California Code of Regulations
Title 22 - Social Security
Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies
Chapter 7.1 - Specialty Clinics
Article 6 - Hemodialyzer Reuse
Section 75195 - Scope and Application

Universal Citation: 22 CA Code of Regs 75195

Current through Register 2024 Notice Reg. No. 38, September 20, 2024

(a) This Article applies to all dialysis facilities which are engaged in the practice of hemodialyzer reprocessing and reuse.

(b) Deviation from any of the sections contained in this Article without an alternative reuse protocol approved by the Department constitutes a violation as referenced in Health and Safety Code, Division 21, Section 417.14.

(c) A dialysis facility may submit an alternative protocol for Department approval for any of the sections contained in this Article. Within 30 days of receipt of a request for approval of an alternative protocol, the Department shall inform the applicant, in writing, that the request is complete and accepted for consideration or that the request is deficient and what specific information is required. The Department shall approve or disapprove the request within 90 days of receipt.

(d) These regulations shall not apply to dialysate delivery systems nor new dialyzers.

1. New section filed 4-8-87; effective thirtieth day thereafter (Register 87, No. 16).

Note: Authority cited: Sections 208(a), 417.10, 1225 and 1275, Health and Safety Code. Reference: Sections 417.10- 417.15, 1226 and 1276, Health and Safety Code.

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