* not updated past the 2001 rules changes *

PART 40 CHANGES
As of 8/1/01, ALL of these changes are in effect!


SUMMARY OF NEW PROVISIONS, & REGULATIONS

© Copyright, 2001, Daniel C. Drew, M.D.  All rights reserved!
ADMINISTRATIVE REGULATIONS
[Sub Part A]
§ ENTIRE
   FINAL
   RULE		 FORMAT OF THE NEW REGULATIONS:
GOOD NEWS
  • FAQ format...  The prevailing format in the cyber world.
  • The regs have won an important "plain language" award!

    • BAD NEWS
  • Numbering system is completely new!
  • We must "unlearn" section numbers from older regs!
    		•

    § 40.1 APPLICABILITY: (To whom do these regulations apply)
  • The "players" are basically as in prior regs.
  • Service Providers (SA) is a new term for several "old players."
  • New regs specifically mention self employed contractors.
  • Volunteers are mentioned in new regs.
    		•
    § ENTIRE 
       FINAL 
       RULE    		 SUMMARY OF "THE PLAYERS"
  • Employee (donor)
  • Employer
  • DER (Designated Employer Rep)
  • Collector
  • Laboratory
  • MRO
  • BAT
  • C/TPA
  • SAP
  • Referral Physicians  (3)
    		•
    § 40.3 LIST OF DEFINITIONS  (See separate document)
    § 40.5 WHO HAS FINAL AUTHORITY OVER THESE REGS
  • ODAPC (Office of drug & Alcohol Policy & Compliance) is final authority.
  • OCG (Office of General Counsel) issues written interpretations.
  • HHS now has "technical oversight" instead of SAMHSA.
  • SAMHSA and NIDA are no longer involved & are NOT mentioned in new regs.
  • SAMHSA and NIDA are no longer in the DFW "slang" or work vocabulary.
    		•
    § 40.7 EXEMPTIONS
  • §40.7 cites procedure for applying.
  • Exemptions are granted rarely & narrowly (only for defined provisions.)
  • Regs emphasize difference between "waiver" and "exemption."
    		•

    CONFIDENTIALITY
    [Sub Part P]

    § 40.321 THE GENERAL CONFIDENTIALITY RULE:
    No release of information without specific donor consent.
    No "blanket consents."
    Specific means for specified information for specified occasion.
    § 40.323 Employers may now release subpoenaed information to civil or criminal courts WITHOUT DONOR'S CONSENT.  The information should be released ONLY to the ultimate decision maker (e.g. judge) with written proviso that use should be limited.
    § 40.129 
         (f) (1)    		 Note that stand down waiver does NOT change confidentiality rules! 
  • The waiver permits "stand down" only.
  • The waiver does NOT authorize DER to know test results.
  • Test result or name of drug STILL CONFIDENTIAL till MRO verification.
    		•
    § 40.327
        &
    § 40.135 
         (d) (3)    		 IF MRO BELIEVES A SAFETY HAZARD EXISTS:
    LIMITS OF DONOR CONFIDENTIALITY ARE RE-DEFINED.
  • If medication(s) are involved, MRO has new duties: 
  • 1.  Get donor consent and contact prescribing physician. 
  • 2.  Determine if an alternative medicine can be used to avoid disqualification. 
  • MRO now MUST release donor information WITHOUT donor consent to:
    		•
    1  The Employer under whose policy or rules the test was ordered. 
               (MRO MUST report this unprompted)
    2  A SAP evaluating the donor as part of the RTD process. 
                (if requested)
    3   DOT or another Federal or State safety agency as required by law. 
                (if requested)
                  4  Note that §40.135 makes notifying the Employer an IMPERATIVE!  [Duty!]
  • NOTE §40.327 (above) & §40.135 recite EXCEPTIONS 
    		•
    > §40.321 is still the "general confidentiality rule."
          > Employers and MRO's are STILL PROHIBITED from releasing donor's information to a different employer or to any database or "tracking" organization without consent!
    > Except as provided in §40.325 & §40.135 as above, §40.321 prohibits release of info without donor consent.
    § 40.329 EMPLOYEE ALWAYS HAS RIGHT TO HIS/HER TEST RESULTS!
    If employee (donor) requests:
  • Lab must release all results (within 10 days) including "litigation package."
  • MRO must release all results (within 10 days.) including "quants."
  • SAP must release all results (within 10 days.)
    		•
    § 40.331 INFO RELEASES REQUIRED OF EMPLOYERS & SA's:
    With donor consent:
  • Employer must comply with donor request for release to third party.
  • Prospective or former employers are an example of such requests.
  • Employer must comply with request by any DOT agency.
  • Employer must make his facility available to any DOT agency for inspection.
  • SA's must also comply with request by any DOT, Federal, or state agency.
  • SA's must also make facility available for inspection.
  • Labs are NOT TO RELEASE SPECIMENS to any authority.
    		•
    § 40.333 RECORDS KEEPING REQUIRED OF EMPLOYER
    Five years required for:
  • Non negative drug test results.
  • Alcohol results of 0.02 or greater.
  • SAP reports.
  • Follow up tests and schedules for follow up tests.

    • Three years required for:
  • Info from prior employers under §40.25.

    • Two years required for:
  • Calibration & maintenance records on EBT's.

    • One year required for:
  • Negative and canceled drug and alcohol test results.

    • SA MAY maintain records for employer; ...but
  • Records must be available within 2 days.
    		•
    § 40.167 
         (All)    		 New Regs for reports from MRO to Employers or C/TPA's
    1. Security means are specified for both telephone and electronic transmissions.
    2. Confidentiality is the focus of the entire section. 
    3. Security is required for transmission, handling AND storage of all test results.
    4. "Quants" rule is unchanged: NO QUANTS TO EMPLOYERS OR C/TPA's.

    EMPLOYERS
    [Sub Part B]

