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The IAC Standards
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1.1A Medical
Director(s) must be a licensed physician and be an authorized user of
radioisotopes according to NRC or state regulatory agency regulations. If the
facility performs nuclear medicine therapies, the Medical Director also must be
an authorized user for these procedures.
1.1.1A Medical
Director Required Training and Experience
The Medical Director must meet at least one of the following criteria:
1.1.1.1A Board
certified (or Board eligible but within two years of finishing training) in cardiology
and completion of a minimum of a four-month formal training program
in nuclear cardiology [Level 2 as outlined in the ACC/ASNC
COCATS Training Guidelines (2006 revision)]. This requirement applies only to
cardiologists who began their cardiology training in July 1995 or later.
1.1.1.2A Board certified in cardiology and training equivalent to
Level 2 training or at least one year (full-time equivalent) of nuclear
cardiology practice experience with independent interpretation of at least 800
nuclear cardiology studies. This requirement applies only to cardiologists who
began their cardiology training before July 1995.
1.1.1.3A Certification
in nuclear cardiology by the Certification Board of Nuclear Cardiology (CBNC).
1.1.1.4A Board
certified (or Board eligible but within two years of finishing training) in
nuclear medicine.
1.1.1.5A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology with
at least four months of nuclear cardiology training.
1.1.1.6A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology with
special competence in nuclear medicine.
1.1.1.7A Board certified
(or Board eligible but within two years of finishing training) in diagnostic radiology and
at least one year (full-time equivalent) of nuclear cardiology practice
experience with independent interpretation of at least 800 nuclear cardiology
studies.
1.1.1.8A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology with
at least four months of nuclear medicine training with interpretation of at
least 800 nuclear medicine procedures.
1.1.1.9A Board certified (or Board eligible but within two years
of finishing training) in any other relevant medical specialty recognized by
the American Board of Medical Specialties (ABMS), American Osteopathic
Association (AOA), Royal College of Physicians and Surgeons of Canada or Le College
des Medicins du Quebec and at least one year (full-time equivalent) of nuclear
cardiology/nuclear medicine/PET practice experience with independent
interpretation of at least 800 nuclear cardiology/nuclear medicine and/or PET
procedures. If performing nuclear medicine therapies, independent performance
of a least 20 nuclear medicine therapies required.
1.1.1.10A If
training before 1995, 10 years of nuclear cardiology, nuclear medicine and/or
PET practice with independent interpretation of at least 800 nuclear cardiology,
nuclear medicine and/or PET studies within the past 10 years of which 200 cases
must have been interpreted in the past two years.
1.1.2A Medical
Director Responsibilities
1.1.2.1A Responsible
for all nuclear medicine services provided including quality control (QC),
radiation safety, quality of care and appropriateness of care.
These responsibilities include but are not limited to:
i. The
Medical Director will assure compliance with all policies/procedures/ protocols
and will review and update clinical/radiation
safety manuals periodically as necessary (minimum every year) or as new
policies are introduced. This review must be documented via signature (or
initials) and date on the reviewed document or manual.
Comment:
The Medical Director must delegate, in writing, the review of
policies/procedures/protocols to an appropriate designee, for areas in which
the Medical Director does not have the education/training/experience. The
designee must be a physician who meets the criteria outlined in 1.1.1A that is
relevant to the delegated responsibility.
ii. Active oversight of radiation safety within the facility
as evidenced by membership on the institution’s radiation safety
committee or periodic review of radiation safety issues and documentation (if
no radiation safety committee). The Radiation Protection Program content and
compliance must be reviewed at least annually.
Comment: The Medical Director may delegate,
in writing, the supervision of compliance with radiation safety standards to
the Technical Director, Radiation Safety Officer or health physics consultant.
iii. The Medical Director must be a member of the facility and provide the
final interpretation/report of some nuclear medicine procedures for the
facility.
Comment: The Medical
Director may supervise the entire operation of the facility or delegate, in
writing, specific operations but is responsible for assuring compliance of
medical and technical staff to the Standards outlined in this document. Where
the Medical Director is not the radiation safety officer, the Medical
Director’s responsibility regarding radiation safety is to assure
compliance with the facility’s radiation protection program, as
implemented by the radiation safety officer.
