vs. )
Respondent. )
Case No. 01-3143
Administrative Law Judge (ALJ) Daniel Manry conducted the administrative hearing of this case on November 15, 2001, in Orlando, Florida, on behalf of the Division of Administrative Hearings (DOAH).
St. Petersburg, Florida 33701
For Respondent: R. Davis Thomas, Qualified Representative
The issue in this case is whether Respondent committed the allegations in the notice of intent to assign a
conditional license and, if so, whether Petitioner should have changed the rating of Respondent's license from standard to conditional from June 13, 2001, through July 11, 2001.
By letter dated June 28, 2001, Petitioner alleged that Respondent had violated various provisions of Florida Statutes and the Florida Administrative Code and provided notice that Petitioner changed Respondent's license rating from standard to conditional. Respondent timely requested an administrative hearing.
The ALJ initially set the case for hearing on October 25 and 26, 2001. On September 14, 2001, Petitioner filed an unopposed motion for continuance. On September 19, 2001, the ALJ issued an order granting the continuance and rescheduled the hearing for November 15 and 16, 2001.
The style of the documents filed in the case prior to November 15, 2001, denoted the state agency as Respondent and denoted the nursing home facility as Petitioner. That style, however, misrepresented the burden of proof in the case. The state agency has the burden of proof to substantiate the proposed agency action and properly should appear as Petitioner in the style of the case. Pursuant to the agreement of the parties on November 15, 2001, the ALJ amended the style of the case, nunc pro tunc, to show the state agency
as Petitioner and to denote the nursing home facility as Respondent.
At the hearing conducted on November 15, 2001, Petitioner presented the testimony of one witness and submitted one composite exhibit, consisting of 14 documents, for admission as evidence. Respondent presented the testimony of one witness, and submitted one composite exhibit, consisting of 22 documents, for admission in evidence. The identity of the witnesses and exhibits and any attended rulings are set forth in the two-volume Transcript of the hearing filed on December 31, 2001. Proposed Recommended Orders were submitted by both parties, and were duly considered.
Petitioner is the state agency responsible for licensing and regulating nursing homes inside the state. Respondent operates a licensed nursing home at 710 North Sun Drive, Lake Mary, Florida 32746 (the "facility").
Petitioner conducted a complaint investigation on June 13, 2001 (the "June survey"). Petitioner noted the results of the complaint investigation on the Health Care Federal Administration form entitled "Statement of Deficiencies and Plan of Correction." The parties refer to the form as the HCFA 2567-L or the "2567".
The 2567 is the document used to charge nursing homes
with deficiencies that violate applicable law. The 2567 identifies each alleged deficiency by reference to a tag number (the "tags"). Each tag of the 2567 includes a narrative description of the allegations against Respondent and cites a provision of the relevant rule or rules in the Florida Administrative Code violated by the alleged deficiency. In order to protect the privacy of nursing home residents, the 2567 and this Recommended Order refer to each resident by a number rather than by the name of the resident.
Tag F314 is the only allegation at issue in this proceeding. Tag F314 generally provides that a facility must ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless they were unavoidable; and the resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.
Tag F314, in relevant part, alleges that the facility:
. . . did not insure the prevention of
pressure sore development or provide that necessary treatment for pressure sores which had developed in the case of one of four residents.
Applicable federal and state laws require Petitioner to assign a rating to the deficiency alleged in the 2567. The rating required by federal law is for scope and severity.
Petitioner assigned a G rating to Tag F314. A G rating means that the alleged deficiency was "isolated."
State law requires Petitioner to assign a class rating. Petitioner assigned a Class II rating to the deficiency alleged in Tag 314. A Class II rating is authorized in Section 400.23(8)(b), Florida Statutes (2001), for any deficiency that has
"compromised the resident's ability to maintain or reach his or her highest practicable physical, mental and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services."
The Class II rating is the only rating at issue in this proceeding. (All statutory references are to Florida Statutes (2001) unless otherwise stated.)
When Petitioner alleges a Class II deficiency in the 2567, applicable rules require Petitioner to change the rating of the facility's license. Effective June 12, 2001, Petitioner changed to rating of the facility's license from standard to conditional.
Petitioner conducted a follow-up survey on July 11, 2001 (the "July survey"). Petitioner determined that Respondent had corrected the deficiency alleged in Tag F 314 in June. Effective July 11, 2001, Petitioner changed the rating of the facility's license from conditional to standard.
The Class II rating from Petitioner rests on the allegations in Tag 314. The first allegation is that Respondent did not prevent the development of a pressure sore on the right buttock of Resident 1. The second allegation is that the facility failed to provide the treatment necessary to treat the pressure sore.
The facility admitted Resident 1 on October 19, 2000. Between the date of admission and June 4, 2001, Resident 1 did not develop any pressure sores. However, on June 4, 2001, a certified nursing assistant ("CNA") noticed an open area on the resident’s right buttock while showering the resident. The CNA notified the attending nurse.
A threshold issue is whether the area of concern on Resident 1 was a pressure sore or a blister caused by incontinence and chafing from the resident's diaper. The nursing staff described the identified area on a document in the resident’s medical chart called a "pressure ulcer report."
Petitioner contends that the use of a "pressure ulcer report" by Respondent is an admission by Respondent and that Respondent has the burden to prove that the area was not a pressure sore. However, the burden of proof is on Petitioner to show that the area of concern is a pressure sore.
Petitioner promulgates a written definition of a pressure sore in the guidelines that Petitioner requires its surveyors to use in interpreting the regulatory standard of Tag F314. Petitioner defines a pressure sore as:
. . . ischemic ulceration and/or necrosis of tissues overlying a bony prominence that has been subjected to pressure, friction or sheer.
Section 120.68(7)(e)3 prohibits Petitioner from deviating from its officially stated policy unless Petitioner explains the deviation. Petitioner failed to provide any evidence for deviating from its written definition of a pressure sore.
Ischemic ulceration or necrosis of tissue that has been subjected to pressure, friction, or sheer is not a pressure sore, as defined by Petitioner, if the area does not overlie a bony prominence. The parties disagree as to the location of the area of concern on Resident 1.
Petitioner's surveyor is an expert in nursing practices and procedures. She observed the area of concern on Resident 1 during the June survey. The surveyor testified at the hearing that the area of concern was located over the resident’s ischial tuberosity; i.e., the bone on which the resident placed her weight when she sat.
The facility's director of nurses is also an expert in nursing practices and procedures. The director observed the area immediately after the survey and testified that it was located in the fleshy part of the resident’s buttocks and was not over any bony prominence.
The preponderance of evidence did not show that the area of concern on Resident 1 was located over a bony prominence. The area of concern was located in the same location as the elastic band of the diaper that the resident wore for her incontinence. The area of concern was likely caused by the combination of the resident’s incontinence and chafing from the diaper.
The pressure ulcer report prepared by the nursing staff contains the outline of a human body on which the nursing staff marked the location of the area of concern on Resident 1 when staff first identified the area. The report shows that the area of concern is located in the fleshy part of the resident’s right buttock. The report did not indicate that the area of concern was located in the area on which the resident would have placed her weight when she was seated or prone.
Even if the area of concern were located at the ischial tuberosity other factors belie a diagnosis of pressure sore. Pressure sores typically involve deep tissue damage,
have drainage and odor, and require a long time to heal. The pressure ulcer report indicated that the area identified on the resident was small in size, had scant odor and no drainage, and healed by July 3, 2001. All of the surrounding facts and circumstances indicate that the area of concern on Resident 1 was not a pressure sore but was a blister caused by chafing from the diaper the resident wore for her incontinence.
The "pressure ulcer report" for Resident 1 classified the area of concern as a stage II. A stage II involves
a partial thickness loss of skin layers either dermis or epidermis that presents clinically as an abrasion, blister or shallow crater.
The area was further described in the report as being 0.7 by
0.7 centimeters in size with scant serous drainage, no odor, and pink in appearance. The director of nurses testified that the area presented as a "dry blister."
Assuming arguendo that the area of concern on Resident 1 was a pressure sore, there are two additional issues to be determined. One issue is whether development of the alleged pressure sore was unavoidable due to the resident’s clinical conditions. The other issue is whether the facility failed to provide the treatment and services
necessary to promote healing after the alleged pressure sore developed.
Petitioner promulgates guidelines for Tag F324 for use by surveyors in determining whether a pressure sore is unavoidable. The guidelines state in relevant part:
. . . a determination that development of a pressure sore was unavoidable may be made only if routine preventative and daily care was provided [by the nursing home].
