16 Del. Admin. Code § 3355-11.0

Current through Register Vol. 28, No. 5, November 1, 2024
Section 3355-11.0 - Medical Records
11.1 Medical records must include an advance health-caredirective form that complies with 16 Del.C. Ch. 25, a statement that a copy of the advance health-caredirective form has been requested, or a statement that none has been signed.
11.2 The FSSC must have a documented system that enables it to systematically develop a unique medical record for each patient, permit timely access to the medical record to support the delivery of care, and store records. Records may exist in hard copy, electronic format, or a combination of the two media.
11.3 All entries in the medical record must be signed and dated by the responsible person in accordance with the FSSC's policies and procedures.
11.4 A person knowledgeable in the management of medical records shall be responsible for the proper administration and functioning of the medical records section.
11.5 There shall be an identified locked area for medical record storage at the FSSC.
11.6 Medical records shall be protected from loss, damage and unauthorized use.
11.7 The FSSC shall ensure that each medical record is treated with confidentiality and is maintained according to professional standards of practice.
11.8 The FSSC must develop acceptable policies for authentication of any computerized records.
11.9 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons; otherwise, patient records shall be held confidential. The consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations and Delaware law.
11.10 Computerized patient records must be printed by the FSSC as requested by authorized representatives of the Department.
11.11 Medical records shall be retained in a retrievable form until destroyed.
11.11.1 Records of adults (18 years of age and older) shall be retained for a minimum of five (5) years after the last date of service before being destroyed.
11.11.2 Records of minors (less than 18 years of age) shall be retained for a minimum of five (5) years after the patient reaches 18 years of age.
11.11.3 All records must be disposed of by shredding, burning or other similar protective measure in order to preserve the patient's rights of confidentiality.
11.11.4 The FSSC must establish procedures for the notification to patients regarding the pending destruction of medical records.
11.11.5 Documentation of record destruction must be maintained by the FSSC.
11.12 The FSSC must maintain compliance with all federal and state laws, regulations and guidelines governing patient privacy and medical records.

16 Del. Admin. Code § 3355-11.0

25 DE Reg. 627( 12/1/2021) (final)