DAR File No. 42285

This rule was published in the November 15, 2017, issue (Vol. 2017, No. 22) of the Utah State Bulletin.

Health, Disease Control and Prevention, Epidemiology

Rule R386-702

Communicable Disease Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 42285
Filed: 11/01/2017 02:43:35 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to incorporate information in accordance with the 2017 Council of State and Territorial Epidemiologists (CSTE) position statement recommendations, clarify reporting requirements, and clarify language in an effort to improve interpretation of rule requirements.

Summary of the rule or change:

Reportable condition changes: 1) added Bacillus cereus infections caused by strains that express anthrax toxin genes (pXO1 and/or pXO2 plasmids), including B. cereus biovar anthracis. This was added to the anthrax case definition by CSTE in 2017. These infections are rare, but will cause an anthrax-like illness, and should be treated like an anthrax infection; 2) added Candida auris or Candida haemulonii from any body site. These are emerging diseases causing concern for both multidrug resistance and healthcare transmission; 3) added Chagas disease. There is evidence that the vector for this disease may be present in Utah, which makes addition of this disease important as a potential emerging infection; 4) added Middle-East Respiratory Syndrome (MERS); 5) added a section mandating antimicrobial susceptibility testing when performed on 1 of 12 different organisms; 6) clarified that syphilitic stillbirths are reportable as syphilis cases; 7) clarified acute, chronic, and perinatal hepatitis C are all reportable; 8) specified encephalitis due to any organism (bacterial, fungal, parasitic, protozoan, and viral) is reportable; 9) removed aseptic meningitis; and 10) removed Staphyloccus aureus with vancomycin-intermediate resistance (VISA). Reportable through electronic laboratory reporting changes: 1) added positive influenza tests; 2) added Pseudomonas aeruginosa, resistant to a carbapenem, or with demonstrated carbapenemase production; and 3) added methicillin-susceptible Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA) from normally sterile sites. Mandatory submission of clinical material changes: 1) added Candida auris or Candida haemulonii from any body site; 2) added carbapenem resistant Acinetobacter species, Enterobacter species, Escherichia coli, Klebsiella species, and Pseudomonas aeruginosa; and 3) removed vancomycin intermediate Staphylococcus aureus. Additional changes are: 1) mandated electronic laboratory reporting from laboratories. Electronic Laboratory Reporting (ELR) is the electronic transmission of data from the laboratories to the public health of laboratory reports which identify reportable conditions; 2) incorporated by reference reporting specification documents; 3) authorized electronic case reporting as an acceptable reporting method; 4) updated the Special Measures for the Control of HIV/AIDS. Specifically, revised definitions and added a definition for re-engagement to care; 5) added language specifying that entities ordering a laboratory test for a reportable communicable disease must provide the performing laboratory with the patient�s address so that the laboratory can report to the appropriate jurisdiction; 6) corrected references throughout the rule; and 7) updated reference information in the "Official References" section.

Statutory or constitutional authorization for this rule:

Title 26, Chapter 23b
Section 26-1-30
Section 26-6-3

This rule or change incorporates by reference the following material:

Updates Red Book, published by American Academy of Pediatrics, 05/01/2015

Anticipated cost or savings to:

the state budget:

Please see Appendix: Regulatory Impact Analysis for Small and Non-Small Businesses. It is anticipated that proposed changes will require programming and mapping of data fields equating to approximately 0.10 FTE over 4 months to make modifications in diseases being added, removed, or changed. While some conditions are being added to the list, it is important to note that these conditions are anticipated to be rare (one case per year would be unusual), and because they are emerging conditions, they were formerly reportable as such. Therefore, making the conditions explicit will aid in clarifying for reporters that they are reportable, but will not result in costs. However, removal of two conditions from the reportable diseases list will result in decreased time required for epidemiologists to enter and analyze data (approximately 11 hours per year), manage case information, and proposed implementation of electronic laboratory reporting is anticipated to accrue further savings due to decreased time needed for data entry (estimated to save approximately 574 hours at state level). Overall, this results in anticipated savings at the state level. In addition, anticipated benefits from proposed changes at the state level include: better characterization of disease burden at the state level; increased data accuracy and quality, improved timeliness of reporting resulting in improved timeliness in case referral to local health departments for investigation and management of cases allowing for more rapid identification of, and response to, outbreaks.

local governments:

Please see Appendix: Regulatory Impact Analysis for Small and Non-Small Businesses. Because proposed changes require programming time at the state level, and for laboratories, no costs are anticipated for local health departments. However, savings are anticipated for local health departments related to the decreased time needed to investigate and manage cases for conditions being removed (approximately 90 hours per year). Further savings are anticipated related to electronic laboratory reporting. It is anticipated that approximately 844 hours of data entry time will be saved per local health department, or nearly 11,000 hours for all 13 local health departments in Utah, with full implementation of electronic laboratory reporting in Utah. In addition, anticipated benefits from proposed changes at the local level include: better characterization of disease burden at the local level; increased data accuracy and quality; improved timeliness of reporting resulting in improved timeliness in receipt, investigation, and management of cases allowing for more rapid intervention, as well as identification of, and response to, outbreaks.

small businesses:

No Utah laboratories that will be required to report electronically are small businesses.

persons other than small businesses, businesses, or local governmental entities:

Please see Appendix: Regulatory Impact Analysis for Small and Non-Small Businesses. There are 54 laboratories in Utah that are required to report conditions to public health, all of which are non-small businesses. Currently, 49/54 (91%) are in the process of implementing electronic reporting. During the first year, it is estimated that the remaining five laboratories will incur a one-time annual cost of $15,000 (approximately $5,000 to build an interface, and $10,000 for programming costs). All laboratories will then have an ongoing annual cost of approximately $1,500 for maintenance of their respective reporting system. Additionally, to make programming changes associated with the proposed changes to the reportable conditions list, it is estimated that approximately 8 hours of programming time per laboratory (1 hour per condition added, removed, or modified) will be needed, or approximately $600 per laboratory. Looking at anticipated savings, overall, there should be a net benefit from these changes for these laboratories. In 2016, 54,000 reports were provided to public health through non-electronic means; estimating 10 minutes per case for laboratory technicians to identify, fax, email, or call information to local or state public health, implementation of electronic reporting will result in approximately 9,180 hours of reporting time saved annually, or approximately 170 hours per laboratory. In addition, it is known that electronic reporting results in more complete notification to public health as it replaces a manual process that may result in delayed, incomplete, or forgotten reports. As an example, after transitioning one laboratory in Utah to electronic reporting, the number of cases of Campylobacter reported from this laboratory increased by 45%, and the number of cases of Chlamydia reported from this laboratory increased by 27%. Also, public health in Utah receives notifications of reportable conditions faster from laboratories that report electronically. On average, Utah public health is notified of a reportable condition within three days after identification from electronic reporters, vs. six days after identification from non-electronic reporters because reporting is required within three days of identification of cases. This change will result in better compliance with reporting requirements in the rule. Other persons: Please see Appendix: Regulatory Impact Analysis for Small and Non-Small Businesses. Because there are two Tribes in Utah who use Utah's communicable disease surveillance system, EpiTrax, for surveillance and management of reportable conditions, it is anticipated that they will benefit from implementation of universal electronic laboratory reporting in the same way that local health departments will (i.e., from data entry savings of approximately 844 hours a year each, as well as benefits associated with more timely identification, investigation, and management of cases). Further, the proposed changes will lead to benefits for all citizens of the State of Utah, since it will result in more rapid identification and response to cases and outbreaks, which results in more rapid control and mitigation, and less exposure to infectious diseases and the resulting impacts of diseases in the community.

Compliance costs for affected persons:

Comments by the department head on the fiscal impact the rule may have on businesses:

The proposed amendment fiscally impacts businesses through the need for programming changes. The benefits to the rapid identification and response to cases and outbreaks will result in more rapid control and mitigation of the impact of infectious diseases on Utah citizens that live in an affected community.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Epidemiology
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

Melissa Stevens Dimond at the above address, by phone at 801-538-6810, by FAX at 801-538-9923, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/15/2017

This rule may become effective on:

12/22/2017

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

Appendix: Regulatory Impact Analysis for Small and Non-Small Businesses

	FY 2018	FY 2019	FY 2020
Fiscal Costs
State Government	$2,550	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$181,575	$81,000	$81,000
Other Persons	$0	$0	$0
Total Fiscal Costs:	$184,125	$81,000	$81,000

Fiscal Benefits
State Government	$9,953	$9,953	$9,953
Local Government	$191,828	$191,828	$191,828
Small Businesses	$0	$0	$0
Non-Small Businesses	$297,248	$297,248	$297,248
Other Persons	$28,918	$28,918	$28,918
Total Fiscal Benefits:	$527,947	$527,947	$527,947

Net Fiscal Benefits:	$343,822	$446,947	$446,947

Note: Proposed changes in the rule that will incur direct costs include: 1) the proposal to make electronic laboratory reporting mandatory in Utah; and 2) the proposal to modify conditions that are reported in Utah, which would primarily require some programming time by laboratories. There are 54 laboratories in Utah, all of whom are non-small businesses. Please see the cost information in the rule anaylsis above for details regarding cost and benefit estimates for proposed amendments to this rule.

R386. Health, Disease Control and Prevention, Epidemiology.

R386-702. Communicable Disease Rule.

