DAR File No. 38883

Health, Disease Control and Prevention, Epidemiology

Rule R386-702

Communicable Disease Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 38883
Filed: 09/26/2014 12:44:48 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to correct punctuation and clarify language as needed; add conditions that have become nationally notifiable to Utah's reportable conditions list; clarify language for reporting laboratories, including adding information regarding electronic reporting for laboratories choosing to use this option; move information regarding HIV/AIDS special control measures from R388 to R386; clarify language pertaining to management of hepatitis B (including perinatal hepatitis B); and update information for references as needed.

Summary of the rule or change:

Proposed changes reflect suggestions and requests from leadership and stakeholders, including: Dr. Rolfs; Dr. Nakashima; Jennifer Brown (Utah Department of Health (UDOH)); Dr. Atkinson (Utah Public Health Laboratory (UPHL)); the Utah Epidemiology Affiliate Group; Salt Lake County Health Department; Dr. Gesteland (Intermountain Healthcare); Cathy Gray, Karri Hoopes (Infection Control Practitioners); Bureau of Epidemiology Programs and Teams (CD Analysis and Reporting, CD Investigation and Response, Informatics, Immunizations, Prevention, Treatment and Care, TB); and the Hepatitis B Workgroup. In Section R386-702-1, revised purpose statement to delete "recent" and "new" to better and more accurately describe emergence of diseases. In Section R386-702-2, revised the definition of "outbreak" to clarify and broaden the definition in order to encourage early recognition and investigation of possible outbreaks. Also, revised the definition of "case" to emphasize criteria that must be met to make an event reportable, and corrected punctuation for "suspect case" definition. In Section R386-702-3, added "anaplasmosis" and "leptospirosis" to ensure Utah is collecting information on these nationally-notifiable conditions. Also, added "Mycobacteria other than tuberculosis" (TB). Laboratories report non-TB Mycobacteria results now, though not consistently. These results allow public health to rule out suspect TB cases. Adding non-TB Mycobacteria allows results to be reported through electronic laboratory reporting, and will facilitate continued reporting by laboratories. Also, added "patient encounter data" and language defining this data in order to support early identification (or ruling out) of public health threats, and facilitate other objectives of syndromic surveillance; clarified language within "Acinetobacter" condition; modified language in "hepatitis B" condition to standardize terminology used for hepatitis B and hepatitis C; changed "norovirus" condition to be reportable for outbreaks only; updated reference information within "Human Immunodeficiency Virus Infection" condition since information is being moved from Title R388 to Title R386; sSimplified language for "poliomyelitis" condition to make it one condition with two manifestations (paralytic and nonparalytic) vs. two separate conditions; clarified language for "Q Fever" condition to ensure reporting of Coxiella species, since Coxiella is the bacterium associated with Q Fever; simplified language for "rubella" condition to make it one condition with two manifestations (rubella and rubella, congenital syndrome) vs. two separate conditions; corrected spelling of "staphylococcal" in "Toxic-Shock Syndrome?" condition; and updated "trichinellosis" condition to reflect the more commonly used name. In Section R386-702-4, clarified information for reporting laboratories by: adding a reference to Subsection R386-702-4(4) in order to assist laboratories in locating the immediately reportable conditions; removing reference to "numbers only" reporting since there are no longer any conditions reportable by number only; added language noting all laboratories involved in testing are required to report results in order to prevent miscommunication between laboratories and ensure results are reported to public health; added requirement for reporting presumptive results for tuberculosis, Creutzfeldt-Jakob disease, and other transmissible human spongiform encephalopathies to ensure early identification of suspect cases of these diseases. Also, clarified that "rubella, congenital syndrome" is not immediately notifiable; added extensive guidance for laboratories that are reporting information electronically, including providing reference links to current guidelines, specifying required data elements and message structure, and providing information regarding reporting negative results for Chlamydia, Gonorrhea, Hepatitis A, B, and C, some HIV results, Salmonellosis, and TB; clarified that clinical material is required to be submitted, not just isolates, for conditions requiring submission of material to the UPHL; changes in laboratory tests are resulting in situations where no isolate results from testing, but clinical material is still appropriate to submit for confirmatory testing; modifying this language will enable UPHL to continue providing confirmatory testing and allows for submission of material for bacterial, viral, and other types of organisms as needed; added "measles (rubeola)" and "West Nile virus" to the list of organisms mandated for clinical submission since public health routinely asks for samples to confirm these conditions; added references to "patient encounter data" (as added in Subsection R386-702-3(2)) wherever "emergency illnesses or health conditions" are noted to guide reporting; and clarified language to provide specific clinical data elements required when reporting emergency conditions (i.e. changed "the reportable condition suspected" to "chief complaint(s), reason for visit, and/or diagnosis.") In Section R386-702-6, updated language to clarify the need for a 10-day quarantine of a healthy dog, cat, or ferret that bites a person, regardless of the animal's vaccination status. In Section R386-702-7, updated language to require contact precautions for diapered or incontinent persons, regardless of age, for the duration of the person's illness. This section establishes requirements for: reporting of screening, diagnostic, and treatment test results related to HIV/AIDS; partner identification and notification; and HIV/AIDS-related research. Information is being moved from Rule R388-803 and added as a new section in Title R386. Most of the information is the same as was previously included in Rule R388-803, though some formatting and organization of the information has been modified. In Section R386-702-10, added language: "Hospitals or birthing facilities shall report every instance of administration of HBIG to a newborn to the Utah Department of Health Immunization Program at 801-538-9450, and to the local health department, within seven days of administration." This was requested by the Immunization Program to ensure administration of HBIG is reported, improving their ability to identify and follow-up appropriately with these mothers and infants. Also, added language: "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." This should ensure pregnancy is identified and reported for all HBsAg positive women, for every pregnancy; corrected and clarified information for spacing of testing for infants born to HBsAg positive mothers; removed references to page numbers in "The Red Book Plus: 2009 Report of the Committee on Infectious Diseases" since these were incorrect page numbers; noting instead a reference to "the most current version of "The Red Book" as cited in Subsection R386-702-13(4)"; removed definitions of chronic and acute hepatitis B since inclusion is inconsistent when compared to other reportable conditions (definitions for specific conditions is included in individual disease plans); and added language: "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." This clarifies what is expected for investigation/action by LHDs for acute cases of hepatitis B. In Section R386-702-13, updated links and references as needed. Section R386-702-9 establishes requirements for: reporting of screening, diagnostic, and treatment test results related to HIV/AIDS; partner identification and notification; and HIV/AIDS-related research. Information is being moved from Rule R388-803 and added as a new section in Title R386. Most of the information is the same as was previously included in Rule R388-803, though some formatting and organization of the information has been modified. In Section R386-702-10, added language: "Hospitals or birthing facilities shall report every instance of administration of HBIG to a newborn to the Utah Department of Health Immunization Program at 801-538-9450, and to the local health department, within seven days of administration." This was requested by the Immunization Program to ensure administration of HBIG is reported, improving their ability to identify and follow-up appropriately with these mothers and infants. Also, added language: "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." This should ensure pregnancy is identified and reported for all HBsAg positive women, for every pregnancy; corrected and clarified information for spacing of testing for infants born to HBsAg positive mothers; removed references to page numbers in "The Red Book Plus: 2009 Report of the Committee on Infectious Diseases" since these were incorrect page numbers; noting instead a reference to "the most current version of "The Red Book" as cited in Subsection R386-702-13(4)"; removed definitions of chronic and acute hepatitis B since inclusion is inconsistent when compared to other reportable conditions (definitions for specific conditions is included in individual disease plans); and added language: "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." This clarifies what is expected for investigation/action by LHDs for acute cases of hepatitis B. In Section R386-702-13, updated links and references as needed.

