1 West Wilson St., Room 1150
Madison, WI 53701
Phone: 608-264-9896
Fax: 608-267-7119
Submission of Written Comments
Comments may be submitted to Pat Benesh, as shown above or to the Wisconsin Administrative Rules Website at
http://adminrules.wisconsin.gov until
December 15, 2009, 4:30 p.m.
Analysis Prepared by the Department of Health Services
Statutes interpreted
Statutory authority
Explanation of agency authority
Section
50.36 (1), Stats., requires the department to promulgate rules for the construction, maintenance and operation of hospitals deemed necessary to provide safe and adequate care and treatment of patients and to protect the health and safety of patients in a hospital. Section
50.377 (2), Stats., permits the department to directly assess forfeitures for violations of s.
50.375 (2) and
(3), Stats., relating to emergency contraception for sexual assault victims. Section
227.11 (2) (a), Stats., provides state agencies with general rulemaking authority to promulgate rules interpreting the provisions of any statute enforced or administered by the agency if the agency considers it necessary to effectuate the purpose of the statute.
Related statute or rule
See the “Statutes interpreted" and “Statutory authority" sections.
Plain language analysis
Section
157.06, Stats., specifies provisions relating to anatomical gifts. Under this proposed order, the department replaces the existing requirements under s.
DHS 124.05 (3) (i), with a requirement for hospitals to comply with relevant provisions relating to anatomical gifts under s.
157.06, Stats. The proposed rule removes the more prescriptive requirements on the subject.
Section
50.36 (5), Stats., requires that before providing emergency services in a hospital, medical and nursing personnel have proficiency in the use of an automated external defibrillator (AED) achieved through instruction provided by an individual, organization or institution that is approved by the department. Under this proposed order, the department creates s.
DHS 124.05 (3) (j), to require hospitals to ensure compliance with s.
50.036 (5), Stats., for use of automated external defibrillators by medical and nursing personnel.
Section
50.375, Stats., requires a hospital that provides emergency services to provide emergency contraception services to a female victim of sexual assault.
Section
50.377, Stats., provides that “[w]hoever violates a requirement under s.
50.375 (2) or
(3), Stats., may be required to forfeit not less than $2,500 nor more than $5,000 for each violation." There are 3 separate requirements under s.
50.375 (2), Stats., and one requirement under s.
50.375 (3), Stats. The department, under s.
50.377,
(2), Stats., may directly assess the forfeitures for violations of these requirements. Under this proposed order, the department establishes forfeiture dollar amounts for violations of s.
50.375 (2) and
(3), Stats., and the statutory requirements for notice of assessment and appeal rights relating to a forfeiture assessment.
A hospital that violates all 4 requirements would be subject to a total forfeiture of $10,000 for the first violation of those requirements, and a total forfeiture of $20,000 for a subsequent violation of the same requirements.
Comparison with federal regulations
Emergency contraception: There appear to be no existing or proposed federal regulations that address the activities to be regulated by the proposed rule.
Anatomical gifts:
42 CFR 482.45, Condition of Participation and
42 CFR 121, Organ Procurement and Transplantation Network, include requirements for hospitals relating to organ, tissue and eye procurement.
Automated external defibrillators: There appear to be no existing or proposed federal regulations that address the activities to be regulated by the proposed rule.
Comparison with rules in adjacent states
Illinois:
Emergency contraception: Illinois administrative code requires hospitals to provide medical and factually accurate written and oral information about emergency contraception and how and when victims may be provided emergency contraception. Hospitals that are found out of compliance with the code have 14 working days to submit a plan of correction to the state agency. If the hospital fails to submit an acceptable plan of correction or fails to implement the plan of correction within the time frames, the hospital is subject to the imposition of a fine of up to $100 per day until the hospital complies with the requirement of the code. Administrative Code Section: 77 Ill. Adm. Code 545.95 and 545.67. The proposed rule establishes forfeiture amounts as permitted under s.
50.389, Stats., for violations of s.
50.375 (2) or
(3), Stats., relating to emergency contraception for sexual assault victims.
