clia & florida clinical laboratory requirements
TRANSCRIPT
Updated 1/10/11 1
Patty Lewandowski, MBA, MT (ASCP),
Program Administrator, Clinical Laboratory Unit
State of Florida, Agency for Health Care Administration
Division of Health Quality Assurance
AHCA Laboratory Unit: (850) 412-4500
CLIA & Florida Clinical
Laboratory Requirements
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Topics for Discussion
• Types of CLIA certificates and Florida Clinical
Laboratory licenses
• Application process for CLIA certification and
Florida Clinical Lab Licensure
• General requirements for clinical laboratories
• CLIA requirements
• State of Florida requirements
• Overview of 483.245 F.S. and 59A-7.020(14) and
59A-7.037 F.A.C. regarding Rebates prohibited
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CLIA History
CLIA (Clinical Laboratory Improvement
Amendments)
Passed by Congress in 1988 following false
negative Pap smear readings
Objective is to ensure quality laboratory testing
About 200,000 CLIA labs in the U.S.;
15,000 in Florida
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Do I need both a CLIA Certificate
and Florida Clinical Laboratory
License?
• Need both, a CLIA certificate and Florida license
for non-waived testing if you meet the definition of
a lab
• Need only federal CLIA Certificate of Waiver for
waived lab testing. Only certain tests and test kits
are classified as “waived” by the federal government.
• CLIA internet site listing waived tests:
• http://www.cms.gov/CLIA/10_Categorization_
of_Tests.asp
Definition of a Lab
• A lab is any facility performing testing on
human specimens for diagnosis, prevention,
treatment of disease, or assessment of health.
• Not needed if no laboratory tests are done in
your office and all specimens are sent out for
testing.
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How are Medicare & Medicaid
reimbursement for lab tests related to
CLIA?
Clinical laboratories must be properly
certified to receive Medicare or Medicaid
payments.
The CLIA program does not have direct
responsibilities for Medicare or Medicaid.
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AHCA
The Agency for Health Care Administration
(AHCA) handles both the CLIA certification
program for Florida and the Florida licensure
for clinical Laboratories. AHCA does not
handle billing.
Internet site for AHCA:
http://ahca.myflorida.com
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http://ahca.myflorida.com/labs
Detailed information and links to state and
CLIA application forms are available on the
Internet site.
Both state and CLIA applications are required
for new nonwaived labs.
Only a CLIA application is required for a waived
lab
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Lab Application Process
Initial application forms for both CLIA and state should be sent to AHCA.
Background screening is required for the director and financial officer for labs planning to perform nonwaived testing.
State of Florida fees are due with application.
CLIA fees are billed separately by the CLIA program and payment must be sent to the separate address specified on the CLIA bill.
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Application Process (continued)
Testing is not authorized until the Florida clinical
laboratory license is received (for nonwaived testing).
On-site lab inspection is required for nonwaived tests
prior to being licensed; however, a paper survey is
accepted for nonwaived tests that are classified as
Provider Performed Microscopy (PPM).
A state application is also required 60 days prior to an
ownership change.
Questions? Call AHCA’s Clinical Laboratory Unit:
850-412-4500
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Renewals
Nonwaived State lab licenses must be renewed every two years.
A reminder is sent to the lab approximately 120 days prior to state license expiration.
The application and fees must be received by AHCA 60 days prior to the expiration date.
CLIA fees are billed separately for renewal of the CLIA certificate every two years.
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Federal CLIA Regulations
Title 42, Code of Federal Regulations, Part 493
CLIA internet site:
www.cms.hhs.gov/cliaSee “Interpretive Guidelines for Laboratories”
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State of Florida Regulations
Florida Statutes (F.S.): Chapter 483, Part I
Internet site: http://www.leg.state.fl.us
Florida Administrative Code, Chapter 59A-7
Internet site: https://www.flrules.org
Health Care Licensing General Provisions: under sections 408.801 to 408.832, F.S.
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1. Hematology Analyzer (CBC with 3 part differential)
2. Immunoassay: 40 different assays
3. Chemistry Analyzer (9 tests)
4. Urinalysis: 10 analytes per reagent strip
The same
regulations apply
to both small labs
using small
equipment and…
1
2
34
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Hematology Analyzer
… large labs
using high
volume
equipment.
