DOT Regulations Teleconference An Overview for Employers July , 2001

Department of Transportation

DOT and HHS

January 18, 2001 – Amendments to current rule: –Validity testing guidelines –Adulterated/Substituted MRO Review & Split Testing –Public Interest Exclusion (PIE) August 1, 2001 – Implementation of the full new rule Implementation Dates

Employer Responsibility Subpart B, Part Employers are now responsible for compliance with the Part 40 requirements. DOT and Non-DOT programs must be conducted completely separately Action required of employers upon receipt of verified test results are now detailed in the rules.

Stand Down Definition To remove a donor who has a positive laboratory result from duty until the Medical Review Officer completes the review.

Stand-down is prohibited! MRO cannot tell employer about laboratory result until after verification is completed. Rationale: Prevent unfair labeling of employee as violator before MRO review is complete – key safeguard. Employers may apply for a waiver – difficult to get Stand Down Rule

New Terminology: SA SA = Service Agent is someone other than an employer or employee who provides Part 40 drug and alcohol services to an employer or an employee. EHP is a Service Agent

New Terminology:DER DER = Designated Employer Representative Replaces the term Communicator used by Service Agents.

PIE-NOPE Public Interest Exclusion (PIE) –Purpose is to protect public interest from serious noncompliance –Initiating official issues a Notice of Proposed Exclusion (NOPE) –Employers must stop using service agent within 90 days of PIE issuance –Duration 1-5 years

New Training Requirements New rule strengthens training requirements for MROs, SAPs, Collectors, BATs, and STTs Purpose: To reduce the potential for errors and to make the process work better for everyone.

Urine Collection Policy Change I Major change - Collector training –Collector training is now required –Re-training is required after fatal flaw or any error that causes a drug test to be cancelled –Collectors must maintain documentation of their training & provide it to DOT agency, employers, or any service agents who use the collectors’ services.

Collector Training Initial Proficiency Demonstration After Qualification Training: Demonstration by conducting 5 consecutive error-free mock collections Must include 2 uneventful; 1 insufficient quantity; 1 temperature out of range; and 1 refusal to sign or initial In front of a person who monitors and evaluates proficiency

Required when a Collector makes a mistake which causes a test to be cancelled Required within 30 days of error notification Provided and documented by trainer Must address area in which error occurred Three consecutive error-free mock collections (1 uneventful; 2 related to error area) Collector Training Error Correction Training

Urine Collection Policy Change II Donor must display contents of pocket Collector, not donor, transfers urine, closes and seals specimen bottle

Urine Collection Policy Change III If temperature is outside of normal range the collector can no longer take an oral temperature or sleeved thermometer temperature. An immediate directly observed specimen is required.

Mandatory Direct Observation Collector Initiated Done immediately when temperature out of range or any suspicion of tampering NO requirement to take body temperature NO requirement to seek concurrence from supervisor or employer, but must notify afterwards

Mandatory Direct Observation Employer: MUST require observed collection if lab reports invalid test and MRO states no medical reason; or if result is positive, adulterated or substituted and a requested split specimen is not available for analysis. Collector: MUST require observed collection if he/she observes action indicating attempt to tamper; if temperature out of range; or if specimen appears to have been tampered with.

Permissive Direct Observation Employer: Option to conduct direct observation for return-to-duty or follow-up test Encourage employers to write letters to DOT about the difficulty of this.

Monitored Collection Procedure I NOT a directly observed collection Done at employer’s discretion Primarily intended to be used where only a multi-stall restroom is available Monitors should be same gender unless they are medical professionals

Monitored Collection II Monitored collections are not substitutes for observed collections Sounds or observations indicating an attempt to tamper result in observed collection Monitor -- who is not collector -- does not handle urine specimen

New CCF Labs will begin printing and automatically shipping in July 5 page format –CCF 1 Lab Copy –CCF 2 MRO Copy –CCF 3 Collector Copy –CCF 4 Employer Copy –CCF 5 Donor Copy

