The Issue The issue for consideration in this case is whether Respondent should be issued a standard or a conditional license for the period beginning August 5, 1998.
Findings Of Fact At all times pertinent to the issues herein, the Agency for Health Care Administration (Agency) was the state agency in Florida responsible for the oversight, licensing, and regulation of skilled nursing facilities (SNF) in this state. Emerald Oaks, is a SNF located at 1507 South Tuttle Avenue in Sarasota, Florida. As a result of matters discovered during a survey of the facility on August 5, 1998, the Agency changed the Emerald Oaks' license rating from standard to conditional. The conditional license was to expire on October 31, 1998. James Marrione was one of the surveyors who conducted the survey which resulted in the change in rating. The survey began on August 1, 1998. His examination of the records of various residents of the facility resulted in the discovery of several Class II deficiencies. One of the requirements placed upon a SNF is to develop policies to prevent the mistreatment of residents. Federal law mandates the establishment of a minimum data set of records (MDS) for each resident of an SNF. The MDS is to contain at least an assessment of the resident and a plan of care. When Mr. Marrione checked the MDS for Resident 4 on August 1, he found a current assessment had not been done. Resident Four: In addition to checking the MDS, Mr. Marrione also visited this resident and found the resident suffered bi-lateral contractions of the hands. This condition is usually caused by a neglectful failure to attend to the paralysis caused by a misuse or non-use of the hands. This is not a routine condition. On the day of Mr. Marrione's visit, he found the resident lying flat in bed in the same position from 2:00 to 4:00 p.m. Marrione checked on the resident every half hour during that period to see if the resident had been moved every two hours as the care plan called for, and to see if any of the resident's personal needs had been met. The resident was incapable of holding a cup from which to drink, and needed help. At first, Mr. Marrione did not check on the pad under the resident, but the resident said she was incontinent. As a result, at 4:15 p.m. on that day, Mr. Marrione asked for assistance and looked at the resident's buttocks. He found the resident's skin to be excoriated and the pad soaked with urine. Mr. Marrione also noted that the care plan called for the resident to be wearing booties to prevent damage to the skin of the heels, but none were present. Ms. Mitchell headed the unit where Resident 4 was housed, and she is sure that the resident regularly wore booties in bed and never developed pressure sores on her heels. She was evaluated at bath time and regularly in between, and if any skin deterioration was noted, the physician would be called. In addition, the resident was discussed regularly at team meetings. Notwithstanding these procedures in place, no evidence was presented to contradict Mr. Marrione's eye-witness recollection that when he saw the resident she did not have booties on, and that the resident developed a pressure sore after admission because of a lack of proper care. Resident Six: Mr. Marrione also visited with Resident 6 on August 4, 1998. When he entered the resident's room he smelled a strong odor of feces. He came back to this room every half hour, and each time, smelled the same odor. He determined that the resident had not been moved periodically as required. When he looked at the resident's bottom, he found it red and excoriated as well. Mr. Marrione again visited Resident 6 at 7:45 p.m. On this occasion he again noticed the odor of feces and when he checked the resident's buttocks, he found them still to be red and excoriated. He also noticed a stage 2 pressure sore on the buttocks right below the cheek, which had not been there on the previous visit. Mr. Marrione's review of the MDS relating to this resident dated April 29, 1998, showed that at that time the resident had no pressure sores. However, it was mentioned that the resident was incontinent of bowel and bladder. This is important because moisture from urine and feces contributes to skin breakdown, and the orders in the resident's file called for the resident to be kept dry and taken to the toilet frequently. A significant change to the resident's MDS on June 29, 1998 showed a stage 2 pressure sore had been identified, and on July 1, 1998, a physician ordered an antibiotic for the resident and that a cream be applied to the area to keep out moisture. Marrione's review of the records for this resident showed no skin assessments having been done thereafter except for one on July 27, 1998. In the interim, however, the care plan for Resident 6 dated July 7, 1998 revealed the existence of a condition leading to a pressure sore and directed action to prevent it. However, the resident's record shows that on July 27, 1998, stage 1 and stage 2 pressure sores were found. The records also contained doctor's orders to keep the resident's heels elevated, but when Mr. Marrione checked, he found the resident's heels were on the bed surface. Observations made on each of the survey days showed the resident had a stage 2 pressure sore on the buttocks, but there was no indication that this incontinent resident had been taken to the toilet frequently as the doctor had ordered. A pressure sore is a break in the skin and is classified as to severity from stages 1 through 4. The higher the number, the more severe the condition. A stage 2 pressure sore is only a break in the skin, However, it can lead to infection, can cause loss of protein, and is uncomfortable to the patient. If untreated, and if it progresses to stage 4, it can be very serious. To prevent pressure sores, it is necessary to keep the patient clean and dry and to turn the resident every two hours. Not all pressure sores are avoidable, however. Regardless of how good the care given is, some pressure sores will develop on some patients. In that regard, Resident 6 was an extremely sick resident with physical conditions which contributed to the development of pressure sores. Mr. Marrione admits this resident was very difficult to manage. He was