Florida Administrative Code
59 - AGENCY FOR HEALTH CARE ADMINISTRATION
59A - Health Facility and Agency Licensing
Chapter 59A-3 - HOSPITAL LICENSURE
Section 59A-3.242 - Laboratory, Radiology, and Respiratory Services
Universal Citation: FL Admin Code R 59A-3.242
Current through Reg. 50, No. 187; September 24, 2024
(1) Clinical and Pathology Laboratory Services. Each hospital must 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 Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed. Hospitals may operate more than one CLIA certified laboratory. Each hospital laboratory shall have a qualified laboratory director. Qualifications for laboratory director, supervisor, technologist, and technician are found in Chapter 483, part II, F.S., and the rules adopted thereunder.
(a) The laboratory
director is responsible for the supervision of the laboratory, including
alternate-site testing locations, and shall maintain and enforce policies and
procedures for the provision of clinical and pathology laboratory
examinations.
(b) Provision shall
be made for assuring the availability of emergency laboratory services. Such
services shall be available 24 hours a day, seven days a week, including
holidays.
(c) Reports of all
examinations shall be filed with the patient's medical record.
(d) All specimens removed in operations shall
be examined by a pathologist, except when another suitable means of
verification of removal is routinely employed, when there is an authenticated
report to document the removal, and when quality of care will not be
compromised by the exception. Hospitals may establish a policy for excepting
certain categories of specimens from examination when it determines quality of
care will not be compromised or examination will yield no useful information.
Signed reports on all specimens removed in an operation, whether documented by
a pathologist or through an alternative means, shall be filed with the
patient's medical record.
(e) All
hospitals utilizing blood and blood products, shall:
1. Maintain facilities for procurement,
safekeeping and transfusion of blood and blood products, or have them readily
available.
2. Maintain a
temperature alarm system for blood storage facilities, where applicable, which
is tested and inspected quarterly and is otherwise safe.
3. The alarm system must be audible, and must
monitor proper blood and blood product storage temperature over a 24-hour
period.
4. Tests of the alarm
system must be documented.
5. If
blood is stored or maintained for transfusion outside of a monitored
refrigerator, the hospital must ensure and document that storage conditions,
including temperature, are appropriate to prevent deterioration of the blood or
blood product.
6. Promptly dispose
of blood which has exceeded its expiration date.
7. Records shall be kept on file indicating
the receipt and disposition of all blood provided to patients in the
facility.
(f) Hospitals
not utilizing blood and blood products need not maintain blood storage
facilities.
(g) Alternate-site
testing locations (alternate-sites) 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 (hospital laboratory), but still
under the administrative control of the hospital and under the supervision of
the laboratory director. Each hospital laboratory may operate more than one
alternate-site.
1. Hospitals must register
their alternate-sites at license renewal by submitting a hospital licensure
application as specified in subsection
59A-3.066(2),
F.A.C. and attaching AHCA Form 3130-8013, July 2018, License Application
Alternate-Site Testing, herein incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-10652.
2. Testing at alternate-sites shall not
exceed test categorization of moderate complexity as described in Title 42 CFR
Part 493.17 and administered by the Centers for Medicare and Medicaid Services
and shall be limited to those tests:
a. Within
the specialties and subspecialties for which the laboratory is CLIA certified
and the laboratory director or supervising delegate is qualified;
b. Approved by the laboratory director and
documented in the internal needs assessment;
c. Utilizing instrumentation in which
instrument calibration is performed automatically without access by the
operator to modify or adjust calibration limits, and if the instrumentation has
a requirement to establish quality control ranges, the ranges must be
established by licensed clinical laboratory personnel under the supervision of
the laboratory director; and
d.
Requiring a specimen to be directly introduced into the instrumentation without
manual specimen or reagent manipulation, treatment, extraction, centrifugation,
separation or other processing of any kind by the operator, except for bodily
fluids such as amniotic fluid, requiring minimal preparation as approved by the
laboratory director and documented in the internal needs assessment and
procedure manual.
3. The
laboratory director in consultation with the appropriate medical staff shall
prepare an internal needs assessment for each alternate-site. Each assessment
shall include an evaluation of patient benefits and criteria for such testing,
location of alternate-site, population to be served, and an evaluation of
proposed instruments or testing methodologies.
a. The selection of alternate-site test
methods shall assure that performance and operational characteristics meet the
clinical requirements for the intended location. Alternate-site testing shall
only be conducted at sites where the laboratory director has established and
documented in the internal needs assessment that such testing is necessary for
the proper care and treatment of patients.
b. The internal needs assessment must include
an evaluation of proposed methodologies for tests to be performed at the
alternate-sites composed of evaluation of accuracy, precision, reportable range
and reference interval studies, comparison of test results with the hospital
laboratory, instrument performance, maintenance requirements, storage and
availability of supplies such as reagents, controls and proficiency samples for
the testing site and a written validation procedure.
c. The internal needs assessment must be
reviewed and approved by the laboratory director prior to initiation of testing
at any alternate-site and biennially thereafter. All records related to the
internal needs assessment for the purpose of alternate-site testing must be
readily available for inspection by the Agency and any other surveying agency
including accrediting organizations, if the laboratory is accredited, for a
minimum of two years after testing is discontinued.
4. A written protocol shall be established by
the laboratory director and implemented according to the service(s) being
performed at the alternate-site applicable to tests performed.
a. There shall be a procedure manual at each
alternate-site which shall specifically address the tests performed at that
location. The procedure manual shall be reviewed and signed by the laboratory
director biennially.
b. There shall
be a quality assurance program that is appropriate for the test methods used at
the alternate-site. Criteria for repeating a result or obtaining a sample for
assay in the hospital laboratory must be outlined by the director and included
in the quality assurance program. The hospital laboratory must maintain the
capability of verifying the validity of test results obtained at
alternate-sites.
5.
Records of alternate-site tests, locations, quality control, evaluation of
accuracy, precision, correlation studies, instrument performance, and
instrument maintenance must be maintained for a minimum of two years after
testing is discontinued and available to any surveying agency including an
accrediting organization if accredited.
6. All records of personnel authorized to
perform testing at an alternate-site must be readily available for inspection
by the Agency and any other surveying agency including accrediting
organizations, if accredited. The records must be maintained during the tenure
of all testing personnel and for a minimum of two years thereafter. The records
shall include the name of each person performing testing, copies of
professional licensure or certification, initial and ongoing competency
evaluations, in-service training, and any corrective actions.
a. Successful completion of a training
program approved by the Board of Clinical Laboratory Personnel provided under
Section 483.811, F.S., shall meet the
minimum training requirements specified in this rule.
b. Personnel authorized to perform testing at
an alternate-site, as authorized under this subsection, are not required to be
licensed under Chapter 483, Part II, F.S., as clinical laboratory
personnel.
c. Individuals who meet
the CLIA requirements for performing tests categorized as waived, but do not
meet any of the testing personnel requirements of this rule are restricted to
performing tests categorized as waived.
d. Testing personnel shall have a high school
diploma, or its equivalent, and have met the HIV/AIDS educational requirements
pursuant to Section 381.0035, F.S. In addition, all
testing personnel in the alternate-site shall meet one of the following
requirements:
(I) Is licensed as an emergency
medical technician or paramedic pursuant to Chapter 401, F.S.;
(II) Is licensed as a physician assistant or
anesthesiologist assistant pursuant to Chapters 458 or 459, F.S.;
(III) Is licensed as an advanced practice
registered nurse, a registered nurse or licensed practical nurse pursuant to
Chapter 464, F.S.;
(IV) Is licensed
as a radiologic technologist pursuant to Chapter 468, Part IV, F.S.;
(V) Is licensed as a respiratory care
practitioner certified in critical care services or a respiratory therapist
pursuant to Chapter 468, Part V, F.S.;
(VI) Is licensed as a director, supervisor,
technologist or technician pursuant to Chapter 483, Part II, F.S., or exempt
from such licensure as provided in that chapter;
(VII) Is a phlebotomist certified by the
American Society of Clinical Pathologists (ASCP), National Certification Agency
for Medical Laboratory Personnel (NCA), American Society of Phlebotomy
Technicians (ASPT) or American Medical Technologists (AMT);
(VIII) Is a clinical laboratory assistant
certified by the AMT or American Society for Clinical Laboratory Science, or is
a medical laboratory assistant certified by the ASCP;
(IX) Is a perfusionist certified or
determined eligible for certification by the American Board of Cardiovascular
Perfusion, or has two years of clinical experience in cardiovascular perfusion
with 100 clinical perfusions conducted as of January 1, 1981; or
(X) Is a cardiovascular technician certified
by the Cardiovascular Credentialing International (CCI).
e. The laboratory director will determine if
the above listed personnel are suitable to perform testing at the
alternate-site. The laboratory director shall:
(I) Ensure that testing personnel are limited
to those who meet the requirements of this rule; and
(II) Establish methods for the evaluation of
competency to verify that alternate-site testing personnel perform procedures
and report tests results promptly and accurately. Evaluation of competency
shall include:
(A) Specimen collection,
handling and storage;
(B) Skills
required to perform the test method;
(C) Skills required to perform preventive
maintenance, troubleshooting, and calibration procedures applicable to the
testing methodologies;
(D)
Demonstration of knowledge of reagent stability and storage applicable to the
test system in use;
(E) Skills
required to implement quality control policies and procedures and evaluate
quality control results;
(F) An
awareness of factors that influence test results;
(G) Skills required to assess and verify the
validity of patient test results through the assessment of quality control
testing outcomes;
(H) Demonstration
of knowledge of patient preparation for each test performed;
(I) Demonstration of knowledge of standard
precautions; and
(J) Demonstration
of knowledge of reporting procedures for life threatening
results.
f. The
laboratory director shall ensure validation of personnel competency, which
shall include review of test results, quality control records, proficiency
testing results and preventive maintenance records; direct observation of test
performance and instrument maintenance; and assessment of performance through
testing previously analyzed specimens, internal blind samples, or proficiency
testing samples.
g. Evaluation of
competency for alternate-site testing personnel must be performed prior to
initiation of patient testing and annually thereafter.
7. Data output must be directly reportable in
the final units of measurement needed for patient care without need for data
conversion or other manipulation, with the exception of heparin concentration,
heparin assay, heparin dose response and thrombelastograph tests, which shall
be interpreted by the attending physician.
8. When patient results exceed the reportable
operating range of the test method and when calibration is not acceptable, such
results shall not be used for the diagnosis, treatment, management or
monitoring of patients and shall be validated through the hospital
laboratory.
(2) Radiology Services. Each Class I and Class II hospital shall provide on the premises, and each Class III hospital shall provide on the premises or by contract, diagnostic imaging facilities commensurate with the hospital's needs. The radiology department or similarly titled unit shall have a radiologist to serve as medical director on a full time or part time consulting basis to discharge professional radiology services.
(a)
The radiology department or other similarly titled part shall be maintained
free of hazards for patients and personnel.
(b) Each hospital shall have certified
radiologic technologists or basic x-ray machine operators in hospitals of 150
beds or less, and shall be on duty or on call at all times.
(c) The use of all diagnostic imaging
apparatus shall be limited to Florida licensed or certified individuals working
within their scope of practice, as determined by their regulatory
board.
(d) The credentials of each
person providing diagnostic and therapeutic radiation, imaging and nuclear
medicine services, including formal training, on-the-job experience, and
certification or licensure where applicable, shall be maintained on file at all
times.
(e) The medical director
shall maintain and enforce policies and procedures for the provision of all
diagnostic and therapeutic radiation, imaging, and nuclear medicine services.
Such policies and procedures shall be written, reviewed annually, and revised
as necessary, and shall be dated as to time of last review.
(f) The medical director shall require that
all radiology, imaging or nuclear medicine services be performed only upon
written order of a licensed physician or by another licensed health
professional if that health professional is acting within their scope of
practice as defined by applicable laws and rules of the licensing board.
