16 Del. Admin. Code § 3330-13.0

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

Section 3330-13.0 - Home Dialysis Service

13.1 A dialysis center that provides home dialysis training and support must be approved to provide home dialysis services, and ensure through its interdisciplinary team that home dialysis services are at least equivalent to those services provided to in-center patients.

13.2 The interdisciplinary team must oversee the training of the home dialysis patient, the designated caregiver(s), or self-dialysis patient before the initiation of home dialysis or self-dialysis and when the home dialysis caregiver(s) or modality changes.

13.3 The home dialysis training program must:

13.3.1 Be provided by a dialysis center that is licensed to provide home dialysis services;

13.3.2 Be approved by the medical director;

13.3.3 Be conducted by a registered nurse who meets the requirements set forth in subsection 5.11.6.1;

13.3.4 Be conducted for each home dialysis patient and at a minimum address the specific needs of the patient in the following areas:

13.3.4.1 The nature and management of ESRD;

13.3.4.2 The full range of techniques associated with the treatment modality selected, including:

13.3.4.2.1 Effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription; and

13.3.4.2.2 Safe storage and administration of erythropoiesis-stimulating agent(s) (if applicable) to achieve and maintain the target level hemoglobin and/or hematocrit as written in the patient's plan of care.

13.3.4.3 How to detect, report, and manage potential dialysis complications, including water treatment problems;

13.3.4.4 Availability of support resources and how to access and use those resources;

13.3.4.5 How to self-monitor health status and document and report health status information;

13.3.4.6 How to handle medical and non-medical emergencies;

13.3.4.7 Infection control and prevention precautions; and

13.3.4.8 Proper waste storage and disposal.

13.4 Home dialysis monitoring

13.4.1 The dialysis center must:

13.4.1.1 Document in the medical record that the patient, patient's caregiver(s) or both received and demonstrated adequate comprehension of the training;

13.4.1.2 Retrieve and review complete self-monitoring data from home dialysis patients, or their designated caregiver(s) at least every two (2) months;

13.4.1.3 Maintain documentation and self-monitoring data in the patient's medical record; and

13.4.1.4 If the patient or designated caregiver has not provided appropriate self-monitoring data at least every two (2) months, dialysis center staff must make and document all reasonable efforts to obtain these records (if applicable).

13.5 A dialysis center that provides home dialysis training and support must furnish home dialysis support services regardless of whether dialysis supplies are provided by the dialysis center or a durable medical equipment company.

13.5.1 Support services must include, but are not limited to:

13.5.1.1 Periodic monitoring of the patient's home adaptation, including visits to the patient's home in accordance with the plan of care;

13.5.1.1.1 A home visit must be conducted at the initiation of home dialysis, annually and whenever a health or treatment problem is identified that could be related to the home dialysis.

13.5.1.2 Coordination of the home dialysis patient's care by a designated member of the interdisciplinary team;

13.5.1.3 Patient consultation with members of the interdisciplinary team as needed;

13.5.1.4 Monitoring of the home hemodialysis patient's water quality and dialysate, including:

13.5.1.4.1 Conducting an onsite evaluation; and

13.5.1.4.2 Testing the water and dialysate:

13.5.1.4.2.1 Prior to the initiation of home dialysis;

13.5.1.4.2.2 In accordance with the manufacturer's instructions; and

13.5.1.4.3 Correcting any water and/or dialysate quality issues, and if necessary, arrange for backup dialysis until the issues are resolved if:

13.5.1.4.3.1 Analysis of water and/or dialysate indicates contamination; or

13.5.1.4.3.2 The home dialysis patient demonstrates clinical symptoms associated with contaminated water and dialysate.

13.5.1.5 Purchasing, leasing, renting, delivering, installing, repairing and maintaining medically necessary home dialysis supplies and equipment;

13.5.1.6 Identifying a plan and arranging for emergency back-up dialysis when necessary.

13.6 Coordination of Services when providing home dialysis in a long term care facility:

13.6.1 Prior to providing home dialysis in a long term care facility, the dialysis center and long term care facility must have a written coordination agreement that outlines clear lines of responsibility and accountability.

13.6.1.1 There must be a written coordination agreement with each long term care facility in which home dialysis patients reside.

13.6.1.2 Each written coordination agreement shall be reviewed and updated at least annually.

13.6.2 The dialysis center is primarily responsible for the quality and safety of the dialysis treatments, including:

13.6.2.1 Training of the patient and each long term care facility staff member that provides home dialysis services;

13.6.2.2 Monitoring of the patient and the home dialysis environment;

13.6.2.3 Availability of social work and nutritional consultation;

13.6.2.4 Assuring continuity of care;

13.6.2.5 Installing and maintaining home dialysis equipment;

13.6.2.5.1 There must be one machine used exclusively for each individual patient's home dialysis treatments. The same dialysis machine must not be used for multiple home dialysis patients.

13.6.2.6 Testing and treating of water; and

13.6.2.7 Ordering dialysis-related supplies.

13.6.3 The dialysis center must maintain documentation that each long term care facility staff member has received, and demonstrated adequate comprehension, of the training specific to each patient that he/she will be providing home dialysis services.

16 Del. Admin. Code § 3330-13.0

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