Chapter 3701-83 Licensing Provisions for Health Care Facilities

As used in this chapter:

(A) “Accreditation inspection report” means the written survey findings concerning a health care facility prepared by an entity that the director has determined as having standards and a process for assessing compliance which equal or exceed the requirements of section 3702.30 of the Revised Code and the applicable requirements of Chapter 3701-83 of the Revised Code.

(B) “Administrator” means the person responsible for the overall daily management of the health care facility.

(C) “Advanced directives” means a written document executed in accordance with section 2133.02 or section 1337.12 of the Revised Code.

(D) “Current procedural terminology” or “CPT” means the comprehensive listing of medical terms and codes published by the American medical association for the uniform designation of diagnostic and therapeutic procedures in surgery, medicine and the specialties.

(E) “Dentist” means a person licensed under Chapter 4715. of the Revised Code to practice dentistry.

(F) “Department” means the Ohio department of health.

(G) “Dialysis station” or “station” means the equipment used to provide chronic maintenance dialysis for a single patient at a given time, including equipment used for self-dialysis and isolation stations

(H) “Director” means the director of health or any official or employee of the department designated by the director of health.

(I) “Health care facility” or “HCF” means any of the following:

(1) An ambulatory surgical facility as defined in rule 3701-83-15 of the Administrative Code;

(2) A freestanding dialysis center as defined in rule 3701-83-23 of the Administrative Code;

(3) A freestanding inpatient rehabilitation facility as defined in rule 3701-83-25 of the Administrative Code;

(4) A freestanding birthing center as defined in rule 3701-83-33 of the Administrative Code;

(5) A freestanding radiation therapy center as defined in rule 3701-83-43 of the Administrative Code; and

(6) A freestanding or mobile diagnostic imaging center as defined in rule 3701-83-51 of the Administrative Code.

(J) “Hospital” means an institution required to be registered under section 3701.07 of the Revised Code.

(K) “Licensed practical nurse” or “LPN” means a person licensed under Chapter 4723. of the Revised Code to practice nursing as a licensed practical nurse.

(L) “Medical director” means the physician who is responsible for managing and directing the provision of medical services at the health care facility unless otherwise indicated in Chapter 3701-83 of the Administrative Code.

(M) “Nurse” means either a licensed practical nurse or a registered nurse.

(N) “Owner” means any person who holds a legal, or equitable, or possessory interest of any kind in a health care facility, including, without limitation, a trust, vendor, vendee, lessor, or lessee. Owner does not include a person who holds indicia of ownership primarily to protect the person’s security interest in the health care facility.

(O) “Patient” means any individual who receives services in a health care facility.

(P) “Patient representative” means either a person acting on behalf of a patient with the consent of the patient or the patient’s legal guardian.

(Q) “Personnel” means all individuals working in the health care facility.

(R) “Physician” means a person who is licensed under Chapter 4731. of the Revised Code to practice medicine and surgery, or osteopathic medicine and surgery.

(S) “Podiatrist” means a person licensed to practice podiatry under Chapter 4731. of the Revised Code.

(T) “Registered nurse” or “RN” means a person who is licensed under section 4723. of the Revised Code to practice nursing as a registered nurse.

(U) “Staff member” or “staff” means the administrator and individuals providing direct care to patients on a full-time, part-time, temporary, contract or voluntary basis. “Staff member” does not include a volunteer who provides direct care only to a member of his or her family.

(V) “Surgery” means any medical procedure performed upon the body of a living human being, regardless of the length of time the procedure takes, involving the invasion, alteration, cutting, disruption, destruction, resection, or removal of human tissue or bone by use of sharp-edged instruments, lasers, electrical cautery, cryoprobes, or any other medically accepted means for the purposes of preserving health, diagnosing or curing disease, repairing injury, correcting deformity or defects, prolonging life, relieving suffering, or for aesthetic, reconstructive, or cosmetic purposes. “Surgery” does not include the suturing of minor lacerations.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Except as provided in section 3702.301 of the Revised Code and paragraph (B) of rule 3701-83-03 of the Administrative Code, all health care facilities shall comply with rules 3701-83-02 to 3701-83-14 of the Administrative Code. In addition, all:

(1) Ambulatory surgical facilities shall comply with rules 3701-83-15 to 3701-83-22 of the Administrative Code;

(2) Freestanding dialysis centers shall comply with rules 3701-83-23 to 3701-83-24 of the Administrative Code;

(3) Freestanding inpatient rehabilitation facilities shall comply with rules 3701-83-25 to 3701-83-32 of the Administrative Code;

(4) Freestanding birthing centers shall comply with rules 3701-83-33 to 3701-83-42 of the Administrative Code;

(5) Freestanding radiation therapy centers shall comply with rules 3701-83-43 to 3701-83-50 of the Administrative Code; and

(6) Freestanding or mobile diagnostic imaging centers shall comply with rules 3701-83-51 to 3701-83-55 of the Administrative Code.

(B) Freestanding birthing centers exempted from licensure under section 3702.301 of the Revised Code and paragraph (B) of rule 3701-83-03 of the Administrative Code shall comply with rules 3701-83-56 to 3701-83-59 of the Administrative Code.

Effective: 06/01/2007

R.C. 119.032 review dates: 02/27/2007 and 06/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.12

Rule Amplifies: 3702.30, 3702.301

Prior Effective Dates: 1/13/1996

(A) Except as provided in section 3702.301 of the Revised Code and paragraph (B) of this rule, no person or agency of state or local government shall operate an HCF without a license issued by the director under section 3702.30 of the Revised Code or operate an HCF when the license has been suspended or revoked.

(B) Except as provided in division (C) of section 3702.301 of the Revised Code and paragraph (C) of rule 3701-83-59 of the Administrative Code, a freestanding birthing center is not required to obtain a license under section 3702.30 of the Revised Code if all of the following are the case:

(1) A religious denomination, sect, or group owns and operates the center;

(2) Requiring that the center be licensed significantly abridges or infringes on the religious practices or beliefs of that religious denomination, sect, or group;

(3) The center provides care only during low-risk pregnancy, delivery, and the immediate postpartum period exclusively to women who are members of that religious denomination, sect, or group;

(4) The center monitors and evaluates the care provided to its patients in accordance with at least the minimum patient safety monitoring and evaluation requirements of rule 3701-83-57 of the Administrative Code; and

(5) The center meets the quality assessment and improvement standards established in rule 3701-83-58 of the Administrative Code.

(C) No person or agency of state or local government shall:

(1) Interfere with an inspection or investigation of an HCF by the director; or

(2) Materially misrepresent any information provided to the director pursuant to section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code.

(D) Each HCF shall comply with all applicable state and federal laws and regulations.

(E) Nothing in this chapter shall be construed to alter or affect the law with respect to the corporate practice of medicine and surgery or osteopathic medicine and surgery or dentistry.

(F) The HCF shall have an identifiable governing body which develops and implements policies and procedures and a mission statement for the orderly development and management of the HCF.

(G) Each HCF shall either maintain documentation of appropriate liability insurance coverage of the staff and consulting specialists or inform patients that the staff member or consulting specialist does not carry malpractice insurance.

(H) No HCF shall permit any person to smoke inside the HCF. The HCF shall post a notice in a conspicuous place within the HCF stating that smoking is prohibited inside the HCF.

(I) Nothing in this chapter shall be construed as authorizing individuals to provide services outside their licensed scope of practice.

(J) The owner, administrator, and medical director shall be competent to perform the respective responsibilities.

Effective: 06/01/2007

R.C. 119.032 review dates: 02/27/2007 and 06/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30, 3702.301

Rule Amplifies: 3702.12, 3702.13, 3702.30, 3702.301

Prior Effective Dates: 1/13/1996, 6/27/96, 9/5/02, 6/1/06

(A) A person or agency of state or local government seeking a license to operate an HCF shall submit to the director an application, on a form prescribed and provided by the director, which shall include the following items:

(1) A statement of ownership containing the following information:

(a) The name, address, and telephone number of the HCF.

(i) If the owner is an individual, the owner’s name, address, telephone number, business address, and business telephone number.

(ii) If the owner is an association, corporation, limited liability company, or partnership, the address, and telephone number of the entity and the name of every person who has an ownership interest of five percent or more in the entity. The corporate name, if any, and the names, titles, addresses and telephone numbers of its officers and statutory agent.

(iii) If the applicant is an agency of state or local government, the name, address and telephone number of the individual authorized to enter into agreements on behalf of the agency of state or local government.

(b) The name of the administrator and the name and physician license number or dentist license number of the medical director of the HCF;

(c) The name and address of any of the following facilities which either the owner, administrator or medical director has been affiliated through ownership or employment in the five years prior to the date of the application:

(i) A nursing home, residential care facility, or home for the aging as defined in section 3721.01 of the Revised Code;

(ii) A habilitation center as defined in section 5111.041 of the Revised Code;

(iii) A residential facility for the mentally ill licensed by the department of mental health under section 5119.22 of the Revised Code;

(iv) A facility licensed to provide methadone treatment under section 3793.11 of the Revised Code;

(v) A residential facility licensed under section 5123.19 of the Revised Code or otherwise regulated by the department of mental retardation and developmental disabilities;

(vi) A community alternative home as defined by section 3724.01 of the Revised Code;

(vii) A terminal care facility for the homeless that has entered into an agreement with a hospice care program under section 3712.07 of the Revised Code;

(viii) An adult care facility as defined by section 3722.01 of the Revised Code;

(ix) A health insuring corporation as defined by section 1751.01 of the Revised Code;

(x) A hospital; or

(xi) An entity certified by the United States centers for medicare and medicaid services for purposes of reimbursement under Part B of the medicare program, Part B of Title XVIII of the “Social Security Act,” 49 Stat. 620 (1935), 42 U.S.C.A. 301, As amended; or certified for the purposes of reimbursement by medicaid, a state plan approved under Title XIX of the Social Security Act,” 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended.

