Chapter 3701-83 Licensing Provisions for Health Care Facilities

3701-83-01 General definitions.

As used in this chapter:

(A) "Accreditation award letter" means an official letter stating the accreditation status and effective dates issued to a health care facility 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, 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 ; 3702.30
Rule Amplifies: 3702.12 ; 3702.13 ; 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-02 Applicability of rules.

(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.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30 , 3702.301
Prior Effective Dates: 1/13/1996, 6/1/07

3701-83-03 General provisions and prohibitions.

(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 current valid 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, osteopathic medicine and surgery, or dentistry.

(F) The HCF shall have an identifiable governing body responsible for the following:

(1) The development and implementation of policies and procedures and a mission statement for the orderly development and management of the HCF;

(2) The evaluation of the HCF's quality assessment and performance improvement program on an annual basis; and

(3) The development and maintenance of a disaster preparedness plan.

(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.

(K) An HCF may arrange for services to be provided through a contract with an outside resource. The HCF shall retain professional management responsibility for contracted services and shall ensure that those services are furnished in a safe an effective manner.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
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, 6/1/07

3701-83-04 License application and renewal procedures.

(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 legal name, address, and telephone number of the entity and the name of every person who has an ownership interest of five per cent 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 residential facility for the mentally ill licensed by the department of mental health under section 5119.22 of the Revised Code;

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

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

(v) 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;

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

(vii) A hospital; or

(viii) 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 (1981); 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 (1981).

(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, or procedure rooms, or both;

(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 rule 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 rule 3701:1-58-43 or 3701:1-58-55 of the Administrative Code

(4) A complete copy of the HCF's current accreditation award letter, 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 award letter, 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 or a permanent decrease in the number of operating or procedure rooms;

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

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

(4) In the case of a freestanding birthing center, there is any increase or a permanent decrease 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 rule 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 rule 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: 06/20/2013
R.C. 119.032 review dates: 04/05/2013 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30 , 3702.31
Rule Amplifies: 3701.12 , 3702.13 , 3702.30 , 3702.31
Prior Effective Dates: 1/13/1996, 6/27/96, 5/23/98, 7/26/01, 9/5/02, 6/1/06, 4/24/11

3701-83-05 Issuance, renewal, and denial of licenses.

(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) The director may renew an HCF license without conducting an onsite inspection if:

(a) The HCF is accredited by a national accrediting body approved by the centers for medicare and medicaid services, as documented by a current award letter from the accrediting body;

(b) The HCF is deemed to meet or exceed the applicable medicare program requirements for health care facilities as set forth in this chapter, as documented by a current award letter from the accrediting body or an approval letter from the centers for medicare and medicaid services; or

(c) The HCF, on the facility's most recent centers for medicare and medicaid services survey, has been determined to be in compliance with the medicare program participation requirements by virtue of a department conducted medicare certification or recertification survey.

(2)

(3) 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, or procedure rooms, or both;

(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.

(f) The license for a freestanding or mobile radiation therapy 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; or

(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 in writing 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 award letter 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: 07/25/2013
R.C. 119.032 review dates: 05/09/2013 and 02/10/2016
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, 5/23/98, 9/5/02, 6/1/06, 4/24/11

3701-83-05.1 Compliance actions, revocation, and operating without a license.

(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.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30 , 3702.32
Rule Amplifies: 3702.12 , 3702.13 , 3702.30 , 3702.32
Prior Effective Dates: 6/1/2006

3701-83-05.2 Civil penalties.

(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.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 ; 3702.30 ; 3702.32
Rule Amplifies: 3702.12 , 3702.13 , 3702.30 , 3702.32
Prior Effective Dates: 6/1/2006

3701-83-06 Inspections.

(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 award letter 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 one thousand seven hundred fifty dollars;

(2) Complaint inspection fee of eight hundred seventy-five dollars;

(3) Follow-up inspection fee of eight hundred seventy-five dollars;

(4) Validation inspection fee of one thousand seven hundred fifty dollars: and

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

(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 nine hundred fifty dollars;

(2) Follow-up inspection fee of four hundred seventy-five dollars;

(3) Complaint fee of four hundred seventy-five dollars; and

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

(H) The director shall provide to each HCF inspected pursuant to section 3702.30 of the Revised Code and paragraph (A) or (E) of this 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 shall forward the total amount of the fee to the director payable to the "Treasurer, State of Ohio" within fifteen days after receiving a statement of the fee issued under paragraph (F) or (G) of this rule.

(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: 10/06/2011
R.C. 119.032 review dates: 07/19/2011 and 02/10/2016
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, 7/26/01, 9/5/02, 6/1/06, 4/24/11

3701-83-07 Patient care policies.

(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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-08 General personnel and staffing requirements.

(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 4723-7-07 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3701.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-09 General service standards.

(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) Standard 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-10 General building and site requirements.

(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., 3783., 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 of all poisons, hazardous wastes and flammable materials in a safe manner, and in accordance with state and federal laws and regulations.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
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, 9/5/02

3701-83-11 General medical records requirements.

(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 protect medical records against theft, loss, destruction, and unauthorized use. The HCF shall have policies and procedures 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.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-12 General quality assessment and performance improvement.

(A) Each HCF shall establish a quality assessment and performance 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 performance 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 performance 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 assessment and performance 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 the quality assessment and performance 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-13 Complaints.

(A) Each HCF shall develop and follow policies and procedures to receive, investigate, and report findings on 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.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12 , 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-14 Variances; waivers.

(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.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-15 Definitions - ambulatory surgical facilities.

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 centers for medicare and medicaid services 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. 301 , as amended;

(4) The facility applies to be certified by a national accrediting body approved by the centers for medicare and medicaid services for purposes of deemed compliance with the conditions for participating in the medicare program as an ambulatory surgical center;

(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 rooms, procedure rooms, 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 4723.43 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
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, 9/5/02, 6/1/06

3701-83-16 Governing body - ambulatory surgical facilities.

(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 facility 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-17 Admission; transfer; discharge - ambulatory surgical facilities.

(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.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
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, 9/5/02, 6/1/06

3701-83-18 Personnel and staffing requirements - ambulatory surgical facilities.

(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 currently certified 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
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, 9/5/02, 6/1/06

3701-83-19 Service standards.

(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. A formal agreement is not required in those instances where the licensed ASF is a provider-based entity of a hospital and the ASF policies and procedures to accommodate medical complications, emergency situations, and for other needs as they arise are in place and approved by the governing body of the parent hospital.

(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.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
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, 9/5/02

3701-83-20 Building and site requirements; equipment - ambulatory surgical facilities.

(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, procedure, 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, procedure, and recovery rooms must be used exclusively for surgical procedures.

(G) New construction, alterations or renovations that provide space for operating rooms or procedure 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 9/5/2002, 6/1/06

3701-83-21 Medical records.

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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-22 Quality assessment and performance improvement system.

As part of the quality assessment and performance improvement 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.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-23 Definitions.

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 either peritoneal dialysis or hemodialysis performed by an appropriately trained patient, with or without minimal assistance, at the patient's place of residence.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-23.1 Services standards.

(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 and infection transmission utilizing standards of care or guidelines for dialysis patients that comply with the regulations for end stage renal disease services contained in 42 C.F.R. 494.30 ( October 1, 2009);

(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 and dialysate that comply with the regulations for end stage renal disease services contained in 42 C.F.R. 494.40 ( October 1, 2009 ) and 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 that comply with the regulations for end stage renal disease services contained in 42 C.F.R. 494.50 ( October 1, 2009) and are 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;

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

(10) Develop and follow policies and procedures for documenting and responding to adverse events. The policies and procedures shall include the course of action to be taken by staff to respond to adverse events, including patient care and evaluation of equipment, water, or dialysate solution. Each dialysis center shall report to the director all adverse events involving the following:

(a) An event requiring emergency treatment, or hospitalization;

(b) An involuntary discharge of a patient;

(c) Contamination of the water or dialysate;

(d) Development of infection or communicable disease; and

(e) An event having a direct or immediate impact on the health, safety, or security of a patient or staff member.

(B) Each dialysis center shall utilize a coordinated and integrated interdisciplinary team, and the patient, to develop and implement a written, individualized, comprehensive 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 if the patient is stable and monthly if the patient is not stable.

(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 plans.

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

(E) No dialysis center shall provide dialysis services for hepatitis B positive patients unless the facility has an in-house isolation room, a designated station or area.

(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 records for:

(1) The dialysate solution delivery system;

(2) The reuse of hemodialyzers and bloodlines;

(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.

Effective: 06/20/2013
R.C. 119.032 review dates: 04/05/2013 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 9/5/2002, 6/29/09, 4/24/11

3701-83-23.2 Personnel and staffing requirements.

(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 (E) of rule 4723-7-07 of the Administrative Code; and

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

(3) Documentation that the facility has offered the hepatitis B vaccination to staff members.

(B) Each dialysis center shall provide an ongoing training program for its personnel. The program shall provide orientation, initial training, and continuing training to all staff members. The orientation and initial training shall be conducted within thirty days of hire and shall be appropriate to the tasks that each staff member will be expected to perform. The initial training shall include instruction in the infection control, equipment, and dialysate policies and procedures required by rules 3701-83-23.1 and 3701-83-23.4 of the Administrative Code. 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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 9/5/2002, 6/29/09

3701-83-23.3 Medical records.

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) A written individualized comprehensive 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.

