Senate Bill 2628c1

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    Florida Senate - 2000                           CS for SB 2628

    By the Committee on Health, Aging and Long-Term Care; and
    Senator Myers




    317-2044-00

  1                      A bill to be entitled

  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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    Florida Senate - 2000                           CS for SB 2628
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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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    Florida Senate - 2000                           CS for SB 2628
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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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    Florida Senate - 2000                           CS for SB 2628
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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 standards for system

  3  inspection.

  4         (b)  Perform application reviews and site evaluations,

  5  issue permits, and conduct inspections and complaint

  6  investigations associated with the construction, installation,

  7  maintenance, modification, abandonment, operation, use, or

  8  repair of an onsite sewage treatment and disposal system for a

  9  residence or establishment with an estimated domestic sewage

10  flow of 10,000 gallons or less per day, or an estimated

11  commercial sewage flow of 5,000 gallons or less per day, which

12  is not currently regulated under chapter 403.

13         (c)  Develop a comprehensive program to ensure that

14  onsite sewage treatment and disposal systems regulated by the

15  department are sized, designed, constructed, installed,

16  repaired, modified, abandoned, used, operated, and maintained

17  in compliance with this section and rules adopted under this

18  section to prevent groundwater contamination and surface water

19  contamination and to preserve the public health.  The

20  department is the final administrative interpretive authority

21  regarding rule interpretation.  In the event of a conflict

22  regarding rule interpretation, the Division Director for

23  Environmental Health of the department, or his or her

24  designee, shall timely assign a staff person to resolve the

25  dispute.

26         (d)  Grant variances in hardship cases under the

27  conditions prescribed in this section and rules adopted under

28  this section.

29         (e)  Permit the use of a limited number of innovative

30  systems for a specific period of time, when there is

31  compelling evidence that the system will function properly and

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  1  reliably to meet the requirements of this section and rules

  2  adopted under this section.

  3         (f)  Issue annual operating permits under this section.

  4         (g)  Establish and collect fees as established under s.

  5  381.0066 for services provided with respect to onsite sewage

  6  treatment and disposal systems.

  7         (h)  Conduct enforcement activities, including imposing

  8  fines, issuing citations, suspensions, revocations,

  9  injunctions, and emergency orders for violations of this

10  section, part I of chapter 386, or part III of chapter 489 or

11  for a violation of any rule adopted under this section, part I

12  of chapter 386, or part III of chapter 489.

13         (i)  Provide or conduct education and training of

14  department personnel, service providers, and the public

15  regarding onsite sewage treatment and disposal systems.

16         (j)  Supervise research on, demonstration of, and

17  training on the performance, environmental impact, and public

18  health impact of onsite sewage treatment and disposal systems

19  within this state.  Research fees collected under s.

20  381.0066(2)(k) must be used to develop and fund hands-on

21  training centers designed to provide practical information

22  about onsite sewage treatment and disposal systems to septic

23  tank contractors, master septic tank contractors, contractors,

24  inspectors, engineers, and the public and must also be used to

25  fund research projects which focus on improvements of onsite

26  sewage treatment and disposal systems, including use of

27  performance-based standards and reduction of environmental

28  impact.  Research projects shall be initially approved by the

29  technical advisory panel and shall be applicable to and

30  reflect the soil conditions specific to Florida.  Such

31  projects shall be awarded through competitive negotiation,

                                  17

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  1  using the procedures provided in s. 287.055, to public or

  2  private entities that have experience in onsite sewage

  3  treatment and disposal systems in Florida and that are

  4  principally located in Florida.  Research projects shall not

  5  be awarded to firms or entities that employ or are associated

  6  with persons who serve on either the technical advisory panel

  7  or the research review and advisory committee.

  8         (k)  Approve the installation of individual graywater

  9  disposal systems in which blackwater is treated by a central

10  sewerage system.

11         (l)  Regulate and permit the sanitation, handling,

12  treatment, storage, reuse, and disposal of byproducts from any

13  system regulated under this chapter and septage-stabilization

14  and disposal facilities not regulated by the Department of

15  Environmental Protection.

16         (m)  Permit and inspect portable or temporary toilet

17  services and holding tanks. The department shall review

18  applications, perform site evaluations, and issue permits for

19  the temporary use of holding tanks, privies, portable toilet

20  services, or any other toilet facility that is intended for

21  use on a permanent or nonpermanent basis, including facilities

22  placed on construction sites when workers are present. The

23  department may specify standards for the construction,

24  maintenance, use, and operation of any such facility for

25  temporary use.

26         (4)  PERMITS; INSTALLATION; AND CONDITIONS.--A person

27  may not construct, repair, modify, abandon, or operate an

28  onsite sewage treatment and disposal system without first

29  obtaining a permit approved by the department. The department

30  may issue permits to carry out this section, but shall not

31  make the issuance of such permits contingent upon prior

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  1  approval by the Department of Environmental Protection. A

  2  construction permit is valid for 18 months from the issuance

  3  date and may be extended by the department for one 90-day

  4  period under rules adopted by the department.  A repair permit

  5  is valid for 90 days from the date of issuance. An operating

  6  permit must be obtained prior to the use of any aerobic

  7  treatment unit or if the establishment generates commercial

  8  waste. Buildings or establishments that use an aerobic

  9  treatment unit or generate commercial waste shall be inspected

10  by the department at least annually to assure compliance with

11  the terms of the operating permit. The operating permit is

12  valid for 1 year from the date of issuance and must be renewed

13  annually.  If all information pertaining to the siting,

14  location, and installation conditions or repair of an onsite

15  sewage treatment and disposal system remains the same, a

16  construction or repair permit for the onsite sewage treatment

17  and disposal system may be transferred to another person, if

18  the transferee files, within 60 days after the transfer of

19  ownership, an amended application providing all corrected

20  information and proof of ownership of the property.  There is

21  no fee associated with the processing of this supplemental

22  information.  A person may not contract to construct, modify,

23  alter, repair, service, abandon, or maintain any portion of an

24  onsite sewage treatment and disposal system without being

25  registered under part III of chapter 489.  A property owner

26  who personally performs construction, maintenance, or repairs

27  to a system serving his or her own owner-occupied

28  single-family residence is exempt from registration

29  requirements for performing such construction, maintenance, or

30  repairs on that residence, but is subject to all permitting

31  requirements. A municipality or political subdivision of the

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  1  state may not issue a building or plumbing permit for any

  2  building that requires the use of an onsite sewage treatment

  3  and disposal system unless the owner or builder has received a

  4  construction permit for such system from the department. A

  5  building or structure may not be occupied and a municipality,

  6  political subdivision, or any state or federal agency may not

  7  authorize occupancy until the department approves the final

  8  installation of the onsite sewage treatment and disposal

  9  system. A municipality or political subdivision of the state

10  may not approve any change in occupancy or tenancy of a

11  building that uses an onsite sewage treatment and disposal

12  system until the department has reviewed the use of the system

13  with the proposed change, approved the change, and amended the

14  operating permit.

15         (a)  Subdivisions and lots in which each lot has a

16  minimum area of at least one-half acre and either a minimum

17  dimension of 100 feet or a mean of at least 100 feet of the

18  side bordering the street and the distance formed by a line

19  parallel to the side bordering the street drawn between the

20  two most distant points of the remainder of the lot may be

21  developed with a water system regulated under s. 381.0062 and

22  onsite sewage treatment and disposal systems, provided the

23  projected daily domestic sewage flow does not exceed an

24  average of 1,500 gallons per acre per day, and provided

25  satisfactory drinking water can be obtained and all distance

26  and setback, soil condition, water table elevation, and other

27  related requirements of this section and rules adopted under

28  this section can be met.

29         (b)  Subdivisions and lots using a public water system

30  as defined in s. 403.852 may use onsite sewage treatment and

31  disposal systems, provided there are no more than four lots

                                  20

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  1  per acre, provided the projected daily domestic sewage flow

  2  does not exceed an average of 2,500 gallons per acre per day,

  3  and provided that all distance and setback, soil condition,

  4  water table elevation, and other related requirements that are

  5  generally applicable to the use of onsite sewage treatment and

  6  disposal systems are met.

  7         (c)  Notwithstanding the provisions of paragraphs (a)

  8  and (b), for subdivisions platted of record on or before

  9  October 1, 1991, when a developer or other appropriate entity

10  has previously made or makes provisions, including financial

11  assurances or other commitments, acceptable to the Department

12  of Health, that a central water system will be installed by a

13  regulated public utility based on a density formula, private

14  potable wells may be used with onsite sewage treatment and

15  disposal systems until the agreed-upon densities are reached.

16  The department may consider assurances filed with the

17  Department of Business and Professional Regulation under

18  chapter 498 in determining the adequacy of the financial

19  assurance required by this paragraph.  In a subdivision

20  regulated by this paragraph, the average daily domestic sewage

21  flow may not exceed 2,500 gallons per acre per day.  This

22  section does not affect the validity of existing prior

23  agreements. After October 1, 1991, the exception provided

24  under this paragraph is not available to a developer or other

25  appropriate entity.

26         (d)  Paragraphs (a) and (b) do not apply to any

27  proposed residential subdivision with more than 50 lots or to

28  any proposed commercial subdivision with more than 5 lots

29  where a publicly owned or investor-owned sewerage system is

30  available.  It is the intent of this paragraph not to allow

31  development of additional proposed subdivisions in order to

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  1  evade the requirements of this paragraph.  The department

  2  shall report to the Legislature by February 1 of each

  3  odd-numbered year concerning the success in meeting this

  4  intent.

  5         (e)  Onsite sewage treatment and disposal systems must

  6  not be placed closer than:

  7         1.  Seventy-five feet from a private potable well.

  8         2.  Two hundred feet from a public potable well serving

  9  a residential or nonresidential establishment having a total

10  sewage flow of greater than 2,000 gallons per day.

11         3.  One hundred feet from a public potable well serving

12  a residential or nonresidential establishment having a total

13  sewage flow of less than or equal to 2,000 gallons per day.

14         4.  Fifty feet from any nonpotable well.

15         5.  Ten feet from any storm sewer pipe, to the maximum

16  extent possible, but in no instance shall the setback be less

17  than 5 feet.

18         6.  Seventy-five feet from the mean high-water line of

19  a tidally influenced surface water body;

20         7.  Seventy-five feet from the normal annual flood line

21  of a permanent nontidal surface water body;

22         8.  Fifteen feet from the design high-water line of

23  retention areas, detention areas, or swales designed to

24  contain standing or flowing water for less than 72 hours after

25  a rainfall or the design high-water level of normally dry

26  drainage ditches or normally dry individual lot stormwater

27  retention areas.

28         (f)  Except as provided under paragraphs (e) and (t),

29  no limitations shall be imposed by rule, relating to the

30  distance between an onsite disposal system and any area that

31  either permanently or temporarily has visible surface water.

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  1         (g)  All provisions of this section and rules adopted

  2  under this section relating to soil condition, water table

  3  elevation, distance, and other setback requirements must be

  4  equally applied to all lots, with the following exceptions:

  5         1.  Any residential lot that was platted and recorded

  6  on or after January 1, 1972, or that is part of a residential

  7  subdivision that was approved by the appropriate permitting

  8  agency on or after January 1, 1972, and that was eligible for

  9  an onsite sewage treatment and disposal system construction

10  permit on the date of such platting and recording or approval

11  shall be eligible for an onsite sewage treatment and disposal

12  system construction permit, regardless of when the application

13  for a permit is made. If rules in effect at the time the

14  permit application is filed cannot be met, residential lots

15  platted and recorded or approved on or after January 1, 1972,

16  shall, to the maximum extent possible, comply with the rules

17  in effect at the time the permit application is filed.  At a

18  minimum, however, those residential lots platted and recorded

19  or approved on or after January 1, 1972, but before January 1,

20  1983, shall comply with those rules in effect on January 1,

21  1983, and those residential lots platted and recorded or

22  approved on or after January 1, 1983, shall comply with those

23  rules in effect at the time of such platting and recording or

24  approval.  In determining the maximum extent of compliance

25  with current rules that is possible, the department shall

26  allow structures and appurtenances thereto which were

27  authorized at the time such lots were platted and recorded or

28  approved.

29         2.  Lots platted before 1972 are subject to a 50-foot

30  minimum surface water setback and are not subject to lot size

31  requirements.  The projected daily flow for domestic onsite

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  1  sewage treatment and disposal systems for lots platted before

  2  1972 may not exceed:

  3         a.  Two thousand five hundred gallons per acre per day

  4  for lots served by public water systems as defined in s.

  5  403.852.

  6         b.  One thousand five hundred gallons per acre per day

  7  for lots served by water systems regulated under s. 381.0062.

  8         (h)1.  The department may grant variances in hardship

  9  cases which may be less restrictive than the provisions

10  specified in this section.  If a variance is granted and the

11  onsite sewage treatment and disposal system construction

12  permit has been issued, the variance may be transferred with

13  the system construction permit, if the transferee files,

14  within 60 days after the transfer of ownership, an amended

15  construction permit application providing all corrected

16  information and proof of ownership of the property and if the

17  same variance would have been required for the new owner of

18  the property as was originally granted to the original

19  applicant for the variance.  There is no fee associated with

20  the processing of this supplemental information.  A variance

21  may not be granted under this section until the department is

22  satisfied that:

23         a.  The hardship was not caused intentionally by the

24  action of the applicant;

25         b.  No reasonable alternative, taking into

26  consideration factors such as cost, exists for the treatment

27  of the sewage; and

28         c.  The discharge from the onsite sewage treatment and

29  disposal system will not adversely affect the health of the

30  applicant or the public or significantly degrade the

31  groundwater or surface waters.

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  1

  2  Where soil conditions, water table elevation, and setback

  3  provisions are determined by the department to be

  4  satisfactory, special consideration must be given to those

  5  lots platted before 1972.

  6         2.  The department shall appoint and staff a variance

  7  review and advisory committee, which shall meet monthly to

  8  recommend agency action on variance requests. The committee

  9  shall make its recommendations on variance requests at the

10  meeting in which the application is scheduled for

11  consideration, except for an extraordinary change in

12  circumstances, the receipt of new information that raises new

13  issues, or when the applicant requests an extension. The

14  committee shall consider the criteria in subparagraph 1. in

15  its recommended agency action on variance requests and shall

16  also strive to allow property owners the full use of their

17  land where possible. The committee consists of the following:

18         a.  The Division Director for Environmental Health of

19  the department or his or her designee.

20         b.  A representative from the county health

21  departments.

22         c.  A representative from the home building industry

23  recommended by the Florida Home Builders Association.

24         d.  A representative from the septic tank industry

25  recommended by the Florida Septic Tank Association.

26         e.  A representative from the Department of

27  Environmental Protection.

28         f.  A representative from the real estate industry who

29  is also a developer in this state who develops lots using

30  onsite sewage treatment and disposal systems, recommended by

31  the Florida Association of Realtors.

                                  25

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  1         g.  A representative from the engineering profession

  2  recommended by the Florida Engineering Society.

  3

  4  Members shall be appointed for a term of 3 years, with such

  5  appointments being staggered so that the terms of no more than

  6  two members expire in any one year.  Members shall serve

  7  without remuneration, but if requested, shall be reimbursed

  8  for per diem and travel expenses as provided in s. 112.061.

  9         (i)  A construction permit may not be issued for an

10  onsite sewage treatment and disposal system in any area zoned

11  or used for industrial or manufacturing purposes, or its

12  equivalent, where a publicly owned or investor-owned sewage

13  treatment system is available, or where a likelihood exists

14  that the system will receive toxic, hazardous, or industrial

15  waste.  An existing onsite sewage treatment and disposal

16  system may be repaired if a publicly owned or investor-owned

17  sewerage system is not available within 500 feet of the

18  building sewer stub-out and if system construction and

19  operation standards can be met.  This paragraph does not

20  require publicly owned or investor-owned sewerage treatment

21  systems to accept anything other than domestic wastewater.

22         1.  A building located in an area zoned or used for

23  industrial or manufacturing purposes, or its equivalent, when

24  such building is served by an onsite sewage treatment and

25  disposal system, must not be occupied until the owner or

26  tenant has obtained written approval from the department.  The

27  department shall not grant approval when the proposed use of

28  the system is to dispose of toxic, hazardous, or industrial

29  wastewater or toxic or hazardous chemicals.

30         2.  Each person who owns or operates a business or

31  facility in an area zoned or used for industrial or

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  1  manufacturing purposes, or its equivalent, or who owns or

  2  operates a business that has the potential to generate toxic,

  3  hazardous, or industrial wastewater or toxic or hazardous

  4  chemicals, and uses an onsite sewage treatment and disposal

  5  system that is installed on or after July 5, 1989, must obtain

  6  an annual system operating permit from the department.  A

  7  person who owns or operates a business that uses an onsite

  8  sewage treatment and disposal system that was installed and

  9  approved before July 5, 1989, need not obtain a system

10  operating permit. However, upon change of ownership or

11  tenancy, the new owner or operator must notify the department

12  of the change, and the new owner or operator must obtain an

13  annual system operating permit, regardless of the date that

14  the system was installed or approved.

15         3.  The department shall periodically review and

16  evaluate the continued use of onsite sewage treatment and

17  disposal systems in areas zoned or used for industrial or

18  manufacturing purposes, or its equivalent, and may require the

19  collection and analyses of samples from within and around such

20  systems.  If the department finds that toxic or hazardous

21  chemicals or toxic, hazardous, or industrial wastewater have

22  been or are being disposed of through an onsite sewage

23  treatment and disposal system, the department shall initiate

24  enforcement actions against the owner or tenant to ensure

25  adequate cleanup, treatment, and disposal.

26         (j)  An onsite sewage treatment and disposal system for

27  a single-family residence that is designed by a professional

28  engineer registered in the state and certified by such

29  engineer as complying with performance criteria adopted by the

30  department must be approved by the department subject to the

31  following:

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  1         1.  The performance criteria applicable to

  2  engineer-designed systems must be limited to those necessary

  3  to ensure that such systems do not adversely affect the public

  4  health or significantly degrade the groundwater or surface

  5  water.  Such performance criteria shall include consideration

  6  of the quality of system effluent, the proposed total sewage

  7  flow per acre, wastewater treatment capabilities of the

  8  natural or replaced soil, water quality classification of the

  9  potential surface-water-receiving body, and the structural and

10  maintenance viability of the system for the treatment of

11  domestic wastewater.  However, performance criteria shall

12  address only the performance of a system and not a system's

13  design.

14         2.  The technical review and advisory panel shall

15  assist the department in the development of performance

16  criteria applicable to engineer-designed systems.  Workshops

17  on the development of the rules delineating such criteria

18  shall commence not later than September 1, 1996, and the

19  department shall advertise such rules for public hearing no

20  later than October 1, 1997.

21         3.  A person electing to utilize an engineer-designed

22  system shall, upon completion of the system design, submit

23  such design, certified by a registered professional engineer,

24  to the county health department.  The county health department

25  may utilize an outside consultant to review the

26  engineer-designed system, with the actual cost of such review

27  to be borne by the applicant. Within 5 working days after

28  receiving an engineer-designed system permit application, the

29  county health department shall request additional information

30  if the application is not complete.  Within 15 working days

31  after receiving a complete application for an

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  1  engineer-designed system, the county health department either

  2  shall issue the permit or, if it determines that the system

  3  does not comply with the performance criteria, shall notify

  4  the applicant of that determination and refer the application

  5  to the department for a determination as to whether the system

  6  should be approved, disapproved, or approved with

  7  modification. The department engineer's determination shall

  8  prevail over the action of the county health department.  The

  9  applicant shall be notified in writing of the department's

10  determination and of the applicant's rights to pursue a

11  variance or seek review under the provisions of chapter 120.

12         4.  The owner of an engineer-designed performance-based

13  system must obtain an annual system operating permit from the

14  department.  The department shall inspect the system at least

15  annually and may collect system-effluent samples if

16  appropriate to determine compliance with the performance

17  criteria. The fee for the annual operating permit shall be

18  collected beginning with the second year of system operation.

19         5.  If an engineer-designed system fails to properly

20  function or fails to meet performance standards, the system

21  shall be re-engineered, if necessary, to bring the system into

22  compliance with the provisions of this section.

23         (k)  An innovative system may be approved in

24  conjunction with an engineer-designed site-specific system

25  which is certified by the engineer to meet the

26  performance-based criteria adopted by the department.

27         (l)  For the Florida Keys, the department shall adopt a

28  special rule for the construction, installation, modification,

29  operation, repair, maintenance, and performance of onsite

30  sewage treatment and disposal systems which considers the

31  unique soil conditions and which considers water table

                                  29

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  1  elevations, densities, and setback requirements.  On lots

  2  where a setback distance of 75 feet from surface waters,

  3  saltmarsh, and buttonwood association habitat areas cannot be

  4  met, an injection well, approved and permitted by the

  5  department, may be used for disposal of effluent from onsite

  6  sewage treatment and disposal systems.

  7         (m)  No product sold in the state for use in onsite

  8  sewage treatment and disposal systems may contain any

  9  substance in concentrations or amounts that would interfere

10  with or prevent the successful operation of such system, or

11  that would cause discharges from such systems to violate

12  applicable water quality standards. The department shall

13  publish criteria for products known or expected to meet the

14  conditions of this paragraph. In the event a product does not

15  meet such criteria, such product may be sold if the

16  manufacturer satisfactorily demonstrates to the department

17  that the conditions of this paragraph are met.

18         (n)  Evaluations for determining the seasonal

19  high-water table elevations or the suitability of soils for

20  the use of a new onsite sewage treatment and disposal system

21  shall be performed by department personnel, professional

22  engineers registered in the state, or such other persons with

23  expertise, as defined by rule, in making such evaluations.

24  Evaluations for determining mean annual flood lines shall be

25  performed by those persons identified in paragraph (2)(i). The

26  department shall accept evaluations submitted by professional

27  engineers and such other persons as meet the expertise

28  established by this section or by rule unless the department

29  has a reasonable scientific basis for questioning the accuracy

30  or completeness of the evaluation.

31

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  1         (o)  The department shall appoint a research review and

  2  advisory committee, which shall meet at least semiannually.

  3  The committee shall advise the department on directions for

  4  new research, review and rank proposals for research

  5  contracts, and review draft research reports and make

  6  comments.  The committee is comprised of:

  7         1.  A representative of the Division of Environmental

  8  Health of the Department of Health.

  9         2.  A representative from the septic tank industry.

10         3.  A representative from the home building industry.

11         4.  A representative from an environmental interest

12  group.

13         5.  A representative from the State University System,

14  from a department knowledgeable about onsite sewage treatment

15  and disposal systems.

16         6.  A professional engineer registered in this state

17  who has work experience in onsite sewage treatment and

18  disposal systems.

19         7.  A representative from the real estate profession.

20         8.  A representative from the restaurant industry.

21         9.  A consumer.

22

23  Members shall be appointed for a term of 3 years, with the

24  appointments being staggered so that the terms of no more than

25  four members expire in any one year.  Members shall serve

26  without remuneration, but are entitled to reimbursement for

27  per diem and travel expenses as provided in s. 112.061.

28         (p)  An application for an onsite sewage treatment and

29  disposal system permit shall be completed in full, signed by

30  the owner or the owner's authorized representative, or by a

31  contractor licensed under chapter 489, and shall be

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  1  accompanied by all required exhibits and fees. No specific

  2  documentation of property ownership shall be required as a

  3  prerequisite to the review of an application or the issuance

  4  of a permit.  The issuance of a permit does not constitute

  5  determination by the department of property ownership.

  6         (q)  The department may not require any form of

  7  subdivision analysis of property by an owner, developer, or

  8  subdivider prior to submission of an application for an onsite

  9  sewage treatment and disposal system.

10         (r)  Nothing in this section limits the power of a

11  municipality or county to enforce other laws for the

12  protection of the public health and safety.

13         (s)  In the siting of onsite sewage treatment and

14  disposal systems, including drainfields, shoulders, and

15  slopes, guttering shall not be required on single-family

16  residential dwelling units for systems located greater than 5

17  feet from the roof drip line of the house.  If guttering is

18  used on residential dwelling units, the downspouts shall be

19  directed away from the drainfield.

20         (t)  Notwithstanding the provisions of subparagraph

21  (f)1., onsite sewage treatment and disposal systems located in

22  floodways of the Suwannee and Aucilla Rivers must adhere to

23  the following requirements:

24         1.  The absorption surface of the drainfield shall not

25  be subject to flooding based on 10-year flood elevations.

26  Provided, however, for lots or parcels created by the

27  subdivision of land in accordance with applicable local

28  government regulations prior to January 17, 1990, if an

29  applicant cannot construct a drainfield system with the

30  absorption surface of the drainfield at an elevation equal to

31  or above 10-year flood elevation, the department shall issue a

                                  32

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  1  permit for an onsite sewage treatment and disposal system

  2  within the 10-year floodplain of rivers, streams, and other

  3  bodies of flowing water if all of the following criteria are

  4  met:

  5         a.  The lot is at least one-half acre in size;

  6         b.  The bottom of the drainfield is at least 36 inches

  7  above the 2-year flood elevation; and

  8         c.  The applicant installs either:  a waterless,

  9  incinerating, or organic waste composting toilet and a

10  graywater system and drainfield in accordance with department

11  rules; an aerobic treatment unit and drainfield in accordance

12  with department rules; a system approved by the State Health

13  Office that is capable of reducing effluent nitrate by at

14  least 50 percent; or a system approved by the county health

15  department pursuant to department rule other than a system

16  using alternative drainfield materials.  The United States

17  Department of Agriculture Soil Conservation Service soil maps,

18  State of Florida Water Management District data, and Federal

19  Emergency Management Agency Flood Insurance maps are resources

20  that shall be used to identify flood-prone areas.

21         2.  The use of fill or mounding to elevate a drainfield

22  system out of the 10-year floodplain of rivers, streams, or

23  other bodies of flowing water shall not be permitted if such a

24  system lies within a regulatory floodway of the Suwannee and

25  Aucilla Rivers.  In cases where the 10-year flood elevation

26  does not coincide with the boundaries of the regulatory

27  floodway, the regulatory floodway will be considered for the

28  purposes of this subsection to extend at a minimum to the

29  10-year flood elevation.

30         Section 11.  Paragraph (a) of subsection (2) of section

31  381.0072, Florida Statutes, is amended to read:

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  1         381.0072  Food service protection.--It shall be the

  2  duty of the Department of Health to adopt and enforce

  3  sanitation rules consistent with law to ensure the protection

  4  of the public from food-borne illness. These rules shall

  5  provide the standards and requirements for the storage,

  6  preparation, serving, or display of food in food service

  7  establishments as defined in this section and which are not

  8  permitted or licensed under chapter 500 or chapter 509.

  9         (2)  DUTIES.--

10         (a)  The department shall adopt rules, including

11  definitions of terms which are consistent with law prescribing

12  minimum sanitation standards and manager certification

13  requirements as prescribed in s. 509.039, and which shall be

14  enforced in food service establishments as defined in this

15  section. The sanitation standards must address the

16  construction, operation, and maintenance of the establishment;

17  lighting, ventilation, laundry rooms, lockers, use and storage

18  of toxic materials and cleaning compounds, and first-aid

19  supplies; plan review; design, construction, installation,

20  location, maintenance, sanitation, and storage of food

21  equipment and utensils; employee training, health, hygiene,

22  and work practices; food supplies, preparation, storage,

23  transportation, and service, including access to the areas

24  where food is stored or prepared; and sanitary facilities and

25  controls, including water supply and sewage disposal; plumbing

26  and toilet facilities; garbage and refuse collection, storage,

27  and disposal; and vermin control. Public and private schools,

28  hospitals licensed under chapter 395, nursing homes licensed

29  under part II of chapter 400, child care facilities as defined

30  in s. 402.301, and residential facilities colocated with a

31  nursing home or hospital if all food is prepared in a central

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  1  kitchen that complies with nursing or hospital regulations

  2  shall be exempt from the rules developed for manager

  3  certification. The department shall administer a comprehensive

  4  inspection, monitoring, and sampling program to ensure such

  5  standards are maintained. With respect to food service

  6  establishments permitted or licensed under chapter 500 or

  7  chapter 509, the department shall assist the Division of

  8  Hotels and Restaurants of the Department of Business and

  9  Professional Regulation and the Department of Agriculture and

10  Consumer Services with rulemaking by providing technical

11  information.

12         Section 12.  Subsection (1) of section 381.0086,

13  Florida Statutes, is amended to read:

14         381.0086  Rules; variances; penalties.--

15         (1)  The department shall adopt rules necessary to

16  protect the health and safety of migrant farm workers and

17  other migrant labor camp or residential migrant housing

18  occupants, including rules governing field-sanitation

19  facilities.  These rules must include definitions of terms,

20  provisions relating to plan review of the construction of new,

21  expanded, or remodeled camps, sites, buildings and structures,

22  personal hygiene facilities, lighting, sewage disposal,

23  safety, minimum living space per occupant, bedding, food

24  equipment, food storage and preparation, insect and rodent

25  control, garbage, heating equipment, water supply, maintenance

26  and operation of the camp, housing, or roads, and such other

27  matters as the department finds to be appropriate or necessary

28  to protect the life and health of the occupants.  Housing

29  operated by a public housing authority is exempt from the

30  provisions of any administrative rule that conflicts with or

31

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  1  is more stringent than the federal standards applicable to the

  2  housing.

  3         Section 13.  Subsections (3), (4), and (5) of section

  4  381.0098, Florida Statutes, are amended to read:

  5         381.0098  Biomedical waste.--

  6         (3)  OPERATING STANDARDS.--The department shall adopt

  7  rules necessary to protect the health, safety, and welfare of

  8  the public and to carry out the purpose of this section.  Such

  9  rules shall address, but need not be limited to, definitions

10  of terms, the packaging of biomedical waste, including

11  specific requirements for the segregation of the waste at the

12  point of generation; the safe packaging of sharps; the

13  placement of the waste in containers that will protect waste

14  handlers and the public from exposure; the appropriate

15  labeling of containers of waste; written operating plans for

16  managing biomedical waste; and the transport, storage, and

17  treatment of biomedical wastes.

18         (4)  PERMITS AND FEES.--

19         (a)  All persons who generate, store, or treat

20  biomedical waste shall obtain a permit from the department

21  prior to commencing operation, except that a biomedical waste

22  generator generating less than 25 pounds of biomedical waste

23  in each 30-day period shall be exempt from the registration

24  and fee requirements of this subsection.  A biomedical waste

25  generator need not obtain a separate permit if such generator

26  works less than 6 hours in a 7-day period at a location

27  different than the location specified on the permit.  The

28  department may issue combined permits for generation, storage,

29  and treatment as appropriate to streamline permitting

30  procedures.  Application for such permit shall be made on an

31

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  1  application form provided by the department and within the

  2  timeframes and in the manner prescribed by department rule.

  3         (b)  Once the department determines that the person

  4  generating, storing, or treating biomedical waste is capable

  5  of constructing a facility or operating in compliance with

  6  this section and the rules adopted under this section, the

  7  department shall grant the permit.

  8         (c)  If the department determines that the person

  9  generating, storing, or treating biomedical waste does not

10  meet the provisions outlined in this section or the rules

11  adopted under this section, the department shall deny the

12  application for the permit pursuant to provisions of chapter

13  120.  Such denial shall be in writing and shall list the

14  circumstances for denial.  Upon correction of such

15  circumstances the permit shall be issued.

16         (d)  The permit for a biomedical waste facility may

17  generator shall not be transferred from one owner to another.

18  When the ownership, control, or name of a biomedical waste

19  facility generator is changed and continues to operate, the

20  new owner shall apply to the department, upon forms provided

21  by the department, for issuance of a permit in the timeframe

22  and manner prescribed by rule of the department.

23         (e)  A permit which the department may require by rule,

24  for the storage or treatment of biomedical waste, may not be

25  transferred by the permittee to any other entity, except in

26  conformity with the requirements of this paragraph.

27         1.  Within 30 days after the sale or legal transfer of

28  a permitted facility, the permittee shall file with the

29  department an application for transfer of a permit on such

30  form as the department shall establish by rule. The form must

31

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  1  be completed with the notarized signatures of both the

  2  transferring permittee and the proposed permittee.

  3         2.  The department shall approve the transfer of a

  4  permit unless it determines that the proposed permittee has

  5  not provided reasonable assurances that the proposed permittee

  6  has the administrative, technical, and financial capability to

  7  properly satisfy the requirements and conditions of the

  8  permit, as determined by department rule.  The determination

  9  shall be limited solely to the ability of the proposed

10  permittee to comply with the conditions of the existing

11  permit, and it shall not concern the adequacy of the permit

12  conditions. If the department proposes to deny the transfer,

13  it shall provide both the transferring permittee and the

14  proposed permittee a written objection to such transfer

15  together with notice of a right to request a proceeding on

16  such determination under chapter 120.

17         3.  Within 90 days after receiving a properly completed

18  application for transfer of a permit, the department shall

19  issue a final determination. The department may toll the time

20  for making a determination on the transfer by notifying both

21  the transferring permittee and the proposed permittee that

22  additional information is required to adequately review the

23  transfer request. Such notification shall be provided within

24  30 days after receipt of an application for transfer of the

25  permit, completed pursuant to this paragraph. If the

26  department fails to take action to approve or deny the

27  transfer within 90 days after receipt of the completed

28  application or within 90 days after receipt of the last item

29  of timely requested additional information, the transfer shall

30  be deemed approved.

31

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  1         4.  The transferring permittee is encouraged to apply

  2  for a permit transfer well in advance of the sale or legal

  3  transfer of a permitted facility.  However, the transfer of

  4  the permit shall not be effective prior to the sale or legal

  5  transfer of the facility.

  6         5.  Until the transfer of the permit is approved by the

  7  department, the transferring permittee and any other person

  8  constructing, operating, or maintaining the permitted facility

  9  shall be liable for compliance with the terms of the permit.

10  Nothing in this section shall relieve the transferring

11  permittee of liability for corrective actions that may be

12  required as a result of any violations occurring prior to the

13  legal transfer of the permit.

14         (e)(f)  The department shall establish a schedule of

15  fees for such permits. Fees assessed under this section shall

16  be in an amount sufficient to meet the costs of carrying out

17  the provisions of this section and rules adopted under this

18  section.  The fee schedule shall not be less than $50 or more

19  than $400 for each year the permit is valid.  Fees may be

20  prorated on a quarterly basis when a facility will be in

21  operation for 6 months or less before the annual renewal date.

22  The department shall assess the minimum fees provided in this

23  subsection until a fee schedule is adopted promulgated by rule

24  of the department.  Facilities owned and operated by the state

25  shall be exempt from the payment of any fees.

26         (f)(g)  Fees collected by the department in accordance

27  with provisions of this section and the rules adopted under

28  this section shall be deposited into a trust fund administered

29  by the department for the payment of costs incurred in the

30  administration of this section.

31

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  1         (g)(h)  Permits issued by the department shall be valid

  2  for no more than 5 years.  However, upon expiration, a new

  3  permit may be issued by the department in accordance with this

  4  section and the rules of the department.

  5         (h)(i)  The department may is authorized to develop a

  6  streamlined process for permitting biomedical waste storage

  7  facilities that accept and store only sharps collected from

  8  the public, which may include the issuance of a single permit

  9  for each applicant that which develops or sponsors a sharps

10  collection program.

