in-20250910-IR-410240588RAA: 410 IAC 1-1, IMMUNIZATION OF SCHOOL CHILDREN

TITLE 410 INDIANA DEPARTMENT OF HEALTH Readoption Reviews LSA Document #24-588 410 IAC 1-1, IMMUNIZATION OF SCHOOL CHILDREN

VII. Difficulties Encountered

The department is using grant funds to develop and publish a HL7 message segment to allow schools and providers to report immunization information directly to the state system rather than rely on manual data entry. FERPA is a barrier for schools and reporting of immunizations to the state as it requires parental consent.

VIII. Changes in Technology, Economic Conditions, or Other Factors

Improvements in technology have reduced the need for manual data reporting to IDOH and IDOH continues to work with regulated entities to minimize reporting burdens.

IX. Other State or Federal Requirements

Indiana requires immunization against (1) diphtheria; (2) pertussis (whooping cough); (3) tetanus; (4) measles; (5) rubella; (6) poliomyelitis; (7) mumps; (8) varicella; (9) hepatitis A; (10) hepatitis B; and (11) meningitis pursuant to IC 20-34-4-2. Indiana includes these immunizations in 410 IAC 1-1-1 and includes any additional immunizations recommended by IDOH and the CDC. Indiana’s immunization requirements match Ohio, South Dakota, Kentucky and Idaho. Michigan and Illinois do not require Hepatitis A vaccinations but otherwise share the vaccination requirements. While Indiana’s Hepatitis A vaccination requirement is a more stringent standard than Illinois’s requirements or Michigan’s requirements, there have been several Hepatitis outbreaks in Indiana since 2017 and vaccination against Hepatitis A is critical to prevent the spread of Hepatitis. As noted below, Indiana’s standard is less stringent than Ohio (which requires influenza, pneumococcal disease and rotavirus) and states like Illinois and South Dakota (which place stricter requirements on the type of immunization documentation. Illinois requires the same immunizations as Indiana in 77 Ill. Adm. Code 665.230 and 240 except that Illinois does not require Hepatitis A. Illinois requires proof of immunity under 77 Ill. Adm. Code 665.250 that is more strict than Indiana’s standard in 410 IAC 1-1-3 because Illinois requires laboratory evidence of immunity for varicella, hepatitis B, measles after July 1, 2022, and mumps if a physician does not verify the date of illness. South Dakota requires the same immunizations as Indiana in SD Codified Law 13-28-7.1 but unlike 410 IAC 1-1-3, only accepts certification from a physician that the child received or is receiving the vaccination or certification from a physician that immunization would endanger the child’s life or a written statement from a parent that immunization would be contrary to their religious doctrine. Ohio, in ORC Ann. 5104.014, requires the same immunizations as Indiana but also requires immunization against influenza, pneumococcal disease, and rotavirus. Proof of immunization must be written evidence satisfactory to the person in charge of admission to the school. Kentucky, in 902 KAR 2:060, requires the same immunizations as Indiana though the immunization requirements are listed in a schedule based on age. Kentucky also requires certificates of immunization signed by a physician; an advanced practice registered nurse; a physician assistant; a pharmacist; the local health department administrator; or a registered nurse or licensed practical nurse designee of a physician, local health department administrator, or other licensed healthcare facility. Michigan, in Mich. Admin. Code R 325.176, requires the same immunizations as Indiana except for Hepatitis A. Michigan only allows a certificate of immunity to be certified by a health professional or local health department. Idaho, in IDAPA 16.02.15.100, requires the same immunizations as Indiana. Under IDAPA 16.02.15.105, students are not required to obtain the required immunizations if the student has laboratory proof of immunity or a disease diagnosis from a healthcare professional.

XI. Integration into Indiana Code

The substantive content in this rule could be integrated into Indiana Code because the list of immunizations in 410 IAC 1-1-1 mirrors IC 20-34-4-2. The immunization record requirement in 410 IAC 1-1-2 matches the requirements in IC 20-34-4-5 and the reporting requirement in 410 IAC 1-1-4 matches the requirements in IC 20-34-4-6. The only difference is that 410 IAC 1-1-3 documentation of immunization can come from a healthcare professional, from the state immunization registry, or from the school corporation. IC 20-34-4-5(a) only allows documentation to come from the healthcare professional that administered the immunization or from the state immunization registry.

I. Statement Whether the Subject Matter Covered by the Rule Remains Carried out by the Agency

IC 16-41-2-1 gives IDOH the authority to pass administrative rules that establish reporting, monitoring, and preventative procedures for communicable disease reporting and control. 410 IAC 1-2.5 is the latest version of the rule first adopted on November 25, 2015, and readopted on November 12, 2021. The subject matter of 410 IAC 1-2.5 comprises a fundamental function of IDOH as the public health authority. IDOH is further required by IC 16-41-2-1 to publish a list of reportable communicable diseases; other diseases or conditions that pose a serious health risk; and control measures for each disease/condition on the IDOH website.

II. Rationale for the Continued Need for the Rule 

There is a continued need for 410 IAC 1-2.5. Along with definitions and a list of individual diseases and conditions, the rule gives specific directions for local health officers to implement, including timelines for reporting, disease-specific precautions, and treatment protocols. The rule allows for expedited reporting of diseases to protect the citizens of Indiana without the delay of the legislative process. Readoption of 410 IAC 1-2.5 will have an unchanged impact on regulated entities, e.g., the physicians, hospitals, and laboratories who are mandated reporters. The rule does not have a direct impact on persons who pay taxes or fees for government services or for the consumers of products and services affected by the rule. 410 IAC 1-2.5 achieves the regulatory goal of administering the list of communicable diseases and other diseases/conditions and their control in the least restrictive manner while incorporating best practices as referenced by the statute, namely the United States Centers for Disease Control and Prevention (CDC) and the Counsil of State and Territorial Epidemiologists referenced in IC 16-41-2-1. 410 IAC 1-2.5 is written for ease of comprehension to the greatest extent possible in that it defines terms, provides general guidance to reporters, then follows up with disease/condition-specific guidelines for practitioners and local health officers. 410 IAC 1-2.5 does not contain any fees, fines, or civil penalties for mandatory reporters.

V. Alternative Methods of Achieving the Purpose of the Rule

IC 16-41-2-1 requires IDOH to publish a list of reportable communicable diseases, other diseases or conditions that pose a serious health risk based upon the characteristics of the disease or condition, and control measures for the diseases and conditions on the IDOH website. Additionally, IDOH “may adopt rules under IC 4-22-2 that establish reporting, monitoring, and preventive procedures for communicable diseases.” 410 IAC 1-2.5 is a long administrative rule. Succussive versions of the rule have been filed and repealed since the rule was first promulgated in 1976. The rule takes a “belt and suspenders” approach to communicable disease reporting in that the list of reportable diseases is published both on the IDOH website and included in the administrative rule. IDOH continually evaluates the requirements of the rule to ensure it meets current standards and has removed diseases/conditions to be reported when appropriate to lessen the burden on mandatory reporters, e.g., medical providers, health care facilities, and laboratories.

IX. Other State or Federal Requirements

All the states reviewed have detailed statutory and regulatory schemes for the reporting and control of communicable and other reportable diseases and conditions. Most are similar to Indiana in that they include a lengthy administrative rule. Illinois’ administrative scheme is more complex than Indiana’s in that it involves multiple reporting steps. Other states involve broader reporting groups; for example, Kentucky requires “heads of household” to report, Michigan and Idaho require schools to report, Ohio requires poison control centers and pharmacies to report, and Idaho also requires day care and food service facilities to report. South Dakota’s rule is less detailed than Indiana’s in that it does not include detailed prevention and treatment measures for each communicable or reportable disease.

I. Statement Whether the Subject Matter Covered by the Rule Remains Carried out by the Agency

Prior to March 24, 2025, 410 IAC 1-3 Infectious Waste was housed with the Infectious Disease Epidemiology and Prevention Division (IDEPD). It has been transferred to the Consumer Services and Healthcare Regulation (CSHCR) commission. While under IDEPD, there have been approximately two investigations since 2016 in which Indiana Department of Health (IDOH) personnel were highly engaged in investigation related to non-adherence to State rule requirements. Eighty Indiana counties have trained staff and implemented systems to address conducting environmental inspections based on the requirements of this rule.

II. Rationale for the Continued Need for the Rule 

Yes, the problem this rule was intended to address still exists. There is still a need for uniform requirements for handling infectious waste in Indiana. The State department is required by IC 16-41-16-8 to adopt rules after considering multiple federal guidelines such as the EPA, CDC, OSHA, DOL, and Environmental Management. The Rule has not changed since 1998, so it may be out of date. Counties have enacted ordinances and have their own investigators. The Rule is the least restrictive as possible. The Rule is easy to comprehend. Counties are using HFI funds to fund inspectors and inspections. The statute allows the state to designate agents to inspect and investigate. So, if funding is stable, the Rule has practicable enforcement because counties are willing to do the work.