(I) When a dialysis patient is transferred to another facility or to a facility for inpatient care, the transferring dialysis facility shall send all requested medical records and information to the receiving facility within one day of the transfer.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 9/5/2002, 6/29/09

3701-83-23.4 Infection control and prevention.

(A) In addition to the requirements established in rules 3701-83-09 and 3701-83-23.1 of the Administrative Code, each dialysis center shall develop and follow written policies and procedures for preventing and controlling infections. The policies and procedures shall include, but are not limited to, the following:

(1) The aseptic and isolation techniques to be used;

(2) Use of the isolation room where applicable;

(3) Handling and disposal of biohazardous and potentially infectious waste;

(4) Cleaning and maintenance of equipment;

(5) Cleaning and disinfection of surfaces; and

(6) Use of standard precautions and personal protective equipment.

(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) In addition to the water requirements established in rule 3701-83-23.1 of the Administrative Code, 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.

(1) Each patient must be screened for hepatitis B surface antigen (HBsAG) and hepatitis B surface antibody before admission to the dialysis facility in order to determine their serologic status for surveillance purposes;

(2) New employees must be screened for hepatitis B surface antigen (HBsAG) and hepatitis B surface antibody before or at the time of hire in order to determine their serologic status for surveillance purposes; and

(3) Each dialysis center shall offer the hepatitis B vaccine to all susceptible patients and all staff and document such action in the patient's medical record or the staff member's personnel record.

(E) Each dialysis facility shall investigate and report to the director incidents 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 protect all non-infected patients and prevent recurrence.

(F) Each dialysis facility shall comply with the reporting requirements established by rule 3701-3-03 and paragraph (A)(10) of rule 3701-83-23.1 of the Administrative Code.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 9/5/2002, 6/29/09

3701-83-24 Quality assessment and performance improvement.

(A) Each freestanding dialysis center governing body shall conduct an ongoing, comprehensive, integrated self-assessment of the quality and appropriateness of care provided by the facility, including:

(1) Adequacy of dialysis;

(2) Vascular access;

(3) Medical injuries and medical error identification;

(4) Infection control;

(5) Nutritional status;

(6) Mineral metabolism and renal bone disease;

(7) Anemia management;

(8) Hemodialysizer reuse program where applicable; and

(9) Patient satisfaction and grievance resolution.

(B) The dialysis center shall designate an individual or individuals to be responsible for the quality assessment and performance improvement program. The designee or designees shall implement and report on activities and mechanisms for monitoring the quality of care, identify and resolve problems, and make suggestions for improving care. The designee or designees shall provide their reports to the governing board of the facility.

(C) The dialysis center shall use the findings of the quality assessment and performance improvement program to set priorities for performance improvement, correct identified problems, and to revise facility policies and procedures as necessary. Identified performance problems that threaten the health or safety of patients shall be immediately corrected.

(D) As part of the quality assessment and performance 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 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.

Replaces: 3701-83-24

Effective: 04/24/2011
R.C. 119.032 review dates: 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 11/13/96, 9/5/2002

3701-83-25 Definitions.

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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-26 Service standard and minimum services - inpatient rehabilitation facilities.

(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.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 9/5/2002, 6/1/06

3701-83-27 Admission procedures and preliminary assessment.

(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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-28 Comprehensive inpatient rehabilitation evaluation, treatment plan, and discharge plan.

(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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-29 Personnel and staffing requirements - inpatient rehabilitation facilities.

(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 4723-7-07 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-30 Building and site requirements.

(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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-31 Equipment and supplies.

(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: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-32 Quality assessment and performance improvement.

As part of the quality assessment and performance 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.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-33 Definitions.

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 the Revised Code.

(B) "Director of patient services" means the individual responsible for managing and directing the provision of patient services at the freestanding birth center.

(C) "Family" means the individual or individuals designated by the expectant mother to participate in the birth center's program.

(D) "Freestanding birthing center" or "freestanding birth center" or "center" means a facility, or part of a facility, which provides care during pregnancy, delivery, and the immediate postpartum period to the low-risk expectant mother. "Freestanding birthing center" does not include a hospital registered under section 3701.07 of the Revised Code, or an entity that is reviewed as part of a hospital accreditation or certification program.

(E) "Low-risk expectant mother" means an expectant mother that does not exhibit evidence of:

(1) Diabetes mellitus or gestational diabetes that is not controlled by diet;

(2) Heart disease in which there is any limitation of physical activity and ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain;

(3) Renal disease;

(4) Endocrine disorder, except treated hypothyroidism;

(5) Hematologic disorder;

(6) Severe anemia (hemoglobin less than ten grams/deciliter);

(7) Chronic or gestational hypertension or pre-eclampsia;

(8) Rh factor sensitization or other isoimmunization;

(9) Respiratory disease with significant chance of fetal hypoxia or maternal respiratory distress;

(10) Active herpes;

(11) Prior uterine incisions other than low transverse uterine incisions;

(12) Prematurity (less than thirty-seven weeks gestation);

(13) Human immunodeficiency virus positive;

(14) Known congenital anomalies except for anomalies that do not require services beyond the extent of services the center is authorized by law to provide;

(15) Previous abruption;

(16) Known or suspected drug or alcohol abuse;

(17) Suspected or documented intrauterine growth retardation or fetal macrosomia;

(18) Placental abnormalities;

(19) Multiple births;

(20) Non-vertex presentation; or

(21) Deep venous thrombophlebitis.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 6/327/96, 7/13/03

3701-83-34 General provisions.

(A) Freestanding birth centers are licensed to provide care during pregnancy, birth, and the immediate postpartum period to the low-risk expectant mother and her newborn. Each center shall admit and retain only low-risk expectant mothers anticipating a normal full-term, spontaneous vaginal birth.

(B) Freestanding birth centers shall consult with the attending physician or the CNM in consultation with the physician prior to providing services to low-risk expectant mothers exhibiting evidence of the following:

(1) Previous low transverse cesarean birth;

(2) Previous postpartum hemorrhage requiring treatment by transfusion;

(3) Epilepsy or seizures controlled by medication;

(4) Postmaturity (greater than forty-two weeks gestation);

(5) Grand multiparity;

(6) No prenatal care, sporadic prenatal care, or prenatal care beginning after the first trimester;

(7) Known or suspected drug or alcohol use;

(8) Cephalopelvic disproportion; or

(9) Other medical conditions, except those listed in paragraph (E) of rule 3701-83-33 of the Administrative Code.

(C) Unless medical intervention or non-routine technology can be safely performed or administered by an attending physician at the freestanding birth center, each freestanding birth center shall transfer a patient requiring medical intervention or non-routine technology to a hospital or other appropriate health care setting that can meet the patient's needs. Medical intervention or non-routine technology includes:

(1) Anesthetics other than local anesthetics or pudendal;

(2) Pharmacological augmentation of labor; and

(3) Forceps or vacuum extraction.

(D) If an attending physician at a freestanding birth center performs or administers any medical intervention or non-routine technology under paragraph (C) of this rule, the attending physician must remain with the patient throughout active labor and the immediate postpartum period.

(E) Each freestanding birth center shall provide a home-like environment with adequate space for furnishings, equipment and supplies to provide comfortable accommodations for the number of patients and families served and the personnel providing services.

(F) In addition to the requirements established under paragraph (F) of rule 3701-83-09 of the Administrative Code, each freestanding birth center shall establish and enforce written policies and procedures for the following:

(1) Infection control for patients and families; and

(2) Handwashing for patients and families.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
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, 7/17/03, 6/1/07

3701-83-35 Governing body.

(A) The governing body of each freestanding birth center shall include at least one consumer who is not a health care provider.

(B) The governing body shall:

(1) Meet regularly to execute responsibilities for the operation of the freestanding birth center and shall maintain minutes of meetings;

(2) Maintain records of the names and addresses of all owners and controlling parties, directors, and officers and shall establish a policy on conflict of interest disclosure;

(3) Formulate the mission, goals and long range plan for the center;

(4) Adopt bylaws and establish an organizational structure which clearly delineates lines of authority, responsibility, and accountability;

(5) Adopt policies and procedures for the orderly development, management, and operation of the center to ensure its compliance with applicable rules and regulations;

(6) Appoint the administrator and the director of patient services;

(7) Approve the qualifications of the staff and ensure that all staff have the qualifications required by Chapter 3701-83 of the Administrative Code;

(8) Establish the quality assessment and performance improvement program required under rule 3701-83-12 of the Administrative Code;

(9) Establish policies and procedures for the handling of all legal matters relating to the operation of the center;

(10) Approve all contracts and agreements with individuals or service agencies, such as hospitals, laboratories, emergency transport, consulting specialists, teaching institutions, and organizations conducting research; and

(11) Encourage collaboration and networking with community agencies and special interest groups.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3701.13 , 3702.30
Rule Amplifies: 3702.12 , 3701.13 , 3702.30
Prior Effective Dates: 1/13/1996

3701-83-36 Service standards - freestanding birth centers.

(A) Each freestanding birth center shall provide services that meet the needs of its patients and that are in accordance with the patient's plan of care. The center shall provide the patient or the patient's representative:

(1) Information regarding the policies, procedures, and philosophy of the birth center and the services provided at the center;

(2) Information concerning the services to be performed, including the process of pregnancy, process of labor, birth and postpartum care of the mother and the newborn;

(3) Information about immunizations, vaccines, and State of Ohio newborn screening requirements;

(4) Written information about how to obtain appointments and needed services both during and after normal hours of operation; and

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

(B) Each freestanding birth center shall develop and follow current care protocols utilizing nationally recognized and accepted standards of care while maintaining the holistic environment. Each center shall maintain a current listing of the procedures and protocols and shall provide services in accordance with the clinical capabilities of the birth center.

