The Issue The issue is whether BayCare Long Term Acute Care Hospital, Inc.'s Certificate of Need Application No. 9753 and University Community Hospital's Certificate of Need Application No. 9754, both submitted to the Agency for Health Care Administration, should be approved.
Findings Of Fact LTCHs defined An LTCH is a medical facility which provides extended medical and rehabilitation care to patients with multiple, chronic, or clinically complex acute medical conditions. These conditions include, but are not limited to, ventilator dependency, tracheotomy care, total parenteral nutrition, long- term intravenous anti-biotic treatment, complex wound care, dialysis at bedside, and multiple systems failure. LTCHs provide an interdisciplinary team approach to the complex medical needs of the patient. LTCHs provide a continuum of care between short-term acute care hospitals and nursing homes, skilled nursing facilities (SNFs), or comprehensive medical rehabilitation facilities. Patients who have been treated in an intensive acute care unit at a short-term acute care hospital and who continue to require intensive care once stabilized, are excellent candidates for care at an LTCH. Included in the interdisciplinary approach is the desired involvement of the patient's family. A substantial number of the patients suitable for treatment in an LTCH are in excess of 65 years of age, and are eligible for Medicare. Licensure and Medicare requirements dictate that an LTCH have an average length of stay (ALOS) of 25 days. The Center for Medicare and Medicaid Services (CMS) reimburses for care received through the prospective payment system (PPS). Through this system, CMS reimburses the services of LTCHs separately from short-term acute care providers and other post acute care providers. The reimbursement rate for an LTCH under PPS exceeds that of other providers. The reimbursement rate for an LTCH is about twice that of a rehabilitation facility. The increased reimbursement rate indicates the increased cost due to the more intensive care required in an LTCH. The Agency The Agency is a state agency created pursuant to Section 20.42. It is the chief health policy and planning entity for the State of Florida. The Agency administers the Health Facility and Services Development Act found at Sections 408.031-408.045. Pursuant to Section 408.034, the Agency is designated as the single state Agency to issue, revoke, or deny certificates of need. The Agency has established 11 health service planning districts. The applications in this case are for facilities in District 5, which comprises Pinellas and Pasco counties. UCH UCH is a not-for-profit organization that owns and operates a 431-bed tertiary level general acute care hospital and a 120-bed acute care general hospital. Both are located in Hillsborough County. UCH also has management responsibilities and affiliations to operate Helen Ellis Hospital, a 300-bed hospital located in Tarpon Springs, and manages the 300-bed Suncoast Hospital. Both of these facilities are in Pinellas County. UCH also has an affiliation to manage the open heart surgery program at East Pasco Medical Center, a general acute care hospital located in Pasco County. As a not-for-profit organization, the mission of UCH is to provide quality health care services to meet the needs of the communities where it operates regardless of their patients' ability to pay. Baycare BayCare is a wholly-owned subsidiary of BayCare Healthsystems, Inc. (BayCare Systems). BayCare Systems is a not-for-profit entity comprising three members that operate Catholic Health East, Morton Plant Mease Healthcare, and South Florida Baptist. The facilities owned by these organizations are operated pursuant to a Joint Operating Agreement (JOA) entered into by each of the participants. BayCare Systems hospitals include Morton Plant Hospital, a 687-bed tertiary level facility located in Clearwater, Pinellas County; St. Joseph's Hospital, an 887-bed tertiary level general acute care hospital located in Tampa, Hillsborough County; St. Anthony's Hospital, a 407-bed general acute care hospital located in St. Petersburg, Pinellas County; and Morton Plant North Bay, a 120-bed hospital located in New Port Richey, Pasco County. Morton Plant Mease Health Care is a partnership between Morton Plant Hospital and Mease Hospital. Although Morton Plant Mease Healthcare is a part of the BayCare System, the hospitals that are owned by the Trustees of Mease Hospital, Mease Hospital Dunedin, and Mease Hospital Countryside, are not directly members of the BayCare System and are not signatories to the JOA. HealthSouth HealthSouth is a national company with the largest market share in inpatient rehabilitation. It is also a large provider of ambulatory services. HealthSouth has about 1,380 facilities across the nation. HealthSouth operates nine LTCHs. The facility that is the Intervenor in this case is a CMR located in Largo, Pinellas County. Kindred Kindred, through its parent company, operates LTCH facilities throughout Florida and is the predominant provider of LTCH services in the state. In the Tampa Bay area, Kindred operates three LTCHs. Two are located in Tampa and one is located in St. Petersburg, Pinellas County. The currently operating LTCH in District 5 that may be affected by the CON applications at issue is Kindred-St. Petersburg. Kindred-St. Petersburg is a licensed 82-bed LTCH with 52 private beds, 22 semi-private beds, and an 8-bed intensive care unit. It operates the array of services normally offered by an LTCH. It is important to note that Kindred-St. Petersburg is located in the far south of heavily populated District 5. The Applications UCH proposes a new freestanding LTCH which will consist of 50 private rooms and which will be located in Connerton, a new town being developed in Pasco County. UCH's proposal will cost approximately $16,982,715. By agreement of the parties, this cost is deemed reasonable. BayCare proposes a "hospital within a hospital" LTCH that will be located within Mease Hospital-Dunedin. The LTCH will be located in an area of the hospital currently used for obstetrics and women's services. The services currently provided in this area will be relocated to Mease Hospital- Countryside. BayCare proposes the establishment of 48 beds in private and semi-private rooms. Review criteria which was stipulated as satisfied by all parties Section 408.035(1)-(9) sets forth the standards for granting certificates of need. The parties stipulated to satisfying the requirements of subsections (3) through (9) as follows. With regard to subsection (3), 'The ability of the applicant to provide quality of care and the applicant's record of providing quality of care,' all parties stipulated that this statutory criterion is not in dispute and that both