State statutory or constitutional authorization for this rule:

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

Anticipated cost or savings to:

the state budget:

The majority of proposed changes provide clarifications to simplify interpretation of the rule and do not represent additional costs or savings. Adding anaplasmosis and leptospirosis to the reportable conditions list will result in minimal costs associated with management of those conditions since they are exceptionally rare; however, initially, personnel time will be needed to develop a disease plan and fact sheets for these conditions (approximately four hours for an epidemiologist). Adding mycobacteria other than tuberculosis should be cost-neutral since this reporting is already occurring; the change is formalizing this practice. Making Norovirus reportable for outbreaks only will result in significant savings in time since management of individual cases will no longer be required. Overall, changes in the reportable disease list will most likely be approximately cost-neutral. Facilitating electronic laboratory reporting will result in more laboratories providing information electronically, which will lead to more comprehensive disease reporting, and presumably more cases being reported due to the automated detection and reporting made possible through electronic laboratory reporting. There will be a need to work with local health departments to manage these cases, however, this is a key responsibility for public health, and efforts will be made to make this cost-neutral through automating procedures when possible and focusing resources on collecting the most critical data elements for each report. Clarifying that clinical material should be submitted to UPHL for confirmatory testing (vs. isolates) will cause additional samples to be submitted, though quantifying this change is challenging. The majority of conditions are rare, however enterics such as Campylobacter and Shigella are not uncommon conditions. These enterics typically have an isolate submitted, though, so the net change should be minimal, and enabling submission of clinical material should serve to accommodate changes in testing platforms that will enable continued confirmation regardless of initial testing platform. Adding rubeola (measles) and West Nile virus to the list of conditions requiring submission of a sample for confirmatory testing should be cost-neutral since this is already occurring; the change will formalize this practice. No changes were made to the content of the special measures for HIV/AIDS, so no costs will be associated with its move beyond approximately three hours of administrative time to update R388 once the change is enacted. Changes related to hepatitis B management are minimal; notifications and screenings should already be occurring, but formalizing it in rule may result in a small influx of notifications and reports to UDOH, which would require a small increase in the amount of time spent receiving and managing this information. However, this will be minimal and will serve to improve the catchment and management of perinatal hepatitis B in Utah.