VII. Difficulties Encountered 

The Commission has difficulty administering the Rule from the agency level with agency employees. Most of the difficulties are related to delegating responsibilities to the local health departments in a uniform manner. The Indiana Code allows IDOH to delegate inspection and investigation authority, but IDOH has to handle the civil penalties process. Most counties were already doing this work on their own. Now, all 92 counties have opted in to HFI funding, and a stipulation of receiving the funding is that the local health departments must use HFI funding on a system to handle infectious waste enforcement.

IX. Other State or Federal Requirements

While Indiana’s rule may be more restrictive than some states below because more facility types are subject to the rule, the statute establishes the applicable facilities, so it is not because of the rule itself. Illinois is more restrictive than Indiana. Illinois regulates medical/infectious waste by incorporating the following into their Rule: Kentucky is the same as Indiana. In Kentucky medical/infectious waste management is governed by specific regulations, including those related to air quality for medical waste incinerators. (401 KAR 59:020 and 401 KAR 61:010), and hospital/nursing facility operations (902 KAR 20:016 and 902 KAR 20:300). “In Kentucky, there are no specific regulations pertaining to medical waste and there is no one agency with jurisdiction over medical waste. There are, however, regulations that reference the characterization, treatment, handling, labeling, storage, transport and disposal of this type of waste. These state regulations overlap between environmental, public health, labor and transportation agencies. They are intended to protect personnel, the public and the environment from exposure, injury or contamination of potentially infectious wastes.” https://eec.ky.gov/Environmental-Protection/Waste/recycling-and-local-assistance/Pages/medical-waste.aspx

XI. Integration into Indiana Code

This rule could be transferred to the Indiana Code, but it will need to be evaluated for overlap with existing statutes and federal requirements. XII. Contact Information of Staff to Answer Substantive Questions Ann Z. Knotek, Staff Attorney, Indiana Department of Health. (317) 233-7874; aknotek@health.in.gov 410 IAC 1-4, UNIVERSAL PRECAUTIONS I. Statement Whether the Subject Matter Covered by the Rule Remains Carried out by the Agency II. Rationale for the Continued Need for the Rule  III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6 IV. Cost-Benefit, Economic Impact, Fiscal Impact, or Regulatory Burden Statements iii. Facility  Est. Number in IN iv. Hospitals 130 v. Clinics 122 vi. Community Health Centers 35 vii. EMS Providers > 800 viii. Tattoo Parlors unknown; hundreds and increasing ix. Dialysis Centers > 300 x. Funeral Homes > 500 V. Alternative Methods of Achieving the Purpose of the Rule VI. Complaints and Comments VII. Difficulties Encountered  VIII. Changes in Technology, Economic Conditions, or Other Factors  IX. Other State or Federal Requirements X. Previous Amendments XI. Integration into Indiana Code XII. Contact Information of Staff to Answer Substantive Questions TITLE 410 IAC 3.2, Children with Special Health Care Needs I. Statement Whether the Subject Matter Covered by the Rule Remains Carried out by the Agency II. Rationale for the Continued Need for the Rule  III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6 IV. Cost-Benefit, Economic Impact, Fiscal Impact, or Regulatory Burden Statements V. Alternative Methods of Achieving the Purpose of the Rule VI. Complaints and Comments VII. Difficulties Encountered  VIII. Changes in Technology, Economic Conditions, or Other Factors  IX. Other State or Federal Requirements X. Previous Amendments XI. Integration into Indiana Code XII. Contact Information of Staff to Answer Substantive Questions 410 IAC 5, RADIOLOGICAL HEALTH

II. Rationale for the Continued Need for the Rule

There is a continued need for this rule because this rule creates standards for use of ionizing radiation, including the use of x-ray machines. Without this rule, the public could be harmed by improper medical care.

VIII. Changes in Technology, Economic Conditions, or Other Factors 

The last time the rule was amended was 1993. Since then, there have been technological changes that should be considered for updating the rule. Handheld dental x-ray units are relatively new and are manufactured to be handheld versus a wall mounted dental intraoral x-ray machine, which is not manufactured to be handheld. All technical parts of the rule should be reviewed for applicability and/or updating if necessary. Further, there is no longer a physicist review committee to approve physicist or x-ray machine applicants. This function is done by staff employed by IDOH’s Consumer Services and Healthcare Regulation Division of Radiology and Weights & Measures. Note: 410 IAC 5-3 Licensing of Radioactive Material, can be transferred since radioactive material is regulated by the Indiana Department of Homeland Security now.

IX. Other State or Federal Requirements

There are no federal requirements regarding radiation health. Illinois radiology requirements are set by 31 Ill. Adm. Code 335. That code is substantially similar to Indiana’s because it also sets standards for radioactive material handling, radiation dosages, and calibration standards. Illinois also regulates mobile nuclear medical services in 32 Ill. Adm. Code 335.2120. Illinois is an agreement state, which means that it handles the Nuclear Regulatory Commission’s duties in the state. Idaho regulates medical radiology under IDAPA 16.02.27. It has similar licensing provisions for radiation machine facility but, similar to Indiana, Idaho is a non-agreement state. That means the Nuclear Regulatory Commission handles radioactive material licenses rather than the state of Idaho. Michigan - MICH. ADMIN. CODE R 333.500 et seq regulates medical radiology in a manner substantively similar to Indiana. Michigan is a non-agreement state. Michigan’s rule requires a radiation safety officer training course that substantively matches the requirement in 410 IAC 5-3-12. Ohio statute ORC Ann. 3748.01 et seq, like Indiana, certifies radiation experts, facility inspections, and penalties for violations. Like Indiana, Ohio statute also sets disposal requirements. Kentucky regulates medical radiology in KRS § 311B.010 et seq. Kentucky is an agreement state, which means that it handles Nuclear Regulatory Commission’s duties in the state. The fact that Kentucky is an agreement state is the substantive difference between Kentucky’s standards. South Dakota – South Dakota regulates medical radiology under ARSD 44:03:01.01 et seq. Like Indiana, South Dakota is a non-agreement state. South Dakota’s standards are substantially similar to Indiana’s standards because it also regulates radiation experts, facility standards, and radiation dosage standards and requirements.

XI. Integration into Indiana Code

This rule is highly technical in nature and may not be well suited for integration into the Indiana Code. Further, this rule is meant to be updated based on changes in medical technology. If this rule were integrated into the Indiana Code, the Code could have to be updated multiple times to stay current with medical practice and industry standards. These concerns could be addressed by amending IC 16-41-35-28 to state that IDOH is adopting the recommendations of the National Council on Radiation Protection and Measurements. However, doing so would prevent IDOH from any deviation from those recommendations.

II. Rationale for the Continued Need for the Rule 

IDOH is required by statute to operate program that certifies radon testers and mitigators, so the rule continues to be necessary. It is important that testing and mitigation are properly performed because exposure to radon causes lung cancer. Those providing these services are required to be trained and certified by either the National Radon Proficiency Program (NRPP) or the National Radon Safey Board NRSB. IDOH’s certification program is based on national standards because the EPA has already formulated a National Radon Action Plan that provides a framework for reducing radon exposure to acceptable levels. IDOH has not been able to identify a less costly or intrusive alternative. Indiana’s license cost is very competitive compared to adjoining states and IDOH has seen tremendous growth in the radon program. IDOH’s rule is not intrusive to businesses. Should a complaint be filed against a professional, IDOH only advises on next steps. It is not a requirement they follow those recommendations to keep their license. The rule is written for ease of comprehension, and the enforcement is practicable. The requirements of the rule do not have any additional requirements than the existing federal guidelines established by the EPA. IDOH is required to certify testers and mitigators by Indiana Code. IDOH did so by implementing the researched methods supplied by the EPA into this administrative Rule.

III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

The rule describes the circumstances for which IDOH will assess a civil penalty as a range of potential dollar amounts, stating the factors that IDOH will utilize to set a specific dollar amount in an individual case with sufficient certainty that a review of an agency action or comparable process can evaluate whether the amount was reasonable. Therefore, it complies with the requirements of IC 4-22-2-19.6. Indiana’s license is the lowest cost radon license compared to Ohio, Illinois, and Kentucky. Costs in these states range from $250 to $600. With Indiana’s only costing $100, we are the most affordable in the Midwest. There are several licensees from other states acquiring Indiana licensures from the Chicagoland area, Cincinnati, and Louisville area. Indiana’s costs do not limit financial growth in our state or others. Michigan does not require state registration.

VI. Complaints and Comments

Since summer of 2022, complaints received from the public concerning the implementation of the rule by the agency only occurred during a reporting transition period January through February 2023. Once IDOH completed an online database allowing licensed radon individuals to upload their reporting on their own, licensees had to learn how to access and upload that information. Complaints were limited to site functionality and a learning curve for the licensees. IDOH has seen leaps in on time reporting since the 2023 reporting year. From 52% on time reporting in 2023 to 67% on time reporting, our ability to work with our licensees has seen great improvements. This year we have 96% compliance with reporting, our main requirement to keep their license. Inactive licenses are suspended and most often are not renewed.