Chemistry
Analyzer
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Who can order lab tests?
Medical Doctors (MD)
Osteopathic Physicians (DO)
Chiropractors (DC)
Podiatrists (DPM)
Naturopaths
Nurse Practitioners (ARNP)
Dentists (DDS)
Nurse Midwives (CNM)
(Reference: section 483.041(7), Florida Statutes)
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Florida Lab License
License
Nonwaived testing (plus any of the waived tests are
also allowed)
Specific lab specialties performed are listed on the
license (Provider Performed Microscopy,
Hematology, Chemistry, etc.)
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Types of CLIA Certificates
Certificate of Waiver (Type 2)
Certificate for Provider Performed Microscopy Procedures (Type 4)
Certificate of Registration (Type 9) – an initial “temporary” certificate before receiving one of the following:
Certificate of Compliance (Type 1) or
Certificate of Accreditation (Type 3)
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Certificate of Waiver
Includes tests such as urine dipsticks,
fingerstick blood sugar, certain rapid strep
kits and other waived tests
Includes only tests categorized as CLIA
waived
New waived tests added periodically
Does not include any microscopy tests
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Certificate of Waiver (continued)
More than half of existing labs are performing
only waived tests.
No minimum qualifications for personnel.
No on-site survey (inspection) is required unless
the lab is randomly selected for small percentage
of waived lab surveys that are performed for
CLIA each year or unless a complaint is filed.
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Certificate for Provider Performed
Microscopy (PPM) Procedures
Certain microscopy tests may be performed by a licensed physician, ARNP, certified midwife, or physician’s assistant
Examples of PPM tests: wet mounts, KOH preps, urine microscopy and certain other tests
CLIA internet site listing PPM tests: http://www.cms.gov/CLIA/10_Categorization_of_Tests.asp
Specific allowed PPM tests are listed on the CLIA web page (also in section 493.19 of the CLIA regulations)
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Provider Performed Microscopy (continued)
Any waived tests are also allowed to be
performed with every type of CLIA certificate.
Requires a Microscopy Evaluation Survey which
is an off site self-evaluation survey that meets
the requirement for a state-only inspection for
this testing since it is nonwaived.
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Certificate of Compliance
Includes testing above the level of waived or
Provider Performed Microscopy
Any waived tests are also allowed.
Tests are categorized as moderate complexity or
high complexity.
Examples include: CBC testing (Hematology),
Chemistry tests using a nonwaived analyzer,
throat or urine cultures (Bacteriology) and
others.
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Certificate of Compliance (continued)
The lab initially receives a “Certificate of Registration”
following payment of the initial CLIA fee.
On-site survey is performed by AHCA initially, prior to
patient testing, then every two years.
The relicensure/recertifiation survey is performed at
least 6 months prior to the CLIA expiration date.
CLIA compliance fees are billed one year prior to the
expiration and must be paid prior to survey.
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Certificate of Accreditation
Same as a Certificate of Compliance exceptthe lab has chosen to apply for accreditation with one of the approved organizations.
It is an option and not a requirement for a lab to be accredited (by COLA, College of American Pathologists or Joint Commission).
If the lab chooses not be accredited, then the lab changes its certificate type to a Certificate of Compliance.
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Certificate of Accreditation (continued)
The accrediting organization performs the
inspection and submits a report to AHCA.
Fees to AHCA and CLIA are reduced since
AHCA is not performing the inspection and the
lab pays a fee to the accrediting organization.
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Accrediting Organizations
AABB (American Association of Blood Banks)
AOA (American Osteopathic Association)
ASHI (American Society of Histocompatibility and Immunogenetics)
CAP (College of American Pathologists)
The Joint Commission
COLA (Commission on Laboratory Accreditation)
(List from www.cms.hhs.gov/clia)
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Requirements for waived testing
CLIA Certificate of Waiver (state lab license for only waived testing is not required as of 7/1/09).
Follow manufacturer’s instructions and document tests performed.
Waived labs are not inspected except on a random basis, or because of a complaint, for the CLIA program (COW surveys for Certificate of Waiver).