quarrelsome, non-compliant, uncooperative, and argumentative, and these factors contributed to the development of his pressure sores. The resident's physician, Dr. Harris, indicated in a handwritten note dated August 12, 1998, that the staff's attention to the resident's hygiene had been "quite adequate" in maintaining the resident's quality of life and health. Ms. Mitchell, the facility's former unit manager, knew Resident 6 from another nursing home. She recalls that he had numerous health problems and his general skin integrity was very fragile. She remembers him as being very uncooperative. He would refuse meals and refuse to take nutritional supplements. He was offered any food he wanted, but he still resisted eating, even though a nutritional assessment indicated dietary problems. The resident also had numerous circulatory problems and was incontinent of bowel and bladder. Nonetheless, he refused urinals and resisted going to the bathroom, voiding in his bed instead. As a result, he was identified as a risk for pressure sores, and was referred for evaluation to the trans-disciplinary team (TDT) which recommended repositioning, creaming of the skin, hydration, washing and cleaning the body, and, because he could turn himself in bed to some degree, the use of bed-side rails to allow him to turn himself more easily. All of the recommendations of the TDT were regularly offered to Resident 6, but due to his lack of compliance, often they could not be implemented. The resident refused to use the call button available to him, and when a pillow was placed under his feet to keep them off the bed, he would pull it out. Notwithstanding the resident's total lack of cooperation, staff remained available to help in any way possible and no service was denied him. He was placed on regular incontinent care status which called for him to be taken to void himself no less than every two hours, and if he was seen to be soiled before then, he was cleaned. He did not have to wait until the next toilet run. In addition, the staff got the resident's son involved in an effort to encourage him to cooperate, but nothing they did worked. Ms. Mitchell is confident that the care given Resident 6 in general was excellent, not only at the time of the survey, but at all times. In her considered opinion, given his medical condition, his pressure sores were unavoidable. In light of the evidence presented regarding Resident 6, it cannot be found that the facility's staff acted in an inappropriate manner, and the resident's condition is deemed to be the result of his physical condition and lack of cooperation, and not as a result of any failure on the part of the facility or its staff. Resident Fifteen: Marrione's review of the records relating to Resident 15 revealed physician orders dated October 23, 1997, which called for the resident to wear booties. When Marrione looked at this resident on August 5, 1998, he discovered that the resident was not wearing booties as ordered. He does not know if the resident was provided with booties on other days of the survey. The booties referenced are padded and are worn by the resident to prevent skin breakdown. Ms. Weyant recalls, as to Resident 15, that she regularly and routinely had and wore in bed the booties called for by the physician's orders in the file, with some exceptions. In Weyant's opinion, the occasional failure to ensure booties were worn by the resident had no adverse effect of the resident's skin condition. This resident was regularly observed and her skin evaluated on a daily basis. Ms. Weyant cannot recall seeing any pressure sores on the resident's heels at any time. Resident Sixteen: Review of the records of Resident 16 showed that on July 6, 1998, when admitted to the facility, the resident showed no indication of pressure sores. The resident was identified as incontinent of bladder and at risk for skin breakdown. The care plan called for action to assist the resident and included mobility and toileting. Nurses' notes for July 28, 1998 showed two pressure sores had developed. Pressure sores are a constant threat to bedridden patients. However, there are preventive measures which can be taken to reduce the risk that a patient will develop them. These include following prescribed protocols set out in the MDS and assessments; turning and repositioning the patient on a frequent and regular basis; keeping the patient clean and dry; ensuring the patient gets proper nutrition; and cushioning the likely areas of abrasion. As to the turning and repositioning, as a general rule, two hours between turnings is appropriate. Resident Two: Ms. O'Connell, the Agency's other nurse surveyor on this survey, reviewed Resident 2, a patient initially admitted to the facility with a fracture of the femur and lung disease. These conditions resulted in restricted movement. Her review of the MDS disclosed that the resident had a stage 1 (healed) pressure sore and a stage 2 (pink) pressure sore upon admission which had developed into a stage 3 pressure sore on May 28, 1998, fifteen days later. This resident wore a brace on her leg which restricted her mobility and increased the need of the staff to help her with her mobility. When the pressure sores were discovered, an interdisciplinary care plan was formulated to deal with them. This plan included repositioning the resident every two hours. The resident was observed by the surveyors at least once each shift on each of the three days of the survey. The surveyors reported that each time she was looked at, at least nine times, the resident was seen to be lying on her back. This indicated to Ms. O'Connell that the resident was not being turned properly. Ms. O'Connell cannot be sure if she, or any of the other surveyors, actually saw the pressure sores on this resident. According to Ms. Weyant, the registered nurse unit supervisor of the unit in issue here, Resident 2, whose primary diagnoses on admission were a fractured femur and lung disease, also suffered from congestive heart failure and other complications. When, several weeks after her admission, staff noticed the stage 2 and stage 3 pressure sores which had not been there upon admission, they continued to monitor the condition. In June, the resident's physician said the leg brace could come off while