Amended Notice of Intended Action

Human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS), ch 11

Untitled document

ARC 8191C

PUBLIC HEALTH DEPARTMENT[641]

Amended Notice of Intended Action

Proposing rulemaking related to HIV and AIDS
and providing an opportunity for public comment

The Department of Health and Human Services (HHS) hereby proposes to rescind Chapter 11, “Human Immunodeficiency Virus (HIV) Infection and Acquired Immune Deficiency Syndrome (AIDS),” Iowa Administrative Code, and to adopt a new chapter with the same title.

Legal Authority for Rulemaking

This rulemaking is proposed under the authority provided in Iowa Code chapters 135, 139A, 141A and 915.

State or Federal Law Implemented

This rulemaking implements, in whole or in part, Iowa Code sections 135.11(20), 135.11(22), 139A.19, 139A.33 and 141A.5(2)“c” and the Public Health Service (PHS) Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009.

Purpose and Summary

Proposed Chapter 11 describes HHS procedures and programs related to HIV and AIDS. This includes reporting of new diagnoses, protocols concerning individuals voluntarily seeking testing, procedures when a health care worker has an occupational exposure, reporting requirements should a positive test be confirmed, and notification and testing requirements when a third party is found to have been exposed.

These rules additionally implement HIV-related training programs and set procedures for eligibility and enrollment in the Ryan White Program. The Ryan White Program is a federally designated program that supports eligible low-income Iowans living with HIV/AIDS with medical and support services and assistance with the cost of medication and health insurance. Under federal legislation, it is the payer of last resort for HIV-related services. The Ryan White Program is not an entitlement program and does not create a right to assistance.

The procedures and programs described in this chapter are designed to provide appropriate individual- and community-level protections related to an HIV/AIDS diagnosis. They also provide for access to health care services for people diagnosed and living with HIV/AIDS in Iowa.

Reason for Amendment of Notice of Intended Action

NoticeofIntendedActionforthisrulemaking was published in the Iowa Administrative Bulletin on January 24, 2024, asARC7371C.Based on further public comment that was received after the publication of the Notice, some changes from the Notice have been made. Specifically, the sections on care provider notification were changed to allow a medical provider to wait until after testing has been performed to notify a source patient that an occupational exposure occurred and that the source patient was tested for the presence of blood-borne pathogens. This change was made to accommodate situations in which the source patient may be incapacitated or when it may be otherwise impractical for the medical provider to notify the source patient prior to the testing.

Fiscal Impact

This rulemaking has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rulemaking, no impact on jobs has been found.

Waivers

Any person who believes that the application of the discretionary provisions of this rulemaking would result in hardship or injustice to that person may petition HHS for a waiver of the discretionary provisions, if any, pursuant to 441—Chapter 6.

Public Comment

Any interested person may submit written comments concerning this proposed rulemaking. Written comments in response to this rulemaking must be received by HHS no later than 4:30 p.m. on September 5, 2024. Comments should be directed to:

Joe Campos
Lucas State Office Building
321 East 12th Street
Des Moines, Iowa 50319
Email: compliancerules@idph.iowa.gov

Public Hearing

Public hearings at which persons may present their views orally or in writing will be held as follows:

September 3, 2024
12 noon to 12:30 p.m.

Microsoft Teams
Meeting ID: 268 032 249 828
Passcode: xGDP9t

September 5, 2024
2 to 2:30 p.m.

Microsoft Teams
Meeting ID: 220 612 072 487
Passcode: vTNDrz

Persons who wish to make oral comments at a public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rulemaking.

Any persons who intend to attend a public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact HHS and advise of specific needs.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rulemaking at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

The following rulemaking action is proposed:

ITEM 1.Rescind 641—Chapter 11 and adopt the following new chapter in lieu thereof:

CHAPTER 11

HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)

641—11.1(139A,141A) Definitions.

“AIDS” means the same as defined in Iowa Code section 141A.1.

“AIDS-related condition” means the same as defined in Iowa Code section 141A.1.

“Alleged offender” means the same as defined in Iowa Code section 915.40.

“Benefits and drug assistance program” or “BDAP” means the Iowa benefits and drug assistance program, a component of the Ryan White program administered by the health and human services department (department).

“Blood bank” means a facility for the collection, processing, or storage of human blood or blood derivatives, or from which or by means of which human blood or blood derivatives are distributed or otherwise made available.

