Senate Bill 2628er
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1
2 An act relating to rulemaking authority of the
3 Department of Health (RAB); amending s.
4 154.011, F.S., relating to primary care
5 services; requiring the department to adopt
6 certain rules developed by the State Health
7 Officer; amending s. 154.06, F.S.; requiring
8 the adoption of rules with respect to fees for
9 services rendered through county health
10 departments; amending s. 381.003, F.S.,
11 relating to prevention and control of
12 communicable diseases and acquired immune
13 deficiency syndrome; authorizing rules
14 governing procedures for managing diseases;
15 amending s. 381.004, F.S., relating to testing
16 for human immunodeficiency virus; providing
17 additional rulemaking authority; amending s.
18 381.0051, F.S., relating to family planning
19 services; providing for rules administering the
20 provision of such services; amending s.
21 381.0056, F.S., relating to the school health
22 services program; authorizing the department to
23 adopt rules in cooperation with the Department
24 of Education; amending s. 381.0057, F.S.;
25 providing requirements for the services
26 provided by school health programs; amending s.
27 381.006, F.S., relating to public health;
28 providing additional rulemaking authority;
29 amending s. 381.0062, F.S., relating to the
30 regulation of water systems; providing
31 additional requirements for obtaining an
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1 exemption from the department; amending s.
2 381.0065, F.S.; redefining the term "onsite
3 sewage treatment and disposal system";
4 providing additional rulemaking authority;
5 revising requirements for sewage treatment and
6 disposal systems; amending s. 381.0072, F.S.;
7 requiring the department to adopt additional
8 rules with respect to food service protection;
9 amending s. 381.0086, F.S.; requiring the
10 department to adopt additional rules with
11 respect to the health and safety of migrant
12 farm workers; amending s. 381.0098, F.S.;
13 prohibiting the transfer of a permit for a
14 biomedical waste facility or a biomedical waste
15 transporter; providing requirements for a
16 permit application; amending s. 381.0101, F.S.,
17 relating to environmental health professionals;
18 providing additional rulemaking authority with
19 respect to standards for certification;
20 amending s. 381.0203, F.S.; authorizing the
21 department to adopt rules governing pharmacy
22 services; amending s. 381.89, F.S.; authorizing
23 the department to issue a stop-use order
24 against a tanning facility; amending s.
25 383.011, F.S., relating to maternal and child
26 health programs; providing additional
27 rulemaking authority; amending s. 383.14, F.S.;
28 providing for rules governing screening for
29 metabolic disorders, hereditary disorders, and
30 environmental risk factors; amending s. 383.19,
31 F.S.; providing for rules governing perinatal
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1 intensive care centers; amending s. 383.216,
2 F.S.; revising requirements for prenatal and
3 infant health care coalitions; providing
4 additional rulemaking authority; amending s.
5 384.33, F.S.; authorizing rules governing
6 screenings and investigations to control the
7 spread of sexually transmitted diseases;
8 amending s. 385.207, F.S., relating to care and
9 assistance of persons with epilepsy; providing
10 additional rulemaking authority; amending s.
11 391.026, F.S., relating to the Children's
12 Medical Services Act; requiring the department
13 to adopt rules to administer the act; amending
14 s. 392.66, F.S.; requiring the department to
15 adopt rules to administer the Tuberculosis
16 Control Act; amending ss. 395.401, 395.402,
17 F.S.; requiring the department to adopt rules
18 governing the procedures for establishing a
19 trauma agency and for performance evaluations;
20 requiring the department to establish the
21 number of trauma centers within each service
22 area; amending s. 401.35, F.S.; requiring the
23 department to adopt rules governing medical
24 transportation services; amending s. 403.862,
25 F.S.; authorizing the department to adopt rules
26 governing water systems; amending s. 404.056,
27 F.S., relating to environmental radiation
28 standards and programs; providing additional
29 rulemaking authority; amending s. 404.22, F.S.;
30 authorizing the department to adopt rules
31 governing the operation of radiation machines
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1 and components; amending s. 489.553, F.S.,
2 relating to septic tank contracting; providing
3 additional rulemaking authority; amending ss.
4 491.006, 491.0145, F.S., relating to clinical,
5 counseling, and psychotherapy services;
6 providing for nonrefundable application fees;
7 amending s. 499.003, F.S.; defining the terms
8 "distribute or distribution" for purposes of
9 ch. 499, F.S., relating to the Florida Drug and
10 Cosmetic Act; amending s. 499.005, F.S.;
11 prohibiting charging certain fees or dispensing
12 certain drugs; amending s. 499.0054, F.S.;
13 prohibiting certain labels or advertisements;
14 amending s. 499.01, F.S.; providing additional
15 requirements for closing an establishment
16 permitted under the Florida Drug and Cosmetic
17 Act; amending s. 499.0121, F.S.; providing
18 additional requirements for a vehicle that
19 contains prescription drugs; amending s.
20 499.0122, F.S., relating to medical oxygen and
21 veterinary legend drugs; providing additional
22 rulemaking authority; amending s. 499.013,
23 F.S., relating to manufacturers of drugs,
24 devices, and cosmetics; exempting manufacturers
25 of a device for a specific patient from certain
26 requirements; requiring that manufacturers
27 maintain certain records; amending ss. 499.015,
28 499.024, 499.03, F.S.; providing certain
29 limitations on the registration of products or
30 drugs; conforming cross-references to changes
31 made by the act; amending s. 499.05, F.S.;
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1 requiring the department to adopt additional
2 rules to administer the Florida Drug and
3 Cosmetic Act; amending s. 499.701, F.S.,
4 relating to the regulation of ether; providing
5 additional rulemaking authority; amending s.
6 501.122, F.S.; requiring the department to
7 adopt rules governing radiation surveys;
8 amending s. 513.05, F.S., relating to mobile
9 home and recreational vehicle parks; providing
10 additional rulemaking authority; amending s.
11 514.021, F.S.; authorizing the department to
12 adopt rules governing public swimming and
13 bathing facilities; amending s. 766.1115, F.S.,
14 relating to the Access to Health Care Act;
15 providing for rules governing services and
16 procedures; providing an effective date.
17
18 Be It Enacted by the Legislature of the State of Florida:
19
20 Section 1. Subsection (5) of section 154.011, Florida
21 Statutes, is amended to read:
22 154.011 Primary care services.--
23 (5) The department shall adopt rules to govern the
24 operation of primary care programs authorized by this section.
25 Such rules may shall include, but need not be limited to,
26 requirements for income eligibility, income verification,
27 continuity of care, client services, client enrollment and
28 disenrollment, eligibility, intake, recordkeeping, coverage,
29 quality control, quality of care, case management, and
30 Medicaid participation and shall be developed by the State
31 Health Officer. Rules governing services to clients under 21
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1 years of age shall be developed in conjunction with children's
2 medical services and shall at a minimum include preventive
3 services as set forth in s. 627.6579.
4 Section 2. Subsection (1) of section 154.06, Florida
5 Statutes, is amended to read:
6 154.06 Fees and services rendered; authority.--
7 (1) The Department of Health may is authorized to
8 establish by rule fee schedules for public health services
9 rendered through the county health departments. Such rules may
10 include provisions for fee assessments, copayments, sliding
11 fee scales, fee waivers, and fee exemptions. In addition, the
12 department shall adopt by rule a uniform statewide fee
13 schedule for all regulatory activities performed through the
14 environmental health program. Each county may establish, and
15 each county health department may collect, fees for primary
16 care services, provided that a schedule of such fees is
17 established by resolution of the board of county commissioners
18 or by rule of the department, respectively. Fees for primary
19 care services and communicable disease control services may
20 not be less than Medicaid reimbursement rates unless otherwise
21 required by federal or state law or regulation.
22 Section 3. Subsection (2) of section 381.003, Florida
23 Statutes, is amended to read:
24 381.003 Communicable disease and acquired immune
25 deficiency syndrome prevention and control.--
26 (2) The department may adopt, repeal, and amend rules
27 related to the prevention and control of communicable
28 diseases, including procedures for investigating disease,
29 timeframes for reporting disease, definitions, procedures for
30 managing specific diseases, requirements for followup reports
31 of known or suspected exposure to disease, and procedures for
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1 providing access to confidential information necessary for
2 disease investigations.
3 Section 4. Subsection (10) of section 381.004, Florida
4 Statutes, is amended to read:
5 381.004 Testing for human immunodeficiency virus.--
6 (10) RULES.--The Department of Health may adopt such
7 rules as are necessary to implement this section, including
8 definitions of terms, procedures for accessing confidential
9 information, requirements for testing, and requirements for
10 registered testing sites.
11 Section 5. Subsection (7) of section 381.0051, Florida
12 Statutes, is amended to read:
13 381.0051 Family planning.--
14 (7) RULES.--The Department of Health may adopt rules
15 to implement this section, including rules regarding
16 definitions of terms and requirements for eligibility,
17 informed-consent services, revisits, temporary contraceptive
18 methods, voluntary sterilization, and infertility services.
19 Section 6. Subsection (8) of section 381.0056, Florida
20 Statutes, is amended to read:
21 381.0056 School health services program.--
22 (8) The Department of Health, in cooperation with the
23 Department of Education, may adopt rules necessary to
24 implement this section. The rules may include standards and
25 requirements for developing school health services plans,
26 conducting school health screening, meeting emergency health
27 needs, maintaining school health records, and coordinating
28 with education programs for exceptional students.
29 Section 7. Subsection (7) is added to section
30 381.0057, Florida Statutes, to read:
31 381.0057 Funding for school health services.--
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1 (7) The services provided by a comprehensive school
2 health program must focus attention on promoting the health of
3 students, reducing risk-taking behavior, and reducing teen
4 pregnancy. Services provided under this section are in
5 addition to the services provided under s. 381.0056 and are
6 intended to supplement, rather than supplant, those services.
7 Section 8. Subsection (16) of section 381.006, Florida
8 Statutes, is amended to read:
9 381.006 Environmental health.--The department shall
10 conduct an environmental health program as part of fulfilling
11 the state's public health mission. The purpose of this program
12 is to detect and prevent disease caused by natural and manmade
13 factors in the environment. The environmental health program
14 shall include, but not be limited to:
15 (16) A group-care-facilities function, where a
16 group-care facility means any public or private school,
17 housing, building or buildings, section of a building, or
18 distinct part of a building or other place, whether operated
19 for profit or not, which undertakes, through its ownership or
20 management, to provide one or more personal services, care,
21 protection, and supervision to persons who require such
22 services and who are not related to the owner or
23 administrator. The department may adopt rules necessary to
24 protect the health and safety of residents, staff, and patrons
25 of group-care facilities, such as child care facilities,
26 family day-care homes, assisted-living facilities, adult
27 day-care centers, adult family-care homes, hospices,
28 residential treatment facilities, crisis-stabilization units,
29 pediatric extended-care centers, intermediate-care facilities
30 for the developmentally disabled, group-care homes, and,
31 jointly with the Department of Education, private and public
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1 schools. These rules may include definitions of terms;
2 provisions relating to operation and maintenance of
3 facilities, buildings, grounds, equipment, furnishings, and
4 occupant-space requirements; lighting; heating, cooling, and
5 ventilation; food service; water supply and, plumbing; sewage;
6 sanitary facilities; insect and rodent control; garbage;
7 safety; personnel health, hygiene, and work practices; and
8 other matters the department finds are appropriate or
9 necessary to protect the safety and health of the residents,
10 staff, or patrons. The department may not adopt rules that
11 conflict with rules adopted by the licensing or certifying
12 agency. The department may enter and inspect at reasonable
13 hours to determine compliance with applicable statutes or
14 rules. In addition to any sanctions that the department may
15 impose for violations of rules adopted under this section, the
16 department shall also report such violations to any agency
17 responsible for licensing or certifying the group-care
18 facility. The licensing or certifying agency may also impose
19 any sanction based solely on the findings of the department.
20
21 The department may adopt rules to carry out the provisions of
22 this section.
23 Section 9. Subsection (6) of section 381.0062, Florida
24 Statutes, is amended to read:
25 381.0062 Supervision; private and certain public water
26 systems.--
27 (6) VARIANCES AND EXEMPTIONS.--
28 (a) The department may grant variances and exemptions
29 from the rules adopted promulgated under the provisions of
30 this section through procedures set forth by the rule of the
31 department.
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1 (b) Any establishment with a limited use commercial
2 public water system which does not make tap water available
3 for public consumption and meets the water quality standards
4 and installation requirements established by the department
5 shall be exempt from obtaining an annual operating permit from
6 the department, if the supplier of water:
7 1. Registers with the department; if the establishment
8 changes ownership or business activity, it must register; and
9 pay a $15 registration fee; and
10 2. Performs an initial water quality clearance of the
11 water supply system.
12
13 A system exempt under this subsection may, in order to retain
14 potable water status, conduct annual testing for bacteria in
15 the form of one satisfactory microbiological sample per
16 calendar year.
17 Section 10. Subsections (2), (3), and (4) of section
18 381.0065, Florida Statutes, are amended to read:
19 381.0065 Onsite sewage treatment and disposal systems;
20 regulation.--
21 (2) DEFINITIONS.--As used in ss. 381.0065-381.0067,
22 the term:
23 (a) "Available," as applied to a publicly owned or
24 investor-owned sewerage system, means that the publicly owned
25 or investor-owned sewerage system is capable of being
26 connected to the plumbing of an establishment or residence, is
27 not under a Department of Environmental Protection moratorium,
28 and has adequate permitted capacity to accept the sewage to be
29 generated by the establishment or residence; and:
30 1. For a residential subdivision lot, a single-family
31 residence, or an establishment, any of which has an estimated
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1 sewage flow of 1,000 gallons per day or less, a gravity sewer
2 line to maintain gravity flow from the property's drain to the
3 sewer line, or a low pressure or vacuum sewage collection line
4 in those areas approved for low pressure or vacuum sewage
5 collection, exists in a public easement or right-of-way that
6 abuts the property line of the lot, residence, or
7 establishment.
8 2. For an establishment with an estimated sewage flow
9 exceeding 1,000 gallons per day, a sewer line, force main, or
10 lift station exists in a public easement or right-of-way that
11 abuts the property of the establishment or is within 50 feet
12 of the property line of the establishment as accessed via
13 existing rights-of-way or easements.
