Notice of Proposed Rule

DEPARTMENT OF HEALTH
Board of Clinical Laboratory Personnel
RULE NO: RULE TITLE
64B3-3.001: General Requirements of Clinical Laboratory Personnel Training Programs
PURPOSE AND EFFECT: The purpose of this amendment is to incorporate: (1) a new form to be utilized by applicants seeking approval to be clinical laboratory personnel training programs; (2) a new form for the self study document required of clinical laboratory personnel training programs; and (3) a new form for reporting a trainee’s status change.
SUMMARY: Rule 64B3-3.001, F.A.C., sets forth the requirements imposed on Clinical Laboratory Personnel Training Programs.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Costs was prepared. The Board determined the proposed rule will not have an impact on small business.
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: 483.805(4), 483.811(2) FS.
LAW IMPLEMENTED: 483.800, 483.809, 483.811 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe Baker, Jr., 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 be approved by the Board of Clinical Laboratory Personnel and pay the fee set forth in subsection 64B3-9.001(3)(8), F.A.C. An applicant for approval shall apply to the Department on Form # DH-MQA 3007 (11/08) “Training Program Instructions” which is incorporated by reference herein, copies of which can be obtained from the Board office at 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257 or from its website at http://www.doh.state.fl.us/mqa/ClinLab/index.html.

(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 shall be submitted to the Department on Form #DH-MQA 1167 (11/08) “Clinical Laboratory Training Program Self Study Document for Programs not Nationally Accredited” which is incorporated by reference herein, copies of which can be obtained from the Board office at 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257 or from its website at http://www.doh.state.fl.us/mqa/ClinLab/index.html 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 may be substituted in lieu of the self study document.

(b) No change.

(4) All trainee’s names shall be reported to the Board upon acceptance into the clinical laboratory personnel training program and at the time of the program’s biennial renewal. The program director shall also report to notify the Board when a trainee withdraws. These reports shall be submitted to the Board on Form # DH-MQA 1166 (revised 11/08) “Notice of Trainee Status Change” which is incorporated by reference herein, copies of which can be obtained from the Board office at 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257 or from its website at http://www.doh.state.fl.us/mqa/ClinLab/index.html.

(5) through (6) No change.

Rulemaking Specific Authority 483.805(4), 483.811(2) FS. Law Implemented 483.800, 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, ________.


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: November 14, 2008
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 27, 2009