Department of Health and Human Services

DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

In the Case of:

Golden State Manor Nursing
and Rehabilitation Center, DATE: February 28, 1996
Petitioner,

Docket No. C-94-364
Decision No. CR412

-v-

Health Care Financing
Administration.

DECISION

This case is before me on Petitioner's request for an
administrative law judge hearing on the determination by
the Health Care Financing Administration (HCFA) that
January 31, 1994 should be the effective date of
Petitioner's participation as a Medicare provider. I
sustain HCFA's determination.

An initial Medicare survey of Petitioner was conducted on
December 14-23, 1993, for purposes of determining whether
Petitioner could be certified as a Medicare provider of
skilled nursing services. As a result of this survey,
HCFA informed Petitioner that deficiencies were
identified which evidenced a lack of full compliance with
the requirements of 42 C.F.R. Part 483.

On January 31, 1994, Petitioner submitted its plan of
correction. By letter dated February 23, 1994, HCFA
notified Petitioner that it was certifying Petitioner as
a provider in the Medicare program, effective January 31,
1994, the date of Petitioner's acceptable plan of
correction. HCFA Exhibit (Ex). 5.!

' HCFA subsequently issued an amended letter
dated February 28, 1994, to Petitioner. The only change
from the earlier letter dated February 23, 1994, is that
a different fiscal intermediary is named. HCFA Ex. 6.

(continued...)
2

Petitioner requested, and was granted, reconsideration of
HCFA's determination of its effective date of Medicare
participation. HCFA Ex. 7. By letter dated March 25,
1994, HCFA reaffirmed its earlier decision to certify
Petitioner as of January 31, 1994. HCFA Ex. 8.
Petitioner again requested that HCFA reconsider its
determination.

By letter dated May 6, 1994, HCFA reaffirmed its decision
to accept Petitioner's agreement to participate in the

1 (...continued)

HCFA submitted HCFA Exs. 1-15. Petitioner submitted
Petitioner's Exhibits (P. Exs.) 1-4, 9-10, 19-32, 34-36,
41, 43-53. At the hearing, I admitted HCFA Exs. 1-15 and
P. ExsS. 1-4, 9-10, 19-32, 34-36, 41, 43-48, and 50-53
into evidence. I rejected P. Ex. 49. Petitioner
provided a list with its opening posthearing brief
stating the exhibits which were admitted in this case.
Upon examining Petitioner's list and carefully checking
the record, I have determined that Petitioner's list is
inaccurate.

The parties' posthearing briefs, the transcript of the
hearing, and my findings of fact and conclusions of law
will be cited as follows:

Transcript of Hearing Tr. (page)
HCFA's Opening Posthearing HCFA Br. at (page)
Memorandum
Petitioner's Posthearing P. Br. at (page)
Brief
HCFA's Posthearing Response HCFA Resp. Br. at
(page)
Petitioner's Opposing Brief P. Resp. Br. at (page)
(to HCFA's Opening Post-Hearing
Memorandun)
HCFA's Posthearing Reply HCFA Rep. Br. at
(page)
Petitioner's Reply Brief to P. Rep. Br. at (page)

HCFA Post-Hearing Response

My Findings of Fact and FFCL (number)
Conclusions of Law
3

Medicare program effective January 31, 1994. HCFA Ex. 9.
By letter dated May 13, 1994, Petitioner requested a
hearing to contest HCFA's determination. The case was
assigned to me for a hearing and a decision.

On December 15, 1994, I issued a Ruling on Subpoena
Requests, the purpose of which was to decide Petitioner's
written requests, filed on September 13, 1994, for the
issuance of subpoenas for the production of the
surveyors! notes. In this ruling, I found Petitioner's
justification for the subpoena requests to be inadequate
and insufficient to satisfy its burden under the
regulations and applicable case precedent. Furthermore,
I ruled that the surveyors' notes are part of the
deliberative process and were protected from disclosure
by the deliberative process privilege.

On January 17-20, 1995, I conducted an in-person hearing
in San Diego, California. Because the hearing did not
conclude on January 20, I continued it to March 6, 1995.
On March 6-10, 1995, I conducted the remainder of the in-
person hearing in San Diego, California. The parties
filed posthearing briefs, followed by posthearing
response briefs and reply briefs.
4
I. Findings of Fact and Conclusions of Law?
1. Petitioner is a skilled nursing facility, with

approximately 300 beds, located in San Diego, California.
Tr. 1644.

2. The San Diego District Office of Licensing and
Certification, California Department of Health Services
(DHS) is authorized to perform surveys of skilled nursing
facilities in order to make recommendations to HCFA on
whether such facilities meet the federal requirements for
participation in the Medicare program. 42 U.S.C. §
1395aa(a).?