R386-702-1. Purpose Statement.

(1) The Communicable Disease Rule is adopted under authority of Sections 26-1-30, 26-6-3, and 26-23b.

(2) This rule outlines a multidisciplinary approach to communicable and infectious disease control and emphasizes reporting, surveillance, isolation, treatment and epidemiological investigation to identify and control preventable causes of infectious diseases. Reporting requirements and authorizations are specified for communicable and infectious diseases, outbreaks, and unusual occurrence of any disease. Each section has been adopted with the intent of reducing disease morbidity and mortality through the rapid implementation of established practices and procedures.

(3) The successes of medicine and public health dramatically reduced the risk of epidemics and early loss of life due to infectious agents during the twentieth century. However, the emergence of diseases such as Middle Eastern Respiratory Syndrome (MERS), and the rapid spread of diseases such as West Nile virus to the United States from other parts of the world, made possible by advances in transportation, trade, food production, and other factors, highlight the continuing threat to health from infectious diseases. Continual attention to these threats and cooperation among all health care providers, government agencies, and other entities that are partners in protecting the public's health are crucial to maintain and improve the health of the citizens of Utah.

R386-702-2. Definitions.

(1) Terms in this rule defined in Section 26-6-2:

(a) Carrier

(b) Communicable disease

(d) Epidemic

(e) Infection

(f) Schools

(2) Terms in this rule defined in Section 26-6-6:

(a) Health care provider

(3) Terms in this rule defined in Section 26-21-2:

(a) Assisted living facilities

(b) Nursing care facilities

(4) Terms in this rule defined in Section 26-23b-102:

(a) Bioterrorism

(5) Terms in this rule defined in Section 26-39-102:

(a) Childcare programs

(6) Terms in this rule defined in Section 78B-3-403:

(a) Health care facilities

(7) Terms in this rule defined in Section 62A-15-602:

(a) Mental health facilities

(8) Terms in this rule defined in Section R386-80-2:

(a) Local health department

(9) In addition, for purposes of this rule:

(a) "Blood and plasma center" is defined as a blood bank, blood storage facility, plasma center, hospital, any another facility where blood or blood products are collected, or any facility where blood services are provided.

(b) "Care facilities licensed through the Department of Human Services" is described as any facility licensed through the Utah Department of Human Services, and includes adult day care facilities, adult foster care facilities, crisis respite facilities, domestic violence shelters and treatment programs, foster care homes, mental health treatment programs, residential treatment and day treatment facilities for persons with disabilities, substance abuse treatment programs, and youth treatment programs.

(c) "Case" is defined as any person, living or deceased, identified as having a communicable disease, condition, or syndrome that meets criteria for being reportable under this rule, or that is otherwise under public health investigation.

(d) "Clinic" is defined as any facility where a health care provider practices.

(e) "Condition" is defined as an abnormal state of health that may interfere with a person's regular feelings of wellbeing.

(f) "Correctional facility" is defined as an facility that forcibly confines an individual under the authority of the government, including but not limited to prisons, detention centers, jails, juvenile detention centers.

(g) "Department" is defined as the Utah Department of Health.

(h) "Diagnostic facility" is defined as the facility where the case or suspect case was seen and evaluated by a healthcare provider.

(i) "Dispensary" is defined as an office in a school, hospital, industrial plant, or other organization that dispenses medications or medical supplies.

(j) "Electronic case reporting" is defined as the transmission of clinical, diagnostic, laboratory, and treatment related data from reporting entities to the Department in a structured, computer-readable format that reflects comparable content to HL7 CDA(reg trademark) R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR). Electronic Initial Case Reporting is a form of electronic reporting.

(k) "Electronic laboratory reporting" is defined as the transmission of laboratory or health related data from reporting entities to the Department using HL7 ORU-R01 2.3.1 or 2.5.1, LOINC, and SNOMED standard message structure and vocabulary. Electronic laboratory reporting is a form of electronic reporting.

(l) "Electronic reporting" is defined as the transmission of laboratory or health related data from reporting entities to the Department in a structured, computer-readable format that reflects comparable content to HL7 messaging.[~~using standard message structure and vocabulary, and do not require any hand keying for data to be incorporated into Department databases.~~]

( m[k]) "Encounter" is defined as an instance of an individual presenting to a health care facility.

( n[l]) "Event" is defined as any communicable disease, condition, laboratory result, syndrome, outbreak, epidemic, or other public health hazard that meets criteria for being reportable under this rule.

( o[m]) "Good Samaritan" is defined as a person who gives reasonable aid to strangers in grave physical distress.

( p[n]) "Invasive disease" is defined as infection occurring in parts of the body where organisms are not normally present, such as the bloodstream, organs, or the meninges.

( q[o]) "Laboratory" is defined as any facility that receives, refers, or analyzes clinical specimens.

( r[p]) "Manual reporting" is defined as the transmission of laboratory or health related data from reporting entities to the Department using processes that require hand keying for data to be incorporated into Department databases.

( s[q]) "Normally sterile site" is defined as a part of the body where organisms are not normally present, such as the bloodstream, organs, or the meninges.

( t[r]) "Outbreak" is defined as the increased occurrence of any communicable disease, health condition, or syndrome in a community, institution, or region; or two or more cases of a communicable disease, health condition, or syndrome in persons with a common exposure.

( u[s]) "Public health hazard" is defined as the presence of an infectious organism or condition in the environment which endangers the health of a specified population.

( v[t]) "Suspect case" is defined as any person, living or deceased, who a reporting entity, local health department, or the Department believes might be a case, but for whom it has not been established that the criteria necessary to become a case have been met.

( w[u]) "Syndrome" is defined as a set of signs or symptoms that often occur together.

R386-702-3. Reportable Events.

(1) The Department declares the following events to be of concern to public health and reporting of all instances is required or authorized by Sections 26-6-6 and 26-23b.

(2) Events Reportable by All Entities.

(a) Acute flaccid myelitis;

(b) Adverse event resulting from smallpox vaccination (Vaccinia virus, Orthopox virus);

(d) Anthrax (Bacillus anthracis) or anthrax-like illness caused by Bacillus cereus strains that express anthrax toxin genes;

(e) Antibiotic resistant organisms from any clinical specimen that meet the following criteria:

(i) Resistant to a carbapenem, or with demonstrated carbapenemase, in:

(A) Acinetobacter species,

(B) Enterobacter species,

(D) Klebsiella species,

(ii) Resistant [~~or intermediate resistant~~ ]to vancomycin in:

(A) Staphylococcus aureus ([~~VISA/~~]VRSA);

(f) Arbovirus infection, including but not limited to:

(i) Chikungunya virus infection,

(ii) West Nile virus infection, and

(iii) Zika virus infection, including congenital;

(g) Babesiosis (Babesia spp.);

(h) Botulism (Clostridium botulinum);

(i) Brucellosis (Brucella spp.);

(j) Campylobacteriosis (Campylobacter spp.);

(k) Candida auris or Candida haemulonii from any body site;

(l) Chagas disease;

( m[k]) Chancroid (Haemophilus ducreyi);

( n[l]) Chickenpox (Varicella zoster virus, VZV, Human herpesvirus 3, HHV-3);

( o[m]) Chlamydia (Chlamydia trachomatis);

( p[n]) Coccidioidomycosis (Coccidioides spp.), also known as valley fever;

( q[o]) Colorado tick fever (Colorado tick fever virus, Coltivirus spp.), also known as American mountain tick fever;

( r[p]) Cryptosporidiosis (Cryptosporidium spp.);

( s[q]) Cyclosporiasis (Cyclospora spp., including Cyclospora cayetanensis);

( t[r]) Dengue fever (Dengue virus);

( u[s]) Diphtheria (Corynebacterium diphtheriae);

( v[t]) Ehrlichiosis (Ehrlichia spp.);

( w[u]) Encephalitis (bacterial, fungal, parasitic, protozoan, and viral);

( x[v]) Shiga toxin-producing Escherichia coli (STEC) infection;

( y[w]) Giardiasis (Giardia lamblia), also known as beaver fever;

( z[x]) Gonorrhea (Neisseria gonorrhoeae), including sexually transmitted and ophthalmia neonatorum;

( aa[y]) Haemophilus influenzae, invasive disease;

( bb[z]) Hantavirus infection (Sin Nombre virus);

( cc[aa]) Hemolytic uremic syndrome, postdiarrheal;

( dd[bb]) Hepatitis, viral, including but not limited to:

(i) Hepatitis A,

(ii) Hepatitis B (acute, chronic, and perinatal),

(iii) Hepatitis C (acute, chronic, and perinatal),

(iv) Hepatitis D, and

(v) Hepatitis E;

( ee[cc]) Human immunodeficiency virus (HIV) infection, including acquired immune deficiency syndrome (AIDS) diagnosis;

( ff[dd]) Influenza virus infection:

(i) Associated with a hospitalization,

(ii) Associated with a death in a person under 18 years of age, or

(iii) Suspected or confirmed to be caused by a non-seasonal influenza strain;

( gg[ee]) Legionellosis (Legionella spp.), also known as Legionnaires' disease;

( hh[ff]) Leptospirosis (Leptospira spp.);

( ii[gg]) Listeriosis (Listeria spp., including Listeria monocytogenes);

( jj[hh]) Lyme disease (Borrelia burgdorferi);

