Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
The Issue Whether Respondent skilled nursing facility is guilty of the deficiencies cited in the Agency for Health Care Administration's (AHCA's) October 20-24, 2003, survey for (a) failing to provide proper daily tracheostomy care for two identified patients; (b) failing to have emergency tracheostomy equipment available; and (c) failing to have properly trained staff available to use the emergency equipment. See 42 CFR § 483.25(k); Whether AHCA properly assigned a conditional licensure status to Respondent until such time as the deficiencies were found to be corrected. See § 400.23(7), Fla. Stat.; Whether AHCA properly imposed an administrative fine of $15,000.00, based on its finding that the deficiencies were "widespread, Class I" deficiencies. See § 400.23(8)(c), Fla. Stat.; and Whether AHCA properly imposed a six-month cycle survey fee of $6,000.00. See § 400.19(3), Fla. Stat.
Findings Of Fact Petitioner AHCA is the state agency responsible for licensure and regulation of Florida nursing homes. As such, AHCA administers all applicable Federal regulations and State statutes and rules. Respondent Marshall operates a licensed skilled nursing facility at 207 Marshall Drive, Perry, Florida 32347. The standard form used by AHCA to document survey findings is known as a "2567" form, titled "Statement of Deficiencies and Plan of Correction." A nursing home facility deficiency is noted by compliance surveyors on the 2567 form and referred to as a "Tag." AHCA conducted an annual survey of Respondent Marshall, pursuant to Section 400.23, Florida Statutes, on October 20 through 24, 2003. As a result of that survey, AHCA charged Marshall with a violation of Tag F328. AHCA deemed this deficiency to be widespread and to place patients in “immediate jeopardy”.1/ This allegation, if true, constitutes a Class I deficiency. Class I is the most severe of deficiencies, indicating a deficiency which "the Agency determines presents a situation in which immediate corrective action is necessary because the facility's noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident receiving care in a facility."2/ AHCA's finding of “immediate jeopardy” was removed on October 22, 2003, while the survey was still in progress. AHCA imposed a "conditional" license on Respondent, effective the last day of the survey, October 24, 2003. Respondent submitted a Plan of Correction. AHCA conducted a follow-up survey at Respondent's facility on December 4, 2003, and determined that the alleged deficiencies had been corrected, as of that date, and restored Respondent's standard license, effective that date. AHCA’s deficiency citations primarily address the care provided to two residents, identified as Resident 10 and Resident 16, both of whom had tracheostomy, or tracheotomy, tubes. The cited deficiencies turn on the provision of "trach" care to those two residents, who were the only residents at Respondent Marshall who had such tubes on the dates of the survey. For purposes of this case, "tracheostomy" and "tracheotomy" may be used interchangeably, and "trach" is an acceptable commonly-used abbreviation. During the survey in question, Respondent Marshall was also cited for failure to meet the standard of care for Resident 6, who was on a gastrointestinal feeding tube, commonly called a "G-tube," inserted in her stomach. A tracheostomy or tracheotomy is an incision made in the neck to create an air passage through the neck and into the trachea (wind pipe). The procedure is commonly done for persons who are unable to breathe independently or who require assistance in breathing. The air passage itself (the resulting hole) is called a “stoma." Although some persons are able to breath through a stoma without mechanical devices, it is common to have this airway maintained by the insertion of a “trach tube.” The trach tube consists of two parts. The first is an outer cannula (tube) that has a flange that rests on the outside of the patient's neck. The flange is held in place by cloth or Velcro strips that attach to the outer cannula and which are tied or secured around the patient's neck to hold the device in place. The outer cannula has a tube that goes through the resident’s neck and opens into the trachea. Both of the residents at issue in this proceeding had “Shiley” trach tubes. The outer cannula of a “Shiley” trach has a balloon-type apparatus, called a “cuff,” on the inside of the resident’s trachea. The outer cannula is inserted through the stoma with cuff uninflated. Once inserted, the cuff can be inflated with air to hold the cannula in place from the inside. The second part of the trach tube is the inner cannula. The inner cannula is a slightly smaller tube inserted into the outer cannula and locked or snapped into place. The patient receives air through this latter tube. For more severely injured patients, the trach can be attached to a ventilator to provide all of the breathing function; otherwise, the trach can be attached to an oxygen canister, to provide a supplemental source of oxygen-enriched air to the patient's lungs. The trach also can serve as a supplemental source of air to the lungs of persons who are unable to inhale sufficient air through their nose or mouth. Finally, a trach is used to manage secretions in the lungs and airways. This is done by inserting a suction tube through the inner cannula and into the airway. If the inner cannula becomes clogged by secretions or by a foreign object, the inner