General Laboratory Information

Transcription

1 General Laboratory Information 2007

2 Table of Contents I. Company Overview One Source Toxicology Laboratory II. One Source Toxicology Laboratory Work Flow III. SAMHSA Certification Information Certification Letter Current Inspection Report Proficiency Test Report List of Approved Laboratories One Source Toxicology Listing in Federal Register College of American Pathologists - Forensic Urine Drug Testing Drug Enforcement Administration Clinical Laboratory Improvement Amendments Texas Department of Public Safety State of Oklahoma License IV. Custody and Control Forms Department of Transportation Non-Department of Transportation Online Custody and Control Form V. Result Reporting Summary Detail Report Statistical Reports Scanned Custody and Control Form Performance Timeline VI. Certification of Insurance VII. Client References VIII. Glossary of Terms 2

3 Company Overview Laboratory History One Source Toxicology Laboratory Inc. is a privately held, multi-million dollar national forensic drug and alcohol-testing laboratory. The laboratory began operations in 1999 as a result of the merger between The University of Texas SAMHSA Laboratory and Employer Support Services Inc. Today the company is a full-service laboratory now receiving specimens throughout the United States and several foreign countries, therefore making it a leader in the industry. One Source Toxicology Laboratory continues its affiliation with the University of Texas Medical School by offering medical and graduate students training in the field of forensic toxicology. Certifications Laboratory operations and results are certified by several accrediting agencies. Department of Health and Human Services Administration / Substance Abuse Mental Health Services Administration (SAMHSA) Public Health Services Act - Clinical Laboratory Improvement Amendments (CLIA) Full Service Toxicology Laboratory Identification Number 45D The College of American Pathologist - Forensic Urine Drug Testing Texas Controlled Substance Registration Certificate - Texas Department of Public Safety Texas Department of Public Safety Accreditation as a Forensic Urine analysis Laboratory Oklahoma State Department of Health Drug Enforcement Administration (DEA) Drug & Alcohol Testing Industry Association (D.A.T.I.A) Services One Source Toxicology Laboratory provides substance abuse urinalysis screening and Gas Chromatography Mass Spectrometry confirmation testing. Additionally, One Source Toxicology Laboratory provides these services: Alcohol testing Sample validity testing On-site sample collection Courier services Internet Reporting Internet Chain of Custody documentation Result Turn-Around Time One Source Toxicology Laboratory has the shortest specimen processing time coupled with the fastest reporting methods in the industry. Over 90 percent of the results are reported to our clients within 24

4 hours from the time the specimen was collected. O n e S o u r c e T o x i c o l o g y L a b o r a t o r y I n c. Client Services One Source Toxicology Laboratory has 46 employees working around the clock to service our clients nonstop. Seven employees have ten, or more, years of experience working in a Substance Abuse Mental Health Services Administration (SAMHSA) certified laboratory. A client service specialist will assist you with questions regarding specimen shipments, test results, account set-up, and supply orders. The Client Service Department is available by telephone from 6:30 a.m. to 5:00 p.m. Central Standard Time, Monday through Friday. In addition, our laboratory manager and technical director are also available for additional consultation. Chain of Custody Indisputable Chain of Custody documentation is clearly as important as valid, reproducible analytical results. One Source Toxicology Laboratory supplies forensic urine collectors with unique bar-coded custody and control forms, collection cups, security seals, collection instructions, and shipping containers. Internet Chain of Custody documentation is the preferred method for transmitting secure, accurate, and instant donor information. A unique bar-coded number assigned by the collector identifies the specimens with the custody and control form; therefore eliminating any confidentiality issues. Specimen Shipping A local courier service transports specimens within 150 miles of the Laboratory. Alternate shipping methods include counter-to-counter direct flights from major metropolitan areas or DHL Overnight Next AM Service. Statistical Reporting (DOT) One Source Toxicology Laboratory will provide a bi-annual statistical summary of all DOT urinalysis testing by account. The report shall include initial screening and confirmation data, the number of specimens reported, the number of specimens screened, and the number confirmed non-negatives for the five required analytes. The report will not include any personal identifying information. Collection Supplies One Source Toxicology Laboratory ships urine collection supplies to agreed upon collection locations. Supply kits include collection instructions, sealed and certified drug-free polypropylene collection bottles, tamper proof seals, chain-of-custody forms, absorbent materials, shipping containers, temperature-measuring devices, and shipping instructions.