( kk[ii]) Malaria (Plasmodium spp.);

( ll[jj]) Measles (Measles virus), also known as rubeola;

( mm[kk]) Meningitis (aseptic, bacterial, fungal, parasitic, protozoan, and viral);

( nn[ll]) Meningococcal disease (Neisseria meningitidis), invasive;

(oo) Middle East Respiratory Syndrome (MERS);

( pp[mm]) Mumps (Mumps virus);

( qq[nn]) Mycobacterial infections, including:

(i) Tuberculosis (Mycobacterium tuberculosis complex),

(ii) Leprosy (Mycobacterium leprae), also known as Hansen's Disease,

(iii) All other mycobacterial infections (Mycobacterium spp.);

( rr[oo]) Pertussis (Bordetella pertussis);

( ss[pp]) Plague (Yersinia pestis);

( tt[qq]) Poliomyelitis (Poliovirus), paralytic and nonparalytic;

( uu[rr]) Psittacosis (Chlamydophila psittaci), also known as ornithosis;

( vv[ss]) Q fever (Coxiella burnetii);

( ww[tt]) Rabies (Rabies virus), human and animal;

( xx[uu]) Relapsing fever (Borrelia spp.), tick-borne and louse-borne;

( yy[vv]) Rubella (Rubella virus), including congenital syndrome;

( zz[ww]) Salmonellosis (Salmonella spp.);

( aaa[xx]) Severe acute respiratory syndrome, also known as SARS (SARS coronavirus or SARS-CoV);

( bbb[yy]) Shigellosis (Shigella spp.);

( ccc[zz]) Smallpox (Variola major and Variola minor);

( ddd[~~aaa~~]) Spotted fever rickettsioses (Rickettsia spp.), including Rocky Mountain spotted fever (Rickettsia rickettsii);

( eee[~~bbb~~]) Streptococcal disease, invasive, due to:

(i) Streptococcus pneumoniae,

(ii) Group A Streptococcus (Streptococcus pyogenes), and

(iii) Group B Streptococcus (Streptococcus agalactiae);

( fff[~~ccc~~]) Syphilis (Treponema pallidum), including:

(i) all stages,

(ii) [~~and~~ ]congenital, and

(iii) syphilitic stillbirths;

( ggg[~~ddd~~]) Tetanus (Clostridium tetani);

( hhh[~~eee~~]) Toxic shock syndrome, staphylococcal (Staphylococcus aureus) or streptococcal (Streptococcus pyogenes);

( iii[~~fff~~]) Transmissible spongiform encephalopathies (prion diseases), including Creutzfeldt-Jakob disease;

( jjj[~~ggg~~]) Trichinellosis (Trichinella spp.);

( kkk[~~hhh~~]) Tularemia (Francisella tularensis);

( lll[~~iii~~]) Typhoid (Salmonella typhi), cases and carriers;

( mmm[~~jjj~~]) Vibriosis (Vibrio spp.), including Cholera (Vibrio cholerae);

( nnn[~~kkk~~]) Viral hemorrhagic fevers, including but not limited to:

(i) Ebola fever (Ebolavirus spp.),

(ii) Lassa fever (Lassa virus), and

(iii) Marburg fever (Marburg virus);

( ooo[~~lll~~]) Yellow fever (Yellow fever virus).

(3) Perinatally Transmissible Conditions Reportable by All Entities.

(a) Pregnancy is a reportable event for the following communicable diseases, and reporting is required even if the communicable disease was reported to public health prior to the pregnancy:

(i) Hepatitis B infection;

(ii) Hepatitis C infection;

(iii) HIV infection;

(iv) Listeriosis;

(v) Rubella;

(vi) Syphilis infection; and

(vii) Zika virus infection.

(4) Antibiotic Susceptibility Tests Reportable by All Entities.

(a) Full panel antibiotic susceptibility test results, including minimum inhibitory concentration and results suppressed to the ordering clinician, are reportable when performed on the following organisms:

(i) Candida auris/Candida haemulonii from any body site;

(ii) Mycobacterium tuberculosis;

(iii) Neisseria gonorrhoeae;

(iv) Salmonella species;

(v) Shigella species; and

(vi) Streptococcus pneumoniae.

(vii) Organisms resistant to a carbapenem, or with demonstrated carbapenemase, in:

(A) Acinetobacter species,

(B) Enterobacter species,

(D) Klebsiella species;

(viii) Organisms resistant to vancomycin in:

(A) Staphylococcus aureus (VRSA);

(b) All individual carbapenemase test results (positive, negative, equivocal, indeterminate), including the method used, are reportable when performed on the following organisms:

(i) Resistant to a carbapenem, or with demonstrated carbapenemase, in:

(A) Acinetobacter species,

(B) Enterobacter species,

(D) Klebsiella species.

(b) Antiviral susceptibility test results; including nucleotide sequencing, genotyping, or phenotypic analysis ; are reportable when performed on the following organisms:

(i) Human immunodeficiency virus (HIV).

([4]5) Unusual Events Reportable by All Entities.

(a) Unusual events include one or more cases or suspect cases of a communicable disease, condition, or syndrome considered:

(i) Rare, unusual, or new to Utah;

(ii) Previously controlled or eradicated;

(iii) Caused by an unidentified or newly identified organism;

(iv) Exposure or infection that may indicate a bioterrorism event with potential transmission to the public; or

(v) Any other infection not explicitly identified in Subsection R386-702-3(2) that public health considers a public health hazard.

([5]6) Outbreaks, Epidemics, or Unusual Occurrences of Events Reportable by All Entities.

(a) Entities shall report two or more cases or suspect cases, with or without an identified organism, including but not limited to:

(i) Gastrointestinal illnesses;

(ii) Respiratory illnesses;

(iii) Meningitis or encephalitis;

(iv) Infections caused by antimicrobial resistant organisms;

(v) Illnesses with suspected foodborne or waterborne transmission;

(vi) Illnesses with suspected ongoing transmission in any facility;

(vii) Infections that may indicate a bioterrorism event; or

(viii) Any other infections not explicitly identified in Subsection R386-702-3(2) that public health considers a public health hazard.

(b) Entities shall report increases or shifts in pharmaceutical sales that may indicate changes in disease trends; or

([6]7) Laboratory Results Reportable by Electronic Reporters.

(a) In addition to laboratory results set forth in Subsection s R386-702-3(2) through R386-702-3(6), [~~the Department declares the following laboratory results to be reportable by entities reporting electronically.~~

~~(b) E~~]entities reporting electronically shall include the following laboratory results or laboratory results that provide presumptive evidence of the following communicable diseases:

(i) Influenza virus;

(ii) Norovirus infection;

(iii) Pseudomonas aeruginosa, resistant to a carbapenem, or with demonstrated carbapenemase production;

(iv) Staphylococcus aureus from a normally sterile site with methicillin testing performed, reported as either methicillin-susceptible Staphylococcus aureus (MSSA) or methicillin-resistant Staphylococcus aureus (MRSA); and

([ii]v) Streptococcal disease, invasive due to all species.

([c]b) Entities reporting electronically shall include all laboratory results (positive, negative, equivocal, indeterminate) associated with the following tests or conditions:

(i) CD4+ T-Lymphocyte tests, regardless of known HIV status;

(ii) Chlamydia;

(iii) Clostridium difficile;

(iv) Cytomegalovirus (CMV), congenital (infants less than or equal to 12 months of age);

(v) Gonorrhea;

(vi) Hepatitis A;

(vii) Hepatitis B , including viral loads;

(viii) Hepatitis C, including viral loads;

(ix) HIV, including viral loads and confirmatory tests;

(x) Liver function tests, including ALT, AST, and bilirubin associated with a viral hepatitis case;

(xi) Lyme disease;

(xii) Syphilis;

(xiii) Tuberculosis; and

(xiv) Zika virus.

(c) Entities reporting electronically shall report full panel antibiotic susceptibility test results, including minimum inhibitory concentration and results suppressed to the ordering clinician, are reportable when performed on the following organisms:

(i) Pseudomonas aeruginosa, resistant to a carbapenem, or with demonstrated carbapenemase.

(d) The Department may, by authority granted through Section 26-23b, identify additional reporting criteria when deemed necessary for the management of outbreaks or identification of exposures.

( e[d]) Non-positive laboratory results reported for the events identified in Subsection R386-702-3([6]7)([c]b) will be used for the following purposes as authorized in Utah Health Code Subsections 26-1-30(2)(c), 26-1-30(2)(d), and 26-1-30(2)(f):

(i) To determine when a previously reported case becomes non-infectious;

(ii) To identify newly acquired infections through identification of a seroconversion window; or

(iii) To provide information critical for assignment of a case definition.

( f[e]) Information associated with a non-positive laboratory result will be kept by the Department for a period of 18 months.

(i) At the end of the 18 month period, if the result has not been appended to an existing case, personal identifiers will be stripped and expunged from the result.

(ii) The de-identified result will be added to a de-identified, aggregate dataset.

(iii) The dataset will be kept for use by public health to analyze trends associated with testing patterns and case distribution, and identify and establish prevention and intervention efforts for at-risk populations.

([7]8) Authorized Reporting of Syndromes and Conditions.