cannula can be removed from the outer cannula, opened and cleaned, and reinserted. Improper or overzealous suctioning can cause irritation or bleeding or can even dislodge the stoma. One potential problem for persons with trach tubes is the possibility that the tube will come out of the neck, or "extubate." Extubation may result if a resident deliberately or inadvertently pulls out his trach tube, or the tube may be coughed out, even if the ties are in place. Although not common, extubation does occur. That extubation will occur at some time is not unexpected. However, extubation customarily occurs suddenly and without warning. When it occurs, extubation presents a crisis situation requiring immediate, skilled intervention. Most times that a trach tube becomes dislodged the stoma remains functional without the tube. If the stoma closes, a patient who relies wholly on a trach tube for an air supply will have no source of air. Without oxygen, brain damage can occur within four to eight minutes. Other patient oxygen deprivation problems include loss of consciousness, cardiopulmonary arrest, coma, and even death. Some patients are able to at least partially breathe without a trach tube or an open stoma. Such patients would have a limited source of air after extubation and would not experience brain damage until more than eight minutes had passed. Whether an extubation would result in death or serious injury depends upon how much air the patient can still get and upon the condition of the individual patient. When extubation occurs, the first priority is to establish an open airway. If the stoma remains open without the trach tube, a "patent" (clear) airway exists. If the stoma closes, the attending nurse can attempt to reinsert the dislodged trach tube. "Kelly clamps" (a type of hemostat) are sometimes used to hold the airway open, thus facilitating threading a new tube in place. If the stoma has partially closed, the opening may be too small to reinsert the previous trach tube. For that reason, the standard of care is to have an emergency trach kit with either an opturator (a device for inserting trach tubes) or a smaller size trach tube on hand at each trach patient's bedside. If the stoma has closed, and a trach tube cannot be inserted, the patient can be maintained by an “ambu-bag.” An ambu-bag consists of an oxygen-pumping device which can be attached to a mask that fits over the patient's nose and mouth, but it can also be used by attaching it to the stoma itself. This latter method can only be used with a well-healed stoma. Placed in the stoma, the ambu-bag can be pumped manually by a health care provider to force air into the lungs. Trach patients are not common in a long-term care setting, such as Respondent's facility. Such facilities seldom have more than one or two such patients simultaneously. Respondent's Residents 10 and 16 had trach tubes, essentially to manage their secretions. On the first day of the survey, the Respondent facility had available on the premises ambu-bags, suctioning devices, and oxygen tanks, but these were not attached to the trach patients' beds or head boards, as would be an appropriate and standard practice. On the first day of the survey, the surveyors were unable to locate any obturators, spare trach tubes, Kelly clamps or other trach supplies anywhere in the facility. Respondent Marshall had a policy that required emergency trach supplies, including a trach tube, to be maintained at each trach patient's bedside at all times. This policy is consistent with the applicable nursing practice standard of care, which requires that all trach patients shall have emergency supplies/emergency trach kits (including outer tube, inner cannula and obturator), and Kelly clamps available at bedside. The applicable standard of care under which Respondent was cited for a deficiency requires facilities to ensure that emergency trach supplies are immediately available to staff. Apparently, this standard of care considers that the emergency trach supplies should include a spare trach tube of the proper size and an obturator. Because obturators come in different sizes, to correspond with the size of the patient's trach tube, it is essential to have both the correct size tube and the correct size obturator if one attempts to reinsert a trach. The wrong size equipment can result in an unsuccessful reinsertion and can cause injury to the patient. The surveyors asked Marshall's Director of Nursing (DON) whether she could locate emergency equipment, and the DON was also unable to find emergency trach kits or Kelley clamps. Oxygen was available, but the nursing staff was at least somewhat lacking in experience or knowledge of how to use it with a trach patient. See infra. Resident 10 was a younger resident who had suffered a diving accident. He suffered from hypoventilation syndrome, and probably damage to his cervical spine had compromised his respiration. When he arrived at Respondent Marshall, he was paralyzed from the neck down and had quadriplegia. He was frequently non-compliant with his care, but was active, in that he sat in his motorized wheelchair out on the facility's patio and visited with friends. Because he was in a wheelchair, it would have been "typical" and good judgment to have an emergency trach kit attached to his wheelchair, as well as at his bedside. However, one was not attached. There also was no call mechanism available to him from the wheelchair on the patio. There was a "face kit" (a mask not attached to