(C) Each freestanding birth center shall provide intrapartum care that requires minimal intervention and technology including:

(1) Observation of maternal vital signs;

(2) Fetal auscultation;

(3) Nourishment;

(4) Activities;

(5) Comfort measures;

(6) Assessment and evaluation of labor; and

(7) Interaction with the family and support of the family.

(D) Each freestanding birth center shall provide postpartum and newborn care that promotes bonding.

(1) Postpartum care for the mother shall include:

(a) Observation and evaluation of maternal condition;

(b) Education and initiation of newborn feeding;

(c) Self-care assessment and education;

(d) Ensuring that the center's discharge criteria for the mother are met; and

(e) Evaluation of need and provision for administration of immunizations or vaccines and Rh immune globin.

(2) Care for the newborn shall include:

(a) Observation and evaluation of the newborn's condition;

(b) Ensuring that the center's discharge criteria for the newborn are met; and

(c) Evaluation of need and provision for administration of immunizations, vaccines, and screening.

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

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-37 Admission; discharge; transfer - freestanding birth centers.

(A) Each freestanding birth center shall establish policies and procedures for the assessment of expectant mothers. The center shall assess the expectant mother in accordance with the policies and procedures to determine whether she is a low-risk mother and to determine whether a normal full-term, spontaneous vaginal birth is anticipated.

(B) Each freestanding birth center shall establish and follow admission policies and procedures. The center shall upon admission of a patient:

(1) Review the patient's health records;

(2) Observe and document vital signs;

(3) Observe and document labor progress; and

(4) Determine whether diagnostic or screening procedures are required.

(C) Each freestanding birth center shall have a written transfer agreement with a hospital or other appropriate health care setting or provider for the transfer of a mother or newborn in the event of medical complications, emergency situations, or as the need arises. Each center shall maintain the appropriate medical equipment and maintain sufficient staff to provide for the timely transport to a hospital or appropriate health care setting or provider.

(D) Each freestanding birth center shall evaluate the expectant mother to determine whether an intrapartum transfer to a hospital or other appropriate health care setting is necessary. The evaluation shall include an assessment of the following:

(1) Abnormal progress of labor;

(2) Development of maternal complications;

(3) Need for cesarean birth; and

(4) Development of fetal complications.

(E) Each freestanding birth center shall evaluate the mother and newborn to determine whether a postpartum transfer to a hospital or other appropriate health care setting is necessary including evaluation of the following:

(1) Medical complications of the mother; and

(2) Medical complications of the newborn.

(F) Each freestanding birth center shall establish and follow discharge criteria utilizing nationally recognized standards. Prior to discharge each center shall identify a primary care provider for both mother and baby. For postpartum stays less than forty-eight hours, each center shall provide or arrange for the examination of the mother and newborn within seventy-two hours after discharge by a licensed health care provider acting within his or her scope of practice.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 6/27/96, 6/1/06

3701-83-38 Personnel and staffing requirements - freestanding birth centers.

(A) Each freestanding birth center shall have an administrator.

(B) Each freestanding birth center shall have a director of patient services who shall be a physician or a CNM who has contracted with a collaborating physician.

(C) Each freestanding birth center shall establish personnel files for all staff. Each center shall retain the files for two years after an individual is no longer associated with the center. Each personnel file shall be maintained in a manner to ensure confidentiality, as provided by law, and shall contain:

(1) Documentation of the qualifications of the staff to provide services;

(2) A copy of current license, registration, or certification, if applicable or the provider of the freestanding birth center shall have an established system to verify and document the possession of current Ohio licenses, registrations, or other certifications required by law. A copy of the license to practice nursing shall be made in accordance with the requirements of paragraph (E) of rule 4723-7-07 of the Administrative Code;

(3) Documentation of any malpractice insurance carrier, if applicable;

(4) Reports of malpractice claims, if applicable;

(5) The regular performance evaluations required under paragraph (G) of rule 3701-83-08 of the Administrative Code;

(6) Documentation of current certification from the American heart association in cardiac life support or current certification from the American academy of pediatrics in neonatal resuscitation, if applicable; and

(7) Documentation of compliance with paragraph (D) of rule 3701-83-08 of the Administrative Code.

(D) Each freestanding birth center shall provide staff access to reference materials and provide continuing education, orientation, and ongoing training that shall be appropriate to the tasks that each staff member will be expected to perform. Training shall be designed to ensure appropriate skill levels are maintained and that staff are informed of changes in techniques, philosophies, goals, and similar matters. Ongoing training may include attending and participating in professional meetings and seminars and may also include:

(1) Universal precautions and infection control procedures;

(2) Fire, safety and disaster procedures;

(3) Licensure requirements;

(4) The philosophy of the birth center; and

(5) Procedures for the stabilization of newborns from birth to transport.

(E) Each freestanding birth center shall provide information concerning the philosophy of the center to applicants for professional employment.

(F) Each freestanding birth center shall provide for the availability of and access to consulting specialists.

(G) Each freestanding birth center shall maintain a sufficient number of staff on duty and available to meet demands for services routinely provided and an appropriate schedule of staff time to meet the needs of patients in a timely manner. The center shall provide sufficient staff to ensure patient safety and to ensure that no mother in active labor is left unattended.

(H) Each freestanding birth center shall establish and post a schedule for staff and consulting specialists that includes coverage for periods of high demand or emergency.

(I) A staff member who is current in certification from the American heart association in cardiac life support and a second staff member who is current in certification from the American academy of pediatrics in neonatal resuscitation shall be present at each birth.

(J) A physician or CNM shall attend each birth. A physician shall be available for stabilization and care of ill newborns and mothers.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
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, 9/5/02, 6/1/06

3701-83-39 Building and site requirements.

(A) Each freestanding birth center shall provide sufficient space for the number of patients and patient families and staff members to assure privacy for patients and families including:

(1) A waiting room;

(2) An examination room;

(3) A staff area, conference area, or classroom; and

(4) A Family room with a designated play area for children.

(B) Each freestanding birth center shall have a minimum of two birth rooms. The birth room shall:

(1) Be of adequate size and appropriate configuration to provide for the equipment, staff members, supplies and emergency procedures required for the physical and emotional care of the mother, family, and the newborn during birth, labor, and the postpartum period; and

(2) Have a minimum floor area of one hundred and sixty square feet. The length or width of the room shall have a minimum dimension of eleven feet. The vestibule, toilet and bathing areas and closets will not be considered in determining the square footage;

(3) Have doorways and hallways of adequate width and configuration to accommodate maneuvering of ambulance stretchers and beds;

(4) Be located to provide rapid unimpeded access to an exit of the building which shall accommodate emergency transportation vehicles and equipment; and

(5) Have hot and cold running water.

(C) Each freestanding birth center shall provide:

(1) Toilet and bathing facilities including toilet, sink and bath or shower facilities with appropriately placed grab bars for patients. The toilet and bathing facilities shall be shared by not more than two birth rooms;

(2) Toilet and hand washing facilities for families, and personnel;

(3) Space for coats, boots, and umbrellas in inclement weather;

(4) A system of communication between the birth room and other areas of the center that effectively can alert the staff on duty of emergencies or patient needs;

(5) Access to an outside telephone line;

(6) Handrails in halls, stairwells and bathrooms;

(7) Childproof electrical outlets in public areas;

(8) Access to a drinking fountain or potable drinking water with disposable cup dispenser;

(9) A system to provide emergency lighting; and

(10) A separate area for storing clean and sterile supplies.

(D) Each freestanding birth center shall establish and maintain safety guidelines, practices and policies which are reviewed at least once every twelve months to assure a safe environment for patients, families, visitors and staff members. The center shall conduct and maintain records of the following:

(1) Evaluation of the heat, ventilation, emergency lighting, waste disposal, water supply, laundry and kitchen equipment; and

(2) Evaluation of the physical environment for hazards that may cause injury from falls, electrical shock, poisoning and burns. Risk factors of hazards include, but are not limited to, unsafe toys, unprotected stairs and unlocked storage cabinets. The review of the physical environment shall include the exterior of the facility including walkways, parking lots and outside recreation areas.

(E) Freestanding birth centers may provide laundry services on-site or off-site. Centers that provide laundry services on-site shall provide an area for laundry equipment with counter and storage space. The center shall provide for the separate collection, storage, and disposal of soiled materials. Soiled laundry shall be held in the soiled holding area until deposited in the washer.

(F) Sterile supplies may be prepackaged disposables or processed off-site. If the freestanding birth center sterilizes instruments and supplies on-site, an area for accommodation of sterilizing equipments appropriate to the volume of the birth center shall be provided.

(G) Each freestanding birth center shall provide an area for families to store and serve light refreshments. The area shall include a sink and counter space, oven or microwave, refrigerator, cooking utensils, disposable tableware or dishwasher, storage space, and a seating area.

(H) Each freestanding birth center shall provide in each birth room an area for equipment and supplies for newborn care and a separate area for the equipment and supplies for maternal care.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-40 Equipment standards.

(A) Each freestanding birth center shall have a readily accessible and securely stored emergency cart or tray for the newborn, equipped in accordance with national standards of care or guidelines to carry out the written emergency procedures established by the center.

(B) Each freestanding birth center shall have a readily accessible and securely stored emergency cart or tray for the resuscitation of the mother, equipped in accordance with national standards of care or guidelines, to carry out the written emergency procedures of the center.