IX. Other State or Federal Requirements

Illinois has similar requirements to Indiana. 32Ill. Adm. Code 422 Kentucky has similar requirements to Indiana Radon Statutes:  Michigan: The program has been transferred to the Department of Environmental Quality. There is no administrative rule or license requirement. Ohio has similar regulations to Indiana. Ohio Administrative Code 3701-69 & Ohio Revised Code 3723.09. Idaho does not have a license requirement for testers or administrative rule. South Dakota: no license requirement for testers or administrative rule. Michigan, Idaho, and South Dakota do not have license requirements. Indiana is stricter than only these three states as part of the required state review. From a public health standpoint, making sure the entities performing this type of work on Indiana residents’ homes are certified protects Indiana residents’ investments in their homes and health. Additionally, state law requires this program.

X. Previous Amendments

History and Background of the Rule - The Indiana Code requires that IDOH certify radon testers and mitigators. IDOH promulgated a rule based on federal framework from the EPA because the methods are researched. This provides a reliable certification system to protect the health of Indiana residents. The last major update was in 2021. The amendment amended 410 IAC 5.1-1-9, 410 IAC 5.1-1-10, 410 IAC 5.1-1-16, and 410 IAC 5.1-1-18 to revise definitions. The amendment also amended 410 IAC 5.1-1-22 through 410 IAC 5.1-1-29 to revise the certification and standards requirements applicable to radon testing, radon mitigation, and laboratory analysis. The amendment amended 410 IAC 5.1-1-31 to revise the documents incorporated by reference as part of this rule. Lastly, it repealed 410 IAC 5.1-1-3.

II. Rationale for the Continued Need for the Rule 

There is a continued need for the foundation this rule sets for public and semi-public pools. The program that covers this rule is still in use and local health departments use the rule to make sure pools are safe. The rule is simple, concise, and the regulated industry has had many years to adapt to it. It has remained unchanged for 15 years. The current rule presents the lowest short-term cost for the regulated industry, while still providing the foundation for the aquatic venue safety and sanitation that the general public expects. Enforcement of the Rule is challenging for some local health departments with limited resources. IDOH cannot identify any ways to reduce costs or make the rule less restrictive for regulated entities.

VI. Complaints and Comments

Overall, the rule has been well established with few complaints lodged since the last review in 2021. Lifeguarding: There has been one recent (11/21/2024) formal complaint letter filed requesting a very specific exemption to the lifeguard expectation for age 55+ communities with pools larger than 2,000 square feet that don’t allow minors. Exemptions are not an option in the rule. They wanted an “exemption” because of the cost of hiring a lifeguard. It would seem unfair to the rest of the regulated community to provide for this specific exemption. Allowing such an exemption based on specific caveats would also be difficult for local health departments (LHD) to monitor and enforce. Small cold plunges: Some small business owners as well as regulators have stated that they would prefer clear statements regarding the handling of small, one-patron cold-plunge spas in a commercial setting. The popularity of these small venues has increased considerably over the course of the past year. It has been possible to address these relatively new venues using the existing 410 IAC 6-2.1 and 675 IAC 20 (coordinating with partners at Indiana Department of Homeland Security). The two key cold-plunge manufacturers (at this point) have been working with IDOH to develop products which are more appropriate for commercial sales/use.

VII. Difficulties Encountered 

The greatest difficulty in administering the 410 IAC 6-2.1 rule has been the limitation of some local health departments to expend the necessary time of trained, qualified staff to effectively administer it. Public/semi-public swimming pool inspections have not historically been an expected/mandated requirement of LHDs. LHD administrators/managers know this and have often been forced to make hard decisions regarding which priorities to address using limited staff resources. Health First Indiana funds for additional LHD staff, as well as Core Services’ expectations tied to said monies, are expected to address this limitation over time. It will, of course, take time to hire and train the necessary staff and get LHD pool inspection programs running effectively.

VIII. Changes in Technology, Economic Conditions, or Other Factors 

Conditions are largely the same as they were in November 2021 when 410 IAC 6-2.1 was last reviewed. The rule is relatively concise, simple, and the regulated industry has had many years to adapt to it (over 15). The IDOH working with LHDs have been able to effectively interpret the 2010 rule to implement basic safety and sanitation expectations, even across the wider variety of modern aquatic venues. Thanks to a pool industry that has adapted to 410 IAC 6-2.1, some of the costs of compliance (particularly regarding disinfectant feed and control) have reduced considerably in recent years. Chemical feed technology has evolved to the point that it is considerably easier and more cost-effective to comply with 410 IAC 6-2.1-30 than it was at the time of the last readoption. There are now simple, easy-to-use chemical feeders that owner/operators can purchase, install, and maintain with options under $500. Most indoor operations required more complex, professionally installed/maintained systems in the past that carried initial price tags of roughly $3000 to as high as $10,000. For many outdoor seasonal aquatic venues, this same new disinfectant feeder technology has alleviated the need to drain and refill pools one or two times per season; such was often necessary while using the lower-cost disinfectant feeders available in the past. New technologies involving on-site daily chemical testing have become available in recent years. These could make it easier to comply with the daily monitoring requirements of 410 IAC 6-21-30 at unstaffed facilities, although these technologies are still being perfected, are still costly, and are not yet widely used.

IX. Other State or Federal Requirements

Illinois has three statutes and a rule. It is slightly more regulated and includes beaches. https://dph.illinois.gov/topics-services/environmental-health-protection/swimming-facilities.html#laws-and-rules Kentucky has two statutes and two rules which include beaches. It covers about the same except Kentucky includes penalties. https://www.chfs.ky.gov/agencies/dph/dphps/emb/Pages/pools.aspx Michigan is the same as Indiana. https://www.michigan.gov/egle/-/media/Project/Websites/egle/Documents/Forms/DWEHD/Public-Swimming-Pool/EQP2263-Public-Act-and-Rules-Governing-Public-Swimming-Pools.pdf?rev=ac420bf9af3d4929a0645b2d98f327bb Ohio is the same as Indiana. 3749 Ohio Revised Code (ORC) & 3701-31 Ohio Administrative Code (OAC) Idaho just passed House Bill 202 which removes state-level sanitation standards for public pools, giving authority to local jurisdictions. This change took effect on July 1, 2025. IDOH does not recommend taking this stance because this would risk the health and safety of Hoosiers for the reasons stated throughout this document. South Dakota has an administrative rule. Pool operators must comply with the "Recommended Standards for Swimming Pool Design and Operation," 1996 edition, Great Lakes-Upper Mississippi River Board of State and Provincial Public Health and Environmental Managers. In addition, operators must take weekly samples and log them. All of the States are more restrictive than Indiana except Idaho. Our local health departments already have limited resources and the uniform rule that is already established eliminates the need for each local health department to promulgate/research regulations.

IX. Other State or Federal Requirements

Illinois’s regulation is comparable. It has both a statute and a rule. Its rule covers more topics than ours. https://dph.illinois.gov/topics-services/environmental-health-protection/manufactured-modular-homes-mobile-structures.html#laws-and-rules Kentucky’s regulation is also comparable. It also has both a statute and a rule. KRS 219.370 & 815 KAR 20:170 Michigan’s regulation is comparable, but includes slightly more protection for occupants The Mobile Home Commission Act 96 of 1987 https://www.legislature.mi.gov/Laws/MCL?objectName=mcl-Act-96-of-1987 & Regulated by the Department of Environmental Quality MAC section 125 Ohio’s regulation is comparable and is found in both statute and rule, but enforcement is by the Ohio Manufactured Homes Commission, not the Health Department. Ohio Administrative Code 4781-12 & Ohio Revised Code 4781 Idaho does not have a state-level regulation but rather relies on local ordinances. IDOH does not recommend this option because a uniform rule across the state serves operators and residents in a more efficient manner. Also, some local health departments do not have the resources to regulate in this area. South Dakota: None. IDOH does not recommend this approach because Indiana’s population is over five times greater than South Dakota’s. IDOH actively investigates sanitation violations that risk Indiana residents’ health.

IX. Other State or Federal Requirements

Illinois: Illinois has a statute and a rule that are similar to Indiana’s rule. 210 ILCS 110 & Public Act 098-1034. Illinois requires a permit only for camps that have over 10 workers or more than four families. Indiana’s rule is more specific, but Illinois’ rule references other laws and rules. For example, Illinois’ rule adds water testing, sewage compliance, and construction approvals that are based on other state codes. Indiana’s rule is more specific regarding exact ratios, square footage, and facility requirements. Kentucky: Pursuant to 803 KAR 2:600 and a state plan approved by the US Department of Labor, OSHA, Occupational Safety and Health (Kentucky’s agency) standards for Agriculture, all employers, employees, and places of employment engaged in agricultural operations must comply with the federal rule, 29 CFR Part 1928. IDOH does not recommend leaving this rule to federal control. The conditions witnessed during inspections show that this rule and state inspections are necessary to protect the health and safety of Indiana residents. Kentucky has relinquished jurisdiction for the issues related to Field Sanitation (29 CFR 1928.110) and Temporary Labor Camps (29 CFR 1910.142) in agriculture except for agricultural temporary labor camps associated with egg, poultry or red meat production, or the post-harvest processing of agricultural or horticultural commodities. In Kentucky, the Employment Standards Administration, U.S. Department of Labor, has assumed responsibility for the enforcement of these OSHA standards. Michigan: Michigan’s regulations are the same as Indiana. Michigan Administrative Code R 325.3601 to R 325.3612 and MCL 333.12421. Both states aim to protect agricultural and the surrounding area through comprehensive regulations, with Indiana focusing on the facility and Michigan emphasizing broader compliance and enforcement mechanisms. For example, Michigan charges $1,000 per day for operating without a license, and operators must provide evidence of worker’s employment upon request. Ohio: Ohio has a statute and rule. Ohio’s rule is more robust than Indiana’s. Ohio Administrative Code 3701-33 and Ohio Revised Code 519.01. Ohio’s equivalent of what would be the Indiana Department of Homeland Security also regulates portions of labor camps. Their multi-agency approach allows for broader oversight of labor camps. Ohio’s rule also provides more procedural avenues for enforcement, including the ability to act before a camp operates, and formal recourse through hearings and legal action. Idaho: Idaho repealed its agriculture labor law, so they rely on federal law. South Dakota: South Dakota does not have a statute or rule on this issue and relies on the federal law. Federal: The Migrant and Seasonal Agricultural Worker Protection Act (MSPA) protects migrant and seasonal agricultural workers by establishing employment standards related to wages, housing, transportation, disclosures, and recordkeeping. Some of the requirements in the Indiana Rule are in the MSPA. Some of the regulations in the Indiana Rule go further MSPA regulations. For example, where there are shared toiled facilities, separate rooms are needed for each sex under the MSPA. In Indiana, separate rooms must have floor-to-ceiling solid walls. The IDOH rule is stricter than federal regulations because those provisions require additional sanitation benefits that are necessary based on IDOH’s history of inspection of the facilities. The federal rule is best suited for smaller agricultural labor camps and Indiana has many larger camps that require additional regulation. IDOH already receives complaints from the public who are near agricultural labor camps that the camps are not sanitary. Any further lessening of these regulatory requirements would produce less sanitary conditions. As noted above, IDOH has not received complaints from the regulated community about the stringency of the rule.

VIII. Changes in Technology, Economic Conditions, or Other Factors 

This rule was adopted in 1992. Since then, food safety standards have changed. Further, the need for this rule has changed due to businesses like Airbnb and Vrbo because there are fewer locations operating as bed and breakfasts and residences that are rented via Airbnb and Vrbo do not meet the definition of bed and breakfast establishment unless they provide breakfast to guests. This rule was last readopted in 2019. Since then, Indiana has moved from the potentially hazardous food standard to the time/temperature control for safety food (TCS) standard in both IC 16-42 and the retail food code, 410 IAC 7-26. The TCS standard reflects current food safety standards issued by the US Food and Drug Administration.

IX. Other State or Federal Requirements

There are no federal standards on bed and breakfast establishments. Neither the surrounding states nor the states identified by OMB have less stringent standards than Indiana. Illinois’s Bed and Breakfast Act, located at 50 ILCS 820, is substantially the same as 410 IAC 7-15.5. Both Illinois’ Act and this rule incorporate the “potentially hazardous food” standard that has been abandoned by the FDA and the food service industry in 2013. Kentucky regulates food establishments, including bed and breakfasts, consistent with the 2013 FDA Model Food Code. This standard is stricter than Indiana’s standard, which does not require compliance with a model food code. Michigan’s Food Law of 2000 as amended holds bed and breakfasts to the same standard as other food establishments. They must comply with the 2013 FDA Model Food Code. This standard is stricter than Indiana’s standard, which does not require compliance with a model food code. Ohio regulates food establishments, including bed and breakfasts, consistent with the 2013 FDA Model Food Code pursuant to ORC Ann. 3731.01. South Dakota, in ARSD 44:02:06 has not adopted an FDA code. However, the standard adopted is substantially similar to Indiana’s standard and also incorporates the potentially hazardous food standard. Under IDAPA 16.02.19.002, Idaho adopts the 2013 model food code but Idaho Code § 39-1602 exempts bed and breakfasts from following the code. As a result, Idaho’s standards are substantially similar to Indiana’s standards because Indiana also exempts bed and breakfasts from food code standards.

XI. Integration into Indiana Code

The substantive content in this rule is not appropriate for integration into the Indiana Code because it reflects food safety standards, and those standards change depending on market conditions and technology available. Several provisions of this rule are based on outdated versions of the FDA Model Food Code and are inconsistent with current provisions of IC 16-42-5. Instead of adopting this rule into the Indiana Code, IDOH will work to repeal this rule. At that time, IDOH will incorporate this rule into the newly adopted 410 IAC 7-26 and simultaneously update this incorporated language to reflect current standards. Despite this plan, IDOH does not have an estimated date that this repeal and incorporation into 410 IAC 7-26 will take place. Any amendment to 410 IAC 7-26 must be made in consultation with the Indiana Restaurant & Lodging Association to ensure that any edits being proposed adequately reflect business and food safety needs. Additionally, the statute separating bed and breakfast facilities should be repealed to support treating bed and breakfasts the same as all other retail food establishments.

IX. Other State or Federal Requirements

There are no federal requirements. Illinois statute 225 ILCS 470 adopts the same NIST handbooks as Indiana but also adopts subsequent publications – unlike Indiana which adopts the 2013 handbooks specifically. Michigan statute MCLS § 290.628c adopts the same handbooks as Indiana but adopts the 2023 edition. Ohio statute ORC Ann. 1327.49 adopts the NIST handbooks without reference to a specific year. Kentucky statute KRS § 363.590 explicitly adopts the most recent NIST handbooks. Idaho Administrative Code IDAPA 02.02.14.004 adopts the 2023 versions of the NIST handbooks used in Indiana. South Dakota adopts the 2020 NIST handbooks in ARSD 20:01:02. Indiana’s standard is more restrictive than the comparison states because the NIST handbook 130 adopted doesn’t reference e-commerce and biodiesel. It also has substantially fewer standards relevant to e-commerce. Further, because later standards are adopted by the surrounding states, Indiana keeping to the 2013 standard creates a burden on industry.

IX. Other State or Federal Requirements

There are no federal requirements. The only states that have requirements comparable to this rule are Illinois and Ohio. Illinois statute 410 ILCS 68/35 is substantially similar to the prohibitions in this rule, but no statute or regulation was found that were comparable to sections four through six. Ohio Administrative Code OAC Ann. 4101:6-1 is substantially similar to this rule because it contains the licensing and sanitation requirements to Indiana, though Ohio Administrative Code 4101:6-1-17 covers some miscellaneous fillers not covered by this rule. Kentucky and Michigan allow the sale of used mattresses but require them to be labeled as such. Idaho and South Dakota require resellers to contact their local health department. Bed bug infestation of used mattresses (and other used items, such as furniture) is a known problem. Indiana has chosen to try to prevent it, rather than leaving people to choose to risk infestation or with having to go to court for a remedy when labels are not applied. Indiana’s status as a crossroads means that more people could be affected by bed bugs and disease due to improperly cleaned mattresses. While no laws in the OMB identified states were equivalent to requirements in sections 3 through 5 related to filing and labeling requirements, these sections create standards necessary to enforce false advertising laws related to bedding.

II. Rationale for the Continued Need for the Rule 

As the designated surveyor for certified facilities, IDOH will lose the related CMS funding if it fails to meet the required expectations. In other words, these regulations ensure the cost of IDOH’s programs, including the salaries and benefits of those employees involved in regulatory activities, are covered by federal funds. The rule largely mirrors federal regulations which all skilled nursing facilities and nursing facilities which accept Medicare and/or Medicaid must follow. Nursing facilities certified by the Medicare and/or Medicaid program are subject to federally mandated and state-enforced quality and safety standards. IDOH has entered into an agreement with the Secretary of Health and Human Services under Section 1864 of the Social Security Act whereby IDOH is tasked with surveying facilities and enforcement activities. HHS provides funding for these activities. IDOH’s rules are written to give clarity and ease of reference. The rule largely mirrors federal regulations which all skilled nursing facilities and nursing facilities which accept Medicare and/or Medicaid must follow. Nursing facilities certified by the Medicare and/or Medicaid program are subject to federally mandated and state-enforced quality and safety standards. Because these rules are based on CMS regulatory requirements, no action on behalf of IDOH can minimize the economic impact.

III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

The rule provides for civil penalties for comprehensive care facilities at 410 IAC 16.2-3.1-2(m)(1) and 410 IAC 16.2-3.1-2(m)(2) and for residential care facilities at 410 IAC 16.2-5-1.1(m)(1) and 410 IAC 16.2-5-1.1(m)(2). The civil penalties are statutory in nature, being set forth at 16-28-5-4. Both the statute and corresponding rule set forth a fine not to exceed 10,000 in addition to other penalties. The rule categorizes breaches of the rules into offenses or deficiencies. An offense presents a substantial probability that death or a life-threatening condition will result and a fine shall be issued not to exceed $10,000. A deficiency presents an immediate or direct, serious adverse effect on the health, safety, security, rights, or welfare of a resident and a fine shall be issued not to exceed $5,000. The program uses a template (please refer to table below) to determine the amount of a fine to maintain consistency. The issuance of a fine is subject to appeal rights under AOPA. This fine section of the rule is currently being updated to include the factors used to determine the fine.

V. Complaints and Comments

Complaints or comments received from the public regarding this rule, or the subject matter, have been in regard to parts of the rules that need to be updated to conform to federal requirements, new guidance for tuberculosis testing, and parts that can be eliminated for more efficient and quality delivery of care to residents. VII. Difficulties Encountered  There have been no difficulties encountered in administering the rule or in small businesses complying with it. The majority of facilities are owned by either large corporate entities or hospitals. VIII. Changes in Technology, Economic Conditions, or Other Factors  Changes in technology include the widespread use of electronic medical records. Economic changes include the national nursing shortage, which can affect a facilities staff to patient ratio. This has been addressed statutorily by expanding the use of qualified medication assistants. IX. Other State or Federal Requirements Because all states must follow CMS regulations, none are less restrictive than the federal rules. The only exception is assisted living facilities, which are not required to be licensed in Indiana if they do not provide nursing services. By statute we do have regulations addressing memory care units. Most states license all facilities as residential facilities. The following charts show the areas that Indiana regulates compared to CMS and the identified states: Long Term Care INDIANA KENTUCKY OHIO MICHIGAN ILLINOIS IDAHO SOUTH DAKOTA CMS 410 IAC16.2-3 902 KAR 20:048 Ohio Admin. Code 3701-17 Mich. Admin. Code r. 325.20101 "Ill. Admin. Code tit. 77 § 300 IDAPA 16.03.02 Iowa Art 44:73 42 CFR 483 RESIDENT RIGHTS x x x x x X BY INCORPORATION x x THE ADMINISTRATION AND MANAGEMENT OF HEALTH FACILITIES x x x x x X x x SANITATION AND SAFETY STANDARDS x x x x x X x x ASSESSMENT OF RESIDENTS’ NEEDS x x x x x X x x MEDICAL AND NURSING SERVICES x x x x x X x x FOOD AND NUTRITION SERVICES x x x x x X x x INFECTION CONTROL x x x x x X x x ACTIVITIES AND SOCIAL SERVICES PROGRAMS x x x x x X x x CLINICAL RECORDS x x x x x X x x Types of facilities INDIANA KENTUCKY OHIO MICHIGAN ILLINOIS IDAHO SOUTH DAKOTA CMS COMPREHENSIVE CARE FACILITIES X X X x X X X x INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED X X X x X X X x RESIDENTIAL CARE FACILITIES X X x x X X X x HEALTH CARE FACILITIES FOR CHILDREN X X X x X X X x HEALTH CARE FACILITIES FOR DEVELOPMENTALLY DISABLED PERSONS X X x x X X X (REGULATIONS FOR BOTH MENTALLY AND DEVELOPMENTAL DISABILITIES COMBINED) x ASSISTED LIVING Dementia Units only X x N/A X X (COMBINED WITH RESIDENTIAL CARE FACILITIES) X (COMBINED WITH RESIDENTIAL CARE FACILITIES) N/A

II. Rationale for the Continued Need for the Rule 

There is a continued need for 410 IAC 21-1, implementing the State Cancer Registry. The Indiana State Cancer Registry (ISCR) was established in 1985 with the passage of IC 16-38-2 “for the purpose of recording all cases of malignant disease and other tumors and precancerous diseases required to be reported by federal law or federal regulation or the National Program of Cancer Registries that are diagnosed or treated in Indiana.” Readoption of 410 IAC 21-1 will continue to have the same impact on regulated entities, such as hospitals, laboratories, and other facilities that are mandated reporters. Reporting facilities are offered the use of free cancer data abstracting software, and the registry provides IT user support to facilities at no cost to minimize the expenses to regulated entities. Persons who pay taxes or fees for government services are not affected by the rule, nor are consumers of products and services of regulated entities affected by the rule. 410 IAC 21-1 achieves the regulatory goal of administering the ISCR in the least restrictive manner while incorporating best practices as defined by the CDC’s National Program of Cancer Registries (NPCR) and the Indiana State Cancer Registrars’ Association. The rule is divided into sections that provide definitions; general requirements; reporting requirements specific to hospitals; reporting requirements for physicians, dentists, and medical laboratories; provisions for the security and confidentiality of data; and reporting responsibilities for IDOH. 410 IAC 21-1 incorporates the NPCR’s requirements for state cancer registries, including for the collecting and submitting of reportable data, the use of standardized coding and formats, and the maintenance of data security. These requirements need to be reduced to statute or administrative rule by Indiana. 410 IAC 21-1 is written for ease of comprehension in that the two main types of entities regulated, hospitals and individual/smaller providers, are covered in separate sections of the rule. Sections on definitions and general requirements provide basic information, and the section on data security and confidentiality places responsibility on IDOH to safeguard data belonging to individuals with cancer. 410 IAC 21-1 does not contain any fees, fines, or civil penalties for mandatory reporters.

VII. Difficulties Encountered 

IDOH has been impacted financially and operationally from processing large quantities of paper reports of cancer cases coming from non-hospital facilities and some pathology laboratories as permitted by the current administrative rule. Because the rule allows for facilities to report cases by paper, IDOH spends $101,292 per year ($69.00/hour for 1468 hours) for abstracting costs. Other states have phased out paper reporting, with reporters required to submit data electronically. IDOH has a backlog of over 19,000 cases, which undermines data completeness and caused IDOH to miss CDC standards for years 2022 through 2024 due to incomplete case counts. IDOH seeks to amend the existing administrative rule or shift the administrative rule to Indiana Code. The Indiana Cancer Registrar’s Association, representing stakeholders, has independently moved its members to transition to electronic reporting only as of January 1, 2026. IDOH has been stepping up the encouragement of reporters to shift from paper reporting to electronic reporting

VIII. Changes in Technology, Economic Conditions, or Other Factors 

IDOH would like to change the terms of 410 IAC 21-1 so that only electronic reporting is used by reporters. In July 2024 and independent of IDOH, the Indiana State Cancer Registrars’ Association voted to mandate e-reporting as the only reporting method for its members beginning in January 2026. Technology has expanded options for both large and small providers, and IDOH provides free abstracting software and tech support to reporters. A savings of $101,292 in agency funds would benefit the taxpayers of Indiana, and shifting to electronic reporting only would promote Indiana’s efforts to gain compliance with CDC standards.

IX. Other State or Federal Requirements

Federal Regulations – The Cancer Registries Amendment Act (October 1, 1992) requires all states to enact an authorizing law and regulations in eight categories: 1) require reporting of newly diagnosed cancer cases by hospitals and other health-care facilities; 2) require reporting of cancer cases by physicians and other health-care practitioners; 3) guarantee access by the statewide cancer registry to all records of medical status of persons with cancer; 4) require the use of standardized reporting formats; 5) ensure confidentiality of cancer case data; 6) allow use of confidential case data by certain researchers; 7) authorize the conduct of studies using cancer registry data; and 8) ensure the protection of persons complying with the law from liability. See 42 USCS §280e(c)(2). Illinois – The Illinois Department of Public Health may promulgate rules or regulations directing hospitals, laboratories, etc. to submit information to the cancer registry, including the types of information required to be submitted, methods of submission, and “any other detail … necessary or appropriate for administration” of the statute at 410 ILCS 525. The Illinois administrative code at 77 Ill. Adm. Code 840 divides applicable rules into general registry provisions encompassing six public health-related registries, including the Illinois State Cancer Registry. Included are sections on definitions, incorporated and referenced materials, availability of registry information, administrative hearings, quality control measures, and fees for summaries or analyses of data not already prepared by the department. Illinois’ statute is more restrictive than Indiana’s in that fines can be assessed against non-compliant reporting facilities.  Kentucky – The Kentucky Cancer Registry (KCR) is established at KRS 214.556 in the statute enacting the Breast Cancer Screening Program. The state cancer patient management system is administered by the Lucille Parker Markey Cancer Center. Information is reported to the KCR through the cancer patient management system. Failure to do so can be punished by fines. Information in the registry is privileged and not subject to public records requests. The registry is tasked with reporting responsibilities to various legislative and executive bodies. There is no administrative rule in Kentucky for the cancer registry. The statute is more restrictive than Indiana’s in that Kentucky statute provides that fines can be assessed against non-complaint reporting facilities. Michigan – Michigan’s cancer registry is found in Part 26 of the Public Health statute on Data, Information, And [sic] Research at §333.2619. The section establishes the registry and provides for its purpose, reports, records, rules, collection of data, and reporting. The statute directs the promulgation of rules on 1. a list of diseases to be reported, 2. how cases and information are to be reported, and 3. the terms and conditions under which individual records are to be released. Administrative rules on Cancer Reporting are found at Mich. Admins. Code R 325.9050 through 325.9056. Sections cover details about the registry, definitions, reportable diagnoses, quality of data, confidentiality of reports, the establishment of a scientific advisory panel to review research requests, release of cancer data for research, and exchange of records to other state or national cancer registries. The main difference between Michigan’s administrative rule and Indiana’s is that Michigan’s rule provides for a scientific advisory panel to review research requests and for the exchange of cancer records with other state or national cancer registries. Ohio – The statute for the state cancer registry is found at Title 37 §3701.262 of the Ohio Revised Code. It includes definitions and authorizes the director of the health department to adopt rules to establish the registry, specify the types of cancer and related diseases to be reported, establish reporting requirements, and establish standards for research projects seeking individual case information. Health care providers and hospitals are required to provide information. The department is granted access to individual medical records. An Ohio cancer hospital and university research institute are directed to analyze and evaluate the reports made to the registry and publish publicly available reports each year. Reporters are not to be held liable for damages for reporting. Facilities can keep their own registries in addition to reporting to the registry. Ohio’s administrative rules for the Ohio Cancer Incidence Surveillance System are found at OAC 3701-4-1. It includes sections on definitions, reporting, and confidentiality of data and availability of data to researchers. Ohio’s program is similar to Indiana’s, except that Ohio gives a cancer hospital and research institute reporting responsibility. Idaho – Idaho statute at Idaho Code § 57-1701-1707 establishes funding and general provisions for the Idaho cancer registry, including a grant of immunity for reporters unless unauthorized disclosure is due to gross negligence or willful misconduct. References in Idaho Administrative Code are woven into the chapter on Idaho Reportable Diseases and Control Measures, IDAPA 16.02.10. IDAPA 16.02.10.170 addresses reporting requirements to the Cancer Data Registry of Idaho. Idaho administrative code combines cancer registry-specific information within the broader subject of reportable diseases. South Dakota – The South Dakota central cancer data collection system is established by South Dakota statute at S.D Codified Laws § 1-43-11 through 13. All details about the program are contained in administrative code at ARSD 44:22:01 through 44:22:05. Sections include definitions, organization and structure, and functions; required reporters, reportable conditions (broken down into specific subchapters); corrections, validation, and editing of data; and confidentiality, publication, research, and reporting of data. The reporting scheme for the South Dakota cancer registry has been unchanged since 2005. Paper reporting is allowed (although electronic reporting is encouraged), and if a facility is unable to comply with reporting procedures, the facility can submit patient records to the SD Department of Health (SDDOH) for completion. The SDDOH is authorized to audit reporting facilities. The registry has incorporated the reporting standards of the North American Association of Central Cancer Registries (NAACCR) into its administrative rules. While South Dakota has a small population compared to Indiana, it has a significant portion of AIAN (American Indian and Alaska Native) residents; the SDDOH works with Indian Health Service (HIS) and tribal organizations to reduce racial misclassification of AIAN residents. This is an area of increased focus for South Dakota that is not present in Indiana. Overall, South Dakota’s regulatory scheme is more restrictive than Indiana’s.

II. Rationale for the Continued Need for the Rule 

There is a continued need for testing during the artificial insemination process to protect the people being inseminated and infants. The program that oversees the artificial insemination rule still exists, and intended benefits are still being obtained. Expenses for regulated entities performing artificial inseminations should be minimal and routine. A study from 1995 concluded that infection with HIV through donor artificial insemination performed before routine HIV screening of semen donors represents a potentially serious threat to individuals who underwent artificial insemination. Requiring testing of donor semen does not restrict donation and artificial insemination, thereby achieving the regulatory goal in the least restrictive manner. 410 IAC 25 does not duplicate standards found in other state or federal laws. The rule is simple and written for ease of comprehension. Enforcement is practicable. IDOH has not identified any alternatives.

IX. Other State or Federal Requirements

Illinois regulates through administrative rule requiring donor testing for HIV and any other causative agent for AIDS for sperm and tissue.77 IL Admin Code § 470.40. Indiana requires a broader test panel and quarantine period than Illinois. Illinois has a state registry for sperm/tissue banks, Indiana only focuses on practitioner duties and testing/record rules. Kentucky regulates through statute, KRS 311.281. Kentucky’s statute requires, “[t]esting of organs, skin, or other human tissue for HIV and other communicable diseases, with informed consent,” but does not explicitly state “sperm” or “semen” are required to be tested. There is no definition of “other human tissue” but it is read to include donated semen. The statute requires testing for “other communicable diseases specified by the … American Association of Tissue Banks….” The American Association of Tissue Banks includes guidance for sperm and semen (reproductive) tissue on its website. Kentucky requires the federal testing requirements. Michigan’s statute is found at MCL 333.16273. Michigan is less restrictive than Indiana because it only tests for HIV and does not require ongoing testing or recipient testing. Indiana’s rule is more comprehensive by addressing a wider range of infectious diseases and more rigorous testing protocols. Ohio: Ohio’s statute does not require testing unless frozen semen is being used and the physician involved in the non-spousal artificial insemination considers the testing appropriate. The laboratory studies may include, but are not limited to, venereal disease, karyotyping, GC culture, cytomegalo, hepatitis, Kem-zyme, Tay-Sacks, sickle cell, Ureaplasma, HLTV-III, and chlamydia. ORC 3111.91. Ohio is less restrictive than Indiana because testing is at the discretion of the physician. It does not specify mandatory testing for infectious diseases or impose a quarantine period for fresh semen specimens regardless of marital status. Indiana rule with quarantine periods maximizes recipient safety because some diseases take time to manifest. The Indiana rule also protects offspring, mitigates legal risks, and provides quality assurance and standardization. Idaho: Idaho’s statute is found at Idaho Code 39-54. Idaho only requires testing for HIV. Idaho does not require a quarantine period or retesting. South Dakota: South Dakota does not have a rule or a statute. Federal: Testing is required for HIV, Hepatitis B, C, and Treponema pallidum. 21 CFR Part 1271. There is some overlap between the federal regulation and Indiana’s program, but Indiana requires testing for additional STIs. Indiana has a higher rate of congenital syphilis among other STIs so additional testing beyond the federal requirements protects Indiana residents from the elevated risk. This additional testing is only required when the donor and recipient are not in a mutually monogamous relationship and the risk is higher.

II. Rationale for the Continued Need for the Rule 

410 IAC 29 provides a set of rules and guidelines needed to assist children affected by lead exposure. When elevated lead levels are reported to the state, the program established by the rule provides case management. Lead is a neurotoxin and irreparably impacts brain development in young children. Lead exposure can lead to negative health outcomes for any child, and there are no safe levels of lead in a child’s body. Children exposed to low levels can suffer a 5-point loss in IQ, brain and nervous system damage, slowed growth, hearing problems, and headaches. This rule allows IDOH to support affected families around the state, provide education on lead sources and impacts, and improve Indiana’s ability to manage lead exposure within the residential environment. There is not a less costly/intrusive way to ensure families receive the necessary support. This rule does not apply to small businesses. Families always can opt out of the services offered, so there is not an obligation to families to accept state resources. Most, if not all, pediatricians test lead levels as a part of well-child visits. The rule is written for ease of comprehension and enforcement is practicable. IDOH is well equipped to administer the rule and work closely with local health departments.

V. Alternative Methods of Achieving the Purpose of the Rule-

There is not a less costly/intrusive way to ensure families with children are receiving the necessary support to protect against the harm of lead exposure.

IX. Other State or Federal Requirements

IDOH sets intervention levels based on the federal requirements with the local health department intervention being based on the severity of the case. While Indiana has interventions at lower levels, it is minimal to be less costly while still providing the families of children at risk with information to help prevent the levels from worsening. Illinois: Illinois is the same to slightly stricter by way of an administrative Rule. Illinois Lead Prevention Act 410 ILCS 45 & Illinois Lead Poisoning Prevention Code 77 IL. Admin Code 845. Illinois has stricter timelines for reporting and confidentiality safeguards. Illinois complements testing with licensing for environmental lead professionals. Kentucky: Kentucky’s program features a statute and administrative rule like Indiana, except Kentucky has a lower statutory reporting trigger than Indiana for case management. Kentucky Revised Statutes 211 & Kentucky Administrative Rules 486. Michigan: Michigan is the same as Indiana except case management starts at 3.5 micrograms per deciliter versus 5 in Indiana. Testing is required for children older than six if they fall into any of the high-risk categories. Michigan Compile Law 333.5474d & Michigan Administrative Code R 330.301, R 330.302, R 330.303, and R 330.304 Ohio: Ohio Administrative Code, Chapter 3701-30. Ohio is the same as Indiana except case management starts at 3.5 micrograms per deciliter. Idaho: The Idaho rule that requires reporting, and not much by way of further action is required to be done once the levels are reported. Indiana’s rule is stricter because Indiana has an interest in reducing blood lead levels. Idaho’s rule states that each reported case of lead poisoning or excess lead exposure may be investigated to confirm blood lead levels, determine the source, and whether actions need to be taken to prevent additional cases. The Idaho Health Department may investigate; the rule doesn’t require it. According to the CDC, childhood lead poisoning is still considered to be the most preventable environmental disease of young children. Yet an estimated 450,000 children in the United States have elevated blood lead levels (EBLL’s) >5µg/dL. Lead poisoning, a BLL of >15µg/dL can affect nearly every system in the body. A simple early childhood screening blood test can help to prevent a lifetime of irreversible adverse effects on the body. South Dakota: South Dakota requires reporting as of January 1, 2025. South Dakota has screening, testing, and follow-up guidelines. https://doh.sd.gov/laboratory/medical-microbiology-testing/blood-lead-testing/. South Dakota does not have specified reporting timelines or enforcement penalties. Federal: The EPA sets standards and has recommended actions based on lead levels. https://www.epa.gov/lead/lead-regulations#paint & https://www.hudexchange.info/programs/lead-based-paint/

II. Rationale for the Continued Need for the Rule 

There is a continued need for 410 IAC 34, implementing the STR. The registry was established in 2006 with the passage of IC 16-19-3-28. The citizens of Indiana rely on IDOH to coordinate and lead the statewide trauma care system, of which the registry is an important part. Readoption of 410 IAC 34 will continue to have the same impact on regulated entities, e.g., the hospitals, trauma centers, rehabilitation hospitals, and EMS providers, that are mandated reporters. Persons who pay taxes or fees for government services are not affected by the rule, nor are consumers of products and services of regulated entities affected by the rule. 410 IAC 34 achieves the regulatory goal of implementing the STR. The administrative rule supports the collection and analysis of trauma related data to evaluate the delivery of trauma care. The goal of the registry is to improve outcomes for injured patients. It details which facilities are required to report what information into the registry. It also prescribes a reporting schedule and provides how confidential data is protected and shared when appropriate with researchers. 410 IAC 34 is written for ease of comprehension in that it is organized into topics by section. Sections include definitions, the purpose of the registry, management of the registry, required reporting, submission of data, reporting deadlines, failure to report, risk adjustment, and protected information. Enforcement of the rule at 410 IAC 34-7-1 provides that reporters failing to submit data to the registry will be ineligible for designation by IDOH as a trauma center and the receipt of grants and other IDOH-sponsored sources of funding.

III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6 

There are no fees, fines, or civil penalties for reports to the STR. However, pursuant to 410 IAC 34-7-1, health care facilities that fail to submit data to the registry as specified will be ineligible for designation by IDOH as a trauma center and the receipt of grants and other IDOH-sponsored sources of funding.

V. Alternative Methods of Achieving the Purpose of the Rule

To collect high quality data and drive performance improvement, IDOH must maintain a trauma patient registry. The current fiscal impact of maintaining the trauma registry is low – around $62,000 annually to support ongoing data collection and necessary analysis. Other available healthcare data sources, i.e., administrative claims data, do not include sufficient data to accurately monitor trauma system performance and support quality improvement. IDOH continues to discuss adding hospital registrar support (training, education, and possibly contractors) and statewide automation for registry submission as future enhancements to the registry. The information in 410 IAC 34 must be contained in statute or rule. 410 IAC 34 should be readopted until such time as its provisions are enacted as statutes.

IX. Other State or Federal Requirements

While there are no federal regulations for state trauma registries, the American College of Surgeons (ACS) has established standards and guidelines for trauma centers and registries. Indiana follows the National Trauma Data Standard (NTDS), which are set on an annual basis by the ACS. Indiana is in compliance with NTDS, as are Illinois and Michigan. Kentucky requires participation in its trauma registry from trauma centers only, whereas in Indiana, the following are mandatory reporters: hospitals with emergency rooms, trauma centers, rehabilitation hospitals, and both basic and advanced life support EMS service providers. Ohio’s registry also is limited to trauma centers. Idaho repealed its trauma registry statute this year and does not have any hospitals that are designated trauma centers. South Dakota’s scheme is similar in scope to Indiana’s and is designed to be compliant with the NTDS. The main difference between Indiana and South Dakota’s trauma registry scheme is that South Dakota strictly prohibits the sharing of confidential information from its trauma registry for research purposes, whereas Indiana’s does allow for such exchange with proper safeguards; otherwise, the two states are similar in terms of mandatory reporters and adherence to NTDS standards. Illinois – Illinois Administrative Code §515.2050 (found in Title 77 of the code) requires each trauma center to have specific computer equipment and for the Illinois Department of Health to provide software. Reports are to be made quarterly. The code specifies the data fields to be reported, states which types of patients and accidents must be reported and mandates the department to draft a deidentified annual report. Requirements for the release of confidential data for research are listed, along with the type of agreements. Registry data is not subject to public records request. The department may access hospital information for two years. The Illinois administrative code covering the trauma registry is found in the section on trauma centers. It is more prescriptive than Indiana’s rule in terms of the equipment that must be used by each trauma center. Additionally, it requires each hospital to provide the Illinois Department of Health with access to all hospital records related to registry information for cases that have been open for less than two years. Kentucky – Kentucky statute at KRS 211.494 provides for a statewide trauma care system with a trauma care director and registrar. The Kentucky Trauma Registry and Data Bank System (KTDB) is established by 902 KAR 28:040. Each trauma center must keep a trauma registry and upload data quarterly to the KTDB electronically maintained by the Kentucky Department of Public Health. Data in the registry is considered protected health information (PHI). The Kentucky registry requires only trauma centers to submit data to the KTDB. Michigan – Michigan’s statewide trauma registry is found at Mich. Admin. Code R 325.134 Rule 10. The registry is organized under the Michigan Department of Public Health to collect and analyze trauma system data. The department is responsible for incorporating data elements and definitions, methods for submitting data, timetables, formats, and protections for confidentiality of records. Facilities must submit data, and the department and regional advisory councils use the data in reports and analyses. Michigan’s rule is like Indiana’s, except that Michigan adds regional advisory councils to the program. Ohio – Ohio’s trauma system registry is found at Chapter 4765-4 of the Ohio Administrative Code. The chapter includes sections with definitions, purpose, required reporting, risk adjustment, protected information, submission of data, deadlines for reporting, consequences for failure to report, and provision for regional (as opposed to statewide) reporting. Ohio’s rule is like Indiana’s, except that Ohio provides for a system of regional reporting. Idaho – According to legislative information, the Idaho trauma registry (originally enacted in October 2005) was repealed effective July 1, 2025. Note: Idaho’s only trauma center lost certification from the American College of Surgeons in December 2023. South Dakota – S.D. Codified Laws § 34-12-53 directs the South Dakota Department of Health to “develop, implement, and administer a trauma care system including a statewide trauma registry that involves all hospitals, freestanding medical care facilities, rural emergency hospitals, and emergency medical services within the state.” Two sections of administrative rules have been passed, ARSA 44:68:04:01 defining reporting duties, timelines, and methods (electronic or paper) and ARSA 44:68:04:02 providing that trauma registry data is “strictly confidential medical Information” which cannot be shared, made public, or made subject to subpoena or made admissible as evidence. Nonidentifiable information can be made public by the department for statistical purposes.

II. Rationale for the Continued Need for the Rule 

The need to promote human health by ensuring that properties previously used for illegal controlled substance manufacturing are properly evaluated, decontaminated, tested, and deemed fit for re-occupancy still exists. There are still benefits to the Rule. Testing and remediation are the only and therefore the most effective methods for achieving the rule's purpose. There are no alternative methods to correct the problem, and the rule does not impose any unnecessary expenses on impacted parties. 410 IAC 38 applies to entities that test and remediate controlled substance contamination, owners of contaminated properties, and counties that take possession of a contaminated property in accordance with Indiana law. The rule does not duplicate Federal requirements; it is written for ease of comprehension, and its enforcement is practicable.

IX. Other State or Federal Requirements

The states that are less restrictive than Indiana are ones that have no rules or statutes. Indiana statute requires IDOH to regulate this area so IDOH could not be at the same level of regulation as those states. Illinois does not have any rules or statutes. Kentucky: Kentucky has a statute and a rule. Kentucky’s laws are more stringent than Indiana’s because the contamination threshold that must be met is lower in Kentucky. Indiana has less formalized disclosure or enforcement mechanisms. Indiana’s primary focus is on IDOH oversight through certification, while Kentucky has formal contamination disclosure requirements and penalties (including criminal) for nondisclosure. (https://eec.ky.gov/Environmental-Protection/Waste/superfund/methamphetamine-lab-cleanup/Pages/default.aspx) Michigan does not have any specific statutes or rules. Ohio does not have any specific statutes or rules. Idaho: Idaho has a statue and a rule. IDAPA 16.02.24 - Rules for Clandestine Drug Laboratory Cleanup. Idaho has a stricter contamination threshold than Indiana and encourages voluntary compliance by offering immunity once proper cleanup is confirmed. Idaho places more of an emphasis on disclosure than Indiana. That is probably because the Indiana State Police maintains Indiana’s list of contaminated properties. In Idaho there is no state licensing, but the cleanup must be certified by qualified industrial hygienists. Indiana requires a certified cleaner; Idaho allows self-cleanup. It is not safe to be exposed to the chemicals, so Indiana’s rule makes sure that the people exposed during the clean-up process are properly trained to reduce health problems that result from being exposed to the chemicals used in illegal drug manufacturing. South Dakota: South Dakota has guidelines only. It has no statewide law that requires cleanup of meth labs, that stipulates the type of training or equipment required of those who clean them, or that provides oversight. Federal: In October 2009, the U.S. Environmental Protection Agency (USEPA) released Voluntary Guidelines for Methamphetamine Laboratory Cleanup. These guidelines are based on an extensive review of the best available science and practices for cleanup. The federal guidance does not have a specified residue limit, require certifications for cleanup and testing professionals, or detail sampling methods. The Indiana rule includes more requirements to achieve uniform results which the federal guidelines lacked.