1.1.3A Continuing
Medical Education (CME) Requirements
1.1.3.1A The
Medical Director must obtain at least 15 hours of AMA Category I CME credits,
relevant to nuclear medicine, every three years.
Comment: “Relevant” to nuclear medicine includes content
that is directly related to the performance or interpretation of nuclear
cardiology, general
nuclear medicine, PET or interventions used during nuclear testing (such
as stress testing) or content that is directly related to one of the IAC
Nuclear/PET Standards. This
may include no more than five credits of MR and/or CT CME. This does not
include education primarily concerning echocardiography/ultrasound, cardiac catheterization,
general medicine or the treatment of diseases unless directly related to the
interpretation of nuclear imaging or radionuclide therapies.
Comment: If the Medical Director has successfully
attained ONE or more of the following within the three years prior to the
application submission date, the CME requirement will be considered fulfilled:
completion of an Accreditation Council for Graduate Medical Education (ACGME)
approved relevant residency or fellowship; attaining initial certification by a
relevant ABMS recognized board; attaining initial certification by the CBNC; or
re-certification by the American Board of Nuclear Medicine (ABNM), American
Board of Radiology (ABR) or CBNC.
1.1.3.2A Documentation
of CME credits must be kept on file and available for inspection.
1.1.3.3A A maximum of five of the 15 required
credits may come from MR and/or CT education or Certification Board of
Cardiovascular Computed Tomography (CBCCT) certification/recertification.
(See Guidelines below for further recommendations.)
1.2A A
qualified Technical Director(s) is designated for the facility. The designated
Technical Director must be a nuclear medicine technologist with the following
qualifications:
1.2.1A Technical
Director Required Training and Experience
The Technical Director must meet the following criteria:
1.2.1.1A All
Technical Directors must possess an appropriate credential in nuclear medicine
technology [Certified Nuclear Medicine Technologist (CNMT, NCT or PET) or
Registered Technologist (Nuclear) RT(N) credential in the U.S. or Registered
Technologist Nuclear Medicine (RTNM) or Medical Radiation Technologist
(Nuclear) MRT(N) credential in Canada]. However, if the Technical Director was
appointed prior to January 1, 2010, a state license to practice as a nuclear
medicine technologist is also acceptable.
1.2.1.2A Current
Basic Life Support (BLS) certification.
1.2.2A Technical
Director Responsibilities
The Technical Director has a reporting relationship with the Medical Director.
Responsibilities must include, but are not limited to:
1.2.2.1A the
day-to-day operations of the facility;
Comment: The Technical Director is generally a full-time position. If the Technical
Director is not on-site full time, he/she must work a minimum of at least 20%
of normal business hours each month in the facility AND an appropriately
credentialed technologist must be appointed in the Technical Director’s
physical absence during normal business hours and report to the Technical
Director.
i. The
appointed technologist acting as Technical Director:
· may
supervise and assist others in performing examinations;
· may
oversee day-to-day activities;
· must
communicate at least weekly with the Technical Director to maintain compliance
with the IAC Nuclear/PET Standards.
1.2.2.2A the
written delegation, as necessary, of specific responsibilities to the technical
and/or ancillary staff;
1.2.2.3A verification
and documentation of proper training and, at least annually, assessment of
competence of technical staff and/or any ancillary staff who report to the
Technical Director.
1.2.3A Continuing
Education (CE) Requirements
1.2.3.1A The
Technical Director must obtain at least 15 hours of accredited CE relevant to
nuclear medicine, every three years. All CE hours must be approved CE (i.e.,
VOICE, ASRT, ACE, AMA Category I).
Comment: “Relevant” to nuclear medicine includes content that is
directly related to the performance or interpretation of nuclear cardiology, general nuclear medicine, PET
or interventions used during nuclear testing (such as stress testing) or
content that is directly related to one of the IAC Nuclear/PET Standards. This may include no more than
five credits of MR and/or CT CME. This does not include education primarily
concerning echocardiography/ultrasound, cardiac catheterization, general
medicine or the treatment of diseases unless directly related to the
interpretation of nuclear imaging or radionuclide therapies.
