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
Findings Of Fact Manuel Valazquez, a resident of the Respondent ACLF, was admitted to the facility on May 31, 1984, from Jackson Manor Nursing Home. When he was transferred from the nursing facility to the ACLF, Valazquez was in good physical condition except for the presence of one bedsore on his foot. Valazquez and his family had requested the transfer from the nursing home to the Respondent's facility because the Respondent was a friend of the Valazquez family and Valazquez was not happy at the nursing home. During the course of his stay at the Respondent's facility, Valazquez's condition deterioriated due to numerous bedsores. While at the Respondent's facility, Valazquez received a total of seven treatments for these bedsores, the last of which occurred on June 25, 1984. On August 10, 1984, Valazquez was transferred to Snapper Creek Nursing Home with approximately ten bedsores over his body. Additionally, Valazquez was extremely thin, experienced muscle atrophy and organic brain syndrome with senile dementia. Following his admission to Snapper Creek, Valazquez died on August 14, 1984, of septicemia as a result of malnutrition and the presence of numerous advanced bedsores. While at the Respondent's facility, Valazquez did not receive proper care for his life-threatening condition in that he was kept in a hot room on plastic sheets and was not turned to relieve the body pressure which causes bedsores and keeps them from healing. Although the room in which Valazquez was kept had an air conditioner, it was not turned on by the Molinas because Valazquez did not request it. It is unreasonable, however, to expect an elderly man suffering from organic brain syndrome and dementia with serious medical problems to make such a request. Instead, the Respondents should have known that the heat of midsummer combined with his existing bedsores mandated that Valazquez be kept cool and comfortable. Valazquez should not have been admitted to the Respondent's ACLF when he had any bedsores and once these bed- sores began to multiply on his body, Valazquez should have immediately been transferred to a skilled nursing facility. In failing to take appropriate steps to remove Valazquez from his facility as soon as the bedsores began to develop and in keeping him in a hot room on plastic sheets, the Respondent acted in a negligent manner which seriously affected the health, safety and welfare of Manuel Valazquez.
Findings Of Fact During the period August 26-28, 1985, James L. Myrah, a hospital consultant for DHRS, accompanied by Ms. Christine Denson, a registered nurse, and other consultants in various disciplines from the Petitioner's office of licensure and certification, conducted a licensure, medicare, medicaid and civil rights survey at the Respondent's facility in Ft. Walton Beach, Florida. During the course of this survey, Mr. Myrah followed the normal procedure for such inquiries which included an entrance conference with the administrator, and a survey process which includes looking at various items for as many days as is required to do a thorough job.1 As a part of the survey, the team looks at every resident physically but examines patient charts on the basis of a random sample. In the instant case, examination of the patient records kept by the Respondent revealed only one variance. That was brought to the attention of the Petitioner's Office of Licensure and Certification by the Local District I omebudsman who commented about a particular patient, whose name will not be recited to preserve patient confidentiality, but whose initials, M.C., will be used as identification. By the time the survey was conducted, M.C. had already been transferred to another nursing home and was not physically present. Therefore, the inspection team was unable to examine her. However, they did examine her medical records and chart closely. This examination resulted in Petitioner drawing the conclusion that Respondent was in violation of the require ment for notification to the patient's physician whenever there is a substantial significant change in the patient's condition. The patient's chart was not entered into evidence. The report form identifying the deficiency (HRS Form 553E) was prepared by the inspection team based on its evaluation of the patient records. This was not objected to by Respondent, and in the absence of any objection to its entry, it was accepted. The entry for the 11 p.m. to 7 a.m. shift on May 22, 1985, reflects,2 "Total care given, nothing per os (by mouth) past midnight. Dr.'s appointment in am--resident seems very listless not talking as usual. Several small bruises noted on lower extremities (rt.) foot very discolored." This entry is, in the opinion of Ms. Denson, important because it relates to the fact that the patient was to go to the doctor in the morning. The use of the term "listless" might indicate a serious medical condition and a change of condition which should have been reported to the person next in charge. The term, "not talking as usual" shows a change that would require comment. In addition, the comment regarding the discoloration of the foot should have been reported to someone and not allowed to remain uncommented on until the visit with the doctor the next morning. The patient saw her physician, Dr. Wilson, at 8 a.m. on May 22, 1985; and returned to the home at 10 a.m. the same morning. Apparently nothing was considered to be wrong with the patient because no prescription for medicine or other treatment was given by the physician who, three days later, on May 25, 1985; when advised by nurses on the 7 a.m. to 3 p.m. shift of large black and blue areas on the patient's inner groin area, indicated he examined the patient and found nothing new clinically on May 22. There are repeated instances of comments which Petitioner alleges were not properly reported to the physician. For example, on May 23, personnel on the 11 p.m. to 7 a.m. shift reflected that the patient "continues to be listless. Right leg turned at a funny angle. Report to D.O.N. (Director of Nursing)." The 7 a.m. to 3 p.m. shift the following morning reported, "Both legs ecchymosis (discolored), hip moves oddly, color pale." The 3 p.m. to 11 p.m. shift the same day reported, "Color remains pale-- unusual movement and rotation of both legs noted." Additional comments of a similar nature were noted by personnel on the 11 p.m. to 7 a.m. shift on May 24 the 3 p.m. to 11 p.m. shift on May 24; and the 11 p.m. to 7 a.m. shift which discovered the discoloration to the pelvis as reported previously. At 4 p.m. on May 25, 1985, personnel reported their concern in reference to