Anatomical gifts: Illinois administrative code requires hospitals to have an agreement with its federally designated organ procurement agency providing for notification when potential organ donors become available and to provide access to the medical records of deceased patients. Administrative Code Section: 77 Ill. Adm. Code 250.280. The proposed rule requires hospitals to comply with relevant provisions under s.157.06, Stats., relating to anatomical gifts. The proposed rule removes the more prescriptive requirements on the subject.
Automated external defibrillators: Illinois administrative code requires users of AEDs to be trained. Administrative Code Section: 77 Ill. Adm. Code 525.400. The proposed rule requires hospitals to ensure compliance with s.
50.036 (5), Stats., for use of automated external defibrillators by medical and nursing personnel.
Iowa:
Emergency contraception: Iowa has no administrative code regarding emergency contraception in hospitals. The proposed rule establishes forfeiture amounts as permitted under s.
50.389, Stats., for violations of s.
50.375 (2) or
(3), Stats., relating to emergency contraception for sexual assault victims.
Anatomical gifts: Iowa has no administrative code regarding anatomical gifts in hospitals. The proposed rule requires hospitals to comply with relevant provisions under s.157.06, Stats., relating to anatomical gifts. The proposed rule removes the more prescriptive requirements on the subject.
Automated external defibrillators: Iowa has no administrative code regarding the use of automated external defibrillators in hospitals. The proposed rule requires hospitals to ensure compliance with s.
50.036 (5), Stats., for use of automated external defibrillators by medical and nursing personnel.
Michigan:
Emergency contraception: Michigan has no administrative code regarding emergency contraception in hospitals. The proposed rule establishes forfeiture amounts as permitted under s.
50.389, Stats., for violations of s.
50.375 (2) or
(3), Stats., relating to emergency contraception for sexual assault victims.
Anatomical gifts: Michigan has no administrative code regarding anatomical gifts in hospitals. The proposed rule requires hospitals to comply with relevant provisions under s.157.06, Stats., relating to anatomical gifts. The proposed rule removes the more prescriptive requirements on the subject.
Automated external defibrillators: Michigan has no administrative code regarding the use automated external defibrillators in hospitals. The proposed rule requires hospitals to ensure compliance with s.
50.036 (5), Stats., for use of automated external defibrillators by medical and nursing personnel.
Minnesota:
Emergency contraception: Minnesota has no administrative code regarding emergency contraception. The proposed rule establishes forfeiture amounts as permitted under s.
50.389, Stats., for violations of s.
50.375 (2) or
(3), Stats., relating to emergency contraception for sexual assault victims.
Anatomical gifts: Minnesota has no administrative code regarding anatomical gifts in hospitals. The proposed rule requires hospitals to comply with relevant provisions under s.157.06, Stats., relating to anatomical gifts. The proposed rule removes the more prescriptive requirements on the subject.
Automated external defibrillators
: Minnesota has no administrative code regarding the use automated external defibrillators in hospitals. The proposed rule requires hospitals to ensure compliance with s.
50.036 (5), Stats., for use of automated external defibrillators by medical and nursing personnel.
Summary of factual data and analytical methodologies
The Department relied on all of the following sources to draft the proposed rule to determine the impact on small businesses.
•
The Department solicited comments from representatives of the Wisconsin Hospital and Health Association, Wisconsin Public Psychiatric Hospital, Rural Wisconsin Health Cooperative and Planned Parenthood of Wisconsin. Representatives from these organizations reviewed the initial draft of the rule.
•
The 2002 Economic Census – Wisconsin Geographic Series, compiled by the U.S. census bureau every 5 years for each year ending in “2" and “7" and contains the latest available economic data (2007 data is not yet published-August 2009) compiled on businesses located in Wisconsin.