11         (5)  TRANSPORTERS.--Any person who transports

12  biomedical waste within the state must register with the

13  department prior to engaging in the transport of biomedical

14  waste in accordance with rules adopted promulgated by the

15  department.  A registration may not be transferred from one

16  biomedical waste transporter to another. If the ownership or

17  name of a biomedical waste transporter is changed and the

18  owner intends to continue operation of the transporter, the

19  owner must apply to the department on departmental forms

20  within the timeframes and in the manner prescribed by

21  department rule. The department may charge registration fees

22  in the same manner as is provided in paragraphs (4)(e) and (f)

23  (4)(f) and (g).  The department may exempt from this

24  requirement any person who, or facility that, transports less

25  than 25 pounds of such waste on any single occasion.

26         Section 14.  Subsection (5) of section 381.0101,

27  Florida Statutes, is amended to read:

28         381.0101  Environmental health professionals.--

29         (5)  STANDARDS FOR CERTIFICATION.--The department shall

30  adopt rules that establish definitions of terms and minimum

31  standards of education, training, or experience for those

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  1  persons subject to this section. The rules must shall also

  2  address the process for application, examination, issuance,

  3  expiration, and renewal of certification and ethical standards

  4  of practice for the profession.

  5         (a)  Persons employed as environmental health

  6  professionals shall exhibit a knowledge of rules and

  7  principles of environmental and public health law in Florida

  8  through examination.  A person may not conduct environmental

  9  health evaluations in a primary program area unless he or she

10  is currently certified in that program area or works under the

11  direct supervision of a certified environmental health

12  professional.

13         1.  All persons who begin employment in a primary

14  environmental health program on or after September 21, 1994,

15  must be certified in that program within 6 months after

16  employment.

17         2.  Persons employed in a primary environmental health

18  program prior to September 21, 1994, shall be considered

19  certified while employed in that position and shall be

20  required to adhere to any professional standards established

21  by the department pursuant to paragraph (b), complete any

22  continuing education requirements imposed under paragraph (d),

23  and pay the certificate renewal fee imposed under subsection

24  (7).

25         3.  Persons employed in a primary environmental health

26  program prior to September 21, 1994, who change positions or

27  program areas and transfer into another primary environmental

28  health program area on or after September 21, 1994, must be

29  certified in that program within 6 months after such transfer,

30  except that they will not be required to possess the college

31  degree required under paragraph (e).

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  1         4.  Registered sanitarians shall be considered

  2  certified and shall be required to adhere to any professional

  3  standards established by the department pursuant to paragraph

  4  (b).

  5         (b)  At a minimum, the department shall establish

  6  standards for professionals in the areas of food hygiene and

  7  onsite sewage treatment and disposal.

  8         (c)  Those persons conducting primary environmental

  9  health evaluations shall be certified by examination to be

10  knowledgeable in any primary area of environmental health in

11  which they are routinely assigned duties.

12         (d)  Persons who are certified shall renew their

13  certification biennially by completing not less than 24

14  contact hours of continuing education for each program area in

15  which they maintain certification.

16         (e)  Applicants for certification shall have graduated

17  from an accredited 4-year college or university with a degree

18  or major coursework in public health, environmental health,

19  environmental science, or a physical or biological science.

20         (f)  A certificateholder shall notify the department

21  within 60 days after any change of name or address from that

22  which appears on the current certificate.

23         Section 15.  Subsection (1) of section 381.0203,

24  Florida Statutes, is amended to read:

25         381.0203  Pharmacy services.--

26         (1)  The department may contract on a statewide basis

27  for the purchase of drugs, as defined in s. 499.003, to be

28  used by state agencies and political subdivisions, and may

29  adopt rules to administer this section.

30         Section 16.  Subsections (12) and (13) of section

31  381.89, Florida Statutes, are amended to read:

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  1         381.89  Regulation of tanning facilities.--

  2         (12)  The department may institute legal action for

  3  injunctive or other relief to enforce this section. If a

  4  tanning facility or other person violates this section or any

  5  rule adopted under this section, the department may issue a

  6  stop-use order, as prescribed by rule, to remove a tanning

  7  device from service.

  8         (13)  The department shall adopt rules to administer

  9  implement this section. The rules may include, but need not be

10  limited to, requirements for training tanning facility

11  operators and employees; definitions of terms; the approval of

12  training courses; safety; plan review; and the design,

13  construction, operation, maintenance, and cleanliness of

14  tanning facilities and tanning devices.

15         Section 17.  Paragraph (a) of subsection (2) of section

16  383.011, Florida Statutes, is amended to read:

17         383.011  Administration of maternal and child health

18  programs.--

19         (2)  The Department of Health shall follow federal

20  requirements and may adopt any rules necessary for the

21  implementation of the maternal and child health care program,

22  the WIC program, and the Child Care Food Program.

23         (a)  The department may adopt rules that are necessary

24  to administer the maternal and child health care program. The

25  rules may include, but need not be limited to, requirements

26  for client eligibility, program standards, service delivery,

27  system responsibilities of county health departments and

28  system assurance for healthy start coalitions, care

29  coordination, enhanced services, quality assurance, and

30  provider selection. The rules may also include provisions for

31  the identification, screening, and intervention efforts by

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  1  health care providers prior to and following the birth of a

  2  child and responsibilities for the interprogram coordination

  3  of prenatal and infant care coalitions.

  4         Section 18.  Subsection (2) of section 383.14, Florida

  5  Statutes, is amended to read:

  6         383.14  Screening for metabolic disorders, other

  7  hereditary and congenital disorders, and environmental risk

  8  factors.--

  9         (2)  RULES.--After consultation with the Genetics and

10  Infant Screening Advisory Council, the department shall adopt

11  and enforce rules requiring that every infant born in this

12  state shall, prior to becoming 2 weeks of age, be subjected to

13  a test for phenylketonuria and, at the appropriate age, be

14  tested for such other metabolic diseases and hereditary or

15  congenital disorders as the department may deem necessary from

16  time to time. After consultation with the State Coordinating

17  Council for Early Childhood Services, the department shall

18  also adopt and enforce rules requiring every infant born in

19  this state to be screened for environmental risk factors that

20  place children and their families at risk for increased

21  morbidity, mortality, and other negative outcomes.  The

22  department shall adopt such additional rules as are found

23  necessary for the administration of this section, including

24  rules providing definitions of terms, rules relating to the

25  methods used and time or times for testing as accepted medical

26  practice indicates, rules relating to charging and collecting

27  fees for screenings authorized by this section, and rules

28  requiring mandatory reporting of the results of tests and

29  screenings for these conditions to the department.

30         Section 19.  Subsection (1) of section 383.19, Florida

31  Statutes, is amended to read:

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  1         383.19  Standards; funding; ineligibility.--

  2         (1)  The department shall adopt rules that specify

  3  standards for development and operation of a center which

  4  include, but are not limited to:

  5         (a)  The need to provide services through a regional

  6  perinatal intensive care center and the requirements of the

  7  population to be served.

  8         (b)  Equipment.

  9         (c)  Facilities.

10         (d)  Staffing and qualifications of personnel.

11         (e)  Transportation services.

12         (f)  Data collection.

13         (g)  Definitions of terms.

14         Section 20.  Subsections (9) and (10) of section

15  383.216, Florida Statutes, are amended to read:

16         383.216  Community-based prenatal and infant health

17  care.--

18         (9)  Local prenatal and infant health care coalitions

19  shall incorporate as not-for-profit corporations for the

20  purpose of seeking and receiving grants from federal, state,

21  and local government and other contributors. However, a

22  coalition need not be designated as a tax-exempt organization

23  under s. 501(c)(3) of the Internal Revenue Code.

24         (10)  The Department of Health shall adopt rules as

25  necessary to administer implement this section, including

26  rules defining acceptable "in-kind" contributions and rules

27  providing definitions of terms, coalition responsibilities,

28  coalition operations and standards, and conditions for

29  establishing and approving a coalition. A coalition may not be

30  a direct provider of prenatal and infant-care services.

31

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  1         Section 21.  Section 384.33, Florida Statutes, is

  2  amended to read:

  3         384.33  Rules.--The department may adopt rules pursuant

  4  to ss. 120.536(1) and 120.54 to implement the provisions of

  5  this chapter. The rules may include requirements for methods

  6  of contacting a physician to determine the need for followup

  7  services related to sexually transmissible diseases; standards

  8  for screening, treating, and performing contact investigations

  9  to control the spread of sexually transmitted diseases; and

10  requirements for maintaining the security of confidential

11  information.

12         Section 22.  Subsection (4) of section 385.207, Florida

13  Statutes, is amended to read:

14         385.207  Care and assistance of persons with epilepsy;

15  establishment of programs in epilepsy control.--

16         (4)  The department shall adopt rules to administer

17  implement this section. The rules may include requirements for

18  the scope of service, criteria for eligibility, and

19  requirements for reports and forms.

20         Section 23.  Subsection (18) of section 391.026,

21  Florida Statutes, is amended to read:

22         391.026  Powers and duties of the department.--The

23  department shall have the following powers, duties, and

24  responsibilities:

25         (18)  To adopt rules pursuant to ss. 120.536(1) and

26  120.54 to administer implement the Children's Medical Services

27  provisions of this Act. The rules may include requirements for

28  definitions of terms, program organization, and program

29  description; a process for selecting an area medical director;

30  responsibilities of applicants and clients; requirements for

31  service applications, including required medical and financial

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  1  information; eligibility requirements for initial treatment

  2  and for continued eligibility, including financial and custody

  3  issues; methodologies for resource development and allocation,

  4  including medical and financial considerations; requirements

  5  for reimbursement services rendered to a client; billing and

  6  payment requirements for providers; requirements for

  7  qualification, appointments, verification, and emergency

  8  exceptions for health-professional consultants; general and

  9  diagnostic-specific standards for diagnostic and treatment

10  facilities; and standards for the method of service delivery,

11  including consultant services, respect-for-privacy

12  considerations, examination requirements, family support

13  plans, and clinic design.

14         Section 24.  Section 392.66, Florida Statutes, is

15  amended to read:

16         392.66  Rules.--The department shall adopt rules

17  pursuant to ss. 120.536(1) and 120.54 to administer implement

18  the provisions of this chapter. The rules must include

19  requirements for tuberculosis treatment and provide

20  consequences if a person who has active tuberculosis fails to

21  comply with treatment requirements.

22         Section 25.  Subsection (2) of section 395.401, Florida

23  Statutes, is amended to read:

24         395.401  Trauma services system plans; verification of

25  trauma centers and pediatric trauma referral centers;

26  procedures; renewal.--

27         (2)(a)  The local and regional trauma agencies shall

28  plan, implement, and evaluate trauma services systems, in

29  accordance with this section and ss. 395.4015, 395.404, and

30  395.4045, which consist of organized patterns of readiness and

31  response services based on public and private agreements and

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  1  operational procedures. The department shall establish, by

  2  rule, processes and procedures for establishing a trauma

  3  agency and obtaining its approval from the department.

  4         (b)  The local and regional trauma agencies shall

  5  develop and submit to the department plans for local and

  6  regional trauma services systems. The plans must include, at a

  7  minimum, the following components:

  8         1.  The organizational structure of the trauma system.

  9         2.  Prehospital care management guidelines for triage

10  and transportation of trauma cases.

11         3.  Flow patterns of trauma cases and transportation

12  system design and resources, including air transportation

13  services, and provision for interfacility transfer.

14         4.  The number and location of needed state-approved

15  trauma centers based on local needs, population, and location

16  and distribution of resources.

17         5.  Data collection regarding system operation and

18  patient outcome.

19         6.  Periodic performance evaluation of the trauma

20  system and its components.

21         7.  The use of air transport services within the

22  jurisdiction of the local trauma agency.

23         8.  Public information and education about the trauma

24  system.

25         9.  Emergency medical services communication system

26  usage and dispatching.

27         10.  The coordination and integration between the

28  verified trauma care facility and the nonverified health care

29  facilities.

30         11.  Medical control and accountability.

