Drug & Alcohol Newsletter Issue 25

U.S. Department of Transportation
Federal Transit Administration
Office of Safety and Security

FTA Drug And Alcohol Regulation Updates

Summer 2003 Issue 25

Introduction....

The Federal Transit Administration (FTA) published its revised rule on prohibited drug use and the prevention of alcohol misuse (49 CFR Part 655) on August 1, 2001. The FTA published the revised Implementation Guidelines for Drug and Alcohol Regulations in Mass Transit to provide a comprehensive overview of the regulations.

Since the Guidelines were published, there have been numerous amendments, interpretations, and clarifications to the Drug and Alcohol testing procedures and program requirements.

This publication is being provided to update the Guidelines and inform your transit system of these changes. This Update is the twenty-fifth in a series.

Inside....

Regulatory Update 2

Clarifications and Corrections 3

For Your Information 4

Rx & OTC Medications 5

Resources & Materials 6

HIPAA and DOT Rules Don't Conflict

The Department of Health and Human Services (HHS) promulgated a rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) that established national standards for safeguards to protect the integrity, confidentiality, and availability of electronic health information. The rule covers the risk of improper access to stored information and the risk of interception during electronic transmission of information.

The HHS HIPAA rule requires the consent or authorization from an individual any time information is released regarding a person’s “preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care or the past, present, or future physical or mental health or condition of an individual.” Information obtained as part of a Department of Transportation (DOT) drug and alcohol testing program is not considered “health information” covered by HIPAA rules and therefore, does not require employers and service agents in the DOT drug and alcohol testing program to obtain written employee authorization to disclose drug and alcohol testing information required by DOT and FTA rules (49 CFR Parts 40 and 655, respectively). The DOT/FTA testing program only considers the employee’s compliance with safety regulations and does not address any employee health considerations.

In addition, Part 164.512 of the HHS rule further explains that employee authorization is not necessary where Federal law requires the use or disclosure of otherwise protected health information. Parts 40 and 655 clearly stipulate the specific circumstances that require employee authorization or consent. Required disclosure or use of other information cited by the rules does not necessitate employee authorization or consent.

Consequently, employers do not need employee authorizations to conduct DOT tests. Employers need to notify applicants of the need for a pre-employment test and employees need to be provided with a policy statement that indicates participation in the testing program is a condition of employment, but no employee authorization is required.

Collectors do not need authorizations to perform DOT urine collections, to distribute Custody and Control Forms, or to send specimens to laboratories. Screen Test Technicians (STT) and Breath Alcohol Technicians (BAT) do not need authorizations to perform DOT alcohol tests or to report test results to employers. Laboratories do not need employee authorization to perform DOT drug and validity tests, or to report results to designated Medical Review Officers (MROs).

Likewise, MROs do not need employee authorization to verify drug test results, to discuss alternative medical explanations with prescribing physicians and issuing pharmacists, to report results to employers, to confer with Substance Abuse Professionals (SAPs) and evaluating physicians, or to report other medical information. Evaluating physicians are also allowed to report evaluation information and results to MROs or to employers, as appropriate without employee consent.

SAPs do not need employee authorization to conduct SAP evaluations, to confer with employers, to confer with MROs, to confer with appropriate education and treatment providers, or to provide SAP reports to employers. Consortia/Third Party Administrators are also allowed to bill employers for service agent functions they perform or contract out without employee consent.

Not only does the HHS rule (45CFR Part 164.512) enable employers and service agents in the DOT program to disclose information without the employee’s authorization, but additionally, 49 CFR Part 40.355 clearly prohibits any service agent to require individuals to sign consents, releases, waivers, indemnifications, or any other form that is not part of the DOT procedures as defined in Part 40. In conclusion, HHS and DOT both agree that there is no conflict between the HIPAA and DOT rules.

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FTA Drug and Alcohol Regulation Updates Issue 25, page 2

REGULATORY UPDATE

Where To Find?.....

49 CFR Part 655, Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations

August 9, 2001 Federal Register Vol. 66 Pages 41996 - 42036

Notice of Interpretation: April 22, 2002 Federal Register Vol. 67, Pages 19615-19616 Primary Topic: FTA/USCG regulation applicability to ferry boats.

