The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Health Policy
BILL: SB 1374
INTRODUCER: Senator Rodriguez
SUBJECT: Clinical Laboratory Testing
DATE: February 1, 2022
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Winkle
Brown
HP
Pre-meeting
2. AP
3. RC
I. Summary:
SB 1374 amends s. 483.801, F.S., to exempt persons performing alternate-site clinical laboratory
testing within a hospital or hospital-based off-campus emergency department licensed under ch.
395, F.S., from the application of the requirements of Part I of ch. 483, F.S.
The bill provides an effective date of July 1, 2022.
II. Present Situation:
The Department of Health
The Legislature created the DOH to protect and promote the health of all residents and visitors in
the state.
1
The DOH is charged with the regulation of health practitioners for the preservation of
the health, safety, and welfare of the public. The Division of Medical Quality Assurance (MQA)
is responsible for the boards
2
and professions within the DOH.
3
Clinical Laboratories
Part I of ch. 483, F.S., regulates clinical laboratories and laboratory personnel. The purpose of
this part is to protect the public health, safety, and welfare of the people of Florida from the
hazards of improper performance by clinical laboratory personnel.
1
Section 20.43, F.S.
2
Section 456.001(1), F.S., defines “board” as any board, commission, or other statutorily created entity, to the extent such
entity is authorized to exercise regulatory or rulemaking functions within the DOH or, in some cases, within the MQA.
3
Section 20.43, F.S.
REVISED: BILL: SB 1374 Page 2
In s. 483.800, F.S., the Legislature declares that clinical laboratories provide essential services to
practitioners of the healing arts
4
by furnishing vital information that is essential to a
determination of the nature, cause, and extent of the condition involved. Unreliable and
inaccurate reports may cause unnecessary anxiety, suffering, and financial burdens and may even
contribute directly to death. The protection of public and individual health requires the licensure
of clinical laboratory personnel who meet minimum requirements for safe practice. The
Legislature finds that laboratory testing technology continues to advance rapidly.
5
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.
6
Services performed in clinical
labs include:
7
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.
Federal Clinical Laboratory Regulations
Clinical laboratories that provide testing services in Florida must be certified by the federal
Clinical Laboratory Improvement Amendments of 1988 (CLIA) program.
8
The CLIA program
sets forth the conditions that all laboratories must meet to be certified to perform testing on
human specimens and applies to all laboratories seeking payment under the Medicare and
Medicaid programs.
9
The CLIA program categorizes laboratory tests by complexity (waived
tests, tests of moderate complexity, and tests of high complexity) and must be either CLIA-
exempt or possess a CLIA program certificate for each category of tests the clinical laboratory
will perform.
10
Under the CLIA program, a clinical laboratory performing waived tests, tests of moderate
complexity, or test of high complexity, or any combination of the three, must file a separate
applications for each laboratory location, unless it fits one of the following exceptions:
Laboratories that are not at a fixed location, that is, laboratories that move from testing site to
testing site, such as mobile units providing laboratory testing, health screening fairs, or other
temporary testing locations, may be covered under the certificate of the designated primary
site or home base, using its address;
Not-for-profit or federal, state, or local government laboratories that engage in limited public
health testing
11
may file a single application; and
4
Section 483.803(7), F.S., defines “licensed practitioners of the healing arts” as licensed allopathic physicians, osteopathic
physicians, chiropractic physicians, podiatric physicians, naturopaths, and dentists.
5
Section 483.800, F.S.
6
Section 483.803(2), F.S.
7
Section 483.803(a) - (c), F.S.
8
Section 395.009(1), F.S.
9
42 C.F.R. s. 493.1.
10
42 C.F.R. s. 493.5.
11
“Limited” means not more than a combination of 15 moderately complex or waived tests per certificate. BILL: SB 1374 Page 3
Laboratories within a hospital that are located at contiguous buildings on the same campus
and under common direction may file a single application or multiple applications for the
laboratory sites within the same physical location or street address.
12
A CLIA program certified clinical laboratory must also meet the federal requirements related to
laboratory testing personnel in 42 C.F.R. ss. 493.1406 through 493.1491.
The CLIA program requires that each individual performing high complexity testing must
possess a state-issued license if licensure is required in the state in which the laboratory is
located, and meet one of the following requirements:
13
Be a licensed allopathic or osteopathic physician (MD or DO), or doctor of podiatric
medicine (DPM); or
Have earned a doctorate, master’s, or bachelor’s in laboratory science; or
Have earned an associate degree in laboratory science with the following; or
o 60 semester hours including 24 semester hours of medical lab technology; or,
o 60 semester hours including 24 hours of science that includes six hours of chemistry, six
hours of biology, and 12 hours of chemistry, biology or, medical lab technology in any
combination and laboratory training that includes either:
Completion of a clinical lab training program; or
Three months of training in each specialty the high complexity testing is performed;
or
Previously qualified or could have qualified as a technologist under federal regulations prior
to February 28, 1992.