local governments:

The main cost that may be incurred by local health departments is personnel time required to manage additional cases that may be detected and reported through electronic laboratory reporting, or through addition of anaplasmosis and leptospirosis to the list of reportable conditions. However, savings will accrue from making Norovirus reportable for outbreaks only, and efforts will be made to minimize costs associated with investigating cases through automating work when possible and focusing on collecting minimal information for only the most critical data elements. This should result in overall costs associated with the proposed changes being neutral.

small businesses:

Small clinics may incur some cost with the requirement to screen women age 12-50 years for pregnancy if they test positive for HBsAg, however, this screening should already be occurring so costs should be minimal. Likewise, reporting administration of HBIG should be occurring, but the change in its inclusion in rule may result in some costs for small facilities to identify and report this if they are not routinely doing so. Electronic laboratory reporting is optional, so the rule will not create a cost for small laboratories to implement electronic laboratory reporting unless they choose to do so. If they choose to implement this method of reporting, initial costs associated with programming systems to identify and report conditions to UDOH will be incurred, but it is anticipated that this will result in significant savings over time since reporting will be automated, requiring significantly less personnel time to manage.

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

As noted above, the main cost that may be incurred by Local Health Departments is personnel time required to manage additional cases that may be detected and reported through electronic laboratory reporting, or through addition of anaplasmosis and leptospirosis to the list of reportable conditions. However, savings will accrue from making Norovirus reportable for outbreaks only, and efforts will be made to minimize costs associated with investigating cases through automating work when possible and focusing on collecting minimal information for only the most critical data elements. This should result in overall costs associated with the proposed changes being neutral. Clinics may incur some cost with the requirement to screen women age 12 through 50 years for pregnancy if they test positive for HBsAg, however, this screening should already be occurring so costs should be minimal. Likewise, reporting administration of HBIG should be occurring, but the change in its inclusion in Rule may result in some costs for facilities to identify and report this if they are not routinely doing so. Electronic laboratory reporting is optional, so the Rule will not create a cost for laboratories to implement electronic laboratory reporting unless they choose to do so. If they choose to implement this method of reporting, initial costs associated with programming systems to identify and report conditions to UDOH will be incurred, but it is anticipated that this will result in significant savings over time since reporting will be automated, requiring significantly less personnel time to manage.

Compliance costs for affected persons:

There are no direct compliance costs associated with this amendment.

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

The fiscal impact on businesses is minimal. The new requirement to screen women ages 12-50 years for pregnancy if they test positive for HBsAG may have a minimum impact on business since this screening should already occur as a standard practice. The electronic laboratory reporting is optional and therefore will not create a cost for labs that choose not to participate.

David Patton, PhD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division 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 melissastevens@utah.gov

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:

11/14/2014

This rule may become effective on:

11/21/2014

Authorized by:

David Patton, Executive Director

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 [recent ]emergence of [new ]diseases, such as Human Immunodeficiency Virus, Hantavirus, and Severe Acute Respiratory Syndrome, and the rapid spread of diseases to the United States from other parts of the world, such as West Nile virus, 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 are defined in Section 26-6-2 and 26-23b-102, except that for purposes of this rule, "Department" means the Utah Department of Health.

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

(a) "Outbreak" means an [epidemic limited to a localized ]increase in incidence of disease, or two or more cases of disease with a common exposure.

(b) "Case" means a person identified as having a disease, health disorder, or condition that meets criteria for being[is] reportable under this rule, or that is otherwise under public health investigation.

(c) "Suspect["] case" means a person who a reporting entity, local health department, or 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.

 

R386-702-3. Reportable Diseases, Emergency Illnesses, and Health Conditions.

(1) The Utah Department of Health declares the following conditions to be of concern to [the ]public health and reportable as required or authorized by Section 26-6-6 and Title 26, Chapter 23b of the Utah Health Code.