The guidelines define routine preventative care as:
. . . turning and proper positioning, application of pressure reduction or relief devices, providing good skin care, providing clean and dry bed linens, and maintaining adequate nutrition and hydration as possible.
The guidelines instruct surveyors to determine whether a facility complies with the foregoing standards "consistently" rather than one hundred per cent of the time.
When the facility admitted Resident 1 in October, 2000, she was immobile and had several compromising diagnoses. They included atrial fibrillation; chronic ischemic heart disease and coronary atherosclerosis (diseases of the heart and arteries); abnormal loss of weight; angina pectoris; senile dementia; a kidney infection; and incontinence of both bowel and bladder. The clinical conditions placed Resident 1 at high risk for the development of pressure sores. The surveyor guidelines for Tag F314 state that a resident who is
immobile, has continuous urinary incontinence, chronic bowel incontinence, and chronic heart disease is at high risk for the development of pressure sores.
At the time of admission, the nursing staff at the facility assessed Resident 1 as being at risk for the development of pressure sores due to her incontinence and immobility. They designed a care plan to prevent the development of pressure sores. The care plan included frequent turning and repositioning of the resident, weekly skin assessments by a nurse, skin checks during care and bathing, and prompt incontinence care. The parties agree that the interventions in the care plan met the regulatory requirements for preventative care under Tag F314.
With one exception, Petitioner does not allege that the facility failed to provide routine preventative care to the resident. Respondent does not dispute that the facility did not perform weekly skin checks for three weeks in May preceding the identification of the area of concern on Resident 1. However, the failure to perform those skin checks did not cause Resident 1 to develop a pressure sore.
A weekly skin check is a head-to-toe assessment of a resident’s skin by a nurse. Since a nurse can only observe a pressure sore after it has appeared on a resident, this assessment is not preventative in nature. Instead, it is
designed to assure that appropriate and immediate treatment can be provided to the area after a reddened area develops.
Even if weekly examinations of a resident’s skin were an integral part of a plan intended to prevent the development of pressure sores on Resident 1, the facility necessarily exceeded this standard with regard to the resident’s right buttock where the area of concern actually occurred. Facility staff observed the resident’s buttock more than once a day when the resident received incontinence care, bath, or showers. Consistently through May and June, the resident’s chart shows that the resident was incontinent at least three times a day and that she received a partial bath or full shower at least once a day.
On June 4, 2001, facility staff in fact observed a reddened area during the resident's shower. Petitioner submitted no evidence that the facility could or should have been observing the resident’s buttock more frequently than its staff actually did or that the area could have been identified any earlier. The preponderance of evidence shows that the facility consistently implemented the component of its care plan that required monitoring of the resident’s buttock.
The care plan for Resident 1 included two other primary components to prevent pressure sores. One component was prompt incontinence care. The other was turning and
repositioning of the resident every two hours to relieve pressure over areas susceptible to breakdown. Petitioner alleges that the facility failed to comply with these components during the June survey.
Proving that a facility consistently turns and repositions a resident and provides prompt incontinence care is problematic for a facility. Those interventions are routine care. There is no regulation or standard that requires nurses to chart routine care. Because these interventions are not typically charted, a nursing home will not typically have documentary evidence to demonstrate that the interventions were provided to a resident.
The facility provided sufficient evidence to show that the interventions of repositioning and prompt incontinence care were provided to Resident 1 during the June survey. The facility provided incontinence care to the resident at least three times a day. With regard to turning and repositioning the resident, the director of nursing testified that she saw staff turning and repositioning the resident prior to the survey.
Resident 1 was at high risk of developing pressure sores. If staff had not consistently turned and repositioned the resident and provided prompt incontinence care, it is more likely than not that the resident would have developed serious
pressure ulcers on most or all of her weight bearing surfaces. The appearance of one small area on the resident and the absence of any other areas over any bony prominence is persuasive evidence that the facility consistently turned and repositioned the resident and consistently provided her with prompt incontinence care.
The final issue is whether the facility provided the treatment to Resident 1 that is necessary for healing of the alleged pressure sore. Petitioner agrees that the facility developed an appropriate care plan for the identified area immediately upon its discovery.
An order in the care plan developed after discovery of the alleged pressure sore called for application of a duoderm patch to the wound. Petitioner alleges that the facility did not follow the order because the surveyor observed no patch on the resident during the survey.
It is more likely than not that the duoderm patch came off of Resident 1 during an episode of incontinence prior to the time that the surveyor observed the resident. Duoderm patches commonly come off when a resident has an incontinent episode.
Regardless of why the patch was not on Resident 1 during the survey, the absence of the patch one time during the survey does not demonstrate that staff consistently failed
to comply with the order calling for the patch. The instance observed by Petitioner's surveyor was the only instance identified by the surveyor as a failure to follow the resident's care plan. The resident’s medication administration records demonstrate that facility staff applied the duoderm patch in all other instances in compliance with the doctor’s order. Furthermore, the facility continued to provide the routine preventative care called for by the care plan. Petitioner did not show that the facility consistently failed to follow the care plan for Resident 1 as alleged in Tag F314.
The area of concern on Resident 1 healed quickly and progressively after it was discovered. Petitioner offered no evidence that the alleged pressure sore did not heal or that the resident was otherwise harmed as a result of the failure to place a duoderm patch on the resident on June 13, 2001.
The pressure ulcer report and nurse’s notes indicate that the wound healed by July 3, 2001. The records noted with each successive entry after June 4, 2001, that the area was smaller in size. The area demonstrated characteristics of healing, including the absence of any odor or drainage, and pink granulating tissue.
Resident 1 was at high risk for pressure sores, and pressure sores do not typically heal quickly. The progressive
pattern of healing indicates that the facility provided the necessary and effective treatment for the area of concern on Resident 1.
CONCLUSIONS OF LAW
DOAH has jurisdiction over the parties and subject matter in this proceeding. Sections 120.569 and 120.57(1). The parties received adequate notice of the administrative hearing.
Petitioner has the burden of proof in this proceeding. Petitioner must show by a preponderance of the evidence that Respondent committed the deficiencies alleged in Tag F314. Florida Department of Transportation v. JWC Company, Inc., 396 So. 2d 778 (Fla. 1st DCA 1981); Balino v. Department of Health and Rehabilitative Services, 348 So. 2d
349 (Fla. 1st DCA 1997). For the reasons stated in the Findings of Facts and incorporated by this reference, Petitioner failed to satisfy its burden of proof.
Tag F314 encompasses the regulatory standard contained in 42 CFR Section 483.25(c). The federal regulation provides in relevant part:
Based on the comprehensive assessment of a resident, the facility must ensure that (1) 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 (2) a resident having pressure sores receives necessary treatment
and services to promote healing, prevent infection and prevent new sores from developing.
Petitioner must only show that Resident 1 developed a pressure sore after admission to the facility. The burden of proof then shifts to the facility to demonstrate that any pressure sore that developed on a resident after admission was unavoidable due to the resident’s clinical conditions.
Emerald Oaks v. Agency for Health Care Administration, 774 So. 2d 737 (Fla. 1st DCA 2000). Petitioner stipulated at hearing that Petitioner has the burden of showing that the facility failed to provide the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing.
Petitioner failed to show by a preponderance of evidence that Resident 1 developed a pressure sore after admission to the facility. The area did not satisfy the definition of a pressure sore in Petitioner's written policy. Petitioner failed to explain why it deviated from its written definition of a pressure sore in this case. Section 120.68(7)(e)3.
Even if the area of concern on Resident 1 were a pressure sore, Respondent showed the alleged pressure sore was unavoidable because of the resident's clinical conditions and
because Respondent provided the treatment necessary to promote healing.
Section 400.23(7)(a) defines a standard rating, in relevant part, to mean:
. . . a facility has no class I or II deficiencies and has corrected all class III deficiencies within the time established by the Agency.
Petitioner failed to prove that there was a Class I or II deficiency or an uncorrected Class III deficiency at the facility during the June survey. It was thus inappropriate for Petitioner to issue Lake Mary a conditional rating on that date.
RECOMMENDED that the Agency for Health Care Administration enter a Final Order finding that there was no basis upon which the agency could have issued a Conditional rating to Respondent on June 13, 2001, deleting the deficiency described under Tag F314, and issuing a Standard rating to Respondent to replace the previously issued Conditional rating.
DONE AND ENTERED this 5th day of March, 2002, in Tallahassee, Leon County, Florida.
Filed with the Clerk of the Division of Administrative Hearings this 5th day of March, 2002.
525 Mirror Lake Drive North Sebring Building, Room 310J St. Petersburg, Florida 33701
R. Davis Thomas, Jr. Broad & Cassel
William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive
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.
