STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
AGENCY FOR HEALTH CARE ADMINISTRATION,
Petitioner,
vs.
EASTBROOKE HEALTH CARE ASSOCIATES, LLC, d/b/a HERON POINTE HEALTH AND REHABILITATION,
Respondent.
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) Case No. 03-0164
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RECOMMENDED ORDER
Pursuant to appropriate notice, this cause came on for formal proceeding and hearing before P. Michael Ruff, duly- designated Administrative Law Judge of the Division of Administrative Hearings on December 16, 2003, in Brooksville, Florida. The appearances were as follows:
APPEARANCES
For Petitioner: Michael O. Mathis, Esquire
Agency for Health Care Administration Fort Knox Building III, Suite 3431 2727 Mahan Drive
Tallahassee, Florida 32308
Gerald L. Pickett, Esquire
Agency for Health Care Administration Sebring Building, Suite 330K
525 Mirror Lake Drive, North St. Petersburg, Florida 33701
For Respondent: Donna Holshouser Stinson, Esquire
Broad and Cassel
215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300
R. Davis Thomas, Jr., Esquire Broad and Cassel
215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300
STATEMENT OF THE ISSUES
The issues to be resolved in this proceeding concern whether the Respondent violated the statutes and regulations cited in the Second Amended Administrative Complaint and referenced in this Recommended Order at the time of a survey for compliance conducted on October 1 and 2, 2002. If any of the charged violations occurred, it must be determined whether an administrative fine should be imposed, and, if so, in what amount. It must also be determined whether Heron Pointe should be subjected to the imposition of a conditional licensure status as a result of any proven violations.
PRELIMINARY STATEMENT
This cause arose as the result of a compliance survey conducted on October 1 and 2, 2002, by the Petitioner agency, instigated by the reported death of a resident. An Administrative Complaint was filed dated December 6, 2002, and later, after the filing and adjudication of motions to dismiss, an Amended Administrative Complaint was filed, and, ultimately,
a Second Amended Administrative Complaint dated November 10, 2003, upon which the cause proceeded to hearing. The Petitioner, in essence, alleges that the Respondent (Heron Pointe), as to Count I, violated Sections 400.23(8)(a) and 400.022(1)(o), Florida Statutes, and 42 C.F.R. Section 483.13(a); as to Count II, violated Section 400.23(8)(a), Florida Statutes, and 42 C.F.R. Section 483.13(c)(1)(i); as to Count III violated Section 400.23(8)(a), Florida Statutes, and
42 C.F.R. 483.20(k)(3)(i); as to Count IV, violated Sections 400.23(8)(a) and 400.147(2), Florida Statutes, and 42 C.F.R. Sections 483.25(j) and 483.75. In Count V, it is alleged that because Class I violations have occurred that additional surveys for a period of two years at six-month intervals must be conducted, the cost of which must be paid by the Respondent facility, citing Section 400.19(3), Florida Statutes.
The Second Amended Administrative Complaint advances a proposed remedy in the form of the imposition of fines in a proposed amount of $46,000.00, as well as the imposition of a conditional licensure status. In essence, the Second Amended Administrative Complaint asserts that the facility has failed to comply with the authority cited therein by failing to keep a resident free from physical and chemical restraints, other than those authorized by a physician's order, and for violating the requirement that restraints may not be used for purposes of
convenience, for punishment, or for reasons other than resident protection or safety, "Tag F221." The Petitioner alleges in essence as to "Tag F224" that the Respondent failed to prevent neglect by neglecting to assess, monitor, and "care-plan," a device related to the resident's hands (latex gloves), and did not develop and implement written policies and procedures to prevent mistreatment, neglect, and abuse of residents. As to "Tag F281," the Petitioner contends that the facility did not comply with the above statutory and regulatory authority by failing to ensure that services provided or arranged by the facility met professional standards of quality, by failing to ensure that the staff administered care in accordance with professional standards of practice with regard to the use of latex gloves for prevention of scratching and digging behavior with regard to wounds, and concerning properly obtaining physician's orders for medical or other types of restraints.
Concerning "Tag 490," the Petitioner alleges that the facility has violated Title 42 C.F.R. Section 483.75, which requires a facility to be administered in a manner that enables it to use its resources effectively and efficiently to obtain or maintain the highest practicable, physical, mental, and psycho-social well-being of each resident.
The Respondent timely requested an administrative hearing and during the course of pre-hearing procedure, a number of
motions in the nature of motions to dismiss and for more definite statement were adjudicated, such that the Agency was required to amend the Administrative Compliant twice and finally to file a more definite statement concerning the necessity for specific details and allegations as to the charges pled in the Second Amended Administrative Compliant, which more definite statement was filed immediately prior to hearing.
