The original parties to this contested case action were Petitioner Trident Medical Center, LLC (“Trident), Petitioner-Intervenor CareAlliance Health Services (“CareAlliance”), and Respondents South Carolina Department of Health and Environmental Control (“DHEC” or “Department”) and HealthFirst, LLC (“HealthFirst”) (collectively “Respondents”). Trident and CareAlliance contested DHEC's decision to grant a Certificate of Need (“CON”) to HealthFirst for the construction of an Ambulatory Surgery Center (“ASC”) with two (2) operating rooms specializing in the delivery of ophthalmic surgery, to be located in the Essex Farms Medical Complex in the West Ashley area of Charleston, South Carolina. The Administrative Law Judge Division (“ALJD”) has subject matter jurisdiction over contested cases arising from CON disputes. See S.C. Code Ann. §§ 44-7-210(D)(2), 1-23-310(2), and 1-23-600(B) (Supp. 2002). The contested case hearing was held November 19--22, 2002.

Pursuant to the “South Carolina Certificate of Need and Health Facilities Licensure Act” (“CON Act”), HealthFirst filed its CON application on April 18, 2001, for DHEC review under the 1999 State Health Plan (“SHP”). By letter dated December 11, 2001, DHEC notified HealthFirst of its decision to grant its CON application, prompting Trident’s timely request for a contested case hearing with the Department. CareAlliance did not file its request for a contested case hearing with the Department within the statutory time frame set forth in S.C. Code Ann. § 44-7-210(d) (Supp. 2002) and its case was subsequently dismissed by this Court on March 14, 2002. On February 12, 2001, CareAlliance moved to intervene as a party on the basis that it was an “affected person” as defined by S.C. Code Ann §44-7-130 (Supp. 2002) in the matter of Trident v. DHEC and HealthFirst, Docket No. 02-ALJ-07-0026-CC, which this Court granted on March 14, 2002. After fully participating in the hearing, and after submitting a proposed order, CareAlliance entered into a consent settlement agreement with HealthFirst, LLC, Trident and DHEC. I signed that order on June 11, 2003, dismissing CareAlliance as a party.^[1]

During the review process, DHEC identified the criteria most important in evaluating the application and applied those criteria, along with the standards set forth in the State Health Plan, before reaching its decision. The Department approved the application and stated that its decision was based on the following:

1. The proposal is consistent with the standards for ambulatory surgery facilities as outlined in the 1999 S.C. Health Plan;

2. The need for the proposed project has been demonstrated;

3. The proposed project appears to be financially feasible, based on the information available; and

4. The project has substantial physician support and community support.

After consideration of the evidence and arguments, I find HealthFirst’s application meets the criteria for approval established by DHEC pursuant to the CON Act and regulations. Therefore, DHEC’s decision is affirmed, and HealthFirst’s application for a CON is granted. Any issues raised or presented in the proceeding of this matter which are not addressed are specifically denied.

APPLICABLE LAW

This case is governed by the CON Act and the regulations promulgated thereto, 24A Reg. 61-15 (Supp. 2002). CON Act provides:

(C) The department may not issue a Certificate of Need unless an application complies with the State Health Plan, Project Review Criteria, and other regulations. Based on project review criteria and other regulations, which must be identified by the department, the department may refuse to issue a Certificate of Need even if an application complies with the State Health Plan. In the case of competing applications, the department shall award a Certificate of Need, if appropriate, on the basis of which, if any, most fully complies with the requirements, goals, and purposes of this article and the State Health Plan, Project Review Criteria, and the regulations adopted by the department. S.C. Code § 44-7-210(C) (Supp. 2002).

DHEC Reg. 61-15, § 802 lists general criteria applicable to all CON applications. As required by § 44-7-220(c) DHEC identified the following as the § 802 criteria ranked in order of priority to be applied in evaluating HealthFirst’s application. See DHEC Ex. 1, p. 291.

1. Compliance with the State Health Plan

2. Community Need Documentation-2a, 2b, 2c, 2e

Distribution (Accessibility)- 3c, 3d, 3e, 3g

3. Adverse Effect on Other Facilities-23a

4. Cost Containment-16c

Projected Revenues-6a, 6b, 6c

Projected Expenses-7

5. Financial Feasability-15

The numbers beside each criterion indicate the subsections of 24A S.C. Code Ann. Regs. 61-15 §802 which the Department found applicable to HealthFirst’s application. Trident contends that the Department’s decision to approve HealthFirst’s application is erroneous because it fails to meet the following criteria selected by the Department:

1.                Section 802(1)-Need: The proposal shall not be approved unless it is in compliance with the State Health Plan.

2.                Section 802(2)(a)-Community Need Documentation: The target population should be clearly identified as to size, distribution, and socioeconomic status (if applicable).

3.                Section 802(2)(e)-Current and/or projected utilization should be sufficient to justify the expansion or implementation of the proposed service.

4.                Section 802(3)(a)-Distribution (Accessibility): Duplication and modernization of services must be justified. Unnecessary duplication of services and unnecessary modernization of services will not be approved.

5.                Section 802(15)-Financial Feasibility: The applicant must have projected both the immediate and long term financial feasibility of the proposed project. Such projection should be reasonable and based upon accepted accounting procedures.

6.                Section 802(16)(c)-Cost Containment: The impact upon the applicant’s cost to provide services and the applicant’s patient charges should be reasonable. The impact of the proposed project upon the cost and charges of the other providers of similar services should be considered if the data is available.

7.                Section 802(20)(a)-Staff Resources: The applicant should have a reasonable plan for the provision of all required staff (physicians, nursing, allied health and support staff, etc).

The State Health Plan contains these requirements specific to Ambulatory Surgery Centers:

1. The applicant must document need for the expansion of or the addition of an ambulatory surgical facility. The existing resources must be considered and documentation presented as to why the existing resources are not adequate to meet the needs of the community.

2. There must be support from the physicians in the area to be served. The applicant must define the proposed service area and/or provide patient origin information on the current facility.

3. The applicant must discuss the impact that the proposed ambulatory surgical facility or expansion will have upon existing facilities.

4. The applicant must document where the potential patients for the facility will come from and where they are currently being served.

