16 Del. Admin. Code § 3330-14.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3330-14.0 - Medical Records

14.1 The dialysis center shall develop and maintain a system for the collection, processing, maintenance, storage, retrieval, authentication and distribution of patient medical records. Records may exist in hard copy, electronic format, or a combination of the two media.

14.1.1 There shall be an identified locked area for medical record storage at the dialysis center.

14.2 A complete, accurate, legible and accessible medical record must be maintained on every individual receiving care in the dialysis center.

14.2.1 Each medical record shall include, but is not limited to the following:

14.2.1.1 Identifying information;

14.2.1.2 Consents;

14.2.1.3 Medical and surgical history;

14.2.1.4 Record of the creation and revision of the dialysis access;

14.2.1.5 A comprehensive history and physical examination completed within thirty (30) days of the patient's admission to the dialysis center, and no less than annually thereafter;

14.2.1.5.1 For a patient new to dialysis, the physician is responsible to complete the comprehensive history and physical examination.

14.2.1.5.1.1 Prior to the first treatment in the dialysis center, the physician shall inform the registered nurse functioning in the charge role of at least the patient's diagnoses, medications, hepatitis status, allergies, and dialysis treatment prescription.

14.2.1.5.2 For established dialysis patients, the physician or non-physician practitioners may complete the comprehensive history and physical examination.

14.2.1.6 Physician orders, including dialysis treatment orders;

14.2.1.7 Progress notes regarding the condition and care of the patient;

14.2.1.8 Medication administration records (this can be documented on the treatment sheets);

14.2.1.9 A list of medications, including those the patient takes at home, and allergies;

14.2.1.10 Transfusion records;

14.2.1.11 Laboratory and diagnostic study reports;

14.2.1.12 Evidence of patient education;

14.2.1.13 Dialysis treatment records;

14.2.1.14 Patient assessments;

14.2.1.15 Patient plans of care;

14.2.1.16 Documentation regarding the patient's advance directive status;

14.2.1.17 Hospitalization reports; and

14.2.1.18 A discharge summary (if applicable).

14.2.2 Home dialysis patient medical records must include:

14.2.2.1 Treatment records maintained by the patient, retrieved and reviewed for adherence to the treatment prescription every two (2) months;

14.2.2.1.1 If the home dialysis patient is a resident of a long term care facility, the treatment records must indicate the name of the long term care facility staff member that provided home dialysis services.

14.2.2.2 Documentation of home dialysis training and adequate comprehension of the training;

14.2.2.3 The provision of home dialysis support services (i.e. dialysis supplies and durable medical equipment); and

14.2.2.4 Periodic home visits and monitoring of the patient's home adaption.

14.2.3 All entries in the medical record shall be dated, timed and authenticated by the responsible person in accordance with the dialysis center's policies and procedures.

14.2.4 Signature stamps may not be used to authenticate medical record entries.

14.3 Medical records shall be protected from loss, tampering, alteration, improper destruction, and unauthorized or inadvertent use.

14.3.1 The dialysis center must:

14.3.1.1 Maintain compliance with all federal and state laws, regulations and guidelines governing patient privacy and medical records;

14.3.1.2 Ensure that each medical record is treated with confidentiality and is maintained according to professional standards of practice; and

14.3.1.3 Obtain written permission from the patient or the patient's legal representative before releasing information that is not authorized by law.

14.3.2 Medical records shall be retained in a retrievable form until destroyed.

14.3.2.1 Medical records of adults (18 years of age and older) shall be retained for a minimum of six (6) years after the patient's discharge, transfer or death before being destroyed.

14.3.2.2 Records of minors (less than 18 years of age) shall be retained for a minimum of six (6) years after the patient reached 18 years of age.

14.3.2.3 The dialysis center shall not destroy medical records that relate to any matter that is involved in litigation if the facility knows the litigation has not been fully resolved.

14.3.2.4 All records must be disposed of by shredding, burning or other similar protective measure in order to preserve the patient's right to confidentiality.

14.3.2.5 The dialysis center must establish procedures for the notification to patients regarding the pending destruction of the medical records.

14.3.2.6 Documentation of medical record destruction must be maintained by the dialysis center.

14.4 When a dialysis patient is transferred to another dialysis center, the dialysis center releasing the patient must send all medical record information to the receiving facility within one (1) working day of the transfer.

14.5 Prior to providing dialysis treatment to a transient patient, a dialysis center shall obtain:

14.5.1 Orders for dialysis treatment;

14.5.2 A list of medications and allergies;

14.5.3 Reports of laboratory work, including screening for hepatitis B status, that was performed no more than one (1) month prior to treatment at the dialysis center;

14.5.4 The most current plan of care; and

14.5.5 The most current treatment records from the referring facility.

14.6 If the dialysis center plans to close, the facility shall notify the Department in writing at the time of closure of the disposition of the medical records, including where the medical records will be stored, and the name, address, and phone number of the custodian of the records.

14.7 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons.

14.8 Computerized patient records must be printed by the dialysis center as requested by authorized representatives of the Department.

16 Del. Admin. Code § 3330-14.0

22 DE Reg. 853( 4/1/2019) (final)