5 Specimen Storage O n e S o u r c e T o x i c o l o g y L a b o r a t o r y I n c. Specimens are immediately delivered to the laboratory s accessioning department to be prepared for the screening process. Specimens are stored at room temperature before and during testing. After a specimen screens negative, it retained at room temperature for two days until it is discarded. Specimens that screen non-negative are placed in refrigeration during the confirmation process. If confirmed non-negative, a specimen is maintain in secure frozen (-20 C) storage for one year. Adulterated and litigated specimens are kept for one year, or as long as necessary. Records All records associated with the collection, transfer and testing of a specimen are maintained for a period of at least two years. General Security and Access One Source Toxicology Laboratory provides several layers of physical security. The building s outside perimeter is locked 24 hours a day. Audible alarms are installed on the outside doors. If a door is opened without the use of a security card and finger print verification, an alarm will sound and an automated electrical record will document the event. A PC-controlled magnetic identification card and fingerprint recognition scanner system controls external and internal doorway passage. The personnel are limited to specific areas of the laboratory according to the identification cards and fingerprint recognition scanner. The PC-controlling system records the time, date, portal of entry, and the identity of each employee entering a secure area. This PC is located in the computer offices of the laboratory. Access to each area of the laboratory is limited to staff who have a strict functional need for such access. The interior walls in the laboratory area extend to the roof for additional security. Computer Security The main computer system utilizes a log-on password system with individualized personal keys. This allows the system to track each employee and maintain audit trails of activities. This feature restricts access to specific processes and files within the computer. Maintenance and Management of Quality Control The cornerstone to a defensible drug and alcohol-testing program is establishing and maintaining high operation standards. One Source Toxicology Laboratory utilizes state-of-the-art testing equipment and is monitored by a rigid Quality Control & Quality Assurance program. The One Source Toxicology Laboratory Director is responsible for our quality control program. The program includes preparing monthly data reviews, preparation of blind sample quality control, control and

6 standard preparation, and linearity determination. The quality control program is monitored by: 1. Internal Blind Quality Control - These samples are prepared in-house with known levels of drugs. 2. External Blind Quality Control- These samples are prepared by our existing clients and shipped to the laboratory as specimen donors. This procedure follows the forensic testing protocol from shipping to storage. 3. Open Quality Control - These samples are tested outside assayed controls, which constitute 10 percent of the screening run. Drug groups with two calibrating standards control the confirmation procedures. Those standards include; one low control one high control; one non-negative control and one negative control. The linearity is verified by the use of the standards, low and high control. 4. Proficiencies - One Source Toxicology Laboratory participates in the Department of Health and Human Services testing proficiency program and the College of American Pathology/Forensic Urine Drug Testing (CAP/FUDT) Program. 5. Outside Quality Control - On a monthly basis, an outside assayed control is extracted for each drug group to secure as a check on our calibrating standards, which are prepared in-house. If any discrepancies are noted, our in-house standards are sent to another laboratory for verification. 6. Reagent Standards and Calibrations - All reagents used in screening and confirmation methods are verified against reagents in use and compared to known reference standards before being used on patient runs. Litigation Support One Source Toxicology Laboratory provides a complete litigation support package. The following are examples a DOT and Non-DOT litigation documentation packet:

