(a)
- (1) A medical record shall be maintained for each patient of the in vitro fertilization facility.
- (2) All these records must be kept separate from the other regular records of the facility.
- (3) The original or a copy of the original (when the original is not available) of all reports shall be filed in the medical record.
(4) The record shall be:
- (A) Permanent; and
- (B) Either typewritten or legibly written in ink.
- (5) All dictated reports shall include the date of dictation and the date of transcription.
(6)
- (A) Only standard abbreviations, approved by the staff of the facility, shall be used.
- (B) This list of abbreviations shall be:
(i) Reviewed annually; and
- (ii) Revised if necessary.
(b) Medical orders. All medical orders (medication, treatments, tests, and procedures) shall be in writing and shall be signed by the physician.
- (c) Confidentiality.
- (1) Medical records shall be considered confidential.
- (2) Only authorized personnel shall have access to the medical records.
(3)
- (A) All medical records shall be secured at all times.
- (B) If authorized personnel are not present, the records shall be locked.
(4) Records shall be available to authorized personnel from the Department of Health.
- (d) Consent for procedures. A specific consent for procedures shall:
- (1) Be documented prior to the procedure to be performed; and
(2) Include the:
- (A) Date;
- (B) Time; and
(C) Signatures of:
- (i) The patient;
- (ii) The physician; and
- (iii) A witness.
- (e) A history and physical examination shall be documented prior to the procedure.
(f) Anesthesia. When anesthesia is utilized, with or without loss of consciousness, a complete anesthesia report, including pre-evaluation and post-follow-up shall be documented by the:
- (1) Anesthesiologist and/or the certified registered nurse anesthesiologist (CRNA); or
- (2) Physician who administered the anesthesia.
(g) Procedure report.
(1) An individualized procedure report shall be:
- (A) Written or dictated by the physician immediately following the procedure; and
- (B) Signed within seventy-two (72) hours.
(2) The report shall describe, in detail:
- (A) Techniques;
- (B) Findings;
- (C) Pre-procedural and post-procedural diagnosis; and
- (D) Other pertinent information.
(h) The record of the patient shall also include:
- (1) Orders and reports of diagnostic services;
- (2) Documentation of any medication administered; and
- (3) Progress notes for subsequent clinic visits recorded by applicable disciplines.