Fla. Admin. Code R. 59A-3.242
(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.
(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.
(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.
(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:
(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.
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 HYPERLINK "http://www.flrules.org/Gateway/reference.asp?No=Ref-10652" 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:
(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.
(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.
(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.
Rulemaking Authority 395.0091, 395.1055 FS. Law Implemented 395.0091, 395.1055 FS. History–New 8-15-18, Amended 10-10-19.