(d) Information about any criminal conviction, civil judgment or administrative adjudication of the owner, administrator or medical director for an offense related to the provision of care or bearing a direct or substantial relationship to the job responsibilities he or she is to carry out.

(2) If applicable, a copy of the fire inspection report required under paragraph (C) of rule 3701-83-06 of the Administrative Code and if applicable, the certificate of use and occupancy required under rule 3701-83-10 of the Administrative Code;

(3) The type of HCF license for which the applicant is applying; in addition:

(a) An ASF shall specify the number of operating rooms;

(b) A freestanding dialysis center shall specify the number of dialysis stations, including the number of hemodialysis stations and peritoneal stations;

(c) A freestanding inpatient rehabilitation facility shall specify the number of patient care beds;

(d) A freestanding birthing center shall specify the number of birth rooms;

(e) A freestanding or mobile diagnostic imaging center shall specify whether the radiopharmaceuticals being proposed for use are for use as delineated in rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37 or 3701:1-58-53 of the Administrative Code and the number and type of radiation-generating or detecting equipment;

(f) A freestanding radiation therapy center shall specify the number and type of radiation-generating or detecting equipment being proposed for use and whether radiopharmaceuticals or sealed sources being proposed for use are for use as delineated in rules 3701:1-58-43 or 3701:1-58-55 of the Administrative Code.

(4) A complete copy of the HCF’s current accreditation inspection report, if applicable.

(B) A person or agency of state or local government seeking renewal of an HCF license shall submit to the director an application for renewal each year during the month specified on the HCF’s license. A person or agency of state or local government seeking renewal of an HCF license, or an amended license under paragraph (F) of this rule, shall submit to the director an application on a form prescribed and provided by the director, and shall include the following items:

(1) The name, address, and telephone number of the facility;

(2) The type of facility for which the applicant is seeking license renewal;

(3) Any changes or updates to the information required by paragraph (A) of this rule, including a copy of the most recent accreditation inspection report and findings, if applicable, unless the department has been previously notified;

(4) Copies of all inspections, agreements, or approvals required by Chapter 3701-83 of the Administrative Code, that have been conducted since submittal of the HCF’s previous application;

(5) Any other information the director may require regarding the owner’s ability to operate the facility.

(C) An application for an HCF license, license renewal or amended license shall include the following:

(1) Certification that to the best of the applicant’s knowledge, the information in the application and any accompanying material is true and accurate;

(2) Certification by the medical director and the administrator that to the best of their knowledge, the information in the application submitted pursuant to paragraph (A)(1)(c) of this rule is true and accurate;

(3) Certification that the applicant, if not the owner, is the authorized representative of the owner, and

(4) A nonrefundable application fee of three hundred dollars for an HCF license or license renewal or a nonrefundable fee of one hundred and fifty dollars for an amended HCF license payable to the “Treasurer, State of Ohio”.

(D) The director at any time may request additional information he or she determines to be necessary to assess compliance with the applicable criteria, standards, and requirements established by section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code. The applicant shall submit any additional information requested by the director within sixty days of the director’s request.

(E) The HCF shall notify the director in writing no later than thirty days of:

(1) Any changes in the information contained in the statement of ownership made pursuant to paragraph (A) of this rule; and

(2) Any change in the HCF’s accreditation status.

(F) The HCF shall apply for an amended license if:

(1) In the case of an ASF, there is any increase in the number of operating rooms;

(2) In the case of a freestanding dialysis center, there is any increase in the number of dialysis stations;

(3) In the case of a freestanding inpatient rehabilitation facility, there is any increase in the number of patient care beds;

(4) In the case of a freestanding birthing center, there is any increase in the number of birthing rooms;

(5) In the case of a freestanding or mobile diagnostic imaging center, there is any increase in the number or change in the type of radiation-generating or detecting equipment or any change in the radiopharmaceuticals being used pursuant to rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, or 3701:1-58-53 of the Administrative Code; and

(6) In the case of a freestanding radiation therapy center, there is any increase in the number or change in the type of radiation-generating or detecting equipment being used or any change in the radiopharmaceuticals or sealed sources being used pursuant to rules 3701:1-58-43 or 3701:1-58-55 of the Administrative Code.

(G) The HCF shall not use any additional room, station, bed or equipment until an amended HCF license has been issued, or the HCF has received other verifiable approval by the department.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/201

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30, 3702.31

Rule Amplifies: 3702.12, 3702.13, 3702.30, 3702.31

Prior Effective Dates: 1/13/1996, 6/27/96, 5/23/98, 7/26/2001, 9/5/02

(A) The director shall issue or renew a license to an HCF that submits an application for license in accordance with rule 3701-83-04 of the Administrative Code and that demonstrates to the director it meets the requirements of section 3702.30 of the Revised Code and the requirements of Chapter 3701-83 of the Administrative Code.

Nothing herein shall exempt any HCF from the data reporting requirements of Chapter 3701-83 of the Administrative Code, the fee requirements of paragraph (C) of rule 3701-83-04 of the Administrative Code, and any other applicable state or federal law or regulation.

(1) Except as provided in paragraph (A)(2), or (A)(3) of this rule, HCFs that have submitted an acceptable accreditation inspection report at the time of licensure renewal will not be required to otherwise demonstrate compliance with Chapter 3701-83 of the Administrative Code.

(2) The director may renew an ASF license without conducting an onsite inspection when:

(a) The ASF has submitted an approval letter that indicates the ASF is duly accredited and deemed in compliance with federal medicare program requirements at the time of licensure renewal. The ASF shall provide the accreditation inspection report if requested by the director. The director may conduct a validation inspection prior to issuing the renewal license. Such accreditation may be from the joint commission on accreditation of healthcare organizations (JCAHO), the accreditation association for ambulatory health care (AAAHC), the American osteopathic association (AOA), the American association for the accreditation of ambulatory surgical facilities (AAAASF), or any other national accrediting body approved for deeming authority by the Centers for Medicare and Medicaid Services, thereby indicating that the accrediting body’s standards meet or exceed the applicable medicare program requirements for health care facilities as set forth in this chapter; or

(b) The ASF has been determined to be in compliance with the medicare program conditions of coverage for ambulatory surgical centers by virtue of a department conducted medicare certification or recertification survey within ninety days prior to the licensure renewal date.

(3) The director may renew a birth center license without conducting an onsite survey when that birth center has submitted an approval letter that indicates the birth center is duly accredited by the commission for the accreditation of birth centers at the time of license renewal. The birth center shall provide the accreditation inspection report if requested by the director. The director may conduct a validation survey prior to issuing the renewal license.

(4) The director shall only issue one license of the same type at a given location for the following types of health care facilities:

(a) Ambulatory surgical facility;

(b) Freestanding inpatient rehabilitation facility;

(c) Freestanding birthing center; or

(d) Freestanding dialysis center.

(B) Any license issued to an HCF:

(1) Shall contain the name and address of the facility for which it was issued, the effective date of the license, and the month the HCF must apply for renewal of the license. In addition:

(a) The license for an ambulatory surgical facility shall specify the maximum number of operating rooms;

(b) The license for a freestanding dialysis center shall specify the maximum number of dialysis stations;

(c) The license for a freestanding inpatient rehabilitation facility shall specify the maximum number of patient care beds;

(d) The license for a freestanding birthing center shall specify the number of birth rooms;

(e) The license for a freestanding or mobile diagnostic imaging center shall specify the number and type of equipment.

(2) Is valid unless revoked or suspended pursuant to Chapter 119. of the Revised Code, or voided at the request of the owner, or the HCF fails to timely apply for a renewal in accordance with paragraph (B) of rule 3701-83-04 of the Administrative Code; and

(3) Is valid only for the facility specified on the license at the listed address.

(C) The director shall in accordance with Chapter 119. of the Revised Code, deny an application for a license or an application for amendment or renewal of a license if:

(1) The HCF fails to make application for a license in accordance with rule 3701-83-04 of the Administrative Code;

(2) Fails to demonstrate to the director that the HCF meets or continues to meet the requirements of section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code;

(3) The director determines that the owner, administrator, or medical director is not competent to operate an HCF based on review of information pertaining to paragraphs (A)(1)(c) and (A)(1)(d) of rule 3701-83-04 of the Administrative Code.

(D) The HCF shall notify the director within thirty days of termination of an accreditation.

(E) In addition to any other provision of Chapter 3701-83 of the Administrative Code, if the director granted a license based on the HCF demonstrating compliance through submittal of an accreditation inspection report and one of the events listed in this paragraph occurs, the director may inspect or request additional information from the HCF to determine whether the HCF meets the requirements of section 3702.30 of the Revised Code and the applicable requirements of Chapter 3701-83 of the Administrative Code.