3. The Medicare survey of Petitioner began on December
14, 1993 (Tr. 1590-1592) and was completed on December
23, 1993 (Tr. 109).

4. Although the State surveyors found Petitioner to be
in compliance with all Level A requirements imposed by
HCFA for skilled nursing facilities, there were numerous
Level B deficiencies identifie at the time of the
survey. HCFA Ex. 2.

5. Title XVIII of the Social Security Act, 42 U.S.C. §§
1395 et seq., commonly known as the Medicare Act,
establishes a federally subsidized health insurance

2 FFCL 1-10 are HCFA's Proposed Findings of Fact
and Conclusions of Law 1, 2, 7-8, 28-30, and 32-34, which
I have adopted, in pertinent part. Petitioner did not
object to these specific findings of fact and conclusions
of law and, thus, I am adopting them. Where necessary
for purposes of clarity and consistency of style, I have
made editorial changes, which do not alter the substance
of the findings.

Although there were other proposed findings of fact and
conclusions of law submitted by HCFA to which Petitioner
did not object, I have chosen not to adopt them.

I have made my own findings of fact and conclusions of
law based on my independent review of the record, and
these are set forth beginning at FFCL 11.

3 Hereinafter, I refer to the San Diego District
Office of Licensing and Certification as "DHS-San Diego."
5

program for the elderly and disabled which is
administered by the Secretary of Health and Human
Services (the Secretary).

6. The Secretary has delegated to HCFA the
responsibility for carrying out many of the duties under
this program.

7. Skilled nursing facilities or other entities may
participate in the Medicare program by entering into a
"provider agreement" with the Secretary. 42 U.S.C. §§
1395x(u) and 1395cc.

8. The results of Medicare related surveys are used by
HCFA as the basis for its decisions regarding a
facility's initial or continued participation in the
Medicare program.

9. The findings of State agencies are recommendations to
HCFA, which makes the actual determination as to whether
a facility is eligible to participate or to remain in the
program. 42 C.F.R. § 489.10.

10. Onsite inspections (surveys) of facilities must be
conducted without any prior notice to the facility. See
42 U.S.C. § 1395i-3(g) (2) (A).

11. A skilled nursing facility is defined as an
institution which is primarily engaged in providing
skilled nursing care and related services for residents
who require medical or nursing care, or rehabilitation
services for the rehabilitation of injured, disabled, or
sick persons, and is not primarily for the care and
treatment of mental diseases. 42 U.S.C. 1395i-3(a).

12. A skilled nursing facility must meet also the
requirements of 42 U.S.C. 1395i-3(b), (c), and (da).

13. On December 14-23, 1993, Petitioner was surveyed on
behalf of HCFA by surveyors from DHS-San Diego. The
purpose of the survey was to determine whether Petitioner
was conducting its operations in compliance with the
requirements of the Medicare program.

14. DHS-San Diego then issued to Petitioner a document
captioned "Statement of Deficiencies and Plan of
Correction" (HCFA 2567), which sets out the deficiencies
identified during the survey.

15. Petitioner was found to have failed to comply with
various regulations governing a skilled nursing
facility's participation in Medicare, and these were: 42
6

C.F.R. §§ 483.13(a); 483.15(h) (3); 483.20(b) (1);
483.20(b) (5); 483.20(b) (6); 483.20(c) (1); 483.20
483.230(a) (2) (ii); 483.20(d) (2) (iii); 483.20(d) (
483.25; 483.25(c) (2); 483.25(e) (2); 483.35(f) (3)
483.65(a) (1); 483.65(a) (3); 483.70(d) (1); and
483.75(1) (1).

(a) (1);
3)7

16. On January 31, 1994, Petitioner submitted its plan
of correction to DHS. HCFA Ex. 2.

17. By letter dated February 23, 1994, HCFA notified
Petitioner that it was certifying Petitioner as a
provider in the Medicare program, effective January 31,
1994, the date of Petitioner's acceptable plan of
correction. HCFA Ex. 5.

18. On February 28, 1994, HCFA sent an amended
notification letter (changing only the designation of
fiscal intermediary). HCFA Ex. 6.

19. HCFA reconsidered its determination at Petitioner's
request, but, by letter dated May 6, 1994, notified
Petitioner that it found no basis to alter its initial
determination. HCFA Exs. 7, 9.

20. Petitioner requested further review of the HCFA 2567
findings, and HCFA again reaffirmed its decision to
accept Petitioner's agreement to participate in the
Medicare program effective January 31, 1994. HCFA Ex.
10.

