This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h0931.PPH
DATE: 1/24/2022
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 931 Alternate-site Testing
SPONSOR(S): McClure
TIED BILLS: IDEN./SIM. BILLS: SB 1374
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Professions & Public Health Subcommittee Morris McElroy
2) Health Care Appropriations Subcommittee
3) Health & Human Services Committee
SUMMARY ANALYSIS
A clinical laboratory is the physical location in which services are performed to provide information or materials
for use in the diagnosis, prevention, or treatment of a disease or the identification or assessment of a medical
or physical condition. The Board of Clinical Laboratory Personnel within the Department of Health (DOH)
oversees the licensure and regulation of clinical laboratory personnel, including supervisors, technologists,
technicians, directors, and public health laboratory personnel. Licensure requirements for clinical laboratory
personnel include passage of an exam designated by the Board, completion of a medical technology training
program, and completion of applicable education requirements. With limited exceptions, including certain
laboratories and health care practitioners, only licensed clinical laboratory personnel may perform clinical
laboratory testing.
Generally, a hospital’s main or central laboratory, or satellite laboratories that are certified by federal law
established on the same or adjoining grounds of a licensed hospital, may perform clinical laboratory testing.
Current law allows for alternate-site testing, which is any laboratory testing done under the administrative
control of a hospital and the supervision of the laboratory director, but performed out of the physical or
administrative confines of the hospital’s central laboratory. This allows tests to be performed bedside, at a
nurse station, in an operating room or the emergency room, or anywhere else under the administrative control
of a hospital. Current Agency for Health Care Administration rule authorizes advanced practice registered
nurses, registered nurses, licensed practical nurses, and licensed clinical laboratory personnel to perform
testing at alternate-sites.
A freestanding emergency department (FED) is a facility that receives individuals for emergency care and is
structurally separate from a hospital. Only licensed clinical laboratory personnel may perform clinical laboratory
testing in a FED.
HB 931 exempts individuals who perform alternate-site testing outside of a central laboratory of a hospital or at
a hospital-based, off campus emergency department from clinical laboratory personnel licensure requirements.
This allows all individuals, not just licensed clinical laboratory personnel, to perform alternate-site testing within
a hospital or in a FED.
The bill has an insignificant, indeterminate fiscal impact on DOH and no fiscal impact on local governments.
The bill provides an effective date of July 1, 2022. STORAGE NAME: h0931.PPH PAGE: 2
DATE: 1/24/2022
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Clinical Laboratories
A clinical laboratory is the physical location in which services are performed to provide information or
materials for use in the diagnosis, prevention, or treatment of a disease or the identification or
assessment of a medical or physical condition.
1
Services performed in clinical labs include:
2
The examination of fluids or other materials taken from the human body;
The examination of tissue taken from the human body; and
The examination of cells from individual tissues or fluid taken from the human body.
Clinical laboratories that provide testing services in this state must be certified by the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) program under federal law.
3
Clinical Laboratory Personnel
The Board of Clinical Laboratory Personnel (Board) oversees the licensure and regulation of clinical
laboratory personnel, including supervisors, technologists, technicians, directors, and public health
laboratory personnel. Generally, licensure requirements for clinical laboratory personnel include
passage of an exam designated by the Board, completion of a medical technology training program,
and completion of applicable education requirements.
4
Current law provides exemptions from the application of part I of ch. 483, F.S., which regulates clinical
laboratory personnel. Exemptions include:
5
Clinical laboratories operated by the United States Government;
Laboratories operated and maintained exclusively for research and teaching purposes, involving
no patient or public health service whatsoever;
Persons engaged in testing performed by laboratories that are wholly owned and operated by
one or more licensed allopathic physicians, osteopathic physicians, chiropractic physicians,
podiatric physicians, naturopaths, optometrists, or dentists, who practice in the same group
practice, and in which no clinical laboratory work is performed for patients referred by any health
care provider who is not a member of that group practice;
Respiratory therapists and respiratory care practitioners certified or registered under part V of
chapter 468;
Advanced practice registered nurses licensed under part I of chapter 464 who perform provider-
performed microscopy procedures in a laboratory setting; and
Persons performing laboratory testing within a physician office practice for patients referred by a
health care provider who is a member of the same physician office practice, if the laboratory or
entity operating the laboratory within a physician office practice is under common ownership,
directly or indirectly, with an entity licensed pursuant to chapter 395.
Currently, nurses licensed under ch. 464, F.S., and laboratory technicians licensed under part I of ch.
483, F.S., are not exempt from clinical laboratory personnel regulation.
1
S. 483.803, F.S.
2
Ss. 483.803(2)(a)-(c), F.S.
