Iowa Administrative Code
Agency 641 - Public Health Department
Chapter 132 - Emergency Medical Services-service Program Authorization
Rule 641-132.3 - Service Program Operations
Universal Citation: IA Admin Code 641-132.3
Current through Register Vol. 47, No. 6, September 18, 2024
(1) Ownership.
a. Each service
program will have a unique authorization number assigned by the
department.
b. A service program
with satellites will have a single authorization number assigned by the
department for all locations.
c. A
service program owner shall ensure compliance with Iowa Code chapter 147A and
these rules.
d. A service program
shall report any change in ownership to the department at least seven days
prior to the change.
e. A service
program changing ownership shall apply to the department at least seven days
prior to the change in ownership for initial authorization in accordance with
132.2(1).
(2) Medical director.
a. Each
service program shall have a designated medical director at all
times.
b. A medical director shall:
(1) Be accessible for medical direction 24
hours per day, seven days per week or ensure accessibility to alternate medical
direction.
(2) Ensure that all
duties and responsibilities of the medical director are not relinquished before
a new or temporary replacement is functioning in that capacity.
(3) Complete a department-sponsored medical
director training within one year of assuming duties as a medical director and
at a minimum once every three years thereafter.
(4) Develop, approve, and update service
program protocols that meet or exceed the minimum EMS clinical guidelines
approved by the department.
(5)
Ensure that the emergency medical care providers rostered with the service
program are credentialed in the emergency medical skills to be provided and the
duties of the emergency medical care provider do not exceed the provider's
scope of practice as referenced in 641-subrule 131.5(2) and the service
program's EMS service level of authorization.
(6) Be available for individual evaluation
and consultation with service program personnel.
(7) Have authority to restrict a service
program's authorized functional EMS service level.
(8) Have the authority to permanently or
temporarily restrict a service program member to function within a lower level
scope of practice or prohibit a service program member from providing patient
care.
(9) Approve the service
program's CQI program.
(10) Perform
or complete, or appoint a designee to perform or complete, the medical audits
in the service program's established CQI policy.
(11) Randomly audit (on at least a quarterly
basis) documentation of calls where emergency medical care was
provided.
(12) Randomly review
audits performed by the qualified appointee.
c. A medical director may:
(1) Make additions to the department-approved
EMS clinical guidelines when developing service protocols provided the
additions are within the service program's level of authorization, the EMS
provider's scope of practice, and acceptable medical practice.
(2) Request that service program providers
provide additional emergency medical care skills on a limited pilot project
basis. The pilot project applications are available on the BETS
website(www.idph.iowa.gov/BETS). The department will issue written notice of an
approved or rejected pilot project.
(3) Approve the PA and RN exception form
identifying the level of EMS provider equivalency not to exceed the service
program's EMS service level authorization for each PA and RN who will be
providing emergency medical care as part of the service program.
d. A medical director who receives
no compensation for the performance of the director's volunteer duties under
this chapter shall be considered a state volunteer as provided in Iowa Code
section
669.24 while
performing volimteer duties as an emergency medical services medical director
Compensation does not include payments for reimbursement of expenses.
e. A medical director, supervising physician,
PA, or ARNP who gives orders to an emergency medical care provider is not
subject to criminal liability by reason of having issued the orders and is not
liable for civil damages for acts or omissions relating to the issuance of the
orders unless the acts or omissions constitute recklessness.
f. Nothing in these rules requires or
obligates a medical director, supervising physician, PA, or ARNP to approve
requests for orders received from an emergency medical care provider
g. A service program medical director who
fails to comply with Iowa Code chapter 147A or these rules may be referred to
the Iowa board of medicine.
(3) Service director.
a. Each service program shall have a
designated service director at all times.
b. A service director shall:
(1) Be accessible 24 hours per day, seven
days per week or ensure accessibility to a service director designee.
(2) Be responsible for providing direction
and overall supervision of the administrative and operational aspects of the
service program.
(3) Ensure that
all duties and responsibilities of the service director are not relinquished
before a new or temporary replacement is functioning in that
capacity.
