Services as advances in technology, additional experience, or other
considerations warrant the inclusion of additional substances and other
concentration levels.
(f) ``Confirmatory Test.''
(1) Specimens which test negative as a result of this second
screening shall be reported as negative to the licensee and will not be
subject to any further testing unless special processing of the specimen
is desired because adulteration or dilution is suspected.
(2) All urine samples identified as presumptive positive on the
screening test performed by a HHS-certified laboratory shall be
confirmed using gas chromatography/mass spectrometry (GC/MS) techniques
at the cut-off values listed in this paragraph for each drug, and at the
cut-off values required by the licensee's unique program, where
differences exist. All confirmations shall be by quantitative analysis.
Concentrations which exceed the linear region of the standard curve
shall be documented in the laboratory record as ``greater than highest
standard curve value.''
Confirmatory test cut-off level (ng/ml)
Marijuana metabolite.................................................15*
Cocaine metabolite.................................................150**
Opiates:
Morphine............................................................300
[[Page 458]]
Codeine.............................................................300
Phencyclidine.........................................................25
Amphetamines:
Amphetamine.........................................................500
Methamphetamine.....................................................500
Alcohol........................................................0.04% BAC
*Delta-9-tetrahydrocannabinol-9-carboxylic acid.
**Benzoylecgonine.
In addition, licensees may specify more stringent cut-off levels.
Results shall be reported for both levels in such cases.
(3) The analytic procedure for confirmatory analysis of blood
specimens voluntarily provided by individuals testing positive for
alcohol on a breath test shall be gas chromatography analysis.
(4) The list of substances to be tested and the cut-off levels are
subject to change by the NRC in response to industry experience and
changes to the HHS Guidelines made by the Department of Health and Human
Services as advances in technology, additional experience, or other
considerations warrant the inclusion of additional substances and other
concentration levels.
(5) Confirmatory tests for opiates shall include a test for 6-
monoacetylmorphine (MAM) if the screening test is presumptive positive
for morphine.
(g) ``Reporting Results.''
(1) The HHS-certified laboratory shall report test results to the
licensee's Medical Review Officer within 5 working days after receipt of
the specimen by the laboratory. Before any test result is reported (the
results of initial tests, confirmatory tests, or quality control data),
it shall be reviewed and the test certified as an accurate report by the
responsible individual at the laboratory. The report shall identify the
substances tested for, whether positive or negative, the cut-off(s) for
each, the specimen number assigned by the licensee, and the drug testing
laboratory specimen identification number. The results (positive and
negative) for all specimens submitted at the same time to the laboratory
shall be reported back to the Medical Review Officer at the same time
when possible.
(2) The HHS-certified laboratory and any licensee testing facility
shall report as negative all specimens, except suspect specimens being
analyzed under special processing, which are negative on the initial
test or negative on the confirmatory test. Specimens testing positive on
the confirmatory analysis shall be reported positive for a specific
substance. Except as provided in Sec. 26.24(d), presumptive positive
results of preliminary testing at the licensee's testing facility will
not be reported to licensee management.
(3) The Medical Review Officer may routinely obtain from the HHS-
certified laboratory, and the laboratory shall provide, quantitation of
test results. The Medical Review Officer may only disclose quantitation
of test results for an individual to licensee management, if required in
an appeals process, or to the individual under the provisions of Section
3.2. (This does not preclude the provision of program performance data
under the provisions of 10 CFR 26.71(d).) Quantitation of negative tests
for urine specimens shall not be disclosed, except where deemed
appropriate by the Medical Review Officer for proper disposition of the
results of tests of suspect specimens. Alcohol quantitation for a blood
specimen shall be provided to licensee management with the Medical
Review Officer's evaluation.
(4) The laboratory may transmit results to the Medical Review
Officer by various electronic means (e.g., teleprinters, facsimile, or
computer) in a manner designed to ensure confidentiality of the
information. Results may not be provided verbally by telephone from HHS-
certified laboratory personnel to the Medical Review Officer. The HHS-
certified laboratory must ensure the security of the data transmission
and limit access to any data transmission, storage, and retrieval
system.