The information presented on this page should be used to update Chapter 7 of the revised Implementation Guidelines. After a long and controversial scientific debate, the Department of Health and Human Services (HHS) withdrew its proposed specimen validity testing (SVT) guidelines. In the absence of this guidance and in light of new scientific information, the Department of Transportation (DOT) published an interim final rule (IFR) to establish new dilute and substitute specimen criteria to be used for DOT mandated drug testing. The interim final rule that amended 49 CFR Part 40 was published in the Federal Register (Vol. 68, No. 102, pp 31624-31627) on May 28, 2003. The need for the change became evident at a recent conference where technical experts disagreed on the minimum creatinine standard that should be used to determine if a specimen is substitute. Previously, the standard used in the DOT drug testing procedures (49 CFR Part 40.93(b)) was a creatinine concentration of less than or equal to 5 mg/dL and a specific gravity of less than or equal to 1.001 or greater than or equal to 1.020. This standard was based on studies by the HHS and constituted the best scientific information available at the time the DOT rule was published on August 1, 2001. Since that time, additional information has become available that puts this standard into question including a small number of cases in which individuals may have legitimate medical or physiological explanations for producing specimens with lower levels of creatinine.

This criterion is important because it is the measure used to determine if an employee’s specimen is substitute, and therefore, whether it constitutes a test refusal with resulting consequences. The intent was to establish the standard at a level that would eliminate the possibility that an individual could naturally produce such a specimen and thus, would provide evidence of substitution. Recent evidence indicates, however, there is a relatively small number of individuals who are capable of producing creatinine concentrations below the previous standard.

Experts agree that the standard should be lowered. The level should be low enough to ensure that individuals are not unfairly charged with substitution, however, the level must be high enough to identify individuals that substitute specimens to evade detection of drug use. While awaiting HHS guidance, the DOT decided to publish the interim final rule setting forth the following four basic provisions.

Laboratories are directed to report to MROs the creatinine and specific gravity quantifications for all DOT specimens that meet the regulatory substitution criteria (§40.93). Laboratories must provide quantitative values only when the concentration is above their minimum detection limit. Any reading below the minimum limit must be reported as “creatinine not detected.” If a creatinine level of a specimen is less than 2mg/dL or “creatinine not detected,” the MRO must report the specimen as “substituted.” If a creatinine level of a specimen is greater than or equal to 2mg/dL, but less than 20mg/dL, the MRO must report the specimen as “dilute” and negative or positive. If a specimen has a creatinine level greater than or equal to 2mg/dL but less than or equal to 5 mg/dL, the MRO must also direct the employer to require the employee to undergo an unannounced immediate recollection under direct observation and the employer must make sure the recollection takes place. The rule did not change regarding specimens with creatinine levels above 5 mg/dL, but less than 20 mg/dL. In these cases, the employer determines whether to require a retest as a matter of policy. If negative dilute retests are required under this threshold, they may not be performed under direct observation (§40.197).

Laboratories are not currently required to conduct validity testing as part of the DOT testing program, but those that do, must follow the current standard. As with the previous rule, any individual that provides a specimen below the current standard (i.e., less than 2 mg/dL) has the ability to challenge the substitute determination by demonstrating that there is a legitimate medical explanation for the result following the procedures outlined in §40.145.

The DOT is requesting public comments on the IFR by August 26, 2003. Comments should refer to Docket Number OST-2003-15245 and should be sent to the Docket Management System, USDOT, Room PL-401, 400 Seventh Street, S.W., Washington, D.C. 20590-0001 or electronically to http://dms.dot.gov/.