The cause came on for hearing as noticed. At the hearing the Agency presented the testimony of nine witnesses and submitted 20 exhibits into evidence. Two of the Agency's nine witnesses were presented by deposition. The Respondent facility, Heron Pointe, presented the testimony of two witnesses and submitted three exhibits into evidence. Upon conclusion of the proceedings, the parties requested a transcript thereof, which was duly filed, and availed themselves of the right to submit proposed recommended orders. An extended briefing schedule was stipulated by the parties and, additionally, the Petitioner requested and was granted an extension of that schedule, due to medical necessity on the part of the Petitioner's counsel, such that ultimately, proposed recommended orders were due to be filed on or before March 8, 2004. The Proposed Recommended Orders were timely filed and have been considered in the rendition of this Recommended Order.
FINDINGS OF FACT
The Petitioner is an Agency of the State of Florida charged with regulating and licensing nursing homes in Florida, and conducting surveys and evaluations of nursing homes in accordance with the provisions of Chapter 400, Florida Statutes, and specifically Section 400.23(7), Florida Statutes. The Respondent, Heron Pointe, is a licensed nursing home located in Brooksville, Florida.
The death of a resident occurred on October 1, 2002, in Heron Pointe's facility. In accordance with law the facility immediately reported the death to the Respondent Agency (AHCA). The resident is hereinafter referred to as "Resident One." Because of the reported death of Resident One, AHCA conducted a compliance survey of Heron Pointe on October 1-2, 2002. As a result of that survey, AHCA found four deficiencies, called in the parlance of nursing home regulations "tags." The tags were cited in AHCA survey report resulting from the October 1-2 survey and represent four different regulatory provisions. They are referred to hereinafter as Tags F221, F224, F281, and F490. Those tags or deficiency reports correspond to Counts I, II, III, and IV of the Second Amended Administrative Complaint.
Resident One was admitted to Heron Pointe from another nursing home facility because her family was not pleased with the care received at the other facility. She was admitted in
March 2003, with pressure sores, including one on her coccyx. She had a Foley catheter at that time, as well as a feeding tube. Resident One suffered from dementia and a number of other medical conditions and was placed in Hospice care on or about August 26, 2002. This was because of a terminal diagnosis by her physician.
Resident One was in a severely debilitated condition, which made it quite difficult to treat and heal the pressure sores which she had when she came to the facility. The nursing and medical staff aggressively treated the pressure sores and through effective nursing care were able to heal the pressure sore on the resident's coccyx.
Resident One also developed a small wound on her left hip while she was at Heron Pointe. Her condition continued to decline and she developed anxiety, restlessness, and self- abusive behavior as an adjunct of her debilitated mental condition. This caused her to frequently scratch at her skin, constantly remove wound dressings, and to dig at her hip wound. Resident One thus created a severe wound described as a "deep and painful tunneling hole" on her left hip. This behavior and the nursing staff's treatment of it in attempts to alleviate it are well documented in nursing notes. In fact the nursing staff testified that such severe self-abusive behavior had never been encountered in one of their residents. They aggressively
applied various nursing modalities to treat it and attempt to deal with it while keeping the resident comfortable.
A number of nursing and medical interventions were used to address the self-abusive behavior. Various medications were ordered by her treating physician to calm her and to alleviate any itching and pain that she might be experiencing at the hip wound site, which might be prompting her, in part, to dig at the wound with her finger and finger nails. A number of types of bandages were tried in an effort to find one which she would not readily remove. The staff positioned her in bed with her hands above the covers to dissuade her from digging at her hip and she was given stuffed animals as a distraction to attempt to keep her from wanting to dig at her hip wound. This is a professionally appropriate nursing practice in treating and dealing with residents with dementia. She was also placed in a room near the nurse's station where staff could more frequently and readily monitor her and observe her behavior and condition.
The above-described nursing approaches had some sporadic success, but her self-abusive behavior continued. The Hospice staff, which also was involved in the resident's care, suggested that the facility use latex gloves on the resident, which was an intervention the staff used with some success to address the resident's tendency to dig at the wound. While the gloves did not actually physically prevent the resident from
digging at the wound, they served as a distraction. The resident enjoyed wearing the gloves and would proudly show them to facility nurses and to some extent they seemed to distract her from her desire to dig at the hip wound. Although they did not stop the behavior entirely, they did lessen its destructive effect somewhat. They did not limit the resident in normal access to her body and other movements anymore than would bandages. Digging at a wound, in any event, does not constitute "normal access" to one's body. This intervention, however, like others used, had only limited success because the resident soon began taking off the gloves, which she was freely able to do.