(C) Each freestanding birth center shall designate an area for the maternal and newborn emergency equipment and supplies that shall be out of the direct line of traffic and immediately accessible to any room in which a birth may occur.

(D) Each freestanding birth center shall develop and implement a preventive maintenance and repair program in accordance with manufacturer's specifications. The center shall maintain records of equipment performance, maintenance and malfunctions for a minimum of three years.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/1996, 9/5/02

3701-83-41 Supplies and medications.

(A) Each freestanding birth center shall maintain an inventory of supplies and medications that is sufficient to care for the number of patients.

(B) Each freestanding birth center shall establish and follow protocols in accordance with standards established by the American college of obstetrics and gynecology for the use of medications during labor or at the time of birth.

(C) Each freestanding birth center shall:

(1) Monitor the shelf life of all medications and supplies;

(2) Secure, store or dispose of all disposable supplies such as needles and prescription pads appropriately in accordance with state and federal laws;

(3) Maintain controlled drugs in a double-locked secured cabinet and provide refrigeration for biologicals; and

(4) Establish and follow written policies and procedures for accountability of all medications and supplies.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-42 Quality assessment and performance improvement.

(A) As part of the quality assessment and performance improvement program required under rule 3701-83-12 of the Administrative Code, each freestanding birth center shall evaluate the provision of direct care services for the mother and newborn. The evaluation of direct care services shall include:

(1) Development and evaluation of risk criteria for determining eligibility for admission to and continuation in the birth center program of care;

(2) Documentation and review of complications and adverse events which arose during the provision of the center's services including complications of pregnancy, labor and postpartum;

(3) Review and evaluation of the management of care;

(4) Evaluation of the appropriateness of diagnostic and screening procedures including laboratory studies, sonography, and non-stress tests;

(5) Evaluation of the appropriateness of medications prescribed, dispensed or administered in the birth center;

(6) Review of all transfers of mothers and neonates to a hospital or other health care setting or provider to determine the appropriateness and quality of the transfer;

(7) Development of discharge criteria for the mother and the newborn;

(8) Regular review of medical records including review for legibility and completeness;

(9) Annual review of protocols, policies and procedures relating to maternal and newborn care;

(10) Review of the maternal and newborn assessment procedures as they impact on quality of care and cost to the patient;

(11) Review of the provision of emergency services including services listed in paragraph (C) of rule 3701-83-34 of the Administrative Code; and

(12) Evaluation of the center's compliance with local, state and federal requirements and national standards of care related to the provision of care.

(B) As part of the quality assessment and performance improvement program required under paragraph (A) of rule 3701-83-12 of the Administrative Code, each freestanding birth center shall report to the director:

(1) The total number of women who delivered;

(2) The total number of live births by weight, in grams;

(3) The total number of fetal deaths;

(4) The total number of neonatal deaths;

(5) The total number of maternal deaths;

(6) The total number of emergency cesarean-sections performed including:

(a) The total number of primary cesarean-sections, and

(b) The total number of repeat cesarean-section;

(7) The total number of attempted vaginal births after a previous cesarean-section and the total number of successful vaginal births after a cesarean-section;

(8) The total number of newborns whose estimated gestational age is less than thirty-seven weeks, and the total number of newborns whose estimated gestational age is greater than forty-two weeks;

(9) The total number of maternal transfers to an obstetric and newborn care services including;

(a) The total number of transfers prior to delivery, and

(b) The total number of transfers after delivery;

(10) The total number of patients seeking admission and the total number of patients admitted.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3702.30
Prior Effective Dates: 1/13/96, 6/27/96, 9/5/02

3701-83-43 Definitions - freestanding radiation therapy centers.

As used in rules 3701-83-43 to 3701-83-50 of the Administrative Code:

(A) "Authorized user" means a physician who meets the definition in rule 3701:1-58-01 of the Administrative Code and is listed as the authorized user on the radioactive materials license issued by the director to the freestanding radiation therapy center.

(B) "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(C) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in rule 3701:1-38-01 of the Administrative Code.

(D) "Freestanding radiation therapy center" means a facility, part of a facility, or any arrangement in which radiation therapy services are transported to various sites, at which radiation therapy is provided to patients. "Freestanding radiation therapy center" does not include the provision of radiation therapy by a hospital registered under section 3701.07 of the Revised Code, or the provision of radiation therapy by an entity that is reviewed as part of a hospital accreditation or certification program.

(E) "Interstitial application" means the use of sealed radioactive sources within special applicators placed in tissue in a predetermined pattern.

(F) "Intracavitary application" means the use of radioactive sources in closed containers placed in body cavities.

(G) "Intraluminal" means within the lumen of a tube or tubular organ, such as a blood vessel.

(H) "Ionizing radiation" means gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other atomic or nuclear particles or rays.

(I) "Nuclear medicine physician" means a physician listed as an authorized user on a radioactive materials license issued by the director for that modality as required in Chapter 3701:1-58 of the Administrative Code.

(J) "Radiation oncologist" means a physician who has satisfactorily completed a radiation oncology residency in an accreditation council for graduate medical education or American osteopathic association approved program; and is certified by one of the following:

(1) The American board of radiology or the American osteopathic board of radiology" and who has a practice limited to radiation oncology;

(2) The American board of radiology, the American osteopathic board of radiology, or the royal college of physicians and surgeons of Canada in radiation oncology or therapeutic radiology; or

(3) The American board of certification in radiology in radiation oncology.

(K) "Radiologist" means a physician board certified in radiology by the American board of radiology, the American oteopathic board of radiology, or by the royal college of physicians and surgeons of Canada", or who has completed a formal accreditation council for graduate medical education (ACGME) or American osteopathic association approved residency in radiology.

(L) "Radiation therapy" means the use of ionizing radiation or radiopharmaceuticals for therapy, including external beam radiation therapy (teletherapy), intraoperative radiation therapy, brachytherapy, and radioactive materials for therapeutic administration as authorized on a radioactive materials license issued by the director pursuant to rules 3701:1-58-43 and 3701:1-58-55 of the Administrative Code in the treatment of human illness.

(M) "Simulation" means the mock-up of a patient treatment with radiographic documentation of the treatment portals.

(N) A "teletherapy physicist" means a physicist who meets the definition in rule 3701:1-58-01 of the Administrative Code and the training criteria specified in rule 3701:1-58-71 of the Administrative Code.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 7/26/01, 6/1/06

3701-83-44 General service standards.

(A) Each freestanding radiation therapy center shall evaluate the patient and assess tumors.

(1) The evaluation shall be conducted by the radiation oncologist and shall include a medical history, a physical examination, a review of the patient's diagnostic studies and reports, and, when appropriate, consultation by the radiation oncologist with the referring physician.

(2) The assessment of tumors shall include a definition of tumor location, and the extent and stage of the tumor.

(B) Each freestanding radiation therapy center shall provide services necessary to meet the needs of the patient including:

(1) Consultation;

(2) Treatment planning, including the selection of dose, selection of treatment modality, and selection of treatment technique;

(3) Determination of optimal treatment program and calculation of dose;

(4) Simulation of treatment; and

(5) Clinical treatment management and patient education.

(C) Each freestanding radiation therapy center shall establish policies and implement procedures for the follow-up of patients who are treated with curative intent and patients who are treated with palliative intent by the radiation oncologist.

(1) The radiation oncologist shall establish a post-treatment follow-up plan for each patient.

(2) Each center shall establish policies and procedures to provide for the long term follow-up of patients treated with curative intent. The follow-up of patients treated with curative intent shall be for a five year period whenever feasible or practical. The follow-up shall include documentation of the outcome of therapy including the results of treatment such as tumor control or survival, and significant sequelae.

If the center is unable to conduct the follow-up as planned, the center shall document the reason in the patient's medical record.

(D) Radiation therapy shall be provided only upon written order of a radiation oncologist. Each freestanding radiation therapy center shall communicate with referring physicians regarding the radiation therapy.

(E) Each freestanding radiation therapy center shall comply with the requirements pertaining to the Ohio cancer incidence surveillance system established under sections 3701.261 to 3701.263 of the Revised Code and Chapter 3701-4 of the Administrative Code.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-45 Personnel requirements and qualifications - freestanding radiation therapy centers.

(A) Each freestanding radiation therapy center shall have an administrator.

(B) Each freestanding radiation therapy center shall have a radiation oncologist, nuclear medicine physician, radiologist, or other authorized user, who meets the qualifications of paragraph (I), (J), or (K) of rule 3701-83-43 of the Administrative Code or rule 3701:1-58-40 , 3701:1-58-51 or 3701:1-58-54 of the Administrative Code, as medical director. The medical director, radiation oncologists, radiologists, nuclear medicine physicians, and authorized users shall be qualified by training, experience, and certification to perform the scope of radiation therapy services provided by the facility. The medical director shall:

(1) Approve specific duties that may be performed by each member of the physics staff as established by the medical physicist under paragraph (E) of this rule;

(2) Ensure appropriate coverage of the radiation therapy center by radiation oncologists or other authorized users and staff.

(C) A radiation oncologist, nuclear medicine physician, radiologist, or other authorized user shall be available for direct care and quality review on a daily basis. If the radiation oncologist, nuclear medicine physician, radiologist, or other authorized user is not on-site, the radiation oncologist, nuclear medicine physician, radiologist, or other authorized user shall be accessible by phone, beeper, or other designated mechanism.

(D) Each radiation therapy center shall have a medical physicist or teletherapy physicist who:

(1) Is certified by the American board of radiology in radiological physics or therapeutic radiological physics;

(2) Is certified by the American board of medical physics in medical physics with a specialty in radiation oncology physics;

(3) Has a master's degree or doctorate from an accredited college or university in physics, biophysics, medical physics, radiological physics, nuclear engineering or health physics, and three years of experience in radiation therapy to include performance evaluations, safety checks, and treatment planning ; or

(4) Is currently certified by the Ohio department of health as a certified radiation expert in the category of therapeutic and meets the requirements of paragraph (C)(3) of rule 3701:1-66-03 of the Administrative Code.

(E) The medical physicist or teletherapy physicist shall be available for consultation with the radiation oncologist, nuclear medicine physician, radiologist, or other authorized user to provide advice or direction to staff when patient treatments are being planned or patients are being treated. Radiation therapy centers shall have regular on-site physics support during hours of clinical activity. The on-site support shall, at a minimum, be provided on a weekly basis. When a medical physicist or teletherapy physicist is not available on-site, other physics duties shall be established and documented in writing by the medical physicist or teletherapy physicist. The medical physicist shall specify the specific physics duties that shall be performed by each member of the physics staff in accordance with their qualification and competence.

(F) Each freestanding radiation therapy center shall have available a sufficient number of qualified staff for the radiation therapy services provided including individuals licensed as radiation therapy technologists or nuclear medicine technologists under Chapter 4773. of the Revised Code, who are able to supervise and conduct the radiation therapy services as appropriate for the services being offered. The nuclear medicine physician, radiologist, radiation oncologist, or other authorized user and support staff shall be available to initiate urgent treatment with a medically appropriate response time on a twenty-four hour basis.

(G) In addition to the requirements of paragraph (B) of rule 3701-83-08 of the Administrative Code, each freestanding radiation therapy center shall establish personnel files for all individuals who provide radiation therapy services and shall:

(1) Maintain files for each individual which specify the types of procedures or services the individual is permitted to perform; and

(2) Update all files at least every twelve months.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 7/26/01, 6/1/06

3701-83-46 Treatment standards.

(A) The radiation oncologist shall establish the doses desired throughout the tumor and set dose limits to critical structures. Treatment deliveries shall meet the specifications of the radiation oncologist.

(B) All treatment applications shall be described in detail and signed by the radiation oncologist. The radiation oncologist shall be notified of any changes that may be necessary in the planned schedule of treatment.

(C) Each freestanding radiation therapy center shall:

(1) Provide or arrange for appropriate radiation treatment localization, simulation and verification;

(2) Provide or arrange for isodose treatment planning with complex analyses generated in appropriate cases;

(3) Provide accurate calculation of doses and dose distribution;

(4) Provide a system for independent checking of initial dose calculations. The check shall be conducted before the third fraction, or before twenty percent of the total dose when the treatment schedule provides less than ten fractions. The independent check includes utilizing another individual or method approved and documented by the medical physicist to verify dose calculations.

(5) Conduct ongoing reviews of accumulating doses;

(6) Conduct a chart and port film review weekly;

(7) Accurately chart treatment doses; and

(8) Maintain records of all data used in planning the specific treatment for a patient in the patient's medical record.

(D) Each freestanding radiation therapy center shall provide devices to aid in positioning and immobilizing the patient. Normal tissue shields, compensating filters, wedges and other aids shall be provided as medically appropriate.

(E) Initial port films shall be reviewed by the radiation oncologist prior to the second treatment and the port films shall be reviewed at least every ten treatments.

(F) Each freestanding radiation therapy center shall establish and maintain procedures for handling medical emergency cardiac care.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 9/1/03

3701-83-47 Radiation safety standards - freestanding radiation therapy centers.

(A) Each freestanding radiation therapy center shall maintain and follow written policies and procedures for the handling of emergencies which may threaten the health and safety of patients, staff and public.

(B) Each freestanding radiation therapy center shall comply with the applicable provisions of Chapter 3748. of the Revised Code and the rules adopted pursuant to that chapter.

(C) Each freestanding radiation therapy center shall identify, document, and report to the department:

(1) Misadministrations in accordance with rule 3701:1-67-12 of the Administrative Code; or .

(2) Medical events in accordance with rule 3701:1-58-101 of the Administrative Code.

Replaces: 3701-83-47

Effective: 01/14/2011
R.C. 119.032 review dates: 01/14/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13 , 3702.30
Rule Amplifies: 3702.12 , 3702.13 , 3748.30
Prior Effective Dates: 1/13/1996, 9/5/02, 6/1/06

3701-83-48 Equipment standards.

(A) Each freestanding radiation therapy center shall have the necessary equipment to provide services with accuracy, precision, and efficiency.

(1) Each center shall provide, either on-site or by referral, for diagnostic services including computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, nuclear medicine, and clinical and surgical pathology.

(2) Each freestanding radiation therapy center shall document arrangements for referrals to one or more other radiation therapy sites so that the patients will have access to a broad spectrum of radiation therapy equipment and a variety of treatment modalities including at least brachytherapy and a unit of radiation therapy equipment providing photons of at least ten megavolts (MV) and electron energies to at least twelve megaelectron volts (MeV).

(B) Each freestanding radiation therapy center shall develop and implement a program to monitor the calibration and measurement of radiation beam characteristics to assure accurate and reliable delivery of ionizing radiations. Calibration and operation of radiation therapy equipment shall be in accordance with the radiation requirements specified in rules 3701:1-66-14 and 3701:1-66-15 of the Administrative Code.

(C) Each freestanding radiation therapy center shall develop and implement a preventive maintenance and repair program for equipment in accordance with manufacturer's specifications. The center shall maintain records of equipment performance, maintenance and malfunctions.

(D) Each freestanding radiation therapy center that operates a linear accelerator, cobalt radiation therapy unit, or gamma knife shall comply with the applicable provisions of section 3702.11 of the Revised Code and the rules adopted pursuant to that section.

(E) Each freestanding radiation therapy center shall maintain emergency equipment and medications appropriate for the services provided.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 9/1/03

3701-83-49 Medical record.

In addition to the requirements of rule 3701-83-11 of the Administrative Code, each freestanding radiation therapy center shall maintain documentation of the following in the patient's medical record:

(A) Confirmation of the presence of malignancy by histopathology, or a statement of benign condition, or other alternative evidence for diagnosis of all cases accepted for radiation;

(B) Documentation of services and radiographic images, including localization films, appropriate to the therapy provided;

(C) Report of the initial evaluation including a definition of the tumor location, and the extent of each cancer as a basis for staging;

(D) The treatment plan including the selection of dose, selection of treatment modality, and selection of treatment technique;

(E) The dosimetry calculations;

(F) The patient's progress and tolerance; and

(G) The completion of treatment with statement of follow-up plan.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-50 Quality assessment and performance improvement program.

(A) As part of the quality assessment and performance improvement program required under paragraph (A) of rule 3701-83-12 of the Administrative Code, each freestanding radiation therapy center shall report to the director:

(1) The number and type of radiation therapy equipment utilized; and

(2) The type of radiation therapy services provided.

(B) As part of the quality assessment and performance improvement program requirements under paragraph (C) of rule 3701-83-12 of the Administrative Code, each freestanding radiation therapy center shall evaluate the provision of radiation therapy services including a review of case management and treatment results and a review of complications and adverse events which occurred during the provision of the center's services.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12 , 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996

3701-83-51 Definitions - freestanding diagnostic imaging centers.

As used in rules 3701-83-51 to 3701-83-55 of the Administrative Code:

(A) "Authorized user" means a physician who meets the definition of authorized user in rule 3701:1-58-01 of the Administrative Code for the specified modality.

(B) "Chiropractic radiologist" means a chiropractor with:

(1) Diplomat status by the American chiropractic board of radiology; and

(2) CT and MRI credentialing by the American chiropractic board of radiology.

(C) "Computed tomography" or "CT" means the production of a tomogram by the acquisition and computer processing of X-ray transmission data.

(D) "Diagnostic imaging" means the production of images used for medical diagnosis using:

(1) MRI;

(2) PET;

(3) CT;

(4) Nuclear medicine as authorized on a radioactive materials license issued by the director pursuant to rule 3701:1-58-32 , 3701:1-58-34 , 3701:1-58-37 or 3701:1-58-53 of the Administrative Code; and

(5) Fluoroscopy.

"Diagnostic imaging" does not mean the production of images used for medical diagnosis using diagnostic x-ray, mammography, or ultrasound.

(E) "Diagnostic x-ray" means the irradiation of any part of the human body for the purpose of diagnosis or visualization.

(F) "Freestanding diagnostic imaging center" means a facility, or part of a facility, at which diagnostic imaging services are provided. A freestanding diagnostic imaging center does not include the provision of diagnostic imaging by a hospital registered under section 3701.07 of the Revised Code, or the provision of diagnostic imaging by an entity that is reviewed as part of a hospital accreditation or certification program.

(G) "Fluoroscopy" means the use of a fluorescent screen suitably mounted, either separately or in conjunction with a roentgen tube for visualizing and imaging internal structures which uses the injection or ingestion of contrast media for medical diagnosis.

(H) "Magnetic resonance imaging" or "MRI" means the use of an integrated set of machines utilizing radio frequency and magnetic fields to produce images of organs and tissue or spectroscopic quantitative data.

(I) "Mammography" means radiography of the breast.