(a) Acinetobacter species with resistance or intermediate resistance to carbapenems (specifically, meropenem and imipenem) from any anatomical site

(b) Acquired Immunodeficiency Syndrome

(c) Adverse event resulting [after]from smallpox vaccination

(d) Amebiasis

(e) Anaplasmosis

([e]f) Anthrax

([f]g) Arbovirus infection, including Saint Louis encephalitis and West Nile virus infection

([g]h) Babesiosis

([h]i) Botulism

([i]j) Brucellosis

([j]k) Campylobacteriosis

([k]l) Chancroid

([l]m) Chickenpox

([m]n) Chlamydia trachomatis infection

([n]o) Cholera

([o]p) Coccidioidomycosis

([p]q) Colorado tick fever

([q]r) Creutzfeldt-Jakob disease and other transmissible human spongiform encephalopathies

([r]s) Cryptosporidiosis

([s]t) Cyclospora infection

([t]u) Dengue fever

([u]v) Diphtheria

([v]w) Echinococcosis

([w]x) Ehrlichiosis, human granulocytic, human monocytic, or unspecified

([x]y) Encephalitis

([y]z)(1) Escherichia coli with resistance or intermediate resistance to carbapenems (meropenem, ertapenem, and imipenem) from any site

([y]z)(2) Shiga toxin-producing Escherichia coli (STEC) infection

([z]aa) Giardiasis

([aa]bb) Gonorrhea: sexually transmitted and ophthalmia neonatorum

([bb]cc) Haemophilus influenzae, invasive disease

([cc]dd) Hansen Disease (Leprosy)

([dd]ee) Hantavirus pulmonary syndrome

([ee]ff) Hemolytic Uremic Syndrome, postdiarrheal

([ff]gg) Hepatitis A

([gg]hh) Hepatitis B, acute, chronic, and perinatal[cases and carriers]

([hh]ii) Hepatitis C, acute and chronic infection

([ii]jj) Hepatitis, other viral

([jj]kk)(1) Human Immunodeficiency Virus Infection. [Reporting requirements are listed in R388-803.]Special measures for the control of HIV/AIDS are included in R386-702-9.

([jj]kk)(2) Pregnancy in a HIV case

([kk]ll) Influenza-associated hospitalization

([ll]mm) Influenza-associated death, in a person less than 18 years of age

([mm]nn) Klebsiella species with resistance or intermediate resistance to carbapenems (meropenem, ertapenem, and imipenem) from any site

([nn]oo) Legionellosis

(pp) Leptospirosis

([oo]qq) Listeriosis

([pp]rr) Lyme Disease

([qq]ss) Malaria

([rr]tt) Measles

([ss]uu) Meningitis (aseptic, bacterial, fungal, parasitic, protozoan, and viral)

([tt]vv) Meningococcal Disease

([uu]ww) Mumps

(xx) Mycobacteria other than tuberculosis

([vv]yy) Norovirus, [formerly called Norwalk-like virus, infection]outbreaks only

([ww]zz) Pertussis

([xx]aaa) Plague

([yy]bbb) Poliomyelitis, paralytic and nonparalytic

[(zz) Poliovirus infection, nonparalytic

] ([aaa]ccc) Psittacosis

([bbb]ddd) Q Fever (Coxiella infection)

([ccc]eee) Rabies, human and animal

([ddd]fff) Relapsing fever, tick-borne and louse-borne

([eee]ggg) Rubella , including congenital syndrome

[(fff) Rubella, congenital syndrome

]([ggg]hhh) Salmonellosis

([hhh]iii) Severe Acute Respiratory Syndrome (SARS)

([iii]jjj) Shigellosis

([jjj]kkk) Smallpox

([kkk]lll) Spotted fever rickettsioses (including Rocky Mountain Spotted Fever)

([lll]mmm) Staphylococcus aureus with resistance or intermediate resistance to vancomycin isolated from any site

([mmm]nnn) Streptococcal disease, invasive, including Streptococcus pneumoniae and Groups A, B, C, and G streptococci isolated from a normally sterile site

([nnn]ooo) Syphilis, all stages and congenital

([ooo]ppp) Tetanus

([ppp]qqq) Toxic-Shock Syndrome, [staphyloccal]staphylococcal or streptococcal

([qqq]rrr) Trichinellosis

([rrr]sss) Tuberculosis. Special Measures for the Control of Tuberculosis are listed in R388-804.

([sss]ttt) Tularemia

([ttt]uuu) Typhoid, cases and carriers

([uuu]vvv) Vibriosis

([vvv]www) Viral hemorrhagic fever

([www]xxx) Yellow fever

([xxx]yyy) Any unusual occurrence of infectious or communicable disease or any unusual or increased occurrence of any illness that may indicate a Bioterrorism event or public health hazard, including any single case or multiple cases of a newly recognized, emergent or re-emergent disease or disease-producing agent, including newly identified multi-drug resistant bacteria or a novel influenza strain such as a pandemic influenza strain.

