EFFLUENT CHARACTERISTICS	DISCHARGE LIMITATIONS			MONITORING REQUIREMENTS
	Monthly Average	Daily Minimum	Daily Maximum	Frequency(3)	Sample Type
Flow (MGD)	NL	NA	NL	1/3 Months	Estimate
Total Suspended Solids (mg/l)	30	NA	60	1/3 Months	Grab
pH (standard units)	NA	6.0* 6.0(1)	9.0* 9.0(1)	1/3 Months	Grab
Total Petroleum Hydrocarbons (mg/l)** (mg/l)(2)	NA	NA	NL	1/3 Months	Grab
NL = No Limitation, monitoring required NA = Not Applicable *Where (1)Where the Water Quality Standards (9VAC25-260) establish alternate standards for pH, pH effluent limits may be adjusted within the 6 to 9 S.U. range. **Monitoring (2)Monitoring for Total Petroleum Hydrocarbons is only required for outfalls from vehicle/equipment washing facilities or from discharges that pass through oil/water separators. (3)Discharge Monitoring Reports (DMRs) of quarterly monitoring shall be submitted to the DEQ regional office no later than the 10th day of April, July, October, and January.

2. There shall be no discharge of floating solids or visible foam in other than trace amounts.

3. During the period beginning with the permittee's coverage under the general permit and lasting until the permit's expiration date, the permittee is authorized to discharge storm water associated with industrial activity which does not combine with other wastewaters prior to discharge from outfall(s).

Such discharges shall be limited and monitored by the permittee as specified below:

EFFLUENT CHARACTERISTICS	DISCHARGE LIMITATIONS			MONITORING REQUIREMENTS
	Monthly Average	Daily Minimum	Daily Maximum	Frequency(2)	Sample Type
Flow (MG)	NA	NA	NL	1/Year	Estimate* Estimate(1)
Total Suspended Solids (mg/l)	NA	NA	NL(3)	1/Year	Grab
pH (standard units)	NA	NL	NL	1/Year	Grab
NL = No Limitation, monitoring required NA = Not applicable *Estimate (1)Estimate of the total volume of the discharge during the storm event. (2)Discharge Monitoring Reports (DMRs) of yearly monitoring (January 1 to December 31) shall be submitted to the DEQ regional office no later than the 10th day of January. (3)Refer to Part I B 13 should the TSS evaluation monitoring exceed 100 mg/l daily maximum.

4. All samples taken to meet the monitoring requirements specified above in A. 3 Part I A 3 shall be collected from the discharge resulting from a storm event that is greater than 0.1 inches in magnitude. and that occurs at least 72 hours from the previously measurable (greater than 0.1 inch rainfall) storm event. The grab sample shall be taken during the first 30 minutes of the discharge. If the collection of a grab sample during the first 30 minutes is impracticable, a grab sample can be taken during the first hour of the discharge, and the permittee shall submit with the monitoring report a description of why a grab sample during the first 30 minutes was impracticable.

B. Special conditions.

1. Vehicles and equipment utilized during the industrial activity on a site must be operated and maintained in such a manner as to prevent the potential or actual point source pollution of the surface or groundwaters of the state. Fuels, lubricants, coolants, and hydraulic fluids, or any other petroleum products, shall not be disposed of by discharging on the ground or into surface waters. Spent fluids shall be disposed of in a manner so as not to enter the surface or groundwaters of the state and in accordance with the applicable state and federal disposal regulations. Any spilled fluids shall be cleaned up to the maximum extent practicable and disposed of in a manner so as not to allow their entry into the surface or groundwaters of the state.

2. No sewage shall be discharged from this mineral mining activity except under the provisions of another VPDES permit specifically issued for that purpose.

3. There shall be no chemicals added to the discharge, other than those listed on the owner's approved registration statement.

4. The permittee shall submit a new registration statement if the mining permit approved by the Division of Mineral Mining (or associated waivered program, or bordering state mine authority) is modified or reissued in any way that would affect the outfall location or the characteristics of a discharge covered by this general permit. Government owned and operated mines without mining permits shall submit the registration statement whenever outfall location or characteristics are altered. The new registration statement shall be filed within 30 days of the outfall relocation or change in the characteristics of the discharge.

5. The permittee shall notify the department as soon as they know or have reason to believe:

a. That any activity has occurred or will occur which would result in the discharge, on a routine or frequent basis, of any toxic pollutant which is not limited in this permit, if that discharge will exceed the highest of the following notification levels:

(1) One hundred micrograms per liter (100 μg/l);

(2) Two hundred micrograms per liter (200 μg/l) for acrolein and acrylonitrile; five hundred micrograms per liter (500 μg/l) for 2,4-dinitrophenol and for 2-methyl-4,6-dinitrophenol; and one milligram per liter (1 mg/l) for antimony;

(3) Five times the maximum concentration value reported for that pollutant in the permit application; or

(4) The level established by the board.

b. That any activity has occurred or will occur which would result in any discharge, on a nonroutine or infrequent basis, of a toxic pollutant which is not limited in this permit, if that discharge will exceed the highest of the following notification levels:

(1) Five hundred micrograms per liter (500 μg/l);

(2) One milligram per liter (1 mg/l) for antimony;

(3) Ten times the maximum concentration value reported for that pollutant in the permit application; or

(4) The level established by the board.

6. This permit shall be modified, or alternatively revoked and reissued, to comply with any applicable effluent standard or limitation or prohibition for a pollutant which is promulgated or approved under § 307(a)(2) of the federal Clean Water Act, if the effluent standard or limitation so issued or approved:

a. Is more stringent than any effluent limitation on the pollutant already in the permit; or

b. Controls any pollutant not limited in the permit.

7. Except as expressly authorized by this permit, no product, materials, industrial wastes, or other wastes resulting from the purchase, sale, mining, extraction, transport, preparation, or storage of raw or intermediate materials, final product, by-product or wastes, shall be handled, disposed of, or stored so as to permit a discharge of such product, materials, industrial wastes, or other wastes to state waters.

8. There shall be no discharge of process wastewater pollutants from co-located colocated asphalt paving materials operations. For the purposes of this special condition, process wastewater pollutants are any pollutants present in water used in asphalt paving materials manufacturing which come into direct contact with any raw materials, intermediate product, by-product or product related to the asphalt paving materials manufacturing process.

9. Process water may be used on site for the purpose of dust suppression. Dust suppression shall be carried out as a best management practice but not as a wastewater disposal method provided that ponding or direct runoff from the site does not occur during or immediately following its application.

10. Process water from mine dewatering may be provided to local property owners for beneficial agricultural use.

11. Vehicle/equipment washing shall include washing with detergents or steam cleaning of engines and other drive components in which the purpose is to clean and decrease the equipment for maintenance and other purposes. The application of water without detergent to a vehicle exterior for the purpose of removing is excluded.

12. The permittee shall report at least two significant digits for a given parameter. Regardless of the rounding convention used (i.e., 5 always rounding up or to the nearest even number) by the permittee, the permittee shall use the convention consistently and shall ensure that consulting laboratories employed by the permittee use the same convention.

13. Storm Water Monitoring Total Suspended Solids (TSS) Evaluation. Permittees that monitor storm water associated with industrial activity which does not combine with other wastewaters prior to discharge shall review the results of the TSS monitoring required by Part I A 3 to determine if changes to the Storm Water Pollution Prevention Plan (SWPPP) may be necessary. If the TSS monitoring results are greater than the evaluation value of 100 mg/l, then the permittee shall perform the inspection and maintain documentation as described in Part II H 3 d for that outfall. Any deficiencies noted during the inspection shall be corrected in a timely manner.

14. Discharges to waters subject to TMDL waste load allocations. Facilities that are an identified source of the specified pollutant of concern to waters for which a "total maximum daily load" (TMDL) waste load allocation has been established by the board and approved by EPA prior to the term of this permit shall incorporate measures and controls into the SWPPP required by Part III that are consistent with the assumptions and requirements of the TMDL. The department will provide written notification to the owner that a facility is subject to the TMDL requirements. The facility's SWPPP shall specifically address any conditions or requirements included in the TMDL that are applicable to discharges from the facility. If the TMDL establishes a specific numeric wasteload allocation that applies to discharges from the facility, the owner shall incorporate that allocation into the facility’s SWPPP, perform any required monitoring in accordance with Part I A 1 c (3), and implement measures necessary to meet that allocation.

Part II
Storm Water Management

A. Recording of results.

1. Additional information. In addition to any reporting requirements of Part III, for each measurement or sample taken pursuant to the storm event monitoring requirements of this permit, the permittee shall record and report with the discharge monitoring report the following information:

a. The date and duration (in hours) of the storm events sampled; and

b. The rainfall measurements or estimates (in inches) of the storm event which generated the sampled discharge; and.

c. The duration between the storm event sampled and the end of the previous measurable (greater than 0.1 inch rainfall) storm event.

2. Additional reporting. In addition to filing copies of discharge monitoring reports in accordance with Part III, permittees with at least one storm water discharge associated with industrial activity through a large or medium municipal separate storm sewer system (systems serving a population of 100,000 or more) or a municipal system designated by the board must submit signed copies of discharge monitoring reports to the operator of the municipal separate storm sewer system at the same time.

B. Representative discharge. When a facility has two or more exclusively storm water outfalls that, based on a consideration of industrial activity, significant materials, and management practices and activities within the area drained by the outfall, the permittee reasonably believes discharge substantially identical effluents, the permittee may test the effluent of one of such outfalls and include with the discharge monitoring report an explanation that the quantitative data also applies to the substantially identical outfalls provided that the permittee includes a description of the location of the outfalls and explains in detail why the outfalls are expected to discharge substantially identical effluents. In addition, for each exclusively storm water outfall that the permittee believes is representative, an estimate of the size of the drainage area (in square feet) and an estimate of the run-off coefficient of the drainage area (e.g., low (under 40%), medium (40% to 65%) or high (above 65%)) shall be provided. the permittee reasonably believes discharge substantially identical effluents, based on a consideration of industrial activity, significant materials, and management practices and activities within the area drained by the outfalls, then the permittee may submit information with the registration statement substantiating the request for only one DMR to be issued for the outfall to be sampled that represents one or more substantially identical outfalls. Also the permittee may list on the discharge monitoring report of the outfall to be sampled all outfall locations that are represented by the discharge.

C. Sampling waiver.

1. Adverse conditions. When a permittee is unable to collect samples within a specified sampling period due to adverse climatic conditions, the permittee shall collect a substitute sample from a separate qualifying event in the next period and submit these data along with the data for the routine sampling in that period. Adverse weather conditions that may prohibit the collection of samples include weather conditions that create dangerous conditions for personnel (such as local flooding, high winds, hurricane, tornadoes, electrical storms, etc.) or otherwise make the collection of a sample impracticable (drought, extended frozen conditions, etc.).

2. Inactive and unstaffed facilities. When a permittee is unable to conduct the storm water sampling required at an inactive and unstaffed facility, the permittee may exercise a waiver of the monitoring requirements as long as the facility remains inactive and unstaffed. The permittee must submit to the department, in lieu of monitoring data, a certification statement on the discharge monitoring report stating that the facility is inactive and unstaffed so that collecting a sample during a qualifying event is not possible.

D. Storm water pollution prevention plans. A storm water pollution prevention plan shall be developed for each facility covered by this permit. Storm water pollution prevention plans shall be prepared in accordance with good engineering practices. The plan shall identify potential sources of pollution which may reasonably be expected to affect the quality of storm water discharges associated with industrial activity from the facility. In addition, the plan shall describe and ensure the implementation of practices which are to be used to reduce the pollutants in storm water discharges associated with industrial activity at the facility and to assure compliance with the terms and conditions of this permit. Facilities must implement the provisions of the storm water pollution prevention plan required under this part as a condition of this permit.

The storm water pollution prevention plan requirements of this general permit may be fulfilled by incorporating by reference other plans or documents such as an erosion and sediment control plan, a mine drainage plan as required by the Virginia Division of Mineral Mining, a spill prevention control and countermeasure (SPCC) plan developed for the facility under § 311 of the federal Clean Water Act or best management practices (BMP) programs otherwise required for the facility provided that the incorporated plan meets or exceeds the plan requirements of Part II H. If an erosion and sediment control plan is being incorporated by reference, it shall have been approved by the locality in which the activity is to occur or by another appropriate plan-approving authority authorized under the Virginia Erosion and Sediment Control Regulations, 4VAC50-30. All plans incorporated by reference into the storm water pollution prevention plan become enforceable under this permit. If a plan incorporated by reference does not contain all of the required elements of the storm water pollution prevention plan of Part II H, the permittee must develop the missing plan elements and include them in the required storm water pollution prevention plan.

E. Deadlines for plan preparation and compliance.

1. Existing facilities and new facilities that begin operation on or before July 1, 2004 2009, shall prepare and implement a plan incorporating the storm water pollution prevention plan requirements of this permit, if not included in an existing plan, as expeditiously as practicable, but not later than July 1, 2005 2010. Existing storm water pollution prevention plans being implemented as of July 1, 2004 2009 shall continue to be implemented until a new plan is developed and implemented.

2. Facilities that begin operation after July 1, 2004 2009, shall prepare and implement a plan incorporating the requirements of this permit prior to submitting the registration statement.

F. Signature and plan review.

1. The plan shall be signed in accordance with Part III K (signatory requirements), and be retained on-site at the facility covered by this permit in accordance with Part III B (records) of this permit. When there are no on-site buildings or offices in which to store the plan, it shall be kept at the nearest company office.

2. The permittee shall make the storm water pollution prevention plan, annual site compliance inspection report, or other information available to the department upon request.

3. The director, or an authorized representative, may notify the permittee at any time that the plan does not meet one or more of the minimum requirements of this part. Such notification shall identify those provisions of the permit which are not being met by the plan, and identify which provisions of the plan require modifications in order to meet the minimum requirements of this part. Within 60 days of such notification from the director, or as otherwise provided by the director, or an authorized representative, the permittee shall make the required changes to the plan and shall submit to the department a written certification that the requested changes have been made.

G. Keeping plans current. The permittee shall amend the plan whenever there is a change in design, construction, operation, or maintenance, which has a significant effect on the potential for the discharge of pollutants to surface waters of the state or if the storm water pollution prevention plan proves to be ineffective in eliminating or significantly minimizing pollutants from sources identified under Part II H 2 (description of potential pollutant sources) of this permit, or in otherwise achieving the general objectives of controlling pollutants in storm water discharges associated with industrial activity. New owners shall review the existing plan and make appropriate changes. Amendments to the plan may be reviewed by the department in the same manner as described in Part II F.

H. Contents of plan. The plan shall include, at a minimum, the following items:

1. Pollution prevention team. Each plan shall identify a specific individual or individuals within the facility organization as members of a storm water pollution prevention team that are responsible for developing the storm water pollution prevention plan and assisting the facility or plant manager in its implementation, maintenance, and revision. The plan shall clearly identify the responsibilities of each team member. The activities and responsibilities of the team shall address all aspects of the facility's storm water pollution prevention plan.

2. Description of potential pollutant sources. Each plan shall provide a description of potential sources which may reasonably be expected to add significant amounts of pollutants to storm water discharges or which may result in the discharge of pollutants during dry weather from separate storm sewers draining the facility. Each plan shall identify all activities and significant materials which may potentially be significant pollutant sources. Each plan shall include, at a minimum:

a. Drainage.

(1) A site map indicating an outline of the portions of the drainage area of each storm water outfall that are within the facility boundaries, each existing structural control measure to reduce pollutants in storm water run-off, surface water bodies, locations where significant materials are exposed to precipitation, locations where major spills or leaks identified under Part II H 2 c (spills and leaks) of this permit have occurred, and the locations of the following activities where such activities are exposed to precipitation: fueling stations, vehicle and equipment maintenance and/or cleaning areas, loading/unloading areas, locations used for the treatment, storage or disposal of wastes and wastewaters, liquid storage tanks, processing areas and storage areas. The map must indicate all outfall locations. The types of discharges contained in the drainage areas of the outfalls must be indicated either on the map or in an attached narrative.

(2) For each area of the facility that generates storm water discharges associated with industrial activity with a reasonable potential for containing significant amounts of pollutants, a prediction of the direction of flow, and an identification of the types of pollutants which are likely to be present in storm water discharges associated with industrial activity. Factors to consider include the toxicity of the chemicals; quantity of chemicals used, produced or discharged; the likelihood of contact with storm water; and history of significant leaks or spills of toxic or hazardous pollutants. Flows with a significant potential for causing erosion shall be identified.

b. Inventory of exposed materials. An inventory of the types of materials handled at the site that potentially may be exposed to precipitation. Such inventory shall include a narrative description of significant materials that have been handled, treated, stored or disposed in a manner to allow exposure to storm water between the time of three years prior to the date of coverage under this general permit and the present; method and location of on-site storage or disposal; materials management practices employed to minimize contact of materials with storm water run-off between the time of three years prior to the date of coverage under this general permit and the present; the location and a description of existing structural and nonstructural control measures to reduce pollutants in storm water run-off; and a description of any treatment the storm water receives.

c. Spills and leaks. A list of significant spills and significant leaks of toxic or hazardous pollutants that occurred at areas that are exposed to precipitation or that otherwise drain to a storm water conveyance at the facility after the date of three years prior to the date of coverage under this general permit. Such list shall be updated as appropriate during the term of the permit.

d. Sampling data. A summary of existing discharge sampling data describing pollutants in storm water discharges from the facility, including a summary of sampling data collected during the term of this permit.

e. Risk identification and summary of potential pollutant sources. A narrative description of the potential pollutant sources from the following activities: loading and unloading operations; outdoor storage activities; outdoor manufacturing or processing activities; significant dust or particulate generating processes; and on-site waste disposal practices. The description shall specifically list any significant potential source of pollutants at the site and for each potential source, any pollutant or pollutant parameter (e.g., biochemical oxygen demand, etc.) of concern shall be identified.

3. Measures and controls. Each facility covered by this permit shall develop a description of storm water management controls appropriate for the facility, and implement such controls. The appropriateness and priorities of controls in a plan shall reflect identified potential sources of pollutants at the facility. The description of storm water management controls shall address the following minimum components, including a schedule for implementing such controls:

a. Good housekeeping. Good housekeeping requires the maintenance of areas which may contribute pollutants to storm water discharges in a clean, orderly manner. The plan shall describe procedures performed to minimize contact of materials with storm water run-off. Particular attention should be paid to areas where raw materials are stockpiled, material handling areas, storage areas, liquid storage tanks, and loading/unloading areas.

b. Preventive maintenance. A preventive maintenance program shall involve timely inspection and maintenance of storm water management devices (e.g., cleaning oil/water separators, catch basins) as well as inspecting and testing facility equipment and systems to uncover conditions that could cause breakdowns or failures resulting in discharges of pollutants to surface waters, and ensuring appropriate maintenance of such equipment and systems. The maintenance program shall require periodic removal of debris from discharge diversions and conveyance systems. Permittees using settling basins to control their effluents must provide maintenance schedules for such basins in the pollution prevention plan.

c. Spill prevention and response procedures. Areas where potential spills which can contribute pollutants to storm water discharges can occur, and their accompanying drainage points shall be identified clearly in the storm water pollution prevention plan. Where appropriate, specifying material handling procedures, storage requirements, and use of equipment such as diversion valves in the plan should be considered. Procedures for cleaning up spills shall be identified in the plan and made available to the appropriate personnel. The necessary equipment to implement a clean up should be available to personnel.

d. Inspections. Facility personnel who are familiar with the mining activity, the best management practices and the storm water pollution prevention plan shall be identified to inspect material storage and handling areas, liquid storage tanks, hoppers or silos, vehicle and equipment maintenance areas, cleaning and fueling areas, material handling vehicles and designated equipment and processing areas of the facility; to inspect best management practices; and to conduct visual examinations of storm water associated with industrial activity. The inspection frequency shall be specified in the plan based upon a consideration of the level of industrial activity at the facility, but shall be a minimum of quarterly. Inspections of best management practices shall include inspection of storm water discharge diversions, conveyance systems, sediment control and collection systems, containment structures, vegetation, serrated slopes, and benched slopes to determine their effectiveness, the integrity of control structures, if soil erosion has occurred, or if there is evidence of actual or potential discharge of contaminated storm water. Visual examinations of storm water discharges associated with industrial activity shall include examination of storm water samples representative of storm event discharges from the facility and observation of color, odor, clarity, floating solids, settled solids, suspended solids, foam, oil sheen, and other obvious indicators of storm water pollution. Site inspection, best management practices inspection and visual examination results must be documented and maintained on-site with the facility pollution prevention plan. Documentation for visual examinations of storm water shall include the examination date and time, examination personnel, outfall location, the nature of the discharge, visual quality of the storm water discharge and probable sources of any observed storm water contamination. Part II B regarding representative discharges and Part II C regarding sampling waivers shall apply to the taking of samples for visual examination except that (i) the documentation required by these sections shall be retained with the storm water pollution prevention plan visual examination records rather than submitted to the department, and (ii) substitute sampling for waivered sampling is not required if the proper documentation is maintained. A set of tracking or followup procedures shall be used to ensure that appropriate actions are taken in response to the inspections.

e. Employee training. Employee training programs shall inform personnel responsible for implementing activities identified in the storm water pollution prevention plan or otherwise responsible for storm water management at all levels of responsibility of the components and goals of the storm water pollution prevention plan. Training should address topics such as spill response, good housekeeping and material management practices. A pollution prevention plan shall identify periodic dates for such training.

f. Recordkeeping and internal reporting procedures. A description of incidents such as spills, or other discharges, along with other information describing the quality and quantity of storm water discharges shall be included in the plan required under this part. Inspections and maintenance activities shall be documented and records of such activities shall be incorporated into the plan. Ineffective best management practices must be recorded and the date of their corrective action noted.

g. Sediment and erosion control. The plan shall identify areas which, due to topography, activities, or other factors, have a high potential for significant soil erosion, and identify structural, vegetative, or stabilization measures to be used to limit erosion. Permittees must indicate the location and design for proposed best management practices to be implemented prior to land disturbance activities. For sites already disturbed but without best management practices, the permittee must indicate the location and design of best management practices that will be implemented. The permittee is required to indicate plans for grading, contouring, stabilization, and establishment of vegetative cover for all disturbed areas, including road banks.

h. Management of run-off. The plan shall contain a narrative consideration of the appropriateness of traditional storm water management practices (practices other than those which control the generation or sources of pollutants) used to divert, infiltrate, reuse, or otherwise manage storm water run-off in a manner that reduces pollutants in storm water discharges from the site. The plan shall provide that measures that the permittee determines to be reasonable and appropriate shall be implemented and maintained. The potential of various sources at the facility to contribute pollutants to storm water discharges associated with industrial activity (see Part II H 2 (description of potential pollutant sources) of this permit) shall be considered when determining reasonable and appropriate measures. Appropriate measures may include: vegetative swales and practices, reuse of collected storm water (such as for a process or as an irrigation source), inlet controls (such as oil/water separators), snow management activities, infiltration devices, and wet detention/retention devices.

4. Comprehensive site compliance evaluation. Facility personnel who are familiar with the mining activity, the best management practices and the storm water pollution prevention plan shall conduct site compliance evaluations at appropriate intervals specified in the plan, but in no case less than once a year for active sites. When annual compliance evaluations are shown in the plan to be impractical for inactive mining sites due to remote location and inaccessibility, site evaluations must be conducted at least once every three years. Such evaluations shall include the following:

a. Areas contributing to a storm water discharge associated with industrial activity, including material storage and handling areas; liquid storage tanks; hoppers or silos; vehicle and equipment maintenance, cleaning, and fueling areas; material handling vehicles; equipment and processing areas; and areas where aggregate is stockpiled outdoors, shall be visually inspected for evidence of, or the potential for, pollutants entering the drainage system. Measures to reduce pollutant loadings shall be evaluated to determine whether they are adequate and properly implemented in accordance with the terms of the permit or whether additional control measures are needed. Structural storm water management measures, sediment and erosion control measures, and other structural pollution prevention measures identified in the plan shall be observed to ensure that they are operating correctly. A visual inspection of equipment needed to implement the plan, such as spill response equipment, shall be made.

b. Based on the results of the evaluation, the description of potential pollutant sources identified in the plan in accordance with Part II H 2 (description of potential pollutant sources) of this permit and pollution prevention measures and controls identified in the plan in accordance with Part II H 3 (measures and controls) of this permit shall be revised as appropriate within 14 days of such inspection and shall provide for implementation of any changes to the plan in a timely manner, but in no case more than 90 days after the inspection.

c. A report summarizing the scope of the inspection, personnel making the inspection, the dates of the inspection, major observations relating to the implementation of the storm water pollution prevention plan, and actions taken in accordance with Part II H 4 b of this permit shall be made and retained as required in Part III B (records). The report shall identify any incidents of noncompliance. Where a report does not identify any incidents of noncompliance, the report shall contain a certification that the facility is in compliance with the storm water pollution prevention plan and this permit. The report shall be signed in accordance with Part III K (signatory requirements) of this permit and retained as required in Part III B.

d. Where compliance evaluation schedules overlap with inspections required under Part II H 3 d (inspections), the compliance evaluation may be conducted in place of one such inspection.