an ambu-bag) in Resident 10's room, but there was no full trach kit in his room. Due to his quadriplegia, Resident 10 could not manually remove his own trach tube, but due to its having been recently installed, his incision was not fully healed, and his stoma could be considered unstable. Due to his activity level, extubation was a real possibility for Resident 10. Resident 10 was observed to have a lot of coughing and thick secretions. Although the weakness of his cough suggested that it would be unlikely that he would be able to cough his trach tube out, the thickness of his secretions had once obstructed his stoma and continued to make another obstruction of his stoma more likely than not. There was a physician’s order that nursing staff perform routine trach care for Resident 10 on every shift. When the October 2003 surveyors asked about his care, Resident 10 stated that he did not receive trach care on every shift. In order to confirm this absence of care, the surveyors reviewed Resident 10's Treatment Administration Record (TAR,) which the surveyors concluded confirmed that Resident 10 had not been given routine trach care on 37 of 75 shifts since his admission. What the surveyors missed, was that the TAR also contained a notation "Suction trach every 4 hours while awake," then notes "on med sheet," and that the TAR contained two additional entries for trach care. Respondent Marshall also had documented trach care in the nurses' notes during the month of October 2003, up until the time of the survey, on 37 occasions. The Medication Record (MAR) further reveals 14 documented times that Resident 10 was provided routine trach care. Therefore, instead of 33 incidents of trach care during the first 22 days of October, as the surveyors believed, the complete records contain 86 entries for trach care rendered to Resident 10. While the Respondent facility's record-keeping leaves something to be desired, Respondent was not cited for that reason, and the trach care actually ordered for Resident 10 appears to have been provided. Resident 16 was completely bed-bound, unresponsive, and unable to self-advocate. She relied on facility personnel to provide all of her activities of daily living. She had been admitted to Respondent Marshall with a trach tube inserted, as a result of a stroke. Nurses' notes revealed that she had experienced some blood in her sputum and had once pulled her G- tube out. This information led the surveyors to question whether Resident 16 had a predisposition to remove all tubes and to believe that Resident 16 would, therefore, be at greater risk for removing her trach tube as well. Also, one opinion advanced concerning Resident 16's condition was that although the bleeding recorded in the nurses' notes was not reported in excessive amounts, it could have become excessive. This suggests that it was not Resident 16's condition, as of the date of the survey at issue here, that caused the deficiency citation, but that a deficiency was assigned, in part, because the blood in Resident 16's sputum could worsen and her bleeding could become excessive. Blood in sputum is not an unusual occurrence in trach patients. It is only when the blood is consistent and regular that it becomes cause for concern. In fact, Resident 16's problem in regard to blood in her sputum had been addressed by Respondent's nursing staff. The nurses' notes reflect that on October 17 and 19, 2003, Resident 16 had "traces" of blood in her sputum; "coughed up very sm. Amt. Blood tinged mucous"; and "continues [with] blood tinged mucous." It was described by the one witness who actually observed it as "very pink, light pink." The DON had been made aware of Resident 16's condition and had personally monitored it. When the condition persisted and somewhat worsened on October 21, 2003, the second day of the survey, Resident 16's physician was notified and she was sent to the hospital for observation and treatment. Although her condition could have been the result of improper suctioning, Resident 16 was discharged from the hospital to another long- term nursing facility with no clear assignment of cause and no assignment of blame. During the survey at issue here, AHCA surveyors interviewed three nurses in order to evaluate their competence vis-à-vis trach care. One nurse erroneously stated that she thought a Shiley cuff was inflated with saline solution. Although that nurse never actually put saline solution in a cuff, to do so would have damaged any trach tube and caused harm. It would also have delayed proper trach care and the delay could have been fatal to the patient. Another nurse answered the question of how she would respond to a trach emergency by stating that she might put a pen or a straw in the stoma until emergency medical services arrived. A third nurse stated that she felt comfortable doing routine trach care, but would not feel comfortable doing emergency care. These three responses led AHCA to question trach competency of the entire facility nursing staff. On the second day of the survey, AHCA declared a state of "immediate jeopardy" at Respondent Marshall, based on the absence of emergency equipment and the surveyors' perception that staff were inadequately trained to deal with trach emergencies. Additional concerns were the mis-perceived lack of routine care to Resident 10 (see Findings of Fact 31-33) and the failure to act more aggressively with regard to the blood in Resident 16's sputum. Surveyors did not interview all of Respondent's nurses, and