The Issue Whether the Certificate of Need (CON) applications filed by Odyssey Healthcare of Collier County, Inc., d/b/a Odyssey Healthcare of Northwest Florida, Inc. (Odyssey), and HPH South, Inc. (HPH), for a new hospice program in the Agency for Health Care Administration (AHCA or the Agency) Service Area 5B, satisfy, on balance, the applicable statutory and rule review criteria to warrant approval; and whether such applications establish a need for a new hospice based on special circumstances, and, if so, which of the two applications best meets the applicable criteria for approval. Holding: Neither applicant proved the existence of special circumstances warranting approval of an additional hospice program in Service Area 5B. Although neither application is recommended for approval in this Recommended Order, both applicants, on balance, satisfy the applicable statutory and rule criteria. Of the two, HPH best satisfies the criteria.
Findings Of Fact The Parties AHCA The Agency for Health Care Administration is the state agency authorized to evaluate and render final determinations on CON applications pursuant to Subsection 408.034(1), Florida Statutes. HPH HPH is a newly created not-for-profit corporation formed to initiate hospice services in Pinellas County. HPH is a wholly-owned subsidiary of Hernando-Pasco Hospice, Inc., d/b/a HPH Hospice and is one of the oldest, not-for-profit community hospices in Florida. HPH Hospice was incorporated in 1982 to serve terminally ill persons within Hernando and Pasco Counties. HPH was approved to expand its services north to Citrus County in 2004. HPH is a high-quality provider of hospice services in the service areas where it currently operates. It provides pain control and symptom management, spiritual care, bereavement, volunteer, social work, and other programs. HPH employs a physician-driven model of hospice care, with significant involvement of hospice and palliative care physicians who are physically present treating patients in their homes. The number of physician home visits provided to hospice patients by HPH physicians is larger than many hospices in Florida and throughout the United States. In 2009, HPH provided over 35,000 visits by physicians, advanced registered nurse practitioners, and licensed physician assistants to its hospice patients. The majority of these visits occurred in the patients' homes. HPH operates multiple facilities that allow for provision of services to patients in various settings and hospice levels of care. Among its facilities, HPH operates four buildings it calls Care Centers, at which patients can receive general in-patient care. Additionally, HPH operates four units which it calls Hospice Houses. Those units provide for residential care in a home-like environment for patients who do not have caregivers at home or who otherwise are in need of a home. HPH receives no reimbursement for room and board for the care provided at its Hospice Houses and expends over $1.4 million annually in charity care to operate these Hospice Houses for the benefit of its patients. HPH has an established record of providing all levels of hospice care and does not use its Care Centers as a substitute for providing continuous care in the patient's home when such care is needed. Annually, HPH provides approximately percent of its patient days for continuous care patients. HPH has well-developed staff education and training programs, including specialized protocols for care and treatment of patients by terminal disease type such as Alzheimer's, COPD, cancer, failure to thrive, and pulmonary diseases. Odyssey Odyssey is the entity applying for a new hospice program in Service Area 5B. The sole shareholder of Odyssey is Odyssey HealthCare Operating B, LP, which is a wholly-owned subsidiary of Odyssey HealthCare, Inc. (OHC), Odyssey's parent and management affiliate. Odyssey was formed for the purpose of filing for CON applications in Florida and, thereafter, for owning and operating hospice programs in Florida. OHC is a publicly-traded company founded in 1996 and focuses on caring for patients at the end of life's journey. OHC's sole line of business is hospice services. OHC's patient population consists of approximately 70 percent non-cancer and 30 percent cancer patients. OHC is one of the largest providers of hospice care in the United States. OHC has approximately 92 Medicare-certified programs in 29 states, including established programs in Miami-Dade (Service Area 11) and Volusia (Service Area 4B) Counties and a start-up program in Marion County (Service Area 3B), which was licensed in January 2010. Over four years ago, OHC was the subject of an investigation by the United States Department of Justice that ultimately resulted in a settlement and payment of $13 million to the federal government in July 2006. The settlement did not involve the admission of liability or acknowledgement of any wrongdoing by OHC. As part of the settlement, OHC entered into a corporate integrity agreement (CIA) with a term of five years. Odyssey is now in the final year of the CIA. The settlement and CIA allow OHC to self-audit to ensure compliance with the Medicare conditions of participation, which is the first and only time the OIG has allowed a provider to self audit. Suncoast Suncoast is a large and well-developed comprehensive hospice program serving Pinellas County, Service Area 5B. Suncoast is the sole provider of hospice services in Service Area 5B. According to data reported to the Department of Elder Affairs, Suncoast had 7,375 admissions and provided 795,102 patient days of care in 2009, more than any other Florida hospice. In that same year, Suncoast provided 115,247 patient days of care in assisted living facilities, the third highest total in Florida. Suncoast considers itself a model for hospice across the United States and the world. Suncoast has a large depth and breadth of programs, including community programs offered by its affiliate organizations, such as the AIDS Service Association of Pinellas County, the Suncoast Institute, and Project Grace. Suncoast is active in the national organization for hospices and interacts with programs that use it as a model and resource. Unlike the applicants, Suncoast does not use the Medicare conditions or definitions to limit or define the scope of services it provides. Under the Florida definition, hospice is provided to patients with a life expectancy of 12 months or less. HPH, by way of contrast, uses the Centers for Medicare and Medicaid Services definition for hospice, i.e., a prognosis of six months or less. Overview of Hospice Services In Florida, hospice programs are required to provide a continuum of palliative and supportive care for terminally ill patients and their families. Under Florida law, a terminally ill patient has a prognosis that his/her life expectancy is one year or less if the illness runs its normal course. Under Medicare, a terminally ill patient is eligible for the Medicare Hospice benefits if their life expectancy is six months or less. Hospice services must be available 24 hours a day, seven days a week, and must include certain core services, including nursing, social work, pastoral care or counseling, dietary counseling, and bereavement counseling. Physician services may be provided by the hospice directly or through contract. Hospices are required to provide four levels of hospice care: routine, continuous, in-patient, and respite. Hospice services are furnished to a patient and family either directly by a hospice or by others under contractual arrangements with a hospice. Services may be provided in a patient's temporary or permanent residence. If the patient needs short-term institutionalization, the services are furnished in cooperation with those contracted institutions or in a hospice in-patient facility. Routine home care comprises the vast majority of hospice patient days. Florida law states that hospice care and services provided in a private home shall be the primary form of care. Hospice care and services, to the extent practicable and compatible with the needs and preferences of the patient, may be provided by the hospice care team to a patient living in an assisted living facility (ALF), adult family-care home, nursing home, hospice residential unit or facility, or other non-domestic place of permanent or temporary residence. A resident or patient living in an ALF, nursing home, or other facility, who has been admitted to a hospice program, is considered a hospice patient, and the hospice program is responsible for coordinating and ensuring the delivery of hospice care and services to such person pursuant to the statutory and rule requirements. The in-patient level of care provides an intensive level of care within a hospital setting, a skilled nursing unit or in a freestanding hospice in-patient facility. The in- patient component of care is a short-term adjunct to hospice home care and home residential care and should only be used for pain control, symptom management, or respite care in a limited manner. In Florida, the total number of in-patient days for all hospice patients in any 12-month period may not exceed 20 percent of the total number of hospice days for all the hospice patients of the licensed hospice. Continuous care, similar to in-patient care, is basically emergency room or crisis care that can be provided in a home care setting or in any setting where the patient resides. Continuous care, like in-patient care, was designed to be provided for short amounts of time, usually when symptoms become severe and skilled and individual interventions are needed for pain and symptom management. Respite care is generally designed for caregiver relief. It allows patients to stay in hospice facilities for brief periods to provide breaks for the caregivers. Respite care is typically a very minor percentage of overall patient days and is generally designed for caregiver relief. Medicare reimburses the different levels of care at different rates. The highest level of reimbursement is for continuous care. Approximately 85 to 90 percent of hospice care is covered by Medicare. The goal of hospice is to provide physical, emotional, psychological, and spiritual comfort and support to a terminally ill patient and their family. Hospice care provides palliative care as opposed to curative care, with the focus of treatment centering on palliative care and comfort measures. There is no "bright line test" as to what constitutes palliative care and what constitutes curative care. The determination is made on a case-by-case basis depending upon the facts and circumstances of each such case. However, palliative care generally refers to services or interventions which are not curative, but are provided for the reduction or abatement of pain and suffering. Hospice care is provided pursuant to a plan of care that is developed by an interdisciplinary group consisting of physicians, nurses, social workers, and various counselors, including chaplains. There are certain services required by individual hospice patients that are not necessarily covered by Medicare and/or private or commercial insurance. These services may include music therapy, pet therapy, art therapy, massage therapy, and aromatherapy. There are also more complicated and expensive non-covered services, such as palliative chemotherapy and radiation that may be indicated for severe pain control and symptom control. Suncoast provides, and both Odyssey and HPH propose, to provide hospice patients with all of the core services and many of the other services mentioned above. Fixed Need Pool The Agency has a numeric need formula within its rule for determining the need for an additional hospice program in a service area. See Fla. Admin. Code R. 59C-1.0355(4)(a). When applying the formula in the present case, AHCA ultimately determined that the fixed need was zero for the second batching cycle of 2009. In the absence of numeric need, an applicant must document the existence of one of three delineated special circumstances set forth in Florida Administrative Code Rule 59C-1.0355(4)(d), i.e., (1) That a specific terminally ill population is not being served; (2) That a county or counties within the service area of a licensed hospice program are not being served; or (3) That there are persons referred to hospice programs who are not being admitted within 48 hours. Absent numeric need or one of the delineated special circumstances, there cannot be approval of a new hospice program. In forecasting need under the hospice rule's methodology, AHCA uses an average three-year historical death rate. It applies this average against the forecasted population for a two-year planning horizon. AHCA also uses a statewide penetration rate, which is the number of hospice admissions divided by hospice deaths. The statewide average penetration rate is subdivided into four categories: cancer over age 65, cancer under age 65, non-cancer over age 65, and non-cancer under age 65. The projected hospice admissions (based on death rate and projected population growth) in each category are then compared to the most recent published actual admissions to determine the number of projected un-met admissions in each category. If the total un-met admissions in all categories exceed 350, a new hospice is warranted, unless there is a recently approved hospice in the service area or a new hospice provider has not been operational for two years. In the instant case, AHCA's final projections showed the net un-met need for hospice's admissions in Service Area 5B was 318, i.e., below the threshold amount of 350 necessary to establish need for an additional hospice program. The fixed need pool for the purpose of this administrative hearing is zero. HPH is primarily basing its determination of need for a new hospice on its contention that there are three specific terminally ill population groups in Pinellas County that are not being served. Odyssey is primarily basing its determination of need for a new hospice on its contention that there are persons being referred to the existing hospice program in Pinellas County who are not being admitted within 48 hours. The Proposals HPH's Proposal HPH proposes to establish its new hospice program in Pinellas County, Service Area 5B. HPH is currently licensed to provide hospice care in three contiguous sub-districts north of Service Area 5B, i.e., in Hernando, Pasco, and Citrus counties. HPH's corporate headquarters is located in Pasco County, ten to 15 minutes from the Pinellas County border. HPH currently operates a home health agency in Pinellas County. HPH's CON application identifies special circumstances justifying approval of its proposal, including four sub-populations of terminally ill persons who are currently underserved in Service Area 5B: (1) patients living in ALFs; (2) patients requiring continuous care; (3) medically complex patients; and (4) patients not being admitted within 48-hours. Another circumstance identified by HPH to support approval of its application is the fact that Pinellas County is one of the most populous and most elderly service areas in the State, and yet, it only has a single hospice provider. HPH argues that the fact Suncoast is a sole hospice provider for the service area exacerbates and contributes to the problems of gaps in available hospice services to the specific terminally ill sub-populations identified in its CON application. HPH proposes a de-centralized model of hospice service delivery similar to its model in the three contiguous counties where HPH presently provides hospice services. HPH proposes contracting with existing nursing homes and hospitals for in-patient beds ("scatter beds") throughout Service Area 5B. HPH then projects that it could offer in-patient services in the local neighborhoods of patients and families where they live, as opposed to transferring patients to a single in-patient facility for the provider's convenience. As census increases, HPH commits to establish, by month seven of operation, a dedicated in-patient unit to provide in-patient level of care and Hospice House residential care to patients in a home-like environment. Like its hospice operations in Hernando, Pasco and Citrus Counties, HPH proposes to implement its "physician- driven" model of hospice care in Service Area 5B, allowing for greater involvement of physicians in the care and treatment of hospice patients, including physician home visits. Odyssey's Proposal Odyssey proposes to address lack of competition2 in Service Area 5B and the special circumstance of patients not being admitted within 48 hours of referral. Under AHCA's hospice rule, an applicant may demonstrate the need for a new hospice provider if there are persons referred to a hospice program who are not being admitted within 48 hours. However, the applicant must indicate the number of such persons. Odyssey relies upon referral of admission statistical information previously provided by Suncoast to a sister Odyssey entity in a 2005 hospice CON matter. Suncoast at that time provided three years of data that demonstrated between 1,700 (31 percent of admissions) and 2,300 (38 percent of admissions) of patients admitted to Suncoast were admitted 72 hours or more after referral. The definition of referral by Suncoast, however, differs from the definition of referral relied upon by Odyssey. (See Paragraph 56, herein.) Odyssey also provided letters of support from the community to further evidence the existence of the 48-hour special circumstance. However, the letters of support originally appeared in an application filed by Odyssey in 2007 and were not given any weight in the instant proceeding based on their staleness. Odyssey also contends that the existence of a sole provider in Service Area 5B has created a monopolistic situation in the service area. It further contends that the lack of competition has led to the