333-700-0090 Medical Records (1) The facility shall maintain complete medical records on all patients (including self-dialysis patients within the self-dialysis unit and home dialysis patients whose care is under the supervision of the facility) in accordance with accepted professional standards and practices. (2) The medical records must be completely and accurately documented, readily available, and systematically organized to facilitate the compilation and retrieval of information. Each patient's medical record shall contain sufficient information to identify the patient clearly, to justify the diagnosis and treatment, and to document the results accurately. All medical records shall contain documented evidence of the following: (a) Assessment of the needs of the patient; (b) Evidence that the patient was informed of the results of the assessment; (c) Documentation of any treatment with a reprocessed hemodialyzer (when applicable); (d) Establishment of an appropriate plan of treatment; (e) The care and services provided; (f) Identification and social data; (g) Signed consent forms: (A) All consent forms shall document that the information was provided in such a way that acknowledges the patient's individual language and special needs; and (B) Except as provided in ORS 433.045, a minor 15 years of age or older may consent to hospital care, medical or surgical diagnosis or treatment by a physician, and dental care, without the consent of a parent or guardian. (h) Documentation of an initial history and physical and an update of the history and physical at least annually or whenever changes occur; (i) Reports of any pertinent medical, surgical or access procedures which shall be filed in the record within 30 days of the procedure; (j) Referral information with authentication of diagnosis; (k) Diagnostic and therapeutic orders. Physician orders must be reviewed and rewritten annually. "Resume previous orders" is not adequate to meet the annual requirement. All verbal orders shall be received by a licensed nurse or physician associate. Orders relating to social work or nutrition services may be received by the professional responsible for that service. Verbal orders must be countersigned within 45 calendar days by the practitioner giving the order. All patients shall have written orders for length of dialysis treatment, the dialyzer type, the composition of the dialysate, the estimated dry weight, any medications the patient receives at the dialysis facility, the heparinization schedule including the amount of the bolus, maintenance dose and when to discontinue the maintenance dose, and any necessary infection control measures. New orders that include, but are not limited to the above listed items, must be written when a patient returns from an inpatient stay at a hospital; (l) Progress notes; (m) Reports of treatments and clinical findings; (n) Reports of laboratory results, diagnostic tests, and procedures; (o) Social worker and nutritional assessments: Initial assessments must be completed within 30 days of admission to the facility. Subsequent assessments must be completed annually and updated as necessary; and (p) A medication list that is updated as needed and reviewed at least quarterly or as changes occur. (3) The facility shall require and the medical director shall ensure that any adverse medical patient outcomes are communicated to the patient's physician, and that the facility takes appropriate corrective action. (4) All entries in the medical record shall be dated and authenticated by the person making the entry. (5) Protection of medical record information: There must be a plan for the retention, storage, preservation of confidentiality, certification of validity, and where appropriate, destruction of medical records. (a) The facility must safeguard medical record information against loss, destruction, or unauthorized use. The facility must have written policies and procedures which govern the use and release of information contained in medical records. (b) Written consent of the patient, or authorized person(s) acting on behalf of the patient, is required for release of information not mandated by federal law or by statute. Medical records are made available under stipulations of confidentiality for inspection by Division staff as required for administration of the dialysis program or authorized agents of the state for the purposes of confirming compliance with these rules. (c) If a patient is under the age of 15, the patient's medical records may be released only with the voluntary and informed consent of the patient's parent or legal guardian. In the case of divorce, unless otherwise ordered by the court, either parent may consent for the minor as provided by ORS 107.154. (6) Medical records supervisor. A member of the facility's staff shall be designated to serve as supervisor of medical records services, and ensure that all records are properly documented, completed, and preserved. When necessary, consultation is secured from a qualified medical record practitioner. The functions of the medical records supervisor include, but are not limited to, the following: (a) Ensuring that the records are documented, completed, and maintained in accordance with accepted professional standards and practices; (b) Safeguarding the confidentiality of the records in accordance with established policy and legal requirements; and (c) Ensuring that the records contain pertinent medical information and are filed for easy retrieval. (7) Completion of medical records and centralization of clinical information: Medical records shall be completed by all members of the dialysis facility staff within 30 days following the patient's discharge. Current medical records and those of discharged patients shall be completed promptly. All clinical information pertaining to a patient must be centralized in the patient's medical record. Provisions shall be made for collecting and including in the medical record medical information generated regarding self-dialysis patients. Entries concerning the daily dialysis process must either be completed by staff, or be completed by trained self-dialysis patients, trained home dialysis patients or trained assistants and must be countersigned by staff of the dialysis facility. (8) Retention and preservation of records: All medical records shall be kept for a period of at least seven years after the date of discharge. Original medical records may be retained on paper, microfilm, electronic, or other media. The medical records of pediatric patients shall be kept at least three years after the age of 18 or for a total of seven years, whichever is longer. (9) Location and facilities: The facility shall maintain adequate facilities, equipment, and space conveniently located to provide efficient processing of medical records (e.g., reviewing, filing, and prompt retrieval) and statistical medical information (e.g., required abstracts, reports, etc.). (10) Transfer of medical information: The facility must provide for the exchange of medical and other information necessary or useful in the care and treatment of patients transferred to other medical facilities. (11) If the facility closes or is purchased, arrangements shall be made for the medical records to be transferred to the patients' new place of treatment. In the case of expired or no longer treated patients, arrangements must be made to store those records for the required time intervals. The patients' families and the Division shall be notified of the location of the medical records. (12) Technical logs must meet the same documentation standards as the medical records, including proper correction of errors. A signature list must be readily available to identify the users of initials. Statutory/Other Authority: ORS 441.015 & 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 61-2024, minor correction filed 06/06/2024, effective 06/06/2024 PH 38-2023, minor correction filed 09/08/2023, effective 09/08/2023 PH 4-2012, f. 3-30-12, cert. ef. 4-1-12 PH 7-2003, f. & cert. ef. 6-6-03