Iowa Admin. Code r. 641-132.3

Current through Regsiter Vol. 46, No. 26, June 12, 2024

Rule 641-132.3 - Service program operations

(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.

Iowa Admin. Code r. 641-132.3

Rescinded IAB 2/9/00, effective 3/15/00.

Adopted by IAB August 12, 2020/Volume XLIII, Number 4, effective 9/16/2020