In the early morning hours of October 1, 2002, the resident was noted to be increasingly anxious and fidgety, to the extent of pulling out her Foley catheter and pulling on her feeding tube. In an effort to distract the resident, a certified nursing assistant tried using the latex gloves on her hands, sometime before 4:00 a.m. The assistant notified the floor nurse that the resident had pulled out her Foley catheter, whereupon the nurse went into the resident's room to give medication prior to replacing the catheter. The nurse observed at that time that the resident was displaying the gloves to her as she often did and pulling them further on to her hands. The nurse again observed the resident at 6:00 a.m. that morning at
which point she was no longer wearing the gloves but was lying peacefully in bed and no longer fidgeting.
A certified nursing assistant observed the resident at about 9:00 a.m. on October 1, 2002, and found her unresponsive in her bed. The nurse was called to the room, examined the resident, and confirmed that the resident had expired, apparently by asphyxiation. At that time a latex glove was found in the resident's mouth.
Count I (Tag F221)
The Second Amended Administrative Complaint charges that the facility was not in compliance with Section 400.022(1)(o), Florida Statutes, and 42 C.F.R. Section 483.13(a). This statute and the related federal rule in essence mandate that a facility and its staff may not use physical or chemical restraints except those authorized in writing by a physician for a specified emergency purpose and for a limited period of time. They may not be used in lieu of staff supervision or merely for convenience, punishment, or reasons other than the protection or safety of residents. AHCA contends that the facility failed to ensure that Resident One was free of any restraint for which a medical symptom was not indicated.
It has not been established that the latex gloves used on Resident One were indeed a restraint. The term is not defined in the federal regulation nor in the state statute.
However, the State Operation Manual used by surveyors as guidance in applying the statute and the federal regulation, defines physical restraints as any physical or mechanical device, material, or equipment attached or adjacent to a resident's body that the individual resident cannot remove easily and which restricts freedom of movement or normal access to the resident's body. It is undisputed that this definition applies to the instant situation.
It is undisputed as well that Resident One could remove the gloves and indeed the un-refuted evidence showed that she could remove them easily. The resident removed the gloves frequently and could not have been able to remove them so frequently had they not been easily removable. There was no evidence that she had any difficulty in removing the gloves. Additionally, AHCA acknowledged that the gloves neither restricted the resident's freedom of movement nor prevented her from doing anything. The gloves may have resulted in diminished tactile sensation in the hands and fingers of the resident but, inasmuch as these types of gloves are used routinely for medical and nursing procedures, such reduction is minimal. Neither the testimony of nursing personnel nor any other evidence, such as medical or nursing literature or regulatory guidelines, suggests that latex gloves should be considered as restraints.
There is no evidence to suggest that any nursing home industry practice or standard would establish that latex gloves constitute a restraint. Heron Pointe's witness, Ms. Brock, who is accepted as an expert witness in long-term care nursing, established that latex gloves have been used on occasion for such purposes as keeping a bandage on a resident's hand and are not considered a restraint under those circumstances, nor do they require a physician's order. Gloves are readily accessible throughout all nursing homes and are typically kept in a wall dispenser in each resident's room, for use by staff and families and accessible to mobile residents. No effort is made to keep them away from residents, even those with cognitive impairment, and such procedures involving the placement and handling of latex gloves are not the subject of charged deficiencies in AHCA regulation and inspection of nursing homes.
AHCA contends that the gloves are inherently dangerous to residents with cognitive disabilities. This position, however, is refuted by the evidence establishing that it is a routine industry practice that residents and their families have ready access to the gloves, and the practice indeed continues at Heron Pointe, as well as elsewhere. AHCA has required no changes in accessibility to latex gloves as a result of its surveys of Heron Pointe. The opinion of AHCA's expert in
nursing home administration to the effect that the gloves are inherently harmful to a resident is not deemed credible.
AHCA has not established that the gloves were imposed for purposes of discipline or convenience, even if they could be deemed a restraint, which they are not, and has not established that the gloves were not required to treat the resident's medical symptoms. No evidence has been adduced to show that the gloves were applied to Resident One for purposes of disciplining her or as a convenience to the facility staff. Indeed, it was undisputed that the gloves were applied to address a difficult medical situation, the resident's self-destructive behavior causing her to mutilate her hip wound.