    § 40.3 NEW DEFINITION AND "JOB DESCRIPTION"
    DER = Designated Employer Representative.
    Replaces older term of "contact person."
    Must have authority to remove employee from safety sensitive duty.
    >  The full definition of the DER is: An employee authorized by the employer to take immediate action(s) to remove employees from safety sensitive duties and to make required decisions in the testing and evaluation processes.  The DER also receives test results and other communications for the employer, consistent with the requirements of this part.  Service agents CANNOT act as DER's.
    >  The DER receives both negative AND non-negative test results.
    >  An Employer may have more than one DER.  [As many as needed]
    § 40.11
         (b)    		 New regs emphasize and codify prior guidance regarding service agents:
    Employer is responsible for ultimate compliance and reports of all service agents
  • Employer MAY delegate functions to collectors, MROs, TPAs & others.... but...
  • Such agreements (by law) imply compliance with all DOT regs and guidance!
  • Employer is responsible for compliance of their work... and...
  • Employer also responsible for acquiring, filing, and retaining all required reports!
  • THIS PROVISION NOW CRITICAL because of new P.I.E. provisions.
    		•
    § 40.3 STAND DOWN is a new term created & defined by the new regs.
    Exact definition is: The practice of temporarily removing an employee from safety sensitive functions based only on a report from a laboratory to the MRO of a confirmed non negative test BEFORE the MRO has completed verification of the test result.
    § 40.131 
         (d) (2)    		 DER's minimum effort to notify an employee of requirement to contact the MRO:
  • DER must make minimum of 3 "reasonably spaced" calls over 24 hours.
  • If unsuccessful, DER MUST provide a VM, e-mail, or letter for employee.
  • DER MUST also notify MRO of "failed attempt."
    		•
    § 40.21 When DER is notified by MRO that an employee requires an MRO interview:
  • New regs define prohibition AGAINST standing down employees without a waiver.
  • DER expedites contact between employee and MRO  ....BUT, without a waiver...
  • DER takes NO OTHER ACTION till MRO verifies test results.
    		•
    § 40.21 CAVEAT !!!!! There is already confusion about "stand down waiver."
  • This terminology is easy to interpret "backwards" and cause errors.
  • STANDING DOWN EMPLOYEES IS ILLEGAL until MRO verification.
  • It is the WAIVER which allows stand-down prior to verification by MRO.
    		•
    § 40.23 New regs re-emphasize the Bottle B "procrastination" problem.
  • A donor request for a Bottle B re-test DOES NOT allow him/her to stay on the job.
  • Removal from safety sensitive duty is IMMEDIATE with verified positive test.
  • Removal from duty is also IMMEDIATE with adulterated or substituted results.
  • Removal from duty is also IMMEDIATE with ANY "refusal to test."
  • Bottle B request MUST NOT BE USED FOR PROCRASTINATION!
  • There have been abuses and misunderstandings of this rule.
    		•
    § 40.23 
       (e) and
    § 40.197    		 New regulations change action required for "NEGATIVE DILUTE" specimen.
  • As before, such results are VALID and become part of the employee's record.
  • New rules eliminate the option of a witnessed collection at next testing occasion.
  • Employers still have option of requiring re-collection but policy must be uniform!
  • Employers NO LONGER have option of witnessed collection at next test.
    		•
    § 40.23 
       (e) and
    § 40.197    		 MORE ABOUT "NEGATIVE DILUTE" SPECIMENS!
    IF an employer elects to require re-collection for "negative dilute" results:
    1. Employer must enforce this policy uniformly!
    2. Second collection should be UNannounced... because...
    3. Result of the second specimen becomes the test of record!
    4. No more "repeated testing till not dilute!"
    § 40.103 No more blank (QC) specimens required for employers under 2,000 employees.
  • C/TPA's also exempt if their pool contains fewer than 2,000 covered employees.
  • Section 40.103 recites new requirements for those over 2,000.
    		•
    § 40.323 Employers may now release subpoenaed information to civil or criminal courts WITHOUT DONOR'S CONSENT.  The information should be released ONLY to the ultimate decision maker (e.g. judge) with written proviso that use should be limited.
    § 40.333 RECORDS KEEPING REQUIRED OF EMPLOYER
    Five years required for:
  • Non negative drug test results.
  • Alcohol results of 0.02 or greater.
  • SAP reports.
  • Follow up tests and schedules for follow up tests.

    • Three years required for:
  • Info from prior employers under §40.25.

    • Two years required for:
  • Calibration & maintenance records on EBT's.

    • One year required for:
  • Negative and canceled drug and alcohol test results.
    		•

    CONSORTIA & TPA's
    [Sub Part Q]

    § 40.341 New regs define "Service Agent" (SA) as follows:
    Any person or entity, other than an employee of the employer, who provides services specified under this part to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs and STTs, laboratories, MROs, substance abuse professionals, and C/TPAs.
    § 40.3 New regs finally define C/TPA & specify accountability.
    DEFINITION: A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers' drug and alcohol testing programs. This term includes, but is not limited to, groups of employers who join together to administer, as a single entity, the DOT drug and alcohol testing programs of its members. C/TPAs are not "employers" for purposes of this part. 
    § 40.341 Some defining requirements are:
  • C/TPA is an SA performing several functions for employer(s.)
  • Regs seem to define all SA's by means of entitlement to transmit reports.
  • See § 40.345 below.
    		•
    § 40.341 All service agents must comply with all provisions of Part 40!
    § 40.343
    § 40.11    		 What tasks may Employer delegate to an SA?
  • Any or all tasks needed to comply with Part 40.
  • Employer may delegate tasks but NOT responsibility for compliance.
    		•
    § 40.345 C/TPA's & SA's may transmit reports to employers ONLY IF:
  • Employer wishes SA to be an intermediary instead of receiving directly.
  • The report is listed in Appendix F.
  • The report complies with all provisions of Part 40.
    		•
    § 40.345
       & App. F    		 Appendix F lists the following that MAY BE reported through an SA:
    (§ Section numbers indicate provisions that must be followed.)
    §40.25  Previous two years' test results.
    §40.35  Notice to collectors of contact information for DER.
    §40.61(a)  Notification to DER that an employee is a "no show" for a drug test.
    §40.63(e)  Notification to DER of a collection under direct observation.
    §40.65  Notification to DER of a refusal to provide a specimen or an insufficient specimen.
    §40.73  Transmission of employer copy of CCF to DER.
    §40.111  Transmission of laboratory statistical report to employer.
    §40.129  Report of verified test results to DER.
    §40.129  Report to DER of confirmed positive test in stand-down situation.
    §40.149  Report to DER of changed test result.
    §40.155  Report to DER of dilute specimen.
    §40.159  Reports to DER that a test is canceled.
    §40.187  Reports to DER concerning the reconfirmation of tests.
    §40.191  Notice to DER concerning refusals to test.
    §40.199  Report to DER of canceled test and direction to DER for additional collection.
    §40.215  Notice to BAT's and STT's of contact information for DER.
    §40.241  Notification to DER that an employee is a "no show" for an alcohol test.
    §40.247  Transmission of alcohol screening test results only when the test result is less than 0.02.
    §40.255  Transmission of alcohol confirmation test results only when the test result is less than 0.02.
    §40.263  Notification of insufficient saliva and failure to provide sufficient amount of breath.
    § 40.345 Specifically FORBIDDEN by the regs and Appendix F are the following:
    1.  Transmission of lab test results to MRO's.
    2.  Transmission of medical info from MRO to employer.
    3.  Transmission of SAP reports to employers.
    4.  Transmission of positive alcohol test results.
    § 40.347 TPA's MAY perform the following functions for employers:
  • Operate random testing programs.
  • Combine employees into a consortium.

    •        Must use highest random rate if "combining modes."
           Non DOT employees may not be in DOT pools.
  • Assist with SAP-ordered follow up testing plans.
    		•
    § 40.349 What records MAY an SA maintain?
  • Any and all necessary to document the SA's functions.
  • Employer may delegate records keeping to SA.
  • If serving as "intermediary," must get reports promptly to employer.
  • Must follow same protocol and regs as employer: §40.333
  • No donor consent required to receive & maintain these records.
    		•
    § 40.351 Confidentiality requirements for service agents:
  • Must follow same rules as for employers: §Entire Sub Part B.
  • No "blanket" consent forms.
  • Must provide security and prevent unauthorized access.
    		•
    § 40.353 RULES GOVERNING MRO's AND OTHER SERVICE AGENTS
  • Other SA's may provide MRO service via MRO-Employee or Contracts.... but
  • MRO service must meet all requirements of part 40.
  • Employed or contracted MRO's must operate independently & confidentially.
  • Employees may handle MRO documents ONLY if under MRO supervision.
  • Staff absolutely may NOT do verifications or donor interviews!
    		•
    § 40.355 12 NEW COMMANDMENTS FOR C/TPA's AND SA's
    THOU SHALT NOT...
    1  ...Require donor to sign a release, waiver or indemnification.
    2  ...Serve as intermediary between Lab and MRO.
    3  ...Transmit unverified lab results to any third party.
              [All test results must first pass through MRO]
    4  ...Serve as intermediary for alcohol results above 0.02.
    5  ...Receive or transmit SAP reports.... except...
         SAP reports for self employed persons.
    6  ...Make decisions to do reasonable suspicion, post-accident, RTD, and Follow-up tests... except.... for self-employed persons. 
    7  ...Make a determination of "refusal to test" ....except for a self-employed person who fails to show up for a required test which you have scheduled.
    8  ...Function as a DER.
    9  ...Send CCF copies 2, 3, 4, or 5 to the laboratory!
    10  ...Impose conditions or requirements on employers unless specifically called for in Part 40 or DOT modal agency regs.
    11  ...Delay transmission of test results or other documents because of payment disputes or other reasons.
    12  ...Forget that your failure to implement any aspect of the DOT program places your employer-client at risk for DOT enforcement action.