“Blood-borne viral hepatitis” means hepatitis B or hepatitis C.

“Care provider” means the same as defined in Iowa Code section 139A.2.

“CDC” means the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.

“Certification of a significant exposure report” means the determination by an authorized infection preventionist, occupational health professional, or other personnel trained in infection control or infectious disease medicine and designated by a facility to review significant exposure reports that the incident described by the exposed care provider meets the definition of a significant exposure as defined in this rule.

“Confirmed positive test” means a reactive result or detectable quantity on any HIV-related test, including an antibody test, an antigen test, a culture, a nucleic acid amplification test, or other test or combination of tests that is considered to be confirmatory according to prevailing medical technology and algorithms or guidance from CDC. When the confirmed positive test involves more than one test, all test results should be included in any reports to the department.

“Contagious or infectious disease” means hepatitis in any form, meningococcal disease as defined in these rules, AIDS or HIV as defined in Iowa Code section 141A.1, tuberculosis as defined in these rules, and any other disease determined to be life-threatening to a person exposed to the disease based upon a determination by the state epidemiologist or medical director and in accordance with guidelines of the CDC.

“Department of corrections” means the Iowa department of corrections.

“Designated representative” means a person who is designated by a department, agency, division, or service organization to act on behalf of the exposed care provider as a liaison with the facility that received the source patient when the exposure occurred in the field or during patient transport.

“Director of a plasma center, blood bank, clinical laboratory, organ procurement organization, or public health laboratory” means the person responsible for direction and operation of the facility, the medical director, or the person designated by the director or medical director to ensure compliance with applicable regulations and requirements.

“Emergency medical services personnel” means “emergency medical care provider” as defined in Iowa Code section 147A.1.

“Exposure” means the same as defined in Iowa Code section 139A.2.

“HBV” means hepatitis B virus.

“Health care facility” means the same as defined in Iowa Code section 139A.2.

“Health care provider” means the same as defined in Iowa Code section 141A.1.

“Health facility” means the same as defined in Iowa Code section 141A.1.

“HIV” means the same as defined in Iowa Code section 141A.1.

“HIV infection” means having acquired the human immunodeficiency virus.

“HIV-related test” means the same as defined in Iowa Code section 141A.1.

“Home health services” means health care services provided by a care provider in a patient’s home or other residence.

“Identifiable third party” means a sexual partner of or a person who shares drug injecting equipment with a person who has been diagnosed with HIV infection.

“Infectious bodily fluids” means bodily fluids capable of transmitting HIV as listed in “Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis,” dated September 25, 2013, and updated May 23, 2018, published by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia 30333, on its website. To prevent HIV and blood-borne viral hepatitis disease transmission, this reference indicates that standard precautions should be followed for exposure to the following infectious bodily fluids: blood, amniotic fluid, pericardial fluid, peritoneal fluid, pleural fluid, synovial fluid, cerebrospinal fluid, semen, vaginal secretions, and saliva contaminated with blood. HIV and blood-borne viral hepatitis disease transmission has not occurred from feces, nasal secretions, sputum, sweat, tears, urine, vomitus, and saliva when it is not contaminated with blood.

“Laboratory” means a clinical or public health laboratory, a plasma center, or a blood bank inside or outside the boundaries of Iowa.

“Meningococcal disease” means acute infectious bacterial meningococcal infection presenting as invasive disease characterized by one or more clinical syndromes, including bacteremia, sepsis, or meningitis. “Meningococcal disease” does not include nasopharyngeal colonization by Neisseria meningitidis.

“Payer of last resort” means a requirement to coordinate services and seek payment from all other sources before Ryan White program funds are used.

“Physician” means a person currently licensed pursuant to Iowa Code chapter 148.

“Physician assistant” means a person currently licensed under Iowa Code chapter 148C.

“Plasma center” means a facility that conducts plasmapheresis.

“Plasmapheresis” means the removal of blood from a human being to obtain plasma with the subsequent reinfusion of the remaining formed elements into the donor but excludes such a procedure performed for the purpose of improving the health of the donor.

“Public health laboratory” means a laboratory operated by an agency of city, county or state government for the purpose of supporting disease control activities.

“Respite care services” means health care services provided by a care provider in a patient’s home or other residence on a short-term, temporary basis as relief to those who are caring for family members.