(5) The laboratory shall send only to the Medical Review Officer a
certified copy of the original chain-of-custody form signed by the
individual responsible for day-to-day management of the drug testing
laboratory or the individual responsible for attesting to the validity
of the test reports and attached to which shall be a copy of the test
report.
(6) The HHS-certified laboratory and the licensee's testing facility
shall provide to the licensee official responsible for coordination of
the fitness-for-duty program a monthly statistical summary of urinalysis
and blood testing and shall not include in the summary any personal
identifying information. Initial test data from the licensee's testing
facility and the HHS-certified laboratory, and confirmation data from
HHS-certified laboratories shall be included for test results reported
within that month. Normally this summary shall be forwarded from HHS-
certified laboratories by registered or certified mail and from the
licensee's testing facility not more than 14 calendar days after the end
of the month covered by the summary. The summary shall contain the
following information:
(i) Initial Testing:
(A) Number of specimens received;
(B) Number of specimens reported out; and
(C) Number of specimens screened positive for:
Marijuana metabolites
Cocaine metabolites
Opiate metabolites
Phencyclidine
Amphetamines
Alcohol
(ii) Confirmatory Testing:
[[Page 459]]
(A) Number of specimens received for confirmation;
(B) Number of specimens confirmed positive for:
Marijuana metabolite
Cocaine metabolite
Morphine, codeine
Phencyclidine
Amphetamine
Methamphetamine
Alcohol
(7) The statistics shall be presented for both the cut-off levels in
these guidelines and any more stringent cut-off levels which licensees
may specify. The HHS-certified laboratory and the licensee's testing
facility shall make available quantitative results for all samples
tested when requested by the NRC or the licensee for which the
laboratory is performing drug testing services.
(8) Unless otherwise instructed by the licensee in writing, all
records pertaining to a given urine or blood specimen shall be retained
by the HHS-certified drug testing laboratory and the licensee's testing
facility for a minimum of 2 years.
(h) ``Long-Term Storage.'' Long-term frozen storage (-20
C or less) ensures that positive urine specimens will be
available for any necessary retest during administrative or disciplinary
proceedings. Unless otherwise authorized in writing by the licensee,
HHS-certified laboratories shall retain and place in properly secured
long-term frozen storage for a minimum of 1 year all specimens confirmed
positive. Within this 1-year period a licensee or the NRC may request
the laboratory to retain the specimen for an additional period of time,
but if no such request is received, the laboratory may discard the
specimen after the end of 1 year, except that the laboratory shall be
required to maintain any specimens under legal challenge for an
indefinite period. Any split samples retained by the licensee shall be
transferred into long-term storage upon determination by the Medical
Review Officer that the specimen has a confirmed positive test.
(i) ``Retesting Specimens.'' Because some analytes deteriorate or
are lost during freezing and/or storage, quantitation for a retest is
not subject to a specific cut-off requirement but must provide data
sufficient to confirm the presence of the drug or metabolite.
(j) ``Split Samples.'' Urine specimens may be split, at the
licensee's discretion, into two parts at the collection site. One half
of such samples (hereafter called the aliquot) shall be analyzed by the
licensee's testing facility or the HHS-certified laboratory for the
licensee's purposes as described in this appendix. The other half of the
sample (hereafter called the split sample) may be withheld from transfer
to the laboratory, sealed, and stored in a secure manner by the licensee
until the aliquot has been determined to be negative or until the
positive result of a screening test has been confirmed. As soon as the
aliquot has tested negative, the split sample in storage may be
destroyed. If the aliquot tests positive by confirmatory testing, then,
at the tested individual's request, the split sample may be forwarded on
that day to another HHS-certified laboratory that did not test the
aliquot. The chain-of-custody and testing procedures to which the split
sample is subject, shall be the same as those used to test the initial
aliquot and shall meet the standards for retesting specimens [Section
2.7(i)]. The quantitative results of any second testing process shall be
made available to the Medical Review Officer and to the individual
tested.