21. The survey team that conducted the December 14-23,
1993 survey of Petitioner consisted of Glenda Shekell,
Carol Pettengill, Cindy Cox, and Judith Chute. Tr. 85-
86, 1590.

22. At the time of the December 1993 survey, Petitioner
had 230 residents. Tr. 1644.

23. On December 23, 1993, the last day of the survey of
Petitioner, the survey team held an exit conference with
Petitioner's representatives. Tr. 103-104, 109.

24. Petitioner's representatives were briefed thoroughly
by the survey team on December 23, 1993. Tr. 2191.

25. Glenda Shekell is a health facility evaluator nurse
with DHS-San Diego. Tr. 79-80, 83-84.

26. Ms. Shekell has worked at DHS-San Diego since April
1988 and estimates that she has performed 200 surveys of
long-term care facilities. Tr. 80, 81-82.
7

27. Ms. Shekell's primary duty until April 1994 was to
conduct licensing and certification surveys of long-term
care facilities. Tr. 81.

28. Ms. Shekell was the team leader of the survey team
that performed the survey of Petitioner on December 14-
23, 1993. Tr. 84, 90.

29. At the time of the December 1993 survey, Ms. Jacqy
Downing was Ms. Shekell's supervisor. Tr. 87.

30. Cynthia Cox is a health facility evaluator nurse
with DHS-San Diego and has been at her current position
since January 1990. Tr. 990.

31. Ms. Cox estimated that she has participated in
approximately 150 certification surveys of skilled
nursing facilities. Tr. 991.

32. Ms. Cox stated that she received training in how to
conduct surveys and write deficiencies pursuant to HCFA's
regulations regarding Medicare certification for skilled
nursing facilities. Tr. 991.

33. During Ms. Cox's third year working at DHS-San
Diego, Ms. Downing became her supervisor and was her
supervisor until early 1994. Tr. 992, 993-994.

34. Martha Carrillo is a certification specialist with
the Provider Certification Unit of DHS-San Diego. fr.
921.

35. At the request of her supervisor, Ms. Carrillo
reviewed the HCFA 2567 to check the validity and accuracy
of the deficiencies, and whether the plan of correction
submitted by Petitioner was valid. Tr. 923-924.

36. Nelson Ford is a health facility evaluator
supervisor with DHS-San Diego and has been a supervisor
for three years. Tr. 1582-1583.

37. In his position as supervisor, Mr. Ford schedules
surveys and acts as a resource and consultant to survey
teams when they are conducting surveys. Tr. 1583-1584.

38. Since December 1992, one of the facilities assigned
to Mr. Ford has been Petitioner. Tr. 1585, 1592.

39. Dan Murray was employed as the hospital
administrator of Petitioner from December 1993 to
September 21, 1994. Tr. 2188, 2193.
8

40. Mr. Murray was in the facility during the time of
the December 1993 survey and spoke with the surveyors.
Tr. 2191.

41. Mr. Murray prepared most of Petitioner's Plan of
Correction and submitted it to HCFA on January 31, 1994.
Tr. 2190-2191.

42. Joan Allison is employed by the DHS as chief of
field operations for the southern region in the licensing
and certification program. Tr. 2735-2736.

43. DHS-San Diego is one of the offices in Ms. Allison's
region. Tr. 2736.

44, Ms. Allison participated in an internal
investigation in October and November 1993 involving the
San Diego DHS office. Tr. 2738-2739, 2781.

45. Ruth Patience, who has a nursing background, has
worked for HCFA for four years aS a survey and
certification review specialist. She is "responsible for
assisting and overseeing and managing the state agencies
who survey and certify health care facilities." Tr.
2436, 2437, 2439-2440.

46. Ms. Patience conducts surveys by which HCFA
evaluates the effectiveness of the state surveys and also
participates in training surveyors. Tr. 2437.

47. Ms. Patience estimated that, during her employment
with HCFA, she has participated in approximately 120
surveys of long-term care facilities. Tr. 2437-2438.

48. Prior to working for HCFA, Ms. Patience worked as a
state surveyor for a year and a half. Tr. 2438. Asa
surveyor, she surveyed about 60 long-term care
facilities. Id.

° Evaluation of the credibility of Jacgy Downing (pp. 35-
40)"

49. Ms. Downing is the "assistant administrator" of
Petitioner and a “registered nurse consultant for the
nursing department within the facility." Tr. 1687.

4 The pages cited in the parentheses refer to the
pages in the decision where these findings are discussed.
9

50. Ms. Downing was recruited to work for Petitioner by
Dan Murray and began working for Petitioner on January
17, 1994. Tr. 1687-1688, 2101.

51. Prior to her employment at Petitioner, Ms. Downing
worked for approximately six years at DHS-San Diego,
beginning in March 1988. Tr. 1688, 2066.

52. At DHS-San Diego, Ms. Downing was a surveyor for two
and a half years, and was promoted to health facility
evaluator supervisor on October 1, 1990. Tr. 1688, 1691,
2067.

53. Ms. Downing participated in approximately two to
three surveys a month when she was at DHS-San Diego. Tr.
1690.

54. When she was with DHS-San Diego, Ms. Downing
followed the State Operations Manual Transmittal No. 250
(SOM 250) guidelines after they were implemented in April
1991 and instructed her survey team to follow these
guidelines. Tr. 2130.

55. As a supervisor, Ms. Downing never referred to or
used the "Resident Assessment Instrument Training Manual
and Resource Guide" (P. Ex. 52), nor did her survey team
members use this manual. Tr. 2138.

56. P. Ex. 52 had not been disseminated as of January
1994, according to Ms. Downing. Tr. 2138.

57. Ms. Downing did not have supervisory
responsibilities over the survey team that conducted the
December 1993 survey of Petitioner. Tr. 1690, 2072,
2138.

58. Ms. Downing was not onsite at Petitioner during the
survey.

59. Following the survey of Petitioner, Ms. Downing did
not participate in writing any findings for the HCFA
2567. Tr. 1698.

60. In October and November 1993, Ms. Allison and Paul
Keller participated in an internal investigation
involving DHS-San Diego, the purpose of which was to
determine whether someone in that office had altered
complaint documents. Tr. 2738-2739, 2781.

61. Ms. Allison and Mr. Keller went to the San Diego
district office and interviewed the district manager, the
district administrator, all of the supervisors (including
10

Ms. Downing), and one of her surveyors, who allegedly
falsified the documents. Tr. 2740; see also Tr. 2755-
2756.

62. The investigation revealed that approximately 80
survey documents had been altered and that the falsified
documents had Ms. Downing's name "signed as the
supervisor." Tr. 2743.

63. The investigation revealed that Ms. Downing's name
was the only name signed as supervisor on all of the
falsified documents. Tr. 2743.

64. The investigation revealed that "Ms. Downing had
given specific directions to the surveyor in terms of how
to prepare these complaint documents including whiting
out the information and preparing the complaint documents
in that way. And then, subsequently, in approving and
sending forward all of these complaints as if they had,
in fact, been legitimately investigated." Tr. 2745.

65. Ms. Allison stated that no other supervisors were
the focus of the investigation. Tr. 2743.

66. DHS's audits and investigations division conducted a
second investigation, which confirmed the results of the
initial investigation. Tr. 2778-2779.

67. As a result of the investigation, DHS served both Ms.
Downing and the evaluator in December 1993 with an action
to dismiss from State service. Tr. 2746, 2756, 2759-
2760.

68. Prior to a State hearing, DHS and Ms. Downing
reached a stipulated agreement, which required Ms.
Downing to resign effective January 14, 1994. HCFA Ex.
14; Tr. 2746, 2758, 2779. A hearing did not take place.
Tr. 2758. Ms. Downing resigned in accordance with the
stipulated agreement. Tr. 2779.

69. Ms. Downing left the DHS on January 7, 1994. Tr.
2071.

70. Contrary to what actually occurred, Ms. Downing
testified under oath that:

a. She had no knowledge of problems regarding the
falsification of complaints in the office. Tr.
2074.
11

b. She "didn't have any clear understanding of what
the investigation was" (Tr. 2084), had no knowledge
that the focus of the investigation was that
complaint results were being reported which had not
been investigated, and was never informed of this by
any of the investigators. Tr. 2096.

c. She was not "personally confronted" with charges
concerning the investigation nor were any
allegations concerning any impropriety brought to
her attention during her interview with the
investigators. Tr. 2084, 2086-2087.

da. No one told her that the complaints at issue
originated out of her survey team. Tr. 2084.

e. The investigation did not specifically concern
herself and Ms. Chute. Tr. 2075-2076.

f. She left DHS because she "chose to retire" and
denied that she was asked to leave DHS. Tr. 2074-
2075.

g. She filed for retirement in mid-December 1993
and, in the retirement papers, had given her
intention to retire in January 1994. Tr. 2079-2081.

71. %I find Ms. Downing's testimony regarding the
circumstances surrounding the DHS-San Diego investigation
and the reasons why she left DHS less than forthright
and, at times, not consistent with the actual events
surrounding her departure from DHS.

72. Ms. Downing's attempt to hide the true nature of the
DHS investigation that began in October 1993 greatly
undermines my confidence in her credibility.

73. %I find Ms. Allison's testimony to be credible and
accept it as being a truthful and accurate account of the
events in question.

74. Based on Ms. Allison's testimony and the contents of
the stipulation and settlement, I find not credible Ms.
Downing's assertions that she had already planned to
retire and that she had filed for retirement in mid-
December 1993, since Ms. Downing did not produce any
documents to support her assertion.

75. Whether Ms. Downing intended to retire or not, the
circumstances of the investigation and proposed adverse
action overtook any such plans and were the actual
reasons for her departure from DHS in January 1994.
12

76. Ms. Downing's testimony regarding the internal
investigation and the circumstances of her resignation
was less than truthful. Her questionable credibility
requires me to take a cautious approach in ascribing
weight to her other testimony on the substantive matters
of this case.

@ Non-Aj icability of c.F.R. Part 48 Subpart C --
Survey Forms and Procedures (pp. 40-63)

77. The nursing home reform provisions of the Omnibus
Budget Reconciliation Act of 1987 (OBRA '87) set minimum
statutory standards that skilled nursing facilities
(SNFs) must meet to participate in Medicare and nursing
facilities (NFs) must meet to participate in Medicaid,
provided nursing home residents with certain rights, and
established a structure for State and federal surveys and
certifications of nursing homes. 42 U.S.C. §§ 1395i-3
and 1396r. These requirements were in effect as of
October 1, 1990. Sections 4202(a) and 4214(a) of OBRA
"87.

78. OBRA '87 specifies the content, procedures, and
frequency of surveys as well as survey team composition.
42 U.S.C. § 1395i-3(g) (2) and 42 U.S.C. § 1396r(g) (2).

79. Under OBRA '87, each state is responsible for
certifying that SNFs are in compliance with the

requirements of the Act through the use of surveys
conducted pursuant to certain specified protocols.

80. Congress specified in OBRA '87 that by no later than
January 1, 1990, the Secretary develop, test, and
validate survey protocols for the standard and extended
surveys required by law.

81. Congress stated further that the failure of the
Secretary to carry out these mandates by January 1, 1990
shall not relieve any state or the Secretary of the
responsibility to conduct surveys required by OBRA '87.
42 U.S.C. §§ 1395i-3 and 1396r.

82. OBRA '87 fundamentally changed the survey and
certification process by establishing a patient-oriented
system to assess the quality of care actually furnished.
See 42 U.S.C. § 1395i-3(f) and (g); 42 U.S.C. § 1396r(f)
and (g).

83. The legislative history regarding OBRA '87 confirms
the intent of Congress to implement major reforms in
nursing home care and to create a resident-centered,
outcome-oriented survey process. See H.R. Rep. No. 391,
13

100th Cong., 1st Sess., pts. 1 & 2 (1987), reprinted in
1987 U.S. Code Cong. & Admin. News 2313-1; and H.R. Conf.
Rep. No. 495, 100th Cong., 1st Sess. (1987), reprinted in
1987 U.S. Code Cong. & Admin. News 2313-1245.

84. In July, October, and November 1987, HCFA published
proposed rules which dealt with the survey and
certification process, conditions of participation, and
enforcement regulations. 52 Fed. Reg. 24,752 (1987); 52
Fed. Reg. 38,582 (1987); 52 Fed. Reg. 44,300 (1987).

85. On June 17, 1988, HCFA, acting in accordance with a
February 18, 1988 court order in Estate of Smith v.
Bowen, 656 F. Supp. 1093 (D. Colo. 1987), promulgated
final regulations amending the Medicare and Medicaid
survey regulations then in effect. These final
regulations were based on the proposed regulations
published in July 1987. 53 Fed. Reg. 22,850 (1988).

86. Among the new regulations promulgated were 42 C.F.R.
Part 488, Subpart C. In the preamble, HCFA acknowledged
Congress! enactment of OBRA '87 and stated, among other
things, that "Cal new survey process is required by OBRA
‘87, effective in 1990." 53 Fed. Reg. at 22,853.

87. The survey procedures and guidelines in 42 C.F.R.
Part 488, Subpart C were revised by HCFA to comply with
congressional directives in OBRA '87 to develop new
protocols. These protocols were published in April 1992
as SOM 250.

88. In August 1992, HCFA published proposed regulations
which would further implement provisions of OBRA '87, as
further amended by 1988, 1989, and 1990 legislation. 57
Fed. Reg. 39,278 (1992) .

89. The Federal Register preamble to the final
publication of 42 C.F.R. Part 488, Subpart C, notified
interested parties that (1) this Subpart pertained to
conditions of participation for long-term care facilities
that were in effect at the time of publication and (2)
HCFA was, at the time of publication, in the process of
making significant and wide- ~ranging changes to the
existing conditions of participation based on various
amendments to the law, principally OBRA '87. 53 Fed.
Reg. 22,850-22,853 (1988).

