To clarify that the variations on the term “site survey” in statute and rule have the same meaning.

 

DEPARTMENT OF HEALTH

Division of Emergency Preparedness and Community Support

RULE NO.:RULE TITLE:

64J-2.001Definitions

PURPOSE AND EFFECT: To clarify that the variations on the term “site survey” in statute and rule have the same meaning. 

SUMMARY: The term “site survey” is not defined in statute or in rule. Seven variations on the term appear in statute and in rule: “onsite visit” in section 395.4025(6), (11), (12), F.S.; “site survey” in section 395.4025(15)(d), F.S. and in Rules 64J-2.012(3), 64J-2.015(2), (3), 64J-2.016(9)(c)-(e), F.A.C.; “site review” in section  395.4025(15)(d), F.S.; “site visit” in Rules 64J-2.011(2)(b), (4)(b), 64J-2.012(1) (Table), (k), (l), 64J-2.016(3), (7), (8), F.A.C.; “on-site survey” in Rules 64J-2.015(2), 64J-2.016(3), F.A.C.; “on-site evaluation” in Rule 64J-2.016(1), (2), F.A.C.; and “onsite review” in Rule 64J-2.016(5)(b), F.A.C. In each instance, the variation on the term “site survey” describes the same inspection and observation that the Department is authorized to conduct to verify that a trauma center is compliant with the standards adopted by the Department by rule, irrespective of the method by which the inspection and observation is conducted; i.e., in-person and onsite, remote and offsite, or a combination thereof. The proposed change will clarify that the terms “onsite visit,” “site survey,” “site review,” “site visit,” “on-site survey,” “on-site evaluation,” and “onsite review” all describe the in-person or remote inspection and observation of trauma center operations to determine compliance with trauma center standards.

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: Through its analysis of regulatory costs required as a part of the SERC analysis, the Department has determined this rule will not require legislative ratification pursuant to Section 120.541(3), F.S.

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: 395.4025(7), (10), (14), 395.405 FS.

LAW IMPLEMENTED: 381.0011, 381.0205, 395.3025(4)(f), 395.40(3)-(6), 395.401, 395.4015, 395.402, 395.4025, 395.4045, 395.405 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: Michael Leffler, Trauma Section Manager at [e-mail] or by phone at [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64J-2.001 Definitions.

In addition to the definitions provided in Sections 395.401, 395.4001, 401.107, and 401.23, F.S., the following definitions apply to rules under Chapter 64J-2, F.A.C.:

(1) through (6) No change.

(7) Onsite visit, site survey, site review, site visit, on-site survey, on-site evaluation, and onsite review – means an in-person or Department-approved remote audio-visual inspection and observation of the resources and processes for providing trauma patient treatment and care, together with in-person or Department-approved remote inspection and review of original and electronic health records and documentation of the quality of trauma patient treatment, care, and trauma patient outcomes.

(7) through (15) renumbered as (8) through (16) No change.

(17) This rule shall be reviewed, and if necessary, repealed or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 395.4001(13), (17), 395.401(1), (2), 395.4025(7), (9), (10), (14), 395.4036(1), 395.4045(3), (4), (5), (8), 395.405 FS. Law Implemented 381.0205, 395.1031, 395.3025(4)(f), 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.4036, 395.404, 395.4045, 395.405 FS. History–New 11-5-09, Amended 3-4-20,            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kate Kocevar, Trauma Section Administrator

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott Rivkees, MD, Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 31, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR:  October 1, 2020