5. Additional requirements for storm water discharges associated with industrial activity that discharge into or through municipal separate storm sewer systems serving a population of 100,000 or more.

a. In addition to the applicable requirements of this permit, facilities covered by this permit must comply with applicable requirements in municipal storm water management programs developed under VPDES permits issued for the discharge of the municipal separate storm sewer system that receives the facility's discharge, provided the permittee has been notified of such conditions.

b. Permittees that discharge storm water associated with industrial activity through a municipal separate storm sewer system serving a population of 100,000 or more, or a municipal system designated by the director, shall make plans available to the municipal operator of the system upon request.

Part III
Conditions Applicable To All VPDES Permits

A. Monitoring.

1. Samples and measurements taken as required by this permit shall be representative of the monitored activity.

2. Monitoring shall be conducted according to procedures approved under 40 CFR Part 136 or alternative methods approved by the U.S. Environmental Protection Agency, unless other procedures have been specified in this permit.

3. The permittee shall periodically calibrate and perform maintenance procedures on all monitoring and analytical instrumentation at intervals that will ensure accuracy of measurements.

B. Records.

1. Records of monitoring information shall include:

a. The date, exact place, and time of sampling or measurements;

b. The individual(s) who performed the sampling or measurements;

c. The date(s) and time(s) analyses were performed;

d. The individual(s) who performed the analyses;

e. The analytical techniques or methods used; and

f. The results of such analyses.

2. Except for records of monitoring information required by this permit related to the permittee's sewage sludge use and disposal activities, which shall be retained for a period of at least five years, the permittee shall retain records of all monitoring information, including all calibration and maintenance records and all original strip chart recordings for continuous monitoring instrumentation, copies of all reports required by this permit, and records of all data used to complete the registration statement for this permit, for a period of at least three years from the date of the sample, measurement, report or request for coverage. This period of retention shall be extended automatically during the course of any unresolved litigation regarding the regulated activity or regarding control standards applicable to the permittee, or as requested by the board.

C. Reporting monitoring results.

1. The permittee shall submit the results of the monitoring required by this permit not later than the 10th day of the month after monitoring takes place, unless another reporting schedule is specified elsewhere in this permit. Monitoring results shall be submitted to the department's regional office.

2. Monitoring results shall be reported on a Discharge Monitoring Report (DMR) or on forms provided, approved or specified by the department.

3. If the permittee monitors any pollutant specifically addressed by this permit more frequently than required by this permit using test procedures approved under 40 CFR Part 136 or using other test procedures approved by the U.S. Environmental Protection Agency or using procedures specified in this permit, the results of this monitoring shall be included in the calculation and reporting of the data submitted in the DMR or reporting form specified by the department.

4. Calculations for all limitations which require averaging of measurements shall utilize an arithmetic mean unless otherwise specified in this permit.

D. Duty to provide information. The permittee shall furnish to the department, within a reasonable time, any information which the board may request to determine whether cause exists for modifying, revoking and reissuing, or terminating this permit or to determine compliance with this permit. The board may require the permittee to furnish, upon request, such plans, specifications, and other pertinent information as may be necessary to determine the effect of the wastes from his discharge on the quality of state waters, or such other information as may be necessary to accomplish the purposes of the State Water Control Law. The permittee shall also furnish to the department, upon request, copies of records required to be kept by this permit.

E. Compliance schedule reports. Reports of compliance or noncompliance with, or any progress reports on, interim and final requirements contained in any compliance schedule of this permit shall be submitted no later than 14 days following each schedule date.

F. Unauthorized discharges. Except in compliance with this permit or another permit issued by the board, it shall be unlawful for any person to:

1. Discharge into state waters sewage, industrial wastes, other wastes, or any noxious or deleterious substances; or

2. Otherwise alter the physical, chemical or biological properties of such state waters and make them detrimental to the public health, or to animal or aquatic life, or to the use of such waters for domestic or industrial consumption, or for recreation, or for other uses.

G. Reports of unauthorized discharges. Any permittee who discharges or causes or allows a discharge of sewage, industrial waste, other wastes or any noxious or deleterious substance into or upon state waters in violation of Part III F (unauthorized discharges); or who discharges or causes or allows a discharge that may reasonably be expected to enter state waters in violation of Part III F, shall notify the department of the discharge immediately upon discovery of the discharge, but in no case later than 24 hours after said discovery. A written report of the unauthorized discharge shall be submitted to the department within five days of discovery of the discharge. The written report shall contain:

1. A description of the nature and location of the discharge;

2. The cause of the discharge;

3. The date on which the discharge occurred;

4. The length of time that the discharge continued;

5. The volume of the discharge;

6. If the discharge is continuing, how long it is expected to continue;

7. If the discharge is continuing, what the expected total volume of the discharge will be; and

8. Any steps planned or taken to reduce, eliminate and prevent a recurrence of the present discharge or any future discharges not authorized by this permit.

Discharges reportable to the department under the immediate reporting requirements of other regulations are exempted from this requirement.

H. Reports of unusual or extraordinary discharges. If any unusual or extraordinary discharge including a bypass or upset should occur from a treatment works and the discharge enters or could be expected to enter state waters, the permittee shall promptly notify, in no case later than 24 hours, the department by telephone after the discovery of the discharge. This notification shall provide all available details of the incident, including any adverse affects on aquatic life and the known number of fish killed. The permittee shall reduce the report to writing and shall submit it to the department within five days of discovery of the discharge in accordance with Part III I 2. Unusual and extraordinary discharges include but are not limited to any discharge resulting from:

1. Unusual spillage of materials resulting directly or indirectly from processing operations;

2. Breakdown of processing or accessory equipment;

3. Failure or taking out of service some or all of the treatment works; and

4. Flooding or other acts of nature.

I. Reports of noncompliance. The permittee shall report any noncompliance which may adversely affect state waters or may endanger public health.

1. An oral report shall be provided within 24 hours from the time the permittee becomes aware of the circumstances. The following shall be included as information which shall be reported within 24 hours under this subdivision:

a. Any unanticipated bypass; and

b. Any upset which causes a discharge to surface waters.

2. A written report shall be submitted within five days and shall contain:

a. A description of the noncompliance and its cause;

b. The period of noncompliance, including exact dates and times, and if the noncompliance has not been corrected, the anticipated time it is expected to continue; and

c. Steps taken or planned to reduce, eliminate, and prevent reoccurrence of the noncompliance.

The board may waive the written report on a case-by-case basis for reports of noncompliance under Part III I if the oral report has been received within 24 hours and no adverse impact on state waters has been reported.

3. The permittee shall report all instances of noncompliance not reported under Parts III I 1 or 2, in writing, at the time the next monitoring reports are submitted. The reports shall contain the information listed in Part III I 2.

NOTE: The immediate (within 24 hours) reports required in Parts III G, H and I may be made to the department's regional office. Reports may be made by telephone or by fax. For reports outside normal working hours, leave a message and this shall fulfill the immediate reporting requirement. For emergencies, the Virginia Department of Emergency Services maintains a 24-hour telephone service at 1-800-468-8892.

J. Notice of planned changes.

1. The permittee shall give notice to the department as soon as possible of any planned physical alterations or additions to the permitted facility. Notice is required only when:

a. The permittee plans alteration or addition to any building, structure, facility, or installation from which there is or may be a discharge of pollutants, the construction of which commenced:

(1) After promulgation of standards of performance under § 306 of the federal Clean Water Act which are applicable to such source; or

(2) After proposal of standards of performance in accordance with § 306 of the federal Clean Water Act which are applicable to such source, but only if the standards are promulgated in accordance with § 306 within 120 days of their proposal;

b. The alteration or addition could significantly change the nature or increase the quantity of pollutants discharged. This notification applies to pollutants which are subject neither to effluent limitations nor to notification requirements specified elsewhere in this permit; or

c. The alteration or addition results in a significant change in the permittee's sludge use or disposal practices and such alteration, addition, or change may justify the application of permit conditions that are different from or absent in the existing permit, including notification of additional use or disposal sites not reported during the permit application process or not reported pursuant to an approved land application plan.

2. The permittee shall give advance notice to the department of any planned changes in the permitted facility or activity which may result in noncompliance with permit requirements.

K. Signatory requirements.

1. Registration statement. All registration statements shall be signed as follows:

a. For a corporation: by a responsible corporate officer. For the purposes of this section, a responsible corporate officer means: (i) a president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy- or decision-making functions for the corporation, or (ii) the manager of one or more manufacturing, production, or operating facilities provided the manager is authorized to make management decisions that govern the operation of the regulated facility including having the explicit or implicit duty of making capital investment recommendations, and initiating and directing other comprehensive measures to assure long-term environmental compliance with environmental laws and regulations; the manager can ensure that the necessary systems are established or actions taken to gather complete and accurate information for permit application requirements; and where authority to sign documents has been assigned or delegated to the manager in accordance with corporate procedures;

b. For a partnership or sole proprietorship: by a general partner or the proprietor, respectively; or

c. For a municipality, state, federal, or other public agency: by either a principal executive officer or ranking elected official. For purposes of this section, a principal executive officer of a public agency includes: (i) the chief executive officer of the agency or (ii) a senior executive officer having responsibility for the overall operations of a principal geographic unit of the agency.

2. Reports, etc. All reports required by permits, and other information requested by the board, shall be signed by a person described in Part III K 1 or by a duly authorized representative of that person. A person is a duly authorized representative only if:

a. The authorization is made in writing by a person described in Part III K 1;

b. The authorization specifies either an individual or a position having responsibility for the overall operation of the regulated facility or activity such as the position of plant manager, operator of a well or a well field, superintendent, position of equivalent responsibility, or an individual or position having overall responsibility for environmental matters for the company. A duly authorized representative may thus be either a named individual or any individual occupying a named position; and

c. The written authorization is submitted to the department.

3. Changes to authorization. If an authorization under Part III K 2 is no longer accurate because a different individual or position has responsibility for the overall operation of the facility, a new authorization satisfying the requirements of Part III K 2 shall be submitted to the department prior to or together with any reports or information to be signed by an authorized representative.

4. Certification. Any person signing a document under Parts III K 1 or 2 shall make the following certification:

"I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the information, the information submitted is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations."

L. Duty to comply. The permittee shall comply with all conditions of this permit. Any permit noncompliance constitutes a violation of the State Water Control Law and the federal Clean Water Act, except that noncompliance with certain provisions of this permit may constitute a violation of the State Water Control Law but not the federal Clean Water Act. Permit noncompliance is grounds for enforcement action; for permit termination, revocation and reissuance, or modification; or denial of a permit renewal application.

The permittee shall comply with effluent standards or prohibitions established under § 307(a) of the federal Clean Water Act for toxic pollutants and with standards for sewage sludge use or disposal established under § 405(d) of the federal Clean Water Act within the time provided in the regulations that establish these standards or prohibitions or standards for sewage sludge use or disposal, even if this permit has not yet been modified to incorporate the requirement.

M. Duty to reapply. If the permittee wishes to continue an activity regulated by this permit after the expiration date of this permit, the permittee shall submit a new registration statement at least 180 days before the expiration date of the existing permit, unless permission for a later date has been granted by the board. The board shall not grant permission for registration statements to be submitted later than the expiration date of the existing permit.

N. Effect of a permit. This permit does not convey any property rights in either real or personal property or any exclusive privileges, nor does it authorize any injury to private property or invasion of personal rights or any infringement of federal, state or local laws or regulations.

O. State law. Nothing in this permit shall be construed to preclude the institution of any legal action under, or relieve the permittee from any responsibilities, liabilities, or penalties established pursuant to, any other state law or regulation or under authority preserved by § 510 of the federal Clean Water Act. Except as provided in permit conditions on "bypass" (Part III U) and "upset" (Part III V), nothing in this permit shall be construed to relieve the permittee from civil and criminal penalties for noncompliance.

P. Oil and hazardous substance liability. Nothing in this permit shall be construed to preclude the institution of any legal action or relieve the permittee from any responsibilities, liabilities, or penalties to which the permittee is or may be subject under §§ 62.1-44.34:14 through 62.1-44.34:23 of the State Water Control Law.

Q. Proper operation and maintenance. The permittee shall at all times properly operate and maintain all facilities and systems of treatment and control (and related appurtenances) which are installed or used by the permittee to achieve compliance with the conditions of this permit. Proper operation and maintenance also includes effective plant performance, adequate funding, adequate staffing, and adequate laboratory and process controls, including appropriate quality assurance procedures. This provision requires the operation of back-up or auxiliary facilities or similar systems which are installed by the permittee only when the operation is necessary to achieve compliance with the conditions of this permit.

R. Disposal of solids or sludges. Solids, sludges or other pollutants removed in the course of treatment or management of pollutants shall be disposed of in a manner so as to prevent any pollutant from such materials from entering state waters.

S. Duty to mitigate. The permittee shall take all reasonable steps to minimize or prevent any discharge or sludge use or disposal in violation of this permit which has a reasonable likelihood of adversely affecting human health or the environment.

T. Need to halt or reduce activity not a defense. It shall not be a defense for a permittee in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to maintain compliance with the conditions of this permit.

U. Bypass.

1. "Bypass" means the intentional diversion of waste streams from any portion of a treatment facility. The permittee may allow any bypass to occur which does not cause effluent limitations to be exceeded, but only if it also is for essential maintenance to ensure efficient operation. These bypasses are not subject to the provisions of Parts III U 2 and U 3.

2. Notice.

a. Anticipated bypass. If the permittee knows in advance of the need for a bypass, prior notice shall be submitted if possible at least 10 days before the date of the bypass.

b. Unanticipated bypass. The permittee shall submit notice of an unanticipated bypass as required in Part III I (reports of noncompliance).

3. Prohibition of bypass.

a. Bypass is prohibited, and the board may take enforcement action against a permittee for bypass, unless:

(1) Bypass was unavoidable to prevent loss of life, personal injury, or severe property damage;

(2) There were no feasible alternatives to the bypass, such as the use of auxiliary treatment facilities, retention of untreated wastes, or maintenance during normal periods of equipment downtime. This condition is not satisfied if adequate back-up equipment should have been installed in the exercise of reasonable engineering judgment to prevent a bypass which occurred during normal periods of equipment downtime or preventive maintenance; and

(3) The permittee submitted notices as required under Part III U 2.

b. The board may approve an anticipated bypass, after considering its adverse effects, if the board determines that it will meet the three conditions listed in Part III U 3 a.

V. Upset.

1. An upset constitutes an affirmative defense to an action brought for noncompliance with technology-based permit effluent limitations if the requirements of Part III V 2 are met. A determination made during administrative review of claims that noncompliance was caused by upset, and before an action for noncompliance, is not a final administrative action subject to judicial review.

2. A permittee who wishes to establish the affirmative defense of upset shall demonstrate, through properly signed, contemporaneous operating logs or other relevant evidence that:

a. An upset occurred and that the permittee can identify the cause(s) of the upset;

b. The permitted facility was at the time being properly operated;

c. The permittee submitted notice of the upset as required in Part III I; and

d. The permittee complied with any remedial measures required under Part III S.

3. In any enforcement proceeding, the permittee seeking to establish the occurrence of an upset has the burden of proof.

W. Inspection and entry. The permittee shall allow the director or an authorized representative, upon presentation of credentials and other documents as may be required by law, to:

1. Enter upon the permittee's premises where a regulated facility or activity is located or conducted or where records must be kept under the conditions of this permit;

2. Have access to and copy, at reasonable times, any records that must be kept under the conditions of this permit;

3. Inspect at reasonable times any facilities, equipment (including monitoring and control equipment), practices, or operations regulated or required under this permit; and

4. Sample or monitor at reasonable times, for the purposes of ensuring permit compliance or as otherwise authorized by the federal Clean Water Act and the State Water Control Law, any substances or parameters at any location.

For purposes of this section, the time for inspection shall be deemed reasonable during regular business hours and whenever the facility is discharging. Nothing contained herein shall make an inspection unreasonable during an emergency.

X. Permit actions. Permits may be modified, revoked and reissued, or terminated for cause. The filing of a request by the permittee for a permit modification, revocation and reissuance, or termination, or a notification of planned changes or anticipated noncompliance does not stay any permit condition.

Y. Transfer of permits.

1. Permits are not transferable to any person except after notice to the department. Except as provided in Part III Y 2, a permit may be transferred by the permittee to a new owner or operator only if the permit has been modified or revoked and reissued, or a minor modification made, to identify the new permittee and incorporate such other requirements as may be necessary under the State Water Control Law and the federal Clean Water Act.

2. As an alternative to transfers under Part III Y 1, this permit may be automatically transferred to a new permittee if:

a. The current permittee notifies the department at least 30 days in advance of the proposed transfer of the title to the facility or property;

b. The notice includes a written agreement between the existing and new permittees containing a specific date for transfer of permit responsibility, coverage, and liability between them; and

c. The board does not notify the existing permittee and the proposed new permittee of its intent to modify or revoke and reissue the permit. If this notice is not received, the transfer is effective on the date specified in the agreement mentioned in Part III Y 2 b.

Z. Severability. The provisions of this permit are severable, and if any provision of this permit or the application of any provision of this permit to any circumstance is held invalid, the application of such provision to other circumstances and the remainder of this permit shall not be affected thereby.

FORMS (9VAC25-190)

Department of Environmental Quality Water Division Permit Application Fee (rev. 6/99) 1/08).

Local Government Ordinance Form (eff. 8/93).

Virginia Pollutant Discharge Elimination System General Permit Registration Statement - Nonmetallic Mineral Mining.

Virginia Pollutant Discharge Elimination System General Permit Notice of Termination for Nonmetallic Mineral Mining.

A. The minimum service volume of a mobile unit shall be prorated on a site-by-site basis reflecting the amount of time that proposed mobile units will be used, and existing mobile units have been used, during the relevant reporting period, at each site using the following formula:

Required full-time minimum service volume

X

Number of days the service will be on site each week

X 0.2 =

Prorated minimum services volume (not to exceed the required full-time minimum service volume) ]

B. [ This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the service has been achieved as described in the applicable service section The average annual utilization of existing and approved CT, MRI, PET, lithotripsy, and catheterization services in a health planning district shall be calculated for such services as follows:

(

Total volume of all units of the relevant service in the reporting period

)

X

100

=

% Average Utilization

(

# of existing or approved fixed units

X

Fixed unit minimum service volume

)

+

Y Utilization

Y = the sum of the minimum service volume of each mobile site in the health planning district with the minimum services volume for each such site prorated according to subsection A of this section.

C. This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the services has been achieved as described in the applicable service section. ]

D. Applicants shall not use this section to justify a need to establish new services.

12VAC5-230-80. Institutional need When institutional expansion needed.

A. Notwithstanding any other provisions of this chapter, consideration will be given to the commissioner may grant approval for the expansion of services at an existing medical care facilities facility in a [ health ] planning districts district with an excess supply of such services when the proposed expansion can be justified on the basis of facility-specific utilization a facility's need having exceeded its current service capacity to provide such service or on the geographic remoteness of the facility.

B. If a facility with an institutional need to expand is part of a network health system, the underutilized services at other facilities within the network should be relocated health system should be reallocated, when appropriate, to the facility within the planning district with the institutional need when possible to expand before additional services are approved for the applicant. However, underutilized services located at a health system's geographically remote facility may be disregarded when determining institutional need for the proposed project.

C. This section is not applicable to nursing facilities pursuant to § 32.1-102.3:2 of the Code of Virginia.

12VAC5-230-90. Compliance with the terms of a condition.

A. The commissioner may condition the approval of a COPN to provide care to Virginia's indigent population, patients with specialized needs, or the medically underserved.

B. The applicant shall actively seek to provide opportunities to offer the conditioned service directly to indigent or uninsured persons at a reduced rate or free of charge to patients with specialized needs, or by the facilitation of primary care services in designated medically underserved areas.

C. If the direct provision of the conditioned services does not fulfill the terms of the condition, the center may determine the applicant to be in compliance with the terms of the condition when:

1. The applicant is part of a facility or provider network and the facility or provider network has provided reduced rate or uncompensated care at or above the regional standard; or

2. The applicant provides direct financial support for community based health care services at a value equal to or greater than the difference between the terms of the condition and the amount of direct care provided.

Such direct financial support shall be in addition to, and not a substitute for, other charitable giving chosen by the applicant.

D. Acceptable proof for direct financial support is a signed receipt indicating the number or amount of services or other support provided and dollar value of that service or support. Applicants providing direct financial support for community based health care services should render that support through one of the following organizations:

1. The Virginia Association of Free Clinics;

2. The Virginia Health Care Foundation; or

3. The Virginia Primary Care Association.

E. Applicants shall demonstrate compliance with the terms of a condition for the previous 12-month period. The written condition report shall be certified or affirmed by the applicants and filed with the center. Such report shall include, but is not limited to, the:

1. Facility or service name and address;

2. Certificate number;

3. Facility or service gross patient revenues;

4. Dollar value of the charity care provided, excluding bad debts and disallowances from payers; and

5. Number of individuals served by the direct provision of care or a receipt from one of the allowable organizations listed in subsection D of this section.

Part II
Diagnostic Imaging Services

Article 1
Criteria and Standards for Computed Tomography

12VAC5-230-100. Accessibility 12VAC5-230-90. Travel time.

CT services should be within 30 minutes driving time one way, under normal conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

12VAC5-230-110 12VAC5-230-100. Need for new fixed site [ or mobile ] service.

A. No CT service should be approved at a location that is within 30 minutes driving time one way of:

1. A service that is not yet operational; or

2. An existing CT unit that has performed fewer than 3,000 scans during the relevant reporting period.

B. A. No new fixed site [ or mobile ] CT service or network shall should be approved unless all existing fixed site CT services or networks in the [ health ] planning district performed an average of 4,500 CT scans per machine during the relevant reporting period. [ 10,000 7,400 ] procedures per existing and approved CT scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing [ fixed site ] providers in the [ health ] planning district [ below 10,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of CT scanners in such [ health ] planning district.

C. Consideration may be given to new CT services proposed for sites located beyond 30 minutes driving time one way of existing facilities that do not meet the 4,500 scans per machine criterion if the proposed sites are in rural areas B. [ Existing ] CT scanners [ to be ] used solely for simulation with radiation therapy treatment shall be exempt from [ the utilization criteria of ] this article [ when applying for a COPN. In addition, existing CT scanners used solely for simulation with radiation therapy treatment may be disregarded in computing the average utilization of CT scanners in such health planning district ].

12VAC5-230-120 12VAC5-230-110. Expansion of existing fixed site service.

Proposals to increase the number of CT scanners in expand an existing medical care facility's CT service or network may through the addition of a CT scanner should be approved only if when the existing service or network services performed an average of 3,000 CT scans [ 10,000 7,400 ] procedures per scanner for the relevant reporting period. The commissioner may authorize placement of a new unit at the applicant's existing medical care facility or at a separate location within the applicant's primary service area for CT services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the [ health ] planning district [ below 10,000 procedures ].

12VAC5-230-120. Adding or expanding mobile CT services.

A. Proposals for mobile CT scanners shall demonstrate that, for the relevant reporting period, at least 4,800 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing CT providers in the [ health ] planning district [ below 10,000 procedures for fixed site scanners or 4,800 procedures for mobile scanners ].

B. Proposals to convert [ authorized ] mobile CT scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, at least 6,000 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing CT providers in the [ health ] planning district [ below 10,000 procedures for fixed site scanners or 4,800 procedures for mobile scanners ].

12VAC5-230-130. Staffing.

Providers of CT services should be under the direct supervision of one or more board-certified diagnostic radiologists direction or supervision of one or more qualified physicians.

12VAC5-230-140. Space.

Applicants shall provide documentation that:

1. A suitable environment will be provided for the proposed CT services, including protection against known hazards; and

2. Space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

Article 2
Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-150. Accessibility. 12VAC5-230-140. Travel time.

