3701-84-06. Inspections and audits

(A) The director may make announced or unannounced inspections to determine and monitor compliance with section 3702.14 of the Revised Code and the applicable requirements of Chapter 3701-84 of the Administrative Code.

(B) If patient survival or complications of the HCS are outside the industry norm or outside the range of expected values, the director may conduct a review of the HCS or require the provider of the HCS to contract for an independent review of the HCS, to be performed by at least two experts that the director has approved for the situation, to determine the probable cause of the adverse outcomes and make recommendations for improvement.

(1) In determining whether to approve an expert, the director shall consider the individual's knowledge and expertise in the service area and affiliation with the provider of the HCS;

(2) The contract shall require a written report to be submitted to the director by the reviewers within one hundred and twenty days of the director's notice to the HCS of the requirement for a review;

(3) Based on the findings of the review, the director may require the HCS to implement recommendations of the experts; and

(4) The provider of the HCS shall assume all costs of the review. The costs incurred under this paragraph are not subject to or included in the maximum annual fees specified in paragraph (G) of this rule.

(C) Each provider of a HCS shall ensure the director access to its premises, records, including business and medical records, and staff to demonstrate compliance with the requirements established under section 3702.14 of the Revised Code and the applicable requirements of Chapter 3701-84 of the Administrative Code.

(D) Information obtained by the director pertaining to specific patients is confidential. Information may be released in summary, statistical, or other form which does not disclose the identity of an individual patient. Information may be shared with other state or federal agencies if such information is necessary in carrying out their official duties. An agency or person that receives such patient record information shall protect and preserve patient confidentiality.

(E) The director may conduct an inspection to investigate alleged violations of section 3702.14 of the Revised Code and Chapter 3701-84 of the Administrative Code. The director shall inform the complainant and the HCS of the results of the investigation.

(F) The HCS fee for the inspections conducted by the director pursuant to section 3702.15 of the Revised Code and paragraphs (A) and (E) of this rule shall be, subject to paragraph (G) of this rule, as follows:

(1) Inspection fee one thousand seven hundred fifty dollars;

(2) Complaint inspection six hundred fifty dollars;

(3) Follow-up inspection six hundred fifty dollars; and

(4) Desk audit or compliance review inspection fee of two hundred fifty dollars.

(G) In charging a provider of a health care service a fee under paragraph (F) of this rule the total fees charged to a provider of a health care service, for services described in section 3702.11 of the Revised Code, shall not exceed five thousand dollars annually.

(H) The director shall provide to each provider of a health care service a statement of the fee charged under paragraph (F) of this rule which itemizes and totals the costs incurred by the department.

(I) The provider of a health care service shall forward the total amount of the fee to the director payable to the "Treasurer, State of Ohio " within fifteen days after receiving a statement of the fee issued under paragraph (H) of this rule.

(J) The director shall deposit HCS fees into the quality monitoring and inspection fund created in the state treasury pursuant to division (A) of section 3702.31 of the Revised Code.

Effective: 8/1/2017
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13, 3702.31
Rule Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 5/23/98, 3/24/03, 6/1/07, 6/21/12