the resident was in bed, and in July 1998 she was allowed to have it off even when out of bed. By that time, the pressure sores had improved to stage 2 and by the end of July they were at stage 1 and were considered healed soon thereafter. However, Ms. O'Connell also noted that when she saw the resident on August 5, 1998, the resident was sitting, exposed, on the bed pan, with no covers concealing her except on her feet. The resident subsequently left the facility to return to the adult living facility where she had lived before coming to Emerald Oaks. In the opinion of Ms. Weyant, a unit manager at the facility, Resident 2 had poor circulation which is a contributing factor to the formation of pressure sores. So was the pain she experienced from her fracture which reduced her mobility. The resident also was not a co-operative patient, Ms. Weyant recalls. She would refuse to change position or to get out of bed even though the staff explained to her that it would be in her best interests to do so. The resident was competent and, therefore, could refuse treatment. Though Ms. Weyant claims a notation to this effect is in the resident's records, no direct evidence of this was presented by either side. Regardless, even when a resident is uncooperative, according to Ms. Weyant, the staff continues to try interventions such as repositioning. Though she is sure this was done in this case, she cannot be sure it was documented. Nonetheless, as the resident's leg healed, she became more mobile and her pressure sore healed more rapidly. As her leg healed, she was in less pain and became more cooperative. This resulted in faster healing. Ms. Weyant cannot conceive of what more could have been done to prevent pressure sores from developing on this resident than was done. Under the circumstances of that case, she considers it to have been almost unavoidable. However, without adequate documentation in the medical records, in light of the survey observations, it cannot be found that the resident was properly moved or repositioned as required. As a result of this survey, the deficiencies identified were classified as Class II deficiencies which, under Florida law, automatically results in the issuance of a conditional certificate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health care Administration enter a final order confirming the issuance of a conditional license to Emerald Oaks, effective August 5, 1998. DONE AND ENTERED this 23rd day of September, 1999, in Tallahassee, Leon County, Florida. ARNOLD H. POLLOCK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6947 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 1999. COPIES FURNISHED: Jay Adams, Esquire Broad and Cassel 215 South Monroe Street Suite 400 Post office Drawer 11300 Tallahassee, Florida 32302 Karel L. Baarslag, Esquire Agency for Health Care Administration 2295 Victoria Avenue Fort Myers, Florida 33901 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3 Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration Fort Knox Building 3 Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308
The Issue An Administrative Complaint dated February 2, 1998, alleges that Respondent, Dennis Gross, M.D., violated Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. More specifically the Administrative Complaint alleges that Dr. Gross failed to properly diagnose and treat a 20-month old patient on August 8, 1994, which patient expired that same day.
Findings Of Fact Dennis Gross, M.D., is now and since December 31, 1973, has been licensed as a medical doctor in the state of Florida with license no. ME0021286. Dr. Gross is board-certified in pediatrics. He has had an active, private general pediatric practice in central Florida for the last 22 years, seeing an average of 30-35 patients a day. His practice consists of well child care, routine visits, physicals, and immunizations, but also includes acute care, illnesses, and injuries. His office hours are Monday through Friday and a half-day on Saturday; he routinely takes calls from his patients' parents and does not rely on his nurses to handle those calls. He also sees patients at night or on weekends at the hospital, but generally if a patient is critically ill and requires in-hospital care, he calls for a consult from a pediatric intensivist, a sub-specialty of pediatric care for critically ill children. Dr. Gross was the pediatrician for the M. family for about 12 years. R.M., a male child was born on November 18, 1992, and Dr. Gross began treating him from birth. During the course of his treatment of R.M., Dr. Gross learned that the child had a rare immunodeficiency syndrome, cyclic neutropenia, characterized by cyclical (generally 14-45 days) reduction in the patient's neutrophils (the most prevelant type of white blood cells.) R.M.'s father and older half-sibling also had this condition. When the patient's neutrophils are low, bacterial infections occur. In the infant R.M. such infections occured frequently. Between his birth and August 1994, Dr. Gross treated R.M. for various infections on approximately 24 occasions. These included boils and abcesses, infected rashes and other infections primarily localized on the skin. R.M. was also treated for normal childhood illnesses such as coughs, colds, and ear infections. On each occasion Dr. Gross was able to quickly identify the problem and treated it appropriately. For approximately 22 months R.M. thrived and achieved age-appropriate growth and developmental levels. On August 8, 1994, between 9:00 a.m. and 9:30 a.m., R.M.'s mother called Dr. Gross at his office and told him that R.M. had a low-grade fever and had vomited through the night. She said he had not vomited, however, within the 4 to 5 hours. Dr. Gross told the parent to put R.M. on clear liquids, to call back if the vomiting persisted, and to check back the following day anyway because of the child's history. Although the mother was aware of Dr. Gross' practice of seeing patients the same day on request she did not make such a request at that time. Instead, R.M.'s father, a school principal, stayed home with him in the morning and brought him to school to the mother, a teacher, in the later morning. R.M.'s mother took him home and apparently called Dr. Gross' office for a same-day appointment because she appeared with R.M. at the pediatrician's office around 3:30-4:00 p.m. When Dr. Gross entered the examining room, R.M. was walking around the room. Dr. Gross placed him on the examining table and observed an "alert and active child." His mouth appeared slightly dry and with the exception of increased bowel sounds and a rectal temperature of 104.1?, all other signs were normal. Dr. Gross told the mother that he felt R.M. had gastroenteritis, a viral infection, and told her he didn't want the child to dehydrate. He administered a shot of antiemetic and R.M. howled, a thoroughly normal reaction. Dr. Gross also prescribed Phenergan suppositories and told the mother to keep him on clear liquids slowly and call back if necessary. The child walked out of the office with his mother. Approximately 45 minutes later at home R.M. stopped breathing and was taken to the hospital. Dr. Gross was called to the hospital where CPR, epinephrine and other emergency measures were employed to attempt to revive the child. He was pronounced dead at 6:25 p.m. The autopsy determined that the cause of death was "septicemia, due to complications of cyclic neutropenia." More specifically, bacteriology studies revealed three species of clostridium, including clostridium septicum identified in the blood culture. (Petitioner's Exhibit No. 4, p. 5/83) The Standard Of Care The foregoing facts are substantially uncontroverted. The parties' dispute is whether Dr. Gross' diagnosis of R.M. on August 8, 1994, constituted failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. On this issue, the experts are at odds. Petitioner's sole witness was Dr. Lucian DeNicola, a professor of pediatrics in pediatric critical care medicine at the University of Florida Health Science Center in Jacksonville, Florida. Dr. DeNicola's opinion formed the basis for the Administrative Complaint in this case. Dr. DeNicola is board-certified in pediatrics and in pediatric critical care. With outstanding education and experience Dr. DeNicola has, nonetheless, very limited experience in an active outpatient general pediatrics practice such as Dr. Gross' practice. That practice was for 6 years at an outpatient clinic operated by the University of Massachusetts and that experience ceased approximately 16 years ago. Dr. DeNicola is an intensivist, specializing in the care of critically ill children. Based on R.M.'s history and the elevated temperature, Dr. DeNicola's opinion is that Dr. Gross should have suspected something serious, should have taken or ordered a blood culture, and should have immediately administered a broad spectrum antibiotic. Clostridia infections are virulent and highly toxic, but they are killed with antibiotics, usually a penicillin. Dr. DeNicola's opinion was considered and weighed in this proceeding but has been rejected in favor of the more relevant and, under the circumstances of this case, more credible, opinions of Respondent's witnesses. Dr. Raymond Caron is board-certified in pediatrics and has practiced in Orlando, Florida, for approximately ten years. A sole-practitioner like Dr. Gross, he sees children from birth through adolescence, providing a mix of routine well-child care and acute care. Dr. Cody Meissner's training and experience is closely analogous to that of Dr. DeNicola. That is, he practices medicine in a teaching hospital setting, through the Tuft's University School of Medicine in Boston, Massachusetts. Dr. Meissner is head of the Pediatric Infectious Disease Division at the New England Medical Center. He teaches, directs research, consults with pediatricians throughout New England, and spends several hours a day with patients in the hospital or emergency room. Dr. Meissner is board-certified in pediatrics and in pediatric infectious diseases. There are viral infections and bacterial infections. Viral infections do not respond to antibiotics and administering antibiotics indiscriminately is contraindicated and can be very detrimental. The indiscriminate use of antibiotics can create drug-resistent strains of infections and the antibiotics may ruin an outcome of subsequent blood cultures which are supposed to identify the potential bacteria. Dr. Gross did not have an in-office capacity to perform a blood culture nor did most his colleagues in private pediatric practice have that capacity. The standard of care did not require that capacity. Even a culture taken in an emergency room setting would have meant a several-hour delay between the time R.M. was seen by Dr. Gross and the results of the culture. In the meantime, the injection of an antibiotic by Dr. Gross would likely have masked the result of the culture and would have produced a false negative. More significantly, and even with Dr. Gross' foreknowledge of R.M.'s propensity for infections, nothing specifically in the child's condition on the afternoon of August 8, 1994, clued the pediatrician to the fact that the child was already full of deadly toxins. Bacterial infections, in contrast with viral infections, are generally identified with a focus of the infection: lesions, draining, inflammation, tenderness or localized pain or swelling. Impending septicemia typically is manifested by lethargy, limpness, cyanosis (paleness), low blood pressure, an inability to make eye contact, and severe irritability. R.M. presented none of these signs to Dr. Gross. R.M.'s very normal reaction to the injection would not be typically found in a child as sick as he truly was. Young children with temperatures of 104? are not extraordinary. Pediatricians in an active practice like Dr. Gross' may see several such patients daily, or weekly, depending on the season. Dr. Gross' diagnosis of gastroenteritis was consistent with his observations, examination and knowledge of the child's history. According to Dr. DeNicola, R.M. could have had an interferring viral infection that caused the earlier vomiting that set up the bacteremia. (deposition, p. no. 66) In summary, the standard of care as more credibly described by Respondent's witnesses did not require that Dr. Gross perform or order a blood culture or administer an antibiotic to R.M. on the afternoon of August 8, 1994.