therefore, they did not assess the overall abilities of the staff, but surveyors are only required to take a sampling of staff. Even if AHCA now concedes that Marshall employed at least two nurses fully able to provide trach care, it is not reasonable to assume that these two nurses, one of whom was the DON, were providing adequate care for Residents 10 and 16 on every shift (24 hours a day, 7 days a week), prior to the deficiency citations. No comfort that adequate emergency trach care was regularly being provided on every shift, prior to the deficiency citation, is provided by the DON's testimony concerning what she would and would not do herself and what she would and would not allow her nurses to do. (See Finding of Fact 41.) Considering the number of shifts in place; the evidence as a whole reflecting that the DON provided individual training in trach care only to her nurses when they asked for it; and a potential 50 percent per year estimated employee turnover, Respondent really needed to require that all of its nursing staff earn continuing medical education (CME) credits in trach care. Regular CME training would have insured protection against the inevitability that the skills of nurses competent to provide trach care immediately after hire or immediately after special training would not diminish over time or that such nurses might leave the facility. Respondent contended that even if Resident 10 or 16 extubated, the stoma closed, and the resident lost the ability to breathe independently, paramedics from a nearby hospital could arrive within three to four minutes, ambu-bag the resident, and transport the resident to the hospital's emergency room in seven to eight minutes, total time. However, four to eight minutes is on the cusp of the expected brain damage margin. Only use of the ambu-bag would make a significant difference. A successful scenario such as Respondent envisions, assumes there would be no confusion, hesitancy, or delay by Respondent's nurses in notifying the hospital or by paramedics in their arrival. Given the lack of trach training of staff, a successful scenario is less likely than likely. In the absence of ambu-bags, suctioning devices, and emergency trach kits at each trach patient's bedside, Respondent's dependence on outside paramedics might be its only alternative, but that outside alternative, as chancy as it would be, does not reduce Respondent's responsibility. In this context, it should be noted that part of Respondent Marshall's emergency trach protocol was to call 911 before attempting reintubation. However, Respondent's DON would let her nurses use an ambu-bag but would not let them use an obturator. The DON and one other nurse were trained on the obturator, but had never actually placed one. It is of concern, too, that the DON seemed to assume that placing a mask and tube over the patient's face constituted the only proper use of an ambu-bag, when, in fact, attaching the ambu-bag to the stoma and doing manual squeezing is another technique. Respondent provided medical evidence from the treating physician that both Resident 10's and 16's stomas would remain open under all circumstances. However, the foregoing opinion is not persuasive, considering the other contrary medical and nursing testimony and the evidence as a whole. It was also proven that Respondent failed to abide by the standard of care by providing less frequent cleaning of Resident 6's G-tube than had been ordered by the attending physician, and that on occasion, soap and water, rather than the ordered hydrogen peroxide was used to clean Resident 6's apparatus and opening. Lack of sanitary and consistent G-tube care can result in infection to the skin, blood system, or peritoneal cavity, which is the normally sterile abdominal cavity containing the intestines, stomach, liver, and other organs. However, it was shown that the care related to this resident was only a supplemental, tangential cause of AHCA's finding of "immediate jeopardy." AHCA must evaluate the scope of a violation as being isolated, patterned, or widespread. In this particular survey, AHCA alleged that the violation was "widespread," in accord with the Agency policy of determining the scope of a deficiency based on the population of residents receiving a particular service, as opposed to being based on the facility's entire patient population. Here, AHCA designated the two trach residents as "special needs" patients. Determining that all of the two trach tube/special needs patients received deficient care, AHCA deemed the violation to be "widespread." No contrary evidence was offered, and the Agency policy is not unreasonable. AHCA evaluated the trach care provided by Respondent as having a severity of "immediate jeopardy" and "likely to cause serious harm, injury, impairment, or death" to the residents involved. In so doing , AHCA presumed a greater likelihood than not that a trach emergency would occur. Medical witnesses opined similarly, but Respondent has argued that this "likelihood" is an "assumption," in the nature of an unauthorized legal presumption. Rather, it is found to be simply reasonable that AHCA should conduct surveys based on "worst case scenarios" when assessing a facility's readiness for health care emergencies involving the most vulnerable components of that facility's patient population, as was done here. This methodology is also in line with the statutes' classification system that ranks citations of deficiency in terms of those which have caused