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Top Collection Mistakes and How to Avoid Them

Presented by:

Lisa MorrisonEMBA, C-SAPA, M-CPCT, NAADATP, C-BAT, C-MROA, COSS

About this Webinar

The DOT recently informed DATIA that a number (over 400) clandestine collections took place during 2014 by various DOT modal agencies. Out of these clandestine collections, a number of errors were found to take place and large percentages were issued Notices of Non-Compliance to correct their errors. This webinar will discuss many common errors and what collection sites need to do to ensure that they are not making the same mistakes.

Objectives

• Common DOT Drug Collection Mistakes

– Correct procedures for completing the collection

– Suggestions for overcoming the obstacles

• Problem Collections

– What to look for as a collector

– Correct procedures for completing the problem collection

• Best Practices for Error-Free Testing

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Disclaimer

• This webinar is focused on the Department of Transportation’s Regulated Testing, and therefore will not address the DHHS Testing Regulations or Non-Federal testing.

CCF not LegibleERROR

• Custody and Control Forms (CCFs) received are illegible.

SOLUTION

• Collectors must review all copies of the CCF prior to distributing them to ensure that each copy is legible. Look at copy 5 (Donor Copy).

• Instruct donor to press hard when writing

• Use black ink; Do not use a felt-tip pen or marker

• Faxing to MRO and C/TPA: Collector should make a darker copy of CCF prior to faxing to ensure it will be legible when received.

Not Receiving CCF as RequiredERROR

• MROs and Employers are reporting that they are not receiving their respective copies of the CCFs despite multiple requests. Per DOT Regulations, collectors must send the CCF within 24 hours of the collection (or the next business day) and must keep their copies of CCFs for at least 30 days (readily available).

SOLUTION

• Ensure that the fax actually went through by attaching the fax transmittal report to the CCF. Just because you hit “send” does not mean it went through.

• If you fax to the same MRO or C/TPA office regularly, add them to your Auto Fax list to eliminate dialing wrong number.

• Update MRO, Collection Site, C/TPA, Etc. contact information each year to eliminate these problems. Confirm the contact information you have and the preferred submission method (fax, email, mail, etc.).

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Testing Authority not Marked on CCF

ERROR

• Collectors are not marking step 1D on the CCF to indicate which transportation mode that the collection is for: “Specify Testing Authority”– HHS NRC (DOT: FMCSA, FAA, FRA, FTA, PMHSA, or USCG)

SOLUTION

• This section is listed on the most current required Federal CCF which was mandated to be used no later than December 1, 2011. The use of older forms is no longer allowed.

• If the collector completes all sections of the CCF through STEP 5, this should eliminate any oversight of incomplete documentation.

Current Federal CCF

Donor Instructions not ProvidedERROR

• Collectors are not adequately informing donors that once the collection starts, they are prohibited from leaving the area for any reason until they have successfully completed the collection and been excused by the collector.

• Donors are not informed that leaving is considered a Refusal to Test.

SOLUTION

• DATIA recommends to instruct collectors to make a note in the remarks line that states, “Donor notified that leaving prior to completion of the collection is considered a refusal to test.”

• Post a sign in the collection area stating “If a donor leaves the testing area before completing the collection process, it will be considered a refusal to test.”

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Errors made throughout

the collection process

Donor Photo IdentificationERROR

• Collector is not asking the donor for photo identification, or not calling the DER for verification of donor § 40.61 (c)

• Or…collector is accepting the identity of the donor by the person accompanying the donor to the collection site without verifying their authority with the company.

SOLUTION

• The donor is required to provide a government, state or employer-issued PHOTO identification. If the donor does not have a photo ID, the collector should call the DER for a verbal identification.

• Make this standard practice for all drug and alcohol testing to make it routine for the collector.

• Post signs in the collection area: “Patients requiring Drug and/or Alcohol Testing must show valid photo

identification.”

Donor Photo Identification CopyERROR

• Receptionist copies donor’s photo ID for the chart and gives ID back to donor. The collector uses the photo copy to verify identification.

