ARM 37.106.3312. PATIENT FILES

(1) An experimental treatment center must keep a separate, secured file for each patient treated at the center. (2) The patient file must include, at a minimum: (a) patient identification, including the patient’s full name, sex, address, date of birth, and next of kin or emergency contact; (b) a full history and physical (H&P) by a treating practitioner; (i) documentation from the patient’s treating practitioner that the patient meets the criteria for experimental treatments; (ii) the recommendation from the patient’s treating practitioner for an experimental treatment; (iii) the H&P must have been completed within 30 days of the visit to the experimental treatment center; (c) relevant procedure, laboratory, and pathology reports; (d) admitting diagnosis and desired health outcomes; (i) desired health outcomes must be specific to the patient’s condition for which experimental treatment is being provided; (e) allergies or known abnormal drug reactions; (f) documentation to support that the patient evaluated other treatment options currently approved by the United States Food and Drug Administration; (g) informed consent pursuant to and in alignment with 50-12-105, MCA; (h) a copy of the patient agreement required by ARM 37.106.3311; (i) documentation and results of all tests, reports, procedures, and labs obtained at the center; (j) pre-treatment screening for contraindications, concomitant medications, and lifestyle risk factors; (k) interdisciplinary progress notes; (l) treatment plans and outcomes; and (m) discharge note, discharge diagnosis, and discharge instructions. (3) If the center performs procedures requiring anesthesia, each patient who receives anesthesia must also have in their chart: (a) anesthesia reports; (b) nurses’ notes on preoperative and recovery conditions; and (c) preoperative and postoperative orders. (4) Patient files must include the date and circumstances of discharge. Discharged patient files must be kept for a minimum of five years after the date of discharge.