Administrative Code

Virginia Administrative Code
1/30/2023

Part IV. Outpatient Surgical Hospitals: Organization, Operation, and Design Standards for Existing and New Facilities

Article 1
Organization and Management

12VAC5-410-1150. Governing authority.

Article 1
Organization and Management

A. Each outpatient surgical hospital shall have a governing body or other legal authority responsible for the management and control of the operation of the facilities.

B. There shall be disclosure of hospital ownership. Ownership interest shall be made known to the OLC and in the case of corporations, all individuals or entities holding 5.0% or more of total ownership shall be identified by name and address. The OLC shall be notified of any changes in ownership.

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

D. The governing body shall have a formal organizational plan with written bylaws, rules and regulations or their equivalent. These shall clearly set forth organization, duties, responsibilities, accountability, and relationships of professional staff and other personnel. The person or organizational body responsible for formulating policies shall be identified.

E. The bylaws, rules and regulations, or their equivalent, shall include at least the following:

1. A statement of purpose;

2. Description of the functions and duties of the governing body, or other legal authority;

3. A statement of authority and responsibility delegated to the chief administrative officer and to the medical staff;

4. Provision for selection and appointment of medical staff and granting of clinical privileges:

5. Provision of guidelines for relationships among the governing body, the chief administrative officer, and the medical staff.

F. The responsibility for administration and management of the outpatient surgical hospital shall be vested in an individual whose qualifications, authority and duties shall be defined in a written statement adopted by the governing body.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.1, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007.

Article 2
Policies and Procedures

12VAC5-410-1160. General statement.

Article 2
Policies and Procedures

Policies and procedures may vary depending on scope and type of service, personnel, equipment and location of the facility. It is recognized that no two facilities will be identical because of variations in the scope and objective of the outpatient service. Even though each facility may be different, certain standards and procedures shall be applicable to all in assuring the delivery of a high quality of care.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.2, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1170. Policy and procedures manual.

A. Each outpatient surgical hospital shall develop a policy and procedures manual that shall include provisions covering the following items:

1. The types of emergency and elective procedures that may be performed in the facility.

2. Types of anesthesia that may be used.

3. Admissions and discharges, including:

a. Criteria for evaluating the patient before admission and before discharge; and

b. Protocols to ensure that any patient scheduled to receive an elective surgical procedure for which the patient can reasonably be expected to require outpatient physical therapy as a follow-up treatment after discharge is informed that the patient:

(1) Is expected to require outpatient physical therapy as a follow-up treatment; and

(2) Will be required to select a physical therapy provider prior to being discharged from the hospital.

4. Written informed consent of patient prior to the initiation of any procedures.

5. Procedures for housekeeping and infection control and prevention.

6. Disaster preparedness.

7. Facility security.

B. A copy of approved policies and procedures and revisions thereto shall be made available to the OLC upon request.

C. Each outpatient surgical hospital shall establish a protocol relating to the rights and responsibilities of patients based on Joint Commission on Accreditation of Healthcare Organizations' Standards for Ambulatory Care (2000 Hospital Accreditation Standards, January 2000). The protocol shall include a process reasonably designed to inform patients of their rights and responsibilities. Patients shall be given a copy of their rights and responsibilities upon admission.

D. If the Governor has declared a public health emergency related to the novel coronavirus (COVID-19), each outpatient surgical hospital shall allow a person with a disability who requires assistance as a result of such disability to be accompanied by a designated support person at any time during which health care services are provided.

1. A designated support person shall not be subject to any restrictions on visitation adopted by such outpatient surgical hospital. However, such designated support person may be required to comply with all reasonable requirements of the outpatient surgical hospital adopted to protect the health and safety of patients and staff of the outpatient surgical hospital.

2. Every outpatient surgical hospital shall establish policies applicable to designated support persons and shall:

a. Make such policies available to the public on a website maintained by the outpatient surgical hospital; and

b. Provide such policies, in writing, to the patient at such time as health care services are provided.

E. Each outpatient surgical hospital shall obtain a criminal history record check pursuant to § 32.1-126.02 of the Code of Virginia on any compensated employee not licensed by the Board of Pharmacy whose job duties provide access to controlled substances within the outpatient surgical hospital pharmacy.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 19, Issue 1, eff. November 1, 2002; Volume 23, Issue 10, eff. March 1, 2007; Volume 28, Issue 2, eff. November 1, 2011; Volume 36, Issue 23, eff. August 6, 2020; Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-410-1175. Discharge planning.

A. Every hospital shall provide each patient admitted as an inpatient or his legal guardian the opportunity to designate an individual who will care for or assist the patient in his residence following discharge from the hospital and to whom the hospital shall provide information regarding the patient's discharge plan and any follow-up care, treatment, and services that the patient may require.

B. Every hospital upon admission shall record in the patient's medical record:

1. The name of the individual designated by the patient;

2. The relationship between the patient and the person; and

3. The person's telephone number and address.

C. If the patient fails or refuses to designate an individual to receive information regarding his discharge plan and any follow-up care, treatment, and services, the hospital shall record the patient's failure or refusal in the patient's medical record.

D. A patient may change the designated individual at any time prior to the patient's release, and the hospital shall record the changes, including the information referenced in subsection B of this section, in the patient's medical record within 24 hours of such a change.

E. Prior to discharging a patient who has designated an individual pursuant to subsection A or D of this section, the hospital shall (i) notify the designated individual of the patient's discharge, (ii) provide the designated individual with a copy of the patient's discharge plan and instructions and information regarding any follow-up care, treatment, or services that the designated individual will provide, and (iii) consult with the designated individual regarding the designated individual's ability to provide the care, treatment, or services. Such discharge plan shall include:

1. The name and contact information of the designated individual;

2. A description of follow-up care, treatment, and services that the patient requires; and

3. Information, including contact information, about any health care, long-term care, or other community-based services and supports necessary for the implementation of the patient's discharge plan.

A copy of the discharge plan and any instructions or information provided to the designated individual shall be included in the patient's medical record.

F. The hospital shall provide each individual designated pursuant to subsection A or D of this section the opportunity for a demonstration of specific follow-up care tasks that the designated individual will provide to the patient in accordance with the patient's discharge plan prior to the patient's discharge, including opportunity for the designated individual to ask questions regarding the performance of follow-up care tasks. Such opportunity shall be provided in a culturally competent manner and in the designated individual's native language.

Statutory Authority

§ 32.1-127 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 14, eff. April 8, 2016.

Article 3
Staffing

12VAC5-410-1180. Medical staff.

Article 3
Staffing

A. The size and organizational structure of the medical staff will vary depending on the scope of service.

1. Professional and clinical services shall be supervised by a physician licensed to practice medicine or surgery in Virginia.

2. Surgical procedures shall be performed by a physician licensed to perform such procedures in Virginia.

3. Clinical privileges of physician and nonphysician practitioners shall be clearly defined.

4. Credentials including education and experience shall be reviewed and privileges identified, established, and approved for each person allowed to diagnose, treat patients or perform surgical procedures in accordance with guidelines, policies or bylaws adopted by the governing body and approved by the medical staff.

B. No medication or treatment shall be given except on the signed order of a person lawfully authorized by state statute.

1. Outpatient surgical hospital personnel, as designated in medical staff bylaws, rules and regulations, or policies and procedures, may accept emergency telephone and other verbal orders for medication or treatment for outpatient surgical hospital patients from physicians and other persons lawfully authorized by state statute to give patient orders.

2. As specified in the hospital's medical staff bylaws, rules and regulations, or hospital policies and procedures, emergency telephone and other verbal orders shall be signed within a reasonable period of time not to exceed 72 hours by the person giving the order, or, when such person is not available, cosigned by another physician or other person authorized to give the order.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.4, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 19, Issue 1, eff. November 1, 2002.

12VAC5-410-1190. Nursing staff.

The total number of nursing personnel will vary depending upon the number and types of patients to be admitted and the types of operative procedures to be performed or the services programmed.

1. A registered nurse qualified on the basis of education, experience, and clinical ability shall be responsible for the direction of nursing care provided the patients.

2. The number and type of nursing personnel, including registered nurses, licensed practical nurses, and supplementary staff, shall be based upon the needs of the patients and the types of services performed.

3. At least one registered nurse shall be on duty at all times while the facility is in use.

4. Job descriptions shall be developed for each level of nursing personnel and include functions, responsibilities, and qualifications.

5. Evidence of current Virginia registration required by state statute shall be on file in the facility.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.5, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

Article 4
Patient Care Services

12VAC5-410-1200. Anesthesia service.

Article 4
Patient Care Services

A. The anesthesia service shall be directed by and under the supervision of a physician licensed to practice medicine or surgery in Virginia.

B. The physician responsible for the anesthesia service shall be present for the administration of anesthetics and recovery of patients when any general or major regional anesthetic is used.

C. There shall be written procedures to assure safety in storage and use of inhalation anesthetics and medical gases.

D. Unless the hospital program and official written action by the governing body prohibit use of flammable anesthetics, the requirements of 12VAC5-410-240 of this chapter must be met.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1210. Sterile supply services.

A. Adequate provisions shall be maintained for the processing, sterilizing, storing, and dispensing of clean and sterile supplies and equipment.

B. Written procedures shall be established for the appropriate disposal of pathological and other potentially infectious waste and contaminated supplies.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.7, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1220. Dietary service.

If the program calls for the dietary service, serving of snacks or other foods, adequate space, equipment, and supplies shall be provided. Applicable state and local codes pertaining to receiving, storage, refrigeration, preparation, and serving of food shall be followed.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.8, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1230. Evacuation plan.