Comment: If the Technical Director has successfully attained ONE of the
following within the three years prior to the application submission date, the
CE requirement will be considered fulfilled: completion of an accredited
nuclear medicine training program; attainment of an appropriate technical credential
in nuclear medicine; or attainment of advanced technical credential (NCT, PET or Nuclear Medicine
Advanced Associate [NMAA]).
1.2.3.2A Documentation
of CE credits must be kept on file and available for inspection.
1.2.3.3A A maximum of five of the 15 required credits
may come from MR and/or CT education or attainment of an advanced technical
credential in MR and/or CT.
(See Guidelines below for further recommendations.)
1.3A All
members of the medical staff must be licensed physicians. Any physician
authorizing administration of radiopharmaceuticals must be an authorized user
of radioisotopes according to NRC or state regulatory agency regulations.
1.3.1A Medical
Staff Required Training and Experience
The interpreting medical staff member(s) must meet at least one of the
following criteria:
1.3.1.1A Board
certified (or Board eligible but within two years of finishing training) in
cardiology and completion of a minimum of a four-month formal training program in
nuclear cardiology [Level 2 as outlined in the ACC/ASNC COCATS Training
Guidelines (2006 revision)]. This requirement applies only to cardiologists who
began their cardiology training in July 1995 or later.
1.3.1.2A Board
certified in cardiology and training equivalent to Level 2 training or at least
one year (full-time equivalent) of nuclear cardiology practice experience with
independent interpretation of at least 800 nuclear cardiology studies. This
requirement applies only to cardiologists who began their cardiology training
before July 1995.
1.3.1.3A Certification
in nuclear cardiology by the Certification Board of Nuclear Cardiology (CBNC).
1.3.1.4A Board
certified (or Board eligible but within two years of finishing training) in
nuclear medicine.
1.3.1.5A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology with
at least four months of nuclear cardiology training.
1.3.1.6A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology with
special competence in nuclear medicine.
1.3.1.7A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology and
at least one year (full-time equivalent) of nuclear cardiology practice
experience with independent interpretation of at least 800 nuclear cardiology
studies.
1.3.1.8A Board
certified (or Board eligible but within two years of finishing training) in diagnostic radiology with
at least four months of nuclear medicine training with interpretation of at
least 800 nuclear medicine procedures.
1.3.1.9A Board
certified (or Board eligible but within two years of finishing training) in any
other relevant medical specialty recognized by the American Board of Medical
Specialties, American Osteopathic Association, Royal College of Physicians and
Surgeons of Canada or Le College des Medicins du Quebec and at least one year
(full-time equivalent) of nuclear cardiology/nuclear medicine/PET practice
experience with independent interpretation of at least 800 nuclear
cardiology/nuclear medicine and/or PET procedures. If performing nuclear
medicine therapies, independent performance of a least 20 nuclear medicine
therapies required.
1.3.1.10A If
training before 1995, 10 years of nuclear cardiology, nuclear medicine and/or
PET practice with independent interpretation of at least 800 nuclear
cardiology, nuclear medicine and/or PET studies within the past 10 years of
which 200 cases must have been interpreted in the past two years.
1.3.2A Interpreting
Medical Staff Responsibilities
Medical staff responsibilities include but are not limited to:
1.3.2.1A The
interpreting medical staff must provide the final interpretation/report of the
nuclear medicine procedures.
1.3.3A Continuing
Medical Education (CME) Requirements
1.3.3.1A The
interpreting medical staff members must obtain at least 15 hours of AMA Category
1 CME credits, relevant to nuclear medicine, every three years.
Comment: “Relevant” to nuclear medicine includes content that is
directly related to the performance or interpretation of nuclear cardiology, general nuclear medicine, PET
or interventions used during nuclear testing (such as stress testing) or
content that is directly related to one of the IAC Nuclear/PET Standards. This may include no more than five credits of MR and/or
CT CME. This does not include education primarily concerning echocardiography/ultrasound,
cardiac catheterization, general medicine or the treatment of diseases unless directly
related to the interpretation of nuclear imaging or radionuclide therapies.