(a) Reporting of encounters for the following syndromes and conditions is authorized by Chapter 26-23b, unless made mandatory by the declaration of a public health emergency:

(i) Respiratory illness, including but not limited to:

(A) Upper or lower respiratory tract infections,

(B) Difficulty breathing, or

(ii) Gastrointestinal illness, including but not limited to:

(A) Vomiting,

(B) Diarrhea, or

(iii) Influenza-like constitutional symptoms or signs;

(iv) Neurologic symptoms or signs indicating the possibility of meningitis, encephalitis, or unexplained acute encephalopathy or delirium;

(v) Rash illness;

(vi) Hemorrhagic illness;

(vii) Botulism-like syndrome;

(viii) Lymphadenitis;

(ix) Sepsis or unexplained shock;

(x) Febrile illness (illness with fever, chills or rigors);

(xi) Nontraumatic coma or sudden death; and

(xii) Other criteria specified by the Department as indicative of disease outbreaks or injurious exposures of uncertain origin.

(b) Reporting of encounters for syndromes and conditions not specified in SubsectionR386-702-3([7]8)(a) is also authorized by Chapter 26-23b, unless made mandatory by the declaration of a public health emergency.

(c) Information included in the reporting of the events identified in Subsection R386-702-3([7]8)(a) and R386-702-3([7]8)(b) will be used for the following purposes:

(i) To support early identification and ruling out of public health threats, disasters, outbreaks, suspected incidents, and acts of bioterrorism;

(ii) To assist in characterizing population groups at greatest risk for disease or injury;

(iii) To support assessment of the severity and magnitude of possible threats; or

(iv) To satisfy syndromic surveillance objectives of the Federal Centers for Medicaid and Medicare Meaningful Use incentive program.

([8]9) Reporting Exceptions

(a) A university or hospital that conducts research studies exempt from reporting AIDS and HIV infection under Section 26-6-3.5 shall seek written approval of reporting exemption from the Department institutional review board prior to the study commencement.

(b) The university or hospital shall submit the following to the HIV Epidemiologist within 30 days of Department institutional review board approval:

(i) A summary of the research protocol, including funding sources and justification for requiring anonymity; and

(ii) Written approval from the Department institutional review board.

(c) The university or hospital shall submit a report that includes all of the indicators specified in Subsection 26-6-3.5(4)(a) to the HIV Epidemiologist annually during an ongoing research study.

(d) The university or hospital shall submit a final report that includes all of the indicators specified in Subsection 26-6-3.5(4)(a) to the HIV Epidemiologist within 30 days of the conclusion of the research study.

(e) Documents can be submitted to the HIV Epidemiologist by fax at (801) 538-9923 or by mail to 288 North 1460 West Salt Lake City, Utah 84116.

R386-702-4. Entities Required to Report.

(1) Section 26-6-6 lists those entities required to report cases or suspect cases of the reportable events set forth in Section R386-702-3. This includes:

(a) Health care providers, as defined in Section 78B-3-403;

(b) Health care facilities, as defined in Section 78B-3-403;

(d) Mental health facilities, as defined in Section 62A-15-602;

(e) Care facilities licensed through the Department of Human Services;

(f) Nursing care facilities and assisted living facilities, as defined in Section 26-21-2;

(g) Dispensaries;

(h) Clinics;

(i) Laboratories;

(j) Schools, as defined in Section 26-6-2;

(k) Childcare programs, as defined in Section 26-39-102; and

(l) Any individual with a knowledge of others who have a communicable disease.

(2) In addition, the following entities are required to report cases or suspect cases of the reportable events set forth in Section R386-702-3:

(a) Blood and plasma donation centers; and

(b) Correctional facilities

(3) When more than one entity is involved in the processing of a clinical specimen (receiving, forwarding, or analyzing); or the diagnosis, treatment, or care of a case or suspect case; all entities involved are required to report; even when diagnosis or testing is done outside of Utah.

(4) Health care entities may designate a single person or group of persons to report the events identified in Section R386-702-3 to public health on behalf of their health care providers or medical laboratories, as long as reporting complies with all requirements in this rule.

R386-702-5. Mandatory Submission of Clinical Material.

(1) Laboratories shall submit clinical material from all cases identified with organisms listed in Subsection R386-702-5(3) [~~below~~ ]to the Utah Department of Health, Utah Public Health Laboratory (UPHL) within three working days of identification.

(a) Clinical material is defined as:

(i) A clinical isolate containing the organism for which submission of material is required; or

(ii) If an isolate is not available, material containing the organism for which submission of material is required, in the following order of preference:

(A) a patient specimen,

(B) nucleic acid, or

(2) Laboratories submitting clinical material from cases identified with organisms designated by UPHL as potential bioterrorism [~~(BT)~~ ]agents shall first notify UPHL via telephone immediately.

(a) UPHL can be contacted during business hours at (801) 965-2400, or after hours at (801) 560-6586, of all bioterrorism[BT] agents that are being submitted.

(3) Organisms mandated for standard clinical submission include:

(a) Antibiotic resistant organisms from any clinical specimen that meet the following criteria:

(i) Resistant to a carbapenem, or with demonstrated carbapenemase, in:

(A) Acinetobacter species,

(B) Enterobacter species,

(D) Klebsiella species,

(E) Pseudomonas aeruginosa,

(ii) Resistant to vancomycin in:

(A) Staphylococcus aureus (VRSA);

([a]b) Campylobacter species;

([b]c) Candida auris or Candida haemulonii from any body site;

(d) Corynebacterium diphtheriae;

( e[c]) Shiga toxin-producing Escherichia coli (STEC), including enrichment and/or MacConkey broths that tested positive by any method for Shiga toxin;

( f[d]) Haemophilus influenzae, from normally sterile sites;

( g[e]) Influenza A virus, unsubtypeable;

( h[f]) Influenza virus (hospitalized cases only);

( i[g]) Legionella species;

( j[h]) Listeria monocytogenes;

( k[i]) Measles (rubeola) virus;

( l[j]) Mycobacterium tuberculosis complex;

( m[k]) Neisseria meningitidis, from normally sterile sites;

( n[l]) Salmonella species;

( o[m]) Shigella species;[

~~(n) Staphylococcus aureus that is resistant or intermediate resistant to vancomycin;~~]

( p[o]) Vibrio species;

( q[p]) West Nile virus;

( r[q]) Yersinia species;

( s[r]) Zika virus; and

( t[s]) Any organism implicated in an outbreak when instructed by authorized local or state health department personnel.

(4) Organisms mandated for bioterrorism[BT] clinical submission include:

(a) Bacillus anthracis;

(b) Brucella species;

(d) Francisella tularensis; and

(e) Yersinia pestis.

(5) Submission of clinical material does not replace the requirement for laboratories to report the event to public health as defined in Sections R386-702-6 and R386-702-7.

(6) For additional information on this process, contact UPHL at (801) 965-2400.

R386-702-6. Reporting Criteria.

(1) Manual Reporting

(a) Reporting Timeframes

(i) Entities shall report immediately reportable events by telephone as soon as possible, but no later than 24 hours after identification. Events designated as immediately reportable by the Department include cases and suspect cases of:

(A) Anthrax or anthrax-like illness;

(B) Botulism, excluding infant botulism;

(D) Diphtheria;

(E) Haemophilus influenzae, invasive disease;

(F) Hepatitis A;

(G) Influenza infection suspected or confirmed to be caused by a non-seasonal influenza strain;

(H) Measles;

(I) Meningococcal disease, invasive;

(J) Middle East Respiratory Syndrome (MERS);

([J]K) Plague;

([K]L) Poliovirus, paralytic and nonparalytic;

([L]M) Rabies, human and animal;

([M]N) Rubella, excluding congenital syndrome;

([N]O) Severe acute respiratory syndrome (SARS);

([O]P) Smallpox;

([P]Q) Staphylococcus aureus from any clinical specimen that is or intermediate resistant to vancomycin;

([Q]R) Transmissible spongiform encephalopathies (prion diseases), including Creutzfeldt-Jakob disease;

([R]S) Tuberculosis;

([S]T) Tularemia;

([T]U) Typhoid, cases and carriers;

([U]V) Viral hemorrhagic fevers;

([V]W) Yellow fever; or

([W]X) Any event described in Subsections R386-702-3([4]5) or R386-702-3([5]6).

(ii) Entities shall report all events in Subsections R386-702-3(2) [~~and~~]through R386-702-3([3]6) not required to be reported immediately within three working days from the time of identification.

(b) Methods for Reporting

(i) Entities reporting manually shall send reports to either a local health department or the Department by phone, secured fax, secured email, or mail.

(ii) Contact information for the Department is as follows:

(A) Phone: (801) 538-6191 during business hours, or 888-EPI-UTAH (888-374-8824) after hours;

(B) Secured fax: (801) 538-9923;

(D) Mail: 288 North 1460 West Salt Lake City, Utah 84116.

(iii) A confidential morbidity report form is available at: http://health.utah.gov/epi/reporting/.

(iv) The Department incorporates by reference version 2.0 of the Utah Reporting Specifications for Communicable Diseases, which identifies individual laboratory tests that shall be reported to the Department by manual reporting entities.

(2) Electronic Reporting

(a) Reporting Timeframes

(i) All entities that report electronically must report laboratory results within 24 hours of finalization.

(A) Entities can choose to report in real-time (as each report is released) or batch reports.

(B) Entities reporting electronically must report preliminary positive results for the immediately reportable events specified in Subsection R386-702-6(1)(a)(i).