MRI services should be within 30 minutes driving time one way, under normal conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Article 2
Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-160 12VAC5-230-150. Need for new fixed site service.

A. No new fixed site MRI services shall should be approved unless all existing fixed site MRI services in the [ health ] planning district performed an average of 4,000 scans per machine 5,000 procedures per existing and approved fixed site MRI scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site MRI providers in the [ health ] planning district [ below 5,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of MRI scanners in such [ health ] planning district.

B. Consideration may be given to new MRI services proposed for sites located beyond 30 minutes driving time one way of existing facilities that do not meet the 4,000 scans per machine criterion of the prospered sites are in rural areas.

12VAC5-230-170 12VAC5-230-160. Expansion of services fixed site service.

Proposals to expand an existing medical care facility's MRI services through the addition of a new scanning unit of an MRI scanner may be approved if when the existing service performed at least 4,000 scans an average of 5,000 MRI procedures per existing unit scanner during the relevant reporting period. The commissioner may authorize placement of the new unit at the applicant's existing medical care facility, or at a separate location within the applicant's primary service area for MRI services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the [ health ] planning district [ below 5,000 procedures ].

12VAC5-230-170. Adding or expanding mobile MRI services.

A. Proposals for mobile MRI scanners shall demonstrate that, for the relevant reporting period, at least 2,400 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing MRI providers in the [ health ] planning district [ below 2,400 procedures for mobile scanners ].

B. Proposals to convert [ authorized ] mobile MRI scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, 3,000 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing MRI providers in the [ health ] planning district [ below 5,000 procedures for fixed site scanners and 2,400 procedures for mobile scanners ].

12VAC5-230-180. Staffing.

MRI machines services should be under the direct, on-site supervision of one or more board-certified diagnostic radiologists direct supervision of one or more qualified physicians.

12VAC5-230-190. Space.

Applicants should provide documentation that:

1. A suitable environment will be provided for the proposed MRI services, including shielding and protection against known hazards; and

2. Space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

Article 3
Magnetic Source Imaging

12VAC5-230-200 12VAC5-230-190. Policy for the development of MSI services.

Because Magnetic Source Imaging (MSI) scanning systems are still in the clinical research stage of development with no third-party payment available for clinical applications, and because it is uncertain as to how rapidly this technology will reach a point where it is shown to be clinically suitable for widespread use and distribution on a cost-effective basis, it is preferred that the entry and development of this technology in Virginia should initially occur at or in affiliation with, the academic medical centers in the state.

Article 4
Positron Emission Tomography

12VAC5-230-210 12VAC5-230-200. Accessibility Travel time.

The service area for each proposed PET service shall be an entire planning district PET services should be within 60 minutes driving time one way under normal conditions of 95% of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Article 4
Positron Emission Tomography

12VAC5-230-220 12VAC5-230-210. Need for new fixed site service.

A. Whether the applicant is a consortium of hospitals, a hospital network, or a single general hospital, at least 850 new PET appropriate cases should have been diagnosed in the planning district. If the applicant is a hospital, whether free-standing or within a hospital system, 850 new PET appropriate cases shall have been diagnosed and the hospital shall have provided radiation therapy services with specific ancillary services suitable for the equipment before a new fixed site PET service should be approved for the [ health ] planning district.

B. If the applicant is a general hospital, the facility shall provide radiation therapy services and specific ancillary services suitable for the equipment, and have reported at least 500 new courses of treatment or at least 8,000 treatment visits in the most recent reporting period No new fixed site PET services should be approved unless an average of 6,000 procedures [ preexisting per existing ] and approved fixed site PET scanner were performed in the [ health ] planning district during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site PET providers in the [ health ] planning district [ below 6,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of PET units in such [ panning health planning ] district.

Note: For the purposes of tracking volume utilization, an image taken with a PET/CT scanner that takes concurrent PET/CT images shall be counted as one PET procedure. Images made with PET/CT scanners that can take PET or CT images independently shall be counted as individual PET procedures and CT procedures respectively, unless those images are made concurrently.

C. If the applicant is a consortium of general hospitals or a hospital network, at least one of the consortium or network members shall provide radiation therapy services and specific ancillary services suitable for the equipment, and have reported at least 500 new PET appropriate patients.

D. Future applications of PET equipment shall be evaluated based on review of national literature.

12VAC5-230-230. Additional scanners. 12VAC5-230-220. Expansion of fixed site services.

No additional PET scanners shall be added in a planning district unless the applicant can demonstrate that the utilization of the existing PET service was at least 1,200 PET scans for a fixed site unit and that the proposed new or expanded service would not reduce the utilization after for existing services below 850 PET scans for a fixed site unit. The applicant shall also provide documentation that he project complies with 12VAC50-230-240. Proposals to increase the number of PET scanners in an existing PET service should be approved only when the existing scanners performed an average of 6,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing fixed site providers in the [ health ] planning district [ below 6,000 procedures ].

12VAC5-230-230. Adding or expanding mobile PET or PET/CT services.

A. Proposals for mobile PET or PET/CT scanners [ shall should ] demonstrate that, for the relevant reporting period, at least 230 [ procedures were performed PET or PET/CT appropriate patients were seen ] and that the proposed mobile unit will not significantly reduce the utilization of existing providers in the [ health ] planning district [ below 6,000 procedures for the fixed site PET providers or 230 procedures for the mobile PET providers ].

B. Proposals to convert [ authorized ] mobile PET or PET/CT scanners to fixed site scanners should demonstrate that, for the relevant reporting period, at least 1,400 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing providers in the [ health ] planning district [ below 6,000 procedures for the fixed site PET or 230 procedures of the mobile PET providers ].

12VAC5-230-240. Staffing.

PET services should be under the direction of a physician who is a board certified radiologist or supervision of one or more qualified physicians. Such physician physicians shall be a designated [ or ] authorized user [ users of isotopes used for PET ] by the Nuclear Regulatory Commission or licensed by the Office Division of Radiologic Health of the Virginia Department of Health, as applicable.

Article 5
Noncardiac Nuclear Imaging Criteria and Standards

12VAC5-230-250. Accessibility Travel time.

Noncardiac nuclear imaging services should be available within 30 minutes driving time one way, under normal driving conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

12VAC5-230-260. Introduction of a service Need for new service.

Any applicant proposing to establish a medical care facility for the provision of noncardiac nuclear imaging, or introducing nuclear imaging as a new service at an existing medical care facility, shall provide documentation that No new noncardiac imaging services should be approved unless the service can achieve a minimum utilization level of:

(i) 650 scans 1. 650 procedures in the first 12 months of operation, ;

(ii) 1,000 scans 2. 1,000 procedures in the second 12 months of services, and (iii) 1,250 scans service in the second 12 months of operation service; and

3. The proposed new service would not significantly reduce the utilization of existing providers in the [ health ] planning district.

Note: The utilization of an existing service operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of noncardiac nuclear imaging services in such [ health ] planning district.

12VAC5-230-270. Staffing.

The proposed new or expanded noncardiac nuclear imaging service shall should be under the direction of a board certified physician or supervision of one or more qualified physicians a designated [ or ] authorized user [ users of isotopes licensed ] by the Nuclear Regulatory Commission or the Office Division of Radiologic Health of the Virginia Department of Health, as applicable.

Part III
Radiation Therapy Services

Article 1
Radiation Therapy Services

12VAC5-230-280. Accessibility Travel time.

Radiation therapy services should be available within 60 minutes driving time one way, under normal conditions, for of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

12VAC5-230-290. Availability Need for new service.

A. No new radiation therapy service [ shall should ] be approved unless:

(i) existing 1. Existing radiation therapy machines located in the [ health ] planning district were used for at least 320 cancer cases and at least performed an average of 8,000 [ treatment visits procedures per existing and approved radiation therapy machine ] for in the relevant reporting period; and

(ii) it can be reasonably projected that the 2. The new service will perform at least 6,000 5,000 procedures by the third second year of operation without significantly reducing the utilization of existing radiation therapy machines within 60 minutes drive time one way, under normal conditions, such that less than 8,000 procedures will be performed by an existing machine providers in the [ health ] planning district.

B. The number of radiation therapy machines needed in a primary service area [ health ] planning district will be determined as follows:

	Population x Cancer Incidence Rate x 60%
	320

where:

1. The population is projected to be at least 75,000 150,000 people three years from the current year as reported in the most current projections of the Virginia Employment Commission a demographic entity as determined by the commissioner;

2. The "cancer incidence rate" is based on as determined by data from the Statewide Cancer Registry;

3. 60% is the estimated number of new cancer cases in a [ health ] planning district that are treatable with radiation therapy; and

4. 320 is 100% utilization of a radiation therapy machine based upon an anticipated average of 25 [ treatment visits procedures ] per case.

C. Consideration will be given to the approval of Proposals for new radiation therapy services located at a general hospital at least less than 60 minutes driving time one way, under normal conditions, from any site that radiation therapy services are available if the applicant can shall demonstrate that the proposed new services will perform at least an average of 4,500 [ treatment ] procedures annually by the second year of operation, without significantly reducing the utilization of existing machines located within 60 minutes driving time one way, under normal conditions, from the proposed new service location [ providers services ] in the [ health ] planning [ region district ].

D. Proposals for the expansion of radiation therapy services should not be approved unless all existing radiation therapy machines operated by the applicant in the planning district have performed at least 8,000 procedures for the relevant reporting period.

12VAC5-230-300. Statewide Cancer Registry Expansion of service.

Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia

Proposals to [ increase expand ] radiation therapy services should be approved only when all existing radiation therapy [ machines services ] operated by the applicant in the [ health ] planning district have performed an average of 8,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers [ below 8,000 procedures ].

12VAC5-230-310. Staffing Statewide Cancer Registry.

Radiation therapy services shall be under the direction of a physician board-certified in radiation oncology Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

12VAC5-230-320. Equipment, patient care; support services Staffing.

In addition to the radiation therapy machine, the service should have direct access to:

1. Simulation equipment capable of precisely producing the geometric relations of the equipment to be used for treatment of the patient;

2. A computerized treatment planning system;

3. A custom block design and cutting system; and

4. Diagnostic, laboratory oncology services

Radiation therapy services should be under the direction or supervision of one or more qualified physicians [ . Such physicians shall be ] designated [ or ] authorized [ users of isotopes licensed ] by the Nuclear Regulatory Commission or the Division of Radiologic Health of the Virginia Department of Health, as applicable.

Article 2
Criteria and Standards for Stereotactic Radiosurgery

12VAC5-230-330. Availability; need for new service Travel time.

No new services should be approved unless (i) the number of procedures performed with existing units in the planning region average more than 350 per year and (ii) it can be reasonably projected that the proposed new service will perform at least 250 procedures in the second year of operation without reducing patient volumes to existing providers to less than 350 procedures Stereotactic radiosurgery services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of a [ health ] planning [ district region using a mapping software as determined by the commissioner ].

12VAC5-230-340. Statewide Cancer Registry Need for new service.

Facilities shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

A. No new stereotactic radiosurgery services should be approved unless:

1. The number of procedures performed with existing units in the [ health ] planning region averaged more than 350 per year [ in the relevant reporting period ]; and

2. The proposed new service will perform at least 250 procedures in the second year of operation without significantly reducing the utilization of existing providers in the [ health ] planning region [ below 350 treatments ].

B. [ Consideration Preference ] may be given to a [ project that incorporates ] tereotactic radiosurgery service incorporated within an existing standard radiation therapy service using a linear accelerator when an average of 8,000 [ treatments procedures ] during the relevant reporting period [ were performed and the applicant can demonstrate that the volume and cost of the service is justified and utilization of existing services in the health planning region will not be significantly reduced ].

C. [ Consideration Preference ] may be given to a [ project that incorporates a ] dedicated Gamma Knife® [ incorporated ] within an existing radiation therapy service when:

1. At least 350 Gamma Knife® appropriate cases were referred out of the region in the relevant reporting period; and

2. The applicant can demonstrate that:

a. An average of 250 procedures will be preformed in the second year of operation; [ and ]

b. Utilization of existing services in the [ health ] planning region will not be significantly reduced [ below 350 treatments per year; and. ]

[ c. The cost is justified. ]

D. [ Consideration Preference ] may be given to [ a project that incorporates ] non-Gamma Knife® [ SRS ] technology [ incorporated ] within an existing radiation therapy service when:

1. The unit is not part of a linear accelerator;

2. An average of 8,000 radiation [ treatments procedures ] per year were performed by the existing radiation therapy services;

3. At least 250 procedures will be performed within the second year of operation; and

4. Utilization of existing services in the [ health ] planning region will not be significantly reduced [ below 350 treatments ].

12VAC5-230-350. Staffing Expansion of service.

The proposed new or expanded stereotactic radiosurgery services shall be under the direction of a physician who is board-certified in neurosurgery and a radiation oncologist with training in stereotactic radiosurgery

Proposals to increase the number of stereotactic radiosurgery services should be approved only when all existing stereotactic radiosurgery machines in the [ health ] planning region have performed an average of 350 procedures [ per existing and approved unit ] for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers in the [ health ] planning region [ below 350 procedures ].

Part IV
Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-360. Accessibility Statewide Cancer Registry.

Adult cardiac catheterization services should be accessible within 60 minutes driving time one way, under normal conditions, for 95% of the population of the planning district Facilities [ with stereotactic radiosurgery services ] shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

12VAC5-230-370. Availability Staffing.

A. No new fixed site cardiac catheterization laboratory should be approved unless:

1. All existing fixed site cardiac catheterization laboratories located in the planning district were used for at least 960 diagnostic-equivalent cardiac catheterization procedures for the relevant reporting period; and

2. It can be reasonably projected that the proposed new service will perform at least 200 diagnostic equivalent procedures in the first year of operation, 500 diagnostic equivalent procedures in the second year of operation without reducing the utilization of existing laboratories in the planning district to less than 960 diagnostic equivalent procedures at any of those existing laboratories.

B. Proposals for the use of freestanding or mobile cardiac catheterization laboratories shall be approved only if such laboratories will be provided at a site located on the campus of a general or community hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform 200 diagnostic equivalent procedures in the first year of operation, 350 diagnostic equivalent procedures in the second year of operation without reducing the utilization of existing laboratories in the planning district to less than 960 diagnostic equivalent procedures at any of those existing laboratories.

C. Consideration may be given for the approval of new cardiac catheterization services located at a general hospital located 60 minutes or more driving time one way, under normal conditions, from existing laboratories, if it can be projected that the proposed new laboratory will perform at least 200 diagnostic-equivalent procedures in the first year of operation, 400 diagnostic-equivalent procedures in the second year of operation without reducing the utilization of existing laboratories located within 60 minutes driving time one way, under normal conditions, of the proposed new service location.

D. Proposals for the addition of cardiac catheterization laboratories shall not be approved unless all existing cardiac catheterization laboratories operated in the planning district by the applicant have performed at least 1,200 diagnostic-equivalent procedures for the relevant reporting period, and the applicant can demonstrate that the expanded service will achieve a minimum of 200 diagnostic equivalent procedures per laboratory in the first 12 months of operation, 400 diagnostic equivalent procedures in the second 12 months of operation without reducing the utilization of existing cardiac catheterization laboratories in the planning district below 960 diagnostic equivalent procedures.

E. Emergency cardiac catheterization services shall be available within 30 minutes of admission to the facility.

F. No new or expanded pediatric cardiac catheterization services should be approved unless the proposed service will be provided at a hospital that:

1. Provides open heart surgery services, provides pediatric tertiary care services, has a pediatric intensive care unit and provides neonatal special care or has a cardiac intensive care unit and provides pediatric open heart surgery services; and

2. The applicant can demonstrate that each proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation.

G. Applications for new or expanded cardiac catheterization services that include nonemergent interventional cardiology services should not be approved unless emergency open heart surgery services are available within 15 minutes drive time in the hospital where the proposed cardiac catheterization service will be located.

Stereotactic radiosurgery services should be under the direction or supervision of one or more qualified physicians.

Part IV
Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-380. Staffing Travel time.

A. Cardiac catheterization services should have a medical director who is board-certified in cardiology and clinical experience in the performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. All physicians who will be performing cardiac catheterization procedures should be board-certified or board-eligible in cardiology and clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric catheterization services, each physician performing pediatric procedures should be board-certified or board-eligible in pediatric cardiology, and have clinical experience in performing physiologic and angiographic procedures.

C. All anesthesia services should be provided by or supervised by a board-certified anesthesiologist.

In the case of pediatric catheterization services, the anesthesiologist should be experienced and trained in pediatric anesthesiology.

Cardiac catheterization services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-390. Accessibility Need for new service.

Open heart surgery services should be available 24 hours per day 7 days per week and accessible within a 60 minutes driving time one way, under normal conditions, for 95% of the population of the planning district.

A. No new fixed site cardiac catheterization [ laboratory service ] should be approved for a [ health ] planning district unless:

1. Existing fixed site cardiac catheterization [ laboratories services ] located in the [ health ] planning district performed an average of 1,200 cardiac catheterization DEPs [ per existing and approved laboratory ] for the relevant reporting period; [ and ]

2. The proposed new service will perform an average of 200 DEPs in the first year of operation and 500 DEPs in the second year of operation; and

3. The utilization of existing services in the [ health ] planning district will not be significantly reduced.

B. Proposals for mobile cardiac catheterization laboratories should be approved only if such laboratories will be provided at a site located on the campus of an inpatient hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform an average of 200 DEPs in the first year of operation and 350 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the [ health ] planning district below 1,200 procedures.

C. [ Consideration Preference ] may be given [ for to a project that locates ] new cardiac catheterization services [ located ] at an inpatient hospital that is 60 minutes or more driving time one way under normal conditions from existing [ laboratories services ] if the applicant can demonstrate that the proposed new laboratory will perform an average of 200 DEPs in the first year of operation and 400 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the [ health ] planning district.

12VAC5-230-400. Availability Expansion of services.

A. No new open heart services should be approved unless:

1. The service will be made available in a general hospital with established cardiac catheterization services that have been used for at least 960 diagnostic equivalent procedures for the relevant reporting period and have been in operation for at least 30 months;

2. All existing open heart surgery rooms located in the planning district have been used for at least 400 open heart surgical procedures for the relevant reporting period; and

3. It can be reasonably projected that the proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without reducing the utilization of existing open heart surgery programs in the planning district to less than 400 open heart procedures performed at those existing services.

B. Notwithstanding subsection A of this subsection, consideration will be given to the approval of new open heart surgery services located at a general hospital more than 60 minutes driving time one way, under normal conditions, from any site in which open heart surgery services are currently available if it can be projected that the proposed new service will perform at least 150 open heart procedures in the first year of operation; and 200 procedures in the second year of operation without reducing the utilization of existing open heart surgery rooms to less than 400 procedures per room within 2 hours driving time one way, under normal conditions, from the proposed new service location.

Such hospitals should also have provided at least 960 diagnostic-equivalent cardiac catheterization procedures during the relevant reporting period on equipment that has been in operation at least 30 months.

C. Proposals for the expansion of open heart surgery services should not be approved unless all existing open heart surgery rooms operated by the applicant have performed at least:

1. 400 adult-equivalent open heart surgery procedures in the relevant reporting period when the proposed facility is within two hours driving time one way, under normal conditions, of an existing open heart surgery service; or

2. 300 adult-equivalent open heart surgery procedures in the relevant reporting period when the applicant proposes expanding services in excess of two hours driving time, under normal conditions, of an existing open heart surgery service.

D. No new or expanded pediatric open heart surgery services should be approved unless the proposed new or expanded service is provided at a hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed at least 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides neonatal special care.

Proposals to increase cardiac catheterization services should be approved only when:

1. All existing cardiac catheterization laboratories operated by the applicant's facilities where the proposed expansion is to occur have performed an average of 1,200 DEPs [ per existing and approved laboratory ] for the relevant reporting period; and

2. The applicant can demonstrate that the expanded service will achieve an average of 200 DEPs per laboratory in the first 12 months of operation and 400 DEPs in the second 12 months of operation without significantly reducing the utilization of existing cardiac catheterization laboratories in the [ health ] planning district.

12VAC5-230-410. Staffing Pediatric cardiac catheterization.

A. Open heart surgery services should have a medical director certified by the American Board of Thoracic Surgery in cardiovascular surgery with special qualifications and experience in cardiac surgery.

In the case of pediatric open heart surgery, the medical director shall be certified by the American Board of Thoracic Surgery in cardiovascular surgery and experience in pediatric cardiovascular surgery and congenital heart disease.

B. All physicians performing open heart surgery procedures should be board-certified or board-eligible in cardiovascular surgery, with experience in cardiac surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitably trained board-certified or board-eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. There should also be present at least one board-certified or board-eligible anesthesiologist with experience in open heart surgery.

In the case of pediatric open heart surgery services, each physician performing and assisting with pediatric procedures should be board-certified or board-eligible in cardiovascular surgery with experience in pediatric cardiovascular surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitably trained board-certified or board-eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. All pediatric procedures should include a board-certified anesthesiologist with experience in pediatric anesthesiology and pediatric open heart surgery.

No new or expanded pediatric cardiac catheterization services should be approved unless:

1. The proposed service will be provided at an inpatient hospital with open heart surgery services, pediatric tertiary care services or specialty or subspecialty level neonatal special care;

2. The applicant can demonstrate that the proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation; and

3. The utilization of existing pediatric cardiac catheterization laboratories in the [ health ] planning district will not be reduced below 100 procedures per year.

Part V
General Surgical Services

12VAC5-230-420. Accessibility Nonemergent cardiac catheterization.

Surgical services should be available within 30 minutes driving time one way, under normal conditions, for 95% of the population of the planning district.

Proposals to provide elective interventional cardiac procedures such as PTCA, transseptal puncture, transthoracic left ventricle puncture, myocardial biopsy or any valvuoplasty procedures, diagnostic pericardiocentesis or therapeutic procedures should be approved only when open heart surgery services are available on-site in the same hospital in which the proposed non-emergent cardiac service will be located.

12VAC5-230-430. Availability Staffing.

A. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a planning district, exclusive of Level I and Level II Trauma Centers dedicated to the needs of the trauma service, dedicated cesarean section rooms, or operating rooms designated exclusively for open heart surgery, will be determined as follows:

FOR= ((ORV/POP) x (PROPOP)) x AHORV

1600

ORV = the sum of total operating room visits (inpatient and outpatient) in the planning district in the most recent five years for which operating room utilization data has been reported by Virginia Health Information; and

POP = the sum of total population in the planning district in the most recent five years for which operating room utilization data has been reported by Virginia Health Information, as found in the most current projections of the Virginia Employment Commission.

PROPOP = the projected population of the planning district five years from the current year as reported in the most current projections of the Virginia Employment Commission.

AHORV = the average hours per general purpose operating room visit in the planning district for the most recent year for which average hours per general purpose operating room visit has been calculated from information collected by Virginia Health Information.

FOR = future general purpose operating rooms needed in the planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room that is available 40 hours per week, 50 weeks per year.

B. Projects involving the relocation of existing general purpose operating rooms within a planning district may be authorized when it can be reasonably documented that such relocation will improve the distribution of surgical services within a planning district by making services available within 30 minutes driving time one way, under normal conditions, of 95% of the planning district's population.

A. Cardiac catheterization services should have a medical director who is board certified in cardiology and has clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. Cardiac catheterization services should be under the direct supervision or one or more qualified physicians. Such physicians should have clinical experience in performing physiologic and angiographic procedures.

Pediatric catheterization services should be under the direct supervision of one or more qualified physicians. Such physicians should have clinical experience in performing pediatric physiologic and angiographic procedures.

Part VI
General Inpatient Services

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-440. Accessibility Travel time.

Acute care inpatient facility beds A. Open heart surgery services should be within 30 60 minutes driving time one way, under normal conditions, of 95% of the population of a the [ health ] planning district [ using mapping software as determined by the commissioner ].

B. Such services shall be available 24 hours a day, seven days a week.

12VAC5-230-450. Availability Need for new service.

A. Subject to the provisions of 12VAC5-230-80, no new inpatient beds should be approved in any planning district unless:

1. The resulting number of beds does not exceed the number of beds projected to be needed, for each inpatient bed category, for that planning district for the fifth planning horizon year;

2. The average annual occupancy, based on the number of beds, is at least 70% (midnight census) for the relevant reporting period; or

3. The intensive care bed capacity has an average annual occupancy of at least 65% for the relevant reporting period, based on the number of beds.

A. No new open heart services should be approved unless:

1. The service will be available in an inpatient hospital with an established cardiac catheterization service that has performed an average of 1,200 DEPs for the relevant reporting period and has been in operation for at least 30 months;

2. Open heart surgery [ programs services ] located in the [ health ] planning district performed an average of 400 open heart and closed heart surgical procedures for the relevant reporting period; and

3. The proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without significantly reducing the utilization of existing open heart surgery [ programs services ] in the [ health ] planning district [ below 400 open and closed heart procedures ].

B. No proposal to replace or relocate inpatient beds to a location not contiguous to the existing site should be approved unless:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The beds to be replaced experienced an average annual utilization of 70% (midnight census) for general inpatient beds and 65% for intensive care beds in the relevant reporting period;

4. The number of beds to be moved off site is taken out of service at the existing facility; and

5. The off-site replacement of beds results in: (i) a decrease in the licensed bed capacity; (ii) a substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or (iii) generally improved operating efficiency in the applicant's facility or facilities.

B. [ Consideration Preference ] may be given to [ a project that locates ] new open heart surgery services [ located ] at an inpatient hospital more than 60 minutes driving time one way under normal condition from any site in which open heart surgery services are currently available [ when and ]:

1. The proposed new service will perform an average of 150 open heart procedures in the first year of operation and 200 procedures in the second year of operation without significantly reducing the utilization of existing open heart surgery rooms within two hours driving time one way under normal conditions from the proposed new service location below 400 procedures per room; and

2. The hospital provided an average of 1,200 cardiac catheterization DEPs during the relevant reporting period in a service that has been in operation at least 30 months.

C. For proposals involving a capital expenditure of $5 million or more, and involving the conversion of underutilized beds to medical/surgical, pediatric or intensive care, consideration will be given to a proposal if: (i) there is a projected need in the category of inpatient beds that would result from the conversion; and (ii) it can be demonstrated that the average annual occupancy of the beds to be converted would reach the standard in subdivisions B 1, 2 and 3 for the bed category that would result from the conversion, by the first year of operation.

D. In addition to the terms of 12VAC5-230-80, a need for additional general inpatient beds may be demonstrated if the total number of beds in a given category in the planning district is less than the number of such beds projected as necessary to meet demand in the fifth planning horizon year for which the application is submitted.

E. The number of medical/surgical beds projected to be needed in a planning district shall be computed as follows:

1. Determine the projected total number of medical/surgical and pediatric inpatient days for the fifth planning horizon year as follows:

a. Add the medical/surgical and pediatric inpatient days for the past three years for all acute care inpatient facilities in the planning district as reported in the Annual Survey of Hospitals;

b. Add the projected planning district population for the same three year period as reported by the Virginia Employment Commission;

c. Divide the total of the medical/surgical and pediatric inpatient days by the total of the population and express the resulting rate in days per 1,000 population;

d. Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in thousands) for the fifth planning horizon year.

2. Determine the projected number of medical/surgical and pediatric beds that may be needed in the planning district for the planning horizon year as follows:

a. Divide the result in subdivision E 1 d of this subsection by 365;

b. Divide the quotient obtained by 0.80 in planning districts in which 50% or more of the population resides in nonrural areas or 0.75 in planning districts in which less than 50% of the population resides in nonrural areas.

3. Determine the projected number of medical/surgical and pediatric beds that may be established or relocated within the planning district for the fifth planning horizon year as follows:

a. Determine the number of medical/surgical and pediatric beds as reported in the inventory;

b. Subtract the number of beds identified in subdivision E 1 from the number of beds needed as determined in subdivision E 2 b of this subsection. If the difference indicated is positive, then a need may exist for additional medical/surgical or pediatric beds. If the difference is negative, then no need for additional beds exists.

F. The projected need for intensive care beds shall be computed as follows:

1. Determine the projected total number of intensive care inpatient days for the fifth planning horizon year as follows:

a. Add the intensive care inpatient days for the past three years for all inpatient facilities in the planning district as reported in the annual survey of hospitals;

b. Add the planning district's projected population for the same three-year period as reported by the Virginia Employment Commission;

c. Divide the total of the intensive care days by the total of the population to obtain the rate in days per 1,000 population;

d. Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in thousands) for the fifth planning horizon year to yield the expected intensive care patient days.

2. Determine the projected number of intensive care beds that may be needed in the planning district for the planning horizon year as follows:

a. Divide the number of days projected in subdivision F 1 d of this subsection by 365 to yield the projected average daily census;

b. Calculate the beds needed to assure with 99% probability that an intensive care bed will be available for unscheduled admissions.

3. Determine the projected number of intensive care beds that may be established or relocated within the planning district for the fifth planning horizon year as follows:

a. Determine the number of intensive care beds as reported in the inventory.

b. Subtract the number of beds identified in subdivision F 3 a of this subsection from the number of beds needed as determined in subdivision F 2 b of this subsection. If the difference is positive, then a need may exist for additional intensive care beds. If the difference is negative, then no need for additional beds exists.

G. No hospital should relocate beds to a new location if underutilized beds (less than 85% average annual occupancy for medical/surgical and pediatric beds), when the relocation involves such beds, and less than 65% average annual occupancy for intensive care beds when relocation involves such beds, are available within 30 minutes of the site of the proposed hospital.

Part VII
Nursing Facilities

12VAC5-230-460. Accessibility Expansion of service.

A. Nursing facility beds should be accessible within 60 minutes driving time one way, under normal conditions, to 95% of the population in a planning region.

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. Preference will be given to proposals that improve geographic access and reduce travel time to nursing facilities within a planning district

Proposals to [ increase expand ] open heart surgery services shall demonstrate that existing open heart surgery rooms operated by the applicant have performed an average of:

1. 400 adult equivalent open heart surgery procedures in the relevant reporting period [ of if ] the proposed increase is within one hour driving time one way under normal conditions of an existing open heart surgery service, or

2. 300 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed service is in excess of one hour driving time one way under normal conditions of an existing open heart surgery service in the [ health ] planning district.

12VAC5-230-470. Availability Pediatric open heart surgery services.

A. No planning district shall be considered to have a need for additional nursing facility beds unless (i) the bed need forecast in that planning district (see subsection D of this section) exceeds the current inventory of beds in that planning district and (ii) the estimated average annual occupancy of all existing Medicaid-certified nursing facility beds in the planning district was at least 93% for the most recent two years following the first year of operation of new beds, excluding the bed inventory and utilization of the Virginia Veterans Care Center.

B. No planning district shall be considered to have a need for additional beds if there are unconstructed beds designated as Medicaid-certified.

C. Proposals for expanding existing nursing facilities should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 93% in the most recent year for which bed utilization has been reported to the department.

Exceptions will be considered for facilities that operated at less than 93% average annual occupancy in the most recent year for which bed utilization has been reported when the facility has a rehabilitative or other specialized care focus that results in a relatively short average length of stay, causing an average annual occupancy lower than 93% for the facility.

D. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85) where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP64 = The population aged 0 to 64 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP69 = The population aged 65 to 69 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP74 = The population aged 70 to 74 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP79 = The population aged 75 to 79 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP84 = The population aged 80 to 84 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP85+ = The population aged 85 and older projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

Planning district bed need forecasts will be rounded as follows:

Planning District Bed Need	Rounded Bed Need
1-29	0
30-44	30
45-84	60
85-104	90
105-134	120
135-164	150
165-194	180
195-224	210
225+	240

The above applies, except in the case of a planning district that has two or more nursing facilities, has had an average annual occupancy rate in excess of 93% for the most recent two years for which bed utilization has been reported to the department, and has a forecasted bed need of 15 to 29 beds. In such a case, the bed need for this planning district will be rounded to 30.

E. No new freestanding nursing facilities of less than 90 beds should be authorized. Consideration will be given to new freestanding facilities with fewer than 90 nursing facility beds when such facilities can be justified on the basis of a lack of local demand for a larger facility and a maldistribution of nursing facility beds within a planning district.

F. Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities will be considered when:

1. The total number of new or additional beds plus any existing nursing facility beds operated by the continuing care provider does not exceed 10% of the continuing care provider's total existing or planned independent living and adult care residence;

2. The proposed beds are necessary to meet existing or reasonably anticipated obligations to provide care to present or prospective residents of the continuing care facility;

3. The applicant agrees in writing not to seek certification for the use of such new or additional beds by persons eligible to receive Medicaid;

4. The applicant agrees in writing to obtain the resident's written acknowledgement, prior to admission, that the applicant does not serve Medicaid recipients and that, in the event such resident becomes a Medicaid recipient and is eligible for nursing facility placement, the resident will not be eligible for placement in the CCRC's nursing facility unit;

5. The applicant agrees in writing that only continuing care contract holders who have resided in the CCRC as independent living residents or adult care residents will be admitted to the nursing facility unit after the first three years of operation.

G. The construction cost of proposed nursing facilities should be comparable to the most recent cost for similar facilities in the same health planning region. Consideration should be given to the current capital cost reimbursement methodology utilized by the Department of Medical Assistance Services.

H. Consideration should be given to applicants proposing to replace outdated and functionally obsolete facilities with modern nursing facilities that will result in the more cost efficient delivery of health care services to residents in a more aesthetically pleasing and comfortable environment. Proponents of the replacement and relocation of nursing facility beds should demonstrate that the replacement and relocation are reasonable and could result in savings in other cost centers, such as realized operational economies of scale and lower maintenance costs.

No new [ or expanded ] pediatric open heart surgery service should be approved unless the proposed new [ or expended ] service is provided at an inpatient hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed an average of 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides specialty or subspecialty neonatal special care.

Part VIII
Lithotripsy Services

12VAC5-230-480. Accessibility Staffing.

A. The waiting time for lithotripsy services should be no more than one week Open heart surgery services should have a medical director who is board certified in cardiovascular or cardiothoracic surgery by the appropriate board of the American Board of Medical Specialists.

In the case of pediatric cardiac surgery, the medical director should be board certified in cardiovascular or cardiothoracic surgery, with special qualifications and experience in pediatric cardiac surgery and congenital heart disease, by the appropriate board of the American Board of Medical Specialists.

B. Lithotripsy services should be available within 30 minutes driving time in urban areas and 45 minutes driving time one way, under normal conditions, for 95% of the population of the health planning region Cardiac surgery should be under the direct supervision of one or more qualified physicians.

Pediatric cardiac surgery services should be under the direct supervision of one or more qualified physicians.

Part V
General Surgical Services

12VAC5-230-490. Availability Travel time.

A. Consideration will be given to new lithotripsy services established at a general hospital through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, provided the hospital has referred at least two patients per week, or 100 patients annually, for the relevant reporting period to other facilities for lithotripsy services.

B. A new service may be approved at the site of any general hospital or hospital-based clinic or licensed outpatient surgical hospital provided the service is provided by:

1. A vendor currently providing services in Virginia;

2. A vendor not currently providing services who can demonstrate that the proposed unit can provide at least 750 procedures annually at all sites served; or

3. An applicant who can demonstrate that the proposed unit can provide at least 750 procedures annually at all sites to be served.

C. Proposals for the expansion of services by existing vendors or providers of such services may be approved if it can be demonstrated that each existing unit owned or operated by that vendor or provider has provided a minimum of 750 procedures annually at all sites served by the vendor or provider.

D. A new or expanded lithotripsy service may be approved when the applicant is a consortium of hospitals or a hospital network, when a majority of procedures will be provided at sites or facilities owned or operated by the hospital consortium or by the hospital network.

Surgical services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Part IX
Organ Transplant

12VAC5-230-500. Accessibility Need for new service.

A. Organ transplantation services should be accessible within two hours driving time one way, under normal conditions, of 95% of Virginia's population. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a [ health ] planning district, exclusive of [ procedure rooms, ] dedicated cesarean section rooms, operating rooms designated exclusively for cardiac surgery, procedures rooms or VDH-designated trauma services, shall be determined as follows:

	FOR = ((ORV/POP) x (PROPOP)) x AHORV
	1600

Where:

ORV = the sum of total inpatient and outpatient general purpose operating room visits in the [ health ] planning district in the most recent [ three five ] years for which general purpose operating room utilization data has been reported by VHI; and

POP = the sum of total population in the [ health ] planning district as reported by a demographic entity as determined by the commissioner, for the same [ three year five-year ] period as used in determining ORV.

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

AHORV = the average hours per general purpose operating room visit in the [ health ] planning district for the most recent year for which average hours per general purpose operating room visits have been calculated as reported by VHI.

FOR = future general purpose operating rooms needed in the [ health ] planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room available 40 hours per week, 50 weeks per year.

B. Providers of organ transplantation services should facilitate access to pre- and post-transplantation services needed by patients residing in rural locations by establishing part-time satellite clinics Projects involving the relocation of existing [ general purpose ] operating rooms within a [ health ] planning district may be authorized when it can be reasonably documented that such relocation will [ : (i) ] improve the distribution of surgical services within a [ health ] planning district by making services available within 30 minutes driving time one way under normal conditions of 95% of the planning district's population; (ii) result in the provision of the same surgical services at a lower cost to surgical patients in the health planning district; or (iii) optimize the number of operations in the health planning district that are performed on an outpatient basis ].

12VAC5-230-510. Availability Staffing.

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Proposals to expand existing transplantation programs shall demonstrate that existing organ transplantation services comply with all applicable Medicare program coverage criteria. Surgical services should be under the direction or supervision of one or more qualified physicians.

Part VI
Inpatient Bed Requirements

12VAC5-230-520. Minimum utilization; minimum survival rate; service proficiency; systems operations Travel time.

A. Proposals to establish or expand organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number of transplants required by organ system is:

Kidney	30
Pancreas or kidney/pancreas	12
Heart	17
Heart/Lung	12
Lung	12
Liver	21
Intestine	2

Performance of minimum transplantation volumes does not indicate a need for additional transplantation capacity or programs.

B. Preference will be given to expansion of successful existing services, either by enabling necessary increases in the number of organ systems being transplanted or by adding transplantation capability for additional organ systems, rather than developing additional programs that could reduce average program volume.

C. Facilities should demonstrate that they will achieve and maintain minimum transplant patient survival rates. Minimum one-year survival rates, listed by organ system, are:

Kidney	95%
Pancreas or kidney/pancreas	90%
Heart	85%
Heart/Lung	60%
Lung	77%
Liver	86%
Intestine	77%

D. Proposals to add additional organ transplantation services should demonstrate at least two years successful experience with all existing organ transplantation systems.

E. All physicians that perform transplants should be board-certified by the appropriate professional examining board, and should have a minimum of one year of formal training and two years of experience in transplant surgery and post-operative care.

Inpatient beds should be within 30 minutes driving time one way under normal conditions of 95% of the population of a [ health ] planning district [ using a mapping software as determined by the commissioner ].

Part X
Miscellaneous Capital Expenditures

12VAC5-230-530. Purpose Need for new service.

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other parts of the SMFP addressing changes in bed or service capacity used in the COPN review process.

A. No new inpatient beds should be approved in any [ health ] planning district unless:

1. The resulting number of beds for each bed category contained in this article does not exceed the number of beds projected to be needed for that [ health ] planning district for the fifth planning horizon year; and

2. The average annual occupancy based on the number of beds in the [ health ] planning district for the relevant reporting period is:

a. 80% at midnight census for medical/surgical or pediatric beds;

b. 65% at midnight census for intensive care beds.

B. For proposals to convert under-utilized beds that require a capital expenditure of $15 million or more, consideration may be given to such proposal if:

1. There is a projected need in the applicable category of inpatient beds; and

2. The applicant can demonstrate that the average annual occupancy of the converted beds would meet the utilization standard for the applicable bed category by the first year of operation.

For the purposes of this part, "underutilized" means less than 80% average annual occupancy for medical/surgical or pediatric beds, when the relocation involves such beds and less than 65% average annual occupancy for intensive care beds when relocation involves such beds.

12VAC5-230-540. Project need Need for medical/surgical beds.

All applications involving the expenditure of $5 million dollars or more by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

The number of medical/surgical beds projected to be needed in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for the medical/surgical beds for the [ health ] planning district using the formula:

BUR = (IPD/PoP) x 1,000

Where:

BUR = the bed use rate for the [ health ] planning district.

IPD = the sum of total inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient day data has been reported by VHI; and

PoP = the sum of total population [ greater than ] 18 years of age [ and older ] in the [ health ] planning district for the same [ three five ] years used to determine IPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of medical/surgical beds needed for the [ health ] planning district in five years from the current year using the formula:

ProBed = ((BUR x ProPop)/365)/0.80

Where:

ProBed = The projected number of medical/surgical beds needed in the [ health ] planning district for five years from the current year.

BUR = the bed use rate for the [ health ] planning district determined in subdivision 1 of this section.

ProPop = the projected population [ greater than ] 18 years of age [ and older ] of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of medical/surgical beds that are needed in the [ health ] planning district for the five planning horizon years as follows:

NewBed = ProBed – CurrentBed

Where:

NewBed = the number of new medical/surgical beds that can be established in a [ health ] planning district, if the number is positive. If NewBed is a negative number, no additional medical/surgical beds should be authorized for the [ health ] planning district.

ProBed = the projected number of medical/surgical beds needed in the [ health ] planning district for five years from the current year determined in subdivision 2 of this section.

CurrentBed = the current inventory of licensed and authorized medical/surgical beds in the [ health ] planning district.

12VAC5-230-550. Facilities expansion Need for pediatric beds.

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion are inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

The number of pediatric beds projected to be needed in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for pediatric beds for the [ health ] planning district using the formula:

PBUR = (PIPD/PedPop) x 1,000

Where:

PBUR = The pediatric bed use rate for the [ health ] planning district.

PIPD = The sum of total pediatric inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient days data has been reported by VHI; and

PedPop = The sum of population under [ 19 18 ] years of age in the [ health ] planning district for the same [ three five ] years used to determine PIPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of pediatric beds needed to the [ health ] planning district in five years from the current year using the formula:

ProPedBed = ((PBUR x ProPedPop)/365)/0.80

Where:

ProPedBed = The projected number of pediatric beds needed in the [ health ] planning district for five years from the current year.

PBUR = The pediatric bed use rate for the [ health ] planning district determined in subdivision 1 of this section.

ProPedPop = The projected population under [ 19 18 ] years of age of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of pediatric beds needed within the [ health ] planning district for the fifth planning horizon year as follows:

NewPedBed – ProPedBed – CurrentPedBed

Where:

NewPedBed = the number of new pediatric beds that can be established in a [ health ] planning district, if the number is positive. If NewPedBed is a negative number, no additional pediatric beds should be authorized for the [ health ] planning district.

ProPedBed = the projected number of pediatric beds needed in the [ health ] planning district for five years from the current year determined in subdivision 2 of this section.

CurrentPedBed = the current inventory of licensed and authorized pediatric beds in the [ health ] planning district.

12VAC5-230-560. Renovation or modernization Need for intensive care beds.

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent three-year period.

The projected need for intensive care beds in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for ICU beds for the [ health ] planning district using the formula:

ICUBUR = (ICUPD/Pop) x 1,000

Where:

ICUBUR = The ICU bed use rate for the [ health ] planning district.

ICUPD = The sum of total ICU inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient day data has been reported by VHI; and

Pop = The sum of population [ greater than ] 18 years of age [ or older for adults or under 18 for pediatric patients ] in the [ health ] planning district for the same [ three five ] years used to determine ICUPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of ICU beds needed for the [ health ] planning district, including bed availability for unscheduled admissions, five years from the current year using the formula:

ProICUBed = ((ICUBUR x ProPop)/365)/0.65

Where:

ProICUBed = The projected number of ICU beds needed in the [ health ] planning district for five years from the current year;

ICUBUR = The ICU bed use rate for the [ health ] planning district as determine in subdivision 1 of this section;

ProPop = The projected population [ greater than ] 18 years of age [ or older for adults or under 18 for pediatric patients ] of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of ICU beds that may be established or relocated within the [ health ] planning district for the fifth planning horizon planning year as follows:

NewICUB = ProICUBed – CurrentICUBed

Where:

NewICUBed = The number of new ICU beds that can be established in a [ health ] planning district, if the number is positive. If NewICUBed is a negative number, no additional ICU beds should be authorized for the [ health ] planning district.

ProICUBed = The projected number of ICU beds needed in the [ health ] planning district for five years from the current year as determined in subdivision 2 of this section.

CurrentICUBed = The current inventory of licensed and authorized ICU beds in the [ health ] planning district.

12VAC5-230-570. Equipment Expansion or relocation of services.

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

A. Proposals to relocate beds to a location not contiguous to the existing site should be approved only when:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The number of beds to be moved off-site is taken out of service at the existing facility;

4. The off-site replacement of beds results in:

a. A decrease in the licensed bed capacity;

b. A substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or

c. Generally improved operating efficiency in the applicant's facility or facilities; and

5. The relocation results in improved distribution of existing resources to meet community needs.

B. Proposals to relocate beds within a [ health ] planning district where underutilized beds are within 30 minutes driving time one way under normal conditions of the site of the proposed relocation should be approved only when the applicant can demonstrate that the proposed relocation will not materially harm existing providers.

Part XI
Medical Rehabilitation

12VAC5-230-580. Accessibility Long-term acute care hospitals (LTACHs).

Comprehensive inpatient rehabilitation services should be available within 60 minutes driving time one way, under normal conditions, of 95% of the population of the planning region.

A. LTACHs will not be considered as a separate category for planning or licensing purposes. All LTACH beds remain part of the inventory of inpatient hospital beds.

B. A LTACH shall only be approved if an existing hospital converts existing medical/surgical beds to LTACH beds or if there is an identified need for LTACH beds within a [ health ] planning district. New LTACH beds that would result in an increase in total licensed beds above 165% of the average daily census for the [ health ] planning district will not be approved. Excess inpatient beds within an applicant's existing acute care facilities must be converted to fill any unmet need for additional LTACH beds.

C. If an existing or host hospital converts existing beds for use as LTACH beds, those beds must be delicensed from the bed inventory of the existing hospital. If the LTACH ceases to exist, terminates its services, or does not offer services for a period of 12 months within its first year of operation, the beds delicensed by the host hospital to establish the LTACH shall revert back to that host hospital.

If the LTACH ceases operation in subsequent years of operation, the host hospital may reacquire the LTACH beds by obtaining a COPN, provided the beds are to be used exclusively for their original intended purpose and the application meets all other applicable project delivery requirements. Such an application shall not be subject to the standard batch review cycle and shall be processed as allowed under Part VI (12VAC5-220-280 et seq.) of the Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations.

D. The application shall delineate the service area for the LTACH by documenting the expected areas from which it is expected to draw patients.

E. A LTACH shall be established for 10 or more beds.

F. A LTACH shall become certified by the Centers for Medicare and Medicaid Services (CMS) as a long-term acute care hospital and shall not convert to a hospital for patients needing a length of stay of less than 25 days without obtaining a certificate of public need.

1. If the LTACH fails to meet the CMS requirements as a LTACH within 12 months after beginning operation, it may apply for a six-month extension of its COPN.

2. If the LTACH fails to meet the CMS requirements as a LTACH within the extension period, then the COPN granted pursuant to this section shall expire automatically.

12VAC5-230-590. Availability Staffing.

A. The number of comprehensive and specialized rehabilitation beds needed in a health planning region will be projected as follows:

((UR x PROJ. POP.)/365)/.90

Where UR = the use rate expressed as rehabilitation patient days per population in the health planning region as reported in the most recent "Industry Report for Virginia Hospitals and Nursing Facilities" published by Virginia Health Information; and

PROJ.POP. = the most recent projected population of the health planning region three years from the current year as published by the Virginia Employment Commission.

B. No additional rehabilitation beds should be authorized for a health planning region in which existing rehabilitation beds were utilized at an average annual occupancy of less than 90% in the most recently reported year.

Preference will be given to the development of needed rehabilitation beds through the conversion of underutilized medical/surgical beds.

C. Notwithstanding subsection A of this section, the need for proposed inpatient rehabilitation beds will be given consideration when:

1. The rehabilitation specialty proposed is not currently offered in the health planning region; and

2. A documented basis for recognizing a need for the service or beds is provided by the applicant.

Inpatient services should be under the direction or supervision of one or more qualified physicians.

Part VII
Nursing Facilities

12VAC5-230-600. Staffing Travel time.

Medical rehabilitation facilities should have full-time medical direction by a physiatrist or other physician with a minimum of two years experience in the proposed specialized inpatient medical rehabilitation program.