5. All new Certificate of Need approvals by the Department will not restrict the specialties of ambulatory surgery centers. Ambulatory surgery centers may be open to all surgical specialties or provide services to a single specialty, depending on their capabilities. For an ambulatory surgery center approved to perform only endoscopy procedures, another Certificate of Need would be required before the Center could provide other surgical specialties.

6. All proposed ambulatory surgical facilities, other than those restricted to endoscopy procedures, must have a minimum of two (2) operating rooms. DHEC Ex. 2, p. II-97-98.

A CON contested case proceeding is limited to the issues which were presented to, or considered by the Department during its review and decision-making process. S.C. Code Ann. § 44-7-210(E) (Supp. 2002). Further, the evidence in a contested case proceeding is limited to the facts available to DHEC during the review process. Marlboro Park Hospital v. Department of Health and Environmental Control, 98-ALJ-07-0734.

ISSUES RAISED

Trident’s Prehearing Statement raised general grounds for appeal of DHEC’s decisions to

grant the CON to HealthFirst. Those grounds are:

8.                  Did DHEC err in determining there is a need for HealthFirst’s proposed Ambulatory Surgery Center in the Tri-county area?

9.                  Did DHEC err in determining that the impact of HealthFirst’s proposed Ambulatory Surgery Center will not adversely affect existing facilities in the Tri-county service area?

10.              Did DHEC err in determining that HealthFirst’s proposed project is financially feasible?

11.              Was the DHEC record insufficient to support the Department’s staff decision to issue the CON?

FINDINGS OF FACT

Having carefully considered all the testimony, exhibits, and arguments presented at the hearing in this case and taking into account the credibility of the witnesses and accuracy of the evidence, I find the following facts were established by a preponderance of the evidence:

1. HealthFirst filed its application for a CON on April 18, 2001 for the construction

of a state of the art Ambulatory Surgery Center with two operating rooms specializing in ophthalmic surgery. The Ambulatory Surgery Center will be located in the Essex Farms Medical Complex in the West Ashley area of Charleston, South Carolina. DHEC Ex. 1, p.7.

2. The proposed service area for HealthFirst facility includes Charleston,

Dorchester, and Berkeley counties. (“Tri-county” area). DHEC Ex. 1, pp. 5. Trident and CareAlliance argued that the service area only included the twelve ZIP Code areas listed in the application. However, Trident and CareAlliance have overlooked that portion of the State Health Plan that provides that the facility should identify where its current patients come from. DHEC Ex. 2, SHP, p. II-109. There is no existing facility and the zip code data was from two of the existing physicians’ patient practice data. Even Trident and CareAlliance’s expert acknowledged that the HealthFirst application defines the service area as the Tri-county area. Tr. p. 205, ll. 20-21, Day 2. I find that the contention of Petitioner that the HealthFirst project would serve only twelve zip codes within the Tri-County area to be without evidentiary support. I find that the testimony and evidence presented by HealthFirst on the projected population growth, and growth of ophthalmic procedures of the Tri-County area is more credible and is supported by accredited statistics.

3. The CON application was filed under the 1999 State Health Plan.

4. HealthFirst is a South Carolina limited liability company. Its owners are Dr. John

Boatwright, Dr. Paul Herring, and Dr. Thomas Mather. DHEC Ex. 1, p. 10. Each of the physicians is an ophthalmologist and practices ophthalmic surgery. Dr. Boatwright specializes in cataract surgery and pediatric ophthalmic surgery, including strabismus surgery, and is the only pediatric ophthalmic surgeon in private practice in the Tri-county area. The other pediatric surgeons are employed by the Medical University of South Carolina. Dr. Herring specializes in cataract and YAG laser surgery. Tr., Nov. 21, p. 80, 5; 90, 15. Dr. Mather specializes in ocular plastic surgery and is the only ocular plastic surgeon certified by the American Society of Ophthalmic Plastic and Reconstructive Surgery in the Tri-county area. Tr., Nov. 20, p. 288, 25; p. 292, ll 10-13.

5. HealthFirst will lease the Ambulatory Surgery Center facility from Prime Sight Real

Estate, LLC, a South Carolina limited liability company owned by Drs. Boatwright and Herring. DHEC Ex. 1, p. 11.

6. In order to perform surgery at a healthcare facility, a physician must have staff

privileges at the facility. Tr. p. 250, l. 25 thru 251, l. 8, Day 2.

7. Trident is a limited liability company owned by the Health Care Company HCA

which operates under the laws of the State of South Carolina and offers ambulatory surgery services in the Tri-county area.

8. Trident is an acute care hospital located in the northern part of Charleston County.

No outpatient ophthalmic surgery is performed at Trident. Trident Surgery Center (TSC) is located on the Trident campus and is owned jointly by Trident and certain surgeons. Tr. p. 16 and 137, Day 1. Prior to May 1999, ophthalmic surgery was performed at Trident Surgery Center.

9. Trident Eye Surgery Center (TESC) is also located on the Trident campus and

was acquired in 1999 by a limited liability joint venture composed of Trident and a group of ophthalmologists. HealthFirst Ex. 9. Trident Eye Surgery Center operated as a free standing ophthalmic surgery center prior to its purchase by the joint venture in 1999. On November 26, 2001, during the HealthFirst CON application review period, DHEC approved TESC’s application to change from a single specialty to a multi-specialty surgery center.

10. The Department approved HealthFirst’s application for a CON for the

construction of an Ambulatory Surgery Center with two (2) rooms on December 11, 2001.

11. Pursuant to S.C. Code Ann. §44-7-210(D)(1), Trident filed a request for staff

reconsideration of the HealthFirst decision with the Department on December 21, 2001. The Department denied the request for reconsideration on the ground that Trident failed to document or otherwise demonstrate “good cause” as defined in 24A S.C. Code Ann. Reg. 61-15 § 103.2.

12. The proposed HealthFirst facility will be licensed by the Department as a multi-

specialty Ambulatory Surgery Center as required by the CON regulations and State Health Plan, but by design and use it will be used for ophthalmic care only. Under this CON, HealthFirst will only be able to acquire medical equipment for ophthalmic procedures.

