The Issue The issues are whether Petitioner overpaid Medicaid reimbursements to Respondent for inpatient hospital services due to the lack of medical necessity for such services and, if so, the amount of the overpayment.
Findings Of Fact Respondent is a 226-bed community hospital in Sanford. It is an acute-care hospital with an emergency department. At all material times, Respondent has been an authorized Medicaid provider. For inpatient services, Respondent receives, under Medicaid, an all-inclusive per diem rate for all goods and services provided during a 24-hour period, less any third-party payments. Petitioner is the state agency responsible for the regulation of the Medicaid program in Florida. Petitioner is required to perform Medicaid audits of providers and to recover any overpayments. Pursuant to this authority, Petitioner conducted an audit of Respondent for the period from January 1, 2001, through March 31, 2002. Pursuant to its procedures, Petitioner duly informed Respondent of the audit, obtained from Respondent relevant medical and hospital records, issued a Provisional Agency Audit Report on January 24, 2006, obtained additional information from Respondent pertinent to the provisional findings, and issued a Final Agency Audit Report on October 19, 2006, which claimed a total overpayment of $286,357.54 based on Medicaid payments made to Respondent on behalf of 35 different recipients. (The report indicates two separate denials for each of four recipients, so 39 total transactions are listed.) The dispute in this case concerns the medical necessity of the inpatient hospitalization of each recipient. The Florida Medicaid Hospital Services Coverage and Limitations Handbook (Handbook) states that the purpose of the Medicaid program is "to provide medically necessary inpatient and outpatient services to recipients in the hospital." Handbook, page 1-1. This case involves paid claims for inpatient, not outpatient, services. The Handbook defines inpatient services as those services "rendered to recipients who are admitted to a hospital and are expected to stay at least 24 hours and occupy a bed, even though a bed is not actually utilized because the recipient is discharged or transferred to another hospital." Handbook, page 1-1. The Handbook provides that the day of admission is covered, but the day of discharge is not covered, unless it is also the day of admission. Handbook, page 2-22. The Handbook defines "grace days" as non-medically necessary days following the day of formal discharge when the recipient continues to occupy a hospital bed until an outside facility or residence can be found. These days are not reimbursable by Medicaid except for children under 21 years of age on "Department of Children and Families hold . . .." Medicaid will pay up to 48 hours of inpatient stay beyond the formal discharge day for these children while an alternative placement is located. The Handbook incorporates the limitation of medical necessity as follows: Medicaid reimburses for services that are determined medically necessary, do not duplicate another provider's service, and are: individualized, specific, consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the patient's needs; not experimental or investigational; reflective of the level of services that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available statewide; furnished in a manner not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or service medically necessary or a covered service. Note: See Appendix D, Glossary, in the Florida Medicaid Provider Reimbursement Handbook, UB-92, for the definition of medically necessary. Handbook, pages 2-1 to 2-2. The Florida Medicaid Provider Reimbursement Handbook, UB-92, Appendix D, defines "medically necessary" as follows: Means that the medical or allied care, goods, or services furnished or ordered must: Meet the following conditions: Be necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain; Be individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the patient's needs; Be consistent with generally accepted professional medical standards as determined by the Medicaid program, and not experimental or investigational; Be reflective of the level of service that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available; statewide; and Be furnished in a manner that is not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. "Medically necessary" or "medical necessity" for inpatient hospital services requires that those services furnished in a hospital on an inpatient basis could not, consistent with the provisions of appropriate medical care, be effectively furnished more economically on an outpatient basis or in an inpatient facility of a different type. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or services medically necessary or a medical necessity or a covered service. The Florida Medicaid Provider Reimbursement Handbook, UB-92, Appendix D, page D-10. E. A. was admitted on January 6, 2001. Petitioner does not contest the medical necessity of inpatient services to treat E. A.'s acute exacerbation of chronic bronchitis from January 6-8. The parties' dispute concerns the medical necessity of the remaining ten days of E. A.'s hospitalization. (All calculations of duration of hospitalizations omit the day of discharge, pursuant to the above-cited provision from the Handbook. In this case, for instance, E. A. was discharged on January 19.) E. A., a 60-year-old male, presented to the emergency department with shortness of breath and a history of chronic obstructive pulmonary disease (COPD), emphysema, and hypertension. He had been unable to eat for the preceding four days due to respiratory distress. At the time of his admission, E. A. had been living for a short while with his sister, who was suffering from cancer. His relevant history included a shotgun wound to the left lung 30 years earlier. Respondent states in its proposed recommended order that E. A.'s chest X-rays showed acute infiltrate demonstrating pneumonia, although the discharge summary reveals that chest X-rays fail to reveal this condition, but acknowledged that sputum grain stains revealed a polymicrobial infection. More to the point, the X-ray reports dated January 6 and 8 note: "no focal infiltrate." However, the discharge summary described E. A.'s prognosis as poor because he was in "end-stage lung disease." In the emergency department, after treatment with bronchodilators, E. A.'s oxygen saturation rate was only 87 percent--not 94-100 percent, as mistakenly stated by Petitioner's expert, Dr. Ellen Silkes, an otolaryngologist whose practice is largely limited to outpatients. This low rate of oxygen saturation evidences hypoxia. E. A.'s arterial blood gases bore a pH of 7.28, evidencing, on the facts of this case respiratory acidosis, which results from excessive retained carbon dioxide due to poor lung function. E. A. was started on Albuterol and Atrovent by nebulizer at four-hour intervals, as well as a corticosteroid intravenously every six hours to relieve the swelling in the lungs. He received oxygen by nasal cannula. On January 10, the physician's notes state that E. A. still suffered from "severe COPD" secondary to smoking with bronchospasms. According to the notes, the first day that E. A. showed any improvement was January 12. On January 14 and 16, E. A. was still retaining excessive carbon dioxide and remained hypoxic, but showed some improvement by January 16 in terms of arterial blood gases. The physician's note for January 17 states that E. A. could be discharged as soon as arrangements for home health care were completed. E. A.'s hospitalization was medically necessary from January 6-17. His hospitalization after January 17 was not medically necessary. Petitioner improperly denied January 9-16, given that the day of discharge is excluded. Thus, for E. A., Petitioner should have denied two days, not all ten days. A. A. was admitted on June 19, 2001. Petitioner does not contest the medical necessity of inpatient services to treat A. A.'s gastrointestinal bleeding from June 19-20. The parties' dispute concerns the medical necessity of the remaining 12 days of A. A.'s hospitalization. (Some of Petitioner's calculations are incorrect. For instance, in this case, Petitioner does not deny July 2-5, even though, undoubtedly, its position as to the lack of medical necessity as to the earlier dates would mandate the same position as to the later dates. This recommended order does not disturb Petitioner's implicit acceptance of the medical necessity of any dates, even when it appears to be in error.) A. A., a 51-year-old male, presented to the emergency department with abdominal pain, diarrhea, and black tarry stools. His recent history included bloody vomit and a diagnosis, a few months earlier, of a pulmonary embolism. A. A. had discontinued taking Coumadin, a blood thinner, due to nosebleeds. A. A. had been diagnosed with AIDS in 1998 and had lost 30 pounds in one month. At admission, A. A.'s hemoglobin and hematocrit levels were critically low at 5.1 and 15.5, respectively, and remained critically low the following day when, after A. A. received transfusions of two units of packed red blood cells, his hemoglobin and hematocrit levels were only 6.8 and 20.0, respectively. Dr. Silkes denied the hospitalization after June 20 because an upper gastrointestinal endoscopy revealed, on June 19, no acute bleeding, and a bleeding scan the following day was negative. However, according to the physician's notes, A. A. was continuing to experience diarrhea on June 20, even though he was starting to feel better. The course of treatment of A. A. was complicated by his recent history of pulmonary embolism and his inability to report an accurate history. By June 21, A. A.'s severe anemia had been corrected, but he was diagnosed with candida, an opportunistic fungal infection common in AIDS patients. This diagnosis would explain the vomiting of blood. Generally, the treatment dilemma posed by A. A. was that efforts to increase his clotting time to stop the bleeding raised the risk of pulmonary embolism. The physicians debated whether to install a Greenfield filter to stop the passage of a blood clot. The filter is introduced under X-ray control through the femoral vein into the inferior vena cava, where it is anchored, so that it allows the passage of blood, but not the passage of a blood clot. But the Greenfield filter is contraindicated in the presence of A. A.'s fever of 101 degrees and elevated white blood counts. Physicians introduced Coumadin to minimize the risk of clots, but A. A.'s low platelet count required the discontinuation of Coumadin on June 30. A. A.'s International Normalization Ratio (INR) was 4.2, which is well above the range of 2.0-3.0 and thus indicative of the fact that A. A.'s blood was taking too long to clot. The standard of care in 2001 precluded safe outpatient management of a complicated patient such as A. A., given his twin risks of pulmonary embolism and bleeding, either of which could result in his death. A. A.'s Coumadin could not safely have been adjusted on an outpatient basis. The physicians restarted the Coumadin on June 24 and doubled its dosage the following day. As they were working on adjusting the blood thinner, though, A. A. continued to suffer nightly fevers of 103 degrees, and the physicians needed to monitor him closely for the next week for this reason too. On June 28, A. A. reported that he was feeling better, but the physicians needed to monitor him for a recent reduction in his Coumadin dosage. A. A. was reported as "alert and comfortable" on July 2. A. A.'s hospitalization was medically necessary from June 19 through at least July 2. Petitioner improperly denied all ten days of this hospitalization. T. B. was admitted on May 15, 2001. Petitioner does not contest the medical necessity of inpatient services to treat T. B.'s esophageal cancer and tuberculosis from May 15-17 and The parties' dispute concerns the medical necessity of the ten days that Dr. Silkes denied of the remaining 14 days of T. B.'s hospitalization. (It is unclear why Petitioner denied only ten days when Dr. Silkes denied May 18-20 and May 22-June 1--a total of 14 days, or 13 days exclusive of the day of discharge. But, as noted above, in cases such as this, the recommended order will consider only whether up to ten days within this period are allowable as medically necessary.) T. B., a 47-year-old male, presented to the emergency department with difficulty swallowing. He had visited a physician in February 2001 with the same complaint, and the physician had recommended an upper gastrointestinal series. Due to financial constraints, T. B. did not undergo this procedure until late April, when he was found to have a high-grade obstruction consistent with a tumor. T. B.'s recent history included the loss of 25 pounds. An endoscopy with biopsy performed on May 16 revealed a high-grade carcinoma of the esophagus. The physician planned to commence preoperative chemotherapy and radiation therapy to shrink the lesion, but, based on sputum collected on May 18, it was discovered that T. B. had mycobacterium tuberculosis. Physicians had suspected the tuberculosis from the time of admission when they placed T. B. in a negative airflow isolation room. Treatment of the tuberculosis necessarily preceded the preoperative chemotherapy recommended for T. B.'s carcinoma. The sputum sample revealed rare acid-fast bacilli, for which the standard of care in 2001 typically required two to three weeks of treatment before isolation precautions could be discontinued. T. B. remained in isolation at least through May 31. In addition, T. B. suffered significant pain from the carcinoma. By May 23, he was on patient-controlled analgesia in the form of a morphine pump, which is not available outside of an acute-care hospital. T. B.'s hospitalization was medically necessary from May 15 through at least June 1. Petitioner improperly denied all ten days of this hospitalization that it denied. R. B. was admitted on December 3, 2001. Petitioner does not contest the medical necessity of inpatient services to treat R. B.'s respiratory failure from December 3, 2001, to January 2, 2002, and January 8, 2002. Based on Petitioner's prehearing stipulation, the dispute concerns only seven days' hospitalization. R. B., a 59-year-old female, presented to the emergency department with acute respiratory distress and respiratory failure. She was immediately intubated. Her family insisted upon aggressive treatment of, among other things, her bilateral pneumonia caused by a virulent staph infection. R. B. required a tracheotomy on December 20 due to the difficulty in weaning her from the ventilator. She required the placement of a percutaneous endoscopic gastrostomy (PEG) tube on January 1. The discharge summary describes R. B. as "very frail and fragile" and her hospitalization as "very prolonged and complicated." On December 23, when R. B. was finally weaned from the ventilator, her family agreed to a do-not-resuscitate (DNR) code for her. The dispute arises from an incident on January 3 when R. B. fell when trying to get out of bed. Her mental status deteriorated, probably due to malignant disease. Physicians ruled out sepsis in the bloodstream, but X-rays revealed multiple nodules in the lung and liver. On January 8, a CT- guided lung biopsy of one of the nodules confirmed malignant disease. Two days later, the physician stated that a consultation with hospice was indicated. Upon the agreement of the family, R. B. was discharged to her home under hospice care on January 12. Dr. Silkes is substantially correct in her opinion. The diagnostic work after January 2 only supported the poor prognosis that had become obvious to R. B.'s family ten days earlier and certainly was not palliative in nature. R. B.'s hospitalization after January 2, 2002, was not medically necessary--except for January 8, which Dr. Silkes initially conceded, and an additional two days, which Petitioner conceded in its prehearing stipulation. Petitioner properly denied seven days of this hospitalization. J. B. was admitted on January 5, 2002. Petitioner does not contest a 23-hour observation on January 5, but this would generate a reimbursement considerably smaller than that sought by Respondent for inpatient services for that day, so Petitioner has essentially denied the entire hospitalization, which consists of 16 days. J. B., a 59-year-old male, presented to the emergency department with shortness of breath and atrial fibrillation with fast ventricular rate. He had been diabetic for 25 years. He had been laid off from construction work in August 2001, and had arthritic knees which prevented his return to work. Since losing his job, J. B. had been feeling poorly and had lost 20 pounds. J. B.'s pulse at the time of his arrival was 165, and it dropped to 105 within his first six hours at the hospital. J. B.'s relevant history included congestive heart failure, edema of the extremities, and nocturnal dyspnea. A chest X-ray on the day of admission revealed a dense mass in the left lobe. Physicians started a calcium channel blocker to regulate J. B.'s rapid heart beat and a diuretic to eliminate his excess fluids and swelling. J. B. was feeling much better by January 7, as the physicians had controlled his rapid heart beat. On that day, J. B. underwent a stress test, which was negative. However, a CT scan performed on January 8 and reported the following day revealed a left hilum mass that proved to be advanced carcinoma. The physicians decided that J. B. needed a bronchoscopy to biopsy the lung mass and a thoracentesis, in which a needle is inserted between the ribs to extract fluid for the purpose of determining the fluid's source. However, J. B.'s atrial fibrillation complicated their plans. On January 8, J. B. remained in atrial fibrillation, and the physicians were considering starting him on Coumadin because patients with atrial fibrillation are at high risk of clotting due to the poor expulsion of blood into the ventricle. Introduction of this blood-thinning agent before other invasive procedures requires first that the physicians stabilize the patient. This dilemma delayed the introduction of the blood- thinning agent and prevented treating J. B. as an outpatient. Once stabilized on Coumadin, J. B. underwent the two diagnostic procedures on January 11. They revealed that he was suffering from stage IV squamous cell carcinoma, according to a physician's report dictated on January 14 and transcribed the following day. The physician ordered additional CT scans to determine the extent of the metastatic disease before deciding on a course of treatment. A whole body bone scan was performed on January 15 and was essentially negative. However, the carcinoma had metastasized to the left hilum and, by report dated January 15, a physician noted that J. B. would not benefit from surgery, chemotherapy, or radiation, although palliative radiation could offer him some relief. An IV port for chemotherapy (not radiation) was placed on January 16--not January 6, as noted by Dr. Silkes in her report. Coumadin had been discontinued in advance of the procedure and resumed on the day of the procedure, but required adjustment for the next several days, as J. B.'s INR was too low, indicative of excessive clotting. Although the administration of the chemotherapy through the IV port could have been done on an outpatient basis, J. B. was comfortable at all times after January 15, and with no effective treatment possible, his hospitalization remained medically necessary until the physicians were able to adjust his Coumadin so that his INR reached the normal range. J. B.'s hospitalization was medically necessary from January 5 through January 22, on which date he was discharged. Petitioner improperly denied the 16 days of inpatient services. N. C. was admitted on February 8, 2002. Petitioner does not contest the medical necessity of inpatient services to treat N. C.'s intracranial hemorrhage from February 8-10. The parties' dispute concerns the medical necessity of the remaining 21 days of N. C.'s hospitalization. N. C., a 40-year-old female, presented to the emergency department with a complaint of passing out and no significant medical history. N. C. was a single mother of a developmentally disabled child. Her father resided in a nursing home and suffered from dementia, so her siblings were her decisionmakers concerning care. At admission, N. C. was already in a vegetative state, suffering from a massive intracranial hemorrhage. Her blood pressure was 213/107. She was immediately intubated and given Mannitol to reduce intracranial pressure and Dilantin to prevent seizures. On February 8, a neurologist evaluated N. C. and found her a poor candidate for surgery to evacuate the intracranial hematoma due to the likelihood of extensive consequent neurological deficits. The neurologist discussed the possibilities and the "extremely poor" prognosis with the siblings, who decided not to pursue surgery and instead allow N. C. to be "managed medically." The physicians asked the siblings to consider a DNR code for N. C. N. C. made no meaningful progress in the following days. Respondent was unable to contact her siblings until February 19, and they asked for two days within which to make the decision whether to place N. C. on a DNR code. On February 22, they decided to place N. C. on a DNR code and withdraw the ventilator. Three days later, the physician discussed with the siblings the possibility of placement in a nursing home. Three days after this discussion, the siblings agreed on inpatient hospice care for N. C. On March 4, IV fluids and medications and the nasogastric feeding tube were withdrawn, and N. C. was transferred to a nursing home under hospice care. N. C.'s hospitalization was medically necessary through February 22 because a nursing home cannot accept a patient on a ventilator, N. C.'s course following the stroke could reasonably be observed for a couple of weeks to determine if improvement--however unlikely--might take place, and the siblings reasonably required this long to make this difficult decision. From February 23 through discharge, the inpatient services provided N. C. were no longer medically necessary, so Petitioner properly denied nine days of the 21 days that it denied for this recipient. N. Ch. was admitted on May 23, 2001. Petitioner does not contest the medical necessity of inpatient services to treat N. Ch.'s cellulitus and osteomyelitis from May 23 to June 24. The parties' dispute concerns the medical necessity of the remaining 46 days of N. Ch.'s hospitalization. N. Ch., a 38-year-old male, presented to the emergency department with wounds to both legs and loss of feeling in both feet and a history of fractures to both tibias 20 years ago followed by osteomyelitis four years ago. Despite considerable hospital treatment to both legs, consisting of antibiotics, hyperbaric oxygen, debridement, and skin grafts, drainage of the wounds persisted. Four grainy wounds on both legs penetrated to the bone, and N. Ch. had suffered some bony damage from the persistence of these infected wounds. A physician performed a surgical debridement of the wounds on May 26, and a vacuum- assisted closure device was applied to the wound on the following day. This device produces negative air pressure to stimulate a chemical change in the tissues to enhance the migration of new blood vessels and granulation tissue over the area of the wound. The pump was changed often. On June 22, N. Ch. underwent a second debridement and a pump was reapplied to the wounds on June 24. The issue in this case involves the use of hyperbaric oxygen treatment on an inpatient basis. On June 7, a physician reasonably recommended 20, 90-minute hyperbaric oxygen treatments. The treatments, which accelerate wound healing, began the next day. Dr. Silkes correctly finds no medical necessity after N. Ch. became stable after the second debridement. Although he later suffered some fever, apparently from his reaction to an antibiotic, and gastroesophagael reflux, as well as some adverse reactions to IV and peripherally inserted central catheter lines, N. Ch. could have been managed as an outpatient after June 24. Nothing suggests that the vacuum-`assisted closure device requires hospitalization, and hyperbaric oxygen treatment clearly does not require hospitalization. Respondent contends that inpatient services remained medically necessary after June 24 because Medicaid would not pay for hyperbaric oxygen treatment on an outpatient basis. Medical necessity is driven by medical, not legal, considerations. If the sole reason for hospitalization is to obtain a medically necessary good or service that Respondent has restricted to the inpatient setting, then the provider community improperly circumvents Petitioner's restriction. If there is no other reason to continue to hospitalize a recipient, such as N. Ch., the decision to do so in order to obtain for him a concededly medically necessary service--that does not otherwise require hospitalization--is unwarranted. Petitioner properly denied the 46 days of inpatient services for N. Ch. after June 24. J. C. was admitted on February 24, 2002. Petitioner does not contest the medical necessity of inpatient services to treat J. C.'s coronary artery disease and lymphoma on February 24 and March 3-8. In its proposed recommended order, Respondent does not contest Petitioner's denial of the "last two days," which apparently are March 9-10. The parties' dispute concerns the medical necessity of the remaining six days of hospitalization from February 25 through March 2. J. C., a 61-year-old female, presented to the emergency department with worsening chest pain over the past two weeks and a history of coronary artery disease. She also had an undiagnosed mass on her neck. She had previously failed outpatient treatment and was admitted to the hospital. Two weeks earlier, J. C. was to have had an outpatient biopsy of the neck mass, but the anesthesiologist declined to administer anesthesia until her unstable angina was addressed. J. C. went to her primary care physician, who referred her to a cardiologist, but, prior to seeing him, J. C. went to the emergency department. On February 25, the physician's notes indicate that J. C. was stable and without chest pain. The cardiologist performed a cardiac catheterization on February 26 and found 100 percent blockage of the left anterior descending artery, 80 percent blockage of the proximal circumflex, and other narrowings that were not amenable to angioplasty and stenting, so he recommended coronary artery bypass grafting. Heart surgery could not proceed until physicians learned the nature of the neck mass. A biopsy was performed on February 28, which revealed B-cell malignant lymphoma. The oncologist preferred to commence chemotherapy after the bypass operation, so this was performed on March 3. J. C. was extubated on March 4, but developed acute respiratory distress on March 5 and required a transfusion the following day. However, Dr. Silkes is correct in finding the hospitalization from February 25 through March 2 medically unnecessary. The procedures performed during this period could have been done on an outpatient basis. The record does not support Respondent's argument that her unstable angina required inpatient management. Petitioner properly denied these six days of inpatient services. R. LaB. was admitted on April 2, 2001. The parties' dispute concerns the medical necessity of the last day of inpatient service on April 12. This is the first case considered in this recommended order handled by Dr. Alan Yesner, an internist whose practice is more evenly divided between inpatients and outpatients than is Dr. Silkes' practice. R. LaB., a 47-year-old female, presented to the emergency department with abdominal pain of two days' duration and a history of COPD, hypertension, and diabetes. She was rushed to abdominal surgery to reduce an incarcerated hernia. The surgery was long. R. LaB. suffered respiratory failure and required intubation. Dr. Yesner is correct in opining that R. LaB.'s hospitalization after April 11 was not medical necessary. She was stable and on appropriate medication, so Petitioner properly denied one day of inpatient service for R. LaB. J. L. was admitted on June 12, 2001. The parties' dispute concerns the medical necessity of the seven days of inpatient services. J. L., a 47-year-old male, presented to the emergency department with complaints of a gradual increase of abdominal girth and was found to have blood in his stool. Lab work indicated an elevated INR, elevated bilirubin, and bacteria in his urine. The physician concluded that J. L. suffered from primary biliary cirrhosis, for which he had been treated since at least 1998. J. L. admitted that he had become noncompliant with his medication after a divorce. A CT scan revealed a probable stone obstructing the right ureter, causing urine to back up and flood the right kidney. A successful laser lithotripsy was performed on June 17 with the complete fragmentation of the stone and the installation of a stent, which would facilitate drainage, to be removed a few days later. J. L. tolerated the procedure well, and on the next day he reported feeling better without any pain in his flank. Dr. Yesner notes the "late schedule" of the lithotripsy, but Respondent did not have a lithotripter in 2001 and had to schedule it for use at the hospital. The hospitalization was medically necessary through June 17 due to the pain, advanced kidney disease, and potential kidney problems presented by the blockage, prior to its surgical fragmentation. Petitioner should have denied two days, not seven days. C. M. was admitted on April 2, 2001. Petitioner does not contest the medical necessity of admission for 23-hour observation only on April 2 for end-stage sarcoidosis, pneumonia, and gastrointestinal bleeding. The parties' dispute concerns the medical necessity of the remaining 31 days of C. M.'s hospitalization, which concluded with her death. C. M., a 55-year-old female, presented to the emergency department with shortness of breath and weakness. She is a Jehovah's Witness, so she declines blood transfusions on religious grounds. By April 4, C. M.'s blood gases, although not within normal ranges, were out of critical ranges. C. M. suffered respiratory failure and required intubation on April 16. Her hemoglobin gradually dropped after this, but treatment was limited to iron and vitamins due to the refusal of the patient to accept a blood transfusion. This treatment was unsuccessful. The family supported C. M.'s decision not to accept a blood transfusion, but insisted on full, aggressive treatment, including CPR. C. M. went into cardiac arrest on May 3 and CPR failed to revive her. Dr. Silkes states that Respondent should have arranged for hospice care during the first day of hospitalization. C. M. was not then on a ventilator, so a hospice would not have objected to taking C. M. on that ground, but her respiration was critically impaired for the first three days of her hospitalization and her prognosis was not such as to render hospital care medically unnecessary. It was medically necessary to stabilize C. M.'s respiration during these first three days, but her hemoglobin issues could have been addressed by home health care for the next 11 days. The medical necessity of inpatient services resumes, though, after C. M.'s respiratory failure of April 16 and continues to the end of her hospitalization. The first three days of inpatient services were medically necessary, the next 11 days of inpatient services were not medically necessary, and the last 17 days of inpatient services were medically necessary, so Petitioner should have denied 11 days, not 31 days. M. M. was admitted on March 3, 2001. Petitioner does not contest the medical necessity of inpatient services to treat acute asthmatic bronchitis with a history of coronary artery bypass graft, asthma, sarcoidosis of the lung, and diabetes from March 3-12, which Petitioner later extended to March 13. The parties' dispute concerns the medical necessity of the remaining three days of M. M.'s hospitalization, which Respondent's expert frankly conceded was difficult to justify. As Dr. Yesner noted, M. M. was stabilized on oral medication by March 11, and he allowed a couple of additional days to monitor her. M. M. experienced hypoglycemia on March 16, but this is a condition that, according to Dr. Yesner, is not unusual with the Prednisone that M. M. was taking, and hypoglycemia is typically managed on an outpatient basis. Petitioner properly denied the last three days of M. M.'s hospitalization. J. P. S. was admitted on January 4, 2001. Petitioner does not contest the medical necessity of inpatient services to treat J. P. S.'s obstruction of the common bile duct. The parties' dispute concerns the medical necessity of the last three days of his hospitalization. J. P. S., a 54-year-old male, presented to the emergency department with severe jaundice and a history of diabetes, congestive heart failure, and triple coronary artery bypass graft performed in 1997, although he displayed no significant cardiac abnormalities during this hospitalization. During the initial examination, J. P. S. went into respiratory arrest and required intubation. The gastroenterologist found J. P. S. ready for discharge, from a gastroenterological perspective, on January 13. but J. P. S. immediately developed COPD symptoms, including shortness of breath and edema. According to the physician notes, J. P. S. was sufficiently stable for discharge on January 15, but a note for the next day says to hold the discharge pending cardiac evaluation. Respondent discharged J. P. S. three days later, after physicians could monitor the level of Digoxin to ensure that J. P. S. was safe for discharge. P. S.'s entire hospitalization was medically necessary. Petitioner improperly denied the last three days of inpatient services. J. P. was admitted on December 8, 2001. Petitioner does not contest the medical necessity of services to treat J. P.'s fever from December 8-12. The parties' dispute concerns the medical necessity of the remaining 14 days of J. P.'s hospitalization. J. P., a 27-year-old male, presented to the emergency department with high-grade fevers and severe headaches and a history of AIDS. Dr. Silkes approved the treatment of the fever until it ended on December 12. The fever was likely caused by J. P.'s toxoplasmosis of the central nervous system. This is an opportunistic condition not unusual in immunocompromised patients. Candida fungal infection likely caused J. P.'s complaints of pain on swallowing, as this too is an opportunistic condition. Additionally, a blood culture revealed a staph infection. Through December 18, J. P. was continuing to experience fevers of up to 101 degrees. At the same time, it was necessary to address the toxoplasmosis before it extended to other organs. This required the sequential administration of IV antibiotics and careful, continual monitoring of the patient for his clinical response to treatment. On December 20, J. P. underwent a bone marrow biopsy to rule out the extension of toxoplasmosis in the bone marrow or the presence of tuberculosis. This test was negative, which was a precondition for discharge. The pathology report was "received" on December 21, but not "printed" until December 27. However, J. P. did not complete his IV administration of Doxycycline until December 23, when the medical necessity for his inpatient services ended. Petitioner should have denied three days, not 14 days. W. P. was admitted on June 18, 2001. Dr. Silkes would allow only a 23-hour observation on the day of admission for the treatment of lung cancer and tuberculosis. The parties' dispute concerns the medical necessity of 13 days of his hospitalization from June 18 through July 1 (even though he was not discharged until July 13). W. P., a 59-year-old male, presented to the emergency department with severe coughing up of blood and a recent loss of 40 pounds. A chest X-ray at admission revealed a large mass in the upper left lobe of the lungs. Lab work suggestive of anemia correlated with a malignancy as its source. Sputum to test for acid fast bacillus was taken, and a consult was immediately arranged with a pulmonary specialist to consider a bronchoscopy and to take a biopsy. A CT scan of the chest on June 18 revealed abnormal soft tissue density filling the right upper lobe, two tumors, and numerous nodes. The bronchoscopy on June 19 revealed 80 percent obstruction of the right main bronchus secondary to an endobronchial lesion and 100 percent obstruction of the right upper lobe. A biopsy of the right mainstem bronchus revealed a squamous cell carcinoma. A physician noted in his consultation report that W. P. was to complete his metastatic survey on the day of the report--June 22--after which they would discuss palliative treatment. The report states that the patient understands that he will unlikely live more than six months. Subsequently, acid fast bacillus, which had originally not been detected, was found, so W. P. was placed in isolation on June 26. He had been experiencing elevated white blood counts and fevers. He was placed on antituberculosis treatment, which, as noted above, typically takes two or three weeks until the patient can be removed from isolation. July 10 was W. P.'s first day without fever. On this date, Respondent sent his records to the Health Department to facilitate a transfer to a tuberculosis hospital. He was discharged on July 13. W. P.'s entire hospitalization was medically necessary. Petitioner should not have denied any of the 13 days that it denied. M. Pr. was admitted on December 18, 2001. Petitioner does not contest the medical necessity of inpatient services to treat M. Pr.'s coronary artery disease from December 18-27. The parties' dispute concerns the medical necessity of the remaining seven days of M. Pr.'s hospitalization. M. Pr., a 58-year-old male, presented to the emergency department with a recent cardiovascular accident while out of state. A cardiac catheterization revealed severe triple vessel coronary artery disease. On December 19, M. Pr. underwent a four-vessel bypass. Post-operatively, however, M. Pr. fell while on the commode. The dispute in this case arises due to the unavailability of rehabilitation facilities that would take M. Pr. after his fall. He was suitable for discharge on December 28, but no facility could be found to receive him. These are "grace days," as noted in the Handbook and are available, on a limited basis, for persons under 21 years of age, but, by negative implication, are unavailable for adults. Thus, medical necessity dictated that Respondent discharge M. Pr. on December 27, so the inpatient services are not reimbursable after December 28, given that the day of discharge is not allowable. Dr. Silkes' determination was correct in this case. Petitioner properly denied seven days' inpatient services for M. Pr. A. R. was admitted on December 30, 2001. Petitioner has denied the entire 14 days of A. R.'s hospitalization, although Dr. Silkes approved one day's inpatient services, on the day of admission, for the treatment of ovarian cancer. A. R., a 63-year-old female, presented to the emergency department with vomiting on the day of admission, progressive abdominal distension, anorexia, weight loss over the past month, and a 15-year history of bronchial asthma. A CT scan of A. R.'s thorax at the time of admission revealed a large collection of fluid in the abdominal cavity. At this time, a physician removed 4.5 liters of fluid from the cavity, and A. R., not surprisingly, began to feel much better. A report on January 3--delayed probably due to the holidays-- indicated the presence of scattered malignant cells in the withdrawn fluid compatible with carcinoma. Metastatic ovarian cancer was subsequently confirmed. A. R.'s case was complicated by the withdrawal of this large volume of fluids, which required continual monitoring of her electrolytes, and the sudden exacerbation of her dementia on January 2, which would impede outpatient services, as well as the initiation of chemotherapy. The dementia, which had been progressive for the past six months, was likely a reaction to the carcinoma. By January 11, a physician recommended hospice placement given A. R.'s incurable tumor. A. R.'s daughter agreed on this day to hospice placement. This is the day that medical necessity for inpatient services ended. Petitioners should have denied three days, not 14 days. The remaining days were medically necessary. E. S. was admitted on May 4, 2001. Petitioner does not contest the medical necessity of inpatient services to treat E. S.'s pancreatitis and multisystem failure from May 4-23. The parties' dispute concerns the medical necessity of the remaining 24 days of her hospitalization, which ended with her death. E. S., a 64-year-old female, presented to the emergency department with nausea and abdominal pain and a history of hypertension and abuse of alcohol and tobacco. She was found to have elevated pancreatic enzymes. On May 8, E. S. underwent a laparoscopic removal of her gallbladder, which she tolerated well, but soon afterwards suffered respiratory failure. E. S. was then placed on a ventilator. Problems with malnourishment and then kidney failure precluded a successful weaning her off the ventilator. On May 23, the family agreed to a DNR code. May 23 marks the last day that Dr. Silkes found that E. S.'s hospitalization was medically necessary. Care after this date was entirely supportive and not medically necessary; however, no hospice or skilled nursing facility would take E. S. because she could not be weaned off the ventilator. The unavailability of an alternative, less costly setting does not automatically render the inpatient care of a recipient medically necessary. The circumstances dictate whether inpatient services to such a patient are medically necessary. Here, it is impossible to find that services after May 23 were medically necessary. Dr. Silkes was correct in her opinion. Petitioner properly denied all 24 days of inpatient services for E. S. D. S. was admitted on March 24, 2001. Petitioner does not contest the medical necessity of inpatient services to treat D. S.'s osteomyelitis of the right foot from March 24-25 and March 30-April 10. (Originally, Dr. Silkes allowed only March 24-25 and March 30-April 6, but, on February 7, 2007, she revised her opinion to allow the additional four days to April 10.) In its prehearing statement, Petitioner conceded that only three of the original ten denied days remained at issue, as it was agreeing that an additional seven days were medically necessary. The parties' dispute concerns the medical necessity of the remaining three days, although it is not clear what three days Petitioner is contesting. D. S., a 57-year-old female, presented at the emergency department with a "hole in the right foot" and a history of diabetes. She dropped a can of juice on her foot on January 1, and the foot had become progressively infected since that time. On the day of admission, she underwent surgery for the removal of fourth and fifth metatarsal bones and toes of the right foot. She did not heal properly and required followup surgery on April 7 to trim some of the necrotic flap, as the physicians considered the possibility of a below-knee amputation. On April 13, the surgeon probed the wound, found no hidden pockets, and discharged D. S. Regardless what three days that Petitioner continues to find were not medically necessary, the entire hospitalization was medically necessary. J. W. was admitted on August 20, 2001. Petitioner does not contest the medical necessity of inpatient services to treat J. W.'s multiple organ failure from August 20 to September 14. The parties' dispute concerns the medical necessity of the remaining two days of J. W.'s hospitalization, at which time he died. J. W., a 48-year-old male, presented to the emergency department with a two or three-day history of progressive congestive heart failure with pulmonary edema, atypical chest pain, and increasing abdominal girth. His history included nonischemic cardiomyopathy with minimal coronary artery disease, chronic alcohol abuse, pulmonary hypertension, chronic atrial fibrillation requiring anticoagulation therapy, hepatitis B and C, chronic renal insufficiency, and chronic congestive heart failure with multiple hospitalizations. On admission, his INR was 6.6, indicative of very slow clotting. Despite the care of numerous consultants, J. W. suffered increased respiratory failure on September 5, at which time he was intubated. He received a Greenfield filter on September 7 to prevent further pulmonary clots. Starting September 10, and continuing everyday thereafter, J. W. required dialysis due to renal failure. J. W. was on total parenteral feeding as of September 14. The family, whose availability had been a problem, agreed to a DNR code on September 17. Respondent claims in its proposed recommended order that a DNR code is a precondition to hospice care, but no competent evidence establishes this fact. Dr. Silkes and Petitioner properly denied the last two days because they were not medically necessary. M. W. was admitted on June 10, 2001. Petitioner does not contest the medical necessity of inpatient services to treat M. W.'s ventricular fibrillation and complications from June 10- The parties' dispute concerns the medical necessity of the remaining seven days of M. W.'s hospitalization. M. W., a 31-year-old male, presented to the emergency department with cardiopulmonary arrest after his wife found him slumped on the sofa, seizing. On arrival, he was found to be in ventricular fibrillation, and he was intubated. Physicians restored a normal rhythm, but M. W. suffered a seizure in the emergency department, so he was given large doses of Dilantin. M. W. had suffered brain damage from cerebral anoxia. M. W. was extubated on June 13, and his breathing remained stable. He remained in normal sinus rhythm. M. W. began to receive Librium on June 13 to sedate him. The cardiologist proposed a cardiac catheterization, but M. W. refused. An EKG on June 15 found a conduction defect in M. W.'s heart that was suggestive of Wolff Parkinson White syndrome. The cardiologist then determined, on June 16, that M. W. required an electrophysiology study to rule out Wolff Parkinson White syndrome. In 2001, Respondent lacked the equipment to perform this study, for which M. W. remained too confused to participate on June 18 anyhow. Physicians continued to monitor M. W.'s cardiac rhythm, and, when a bed opened at Florida Hospital, Orlando, which had the necessary equipment, Respondent promptly transferred M. W. on June 22. During the transfer, the cardiac monitor continued to check M. W.'s rhythm due to the risk of another cardiac incident until the underlying cardiac abnormality was assessed and treated. Petitioner improperly denied the final seven days of M. W.'s hospitalization. M. W. had suffered a serious cardiac event. Physicians had not yet ruled out all possible reasons for the event and needed to address a promising possibility of Wolff Parkinson White syndrome, so M. W. remained at risk for another event. He was confused from the brain damage. All of these factors militate in favor of finding that the remaining seven days of inpatient services were medically necessary. E. A. $1666.62 R. B. $5703.18 N. C. $7332.66 N. Ch. $38,332.26 J. C. $4888.44 R. LaB. $833.31 J. L. $1666.62 C. M. $9166.41 M. M. $2499.93 The total overpayment is $104,309.97, which breaks down as follows: J. P. $2444.22 M. Pr. $5703.18 A. R. $2444.22 E. S. $19,999.44 J. S. $1629.48
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding overpayments totaling $104,309.97 during the audit period and requiring that Respondent repay this amount, imposing an administrative fine of $1000, requiring Respondent to prepare a corrective action plan, and reserving jurisdiction to remand the case to the Division of Administrative Hearing for a determination of Petitioner's entitlement to statutory costs, if any. DONE AND ENTERED this 6th day of June, 2007, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 6th day of June, 2007. COPIES FURNISHED: Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Craig H. Smith, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Dr. Andrew C. Agwunobi, Secretary Agency for Health Care Administration Fort Knox Building 3116 2727 Mahan Drive Tallahassee, Florida 32308 Richard M. Ellis, Esquire Rutledge, Ecenia, Purnell & Hoffman, P.A. 215 South Monroe Street, Suite 420 Post Office Box 551 Tallahassee, Florida 32304-0551 William Blocker, Esquire Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive, Building 3 Tallahassee, Florida 32308 Daniel Lake, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III, Mail Stop 3 Tallahassee, Florida 32308 Tracy Cooper, Esquire Agency for Health Care Administration Fort Knox Building III, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308
The Issue The issue in this case is whether Petitioner's license should be classified as conditional, pursuant to Section 400.23(8)(b), Florida Statutes (1999), and Florida Administrative Code Rule 59A-4.1288. (All chapter and section references are to Florida Statutes (1999) unless otherwise stated. Unless otherwise stated, all references to rules are to the Florida Administrative Code in effect on the date of this Recommended Order).
Findings Of Fact Respondent is the state agency responsible for evaluating nursing homes in Florida pursuant to Section 400.23(8). Petitioner is a licensed nursing home located in Titusville, Florida (the "facility"). Chapter 400 originally required Respondent to conduct a survey of each nursing home in Florida every 12 months. Each survey was commonly referred to as an annual survey. The legislature subsequently changed the survey interval to every 15 months, but each survey is still referred to as an annual survey. Respondent conducted an annual survey of the facility on November 17 through 19, 1999. The survey report is identified in the record as the "2567 Report." The parties agree that the 2567 Report is the charging document. The 2567 Report expressly determined that Petitioner failed to ensure that resident number four (the "resident") did not develop pressure sores on September 16, 1999, and that Petitioner failed to ensure that the resident received the necessary treatment and services to prevent pressure sores from developing. The parties stipulated that no other deficiency is at issue in this proceeding. The resident had developed pressure sores on June 18, 1999, but those sores had healed before September 16, 1999, and are not at issue in this proceeding. The 2567 Report determined that the alleged deficiency violates 42 Code of Federal Regulations ("CFR") Section 483.25(c). Rule 59A-4.1288 applies relevant federal regulations to Florida nursing homes. The 2567 Report identifies the standard of care at issue as Tag F314. Based on the Tag 314, Respondent issued Petitioner a nursing home operating license rated as "Conditional" for the period November 19, 1999, through December 23, 1999. The conditional license decreased the license rating for Petitioner from "Standard" to "Conditional" within the meaning of Section 400.23(8). On December 23, 1999, Respondent conducted a follow-up survey. Respondent determined that Petitioner had corrected the deficiencies in Tag F314 and issued a "Standard" license pursuant to Section 400.23(8)(a). Respondent rated the severity of alleged deficiency between November 19 and December 23, 1999, with a rating of "II". A severity rating of "II" means the deficiency presented an immediate threat to the health, safety, or security of residents in the facility. Respondent is also required to rate the deficiency under a federal classification system. Respondent assigned a scope and severity rating of "G" to the alleged deficiency between November 19 and December 23, 1999. A "G" rating means an isolated incident creates actual harm to a resident, but the resident is not in immediate jeopardy. Applicable law requires that Petitioner post the conditional license in a conspicuous place near the entrance of the facility. Petitioner did so and filed a Petition for Formal Administrative Hearing with Respondent. The Petition challenged the finding of the November survey that Petitioner committed a Class II deficiency and also challenged Respondent's decision to issue a conditional license to Petitioner. Respondent referred the Petition to DOAH and this proceeding ensued. Open Areas A threshold issue is whether the resident developed pressure sores or whether the open areas were reddened areas or friction blisters that did not satisfy the definition of pressure sores. A pressure sore is defined in 42 CFR Section 483.25(c) as: . . . ischemic ulceration and/or necrosis of tissues overlying a bony prominence that has been subjected to pressure, friction or shear. Neither of the open areas over the resident's left and right hips satisfied the definition of a pressure sore. Neither open area was located over a bony area. Both wounds were located over a fatty area of the resident's hips. The medical records describe the area over the right hip as having peeled-back skin, being small in size, and having yellow slough. That description is consistent with chafing and is not descriptive of a pressure sore. Unlike the two open areas over the resident's hips, the open area over the resident's coccyx was located over a bony area of the tailbone. However, the small size and rapid healing time of two weeks are consistent with contact dermatitis caused by diarrhea rather than a pressure sore. The open area did not have the deep tissue damage associated with a pressure sore. Pressure sores start deep in the muscle and work their way to the surface. They are caused by prolonged pressure to skin over a bony area and typically require a prolonged healing time. The open area over the resident's right hip had healed by December 23, 1999, when Respondent conducted the follow-up survey. However, the open area over the resident's left hip had not healed as of the date of administrative hearing on May 12, 2000. The long healing time for the open area over the resident's left hip is consistent with a pressure sore even though the area is not located over a bony area. Petitioner performed an MRI bone scan to determine why the open area over the resident's left hip was not healing. The scan revealed that the resident had a prosthetic hip and that the prosthesis had loosened. The MRI scan noted that the "skin wound shows no associated bone activity." The failure of the wound to heal, more likely than not, was caused by stress on the resident's skin from the interaction between the loose prosthesis and the contraction and relaxation of the resident's muscles. The resident's clinical condition demonstrates that the occurrence of the open area over the resident's left hip and its failure to heal were unavoidable. Petitioner did not fail to provide the treatment and services necessary to prevent the open area over the left hip from developing. The treatment measures used by Petitioner for the open area over the resident's left hip included debridement, or surgical cleaning. Surgical cleaning of the open area is appropriate for a friction blister as well as a pressure sore. Unlike Respondent's witness, both of the witnesses for Petitioner actually observed the resident. The Director of Nursing and the nurse that testified for Petitioner both concluded that the three open areas on the resident were not pressure sores. Their testimony was credible