existence of a 48-hour special circumstance in Service Area 5B. Approval of Odyssey's application will, it says, eliminate the monopoly currently existing in Service Area 5B and will address the lack of competition currently occurring in Service Area 5B. Subsection 408.045(2), Florida Statutes, speaks of a "regional monopoly," but there is no credible evidence in the record to suggest that Suncoast's position as a sole provider in Pinellas County constitutes a "regional monopoly." Facts Concerning Special Circumstances Arguments Service Area Demographics Hospice Service Area 5B, Pinellas County, is a single-county hospice service area with a population of approximately one million residents. Pinellas County is currently ranked as the fourth largest county in the State in total numbers of elderly persons over 65 years of age, as well as elderly persons over 75 years of age, behind only Miami-Dade, Broward and Palm Beach Counties. Pinellas County also experienced the fourth highest number of total deaths in the State in 2008--11,268. Pinellas County's mortality rate in recent years has slowed. However, even considering a slower growth rate in the number of deaths, Pinellas County likely will remain the fourth largest county in the State in both elderly population and number of deaths through 2015. Although it is the fourth largest service area in terms of likely hospice patients, Suncoast is the sole hospice provider in Service Area 5B. By contrast, the other three largest service areas all have multiple hospice programs to serve their large elderly populations with eight providers in Service Area 11 (Miami-Dade), five providers in Service Area 10 (Broward), and three providers in Service Area 9C (Palm Beach). In assessing the extent of utilization of hospice services in Service Area 5B, HPH through its health planner, Patricia Greenberg, noted that Suncoast appears to have over-stated its utilization rate in its semi-annual reports to AHCA. Ms. Greenberg testified that Suncoast's AHCA data includes patients who are not truly hospice patients and are, instead, patients who are participating in non-hospice programs operated by Suncoast, including palliative care programs known as "Suncoast Supportive Care" and "Hospital Support." The number of such patients was not quantified by Ms. Greenberg.3 Suncoast counters that it does not let the conditions of participation define the scope and breadth of hospice services it offers. Suncoast tries not to be defined by the Medicare conditions of participation and has programs that are not covered by the benefit, including but not limited to its residential care at Woodside and its caregiver services. Specific Terminally Ill Populations HPH identified as under-served in Service Area 5B medically complex patients with complex medical needs, including multiple IVs, wound vacs, ventilator, complex medications, or acutely uncontrolled symptoms in multiple domains. These are the same kinds of patients who would require continuous care within their homes. Hospice patients have become more highly acute in recent years. More patients are being discharged from hospitals with highly complex medical conditions, often directly from hospital intensive care units. Patients discharged directly from hospitals tend to have higher acuity levels. Ms. Greenberg reviewed Suncoast's data on hospital discharges and found Suncoast statistically lags behind HPH in caring for medically complex patients discharged from hospitals. Looking at a three-year average, HPH had 3.7 percent of its hospice discharges directly admitted from hospitals, compared to percent for Suncoast. This is more than a 50-percent deviation between hospital discharges to hospice for HPH versus Suncoast. However, a comparison of Suncoast to HPH does not establish that there is a specific underserved population in Service Area 5B which is not receiving services. One case manager testified to sometimes not being able to timely find hospice placements for medically complex patients. Such patients would then have to be transferred from the hospital to a nursing home or rehabilitation facility. However, she did not testify that this specific terminally ill population was not being served, only that they were being served somewhere other than in an in-patient hospice bed. Medically complex patients, including those needing continuous care, were another specific terminally ill population identified by HPH. At page 54 of her deposition, Deborah Casler, a case manager at Helen Ellis Hospital, addressed those populations, saying, "[w]hat I am going to say is if anybody needed continuous care through Suncoast, it would happen, but it wasn't always a quick and easy process." HPH compared its percentage of continuous care patient days with Suncoast, showing that HPH had more. That does not equate to an absence of service for any specific terminally ill population. HPH attempts to create a presumption that services are not being provided by conditioning its application on a certain percentage (3 percent) of days for continuous care patients. That is merely a projection of intent; it is not evidence that a certain population is not currently being served. Assisted Living Facility Residents HPH provided anecdotal evidence that some ALFs in Pinellas County were not pleased with the services being provided by Suncoast. One ALF administrator was dissatisfied that Suncoast took a long time to admit her resident (but the resident was ultimately admitted). Another was disappointed with Suncoast because it took a long time to get medications for her resident. Another felt like Suncoast's quality of care was inferior. HPH provides a greater percentage of hospice services to ALF residents in Pasco (12.7 percent), Hernando (26.5 percent), and Citrus (23.5) counties than Suncoast provides to ALF residents in Pinellas County. There are approximately 215 ALFs in Pinellas County of varying sizes, i.e., from three beds to almost 500 beds. Suncoast did not provide services to all of them. There was no showing, however, that any resident of an ALF who needed or requested hospice services was denied such care. None of the evidence presented by HPH establishes the existence of a group of ALF residents who were not being served in the service area; nor does the evidence prove that any specific ALF residents are, in fact, terminally ill. The 48-Hour Admission Provision Neither Suncoast, nor Odyssey presented any hard data on timeliness of admissions. In fact, none of the parties could agree as to what action constitutes an admission. Suncoast says an admission must include a physician order and a consent by the patient and family. Odyssey identifies a referral as a telephone call from a family member, even if the call is simply an inquiry as to what services might be available. Odyssey says that the majority of its patients are admitted within three hours of referral and at least 80 percent are admitted within 24 hours. During that three-hour time frame, Odyssey will contact the family, contact the physician in order to evaluate and admit, if appropriate, screen the patient to ensure he or she meets the eligibility guidelines, go out and meet with the family, and provide support while necessary information is being gathered. HPH candidly admits that the issue of admissions within 48 hours does not, in and of itself, justify the approval of a new hospice program in Service Area 5B. However, HPH argues, it is an element of hospice services that HPH would do better than the other parties. There is no credible evidence in the record that an identified number of persons in Pinellas County had not been admitted to hospice within 48 hours of referral. Statutory and Rule Review Criteria Rule Preferences The Agency is required to give preference to an applicant meeting one or more of the criteria specified in Florida Administrative Code Rule 59C-1.0355(4)(e)1 through 5: Commitment to serve populations with unmet need.-- There is no numeric need in this matter. Neither applicant proved the existence of a population with unmet need. Commitment to provide in-patient care through contract with existing health care facilities.-- Both HPH and Odyssey intend to use scatter beds and to contract with existing health care providers. Commitment to serve homeless and AIDS patients, as well as patients without caregivers.--Both applicants have shown a history of serving such groups and commit to do so in Pinellas County. Not Applicable. Commitment to provide services not covered by insurance, Medicare or Medicaid--Both applicants have a good history of providing indigent care and commit to do so in Pinellas County. Consistency with Plans; Letters of Support Florida Administrative Code Rule 59C-1.0355(5) requires consideration of the applications in light of the local and state health plans. The local health council plans are no longer a factor in this proceeding. The state health plan addresses the concept of letters of support. Again, as neither applicant proved special circumstances warranting approval of a new hospice program, this comparison is unnecessary. However, there was considerable testimony and argument at final hearing concerning letters of support and the issue deserves some discussion. Each applicant provided letters of support. In fact, HPH's application contained over 250 letters of support from a wide range of writers, including physicians, nurses, ALF and nursing home administrators, and others. AHCA even complimented HPH's letters of support in both quantity and quality. Such letters are, of course, hearsay and cannot be relied upon to make findings as to the statements made herein. However, the fact that HPH generated so many letters of support is a fact that lends additional credence to their application. Odyssey's letters of support, by comparison, were much fewer in number. The letters were also dated, having come from a CON application filed some three years prior to the application currently at issue. The content of those letters would also be hearsay. And in the present action, the age of the letters would reduce their significance as support for the Odyssey CON application at issue. Statutory Review Criteria The Agency reviews each CON application in context with the criteria set forth in Subsection 408.035(1)(a) through (j), Florida Statutes: Subsection 408.035(1)(a), Florida Statutes--The need for the health care facilities and health services being provided There was no need projected by AHCA under its need methodology. Neither party established the existence of special circumstances warranting approval of a new hospice program in Service Area 5B. Subsection 408.035(1)(b), Florida Statutes-- availability, quality of care, accessibility, and extent of utilization Suncoast is the sole provider of hospice services in Service Area 5B. This service area is one of the largest in the State. There are other service areas which have a single hospice provider, but Service Area 5B is the largest service area to be served by a single hospice provider. Service Area 5B experienced the fourth largest number of deaths in the State in 2008, an important factor in the provision of hospice care. Suncoast has 15 interdisciplinary care teams, each of which, lead by a patient-family care coordinator, includes RNs, home health aides, counselors, volunteers, and a chaplain. Suncoast has a north community service center in Palm Harbor that houses four patient care teams. On the back of that property is Brookside, Suncoast's newly built 30-bed in-patient facility. In central Pinellas County, Suncoast has its main service center with six patient care teams along with administrative and support offices. Suncoast has a pharmacy, as well as durable medical equipment and infusion departments, located in Largo. In central Pinellas County is Suncoast's ten-acre, 72-bed Woodside facility. Thirty-six of the beds are in-patient and 36 are residential. On the back of the property are 18 efficiency apartments called "Villas" with separate living, sleeping and kitchen areas. When patients become too ill to remain at home, their spouse may move into a villa until the patient dies. In the southern portion of the county is Suncoast's south community service area which houses five patient care teams, as well as "ASAP." ASAP is Suncoast's AIDS Service Association of Pinellas County which serves and provides support to patients with HIV and AIDS. Suncoast also has in-patient contracts with every hospital in Pinellas County and a number of contracts with nursing homes for in-patient care. Patients may receive continuous care in the home whether that is a residence, an ALF, or a nursing home or may receive care in the Suncoast in-patient unit. There is disagreement over whether Suncoast accurately reports its admissions and whether all reported admissions are actually hospice patients. Further, HPH points out that its penetration rate in counties where it operates is much higher than Suncoast's penetration rate in Pinellas County. However, the most credible evidence is that Suncoast is effectively serving the needs of hospice-eligible residents of Service Area 5B. Subsection 408.035(1)(c), Florida Statutes--ability to provide quality of care and record of providing quality of care Both applicants satisfy this criterion. Both applicants can provide a broad range of quality hospice services to all its patients. HPH touts its physician model, including physician home visits, as evidence of its commitment to quality care. Physician visits have been proven to help patients get pain under control more quickly, an important factor considering ten percent of hospice patients die within 48 hours of admission. Odyssey is a large company and has extensive operational policies and procedures concerning provision of quality care to its patients. Odyssey has a program called Care Beyond which it believes will enhance quality care in Service Area 5B. Odyssey has had some regulatory violations while HPH has not. However, Odyssey has resolved those violations favorably. Subsection 408.035(1)(d), Florida Statutes-- availability of resources, including health personnel, management personnel, and funds for project accomplishment and operation The parties stipulate that both applicants meet this criterion. Subsection 408.035(1)(e), Florida Statutes--extent to which proposed services will enhance access to health care for residents of the service district Both applicants satisfy this criterion. HPH is the existing provider of hospice services in the adjacent service area to Service Area 5B. HPH can use its existing contacts in Service Area 5B to extend its service to residents of that area. HPH has already established relationships with Airamed Corporation and its 11 nursing homes and ALF in Service Area 5B. HPH also commits to being more directly involved with smaller ALFs in Pinellas County. Odyssey is a large hospice with significant resources which can be utilized to enhance access for residents of Service Area 5B. It commits to bring quality personnel to Service Area 5B as part of its successful start-up procedures. Subsection 408.035(1)(f), Florida Statutes--immediate and long-term financial feasibility The parties stipulate that both applicants meet this criterion. Subsection 408.035(1)(g), Florida Statutes--extent to which proposal will foster competition that promotes quality and cost-effectiveness Both applicants are established providers of hospice services. The absence of any other hospice provider in Pinellas County means there is no effective competition. If either of the applicants was granted a CON for a new hospice in Service Area 5B, it would likely foster competition and promote quality and cost-effectiveness. Subsection 408.035(1)(h), Florida Statutes--costs and methods of construction, etc. This criterion is not applicable to the instant case. Subsection 408.035(1)(i), Florida Statutes--the applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent Both applicants meet this criterion. HPH offers extensive services that go beyond the Medicare requirements of participation. It also operates "Hospice Houses" which provide room and board to homeless hospice patients. Odyssey's record of indigent care is evidenced by the fact that approximately 55 percent of its non-Medicare net revenue is from Medicaid, and 9.5 percent of its non-Medicare services are provided to indigent patients. Subsection 408.035(1)(j)--designation as a Gold Seal Program This criterion is not applicable to the instant case. Ultimate Findings of Fact The Agency determined that there is no need for an additional hospice in the service area based upon the fixed need pool formula. Neither applicant was able to establish the existence of special circumstances warranting approval of a new hospice in the service area. There is no specific terminally ill population which is not receiving hospice services that has been identified by the applicants. There is no persuasive evidence that there is an identifiable number of individuals who were referred to hospice, but were not admitted within 48 hours.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Agency for Health Care Administration denying the CON applications of HPH South, Inc. (No. 10066), and Odyssey Healthcare of Collier County d/b/a Odyssey Healthcare of Central Florida (No. 10068). DONE AND ENTERED this 30th day of November, 2010, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of November, 2010.
The Issue The issues for determination are: (1) whether the deficiency alleged as a result of a Complaint Survey conducted on June 18, 2002, is appropriately classified as a Class I deficiency; (2) whether a fine in the amount of $10,000 is appropriate; (3) whether the "Conditional" licensure status, issued October 29, 2002, is warranted; and (4) whether the alleged violation constitutes grounds for a six-month survey requirement and $6,000 survey fee.