7 Department of Transportation Triangle Institute 3040 Cornwallis Dr. Research Triangle Park, NC O n e S o u r c e T o x i c o l o g y L a b o r a t o r y I n c. To whom it May Concern: This data packet contains all of the data pertinent to specimen ID ########, which was reported as Positive for Carboxy-THC (marijuana metabolite), and contains 26 sequentially numbered pages. The packet contains a copy of the Federal Custody and Control Form (CCF) which was filled out by the collector when the specimen was collected, documents the specimens receipt at the laboratory and contains the final results of the drug test. This Federal CCF is considered an external chain of custody form only. Upon receipt of the specimen, it is placed in a batch with a maximum of 58 other Federally regulated specimens and internal batch chain of custody forms are utilized for the duration of the specimen s residence in the laboratory (i.e. until disposal). The packet contains two sets of data, the initial test data and the confirmatory test data. In front of every set of data is the batch custody and control form that indicates the chain of custody for both the entire batch of specimens and batch of aliquots containing the above listed sample during each testing phase. The initial tests are a set homogenous immunoassay (HIA) tests that utilize antibody recognition to determine semi-quantitative levels for each drug whose testing is required by Department of Transportation (DOT) regulations. The HIA tests are especially useful for determining which specimens do not contain the drug in question. Specimens whose initial test quantitation is above the cutoff established by the DOT are considered presumptively positive and are taken to confirmatory testing. During the initial testing phase specimen validity tests (SVT) are also performed. These tests consist of colorimetric tests for ph, and creatinine. Creatinine is a compound produced by bone matter that is excreted into the urine at high quantities. According to DOT guidelines, low amounts of creatinine in a urine specimen (< 20.0 mg/dl) may indicate that the specimen is dilute or ( 5.0) inconsistent with normal human urine. The specific gravity of any specimen with a creatinine quantity < 20.0 is performed as a SVT confirmatory test for either of these cases. The confirmatory test for presumptively positive specimens is performed using various extraction techniques to remove drugs from the specimen and put them in organic matrices. Gas chromatography mass spectrometry detection or GC/MS is then performed on the organic matrices to determine the quantitation of drug in the sample. GC/MS is a method that ionizes molecules and guides them through mass selective paths. This ionization process breaks some of the molecules apart (but not all) allowing the instrument to measure the mass and quantities of both the parent molecule and the molecule fragments in a similar way to looking at a puzzle completed and its various pieces when it is apart. Thus GC/MS gives excellent quantitation of the drugs being tested but also exceptional compound identification in a single test. Steve Harris, RP 7

8 Non-Department of Transportation O n e S o u r c e T o x i c o l o g y L a b o r a t o r y I n c. To Whom It May Concern: Enclosed is the Litigation Package Donor Id Number ###-##-#### Requisition Number , Specimen I.D. Number , and Accession Number The items requested are labeled as described below: 1. Laboratory Qualification Statement: Enclosed is a copy of the Federal Register, which lists One Source Toxicology as a SAMHA/HHS Certified Laboratory. 2. Personal Qualification Statement: A copy of my curriculum vitae is included. 3. Drug Testing Custody and Control Form: A copy of the original Custody and Control Form is included. Note: the Accession Number ######, also appears in the right bottom portion of the original chain of custody. 4. A signed report generated by the laboratory. 5. Initial Screening Documents: Copies of the initial screening batch work list, instrument data and chain of custody documentation for both the specimens and aliquots contained in the batch are included. An initial result of positive for Delta-9-THC-CA. Data includes calibration, applicable controls and patient data. 6. GC/MS Confirmation Documents: Copies of the GC/MS batch work list, instrument data and chain of custody documentation for both the specimens and aliquots contained in the confirmation batch are included. The sample at issue is identified by the Accession Number ###### and confirmed positive for Delta-9-THC-CA at 14 ng/ml. Data includes calibration, applicable controls and patient data. All copies submitted with this Litigation Package are certified to be true and correct by my initials in the bottom right hand corner. All original documents are maintained in the locked secured record storage section of the Laboratory. If there are any questions or additional information required please contact me directly at (713) or (888) Sincerely, Steve Harris, RP