90. At least as of August 1992, HCFA put SNFs on notice
that the interpretive guidelines and survey procedures
used in federal and state surveys were revised in April
1992. 57 Fed. Reg. at 39,283 (1992).
14

91. At the time of its December 1993 survey, Petitioner
was bound by the survey protocols and by the applicable
regulations pertaining to the conditions of participation
found at 42 C.F.R. § 483, Subpart B.

92. The survey procedures set out in 42 C.F.R. Part 488,
Subpart C do not reflect the new and expanded
requirements created by OBRA '87, including those in the
areas of residents' rights, quality of patient life,
quality of care, and dietary, dental, pharmacy, nursing,
and physician services. See 42 U.S.C. §§ 1395i-3(b)-(da);
1396r-3(b)-(d); 42 C.F.R. § 483.10-483.75; 54 Fed. Reg.
5354-5355 (1989).

93. Subpart c is inconsistent with and does not
implement the OBRA '87 revisions to the health and safety
requirements that a long-term care facility must meet to
participate in the Medicare and Medicaid programs.

94. Subpart C pertains to survey methodology and
conditions of participation which became obsolete with
the implementation of the new conditions of participation
and survey processes mandated by OBRA '87, which did not
go into effect until October 1990.

95. HCFA's failure to withdraw Subpart C and to formally
publish the revised protocols in formal regulations does
not elevate outdated, obviously obsolete, survey
procedures and guidelines to a legal status which is
inconsistent with congressional intent.

96. The contents of 42 C.F.R. Part 488, Subpart C were
never modified and HCFA never formally repealed or
withdrew Subpart c.

97. Where an administrative regulation conflicts with a
statute, the statute controls. U.S. v. Doe, 702 F.2d
819, 823 (9th Cir. 1983).

98. A federal court ordered HCFA not to repeal Subpart
Cc. Estate of Smith v. Sullivan, (D. Colo. 1990). (HCFA
Attachment 2 at 1, 3).

99. A federal court permitted HCFA, on an interim basis,
to use the new survey protocols. Id.

100. Any alleged non-conformity with the requirements of
the Administrative Procedure Act (APA) on HCFA's part is
moot in light of the district court's interim order.
15

101. HCFA has followed its regulations, procedures, and

precedents. Because Subpart C became null and void and,

thus, without any operative effect, HCFA's departure from
this subsection was justified.

102. HCFA did not violate any administrative norm by its
non-adherence to the survey procedures and guidelines
contained in Subpart c.

103. HCFA was not legally required to formally withdraw
or repeal Subpart C in order for this subsection to be
rendered inoperative by the passage of OBRA '87, the
provisions of which became effective on October 1, 1990.

e SOM 250 and its operational significance (pp. 64-67)

104. The provisions of SOM 250 are not "substantive,"
but "interpretive". Alcarez v. Block, 746 F.2d 593, 613
(9th Cir. 1984); American Hospital Association v. Bowen,
834 F.2d 1037, 1045 (D.C. Cir. 1987); Guadamuz v. Bowen,
859 F.2d 762, 771 (9th Cir. 1988).

105. HCFA published SOM 250 to provide guidance to state
surveyors, who are responsible for determining compliance
by long-term care facilities with federal requirements
imposed by statute and regulations.

106. SOM 250 was not intended to impose any requirements
that are not otherwise set forth in the statute or
regulations (HCFA Ex. 13 at 2-137); therefore, HCFA was
not required to formally publish these instructive
guidelines to state surveyors in the form of a
regulation.

107. SOM 250 must be read in connection with the
statutory and regulatory provisions regarding SNFs to
determine the operative protocols, definitions, and
standards that were applicable at the time of the survey
in issue.

e 42 C.F.R. 489.13 ~ 67-7.

108. The parties do not disagree that 42 C.F.R. § 489.13
requires Petitioner to be in compliance with Level A
requirements on the date of the survey.

109. The final regulations published by HCFA on February
2, 1989 (effective August 1, 1989, except where specified
otherwise) made clear that all regulatory requirements
were to be enforced to the fullest extent possible, not
just the more serious Level A type of deficiencies. 54
Fed. Reg. 5317-5318 (1989).
16

110. In the Federal Register preamble to the publication
of the September 1991 regulations, HCFA reiterated that
long term care facilities, including SNFs, were subject
to enforcement for all violations of requirements and
that it was never intended that the Level A and Level B
designations imply a hierarchy of importance. 56 Fed.
Reg. 48,827.

