STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE ADMINISTRATION,

Petitioner,

vs.

BEVERLY HEALTHCARE ROSEMONT,

Respondent.

)

)

)

)

) Case No. 01-1982

)

)

)

)

)

)

RECOMMENDED ORDER

A formal hearing was held in this case before Jeff B. Clark, Administrative Law Judge, Division of Administrative Hearings, on September 10, 2001, in Orlando, Florida.

APPEARANCES

For Petitioner: Patricia J. Hakes, Esquire

Paul Lauve, 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 Drawer 11300 Tallahassee, Florida 32302

STATEMENT OF THE ISSUES

Whether Respondent, Beverly Healthcare Rosemont, was in violation of 42 C.F.R. Section 483, Chapter 400, Florida Statutes, and Rule 59A-4, Florida Administrative Code, at the

time of its annual survey from January 22 through 25, 2001, and, if so, whether those violations were uncorrected at the time of the follow-up survey on March 1, 2001, in order to justify the issuance of a Conditional License from March 1, 2001 until April 4, 2001.

PRELIMINARY STATEMENT

The Agency for Health Care Administration ("Petitioner") conducted an annual survey from January 22 through 25, 2001, and a follow-up survey on March 1, 2001, of Beverly Healthcare Rosemont ("Respondent").

Based on these survey results, and pursuant to Subsection 400.23(7)(b), Florida Statutes, the facility was

assigned a conditional licensure rating effective March 1, 2001, which continued until the facility's receipt of a Standard License on April 4, 2001. The conditional rating was based on Petitioner's determination that Respondent had deficiencies in the first survey and that three of these deficiencies were uncorrected in the second survey; these deficiencies were assigned Tags F164, F332, and F465.

On April 9, 2001, Respondent filed a petition under Section 120.57, Florida Statutes, challenging the Conditional License and, on May 18, 2001, this matter was referred to the Division of Administrative Hearings. On June 8, 2001, the case was set for final hearing on July 30, 2001. On a Joint Motion

for Continuance the case was reset for final hearing on September 10, 2001. At the hearing Petitioner presented testimony of four witnesses: Michelle Dillehay, R.N.; Theresa Decamio, R.N.; Sue O'Brien, R.N.; and Linda Raveling, R.N., by deposition dated September 5, 2001, and offered eight exhibits (Petitioner's Exhibits 1-8) which were admitted into evidence. Respondent presented one witness, Chana Tarpley, and three exhibits; Respondent's Exhibits 1 and 2 were admitted into evidence at the hearing. Respondent's Exhibit 3, consisting of four pages of March 1 through 31, 2001, Physician Orders Sheets, was admitted into evidence after the hearing.

A Transcript of the hearing was filed on September 28, 2001. The parties filed a motion for extension of time to file their post-hearing submittals; the motion was granted. Both parties filed Proposed Recommended Orders which were given careful consideration in the preparation of this Recommended Order.

FINDINGS OF FACT

1. Respondent is a licensed nursing home in Orlando, Florida.

2. Pursuant to Chapter 400, Florida Statutes, Petitioner surveys Respondent to determine whether it is in compliance with applicable laws and regulations. If there are deficiencies, it determines the level of deficiency. When Petitioner conducts a

   survey of a nursing home, it issues a survey report, commonly referred to by its form number, a "2567." The particular regulation, and the allegedly deficient practices which constitute a violation of that regulation, are cited in a column on the left side of the paper. After receiving the 2567, the facility is required to develop a plan of correction of the alleged deficiency which is put in the right hand column of the 2567 corresponding to the alleged deficiency. The facility is required to develop this plan of correction regardless of whether it agrees that it is in violation of any regulations, and it is prohibited from being argumentative in the 2567.

3. Petitioner conducted its annual survey of Respondent from January 22 through 25, 2001, and issued a 2567 survey report noting certain deficiencies. The deficiencies are designated as tag numbers. Among those noted were Tag F164, which is the shorthand reference to, and which incorporates

   1. C.F.R. Subsection 483.10(e); Tag F332, which refers to and incorporates 42 C.F.R. Subsection 483.25(m)(1); and Tag F465, which refers to and incorporates 42 C.F.R. Subsection 483.70(h). Petitioner rated these deficiencies as Class III deficiencies. By assigning the deficiencies that rating, Petitioner maintained that each deficiency presented "an indirect or potential relationship to health, safety and security of nursing home residents."

4. Petitioner conducted a follow-up survey on March 1, 2001, and determined that the deficiencies under Tags F164, F332, and F465 were uncorrected, and, as a result, issued a conditional rating to the facility. The conditional rating continued until April 4, 2001, when Petitioner changed it to a standard rating.

5. The 2567 constitutes the charging document for purposes of issuing a Conditional License. No other document was offered to describe the offenses, or deficiencies, which resulted in imposition of the Conditional License.

6. In conducting its survey, Petitioner uses a document developed by the Health Care Financing Administration ("HCFA"), called the State Operations Manual. It provides guidance on how to interpret regulations.

   TAG F164

   
   

7. The 2567 from the January survey asserts, under

   
   

   Tag F164 which incorporates 42 C.F.R. Subsection 483.10(e), that the facility "failed to protect the right to privacy and confidentiality of residents' clinical records regarding meal intake and medications." The regulation states that residents have "the right to personal privacy and confidentiality of his or her clinical records."

8. During the January survey, Petitioner's surveyor observed a nurse leave the residents' medications chart on the

   medication cart while the nurse was administering medications to residents. The medications chart was open and could be examined by anyone passing in the hallway. The surveyor believed that there was a potential that these confidential medications records could be seen by unauthorized third persons and therefore assigned the F164 deficiency.

9. During the follow-up survey on March 1, 2001, the surveyor observed that the medication charts were no longer open and that particular "problem" had been corrected.

10. However, during the March 1, 2001, follow-up survey, the surveyor noted a nurse performing an "Acu-check" test on Resident 16 in the hallway in the presence of three other residents. She also observed a nurse giving an insulin injection to Resident 17 in her abdomen in the hallway in the presence of residents. As a result of these observations, the surveyor believed that these residents' right to personal privacy in medical treatment was not being maintained and that the deficiencies identified as Tag F164 continued.

11. The surveyor acknowledged that both residents could consent to the administration of treatment in the manner that was observed and, in the event they consented, their right to privacy in medical treatment would be preserved. She failed to inquire of the residents or the nurse as whether they had consented to the critical treatment.

12. The Respondent's nurse/witness testified that Resident 17 is a retired nurse, is cognitive, and has previously requested that her insulin injection be given in the manner described by the surveyor. She further described giving the "Acu-check" test as described by the surveyor to Resident 16, who is cognitive, on other occasions, without Resident 16's objecting. She testified that the standard practice is to take the resident out of the resident population into the resident's room or some other private place to administer treatment.

    TAG F332

    
    

13. Petitioner charged in the 2567 for the January 2001 survey that Respondent exceeded the minimum prescribed level of error rate in medication administration. Tag F332, which incorporates 42 C.F.R. Subsection 483.25(m)(1), provides that "the facility must ensure that it is free of medication error rates of five percent or greater."

14. During the January 2001 survey, the surveyors observed "the medication pass on the North and South wings with 6 nurses identified 5 errors out of 48 opportunities revealing a

    10.4 percent medication error rate."

    
    

15. Because it is impossible, as a practical matter, to observe the administration of all medication while conducting a survey, the protocol to determine the accuracy of medication administration is based on representative sampling. The

    surveyor will observe approximately 20 medication administrations (also called "opportunities for error"). If an error in administration is observed, 20 or so more administrations are observed. The surveyor will then project the facility's medication error rate based on the percentage determined by dividing the number of errors by the number of administrations.

16. During the March 1, 2001, follow-up survey, the surveyor observed three errors in the first 20 or so medication administrations. She then observed 20 more administrations which were error free. There were a total of three errors in

    1. administrations; the result was an error rate of 6.9 percent which exceeded the minimum standard; had only two errors been observed the error rate would be an acceptable 4.6 percent.

17. Failure to follow the physician's orders, failure to follow manufacturer's specifications, and not following accepted standards of practice are the most common medication administration errors. Both significant and insignificant errors are counted to determine error rate.

18. During the March 1, 2001, follow-up survey, the three alleged medication administration errors were: (1) a nurse gave a resident Gentamicin, an antibiotic eye drop, in both eyes when the surveyor believed the Physician Orders called for administration in one eye; (2) a nurse was observed giving a

    resident 330 mg. of ferrous elixir when the Physician Orders called for 325 mg.; and (3) a nurse was observed giving a resident two Tylenol tablets when the surveyor believed that the Physician Orders called for only one Tylenol tablet.

19. The surveyor believed the administration of Tylenol was a medication error because it did not follow the Physician Orders that read: "8/1/00, Meds, Q8Hr, Tylenol Tabs, 325 mg, (Acetaminophen/325 mg) Oral, Q8Hrs." Although the order reads "Tabs," it does not quantify the number of "Tabs" to be administered. The physician who prescribed the medication was not interviewed. The surveyor believed the indication "325 mg" limited the amount of dosage although it is acknowledged that this is a standard size Tylenol and that the therapeutic dosage is two tabs. The same Physician Orders has an entry that reads "10/12/99, Meds, Q4Hp, Tylenol caplets, 325 mg,(Acetaminophen/

    325 mg), For Temperature > 101 or C/O minor discomfort. 2 Oral as needed, q4H."

20. The Physician Orders written on February 23, 2001, indicated "Gentamycin [sic] ophthalmic solution 1 gtt (drop) TID (three times a day) for 7 days." It is not possible to determine from the Physician Orders that a medication error had occurred. The surveyor's determination that the Gentamicin ophthalmic solution was improperly administered was based on the hearsay statement of a resident and additional documentary

    evidence not offered at the hearing and, therefore, is not accepted as credible.

    TAG F465

    
    

21. Petitioner charges in the 2567 from the January 2001 survey, that Respondent violated 42 C.F.R. Subsection 483.70(h) in that it failed to "provide a safe, functional, sanitary, and comfortable environment for residents, staff, and the public." The basis for this violation was: "[D]uring the initial tour of the facility on 1/22/01 on the South wing at approximately 10:00 a.m., several resident rooms had dirty linen on the floors in the rooms and bathrooms. Dirty towels, washcloths, and sheets were observed on the floor." Testimony revealed that these conditions were observed in four rooms on the first day and in one room on a later day.

22. During the follow-up survey it was noted that this offending practice had been corrected. Testimony revealed that the procedure for the disposition of dirty linen, gowns, towels and washcloths was to place them in a hamper for transportation to the laundry.

23. During the March 2001 follow-up survey, it was noted that "at 4:30 p.m., a caddie with toilet cleanser, a toilet brush, antibacterial hand cleaner and furniture polish was observed on a resident's overbed table in room #203." The surveyor observed this to be in violation of 42 C.F.R.

    Subsection 483.70(h), as it did not provide a safe environment for residents.

24. The caddie was removed immediately after its discovery.

    CONCLUSIONS OF LAW

    
    

25. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this cause, pursuant to Section 120.569 and Subsection 120.57(1), Florida Statutes.

26. Subsection 120.569(1), Florida Statutes, applies to all proceedings in which the substantial interests of a party are determined by an agency. Subsection 120.57(1), Florida Statutes, applies in those proceedings involving disputed issues of material fact.

27. A facility is substantially affected by a conditional rating and/or an administrative fine. For example,

    Section 408.035, Florida Statutes, governing 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 thirty months; Section 400.235, Florida Statutes. A conditional rating can substantially affect the reputation of a facility in the community and have a negative impact on staff

    morale and recruiting. Spanish Gardens Nursing & Convalescent Center (Beverly Health & Rehab Svcs., Inc.) v. Agency for Health

    Care Administration, 21 FALR 132 (AHCA, 1998).

    
    

28. Petitioner is authorized to license nursing home facilities in the State of Florida, and pursuant to Chapter 400, Part II, Florida Statutes, is required to "at least every

    15 months, evaluate all nursing home facilities and make a determination as to the degree of compliance "

    Petitioner's evaluation must be based on the most recent inspection report, taking into consideration findings from other official reports, surveys, interviews, investigations and inspections. It must assign either a standard or conditional licensure rating to each facility after it is surveyed.

    Subsection 400.23(7)(b), Florida Statutes.

    
    

29. Subsection 400.23(7)(b), Florida Statutes (2000), provides:

    [C]onditional 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, . . . . If the facility comes into substantial compliance at the time of the follow-up survey, a standard licensure status may be assigned.

    
    

30. Subsection 400.23(8)(c), Florida Statutes (2000), provides:

    Class III deficiencies are those which the agency Respondent determines to have an indirect or potential relationship to the health, safety or security of nursing home facility residents, other than class I and class II deficiencies. A class III deficiency shall be subject to a civil penalty . . . for each and every deficiency.

    . . .

    
    

31. Conditional licensure is authorized by law for facilities with Class III deficiencies which are not corrected. Subsection 400.23(7)(b), Florida Statutes.

32. Tag F164 incorporates 42 C.F.R. Subsection 483.10(e) which states: "Privacy and confidentiality. Each resident has the right to personal privacy of his or her personal and clinical records. (1) Personal privacy includes accommodations, medical treatment, written and telephone communications, personal care, visits, and meetings of family and resident groups "

33. Tag F332 incorporates 42 C.F.R. Subsection 483.25(m)(1) which states: "Medication Errors--The facility must ensure that--(1) It is free of medication error rates of 5 percent or greater."

34. Tag F465 incorporates 42 C.F.R. Subsection 483.70(h) which states: "Other environmental conditions. The facility must provide a safe, functional, sanitary, and comfortable environment for residents, staff and the public."

35. Petitioner has the burden of proving by a preponderance of the evidence the basis of changing Respondent's licensure rating to conditional and the basis for imposing an administrative fine. Florida Department of Transportation v. J.W.C. 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 1977).

    
    

36. In the instant case, Petitioner alleges that it was proper to issue Respondent a Conditional License on

    March 1, 2001, because Class III deficiencies cited in the January survey were allegedly uncorrected at the time of the March survey. Under Section 400.23, Florida Statutes, a Conditional License can be imposed for Class III deficiencies only if they are not corrected within the time frame established by Petitioner. Accordingly, it is Petitioner's burden to establish by at least a preponderance of evidence the existence of the deficiencies cited by the surveys of both January and March 2001.

37. Respondent is entitled to a succinct and understandable statement of the charges. See Cottrill v. Department of Insurance, 685 So. 2d 1371, 1372 (Fla. 1st DCA 1996). As the charges are made through the 2567, the allegations of that document are what must be proven, and what Respondent is required to defend.

38. The charges made by Petitioner in the 2567 from the January 2001 survey under Tag F164 relate to privacy and confidentiality of personal and clinical records. The staff oversight in leaving the medications records open and available to public scrutiny on the medications cart was corrected at the time of the March 2001 follow-up survey. The administration of medication in a non-private setting observed during the March 2001 re-survey allegedly is violative of the same C.F.R. Subsection incorporated by Tag F164. The surveyor failed to ascertain if either of the residents had consented to the non- private treatment; evidence was presented indicating that one resident had requested the public administration of insulin and the other had never objected the particular test being administered in the presence of other residents. Petitioner has failed to demonstrate by a preponderance of evidence that the two cited residents' right to privacy in medical treatment has been violated.

39. Petitioner's assertion that Respondent did not fulfill its "plan of correction" as it relates to Tag F332 is similarly not proven. Of the three asserted errors in the March 2001 follow-up survey of medication passes only one is proven by a preponderance of the evidence. Based on the evidence presented, the administration of two Tylenol tabs and the placement of

    Gentamicin ophthalmic solution in both eyes appear to follow Physician Orders. The miscalculation and administration of

    5 mg. of ferrous elixir while an apparent small error is, none the less, an error. One error in 43 medication passes/error opportunities is less than 5 percent and, as a result, Respondent did not exceed the 5 percent error rate during the March 2001 follow-up survey.

40. Petitioner charges, under Tag F465 in the January 2001 survey that Respondent violated 42 C.F.R. Subsection 483.70(h) because of the apparent widespread practice of stripping beds and throwing sheets, gowns, towels and washcloths on the floor for later collection and transfer to the laundry. This purportedly created both an unsafe and unsanitary condition in resident rooms. This practice had been corrected and a new procedure was in place by the March 2001 follow-up survey. However, during the March 2001 follow-up survey, a caddie containing apparently noxious chemicals was discovered unattended and accessible to residents. This incident is the basis for the Petitioner's determination that this Tag, which addresses providing a safe environment for residents, continued as "uncorrected." Unquestionably, leaving noxious chemicals accessible to residents presents an unsafe situation and a foreseeable risk of harm to residents.

RECOMMENDATION

Based of the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that the Agency for Health Care Administration enter a final order revising the March 1, 2001, survey report by deleting the deficiencies described under Tags F164 and F332, but confirming the existence of an uncorrected deficiency, Tag F465, and assigning a Conditional License to Respondent for the period March 1, 2001 to April 4, 2001.

DONE AND ENTERED this 30th day of November, 2001, in Tallahassee, Leon County, Florida.

JEFF B. CLARK

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 30th day of November, 2001.

COPIES FURNISHED:

Patricia J. Hakes, Esquire Paul Lauve, Esquire

Agency for Health Care Administration

525 Mirror Lake Drive, North Room 310J

St. Petersburg, Florida 33701

R. Davis Thomas, Jr., Esquire Broad and Cassel

215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302

Diane Grubbs, Agency Clerk

Agency for Health Care Administration 2727 Mahan Drive

Fort Knox Building Three Suite 3431

Tallahassee, Florida 32308

William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive

Fort Knox Building Three 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.

Docket for Case No: 01-001982

Orders for Case No: 01-001982