13. Trident presented Ms. Leah Etheridge, the director of Trident Surgery Center and

Trident Eye Surgery Center as a fact witness. Tr. p. 130, 22, Day 1. CareAlliance presented Ms. Carrie Livingston, the director of the outpatient surgery department of Roper, as a fact witness. Tr. p. 77, Day 2. Trident and CareAlliance jointly presented Mr. Robert Limyanski as an expert witness. Mr. Limyanski was proffered and designated as an expert in the areas of economics. Tr. p. 16, 176, Day 2. Trident also called as witnesses Mr. Dyson Scott and Ms. Lynne Kerrison, CPA. Mr. Scott assisted HealthFirst in the preparation of its CON application. Tr. p. 31, Day 2. Ms. Kerrison, a certified public accountant licensed in South Carolina, prepared the pro forma budget for the HealthFirst Application. Tr. p. 161, Day 2.

14. HealthFirst called Dr. John Boatwright, Dr. Paul Herring and Dr. Thomas Mather

as fact witnesses, and called Daniel J. Sullivan as its expert witness. Mr. Sullivan was proffered and designated as an expert in the areas of health planning, healthcare finance and financial feasibility, and certificate of need process in South Carolina. Tr. p. 128, ll. 9-18, Day 3, Nov. 21.

15. The Department called Mr. Rodney Bowman and Mr. Joel Grice as its expert

witnesses. Mr. Bowman is a Project Reviewer II for the Department and was the staff person assigned to review the HealthFirst CON application. Tr. p. 50, 4 Nov. 22. Mr. Bowman was also the staff person responsible for reviewing the Trident Eye Surgery Center CON application to change from a single specialty ophthalmic surgery center to a multi-specialty center. Mr. Joel Grice has been the Director, Bureau of Health Facilities and Services since December 2000. Prior to that, he was the Director of the Certification of Need Program for a number years. Based upon their training and work experience within the Department, Mr. Bowman and Mr. Grice have specialized knowledge and expertise regarding the evaluation of CON applications and the application of the CON Act and regulations.

16. I find that the testimony presented by Drs. Boatwright, Herring, and Mather, Mr.

Dan Sullivan, Mr. Rodney Bowman, and Mr. Joel Grice was highly credible.

I. Need for HealthFirst

1. The Tri-county service area is the only metropolitan statistical area as defined by the U.S. Census Bureau without a freestanding surgery center dedicated to ophthalmic procedures.

2. CareAlliance’s witness, Ms. Livingston, testified that 80 percent utilization is the

number at which CareAlliance and its affiliated facilities plan for expansion. Tr. p. 128, ll. 16-22. Mr. Limyanski testified that appropriate utilization for an ambulatory surgery center is 80 percent and that 80 percent is a number used industry-wide. Tr. p. 213, Day 3. Mr. Sullivan (Tr., p. 137, ll. 7-17, Day 3, Nov. 21) and Mr. Grice (Tr. 213, 13 Nov. 22) both testified that 80 percent utilization is the point at which, for health care planning purposes, facilities look at the need to expand an existing facility. Prior to and during the HealthFirst CON application Review Period, CareAlliance facilities filed CON applications utilizing 80 percent utilization as the optimum utilization for an Ambulatory Surgery Center or hospital facilities. See HealthFirst Exs. 1 (CON application to transfer Roper West Ashley to East Cooper); 3 (Roper Berkeley ASC); and 5 (construction and renovation of St. Francis).

3. Each applicant submitting a CON application to DHEC must certify to the

Department that the information contained in the CON application is true and accurate to the best of its knowledge. In its application, HealthFirst so certified.

4. The standard of care in South Carolina and the nation for ophthalmic surgery is to

schedule surgery no later than 1:00 p.m. to 2:00 p.m. due to the age and physical condition of most ophthalmic surgical patients. Tr., p. 316. Patients must be NPO, i.e., they cannot eat or drink for twelve (12) hours before surgery. Tr., p. 316, ll. 1-25. Nov. 20. Not eating until late in the afternoon can create health problems for both younger and elderly patients and for patients with health problems. Most cataract patients are elderly and have other health problems such as diabetes or heart problems. Due to the scheduling problems at both the CareAlliance facilities and the Trident facilities, the physicians are having difficulty maintaining this standard of care for their patients.

5. It is also the standard of care for ophthalmic surgeons to utilize block scheduling

where they have access to “flip flop” of operating rooms. Block scheduling with “flip flop” refers to the ability of the surgeon to have two surgical rooms operating simultaneously. The surgeon can operate in one room, while a nurse is in the adjacent room preparing the next patient for surgery. The physician is able to move easily between the rooms with little loss of time. The staff is more easily able to focus on the tasks and patients at hand, because they are scheduled in the same area in back to back blocks in two adjacent operating rooms. Block scheduling with “flip flopping” of operating rooms allows ophthalmic surgeons and their staff to treat patients more efficiently and safely. Tr. p. 305, l. 12 through 306, l. 4, Day 2; Tr. p. 29, l. 9 through 30, l. 1, Day 3. There was no evidence that any current outpatient surgery facility or department in the Tri-county area has the capacity to provide block scheduling with “flip flopping” of operating rooms to any of the ophthalmic surgeons in the area. Drs. Boatwright, Herring and Mather testified that such block scheduling is not available in the Tri-county area. Tr., pp. 307, 19 Day 2; Tr. p. 35, 81, Day 3. I find that HealthFirst demonstrated a need for the proposed project because, in the Tri-County area, there is not sufficient available block time in existing outpatient operating rooms, in either hospitals or free standing Ambulatory Surgery Centers, for ophthalmic surgeons to meet the demands of their patients for ophthalmic procedures.

6. The Trident Eye Surgery Center rooms are general outpatient surgery rooms which

not accurately represent the available capacity for outpatient ophthalmic surgery in the Tri-county area. The capacity calculations on all outpatient surgery ORs in the Tri-county area were made without regard to whether they were equipped for ophthalmic surgery. This inclusion significantly overstated the capacity for ophthalmic surgery in the area, thereby understating the need for additional ophthalmic surgical capacity.

7. Ophthalmic surgery is a specialized, highly technical, precise surgery that

requires special equipment for its performance. Cataract surgery requires the simultaneous use of both a phaco emulsification machine (phaco) and a microscope. Tr. p. 210, 11. 5-15, Day 3, Nov. 21. Unless an Operating Room is equipped with both a phaco and a microscope, it has no capacity for cataract surgery-- the most common form of ophthalmic surgery.

8. Ocular plastic surgery also requires very specialized medical equipment. In order

to assure availability of the proper equipment and to have the necessary familiarity with the surgical equipment, Dr. Mather, the ocular plastic surgeon, is currently forced to carry his personal medical equipment to the facilities in which he operates. Tr. p. 306-307, Day 3.