3
S. 395.009(1), F.S.
4
Section 483.809, F.S. and ch. 64B3-5, F.A.C.
5
S. 483.801, F.S. STORAGE NAME: h0931.PPH PAGE: 3
DATE: 1/24/2022
Alternate-Site Laboratory Testing
Generally, a hospital’s main or central laboratory or satellite laboratories that are certified by CLIA
established on the same or adjoining grounds of a hospital licensed under ch. 395, F.S., may perform
clinical laboratory testing.
6
Testing at satellite labs must be done by licensed clinical laboratory
personnel. Section 395.0091, F.S., allows for alternate-site testing, which is any laboratory testing done
under the administrative control of a hospital and the supervision of the laboratory director, but
performed outside of the physical or administrative confines of the hospital’s central laboratory. This
allows tests to be performed bedside, at a nurse station, in an operating room or the emergency room,
or anywhere else under the administrative control of a hospital.
Current Agency for Health Care Administration rule authorizes advanced practice registered nurses,
registered nurses, licensed practical nurses, and licensed clinical laboratory personnel to perform
testing at alternate-sites.
7
However, current law does not authorize registered nurses or laboratory
technicians to perform alternate-site testing within a freestanding emergency department.
Freestanding Emergency Departments
A freestanding emergency department (FED) is a facility that receives individuals for emergency care
and is structurally separate from a hospital.
8
The federal Centers for Medicare and Medicaid Services
(CMS) refers to these facilities as Provider-based Off-campus Emergency Departments and requires
them to operate under the license of the main provider, for purposes of Medicare reimbursement.
9
In Florida, any licensed hospital which has a dedicated emergency department may provide emergency
services in a location separate from the hospital’s main premises.
10
There are no additional rules or
standards specific for FEDs; in fact, the term FED is not currently defined in statute or rule. The Agency
for Health Care Administration (AHCA) interprets existing law to allow a licensed hospital to establish
and operate a FED as part of facility operations, similar to other hospital outpatient departments,
without a separate license. However, a hospital that wishes to establish a FED is required to get
approval from AHCA’s Office of Plans and Construction.
11
Since 2016, the number of FEDs in Florida increased 45 percent, while the number of visits to FEDs
increased by 83 percent.
12
Currently, 96 FEDs operate under the licenses of 61 hospitals.
13
6
Rule 59A-3.242, F.A.C.
7
Rule 59A-3.242(1)(g)(6), F.A.C.
8
There is no single definition of FED, and there are different requirements as well as different names for FEDs depending on which state
they are located in.
9
42 C.F.R. § 413.65(a)(2) and (d)(1) (2017). See also CMS, Requirements for Provider-based Off-campus Emergency Departments (Jan.
11, 2008), available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-
Memos-to-States-and-Regions-Items/CMS1207239 (last visited Jan. 21, 2022).
10
S. 395.002(22), F.S. Premises means those buildings, beds, and equipment located at the address of the licensed facility and all other
buildings, beds, and equipment for the provision of hospital or ambulatory surgical care located in such reasonable proximity to the
address of the licensed facility as to appear to the public to be under the dominion and control of the licensee.
11
Rule 59A-3.066(2)(e), F.A.C.
12
Florida Agency for Health Care Administration, FloridaHealthFinder.gov, Data Summaries and Reports, Emergency Department Visits
and Admissions by Facility 2016-219, available at https://www.floridahealthfinder.gov/researchers/QuickStat/quickstat.aspx (last visited
Jan. 21, 2022).
13
Florida Agency for Health Care Administration, Hospital and Outpatient Services Unit, List of Florida Licensed Hospitals with Off-site
Emergency Departments as of Jan. 3, 2022, available at
https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/Reports.shtml (last visited Jan. 21, 2022). STORAGE NAME: h0931.PPH PAGE: 4
DATE: 1/24/2022
Effect of the Bill
Clinical Laboratory Personnel
The bill exempts individuals who perform alternate-site testing outside of a central laboratory of a
hospital or at a hospital-based, off campus emergency department from clinical laboratory personnel
regulation under part I of ch. 483, F.S. This allows all individuals, not just licensed clinical laboratory
personnel, to perform alternate-site testing within a hospital or in a FED.
The bill provides an effective date of July 1, 2022.
B. SECTION DIRECTORY:
Section 1: Amends s. 483.801, F.S., relating to exemptions.
Section 2: Provides an effective date of July 1, 2022.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
None.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.
STORAGE NAME: h0931.PPH PAGE: 5
DATE: 1/24/2022
D. FISCAL COMMENTS:
None.
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
Not applicable. The bill does not appear to affect county or municipal governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
Current law provides sufficient rulemaking authority to implement the provisions of the bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES