| (a) The department may conduct an inspection at any time to verify compliance with the statute or this chapter. By applying for or holding a license, the facility consents to entry and inspection of the facility by the department or representative of the department in accordance with the statute and this chapter. (1) An authorized representative of the department (surveyor) may enter the premises of a license applicant or license holder at reasonable times during business hours to conduct an on-site inspection incidental to the issuance of a license, and at other times as the department considers necessary to ensure compliance with: (A) the statute or this chapter; (B) an order of the commissioner; (C) a court order granting injunctive relief; (D) a corrective action plan; or (E) other enforcement action(s). (2) The surveyor is entitled to access all books, records, or other documents maintained by or on behalf of the facility, interview patients and staff to the extent necessary to ensure compliance with the statute, this chapter, an order of the commissioner, a court order granting injunctive relief, a corrective action plan, or other enforcement action. The department shall maintain the confidentiality of facility records as applicable under federal or state law. Ensuring compliance includes permitting photocopying by the department or providing photocopies to a department surveyor of any records or other information by or on behalf of the department as necessary to determine or verify compliance with the statute or this chapter. (b) Types of inspections. (1) Construction inspection. (A) The department shall conduct an inspection to determine compliance with the spatial, physical plant, and system requirements described in §117.102 of this title (relating to Construction Requirements for a New End Stage Renal Disease Facility), the requirements in §117.31(a) and (c) of this title (relating to Equipment), and §117.32(b) and (c) of this title (relating to Water Treatment, Dialysate Concentrates, and Reuse) prior to issuance of the initial license. (B) During any license period, the department may conduct a construction inspection to determine whether modifications or renovations comply with §117.102 of this title. (2) A department surveyor may conduct an initial inspection after the date of issuance of the initial license to determine if the facility meets the requirements of the statute and this chapter. The initial inspection is an evaluation of compliance with all requirements of the statute and this chapter. (3) At the department's discretion, a department surveyor may perform an on-site inspection prior to renewal of a facility license to verify compliance with the statute and this chapter. The renewal inspection may include an evaluation of compliance with all requirements of the statute and this chapter. (4) The department surveyor shall perform an inspection of a facility on site or by mail, if the facility has demonstrated noncompliance with the statute or this chapter, or to investigate a complaint received by the department. (5) After review of a facility's annual report, the department may request additional information, or conduct an inspection by mail or on site to determine compliance with the statute and this chapter. (6) The department may conduct an inspection incidental to an incident report as described in §117.48 of this title (relating to Incident Reports). (7) A department surveyor shall perform an inspection on site or by mail to verify completion of a corrective action plan(s) for deficiencies cited during any of the inspections described in paragraphs (1) - (6) of this subsection. (c) Inspection procedures. (1) The department's surveyor shall hold an entrance conference with the person who is in charge of the facility prior to commencing the inspection for the purpose of explaining the nature and scope of the inspection. (2) Except for the purposes of conducting an inspection under subsection (b)(1), (4), (6), or (7) of this section, an on-site inspection shall include an evaluation to determine compliance with the statute and this chapter. (3) Following an inspection of a facility the surveyor shall hold an exit conference with the facility administrator or his or her designee. During the exit conference, the surveyor shall: (A) fully inform the facility representative of the preliminary finding(s) of the inspection; (B) inform the facility representative regarding the preliminary finding(s) of the inspection of those circumstances which are potentially serious, serious, or life-threatening; (C) give the facility representative a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings before the surveyor exits the facility; and (D) identify any records that were duplicated. (4) Written notice of findings. (A) The surveyor shall: (i) prepare and provide the facility administrator or his or her designee specific and timely written notice of the findings in accordance with subparagraphs (B) and (C) of this paragraph; and (ii) if the findings result in a referral described in §117.81(a) of this title (relating to Corrective Action Plan), the surveyor may submit a written summary of the findings to the medical review board for its review and recommendation for appropriate action by the department. (B) If no deficiencies are found during an inspection, the department shall provide a statement indicating this fact. (C) If the written notice of findings includes deficiencies, the department and the facility shall comply with the procedure set out in this subparagraph. (i) The department shall provide the facility with a statement of the deficiencies not later than the 10th working day after the exit conference. (ii) The facility administrator or administrator's designee shall sign the written statement of deficiencies and return it to the department with an acceptable corrective action plan(s) for each deficiency no later than 10 working days of the facility's initial receipt of the statement of deficiencies. The signature does not indicate the administrator's or designee's agreement with deficiencies stated on the form. If the corrective action plan(s) is not acceptable to the department, the department shall notify the facility in writing and request that the corrective action plan(s) be modified and resubmitted no later than 10 working days from the facility's receipt of such request. (iii) The facility shall come into compliance 60 calendar days prior to the expiration date of the license or no later than the dates designated in the corrective action plan(s), whichever comes first. (iv) The requirements in clause (i) of this subparagraph do not apply if the surveyor's written notice of findings results in a referral to the medical review board as described in subparagraph (A)(ii) of this paragraph. (v) A corrective action plan completion date shall not exceed 45 calendar days from the date the deficiency(ies) is cited (exit date of the survey). (vi) The facility may challenge any deficiency cited after receipt of the statement of deficiencies. A challenge to a deficiency(ies) shall be in accordance with this subparagraph. (I) The facility shall comply with clause (ii) of this subparagraph regardless of its intent to challenge the deficiency(ies). (II) An initial challenge to a deficiency(ies) shall be submitted in writing no later than five working days from the facility's receipt of the statement of deficiencies to the applicable zone office. (III) If the initial challenge is favorable to the department, the facility may request a review of the initial challenge by submitting a written request to the Director or his or her designee, Patient Quality Care Unit, Department of State Health Services. The facility shall submit its written request for review of the initial challenge no later than five working days from its receipt of the department's response to the initial challenge. The department shall not accept or review any documents that were not submitted with the initial challenge. A determination by the director of the patient quality care unit relating to a challenge to a deficiency(ies) is the department's final determination concerning the challenge. (IV) The department shall respond to any written challenge submitted under subclause (II) or (III) of this clause no later than 15 working days from its receipt. (V) The department shall determine if a written corrective action plan(s) is acceptable. If the corrective action plan(s) is not acceptable to the department, the department shall notify the facility in writing and request that the corrective action plan(s) be modified and resubmitted no later than 10 working days from the facility's receipt of such request. Cont'd... |