9 One Source Toxicology Laboratory Workflow Receiving Specimens at One Source Toxicology Upon arrival, the specimens and custody and control form documentation are placed in a secure location with limited access to designated persons. An accessioning technician receives the specimen and verifies that the unique bar-coded number on the specimen corresponds with the bar-coded number on the custody and control form documentation. The accessioning technician inspects the specimen for any tampering. If the technician determines any discrepancies with the specimen and documentation, the laboratory will notify the Drug Program Coordinator immediately. Testing is suspended at this point. The technician signs the chain of custody transport document acknowledging the transfer of custody for the specimen. A double entry system is used to enter into the laboratory computer the specimen identification number, employer name, and test request. The specimen and custody and control form are tagged with a unique bar-coded laboratory accession number generated by the laboratory. The bar-coded tube identifies the specimen during the automated screening process. This state-of-the-art bar coding entry system, combined with a unique to the industry proprietary software program, allows One Source Toxicology s Quality Control Technologist to review all quality control data before the client s results are released. Internal Chain of Custody An internal chain of custody document is generated for each forensic specimen. All handling of the sample will be documented on this form. The original sample container remains in a secure location at all times. If duplicate sample bottles were collected and transported, the seal is broken on only one specimen sample. This sample is used for the analysis. During analysis the working specimen bottle is always maintained in a secure location. Aliquots, or portion of the sampler, are removed and used for the analysis procedures. The entire sample is never used to conduct analysis. The work sheets serve as chain of custody documents for the aliquots. Upon completion of testing, the internal chain of custody documentation is placed in the file folder for forensic samples with an attached copy of the original chain of custody document.

10 Samples screening negative either contain no drugs or the drug(s) presence is below the cut-off detection level. Negative samples are routinely maintained for two days. Samples that screen non-negative are handled in the following manner: Following a non-negative screen, another aliquot from the working sample is taken from locked storage and prepared for the confirmation testing process. After non-negative confirmatory analysis, samples are placed in a negative 20-degree frozen storage for one year. The specimens are discarded after one year of the confirmation result. These samples may be retained for an additional time period by prior agreement with the client. Custody and Control Form The custody and control form is a written document that accounts for the integrity of each urine specimen. The form tracks handling, storage from the point of specimen collection, and the final disposal of the specimen. One Source Toxicology Laboratory currently uses a custom form for Non-Department of Transportation clients and a Federally approved Custody and Control form for Federal Workplace Programs. Validation of Specimens The collection site personnel check the integrity of specimens by: Measuring the temperature of the specimen with a device pre-affixed on the specimen bottle. Measuring specimen volume to ensure there is at least 30 ml of urine. Inspecting the specimen samples for signs of tampering. After receiving and documenting the specimens at the laboratory, One Source Toxicology Technicians check the specimen by performing a validity test during the screening process to measure: Creatinine Specific Gravity ph General Oxidizing Substances Testing Initial screens are performed on the automated Olympus instrument system, utilizing enzyme immunoassay procedures. Confirmation of non-negative results are by gas chromatography / mass spectrometry (GC/MS), considered by Substance Abuse Mental Health Services Administration and the courts to be the only definitive confirmation method at this time. 10