31         12.  Quality control and system evaluation.

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  1         (c)  The department shall receive plans for the

  2  implementation of inclusive trauma systems from trauma

  3  agencies.  The department may approve or not approve trauma

  4  agency plans based on the conformance of the plan with this

  5  section and ss. 395.4015, 395.404, and 395.4045 and the rules

  6  and definitions adopted by the department pursuant to those

  7  sections.  The department shall approve or disapprove the

  8  plans within 120 days after the date the plans are submitted

  9  to the department. The department shall, by rule, provide an

10  application process for establishing a trauma agency. The

11  application must, at a minimum, provide requirements for the

12  trauma agency plan submitted for review, a process for

13  reviewing the application for a state-approved trauma agency,

14  a process for reviewing the trauma transport protocols for the

15  trauma agency, and a process for reviewing the staffing

16  requirements for the agency. The department shall, by rule,

17  establish minimum requirements for a trauma agency to conduct

18  an annual performance evaluation and submit the results to the

19  department.

20         (d)  A trauma agency shall not operate unless the

21  department has approved the local or regional trauma services

22  system plan of the agency.

23         (e)  The department may grant an exception to a portion

24  of the rules adopted pursuant to this section or s. 395.4015

25  if the local or regional trauma agency proves that, as defined

26  in the rules, compliance with that requirement would not be in

27  the best interest of the persons served within the affected

28  local or regional trauma area.

29         (f)  A local or regional trauma agency may implement a

30  trauma care system only if the system meets the minimum

31  standards set forth in the rules for implementation

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  1  established by the department and if the plan has been

  2  submitted to, and approved by, the department.  At least 60

  3  days before the local or regional trauma agency submits the

  4  plan for the trauma care system to the department, the local

  5  or regional trauma agency shall hold a public hearing and give

  6  adequate notice of the public hearing to all hospitals and

  7  other interested parties in the area to be included in the

  8  proposed system.

  9         (g)  Local or regional trauma agencies may enter into

10  contracts for the purpose of implementing the local or

11  regional plan.  If local or regional agencies contract with

12  hospitals for trauma services, such agencies must contract

13  only with hospitals which are verified trauma centers.

14         (h)  Local or regional trauma agencies providing

15  service for more than one county shall, as part of their

16  formation, establish interlocal agreements between or among

17  the several counties in the regional system.

18         (i)  This section does not restrict the authority of a

19  health care facility to provide service for which it has

20  received a license pursuant to this chapter.

21         (j)  Any hospital which is verified as a trauma center

22  shall accept all trauma victims that are appropriate for the

23  facility regardless of race, sex, creed, or ability to pay.

24         (k)  It is unlawful for any hospital or other facility

25  to hold itself out as a trauma center unless it has been so

26  verified.

27         (l)  A county, upon the recommendations of the local or

28  regional trauma agency, may adopt ordinances governing the

29  transport of a patient who is receiving care in the field from

30  prehospital emergency medical personnel when the patient meets

31  specific criteria for trauma, burn, or pediatric centers

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  1  adopted by the local or regional trauma agency.  These

  2  ordinances must be consistent with s. 395.4045, ordinances

  3  adopted under s. 401.25(6), and the local or regional trauma

  4  system plan and, to the furthest possible extent, must ensure

  5  that individual patients receive appropriate medical care

  6  while protecting the interests of the community at large by

  7  making maximum use of available emergency medical care

  8  resources.

  9         (m)  The local or regional trauma agency shall,

10  consistent with the regional trauma system plan, coordinate

11  and otherwise facilitate arrangements necessary to develop a

12  trauma services system.

13         (n)  After the submission of the initial trauma system

14  plan, each trauma agency shall, every 5th year, submit to the

15  department for approval an updated plan that identifies the

16  changes, if any, to be made in the regional trauma system.

17         (o)  This section does not preclude a local or regional

18  trauma agency from adopting trauma care system standards.

19         Section 26.  Paragraph (b) of subsection (3) of section

20  395.402, Florida Statutes, is amended to read:

21         395.402  Trauma service areas; number and location of

22  trauma centers.--

23         (3)  Trauma service areas are to be used. The

24  department shall periodically review the assignment of the 67

25  counties to trauma service areas. These assignments are made

26  for the purpose of developing a system of trauma centers.

27  Revisions made by the department should take into

28  consideration the recommendations made as part of the regional

29  trauma system plans approved by the department, as well as the

30  recommendations made as part of the state trauma system plan.

31  These areas must, at a minimum, be reviewed in the year 2000

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  1  and every 5 years thereafter. Until the department completes

  2  its initial review, the assignment of counties shall remain as

  3  established pursuant to chapter 90-284, Laws of Florida.

  4         (b)  Each trauma service area should have at least one

  5  Level I or Level II trauma center. The department shall

  6  allocate, by rule, the number of trauma centers needed for

  7  each trauma service area.

  8         Section 27.  Section 401.35, Florida Statutes, is

  9  amended to read:

10         401.35  Rules.--The department shall adopt rules,

11  including definitions of terms, necessary to carry out the

12  purposes of this part.

13         (1)  The rules must provide at least minimum standards

14  governing:

15         (a)  Sanitation, safety, and maintenance of basic life

16  support and advanced life support vehicles and air ambulances.

17         (b)  Emergency medical technician, paramedic, and

18  driver training and qualifications.

19         (c)  Ground ambulance and vehicle equipment and

20  supplies at least as comprehensive as those published in the

21  most current edition of the American College of Surgeons,

22  Committee on Trauma, list of essential equipment for

23  ambulances, as interpreted by rules of the department.

24         (d)  Ground ambulance or vehicle design and

25  construction at least equal to those most currently

26  recommended by the United States General Services

27  Administration as interpreted by rules of the department.

28         (e)  Staffing of basic life support and advanced life

29  support vehicles.

30         (f)  Two-way communications for basic life support

31  services and advanced life support services.

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  1         (g)  Advanced life support services equipment.

  2         (h)  Programs of training for emergency medical

  3  technicians and paramedics.

  4         (i)  Vehicles, equipment, communications, and minimum

  5  staffing qualifications for air ambulance services.

  6         (j)  Ambulance driver qualifications, training, and

  7  experience.

  8         (k)  Optional use of telemetry by licensees.

  9         (l)  Licensees' security and storage of controlled

10  substances, medications, and fluids, not inconsistent with the

11  provisions of chapter 499 or chapter 893.

12         (2)  The rules must establish application requirements

13  for licensure and certification.  Pursuant thereto, the

14  department must develop application forms for basic life

15  support services and advanced life support services.  An

16  application for each respective service license must include,

17  but is not limited to:

18         (a)  The name and business address of the operator and

19  owner of the service or proposed service.

20         (b)  The name under which the applicant will operate.

21         (c)  A list of the names and addresses of all officers,

22  directors, and shareholders of the applicant.

23         (d)  A description of each vehicle to be used,

24  including the make, model, year of manufacture, mileage, and

25  vehicle identification number (VIN); the state or federal

26  aviation or marine registration number, when applicable; and

27  the color scheme, insignia, name, monogram, or other

28  distinguishing characteristics to be used to designate the

29  applicant's vehicle or vehicles.

30         (e)  The service location from which the service will

31  operate.

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  1         (f)  A statement reasonably describing the geographic

  2  area or areas to be served by the applicant.

  3         (g)  A statement certifying that the applicant will

  4  provide continuous service 24 hours a day, 7 days a week, if a

  5  basic life support service license or an advanced life support

  6  service license is sought.  Such service must be initiated

  7  within 30 days after issuance of the license.

  8         (h)  Such other information as the department

  9  determines reasonable and necessary.

10         (i)  An oath, upon forms provided by the department

11  which shall contain such information as the department

12  reasonably requires, which may include affirmative evidence of

13  ability to comply with applicable laws and rules.

14         (3)  The rules must establish specifications regarding

15  insignia and other ambulance identification.  Any fire

16  department may retain its fire department identity and may use

17  such color scheme, insignia, name, monogram, or other

18  distinguishing characteristic that is acceptable to the fire

19  department for the purpose of designating its vehicles as

20  advanced life support vehicles.  However, those advanced life

21  support service/fire rescue vehicles or ambulances operated by

22  fire departments which were purchased in whole or in part with

23  federal funds must comply with federal regulations pertaining

24  to color schemes, emblems, and markings.

25         (4)  The rules must establish circumstances and

26  procedures under which emergency medical technicians and

27  paramedics may honor orders by the patient's physician not to

28  resuscitate and the documentation and reporting requirements

29  for handling such requests.

30         (5)  The rules must establish requirements for

31  licensees and certificateholders with respect to providing

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  1  address information to the department; requirements for

  2  examinations, grading, and passing scores for certification;

  3  and requirements for determining whether a convicted felon

  4  whose civil rights have not been restored is eligible for

  5  certification or recertification.

  6         Section 28.  Paragraph (f) of subsection (1) of section

  7  403.862, Florida Statutes, is amended to read:

  8         403.862  Department of Health; public water supply

  9  duties and responsibilities; coordinated budget requests with

10  department.--

11         (1)  Recognizing that supervision and control of county

12  health departments of the Department of Health is retained by

13  the secretary of that agency, and that public health aspects

14  of the state public water supply program require joint

15  participation in the program by the Department of Health and

16  its units and the department, the Department of Health shall:

17         (f)  Have general supervision and control over all

18  private water systems and all public water systems not

19  otherwise covered or included in this part. This shall include

20  the authority to adopt and enforce rules, including

21  definitions of terms, to protect the health, safety, or

22  welfare of persons being served by all private water systems

23  and all public water systems not otherwise covered by this

24  part.

25         Section 29.  Subsection (3) of section 404.056, Florida

26  Statutes, is amended to read:

27         404.056  Environmental radiation standards and

28  programs; radon protection.--

29         (3)  CERTIFICATION.--

30         (a)  The department may is authorized to certify

31  persons who perform radon gas or radon progeny measurements,

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  1  including sample collection, analysis, or interpretation of

  2  such measurements, and who perform mitigation of buildings for

  3  radon gas or radon progeny, and shall collect a fee for such

  4  certification. Before performing radon measurement or radon

  5  mitigation services, including collecting samples, performing

  6  analysis, or interpreting measurement results, a certified

  7  individual must own, be employed by, or be retained as a

  8  consultant to a certified radon measurement or certified radon

  9  mitigation business. The department may establish criteria for

10  the application, certification, and annual renewal of basic

11  and advanced levels of certification for individuals, which

12  may include requirements for education and experience,

13  approved training, examinations, and reporting. The department

14  may approve training courses for certification and establish

15  criteria for training courses and instructors. The department

16  may observe and evaluate training sessions, instructors, and

17  course material without charge.

18         (b)  A person may not participate in performing radon

19  gas or radon progeny measurements, including sample

20  collection, analysis, or interpretation of such measurements,

21  or perform mitigation of buildings for radon gas or radon

22  progeny, and charge a fee or obtain other remuneration as

23  benefit for such services or devices, unless that person is

24  certified by the department. A certification issued in

25  accordance with this section automatically expires at the end

26  of the certification period stated on the certificate. An

27  uncertified commercial business may subcontract radon

28  measurements to a certified radon business. The uncertified

29  commercial business must provide the complete radon report

30  from the certified radon business to the client and direct all

31

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  1  the client's questions about the measurements or radon report

  2  to the certified radon business.

  3         (c)  The results of measurements of radon gas or radon

  4  progeny performed by persons certified under the provisions of

  5  this subsection shall be reported to the department and

  6  persons contracting for the service.  Upon request, the

  7  results of measurements of radon gas or radon progeny which

  8  are performed to evaluate the effectiveness of a radon

  9  mitigation system shall be reported to the certified business

10  that installed the mitigation system. The report must include

11  the radon levels detected; the location, age, and description

12  of the building; the name and certification numbers of the

13  certified radon measurement business and individual who

14  performed the measurements; and other information determined

15  by the department to meet the requirements of the protocols

16  and procedures for the type of measurement performed. Each

17  installation of a radon mitigation system performed by a

18  person certified under this section must be reported to the

19  department according to the schedule set by the department.