Nothing herein shall be construed to expand or restrict such laws and rules
pertaining to the practice of various health professions. The request and all
results must be recorded in the patient's medical record;
(g) The medical director shall document all
misadministration of radioactive materials, as those terms are defined by
chapter 64E-5, F.A.C.
(h) The
medical director shall maintain and document in writing a quality control
program designed to minimize the unnecessary duplication of radiographic
studies, to minimize exposure time of patients and personnel, and to maximize
the quality of diagnostic information and therapy provided.
(3) Respiratory Therapy. Each hospital shall have written policies and procedures describing the scope of respiratory services provided to patients of the hospital. This document shall contain written guidelines for the transfer or referral of patients requiring respiratory care services not provided at the hospital.
(a) When respiratory care services are
provided outside the hospital, the hospital shall ensure by contract or other
enforceable mechanism that such services meet all safety requirements and
quality control measures required by the hospital.
(b) Respiratory care services provided within
a hospital shall have medical direction provided by a physician member of the
organized medical staff with special interest and knowledge in the management
of acute and chronic respiratory problems. The physician director shall be
responsible for the overall direction of respiratory services, for conducting a
review of the quality, safety and appropriateness of respiratory care services
quarterly, and shall be available for any required respiratory care
consultation.
(c) Respiratory care
services in a hospital may be supervised by a technical director who is
registered or certified by the National Board of Respiratory Care Inc., or has
the documented equivalent education, training and experience. Other respiratory
care personnel shall provide respiratory care commensurate with their
documented training, experience, and competence.
(d) The formal training of respiratory
therapy students shall be carried out only in programs accredited by
appropriate professional educational organizations. Individuals in student
status shall be directly supervised when engaged in patient care
activities.
(e) The education,
training and experience of personnel who provide respiratory care services
shall be documented, and shall be related to each individual's level of
participation in the provision of respiratory care services.
(f) Nonphysician respiratory care personnel
shall not perform patient procedures associated with a potential hazard,
including arterial puncture for obtaining blood samples, unless authorized in
writing by the physician director of the respiratory care service acting in
accordance with professional staff policy.
(g) The physician director shall be
responsible for ensuring all personnel providing respiratory care services
participate in education programs designed to augment the personnel's knowledge
of pertinent new developments in respiratory care services and maintain current
competency. Such participation shall occur annually, and shall include
instruction in safety, infection control, and cardiopulmonary
resuscitation.
(h) There shall be
written policies and procedures specifying the scope and conduct of patient
care rendered in the provision of respiratory care services. All policies and
procedures must be approved by the physician director, reviewed annually,
revised as necessary, dated to indicate the time of last review, and enforced.
Respiratory care policies shall include the following:
1. Specification as to who may perform
specific procedures and provide instruction, under what circumstances, and
under what degree of supervision.
2. Assembly and sequential operation of
equipment and accessories to implement therapeutic regimens.
3. Steps to be taken in the event of adverse
reactions, and other emergencies.
4. Procurement, handling, storage and
dispensing of therapeutic gases.
5.
Infection control measures, including specifics as to changing and cleansing of
equipment.
6. Administration of
medications in accordance with the physician's order.
(i) The respiratory care service shall have
equipment and facilities to assure the safe, effective and timely provision of
respiratory care service to patients.
1. All
equipment shall be calibrated and operated according to manufacturer's
specifications, and shall be periodically inspected and maintained.
2. Where piped-in gas is used, an evaluation
shall be made prior to use to assure identification of the gas and its delivery
within an established safe pressure range.
3. Ventilators used for continuous assistance
or controlled breathing shall have operative alarm systems at all
times.
(j) Prescriptions
for respiratory care shall specify the type, frequency and duration of
treatment and, as appropriate, the type and dose of medication, the type of
dilutent, and the oxygen concentration, and shall be incorporated into the
patient's medical record.
Rulemaking Authority 395.0091, 395.1055 FS. Law Implemented 395.0091, 395.1055 FS.
New 8-15-18, Amended 10-10-19.
Disclaimer: These regulations may not be the most recent version. Florida may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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