(J) "Mobile diagnostic imaging center" means any arrangement in which diagnostic imaging services are transported to various sites. A mobile diagnostic imaging center does not include movement within a hospital or movement to a site where the equipment will be located permanently and does not include the provision of diagnostic imaging by an entity that is reviewed as part of a hospital accreditation program.

(K) "Nuclear medicine" means the use of internal radiopharmaceuticals for the diagnosis and treatment of patients.

(L) "Positron emission tomography" or "PET" means a nuclear medicine imaging technique employing a radiotracer radiopharmaceutical with a positron emitting radionuclide to provide functional information such as on blood flow or metabolism.

(M) "Radiologist" means a physician board certified in radiology by the American board of radiology, the American osteopathic board of radiology, or by the royal college of physicians and surgeons of Canada, or who has completed a formal accreditation council for graduate medical education (ACGME) or American osteopathic association approved residency in radiology.

(N) "Nuclear medicine physician" means a physician listed as an authorized user on a radioactive materials license issued by the director for that modality as required in Chapter 3701:1-58 of the Administrative Code.

(O) "Ultrasound" means a diagnostic imaging technique which employs high frequency low energy sound waves for imaging and doppler examinations.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/96, 6/27/96, 7/26/01, 7/1/06

3701-83-52 Personnel and staffing requirements - freestanding diagnostic imaging centers.

(A) Each freestanding or mobile diagnostic imaging center shall have a radiologist, nuclear medicine physician, authorized user, physician acting within their scope of practice, or chiropractic radiologist, as appropriate to the diagnostic imaging services being offered, that has overall responsibility for the diagnostic imaging services being provided by the freestanding or mobile diagnostic imaging center.

(B) Each freestanding or mobile diagnostic imaging center shall have a physician on site when sedation or contrast agents are being administered.

(C) CT freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) CT services shall be provided only upon the written order of a physician, chiropractor, dentist or podiatrist;

(2) CT image interpretation shall be conducted by:

(a) A radiologist; or

(b) A physician or chiropractic radiologist acting within his or her scope of practice who does not meet the requirements of paragraph (N) of rule 3701-83-51 of the Administrative Code who has at least two years cross-sectional imaging and interpretation experience.

(3) A medical physicist with one of the following:

(a) Certification by the American board of radiology in radiological physics or diagnostic radiological physics;

(b) Certification by the American board of medical physics in medical physics with a specialty in diagnostic imaging physics;

(c) Master's degree or doctorate from an accredited college or university in physics, biophysics, medical physics, radiological physics or health physics, or mechanical, electrical or nuclear engineering, or applied mathematics with a minor in physics and three years of experience in evaluating diagnostic radiation-generating equipment and quality assessment and improvement programs; or

(d) Current certification by the Ohio department of health as a certified radiation expert in the category of diagnostic other than mammography as specified in paragraph (D) of rule 3701:1-66-03 of the Administrative Code.

(4) An individual licensed under Chapter 4773. of the Revised Code as a radiographer.

(D) MRI freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) MRI services shall be provided only upon the written order of a physician, chiropractor, dentist or podiatrist;

(2) MRI image interpretation shall be conducted by:

(a) A radiologist; or

(b) A physician or chiropractic radiologist acting within his or her scope of practice who does not meet the requirements of paragraph (N) of rule 3701-83-51 of the Administrative Code who has at least six months experience or training in cross-sectional body imaging and image evaluation and interpretation.

(3) A service and preventive maintenance program shall be established by the health care facility to monitor and maintain, in accordance with the manufacturer's specifications, the equipment management program as required by rule 3701-83-53 of the Administrative Code, and the quality assessment andperformance improvement program as required by rules 3701-83-12 and 3701-83-55 of the Administrative Code.

(4) A technologist for preparing and positioning the patient and for obtaining the MRI data in a manner suitable for interpretation. As used in this paragraph, "technologist" means an individual registered with the American registry of radiologic technologists in the categories of "radiography", "nuclear medicine technology", "radiation therapy technology" or "magnetic resonance imaging"; certified by the American registry of magnetic resonance imaging technologists; or registered as a nuclear medicine technologist with the nuclear medicine technology certification board.

(E) PET and nuclear medicine freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) PET and nuclear medicine services shall be provided only upon the written order of an authorized user pursuant to rule 3701:1-58 of the Administrative Code;

(2) PET and nuclear medicine image interpretation shall be conducted by one of the following:

(a) A nuclear medicine physician;

(b) A radiologist;

(c) A physician acting within his or her scope of practice who meets the requirements of rule 3701:1-58-36 of the Administrative Code.

(d) A physician acting within his or her scope of practice who does not meet the requirements of paragraph (M) or (N) of rule 3701-83-51 of the Administrative Code that is supervised by a physician who is qualified pursuant to paragraph (E)(2)(a), (E)(2)(b), or (E)(2)(c) of this rule while the physician is completing a training program that will result in certification as a physician listed in paragraph (E)(2)(a), (E)(2)(b), or (E)(2)(c) of this rule.

(3) An individual licensed under Chapter 4773. of the Revised Code as a nuclear medicine technologist; and

(4) A radiation safety officer who meets the requirements of rule 3701:1-58-18 of the Administrative Code and is listed on the Ohio radioactive materials license.

(F) Fluoroscopy freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) Fluoroscopy services shall only be provided upon the written order of a physician, dentist, or chiropractor;

(2) Fluoroscopy image interpretation shall be conducted by one of the following:

(a) A radiologist;

(b) A physician or chiropractic radiologist acting within his or her scope of practice who does not meet the requirements of paragraph (N) of rule 3701-83-51 of the Administrative Code who has at least six months experience or training in the performance and interpretation of fluoroscopy; or

(3) A medical physicist with one of the following:

(a) Certification by the American board of radiology in radiological physics or diagnostic radiological physics;

(b) Certification by the American board of medical physics in medical physics with a specialty in diagnostic imaging physics;

(c) Master's degree or doctorate from an accredited college or university in physics, biophysics, medical physics, radiological physics or health physics, or mechanical, electrical or nuclear engineering, or applied mathematics with a minor in physics and three years of experience in evaluating diagnostic radiation-generating equipment and quality assessment and improvement programs; or

(d) Current certification by the Ohio department of health as a certified radiation expert in the category of diagnostic other than mammography as specified in paragraph (D) of rule 3701:1-66-03 of the Administrative Code.

(4) An individual licensed under Chapter 4773. of the Revised Code as a radiographer.

(G) In addition to the requirements of paragraph (B) of rule 3701-83-08 of the Administrative Code each freestanding or mobile diagnostic imaging center shall establish personnel files for all individuals who provide diagnostic imaging services and shall:

(1) Maintain files for each individual which specify the types of procedures the individual is permitted to perform; and

(2) At least every twelve months update all files.

(H) For CT and fluoroscopy services, the individual qualified under the requirements of paragraphs (C)(3) and (F)(3) of this rule shall be available for consultation with the radiologist or authorized user responsible for diagnostic imaging services to provide advice and direction, and the availability of the medical physicist shall be documented in writing and shall include:

(1) Conducting an on-site survey at least annually of the imaging equipment in accordance with the manufacturer's specifications to evaluate compliance with applicable rules adopted pursuant to Chapter 3748. of the Revised Code, the equipment management program as required by rule 3701-83-53 of the Administrative Code, and the quality assessment and improvement program as required by rules 3701-83-12 and 3701-83-55 of the Administrative Code; and

(2) Establishing written procedures to specify physics duties that shall be performed by each member of the physics staff in accordance with their qualifications and competance, and with the approval of the radiologist or authorized user responsible for diagnostic imaging services, as applicable to the services provided.

(I) For MRI services, an individual shall be available for consultation with the individual specified in paragraph (A) of this rule to provide advice and direction, and the availability of the individual shall be documented in writing and shall include:

(1) Conducting an on-site survey at least annually to evaluate the equipment management program as required by rule 3701-83-53 of the Administrative Code; and

(2) Establishing written procedures to specify service and preventive maintenance duties that shall be performed by each member of the staff in accordance with their qualifications and competence that are approved by the individual specified in paragraph (A) of this rule.

(J) For PET and nuclear medicine services, the individual qualified under the requirements of paragraph (E)(4) of this rule shall implement and conduct the activities specified in rules 3701:1-58-38 , 3701:1:58-40, 3701:1-58-50 and 3701:1-58-58 of the Administrative Code.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13
Rule Amplifies: 3701.12 , 3702.30
Prior Effective Dates: 1/13/1996, 6/27/96, 7/26/01, 7/1/06

3701-83-53 Service standards and equipment.

(A) Each freestanding or mobile diagnostic imaging center shall have equipment necessary to provide services with accuracy, precision, and efficiency as evidenced by:

(1) All diagnostic imaging equipment shall be certified for clinical use by the United States food and drug administration;

(2) All diagnostic imaging equipment specifications and performance shall meet all applicable state and federal requirements; and

(3) The development and maintenance of an equipment management program which shall at a minimum:

(a) Maintain a current inventory of all diagnostic imaging equipment utilized by the freestanding or mobile diagnostic imaging center;

(b) Maintain and identify the clinical applications, maintenance requirements, and equipment malfunction history of all diagnostic imaging equipment utilized by the freestanding or mobile diagnostic imaging center;

(c) Assess the clinical and physical risks of all fixed and mobile equipment utilized in the provision of diagnostic imaging services;

(d) Develop and implement procedures for the regular maintenance and testing of equipment in accordance with manufacturer's guidelines; and

(e) Provide appropriate equipment orientation and training programs for personnel who use or maintain the freestanding or mobile diagnostic imaging center's equipment.