The New CCF PRIOR TO to August 1, 2001, employers –May use new form –Must use current collection procedures AS OF August 1, 2001, employers –Must use new form –Must use new procedures May not use form for non-DOT tests

“ Shy Bladder” Procedure Urge employee to drink up to 40 oz. Refusal to drink is not refusal to test Refusal to make an attempt to provide – –Discontinue test –Contact DER 3-hour time limit Send CCF copies to MRO & employer Contact MRO and open a case at EHP for compliance with on-going Shy Bladder procedures

Dilute Specimen A negative dilute specimen does not trigger direct observation Employer may conduct a 2 nd collection – same policy for all employees but can vary by reason for test If second specimen comes back dilute, it must be accepted as a negative MUST be included in policy and applied equally throughout the company

Refusal to Test I An employee fails: –To appear or remain at site –To provide urine specimen when required –To permit directly observed or monitored coll. –To take a second test as directed –To provide sufficient urine (w/no med. explanation) –To undergo medical evaluation –To cooperate with testing process in any way

Refusal to Test II –Employer must establish allotted time for the person to show up at collection site after being sent, include it in company policy, and notify collectors –Collectors notify employer if donor does not arrive within allotted time –May be refusal to test

Drug Testing Laboratories All DOT specimens are inspected for “fatal flaws” and “correctable errors” All specimens are tested for 5 drugs (THC, COC, PCP, OPI,AMP) using HHS cutoffs for initial & confirmation tests All specimens may be subjected to validity testing (will be mandatory when HHS defines adulteration criteria, certifies labs)

“ Fatal Flaws” Lab inspects each specimen & CCF –Specimen & bottle IDs do not match –Bottle seal is broken or tampered with –Collector’s name and signature omitted –Insufficient urine If found – testing process stops No longer called “Lab Reject” Lab will report to MRO and MRO will report as “ Test Cancelled (reason)”

“Correctable Errors” I Lab inspects each specimen & CCF– –Specimen temperature not checked & no remark re. outside temperature range –Collector’s signature omitted If found – document error, testing continues, lab attempts to correct No longer called “Lab Reject” If not corrected, lab will report to MRO and MRO will report as “ Test cancelled (reason)”

“Correctable Errors” II MRO inspects CCF 2 –Donor signature omitted with no remarks about donor refusing to sign –Certifying scientist signature omitted –Non-DOT CCF If found, MRO attempts to correct. If unable to correct, will report as “Test cancelled (reason)”

Specimen Validity Testing Dilution & Substitution Voluntary but done by all major labs to some degree Each specimen must be measured for –Creatinine –Specific gravity if creatinine is less than 20 mg/dL –pH

Specimen Validity Testing Adulteration Each specimen may be tested for substances that may be used to adulterate the specimen HHS will define the test requirements Specimens suspected of containing an adulterant may be sent to another HHS laboratory for identification

Medical Review Officers (MRO) Credentials: MROs must be licensed MD or DO with clinical experience in substance abuse and must be certified by MROCC, AAMRO, or ASAM For a copy of EHP’s MRO credentials for your records,

MRO Responsibilities Review & Report - Negative Results Review lab report and CCF (w/ employee signature) Staff under supervision of MRO may perform this administrative function Prior to reporting, MRO must have -- –Copy 1 from lab or electronic lab report –MRO copy (Copy 2), legible copy, or any copy with employee signature

MRO Responsibilities Quality Control - Negative Results MROs must review 5% of negative CCFs per quarter, including all of those requiring corrective action. Reviewed CCFs must be identifiable and retrievable for audit. EHP is establishing a dedicated DOT fax line for results and CCFs:

MRO Responsibilities Contacting Donors - Non-Negative Results Before contacting the DER, the MRO must: –Have copy 1 from lab (faxed copy or image) –Have MRO copy (Copy 2), legible copy, or any copy with employee signature –Make three attempts to contact donor at varying times of day over at least 24 hour period Result will remain IN PROCESS until all of the above are complete.