20  The report must include the premitigation and postmitigation

21  radon levels; the type or types of systems installed; the

22  location, age, and description of the building; and the name

23  and certification number of the certified mitigation business

24  that performed the mitigation.

25         (d)  Authorized representatives of the department may

26  have the authority to inspect the business and records of any

27  person certified under the provisions of this subsection, at

28  all reasonable times, to examine records and test procedures

29  to determine compliance with or violation of the provisions of

30  this section.

31

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  1         (e)  Any person who practices fraud, deception, or

  2  misrepresentation in performing radon gas or radon progeny

  3  measurements or in performing mitigation of buildings for

  4  radon gas or radon progeny is subject to the penalties

  5  provided in s. 404.161.

  6         (f)  The department may is authorized to charge and

  7  collect nonrefundable fees for the certification and annual

  8  recertification of persons who perform radon gas or radon

  9  progeny measurements or who perform mitigation of buildings

10  for radon gas or radon progeny. The amount of the initial

11  application fee and certification shall be not less than $200

12  or more than $900.  The amount of the annual recertification

13  fee shall be not less than $200 or more than $900. Effective

14  July 1, 1988, the fee amounts shall be the minimum fee

15  prescribed in this paragraph, and such fee amounts shall

16  remain in effect until the effective date of a fee schedule

17  promulgated by rule by the department.  The fees collected

18  shall be deposited in the Radiation Protection Trust Fund and

19  shall be used only to implement the provisions of this

20  section.  The surcharge established pursuant to subsection (3)

21  may be used to supplement the fees established in this

22  paragraph in carrying out the provisions of this subsection.

23         (g)  The department may establish enforcement

24  procedures; deny an application for initial or renewal

25  certification; deny, suspend, or revoke a certification;, or

26  impose an administrative fine not to exceed $1,000 per

27  violation per day, for the violation of any provision of this

28  section or rule adopted under this section promulgated

29  pursuant thereto.

30         (h)  A certificateholder in good standing remains in

31  good standing when he or she becomes a member of the Armed

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  1  Forces of the United States on active duty without payment of

  2  renewal fees as long as he or she is a member of the Armed

  3  Forces on active duty and for a period of 6 months after his

  4  or her discharge from active duty, if he or she is not engaged

  5  in practicing radon measurement or radon mitigation in the

  6  private sector for profit.  The certificateholder must pay a

  7  renewal fee to renew the certificate.

  8         (i)  A certificateholder who is in good standing

  9  remains in good standing if he or she is absent from the state

10  because of his or her spouse's active duty with the Armed

11  Forces of the United States. The certificateholder remains in

12  good standing without payment of renewal fees as long as his

13  or her spouse is a member of the Armed Forces on active duty

14  and for a period of 6 months after the spouse's discharge from

15  active duty, if the certificateholder is not engaged in

16  practicing radon measurement or radon mitigation in the

17  private sector for profit.  The certificateholder must pay a

18  renewal fee to renew the certificate.

19         (j)  The department may set criteria and requirements

20  for the application, certification, and annual renewal of

21  certification for radon measurement and mitigation businesses,

22  which may include:

23         1.  Requirements for measurement devices and

24  measurement procedures, including the disclosure of mitigation

25  materials, systems, and other mitigation services offered.

26         2.  The identification of certified specialists and

27  technicians employed by the business and requirements for

28  specialist staffing and duties.

29         3.  The analysis of measurement devices by proficient

30  analytical service providers.

31

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  1         4.  Requirements for a quality assurance and quality

  2  control program.

  3         5.  The disclosure of client measurement reporting

  4  forms and warranties and operating instructions for mitigation

  5  systems.

  6         6.  Requirements for radon services publications and

  7  the identification of the radon business certification number

  8  in advertisements.

  9         7.  Requirements for a worker health and safety

10  program.

11         8.  Requirements for maintaining radon records.

12         9.  The operation of branch office locations.

13         10.  Requirements for supervising subcontractors who

14  install mitigation systems.

15         11.  Requirements for building inspections and

16  evaluation and standards for the design and installation of

17  mitigation systems.

18         12.  Prescribing conditions of premitigation and

19  postmitigation mitigation measurements.

20         13.  Requirements for renewals received after the

21  automatic expiration date of certification.

22         14.  Requirements for obtaining a duplicate or

23  replacement certificate, including a fee not to exceed the

24  cost of producing the duplicate or replacement certificate.

25         15.  Requirements for reporting, including timeframes

26  and content.

27         (k)  Any change in the information provided to the

28  department in the original business application to be reported

29  within 10 days after the change.

30         Section 30.  Subsection (1) of section 404.22, Florida

31  Statutes, is amended to read:

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  1         404.22  Radiation machines and components;

  2  inspection.--

  3         (1)  The department and its duly authorized agents may

  4  inspect in a lawful manner at all reasonable hours any

  5  hospital or other health care facility or other place in the

  6  state in which a radiation machine is installed for the

  7  purpose of determining whether the facility, the radiation

  8  machine and its components, the film and film processing

  9  equipment, the techniques and procedures, any mechanical

10  holding devices, the warning labels and signs, the written

11  safety procedures, and the resultant image produced meet the

12  standards of the department as set forth in this chapter and

13  rules adopted pursuant to this chapter thereto. Such rules may

14  include standards for radiation machine performance, surveys,

15  calibrations, and spot checks; requirements for quality

16  assurance programs and quality control programs; standards for

17  facility electrical systems, safety alarms,

18  radiation-monitoring equipment, and dosimetry systems;

19  requirements for visual and aural communication with patients;

20  procedures for establishing radiation-safety committees for a

21  facility; and qualifications of persons who cause a radiation

22  machine to be used, who operate a radiation machine, and who

23  ensure that a radiation machine complies with the requirements

24  of this chapter and with rules of the department. If, in the

25  opinion of the department, a radiation machine that which

26  fails to meet such standards can be made to meet the standards

27  through an adjustment or limitation upon the stations or range

28  of the radiation machine or through the purchase of a

29  component meeting the standards, the department shall order

30  the owner of the radiation machine to make the necessary

31  adjustment or to purchase the necessary component within 90

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  1  days after of the date or receipt of the order. However, if

  2  the radiation machine cannot be made to meet the standards,

  3  the department shall order the owner to cease the use

  4  utilization of the radiation machine.

  5         Section 31.  Subsection (3) of section 489.553, Florida

  6  Statutes, is amended to read:

  7         489.553  Administration of part; registration

  8  qualifications; examination.--

  9         (3)  The department shall adopt reasonable rules,

10  including, but not limited to, rules that which establish

11  ethical standards of practice, requirements for registering as

12  a contractor, requirements for obtaining an initial or renewal

13  certificate of registration, disciplinary guidelines, and

14  requirements for the certification of partnerships and

15  corporations. The department and may amend or repeal the rules

16  same in accordance with the Administrative Procedure Act.

17         Section 32.  Subsection (1) of section 491.006, Florida

18  Statutes, is amended to read:

19         491.006  Licensure or certification by endorsement.--

20         (1)  The department shall license or grant a

21  certificate to a person in a profession regulated by this

22  chapter who, upon applying to the department and remitting the

23  appropriate fee, demonstrates to the board that he or she:

24         (a)  Has demonstrated, in a manner designated by rule

25  of the board, knowledge of the laws and rules governing the

26  practice of clinical social work, marriage and family therapy,

27  and mental health counseling.

28         (b)1.  Holds an active valid license to practice and

29  has actively practiced the profession for which licensure is

30  applied in another state for 3 of the last 5 years immediately

31  preceding licensure.

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  1         2.  Meets the education requirements of this chapter

  2  for the profession for which licensure is applied.

  3         3.  Has passed a substantially equivalent licensing

  4  examination in another state or has passed the licensure

  5  examination in this state in the profession for which the

  6  applicant seeks licensure.

  7         4.  Holds a license in good standing, is not under

  8  investigation for an act that which would constitute a

  9  violation of this chapter, and has not been found to have

10  committed any act that which would constitute a violation of

11  this chapter. The fees paid by any applicant for certification

12  as a master social worker under this section are

13  nonrefundable.

14         Section 33.  Subsections (1) and (5) of section

15  491.0145, Florida Statutes, are amended to read:

16         491.0145  Certified master social worker.--The

17  department may certify an applicant for a designation as a

18  certified master social worker upon the following conditions:

19         (1)  The applicant completes an application to be

20  provided by the department and pays a nonrefundable fee not to

21  exceed $250 to be established by rule of the department.  The

22  completed application must be received by the department at

23  least 60 days before the date of the examination in order for

24  the applicant to qualify to take the scheduled exam.

25         (5)  The applicant has passed an examination required

26  by the department for this purpose.  The nonrefundable fee for

27  such examination may shall not exceed $250 as set by

28  department rule.

29         Section 34.  Present subsections (11) through (29) of

30  section 499.003, Florida Statutes, are redesignated as

31

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  1  subsections (12) through (30), respectively, and a new

  2  subsection (11) is added to that section, to read:

  3         499.003  Definitions of terms used in ss.

  4  499.001-499.081.--As used in ss. 499.001-499.081, the term:

  5         (11)  "Distribute or distribution" means to sell; offer

  6  to sell; give away; transfer, whether by passage of title,

  7  physical movement, or both; deliver; or offer to deliver. The

  8  term does not mean to administer or dispense.

  9         Section 35.  Subsections (25) and (26) are added to

10  section 499.005, Florida Statutes, to read:

11         499.005  Prohibited acts.--It is unlawful to perform or

12  cause the performance of any of the following acts in this

13  state:

14         (25)  Charging a dispensing fee for dispensing,

15  administering, or distributing a prescription drug sample.

16         (26)  Dispensing, administering, or distributing an

17  investigational drug authorized under s. 499.018, except

18  pursuant to a protocol approved by the department.

19         Section 36.  Subsection (8) is added to section

20  499.0054, Florida Statutes, to read:

21         499.0054  Advertising and labeling of drugs, devices,

22  and cosmetics.--It is a violation of the Florida Drug and

23  Cosmetic Act to perform or cause the performance of any of the

24  following acts:

25         (8)  The representation or suggestion in labeling or

26  advertising that an article is approved under ss.

27  499.001-499.081, when such is not the case.

28         Section 37.  Subsection (2) and paragraph (d) of

29  subsection (4) of section 499.01, Florida Statutes, are

30  amended to read:

31

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  1         499.01  Permits; applications; renewal; general

  2  requirements.--

  3         (2)  The department shall establish, by rule, the form

  4  and content of the application to obtain or renew a permit.

  5  The applicant must submit to the department with the

  6  application a statement that swears or affirms that the

  7  information is true and correct.

  8         (a)  Information that an applicant must provide

  9  includes, but need not be limited to:

10         1.  The name, full business address, and telephone

11  number of the applicant;

12         2.  All trade or business names used by the applicant;

13         3.  The address, telephone numbers, and the names of

14  contact persons for each facility used by the applicant for

15  the storage, handling, and distribution of prescription drugs;

16         4.  The type of ownership or operation, such as a

17  partnership, corporation, or sole proprietorship; and

18         5.  The names of the owner and the operator of the

19  establishment, including:

20         a.  If an individual, the name of the individual;

21         b.  If a partnership, the name of each partner and the

22  name of the partnership;

23         c.  If a corporation, the name and title of each

24  corporate officer and director, the corporate names, and the

25  name of the state of incorporation;

26         d.  If a sole proprietorship, the full name of the sole

27  proprietor and the name of the business entity; and

28         e.  Any other relevant information that the department

29  requires.

30         (b)  Upon approval of the application by the department

31  and payment of the required fee, the department shall issue a

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  1  permit to the applicant, if the applicant meets the

  2  requirements of ss. 499.001-499.081 and rules adopted under

  3  those sections.

  4         (c)  Any change in information required under paragraph

  5  (a) must be submitted to the department before the change

  6  occurs.