§ 40.61 (c) Require the employee to provide positive identification. You must see a photo ID issued by the employer (other than in the case of an owner-operator or other self-employed individual) or a Federal, state, or local government (e.g., a driver's license). You may not accept faxes or photocopies of identification……

SOLUTION

• Have receptionist attach donor’s photo ID to the patient chart or paperwork. The collector can return it to the donor after they have successfully verified their identification.

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What Service is Needed?ERROR

• Collector does not verify testing information before beginning collection (i.e., type of test, reason for test, testing authority).

EXAMPLE Donor is covered under FMCSA regulations. He is there for a post-accident test but the accident does not qualify under FMCSA testing rules. This should be a NON-DOT drug test. How would you know?

SOLUTION

• Provide your clients with an Authorization Form to complete for each visit which requests this information;

• Call the DER to clarify reason for testing prior to starting the collection process.

• Update your client profiles at least annually to ensure contact information is correct and all services are listed appropriately.

Testing Information§ 40.14 What collection information must employers provide to collectors? • As an employer, or an employer’s service agent – for example a C/TPA, you must ensure

the collector has the following information when conducting a urine specimen collection for you:

(a) Full name of the employee being tested. (b) Employee SSN or ID number. (c) Laboratory name and address (can be pre-printed on the CCF). (d) Employer name, address, phone number, and fax number (can be pre-

printed on the CCF )(e) DER information required at § 40.35 of this part. (f) MRO name, address, phone number, and fax number (can be pre-printed on

the CCF )(g) The DOT Agency which regulates the employee’s safety-sensitive duties(h) Test reason, as appropriate:(i) Whether the test is to be observed or not (see § 40.67 of this part).

(j) (Optional) C/TPA name, address, phone, and fax number (can be pre-printed on the CCF).

Donor InstructionsERROR

• Collector does not explain the collection process and/or does not show donor the back of the Donor Copy of CCF.

§ 40.61(e) Explain the basic collection procedure to the employee, including showing the employee the instructions on the back of the CCF.

SOLUTION

• Post a copy of the back of the CCF in the collection area• Give donor the instructions while waiting to be called

back for testing• Train collectors to show the back of the form when

giving the donor his/her copy of the CCF.

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InspectionERROR

• Collector is not inspecting the bathroom just prior to AND just after each collection. – Collectors are required to inspect the bathroom

before and after each collection to search for items the donor may have brought with them.

SOLUTION

When walking the donor to the bathroom and providing instructions to him/her, inspect the bathroom before handing them the container. While the donor is completing STEP 5, discard any remaining urine and inspect the bathroom again.

10 Steps to Collection Site Security

PrivacyERROR

• Others are walking in or working in the collection area while a collection is in process.

Urine Specimen Collection Guidelines:All collection sites must meet the following security requirements by having:

• 1. Procedures or restrictions to prevent unauthorized access to the site during the collection;

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Privacy Continued• 2. Procedures to prevent the employee or anyone else from

gaining unauthorized access to the collection materials/supplies. The collector must also ensure that the employee does not have access to items that could be used to adulterate or dilute the specimen (e.g., soap, disinfectants, cleaning agents, water);

• 3. Procedures to ensure that all authorized persons are under the supervision of a collector or appropriate site personnel at all times when permitted into the site.

SOLUTION

• Post signs in the facility: “Drug Collection Area. Authorized Personnel Only.”

• Establish collection site protocols for all collectors to follow

July 3, 2014

Privacy Continued

§ 40.43

(e) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored.

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Collection Site AddressERROR

• The collector performs remote collections at their client facility and uses the CCFs from the clinic that is already pre-printed with the collection site address.

§40.45 If the collection takes place on-site at the employer’s place of business (e.g., a bus terminal, a rail yard), the actual address of the employer site should be used.

• If the collection takes place in a “mobile unit” or takes place at an accident site, the collector should enter the actual location address of the collection (or as near an approximation as possible, under the circumstances).

