Administrative Code

Virginia Administrative Code
1/30/2023

Article 1. Organization and Management

12VAC5-410-170. Ownership.

Article 1
Organization and Management

A. There shall be disclosure of hospital ownership. In the case of corporations, all individuals or entities holding 5.0% or more of the total ownership shall be identified by name and address.

B. When the owner delegates the operation of a hospital to an individual, corporation or other legal entity by management contract or lease agreement, subsection A shall also be applicable to the operator.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.1, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-180. Governing body.

A. Each hospital shall have an organized governing body or other legal entity responsible for the management and control of the operation.

The governing body or other legal entity may be an individual, group, corporation or governmental agency.

B. The governing body shall be responsible for insuring compliance with these rules and regulations.

C. The governing body shall provide facilities, personnel and other resources necessary to meet patient and program needs.

D. The governing body shall adopt and maintain written bylaws, rules and regulations in accordance with legal requirements. A copy of said bylaws, rules and regulations including amendments or revisions thereto, shall be made available to the OLC on request.

E. The bylaws, rules and regulations shall include:

1. A statement of purpose;

2. A statement of qualifications for membership and method of selecting members of the governing body;

3. Provisions for the establishment, selection, term of office of committee members and officers;

4. Description of the functions and duties of the governing body, officers, and committees;

5. Specifications for the frequency of meetings, attendance requirements, provision for the order of business and the maintenance of written minutes;

6. A statement of the authority and responsibility delegated to the chief executive officer and to the medical staff;

7. Provision for the selection and appointment of medical staff and the granting of clinical privileges including the provision for current license to practice in Virginia.

8. Provision for the adoption of the medical staff bylaws, rules and regulations;

9. Provision of guidelines for the relationships among the governing body, the chief executive officers, and the medical staff.

10. A policy statement concerning the development and implementation of short- and long-range plans in accordance with Part III (12VAC5-410-650 et seq.) of this chapter.

11. A policy statement relating to conflict of interest on the part of members of the governing body, medical staff and employees who may influence corporate decisions.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.2, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-190. Chief executive officer.

A. The chief executive officer shall be directly responsible to the governing body for the management and operation of the hospital and shall provide liaison between the governing body and the medical staff.

B. The chief executive officer, or his designee, shall ensure that families of patients who are potential donors are informed of the option of organ, tissue, and eye donation.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-200. Organization.

A. The internal hospital organization shall be structured to include appropriate departments and services consonant with its statement of purpose.

B. Each hospital shall maintain clearly written definitions of its organization, authority, responsibility, and relationships.

C. Each hospital department and service shall maintain:

1. Clearly written definitions of its organization, authority, responsibility, and relationships; and

2. Written policies and procedures including:

a. Patient care where applicable;

b. Infection prevention;

c. Disaster preparedness; and

d. Facility security.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.4, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 28, Issue 2, eff. November 1, 2011.

12VAC5-410-210. Medical staff.

A. Each hospital shall have an organized medical staff responsible to the governing body of the hospital for its own organized governance and all medical care provided to patients. Nothing in this subsection shall prevent hospitals that are a part of a hospital system from having a unified and integrated medical staff as permitted by 42 CFR 482.22(b)(4).

B. The medical staff shall be responsible to the hospital governing board and maintain appropriate standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review, and other appropriate mechanisms.

C. The medical staff, subject to approval by the governing body, shall develop bylaws incorporating details of the medical staff organization and governance, giving effect to its general powers, duties, and responsibilities including:

1. Methods of selection, election, or appointment of all officers and other executive committee members and officers;

2. Provisions for the selection and appointment of officers of departments or services specifying required qualifications;

3. The type, purpose, composition, and organization of standing committees;

4. Frequency and requirements for attendance at staff and departmental meetings;

5. An appeal mechanism for denial, revocation, or limitation of staff appointments, reappointments, and privileges;

6. Delineation of clinical privileges in accordance with the requirements of § 32.1-134.2 of the Code of Virginia;

7. Requirements regarding medical records;

8. A mechanism for utilization and medical care review; and

9. Such other provisions as shall be required by hospital or governmental rules and regulations.

D. A copy of approved medical staff bylaws and regulations and revisions thereto shall be made available to the OLC on request.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.5, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 32, Issue 14, eff. April 22, 2016.

12VAC5-410-220. Organ donation.

A. The hospital shall develop and implement a routine contact protocol for organ, tissue and eye donation in compliance with federal law and the regulations of the Centers for Medicare and Medicaid Services (CMS), particularly 42 CFR 482.45.

B. The protocol shall:

1. Ensure that the hospital collaborates with its designated organ procurement organization (OPO) to inform the family of each potential donor of the option of organ, tissue, and eye donation as well as the option to decline to donate;

2. Recite provisions of § 32.1-290.1 of the Code of Virginia specifying family members who are authorized to make an anatomical gift of all or part of the decedent's body for an authorized purpose and the order of priority of those family members who may make such gift; and

3. Include written procedures for organ, tissue, and eye donation. The procedures shall include:

a. Training of staff in organ, tissue, or eye donation;

b. A mechanism for informing the next of kin of the organ, tissue, and eye donation option;

c. Procedures to be employed when the hospital, consistent with the authority granted by § 32.1-292.1 of the Code of Virginia, deems it appropriate to conduct a reasonable search for a document of gift or other information identifying the bearer as a donor or as an individual who has refused to make an anatomical gift;

d. Provisions for the procurement and maintenance of donated organs, tissues, and eyes;

e. The name and telephone number of the local organ procurement agency, tissue or eye bank to be notified of potential donors; and

f. Documentation of the donation request in the patient's medical record.

C. The hospital shall have an agreement with an OPO certified by CMS:

1. To notify the OPO in a timely manner of all deaths or imminent deaths of patients in the hospital; and

2. Authorizing the OPO to determine the suitability of the decedent or patient for organ donation and the suitability for tissue and eye donation in the absence of a similar arrangement with any eye bank or tissue bank in Virginia certified by the Eye Bank Association of America or the American Association of Tissue Banks.

D. The hospital shall have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes to ensure that all usable tissues and eyes are obtained from potential donors and to avoid interference with organ procurement.

E. The individual making contact with the family shall have completed a course in the methodology for approaching potential donor families and requesting organ or tissue donation that:

1. Is offered or approved by the OPO and designed in conjunction with the tissue and eye bank community; and

2. Encourages discretion and sensitivity according to the specific circumstances, views, and beliefs of the relevant family.

F. The hospital shall work cooperatively with its designated OPO in educating its staff on:

1. Donation issues;

2. The proper review of death records to improve identification of potential donors; and

3. The proper procedures for maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

G. The protocol shall be followed, without exception, unless the family of the relevant decedent or patient expresses opposition to organ donation, the chief administrative officer of the hospital or his designee knows of such opposition, and no donor card or other relevant document, such as an advance directive, can be found.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 17, Issue 1, eff. October 27, 2000; Volume 23, Issue 10, eff. March 1, 2007.

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