applicants may be deemed to have satisfied such criteria. With regard to subsection (4), 'The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation,' it was stipulated that both applicants have all resources necessary in terms of both capital and staff to accomplish the proposed projects, and therefore, both applicants satisfy this requirement. With regard to subsection (5), 'The extent to which the proposed services will enhance access to health care for residents of the service district,' it was stipulated that both proposals will increase access. Currently there are geographic, financial and programmatic barriers to access in District 5. The only extant LTCH is located in the southernmost part of District 5. With regard to subsection (6), 'The immediate and long-term financial feasibility of the proposal,' the parties stipulated that UCH satisfied the criterion. With regard to BayCare, it was stipulated that its proposal satisfied the criterion so long as BayCare can achieve its utilization projections and obtain Medicare certification as an LTCH and thus demonstrate short-term and long-term feasibility. This issue will be addressed below. With regard to subsection (7), 'The extent to which the proposal will foster competition that promotes quality and cost- effectiveness,' the parties stipulated that approval of both applications will foster competition that will promote quality and cost effectiveness. The only currently available LTCH in District 5, unlike BayCare and UCH, is a for-profit establishment. With regard to subsection (8), 'The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction,' the parties stipulated that the costs and methods of construction for both proposals are reasonable. With regard to subsection (9), 'the applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent,' it was stipulated that both UCH and BayCare have a demonstrated history and a commitment to providing services to Medicaid, Medicaid HMO, self-pay, and underinsured payments. Technically, of course, BayCare has no history at all. However, its sponsors do, and it is they that will shape the mission for BayCare. BayCare's Medicare certification as an LTCH The evidence of record demonstrates that BayCare can comply with Medicare reimbursement regulations and therefore can achieve its utilization projections and obtain Medicare certification as an LTCH. Thus short-term and long-term feasibility is proven. Because BayCare will be situated as a hospital within a hospital, in Mease Hospital Dunedin, and because there is a relationship between that hospital and BayCare Systems, Medicare reimbursement regulations limit to 25 percent the number of patients that may be acquired from Mease Hospital Dunedin or from an organization that controls directly or indirectly the Mease Hospital Dunedin. Because of this limitation, it is, therefore, theoretically possible that the regulator of Medicare payments, CMS, would not allow payment where more than 25 percent of admissions were from the entire BayCare System. Should that occur it would present a serious but not insurmountable problem to BayCare. BayCare projects that 21 percent of its admissions will come from Mease Hospital Dunedin and the rest will come from other sources. BayCare is structured as an independent entity with an independent board of directors and has its own chief executive officer. The medical director and the medical staff will be employed by the independent board of directors. Upon the greater weight of the evidence, under this structure, BayCare is a separate corporate entity that neither controls, nor is controlled by, BayCare Systems or any of its entities or affiliates. One must bear in mind that because of the shifting paradigms of federal medical regulation, predictability in this regard is less than perfect. However, the evidence indicates that CMS will apply the 25 percent rule only in the case of patients transferring to BayCare from Mease Hospital Dunedin. Most of the Medicare-certified LTCHs in the United States operate as hospitals within hospitals. It is apparent, therefore, that adjusting to the CMS limitations is something that is typically accomplished. BayCare will lease space in Mease Hospital Dunedin which will be vacated by it current program. BayCare will contract with Mease Hospital Dunedin for services such as laboratory analysis and radiology. This arrangement will result in lower costs, both in the short term and in the long term, than would be experienced in a free-standing facility, and contributes to the likelihood that BayCare is feasible in the short term and long term. Criteria related to need The contested subsections of Section 408.035 not heretofore addressed, are (1) and (2). These subsections are illuminated by Florida Administrative Code Rule 59C- 1.008(2)(e)2., which provides standards when, as in this case, there is no fixed-need pool. Florida Administrative Code Rule 59C-1.008(2)(e)2., provides as follows: 2. If no agency policy exists, the applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except where they are inconsistent with the applicable statutory or rule criteria: Population demographics and dynamics; Availability, utilization and quality of like services in the district, sub district or both; Medical treatment trends; and Market conditions. Population Demographics and Dynamics The applicants presented an analysis of the population demographics and dynamics in support of their applications in District 5. The evidence demonstrated that the population of District 5 was 1,335,021 in 2004. It is anticipated that it will grow to 1,406,990 by 2009. The projected growth rate is 5.4 percent. The elderly population in the district, which is defined as persons over the age of 65, is expected to grow from 314,623 in 2004, to 340,676, in 2009, which represents an 8.3 percent increase. BayCare BayCare's service area is defined generally by the geographic locations of Morton Plant Hospital, Morton Plant North Bay Hospital, St. Anthony's Hospital, Mease Hospital Dunedin, and Mease Hospital Countryside. These hospitals are geographically distributed throughout Pinellas County and southwest Pasco County and are expected to provide a base for referrals to BayCare. There is only one extant LTCH in Pinellas County, Kindred, and it is located in the very southernmost part of this densely populated county. Persons who become patients in an LTCH are almost always moved to the LTCH by ambulance, so their movement over a long distance through heavy traffic generates little or no problem for the patient. Accordingly, if patient transportation were the only consideration, movement from the north end of the county to Kindred in the far south, would present no problem. However, family involvement is a substantial factor in an interdisciplinary