(b) Methods for Reporting

(i) All laboratories that identify cases or suspect cases shall report to the[~~The~~] Department through electronic laboratory reporting, [~~strongly encourages hospitals and laboratories with the capacity to report events electronically to the Department,~~ ]in a manner approved by the Department. Reportable events shall be identified by automated computer algorithms.

(A) Laboratories may substitute electronic reporting if electronic laboratory reporting is not available, with permission from the Department, and in a manner approved by the Department.

(B) Hospitals reporting electronically shall use HL7 2.5.1 message structure, and standard LOINC and SNOMED terminology in accordance with Meaningful Use regulations.

(C) Laboratories reporting electronically shall use HL7 2.3.1 or 2.5.1 message structure, and appropriate LOINC codes designating the test performed.

(D) Entities reporting electronically shall submit all local vocabulary codes with translations to the Division of Disease Control and Prevention Informatics Program, if applicable.

(E) The Department incorporates by reference version 1.1 of the Utah Electronic Laboratory Reporting Specifications for Communicable Diseases, which identifies individual laboratory tests that shall be reported to the Department by electronic reporting entities.

(F) For additional information on this process, refer to https://health.utah.gov/phaccess/public/elr/ or contact the Division of Disease Control and Prevention Informatics Program by phone (801-538-6191) or email ([email protected]).

(ii) Electronic case reporting is an authorized method of reporting to the Department. For additional information on this process, contact the Division of Disease Control and Prevention Informatics Program by phone (801-538-6191) or email ([email protected]).[~~(ii) Hospitals reporting electronically shall use HL7 2.5.1 message structure, and standard LOINC and SNOMED terminology in accordance with Meaningful Use regulations.~~

~~(iii) Laboratories reporting electronically shall use HL7 2.3.1 or 2.5.1 message structure, and appropriate LOINC codes designating the test performed.~~

~~(A) Laboratories reporting electronically shall submit all local vocabulary codes with translations to the Division of Disease Control and Prevention Informatics Program, if applicable.~~]

(3) Syndromic Reporting

(a) Reporting Timeframes

(i) Entities reporting syndromes or conditions identified in Subsection R386-702-3([7]8) shall report as soon as practicable using a schedule approved by the Department.

(b) Methods for Reporting

(i) For information on reporting syndromic data, refer to https://health.utah.gov/phaccess/public/SS/ or contact the Division of Disease Control and Prevention Informatics Program by phone (801-538-6191) or email ([email protected]).

R386-702-7. Required Information.

(1) Entities shall include as much of the following information as is known when reporting events specified in Subsections R386-702-3(2) through R386-702-3(6) to public health:

(a) Patient information:

(i) Full name;

(ii) Date of birth;

(iii) Address, including street address, city, state, and zip code;

(iv) Telephone number;

(v) Gender;

(vi) Race and ethnicity;

(vii) Date of onset;

(viii) Hospitalization status and date of admission; and

(ix) Pregnancy status and estimated due date.

(b) Diagnostic information:

(i) Name of the diagnostic facility;

(ii) Address, including street address, city, state, and zip code; of the diagnostic facility;

(iii) Telephone number of the diagnostic facility;

(iv) Full name of the ordering or diagnosing health care provider;

(v) Address, including street address, city, state, and zip code; of the ordering or diagnosing health care provider; and

(vi) Telephone number of the ordering or diagnosing health care provider.

(i) Full name of the person reporting;

(ii) Name of the facility reporting; and

(iii) Telephone number of the person or facility reporting.

(d) Laboratory testing information:

(i) Name of the laboratory performing the test;

(ii) The laboratory's name for, or description of, the test;

(iii) Specimen source;

(iv) Specimen collection date;

(v) Testing results;

(vi) Test reference range; and

(vii) Test status (e.g. preliminary, final, amended and/or corrected).

(2) Entities shall submit reports that are clearly legible and do not contain any internal codes or abbreviations to the Department.

(3) Entities ordering a laboratory test identified in the Utah Electronic Laboratory Reporting Specifications for Communicable Diseases shall provide the performing laboratory with the patient's address, so that the performing laboratory can report results to the appropriate public health agency.

(a) If the patient's address is not known by the ordering entity, the ordering entity shall provide the performing laboratory with the name and address of the diagnostic facility.

(4) Entities shall reference http://health.utah.gov/epi/reporting, or contacting the Department at (801) 538-6191, for additional reporting specifications, including technical documents, reporting forms, and protocols.

( 5[4]) Full reporting of all relevant patient information is authorized when reporting events listed in Subsection R386-702-3([7]8) to public health.

(a) Entities shall include in reports at least the following information, if known:

(i) Name of the facility;

(ii) A patient identifier;

(iii) Date of visit;

(iv) Time of visit;

(v) Patient's age;

(vi) Patient's gender;

(vii) Zip code of patient's residence;

(viii) Chief complaint(s), reason for visit, and/or diagnosis; and

(ix) Whether the patient was admitted to the hospital.

R386-702-8. Confidentiality of Reports.

(1) All reports required by this rule are confidential and are not open to public inspection. All information collected pursuant to this rule shall not be released or made public, except as provided by Section 26-6-27. Penalties for violation of confidentiality are prescribed in Section 26-6-29.

(2) Nothing in this rule precludes the discussion of case information with an attending clinician or public health workers.

(3) Good Samaritans

(a) The Department or local health department shall disclose communicable disease-related information regarding the person who was assisted to the medical provider of a Good Samaritan when that medical provider submits a request to the Department or local health department. The request must include:

(i) Information regarding the occurrence of the accident, fire, or other life-threatening emergency;

(ii) A description of the exposure risk to the Good Samaritan; and

(iii) Contact information for the Good Samaritan and their medical provider.

(b) The Department or local health department will ensure that the disclosed information:

(i) Includes enough detail to allow for appropriate education and follow-up to the Good Samaritan; and

(ii) Ensures confidentiality is maintained for the person who was aided.

(c) No identifying information will be shared with the Good Samaritan or their medical provider regarding the person who was assisted. The Good Samaritan shall receive written information warning them that information regarding the person who was assisted is protected by state law.

R386-702-9. Non-Compliance with Reporting Regulations.

(1) Any person who violates any provision of Section R386-702 may be assessed a penalty as provided in Section 26-23-6.

(a) Willful non-compliance may result in the Department working with other agencies to incur penalties which may include loss of accreditation or licensure.

(2) Records maintained by reporting entities are subject to review by Department personnel to assure the completeness and accuracy of reporting.

(3) If public health conducts a surveillance project, such as assessing the completeness of case finding or assessing another measure of data quality, the Department may, at its discretion, waive any penalties for participating entities if cases are found that were not originally reported for whatever reason.

R386-702-10. Information Necessary for Public Health Investigation and Surveillance.

(1) Reporting entities shall provide the Department or local health department with any records or other materials requested by public health that are necessary to conduct a thorough investigation.

(a) This includes, but is not limited to, medical records, additional laboratory testing results, treatment and vaccination history, clinical material, or contact information for cases, suspect cases, or persons potentially exposed.

(b) The Department or local health department shall be granted on-site access to a facility, when such access is critical to a public health investigation.

R386-702-11. General Measures for the Control of Communicable Diseases.

(1) The local health department shall maintain all reportable disease records as needed to enforce Chapter 6 of the Health Code and this rule, or as requested by the Utah Department of Health.

(2) General Control Measures for Reportable Diseases.

(a) The local health department shall, when an unusual or rare disease occurs in any part of the state or when any disease becomes so prevalent as to endanger the state as a whole, contact the Bureau of Epidemiology, Utah Department of Health for assistance, and shall cooperate with the representatives of the Utah Department of Health.

(b) The local health department shall investigate and control the causes of epidemic, infectious, communicable, and other disease affecting the public health. The local health department shall also provide for the detection, reporting, prevention, and control of communicable, infectious, and acute diseases that are dangerous or important or that may affect the public health. The local health department may require physical examination and measures to be performed as necessary to protect the health of others.

(c) If, in the opinion of the local health officer it is necessary or advisable to protect the public's health that any person shall be kept from contact with the public, the local health officer shall establish, maintain and enforce involuntary treatment, isolation and quarantine as provided by Section 26-6-4. Control measures shall be specific to the known or suspected disease agent. Guidance is available from the Bureau of Epidemiology, Utah Department of Health or official reference listed in R386-702-1 8[2].

(3) Prevention of the Spread of Disease From a Case.

The local health department shall take action and measures as may be necessary within the provisions of Section 26-6-4; Title 26, Chapter 6b; and this rule, to prevent the spread of any communicable disease, infectious agent, or any other condition which poses a public health hazard. Action shall be initiated upon discovery of a case or upon receipt of notification or report of any disease.

(4) Prevention of the Spread of Disease or Other Public Health Hazard.

A case, suspected case, carrier, contact, other person, or entity (e.g. facility, hotel, organization) shall, upon request of a public health authority, promptly cooperate during:

(a) An investigation of the circumstances or cause of a case, suspected case, outbreak, or suspected outbreak.

(b) The carrying out of measures for prevention, suppression, and control of a public health hazard, including, but not limited to, procedures of restriction, isolation, and quarantine.

(5) Public Food Handlers.