Findings Of Fact At all times material hereto, AHCA was the state agency responsible for evaluating nursing homes in Florida pursuant to Section 400.23(7), Florida Statutes. As such, in the instant case it is required to conduct a complaint evaluation of nursing homes in Florida in accordance with Section 400.23(8), Florida Statutes (2000). AHCA's evaluation of Florida nursing homes requires an assignment of a rating of standard or conditional to each licensee. In addition to its regulatory duties under Florida law, AHCA is the state "survey agency," which, on behalf of the federal government, monitors nursing homes that receive Medicaid or Medicare funds. Carrollwood Care Center is a nursing home located at 15002 Hutchinson Road, Tampa, Florida, and is duly-licensed under Chapter 400, Part II, Florida Statutes. On June 18, 2002, a complaint investigation survey was conducted at Carrollwood by Pamela Mraz, a surveyor for AHCA, who visited the Carrollwood facility to inquire into the death of Resident 1 that occurred on May 5, 2002. Ms. Mraz is a registered nurse (RN) with over 20 years of nursing experience, including having served as a director of nursing and having completed more than 100 surveys of long-term care facilities. She has been a surveyor for AHCA since September 2001. During the course of her complaint survey of the facility, Ms. Mraz examined the facility's records pertaining to Resident 1's death. Her review indicated that the death of Resident 1 constituted failure to meet the standards set-up under Tag F324, as identified on the Form 2567-L of the U.S. Department of Health and Human Services' Health Care Financing Administration. The parties refer to this form as the HCFA 2567-L or the "2567." The 2567 is the document used to charge nursing homes with deficiencies that violate applicable law. The 2567 identified each alleged deficiency by reference to a tag number. Each tag on the 2567 includes a narrative description of the allegations against Carrollwood and cites a provision of the relevant rule or rules in the Florida Administrative Code violated by the alleged deficiency. To protect the privacy of nursing home residents, the 2567 and this Recommended Order refer to the resident by a number (i.e., Resident 1) rather than by the name of the resident. AHCA must assign a class rating of I, II or III to any deficiency that it identifies during a survey. The rating reflects the severity of the identified deficiency, with Class I being the most severe and Class III being the least severe deficiency. There is one tag, Tag F324, at issue in the instant case, and, as a result of the complaint survey of June 18, 2002, AHCA assigned Tag F324 a Class I deficiency rating. Tag F324, reflecting the requirement of 42 C.F.R. Chapter 483.25(h)(2), requires a facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. AHCA's witness, Ms. Mraz, was asked her opinion only regarding the facility's compliance with the requirements of Tag F324. She opined that Carrollwood did not provide adequate supervision and assistance devices to prevent the accidental death of Resident 1. Resident 1's first admission to Carrollwood was on March 27, 2002. He was 89 years of age at the time of his admission, weighted 118 pounds and was 5'3" in height. He did not speak English. His initial screening assessment form reflected that he suffered with both short-term and long-term memory impairment, incontinency, decubitus ulcer, prostate cancer, malnutrition, heart problems, and was determined by Carrollwood's staff to be "bedfast" (in bed not less than 22 hours per day). Resident 1's range of motion was limited to his hands, arms and legs. Even though he could make occasional slight changes in body or extremity positions, he was unable to make frequent or significant body changes independently. Resident 1 was incapable of getting out of bed on his own, had no involuntary body movements, and required two persons to physically assist him in bed mobility. He could not use a wheel chair and experienced short periods of restlessness demonstrated by crying out in Spanish, his native language. Carrollwood's Fall Risk Assessment observation indicated that Resident 1 was virtually immobile and was, therefore, a minimum risk for falls. His assessment and care plan were adequate for his condition and comfort. Resident 1 was placed in a semi-private room with his wife. A curtain between the beds separated them. Viewed from the foot of Resident 1's bed, his wife's bed would be to the left of his bed. On the right side of his bed, an upper half side rail was placed as an enabler. On April 17, 2002, three weeks after his admission, Resident 1 was discharged to the hospital due to an increase in his temperature and congestion. On April 30, 2002, he returned from the hospital and was readmitted to Carrollwood. At this time, his second admission, he was assessed by Carrollwood's staff to be in a much weaker condition than at his initial admission, with additional diagnoses of sepsis, pneumonia, psychosis, anemia, depression and malnutrition. Upon his second admission to Carrollwood, his assessment determination changed, and Resident 1 was classified as "bed-bound," as opposed to the prior assessment of bedfast, and he required extensive assistance, at least two persons to physically assist in transferring and dressing him with use of the upper bed side rail as enablers. The doctors' notes made in conjunction with the second admission did not include the use of upper side rails as in-bed enablers. The Nurse Evaluation Assessment, dated May 1, 2002, reported that Resident 1 was completely dependent on staff for all his daily living activities, i.e., bathing, grooming, dressing, feeding, and toileting, because he could not do these functions for himself. His Resident Care Plan reflected that he had a "potential for falls due to decreased cognition and physical mobility." His bed was lowered, the head of his bed was elevated, a second mattress was added, and a pneumatic call bell was attached. With knowledge of his updated medical history and further weakened condition, the nursing staff made an independent decision to use one upper bed side rail on Resident 1's bed. The staff had received a Food and Drug Administration alert regarding potential dangers resulting from the use of side rails as recently as February 2002, and had participated in in- service training sessions concerning the use of side rails. AHCA presented no evidence of authoritative directives for "the care giver's use of side rails" in long-term care facilities. There was no evidence of statutory proscriptions, rules or accepted industry standards relating to the use of side rails in long-term care facilities. Therefore, each long-term care facility, including Carrollwood, may independently determine when, where, how and under what circumstances bed side rails will be used. Thus, AHCA's evidence of record affords no substantial basis to support its allegation that Carrollwood's decision to use an upper side rail on Resident 1's bed demonstrated a lack of adequate supervision that would cause or tend to cause immediate harm and/or death to Resident 1. Marie Gianan, RN and MDS Coordinator for Carrollwood, which included coordination of assessments and care planning since July 2000, determined that Resident 1's April 17, 2002, transfer to the hospital was a "complete discharge" from Carrollwood. According to Ms. Gianan, Carrollwood's policy, as she understands it, is that once a resident is completely discharged, his or her medical records go to medical storage. Thus, Resident 1's return on April 30, 2002, was considered and treated as a new admission requiring an original initial assessment, a new care plan and 30 days thereafter, preparation of a new MDS. The procedure, as understood by Ms. Gianan, was to not consider Resident 1's old medical records, old care plans, and old MDS, but rather to start anew based upon staff's observations, inquiries, and a check and review of current medical records and, thereafter, formulate an assessment and initial care plan within 24 hours of admission. The MDS would follow within 30 days after completion of the initial care plan. Resident 1's April 2, 2002, care plan and fall risk assessment, indicated the following: skin problems that required repositioning him in bed every two hours; bath to be given on shower day or twice weekly; dehydration requiring liquids every night; placing his bed in a low position to prevent falls due to his decreased physical mobility; providing a pneumatic call bell; and using one upper side rail as an enabler placed on his bed. The care plan for Resident 1 met all requirements and does not indicate nor support an allegation of lack of supervision or inadequate care. Ms. Gianan was adamant that Resident 1, although maybe weaker in body strength than before his discharge on May 8, 2002, was "mobile," per her interpretation of the word on his April 2, 2002, admission. She disagreed with the March 27, 2002, assessment of Resident 1 as being "immobile." Ms. Gianan has opined that, "immobile means you do not move in bed--you just stay in the position that you are put in--I do not agree with that evaluation." Carrollwood's policy permits its MDS Coordinator to independently evaluate, assess, interview and otherwise determine the status and condition of each resident. On May 5, 2002, the date of Resident 1's death, at approximately 6:45 a.m., Ann Nickerson, certified nursing assistant (CNA), entered Resident 1's room to empty his catheter. During this process, Resident 1 cried out in Spanish. His wife, awaken by the activity and Resident 1's cry, said to Ms. Nickerson "he is alright," and Ms. Nickerson completed her task and departed the room. An hour and one-half later, at approximately 8:15 a.m., Jermaine Martinez, CNA, entered Resident 1's room with his breakfast tray. Mr. Martinez found Resident 1 on the floor with his clothing pulled upward around his torso. His head was wedged between the bed's upper side rail and the mattress, with his chin resting upward against the upper side rail, thereby hyperextending his neck. Resident 1 had no pulse or respiration when found by Mr. Martinez. The Hillsborough County Medical Examiner, in an amended1 death certificate, listed Resident 1's cause of death as positional asphyxiation; the result of a lack of oxygen due to the position of his head wedged between the bed mattress and the upper side rail and hyperextension of his neck. Within a few minutes of the discovery of Resident 1 on the floor by the Mr. Martinez, Resident 1's family entered the facility for a visit and was stopped in the hall by the duty nurse who informed them of his death. During that brief period, and following the instructions given by the duty nurse, Mr. Martinez and Ms. Nickerson moved the body of Resident 1 from the floor and placed him back in his bed, pulling the cover up to his chin. Thereafter, staff contacted Carla Russo, director of nursing, for further instructions. Following instructions, staff called and released Resident 1's body to the funeral home without first notifying the Hillsborough County Medical Examiner. Because of this action, in violation of policy, no autopsy was performed on the body. It is undisputed that the facility's failure to immediately notify the Hillsborough County Medical Examiner of Resident 1's death constituted a violation of the facility's own policy and procedures regarding the death of residents at the facility. AHCA did not cite the facility for this particular facility policy violation. Therefore, there is no evidence to support an allegation of lack of supervision or inadequate care for this policy violation. Based upon the care plan, nurse's notes, and medical records, it is undisputed that staff visited Resident 1's room an average of every two and one-half hours, if not more often, to provide medications and to attend the personal needs for both Resident 1 and his wife, during each 24-hour period from April 2, 2002, to May 5, 2002. During those staff visits, while attending one occupant, staff would, could and did observe the other occupant. During those frequent room visits during the 24-hour period preceding Resident 1's demise, staff had not observed him to be restless or to independently move his body about in his bed. There is no evidence that Resident 1 was not under staff's observation, and, by implication, not under staff's supervision for any overly long period or an extended period of time of more than two and one-half hours during the April 2, 2002, through May 5, 2002, time period. The evidence does not indicate or support an allegation of lack of supervision or inadequate care by the facility. From all medical records in evidence, it is clear that during his residency in the facility, Resident 1 never exhibited the type of behaviors that would indicate to staff he was a risk for falls; he had no recorded prior history of falls at home, at the hospital or at Carrollwood, he did not use a wheelchair and he could not independently ambulate. He was never observed by staff attempting to get out of bed, and his only infrequent and occasional expressions of restlessness were "crying out" in Spanish. The evidence of record does not indicate or support an allegation of lack of supervision or inadequate care by the facility. AHCA presented no evidence of sufficient reliability to provide a plausible foundation upon which to conclude that the cause of Resident 1 moving from his bed-bound prone position to a sitting position on the floor with his neck wedged between the upper side rail and the bed mattress was due to a lack of supervision or inadequate care by the facility's staff. The evidence supports a plausible conclusion that Resident 1's demise, although inexplicable from the evidence of record, was nonetheless accidental.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing in its entirety the Administrative Complaints filed in this cause. DONE AND ENTERED this 27th day of March, 2003, in Tallahassee, Leon County, Florida. FRED L. BUCKINE 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 27th day of March, 2003.
The Issue Whether Respondent’s nursing home license should be disciplined, and whether Respondent’s nursing home license should be changed from a Standard license to a Conditional license.