A. Nursing facility beds should be accessible within 30 minutes driving time one way under normal conditions to 95% of the population in a [ health ] planning district [ using mapping software as determined by the commissioner ].

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. [ Consideration will Preference may ] be given to proposals that improve geographic access and reduce travel time to nursing facilities within a [ health ] planning district.

Part XII
Mental Health Services

Article 1
Psychiatric and Substance Abuse Disorder Treatment Services

12VAC5-230-610. Accessibility Need for new service.

A. Acute psychiatric, acute substance abuse disorder treatment services, and intermediate care substance abuse disorder treatment services should be available within 60 minutes driving time one way, under normal conditions, of 95% of the population.

B. Existing and proposed acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment service providers shall have established plans for the provision of services to indigent patients which include, at a minimum: (i) the minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients; (ii) the minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation; (iii) the minimum number of unreimbursed patient days to be provided to local community services boards; and (iv) a description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

C. Proposed acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment service providers shall have formal agreements with their identified community services boards that: (i) specify the number of charity care patient days that will be provided to the community service board; (ii) describe the mechanisms to monitor compliance with charity care provisions; (iii) provide for effective discharge planning for all patients, including return to the patients place of origin or home state if not Virginia; and (iv) consider admission priorities based on relative medical necessity.

D. Providers of acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment services serving large geographic areas should establish satellite outpatient facilities to improve patient access, where appropriate and feasible.

A. A [ health ] planning district should be considered to have a need for additional nursing facility beds when:

1. The bed need forecast exceeds the current inventory of beds for the [ health ] planning district; and

2. The average annual occupancy of all existing and authorized Medicaid-certified nursing facility beds in the [ health ] planning district was at least 93%, excluding the bed inventory and utilization of the Virginia Veterans Care Centers.

Exception: When there are facilities that have been in operation less than three years in the [ health ] planning district, their occupancy can be excluded from the calculation of average occupancy if the facilities [ has had ] an annual occupancy of at least 93% in one of its first three years of operation.

B. No [ health ] planning district should be considered in need of additional beds if there are unconstructed beds designated as Medicaid-certified. This presumption of ‘no need' for additional beds extends for three years [ or the date on the certificate, whichever is longer, for the unconstructed beds from the issuance date of the certificate ].

C. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85)

Where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP64 = The population aged 0 to 64 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP69 = The population aged 65 to 69 projected for the [ health ] planning district three years from the current year as most recently published by the a demographic program as determined by the commissioner.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP74 = The population aged 70 to 74 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP79 = The population aged 75 to 79 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP84 = The population aged 80 to 84 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP85+ = The population aged 85 and older projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

[ Planning Health planning ] district bed need forecasts will be rounded as follows:

[ Planning Health Planning ] District Bed Need	Rounded Bed Need
1-29	0
30-44	30
45-84	60
85-104	90
105-134	120
135-164	150
165-194	180
195-224	210
225+	240

Exception: When a [ health ] planning district has:

1. Two or more nursing facilities;

2. Had an average annual occupancy rate in excess of 93% for the most recent two years for which bed utilization has been reported to VHI; and

3. Has a forecasted bed need of 15 to 29 beds, then the bed need for this [ health ] planning district will be rounded to 30.

D. No new freestanding nursing facilities of less than 90 beds should be authorized. However, consideration may be given to a new freestanding facility with fewer than 90 nursing facility beds when the applicant can demonstrate that such a facility is justified based on a locality's preference for such smaller facility and there is a documented poor distribution of nursing facility beds within the [ health ] planning district.

E. When evaluating the [ capital ] cost of a project, consideration may be given to projects that use the current methodology as determined by the Department of Medical Assistance Services.

F. [ Consideration Preference ] may be given to [ proposals to projects that ] replace outdated and functionally obsolete facilities with modern facilities that result in the more cost-efficient resident services in a more aesthetically pleasing and comfortable environment.

12VAC5-230-620. Availability Expansion of services.

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROJ.POP. = the projected population of the planning district five years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-80, no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

However, consideration will be given to the addition of acute psychiatric or acute substance abuse disorder beds by existing medical care facilities in planning districts with an excess supply of beds when such additions can be justified on the basis of facility-specific utilization or geographic remoteness, i.e., driving time of 60 minutes or more, one way under normal conditions, to alternate acute care facilities. If the facility with the institutional need for beds is part of a hospital network, underutilized beds at the other facilities within the network should be relocated to the facility with the institutional need if possible.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.80

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROJ.POP. = the projected population of the planning district five years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

E. Preference will be given to the development of needed acute psychiatric and intermediate substance abuse disorder treatment beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and to have contractual agreements to serve populations served by Community Services Boards, whether through conversion of underutilized general hospital beds or development of new beds.

F. The number of intermediate care substance disorder abuse treatment beds needed in a planning district with existing intermediate care substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the planning district expressed as the average intermediate care substance abuse disorder treatment patient days per population reported for the most recent three-year period; and

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

G. Subject to the provisions of 12VAC5-230-80, no additional intermediate care substance abuse disorder treatment beds should be authorized for a planning district with existing intermediate care substance abuse disorder treatment beds if the existing inventory of such beds is greater than the need identified. No beds in facilities operated by DMHMRSAS will be included in the inventory of intermediate care substance abuse disorder beds.

However, consideration will be given to the addition of intermediate care substance abuse disorder treatment beds by existing medical care facilities in planning districts with an excess supply of beds when such addition can be justified on the basis of facility-specific utilization or geographic remoteness, i.e., driving time of 60 minutes or more one way under normal conditions, to alternate acute care facilities. If the facility with the institutional need for beds is part of a hospital network, underutilized beds at the other facilities within the network should be relocated to the facility with the institutional need if possible.

H. No existing intermediate care substance abuse disorder treatment beds should be relocated from one site to another unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing intermediate care substance abuse disorder treatment providers to continue to provide historic levels of service to indigent patients.

I. The number of intermediate care substance abuse disorder treatment beds needed in a planning district without existing intermediate care substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average intermediate care substance abuse disorder treatment patient days per population reported for the most recent three-year period;

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

J. Preference will be given to the development of needed intermediate care substance abuse disorder treatment beds through the conversion of underutilized general hospital beds.

Proposals to increase existing nursing facility bed capacity should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 93% in the relevant reporting period as reported to VHI.

Note: Exceptions will be considered for facilities that operated at less than 93% average annual occupancy in the most recent year for which bed utilization has been reported when the facility [ has a rehabilitative or other specialized care program causing a short average length of stay resulting in offers short stay services causing ] an average annual occupancy lower than 93% for the facility.

Article 2
Mental Retardation

12VAC5-230-630. Availability Continuing care retirement communities.

The establishment of new ICF/MR facilities should not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility.

6. The proposed new facility is consistent with the current DMHMRSAS Comprehensive Plan and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities (CCRC) will be considered when:

[ 1. The facility is registered with the State Corporation Commission as a continuing care provider pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia; ]

[ 1. 2. ] The [ total ] number of [ new or additional beds plus any existing ] nursing facility beds [ operated by the continuing care provider does not exceed 20% of the continuing care provider's total existing or planned independent living and adult care residence requested in the initial application does not exceed the lesser of 20% of the continuing care retirement community's total number of beds that are not nursing home beds or 60 beds ];

[ 2. 3. ] The [ proposed beds are necessary to meet existing or reasonably anticipated obligations to provide care to present or prospective residents of the continuing care facility number of new nursing facility beds requested in any subsequent application does not cause the continuing care retirement community's total number of nursing home beds to exceed 20% of its total number of beds that are not nursing facility beds ]; and

[ 3. The applicant certifies that :

a. The CCRC has, or will have, a qualified resident assistance fund and that the facility will not rely on federal and state public assistance funds for reimbursement of the proposed beds;

b. The continuing care contract or disclosure statement, as required by § 38.2-4902 of the Code of Virginia, has been filed with the State Corporation Commission and that the commission has deemed the contract or disclosure statement in compliance with applicable law; and

c. Only continuing care contract holders residing in the CCRC as independent living residents or adult care residents or who is a family member of a contract holder residing in a non-nursing facility portion of the CCRC will be admitted to the nursing facility unit after the first three years of operation.

4. The continuing care retirement community has established a qualified resident assistance policy. ]

12VAC5-230-640. Continuity; integration Staffing.

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary. Nursing facilities shall be under the direction or supervision of a licensed nursing home administrator and staffed by licensed and certified nursing personnel qualified as required by law.

Part VIII
Lithotripsy Service

12VAC5-230-650. Acceptability Travel time.

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations of the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services. Lithotripsy services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the health planning region [ using mapping software as determined by the commissioner ].

Part XIII
Perinatal Services

Article 1
Criteria and Standards for Obstetrical Services

12VAC5-230-660. Accessibility Need for new service.

Obstetrical services should be located within 30 minutes driving time one way, under normal conditions, of 95% of the population in rural areas and within 30 minutes driving time one way, under normal conditions, in urban and suburban areas.

A. [ Consideration Preference ] may be given to [ a project that establishes ] new renal or orthopedic lithotripsy services [ established ] at a new facility through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, [ provided and ] the facility has referred at least two appropriate patients per week, or 100 appropriate patients annually, for the relevant reporting period to other facilities for either renal or orthopedic lithotripsy services.

B. A new renal lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 750 renal lithotripsy procedures annually.

C. A new orthopedic lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 500 orthopedic lithotripsy procedures annually.

12VAC5-230-670. Availability Expansion of services.

A. Proposals to establish new obstetrical services in rural areas should demonstrate that obstetrical volumes within the travel times listed in 12VAC5-230-660 will not be negatively affected.

B. Proposals to establish new obstetrical services in urban and suburban areas should demonstrate that a minimum of 2,500 deliveries will be performed annually by the second year of operation and that obstetrical volumes of existing providers located within the travel times listed in 12VAC5-230-660 will not be negatively affected.

C. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service will be given preference over the addition of new services or the expansion of single service providers.

A. Proposals to [ increase expand ] renal lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 750 procedures annually at all sites served by the vendor or provider.

B. Proposals to [ increase expand ] orthopedic lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 500 procedures annually at all sites served by the vendor or provider.

12VAC5-230-680. Continuity Adding or expanding mobile lithotripsy services.

A. Perinatal service capacity should be developed and sized to provide routine newborn care to infants delivered in the associated obstetrics service, and shall have the capability to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The application should identify the primary and secondary neonatal special care center nearest the proposed service and provide travel time one way, under normal conditions, to those centers.

A. Proposals for mobile lithotripsy services should demonstrate that, for the relevant reporting period, at least 125 procedures were performed and that the proposed mobile unit will not reduce the utilization of existing machines in the [ health ] planning region.

B. Proposals to convert a mobile lithotripsy service to a fixed site lithotripsy service should demonstrate that, for the relevant reporting period, at least 430 procedures were performed and the proposed conversion will not reduce the utilization of existing providers in the [ health ] planning district.

Article 2
Neonatal Special Care Services

12VAC5-230-690. Accessibility Staffing.

Neonatal special care services should be located within an average of 45 minutes driving time one way, under normal conditions, in urban and suburban areas of hospitals providing general-level newborn services. Lithotripsy services should be under the direction or supervision of one or more qualified physicians.

Part IX
Organ Transplant

12VAC5-230-700. Availability Travel time.

A. Existing neonatal special care units located within the travel times listed in 12VAC5-230-660 should achieve 65% average annual occupancy before new services can be added to the planning region Organ transplantation services should be accessible within two hours driving time one way under normal conditions of 95% of Virginia's population [ using mapping software as determined by the commissioner ].

B. Preference will be given to the expansion of existing services rather than the creation of new services Providers of organ transplantation services should facilitate access to pre and post transplantation services needed by patients residing in rural locations be establishing part-time satellite clinics.

12VAC5-230-710. Neonatal services Need for new service.

The application should identify the service area, levels of service, and capacity of the current general-level newborn service hospitals to be served within the identified area.

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Performance of minimum transplantation volumes as cited in 12VAC5-230-720 does not indicate a need for additional transplantation capacity or programs.

12VAC5-230-720. Transplant volumes; survival rates; service proficiency; systems operations.

A. Proposals to establish organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number transplants of required by organ system is:

Kidney	30
Pancreas or kidney/pancreas	12
Heart	17
Heart/Lung	12
Lung	12
Liver	21
Intestine	2

Note: Any proposed pancreas transplant program must be a part of a kidney transplant program that has achieved a minimum volume standard of 30 cases per year for kidney transplants as well as the minimum transplant survival rates stated in subsection B of this section.

B. Applicants shall demonstrate that they will achieve and maintain at least the minimum transplant patient survival rates. Minimum one-year survival rates listed by organ system are:

Kidney	95%
Pancreas or kidney/pancreas	90%
Heart	85%
Heart/Lung	70%
Lung	77%
Liver	86%
Intestine	77%

12VAC5-230-730. Expansion of transplant services.

A. Proposals to [ increase expand ] organ transplantation services shall demonstrate at least two years successful experience with all existing organ transplantation systems at the hospital.

B. [ Consideration will Preference may ] be given to [ expanding successful existing services through increases in a project expanding ] the number of organ systems being transplanted [ at a successful existing service ] rather than developing new programs that could reduce existing program volumes.

12VAC5-230-740. Staffing.

Organ transplant services should be under the direct supervision of one or more qualified physicians.

Part X
Miscellaneous Capital Expenditures

12VAC5-230-750. Purpose.

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other service specific parts addressed elsewhere in this chapter.

12VAC5-230-760. Project need.

All applications involving the expenditure of $15 million or more by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

12VAC5-230-770. Facilities expansion.

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion is inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

12VAC5-230-780. Renovation or modernization.

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent five-year period.

12VAC5-230-790. Equipment.

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

Part XI
Medical Rehabilitation

12VAC5-230-800. Travel time.

Medical rehabilitation services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

12VAC5-230-810. Need for new service.

A. The number of comprehensive and specialized rehabilitation beds shall be determined as follows:

((UR x PROPOP)/365)/ [ .85 .80 ]

Where:

UR = the use rate expressed as rehabilitation patient days per population in the [ health ] planning district as reported by VHI; and

PROPOP = the most recent projected population of the [ health ] planning district five years from the current year as published by a demographic entity as determined by the commissioner.

B. Proposals for new medical rehabilitation beds should be considered when the applicant can demonstrate that:

1. The rehabilitation specialty proposed is not currently offered in the [ health ] planning district; and

2. There is a documented need for the service or beds in the [ health ] planning district.

12VAC5-230-820. Expansion of services.

No additional rehabilitation beds should be authorized for a [ health ] planning district in which existing rehabilitation beds were utilized with an average annual occupancy of less than [ 85% 80% ] in the most recently reported year.

[ Exception: Consideration Preference ] may be given to [ expanding a project to expand ] rehabilitation beds [ through the conversion of by converting ] underutilized medical/surgical beds.

12VAC5-230-830. Staffing.

Medical rehabilitation facilities should be under the direction or supervision of one or more qualified physicians.

Part XII
Mental Health Services

Article 1
Acute Psychiatric and Acute Substance Abuse Disorder Treatment Services

12VAC5-230-840. Travel time.

Acute psychiatric and acute substance abuse disorder treatment services should be available within 60 minutes driving time one way under normal conditions of 95% of the population [ using mapping software as determined by the commissioner ].

12VAC5-230-850. Continuity; integration.

A. Existing and proposed acute psychiatric and acute substance abuse disorder treatment providers shall have established plans for the provision of services to indigent patients that include:

1. The minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients;

2. The minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation;

3. The minimum number of unreimbursed patient days to be provided to local community services boards; and

4. A description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

B. Proposed acute psychiatric and acute substance abuse disorder treatment providers shall have formal agreements with the appropriate local community services boards or behavioral health authority that:

1. Specify the number of patient days that will be provided to the community service board;

2. Describe the mechanisms to monitor compliance with charity care provisions;

3. Provide for effective discharge planning for all patients, including return to the patient's place of origin or home state if not Virginia; and

4. Consider admission priorities based on relative medical necessity.

C. Providers of acute psychiatric and acute substance abuse disorder treatment serving large geographic areas should establish satellite outpatient facilities to improve patient access where appropriate and feasible.

12VAC5-230-860. Need for new service.

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a [ health ] planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the [ health ] planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-70, no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a [ health ] planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

[ Consideration Preference ] may also be given to the addition of acute psychiatric or acute substance abuse beds dedicated for the treatment of geriatric patients in [ health ] planning districts with an excess supply of beds when such additions are justified on the basis of the specialized treatment needs of geriatric patients.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a [ health ] planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the health planning region in which the [ health ] planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

E. Preference [ will may ] be given to the development of needed acute psychiatric beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and that have contractual agreements to serve populations served by community services boards, whether through conversion of underutilized general hospital beds or development of new beds.

Article 2
Mental Retardation

12VAC5-230-870. Need for new service.

The establishment of new ICF/MR facilities with more than 12 beds shall not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility;

6. The proposed new facility will have a maximum of 20 beds and is consistent with any plan of the Department of Mental Health, Mental Retardation and Substance Abuse Sservices and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

12VAC5-230-880. Continuity; integration.

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary.

12VAC5-230-890. Compliance with licensure standards.

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations for the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services.

Part XIII
Perinatal [ and Obstetrical ] Services

Article 1
Criteria and Standards for Obstetrical Services

12VAC5-230-900. Travel time.

Obstetrical services should be located within 30 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

12VAC5-230-910. Need for new service.

[ A. ] No new obstetrical services should be approved unless the applicant can demonstrate that, based on the population and utilization of current services, there is a need for such services in the [ health ] planning district without [ significantly ] reducing the utilization of existing providers in the [ panning health planning ] district.

[ B. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service should be given preference over establishing new services or expanding single service providers. ]

12VAC5-230-920. Continuity.

A. Perinatal service capacity, including service availability for unscheduled admissions, should be developed to provide routine newborn care to infants delivered in the associated obstetrics service, and shall be able to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The proposal shall identify the primary and secondary neonatal special care center nearest the proposed service shall provide transport one-way to those centers.

12VAC5-230-930. Staffing.

Obstetric services should be under the direction or supervision of one or more qualified physicians.

Article 2
Neonatal Special Care Services

12VAC5-230-940. Travel time.

A. Intermediate level neonatal special care services should be located within 30 minutes driving time one way under normal conditions of hospitals providing general level new born services [ using mapping software as determined by the commissioner ].

B. Specialty and subspecialty neonatal special care services should be located within 90 minutes driving time one way under normal conditions of hospitals providing general or intermediate level newborn services [ using mapping software as determined by the commissioner ].

12VAC5-230-950. Need for new service.

[ A. ] No new level of neonatal service shall be offered by a hospital unless that hospital has first obtained a COPN granting approval to provide each such level of service.

[ B. Preference will be given to the expansion of existing services, rather than to the creation of new services. ]

12VAC5-230-960. Intermediate level newborn services.

A. Existing [ neonatal special care units providing ] intermediate level newborn services as designated in 12VAC5-410-443 [ , located within 30 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new intermediate level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing intermediate Intermediate ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of six bassinets [ , stations or beds ].

C. No more than four bassinets [ , stations and beds ] for intermediate level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

12VAC5-230-970. Specialty level newborn services.

A. Existing [ neonatal special care units providing ] specialty level newborn services as designated in 12VAC5-410-443 [ located within 90 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new specialty level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing specialty Specialty ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets [ , stations or beds. A station shall equal one bed ].

C. No more than four bassinets [ , stations and beds ] for specialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

D. Proposals to establish specialty level [ neonatal special care ] services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing specialty level [ neonatal special care newborn service ] providers located within the travel time listed in 12VAC5-230-940 will not be [ significantly ] reduced.

12VAC5-230-980. Subspecialty level newborn services.

A. Existing [ neonatal special care units providing ] subspecialty level newborn services as designated in 12VAC5-410-443 [ located within 90 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new subspecialty level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing subspecialty Subspecialty ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets [ , stations or beds. A station shall equal one bed ].

C. No more than four bassinets [ , stations and beds ] for subspecialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

D. Proposals to establish subspecialty level [ neonatal special care newborn ] services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing subspecialty level [ neonatal special care newborn ] providers located within the travel time listed in 12VAC5-230-940 will not be [ significantly ] reduced.

12VAC5-230-990. Neonatal services.

The application shall identify the service area and the levels of service of all the hospitals to be served by the proposed service.

12VAC5-230-1000. Staffing.

All levels of neonatal special care services should be under the direction or supervision of one or more qualified physicians as described in 12VAC5-410-443.

A. The minimum service volume of a mobile unit shall be prorated on a site-by-site basis reflecting the amount of time that proposed mobile units will be used, and existing mobile units have been used, during the relevant reporting period, at each site using the following formula:

Required full-time minimum service volume

X

Number of days the service will be on site each week

X 0.2 =

Prorated minimum services volume (not to exceed the required full-time minimum service volume) ]

B. [ This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the service has been achieved as described in the applicable service section The average annual utilization of existing and approved CT, MRI, PET, lithotripsy, and catheterization services in a health planning district shall be calculated for such services as follows:

(

Total volume of all units of the relevant service in the reporting period

)

X

100

=

% Average Utilization

(

# of existing or approved fixed units

X

Fixed unit minimum service volume

)

+

Y Utilization

Y = the sum of the minimum service volume of each mobile site in the health planning district with the minimum services volume for each such site prorated according to subsection A of this section.

C. This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the services has been achieved as described in the applicable service section. ]

D. Applicants shall not use this section to justify a need to establish new services.

12VAC5-230-80. Institutional need When institutional expansion needed.

A. Notwithstanding any other provisions of this chapter, consideration will be given to the commissioner may grant approval for the expansion of services at an existing medical care facilities facility in a [ health ] planning districts district with an excess supply of such services when the proposed expansion can be justified on the basis of facility-specific utilization a facility's need having exceeded its current service capacity to provide such service or on the geographic remoteness of the facility.

B. If a facility with an institutional need to expand is part of a network health system, the underutilized services at other facilities within the network should be relocated health system should be reallocated, when appropriate, to the facility within the planning district with the institutional need when possible to expand before additional services are approved for the applicant. However, underutilized services located at a health system's geographically remote facility may be disregarded when determining institutional need for the proposed project.

C. This section is not applicable to nursing facilities pursuant to § 32.1-102.3:2 of the Code of Virginia.

12VAC5-230-90. Compliance with the terms of a condition.

A. The commissioner may condition the approval of a COPN to provide care to Virginia's indigent population, patients with specialized needs, or the medically underserved.

B. The applicant shall actively seek to provide opportunities to offer the conditioned service directly to indigent or uninsured persons at a reduced rate or free of charge to patients with specialized needs, or by the facilitation of primary care services in designated medically underserved areas.

C. If the direct provision of the conditioned services does not fulfill the terms of the condition, the center may determine the applicant to be in compliance with the terms of the condition when:

1. The applicant is part of a facility or provider network and the facility or provider network has provided reduced rate or uncompensated care at or above the regional standard; or

2. The applicant provides direct financial support for community based health care services at a value equal to or greater than the difference between the terms of the condition and the amount of direct care provided.

Such direct financial support shall be in addition to, and not a substitute for, other charitable giving chosen by the applicant.

D. Acceptable proof for direct financial support is a signed receipt indicating the number or amount of services or other support provided and dollar value of that service or support. Applicants providing direct financial support for community based health care services should render that support through one of the following organizations:

1. The Virginia Association of Free Clinics;

2. The Virginia Health Care Foundation; or

3. The Virginia Primary Care Association.

E. Applicants shall demonstrate compliance with the terms of a condition for the previous 12-month period. The written condition report shall be certified or affirmed by the applicants and filed with the center. Such report shall include, but is not limited to, the:

1. Facility or service name and address;

2. Certificate number;

3. Facility or service gross patient revenues;

4. Dollar value of the charity care provided, excluding bad debts and disallowances from payers; and

5. Number of individuals served by the direct provision of care or a receipt from one of the allowable organizations listed in subsection D of this section.

Part II
Diagnostic Imaging Services

Article 1
Criteria and Standards for Computed Tomography

12VAC5-230-100. Accessibility 12VAC5-230-90. Travel time.

CT services should be within 30 minutes driving time one way, under normal conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

12VAC5-230-110 12VAC5-230-100. Need for new fixed site [ or mobile ] service.