(1) The HCF’s accreditation is terminated;

(2) The HCF’s accreditation expires and is not renewed; or

(3) The director no longer recognizes the accrediting entity as having standards and processes equal to or exceeding those established in section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 5/23/98, 9/5/2002

(A) If the director determines that an HCF is operating without a license in violation of division (E)(1) of section 3702.30 of the Revised Code, the director shall do one or more of the following:

(1) Notify the HCF that it is operating without a license and issue a written order that the HCF apply for a license. The order shall specify the time frame for filing a complete application in accordance with rule 3701-83-04 of the Administrative Code that shall not exceed thirty days after the date of the order;

(2) Issue a written order that the HCF cease its operations. The department shall deliver the written order issued under section 3702.32 of the Revised Code to the HCF. The order shall be effective no later than fifteen days after the facility receives the order, and shall stay in effect until such time as specified by the director or until a license is issued;

(3) Issue a written order that prohibits the HCF from performing certain types of services. The department shall deliver the written order issued under section 3702.32 of the Revised Code to the HCF. The order shall be effective on the date specified in the order and shall stay in effect until such time as specified by the director or until a license is issued;

(4) Impose a civil penalty as provided under paragraph (A) of rule 3701-83-05.2 of the Administrative Code. The civil penalty shall not be less than one thousand dollars and not more than two hundred and fifty thousand dollars;

(5) Impose an additional civil penalty as provided under paragraph (D) of rule 3701-83-05.2 of the Administrative Code. The civil penalty shall not be less than one thousand dollars and not more than ten thousand dollars for each day that the HCF continues to operate without a license in violation of an order issued under paragraph (A) of this rule.

(B) The director may file a petition in the court of common pleas of the county in which a HCF is located for an injunction enjoining the facility from operating if the HCF is subject to an order issued:

(1) Under paragraph (A)(1) of this rule but the HCF continues to operate in violation of such order after the time frame specified for filing an application; or

(2) Under paragraph (A)(2) of this rule but the HCF continues to operate or provide services in violation of such order.

(C) If the director determines that the HCF is not complying with any provision of section 3702.30 of the Revised Code, other than a violation under division (E)(1) or (E)(2) of that section, any provision of Chapter 3701-83 of the Administrative Code, or any other rule adopted by the director under section 3702.30 of the Revised Code, the director may do any or all of the following in accordance with Chapter 119. of the Revised Code:

(1) Provide an opportunity to correct the violation within a specified period of time;

(2) Revoke, suspend, or refuse to renew the license;

(3) Prior to or during the pendency of an administrative hearing under Chapter 119. of the Revised Code, issue an order that prohibits the HCF from performing certain types of services. The order shall be effective on the date specified in the order;

(4) Impose a civil penalty as provided under paragraph (A) of rule 3701-83-05.2 of the Administrative Code. The civil penalty shall not be less than one thousand dollars and not more than two hundred and fifty thousand dollars;

(5) Impose an additional civil penalty as provided under paragraph (E) of rule 3701-83-05.2 of the Administrative Code. The civil penalty shall not be less than five hundred dollars and not more than ten thousand dollars for each day that the HCF fails to correct the violation.

(D) In determining which of the actions to take under paragraph (C) of this rule, the director may consider, but is not limited to, any or all of the following factors:

(1) The danger of serious physical or life threatening harm to one or more patients of the HCF;

(2) The nature, duration, gravity, and extent of the violation;

(3) Whether the violation directly relates to patient care;

(4) The number, if any, of patients directly affected by the violation;

(5) The extent of any actual or potential harm to patients;

(6) The actions taken by the HCF to correct the violation; and

(7) The compliance history of the HCF.

(E) The director may file a petition in the court of common pleas of the county in which the facility is located for an injunction enjoining:

(1) A HCF that is operating without a license from performing certain types of services if the HCF is subject to an order issued under paragraph (A)(3) of this rule but continues to perform the types of services prohibited by the order; or

(2) A licensed HCF from performing certain types of services if the HCF is subject to an order issued under paragraph (C)(3) of this rule but continues to perform the types of services prohibited by the order.

(F) If, after reporting under division (E)(2) of section 3702.30 of the Revised Code that a physician failed to obtain informed consent under any provision of the Revised Code, the department finds that the physician has continued to engage in a pattern of violating the same informed consent provision at the HCF and that the HCF has failed to take reasonable steps to ensure that the physician does not continue the same violation at the HCF, the department may, after providing the HCF an opportunity for a hearing pursuant to Chapter 119. of the Revised Code, impose a civil penalty on the HCF. The penalty shall be not less than one thousand dollars and not more than fifty thousand dollars. For the purpose of this paragraph, “pattern” means a violation of the same provision of the Revised Code that reasonably could have been prevented by a facility’s corrective action and was determined by the department to have occurred at least twice after the department made its report as provided in division (E)(2) of section 3702.30 of the Revised Code.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30, 3702.32

Rule Amplifies: 3702.12, 3702.13, 3702.30, 3702.32

(A) Except as provided under paragraph (B) of this rule, civil penalties imposed under paragraph (A)(4) or paragraph (C)(4) of rule 3701-83-05.1 of the Administrative Code for a violation of section 3702.30 of the Revised Code, Chapter 3701-83 of the Administrative Code, or any other rule adopted by the director under section 3702.30 of the Revised Code shall be imposed as follows:

(1) If no harm has occurred to any patient, one thousand to fifty thousand dollars;

(2) If harm has occurred to one or more patients, fifty-one thousand to one hundred thousand dollars;

(3) If there has been permanent injury to one or more patients, one hundred and one thousand to one hundred and fifty thousand dollars; and

(4) If death has occurred to one or more patients, one hundred and fifty-one thousand to two hundred and fifty thousand dollars.

(B) Except as otherwise required by law, if there has been a history of uncorrected violations of section 3702.30 of the Revised Code, Chapter 3701-83 of the Administrative Code, or any other rule adopted under section 3702.30 of the Revised Code that caused no actual harm to a patient, but had the potential to cause more than minimal harm, a fine of up to two hundred and fifty thousand dollars may be imposed.

(C) In determining the level of civil monetary penalties imposed under this paragraph, the total amount of fines for violations discovered during one inspection shall not exceed two hundred and fifty thousand dollars.

(D) Additional civil penalties imposed under paragraph (A)(5) of rule 3701-83-05.1 of the Administrative Code shall be imposed on a per day basis of one thousand to ten thousand dollars for each day that the HCF continues to operate without a license in violation of a written order issued under paragraph (A) of rule 3701-83-05.1.

(E) Additional civil penalties imposed under paragraph (C)(5) of rule 3701-83-05.1 of the Administrative Code shall be imposed on a per day basis of five hundred to ten thousand dollars for each day the HCF fails to correct the violation.

(F) Civil penalties imposed under paragraph (F) of rule 3701-83-05.1 of the Administrative Code shall be imposed as follows:

(1) If a physician failed to obtain informed consent from less than ten patients, but no patients were harmed, one thousand to twenty-five thousand dollars;

(2) If a physician failed to obtain informed consent from ten or more patients, but no patients were harmed, twenty-six thousand to fifty thousand dollars; and

(3) If harm occurs to one or more patients as a result of a physician’s failure to obtain informed consent, thirty thousand to fifty thousand dollars per patient.

(G) In determining the amount of civil penalties imposed under paragraphs (A) and (F) of this rule, the director may consider, but is not limited to, any or all of the following factors:

(1) The compliance history of the HCF;

(2) The number of patients directly affected;

(3) The impact of the noncompliance on the patient or patients;

(4) Whether the violation is repetitive in nature or is similar to previous violations;

(5) The length or duration of the violation; and

(6) The time period between the current violation and any similar previous violation.

(H) Except for civil penalties imposed upon an HCF under paragraph (A)(4) of rule 3701-83-05.1 of the Administrative Code, the HCF may appeal the imposition of civil penalties imposed under this rule in accordance with Chapter 119. of the Revised Code. If the HCF obtains a license or comes into compliance and waives the right to a hearing provided under Chapter 119. of the Revised Code, the civil penalty may be reduced up to fifty percent but shall not be less than one thousand dollars.

(I) If the department issues more than one order, any administrative hearing resulting from such orders may be consolidated into one hearing. Consolidation of the hearings does not affect any effective dates prescribed in the orders.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30, 3702.32

Rule Amplifies: 3702.12, 3702.13, 3702.30, 3702.32

(A) The director may make announced or unannounced inspections as the director considers necessary to determine compliance with section 3702.30 of the Revised Code and the applicable requirements of Chapter 3701-83 of the Administrative Code. The director may notify ASFs, freestanding dialysis centers, freestanding inpatient rehabilitation facilities, and freestanding birth centers prior to conducting announced inspections for initial and renewal licensing. Such prior notification shall be no earlier than thirty days and no later than two weeks prior to start date of the survey.

(B) Immediately upon request, each HCF shall provide the director access to its premises, facility and patient records, including medical records, and staff to enable the director to determine compliance with section 3702.30 of the Revised Code and the applicable requirements of Chapter 3701-83 of the Administrative Code.

(C) Prior to the issuance of an initial license the HCF shall obtain documentation from the state fire marshal or fire prevention officer of a municipal, township, or other legally constituted fire department approved by the fire marshal that the HCF is in compliance with the state fire code. In the case of an HCF regulated by the state fire code, following the initial license the HCF shall obtain documentation, every twelve months and at any other time requested by the director, that the HCF continues to be in compliance with the state fire 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.

(E) The director may conduct an inspection to investigate alleged violations of section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code. The director shall inform the complainant and the HCF of the results of the inspection.

(F) For purposes of this paragraph “follow-up inspection” means an inspection conducted by the department to determine whether an HCF has corrected a violation or violations cited on a previous inspection and to verify whether an HCF is in compliance with the applicable criteria, standards, and requirements established by section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code. “Validation inspection” means an inspection of an HCF that submitted an acceptable accreditation inspection report or an approval letter. The HCF fee for inspections conducted by the director pursuant to section 3702.30 of the Revised Code and paragraphs (A) and (E) of this rule shall be as follows:

(1) Inspection fee of $1,750.00;

(2) Complaint inspection fee of $875.00;

(3) Follow-up inspection fee of $875.00; and

(4) Validation inspection fee of $1,750.00.

