Transcript CONFIDENTIALITY & RELEASE OF INFORMATION

DOT Regulations
Teleconference
An Overview for Employers
July 10 - 12, 2001
Department of Transportation
Department of Transportation
202-366-3784
www.dot.gov/ost/dapc
United States
Coast Guard
(USCG)
202.267.0684
Research and
Special Programs
(RSPA)
202.366.6199
Federal Motor Carriers
Safety Administration
(FHWA)
202.366.4016
Federal Transit
Administration
(FTA)
202.366.1080
Federal Railroad
Administration
(FRA)
202.493.6313
Federal Aviation
Administration
(FAA)
202.267.8442
DOT and HHS
HHS
Department of Health and
Human Services
DOT
Department of
Transportation
SAMHSA
Substance Abuse and Mental
Health Safety Administration
Operating Agencies
FMCSA, FAA,RSPA
USCG, FTA, FMCSA
Drugs
Levels
Types of testing
Hair
Urine
Saliva
Breath
Sweat
Blood
Validity
Regulations
and Requirements
Implementation Dates
•
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
Employer Responsibility
Subpart B, Part 40.11
• 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
Rule
• 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
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
Collector Training
Error Correction Training
• 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)
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 2nd 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, e-mail [email protected]
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: 301-841-0463
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 recollection 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 recollection 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.
Requests for
Split Specimen Test II
• 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.
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 2nd 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:
[email protected]