“Ryan White program” means the Ryan White part B program administered by the department, which provides case management, behavioral health, and other supportive services, and assistance with the costs of housing, health insurance, and treatment medications for eligible low-income individuals diagnosed with HIV.

“Sexually transmitted disease or infection” means “sexually transmitted disease or infection” as defined in rule 641—1.1(139A).

“Significant exposure” means a situation in which there is a risk of contracting disease through exposure to a patient’s infectious bodily fluids in a manner capable of transmitting an infectious agent as determined by CDC. Exposure includes contact with blood or other infectious bodily fluids to which standard precautions apply through percutaneous inoculation or contact with an open wound, nonintact skin, or mucous membranes during the performance of normal job duties. Significant exposures include:

1.Transmission of blood, bloody fluids, or other infectious bodily fluids of the source patient onto a mucous membrane (mouth, nose, or eyes) of the care provider.

2.Transmission of blood, bloody fluids, or other infectious bodily fluids of the source patient onto an open wound or lesion with significant breakdown in the skin barrier, including a needle puncture with a needle contaminated with blood, bloody fluids, or other infectious bodily fluids.

“Significant exposure report” means the Report of Exposure to HIV or Other Infectious Disease form provided by the department. This is the only form authorized to be used to document a significant exposure to infectious bodily fluids such that the source patient is deemed to consent to a test to determine if the patient has a contagious or infectious disease and is deemed to consent to notification of the care provider of the results of the test pursuant to Iowa Code section 139A.19.

“Tuberculosis” means infectious tuberculosis as defined in rule 641—1.1(139A).

641—11.2(141A) HIV testing—obtaining consent—voluntary HIV-related tests for adults who are not pregnant.

11.2(1) Prior to conducting a voluntary HIV-related test on an adult, the health care provider requesting the test shall provide information to the subject of the test concerning HIV testing and where to obtain additional information regarding HIV infection and risk reduction.

11.2(2) Patient consent for testing must be obtained as detailed in Iowa Code section 141A.6.

11.2(3) Once an adult has been informed of a confirmed positive HIV-related test, no HIV-specific consent for medical procedures and tests shall be required for subsequent medical procedures and tests involved in the care or treatment of the adult with HIV infection.

641—11.3(139A,141A) HIV testing—obtaining consent—voluntary HIV-related tests for minors who are not pregnant.

11.3(1) Patient consent for testing must be obtained as detailed in Iowa Code section 141A.6. A minor shall have the legal capacity to act and give consent pursuant to Iowa Code section 139A.35.

11.3(2) Prior to conducting a voluntary HIV-related test on a minor, the health care provider requesting the test shall provide information to the subject of the test concerning HIV testing and where to obtain additional information regarding HIV infection and risk reduction.

11.3(3) A minor shall be informed prior to testing of requirements for health facilities to inform the minor’s legal guardian of a positive test result pursuant to Iowa Code section 141A.7.

11.3(4) Prior to the test, a minor shall give written consent for performance of the HIV-related test and to the notification of the legal guardian should the test be confirmed as positive.

11.3(5) Once a minor has been informed of a confirmed positive HIV-related test and the legal guardian has been notified, no HIV-specific consent for medical procedures and tests shall be required for subsequent medical procedures and tests involved in the care or treatment of a minor with HIV infection.

641—11.4(141A) HIV testing—obtaining consent—voluntary HIV-related tests for pregnant women.

11.4(1) Health care providers that offer prenatal care to women shall provide HIV testing to all pregnant women as described in Iowa Code section 141A.4. No written or oral consent shall be required.

11.4(2) The testing shall occur as early as possible during each pregnancy.

11.4(3) The health care provider requesting the test shall make information available about HIV prevention, risk reduction, and treatment to all pregnant women pursuant to Iowa Code section 141A.4.

11.4(4) A pregnant woman who is a minor shall be informed prior to testing of requirements for health facilities to inform the minor’s legal guardian of a positive test result as described in Iowa Code section 141A.7.

11.4(5) If a pregnant woman declines the test, the decision shall be documented as described in Iowa Code section 141A.4. A health care provider shall encourage women who decline the test early in prenatal care to be tested at a subsequent visit.

11.4(6) Once a pregnant woman has been informed of a confirmed positive HIV-related test and, if the pregnant woman is a minor, the legal guardian has been notified, no HIV-specific consent for medical procedures and tests shall be required for subsequent medical procedures and tests involved in the care or treatment of a pregnant woman with HIV infection.

641—11.5(141A) HIV test results—posttest counseling. Upon informing the subject of an HIV-related test of a confirmed positive test result, the health care provider who requested the test or other designated personnel shall initiate counseling concerning the emotional and physical health effects of HIV infection as described in Iowa Code section 141A.7.

641—11.6(141A) Reporting of diagnoses and HIV-related tests, events, and conditions to the department.

11.6(1) The following constitute reportable events related to HIV infection:

a.A test result indicating HIV infection, including:

(1)Confirmed positive results on any HIV-related test or combination of tests, including antibody tests, antigen tests, cultures, and nucleic acid amplification tests.

(2)A positive result or report of a detectable quantity on any other HIV detection (non-antibody) tests, and results of all viral loads, including nondetectable levels.

(3)Results of genotypic resistance assays.

b.AIDS and AIDS-related conditions, including all levels of CD4+ T-lymphocyte counts.

c.Birth of an infant to an HIV-infected mother (perinatal exposure) or any (positive, negative, or undetectable) non-antibody detection test (antigen test, viral culture, viral load, or qualitative nucleic acid amplification test) on an infant 18 months of age or younger.

d.Death resulting from an AIDS-related condition or death of a person with HIV infection.

11.6(2) Reportable events as described in this rule shall be reported to the department pursuant to Iowa Code section 141A.6. The following reporting requirements are in addition to those described in Iowa Code section 141A.6.

a.Within seven days of the receipt of a person’s confirmed positive test result indicating HIV infection, the director of a plasma center, organ procurement organization, or public health laboratory that performed the test or that requested the confirmatory test shall make a report to the department.

b.Within seven days of the birth of an infant to a mother diagnosed with HIV or a receipt of a laboratory result (positive, negative, or undetectable) of a non-antibody detection test (antigen test, viral culture, viral load, or qualitative nucleic acid amplification test) on an infant 18 months of age or younger, the attending physician shall make a report to the department.

11.6(3) The report shall be made on a form provided by the department that includes those form fields described in Iowa Code section 141A.6 unless approval from the department has been obtained for use of other reporting formats.

11.6(4) All persons who experience a reportable event while receiving services in the state, regardless of state of residence, shall be reported.

Rules 641—11.1(139A,141A) through 641—11.6(141A) are intended to implement Iowa Code sections 139A.35, 141A.4, 141A.6, and 141A.7.

641—11.7(141A) Confidentiality of information. In addition to the entities described in Iowa Code section 141A.9, medical information secured pursuant to Iowa Code section 141A.9(1) may be shared between employees and agents of the department and employees and agents of tribes and tribal public health authorities that have a need for the information in the duties related to HIV prevention, disease surveillance, or care of persons with HIV, only as necessary to administer the program for which the information is collected or to administer a program in the tribe or tribal public health authority. Confidential information transferred to other persons or entities under this rule shall continue to maintain its confidential status as described in Iowa Code section 141A.9.

This rule is intended to implement Iowa Code section 141A.9.

641—11.8(135) HIV and AIDS training programs where occupational exposure to blood or other potentially infectious materials may occur.

11.8(1) Personnel covered by the rule.

a.Nonemergency personnel. All supervisory and patient care personnel of any agency listed below:

(1)A licensed hospice,

(2)A homemaker-home health aide provider agency that receives state homemaker-home health aide funds, or

(3)An agency that provides respite care services.

b.Emergency and law enforcement personnel. All personnel from the following agencies:

(1)Emergency medical services.

(2)Fire services.

(3)Law enforcement.

11.8(2) Topics covered. Training programs must address the following topics, consistent with standards from the Occupational Safety and Health Administration of the U.S. Department of Labor:

a.Symptoms and modes of transmission of blood-borne diseases, including human immunodeficiency virus and viral hepatitis,

b.Location and handling of personal protective equipment,

c.Information on the hepatitis B vaccine, and

d.Follow-up procedures in the event of an exposure.

11.8(3) Timing of training. Training must occur before an initial assignment of tasks where occupational exposure to blood or other potentially infectious materials may take place and at least annually thereafter.