14 3. For proposed residential subdivisions with more
15 than 50 lots, for proposed commercial subdivisions with more
16 than 5 lots, and for areas zoned or used for an industrial or
17 manufacturing purpose or its equivalent, a sewerage system
18 exists within one-fourth mile of the development as measured
19 and accessed via existing easements or rights-of-way.
20 4. For repairs or modifications within areas zoned or
21 used for an industrial or manufacturing purpose or its
22 equivalent, a sewerage system exists within 500 feet of an
23 establishment's or residence's sewer stub-out as measured and
24 accessed via existing rights-of-way or easements.
25 (b) "Blackwater" means that part of domestic sewage
26 carried off by toilets, urinals, and kitchen drains.
27 (c) "Domestic sewage" means human body waste and
28 wastewater, including bath and toilet waste, residential
29 laundry waste, residential kitchen waste, and other similar
30 waste from appurtenances at a residence or establishment.
31
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1 (d) "Graywater" means that part of domestic sewage
2 that is not blackwater, including waste from the bath,
3 lavatory, laundry, and sink, except kitchen sink waste.
4 (e) "Florida Keys" means those islands of the state
5 located within the boundaries of Monroe County.
6 (f) "Injection well" means an open vertical hole at
7 least 90 feet in depth, cased and grouted to at least 60 feet
8 in depth which is used to dispose of effluent from an onsite
9 sewage treatment and disposal system.
10 (g) "Innovative system" means an onsite sewage
11 treatment and disposal system that, in whole or in part,
12 employs materials, devices, or techniques that are novel or
13 unique and that have not been successfully field-tested under
14 sound scientific and engineering principles under climatic and
15 soil conditions found in this state.
16 (h) "Lot" means a parcel or tract of land described by
17 reference to recorded plats or by metes and bounds, or the
18 least fractional part of subdivided lands having limited fixed
19 boundaries or an assigned number, letter, or any other legal
20 description by which it can be identified.
21 (i) "Mean annual flood line" means the elevation
22 determined by calculating the arithmetic mean of the
23 elevations of the highest yearly flood stage or discharge for
24 the period of record, to include at least the most recent
25 10-year period. If at least 10 years of data is not available,
26 the mean annual flood line shall be as determined based upon
27 the data available and field verification conducted by a
28 certified professional surveyor and mapper with experience in
29 the determination of flood water elevation lines or, at the
30 option of the applicant, by department personnel. Field
31 verification of the mean annual flood line shall be performed
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1 using a combination of those indicators listed in
2 subparagraphs 1. through 7. that are present on the site, and
3 that reflect flooding that recurs on an annual basis. In those
4 situations where any one or more of these indicators reflect a
5 rare or aberrant event, such indicator or indicators shall not
6 be utilized in determining the mean annual flood line. The
7 indicators that may be considered are:
8 1. Water stains on the ground surface, trees, and
9 other fixed objects;
10 2. Hydric adventitious roots;
11 3. Drift lines;
12 4. Rafted debris;
13 5. Aquatic mosses and liverworts;
14 6. Moss collars; and
15 7. Lichen lines.
16 (j) "Onsite sewage treatment and disposal system"
17 means a system that contains a standard subsurface, filled, or
18 mound drainfield system; an aerobic treatment unit; a
19 graywater system tank; a laundry wastewater system tank; a
20 septic tank; a grease interceptor; a pump dosing tank; a
21 solids or effluent pump; a waterless, incinerating, or organic
22 waste-composting toilet; or a sanitary pit privy that is
23 installed or proposed to be installed beyond the building
24 sewer on land of the owner or on other land to which the owner
25 has the legal right to install a system. The term includes any
26 item placed within, or intended to be used as a part of or in
27 conjunction with, the system. This term does not include
28 package sewage treatment facilities and other treatment works
29 regulated under chapter 403.
30 (k) "Permanent nontidal surface water body" means a
31 perennial stream, a perennial river, an intermittent stream, a
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1 perennial lake, a submerged marsh or swamp, a submerged wooded
2 marsh or swamp, a spring, or a seep, as identified on the most
3 recent quadrangle map, 7.5 minute series (topographic),
4 produced by the United States Geological Survey. "Permanent
5 nontidal surface water body" shall also mean an artificial
6 surface water body that does not have an impermeable bottom
7 and side and that is designed to hold, or does hold, visible
8 standing water for at least 180 days of the year. However, a
9 nontidal surface water body that is drained, either naturally
10 or artificially, where the intent or the result is that such
11 drainage be temporary, shall be considered a permanent
12 nontidal surface water body. A nontidal surface water body
13 that is drained of all visible surface water, where the lawful
14 intent or the result of such drainage is that such drainage
15 will be permanent, shall not be considered a permanent
16 nontidal surface water body. The boundary of a permanent
17 nontidal surface water body shall be the mean annual flood
18 line.
19 (l) "Potable water line" means any water line that is
20 connected to a potable water supply source, but the term does
21 not include an irrigation line with any of the following types
22 of backflow devices:
23 1. For irrigation systems into which chemicals are not
24 injected, any atmospheric or pressure vacuum breaker or double
25 check valve or any detector check assembly.
26 2. For irrigation systems into which chemicals such as
27 fertilizers, pesticides, or herbicides are injected, any
28 reduced pressure backflow preventer.
29 (m) "Septage" means a mixture of sludge, fatty
30 materials, human feces, and wastewater removed during the
31 pumping of an onsite sewage treatment and disposal system.
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1 (n) "Subdivision" means, for residential use, any
2 tract or plot of land divided into two or more lots or parcels
3 of which at least one is 1 acre or less in size for sale,
4 lease, or rent. A subdivision for commercial or industrial
5 use is any tract or plot of land divided into two or more lots
6 or parcels of which at least one is 5 acres or less in size
7 and which is for sale, lease, or rent. A subdivision shall be
8 deemed to be proposed until such time as an application is
9 submitted to the local government for subdivision approval or,
10 in those areas where no local government subdivision approval
11 is required, until such time as a plat of the subdivision is
12 recorded.
13 (o) "Tidally influenced surface water body" means a
14 body of water that is subject to the ebb and flow of the tides
15 and has as its boundary a mean high-water line as defined by
16 s. 177.27(15).
17 (p) "Toxic or hazardous chemical" means a substance
18 that poses a serious danger to human health or the
19 environment.
20 (3) DUTIES AND POWERS OF THE DEPARTMENT OF
21 HEALTH.--The department shall:
22 (a) Adopt rules to administer ss. 381.0065-381.0067,
23 including definitions that are consistent with the definitions
24 in this section, decreases to setback requirements where no
25 health hazard exists, increases for the lot-flow allowance for
26 performance-based systems, requirements for separation from
27 water table elevation during the wettest season, requirements
28 for the design and construction of any component part of an
29 onsite sewage treatment and disposal system, application and
30 permit requirements for persons who maintain an onsite sewage
31 treatment and disposal system, requirements for maintenance
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1 and service agreements for aerobic treatment units and
2 performance-based treatment systems, and recommended
3 standards, including disclosure requirements, for voluntary
4 system inspections to be performed by individuals who are
5 authorized by law to perform such inspections and who shall
6 inform a person having ownership, control, or use of an onsite
7 sewage treatment and disposal system of the inspection
8 standards and of that person's authority to request an
9 inspection based on all or part of the standards.
10 (b) Perform application reviews and site evaluations,
11 issue permits, and conduct inspections and complaint
12 investigations associated with the construction, installation,
13 maintenance, modification, abandonment, operation, use, or
14 repair of an onsite sewage treatment and disposal system for a
15 residence or establishment with an estimated domestic sewage
16 flow of 10,000 gallons or less per day, or an estimated
17 commercial sewage flow of 5,000 gallons or less per day, which
18 is not currently regulated under chapter 403.
19 (c) Develop a comprehensive program to ensure that
20 onsite sewage treatment and disposal systems regulated by the
21 department are sized, designed, constructed, installed,
22 repaired, modified, abandoned, used, operated, and maintained
23 in compliance with this section and rules adopted under this
24 section to prevent groundwater contamination and surface water
25 contamination and to preserve the public health. The
26 department is the final administrative interpretive authority
27 regarding rule interpretation. In the event of a conflict
28 regarding rule interpretation, the Division Director for
29 Environmental Health of the department, or his or her
30 designee, shall timely assign a staff person to resolve the
31 dispute.
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1 (d) Grant variances in hardship cases under the
2 conditions prescribed in this section and rules adopted under
3 this section.
4 (e) Permit the use of a limited number of innovative
5 systems for a specific period of time, when there is
6 compelling evidence that the system will function properly and
7 reliably to meet the requirements of this section and rules
8 adopted under this section.
9 (f) Issue annual operating permits under this section.
10 (g) Establish and collect fees as established under s.
11 381.0066 for services provided with respect to onsite sewage
12 treatment and disposal systems.
13 (h) Conduct enforcement activities, including imposing
14 fines, issuing citations, suspensions, revocations,
15 injunctions, and emergency orders for violations of this
16 section, part I of chapter 386, or part III of chapter 489 or
17 for a violation of any rule adopted under this section, part I
18 of chapter 386, or part III of chapter 489.
19 (i) Provide or conduct education and training of
20 department personnel, service providers, and the public
21 regarding onsite sewage treatment and disposal systems.
22 (j) Supervise research on, demonstration of, and
23 training on the performance, environmental impact, and public
24 health impact of onsite sewage treatment and disposal systems
25 within this state. Research fees collected under s.
26 381.0066(2)(k) must be used to develop and fund hands-on
27 training centers designed to provide practical information
28 about onsite sewage treatment and disposal systems to septic
29 tank contractors, master septic tank contractors, contractors,
30 inspectors, engineers, and the public and must also be used to
31 fund research projects which focus on improvements of onsite
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1 sewage treatment and disposal systems, including use of
2 performance-based standards and reduction of environmental
3 impact. Research projects shall be initially approved by the
4 technical advisory panel and shall be applicable to and
5 reflect the soil conditions specific to Florida. Such
6 projects shall be awarded through competitive negotiation,
7 using the procedures provided in s. 287.055, to public or
8 private entities that have experience in onsite sewage
9 treatment and disposal systems in Florida and that are
10 principally located in Florida. Research projects shall not
11 be awarded to firms or entities that employ or are associated
12 with persons who serve on either the technical advisory panel
13 or the research review and advisory committee.
14 (k) Approve the installation of individual graywater
15 disposal systems in which blackwater is treated by a central
16 sewerage system.
17 (l) Regulate and permit the sanitation, handling,
18 treatment, storage, reuse, and disposal of byproducts from any
19 system regulated under this chapter and septage-stabilization
20 and disposal facilities not regulated by the Department of
21 Environmental Protection.
22 (m) Permit and inspect portable or temporary toilet
23 services and holding tanks. The department shall review
24 applications, perform site evaluations, and issue permits for
25 the temporary use of holding tanks, privies, portable toilet
26 services, or any other toilet facility that is intended for
27 use on a permanent or nonpermanent basis, including facilities
28 placed on construction sites when workers are present. The
29 department may specify standards for the construction,
30 maintenance, use, and operation of any such facility for
31 temporary use.
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1 (4) PERMITS; INSTALLATION; AND CONDITIONS.--A person
2 may not construct, repair, modify, abandon, or operate an
3 onsite sewage treatment and disposal system without first
4 obtaining a permit approved by the department. The department
5 may issue permits to carry out this section, but shall not
6 make the issuance of such permits contingent upon prior
7 approval by the Department of Environmental Protection. A
8 construction permit is valid for 18 months from the issuance
9 date and may be extended by the department for one 90-day
10 period under rules adopted by the department. A repair permit
11 is valid for 90 days from the date of issuance. An operating
12 permit must be obtained prior to the use of any aerobic
13 treatment unit or if the establishment generates commercial
14 waste. Buildings or establishments that use an aerobic
15 treatment unit or generate commercial waste shall be inspected
16 by the department at least annually to assure compliance with
17 the terms of the operating permit. The operating permit is
18 valid for 1 year from the date of issuance and must be renewed
19 annually. If all information pertaining to the siting,
20 location, and installation conditions or repair of an onsite
21 sewage treatment and disposal system remains the same, a
22 construction or repair permit for the onsite sewage treatment
23 and disposal system may be transferred to another person, if
24 the transferee files, within 60 days after the transfer of
25 ownership, an amended application providing all corrected
26 information and proof of ownership of the property. There is
27 no fee associated with the processing of this supplemental
28 information. A person may not contract to construct, modify,
29 alter, repair, service, abandon, or maintain any portion of an
30 onsite sewage treatment and disposal system without being
31 registered under part III of chapter 489. A property owner
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1 who personally performs construction, maintenance, or repairs
2 to a system serving his or her own owner-occupied
3 single-family residence is exempt from registration
4 requirements for performing such construction, maintenance, or
5 repairs on that residence, but is subject to all permitting
6 requirements. A municipality or political subdivision of the
7 state may not issue a building or plumbing permit for any
8 building that requires the use of an onsite sewage treatment
9 and disposal system unless the owner or builder has received a
10 construction permit for such system from the department. A
11 building or structure may not be occupied and a municipality,
12 political subdivision, or any state or federal agency may not
13 authorize occupancy until the department approves the final
14 installation of the onsite sewage treatment and disposal
15 system. A municipality or political subdivision of the state
16 may not approve any change in occupancy or tenancy of a
17 building that uses an onsite sewage treatment and disposal
18 system until the department has reviewed the use of the system
19 with the proposed change, approved the change, and amended the
20 operating permit.
21 (a) Subdivisions and lots in which each lot has a
22 minimum area of at least one-half acre and either a minimum
23 dimension of 100 feet or a mean of at least 100 feet of the
24 side bordering the street and the distance formed by a line
25 parallel to the side bordering the street drawn between the
26 two most distant points of the remainder of the lot may be
27 developed with a water system regulated under s. 381.0062 and
28 onsite sewage treatment and disposal systems, provided the
29 projected daily domestic sewage flow does not exceed an
30 average of 1,500 gallons per acre per day, and provided
31 satisfactory drinking water can be obtained and all distance
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1 and setback, soil condition, water table elevation, and other
2 related requirements of this section and rules adopted under
3 this section can be met.
4 (b) Subdivisions and lots using a public water system
5 as defined in s. 403.852 may use onsite sewage treatment and
6 disposal systems, provided there are no more than four lots
7 per acre, provided the projected daily domestic sewage flow
8 does not exceed an average of 2,500 gallons per acre per day,
9 and provided that all distance and setback, soil condition,
10 water table elevation, and other related requirements that are
11 generally applicable to the use of onsite sewage treatment and
12 disposal systems are met.
13 (c) Notwithstanding the provisions of paragraphs (a)
14 and (b), for subdivisions platted of record on or before
15 October 1, 1991, when a developer or other appropriate entity
16 has previously made or makes provisions, including financial
17 assurances or other commitments, acceptable to the Department
18 of Health, that a central water system will be installed by a
19 regulated public utility based on a density formula, private
20 potable wells may be used with onsite sewage treatment and
21 disposal systems until the agreed-upon densities are reached.
22 The department may consider assurances filed with the
23 Department of Business and Professional Regulation under
24 chapter 498 in determining the adequacy of the financial
25 assurance required by this paragraph. In a subdivision
26 regulated by this paragraph, the average daily domestic sewage
27 flow may not exceed 2,500 gallons per acre per day. This
28 section does not affect the validity of existing prior
29 agreements. After October 1, 1991, the exception provided
30 under this paragraph is not available to a developer or other
31 appropriate entity.
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1 (d) Paragraphs (a) and (b) do not apply to any
2 proposed residential subdivision with more than 50 lots or to
3 any proposed commercial subdivision with more than 5 lots
4 where a publicly owned or investor-owned sewerage system is
5 available. It is the intent of this paragraph not to allow
6 development of additional proposed subdivisions in order to
7 evade the requirements of this paragraph. The department
8 shall report to the Legislature by February 1 of each
9 odd-numbered year concerning the success in meeting this
10 intent.
11 (e) Onsite sewage treatment and disposal systems must
12 not be placed closer than:
13 1. Seventy-five feet from a private potable well.
14 2. Two hundred feet from a public potable well serving
15 a residential or nonresidential establishment having a total
16 sewage flow of greater than 2,000 gallons per day.
17 3. One hundred feet from a public potable well serving
18 a residential or nonresidential establishment having a total
19 sewage flow of less than or equal to 2,000 gallons per day.
20 4. Fifty feet from any nonpotable well.
21 5. Ten feet from any storm sewer pipe, to the maximum
22 extent possible, but in no instance shall the setback be less
23 than 5 feet.
24 6. Seventy-five feet from the mean high-water line of
25 a tidally influenced surface water body;
26 7. Seventy-five feet from the normal annual flood line
27 of a permanent nontidal surface water body;
28 8. Fifteen feet from the design high-water line of
29 retention areas, detention areas, or swales designed to
30 contain standing or flowing water for less than 72 hours after
31 a rainfall or the design high-water level of normally dry
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1 drainage ditches or normally dry individual lot stormwater
2 retention areas.
3 (f) Except as provided under paragraphs (e) and (t),
4 no limitations shall be imposed by rule, relating to the
5 distance between an onsite disposal system and any area that
6 either permanently or temporarily has visible surface water.
7 (g) All provisions of this section and rules adopted
8 under this section relating to soil condition, water table
9 elevation, distance, and other setback requirements must be
10 equally applied to all lots, with the following exceptions:
11 1. Any residential lot that was platted and recorded
12 on or after January 1, 1972, or that is part of a residential
13 subdivision that was approved by the appropriate permitting
14 agency on or after January 1, 1972, and that was eligible for
15 an onsite sewage treatment and disposal system construction
16 permit on the date of such platting and recording or approval
17 shall be eligible for an onsite sewage treatment and disposal
18 system construction permit, regardless of when the application
19 for a permit is made. If rules in effect at the time the
20 permit application is filed cannot be met, residential lots
21 platted and recorded or approved on or after January 1, 1972,
22 shall, to the maximum extent possible, comply with the rules
23 in effect at the time the permit application is filed. At a
24 minimum, however, those residential lots platted and recorded
25 or approved on or after January 1, 1972, but before January 1,
26 1983, shall comply with those rules in effect on January 1,
27 1983, and those residential lots platted and recorded or
28 approved on or after January 1, 1983, shall comply with those
29 rules in effect at the time of such platting and recording or
30 approval. In determining the maximum extent of compliance
31 with current rules that is possible, the department shall
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1 allow structures and appurtenances thereto which were
2 authorized at the time such lots were platted and recorded or
3 approved.
4 2. Lots platted before 1972 are subject to a 50-foot
5 minimum surface water setback and are not subject to lot size
6 requirements. The projected daily flow for domestic onsite
7 sewage treatment and disposal systems for lots platted before
8 1972 may not exceed:
9 a. Two thousand five hundred gallons per acre per day
10 for lots served by public water systems as defined in s.
11 403.852.
12 b. One thousand five hundred gallons per acre per day
13 for lots served by water systems regulated under s. 381.0062.
14 (h)1. The department may grant variances in hardship
15 cases which may be less restrictive than the provisions
16 specified in this section. If a variance is granted and the
17 onsite sewage treatment and disposal system construction
18 permit has been issued, the variance may be transferred with
19 the system construction permit, if the transferee files,
20 within 60 days after the transfer of ownership, an amended
21 construction permit application providing all corrected
22 information and proof of ownership of the property and if the
23 same variance would have been required for the new owner of
24 the property as was originally granted to the original
25 applicant for the variance. There is no fee associated with
26 the processing of this supplemental information. A variance
27 may not be granted under this section until the department is
28 satisfied that:
29 a. The hardship was not caused intentionally by the
30 action of the applicant;
31
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1 b. No reasonable alternative, taking into
2 consideration factors such as cost, exists for the treatment
3 of the sewage; and
4 c. The discharge from the onsite sewage treatment and
5 disposal system will not adversely affect the health of the
6 applicant or the public or significantly degrade the
7 groundwater or surface waters.
8
9 Where soil conditions, water table elevation, and setback
10 provisions are determined by the department to be
11 satisfactory, special consideration must be given to those
12 lots platted before 1972.
13 2. The department shall appoint and staff a variance
14 review and advisory committee, which shall meet monthly to
15 recommend agency action on variance requests. The committee
16 shall make its recommendations on variance requests at the
17 meeting in which the application is scheduled for
18 consideration, except for an extraordinary change in
19 circumstances, the receipt of new information that raises new
20 issues, or when the applicant requests an extension. The
21 committee shall consider the criteria in subparagraph 1. in
22 its recommended agency action on variance requests and shall
23 also strive to allow property owners the full use of their
24 land where possible. The committee consists of the following:
25 a. The Division Director for Environmental Health of
26 the department or his or her designee.
27 b. A representative from the county health
28 departments.
29 c. A representative from the home building industry
30 recommended by the Florida Home Builders Association.
31
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1 d. A representative from the septic tank industry
2 recommended by the Florida Septic Tank Association.
3 e. A representative from the Department of
4 Environmental Protection.
5 f. A representative from the real estate industry who
6 is also a developer in this state who develops lots using
7 onsite sewage treatment and disposal systems, recommended by
8 the Florida Association of Realtors.
9 g. A representative from the engineering profession
10 recommended by the Florida Engineering Society.
11
12 Members shall be appointed for a term of 3 years, with such
13 appointments being staggered so that the terms of no more than
14 two members expire in any one year. Members shall serve
15 without remuneration, but if requested, shall be reimbursed
16 for per diem and travel expenses as provided in s. 112.061.
17 (i) A construction permit may not be issued for an
18 onsite sewage treatment and disposal system in any area zoned
19 or used for industrial or manufacturing purposes, or its
20 equivalent, where a publicly owned or investor-owned sewage
21 treatment system is available, or where a likelihood exists
22 that the system will receive toxic, hazardous, or industrial
23 waste. An existing onsite sewage treatment and disposal
24 system may be repaired if a publicly owned or investor-owned
25 sewerage system is not available within 500 feet of the
26 building sewer stub-out and if system construction and
27 operation standards can be met. This paragraph does not
28 require publicly owned or investor-owned sewerage treatment
29 systems to accept anything other than domestic wastewater.
30 1. A building located in an area zoned or used for
31 industrial or manufacturing purposes, or its equivalent, when
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1 such building is served by an onsite sewage treatment and
2 disposal system, must not be occupied until the owner or
3 tenant has obtained written approval from the department. The
4 department shall not grant approval when the proposed use of
5 the system is to dispose of toxic, hazardous, or industrial
6 wastewater or toxic or hazardous chemicals.
7 2. Each person who owns or operates a business or
8 facility in an area zoned or used for industrial or
9 manufacturing purposes, or its equivalent, or who owns or
10 operates a business that has the potential to generate toxic,
11 hazardous, or industrial wastewater or toxic or hazardous
12 chemicals, and uses an onsite sewage treatment and disposal
13 system that is installed on or after July 5, 1989, must obtain
14 an annual system operating permit from the department. A
15 person who owns or operates a business that uses an onsite
16 sewage treatment and disposal system that was installed and
17 approved before July 5, 1989, need not obtain a system
18 operating permit. However, upon change of ownership or
19 tenancy, the new owner or operator must notify the department
20 of the change, and the new owner or operator must obtain an
21 annual system operating permit, regardless of the date that
22 the system was installed or approved.
23 3. The department shall periodically review and
24 evaluate the continued use of onsite sewage treatment and
25 disposal systems in areas zoned or used for industrial or
26 manufacturing purposes, or its equivalent, and may require the
27 collection and analyses of samples from within and around such
28 systems. If the department finds that toxic or hazardous
29 chemicals or toxic, hazardous, or industrial wastewater have
30 been or are being disposed of through an onsite sewage
31 treatment and disposal system, the department shall initiate
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1 enforcement actions against the owner or tenant to ensure
2 adequate cleanup, treatment, and disposal.
3 (j) An onsite sewage treatment and disposal system for
4 a single-family residence that is designed by a professional
5 engineer registered in the state and certified by such
6 engineer as complying with performance criteria adopted by the
7 department must be approved by the department subject to the
8 following:
9 1. The performance criteria applicable to
10 engineer-designed systems must be limited to those necessary
11 to ensure that such systems do not adversely affect the public
12 health or significantly degrade the groundwater or surface
13 water. Such performance criteria shall include consideration
14 of the quality of system effluent, the proposed total sewage
15 flow per acre, wastewater treatment capabilities of the
16 natural or replaced soil, water quality classification of the
17 potential surface-water-receiving body, and the structural and
18 maintenance viability of the system for the treatment of
19 domestic wastewater. However, performance criteria shall
20 address only the performance of a system and not a system's
21 design.
22 2. The technical review and advisory panel shall
23 assist the department in the development of performance
24 criteria applicable to engineer-designed systems. Workshops
25 on the development of the rules delineating such criteria
26 shall commence not later than September 1, 1996, and the
27 department shall advertise such rules for public hearing no
28 later than October 1, 1997.
29 3. A person electing to utilize an engineer-designed
30 system shall, upon completion of the system design, submit
31 such design, certified by a registered professional engineer,
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1 to the county health department. The county health department
2 may utilize an outside consultant to review the
3 engineer-designed system, with the actual cost of such review
4 to be borne by the applicant. Within 5 working days after
5 receiving an engineer-designed system permit application, the
6 county health department shall request additional information
7 if the application is not complete. Within 15 working days
8 after receiving a complete application for an
9 engineer-designed system, the county health department either
10 shall issue the permit or, if it determines that the system
11 does not comply with the performance criteria, shall notify
12 the applicant of that determination and refer the application
13 to the department for a determination as to whether the system
14 should be approved, disapproved, or approved with
15 modification. The department engineer's determination shall
16 prevail over the action of the county health department. The
17 applicant shall be notified in writing of the department's
18 determination and of the applicant's rights to pursue a
19 variance or seek review under the provisions of chapter 120.
20 4. The owner of an engineer-designed performance-based
21 system must obtain an annual system operating permit from the
22 department. The department shall inspect the system at least
23 annually and may collect system-effluent samples if
24 appropriate to determine compliance with the performance
25 criteria. The fee for the annual operating permit shall be
26 collected beginning with the second year of system operation.
27 5. If an engineer-designed system fails to properly
28 function or fails to meet performance standards, the system
29 shall be re-engineered, if necessary, to bring the system into
30 compliance with the provisions of this section.
31
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1 (k) An innovative system may be approved in
2 conjunction with an engineer-designed site-specific system
3 which is certified by the engineer to meet the
4 performance-based criteria adopted by the department.
5 (l) For the Florida Keys, the department shall adopt a
6 special rule for the construction, installation, modification,
7 operation, repair, maintenance, and performance of onsite
8 sewage treatment and disposal systems which considers the
9 unique soil conditions and which considers water table
10 elevations, densities, and setback requirements. On lots
11 where a setback distance of 75 feet from surface waters,
12 saltmarsh, and buttonwood association habitat areas cannot be
13 met, an injection well, approved and permitted by the
14 department, may be used for disposal of effluent from onsite
15 sewage treatment and disposal systems.
16 (m) No product sold in the state for use in onsite
17 sewage treatment and disposal systems may contain any
18 substance in concentrations or amounts that would interfere
19 with or prevent the successful operation of such system, or
20 that would cause discharges from such systems to violate
21 applicable water quality standards. The department shall
22 publish criteria for products known or expected to meet the
23 conditions of this paragraph. In the event a product does not
24 meet such criteria, such product may be sold if the
25 manufacturer satisfactorily demonstrates to the department
26 that the conditions of this paragraph are met.
27 (n) Evaluations for determining the seasonal
28 high-water table elevations or the suitability of soils for
29 the use of a new onsite sewage treatment and disposal system
30 shall be performed by department personnel, professional
31 engineers registered in the state, or such other persons with
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1 expertise, as defined by rule, in making such evaluations.