approach to addressing the needs of LTCH patients. The requirement of frequent movement of family members from northern Pinellas to Kindred through congested traffic will often result in the denial of LTCH services to patients residing in northern Pinellas County or, in the alternative, deny family involvement in the interdisciplinary treatment of LTCH patients. Approximately 70 letters requesting the establishment of an LTCH in northern Pinellas County were provided in BayCare's application. These letters were written by medical personnel, case managers and social workers, business persons, and government officials. The thread common to these letters was, with regard to LTCH services, that the population in northern Pinellas County is underserved. UCH Pasco County has experienced a rapid population growth. It is anticipated that the population will swell to 426,273, in 2009, which represents a 10.1 percent increase over the population in 2004. The elderly population accounts for 28 percent of the population. This is about 50 percent higher than Florida as a whole. Rapid population growth in Pasco County, and expected future growth, has resulted in numerous new housing developments including Developments of Regional Impact (DRI). Among the approved DRI's is the planned community of Connerton, which has been designated a "new town" in Pasco County's Comprehensive Plan. Connerton is a planned community of 8,600 residential units. The plan includes space for a hospital and UCH has negotiated for the purchase of a parcel for that purpose within Connerton. The rate of growth, and the elderly population percentages, will support the proposed UCH LTCH and this is so even if BayCare establishes an LTCH in northern Pinellas County. Availability, utilization, and quality of like services in the district, sub-district, or both The Agency has not established sub-districts for LTCHs. As previously noted, Kindred is the only LTCH extant in District 5. It is a for-profit facility. Kindred was well utilized when it had its pediatric unit and added 22 additional beds. Subsequently, in October 2002, some changes in Medicare reimbursement rules resulted in a reduction of the reimbursement rate. This affected Kindred's income because over 70 percent of its patients are Medicare recipients. Kindred now uses admission criteria that have resulted in a decline in patient admissions. From 1998, the year after Kindred was established, until 2002, annual utilization was in excess of 90 percent. Thereafter, utilization has declined, the 22-bed addition has been shut down, and Kindred projects an occupancy of 55 percent in 2005. Kindred must make a profit. Therefore, it denies access to a significant number of patients in District 5. It denies the admission of patients who have too few "Medicare- reimbursable days" or "Medicaid-reimbursable days" remaining. The record indicates that Kindred only incurs charity care or Medicaid patient days when a patient admitted to Kindred with seemingly adequate funding unexpectedly exhausts his or her funding prior to discharge. Because of the constraints of PPS, Kindred has established admission criteria that excludes certain patients with conditions whose prognosis is so uncertain that it cannot adequately predict how long they will require treatment. Kindred's availability to potential patients is thus constrained. HealthSouth, a licensed CMR, is not a substitute for an LTCH. Although it is clear that there is some overlap between a CMR and an LTCH, HealthSouth, for instance, does not provide inpatient dialysis, will not accept ventilator patients, and does not treat complex wound patients. The nurse staffing level at HealthSouth is inadequate to provide for the type of patient that is eligible for treatment in an LTCH. The fact that LTCHs are reimbursed by Medicare at approximately twice the rate that a CMR is reimbursed, demonstrates the higher acuity level of LTCH services when compared to a CMR. HealthSouth is a facility which consistently operates at high occupancy levels and even if it were capable of providing the services typical of an LTCH, it would not have sufficient capacity to provide for the need. A CMR is a facility to which persons who make progress in an LTCH might repair so that they can return to the activities of daily living. SNFs are not substitutes for LTCHs although there could be some limited overlap. SNFs are generally not appropriate for patients otherwise eligible for the type of care provided by an LTCH. They do not provide the range of services typically provided by an LTCH and do not maintain the registered nurse staffing levels required for delivering the types of services needed for patients appropriate for an LTCH. LTCHs are a stage in the continuum of care. Short- term acute care hospitals take in very sick or injured patients and treat them. Thereafter, the survivors are discharged to home, or to a CMR, or to a SNF, or, if the patients are still acutely ill but stable, and if an LTCH is available, to an LTCH. As noted above, currently in northern Pinellas County and in Pasco County, there is no reasonable access to an LTCH. An intensive care unit (ICU) is, ideally, a treatment phase that is short. If treatment has been provided in an ICU and the patient remains acutely ill but stable, and is required to remain in the ICU because there is no alternative, greater than necessary costs are incurred. Staff in an ICU are not trained or disposed to provide the extensive therapy and nursing required by patients suitable for an LTCH and are not trained to provide support and training to members of the patient's family in preparation for the patient's return home. The majority of patients suitable for an LTCH have some potential for recovery. This potential is not realized in an ICU, which is often counterproductive for patients who are stabilized but who require specialized long-term acute care. Patients who remain in an ICU beyond five to seven days have an increased morbidity/mortality rate. Maintaining patients suitable for an LTCH in an ICU also results in over-utilization of ICU services and can cause congestion when ICU beds are fully occupied. UCH in Pasco County, and to a lesser extent BayCare in northern Pinellas County, will bring to the northern part of District 5 services which heretofore have not been available in the district, or, at least, have not been readily available. Persons in Pasco County and northern Pinellas County, who would benefit from a stay in an LTCH, have often had to settle for some less appropriate care situation. Medical Treatment Trends LTCHs are relatively new cogs in the continuum of care and the evidence indicates that they will play an important role in that continuum in the future. The evidence of record demonstrates that the current trend