Section 50.36 (6m), Stats., authorizes the department to grant a variance or a waiver of a requirement for hospitals. The proposed rule interprets the circumstances under which a waiver or variance would be seen to support the efficient and economic operation of the hospital. Maternity and neonatal care
Section 50.36 (1), Stats., provides that the department must use and enforce the conditions for Medicare participation for hospitals as quality control measures, but may promulgate such additional rules as it deems necessary for safe and adequate care of hospital patients and to protect the health and safety of the patients and employees. The department has determined that additional rules are necessary to address the care and treatment of maternity patients and newborns regarding personnel, admission, patient placement and transfer, delivery, security, labor inducing medication and nursery. Patient rights and responsibilities in critical assess hospitals
Section 50.36 (1), Stats., provides that the department must use and enforce the conditions for Medicare participation for hospitals as quality control measures, but may promulgate such additional rules as it deems necessary for safe and adequate care of hospital patients and to protect the health and safety of the patients and employees. The conditions of participation for Medicare do not address patient rights in the critical access hospital setting. Proposed rules establish patient rights similar to the rights in the previous provisions contained in s. DHS 124.05 (3) (a). Freestanding emergency departments
Section 50.36(1), Stats., provides that the department must use and enforce the conditions for Medicare participation for hospitals as quality control measures, but may promulgate such additional rules as it deems necessary for safe and adequate care of hospital patients and to protect the health and safety of the patients and employees. It was determined that additional rules were necessary to address physical environment, personnel, laboratory, and pharmacy and ambulance delivery in these settings. Physical environment
Existing rules under ch. DHS 124, subch. V, relating to the hospital’s physical environment, require hospitals to design, construct, and operate their facilities in accordance with the Life Safety Code, national standards on construction and fire safety established by the National Fire Protection Association. The rules also require that patient rooms be of sufficient size, supported by sanitary support spaces and afford the patient privacy and the means to contact staff, fire safe finishes, emergency procedures, and fire incident reporting to the department. Proposed rules require hospitals to meet the provisions of the Life Safety Code (LSC) adopted into the federal Conditions of Participation. Fee schedule for plan review
Section 50.36 (2) (a), Stats., requires the department to conduct plan reviews of all capital construction and remodeling projects of hospitals to ensure that the plans comply with applicable building code requirements under ch. 101, Stats., and with the physical plant requirements under ch. 50, Stats., or department rules. Section 50.36 (2) (b), Stats., requires the department to promulgate rules that establish a fee schedule for its services in conducting plan reviews. Proposed rules establish standards for plan reviews and prescribe a fee schedule for providing plan review services. Summary of, and comparison with, existing or proposed federal regulations
There appears to be no existing or proposed federal regulations that address the activities regulated by the proposed rule.
Comparison with rules in adjacent states
Illinois:
Plans of correction/waivers/variances: Illinois has no administrative code regarding plans of correction, waivers and variances.
Maternity and neonatal care: Illinois has extensive regulations regarding obstetric departments including standards related to accommodations and facilities for obstetric patients, personnel requirements medical personnel, procedures for care of mother and infants, identification of infants, pharmacy services, caesarean birth, labor, delivery, recovery and postpartum care, records and infant feeding.
Patient rights in critical access hospitals: Illinois has no administrative code regarding patient rights in critical access hospitals.
Freestanding emergency departments: Illinois has extensive regulations for freestanding emergency centers and a Certificate of Need program that reviews all applications for freestanding emergency centers. Illinois law allows a maximum of 10 freestanding emergency centers in the state.
Physical Environment: Illinois has extensive rules regarding hospital physical environment that address orientation and follow-up training for staff in the principles of asepsis, cross-infection and safe practices, adequacy of space and the structure and equipment kept in good repair and maintained in operating condition at all times. Emergency eclectic service and weekly inspections and testing of emergency generator are mandated. Standards also address the adequacy of water supply regulated by thermostatic or other control devices, ventilation, heating air condition and air exchange systems provide and maintained in good repaint and operating in a manner which will prevent the spread of infection and provide patient comfort. All sewage and liquid wastes are to be disposed of in a municipal sewage system where such facilities are available.
