| (19) An ESRD facility which was licensed prior to the effective date of these rules shall comply with §117.101 of this title (relating to Construction Requirements for an Existing End Stage Renal Disease Facility). An ESRD facility which is licensed after the effective date of these rules shall provide a separate training room for home dialysis patients in compliance with §117.102(d)(5) of this title. (k) If a facility dialyzes a patient who is normally dialyzed in a distant facility, the facility shall meet the requirements in this subsection. (1) The facility shall continuously evaluate staffing levels and utilize this information in determining whether to accept a transient patient for treatment. (2) The facility shall obtain the information described in §117.47(e) of this title (relating to Clinical Records) prior to providing dialysis. However, if the transient patient arrives unannounced, the facility may provide dialysis with, at a minimum, the following information: (A) evidence of evaluation of the patient by a physician on the staff of the facility; (B) orders for treatment; (C) hepatitis B status; and (D) medical justification by the physician ordering treatment that the patient's need for dialysis outweighs the need for the additional clinical information set out in §117.47(e) of this title. (3) In the event a transient patient's hepatitis status is unknown, the patient may undergo treatment as if the HBsAg test results were potentially positive, except that such a patient shall not be treated in the HBsAg isolation room, area, or machine. (l) A facility that provides laboratory services shall comply with the requirements of Federal Public Law 100 - 578, Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988 applies to all facilities that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. (m) A facility shall not violate Occupations Code, Chapter 102, concerning the prohibition on soliciting patients or patronage. (n) The facility shall comply with the Health and Safety Code, Chapter 166, concerning out-of-hospital do-not-resuscitate orders. (o) A facility or its corporate ownership, shall develop, implement, and enforce a compliance policy for monitoring its receipt and expenditure of state or federal funds. (p) If the facility has a contract or agreement with an accredited school of health care to use their facility for a portion of the students' clinical experience, those students may provide care under the following conditions. (1) Students may be used in facilities, provided the instructor gives class supervision and assumes responsibility for all student activities occurring within the facility. If the student is licensed (e.g., a licensed vocational nurse attending a registered nurse program for licensure as a registered nurse) the facility shall ensure that the administration of any medication(s) is within the student's licensed scope of practice. (2) A student may administer medications only if: (A) on assignment as a student of his or her school of health care; and (B) the instructor is on the premises and immediately supervises the administration of medication by an unlicensed student and the administration of such medication is within the instructor's licensed scope of practice. (3) Students shall not be used to fulfill the requirement for administration of medications by licensed personnel. (4) Students shall not be considered when determining staffing levels required by the facility. (q) A facility shall adopt, implement, and enforce procedures for the resolution of complaints relevant to quality of care or services rendered by licensed health care professionals and other members of the facility staff, including contract services or staff. The facility shall document the receipt and the disposition of the complaint. The investigation and documentation shall be completed within 30 calendar days after the facility receives the complaint, unless the facility has and documents reasonable cause for a delay. |