Findings Of Fact Bayside Manor is a licensed nursing home located in Pensacola, Florida. On June 14, 2003, Resident No. 4 climbed out of her bed without assistance to go to the bathroom. She fell to the floor and sustained a bruise to her forehead and lacerations to her cheek and chin. Her Foley catheter was pulled out with the bulb still inflated. The fall occurred shortly after Resident No. 4 had finished eating. No staff was in her room when she climbed out of her bed. She was found on her side on the floor by staff. According to the June 14 Bayside’s Nurses' notes, Resident No. 4 stated, "Oh, I was going to the bathroom." In the hour prior to her fall, Resident No. 4 was seen at least three times by nursing assistants, which was more than appropriate monitoring for Resident No. 4. On June 20, 2002, AHCA conducted a survey of Bayside Manor’s facility. In its survey, AHCA found one alleged deficiency relating to Resident No. 4. The surveyor believed that Resident No. 4 should have been reassessed for falls by the facility and, based upon that reassessment, offered additional assistive devices and/or increased supervision. The surveyor also believed that the certified nursing assistant had left Resident No. 4 alone with the side rails to her bed down. The deficiency was cited under Tag F-324. Tag F-324 requires a facility to ensure that “[e]ach resident receives adequate supervision and assistance devices to prevent accidents.” The deficiency was classified as a Class II deficiency. On October 9, 2001, and January 14, 2002, Bayside Manor assessed Resident No. 4 as having a high risk for falls, scoring 9 on a scale where scores of 10 or higher constitute a high risk. In addition to the June 14, 2002, fall noted above, Resident No. 4 had recent falls on November 30, 2001, April 19, 2002, and May 12, 2002. Resident No. 4's diagnoses included end-stage congestive heart failure and cognitive impairment. She had periods of confusion, refused to call for assistance, and had poor safety awareness. Resident No. 4 had been referred to hospice for palliative care. Because hospice care is given when a resident is close to death, care focuses on comfort of the resident rather than aggressive care. Additionally, the resident frequently asked to be toileted even though she had a catheter inserted. She frequently attempted to toilet herself without staff assistance, which in the past had led to her falls. Often her desire to urinate did not coincide with her actual need to urinate. She was capable of feeding herself and did not require assistance with feeding. Bayside Manor addressed Resident No. 4’s high risk of falls by providing medication which eliminated bladder spasms that might increase her desire to urinate and medication to alleviate her anxiety over her desire to urinate. She was placed on the facility’s falling stars program which alerts staff to her high risk for falls and requires that staff check on her every hour. The usual standard for supervision in a nursing home is to check on residents every two hours. The facility also provided Resident No. 4 with a variety of devices to reduce her risk of falling or any injuries sustained from a fall. These devices included a lap buddy, a criss-cross belt, a roll belt while in bed, a low bed, and a body alarm. Some of the devices were discontinued because they were inappropriate for Resident No. 4. In December 2001, the roll belt was discontinued after Resident No. 4, while attempting to get out of bed, became entangled in the roll belt and strangled herself with it. On May 6, 2002, the low bed and fall mat were discontinued for Resident No. 4. The doctor ordered Resident No. 4 be placed in a bed with full side rails. The doctor discontinued the low bed because it could not be raised to a position that would help alleviate fluid build-up in Resident No. 4’s lungs caused by Resident No. 4’s congestive heart failure. Discontinuance of the low bed was also requested by hospice staff and the resident’s daughter to afford the resident more comfort in a raised bed. The fact that placement in a regular raised bed potentially could result in an increase in the seriousness of injury from a fall from that bed was obvious to any reasonable person. The May 5, 2002, nurses’ notes indicate that there was a discussion with Resident No. 4’s daughter about returning the resident to a high bed for comfort. On balance, the placement of Resident No. 4 in a regular raised bed was medically warranted, as well as reasonable. The placement in a regular bed with side rails was not noted directly in the care plan but was contained in the doctor’s orders and was well known by all the facility’s staff. There was no evidence that directly mentioned the regular bed in the formal care plan was required or that the failure to do so had any consequence to Resident No. 4’s care. Even a lack of documentation clearly would not constitute a Class II deficiency. Moreover, the bed with side rails was not ordered to protect or prevent falls by Resident No. 4. The facility does not consider a bed with side rails of any sort to be a device which assists in the prevention of falls. Indeed rails often cause falls or increase the injury from a fall. In this case, the rails were ordered so that the resident could more easily position herself in the bed to maintain a comfortable position. Again, the decision to place Resident No. 4 in a regular raised bed with side rails was reasonable. The focus is on comfort as opposed to aggressive care for hospice residents. The evidence did not demonstrate that Bayside Manor failed to adequately supervise or provide assistive devices to Resident No. 4. There was no evidence that reassessment would have shown Resident No. 4 to be at any higher risk for falls, since she was already rated as a high risk for falls. Nor did the evidence show that reassessment would have changed any of the care given to Resident No. 4 or changed the type bed in which she was most comfortable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order restoring the Respondent’s licensure status to Standard and dismissing the Administrative Complaint. DONE AND ENTERED this 3rd day of June, 2003, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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, 2003. COPIES FURNISHED: Joanna Daniels, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Donna H. Stinson, Esquire R. Davis Thomas, Jr., Esquire Broad & Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue The issues for consideration in these cases are: as to Case Number 00-3497, whether the Agency for Health Care Administration should impose an administrative fine against the Respondent's license to operate Beverly Savana Cay Manor, a nursing home in Lakeland; and, as to Case Number 00-2465, whether the Agency should issue a conditional license to the Respondent's facility effective April 28, 2000.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Agency for Health Care Administration, was the state agency in Florida responsible for the licensing of nursing homes and the regulation of the nursing home industry in this state. It is also the agency responsible for conducting surveys to monitor the compliance of nursing homes with the conditions of Medicare and Medicaid participation. Respondents, Beverly Savana Cay Manor, Inc., d/b/a Beverly Healthcare Lakeland, and Beverly Enterprises - Lakeland, are licensed by the Agency to operate a skilled nursing home at 1010 Carpenter's Way in Lakeland. On August 31, 1999, the Agency conducted an investigation into a complaint that Savana Cay had failed to provide sufficient nursing service and related services to allow residents to attain or maintain the highest practicable physical, mental, and psychosocial well-being as required by Federal rules governing Medicare and Medicaid. The Agency surveyor, Patricia Mills, observed several residents who did not have their call buttons within reach so that they could summon help if needed. Ms. Mills also talked with residents and family members and from these interviews determined that even when the resident could reach the call button and summon help, the response time was excessively long or, in some instances, the call went unheeded. This sometimes resulted in resident's suffering from the results of their incontinence because the staff did not timely respond to the help calls. Ms. Mills concluded, based on her extensive experience in surveying nursing homes, that the number of staff on duty was not sufficient to meet the residents' needs. It did not allow for the best possible well-being of the residents. Though the information related by Ms. Mills came from her interviews with residents and their families and was clearly hearsay testimony, it was admissible and considered as corroborative of her direct observation. The parties stipulated that a follow-up survey of the facility was conducted on October 13, 1999, at which time the deficiency described was deemed to have been timely corrected. The Respondent, by stipulation, does not concede the validity of this discrepancy on the August 19, 1999, survey, and the Agency does not rely on it to support the administrative fine sought to be imposed herein. Another survey of the facility was conducted by the Agency on April 26-28, 2000. On this occasion, surveyor Patricia Gold interviewed residents regarding the everyday life of the facility and reviewed resident council reports to follow up on any resident or family concerns which did not appear to have been addressed by the facility staff. During the resident interviews, Ms. Gold was advised that call lights were not answered in a timely fashion. In that connection, early on the morning of April 28, 2000, Ms. Gold observed a resident request a nurse to bring something to drink. The nurse was overheard to tell the resident the request would have to wait until she finished her report. Ms. Gold also noted on April 28, 2000, that dirty dishes were left uncollected over night in the facility common corridor and that one resident had two dirty trays left in the room. The dishes in the corridor were also seen by surveyors Donna Edwards and Marie Maisel. Based on their observations, the interviews, and the review of the council reports, the surveyors concluded that the staff on duty were insufficient in number. Another surveyor, Joanne Stewart, reviewed the resident files and medical reports of several of the residents and determined that in several cases the facility had failed to provide adequate supervision and assistive devices to prevent falls and inconsistently applied the interventions that were put in place. For example, Ms. Stewart observed Resident 12 on the floor at 2:40 p.m. on April 27, 2000. This resident, a cognitively impaired individual, had been placed in the facility from the hospital after he had sustained a fracture to his right hip and, at the time of the fall, still had staples in his hip. Ms. Stewart's review of the kardexes maintained by the certified nursing assistant (CNA) revealed there were no entries thereon indicating a need for special care to prevent this resident from falling. Although he was supposed to wear a tab alarm at all times, the facility staff knew the resident would periodically remove it, and when Ms. Stewart saw him prior to the fall, he was not wearing it. No other interventions, such as quick-release seat belts or Velcro belts, had been implemented to prevent his falls. It was just the kind of fall that he had which caused his placement in the facility and which gave rise to the need for supervision adequate to prevent further injury. He did not get the needed supervision. In fact, though the resident sustained a skin tear and bleeding of the arm as a result of the fall, the nurse who came to the scene of the fall went back to her desk and did some paperwork for between twenty and twenty-five minutes before the resident was provided any treatment for his injury. Ms. Stewart concluded the facility did not provide adequate supervision and assistance to Resident 12, and it is so found. Due to a cognitive impairment and an inability to ambulate due to an intracerebral hemorrhage, diabetes, and a cardio-vascular accident, Resident 9 was assessed at high risk for falls, and a determination was made that the resident should wear a tab alarm while in bed and in the wheelchair. During the course of her survey, Ms. Stewart observed this resident on several occasions without the tab alarm when she should have been wearing it. The resident had previously sustained falls, one of which occurred while the resident was on leave, on March 31 and April 1, 2000, but the only caveat on the CNA kardex for the resident was the caution not to leave her on the toilet alone. Ms. Stewart did not consider the supervision and assistance rendered Resident 9 to be adequate. It is so found. Ms. Edwards focused her review on the records of Resident 22 who was not at the facility at the time of the survey. The records indicated the resident had been assessed at a high risk for falls at the time of her admission and a tab alarm was used. However, according to the nurse's notes, on April 10, 2000, the alarm went off causing the resident to lose her balance and fall while in the merry walker. She lacerated her scalp and sustained a large swelling in the occipital area. The only fall assessment of this resident was done when she was admitted to the facility. The evidence does not indicate when this was, but presumably, it was not done timely. There is a requirement that fall assessments be done quarterly, but it cannot be determined when it was done here. Even when, on April 11, 2000, the day after the fall, the physical therapy staff re-screened this resident for a merry walker, no change in care notation was noted in her record or implemented. Resident 22 sustained another fall on April 16, 2000. On this occasion, the resident was found on the floor of the day room, out of the merry walker. There was no indication she was being supervised or monitored at the time of her fall. This time she sustained another head injury just above the old one. After this fall, the facility staff ordered a new merry walker even though there was no indication a different one would provide additional protection. The resident sustained a third fall on April 18, 2000, sustaining another injury to the head which resulted in substantial blood loss. As a result of this fall, she was taken to the hospital. Because of this, she was not present when the survey was done, but based on her review of the resident records, Ms. Edwards concluded that the facility did not provide sufficient supervision or assistive devices to this resident. During the period of the survey, Ms. Gold observed Resident 3 on five separate occasions. On none of them was the resident wearing a Tabs alarm even though the facility's care plan called for one to be used. A falls assessment had been started on the resident but not completed. The record also revealed that the resident fell on March 29, 2000, resulting in a skin tear to the right arm. Based on the above, Ms. Gold concluded that the resident was not provided with adequate care and assistive devices. Resident 10 was a resident with a history of falls both before and after admission to the facility. The resident's care plan called for chair alarms, a merry walker, a safety seat belt, a low bed, and a bike horn. Though Ms. Maisel, the surveyor, observed that the resident had a chair alarm, she did not see that any of the other interventions called for in the plan were provided. She did not ever see the resident with a merry walker, and on at least two occasions, she saw the resident when the chair alarm was not in use. In her opinion, the use of one intervention does not make the use of other interventions unnecessary, and she considers the facility's supervision and assistive device provision to be inadequate. Resident 4 was an individual who had sustained a hip fracture, was senile, and was taking pain medications. The resident required help in getting out of bed or a chair. The care plan for the resident called for the use of a Tabs alarm, but on none of the occasions that Ms. Stewart observed this resident was the tabs alarm in use. She considered the supervision and assistive devices provided by the facility to this resident to be inadequate. Respondent does not contest that the incidents cited by the Agency took place. Rather, it contends that the interventions implemented by it were sufficient. It also disputes the effectiveness of some interventions called for, specifically the Tabs alarms, suggesting that the alarm does not prevent falls and often contributes to them by startling the wearer. There is some evidence to support that claim. Respondent further contends that the safety provided by the use of an intervention device, such as the Tabs alarm, straps, bed rails, or the merry walker, restrictive as they are, must be weighed and evaluated against the loss of dignity of the resident caused by their use. It is also urged by the facility that the use of certain interventions such as Tabs alarms is made unnecessary when the resident is immobile and safety is provided by the use of other interventions such as bed rails, which are more pertinent to the condition of the resident. In the case of Resident 9, the failure to provide for the use of a Tabs alarm when the resident was on leave with her husband was off-set by the one-on-one supervision she received during that period. Respondent contends that falls will occur among residents of the type in issue here regardless of the planning to identify the risks of fall, the efforts made to prevent them, and the implementation and use of interventions designed to avoid them. While this may be so, the facility nonetheless has a duty to provide necessary and adequate supervision and assistive devices to minimize to the greatest extent possible, the risk of injury as the result of falls. In some cases, this was not done here. In support of its position, Respondent presented the testimony of Theresa Vogelspohl, a nursing home consultant and an agreed expert on falls, issues of the elderly, issues of care of the elderly, and nursing practices and standards in nursing homes. Ms. Vogelspohl indicated that as a general practice when patients are admitted to a nursing home they are considered at risk for falls until the facility staff gets to know them. Each facility sets its own standard as to the length of the observation period, during which the residents are studied for their gait and safety awareness. In addition, the residents are evaluated for safety awareness by the staff of the physical and occupational therapy departments. Ordinarily, the assessment includes only the minimum data set (MDS) criteria, but increasingly during the last few years, a separate falls assessment has become common. In addition to the initial assessment, the attending nurses do an independent admissions assessment, and Ms. Vogelspohl found that such an assessment process was followed as to each of the residents in issue here. Ms. Vogelspohl found that an incomplete falls assessment had been done on Resident 3. Based upon her own review of the resident's records, however, had the full assessment been completed, other than the fact that she was a new resident, the resident would have been classified as a low risk for falls. She opines that the failure to complete the falls assessment did not deny the resident any care or a care plan for falls. Ms. Vogelspohl determined that the facility had opted, instead, for a more cautious approach to this resident in the care plan which, in her opinion, was appropriate for a new admission. A care plan is a map for the staff to be made aware of the care being provided and the specific interventions pertinent to the resident. If the resident is at increased risk for falls, the care plan would list the interventions designed to decrease the risk of falls. One of the most significant risk factors for falls is increase in age. Others are disease conditions, medications, cognitive functioning levels, eyesight, and other impairments. The interventions available to a facility to address the issue of risk of falls depend upon the condition of the resident. The first consideration should be the need to maintain a safe physical environment for the resident. Appropriate footwear is important as is the availability of assistive devices such as a cane or walker. If the resident has a history of falls, consideration should be given to changing those factors which were related to the prior falls. Included in that is consideration of different seating or a more frequent toileting schedule. According to Ms. Vogelspohl, the last thing one would want to do is to apply physical restraint, but, if all else has failed, the least restrictive physical or chemical restraint may be necessary to decrease the likelihood of falls. Ms. Vogelspohl emphasizes that only the likelihood of falls can be reduced. It is not possible to prevent all falls. Room cleanliness is not something which should appear in a care plan. It is a given, and nurses know to place furniture in such a way and to reduce clutter to the extent that the resident can safely navigate the room either with a walker or a wheelchair. Obviously, in this case the survey staff concluded the placement of the dirty trays in the hallway and in the resident's room constituted a hazard. In Ms. Vogelspohl's opinion, supervision