11 Screening Procedures Certifying agencies such as Substance Abuse Mental Health Services Administration and the College of American Pathologists clearly mandate that laboratories performing drug screens on employees use methodologies with the sensitivity of an immunoassay. The analytical principle of an immunoassay is based upon an affinity of an antibody in the testing reagent for a specific drug, which may be present in the test specimen. Each drug group requires a separate analysis. Analysis is performed on an Olympus 5400 automated analyzer. Samples are bar-coded to minimize the possibilities of a sample mix-up and to shield the identity of the subject providing the urine sample. The combination of the immunoassay system on an automated instrument provides a highly reliable and efficient analysis. Screening procedures include a minimum 10 percent of known specimens to be tested for proper machine calibration, blank specimens, and an internal blind specimen to ensure Quality Control and Quality Assurance (QC/QA). Screens will always report a non-negative result if enough of the specific drug is present. For this reason, the screening process is regarded as a step to eliminate the true negative samples from samples that require further testing. Those samples, which screen non-negative, are considered as presumptive non-negative only until a second, more definitive test is performed. Confirmation Procedures All confirmation procedures are performed using Hewlett Packard gas chromatography / mass spectrometers as required by SAMHSA. The suspected drug is separated from the biological matrix (human urine) by an extraction technique. The final extract is subjected to GC/MS analysis. GC/MS is a highly specific system, which separates the drugs from one another and provides a fingerprint which conclusively identifies a drug. The drug group is analyzed separately and each analysis run employs calibration. The blank and quality control samples are tested to ensure the validity of the assay. A certifying scientist reviews each confirmatory analysis, the screening data, and the associated chain of custody documents for approval before releasing a non-negative result. In keeping with One Source Toxicology s goal to produce the highest level of analysis, the personnel take the scientifically acknowledged technology of GC/MS one step further by preparing a solvent between each patient specimen. With this technique, you can be absolutely assured of eliminating potential carryover between donors with high non-negatives. 11

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23 Chain of Custody The chain of custody is the process of tracking the specimen from the point of collection until its final disposal. This process is initiated when the custody and control form is filled out by the collector. The collector seals the custody and control form with the specimen before sending it to the laboratory. Once the specimen arrives at the laboratory, an accessioning technician enters the specimen ID number located on the bottle prior to screening process. When the client accesses the account online, the specification ID number, the donor s name, and social security number are accompanied with the data. 23

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25 These are the four carbon copies of the DOT custody and control form 25

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27 Non-DOT Custody and Control Form The non-dot custody and control form is a four-part document. The original copy accompanies the specimen to the laboratory for analysis. The green copy is given to the donor. The pink copy is sent to the medical review officer. The blue copy of the custody and control is retained by the collector. 27

28 file:///volumes/lexar%20media/cocform.htm Specimen ID: I One Source Toxicology NON D.O.T. Chain of Custody Form (Do not use this form for D.O.T. collections) 1213 Genoa Red Bluff Pasadena, Tx »STEP 1: To be completed by Collector or Employer Representative Acct #: Sub Acct: A. Employer Name, Address and I.D. no. B. MRO Name and Address Company: MRO Name: Address: Address: City:, City:,»STEP 2: To be completed by Collector Donor Name: Donor SSN or ID#: ---- Reason for Test: Periodic Donor Phone #: ---- Test Panels THC Cutoff Alcohol (add on) Drug Screen (P2) with Confirm 20 ng/ml Urine 5 Panel non-dot (P3) 50 ng/ml Blood Profile: 100 ng/ml Miscellaneous < tr> GC/MS only (P4) Drug THC Amphetamines Cocaine Opiates Barbs PCP Methaqualone Methadone Benzo Propox»STEP 3: To be completed by Collector -Specimen temperature read within 4 min. of collection X Yes No Specimen temperature within range: X Yes, 90ºF/32º-38ºC No, Record temperature here:»step 4: To be completed by Collector and Donor - Collector affixes bottle seal to bottle(s). Collector dates seal(s). Donor initials seal(s).»step 5: To be completed by Collector Collection Site Location: Phone: Split Collection Yes X Name: No Address: City:, Remarks: I certify that the specimen identified on this form is the specimen presented to me by the donor, that it bears the same specimen identification number as that set forth above, and that it has been collected, labeled and sealed as in accordance with applicable forensic requirements. Signature of Collector (PRINT) Collector's Name (First, MI, Last) 5:01:46 PM Time 03/23/06 Date (mo/day/yr.) Specimen Bottle(s) Released To: Name of Delivery Service transferring specimen to Lab»STEP 6: To be completed by Donor. I authorize the collection of this specimen for the purpose of a drug screen. I acknowledge that the specimen container(s) was/were sealed with a tamper proof seal(s) in my presence, and that the information provided on this form and on the label(s) affixed to the specimen container(s) is correct. I authorize the laboratory to release the results of the test to the company identified on this form or it's designated agents. (PRINT) Donor's Name (First, MI, Last) Signature of Donor Initials 03/23/06 Date(Mo./Day/Yr.)»STEP 7: To be completed by Lab. Signature of Accessioner Received at Lab: Specimen Bottle(s) Released To: (PRINT) Accessioner's Name (First, Mi, Last) Pouch Intact upon Receipt? Yes No Date (mo/day/yr.) Seals Intact upon Receipt? Yes No Blood Specimen Received 28