I. Statement Whether the Subject Matter Covered by the Rule Remains Carried out by the Agency

IDOH continues to certify obstetric and neonatal hospitals and birth centers in Indiana pursuant to 410 IAC 39-1. IC 16-21-13-5 gives IDOH the authority to pass administrative rules to implement the chapter on Perinatal Hospital Servies, which “may include regulation of interfacility patient transfers.”

II. Rationale for the Continued Need for the Rule 

There is a continued need for 410 IAC 39-1. Along with definitions, the rule covers levels of care certification, birth center requirements, obstetrical and neonatal levels of care requirements, obstetrical and neonatal universal standards, transport requirements, perinatal centers and matters incorporated by reference. There are four levels of licenses for obstetric and neonatal facilities, with Level 1 facilities providing the most basic services and Level IV facilities providing the most complex services and augmented staffing requirements. The requirements for licensing under the rule are detailed and cumulative. The rule runs for twenty pages and would make for a very long statute. Readoption of 410 IAC 39-1 will continue to have the same impact on regulated entities, which are various birth-related facilities and transport organizations. The rule does not have a direct impact on persons who pay taxes or fees for government services or for the consumers of products and services affected by the rule. 410 IAC 39-1 achieves the regulatory goal of creating clear requirements for the four levels of obstetric and neonatal facilities in the least restrictive manner possible in what is a highly regulated area. 410 IAC 39-1 is written for ease of comprehension to the greatest extent possible given that it regulates highly complex entities. Within the rule, the requirements for levels of facilities are cumulative and consistent. 410 IAC 39-1 does not contain any fees, fines, or civil penalties.

III. Analysis of fees, fines, and civil penalties under IC 4-22-2-19.6

There are no fees, fines, or civil penalties for reports to IDOH pursuant to this rule; fees are referenced in the license application fee but not memorialized in the rule or governing statute.

IV. Cost-Benefit, Economic Impact, Fiscal Impact, or Regulatory Burden Statements

The following revisions are relevant to the previously published economic impact statement: 1. Estimate of the number of small businesses, classified by industry sector, that will be subject to the proposed rule: Revision: There are now seven birthing centers and seventy-five delivering hospitals that are subject to 410 IAC 39-1. 2. Estimate of average annual reporting, record keeping, and other administrative costs that small businesses will incur to comply with the proposed rule: Revision: Birth centers need to provide proof of re-accreditation within three months after the three-year expiration date; all of the birth centers are compliant with this requirement. Licensing fees for birthing centers are based on the number of births per year for the center, see 410 IAC 15-5. The economic impact statement published in the Indiana Register on January 24, 2019: https://www.in.gov/health/files/Small-Business-Economic-Impact-Statement-IR-18-416-2.pdf.

V. Alternative Methods of Achieving the Purpose of the Rule

IC 16-21-13 directs IDOH to establish a certification program based on American College of Obstetricians and Gynecologists (ACOG) and American Academy of Pediatrics (AAP) standards. IC 16-21-13-1 disconnects the perinatal certification from other licensure actions. To achieve the purpose of the rule by alternative methods, the legislature would need to modify IC 16-21-13.

VI. Complaints and Comments

During the surveying process for Perinatal Levels of Care, the state underwent significant changes that impacted clinical practices, particularly due to the Covid-19 pandemic. Consequently, existing regulations have become misaligned with their original objectives. Initially, these rules allowed limited telehealth services and required emergency department staff to ask patients about their pregnancy status within the past twelve months. This rigidity has highlighted the need to reevaluate guidelines to better meet the evolving needs of patients and healthcare providers. IDOH is in the process of updating 410 IAC 39.

VII. Difficulties Encountered 

IDOH has not encountered any difficulties administering the rule and is not aware of any difficulties faced by hospitals and birth centers in complying with the rule.

VIII. Changes in Technology, Economic Conditions, or Other Factors 

The increased use of telehealth services since the implementation of these standards represents a technological change in how healthcare services are delivered. These rules provided minimal provisions for telehealth services and instituted a stringent protocol in emergency departments mandating that staff inquire about a patient’s pregnancy status within the past twelve months. This lack of flexibility in adapting to new healthcare delivery methods has highlighted the need for a re-evaluation of these guidelines to better meet the evolving needs of patients and healthcare providers; however, such a re-evaluation is beyond the scope of rule readoption.

IX. Other State or Federal Requirements

Comparison between Indiana and other states surveyed: Illinois locates perinatal and neonatal levels of care in separate chapters of administrative code. Its rule is more stringent than Indiana’s in terms of its application process and the time limit of 30 minutes for facilities to provide critical services (Indiana focuses on services available at a facility). Michigan and Ohio have comparable programs to Indiana’s, with Michigan’s program found in statute and Ohio’s in administrative code. Kentucky, Idaho, and South Dakota do not have programs that regulate perinatal care in four levels but regulate perinatal services with hospitals. These states regulate alternative birth centers and services provided by certified midwives separately. Federal Regulations –N/A. Illinois – 20 ILCS 2310/2310-223 Maternal Care. The statute includes only maternal (and not neonatal) levels of care. The four levels are designated as basic, specialty, subspecialty, and regional perinatal care. Illinois standards are not required to conform with ACOG or AAP, but the statute requests that the state department work with the Illinois chapter of the AAP.  The rule was passed in 2019 and updated in 2022 (stylistic change). 77 Ill. Admin. Code 640 et seq. includes neonatal levels. The Illinois code includes specific 30-minute time limits to provide critical services as opposed to the “availability” language in Indiana’s code. The code requires facilities to submit an application, plan, letter of agreement, and recommendation of department program staff, whereas Indiana just requires an application showing the facility meets the criteria for the level sought; Illinois’ certification process is more intensive. Illinois also does an onsite survey and licenses are reviewed every three years. Kentucky – A new statute establishing freestanding birthing centers just became effective on March 28, 2025, through Kentucky House Bill 90. The statute was created under KRS 216B. The statute sets out the requirements for low-risk birth centers that must be located within 30 miles of a hospital that provides obstetric services with which it has a transfer agreement. Kentucky previously had established an administrative rule for Alternative Birth Centers to provide perinatal care for low-risk pregnancies at 902 KAR 20:150. Michigan – MCLS § 333.9129 provides for the registration of perinatal facilities as maternal care facilities, broken down into levels I through IV. The Michigan Department of Health is directed to “establish procedures for a perinatal facility to report a verification described in this subsection” every three years. The program is to follow ACOG guidelines. MCLS § 333.9130 directs the department to establish and maintain regional perinatal quality collaboratives in ten “prosperity regions” throughout the state. Michigan does not have administrative rules regarding perinatal care. Ohio – Ohio regulates perinatal care at OAC Ann. 3701-7; there are no statutes covering perinatal care. 3701-1 covers definitions, licensing, inspections, facility and equipment requirements, Level I through IV standards, neonatal care standards, administrative requirements, and waivers. Application fees range from $250 - $750, and inspection fees range from $750 to $3,750. Ohio allows for a variance or waiver from any requirements and does an onsite survey with review every three years. Idaho – Idaho does not provide for perinatal services or levels of care by statute or administrative rule; the only place the term perinatal comes up in Idaho law is regarding licensing of midwifes. South Dakota – South Dakota does not provide for perinatal services or levels of care by statute or administrative rule; routine perinatal care is provided for in the professional standards for certified professional midwifes at SDAC 20:86:03:10.

X. Previous Amendments

410 IAC 39 was enacted in September 2019 following a detailed analysis of birthing facilities and hospitals in Indiana and has not been amended.

XI. Integration into Indiana Code

Administrative rules implementing hospital and other health care facility licensing schemes are some of the most detailed and lengthy impacting entities regulated by IDOH. Given the length and detail of the rule, and because there are ongoing changes in the methods of delivery of health services (e.g., rise of telehealth) and the standards for licensure as a perinatal facility are based on those set by ACOG and AAP, it would be difficult to convert the rule into statute.

XII. Contact Information of Staff to Answer Substantive Questions

Ann Z. Knotek, Staff Attorney, Indiana Department of Health. (317) 233-7874; aknotek@health.in.gov Notice of Public Comment Period for Rule Readoption: 20250910-IR-410240588RNA Notice of Determination Received: August 27, 2025