(k) ``Subcontracting.'' HHS-certified laboratories shall not
subcontract and shall perform all work with their own personnel and
equipment unless otherwise authorized by the licensee. The laboratory
must be capable of performing testing of the five classes of drugs
(marijuana, cocaine, opiates, phencyclidine, and amphetamines) and of
whole blood and confirmatory GC/MS methods specified in these
guidelines.
(l) ``Laboratory Facilities.''
(1) HHS-certified laboratories shall comply with applicable
provisions of any State licensure requirements.
(2) HHS-certified laboratories shall have the capability, at the
same laboratory premises, of performing initial tests for each drug and
drug metabolite for which service is offered, and for performing
confirmatory tests for alcohol and for each drug and drug metabolite for
which service is offered. Any licensee testing facilities shall have the
capability, at the same premises, of performing initial screening tests
for each drug and drug metabolite for which testing is conducted. Breath
tests for alcohol may be performed at the collection site.
(m) ``Inspections.'' The NRC and any licensee utilizing an HHS-
certified laboratory shall reserve the right to inspect the laboratory
at any time. Licensee contracts with HHS-certified laboratories for drug
testing and alcohol confirmatory testing, as well as contracts for
collection site services, shall permit the NRC and the licensee to
conduct unannounced inspections. In addition, prior to the award of a
contract, the licensee shall carry out pre-award inspections and
evaluation of the procedural aspects of the laboratory's drug testing
operation. The NRC shall reserve the right to inspect a licensee's
testing facility at any time.
(n) ``Documentation.'' HHS-certified laboratories and the licensee's
testing facility shall maintain and make available for at least 2 years
documentation of all aspects of the testing process. This 2-year period
may be extended upon written notification by the NRC or by any licensee
for which laboratory
[[Page 460]]
services are being provided. The required documentation shall include
personnel files on all individuals authorized to have access to
specimens; chain-of-custody documents; quality assurance/quality control
records; procedure manuals; all test data (including calibration curves
and any calculations used in determining test results); reports;
performance records on performance testing; performance on certification
inspections; and hard copies of computer-generated data. The HHS-
certified laboratory and the licensee's testing facility shall be
required to maintain documents for any specimen under legal challenge
for an indefinite period.
(o) ``Additional Requirements for HHS-certified Laboratories and
Licensee's Testing Facilities.''
(1) ``Procedure manual.'' Each laboratory and licensee's testing
facility shall have a procedure manual which includes the principles of
each test, preparation of reagents, standards and controls, calibration
procedures, derivation of results, linearity of methods, sensitivity of
the methods, cutoff values, mechanisms for reporting results, controls,
criteria for unacceptable specimens and results, remedial actions to be
taken when the test systems are outside of acceptable limits, reagents
and expiration dates, and references. Copies of all procedures and dates
on which they are in effect shall be maintained as part of the manual.
Superseded material must be retained for three years.
(2) ``Standards and controls.'' HHS-certified laboratory standards
shall be prepared with pure drug standards which are properly labeled as
to content and concentration. The standards shall be labeled with the
following dates: when received; when prepared or opened; when placed in
service; and expiration date.
(3) ``Instruments and equipment.''
(i) Volumetric pipettes and measuring devices shall be certified for
accuracy or be checked by gravimetric, colorimetric, or other
verification procedure. Automatic pipettes and dilutors shall be checked
for accuracy and reproducibility before being placed in service and
checked periodically thereafter.
(ii) Alcohol breath analysis equipment shall be an evidental-grade
breath alcohol analysis device of a brand and model that conforms to
National Highway Traffic Safety Administration (NHTSA) standards (49 FR
48855) and to any applicable State statutes.
(iii) There shall be written procedures for instrument set-up and
normal operation, a schedule for checking critical operating
characteristics for all instruments, tolerance limits for acceptable
function checks, and instructions for major troubleshooting and repair.
Records shall be available on preventive maintenance.
(4) ``Remedial actions.'' There shall be written procedures for the
actions to be taken when systems are out of acceptable limits or errors
are detected. There shall be documentation that these procedures are
followed and that all necessary corrective actions are taken. There
shall also be in place systems to verify all stages of testing and
reporting and documentation that these procedures are followed.
