To amend those rules identified as not being authorized by statute. These revisions will bring Chapter 64J-1, F.A.C. into compliance with the provisions of Chapter 120.536, F.S. Amending paragraphs 64J-1.004(2)(b), (3)(c), (d), F.A.C.

DEPARTMENT OF HEALTH
Division of Emergency Medical Operations

Rule No.: RULE TITLE
64J-1.004: Medical Direction
PURPOSE AND EFFECT: To amend those rules identified as not being authorized by statute. These revisions will bring Chapter 64J-1, F.A.C. into compliance with the provisions of Chapter 120.536, F.S. Amending paragraphs 64J-1.004(2)(b), (3)(c), (d), F.A.C.
SUBJECT AREA TO BE ADDRESSED: Medical Director qualifications and responsibilities.
SPECIFIC AUTHORITY: 381.0011, 395.405, 401.265, 401.272, 401.35, 499.05 FS.
LAW IMPLEMENTED: 401.23, 401.24, 401.25, 401.26, 401.265, 401.27, 401.281, 401.2915, 401.30, 401.34, 401.35, 401.41, 401.411, 499.005 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
TIME AND DATE: Thursday, December 9, 2010, 1:00 p.m. – 3:00 p.m.
PLACE: Florida Department of Health, Bureau of Emergency Medical Service, Capital Circle Office Complex, 4025 Esplanade Way, 3rd Floor, Room 301, Tallahassee, Florida 32311, [phone], extension *2773. A conference call line will be available to those participants not able to attend the workshop. The conference number is: [phone], conference code: 1454440.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 24 hours before the workshop/meeting by contacting: Melia Jenkins at [phone], ext. 2773. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Melia Jenkins at [phone], ext. 2773

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

64J-1.004 Medical Direction.

(1) Each ALS, BLS or air ambulance provider shall maintain on file for inspection and copying by the department its current contract for a medical director by which it employs or independently contracts with a physician qualified pursuant to this section to be its medical director.

(2) There is no standard format for a medical director’s contract, however, in drafting such an instrument, the following provisions may be addressed:

(a) Name and relationship of the contracting parties.

(b) A list of contracted services inclusive of medical direction, administrative responsibilities, professional membership, basic and advanced life support review responsibilities, and reporting requirements.

(c) Monetary consideration inclusive of fees, expenses, reimbursement, fringe benefits, clerical assistance and office space.

(d) Termination clause.

(e) Renewal clause.

(f) Provision for liability coverage.

(g) Effective dates of the contract.

(3) Qualifications:

(a) A medical director shall be a Florida licensed M.D. or D.O.

(b) In addition to all other provisions applicable to medical directors in this rule, an air ambulance medical director shall be knowledgeable of the aeromedical requirements of patients and shall evaluate each patient in person or by written protocol prior to each interfacility transfer flight for the purpose of determining that the aircraft, flight and medical crew, and equipment meet the patient’s needs.

(c) A medical director shall be board certified and active in a broad-based clinical medical specialty with demonstrated experience in prehospital care and hold an ACLS certificate or equivalent as determined in Rule 64J-1.022, F.A.C. Prehospital care experience shall be documented by the provider.

(c)(d) A medical director shall demonstrate and have available for review by the department documentation of active participation in a regional or statewide physician group involved in prehospital care.

(4) Duties and Responsibilities of the Medical Director.

(a) Develop medically correct standing orders or protocols which permit specified ALS and BLS procedures when communication cannot be established with a supervising physician or when any delay in patient care would potentially threaten the life or health of the patient. The medical director shall issue standing orders and protocols to the provider to ensure that the provider transports each of its patients to facilities that offer a type and level of care appropriate to the patient’s medical condition if available within the service region. The medical director or his appointee shall provide continuous 24-hour-per-day, 7-day-per-week medical direction which shall include in addition to the development of protocols and standing orders, direction to personnel of the provider as to availability of medical direction “off-line” service to resolve problems, system conflicts, and provide services in an emergency as that term is defined by Section 252.34(3), F.S.

(b) Develop and implement a patient care quality assurance system to assess the medical performance of paramedics and EMTs. The medical director shall audit the performance of system personnel by use of a quality assurance program to include but not be limited to a prompt review of patient care records, direct observation, and comparison of performance standards for drugs, equipment, system protocols and procedures. The medical director shall be responsible for participating in quality assurance programs developed by the department.

(c) With the exception of BLS medical directors each ALS or air ambulance service medical director shall possess proof of current registration as a medical director, either individually or through a hospital, with the U.S. Department of Justice, DEA, to provide controlled substances to an EMS provider. DEA registration shall include each address at which controlled substances are stored. Proof of such registration shall be maintained on file with each ALS or air ambulance provider and shall be readily available for inspection.

(d) Ensure and certify that security procedures of the EMS provider for medications, fluids and controlled substances are in compliance with Chapters 499 and 893, F.S., and Chapter 64F-12, F.A.C.

(e) Create, authorize and ensure adherence to, detailed written operating procedures regarding all aspects of the handling of medications, fluids and controlled substances by the provider.

