(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 C.F.R. 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 Florida Statutes § 483.811, 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 Florida Statutes Chapter 483, Part II, 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 Florida Statutes § 381.0035 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 Florida Statutes Chapter 401;
    (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 Florida Statutes Chapter 464;
    (IV) Is licensed as a radiologic technologist pursuant to Florida Statutes Chapter 468, Part IV;
    (V) Is licensed as a respiratory care practitioner certified in critical care services or a respiratory therapist pursuant to Florida Statutes Chapter 468, Part V;
    (VI) Is licensed as a director, supervisor, technologist or technician pursuant to Florida Statutes Chapter 483, Part II, 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. History-New 8-15-18, Amended 10-10-19.