Plan review and fee schedule: The Illinois Department of Public Health, Design and Construction Section, is responsible for plan review for licensed hospitals. A certificate of need review board approval is required prior to plan review of any new construction involving additional bed capacity. Local municipalities individually enforce the state’s commercial building code. Plan review fees are based on a total of estimated fixed equipment value and the cost of construction.
Iowa:
Plans of correction/waivers/variances: Iowa has no administrative code regarding plans of correction, waivers and variances.
Maternity and neonatal care: Iowa has no administrative code regarding maternity and neonatal care.
Patient rights in critical access hospitals: Iowa has no administrative code regarding patient rights in critical access hospitals.
Freestanding emergency departments: Iowa has no administrative code regarding freestanding emergency departments.
Physical Environment: Iowa has no administrative code regarding physical environment.
Plan review and fee schedule: The Iowa State Fire Marshall Division, State Building Code Bureau requires all hospital projects involving federal regulations for new buildings, additions to existing buildings, remodeling or renovation of existing buildings and change of occupancy to undergo a plan review and inspection. Plan review fees are based on a total of estimated material, labor, and construction costs.
Michigan:
Plans of correction/waivers/variances: Michigan has no administrative code regarding plans of correction, waivers and variances.
Maternity and neonatal care: Michigan has rules for maternity hospitals and departments that require hospitals to meet physical plant standards, establish minimum policies regarding the use and administration of mediations, and provide required equipment and supplies, post-delivery and nursery procedures, care provided to the mother and the maintenance of medicals records.
Patient rights in critical access hospitals: Michigan has no administrative code regarding patient rights in critical access hospitals.
Freestanding emergency departments: Michigan has no administrative code regarding freestanding emergency departments.
Physical Environment: Michigan has no administrative code regarding physical environment.
Plan review and fee schedule: The Michigan Department of Licensing and Regulatory Affairs, Health Facility Engineering Section, provides plan review and inspection services for the design and construction of hospitals to ensure the safe, efficient, and effective delivery of healthcare. Plan review fees are based on a total of estimated fixed equipment value, professional fees, and the cost of construction.
Minnesota:
Plans of correction/waivers/variances: Minnesota has no administrative code regarding plans of correction, waivers and variances.
Maternity and neonatal care: Minnesota has rules for obstetrical department that establish minimum delivery room size, illumination, beds, equipment and obstetrical isolation facilities. Additional rules establish criteria for newborn nursery, bassinets, observation window, incubators and formula preparation.
Patient rights in critical access hospitals: Minnesota has no administrative code regarding critical access hospitals.
Freestanding emergency departments: Minnesota has no administrative code regarding freestanding emergency departments.
Physical Environment: Minnesota has general rules that require the hospital structure and equipment to be kept in good repair and operational all times with regarding for the health, treatment and comfort and safety of the patient and personnel. The rule provides standards that address heating, laundry, lighting, emergency lighting, stairways and ramps, storage, ventilation, walls, floors and ceilings. The rule also established standards for water facilities regarding adequacy of supply, sewage disposal, plumbing and the number and location of toilets, handwashing and bathing facilities.
Plan review and fee schedule: The Minnesota Department of Industry and Department of Health provide plan review and inspection services for hospital physical plant state licensure and federal certification requirements. The scope of these responsibilities encompasses both construction of new spaces and modifications to existing spaces. Plan review fees are based on a total of estimated material, labor, and construction costs.
Summary of factual data and analytical methodologies
The department relied on all of the following sources to draft the proposed rule and to determine the impact on small businesses.
- The department solicited comments from representatives of the Wisconsin Hospital Association, Wisconsin Public Psychiatric Hospital, and Wisconsin Healthcare Engineering Association. Representatives from these organizations reviewed the initial draft of the rule.
- 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
TBD, pending an economic impact analysis.
Effect on small business
The rules are anticipated to have little to no economic impact on small businesses.
Agency contact person
Pat Benesh, Division of Quality Assurance, 608-264-9896