9. There are only seven ORs in the Tri-county area that are equipped for ophthalmic

surgery. DHEC Ex. 1, p. 343. Two of those, at Trident Eye Surgery Center, do not have general anesthesia and cannot be utilized for all ophthalmic surgery.

10. The capacity for a freestanding Ambulatory Surgery Center or hospital-based

Operating Room ranges between 1000 and 1250 procedures per year. Tr. p. 140, ll. 8-18, Day 3, Nov. 21. In determining capacity for ambulatory surgery ORs in the Tri-county area, CareAlliance utilized a capacity number of 1500 cases per Operating Room. DHEC Ex. 1, p. 325. The capacity numbers per Operating Room provided to DHEC during the Review Period are contrary to those certified to by Roper West Ashley Surgery Center, Roper Berkeley Ambulatory Surgery, Bon Secours St. Francis and Roper Hospital in their respective CON applications. HealthFirst Exs. 1, 3, 5 and 7. I find that the range of 1000 to 1250 procedures per Operating Room per year is credible and supported by the testimony and exhibits.

11. HealthFirst also demonstrated a need for the proposed project by providing a chart

that compared the availability of ophthalmic surgical suites in freestanding Ambulatory Surgery Centers in the Tri-County area to other metropolitan areas of South Carolina. This chart demonstrated that there is an ophthalmic surgical suite available per 64,000 citizens in the Richland-Lexington county areas, and per 61,000 citizens in the Greenville-Spartanburg county areas. In the Tri-County area, there is an ophthalmic surgical suite available per 137,000 citizens. (DHEC Exhibit 1, p. 342).

12. Trident Eye Surgery Center submitted an application to DHEC to convert from a

single specialty to a multi-specialty facility. Trident Eye Surgery Center certified to DHEC that the information contained in its application was true and accurate to the best of its knowledge. HealthFirst Ex. 9, p. 3. Trident Eye Surgery Center filed its CON application in part to offset any loss of utilization it would suffer in the event the HealthFirst application was approved. HealthFirst Ex. 9, p. 767.

13. Trident Eye Surgery Center does not provide general anesthesia. There are certain

ophthalmic cases or procedures that can only be done with general anesthesia. Dr. Boatwright, the pediatric ophthalmologist, testified that the lack of general anesthesia at Trident Eye Surgery Center limited his ability to perform operations at Trident Eye Surgery Center:

Well, I can't do any pediatric cases there, and I can't do any adult strabismus cases. Then, in terms of cataract patients, there are cases or patients that need general anesthesia for cataract surgery, and often those are mentally challenged patients and we see quite a few patients from the Coastal Center. Dr. Herring sees more than I do. But those patients often need general anesthesia for cataract surgery. Tr. p. 33, ll. 3-13, Day 3.

Dr. Mather testified that his ocular plastic surgery also required general anesthesia or heavy sedation and he could rarely operate in a facility like Trident Eye Surgery Center that did not have general anesthesia. Tr. p. 291, ll. 15-24. Mr. Limyanski also testified that there are ophthalmic procedures that can only be performed under general anesthesia.

14. Trident Eye Surgery Center has physical limitations with regard to patient

privacy and the ability to move patients on a surgical bed from the Operating Room to the recovery area. Tr. pp. 34, l. 23 through p. 36, l. 2, Day 3, Nov. 21. Although Trident Eye Surgery Center does allow surgeons to have block scheduling time, it does not have the capability to allow Operating Room “flip flopping.” Tr. p. 36, ll. 3-10, Day 3, Nov. 21.

15. In its CON application for the conversion of Trident Eye Surgery Center

to multi-specialty, Trident stated that at Trident Surgery Center, “scheduling is sometimes booked up two weeks ahead of the needed date.” See Transcript Day 1, p. 232. During the review period, Trident Eye Surgery Center had two operating rooms and thirteen ophthalmic surgeons on staff.

16. Additionally, the Trident Eye Surgery Center CON application was filed to

shift outpatient surgery procedures from Trident Surgery Center, because of the significant growth at Trident Surgery Center, to Trident Eye Surgery Center. Trident Surgery Center had expanded hand surgery by 56 percent and pain management by 85 percent. Because Trident Surgery Center was being over-utilized, Trident Eye Surgery Center sought a CON from DHEC to convert from a single-specialty eye only surgery center to a multi-specialty surgery center. HealthFirst Ex. 9, p. 767.

17. Trident Surgery Center is a four-room multi-specialty Ambulatory Surgery

Center. Trident Surgery Center has only one phaco emulsification machine (“phaco”) and one microscope, which limits the number of rooms actually available, because both the phaco and the microscope have to be used simultaneously in order to perform cataract surgery. Tr. p. 219, ll. 5-15. In 1999, at the time Trident Eye Surgery Center was purchased, Trident Surgery Center generally shifted its ophthalmic surgery from Trident Surgery Center to Trident Eye Surgery Center. In 1999, Trident Surgery Center had 523 ophthalmic patients and in 2000 Trident Surgery Center had six (6) ophthalmology patients. See Transcript Day 1, p. 220-221. Trident Surgery Center was at or above 80 percent capacity when DHEC determined to grant the HealthFirst CON.

18. On August 6, 2001, during the HealthFirst CON application review period, the

CON application for the conversion of the Trident Eye Surgery Center from single-specialty facility to multi-specialty facility was submitted to DHEC, and approved on November 26, 2001. HealthFirst Ex. 9, p. 929. In addition to the need to transfer cases to Trident Eye Surgery Center to create additional capacity at Trident Eye Surgery Center, one of the reasons Trident requested that Trident Eye Surgery Center be converted from single-specialty was in anticipation of and to offset any loss of patient volume from the approval of HealthFirst’s CON application. HealthFirst Ex. 9, p. 767.

19. Roper Hospital is located on the peninsula in Charleston and has a separate

hospital based ambulatory surgery department (ASD) that consists of five general operating rooms and one minor procedure room. Roper’s ASD is equipped to perform ophthalmic procedures in only two rooms.

20. Roper West Ashley, located west of the Ashley River, is a freestanding surgery

center with four operating rooms. Only two are available and equipped to perform ophthalmic procedures. There is no capacity available at Roper West Ashley to “flip-flop” ORs.