(f) Notify the department in writing of each substitution by the EMS provider of equipment or medication.

(g) Assume direct responsibility for: the use of an automatic or semi-automatic defibrillator; the use of a glucometer; the administration of asprin; the use of any medicated auto injector; the performance of airway patency techniques including airway adjuncts, not to include endotracheal intubation; and on routine interfacility transports, the monitoring and maintenance of non-medicated I.V.s by an EMT. The medical director shall ensure that the EMT is trained to perform these procedures; shall establish written protocols for the performance of these procedures; and shall provide written evidence to the department documenting compliance with provisions of this paragraph.

(h) An EMT employed by a licensed ALS provider is authorized to start a non-medicated IV under the following conditions:

1. A non-medicated IV is initiated only in accordance with department approved protocols of the licensed ALS provider’s medical director. These protocols must include a requirement that the non-medicated IV be initiated in the presence of a Florida certified paramedic (of the same licensed provider) who directs the EMT to initiate the IV.

2. If the licensed ALS provider elects to utilize EMTs in this capacity, the licensed EMS provider shall ensure that the medical director provides training at least equivalent to that required by the 1999 U.S. D.O.T. EMT-Intermediate National Standard Curriculum relating to IV therapy which is incorporated by reference and available from the Superintendent of Documents, Post Office Box 371954, Pittsburgh, PA 15250-7954. The licensed EMS provider shall document successful completion of such training in each EMTs training file and make documentation available to the department upon request.

(i) Ensure that all EMTs and paramedics are trained in the use of the trauma scorecard methodologies as provided in Rule 64J-2.004, F.A.C., for adult trauma patients and Rule 64J-2.005, F.A.C., for pediatric trauma patients.

(j) Develop and revise when necessary TTPs for submission to the department for approval.

(k) Participate in direct contact time with EMS field level providers for a minimum of 10 hours per year. Notwithstanding the number of EMS providers served by the medical director, direct contact time shall be a minimum of 10 hours per year per medical director, not per provider.

(l) Medical Directors of a training program shall:

1. Be responsible for the instruction of the Department of Transportation (DOT) approved training program for EMTs and paramedics.

2. Have substantial knowledge of the qualifications, training, protocols, and quality assurance programs for the training facility.

3. Maintain current instructor level training in Advanced Cardiac Life Support (ACLS), or equivalent, or Advanced Trauma Life Support (ATLS), maintain provider or instructor level training in International Trauma Life Support (ITLS), Prehospital Trauma Life Support (PHTLS), or Advanced Trauma Life Support (ATLS); and Advanced Pediatric Life Support (APLS), Pediatric Advanced Life Support (PALS), Pediatric Education for Prehospital Professionals (PEPP), or Emergency Pediatric Care (EPC).

4. Act as a liaison between training centers, local EMS providers and hospitals.

5. Participate in state and local quality assurance and data collections programs.

6. The EMS training center shall by contract, require such medical director to be available 4 hours per month for classroom teaching or review of student performance, and participate in direct contact time with EMS field level providers for a minimum of 10 hours per year. Notwithstanding the number of training centers or EMS providers served by the medical director, direct contact time shall be a minimum of 10 hours per year per medical director, not per training center.

7. The training program shall provide written documentation to the Department that confirms the Medical Director has reviewed and approved all policies, procedures, and methods used for the orientation of instructors and preceptors.

8. The training program shall provide written documentation to the Department that confirms the Medical Director has reviewed and approved all student testing procedures, evaluators and assessment tools used for each comprehensive final written (cognitive) and practical examination (psychomotor skills) for EMT and paramedic students. The Medical Director shall review each student’s performance on the comprehensive final written (cognitive) and practical examination (psychomotor skills) before certifying a student has successfully completed all phase of the educational program and EMTs are proficient in basic life support techniques and paramedics are proficient in advanced life support techniques.

(5) The medical director of a licensed EMS provider may authorize paramedics under his or her supervision to perform immunizations pursuant to a written agreement with a County Health Department in the county in which the immunizations are to be performed. Should the medical director elect to utilize paramedics in this capacity, he or she shall verify on DH Form 1256, Certification of Training, December 2008, which is incorporated by reference and available from the department, that each paramedic authorized to administer immunizations has completed training consistent with that of other staff giving immunizations in the County Health Department as required by the Director of that County Health Department.

Rulemaking Authority 381.0011, 395.405, 401.265, 401.272, 401.35, 499.05 FS. Law Implemented 401.23, 401.24, 401.25, 401.26, 401.265, 401.27, 401.281, 401.2915, 401.30, 401.34, 401.35, 401.41, 401.411, 499.005 FS. History–New 8-7-89, Amended 6-6-90, 12-10-92, 1-26-97, Formerly 10D-66.0505, Amended 8-4-98, 1-3-99, 2-20-00, 4-15-01, 11-19-01, 10-24-05, 12-18-06, Formerly 64E-2.004, Amended 5-27-10,________.