Count II: Tag F224
As to this charged deficiency, AHCA asserts that the facility was not in compliance with 42 C.F.R. Section 483.13(c)(1)(i), which mandates facilities to develop and implement written policies and procedures to prevent abuse and neglect or mistreatment of residents. The Agency contends that Heron Pointe failed to prevent neglect by not accessing, monitoring, and imposing a care plan for the device applied to the resident's hand, the latex gloves.
No concrete, persuasive evidence was presented to establish that the facility violated the regulatory requirement related to the charge in this count to develop and implement
policies. The state surveyor responsible for making the initial findings and report underlying this "tag" acknowledged that she had reviewed no policy or procedure of the facility and had not asked to see or review any policies of the facility. The un- refuted evidence indeed establishes that the facility has a written policy, and had implemented it, designed it to prohibit mistreatment, neglect, or abuse of residents. Un-refuted evidence also establishes that anti-neglect policies and procedures for nursing homes in Florida are designed to and required to address only the investigation of incidents involving residents and to establish procedures or protocols for notification of appropriate agencies. Such policies and procedures are not designed to nor required to address particular residents' care, incidents, or issues.
In the instant situation the evidence establishes that Heron Pointe followed its written and approved policy and procedure by making telephone notification to the various agencies it was required to notify when the incident involving the resident's death occurred, including notification of AHCA and conduct of its own internal investigation. Un-refuted evidence establishes that Heron Pointe followed all the required policies and procedures with regard to Resident One when the incident in question occurred.
Under the charge in this count AHCA espouses the premise that there was an act of neglect of Resident One and that one action of neglect will constitute a failure to implement the anti-neglect policy. It charges that the resident was neglected because the use of the gloves was not assessed, monitored, and "care-planned."
The assertion that the facility failed to assess, monitor, and care-plan the gloves, and that such was required, is based on the false premise that the gloves were restraints. As found above, the gloves indeed did not constitute restraints for Resident One and thus the use of them in this way will not bring them into the requirement or protocol postulated by AHCA. In fact, to the extent that AHCA suggests that every nursing intervention must be formally assessed be part of a care plan and that the failure to do so will constitute neglect, there was no evidence that such protocol is industry practice, required by regulations, nor accepted standards of reasonable, professional nursing practice. Indeed, nurses daily employ interventions for residents both to improve their comfort, as well as to alleviate aberrant behaviors. Such interventions include positioning residents with pillows, the use of distractive measures such as, for instance, stuffed animals with dementia patients, the use of compresses to reduce fevers, and many other routine nursing measures designed to improve resident comfort and medical
conditions. Such nursing interventions do not require a care plan, physician authorization, or formally-documented assessment, as established by the expert nursing testimony in this case. The use of the gloves in this instance falls within the realm of such normal, acceptable professional nursing practice.
AHCA also assents that Heron Pointe neglected Resident One by failing to take further measures to determine a physical cause for her scratching and itching. Its witness avers that there was inadequate contact with the resident's physician. Aside from the fact that these allegations were not clearly pled in the Second Amended Complaint and, therefore, should not be considered, the evidence establishes that these contentions are not accurate. Indeed, Resident One was seen numerous times by the physician or the physician's assistant assigned to her, and numerous changes were made for dressings and medications in an effort by the physician and the staff to relieve the resident's anxiety, itching, and pain.
Although AHCA witnesses suggested that the physician had not been made sufficiently aware of the resident's problems and her behavior, that testimony is not persuasive. The resident's records clearly contradict that position. In the month of September alone, for instance, Resident One was seen four times by the physician or the physician's assistant, and
the resident's primary nurse testified and documented that she was in nearly daily contact with the resident's physician concerning the resident's condition and progress.
There was simply no evidence that Resident One was neglected. The nurses checked Resident One far more often than most residents because of her behaviors and medical condition and their attempts to heal her pressure sores and keep dressings on her wounds. She was turned at least every two hours and sometimes hourly. Resident One's nurse's testimony shows that the staff were exceedingly attentive to the needs of the resident and did everything that they could think of within the realm of nursing practice to alleviate the resident's discomfort and medical condition. Use of the gloves was one of many interventions used to address the unusual situation of the resident's self-destructive behavior, behavior which the staff had clearly made the resident's physician aware of on a frequent basis. It was not evidence of neglect, but rather of concern for the resident's well-being.