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SERVICE AGENT UPDATE

FTA Drug and Alcohol Regulation Updates Issue 24, page 3

Agencies Offer SAP Exams

The FTA regulations require that all individuals who have a positive drug or alcohol test or who refuse a test must be referred to a Substance Abuse Professional (SAP) regardless of whether the employer’s policy is to terminate the employee or provide a second chance. If an employer allows an employee to return to duty following a positive test result or test refusal, the individual cannot be allowed to return to a safety-sensitive position until he/ she has completed the SAP evaluation, referral, education/treatment, and return-to-duty process. The SAP is the "gatekeeper" of the return-to-duty process and is responsible for protecting public safety to the greatest extent possible by professionally evaluating the employee and recommending appropriate education/treatment, follow-up tests, and after-care in the event the employee returns to performing safety-sensitive functions. Subpart O of Part 40 defines the SAP qualifications, roles, responsibilities and procedures. To be recognized as a SAP an individual must be a licensed physician; a licensed or certified psychologist; a licensed or certified social worker a licensed or certified employee assistance professional; or an alcohol or drug abuse counselor certified by the National Association of Alcoholism and Drug Abuse Counselors (NAADAC), or by the International Certification Reciprocity Consortium/Alcohol and Other Drug Abuse (ICRC). The SAP must have knowledge of and clinical experience in the diagnosis and treatment of substance abuse-related disorders, and must have knowledge of the SAP’s role in the protection of public safety. The SAP must complete qualifications training by De-cember 31, 2003 and satisfactorily complete an examination that is given by a nationally recognized professional or training organization. The examination must cover all elements discussed in the qualifications training, and the test must be validated by a test evaluation organization. A number of agencies are offering the qualifications training, but only two are currently offering the examination. The National Association of Alcoholism and Drug Abuse Counselors (NAADAC) offers a manual and a test that can be ordered by contacting the NAADAC Education and Certification Administrator at sbeckett@naadac.org. The Employee Assistance Professionals Association (EAPA) offers qualifications training and an on-line exam. For more information contact a.osullivan@eap-association.org.

All Collectors Must Be Trained

The deadline for collectors to receive qualifications training passed on January 31, 2003. Consequently, all existing collectors conducting collections under the USDOT rule (49 CFR Part 40) must have completed the training and demonstrated proficiency to be in compliance. All future collectors must receive the training and demonstrate proficiency before they perform any collections. This means all collectors including those that work at hospitals, clinics, and emergency care units and those that perform these duties infrequently or on an incidental basis must comply. There are no exceptions. The number, frequency, or clinical environment of the test is irrelevant. All collectors must meet the minimum requirements.

Where To Find?.....

49 CFR Part 40, Procedures for Transportation Workplace Drug Testing Programs

Revised: December 19, 2000 Federal Register Vol. 65, Pages 79462-79579. Primary Topic: Procedures for Transportation Workplace Drug and Alcohol Testing Program Revised Final Rule (49 CFR Part 40)

Technical Amendments: August 1, 2001 Federal Register Vol. 66 Pages 41943-41955 Primary Topic: Clarifications and Collections to Part 40; Common Preamble to Modal Rules

Notice of Proposed Rulemaking: September 30, 2002 Federal Register Vol. 67 Pages 61306-61313 Primary Topic: MIS Reporting

HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs Notice of Proposed Rulemaking:

August 21, 2001 Federal Register Vol. 66 Pages 43876-43882 Primary Topic: Validity Testing

The information presented on this page should be used to update Chapter 5 of the revised Implementation Guidelines.

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FTA Drug and Alcohol Regulation Updates Issue 25, page 4

FOR YOUR INFORMATION

Where to Find? ..... DHHS Labs

The current list of DHHS certified labs is published the first week of each month and is printed in the Federal Register under the Substance Abuse and Mental Health Services Administration (SAMHSA) heading. Only those labs certified can be used for FTA drug testing. The list should be checked monthly as new labs are being added and others are being removed.

Website location: http:// www.workplace.samhsa.gov/ ResourceCenter/lablist.htm

To verify the certification status of a laboratory, DHHS has established a telephone HELPLINE (800) 843-4971.

The information presented on this page should be used to update Chapter 12 of the revised Implementation Guidelines. Effective Oversight Need Not Be Costly All FTA grantees and subrecipients are responsible for the full compliance of their system with the FTA drug and alcohol testing regulations including their contractors that perform safety-sensitive job functions. The only safety-sensitive contractors that are exempt from the rules are maintenance contractors that provide services for urban Section 5309 and 5307 funded systems that serve populations of 200,000 or less and Section 5311 rural systems. All other safety-sensitive contractors must meet the same standards for compliance as the grantee/subrecipient.