    COLLECTORS & COLLECTIONS
    [Sub Parts C, D, & E]

    § 40.31 COLLECTORS:
  • Must meet training requirements of §40.33.
  • MAY not be an employee of the lab which does test.
  • ALL collectors must complete all training requirements.

    •       Even licensed medical professionals must comply with §40.33.
             [No "automatic collectors" e.g. Physicians, RN's, etc.]
  • No grandfathers after January 31, 2003.
    		•
    § 40.33 Collectors must be knowledgeable in all areas of Part 40.
  • Must also know DOT agency regs for those "modes" s/he serves.
  • Must master: "DOT Urine Specimen Collection Procedures Guidelines."

    •      Revised version has been promised (at www.dot.gov) but is not yet posted.
  • Must keep current with changes in Part 40 or modal regs & guidance.
    		•
    § 40.33 New regs define CORNERSTONES of collector training:
    1. Qualification Training.  (This means a "course" & passing exam.)
    2. Initial Proficiency Demonstration.  (IPD)
    3. Refresher training at least every 5 years.
    4. Error Correction Training (ECT) required for fatal or uncorrected flaws.
    § 40.33 Schedule or "timeline" for Collectors to comply:
  • All collectors should review this paragraph & schedule compliance.
  • Remember: No grandfathers/mothers after 1/31/03.
    		•
    § 40.35 Employers must identify DER for collectors.
  • Collector must be given name and phone number of DER.
    		•
    § 40.41 COLLECTION SITE
  • Must meet physical and security requirements of §40.43.
  • May use moist towelettes if no water source available.
    		•
    § 40.43 COLLECTION SITE SECURITY
  • Inspection between collections to search for possible adulterants.
  • Maintain water source security.
  • Entire site (even nooks & crannies) must be secure.
  • Must prevent unauthorized entry into collection & specimen storage areas.
  • Must minimize number of persons handling specimens!
    		•
    § 40.45 CUSTODY AND CONTROL FORM (CCF)
  • New 5-part form is REQUIRED after August 1, 2001.
  • Extraneous info (such as billing info) is limited to outer borders only.
  • MRO info (block 1-B) must have specific MRO name & address.
    		•
    § 40.45 DISTRIBUTION OF COPIES OF NEW 5-PART CCF
  • COPY 1: (all white): To laboratory with Specimen
  • COPY 2: (white with pink edge): To MRO
  • COPY 3: (white with yellow edge) Collector keeps
  • COPY 4: (white with blue edge): To Employer
  • COPY 5: (white with green lower edge):  To Donor
    		•
    § 40.49 COLLECTION KITS (AND THEIR USE) IS UNCHANGED
  • Prior rules and guidance still apply.
  • Labs will need to re-supply CCF's but NOT collection kits or air-bills.
    		•
    § 40.51 PACKAGING AND SHIPPING OF SPECIMENS
  • Rules essentially unchanged except for one exception:
  • No container required if lab courier delivers direct to lab.
    		•
    § 40.61 URINE SPECIMEN COLLECTION ~ PRELIMINARIES:
  • Failure of employee or owner/operator to show up is "refusal to test!"
  • If alcohol test is also required, DO ALCOHOL TEST FIRST.
  • Self catheterization is allowed for donors who normally void this way.
  • Collector must explain collection process to donor.
  • Back of CCF is designed (and considered adequate) for this explanation.
  • Donor must remove all items from his/her pockets!

    •      > Witnessed collection required if potential adulterants or "substitute" found. 
       >If such materials deemed "inadvertent," items must be secured till specimen sealed.
       >If no suspicious pocket contents, donor may return all items to his/her pockets.
    § 40.63 SPECIMEN COLLECTION ~ MORE PRELIMINARIES:
  • Donor MAY (probably should) select the collection kit.
  • Donor may take ONLY the collection container to the room for urination.
  • Donor is instructed NOT to flush the toilet.
  • Collection site may set a time limit for a person to void.
  • Behavior  suggesting attempt to tamper or cheat requires a witnessed collection!
    		•
    § 40.65 COLD, HOT, AND "FUNNY" SPECIMENS:
  • Protocol for these specimens is UNCHANGED with one exception:

    •    > Collector no longer needs to take donor's temperature!
  • Such specimens are still submitted to lab as in the past... AND...
  • An immediate WITNESSED re-collection is required!
  • If collector notices unusual appearance, or odor, same rules apply.
    		•
    § 40.67 DIRECTLY OBSERVED ("WITNESSED") SPECIMENS:
    REQUIRED BY EMPLOYER DIRECTIVE IF:
  • 1. MRO has reported "invalid" result on prior test.
  • 2. A split specimen test had to be canceled. (No Bottle B.)

    •       In these cases, Employer must explain (to donor) the reason for direct observation.
    REQUIRED BY COLLECTOR DIRECTIVE IF:
  • 3. Specimen temperature is out of range or appears abnormal to the collector.
  • 4. Donor behavior or sounds etc. suggest an attempt to tamper or substitute.

    •       In these cases, the Collector must explain the reason to the donor
    § 40.67 RULES FOR DIRECTLY OBSERVED COLLECTIONS:
  • Always use a new CCF for the observed collection.
  • Check the same "reason box" as for the initial test.
  • Check the "observed" box and enter the reason in the remarks section.
  • If sending 2 (linked) specimens, indicate "1 of 2" and "2 of 2" on the CCF.
  • The observer must be the SAME GENDER as the donor.
  • The observer need NOT be the collector.  If not the collector:

    •      1. The observer may NOT handle the specimen... and
         2. The observer's name should be written in the CCF "remarks" field.
  • If donor refuses to allow a required observation, this is a "refusal to test."
    		•
    § 40.69 MONITORED COLLECTIONS:  (Prior "guidance" is now "regs.") 
  • Monitoring is required for certain types of rest room arrangements.
  • Multi-stall and similar arrangements will require use of these rules.
  • Monitor must be EITHER same gender or a licensed medical professional.
  • If donor refuses a monitored collection, this is a "refusal to test."
    		•
    § 40.71 DONOR SIGNATURE:
  • Donor must sign both seals AND the donor certificate. (step 5.)
  • If donor refuses or if forgotten, Collector must note this in remarks field of CCF.
  • Donor name MUST be printed legibly ALWAYS! -- even if s/he refuses to sign.
  • Remember: This is the only means the MRO has of entering the donor name

    •                            The lab is "blind" to the donor name!
    § 40.73 COMPLETING THE COLLECTION PROCESS:
  • Only  Copy 1 accompanies the specimen to the lab.
  • The actual name of the delivery service must be entered on the CCF.
  • MRO copy (Copy 2) must faxed or transmitted to the MRO within 24 hrs.
  • DER copy (Copy 4) must also be faxed or transmitted within 24 hrs.
  • Collector copy (Copy 3) must be kept 30 days unless modal regs specify longer.
  • Specimen itself must be shipped within 24 hrs. (or next business day)
    		•

    LABORATORIES
    [Sub Part F]