This rule is intended to implement Iowa Code section 135.11.

641—11.9(139A,141A) Partner notification program.

11.9(1) The department will maintain a partner notification program for persons known to have tested positive for sexually transmitted diseases or infections pursuant to the procedures described in Iowa Code sections 141A.5 and 139A.33.

11.9(2) Services provided include but are not limited to counseling about the disease or infection, risk reduction techniques, linkage to medical care and treatment, assessment and referral to social and prevention services, and elicitation of exposed partners’ names and contact information for referral to testing, as described in the Partner Services Program Manual dated December 2023, adopted and incorporated by this reference. The manual contains the policies and procedures utilized in the implementation of the program. The manual is updated annually. A copy of the manual is available on the department website.

11.9(3) The department may delegate its partner notification duties under this rule for persons who have tested positive for HIV or other sexually transmitted diseases to a local health authority or a physician or other health care provider unless the authority or physician or other health care provider refuses or neglects to conduct the partner notification program in a manner deemed to be effective by the department.

641—11.10(141A) Direct notification of an identifiable third party by a physician, physician assistant or the department.

11.10(1) Direct notification shall be used when a person diagnosed with HIV is having continuing contact with a sexual or needle-sharing partner who is unaware of the person’s infection and when both of the following situations exist:

a.A physician or physician assistant for the person diagnosed with HIV is of the good-faith opinion that the nature of the continuing contact through sexual intercourse or the sharing of drug injecting equipment poses an imminent danger of HIV transmission to the third party.

b.When the physician or physician assistant believes in good faith that the person diagnosed with HIV, despite strong encouragement, has not and will not warn the third party and will not participate in the voluntary partner notification program.

11.10(2) The department or a physician or a physician assistant may reveal the identity of a person diagnosed with HIV pursuant to this rule only to the extent necessary to protect a third party from the direct threat of transmission. Notification of a person pursuant to this rule shall be made confidentially. Nothing in this rule shall be interpreted to create a duty to warn third parties of the danger of exposure to HIV through contact with a person diagnosed with HIV.

11.10(3) When the physician or physician assistant is of the good-faith opinion and belief that third-party notification should be performed, notification of a person pursuant to this rule shall be made:

a.Directly by the physician or physician assistant, or

b.By the department at the request of the physician or physician assistant.

11.10(4) Notification by the physician or physician assistant. Prior to notification of a third party by the physician or physician assistant of a person diagnosed with HIV, the physician or physician assistant shall make reasonable efforts to inform, in writing, the person diagnosed with HIV. The written information shall state that, due to the nature of the person’s continuing contact through sexual intercourse or the sharing of drug injecting equipment with the third party and the physician’s or physician assistant’s belief that the person diagnosed with HIV, despite strong encouragement, has not and will not warn the third party and will not participate in the voluntary partner notification program, the physician or physician assistant is forced to take action to provide notification to the third party. The physician or physician assistant, when reasonably possible, shall provide the following information to the person diagnosed with HIV:

a.The nature of the disclosure and the reason for the disclosure.

b.The anticipated date of disclosure.

c.The name of the party or parties to whom disclosure is to be made.

NOTE: Reasonable efforts to inform, in writing, the person diagnosed with HIV shall be deemed satisfied when the physician or physician assistant delivers the written notice in person or directs a written notice to the diagnosed person’s last-known address by restricted certified mail, return receipt requested, at least five days prior to the anticipated date of disclosure to the third party.

11.10(5) When performed by the diagnosed person’s physician or physician assistant, notification of the third party and any disclosure concerning the purpose of that notification shall be made in person. However, initial contact with the third party may be made by telephone, mail, or other electronic means to arrange the meeting with the physician or physician assistant at the earliest opportunity to discuss an important health matter. The nature of the health matter to be discussed shall not be revealed in the telephone call, letter, or other electronic message.

11.10(6) Notification by the department.

a.The physician or physician assistant attending the person diagnosed with HIV shall provide by telephone to the department any relevant information provided by the person diagnosed with HIV regarding any party with whom the person diagnosed with HIV has had sexual relations or has shared drug injecting equipment. The information may include the third party’s name, address, telephone number, and any other locating information known to the physician or physician assistant. The department shall use the information in accordance with procedures established for the voluntary partner notification program.

b.Notification of the third party and any disclosure concerning the purpose of that notification shall be made in person. However, initial contact with the third party may be made by telephone, mail, or other electronic means to arrange the meeting with the department representative. The nature of the matter to be discussed shall not be revealed in the telephone call, letter, or other electronic message.

