Effective 01 Jul 2018, see footnote

197.080. Rules, procedure — regulations and standards — review and revision of regulations — rulemaking authority. — 1. The department of health and senior services, with the advice of the state advisory council and pursuant to the provisions of this section, section 197.005, and chapter 536, shall adopt, amend, promulgate and enforce such rules, regulations and standards with respect to all hospitals or different types of hospitals to be licensed hereunder as may be designed to further the accomplishment of the purposes of this law in promoting safe and adequate treatment of individuals in hospitals in the interest of public health, safety and welfare. No rule or portion of a rule promulgated under the authority of sections 197.010 to 197.280 shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

2. The department shall review and revise regulations governing hospital licensure and enforcement to promote hospital and regulatory efficiencies. The department shall eliminate all duplicative regulations and inspections by or on behalf of state agencies and the Centers for Medicare and Medicaid Services (CMS). The hospital licensure regulations adopted under this chapter shall incorporate standards which shall include, but not be limited to, the following:

(1) Each citation or finding of a regulatory deficiency shall refer to the specific written regulation, any state associated written interpretive guidance developed by the department and any publicly available, professionally recognized standards of care that are the basis of the citation or finding;

(2) Subject to appropriations, the department shall ensure that its hospital licensure regulatory standards are consistent with and do not contradict the CMS Conditions of Participation (COP) and associated interpretive guidance. However, this shall not preclude the department from enforcing standards produced by the department which exceed the federal CMS' COP and associated interpretive guidance, so long as such standards produced by the department promote a higher degree of patient safety and do not contradict the federal CMS' COP and associated interpretive guidance;

(3) The department shall establish and publish guidelines for complaint investigation, including but not limited to:

(a) The department's process for reviewing and determining which complaints warrant an on-site investigation based on a preliminary review of available information from the complainant, other appropriate sources, and when not prohibited by CMS, the hospital. For purposes of providing hospitals with information necessary to improve processes and patient care, the number and nature of complaints filed and the recommended actions by the department and, as appropriate CMS, shall be disclosed upon request to hospitals so long as the otherwise confidential identity of the complainant or the patient for whom the complaint was filed is not disclosed;

(b) A departmental investigation of a complaint shall be focused on the specific regulatory standard and departmental written interpretive guidance and publicly available professionally recognized standard of care related to the complaint. During the course of any complaint investigation, the department shall cite any serious and immediate threat discovered that may potentially jeopardize the health and safety of patients;

(c) A hospital shall be provided with a report of all complaints made against the hospital. Such report shall include the nature of the complaint, the date of the complaint, the department conclusions regarding the complaint, the number of investigators and days of investigation resulting from each complaint;

(4) Hospitals and hospital personnel shall have the opportunity to participate in annual continuing training sessions when such training is provided to state licensure surveyors with prior approval from the department director and CMS when appropriate. Hospitals and hospital personnel shall assume all costs associated with facilitating the training sessions and use of curriculum materials, including but not limited to the location for training, food, and printing costs;

(5) Time lines for the department to provide responses to hospitals regarding the status and outcome of pending investigations and regulatory actions and questions about interpretations of regulations shall be identical to, to the extent practicable, the time lines established for the federal hospital certification and enforcement system in the CMS State Operations Manual, as amended. These time lines shall be the guide for the department to follow. Every reasonable attempt shall be made to meet the time lines. However, failure to meet the established time lines shall in no way prevent the department from performing any necessary inspections to ensure the health and safety of patients.

3. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2013, shall be invalid and void.

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(L. 1953 p. 631 § 8, A.L. 1993 S.B. 52, A.L. 1995 S.B. 3, A.L. 2013 H.B. 351, A.L. 2017 S.B. 50 merged with S.B. 501)

Effective 7-01-18