    § 40.81 
       (b) (1) (2)    		 Canadian and Mexican Labs may qualify to do DOT lab work... IF:
  • DOT approves the lab based on HHS assurance of the lab's quality.... OR...
  • DOT approves the lab based on HHS assurance of the lab's "sister certifying body."
    		•
    § 40.81
        (c) (d)    		 Laboratories will be subject to P.I.E. proceedings EVEN THOUGH they are also subject to NLCP sanctions.  DOT does NOT consider this double jeopardy.  P.I.E.'s will not be issued for matters covered by HHS inspections; but only for other matters such as reporting infractions, etc.
    § 40.83 
        (c) (1-4)
    § 40.199    		 WHAT ALWAYS CAUSES "REJECTED" RESULT?
    List of "FATAL FLAWS" is modified as follows:
    1. Specimen ID on bottles and CCF do not match.
    2. Tampered or broken seal  (unless correctable via re-designation.)
    3. Collector's printed name AND signature are omitted.
    4.  Insufficient urine in primary bottle (unless correctable via re-designation.)
              On such specimens, Lab report to MRO will now read "rejected."
                        MRO report to Employer will read "canceled."
    § 40.83 
         (g)-(h)    		 Lab may now "RE-DESIGNATE" (switch) Bottles A and B.
  • A logical set of reasons is quoted in text.
  • The swap itself does NOT call for opening either specimen or breaking either seal.
  • Accessioner who does swap must re-label BOTH specimens.
    		•
    § 40.85 Despite controversy, the 5 panel list of drugs will remain the same.
    § 40.87 The screening and confirmation cutoffs will remain the same. 
  • (See table under 40.87.)
  • New "burden of proof" cutoff of 15,000 ng/ML for Opiates.
    		•
    § 40.89 As of 8/1/01, ALL LABS MUST conduct VALIDITY studies !
  • This includes studies for both adulteration and substitution! 
  • HHS criteria must be followed in doing this testing. 
  • Prior to 8/1/01, adulteration studies were optional.
    		•
    § 40.91 -
       §40.95    		 Definitions for dilute, substituted, and adulterated remain the same!
  • However MRO action is now required for substituted and adulterated results.
  • How to remember: Donor's right to interview and Bottle B retest are re-instated.
    		•
    § 40.97 
        (a)    		 Reporting Nomenclature has been revised. (again!) 
    The new "set of possible results" is: 
    Negative, Negative-dilute, Rejected, Positive-dilute, Adulterated, Substituted, and Invalid.
  • Positive AND dilute is a new requirement.
  • Rejected is a new term.  (Used instead of "canceled" for a fatal or uncorrected flaw.)
  • Invalid is a new term.  (Formerly was "unsuitable.")
    		•
    § 40.97 
        (b)    		 The new regs are much more assertive about reporting results to non MRO's:
  • Results must be transmitted directly and ONLY to MRO at his place of work.
  • Reporting to (or through) C/TPA or DER is specifically forbidden.
    		•
    § 40.97 
       (preamble)    		 Preamble is even more assertive regarding this reporting rule:
    "There is only one party in the DOT testing system who is entitled to see a confirmed result. That is the MRO. ...TPA's are not."
    § 40.97
         (f)    		 Lab MUST report quantitative opiate levels to MRO if above 15,000 ng/mL.
  • This is because of the new "burden of proof" cut-off of 15,000.
  • Below this quant level, the old rules apply.
    		•
    § 40.101 Laboratories no longer allowed to recommend MRO's to customers.
  • Even a "slate" of recommended MRO's is now forbidden.
  • Labs must now refer queries for an MRO to the "national" locator pages & lists.
    		•
    § 40.103 No more blank (QC) specimens required for employers under 2,000 employees.
  • C/TPA's also exempt if their pool contains fewer than 2,000 covered employees.
  • Section 40.103 recites new requirements for those over 2,000.
    		•
    § 40.111 Statistical summaries (formerly called "quarterlies") are now semi-annual.
  • Reporting deadlines are Jan 20 (for July-Dec) and July 20 (for Jan-July.)
  • No reports if fewer than 5 employees or if no tests done for a given employer.
    		•

    MEDICAL REVIEW OFFICERS
    [Sub Part G]

