BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 1246
          AUTHOR:        Hernandez
          AMENDED:       April 12, 2012
          HEARING DATE:  April 18, 2012
          CONSULTANT:    Marchand

           SUBJECT  :  Health facilities: staffing.
           
          SUMMARY  :  Requires periodic inspections by the Department of 
          Public Health (DPH) to include a review of compliance with nurse 
          staffing ratios and patient classification systems, deems a 
          hospital's failure to have a patient classification system to be 
          an immediate jeopardy violation subject to higher fine amounts, 
          and eliminates a requirement that DPH promulgate regulations 
          further defining the criteria for assessing administrative 
          penalties, thereby allowing existing fine authority to go into 
          effect.

          Existing law:
          1.Licenses and regulates health facilities by DPH.

          2.Requires DPH to inspect for compliance with state laws and 
            regulations during a state periodic inspection or at the same 
            time as a federal periodic inspection.  Requires, for general 
            acute care hospitals, acute psychiatric hospitals, and special 
            hospitals, the inspection to be conducted no less than once 
            every three years.

          3.Requires DPH to adopt regulations that establish minimum, 
            specific, and numerical licensed nurse-to-patient ratios, by 
            licensed nurse classification and by hospital unit, for 
            hospitals, and requires these ratios to constitute the minimum 
            number of registered and licensed nurses that must be 
            allocated.

          4.Establishes a structure under which DPH is permitted to assess 
            administrative fines to general acute care hospitals, acute 
            psychiatric hospitals, and special hospitals for violation of 
            any of their licensing laws and regulations. Requires DPH to 
            promulgate regulations establishing the criteria to assess 
            these administrative penalties, and requires these criteria to 
            include, but not be limited to, the following:
                  a.        The patient's physical and mental condition;
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                  b.        The probability and severity of the risk that 
                    the violation presents to the patient;
                  c.        The actual financial harm to patients, if any;
                  d.        The nature, scope, and severity of the 
                    violation;
                  e.        The facility's history of compliance with 
                    related state and federal statutes and regulations;
                  f.        Factors beyond the facility's control that 
                    restrict the facility's ability to comply with state 
                    law;
                  g.        The demonstrated willfulness of the violation; 
                    and
                  h.        The extent to which the facility detected the 
                    violation and took steps to immediately correct the 
                    violation and prevent the violation from recurring.
          5.Permits DPH, on the effective date of the regulations required 
            above, to assess an administrative penalty against a general 
            acute care hospital, acute psychiatric hospital, and special 
            hospital, for a deficiency constituting an immediate jeopardy 
            violation, as defined, up to a maximum of $75,000 for the 
            first administrative penalty, up to $100,000 for the second 
            administrative penalty, and up to $125,000 for the third and 
            every subsequent administrative penalty. 

          6.Permits DPH, on the effective date of the regulations, to 
            assess an administrative penalty of up to $25,000 per 
            violation for those not deemed to constitute immediate 
            jeopardy.

          7.Prohibits DPH from assessing an administrative penalty for 
            minor violations.

          8.Defines "immediate jeopardy" as a situation in which the 
            licensee's noncompliance with one or more requirements of 
            licensure has caused, or is likely to cause, serious injury or 
            death to the patient.

          9.Permits DPH, prior to the effective date of the regulations 
            required above, to assess immediate jeopardy administrative 
            penalties of up $50,000 for the first administrative penalty, 
            up to $75,000 for the second administrative penalty, and up to 
            $100,000 for the third and every subsequent administrative 
            penalty.

          10.Requires DPH to have full discretion to consider all factors 
            when determining the amount of an administrative penalty.




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          This bill:
          1.Requires that periodic DPH inspections of hospitals to ensure 
            compliance with state laws and regulations shall include a 
            review of compliance with nurse staffing ratios and patient 
            classification systems.

          2.Codifies existing regulations requiring hospitals to maintain, 
            and annually update, a patient classification system, 
            including regulations requiring the annual updating to be done 
            by a review committee appointed by the nursing administration, 
            at least one-half of which is required to be registered nurses 
            who provide direct patient care.

          3.Deems a hospital's failure to maintain a patient 
            classification system as an immediate jeopardy violation.