2 Evaluations for determining mean annual flood lines shall be
3 performed by those persons identified in paragraph (2)(i). The
4 department shall accept evaluations submitted by professional
5 engineers and such other persons as meet the expertise
6 established by this section or by rule unless the department
7 has a reasonable scientific basis for questioning the accuracy
8 or completeness of the evaluation.
9 (o) The department shall appoint a research review and
10 advisory committee, which shall meet at least semiannually.
11 The committee shall advise the department on directions for
12 new research, review and rank proposals for research
13 contracts, and review draft research reports and make
14 comments. The committee is comprised of:
15 1. A representative of the Division of Environmental
16 Health of the Department of Health.
17 2. A representative from the septic tank industry.
18 3. A representative from the home building industry.
19 4. A representative from an environmental interest
20 group.
21 5. A representative from the State University System,
22 from a department knowledgeable about onsite sewage treatment
23 and disposal systems.
24 6. A professional engineer registered in this state
25 who has work experience in onsite sewage treatment and
26 disposal systems.
27 7. A representative from the real estate profession.
28 8. A representative from the restaurant industry.
29 9. A consumer.
30
31
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1 Members shall be appointed for a term of 3 years, with the
2 appointments being staggered so that the terms of no more than
3 four members expire in any one year. Members shall serve
4 without remuneration, but are entitled to reimbursement for
5 per diem and travel expenses as provided in s. 112.061.
6 (p) An application for an onsite sewage treatment and
7 disposal system permit shall be completed in full, signed by
8 the owner or the owner's authorized representative, or by a
9 contractor licensed under chapter 489, and shall be
10 accompanied by all required exhibits and fees. No specific
11 documentation of property ownership shall be required as a
12 prerequisite to the review of an application or the issuance
13 of a permit. The issuance of a permit does not constitute
14 determination by the department of property ownership.
15 (q) The department may not require any form of
16 subdivision analysis of property by an owner, developer, or
17 subdivider prior to submission of an application for an onsite
18 sewage treatment and disposal system.
19 (r) Nothing in this section limits the power of a
20 municipality or county to enforce other laws for the
21 protection of the public health and safety.
22 (s) In the siting of onsite sewage treatment and
23 disposal systems, including drainfields, shoulders, and
24 slopes, guttering shall not be required on single-family
25 residential dwelling units for systems located greater than 5
26 feet from the roof drip line of the house. If guttering is
27 used on residential dwelling units, the downspouts shall be
28 directed away from the drainfield.
29 (t) Notwithstanding the provisions of subparagraph
30 (f)1., onsite sewage treatment and disposal systems located in
31
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1 floodways of the Suwannee and Aucilla Rivers must adhere to
2 the following requirements:
3 1. The absorption surface of the drainfield shall not
4 be subject to flooding based on 10-year flood elevations.
5 Provided, however, for lots or parcels created by the
6 subdivision of land in accordance with applicable local
7 government regulations prior to January 17, 1990, if an
8 applicant cannot construct a drainfield system with the
9 absorption surface of the drainfield at an elevation equal to
10 or above 10-year flood elevation, the department shall issue a
11 permit for an onsite sewage treatment and disposal system
12 within the 10-year floodplain of rivers, streams, and other
13 bodies of flowing water if all of the following criteria are
14 met:
15 a. The lot is at least one-half acre in size;
16 b. The bottom of the drainfield is at least 36 inches
17 above the 2-year flood elevation; and
18 c. The applicant installs either: a waterless,
19 incinerating, or organic waste composting toilet and a
20 graywater system and drainfield in accordance with department
21 rules; an aerobic treatment unit and drainfield in accordance
22 with department rules; a system approved by the State Health
23 Office that is capable of reducing effluent nitrate by at
24 least 50 percent; or a system approved by the county health
25 department pursuant to department rule other than a system
26 using alternative drainfield materials. The United States
27 Department of Agriculture Soil Conservation Service soil maps,
28 State of Florida Water Management District data, and Federal
29 Emergency Management Agency Flood Insurance maps are resources
30 that shall be used to identify flood-prone areas.
31
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1 2. The use of fill or mounding to elevate a drainfield
2 system out of the 10-year floodplain of rivers, streams, or
3 other bodies of flowing water shall not be permitted if such a
4 system lies within a regulatory floodway of the Suwannee and
5 Aucilla Rivers. In cases where the 10-year flood elevation
6 does not coincide with the boundaries of the regulatory
7 floodway, the regulatory floodway will be considered for the
8 purposes of this subsection to extend at a minimum to the
9 10-year flood elevation.
10 Section 11. Paragraph (a) of subsection (2) of section
11 381.0072, Florida Statutes, is amended to read:
12 381.0072 Food service protection.--It shall be the
13 duty of the Department of Health to adopt and enforce
14 sanitation rules consistent with law to ensure the protection
15 of the public from food-borne illness. These rules shall
16 provide the standards and requirements for the storage,
17 preparation, serving, or display of food in food service
18 establishments as defined in this section and which are not
19 permitted or licensed under chapter 500 or chapter 509.
20 (2) DUTIES.--
21 (a) The department shall adopt rules, including
22 definitions of terms which are consistent with law prescribing
23 minimum sanitation standards and manager certification
24 requirements as prescribed in s. 509.039, and which shall be
25 enforced in food service establishments as defined in this
26 section. The sanitation standards must address the
27 construction, operation, and maintenance of the establishment;
28 lighting, ventilation, laundry rooms, lockers, use and storage
29 of toxic materials and cleaning compounds, and first-aid
30 supplies; plan review; design, construction, installation,
31 location, maintenance, sanitation, and storage of food
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1 equipment and utensils; employee training, health, hygiene,
2 and work practices; food supplies, preparation, storage,
3 transportation, and service, including access to the areas
4 where food is stored or prepared; and sanitary facilities and
5 controls, including water supply and sewage disposal; plumbing
6 and toilet facilities; garbage and refuse collection, storage,
7 and disposal; and vermin control. Public and private schools,
8 hospitals licensed under chapter 395, nursing homes licensed
9 under part II of chapter 400, child care facilities as defined
10 in s. 402.301, and residential facilities colocated with a
11 nursing home or hospital if all food is prepared in a central
12 kitchen that complies with nursing or hospital regulations
13 shall be exempt from the rules developed for manager
14 certification. The department shall administer a comprehensive
15 inspection, monitoring, and sampling program to ensure such
16 standards are maintained. With respect to food service
17 establishments permitted or licensed under chapter 500 or
18 chapter 509, the department shall assist the Division of
19 Hotels and Restaurants of the Department of Business and
20 Professional Regulation and the Department of Agriculture and
21 Consumer Services with rulemaking by providing technical
22 information.
23 Section 12. Subsection (1) of section 381.0086,
24 Florida Statutes, is amended to read:
25 381.0086 Rules; variances; penalties.--
26 (1) The department shall adopt rules necessary to
27 protect the health and safety of migrant farm workers and
28 other migrant labor camp or residential migrant housing
29 occupants, including rules governing field-sanitation
30 facilities. These rules must include definitions of terms,
31 provisions relating to plan review of the construction of new,
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1 expanded, or remodeled camps, sites, buildings and structures,
2 personal hygiene facilities, lighting, sewage disposal,
3 safety, minimum living space per occupant, bedding, food
4 equipment, food storage and preparation, insect and rodent
5 control, garbage, heating equipment, water supply, maintenance
6 and operation of the camp, housing, or roads, and such other
7 matters as the department finds to be appropriate or necessary
8 to protect the life and health of the occupants. Housing
9 operated by a public housing authority is exempt from the
10 provisions of any administrative rule that conflicts with or
11 is more stringent than the federal standards applicable to the
12 housing.
13 Section 13. Subsections (3), (4), and (5) of section
14 381.0098, Florida Statutes, are amended to read:
15 381.0098 Biomedical waste.--
16 (3) OPERATING STANDARDS.--The department shall adopt
17 rules necessary to protect the health, safety, and welfare of
18 the public and to carry out the purpose of this section. Such
19 rules shall address, but need not be limited to, definitions
20 of terms, the packaging of biomedical waste, including
21 specific requirements for the segregation of the waste at the
22 point of generation; the safe packaging of sharps; the
23 placement of the waste in containers that will protect waste
24 handlers and the public from exposure; the appropriate
25 labeling of containers of waste; written operating plans for
26 managing biomedical waste; and the transport, storage, and
27 treatment of biomedical wastes.
28 (4) PERMITS AND FEES.--
29 (a) All persons who generate, store, or treat
30 biomedical waste shall obtain a permit from the department
31 prior to commencing operation, except that a biomedical waste
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1 generator generating less than 25 pounds of biomedical waste
2 in each 30-day period shall be exempt from the registration
3 and fee requirements of this subsection. A biomedical waste
4 generator need not obtain a separate permit if such generator
5 works less than 6 hours in a 7-day period at a location
6 different than the location specified on the permit. The
7 department may issue combined permits for generation, storage,
8 and treatment as appropriate to streamline permitting
9 procedures. Application for such permit shall be made on an
10 application form provided by the department and within the
11 timeframes and in the manner prescribed by department rule.
12 (b) Once the department determines that the person
13 generating, storing, or treating biomedical waste is capable
14 of constructing a facility or operating in compliance with
15 this section and the rules adopted under this section, the
16 department shall grant the permit.
17 (c) If the department determines that the person
18 generating, storing, or treating biomedical waste does not
19 meet the provisions outlined in this section or the rules
20 adopted under this section, the department shall deny the
21 application for the permit pursuant to provisions of chapter
22 120. Such denial shall be in writing and shall list the
23 circumstances for denial. Upon correction of such
24 circumstances the permit shall be issued.
25 (d) The permit for a biomedical waste facility may
26 generator shall not be transferred from one owner to another.
27 When the ownership, control, or name of a biomedical waste
28 facility generator is changed and continues to operate, the
29 new owner shall apply to the department, upon forms provided
30 by the department, for issuance of a permit in the timeframe
31 and manner prescribed by rule of the department.
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1 (e) A permit which the department may require by rule,
2 for the storage or treatment of biomedical waste, may not be
3 transferred by the permittee to any other entity, except in
4 conformity with the requirements of this paragraph.
5 1. Within 30 days after the sale or legal transfer of
6 a permitted facility, the permittee shall file with the
7 department an application for transfer of a permit on such
8 form as the department shall establish by rule. The form must
9 be completed with the notarized signatures of both the
10 transferring permittee and the proposed permittee.
11 2. The department shall approve the transfer of a
12 permit unless it determines that the proposed permittee has
13 not provided reasonable assurances that the proposed permittee
14 has the administrative, technical, and financial capability to
15 properly satisfy the requirements and conditions of the
16 permit, as determined by department rule. The determination
17 shall be limited solely to the ability of the proposed
18 permittee to comply with the conditions of the existing
19 permit, and it shall not concern the adequacy of the permit
20 conditions. If the department proposes to deny the transfer,
21 it shall provide both the transferring permittee and the
22 proposed permittee a written objection to such transfer
23 together with notice of a right to request a proceeding on
24 such determination under chapter 120.
25 3. Within 90 days after receiving a properly completed
26 application for transfer of a permit, the department shall
27 issue a final determination. The department may toll the time
28 for making a determination on the transfer by notifying both
29 the transferring permittee and the proposed permittee that
30 additional information is required to adequately review the
31 transfer request. Such notification shall be provided within
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1 30 days after receipt of an application for transfer of the
2 permit, completed pursuant to this paragraph. If the
3 department fails to take action to approve or deny the
4 transfer within 90 days after receipt of the completed
5 application or within 90 days after receipt of the last item
6 of timely requested additional information, the transfer shall
7 be deemed approved.
8 4. The transferring permittee is encouraged to apply
9 for a permit transfer well in advance of the sale or legal
10 transfer of a permitted facility. However, the transfer of
11 the permit shall not be effective prior to the sale or legal
12 transfer of the facility.
13 5. Until the transfer of the permit is approved by the
14 department, the transferring permittee and any other person
15 constructing, operating, or maintaining the permitted facility
16 shall be liable for compliance with the terms of the permit.
17 Nothing in this section shall relieve the transferring
18 permittee of liability for corrective actions that may be
19 required as a result of any violations occurring prior to the
20 legal transfer of the permit.
21 (e)(f) The department shall establish a schedule of
22 fees for such permits. Fees assessed under this section shall
23 be in an amount sufficient to meet the costs of carrying out
24 the provisions of this section and rules adopted under this
25 section. The fee schedule shall not be less than $50 or more
26 than $400 for each year the permit is valid. Fees may be
27 prorated on a quarterly basis when a facility will be in
28 operation for 6 months or less before the annual renewal date.
29 The department shall assess the minimum fees provided in this
30 subsection until a fee schedule is adopted promulgated by rule
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1 of the department. Facilities owned and operated by the state
2 shall be exempt from the payment of any fees.
3 (f)(g) Fees collected by the department in accordance
4 with provisions of this section and the rules adopted under
5 this section shall be deposited into a trust fund administered
6 by the department for the payment of costs incurred in the
7 administration of this section.
8 (g)(h) Permits issued by the department shall be valid
9 for no more than 5 years. However, upon expiration, a new
10 permit may be issued by the department in accordance with this
11 section and the rules of the department.
12 (h)(i) The department may is authorized to develop a
13 streamlined process for permitting biomedical waste storage
14 facilities that accept and store only sharps collected from
15 the public, which may include the issuance of a single permit
16 for each applicant that which develops or sponsors a sharps
17 collection program.
18 (5) TRANSPORTERS.--Any person who transports
19 biomedical waste within the state must register with the
20 department prior to engaging in the transport of biomedical
21 waste in accordance with rules adopted promulgated by the
22 department. A registration may not be transferred from one
23 biomedical waste transporter to another. If the ownership or
24 name of a biomedical waste transporter is changed and the
25 owner intends to continue operation of the transporter, the
26 owner must apply to the department on departmental forms
27 within the timeframes and in the manner prescribed by
28 department rule. The department may charge registration fees
29 in the same manner as is provided in paragraphs (4)(e) and (f)
30 (4)(f) and (g). The department may exempt from this
31
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1 requirement any person who, or facility that, transports less
2 than 25 pounds of such waste on any single occasion.
3 Section 14. Subsection (5) of section 381.0101,
4 Florida Statutes, is amended to read:
5 381.0101 Environmental health professionals.--
6 (5) STANDARDS FOR CERTIFICATION.--The department shall
7 adopt rules that establish definitions of terms and minimum
8 standards of education, training, or experience for those
9 persons subject to this section. The rules must shall also
10 address the process for application, examination, issuance,
11 expiration, and renewal of certification and ethical standards
12 of practice for the profession.
13 (a) Persons employed as environmental health
14 professionals shall exhibit a knowledge of rules and
15 principles of environmental and public health law in Florida
16 through examination. A person may not conduct environmental
17 health evaluations in a primary program area unless he or she
18 is currently certified in that program area or works under the
19 direct supervision of a certified environmental health
20 professional.
21 1. All persons who begin employment in a primary
22 environmental health program on or after September 21, 1994,
23 must be certified in that program within 6 months after
24 employment.
25 2. Persons employed in a primary environmental health
26 program prior to September 21, 1994, shall be considered
27 certified while employed in that position and shall be
28 required to adhere to any professional standards established
29 by the department pursuant to paragraph (b), complete any
30 continuing education requirements imposed under paragraph (d),
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1 and pay the certificate renewal fee imposed under subsection
2 (7).
3 3. Persons employed in a primary environmental health
4 program prior to September 21, 1994, who change positions or
5 program areas and transfer into another primary environmental
6 health program area on or after September 21, 1994, must be
7 certified in that program within 6 months after such transfer,
8 except that they will not be required to possess the college
9 degree required under paragraph (e).
10 4. Registered sanitarians shall be considered
11 certified and shall be required to adhere to any professional
12 standards established by the department pursuant to paragraph
13 (b).
14 (b) At a minimum, the department shall establish
15 standards for professionals in the areas of food hygiene and
16 onsite sewage treatment and disposal.
17 (c) Those persons conducting primary environmental
18 health evaluations shall be certified by examination to be
19 knowledgeable in any primary area of environmental health in
20 which they are routinely assigned duties.
21 (d) Persons who are certified shall renew their
22 certification biennially by completing not less than 24
23 contact hours of continuing education for each program area in
24 which they maintain certification.
25 (e) Applicants for certification shall have graduated
26 from an accredited 4-year college or university with a degree
27 or major coursework in public health, environmental health,
28 environmental science, or a physical or biological science.
29 (f) A certificateholder shall notify the department
30 within 60 days after any change of name or address from that
31 which appears on the current certificate.
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1 Section 15. Subsection (1) of section 381.0203,
2 Florida Statutes, is amended to read:
3 381.0203 Pharmacy services.--
4 (1) The department may contract on a statewide basis
5 for the purchase of drugs, as defined in s. 499.003, to be
6 used by state agencies and political subdivisions, and may
7 adopt rules to administer this section.
8 Section 16. Subsections (12) and (13) of section
9 381.89, Florida Statutes, are amended to read:
10 381.89 Regulation of tanning facilities.--
11 (12) The department may institute legal action for
12 injunctive or other relief to enforce this section. If a
13 tanning facility or other person violates this section or any
14 rule adopted under this section, the department may issue a
15 stop-use order, as prescribed by rule, to remove a tanning
16 device from service.
17 (13) The department shall adopt rules to administer
18 implement this section. The rules may include, but need not be
19 limited to, requirements for training tanning facility
20 operators and employees; definitions of terms; the approval of
21 training courses; safety; plan review; and the design,
22 construction, operation, maintenance, and cleanliness of
23 tanning facilities and tanning devices.
24 Section 17. Paragraph (a) of subsection (2) of section
25 383.011, Florida Statutes, is amended to read:
26 383.011 Administration of maternal and child health
27 programs.--
28 (2) The Department of Health shall follow federal
29 requirements and may adopt any rules necessary for the
30 implementation of the maternal and child health care program,
31 the WIC program, and the Child Care Food Program.
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1 (a) The department may adopt rules that are necessary
2 to administer the maternal and child health care program. The
3 rules may include, but need not be limited to, requirements
4 for client eligibility, program standards, service delivery,
5 system responsibilities of county health departments and
6 system assurance for healthy start coalitions, care
7 coordination, enhanced services, quality assurance, and
8 provider selection. The rules may also include provisions for
9 the identification, screening, and intervention efforts by
10 health care providers prior to and following the birth of a
11 child and responsibilities for the interprogram coordination
12 of prenatal and infant care coalitions.
13 Section 18. Subsection (2) of section 383.14, Florida
14 Statutes, is amended to read:
15 383.14 Screening for metabolic disorders, other
16 hereditary and congenital disorders, and environmental risk
17 factors.--
18 (2) RULES.--After consultation with the Genetics and
19 Infant Screening Advisory Council, the department shall adopt
20 and enforce rules requiring that every infant born in this
21 state shall, prior to becoming 2 weeks of age, be subjected to
22 a test for phenylketonuria and, at the appropriate age, be
23 tested for such other metabolic diseases and hereditary or
24 congenital disorders as the department may deem necessary from
25 time to time. After consultation with the State Coordinating
26 Council for Early Childhood Services, the department shall
27 also adopt and enforce rules requiring every infant born in
28 this state to be screened for environmental risk factors that
29 place children and their families at risk for increased
30 morbidity, mortality, and other negative outcomes. The
31 department shall adopt such additional rules as are found
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1 necessary for the administration of this section, including
2 rules providing definitions of terms, rules relating to the
3 methods used and time or times for testing as accepted medical
4 practice indicates, rules relating to charging and collecting
5 fees for screenings authorized by this section, and rules
6 requiring mandatory reporting of the results of tests and
7 screenings for these conditions to the department.
8 Section 19. Subsection (1) of section 383.19, Florida
9 Statutes, is amended to read:
10 383.19 Standards; funding; ineligibility.--
11 (1) The department shall adopt rules that specify
12 standards for development and operation of a center which
13 include, but are not limited to:
14 (a) The need to provide services through a regional
15 perinatal intensive care center and the requirements of the
16 population to be served.
17 (b) Equipment.
18 (c) Facilities.
19 (d) Staffing and qualifications of personnel.
20 (e) Transportation services.
21 (f) Data collection.
22 (g) Definitions of terms.
23 Section 20. Subsections (9) and (10) of section
24 383.216, Florida Statutes, are amended to read:
25 383.216 Community-based prenatal and infant health
26 care.--
27 (9) Local prenatal and infant health care coalitions
28 shall incorporate as not-for-profit corporations for the
29 purpose of seeking and receiving grants from federal, state,
30 and local government and other contributors. However, a
31
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1 coalition need not be designated as a tax-exempt organization
2 under s. 501(c)(3) of the Internal Revenue Code.
3 (10) The Department of Health shall adopt rules as
4 necessary to administer implement this section, including
5 rules defining acceptable "in-kind" contributions and rules
6 providing definitions of terms, coalition responsibilities,
7 coalition operations and standards, and conditions for
8 establishing and approving a coalition. A coalition may not be
9 a direct provider of prenatal and infant-care services.
10 Section 21. Section 384.33, Florida Statutes, is
11 amended to read:
12 384.33 Rules.--The department may adopt rules pursuant
13 to ss. 120.536(1) and 120.54 to implement the provisions of
14 this chapter. The rules may include requirements for methods
15 of contacting a physician to determine the need for followup
16 services related to sexually transmissible diseases; standards
17 for screening, treating, and performing contact investigations
18 to control the spread of sexually transmitted diseases; and
19 requirements for maintaining the security of confidential
20 information.
21 Section 22. Subsection (4) of section 385.207, Florida
22 Statutes, is amended to read:
23 385.207 Care and assistance of persons with epilepsy;
24 establishment of programs in epilepsy control.--
25 (4) The department shall adopt rules to administer
26 implement this section. The rules may include requirements for
27 the scope of service, criteria for eligibility, and
28 requirements for reports and forms.
29 Section 23. Subsection (18) of section 391.026,
30 Florida Statutes, is amended to read:
31
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1 391.026 Powers and duties of the department.--The
2 department shall have the following powers, duties, and
3 responsibilities:
4 (18) To adopt rules pursuant to ss. 120.536(1) and
5 120.54 to administer implement the Children's Medical Services
6 provisions of this Act. The rules may include requirements for
7 definitions of terms, program organization, and program
8 description; a process for selecting an area medical director;
9 responsibilities of applicants and clients; requirements for
10 service applications, including required medical and financial
11 information; eligibility requirements for initial treatment
12 and for continued eligibility, including financial and custody
13 issues; methodologies for resource development and allocation,
14 including medical and financial considerations; requirements
15 for reimbursement services rendered to a client; billing and
16 payment requirements for providers; requirements for
17 qualification, appointments, verification, and emergency
18 exceptions for health-professional consultants; general and
19 diagnostic-specific standards for diagnostic and treatment
20 facilities; and standards for the method of service delivery,
21 including consultant services, respect-for-privacy
22 considerations, examination requirements, family support
23 plans, and clinic design.
24 Section 24. Section 392.66, Florida Statutes, is
25 amended to read:
26 392.66 Rules.--The department shall adopt rules
27 pursuant to ss. 120.536(1) and 120.54 to administer implement
28 the provisions of this chapter. The rules must include
29 requirements for tuberculosis treatment and provide
30 consequences if a person who has active tuberculosis fails to
31 comply with treatment requirements.
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1 Section 25. Subsection (2) of section 395.401, Florida
2 Statutes, is amended to read:
3 395.401 Trauma services system plans; verification of
4 trauma centers and pediatric trauma referral centers;
5 procedures; renewal.--
6 (2)(a) The local and regional trauma agencies shall
7 plan, implement, and evaluate trauma services systems, in
8 accordance with this section and ss. 395.4015, 395.404, and
9 395.4045, which consist of organized patterns of readiness and
10 response services based on public and private agreements and
11 operational procedures. The department shall establish, by
12 rule, processes and procedures for establishing a trauma
13 agency and obtaining its approval from the department.
14 (b) The local and regional trauma agencies shall
15 develop and submit to the department plans for local and
16 regional trauma services systems. The plans must include, at a
17 minimum, the following components:
18 1. The organizational structure of the trauma system.
19 2. Prehospital care management guidelines for triage
20 and transportation of trauma cases.
21 3. Flow patterns of trauma cases and transportation
22 system design and resources, including air transportation
23 services, and provision for interfacility transfer.
24 4. The number and location of needed state-approved
25 trauma centers based on local needs, population, and location
26 and distribution of resources.
27 5. Data collection regarding system operation and
28 patient outcome.
29 6. Periodic performance evaluation of the trauma
30 system and its components.
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1 7. The use of air transport services within the
2 jurisdiction of the local trauma agency.
3 8. Public information and education about the trauma
4 system.
5 9. Emergency medical services communication system
6 usage and dispatching.
7 10. The coordination and integration between the
8 verified trauma care facility and the nonverified health care
9 facilities.
10 11. Medical control and accountability.
11 12. Quality control and system evaluation.
12 (c) The department shall receive plans for the
13 implementation of inclusive trauma systems from trauma
14 agencies. The department may approve or not approve trauma
15 agency plans based on the conformance of the plan with this
16 section and ss. 395.4015, 395.404, and 395.4045 and the rules
17 and definitions adopted by the department pursuant to those
18 sections. The department shall approve or disapprove the
19 plans within 120 days after the date the plans are submitted
20 to the department. The department shall, by rule, provide an
21 application process for establishing a trauma agency. The
22 application must, at a minimum, provide requirements for the
23 trauma agency plan submitted for review, a process for
24 reviewing the application for a state-approved trauma agency,
25 a process for reviewing the trauma transport protocols for the
26 trauma agency, and a process for reviewing the staffing
27 requirements for the agency. The department shall, by rule,
28 establish minimum requirements for a trauma agency to conduct
29 an annual performance evaluation and submit the results to the
30 department.
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1 (d) A trauma agency shall not operate unless the
2 department has approved the local or regional trauma services
3 system plan of the agency.
4 (e) The department may grant an exception to a portion
5 of the rules adopted pursuant to this section or s. 395.4015
6 if the local or regional trauma agency proves that, as defined
7 in the rules, compliance with that requirement would not be in
8 the best interest of the persons served within the affected
9 local or regional trauma area.
10 (f) A local or regional trauma agency may implement a
11 trauma care system only if the system meets the minimum
12 standards set forth in the rules for implementation
13 established by the department and if the plan has been
14 submitted to, and approved by, the department. At least 60
15 days before the local or regional trauma agency submits the
16 plan for the trauma care system to the department, the local
17 or regional trauma agency shall hold a public hearing and give
18 adequate notice of the public hearing to all hospitals and
19 other interested parties in the area to be included in the
20 proposed system.
21 (g) Local or regional trauma agencies may enter into
22 contracts for the purpose of implementing the local or
23 regional plan. If local or regional agencies contract with
24 hospitals for trauma services, such agencies must contract
25 only with hospitals which are verified trauma centers.
26 (h) Local or regional trauma agencies providing
27 service for more than one county shall, as part of their
28 formation, establish interlocal agreements between or among
29 the several counties in the regional system.
30
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1 (i) This section does not restrict the authority of a
2 health care facility to provide service for which it has
3 received a license pursuant to this chapter.
4 (j) Any hospital which is verified as a trauma center
5 shall accept all trauma victims that are appropriate for the
6 facility regardless of race, sex, creed, or ability to pay.
7 (k) It is unlawful for any hospital or other facility
8 to hold itself out as a trauma center unless it has been so
9 verified.
10 (l) A county, upon the recommendations of the local or
11 regional trauma agency, may adopt ordinances governing the
12 transport of a patient who is receiving care in the field from
13 prehospital emergency medical personnel when the patient meets
14 specific criteria for trauma, burn, or pediatric centers
15 adopted by the local or regional trauma agency. These
16 ordinances must be consistent with s. 395.4045, ordinances
17 adopted under s. 401.25(6), and the local or regional trauma
18 system plan and, to the furthest possible extent, must ensure
19 that individual patients receive appropriate medical care
20 while protecting the interests of the community at large by
21 making maximum use of available emergency medical care
22 resources.
23 (m) The local or regional trauma agency shall,
24 consistent with the regional trauma system plan, coordinate
25 and otherwise facilitate arrangements necessary to develop a
26 trauma services system.
27 (n) After the submission of the initial trauma system
28 plan, each trauma agency shall, every 5th year, submit to the
29 department for approval an updated plan that identifies the
30 changes, if any, to be made in the regional trauma system.
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1 (o) This section does not preclude a local or regional
2 trauma agency from adopting trauma care system standards.
3 Section 26. Paragraph (b) of subsection (3) of section
4 395.402, Florida Statutes, is amended to read:
5 395.402 Trauma service areas; number and location of
6 trauma centers.--
7 (3) Trauma service areas are to be used. The
8 department shall periodically review the assignment of the 67
9 counties to trauma service areas. These assignments are made
10 for the purpose of developing a system of trauma centers.
11 Revisions made by the department should take into
12 consideration the recommendations made as part of the regional
13 trauma system plans approved by the department, as well as the
14 recommendations made as part of the state trauma system plan.
15 These areas must, at a minimum, be reviewed in the year 2000
16 and every 5 years thereafter. Until the department completes
17 its initial review, the assignment of counties shall remain as
18 established pursuant to chapter 90-284, Laws of Florida.
19 (b) Each trauma service area should have at least one
20 Level I or Level II trauma center. The department shall
21 allocate, by rule, the number of trauma centers needed for
22 each trauma service area.
23 Section 27. Section 401.35, Florida Statutes, is
24 amended to read:
25 401.35 Rules.--The department shall adopt rules,
26 including definitions of terms, necessary to carry out the
27 purposes of this part.
28 (1) The rules must provide at least minimum standards
29 governing:
30 (a) Sanitation, safety, and maintenance of basic life
31 support and advanced life support vehicles and air ambulances.
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1 (b) Emergency medical technician, paramedic, and
2 driver training and qualifications.
3 (c) Ground ambulance and vehicle equipment and
4 supplies at least as comprehensive as those published in the
5 most current edition of the American College of Surgeons,
6 Committee on Trauma, list of essential equipment for
7 ambulances, as interpreted by rules of the department.
8 (d) Ground ambulance or vehicle design and
9 construction at least equal to those most currently
10 recommended by the United States General Services
11 Administration as interpreted by rules of the department.
12 (e) Staffing of basic life support and advanced life
13 support vehicles.
14 (f) Two-way communications for basic life support
15 services and advanced life support services.
16 (g) Advanced life support services equipment.
17 (h) Programs of training for emergency medical
18 technicians and paramedics.
19 (i) Vehicles, equipment, communications, and minimum
20 staffing qualifications for air ambulance services.
21 (j) Ambulance driver qualifications, training, and
22 experience.
23 (k) Optional use of telemetry by licensees.
24 (l) Licensees' security and storage of controlled
25 substances, medications, and fluids, not inconsistent with the
26 provisions of chapter 499 or chapter 893.
27 (2) The rules must establish application requirements
28 for licensure and certification. Pursuant thereto, the
29 department must develop application forms for basic life
30 support services and advanced life support services. An
31
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1 application for each respective service license must include,
2 but is not limited to:
3 (a) The name and business address of the operator and
4 owner of the service or proposed service.
5 (b) The name under which the applicant will operate.
6 (c) A list of the names and addresses of all officers,
7 directors, and shareholders of the applicant.
8 (d) A description of each vehicle to be used,
9 including the make, model, year of manufacture, mileage, and
10 vehicle identification number (VIN); the state or federal
11 aviation or marine registration number, when applicable; and
12 the color scheme, insignia, name, monogram, or other
13 distinguishing characteristics to be used to designate the
14 applicant's vehicle or vehicles.
15 (e) The service location from which the service will
16 operate.
17 (f) A statement reasonably describing the geographic
18 area or areas to be served by the applicant.
19 (g) A statement certifying that the applicant will
20 provide continuous service 24 hours a day, 7 days a week, if a
21 basic life support service license or an advanced life support
22 service license is sought. Such service must be initiated
23 within 30 days after issuance of the license.
24 (h) Such other information as the department
25 determines reasonable and necessary.
26 (i) An oath, upon forms provided by the department
27 which shall contain such information as the department
28 reasonably requires, which may include affirmative evidence of
29 ability to comply with applicable laws and rules.
30 (3) The rules must establish specifications regarding
31 insignia and other ambulance identification. Any fire
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1 department may retain its fire department identity and may use
2 such color scheme, insignia, name, monogram, or other
3 distinguishing characteristic that is acceptable to the fire
4 department for the purpose of designating its vehicles as
5 advanced life support vehicles. However, those advanced life
6 support service/fire rescue vehicles or ambulances operated by
7 fire departments which were purchased in whole or in part with
8 federal funds must comply with federal regulations pertaining
9 to color schemes, emblems, and markings.
10 (4) The rules must establish circumstances and
11 procedures under which emergency medical technicians and
12 paramedics may honor orders by the patient's physician not to
13 resuscitate and the documentation and reporting requirements
14 for handling such requests.
15 (5) The rules must establish requirements for
16 licensees and certificateholders with respect to providing
17 address information to the department; requirements for
18 examinations, grading, and passing scores for certification;
19 and requirements for determining whether a convicted felon
20 whose civil rights have not been restored is eligible for
21 certification or recertification.
22 Section 28. Paragraph (f) of subsection (1) of section
23 403.862, Florida Statutes, is amended to read:
24 403.862 Department of Health; public water supply
25 duties and responsibilities; coordinated budget requests with
26 department.--
27 (1) Recognizing that supervision and control of county
28 health departments of the Department of Health is retained by
29 the secretary of that agency, and that public health aspects
30 of the state public water supply program require joint
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1 participation in the program by the Department of Health and
2 its units and the department, the Department of Health shall:
3 (f) Have general supervision and control over all
4 private water systems and all public water systems not
5 otherwise covered or included in this part. This shall include
6 the authority to adopt and enforce rules, including
7 definitions of terms, to protect the health, safety, or
8 welfare of persons being served by all private water systems
9 and all public water systems not otherwise covered by this
10 part.
11 Section 29. Subsection (3) of section 404.056, Florida
12 Statutes, is amended to read:
13 404.056 Environmental radiation standards and
14 programs; radon protection.--
15 (3) CERTIFICATION.--
16 (a) The department may is authorized to certify
17 persons who perform radon gas or radon progeny measurements,
18 including sample collection, analysis, or interpretation of
19 such measurements, and who perform mitigation of buildings for
20 radon gas or radon progeny, and shall collect a fee for such
21 certification. Before performing radon measurement or radon
22 mitigation services, including collecting samples, performing
23 analysis, or interpreting measurement results, a certified
24 individual must own, be employed by, or be retained as a
25 consultant to a certified radon measurement or certified radon
26 mitigation business. The department may establish criteria for
27 the application, certification, and annual renewal of basic
28 and advanced levels of certification for individuals, which
29 may include requirements for education and experience,
30 approved training, examinations, and reporting. The department
31 may approve training courses for certification and establish
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1 criteria for training courses and instructors. The department
2 may observe and evaluate training sessions, instructors, and
3 course material without charge.
4 (b) A person may not participate in performing radon
5 gas or radon progeny measurements, including sample
6 collection, analysis, or interpretation of such measurements,
7 or perform mitigation of buildings for radon gas or radon
8 progeny, and charge a fee or obtain other remuneration as
9 benefit for such services or devices, unless that person is
10 certified by the department. A certification issued in
11 accordance with this section automatically expires at the end
12 of the certification period stated on the certificate. An
13 uncertified commercial business may subcontract radon
14 measurements to a certified radon business. The uncertified
15 commercial business must provide the complete radon report
16 from the certified radon business to the client and direct all
17 the client's questions about the measurements or radon report
18 to the certified radon business.
19 (c) The results of measurements of radon gas or radon
20 progeny performed by persons certified under the provisions of
21 this subsection shall be reported to the department and
22 persons contracting for the service. Upon request, the
23 results of measurements of radon gas or radon progeny which
24 are performed to evaluate the effectiveness of a radon
25 mitigation system shall be reported to the certified business
26 that installed the mitigation system. The report must include
27 the radon levels detected; the location, age, and description
28 of the building; the name and certification numbers of the
29 certified radon measurement business and individual who
30 performed the measurements; and other information determined
31 by the department to meet the requirements of the protocols
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1 and procedures for the type of measurement performed. Each
2 installation of a radon mitigation system performed by a
3 person certified under this section must be reported to the
4 department according to the schedule set by the department.
5 The report must include the premitigation and postmitigation
6 radon levels; the type or types of systems installed; the
7 location, age, and description of the building; and the name
8 and certification number of the certified mitigation business
9 that performed the mitigation.
10 (d) Authorized representatives of the department may
11 have the authority to inspect the business and records of any
12 person certified under the provisions of this subsection, at
13 all reasonable times, to examine records and test procedures
14 to determine compliance with or violation of the provisions of
15 this section.
16 (e) Any person who practices fraud, deception, or
17 misrepresentation in performing radon gas or radon progeny
18 measurements or in performing mitigation of buildings for
19 radon gas or radon progeny is subject to the penalties
20 provided in s. 404.161.
21 (f) The department may is authorized to charge and
22 collect nonrefundable fees for the certification and annual
23 recertification of persons who perform radon gas or radon
24 progeny measurements or who perform mitigation of buildings
25 for radon gas or radon progeny. The amount of the initial
26 application fee and certification shall be not less than $200
27 or more than $900. The amount of the annual recertification
28 fee shall be not less than $200 or more than $900. Effective
29 July 1, 1988, the fee amounts shall be the minimum fee
30 prescribed in this paragraph, and such fee amounts shall
31 remain in effect until the effective date of a fee schedule
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1 promulgated by rule by the department. The fees collected
2 shall be deposited in the Radiation Protection Trust Fund and
3 shall be used only to implement the provisions of this
4 section. The surcharge established pursuant to subsection (3)
5 may be used to supplement the fees established in this
6 paragraph in carrying out the provisions of this subsection.
7 (g) The department may establish enforcement
8 procedures; deny an application for initial or renewal
9 certification; deny, suspend, or revoke a certification;, or
10 impose an administrative fine not to exceed $1,000 per
11 violation per day, for the violation of any provision of this
12 section or rule adopted under this section promulgated
13 pursuant thereto.
14 (h) A certificateholder in good standing remains in
15 good standing when he or she becomes a member of the Armed
16 Forces of the United States on active duty without payment of
17 renewal fees as long as he or she is a member of the Armed
18 Forces on active duty and for a period of 6 months after his
19 or her discharge from active duty, if he or she is not engaged
20 in practicing radon measurement or radon mitigation in the
21 private sector for profit. The certificateholder must pay a
22 renewal fee to renew the certificate.
23 (i) A certificateholder who is in good standing
24 remains in good standing if he or she is absent from the state
25 because of his or her spouse's active duty with the Armed
26 Forces of the United States. The certificateholder remains in
27 good standing without payment of renewal fees as long as his
28 or her spouse is a member of the Armed Forces on active duty
29 and for a period of 6 months after the spouse's discharge from
30 active duty, if the certificateholder is not engaged in
31 practicing radon measurement or radon mitigation in the
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1 private sector for profit. The certificateholder must pay a
2 renewal fee to renew the certificate.
3 (j) The department may set criteria and requirements
4 for the application, certification, and annual renewal of
5 certification for radon measurement and mitigation businesses,
6 which may include:
7 1. Requirements for measurement devices and
8 measurement procedures, including the disclosure of mitigation
9 materials, systems, and other mitigation services offered.
10 2. The identification of certified specialists and
11 technicians employed by the business and requirements for
12 specialist staffing and duties.
13 3. The analysis of measurement devices by proficient
14 analytical service providers.
15 4. Requirements for a quality assurance and quality
16 control program.
17 5. The disclosure of client measurement reporting
18 forms and warranties and operating instructions for mitigation
19 systems.
20 6. Requirements for radon services publications and
21 the identification of the radon business certification number
22 in advertisements.
23 7. Requirements for a worker health and safety
24 program.
25 8. Requirements for maintaining radon records.
26 9. The operation of branch office locations.
27 10. Requirements for supervising subcontractors who
28 install mitigation systems.
29 11. Requirements for building inspections and
30 evaluation and standards for the design and installation of
31 mitigation systems.
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1 12. Prescribing conditions of premitigation and
2 postmitigation mitigation measurements.
3 13. Requirements for renewals received after the
4 automatic expiration date of certification.
5 14. Requirements for obtaining a duplicate or
6 replacement certificate, including a fee not to exceed the
7 cost of producing the duplicate or replacement certificate.
8 15. Requirements for reporting, including timeframes
9 and content.
10 (k) Any change in the information provided to the
11 department in the original business application to be reported
12 within 10 days after the change.
13 Section 30. Subsection (1) of section 404.22, Florida
14 Statutes, is amended to read:
15 404.22 Radiation machines and components;
16 inspection.--
17 (1) The department and its duly authorized agents may
18 inspect in a lawful manner at all reasonable hours any
19 hospital or other health care facility or other place in the
20 state in which a radiation machine is installed for the
21 purpose of determining whether the facility, the radiation
22 machine and its components, the film and film processing
23 equipment, the techniques and procedures, any mechanical
24 holding devices, the warning labels and signs, the written
25 safety procedures, and the resultant image produced meet the
26 standards of the department as set forth in this chapter and
27 rules adopted pursuant to this chapter thereto. Such rules may
28 include standards for radiation machine performance, surveys,
29 calibrations, and spot checks; requirements for quality
30 assurance programs and quality control programs; standards for
31 facility electrical systems, safety alarms,
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1 radiation-monitoring equipment, and dosimetry systems;
2 requirements for visual and aural communication with patients;
3 procedures for establishing radiation-safety committees for a
4 facility; and qualifications of persons who cause a radiation
5 machine to be used, who operate a radiation machine, and who
6 ensure that a radiation machine complies with the requirements
7 of this chapter and with rules of the department. If, in the
8 opinion of the department, a radiation machine that which
9 fails to meet such standards can be made to meet the standards
10 through an adjustment or limitation upon the stations or range
11 of the radiation machine or through the purchase of a
12 component meeting the standards, the department shall order
13 the owner of the radiation machine to make the necessary
14 adjustment or to purchase the necessary component within 90
15 days after of the date or receipt of the order. However, if
16 the radiation machine cannot be made to meet the standards,
17 the department shall order the owner to cease the use
18 utilization of the radiation machine.
