CMS SOM App. H, Tag V663

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.

Interpretive Guidance § 494.120(b):

An SPRDF is to provide care that would not otherwise be available in that geographic area. In

the case of vacation camps, the “geographic locality” factor is related to minimizing the time

that the patient would be away from camp activities. There may be a dialysis facility within

driving distance, but dialysis treatment would take the camper away from the camp activities.

In the case of emergency circumstance facilities, the intent is to temporarily provide service until

permanent arrangements are possible (not to exceed the certification limitations under §

494.120(a)).

An SPRDF established to provide care to patients with medical or psychosocial needs which

cannot be met in a standard outpatient dialysis setting should define the population it intends to

serve in its admission criteria and include in those criteria the lack of outpatient dialysis service

for these patients within the geographic area.

No Tag

(Rev. )

§ 494.120(c) Standard: Scope of requirements.

(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

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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);

(iv) Patients’ rights and posting of patients’ rights § 494.70(a) and § 494.70 (c);

(v) Laboratory services at § 494.130;

(vi) Medical director responsibilities for staff education and patient care policies and

procedures at § 494.150(c) and (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).

Interpretive Guidance § 494.120(c)(1):

This is an informational tag. The sections of the regulations listed here outline the survey of a

vacation camp SPRDF. If deficient practices are identified, appropriate tags under the

referenced regulations should be used to identify deficiencies.

A vacation camp SPRDF must be affiliated with a certified outpatient dialysis facility but will

have its own unique CMS certification number (CCN).

Because the SPRDF for a vacation camp will provide service on a temporary basis, it must meet

only the specified portions of these regulations.

Note: Due to the limited scope of requirements for SPRDFs for a vacation camp, surveyors

should review the regulatory language to verify which requirements would not apply to the

special purpose facility.

No Tag

(Rev. )

§ 494.120(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 (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).

(iii) Section 494.70(a) through section 494.70(c) (patient rights).

(iv) Section 494.140 (personnel qualifications).

(v) Section 494.150 (medical director).

(vi) Section 494.180 (governance).

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Interpretive Guidance § 494.120(c)(2):

This is an informational tag. Sections of the regulations listed here are to be used to survey an

emergency circumstance SPRDF. If deficient practices are identified, the appropriate tags under

the referenced regulations should be used.

An SPRDF set up for an emergency circumstance will be issued a unique CCN. These facilities

may only provide care to those patients who would otherwise be unable to obtain treatment in

that geographic area, and are limited to an 8-month period of operation in any 12 month period.

Note: Due to the limited scope of requirements for SPRDFs for emergency circumstances,

surveyors should review the regulatory language to verify which requirements would not apply

to the special purpose facility.