(B) Each freestanding or mobile diagnostic imaging center shall identify, document, and report to the department incidents in which equipment utilized by the diagnostic imaging center contributed or may have contributed to patient injury, illness, or death.

(C) Each freestanding or mobile diagnostic imaging center shall establish and maintain safety guidelines, and practices and policies in accordance with applicable United States nuclear regulatory commission regulations and the applicable provision of Chapter 3748. of the Revised Code and the rules adopted pursuant to that chapter to assure a safe environment for patients, visitors, and personnel.

(D) Safety factors established and maintained by each freestanding or mobile diagnostic imaging center shall also include:

(1) Precautions against electrical and mechanical hazards;

(2) Precautions against the potential interactions of the magnetic field with ferromagnetic objects.

(E) Each freestanding or mobile diagnostic imaging center shall establish and maintain procedures for handling medical emergencies including emergency cardiac care. Each site at which diagnostic imaging services are provided shall have the equipment, supplies, and personnel necessary to handle clinical emergencies that might occur, including adverse reactions to contrast agents.

(F) Each freestanding or mobile diagnostic imaging center shall have a staff member current in basic life support on duty at the center when patients are there.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 6/27/96

3701-83-54 Medical records requirements.

(A) In addition to the requirements of rule 3701-83-11 of the Administrative Code, each freestanding or mobile diagnostic imaging center shall maintain a diagnostic imaging radiology report which includes the following:

(1) Patient name or identifier;

(2) Name of referring physician, podiatrist, dentist, or chiropractor;

(3) Name of physician or chiropractic radiologist conducting image interpretation;

(4) Name and type of diagnostic image performed and any contrast media used;

(5) Date of image;

(6) Findings;

(7) Factors limiting interpretability of exam;

(8) Pertinent clinical issues; and

(9) Conclusion or diagnosis.

(B) Each freestanding or mobile diagnostic imaging center shall maintain all medical records for a period of six years from the date of service.

(C) A mobile diagnostic imaging center may, by contract with a facility being served, require the facility to maintain such reports and medical records, provided that such reports and medical records are made available to the department for purposes of section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.12
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 6/27/96

3701-83-55 Quality assessment and performance improvement - freestanding diagnostic imaging centers.

(A) As part of the quality assessment and performance improvement program required under paragraph (C) of rule 3701-83-12 of the Administrative Code, each freestanding or mobile diagnostic imaging center shall:

(1) Establish and maintain a clinical image quality control program to monitor and document images repeated due to poor image quality;

(2) Monitor and evaluate the accuracy of image interpretations by establishing a clinical image review program. The center shall establish policies and procedures for and provide for the semiannual audit of a random, representative sample of total clinical images performed at the center. The audit shall be conducted by a radiologist or by a physician or chiropractor as identified under paragraphs (C)(2), (D)(2), (E)(2), and (F)(2) of rule 3701-83-52 of the Administrative Code. Diagnostic imaging centers under the operation of more than one physician or chiropractic radiologist may conduct their own internal semiannual audit of a random sample of clinical images. Diagnostic imaging centers operated by a single physician or chiropractic radiologist shall provide for the external semiannual audit of a random sample of clinical images. External audits shall not be conducted by an individual who is associated with, or has a financial interest in the center; and

(3) Monitor and evaluate any problems associated with sedation, the administration of contrast agents, and the semiannual audit of a random sample of clinical images.

(B) As part of the quality assessment and performance improvement program required under paragraph (A) of rule 3701-83-12 of the Administrative Code, each freestanding or mobile diagnostic imaging center shall report to the director:

(1) The number, type, and age, of diagnostic imaging equipment, including magnetic strength when applicable, and whether diagnostic imaging equipment is fixed or mobile;

(2) If diagnostic imaging equipment is mobile, a list of the locations where the service is delivered, including contracted sites for which the service is currently not operational;

(3) The number of procedures performed by CPT code;

(4) The number of repeat procedures taken which were conducted in order to obtain a sufficient image relating to the patient's image order;

(5) The number and type of complications associated with sedation and the administration of contrast agents;

(6) The number of patients who required hospitalization, as a result of a complication, within twenty-four hours of a procedure;

(7) The number of diagnostic procedures performed and the number that revealed negative findings; and

(8) The number of clinical images audited by the center or an external individual, and the number of cases in which there was variance between audited findings and original findings.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.13
Rule Amplifies: 3702.30
Prior Effective Dates: 1/13/1996, 6/27/96, 6/1/06

3701-83-56 Definitions - exempt freestanding birthing centers.

As used in rules 3701-83-56 to 3701-83-59 of the Administrative Code:

(A) "Apprentice midwife" means an individual who is currently serving an apprenticeship under a practicing midwife.

(B) "Certified professional midwife" means an independent practitioner who has met the standards for certification set by the North American registry of midwives.

(C) "Certified nurse-midwife" or "CNM" has the same meaning as in paragraph (A) of rule 3701-83-33 of the Administrative Code.

(D) "Director of patient services" means the individual who is responsible for managing and directing the provision of patient services at the exempt center. The director of patient services may serve as the administrator of the exempt center.

(E) "Doula" means an assistant who provides various forms of non-medical, non-midwifery and non-clinical physical or emotional support during the pre-natal, childbirth, and postpartum periods.

(F) "Exempt freestanding birthing center," "exempt freestanding birth center," "exempt birth center," or "exempt center" means a health care facility that is not required to obtain a license under section 3702.30 of the Revised Code and paragraph (B) of rule 3701-83-03 of the Administrative Code.

(G) "Lay midwife" or "traditional midwife" means an individual who has entered the profession as an apprentice to a practicing midwife rather than a formal school or certification program.

(H) "Low-risk pregnancy" means an expectant mother that does not exhibit evidence of:

(1) Diabetes mellitus or gestational diabetes that is not controlled by diet;

(2) Heart disease in which there is any limitation of physical activity and ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain;

(3) Renal disease;

(4) Endrocrine disorder, except treated by hypothyroidism;

(5) Hematologic disorder;

(6) Severe anemia (hemoglobin less than ten grams per deciliter);

(7) Chronic or gestational hypertension or pre-eclampsia;

(8) RH factor sensitization or other isoimmunization;

(9) Respiratory disease with significant chance of fetal hypoxia or maternal respiratory distress;

(10) Active herpes;

(11) Prior uterine incisions other than low transverse uterine incisions;

(12) Prematurity as defined as less than thirty-seven weeks gestation;

(13) Human immunodeficiency virus positive;

(14) Known congenital anomalies except for anomalies that do not require services beyond the extent of services the center is authorized by law to provide;

(15) Previous abruption;

(16) Known or suspected drug or alcohol use;

(17) Suspected or documented intrauterine growth retardation or fetal macrosomia;

(18) Placental abnormalities;

(19) Expectation of multiple births;

(20) Non-vertex presentation; and

(21) Deep venous thrombophlebitis.

(I) "Low-risk delivery" means the delivery by a woman not exhibiting evidence of:

(1) Previous low transverse cesarean birth;

(2) Previous postpartum hemorrhage requiring treatment by transfusion;

(3) Epilepsy or seizures controlled by medication;

(4) Previous postmaturity delivery as defined as greater than forty-two weeks gestation;

(5) A lack of prenatal care;

(6) Cephalopelvic disproportion; or

(7) Other serious or acute medical conditions.

(J) "Medical director" means the physician the exempt center has appointed to provide medical consultation and direction regarding the operations of the center.

(K) "Midwife" means a certified professional midwife, a lay midwife, or a traditional midwife.

(L) "Patient" means an expectant mother, mother, or newborn.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.301
Rule Amplifies: 3702.301
Prior Effective Dates: 6/1/2007

3701-83-57 Patient safety monitoring and evaluation - exempt freestanding birthing centers.

(A) Each exempt freestanding birthing center shall admit, retain, discharge and transfer patients in accordance with the requirements of this rule to assure the safety of its patients.

(1) Exempt centers may admit, retain, and provide care exclusively to women members of the religious denomination, sect, or group that owns and operates the center who anticipate a low-risk pregnancy, low-risk delivery and normal full-term spontaneous vaginal birth, and to their newborns.

(2) Prior to admission, each expectant mother shall be assessed by a physician, CNM, or midwife as defined in paragraph (K) of rule 3701-83-56 of the Administrative Code to determine whether she is a low-risk pregnancy and whether a low-risk and full-term, spontaneous vaginal delivery is anticipated.

(a) Exempt centers shall consult with a physician before admitting or retaining an expectant mother exhibiting signs of having other than a low-risk pregnancy or low-risk and full-term spontaneous vaginal delivery, or an expectant mother who has had no prenatal care.

(b) If the consulting physician determines that the expectant mother may not have a low risk pregnancy or low risk and full-term spontaneous vaginal delivery, the exempt center shall not admit or retain the expectant mother.

(c) If the expectant mother presents at the exempt center in actual labor or showing impending labor, and has had no prenatal care, the expectant mother must be transferred to a hospital or other health care facility or evaluated by a physician prior to admission to the exempt center.

(3) Each exempt center shall have in place an arrangement with a hospital or other appropriate health care setting or provider for the transfer of a mother or newborn in the event of medical complications, emergency situations or as need arises.

(4) Except as set forth in paragraph (A)(5) of this rule, each exempt center shall transfer the patient to a hospital or other approved health care setting or provider that can meet the needs of the patient if medical intervention or non-routine technology is necessary. Medical intervention or non-routine technology includes:

(a) Anesthetics other than local anesthetics or pudendal block;

(b) Pharmacological augmentation of labor; or

(c) Forceps or vacuum extraction.