    § 40.121 
         (a)    		 Regulations now state clearly that Canadian and Mexican physicians may serve as MRO's as long as they meet all requirements.   Canadian and Mexican MRO's may review tests for US companies... and vice versa.
    § 40.121 
         (a)    		 Regulations now fully assert prior guidance that MRO's may NOT be limited geographically.  Although they must be licensed in their own state or province, they may review drug test results for employers and employees in ANY state or province.  DOT "pre-emption" rules, and the assertion that MRO functions are NOT the practice of medicine, are quoted (in the pre-amble) as the basis for this provision.
    § 40.121 
         (d)    		 Qualification training is now REQUIRED for MRO's.  Best translation at present is that they must be "certified" (successfully complete the exam by January 31, 2003) by either MROCC or AAMRO.  DOT emphasizes that this is NOT DOT CERTIFICATION... i.e. that MRO's and other service providers may NOT falsely advertise that they are "DOT Certified."
    § 40.121 
         (d)    		 Continuing education is now required for MRO's. 
  • 12 CME hours are now required every three years.
  • The regulations DO NOT MENTION RE-CERTIFICATION.
    		•
    § 40.121
         (e)    		 MRO must maintain documentation of qualifications and training which meet DOT criteria.  MRO documentation must be provided to employers, C/TPA's or DOT agencies upon request.
    § 40.123 
         (d)    		 New regs emphatically re-assert the prior guidance on MRO's.
  • MRO-donor interactions ARE NOT A DOCTOR- PATIENT RELATIONSHIP. 
  • The MRO is seen by the DOT as NOT "practicing medicine."
    		•
    § 40.127 
         (c) (2)    		 Hard lab copy of CCF is no longer necessary for MRO to verify & release negative results. 
  • Fax or electronic version of the laboratory report is sufficient.
  • Report must convey ALL the required information.
    		•
    § 40.129 
         (f) (1)    		 MRO actions regarding reporting of confirmed lab positives PRIOR TO VERIFICATION are now subject to the "stand down" provisions of §40.21 for employers who have a "stand down waiver." 
  • The waiver permits "stand down" but does NOT authorize DER to know test results.
  • Test result or name of drug STILL CONFIDENTIAL till MRO verification.
    		•
    § 40.131 
         (a) & (b)    		 Revised regs re-emphasize that donors with positive, substituted, adulterated, or invalid test results are REQUIRED to speak to the MRO regarding their test results.  The new regs clarify the language permitted by the MRO and his staff during contact with the donor:
  • MRO STAFF MUST advise donor of REQUIREMENT to speak with the MRO.
  • MRO STAFF MUST NOT ASK DONOR  "Do you wish to speak with the MRO?" 
  • The MRO himself MAY ask this question  after required preliminaries.
    		•
    § 40.131 
         (c)    		 The rules for contacting lab-positive donors are changed and will now require:
  • Three (instead of 2) "reasonably spaced" calls over a 24 hour period 
  • MRO uses BOTH phone numbers given on the CCF.
  • DER is to be contacted if this effort fails... 
  • OR if both phone numbers prove to be fraudulent, disconnected, etc.
    		•
    § 40.133 
         (all)    		 New rules for verifying a "positive" or "refusal to test" WITHOUT an MRO interview:
    1. The donor expressly declines an interview after being told it is required.
    2. 72 hours pass after the donor is notified by the DER of requirement to call MRO
    3. 10 days pass & prescribed MRO and DER attempts to reach the donor have failed.
    4. 60 days is then allowed for the donor to contact the MRO with "explanations" to re-open the verification process.
    § 40.135 
         (d) (3)    		 IF MRO BELIEVE SAFETY HAZARD EXISTS:
    LIMITS OF DONOR CONFIDENTIALITY ARE RE-DEFINED
  • If medication(s) are involved, MRO has new duties: 
  • 1.  Get donor consent and contact prescribing physician. 
  • 2.  Determine if an alternative medication can be used to avoid disqualification. 
  • MRO now MUST release donor information WITHOUT donor consent to:
    		•
    1  The Employer under whose policy or rules the test was ordered. 
               (MRO MUST report this unprompted)
    2  A SAP evaluating the donor as part of the RTD process. 
                (if requested)
    3   DOT or other federal or state safety agency as required by law. 
               (if requested)
                  4  Note that §40.135 makes notifying the Employer a DUTY!
  • NOTE §40.135 (above) recites ONLY EXCEPTIONS 
    		•
    > §40.321 is still the "general confidentiality rule."
    > Employers and MRO's are STILL PROHIBITED from releasing donor's information to a different employer or to any database or "tracking" organization.
    > Except as provided in §40.135 as above, 
    §40.321 prohibits release of info without donor consent.
    § 40.137 
         (c)    		 MRO has the discretion (at the time of a donor interview) to grant a donor up to 5 days to gather information IF AND ONLY IF the donor convinces the MRO that s/he will be able to carry the burden of proof of a legitimate medical explanation for the lab findings.
    THE GENERAL RULE REMAINS:
           >>The donor must meet the burden of proof at the time of the interview.
    § 40.137 
         (e)    		 Specific guidance is recited regarding medications obtained in a foreign country.
    This claim MAY be accepted by the MRO as a legitimate explanation for a laboratory finding of Amphetamines, Cocaine, Marijuana, PCP, and/or opiates above 15,000 ng/mL... but only if three cited criteria are met:
    1. It must have been obtained LEGALLY in the country where obtained.
    2. It must have a legitimate medical use.
    3. Use must be consistent with a proper and intended medical purpose.
    GUIDANCE in the preamble actually infers that the MRO's decision might also hinge on the question of whether consultation with a US physician should have or did or did not occur at any time during use of the drug in the US as would be appropriate for the medical condition for which the donor is using the drug.
    § 40.139  A NEW "BURDEN OF PROOF" CUT-OFF for Opiates: 15,000 ng/ML
    1  Do not confuse this with the gc/ms confirmatory cut-off of 2,000 ng/mL which remains the same.
    2   Above 15,000 ng/mL, the "burden of proof" shifts to the donor to provide a "legitimate medical explanation."
    3   Below 15,000 ng/mL, the "burden of proof" is still with the MRO; and clinical evidence is still necessary.
    4  Except for an admission (which is "clinical proof") DOT specifies that the words "clinical proof" imply a face to face interview and physical examination.  However, as before, the new regs DO NOT REQUIRE an examination to occur.
      The system will continue to allow an unknowable number of Opiate abusers to go undetected because of the concessions that have to be made for use of poppy seeds and because the yield of "clinical findings" on physical examinations is notoriously low.
    § 40.145
         (d)    		 FOR CONFIRMED "ADULTERATED" AND "SUBSTITUTED" RESULTS:
    New regs assert the donor rights to an MRO interview AND to a bottle B "re-test."
    This provision is in effect as of 1/18/01! 
    Prior to 1/18/01, donors with these results were denied the benefit (?) of an MRO interview and/or re-test.
    Approached by the MRO exactly like a "drug positive" result:
    1  The MRO MUST offer the donor the opportunity to provide a legitimate medical explanation.
    2  The donor has the burden of proof to provide a legitimate explanation for such specimens.
    3  There are ZERO known scientific explanations for human urine meeting these criteria.
    4  MRO's are calling this provision "wish management" and other (worse) names.
    5  The entire provision is new and should be read and understood by MRO's.
    6  DOT has created this provision (for "fairness") even though it is virtually impossible for human urine to have the characteristics required for these categories (adulterated and substituted.)
    § 40.145 (3) This provision is thought to be the provision MRO's will rely on in their actual practice of the trade. 
    The key words are: "...a reasonable basis to believe that the employee will be able to produce relevant evidence..." 
    It is expected that most MRO's will NOT "believe" that the employee will be able to produce such evidence; and will, as a practice, notify the employee of the "Bottle B" retest right, and continue to verify and report these results without granting the 5 day information gathering period.
    § 40.153 (All) NEW FIVE POINT PROTOCOL for the MRO's "reading" of the donor's Bottle B rights:  The MRO must:
    1  Advise the employee of the procedures for requesting the "re-test."
    2  Notify the employee that s/he has 72 hours to request the "re-test."
    3  Give the employee any & all info needed to contact the MRO within 72 hours.
    4  Advise employee that employer is financially obligated to see that the test is done promptly... however... Employee is also notified that the employer is permitted to seek reimbursement for the cost of the test.
    5  Advise the employee that additional tests of the specimen (e.g. DNA) are not authorized.
    § 40.149 (All) NEW SECTION provides 60 day period for MRO to change results and recites strict rules for doing so.
    1  Verification can be "re-opened" via 40.133 for donor who was explainably unavailable for interview when sought.
    2  Result can be changed or verification (re)opened for discovery of a technical or clerical error at the laboratory.
    3  Result can be changed if credible new evidence is brought to light.
    4  After 60 days, MRO may not change a verified result unless consulting with ODAPC first.
    5  ONLY THE MRO may change a verified test result.
    § 40.151 
         (All)    		 TEN NEW COMMANDMENTS FOR THE MRO during the verification process:
    THOU SHALT NOT:
    1  ...consider any test results or evidence which is not obtained in accordance with "this part" (these rules.)
    2   ...consider evidence extrinsic to the actual CCF.  (Thou shalt read what is before thee regardless of what  someone may say about what actually happened at the collection site)
    3  ...consider whether a given donor was correctly "selected" a given test.
    4  ...accept the claim of "accident" or "inadvertency" 
        e.g. "someone put the proscribed substance in my drink..."
    5   ...accept the claim that a Schedule I or other illegal substance was prescribed by a physician.
    6   ...accept the claim of "medical Marijuana" ...even in states where state law allows it.
    7  ...accept the claim of "hemp" products, "coca teas" or other products known to contain proscribed substances.
    8  ...accept ANY "medical explanation" for PCP or 6-AM.
    9  ...accept the claim that an adulterant such as soap, bleach or glutaraldehyde reached the bladder physiologically.
    10  ...accept the claim that a donor is able to produce urine with no detectable creatinine.
    § 40.159 
         (All)    		 NEW TERM AND PROTOCOL FOR THE MRO: "INVALID"
    For  understanding the MRO's job, the handiest definition of "invalid" is: containing a substance which, by inference, could be an interfering medication but could also be caused by donor mischief, but unable to be identified by the lab in a forensically defensible way.
    §40.159 = NEW MRO PROTOCOL FOR "INVALID" RESULTS: 
               MRO MUST DO ALL THE FOLLOWING:
    1. Discuss the results with a certifying scientist at the lab.
    2. Discuss the results with donor seeking a valid explanation of the results.
    3. REPORTING RULES:
         "Explained" Invalids:
                 verified as "Canceled - Invalid - No re-collection"
         "Unexplained" Invalids:
                 verified as "Canceled - Invalid - Dir. Obs. Re-collection required."
     [To learn exact mechanics, read the rule with the new 5-part CCF in hand.]
    § 40.163 
         (All)    		 MAJOR CHANGES in MRO reporting mechanics result from the new re-designed 5-part CCF.
    1. Minor changes in terminology required for compliant use of electronic reporting.
    2. New reporting system best learned by reading §40.163 with the new CCF in hand.
    3. Quant rule still in force: QUANTS ARE NEVER RELEASED TO EMPLOYERS.
    § 40.161 ANOTHER NEW TERM AND CHORE FOR THE MRO:  "REJECTED"
    1  The term "rejected" indicates that the lab found a fatal or uncorrected flaw... usually clerical or procedural.
    2  This clarifies an older confusion regarding the word "canceled."
    3   Now instead of "canceling" a test, the lab uses the word "rejected" ...and "canceled" is reserved for the MRO.
    4  Rejected tests are canceled by the MRO and reported as "Canceled."
    5  A legible "copy 1" AND a CCF copy with donor's signature is required for this action.
    6   Re-collection is required ONLY if a negative test result is required by the employer.  (e.g. pre-employment.)
    § 40.165 
         (All)    		 New Regs resolve issue of reporting test results to employers through a C/TPA.
    1. This practice is permitted and is the OPTION OF THE EMPLOYER.
    2. Reports transmitted to (through) a C/TPA must be done in compliance with §40.345.
    § 40.167 
         (All)    		 New rules for transmitting reports from MRO to Employers or C/TPA's
    1. Security means are specified for both telephone and electric transmissions.
    2. Confidentiality is the focus of the entire section. 
    3. Security required for transmission, handling AND storage of all test results.
    4. "Quants" rule is unchanged: NO QUANTS TO EMPLOYERS OR C/TPA's.