([yyy]zzz) Any outbreak, epidemic, or unusual or increased occurrence of any illness that may indicate an outbreak or epidemic. This includes suspected or confirmed outbreaks of foodborne disease, waterborne disease, disease caused by antimicrobial resistant organisms, any infection that may indicate a bioterrorism event, or of any infection that may indicate a public health hazard.

(2) In addition to the reportable conditions set forth in R386-702-3(1) the Department declares the following reportable emergency illnesses, [or ]health conditions, and patient encounter information to be of [concern to the ]public health importance and reporting is authorized by Title 26, Chapter 23b, Utah Code, unless made mandatory by the declaration of a public health emergency:

(a) respiratory illness (including upper or lower respiratory tract infections, difficulty breathing and Adult Respiratory Distress Syndrome);

(b) gastrointestinal illness (including vomiting, diarrhea, abdominal pain, or any other gastrointestinal distress);

(c) influenza-like constitutional symptoms and signs;

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

(e) rash illness;

(f) hemorrhagic illness;

(g) botulism-like syndrome;

(h) lymphadenitis;

(i) sepsis or unexplained shock;

(j) febrile illness (illness with fever, chills or rigors);

(k) nontraumatic coma or sudden death;[ and]

(l) other criteria specified by the Department as indicative of disease outbreaks or injurious exposures of uncertain origin ; and

(m) patient encounter data including, but not limited to, chief complaint and discharge diagnosis data from healthcare settings which support early identification and ruling out of public health threats, disasters, disease outbreaks, suspected incidents, and acts of bioterrorism; assist in characterizing population groups at greatest risk for disease or injury; support assessment of the severity and magnitude of possible threats; or satisfy syndromic surveillance objectives of the Federal Centers for Medicaid and Medicare Meaningful Use incentive program.

 

R386-702-4. Reporting.

(1) Each reporting entity shall report each confirmed case and any case who the reporting entity believes , in its professional judgment , is likely to harbor an illness, infection, or condition reportable under R386-702-3(1), and each outbreak, epidemic, or unusual occurrence described in R386-702-3(1)([xxx]yyy) or ([yyy]zzz) to the local health department or to the Bureau of Epidemiology, Utah Department of Health. Unless otherwise specified, the report of these diseases to the local health department or to the Bureau of Epidemiology, Utah Department of Health shall provide the following information: name, age, sex, address, date of onset, and all other information as prescribed by the Department. A standard report form has been adopted and is supplied to physicians and other reporting entities by the Department. Upon receipt of a report, the local health department shall promptly forward a written or electronic copy of the report to the Bureau of Epidemiology, Utah Department of Health.

(2)(a) Where immediate reporting is required as noted in R386-702-4 (4), the reporting entity shall report as soon as possible, but not later than 24 hours after identification. Immediate reporting shall be made by telephone to the local health department or to the Bureau of Epidemiology, Utah Department of Health at 801-538-6191 or 888-EPI-UTAH (888-374-8824).

(b) All diseases not required to be reported immediately [or by number of cases ]shall be reported within three working days from the time of identification. Reporting entities shall send reports to the local health department by phone, secured fax, secured email, or mail; or to the Bureau of Epidemiology by phone (801-538-6191), secured fax (801-538-9923), secured email (please contact the Bureau of Epidemiology at 801-538-6191 for information on this option), or by mail (288 North 1460 West, P. O. Box 142104, Salt Lake City, Utah 84114-2104).

(c) Laboratories [may]are encouraged to report case information electronically in a manner approved of by the Department if the laboratory has the capacity to do so. Laboratories should refer to https://health.utah.gov/phaccess/public/elr/ for information about this option. [(p]Please contact the Bureau of Epidemiology at 801-538-6191 for questions[information on] regarding this option[)].

(d) When more than one licensed laboratory is involved in testing a specimen, all laboratories involved are required to report results.

(e) The following requirements apply to laboratories that are reporting information electronically:

(i) Laboratories reporting electronically shall send the following information with all reports:

(1) First and last name of the patient;

(2) Patient date of birth;

(3) Patient hospitalization status;

(4) Name and telephone number of the reporting facility;

(5) Name and telephone number of the testing laboratory;

(6) Patient address

(7) Name and address of the requesting health care provider;

(8) Pregnancy status;

(9) Specimen source;

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

(11) Test reference range; and

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

(ii) Laboratories reporting electronically shall use HL7 2.3.1 or 2.5.1 message structure for all fields and appropriate LOINC codes designating the test performed.

