16 Del. Admin. Code § 3340-11.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3340-11.0 - Medical Records

11.1 The FSED 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.

11.2 An accurate and legible medical record must be maintained on every individual receiving care in the FSED.

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

11.4 The FSED shall ensure that each medical record is treated with confidentiality and is maintained according to professional standards of practice.

11.5 The FSED shall designate a person to be in charge of medical records. This person's responsibilities include, but are not limited to:

11.5.1 The confidentiality, security, and safe storage of medical records;

11.5.2 The timely retrieval of individual medical records upon request;

11.5.3 The specific identification of each patient's medical records;

11.5.4 The supervision of the collection, processing, maintenance, storage, retrieval, and distribution of medical records; and

11.5.5 The maintenance of a predetermined organized medical record format.

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

11.6.1 Medical 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.

11.6.2 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.

11.6.3 The FSED 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.

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

11.6.5 The FSED must establish procedures for the notification to patients regarding the pending destruction of the medical records.

11.6.6 Documentation of medical record destruction must be maintained by the FSED.

11.7 If the FSED 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.

11.8 Each time the patient visits the FSED the medical record shall contain sufficient accurate information. This information must include, but is not limited to:

11.8.1 Complete patient identification;

11.8.2 Date, time and means of arrival and transfer or discharge;

11.8.3 Allergies and untoward reactions to drugs recorded in a prominent and uniform location;

11.8.4 A complete description of any care given to the patient before the patient's arrival at the facility;

11.8.5 Pertinent history of the illness or injury and results of the physical examination, including the patient's vital signs;

11.8.6 A complete detailed description of treatment and procedures performed in the FSED;

11.8.7 Clinical observations including the results of treatments, procedures, and tests;

11.8.8 Diagnostic impressions;

11.8.9 All medication and treatment orders signed by the prescribing physician or non-physician provider;

11.8.10 All medications administered, including the drug name, dose, route of administration and time of administration;

11.8.11 All medications dispensed to the patient by the FSED, including the drug name, dose, route and frequency of administration;

11.8.12 Documentation of a properly executed informed consent when necessary;

11.8.13 For patients with a length of stay greater than eight (8) hours, an evaluation of nutritional needs and evidence of how identified needs were met;

11.8.14 Evidence of evaluation of the patient by a physician or non-physician provider prior to discharge or transfer; and

11.8.15 Conclusion at the termination of evaluation or treatment, including final disposition, the patient's condition on discharge or transfer, and any instructions given to the patient or family for follow-up care.

11.9 All entries in the medical record shall be legible, accurate, complete, dated, timed and authenticated by the person responsible for providing or evaluating the service provided no later than 48 hours after discharge.

11.10 To ensure continuity of care, summaries or photocopies of the patient's medical record shall be transferred to the facility where future care will be rendered.

11.11 The FSED shall maintain the following:

11.11.1 A log identifying each individual who presents to the FSED for treatment and services including name, date and the time of arrival.

11.11.2 Statistical information concerning admissions, transfers, discharges, deaths and adverse incidents required for the effective administration of the facility.

16 Del. Admin. Code § 3340-11.0

24 DE Reg. 692( 1/1/2021) (final)