11.10(7) Confidentiality. The physician or physician assistant of the person diagnosed with HIV and the department shall protect the confidentiality of the third party and the person diagnosed with HIV. The identity of the person diagnosed with HIV shall remain confidential unless it is necessary to reveal it to the third party so that the third party may avoid exposure to HIV. If the identity of the person diagnosed with HIV is revealed, the third party shall be presented with a statement in writing at the time of disclosure that includes the following or substantially similar language: “Confidential information revealing the identity of a person diagnosed with HIV has been disclosed to you. The confidentiality of this information is protected by state law. State law prohibits you from making any further disclosure of the information without the specific written consent of the person to whom it pertains. Any breach of the required confidential treatment of this information subjects you to legal action and civil liability for monetary damages. A general authorization for the release of medical or other information is not sufficient for this purpose.”

11.10(8) Immunity. A health care provider attending a person diagnosed with HIV has no duty to disclose to or to warn third parties of the dangers of exposure to HIV through contact with the person diagnosed with HIV and is immune from any liability, civil or criminal, for failure to disclose to or warn third parties of the condition of the person diagnosed with HIV.

Rules 641—11.9(139A,141A) through 641—11.10(141A) are intended to implement Iowa Code sections 139A.33 and 141A.5.

641—11.11(139A,141A) Care provider notification upon exposure to contagious or infectious diseases—exposures in nonclinical settings.

11.11(1) If a care provider sustains a significant exposure from a patient while rendering health care or other services, other than home-health or respite care services, outside of a health care facility or hospital, the care provider shall file a significant exposure report as soon as reasonably possible following the exposure. When the exposure occurred outside a clinical setting, a care provider who has sustained a significant exposure should file this report with the infection control, occupational health, or other designated office of the facility to which the patient was transported.

11.11(2) The source patient to whom the care provider was exposed is deemed to consent to a test to determine if the patient has a contagious or infectious disease and is deemed to consent to notification of the care provider or the designated representative of the results of the test, upon submission of a significant exposure report and certification of the significant exposure by an authorized infection preventionist, occupational health professional, or other professional trained in infectious disease control. No further consent from the source patient is required. However, as soon as is practicable, the source patient shall be notified that an exposure has occurred and shall be told which specific tests have been performed to determine the presence of contagious or infectious diseases. If the source patient is a minor, the minor shall be informed that, upon positive confirmation of an HIV-related test result, the minor’s legal guardian shall be informed of the positive result pursuant to Iowa Code section 141A.7(3).

11.11(3) Hospitals, clinics, or other health care facilities; institutions administered by the department of corrections; and jails shall have written policies and procedures pursuant to Iowa Code section 139A.19. In addition to those policies and procedures required by Iowa Code section 139A.19, hospitals, clinics, or other health care facilities; institutions administered by the department of corrections; and jails shall have written policies and procedures for reviewing and certifying significant exposure report forms, testing a source patient, and notifying a care provider who sustained a significant exposure while rendering health care services or other services to the source patient when the source patient is delivered to the facility and the exposure occurred prior to the delivery.

11.11(4) The hospital, clinic, or other health care facility to whom the source patient is delivered shall conduct the test. If the source patient is delivered to an institution administered by the department of corrections, the test shall be conducted by the staff physician of the institution. If the source patient is delivered to a jail, the test shall be conducted by the attending physician of the jail or the county medical examiner. If the source patient was deemed to consent upon certification of a significant exposure report, the sample and test results shall only be identified by a number.

11.11(5) If a test result is positive, the hospital, clinic, or other health care facility, or other person performing the test shall notify the source patient and make any required reports to the department pursuant to Iowa Code sections 139A.3 and 141A.6. The report to the department shall include the name of the source patient.

11.11(6) If a source patient is diagnosed or confirmed as having a contagious or infectious disease, the hospital, clinic, or other health care facility, or other person performing the test shall notify the care provider or the designated representative of the care provider who shall then notify the care provider. If the source patient is a minor and is diagnosed with HIV infection, the hospital, clinic, or other health facility, or other person performing the test shall notify the legal guardian of the minor.