in medical treatment is to find appropriate post acute placements in an LTCH setting for those patients in need of long-term acute care beyond the stay normally experienced in a short-term acute care hospital. Market conditions The federal government's development of the distinctive PPS for LTCHs has created a market condition which is favorable for the development of LTCH facilities. Although the Agency has not formally adopted by rule a need methodology specifically for LTCHs, by final order it has recently relied upon the "geometric mean length of stay + 7" (GMLOS +7) need methodology. The GMLOS +7 is a statistical calculation used by CMS in administering the PPS reimbursement system in determining an appropriate reimbursement for a particular "diagnostic related group" (DRG). Other need methodologies have been found to be unsatisfactory because they do not accurately reflect the need for LTCH services in areas where LTCH services are not available, or where the market for LTCH services is not competitive. GMLOS +7 is the best analysis the Agency has at this point. Because the population for whom an LTCH might be appropriate is unique, and because it overlaps with other populations, finding an algebraic need expression is difficult. An acuity measure would be the best marker of patient appropriateness, but insufficient data are available to calculate that. BayCare's proposal will provide beneficial competition for LTCH services in District 5 for the first time and will promote geographic, financial, and programmatic access to LTCH services. BayCare, in conducting its need calculations used a data pool from Morton Plant Hospital, Mease Dunedin Hospital, Mease Countryside Hospital, Morton Plant North Bay Hospital, and St. Anthony's Hospital for the 12 months ending September 2003. The hospitals included in the establishment of the pool are hospitals that would be important referral sources for BayCare. BayCare then identified 160 specific DRGs historically served by existing Florida LTCHs, or which could have been served by Florida LTCHs, and lengths of stay greater than the GMLOS for acute care patients, and compared them to the data pool. This resulted in a pool of 871 potential patients. The calculation did not factor in the certain growth in the population of the geographic area, and therefore the growth of potential LTCH patients. BayCare then applied assumptions based on the proximity of the referring hospitals to the proposed LTCH to project how many of the patients eligible for LTCH services would actually be referred and admitted to the proposed LTCH. That exercise resulted in a projected potential volume of 20,265 LTCH patient days originating just from the three District 5 BayCare hospitals and the two Mease hospitals. BayCare assumes, and the assumption is found to be reasonable, that 25 percent of their LTCH volume will originate from facilities other than BayCare or Mease hospitals. Adding this factor resulted in a total of 27,020 patient days for a total net need of 82 beds at 90 percent occupancy. BayCare's GMLOS +7 bed need methodology reasonably projects a bed need of 82 beds based on BayCare's analysis of the demand arising from the three District 5 BayCare hospitals and the two Mease hospitals. UCH provided both a GMLOS +7 and a use rate analysis. The use rate analysis is suspect in a noncompetitive environment and, obviously, in an environment where LTCHs do not exist. UCH's GMLOS +7 analyses resulted in the identification of a need for 159 additional LTCH beds in District 5. This was broken down into a need of 60 beds in Pasco County and 99 additional beds in Pinellas County. There is no not-for-profit LTCH provider in District The addition of BayCare and UCH LTCHs to the district will meet a need in the case of Medicaid, indigent, and underinsured patients. Both BayCare and UCH have agreed in their applications to address the needs of patients who depend on Medicaid, or who are indigent, or who have private insurance that is inadequate to cover the cost of their treatment. The statistical analyses provided by both applicants support the proposed projects of both applicants. Testimony from doctors who treat patients of the type who might benefit from an LTCH testified that those types of facilities would be utilized. Numerous letters from physicians, nurses, and case managers support the need for these facilities. Adverse impacts HealthSouth and Kindred failed to persuade that BayCare's proposal will adversely impact them. HealthSouth provides little of the type of care normally provided at an LTCH. Moreover, HealthSouth is currently operating near capacity. Kindred is geographically remote from BayCare's proposed facility, and, more importantly, remote in terms of travel time, which is a major consideration for the families of patients. Kindred did not demonstrate that it was currently receiving a large number of patients from the geographic vicinity of the proposed BayCare facility, although it did receive some patients from BayCare Systems facilities and would likely lose some admissions if BayCare's application is approved. The evidence did not establish that Kindred would suffer a material adverse impact should BayCare establish an LTCH in Mease Dunedin Hospital. HealthSouth and Kindred conceded that UCH's program would not adversely impact them. The Agency's Position The Agency denied the applications of BayCare and UCH in the SAARs. At the time of the hearing the Agency continued to maintain that granting the proposals was inappropriate. The Agency's basic concern with these proposals, and in fact, the establishments of LTCHs throughout the state, according to the Agency's representative Jeffrey N. Gregg, is the oversupply of beds. The Agency believes it will be a long time before it can see any measure of clinical efficiency and whether the LTCH route is the appropriate way to go. The Agency has approved a number of LTCHs in recent years and is studying them in order to get a better understanding of what the future might hold. The Agency noted that the establishment of an LTCH by ongoing providers, BayCare Systems and UCH, where there are extant built-in referring facilities, were more likely to be successful than an out-of-state provider having no prior relationships with short-term acute care hospitals in the geographic vicinity of the LTCH. The Agency noted that both a referring hospital and an LTCH could benefit financially by decompressing its intensive care unit, and thus maximizing their efficiency. The Agency did not explain how, if these LTCHs are established, a subsequent failure would negatively affect the delivery of health services in District 5. The Agency, when it issued its SAAR, did not have the additional information which became available during the hearing process.