A person known to be infected with a communicable disease that can be transmitted by food or drink products, or who is suspected of being infected with such a disease, may not engage in the commercial handling of food or drink products, or be employed on any premises handling those types of products, unless those products are packaged off-site and remain in a closed container until purchased for consumption, until the person is determined by the local health department to be free of communicable disease, or incapable of transmitting the infection.

(6) Communicable Diseases in Places Where Food or Drink Products are Handled or Processed.

If a case, carrier, or suspected case of a disease that can be conveyed by food or drink products is found at any place where food or drink products are handled or offered for sale, or if a disease is found or suspected to have been transmitted by these food or drink products, the local health department may immediately prohibit the sale, or removal of drink and all other food products from the premises. Sale or distribution of food or drink products from the premises may be resumed when measures have been taken to eliminate the threat to health from the product and its processing as prescribed by R392-100.

(7) Request for State Assistance.

If a local health department finds it is not able to completely comply with this rule, the local health officer or his representative shall request the assistance of the Utah Department of Health. In such circumstances, the local health department shall provide all required information to the Bureau of Epidemiology. If the local health officer fails to comply with the provisions of this rule, the Utah Department of Health shall take action necessary to enforce this rule.

(8) Approved Laboratories.

Laboratory analyses that are necessary to identify the causative agents of reportable diseases or to determine adequacy of treatment of patients with a disease shall be ordered by the physician or other health care provider to be performed in or referred to a laboratory holding a valid certificate under the Clinical Laboratory Improvement Amendments of 1988.

R386-702-12. Special Measures for Control of Rabies.

(1) Rationale of Treatment.

A physician must evaluate individually each exposure to possible rabies infection. The physician shall also consult with local or state public health officials if questions arise about the need for rabies prophylaxis.

(2) Management of Biting Animals.

(a) A healthy dog, cat, or ferret that bites a person shall be confined and observed at least daily for ten days from the date of bite, regardless of vaccination status, as specified by local animal control ordinances. It is recommended that rabies vaccine not be administered during the observation period. Such animals shall be evaluated by a veterinarian at the first sign of illness during confinement. A veterinarian or animal control officer shall immediately report any illness in the animal to the local health department. If signs suggestive of rabies develop, a veterinarian or animal control officer shall direct that the animal be euthanized, its head removed, and the head shipped under refrigeration, not frozen, for examination of the brain by a laboratory approved by the Utah Department of Health.

(b) If the dog, cat, or ferret shows no signs of rabies or illness during the ten day period, the veterinarian or animal control officer shall direct that the unvaccinated animal be vaccinated against rabies at the owner's expense before release to the owner. If a veterinarian is not available, the animal may be released, but the owner shall have the animal vaccinated within 72 hours of release. If the dog, cat, or ferret was appropriately vaccinated against rabies before the incident, the animal may be released from confinement after the 10-day observation period with no further restrictions.

(c) Any stray or unwanted dog, cat, or ferret that bites a person may be euthanized immediately by a veterinarian or animal control officer, if permitted by local ordinance, and the head submitted, as described in R386-702-[6]12(2)(a), for rabies examination. If the brain is negative by fluorescent-antibody examination for rabies, one can assume that the saliva contained no virus, and the person bitten need not be treated.

(d) Wild animals include raccoons, skunks, coyotes, foxes, bats, the offspring of wild animals crossbred to domestic dogs and cats, and any carnivorous animal other than a domestic dog, cat, or ferret.

(e) Signs of rabies in wild animals cannot be interpreted reliably. If a wild animal bites or scratches a person, the person or attending medical personnel shall notify an animal control or law enforcement officer. A veterinarian, animal control officer or representative of the Division of Wildlife Resources shall kill the animal at once, without unnecessary damage to the head, and submit the brain, as described in R386-702-[6]12(2)(a), for examination for evidence of rabies. If the brain is negative by fluorescent-antibody examination for rabies, one can assume that the saliva contained no virus, and the person bitten need not be treated.

(f) Rabbits, opossums, squirrels, chipmunks, rats, and mice are rarely infected and their bites rarely, if ever, call for rabies prophylaxis or testing. Unusual exposures to any animal should be reported to the local health department or the Bureau of Epidemiology, Utah Department of Health.

(g) When rare, valuable, captive wild animals maintained in zoological parks approved by the United States Department of Agriculture or research institutions, as defined by Section 26-26-1, bite or scratch a human, the Bureau of Epidemiology, Utah Department of Health shall be notified. The provisions of subsection R386-702-[6]12(2)(e) may be waived by the Bureau of Epidemiology, Utah Department of Health if zoological park operators or research institution managers can demonstrate that the following rabies control measures are established:

(i) Employees who work with the animal have received preexposure rabies immunization.

(ii) The person bitten by the animal voluntarily agrees to accept postexposure rabies immunization provided by the zoological park or research facility.

(iii) The director of the zoological park or research facility shall direct that the biting animal be held in complete quarantine for a minimum of four months for dogs and cats, and six months for ferrets. Quarantine requires that the animal be prohibited from direct contact with other animals or humans.

(h) Any animal bitten or scratched by a wild, carnivorous animal or a bat that is not available for testing shall be regarded as having been exposed to rabies. The animal shall be placed in a strict quarantine for four months for dogs and cats, or six months for ferrets.

(i) For maximum protection of the public health, unvaccinated dogs, cats, and ferrets bitten or scratched by a confirmed or suspected rabid animal shall be euthanized immediately by a veterinarian or animal control officer. If the owner is unwilling to have the animal euthanized, the local health officer shall order that the animal be held in strict isolation in a municipal or county animal shelter or a veterinary medical facility approved by the local health department, at the owner's expense, for at least four months for dogs and cats, and six months for ferrets. The animal shall be vaccinated one month before being released. If any illness suggestive of rabies develops in the animal, the veterinarian or animal control officer shall immediately report the illness to the local health department and the veterinarian or animal control officer shall direct that the animal be euthanized and the head shall be handled as described in subsection R386-702-[6]12(2)(a).

(j) Dogs, cats, and ferrets that are currently vaccinated and are bitten by rabid animals, shall be revaccinated immediately by a veterinarian and confined and observed by the animal's owner for 45 days. If any illness suggestive of rabies develops in the animal, the owner shall report immediately to the local health department and the animal shall be euthanized by a veterinarian or animal control officer and the head shall be handled as described in subsection R386-702-[6]12(2)(a).

(k) Livestock exposed to a rabid animal and currently vaccinated with a vaccine approved by the United States Department of Agriculture for that species shall be revaccinated immediately by a veterinarian and observed by the owner for 45 days. Unvaccinated livestock shall be slaughtered immediately. If the owner is unwilling to have the animal slaughtered, the animal shall be kept under close observation by the owner for six months.

(l) Unvaccinated animals other than dogs, cats, ferrets, and livestock bitten by a confirmed or suspected rabid animal shall be euthanized immediately by a veterinarian or animal control officer.

(3) Testing Fees at Utah Public Health Laboratory (UPHL).

(a) Animals being submitted to UPHL for rabies testing must follow criteria defined in The Compendium of Animal Rabies Prevention and Control to be eligible for testing without a fee. Testing of animals that fit this criteria will be eligible for a waived fee for testing. Testing of animals that do not meet this criteria will incur a testing fee as set forth by UPHL.

(b) The following situations will not incur a rabies testing fee if testing is ordered for them through UPHL:

(i) Any bat in an instance where a person or animal has had an exposure, or reasonable probability of exposure, including, but not limited to: known bat bites, exposure to bat saliva, a bat found in a room with a sleeping person or unattended child, or a bat found near a child or mentally impaired or intoxicated person.

(ii) Dogs, cats, or ferrets, regardless of rabies vaccination status, if signs suggestive of rabies are documented in them.

(iii) Wild mammals and hybrids that expose persons, pets, or livestock (e.g., skunks, foxes, coyotes, and raccoons) may be tested.

(iv) Livestock may be tested if signs suggestive of rabies are documented.

(v) UDOH Bureau of Epidemiology staff are available to discuss additional situations that may warrant testing at (801) 538-6191.

(i) Any stray with unknown or undocumented vaccination history that exposes a person, if signs suggestive of rabies are not documented, or if the animal has not been confined and observed for at least 10 days.

(ii) Dogs, cats, and ferrets: currently vaccinated animals that expose a person, if signs suggestive of rabies are not documented, or animals have not been confined and observed for at least 10 days.

(iii) Regardless of rabies vaccination status, a healthy dog, cat, or ferret that has not exposed a person.

(iv) Small rodents (e.g., rats, mice, squirrels, chipmunks, voles, or moles) and lagomorphs (rabbits and hares).

(v) Incomplete paperwork accompanying the sample will also result in a fee for testing; a thorough description of the situation must be included with each sample submission.

(vi) UDOH Bureau of Epidemiology staff are available to discuss additional situations that may not warrant testing at (801) 538-6191.

(d) If the submitting party feels they are charged inappropriately for rabies testing, they may send a letter describing the situation and requesting a waiver for fees to the: Utah Department of Health, Bureau of Epidemiology, P.O. Box 142104, Salt Lake City, UT 84114, attention: Zoonotic Diseases Epidemiologist. Information may be submitted electronically via email to: [email protected], with a note in the subject line "Attention: Zoonotic Diseases Epidemiologist".

(i) The submitting party has 30 days from receipt of the testing fee invoice to file an appeal. The letter must include copies of the original paperwork that was submitted, and a copy of the invoice received, for a waiver to be considered.