    SPLIT SPECIMEN TESTING
    [Sub Part H]

    § 40.83 
        (g)-(h)    		 Lab may now "RE-DESIGNATE" (switch) Bottles A and B. 
  • A logical set of reasons is quoted in text.
  • The swap itself does NOT call for opening either specimen or breaking either seal.
  • Accessioner who does swap must re-label BOTH specimens.
    		•
    § 40.169 Employee request for Bottle B retest must be within 72 hours of Verification interview.
  • Employee request may be oral.
  • MRO request to lab must be "immediate" and in writing.
  • Tardy requests by donor must have "excuse" acceptable to MRO.
    		•
    § 40.173 DOT takes no position on who should pay for the Split Specimen Test
  • Employer MAY ask donor to pay for the test.... however,
  • Employer may not delay the test because of donor insolvency or refusal.
  • Regs do not forbid reporting this donor debt to credit agency.
    		•
    § 40.175 If specimen arrives at lab with "Bottle B" missing:
  • Lab notifies NOBODY... but proceeds with testing & reporting of Bottle A.
  • MRO is notified of missing "Bottle B" ONLY if donor requests a re-test.
  • Lab is to provide "explanation" for missing specimen if they know explanation.
    		•
    § 40.67 New regs require observed re-collection if test of missing Bottle B requested.
  • MRO now directed to pronounce test "canceled" ...AND...
  • Donor required to have UNannounced re-test with direct observation of collection.
    		•
    § 40.175 New regs define impact of inadvertent breach of donor identity rule:
  • If lab inadvertently is sent information on ID of donor, test is still valid!
  • This rule applies also for transmission of documents in Split Specimen testing.
    		•
    § 40.177 &
    § 40.179    		 Second lab tests specimen using same format as an A specimen... EXCEPT...
  • There are no cut-offs (except "Limit of Detection") when reconfirming for drugs.
  • Criteria & definitions for adulteration and substitution are the same.
    		•
    § 40.183 &
    § 40.185    		 Bottle B reporting mechanism is all new and different!
  • Reporting regs now accommodate reconfirmations for substitution & adulteration.
  • Reporting regs now accommodated to new 5 part CCF.
  • Lab may report Bottle B results ONLY to MRO at his place of business.
    		•
    § 40.187 MRO Bottle B reporting mechanism also new and different!
  • MRO must still report results to BOTH employer and donor.
  • New reporting regs accommodate "validity tests" and new CCF.
  • Failures to re-confirm must be reported to ODAPC.
  • Appendix D is reporting form for this report to ODAPC.
    		•

    PROBLEMS IN DRUG TESTING
    [Sub Part I]

    § 40.191
         (a)    		 AT THE COLLECTION SITE:
    New regs define: 8 WAYS to earn a "refusal to test."
    1. Fail to appear "on time" at the collection site.
  • Employer defines what "on time" means. 
  • This is an "employer call!" 
  • Collector may report tardiness to employer... but...
  • Collector may not pronounce donor late!
    		•
    2. Fail to stay until testing process is complete.
      3. Fail to provide a urine specimen as required by these regs.
    4. Refuse to allow direct observation when it is required by these regs.
    5. Fail to produce an adequate specimen after a negative shy bladder work-up.
    6. Refuse to take a "second test" when advised of the requirement to do so.
    7. Refuse or fail to undergo a medical exam when required by these regs.
    8. Misbehave or fail to co-operate with any part of the testing process.
    § 40.191
         (d)    		 "List of 8" above are Collector and/or Employer "Declarations."
  • Whoever makes this "declaration" is responsible and probably liable.
  • Based on §40.355 (j) this appears to be strictly an "Employer call."
  • Collector reports such a "refusal to test" to the DER.
  • Such "declarations" are not reviewed or verified by the MRO... however,
  • May be reported through MRO for completeness of records keeping.
    		•
    § 40.191
         (b)    		 BASED ON LABORATORY RESULTS :
    New regs still define 2 WAYS to earn a "refusal to test"
    1  Adulteration.
    2  Substitution.
    § 40.191
        (c)    		 New regs re-emphasize meaning of "Refusal to test" 
  • Refusal to test is always a violation of DOT regulations.
  • Consequences are now same as "positive" results.
    		•
    § 40.193 Shy Bladder procedures are essentially UNchanged.
  • Collector must discard an insufficient specimen.
  • Three hours and 40 oz of fluid are still allowed to prepare for re-attempt.
  • Regs describe donor/employer option for Physician exam for Shy Bladder.
    		•
    § 40.195 LONG TERM MEDICAL CONDITIONS CAUSING INSUFFICIENT URINE:
    Donor must have long term (not temporary) medical condition.
    Complicated protocol and logic!
    Drug free status must be proved & blood or saliva tests O.K.
    Test "CANCELED" if donor positive for drugs!  (!?)
    Provision rarely used.  Be aware!  ....but no need to Memorize!
    § 40.197
       (a)    		 "POSITIVE DILUTE" Results:
  • New regs require MRO to indicate "dilute" even on positives.
  • This is an acknowledged REDUNDANCY (for statistics only.) (?)
  • Employer treats these as any other positive!
    		•
    § 40.197
      (b)&(c)    		 "NEGATIVE DILUTE" Results:
    Regs still give Employer option to require immediate retest.
  • Such a policy must be uniform and consistent.
  • May not require witnessed collection!
  • Second test MUST become the test of record.
  • NO THIRD TEST if second is also "negative & dilute."