(G) Notwithstanding the requirements of paragraph (F) of this rule, the fee for an inspection of a free-standing radiation therapy center or a free-standing diagnostic or mobile imaging center shall be determined as follows. To the extent practicable, inspections done to determine compliance with Chapter 3748. of the Revised Code shall be done concurrently with inspections to determine compliance with Chapter 3701-83 of the Administrative Code.

(1) Inspection fee of $950.00;

(2) Follow-up inspection fee of $475.00;

(3) Complaint fee of $475.00; and

(4) Desk audit or compliance review inspection fee of $250.00.

(H) The director shall provide to each HCF inspected pursuant to section 3702.30 of the Revised Code and paragraph (A) or (E) of the rule a written statement of the fee established in paragraph (F) or (G) of this rule. The statement shall itemize the total costs incurred.

(I) Each HCF within fifteen days after receiving a statement of the fee issued under paragraph (F) or (G) of this rule shall forward the total amount of the fee to the director payable to the “Treasurer, State of Ohio.”

(J) The director shall deposit HCF 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: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.15, 3702.30

Rule Amplifies: 3702.12 , 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 6/27/96, 5/23/98, 7/26/2001, 9/5/02

(A) The HCF shall develop and follow comprehensive and effective patient care policies that include the following requirements:

(1) Each patient shall be treated with consideration, respect, and full recognition of dignity and individuality, including privacy in treatment and personal care needs;

(2) Each patient shall be allowed to refuse or withdraw consent for treatment;

(3) Each patient shall have access to his or her medical record, unless access is specifically restricted by the attending physician for medical reasons;

(4) Each patient’s medical and financial records shall be kept in confidence; and

(5) Each patient shall receive, if requested, a detailed explanation of facility charges including an itemized bill for services received.

(B) The HCF shall inform each patient of the following:

(1) The HCF’s policy on advance directives; and

(2) The name of the attending physician or individual supervising the patient’s care and the manner in which that individual may be contacted.

(C) The HCF shall implement a patient satisfaction survey program.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Each HCF shall utilize personnel that have appropriate training and qualifications for the services that they provide. Any staff member who functions in a professional capacity shall meet the standards applicable to that profession, including but not limited to possessing a current Ohio license, registration, or certification, if required by law, and working within his or her scope of practice. Copies of current Ohio licenses, registrations and certifications shall be kept in the employee’s personnel files or the provider of the HCF shall have an established system to verify and document the possession of current Ohio licenses, registrations or other certifications required by law. Nurse licenses shall be copied in accordance with paragraph (E) of rule 4723-7-09 of the Administrative Code.

(B) The HCF shall develop and follow a tuberculosis control plan that is based on the provider’s assessment of the facility. The control and assessment shall be consistent with the centers for disease control and prevention (CDC) “Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health Care Settings, 2005,” MMWR 2005, Volume 54, No. RR-17. The HCF shall retain documentation evidencing compliance with this paragraph and shall furnish such documentation to the director upon request.

(C) The HCF shall not knowingly permit a staff member to provide services if the staff member:

(1) Has a communicable disease capable of being transmitted during the performance of his or her duties; or

(2) Is under the influence of drugs or alcohol.

(D) The HCF shall provide each staff member with a written job description delineating his or her responsibilities.

(E) Each HCF shall provide an ongoing training program for its staff. The program shall provide both orientation and continuing training to all staff members. The orientation shall be appropriate to the tasks that each staff member will be expected to perform. Continuing training shall be designed to assure appropriate skill levels are maintained and that staff are informed of changes in techniques, philosophies, goals, and similar matters. The continuing training may include attending and participating in professional meetings and seminars.

(F) All staff shall have appropriate orientation and training regarding the facility’s equipment, safety guidelines, practices, and policies.

(G) Each HCF shall evaluate the performance of each staff member at least every twelve months.

(H) Each HCF shall retain staffing schedules, time-worked schedules, on-call schedules, and payroll records for at least two years.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) The HCF shall assure all staff members provide services in accordance with:

(1) Applicable current and accepted standards of practice and the clinical capabilities of the HCF; and

(2) Applicable state and federal laws and regulations.

(B) The HCF shall have the ancillary and support services necessary for the provision of the HCF’s services.

(C) The HCF shall document and review any complications and adverse events which arise during the provision of the facility’s service.

(D) The HCF shall establish and follow written infection control policies and procedures for the surveillance, control and prevention and reporting of communicable disease organisms by both the contact and airborne routes which shall be consistent with current infection control guidelines, issued by the United States centers for disease control. The policies and procedures shall address:

(1) The utilization of protective clothing and equipment;

(2) The storage, maintenance and distribution of sterile supplies and equipment;

(3) The disposal of biological waste; including blood, body tissue; and fluid in accordance with Ohio law;

(4) Universal precautions/body substance isolation or equivalent; and

(5) Tuberculosis and other airborne diseases.

(E) The HCF shall maintain and operate equipment in a safe manner and in accordance with the manufacturer’s instructions.

(F) The HCF shall provide the patient or the patient’s representative:

(1) Instruction and education regarding the services to be performed;

(2) Written information about how to obtain appointments and needed services both during and after the HCF’s normal hours of operation; and

(3) Verbal and written instructions for post-treatment care and procedures for obtaining emergency care.

(G) The HCF shall comply with rule 3701-3-03 of the Administrative Code pertaining to reportable disease notification.

(H) The HCF shall require that each physician practicing in the HCF complies with any provision of the Revised Code related to obtaining informed consent from a patient and the policies and procedures of the HCF.

(I) If an HCF finds that a physician practicing at the HCF does not comply with any provision of the Revised Code related to the obtaining of informed consent from a patient, the HCF shall take reasonable steps to ensure that the physician does not continue the practice at the facility.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Each HCF shall:

(1) Have a certificate of use and occupancy, from a local, certified building department or by the department of commerce as meeting applicable requirements of Chapters 3781. and 3791. of the Revised Code and any rules adopted under them or obtain documentation from the appropriate building authority that the HCF is not regulated by the state building code; and

(2) Comply with the applicable provisions of Chapter 3737. of the Revised Code and the rules adopted under it.

(B) The HCF shall be maintained in a safe and sanitary manner.

(C) The HCF shall develop a disaster preparedness plan including evacuation in the event of a fire. The HCF shall review evacuation procedures at least annually, and conduct practice drills with staff at least once every six months.

(D) Each HCF shall label, store and dispose all poisons, hazardous wastes and flammable materials in a safe manner, and in accordance with state and federal laws and regulations.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 6/27/96, 9/5/2002

(A) The HCF shall maintain a medical record for each patient that documents, in a timely manner and in accordance with acceptable standards of practice, the patient’s needs and assessments, and services rendered. Each medical record shall be legible and readily accessible to staff for use in the ordinary course of treatment.

(B) The HCF shall not disclose individual medical records except as provided by state and federal laws and regulations.

(C) The HCF shall systematically review the records for conformance with acceptable standards of practice and the requirements of Chapter 3701-83 of the Administrative Code.

(D) The HCF shall maintain an adequate medical record keeping system and take appropriate measures to ensure the confidentiality of patient medical records.

(E) The HCF shall maintain medical records as necessary to verify the information and reports required by statute or regulation for at least six years from the date of discharge.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Each HCF shall establish a quality assessment and improvement program designed to systematically monitor and evaluate the quality of patient care, pursue opportunities to improve patient care, and resolve identified problems.

(B) Each HCF shall develop a written plan that describes the quality assessment and improvement program’s objectives, organization, scope, and mechanism for overseeing the effectiveness of monitoring, evaluation, improvement and problem-solving activities.

(C) The quality assessment and improvement program shall do all of the following:

(1) Monitor and evaluate all aspects of care including effectiveness, appropriateness, accessibility, continuity, efficiency, patient outcome, and patient satisfaction;

(2) Establish expectations, develop plans, and implement procedures to assess and improve the quality of care and resolve identified problems;

(3) Establish expectations, develop plans, and implement procedures to assess and improve the health care facility’s governance, management, clinical and support processes;

(4) Establish information systems and appropriate data management processes to facilitate the collection, management, and analysis of data needed for quality improvement, and to comply with the applicable data collection requirements of Chapter 3701-83 of the Administrative Code;

(5) Document and report the status of quality assessment and improvement program to the governing body every twelve months;

(6) Document and review all unexpected complications and adverse events, whether serious injury or death, that arise during an operation or procedure; and

(7) Hold regular meetings, chaired by the medical director of the HCF or designee, as necessary, but at least within sixty days after a serious injury or death, to review all deaths and serious injuries and report findings. Any pattern that might indicate a problem shall be investigated and remedied, if necessary.

(D) Each HCF shall implement a program for proactive assessment of high-risk activities related to patient safety and to undertake appropriate improvements.

(E) The HCF shall report to the director, in a manner and interval prescribed by the director, the data specified in the applicable rules of Chapter 3701-83 of the Administrative Code.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Each HCF shall develop and follow policies and procedures to receive, investigate, and report findings of complaints regarding the quality or appropriateness of services. The documentation of complaints shall, at a minimum, include the following:

(1) The date complaint was received;

(2) The identity, if provided, of the complainant;

(3) A description of complaint;

(4) The identity of persons or facility involved;

(5) The findings of the investigation; and

(6) The resolution of the complaint.

