July 27, 2020

Erik Bodin

Director, Office of Licensure and Certification

Virginia Department of Health

9960 Mayland Drive, Suite 401

Henrico, Virginia 23233

            RE:      Public Comment for Periodic Review of 12 VAC 5-410 

Dear Mr. Bodin,

Thank you for the opportunity to comment on the Virginia Board of Health periodic review and small business impact review of 12 VAC 5-410, Regulations for the Licensure of Hospitals in Virginia (the “Hospital Licensure Regulations” or “Hospital Licensure Regulations”).  As discussed in greater detail below, the Virginia Hospital & Healthcare Association (VHHA) submits that this regulation should be retained and has provided suggestions for how the regulation could be further improved.

1. The Hospital Licensure Regulations are Necessary for the Protection of the Public Health, Safety, and Welfare and for the Economical Performance of Important Governmental Functions

The Hospital Licensure Regulations adopted by the Virginia Department of Health establish the baseline from which hospitals must operate their facilities in order to legally operate within the Commonwealth. Promulgated under Va. Code §§ 32.1-12 and 127, the Hospital Licensure Regulations are enacted to ensure “substantial conformity to the standards of health, hygiene, sanitation, construction and safety as established and recognized by medical and health care professionals and by specialists in matters of public health and safety…”  Such regulations include: (i) construction and maintenance of hospitals to ensure the environmental protection and the life safety of its patients, employees, and the public; (ii) the operation, staffing and equipping of hospitals; (iii) qualifications and training of staff of hospitals, except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital may provide medical and nursing services to patients in their places of residence; and (v) policies related to infection prevention, disaster preparedness, and facility security of hospitals. The Hospital Licensure Regulations are critical to public health, safety, and welfare and for the economic performance of important governmental functions as outlined below.

The Hospital Licensure Regulations are necessary for the economical performance of important governmental functions and to protect the public health and safety in several ways, such as:

1. outlining the requirements for the medical staff that will maintain appropriate standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review, and other appropriate mechanisms;
2. establishing patient care management processes and requirements, such as requiring reliable methods for identification of each patient, visitation policies, and policies that determine the medical or ethical appropriateness of medical care;
3. requiring staffing, safety, and quality standards for various services offered at hospitals; and
4. directing hospitals to develop disaster and mass casualty programs.

In the absence of the Hospital Licensure Regulations to establish the minimum safety standards for hospitals, it is possible services could be offered at generally unsafe facilities, facilities with varying standards of quality that could be detrimental to patient outcomes, or facilities that are ill-equipped to deal with emergency situations. 

Today’s hospitals aspire to the highest safety and quality standards in order to continue their work healing all the Virginians. The Hospital Licensure Regulations support these efforts by setting performance standards and expectations for patient care. Patients that enter licensed facilities in Virginia can feel reassured that the facility the patient is entering has been licensed by the Commonwealth of Virginia to adhere to at least a minimum standard of care that is widely accepted by medical professionals. This level of trust in our institutions is essential and is demonstrated, in part, through adhering to the Hospital Licensure Regulations and surpassing them in every manner possible.

However, one area of potential improvement could be streamlining 12 VAC 5 410-443. This section establishes the hospital’s newborn service levels from level 1 to 4 with 4 being the most highly specialized and complex care. The American Academy of Pediatrics (AAP) in their Guidelines for Perinatal Care has published criteria for defining similar newborn service levels that differ from what the Commonwealth has adopted. In the interest of maintaining the latest standard of clinical care for infants, we recommend that Office of Licensure and Certification review the latest research and guidelines adopted by the AAP to determine if there could be a public health benefit to conforming to these national standards.

In short, the Hospital Licensure Regulations play an important role in ensuring patient care remains paramount to all stakeholders in the Commonwealth. Maintenance of the existing Hospital Licensure Regulations is essential absent any compelling advancements in safety or quality that warrant statewide compliance due to the standards representing a significant leap in existing practices such as those that may be offered by the AAP Guidelines for Perinatal Care. VHHA and its member hospitals and hospital systems will continue to pursue these new practices and will advocate for their inclusion in future regulations.

2. Hospital Licensure Regulations Achieve Their Intended Objective in the Most Efficient, Cost Effective Manner

The objective of the Hospital Licensure Regulations, as outlined in Section I, have been implemented in the most efficient, cost effective manner by the current set of regulations. Aside from the benefits noted elsewhere in this comment, the Hospital Licensure Regulations are no more broad or narrow than required to fulfill their intended purpose. The regulations have also been promulgated with the continuous input of stakeholders with expertise in the subject matter and requisite credentials to provide informed input on any proposed changes. The Hospital Licensure Regulations have been continuously updated in an efficient manner by the Board of Health and are widely accepted by those in the industry. As a result of the foregoing, the Hospital Licensure Regulations achieve their intended objective in the most efficient, cost effective manner possible.

3. Hospital Licensure Regulations are Clearly Written and Easily Understandable

Generally speaking, the Hospital Licensure Regulations are concise, clearly written and easily understandable.  The licensure process is fairly complex and detail-oriented, yet the standards and criteria contained in the Hospital Licensure Regulations are based on objective and well-establish standards of safety and quality that are widely accepted in our Commonwealth and many other parts of the country. The criteria are also current – thanks to routine reviews such as this one.

Nevertheless, we have identified areas of the Hospital Licensure Regulations that could benefit from greater specificity or clarity. Specifically, we would like to provide the following suggestions or observations:

• 12 VAC 5 410-60. Separate License.
  • Consider defining “premises” and “grounds” or streamline the definitions by creating a combined “campus” definition.
• 12 VAC 5 410-20. Exceptions; variances.
  • “Surgery” is not defined in 12 VAC 5-410-10 as stated in this section.
• 12 VAC 5 410-110. Bed capacity.
  • Consider requiring licenses issued by the Commissioner include the number of approved operating rooms as well.
• 12 VAC 5 140-170. Ownership.
  • Consider addressing ownership for hospitals with entity forms other than corporations such as LLCs.
• 12 VAC 5 410-470. Outpatient (ambulatory care). and 12 VAC 5 410-1150. Governing authority. et seq.
  • With regards to outpatient surgical hospital regulations, we recommend that the Office of Licensure and Certification remove these sections of the regulation from the Hospital Licensure Regulations and consider establishing a new chapter specifically for outpatient surgical hospitals to include the current regulations. The current organization can be confusing and makes it difficult to find these regulations.

Thank you again for this opportunity to comment.

Sincerely,

R. Brent Rawlings

Senior Vice President & General Counsel