A. No CT service should be approved at a location that is within 30 minutes driving time one way of:

1. A service that is not yet operational; or

2. An existing CT unit that has performed fewer than 3,000 scans during the relevant reporting period.

B. A. No new fixed site [ or mobile ] CT service or network shall should be approved unless all existing fixed site CT services or networks in the [ health ] planning district performed an average of 4,500 CT scans per machine during the relevant reporting period. [ 10,000 7,400 ] procedures per existing and approved CT scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing [ fixed site ] providers in the [ health ] planning district [ below 10,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of CT scanners in such [ health ] planning district.

C. Consideration may be given to new CT services proposed for sites located beyond 30 minutes driving time one way of existing facilities that do not meet the 4,500 scans per machine criterion if the proposed sites are in rural areas B. [ Existing ] CT scanners [ to be ] used solely for simulation with radiation therapy treatment shall be exempt from [ the utilization criteria of ] this article [ when applying for a COPN. In addition, existing CT scanners used solely for simulation with radiation therapy treatment may be disregarded in computing the average utilization of CT scanners in such health planning district ].

12VAC5-230-120 12VAC5-230-110. Expansion of existing fixed site service.

Proposals to increase the number of CT scanners in expand an existing medical care facility's CT service or network may through the addition of a CT scanner should be approved only if when the existing service or network services performed an average of 3,000 CT scans [ 10,000 7,400 ] procedures per scanner for the relevant reporting period. The commissioner may authorize placement of a new unit at the applicant's existing medical care facility or at a separate location within the applicant's primary service area for CT services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the [ health ] planning district [ below 10,000 procedures ].

12VAC5-230-120. Adding or expanding mobile CT services.

A. Proposals for mobile CT scanners shall demonstrate that, for the relevant reporting period, at least 4,800 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing CT providers in the [ health ] planning district [ below 10,000 procedures for fixed site scanners or 4,800 procedures for mobile scanners ].

B. Proposals to convert [ authorized ] mobile CT scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, at least 6,000 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing CT providers in the [ health ] planning district [ below 10,000 procedures for fixed site scanners or 4,800 procedures for mobile scanners ].

12VAC5-230-130. Staffing.

Providers of CT services should be under the direct supervision of one or more board-certified diagnostic radiologists direction or supervision of one or more qualified physicians.

12VAC5-230-140. Space.

Applicants shall provide documentation that:

1. A suitable environment will be provided for the proposed CT services, including protection against known hazards; and

2. Space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

Article 2
Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-150. Accessibility. 12VAC5-230-140. Travel time.

MRI services should be within 30 minutes driving time one way, under normal conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Article 2
Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-160 12VAC5-230-150. Need for new fixed site service.

A. No new fixed site MRI services shall should be approved unless all existing fixed site MRI services in the [ health ] planning district performed an average of 4,000 scans per machine 5,000 procedures per existing and approved fixed site MRI scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site MRI providers in the [ health ] planning district [ below 5,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of MRI scanners in such [ health ] planning district.

B. Consideration may be given to new MRI services proposed for sites located beyond 30 minutes driving time one way of existing facilities that do not meet the 4,000 scans per machine criterion of the prospered sites are in rural areas.

12VAC5-230-170 12VAC5-230-160. Expansion of services fixed site service.

Proposals to expand an existing medical care facility's MRI services through the addition of a new scanning unit of an MRI scanner may be approved if when the existing service performed at least 4,000 scans an average of 5,000 MRI procedures per existing unit scanner during the relevant reporting period. The commissioner may authorize placement of the new unit at the applicant's existing medical care facility, or at a separate location within the applicant's primary service area for MRI services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the [ health ] planning district [ below 5,000 procedures ].

12VAC5-230-170. Adding or expanding mobile MRI services.

A. Proposals for mobile MRI scanners shall demonstrate that, for the relevant reporting period, at least 2,400 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing MRI providers in the [ health ] planning district [ below 2,400 procedures for mobile scanners ].

B. Proposals to convert [ authorized ] mobile MRI scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, 3,000 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing MRI providers in the [ health ] planning district [ below 5,000 procedures for fixed site scanners and 2,400 procedures for mobile scanners ].

12VAC5-230-180. Staffing.

MRI machines services should be under the direct, on-site supervision of one or more board-certified diagnostic radiologists direct supervision of one or more qualified physicians.

12VAC5-230-190. Space.

Applicants should provide documentation that:

1. A suitable environment will be provided for the proposed MRI services, including shielding and protection against known hazards; and

2. Space will be provided for patient waiting, patient preparation, staff and patient bathrooms, staff activities, storage of records and supplies, and other space necessary to accommodate the needs of handicapped persons.

Article 3
Magnetic Source Imaging

12VAC5-230-200 12VAC5-230-190. Policy for the development of MSI services.

Because Magnetic Source Imaging (MSI) scanning systems are still in the clinical research stage of development with no third-party payment available for clinical applications, and because it is uncertain as to how rapidly this technology will reach a point where it is shown to be clinically suitable for widespread use and distribution on a cost-effective basis, it is preferred that the entry and development of this technology in Virginia should initially occur at or in affiliation with, the academic medical centers in the state.

Article 4
Positron Emission Tomography

12VAC5-230-210 12VAC5-230-200. Accessibility Travel time.

The service area for each proposed PET service shall be an entire planning district PET services should be within 60 minutes driving time one way under normal conditions of 95% of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

Article 4
Positron Emission Tomography

12VAC5-230-220 12VAC5-230-210. Need for new fixed site service.

A. Whether the applicant is a consortium of hospitals, a hospital network, or a single general hospital, at least 850 new PET appropriate cases should have been diagnosed in the planning district. If the applicant is a hospital, whether free-standing or within a hospital system, 850 new PET appropriate cases shall have been diagnosed and the hospital shall have provided radiation therapy services with specific ancillary services suitable for the equipment before a new fixed site PET service should be approved for the [ health ] planning district.

B. If the applicant is a general hospital, the facility shall provide radiation therapy services and specific ancillary services suitable for the equipment, and have reported at least 500 new courses of treatment or at least 8,000 treatment visits in the most recent reporting period No new fixed site PET services should be approved unless an average of 6,000 procedures [ preexisting per existing ] and approved fixed site PET scanner were performed in the [ health ] planning district during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site PET providers in the [ health ] planning district [ below 6,000 procedures ]. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of PET units in such [ panning health planning ] district.

Note: For the purposes of tracking volume utilization, an image taken with a PET/CT scanner that takes concurrent PET/CT images shall be counted as one PET procedure. Images made with PET/CT scanners that can take PET or CT images independently shall be counted as individual PET procedures and CT procedures respectively, unless those images are made concurrently.

C. If the applicant is a consortium of general hospitals or a hospital network, at least one of the consortium or network members shall provide radiation therapy services and specific ancillary services suitable for the equipment, and have reported at least 500 new PET appropriate patients.

D. Future applications of PET equipment shall be evaluated based on review of national literature.

12VAC5-230-230. Additional scanners. 12VAC5-230-220. Expansion of fixed site services.

No additional PET scanners shall be added in a planning district unless the applicant can demonstrate that the utilization of the existing PET service was at least 1,200 PET scans for a fixed site unit and that the proposed new or expanded service would not reduce the utilization after for existing services below 850 PET scans for a fixed site unit. The applicant shall also provide documentation that he project complies with 12VAC50-230-240. Proposals to increase the number of PET scanners in an existing PET service should be approved only when the existing scanners performed an average of 6,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing fixed site providers in the [ health ] planning district [ below 6,000 procedures ].

12VAC5-230-230. Adding or expanding mobile PET or PET/CT services.

A. Proposals for mobile PET or PET/CT scanners [ shall should ] demonstrate that, for the relevant reporting period, at least 230 [ procedures were performed PET or PET/CT appropriate patients were seen ] and that the proposed mobile unit will not significantly reduce the utilization of existing providers in the [ health ] planning district [ below 6,000 procedures for the fixed site PET providers or 230 procedures for the mobile PET providers ].

B. Proposals to convert [ authorized ] mobile PET or PET/CT scanners to fixed site scanners should demonstrate that, for the relevant reporting period, at least 1,400 procedures were performed [ by the mobile scanner ] and that the proposed conversion will not significantly reduce the utilization of existing providers in the [ health ] planning district [ below 6,000 procedures for the fixed site PET or 230 procedures of the mobile PET providers ].

12VAC5-230-240. Staffing.

PET services should be under the direction of a physician who is a board certified radiologist or supervision of one or more qualified physicians. Such physician physicians shall be a designated [ or ] authorized user [ users of isotopes used for PET ] by the Nuclear Regulatory Commission or licensed by the Office Division of Radiologic Health of the Virginia Department of Health, as applicable.

Article 5
Noncardiac Nuclear Imaging Criteria and Standards

12VAC5-230-250. Accessibility Travel time.

Noncardiac nuclear imaging services should be available within 30 minutes driving time one way, under normal driving conditions, of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

12VAC5-230-260. Introduction of a service Need for new service.

Any applicant proposing to establish a medical care facility for the provision of noncardiac nuclear imaging, or introducing nuclear imaging as a new service at an existing medical care facility, shall provide documentation that No new noncardiac imaging services should be approved unless the service can achieve a minimum utilization level of:

(i) 650 scans 1. 650 procedures in the first 12 months of operation, ;

(ii) 1,000 scans 2. 1,000 procedures in the second 12 months of services, and (iii) 1,250 scans service in the second 12 months of operation service; and

3. The proposed new service would not significantly reduce the utilization of existing providers in the [ health ] planning district.

Note: The utilization of an existing service operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of noncardiac nuclear imaging services in such [ health ] planning district.

12VAC5-230-270. Staffing.

The proposed new or expanded noncardiac nuclear imaging service shall should be under the direction of a board certified physician or supervision of one or more qualified physicians a designated [ or ] authorized user [ users of isotopes licensed ] by the Nuclear Regulatory Commission or the Office Division of Radiologic Health of the Virginia Department of Health, as applicable.

Part III
Radiation Therapy Services

Article 1
Radiation Therapy Services

12VAC5-230-280. Accessibility Travel time.

Radiation therapy services should be available within 60 minutes driving time one way, under normal conditions, for of 95% of the population of the [ health ] planning district [ using a mapping software as determined by the commissioner ].

12VAC5-230-290. Availability Need for new service.

A. No new radiation therapy service [ shall should ] be approved unless:

(i) existing 1. Existing radiation therapy machines located in the [ health ] planning district were used for at least 320 cancer cases and at least performed an average of 8,000 [ treatment visits procedures per existing and approved radiation therapy machine ] for in the relevant reporting period; and

(ii) it can be reasonably projected that the 2. The new service will perform at least 6,000 5,000 procedures by the third second year of operation without significantly reducing the utilization of existing radiation therapy machines within 60 minutes drive time one way, under normal conditions, such that less than 8,000 procedures will be performed by an existing machine providers in the [ health ] planning district.

B. The number of radiation therapy machines needed in a primary service area [ health ] planning district will be determined as follows:

	Population x Cancer Incidence Rate x 60%
	320

where:

1. The population is projected to be at least 75,000 150,000 people three years from the current year as reported in the most current projections of the Virginia Employment Commission a demographic entity as determined by the commissioner;

2. The "cancer incidence rate" is based on as determined by data from the Statewide Cancer Registry;

3. 60% is the estimated number of new cancer cases in a [ health ] planning district that are treatable with radiation therapy; and

4. 320 is 100% utilization of a radiation therapy machine based upon an anticipated average of 25 [ treatment visits procedures ] per case.

C. Consideration will be given to the approval of Proposals for new radiation therapy services located at a general hospital at least less than 60 minutes driving time one way, under normal conditions, from any site that radiation therapy services are available if the applicant can shall demonstrate that the proposed new services will perform at least an average of 4,500 [ treatment ] procedures annually by the second year of operation, without significantly reducing the utilization of existing machines located within 60 minutes driving time one way, under normal conditions, from the proposed new service location [ providers services ] in the [ health ] planning [ region district ].

D. Proposals for the expansion of radiation therapy services should not be approved unless all existing radiation therapy machines operated by the applicant in the planning district have performed at least 8,000 procedures for the relevant reporting period.

12VAC5-230-300. Statewide Cancer Registry Expansion of service.

Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia

Proposals to [ increase expand ] radiation therapy services should be approved only when all existing radiation therapy [ machines services ] operated by the applicant in the [ health ] planning district have performed an average of 8,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers [ below 8,000 procedures ].

12VAC5-230-310. Staffing Statewide Cancer Registry.

Radiation therapy services shall be under the direction of a physician board-certified in radiation oncology Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

12VAC5-230-320. Equipment, patient care; support services Staffing.

In addition to the radiation therapy machine, the service should have direct access to:

1. Simulation equipment capable of precisely producing the geometric relations of the equipment to be used for treatment of the patient;

2. A computerized treatment planning system;

3. A custom block design and cutting system; and

4. Diagnostic, laboratory oncology services

Radiation therapy services should be under the direction or supervision of one or more qualified physicians [ . Such physicians shall be ] designated [ or ] authorized [ users of isotopes licensed ] by the Nuclear Regulatory Commission or the Division of Radiologic Health of the Virginia Department of Health, as applicable.

Article 2
Criteria and Standards for Stereotactic Radiosurgery

12VAC5-230-330. Availability; need for new service Travel time.

No new services should be approved unless (i) the number of procedures performed with existing units in the planning region average more than 350 per year and (ii) it can be reasonably projected that the proposed new service will perform at least 250 procedures in the second year of operation without reducing patient volumes to existing providers to less than 350 procedures Stereotactic radiosurgery services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of a [ health ] planning [ district region using a mapping software as determined by the commissioner ].

12VAC5-230-340. Statewide Cancer Registry Need for new service.

Facilities shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

A. No new stereotactic radiosurgery services should be approved unless:

1. The number of procedures performed with existing units in the [ health ] planning region averaged more than 350 per year [ in the relevant reporting period ]; and

2. The proposed new service will perform at least 250 procedures in the second year of operation without significantly reducing the utilization of existing providers in the [ health ] planning region [ below 350 treatments ].

B. [ Consideration Preference ] may be given to a [ project that incorporates ] tereotactic radiosurgery service incorporated within an existing standard radiation therapy service using a linear accelerator when an average of 8,000 [ treatments procedures ] during the relevant reporting period [ were performed and the applicant can demonstrate that the volume and cost of the service is justified and utilization of existing services in the health planning region will not be significantly reduced ].

C. [ Consideration Preference ] may be given to a [ project that incorporates a ] dedicated Gamma Knife® [ incorporated ] within an existing radiation therapy service when:

1. At least 350 Gamma Knife® appropriate cases were referred out of the region in the relevant reporting period; and

2. The applicant can demonstrate that:

a. An average of 250 procedures will be preformed in the second year of operation; [ and ]

b. Utilization of existing services in the [ health ] planning region will not be significantly reduced [ below 350 treatments per year; and. ]

[ c. The cost is justified. ]

D. [ Consideration Preference ] may be given to [ a project that incorporates ] non-Gamma Knife® [ SRS ] technology [ incorporated ] within an existing radiation therapy service when:

1. The unit is not part of a linear accelerator;

2. An average of 8,000 radiation [ treatments procedures ] per year were performed by the existing radiation therapy services;

3. At least 250 procedures will be performed within the second year of operation; and

4. Utilization of existing services in the [ health ] planning region will not be significantly reduced [ below 350 treatments ].

12VAC5-230-350. Staffing Expansion of service.

The proposed new or expanded stereotactic radiosurgery services shall be under the direction of a physician who is board-certified in neurosurgery and a radiation oncologist with training in stereotactic radiosurgery

Proposals to increase the number of stereotactic radiosurgery services should be approved only when all existing stereotactic radiosurgery machines in the [ health ] planning region have performed an average of 350 procedures [ per existing and approved unit ] for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers in the [ health ] planning region [ below 350 procedures ].

Part IV
Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-360. Accessibility Statewide Cancer Registry.

Adult cardiac catheterization services should be accessible within 60 minutes driving time one way, under normal conditions, for 95% of the population of the planning district Facilities [ with stereotactic radiosurgery services ] shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

12VAC5-230-370. Availability Staffing.

A. No new fixed site cardiac catheterization laboratory should be approved unless:

1. All existing fixed site cardiac catheterization laboratories located in the planning district were used for at least 960 diagnostic-equivalent cardiac catheterization procedures for the relevant reporting period; and

2. It can be reasonably projected that the proposed new service will perform at least 200 diagnostic equivalent procedures in the first year of operation, 500 diagnostic equivalent procedures in the second year of operation without reducing the utilization of existing laboratories in the planning district to less than 960 diagnostic equivalent procedures at any of those existing laboratories.

B. Proposals for the use of freestanding or mobile cardiac catheterization laboratories shall be approved only if such laboratories will be provided at a site located on the campus of a general or community hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform 200 diagnostic equivalent procedures in the first year of operation, 350 diagnostic equivalent procedures in the second year of operation without reducing the utilization of existing laboratories in the planning district to less than 960 diagnostic equivalent procedures at any of those existing laboratories.

C. Consideration may be given for the approval of new cardiac catheterization services located at a general hospital located 60 minutes or more driving time one way, under normal conditions, from existing laboratories, if it can be projected that the proposed new laboratory will perform at least 200 diagnostic-equivalent procedures in the first year of operation, 400 diagnostic-equivalent procedures in the second year of operation without reducing the utilization of existing laboratories located within 60 minutes driving time one way, under normal conditions, of the proposed new service location.

D. Proposals for the addition of cardiac catheterization laboratories shall not be approved unless all existing cardiac catheterization laboratories operated in the planning district by the applicant have performed at least 1,200 diagnostic-equivalent procedures for the relevant reporting period, and the applicant can demonstrate that the expanded service will achieve a minimum of 200 diagnostic equivalent procedures per laboratory in the first 12 months of operation, 400 diagnostic equivalent procedures in the second 12 months of operation without reducing the utilization of existing cardiac catheterization laboratories in the planning district below 960 diagnostic equivalent procedures.

E. Emergency cardiac catheterization services shall be available within 30 minutes of admission to the facility.

F. No new or expanded pediatric cardiac catheterization services should be approved unless the proposed service will be provided at a hospital that:

1. Provides open heart surgery services, provides pediatric tertiary care services, has a pediatric intensive care unit and provides neonatal special care or has a cardiac intensive care unit and provides pediatric open heart surgery services; and

2. The applicant can demonstrate that each proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation.

G. Applications for new or expanded cardiac catheterization services that include nonemergent interventional cardiology services should not be approved unless emergency open heart surgery services are available within 15 minutes drive time in the hospital where the proposed cardiac catheterization service will be located.

Stereotactic radiosurgery services should be under the direction or supervision of one or more qualified physicians.

Part IV
Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-380. Staffing Travel time.

A. Cardiac catheterization services should have a medical director who is board-certified in cardiology and clinical experience in the performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. All physicians who will be performing cardiac catheterization procedures should be board-certified or board-eligible in cardiology and clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric catheterization services, each physician performing pediatric procedures should be board-certified or board-eligible in pediatric cardiology, and have clinical experience in performing physiologic and angiographic procedures.

C. All anesthesia services should be provided by or supervised by a board-certified anesthesiologist.

In the case of pediatric catheterization services, the anesthesiologist should be experienced and trained in pediatric anesthesiology.

Cardiac catheterization services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-390. Accessibility Need for new service.

Open heart surgery services should be available 24 hours per day 7 days per week and accessible within a 60 minutes driving time one way, under normal conditions, for 95% of the population of the planning district.

A. No new fixed site cardiac catheterization [ laboratory service ] should be approved for a [ health ] planning district unless:

1. Existing fixed site cardiac catheterization [ laboratories services ] located in the [ health ] planning district performed an average of 1,200 cardiac catheterization DEPs [ per existing and approved laboratory ] for the relevant reporting period; [ and ]

2. The proposed new service will perform an average of 200 DEPs in the first year of operation and 500 DEPs in the second year of operation; and

3. The utilization of existing services in the [ health ] planning district will not be significantly reduced.

B. Proposals for mobile cardiac catheterization laboratories should be approved only if such laboratories will be provided at a site located on the campus of an inpatient hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform an average of 200 DEPs in the first year of operation and 350 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the [ health ] planning district below 1,200 procedures.

C. [ Consideration Preference ] may be given [ for to a project that locates ] new cardiac catheterization services [ located ] at an inpatient hospital that is 60 minutes or more driving time one way under normal conditions from existing [ laboratories services ] if the applicant can demonstrate that the proposed new laboratory will perform an average of 200 DEPs in the first year of operation and 400 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the [ health ] planning district.

12VAC5-230-400. Availability Expansion of services.

A. No new open heart services should be approved unless:

1. The service will be made available in a general hospital with established cardiac catheterization services that have been used for at least 960 diagnostic equivalent procedures for the relevant reporting period and have been in operation for at least 30 months;

2. All existing open heart surgery rooms located in the planning district have been used for at least 400 open heart surgical procedures for the relevant reporting period; and

3. It can be reasonably projected that the proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without reducing the utilization of existing open heart surgery programs in the planning district to less than 400 open heart procedures performed at those existing services.

B. Notwithstanding subsection A of this subsection, consideration will be given to the approval of new open heart surgery services located at a general hospital more than 60 minutes driving time one way, under normal conditions, from any site in which open heart surgery services are currently available if it can be projected that the proposed new service will perform at least 150 open heart procedures in the first year of operation; and 200 procedures in the second year of operation without reducing the utilization of existing open heart surgery rooms to less than 400 procedures per room within 2 hours driving time one way, under normal conditions, from the proposed new service location.

Such hospitals should also have provided at least 960 diagnostic-equivalent cardiac catheterization procedures during the relevant reporting period on equipment that has been in operation at least 30 months.

C. Proposals for the expansion of open heart surgery services should not be approved unless all existing open heart surgery rooms operated by the applicant have performed at least:

1. 400 adult-equivalent open heart surgery procedures in the relevant reporting period when the proposed facility is within two hours driving time one way, under normal conditions, of an existing open heart surgery service; or

2. 300 adult-equivalent open heart surgery procedures in the relevant reporting period when the applicant proposes expanding services in excess of two hours driving time, under normal conditions, of an existing open heart surgery service.

D. No new or expanded pediatric open heart surgery services should be approved unless the proposed new or expanded service is provided at a hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed at least 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides neonatal special care.

Proposals to increase cardiac catheterization services should be approved only when:

1. All existing cardiac catheterization laboratories operated by the applicant's facilities where the proposed expansion is to occur have performed an average of 1,200 DEPs [ per existing and approved laboratory ] for the relevant reporting period; and

2. The applicant can demonstrate that the expanded service will achieve an average of 200 DEPs per laboratory in the first 12 months of operation and 400 DEPs in the second 12 months of operation without significantly reducing the utilization of existing cardiac catheterization laboratories in the [ health ] planning district.

12VAC5-230-410. Staffing Pediatric cardiac catheterization.

A. Open heart surgery services should have a medical director certified by the American Board of Thoracic Surgery in cardiovascular surgery with special qualifications and experience in cardiac surgery.

In the case of pediatric open heart surgery, the medical director shall be certified by the American Board of Thoracic Surgery in cardiovascular surgery and experience in pediatric cardiovascular surgery and congenital heart disease.

B. All physicians performing open heart surgery procedures should be board-certified or board-eligible in cardiovascular surgery, with experience in cardiac surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitably trained board-certified or board-eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. There should also be present at least one board-certified or board-eligible anesthesiologist with experience in open heart surgery.

In the case of pediatric open heart surgery services, each physician performing and assisting with pediatric procedures should be board-certified or board-eligible in cardiovascular surgery with experience in pediatric cardiovascular surgery. In addition to the cardiovascular surgeon who performs the procedure, there should be a suitably trained board-certified or board-eligible cardiovascular surgeon acting as an assistant during the open heart surgical procedure. All pediatric procedures should include a board-certified anesthesiologist with experience in pediatric anesthesiology and pediatric open heart surgery.

No new or expanded pediatric cardiac catheterization services should be approved unless:

1. The proposed service will be provided at an inpatient hospital with open heart surgery services, pediatric tertiary care services or specialty or subspecialty level neonatal special care;

2. The applicant can demonstrate that the proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation; and

3. The utilization of existing pediatric cardiac catheterization laboratories in the [ health ] planning district will not be reduced below 100 procedures per year.

Part V
General Surgical Services

12VAC5-230-420. Accessibility Nonemergent cardiac catheterization.

Surgical services should be available within 30 minutes driving time one way, under normal conditions, for 95% of the population of the planning district.