21. In February 2001, Roper West Ashley filed a CON application requesting that

the Department allow it to relocate to Mt. Pleasant in the area east of the Cooper River. HealthFirst Ex. 1. Roper West Ashley certified in its application to DHEC that it was near capacity and would soon have to turn away patients. HealthFirst Ex. 1, p. 29. In August 2000, Roper sold a 49% interest in Roper West Ashley to a group of eight orthopedic surgeons. Tr. 83. HealthFirst Ex. 1, p.92. From the time of the purchase until the CON application was filed, utilization of orthopedic procedures increased 189 percent. HealthFirst Ex.1, p. 23. The CON application also informed DHEC that as the investor physicians continued to perform a larger percentage of their volume at the facility in which they had invested, the percentage of orthopedic cases would continue to increase. Tr. p. 87, ll. 15 thru p. 88, l. 3; HealthFirst Ex. 1, p. 86 through 88.

22. HealthFirst’s CON application noted the Roper West Ashley change of

ownership included orthopedic surgeons and the difficulty the surgeons were experiencing in obtaining surgical time as a result of that change. DHEC Ex. 1, pp. 16, 127, and 312. Drs. Mather, Herring, and Boatwright testified that due to the dramatic increase in orthopedic surgery at Roper West Ashley and the higher level of reimbursement for such procedures, the ophthalmic physicians were not given available time. See Transcript Day 2, p. 85-90.

23. Roper West Ashley’s CON application further demonstrates the need for a

dedicated ophthalmic Ambulatory Surgery Center in the Tri-county area. The Roper West Ashley CON application certified that its facility should be relocated: 1) to accommodate the overall growth of outpatient surgery; and 2) to modernize the center to facilitate improved patient flow and privacy. Transcript Day 2, p. 90.

24. Roper West Ashley certified in its application that there was, “limited space

available for pre-operative and post-operative care [which] has limited the Ambulatory Surgery Center to using only three of its four operating rooms on a regular basis.” According to the Roper West Ashley application, there are also problems with patient flow, which will be exacerbated by the increased volume. See Transcript Day 2, p. 91-92. The Roper West Ashley application further certified to DHEC that it would soon be near peak operating capacity. HealthFirst Ex. 1, p. 29.

25. St. Francis does not have dedicated inpatient and outpatient surgical

departments; it utilizes the same OR’s for both. Of the eight operating rooms at St. Francis, only two have the capability to handle ophthalmic procedures. Tr. p. 56, ll.4-9, Day 2, Nov. 20. In the Roper Berkeley CON application submitted to DHEC, CareAlliance certified to DHEC that the operating rooms at St. Francis were above the optimum utilization rate of 80 percent and that the capacity crunch was only expected to worsen as the Charleston area continued to grow and expand. There is no block scheduling time available at St. Francis for the HealthFirst Physicians. Tr. p. 66, l. 12 through 67, l. 15. During the Review Period, Roper Berkeley, located in Moncks Corner, had not yet opened. In the Roper Berkeley application, CareAlliance represented to DHEC that due to the capacity levels of 80 percent or more at both Roper and St. Francis, the purpose of the application was to free up operating capacity at both facilities. CareAlliance also represented that absent a transfer of ambulatory volume, expansion would be necessary at both Roper and St. Francis in the immediate future to accommodate surgical demands. HealthFirst Ex. 3. Nowhere in the Roper Berkeley application did the facility propose to perform ophthalmic procedures.

26. At the time of the HealthFirst CON review process, the Colleton Surgery

Center had two operating rooms with one phaco machine and only one room available for ophthalmic surgery.

27. At the time of the HealthFirst CON review process, the Health South Surgery

Center had four operating rooms with only one room available for ophthalmic surgery. See Transcript Day 1, p. 255-256.

28. There are significant problems with existing facilities in terms of patient access,

in coordination of benefits, and timely appointments. DHEC Ex. 1, p. 9.

29. The HealthFirst application received significant community support, including

local, state and federal elected officials, and physician support. DHEC Ex. 1 and HealthFirst Ex. 29. There was no opposition from any physician or surgeon in the Tri-county area, including those surgeons who had ownership interests in Trident Eye Surgery Center, Trident Surgery Center, HealthSouth and Roper West Ashley. DHEC Ex. 1.

30. There is significant and rapid growth in the Tri-county area of people 65 and

older. DHEC Ex. 1. The vast majority of patients that have cataract surgery are in the 65 and older population.

31. In order for ophthalmic surgeons to practice at the current facilities available

in the Tri-county area, they need specialized equipment and staff, which is not available at the current facilities in the Tri-county area. See Transcript Day 2, p. 294.

32. I find that locating the Ambulatory Surgery Center in the west Ashley area of

Charleston County makes it centrally located to the population of the Tri-county area, and that there is a need for a freestanding Ambulatory Surgery Center in the Tri-county area dedicated to ophthalmic surgery.

II. Adverse Impact

1. The HealthFirst facility will have an open medical staff, but will be limited in

the number of surgeries it can schedule in the two operating rooms, and the fact that it is only approved to acquire ophthalmic medical equipment under this CON application, as well as its total project cost.

2.                  The short-term adverse impact on existing facilities in the Tri-county area because of the HealthFirst facility will be minimal. There will be no long-term negative impact on Trident or CareAlliance or the other facilities in the Tri-county area that provide outpatient ophthalmic surgery.

3. In a letter to DHEC, Leah Etheridge admitted that even if HealthFirst operated as a multi-specialty surgery center that the impact would be “marginal” on the utilization rates of Trident Surgery Center. Ms. Etheridge also stated that if HealthFirst only operated as a single-specialty center, it would not have any effect on Trident Surgery Center. See DHEC Ex. 1, p. 266 and Transcript, Day 1, p. 222.

4. There will be no adverse impact on either Trident Surgery Center or Trident Eye Surgery Center based on the new HealthFirst CON, because both are multi-specialty facilities in orthopedics, pain management, and hand surgery. See Transcript Day 1, p. 243. Trident submitted to DHEC in its CON projected additional income at the end of 2002 of $490,000 and by December 2005, an additional income of $707,000. See Transcript Day 1, p. 245.