(Reference: 59A-7.021(9), FAC and
493.15 and 493.35, CFR)
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When can one CLIA certificate
cover multiple locations?(1) Laboratories that are not at a fixed location, i.e., 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 CLIA certificate and address of the designated
primary site or home base.
(2) A not-for-profit or federal, state, or local government laboratories that
engage in limited (not more than a combination of 15 types of
moderately complex or waived tests per certificate) public health testing
may file a single application.
(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 CLIA certificate(s) for the
laboratory sites within the same physical location or street address.
(Reference: 493.35(b), Code of Federal Regulations)
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State License Requirements
Each separate lab location (each address) must have a separate license.
Hospitals may have locations on the same campus under one license.
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Nonwaived Labs must have:
Written policies and procedures for safety and sanitation
Biomedical waste permit from the Department of Health
(Reference: section 59A-7.023, F.A.C.;
for Biomedical Waste, this section refers to Section 381.0098, Florida Statutes)
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Collection Stations
must have:
• Written instructions for specimen handling
• Refrigerator; temp recorded daily (2-8o C)
• Patient name, ordering physician’s name, date
and time of collection, name of test(s)
ordered, date and time the specimen was
forwarded to the lab
Reference: section 59A-7.024, F.A.C.
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Collection Station specimen log
(accessioning records) must
contain:• Patient name
• Ordering physician’s name
• Date and time of collection
• Name of test(s) ordered
• Date and time the specimen was
forwarded to the lab
(Reference: section 59A-7.024(4)(b), F.A.C.)
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Proficiency Testing (PT)
Proficiency Testing: Unknown samples sent to the lab for testing.
Results are reported to the PT company who will grade them.
Independent companies supply PT samples three times per year.
PT companies approved by CMS and Florida on CMS web page: http://www.cms.gov/CLIA/14_Proficiency_Testing_Providers.asp#TopOfPage.
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Proficiency Testing Enrollment
Physician office labs must enroll in PT for CLIA regulated analytes.
For tests that do not require PT, there must be a method for verification of accuracy every 6 months (example: split patient sample for sending out to compare to your results).
Independent labs and hospital labs must enroll in PT for all nonwaived tests that they perform, if PT is available for that test.
(Reference: 59A-7.025, F.A.C.)
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PT failure for a
Physician Office Lab (POL)
POLs are asked to obtain technical training and
assistance when they fail two out of three
consecutive proficiency testing events.
Repeated failures are referred to the federal CLIA
office for action.
For a POL, Florida’s law states that PT
requirements will not exceed CLIA regulations.
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PT Referral Warning!
No proficiency testing samples can be referred
to another lab for testing!
PT Referral results in serious CLIA penalties
Loss of CLIA certificate for one year
Cancellation of Medicare/Medicaid
Lab director can’t direct any lab for 2 years
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Laboratory Quality Systems
Quality assessment through ongoing monitoring is required.
Problems must be identified, evaluated and resolved.
Total testing process must be monitored:
Preanalytic
Analytic
Postanalytic
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Preanalytic Requirements
Procedure Manual: Lab must follow written
procedures for specimen submission and
handling.
Test requisitions must have the required
information and only an “authorized person”
may order tests.
Requisitions must be retained for at least two
years.
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Analytic Requirements
Procedure manual must include:
• Specimen collection and handling
• Step-by-step instructions for each test
• Calibration and control procedures
• Criteria for life-threatening results (panic values)
and how to report
(Written manufacturer’s instructions and Operator’s Manual
may be used.)
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Test Records
Paper or electronic records
must include:
Patient ID number
Date and time of specimen receipt
If rejected, documented reason
Identity of personnel performing test
(Reference: 59A-7.028(4), F.A.C.)
Coulter counter with computer
interface for Complete Blood
Counts (CBCs)
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Specimen integrity and identification must
be maintained, as in this example:
Labeled blood tubes
Labeled blood smear
Blood smear examined
microscopically
Accurate
Final Report
Sample analyzed
on Hematology
instrument
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Verification of Performance
Specifications
Lab must document that they have verified the
manufacturer’s specifications:
Accuracy - How do samples with known values compare between different test
methods?