Consequently, grantees/subrecipients must oversee their contractors to ensure compliance. The regulation does not specify the nature or extent of oversight efforts. The regulation gives wide latitude to grantees/subrecipients to take whatever actions they deem necessary to ensure their contractors’ compliance. There is a wide array of oversight methodologies in practice within the industry reflecting the financial, political, and operational environment of each unique grantee. Some systems provide technical assistance, policy review and training, others conduct desk reviews using compliance checklists, while still others conduct periodic mock audits. All of these methods and many others are acceptable and represent a wide range of associated administrative burden and cost.

A common misconception among grantees/subrecipients is that the oversight requirements can only be met by conducting periodic, labor intensive, and costly mock audits. Some agencies have felt compelled to hire additional staff to address the resultant workload. This level of oversight is not a requirement of the regulation. Even though an aggressive program of mock audits and intensive oversight is commendable and offers a high level of compliance assurance, other less costly methods may be as effective.

The Best Practices Manual: FTA Drug and Alcohol Testing Program discusses contractor oversight and provides examples of contractor oversight checklists (Section 4.2 and Appendix C). These checklists can be used to document oversight efforts and identify areas that require corrective action.

The most successful oversight programs are ones based on a positive relationship between grantee and contractor where the two parties work together to ensure compliance. Often grantees offer resource materials, employee, supervisor and management training, and technical assistance to their contractors. Contractors can be included in the grantee’s random pool and piggyback onto the grantee’s contracts with service agents. It is also common for grantees to assist contractors in establishing record keeping procedures and preparation of MIS reports. Each of these low cost/no cost efforts are acceptable oversight techniques and improve the grantee’s level of assurance that contractors are in compliance.

Oversight programs that successfully identify problem areas and initiate corrective actions will enhance the integrity of each contractor’s testing program, minimize compliance issues, avoid potential legal conflicts, and improve the overall effectiveness of the program.

Workplace Drug Use Lowest in 14 Years

Quest Diagnostics Incorporated (QDI) recently released its annual Drug Testing Indexâ (DTI) for 2002. The DTI summarized the results of workplace drug tests performed during the year by QDI, the leading provider of employer drug testing services in the United States. Overall, workplace drug use and specifically, federally mandated safety-sensitive employee drug use continued its steady decline resulting in a fourteen year low in 2002. In 2002, the positive rate for federally mandated drug tests for all testing categories was 2.5 percent. The decline was across all test types and drug categories. A similar decline was experienced in the positive rate for all workplace testing dropping from a 1988 high of 13.6 percent to a 2002 low of 4.4 percent. The general workforce, experienced a seventy percent rise in amphetamine use since 1998 reflecting an increase in production and trafficking, while the federally-mandated workforce amphetamine use remained stable.

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Rx & OTC Medications

FTA Drug and Alcohol Regulation Updates Issue 24, page 5

Employer Rx/OTC Policy Guidance

All FTA employers are strongly encouraged to develop a policy statement addressing the use of prescription (Rx) and over-the-counter (OTC) medications. Even though the policy is not an FTA requirement, a policy statement is an essential part of a comprehensive program designed to educate transit employees on the potential safety risks associated with the use of Rx and OTC medications by employees who perform safety-sensitive duties. An effective Rx/OTC policy statement will include the following provisions:

Emphasis on safety--statement of risks associated with Rx/OTC use. Statement of purpose: to balance the treatment of medical conditions with requirements of performing safety-sensitive job duties. Not intended to force employees in need of medical attention to work. Not intended to keep employees receiving medical treatment off duty who are able to work. Requirements for obtaining medical input into an employee’s fitness-for-duty. The policy should address the use of Rx/OTC in relation to the underlying medical condition or illness in determining an employee’s ability to safely perform safety-sensitive duties. Statement regarding the removal of employees from safety-sensitive duty who are impaired by Rx/OTC medications. Describe responsibility for employee initiated removal and management initiated removal. An attendance policy that reflects Rx/OTC-use related absences. Be careful that your attendance policy does not inadvertently encourage employees from reporting for work or remaining on duty when impaired by illness or Rx/OTC use (i.e., no sick leave; Rx/OTC use ineligible for leave, etc.). Be sure to consider Rx/OTC use when establishing limitations on sick leave use. Limitations on use of certain types of medication. Employers may choose to prohibit certain types of medications or medications with specific types of warnings or side effects. At a minimum, medications that cause drowsiness, fatigue or have warning labels that caution against the operation of machines, heavy equipment, or automobiles should be prohibited. Requirements for obtaining medical authorization to use certain medications. Employer responsibility for final determination. Definition of employees’ responsibilities. Employee reporting requirements. Consequences for policy violations including the use of Rx/OTC that contributes to cause or severity of an accident and failure to report use or obtain medical authorization, if required. Statement of confidentiality in relation to records and interaction with medical practitioners. Employers should refrain from policies that are based solely on the employee’s perception of impairment. Employees are commonly unaware or unable to accurately ascertain their degree of impairment and may report for work or remain on duty when they pose a safety risk to themselves, other transit system employees and the general public. Thus, employers are discouraged from developing policies that rely solely on employee self-assessment and instead, are encouraged to develop policies that require a medical evaluation and input into an individual’s overall fitness for duty. Where to Find? .....

Conforming Products List Evidential Breath Testing (EBT) Devices July 21, 2000 Federal Register Vol.65 Pages 45419 - 45423 Primary Topic: Conforming Products List (CPL) Website location: www.nhtsa.gov/people/injury/ alcohol

Note: This list will be updated periodically.

Non-evidential Testing Devices May 4, 2001 Federal Register Vol.66 Pages 22639 - 22640 Primary Topic: Initial Alcohol Screening Devices

Note: This list will be updated periodically.

The information presented on this page should be used to update Chapter 5 of the revised Implementation Guidelines.

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FTA Drug and Alcohol Regulation Updates Issue 25, page 6

Resource Materials

Who Should Be Receiving This Update?

In an attempt to keep each transit system well informed, we need to reach the correct person within each organization. If you are not responsible for your system's Drug and Alcohol program, please forward this update to the person(s) who is and notify us of the correct listing. If you know of others who would benefit from this publication, please contact us at the following address to include them on the mailing list. This publication is free.

RLS & Associates, Inc. 3131 South Dixie Hwy. Suite 545 Dayton, Ohio 45439 Phone: (937) 299-5007 FAX: (937) 299-1055 rlsasc@mindspring.com

FTA home page: www.fta.dot.gov FTA Office of Chief Counsel: http://www.fta.dot.gov/office/chiefc FTA Office of Safety & Security: http://transit-safety.volpe.dot.gov FTA Letters of Interpretation: http://www.fta.dot.gov/library/legal/dral/02toc.htm DHHS-Certified Laboratories: http://www.workplace.samhsa.gov/ResourceCenter/lablist.htm Center for Substance Abuse Prevention: http://prevention.samhsa.gov FTA, Office of Safety and Security: (202) 366-2896 Best Practices Manual: FTA Drug & Alcohol Testing Program Drug and Alcohol Consortia Manual Drug and Alcohol Testing Results: 1995, 1996, 1997, 1998, 1999 and 2000 Annual Reports Random Drug Testing Manual Implementation Guidelines for Drug and Alcohol Regulations in Mass Transit, Revised 2002 Reasonable Suspicion Referral for Drug and Alcohol Testing (Leaders’ Guide & Video) FTA Drug and Alcohol Program Assessment Prescription and Over-The-Counter Medications Toolkit USDOT Drug and Alcohol Documents FAX on Demand: 1 (800) 225-3784 USDOT, Office of Drug and Alcohol Policy and Compliance: (202) 366-3784 Urine Specimen Collection Procedures Guideline Substance Abuse Professional Guidelines Produced by:

FTA - Office of Safety and Security 400 7th Street SW Washington, DC 20590

Published by:

USDOT-John A. Volpe National Transportation Systems Center Kendall Square Cambridge, MA 02142

Edited by: RLS & Associates, Inc. 3131 South Dixie Highway Suite 545 Dayton, OH 45439

Illustrated by: Dan Muko

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