          4.Deems a hospital's failure to comply with the patient 
            classification system, including annual updates, as a 
            non-immediate jeopardy violation.

          5.Eliminates the requirement that DPH promulgate regulations 
            further defining criteria for assessing administrative fines, 
            so that existing law allowing fines of up to $25,000 for 
            non-immediate jeopardy violations, as well as higher immediate 
            jeopardy violation fine levels, can go into effect.

          6.Adds compliance with staffing requirements, including patient 
            classification systems and nurse-to-patient ratios, to the 
            existing criteria by which DPH is required to consider to 
            determine the amount of an administrative penalty.

          7.Requires the direct care nurses who are appointed to the 
            hospital committee which reviews the patient classification 
            system to be selected by the collective bargaining agent, if 
            any. 

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal 
          committee.

           COMMENTS  :  
           1.Author's statement.  According to the author, under existing 
            law, there is no specific mechanism to ensure that hospitals 
            are complying with nurse staffing ratios or patient 
            classification systems, nor do hospitals face any penalties 




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            for failure to comply with these laws and regulations.  SB 
            1246 will strengthen the existing nurse-to-patient staffing 
            ratio requirements in California hospitals by requiring DPH to 
            check for compliance during regular periodic inspections, and 
            by putting into effect existing statutory fine authority for 
            DPH by removing the requirement that DPH issue regulations. 
            Additionally, this bill codifies existing regulations relating 
            to patient classification systems, and authorizes an immediate 
            jeopardy fine for hospitals that have not established a 
            patient classification system - which has been a requirement 
            for hospitals for more than 15 years.

          2.Nurse to patient ratios and patient classification systems.  
            In 2004, regulations implementing nurse-to-patient ratios in 
            California hospitals pursuant to AB 394 (Kuehl), Chapter 945, 
            Statutes of 1999, went into effect.  However, long before 
            California had specific nurse-to-patient ratios, hospitals 
            were required by regulation to establish a patient 
            classification system.  This patient classification system is 
            a method by which hospitals establish staffing requirements by 
            unit, patient, and shift, and includes a method by which the 
            amount of nursing care needed for each category of patient is 
            validated for each unit.

          The regulations implementing the AB 394 nurse-to-patient ratios 
            law set the minimum ratio of nurses to patient by unit, 
            including one-to-one in operating rooms, one-to-two in 
            intensive care units, and one-to-five in general 
            medical-surgical units. These regulations also incorporated 
            the patient classification system requirement. In essence, the 
            specific nurse-to-patient ratios establish the minimum number 
            of nurses by unit, while the patient classification system 
            determines whether there needs to be a higher level of 
            staffing beyond the minimum ratio after taking into 
            consideration factors such as the severity of the illness, the 
            need for specialized equipment and technology, and the 
            complexity of clinical judgment needed to evaluate the patient 
            care plan, among other factors. The nurse-to-patient ratio 
            regulations require that the minimum ratios must be met at all 
            times.

          Finally, the regulations require the reliability of the patient 
            classification system for validating staffing requirements to 
            be reviewed at least annually by a committee appointed by the 
            nursing administrator to determine whether the system 
            accurately measures patient care needs.  At least half of the 




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            members of this committee are required to be registered nurses 
            who provide direct patient care.

          3.DPH enforcement of nurse-to-patient staffing requirements
          At an October 20, 2010 hearing of the Senate Health Committee on 
            DPHs implementation of recent patient safety legislation, DPH 
            testified that it does not inspect for compliance with 
            nurse-to-patient staffing ratios in the course of regular and 
            periodic inspections of hospitals. DPH stated that if it 
            identifies quality-of-care problems during routine 
            inspections, survey staff may look at nurse-to-patient 
            staffing ratios to determine if the hospitals' compliance with 
            the ratios is a factor. DPH also stated that it conducts large 
            numbers of complaint investigations alleging violations of 
            nurse-to-patient staffing ratios, and that it assigns these 
            complaints a higher priority for investigation because of the 
            potential for patients to be receiving inadequate care.  