(5) ``Personnel available to testify at proceedings.'' The
licensee's testing facility and HHS-certified laboratory shall have
qualified personnel available to testify in an administrative or
disciplinary proceeding against an individual when that proceeding is
based on positive breath analysis or urinalysis results reported by the
licensee's testing facility or the HHS-certified laboratory.
2.8 Quality Assurance and Quality Control
(a) ``General.'' HHS-certified laboratories and the licensee's
testing facility shall have a quality assurance program which
encompasses all aspects of the testing process including but not limited
to specimen acquisition, chain-of-custody, security, reporting of
results, initial and confirmatory testing, and validation of analytical
procedures. Quality assurance procedures shall be designed, implemented,
and reviewed to monitor the conduct of each step of the process of
testing for drugs.
(b) ``Licensee's Testing Facility Quality Control Requirements for
Initial Tests.'' Because all positive preliminary tests for drugs are
forwarded to an HHS-certified laboratory for screening and confirmatory
testing when appropriate, the NRC does not require licensees to assess
their testing facility's false positive rates for drugs. To ensure that
the rate of false negative tests is kept to the minimum that the
immunoassay technology supports, licensees shall process blind
performance test specimens and submit a sampling of specimens screened
as negative from every test run to the HHS-certified laboratory. In
addition, the manufacturer-required performance tests of the breath
analysis equipment used by the licensee shall be conducted as set forth
in the manufacturer's specifications.
(c) ``Laboratory Quality Control Requirements for Initial Tests at
HHS-Certified Laboratories.'' Each analytical run of specimens to be
screened shall include:
(1) Urine specimens certified to contain no drug;
(2) Urine specimens fortified with known standards; and
(3) Positive controls with the drug or metabolite at or near the
threshold (cut-off).
In addition, with each batch of samples, a sufficient number of
standards shall be included to ensure and document the linearity
[[Page 461]]
of the assay method over time in the concentration area of the cut-off.
After acceptable values are obtained for the known standards, those
values will be used to calculate sample data. Implementation of
procedures to ensure that carryover does not contaminate the testing of
an individual's specimen shall be documented. A minimum of 10 percent of
all test samples shall be quality control specimens. Laboratory quality
control samples, prepared from spiked urine samples of determined
concentration, shall be included in the run and should appear as normal
samples to laboratory analysts. One percent of each run, with a minimum
of at least one sample, shall be the laboratory's own quality control
samples.
(d) ``Laboratory Quality Control Requirements for Confirmation
Tests.'' Each analytical run of specimens to be confirmed shall include:
(1) Urine specimens certified to contain no drug;
(2) Urine specimens fortified with known standards; and
(3) Positive controls with the drug or metabolite at or near the
threshold (cut-off).
The linearity and precision of the method shall be periodically
documented. Implementation of procedures to ensure that carryover does
not contaminate the testing of an individual's specimen shall also be
documented.
(e) ``Licensee Blind Performance Test Procedures.''
(1) Licensees shall purchase chemical testing services only from
laboratories certified by DHHS or a DHHS-recognized certification
program in accordance with the HHS Guidelines. Laboratory participation
is encouraged in other performance testing surveys by which the
laboratory's performance is compared with peers and reference
laboratories.
(2) During the initial 90-day period of any new drug testing
program, each licensee shall submit blind performance test specimens to
each HHS-certified laboratory it contracts within the amount of at least
50 percent of the total number of samples submitted (up to a maximum of
500 samples) and thereafter a minimum of 10 percent of all samples (to a
maximum of 250) submitted per quarter.
(3) Approximately 80 percent of the blind performance test samples
shall be blank (i.e., certified to contain no drug) and the remaining
samples shall be positive for one or more drugs per sample in a
distribution such that all the drugs to be tested are included in
approximately equal frequencies of challenge. The positive samples shall
be spiked only with those drugs for which the licensee is testing.
(4) The licensee shall investigate, or shall refer to DHHS for
investigation, any unsatisfactory performance testing result, and based
on this investigation, the laboratory shall take action to correct the
cause of the unsatisfactory performance test result. A record shall be
made of the investigative findings and the corrective action taken by
the laboratory, and that record shall be dated and signed by the
individuals responsible for the day-to-day management and operation of
the HHS-certified laboratory. Then the licensee shall send the document
to the NRC as a report of the unsatisfactory performance testing
incident within 30 days. The NRC shall ensure notification of the
finding to DHHS.
(5) Should a false positive error occur on a blind performance test
specimen and the error is determined to be an administrative error
(clerical, sample mixup, etc.), the licensee shall promptly notify the
NRC. The licensees shall require the laboratory to take corrective
action to minimize the occurrence of the particular error in the future;
and, if there is reason to believe the error could have been systematic,
the licensee may also require review and reanalysis of previously run
specimens.
(6) Should a false positive error occur on a blind performance test
specimen and the error is determined to be a technical or methodological
error, the licensee shall instruct the laboratory to submit to them all
quality control data from the batch of specimens which included the
false positive specimen. In addition, the licensee shall require the
laboratory to retest all specimens analyzed positive for that drug or
metabolite from the time of final resolution of the error back to the
time of the last satisfactory performance test cycle. This retesting
shall be documented by a statement signed by the individual responsible
for day-to-day management of the laboratory's substance testing program.
The licensee and the NRC may require an on-site review of the laboratory
which may be conducted unannounced during any hours of operation of the
laboratory. Based on information provided by the NRC, DHHS has the
option of revoking or suspending the laboratory's certification or
recommending that no further action be taken if the case is one of less
serious error in which corrective action has already been taken, thus
reasonably assuring that the error will not occur again.
2.9 Reporting and Review of Results
(a) ``Medical Review Officer shall review results.'' An essential
part of the licensees' testing programs is the final review of results.
A positive test result does not automatically identify a nuclear power
plant worker as having used substances in violation of the NRC's
regulations or the licensee's company policies. An individual with a
detailed knowledge of possible alternate medical explanations is
essential to the review of results. This review shall be performed by
the Medical Review Officer prior
[[Page 462]]
to the transmission of results to licensee management officials.
(b) ``Medical Review Officer--qualifications and responsibilities.''
The Medical Review Officer shall be a licensed physician with knowledge
of substance abuse disorders and may be a licensee or contract employee.
The role of the Medical Review Officer is to review and interpret
positive test results obtained through the licensee's testing program.
In carrying out this responsibility, the Medical Review Officer shall
examine alternate medical explanations for any positive test result
(this does not include confirmation of blood alcohol levels obtained
through the use of a breath alcohol anaylsis device). This action could
include conducting a medical interview with the individual, review of
the individual's medical history, or review of any other relevant
biomedical factors. The Medical Review Officer shall review all medical
records made available by the tested individual when a confirmed
positive test could have resulted from legally prescribed medication.
The Medical Review Officer shall not consider the results of tests that
are not obtained or processed in accordance with these Guidelines,
although he or she may consider the results of tests on split samples in
making his or her determination, as long as those split samples have
been stored and tested in accordance with the procedures described in
these Guidelines.
(c) ``Positive Test Results.'' Prior to making a final decision to
verify a positive test result, the Medical Review Officer shall give the
individual an opportunity to discuss the test result with him or her.
Following verification of a positive test result, the Medical Review
Officer shall, as provided in the licensee's policy, notify the
applicable employee assistance program and the licensee's management
official empowered to recommend or take administrative action (or the
official's designated agent).