Comment: If the medical staff member has successfully attained ONE or more of
the following within the three years prior to the application submission date,
the CME requirement will be considered fulfilled: completion of an ACGME
approved relevant residency or fellowship, attaining initial certification by a
relevant ABMS recognized board, attaining initial certification by the CBNC or
re-certification by the American Board of Nuclear Medicine, American Board of
Radiology or CBNC.
1.3.3.2A Documentation
of CME credits must be kept on file and available for inspection.
1.3.3.3A A maximum of five of the 15 required
credits may come from MR and/or CT education or Certification Board of
Cardiovascular Computed Tomography (CBCCT) certification/recertification.
(See Guidelines below for further recommendations.)
1.4A All technical staff must be
nuclear medicine technologists who have the following qualifications:
1.4.1A Technical Staff Required
Training and Experience
The technical staff must meet the following criteria:
1.4.1.1A An appropriate
credential in nuclear medicine technology (i.e., certification [Certified Nuclear
Medicine Technologist (CNMT, NCT or PET) or Registered Technologist (Nuclear)
RT(N) credential in the U.S. or Registered Technologist Nuclear Medicine (RTNM)
or Medical Radiation Technologist (Nuclear) MRT(N) credential in Canada] and/or
state license to practice as a nuclear medicine technologist).
1.4.1.2A Current
Basic Life Support (BLS) certification.
1.4.2A Technical Staff
Responsibilities
Technical staff responsibilities
include but are not limited to:
1.4.2.1A The technical staff must
report to the Technical Director. The technical staff are responsible for image
acquisition and the performance of procedures and other duties, as assigned.
1.4.3A Continuing
Education (CE) Requirements
1.4.3.1A The technical staff must
obtain at least 15 hours of accredited CE relevant to nuclear medicine, every
three years. All CE hours must be approved CE (i.e., VOICE, ASRT, ACE, AMA
Category I).
Comment: “Relevant” to nuclear medicine includes content that is directly
related to the performance or interpretation of nuclear cardiology, general nuclear medicine, PET,
or interventions used during nuclear testing (such as stress testing) or
content that is directly related to one of the IAC Nuclear/PET Standards. This may include no more than
five credits of MR and/or CT CE. This does not include education
primarily concerning echocardiography/ultrasound, cardiac catheterization,
general medicine or the treatment of diseases unless directly related to the
interpretation of nuclear imaging or radionuclide therapies.
Comment: If the technical staff member has successfully attained ONE of the
following within the three years prior to the application submission date, the
CE requirement will be considered fulfilled: completion of an accredited
nuclear medicine training program, attainment of an appropriate technical
credential in nuclear medicine or attainment of advanced technical credential (NCT, PET or Nuclear Medicine
Advanced Associate [NMAA]).
1.4.3.2A Documentation
of CE credits must be kept on file and available for inspection.
1.4.3.3A A maximum of five of the 15 required
credits may come from MR and/or CT education or attainment of an advanced
technical credential in MR and/or CT.
(See Guidelines below for further recommendations.)
1.5A All
direct patient care personnel must meet the following qualifications:
1.5.1A All
personnel directly supervising stress procedures must have appropriate
training/experience. While physician presence during stress testing is not
required, the facility must assure that appropriate staff is present based upon
the types of procedures being performed and the patients’ risks of
adverse events.
1.5.1.1A If a non-physician
practitioner (e.g., properly trained nurse, physician assistant, nurse practitioner,
exercise physiologist, physical therapist) practicing under the physician’s license is
supervising the stress test, the facility or Medical Director must document
appropriate training and competence as outlined in the American College of Cardiology/American Heart Association Clinical
Competence Statement on Stress Testing and the AHA Scientific Statement:
Supervision of Exercise Testing by Nonphysicians (See Bibliography).
Comment: See Appendix A for specific training and competence
requirements.