    • New regs rescind older option for Witnessed re-collection.
  • Remember: NO WITNESSED RE-COLLECTIONS FOR DILUTES!
    		•
    § 40.83 
        (c) (1-4)
    § 40.199    		 WHAT ALWAYS CAUSES "CANCELED" RESULT?
    List of "FATAL FLAWS" is modified as follows:
    These are all "Lab calls."
    1. Specimen ID on bottles and CCF do not match.
    2. Tampered or broken seal  (unless correctable via re-designation.)
    3. Collector's printed name AND signature are omitted.
    4.  Insufficient urine in primary bottle (unless correctable via re-designation.)
              On such specimens, Lab report to MRO will now read "rejected."
                        MRO report to Employer will read "canceled."
    § 40.210 "ALWAYS CANCELED" AND SOMETIMES RE-COLLECTED?
    This is a list of "situations" and not "flaws."
    These are all "MRO "calls" except for #3.
    1.  Invalid result "explained" via interview: No re-collection
    2.  Invalid result "unexplained:" UNannounced witnessed re-collection.
    3.  Rejected result: re-collection required only if "negative test" needed.
    4.  Failure to reconfirm (a Split specimen re-test:) No re-collection
    5.  Split Specimen not available when donor requests re-test: 
                   UNannounced witnessed Re-collection required!
    6.  Shy Bladder study explains insufficient specimen:  No re-collection.
    § 40.203 WHAT MUST BE REPAIRED TO PREVENT "CANCELED" RESULT?
    List of "CORRECTABLE FLAWS" is modified as follows:
    1.  Collector's signature is omitted on Certification of CCF.
    2.  Temp box not checked & no relevant entry on "remarks" line.
    3.  Donor signature missing and no relevant entry on "remarks" line.
    4.  Certifying Scientist's signature missing on Copy 1 for non-negative result.
    5.  Non-DOT form is used for DOT test. 
            ("correction" consists of documentation & hoop jumping by collector.)
    § 40.205 HOW ARE DRUG TEST PROBLEMS CORRECTED?"
    "If, as a collector, laboratory, MRO, employer, or other person implementing these drug testing regulations, you become aware of a problem that can be corrected... you must take all practicable action to correct the problem so that the test is not canceled."
    1. If re-collection is needed, it is authorized and should be immediate!
    2. All "players" must co-operate to correct errors.
    3. Always document corrections & requests for corrections on CCF.
    4. One "special error:" Use of Non DOT CCF.
           Correction requires documentation and hoop jumping. [§40.205 (b) (2)]
    5. If errors are not corrected, MRO must "Cancel" test.
    § 40.207 WHAT IS THE EFFECT OF A CANCELED DRUG TEST?
    A Canceled test is neither negative nor positive.
  • May not be used for administrative action (hiring, firing, etc.)
  • May not require a re-collection except where regs require.
  • May not be counted for quota of randoms etc.
  • Does not justify requirement for a non-DOT test.
    		•
    § 40.209 TEN VENIAL SINS
    "No person concerned with the testing process may declare a test canceled based on an error that does not have a significant adverse effect on the right of the employee to have a fair and accurate test."
    --------------------------------------------------------------------------------------------------------------------------------------
    Even though not "fatal" these errors can get you penalized!
    Errors which are problems but insufficient to render a test "canceled."
    1. Minor clerical error such as spelling or transposition of SSN digits.
    2. An error that does not affect donor protections... such as failure to add bluing agent to the toilet bowl.
    3. Collection by a collector who has not met training requirements.
    4. A delay in the collection process.
    5. Verification by an MRO who has not met training requirements.
    6. Failure to witness a collection when called for... or witnessing when not called for.
    7. Collection in a facility which does not meet requirements of 40.41.
    8. Omitted or incorrect courier name.
    9. Inadvertent inclusion of donor name or ID on Lab copy of CCF.
    10. Claims that donor was improperly selected for testing.

    ALCOHOL TESTING
    [Sub Parts J, K, L, M, & N]

    § 40.211 WHO CONDUCTS ALCOHOL TESTS?
  • STT: Saliva Test Techinician.
  • BAT: Breath Alcohol Technician.
  • MAY not be immediate supervisor of person tested.
    		•
    § 40.213 New regs define CORNERSTONES of BAT & STT training:
    1. Basic knowledge
              Info on line at http://www.dot.gov/ost/dapc
    2. Qualification Training.  (This means a "course" & passing exam.)
            Training must be on the actual EBT or AST you will be using!
    3.  Initial Proficiency Demonstration.  (IPD)
    4.  Refresher training at least every 5 years.
    5. Documentation of credentials and CME.
    6. Error Correction Training (ECT) required for fatal or uncorrected flaws.
               All BATS & STT's before 8/1/01 are "grandfathers/mothers" 
    § 40.213 LAW ENFORCEMENT OFFICERS MAY SERVE AS BATs or STT's.
    Must be certified by state or local governments to conduct tests.
    § 40.215 Employers must identify DER for BAT or SST.
  • Collector must be given name and phone number of DER.
  • Also name & number of C/TPA if applicable.
    		•
    § 40.221 ALCOHOL TESTING SITE
  • Must meet physical and security requirements of §40.223.
  • May "stretch" this rule if situation requires for random, post accident, etc.
  • Must always ensure maximum visual and aural privacy.
    		•
    § 40.223 ALCOHOL TESTING SITE SECURITY
  • Access only to authorized persons.
  • BAT or STT site supervision.
  • Removal of persons obstructing or interfering with testing
  • Privacy meeting §§ 40.241-40.255.)
  • Must test only one employee at a time.
  • May not test another employee while awaiting a confirmation.
  • Do not leave testing site except for pressing emergency.
    		•
    § 40.225 WHAT FORM IS USED FOR ALCOHOL TESTING?
    3-part carbonless DOT Alcohol Testing Form  (ATF)
    § 40.227 DOT forms may NOT be used for non DOT testing!
  • If done inadvertently or by necessity; BAT must document [§40.271 (b)]
  • This mistake requires lots of hoop jumping.
    		•
    § 40.231 Confirmation devices (EBT's) must be approved by NHTSA
    Conforming Products List is on line at:
          http://www.dot.gov/ost/dapc/
    § 40.233 Proper use and care of EBT's
  • Must follow manufacturer's instructions.
  • Must perform external calibration checks at specified intervals.
  • Must run an "air blank" with every test!
    		•
    § 40.235 ALCOHOL SCREENING DEVICES  (ASD's)
  • Must also be on NHTSA list (CPL.)
  • Follow instructions for use and care as per QAP.
  • Must pass specified quality control checks.
  • Must have valid expiration date.
    		•
    § 40.241 PRELIMINARIES FOR ALCOHOL TEST (both SSD & EBT)
  • Do alcohol testing before required drug testing.
  • Photo ID is the standard & preferred means of ID.
  • DER may confirm ID if necessary.
  • Explain procedure to employee and show instructions on back of ATF.
  • If employee refuses to sign Step 2, document this & report to DER.

    •               This is a REFUSAL TO TEST!
    § 40.243 PROCEDURE FOR EBT SCREENING TEST IS UNCHANGED.
    § 40.245 PROCEDURE FOR SCREENING WITH ASD IS UNCHANGED.
    § 40.247 0.02 IS CUT-OFF FOR NEGATIVES.  <0.02 REQUIRES CONFIRMATION
  • Confirmation must be with an EBT.
  • Must occur within 30 minutes.
  • Employee must be given explanation and instructions.
  • No eating, drinking, smoking, or belching while awaiting confirmation.
    		•
    § 40.251 PRELIMINARIES FOR CONFIRMATION TEST:
  • Must wait at least 15 minutes... but sooner than 30 minutes!
  • Transit time counts as part of waiting time!
  • Employee must be observed by screening BAT or STT while waiting.
  • Proceed with ID and document ATF re time interval & situation.
    		•
    § 40.253 PROCEDURE FOR CONFIRMATION TEST IS UNCHANGED.
    § 40.255 REPORTING OF RESULTS OF CONFIRMATION TEST:
  • Below 0.02, test is negative.
  • Above 0.02 is a VIOLATION... reportable to DER.
  • If employee refuses to sign step 4...

