Final Adopted Rule effective October 30, 2011, and is available at: https://www.flrules.org/gateway/RuleNo.asp?title=CLINICAL LABORATORIES&ID=59A-7.034

59A-7.034 Alternate-Site Testing.
(1) Agency Intent: This rule implements Section 483.051(9), F.S., regarding criteria for alternate-site testing to be preformed under the supervision of a clinical laboratory director.
(2) Location and Required Licensure of Alternate-Site Testing: All alternate-site testing must be performed on the same or adjoining grounds, and on the physical premises of, the hospital facility licensed under Chapter 395, F.S. Alternate-sites are sites that are located outside of the physical or administrative confines of the central laboratory, but still under the administrative control of the hospital.
(a) Hospitals may hold more than one clinical laboratory license. For each clinical laboratory license held by the hospital, a licensed clinical laboratory director must supervise the laboratory and any alternate-sites of that licensed laboratory.
(b) The laboratory must be licensed in all specialties or subspecialties in which testing is performed at the alternate-sites. Testing at these sites shall be limited to those tests for which the laboratory director or designated supervisory laboratory personnel are licensed pursuant to Chapter 64B3, F.A.C., and authorized under Chapter 59A-7, F.A.C.
(c) Alternate-site locations must be listed on any hospital clinical laboratory licensure application submitted to the Agency.
(3) Supervision of Alternate-Site Tests: All alternate-site tests must be performed under the supervision of the clinical laboratory director who is responsible for all laboratory testing conducted under the hospital’s clinical laboratory license(s).
(4) Hospital Internal Needs Assessment:
(a) The laboratory director in consultation with the appropriate medical staff shall prepare an internal needs assessment for alternate-site testing. Each testing site 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 to determine if the requirements listed in subsections (7) through (9) are met.
(b) The selection of alternate-site test methods shall assure that performance and operational characteristics meet the clinical requirements for the intended alternate-site testing location. The internal needs assessment shall include an evaluation of proposed methodologies for tests to be performed at the alternate-sites composed, at a minimum, of evaluation of accuracy, precision, comparison of test results with the hospital laboratory, instrument performance, maintenance requirements, reagent preparation, if applicable, storage and availability of supplies such as reagents, controls and proficiency samples for the testing site and a written validation procedure.
(c) Alternate-site testing shall only be conducted at sites where the director has established and documented in the internal needs assessment that such testing is necessary for the proper care and treatment of patients.
(d) The internal needs assessment must be reviewed and approved by the laboratory director prior to initiation of testing at any alternate-test site and biennially thereafter.
(e) 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.
(5) Written Protocols and Quality Assurance Programs:
(a) A written protocol shall be established by the laboratory director and implemented according to the service(s) being performed at the alternate-site as required under subsection 59A-7.029(3), F.A.C., applicable to tests performed.
1. There shall be a procedure manual at each site where alternate-site testing is performed.
2. The alternate-site procedure manual shall specifically address the alternate-site testing done at that location.
3. The procedure manual shall be reviewed and signed, documenting that it has been reviewed biennially by the laboratory director.
(b) The laboratory director is responsible for developing a quality assurance program that is appropriate for the test methods used at the alternate-testing site as required under Rule 59A-7.031, F.A.C. 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.
(c) The laboratory must maintain the capability of verifying the validity of test results obtained at the alternate-test site as specified in Rule 59A-7.029, F.A.C.
(6) Recordkeeping Requirements:
(a) All records of personnel authorized to perform 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. These records shall include the name of each person performing such testing and documentation that each individual performing alternate-site testing is licensed by the state or certified by a national organization in a health care profession as required in subsection 59A-7.034(8), F.A.C., initial and ongoing competency evaluations, in-service training, and any corrective actions.
(b) Results of all testing performed shall be made a part of the patient’s permanent medical record and shall meet the requirements specified in Rule 59A-7.028, F.A.C.
(c) Records of alternate-site tests, testing locations, quality control, evaluation of accuracy, precision, correlation studies, instrument performance, instrument maintenance, and the internal needs assessment for the tests, must be maintained for a minimum of two years after testing is discontinued and available to any surveying agency including an accrediting organization if the laboratory is accredited.
(7) Alternate-Site Testing Personnel Requirements: Staff performing the testing at these alternate-sites, as authorized under this subsection, are not required to be licensed under Chapter 483, Part III , F.S., as clinical laboratory personnel.