or are likely to cause serious injury, harm, impairment, or death to a resident in care. A similar analysis was also opined by Dr. Nace, who defined "likely" as "a credible event or situation with no assignment of probability." The deficient practices were identified to Respondent's staff on the second day of the survey, October 22, 2003. All witnesses testified that Respondent acted quickly and aggressively by correcting the problems noted. The DON obtained emergency trach kits from the hospital, rearranged the staffing schedule so that AHCA was satisfied that a competent trach trained person was available 24 hours a day, seven days a week; and arranged for a respiratory therapist to provide in-service training to all nurses on staff. As a result, the "immediate jeopardy" classification was lifted on October 23, 2003. All of the care observed by surveyors after that date was proper. Therefore, it appears that including the date the deficient practice was identified and the day on which the deficiency was cleared, to the satisfaction of the surveyors, constituted only approximately 24 hours.
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 which ratifies the assignment of the conditional licensure status from October 24, 2003, to December 3, 2003; the $15,000 fine for a single Class I deficiency; the six months' survey cycle, and the $6,000 re- survey fee. DONE AND ENTERED this 13th day of June, 2005, in Tallahassee, Leon County, Florida. S ELLA JANE P. DAVIS 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 June, 2005.
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale. Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee. At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000. In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail. At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle. Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling. Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed. Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary. Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible. Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon. After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI. Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for review in accordance with Subsection 440.13(1)(m), Florida Statutes. AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code. Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner. Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him. AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes. The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint. The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks. Genzyme returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted in the wounded cartilage and covered with the periosteal flap. The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient. Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure. Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI. Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee. The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed. Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail. There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind. The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way. Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being. AHCA stipulates and the evidence establishes that ACI has been established to be safe. Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.
Recommendation Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner. DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
The Issue The issue in this case is whether Jose Rosado, M.D., (Respondent), violated Section 458.331(1)(t), and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Florida law. At all times material to these proceedings, Respondent has been a licensed physician in the State of Florida, having been issued license number ME 0068035. Respondent is board-certified in internal medicine and cardiovascular diseases. On March 10, 1997, Patient W.B.C., a 72-year-old man, arrived at the Leesburg Regional Medical Center (LRMC) emergency room. He complained of a sudden onset of weakness in his left hand and arm with numbness and tingling. Respondent was Patient W.B.C.'s primary care physician. Respondent admitted Patient W.B.C. with a diagnosis of cerebrovascular accident, mitral regurgitation, sick sinus syndrome and a history of myocardial infarction. Respondent ordered that Patient W.B.C. undergo a head CT scan, carotid Doppler, 2-D echocardiogram, an electroencephalogram, and a neurological consultation. Based on the test results and the consultation, Respondent diagnosed Patient W.B.C. with right cerebrovascular accident, mitral regurgitation, sick sinus syndrome, and history of myocardial infarction. Respondent then discharged the patient with Ticlid, a medication to prevent further cerebrovascular accidents and aspirin. On March 16, 1997, Patient W.B.C. was admitted to LRMC complaining of weakness, dizziness and a fever. His vital signs revealed a temperature of 103.0 F, a pulse of 118, and a blood pressure of 139/75. The emergency room physician ordered a chest x-ray, EKG, and urine and blood cultures. The chest x-ray revealed no acute cardiopulmonary abnormality. Urine tests revealed features consistent with the possibility of urosepsis. Blood work showed a white blood count of 9.15, elevated but within the normal range. Also on March 16, Respondent ordered that antibiotics be given prophylactically until