Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-260).

Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 14, 2016.

Agency Contact: Susan Puglisi, Policy Analyst, Department of Health, 9960 Mayland Drive, Richmond, VA 23233, telephone (804) 367-2157, FAX (804) 527-4502, or email susan.puglisi@vdh.virginia.gov.

Basis: The regulation is promulgated under the authority of §§ 32.1-12 and 32.1-127 of the Code of Virginia. Section 32.1-12 grants the board the legal authority "to make, adopt, promulgate, and enforce such regulations necessary to carry out the provisions of Title 32.1 of the Code." Section 32.1-127 of the Code of Virginia directs the board to promulgate regulations with minimum standards for the construction and maintenance of hospitals, the operation, staffing and equipping of hospitals, qualifications and training of staff of hospitals, conditions under which a hospital may provide medical and nursing services to patients in their places of residence, and policies related to infection prevention, disaster preparedness, and facility security.

Purpose: The federal Centers for Medicare and Medicaid Services (CMS) issued a final rule on May 12, 2014, that enables a qualified dietitian or qualified nutrition professional to become privileged to independently order both standard and therapeutic diets within the hospital and critical access hospital settings. According to the CMS rule, hospitals will have the flexibility to either (i) appoint registered dieticians to the medical staff and grant them specific nutritional ordering privileges or (ii) authorize ordering privileges without appointment to the medical staff through the hospital’s appropriate medical staff rules, regulations, and bylaws. This rule change became effective on July 11, 2014. 12VAC5-410-260 is currently written in a manner that is more restrictive than the federal regulations because it only allows registered dietitians to write independent nutrition orders in hospitals if they are appointed to the medical staff. This regulatory action will amend the regulations to remove restrictions that are more stringent than federal law. This regulatory action will protect the health and welfare of Virginians by ensuring that patients within a hospital setting are able to obtain the proper standard and therapeutic diets within the Commonwealth.

Rationale for Using Fast-Track Process: These amendments simply ensure that the Commonwealth's regulations are not more restrictive than federal regulations. These amendments have also been prepared with input from the Virginia Academy of Nutrition and Dietetics. Therefore, the department does not expect that this regulatory action will be controversial.

Substance: Amendments to 12VAC5-410-260 remove the requirement that all patient diets be ordered in writing by a member of the medical staff; allow practitioners responsible for the care of the patient, or dietitians authorized by the medical staff, to order patient diets; and allow a hospital or medical staff to privilege qualified dietitians to prescribe diets and order tests to determine appropriate diets for the patient and specify that therapeutic diets include the provision of enteral and parenteral nutrition.

Issues: The primary advantage to the agency, the Commonwealth, and the public of the proposed regulatory action will be less burdensome regulations. The proposed regulatory action will also lead to greater access to well-rounded patient care. There are no known disadvantages to the agency, the Commonwealth, or the public.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The federal Centers for Medicare and Medicaid Services (CMS) issued a final rule on May 12, 2014, which enables a qualified dietitian or qualified nutrition professional to become privileged to independently order both standard and therapeutic diets within the hospital and critical access hospital settings. This rule change became effective on July 11, 2014. The State Board of Health (Board) proposes to amend this regulation to reflect this change.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The current regulation requires that all patient diets be ordered in writing by a member of the medical staff. The Board proposes to amend this requirement to state that all patient diets be ordered in writing by a practitioner responsible for the care of the patient or by a dietitian as authorized by the medical staff. The proposed new language will permit medical staff to use their time more efficiently. Permitting a qualified dietician authorized by the medical staff to do the ordering will enable the medical staff to spend the time they otherwise would have spent on the ordering of diets on other productive health care tasks such as diagnosing and treating patients, etc.

Businesses and Entities Affected. The proposed amendments affect qualified dietitians, the 106 licensed hospitals and critical access hospitals within the Commonwealth, and patients served by hospitals throughout Virginia.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposal to permit authorized dieticians not on the medical staff to order both standard and therapeutic diets within the hospital may encourage hospitals to employ more dieticians for this purpose.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments will not adversely affect small businesses.

Adverse Impacts:

Businesses: The proposed amendments will not adversely affect businesses.

Localities: The proposed amendments will not adversely affect localities.

Other Entities: The proposed amendments will not adversely affect other entities.

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the Department of Planning and Budget's economic impact analysis.

Summary:

The amendments (i) remove the requirement that all patient diets be ordered in writing by a member of the medical staff; (ii) add language allowing practitioners responsible for the care of the patient, or dietitians authorized by the medical staff, to order patient diets; and (iii) allow a hospital or medical staff to privilege qualified dietitians to prescribe diets and order tests to determine appropriate diets for the patient and specify that therapeutic diets include the provision of enteral and parenteral nutrition.

12VAC5-410-260. Dietary service.

A. Each hospital shall maintain a dietary service directed by a full-time person, qualified as allowed in 12VAC5-421.

B. Each hospital shall have at least one dietitian, meeting the criteria of § 54.1-2731 of the Code of Virginia, employed on either a full-time, part-time or on a consultative basis, to direct nutritional aspects of patient care and to advise on food preparation and service.

C. Space, equipment and supplies shall be provided for the efficient, safe and sanitary receiving, storage, refrigeration, preparation and serving of food.

D. The hospital food service operation shall comply with applicable standards in 12VAC5-421.

E. A diet manual, approved by the medical staff shall be maintained by the dietary service. Diets served to patients shall comply with the principles set forth in the diet manual.

F. All patient diets shall be ordered in writing by a member of the medical staff, including therapeutic diets, shall be ordered in writing by a practitioner, or by a dietitian as authorized by the medical staff, responsible for the care of the patient.

1. Hospitals and their medical staffs may grant privileges to dietitians meeting the criteria of § 54.1-2731 of the Code of Virginia to order patient diets, including therapeutic diets, and to order laboratory tests to help determine appropriate diets for the patient.

2. Therapeutic diets include the provision of enteral and parenteral nutrition.

G. Pertinent observations and information relative to the special diets and to dietetic treatment shall be recorded in the patient's medical record.

H. A hospital contracting for food service shall require, as part of the contract, that the contractor comply with the provisions of this section.