(a) The medical director shall meet the requirements set forth in the CMS Conditions for Coverage and is responsible for:
- (1) developing facility treatment goals that are based on review of aggregate data assessed through quality assessment and performance improvement (QAPI) activities;
- (2) ensuring adequate training of licensed nurses and dialysis technicians;
- (3) adequate monitoring of patients and the dialysis process;
- (4) developing, implementing, and enforcing all policies required by this chapter;
- (5) ensuring the facility's attending physicians follow the facility's policies and procedures, and the physicians follow the facility's established treatment and clinical standards, including quality, safety, and infection control standards; and
- (6) ensuring all facility care staff, including nurses, patient care technicians, social workers, dietitians, physicians, and other ancillary staff receive annual training in all modalities, including transplant.
(b) The facility shall meet the following requirements regarding medical staff responsibilities.
- (1) Each patient shall be under the care of a licensed and qualified nephrologist on the medical staff, or a physician on the medical staff who has demonstrated experience treating dialysis patients for at least 18 months.
(2) Each pediatric dialysis patient shall be under the care of a pediatric nephrologist or under the care of an adult nephrologist with direct patient evaluation by a pediatric nephrologist as follows:
- (A) for patients two years of age or younger, monthly (two of three evaluations may be conducted by phone);
- (B) for patients 3-12 years of age, quarterly; and
- (C) for patients 13-18 years of age, semiannually.
- (3) For each patient receiving dialysis in the facility, a physician on the facility's medical staff shall see the patient at least twice a month. The physician shall conduct the first visit in person. The second visit is required unless the patient is stable, as justified in the patient record by the physician. If the second visit is necessary, it shall be separated from the first visit by at least 10 calendar days and may be conducted in person or using telemedicine. Additional visits conducted in the same month by a physician may be conducted using telemedicine.
(4) Home dialysis patients shall be seen by a physician, an advanced practice registered nurse (APRN), or a physician assistant (PA) no less than once a month.
- (A) The physician shall see the patient in person at least once every three months.
- (B) The physician shall conduct physician visits required by subparagraph (A) of this paragraph in person and may conduct the visit in the dialysis facility, at the physician's office, or in the patient's home. The physician may conduct additional visits in the same month using telemedicine.
- (C) An APRN or a PA may conduct the visits required by this paragraph using telemedicine.
- (D) The record of these contacts shall include evidence of assessment for new and recurrent problems and review of dialysis adequacy each month.
- (5) The facility shall ensure a physician on the medical staff is on call and available 24 hours a day (in person or by telecommunication) to patients and staff.
(6) The physician shall verify and sign all orders for treatment. Facility staff shall update routine orders for treatment at least annually. Any changes in patient treatment shall be per physician's order.
- (A) Orders for hemodialysis treatment shall include length of treatment, dialyzer, blood flow rate, dialysate composition, target weight, all medications administered during or needed for treatment, and specific infection control measures, as needed.
- (B) Orders for peritoneal dialysis treatment shall include fill volumes, number of exchanges, dialysate concentrations, catheter care, medications, and specific infection control measures, as needed.
(c) If the facility uses APRNs or PAs:
- (1) the facility shall ensure documented evidence of communication with the treating physician whenever the APRN or PA changes treatment orders;
- (2) the APRN or (PA) shall not replace the physician in participating in patient care planning or in QAPI activities;
- (3) the APRN or PA shall not replace the physician for the completion of assessments, as defined by the CMS Conditions for Coverage, or for the twice monthly evaluation of the in-center dialysis patient;
- (4) the APRN or PA shall notify the treating physician of patient medical emergencies;
- (5) the APRN or PA shall meet the requirements established by the Texas Board of Nursing (for an APRN) or the Texas Physician Assistant Board (for a PA); and
(6) the APRN or PA shall use mechanisms that provide authority for that care, which shall include protocols or other written authorization:
- (A) reviewed and approved by the APRN or PA and the appropriate physician;
- (B) signed by both the APRN or PA and the physician;
- (C) reviewed and re-signed at least annually;
- (D) maintained in the practice setting of the APRN or PA; and
- (E) made available as necessary to the Texas Health and Human Services Commission (HHSC) to verify authority to provide medical aspects of care.
- (d) The facility shall comply with Texas Health and Safety Code Chapter 166 (relating to Advance Directives) concerning out-of-hospital do-not-resuscitate orders.
(e) If the facility has a contract or agreement with an accredited school of health care for the school to use their facility for a portion of the students' clinical experience, those students may provide care under the following conditions.
- (1) The facility may offer clinical experience to students, provided the instructor is present at the facility, provides direct supervision to the student, and assumes responsibility for all student activities occurring within the facility.
(2) A student may administer medications only if:
- (A) on assignment as a student at their school of health care; and
- (B) under the immediate supervision of a qualified registered nurse on staff at the facility.
- (3) A facility shall not use a student to fulfill the requirement for administration of medications by licensed personnel.
- (4) A facility shall not consider a student when determining staffing levels required by the facility.
- (5) A student shall not mix concentrate or test water quality.
- (6) A student shall not accept or transcribe physician orders.
- (7) A student shall not conduct the assessments of new or unstable patients.
- (8) A qualified registered nurse shall directly supervise the students to protect the students and facility patients.
Source Note:The provisions of this §507.52 adopted to be effective December 23, 2025, 50 TexReg 8289.