Section R9-25-503. Testing of Medical Treatments, Procedures, Med- ications, and Techniques that May Be Administered or Per- formed by an EMCT

A.      Under A.R.S. § 36-2205, the Department may authorize the testing and evaluation of a medical treatment, procedure, tech- nique, practice, medication, or piece of equipment for possible use by an EMCT or an emergency medical services provider.

B.       Before authorizing any test and evaluation according to sub- section (A), the Department director shall approve the test and evaluation according to subsections (C), (D), (E).

C.      The Department director shall consider approval of a test and evaluation conducted according to subsection (A), only if a written request for testing and evaluation:

1.        Is submitted to the Department director from:

a.         The Department,

b.        A state agency other than the Department,

c.         A political subdivision of this state,

d.        An EMCT,

e.         An emergency medical services provider,

f.         An ambulance service, or

g.        A member of the public; and

2.        Includes:

a.         A cover letter, signed and dated by the individual making the request;

b.        An identification of the person conducting the test and evaluation;

c.         An identification of the medical treatment, proce- dure, technique, practice, medication, or piece of equipment to be tested and evaluated;

d.        An explanation of the reasons for and the benefits of the test and evaluation;

e.         The scope of the test and evaluation, including the:

i.         Projected number of individuals, EMCTs, emergency medical services providers, or ambulance services involved; and

ii.        Proposed length of time required to complete the test and evaluation; and

f.         The methodology to be used to evaluate the test’s and evaluation’s findings.

D.      The Department director shall approve a test and evaluation if:

1.        The test and evaluation does not pose a threat to the pub- lic health, safety, or welfare;

2.        The test is necessary to evaluate the safest and most cur- rent advances in medical treatments, procedures, tech- niques, practices, medications, or equipment; and

3.        The medical treatment, procedure, technique, practice, medication, or piece of equipment being tested and evalu- ated may:

a.         Reduce or eliminate the use of outdated or obsolete medical treatments, procedures, techniques, prac- tices, medications, or equipment;

b.        Improve patient care; or

c.         Benefit the public’s health, safety, or welfare.

E.       Within 180 days after receiving a written request for testing and evaluation that contains all of the information in subsec- tion (C), the Department director shall send written notifica- tion of approval or denial of the test and evaluation to the individual making the request.

F.       Upon completion of a test and evaluation authorized by the Department director, the person conducting the test and evalu- ation shall submit a written report to the Department director that includes:

1.        An identification of the test and evaluation;

2.        A detailed evaluation of the test; and

3.        A recommendation regarding future use of the medical treatment, procedure, technique, practice, medication, or piece of equipment tested and evaluated.

Historical Note

Adopted effective October 15, 1996 (Supp. 96-4). Section repealed by final rulemaking at 9 A.A.R. 5372, effective January 3, 2004 (Supp. 03-4). New R9-25-503 recodified from R9-25-803 at 10 A.A.R. 4192, effective September 21, 2004 (Supp. 04-3). Amended by exempt rulemaking

at 13 A.A.R. 27, effective January 6, 2007 (Supp. 06-4). Amended by exempt rulemaking at 13 A.A.R. 578, effec- tive January 31, 2007 (Supp. 07-1). Amended by exempt

rulemaking at 14 A.A.R. 3491, effective August 14, 2008 (Supp. 08-3). Section R9-25-503 renumbered to R9-25- 505; new Section R9-25-503 renumbered from R9-25- 506 and amended by exempt rulemaking at 19 A.A.R.

4032, effective December 1, 2013 (Supp. 13-4).