MRO Responsibilities Review & Report - Non-Negative Results If contact CAN be made, interview the donor, verify and report the result If contact CANNOT be made, contact DER

DER Responsibilities Contacting Donors - Non-Negative Results Once contact to the DER is made, the DER takes responsibility for contacting the donor. DER must: –Try to contact the donor by all means available, including certified letters –If contact is made, direct donor to call the MRO and explain the consequences of failing to do so –Send MRO documentation of contact date and time

MRO Responsibilities Report “Non-Contact” Positive Results If CONTACT IS MADE and donor does not call, the MRO will report the result as positive in three (3) days If CONTACT IS NOT MADE, and if DER has exhausted all means of contacting the donor, the MRO will report as positive after ten (10) days without contact. 60 Day window for employee to present documentation for no contact

MRO Responsibilities: Adulterated/Substituted Employee has burden of proof –ADULTERATION: Must demonstrate adulterant entered specimen through physiologic means –SUBSTITUTION: Must demonstrate that he or she can produce urine meeting criteria through physiological means MRO may allow employee up to 5 days to provide proof MRO must explain split specimen option

MRO Responsibilities: Invalid Result Discuss with certifying scientist Contact employee for explanation If valid medical reason – cancel test (no re- collection unless negative needed) –MRO may involve a “referral physician”, acceptable to both MRO and employer, to help verify medical explanation If no valid medical reason – cancel test, immediate directly observed re-collection

MRO Responsibilities: Rejected for Testing Report to DER cancelled test and the reason. MRO will direct DER if further action or re- collection is required.

Requests for Split Specimen Test I On positive result or refusal to test (adulterated/substituted), MRO must explain split specimen testing process to employee Employee has 72 hours after verification to request test of split specimen.

Employer is required to make sure that MROs and laboratories process split specimen tests in a timely fashion when requested by donor MRO must process split specimen on verbal request from donor and payment must be guaranteed by the employer; however, employer may seek reimbursement from donor. Requests for Split Specimen Test II

Alcohol Testing Few procedural changes Results are reported directly to DER Training and certification of BATs parallels new training regulation of urine collections

Substance Abuse Professional: SAP Overview DOT employers are required to give all employees and applicants contact information for a SAP. Employer is not required to pay for SAP assessment. SAP must not make a fitness for duty determination; return to duty is an employer decision.

Records and Maintenance Service Agent –May receive and maintain – for the employer – all drug & alcohol records –Includes individual test results (negative, positive, and refusal to test) –Information needed to operate a program (e.g., CCFs, ATFs, names in random pools, selection lists, and testing notices) –Service Agent has two days to get the information to the employer. Charges may be applicable.

Record Retention Requirements Five years: –Alcohol test results of 0.02 or greater –Positive drug tests –Documentation of refusal to test (incl. adulterated and substituted test results) –SAP reports –Follow-up test results and schedules

Record Retention Requirements Three years: –Records obtained from previous employers Two years: –Records of inspection, maintenance, and calibration of EBTs One year: –Negative and cancelled drug tests, and alcohol tests less than 0.02

Confidentiality and Release of Information Employer or Service Agent prohibited from releasing to third parties not specifically authorized Specific written consent required; no blanket releases MRO must not disclose to 2 nd employer (NPRM proposal) May release in legal proceedings, criminal or civil actions

EMPLOYER RESPONSIBILITIES

General Responsibilities Responsible for all rule requirements Responsible for ensuring SA meets all qualifications For new employees, obtain previous 2 years of testing information* As previous employer, provide 2 years of testing information* *with employee written permission

Quality Control (Blind) Specimens 2,000 or more covered employees (applies to both employers & C/TPAs) 1% of specimens (maximum of 50 per quarter) Send to all labs used 75% negatives 15% positive for one or more drugs 10% adulterated and/or substituted

Testing Ensure split specimen requests are honored Ensure that observed collections take place as required Separate DOT and non-DOT testing Take no personnel action for cancelled tests

Return-to-duty (RTD) Process Provide listing of SAPs at no charge to employee No employer requirement to provide SAP evaluation or treatment No safety-sensitive duties until employee completes SAP requirements RTD test only after SAP’s follow-up report

Thank you For questions contact: