STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
AGENCY FOR HEALTH CARE )
ADMINISTRATION, )
)
Petitioner, )
)
vs. ) Case No. 01-1983
) PLANTATION BAY REHABILITATION ) CENTER, )
)
Respondent. )
__________________________________)
RECOMMENDED ORDER
Pursuant to notice, a formal hearing was held in this case on August 15, 2001, at Orlando, Florida, before Susan B. Kirkland, a designated Administrative Law Judge of the Division of Administrative Hearings.
APPEARANCES
For Petitioner: Patricia J. Hakes, Esquire
Agency for Health Care Administration
525 Mirror Lake Drive North Room 310J
St. Petersburg, Florida 33701
For Respondent: R. Davis Thomas, Jr.
Qualified Representative Broad and Cassel
215 South Monroe Street, Suite 400 Post Office Box 11300
Tallahassee, Florida 32302-1300
STATEMENT OF THE ISSUES
Whether Respondent should be issued a Conditional rating from March 15, 2001, to June 11, 2001, based on surveys
completed on March 15, 2001, and April 19, 2001.
PRELIMINARY STATEMENT
On March 15, 2001, Petitioner, Agency for Health Care Administration (AHCA), concluded an annual survey of Respondent, Plantation Bay Rehabilitation Center (Plantation Bay), and determined that Plantation Bay had failed to meet the standards set forth in 42 CFR Section 483.13(c), 42 CFR Section 483.25, and 42 CFR Section 483.25(m)(1), which regulations are incorporated by reference in Rule 59A-4.1288, Florida Administrative Code. A follow-up survey was conducted on April 19, 2001, and AHCA again determined that Plantation Bay had failed to meet the standard in 42 CFR Section 483.25(m)(1).
Based on the survey results, AHCA issued a Conditional rating to Plantation Bay, effective March 15, 2001. On April 9, 2001, Plantation Bay filed a Petition for Formal Hearing, challenging the Conditional rating.
This case was originally styled Plantation Bay Rehabilitation Center v. Agency for Health Care Administration, but at the final hearing it was determined
that the case should be styled Agency for Health Care Administration v. Plantation Bay Rehabilitation Center because AHCA had the burden to establish
that Plantation Bay should receive a Conditional rating. The style has been changed to reflect this determination.
At the final hearing, Petitioner called Michelle Dillehay, R.N.; Jane Woodson, R.N.; and Mindy Seltzer, R.D. Petitioner's Exhibits 1-6 and 8-12 were admitted in evidence.
At the final hearing, Respondent called Wendy London, Ph.D., and Julie Dawkins, R.N., as its witnesses.
Respondent's
Exhibits 1-6 were admitted in evidence.
The parties entered into a Prehearing Stipulation, in which they agreed to certain facts, which have been incorporated in this Recommended Order to the extent they are relevant.
The parties agreed to file proposed recommended orders within ten days of the filing of the transcript. The one- volume Transcript was filed on August 30, 2001. On September 4, 2001, a Joint Motion for Extension of Time to File Proposed Recommended Order was filed. The motion was granted, and the time to file proposed recommended orders was extended to September 21, 2001.
Petitioner filed Petitioner's Proposed Recommended Order on September 24, 2001. Respondent filed the Proposed Recommended Order of Respondent on September 21, 2001. The parties' Proposed Recommended Orders have been considered in rendering this Recommended Order.
FINDINGS OF FACT
Plantation Bay is a nursing home located in St.
Cloud, Florida. Every fifteen months AHCA conducts a survey to determine if the facility is in compliance with applicable regulatory standards. During a survey, surveyors will observe and interview residents, observe care that is administered to residents, review medical records, and interview staff and family members. Based on the results of the surveys AHCA conducts, it determines whether the facility should receive a Standard or Conditional licensure rating.
After AHCA completes the survey of a nursing home, it issues a report of its findings, commonly called a "2567," which describes any deficiencies found by the surveyors. The deficiencies are organized by "Tags." A Tag identifies the applicable regulatory standard that the surveyors believe has been violated and provides a summary of the violation, specific factual allegations that the surveyors believe support the violation, and two ratings which indicate the severity of the deficiency.
One of the ratings identified in a Tag is a "scope and severity" rating, which is a letter rating from A to L with A representing the least severe deficiency and L representing most severe. The second rating is a "class" rating, which is a numerical rating of I, II, or III, with I representing the most severe deficiency and III representing the least severe deficiency.
AHCA conducted a survey of Plantation Bay, on March 15, 2001, and alleged that there were three deficiencies, which it described under Tags F224, F309, and F332 of a survey report. AHCA assigned a state class rating of II and a federal scope and severity rating of G to both the F224 and F309 deficiencies. A scope and severity rating of "G" is one which AHCA determines is an isolated deficiency that caused actual harm (that is not immediate jeopardy) to a resident.
AHCA assigned a state class rating of III and a federal scope and severity rating of E to the F332 deficiency.
Based on its determination that there were two Class II deficiencies at Plantation Bay, AHCA changed Plantation Bay's licensing rating from Standard to Conditional, effective March 15, 2001.
AHCA conducted a follow-up survey of Plantation Bay on April 19, 2001, to determine if the deficiencies cited on March 15, 2001, had been corrected. AHCA determined that the
facility had corrected the F224 and F309 deficiencies but, based on new factual allegations, re-cited Plantation Bay for a deficiency under Tag F332. The F332 deficiency was assigned a Class III rating and a scope and severity rating of E. Because AHCA believed this deficiency had not been corrected, AHCA continued the Conditional rating at Plantation Bay.
AHCA changed Plantation Bay's Conditional licensure rating to Standard, effective June 11, 2001.
In the March 15, 2001, survey AHCA alleged under Tag F224 that Plantation Bay violated the standard contained
in 42 CFR Section 483.13(c) and under Tag F309 that Plantation Bay violated the standard contained in 42 CFR Section 483.25. AHCA contends that Plantation Bay failed to provide appropriate monitoring and care to Resident 10 in relation to Tag F224 and failed to reduce the risk of potential decline and to maintain the highest practicable physical well being for Resident 10 in relation to Tag F309.
Plantation Bay has procedures which the nursing staff are to follow when a resident has an elevated blood pressure level. The nurse is to continue to monitor the resident's blood pressure, notify the next shift of the resident's blood pressure, and contact the resident's physician if the resident's blood pressure continues to be elevated.
Resident 10 was diagnosed with cardiovascular disease, cerebral vascular accident, hypertension, and cardiac dysrhythmia. She was prescribed 20 milligrams of Monopril every 12 hours.
On March 2, 2001, a nurse measured Resident 10's blood pressure level at 210/90, which was a high reading for Resident 10. Standard nursing procedure called for the attending nurse to continue monitoring Resident 10's blood pressure and to notify the oncoming nursing staff and Resident 10's physician. The nurse failed to do any of these things.
On March 4, 2001, Resident 10's family complained to Plantation Bay about Resident 10's cough and congestion. A nurse took Resident 10's temperature, but did not take Resident 10's blood pressure level.
On March 12, AHCA's surveyor, in reviewing
Resident 10's Vital Sign Flow Record, noted that from May 20, 2000, to March 2, 2001, the highest blood pressure recorded in Resident 10's Vital Sign Flow Record had been 184/72. The surveyor further noted that no further monitoring had been done since March 2, 200l. When the AHCA surveyor interviewed the nurse who had taken Resident 10's blood pressure level on March 2, 2001, and asked why no further monitoring had been done, the nurse replied that another emergency had occurred during her shift on March 2, 200l, and she had done nothing
about the high blood pressure reading because it had "slipped her mind."
On March 13, 2001, when the AHCA surveyor noted the lack of monitoring Resident 10's blood pressure level since March 2, 2001, she asked the nurse on duty whether she was aware that Resident 10 had an elevated blood pressure on March 2, 2001. The nurse replied that she was not aware of the elevated blood pressure. The nurse checked Resident 10's blood pressure, which was 202/82. The nurse indicated that she was going to contact Resident 10's physician. The surveyor asked what Resident 10's temperature was, and the nurse replied that she had not checked the temperature.