•
Criteria adopted by the Department and approved by the Wisconsin Small Business Regulatory Review Board to determine whether the Department's proposed rules have a significant economic impact on a substantial number of small businesses. Pursuant to the Department's criteria, a proposed rule will have a significant economic impact on a substantial number of small businesses if at least 10% of the businesses affected by the proposed rules are small businesses and if operating expenditures, including annualized capital expenditures, increase by more than the prior year's consumer price index or reduces revenues by more than the prior year's consumer price index. For the purposes of this rulemaking, 2008 is the index year. The consumer price index is compiled by the U.S. Department of Labor, Bureau of Labor Statistics; the preliminary rate for the Midwest in 2008 is currently estimated at 3.9 percent.
•
Section
227.114 (1) (a), Wisconsin Stats., defines “small business" as a business entity, including its affiliates, which is independently owned and operated and not dominant in its field, and which employees 25 or fewer full-time employees or which has gross annual sales of less than $5,000,000.
•
DHS databases including the Aspen information System which contains demographic, licensing, program, and compliance history of hospitals in Wisconsin.
Analysis and supporting documents used to determine effect on small business
The North American Industry Classification System (NAICS) includes hospitals in the Health Care and Social Assistance sector, (sector 62) and further defined in sub-sector 622 hospitals. Industries in the hospitals subsector provide medical, diagnostic, and treatment services that include physician, nursing, and other health services to inpatients and the specialized accommodation services required by inpatients. Hospitals may also provide outpatient services as a secondary activity. Establishments in the Hospitals subsector provide inpatient health services, many of which can only be provided using the specialized facilities and equipment that form a significant and integral part of the production process.
Employment statistics and revenue data from the 2002 NAICS dataset for Wisconsin report $9.4 billion in revenue with over 103,000 employees receiving over $3.5 billion in wages.
None of Wisconsin's hospitals meet the definition of a small business under s.
227.114 (1), Stats.
Small Business Impact
There is no fiscal impact on small business as defined in s.
227.114 (1), Stats., as none of Wisconsin's hospitals meet the definition of a small business.
Small business regulatory coordinator
Rosie Greer
608-266-1279
Fiscal Estimate
Under the proposed order, the department establishes forfeiture dollar amounts for violations of s.
50.375 (2) and
(3), Stats., relating to emergency contraception services to a female victim of sexual assault. The proposed forfeiture assessment ranges from $2,500 for a first violation to $5,000 for a subsequent violation. The Wisconsin constitution requires that all forfeitures are to be deposited in the Common School Fund with this department receiving no benefit from the forfeiture assessment. The State of Wisconsin operates 4 hospitals, 11 other hospitals are operated by counties or other local governmental entities and would be subject to forfeiture assessment if they were found to be out of compliance. There may be an increase in costs for government run hospitals that violate s.
50.375, Stats. There are no other provisions in the proposed rules beyond statutory requirements that would affect state or local government costs.
There is no fiscal impact on small business as defined in s.
227.114 (1), Stats., as none of Wisconsin's hospitals meet the definition of a small business.
A copy of the fiscal estimate may be obtained from the department upon request.
State fiscal effect
Indeterminate. Increase in costs that may be possible to absorb within the agency's budget.
Fund sources affected
GPR.
Affected Ch.
20 appropriations
Local government costs
Increase costs.
Local government units affected
Cities and Counties.
Private sector fiscal effect
None.
Agency Contact Person
Pat Benesh, Quality Assurance Program Spec-Senior
Division of Quality Assurance
1 West Wilson St., Room 1150
Madison, WI 53701
Phone: 608-264-9896
Fax: 608-267-7119
Notice of Hearing
Natural Resources
Fish, Game, etc., Chs.
NR 1—
NOTICE IS HEREBY GIVEN THAT pursuant to s.
227.11 (2) (a), Stats., the Department of Natural Resources will hold a public hearing on revisions to section
NR 45.04 (1) (g), Wis. Adm. Code, relating to regulation of firewood entering department lands. The proposed amendment would prohibit anyone from bringing onto department managed lands firewood from greater than 25 miles from the campground or property, from outside of Wisconsin, or from areas quarantined by the state, a federal agency or tribal government or designated zones of infestation if the property is outside of the quarantine or infested zone unless the firewood source is approved by the Wisconsin DATCP. The amendment also defines firewood for the use of this rule.