(ii) UDOH and UPHL have 30 days to review information after receipt of an appeal request to make an official decision and notify the submitter.

(iii) UDOH Bureau of Epidemiology staff are available to discuss questions about testing fees and the appeal process at (801) 538-6191.

(4) Measures for Standardized Rabies Control Practices.

(a) Humans requiring either pre- or post-exposure rabies prophylaxis shall be treated in accordance with the recommendations of the U.S. Public Health Service Immunization Practices Advisory Committee, as adopted and incorporated by reference in R386-702-18[2](2). A copy of the recommendations shall be made available to licensed medical personnel, upon request to the Bureau of Epidemiology, Utah Department of Health.

(b) A physician or other health care provider that administers rabies vaccine shall immediately report all serious systemic neuroparalytic or anaphylactic reactions to rabies vaccine through the Vaccine Adverse Event Reporting System (VAERS)[~~to the Bureau of Epidemiology, Utah Department of Health, using the process described in R386-702-4~~].

(c) The Compendium of Animal Rabies Prevention and Control, as adopted and incorporated by reference in R386-702-1 8[2]( 5[3]), is the reference document for animal vaccine use.

(d) A county, city, town, or other political subdivision that requires licensure of animals shall also require rabies vaccination as a prerequisite to obtaining a license.

(e) Animal rabies vaccinations are valid only if performed by or under the direction of a licensed veterinarian in accordance with the Compendium of Animal Rabies Prevention and Control.

(f) All agencies and veterinarians administering vaccine shall document each vaccination on the National Association of State Public Health Veterinarians (NASPHV) form number 51, Rabies Vaccination Certificate, which can be obtained from vaccine manufacturers. The agency or veterinarian shall provide a copy of the report to the animal's owner. Computer-generated forms containing the same information are also acceptable.

(g) Animal rabies vaccines may be sold or otherwise provided only to licensed veterinarians or veterinary biologic supply firms. Animal rabies vaccine may be purchased by the Utah Department of Health and the Utah Department of Agriculture.

(5) Measures to Prevent or Control Rabies Outbreaks.

(a) The most important single factor in preventing human rabies is the maintenance of high levels of immunity in the pet dog, cat, and ferret populations through vaccination.

(i) All dogs, cats, and ferrets in Utah should be immunized against rabies by a licensed veterinarian; and

(ii) Local governments should establish effective programs to ensure vaccination of all dogs, cats, and ferrets and to remove strays and unwanted animals.

(b) If the Utah Department of Health determines that a rabies outbreak is present in an area of the state, the Utah Department of Health may require that:

(i) all dogs, cats, and ferrets in that area and adjacent areas be vaccinated or revaccinated against rabies as appropriate for each animal's age;

(ii) any such animal be kept under the control of its owner at all times until the Utah Department of Health declares the outbreak to be resolved;

(iii) an owner who does not have an animal vaccinated or revaccinated surrender the animal for confinement and possible destruction; and

(iv) such animals found at-large be confined and possibly destroyed.

R386-702-13. Special Measures for Control of Typhoid.

(1) Because typhoid control measures depend largely on sanitary precautions and other health measures designed to protect the public, the local health department shall investigate each case of typhoid and strictly manage the infected individual according to the following outline:

(2) Cases: Standard precautions are required during hospitalization. Use contact precautions for diapered or incontinent patients for the duration of illness. Hospital care is desirable during acute illness. Release of the patient from supervision by the local health department shall be based on three or more negative cultures of feces (and of urine in patients with schistosomiasis) taken at least 24 hours apart. Cultures must have been taken at least 48 hours after antibiotic therapy has ended and not earlier than one month after onset of illness as specified in R386-702-[7]13(6). If any of these cultures is positive, repeat cultures at intervals of one month during the 12-month period following onset until at least three consecutive negative cultures are obtained as specified in R386-702-[7]13(6). The patient shall be restricted from food handling, child care, and from providing patient care during the period of supervision by the local health department.

(3) Contacts: Administration of typhoid vaccine is recommended for all household members of known typhoid carriers. Household and close contacts of a carrier shall be restricted from food handling, child care, and patient care until two consecutive negative stool specimens, taken at least 24 hours apart, are submitted, or when approval is granted by the local health officer according to local jurisdiction.

(4) Carriers: If a laboratory or physician identifies a carrier of typhoid, the attending physician shall immediately report the details of the case by telephone to the local health department or the Bureau of Epidemiology, Utah Department of Health using the process described in R386-702-[4]6. Each infected individual shall submit to the supervision of the local health department. Carriers are prohibited from food handling, child care, and patient care until released in accordance with R386-702-[7]13(4)(a) or R386-702-[7]13(4)(b). All reports and orders of supervision shall be kept confidential and may be released only as allowed by Subsection 26-6-27(2)(c).

(a) Convalescent Carriers: Any person who harbors typhoid bacilli for three but less than 12 months after onset is defined as a convalescent carrier. Release from occupational and food handling restrictions may be granted at any time from three to 12 months after onset, as specified in R386-702-[7]13(6).

(b) Chronic Carriers: Any person who continues to excrete typhoid bacilli for more than 12 months after onset of typhoid is a chronic carrier. Any person who gives no history of having had typhoid or who had the disease more than one year previously, and whose feces or urine are found to contain typhoid bacilli is also a chronic carrier.

(c) Other Carriers: If typhoid bacilli are isolated from surgically removed tissues, organs, including the gallbladder or kidney, or from draining lesions such as osteomyelitis, the attending physician shall report the case to the local health department or the Bureau of Epidemiology, Utah Department of Health. If the person continues to excrete typhoid bacilli for more than 12 months, he is a chronic carrier and may be released after satisfying the criteria for chronic carriers in R386-702-[7]13(6).

(5) Carrier Restrictions and Supervision: The local health department shall report all typhoid carriers to the Bureau of Epidemiology, and shall:

(a) Require the necessary laboratory tests for release;

(b) Issue written instructions to the carrier;

(6) Requirements for Release of Convalescent and Chronic Carriers: The local health officer or his representative may release a convalescent or chronic carrier from occupational and food handling restrictions only if at least one of the following conditions is satisfied:

(a) For carriers without schistosomiasis, three consecutive negative cultures obtained from fecal specimens authenticated by the attending physician, hospital personnel, laboratory personnel, or local health department staff taken at least one month apart and at least 48 hours after antibiotic therapy has stopped;

(b) for carriers with schistosomiasis, three consecutive negative cultures obtained from both fecal and urine specimens authenticated by the attending physician, hospital personnel, laboratory personnel, or local health department staff taken at least one month apart and at least 48 hours after antibiotic therapy has stopped;

(c) the local health officer or his representative determine that additional treatment such as cholecystectomy or nephrectomy has terminated the carrier state; or

(d) the local health officer or his representative determines the carrier no longer presents a risk to public health according to the evaluation of other factors.

R386-702-14. Special Measures for the Control of Ophthalmia Neonatorum.

Every physician or midwife practicing obstetrics or midwifery shall, within three hours of the birth of a child, instill or cause to be instilled in each eye of such newborn one percent silver nitrate solution contained in wax ampules, or tetracycline ophthalmic preparations or erythromycin ophthalmic preparations, as these are the only antibiotics of currently proven efficacy in preventing development of ophthalmia neonatorum. The value of irrigation of the eyes with normal saline or distilled water is unknown and not recommended.

R386-702-15. Special Measures for the Control of HIV/AIDS.

(1) Partner identification and notification:

(a) If an individual is tested and found to have an HIV infection, the Department and/or local health department shall provide partner services, linkage-to-care activities, and promote retention to HIV care.

(2) Definitions:

(a) "Partner" is defined as any individual, including a spouse, who has shared needles, syringes, or drug paraphernalia or who has had sexual contact with an HIV infected individual.

(b) "Spouse" is defined as any individual who is the marriage partner of that person at any time within the ten-year period prior to the diagnosis of HIV infection.

(c) "Linkage to care" is defined by a reported CD4+ T-Lymphocyte test and/or HIV viral load determination within three months of HIV positive diagnosis.

(d) "Retention to care" is defined by a reported CD4+ T-Lymphocyte test or HIV viral load determination [~~twice~~] once within a 12-month period[~~and at least three months apart~~].

(3) Partner services include:

(a) Confidential partner notification within 30 days of receiving a positive HIV result or when relevant additional information is found to aide in an investigation or case management;

(b) Prevention counseling;

(d) Providing recommendations for testing for other sexually transmitted diseases;

(e) Providing recommendations for hepatitis screening and vaccination;

(f) Treatment or linkage to medical care on an ongoing basis, as needed[~~within three months of HIV diagnosis~~]; and

(g) Linkage or referral to other prevention services and support.

(4) Re-engagement to care includes:

(a) Linkage to medical care, on an ongoing basis, as needed;

(b) Linkage or referral to other prevention services and support;

(d) Prevention counseling;

(e) Providing recommendations for testing for other sexually transmitted diseases;

(f) Providing recommendations for hepatitis screening and vaccination;

(g) Medication adherence counseling; and

(h) Risk reduction counseling.

R386-702-16. Special Measures to Prevent Perinatal and Person-to-Person Transmission of Hepatitis B Infection.