Thirty minutes later, the nurse checked Resident 10's temperature and blood pressure. The temperature
was 99.6 degrees Fahrenheit, and the blood pressure was 210/100. This information was sent to Resident 10's doctor.
An hour and a half later, Resident 10's blood pressure was 210/90. Ninety minutes later, the blood pressure was 210/100. The information had been sent to Resident 10's doctor, but the doctor had not responded. Two and a half hours later, Resident 10 was sent to the emergency room by order of her physician. Resident 10's medication was changed to 40 milligrams of Monopril every 12 hours.
An elevated blood pressure could worsen cardiovascular disease, cerebral vascular accident, hypertension, and cardiac dysrhythmia, conditions with which Resident 10 had been diagnosed. Thus, the failure of Plantation Bay on March 2, 2001, to monitor the blood pressure, to report the elevated blood pressure level to the oncoming shift, and to notify Resident 10's physician had a direct relationship to the health of Resident 10 and imposed an immediate threat to the health of Resident 10.
AHCA also alleged under Tag 309 from the March 15, 2001, survey that Plantation Bay violated the standard of care set forth in 42 CFR Section 483.25. Plantation Bay failed to provide the necessary care for Resident 16 by not reducing the risk of potential decline and not maintaining the highest practicable physical well-being of each resident when it failed to monitor Resident 10's blood pressure on March 2, 2001, failed
to notify the oncoming shift of the elevated blood pressure level, and failed to contact Resident 10's doctor.
Resident 16 was admitted to Plantation Bay on February 10, 2001, following hospitalization for hepatic encephalopathy, secondary to cirrhosis of the liver, seizures, and falls. As a result of hepatic encephalopathy, the liver
is unable to remove all the ammonia that it produces, and there is a risk that some ammonia will be introduced into the heart and brain. Prior to his admission to the hospital, Resident 16's ammonia level was 96. When Resident 16 was admitted to Plantation Bay, the ammonia level was 33, which is within normal range.
Production of stool is important to reduce the absorption of nitrogen into the intestinal tract. On February 11, 2001, Resident 16's physician ordered 30 milligrams of Lactulose to be administered three times daily to produce at least three stools daily and to prevent hepatic encephalopathy. Plantation Bay administered the Lactulose to Resident 16 as ordered by the resident's doctor.
According to Resident 16's Documentation Charting Record, the order text on February 10, 2001, was to "Monitor BMs & chart daily with O-S-M-L." Plantation Bay did monitor Resident 16's bowel movements and prepared a daily chart on the number and size of the bowel movements. Plantation Bay was not required to
call the doctor if Resident 16 did not have three bowel movements a day.
On February 11, 2001, Resident 16 had two bowel movements and one bowel movement on February 12, 2001. Blood
tests on February 12, 2001, revealed that Resident 16 had an elevated ammonia level of 77, which is 17 points higher than normal. Plantation sent the test results to Resident 16's physician. The policy of Plantation Bay was to also place a copy of a laboratory report in the resident's chart. Resident 16's doctor went to the facility to see Resident 16 on February 13, 2001. The doctor did not change Resident 16's dosage of Lactulose nor did he make any notation about the number of Resident 16's bowel movements in the physician's notes.
The charting records for Resident 16 show that from February 13 through March 15, there were 13 days when Resident
16 had no bowel movements, ten days in which Resident 16 had one bowel movement, five days in which Resident had two bowel movements, and one day in which there were three bowel movements.
On April 5, 2001, Resident 16's physician stated in the Physician's Progress Notes for Resident 16 that Resident 16's ammonia levels had been fluctuating for four years, this was a chronic condition, and the fluctuation had nothing to do with the nursing care provided by Plantation Bay. He indicated that the ammonia levels were only a marker of the resident's condition. The nursing care provided by Plantation Bay did not cause the fluctuation in Resident 16's ammonia
level and that the nursing staff followed the orders of the doctor in administering the Lactulose, monitoring the bowel movements, and charting the bowel movements daily.
AHCA alleged under Tag F332 that Plantation Bay violated 42 CFR Section 483.25(m)(1), which requires that the facility is to be free of medication error rates of five percent or greater. AHCA contends that during the March 15, 2001, survey Plantation Bay had a medication error rate of
10.8 percent during observations of med passes on March 13, 2001. AHCA contends that during the April 19, 2001, survey that Plantation Bay had a medication error rate of 11.6 percent.
In determining if a medication error has occurred, the surveyors observe a nurse as medications are administered to a resident, and then will look at the physician's orders to see if the medications are administered in accordance with the physician's orders. If a medication is administered but not ordered, it is counted as a medication error. If a medication is ordered but not administered, it is counted as a medication error. If a medication is not administered in accordance with the physician's order, it is also counted as a medication error. The errors are counted regardless of how significant they might be.
The two AHCA surveyors who did the med pass
observations for Tag F332 had extensive training in surveying and followed the procedures for surveying violations of Tag F332 as set forth by the Health Care Financing Administration (HCFA) in the Guide to Surveyors and Task E of the survey protocols, which provides:
Initially observe a minimum of 20-25 opportunities for errors (opportunities are both the drugs been administered and the doses ordered but not administered).
Strive to observe as many individuals administering medications as possible. This provides a better overall picture of the accuracy of the facility's entire drug distribution system. Ideally, the medication observation could include residents representative of the care needs in the sample, or the actual sampled residents. This would provide additional
information on these residents, and provide a more complete picture of the care they actually receive. For example, if blood sugars are a problem, insulin administration may be observed. If eye infections are a problem, antibiotic eye drops may be observed, if residents are in pain, as needed pain medications may be observed, etc. Observe different routes of administration (i.e., eye drops, injections, NG administration, inhalation). If you found no errors after reconciliation of the pass with the medical records, this task is complete. If you found 1 or more errors, observe another 20 to 25, opportunities.
The error rate is calculated by taking the number of errors observed and dividing it by the opportunities for errors and multiplying by 100.
During the March 15, 2001, survey, an AHCA surveyor
observed two medication errors during medication pass out of
24 opportunities for administration of medicine. These errors were the administration of 220 milligrams of iron when
325 milligrams were ordered and the administration of
25 milligrams of Colace when 100 milligrams were ordered.
Colace is a stool softener.
During the March 15, 2001, survey, another AHCA surveyor observed three errors out of 22 opportunities for administration of medicine. These errors were the omission of
20 milligrams of Pepcid to be administered once daily, the administration of 500 milligrams of Vitamin C when there was no physician's order, and the administration of two drops of Tobra Dex Opthalmic eye drops when one drop was ordered by the physician.
During the April 19, 2001, survey an AHCA surveyor observed five errors out of 43 opportunities. These errors were failure to give Maalox with ibuprofen as ordered, administration of one drop of Gentamycin sulphate when two drops were ordered, administration of a multivitamin without iron when one with iron was ordered, administration of 1.20 milligrams of Prozac when 1.25 milligrams were ordered, and giving Lactolose after breakfast at 9:20 a.m. when it was ordered to be given before breakfast at 7:00 a.m.
Plantation Bay challenges the methodology used by
AHCA to determine the medication error rate. Plantation Bay's expert witness opined that a larger sampling would have to be used in order to get a more statistically valid error rate.
According to their expert, a sampling of over 3,000 opportunities would be necessary in order to reach an error rate which was 80 percent correct. No evidence was presented to show the number of opportunities for administration of medications that the facility had in a day. Thus, it is not known if the facility even had 3,000 opportunities a day. The evidence failed to support Plantation Bay's expert's opinion that over 3,000 opportunities would have to be observed in order to accurately determine the medication error rate for Plantation Bay is credible.
Contrary to the assertion of AHCA that the purpose of the med pass observations is to get a snap shot of one moment in time for the opportunities actually observed and not to make a projection as to what the error rate is for all the medication administrations in the building, Task E of the survey protocols makes it clear that the purpose of the med pass observations is to get a better "overall picture of the accuracy of the facility's entire drug distribution system." However, that error rate is obviously limited to the time of the survey.
Given the short time period in which a survey is
conducted, the methodology that is used to determine the medication error rate of the facility at the time of the survey is not fatally flawed. If the surveyor finds that an error occurs in observing the first 20 to 25 opportunities, the surveyor is to observe further opportunities to ascertain if there are errors in that group of observations.
For the March 15, 2001, survey, Plantation Bay had a medication error rate of 10.8 percent. For the April 19, 2001, survey, Plantation Bay had a medication error rate of
11.6 percent.
The Conditional Rating was effective from March 15, 2001, to June 11, 2001. No evidence was presented to establish when Plantation Bay was re-evaluated and a determination made that medication error was less than five percent.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of this proceeding. Sections 120.569 and 120.57, Florida Statutes.
AHCA is authorized to license nursing home facilities in the State of Florida, and pursuant to Chapter 400, Part II, Florida Statutes, is required to evaluate
nursing home facilities and assign ratings. Section 400.23(7), Florida Statutes, requires AHCA to "at least every
15 months, evaluate all nursing home facilities and make a determination as to the degree of compliance." AHCA's evaluation must be based on the most recent inspection report, taking into consideration, findings from official reports, surveys, interviews, investigations, and inspections. AHCA must assign either a Standard or Conditional rating to each facility after it surveys the facility.
Section 400.23, Florida Statutes.
Tag F224 incorporates the standard contained in 42 CFR Section 483.13(c), which provides that "[t]he facility must
develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents."
Tag F309 incorporates the standard contained in 42 CFR Section 483.25, which provides, "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care."
Tag F332 incorporates 42 CFR Section 483.25(m)(1), which provides that "[t]he facility must ensure that . . .[i]t
is free of medication error rates of five percent or greater."
The above-cited provisions of the Code of Federal Regulations are made applicable to nursing homes in Florida pursuant to Rule 59A-4.1288, Florida Administrative Code.
Section 400.23(8)(b), Florida Statutes, defines Class II deficiencies as "those which the agency determines have a direct or immediate relationship to the health, safety, or security of the nursing home facility residents, other than Class I deficiencies." Rule 59A-4.128, Florida Administrative Code, further defines Class II deficiencies as "those deficiencies that present an immediate threat to the health, safety, or security of the residents of the facility."
Section 400.23(8)(c), Florida Statutes, defines Class III deficiencies as "those which the agency determines to have an indirect or potential relationship to the health, safety or security of the nursing home facility residents, other than
class I or class II deficiencies. Rule 59A-4.128(3)(b), Florida Administrative Code, further defines Class III deficiencies as "those which present an indirect or potential relationship to the health, safety or security of the nursing home facilities, other than class I or class II deficiencies."
AHCA cited Plantation Bay for violations of 42 CFR
Section 483.13(c) and 42 CFR Section 483.25 for the same facts involving Resident 10. This attempt by AHCA to make two violations out of the same set of facts has been considered and rejected by the Department of Appeals Board. In Haverhill Care Center v. HCFA, Departmental Appeals Board Decision
No. CR522 (March 10, 1998), available at http://www.os.dhhs.gov/progorg/dab/, the administrative law judge made clear that Tag F224 was not an appropriate place for the agency to cite quality of care concerns such as the one at issue in this case:
This regulation is directed against medically unnecessary use of restraints, abuse, corporal punishment, involuntary seclusion, mistreatment, neglect, and misappropriation of property. This regulation is not meant to address every type of policy or procedure which addresses resident care. [This] Resident's situation is actually a question of compliance with a general nursing standard
of care, which is better addressed under
42 CFR [Section]483.25 Quality of Care.
Thus, in the instant case Resident's care should be addressed under Tag F309 and not Tag F224. AHCA did not establish a violation of 42 CFR Section 483.13(c).
AHCA has established by a preponderance of evidence that Plantation Bay's actions relating to Resident 10's blood pressure level after the nurse took Resident 10's blood pressure on March 2, 2001, and found it to be elevated is a
violation of 42 CFR Section 483.25 and constitutes a Class II deficiency. The failure to monitor the blood pressure, to notify the oncoming shift of the elevated blood pressure, and to contact Resident 10's physician posed an immediate threat to the health of Resident 10. Plantation Bay argues that Resident 10 did not have a sustained elevated blood pressure so there was no immediate threat to Resident 10's health.
Plantation Bay misses the point. It is not known whether Resident 10 had a sustained elevated blood pressure because Plantation Bay did not monitor the blood pressure. It is known that on March 13, 2001, 11 days after Plantation Bay's nurse found Resident 10 to have an elevated blood pressure that Resident 10 had an elevated blood pressure which resulted in her being seen by her doctor and in her medication being increased. It is also known that the reason that Resident 10's blood pressure was taken on March 13, 2001, was the request of the AHCA surveyor to do so.
AHCA has failed to establish that Plantation Bay violated 42 CFR Section 483.25 as it related to Resident 16.
AHCA has established that Plantation Bay violated
42 CFR Section 483.25(m)(1) during the March 15, 2001, survey and the April 19, 2001, survey by having medication error rates of five percent or greater. These violations constitute
Class III deficiencies. The Class III deficiency was not corrected at the time the facility was re-evaluated on April 19, 2001.
Section 400.23(7)(a), Florida Statutes, defines a Standard rating as follows:
A standard licensure rating means that the facility has no class I or class II deficiencies, has corrected all class III deficiencies within the time established by the agency, and is in substantial compliance at the time of the survey with criteria established under this part . . .
.
Section 400.23(7)(b), Florida Statutes, defines a Conditional rating as follows:
A conditional rating 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 the criteria established under this part "
AHCA has established that Plantation Bay should be given a Conditional license as a result of the Class II deficiency that was found during the March 15, 2001, survey.
AHCA has established that Plantation Bay should be given a Conditional license as a result of the uncorrected Class III deficiency found during the April 19, 2001, survey.
Plantation Bay argues that because no evidence was presented that the Class III deficiency existed beyond the April 19, 2001, survey date, the Conditional license should be only for April 19, 2001. Plantation Bay's argument is without merit. A Conditional rating based on an uncorrected Class III deficiency continues until the facility is re-evaluated and found to have corrected the Class III deficiency. Rule 59A- 4.128, Florida Administrative Code. If AHCA continued the Conditional rating past the time Plantation Bay was re- evaluated and found to have corrected the Class III deficiency, Plantation Bay could have raised that issue as an affirmative defense, which it did not do.
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Plantation Bay receive a Conditional license from March 15, 2001, through June 11, 2001.
DONE AND ENTERED this 2nd day of November, 2001, in Tallahassee, Leon County, Florida.
___________________________________
Susan B. Kirkland Administrative Law Judge Division of Administrative
Hearings
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
this 2nd day of November, 2001.
COPIES FURNISHED:
Patricia J. Hakes, Esquire
Agency for Health Care Administration
525 Mirror Lake Drive, North Room 310J
St. Petersburg, Florida 33701
R. Davis Thomas, Jr. Qualified Representative Broad and Cassel
215 South Monroe Street, Suite 400 Post Office Box 11300
Tallahassee, Florida 32302-1300
Diane Grubbs, Agency Clerk
Agency for Health Care Administration 2727 Mahan Drive
Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive
Fort Knox Building, Suite 3431 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 |
---|---|---|
Mar. 20, 2002 | Agency Final Order | |
Nov. 02, 2001 | Recommended Order | Nursing home had Class II deficiency with Tag F309 and uncorrected Class III deficiency with Tag F332. Recommend Conditional license from March 15, 2001 through June 11, 2001. |