Recommendation Based on the foregoing, it is hereby RECOMMENDED: that the Board of Medicine issue a Final Order dismissing the Administrative Complaint at issue. DONE AND ENTERED this 8th day of December, 1998, in Tallahassee, Leon County, Florida. MARY CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 8th day of December, 1998. COPIES FURNISHED: Carol A. Lanfri, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Martin B. Unger, Esquire Unger, Swartwood, Latham & Indest, P.A. Post Office Box 4909 Orlando, Florida 32802-4909 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela Hall, Agency Clerk Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact The Petitioner, St. Jude Manor Nursing Home, is a skilled nursing facility within the meaning of Title XIX of the Social Security Act. In the past, and as recently as October 14, 1976, the Petitioner has received permission for a variance in its seven-bed ward which exceeds the number of beds per ward specified by Section 405.1134(e), Code of Federal Regulations (CFR). The most recent permission for variance has been received from the State of Florida, Department of Health and Rehabilitative Services. The terms and conditions of that variance may be found in Petitioner's Exhibit No. 2 admitted into evidence. In particular, that variance was allowed with the proviso that as patients whose needs justified the type of occupancy in excess of the limit were discharged, the seven-bed ward would be reduced to four beds to achieve compliance with the terms of the Code of Federal Regulations. It was further indicated in the statement of permission that the Respondent expected the reduction to be completed by November 30, 1977. The variance of October 14, 1976, came about after an inspection had been performed by the Respondent at the Petitioner's facility. Following that inspection a statement of deficiencies and plan of correction was made and one of the items, which is the sole item in dispute at this time, dealt with the seven-bed-ward. Out of the August 16-18, 1977, inspection performed by the Respondent, a request for waiver was made by the Petitioner that led to the permission found in the October 14, 1976, letter by the Respondent. (The statement of deficiencies and plan of correction which indicates this request may be found as Hearing Officer's Exhibit No. 1 admitted into evidence.) One of the items in support of the request for variance was a letter from Richard J. Wilhelm, M.D., which spoke to the criteria found in Section 405.1134(e), Code of Federal Regulations (CFR), and apparently this explanation and reason for requesting a variance was persuasive, due to the subsequent grant of the variance. (Dr. Wilhelm's letter may be found as Petitioner's Exhibit 3 admitted into evidence for limited purposes as set forth in the transcript of the hearing.) It is not abundantly clear what transpired beyond the suspension date of the variance; however, the action of the parties beyond that time has led to the current hearing. In essence what has occurred is the fact that the Respondent has taken the position that no further variance may be granted beyond the period of the normal attrition of the three extra patients in the seven-bed ward, which patients were in excess of the four patients allowed in any given room under the terms of the aforementioned Code of Federal Regulations. The Respondent has come the conclusion that no further variance may be granted, premised upon its understanding that it is required to operate within the dictates and requirements and interpretations of the Code of Federal Regulations which have been placed by employees within the United States, Department of Health, Education and Welfare. The Respondent has come to this conclusion after receiving a January 30, 1976 communication from John E. Pipes, Director of the Office of Long Term Care Standards Enforcement, Region IV, United States, Department of Health, Education and Welfare, Atlanta, Georgia. A copy of this letter may be found as Respondent's Exhibit No. 1 admitted into evidence. Within the body of that correspondence Mr. Pipes states that Section 405.1134(e), Code of Federal Regulations (CFR), will only allow a variance to last for as long as the needs of the affected patients justify. Subsequent to that correspondence, officials with the Respondent wrote to Mr. Pipes on March 4, 1976, to try to clarify the status of those nursing homes in the state of Florida which had wards with more than four beds per room, and to try to emphasize to Mr. Pipes the potential loss of beds if the opinion of Mr. Pipes was allowed to go forth on the question of not allowing variances after the first attrition of the patients who were housed in the excess beds. (The full details of the March 4, 1976 letter may be found in a copy of that letter which is Respondent's Exhibit No. 3 admitted into evidence. On April 1, 1976, Mr. Pipes responded to the March 4, 1976 letter and refused to change his position on the question of the variance letter. Henceforward, the Respondent has taken the position that Mr. Pipes' opinion of the meaning of Section 405.1134(e), Code of Federal Regulations (CFR), is dispositive of that issue and the Respondent, as the agent for the State of Florida; in the Respondent's opinion, may not use its independent judgment in determining whether a variance may be granted to a facility with more than four beds in a ward. The position taken by the Respondent is contrary both to the language of Section 405.1134(e), Code of Federal Regulations (CFR), and the terms of the State Plan for Medical Assistance, under Title XIX of the Social Security Act, Revision MSA-PI-75-3 August 20, 1974. This conclusion is reached due to the unequivocal statement found within the referenced section of the Code and the written agreement by the State of Florida to take the responsibility for making determinations under the Code of Federal Regulations in matters pertaining to Title XIX of the Social Security Act, without the necessity of the permission of the United States, Department of Health, Education and Welfare or its officials. The efficacy of this conclusion may be seen by a reading of the portion of Section 405.1134(e), Code of Federal Regulations (CFR), which states: * * * "The Secretary (or in the case of a facility participating as a skilled