(B) The HCF shall post the toll free complaint hotline of the department’s complaint unit in a conspicuous place in the HCF.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.12

Rule Amplifies: 3702.30

Prior Effective Dates: 1/13/1996

(A) The director may grant a variance or waiver from any building or safety requirement established by Chapter 3701-83 of the Administrative code, unless the requirement is mandated by statute.

(B) An HCF seeking a variance or waiver must submit a written request to the director. Such written request must include the following information:

(1) the specific nature of the request, and the rationale for the request;

(2) the specific building or safety requirement in question, with a reference to the relevant administrative code provision;

(3) the time period for which the variance or waiver is requested;

(4) if the request is for a variance, a statement of how the HCF will meet the intent of the requirement in an alternative manner; and

(5) if the request is for a waiver, a statement regarding why application of the requirement will cause undue hardship to the HCF and why granting the waiver will not jeopardize the health and safety of any patient.

(C) Upon written request of the HCF the director may grant:

(1) A variance if the director determines that the requirement has been met in an alternative manner; or

(2) A waiver if the director determines that the strict application of the license requirement would cause an undue hardship to the HCF and that granting the waiver would not jeopardize the health and safety of any patient.

(D) The director may stipulate a time period for which a variance or a waiver is to be effective and may establish conditions that the HCF must meet for the variance or waiver to be operative. Such time period may be different than the time period sought by the HCF in the written variance or waiver request.

(E) The director may establish conditions that the HCF must meet for the variance or waiver to be operative. The director may, in his discretion, rescind the waiver or variance at any time upon determining that the HCF is not meeting such conditions.

(F) The refusal of the director to grant a variance or waiver, in whole or in part, shall be final and shall not be construed as creating any rights to a hearing under Chapter 119. of the Revised Code.

(G) The granting of a variance or waiver by the director shall not be construed as constituting precedence for the granting of any other variance or waiver. All variance and waiver requests shall be considered on a case-by-case basis.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

For the purposes of rules 3701-83-15 to 3701-83-22 of the Administrative Code, the following definitions shall apply:

(A) “Ambulatory surgical facility” or “ASF” means a facility whether or not a part of the same organization as a hospital, which is located in a building distinct from another in which inpatient care is provided, and to which any of the following apply:

(1) Outpatient surgery is routinely performed in the facility and the facility functions separately from a hospital’s inpatient surgical service or emergency department, and from the offices of private physicians, podiatrists, and dentists;

(2) Anesthesia is administered in the facility by an anesthesiologist or certified registered nurse anesthetist and the facility functions separately from a hospital’s inpatient surgical service or emergency department, and from the offices of private physicians, podiatrists, and dentists;

(3) The facility applies to be certified by the United States health care financing administration as an ambulatory surgical center for purposes of reimbursement under Part B of the medicare program, Part B of Title XVIII of the “Social Security Act” 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended;

(4) The facility applies to be certified by a national accrediting body approved by the health care financing administration for purposes of deemed compliance with the conditions for participating in the medicare program as an ambulatory surgical facility;

(5) The facility bills or receives from any third-party payer, governmental health care program, or other person or government entity any ambulatory surgery facility fee that is billed or paid in addition to any fee for professional services.

(6) The facility is held out to any person or government entity as an ambulatory surgical facility or similar facility by means of signage, advertising, or other promotional efforts.

(B) “Ambulatory surgical facility fee” means a fee for certain overhead costs associated with providing surgical services in an outpatient setting, but does not include any additional payment in excess of a professional fee that is provided to encourage physicians, podiatrists, and dentists to perform certain surgical procedures in their office or their group practice’s office rather than a health care facility, if the purpose of the additional fee is to compensate for additional cost incurred in performing office-based surgery. A fee is an ambulatory surgical facility fee only if it directly or indirectly pays for costs associated with any of the following:

(1) Use of operating and recovery rooms, preparation areas, and waiting rooms and lounges for patients and relatives;

(2) Administrative functions, record keeping, housekeeping, utilities, and rent;

(3) Services provided by nurses, orderlies, technical personnel, and others involved in patient care related to providing surgery.

(C) “Anesthesia” means total or partial loss of sensation, tactile sensibility, or protective reflexes, with or without the loss of consciousness, produced by a pharmacological or non-pharmacological agent or method, or combination thereof.

(D) “Anesthesia qualified dentist” means a dentist who holds a permit of authorization to utilize general anesthesia issued pursuant to rule 4715-5-05 of the Administrative Code.

(E) “Anesthesiologist” means a physician who has completed a residency training program in anesthesiology accredited by the accreditation council of graduate medical education or the American osteopathic association.

(F) “Certified registered nurse anesthetist” or “CRNA” means a registered nurse who is authorized to practice as a certified registered nurse anesthetist under section 4723.41 of the Revised Code and is credentialed and privileged by the HCF to administer anesthetics to patients within his or her scope of practice.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 7/11/96, 8/26/2002

(A) As required under paragraph (E) of rule 3701-83-03 of the Administrative Code, each ASF shall have a governing body.

(B) The governing body shall:

(1) At least every twenty-four months review, update, and approve the surgical procedures that may be performed at the center and maintain an up-to-date listing of these procedures;

(2) Grant or deny clinical (medical-surgical and anesthesia) privileges, in writing and reviewed or re-approved at least every twenty-four months, to physicians and other appropriately licensed or certified health care professionals based on documented professional peer advice and on recommendations from appropriate professional staff. These actions shall be and based on documented evidence of the following:

(a) Current licensure and certification, if applicable;

(b) Relevant education, training, and experience; and

(c) Competence in performance of the procedures for which privileges are requested, as indicated in part by relevant findings of quality assessment and improvement activities and other reasonable indicators of current competency.

(3) In the case of an ASF owned and operated by a single individual, provide for an external peer review by an unrelated person not otherwise affiliated or associated with the individual. The external peer review shall consist of a quarterly audit of a random sample of surgical cases.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) The ASF shall only admit patients who do not require planned inpatient care and who shall be kept in the ASF less than twenty-four hours. The twenty-four hour period begins at the start of the operation or procedure, or the induction of anesthesia, whichever is first. The twenty four hour period may include an overnight stay if such stay meets all of the conditions set forth in this rule and does not extend the length of time a patient remains in the ASF.

(B) Prior to operation or procedure, each patient shall have a comprehensive medical history and physical exam performed or updated, along with associated pre-procedure studies. The different components of the history and physical may be performed by different health care professionals, consistent with the type of information required and the professionals’ scope of practice, as defined by applicable law. This history and physical exam shall document the pre-operative diagnosis and the procedure to be performed and shall become part of the patient’s medical record prior to surgery.

(C) Documentation, as contained in paragraphs (A)(3), (C)(1), and (C)(7) to (C)(9) of rule 3701-83-21 of the Administrative Code shall be in a patient’s medical record prior to surgery.

(D) Immediately before surgery the attending physician, podiatrist, or dentist shall examine the patient to evaluate the risks of the procedure to be performed. Each patient shall also be examined by an anesthesiologist, physician, podiatrist, anesthesia qualified dentist, or CRNA, as appropriate, to evaluate the risks of anesthetics and for proper anesthesia recovery before discharge from post anesthesia care.

(E) The attending or other designated physician, podiatrist, or anesthesia qualified dentist shall discharge a patient meeting discharge criteria from the ASF within twenty-four hours of the start of the operation or procedure, or induction of anesthesia, whichever is first, or transfer the patient to a setting appropriate for the patient’s needs.

(F) Patients transported to a hospital shall be accompanied by their medical records that are of sufficient content to ensure continuity of care.

(G) Prior to discharge, the ASF shall provide each patient with both verbal and written instructions for post-treatment care and procedures for obtaining emergency care.

(H) The physician, podiatrist, dentist, or a nurse shall ensure that the patient or patient’s representative acknowledge, in writing, receipt of the physician’s, podiatrist’s, or dentist’s written discharge instructions.

(I) The ASF shall discharge a patient only if accompanied by a responsible person, unless the attending or discharging physician, podiatrist, or anesthesia qualified dentist determines that the patient does not need to be accompanied and documents the circumstances of discharge in the patient’s medical record.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13. 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 6/27/96, 9/5/2002

(A) Each ASF shall maintain qualified nursing and physician staff, and qualified dental staff, as appropriate for the services provided. Each ASF shall, based on the services provided and the number of patients served, maintain a sufficient number of staff and other personnel and an appropriate schedule of staff time to meet the needs of its patients in a timely manner.

(B) Each ASF shall have a medical director and an administrator as defined in rule 3701-83-01 of the Administrative Code. If the ASF limits its services:

(1) To dental/oral and maxillofacial surgery, a dentist may serve as the medical director; or

(2) To podiatric surgery, a podiatrist may serve as the medical director.

(C) Each ASF shall have a director of nursing who is an RN with experience in surgical and recovery room nursing care. The director of nursing shall be responsible for the management of nursing services.

(D) The ASF shall only grant privileges to physicians, podiatrists, dentists and CRNAs:

(1) Whose professional license or certification is maintained in good standing; and

(2) Who meet other guidelines as determined by the governing body.

(E) At all times when patients are receiving treatment or recovering from treatment until they are discharged from post anesthesia care, the ASF shall have at least one member of the physician staff, podiatry staff, or dental staff, as applicable, present and on duty in the ASF.