11.11(7) The notification shall advise the care provider of possible exposure to a particular contagious or infectious disease and recommend that the provider seek medical attention. The notification shall be provided as soon as reasonably possible following determination that the source patient has a contagious or infectious disease. The notification shall not include the name of the source patient unless the patient consents. If the care provider who sustained a significant exposure determines the identity of a source patient who has been diagnosed or confirmed as having a contagious or infectious disease, the identity of the source patient shall be confidential information and shall not be disclosed by the care provider to any other person unless a specific written release is obtained from the source patient.

11.11(8) This rule does not preclude a hospital, clinic, other health care facility, or a health care provider from providing notification to a care provider under circumstances in which the hospital’s, clinic’s, other health care facility’s, or health care provider’s policy provides for notification of the hospital’s, clinic’s, other health care facility’s, or health care provider’s own employees of exposure to a contagious or infectious disease that is not life-threatening if the notice does not reveal a source patient’s name, unless the patient consents.

11.11(9) The infection control, occupational health, or other designated office of the facility shall maintain a record of all significant exposure reports it receives and shall retain each report for a period of five years.

11.11(10) The significant exposure report form is a confidential record pursuant to Iowa Code section 141A.9.

641—11.12(139A,141A) Care provider notification upon exposure to contagious or infectious diseases—exposures in clinical settings.

11.12(1) If a care provider sustains a significant exposure from a patient while rendering health care services or other services within a hospital, clinic, or other health care facility or while delivering home-health or respite care services, the care provider shall file a report as soon as reasonably possible following the exposure. A care provider who has sustained a significant exposure should file the report with the infection control, occupational health, or other office designated by the facility in which the exposure occurred, or by the facility that has oversight for the delivery of home-health or respite care services.

a.If a general consent form was signed and in effect at the time of the significant exposure and the source patient is an adult, a significant exposure report form shall not be required to document the significant exposure. The health care facility or hospital may use an employee incident report or other similar form for this purpose. The source patient to whom the care provider was exposed is deemed to consent to a test to determine if the patient has a contagious or infectious disease and is deemed to consent to notification of the care provider or the designated representative of the results of the test, upon submission and review of an employee incident report and certification of the significant exposure by an authorized infection preventionist, occupational health professional, or other professional trained in infectious disease control. No further consent from the source patient is required. However, as soon as is practicable, the source patient shall be notified that an exposure has occurred and shall be told which specific tests have been performed.

b.If no consent form was signed or in effect at the time of the exposure, or if the source patient is a minor, the source patient is deemed to consent to a test to determine if the patient has a contagious or infectious disease and is deemed to consent to notification of the care provider or the designated representative of the results of the test upon submission of a significant exposure report form and certification of the significant exposure by an authorized infection preventionist, occupational health professional, or other professional trained in infectious disease control. As soon as is practicable, the source patient shall be notified that an exposure has occurred and shall be told which specific tests have been performed to determine the presence of contagious or infectious diseases. If the source patient is a minor, the minor shall be informed that, upon positive confirmation of an HIV-related test result, the minor’s legal guardian shall be informed of the positive result pursuant to Iowa Code section 141A.7(3).

11.12(2) Hospitals, clinics, or other health care facilities; institutions administered by the department of corrections; and jails shall have written policies and procedures for reviewing and certifying significant exposure report forms or other employee incident report forms, testing a source patient, and notifying a care provider who sustained a significant exposure while rendering health care services or other services to a patient during the admission, care, or treatment of the patient at the facility or while delivering home-health or respite care services.

11.12(3) The hospital, clinic, or other health care facility where exposure occurred or that has oversight for the delivery of home-health or respite care services shall conduct the test. If a general consent form was signed and in effect and the source patient is an adult, the sample and test results shall be identified by name. If the source patient was deemed to consent to a test and to notification of the care provider upon certification of a significant exposure report pursuant to these rules because no general consent was signed and in effect at the time of the exposure or because the source patient is a minor, the sample and test results shall be identified only by a number.

11.12(4) If a test result is positive, the hospital, clinic, or other health care facility or other person performing the test shall notify the source patient and make any required reports to the department pursuant to Iowa Code sections 139A.3 and 141A.6. The reports to the department shall include the name of the source patient.