(iii) Laboratories reporting electronically shall submit all local vocabulary codes with translations to UDOH, if applicable.

(iv) Laboratories reporting electronically must send reports within 24 hours of finalization of test results.

(v) Laboratories reporting electronically must report preliminary positive results for immediately notifiable conditions as specified in R386-702-4 (4).

(vi) Electronic reporting of negative results:

(1) Electronic reporting shall include negative as well as positive results for tests ordered for the following conditions:

(a) Chlamydia

(b) Gonorrhea

(c) Hepatitis A

(d) Hepatitis B

(e) Hepatitis C, including viral loads

(f) Human Immunodeficiency Virus (HIV), including viral loads and confirmatory tests

(g) Salmonellosis

(h) STEC

(i) Tuberculosis

(2) Negative test results reported for these conditions will be used for the following purposes as authorized in Utah Health Code Section 26-1-30(2)(c),(d), and (f):

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

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

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

(3) Information associated with a negative test result will be retained by the Utah Department of Health for a period of 18 months.

(a) 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.

(b) The de-identified result will be added to a de-identified, aggregate dataset which will be retained for use by public health to analyze trends associated with testing patterns and case distribution, enabling identification and establishment of prevention and intervention efforts for at-risk populations, and assessment of trends over time in those populations, as authorized by Utah Health Code 26-1-30(2)(f).

(3) Entities Required to Report Communicable Diseases: Title 26, Chapter 6, Section 6 Utah Code lists those individuals and facilities required to report diseases known or suspected of being communicable.

(a) Physicians, hospitals, health care facilities, home health agencies, health maintenance organizations, and other health care providers shall report details regarding each case.

(b) Schools, child care centers, and citizens shall provide any relevant information.

(c) Laboratories and other testing sites shall report laboratory evidence confirming any of the reportable diseases. Laboratories and other testing sites shall also report any test results that provide presumptive evidence of infection, which may include[such as] positive tests for HIV, syphilis, measles, [and ]viral hepatitis , tuberculosis, and Creutzfeldt-Jakob disease and other transmissible human spongiform encephalopathies.

(i) Detailed lists of reportable laboratory events, e.g. laboratory tests and results that signify a reportable condition, are found at: https://health.utah.gov/phaccess/public/elr/; click on " Spreadsheet of Reportable Events and Vocabulary" to access this list.

(ii) Events noted within the "Spreadsheet of Reportable Events and Vocabulary" constitute those that are reportable according to this Rule, and as such are considered mandatory for laboratories to report.

(iii) The "Spreadsheet of Reportable Events and Vocabulary" defines, for laboratory reporting purposes, those unusual occurrences of conditions as noted in R386-702-3 (1)(yyy) and (zzz).

(d) Pharmacists shall report unusual prescriptions or patterns of prescribing as specified in section 26-23b-105.

(4) Immediately Reportable Conditions: Case[s] and suspect case[s] reports of anthrax, botulism (except for infant botulism), cholera, diphtheria, Haemophilus influenzae (invasive disease), hepatitis A, measles, meningococcal disease, plague, poliomyelitis, rabies, rubella (excluding congenital syndrome), Severe Acute Respiratory Syndrome (SARS), smallpox, Staphylococcus aureus with resistance (VRSA) or intermediate resistance (VISA) to vancomycin isolated from any site, tuberculosis, tularemia, typhoid, viral hemorrhagic fever, yellow fever, and any condition described in R386-702-3(1)([ xxx]yyy) or ([yyy]zzz) are to be made immediately as provided in R386-702-4(2).

(5) Mandatory Submission of Clinical Material:

(a) Laboratories shall submit clinical material from all cases identified with organisms listed in (5)(c) below to the Utah Department of Health, Utah Public Health Laboratory (UPHL). Clinical material is defined as:

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

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

(A) a patient specimen;

(B) nucleic acid; or

(C) other laboratory material.

(b) Laboratories should alert UPHL via telephone during business hours at (801) 965-2400, or after hours at (801) 560-6586, of all bioterrorism (BT) agents that are being submitted. BT agents are marked below (as (BT)) with other organisms mandated for submission.