19 Section 31. Subsection (3) of section 489.553, Florida
20 Statutes, is amended to read:
21 489.553 Administration of part; registration
22 qualifications; examination.--
23 (3) The department shall adopt reasonable rules,
24 including, but not limited to, rules that which establish
25 ethical standards of practice, requirements for registering as
26 a contractor, requirements for obtaining an initial or renewal
27 certificate of registration, disciplinary guidelines, and
28 requirements for the certification of partnerships and
29 corporations. The department and may amend or repeal the rules
30 same in accordance with the Administrative Procedure Act.
31
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1 Section 32. Subsection (1) of section 491.006, Florida
2 Statutes, is amended to read:
3 491.006 Licensure or certification by endorsement.--
4 (1) The department shall license or grant a
5 certificate to a person in a profession regulated by this
6 chapter who, upon applying to the department and remitting the
7 appropriate fee, demonstrates to the board that he or she:
8 (a) Has demonstrated, in a manner designated by rule
9 of the board, knowledge of the laws and rules governing the
10 practice of clinical social work, marriage and family therapy,
11 and mental health counseling.
12 (b)1. Holds an active valid license to practice and
13 has actively practiced the profession for which licensure is
14 applied in another state for 3 of the last 5 years immediately
15 preceding licensure.
16 2. Meets the education requirements of this chapter
17 for the profession for which licensure is applied.
18 3. Has passed a substantially equivalent licensing
19 examination in another state or has passed the licensure
20 examination in this state in the profession for which the
21 applicant seeks licensure.
22 4. Holds a license in good standing, is not under
23 investigation for an act that which would constitute a
24 violation of this chapter, and has not been found to have
25 committed any act that which would constitute a violation of
26 this chapter. The fees paid by any applicant for certification
27 as a master social worker under this section are
28 nonrefundable.
29 Section 33. Subsections (1) and (5) of section
30 491.0145, Florida Statutes, are amended to read:
31
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1 491.0145 Certified master social worker.--The
2 department may certify an applicant for a designation as a
3 certified master social worker upon the following conditions:
4 (1) The applicant completes an application to be
5 provided by the department and pays a nonrefundable fee not to
6 exceed $250 to be established by rule of the department. The
7 completed application must be received by the department at
8 least 60 days before the date of the examination in order for
9 the applicant to qualify to take the scheduled exam.
10 (5) The applicant has passed an examination required
11 by the department for this purpose. The nonrefundable fee for
12 such examination may shall not exceed $250 as set by
13 department rule.
14 Section 34. Present subsections (11) through (29) of
15 section 499.003, Florida Statutes, are redesignated as
16 subsections (12) through (30), respectively, and a new
17 subsection (11) is added to that section, to read:
18 499.003 Definitions of terms used in ss.
19 499.001-499.081.--As used in ss. 499.001-499.081, the term:
20 (11) "Distribute or distribution" means to sell; offer
21 to sell; give away; transfer, whether by passage of title,
22 physical movement, or both; deliver; or offer to deliver. The
23 term does not mean to administer or dispense.
24 Section 35. Subsections (25) and (26) are added to
25 section 499.005, Florida Statutes, to read:
26 499.005 Prohibited acts.--It is unlawful to perform or
27 cause the performance of any of the following acts in this
28 state:
29 (25) Charging a dispensing fee for dispensing,
30 administering, or distributing a prescription drug sample.
31
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1 (26) Dispensing, administering, or distributing an
2 investigational drug authorized under s. 499.018, except
3 pursuant to a protocol approved by the department.
4 Section 36. Subsection (8) is added to section
5 499.0054, Florida Statutes, to read:
6 499.0054 Advertising and labeling of drugs, devices,
7 and cosmetics.--It is a violation of the Florida Drug and
8 Cosmetic Act to perform or cause the performance of any of the
9 following acts:
10 (8) The representation or suggestion in labeling or
11 advertising that an article is approved under ss.
12 499.001-499.081, when such is not the case.
13 Section 37. Subsection (2) and paragraph (d) of
14 subsection (4) of section 499.01, Florida Statutes, are
15 amended to read:
16 499.01 Permits; applications; renewal; general
17 requirements.--
18 (2) The department shall establish, by rule, the form
19 and content of the application to obtain or renew a permit.
20 The applicant must submit to the department with the
21 application a statement that swears or affirms that the
22 information is true and correct.
23 (a) Information that an applicant must provide
24 includes, but need not be limited to:
25 1. The name, full business address, and telephone
26 number of the applicant;
27 2. All trade or business names used by the applicant;
28 3. The address, telephone numbers, and the names of
29 contact persons for each facility used by the applicant for
30 the storage, handling, and distribution of prescription drugs;
31
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1 4. The type of ownership or operation, such as a
2 partnership, corporation, or sole proprietorship; and
3 5. The names of the owner and the operator of the
4 establishment, including:
5 a. If an individual, the name of the individual;
6 b. If a partnership, the name of each partner and the
7 name of the partnership;
8 c. If a corporation, the name and title of each
9 corporate officer and director, the corporate names, and the
10 name of the state of incorporation;
11 d. If a sole proprietorship, the full name of the sole
12 proprietor and the name of the business entity; and
13 e. Any other relevant information that the department
14 requires.
15 (b) Upon approval of the application by the department
16 and payment of the required fee, the department shall issue a
17 permit to the applicant, if the applicant meets the
18 requirements of ss. 499.001-499.081 and rules adopted under
19 those sections.
20 (c) Any change in information required under paragraph
21 (a) must be submitted to the department before the change
22 occurs.
23 (d) The department shall consider, at a minimum, the
24 following factors in reviewing the qualifications of persons
25 to be permitted under ss. 499.001-499.081:
26 1. The applicant's having been found guilty,
27 regardless of adjudication, in a court of this state or other
28 jurisdiction, of a violation of a law that directly relates to
29 a drug, device, or cosmetic. A plea of nolo contendere
30 constitutes a finding of guilt for purposes of this
31 subparagraph.
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1 2. The applicant's having been disciplined by a
2 regulatory agency in any state for any offense that would
3 constitute a violation of ss. 499.001-499.081.
4 3. Any felony conviction of the applicant under a
5 federal, state, or local law;
6 4. The applicant's past experience in manufacturing or
7 distributing drugs, devices, or cosmetics;
8 5. The furnishing by the applicant of false or
9 fraudulent material in any application made in connection with
10 manufacturing or distributing drugs, devices, or cosmetics;
11 6. Suspension or revocation by a federal, state, or
12 local government of any permit currently or previously held by
13 the applicant for the manufacture or distribution of any
14 drugs, devices, or cosmetics;
15 7. Compliance with permitting requirements under any
16 previously granted permits;
17 8. Compliance with requirements to maintain or make
18 available to the state permitting authority or to federal,
19 state, or local law enforcement officials those records
20 required under this section; and
21 9. Any other factors or qualifications the department
22 considers relevant to and consistent with the public health
23 and safety.
24 (4) A permit issued by the department is
25 nontransferable. Each permit is valid only for the person or
26 governmental unit to which it is issued and is not subject to
27 sale, assignment, or other transfer, voluntarily or
28 involuntarily; nor is a permit valid for any establishment
29 other than the establishment for which it was originally
30 issued.
31
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1 (d) If an establishment permitted under ss.
2 499.001-499.081 closes, the owner must notify the department
3 in writing before the effective date of closure and must:
4 1. Return the permit to the department;
5 2. If the permittee is authorized to distribute legend
6 drugs, indicate the disposition of such drugs, including the
7 name, address, and inventory, and provide the name and address
8 of a person to contact regarding access to records that are
9 required to be maintained under ss. 499.001-499.081. Transfer
10 of ownership of legend drugs may be made only to persons
11 authorized to possess legend drugs under ss. 499.001-499.081.
12 Section 38. Paragraph (c) is added to subsection (2)
13 of section 499.0121, Florida Statutes, to read:
14 499.0121 Storage and handling of prescription
15 drugs.--The department shall adopt rules to implement this
16 section as necessary to protect the public health, safety, and
17 welfare. Such rules shall include, but not be limited to,
18 requirements for the storage and handling of prescription
19 drugs and for the establishment and maintenance of
20 prescription drug distribution records.
21 (2) SECURITY.--
22 (c) Any vehicle that contains prescription drugs must
23 be secure from unauthorized access to the prescription drugs
24 in the vehicle.
25 Section 39. Paragraph (b) of subsection (2) of section
26 499.0122, Florida Statutes, is amended to read:
27 499.0122 Medical oxygen and veterinary legend drug
28 retail establishments; definitions, permits, general
29 requirements.--
30 (2)
31
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1 (b) The department shall adopt rules relating to
2 information required from each retail establishment pursuant
3 to s. 499.01(2), including requirements for prescriptions or
4 orders.
5 Section 40. Paragraph (d) of subsection (2) of section
6 499.013, Florida Statutes, is amended, and subsection (4) is
7 added to that section, to read:
8 499.013 Manufacturers of drugs, devices, and
9 cosmetics; definitions, permits, and general requirements.--
10 (2) Any person that engages in the manufacture of
11 drugs, devices, or cosmetics in this state must first obtain
12 one of the following permits and may engage only in the
13 activity allowed under that permit:
14 (d) A device manufacturer's permit is required for any
15 person that engages in the manufacture or assembly of medical
16 devices for human use in this state, except that a permit is
17 not required if the person is engaged only in manufacturing or
18 assembling a medical device pursuant to a practitioner's order
19 for a specific patient.
20 1. A manufacturer of medical devices in this state
21 must comply with all appropriate state and federal good
22 manufacturing practices.
23 2. The department shall adopt rules related to
24 storage, handling, and recordkeeping requirements for
25 manufacturers of medical devices for human use.
26 (4) Each manufacturer of medical devices,
27 over-the-counter drugs, or cosmetics must maintain records
28 that include the name and principal address of the seller or
29 transferor of the product, the address of the location from
30 which the product was shipped, the date of the transaction,
31
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1 the name and quantity of the product involved, and the name
2 and principal address of the person who purchased the product.
3 Section 41. Subsections (1) and (3) of section
4 499.015, Florida Statutes, are amended to read:
5 499.015 Registration of drugs, devices, and cosmetics;
6 issuance of certificates of free sale.--
7 (1)(a) Except for those persons exempted from the
8 definition in s. 499.003(22) s. 499.003(21), any person who
9 manufactures, packages, repackages, labels, or relabels a
10 drug, device, or cosmetic in this state must register such
11 drug, device, or cosmetic biennially with the department; pay
12 a fee in accordance with the fee schedule provided by s.
13 499.041; and comply with this section. The registrant must
14 list each separate and distinct drug, device, or cosmetic at
15 the time of registration.
16 (b) The department may not register any product that
17 does not comply with the Federal Food, Drug, and Cosmetic Act,
18 as amended, or Title 21 C.F.R., or that is not an approved
19 investigational drug as provided for in s. 499.018.
20 Registration of a product by the department does not mean that
21 the product does in fact comply with all provisions of the
22 Federal Food, Drug, and Cosmetic Act, as amended.
23 (3) Except for those persons exempted from the
24 definition in s. 499.003(22) s. 499.003(21), a person may not
25 sell any product that he or she has failed to register in
26 conformity with this section. Such failure to register
27 subjects such drug, device, or cosmetic product to seizure and
28 condemnation as provided in ss. 499.062-499.064, and subjects
29 such person to the penalties and remedies provided in ss.
30 499.001-499.081.
31
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1 Section 42. Subsection (4) of section 499.024, Florida
2 Statutes, is amended to read:
3 499.024 Drug product classification.--The secretary
4 shall adopt rules to classify drug products intended for use
5 by humans which the United States Food and Drug Administration
6 has not classified in the federal act or the Code of Federal
7 Regulations.
8 (4) Any product that falls under the drug definition,
9 s. 499.003(12) s. 499.003(11), may be classified under the
10 authority of this section. This section does not subject
11 portable emergency oxygen inhalators to classification;
12 however, this section does not exempt any person from ss.
13 499.01 and 499.015.
14 Section 43. Subsection (1) of section 499.03, Florida
15 Statutes, is amended to read:
16 499.03 Possession of new drugs or legend drugs without
17 prescriptions unlawful; exemptions and exceptions.--
18 (1) A person may not possess, or possess with intent
19 to sell, dispense, or deliver, any habit-forming, toxic,
20 harmful, or new drug subject to s. 499.003(23) s. 499.003(22),
21 or legend drug as defined in s. 499.003, unless the possession
22 of the drug has been obtained by a valid prescription of a
23 practitioner licensed by law to prescribe the drug. However,
24 this section does not apply to the delivery of such drugs to
25 persons included in any of the classes named in this
26 subsection, or to the agents or employees of such persons, for
27 use in the usual course of their businesses or practices or in
28 the performance of their official duties, as the case may be;
29 nor does this section apply to the possession of such drugs by
30 those persons or their agents or employees for such use:
31
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1 (a) A licensed pharmacist or any person under the
2 licensed pharmacist's supervision while acting within the
3 scope of the licensed pharmacist's practice;
4 (b) A licensed practitioner authorized by law to
5 prescribe legend drugs or any person under the licensed
6 practitioner's supervision while acting within the scope of
7 the licensed practitioner's practice;
8 (c) A qualified person who uses legend drugs for
9 lawful research, teaching, or testing, and not for resale;
10 (d) A licensed hospital or other institution that
11 procures such drugs for lawful administration or dispensing by
12 practitioners;
13 (e) An officer or employee of a federal, state, or
14 local government; or
15 (f) A person that holds a valid permit issued by the
16 department pursuant to ss. 499.001-499.081 which authorizes
17 that person to possess prescription drugs.