Precision - How much variation does the lab obtain when it runs the same
sample repeatedly?
Reportable Range - How low and how high can results be reported? Less than
and greater than would be used if the patient results showed they were higher
or lower than the reportable range.
Normal Values - What would be considered a normal result? What is
abnormally high or abnormally low? Normal values can vary between
differing types of patients, so the lab should adjust the normal value they
report based on the age and sex of the patient.
(cell counter)
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Maintenance and Function Checks
Follow manufacturer’s instructions Example: clean, replace sampling needles,
replace parts
Document maintenance
and function checks
(Reference: 59A-7.029, F.A.C.)
Hematology Analyzer for
CBC tests
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Calibration
and Calibration Verification
Must follow manufacturer’s instructions.
Calibration must be verified at least every 6
months (except for cell counters when two or
more levels of controls are tested daily).
(Reference: 59A-7.029, F.A.C.)
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Example of a Calibration Curve
Instrument readings are proportional to the patient’s result according to the “line” that
is created when calibrator samples with known values are run. The instrument is
measuring absorbance of samples-or amount of light absorbed by a sample with a
beam of light passing through it. The lab must calibrate (measure and make
adjustments) the instrument using calibrators (liquid in vials usually), then every six
months they must verify using a low, mid, and high control or calibrator to make sure
the instrument does not need an adjustment to the calibration again.
Instrument
reading
The concentration of
substance being
measured in the
sample
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Control Procedures
(Quality Control)
Once each day or with each run of patient specimens for nonwaived tests, the lab must:
Run two different levels of controls for each test.
Document results.
Take corrective action if control fails.
(Reference: 59A-7.029, F.A.C.)
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EQC (Equivalent Quality Control)
CLIA allows a reduction in frequency of external
controls if the machine has internal controls that
monitor the testing process.
(Reference: 493.1256(d), CFR)
(Reference: 59A-7.029, F.A.C.)
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Analytic Requirements
Certain tests and specialties have additional
requirements in the quality control section of
the regulations.
Examples:
Arterial blood gases (controls every 8 hours and
one with each patient run)
Coagulation tests (every 8 hours)
Histopathology special stains (each time of use)
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Postanalytic Systems
Test Report must include:
Patient name and ID number
Name and address of testing lab
Report date
Test name
Source of specimen as needed
Test result (with interpretation as needed)
(Reference: 493.1291, CFR and 59A-7.028(5), F.A.C.)
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Personnel Requirements in a POL
Must comply with federal CLIA personnel requirements and do not need to meet higher Florida lab personnel requirements.
Florida lab personnel licensure from the Board of Clinical Laboratory Personnel is required for hospital labs and independent labs, but not required for testing personnel in a POL performing testing for only their own patients.
(Reference: 493.1351 through 493.1495, CFR)
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Lab Personnel
• Training, experience, and competency testing
must be documented.
• Minimum of a high school diploma is required
for performing moderate complexity testing in a
Physician’s Office Lab.
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Laboratory Director for moderate
complexity testing in a POL
Must meet CLIA director qualifications:
Current state license to practice medicine
Lab training or experience meeting one of the following:
One year directing or supervising non-waived laboratory testing, or
20 continuing education credit hours in lab practice/director responsibilities
Lab training equivalent to 20 credit hours obtained during residency
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Florida Clinical Laboratory Fees
Biennial fees based on type and volume of testing:
Nonwaived accredited lab = $100
Nonwaived nonaccredited varies from
$400 up to $3919 based on volume of testing:
Examples: Up to 2,000 tests per year = $400
2001 to 10,000 tests per year = $965
More than 1,000,000 tests per year = $3919
(Reference: 483.172, F.S. & 59A-7.036 F.A.C.)
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Federal CLIA Fees
Also based on type and volume of testing
Billed to labs by federal CLIA program initially
and every two years
Certificate of Waiver: $150
Certificate of Provider-performed Microscopy: $200
Non-waived labs: Total biennial fee varies from
$450 to $10,998 for nonaccredited fees based on
total annual test volume (accredited labs pay a
reduced fee since their inspection is performed by an
accrediting organization)
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AHCA On-site Survey
Announced about two weeks in advance for physician
office labs who have a Certificate of Compliance.