(1) A licensed healthcare provider who provides prenatal care shall routinely test each pregnant woman for hepatitis B surface antigen (HBsAg) at an early prenatal care visit. The provisions of this section do not apply if the pregnant woman, after being informed of the possible consequences, objects to the test on the basis of religious or personal beliefs.

(2) The licensed healthcare provider who provides prenatal care shall repeat the HBsAg test during late pregnancy for those women who tested negative for HBsAg during early pregnancy, but who are at high risk based on:

(a) evidence of clinical hepatitis during pregnancy;

(b) injection drug use;

(d) occurrence of hepatitis B in a household or close family contact; or

(e) the judgment of the healthcare provider.

(3) In addition to other reporting required by this rule, each positive HBsAg result detected in a pregnant woman shall be reported to the local health department or the Department, as specified in Section 26-6-6. That report shall indicate that the woman was pregnant at time of testing if that information is available to the reporting entity.

(4) A licensed healthcare provider who provides prenatal care shall document a woman's HBsAg test results, or the basis of the objection to the test, in the medical record for that patient.

(5) Every hospital and birthing facility shall develop a policy to assure that:

(a) when a pregnant woman is admitted for delivery, or for monitoring of pregnancy status, the result from a test for HBsAg performed on that woman during that pregnancy is available for review and documented in the hospital record;

(b) when a pregnant woman is admitted for delivery, if the woman's test result is not available to the hospital or birthing facility, the mother is tested for HBsAg as soon as possible, but before discharge from the hospital or birthing facility;

(c) if a pregnant woman who has not had prenatal care during that pregnancy is admitted for monitoring of pregnancy status only, and if the woman's test result is not available to the hospital or birthing facility, the mother is tested for HBsAg status before discharge from the hospital or birthing facility;

(d) positive HBsAg results identified by testing performed or documented during the hospital stay are reported as specified in this rule;

(e) infants born to HBsAg positive mothers receive hepatitis B immune globulin (HBIG) and hepatitis B vaccine, administered at separate injection sites, within 12 hours of birth;

(f) infants born to mothers whose HBsAg status is unknown receive hepatitis B vaccine within 12 hours of birth, and if the infant is born preterm with birth weight less than 2,000 grams, that infant also receives HBIG within 12 hours; and

(g) if at the time of birth the mother's HBsAg status is unknown and the HBsAg test result is later determined to be positive, that infant receives HBIG as soon as possible but within 7 days of birth.

(h) hepatitis B immune globulin (HBIG) administration and birth dose hepatitis B vaccine status of infants born to mothers who are HBsAg-positive are reported within 24 hours of delivery to the local health department and Utah Department of Health Immunization Program at (801) 538-9450.

(6) Local health departments shall perform the following activities or assure that they are performed:

(a) All females between the ages of 12 and 50 years at the time an HBsAg positive test result is reported will be screened for pregnancy status within one week of receipt of that lab result.

(b) Infants born to HBsAg positive mothers complete the hepatitis B vaccine series as specified in in the most current version of "The Red Book" as cited in R386-702-13 (4).

(c) Children born to HBsAg positive mothers are tested for HBsAg and antibody against hepatitis B surface antigen (anti-HBs) at 9 to 12 months of age (testing is done at least one month after the final dose of hepatitis B vaccine series is administered, and no earlier than 9 months of age) to monitor the success of therapy and identify cases of perinatal hepatitis B infection.

(i) Children who test negative for HBsAg and do not demonstrate serological evidence of immunity against hepatitis B when tested as described in (c) receive three additional vaccine doses and are retested as specified in the most current version of "The Red Book" as cited in R386-702-1[3]8 (4).

(d) HBsAg positive mothers are advised regarding how to reduce their risk of transmitting hepatitis B to others.

(e) Household members and sex partners of HBsAg positive mothers are evaluated to determine susceptibility to hepatitis B infection and if determined to be susceptible, are offered or advised to obtain vaccination against hepatitis B.

(i) All identified acute hepatitis B cases shall be investigated by the local health department, and identified household and sexual contacts shall be advised to obtain vaccination against hepatitis B.

(7) The provisions of subsections (5) and (6) do not apply if the pregnant woman or the child's guardian, after being informed of the possible consequences, objects to any of the required procedures on the basis of religious or moral beliefs. The hospital or birthing facility shall document the basis of the objection.

(8) Prevention of transmission by individuals with chronic hepatitis B infection.

(a) The Department defines a chronic hepatitis B case as a person that is HBsAg positive, total antibody against hepatitis B core antigen (anti-HBc) positive (if performed) and IgM anti-HBc negative.

(b) An individual with chronic hepatitis B infection shall be advised regarding how to reduce the risk that the individual will transmit hepatitis B to others.

(c) Household members and sex partners of individuals with chronic hepatitis B infection shall be evaluated to determine susceptibility to hepatitis B infection, and if determined to be susceptible, shall be offered or advised to obtain vaccination against Hepatitis B.

R386-702-17. Public Health Emergency.

(1) Declaration of Emergency: With the Governor's and Executive Director's or in the absence of the Executive Director, his designee's, concurrence, the Department or a local health department may declare a public health emergency by issuing an order mandating reporting emergency illnesses or health conditions specified in sections R386-702-3 for a reasonable time.

(2) For purposes of an order issued under this section and for the duration of the public health emergency, the following definitions apply.

(a) "emergency center" means:

(i) a health care facility licensed under the provisions of Chapter 26-21 that operates an emergency department; or

(ii) a clinic that provides emergency or urgent health care to an average of 20 or more persons daily.

(b) "encounter" means an instance of an individual presenting at the emergency center who satisfies the criteria in section R386-702-3(2); and

(c) "diagnostic information" means an emergency center's records of individuals who present for emergency or urgent treatment, including the reason for the visit, chief complaint, results of diagnostic tests, presenting diagnosis, and final diagnosis, including diagnostic codes.

(3) Reporting Encounters: The Department shall designate the fewest number of emergency centers as is practicable to obtain the necessary data to respond to the emergency.

(a) Designated emergency centers shall report using the process described in R386-702-[4]6.

(b) An emergency center designated by the Department shall report the encounters to the Department by:

(i) allowing Department representatives or agents, including local health department representatives, to review its diagnostic information to identify encounters during the previous day; or

(ii) reviewing its diagnostic information on encounters during the previous day and reporting all encounters by 9:00 a.m. the following day, or

(iii) identifying encounters and submitting that information electronically to the Department, using a computerized analysis method, and reporting mechanism and schedule approved by the Department; or

(iv) by other arrangement approved by the Department.

(4) For purposes of epidemiological and statistical analysis, the emergency center shall report on encounters during the public health emergency that do not meet the definition for a reportable emergency illness or health condition. The report shall be made using the process described in R386-702-[4]6 and shall include the following information for each such encounter:

(a) facility name;

(b) date of visit;

(d) patient's age;

(e) patient's sex;

(f) patient's zip code for patient's residence.

(5) If either the Department or a local health department collects identifying health information on an individual who is the subject of a report made mandatory under this section, it shall destroy that identifying information upon the earlier of its determination that the information is no longer necessary to carry out an investigation under this section or 180 days after the information was collected. However, the Department and local health departments shall retain identifiable information gathered under other sections of this rule or other legal authority.

(6) Reporting on encounters during the public health emergency does not relieve a reporting entity of its responsibility to report under other sections of this rule or other legal authority.

R386-702-18. Official References.

All treatment and management of individuals and animals who have or are suspected of having a communicable or infectious disease that must be reported pursuant to this rule shall comply with the following documents, which are adopted and incorporated by reference:

(1) American Public Health Association. "Control of Communicable Diseases Manual". 20th ed., Heymann, David L., editor, 2015.

(2) Centers for Disease Control and Prevention. "Human Rabies Prevention---United States, 2008: Recommendations of the Advisory Committee on Immunization Practices." Morbidity and Mortality Weekly Report. 57 (RR03) (2008):1-26, 28.

(3) National Association of State Public Health Veterinarians Committee. "Compendium of Animal Rabies Prevention and Control, 2016." Nasphv.org. National Association of State Public Health Veterinarians, 18 October 2016. Web. http://nasphv.org/Documents/NASPHVRabiesCompendium.pdf

(4) American Academy of Pediatrics. "Red Book: 201[2]5 Report of the Committee on Infectious Diseases" 30th Edition. Elk Grove Village, IL, American Academy of Pediatrics; 2015.

(5) National Association of State Public Health Veterinarians Animal Contact Compendium Committee 2013. "Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2013." Journal of the American Veterinary Medicine Association 243 (2013): 1270-288.

KEY: communicable diseases, quarantines, rabies, rules and procedures

Date of Enactment or Last Substantive Amendment: [~~January 27~~], 2017

Notice of Continuation: April 15, 2016

Authorizing, and Implemented or Interpreted Law: 26-1-30; 26-6-3; 26-23b

Additional Information

More information about a Notice of Proposed Rule is available online.

The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull_pdf/2017/b20171115.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.

Text to be deleted is struck through and surrounded by brackets ([~~example~~]). Text to be added is underlined (example). Older browsers may not depict some or any of these attributes on the screen or when the document is printed.

For questions regarding the content or application of this rule, please contact Melissa Stevens Dimond at the above address, by phone at 801-538-6810, by FAX at 801-538-9923, or by Internet E-mail at [email protected]. For questions about the rulemaking process, please contact the Office of Administrative Rules.

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