(a) 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-test site locations shall meet one of the following requirements:
1. Is licensed as an advanced registered nurse practitioner, a registered nurse or licensed practical nurse pursuant to Chapter 464, F.S.,
2. Is licensed as a radiologic technologist pursuant to Chapter 468, Part IV, F.S.,
3. Is licensed as a respiratory care practitioner certified in critical care services or a respiratory therapist pursuant to Chapter 468, Part V, F.S.,
4. 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),
5. Is licensed as a physician assistant pursuant to Chapter 458 and 459, F.S.,
6. Is a perfusionist certified by the American Board of Cardiovascular Perfusion, 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.
7. Is a cardiovascular technician certified by the Cardiovascular Credentialing International (CCI),
8. Is licensed as a director, supervisor, technologist or technician under Chapter 483, Part III, F.S., or exempt from such licensure as provided in that chapter,
9. Is a licensed Emergency Medical Technician (EMT) or Paramedic pursuant to Chapter 401, F.S., or
10. Meets the staff training and education requirements set out in the alternate-site policy and procedure manual developed by the laboratory director for individuals performing tests categorized as waived. Individuals who meet such staff training and education requirements for performing tests categorized as waived, but who do not meet the requirements for performing moderate complexity tests as provided under this rule, are restricted to performing tests categorized as waived.
(b) The laboratory director will determine if the above listed personnel are suitable to perform testing at the alternate-site. The laboratory director shall:
1. Ensure that testing personnel are limited to those who meet the requirements of paragraph 59A-7.034(7)(a), F.A.C., and
2. 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 including infection control procedures;
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 infection control procedures; and
j. Demonstration of knowledge of reporting procedures for life threatening results.
(c) 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 paragraph (c), above.
(8) Responsibilities of the Laboratory Director Pertaining to the Alternate-Test Site:
(a) 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.
(b) Evaluation of competency for alternate-site testing personnel must be performed prior to initiation of patient testing and at least annually thereafter.
(c) Documentation of licensure or certification, as applicable, pursuant to subsection 59A-7.034(8), F.A.C., and competency evaluations must be maintained during the tenure of all testing personnel and for a minimum of two years thereafter and made available to the agency at the time of inspection.
(9) Tests Performed: Only test procedures approved by the clinical laboratory director and documented in the internal needs assessment in accordance with Rule 59A-7.034, F.A.C., shall be performed at the alternate-test site.
(a) Tests performed at these sites shall not exceed moderately complex test procedures and must:
1. Employ specimens that require no manual specimen or reagent manipulation, treatment, extraction, centrifugation, separation or any other processing of any kind by the operator, as determined by the clinical laboratory director; and
2. Utilize automated test systems in which a specimen is directly introduced into the system. Such instrumentation shall automatically provide for instrument calibration without access by the operator to modify or adjust calibration limits. If the instrument has a requirement to establish quality control ranges, the ranges must be established by appropriately licensed clinical laboratory personnel.
(b) Alternate-test sites are also permitted to perform moderately complex testing on bodily fluids such as amniotic fluid, which require minimal preparation as determined by the laboratory director.
(c) 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.
(d) Electronic instrumentation must have a mechanism whereby the operator is alerted 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 as required under Rule 59A-7.029, F.A.C., and shall be validated through the central laboratory.
(10) The Agency shall take administrative action pursuant to Sections 483.201, 483.221, 408.806, 408.813, 408.814, 408.816 and 483.23, F.S., where the agency determines that said sites have operated in violation of Chapter 483, Part I, F.S., Chapter 408, Part II, and the provisions of Chapter 59A-7 and Chapter 59A-35, F.A.C. In addition, pursuant to Sections 408.813, 408.814, 408.816, 483.201, 483.221 and 483.23, F.S., in the event of such a violation, the Agency shall take administrative action up to and including revocation of the laboratory license of the laboratory maintaining the alternate-testing site.
Rulemaking Authority 483.051, 408.819 FS. Law Implemented 408.806, 408.813, 408.814, 408.816, 483.051, 483.181, 483.201, 483.221, 483.23 FS. History–New 12-27-95, Amended 12-8-09, 12-29-10, 10-30-11.

Presentation on Ocotber 30, 2011 changes to the rule