US · guidance
CMS SOM App. H, Tag V599
§ 494.100(c)(2) The dialysis facility must maintain a recordkeeping system that ensures
continuity of care and patient privacy. This includes items and services furnished by
durable medical equipment (DME) suppliers referred to in § 414.330(a)(2) of this chapter.
Interpretive Guidance § 494.100(c)(2):
The facility must maintain a centralized recordkeeping system for home dialysis patients, which
includes documentation of patient assessments and plans of care, training and competency
verification, patient monitoring, and records of machine and water treatment/dialysate delivery
systems, the latter of which may be in a separate log.
Both the dialysis facility and DME supplier must have recordkeeping systems that are HIPAA-compliant and effective in assuring continuity of care. Concerns with patient privacy rules, e.g.
facility practice on who can and receive health information, identified during a Federal health
and safety survey will be referred to the Office of Civil Rights (OCR) for compliance review. The
regulations for DME suppliers at § 414.330(a)(2) require the DME supplier to report all data
for each patient regarding services and items furnished to the home patient to the supporting
ESRD facility every 45 days; thus, there should be no issue with the DME supplier providing
records within the 2 months allowed by these regulations.
Use this tag if deficient practices in the content or maintenance of home dialysis patients’
records are identified. For major issues related to the home patient records, refer to V731.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
143ecca90a074ca5f73bf0ac6f4d5eb8f443c3f695676cfa68a478917dbd7dd2
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