5. Trident did not provide DHEC with any empirical data either during the Review Period or during the hearing demonstrating the economic effect that HealthFirst might have on either Trident Surgery Center or Trident Eye Surgery Center. At the project review meeting, Trident provided DHEC with calculations purporting to show how many cases would be lost assuming that, in addition to the cases lost from Drs. Boatwright, Herring and Mather, Drs. Savage, Newland, and Richards transferred their cases to HealthFirst. However, the DHEC record demonstrated that Drs. Newland and Richards specifically stated that they did not plan to change their practice patterns and that their patients would continue to determine where they wanted to go. DHEC Ex. 1, pp. 462. See Transcript Day 1, p. 250-252.

6. Trident’s witness, Leah Etheridge, admitted that, in presenting the information for Trident at the project review committee meeting, she used data from internal reports, but did not furnish those reports to DHEC. She did not use data from the Joint Annual Reports (JARs), which is a public document. (Transcript, Vol. II, pp. 5-8). Therefore, the information presented to DHEC during the project review committee meeting indicated only 2789 procedures during the year 2000, where the JARs indicated that Trident Eye Surgery Center actually had performed 2843 procedures. (DHEC Exhibit 1, pp. 321, 345).

7. The testimony of both Petitioner’s and Respondents' experts about the method to compute accurate utilization of outpatient operating rooms concluded that the base number to use for an outpatient operating room was between 1000-1250 per year, and not the 1500 used by CareAlliance in its information presented to DHEC during the project review committee meeting. (Transcript, Vol. II, pp. 93-94; pp. 215-217; Vol. III, pp. 140-141).

8. I find that, because Trident Eye Surgery Center has only two operating rooms, the calculations by CareAlliance on the current utilization for Trident Eye Surgery Center at the time of the DHEC review of the HealthFirst application were incorrect. Using the 1500 maximum number of cases per operating room, even though disputed by both Petitioner’s and Respondents' experts, demonstrates that the Trident Eye Surgery Center utilization, before expanding to a multi-specialty license was at 92.9%, using the number of procedures provided by Trident, or 94.7%, using the numbers of procedures in the Trident Eye Surgery Center JAR for the year 2000.

9. Ms. Etheridge testified that she was unfamiliar with the utilization projections used by her own expert and HealthFirst's expert. Instead she used an estimation of utilization using data from an internal report not provided to DHEC or during the hearing, and estimated that the utilization of Trident Eye Surgery Center was at 40%. Transcript, Vol. I, pp. 164-166.

10.              Trident and CareAlliance’s expert did not testify that the HealthFirst facility would have an adverse impact on any of the existing facilities.

11. There will be significant growth in the ophthalmological surgery arena, which would help to offset any short term loss of patients from Trident or CareAlliance. Tr. p. 200, l. 19 through 201, l. 1.

III. Financial Feasibility

1. The average patient revenue per case projected by the HealthFirst facility is

$1037.00 as contained in DHEC’s Exhibit #1, page 149. This figure is reasonable based on the evidence and testimony presented.

2. No information was submitted to DHEC during the CON Review Period that

the HealthFirst project was not financially feasible. The only reliable probative and substantial evidence presented at the hearing regarding the financial feasibility of the project was presented by Ms. Kerrison, a CPA called by Petitioner.

3. The first pro forma budget submitted by HealthFirst utilized the cash method

of accounting. DHEC requested that HealthFirst submit its pro forma budget based on the accrual method of accounting required by GAAP. The financials were submitted in accordance with GAAP. See Transcript Day 2, p. 162-164.

4. The HealthFirst project is financially feasible based on the statement of Lynne Kerrison, the accountant who prepared the financials of the HealthFirst application, who stated that the assumptions provided to her were all reasonable and came from reliable management sources. Ms. Kerrison testified that she was prepared to stand behind the numbers in the pro forma budget. Tr. p.165, ll. 15-24, Day 2.

IV. Insufficient Record

1. One of the Petitioner’s primary complaints is that HealthFirst did not

sufficiently define the service area. The CON application is clear that the service area is the Tri-county area-- Charleston, Dorchester, and Berkley counties.

2. There were scrivener’s errors in the HealthFirst CON application as initially

submitted, due to the inadvertent submission of the rough draft of the CON rather than the final application. Transcript Day 2, p. 32-33. HealthFirst sent a letter to Rodney Bowman, the DHEC employee who reviewed the project, correcting any mistakes and providing any information not included before the application was deemed complete. See Transcript Day 2, p. 33; DHEC Ex. 1, p. 386-391.

3. HealthFirst put into the DHEC file information it could gather regarding the

prices other facilities charge for similar procedures. DHEC Ex. 1, p. 19. Due to the fact that pricings of services (other than the reimbursement mandated by Medicare) is confidential information, such information is difficult to gather. HealthFirst’s application contained the basic Medicare reimbursement guide for primary ophthalmic procedures which formed the basis of a part of the pro forma budget. DHEC Ex. 1, p. 78-80.

4. HealthFirst specifically incorporated by reference and requested that DHEC do

the same, all of the information submitted by Trident in the Trident Eye Surgery Center CON application to become a multi-specialty Ambulatory Surgery Center and CareAlliance’s CON applications filed by its subsidiaries, Roper West Ashley, Roper Berkeley and St. Francis-Bon Secours. DHEC Ex. 1, p. 351 and 391. DHEC had not only all of the data included in the HealthFirst CON application, but also all of the information and demographic data included in the referenced CON applications.

5. The HealthFirst application provided DHEC with demographic data from the

State Demographer, State Budget and Control Board. DHEC Ex. 1, pp, and contained numerous letters of support from community and medical personnel. HealthFirst Ex. 29.

6. The HealthFirst application discussed the potential effect of the Ambulatory

Surgery Center on existing providers when it provided DHEC with the number of cases it estimated would be lost from Trident Eye Surgery Center, HealthSouth, Roper West Ashley and East Cooper Medical Center. DHEC Ex. 1, pp. 127-129 and 344..

7. DHEC conducted a project review meeting on the CON application on

December 16, 2002. The HealthFirst physicians spoke to the need for the facility and the problems with existing facilities. The oral presentations at the project review meeting are part of the record considered by DHEC.

8. Mr. Grice testified that no application is perfect and that by the time the

application was complete, it met the requirements of Reg. 61-15, including the standards set forth in the State Health Plan. Tr. pp. 255, l14, through 256, l. 8.