The inspection of the lab is an “outcome oriented”
survey to ensure compliance with CLIA and State of
Florida requirements.
The lab should stay ready for an “inspection” at all
times.
The lab may request to cancel and reschedule the
routine inspection no more than twice.
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Clinical Laboratory Surveys
If deficiencies are found, a written Statement of
Deficiencies is sent to the lab.
The lab is asked to write a plan of correction to
correct the deficiencies and submit it to AHCA
within a given timeframe.
AHCA may perform an on-site revisit to ensure
compliance.
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Lab Surveys
The Clinical Laboratory surveyor will ask
to review laboratory records such as: Proficiency Testing records and results
Procedure manual
Documentation of equipment maintenance, quality control results
Personnel qualifications, training,
Annual competency evaluations, and
Patient test reports contained in patient charts
483.245, Florida Statutes Rebates prohibited;
penalties
Under section 483.245, F.S. - Rebates
prohibited; penalties:
It is unlawful for any person to pay or receive any
commission, bonus, kickback, or rebate or engage in
any split-fee arrangement in any form whatsoever
with any dialysis facility, physician, surgeon,
organization, agency, or person, either directly or
indirectly, for patients referred to a clinical
laboratory licensed under this part.
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59A-7.020(14), F.A.C. Definition of
Kickback
Under 59A-7.020(14): (14) Kickback – a remuneration,
payment back, or other inducement, direct or indirect,
in cash or in kind, pursuant to an investment interest,
compensation arrangement, or otherwise, made by any
person as defined in Section 483.041(7), F.S., including
any clinical laboratory as defined in Section 483.041(2),
F.S., to any physician, surgeon, organization, agency, or
person as an incentive or inducement to refer any
individual or specimen to a laboratory licensed under
Chapter 483, Part I, F.S.
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59A-7.020(14) F.A.C. Examples of Kickbacks
Examples are:
Provision of an actual payment or investment
interest
Rental of real estate or equipment where the lease
agreement does not comply with the criteria set
forth in Section 456.053, F.S.
Provision of computer equipment and office
supplies with some allowances for laboratory
specimens and transmission of lab information
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59A-7.020(14), F.A.C. (continued)
Removal and disposal of biomedical waste
Provision of personal protection supplies and
equipment, except that gloves are permitted
Provision of test kits, systems or other laboratory
supplies
Provision of personnel or assistance of any kind to
perform any duties for the collection or processing
of specimens
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59A-7.037, F.A.C. Rebates Prohibited -
Penalties
Under 59A-7.037 Rebates Prohibited –
Penalties: No owner, director, administrator,
physician, surgeon, consultant, employee,
organization, agency, representative, or person
either directly or indirectly, shall pay or receive
any commission, bonus, kickback, rebate or
gratuity or engage in any split fee arrangement in
any form whatsoever for the referral of a
patient.
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59A-7.037, F.A.C. Rebates Prohibited –
Penalties (continued)
Any violation of Rule 59A-7.037, F.A.C., by a
clinical laboratory or administrator, physician,
surgeon, consultant, employee, organization,
agency, representative, or person acting on
behalf of the clinical laboratory will result in
action by the agency under Section 483.221,
F.S., up to and including revocation of the
license of the clinical laboratory.
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59A-7.037, F.A.C. Rebates Prohibited –
Penalties (continued)
No licensed practitioner or licensed facility is
permitted to add to the price charged by any
laboratory except for a service or handling charge
representing a cost actually incurred as an item of
expense. However, the licensed practitioner or
licensed facility is entitled to fair compensation for
all professional services rendered. The amount of
the service or handling charge shall be clearly noted
in the bill to the patient.
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59A-7.037, F.A.C. Rebates Prohibited –
Penalties (continued)
Each licensed laboratory shall develop a fee
schedule for laboratory services which shall be
available to the patient, the authorized person
requesting the test or agency upon request.
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Questions?
http://ahca.myflorida.com/labs
Contact AHCA Laboratory Unit at
(850) 412-4500 or via e-mail