(5) An exempt center is not required to transfer a patient requiring medical intervention or non-routine technology if the medical intervention or non-routine technology can be safely and effectively performed by the physician who attends the birth and the attending physician remains with the patient throughout active labor and the immediate postpartum period.

(B) Each exempt freestanding birthing center shall periodically evaluate each patient's health and safety in accordance with the following standards:

(1) The exempt center shall, upon admission of a patient:

(a) Review the patient's health history and prenatal care records;

(b) Observe and document vital signs;

(c) Observe and document labor progress;

(d) Consult with a physician when possible or evident risk for delivery is detected; and

(e) Determine whether further diagnostic or screening procedures at an appropriate health care facility are advisable.

(2) Each exempt center shall evaluate the expectant mother to determine whether an intrapartum transfer to a hospital or other appropriate health care setting is necessary. The evaluation shall include an assessment for the following:

(a) Abnormal progress of labor;

(b) Development of maternal complications;

(c) Probable need for cesarean birth; and

(d) Development of fetal complications.

(3) Each exempt center shall, in consultation with a physician, evaluate the mother and newborn to determine whether a postpartum transfer to a hospital or other appropriate health care setting is necessary including evaluation for the following:

(a) Medical complications of the mother; and

(b) Medical complications of the newborn.

(C) Each exempt center shall monitor the provision of services to ensure they are provided in a safe, considerate and timely manner that meets the needs of the exempt center's patients. Each exempt center shall:

(1) Arrange for and consult with a physician or certified nurse midwife to perform the following activities:

(a) Periodically review the exempt center's patient care policies and procedures and recommend revisions as may be indicated;

(b) Oversee the quality of patient care through periodic review of patient care records;

(c) Periodically review the exempt center's quality and patient safety data; and

(d) Provide consultation to the exempt center regarding admissions, retentions, transfers and discharges of patients.

(2) Practice infection control including observation of all accepted standard precautions and hand washing for staff, patients, and families.

(3) Provide for the separate storage, security, and disposal of hazardous waste.

(4) Ensure that no mother in active labor is left unattended and that a midwife, physician, or CNM attends each birth. A doula of the mother's choosing may attend the mother in active labor, but shall be limited to only non-medical, non-midwifery and non-clinical assistance and support.

(5) Timely respond to medical emergencies that may arise in the provision of services to patients.

(6) Provide intrapartum care that requires minimal intervention and technology including:

(a) Fetal auscultation;

(b) Nourishment;

(c) Activities as may be appropriate;

(d) Comfort measures;

(e) Assessment and evaluation of labor; and

(f) Interaction with family and support of the family.

(7) Provide postpartum and newborn care that promotes bonding and meets patients' needs.

(8) Provide the patient or the patient's representative:

(a) Information about recommended immunizations, vaccines, and metabolic screenings for newborns; and

(b) Instructions for post-treatment care and procedures for obtaining emergency care.

(c) If so designated by the mother, the patient's doula may be the representative for the purpose of receiving the information and instructions indicated in the this paragraph.

(9) Maintain sufficient equipment, supplies and medicinals to care for its patients. Each exempt center shall:

(a) Have a readily accessible and securely stored emergency cart or tray equipped to respond to emergency situations involving either the mother or newborn and consistent with the capabilities of the facility staff;

(b) Monitor the shelf life of all medicinals and supplies maintained by the exempt center for use in the care of services to patients;

(c) Maintain equipment in good working order; and

(d) Operate equipment in a safe manner.

(D) Each exempt freestanding birthing center shall establish and maintain a safe and sanitary environment to ensure patient safety. Each exempt center shall:

(1) Provide, maintain, and periodically evaluate the functional condition of the heating, ventilation, emergency lighting, waste disposal and water supply systems, laundry and kitchen equipment, and handrails in hallways and stairwells;

(2) Maintain and evaluate the physical environment for hazards that may cause injury from falls, electrical shock, poisoning and burns. Risk factors of hazards include, but are not limited to, unsafe toys in family areas, unprotected stairs and unlocked storage cabinets. The review of the physical environment shall include the exterior of the facility including walkways, parking areas and outside recreation areas;

(3) Provide and maintain a home-like environment of adequate size and appropriate configuration with sufficient space for furnishings, equipment, and supplies to provide comfortable and safe accommodations for the number of patients and families served and the personnel providing services;

(4) Provide birth rooms that:

(a) Are of adequate size and appropriate configuration to provide for the equipment, staff members, supplies, and emergency procedures required for the physical and emotional care of the mother, family, and the newborn during labor, birth and the postpartum period;

(b) Have doorways and hallways of adequate width and configuration to accommodate maneuvering of ambulance stretchers and beds in emergencies;

(c) Are located to provide rapid unimpeded access to an exit of the building that will accommodate emergency transportation vehicles and equipment; and

(d) Have toilet and bathing facilities including toilet, sink, and bath or shower facilities with hot and cold running water and with appropriately placed grab bars for patients.

(5) Establish and, when necessary, follow procedures for handling of patients in the event of fire or natural disaster or any other emergency situation requiring the evacuation of patients.

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.301
Rule Amplifies: 3702.301
Prior Effective Dates: 6/1/2007

3701-83-58 Quality assessment and performance improvement.

(A) Each exempt center shall monitor and evaluate the provision of direct care services to its patients and shall implement procedures to improve the quality of care and resolve identified problems. The quality assessment shall, at minimum, include:

(1) The review of all transfers of patients to a hospital or other health care setting; and

(2) The review of complications and adverse events during the provision of the exempt center's services.

(B) As part of the quality assessment and performance improvement activities and to assist the director in determining if the exempt center is in compliance with rules 3701-83-57 and 3701-83-58 of the Administrative Code, each exempt freestanding birth center shall report to the director of health, as may be required, but not less frequently than January twentieth of each year, the following information and data in the format and manner prescribed by the director and appendix A to this rule:

(1) The identification of the administrator or director of patient services of the birth center;

(2) The identification of the physician(s) providing obstetrical or pediatric consultation and oversight to the exempt birth center staff, and number of patient care-related contacts initiated by staff;

(3) Staffing of the exempt birth center, including the number of traditional midwives, apprentice midwives, certified professional midwives, and any state-licensed health care professionals;

(4) How and by whom potential patients are being assessed for risk prior to admission;

(5) The total number of patients seeking admission and total number admitted;

(6) The total number of post delivery admissions, the reason for admission, and the length of stay;

(7) The number of deliveries at the exempt birth center;

(8) The number of deliveries by a physician, a certified nurse midwife, a certified professional midwife, an apprentice midwife, or a lay midwife;

(9) Identification of who attended each delivery within the exempt birth center;

(10) The total number of live births by weight in grams;

(11) The total number of newborns where estimated gestational age was less than thirty-seven weeks and the total number of newborns where estimated gestational age was greater than forty-two weeks;

(12) The total number of fetal, neonatal, and maternal deaths;

(13) The total number of maternal transfers to a hospital obstetric service or other health care setting; whether before or following delivery; the reason for transfer; the date of the transfer; and the name of the receiving entity; and

(14) The total number of neonate transfers to a hospital newborn service or other health care setting; the reason for the transfer; the date of the transfer; and the name of the receiving entity;

(C) The data submitted under this rule shall be reviewed by the exempt center's consulting physician prior to submission.

Click to view Appendix

Effective: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.301
Rule Amplifies: 3702.301
Prior Effective Dates: 6/1/2007

3701-83-59 Compliance - exempt freestanding birthing center.

(A) If the director of health determines that an exempt freestanding birthing center is no longer in compliance with divisions (4) and (5) of section 3702.301 of the Revised Code or rules 3701-83-57 and 3701-83-58 of the Administrative Code, the director may order the facility to come into compliance.

(B) In the order, the director may do any or all of the following:

(1) Identify which requirement the exempt center is not in compliance with and what actions the center needs to take to come into compliance;

(2) Require that the exempt center come into compliance within a period specified in the order;

(3) Require that the exempt center provide the director with a written notice within a time period specified in the order that contains all of the following:

(a) An attestation that the center has come into compliance;

(b) The signature of the exempt freestanding birthing center's administrator or medical director and an attestation that the administrator or medical director, whomever signs the notice, is the center's authorized representative;

(c) An attestation that the information contained in the notice and any accompanying documentation are true and accurate;

(d) Any other information or documentation that the director may require to verify that the center has come into compliance; and

(e) If the noncompliance pertains to patient care, an attestation that the information or documentation provided has been reviewed by the medical director or the consulting physician.

(C) If the exempt freestanding birthing center fails to comply with the director's order within the time period specified in the order, the director may issue a second order that requires the center to cease operations until the center obtains a license as a freestanding birthing center under section 3702.30 of the Revised Code.

(D) In determining whether to issue orders under paragraph (C) of this rule, the director may consider any of the following factors:

(1) The danger of serious physical or life-threatening harm existing or having existed to the patient or patients of the center;

(2) The nature, duration, gravity, and extent of the identified condition, situation or practice existing or continuing;

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

(4) The center's history of quality of care data;

(5) The extent and appropriateness of the actions taken by the center to correct the deficient practice or contributing condition; and

(6) Whether the administrator, medical director, or other staff of the center materially misrepresented any information provided to the director.

R.C. 119.032 review dates: 02/10/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.301
Rule Amplifies: 3702.301
Prior Effective Dates: 6/1/2007