05 Dec Rules and Regs: Medical Recordkeeping
How long do I have to keep medical records?
Computer generated records
Federal regulations allow for the use of automated data processing systems, or other electronic or mechanized records systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are visually identified apart from other items appearing on the records (21 CFR §1304.01). Georgia State Board of Pharmacy Rules, which are binding for veterinarians, are more specific. The following is a version of Rule 480- 27.05, edited to reflect the requirements of veterinarians who use these systems:
An automated data processing system (computer and software program) may be employed for the recordkeeping system if the following conditions are met:
(a) All original written prescriptions must be retained as a permanent record for two years in the usual consecutively numbered prescription file
(b) The system shall at a minimum produce sight readable printouts for all controlled substance prescriptions for each 24 hour period. The term sight-readable means that a regulatory agent shall be able to examine the record and read the information. These printouts must be generated at least weekly and maintained for two years.
(c) Such information shall include, but not be limited to, the prescription requirements and records of dispensing controlled or dangerous (legend) drugs by other means
(d) The individual responsible for completeness and accuracy of the entries to the system, must provide documentation of the fact that the prescription information entered into the computer is correct, by dating and signing the print-out in the same manner as signing a check or legal document.
(e) An auxiliary record keeping system shall be established for the documentation of dispensing if the automated data processing system is inoperative for any reason. When the system is restored to operation the prescription information shall be entered into the system within 96 hours.
(f) Any veterinary practice using an automated data processing system must comply with all applicable state and federal laws and regulations.
(g) A veterinary practice shall make arrangements with the supplier of data processing services or materials to assure that the practice continues to have adequate and complete prescription and dispensing records if the relationship with such supplier terminates for any reason. A practice shall assure continuity in the maintenance of records.