Indeed, if there had been an official assessment of the gloves and if they had been formally written into a care plan, there would have still been no reason to foresee the possibility that the resident would put a glove in her mouth. None of her care-givers considered this as a possibility since the resident had not displayed any behavior to suggest such a
possibility. The resident could have just as easily removed a bandage or picked up another relatively small, necessary item in her care environment, placed it in her mouth, and asphyxiated herself. She had displayed no behavior to put the staff on notice that this was a foreseeable possibility.
Care of residents with dementia requires creativity by the nursing staff. No two residents exhibit the same set of behaviors. It is not a typical behavior for Alzheimer's residents to put things in their mouths. If a resident with dementia develops aberrant behaviors, they typically become repetitive, such as Resident One's self-mutilation. If Resident One were prone to putting items in her mouth, there were other items readily available to her to put in her mouth, and yet she had exhibited no such behavior before the day of her death. Without exhibiting such behaviors, there was no reason for the staff to have foreseen that she would put a latex glove in her mouth.
Count III: Tag 281
AHCA contends that the facility has violated 42 C.F.R. Section 483.20(k)(3)(i), which requires that services provided by the facility must meet professional standards of quality. Specifically AHCA maintains that the facility failed to ensure that the staff provided care in accordance with acceptable professional standards of practice for use of latex gloves for
the prevention of the scratching, digging behavior, and failed to ensure the obtaining of physician's orders for medical or other types of restraints, with regard to the latex gloves.
The assertion of this deficiency was also based on the false premise that the gloves constituted a restraint. AHCA witnesses opined in conclusory fashion, without a factual basis or support in any literature, that the use of gloves on a resident is a restraint and is inappropriate. The above-found facts established that the gloves were not used for convenience or punishment, were easily removable, and did not restrict access to the resident's body. Because these facts with regard to the use of the gloves were not proven, it was not established that they were restraints which require obtaining a physician's order. That not being established, it was not established that any accepted professional standards of quality of practice by nurses or staff members, for use of latex gloves, was violated.
Heron Pointe's expert nursing witness established other uses of latex gloves on residents by nurses, without a physician's order, which are within acceptable standards of nursing practice, as found concerning the previous count.
Ms. Brock opined and established that the gloves were a unique and innovative nursing measure under the circumstances presented by this resident, and were appropriate in terms of professional nursing and resident care practices for addressing the self-
destructive behavior exhibited by Resident One. Ms. Brock's testimony was persuasive and credible and is accepted in this regard.
Count IV: Tag F490
AHCA alleges that Heron Pointe violated 42 C.F.R. Section 483.75, because the facility was not administered in manner enabling it to use its resources effectively and efficiently to maintain or attain the highest practicable physical, mental, and psycho-social well-being of each resident.
The Agency relied on the factual allegations from previous counts of the Second Amended Administrative Complaint under the theory that the administrator is ultimately responsible for the operations and management of the facility and the carrying-out of approved facility policies. The evidence does not establish that the administrator or management of the facility failed to take action or neglected its duties concerning the allegations, in the counts of the Second Amended Administrative Compliant, however. The administrator promptly notified all appropriate agencies regarding the incident and death of Resident One in the manner provided for by the facility's policies and the regulations and statutes that apply to the facility. Indeed the Agency acknowledged that it would be impossible for an administrator to know all specifics concerning each resident, but the Agency took the position that
regardless of that impossibility that the administrator was charged with knowledge that the latex gloves were used on Resident One and that he should have made sure that they were not used.
The evidence, however, demonstrated that the administrator of Heron Pointe was generally and sufficiently aware of Resident One's condition and circumstances, in accordance with relevant regulatory requirements, and followed facility policies with regard to adequate staffing and adequate staff oversight and practice concerning the resident's care.
There was no evidence presented which would establish that any other resident had used or had been made to use latex gloves, or that any other resident had been the subject of the use of any inappropriate restraints, or that any other resident was at risk in any other way. This demonstrates that the incident with Resident One, however regrettable, was an isolated incident and does not constitute preponderant evidence that the facility and its administrator and administration failed to use the facility's resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psycho-social well-being of each resident. Unfortunately, the provision of appropriate or "highest practicable" levels of care to all residents of a facility and to individual residents, as
to that resident's specific problems, needs, and conditions, cannot always prevent a tragedy.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction of the subject matter of and the parties to this proceeding. §§ 120.569 and 120.57(1), Florida Statutes.
