16 Del. Admin. Code § 3365-7.0

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

Section 3365-7.0 - Clinical Record

7.1 A clinical record shall be maintained for every patient and newborn admitted to and cared for in the facility.

7.2 A person knowledgeable in the management of clinical records shall be responsible for the proper administration and functioning of the clinical records section.

7.3 There shall be an identified locked area for clinical record storage at the facility.

7.4 Clinical records shall be protected from loss, damage and unauthorized use.

7.5 The facility shall ensure that each clinical record is treated with confidentiality and is maintained according to professional standards of practice.

7.6 The clinical records shall contain sufficient accurate documentation of significant clinical information pertaining to the patient and newborn to justify the diagnosis and warrant the treatment and end results including but not limited to:

7.6.1 Complete patient identification including a unique identification number;

7.6.2 Admission date and time;

7.6.3 Discharge date and time;

7.6.4 Admission diagnosis;

7.6.5 Medical history;

7.6.6 Physical examination completed prior to the birth;

7.6.7 Labor and delivery record;

7.6.8 Diagnostic tests, laboratory and x-ray reports when appropriate;

7.6.9 Progress notes;

7.6.10 Properly executed informed consent;

7.6.11 Record of anesthesia, analgesia and medications administered during the course of labor, delivery and postpartum;

7.6.12 Condition upon discharge;

7.6.13 Final diagnosis;

7.6.14 Instructions for follow-up care of the patient and newborn;

7.6.15 Prenatal care record including at least:

7.6.15.1 Hemoglobin/Hematocrit;

7.6.15.2 Urine screening;

7.6.15.3 Prenatal blood serology;

7.6.15.4 RH factor determination;

7.6.15.5 Rubella titre; and

7.6.15.6 Prenatal instructions.

7.7 Newborn clinical records shall be maintained separately and shall include:

7.7.1 Date and hour of birth;

7.7.2 Birth weight;

7.7.3 Birth length;

7.7.4 Period of gestation;

7.7.5 Sex;

7.7.6 Condition of newborn on delivery, including APGAR rating and any resuscitative measures taken;

7.7.7 Mother's name and unique identification number;

7.7.8 Record of:

7.7.8.1 Ophthalmic prophylaxis;

7.7.8.2 Administration of RH immune globulin as appropriate;

7.7.8.3 Genetic screening; and

7.7.8.4 Fetal monitoring.

7.7.9 Birth and discharge physical examination;

7.7.10 Copy of birth certificate; and

7.7.11 Instructions for follow-up care.

7.8 All entries in the clinical record must be signed and dated by the responsible person in accordance with the facility's policies and procedures.

7.9 Computerized clinical records must be printed by the facility as requested by authorized representatives of the Department.

7.10 The facility records shall be retained in a retrievable form until destroyed.

7.10.1 Records of adults (18 years of age and older) shall be retained for a minimum of six (6) years after the last date of service before being destroyed.

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

7.10.3 The facility must establish procedures for the notification to patients regarding the pending destruction of clinical records.

7.10.4 All records must be disposed of by shredding, burning, or other similar protective measure in order to preserve the patients' rights of confidentiality.

7.10.5 Documentation of record destruction must be maintained by the facility.

7.11 The facility must develop acceptable policies for authentication of any computerized records.

16 Del. Admin. Code § 3365-7.0

12 DE Reg. 235 (08/01/08)
25 DE Reg. 777( 2/1/2022) (Final)