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 Appropriations
BILL: CS/CS/SB 1374
INTRODUCER: Appropriations Committee; Health Policy Committee; and Senator Rodriguez
SUBJECT: Clinical Laboratory Testing
DATE: February 23, 2022
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Winkle
Brown
HP
Fav/CS
2. Howard Sadberry AP Fav/CS
3. RC
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/CS/SB 1374 amends section 483.801, Florida Statutes, to exempt registered nurses (RNs)
licensed under chapter 464, Florida Statutes, who are determined by the clinical lab director of a
hospital or hospital-based off-campus emergency department licensed under chapter 395, Florida
Statutes, to be qualified under 42 Code of Federal Regulations (C.F.R.) section 493.1423 to
perform only moderate-level or waiver-level clinical laboratory testing in accordance with
section 395.0091 Florida Statutes, within the hospital or hospital-based off-campus emergency
department with a separate federal Clinical Laboratory Improvement Amendments (CLIA)
program clinical laboratory certification under 42 C.F.R. part 493.
The bill will have no fiscal impact on state government.
The bill provides an effective date of July 1, 2022.
II. Present Situation:
The Department of Health
The Legislature created the Department of Health (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
1
Section 20.43, F.S.
REVISED: BILL: CS/CS/SB 1374 Page 2
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.
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
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.
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. BILL: CS/CS/SB 1374 Page 3
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
application 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
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 a medical lab specialist; or
11
“Limited” means not more than a combination of 15 moderately complex or waived tests per certificate.
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: CS/CS/SB 1374 Page 4
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.
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;
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: CS/CS/SB 1374 Page 5
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.
Nurse Practice Act
Florida’s Nurse Practice Act is found in Part I of ch. 464, F.S. The purpose of the Nurse Practice
Act is to ensure that every nurse practicing in this state meets minimum requirements for safe
practice. It is legislative intent that nurses who fall below minimum competency or who
otherwise present a danger to the public are prohibited from practicing in this state.
18
Registered Nurse Licensure by Examination
Any person desiring to be licensed as a RN in Florida must apply to the DOH to take the
licensure examination. The DOH must examine each applicant who:
19
Has completed an application and remitted the appropriate fee;
Has submitted to a statewide criminal background check through the Florida Department of
Law Enforcement (FDLE);
Is in good mental and physical health;
Has received a high school diploma or the equivalent, and has completed the requirements
for:
o Graduation from a DOH approved nursing program;
o Graduation from a pre-licensure nursing education program that the Board of Nursing
(BON) determines is equivalent to a BON approved program;
o Graduation on or after July 1, 2009, from an accredited program; or
o Graduation before July 1, 2009, from a pre-licensure nursing education program whose
graduates at that time were eligible for examination; and
Has the ability to communicate in English, which may be determined by an examination
given by the DOH
Approved Registered Nursing Education Programs
All nursing programs requesting BON approval must conform to the Florida Department of
Education curriculum framework. In order to ensure the preparation of nurses capable of
competent practice, the curriculum must:
Reflect the stated philosophy and objectives of the program;
18
Section 464.002, F.S.
19
Section 464.008, F.S. BILL: CS/CS/SB 1374 Page 6
Evidence an organized pattern of instruction consistent with principles of learning and sound
educational practices;
Provide for systematic evaluation of student learning in both clinical experience and
theoretical instruction; and
Evidence ongoing program evaluation in relation to currency of content, competency of
instruction, adequacy of clinical experiences and effectiveness of graduate performance.
Each nursing program, and each campus offering nursing education, requires separate individual
approval from the BON. Programs may be offered in the following categories:
Professional nursing education programs that terminate in a bachelor’s degree;
Professional nursing education programs that terminate in an associate’s degree; and
Professional nursing education programs that terminate in a diploma.
20
The BON requires specific minimum requirements for professional nursing education programs.
Course content must include:
Medical;
Surgical;
Obstetrics;
Pediatrics;
Psychiatric;
Geriatric;
Acute care, long term care and community settings;
Personal, family, and community health concepts;
Nutrition;
Human growth and development throughout the life span;
Body structure and function;
Interpersonal relationship and leadership skills;
Mental health concepts;
Pharmacology and administration of medication;
Legal aspects of practice;
Professional role and function; and
Health teaching and counseling skills.
