59A-7.020: Definitions
PURPOSE AND EFFECT: The agency is proposing to amend the rule that defines laboratory terms to remove definitions that are currently in statute, correct a federal agency name, update the rule to reference current regulations and terminology, and add definitions for andrology and molecular pathology.
SUMMARY: Revisions to update the rule to reference current regulations, correct federal agency names, delete definitions in statute and define andrology and molecular pathology.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 483.051 FS.
LAW IMPLEMENTED: 483.041(7), 483.181, 483.245 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: January 13, 2010, 1:30 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room D, 2727 Mahan Drive, Tallahassee, Florida
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, (850)487-3109
THE FULL TEXT OF THE PROPOSED RULE IS:
59A-7.020 Definitions.
In addition to definitions set forth in Section 483.041, F.S., as used in this chapter the following terms shall mean:
(1) Andrology – a Florida clinical laboratory personnel licensure specialty for personnel qualified to perform clinical laboratory testing for fertility and reproductive technologies. Tests include but not are limited to hormone assays, semen analysis, and sperm antibodies.
(2)(1) Approved Accreditation Program – a non profit organization granted deemed status or a state licensure program granted exempt status by the Centers for Medicare and Medicaid Services Health Care Financing Administration under the federal Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder.
(3)(2) Approved Proficiency Testing Program – a proficiency testing program that meets the requirements specified in Rule 59A-7.026, F.A.C.
(4)(3) Accredited – refers to a laboratory accredited or licensed, as applicable, by an approved accreditation program.
(5)(4) Authorized Person – a person authorized by the laws of this State to order tests or receive test results or both.
(6)(5) Biomedical Waste – any solid or liquid waste which presents a threat of infection to humans as defined under subsection 64E-16.002(2) 10D-104.002(2), F.A.C.
(7)(6) Clinical and Laboratory Standards Institute or CLSI – the voluntary consensus organization that develops and disseminates standards, guidelines and best practices for clinical laboratories and the healthcare community. This organization was formerly known as the National Committee for Clinical Laboratory Standards (NCCLS).
(8)(7) Clinical Laboratory Improvement Amendments of 1988 and Federal Rules Adopted Thereunder – Section 353 of the Public Health Service Act known as the Clinical Laboratory Improvement Amendments of 1988 and Title 42-Public Health, Chapter IV, Part 493, Laboratory Standards, each incorporated by reference and referred to as CLIA, herein.
(8) Clinical Laboratory or Laboratory – a laboratory where examinations are performed on materials or specimens taken from the human body to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the assessment of a medical condition.
(9) Collection Station – a facility where materials or specimens are withdrawn or collected from patients or are assembled after being collected elsewhere, for subsequent delivery to a clinical laboratory for examination.
(9)(10) Director – a person qualified under Rules promulgated pursuant to Chapter 483, Part III IV, F.S., who is responsible for and assures the overall administration of the technical and scientific operations of a laboratory.
(10)(11) Direct Supervision – supervision by a director, supervisor, or technologist who is on the premises, and is available to the laboratory when test procedures are being performed.
(11)(12) Exclusive Use Laboratory – a clinical laboratory operated by one or more of the following exclusively in connection with the diagnosis and treatment of their own patients:
(a) through (e) No change.
(12)(13) Free-standing Histology, Oral Pathology, or and Cytology Center – any location outside a clinical laboratory licensed under Chapter 483, Part I, F.S., which is engaged in and limits its activities to the preparation of human cellular material for microscopic interpretation by laboratories licensed in the specialty of pathology or and subspecialties of histopathology, oral pathology, and cytology.
(13)(14) General Supervision – supervision by a director or supervisor who is responsible for the overall performance of laboratory testing.
(15) Kickback – a remuneration, payment back, or other inducement, direct or indirect, in cash or in kind, pursuant to an investment interest, compensation arrangement, or otherwise, made by any person as defined in Section 483.041(7), F.S., including any clinical laboratory as defined in Section 483.041(2), F.S., to any physician, surgeon, organization, agency, or person as an incentive or inducement to refer any individual or specimen to a laboratory licensed under Chapter 483, Part I, F.S., such as the following:
(a) Provision of an actual payment or investment interest;
(b) Rental of real estate or equipment where the lease agreement does not comply with the criteria set forth in Section 456.053 455.236, F.S.;
(c) through (f) No change.
(g) Provision of personnel or assistance of any kind to perform any duties for the collection or processing of specimens. Such personnel or assistance is authorized to be provided on a temporary basis for the collection of specimens at a patient’s residence. These collections must meet the requirements of Chapter 59A-7, F.A.C.
(14)(16) Kit – all components of a test that are packaged together.
(15)(17) License – shall refer to a licensure certificate or licensure certificate of exemption issued under Chapter 483, Part I, F.S.