29 From the One Source Toxicology website, an employer can access an account to activate chains online, order supplies, check results, and get summary reports. 29

30 07/07/ :27 PM One Source Toxicology 1213 Genoa Red Bluff Ph: Pasadena, Texas Fx: Toll Free: Result Form Client: INDIVIDUAL Reason: PRE-EMPLOY Address: Spec ID: City:, Req #: Attn: Acc #: Profile: Donor: GRAY, LARRY Donor ID: Coll Name: Coll Site: DSE Sub Acct: Coll Phone: Test Name: SCREEN W/CONFIRM Result: POSITIVE Collected: 08/16/01 Received: 08/16/01 Reported: 8/17/2001 SCREEN CUTOFF GC/MS CUTOFF DRUG RESULT NG/ML NG/ML CARBOXY-THC (MARIJUANA-MET) POSITIVE 20 5 AMPHETAMINE/METHAMPHETAMINE NEGATIVE BENZOYLECGONINE (COCAINE-MET) NEGATIVE OPIATES (CODEINE/MORPHINE) NEGATIVE PHENCYCLIDINE "PCP" NEGATIVE BARBITURATES NEGATIVE BENZODIAZEPINES NEGATIVE PROPOXYPHENE NEGATIVE METHADONE NEGATIVE METHAQUALONE NEGATIVE CONFIRMED POSITIVE FOR DELTA-9-THC-CA BY GC/MS (6 ng/ml) The preceding result has been reviewed and is certified to be as reported. Page 1 of 2 30

31 07/07/ :29 PM MRO Associates / test mro 525 N Sam Houston Pkwy Houston, Tx Phone: Fax: MRO Result Form Company: FORWARD EDGE - NIDA Reason: PRE-EMPLOY Attn: WAYNE KELLER, M.D. Sub Acct: TX * Patient: , Patient ID: Date Rep: 4/6/2001 Test Name: NIDA SCREEN CCF Reviewed & Received: Coll. Date: 09/18/00 Coll. Site: U.S. HEALTHWORKS I have reviewed laboratory test results following 49 CFR part 40 guidelines for urinalysis drug testing. Sample # was screened for: CARBOXY-THC (MARIJUANA-MET), AMPHETAMINE/METHAMPHETAMINE, BENZOYLECGONINE (COCAINE-MET), OPIATES (CODEINE/MORPHINE), PHENCYCLIDINE "PCP" Therefore, my determination for this test is: POSITIVE Comments: CONFIRMED POSITIVE FOR BENZOYLECGONINE/COCAINE METABOLITE BY GC/MS If you have any questions, please contact this office. Sincerely, Mark Connors 04/06/01 Verified Medical Review Officer CCF Received and Reviewed: This test was performed by One Source Toxicology Laboratory Page 1 of 1 31

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34 As an internal audit, One Source Toxicology will measure the time it takes to complete a test and get the result to the client. This is measured from the time of the collection until the time it is reported to the client. 34

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36 References Kellogg Brown & Root Sharon Madden 4100 Clinton Drive, Building # 3 Houston, TX (713) West Gulf Maritime Association Stan Polis 1717 East Loop, Suite 200 Houston, TX (713) Port of Houston Authority Melanie Sherman 111 East Loop North Houston, TX (713) United States District Court US Pretrial Services Office Jesse Montano, Sr. 727 E. Durango Blvd., Room 636 San Antonio, TX (210) Montgomery County Pat Hamm 2245 North First Street Conroe, TX (936) State of Texas Lynn Brown 1711 San Jacinto Austin, TX (512) Zachry Construction Steve Sells 527 Logwood San Antonio, TX (210) W.S. Bellows Construction Corp. Tommy Lee 1906 Afton Houston, TX (713) Harris County Vicki Adams 49 San Jacinto Suite 630 Houston, TX (713) Williamson County Rick Zinsmeyer P.O. Box 251 Georgetown, TX (512)

37 Glossary of Drug Testing Terms Accuracy Ability to get the correct (or true) result. Adulterated If an exogenous substance or an endogenous substance is at a higher concentration than the normal physiological concentration is present in the specimen. Aliquot A portion of a specimen used for testing. Analyte Drug to be measured Anti-Drug Program Manager (ADPM) An individual appointed by the employer to coordinate and administer the consortium Anti-Drug Program (Policy/Plan). BAT Breath Alcohol Technician certified to use an Evidential Breath Testing device (EBT). Blank Urine specimen with no detectable drugs, routinely analyzed to ensure that no false-nonnegative results are obtained or blank (urine) may be added to dilute a sample with very high levels of drug. Blind Sample Submitted to the laboratory as a routine specimen and may be non-negative or negative. Chain of Custody A paper trail for a sample documenting the handling for each step of the collection, analysis, and certification process. CLIA Certified Laboratory The Clinical Laboratories Improvement Amendments of 1988 was established by the Department of Health and Human Services to regulate clinical laboratories performing analytical tests or diagnostic tests on human samples. One Source Toxicology Laboratory was CLIA certified in July Collection Site A designated location for the purpose of providing a specimen of urine, breath, or saliva to be analyzed for the presence of abused substances. Collection Site Person A person who instructs and assists donors at the collection site. They receive and make an initial examination of the urine specimen provided by the donor. The collection procedures should be consistent with the guidelines set forth by the Department of Transportation (DOT). Concentration Amount of a drug in a unit volume of biological fluid, expressed as weight/volume. Urine concentrations are usually expressed either as nanograms per milliliter (ng/ml), micrograms per milliliter (µg/ml), or milligrams per liter (mg/l). * There are 28,000,000 micrograms in an ounce and 1,000 nanograms in a microgram. Confirmation A second test by an alternate chemical method (GC/MS) to positively identify a drug or metabolite. Confirmations are performed once an initial screen determines a presumptive nonnegative. Consortium Program Manager (CPM) An individual designated by the Consortium Administrator to manage the mandated anti-drug program (Policy) and works closely with the Anti-Drug Program 37

38 Administrator. Covered Employee Applies to those employees who are mandated by the 49 CFR part 40, Procedures for Transportation Workplace Drug Testing Programs. The department regulates six modes of transportation through different agencies. o Federal Aviation Administration o Federal Highway Administration o Federal Motor Carrier Safety Administration o Federal Railroad Administration o Federal Transit Administration o Pipeline and Hazardous Material Safety Administration Creatinine A normal component of human urine excreted by the body as a by-product of muscle metabolism. The concentration of creatinine is used to determine if a sample is dilute. Less than 20 milligrams/100 ml (20 mg/dl) of urine is considered dilute. Cross-Reacting Substances In immunoassays, refers to substance that cross react with antibodies of a specific drug (for example, THC). These cross-reacting substances may cause an immunoassay to appear non-negative for the drug being measured. Cut-off Level (threshold) A value serving as a pre-determined breakpoint (or cut-off point) for declaring a urine result non-negative. Detection Limit Lowest concentration of a drug that can reliably be detected. DHHS Department of Health and Human Services Dilute If the creatinine is <20 mg/dl and the specific gravity is <1.003, unless the criteria for a substituted specimen are met. Department of Transportation (DOT) Any agency of the United States Department of Transportation administering regulations requiring compliance with 49 CFR Part 40. Drug Test/Screen A term use for testing or screening of body fluids for the presence of abused substances. Employee An individual being tested. The term is synonymous with donor. Employer An entity employing one or more employees. Employer includes an industry consortium or joint enterprise comprised of two or more employing entities, but no single employing entity is relieved of its responsibility for compliance with this part by virtue of participations in such a consortium or joint enterprise. False Negative A result in an analysis of a sample that indicates the absences of a drug that is actually present. False Non-negative (positive) A result in an analysis of a sample that indicates the presence of a drug that is actually not present. 38

39 Gas Chromatography / Mass Spectrometry (GC/MS) A second, more definitive test, to determine the presence of a substance or metabolite. This test is dependent of the initial Immunoassay Screen and uses a different methodology and chemical principals. This test uses a molecular fingerprint of the parent drug or metabolite. GC/MS is the only approved method by federal agencies to confirm cocaine, marijuana, opiates, amphetamines and phencyclidine for federal employees. Immunoassay Screen An initial screen to separate negative samples from further consideration. Samples testing non-negative are considered presumptive non-negative. Impairment A condition that renders an employee incapable of performing duties in a safe or productive manner. Impairment may be notable to fellow analytical response or alter the analytical result. Interfering Substance A substance other than the analyte that gives a similar analytical response or alters the analytical response. Metabolite A compound produced as a result of chemical changes of a drug in the body. The metabolic process is the normal process by which the body eliminates substances ingested, injected, or absorbed. Nanograms per Milliliter (ng/ml) A unit of measurement that equates the nanograms per milliliter of substance or metabolite. One nanogram = 1 billionth of a gram NHTSA CPL National Highway Traffic Safety Administration Conforming Products List Phamacodynamics The study of the relationship of drug concentration to drug effects. Pharmacokinetics the study of the time course of the processes of absorption, distribution, metabolism, and excretion a drug undergoes in the body. Precision Ability to get the same result between repeated measurements. Presumptive Non-negative Sample which has been flagged as non-negative by screening but which has not been confirmed through GC/MS. Proficiency Testing Specimen A specimen whose expected results are unknown to anyone in the laboratory, submitted by an external agency, and later revealed to the laboratory as an aid to laboratory improvement and/or assessment. Quality Assurance (QA) Practices that assure accurate laboratory results and reporting. Quality Control (QC) Techniques used to detect errors, which can cause deterioration in the quality of laboratory results. Control material most often refers to a specimen, the expected results of which are known to the analyst that is routinely analyzed to ensure the expected results are being obtained. Qualitative Test Chemical analysis to determine the amount of proportions of am mixture. Rejected Specimen A specimen that was received by the testing laboratory, but was cancelled because it failed the chain of custody protocol. Failures in protocol include tampering, adulteration, breakage or some other reason that would place the integrity of a specimen in jeopardy. 39

40 Substance Abuse and Mental Health Services Administration certified laboratories - The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). Secretary The Secretary of the Department of Transportation or the Secretary s designee. Sensitivity The detection limit expressed as a concentration of the analyte in the specimen. Shipping Container A tamper-sealed container used to transfer specimens and associated documentation to the laboratory. Specificity Quality of an analytical technique that tends to exclude all substance by the analyte from affecting the result. Specimen Bottle A bottle which after being labeled and sealed according to 49 CFR Part 40, used to transport a urine specimen to the laboratory. Substituted Specimen A specimen not consistent with normal human urine. The creatinine is less than 20 mg/dl and has a specific gravity of or less. Split Specimen A specimen divided and submitted to the analyst, unknown, as two different specimens with different identifications. Standard Authentic sample of the analyte of known purity, or a solution of the analyte of a known concentration. Substance Abuse The over indulgence of alcohol, prescription drugs, over the counter drugs, or illicit drugs in amounts hazardous to an individual s health. 40