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SB-349 Chronic dialysis clinics: staffing requirements.(2017-2018)

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Date Published: 05/26/2017 10:00 AM
SB349:v94#DOCUMENT

Amended  IN  Senate  May 26, 2017
Amended  IN  Senate  May 03, 2017
Amended  IN  Senate  April 17, 2017
Amended  IN  Senate  April 03, 2017
Amended  IN  Senate  March 20, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill No. 349


Introduced by Senator Lara
(Coauthors: Senators Bradford, Hertzberg, and Newman)

February 14, 2017


An act to amend Sections 1226 and 1228 of, to add Sections 1226.4, 1240.1, and 1266.2 to, and to repeal and add the heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of, the Health and Safety Code, relating to clinics.


LEGISLATIVE COUNSEL'S DIGEST


SB 349, as amended, Lara. Chronic dialysis clinics: staffing requirements.

Existing

(1) Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that a chronic dialysis clinic submit a corrective action plan. authorize the department to assess an administrative penalty for a violation of these provisions and would require the department to promulgate regulations to establish criteria for assessing these penalties. The bill would authorize a chronic dialysis clinic that disputes an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation, or an amount of an administrative penalty to request a hearing. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, this bill would impose a state-mandated local program.

Existing

(2) Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would generally require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.

The

(3) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 The Legislature finds and declares all of the following:
(a) Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.
(b) There are currently more than 63,000 dialysis patients, and 562 licensed outpatient dialysis clinics, in California.
(c) There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d) There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e) Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f) Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g) Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.

SEC. 2.

 Section 1226 of the Health and Safety Code is amended to read:

1226.
 (a) The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b) The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c) (1) A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2) Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3) If the city or county indicates that its review will include this certification, it shall do both of the following:
(A) Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B) Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d) If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e) When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f) The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g) Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h) Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.

SEC. 3.

 Section 1226.4 is added to the Health and Safety Code, to read:

1226.4.
 (a) For purposes of this section, the following terms have the following meanings:
(1) “At all times” includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2) “Charge nurse” means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3) “Direct care” means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed. dialysis treatment area.
(4) “Nurse” means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5) “Nurse manager” means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6) “Registered dietitian” means a dietitian as described in Section 494.140 (c) of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016.

(6)

(7) “Social worker” means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.

(7)

(8) “Technician” means a person who holds both of the following qualifications:
(A) The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B) The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.

(8)

(9) “Trainee” means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.

(9)

(10) “Transition time” means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.

(10)

(11) “Treatment station” means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b) (1) Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A) At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B) At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2) Commencing January 1, 2019, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3) Commencing January 1, 2019, a chronic dialysis clinic shall ensure that a registered dietitian is not assigned more than 75 patients.

(3)

(4) The ratios described in paragraphs (1) and (2) (1), (2), and (3) shall constitute the minimum number of nurses, technicians, and social workers social workers, and registered dietitians assigned to patients at all times. Additional nurses, technicians, and social workers social workers, and registered dietitians shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.

(4)

(5) Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c) The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d) (1) Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A) Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, social workers, and registered dietitians the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B) Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2) The chief executive officer or administrator of the chronic dialysis clinic shall personally certify that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3) The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e) The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f) Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, committed a violation of the requirements of this chapter, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g) (1) Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e) of this section, and subdivisions (b) to (g), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).
(2) The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254 of the Government Code.
(3) Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.

SEC. 4.

 Section 1228 of the Health and Safety Code is amended to read:

1228.
 (a) Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b)  (1) During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the department’s responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2) The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c) This section shall not apply to any of the following:
(1) A rural health clinic.
(2) A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3) An ambulatory surgical center.
(4) A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d) Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.

SEC. 5.

 The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.

SEC. 6.

 The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:
Article  5. Suspension, Revocation, and Penalties
SEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:
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).

(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)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.

(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 nonmanagerial employee shall not be deemed a responsible individual.

(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).

(C)In making the determination under subparagraph (B) the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.

(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.

(C)In making this determination the department shall consider the actual average of violations among the chronic dialysis clinics of 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 chronic dialysis clinic or a responsible individual disputes a determination by the department regarding the imposition of a penalty pursuant to this section, the chronic dialysis clinic or responsible individual 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.

SEC. 7.

 Section 1240.1 is added to the Health and Safety Code, to read:

1240.1.
 (a) The director may assess an administrative penalty against a chronic dialysis clinic for a violation of this chapter. Each penalty issued pursuant to this chapter shall be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. A major violation shall be subject to an administrative penalty of up to ten thousand dollars ($10,000), and an intermediate violation shall be subject to an administrative penalty of up to five thousand dollars ($5,000). The director shall not assess an administrative penalty for a minor violation.
(b) The department shall promulgate regulations establishing the criteria to assess an administrative penalty against a chronic dialysis clinic, that shall include, but not be limited to, a consideration of all of the following:
(1) The probability and severity of the risk that the violation presents to the patient.
(2) The actual harm to patients, if any.
(3) The nature, scope, and severity of the violation.
(4) The chronic dialysis clinic’s history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the chronic dialysis clinic within a 24-month period.
(5) Factors beyond the control of the chronic dialysis clinic that restricts its ability to comply with this chapter or the rules and regulations promulgated thereunder.
(6) The demonstrated willfulness of the violation.
(7) The extent to which the chronic dialysis clinic detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
(c) If a chronic dialysis clinic disputes a determination by the director regarding an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, the chronic dialysis clinic may, within 10 working days, request a hearing pursuant to Section 131071. A chronic dialysis clinic shall pay all administrative penalties when all appeals have been exhausted and the department’s position has been upheld.

SEC. 8.

 Section 1266.2 is added to the Health and Safety Code, to read:

1266.2.
 It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.

SEC. 9.

 Nothing in this act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code.

SEC. 10.

 The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.

SEC. 11.

 The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.

SEC. 12.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.