            According to DPH, it has issued 465 deficiencies since January 
            2004 related to nurse-to-patient staffing ratios, and has 
            issued two hospitals penalties of $25,000 each for staffing 
            violations that it determined constituted immediate jeopardy 
            to patients, i.e. caused, or could have cause injury or death 
            to patients. DPH stated that it conducts follow-up surveys of 
            these deficiencies, on a case by case basis, depending on the 
            hospital's compliance history and the extent of the impact on 
            patient care of the deficiencies, but does not routinely 
            conduct follow-up surveys to determine if hospitals are 
            complying.

            In response to concerns that it was not routinely inspecting 
            hospitals for compliance with patient safety requirements, DPH 
            in 2010 developed a Patient Safety Licensing Survey, which it 
            uses to assess hospitals' compliance with the requirements of 
            11 patient safety statutes enacted since 2006 during regular 
            and periodic inspections.  Among the requirements that DPH 
            surveys for compliance on a regular basis are those pertaining 
            to hospital infection control procedures and practices and 
            discharge planning procedures.  Compliance with hospital 
            nurse-to-patient staffing requirements is not part of the 
            patient safety survey.  
           
           4.Administrative penalties for hospitals.  SB 1312 (Alquist), 
            Chapter 895, Statutes of 2006, gave DPH (formerly Department 
            of Health Services �DHS]) the authority to assess 




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            administrative penalties for violations of the laws pertaining 
            to the licensing of hospitals. Prior to SB 1312, DPH had very 
            limited authority to levy fines on hospitals that violated 
            state licensing laws. SB 1312 created two levels of penalties: 
            violations that constituted immediate jeopardy to the health 
            and safety of a patient, and violations that do not constitute 
            immediate jeopardy. SB 541 (Alquist), Chapter 605, Statutes of 
            2008, modified the administrative penalty provisions, and 
            increased the fine amounts. Immediate jeopardy violations are 
            now subject to a fine of up to $50,000 for the first 
            administrative penalty, $75,000 for the second penalty, and up 
            to $100,000 for the third and every subsequent violation. Once 
            regulations are adopted by DPH, these immediate jeopardy 
            penalties will increase to up to $75,000 for the first 
            penalty, $100,000 for the second penalty, and $125,000 for the 
            third and subsequent penalties. All other violations (except 
            minor violations, for which DPH is prohibited from assessing a 
            violation) are subject to a fine of up to $25,000.

          SB 1312 required DPH to promulgate regulations establishing the 
            criteria to assess administrative penalties, and listed eight 
            factors on which to base the criteria, including the patient's 
            physical and mental condition, the nature, scope and severity 
            of the violation, and the demonstrated willfulness of the 
            violation. However, DPH is authorized to assess immediate 
            jeopardy penalties without waiting for the regulations; DPH 
            does not have this authority for non-immediate jeopardy 
            violations. Because DPH has still not promulgated the 
            regulations required by SB 1312, DPH does not have the ability 
            to assess the penalties of up to $25,000 for violations that 
            do not rise to the level of immediate jeopardy.

          5.Related legislation. SB 554 (Yee) from 2011 proposed to 
            require DPH to inspect for compliance with nurse-to-patient 
            staffing ratios during periodic inspections of hospitals, 
            similar to this bill. SB 554 also proposed to require DPH to 
            inspect hospitals that have been cited for deficiencies 
            related to nurse-to-patient staffing ratios for their 
            compliance with the plan of correction.  SB 554 also would 
            have required DPH to assess administrative penalties for 
            violations of nurse-to-patient staffing ratios and for failure 
            to comply with an approved plan of correction related to 
            nurse-to-patient ratios. The penalties included a $10,000 
            penalty for the fourth and each subsequent violation of the 
            nurse-to-patient ratio requirements within a six-month period, 
            and $10,000 for the failure of the hospital to comply with an 




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            approved plan of correction. These provisions were later 
            amended out of the bill.

          6.Prior legislation.  SB 541 (Alquist), Chapter 605, Statutes of 
            2008, increased the level of administrative penalties DPH may 
            assess against hospitals, including for deficiencies that 
            constitute immediate jeopardy to the health or safety of 
            patients. Requires health care facilities to prevent unlawful 
            or unauthorized access to use, or disclosure of, patients' 
            medical information, and to established safeguards protecting 
            the privacy of patients' medical information.