1.5.1.2A If a non-physician practitioner is supervising the
stress test, a physician must be in the immediate vicinity on the premises and
available for emergencies.5
1.5.2A A
minimum of two qualified people are required to be in attendance at the time of
radionuclide injection during stress testing (e.g., person supervising the
stress test and person authorized to inject the radionuclide). It is preferable
that two people be in attendance during the entire stress test.
1.5.3A Basic
Life Support – There must be BLS-certified personnel on-site and immediately available during cardiac stress procedures.
(See Guidelines below for further recommendations.)
1.5.4A Advanced
Cardiac Life Support (ACLS) – Any
provider (e.g., physician and non-physician providers) directly
supervising stress procedures must have appropriate training/experience
and must be certified in ACLS.
1.5.5A Stress
Testing Oversight – There must be a system in place for the assurance of
the proper administration, including timing, of radiopharmaceuticals relative
to the performance of stress testing. If the personnel who conduct stress
testing for nuclear imaging procedures are not under the supervision of the
Medical Director (e.g., if the stress testing is done by staff in or from
another department), there must be a policy in place that assures the proper
administration of radiopharmaceuticals (especially timing).
(See Guidelines below for further recommendations.)
1.6A Physicians
and nuclear medicine technologists in training must not compromise patient
care.
1.6.1A Physician
and Nuclear Medicine Technologist Trainee Supervision
1.6.1.1A All
trainees must be under the overall supervision of the Medical Director or
Technical Director, as appropriate, who determines and outlines all
responsibilities. The day-to-day supervision can be carried out by a medical or
nuclear medicine technologist staff member. Qualified nuclear medicine
technologists and physicians must supervise all clinical procedures and record
keeping. The Medical Director or a medical staff member must provide the final
interpretation of all studies.
(See Guidelines
below for further recommendations.)
1.7A All
personnel who assist nuclear medicine technologists with direct patient care
must have documented training, experience and competency consistent with their
duties. These duties must be acceptable under local, state and federal
law/regulations.
1.7.1A If the
nuclear medicine assistant is performing duties that are typically performed
only by a certified/licensed nuclear medicine technologist (such as
radiopharmaceutical preparation or administration, patient positioning, image
acquisition or processing), there must be a certified/licensed nuclear medicine
technologist identified, in writing, as the assistant’s supervising
technologist. The supervising technologist is responsible for the
assistant’s actions.
1.7.2A There
must be a certified/licensed nuclear medicine technologist immediately
available in the facility during nuclear medicine patient care (may be the
individual assistant’s supervising technologist or another
certified/licensed nuclear medicine technologist to whom this oversight
responsibility has been delegated).
1.7.3A A
nuclear medicine assistant must not perform therapeutic nuclear medicine procedures.
(See Guidelines below for further recommendations.)
1.8A Ancillary
personnel necessary for safe and effective patient care must be available.
1.8.1A Ancillary
personnel staffing must be appropriate for the level of service such that
direct care personnel can devote appropriate attention to delivering effective
care and patient safety is not compromised. The specific needs of a facility
must be determined by evaluation of the types and volumes of procedures as well
as facility configuration.
1.8.1.1A Ancillary
personnel may consist of:
i. clerical
and administrative assistants;
ii. physicist
or consulting physicist;
iii. radiopharmacist;
iv. computer
support staff; and/or
v. other
support personnel.
i. All
ancillary personnel within the department must be supervised by the Medical
Director or a qualified designee.
ii. The
supervisor must document/verify proper training, at least annually and current
competence of the ancillary personnel appropriate to the assigned duties.
(See Guidelines below for further recommendations.)
1.1A, 1.2A, 1.3A, 1.4A, 1.5A, 1.6A, 1.7A and 1.8A -
Duties and responsibilities: The
facility should have written
descriptions of the duties and responsibilities, not outlined in the Standards,
for each staff position
1.3A All
members of the medical staff are encouraged to be authorized users of
radioisotopes for the type(s) of procedure(s) they will be
interpreting/performing.
1.5.3A Basic Life Support – All
personnel involved in direct patient care during all nuclear medicine and PET
procedures should be certified in basic life support.