111. There no longer exists any distinction between
Level A and Level B requirements because every violation
is considered to be potentially sufficient to deny
certification.

112. The phrase "all other requirements" contained at 42
C.F.R. § 489.13 means that SNFs not only must meet all
requirements established by regulation, but that any
violation of the regulatory requirements can provide a
basis to deny certification. Transitional Hospitals
Corporation -- Las-Vegas, DAB CR350 (1995); SRA, Inc.

D/B/A St. Mary's Parish Dialysis Center, DAB CR341
(1992).

e 42 C.F.R. § 488.110(j) (pp. 74-76)

113. Petitioner did not prove that it met all federal
requirements by the completion date of the survey;
therefore, its certification can only be the earlier of
the date on which it met all requirements or the date
when it submitted an acceptable plan of correction or
approvable waiver request to HCFA. 42 C.F.R. § 489.13.

114. Petitioner did not prove, or even allege, that it
had made a waiver request or that one was granted.

115. The only issues that are relevant to the
determination of the effective date in this proceeding
relate either to the date the deficiencies were corrected
or the date HCFA accepted Petitioner's plan of
correction.

116. Section 488.110(j) provides that the state agency
is to forward HCFA 2567 to facilities within 10 days
after a survey is completed. Ten calendar days from
December 23, 1993 is January 2, 1994.

117. Neither 42 C.F.R. § 488.110(j), nor any other
provision in this section, contains any penalty provision
for the agency's failure to comply with this 10-day
requirement.
17

118. There is no provision in 42 C.F.R. § 489.13 to
respond to situations where HCFA delays transmittal of
the form 2567 to a SNF.

119. An administrative law judge does not have the
authority to equitably split the difference or fashion a
remedy based on HCFA's noncompliance with the 10-day
requirement.

120. As an administrative law judge, I do not have the
authority to find the regulations ultra vires the Act,
which is what I would have to do in order to grant
Petitioner the relief it seeks.

121. I interpret the alleged 10-day "requirement" as a
goal which HCFA should strive to meet in all cases, but
not as something which should either invalidate the
survey nor mandate that HCFA grant the SNF with an
earlier certification date than it was given, in cases
where this goal is not met.

© Case-mix stratified sample (pp. 76-79)

122. SOM 250 contains detailed instructions and guidance
to enable surveyors to carry out "case-mix stratified
sampling." HCFA Ex. 13 at P-9 - P-12.

123. The regulation set out at 42 C.F.R. § 488.110(d)
("Task 2 -- Resident Sample -- Selection Methodology")
refers to a random sample.

124. Subpart C of 42 C.F.R. Part 488, which describes
random sampling, does not conform to the case-mix
stratified sampling requirement of OBRA '87 (and codified
at 42 U.S.C. §§ 1395i-3(g) (2) (A) (ii) and
1396r(g) (2) (A) (ii)).

125. The correct and appropriate sampling methodology to
be used, since the enactment of OBRA '87, is the case-mix
sampling approach, which is elaborated upon in the SOM
250.

126. The survey team members referred to the SOM 250 in
selecting resident samples. Tr. 2136.

127. The surveyors' use of a case-mix stratified sample
was in accordance with the law. Tr. 1648-1650, 1670,
2450, 2456.
e cies set out i he _ HC: 567 CFA Ex. 2 .

79-183)

128. The provisions of SOM 250 are the applicable
criteria to follow in determining whether a deficiency
has been established.

129. SOM 250 directs the surveyor to analyze the
frequency and severity of noncompliance with regulatory
requirements and to determine whether the facility is in
compliance with an individual requirement by assessing
the frequency or severity of the alleged violation.

130. Specifically, SOM 250 directs the surveyor to take
into account negative resident outcomes.

131. A deficiency can occur when there is evidence of
noncompliance with a regulatory requirement in 42 C.F.R.
§ 483, and the noncompliance has a serious negative
impact on the resident or residents, such as harm or a
strong potential for harm.

e F221 (Resident's right to be free from restraints) (pp.
84-90)

132. Ensuring that residents are restrained only to the
extent absolutely necessary for their medical well-being
or safety was of paramount concern to the authors of the
law and the regulations. H.R. Rep. No. 391, 100th Cong.,
ist Sess., part 1, at 932 (1987); 42 C.F.R. § 483.13(a).

133. The SOM 250 guidelines direct that an SNF document
that the facility has considered less restrictive
alternatives to restraints. HCFA Ex. 13 at P-76 - P-77.

134. The record contains nothing which would indicate
that the interdisciplinary team ever considered less
restrictive alternatives for resident 16.