(F) At all times when patients are receiving treatment or recovering from treatment until they are discharged, the ASF shall meet the following requirements:

(1) At least two nurses shall be present and on duty in the ASF, at least one of whom shall be an RN and at least one of whom is current in advanced cardiac life support and who shall be present and on duty in the recovery room when patients are present;

(2) In addition to the requirement of paragraph (F)(1) of this rule, at least one RN shall be readily available on an on-call basis; and

(3) Sufficient and qualified additional staff to attend to the needs of the patients shall be present.

(G) Each ASF shall maintain the following:

(1) Copies of current Ohio licenses, registrations and certifications shall be kept in the employee’s personnel files or the provider of the ASF shall have an established system to verify and document the possession of current Ohio licenses, registration or other certifications required by law. Licenses of nurses shall be copied in accordance with paragraph (E) of rule 4723-7-09 of the Administrative Code.

(2) Staffing schedules, time-worked schedules, on-call schedules, and payroll records for at least two years.

(H) Each ASF shall provide an ongoing training program for its personnel. The program shall provide both orientation and continuing training to all staff members. The orientation shall be appropriate to the tasks that each staff member will be expected to perform. Continuing training shall be designed to assure appropriate skill levels are maintained and that staff are informed of changes in techniques, philosophies, goals, and similar matters. The continuing training may include attending and participating in professional meetings and seminars.

(I) Each ASF shall require that each physician who practices at the facility complies with any provision of the Revised Code related to the obtaining of informed consent from a patient.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 6/27/96, 9/5/2002

(A) The ASF shall provide medical services, dental services, nursing services, pharmaceutical services, and anesthesia services. Each service shall be provided in a safe, effective manner that is consistent with the needs of the patient.

(B) The ASF shall:

(1) Provide adequate space, equipment, and staff for storage and the administration of drugs in compliance with state and federal laws and regulations.

(2) Establish and implement a program for the control and accountability of drug products throughout the facility and maintain a list of medications that are always available.

(C) The ASF shall:

(1) Ensure that all anesthetics are administered by individuals acting within their licensed scopes of practice.

(2) Maintain an anesthesia record for each patient who receives anesthetics in the facility. This record shall become a part of the patient’s medical record and shall include patient identification data, dosage and duration of anesthesia, and a record of administration of other drugs or therapeutics.

(3) Ensure that, following the administration of general anesthetics, patients are constantly attended by the responsible anesthesiologist, CRNA, anesthesia qualified dentist, physician or podiatrist acting within their scope of practice, or an RN until conscious and in the ambulatory condition normal for him or her.

(D) The ASF shall respond to medical emergencies including emergency cardiac care that may arise in the provision of services to patients.

(E) The ASF shall have a written transfer agreement with a hospital for transfer of patients in the event of medical complications, emergency situations, and for other needs as they arise.

(F) Prior to the surgery, the physician, podiatrist, or dentist, shall obtain a statement documenting informed consent, signed by the patient or patient representative, for the performance of the specific surgical procedure or procedures. This statement shall be made part of the patient’s medical record. The ASF shall ensure that informed consents for surgical procedures have been signed.

(G) The ASF may provide or contract for other services including, but not limited to, laboratory and radiology services.

(H) When a blood supply may be needed for a surgical procedure, the ASF shall:

(1) Have a policy and procedure to obtain blood, blood components, or blood products on a timely basis.

(2) Ensure that blood, blood components or blood products are administered by physicians, anesthesia qualified dentists, or RNs.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 6/27/96, 9/5/2002

(A) Each ASF shall have one or more operating rooms or procedure rooms, each of which is designed and equipped so that the types of surgery conducted can be performed in a manner that protects the health and well-being of all individuals in the area. The recovery area shall be adequately equipped for the proper care of post anesthesia recovery of surgical patients.

(B) Each ASF shall have the following equipment accessible to the operating suite and recovery area:

(1) Adequate resuscitation equipment:

(a) ASFs providing surgical procedures under topical and local infiltration blocks with or without oral or intramuscular preoperative sedation shall have: airways, bag mask respirator, oxygen source, suction equipment, and age-appropriate resuscitative drugs:

(b) ASFs providing surgical procedures performed in conjunction with oral, parenteral, or intravenous sedation or under analgesic or dissociative drugs or providing surgical procedures that require general or regional block anesthesia and support of vital bodily functions shall have: airways, endotracheal tubes, laryngoscope, oxygen delivery capability under positive pressure, suction equipment and suitable resuscitative drugs.

(2) Appropriate monitoring equipment:

(a) Each ASF shall have size-specific blood pressure apparatus and stethoscopes, electrocardiogram, oscilloscopes and when pediatric patients are treated, size-specific emergency equipment and medications;

(b) ASFs performing surgical procedures in conjunction with oral, parenteral, or intravenous sedation or under ananalgesic or dissociative drugs, or performing surgical procedures that require general or regional block anesthesia and support of vital bodily functions shall have a defibrillator, pulse oximeter with alarm, and temperature monitor.

(c) ASFs using inhalation anesthesia shall have an anesthesia machine.

(3) Each ASF shall have suitable surgical instruments customarily available for the planned surgical procedure in the operating suite.

(4) Each ASF shall have in the recovery room, an emergency call system that is connected electronically, electrically, by radio transmission or in a like manner and that effectively alerts staff.

(C) Each ASF shall establish and follow a preventive maintenance program which includes periodic calibration, cleaning and adjustment of all equipment in accordance with manufacturer’s instructions. Each ASF using inhalation anesthesia shall develop and follow policies and procedures for monitoring the anesthesia machine which are consistent with the standards recommended by the American society of anesthesiologists.

(D) Each ASF shall have appropriate ventilation and humidity levels in order to minimize the risk of infection and to provide for the safety of the patient.

(E) Each ASF shall have emergency power available in operative and recovery areas.

(F) Each ASF shall have separate closed off and distinct areas used as waiting rooms, recovery rooms, treatment rooms, toilet facilities, and storage rooms. The ASF and another entity may not mix functions and operations in a common space during concurrent or overlapping hours of operation. Operating and recovery rooms must be used exclusively for surgical procedures.

(G) New construction, alterations or renovations that provide space for operating rooms may not be used or occupied until authorization for such occupancy has been received by the ASF from the department.

(H) Each ASF shall develop and follow policies and procedures for the storage and use of all medical gases in accordance with the requirements of the national fire protection association (NFPA) 99.

(I) If the ASF uses medications or drugs that may induce malignant hyperthermia, it shall have policies and procedures in place, as well as equipment and medication available, to treat it.

(J) Each ASF shall have appropriate intravenous fluids and administration equipment.

(K) Each ASF shall have sufficient and appropriate stretchers and wheelchairs for the services performed.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3701.13, 3702.30

Rule Amplifies: 3702.12, 3701.13, 3702.30

Prior Effective Dates: 9/5/2002

Each ASF medical record shall contain at least the following information as applicable for the surgery to be performed:

(A) Admission data:

(1) Name, address, date of birth, gender, and race or ethnicity;

(2) Date and time of admission; and

(3) Pre-operative diagnosis, which shall be recorded prior to or at the time of admission.

(B) History and physical examination data:

(1) Personal medical history, including but not limited to allergies, current medications and past adverse drug reactions;

(2) Family medical history; and

(3) Physical examination.

(C) Treatment data:

(1) Physician’s, podiatrist’s or dentist’s orders;

(2) Physician’s podiatrist’s or dentist’s notes;

(3) Physician assistant’s notes, if applicable;

(4) Nurse’s notes;

(5) Medications;

(6) Temperature, pulse, and respiration;

(7) Any special examination or report, including but not limited to, x-ray, laboratory, or pathology reports;

(8) Signed informed consent form;

(9) Evidence of advanced directives, if applicable;

(10) Operative record;

(11) Anesthesia record, if applicable; and

(12) Consultation record, if applicable.

(D) Discharge data:

(1) Final diagnosis;

(2) Procedures and surgeries performed;

(3) Condition upon discharge;

(4) Post-treatment care and instructions; and

(5) Attending physician’s, podiatrist’s or dentist’s signature.

(E) Other information required by law.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

As part of the quality assessment program required under paragraph (A) of rule 3701-83-12 of the Administrative Code, each ASF shall collect and maintain the following data on an annual basis and shall report such data to the director upon request:

(A) The total number of patient visits;

(B) The total number of patient transfers to a hospital and the reason why;

(C) The total number of deaths in the ASF; and

(D) The total number of deaths resulting either from the surgery or from surgical complications that occur in the ASF.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

For purposes of rules 3701-83-23 and 3701-83-24 of the Administrative Code the following definitions shall apply:

(A) “Chronic maintenance dialysis” means the regular provision of dialysis for an end stage renal disease patient with any level of patient involvement.

(B) “Dialysis” means a process by which dissolved substances are removed from a patient’s body by diffusion from one fluid compartment to another across a semipermeable membrane.

(C) “End stage renal disease patient” or “patient” means an individual who is at a stage of renal impairment that appears irreversible and permanent and who requires a regular course of dialysis or renal transplantation to ameliorate uremic symptoms and maintain life.

(D) “Freestanding dialysis center” or “dialysis center” means a facility that provides chronic maintenance dialysis to end stage renal disease patients on an outpatient basis, including the provision of dialysis services in the patient’s place of residence. A freestanding dialysis center does not include the following:

(1) A hospital or other entity that performs dialysis services that are reviewed and accredited or certified as part of the hospital’s accreditation or certification as required by section 3727.02 of the Revised Code; and

(2) Home dialysis as defined in paragraph (E) of this rule.

