Mississippi Administrative Code › Title 15 - Mississippi Department of Health › Part 8 - Office of Health Policy and Planning › Subpart 90 - Planning and Resource Development › Chapter 05 - Acute Care Facilities and Services Overview › Section 15-8-90-05-513 - Certificate of Need Criteria and Standards for Diagnostic and Therapeutic Imaging Services › Section 15-8-90-05-513.02 - Positron Emission Tomography (PET) Equipment and Services › Section 15-8-90-05-513.02.03 - Certificate of Need Criteria and Standards for Offering of Fixed or Mobile Positron Emission Tomography (PET) Services including Cardiac only PET Scanner

Current through June 25, 2024
The offering of fixed or mobile PET services is
						  reviewable if the proposed provider has not provided those services on a
						  regular basis within the period of twelve (12) months prior to the time such
						  services would be offered.
Need Criterion 1
:
Minimum
						  Procedures
The entity desiring to offer PET services must document
						  that the equipment shall perform a minimum of 1,000 clinical procedures per
						  year and must show the methodology used for the projection.
Need Criterion 2
:
PET Equipment
						  Utilized by Multiple Providers
It is recognized that a particular PET unit may be
						  utilized by more than one provider of PET services, some of which may be
						  located outside of Mississippi. In such cases all existing or proposed
						  providers of PET services utilizing the same PET unit must jointly meet the
						  required service volume of 1,000 procedures annually. If the PET unit in
						  question is presently utilized by other providers of PET services, the actual
						  number of procedures performed by them during the most recent 12-month period
						  may be used.
Need Criterion 3
:
Quality Control
						  and Environmental Requirements
An applicant proposing to provide new or expanded PET
						  services must include written assurances in the application that the service
						  will be offered in a physical environment that conforms to federal standards,
						  manufacturer's specifications, and licensing agencies' requirements. The
						  following areas are to be addressed:
a. Quality control and assurance of
						radiopharmaceutical production of generator or cyclotron-produced
						agents;
b. Quality control and
						assurance of PET tomograph and associated instrumentation;
c. Radiation protection and shielding;
						and
d. Radioactive emissions to the
						environment.
Need Criterion 4
:
Division of
						  Radiological Health Approval
The application shall affirm that the applicant shall
						  receive approval from the Division of Radiological Health for the proposed
						  site, plans, and equipment before service begins.
Need Criterion 5
:
Provision of
						  On-Site Medical Cyclotron
The applicant shall document provision of an on-site
						  medical cyclotron for radionuclide production and a chemistry unit for labeling
						  radiopharmaceuticals; or an on-site rubidium-82 generator; or access to a
						  supply of cyclotron-produced radiopharmaceuticals from an off-site medical
						  cyclotron and a radiopharmaceutical production facility within a two-hour air
						  transport radius.
Need Criterion 6
:
Staffing
						  Requirements
Applicants for PET shall document that the necessary
						  qualified staff are available to operate the proposed unit. The applicant shall
						  document the PET training and experience of the staff. The following minimum
						  staff shall be available to the PET unit:
a. If operating a fixed PET unit, one or more
						nuclear medicine imaging physician(s) available to the PET unit on a full-time
						basis (e.g., radiologist, nuclear cardiologist) who have been licensed by the
						state for the handling of medical radionuclides and whose primary
						responsibility for at least a one-year period prior to submission of the CON
						application has been in acquisition and interpretation of tomographic images.
						This individual shall have knowledge of PET through training, experience, or
						documented postgraduate education. The individual shall also have training with
						a functional PET facility.
b. If
						operating a cyclotron on site, a qualified PET radiochemist or radiopharmacist
						personnel, available to the facility during PET service hours, with at least
						one year of training and experience in the synthesis of short-lived positron
						emitting radiopharmaceuticals. The individual(s) shall have experience in the
						testing of chemical, radiochemical, and radionuclidic purity of PET
						radiopharmaceutical syntheses.
c.
						Qualified engineering and physics personnel, available to the facility during
						PET service hours, with training and experience in the operation and
						maintenance of the PET equipment. Engineering personnel are not required
						on-site for mobile PET units.
d.
						Qualified radiation safety personnel, available to the facility at all times,
						with training and experience in the handling of short-lived positron emitting
						nuclides. If a medical cyclotron is operated on-site, personnel with expertise
						in radiopharmacy, radiochemistry, and medical physics would also be
						required.
e. Certified nuclear
						medicine technologists with expertise in computed tomographic nuclear medicine
						imaging procedures, at a staff level consistent with the proposed center's
						expected PET service volume.
f.
						Other appropriate personnel shall be available during PET service hours which
						may include certified nuclear medicine technologists, computer programmers,
						nurses, and radio-chemistry technicians.
Need Criterion 7
:
Management of
						  Medical Emergencies
The applicant shall demonstrate how medical emergencies
						  within the PET unit will be managed in conformity with accepted medical
						  practice.
Need Criterion 8
:
Accommodating
						  Referred Patients
The applicant shall affirm that, in addition to
						  accepting patients from participating institutions, facilities performing
						  clinical PET procedures shall accept appropriate referrals from other local
						  providers. These patients shall be accommodated to the extent possible by
						  extending the hours of service and by prioritizing patients according to
						  standards of need and appropriateness rather than source of referral.
Need Criterion 9
:
Medical
						  Necessity
The applicant shall affirm that protocols will be
						  established to assure that all clinical PET procedures performed are medically
						  necessary and cannot be performed as well by other, less expensive, established
						  modalities.
Need Criterion 10
:
No
t
ification of Procedures Offered
Applicants will be required to maintain current
						  listings of appropriate PET procedures for use by referring physicians.
Need Criterion 11
:
Data
						  Requirements
The applicant shall provide assurances that the
						  following data regarding the PET service will be kept and made available to
						  MSDH upon request:
a. Total number of
						procedures performed; total number of inpatient procedures (indicate type of
						procedure);
b. Total number of
						outpatient procedures (indicate type of procedure);
c. Average charge per specific
						procedure;
d. Hours of operation of
						the PET unit;
e. Days of operation
						per year; and
f. Total revenue and
						expense for the PET unit for the year.
Need Criterion 12
:
CON
						  Approval/Exemption for PET Equipment
Before the specified service can be provided, the
						  applicant desiring to offer the PET service shall provide written evidence that
						  the specified PET equipment provider has CON approval or written evidence that
						  the equipment is exempt from CON approval as determined by MSDH through a
						  determination of reviewability. Each specified piece of equipment must be
						  exempt from or have CON approval.