the blood cultures came back from the laboratory. The cultures came back positive for staphylococcus aureus (staph). Staph is a notoriously “bad bug” and Staphylococci aureus bacteremia has a high mortality rate. Staph aureus can originate from several possible sources including infections through the urinary tract system, IV sites, aspiration into the lungs, and pneumonia (although not very common). Staphylococci in the bloodstream is known as bacteremia. Bacteremia can lead to endocarditis which is an infection of the inner lining of the heart and the heart valves. Endocarditis is a life-threatening condition that can quickly damage the heart valves and lead to heart failure or even death. Patients with certain cardiac conditions such as mitral valve regurgitation have a higher risk of developing endocarditis. Patient W.B.C. had such a history. On March 17, 1997, Patient W.B.C. was started on intravenous antibiotics by Respondent. Patient W.B.C. continued to receive the intravenous antibiotics for four days from March 17, 1997, through March 20, 1997. Respondent then switched Patient W.B.C. to oral antibiotics and kept the patient in the hospital one more day prior to discharging him with instruction to continue on the oral antibiotics for another ten days. Patient W.B.C. was discharged on March 21, 1997. He was not referred to an infectious disease specialist nor had Respondent obtained a consultation with any specialist to determine the length of time that the patient's infection should be treated. Respondent felt that he was adequately qualified to treat this patient, and the treatment appeared to work. Respondent thought the bacteria growing in the patient's blood "likely" originated from a lung infection. An infectious disease specialist should have been consulted to give guidance as to how long to treat the infection. The standard of care for treating a staph aureus infection where there is a known source of infection requires 14 days of intravenous antibiotics. Where the source is not known, then four to six weeks of antibiotics is recommended. In this case, the infection, a resistant staph infection found in the patient's blood, could have originated from several sources. While such staph could have sprung from a source in the lung, this is by no means likely and the infection could have originated from another source. The standard of care required that Respondent contact an infectious disease specialist for an evaluation and/or that he treat Patient W.B.C.’s staphylococcus with a minimum of 10 to days of intravenous antibiotics. On or about April 11, 1997, Patient W.B.C., presented to the emergency room at LRMC complaining of congestion, shortness of breath, fever of 100.3° F, and a cough. The emergency room physician performed a physical exam which revealed vital signs of a temperature of 101.3° F, a pulse of 104, and a blood pressure of 90/54. A chest x-ray, blood work and a urine culture were ordered. Patient W.B.C. was then admitted on April 11, 1997, with a diagnosis of pneumonia, an old cerebrovascular accident and coronary artery disease. The ER physician started Patient W.B.C. on a plan of treatment which included intravenous antibiotics, Vancomycin, IV fluids, and blood cultures. A physical examination on the patient revealed a temperature of 101.3° F, a pulse of 104 and blood pressure of 91/53. The attending physician diagnosed him with probable sepsis with pneumonia. On April 12, 1997, the blood cultures came back positive for Staphylococcus aureus bacteremia. On April 15, 1997, Patient W.B.C. was afebrile (without fever) and his white blood cell count was 10.23, which is within the normal range of 4.0 to 11.0. The patient continued in this condition through April 18, 1997, despite suffering from sepsis. On April 18, 1997, Respondent approved Patient W.B.C. for transfer to another institution for consideration for urgent mitral valve replacement. On April 19, 1997, Patient W.B.C. arrested and was pronounced dead at 5:53 a.m. Petitioner’s expert, Carlos Sotolongo, M.D., is board- certified in internal medicine, cardiovascular disease and nuclear cardiology. As established by Dr. Sotolongo's testimony, Respondent practiced below the standard of care by failing to treat Patient W.B.C. with a sufficient number of days of intravenous antibiotics and by failing to consult an infectious disease specialist. According to Dr. Sotolongo, there is a difference in the way that an uncomplicated pneumonia is treated as opposed to a pneumonia complicated by bacteremia. The latter must be treated more aggressively. Based on the foregoing, Respondent violated Section 458.331(1)(t), by failing to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing, it is recommended that a Final Order be entered finding that Respondent violated Section 458.331(1)(t), and imposing a penalty which includes a formal reprimand, payment of an Administrative Fine in the amount of $5,000.00 within 180 days, and eight hours of Continuing Medical Education (CME) to be completed within the next 12 months dealing with the diagnosis and treatment of infections and/or risk management. DONE AND ENTERED this 1st day of October, 2003, in Tallahassee, Leon County, Florida. S DON W. DAVIS 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 1st day of October, 2003. COPIES FURNISHED: William M. Furlow, Esquire Katz, Kutter, Alderman, Bryant & Yon, P.A. Post Office Box 1877 Tallahassee, Florida 32302-1877 Kim M. Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