nursing facility under Title XIX only, the survey agency - See Section 249.33(a)(1)(i) of this title) may permit variations in individual cases where the facility demonstrates in writing that such variations are in accordance with the particular needs of the patients and will not adversely affect their health and safety. Each room is equipped with or is conveniently located near, adequate toilet and bathing facilities. Each room has direct access to a corridor and outside exposure, with the floor at or above grade level. The Petitioner is a facility participating as a skilled nursing facility under Title XIX and the State of Florida, Department of Health and Rehabilitative Services, under the terms of its contract with the United States, Department of Health, Education and Welfare, is the surveying agency, within the meaning of the above referenced provision. Moreover, when this is considered in conjunction with the terms and conditions of that contract, the only reasonable interpretation to be given this matter is that the Respondent not only has the power but has the duty to make determinations on various requests make by those skilled nursing facilities operating under Title XIX only, which are found in the state of Florida. (The after-filed exhibit which is the State Plan for Medical Assistance, under Title XIX of the Social Security Act, Revision MSA-PI- 75-3 August 20, 1974, is hereby made Hearing Officer's Exhibit No. 2 admitted into evidence.) Having resolved this issue in favor of the Petitioner, the question then becomes whether or not the Petitioner has sufficiently demonstrated a right to a variance on the merits of his claim as tendered at the time of the hearing. The principle witness in behalf of the Petitioner who appeared at the hearing for purposes of speaking to the substance of the request was Richard Wilhelm, M.D. Dr. Wilhelm attends the patients in the seven-patient ward and feels that the care that those patients are receiving in the seven-patient ward is equal to the care received by others in the four-patient or less wards. He felt that psychologically the patients in the seven-patient ward are progressing as well as patients in the other rooms and some patients who have been in the seven- patient ward have progressed to the point of being sent to intermediate care or home care. Overall, he is extremely impressed with the care and to cutback the number of beds from seven to four would not help the quality of that care. At present, according to Dr. Wilhelm, none of the original patients who were in the seven-bed ward at the time of the variance being granted in October, 1976, are still in that ward. This is born out by Petitioner's Exhibit No. 6 admitted into evidence, which Is a list of admissions in the seven-patient ward, beginning in August, 1976. through January 11, 1978. C. M. Knight, the Petitioner's administrator, testified at the hearing to the effect that there is more staff participation in the seven-patient ward than in other patient rooms. He also indicated that the patients who were in semiprivate rooms and were subsequently moved to the seven-bed ward have improved. He further stated that patients who had been in the seven-bed ward and been moved to other wards had requested to return to the seven-bed ward. Mr. Knight also expressed some concern that removal of the three beds would hurt the ability of the city of Jacksonville, Florida to respond to the needs for skilled nursing care. He had no particular basis for this conclusion, but it does seem consistent with the fears expressed by Joseph C. Thompson, Acting Chief of the Bureau of Health Facilities, State of Florida, Department of Health and Rehabilitative Services, in his March 4, 1976, correspondence to Mr. Pipes, which is Respondent's Exhibit No. 3. As may be recalled, this letter indicated that at that time 144 beds were feared to be lost by a reduction of beds in the wards with more than four patients. After full consideration of the testimony offered by the Petitioner on the question of a variance, it must be concluded that the variance should be rejected at this time, due to the failure of the Petitioner to sufficiently address the issue of safety, adequate toilet and bathing facilities, and access to the corridor and outside exposure, with floors at or above grade level, as required by Section 405.1134(e), Code of Federal Regulations (CFR). Should these areas of consideration be satisfactorily met, and should the excessive number of patients in the subject ward continue to be in accordance with the particular needs of the patients and not adversely affect their health; then the Respondent acting in its own discretion and not that of the United States Department of Health, Education and Welfare, may grant a variance on the number of patients in the seven-patient ward. Notwithstanding any decision on the request for variance by the Petitioner that may be made in the future, the undersigned is absolutely convinced that the Respondent may not arbitrarily refuse to consider the merits of the variance request based upon its interpretation of the Pipes' correspondence which has been referred to in the course of this Recommended Order.
Recommendation It is recommended that the Petitioner's request for variance under Section 405.1134(e), Code of Federal Regulations (CFR) be denied; however, future consideration of variance requests should be made when those requests are tendered and the request should be considered in keeping with the judgment of the Respondent, State of Florida, Department of Health and Rehabilitative Services. DONE and ENTERED this 26th day of May, 1978, In Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: C. M. Knight, Administrator St. Jude Manor Nursing Home 2802 Parental Home Road Jacksonville, Florida 32206 Robert A. Eisenberg, Esquire Department of HRS District IV Counsel Post Office Box 2417F Jacksonville, Florida 32231 Joseph Dowless, Jr., Director Leonard Schaeffer, Esquire Office of Licensure and Certification Suite 1300, 1845 Walnut Department of HRS Philadelphia, Pa. 19103 Post Office Box 210 Jacksonville, Florida 32201