Section 400.23(7)(b), Florida Statutes (2001), provides that AHCA shall assign a standard or conditional licensure status to a nursing home depending on whether any Class I, Class II, or Class III deficiencies are uncorrected within a time established by the Agency and in compliance with rules and regulations. Section 400.23(7) states, in pertinent part, as follows:
The agency shall, at least every 15 months, evaluate all nursing home facilities and make a determination as to the degree of compliance by each licensee with the established rules adopted under this part as a basis for assigning a licensure status to that facility. The agency shall base its evaluation on the most recent inspection report, taking into consideration findings from other official reports, surveys, interviews, investigations and inspections. The agency shall assign a licensure status of standard or conditional to each nursing home.
A standard licensure status means that a facility has no Class I or Class II deficiencies and has corrected all Class III deficiencies within the time established by the agency.
A conditional licensure status means that a facility, due to the presence of one or more Class I or Class II deficiencies, or Class III deficiencies not corrected within the time established by the agency, is not in substantial compliance at the time of the survey with criteria established under this part or with rules adopted by the agency. If the facility has no Class I, Class II, or Class III deficiencies at the time for the follow-up survey, a standard license status may be assigned.
A Class I deficiency is:
A deficiency that the agency determines presents a situation in which immediate corrective action is necessary because the facility's noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. . .
§ 400.23(8)(a), Fla. Stat.
A facility is substantially affected by a conditional rating and/or administrative fine. Section 408.35, Florida Statutes, for example, which governs certificates of need, provides that an applicant's ability and record of providing quality of care are among the criteria for competitive review. Additionally, a facility cannot qualify for the "Gold Seal Program" if it has had a conditional rating within the previous
30 months. § 400.235, Fla. Stat. A conditional rating can substantially affect the reputation of a facility in the community and have a negative impact on staff morale and recruiting, as well as on decisions by residents and their families concerning use of the facility in the future. See
Spanish Gardens Nursing & Convalescent Center (Beverly Health & Rehab. Services, Inc.,) v. Agency for Health Care
Administration, 21 F.A.L.R. 132 (AHCA 1998).
AHCA has the burden of proving a basis for changing Heron Pointe's licensure status to a conditional status or rating and for establishing a basis for imposing an administrative fine. Florida Department of Transportation v. J.W.C Company, Inc., 397 So. 2d 778 (Fla. 1st DCA 1981); Balino v. Department of Health and Rehabilitative Services, 348, So. 2d
349 (Fla. 1st DCA 1977); Spanish Gardens, supra.
Federal regulations under 42 C.F.R., part 403 are made applicable under Florida law to nursing home regulations and proceedings arising therefrom through operation of Florida Administrative Code Rule 59A-4.1288. In this regard, the United States Department of Health and Human Services Departmental Appeal Board (DAB) decisions are helpful in interpreting the regulations at issue and their applicability to the facts and circumstances of this case.
Count I: Tag F221
The Petitioner Agency has failed to establish by preponderant evidence that the latex glove used on the resident constituted a restraint. Given the undisputed definition of a restraint as something which restricts normal access to one's body and cannot be removed easily, Count I of the Second Amended
Administrative Complaint is self-defeating. In that Count it is charged that Resident One was likely to remove the glove and cause herself serious injury or death. If she could do so, the gloves could not constitute, and were not, a restraint.
Even if the gloves could be construed to be a restraint, it has not been proven that a violation of 42 C.F.R. Section 483.13(a) has occurred. That regulation provides that a resident has a right to be free of restraints if they are imposed for purposes of discipline and convenience, and not required to treat the resident's medical symptoms. Similarly, Section 400.022(1)(o), Florida Statutes, prohibits use of restraints for reasons other than resident protection or safety. The DAB decisions are helpful and persuasive and applicable in interpreting the regulations at issue. In fact in Cross Creek
Heath Care Center v. Healthcare Financing Administration, DAB decision CR504 (1997) it was stated:
It is evident, both from the plain language of 42 C.F.R. Section 483.13(a), and from the location of this subpart within 42 C.F.R. Section 483.13, that the critical question which must be decided in concluding whether a facility is acting consistent with the restraints requirements is the facility's purpose in applying a restraint to a resident. A facility complies with the requirements of the regulation only when it is applying a restraint for a reason that is medically necessary. A facility contravenes the regulation whenever it applies a restraint for reasons of convenience or discipline. . . . In any case where HCFA
alleges under 42 C.F.R. Section 483.13(a) that a facility has applied a restraint improperly, the dispositive evidence will be evidence which establishes the facility's purpose in applying the restraint.
The Petitioner herein offered no evidence that the gloves were applied to Resident One for purposes of discipline or as a staff convenience. Indeed, it is was effectively undisputed that the gloves were applied to address a difficult situation, that is, the resident's self-destructive behavior, causing her to dig and mutilate her hip wound. It has not been proven by preponderant evidence that Heron Pointe violated Section 400.022(1)(o), Florida Statutes, and 42 C.F.R. Section 483.13(a).