and monitoring of residents in a nursing home is a basic. That is generally the reason for the resident's being admitted in the first place. While they should be done on a routine basis, supervision and monitoring are still sometimes placed in a care plan, but the failure to have the requirements in black and white is not a discrepancy so long as the appropriate supervision and monitoring are accomplished. The residents most at risk for falls, and those who are the most difficult to manage, are those who have full physical functioning yet who have almost nonexistent cognitive functioning. Ms. Vogelspohl is of the opinion that for these residents, the best intervention is the merry walker. This is better than a regular walker because the resident cannot leave it behind. If the resident is one who falls from bed, then a low bed, with rails if appropriate, is the primary option. A low bed was called for for Resident 10 but was not provided. Ms. Vogelspohl does not have a high opinion of the Tabs alarm because it can cause as many falls as it prevents. It has a place with the cognitively aware resident who will sit back down if she or he hears the alarm sound. More often than not, however, the routine resident will automatically react by trying to get away from the noise, and, thus, be more likely to engage in rapid, impulsive behavior that can lead to a fall. Ms. Vogelspohl considers the use of the Tabs alarm as only one factor in assessing the degree of supervision provided. She looks at the care plan to see if the Tabs alarm even meets the needs of the resident. If the resident is cognitively alert and at no risk of falls, a Tabs alarm is not appropriate. There are other interventions which can be used such as quick release, velcro seat belts which better prevent falls because they provide a resistance when the resident attempts to stand up. To determine whether a care plan has been developed and implemented, Ms. Vogelspohl reviews the record. She looks at the nurse's notes and those of the social services personnel. She evaluates the records of the physical, occupational, and recreational therapy staff. Finally, she reads the resident's chart to see what staff is actually doing to implement the interventions called for in the care plan. However, on the issue of supervision, she does not expect the notes or the record to affirmatively reflect every incident of supervision. There is no standard of nursing practice that she is aware of that calls for that degree of record keeping. What she would expect to see is a record of any kind of unsafe behavior that was observed. By the same token, Ms. Vogelspohl would not expect a facility to document every time it placed an alarm unit on a resident. The units are applied and removed several times a day for bathing, clothing changes, incontinence care, and the like, and it would be unreasonable, she opines, to expect each change to be documented. Further, she considers it inappropriate and insulting to the resident to require him or her to wear an alarm when cognizant and not displaying any unsafe behavior. If a resident who is not cognitively impaired declines intervention, it would, in her opinion, be a violation of that resident's rights to put one on. In that regard, generally, interventions are noted in the resident records when initiated. Usually, however, they are not removed until the quarterly assessment, even though the intervention may be discontinued shortly after implementation. Ms. Vogelspohl took exception to Ms. Edwards' finding fault with the facility for the three falls experienced by Resident 22. The resident was under observation when the first fall occurred, but the staff member was not able to get to the resident quickly enough to catch her when she stood up and immediately toppled over in her merry walker. The resident had been properly assessed and proper interventions had been called for in the care plan. Ms. Vogelspohl attributes the fall to the resident's being frightened by the Tabs alarm going off when she stood up and believes she probably would not have fallen had she not had the tab unit on. The second fall took place while the resident got out of her marry walker in the day room. Though the day room was visible to anyone out in the hallway, the fall was not witnessed, but Ms. Vogelspohl is of the opinion that it is not reasonably possible to keep every resident under constant visual supervision unless an aide can be assigned on a one-on-one basis to every resident. On the third fall, which occurred at about 10 p.m., the staff had put the resident to bed and had put a Tabs unit on her at that time, but the resident had detached the unit and gotten out of bed. There was nothing the staff could do to prevent that. The resident was able to remove the unit no matter how it was affixed to her. Taken together, the actions taken by the facility with regard to this resident were, to Ms. Vogelspohl, appropriate. Some things could have been done differently, such as perhaps using a heavier merry walker, but she did not consider these matters as defects in the care plan, in assessment, in design, or in application. Further, she concluded that the actions taken by the facility subsequent to the first fall on April 10, 2000, wherein the resident's medications were adjusted to compensate for their effect on the resident, constituted a recognition of a change in the resident's condition which was properly addressed. Too much supervision becomes a dignity issue. There is no formula for determining how much supervision is adequate. It is a question of nursing discretion based on the individual resident. An unofficial standard in place within the industry calls for a resident to be checked on every two hours, but rarely will this be documented. Staff, mostly nurses and CNAs, are in and out of the residents' rooms on a regular basis, administering medications and giving treatments. Those visits are documented, but not every visit to a resident's room is. Resident 12, a relatively young man of 62 with several severe medical problems, sustained a fall which resulted in a fractured hip just two weeks after admission to the facility and two weeks before the survey. He was far more mobile than expected. According to the records, he was mostly cognitive intact and had been assessed for falls. As a result of this assessment, the facility developed a care plan to address his risk for falls. Implementation of the plan was difficult, however, because he was aware and could make up his own mind as to what interventions he would accept. As to the resident's April 27, 2000 fall, the only evidence in the file shows that he was found on the floor of his room in front of a straight chair, having sustained a small skin tear in addition to the fracture. From Ms. Vogelspohl's review of the record she could find no indication that the facility had failed to do something that it should have done to prevent the fall. The staff had put a Tabs alarm on the resident, and he removed it. They tried to keep his wheel chair as close to him as possible. They tried to restrict his water intake by giving him thickened liquids to reduce his trips to the rest room. He would pour out the thickened fluids and replace them with water. Because of this resident's mobility, Ms. Vogelspohl does not accept the surveyor's conclusion that the facility did not use Tabs alarms. He was able to get out of them by himself and frequently did. She is also of the opinion, in light of the way the resident behaved, that the blank kardex observed by the surveyor in no way contributed to the resident's fall. The CNA's were aware that the Tabs units were supposed to be used, and Ms. Vogelspohl has concluded that there were no more aggressive interventions that could have been used with this resident. To attempt the use of restraints, either belt or vest, would have been futile because he could have gotten out of them easily. The only other thing Ms. Vogelspohl feels could have been done was to put him in a geriatric psychiatric unit, and this was ultimately done, but not in the Respondent facility. Ms. Vogelpohl also addressed the surveyors' write- ups as they related to Residents 9, 4, 3, and 10. Resident 4 was bed-ridden as a result of Parkinson's Disease and did not need a Tabs alarm, the deficiency cited, while in bed. When seated in a wheel chair, his postural deficits were compensated for by lateral supports and a padded cushion, and she was of the opinion that a Tabs alarm was not required. She opines its absence would not have addressed his risk for falls. His January 2000 fall apparently did not relate to the failure to use a Tabs unit. Resident 3, also the subject of a write-up for failure to use a Tabs alarm, was not, in Ms. Vogelspohl's opinion, at risk for falls because she did not move around a lot due to her physical condition. Nonetheless, she experienced a fall in late March 2000 and shortly thereafter, the facility placed a Tabs alarm on her and made the appropriate entry in her care plan. Resident 9 was ambulatory only with assistance and had a special seating device to keep her in her wheel chair. After the resident sustained two falls close together, a Tabs alarm was placed on her, and from that time until the time of the survey she had no further falls. Ms. Vogelspohl contends that it was an appropriate nursing decision not to place a Tabs unit on her. The rationale for this position is not at all clear. The care plan for Resident 10, also one of the residents observed without a Tabs alarm in place, was described as "somewhat cluttered." It showed multiple interventions initiated as early as April 1999. The initial care plan was crossed through and a new one substituted in September 1999 with the family's concurrence. Nonetheless, Ms. Vogelspohl did not find it too cluttered to be understood. The evidence shows that the resident's chair was outfitted with a soft seat belt and a pressure-sensitive alarm, both of which are considered to be more effective than the Tabs alarm. Ms. Vogelspohl contends that the facility did not ignore the requirement to assess the residents for falls or the requirement to address that issue in care planning. She admits that in some cases, the plan addressing falls prevention was covered in another assessment than the one wherein it might most likely be expected, but it is her contention that if the subject is properly and thoroughly addressed somewhere in the resident's care record, that is sufficient. She considers placing it in several areas to be a redundancy and though it is frequently done so, it is done to meet a paper compliance without having any impact on the quality of care provided.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration enter a final order sustaining the Conditional license for the Respondent effective April 28, 2000, and, based only on the conditions observed at the facility on that date, imposing an administrative fine of $700.00. DONE AND ENTERED this 22nd day of March, 2001, in Tallahassee, Leon County, Florida. ___________________________________ ARNOLD H. POLLOCK 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) 921-6947 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of March, 2001. COPIES FURNISHED: Christine T. Messana, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 R. Davis Thomas, Jr., Qualified Representative Broad and Cassel 215 South Monroe Street, Suite 400 Post office Box 11300 Tallahassee, Florida 32302-1300 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
The Issue The issues for determination are whether Respondent committed the offenses set forth in the Administrative Complaints and, if so, what penalty should be imposed; and whether Respondent should be issued a Standard or Conditional license rating.
Findings Of Fact At all times material hereto, Respondent was a licensed nursing home located in Pompano Beach, Florida. Petitioner is charged with, among other things, periodically evaluating nursing home facilities and making a determination as to the degree of compliance with applicable federal regulations, and state statutes and rules. The evaluation or survey of a facility includes a resident review or survey. A resident survey consists of record review, resident observation, and interviews with family and facility staff. Review of a clinical record includes the review of a document referred to as minimum data set or MDS Assessment. The MDS Assessment is a record, in summary fashion, of information or data that a facility gathers to prepare a care plan for a resident. During the survey of a facility, if violations of regulations are found, the violations are noted and referred to as "tags." Petitioner's surveyors document the tags on a form prepared by Petitioner. Petitioner's surveyors use the "State Operations' Manual" (SOM) as guidance in determining whether a facility has violated the federal regulation 42 CFR Chapter 483. The October 1998 Survey On October 8-9, 1998, Petitioner conducted an appraisal survey of Respondent, which is not a full survey. In an appraisal survey, Petitioner's focus is on quality of care issues, making sure that the quality of care standards are met. Petitioner used nursing home survey protocols prescribed by the federal government. Petitioner's surveyor performed a resident review of Resident No. 5. Tag F309 Tag F309 incorporates the requirement of federal regulation 42 CFR Subsection 483.25, which provides that "each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care." The SOM provided, regarding 42 CFR Section 483.25, that a facility must ensure that its residents obtain optimal improvement or does not deteriorate. Therefore, the surveyor must first determine whether a resident has declined or optimally improved, and if the resident has suffered a decline or lack of improvement, determine whether the decline or lack of improvement was avoidable or unavoidable. A decline or failure to reach the highest practicable well-being is unavoidable only if: (1) the facility has an accurate and complete assessment; the facility has a care plan which is consistently implemented and based on the assessment; and (3) the facility has an evaluation of the results of the interventions and revising the interventions when necessary. Resident No. 5 was admitted to Respondent on July 9, 1998. The diagnosis for Resident No. 5 included dementia, but not severe because he could understand and follow directives, aggressive behavior, and agitated depression. He used a wheelchair and could ambulate with assistance. Respondent was required within 14 days, by July 23, 1998, to complete a MDS Assessment of Resident No. 5. Respondent assessed Resident No. 5 as being at risk for falls. Respondent was required within 21 days, by July 30, 1998, to develop a comprehensive care plan to address Resident No. 5's risk for falls. On July 29, 1998, Respondent completed and implemented the comprehensive care plan, containing interventions which included encouraging Resident No. 5 to use his call light; counseling him about his risk for falls and the need to request assistance in transfers; assisting him with transfers; instructing him about proper transfer techniques; using a night light; monitoring him for fatigue; and providing proper positioning while he was in bed or in a chair. Petitioner's surveyor reviewed, among other things, the nurses' notes and the care plan for Resident No. 5. The surveyor determined that Resident No. 5 had fallen seven times since his admission: July 18, July 23, August 7, August 14, August 17, September 26, and October 5, 1998. Two of Resident No. 5's falls occurred during the period for his MDS Assessment: July 18 and 23, 1998. Resident No. 5 suffered a skin tear to his elbow from the fall on August 14, 1998. On August 11, 1998, after his third fall on August 7, 1998, a wheelchair alarm was initiated to reduce the risk of falls. After Resident No. 5's fall on August 17, 1998, Respondent obtained an order for a lap tray. On September 28, 1998, after his sixth fall on September 26, 1998, a physical therapy screen was performed and a lap buddy was to be used in conjunction with the wheelchair alarm to reduce the risk of falls. The wheelchair alarm was to be used when the lap buddy was not in use. During the October survey, which was only three to four days after Resident No. 5's most recent fall, Petitioner's surveyor observed on two occasions that Resident No. 5 was without either a wheelchair alarm or a lap buddy. Before using the lap buddy, Resident No. 5 used a lap tray. He did not want to give-up the lap tray. Even when he was informed that the lap tray was restrictive, Resident No. 5 wanted to continue using the lap tray. A wheelchair alarm is a device, which attaches to a resident's wheelchair and is connected to the resident by a string. When the resident stands or otherwise moves from the wheelchair, the alarm sounds. The alarm's primary function is to alert the staff, not to ensure that falls will not occur, but the alarm's function is also an inhibitor and assists the staff to prevent the resident from causing himself or herself to fall. The wheelchair alarm is used only when there is a clearly demonstrated need. A lap buddy is much more restrictive than the wheelchair alarm. The lap buddy is a pillow-like device that rests in the resident's lap and discourages the resident from getting up, but the lap buddy can be removed by the resident. A more restrictive device than the lap buddy is the lap tray. The lap tray is a thin plywood board that is placed across the arms of the wheelchair and is secured to the wheelchair. The resident is capable of sliding underneath the lap tray and getting out of the wheelchair. In addition to the skin tear that Resident No. 5 suffered in his third fall on August 14, 1998, he experienced a decline in mobility requiring two people for assistance in walking instead of one person as he had before the many falls. Even though Resident No. 5 had a decline in his mental status as he had to begin taking a medication again that he stopped taking, the evidence does not demonstrate that the falls caused the decline in his mental status. Respondent failed to develop a care plan expeditiously and timely in order to address Resident No. 5's risk for falling. No evidence was presented to demonstrate that Resident No. 5 was resistant to using the interventions. Respondent had no documentation showing that the wheelchair alarm was sounding or in place at the time of Resident No. 5's fifth fall on August 17, 1998. Respondent had no documentation showing that the wheelchair alarm was in consistent use. Such documentation would have indicated that the care plan was being implemented. Respondent had no documentation showing that Resident No. 5 removed either the lap tray or lap buddy. When he fell on October 5, 1998, his seventh fall, the intervention for Resident No. 5 was the lap tray. The documentation showed that the lap tray had to be re-secured. An inference is drawn and a finding of fact is made that the lap tray was not in place when Resident No. 5 fell and that, therefore, the intervention was not consistently used. The evidence demonstrates that Respondent evaluated the results of the interventions which were used with Resident No. 5 and that Respondent revised the interventions as necessary. However, the evidence also demonstrates that the interventions were not consistently implemented. The evidence, in totality, demonstrates that Resident No. 5's decline was avoidable. Petitioner cited Respondent for committing a violation of Tag F309 and classified the violation as a Class II deficiency. Further, Petitioner assigned a federal scope and severity rating of "G" to the Tag F309 deficiency. Corrective Action After the October survey, Respondent was required to submit a plan of correction regarding Tag F309. Respondent submitted the plan of correction, indicating corrective action by October 10, 1998. The deficiency was corrected on October 10, 1998. Penalty Based upon the Class II deficiency of Tag F309, Petitioner imposed a fine of $5,000 upon Respondent. The April 1999 Survey On April 19-21, 1999, Petitioner conducted an annual survey of Respondent. An annual survey is performed at least once every 15 months. Again, the SOM was used by Petitioner's surveyors. Decisions, regarding violations, are made by the survey team. One surveyor is responsible for the resident review of a particular resident. Resident No. 3 Petitioner's resident surveyor reviewed documents and information, regarding Resident No. 3, including hospice care plan and social service notes; nurses' notes; physician orders; nurses' treatment notes; medication records; physician progress notes; comprehensive care plan, monthly summary comments; dietician's assessment; nutritional assessment; and the SOM for the pertinent tags. Petitioner's resident surveyor also made personal observations, interviewed staff, and had a consultation with a registered dietician, who was Petitioner's consultant. The survey team leader conducted the family interview. On December 10, 1998, Resident No. 3 was admitted to Respondent's facility from an acute care hospice facility. She was terminally ill and doctors were of the opinion that her clinical conditions would cause her death within six months. As a result, Resident No. 3 remained on hospice care at Respondent's facility. Resident No. 3 suffered from end-stage cardiovascular disease and congestive heart failure. She was incontinent