Proposals to provide elective interventional cardiac procedures such as PTCA, transseptal puncture, transthoracic left ventricle puncture, myocardial biopsy or any valvuoplasty procedures, diagnostic pericardiocentesis or therapeutic procedures should be approved only when open heart surgery services are available on-site in the same hospital in which the proposed non-emergent cardiac service will be located.

12VAC5-230-430. Availability Staffing.

A. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a planning district, exclusive of Level I and Level II Trauma Centers dedicated to the needs of the trauma service, dedicated cesarean section rooms, or operating rooms designated exclusively for open heart surgery, will be determined as follows:

FOR= ((ORV/POP) x (PROPOP)) x AHORV

1600

ORV = the sum of total operating room visits (inpatient and outpatient) in the planning district in the most recent five years for which operating room utilization data has been reported by Virginia Health Information; and

POP = the sum of total population in the planning district in the most recent five years for which operating room utilization data has been reported by Virginia Health Information, as found in the most current projections of the Virginia Employment Commission.

PROPOP = the projected population of the planning district five years from the current year as reported in the most current projections of the Virginia Employment Commission.

AHORV = the average hours per general purpose operating room visit in the planning district for the most recent year for which average hours per general purpose operating room visit has been calculated from information collected by Virginia Health Information.

FOR = future general purpose operating rooms needed in the planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room that is available 40 hours per week, 50 weeks per year.

B. Projects involving the relocation of existing general purpose operating rooms within a planning district may be authorized when it can be reasonably documented that such relocation will improve the distribution of surgical services within a planning district by making services available within 30 minutes driving time one way, under normal conditions, of 95% of the planning district's population.

A. Cardiac catheterization services should have a medical director who is board certified in cardiology and has clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. Cardiac catheterization services should be under the direct supervision or one or more qualified physicians. Such physicians should have clinical experience in performing physiologic and angiographic procedures.

Pediatric catheterization services should be under the direct supervision of one or more qualified physicians. Such physicians should have clinical experience in performing pediatric physiologic and angiographic procedures.

Part VI
General Inpatient Services

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-440. Accessibility Travel time.

Acute care inpatient facility beds A. Open heart surgery services should be within 30 60 minutes driving time one way, under normal conditions, of 95% of the population of a the [ health ] planning district [ using mapping software as determined by the commissioner ].

B. Such services shall be available 24 hours a day, seven days a week.

12VAC5-230-450. Availability Need for new service.

A. Subject to the provisions of 12VAC5-230-80, no new inpatient beds should be approved in any planning district unless:

1. The resulting number of beds does not exceed the number of beds projected to be needed, for each inpatient bed category, for that planning district for the fifth planning horizon year;

2. The average annual occupancy, based on the number of beds, is at least 70% (midnight census) for the relevant reporting period; or

3. The intensive care bed capacity has an average annual occupancy of at least 65% for the relevant reporting period, based on the number of beds.

A. No new open heart services should be approved unless:

1. The service will be available in an inpatient hospital with an established cardiac catheterization service that has performed an average of 1,200 DEPs for the relevant reporting period and has been in operation for at least 30 months;

2. Open heart surgery [ programs services ] located in the [ health ] planning district performed an average of 400 open heart and closed heart surgical procedures for the relevant reporting period; and

3. The proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without significantly reducing the utilization of existing open heart surgery [ programs services ] in the [ health ] planning district [ below 400 open and closed heart procedures ].

B. No proposal to replace or relocate inpatient beds to a location not contiguous to the existing site should be approved unless:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The beds to be replaced experienced an average annual utilization of 70% (midnight census) for general inpatient beds and 65% for intensive care beds in the relevant reporting period;

4. The number of beds to be moved off site is taken out of service at the existing facility; and

5. The off-site replacement of beds results in: (i) a decrease in the licensed bed capacity; (ii) a substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or (iii) generally improved operating efficiency in the applicant's facility or facilities.

B. [ Consideration Preference ] may be given to [ a project that locates ] new open heart surgery services [ located ] at an inpatient hospital more than 60 minutes driving time one way under normal condition from any site in which open heart surgery services are currently available [ when and ]:

1. The proposed new service will perform an average of 150 open heart procedures in the first year of operation and 200 procedures in the second year of operation without significantly reducing the utilization of existing open heart surgery rooms within two hours driving time one way under normal conditions from the proposed new service location below 400 procedures per room; and

2. The hospital provided an average of 1,200 cardiac catheterization DEPs during the relevant reporting period in a service that has been in operation at least 30 months.

C. For proposals involving a capital expenditure of $5 million or more, and involving the conversion of underutilized beds to medical/surgical, pediatric or intensive care, consideration will be given to a proposal if: (i) there is a projected need in the category of inpatient beds that would result from the conversion; and (ii) it can be demonstrated that the average annual occupancy of the beds to be converted would reach the standard in subdivisions B 1, 2 and 3 for the bed category that would result from the conversion, by the first year of operation.

D. In addition to the terms of 12VAC5-230-80, a need for additional general inpatient beds may be demonstrated if the total number of beds in a given category in the planning district is less than the number of such beds projected as necessary to meet demand in the fifth planning horizon year for which the application is submitted.

E. The number of medical/surgical beds projected to be needed in a planning district shall be computed as follows:

1. Determine the projected total number of medical/surgical and pediatric inpatient days for the fifth planning horizon year as follows:

a. Add the medical/surgical and pediatric inpatient days for the past three years for all acute care inpatient facilities in the planning district as reported in the Annual Survey of Hospitals;

b. Add the projected planning district population for the same three year period as reported by the Virginia Employment Commission;

c. Divide the total of the medical/surgical and pediatric inpatient days by the total of the population and express the resulting rate in days per 1,000 population;

d. Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in thousands) for the fifth planning horizon year.

2. Determine the projected number of medical/surgical and pediatric beds that may be needed in the planning district for the planning horizon year as follows:

a. Divide the result in subdivision E 1 d of this subsection by 365;

b. Divide the quotient obtained by 0.80 in planning districts in which 50% or more of the population resides in nonrural areas or 0.75 in planning districts in which less than 50% of the population resides in nonrural areas.

3. Determine the projected number of medical/surgical and pediatric beds that may be established or relocated within the planning district for the fifth planning horizon year as follows:

a. Determine the number of medical/surgical and pediatric beds as reported in the inventory;

b. Subtract the number of beds identified in subdivision E 1 from the number of beds needed as determined in subdivision E 2 b of this subsection. If the difference indicated is positive, then a need may exist for additional medical/surgical or pediatric beds. If the difference is negative, then no need for additional beds exists.

F. The projected need for intensive care beds shall be computed as follows:

1. Determine the projected total number of intensive care inpatient days for the fifth planning horizon year as follows:

a. Add the intensive care inpatient days for the past three years for all inpatient facilities in the planning district as reported in the annual survey of hospitals;

b. Add the planning district's projected population for the same three-year period as reported by the Virginia Employment Commission;

c. Divide the total of the intensive care days by the total of the population to obtain the rate in days per 1,000 population;

d. Multiply the days per 1,000 population rate by the projected population for the planning district (expressed in thousands) for the fifth planning horizon year to yield the expected intensive care patient days.

2. Determine the projected number of intensive care beds that may be needed in the planning district for the planning horizon year as follows:

a. Divide the number of days projected in subdivision F 1 d of this subsection by 365 to yield the projected average daily census;

b. Calculate the beds needed to assure with 99% probability that an intensive care bed will be available for unscheduled admissions.

3. Determine the projected number of intensive care beds that may be established or relocated within the planning district for the fifth planning horizon year as follows:

a. Determine the number of intensive care beds as reported in the inventory.

b. Subtract the number of beds identified in subdivision F 3 a of this subsection from the number of beds needed as determined in subdivision F 2 b of this subsection. If the difference is positive, then a need may exist for additional intensive care beds. If the difference is negative, then no need for additional beds exists.

G. No hospital should relocate beds to a new location if underutilized beds (less than 85% average annual occupancy for medical/surgical and pediatric beds), when the relocation involves such beds, and less than 65% average annual occupancy for intensive care beds when relocation involves such beds, are available within 30 minutes of the site of the proposed hospital.

Part VII
Nursing Facilities

12VAC5-230-460. Accessibility Expansion of service.

A. Nursing facility beds should be accessible within 60 minutes driving time one way, under normal conditions, to 95% of the population in a planning region.

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. Preference will be given to proposals that improve geographic access and reduce travel time to nursing facilities within a planning district

Proposals to [ increase expand ] open heart surgery services shall demonstrate that existing open heart surgery rooms operated by the applicant have performed an average of:

1. 400 adult equivalent open heart surgery procedures in the relevant reporting period [ of if ] the proposed increase is within one hour driving time one way under normal conditions of an existing open heart surgery service, or

2. 300 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed service is in excess of one hour driving time one way under normal conditions of an existing open heart surgery service in the [ health ] planning district.

12VAC5-230-470. Availability Pediatric open heart surgery services.

A. No planning district shall be considered to have a need for additional nursing facility beds unless (i) the bed need forecast in that planning district (see subsection D of this section) exceeds the current inventory of beds in that planning district and (ii) the estimated average annual occupancy of all existing Medicaid-certified nursing facility beds in the planning district was at least 93% for the most recent two years following the first year of operation of new beds, excluding the bed inventory and utilization of the Virginia Veterans Care Center.

B. No planning district shall be considered to have a need for additional beds if there are unconstructed beds designated as Medicaid-certified.

C. Proposals for expanding existing nursing facilities should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 93% in the most recent year for which bed utilization has been reported to the department.

Exceptions will be considered for facilities that operated at less than 93% average annual occupancy in the most recent year for which bed utilization has been reported when the facility has a rehabilitative or other specialized care focus that results in a relatively short average length of stay, causing an average annual occupancy lower than 93% for the facility.

D. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85) where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP64 = The population aged 0 to 64 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP69 = The population aged 65 to 69 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP74 = The population aged 70 to 74 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP79 = The population aged 75 to 79 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP84 = The population aged 80 to 84 projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the planning district as determined in the most recent nursing home patient origin study authorized by the department.

PP85+ = The population aged 85 and older projected for the planning district three years from the current year as most recently published by the Virginia Employment Commission.

Planning district bed need forecasts will be rounded as follows:

Planning District Bed Need	Rounded Bed Need
1-29	0
30-44	30
45-84	60
85-104	90
105-134	120
135-164	150
165-194	180
195-224	210
225+	240

The above applies, except in the case of a planning district that has two or more nursing facilities, has had an average annual occupancy rate in excess of 93% for the most recent two years for which bed utilization has been reported to the department, and has a forecasted bed need of 15 to 29 beds. In such a case, the bed need for this planning district will be rounded to 30.

E. No new freestanding nursing facilities of less than 90 beds should be authorized. Consideration will be given to new freestanding facilities with fewer than 90 nursing facility beds when such facilities can be justified on the basis of a lack of local demand for a larger facility and a maldistribution of nursing facility beds within a planning district.

F. Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities will be considered when:

1. The total number of new or additional beds plus any existing nursing facility beds operated by the continuing care provider does not exceed 10% of the continuing care provider's total existing or planned independent living and adult care residence;

2. The proposed beds are necessary to meet existing or reasonably anticipated obligations to provide care to present or prospective residents of the continuing care facility;

3. The applicant agrees in writing not to seek certification for the use of such new or additional beds by persons eligible to receive Medicaid;

4. The applicant agrees in writing to obtain the resident's written acknowledgement, prior to admission, that the applicant does not serve Medicaid recipients and that, in the event such resident becomes a Medicaid recipient and is eligible for nursing facility placement, the resident will not be eligible for placement in the CCRC's nursing facility unit;

5. The applicant agrees in writing that only continuing care contract holders who have resided in the CCRC as independent living residents or adult care residents will be admitted to the nursing facility unit after the first three years of operation.

G. The construction cost of proposed nursing facilities should be comparable to the most recent cost for similar facilities in the same health planning region. Consideration should be given to the current capital cost reimbursement methodology utilized by the Department of Medical Assistance Services.

H. Consideration should be given to applicants proposing to replace outdated and functionally obsolete facilities with modern nursing facilities that will result in the more cost efficient delivery of health care services to residents in a more aesthetically pleasing and comfortable environment. Proponents of the replacement and relocation of nursing facility beds should demonstrate that the replacement and relocation are reasonable and could result in savings in other cost centers, such as realized operational economies of scale and lower maintenance costs.

No new [ or expanded ] pediatric open heart surgery service should be approved unless the proposed new [ or expended ] service is provided at an inpatient hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed an average of 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides specialty or subspecialty neonatal special care.

Part VIII
Lithotripsy Services

12VAC5-230-480. Accessibility Staffing.

A. The waiting time for lithotripsy services should be no more than one week Open heart surgery services should have a medical director who is board certified in cardiovascular or cardiothoracic surgery by the appropriate board of the American Board of Medical Specialists.

In the case of pediatric cardiac surgery, the medical director should be board certified in cardiovascular or cardiothoracic surgery, with special qualifications and experience in pediatric cardiac surgery and congenital heart disease, by the appropriate board of the American Board of Medical Specialists.

B. Lithotripsy services should be available within 30 minutes driving time in urban areas and 45 minutes driving time one way, under normal conditions, for 95% of the population of the health planning region Cardiac surgery should be under the direct supervision of one or more qualified physicians.

Pediatric cardiac surgery services should be under the direct supervision of one or more qualified physicians.

Part V
General Surgical Services

12VAC5-230-490. Availability Travel time.

A. Consideration will be given to new lithotripsy services established at a general hospital through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, provided the hospital has referred at least two patients per week, or 100 patients annually, for the relevant reporting period to other facilities for lithotripsy services.

B. A new service may be approved at the site of any general hospital or hospital-based clinic or licensed outpatient surgical hospital provided the service is provided by:

1. A vendor currently providing services in Virginia;

2. A vendor not currently providing services who can demonstrate that the proposed unit can provide at least 750 procedures annually at all sites served; or

3. An applicant who can demonstrate that the proposed unit can provide at least 750 procedures annually at all sites to be served.

C. Proposals for the expansion of services by existing vendors or providers of such services may be approved if it can be demonstrated that each existing unit owned or operated by that vendor or provider has provided a minimum of 750 procedures annually at all sites served by the vendor or provider.

D. A new or expanded lithotripsy service may be approved when the applicant is a consortium of hospitals or a hospital network, when a majority of procedures will be provided at sites or facilities owned or operated by the hospital consortium or by the hospital network.

Surgical services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

Part IX
Organ Transplant

12VAC5-230-500. Accessibility Need for new service.

A. Organ transplantation services should be accessible within two hours driving time one way, under normal conditions, of 95% of Virginia's population. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a [ health ] planning district, exclusive of [ procedure rooms, ] dedicated cesarean section rooms, operating rooms designated exclusively for cardiac surgery, procedures rooms or VDH-designated trauma services, shall be determined as follows:

	FOR = ((ORV/POP) x (PROPOP)) x AHORV
	1600

Where:

ORV = the sum of total inpatient and outpatient general purpose operating room visits in the [ health ] planning district in the most recent [ three five ] years for which general purpose operating room utilization data has been reported by VHI; and

POP = the sum of total population in the [ health ] planning district as reported by a demographic entity as determined by the commissioner, for the same [ three year five-year ] period as used in determining ORV.

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

AHORV = the average hours per general purpose operating room visit in the [ health ] planning district for the most recent year for which average hours per general purpose operating room visits have been calculated as reported by VHI.

FOR = future general purpose operating rooms needed in the [ health ] planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room available 40 hours per week, 50 weeks per year.

B. Providers of organ transplantation services should facilitate access to pre- and post-transplantation services needed by patients residing in rural locations by establishing part-time satellite clinics Projects involving the relocation of existing [ general purpose ] operating rooms within a [ health ] planning district may be authorized when it can be reasonably documented that such relocation will [ : (i) ] improve the distribution of surgical services within a [ health ] planning district by making services available within 30 minutes driving time one way under normal conditions of 95% of the planning district's population; (ii) result in the provision of the same surgical services at a lower cost to surgical patients in the health planning district; or (iii) optimize the number of operations in the health planning district that are performed on an outpatient basis ].

12VAC5-230-510. Availability Staffing.

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Proposals to expand existing transplantation programs shall demonstrate that existing organ transplantation services comply with all applicable Medicare program coverage criteria. Surgical services should be under the direction or supervision of one or more qualified physicians.

Part VI
Inpatient Bed Requirements

12VAC5-230-520. Minimum utilization; minimum survival rate; service proficiency; systems operations Travel time.

A. Proposals to establish or expand organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number of transplants required by organ system is:

Kidney	30
Pancreas or kidney/pancreas	12
Heart	17
Heart/Lung	12
Lung	12
Liver	21
Intestine	2

Performance of minimum transplantation volumes does not indicate a need for additional transplantation capacity or programs.

B. Preference will be given to expansion of successful existing services, either by enabling necessary increases in the number of organ systems being transplanted or by adding transplantation capability for additional organ systems, rather than developing additional programs that could reduce average program volume.

C. Facilities should demonstrate that they will achieve and maintain minimum transplant patient survival rates. Minimum one-year survival rates, listed by organ system, are:

Kidney	95%
Pancreas or kidney/pancreas	90%
Heart	85%
Heart/Lung	60%
Lung	77%
Liver	86%
Intestine	77%

D. Proposals to add additional organ transplantation services should demonstrate at least two years successful experience with all existing organ transplantation systems.

E. All physicians that perform transplants should be board-certified by the appropriate professional examining board, and should have a minimum of one year of formal training and two years of experience in transplant surgery and post-operative care.

Inpatient beds should be within 30 minutes driving time one way under normal conditions of 95% of the population of a [ health ] planning district [ using a mapping software as determined by the commissioner ].

Part X
Miscellaneous Capital Expenditures

12VAC5-230-530. Purpose Need for new service.

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other parts of the SMFP addressing changes in bed or service capacity used in the COPN review process.

A. No new inpatient beds should be approved in any [ health ] planning district unless:

1. The resulting number of beds for each bed category contained in this article does not exceed the number of beds projected to be needed for that [ health ] planning district for the fifth planning horizon year; and

2. The average annual occupancy based on the number of beds in the [ health ] planning district for the relevant reporting period is:

a. 80% at midnight census for medical/surgical or pediatric beds;

b. 65% at midnight census for intensive care beds.

B. For proposals to convert under-utilized beds that require a capital expenditure of $15 million or more, consideration may be given to such proposal if:

1. There is a projected need in the applicable category of inpatient beds; and

2. The applicant can demonstrate that the average annual occupancy of the converted beds would meet the utilization standard for the applicable bed category by the first year of operation.

For the purposes of this part, "underutilized" means less than 80% average annual occupancy for medical/surgical or pediatric beds, when the relocation involves such beds and less than 65% average annual occupancy for intensive care beds when relocation involves such beds.

12VAC5-230-540. Project need Need for medical/surgical beds.

All applications involving the expenditure of $5 million dollars or more by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

The number of medical/surgical beds projected to be needed in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for the medical/surgical beds for the [ health ] planning district using the formula:

BUR = (IPD/PoP) x 1,000

Where:

BUR = the bed use rate for the [ health ] planning district.

IPD = the sum of total inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient day data has been reported by VHI; and

PoP = the sum of total population [ greater than ] 18 years of age [ and older ] in the [ health ] planning district for the same [ three five ] years used to determine IPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of medical/surgical beds needed for the [ health ] planning district in five years from the current year using the formula:

ProBed = ((BUR x ProPop)/365)/0.80

Where:

ProBed = The projected number of medical/surgical beds needed in the [ health ] planning district for five years from the current year.

BUR = the bed use rate for the [ health ] planning district determined in subdivision 1 of this section.

ProPop = the projected population [ greater than ] 18 years of age [ and older ] of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of medical/surgical beds that are needed in the [ health ] planning district for the five planning horizon years as follows:

NewBed = ProBed – CurrentBed

Where:

NewBed = the number of new medical/surgical beds that can be established in a [ health ] planning district, if the number is positive. If NewBed is a negative number, no additional medical/surgical beds should be authorized for the [ health ] planning district.

ProBed = the projected number of medical/surgical beds needed in the [ health ] planning district for five years from the current year determined in subdivision 2 of this section.

CurrentBed = the current inventory of licensed and authorized medical/surgical beds in the [ health ] planning district.

12VAC5-230-550. Facilities expansion Need for pediatric beds.

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion are inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

The number of pediatric beds projected to be needed in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for pediatric beds for the [ health ] planning district using the formula:

PBUR = (PIPD/PedPop) x 1,000

Where:

PBUR = The pediatric bed use rate for the [ health ] planning district.

PIPD = The sum of total pediatric inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient days data has been reported by VHI; and

PedPop = The sum of population under [ 19 18 ] years of age in the [ health ] planning district for the same [ three five ] years used to determine PIPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of pediatric beds needed to the [ health ] planning district in five years from the current year using the formula:

ProPedBed = ((PBUR x ProPedPop)/365)/0.80

Where:

ProPedBed = The projected number of pediatric beds needed in the [ health ] planning district for five years from the current year.

PBUR = The pediatric bed use rate for the [ health ] planning district determined in subdivision 1 of this section.

ProPedPop = The projected population under [ 19 18 ] years of age of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of pediatric beds needed within the [ health ] planning district for the fifth planning horizon year as follows:

NewPedBed – ProPedBed – CurrentPedBed

Where:

NewPedBed = the number of new pediatric beds that can be established in a [ health ] planning district, if the number is positive. If NewPedBed is a negative number, no additional pediatric beds should be authorized for the [ health ] planning district.

ProPedBed = the projected number of pediatric beds needed in the [ health ] planning district for five years from the current year determined in subdivision 2 of this section.

CurrentPedBed = the current inventory of licensed and authorized pediatric beds in the [ health ] planning district.

12VAC5-230-560. Renovation or modernization Need for intensive care beds.

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent three-year period.

The projected need for intensive care beds in a [ health ] planning district shall be computed as follows:

1. Determine the use rate for ICU beds for the [ health ] planning district using the formula:

ICUBUR = (ICUPD/Pop) x 1,000

Where:

ICUBUR = The ICU bed use rate for the [ health ] planning district.

ICUPD = The sum of total ICU inpatient days in the [ health ] planning district for the most recent [ three five ] years for which inpatient day data has been reported by VHI; and

Pop = The sum of population [ greater than ] 18 years of age [ or older for adults or under 18 for pediatric patients ] in the [ health ] planning district for the same [ three five ] years used to determine ICUPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of ICU beds needed for the [ health ] planning district, including bed availability for unscheduled admissions, five years from the current year using the formula:

ProICUBed = ((ICUBUR x ProPop)/365)/0.65

Where:

ProICUBed = The projected number of ICU beds needed in the [ health ] planning district for five years from the current year;

ICUBUR = The ICU bed use rate for the [ health ] planning district as determine in subdivision 1 of this section;

ProPop = The projected population [ greater than ] 18 years of age [ or older for adults or under 18 for pediatric patients ] of the [ health ] planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of ICU beds that may be established or relocated within the [ health ] planning district for the fifth planning horizon planning year as follows:

NewICUB = ProICUBed – CurrentICUBed

Where:

NewICUBed = The number of new ICU beds that can be established in a [ health ] planning district, if the number is positive. If NewICUBed is a negative number, no additional ICU beds should be authorized for the [ health ] planning district.

ProICUBed = The projected number of ICU beds needed in the [ health ] planning district for five years from the current year as determined in subdivision 2 of this section.

CurrentICUBed = The current inventory of licensed and authorized ICU beds in the [ health ] planning district.

12VAC5-230-570. Equipment Expansion or relocation of services.

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

A. Proposals to relocate beds to a location not contiguous to the existing site should be approved only when:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The number of beds to be moved off-site is taken out of service at the existing facility;

4. The off-site replacement of beds results in:

a. A decrease in the licensed bed capacity;

b. A substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or

c. Generally improved operating efficiency in the applicant's facility or facilities; and

5. The relocation results in improved distribution of existing resources to meet community needs.

B. Proposals to relocate beds within a [ health ] planning district where underutilized beds are within 30 minutes driving time one way under normal conditions of the site of the proposed relocation should be approved only when the applicant can demonstrate that the proposed relocation will not materially harm existing providers.

Part XI
Medical Rehabilitation

12VAC5-230-580. Accessibility Long-term acute care hospitals (LTACHs).

Comprehensive inpatient rehabilitation services should be available within 60 minutes driving time one way, under normal conditions, of 95% of the population of the planning region.

A. LTACHs will not be considered as a separate category for planning or licensing purposes. All LTACH beds remain part of the inventory of inpatient hospital beds.

