The Board proposed the rule amendment to update requirements Clinical Laboratory Personnel Training Programs and to incorporate the initial and renewal applications.

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.:RULE TITLE:

64B3-3.001General Requirements of Clinical Laboratory Personnel Training Programs

PURPOSE AND EFFECT: The Board proposed the rule amendment to update requirements Clinical Laboratory Personnel Training Programs and to incorporate the initial and renewal applications.

SUMMARY: Requirements of Clinical Laboratory Personnel Training Programs will be updated and the initial and renewal applications will be incorporated into the rule.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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.

RULEMAKING AUTHORITY: 483.805(4), 483.811(2) FS.

LAW IMPLEMENTED: 483.807, 483.809, 483.811 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Anthony Spivey, Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B3-3.001 General Requirements of Clinical Laboratory Personnel Training Programs.

(1) Each clinical laboratory personnel training program, hereinafter referred to as program, shall apply to the board for initial approval on Form #DH-MQA 3007 (02/18 3/16) “Initial and Renewal Application for Clinical Laboratory Personnel Training Program,” http://www.flrules.org/Gateway/reference.asp?No=Ref-          06932, which is incorporated by reference herein and pay the fee set forth in subsection 64B3-9.001(3), F.A.C. For renewal, each clinical personnel training program shall apply for renewal to the board on Form DH5030-MQA (02/2018) “Renewal Application for Clinical Laboratory Personnel Training Program, http://www.flrules.org/Gateway/reference.asp?No=     , which is incorporated by reference herein and pay the fee set forth in subsection 64B3-9.004(6), F.A.C.

(2) No change.

(3)(a) Programs shall submit a self study at the time of the initial application and shall update the self study within six (6) months of any major change in curriculum, sponsorship, faculty, student enrollment or clinical sites. The self study document shall be prepared on a form provided by the Department entitled “Clinical Laboratory Training Program Self Study Document,” DH1261 10/98, effective 1-11-99, which is hereby incorporated by reference and may be obtained from the Board office. If the program is accredited by the National Accrediting Agency for Clinical Laboratory Science (NAACLS), the Council on Accreditation of Allied Health Education Programs (CAAHEP), or the Accrediting Bureau of Health Education Schools (ABHES), proof of accreditation verification documentation from the National Accrediting Agency for Clinical Laboratory Science (NAACLS), the Council on Accreditation of Allied Health Education Programs (CAAHEP), or the Accrediting Bureau of Health Education Schools (ABHES). may be substituted in lieu of the self study document.

(b) Programs that are nationally accredited or pending national accreditation shall only be required to submit proof of accreditation status with the application.

(4) No change.

(5) Each training program shall:

(a) No change.

(b) Maintain copies of inspection and approval by the fire department or the state fire marshal’s office and provide them for inspection upon request.

(c) through (d) re-designated (b) through (c) No change.

(d)(e) Provide the student with a certificate or letter of graduation or a transcript indicating the degree granted. Certificates or and letters of graduation shall include the program’s license number and be signed by the program director.

(f) through (g) re-designated (e) through (f) No change.

(g)(h) Upon initial application and at each biennial renewal, the training program shall provide: a current copy of the Clinical Laboratory Improvements Act of 1988 (CLIA) certification; State of Florida license verification for each clinical affiliate; and provide the names, addresses, license numbers, personnel rosters and latest licensure or certification survey reports of all affiliates that which provide clinical training for the trainees enrolled in the program. If laboratory based, provide the same information initially and at each biennial renewal.

(h)(i) No change.

(i)(j) Utilize educational resources state of the art instructional aides and methodologies for teaching the affective, cognitive, and psychomotor domains.

(k) through (l) re-designated (j) through (k) No change.

(m) In the combined categories of clinical chemistry, hematology, immunohematology, microbiology, and serology/immunology, provide a minimum of one (1) year of integrated instruction covering all categories. For any one of the single categories listed in this paragraph, a minimum of three months of instruction is required.

(n) In the category of histology, provide one (1) year of instruction.

(o) In the categories of cytogenetics, radioassay, blood gas analysis and cytology, which shall be established at the technologist level only, provide a minimum of one (1) year of instruction.

(p) In the category of andrology or embryology, a minimum of six months of instruction.

(q) In the category of molecular pathology, a minimum of six months of instruction.

(l)(r) Include instruction on Florida laws and rules governing clinical laboratories and clinical laboratory personnel. Ensure that each student receives a copy of Chapters 483, Parts I and III, and 456, F.S., and Chapters 59A-7 and 64B3, F.A.C.

(6) Clinical training programs that are not nationally accredited but were approved by the Board must submit: a curriculum outline including the numbers of lecture hours and clinical hours; national certification examination pass rates, program completion rates, and graduate placement rates and graduate employment survey results for the three (3) years prior to the submission of the renewal application.

(7)(6) No change.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 483.807, 483.809, 483.811 FS. History–New 12-28-94, Amended 7-12-95, 4-24-96, Formerly 59O-3.001, Amended 1-11-99, 11-15-99, 9-29-02, 2-2-04, 12-5-04, 2-23-06, 4-29-13, 7-20-14, 6-7-16,             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Clinical Laboratory Personnel

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Clinical Laboratory Personnel

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 2, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 18, 2017