Count II: Tag F224
The language of 42 C.F.R. Section 483.13(c)(1)(i) makes it clear that no violation can be established without evidence that a required policy was not developed or implemented. See Life Care Center of Hendersonville v. HCFA, DAB decision CR542 (1998). Having failed to review any facility policies, the Petitioner's charge appears to be based upon the premise that there was an action of neglect of Resident One, and that one act of neglect constitutes a failure to implement an anti-neglect policy facility-wide. This position is contrary to established law set by the DAB, and, furthermore, the evidence did not establish any neglect of Resident One. The Petitioner's
use of Tag F224, in light of the facts established, failed to properly interpret this federal regulation at issue.
In Life Care Center of Hendersonville v. Health Care Financing Administration, DAB CR542 (1998), the administrative law judge stated:
In evaluating a long-term care facility compliance with the regulation, the questions that must be answered are: (1) has the facility developed written policies and procedures that prohibit abuse, mistreatment or neglect of residents; and (2) have those policies been implemented.
The question [regarding implementation] cannot be answered simply by identifying random episodes of abuse, mistreatment or neglect which may have occurred at a facility. A conclusion that a facility has failed to implement anti-abuse, mistreatment or neglect policies does not necessarily follow from evidence of an isolated episode or episodes of abuse, mistreatment or neglect. A facility may be found to have implemented the required policy even if an isolated instance of abuse, mistreatment or neglect occurs at the facility despite the facility's best efforts.
That is underscored by the guidance which HCFA gives to state survey agency surveyors. The State Operations Manual provides that: the intent of . . . [42 CFR § 483.13] is to assure that the facility has in place an effective system that . . . prevents mistreatment, neglect, and abuse of residents.
. . . However, such a system cannot guarantee that a resident will not be abused; it can only assure that a facility
does whatever is in its control to prevent mistreatment, neglect and abuse of residents.
This approach to the interpretation of the regulation has been followed by the Petitioner Agency in one Final Order. AHCA v. Plantation Bay Rehabilitation Center, Case No. 01-1983 (DOAH February 28, 2002). However, in Beverly Health and
Rehabilitation Center - Coral Trace v. AHCA, Case No. 01-1616 (DOAH February 18, 2002), the Agency declined to follow the federal precedents in its interpretation of these "tags." In any event, however, the language of these regulations does not support the Agency's interpretation in this case. The regulation itself demonstrates that the tags involved here address the development and adequacy of the facility's policies to prevent abuse or neglect, not individual, isolated instances of abuse or neglect, if such had been proven, which they were not under the evidence and facts of this case. AHCA simply failed to factually establish a violation of the regulation cited and relied upon, failed to show an act of neglect, nor that the facility failed to have in place written and implemented policies addressing the prohibition of abuse, mistreatment, or neglect of residents. Thus it has not been established that Heron Pointe violated 42 C.F.R. Section 483.13(c)(1)(i).
Count III: Tag F281
The guidelines for interpreting this regulation, presented by and relied upon by the Petitioner in this case, define "professional standards" in terms of clinical literature, manuals, and published standards. Since the Petitioner pointed to no such material regarding the use of latex gloves on residents, it failed to meet the first step in proving a violation. It failed to establish by preponderant evidence what professional standard was violated and the assertion, as to this count, was predicated upon the erroneous assumption that the gloves constituted a restraint, which the evidence clearly establishes they were not.
Moreover, the testimony of Ms. Brock, which was accepted, and other evidence adduced by the Respondent, established that all relevant professional nursing and nursing home staff standards were complied with, with regard to the care provided Resident One and, in fact, she was actually provided a higher level of care by the staff than the pertinent regulations and guidelines interpreting them require. In summary, preponderant evidence does not establish that Heron Pointe violated 42 C.F.R. Section 483.20(k)(3)(i).
Count IV: Tag F490
The Agency's charge concerning 42 C.F.R. Section
483.75 depends upon a determination that there were violations
under the deficiency citations addressed above. Since none of the violations or alleged deficiencies were proven, this charge must also fail. Additionally, AHCA did not present any preponderant evidence regarding any failure on the part of the administration of the facility, even if the other violations had been proven. The persuasive, credible evidence, culminating in the above Findings of Fact, establishes that Hereon Pointe was administered in a manner "enabling it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psycho-social well-being of each resident," including Resident One and, in fact, accorded a higher level of care than absolutely required by the regulations for Resident One, given the staff's awareness of and concern for her debilitated condition. The Petitioner has not proven that Heron Pointe violated 42 C.F.R. Section 483.75.
