333-700-0060 Surveys (1) The Division shall, in addition to any investigations conducted under OAR 333-700-0057, conduct at least one on-site licensing survey of each outpatient renal dialysis facility every three years to determine compliance with health care facility licensing laws and at such other times as the Division deems necessary. (2) In lieu of an on-site inspection required under section (1) of this rule, the Division may accept: (a) CMS certification by a federal agency or an approved accrediting organization; or (b) A survey conducted within the previous three years by an accrediting organization approved by the Division, if: (A) The certification or accreditation is recognized by the Division as addressing the standards and conditions for coverage requirements of the CMS and other standards set by the Division. Health care facilities must provide the Division with the letter from CMS indicating its deemed status; (B) The health care facility notifies the Division to participate in any exit interview conducted by the federal agency or accrediting body; and (C) The health care facility provides copies of all documentation concerning the certification or accreditation requested by the Division. (3) An outpatient renal dialysis facility shall permit Division staff access to the facility during a survey. (4) An outpatient renal dialysis facility shall make all requested documents and records available to the surveyor for review and copying. (5) Entrance conference: The Division's surveyor shall hold a conference with the person who is in charge of the facility at the time of the survey for the purpose of explaining the nature and scope of the survey. (6) An on-site survey may include, but not be limited to: (a) Equipment; (b) Water treatment and reuse; (c) Infection control; (d) Quality assurance/Quality Assessment and Performance Improvement; (e) Provision for and coordination of treatment; (f) Staff qualifications; (g) Facility staffing; (h) Medical director involvement; (i) Patients' rights; (j) Physical environment; (k) Emergency management; (l) Interviews of patients, patient family members, facility management and staff; (m) On-site observations of patients, staff performance, and the physical environment of the facility; (n) Review of documents and records; and (o) Patient audits. (7) Following a survey, Division staff may conduct an exit conference with the facility administrator or his or her designee. During the exit conference Division staff shall: (a) Inform the facility representative of the preliminary findings of the survey; and (b) Give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings. (8) Following the survey, Division staff shall prepare and provide the facility administrator or his or her designee specific and timely written notice of the findings. (9) If the findings result in a referral to another regulatory agency, Division staff shall submit the applicable information to that referral agency for its review and determination of appropriate action. (10) If no deficiencies are found during a survey, the Division shall issue written findings to the facility administrator indicating that fact. (11) If deficiencies are found, the Division shall take informal or formal enforcement action in compliance with OAR 333-700-0062 or 333-501-0063. Statutory/Other Authority: ORS 441.015 & 441.025 Statutes/Other Implemented: ORS 441.025 & 441.060 History: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12 PH 7-2003, f. & cert. ef. 6-6-03