          SB 1312 (Alquist), Chapter 895, Statutes of 2006, authorizes DHS 
            (now DPH) to assess administrative penalties on hospitals for 
            deficiencies constituting immediate jeopardy to the health and 
            safety of a patient and those that do not constitute immediate 
            jeopardy to patients.

          SB 360 (Yee) of the 2009-10 Session would have required each new 
            direct care registered nursing hire to receive and complete an 
            orientation to the hospital and patient care unit in which he 
            or she will be working. Nurses who have not completed this 
            orientation would not be allowed to be assigned to direct 
            patient care or be counted as staff in computing 
            nurse-to-patient ratios. Held under submission in Senate 
            Appropriations Committee.

          SB 1721 (Yee) of the 2007-2008 Session contained provisions that 
            were similar to the provisions of SB 360. Held in Assembly 
            Appropriations Committee.

          SB 1760 (Kuehl), Chapter 148, Statutes of 2000, provided a 
            one-year extension for the adoption of regulations 
            establishing specified nurse-to-patient staff ratios in health 
            facilities.

          AB 394 (Kuehl), Chapter 945, Statutes of 1999, required DPH to 
            adopt regulations specifying nurse-to-patient ratios, by unit, 
            for general acute care hospitals, acute psychiatric hospitals 
            and special hospitals. Required hospitals to adopt written 
            policies and procedures for nursing staff training. Provided 
            that the ratios shall constitute the minimum number of 
            registered and licensed nurses that must be provided; requires 
            hospitals to assign additional staff in accordance with a 
            documented patient classification system.




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          7.Support.  United Nurses Associations of California/Union of 
            Health Care Professionals (UNAC/UHCP), the sponsor of this 
            bill, states that this bill would protect consumers by 
            enforcing existing laws and regulations regarding nurse 
            staffing in hospitals. UNAC/UHCP states that DPH does not 
            survey for compliance with staffing requirements and cannot 
            fine a hospital that violates such requirements. According to 
            UNAC/UHCP, over the last decade, a considerable body of 
            academic literature has established that staffing in 
            compliance with the nurse-to-patient ratios required under 
            California law improves patient outcomes, yet DPH fails to 
            assure patients of the protections of law by failing to survey 
            for compliance with ratios and patient classification systems. 
            Additionally, UNAC/UHCP states that DPH has failed to avail 
            itself of the intermediate sanctions because of its abject 
            failure to move regulations forward. While UNAC/UHCP 
            understands that DPH has plans to adopt a variety of 
            regulations over the next decade, UNAC/UHCP argues that 
            patients can't wait and the law should be enforced.
          8.Opposition.  The California Hospital Association (CHA) opposes 
            this bill, stating that California hospitals have been 
            mandated to implement and maintain patient classification 
            systems for the past 16 years, and the practice is considered 
            a standard of care.  CHA states that DPH routinely monitors 
            hospital compliance during their periodic inspections, and 
            that surveyors use reasonable judgment and just cause when 
            surveying to identify areas of concern.  CHA states that this 
            may or may not include review of the patient acuity 
            classification system, and that additional mandatory review of 
            such practices as outline in this bill is unreasonable.  CHA 
            also states that the $100,000 immediate jeopardy penalty 
            proposed by this bill for not having a patient classification 
            system is disproportionate to the value of the tool for the 
            successful care of patients.  Finally, CHA is opposed to the 
            requirement that direct care nurses who are appointed to the 
            patient classification committee be selected by the collective 
            bargaining agent, if there is one at the hospital.  CHA states 
            that hospitals are already required to have a patient 
            classification system committee with members appointed by the 
            Nursing Service Administrator.  CHA states that while it 
            agrees that patient acuity is a concept that is essential to 
            patient safety, patient acuity classification systems have 
            numerous limitations and cannot be the only metric used for 
            staffing and cannot guarantee adequate staffing.
          




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           SUPPORT AND OPPOSITION  :
          Support:  American Federation of State, County and Municipal 
                    Employees (co-sponsor)
                    United Nurses Associations of California/Union of 
                         Health Care Professionals (co-sponsor)
                    
          Oppose:   California Hospital Association

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