(4) Complete a
department-sponsored training within one year of assuming duties as a service
director and at a minimum once every three years thereafter
(5) Ensure the service program is in
compliance with service program policy, Iowa Code chapter 147A and these
rules.
(6) Ensure that duties of
the service program's emergency medical care providers do not exceed the
providers' scope of practice as referenced in 641-subrule 131.5(2) or the
service program's EMS service level of authorization.
(4) Service program requirements.
a. A service
program shall:
(1) Not advertise or otherwise
imply or hold itself out to the public as a service program unless currently
authorized by the department.
(2)
Only advertise at or otherwise hold itself out as having the level of full
authorization.
(3) Select a new or
temporary medical director if the current medical director cannot or no longer
wishes to serve in that capacity. Selection shall be made before the current
medical director relinquishes the duties and responsibilities of that
position.
(4) Notify the department
in writing within seven days prior to any change in medical director or any
reduction or discontinuance of operations.
(5) Select a new or temporary service
director if the current service director cannot or no longer wishes to serve in
that capacity. Selection shall be made before the current service director
relinquishes the duties and responsibilities of that position.
(6) Notify the department in writing within
seven days prior to any change in service director or any reduction or
discontinuance of operations.
(7)
Notify the department within seven days prior to any change in location of a
service program base of operations, administrative office, satellite, or
affiliate.
(8) Notify the
department within seven days when entering into agreements with one or more
service programs or a management entity to form multiservice systems for shared
service program management, administration, data submission, or other services
to ensure compliance with these rules.
(9) Report the termination or resignation in
lieu of termination of an emergency medical care provider due to negligence,
professional incompetency, unethical conduct, substance use, or violation of
any of these rules to the department in writing within ten days.
(10) Report theft of drugs to the department
in writing within 48 hours following the occurrence of the incident.
(11) Develop a notification process for
service members in the event of a motor vehicle collision involving a first
response vehicle, ambulance, rescue vehicle or personal vehicle when used by a
service program member responding as a member of the service program.
(12) Notify the department in writing within
48 hours of a motor vehicle collision resulting in personal injury or
death.
(13) Ensure a response to an
initial 911 or emergency call request to the service program, 24 hours per day,
seven days per week.
(14) Utilize
protocols developed and approved by the service program medical director that
meet or exceed the minimum EMS clinical guidelines approved by the
department.
(15) Ensure alterations
to the minimum EMS clinical guidelines by the service program's medical
director are approved by and filed with the department.
(16) Maintain a communication system at a
minimum between medical direction, receiving facility, and other emergency
responders.
(17) Maintain a current
personnel roster utilizing a department-approved registry system. Ensure all
rostered personnel are currently certified as active EMS providers in the state
of Iowa.
(18) Maintain files with
medical director and department-approved PA and RN exception forms for
appropriate personnel. PA and RN forms are available on the BETS
website(www.idph.iowa.gov/BETS).
(19)
Ensure all service program members who operate motorized emergency response
vehicles, ambulances, and rescue vehicles when used by a service member
responding as a member of the service have a valid driver's license and attend
driver training prior to driving an emergency vehicle.
(20) Develop, maintain and follow a written
driver training policy that includes a review of Iowa laws regarding emergency
vehicle operations (Iowa Code section
321.231
), frequency of service required driver training, a review of service program
policies and criteria for response with lights or sirens or both, speed limits,
procedure for approaching intersections, and use of the service program
communications equipment.
(21)
Ensure the emergency medical care provider with the highest level of
certification attends the patient unless otherwise indicated by patient
assessment and approved by the service program's protocols.
b. A transport service program shall:
(1) Provide as a minimum, on initial 911 or
emergency calls, the following staff on each primary response ambulance:
1. One currently certified emergency medical
care provider certified at the service program full level of
authorization.
2. One
driver
(2) Provide as a
minimum on each subsequent call or nonemergency call, when responding, the
following staff:
1. One currently certified
EMT.
