UNC Health in North Carolina has developed a compliance guidebook to help its off-campus clinics understand CSA requirements and self-audit them, said Patrick Kennedy, executive system director of hospital compliance at UNC Health (see story, p. 1). Here are a few of the pages from the binder. Contact Kennedy at patrick.kennedy@unchealth.unc.edu.
Summary of record requirements
|
Record Requirements |
Forms |
Notes |
|---|---|---|
|
Every three years |
DEA license
|
Should be posted on wall. Cost: Tax exempt for UNC clinics. |
|
Biennial |
CS inventory |
After the initial inventory, registrant should take a new inventory of all controlled substance stocks on hand at least every two years. (May be taken on any date within two years of the previous biennial date.) |
|
Annual |
DHHS registration
|
Recommend to start renewal process two months in advance. Should be posted on wall. Cost: changes each year. |
|
Daily |
DEA Form 222 |
Stored in secure, locked location with limited access. |
|
Invoices of purchases
|
Must be kept by registrant and available for at least three years from date of invoice for inspection. | |
|
Invoices of sales to reverse distributors
|
Must be kept by registrant and available for at least three years from date of invoice for inspection. | |
|
Power of attorney forms
|
Must be executed by the officer of the corporation (e.g., president) who signed the most recent application for DEA registration or re-registration and expires when POA is revoked by the person who signed the most recent application. | |
|
CS inventory
|
Should be completed on the date the inventory is taken and should be maintained in written, typewritten, or printed form at the registered location. | |
|
Reporting loss or theft
|
DEA Form 106 must be completed and submitted within one business day of discovery of the theft or loss. |
Notes
-
Unless noted otherwise, all required records concerning controlled substances must be maintained for at least three years for inspection and copying by duly authorized DEA officials.
-
Inventories and records of CII medications must be stored separately from CIII-CV medications.
-
Additionally, purchase records, received invoices and restock reports should be reconciled for each order by the registrant for diversion prevention.