Continued• The required collector telephone number should be the

number at which it is most likely that the laboratory, MRO, or employer, if necessary, may contact the collector and the collector’s supervisor.

SOLUTION

• Have a Remote Collection Kit with testing supplies (bluing, pens, kits, forms, etc.) and include an Instruction sheet reminding the collector that the collection site address is the location the test is being collected at (Note: phone and fax are the collector’s routine clinic numbers not the corporate office).

Monitored Collections

ERROR

• A monitored collection is required due to a multi-stalled restroom. The collector remains in the bathroom area even though the donor is an opposite gender and the collector is a non-licensed medical assistant.

§ 40.69 (b) As the collector, you must ensure that the monitor is the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician's assistant, technologist, or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector.

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Observed Collections

ERROR

• Not performing collections under direct observation when donor is being tested for Return to Duty or Follow Up

SOLUTION

• On the Authorization Form provided to your clients, pre-mark “Observed Collection” next to the Return to Duty and Follow Up Test Selections

Observed CollectionsERROR

• The donor is an opposite gender than the collector, so the clinic physician performs the observed collection even though they are not the same gender.

§ 40.67(g) As the collector, you must ensure that the observer is the same gender as the employee. You must never permit an opposite gender person to act as the observer. The observer can be a different person from the collector and need not be a qualified collector.

SOLUTION• Educate your entire staff on the observed collection

procedures so everyone is aware of the rules.

Observed Collection Procedures

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Observed Collections

ERROR

• The collector performs an observed collection following an item found that was suspected as a possible adulterant. The collector marks “Reasonable Suspicion” as the test reason even though the donor was there for a Random test.

§ 40.67(1) You must mark the “reason for test” block (Step 1) the same as for the first collection.

SOLUTION

• Ensure this is covered in your collector training

Monitored/Observed Collections

ERROR

• Collector uses another individual to conduct a monitored or observed collection but does not make note in the Remarks section.

§ 40.67(l) and § 40.69(f) As the collector, when someone else has acted as the monitor/observer you must note that person's name in the “Remarks” line of the CCF (Step 2)

SOLUTION

• Use a separate form to provide instructions to the monitor or observer explaining what they are to do and not to do during the monitor or observation, and have them print and sign their name. Transfer their name to the Remarks line of the CCF with a comment that “instructions were provided to both the donor and the observer.”

Completing Steps Before They Occur

ERROR

• Collector dates the bottle seals while still attached to the CCF. This breaks the chain of custody.

SOLUTION

• Have collector practice writing the date on the bottle seals after they are placed on the bottles to get used to the feeling.

• Have collector read the CCF step by step to ensure the chain of custody is followed.

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Completing Steps Before They Occur

ERROR

• Collector completes step 4 while donor is in the bathroom§ 40.45(4) As a collector, you may use a CCF with your name,

address, telephone number, and fax number preprinted, but under no circumstances may you sign the form before the collection event. Doing so will break the chain of custody.

SOLUTION

• Have collectors complete the CCF in the following order: Step 1, Step 2, Step 3, Step 5, Step 4

• Read the CCF Instructions• Collector Checklist

Collector Uses Initials for Their Name

ERROR

• The collector prints their name differently than how they sign, and/or they use initials for their first or last name.

• The full name of the collector must be documented and the collector must print and sign in the same manner.

SOLUTION

• Follow the instructions on the CCF (First, MI, Last)

Shy BladderERROR

• The collector marks “Insufficient amount” on the Remarks line and then when 45ml is collected, the collector completes the form.

In a shy bladder situation, the collector must document the time of the initial attempt, the amount and time that water was given and the time and outcome of each attempt after the first on the Remarks line, or a Shy Bladder form may be used and SENT WITH THE CCF TO THE LAB. Do not reference “See Shy Bladder Log” and then not send it.

SOLUTION

• Have Standard Operating Procedures so your collectors are completing the shy bladder process correctly and consistently each time.

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DOT and Non-DOT Collections

§ 40.13 How do DOT drug and alcohol tests relate to non-DOT tests?