11.12(5) If a source patient is diagnosed or confirmed as having a contagious or infectious disease, the hospital, clinic, or other health care facility or other person performing the test shall notify the care provider or the designated representative of the care provider who shall then notify the care provider. If the source patient is a minor and is diagnosed with HIV infection, the hospital, clinic, or other health care facility or other person performing the test shall notify the legal guardian of the minor.

11.12(6) The notification shall advise the care provider of possible exposure to a particular contagious or infectious disease and recommend that the provider seek medical attention. The notification shall be provided as soon as reasonably possible following determination that the source patient has a contagious or infectious disease.

11.12(7) The infection control, occupational health, or other designated office of the facility shall maintain a record of all significant exposure reports it receives and shall retain each report for a period of five years.

11.12(8) The significant exposure report form is a confidential record pursuant to Iowa Code section 141A.9.

Rules 641—11.11(139A,141A) through 641—11.12(139A,141A) are intended to implement Iowa Code section 139A.19.

641—11.13(915) Testing, reporting, and counseling of convicted or alleged sexual assault assailants.

11.13(1) Prior to ordering an HIV-related test on a convicted or alleged offender pursuant to Iowa Code sections 915.40 through 915.43, the physician or practitioner shall provide information to the subject of the test concerning testing and where to obtain additional information on HIV transmission and risk reduction pursuant to Iowa Code section 141A.6. The department may be contacted for brochures that may assist in meeting the requirements of Iowa Code section 141A.6.

11.13(2) At any time that the subject of an HIV-related test is informed of confirmed positive test results, the physician or other practitioner who ordered the test shall initiate counseling concerning the emotional and physical health effects of HIV infection, as required under Iowa Code section 141A.7, and shall make any required reports to the department pursuant to Iowa Code section 141A.6.

a.The physician or other practitioner shall encourage a person diagnosed with HIV to participate in the voluntary partner notification program pursuant to rule 641—11.9(139A,141A).

b.The physician or other practitioner may provide to the department any relevant information provided by the person diagnosed with HIV regarding any party with whom the person has had sexual relations or has shared drug injecting equipment.

This rule is intended to implement Iowa Code section 135.11(22).

641—11.14(141A) Ryan White program.

11.14(1) General purpose and incorporation. The Ryan White program is a state-administered program that provides support services and assistance with the costs of health insurance and treatment medications for eligible low-income individuals diagnosed with HIV when adequate state and federal funding is available for administration of the program.

a.The program is authorized under Part B of Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87). This legislation requires that the Ryan White program, including the benefits and drug assistance program, be the payer of last resort for HIV-related services. The Ryan White program is not an entitlement program and does not create a right to assistance. In the event that funding is exhausted or terminated or there are changes in state or federal guidelines, programs, or regulations that impact funding available to the program, the department reserves the right to close enrollment, cease to provide specific services, or alter eligibility criteria until such time that funding is again sufficient.

b.The Ryan White program will be administered in accordance with the Ryan White Part B Client Services Manual dated December 2023, adopted and incorporated by this reference. The manual contains the policies and procedures utilized in the implementation of the program. The manual is updated annually. A copy of the manual is available at the department website.

c.The benefits and drug assistance program will be administered in accordance with the Benefits and Drug Assistance Program Manual dated December 2023, adopted and incorporated by this reference. The manual contains the policies and procedures utilized in the implementation of the program. The manual is updated annually. A copy of the manual is available at the department website.

11.14(2) Collaboration with Iowa Medicaid. To ensure that the Ryan White program is the payer of last resort and to maximize the efficiency and effectiveness of HIV-related prevention and care services, Iowa Medicaid shall grant the department access to client information for persons enrolled in Medicaid.

11.14(3) Confidentiality. Applications, assessments, and all other client-level information received or maintained by the department in connection with the Ryan White program shall be considered confidential information in accordance with Iowa Code section 141A.9.

This rule is intended to implement Iowa Code section 141A.3.

Public Health Department

Closed For Comments

This notice is now closed for comments. Collection of comments closed on 9/5/2024.

Official Document

  • Human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS), ch 11
  • Published on 8/7/2024
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  • Amended Notice of Intended Action

The official published PDF of this document is available from the Iowa General Assembly’s Administrative Rules page.

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View the Iowa Administrative Bulletin for 8/7/2024.

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