Recommendation Based upon the Findings of Fact and Conclusions of Law, it is RECOMMENDED that UCH Certificate of Need Application No. 9754 and BayCare Certificate of Need Application No. 9753 satisfy the applicable criteria and both applications should be approved. DONE AND ENTERED this 29th day of November, 2005, in Tallahassee, Leon County, Florida. S HARRY L. HOOPER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of November, 2005. COPIES FURNISHED: Robert A. Weiss, Esquire Parker, Hudson, Rainer & Dobbs, LLP The Perkins House, Suite 200 118 North Gadsden Street Tallahassee, Florida 32301 J. Robert Griffin, Esquire J. Robert Griffin, P.A. 1342 Timberlane Road, Suite 102-A Tallahassee, Florida 32312-1762 Patricia A. Renovitch, Esquire Oertel, Hoffman, Fernandez, Cole, & Bryant P.A. Post Office Box 1110 Tallahassee, Florida 32302-1110 Geoffrey D. Smith, Esquire Blank, Meenan & Smith, P.A. 204 South Monroe Street Tallahassee, Florida 32301 Timothy Elliott, Esquire Agency for Health Care Administration 2727 Mahan Drive Building Three, Mail Station 3 Tallahassee, Florida 32308 Alan Levine, Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Christa Calamas, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Richard Shoop, Agency Clerk Agency for Health Care Administration Fort Knox Building, Mail Station 3 2727 Mahan Drive Tallahassee, Florida 32308
Findings Of Fact Respondent operates Lake Wales Convalescent Center (the Center) in Lake Wales, Florida. The administrator of the Center and her husband are long time residents of Lake Wales, who have known many of the nursing home residents over a period of years. The Center enjoys a reputation for excellent nursing home care, and charges less for its services than most other nursing homes. In the past fourteen years, petitioner has received not one complaint about the care of any patient at the Center. The Center provides residential care and nursing services for privately paying and indigent persons alike. At all pertinent times, the Center provided services to indigent persons under a series of annual agreements between the Center and petitioner. See respondent's exhibit No. 2. In 1972, a "service worker" in petitioner's employ told the Center's administrator, Winifred J. Coleman, that one Lizzie Wilson was eligible for care at the Center at petitioner's expense, in accordance with the agreement then in force between the parties. With this understanding, Ms. Wilson was admitted to the Center. Eventually, however, another employee of petitioner, a "payments worker," determined that Ms. Wilson was ineligible for care at petitioner's expense. The latter determination held sway within petitioner agency. By the time petitioner notified respondent of Ms. Wilson's ineligibility, Ms. Wilson had stayed at the Center some four months. A few days after respondent was notified, Ms. Wilson left the Center. If petitioner had reimbursed respondent for the expenses incurred in the care of Ms. Wilson up to the time petitioner notified respondent that she was ineligible, petitioner would have paid respondent $1,750.00. If respondent had been reimbursed for the services rendered during the additional time it took to find another place for Ms. Wilson, respondent would have received another $268.00. All told, respondent furnished care to Ms. Wilson for 144 days, and missed reimbursal in the amount of $2,018.00. During the year 1972, respondent's occupancy rate was 99.67 percent. In calculating the basis for reimbursal under its contract with petitioner for services rendered in 1972, the Center included the $2,018.00 in the $3,162.00 bad debt item which it reported in its unaudited statement of cost operations. Respondent's exhibit No. 1. No later than December 16, 1975, petitioner furnished respondent a copy of an audit report dated September 30, 1975, disallowing the bad debt item in its entirety. Respondent's exhibit No. 2. During the year 1976, respondent paid interest at the rate of 6 percent to its shareholders on a loan the shareholders had made to respondent. Interest for 1976 amounted to $3,189.00. Respondent claimed the interest as an expense in calculating its costs for reimbursal purposes. On March 10, 1978, petitioner completed its audit of the figures for the year 1976. Petitioner treated the loan made to respondent by its shareholders as if it were equity invested in respondent. Petitioner allows a rate of return on equity in excess of 10 percent. Although Petitioner disallowed the interest as an expense, Petitioner's treatment of the loan as equity resulted in a net benefit to respondent.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner withhold all or part of regular payments to respondent until it has recovered nine thousand one hundred sixty-two dollars ($9,162.00) from respondent. DONE and ENTERED this 7th day of February, 1980, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Anthony N. DeLuccia, Jr., Esquire Post Office Box 06085 Ft. Myers, Florida 33906 Clay A. Terry, Esquire Post Office Box 1260 Lake Wales, Florida 33863
The Issue Whether, based upon a preponderance of the evidence, the Agency for Health Care Administration (AHCA) lawfully assigned conditional licensure status to Harbour Health Center for the period June 17, 2004, to June 29, 2004; whether, based upon clear and convincing evidence, Harbour Health Center violated 42 Code of Federal Regulations (C.F.R.) Section 483.25, as alleged by AHCA; and, if so, the amount of any fine based upon the determination of the scope and severity of the violation, as required by Subsection 400.23(8), Florida Statutes (2004).