  7         (d)  The department shall consider, at a minimum, the

  8  following factors in reviewing the qualifications of persons

  9  to be permitted under ss. 499.001-499.081:

10         1.  The applicant's having been found guilty,

11  regardless of adjudication, in a court of this state or other

12  jurisdiction, of a violation of a law that directly relates to

13  a drug, device, or cosmetic.  A plea of nolo contendere

14  constitutes a finding of guilt for purposes of this

15  subparagraph.

16         2.  The applicant's having been disciplined by a

17  regulatory agency in any state for any offense that would

18  constitute a violation of ss. 499.001-499.081.

19         3.  Any felony conviction of the applicant under a

20  federal, state, or local law;

21         4.  The applicant's past experience in manufacturing or

22  distributing drugs, devices, or cosmetics;

23         5.  The furnishing by the applicant of false or

24  fraudulent material in any application made in connection with

25  manufacturing or distributing drugs, devices, or cosmetics;

26         6.  Suspension or revocation by a federal, state, or

27  local government of any permit currently or previously held by

28  the applicant for the manufacture or distribution of any

29  drugs, devices, or cosmetics;

30         7.  Compliance with permitting requirements under any

31  previously granted permits;

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  1         8.  Compliance with requirements to maintain or make

  2  available to the state permitting authority or to federal,

  3  state, or local law enforcement officials those records

  4  required under this section; and

  5         9.  Any other factors or qualifications the department

  6  considers relevant to and consistent with the public health

  7  and safety.

  8         (4)  A permit issued by the department is

  9  nontransferable.  Each permit is valid only for the person or

10  governmental unit to which it is issued and is not subject to

11  sale, assignment, or other transfer, voluntarily or

12  involuntarily; nor is a permit valid for any establishment

13  other than the establishment for which it was originally

14  issued.

15         (d)  If an establishment permitted under ss.

16  499.001-499.081 closes, the owner must notify the department

17  in writing before the effective date of closure and must:

18         1.  Return the permit to the department;

19         2.  If the permittee is authorized to distribute legend

20  drugs, indicate the disposition of such drugs, including the

21  name, address, and inventory, and provide the name and address

22  of a person to contact regarding access to records that are

23  required to be maintained under ss. 499.001-499.081.  Transfer

24  of ownership of legend drugs may be made only to persons

25  authorized to possess legend drugs under ss. 499.001-499.081.

26         Section 38.  Paragraph (c) is added to subsection (2)

27  of section 499.0121, Florida Statutes, to read:

28         499.0121  Storage and handling of prescription

29  drugs.--The department shall adopt rules to implement this

30  section as necessary to protect the public health, safety, and

31  welfare.  Such rules shall include, but not be limited to,

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  1  requirements for the storage and handling of prescription

  2  drugs and for the establishment and maintenance of

  3  prescription drug distribution records.

  4         (2)  SECURITY.--

  5         (c)  Any vehicle that contains prescription drugs must

  6  be secure from unauthorized access to the prescription drugs

  7  in the vehicle.

  8         Section 39.  Paragraph (b) of subsection (2) of section

  9  499.0122, Florida Statutes, is amended to read:

10         499.0122  Medical oxygen and veterinary legend drug

11  retail establishments; definitions, permits, general

12  requirements.--

13         (2)

14         (b)  The department shall adopt rules relating to

15  information required from each retail establishment pursuant

16  to s. 499.01(2), including requirements for prescriptions or

17  orders.

18         Section 40.  Paragraph (d) of subsection (2) of section

19  499.013, Florida Statutes, is amended, and subsection (4) is

20  added to that section, to read:

21         499.013  Manufacturers of drugs, devices, and

22  cosmetics; definitions, permits, and general requirements.--

23         (2)  Any person that engages in the manufacture of

24  drugs, devices, or cosmetics in this state must first obtain

25  one of the following permits and may engage only in the

26  activity allowed under that permit:

27         (d)  A device manufacturer's permit is required for any

28  person that engages in the manufacture or assembly of medical

29  devices for human use in this state, except that a permit is

30  not required if the person is engaged only in manufacturing or

31

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  1  assembling a medical device pursuant to a practitioner's order

  2  for a specific patient.

  3         1.  A manufacturer of medical devices in this state

  4  must comply with all appropriate state and federal good

  5  manufacturing practices.

  6         2.  The department shall adopt rules related to

  7  storage, handling, and recordkeeping requirements for

  8  manufacturers of medical devices for human use.

  9         (4)  Each manufacturer of medical devices,

10  over-the-counter drugs, or cosmetics must maintain records

11  that include the name and principal address of the seller or

12  transferor of the product, the address of the location from

13  which the product was shipped, the date of the transaction,

14  the name and quantity of the product involved, and the name

15  and principal address of the person who purchased the product.

16         Section 41.  Subsections (1) and (3) of section

17  499.015, Florida Statutes, are amended to read:

18         499.015  Registration of drugs, devices, and cosmetics;

19  issuance of certificates of free sale.--

20         (1)(a)  Except for those persons exempted from the

21  definition in s. 499.003(22) s. 499.003(21), any person who

22  manufactures, packages, repackages, labels, or relabels a

23  drug, device, or cosmetic in this state must register such

24  drug, device, or cosmetic biennially with the department; pay

25  a fee in accordance with the fee schedule provided by s.

26  499.041; and comply with this section. The registrant must

27  list each separate and distinct drug, device, or cosmetic at

28  the time of registration.

29         (b)  The department may not register any product that

30  does not comply with the Federal Food, Drug, and Cosmetic Act,

31  as amended, or Title 21 C.F.R., or that is not an approved

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  1  investigational drug as provided for in s. 499.018.

  2  Registration of a product by the department does not mean that

  3  the product does in fact comply with all provisions of the

  4  Federal Food, Drug, and Cosmetic Act, as amended.

  5         (3)  Except for those persons exempted from the

  6  definition in s. 499.003(22) s. 499.003(21), a person may not

  7  sell any product that he or she has failed to register in

  8  conformity with this section. Such failure to register

  9  subjects such drug, device, or cosmetic product to seizure and

10  condemnation as provided in ss. 499.062-499.064, and subjects

11  such person to the penalties and remedies provided in ss.

12  499.001-499.081.

13         Section 42.  Subsection (4) of section 499.024, Florida

14  Statutes, is amended to read:

15         499.024  Drug product classification.--The secretary

16  shall adopt rules to classify drug products intended for use

17  by humans which the United States Food and Drug Administration

18  has not classified in the federal act or the Code of Federal

19  Regulations.

20         (4)  Any product that falls under the drug definition,

21  s. 499.003(12) s. 499.003(11), may be classified under the

22  authority of this section.  This section does not subject

23  portable emergency oxygen inhalators to classification;

24  however, this section does not exempt any person from ss.

25  499.01 and 499.015.

26         Section 43.  Subsection (1) of section 499.03, Florida

27  Statutes, is amended to read:

28         499.03  Possession of new drugs or legend drugs without

29  prescriptions unlawful; exemptions and exceptions.--

30         (1)  A person may not possess, or possess with intent

31  to sell, dispense, or deliver, any habit-forming, toxic,

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  1  harmful, or new drug subject to s. 499.003(23) s. 499.003(22),

  2  or legend drug as defined in s. 499.003, unless the possession

  3  of the drug has been obtained by a valid prescription of a

  4  practitioner licensed by law to prescribe the drug.  However,

  5  this section does not apply to the delivery of such drugs to

  6  persons included in any of the classes named in this

  7  subsection, or to the agents or employees of such persons, for

  8  use in the usual course of their businesses or practices or in

  9  the performance of their official duties, as the case may be;

10  nor does this section apply to the possession of such drugs by

11  those persons or their agents or employees for such use:

12         (a)  A licensed pharmacist or any person under the

13  licensed pharmacist's supervision while acting within the

14  scope of the licensed pharmacist's practice;

15         (b)  A licensed practitioner authorized by law to

16  prescribe legend drugs or any person under the licensed

17  practitioner's supervision while acting within the scope of

18  the licensed practitioner's practice;

19         (c)  A qualified person who uses legend drugs for

20  lawful research, teaching, or testing, and not for resale;

21         (d)  A licensed hospital or other institution that

22  procures such drugs for lawful administration or dispensing by

23  practitioners;

24         (e)  An officer or employee of a federal, state, or

25  local government; or

26         (f)  A person that holds a valid permit issued by the

27  department pursuant to ss. 499.001-499.081 which authorizes

28  that person to possess prescription drugs.

29         Section 44.  Subsection (1) of section 499.05, Florida

30  Statutes, is amended to read:

31         499.05  Rules.--

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  1         (1)  The department shall adopt rules to implement and

  2  enforce ss. 499.001-499.081 with respect to:.

  3         (a)  The definition of terms used in ss.

  4  499.001-499.081, and used in the rules adopted under ss.

  5  499.001-499.081, when the use of the term is not its usual and

  6  ordinary meaning.

  7         (b)  Labeling requirements for drugs, devices, and

  8  cosmetics.

  9         (c)  Application requirements, protocols, reporting

10  requirements, and requirements for submitting other

11  information to the department and the Florida Drug Technical

12  Review Panel, as required under the investigational drug

13  program.

14         (d)  The establishment of fees authorized in ss.

15  499.001-499.081.

16         (e)  The identification of permits that require an

17  initial application and onsite inspection or other

18  prerequisites for permitting which demonstrate that the

19  establishment and person are in compliance with the

20  requirements of ss. 499.001-499.081.

21         (f)  The application processes and forms for product

22  registration.

23         (g)  Procedures for requesting and issuing certificates

24  of free sale.

25         (h)  Inspections and investigations conducted under s.

26  499.051, and the identification of information claimed to be a

27  trade secret and exempt from the public records law as

28  provided in s. 499.051(5).

29         (i)  The establishment of a range of penalties, as

30  provided in s. 499.006; requirements for notifying persons of

31  the potential impact of a violation of ss. 499.001-499.081;

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  1  and a process for the uncontested settlement of alleged

  2  violations.

  3         (j)  Additional conditions that qualify as an emergency

  4  medical reason under s. 499.012(1)(a)2.b.

  5         Section 45.  Section 499.701, Florida Statutes, is

  6  amended to read:

  7         499.701  Adoption of rules by the department.--

  8         (1)  The department shall adopt and enforce rules

  9  necessary to the administration of its authority under this

10  part. The Said rules must shall be such as are reasonably

11  necessary for the protection of the health, welfare, and

12  safety of the public and persons manufacturing, distributing,

13  dealing, and possessing ether, and must provide for

14  application forms and procedures, recordkeeping requirements,

15  and security. The rules must and shall be in substantial

16  conformity with generally accepted standards of safety

17  concerning such subject matter.

18         (2)  The department may adopt rules regarding

19  recordkeeping and security for methyl ethyl ketone (MEK) or

20  butyl acetate as needed.  These products and records are open

21  to inspection in the same manner as are ether products and

22  records.

23         Section 46.  Paragraph (d) of subsection (2) of section

24  501.122, Florida Statutes, is amended to read:

25         501.122  Control of nonionizing radiations; laser;

26  penalties.--

27         (2)  AUTHORITY TO ISSUE REGULATIONS.--Except for

28  electrical transmission and distribution lines and substation

29  facilities subject to regulation by the Department of

30  Environmental Protection pursuant to chapter 403, the

31  Department of Health shall adopt rules as necessary to protect

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  1  the health and safety of persons exposed to laser devices and

  2  other nonionizing radiation, including the user or any others

  3  who might come in contact with such radiation. The Department

  4  of Health may:

  5         (d)  Establish and prescribe performance standards for

  6  lasers and other radiation control, including requirements for

  7  radiation surveys and measurements and the methods and

  8  instruments used to perform surveys; the qualifications,

  9  duties, and training of users; the posting of warning signs

10  and labels for facilities and devices; recordkeeping; and

11  reports to the department, if it determines that such

12  standards are necessary for the protection of the public

13  health.