B. A LTACH shall only be approved if an existing hospital converts existing medical/surgical beds to LTACH beds or if there is an identified need for LTACH beds within a [ health ] planning district. New LTACH beds that would result in an increase in total licensed beds above 165% of the average daily census for the [ health ] planning district will not be approved. Excess inpatient beds within an applicant's existing acute care facilities must be converted to fill any unmet need for additional LTACH beds.

C. If an existing or host hospital converts existing beds for use as LTACH beds, those beds must be delicensed from the bed inventory of the existing hospital. If the LTACH ceases to exist, terminates its services, or does not offer services for a period of 12 months within its first year of operation, the beds delicensed by the host hospital to establish the LTACH shall revert back to that host hospital.

If the LTACH ceases operation in subsequent years of operation, the host hospital may reacquire the LTACH beds by obtaining a COPN, provided the beds are to be used exclusively for their original intended purpose and the application meets all other applicable project delivery requirements. Such an application shall not be subject to the standard batch review cycle and shall be processed as allowed under Part VI (12VAC5-220-280 et seq.) of the Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations.

D. The application shall delineate the service area for the LTACH by documenting the expected areas from which it is expected to draw patients.

E. A LTACH shall be established for 10 or more beds.

F. A LTACH shall become certified by the Centers for Medicare and Medicaid Services (CMS) as a long-term acute care hospital and shall not convert to a hospital for patients needing a length of stay of less than 25 days without obtaining a certificate of public need.

1. If the LTACH fails to meet the CMS requirements as a LTACH within 12 months after beginning operation, it may apply for a six-month extension of its COPN.

2. If the LTACH fails to meet the CMS requirements as a LTACH within the extension period, then the COPN granted pursuant to this section shall expire automatically.

12VAC5-230-590. Availability Staffing.

A. The number of comprehensive and specialized rehabilitation beds needed in a health planning region will be projected as follows:

((UR x PROJ. POP.)/365)/.90

Where UR = the use rate expressed as rehabilitation patient days per population in the health planning region as reported in the most recent "Industry Report for Virginia Hospitals and Nursing Facilities" published by Virginia Health Information; and

PROJ.POP. = the most recent projected population of the health planning region three years from the current year as published by the Virginia Employment Commission.

B. No additional rehabilitation beds should be authorized for a health planning region in which existing rehabilitation beds were utilized at an average annual occupancy of less than 90% in the most recently reported year.

Preference will be given to the development of needed rehabilitation beds through the conversion of underutilized medical/surgical beds.

C. Notwithstanding subsection A of this section, the need for proposed inpatient rehabilitation beds will be given consideration when:

1. The rehabilitation specialty proposed is not currently offered in the health planning region; and

2. A documented basis for recognizing a need for the service or beds is provided by the applicant.

Inpatient services should be under the direction or supervision of one or more qualified physicians.

Part VII
Nursing Facilities

12VAC5-230-600. Staffing Travel time.

Medical rehabilitation facilities should have full-time medical direction by a physiatrist or other physician with a minimum of two years experience in the proposed specialized inpatient medical rehabilitation program.

A. Nursing facility beds should be accessible within 30 minutes driving time one way under normal conditions to 95% of the population in a [ health ] planning district [ using mapping software as determined by the commissioner ].

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. [ Consideration will Preference may ] be given to proposals that improve geographic access and reduce travel time to nursing facilities within a [ health ] planning district.

Part XII
Mental Health Services

Article 1
Psychiatric and Substance Abuse Disorder Treatment Services

12VAC5-230-610. Accessibility Need for new service.

A. Acute psychiatric, acute substance abuse disorder treatment services, and intermediate care substance abuse disorder treatment services should be available within 60 minutes driving time one way, under normal conditions, of 95% of the population.

B. Existing and proposed acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment service providers shall have established plans for the provision of services to indigent patients which include, at a minimum: (i) the minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients; (ii) the minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation; (iii) the minimum number of unreimbursed patient days to be provided to local community services boards; and (iv) a description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

C. Proposed acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment service providers shall have formal agreements with their identified community services boards that: (i) specify the number of charity care patient days that will be provided to the community service board; (ii) describe the mechanisms to monitor compliance with charity care provisions; (iii) provide for effective discharge planning for all patients, including return to the patients place of origin or home state if not Virginia; and (iv) consider admission priorities based on relative medical necessity.

D. Providers of acute psychiatric, acute substance abuse disorder treatment, and intermediate care substance abuse disorder treatment services serving large geographic areas should establish satellite outpatient facilities to improve patient access, where appropriate and feasible.

A. A [ health ] planning district should be considered to have a need for additional nursing facility beds when:

1. The bed need forecast exceeds the current inventory of beds for the [ health ] planning district; and

2. The average annual occupancy of all existing and authorized Medicaid-certified nursing facility beds in the [ health ] planning district was at least 93%, excluding the bed inventory and utilization of the Virginia Veterans Care Centers.

Exception: When there are facilities that have been in operation less than three years in the [ health ] planning district, their occupancy can be excluded from the calculation of average occupancy if the facilities [ has had ] an annual occupancy of at least 93% in one of its first three years of operation.

B. No [ health ] planning district should be considered in need of additional beds if there are unconstructed beds designated as Medicaid-certified. This presumption of ‘no need' for additional beds extends for three years [ or the date on the certificate, whichever is longer, for the unconstructed beds from the issuance date of the certificate ].

C. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85)

Where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP64 = The population aged 0 to 64 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP69 = The population aged 65 to 69 projected for the [ health ] planning district three years from the current year as most recently published by the a demographic program as determined by the commissioner.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP74 = The population aged 70 to 74 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP79 = The population aged 75 to 79 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP84 = The population aged 80 to 84 projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the [ health ] planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP85+ = The population aged 85 and older projected for the [ health ] planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

[ Planning Health planning ] district bed need forecasts will be rounded as follows:

[ Planning Health Planning ] District Bed Need	Rounded Bed Need
1-29	0
30-44	30
45-84	60
85-104	90
105-134	120
135-164	150
165-194	180
195-224	210
225+	240

Exception: When a [ health ] planning district has:

1. Two or more nursing facilities;

2. Had an average annual occupancy rate in excess of 93% for the most recent two years for which bed utilization has been reported to VHI; and

3. Has a forecasted bed need of 15 to 29 beds, then the bed need for this [ health ] planning district will be rounded to 30.

D. No new freestanding nursing facilities of less than 90 beds should be authorized. However, consideration may be given to a new freestanding facility with fewer than 90 nursing facility beds when the applicant can demonstrate that such a facility is justified based on a locality's preference for such smaller facility and there is a documented poor distribution of nursing facility beds within the [ health ] planning district.

E. When evaluating the [ capital ] cost of a project, consideration may be given to projects that use the current methodology as determined by the Department of Medical Assistance Services.

F. [ Consideration Preference ] may be given to [ proposals to projects that ] replace outdated and functionally obsolete facilities with modern facilities that result in the more cost-efficient resident services in a more aesthetically pleasing and comfortable environment.

12VAC5-230-620. Availability Expansion of services.

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROJ.POP. = the projected population of the planning district five years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-80, no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

However, consideration will be given to the addition of acute psychiatric or acute substance abuse disorder beds by existing medical care facilities in planning districts with an excess supply of beds when such additions can be justified on the basis of facility-specific utilization or geographic remoteness, i.e., driving time of 60 minutes or more, one way under normal conditions, to alternate acute care facilities. If the facility with the institutional need for beds is part of a hospital network, underutilized beds at the other facilities within the network should be relocated to the facility with the institutional need if possible.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.80

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROJ.POP. = the projected population of the planning district five years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

E. Preference will be given to the development of needed acute psychiatric and intermediate substance abuse disorder treatment beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and to have contractual agreements to serve populations served by Community Services Boards, whether through conversion of underutilized general hospital beds or development of new beds.

F. The number of intermediate care substance disorder abuse treatment beds needed in a planning district with existing intermediate care substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the planning district expressed as the average intermediate care substance abuse disorder treatment patient days per population reported for the most recent three-year period; and

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

G. Subject to the provisions of 12VAC5-230-80, no additional intermediate care substance abuse disorder treatment beds should be authorized for a planning district with existing intermediate care substance abuse disorder treatment beds if the existing inventory of such beds is greater than the need identified. No beds in facilities operated by DMHMRSAS will be included in the inventory of intermediate care substance abuse disorder beds.

However, consideration will be given to the addition of intermediate care substance abuse disorder treatment beds by existing medical care facilities in planning districts with an excess supply of beds when such addition can be justified on the basis of facility-specific utilization or geographic remoteness, i.e., driving time of 60 minutes or more one way under normal conditions, to alternate acute care facilities. If the facility with the institutional need for beds is part of a hospital network, underutilized beds at the other facilities within the network should be relocated to the facility with the institutional need if possible.

H. No existing intermediate care substance abuse disorder treatment beds should be relocated from one site to another unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing intermediate care substance abuse disorder treatment providers to continue to provide historic levels of service to indigent patients.

I. The number of intermediate care substance abuse disorder treatment beds needed in a planning district without existing intermediate care substance abuse disorder treatment beds will be determined as follows:

((UR x PROJ.POP.)/365)/.75

Where UR = the use rate of the health planning region in which the planning district is located expressed as the average intermediate care substance abuse disorder treatment patient days per population reported for the most recent three-year period;

PROJ.POP. = the projected population of the planning district three years from the current year as reported in the most recent published projections of the Virginia Employment Commission.

J. Preference will be given to the development of needed intermediate care substance abuse disorder treatment beds through the conversion of underutilized general hospital beds.

Proposals to increase existing nursing facility bed capacity should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 93% in the relevant reporting period as reported to VHI.

Note: Exceptions will be considered for facilities that operated at less than 93% average annual occupancy in the most recent year for which bed utilization has been reported when the facility [ has a rehabilitative or other specialized care program causing a short average length of stay resulting in offers short stay services causing ] an average annual occupancy lower than 93% for the facility.

Article 2
Mental Retardation

12VAC5-230-630. Availability Continuing care retirement communities.

The establishment of new ICF/MR facilities should not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility.

6. The proposed new facility is consistent with the current DMHMRSAS Comprehensive Plan and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities (CCRC) will be considered when:

[ 1. The facility is registered with the State Corporation Commission as a continuing care provider pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia; ]

[ 1. 2. ] The [ total ] number of [ new or additional beds plus any existing ] nursing facility beds [ operated by the continuing care provider does not exceed 20% of the continuing care provider's total existing or planned independent living and adult care residence requested in the initial application does not exceed the lesser of 20% of the continuing care retirement community's total number of beds that are not nursing home beds or 60 beds ];

[ 2. 3. ] The [ proposed beds are necessary to meet existing or reasonably anticipated obligations to provide care to present or prospective residents of the continuing care facility number of new nursing facility beds requested in any subsequent application does not cause the continuing care retirement community's total number of nursing home beds to exceed 20% of its total number of beds that are not nursing facility beds ]; and

[ 3. The applicant certifies that :

a. The CCRC has, or will have, a qualified resident assistance fund and that the facility will not rely on federal and state public assistance funds for reimbursement of the proposed beds;

b. The continuing care contract or disclosure statement, as required by § 38.2-4902 of the Code of Virginia, has been filed with the State Corporation Commission and that the commission has deemed the contract or disclosure statement in compliance with applicable law; and

c. Only continuing care contract holders residing in the CCRC as independent living residents or adult care residents or who is a family member of a contract holder residing in a non-nursing facility portion of the CCRC will be admitted to the nursing facility unit after the first three years of operation.

4. The continuing care retirement community has established a qualified resident assistance policy. ]

12VAC5-230-640. Continuity; integration Staffing.

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary. Nursing facilities shall be under the direction or supervision of a licensed nursing home administrator and staffed by licensed and certified nursing personnel qualified as required by law.

Part VIII
Lithotripsy Service

12VAC5-230-650. Acceptability Travel time.

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations of the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services. Lithotripsy services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the health planning region [ using mapping software as determined by the commissioner ].

Part XIII
Perinatal Services

Article 1
Criteria and Standards for Obstetrical Services

12VAC5-230-660. Accessibility Need for new service.

Obstetrical services should be located within 30 minutes driving time one way, under normal conditions, of 95% of the population in rural areas and within 30 minutes driving time one way, under normal conditions, in urban and suburban areas.

A. [ Consideration Preference ] may be given to [ a project that establishes ] new renal or orthopedic lithotripsy services [ established ] at a new facility through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, [ provided and ] the facility has referred at least two appropriate patients per week, or 100 appropriate patients annually, for the relevant reporting period to other facilities for either renal or orthopedic lithotripsy services.

B. A new renal lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 750 renal lithotripsy procedures annually.

C. A new orthopedic lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 500 orthopedic lithotripsy procedures annually.

12VAC5-230-670. Availability Expansion of services.

A. Proposals to establish new obstetrical services in rural areas should demonstrate that obstetrical volumes within the travel times listed in 12VAC5-230-660 will not be negatively affected.

B. Proposals to establish new obstetrical services in urban and suburban areas should demonstrate that a minimum of 2,500 deliveries will be performed annually by the second year of operation and that obstetrical volumes of existing providers located within the travel times listed in 12VAC5-230-660 will not be negatively affected.

C. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service will be given preference over the addition of new services or the expansion of single service providers.

A. Proposals to [ increase expand ] renal lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 750 procedures annually at all sites served by the vendor or provider.

B. Proposals to [ increase expand ] orthopedic lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 500 procedures annually at all sites served by the vendor or provider.

12VAC5-230-680. Continuity Adding or expanding mobile lithotripsy services.

A. Perinatal service capacity should be developed and sized to provide routine newborn care to infants delivered in the associated obstetrics service, and shall have the capability to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The application should identify the primary and secondary neonatal special care center nearest the proposed service and provide travel time one way, under normal conditions, to those centers.

A. Proposals for mobile lithotripsy services should demonstrate that, for the relevant reporting period, at least 125 procedures were performed and that the proposed mobile unit will not reduce the utilization of existing machines in the [ health ] planning region.

B. Proposals to convert a mobile lithotripsy service to a fixed site lithotripsy service should demonstrate that, for the relevant reporting period, at least 430 procedures were performed and the proposed conversion will not reduce the utilization of existing providers in the [ health ] planning district.

Article 2
Neonatal Special Care Services

12VAC5-230-690. Accessibility Staffing.

Neonatal special care services should be located within an average of 45 minutes driving time one way, under normal conditions, in urban and suburban areas of hospitals providing general-level newborn services. Lithotripsy services should be under the direction or supervision of one or more qualified physicians.

Part IX
Organ Transplant

12VAC5-230-700. Availability Travel time.

A. Existing neonatal special care units located within the travel times listed in 12VAC5-230-660 should achieve 65% average annual occupancy before new services can be added to the planning region Organ transplantation services should be accessible within two hours driving time one way under normal conditions of 95% of Virginia's population [ using mapping software as determined by the commissioner ].

B. Preference will be given to the expansion of existing services rather than the creation of new services Providers of organ transplantation services should facilitate access to pre and post transplantation services needed by patients residing in rural locations be establishing part-time satellite clinics.

12VAC5-230-710. Neonatal services Need for new service.

The application should identify the service area, levels of service, and capacity of the current general-level newborn service hospitals to be served within the identified area.

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Performance of minimum transplantation volumes as cited in 12VAC5-230-720 does not indicate a need for additional transplantation capacity or programs.

12VAC5-230-720. Transplant volumes; survival rates; service proficiency; systems operations.

A. Proposals to establish organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number transplants of required by organ system is:

Kidney	30
Pancreas or kidney/pancreas	12
Heart	17
Heart/Lung	12
Lung	12
Liver	21
Intestine	2

Note: Any proposed pancreas transplant program must be a part of a kidney transplant program that has achieved a minimum volume standard of 30 cases per year for kidney transplants as well as the minimum transplant survival rates stated in subsection B of this section.

B. Applicants shall demonstrate that they will achieve and maintain at least the minimum transplant patient survival rates. Minimum one-year survival rates listed by organ system are:

Kidney	95%
Pancreas or kidney/pancreas	90%
Heart	85%
Heart/Lung	70%
Lung	77%
Liver	86%
Intestine	77%

12VAC5-230-730. Expansion of transplant services.

A. Proposals to [ increase expand ] organ transplantation services shall demonstrate at least two years successful experience with all existing organ transplantation systems at the hospital.

B. [ Consideration will Preference may ] be given to [ expanding successful existing services through increases in a project expanding ] the number of organ systems being transplanted [ at a successful existing service ] rather than developing new programs that could reduce existing program volumes.

12VAC5-230-740. Staffing.

Organ transplant services should be under the direct supervision of one or more qualified physicians.

Part X
Miscellaneous Capital Expenditures

12VAC5-230-750. Purpose.

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other service specific parts addressed elsewhere in this chapter.

12VAC5-230-760. Project need.

All applications involving the expenditure of $15 million or more by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

12VAC5-230-770. Facilities expansion.

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion is inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

12VAC5-230-780. Renovation or modernization.

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent five-year period.

12VAC5-230-790. Equipment.

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

Part XI
Medical Rehabilitation

12VAC5-230-800. Travel time.

Medical rehabilitation services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

12VAC5-230-810. Need for new service.

A. The number of comprehensive and specialized rehabilitation beds shall be determined as follows:

((UR x PROPOP)/365)/ [ .85 .80 ]

Where:

UR = the use rate expressed as rehabilitation patient days per population in the [ health ] planning district as reported by VHI; and

PROPOP = the most recent projected population of the [ health ] planning district five years from the current year as published by a demographic entity as determined by the commissioner.

B. Proposals for new medical rehabilitation beds should be considered when the applicant can demonstrate that:

1. The rehabilitation specialty proposed is not currently offered in the [ health ] planning district; and

2. There is a documented need for the service or beds in the [ health ] planning district.

12VAC5-230-820. Expansion of services.

No additional rehabilitation beds should be authorized for a [ health ] planning district in which existing rehabilitation beds were utilized with an average annual occupancy of less than [ 85% 80% ] in the most recently reported year.

[ Exception: Consideration Preference ] may be given to [ expanding a project to expand ] rehabilitation beds [ through the conversion of by converting ] underutilized medical/surgical beds.

12VAC5-230-830. Staffing.

Medical rehabilitation facilities should be under the direction or supervision of one or more qualified physicians.

Part XII
Mental Health Services

Article 1
Acute Psychiatric and Acute Substance Abuse Disorder Treatment Services

12VAC5-230-840. Travel time.

Acute psychiatric and acute substance abuse disorder treatment services should be available within 60 minutes driving time one way under normal conditions of 95% of the population [ using mapping software as determined by the commissioner ].

12VAC5-230-850. Continuity; integration.

A. Existing and proposed acute psychiatric and acute substance abuse disorder treatment providers shall have established plans for the provision of services to indigent patients that include:

1. The minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients;

2. The minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation;

3. The minimum number of unreimbursed patient days to be provided to local community services boards; and

4. A description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

B. Proposed acute psychiatric and acute substance abuse disorder treatment providers shall have formal agreements with the appropriate local community services boards or behavioral health authority that:

1. Specify the number of patient days that will be provided to the community service board;

2. Describe the mechanisms to monitor compliance with charity care provisions;

3. Provide for effective discharge planning for all patients, including return to the patient's place of origin or home state if not Virginia; and

4. Consider admission priorities based on relative medical necessity.

C. Providers of acute psychiatric and acute substance abuse disorder treatment serving large geographic areas should establish satellite outpatient facilities to improve patient access where appropriate and feasible.

12VAC5-230-860. Need for new service.

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a [ health ] planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the [ health ] planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-70, no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a [ health ] planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

[ Consideration Preference ] may also be given to the addition of acute psychiatric or acute substance abuse beds dedicated for the treatment of geriatric patients in [ health ] planning districts with an excess supply of beds when such additions are justified on the basis of the specialized treatment needs of geriatric patients.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a [ health ] planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the health planning region in which the [ health ] planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROPOP = the projected population of the [ health ] planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

E. Preference [ will may ] be given to the development of needed acute psychiatric beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and that have contractual agreements to serve populations served by community services boards, whether through conversion of underutilized general hospital beds or development of new beds.

Article 2
Mental Retardation

12VAC5-230-870. Need for new service.

The establishment of new ICF/MR facilities with more than 12 beds shall not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility;

6. The proposed new facility will have a maximum of 20 beds and is consistent with any plan of the Department of Mental Health, Mental Retardation and Substance Abuse Sservices and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

12VAC5-230-880. Continuity; integration.

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary.

12VAC5-230-890. Compliance with licensure standards.

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations for the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services.

Part XIII
Perinatal [ and Obstetrical ] Services

Article 1
Criteria and Standards for Obstetrical Services

12VAC5-230-900. Travel time.

Obstetrical services should be located within 30 minutes driving time one way under normal conditions of 95% of the population of the [ health ] planning district [ using mapping software as determined by the commissioner ].

12VAC5-230-910. Need for new service.

[ A. ] No new obstetrical services should be approved unless the applicant can demonstrate that, based on the population and utilization of current services, there is a need for such services in the [ health ] planning district without [ significantly ] reducing the utilization of existing providers in the [ panning health planning ] district.

[ B. Applications to improve existing obstetrical services, and to reduce costs through consolidation of two obstetrical services into a larger, more efficient service should be given preference over establishing new services or expanding single service providers. ]

12VAC5-230-920. Continuity.

A. Perinatal service capacity, including service availability for unscheduled admissions, should be developed to provide routine newborn care to infants delivered in the associated obstetrics service, and shall be able to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The proposal shall identify the primary and secondary neonatal special care center nearest the proposed service shall provide transport one-way to those centers.

12VAC5-230-930. Staffing.

Obstetric services should be under the direction or supervision of one or more qualified physicians.

Article 2
Neonatal Special Care Services

12VAC5-230-940. Travel time.

A. Intermediate level neonatal special care services should be located within 30 minutes driving time one way under normal conditions of hospitals providing general level new born services [ using mapping software as determined by the commissioner ].

B. Specialty and subspecialty neonatal special care services should be located within 90 minutes driving time one way under normal conditions of hospitals providing general or intermediate level newborn services [ using mapping software as determined by the commissioner ].

12VAC5-230-950. Need for new service.

[ A. ] No new level of neonatal service shall be offered by a hospital unless that hospital has first obtained a COPN granting approval to provide each such level of service.

[ B. Preference will be given to the expansion of existing services, rather than to the creation of new services. ]

12VAC5-230-960. Intermediate level newborn services.

A. Existing [ neonatal special care units providing ] intermediate level newborn services as designated in 12VAC5-410-443 [ , located within 30 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new intermediate level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing intermediate Intermediate ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of six bassinets [ , stations or beds ].

C. No more than four bassinets [ , stations and beds ] for intermediate level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

12VAC5-230-970. Specialty level newborn services.

A. Existing [ neonatal special care units providing ] specialty level newborn services as designated in 12VAC5-410-443 [ located within 90 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new specialty level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing specialty Specialty ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets [ , stations or beds. A station shall equal one bed ].

C. No more than four bassinets [ , stations and beds ] for specialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

D. Proposals to establish specialty level [ neonatal special care ] services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing specialty level [ neonatal special care newborn service ] providers located within the travel time listed in 12VAC5-230-940 will not be [ significantly ] reduced.

12VAC5-230-980. Subspecialty level newborn services.

A. Existing [ neonatal special care units providing ] subspecialty level newborn services as designated in 12VAC5-410-443 [ located within 90 minutes driving time one way under normal conditions ] should achieve 85% average annual occupancy before new subspecialty level newborn services can be added to the [ health ] planning region.

B. [ Neonatal special care units providing subspecialty Subspecialty ] level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets [ , stations or beds. A station shall equal one bed ].

C. No more than four bassinets [ , stations and beds ] for subspecialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each [ health ] planning region [ , with a bassinet or station counting as the equivalent of one bed ].

D. Proposals to establish subspecialty level [ neonatal special care newborn ] services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing subspecialty level [ neonatal special care newborn ] providers located within the travel time listed in 12VAC5-230-940 will not be [ significantly ] reduced.

12VAC5-230-990. Neonatal services.

The application shall identify the service area and the levels of service of all the hospitals to be served by the proposed service.

12VAC5-230-1000. Staffing.

All levels of neonatal special care services should be under the direction or supervision of one or more qualified physicians as described in 12VAC5-410-443.