• (a) DOT tests must be completely separate from non-DOT tests in all respects.

• (b) DOT tests must take priority and must be conducted and completed before a non-DOT test is begun. For example, you must discard any excess urine left over from a DOT test and collect a separate void for the subsequent non-DOT test.

• (c) Except as provided in paragraph (d) of this section, you must not perform any tests on DOT urine or breath specimens other than those specifically authorized by this part or DOT agency regulations. For example, you may not test a DOT urine specimen for additional drugs, and a laboratory is prohibited from making a DOT urine specimen available for a DNA test or other types of specimen identity testing.

Collector Forgets to Mark the Temperature

ERROR

• The donor forgets to mark that the temperature was within range and notices the error when faxing the MRO copy to the MRO. The donor has already left and the lab copy is sealed in the shipping bag. The collector marks the “yes” box to indicate the temperature on the MRO copy before faxing it.

Copies 2-5 must have the same information.

SOLUTION

• Instruct collectors not to complete any part of Step 2 until they have received the specimen from the donor. Then before placing the lab copy in the bag, review the form for any missing information.

Shipping Errors

ERROR

• Collector ships the specimen through their “routine” carrier/shipper, but the laboratory they collected for uses a different shipper.

SOLUTION

• Have a cheat sheet indicating how specimens are shipped for each laboratory (i.e., lab courier, call for pickup, FedEx, UPS, etc.).

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MedicationsERROR

• Collector asks donor if he/she is taking any medications and then documents information on Remarks line.

§ 40.61(g) You must instruct the employee not to list medications that he or she is currently taking on the CCF. (The employee may make notes of medications on the back of the employee copy of the form for his or her own convenience, but these notes must not be transmitted to anyone else).

SOLUTION

• Train collectors to inform the donor that if anything is detected in the urine, the Medical Review Officer will contact him/her to discuss any medications they are taking.

Collector Steps AwayERROR

• Collector walks away while donor is in the bathroom to take a phone call or to talk to other employees.

§ 40.63(e) You must pay careful attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to tamper with a specimen (e.g., substitute urine in plain view or an attempt to bring into the collection site an adulterant or urine substitute). If you detect such conduct, you must require that a collection take place immediately under direct observation (see §40.67)

SOLUTION

• Train collectors to listen outside the bathroom door for any unusual sounds and to note time the donor entered the bathroom.

Problem Collections

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Temperature Out of RangePROBLEM

• Donor provides a specimen with the temperature out of range . The collector dumps the urine and instructs the donor to drink fluids for another collection.

§ 40.65 – (5) If the specimen temperature is outside the acceptable range, you

must immediately conduct a new collection using direct observation procedures (see §40.67).

– (6) In a case where a specimen is collected under direct observation because of the temperature being out of range, you must process both the original specimen and the specimen collected using direct observation and send the two sets of specimens to the laboratory. This is true even in a case in which the original specimen has insufficient volume but the temperature is out of range. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.

Temperature Out of Range

PROBLEM

• Donor refuses to submit a second specimen following a temperature out of range and the collector sends the first specimen to the laboratory.

§ 40.65 (7) In a case where the employee refuses to provide another specimen (see §40.191(a)(3)) or refuses to provide another specimen under direct observation (see §40.191(a)(4)), you must notify the DER. As soon as you have notified the DER, you must discard any specimen the employee has provided previously during the collection procedure.

Donor Does Not Initial Bottles/Complete Step 5

PROBLEM

• Donor refuses to complete step 5 on the CCF but collector does not make note on the Remarks line.

(1) Direct the employee to read and sign the certification statement on Copy 2 (Step 5) of the CCF and provide date of birth, printed name, and day and evening contact telephone numbers. If the employee refuses to sign the CCF or to provide date of birth, printed name, or telephone numbers, you must note this in the “Remarks” line (Step 2) of the CCF, and complete the collection. If the employee refuses to fill out any information, you must, as a minimum, print the employee's name in the appropriate place.