Deficiency Classification
If it be assumed arguendo that the Petitioner had established any deficient practice, there is no evidence to support the existence of a Class I deficiency under the facts of this case. Asserting that the deficiencies at Heron Pointe were Class I deficiencies presumes that Heron Pointe should have known that latex gloves were a danger to Resident One and that they were "likely to cause" serious injury or death. The evidence was clear that latex gloves are ubiquitous in all
nursing homes, readily accessible to mobile residents, as well as to family and staff, and allowed by appropriate regulatory standards and nursing standards. There was no reason for any staff member or the administration of the facility to believe that they posed any particular danger to Resident One.
The DAB has held that the standards do not impose strict liability on facilities for all accidents, Odd Fellow and Rebehak Health Care Facility v. HCFA, DAB No. 1839(2002), citing Asbury Care Center at Johnson City v. HCFA, DAB No. 1815 (2002); Price Hill Nursing Home v. HCFA, DAB No. 1781 (2001). As recently stated in Northgate Healthcare Center v. HCFA, DAB No. CR1005 (2003), "a facility is not liable per se for every accident that occurs in its premises nor is it charged with liability for hazards that reasonable persons would not foresee." In Asbury Center at Johnson City v. HCFA, DAB No. CR807 (2001), it was held "in order to meet the overall quality of care requirement . . . the facility is not required to do the impossible or be a guarantor against unforeseeable occurrence." That the resident herein might remove a glove and place it in her mouth was simply not foreseeable under the facts established in this case.
AHCA has failed to establish by preponderant or clear and convincing evidence that any of the alleged deficiencies existed. It would thus be inappropriate for it to issue a
conditional rating or to impose an administrative fine. Finally, in this connection, Count V of the Second Amended Administrative Complaint is a derivative count which requests an additional assessment, under the authority cited, to pay for costs of additional surveys which are required under the cited authority, if a facility is determined to be guilty of any Class I deficiency. No Class I deficiency has been established and, therefore, this count should be dismissed as well.
Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore,
RECOMMENDED that a Final Order be entered by the Agency for Health Care Administration dismissing the Second Administrative Complaint in its entirety; issuing a standard rating to the Heron Pointe facility; and finding that no deficiencies described under the tags and regulations cited and discussed above have occurred, correcting all relevant records concerning licensure or regulation of the Respondent's facility to reflect the absence of any deficiencies at Heron Pointe stemming from the survey of October 1-2, 2002.
DONE AND ENTERED this 12th day of May, 2004, in Tallahassee, Leon County, Florida.
S
P. MICHAEL RUFF 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 Clerk of the
Division of Administrative Hearings this 12th day of May, 2004.
COPIES FURNISHED:
Michael O. Mathis, Esquire
Agency for Health Care Administration Fort Knox Building III, Suite 3431 2727 Mahan Drive
Tallahassee, Florida 32308
Gerald L. Pickett, Esquire
Agency for Health Care Administration Sebring Building, Suite 330K
525 Mirror Lake Drive, North St. Petersburg, Florida 33701
Donna Holshouser Stinson, Esquire Broad and Cassel
215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300
R. Davis Thomas, Jr., Esquire Broad and Cassel
215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300
Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3
Tallahassee, Florida 32308
Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431
2727 Mahan Drive
Tallahassee, Florida 32308
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Aug. 04, 2004 | Recommended Order | Petitioner failed to prove that latex gloves were "restraints" requiring a doctor`s order, to establish neglect of the resident, and to establish that the facility did not implement a written policy designed to prevent abuse or neglect of the residents. |
| Jul. 15, 2004 | Agency Final Order |
AGENCY FOR HEALTH CARE ADMINISTRATION vs ROBERT J. MEEK, D.O., 03-000164 (2003)
DEPARTMENT OF HEALTH, BOARD OF ORTHOTISTS AND PROSTHETISTS vs MARK BOWLIN, OFA, 03-000164 (2003)
DEPARTMENT OF HEALTH, BOARD OF ORTHOTISTS AND PROSTHETISTS vs MARK BOWLIN, OFA, 03-000164 (2003)
DEPARTMENT OF HEALTH, BOARD OF CHIROPRACTIC MEDICINE vs ROBERT WHITNEY, D.C., 03-000164 (2003)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN LANDI, M.D., 03-000164 (2003)
