Legal Aspects of Health Care

Legal Aspects of Health Care

Regulation of Texas ESRD Facilities

An End Stage Renal Disease (ESRD) facility is one that "provides dialysis treatment or dialysis training to individuals" with this disease ("Licensing"). In keeping with its stated goal of ensuring the protection of public health and safety ("Philosophy"), the state of Texas requires such facilities to meet certain regulatory standards concerning design and space, equipment, water treatment and reuse, and sanitary and hygienic conditions; patient care and treatment; and dialysis technicians.

The federal government distinguishes among five types of ESRD facilities: transplant centers, dialysis centers and dialysis facilities (the distinction being that the former is a hosipital unit and the latter a stand-alone site), self-dialysis units, and special purpose renal dialysis centers (which are generally set up for emergency situations). All of these types of facilities in service after September 1, 1996 are subject to Texas licensing requirements.

The standards regarding design, space, water use, and sanitary conditions are concerned with the physical operating specifications of the facility or unit itself. Each of these standards is aimed at the general physical safety, medically-necessary cleanliness, and/or bodily or emotional comfort of patients and their families. Standards regarding equipment are concerned with both the safe operation and efficient treatment of necessary dialysis machinery (25 TAC 117.1-85). Fees for licensure are $2,000 for initial and relocation applications; a renewal fee of $.25/treatment is also assessed, with a minimum/maximum limit of $1,000/$2,500 (TDH "Licensing").