21
The percentage of clinical training required for curriculums for professional nursing programs
that terminate in a bachelor’s degree must consist of at least 40 percent clinical training. The
curriculums for professional nursing programs that terminate in an associate’s degree or a
diploma degree must consist of at least 50 percent clinical training.
22
Registered Nurses
A registered nurse is any person licensed in this state or holding an active multistate license
under the Nurse Practice Act to practice professional nursing. The practice of professional
nursing means performing acts requiring substantial specialized knowledge, judgment, and
20
Fla. Admin. Code R. 64B9-2.021 (2021).
21
Id.
22
Supra note 20. BILL: CS/CS/SB 1374 Page 7
nursing skill based on applied principles of psychological, biological, physical, and social
sciences and includes, but is not limited to:
The observation, assessment, nursing diagnosis, planning, intervention, and evaluation of
care; health teaching and counseling of the ill, injured, or infirm; and the promotion of
wellness, maintenance of health, and prevention of illness of others;
The administration of medications and treatments as prescribed or authorized by a duly
licensed practitioner authorized by the laws of this state to prescribe such medications and
treatments; and
The supervision and teaching of other personnel in the theory and performance of any of the
acts described in this subsection.
23
A professional nurse is responsible and accountable for making decisions that are based upon the
individual’s educational preparation and experience in nursing.
24
Currently, a professional registered nurse does not receive classroom education or clinical
training sufficient to satisfy the CLIA program requirements to act as clinical laboratory
personnel capable of performing all Moderate Complexity Laboratory Testing or All High
Complexity Laboratory testing without additional training.
25
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.
26
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.
27
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.
28
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
23
Section 464.003, F.S.
24
Id.
25
See 42 C.F.R. ss. 493. 1423 and 493.1489.
26
Section 395.0091, F.S.
27
Fla. Admin. Code R. 59A-3.242 (1)(g), (2021).
28
Section 395.002(13)(b), F.S. and Fla. Admin. Code R. 59A-3.242 (1), (2021). BILL: CS/CS/SB 1374 Page 8
under the supervision of a clinical laboratory director.
29
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.
30
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
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:
31
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.
29
Fla. Admin. Code R. 59A-3.242 (1), (2021).
30
Section 395.0091, F.S.
31
Fla. Admin. Code R. 59A-3.242(1)(g)(6)d., (2021). BILL: CS/CS/SB 1374 Page 9
The laboratory director will determine if the personnel listed above are suitable to perform
testing at an alternate-site.
32
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.
33
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.
34
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.
35
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.
36
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 HB-OCED is required to get approval
from the AHCA’s Office of Plans and Construction.
37
32
Fla. Admin. Code R. 59A-3.242(1)(g)(6)e., (2021).
33
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).
34
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).
35
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.
36
Fla. Admin. Code R. 59A-3.066(2)(i), (2021).
37
Fla. Admin. Code R. 59A-3.066(2)(e), (2021). See also Fla. Admin. Code R. 59A-3.080, (2021). BILL: CS/CS/SB 1374 Page 10
Under current federal CLIA program regulations, a HB-OCED without its own CLIA program
certificate 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:
The bill amends s. 483.801, F.S., to exempt RNs licensed under ch. 464, F.S., who are
determined by the clinical lab director of a hospital or HB-OCED licensed under ch. 395, F.S., to
be qualified under 42 C.F.R. s. 493.1423 to perform only moderate-level or waiver-level clinical
laboratory testing in accordance with s. 395.0091 F.S., within the hospital or hospital-based off-
campus emergency department with a separate federal CLIA program clinical laboratory
certification under 42 C.F.R. part 493.
The bill provides an effective date of July 1, 2022.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
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. BILL: CS/CS/SB 1374 Page 11
C. Government Sector Impact:
None.
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill substantially amends section 483.801 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS/CS by Appropriations on February 21, 2022:
The committee substitute puts the bill in compliance with all federal regulations for off
campus emergency department clinical laboratory testing.
CS by Health Policy on February 2, 2022:
The CS amends s. 483.801, F.S., to limit the unspecified “persons” exempted from the
application of Part I, ch. 483, F.S., to only exempting registered nurses 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.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.