Haw. Code R. § 11-113-18 - Laboratory procedures for urine specimens
(a) When a
shipment of specimens is received, laboratory personnel shall inspect each
package for evidence of possible tampering and compare information on specimen
bottles 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 bottles and the chain of custody forms attached to the
shipment shall be immediately reported to the third party and shall be noted on
the chain of custody form which shall accompany the specimens while they are in
the laboratory's possession.
(b)
Specimen bottles or containers will normally be retained within the
laboratory's accession area until all analyses have been completed. Aliquots
and the laboratory's chain of custody forms shall be used by laboratory
personnel for conducting tests.
(c)
Specimens that do not receive a test within seven days of arrival at the
laboratory shall be placed in secure refrigeration units at temperatures not
exceeding ten degrees Centigrade. Emergency power equipment shall be available
in case of prolonged power failure.
(d) When conducting either screening or
confirmatory tests, each batch of specimens shall contain an appropriate number
of standards for calibrating the instrumentation and a minimum of ten per cent
of controls.
(e) Except for
additional testing to determine the validity of the specimen, no laboratory
shall test for any substance which is not included in a written statement from
the third party specifying the substances to be tested for. Such additional
tests may include the following:
(1)
Creatinine and specific gravity: the specimen is considered "diluted" if the
creatinine concentration is greater than or equal to 2 mg/dl but less than 20
mg/dl and the specific gravity is greater than 1.001 but less than 1.003. The
specimen is considered "substituted" (i.e., the specimen does not exhibit the
clinical signs or characteristics associated with normal human urine) if the
creatinine concentration, is less than 2 mg/dl and the specific gravity is less
than or equal to 1.001, or greater than or equal to 1.020.
(2) Nitrite: the specimen is considered
"adulterated" if nitrite is equal to or greater than 500 mcg/ml.
(3) pH: the specimen is considered
"adulterated" if the pH is less than 3 or equal to or greater than
11.
(f) The screening
test shall use an immunoassay which meets the requirements of the Food and Drug
Administration for commercial distribution, or any other method approved by the
director. The cutoff levels for screening tests of urine specimens shall
include the following:
| (1) | Marijuana metabolites---------- | 50 ng/ml |
| (2) | Cocaine metabolites------------- | 300 ng/ml |
| (3) | Amphetamines1------------------- | 1,000 ng/ml |
| (4) | Opiate metabolites-------------- | 2,000 ng/ml |
| (5) | 6 -Acetylmorphine------------------ | 10 ng/ml |
| (6) | Phencyclidine and metabolite--- | 25 ng/ml |
| (7) | Barbiturates-------------------- | 300 ng/ml |
| (8) | Methaqualone-------------------- | 300 ng/ml |
| (9) | Benzodiazepines----------------- | 300 ng/ml |
| (10) | Propoxyphene-------------------- | 300 ng/ml |
| (11) | Methadone----------------------- | 300 ng/ml |
Cutoff levels in screening tests for other drugs and for using other specimens shall be approved by the director in writing.
(g) All specimens which have
presumptive positive test results shall be confirmed using gas
chromatography/mass spectrometry techniques or any other technique deemed
appropriate by the director. All confirmations shall be by quantitative
analysis.
(h) The cutoff levels for
confirmatory testing of urine specimens shall include the following:
| (1) | Marijuana metabolite2--------- | 15 ng/ml |
| (2) | Cocaine metabolite3------------ | 150 ng/ml |
| (3) | Morphine4---------------------- | 2,000 ng/ml |
| (4) | 6-Acetylmorphine (6-AM)------- | 10 ng/ml |
| (5) | Codeine------------------------ | 2,000 ng/ml |
| (6) | Phencyclidine------------------ | 25 ng/ml |
| (7) | Amphetamine---------------- | 500 ng/ml |
| (8) | Methamphetamine5----------- | 500 ng/ml |
| (9) | Barbiturates------------------- | 200 ng/ml |
| (10) | Methaqualone------------------- | 200 ng/ml |
| (11) | Benzodiazepines---------------- | 200 ng/ml |
| (12) | Propoxyphene------------------- | 200 ng/ml |
| (13) | Methadone---------------------- | 200 ng/ml |
| (14) | Alcohol------------------ | 0.02 gram/100 ml |
Cutoff levels in confirmatory testing for other drugs and for using other specimens shall be approved in writing by the director.
(i) Before any test result is
reported, it shall be reviewed and the test certified as accurate by the
scientific director.
(j) The
laboratory may transmit results and other information to the medical review
officer by various electronic means in a manner designed to ensure
confidentiality of the information. Results may not be provided verbally by
telephone. The laboratory shall ensure the security of the data
transmission.
(k) All records
pertaining to a given specimen shall be retained by the laboratory for a
minimum of two years.
(l)
Laboratories shall retain and place in properly secured long-term frozen
storage the remainder of all positive specimens at minus ten degrees Centigrade
or lower for a minimum of one year all specimens with a positive test result.
Within this one year period the third party 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 one year,
except that the laboratory shall be required to store any specimens for which
it has received notice of a legal challenge for an indefinite period.
(m) A retest is not subject to a specific
cutoff requirement but must provide data sufficient to confirm the presence of
the drug or metabolite.
(n)
Specimens which are negative for the requested substance abuse tests shall be
discarded within one week after the reporting of the negative test result.
1 Screening must significantly detect d-Methamphetamine, d-Amphetamine, MDMA (3,4-methylenedioxymethamphetamine), MDA (3,4-methylenedioxyamphetamine) and MDEA (3,4-methylenedioxyethylamphetamine).
2Delta-Q-tetrahydrocannabinol-9-carboxylic acid
3 Benzoylecgonine.
4 Test for 6-AM when Morphine concentration exceeds 2000 ng/ml.
5Specimen must also contain amphetamine at a concentration equal to or greater than 200 ng/ml.
Notes
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