Findings Of Fact Based upon stipulations, deposition, oral and documentary evidence presented at the final hearing, and the entire record of the proceeding, the following relevant findings of fact are made: At all times material hereto, AHCA was the state agency charged with licensing of nursing homes in Florida under Subsection 400.021(2), Florida Statutes (2004), and the assignment of a licensure status pursuant to Subsection 400.23(7), Florida Statutes (2004). AHCA is charged with the responsibility of evaluating nursing home facilities to determine their degree of compliance with established rules as a basis for making the required licensure assignment. Additionally, AHCA is responsible for conducting federally mandated surveys of those long-term care facilities receiving Medicare and Medicaid funds for compliance with federal statutory and rule requirements. These federal requirements are made applicable to Florida nursing home facilities pursuant to Florida Administrative Code Rule 59A-4.1288, which states that "[n]ursing homes that participate in Title XVIII or XIX must follow certification rules and regulations found in 42 C.F.R. §483, Requirements for Long Term Care Facilities, September 26, 1991, which is incorporated by reference." The facility is a licensed nursing facility located in Port Charlotte, Charlotte County, Florida. Pursuant to Subsection 400.23(8), Florida Statutes (2004), AHCA must classify deficiencies according to the nature and scope of the deficiency when the criteria established under Subsection 400.23(2), Florida Statutes (2004), are not met. The classification of any deficiencies discovered is, also, determinative of whether the licensure status of a nursing home is "standard" or "conditional" and the amount of administrative fine that may be imposed, if any. Surveyors note their findings on a standard prescribed Center for Medicare and Medicaid Services (CMS) Form 2567, titled "Statement Deficiencies and Plan of Correction" and which is commonly referred to as a "2567" form. During the survey of a facility, if violations of regulations are found, the violations are noted and referred to as "Tags." A "Tag" identifies the applicable regulatory standard that the surveyors believe has been violated, provides a summary of the violation, sets forth specific factual allegations that they believe support the violation, and indicates the federal scope and severity of the noncompliance. To assist in identifying and interpreting deficient practices, surveyors use Guides for Information Analysis Deficiency Determination/Categorization Maps and Matrices. On, or about, June 14 through 17, 2004, AHCA conducted an annual recertification survey of the facility. As to federal compliance requirements, AHCA alleged, as a result of this survey, that the facility was not in compliance with 42 C.F.R. Section 483.25 (Tag F309) for failing to provide necessary care and services for three of 21 sampled residents to attain or maintain their respective highest practicable physical, mental, and psychosocial well-being. As to the state requirements of Subsections 400.23(7) and (8), Florida Statutes (2004), and by operation of Florida Administrative Code Rule 59A-4.1288, AHCA determined that the facility had failed to comply with state requirements and, under the Florida classification system, classified the Federal Tag F309 non-compliance as a state Class II deficiency. Should the facility be found to have committed any of the alleged deficient practices, the period of the conditional licensure status would extend from June 17, 2004, to June 29, 2004. Resident 8 Resident 8's attending physician ordered a protective device to protect the uninjured left ankle and lower leg from injury caused by abrasive contact with the casted right ankle and leg. Resident 8 repeatedly kicked off the protective device, leaving her uninjured ankle and leg exposed. A 2.5 cm abrasion was noted on the unprotected ankle. The surveyors noted finding the protective device in Resident 8's bed but removed from her ankle and leg. Resident 8 was an active patient and had unsupervised visits with her husband who resided in the same facility but who did not suffer from dementia. No direct evidence was received on the cause of the abrasion noted on Resident 8's ankle. Given Resident 8's demonstrated propensity to kick off the protective device, the facility should have utilized a method of affixing the protective device, which would have defeated Resident 8's inclination to remove it. The facility's failure to ensure that Resident 8 could not remove a protective device hardly rises to the level of a failure to maintain a standard of care which compromises the resident's ability to maintain or reach her highest practicable physical, mental or psychosocial well-being. The failure to ensure that the protective device could not be removed would result in no more than minimal discomfort. Resident 10 Resident 10 has terminal diagnoses which include end- stage coronary artery disease and progressive dementia and receives hospice services from a local Hospice and its staff. In the Hospice nurse's notes for Resident 10, on her weekly visit, on May 17, 2004, was the observation that the right eye has drainage consistent with a cold. On May 26, 2004, the same Hospice nurse saw Resident 10 and noted that the cold was gone. No eye drainage was noted. No eye drainage was noted between that date and June 2, 2004. On June 3, 2004, eye drainage was noted and, on June 4, 2004, a culture of the drainage was ordered. On June 7, 2004, the lab report was received and showed that Resident 10 had a bacterial eye infection with Methicillin Resistant Staphylococcus Aureus (MRSA) bacteria. On June 8, 2004, the attending physician, Dr. Brinson, referred the matter to a physician specializing in infectious disease, and Resident 10 was placed in contact isolation. The infectious disease specialist to whom Resident 10 was initially referred was not available, and, as a result, no treatment was undertaken until a second specialist prescribed Bactrim on June 14, 2004. From June 8, 2004, until June 14, 2004, Resident 10 did not demonstrate any outward manifestations of the diagnosed eye infection. A June 9, 2004, quarterly pain assessment failed to note any discomfort, eye drainage or discoloration. In addition to noting that neither infectious control specialist had seen Resident 10, the nurses notes for this period note an absence of symptoms of eye infection. Colonized MRSA is not uncommon in nursing homes. A significant percentage of nursing home employees test positive for MRSA. The lab results for Resident 10 noted "NO WBC'S SEEN," indicating that the infection was colonized or inactive. By placing Resident 10 in contact isolation on June 8, 2004, risk of the spread of the infection was reduced, in fact, no other reports of eye infection were noted during the relevant period. According to Dr. Brinson, Resident 10's attending physician, not treating Resident 10 for MRSA would have been appropriate. The infectious disease specialist, however, treated her with a bacterial static antibiotic. That is, an antibiotic which