The Issue Whether the Petitioner's licensure status should be reduced from standard to conditional effective April 5, 2001.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: AHCA is the state agency responsible for licensing and regulating the operation of nursing home facilities, including ensuring that nursing homes are in compliance with criteria established by Florida statute. Chapter 400, Part II, Florida Statutes (2000).1 Beverly Fort Pierce, located in Fort Pierce, Florida, is a facility licensed to operate as a nursing home pursuant to the provisions of Chapter 400, Part II, Florida Statutes, and the rules found in Chapter 59A-4, Florida Administrative Code. AHCA conducted an annual relicensure survey of Beverly Fort Pierce from April 2 through April 5, 2001, ("April 5, 2001, survey") for the purpose of determining Beverly Fort Pierce's compliance with the state and federal criteria applicable to nursing homes. As is AHCA's usual practice, the alleged deficiencies found during the survey were reported on a form used by the federal Department of Health and Human Services, Health Care Financing Administration, HCFA-2567, which is commonly referred to as a "Form 2567." The deficiencies cited on the Form 2567 were identified in accordance with the criteria set forth in the State Operations Manual, which is published by the federal Health Care Financing Agency and provides guidance to state surveyors in interpreting and applying the federal regulations applicable to nursing homes receiving reimbursement from Medicaid and/or Medicare. The State Operations Manual, Guidance to Surveyors, includes "tag numbers" corresponding to provisions of the regulations found in Title 42, Chapter 483, Code of Federal Regulations. In the State Operations Manual, a "tag number" is associated with each provision of the federal regulations, and the intent of the regulation is set forth, together with guidelines, procedures, and probes which are to be used by the state surveyors in determining whether a particular regulation has been violated. The deficiencies cited on the Form 2567 completed as a result of the April 5, 2001, survey of Beverly Fort Pierce were each identified by the federal tag number, by a citation to the applicable provision of the Code of Federal Regulations, by a citation to the applicable Florida administrative rule, and by a Florida statutory classification as either a Class II or Class III deficiency. The Form 2567 included citations for three Class II deficiencies and for several Class III deficiencies. On May 18, 2001, AHCA returned to Beverly Fort Pierce and conducted the first "revisit survey" subsequent to the April 5, 2001, survey. The Form 2567 prepared for the May 18, 2001, revisit survey indicated that two deficiencies from the April 5, 2001, survey remained out of compliance. In its original five-count Administrative Complaint, dated December 3, 2001, AHCA identified as the bases for the reduction of Beverly Fort Pierce's licensure status to conditional two of the three Class II deficiencies and one of the several Class III deficiencies cited in the Form 2567 for the April 5, 2001, survey, as well as the two Class III deficiencies cited in the Form 2567 for the May 18, 2001, revisit survey. The Amended Administrative Complaint filed on the date of the hearing contained only three counts, and, at the hearing, AHCA voluntarily dismissed two of the three counts in the Amended Administrative Complaint. Accordingly, at the hearing, AHCA offered proof only with respect to the Class II deficiency identified in the Form 2567 for the April 5, 2001, survey based on the allegations that resident #13 developed pressure sores on her right heel, left heel, and right great toe while she was a resident at Beverly Fort Pierce.2 At the time of the April 5, 2001, survey, resident #13 was 92 years of age and had resided at Beverly Fort Pierce since November 21, 1995. Resident #13 was chosen by the survey team prior to the commencement of the survey as one of the residents to be observed during the team's visit to Beverly Fort Pierce. During the initial tour of the facility on April 2, 2001, the survey team leader, Judy Spiritu, visited resident #13's room and noticed that she was lying on her back in bed and was wearing heel protectors, although the one on the left leg was around her calf. Ms. Spiritu decided to observe resident #13 more closely during the survey, and she reviewed her clinical records and interviewed her caregivers. The Nurses Notes for resident #13 indicate that "pressure areas to bilateral heels" were noted by the care specialist at approximately 10:30 p.m. on March 1, 2001, and the resident's feet were elevated off of the bed. At 10:00 a.m. on March 2, 2001, resident #13's right heel and great toe were sprayed and wrapped and socks and heel protectors were applied. At 1:00 p.m. on March 2, 2001, blisters were noted on resident #13's right and left heels and right great toe; the blister on the right heel measured 3 centimeters by 3 centimeters, the blister on the top of the right great toe measured 0.5 centimeters by 0.5 centimeters, and the blister on her left heel measured 1 centimeter by 1 centimeter. The blisters were classified as Stage II ulcers, defined in Beverly Fort Pierce's records as "an ulceration in which partial thickness of skin is lost with involvement of the epidermal and/or dermal layers of skin."3 Resident #13 suffered from a number of serious medical problems, including seizure disorder, advanced Alzheimer's disease, carotid artery stenosis, a duodenal ulcer, hypertension, osteoporosis, arthritis, peripheral vascular disease, arterial sclerotic heart disease, and aortic heart disease. The Minimum Data Set dated February 15, 2001,4 indicated, among other things, that resident #13 was completely dependent on staff for turning and repositioning in bed, although she could move her legs, and that resident #13 was incontinent of bowel and bladder. Beverly Fort Pierce prepared a Problem Summary for resident #13 based upon the problems identified in the Minimum Data Set prepared February 15, 2001. Entries made in the Problem Summary for resident #13 on February 16 and 22, 2001, reflect that, over the previous 90 days, resident #13 had significant weight loss and decline in functioning with respect to activities of daily living and that she was totally dependent on staff for bed mobility.5 It was