and persuasive. Petitioner listed the three open areas at issue on the Pressure Ulcer Report in the medical records because that is the only form available to document open wound and treatment areas. The medical records contain six references that describe the three open areas on the resident as ulcers or decubitis wounds. Hundreds of other references in the medical records describe each of the three open areas as a wound, blistered area, or red area. Notice Assuming arguendo that the three open areas on one resident were pressure sores, a second threshold issue is whether the 2567 Report provides adequate notice of the charges against Petitioner. The parties agree that the 2567 Report charged Petitioner with allowing a pressure sore to develop and with failing to ensure that the resident received the care and services needed to prevent pressure sores from developing. However, the parties dispute whether the 2567 Report charged that Petitioner failed to provide the services necessary to promote healing. Tag F314 in the charging document provides notice to Petitioner in the following manner. Tag F314 first states the "Requirement" for the quality of care of each resident, then states the basis for the conclusion that the "Requirement" was not met for the resident, and finally states the "Findings" that allegedly support the conclusion. In relevant part, Tag F314 states: F314 483(25(c) Requirement SS=G Quality of Care (emphasis supplied) Based on the comprehensive assessment of a resident, the facility must 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 a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. (emphasis supplied) This requirement is not met as evidenced by: The facility did not ensure that [the resident] received the care and services to prevent pressure sores from developing. (emphasis supplied) Findings: Resident #4 was admitted 1/27/98 with diagnoses of dementia, bronchitis, thrombosis and embolism. Her MDS (Minimum Data Set) dated 6/18/99 indicated she had three (3) stage II pressure sores. These apparently healed because documentation in the nurses notes dated 9/10/99, noted "no open areas". Her care plan dated 9/20/99 noted open areas to the left hip, stage II, measuring 4 x 1.5 cm and right hip, unstageable, measuring 3 cm, and sacral area, stage II, measuring 2 cm. Documentation on 10/5/99 noted the coccyx was healed and on 10/12/99, left and right hips reddened stage I. On 9/16/99 at 10:55PM, documentation in the nurses notes indicated "3 x 3 red area left hip with 2 intact blisters below". The next note on 9/17/99 at 10:30 PM indicated "preventative skin care". The pressure ulcer reports noted that the pressure sore on left and right hips was first observed on 9/16/99 as stage I. On 9/20/99, four (4) days later, both pressure sores were noted as stage II, measuring 1 cm round with the left hip having serous drainage and the right hip having scant drainage. However, nurses notes documented on 9/20/99 that the pressure sore on right hip measured cm red with brown center, left hip measured cm red with 1.5 cm soft, open white/brown center, and sacral area 2 cm red open. By 9/24/99 documentation in the pressure ulcer report noted the left hip increased in size to 2.2 x 4 cm. Documentation noted right hip increased to 1.6 x 1.4 cm 10/21/99. Nurses notes dated 9/22/99 at 7:00 PM noted, "treatment orders received from doctor", six (6) days after the pressure sore was first observed and two days after the order was faxed to the physician. Interview with charge nurses on both units on 11/16/99, at 3:30 PM and 11/17/99 at 2:00 PM revealed they did not know why the resident had developed pressure sores. Observation of the pressure sore on 11/17/99 at 1:00 PM revealed the left hip measuring 1.5 x 2.5 cm with yellow slough and the right hip measuring 1.1 x 0.7 cm with a necrotic area on top. There was no way to determine what stage the pressure sore on the left hip was at this time since it was covered with slough. The charge nurse indicated that the pressure sores had become worse over the weekend. The resident was observed on 11/18/99 from 9:35 AM in bed, lying on her back and head of bed elevated 45 degrees, 10:20 AM, lying flat on her back in bed, 11:48 AM and 12:20 PM lying on her back flat in bed. The resident's position was changed at 1:30 PM when she was turned to her left side. During the course of the survey, the resident was never observed out of bed. Additionally, the resident had a 36 pound weight loss for one year and a 13 pound weight loss for six months. There was no documentation that the facility provided services necessary to ensure that this resident did not develop pressure sores and no documentation that the physician was notified promptly after the pressure sores were first observed. Documentation revealed that the facility notified the physician when the pressure sores on both hips were stage II and six days after they were first observed. (emphasis supplied) The express terms of Tag F314 do not charge that Petitioner failed to provide the resident with the necessary treatment and services to promote healing and prevent infection. Evidence of any alleged deficiency not contained in the express terms of the charging document are not relevant and material to the allegations in the charging document. Open Areas Were Unavoidable Assuming arguendo that one or more of the three open areas on the resident were pressure sores and that the 2567 support provided adequate notice of the charge that Petitioner's services failed to promote healing and prevent infection, two issues must be determined. One issue is whether the resident's clinical condition made the occurrence of the pressure sores unavoidable. The other issue is whether Petitioner failed to provide the treatment and services necessary to prevent the pressure sores. Respondent's witness did not evaluate whether the resident's open areas were avoidable. The witness did not offer an opinion on this issue. The resident was originally admitted to the facility in 1991. She has resided there since that time except for a number of brief trips to the hospital. She is a long-term resident of the facility whose needs are well known to facility staff. By 1999, the resident was a very sick woman. Her diagnoses included: Alzheimer's disease/dementia; low thyroid; psychosis; colostomy; artrial fibrillation; mitral valve prolapse; embolism; deep vein thrombosis; dysphagia; anorexia; bronchitis; urinary track infection; electrolyte and fluid imbalance; contractures; depression; intermittent edema; periodic diarrhea; chronic incontinence of bowel and bladder; and decreased tissue tolerance. The resident was routinely evaluated by Petitioner using a Minimum Data Set ("MDS") evaluation tool. The MDS assessment of April 14, 1999, identified the resident as being at risk for, among other things, the development of pressure sores and for weight loss. Petitioner developed a care plan to address these risks. The care plan for pressure sores included prompt cleaning and drying after each incidence of incontinence; regular monitoring of skin condition; a weekly skin assessment; encouraging the resident to maintain her nutrition and hydration; turning and repositioning the resident at least every two hours; and encouraging the resident to participate in movement oriented activities to relieve pressure points. When the resident's skin became compromised and reduced the turning surfaces, Petitioner brought in an air bed. In an effort to provide the resident with the best care possible, Petitioner upgraded the air bed several times without reimbursement. The parties agree that the resident's medical condition was highly compromised and that her condition deteriorated during 1999. She had numerous clinical comorbidities and became bedfast due to the development of contractures. The major problems that required constant monitoring and adjustment to the resident care plan included chronic incontinence of the bladder that resulted in excoriation and breakdown of the resident skin. Petitioner routinely used a Foley catheter for the resident to allow her skin to heal. Once the skin healed, the catheter was removed. Once the catheter was removed, the resident would suffer from renewed excoriation and breakdown of her skin. This cycle repeated itself throughout 1999. The resident also suffered from edema throughout 1999. This resulted in her being hospitalized on June 9, 1999. Whenever the resident experienced worsening of her edema, she would be put on Lasix. When her edema abated, Petitioner discontinued its Lasix. The resident experienced weight loss as her medical condition deteriorated. She weighed 162 pounds on January 15, 1999, and 121 pounds by August 15, 1999. Her weight stabilized in August, however, and never dropped below her ideal body weight. Petitioner tried numerous interventions to stabilize and increase the resident's weight. One intervention included dietary supplements. However, dietary supplements had to be discontinued because they caused diarrhea. The resident suffered from dysphagia that created difficulty in eating and swallowing. In an attempt to overcome this condition, Petitioner gave the resident speech therapy and put her on a pureed diet. Throughout 1999, Petitioner continued to evaluate the resident's condition and to provide her with the best possible care. Petitioner gave the resident MDS evaluations seven times between March and September, 1999. All of the resident's body functions, including skin integrity, were constantly on the verge of becoming dysfunctional. On September 12 and 13, 1999, the East Coast of Florida was threatened by Hurricane Floyd. Hurricane Floyd appeared to be heading straight for Titusville. The facility administrator monitored the national disaster center, the hurricane center, and the local weather information. The facility administrator decided that Petitioner should evacuate the facility to provide for the safety of the residents. The evacuation of a nursing home is a demanding task. All residents must be fed and have liquids during the transfer. The facility has to make sure that the residents' medications and medical devices and clothes will travel with the residents. Although Petitioner doesn't usually use adult diapers on its residents, it was necessary during transport from and back to the facility because there is no ability to change resident clothing during the trip. These tasks were made all the harder because Petitioner did not have its full complement of staff due to the hurricane. All in all, it took over five hours to load the residents onto the busses for evacuation. Petitioner evacuated the residents to three central Florida nursing homes that were also short-handed due to the hurricane. Petitioner sent the resident to Plantation Bay in Kissimmee, Florida. While she was there, it was impossible to implement every element of her care plan. Care focused primarily on feeding residents, seeing that they received their medications, and keeping them clean and dry. Petitioner transported the resident's air mattress to Plantation Bay. By September 15, 1999, Hurricane Floyd had passed, and the residents returned to the facility. This again necessitated packing the residents up, placing them in adult diapers, and transporting them back to the facility. When the staff and residents returned to the facility, they found that the electric power was out temporarily. The residents' clothes could not be washed immediately and the residents had to wear adult diapers until the power was restored. On September 16, 1999, the resident underwent a complete evaluation. At that time, it was noted that she had a 3 cm. X 3 cm. red area on her left hip with two small intact blisters below the reddened area. She did not have any open areas at that time. This area was examined again the next day. At that time, the facility was providing preventive skin care and was putting barrier cream on the left hip area. On September 19, 1999, the treating physician examined the resident, and did not note anything concerning her skin integrity. On September 20, 1999, the resident had open areas on her skin for the first time. The nurse's notes on that day describe three open areas as follows: On the right hip there is a 3 cm. open area with peeled skin and a 2 cm. brown center; on the left hip there is a 4 cm. red area with a 1.5 cm. open area with a white/brown center; and on the sacral area there is a 2 cm. open area. Facility staff notified the treating physician of this development and recommended that Allevyn bandages be prescribed for all three open areas. On September 22, 1999, the treating physician notified staff that he concurred with their recommendation. Within two weeks, the area of the coccyx/sacral area had healed completely. The right hip area was completely healed within two months. The left area still had not completely healed at the time of the Final Hearing and continues to be an area of concern and a focus of treatment. On November 15, 1999, before the state survey inspection started, Petitioner had a culture done on the resident's left hip to determine if that area was infected. The results of that laboratory test showed that the area was not infected. On November 23, 1999, Petitioner debrided, or surgically cleaned, the open area on the resident's left hip in an effort to promote healing. On December 23, 1999, Petitioner had a bone scan done to the area of the resident's left hip. The scan noted that there was a possible loosening of the resident's prosthesis and that the "skin wound shows no associated bone activity". Petitioner did everything reasonably possible to prevent the resident from developing pressure sores and to treat the open areas. Petitioner performed seven MDS assessments between March and September, 1999, four Braden assessments during that period, and a weekly head-to-toe skin assessment. Petitioner inspected for skin integrity during the resident's twice-weekly