inhibits further growth, not a bactericide, which actively destroys bacteria. Had this been an active infectious process, a more aggressive treatment regimen would have been appropriate. Ann Sarantos, who testified as an expert witness in nursing, opined that there was a lack of communication and treatment coordination between the facility and Hospice and that the delay in treatment of Resident 10's MRSA presented an unacceptable risk to Resident 10 and the entire resident population. Hospice's Lynn Ann Lima, a registered nurse, testified with specificity as to the level of communication and treatment coordination between the facility and Hospice. She indicated a high level of communication and treatment coordination. Dr. Brinson, who, in addition to being Resident 10's attending physician, was the facility's medical director, opined that Resident 10 was treated appropriately. He pointed out that Resident 10 was a terminally-ill patient, not in acute pain or distress, and that no harm was done to her. The testimony of Hospice Nurse Lima and Dr. Brinson is more credible. Resident 16 Resident 16 was readmitted from the hospital to the facility on May 24, 2004, with a terminal diagnosis of chronic obstructive pulmonary disease and was receiving Hospice care. Roxanol, a morphine pain medication, had been prescribed for Resident 16 for pain on a pro re nata (p.r.n.), or as necessary, basis, based on the judgment of the registered nurse or attending physician. Roxanol was given to Resident 16 in May and on June 1 and 2, 2004. The observations of the surveyor took place on June 17, 2004. On June 17, 2004, at 9:30 a.m., Resident 16 underwent wound care treatment which required the removal of her sweater, transfer from sitting upright in a chair to the bed, and being placed on the left side for treatment. During the transfer and sweater removal, Resident 16 made noises which were variously described as "oohs and aahs" or "ows," depending on the particular witness. The noises were described as typical noises for Resident 16 or evidences of pain, depending on the observer. Nursing staff familiar with Resident 16 described that she would demonstrate pain by fidgeting with a blanket or stuffed animal, or that a tear would come to her eye, and that she would not necessarily have cried out. According to facility employees, Resident 16 did not demonstrate any of her typical behaviors indicating pain on this occasion, and she had never required pain medication for the wound cleansing procedure before. An order for pain medication available "p.r.n.," requires a formalized pain assessment by a registered nurse prior to administration. While pain assessments had been done on previous occasions, no formal pain assessment was done during the wound cleansing procedure. A pain assessment was to be performed in the late afternoon of the same day; however, Resident 16 was sleeping comfortably. The testimony on whether or not inquiry was made during the wound cleansing treatment as to whether Resident 16 was "in pain," "okay," or "comfortable," differs. Resident 16 did not receive any pain medication of any sort during the period of time she was observed by the surveyor. AHCA determined that Resident 16 had not received the requisite pain management, and, as a result, Resident 16’s pain went untreated, resulting in harm characterized as a State Class II deficiency. AHCA's determination is not supported by a preponderance of the evidence. In the context that the surveyor considered what she interpreted as Resident 16's apparent pain, deference should have been given to the caregivers who regularly administered to Resident 16 and were familiar with her observable indications of pain. Their interpretation of Resident 16's conduct and their explanation for not undertaking a formal pain assessment are logical and are credible.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding: The facility's failure to secure the protective device to Resident 8's lower leg is not a Class II deficiency, but a Class III deficiency. The facility's care and treatment of Residents 10 and 16 did not fall below the requisite standard. The imposition of a conditional license for the period of June 17 to June 29, 2004, is unwarranted. The facility should have its standard licensure status restored for this period. No administrative fine should be levied. DONE AND ENTERED this 3rd day of June, 2005, in Tallahassee, Leon County, Florida. S JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of June, 2005. COPIES FURNISHED: Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Eric Bredemeyer, Esquire Agency for Health Care Administration 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308
The Issue Did Golden Shores fail to provide adequate and appropriate nursing care for Mrs. Lindablad because maggots were found in a wound on her right hip and in the wall of her vagina between October 22, 1979 and October 24, 1979? Did Golden Shores violate the terms of either Chapter 400, Part I, Florida Statutes, or Section 10D-29, Florida Administrative Code, by refusing to allow inspection of its facility by an OLC inspection team on January 25, 1980?
Findings Of Fact The Golden Shores Convalescent Center, Inc. is a nursing home facility in Tampa, Florida. Ms. Patricia Gilbert is its Administrator. The Office of Licensure and Certification (OLC) of HRS is responsible for the investigation of complaints about the operation of nursing facilities, such as Golden Shores, which are licensed by HRS. Prior to the OLC investigation in issue the Office had received an anonymous complaint about housekeeping, urine odors, dietary preparation, and staffing at Golden Shores. The Office had also received a complaint from the Chairman of the Ombudsman Committee alleging that portions of the nurses call system were not functioning. As the result of these complaints, Mr. Joel Montgomery, an HRS hospital consultant, Mrs. Dorothy Brown, a public health nurse, and Mrs. Emily Echols, a nutrition consultant, arrived unannounced at Golden Shores on January 25, 1980, at 9:00 A.M. to conduct a complaint survey of the facility. Two days prior to this visit the Tampa Tribune newspaper published a story, described by its author as "sensational", on the occurrence of maggots in a Golden Shores patient. The Golden Shores staff was very agitated about the bad publicity in the article. They felt betrayed by HRS whom they assumed to be the source of the story.3/ It was under these circumstances that the Administrator of Golden Shores, Mrs. Gilbert, refused to allow the inspection team to tour the facility. When the OLC team arrived, Mrs. Gilbert placed a call to the facility's counsel and then informed her staff that the team was there for an inspection but she was seeking legal advice. After her conference with counsel she decided to refuse the team access that morning. She did not want to allow an inspection of the facility without counsel present. She was especially concerned that her staff would comment on the maggot case which she intended to later litigate with HRS.4/ While Mrs. Gilbert courteously offered to allow an inspection of the facility