REBUS Consulting

• Agency Name

• Location
  Address

• Conducted on

  Date

• Prepared by

  Select Joseph Santiago MBA, MS, RN, CMTE, CHC, CACO Eric Hanchett Russ Coonradt

  • Joseph Santiago MBA, MS, RN, CMTE, CHC, CACO
  • Eric Hanchett
  • Russ Coonradt

• Please list the name(s) of agency personnel that participated in this audit

Registration (Section 1301.11) and (Section 1307.02)

• Does the State of operation require a separate Controlled Substances Authority registration?

  Yes

  No

• What is the name of the State Controlled Substances Authority having jurisdiction?

• Verify the certificate is within the expiration date

  Yes

  No

• Verify the address listed on the certificate is the actual physical address where controlled substances are stored/dispensed

  Yes

  No

• Verify the certificate accurately lists the agency business name

  Yes

  No

• Verify the certificate is conspicuously displayed

  Yes

  No

• Please upload an image of the State Controlled Substances Authority registration

  Media

• Please include any pertinent notes for this section

• Does the agency possess a DEA Registration Certificate?

  Yes

  No

• Is the State of operation considered an MLP State with the DEA?

  Yes

  No

• Is the DEA Registration filed as an MLP - Ambulance Service?

  Yes

  No

• Is the MLP Registration filed as required by the DEA "Mid-Level Practitioners Authorization by State" guidance?

  Yes

  No

• Are the appropriate schedules listed on the DEA Registration?

  Yes

  No

• Verify the certificate is within the expiration date

  Yes

  No

• Verify the address listed on the certificate is the actual physical address where controlled substances are stored/dispensed

  Yes

  No

• Verify the certificate accurately lists the agency business name

  Yes

  No

• Verify the certificate is conspicuously displayed

  Yes

  No

• Please upload an image of the DEA Registration Certificate

  Media

• Is the DEA Registration filed as a practitioner registration?

  Yes

  No

• Are the appropriate schedules listed on the DEA Registration?

  Yes

  No

• Verify the certificate is within the expiration date

  Yes

  No

• Verify the address listed on the certificate is the actual physical address where controlled substances are stored/dispensed

  Yes

  No

• Verify the certificate accurately lists the agency business name

  Yes

  No

• Verify the certificate is conspicuously displayed

  Yes

  No

• Please upload an image of the DEA Registration Certificate

  Media

Security Requirements (Section 1301.75)

• Verify the CS are stored in a securely locked, substantially constructed cabinet

  Yes

  No

• Describe provider access into secured storage

• Upload an image of where controlled substances are stored

  Media

Power of Attorney (POA) (Section 1305.05)

• Does the agency utilize a Power of Attorney with a DEA Registrant?

  Yes

  No

• Verify the POA identifies the name of the DEA Registrant (Medical Director if a Practitioner Registration)

  Yes

  No

• Verify the POA is present and within the stated expiration date (if specified)

  Yes

  No

  N/A

• Verify the POA identifies the address of the DEA Registrant (Medical Director)

  Yes

  No

• Verify the POA contains the DEA Registration Number of the Medical Director

  Yes

  No

• Verify the POA identifies the attorney-in-fact (agency employee who is authorized to act on DEA Registrant's behalf)

  Yes

  No

• Verify signatures are present for the Medical Director, Agency employee who orders CS, Witness 1, and Witness 2

  Yes

  No

• If the POA is less than 2 years old, verify and account for any previous POA

  Yes

  No

  N/A

• Please upload an image of the Power of Attorney

  Media

• Verify all orders for CS are signed by the Medical Director (If a practitioner registration), or signed by Agency representative listed on the MLP - Ambulance Service DEA Registration if not utilizing POA

  Yes

  No

Records and Reports (Section 1304.04)

• Initial inventory is present and complete if business operations at the registered location are less than 2 years old

  Yes

  No

  N/A

• Biennial inventory has been conducted every 2 years from the initial inventory date

  Yes

  No

  N/A

• All inventory records are dated, time-stamped and initialed. Including daily and biennial records.

  Yes

  No

  N/A

• All records are maintained on-site for a minimum of 2 years unless Centralized Recordkeeping has been authorized by the DEA

  Yes

  No

  N/A

• All DEA Form 222 Executed and Unexecuted or the electronic equivalent are accounted for and available for inspection

  Yes

  No

  N/A

• Inventories and records of schedule II CS are maintained separately from all other records

  Yes

  No

  N/A

• Receipts and/or invoices for schedules III, IV, and V. Ensure all records are dated, time-stamped, and initialed.

  Yes

  No

  N/A

Completed DEA and State (if applicable) Reporting Forms

• Inspection of all DEA Form 222 (executed); ensure finalized

  Pass

  Fail

  N/A

• Review of all completed DEA Form 41; ensure completeness

  Pass

  Fail

  N/A

• Review of all completed DEA Form 106; ensure completeness

  Pass

  Fail

  N/A

Disposal of Controlled Substances (Section 1317)

• Review records of disposal of expired or unwanted controlled substances in accordance with 1317.05

  Yes

  No

  N/A

Standard Operating Procedures

• Background Checks of employees who may have access to controlled substances

  Policy Present

  Policy not Present

• CS Registration (Federal and State); initial and renewal requirements

  Policy Present

  Policy not Present

• CS Security and Storage; detailed requirements

  Policy Present

  Policy not Present

• CS Recordkeeping; detailed requirements

  Policy Present

  Policy not Present

• CS Ordering; process to be followed

  Policy Present

  Policy not Present

• CS Receiving; process to be followed

  Policy Present

  Policy not Present

• CS Inventory; daily and biennial

  Policy Present

  Policy not Present

• CS Use on patients; administration and waste recordkeeping requirements

  Policy Present

  Policy not Present

• CS Removal from inventory; reasons and process to be followed

  Policy Present

  Policy not Present

• CS Reporting; State and Federal reporting requirements

  Policy Present

  Policy not Present

• CS Audit Procedures; process to be followed when served with regulatory audit request

  Policy Present

  Policy not Present

• List of Employees with CS Access; current list must be provided

  Compliant

  Non-Compliant

• Access Control (Keys, FOB, PIN) Issue and Accountability; process to be followed

  Policy Present

  Policy not Present

Business Records

• Description of Business Activity; included in the audit packet

  Present

  Not Present

• List of Corporate Officers; included in the audit packet

  Present

  Not Present

• List of CS Program Managers with their date of birth; included in the audit packet

  Present

  Not Present

Reconciliation of Records

• Compare an executed DEA Form 222 to added CS into inventory; ensure all records match and are finalized (packing slip, 222, inventory records)

  Pass

  Fail

  N/A

• Compare a clinical administration of CS to a medical record on file; ensure records match (dose and waste. Record PCR number in notes)

  Pass

  Fail

  N/A

• Compare the removal of CS from inventory for breakage/spillage/loss; ensure records match (DEA Form 41, 106, State reporting)

  Pass

  Fail

  N/A

• Compare the removal of CS from inventory for outdate/expiration; ensure records match (DEA Form 41 if destroyed on-site, Reverse distribution records if applicable)

  Pass

  Fail

  N/A

Computation Exam

• Upload a copy of the completed computation chart for this agency

  Media

Auditor Comments

• Please summarize your audit

• Auditor Signature

  Sign