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What is an Audit?

0The general definition of an audit is an evaluation of a person, organization, system, process, enterprise, project or product.

0Audits are performed to ascertain the validity and reliability of information; also to provide an assessment of a system's internal control.

0The goal of an audit is to express an opinion of the person / organization / system (etc.) in question, under evaluation based on work done on a test basis.

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Why we should appreciate audits(after you survived one…)

0 Learning Experience

0Motivator to look at processes objectively

0 Identify gaps in the program and our knowledge

0The end result is usually a better program

0 If it was a great audit – you feel really good and there may be be a reward!

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The Audit Foundation

0Documents, procedures and knowledge

0 Regulations and related publications

049 CFR Part 40

0Each modal regulation

0 Service agreements and contracts

0Contractor compliance

0 Internal company policies

0Make sure you know and understand the contents of these documents

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Audit Tools0 Know your regulations and how to apply them0 Checklists and previous guidance0 Challenge your Processes0 Maintain Consistency0 Constantly analyze your program0 Foster communication within the Company0 Build in safety nets0 Monitor your service agents and ensure you understand

what makes them compliant0 Make sure you have a strong understanding of who is and

is not covered0 Make sure your processes reflect the appropriate date

sequences for compliance

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How Audits Take Place

0 Clandestine

0 Unannounced and Unaware

0 Scheduled

0 Full Program reviews

0 Focus Audit

0Audit by association

0 Very short notice

0 Investigation

0 Sweeping Audits

0 Canvas a certain area

0 Maximize resources

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Modal Regulations

0 FAA:

0 FMCSA:

0 FRA:

0 FTA:

0PHMSA:

0USCG:

0 14 CFR Part 120

0 49 CFR Part 199

0 49 CFR Part 219

0 49 CFR Part 655

0 49 CFR Part 199

0 46 CFR Part 16 and 33 CFR Part 95

Each modality has their own criteria for education, reasons for testing, who and when someone is covered and

reporting requirements

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Help from the Regulations

0Be familiar with the ODAPC and the applicable modality web pages

0 Carefully read the inspection guides and checklist

0Review common compliance issues (FTA) has great resources

0What Employers Need to Know

0Record retention requirements

0How CCF’s are corrected

0 Previous inspection results

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Pre-Employment Activities

0When must a pre-employment test take place

0When does a pre-employment test expire

0When must a new pre-employment test be administered

0What is the appropriate time to ask 40.25(j)

0When should the Release of Information process begin and be completed by

0Are there exceptions to the requirement

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Random Testing

0What is the required annual percentage

0How often must selections be made

0When testing must occur

0What happens if a selectee is not tested

0What are alternates and how/when can they be used

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For Cause Testing

0Reasonable Suspicion

0 Initial and Recurrent training

0 How many trained supervisors are required

0 Time lengths allowed for testing

0 Post-Accident

0 Unique definition for each modality

0 Time limits for testing

0 Additional actions for post-accidents

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Positives, Refusals and Reporting

0Removal from safety-sensitive duties

0 Split specimen testing

0Who decides if there is a refusal

0Modal reporting requirements

0Recordkeeping

0Helpful documents for legal support

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49 CFR SubPart O Testing

0 Is the Company “zero tolerance” or “second chance”

0When must SAP information be given

0 Complying with the testing plan provided by the SAP

0 Complying with the directly observed requirement

0What is reported on the 40.25 documents

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Contractor Compliance

0Are your safety-sensitive contractors compliant

0How do you verify their compliance

0Are their programs registered, if required

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Policy and Education

0 Is your policy compliant and distributed to covered individuals

0Does it include who is covered, when they are covered, test reasons, prohibited conduct and the consequences

0Are covered individuals made aware of EAP resources

0DER’s are advocates for both the Company and the Emploee

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Service Agents

0Understanding the collection process

0Understanding the Breath Alcohol or Screening test process

0Understanding the service agent boundaries

0 Consortium compliance

0Medical Review Officer reporting results timely and interviewing appropriately

0 Lab reporting results timely and the semi-annual lab stats are correct

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Being Notified of an Audit

0Receive a call

0Written notification0 Will include the expected length of the audit

0DER notifies the service agents

0Respond to the auditor with any preliminary information requested, such as service agent information, etc.

0Begin reviewing your records0 Note: They should always be “audit-ready”

0 Refer to the recordkeeping handout for ideas

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Discovering a Potential Problem

0Take a deep breath

0Talk someone through the potential problem

0Re-read the regulations

0Go back and look at the process

0Make sure it is actually a problem that cannot be remedied

0 If it cannot be remedied – be honest!

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Audit Etiquette

0 Identify a suitable work location for the auditors to work

0Ensure access to the files covered by the inspection

0 Provide supplies the auditor may need

0 Information on local restaurants, take-out menus, etc.

0Where the facilities and fire escapes are located

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In-Brief

0 Company Representatives

0Auditors provide an overview

0Auditors may ask a series of questions about your records and knowledge

0 If there is something you want to disclose , this may be the time

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During the Audit

0NEVER give an answer you are unsure of. It is ok to say I will get back with you shortly”

0 If there are additional documents that are requested, you can tell them you will bring them shortly

0Make sure your Legal Department is consulted if the request may be outside of the scope of the audit

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Out-Brief

0 Company Representatives

0 The Auditors may give an initial verbal report of their findings and what the next steps might be

0 Generally, you will receive a letter in the mail addressing the audit concerns

0 The Company will be given a number of days to respond to the findings and make sufficient corrections

0 If a civil penalty will be imposed, further correspondence will likely come through the agencies Legal Department and the Company will have the opportunity to discuss the penalty

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Don’t overlook the little things….

0 Is the time on the alcohol machine correct and/or the clock on the wall?

0 Is the gas expired?0 Is the evidence tape truly tamper-proof?0 Do you have the QAP and do you know what it says?0 Can the auditor stand on the toilet and lift the ceiling tiles

while items fall down?0 Are you keeping the files locked and specimens secured?0 Is the filing cabinet locked but the key is on top of the

cabinet?0 Are the addresses correct on the CCFs?0 Do you have the EAP information displayed?

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Keys to Audit Success

0Take the audit seriously

0Have strong policies and procedures that are routinely adhered to

0Embrace periodic self audits

0Have a peer audit your program

0Know the regulations that apply

0Network with industry counterparts, sharing ideas and experience

0Remain engaged with your service agents , hold them in compliance and thank them for what they do