Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication

gavelThe Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records.  The underlined portions below are the new standards required for medical records as it relates to compounded medications.  These standards are effective September 9, 2013.

64B8-9.003 Standards for Adequacy of Medical Records.

(1) Medical records are maintained for the following purposes:

(a) To serve as a basis for planning patient care and for continuity in the evaluation of the patient’s condition and treatment.

(b) To furnish documentary evidence of the course of the patient’s medical evaluation, treatment, and change in condition.

(c) To document communication between the practitioner responsible for the patient and any other health care professional who contributes to the patient’s care.

(d) To assist in protecting the legal interest of the patient, the hospital, and the practitioner responsible for the patient.

(2) A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.

(3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.

(4) Medical records in which compounded medications are administered to a patient in an office setting must contain, at a minimum, the following information:

(a) The name and concentration of medication administered;

(b) The lot number of the medication administered;

(c) The expiration date of the medication administered;

(d) The name of the compounding pharmacy or manufacturer;

(e) The site of administration on the patient;

(f) The amount of medication administered; and

(g) The date medication administered.

(5) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered into the record. However, office records do not need to be timed, just dated.

(6) In situations involving medical examinations, tests, procedures, or treatments requested by an employer, an insurance company, or another third party, appropriate medical records shall be maintained by the physician and shall be subject to Section 456.061, F.S. However, when such examinations, tests, procedures, or treatments are pursuant to a court order or rule or are conducted as part of an independent medical examination pursuant to Section 440.13 or 627.736(7), F.S., the record maintenance requirements of Section 456.061, F.S., and this rule do not apply. Nothing herein shall be interpreted to permit the destruction of medical records that have been made pursuant to any examination, test, procedure, or treatment except as permitted by law or rule.

Rulemaking Authority 458.309, 458.331(1)(v) FS. Law Implemented 456.061, 458.331(1) FS. History–New 1-1-92, Formerly 21M-27.003, Amended 1-12-94, Formerly 61F6-27.003, Amended 9-3-95, Formerly 59R-9.003, Amended 8-20-02. 9-11-06, 9-9-13.

One thought on “Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication

  1. Pingback: The Next Passenger on the Health Train: Physician Assistants | Florida Healthcare Law Firm Blog

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