SOLUTION

• Train collectors make notes in the Remarks Section whenever anything unusual occurs during the collection.

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Collector Does Not Complete Step 4PROBLEM

• The donor does not provide a specimen (either they leave before completing collection, or it is a shy bladder after 3 hours) and the collector did not complete STEP 3 because there was no specimen.

§40.191; §40.193 In any such case, the collector would check the box in Step 2 of the CCF indicating that no specimen was provided and enter an explanatory remark.

• The collector would then provide his or her name and signature in Step 4 of the CCF.

• The employee’s name and phone number should beincluded on the MRO copy.

SOLUTION

• Train collectors to always complete STEP 5 regardless of the outcome. This information is necessary if the MRO, Lab, or Employer has questions.

Split Collection Marked Automatically

PROBLEM

• The collector marks the “Split” box before bringing the donor back for the collection because she knows it is a DOT test and a split collection is required.

If the donor does not provide a specimen (shy bladder) then the collector would mark “none provided” on the CCF.

SOLUTION

• Instruct collectors to complete Step 2 only after they receive the urine from the donor. Use a Checklist if needed.

Change of Collectors

PROBLEM

• The donor is sitting through the shy bladder procedure and the initial collector is due to be off duty before the 3 hour time period is complete. The new collector takes over but does not document the initial collector’s information on the CCF

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Change of Collectors-Continued

§40.193; §40.43 The first collector would document the start time for the 3-hour period. The second would provide his or her name and signature after the second collection, as the collector of record. The Remarks line (Step 2 of the CCF) would be used to document the transition (including the first collector’s name and the start time for the shy bladder procedure).

SOLUTION

• Use a Shy Bladder Log indicating a second collector in the case of a change of collectors. This will remind the collectors to document the change on the CCF

Suspicious Item FoundPROBLEM

• A bottle of yellow liquid drops from the donor’s pants leg. The collector asks what it is and the donor says he really needs this job and he brought his son’s urine in to use for the test. The collector immediately conducts an observed collection.

SOLUTION

• If the donor admits to the collector that the bottle of yellow liquid was to be used to tamper with or substitute his specimen, this shall be considered a Refusal to Test.

Specimen Looks Suspicious

PROBLEM

The donor provides a specimen of 30ml that has a very pungent odor, is not of usual urine color and is not within temperature range. The collector dumps the specimen and begins shy bladder procedures.

SOLUTION

The collector should complete the collection process by securing one bottle and completing the paperwork noting the specimen was not within temperature and had suspicious odor and color. Then begin a second “observed” collection immediately referencing both CCF numbers in the remarks section of each form.

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Donor will not Empty Pockets or Remove all Items

PROBLEM

The donor will not remove his pen from his shirt pocket or his cell phone stating that he is expecting a very important call and only wants to use his pen because the collector’s pen is “dirty from handling urine.”

SOLUTION

All items must be removed from pockets and properly displayed otherwise the donor is not cooperating with the collection process.

Donor Flushes Toilet

• While this is not a violation of the collection procedures, the collector is required to instruct the donor to not flush the toilet.

• If there is suspicion as to why the donor flushed, then the collector can perform another collection under direct observation after completing the first collection. – A sign is taped over the handle of the toilet or secured

in a way that the donor would have to purposely remove it to flush the toilet.

DER Responsibilities

§ 40.11 (b)

As an employer, you are responsible for all actions of your officials, representatives, and agents (including service agents) in carrying out the requirements of the DOT agency regulations.

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Best Practices

• Know who you are providing services for.

• Know the regulations for the specific agencies.

• Develop Standard Operating Procedures

– Have a binder available with sample documentation

• Have one primary or main trainer

– Periodic audit

• Update client and vendor contact information regularly

• Hire an outside “mystery shopper”

Questions?

Lisa Morrison, EMBA

C-SAPA, M-CPCT, NAADATP, C-BAT, C-MROA, COSS

lisa@cr-plus.com

www.cr-plus.com

(419) 360-0942