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ACUTECH™ Blind Performance Test Samples

ACUTECH™ Blind Performance Test Samples

Use Acutech to meet the revised
NRC Regulations Title 10 CFR Part 26.168
– see bottom of page for complete details on this revised regulation.

We have two options for use of this product to meet the above regulations: 


BOTTLED PRODUCT

We send you the control material and you do the rest.

Bottled urine samples are packaged in 60 ml sealed bottles with removable, color-coded labels for easy identification.

These specimens are liquid, require no reconstitution and are stored at refrigerator temperature, until used.

Please see order form for more details.

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TURNKEY OPTION

Send us the necessary forms and information we need in order to submit your blinds and we do it for you.

We fill out the forms, prepare the specimens, and ship them throughout the year. This option ensures that each component of the regulation is met to the letter and saves you the headache of doing it yourself.

Turnkey Process Description

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NRC Regulations Title 10 CFR Part 26.168 Blind Performance Testing  

(a) Each licensee and other entity shall submit blind performance test samples to the HHS-certified laboratory.

(1) During the initial 90-day period of any contract with an  HHS-certified laboratory (not including rewritten or renewed contracts),  each licensee or other entity shall submit blind performance test  samples to each HHS-certified laboratory with whom it contracts in the  amount of at least 20 percent of the total number of specimens submitted  (up to a maximum of 100 blind performance specimens) or 30 blind  performance test samples, whichever is greater.

(2) Following the initial 90-day period, the number of blind  performance test samples submitted per quarter must be a minimum of one  percent of all specimens (up to a maximum of 100) or ten blind  performance test samples, whichever is greater.

(3) Both during the initial 90-day period and quarterly  thereafter, licensees and other entities should attempt to submit blind  performance test samples at a frequency that corresponds to the  submission frequency for other specimens.

(b) Approximately 60 percent of the blind performance test samples  submitted to the laboratory must be positive for one or more drugs or  drug metabolites per sample and submitted so that all of the drugs for  which the FFD program is testing are included at least once each  calendar quarter, except as follows:

(1) Licensees and other entities shall submit blind performance  test samples that are positive for marijuana metabolite at least two  times each quarter; and

(2) In at least two quarters each year, licensees and other  entities shall submit an additional blind performance test sample that  is positive for cocaine instead of the required sample that is positive  for PCP.

(c) The positive blind performance test samples must be positive  for only those drugs for which the FFD program is testing and formulated  at concentrations established in paragraph (g)(2) of this section.

(d) To challenge the HHS-certified laboratory's ability to limit  false negatives, approximately 10 percent of the blind performance test  samples submitted to the laboratory each quarter must be formulated at  the concentrations established in paragraph (g)(3) of this section.

(e) To challenge the HHS-certified laboratory's ability to  determine specimen validity, the licensee or other entity shall submit  blind samples each quarter that are appropriately adulterated, diluted,  or substituted, in the amount of 20 percent of the specimens submitted  that quarter or at least three samples per quarter (one each that is  adulterated, diluted, or substituted), whichever is greater. These  samples must be formulated at the concentrations established in  paragraphs (g)(4) through (g)(6) of this section.

(f) Approximately 10 percent of the blind performance test samples  submitted to the laboratory each quarter must be negative, as specified  in paragraph (g)(1) of this section

(g) Licensees and other entities shall use only blind performance  test samples that have been certified by the supplier to be—

(1) Negative. A negative blind performance test sample may not  contain a measurable amount of a target drug analyte and must be  certified by immunoassay and confirmatory testing;

(2) Drug positive. These samples must contain a measurable amount  of the target drug or analyte in concentrations ranging between 150 and  200 percent of the initial cutoff values and be certified by immunoassay  and confirmatory testing to contain one or more drug(s) or drug  metabolite(s);

(3) A false negative challenge. This blind performance test sample  must contain a measurable amount of the target drug or analyte in  concentrations ranging between 130 and 155 percent of the initial cutoff  values;

(4) Adulterated. The adulterated blind performance test sample  must have a pH of less than or equal to 2, or greater than or equal to  12, or a nitrite or other oxidant concentration equal to or greater than  500 mcg/mL, equal to or greater than 50 mcg/mL chromium  (VI)-equivalents, or a halogen concentration equal to or greater than  the LOD. Blind performance test samples for other adulterants must have  adulterant concentrations equal to or greater than (or equal to or less  than, as appropriate) the initial cutoff levels used by the licensee's  or other entity's HHS-certified laboratory;

(5) Dilute. The dilute blind performance test sample must contain a  creatinine concentration that is equal to or greater than 5 mg/dL but  less than 20 mg/dL, and the specific gravity must be greater than 1.0010  but less than 1.0030; or

(6) Substituted. The substituted blind performance test sample  must contain less than 2 mg/dL of creatinine, and the specific gravity  must be less than or equal to 1.0010, or equal to or greater than  1.0200.

(h) In order to ensure that blind performance test samples  continue to meet the criteria set forth in paragraph (g) of this  section, licensees and other entities shall—

(1) Ensure that all blind performance test sample lots are placed  in service by the supplier only after confirmation by an HHS-certified  laboratory, and for no more than 6 months;

(2) Ensure that the supplier provides the expiration date for each  blind performance test sample to ensure that each sample will have the  expected value when it is submitted to and tested by a laboratory; and

(3) At a minimum, require the supplier to check each open lot  bi-monthly (i.e., every two months) to ensure that samples remaining in  the lot do not fall below 130 percent of the initial cutoff test  concentration established by the assay manufacturer. Thus, for example, a  lot that was certified by an HHS-certified laboratory at 155 percent of  the manufacturer's assay cutoff level, and was reported by the  licensee's or other entity's HHS-certified laboratory to be at or above  130 percent of that standard is acceptable. A test that indicated a  result below 130 percent of that standard would be unacceptable.  Licensees and other entities shall discard blind performance test  samples from any lot that is outside of these parameters and may not use  any further samples from that lot.

(i) Licensees and other entities shall ensure that each blind  performance test sample is indistinguishable to laboratory personnel  from a donor's specimen, as follows:

(1) The licensee or other entity shall submit blind performance  test samples to the laboratory using the same channels (i.e., from the  licensee's or other entity's collection site or licensee testing  facility, as appropriate) through which donors' specimens are sent to  the laboratory;

(2) The collector and licensee testing facility personnel, as  appropriate, shall use a custody-and-control form, place fictional  initials on the specimen bottles' labels/seals, and indicate for the MRO  on the MRO's copy that the specimen is a blind performance test sample;  and

(3) The licensee or other entity shall ensure that all blind  performance test samples include split samples, when the FFD program  includes split specimen procedures.       [73 FR 17216 Mar. 31, 2008]

* Source NRC website:       http://www.nrc.gov/reading-rm/doc-collections/cfr/part026/part026-0168.html