2. One driver
(3) Establish a transport decision
policy that requires a complete assessment of a patient in order to determine
transport needs. The service transport decision policy shall include:
1. The Out-of-Hospital Trauma and Triage
Destination Decision Protocol as described in 641-Chapter 135.
2. Time critical condition considerations for
transport to facilities that specialize in conditions such as cardiac
conditions or stroke.
3. A process
for a service program provider to determine transportation to a hospital,
medical clinic, extended care facility, or other facilities where health care
is routinely provided.
4. A process
for patient refusal or nontransport if emergency transport is not warranted.
The service program provider will obtain a signed transport/treatment refusal
document or liability release if transport is not required.
5. A process by which a service program
provider may make arrangements for alternate transport if emergency transport
is not needed and remain with the patient until alternate transport arrives
unless the provider is called to respond to another emergency.
c. Nontransport service
programs.
(1) Nontransporting service
programs, when responding to 911 or emergency calls, shall provide as a minimum
one currently certified emergency medical care provider certified at the
service program full level of authorization.
(2) Nontransport service programs shall have
an executed written transport agreement ensuring simultaneous dispatch with an
authorized transport service program for all 911 or emergency calls.
(3) Nontransport service programs may
transport patients in an ambulance only in an emergency situation when lack of
transporting resources would cause an unnecessary delay in patient
care.
(5) Data reporting.
a. "The Iowa
Emergency Medical Services Data Dictionary" (September 2019) is incorporated by
reference for data to be reported to the EMS data registry. For any differences
which may occur between the adopted reference and the rules in this chapter,
the rules shall prevail.
b. "The
Iowa Emergency Medical Services Data Dictionary" is available through the Iowa
Department of Public Health, Bureau of Emergency and Trauma Services, Lucas
State Office Building, Des Moines, Iowa 50319-0075, or the BETS
website(www.idph.iowa.gov/BETS).
c. A
service program shall report data electronically to the department.
d. A service program shall submit data in a
format approved by the department.
e. A service program shall submit reportable
data to the department no later than the last day of the month following the
month services were provided.
f. The
department shall prepare compilations for release or dissemination on
reportable data entered into the EMS data registry during the reporting period.
The compilations shall include, but not be limited to, trends and clinical
outcomes for local, regional and statewide evaluations. The compilations shall
be made available to all providers submitting reportable patient data to the
registry.
g. The data collected by
the EMS data registry and furnished to the department pursuant to this rule are
confidential records of the condition, diagnosis, care, or treatment of
patients or former patients including outpatients, pursuant to Iowa Code
section
22.7. The
compilations prepared for release or dissemination from the data collected are
not confidential under Iowa Code section
22.7(2).
However, information which individually identifies patients shall not be
disclosed, and state and federal law regarding patient confidentiality shall
apply.
h. The department may
approve requests for reportable patient data for special studies and analysis
provided:
(1) The request has been reviewed
and approved by the department with respect to the scientific merit and
confidentiality safeguards.
(2) The
department has given administrative approval for the proposal.
(3) The confidentiality of patients and
service programs is protected pursuant to Iowa Code section
22.7 and chapter
147A.
(4) The department may
require those requesting the data to pay any or all of the reasonable costs
associated with furnishing the reportable data.
i. For the purpose of ensuring the
completeness and quality of reportable data, the department or authorized
representative may examine all or part of the data record as necessary to
verify or clarify all reportable data submitted by a service program.
j. To the extent possible,
activities under this subrule shall be coordinated with other health data
collection methods.
k. A service
program will develop, maintain and follow a written data submission
policy.
(6) Patient care reporting.
a.
Each service program, satellite, and affiliate shall complete and maintain a
patient care report documenting the care provided to each patient.
b. The patient care report is a confidential
document and shall be exempt from disclosure pursuant to Iowa Code section
22.7(2)
and shall not be accessible to the general
public. Information contained in these reports, however, may be utilized by any
of the indicated distribution recipients and may appear in any document or
public health record in a manner which prevents the identification of any
patient or person named in these reports.
c. To facilitate the continuum of care,
transport service programs shall provide at a minimum, upon delivery of a
patient to a receiving facility, a verbal patient care report that contains
details of the assessment and care provided.
d Transport service programs shall provide a
final patient care report within 24 hours to the receiving facility. Transport
services and receiving facilities must work together to initiate reasonable and
realistic mechanisms (including but not limited to paper, secure email, secure
links, secure electronic system retrieval, and access to printers at the
receiving facility) to ensure the delivery of the patient care
report.
e. A service program will
develop, maintain, and follow a written patient care report policy.
(7) Continuous quality improvement (CQI).
a. A service
program shall develop, maintain, and follow a CQI program that follows a
written CQI policy.
b. The CQI
program shall include medical audits that review patient care
provided.
c. The CQI program shall
be utilized to identify deficiencies or potential deficiencies regarding
medical knowledge or skill or procedure performance.
d. The CQI program shall review at a minimum
911 response and scene times.
e.
The CQI program shall develop a written plan that monitors, identifies and
documents at a minimum continuing education, credentialing of skills and
procedures, and personnel performance for the service program's emergency
medical care providers, drivers, PA and RN exceptions.
f. The CQI program shall establish measurable
outcomes that reflect the goals and standards of the service program.
g. The CQI program shall ensure completion of
loop closure/resolution of identified areas of concern.
(8) Medications in service programs.
a. A service program shall
have written pharmacy agreements in accordance with the Iowa board of
pharmacy's 657-Chapter II.
b. A
service program shall maintain all medications in accordance with the rules of
the Iowa board of pharmacy's 657-Chapters 10 and II.
c. A service program shall develop, maintain,
and follow a written pharmacy policy.
(9) Vehicle standards, supplies, equipment and maintenance.
a.
Effective January I, 2022, all service programs, regardless of their
designation as govemmentally owned, not-for-profit, or privately operated,
shall annually systematically inspect, repair, and maintain, or cause to be
systematically inspected, repaired, and maintained, all ambulances operated by
the service program.
b. A service
program shall utilize a vehicle inspection report approved by the department to
record the results of an annual ambulance safety inspection. Annual safety
inspection forms which comply with the requirements of 49 CFR 396 shall be
approved by the department. A sample annual vehicle inspection form which
complies with the reporting requirements of 49 CFR 396 can be formed on the
BETS website(www.idph.iowa.gov/BETS/EMS).
c. A
service program shall ensure individuals performing annual safety inspections
are qualified and capable of performing an inspection by reason of experience,
training, or both.
d. A service
program shall not use an ambulance that fails to meet or maintain the
requirements of this subrule to transport patients.
e. A service program shall house primary
response ambulances in a garage or other enclosed facility that is maintained
in a clean, safe condition, free of debris or other hazards; is temperature
controlled; and has an imobstructed exit to the street.
f. A service program shall secure all
equipment stored in the ambulance patient compartment so the patient and
service program personnel are not injured by moving equipment.
g. Effective January 1, 2022, new ambulances
manufactured and placed into service shall meet at a minimum either the
Commission on Accreditation of Ambulance Services (CAAS) Ground Vehicle
Standard for Ambulances or the National Fire Protection Association (NFPA)
Standard for Automotive Ambulances (NFPA 1917).
h. A service program shall maintain first
response and rescue vehicles in safe operating condition and provide regular
maintenance. Vehicles shall have the exterior clean and the interior clean and
disinfected.
i. A service program
shall ensure medical and patient care supplies are monitored for expiration
dates, cleaned, laundered or disinfected. All medical supplies shall be stored
in clean environments.
j. A service
program shall ensure personal protection equipment and supplies are available
to ensure emergency medical care responder safety during every
response.
k. A service program
shall ensure supplies to properly dispose of biomedical hazardous waste are
available in all response vehicles, and all waste shall be disposed of
according to accepted biomedical waste practices.
l. A service program shall ensure medical
equipment is maintained per manufacturer requirements for safe emergency
medical care provider and patient use.
m. A service program shall develop, maintain,
and follow vehicle standards, supplies, and equipment maintenance
policies.
Disclaimer: These regulations may not be the most recent version. Iowa may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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