The CLIA program requires that each individual performing moderate complexity testing must
possess a state-issued license if licensure is required in the state in which the laboratory is
located, and meet one of the following requirements:
14
Be qualified to perform high complexity testing; or
Be a licensed MD, DO, or DPM; or
Have earned a doctorate, master’s, bachelor’s, or associate’s degree in laboratory science; or
Be a high school graduate or equivalent, and
o Have had 50 weeks military training as medical lab specialist; or
o Have documentation of training appropriate to testing to be performed. Training must
ensure skills in:
Specimen collection, labeling, preparation, etc.;
Implementing laboratory procedures;
Performing assigned tests;
Conducting preventative maintenance, troubleshooting, calibration;
Knowledge of reagent stability and storage;
Implementing quality control (QC) procedures;
Knowledge of factors influencing test results; and
Validating patient test results with QC before reporting.
12
42 C.F.R. ss. 493.35, 493.43 and 493.55.
13
42 C.F.R. s. 493.1489.
14
42 C.F.R. s. 493.1423. BILL: SB 1374 Page 4
There are no specific CLIA program requirements for clinical laboratory personnel performing
waived testing only.
Clinical Lab Personnel
In addition to the federal CLIA program clinical laboratory personnel requirements set out in 42
C.F.R. 493.1406 through 493.1491, clinical laboratories in Florida must also meet the clinical
laboratory personnel requirements in part I, ch. 483, F.S.
“Clinical laboratory personnel” in Florida includes a clinical laboratory director, supervisor,
technologist, blood gas analyst, or technician who performs or is responsible for laboratory test
procedures, but the term does not include trainees, persons who perform screening for blood
banks or plasmapheresis centers, phlebotomists, or persons employed by a clinical laboratory to
perform manual pretesting duties or clerical, personnel, or other administrative responsibilities.
15
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.
16
Part I of ch. 483, F.S., applies to all clinical laboratories and clinical laboratory personnel within
this state, except:
17
Clinical laboratories operated by the U.S. government;
Laboratories operated exclusively for research and teaching purposes, involving no patient or
public health services;
Persons engaged in testing in 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 perform no testing on patients for non-member group member healthcare
providers;
Respiratory therapists and respiratory care practitioners certified or registered under Part V of
ch. 468. F.S.;
Advanced practice registered nurses licensed under Part I of ch. 464, F.S., who are engaged
in performing provider-performed microscopy procedures in laboratories that are wholly
owned and operated by one or more licensed allopathic physicians, osteopathic physicians,
chiropractic physicians, podiatric physicians, naturopaths, optometrists and dentists who
practice in the same group practice; and
Persons performing laboratory testing within a physician’s office 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 under ch. 395, F.S.
15
Section 483.803(4), F.S.
16
Section 483.809, F.S. and Fla. Admin. Code R. 64B3-5, (2021).
17
Section 483.801, F.S. BILL: SB 1374 Page 5
Alternate-site Lab Testing
The term “alternate-site testing” includes any laboratory testing done under the administrative
control of a hospital but performed out of the physical or administrative confines of the central
laboratory.
18
Alternate-site testing locations are hospital units or departments on the hospital
premises that are located outside of the physical or administrative confines of the hospital’s
central laboratory, but are still under the administrative control of the hospital and under the
supervision of the laboratory director.
19
A hospital laboratory may operate more than one alternate-site. A Florida hospital is required to
provide on the premises, or by contract, clinical and pathology laboratory services commensurate
with the hospital’s needs. The hospital laboratory, and any contracted laboratory providing
services for hospital patients, must be certified by the federal Centers for Medicare & Medicaid
Services (CMS) under the federal CLIA program and the federal rules adopted thereunder in all
specialties or subspecialties in which testing is performed. Hospitals may operate more than one
CLIA program certified laboratory on site or at satellite locations that are certified by the CLIA
program and on the same or adjoining grounds of a hospital licensed under ch. 395, F.S.
20
Section 395.0091, F.S., requires the Agency for Health Care Administration (AHCA), in
consultation with the Board, to adopt by rule criteria for alternate-site testing to be performed
under the supervision of a clinical laboratory director.
21
At a minimum, the criteria must include
the following:
The hospital’s internal needs assessment;
A protocol for implementation, including the identification of tests to be performed and who
will perform them;
Selection of the method of testing to be used for alternate-site testing;
Minimum training and education requirements for those who will perform alternate-site
testing, such as documented training, licensure, certification, or other medical professional
background not limited to laboratory professionals;
Documented in-service training and initial and ongoing competency validation;
An appropriate internal and external quality control protocol;
An internal mechanism for the central laboratory to identify and track alternate-site testing;
and
Recordkeeping requirements.
Alternate-site testing locations must be registered when the hospital applies to renew its
license.
22
Current AHCA rule does not require authorized alternate-site testing personnel to be licensed
under Part I of ch. 483, F.S., as laboratory personnel but does require personnel to have a high
18
Section 395.0091, F.S.
