The U.S. Mandatory Guidelines for Federal Workplace Drug Testing Programs: current status and future considerations

The U.S. Department of Health and Human Services (HHS) drug testing standards were published in 1988 and revised in 1994, 1998, and 2004. In 2004, significant revisions defining, standardizing, and requiring specimen validity testing on Federal employee donor urine specimens were included. In a separate notice, HHS proposed to establish scientific and technical guidelines for the Federal Workplace Drug Testing Program to: (1) permit laboratory testing of hair, oral fluid, and sweat patch specimens in addition to urine specimens for marijuana, cocaine, phencyclidine, opiates (with focus on heroin), and amphetamines [including methylenedioxymethamphetamine (MDMA), methylenedioxyethamphetamine (MDEA), methylenedioxyamphetamine (MDA)]; (2) permit use of on-site point of collection test (POCT) devices to test urine and oral fluid at collection sites; (3) permit use of instrumented initial test (screening only) facilities [IITF] to quickly identify negative specimens; and (4) add training requirement for collectors, on-site testers, and MROs. This proposal was published in the Federal Register on 13 April 2004, with a 90-day public comment period. The Substance Abuse and Mental Health Services Administration, HHS, reviewed those comments and is preparing the Final Notice that will define the requirements for such testing, including: specimen collection procedures, custody and control procedures that ensure donor specimen identity and integrity, testing facility, initial and confirmatory test cutoff concentrations, analytical testing methods, result review and reporting, evaluation of alternative medical explanations for presence of drug or metabolite in the donor's specimen, and laboratory certification issues. Voluntary pilot performance testing (PT) programs for each specimen type are on-going since April 2000 to determine how to prepare PT materials for specimens other than urine to evaluate laboratories' ability to routinely achieve accuracy and precision required. Certification programs will be developed using the current urine drug testing National Laboratory Certification Program model. The addition of accurate and reliable workplace drug testing using hair, oral fluid, and sweat patch specimens will complement urine drug testing, and aid in combating industries devoted to suborning drug testing through adulteration, substitution, and dilution. For example, hair testing may detect chronic drug use for up to 90 days and be useful in pre-employment situations; oral fluid testing may detect drug use in past hours and be useful in post-accident situations; sweat patch testing may be useful in follow-up drug testing and treatment programs; POCTs and IITFs may be most useful for quickly identifying specimens that are negative for drugs and indicate that the specimen is valid.     

Regulation for the enforcement of federal health care provider conscience protection laws. Final rule

The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Section 245 of the Public Health Service Act, and the Weldon Amendment. These federal statutory health care provider conscience protections remain in effect.     

Cutoff Scores for the Morel Emotional Numbing Test for PTSD: Considerations for Use in VA Mental Health Examinations

The use of cutoff scores on symptom validity measures has been applied to determine the authenticity of posttraumatic stress disorder (PTSD) in U.S. Department of Veterans Affairs compensation and pension examinations. This approach is controversial due to variations in the interpretation and application of cutoff scores from symptom validity testing. In response to the proposal that the cutoff score on the Morel Emotional Numbing Test for Posttraumatic Stress Disorder (MENT) be increased, the diagnostic accuracy of the standard cutting score for identifying simulated symptoms of PTSD was compared to the proposed alternate cutoff score. The results of decision matrix tables (true positive, true negative, false positive, and false negative) comparing the sensitivity and specificity and deriving confidence intervals for the standard cutoff score and proposed alternate cutoff score are presented. In addition, analyses using binomial probability theory to determine whether the outcome of increasing the cutoff score on the MENT meets reasonable standards for types I and II errors are presented.     

An Investigation of Normal Urine with a Creatinine Concentration Under the Cutoff of 20 mg/dL for Specimen Validity Testing in a Toxicology Laboratory,

In clinical and forensic toxicology laboratories, one commonly used method for urine specimen validity testing is creatinine concentration. In this study, workplace guidelines are examined to determine their relevance to forensic and clinical toxicology samples. Specifically, it investigates the occurrence of urine creatinine concentrations under 20 mg/dL and notes potential issues with factors influencing creatinine concentration by utilizing a simple, novel method consisting of cation‐paring high‐pressure liquid chromatography in tandem with ultraviolet detection to determine the creatinine concentration in 3019 donors. Of the 4227 sample population in this study, 209 (4.94%) were below the cutoff value of 20 mg/dL for dilute urine. Because there are many factors that can influence the urinary creatinine concentration, samples that have creatinine under the 20 mg/dL cutoff do not always implicate sample adulteration.     

Oral fluid collection: the neglected variable in oral fluid testing

The potential to use oral fluid as a drug-testing specimen has been the subject of considerable scientific interest. The ease with which specimens can be collected and the potential for oral fluid (OF) drug concentrations to reflect blood-drug concentrations make it a potentially valuable specimen in clinical as well as forensic settings. However, the possible effects of the OF collection process on drug detection and quantification has often been over looked. Several studies have documented that drug-contamination of the oral cavity may skew oral fluid/blood drug ratios and confound interpretation when drugs are smoked, insufflated or ingested orally. OF pH is predicted to have an effect on the concentration of drugs in OF. However, in a controlled clinical study, the effect of pH was less than that of collection technique. Mean codeine OF concentrations in specimens collected a non-stimulating control method were 3.6 times higher than those in OF collected after acidic stimulation. Mean codeine concentrations were 50% lower than control using mechanical stimulation and 77% of control using commercial collection devices. Several factors should be considered if a commercial OF collection device is used. In vitro collection experiments demonstrated that the mean collection volume varied between devices from 0.82 to 1.86 mL. The percentage of the collected volume that could be recovered from the device varied from 18% to 83%. In vitro experiments demonstrated considerable variation in the recovery of amphetamines (16-59%), opiates (33-50%), cocaine and benzoylecgonine (61-97%), carboxy-THC (0-53%) and PCP (9-56%). Less variation in collection volume, volume recovered and drug recovery was observed intra-device. The THC stability was evaluated in a common commercial collection protocol. Samples in the collection buffer were relatively stable for 6 weeks when stored frozen. However, stability was marginal under refrigerated conditions and poor at room temperature. Very little has been published on the efficacy of using IgG concentration, or any other endogenous marker, as a measure of OF specimen validity. Preliminary rinsing experiments with moderate (50 mL and 2 x 50 mL) volumes of water did not reduce the OF IgG concentration below proposed specimen validity criteria. In summary, obvious and more subtle variables in the OF collection may have pronounced effects on OF-drug concentrations. This has rarely been acknowledged in the literature, but should to be considered in OF drug testing, interpretation of OF-drug results and future research studies.     

Finnish guidelines for workplace drug testing

The Finnish guidelines for workplace drug testing outlined here represent what is considered the best practice for workplace drug testing to be followed in Finland. The guidelines are based on the act on the protection of privacy in working life (759/2004), the occupational health care act (1383/2001) and the decree on workplace drug testing (218/2005). They start by defining situations in which workplace testing is allowed and continue up to the point where the certificate is submitted to the employer. The role of the occupational health care system is crucial in the procedure. The guidelines include the best practice procedures to be followed by laboratories providing workplace drug testing services. The laboratory recommendations are based on general principles established internationally. In the Finnish guidelines, accreditation is an absolute prerequisite for a laboratory functioning as a workplace drug testing laboratory. The laboratory section of the guidelines includes specimen collection, laboratory organisation, analysis procedure, quality assurance and quality control measures. These largely conform to the European laboratory guidelines for legally defensible workplace drug testing published by the European workplace drug testing society (EWDTS), but there are differences. In addition to using urine as a specimen, the Finnish guidelines also encompass blood.     