(c) Organisms that are mandated for clinical submission in Utah include:

(i) Bacillus anthracis (BT);

(ii) Brucella species (BT);

(iii) Campylobacter species;

(iv) Clostridium botulinum (BT);

(v) Corynebacterium diphtheriae;

(vi) Shiga toxin-producing Escherichia coli (STEC) (including enrichment and/or MacConkey broths that tested positive by enzyme immunoassay for Shiga toxin);

(vii) Francisella tularensis (BT);

(viii) Haemophilus influenzae, from normally sterile sites;

(ix) Influenza virus (hospitalized cases only);

(x) Legionella species;

(xi) Listeria monocytogenes;

(xii) Measles (rubeola);

(xiii) Mycobacterium tuberculosis complex;

(xiv) Neisseria gonorrhoeae;

(xv) Neisseria meningitidis, from normally sterile sites;

(xvi) Salmonella species;

(xvii) Shigella species;

(xviii) Staphylococcus aureus with resistance or intermediate resistance to vancomycin isolated from any site;

(xix) Vibrio species;

(xx) West Nile virus;

(xxi) Yersinia species (Yersinia pestis, BT); and

(xxii) any organism implicated in an outbreak when instructed by authorized local or state health department personnel.

([5]6) Full reporting of all relevant patient information related to laboratory-confirmed influenza is authorized and may be required by local or state health department personnel for purposes of public health investigation of a documented threat to public health.

([6]7) Reports of emergency illnesses, [or ]health conditions, and patient encounter information under R386-702-3(2) shall be made as soon as practicable using a process and schedule approved by the Department. Full reporting of all relevant patient information is authorized. The report shall include at least, if known:

(a) name of the facility;

(b) a patient identifier;

(c) date of visit;

(d) time of visit;

(e) patient's age;

(f) patient's sex;

(g) zip code of patient's residence;

(h) [the reportable condition suspected]chief complaint(s), reason for visit, and/or diagnosis; and

(i) whether the patient was admitted to the hospital.

([7]8) An entity reporting emergency illnesses,[or] health conditions, and patient encounter information under R386-702-3(2) is authorized to report on other encounters during the same time period that do not meet definition for a reportable emergency illness, [or ]health condition, or patient encounter. Submission of an isolate does not replace the requirement to report the case also to the local health department or Bureau of Epidemiology, Utah Department of Health. The report shall include the following information for each such encounter:

(a) facility name;

(b) date of visit;

(c) time of visit;

(d) patient's age;

(e) patient's sex; and

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

[(8) Mandatory Submission of Isolates: Laboratories shall submit all isolates of the following organisms to the Utah Department of Health, public health laboratory. Laboratories should alert the Unified State Laboratories: Public Health (USLPH), via telephone during business hours (801) 965-2560 or after hours (888) EPI-UTAH, on all bioterrorism (BT) agents that are being submitted. BT agents are marked below (as (BT)) with other organisms mandated for submission:

(a) Bacillus anthracis (BT);

(b) Brucella species (BT);

(c) Campylobacter species;

(d) Clostridium botulinum (BT);

(e) Corynebacterium diphtheriae;

(f) Shiga toxin-producing Escherichia coli (STEC) (including enrichment and/or MacConkey broths that tested positive by enzyme immunoassay for Shiga toxin);

(g) Francisella tularensis (BT);

(h) Haemophilus influenzae, from normally sterile sites;

(i) Influenza (hospitalized cases only), types A and B;

(j) Legionella species;

(k) Listeria monocytogenes;

(l) Mycobacterium tuberculosis complex;

(m) Neisseria gonorrhoeae;

(n) Neisseria meningitidis, from normally sterile sites;

(o) Salmonella species;

(p) Shigella species;

(q) Staphylococcus aureus with resistance or intermediate resistance to vancomycin isolated from any site;

(r) Vibrio species;

(s) Yersinia species (Yersinia pestis, BT); and

(t) any organism implicated in an outbreak when instructed by authorized local or state health department personnel.

](9) Epidemiological Review: The Department or local health department may conduct an investigation, including review of the hospital and health care facility medical records and contacting the individual patient to protect the public's health.

(10) Confidentiality of Reports: All reports required by this rule are confidential and are not open to public inspection. Nothing in this rule, however, precludes the discussion of case information with the attending physician or public health workers. All information collected pursuant to this rule may 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.

(11) If public health conducts a retrospective surveillance project, such as to assess completeness of case finding or assess another measure of data quality, the department may, at its discretion, waive any penalties for participating facilities, medical providers, laboratories, or other reporters if cases are found that were not originally reported for whatever reason.

 

R386-702-5. 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 R386-702-12.

(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.

 

R386-702-6. 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(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(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(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 180 days. 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.

(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 six months and 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(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(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) 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 R386-702-12(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 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 R386-702-12(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.

(4) 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.

 

R386-702-7. 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 [children under 6 years of age]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(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(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. 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(4)(a) or R386-702-7(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(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(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;

(c) Supervise 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.

 

R386-702-8. 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.

 

R386-702-9. Special Measures for the Control of HIV/AIDS.