with an indwelling Foley catheter and had contractures of the legs and Parkinson's disease. As a result of a stroke, Resident No. 3 was without speech. She was being fed through a PEG tube, which was inserted into her abdomen. Medication and hydration was also provided to her through the PEG tube. Resident No. 3 had several decubiti (pressure sores) at various stages of severity, including one at Stage IV and two at Stage III. She was receiving a continuous dose of morphine for pain caused by her compromising conditions. Resident No. 3 required total and complete assistance with all her activities of daily living (ADLs). She was completely dependent. The family of Resident No. 3 made the health care decisions for her, in particular, her son. Regarding the pressure sores, a Stage IV pressure sore had gone completely through the skin and muscle down to the bone, with nerve endings exposed. The pressure sore was open, raw, and very painful. Often the pain of such a pressure sore is described as being like very severe sun burns or almost like a bone racking kind of pain. In treating pressure sores, nutrition is one of the key components and one of the most important aspects of healing them. Development of pressure sores is related to malnutrition. During Resident No. 3's stay at the acute care hospice facility, before being admitted to Respondent's facility, Resident No. 3 experienced fluid build-up in her lungs, which was related to her end-stage cardiovascular disease and congestive heart failure. The hospice facility effectively eliminated the fluid build-up by reducing the amount of fluid intake to one can per day, which provided Resident No. 3 with 240 calories per day. For most healthy adults, 240 calories per day is insufficient to maintain body weight or promote healing of wounds or diseases. Resident No. 3's overall condition stabilized on the 240 calories per day. Upon admission to Respondent on December 10, 1998, a nutritional assessment of Resident No. 3's nutrition needs was performed by Respondent's dietician. A determination was made that, in order to meet her nutritional needs and promote weight gain and healing of her pressure sores, Resident No. 3 required 1,424 calories per day and between 37 and 56 grams of protein per day, in addition to multivitamins, vitamin C, zinc, and iron. In January 1999, Respondent's dietician reassessed Resident No. 3 for her nutritional needs. The dietician determined that no change existed in the nutritional needs for Resident No. 3, and recommended an additional, but slight, increase in the feeding amount. Around mid-January 1999, after the nutritional assessment, Resident No. 3 went into crisis care. While in crisis care, Resident No. 3's family expressed concern that she was receiving too much fluid through her feeding. Resident No. 3's physician ordered a reduction in her tube feeding to 720 calories (720 cc) per day, from six cans to three cans of formula per day. On January 25, 1999, Resident No. 3's family again expressed concern that she was receiving too much fluid through her tube feeding. The next day, Respondent's dietician and the hospice nurse met to discuss Resident No. 3's situation regarding the tube feeding. The hospice nurse informed Respondent's dietician that, during Resident No. 3's acute care at the hospice center, Resident No. 3 had experienced increased congestion and her tube feeding had been reduced to one can of formula per day and that, presently, Resident No. 3 was again experiencing increased congestion. Based upon Resident No. 3's prior experience at the hospice center with increased congestion and reduction in the amount of formula, upon the family's concern that three cans of formula per day was too much, and upon the dietician's opinion that Resident No. 3's comfort would be promoted by reducing the amount of the formula, the dietician decided to recommend reducing Resident No. 3's tube feeding. On January 26, 1999, the dietician recommended reducing the formula from three cans of formula per day to one can per day, from 720 calories (720 cc) to 240 calories (240 cc). No order was given that day by Resident No. 3's physician to reduce the tube feeding from 720 calories. The physician for Resident No. 3 was willing to reduce the formula or even discontinue it if the family of Resident No. 3 agreed. The family of Resident No. 3 were not willing to discontinue the tube feeding. Resident No. 3's physician did not order a reduction of the formula. On January 28, 1999, the physician diagnosed Resident No. 3 with pneumonia and recommended that the pneumonia be allowed to overcome her because of her terminal illness. Resident No. 3 improved and was taken off crisis care on February 3, 1999. Shortly thereafter, she began experiencing audible congestion. On February 12, 1999, Resident No. 3 was suffering from congestion, respiratory distress, and edema in her arms and thighs. On February 16, 1999, 13 days after Resident No. 3 was taken off crisis care, her physician ordered a reduction of the tube feeding to one can per day. Resident No. 3's respiratory problems became non-existent and she was removed from crisis care. Resident No. 3 remained on one can of formula, 240 calories, per day for a little over two months, from February 16, 1999, until the survey in April 1999. During that period of time, either the physician or his assistant reviewed Resident No. 3's condition and did not change her feeding order of one can per day. On February 26, 1999, Resident No. 3 was no longer congested. Her reduced feeding was not re-evaluated by Respondent to determine its necessity until the April survey. At the initial tour of Respondent by Petitioner survey team, the team member who was responsible for resident review of Resident No. 3 and who was a registered nurse observed Resident No. 3, who appeared to be a quite frail, thin and ill female, being tube fed. The feeding bag indicated that Resident No. 3 was receiving 240 calories (240 cc) per day. Resident No. 3's room had a strong odor, which the team member suspected was indicative of a skin infection, and a deodorizer can was on the floor next to Resident No. 3's bed. Respondent had no policy or procedure in place to monitor the continued necessity or advisability of such a condition as Resident No. 3's reduced feeding. The failure to have such a policy in place potentially put other residents at risk, which is a consideration of the surveyors when they make their decisions regarding the existence of a deficiency. The evidence fails to demonstrate that Respondent obtained informed consent from Resident No. 3's family for the reduced feeding. Respondent failed to fully inform the family of the effects or risks of reduced feeding on the healing of Resident No. 3's pressure sores. Respondent conducted planning meetings regarding Resident No. 3's care plan, but her health care surrogate, her son, was not invited to attend; whereas, if he was invited to attend, he would have had full knowledge of the effects or risks of the reduced feeding on the healing of her pressure sores. The evidence demonstrates that the reduced feeding in Resident No. 3's situation was not compatible with the standard of palliative care and was inconsistent with acceptable end-of- life care practices. Tag F224 Tag F224 incorporates federal regulation 42 CFR Section 483.13(c)(1)(i), which requires, in pertinent part, Respondent to "develop and implement written policies and procedures that prohibit mistreatment, neglect and abuse of residents." Neglect is defined by the SOM guidelines as "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." The SOM guidelines further provide that, on an individual basis, neglect occurs "when a resident does not receive a lack of care in one or more areas (e.g., absence of frequent monitoring for a resident known to be incontinent, resulting in being left to lie in urine or feces)." The intent of the federal regulation is provided in the SOM guidelines, which provide, in pertinent part, that the intent is "to ensure that the facility has in place an effective system that regardless of the source (staff, other residents, visitors, etc.) prevents mistreatment, neglect, and abuse of residents . . . . However, such a system cannot guarantee that a resident will not be abused; it can only assure that the facility does whatever is within its control to prevent mistreatment, neglect, and abuse of residents." Petitioner's survey team determined that Respondent did not have procedures and policies in place to prevent the "neglect" of Resident No. 3. It was within Respondent's control to attempt to ascertain medically the causative agent of Resident No. 3's congestion. Respondent failed to seek a cause, medically, of the congestion but relied upon what was related to Respondent's staff as to what occurred at the hospice facility when the hospice facility was faced with Resident No. 3's congestion. Resident No. 3's tube feeding was drastically reduced based upon this reliance. It was within Respondent's control to fully inform Resident No. 3's health care surrogate of the effects of the drastically reduced tube feeding. The evidence failed to demonstrate that her health care surrogate was fully informed by Respondent regarding the effects of the reduced feeding on her pressure sores. Resident No. 3's physician indicated that he would agree with reducing the feeding if the family agreed to the reduction. The health care surrogate, not being informed of the full ramifications, agreed to the reduction in the tube feeding. Whether Respondent provided Resident No. 3 the necessary goods and care was indeterminable by the survey team. Respondent failed to provide goods and services to Resident No. 3 necessary to avoid physical harm or mental anguish. Respondent failed to have written policies and procedures that would have prohibited neglect to Resident No. 3; however, in accordance with the SOM guidelines, the written policies and procedures could not have guaranteed that she would not have been neglected. Petitioner cited Respondent for committing a violation of Tag F224 and classified the violation as a Class II deficiency. Petitioner also assigned a federal scope and severity rating of "G" to the Tag F224 deficiency. Tag F280 Tag F280 incorporates the requirement under federal regulation 42 CFR 483.20(k)(2), which requires, in pertinent part, the development of a comprehensive care plan (Plan) within seven days of the completion of the comprehensive assessment; the Plan to be prepared by an "interdisciplinary team," which includes "the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and to the extent practicable, . . . the resident's family or . . . legal representative"; and periodic review and revision by a team of qualified persons after each assessment. Respondent failed to update or revise Resident No. 3's care plan to address the symptom of congestion, which led to the reduced feeding. Respondent failed to invite or include Resident No. 3's health care surrogate to participate in any planning of Resident No. 3's care or in any decisions regarding her nutritional needs. Petitioner cited Respondent for committing a violation of Tag F280 and classified the violation as a Class II deficiency. Petitioner also assigned a federal scope and severity rating of "G" to the Tag F280 deficiency. Tag F314 Tag F314 incorporates federal regulation 42 CFR Section 483.25(c), which requires, in pertinent part, a facility to ensure that a "resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable" and that a "resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing." The SOM guidelines define a pressure sore as "ischemic ulceration and/or necrosis of tissues overlying a bony prominence that has been subjected to pressure, friction or shear." Furthermore, the SOM guidelines provide a "staging system," which is one method of describing the extent of tissue damage, and which provides, in pertinent part, that "Stage III" is described as a "full thickness of skin is lost, exposing the subcutaneous tissues - presents as a deep crater with or without undermining adjacent tissue" and that "Stage IV" is described as a "full thickness of skin and subcutaneous tissue is lost, exposing muscle and/or bone." Pressure sores in a terminally ill patient are unavoidable. Resident No. 3's pressure sores were unavoidable due to her clinical conditions. For Resident No. 3, maintaining adequate nutrition and hydration was necessary to prevent her pressure sores from worsening, to promote healing, and to prevent infection and breakdown. Respondent drastically reduced Resident No. 3's tube feeding to 240 calories (240 cc) per day. One pressure sore had worsened from a Stage III to a Stage IV. The dead tissue in the Stage III pressure sore was removed, and as a consequence, the pressure sore enlarged to a Stage IV pressure sore. No clinical measurements were available to indicate whether the reduction in the tube feeding negatively affected Resident No. 3. Petitioner cited Respondent for committing a violation of Tag F314 and classified the violation as a Class II deficiency. Petitioner also assigned a federal scope and severity rating of "G" to the Tag F314 deficiency. The evidence is insufficient to demonstrate that Respondent committed a violation of Tag F314. Tag F325 Tag F325 incorporates federal regulation 42 CFR Section 4483.25(i), which, in pertinent part, requires a facility to ensure that a resident "maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible." Resident No. 3's clinical condition had a great impact on her nutritional status. Her tube feeding was reduced drastically to 240 calories (240 cc) per day. Respondent failed to properly discuss with and fully inform Resident No. 3's health care surrogate of the impact or effects of such a reduction. Moreover, no periodic review of the reduction was performed by Respondent, which was responsible for a care plan for Resident No. 3. The periodic examination of Resident No. 3's physician or the physician's assistant is no substitute for Respondent's responsibility for periodic review and update or revision, if necessary, of Resident No. 3's care plan. Respondent failed to "ensure" that Resident No. 3's nutritional status was maintained. Petitioner cited Respondent for committing a violation of Tag F325 and classified the violation as a Class II deficiency. Petitioner also assigned a federal scope and severity rating of "G" to the Tag F325 deficiency. Resident No. 1 Resident No. 1 was admitted to Respondent in September 1998, with a Stage IV pressure sore. Full thickness of skin and subcutaneous tissue was lost, exposing muscle and/or bone in a Stage IV pressure sore. To aid the healing of the pressure sore, Resident No. 1's physician ordered a variety of interventions, including ordering that she be given a protein supplement, Promod, in her juice twice a day. Petitioner's registered dietician, who was a member of the survey team, personally observed Resident No. 1 during at least two meals in which Resident No. 1 did not ingest the Promod. Respondent had no system in place to track whether the physician's order was being implemented. Having no such system in place, Respondent was unable to inform the physician of the ineffectiveness of the treatment modality addressing the pressure sore to enable the physician to implement a more effective alternative. During the initial tour of the facility, Petitioner's dietician noticed that Resident No. 1 had a large bruise on the left side of his forehead. The bruise was approximately the size of a quarter to a half-dollar and was a recent bruise that could have been sustained minutes or hours prior to its discovery by Petitioner's dietician. Resident No. 1 was confused and could not inform Petitioner's dietician how his forehead sustained the bruise. Respondent was unaware of the bruise until Petitioner's dietician brought the bruise to Respondent's attention. Respondent had no documentation or information on the bruise. An unknown injury report was completed after Petitioner's dietician brought the bruise to Respondent's attention. Tag F225 Tag F225 incorporates federal regulation 42 CFR 483.13(c), which provides, in pertinent part, that the facility "must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress; and that the "results of all investigations must be reported to the administrator or his designated representative and to officials in accordance with state law " Respondent should have been aware of the bruise prior to the bruise being brought to Respondent's attention by Petitioner's dietician. The bruise was quite obvious and not hidden. Respondent failed to investigate the bruise, an injury of unknown origin. When Respondent failed to investigate the bruise, a potential risk of continued harm to Resident No. 1 and of harm to other residents existed. After Petitioner's dietician, a member of the Petitioner's survey team, reported the bruise to Respondent, an investigation by Respondent ensued. Afterward, the requirements for the investigation and reporting were complied with and adhered to. Petitioner cited Respondent for committing a violation of Tag F225 and classified the violation as a Class II deficiency. Petitioner also assigned a federal scope and severity rating of "G" to the Tag F225 deficiency. Tag F314 Tag F314 incorporates federal regulation 42 CFR Section 483.25(c), which requires, in pertinent part, a facility to ensure that a "resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable" and that a "resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing." Resident No. 1's physician ordered the ingestion of Promod. Respondent failed to ensure that Resident No. 1 ingested the Promod in accordance with the physician's order. Further, Respondent had no system in place to track whether the physician's order was being implemented, and, therefore, the physician was unable to determine the type of intervention needed, if any. Petitioner cited Respondent for committing a violation of Tag F314 and classified the violation as a Class II deficiency. Petitioner also assigned a federal scope and severity rating of "G" to the Tag F314 deficiency. Corrective Action Respondent received Petitioner's survey report on April 29, 1999. The survey report contained the date by which Respondent had to correct the deficiencies, which was by April 27, 1999. The time period for Respondent to correct the deficiencies had elapsed before Respondent was notified of the date for correcting the deficiencies. Respondent submitted a plan of action to correct the deficiencies. On April 27, 1999, Petitioner visited Respondent to determine the status of the Class II deficiencies. All of the deficiencies were not corrected, but, as a result of the visit, Petitioner changed Tags F224, F225, and F280 to Class III deficiencies. On July 2, 1999, Petitioner re-surveyed Respondent. Petitioner determined that Respondent had corrected all of the deficiencies. Conditional License Based upon the Class II deficiencies of the April 1999 survey, Petitioner issued Respondent a Conditional license, effective April 21, 1999, through July 2, 1999, from the date of the survey to the date the deficiencies were corrected. Penalty Based upon the Class II deficiencies of Tags F224, F225, F314, and F325, cited as a result of the April 1999 survey, Petitioner imposed a fine of $20,000 upon Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order and therein: Dismiss the charge, as it relates to Resident No. 3 of the April 1999 survey, that Pinehurst Convalescent Center (Beverly Enterprises-Fla, Inc., d/b/a Beverly Gulf Coast- Florida) violated Tag F314, which incorporates federal regulation 42 CFR Section 483.25(c). Find that, as to the October 1998 survey, Pinehurst Convalescent Center (Beverly Enterprises-Fla, Inc., d/b/a Beverly Gulf Coast-Florida) violated Tag F309, which incorporates federal regulation 42 CFR Section 483.25, and Rule 59A-4.1288, Florida Administrative Code; and that the violation is a Class II deficiency. Find that, as to the April 1999 survey, Pinehurst Convalescent Center (Beverly Enterprises-Fla, Inc., d/b/a Beverly Gulf Coast-Florida): Violated Tag F224, which incorporates federal regulation 42 CFR Section 483.13(c)(1)(i), Subsections 400.022(1)(j), (k), and (l), Florida Statutes, and Rule 59A- 4.106(4)(x), Florida Administrative Code. Violated Tag F225, which incorporates federal regulation 42 CFR Section 483.13(c)(1)(ii), and Rule 59A- 4.106(4)(cc), Florida Administrative Code. Violated Tag F314, which incorporates federal regulation 42 CFR Section 483.25(c), Subsections 400.022(1)(j), (k), and (l), Florida Statutes, and Rule 59A-4.1288, Florida Administrative Code. Violated Tag F325, which incorporates federal regulation 42 CFR Section 483.25(i)(1), Subsection 400.022(1)(l), Florida Statutes, and Rule 59A-4.109(2), Florida Administrative Code. Impose a penalty of $2,500 for the violation committed as to the October 1998 survey. Impose a penalty of $5,000 per violation for the four violations committed as to the April 1999 survey, totaling $20,000. Uphold the change in the license rating of Pinehurst Convalescent Center (Beverly Enterprises-Fla, Inc., d/b/a Beverly Gulf Coast-Florida) to a Conditional license, effective April 21, 1999, through July 2, 1999. DONE AND ENTERED this 30th day of June, 2000, in Tallahassee, Leon County, Florida. ERROL H. POWELL 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 30th day of June, 2000.