(16)(18) Licensure Certificate – evidence of current licensure issued to a clinical laboratory upon application and qualification as required in this Rule and Chapter 483, Part I, F.S. Such license shall be issued for testing for one or more of the following specialties or subspecialties:
(a) Histocompatibility.
(b) Microbiology composed of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology, or Microbiology (Other).
(c) Diagnostic Immunology composed of the subspecialties of Syphilis Serology or General Immunology.
(d) Chemistry composed of the subspecialties of Routine Chemistry, Urinalysis, Endocrinology, or Toxicology or Chemistry (Other).
(e) Hematology.
(f) Immunohematology composed of the subspecialties of ABO Group & Rh Group, Antibody Detection (Transfusion), Antibody Detection (Non-Transfusion), Antibody Identification, or Compatibility Testing or Immunohematology (Other).
(g) Pathology composed of the subspecialties of Histopathology, Oral Pathology or Cytology.
(h) Clinical Cytogenetics.
(i) Radiobioassay
(j) Free-standing histology or cytology center limited to those activities described in subsection 59A-7.020(11)(12), F.A.C.
(k) Provider-performed microscopy tests limited to the CLIA category of Provider-Performed Microscopy tests found in 42 CFR 493.19(c)(1-9).
(19) Licensure Certificate of Exemption or Certificate of Exemption – evidence of current licensure issued to a laboratory upon application and qualification as stipulated in Section 483.106, F.S., when such facility performs only waived tests. Such license shall be issued authorizing testing only for specialties or subspecialties for a certificate of exemption.
(17)(20) Moderate Complexity Moderately Complex Test – procedures defined as moderate complexity moderately complex by the federal Centers for Medicare and Medicaid Services Health Care Financing Administration under the federal Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder.
(18) Molecular Pathology – a Florida clinical laboratory personnel licensure specialty for personnel qualified to perform clinical laboratory testing using molecular techniques. Techniques include but are not limited to immunohistochemistry, in situ hybridization, single nucleotide polymorphism and other mutational analysis sequencing, protein analysis, target signal amplification methods, cell culture and isolation, expression profiling, blotting and microarrays.
(19)(21) Performance Characteristic – a property of a test that is used to describe its quality including accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference range.
(20)(22) Performance Specification – a value or range of values for a performance characteristic, established or verified by the laboratory, that is used to describe the quality of patient test results.
(21)(23) Referee Laboratory – means a laboratory that has a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test, analyte, subspecialty, or specialty and has been designated by an approved proficiency testing program that meets the requirements of Rule 59A-7.026, F.A.C., as a referee laboratory analyzing proficiency testing specimens for the purpose of determining the correct response for the specimens in a testing event for that specific test, analyte, subspecialty, or specialty.
(22)(24) Reference Range – means the range of test values expected for a designated population of individuals.
(23)(25) Supervisor – a person licensed under Chapter 483, Part III IV, F.S., who is responsible for the day-to-day supervision or oversight of the technical and scientific operations in a laboratory specialty or who, under the general supervision of a director, supervises and evaluates the performance of technical personnel, performs tests requiring special scientific skill, performs functions delegated by the director, and who, in the absence of the director, is held responsible for proper performance of testing procedures, testing personnel, reporting of results and compliance with applicable regulations.
(24)(26) Sample – in proficiency testing means the material contained in a vial, on a slide, or other unit that contains material to be tested by proficiency testing program participants. When possible, samples are of human origin.
(25)(27) Separate Premises – buildings that are not located on the same or adjoining grounds.
(26)(28) Technologist – a person licensed under Chapter 483, Part III IV, F.S., who under the general supervision of the director or supervisor, processes specimens, performs and interprets tests that require the exercise of independent judgment and responsibility, and reports results in those specialties or subspecialties in which the technologist is licensed. A technologist is authorized to oversee the work of technicians in the absence of a supervisor in the specialty(ies) in which the technologist is licensed.
(27)(29) Technician – a person licensed under Chapter 483, Part III IV, F.S., who functions under the direct supervision of a director, supervisor, or technologist and performs routine clinical laboratory procedures which require limited responsibility and minimal exercise of independent judgment. A technician is authorized to function under general supervision in exclusive use laboratories.
(28)(30) Transfusion Service – for purposes of this part, a blood bank transfusion service shall include the collection of blood and blood components, performance of therapeutic collection or pheresis, preparation of red blood cells and the recovery of human plasma.
(29)(31) Target Value – for quantitative tests refers to the mean established by the approved proficiency testing program.
(30)(32) Unsatisfactory Proficiency Testing Performance – failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event.
(31)(33) Unsuccessful Proficiency Testing Performance – a failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two of three consecutive testing events.
(34) Waived Test – a test that the federal Health Care Financing Administration has determined qualifies for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder.
Rulemaking Specific Authority 483.051 FS. Law Implemented 483.035, 483.041, 483.051, 483.106, 483.191 FS. History–New 11-20-94, Amended 8-13-95, 12-27-95, 6-22-06,_________.