showers. Petitioner turned the resident and repositioned her at least every two hours. In addition, Petitioner turned and repositioned the resident every time she was treated for incontinence and after each meal. Petitioner made every effort to keep the resident dry and clean, even though she had chronic incontinence. Petitioner routinely placed the resident on a catheter to allow her skin to heal. Once her skin was intact, the catheter was removed. However, incontinence led to further skin breakdown that, in turn, led to the catheter being put back in place. Petitioner used a barrier cream in an effort to keep the resident skin dry and clean. When indicated, Petitioner put heel-protecting booties on the resident. When the resident turning surfaces became weakened, Petitioner obtained a pressure- relieving air mattress without reimbursement and upgraded the mattress several times. Proper Care Respondent contends that Petitioner failed to provide the resident with the necessary treatment and services to promote the healing of her pressure sores and that the result of this failure was the development of infections. The particular treatment and services that Respondent alleges Petitioner did not provide are turning and repositioning the resident; notifying the resident doctor in a timely manner after the development of the open areas; and failure to address weight loss. Turning and repositioning a resident who is at risk for the development of pressure sores, or who has developed pressure sores, is a standard intervention. It keeps a resident from having prolonged pressure over any one bony prominence. The standard protocol in the industry calls for a resident to be turned and repositioned at least every two hours. Respondent asserts two grounds for finding that the resident was not turned and repositioned every two hours. First, the nurse's notes do not always state that the resident was turned and repositioned. Of 720 possible opportunities to note turning and repositioning between March 24 and November 19, 1999, the nurses' notes contain 105 entries that refer to turning and repositioning. According to Respondent's expert witness, if turning and repositioning isn't in the chart, it didn't occur. The resident was extremely compromised and was at great risk for the development of pressure sores. If the resident had been turned and repositioned only 105 times of 720 opportunities, she would have developed serious pressure ulcers on all of her weight-bearing surfaces including her heels, knees, and ankles. She would have developed Stage IV ulcers on her heels and sacrum had she not been regularly turned and repositioned. The absence of pressure sores on the resident is persuasive evidence that Petitioner regularly turned and repositioned the resident. There is no requirement or nursing standard that routine care such as turning and repositioning must be charted. Routine care is sometimes charted by nurses out of habit, but charting turnings and repositionings is not mandatory. The resident's records show that charting of certain routine items was irregular. For example, the air mattress for the resident remained in place once it was put in place. The resident's chart notes the presence of an air mattress on June 6, 8, 11, and 17. There is no mention of the air mattress in the nurses' notes of June 9, 10, 13, 14, 15, 18, 19, or 20. There are multiple nurses' notes on June 12, 21, 24, 26 and 30, wherein one of the notes mentions the air bed and others do not. Similarly, the charts note that the resident had open areas to her skin for September 16, 20, 30, and October 4 and 5, 1999. The nurses' notes for September 17, 22, 24, 29, and October 7 and 8, 1999, do not mention the resident's skin condition. The surveyor noted in relevant part: The resident was observed on 11/18/99, from 9:30 AM in bed, lying on her back and the head of bed elevated 45 degrees, 10:20 AM, lying on her back flat in bed, 11:48 AM and 12:20 PM lying on her back flat in bed. The resident's position was changed at 1:30 PM when she was turned to her left side. From this recitation, Respondent infers that the resident was not turned and repositioned for a four-hour period on November 18, 1999, and was not, therefore, regularly turned and repositioned. The resident had severe contractures that resulted in her left leg being pulled way up and across her body. Due to this condition, the resident could appear to be lying flat on her back when she was either on her back or when she was actually on her right side. The surveyor did not enter the resident's room when the surveyor made the observations contained in the survey report. The surveyor merely observed the resident briefly from the hallway. The surveyor mistakenly believed the resident was on her back when she was actually on her right side. The Director of Nursing was aware that the resident was a focus of the survey. The Director directed her CNA's, her wing managers, and her Assistant Director of Nursing to be sure that the resident was regularly turned and repositioned. The Director personally checked to confirm that the resident was regularly repositioned. She knew of her own knowledge that the resident was turned and repositioned at least every two hours and identified the person who physically did the turning. Respondent asserts that Petitioner was deficient because it did not notify the resident's doctor of her skin condition for a period of six days. Respondent bases this allegation on the fact that the first red area on the resident was observed on September 16, 1999, and the doctor's concurrence of staff's recommended treatment was not received until September 22, 1999. The resident's treating physician visited her at the facility on September 19, 1999. He did not determine that additional treatment orders were needed at that time. Facility staff first noted open areas on the resident on September 20, 1999, and notified the treating physician on that day. In the notification, staff requested that the physician approve a treatment plan that called for "cleanse w/ N/S then apply Requesting Allevyn Islands for all three. Change every three days & prn." The physician was out of town, but approved the recommendation when he returned on September 22, 1999. The resident's physician visited her after the red area was observed on her left hip, but before it became open. Petitioner notified the physician immediately upon noting the open areas. The two-day delay in getting confirmation of the recommended treatment was caused by the physician's absence and not by Petitioner. Respondent's witness testified that the resident's weight loss "was a factor that influenced the clinical outcome of the pressure ulcer," that it "was a tangible manifestation of some type of physiological symptom failure," and that the weight loss indicated that the resident was at risk for developing pressure sores. However, Petitioner knew that the resident was at risk for developing pressure sores. Petitioner prepared and implemented numerous care plans to deal with this risk. Respondent did not allege that the nutritional services provided to the resident were inadequate. The resident never dropped below her ideal body weight. The resident stabilized in August 1999, approximately 123 pounds. Petitioner provided the resident with speech therapy for dysphagia and difficulty with swallowing and digestion. Petitioner provided the resident with dietary supplements to increase her caloric intake. The supplements were discontinued because they caused diarrhea. Petitioner placed the resident on a pureed diet in an effort to make her food easier to eat. A dietitian evaluated the resident 23 times between May 27 and December 8, 1999. Respondent did not identify any dietary or nutritional intervention that Petitioner should have taken, or any ill- advised nutritional treatment that Petitioner did provide. Petitioner was aware of the resident's weight loss, constantly evaluated and reevaluated her nutritional needs and strategies for meeting them, and successfully halted her weight loss while she was still within her ideal body weight and before she suffered any breakdown of her skin. No nutritional deficiency was shown. Respondent infers that the resident's wound to her left hip became infected because it was noted at one time in the nurse's notes to have a foul odor and pus. As a part of the treatment of the resident's left hip, Petitioner applied Hydrogel directly on the wound and Polyskin over that. The dressing remained in place for three days. The dressing created a foul odor as it disintegrated over the three days it was in place. As the serous drainage of the wound mixes with the medication, it creates the appearance of pus. Petitioner had a culture done to test for infection. The culture test was ordered before the survey inspection. The test demonstrated that the resident did not have an infection. In addition, the resident's physician never prescribed an antibiotic for infection. At the time of the inspection, the resident census at the facility was 113. Of those, at least 50 percent were identified as being at risk for the development of pressure sores. Based on the national average of a 7-9 percent incidence of pressure sores on nursing home residents, one would expect that the facility would have 8 to 10 residents at any one time with pressure sores. The resident was the only resident Respondent alleged to have pressure sores. Class II Rating Assuming arguendo that the resident did actually develop three pressure sores, the greater weight of the evidence suggests that she was turned and repositioned on a regular basis at least every two hours; that her physician was properly kept abreast of changes in her condition; that her nutritional status was regularly evaluated and every effort was made to maintain her weight; and that her wounds did not become infected and were superficial and relatively mild. As such, it was not proven that the alleged deficiencies had more than an indirect or potential relationship to the health, safety, or security of the resident. The alleged deficiencies should have therefore been classified as no more than Class III deficiencies, and Petitioner should not have been issued a Conditional license.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order finding Respondent not guilty of the alleged deficiency and reinstating Respondent's license rating to standard for the period between November 19 and December 23, 2000. DONE AND ENTERED this 27th day of September, 2000, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 September, 2000. COPIES FURNISHED: Mark S. Thomas, Esquire Michael Hope, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-0543 R. Davis Thomas, Jr., Qualified Representative Jay Adams, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Tallahassee, Florida 32301 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 Paul J. Martin, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308-5403
The Issue The issue to be presented is whether Respondent violated section 458.331(1)(t), Florida Statutes (2005), and if so, what penalty should be imposed?
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Respondent, John Lee, M.D., is a licensed physician in the State of Florida, having been issued license number ME 50043. Dr. Lee specializes in obstetrics and gynecology, but is not board certified at this time. He has a solo practice. Dr. Lee has had one prior final order imposing discipline against him. On November 7, 1996, the Board of Medicine entered a Final Order approving an amended Consent Agreement entered between the Agency for Health Care Administration (the Department's predecessor with respect to regulation of health care professionals) and Dr. Lee. The Final Order imposed a letter of concern, a fine of $2,000, and 20 hours of continuing medical education. On or about November 2, 2005, patient R.R. first saw Respondent with a complaint of chronic pelvic pain and an inability to function. Based upon his examination of R.R., Respondent recommended that R.R. undergo a bilateral salpingo- oophorectomy (removal of both ovaries and fallopian tubes). R.R. decided to have the recommended surgery and on December 13, 2005, Respondent performed a bilateral salpingo- oophorectomy, as well as an appendectomy, lysis of adhesions and partial omentectomy. There are three layers to the bowel: the serosa is the thin outer protective layer; under the serosa is the muscularis; a third layer below the muscularis called the mucosa. Dr. Lee's surgical notes indicate that there was some serosal denuding of the sigmoid colon, but with no luminal extravasion (no leakage from the bowel). Dr. Lee described the serosal denuding as an irritation of the serosa from removal of adhesions, and not a complication of the surgery. In any event, there are no allegations in the Administrative Complaint claiming that either Dr. Lee's decision to perform the surgery or the performance of the surgery itself deviated from the appropriate standard-of- care, and no findings to that effect are found. R.R. was discharged from the hospital on December 15, 2005. At that time, she was ambulatory, tolerating liquids, had passed flatus and had a small bowel movement. At that time she had no documented fever and a normal white count. The next day, Friday, December 16, 2005, R.R.'s husband called Dr. Lee's office at approximately 3:00 p.m. According to R.R., she spoke to Brandi Melvin, now known as Brandi Harper (Ms. Harper), the medical assistant for Dr. Lee, and told her that she was running a fever of 101.8 degrees, did not feel well and wanted Dr. Lee to call her. She testified that at that time, she did not feel well, was achy all over, had pain in her abdomen and had chills. R.R. testified that Ms. Harper told her to increase her Dilaudid in accordance with her prescription and to continue rotating Tylenol and Motrin. She denies being told to go to the emergency room if her fever did