The Issue The issues for determination are: (1) whether the noncompliance as alleged during the August 30, 2001, survey and identified as Tags F324 and F242, were Class II deficiencies; (2) whether the "Conditional" licensure status, effective August 30, 2001, to September 30, 2001, based upon noncompliance is appropriate; and (3) whether a fine in the amount of $5,000 is appropriate for the cited noncompliance
Findings Of Fact Charlotte is a nursing home located at 5405 Babcock Street, Northeast, Fort Myers, Florida, with 180 residents and is duly licensed under Chapter 400, Part II, Florida Statutes. AHCA is the state agency responsible for evaluating nursing homes in Florida pursuant to Section 400.23(7), Florida Statutes. As such, in the instant case it is required to evaluate nursing homes in Florida in accordance with Section 400.23(8), Florida Statutes (2000). AHCA evaluates all Florida nursing homes at least every 15 months and assigns a rating of standard or conditional to each licensee. In addition to its regulatory duties under Florida law, AHCA is the state "survey agency," which, on behalf of the federal government, monitors nursing homes that receive Medicaid or Medicare funds. On August 27 through 30, 2001, AHCA conducted an annual survey of Charlotte's facility and alleged that there were deficiencies. These deficiencies were organized and described in a survey report by "Tags," numbered Tag F242 and Tag F324. The results of the survey were noted on an AHCA form entitled "Statement of Deficiencies and Plan of Correction." The parties refer to this form as the HCFA 2567-L or the "2567." The 2567 is the document used to charge nursing homes with deficiencies that violate applicable law. The 2567 identified each alleged deficiency by reference to a Tag number. Each Tag on the 2567 includes a narrative description of the allegations against Charlotte and cites a provision of the relevant rule or rules in the Florida Administrative Code violated by the alleged deficiency. To protect the privacy of nursing home residents, the 2567 and this Recommended Order refer to each resident by a number (i.e., Resident 24) rather than by the name of the resident. AHCA must assign a class rating of I, II or III to any deficiency that it identifies during a survey. The ratings reflect the severity of the identified deficiency, with Class I being the most severe and Class III being the least severe deficiency. There are two Tags, F242 and F324 at issue in the instant case, and, as a result of the August 2001 survey, AHCA assigned each Tag a Class II deficiency rating and issued Charlotte a "Conditional" license effective August 30, 2001. Tag F242 Tag F242 generally alleged that Charlotte failed to meet certain quality of life requirements for the residents, based on record review, group interviews, and staff interviews, and that Charlotte failed to adequately ensure that the residents have a right to choose activities that allow them to interact with members of the community outside the facility. On or about August 24, 2001, AHCA's surveyors conducted group interviews. During these interviews, 10 of 16 residents in attendance disclosed that they had previously been permitted to participate in various activities and interact with members of the community outside the facility. They were permitted to go shopping at malls, go to the movies, and go to restaurants. Amtrans transportation vans were used to transport the residents to and from their destinations. The cost of transportation was paid by Charlotte. An average of 17 to 20 residents participated in those weekly trips to dine out with other community members at the Olive Garden and other restaurants. During those trips, Charlotte would send one activity staff member for every four to six residents. The record contains no evidence that staff nurses accompanied those select few residents on their weekly outings. The outings were enjoyed by those participants; however, not every resident desired or was able to participate in this particular activity. Since 1985, outside-the-facility activities had been the facility's written policy. However, in August 2000, one year prior to the survey, Matthew Logue became Administrator of the facility and directed his newly appointed Activities Director, Debbie Francis, to discontinue facility sponsored activities outside the facility and in its stead to institute alternative activities which are all on-site functions. Those residents who requested continuation of the opportunity to go shopping at the mall or dine out with members of the community were denied their request and given the option to have food from a restaurant brought to the facility and served in-house. The alternative provided by the facility to those residents desiring to "interact with members of the community outside the facility" was for each resident to contact the social worker, activity staff member, friends or family who would agree to take them off the facility's premises. Otherwise, the facility would assist each resident to contact Dial-A-Ride, a transportation service, for their transportation. The facility's alternative resulted in a discontinuation of all its involvement in "scheduling group activities" beyond facility premises and a discontinuation of any "facility staff members" accompanying residents on any outing beyond the facility's premises. As described by its Activities Director, Charlotte's current activities policy is designed to provide for residents' "interaction with the community members outside the facility," by having facility chosen and facility scheduled activities such as: Hospice, yard sales, barbershop groups for men and beautician's day for women, musical entertainment, antique car shows, and Brownie and Girl Guides visits. These, and other similar activities, are conducted by "community residents" who are brought onto the facility premises. According to the Activities Director, Charlotte's outside activities with transportation provided by Amtrans buses were discontinued in October of 2000 because "two to three residents had been hurt while on the out trip, or on out-trips."1 Mr. Logue's stated reason for discontinuing outside activities was, "I no longer wanted to take every member of the activities department and send them with the resident group on an outing, thereby leaving the facility understaffed with activities department employees." The evidence of record does not support Mr. Logue's assumption that "every member of the facility's activities department accompanied the residents on any weekly group outings," as argued by Charlotte in its Proposed Recommended Order. Charlotte's Administrator further disclosed that financial savings for the facility was among the factors he considered when he instructed discontinuation of trips outside the facility. "The facility does not sponsor field trips and use facility money to take people outside and too many staff members were required to facilitate the outings." During a group meeting conducted by the Survey team, residents voiced their feelings and opinions about Charlotte's no longer sponsoring the field trips on a regular basis in terms of: "feels like you're in jail," "you look forward to going out," and being "hemmed in." AHCA's survey team determined, based upon the harm noted in the Federal noncompliance, that the noncompliance should be a State deficiency because the collective harm compromised resident's ability to reach or maintain their highest level of psychosocial well being, i.e. how the residents feel about themselves and their social relationships with members of the community. Charlotte's change in its activities policy in October of 2000 failed to afford each resident "self- determination and participation" and does not afford the residents the "right to choose activities and schedules" nor to "interact with members of the community outside the facility." AHCA has proved the allegations contained in Tag F242, that Charlotte failed to meet certain quality of life requirements for the residents' self-determination and participation. By the testimonies of witnesses for AHCA and Charlotte and the documentary evidence admitted, AHCA has proven by clear and convincing evidence that Charlotte denied residents the right to choose activities and schedules consistent with their interests and has failed to permit residents to interact with members of the community outside the facility. Tag F324 As to the Federal compliance requirements, AHCA alleged that Charlotte was not in compliance with certain of those requirements regarding Tag F324, for failing to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. As to State licensure requirements of Sections 400.23(7) and (8), Florida Statutes (2000), and by operation of Florida Administrative Code, Rule 59A-4.1288, AHCA determined that Charlotte had failed to comply with State established rules, and under the Florida classification system, classified Tag F324 noncompliance as a Class II deficiency. Based upon Charlotte's patient record reviews and staff interviews, AHCA concluded that Charlotte had failed to adequately assess, develop and implement a plan of care to prevent Resident 24 from repeated falls and injuries. Resident 24 was admitted to Charlotte on April 10, 2001, at age 93, and died August 6, 2001, before AHCA's survey. He had a history of falls while living with his son before his admission. Resident 24's initial diagnoses upon admission included, among other findings, Coronary Artery Disease and generalized weakness, senile dementia, and contusion of the right hip. On April 11, 2001, Charlotte staff had Resident 24 evaluated by its occupational therapist. The evaluation included a basic standing assessment and a lower body assessment. Resident 24, at that time, was in a wheelchair due to his pre-admission right hip contusion injury. On April 12, 2001, two days after his admission, Resident 24 was found by staff on the floor, the result of an unobserved fall, and thus, no details of the fall are available. On April 23, 2001, Resident 24 was transferred to the "secured unit" of the facility. The Survey Team's review of Resident 24's Minimum Data Set, completed April 23, 2001, revealed that Resident 24 required limited assistance to transfer and to ambulate and its review of Resident 24's Resident Assessment Protocols (RAPs), completed on April 23, 2001, revealed that Resident 24 was "triggered" for falls. Charlotte's RAP stated that his risk for falls was primarily due to: (1) a history of falls within the past 30 days prior to his admission; (2) his unsteady gait; (3) his highly impaired vision; and (4) his senile dementia. On April 26, 2001, Charlotte developed a care plan for Resident 24 with the stated goal that the "[r]esident will have no falls with significant injury thru [sic] July 25, 2001," and identified those approaches Charlotte would take to ensure that Resident 24 would not continue falling. Resident 24's care plan included: (1) place a call light within his reach; (2) do a falls risk assessment; (3) monitor for hazards such as clutter and furniture in his path; (4) use of a "Merry Walker" for independent ambulation; (5) placing personal items within easy reach; (6) assistance with all transfers; and (7) give Resident 24 short and simple instructions. Charlotte's approach to achieving its goal was to use tab monitors at all times, to monitor him for unsafe behavior, to obtain physical and occupational therapy for strengthening, and to keep his room free from clutter. All factors considered, Charlotte's care plan was reasonable and comprehensive and contained those standard fall prevention measures normally employed for residents who have a history of falling. However, Resident 24's medical history and his repeated episodes of falling imposed upon Charlotte a requirement to document his records and to offer other assistance or assistive devices in an attempt to prevent future falls by this 93-year-old, senile resident who was known to be "triggered" for falls. Charlotte's care plan for Resident 24, considering the knowledge and experience they had with Resident 24's several falling episodes, failed to meet its stated goal. Charlotte's documentation revealed that Resident 24 did not use the call light provided to him, and he frequently refused to use the "Merry Walker" in his attempts of unaided ambulation. On June 28, 2001, his physician, Dr. Janick, ordered discontinuation of the "Merry Walker" due to his refusal to use it and the cost involved. A mobility monitor was ordered by his physician to assist in monitoring his movements. Charlotte's documentation did not indicate whether the monitor was actually placed on Resident 24 at any time or whether it had been discontinued. Notwithstanding Resident 24's refusal to cooperatively participate in his care plan activities, Charlotte conducted separate fall risk assessments after each of the three falls, which occurred on April 12, May 12, and June 17, 2001. In each of the three risk assessments conducted by Charlotte, Resident 24 scored above 17, which placed him in a Level II, high risk for falls category. After AHCA's surveyors reviewed the risk assessment form instruction requiring Charlotte to "[d]etermine risk category and initiate the appropriate care plan immediately," and considered that Resident 24's clinical record contained no notations that his initial care plan of April 23, 2001, had been revised, AHCA concluded that Charlotte was deficient. On May 13, 2001, Dr. Janick visited with Resident 24 and determined that "there was no reason for staff to change their approach to the care of Resident 24." Notwithstanding the motion monitors, on June 17, 2001, Resident 24 fell while walking unaided down a corridor. A staff member observed this incident and reported that while Resident 24 was walking (unaided by staff) he simply tripped over his own feet, fell and broke his hip. Charlotte should have provided "other assistance devices," or "one-on-one supervision," or "other (nonspecific) aids to prevent further falls," for a 93-year-old resident who had a residential history of falls and suffered with senile dementia. Charlotte did not document other assistive alternatives that could have been utilized for a person in the condition of Resident 24. AHCA has carried its burden of proof by clear and convincing evidence regarding the allegations contained in Tag F324.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: The Agency enter a final order upholding the assignment of the Conditional licensure status for the period of August 30, 2001 through September 30, 2001, and impose an administrative fine in the amount of $2,500 for each of the two Class II deficiencies for a total administrative fine in the amount of $5,000. DONE AND ENTERED this 13th day of February, 2003, in Tallahassee, Leon County, Florida. FRED L. BUCKINE 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 13th day of February, 2003.
