Section 410IAC17-12-1. Home health agency administration and management

   (a) Organization, services furnished, administrative control, and lines of authority for the delegation of responsibility down to the patient care level shall be:

(1) clearly set forth in writing; and

(2) readily identifiable.

Administrative and supervisory responsibilities shall not be delegated to another agency or organization, and all services not furnished directly, including services provided through a branch office, shall be monitored and controlled by the parent agency.

  (b) A governing body, or designated person or persons so functioning, shall assume full legal authority and responsibility for the operation of the home health agency. The governing body shall do the following:

(1) Appoint a qualified administrator.

(2) Adopt and periodically review written bylaws or an acceptable equivalent.

(3) Oversee the management and fiscal affairs of the home health agency.

  (c) An individual need not be a home health agency employee or be present full time at the home health agency in order to qualify as its administrator. The administrator, who may also be the supervising physician or registered nurse required by subsection (d), shall do the following:

(1) Organize and direct the home health agency's ongoing functions.

(2) Maintain ongoing liaison among the governing body and the staff.

(3) Employ qualified personnel and ensure adequate staff education and evaluations.

(4) Ensure the accuracy of public information materials and activities.

(5) Implement a budgeting and accounting system.

(6) Ensure that the home health agency meets all rules and regulations for licensure.

(7) Upon request, make available to the commissioner or his or her designated agent all:

(A) reports;

(B) records;

(C) minutes;

(D) documentation;

(E) information; and

(F) files;

required to determine compliance within seventy-two (72) hours of the request or, in the event the request is made in conjunction with a survey, by the time the surveyor exits the home health agency, whichever is sooner.

(8) Ensure that a qualified person is authorized in writing to act in the administrator's absence.

  (d) A physician or a registered nurse who has two (2) years of nursing experience, with at least one (1) year of supervisory or administrative experience, shall supervise and direct nursing and other therapeutic services. The person or similarly qualified alternate shall be on the premises or capable of being reached immediately by phone, pager, or other means. In addition, the person must be able to:

(1) respond to an emergency;

(2) provide guidance to staff;

(3) answer questions; and

(4) resolve issues;

within a reasonable amount of time, given the emergency or issue that has been raised.

  (e) The administrator shall be responsible for an ongoing quality assurance program designed to do the following:

(1) Objectively and systematically monitor and evaluate the quality and appropriateness of patient care.

(2) Resolve identified problems.

(3) Improve patient care.

  (f) Personnel practices for employees shall be supported by written policies. All employees caring for patients in Indiana shall be subject to Indiana licensure, certification, or registration required to perform the respective service. Personnel records of employees who deliver home health services shall be kept current and shall include documentation of orientation to the job, including the following:

(1) Receipt of job description.

(2) Qualifications.

(3) A copy of limited criminal history under IC 16-27-2.

(4) A copy of current license, certification, or registration.

(5) Annual performance evaluations.

  (g) As follows, personnel records of the supervising nurse, appointed under subsection (d), shall:

(1) Be kept current.

(2) Include a copy of the following:

(A) Limited criminal history under IC 16-27-2.

(B) Nursing license.

(C) Annual performance evaluations.

(D) Documentation of orientation to the job.

Performance evaluations required by this subsection must be performed every nine (9) to fifteen (15) months of active employment.

  (h) Each employee who will have direct patient contact shall have a physical examination by a physician or nurse practitioner not more than one hundred eighty (180) days before the date that the employee has direct patient contact. The physical examination shall be of sufficient scope to ensure that the employee will not spread infectious or communicable diseases to patients.

  (i) The home health agency shall ensure that all employees, staff members, persons providing care on behalf of the agency, and contractors having direct patient contact are evaluated for tuberculosis and documentation as follows:

(1) 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.

(2) 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.

(3) Any person with:

(A) a documented:

(i) history of tuberculosis;

(ii) previously positive test result for tuberculosis; or

(iii) completion of treatment for tuberculosis; or

(B) newly positive results to the tuberculin skin test;

must have one (1) chest radiograph to exclude a diagnosis of tuberculosis.

(4) After baseline testing, tuberculosis screening must:

(A) be completed annually; and

(B) include, at a minimum, a tuberculin skin test using the Mantoux method or a quantiferon-TB assay unless the individual was subject to subdivision (3).

(5) Any person having a positive finding on a tuberculosis evaluation may not:

(A) work in the home health agency; or

(B) provide direct patient contact;

unless approved by a physician to work.

(6) The home health agency must maintain documentation of tuberculosis evaluations showing that any person:

(A) working for the home health agency; or

(B) having direct patient contact;

has had a negative finding on a tuberculosis examination within the previous twelve (12) months.

  (j) The information obtained from the:

(1) physical examinations required by subsection (h); and

(2) tuberculosis evaluations and clinical follow-ups required by subsection (i);

must be maintained in separate medical files and treated as confidential medical records, except as provided in subsection (k).

  (k) The following records shall be made available, on request, to the department for review:

(1) Personnel records and policies that document the home health agency's compliance with subsection (f).

(2) Records of physical examinations that document the agency's compliance with subsection (h).

(3) Records of the following:

(A) Tuberculosis evaluations.

(B) Appropriate clinical follow-up for positive findings.

(C) Any other records that document the home health agency's compliance with subsection (i).

  (l) The department shall:

(1) treat the information described in subsection (k) as confidential medical records; and

(2) use it only for the purposes for which it was obtained.

  (m) Policies and procedures shall be written and implemented for the control of communicable disease in compliance with applicable federal and state laws. (Indiana State Department of Health; 410 IAC 17-12-1; filed Mar 18, 2002, 3:40 p.m.: 25 IR 2483; filed Sep 26, 2006, 9:56 a.m.: 20061025-IR-410050260FRA; errata filed Nov 8, 2006, 1:55 p.m.: 20061122-IR-410050260ACA; readopted filed Jul 14, 2008, 2:14 p.m.: 20080806-IR-410080322RFA; readopted filed Sep 10, 2014, 2:08 p.m.: 20141008-IR-410140299RFA)