not go down, and denies being instructed to pick up a prescription for an antibiotic. Brandi Harper is a medical assistant in Dr. Lee's office, and has been since 2004. She is a certified nurse's assistant and has completed a year and a half toward her registered nursing degree. Part of Ms. Harper's duties include screening calls that come in from patients post-surgery. In doing so, she follows a set protocol that has been established in that office. In accordance with Dr. Lee's preferences, she inquires not only about the symptoms the patients report having, but also about symptoms they may not be having. Consistent with that protocol, she testified that, with respect to the call from R.R. and her husband, she asked whether R.R. was having any drainage from the incision; any abdominal pain; or was experiencing any other symptoms. Ms. Harper testified that R.R. did not report having any abdominal pain above expected soreness, and did not report difficulty breathing or shortness of breath; drainage from the incision; vomiting; bloating or distension of the abdomen. Ms. Harper's testimony is credited. After receiving the telephone call from R.R., Ms. Harper wrote a note to Dr. Lee which referenced R.R. and stated, "[t]aking the cephalexin you gave her on discharge. Is running 102 temp, just sore. She has been rotating Tylenol and nothing has brought it down. Informed her to drink plenty of fluids. Do you want to add anything?" Neither Ms. Harper's notes nor her testimony reflect that she told the patient to increase pain medication. Nor does the note reflect that R.R. wanted to speak with Dr. Lee. Because Dr. Lee was seeing patients, Ms. Harper placed the note on his desk for his review. After reviewing the note, Dr. Lee wrote "Levaquin 500mg, #10, 1 a day." Ms. Harper then called the patient to tell her that a prescription was being called in for her and confirmed the pharmacy the patient used. At that time, consistent with the protocol established by Dr. Lee, she told R.R. or her husband that if the fever did not go down after two hours, to go to the emergency room at West Florida Hospital. She did not tell her to call the office back because, at the time of the return phone call, it was approximately 3:30 p.m. on a Friday afternoon, and in two hours the office would be closed. Ms. Harper then called the prescription in to Burklow's Pharmacy, as identified by the patient, and noted the prescription in patient's medication log. She noted the time of the call and the name of the pharmacist with whom she spoke. Ms. Harper did not note in the medical record that she advised the patient to go to the emergency room if her fever did not go down, and did not specifically note the return call to the patient. However, she plausibly explained that she could not call in the prescription to Burklow's without speaking to the patient, because there were two different pharmacies noted in her file previously. She also credibly testified that she always calls the patient back in conjunction with the call to the pharmacy, and gives standard instructions to post-operative patients regarding further action (in this case, going to the West Florida Hospital emergency room) should their condition not change. She does not necessarily document the return call because she does it so many times daily. Dr. Lee also testified that instructions to call back if the office is open or go to the emergency room if symptoms do not improve in a few hours is part of the standard protocol. Ms. Harper's and Dr. Lee's testimony is credited. R.R. did not go to the emergency room over the weekend and there was no evidence that she ever called Dr. Lee's office back after the 3:00 Friday afternoon call. She continued to not feel well, however, and on Monday morning, December 19, 2005, at approximately 5:00 a.m., she woke up in intense pain between her shoulder blades. She went by ambulance to Santa Rosa Medical Center (SRMC). R.R. went to SRMC as opposed to West Florida Hospital because it was much closer to her home. Dr. Lee does not have privileges at SRMC. Although R.R. went to the emergency room early December 19, 2005, there was no determination that first day that she had a bowel perforation, and she was not admitted to the hospital until approximately 8:30 that evening. At the time of admission, she had a white blood count of 3.3, with a differential count of 12 neutrophil bands. The history and physical taken at the hospital and signed by Dr. Michael Barber, M.D., states in part: HISTORY OF PRESENT ILLNESS: [R.R.] is a 33- year-old, . . . who underwent abdominal surgery six days ago by Dr. John Lee at West Florida Hospital. She had bilateral salpingo-oophorectomy, partial omentectomy, appendectomy, and extensive adhesiolysis. . . . She states that although this surgery was prolonged and reportedly difficulty (sic), she tolerated the surgery well and by the second postoperative day was ambulating and voiding freely, tolerating a regular diet with a bowel movement and positive flatus. She stated her pain was well managed with 4 mg of Dilaudid q4h as needed. She was sent home on Cephalexin 500 mg q6h, Phenergan 25 mg q6h and Dilaudid 4 mg q6h. She was also on Hydrochlorothiazide for chronic hypertension, Klonopin and Effexor for anxiety and depression. She states that after going home she had some anorexia that was doing well until the morning of admission. She was awakened from her sleep at approximately 6 a.m. with remarkable abdominal distention and severe diffuse abdominal pain. She developed nausea as the pain progressed but has had no vomiting. She states that other than the bowel movement immediately post surgery, she had not had any bowel activity since discharge in six days. After several hours and worsening of pain, she presented to the emergency room at Santa Rosa Medical Center. On admission, a CT scan of the abdomen was accomplished and revealed a moderate volume loss infiltrate in the left lung base, apparent present to a lesser extent on the right. There was free air noted within the abdomen and also noted to be some free fluid. This was felt to be due to the patient's prior surgery, however, a more acute process could not be ruled out. There were also some distended loops of small bowel with apparent decompression of the distal small bowel which suggested at least a partial small bowel obstruction, although again, the diagnosis included ileus. A CT of the pelvis was unremarkable except as noted on the CT scan. There was some free fluid and free air within the pelvis. Since transfer to West Florida Hospital and the patient's attending physician could not be arranged, decision was made to admit to Dr. Barber on GYN service. * * * IMPRESSION: Severe abdominal pain 6 days post exploratory surgery with bilateral salpingo-oophorectomy, partial omentectomy, appendectomy and adhesiolysis. No signs at this time of active infection or perforation. The most likely diagnosis is a severe postoperative ileus, however, the patient warrants close observation. An ileus occurs when the bowel is "asleep" and not moving. Dr. Barber transferred R.R. to the Intensive Care Unit overnight for close observation. R.R.'s temperature at the time of admission was 96.8. The History of Present Illness taken from R.R. does not mention the rise in temperature following discharge from West Florida Hospital, or the phone call to Dr. Lee's office. On December 20, 2005, Dr. Althar saw R.R. in consultation. At that time, her white count was 8.4 with 48 bands, indicating overwhelming sepsis. Dr. Althar took her immediately to surgery. Surgery revealed a bowel perforation of the sigmoid colon, and Dr. Althar performed a sigmoid colectomy, end colostomy, and Hartmann procedure. R.R. suffered some complications after surgery, which were not unexpected, and remained in the hospital until her discharge January 16, 2006. The Department presented the expert testimony of Robert W. Holloway, M.D. Dr. Holloway graduated from Vanderbilt University Medical School; completed his residency in Obstetrics and Gynecology at the University of Alabama at Birmingham; and completed a fellowship in gynecology oncology at Georgetown University Hospital. Dr. Holloway has been licensed as a medical doctor in Florida since 1990, and is board certified in obstetrics and gynecology, and gynecologic oncology. He is currently the co-Medical Director of the Gynecologic Oncology program at the Florida Hospital Cancer Institute in Orlando, Florida, and a clinical instructor for the Obstetrics and Gynecology Residency Program at Orlando Regional Medical Center. Dr. Holloway is in an office on the Florida Hospital campus, where there are four attending physicians and three follows in training. Fifty to 60 percent of his patients are oncology patients, with the remainder having benign issues. Dr. Holloway opined that in this case, the bowel perforated most likely late Sunday evening or early Monday morning, probably 6-12 hours before R.R. woke up in extreme pain. He found no violation of the standard-of-care regarding the denuding of the serosa in the original surgery, viewing it as an anticipated outcome with a difficult case of endometriosis. However, he opined that Dr. Lee fell below the appropriate standard-of-care when he failed to evaluate the patient on Friday afternoon when she had a temperature of 102 degrees. Dr. Holloway indicated that the most common indications of bowel perforation in post-operative patients are abdominal pain and fever. He knew of no cases where a perforation occurred with the patient presenting with fever alone. He also agreed that it is common for physicians to rely on their staff to triage patients, and to relay information back to patients. It is common, according to Dr. Holloway, for doctors to train staff to tell the patient to call back or go to the emergency room if a problem does not resolve itself, and staff normally does the majority of charting. With respect to the directions to the patient to call back or go to the emergency room, Dr. Holloway could not say that those directions are always noted in the chart for patients in his office, although they frequently are. Most importantly, Dr. Holloway could not conclude that Ms. Harper did not give the instructions to R.R. because it was not specifically noted in the chart, and he would be apt to give the staff the benefit of the doubt. He could not conclude from the absence of the note that proper instructions were not given. Dr. Holloway also indicated that he did not believe the bowel had perforated as of Friday afternoon when the call was made to Dr. Lee's office. Respondent presented the testimony of John Douglas Davis, M.D., who serves as the Director of Gynecology and Associate Residency Director of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine. Dr. Davis graduated from medical school at Wake Forest University and received his post-doctoral training at the University of Florida. Dr. Davis is licensed as a medical doctor in the State of Florida, and has been board certified in obstetrics and gynecology since 1992. Ninety-five percent of his patients are gynecological patients. Dr. Davis did not believe that Respondent violated the appropriate standard-of-care in his treatment of R.R. He opined that it is reasonable to rely on staff to perform triage functions with respect to calls from patients, and would interpret the note from Ms. Harper as not being indicative of bowel perforation. He testified that it was more likely to assume that the fever was caused by a pulmonary source, and the prescription for Levaquin was consistent with that assumption. In addition, the CT scan upon admission to SRMC was consistent with findings of pneumonia, and in Dr. Davis' view, the eventual determination that the bowel perforated does not mean that pneumonia was not also present. Like Dr. Holloway, Dr. Davis testified that bowel perforation does not present without severe abdominal pain, which was not reported to Dr. Lee. Dr. Davis opined that R.R.'s fever of 102 degrees must be interpreted in light of the patient's situation at discharge from the hospital, which Dr. Lee already knew. Most importantly, Dr. Davis testified that not seeing R.R. on Friday afternoon did not have an impact on her subsequent clinical course. His testimony is credited. In summary, it is found that Ms. Harper did instruct the patient to go to the emergency room at West Florida Hospital should her symptoms not improve after a couple of hours with the new medication. Dr. Lee's reliance on her to give that instruction is within the standard-of-care for a reasonably prudent similar physician under similar conditions and circumstances.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED that the Florida Board of Medicine enter a Final Order dismissing the Administrative Complaint in its entirety. DONE AND ENTERED this 23rd day of September, 2011, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 23rd day of September, 2011. COPIES FURNISHED: Elana J. Jones, Esquire Ian Brown, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Brian A. Newman, Esquire Pennington, Moore, Wilkinson, Bell and Dunbar, P.A. 215 South Monroe Street, Second Floor Post Office Box 10095 Tallahassee, Florida 32302 Nicholas W. Romanello, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32299-170 Joy A. Tootle, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399
Other Judicial Opinions A party who is adversely affected by this final order is entitled to judicial review pursuant to Sections 120.68 and 766.311, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original of a notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a copy, accompanied by filing fees prescribed by law, with the appropriate District Court of Appeal. See Section 766.311, Florida Statutes, and Florida Birth-Related Neurological Injury Compensation Association v. Carreras, 598 So. 2d 299 (Fla. 1st DCA 1992). The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.