14         Section 47.  Section 513.05, Florida Statutes, is

15  amended to read:

16         513.05  Rules.--The department may adopt rules

17  pertaining to the location, construction, modification,

18  equipment, and operation of mobile home parks, lodging parks,

19  recreational vehicle parks, and recreational camps, except as

20  provided in s. 633.022, as necessary to administer implement

21  this chapter. Such rules may include definitions of terms;

22  requirements for plan reviews of proposed and existing parks

23  and camps; plan reviews of parks that consolidate space or

24  change space size; water supply; sewage collection and

25  disposal; plumbing and backflow prevention; garbage and refuse

26  storage, collection, and disposal; insect and rodent control;

27  space requirements; heating facilities; food service;

28  lighting; sanitary facilities; bedding; an occupancy

29  equivalency to spaces for permits for recreational camps;

30  sanitary facilities in recreational vehicle parks; and the

31

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  1  owners' responsibilities at recreational vehicle parks and

  2  recreational camps.

  3         Section 48.  Section 514.021, Florida Statutes, is

  4  amended to read:

  5         514.021  Department authorization.--The department may

  6  is authorized to adopt and enforce rules, which may include

  7  definitions of terms, to protect the health, safety, or

  8  welfare of persons using public swimming pools and bathing

  9  places.  The department shall review and revise such rules as

10  necessary, but not less than biannually. Sanitation and safety

11  standards shall include, but not be limited to, matters

12  relating to structure; appurtenances; operation; source of

13  water supply; bacteriological, chemical, and physical quality

14  of water in the pool or bathing area; method of water

15  purification, treatment, and disinfection; lifesaving

16  apparatus; measures to ensure safety of bathers; and measures

17  to ensure the personal cleanliness of bathers.

18         Section 49.  Section 766.1115, Florida Statutes, is

19  amended to read:

20         766.1115  Health care providers; creation of agency

21  relationship with governmental contractors.--

22         (1)  SHORT TITLE.--This section may be cited as the

23  "Access to Health Care Act."

24         (2)  FINDINGS AND INTENT.--The Legislature finds that a

25  significant proportion of the residents of this state who are

26  uninsured or Medicaid recipients are unable to access needed

27  health care because health care providers fear the increased

28  risk of medical malpractice liability.  It is the intent of

29  the Legislature that access to medical care for indigent

30  residents be improved by providing governmental protection to

31  health care providers who offer free quality medical services

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  1  to underserved populations of the state.  Therefore, it is the

  2  intent of the Legislature to ensure that health care

  3  professionals who contract to provide such services as agents

  4  of the state are provided sovereign immunity.

  5         (3)  DEFINITIONS.--As used in this section, the term:

  6         (a)  "Contract" means an agreement executed in

  7  compliance with this section between a health care provider

  8  and a governmental contractor. This contract shall allow the

  9  health care provider to deliver health care services to

10  low-income recipients as an agent of the governmental

11  contractor. The contract must be for volunteer, uncompensated

12  services.

13         (b)  "Department" means the Department of Health.

14         (c)  "Governmental contractor" means the department,

15  county health departments, a special taxing district with

16  health care responsibilities, or a hospital owned and operated

17  by a governmental entity.

18         (d)  "Health care provider" or "provider" means:

19         1.  A birth center licensed under chapter 383.

20         2.  An ambulatory surgical center licensed under

21  chapter 395.

22         3.  A hospital licensed under chapter 395.

23         4.  A physician or physician assistant licensed under

24  chapter 458.

25         5.  An osteopathic physician or osteopathic physician

26  assistant licensed under chapter 459.

27         6.  A chiropractic physician licensed under chapter

28  460.

29         7.  A podiatric physician licensed under chapter 461.

30         8.  A registered nurse, nurse midwife, licensed

31  practical nurse, or advanced registered nurse practitioner

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  1  licensed or registered under chapter 464 or any facility which

  2  employs nurses licensed or registered under chapter 464 to

  3  supply all or part of the care delivered under this section.

  4         9.  A midwife licensed under chapter 467.

  5         10.  A health maintenance organization certificated

  6  under part I of chapter 641.

  7         11.  A health care professional association and its

  8  employees or a corporate medical group and its employees.

  9         12.  Any other medical facility the primary purpose of

10  which is to deliver human medical diagnostic services or which

11  delivers nonsurgical human medical treatment, and which

12  includes an office maintained by a provider.

13         13.  A dentist or dental hygienist licensed under

14  chapter 466.

15         14.  Any other health care professional, practitioner,

16  provider, or facility under contract with a governmental

17  contractor, including a student enrolled in an accredited

18  program that prepares the student for licensure as any one of

19  the professionals listed in subparagraphs 4. through 9.

20

21  The term includes any nonprofit corporation qualified as

22  exempt from federal income taxation under s. 501(c) of the

23  Internal Revenue Code which delivers health care services

24  provided by licensed professionals listed in this paragraph,

25  any federally funded community health center, and any

26  volunteer corporation or volunteer health care provider that

27  delivers health care services.

28         (e)  "Low-income" means:

29         1.  A person who is Medicaid-eligible under Florida

30  law;

31

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  1         2.  A person who is without health insurance and whose

  2  family income does not exceed 150 percent of the federal

  3  poverty level as defined annually by the federal Office of

  4  Management and Budget; or

  5         3.  Any client of the department who voluntarily

  6  chooses to participate in a program offered or approved by the

  7  department and meets the program eligibility guidelines of the

  8  department.

  9         (4)  CONTRACT REQUIREMENTS.--A health care provider

10  that executes a contract with a governmental contractor to

11  deliver health care services on or after April 17, 1992, as an

12  agent of the governmental contractor is an agent for purposes

13  of s. 768.28(9), while acting within the scope of duties

14  pursuant to the contract, if the contract complies with the

15  requirements of this section and regardless of whether the

16  individual treated is later found to be ineligible.  A health

17  care provider under contract with the state may not be named

18  as a defendant in any action arising out of the medical care

19  or treatment provided on or after April 17, 1992, pursuant to

20  contracts entered into under this section.  The contract must

21  provide that:

22         (a)  The right of dismissal or termination of any

23  health care provider delivering services pursuant to the

24  contract is retained by the governmental contractor.

25         (b)  The governmental contractor has access to the

26  patient records of any health care provider delivering

27  services pursuant to the contract.

28         (c)  Adverse incidents and information on treatment

29  outcomes must be reported by any health care provider to the

30  governmental contractor if such incidents and information

31  pertain to a patient treated pursuant to the contract. The

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  1  health care provider shall annually submit an adverse incident

  2  report that includes all information required by s.

  3  395.0197(6)(a), unless the adverse incident involves a result

  4  described by s. 395.0197(8), in which case it shall be

  5  reported within 15 days after the occurrence of such incident.

  6  If an incident involves a professional licensed by the

  7  Department of Health or a facility licensed by the Agency for

  8  Health Care Administration, the governmental contractor shall

  9  submit such incident reports to the appropriate department or

10  agency, which shall review each incident and determine whether

11  it involves conduct by the licensee that is subject to

12  disciplinary action. All patient medical records and any

13  identifying information contained in adverse incident reports

14  and treatment outcomes which are obtained by governmental

15  entities pursuant to this paragraph are confidential and

16  exempt from the provisions of s. 119.07(1) and s. 24(a), Art.

17  I of the State Constitution.

18         (d)  Patient selection and initial referral must be

19  made solely by the governmental contractor, and the provider

20  must accept all referred patients. However, the number of

21  patients that must be accepted may be limited by the contract,

22  and patients may not be transferred to the provider based on a

23  violation of the antidumping provisions of the Omnibus Budget

24  Reconciliation Act of 1989, the Omnibus Budget Reconciliation

25  Act of 1990, or chapter 395.

26         (e)  If emergency care is required, the patient need

27  not be referred before receiving treatment, but must be

28  referred within 48 hours after treatment is commenced or

29  within 48 hours after the patient has the mental capacity to

30  consent to treatment, whichever occurs later.

31

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  1         (f)  Patient care, including any followup or hospital

  2  care, is subject to approval by the governmental contractor.

  3         (g)  The provider is subject to supervision and regular

  4  inspection by the governmental contractor.

  5

  6  A governmental contractor that is also a health care provider

  7  is not required to enter into a contract under this section

  8  with respect to the health care services delivered by its

  9  employees.

10         (5)  NOTICE OF AGENCY RELATIONSHIP.--The governmental

11  contractor must provide written notice to each patient, or the

12  patient's legal representative, receipt of which must be

13  acknowledged in writing, that the provider is an agent of the

14  governmental contractor and that the exclusive remedy for

15  injury or damage suffered as the result of any act or omission

16  of the provider or of any employee or agent thereof acting

17  within the scope of duties pursuant to the contract is by

18  commencement of an action pursuant to the provisions of s.

19  768.28. With respect to any federally funded community health

20  center, the notice requirements may be met by posting in a

21  place conspicuous to all persons a notice that the federally

22  funded community health center is an agent of the governmental

23  contractor and that the exclusive remedy for injury or damage

24  suffered as the result of any act or omission of the provider

25  or of any employee or agent thereof acting within the scope of

26  duties pursuant to the contract is by commencement of an

27  action pursuant to the provisions of s. 768.28.

28         (6)  QUALITY ASSURANCE PROGRAM REQUIRED.--The

29  governmental contractor shall establish a quality assurance

30  program to monitor services delivered under any contract

31

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  1  between an agency and a health care provider pursuant to this

  2  section.

  3         (7)  RISK MANAGEMENT REPORT.--The Division of Risk

  4  Management of the Department of Insurance shall annually

  5  compile a report of all claims statistics for all entities

  6  participating in the risk management program administered by

  7  the division, which shall include the number and total of all

  8  claims pending and paid, and defense and handling costs

  9  associated with all claims brought against contract providers

10  under this section.  This report shall be forwarded to the

11  department and included in the annual report submitted to the

12  Legislature pursuant to this section.

13         (8)  REPORT TO THE LEGISLATURE.--Annually, the

14  department shall report to the President of the Senate, the

15  Speaker of the House of Representatives, and the minority

16  leaders and relevant substantive committee chairpersons of

17  both houses, summarizing the efficacy of access and treatment

18  outcomes with respect to providing health care services for

19  low-income persons pursuant to this section.

20         (9)  MALPRACTICE LITIGATION COSTS.--Governmental

21  contractors other than the department are responsible for

22  their own costs and attorney's fees for malpractice litigation

23  arising out of health care services delivered pursuant to this

24  section.

25         (10)  RULES.--The department shall adopt rules designed

26  to administer implement this section in a manner consistent

27  with its purpose to provide and facilitate access to

28  appropriate, safe, and cost-effective health care services and

29  to maintain health care quality. The rules may include

30  services to be provided and authorized procedures.

31

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CODING: Words stricken are deletions; words underlined are additions.






    Florida Senate - 2000                           CS for SB 2628
    317-2044-00




  1         (11)  APPLICABILITY.--This section applies to incidents

  2  occurring on or after April 17, 1992.  This section does not

  3  apply to any health care contract entered into by the

  4  Department of Corrections which is subject to s.

  5  768.28(10)(a). Nothing in this section in any way reduces or

  6  limits the rights of the state or any of its agencies or

  7  subdivisions to any benefit currently provided under s.

  8  768.28.

  9         Section 50.  This act shall take effect upon becoming a

10  law.

11

12          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
13                         Senate Bill 2628

14

15  The bill removes provisions granting rulemaking authority to
    the Department of Health for establishing requirements for
16  emergency medical services medical directors, including
    responsibilities, qualifications, and authorization to
17  determine medications, equipment, and staffing, requirements
    for developing protocols, and participation requirements for
18  quality assurance programs; and requirements relating to
    certificates of public convenience and necessity for emergency
19  medical services providers. The bill revises rulemaking
    authority extended to the department for determining whether a
20  convicted felon is eligible for certification or
    recertification as an emergency medical technician or
21  paramedic.

22

23

24

25

26

27

28

29

30

31

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