1240.1.
(a) For purposes of this section, the following terms have the following meanings:(1) “Staffing-related violation” means any of the following:
(A) Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of subdivision (b) of Section 1226.4.
(B) Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, intended to conceal a violation of
subdivision (b) of Section 1226.4.
(C) A misrepresentation of information provided to the department pursuant to this section or subdivision (d) of Section 1226.4.
(D) Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (d) or (e).
(E)Other violations that the department has defined in regulation.
(2) “Gross staffing-related violation” means any of the following:
(A) A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.
(B) A willful or intentional staffing-related violation.
(C) Reckless A staffing-related violation that occurred following reckless disregard of a substantial likelihood of a staffing-related violation.
(D) Five or more staffing-related violations in a 12-month period.
(E) Being out of compliance with one of the staffing ratios specified in paragraph (1) of subdivision (b) of Section 1226.4 for a period of time that extends beyond a single working shift of a nurse, for purposes of the nurse staffing requirement, or a single working shift of a technician, for purposes of the technician staffing requirement. For purposes of this subparagraph, the terms “nurse” and “technician” shall have the same meanings as in Section 1226.4.
(F) A continuous period of one week or longer in which the
staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, “social worker” has the same meaning as in Section 1226.4.
(G) A daily average transition time for a treatment station that is 20 minutes or shorter.
(H)Other violations that the department has defined in regulation.
(3) “Governing entity” means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity
itself directly holds that license.
(4) “Responsible individual” means a person described in subparagraph (A) or (B) who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known that the violation would occur and possessed, but failed to exercise, direct responsibility and authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, direct responsibility and authority to substantially remedy the violation.
(A) A member of the governing body, designated person, chief executive officer, and administrator, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B) Managerial employees, officers, or directors of the governing
entity.
(b) (1) The department may impose civil penalties of up to one thousand dollars ($1,000) on a chronic dialysis clinic for repeated staffing-related violations in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (d) and (e).
(2) For the third staffing-related violation in any 12-month period:
(A) The department may impose a civil penalty on the chronic dialysis clinic of up to two thousand dollars ($2,000).
(B) The department may impose a civil penalty on each responsible individual, if any, of
up to five hundred dollars ($500).
(3) For the fourth staffing-related violation in any 12-month period:
(A) The department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand dollars ($2,000) and not more than five thousand dollars ($5,000).
(B) The department shall impose a civil penalty on each responsible individual, if any, of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).
(c) Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under
this subdivision shall be in addition to actions required or authorized under subdivisions
(d) and (e).
(1) For the first gross staffing-related violation in any 24-month period, the department may impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than five thousand dollars ($5,000).
(2) For the second gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than ten thousand dollars ($10,000).
(3) For the third gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five
thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.
(4) For the fourth gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.
(5) For the fifth gross staffing-related violation in any 24-month period:
(A) The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars
($5,000) and not more than ten thousand dollars ($10,000), and may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.
(B) For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis
clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(6) For the sixth and each subsequent gross staffing-related violation in any 24-month period:
(A) The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.
(B) For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an
affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(d) Following any enforcement action taken by the department under subdivision (b) or (c), the chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations or gross staffing-related violations, as applicable. The corrective action plan shall be reviewed and approved by the department.
(e) Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or
authorized under subdivisions (b), (c), and (d).
(1) Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:
(A) The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.
(B) The department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:
(i) Three years after the latest gross staffing-related violation occurred.
(ii) The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).
(2) When chronic dialysis
clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:
(A) The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.
(B) The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic
that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.
(f) (1) The department shall consider the factors described in paragraph (2) for all of the following:
(A) When determining the penalties to be imposed under subdivision (b).
(B) The revisions, if any, to corrective action plans submitted under subdivision (d) or (e).
(C) The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (e).
(D) Whether to take any other action authorized under subdivision (b), (c), or (e).
(2) The department shall consider all of the following factors when taking the actions described in paragraph (1):
(A) The duration and severity of the violation.
(B) The willfulness of the violation.
(C) The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.
(D) The ability and good
faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.
(E) The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.
(F) The harm to any patient, or exacerbation of that harm, resulting from the violation.
(G) The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.
(g) Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.
(h) For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.
(i) If a licensee disputes a determination by the department regarding the imposition of a penalty pursuant to this section, the licensee may, within 10 working days, request a hearing pursuant to Section 131071. Penalties shall be paid when all appeals have been exhausted and the department’s position has been upheld.