Findings Of Fact Petitioner applied to the Board of Medicine for licensure by endorsement as a physician in the State of Florida. The Board of Medicine is the regulatory agency in the State of Florida charged with the duty to regulate the practice of medicine in the state, including the licensure of physicians. Petitioner has been in psychotherapy as a patient of Dr. Stanley G. Garner since 1986. Dr. Garner was qualified and accepted as an expert witness in the speciality of psychiatric medicine. Petitioner began psychotherapy with Dr. Garner and has remained in therapy with him on a voluntary basis. The purpose and emphasis of Petitioner's psychotherapy has been the identification and resolution of ongoing family problems, including marital and divorce issues, which have been imposed upon an earlier history of being raised in a dysfunctional family. Petitioner was very upset when she first saw Dr. Garner in 1986 due to events that resulted in protracted divorce proceedings. The purpose of Petitioner's therapy has never been to assess or ensure Petitioner's fitness to practice medicine since this was never a therapeutic issue to either the Petitioner or to Dr. Garner. Petitioner's psychotherapy has been directed towards improving her comfort, happiness, and quality of life. Dr. Garner has spent over 400 hours in therapy with Petitioner and has diagnosed Petitioner as having Dysthymia, which is a fairly recent term for a depressive condition that used to be called neurotic depression or depressive neurosis. Dysthymia was described by Dr. Garner as being an extremely common condition and one that is shared by many of his physician patients without impairment of their ability to perform as physicians with reasonable care and skill. According to the Diagnostic and Statistical Manual of the American Psychiatric Association, the diagnosis of Dysthymia has to include the presence of at least two of the following conditions while depressed: (1) poor appetite or over eating, (2) insomnia or hypersomnia, (3) low energy or fatigue, (4) low self esteem, (5) poor concentration or difficulty making decisions, (6) feelings of hopelessness. Dysthymia does not usually lead to sudden changes in personality or behavior, and Dr. Garner has noted no sudden changes in Petitioner's personality during the course of his treatment of her. Petitioner's application reflected that she had undergone psychotherapy as a patient of Dr. Garner since 1986. In response to the application, Respondent required information from Dr. Garner as to Petitioner's treatment. By his letter of July 17, 1991, Dr. Garner provided Respondent with historical information as to Petitioner's condition and her psychotherapy and advised Respondent, in pertinent part, as follows: Dr. Shienvold has been in psychotherapy with me, on a regular basis, since 9/13/86 for treatment of her depressive disorder. She is currently being seen weekly in individual psychotherapy and weekly in group psychotherapy. The frequency of her visits has varied during the course of her treatment. Currently, she is taking Prozac 20 mg. each morning; this medication seems to be helping her cope with the many pressures of her current life situation. She was not on medication during most of her time in therapy. * * * Dr. Shienvold's diagnosis is Dysthymia (300.40 DSM III-R). She has never shown any evidence of a psychotic disorder and has no history of, nor propensity for, substance abuse. Her prognosis is excellent, but she definitely needs ongoing psychotherapy for the foreseeable future. There are still many current vocational, financial, familial, and parental pressures which impede her more rapid progress. I have no doubt, however, that she will overcome these obstacles and continue to be a dedicated and hard working physician. This applicant for medical licensure, in my professional opinion, will certainly be able to practice medicine with reasonable skill and safety. Given her very high level of intelligence and her rapidly increasing fund of knowledge and experience, along with her genuine caring devotion to her patients, I am convinced that Dr. Shienvold will become a truly outstanding physician and do honor to our profession. If my comments seem flowery and excessive, it is because in my almost 35 years as a physician, and as a psychiatrist to a large number of fellow physicians, I have only rarely seen someone as qualified to practice Medicine as Frances Shienvold. As part of the application process, Respondent arranged for the Physician's Recovery Network (PRN) to have Petitioner examined by an independent psychiatrist. This examination was performed in January 1992 by Dr. Burton Cahn. On February 24, 1992, Dr. Cahn submitted his report to Dr. Goetz by letter. Dr. Cahn's letter provided, in pertinent part, as follows: At the present time, I see no reason why Dr. Shienvold would be unable to practice medicine because of a mental or emotional condition. She is not psychotic. She is not a substance abuser. She is not at this time significantly depressed. She does not represent a danger to herself or to others. I therefore find no reason on a mental or emotional basis that Dr. Shienvold is unable to practice medicine. The record in this proceeding is not clear when the idea that a monitoring contract with the PRN would be deemed necessary by the Board of Medicine. It is apparent from Dr. Garner's follow-up letter to the Board of Medicine on January 16, 1992, that Petitioner was aware at that time that such a condition may be imposed on her licensure by Respondent. Dr. Garner's letter of January 16, 1992, provided, in pertinent part, as follows: It is my professional opinion that the assignment of Dr. Shienvold to the Physicians Recovery Network was an error. The requirement that she sign an Advocacy Contract with "PRN" is inappropriate for her situation, and would be for anyone else with her particular medical/psychological history. There is certainly no need for any kind of "monitoring" of her continuation in psychotherapy. . . . * * * In summary, I believe that Dr. Shienvold should be granted her Florida license to practice medicine without any special conditions or restrictions. . . . * * * Her diagnosis remains the same (Dysthymia), and her prognosis is excellent. By letter dated February 26, 1992, Dr. Goetz advised the Board of Medicine that "Dr. Cahn finds no reason why Dr. Shienvold would be unable to practice medicine with reasonable skill and safety." Dr. Goetz's letter of February 26, 1992, also provided the following: "If the Board chooses to license this applicant, I would be pleased to monitor Dr. Shienvold's continuing treatment with a PRN contract." By Order dated March 16, 1993, the Board of Medicine approved Petitioner's application for licensure by endorsement with a condition. The Board's Order provided, in pertinent part, as follows: You are hereby notified pursuant to Section 120.60(3), Florida Statutes, that the Board of Medicine voted to APPROVE with certain requirements your application for licensure as a physician by endorsement. The Board of Medicine reviewed and considered your application by endorsement on October 2, 1992, in Miami, Florida and has determined that said licensure by endorsement be APPROVED with the requirement that you establish a monitoring contract with the Physician Resource Network (PRN). The Board stated as grounds therefore: That you have a history of successful psychotherapy for a depressive disorder that requires ongoing treatment. Although your ability to practice medicine has not been compromised, it is appropriate to establish monitoring to ensure continued successful treatment. At its February 6, 1993, meeting in Jacksonville, Florida, the Board denied your request for reconsideration of this matter. The requirement set forth herein is a requirement for licensure and should not be interpreted or applied as disciplinary action by the Board. The Physician's Resources Network referred to by the foregoing Order is the same organization as the Physician's Recovery Network. The PRN is also referred to as the Impaired Practitioner Program. The purpose of the PRN program is to protect the public by assuring the health and well being of licensed health practitioners in the State of Florida. Dr. Garner's testimony at the formal hearing was consistent with the opinions he expressed in his two letters to Respondent. Petitioner has been responsible in securing appropriate medical care for herself including psychiatric care, and has been a cooperative patient while under Dr. Garner's care. For most of her psychotherapy, Petitioner has been seeing Dr. Garner twice a week. At the time of the formal hearing, she was seeing him once a week. Dr. Garner has no reason to believe that she would irresponsibly discontinue her therapy or become uncooperative in the foreseeable future. Petitioner has not suffered severe Dysthymia, but she has been at times severely depressed. Those occasions when she was severely depressed were in reaction to her mother's death and in reaction to her abandonment by her father and by her husband. Prior to entering medical school, Petitioner held a Ph.D. in cell biology and anatomy. Over the past seven years she has gone through a divorce, reconciled with her mother, suffered the death of her mother, become estranged from her father and stepmother, and completed medical school. At the time of the formal hearing, she had almost completed her residency. Petitioner has never been found to be unfit to practice medicine with requisite levels of skill and care at any time during her residency. Petitioner has participated in a residency program at Jackson Memorial Hospital for approximately three years. The residency program includes participation in out patient clinics at Mt. Sinai Hospital and service in regular hospital wards, the emergency room, intensive care units for both neonatal patients and other pediatric patients. As a resident, Petitioner worked under the general supervision of a licensed physician, but she had ample opportunity to independently exercise her professional responsibilities and judgment. Petitioner's ability to practice medicine with fitness and safety has not been impaired by Dysthymia, any other mental or emotional condition, or the medication she takes for the Dysthymia. Her memory has not been impaired. At any given time, a person suffering from depression can have difficulty in concentrating or in making decisions. The evidence in this proceeding established that Petitioner's ability to concentrate and to make decisions in the day to day practice of her profession has not been impaired. Her interest in her patients has not been impaired. She does not suffer from unusual fatigue. Petitioner has various medical conditions that add stress to her life. She suffers from sinus problems which have resulted in surgery and ongoing treatment for infections, hypertension, hyperthyroidism, gastritis which includes duodenitis, and esophageal reflux. Petitioner continues to suffer financial and family problems relating to her father, stepmother, brother, and son. Petitioner can still become very upset at times. It is anticipated that Petitioner will remain under Dr. Garner's care for at least one more year. Petitioner intends to continue in psychotherapy until her symptomology is fully resolved. Dr. Garner considers Petitioner's prognosis to be excellent, but is of the opinion that she needs ongoing psychotherapy for the foreseeable future. Dr. Garner is of the opinion that Petitioner could practice medicine with the requisite skill and safety if she were to discontinue psychotherapy completely. At the time of the formal hearing, Petitioner had been taking Prozac for approximately two years. Prozac is an antidepressant which helps Petitioner keep her mood at a high level while she deals with difficult problems in psychotherapy. Dr. Garner is of the opinion that Petitioner can practice medicine with the requisite level of skill and safety without Prozac. He is of the opinion that it is best for her to continue to take Prozac and that there are no significant side effects to the medication. Dr. Roger Goetz is the director of the PRN program and was accepted as an expert in Respondent's impaired practitioner program. The purpose of a monitoring contract with the PRN is to monitor whether there is a failure of a participant to progress in psychotherapy, if there is a change in medication, if there is any discontinuance of therapy, or if there is a change of treating professionals. Dr. Goetz considers the monitoring contract to be the least intrusive way to establish a relationship between the participant and the PRN program. Dr. Goetz is of the opinion that it is in Petitioner's best interest and the best interest of the public that she be in a monitoring contract with the PRN as a condition of her licensure because the contract would provide confirmation that Petitioner is doing well in her therapy before it became necessary to institute a disciplinary action or investigation, the contract would ensure that no abnormal transference was going on, and the contract would, in light of her psychiatric treatment, give assurance that she poses no problem to the public welfare. Dr. Goetz made it clear that he was testifying as the Director of the PRN and that he was not attempting to speak on behalf of the Board of Medicine. He also made it clear that it was the responsibility of the Board of Medicine to decide whether a practitioner needs services from the PRN and that the PRN becomes involved after the Board of Medicine determines that a practitioner needs its services. The terms and conditions of the monitoring contract would be negotiated by the parties after the Board of Medicine enters a Final Order that requires the imposition of a monitoring contract. Because those negotiations have not occurred, Dr. Goetz could only testify as to the terms he would expect to be contained in a monitoring contract. In addition to the reports required of the treating psychiatrist, the contract would confer on the PRN the authority to require Petitioner to withdraw from practice for evaluation if the PRN determines that "any problem" has developed. The monitoring contract is expected to be of at least five years duration and, according to Dr. Goetz, be imposed as long as Petitioner is in therapy without regard to the purpose or the nature of her therapy. Dr. Garner is of the opinion that PRN monitoring would impede rather than ensure Petitioner's progress in therapy because it would diminish the underlying confidentiality of therapy. From the proceedings before the Board of Medicine, it is apparent that the board considered the information contained in Petitioner's application file, including the opinions expressed by Dr. Garner and by Dr. Cahn before entering its Order of March 16, 1993. At the formal hearing, there was no articulation of the reasons the Board of Medicine had for determining that Petitioner's history of psychotherapy and the fact that the psychotherapy was ongoing justified the imposition of the monitoring contract with the PRN.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order which unconditionally grants Petitioner's application for licensure to practice medicine by endorsement. DONE AND ENTERED this 29th day of November, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 29th day of November, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-3038 The following rulings are made on the proposed findings of fact submitted by Petitioner. The proposed findings of fact in paragraphs 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 22, 25, 26, 27, 29, 32, 33, 34, and 40 are adopted in material part by the Recommended Order. The proposed findings of fact in paragraph 2 are adopted by the Recommended Order or are subordinate to the findings made. The proposed findings of fact in paragraphs 19, 20, 21, 23, 24, 28, 30, 31, 35, 36, 37, 42, and 43 are subordinate to the findings made. The proposed findings of fact in paragraphs 38 and 41 are rejected as being unnecessary as findings of fact, but are consistent with the conclusions reached. The proposed findings of fact in paragraph 39 are rejected as being speculative. The proposed findings of fact in paragraph 44 are rejected as being unnecessary to the conclusions reached. The following rulings are made on the proposed findings of fact submitted by Respondent. The proposed findings of fact in paragraphs 1, 2, 3, 4, 5, 7, 8, 10, 11, 13, and 14 are adopted in material part by the Recommended Order. The proposed findings of fact in paragraphs 6 and 9 are adopted in part by the Recommended Order. These proposed findings of fact are, in part, rejected as being inconsistent with the findings made. The proposed findings of fact in paragraph 12 are adopted as being opinions expressed by Dr. Goetz. COPIES FURNISHED: Howard J. Hochman, Esquire 1320 South Dixie Highway, Suite 1180 Coral Gables, Florida 33146 Claire D. Dryfuss, Esquire Assistant Attorney General Office of the Attorney General The Capitol, PL-01 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Board of Medicine Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jack McRay, Acting General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0770
