Update: The bill, which has passed the California State Senate, has been amended and no longer includes the penalty structure described below. Read more.
California’s Senate Bill 349, called the Dialysis Patient Safety Act, has brought to the forefront a divide between clinic staff members and the patients they care for, and dialysis providers. Many dialysis nurses and patient care technicians have said they are stretched too thin and care for too many critically ill patients at once, putting lives at risk. Dialysis providers contend they are operating on thin margins in an already strictly regulated market.
If the bill becomes law, how would the ratios be enforced, and what would be the penalties for noncompliance? Below is an outline of many important provisions in the bill’s current version, as of May 9.
The regulations within the bill
The following staffing requirements must be met at all times in an outpatient dialysis clinic.
- At least one nurse must provide direct care for every eight patients. A nurse only counts toward this ratio if he/she has no other responsibilities other than direct patient care. A nurse manager or charge nurse does not count toward this ratio.
- At least one technician is providing direct care for every three patients. A technician only counts toward this ratio during periods in which the technician has no responsibilities other than direct care. Trainees and nurses included in the nurse ratio do not count toward this ratio.
- Each social worker must not be assigned more than 75 patients.
The bill would also require a minimum 45-minute transition time between patients.
How the regulations would be enforced
The bill mentions two ways to ensure clinic compliance: self reporting and submission of complaints.
Every dialysis clinic must submit a form to the the state department of public health with the following information:
- Staffing ratio and transition time data.
- Every instance, no matter how brief, when staffing ratios or transition times did not meet requirements.
The CEO or administrator of the dialysis clinic must personally certify that he/she is satisfied that all information submitted is accurate and complete.
The state department of public health would prescribe a schedule for submitting these forms, but the bill stipulates that the forms must be submitted at least four times a year. The department would inspect each dialysis clinic at least once per year.
If the department receives a complaint about a clinic not meeting the staffing requirements, the department would investigate the clinic within 60 days.
Types of violations
The bill provides a cascading list of penalties for noncompliance. There are two types of violations: “staffing-related violations” and “gross staffing-related violations.”
A staffing-related violation is any violation of the staffing requirements, attempts to conceal violations, and violations of corrective plans. Clinics can have two of these violations before receiving a penalty.
All gross-staffing related violations come with penalties, and the difference between the two types of violations can at times come down to intent. Intentional violations, and those that are a result of “reckless disregard,” are considered gross violations, and come with stiffer penalties.
A gross staffing-related violation includes the following:
- A violation that causes or exacerbates harm to a patient, or has the possibility of doing so.
- Intentional violations of the staffing requirements.
- A violation that occurs as the result of reckless disregard of the likelihood of a violation.
- Five or more staffing-related violations in a one-year period.
- Violating the requirements for longer than a single working shift of a nurse or technician.
- 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.
- A daily average transition time for a treatment station that is 20 minutes or shorter.
Penalties for noncompliance
Penalties can be imposed on dialysis clinics, dialysis corporations, and managerial employees. They can include fines up to $10,000, suspension or revocation of licenses, and the refusal to allow renewal or transfer of a license.
Penalties for staffing-related violations
These violations are considered consecutive if they occur within a 12-month period. Clinics can commit two of these violations before receiving a penalty.
- For the third staffing-related violation, a clinic can be fined up to $2,000 and a responsible individual (defined as an administrator, CEO, or member of the governing body who knew or should have known a violation would occur but did not prevent it, or knew or should have known that the violation had occurred and failed to remedy the violation) can be fined up to $500.
- For the fourth staffing-related violation, a clinic can be fined between $2,000 and $5,000, and a responsible individual can be fined between $200 and $4,000.
Penalties for gross staffing-related violations
These violations are considered consecutive if they occur in a 24-month period. The fines are more severe, and after three of these violations, penalties can include suspension or revocation of the clinic license.
Twenty-five or more gross staffing-related violations within any 24-month period would require a corrective plan, and can lead to the refusal to issue new licenses or transfer existing licenses until the state department is satisfied that the corrective plan has been followed.