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

Current through Reg. 50, No. 138; July 16, 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.