in the afternoon of January 25, 1980, that opportunity conflicted with the schedule of Mr. Montgomery, the inspection team leader. A later inspection was subsequently arranged between the parties. It was satisfactorily conducted on January 31, 1980. In the interim between January 25, 1980 and January 30, 1980, HRS placed a moratorium on new admissions into Golden Shores. This was lifted when Golden Shores agreed to a second inspection. During this inspection it was discovered that except for the nurses call system problem the complaints were unfounded. While the allegations of the anonymous complaint proved to be untrue, the facts alleged in the complaint were directly related to the proper care and health of Golden Shores' patients. On August 28, 1979, Mrs. Alice Lindablad was admitted to Golden Shores from Lykes Memorial Hospital in Brooksville, Florida for long term care. Mrs. Lindablad was in poor physical condition. She had been diagnosed as having arteriosclerotic heart disease, congestive heart failure, and multiple infected decubiti ulcers (bed sores). The ulcers which were present on the patient's legs, feet and hips contained necrotic (dead) tissues and oozed a green fluid. The skin around the ulcers was black. The patient also had a vascular insufficiency which caused her left foot to develop gangrene. The foot became necrotic, foul smelling, and turned black. Dr. Perez was Mrs. Lindablad's attending physician. Because of the condition of her left foot, he transferred the patient on October 5, 1979, to St. Joseph's Hospital for a surgical evaluation. She was determined to be a poor surgery risk and therefore nothing was done toward amputating her left foot. She was returned to Golden Shores and remained there until her death on October 31, 1979. During her care at Golden Shores, Dr. Perez prescribed the following treatment for the decubitus ulcers: wet to dry dressings over the ulcers, q-4 hours 5/; mechanical debridement of the wounds; and the administration of antibiotics. After her return to Golden Shores, Mrs. Lindablad slowly deteriorated. The ulcers remained infected. She became lethargic and exhibited the symptoms of possible septicemia (a local infection spreading throughout the blood stream). The most serious ulcer which was on her right hip was so deep that the bone could be seen. By October 19, 1979, her left foot was completely black. During the 3:00 to 11:00 P.M. nursing shift on October 22, 1979, a nurses aide, Ms. Lorine Rowland and Ms. Dorothy Poore, the evening charge nurse, entered Mrs. Lindablad's room to change her dressings. Because more 4x4 dressings were needed, Ms. Poore left to obtain them. At the same time, as Ms. Rowland removed the dressing on the patient's right hip, she saw maggots in the sore. Ms. Rowland put the bandage back on and told what she saw to Ms. Poore who immediately called Dr. Perez. He responded to the message left with his answering service within five to seven minutes. After Ms. Poore told him what she had seen, he said "good, we'll just cover that with a dry dressing and make sure it is well taped down". The maggots continued to be present in the patient's right hip ulcer until around 9:00 A.M. on October 24, 1979. At that time Ms. Brunjes, director of nursing services, examined the patient and found no evidence of maggots either on the patient's body or in her bed linen. Prior to Ms. Brunjes' examination maggots had been noted by Ms. Suzanne Davis, LPN, on the October 23, 1979, 11:00 P.M. to October 24, 1979, 7:00 A.M. shift in Ms. Lindablad's labia and her vagina. The maggots' presence on Ms. Lindablad was a fortuitous occurrence. They were not purposely applied by either the nurses or by Dr. Perez. But once there, Dr. Perez decided to take advantage of their ability to debride necrotic tissue without damaging live tissue. Maggots are the larva of the common house fly. The presence of maggots indicates that at sometime while she was at Golden Shores a female fly must have landed on Mrs. Lindablad and laid eggs in her right hip ulcer. Flies are attracted to necrotic tissue as a place for them to lay eggs. Because of her numerous sores and rotting left gangrenous leg, Mrs. Lindablad was very attractive to flies. Before the advent of modern antibiotics sterile maggots were used by the medical profession to debride wounds of dead tissue. While this practice is no longer common today, the medical community is still familiar with the use of maggots and their use is not necessarily poor health care. There was a calculated risk in allowing the maggots to remain in the patient here because they had not been raised in a sterile environment and they could spread unknown bacteria. It is not below community medical standards for Dr. Perez to have allowed the continued presence of maggots in Mrs. Lindablad's right hip ulcer and it is not poor health care for Golden Shores to have followed his orders to leave the maggots undisturbed. There is no evidence that near the time of the occurrence of maggots on Mrs. Lindablad Golden Shores had a prevalence of flies in the patient care area, or in any other part of the facility. An occasional fly has however been observed in the wards. No flies were ever observed in Mrs. Lindablad's room. The record here is barren of any showing that Golden Shores either took extraordinary measures to prevent the occurrence of flies or that Golden Shores was careless about insect control. Subsequent to the appearance of the maggots in Mrs. Lindablad's hip decubitus, they were noted around her vagina and in her bed linen. Maggots are attracted to the warm damp mucoid areas of the human body. Dr. Perez on being notified of the maggots initial appearance had ordered a dry dressing over the maggots to be well taped down. It is a reasonable inference that this taping was to prevent the possible migration of the maggots. Again there is no showing that the staff at Golden Shores were either extraordinarily careful about taking measures to prevent the migration of the maggots on Mrs. Lindablad or that they were careless in not preventing the maggots migration. Once the maggots were discovered on the edge of the patient's labia and her vagina, they were washed away by Ms. Davis with a sterile solution and disposed of. The linen on the patient's bed was immediately changed. It is possible that the tape which held the dry dressing on Mrs. Lindablad's right hip became loose from the many times her body had to be turned. A paper tape, rather than ordinary adhesive tape, was used to secure the patient's dressings because her delicate skin could have been harmed by ordinary tape. Mrs. Lindablad's death on October 31, 1979, was not in any way related to the occurance of maggots on her body or in her bed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law it is, RECOMMENDED: That an administrative fine in the amount of $300.00 be imposed on Golden Shores Convalescent Center in Case No. 80-341. It is further RECOMMENDED that the complaint in Case No. 80-342 be dismissed. DONE and RECOMMENDED this 10th day of April, 1981, in Tallahassee, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of April, 1981.
