R384.  Health, Disease Control and Prevention, Health Promotion.
R384-300.  Parkinson's Disease Reporting Rule.
R384-300-1.  Purpose Statement.
	(1)  The Parkinson's Disease Reporting Rule is adopted under authority of sections 26-1-30 and 26-5-3.
	(2)  Parkinson's Disease (PD) is a common neurodegenerative disease that affects one in 100 persons over the age of 65 years.  PD is a progressive, ultimately fatal condition, which may be more common in Utah than in other states.  The growth rate of the over-65 segment of the population in Utah is more than 30%.  The purpose of the Utah Parkinson's Disease Registry (Registry) is to develop a central database of accurate historical and current information for research and public health purposes.  The Parkinson's Disease Reporting Rule will provide for screening and collection of patient data that may be useful in detecting the incidence and possible risk factors concerning PD and related movement disorders.  The information gained will help increase understanding of this disease and aid in planning for early diagnosis, developing health education for patients and providers, and providing correct medical or surgical therapy health requirements.
	(3)  Parkinson's Disease records are managed by the Parkinson's Disease Registry at the University of Utah on behalf of the Utah Department of Health.  This Parkinson's Disease Reporting Rule is adopted to specify the reporting requirements for cases of Parkinson's Disease to the Registry.  The Utah Department of Health retains ownership and all rights to the records in the Registry.

R384-300-2.  Definitions.
	As used in this rule:
	(1)  "Parkinson's Disease" means a chronic, progressive disorder marked by resting tremors, muscular rigidity, and slow, imprecise movement, chiefly affecting middle-aged and elderly people.  The disease is often asymmetric.  It is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine.  Treatment with L-DOPA or dopamine agonists is virtually always helpful, although the effects may be as short as 6 months.
	(2)  "Follow-up data" includes date last seen or date of death, status of disease, date of first recurrence, type of recurrence, distant site(s) of first recurrence, and the name of the physician who is following the case.
	(3)  "Health care provider" includes any person who renders health care or professional services such as a physician, physician assistant, nurse practitioner, registered nurse, licensed practical nurse, dentist, optometrist, podiatric physician, osteopathic physician, osteopathic physician and surgeon, or others rendering patient care.
	(4)  "Registrar" means a person who
	(a)  is employed as a registrar by the Registry and has attended their training program;
	(b)  has in-depth experience with Parkinson's Disease and medical terminology relating to movement disorders; knowledge of the spectrum of providers and care settings treating PD; and knowledge of medical record discharge analysis, coding, and abstracting.

R384-300-3.  Reportable Cases.
	Each case of Parkinson's Disease or related movement disorder that is diagnosed or treated in Utah shall be reported to the Utah Parkinson's Disease Registry through a website or by mail.

R384-300-4.  Case Report Contents.
	Each report of Parkinson's Disease or related movement disorder shall include information on report forms provided by the Registry.  These reports shall be made in the format prescribed by the Registry and shall include the name and address of the patient, date of birth, gender, medical history, date and method of diagnosis, laboratory data, methods and drugs of treatment, follow-up data, physicians' names and addresses, identification of reporting source, and any additional information the Utah Department of Health demonstrates is reasonable to implement the Parkinson's Disease Registry.

R384-300-5.  Agencies or Individuals Required to Report Cases.
	(1)  All physicians, hospitals, clinics, pathology laboratories licensed to provide services in the state, nursing homes, and other facilities and health care providers involved in the diagnosis or treatment of Parkinson's Disease shall report to the Registry.
	(2)  Voluntary self-reports by patients on a confidential website developed and maintained by the University of Utah may be also included in the registry.
	(3)  Procedures for reporting:
	(a)  Hospital employed registrars shall report hospital cases.
	(b)  Individual physicians, e.g., neurologists, and clinics shall report cases seen in their practices.
	(c)  Pending implementation of electronic reporting by pathology laboratories, pathology laboratories shall allow the Registry to identify reportable cases and extract the required information during routine visits to pathology laboratories.
	(d)  If the Registry has not received complete information on a reportable case from routine reporting sources (hospitals, clinician's offices, pathology laboratories, nursing homes and other facilities), the Registry may contact health care providers and require them to complete a report form.

R384-300-6.  Time Requirements.
	(1)  New Cases:
	(a)  Providers, hospitals and clinics shall submit reports to the Registry within a year of the date of diagnosis.
	(b)  Other facilities and health care providers shall submit reportable data to the Registry upon request.
	(2)  Follow-up Data:
	(a)  Hospitals, physicians and clinics shall submit follow-up data to the Registry upon request.

R384-300-7.  Reporting Format.
	Reports shall be submitted in the standard format designated by the Registry.  Report forms can be obtained by contacting the Registry.

R384-300-8.  Data Quality Assurance.
	Records maintained by hospitals, pathology laboratories, cancer clinics, and physicians are subject to review by Registry personnel acting on behalf of the Utah Department of Health to assure the completeness and accuracy of reported data.

R384-300-9.  Confidentiality of Reports.
	All reports required by this rule are confidential under the provisions of Title 26, Chapter 3 and are not open to inspection except as allowed by Title 26, Chapter 3.  The Registry shall maintain all reports according to the provisions of Title 26, Chapter 3.

R384-300-10.  Penalties.
	Enforcement provisions and penalties for the violation or for the enforcement of public health rules, including this Parkinson's Disease Reporting Rule, are prescribed under Section 26-23-6 and are punishable.

KEY:  Parkinson's disease, reporting requirements and procedures, registry
Date of Enactment or Last Substantive Amendment:  March 12, 2015
Authorizing, and Implemented or Interpreted Law:  26-1-30; 26-5-3