19
Fla. Admin. Code R. 59A-3.242 (1)(g), (2021).
20
Section 395.002(13)(b), F.S. and Fla. Admin. Code R. 59A-3.242 (1), (2021).
21
Fla. Admin. Code R. 59A-3.242 (1), (2021).
22
Section 395.0091, F.S. BILL: SB 1374 Page 6
school diploma or its equivalent, satisfy the HIV/AIDS educational requirements of s. 381.0035,
F.S., and be licensed or certified as one of the following:
23
Emergency medical technician;
Paramedic;
Physician assistant;
Anesthesiologist assistant;
Advanced practice registered nurse;
Registered nurse;
Licensed practical nurse;
Radiologic technologist;
Respiratory care practitioner in critical care services;
Respiratory therapist;
Clinical laboratory director, supervisor, technologist, technician, or person exempt from such
licensure;
Phlebotomist;
Clinical laboratory assistant;
Medical laboratory assistant;
Perfusionist with specific experience; or
Cardiovascular technician.
The laboratory director will determine if the personnel listed above are suitable to perform
testing at an alternate-site.
24
Hospital-Based Off-Campus Emergency Departments
Section 395.002(10), F.S., defines a hospital-based off-campus emergency department (HB-
OCED) to mean a facility that:
Provides emergency services and care;
Is owned and operated by a licensed hospital and operates under the license of the hospital;
and
Is located on separate premises from the hospital.
Florida Administrative Code Rule 59A-3.066(2)(e), relating to hospital licensure procedures,
also refers to, “off-site emergency departments” in regard to hospital licensure applications for
additional off-site emergency departments. The American College of Emergency Physicians
defines a hospital-based, freestanding emergency department (HB-FED) as a licensed facility
that is structurally separate and distinct from a hospital and provides emergency care, and is also
referred to as an off-site, hospital-based or satellite emergency department.
25
CMS refers to these
23
Fla. Admin. Code R. 59A-3.242(1)(g)(6)d., (2021).
24
Fla. Admin. Code R. 59A-3.242(1)(g)(6)e., (2021).
25
American College of Emergency Physicians, Policy Statement, Freestanding Emergency Departments, June, 2014, Rev.
Apr., 2020, available at https://www.acep.org/patient-care/policy-statements/freestanding-emergency-departments/ (last
visited Jan. 26, 2022). BILL: SB 1374 Page 7
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.
26
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.
27
A single license
will be issued to a licensee for facilities located on separate premises, upon request of the
applicant. The license will specifically state the location of the facility, its services, and the
licensed beds available on each separate premises.
28
Additional statutory requirements for HB-
OCEDs may be found in s. 395.1041(3)(m), F.S., but none relate to clinical laboratory services.
The AHCA interprets existing law to allow a licensed hospital to establish and operate a HB-
OCED as part of the facility operations, similar to other hospital outpatient departments, without
a separate license. A hospital that wishes to establish a HD-OCED is required to get approval
from the AHCA’s Office of Plans and Construction.
29
Under current federal CLIA program regulations, a HB-OCED would be unable to operate an
onsite clinical laboratory or perform clinical laboratory tests, though the use of the mobile
laboratory testing service exemption would allow it to make clinical laboratory services available
to patients.
III. Effect of Proposed Changes:
SB 1374 amends s. 483.801, F.S., to exempt persons performing alternate-site clinical laboratory
testing within a hospital or HB-OCED licensed under ch. 395, F.S., from the application of the
requirements of Part I of ch. 483, F.S.
The bill provides an effective date of July 1, 2022.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
26
42 C.F.R. ss. 413.65(a)(2) and (d)(1) (2017). See also U.S. Department of Health & Human Services, Centers for Medicaid
& Medicare Services, Requirements for Provider-based Off-campus Emergency Departments (Jan. 11, 2008), available at
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter08-
08.pdf (last visited Jan. 26, 2022).
27
Section 395.002(23), F.S., defines “premises” as 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. For any licensee that is a teaching hospital as defined in s. 408.07, F.S., reasonable proximity includes any
buildings, beds, services, programs, and equipment under the dominion and control of the licensee that are located at a site
with a main address that is within one mile of the main address of the licensed facility; and all such buildings, beds, and
equipment may, at the request of a licensee or applicant, be included on the facility license as a single premises.
28
Fla. Admin. Code R. 59A-3.066(2)(i), (2021).
29
Fla. Admin. Code R. 59A-3.066(2)(e), (2021). See also Fla. Admin. Code R. 59A-3.080, (2021). BILL: SB 1374 Page 8
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None.
C. Government Sector Impact:
None.
VI. Technical Deficiencies:
None.
VII. Related Issues:
The bill might conflict with the federal CLIA program requirements in 42 C.F.R., part 493. The
federal CLIA program clinical laboratory location and personnel regulations still apply, even
with a state exemption.
VIII. Statutes Affected:
This bill substantially amends section 483.801 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None. BILL: SB 1374 Page 9
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.