Oral fluid collection: The neglected variable in oral fluid testing

The potential to use oral fluid as a drug-testing specimen has been the subject of considerable scientific interest. The ease with which specimens can be collected and the potential for oral fluid (OF) drug concentrations to reflect blood–drug concentrations make it a potentially valuable specimen in clinical as well as forensic settings. However, the possible effects of the OF collection process on drug detection and quantification has often been over looked. Several studies have documented that drug-contamination of the oral cavity may skew oral fluid/blood drug ratios and confound interpretation when drugs are smoked, insufflated or ingested orally. OF pH is predicted to have an effect on the concentration of drugs in OF. However, in a controlled clinical study, the effect of pH was less than that of collection technique. Mean codeine OF concentrations in specimens collected a non-stimulating control method were 3.6 times higher than those in OF collected after acidic stimulation. Mean codeine concentrations were 50% lower than control using mechanical stimulation and 77% of control using commercial collection devices.Several factors should be considered if a commercial OF collection device is used. In vitro collection experiments demonstrated that the mean collection volume varied between devices from 0.82 to 1.86 mL. The percentage of the collected volume that could be recovered from the device varied from 18% to 83%. In vitro experiments demonstrated considerable variation in the recovery of amphetamines (16–59%), opiates (33–50%), cocaine and benzoylecgonine (61–97%), carboxy-THC (0–53%) and PCP (9–56%). Less variation in collection volume, volume recovered and drug recovery was observed intra-device. The THC stability was evaluated in a common commercial collection protocol. Samples in the collection buffer were relatively stable for 6 weeks when stored frozen. However, stability was marginal under refrigerated conditions and poor at room temperature. Very little has been published on the efficacy of using IgG concentration, or any other endogenous marker, as a measure of OF specimen validity. Preliminary rinsing experiments with moderate (50 mL and 2 × 50 mL) volumes of water did not reduce the OF IgG concentration below proposed specimen validity criteria. In summary, obvious and more subtle variables in the OF collection may have pronounced effects on OF–drug concentrations. This has rarely been acknowledged in the literature, but should to be considered in OF drug testing, interpretation of OF–drug results and future research studies.     

Making Sure Neuropsychological Data Are Meaningful: Use of Performance Validity Testing in Medicolegal and Clinical Contexts

Performance validity testing (PVT) is a standard of practice in situations where there are prominent secondary gain issues; however, it is suggested that their use may benefit neuropsychological evaluations in clinical contexts, as engagement in neuropsychological evaluations can affect the validity of testing and can occur for a variety of reasons outside of secondary gain issues. Several methods of embedded index development, as well as methods to combine them are discussed, including issues related to use of multiple indices. The potential limitations to administration of multiple indices are also explored. It is suggested that neuropsychological evaluations can benefit from PVT in regular clinical practice to assist with reaching firmer diagnostic conclusions by assuring test result validity.     

Procedures for transportation workplace drug and alcohol testing programs. Office of the Secretary, DOT. Final rule

The Department of Transportation is revising its drug and alcohol testing procedures regulation. The purposes of the revision are to make the organization and language of the regulation clearer, to incorporate guidance and interpretations of the rule into its text, and to update the rule to include new provisions responding to changes in technology, the testing industry, and the Department's program.     

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to reclassify over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls), and to exempt them from the premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also proposing to designate OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act), and to establish restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is proposing a conforming amendment to the existing classification regulation for specimen transport and storage containers, to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.     

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.     

Legal issues in oral fluid testing

The use of oral fluid for drugs of abuse testing has received increased attention with the availability of accurate methods for the collection and analysis of drugs in oral fluid specimens. Already used in the transportation and insurance industries, there is increasing interest in oral fluid drug testing in the workplace, schools, roadside driving under the influence of drugs, and criminal justice. Given that sanctions may accrue from positive test results, legal challenges are to be expected. However, with its established scientific base, demonstrated accuracy and reliability of collection and test methods, and current positive regulatory developments, it seems clear that the use of oral fluid as a specimen for drugs of abuse testing will be able to withstand judicial scrutiny.     

Legal issues in oral fluid testing

The use of oral fluid for drugs of abuse testing has received increased attention with the availability of accurate methods for the collection and analysis of drugs in oral fluid specimens. Already used in the transportation and insurance industries, there is increasing interest in oral fluid drug testing in the workplace, schools, roadside driving under the influence of drugs, and criminal justice. Given that sanctions may accrue from positive test results, legal challenges are to be expected. However, with its established scientific base, demonstrated accuracy and reliability of collection and test methods, and current positive regulatory developments, it seems clear that the use of oral fluid as a specimen for drugs of abuse testing will be able to withstand judicial scrutiny.     

Simultaneous detection of multiple STR loci on sex chromosomes for forensic testing of sex and identity.

The forensic usefulness of X and Y chromosomal STR loci has recently been demonstrated. One quadruplex-PCR, using 2 X- and 2 Y-STRs (STRX1/HPRTB and DYS390/ DYS393), and 2 duplex-PCRs, each using an X- and a Y-STR (ARA/DYS390 and ARA/DYS393), and detection of PCR products by using an automated DNA sequencer are reported herein. This approach allows us to determine not only the sex of the donor of a sample, but also the X- and/or Y-STR genotypes of the sample. A male biological specimen yields 4 amplified products in quadruplex-PCR and 2 amplified fragments in duplex-PCRs, whereas a female biological specimen yields only 2 amplified fragments of X-STR in quadruplex-PCR and one fragment, also of X-STR, in duplex-PCRs. Our study thus provides useful information for many activities in forensic practice, such as identity testing, paternity testing, especially of deficiency cases, compilation of population data, and sex determination of a biological sample from a single PCR.     

Partner Violence Entrapment Scale: Development and Psychometric Testing

This article describes the development and testing of the psychometric properties of the Partner Violence Entrapment Scale (PVES), an instrument that evaluates the women’s perceived reasons for staying in violent partner relationships. After initial pilot testing, the scale was administered to 213 Spanish women who were victims of intimate partner violence (IPV). An exploratory factor analysis identified six factors: Socio-Economic Problems, Attachment and Fear of Loneliness, Blaming Oneself and Resignation, Impact on Children, Fear of Harm and Worry for the Partner, and Feelings of Confusion. Discriminant validity was established by demonstrating associations between PVES factors and socio-demographic, clinical and abuse variables. The scale appears to be a useful assessment tool for social and clinical settings. Its factor structure, reliability, and validity need to be replicated in other populations and samples.     

Smallpox vaccine injury compensation program: Smallpox (Vaccinia) Vaccine Injury Table. Adoption of interim final rule as final rule with an amendment

This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.     

THE DETERMINATION OF ANTITRUST LIABILITY IN UNITED STATES v. MICROSOFT: THE EMPIRICAL EVIDENCE THE DEPARTMENT OF JUSTICE USED TO PROVE ITS CASE

This paper considers the empirical evidence used by the Departmentof Justice in the U.S. v. Microsoft antitrust case to provethat Microsoft engaged in exclusionary (and anticompetitive)actions in the browser market as part of its efforts to maintainits dominance of the personal computer operating system market.This evidence deserves special consideration because the DistrictCourt made the unusual decision to rely on the empirical evidencepresented by the Department of Justice rather than the empiricalevidence presented by Microsoft. This decision was unusual becauseMicrosoft's evidence had a strong presumption of validity asit was based on data that Microsoft collected and used in theordinary course of its business. Furthermore, no market participantsused the Department of Justice-sponsored data in any meaningfulway. Although it is impossible to determine with any certaintywhy the District Court ruled the way it did, I conclude thatthere were two driving forces in the court's decision. The Departmentof Justice identified serious flaws in Microsoft's data, makingit unreliable for the purposes for which Microsoft was usingit in the trial. The Department of Justice was also able toshow that no such flaws affected the data it sponsored and indeed,on many points, that data was more consistent with the testimonyof Microsoft executives than the data sponsored by Microsoft.     

Prediction of police officer performance with the inwald personality inventory

The Inwald Personality Inventory (IPI) was administered to police officer applicants during pre-employment psychological screening. Scores were used to predict applicant performance, as rated by supervisors, after one year of active duty and change in performance over a 10-month period. Performance was significantly predicted by IPI scales, including Family Conflicts, Guardedness, and Driving Violations. These findings support the predictive validity of the IPI and identify specific characteristics of applicants that may influence performance in the field. Author's Note: Paul Detrick, PhD, Florissant Psychological Services; John T. Chibnall, PhD, Department of Psychiatry, Saint Louis University School of Medicine. The authors thank Sarah Crank, Mariann Luther, and Dinah Michael for their helpful assistance with this project. Special thanks to Captain John Roach of the St. Louis Conty Police Department for his valuable support and contributions. Correspondence concerning this article should be addressed to Paul Detrick Florissant Psychological Services     

The medical review officer: a potential role for the medical examiner

Drug use in the workplace is a problem, both in terms of public health and expense. Workplace drug testing programs serve as deterrents to drug use. Model programs, such as that of the Department of Transportation, use urine screening and are federally regulated or follow federal standards. An essential participant in this process is the medical review officer (MRO), a licensed physician who interprets the laboratory results generated from a workplace drug testing program. As a result of their training and experience with toxicology, collection of evidence, testimony, and recognition of the physical signs of drug abuse, medical examiners and forensic pathologists are well suited to serve as MROs. Recent regulations require the completion of training courses and MRO certification as prerequisites for participation in federal drug testing programs. Several courses are available to train physicians to participate as MROs.