(1) Authority for this section is established by Title 26, Chapter 6, Sections 3 and 3.5 of the Utah Communicable Disease Control Act. This section establishes requirements for:

(a) General reporting of screening, diagnostic, and treatment test results related to Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS).

(b) Partner identification and notification.

(2) Reporting of HIV and AIDS:(a) A health care provider who administers or causes to have administered any of the following tests shall report all positive and indeterminate results (preliminary and confirmatory) to the Department or the local health department:

(i) Presence of antibodies to HIV;

(ii) Presence of HIV antigen;

(iii) Isolation of HIV;

(iv) Demonstration of HIV pro-viral DNA;

(v) Demonstration of HIV specific nucleic acids;

(vi) HIV viral load determination;

(vii) Any other test or condition indicative of HIV infection; and

(viii) CD4+ T-Lymphocyte tests, regardless of known HIV status.

(b) A laboratory that analyzes samples for any of the tests listed in R386-702-9(2)(a) shall report all results to the Department or the local health department.

(i) Specific electronic reporting requirements are described in R386-702-4(2)(e).

(c) Reports shall include, as available:

(i) First and last name of the patient;

(ii) Patient date of birth;

(iii) Sex;

(iv) Race;

(v) Occupation;

(vi) Patient phone number;

(vii) Patient hospitalization status;

(viii) Name and telephone number of the reporting facility;

(ix) Name and telephone number of the testing laboratory;

(x) Patient home and work address;

(xi) Name, address, and phone number of the requesting health care provider;

(xii) Specimen source;

(xiii) Laboratory's name for, or description of, the test;

(xiv) Test reference range; and

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

(d) Reports may be made in writing, by telephone, or by other electronic means acceptable to the Department as described in R386-702-4(2).

(3) Partner identification and notification: 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.

(a) Definitions:

(i) "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.

(ii) "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.

(iii) "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.

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

(b) Partner services include:

(i) Confidential partner notification within 30 days of receiving a positive HIV result;

(ii) Prevention counseling;

(iii) Testing for HIV;

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

(v) Providing recommendations for hepatitis screening and vaccination;

(iv) Treatment or linkage to medical care within three months of HIV diagnosis; and

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

(4) A university or hospital that conducts research studies exempt from reporting AIDS and HIV infection under Section 26-6-3.5 shall submit the following to the Department:

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

(b) Written approval of the Utah Department of Health institutional review board; and

(c) A final report indicating the number of HIV positive and HIV negative individuals enrolled in the study.

 

R386-702-[9]10. 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 should 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;

(c) occurrence during pregnancy or a history of a sexually transmitted disease;

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

(e) the judg[e]ment 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 Utah Department of Health, 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 H[ b] BsAg 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, or whose status is unknown, 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.

([a]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)[ Table 3.18, page 328 and Table 3.21, page 333 of the reference listed in subsection (9)].

([b]c) Children born to HBsAg positive mothers are tested for HBsAg and antibody against hepatitis B surface antigen (anti-HBs) at 9 to 1[5]8 months of age (testing is done at least one month[3-9 months] after the [third]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 ([b]c) receive additional vaccine doses and are retested as specified [on page 332 of the reference listed in subsection (9)]in the most current version of "The Red Book" as cited in R386-702-13 (4).

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

([d]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.

(f) 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) An individual with chronic hepatitis B infection is defined as an individual who is:

(i) HBsAg positive, and total antibody against hepatitis B core antigen (anti-HBc) positive (if done) and IgM anti-HBc negative; or

(ii) HBsAg positive on two tests performed on serum samples obtained at least 6 months apart.

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

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

[(9) The Red Book Plus: 2009 Report of the Committee on Infectious Diseases, as referenced in R386-702-12(4) is the reference source for details regarding implementation of the requirements of this section.

]

R386-702-1[0]1. 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 Title 26, Chapter 21, Utah Code, 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.

(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;

(c) time 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.

 

R386-702-1[1]2. Penalties.

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

 

R386-702-1[2]3. 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". 19th ed., Heymann, David L., editor, 2008.

(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):[; 57 (RR03): ]1-26, 28.

(3) [The ]National Association of State Public Health Veterinarians Committee[, Inc].[,] "Compendium of Animal Rabies Prevention and Control, 2011." Nasphv.org. National Association of State Public Health Veterinarians, 31 May 2011. Web. http://nasphv.org/Documents/RabiesCompendium.pdf

(4) American Academy of Pediatrics. "Red Book: 2012 Report of the Committee on Infectious Diseases" 29th Edition. Elk Grove Village, IL, American Academy of Pediatrics; 2012.

(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, quarantine, rabies, rules and procedures

Date of Enactment or Last Substantive Amendment: [May 15, 2013]2014

Notice of Continuation: October 12, 2011

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