reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-1 - License

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC
				  4-21.5-3-5;
				  IC 16-21-2
Sec. 1.
(a) A
				license must be obtained from the commissioner under IC
				4-21.5-3-5
				before:
(1) establishing;
(2) conducting;
(3) operating; or
(4) maintaining; an abortion clinic. An
				abortion clinic may not operate without a license issued by the
				commissioner.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-2 - Preoccupancy inspection

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a) The
				department will not issue a provisional license to operate an abortion clinic
				until the clinic has passed a preoccupancy inspection by the
				department.
(b) Once a new
				construction, addition, or renovation of an abortion clinic is complete, the
				abortion clinic must notify the department that the clinic is ready for
				occupancy. The department will then schedule and perform a preoccupancy
				inspection. The preoccupancy inspection is to determine compliance of the
				abortion clinic with
				410 IAC 26-17-1
				and
				410 IAC
				26-17-2.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-3 - Application for initial license

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 3.
(a) To
				obtain a license to operate an abortion clinic, an application for a license to
				operate an abortion clinic must be submitted to the division. At the latest,
				however, the application must be received by the department at least forty-five
				(45) days before the anticipated opening of the clinic. At least forty-five
				(45) days before the opening of the clinic, the applicant must inform the
				division of the anticipated date of opening.
(b) The initial license application includes
				the following:
(1) An application for a
				license to operate an abortion clinic on a form prescribed by the division to
				include the selection of only one (1) of the following procedure
				classifications:
(A) Surgical abortions only.
				The clinic is precluded from performing drug induced abortions.
(B) Both drug induced abortions and surgical
				abortions. The clinic must comply with this article and 410 IAC 26.5.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-4 - Review and approval of initial license application

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC
				  16-21-2-11
Sec. 4.
(a) Upon
				receipt of a completed application for an abortion clinic license, the
				department will review the application and accompanying documentation to
				determine that the applicant has met the requirements of IC
				16-21-2-11(a)(1)
				 and IC
				16-21-2-11(a)(2).
(b) Upon determination by the commissioner
				that the applicant has failed to comply with this article, the commissioner
				may:
(1) request additional information
				concerning the application;
(2)
				conduct a further investigation to determine whether a provisional license
				should be granted; or
(3) deny the
				application.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-5 - Denial of license

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2; IC 27-13-1
Sec. 5.
The commissioner may deny a license to operate an abortion
				  clinic for any of the following reasons:
(1) If the licensee or licensees are not of
				reputable and responsible character.
(2) If the abortion clinic is not in
				compliance with the minimum standards for an abortion clinic adopted under this
				article.
(3) For violation of any
				of the provisions of IC 16-21 or this article.
(4) For permitting, aiding, or abetting the
				commission of any illegal act in the clinic.
(5) For knowingly collecting or attempting to
				collect from:
(A) a subscriber (as defined in
				IC
				27-13-1-32
				); or
(B) an enrollee (as defined
				in IC
				27-13-1-12
				);
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-6 - Renewal of license

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 6.
(a) In order
				to renew its abortion clinic license, the clinic shall file an application for
				the renewal of an abortion clinic license with the division at least one (1)
				month before the expiration of the current license.
(b) The renewal application includes the
				following:
(1) An application for the renewal
				of a license to operate an abortion clinic on a form prescribed by the division
				to include the selection of only one (1) of the following procedure
				classifications:
(A) Surgical abortions only.
				The clinic is precluded from performing drug induced abortions.
(B) Both drug induced abortions and surgical
				abortions. The clinic must comply with this article and 410 IAC
				26.5.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-7 - Posting of license

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 7.
A license issued under this article must be conspicuously
				  posted on the premises in an area open to patients.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-8 - Enforcement actions

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-2; IC 16-21-3; IC 27-13-1
Sec. 8.
(a) The
				commissioner may take any of the following actions on any of the grounds listed
				in subsection (b):
(1) Issue a letter of
				correction.
(2) Issue a
				probationary license.
(3) Conduct a
				resurvey.
(4) Deny the renewal of a
				license.
(5) Revoke a license.
(6) Impose a civil penalty in an
				amount not to exceed ten thousand dollars ($10,000).
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 2 - License Requirements › Section 2-9 - Probationary license

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 4-21.5; IC 16-21
Sec. 9.
A probationary license may be:
(1) issued for a period of three (3) months;
				and
(2) reissued;
but no more than three (3) probationary licenses may be
				  issued during a twelve (12) month period. The issuance of a probationary
				  license results in the automatic expiration of any other license held under
				  this article.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 3 - MATERNAL AND CHILD HEALTH › Section 3-1 - Survey procedures

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC
				  16-21-2-6
Sec. 1.
(a) The
				abortion clinic shall fully cooperate with surveys conducted by representatives
				of the department. Upon arrival of department surveyors at the clinic, the
				clinic may immediately contact the department to confirm the identity of the
				surveyors. Upon confirmation by the department of the survey and surveyors, the
				clinic shall:
(1) immediately admit the
				surveyors to the clinic; and
(2)
				not delay the survey.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 3 - MATERNAL AND CHILD HEALTH › Section 3-2 - Licensing surveys

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a) The
				department will conduct a licensing survey of each abortion clinic at least one
				(1) time per calendar year. The licensing survey is conducted to ensure that
				the abortion clinic is operating in compliance with state law.
(b) Licensing surveys will be conducted
				during normal business hours of the abortion clinic unless the abortion clinic
				requests that the survey be conducted during nonbusiness hours.
(c) The division will notify the clinic of
				the results of the licensing survey in writing.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 3 - MATERNAL AND CHILD HEALTH › Section 3-3 - Complaint surveys

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 3.
(a) In
				accordance with division policy, the division shall investigate credible
				complaints received by the division that allege noncompliance with this
				article.
(b) Complaints will be
				assigned a priority for investigation in accordance with division
				policy.
(c) A licensing survey may
				be conducted simultaneously with and in addition to a complaint
				survey.
(d) The division shall
				notify the abortion clinic of the results of the complaint survey in writing.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 3 - MATERNAL AND CHILD HEALTH › Section 3-4 - Plan of correction

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 4.
(a) The
				abortion clinic must file an acceptable plan of correction with the division
				within ten (10) days of receipt of a survey report from the division that
				documents noncompliance with state law.
(b) Unless the commissioner determines that
				there is a need for immediate release, the abortion clinic will have ten (10)
				days after notification of a noncompliance to submit to the division an
				acceptable plan of correction before the survey report is made available to the
				public.
(c) The plan of correction
				shall contain, for each deficient practice cited on the survey report, at least
				the following:
(1) How the deficient practice
				will be corrected.
(2) How the
				deficient practice will be prevented from reoccurrence.
(3) Who will be responsible for correction
				and prevention.
(4) The month, day,
				and year that the corrective action will be completed, not to exceed thirty
				(30) days from receipt of the notice of noncompliance.
(5) If the nature of the corrective action
				requires more than thirty (30) days from the date of receipt of the notice of
				noncompliance, the clinic shall submit justification and a completion date to
				the division .
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 3 - MATERNAL AND CHILD HEALTH › Section 3-5 - Confidentiality

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 5.
The department shall maintain the confidentiality of patient
				  identities, patient information, and patient records.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 4 - Governing Body › Section 4-1 - Powers and duties

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2; IC 16-34; IC 25-22.5
Sec. 1.
(a) The
				governing body:
(1) shall function as the
				ultimate authority; and
(2) is
				responsible for the conduct and management; of the abortion clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 4 - Governing Body › Section 4-2 - Appointment and conduct of medical staff

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a) The
				medical staff of the clinic:
(1) consists of
				physicians appointed to or contracted with to provide medical services at the
				clinic; and
(2) must be composed of
				at least one (1) physician.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 5 - Administration and Policies › Section 5-1 - Administration

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
The clinic administrator is responsible for day-to-day
				  operations of the abortion clinic to include, but not be limited to, the
				  following functions:
(1) Employing
				qualified staff:
(A) commensurate with
				assigned duties and responsibilities; and
(B) in accordance with the employee's:
(i) licensure;
(ii) certification;
(iii) experience; and
(iv) competence.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 5 - Administration and Policies › Section 5-2 - Required policies and procedures

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a) The
				clinic shall develop, implement, and maintain the following:
(1) Written medical staff policies.
(2) Written procedures for the following:
(A) Emergencies.
(B) Initial treatment.
(C) Transfer.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 6 - Quality Assessment and Improvement › Section 6-1 - Quality assessment and improvement

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				abortion clinic must develop or adopt, implement, and maintain an effective,
				organized, clinic-wide, comprehensive quality assessment and improvement
				program in which all areas of the clinic involved in the provision of surgical
				abortion participate. The program shall be ongoing and have a written plan of
				implementation that evaluates, but is not limited to, the following:
(1) All services, including services
				furnished by a contractor.
(2) All
				functions, including, but not limited to, the following:
(A) Discharge.
(B) Transfer.
(C) Infection control.
(D) Response to patient
				emergencies.
(3) All
				services performed in the clinic with regard to the following:
(A) Appropriateness of diagnoses and
				treatments related to a standard of care.
(B) Anticipated or expected
				outcomes.
(4) Medical
				and medication errors.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 6 - Quality Assessment and Improvement › Section 6-2 - Reportable events

Current through July 10, 2024
Authority: IC
				  16-19-3-4;
				  IC
				  16-21-1-7
Affected: IC 16-19-3; IC 16-21-1; IC 25
Sec. 2.
(a) The
				clinic's quality assessment and improvement program under section 1 of this
				rule shall include the following:
(1) A
				process for determining the occurrence of the following reportable events
				within the clinic:
(A) The following surgical
				events:
(i) Surgery performed on the wrong
				body part, defined as any surgery performed on a body part that is not
				consistent with the documented informed consent for that patient. Excluded are
				emergent situations:
(AA) that occur in the
				course of surgery; or
(BB) whose
				exigency precludes obtaining informed consent; or both.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 7 - Medical Records › Section 7-1 - Medical records, storage, and administration

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				abortion clinic must do the following:
(1)
				Create and maintain a medical record on each surgical abortion
				patient.
(2) Have a written policy
				that ensures responsibility for and maintenance of surgical abortion records as
				follows:
(A) The clinic must establish and
				implement the following:
(i) Policies and
				procedures to assure that the care and services provided to each patient are
				appropriately documented.
(ii) A
				system to assure that medical records are readily available in accordance with
				clinic policy and systematically organized to facilitate the compilation and
				retrieval of information.
(B) The policy must provide safeguards to
				assure protection of the medical records from the following:
(i) Fire.
(ii) Water.
(iii) Other sources of damage.
(C) All original medical records
				or legally reproduced medical records must be maintained by the clinic for a
				period of at least seven (7) years or the applicable statute of limitation,
				whichever is longer. Original medical records must be maintained in the clinic
				for at least two (2) years. Records over two (2) years old may be kept off-site
				but must be retrievable within forty-eight (48) business hours.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 7 - Medical Records › Section 7-2 - Content of the medical record

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2; IC
				  16-34-2-1.1
Sec. 2.
(a) The
				medical record for surgical abortions must be accurate and contain sufficient
				information to do the following:
(1) Identify
				the patient to include name, age, and address.
(2) Document the following:
(A) Tests, examinations, and procedures
				performed.
(B) The course of the
				patient's stay in the clinic and the results.
(C) Evidence that the patient was provided
				the hotline telephone number for assistance to patients who are:
(i) coerced into an abortion; or
(ii) victims of sex
				trafficking.
(D) Evidence
				of appropriate informed consent for procedures and treatments as required by IC
				16-34-2-1.1.
(E) Any report filed with a state agency or
				law enforcement agency pursuant to a statutory reporting
				requirement.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 8 - Personnel › Section 8-1 - Personnel policies and records

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				abortion clinic shall maintain current and accurate personnel records for all
				employees. Personnel records shall:
(1) be
				maintained for each employee of the clinic; and
(2) include personal data to include:
(A) education;
(B) experience;
(C) date of employment;
(D) a copy of current license when
				required;
(E) evidence of
				participation in job-related educational and training activities; and
(F) health records of employees that relate
				to post offer and subsequent:
(i) physical
				examinations;
(ii) tests;
				and
(iii) immunizations.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 8 - Personnel › Section 8-2 - Employee health monitoring

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
The clinic shall do the following:
(1) Develop, implement, and maintain a
				written policy for the control of communicable disease in compliance with
				applicable federal and state laws.
(2) Monitor employee health in accordance
				with the clinic's infection control program.
(3) Ensure that all employees, staff members,
				and contractors having direct patient contact are evaluated at least annually
				for tuberculosis as follows:
(A) Any person
				with a negative history of tuberculosis or a negative test result must have a
				baseline two-step tuberculin skin test using the Mantoux method or a
				quantiferon-TB assay unless the individual has documentation that a tuberculin
				skin test has been applied at any time during the previous twelve (12) months
				and the result was negative.
(B)
				The second step of a two-step tuberculin skin test using the Mantoux method
				must be administered one (1) to three (3) weeks after the first tuberculin skin
				test was administered.
(C) Any
				person with a documented history of tuberculosis, documented previously
				positive test result for tuberculosis, documented completion of treatment for
				tuberculosis, or newly positive results to the tuberculin skin test must have
				one (1) chest radiograph to exclude a diagnosis of tuberculosis.
(D) After baseline testing, tuberculosis
				screening must be completed annually and must include at a minimum a tuberculin
				skin test using the Mantoux method or a quantiferon-TB assay unless the
				individual was subject to clause (C).
(E) Any person having a positive finding on a
				tuberculosis evaluation may not work in the abortion clinic or provide direct
				patient contact unless approved by a physician to work.
(F) The abortion clinic must maintain
				documentation of tuberculosis evaluations showing that any person working for
				the abortion clinic or having direct patient contact has had a negative finding
				on a tuberculosis examination within the previous twelve (12) months.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 8 - Personnel › Section 8-3 - Orientation and training requirements

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 3.
(a) The
				clinic must do the following:
(1) Develop,
				implement, and maintain a policy and procedure for the orientation of new
				employees, contractors, and agency personnel providing direct care and services
				to patients.
(2) Orientate all new
				employees, including contract and agency personnel, to applicable clinic and
				personnel policies.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 9 - Medical Staff › Section 9-1 - Medical staff services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				medical staff of the clinic is:
(1)
				accountable to the governing body of the clinic; and
(2) responsible to the governing board for
				the quality of medical care and services provided to patients.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 10 - Patient Care and Nursing Services › Section 10-1 - Patient care

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) All
				patient care services must:
(1) meet the
				needs of the patient, within the scope of the service offered, in accordance
				with acceptable standards of practice;
(2) be under the direction of a qualified
				person or persons; and
(3) require
				that:
(A) patient care services rendered are:
(i) reviewed and analyzed at regular meetings
				of patient care personnel; and
(ii)
				used as a basis for evaluating the quality of services provided;
				and
(B) personnel with
				appropriate training are available at all times to handle possible emergencies
				involving patients of the clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 10 - Patient Care and Nursing Services › Section 10-2 - Nursing services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
If the clinic employs licensed nurses, the clinic must ensure
				  the following:
(1) Registered nurses
				and licensed practical nurses are currently licensed in Indiana.
(2) Nursing personnel meet annual inservice
				requirements as established by clinic and federal and state
				requirements.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 11 - Infection Control Program › Section 11-1 - Infection control administration

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				clinic must do the following:
(1) Provide a
				safe and healthful environment that minimizes infection exposure and risk to
				the following:
(A) Patients.
(B) Health care workers.
(C) Persons who accompany patients.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 11 - Infection Control Program › Section 11-2 - Sterilization

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a)
				Sterilization of equipment and supplies must be provided, within the scope of
				the service offered, in accordance with acceptable standards of practice or
				manufacturer's recommendations and applicable state laws and rules (to include
				410 IAC 1-4, Universal Precautions). Sterilization services must be directed by
				a qualified person or persons and must provide for the following:
(1) Biological indicators must be used to
				check sterilization processes at least monthly. Chemical sterilizing indicators
				must be used to check the sterilizing process of individual packs.
(2) Written policies and procedures must be
				available and followed by personnel responsible for sterilizing equipment and
				supplies, including, but not limited to, the following:
(A) Minimum time and temperature for
				processing various size bundles and packs.
(B) Instructions for:
(i) loading;
(ii) operating;
(iii) cleaning; and
(iv) maintaining;
sterilizers.
(C) Instructions for:
(i) cleaning;
(ii) packaging;
(iii) storing;
(iv) labeling; and
(v) dispensing of;
sterile supplies.
(D) The procedure for maintaining and
				recording the particular sterilizing cycle.
(E) Sterilization of heat labile reusable
				equipment.
(3) Records
				of results must be maintained and evaluated periodically to include, but not be
				limited to, the following:
(A) Records of
				recording thermometers or a daily record of the sterilizing cycle:
(i) date;
(ii) time;
(iii) temperature;
(iv) pressure; and
(v) contents; for each sterilizer
				load.
(B) Results of
				biological indicators used in testing the sterilizing processes.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 11 - Infection Control Program › Section 11-3 - Laundry

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 3.
The clinic, whether it operates its own laundry or uses
				  outside laundry service, must ensure that the laundry process complies with a
				  recognized laundry standard as follows:
(1) Clean linen must be separated from soiled
				linen at all times.
(2)
				Contaminated linens must be clearly identified and bagged.
(3) Central clean linen storage space must be
				provided as follows:
(A) If commercial
				laundry services are utilized:
(i) a soiled
				linen collection area must be provided; and
(ii) a hand washing facility is required in
				each area where unbagged soiled linen is handled.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 12 - Emergency Care › Section 12-1 - Emergency care

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				clinic must have a readily accessible written protocol for the following:
(1) Managing medical emergencies that occur
				within the clinic. The protocol must ensure physician coverage and provide for
				a timely response for emergencies.
(2) The transfer of patients requiring
				further emergency care to a hospital.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 13 - Anesthesia and Surgical Services › Section 13-1 - Anesthesia services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2; IC 25
Sec. 1.
(a) The
				clinic must provide adequate anesthesia services to meet the needs of the
				patient, within the scope of the services offered, in accordance with
				acceptable standards of practice, under the direction of a licensed physician
				with specialized training or experience in the administration of
				anesthetics.
(b) Anesthesia
				services must be provided in compliance with IC 25 and rules adopted under that
				title.
(c) Anesthesia services in a
				clinic are limited to the following:
(1)
				Minimal sedation.
(2) Moderate
				sedation.
The clinic may not use deep sedation or general
				  anesthesia.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 13 - Anesthesia and Surgical Services › Section 13-2 - Surgical abortion services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a) Surgical
				abortion services must be provided in accordance with acceptable standards of
				practice and safety.
(b) Surgical
				abortions shall be performed by a physician.
(c) A physician must:
(1) either be:
(A) present in the clinic; or
(B) immediately available to the staff by
				telecommunications;
when there is a patient in the clinic; and
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 13 - Anesthesia and Surgical Services › Section 13-3 - Equipment

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 3.
(a) There
				must be sufficient patient care equipment to assure the safe, effective, and
				timely provision of the available services to patients.
(b) The following equipment and supplies must
				be available to the procedure and recovery areas:
(1) Emergency call system.
(2) Oxygen.
(3) Resuscitation equipment.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 14 - Dietary Services › Section 14-1 - Dietary services

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) If
				nourishment and other dietary needs of the patients are provided in the clinic,
				the clinic must comply with 410 IAC 7-24.
(b) If nourishments are to be prepared, a
				nourishment area with a hand washing lavatory and refrigeration must be
				provided.
(c) If prepackaged
				single-service nourishments are provided, refrigeration storage of nourishments
				and other food products must be separate from refrigeration storage for
				pharmaceuticals.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 15 - Laboratory Services › Section 15-1 - Laboratory services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) The
				clinic must provide, or make available, those pathology and medical laboratory
				services and consultations necessary to meet the needs of patients as
				determined by the medical staff.
(b) The laboratory performs tests, examines
				specimens, and reports the evaluation only upon the written request of
				individuals authorized by law.
(c)
				The clinic must assure that all laboratory services provided to its patients
				are performed in a facility possessing a valid certificate, in accordance with
				42 CFR 493 (excluding Subparts F, R, Q, and T) authorizing the performance of
				testing in the specialty or subspecialty of service for level of complexity in
				which the test is categorized.
(d)
				Laboratory supervisory and testing personnel qualifications must be:
(1) consistent with the work assignments;
				and
(2) in compliance with 42 CFR
				493.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 16 - Pharmaceutical Services › Section 16-1 - Pharmaceutical services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
The clinic must provide drugs and biologicals in a safe and
				  effective manner in accordance with accepted professional practice. The clinic
				  must have the following:
(1) A:
(A) designated professional person with
				prescriptive authority; or
(B)
				pharmacist; who is responsible for the control of drug stocks in the
				clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 17 - Physical Plant; Maintenance; Equipment; Environment; Safety › Section 17-1 - Physical plant

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2; IC 22
Sec. 1.
(a) The
				clinic must be constructed, arranged, and maintained to ensure the safety of
				the patient and to provide facilities for services authorized under the clinic
				license as follows:
(1) The plant operations
				and maintenance service, equipment maintenance, and environmental services must
				be as follows:
(A) Staffed to meet the scope
				of the services provided.
(B) Under
				the direction of a person or persons qualified by education, training, or
				experience according to clinic policy approved by the governing body.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 17 - Physical Plant; Maintenance; Equipment; Environment; Safety › Section 17-2 - Specifications of physical plant

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 2.
(a) Building
				entrances used to reach the clinic shall be as follows:
(1) At grade level.
(2) Clearly marked.
(3) Located so that patients need not go
				through other activity areas.
When the abortion clinic is part of another facility,
				  separation of and access to the clinic shall be maintained. Lobbies of
				  multioccupancy buildings may be shared. The design of the clinic shall preclude
				  unrelated traffic from the clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 17 - Physical Plant; Maintenance; Equipment; Environment; Safety › Section 17-3 - Maintenance of physical plant

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 3.
The condition of the physical plant and the overall clinic
				  environment must be developed and maintained in such a manner that the safety
				  and well-being of patients is assured as follows:
(1) No condition in the clinic or on the
				grounds may be maintained that may be conducive to the harboring or breeding
				of:
(A) insects;
(B) rodents; or
(C) other vermin.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 17 - Physical Plant; Maintenance; Equipment; Environment; Safety › Section 17-4 - Maintenance of equipment

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 4.
All patient care equipment must be in good working order and
				  regularly serviced and maintained as follows:
(1) All patient care equipment must be on a
				documented maintenance schedule of appropriate frequency in accordance with one
				(1) of the following:
(A) Acceptable
				standards of practice.
(B) The
				manufacturer's recommended maintenance schedule.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 17 - Physical Plant; Maintenance; Equipment; Environment; Safety › Section 17-5 - Environment

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 5.
The building or buildings, including fixtures, walls, floors,
				  ceiling, and furnishings throughout, must be kept clean and orderly in
				  accordance with current standards of practice, including the following:
(1) Environmental services must be provided
				in such a way as to guard against transmission of disease to patients, health
				care workers, the public, and visitors by using the current principles of the
				following:
(A) Asepsis.
(B) Cross-contamination prevention.
(C) Safe practice.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 17 - Physical Plant; Maintenance; Equipment; Environment; Safety › Section 17-6 - Safety

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 6.
(a) A safety
				management program must include, but not be limited to, the following:
(1) A review of safety functions.
(2) Development, implementation, and
				monitoring of a safety management program to include, but not be limited to,
				the following:
(A) Periodic equipment
				inspections.
(B) Insect, rodent, or
				other vermin control.
(C)
				Instructions for operating and maintaining the building or building portion and
				equipment.
(D) Chemical substance
				use and storage.
(E) Surgical waste
				and similar material disposal.
(F)
				General housekeeping precautions.
(3) An ongoing clinic-wide process to
				evaluate and collect information about hazards and safety practices.
(4) A safety program that includes, but is
				not limited to, the following:
(A) Patient
				safety.
(B) Health care worker
				safety.
(C) Public and visitor
				safety.
(5) A written
				fire control plan that contains provisions for the following:
(A) Prompt reporting of fires.
(B) Extinguishing of fires.
(C) Protection of the following:
(i) Patients.
(ii) Personnel.
(iii) Guests.
(D) Evacuation.
(E) Cooperation with firefighting
				authorities.
(F) Fire
				drills.
(6) Maintenance
				of written evidence of regular inspection and approval by state or local fire
				control agencies in accordance with the following:
(A) Clinic policy.
(B) State and local regulations.
(7) Emergency and disaster
				preparedness coordinated with appropriate community, state, and federal
				agencies.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 18 - Other Services › Section 18-1 - Other services

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a) If the
				clinic provides other services not covered in specific sections of this
				article, the services must meet the needs of the patients served, within the
				scope of the service offered, and in accordance with acceptable standards of
				practice.
(b) The services must be
				as follows:
(1) Under the direction of a
				qualified person or persons.
(2)
				Staffed in accordance with written clinic policies and in compliance with the
				applicable state and federal rules.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 18.5 - Informed Consent Brochures › Section 18.5-1 - Informed consent brochures

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2; IC 16-34-2-1.5
Sec. 1.
Abortion clinics must provide informed consent brochures, as
				  described in IC 16-34-2-1.5, in English, Spanish, and German, inside the
				  abortion clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26 - ABORTION CLINICS › Rule 19 - Incorporation by Reference › Section 19-1 - Incorporation by reference

Current through July 10, 2024
Authority: IC
				  16-21-1-7; IC
				  16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 1.
(a)42 CFR
				493 (October 1, 2017) is hereby incorporated by reference as part of this
				article.
(b) Federal rules that
				have been incorporated by reference do not include any later amendments than
				those specified in the incorporated citation. T he Code of Federal Regulations
				is found at
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
.
(c) All incorporated material is available
				for public review at the department.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 1 - Applicability › Section 1-1 - Applicability

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-19-3; IC 16-21-1
Sec. 1.
This article applies to abortion clinics that provide an
				  abortion inducing drug for the purpose of inducing an abortion. An abortion
				  clinic that performs surgical abortion procedures must comply with 410 IAC
				  26.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-1 - Applicability of definitions

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-19-3; IC 16-21-1
Sec. 1.
The definitions in this rule apply throughout this article
				  except as otherwise indicated.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-2 - "Abortion" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-18-2-1; IC 16-21-1; IC 16-21-2
Sec. 2.
"Abortion" has the meaning set forth in IC
				  16-18-2-1.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-3 - "Abortion clinic" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-18-2-1.5; IC 16-18-2-163; IC 16-21-1; IC
				  16-21-2
Sec. 3.
(a)
				"Abortion clinic" means a health care provider (as defined in IC
				16-18-2-163(d)(1)) that provides abortion inducing drugs for the purpose of
				inducing an abortion.
(b) The term
				does not include the following:
(1) A hospital
				that is licensed as a hospital under IC 16-21-2.
(2) An ambulatory outpatient surgical center
				that is licensed as an ambulatory outpatient surgical center under IC
				16-21-2.
(3) A health care provider
				that provides, prescribes, administers, or dispenses an abortion inducing drug
				to fewer than five (5) patients per year for the purposes of inducing an
				abortion.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-4 - "Affiliate" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-18-2-1.5; IC 16-18-2-9.4; IC 16-21-1; IC
				  16-21-2
Sec. 4.
"Affiliate" has the meaning set forth in IC
				  16-18-2-9.4.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-5 - "ASA Class I patient" defined

Current through July 10, 2024
Authority: IC 16-19-3-4; IC 16-21-1-7
Affected: IC 16-19-3; IC 16-21-1
Sec. 5.
"ASA Class I patient" means a normal, healthy
				  patient.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-6 - "Authenticate" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 6.
"Authenticate" means the author or responsible individual has
				  reviewed the clinical content of the order and validated an entry in the record
				  by:
(1) a full signature, including
				first initial, last name, and discipline;
(2) written initials if full signature
				appears on the same page; or
(3) a
				unique identifier such as a number or computer key.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-7 - "Biologics" defined

Current through July 10, 2024
Authority: IC 16-19-3-4; IC 16-21-1-7
Affected: IC 16-19-3; IC 16-21-1
Sec. 7.
"Biologics" means a biological product, such as:
(1) a globulin;
(2) a serum;
(3) a vaccine;
(4) an antitoxin;
(5) blood; or
(6) an antigen; used in the prevention or
				treatment of disease.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-8 - "Burn" defined

Current through July 10, 2024
Authority: IC 16-19-3-4; IC 16-21-1-7
Affected: IC 16-19-3; IC 16-21-1
Sec. 8.
"Burn" means any injury or damage to the tissues of the body
				  caused by exposure to any of the following:
(1) Fire.
(2) Heat.
(3) Chemicals.
(4) Electricity.
(5) Radiation.
(6) Gases.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-9 - "Clinic" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 9.
"Clinic" means an abortion clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-10 - "Commissioner" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 10.
"Commissioner" means the state health commissioner or the
				  state health commissioner's designee.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-11 - "Department" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 11.
"Department" means the Indiana department of
				  health.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-12 - "Division" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 12.
"Division" means the division of acute care of the
				  department.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-13 - "Elopement" defined

Current through July 10, 2024
Authority: IC 16-19-3-4; IC 16-21-1-7
Affected: IC 16-19-3; IC 16-21-1
Sec. 13.
"Elopement" means any situation in which a registered or
				  admitted patient, excluding events involving adults with decision making
				  capacity, leaves the clinic without staff being aware that the patient has done
				  so.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-14 - "Governing body" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-21-1; IC 16-21-2
Sec. 14.
"Governing body" means:
(1) board of trustees;
(2) governing board;
(3) board of directors; or
(4) other body or individual responsible for
				governing an abortion clinic.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 26.5 - ABORTION CLINICS PERFORMING DRUG INDUCED ABORTIONS › Rule 2 - Definitions › Section 2-15 - "Health care provider" defined

Current through July 10, 2024
Authority: IC 16-21-1-7; IC 16-21-2-2.5
Affected: IC 16-18-2-163; IC 16-21-1; IC 16-21-2
Sec. 15.
"Health care provider" has the meaning set forth in IC
				  16-18-2-163.