The Issue Whether the applications for certificates of need filed by Petitioners Alachua General Hospital, Inc., Oakhurst Manor Nursing Corporation and Florida Convalescent Centers, Inc., meet the requirements of law and should be approved based on application of the statutory review criteria or upon other considerations.
Findings Of Fact Oakhurst Manor Nursing Center is a community-based skilled nursing facility of 120 beds located in Ocala, Florida. Oakhurst has a history of high occupancy and is a superior rated facility. At hearing, Oakhurst acknowledged a number of inaccuracies in its application. Some staffing ratios were misstated. The data utilized to calculate financial ratios is different from the data set forth in the combined statement. The physical location of the facility was incorrectly identified. The application misstated the existing number of beds in the facility. Section 408.035(1)(a), Florida Statutes, requires consideration of the need for the health care facilities and services and hospices being proposed in relation to the applicable district plan and state health plan, except in emergency circumstances which pose a threat to the public health. As to the application of Oakhurst, utilization rates indicate that need exists for additional community nursing care services in Marion County. Oakhurst experiences full occupancy. Projected occupancy levels set forth in the Oakhurst application are reasonable. The evidence establishes that the need for additional beds exists and that the application of Oakhurst is consistent with the applicable district and state health plans. Section 408.035(1)(b), Florida Statutes, requires consideration of the availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services and hospices in the service district of the applicant. Approval of the Oakhurst application will increase the availability of community nursing care at a superior rated facility and will meet the projected need determined by the AHCA's determination of the fixed pool. Section 408.035(1)(c), Florida Statutes, requires consideration of the applicant's ability to provide quality of care and the applicant's record of providing quality of care. Oakhurst is a superior rated facility with a history of providing high quality care. There is no indication that the 60 bed unit addition will result in a decline in quality of care. Section 408.035(1)(e), Florida Statutes, requires consideration of the probable economies and improvements in service that may be derived from operation of joint, cooperative, or shared health care resources. The evidence fails to establish that approval of the Oakhurst application will result in probable economies and improvements in service from joint, cooperative, or shared health care operations. Section 408.035(1)(i), Florida Statutes, requires consideration of the immediate and long-term financial feasibility of the proposal. Since purchase by the current owners, Oakhurst's financial performance has been satisfactory. Losses experienced during the two years following the purchase are attributed to accelerated depreciation. The facility is currently profitable. Although there was evidence that insufficient funds are being generated to maintain the facility's physical plant, the evidence is insufficient to establish that Oakhurst is unable to maintain the facility. Projected occupancy rates are reasonable. Funds for capital and operating expenditures are available to Oakhurst. Notwithstanding current operation of the facility and availability of funds, Oakhurst's proposal is not financially feasible. Oakhurst's revenue projections are not reasonable. This finding is based on the credible testimony of expert Charles Wysocki. Mr. Wysocki opined that the Oakhurst application is not financially feasible in the short and long term and that the financial projections in the Oakhurst application are not reliable. Mr. Wysocki's testimony was credible and persuasive. Oakhurst's current Medicaid rate is $71.68. Oakhurst application Schedule 10 projects Medicaid rates as follows: $77.41 during the construction year; $104.69 during operation year one; and $99.75 during operation year two. Oakhurst's projected Medicaid rates are unreasonable. Projected Medicaid rates are overstated and do not appear to account for Medicaid program rate ceilings. Medicaid program payment restrictions will not permit payment of such rates during years one and two. Oakhurst's current Medicare rate is $186.87. Oakhurst application Schedule 10 projects Medicare rates as follows: $340 during the construction year; $361 during operation year one; and $328 during operation year two. Oakhurst's projected Medicare rates are overstated and unreasonable. Medicare program payment restrictions will not permit payment of such rates. Oakhurst's application overstated revenue projections related to private pay patients. Further, according to Mr. Wysocki, Oakhurst has underestimated expenses related to depreciation, amortization and property taxes. Section 408.035(1)(l), Florida Statutes, requires consideration of the probable impact of the proposed project on the costs of providing health services proposed by the applicant, upon consideration of factors including, but not limited to, the effects of competition on the supply of health services being proposed and the improvements or innovations in the financing and delivery of health services which foster competition and service to promote quality assurance and cost-effectiveness. Approval of Oakhurst's application can be expected to have a positive competitive impact on the supply of services being proposed based on the fact that the addition of beds will increase the supply of appropriate placements. Section 408.035(1)(n), Florida Statutes, requires consideration of the applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent. Although Oakhurst has historically participated in the Medicaid program, Oakhurst is currently not subject to Medicaid participation requirements. If the CON at issue in this proceeding is awarded, Oakhurst will be required to provide at least half of the expanded facility's 160 beds to Medicaid patients. Section 408.035(2)(b), Florida Statutes, requires consideration of whether existing inpatient facilities providing inpatient services similar to those proposed are being used in an appropriate and efficient manner. To the extent that such information is available, there is no evidence that these services are used inappropriately or inefficiently. Section 408.035(2)(d), Florida Statutes, requires consideration of whether patients will experience serious problems in obtaining inpatient care of the type proposed in the absence of the proposed new service. As to community nursing home beds, the AHCA has determined that a need exists for additional capacity in the planning area's nursing homes. It is likely that failure to meet projected need will result in difficulty in locating appropriate placements. The state health plan sets forth "preferences" which are considered in comparative evaluations of competing CON applications. Preference is given to applicants proposing to locate nursing homes in areas within subdistricts with occupancy rates exceeding 90 percent. The occupancy rate is higher in the Alachua planning area than in the Marion planning area. Oakhurst is in the Marion planning area and has the highest occupancy in the planning area. Oakhurst meets this preference. Preference is given to applicants who propose to serve Medicaid residents in proportion to the average subdistrict-wide percentage of the nursing homes in the same subdistrict. Exceptions shall be considered for applicants who propose to exclusively serve persons with similar ethnic and cultural backgrounds or propose the development of multi-level care systems. The Marion County Medicaid participation average is 72.93 percent. Oakhurst's application subjects the facility to a 50 percent Medicaid average. Oakhurst does not meet this preference. Preference is given to applicants proposing to provide specialized services to special care residents, including AIDS residents, Alzheimer's residents, and the mentally ill. Oakhurst intends to operate a separate 20 bed subunit specializing in skin and wound care. A distinct subacute care program targeted at a specific patient population is a specialized service. Oakhurst does not have specialized Alzheimer services. Oakhurst does not provide care to AIDS patients. Oakhurst does not meet this preference. Preference is given to applicants proposing to provide a continuum of services to community residents, including but not limited to, respite care and adult day care. The Oakhurst proposal does not address respite care or adult day care. Oakhurst does not meet this preference. Preference is given to applicants proposing to construct facilities which provide maximum resident comfort and quality of care. These special features may include, but are not limited to, larger rooms, individual room temperature controls, visitors' rooms, recreation rooms, outside landscaped recreation areas, physical therapy rooms and equipment, and staff lounges. Oakhurst's application meets this preference. Preference is given to applicants proposing to provide innovative therapeutic programs which have been proven effective in enhancing the residents' physical and mental functional level and which emphasize restorative care. No party proposes to offer any therapeutic programs which may credibly be identified as "innovative." Preference is given to applicants proposing charges which do not exceed the highest Medicaid per diem rate in the subdistrict. Exceptions are be considered for facilities proposing to serve upper income residents. Oakhurst's projected rates exceed the highest Medicaid per diem rate in the subdistrict, therefore Oakhurst does not meets this preference. Preference is given to applicants with a history of providing superior resident care programs in existing facilities in Florida or other states. HRS' evaluation of existing facilities shall consider, but not be limited to, current ratings of licensure facilities located in Florida. AHCA is the successor agency to HRS. All applications meet this preference. Preference is given to applicants proposing staffing levels which exceed the minimum staffing standards contained in licensure administrative rules. Applicants proposing higher ratios of RNs- and LPNs-to-residents than other applicants shall be given preference. Although FCC and Oakhurst propose reasonable staff levels, Alachua's hospital-based unit, by virtue of location, more closely meets this preference than FCC or Oakhurst. Preference is given to applicants who will use professionals from a variety of disciplines to meet the residents' needs for social services, specialized therapies, nutrition, recreation activities, and spiritual guidance. These professionals include physical therapists, mental health nurses, and social workers. All applications meet this preference. Preference is given to applicants who document plans to will ensure residents' rights and privacy, to use resident councils, and to implement a well-designed quality-assurance and discharge-planning program. All applications meet this preference. Preference is given to applicants proposing lower administrative costs and higher resident care costs compared to the average nursing home in the district. Oakhurst has higher administrative costs and lower resident care costs compared to the average nursing home in the district. Oakhurst does not meet this preference. The district health plan sets forth preferences which are to be considered in comparative evaluations of CON applications. The first applicable district preference is directed toward providing geographic access to nursing home beds. None of the applications meet this preference. The second applicable district preference requires consideration of existing bed utilization. Based on the percentage of elderly population and utilization of existing beds in each area, relative priorities are established. Oakhurst is in a "high need" planning area. Existing nursing homes in the Marion planning area are experiencing occupancy levels between 80 and 90 percent placing Oakhurst in a "moderate occupancy" planning area. According to the preference matrix set forth in the district plan, Oakhurst is in a priority two planning area (high need and moderate occupancy.) The evidence establishes that Oakhurst meets this preference. The third preference relates to the conversion of acute care beds to skilled nursing use. Oakhurst does not intend to convert underutilized hospital beds into skilled nursing beds for step-down or subacute care. The fourth and fifth preferences apply to new facilities of at least 60 beds. No application meets these preferences. The sixth preference states that priority consideration should be given to facilities which propose to offer specialized services to meet the needs of the identified population. Oakhurst proposes to offer a subunit specializing in skin and wound care. Oakhurst meets this preference.
Recommendation RECOMMENDED that a Final Order be entered determining the application of Oakhurst Manor Nursing Center for Certificate of Need #7326 to be incomplete and withdrawn, GRANTING the application of Florida Convalescent Centers, Inc., for Certificate of Need #7325 for the 60 remaining beds in the applicable fixed need pool and GRANTING the application of Alachua General Hospital for Certificate of Need #7320 to convert 30 existing acute care beds into a skilled nursing unit. DONE and RECOMMENDED this 5th day of October, 1994, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of October, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-6264 To comply with the requirements of Section 120.59(2), Florida Statutes, the following constitute rulings on proposed findings of facts submitted by the parties. Alachua General Hospital, Inc.'s proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 15. Rejected, irrelevant as to the AHCA's review of the proposals prior to notice of intended award. 16, 20. Rejected, unnecessary. 21-26. Rejected, subordinate. 30. Rejected, recitation of testimony is not finding of fact. 32, 34. Rejected, subordinate. 42-50. Rejected, not supported by the evidence. The preferences set forth in the proposed finding are not those contained within Alachua's exhibit #1, which has been utilized in this Recommended Order. 52. Rejected, immaterial. Rejected, recitation of testimony is not finding of fact. Rejected, evidence fails to establish that therapy offered is "innovative." 62. Rejected, cumulative. 63-64. Rejected, subordinate. 72. Rejected as to SAAR, unnecessary. 73-76. Rejected, recitation of testimony is not finding of fact. Oakhurst Manor Nursing Corp.'s proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 4,6, 8-51. Rejected, unnecessary, application rejected as incomplete and withdrawn from consideration. 52-54, 56-58. Rejected, irrelevant. Although it is true that the application contained the combined audited financial statements for the Harborside facilities, such statement fails to meet the requirement that the application contain an audited financial statement for the applicant. Harborside is not the applicant. 55. Rejected, irrelevant. The agency has cited no authority which would permit the waiver of the statutory requirement. 59. Rejected, immaterial. The document was admitted to demonstrate that the material required by law was not submitted with the CON application. Further consideration constitutes an impermissible amendment to the CON application and is rejected. Florida Convalescent Centers, Inc.'s proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 3. Rejected, unnecessary. 5-91. Rejected. The Oakhurst application has been rejected as incomplete and treated herein as having been withdrawn. 93. Rejected, unnecessary. 102-143. References to Oakhurst application, rejected, unnecessary. Agency for Health Care Administration's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 3. Rejected, irrelevant. 4-5. Rejected, unnecessary. 6. Rejected, subordinate. Rejected. The Oakhurst application has been rejected as incomplete and treated herein as having been withdrawn. Rejected, not supported by the greater weight of evidence. 13-16. Rejected. The Oakhurst application has been rejected as incomplete and treated herein as having been withdrawn. 19. Rejected, contrary to the comparative review contained herein. Rejected, contrary to the greater weight of the evidence, wherein the CON application sets forth such information. Rejected, unnecessary. The Oakhurst application has been rejected as incomplete and treated herein as having been withdrawn. Comparison is inappropriate. Rejected, contrary to the comparative review contained herein. Rejected, contrary to the evidence. The CON application sets forth the information which the agency asserts was not provided. Rejected, contrary to the comparative review contained herein. Rejected, contrary to the evidence as related to applicable criteria for review set forth in the statute. 35. Rejected, not supported by credible evidence or the administrative rules cited in the proposed finding of fact. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 Dean Bunton, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 R. Terry Rigsby, Esquire Geoffrey D. Smith, Esquire BLANK, RIGSBY & MEENAN 204 South Monroe Street Tallahassee, Florida 32302 Gerald Sternstein, Esquire Frank Rainer, Esquire RUDEN, BARNETT, McCLOSKY, SMITH 215 South Monroe Street Barnett Bank Building, Suite 815 Tallahassee, Florida 32301 Alfred W. Clark, Esquire 117 South Gadsden Street, Suite 201 Tallahassee, FL 32301