(d) ``Verification for opiates; review for prescription
medication.'' Before the Medical Review Officer verifies a confirmed
positive result and the licensee takes action for opiates, he or she
shall determine that there is clinical evidence--in addition to the
urine test--of unauthorized use of any opium, opiate, or opium
derivative (e.g., morphine/codeine). Clinical signs of abuse include
recent needle tracks or behavioral and psychological signs of acute
opiate intoxication or withdrawal. This requirement does not apply if
the GC/MS confirmation testing for opiates confirms the presence of 6-
monoacetylmorphine. For other drugs that are commonly prescribed or
commonly included in over-the-counter preparations (e.g.,
benzodiazepines in the first case, barbiturates in the second) and that
are listed in the licensee's panel of substances to be tested, the
Medical Review Officer shall also determine whether there is clinical
evidence--in addition to the urine test--of unauthorized use of any of
these substances or their derivatives.
(e) ``Reanalysis authorized.'' Should any question arise as to the
accuracy or validity of a positive test result, only the Medical Review
Officer is authorized to order a reanalysis of the original sample and
such retests are authorized only at laboratories certified by DHHS. The
Medical Review Officer shall authorize a reanalysis of the original
aliquot on timely request of the individual tested, and shall also
authorize an analysis of any sample stored by the licensee.
(f) ``Results consistent with responsible substance use.'' If the
Medical Review Officer determines that there is a legitimate medical
explanation for the positive test result and that use of the substance
identified through testing in the manner and at the dosage prescribed
does not reflect a lack of reliability and is unlikely to create on-the-
job impairment, the Medical Review Officer shall report the test result
to the licensee as negative.
(g) ``Result scientifically insufficient.'' Additionally, the
Medical Review Officer, based on review of inspection reports, quality
control data, multiple samples, and other pertinent results, may
determine that the result is scientifically insufficient for further
action and declare the test specimen negative. In this situation, the
Medical Review Officer may request reanalysis of the original sample
before making this decision. (The Medical Review Officer may request
that reanalysis be performed by the same laboratory or, that an aliquot
of the original specimen be sent for reanalysis to an alternate
laboratory which is certified in accordance with the HHS Guidelines.)
The licensee's testing facility and the HHS-certified laboratory shall
assist in this review process as requested by the Medical Review Officer
by making available the individual(s) responsible for day-to-day
management of the licensee's test facility, of the HHS-certified
laboratory or other individuals who are forensic toxicologists or who
have equivalent forensic experience in urine drug testing, to provide
specific consultation as required by the licensee. The licensee shall
maintain records that summarize any negative findings based on
scientific insufficiency and shall make them available to the NRC on
request, but shall not include any personal identifying information in
such reports.
Subpart C--Employee Protection
3.1 Protection of Employee Records
Licensee contracts with HHS certified laboratories and procedures
for the licensee's testing facility shall require that test
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records be maintained in confidence, as provided in 10 CFR 26.29.
Records shall be maintained and used with the highest regard for
individual privacy.
3.2 Individual Access to Test and Laboratory Certification Results
Any individual who is the subject of a drug or alcohol test under
this part shall, upon written request, have access to any records
relating to his or her tests and any records relating to the results of
any relevant laboratory certification, review, or revocation-of-
certification proceedings.
Subpart D--Certification of Laboratories Engaged in Chemical Testing
4.1 Use of DHHS-certified laboratories
(a) Licensees subject to this part and their contractors shall use
only laboratories certified under the DHHS ``Mandatory Guidelines for
Federal Workplace Drug Testing Programs'', Subpart C--``Certification of
Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' (53
FR 11970, 11986-11989) dated April 11, 1988, and subsequent amendments
thereto for screening and confirmatory testing except for initial
screening tests at a licensee's testing facility conducted in accordance
with 10 CFR 26.24(d). Information concerning the current certification
status of laboratories is available from: The Office of Workplace
Initiatives, National Institute on Drug Abuse, 5600 Fishers Lane,
Rockville, Maryland 20857.
(b) Licensees or their contractors may use only HHS-certified
laboratories that agree to follow the same rigorous chemical testing,
quality control, and chain-of-custody procedures when testing for more
stringent cut-off levels as may be specified by licensees for the
classes of drugs identified in this part, for analysis of blood
specimens for alcohol, and for any other substances included in
licensees' drug panels.
[54 FR 24494, June 7, 1989, as amended at 56 FR 41927, Aug. 26, 1991; 58
FR 31470, June 3, 1993]