the bruises on the patient's groin and lower extremities to the physician and further entries show that at 5:10 p.m., the patient was subsequently returned to the home at 7:30 p.m. after x-rays were accomplished which failed to reveal any fracture. Nonetheless, because of continued concern by the nursing staff and at the urging of family members, the patient was returned to the hospital at 10 a.m. on May 27, 1985. At this point, she was found to have fractures of both lower extremities and upon release from the hospital was transferred to another convalescent center. Mrs. McCasland contends that all due care and concern was given to the patient, M.C., consistent with the long standing convalescent center policy governing changes in patient status. This policy statement, dated March, 1975, which is still in effect, requires that "in the event of a significant change in the patient's physical, mental, or emotional status, the attending physician is immediately called by the charge nurse." As was stated in paragraph 3, above, on May 22, an 11 p.m. to 7 a.m.'s shift nurse noted a small bruise on the left foot of the patient and that the patient was listless. Small bruises are not necessarily significant in geriatric patients (M.C. was 88 years old). Also, often older people do not talk for several days. In any event, the lack of any significant condition was confirmed by the physician who found nothing unusual in the patient's condition during the examination. The doctor's report reflects, inter alia, "physical examination is remarkable for an elderly white female in an involuted state appearing her stated age." Her extremities "show some area of bruising primarily in the upper thighs presumably related to lifting the patient. She has crepitance in the bilateral knees and is unable to fully extend her lower extremities." Neurologically; she was determined to be alert and the physician recommended continuing general support of care. On May 25, 1985, the charge nurse called Ms. McCasland at home indicating that the patient's legs seemed to be getting bluer. Ms. McCasland, at that moment, told the nurse to call the patient's physician which was done and the doctor indicated at that time that when he had examined the patient several days previously, he found nothing wrong. It apparently was the decision of the doctor to take no further action at that time. However, at approximately 4 p.m.; after the conversation with the physician; the charge nurse contacted the physician again, indicating she thought the patient needed to be x-rayed. At 5:10 p.m.; the patient was taken to the hospital; apparently at the order of the physician; for x-rays which showed no fractures. Nonetheless; this action would not have been taken were it not for the attention of the nurse on duty and actions of the Respondent's administrator. On the following day, May 26, the charge nurse from the 7 a.m. to 3 p.m. shift again called Mrs. McCasland at home and stated that the patient's legs were; "bad." Ms. MeCasland told the nurse to call the patient's physician who directed she be sent to the hospital for x- rays. The hospital would not accept the patient and as a result, the physician came to the convalescent center where he examined her and concluded that there was, in fact, a problem. He directed she be sent to the hospital the following day and when she was x-rayed then; fractures were discovered. It should be noted here that again the contact with the physician which resulted in the ultimate diagnosis of leg fractures, was initiated by the charge nurse at Respondent's center and communicated to the physician and Ms. McCasland by center personnel.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that deficiency number NH77(g); relating to the visit to Respondent's convalescent center on August 28, 1985, be removed. DONE and ORDERED this 7th day of May, 1986, in Tallahassee, Florida. _ ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of May, 1986.
Findings Of Fact Mark Hegedus, Respondent, is registered with the Florida State Board of Nursing and holds license No. 85729-2. He worked at the Sarasota Memorial Hospital (SMH) for approximately three years immediately preceding May 15, 1978. During the period between April 1, 1978 and May 15, 1978 Respondent was working on the cancer ward at SMH and was Charge Team Leader at the hospital. An audit conducted of the narcotics and barbiturates administration records at SMH for the period 1 April through 15 May 1978 disclosed that of 14 patients records selected who had been administered Demerol by Respondent, evidence of irregularity was discovered in 30 entries on 9 of the 14 patient medical records audited. These errors included signing out for 50 mg ampules of Demerol 11 times, for 75 mg ampules 11 times, and for 100 mg ampules 8 times in the narcotic record with no entry made on the Nurses Notes or on Medication and Treatment record. These errors involved patients Daryl C. Iverson, Edna Jurgenson, Clinton Jelmberg, John Lally, Genevieve Belt, Arleigh Updike, Michael Wujtowicz, Joan Slater, and Arda Miller. Hospital procedures and accepted nursing practice require the nurse administering narcotics to sign for the narcotic when it is removed from the narcotics locker and then make an entry in the Nurse Notes and patient Medication and Treatment record when the narcotic is administered to the patient. Medication and Treatment records are used by the doctors to see how frequently patients need narcotics prescribed on an as needed basis, whether the drugs prescribed have been administered, and by other medical personnel to ascertain when the patient last received and how much medication so as to preclude giving the patient an overdose. Respondent was discharged from his position at the hospital on 15 May 1978 because of the narcotics irregularities. At the time of his discharge, Respondent acknowledged that he had taken Demerol and had disposed of the ampules but that he did not use them himself or sell them. The audit disclosed a few errors in charting narcotics were committed by other nurses as well as Respondent. During the three years Respondent worked at SMH and, up until about 1 April 1978, he was a capable and competent registered nurse, well-liked by both patients and co-workers. He was promoted to First Team Leader after about one year at SMH and to Charge Team Leader approximately one year thereafter. These promotions were more rapid than the time required by the average nurse. All witnesses who had worked with Respondent spoke highly of his qualifications and dedication as a registered nurse.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 10th day of February, 2000.