    •      This is NOT a refusal to test but must be documented.
  • BAT must report a confirmation above 0.02 directly to the DER.
  • These non-negative results MAY NOT be reported to C/TPA or other SA.
    		•
    § 40.261
         (a)    		 AT THE ALCOHOL TESTING SITE:
    New regs define: 7 WAYS to earn a "refusal to test."
    1. Fail to appear "on time" at the testing site.
  • Employer defines what "on time" means. 
  • This is an "employer call!" 
  • BAT or STT may report tardiness to employer... but...
  • BAT or STT may not pronounce donor late! 
    		•
    2. Fail to stay until testing process is complete.
      3. Fail to attempt to provide a breath specimen as required by these regs.
    4. Fail to produce an adequate specimen after a negative shy lung work-up.
    5. Fail to sign certification at step 2 of the ATF.
    6. Refuse or fail to undergo a medical exam when required by these regs.
    7. Misbehave or fail to co-operate with any part of the testing process.
    § 40.261
         (d)    		 "List of 7" above are Employer "Declarations."
  • Whoever makes this "declaration" is responsible and probably liable.
  • Based on §40.355 (j) this appears to be strictly an "Employer call."
  • ONE EXCEPTION: owner operator: This is an SST-BAT call.
  • BAT or STT reports any "refusal to test" to the DER.
  • Such "declarations" are not reviewed or verified by the MRO... however,
  • May be reported through MRO for completeness of records keeping.
    		•
    § 40. 263 FAILURE TO PROVIDE SUFFICIENT SALIVA FOR STT:
  • NOT a refusal to test.
  • STT tries second time, then documents & reports to DER.
  • DER must arrange an immediate test using an EBT.
    		•
    § 40.265 FAILURE TO PROVIDE A SUFFICIENT BREATH SPECIMEN:
  • BAT should work with employee till certain that "more trying" won't help.
  • This "failure" triggers a shy-lung work-up.
  • This is an employer call and employer picks physician.
  • Detailed provisions are cited in §40.265.
    		•
    § 40.267  WHAT ALWAYS CAUSES "CANCELED" RESULT?
    List of "FATAL FLAWS" is modified as follows:
    ASD'S
    1. STT reads results too soon.
    2. Device fails to activate.
    3. Device used post expiration date.
    EBT's
    1. BAT conducts confirmation test without waiting 15 minutes.
    2. BAT fails to conduct air blank.
    3. No 0.00 air blank result prior to confirmation test.
    4. EBT fails to print result.
    5.  EBT test number or alcohol level does not match number on printout.
    6. Next external calibration check produces unsatisfactory result.
    § 40.267 WHAT MUST BE REPAIRED TO PREVENT "CANCELED" RESULT?
    List of "CORRECTABLE FLAWS" is modified as follows:
    1.  BAT or STT does not sign ATF.
    2.  BAT or STT fails to note on "remarks" line that employee has not signed.
    3.  BAT or STT uses non-DOT form for test.
    § 40.271 HOW ARE ALCOHOL TEST PROBLEMS CORRECTED?
    "If, as a BAT or SST, you become aware of a problem that can be corrected...you must take all practicable action to correct the problem so that the test is not canceled."
    1. All "players" must co-operate to correct errors.
    2. Always document corrections & requests for corrections on ATF.
    3. One "special error:" Use of Non DOT CCF.
           Correction requires documentation and hoop jumping. [§40.271]
    4. If errors are not corrected, BAT or STT must "Cancel" test.
    § 40.273 WHAT IS THE EFFECT OF A CANCELED ALCOHOL TEST?
    A Canceled test is neither negative nor positive.
  • DER must be notified of cancellation within 48 hours.
  • May not be used for administrative action (hiring, firing, etc.)
  • May not require a re-test except where regs require a negative result.
  • May not be counted for quota of randoms etc.
  • Does not justify requirement for a non-DOT test.
    		•
    § 40.275 VENIAL SINS
    "No person concerned with the testing process may declare a test canceled based on an error that does not have a significant adverse effect on the right of the employee to have a fair and accurate test."
    --------------------------------------------------------------------------------------------------------------------------------------
    Even though not "fatal" these errors can get you penalized!
    Errors which are problems but insufficient to render a test "canceled."
    1. Minor clerical error such as spelling or transposition of SSN digits.
    2. An error that does not affect employee protections... 
    3. Testing by a BAT or STT who has not met training requirements (?)
       [Regs fall short here. Spells this out for Collectors but not for BAT & STT.]
    4. A delay in the testing process.
    5. Verification by an MRO who has not met training requirements.
    6. Collection in a facility which does not meet requirements of 40.223.
    7. Claims that donor was improperly selected for testing.
    § 40.277 ARE OTHER TESTS FOR ALCOHOL PERMITTED?
  • No!  DOT permits only saliva and breath testing... and...
  • Tests must always be conducted according to these rules.
    		•

     
     

    SUBSTANCE ABUSE PROFESSIONALS & RTD
    [Sub Part O]

    § 40.281 Qualifications for SAP's are completely re-defined
  • SAP's will now require both Credentials and Certification!
  • Must successfully complete "Certification exam."
  • No one may "grandfather."  All must be certified by 12/31/03.
  • Requirements now exactly parallel with those of MRO.
  • No courses or standardized tests available yet; but will come.
    		•
    § 40.281 "Automatic SAPs" are same Categories as heretofore. (National Exams)
    "Sanctioning Bodies" also the same: NAADAC & ICRC.
    New guidelines defined for becoming a "Sanctioning Body."
    § 40.285 Donors who "substituted" or "adulterated" must now have SAP evaluation.
  • This may be "difficult" since no tests for drugs are done on these specimens.
  • Requirement for SAP evaluation otherwise unchanged: "any violation."
    		•
    § 40.287 Employer must provide "violators" a List of available Certified SAP's.
  • This requirement applies even if "zero tolerance."
  • Also applies even for pre-employments.
  • Use of NAADAC or ICRC list not specifically forbidden.
    		•
    § 40.293 New rules REQUIRE the SAP to refer violator for treatment/education.
  • SAP no longer has the option of finding "no addiction problem."
  • "Self referral" is still forbidden.
  • There is no more "loop hole" for violator to return directly to duty.
  • This will require "conforming amendments" from FMCSA et. al.
    		•
    § 40.295 SAP's Evaluation and decision is final.
  • Neither employer nor employee may seek "second opinion."
  • Employer must IGNORE "second opinion" if employee obtains one.
    		•
    § 40.297 A SAP MAY amend his/her decisions and RTD requirements:
  • New information can lead to a change of SAP recommendations.
  • Only the SAP may change SAP decisions or recommendations.
  • No one else may change the decisions or RTD requirements of a SAP.
    		•
    § 40.301 Return to duty is re-defined as EMPLOYER decision!
  • SAP informs employer when employee has completed recommendations.
  • Ultimate RTD decision is up to the employer!
    		•
    § 40.309 Follow-up (relapse prevention) testing:
  • MINIMUM requirement is still 6 unannounced tests in first 12 months.
  • SAP has discretion to order more tests.
  • Follow up testing may be carried out to total of 60 months.
  • Follow up testing requirements follow the donor from job to job!
    		•
    § 40.311 New regs specify format and content of SAP report.
    These are lengthy and detailed but logical.
    § 40.329 SAP must make his reports and documentation available to employee upon request.

    THE PUBLIC INTEREST EXCLUSION (P.I.E.)

    § 40.361   to   40.413 THIS ENTIRE SECTION IS NEW !
  • Everyone should be familiar with provisions
  • No one should need to memorize... unless....
    		•
    FOLLOWING IS THE D.O.T. SLIDE SHOW ON P.I.E.'s














    © Copyright, 2001, Daniel C. Drew, M.D.  All rights reserved!
    MURPHY'S LAWS FOR DRUG TESTING
    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
    1 
  • Some donors with VERIFIED positive tests results are innocent.
  • They are very rare.  The MRO cannot identify them!
  • Only they and God know who they are.
  • They lose their jobs!
    		•
    2 
  • Drug abusers are just as smart as non users.
  • God loves drug abusers just as much as anyone else.
  • All the same, they should not be flying planes or driving trucks.
  • Drug abusers need advocacy, not criticism.
  • No one needs to be told s/he "has a problem."
    		•
    3 
  • Savvy drug abusers have prescriptions. 
  • Savvy drug abusers pick a drug we don't test for.
    		•
    4 
  • The primary purpose of a drug testing program is DETERRENCE... not detection.
  • Positive tests are a measure of detection
  • Negative tests are a measure of deterrence.
  • If there is no detection, there is no deterrence.
    		•
    5 
  • The federal drug testing program is an EMPLOYER directed program.
  • Drug testing is a government mandated extra expense to Employers.
  • Even the happiest of our customers would like it to go away.
    		•
    6 
  • COMPLIANCE is the magic word... not price, not speed, and not convenience. 
    		•
    7 
  • Employers may delegate tasks and functions but NOT responsibility.
    		•
    8 
    9 
    10 
    © Copyright, 2001, Daniel C. Drew, M.D.  All rights reserved!