also noted in the Problem Summary entry for February 22, 2001, that resident #13 was at risk for the development of pressure ulcers because of incontinence, advanced Alzheimer's, and the decline in bed mobility. Beverly Fort Pierce had in place a Plan of Care for resident #13 for February 2001, and it was noted in the February 22, 2001, entry that resident #13 was at risk of developing pressure ulcers due to incontinence; it was further noted that, at the time, she had no pressure ulcers. A number of interventions were identified in the Plan of Care to deal with the risk that resident #13 would develop pressure ulcers, including use of a "pressure relieving mattress"; "protective/preventative skin care after each incontinent episode"; "monitor skin turgor for any area of concern"; "[i]ntervene as needed"; and "turn and reposition Q 2H [each two hours]." There is no mention in resident #13's Plan of Care that heel protectors should be used as an intervention until on or after March 2, 2001, when the Stage II ulcers on resident #13's heels and right great toe were first discovered. Although there is no indication in the Plan of Care of the date on which a pressure-relieving mattress was provided, Beverly Fort Pierce replaced all of its mattresses with pressure relieving-mattresses several years prior to the times material to this proceeding. Skin Assessment Forms completed for resident #13 for March and April 2001 documented that resident #13's skin was assessed weekly from March 5, 2001, through April 16, 2001, and the existence of blisters on the right and left heels and the right great toe were noted on the March 5, 2001, assessment.6 In addition, the Treatment Records for March and April 2001 carry a set of initials for each shift for most days through April 22, 2001, beside the entry of an order dated February 16, 1999, which required the following care: "Both siderails up when in bed due to alteration in safety awareness due to cognitive decline. Check q [each] 30 min[.] Release q2h [each two hours] for positioning and tolieting [sic]."7 It was not the policy of Beverly Fort Pierce to make a notation each time routine care such as turning and repositioning was provided, and the only explicit indication that resident #13 was turned and repositioned was an entry in the Nurses Notes for March 23, 2001.8 The first mention of the use of heel protectors was a notation in the Nurses Notes entered at 10:00 a.m. on March 2, 2001, and the use of heel protectors for resident #13 is often mentioned in the Nurses Notes after that date. A pressure ulcer is a sore that develops as a result of pressure to areas of the body referred to as pressure points, because the pressure diminishes the blood supply to the affected area and results in the death of the tissue; a pressure sore can develop in a matter of hours and may first appear as a Stage II blister because the damage to the tissue may initially occur beneath the surface of the skin. A stasis ulcer is an ulcer that develops on the lower extremities, most commonly in the "inner aspect of the lower third of the leg" and on the "lateral aspect of the leg."9 A stasis ulcer is related to chronic venous disease that inhibits the flow of blood from an area or to extensive arterial disease that inhibits the delivery of blood, oxygen, and nutrition to an area; a stasis ulcer develops over a period of time, not in one or two days, and is characterized by thickening, redness, and changes in the skin referred to as stasis dermatitis. Stasis ulcers develop as a result of a resident's clinical condition and are considered unavoidable. Based on the description in the Nurses Notes of resident #13's ulcers when they were first discovered and given the short time during which the ulcers developed, the ulcers on resident #13's heels and right great toe were pressure ulcers, not stasis ulcers,10 although the ulcers could have been caused in part by resident #13's vascular status.11 As noted in the entry on the Problem Summary of February 22, 2001, resident #13's medical condition had deteriorated during the previous 90 days, she had a number of serious medical problems, and she was very near the end of her life. A person with such morbidity factors is more likely to develop pressure ulcers despite being provided with appropriate routine preventive care and medical services than are persons with fewer or less serious medical problems. Although resident #13's clinical condition might have placed her at risk of developing pressure ulcers, the evidence presented by Beverly Fort Pierce establishes that the staff was aware that resident #13 was at risk of developing pressure ulcers and that certain preventive measures were included in her Plan of Care as a result of this risk, including providing her with a pressure-relieving mattress and turning and repositioning her in bed once every two hours. However, no requirement was included in the Plan of Care that heel protectors were to be used when resident #13 was in bed. Beverly Fort Pierce presented no evidence with respect to the preventive care that was actually provided to resident #13 prior to 10:30 p.m. on the night of March 1, 2001, when the pressure areas on resident #13's heels were noted. The evidence establishes that resident #13 was provided with a pressure-relieving mattress, but there is no evidence that she was turned and repositioned every two hours or that she was provided with heel protectors prior to 10:00 a.m. on March 2, 2001.12 Without proof of the preventive care that the staff provided resident #13, Beverly Fort Pierce has failed to establish that the pressure ulcers on resident #13's heels and right great toe were unavoidable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order: Finding that Beverly Health and Rehabilitation Center, Fort Pierce, had a Class II deficiency at the time of the April 5, 2001, relicensure survey in that resident #13 developed pressure sores on her heels and right great toe that were not unavoidable; and Reducing the licensure status of Beverly Fort Pierce from standard to conditional, effective April 5, 2001, pursuant to Section 400.23(7)(b), Florida Statutes (2000). DONE AND ENTERED this 24th day of April, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 2002.