(E) “Home dialysis” means dialysis performed by an appropriately trained patient, with or without minimal assistance, at the patient’s place of residence.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Each dialysis center shall:

(1) Develop and follow policies and procedures for the provision of care consistent with national standards of care or guidelines;

(2) Develop and follow protocols for the prevention of disease transmission utilizing standards of care or guidelines for dialysis patients;

(3) Provide services in accordance with the clinical capabilities of the facility;

(4) Develop and follow policies and procedures for the administration of medication;

(5) Develop and follow policies and procedures for the provision of water that are consistent with the association for advancement of medical instrumentation (AAMI) standards, including criteria for the biological and chemical composition of the water;

(6) Develop and follow policies and procedures for the re-use of hemodialyzers consistent with the association for advancement of medical instrumentation (AAMI) standards;

(7) Develop and follow policies and procedures for direct care staff to notify appropriate health care professionals of problems related to the provision of dialysis care;

(8) Develop and follow emergency plans to include patient self disconnect; and

(9) Provide each patient with both verbal and written instructions for post treatment care and procedures for obtaining emergency care.

(B) Each dialysis center shall utilize a coordinated and integrated interdisciplinary team, and the patient, to develop a long term program and patient care plan. The care plan shall be based on an evaluation of the nature of the patient’s illness, the treatment modality prescribed, and an assessment of the patient’s needs. The care plan shall address the patient’s physical, medical, dietary, psychosocial, functional, and rehabilitation needs. The care plan shall be reviewed at least semi-annually and the long-term program shall be revised at least annually.

(C) Each dialysis center shall provide the necessary ancillary and support services to meet the dialysis needs of patients and in accordance with the patients’ care plan.

(D) No dialysis center may set up dialysis stations for patient use which exceed the authorized maximum number of licensed dialysis stations.

(E) Each dialysis center shall maintain an isolation station.

(F) Each dialysis center shall provide the patient or the patient’s representative in writing the following:

(1) Information regarding the policies, procedures, and mission statement of the dialysis center and the services provided at the facility;

(2) Information concerning the services to be performed;

(3) Information about the complaint policies and procedures required by rule 3701-83-13 of the Administrative Code; and

(4) Information regarding the center’s policy on advanced directives.

(G) Each dialysis center shall maintain operational logs. These logs shall include records for:

(1) The dialysate solution delivery system;

(2) The blood circuit system;

(3) The reprocessing system;

(4) The water treatment system; and

(5) The water treatment quality.

(H) Each dialysis center shall maintain records of water test results and necessary treatment for two years.

(I) Each dialysis center shall maintain an appropriately stocked emergency tray or cart consistent with the types of services being provided.

(J) Each dialysis center shall ensure that all drugs and supplies have not exceeded the expiration date.

(K) Each dialysis center shall develop and follow procedures to respond to medical emergencies that may arise in the provision of services to patients, including emergency cardiac care.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 9/5/2002

(A) Each dialysis center shall maintain the following:

(1) Copies of current Ohio licenses, registrations and certifications shall be kept in the employee’s personnel files or the provider of the dialysis center shall have an established system to verify and document the possession of current Ohio licenses, registrations or other certifications required by law. Licenses of nurses shall be copied in accordance with paragraph (D) of rule 4723-7-09 of the Administrative Code; and

(2) Staffing schedules, time-worked schedules, on-call schedules, and payroll records for at least two years.

(B) Each dialysis center shall provide an ongoing training program for its personnel. The program shall provide both orientation and continuing training to all staff members. The orientation shall be appropriate to the tasks that each staff member will be expected to perform. Continuing training shall be designed to assure appropriate skill levels are maintained and that staff are informed of changes in techniques, mission, goals, policies and procedures including those related to infection control and blood-borne pathogens, and similar matters. The continuing training may include attending and participating in professional meetings and seminars.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 9/5/2002

Each patient medical record required by paragraph (A) of rule 3701-83-11 of the Administrative Code shall contain at least the following information:

(A) Patient information including:

(1) Name, address, date of birth, gender, and race or ethnicity;

(2) History and physical examination data including allergies, current medications, past adverse drug reactions, and family medical history;

(3) Diagnosis; and

(4) Dialysis prescriptions.

(B) Treatment data including;

(1) Long term program and patient care plan;

(2) Progress notes; and

(3) Treatment notes including dates and times the patient was on or off dialysis, pre-dialysis safety checks, vital signs monitoring during dialysis, and notations of adverse reactions.

(C) Medication administration.

(D) Any special examination or report, including x-ray, laboratory, or pathology report.

(E) Signed consent for treatment form.

(F) Documentation indicating that the patient or patient’s representative received in writing the following:

(1) Information on complaint policies and grievance procedures;

(2) Information regarding the center’s policy on advanced directives; and

(3) Information about the services to be performed.

(G) Documentation indicating that the patient or patient’s representative received information about:

(1) Emergency self disconnect; and

(2) Measures to be taken in the event of an at home post-treatment medical emergency.

(H) Discharge data including, condition upon discharge, and post-discharge care and instructions.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 9/5/2002

(A) In addition to the requirement in rule 3701-83-09 of the Administrative Code, each dialysis center shall develop and follow written policies and procedures for preventing and controlling infections. The policies and procedures must include the aseptic and isolation techniques to be used and address the use of the isolation station.

(B) Each dialysis center shall establish and follow a preventive maintenance program that includes periodic calibration, cleaning and adjustment of all equipment in accordance with manufacturer’s instructions.

(C) Each dialysis center shall:

(1) Culture and conduct water specimen analysis used for dialysis purposes at least every thirty days for bacteria;

(2) Analyze water used for dialysis purposes at least every one hundred and eighty days for chemicals;

(3) Treat water as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques.

(D) Each dialysis center shall conduct routine surveillance of patients and staff for hepatitis B using the most sensitive test methods available. Patients and new employees must be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (HBsAb) before or at the time they enter the unit in order to determine their serologic status for surveillance purposes.

(E) Each dialysis facility shall investigate reports of infections associated with the provision of dialysis services. Efforts shall be made to determine the origin of any such infection and remedial action shall be taken to prevent recurrence.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

As part of the quality assessment and improvement system required under rule 3701-83-12 of the Administrative Code, each freestanding dialysis center shall provide to the director, upon request, copies of data reports provided to the “renal network” designated by the United States centers for medicare and medicaid services to include the state of Ohio or any portion of the state of Ohio pursuant to 42 C.F.R. section 405.2112. All patient specific information submitted to the director under this paragraph that identifies a patient shall be maintained in a confidential manner.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

For purposes of rules 3701-83-25 to 3701-83-32 of the Administrative Code the following definitions apply:

(A) “Freestanding inpatient rehabilitation facility” or “inpatient rehabilitation facility” means a facility operated for the exclusive purpose of providing specialized rehabilitation services, on an inpatient basis, to persons with functional limitations or chronic disabling conditions who are in a medically stable condition and have the potential to achieve significant improvement in independent functioning. Freestanding inpatient rehabilitation facility does not include the following:

(1) A facility established and operated for the primary purpose of providing rehabilitation treatment services for alcohol or drug abuse;

(2) A general hospital as defined in rule 3701-59-01 of the Administrative Code or other entity that provides rehabilitation services that are reviewed and accredited or certified as part of a general hospital’s accreditation or certification as required by section 3727.02 of the Revised Code; and

(3) A nursing home licensed under Chapter 3721. of the Revised Code, a skilled nursing facility that meets the requirements for participation in medicare, or a nursing facility that meets the requirements for participation in medicaid.

(B) “Interdisciplinary team” means a group of individuals representing appropriate licensed disciplines providing an integrated approach to serving the rehabilitation needs specific to a particular patient in an inpatient rehabilitation facility.

(C) “Occupational therapist” means a person licensed to practice occupational therapy pursuant to section 4755.07 of the Revised Code.

(D) “Physical therapist” means a person licensed to practice physical therapy pursuant to section 4755.44 of the Revised Code.

(E) “Psychologist” means a person licensed to practice psychology pursuant to Chapter 4732. of the Revised Code.

(F) “Social worker” means a person licensed to practice social work pursuant to Chapter 4757. of the Revised Code.

(G) “Speech-language pathologist” means a person licensed to practice speech pathology pursuant to Chapter 4753. of the Revised Code.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.12

Rule Amplifies: 3702.30

Prior Effective Dates: 1/13/1996

(A) Each inpatient rehabilitation facility shall provide services that meet the needs of its patients and that are in accordance with the patient’s plan of care. The facility shall provide the patient or the patient’s representative:

(1) Information regarding the policies, procedures, and philosophy of the inpatient rehabilitation facility and the services provided at the facility; and

(2) Information concerning the services to be performed.

(B) Each inpatient rehabilitation facility shall:

(1) Develop and follow current care protocols utilizing accepted standards of care;

(2) Provide services in accordance with applicable state and federal laws and regulations; and

(3) Provide services in accordance with the clinical capabilities of the facility.

(C) The inpatient rehabilitation facility shall utilize a coordinated and integrated, interdisciplinary approach to assess patient needs and to provide treatment and evaluation of physical, psychosocial and cognitive deficits. The inpatient rehabilitation facility shall provide each patient with the services of an interdisciplinary team, directed by a physician who is board certified in physical medicine and rehabilitation or a specialty appropriate to the services provided or has comparable qualifications and experience, as determined by the medical director. The interdisciplinary team shall participate in the provision and management of rehabilitation and medical services.

(D) The inpatient rehabilitation facility shall provide the services identified by the interdisciplinary team for the individual patient, as set forth in the following documents:

(1) The preliminary assessment required by paragraph (C) of rule 3701-83-27 of the Administrative Code.

(2) The comprehensive inpatient rehabilitation evaluation and the treatment plan required by paragraphs (A) and (B) of rule 3701-83-28 of the Administrative Code.

