42 CFR 494.120 - Condition: Special purpose renal dialysis facilities.
A special purpose renal dialysis facility is approved to furnish dialysis on a short-term basis at special locations. Special purpose dialysis facilities are divided into two categories: vacation camps (locations that serve ESRD patients while the patients are in a temporary residence) and facilities established to serve ESRD patients under emergency circumstances.
(a) Standard: Approval period. The period of approval for a special purpose renal dialysis facility may not exceed 8 months in any 12-month period.
(b) Standard: Service limitation. Special purpose renal dialysis facilities are limited to areas in which there are limited dialysis resources or access-to-care problems due to an emergency circumstance. A special purpose renal dialysis facility may provide services only to those patients who would otherwise be unable to obtain treatments in the geographic locality served by the facility.
(1) Scope of requirements for a vacation camp. A vacation camp that provides dialysis services must be operated under the direction of a certified renal dialysis facility that assumes full responsibility for the care provided to patients. A special purpose renal dialysis facility established as a vacation camp must comply with the following conditions for coverage—
(i) Infection control at § 494.30;
(ii) Water and dialysate quality at § 494.40 (except as provided in paragraph (c)(1)(viii) of this section);
(iii) Reuse of hemodialyzers at § 494.50 (if reuse is performed);
(v) Laboratory services at § 494.130;
(vi) Medical director responsibilities for staff education and patient care policies and procedures at § 494.150(c) and § 494.150(d);
(vii) Medical records at § 494.170; and
(viii) When portable home water treatment systems are used in place of a central water treatment system, the facility may adhere to § 494.100(c)(1)(v) (home monitoring of water quality), in place of § 494.40 (water quality).
(2) Scope of requirements for an emergency circumstance facility. A special purpose renal dialysis facility set up due to emergency circumstances may provide services only to those patients who would otherwise be unable to obtain treatments in the geographic areas served by the facility. These types of special purpose dialysis facilities must comply with paragraph (c)(1) of this section and addition to complying with the following conditions:
(i) Section 494.20 (compliance with Federal, State, and local laws and regulations).
(ii) Section 494.60 (physical environment).
(iv) Section 494.140 (personnel qualifications).
(v) Section 494.150 (medical director).
(vi) Section 494.180 (governance).
(d) Standard: Physician contact. The facility must contact the patient's physician, if possible, prior to initiating dialysis in the special purpose renal dialysis facility, to discuss the patient's current condition to assure care provided in the special purpose renal dialysis facility is consistent with the patient plan of care (described in § 494.90).
Title 42 published on 2014-10-01
no entries appear in the Federal Register after this date.