CONCLUSIONS OF LAW

Based upon the foregoing Findings of Fact, I conclude as a matter of law, the following:

1. The South Carolina Administrative Law Judge Division has jurisdiction over CON contested case proceedings pursuant to S.C. Code Ann. § 44-7-210 and § 1-23-600(B)(Supp. 2002).

2. In a CON contested case, the Petitioner bears the burden of proving its case by a preponderance of the evidence. S.C. Code Ann. § 44-7-210(E) (Supp. 2002); see also Anonymous v. State Board of Medical Examiners, 329 S.C. 371, 496 S.E.2d 17 (1998); Nat’l Health Corp. v. SCDHEC, 298 S.C. 373, 380 S.E.2d 841 (1989).

3. Preponderance of the evidence is defined as, “the greater weight of the evidence.” See State v. Grooms, 343 S.C. 248, 540 S.E.2d 99 (2000). Thus, the Petitioner bears the burden of proving by a preponderance of the evidence that HealthFirst’s CON application does not meet the legal requirements for approval under the CON Act. Trident has not proved by a preponderance of the evidence that:

a. DHEC’s decision to approve the HealthFirst CON is contrary to the laws of the State of South Carolina;

b. HealthFirst did not demonstrate need for the project;

c. HealthFirst did not adequately demonstrate that the project is financially feasible; and

d. DHEC’s decision was based upon incorrect information regarding existing services in the service area;

4. The Administrative Law Judge is the fact finder in this matter for purposes of administrative and judicial review and does not sit in an appellate capacity. Brown v. S.C. Dep't of Health and Envtl. Control, 348 S.C. 507, 560 S.E.2d 410 (2002). Evidence of allegations must be sufficient and probative of the matter to be proven. Coleman v. Palmetto State Life Ins. Co., 241 S.C. 384, 128 S.E. 2d 699 (1962). As trier of fact, The ALJ is not compelled to accept an expert’s testimony, but may give it the weight and credibility as the ALJ determines it deserves. Florence County Dep’t. of Social Serv. v. Ward, 310 S.C. 69, 425 S.E. 2d 61 (1992).

5. It is appropriate to give due consideration to the Department's CON staff’s utilization of its specialized knowledge and expertise in the application of the CON Act and CON regulations. See S.C. Code Ann. § 1-23-330(4) (1986 and Supp. 2002). However, the Department's Board, and not the Department's CON staff, is the policymaker for the Department and thus possesses the authority to interpret its regulatory and statutory provisions.

6. The purposes of the CON Act are “to promote cost containment, prevent unnecessary duplication of health care facilities and services, guide the establishment of health facilities and services which will best serve public needs, and ensure that high quality services are provided in health facilities in this State.” S.C. Code Ann. § 44-7-120 (Supp. 2002). S.C. Code Ann. § 44-7-140 designates the Department of Health and Environmental Control as the sole agency for control and administration of the granting of Certificates of Need and licensure of health facilities and other activities necessary to be carried out under the Act. Furthermore, S.C. Code Ann. § 44-7-150(3) (Supp. 2002) mandates that the Department adopt substantive and procedural regulations considered necessary by the Department to carry out its duties under the CON Act.

7. An Administrative Law Judge's review of a DHEC administrative decision to grant a CON application is governed by S.C. Code Ann. § 44-7-210(E) (Supp. 2002), which provides, in pertinent part:

The department's proposed decision is not final until the completion of reconsideration of contested case proceedings.... The contested case hearing before the board or its designee is conducted as a contested case under the Administrative Procedures Act. The issues considered at the contested case hearing are limited to those presented or considered during the staff review and decision process. (emphasis added).

8. The Board has found, and I conclude as a matter of law, that DHEC can only consider those matters and information that were before it or publicly available to it during the Review Period. Marlboro Park Hospital v. DHEC, et al., May 8, 2001, aff’d by Judge Goode December 26, 2001, Motion for Reconsideration denied January 18, 2002, appeal pending at the S.C. Court of Appeals. The Administrative Procedures Act, “contemplates a straight-line agency process beginning with fact-finding and ending with judicial review; it does not contemplate an agency’s continuous re-initiation of investigation throughout the process.” Therefore, parties are prohibited from submitting new or additional facts for consideration at the hearing which were not part of the administrative record at the time of the initial staff decision. Long Term Care Foundation v. South Carolina Department of Health and Environmental Control and National Health Care, Docket No. 97-ALJ-07-0381-CC, and Milliken and Co. v. South Carolina Department of Labor, 275 S.C. 264, 267, 269 S.E.2d 763, 764 (1980). A decision is arbitrary if it is without a rational basis, is based alone on one's will and not upon any course of reasoning and exercise of judgement, is made at pleasure, without adequate determining principles, or is governed by no fixed rules or standards. Deese v. South Carolina State Board of Dentistry, 286 S.C. 182, 332 S.E.2d 539 (Ct. App. 1985); Physician Imaging Centers, Inc. v. South Carolina Department of Health and Environmental Control and Tricounty Radiology Associates, PA, Docket No. 95-ALJ-07-0540-CC

9. Because both Trident and CareAlliance offer outpatient surgery services to persons who reside in the Tri-county area, they are “affected persons” under S.C. Code Ann. § 44-7-130 (Supp. 2002) and S.C. Code Ann. Regs. 61-15 § 130(1)(Supp. 2002) with standing to request a contested case hearing of the Department’s decision to approve HealthFirst’s application for an Ambulatory Surgery Center with two operating rooms.

10. The purpose of the CON Act is to promote cost containment, prevent unnecessary duplication of health care facilities services, guide the establishment of health facilities and services which will best serve public needs, and ensure that high quality services are provided in health facilities in this State. S.C. Code Ann. § 44-7-120. Quality is defined as “superiority of kind;¼, Degree or grade of excellence.” The American Heritage Dictionary, 2^nd College Edition (1985). As a matter of law, high quality services are those services that meet the standard of care in ophthalmic surgery.

11. All decisions on CON applications must be made based on the State Health Plan in effect at the time an application is accepted. S.C. Code Ann. Reg. 61-15 §504. The 1999 South Carolina Health Plan was in effect when the application was accepted by the Department. Pursuant to S.C. Code Ann. Reg. 61-15 §202(B)(11) the proposed project demonstrates that it is needed or projected as necessary to meet identified need of the public. This demonstration shall address at a minimum identification of the target population, the degree of unmet need, projected utilization of the proposed facility, utilization of existing facilities and services. The applicant must use population statistics consistent with those generated by the State Demographer, State Budget and Control Board.