(3) The discharge plan required by paragraph (E) of rule 3701-83-28 of the Administrative Code.

(E) Each inpatient rehabilitation facility shall respond to medical emergencies that may arise in the provision of services to patients, including emergency cardiac care.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 9/5/2002

(A) The inpatient rehabilitation facility shall develop written criteria for admission of patients to the facility that includes a description of programs and services available at the facility.

(B) The inpatient rehabilitation facility shall not admit a patient to the facility unless the following conditions are met:

(1) The patient is able to tolerate a minimum of three hours of rehabilitation therapy, five days per week;

(2) The patient is medically stable; and

(3) The patient’s prognosis indicates a progressively improved medical condition with the potential for increased independence.

(C) The inpatient rehabilitation facility shall complete a written preliminary assessment of each patient within forty-eight hours of admission. An interdisciplinary team shall perform the preliminary assessment that shall include at least the following:

(1) An evaluation of the appropriateness of placement in relation to the services available at the particular facility; and

(2) Identification of the immediate needs of the patient.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) The inpatient rehabilitation facility shall perform a written comprehensive inpatient rehabilitation evaluation for each patient admitted to the facility. The comprehensive inpatient rehabilitation evaluation shall be developed by the interdisciplinary team and include the following:

(1) Purpose and source of referral;

(2) Summary of the patient’s clinical condition;

(3) Functional strengths and limitations of the patient; and

(4) A determination of the patient’s need for the following services:

(a) Medical;

(b) Nursing;

(c) Rehabilitation nursing;

(d) Dietary;

(e) Occupational therapy;

(f) Physical therapy;

(g) Prosthetics and orthotics;

(h) Psychological assessment and therapy;

(i) Therapeutic recreation;

(j) Rehabilitation medicine; and

(k) Speech-language pathology.

(B) The inpatient rehabilitation facility shall develop a written treatment plan for each patient admitted to the facility. The treatment plan shall be developed by the interdisciplinary team and shall include findings and services identified in the comprehensive inpatient evaluation completed in accordance with paragraph (A) of this rule, and information regarding the following:

(1) Level of function prior to the disabling condition;

(2) Current functional limitations;

(3) Specific service needs;

(4) A summary of the treatments to be provided;

(5) Supports and adaptations to be provided;

(6) Specific treatment goals and expected outcomes;

(7) Disciplines to be utilized and their respective responsibilities for implementing the treatment plan; and

(8) Anticipated time frames for achieving treatment goals and expected outcomes.

(C) The treatment plan shall be periodically reviewed by the interdisciplinary team as indicated, but not less than once every seven days. The periodic review of the treatment plan shall be documented and shall include documentation of at least the following:

(1) Progress toward achieving defined goals; and

(2) Any changes in the treatment plan.

(D) The inpatient rehabilitation facility shall designate an individual to be case manager for each patient. The case manager shall be responsible for coordination of the patient’s treatment plan. Any member of the interdisciplinary team may be designated as the case manager.

(E) The inpatient rehabilitation facility shall develop a written discharge plan for each patient admitted to the facility which is based on the treatment goals and expected outcomes defined in the treatment plan. The discharge plan shall:

(1) Identify the expected care setting for the patient after discharge;

(2) Be revised periodically based on the patient’s progress in achieving the defined goals and any changes in treatment; and

(3) Document any referrals provided to the patient.

(F) The inpatient rehabilitation facility shall complete and initiate implementation of the comprehensive inpatient evaluation, the treatment plan, and the discharge plan within seventy-two hours of admission.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.12

Rule Amplifies: 3702.30

Prior Effective Dates: 1/13/1996

(A) The inpatient rehabilitation facility shall provide or arrange for the services of personnel in sufficient number and with appropriate qualifications to meet the rehabilitation and medical needs of the patients being served, an appropriate schedule of such personnel to meet the needs of patients in a timely manner, and provide services to the individual patient as required under rule 3701-83-26 of the Administrative Code.

(B) At a minimum, the inpatient rehabilitation facility shall maintain the following staff:

(1) A medical director to be responsible for overseeing and managing medical and rehabilitation services. The medical director shall be a physician who has appropriate experience and training to provide rehabilitation physician services, as demonstrated by at least one of the following:

(a) Certification as a physiatrist by the American board of physical medicine and rehabilitation or the American osteopathic board of rehabilitation medicine;

(b) Formal residency in physical medicine and rehabilitation;

(c) Fellowship in rehabilitation for at least one year; or

(d) At least two years experience in providing inpatient rehabilitation services.

(2) A director of nursing to be responsible for managing nursing services. The director of nursing shall be an RN with appropriate experience and training in rehabilitation nursing as demonstrated by the following;

(a) Certification as a rehabilitation nurse by the American rehabilitation nursing certification board; or

(b) At least three years experience in rehabilitation nursing.

(3) A sufficient number of nurses, physical therapists, occupational therapists, speech-language pathologists, social workers and psychologists to meet the needs of patients and provide necessary services.

(C) Any licensed professional may be used to meet the needs of patients and provide necessary services consistent with the licensed professional’s scope of practice as defined by applicable law.

(D) Each inpatient rehabilitation facility shall maintain the following:

(1) Copies of current Ohio licenses, registrations and certifications shall be kept in the employee’s personnel files or the provider of the inpatient rehabilitation facility shall have an established system to verify and document the possession of current Ohio licenses, registrations, or other certifications required by law. Licenses of nurses shall be copied in accordance with paragraph (E) of rule 4723-7-09 of the Administrative Code.

(2) Staffing schedules, time-worked schedules, on-call schedules, and payroll records for at least two years.

(E) Each inpatient rehabilitation facility shall provide an ongoing training program for its personnel. The program shall provide both orientation and continuing training to all staff members. The orientation shall be appropriate to the tasks that each staff member will be expected to perform. Continuing training shall be designed to assure appropriate skill levels are maintained and that staff are informed of changes in techniques, philosophies, goals, and similar matters. The continuing training may include attending and participating in professional meetings and seminars.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) Each inpatient rehabilitation facility shall have patient bedrooms that, at a minimum, meet the following requirements:

(1) Sufficient open floor space shall be provided to allow each patient or personnel to easily maneuver a wheelchair, and transfer each patient from the wheelchair to the bed;

(2) Maximum bedroom capacity shall be no more than four patients;

(3) A call system that is connected electrically, electronically, by radio frequency transmission, or in a like manner and that:

(a) Provides for independent operation by each patient from the bed; and

(b) Effectively alerts the staff member or members on duty of emergencies or patient needs;

(4) A bed of adjustable height with appropriate supports, which facilitates patient transfer from a wheelchair to the bed, shall be provided for each patient; and

(5) Appropriate furnishings and adequate storage space designed to meet the special needs of rehabilitation patients shall be provided for each patient.

(B) Each inpatient rehabilitation facility shall provide the following structural features:

(1) Flooring shall be designed to minimize slipping;

(2) Patient bathrooms shall:

(a) Have sufficient space to allow private use of hand washing, toilet, and bathing or shower facilities by a patient in a wheelchair, with an assisting attendant; and

(b) Be equipped with grab bars and appropriate supports so that physically disabled patients may use toilet, hand washing, and bathing or shower facilities;

(c) Have a call system that is connected electrically, electronically, by radio frequency transmission, or in a like manner that effectively alerts the staff member or members on duty of emergencies or patient needs.

(3) Hand rails on both sides of corridors, ramps, and stairs in areas used by patients;

(4) Doors to be used by patients shall be wide enough to accommodate wheelchairs;

(5) Adequate space designated for group recreation and dining designed to accommodate patients in wheelchairs; and

(6) Adequate and appropriate space for the rehabilitation treatment services to be provided in the facility that shall facilitate the treatment goals of the persons served.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

(A) The inpatient rehabilitation facility shall have equipment and supplies of a type and quantity sufficient to meet the needs of individual patients and to provide services in accordance with rule 3701-83-26 of the Administrative Code.

(B) The inpatient rehabilitation facility shall maintain all equipment and supplies, including such equipment and supplies not used for rehabilitation purposes, in a safe and sanitary manner.

(C) The inpatient rehabilitation facility shall develop, maintain, and implement a preventive maintenance plan for all rehabilitation equipment, designed to assure that the rehabilitation equipment is maintained in a safe manner. The preventive maintenance plan shall include periodic cleaning, adjustment and inspection of all rehabilitation equipment in accordance with manufacturer’s instructions.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.12

Rule Amplifies: 3702.30

Prior Effective Dates: 1/13/1996

As part of the quality assessment and improvement system required under rule 3701-83-12 of the Administrative Code, each inpatient rehabilitation facility shall collect and maintain the following data on an annual basis and shall report such data to the director upon request:

(A) The total number of patients admitted to the facility;

(B) The total number of patients discharged from the facility:

(C) The total number of patients transferred to an acute care setting, such as a hospital;

(D) The total number of patients transferred to a long-term care setting, such as a nursing home;

(E) The total number of patients who achieved discharge goals; and

(F) The total number of patients readmitted to the facility for rehabilitation needs based on the same episode.

R.C. 119.032 review dates: 02/28/2006 and 02/28/2011

Promulgated Under: 119.03

Statutory Authority: 3702.13, 3702.30

Rule Amplifies: 3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/1996, 9/5/2002

As used in rules 3701-83-33 to 3701-83-42 of the Administrative Code:

(A) “Certified nurse-midwife” or “CNM” means an individual with a certificate to practice nurse-midwifery issued under Chapter 4723. of