A. Each outpatient surgical hospital shall develop a written evacuation plan to assure reasonable precautions are taken to protect patients, employees, and visitors from hazards of fire and other disaster. The evacuation plan shall provide:

B. A program to acquaint all personnel with evacuation procedures shall be maintained.

C. A copy of the plan and procedures shall be made available to the Office upon request.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.9, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1240. Emergency services.

A. Each outpatient surgical hospital shall provide emergency service and maintain on the premises adequate monitoring equipment, suction apparatus, oxygen, and related items necessary for resuscitation and control of hemorrhage and other complications.

B. A written agreement which ensures emergency transportation to a licensed general hospital shall be executed with an ambulance service.

C. A written agreement shall be executed with a general hospital to ensure that any patient of the outpatient surgical hospital shall receive needed emergency treatment. The agreement shall be within a licensed general hospital capable of providing full surgical, anesthesia, clinical laboratory, and diagnostic radiology service on 30 minutes notice and which has a physician in the hospital and available for emergency service at all times.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.10, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1250. Laboratory and pathology services.

A. Laboratory and pathology services each patient admitted to the outpatient surgical hospital shall receive appropriate laboratory testing according to 42 CFR Part 493.

B. All tissue removed shall be submitted for histological examination by a pathologist and a written report of his examination provided to the attending physician. The report of findings shall be filed in the patient's clinical record.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.11, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1260. Medical records.

A. Medical records. An accurate and complete clinical record or chart shall be maintained on each patient. The record or chart shall contain sufficient information to satisfy the diagnosis or need for the medical or surgical service. It shall include, when applicable, but not be limited to the following:

1. Patient identification;

2. Admitting information, including patient history and physical examination;

3. Signed consent;

4. Confirmation of pregnancy, if applicable;

5. Physician orders;

6. Laboratory tests, pathologist's report of tissue, and radiologist's report of x-rays;

7. Anesthesia record;

8. Operative record;

9. Surgical medication and medical treatments;

10. Recovery room notes;

11. Physician and nurses' progress notes,

12. Condition at time of discharge,

13. Patient instructions, preoperative and postoperative;

14. Names of referral physicians or agencies.

B. Provisions shall be made for the safe storage of medical records or accurate and legible reproductions thereof according to § 32.1-127.1:03 of the Code of Virginia and the Health Insurance Portability and Accountability Act, or HIPAA (42 USC § 1320d et seq.).

C. All medical records, either original or accurate reproductions, shall be preserved for a minimum of five years following discharge of the patient.

1. Records of minors shall be kept for at least five years after such minor has reached the age of 18 years.

2. Birth and death information shall be retained for 10 years in accordance with § 32.1-274 of the Code of Virginia.

3. Record of abortions and proper information for the issuance of a fetal death certificate shall be furnished the Division of Vital Records, Virginia Department of Health, within 10 days after the abortion.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.12, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1270. Preoperative admission.

A. Prior to the initiation of any procedure, a medical history and physical examination shall be completed for each patient.

B. Where medical evaluation, examination, and referrals are made from a private physician's office, another hospital, clinic, or medical service pertinent available records thereof shall be made and included as a part of the patient's medical record at the time the patient is admitted to the outpatient surgical hospital.

C. Sufficient time shall be allowed between initial examination and initiation of any procedure to permit the reporting and review of laboratory tests by the responsible physician.

D. In outpatient surgical hospitals which provide abortion services, the diagnosis of pregnancy shall be the responsibility of the physician performing the abortion procedure.

E. Outpatient surgical hospitals which provide abortion services shall offer each patient appropriate counseling and instruction in the abortion procedure and in birth control methods.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.13, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1280. Post-operative recovery.

A. Each patient shall be observed for post-operative complications under the direct supervision of a registered professional nurse. Recovery room nurses shall have specialized training in resuscitation techniques and other emergency procedures consistent with policies and procedures of the institution for designated special units.

B. A physician licensed in Virginia shall be present on the premises at all times during the operative and post-operative period until discharge of the patient.

C. Patients shall be discharged from the recovery only on written order of the attending physician.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.14, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1290. Environment and maintenance.

A. All parts of the outpatient surgical hospital and its premises shall be kept clean, neat, and free of litter and rubbish.

B. Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other materials.

C. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.15, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1300. Laundry services.

A. Each outpatient surgical hospital shall make provisions for the cleaning of all linens.

B. There shall be distinct areas for the separate storage and handling of clean and soiled linens.

C. All soiled linen shall be placed in closed containers prior to transportation.

Statutory Authority

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

Historical Notes

Derived from VR355-33-500 § 4.16, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1310. (Repealed.)

Historical Notes

Derived from VR355-33-500 § 4.17, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1320. (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 5.1-5.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

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