18 Section 44. Subsection (1) of section 499.05, Florida
19 Statutes, is amended to read:
20 499.05 Rules.--
21 (1) The department shall adopt rules to implement and
22 enforce ss. 499.001-499.081 with respect to:.
23 (a) The definition of terms used in ss.
24 499.001-499.081, and used in the rules adopted under ss.
25 499.001-499.081, when the use of the term is not its usual and
26 ordinary meaning.
27 (b) Labeling requirements for drugs, devices, and
28 cosmetics.
29 (c) Application requirements, protocols, reporting
30 requirements, and requirements for submitting other
31 information to the department and the Florida Drug Technical
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1 Review Panel, as required under the investigational drug
2 program.
3 (d) The establishment of fees authorized in ss.
4 499.001-499.081.
5 (e) The identification of permits that require an
6 initial application and onsite inspection or other
7 prerequisites for permitting which demonstrate that the
8 establishment and person are in compliance with the
9 requirements of ss. 499.001-499.081.
10 (f) The application processes and forms for product
11 registration.
12 (g) Procedures for requesting and issuing certificates
13 of free sale.
14 (h) Inspections and investigations conducted under s.
15 499.051, and the identification of information claimed to be a
16 trade secret and exempt from the public records law as
17 provided in s. 499.051(5).
18 (i) The establishment of a range of penalties, as
19 provided in s. 499.006; requirements for notifying persons of
20 the potential impact of a violation of ss. 499.001-499.081;
21 and a process for the uncontested settlement of alleged
22 violations.
23 (j) Additional conditions that qualify as an emergency
24 medical reason under s. 499.012(1)(a)2.b.
25 Section 45. Section 499.701, Florida Statutes, is
26 amended to read:
27 499.701 Adoption of rules by the department.--
28 (1) The department shall adopt and enforce rules
29 necessary to the administration of its authority under this
30 part. The Said rules must shall be such as are reasonably
31 necessary for the protection of the health, welfare, and
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1 safety of the public and persons manufacturing, distributing,
2 dealing, and possessing ether, and must provide for
3 application forms and procedures, recordkeeping requirements,
4 and security. The rules must and shall be in substantial
5 conformity with generally accepted standards of safety
6 concerning such subject matter.
7 (2) The department may adopt rules regarding
8 recordkeeping and security for methyl ethyl ketone (MEK) or
9 butyl acetate as needed. These products and records are open
10 to inspection in the same manner as are ether products and
11 records.
12 Section 46. Paragraph (d) of subsection (2) of section
13 501.122, Florida Statutes, is amended to read:
14 501.122 Control of nonionizing radiations; laser;
15 penalties.--
16 (2) AUTHORITY TO ISSUE REGULATIONS.--Except for
17 electrical transmission and distribution lines and substation
18 facilities subject to regulation by the Department of
19 Environmental Protection pursuant to chapter 403, the
20 Department of Health shall adopt rules as necessary to protect
21 the health and safety of persons exposed to laser devices and
22 other nonionizing radiation, including the user or any others
23 who might come in contact with such radiation. The Department
24 of Health may:
25 (d) Establish and prescribe performance standards for
26 lasers and other radiation control, including requirements for
27 radiation surveys and measurements and the methods and
28 instruments used to perform surveys; the qualifications,
29 duties, and training of users; the posting of warning signs
30 and labels for facilities and devices; recordkeeping; and
31 reports to the department, if it determines that such
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1 standards are necessary for the protection of the public
2 health.
3 Section 47. Section 513.05, Florida Statutes, is
4 amended to read:
5 513.05 Rules.--The department may adopt rules
6 pertaining to the location, construction, modification,
7 equipment, and operation of mobile home parks, lodging parks,
8 recreational vehicle parks, and recreational camps, except as
9 provided in s. 633.022, as necessary to administer implement
10 this chapter. Such rules may include definitions of terms;
11 requirements for plan reviews of proposed and existing parks
12 and camps; plan reviews of parks that consolidate space or
13 change space size; water supply; sewage collection and
14 disposal; plumbing and backflow prevention; garbage and refuse
15 storage, collection, and disposal; insect and rodent control;
16 space requirements; heating facilities; food service;
17 lighting; sanitary facilities; bedding; an occupancy
18 equivalency to spaces for permits for recreational camps;
19 sanitary facilities in recreational vehicle parks; and the
20 owners' responsibilities at recreational vehicle parks and
21 recreational camps.
22 Section 48. Section 514.021, Florida Statutes, is
23 amended to read:
24 514.021 Department authorization.--The department may
25 is authorized to adopt and enforce rules, which may include
26 definitions of terms, to protect the health, safety, or
27 welfare of persons using public swimming pools and bathing
28 places. The department shall review and revise such rules as
29 necessary, but not less than biannually. Sanitation and safety
30 standards shall include, but not be limited to, matters
31 relating to structure; appurtenances; operation; source of
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1 water supply; bacteriological, chemical, and physical quality
2 of water in the pool or bathing area; method of water
3 purification, treatment, and disinfection; lifesaving
4 apparatus; measures to ensure safety of bathers; and measures
5 to ensure the personal cleanliness of bathers.
6 Section 49. Section 766.1115, Florida Statutes, is
7 amended to read:
8 766.1115 Health care providers; creation of agency
9 relationship with governmental contractors.--
10 (1) SHORT TITLE.--This section may be cited as the
11 "Access to Health Care Act."
12 (2) FINDINGS AND INTENT.--The Legislature finds that a
13 significant proportion of the residents of this state who are
14 uninsured or Medicaid recipients are unable to access needed
15 health care because health care providers fear the increased
16 risk of medical malpractice liability. It is the intent of
17 the Legislature that access to medical care for indigent
18 residents be improved by providing governmental protection to
19 health care providers who offer free quality medical services
20 to underserved populations of the state. Therefore, it is the
21 intent of the Legislature to ensure that health care
22 professionals who contract to provide such services as agents
23 of the state are provided sovereign immunity.
24 (3) DEFINITIONS.--As used in this section, the term:
25 (a) "Contract" means an agreement executed in
26 compliance with this section between a health care provider
27 and a governmental contractor. This contract shall allow the
28 health care provider to deliver health care services to
29 low-income recipients as an agent of the governmental
30 contractor. The contract must be for volunteer, uncompensated
31 services.
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1 (b) "Department" means the Department of Health.
2 (c) "Governmental contractor" means the department,
3 county health departments, a special taxing district with
4 health care responsibilities, or a hospital owned and operated
5 by a governmental entity.
6 (d) "Health care provider" or "provider" means:
7 1. A birth center licensed under chapter 383.
8 2. An ambulatory surgical center licensed under
9 chapter 395.
10 3. A hospital licensed under chapter 395.
11 4. A physician or physician assistant licensed under
12 chapter 458.
13 5. An osteopathic physician or osteopathic physician
14 assistant licensed under chapter 459.
15 6. A chiropractic physician licensed under chapter
16 460.
17 7. A podiatric physician licensed under chapter 461.
18 8. A registered nurse, nurse midwife, licensed
19 practical nurse, or advanced registered nurse practitioner
20 licensed or registered under chapter 464 or any facility which
21 employs nurses licensed or registered under chapter 464 to
22 supply all or part of the care delivered under this section.
23 9. A midwife licensed under chapter 467.
24 10. A health maintenance organization certificated
25 under part I of chapter 641.
26 11. A health care professional association and its
27 employees or a corporate medical group and its employees.
28 12. Any other medical facility the primary purpose of
29 which is to deliver human medical diagnostic services or which
30 delivers nonsurgical human medical treatment, and which
31 includes an office maintained by a provider.
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1 13. A dentist or dental hygienist licensed under
2 chapter 466.
3 14. Any other health care professional, practitioner,
4 provider, or facility under contract with a governmental
5 contractor, including a student enrolled in an accredited
6 program that prepares the student for licensure as any one of
7 the professionals listed in subparagraphs 4. through 9.
8
9 The term includes any nonprofit corporation qualified as
10 exempt from federal income taxation under s. 501(c) of the
11 Internal Revenue Code which delivers health care services
12 provided by licensed professionals listed in this paragraph,
13 any federally funded community health center, and any
14 volunteer corporation or volunteer health care provider that
15 delivers health care services.
16 (e) "Low-income" means:
17 1. A person who is Medicaid-eligible under Florida
18 law;
19 2. A person who is without health insurance and whose
20 family income does not exceed 150 percent of the federal
21 poverty level as defined annually by the federal Office of
22 Management and Budget; or
23 3. Any client of the department who voluntarily
24 chooses to participate in a program offered or approved by the
25 department and meets the program eligibility guidelines of the
26 department.
27 (4) CONTRACT REQUIREMENTS.--A health care provider
28 that executes a contract with a governmental contractor to
29 deliver health care services on or after April 17, 1992, as an
30 agent of the governmental contractor is an agent for purposes
31 of s. 768.28(9), while acting within the scope of duties
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1 pursuant to the contract, if the contract complies with the
2 requirements of this section and regardless of whether the
3 individual treated is later found to be ineligible. A health
4 care provider under contract with the state may not be named
5 as a defendant in any action arising out of the medical care
6 or treatment provided on or after April 17, 1992, pursuant to
7 contracts entered into under this section. The contract must
8 provide that:
9 (a) The right of dismissal or termination of any
10 health care provider delivering services pursuant to the
11 contract is retained by the governmental contractor.
12 (b) The governmental contractor has access to the
13 patient records of any health care provider delivering
14 services pursuant to the contract.
15 (c) Adverse incidents and information on treatment
16 outcomes must be reported by any health care provider to the
17 governmental contractor if such incidents and information
18 pertain to a patient treated pursuant to the contract. The
19 health care provider shall annually submit an adverse incident
20 report that includes all information required by s.
21 395.0197(6)(a), unless the adverse incident involves a result
22 described by s. 395.0197(8), in which case it shall be
23 reported within 15 days after the occurrence of such incident.
24 If an incident involves a professional licensed by the
25 Department of Health or a facility licensed by the Agency for
26 Health Care Administration, the governmental contractor shall
27 submit such incident reports to the appropriate department or
28 agency, which shall review each incident and determine whether
29 it involves conduct by the licensee that is subject to
30 disciplinary action. All patient medical records and any
31 identifying information contained in adverse incident reports
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1 and treatment outcomes which are obtained by governmental
2 entities pursuant to this paragraph are confidential and
3 exempt from the provisions of s. 119.07(1) and s. 24(a), Art.
4 I of the State Constitution.
5 (d) Patient selection and initial referral must be
6 made solely by the governmental contractor, and the provider
7 must accept all referred patients. However, the number of
8 patients that must be accepted may be limited by the contract,
9 and patients may not be transferred to the provider based on a
10 violation of the antidumping provisions of the Omnibus Budget
11 Reconciliation Act of 1989, the Omnibus Budget Reconciliation
12 Act of 1990, or chapter 395.
13 (e) If emergency care is required, the patient need
14 not be referred before receiving treatment, but must be
15 referred within 48 hours after treatment is commenced or
16 within 48 hours after the patient has the mental capacity to
17 consent to treatment, whichever occurs later.
18 (f) Patient care, including any followup or hospital
19 care, is subject to approval by the governmental contractor.
20 (g) The provider is subject to supervision and regular
21 inspection by the governmental contractor.
22
23 A governmental contractor that is also a health care provider
24 is not required to enter into a contract under this section
25 with respect to the health care services delivered by its
26 employees.
27 (5) NOTICE OF AGENCY RELATIONSHIP.--The governmental
28 contractor must provide written notice to each patient, or the
29 patient's legal representative, receipt of which must be
30 acknowledged in writing, that the provider is an agent of the
31 governmental contractor and that the exclusive remedy for
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1 injury or damage suffered as the result of any act or omission
2 of the provider or of any employee or agent thereof acting
3 within the scope of duties pursuant to the contract is by
4 commencement of an action pursuant to the provisions of s.
5 768.28. With respect to any federally funded community health
6 center, the notice requirements may be met by posting in a
7 place conspicuous to all persons a notice that the federally
8 funded community health center is an agent of the governmental
9 contractor and that the exclusive remedy for injury or damage
10 suffered as the result of any act or omission of the provider
11 or of any employee or agent thereof acting within the scope of
12 duties pursuant to the contract is by commencement of an
13 action pursuant to the provisions of s. 768.28.
14 (6) QUALITY ASSURANCE PROGRAM REQUIRED.--The
15 governmental contractor shall establish a quality assurance
16 program to monitor services delivered under any contract
17 between an agency and a health care provider pursuant to this
18 section.
19 (7) RISK MANAGEMENT REPORT.--The Division of Risk
20 Management of the Department of Insurance shall annually
21 compile a report of all claims statistics for all entities
22 participating in the risk management program administered by
23 the division, which shall include the number and total of all
24 claims pending and paid, and defense and handling costs
25 associated with all claims brought against contract providers
26 under this section. This report shall be forwarded to the
27 department and included in the annual report submitted to the
28 Legislature pursuant to this section.
29 (8) REPORT TO THE LEGISLATURE.--Annually, the
30 department shall report to the President of the Senate, the
31 Speaker of the House of Representatives, and the minority
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1 leaders and relevant substantive committee chairpersons of
2 both houses, summarizing the efficacy of access and treatment
3 outcomes with respect to providing health care services for
4 low-income persons pursuant to this section.
5 (9) MALPRACTICE LITIGATION COSTS.--Governmental
6 contractors other than the department are responsible for
7 their own costs and attorney's fees for malpractice litigation
8 arising out of health care services delivered pursuant to this
9 section.
10 (10) RULES.--The department shall adopt rules designed
11 to administer implement this section in a manner consistent
12 with its purpose to provide and facilitate access to
13 appropriate, safe, and cost-effective health care services and
14 to maintain health care quality. The rules may include
15 services to be provided and authorized procedures.
16 (11) APPLICABILITY.--This section applies to incidents
17 occurring on or after April 17, 1992. This section does not
18 apply to any health care contract entered into by the
19 Department of Corrections which is subject to s.
20 768.28(10)(a). Nothing in this section in any way reduces or
21 limits the rights of the state or any of its agencies or
22 subdivisions to any benefit currently provided under s.
23 768.28.
24 Section 50. This act shall take effect upon becoming a
25 law.
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