12. The Department may not issue a CON unless an application complies with the applicable State Health Plan, project review criteria, and other regulations. S.C. Code Ann. § 44-7-210(C) (Supp. 2002). The criteria applicable to HealthFirst’s CON application in this case are found in 23A S.C. Code Ann. Regs. 61-15.802

13. Although a project does not have to satisfy every applicable project review criterion in order to be approved, no project may be approved unless it is consistent with the State Health Plan. 24A S.C. Code Ann. Regs. 61-15, § 801(3) (Supp. 2002). The State Health Plan contained six (6) criteria that HealthFirst had to satisfy for DHEC to approve the CON. Criteria 5 and 6 were not contested, nor was that portion of criteria 2 that requires there be physician support in the area to be served.

14. The State Health Plan criterion 1 at page II-108 provides, “the applicant must document need for the expansion of or the addition of an ambulatory surgical facility. The existing resources must be considered and documentation presented as to why existing resources are not adequate to meet the needs of the community.”

15. “Need” is examined by considering resources already in the community along with a demonstration of why those resources cannot meet the demand being asserted. Edisto Surgery Center v. South Carolina Department of Health and Environmental Control, Docket No. 97-ALJ-07-0434-CC.

16. As a matter of law, the evidence and testimony presented by HealthFirst and DHEC regarding

the need for the addition of an ambulatory surgical facility dedicated to ophthalmic surgery providing standard of care services was more credible, reliable and probative. There was no evidence introduced at the hearing that block scheduling with the ability to “flip flop” rooms was not the standard of care in South Carolina and the United States.

17. The existing resources in the Tri-county area, including Trident, Trident Surgery Center,

Trident Eye Surgery Center, HealthSouth, Roper, Roper West Ashley, St. Francis, Roper Berkeley, Summerville Hospital or East Cooper Medical Center, do not have the capability to provide block scheduling with the ability to “flip flop” rooms.

18. HealthFirst’s expert’s testimony regarding the growth in the elderly population in the Tri-county area and the concomitant increase in ophthalmic surgery--particularly cataract surgery--was credible, reliable and probative. The testimony of HealthFirst’s expert and of the DHEC witnesses regarding the high utilization of the existing outpatient facilities in the Tri-county area is credible, reliable and probative.

19. In light of the reliable, probative and substantial evidence in the record regarding the projected growth of the aging population in the Tri-county area and Trident Eye Surgery Center’s conversion from a single specialty to a multi-specialty facility, HealthFirst adequately addressed the impact that its ASC would have on existing facilities. That impact is short-term and should be gone within two to three years. HealthFirst fulfilled the requirements of Criterion 1 of the State Health Plan.

20. Criterion 2 provides in contested part that the “applicant must define the proposed service and/or provide patient origin information on the current facility.” As a matter of law, since there is no “current facility” HealthFirst did not have to provide patient origin information to fulfill this criterion. HealthFirst fulfilled this criterion by defining the proposed service area as Berkeley, Charleston and Dorchester counties.

21. Criterion 3 provides that “the applicant must discuss the impact that the proposed ambulatory surgical facility or expansion will have upon the existing service providers.” As a matter of law, HealthFirst discussed the impact that its proposed ASC would have on existing providers when it projected the cases that would be lost to existing providers where the HealthFirst physicians currently operate.

22. As a matter of law, the HealthFirst ASC will be multi-specialty, but the CON must be implemented as approved, with the total project cost limited to the amount specified in its CON application. S.C. Code Ann. § 230(C). The CON approved two operating rooms and ophthalmic medical equipment only.

23. Criterion 4 of the State Health Plan provides that the “applicant must document where the potential patients for the facility will come from and where they are currently being served.” HealthFirst met this criterion when it identified how many patients would be lost from Trident Eye Surgery Center, Roper West Ashley, HealthSouth and East Cooper Regional Medical Center (i.e., where the patients are currently being treated). HealthFirst identified the fact that the remaining patients to be seen at its Ambulatory Surgery Center would come from growth in the population, based upon the demographic statistics from the State Budget and Control Board.

24. I find that the Petitioner has demonstrated by a preponderance of the evidence that HealthFirst’s proposed freestanding ambulatory surgery center dedicated to ophthalmology does not meet the requirements of criteria 1, 2, 3 and 4 of the State Health Plan or of S.C. Code Ann. Reg. 61-15 § 802.

25. HealthFirst’s proposed surgery center dedicated to ophthalmology meets the requirements of 24A S.C. Code Ann. Regs. 61-15.802(2)(e) because current and/or projected surgical utilization is sufficient to justify the implementation of its proposed services.

26. “Adverse impact” generally means a material decrease in the present or future use or occupancy rates of existing providers for like procedures. See 24A S.C. Code Ann. Regs. 61-15.802(23)(a) (Sup. 2002).

27. As a matter of law, based upon the aging of the population, the limitations on the existing facilities, the high utilization of the existing facilities providing ophthalmic surgery, the change in licensure of Trident Eye Surgery Center from a single to multi-specialty Ambulatory Surgery Center, there will be no material decrease in the present or future use or occupancy rates and there will be no long-term adverse effect on existing facilities which justify the denial of the HealthFirst CON.

28. Increased accessibility outweighs the minimal impact on the Petitioner. HealthFirst’s proposed ambulatory surgery center meets the requirements of the 1999 State Health Plan and 24A S.C. Code Ann. Regs. 61-15 § 802 (Supp. 2002)

29. In accordance with S.C. Code Ann. Reg. 61-15 § 802.15, the proposed HealthFirst facility is financially feasible.

30. The HealthFirst CON application, in conjunction with the DHEC CON file, the CON applications incorporated by reference, and the record provide sufficient information for DHEC to reach the conclusion it did to approve the project.

ORDER

Based on the foregoing Findings of Fact and Conclusions of Law,

IT IS HEREBY ORDERED that the DHEC decision to issue the CON to HealthFirst, LLC is AFFIRMED and the CON is GRANTED.

AND IT IS SO ORDERED.

________________________________

CAROLYN C. MATTHEWS

Administrative Law Judge

June13, 2003

Columbia, South Carolina