135. The statutory and regulatory framework, the
language of the regulation, and the guidance contained in
SOM 250 all support that it is incumbent upon Petitioner
to document that the restraint was necessary for the
resident's medical or safety needs.

136. Petitioner did not prove that it ever considered
less restrictive alternatives for resident 16 because the
evidence HCFA has offered is persuasive, credible and
unrebutted.
19

137. HCFA has proven that Petitioner was in violation of
the regulatory requirement set forth at 42 C.F.R. §
483.13(a) with respect to resident 16.

138. Without adequate documentation that other less
restrictive alternatives were not available, placement of
resident 16 in a vest restraint could result ina
potential negative outcome. P. Exs. 1, 27; HCFA Ex. 13
at P-76 - P-77.

e F 262 (Facility must maintain a sanitary, orderly and
comfortable interior) (pp. 90-93)

139. An inadvertent typographical error occurred in the
HCFA 2567 when Ms. Shekell apparently mistyped "F 262" on
her lap-top computer instead of "F 261." The computer is
programmed by HCFA to automatically display the
applicable regulatory citation that corresponds to the
"F" number entered. Tr. 112-113, 115-116, 121.

140. The regulatory citation corresponding to F 261 is
42 C.F.R. § 483.15(h)(2). Tr. 121; HCFA Ex. 13 at P-96 -
P-97.

141. Subsection (h) (2) of 42 C.F.R. § 483.15 is the most
appropriate subsection for this deficiency since the
findings set forth in the HCFA 2567 pertain to the
facility's sanitary condition. HCFA Ex. 2 at 2-3.

142. Petitioner received adequate notice of the
deficiency even considering the incorrect reference to
the regulations.

143. Petitioner offered no witness who was present
during the survey who specifically contradicted the
observations of Ms. Shekell.

144. Petitioner's non-compliance with the regulatory
requirements could potentially compromise the residents!
health and safety or at least compromise their mental or
psychosocial well-being.

e F 272 (Facility must make a comprehensive assessment of
a_resident's needs. . .) (pp. 93-107)

145. The record of resident 12 is the only resident
record against which Petitioner could adequately prepare
a defense with respect to F 272. P. Ex. 3.

146. With respect to the other residents referred to in
the HCFA 2567, HCFA was unable to specifically identify
them or the records alleged to be deficient.
20

147. HCFA did not prove that Petitioner's treatment of
other residents, in addition to resident 12, violated 42
C.F.R. § 483.20(b) (1).

148. A new minimum data set (MDS) must be completed
promptly after a resident experiences a significant
change in physical or mental condition. In no case can
the MDS be done less than once every twelve months. 42
C.F.R. § 483.20(b) (4) (iv)-(v); see Tr. 138.

149. Depending on a particular response on the MDS, an
“automatic trigger" or "potential trigger" may be
indicated, and such triggers direct the staff to fill out
the corresponding category on another document called the
Resident Assessment Protocol Summary (RAPS).

150. Resident 12's MDS was completed on July 30, 1993.
P. Ex. 3 at 2. The relevant section of the MDS for

purposes of this deficiency is Section H, which has the
heading "Mood and Behavior Patterns". P. Ex. 3 at 3-4.

151. Resident 12 showed an indication of a potentially
serious psychological problem. P. Ex. 3 at 15 (9/15/93
psychological report).

152. Petitioner did not conduct a new MDS in September
1993 and left the July 1993 MDS in place, unchanged. In
doing so, Petitioner thus inaccurately represented that
the July 1993 MDS continued to reflect the current
condition of resident 12 although it did not.

153. Petitioner should have completed a new MDS after
resident 12's psychological interview to reflect the
change in her psychosocial status.

154. The resident was provided weekly individual and/or
group psychotherapy by a psychologist starting September
15, 1993 through December 22, 1993. P. Ex. 3 at 16 - 19.

155. Resident 12's desire to isolate herself was care-
planned (addressed in the plan of care) on September 1,
1993. P. Ex. 3 at 24.

156. Resident 12's suicidal ideation, as illustrated by
her expressing a desire to die on September 15, 1993, was
not care-planned until November 17, 1993. Id.

157. Petitioner delayed over two months before
implementing a care plan to address resident 12's
suicidal ideation.
21

158. Resident 12 manifested serious problems in terms of
her psychosocial well-being, and her July 30, 1993 MDS
was inaccurate with respect to her psychosocial status as
of at least September 15, 1993, or earlier, possibly
September 1, 1993, which is the first indication in the
record that she wanted to isolate herself.

159. There is no evidence that Petitioner ever completed
a new MDS for resident 12.

160. Petitioner violated the requirement found at 42
C.F.R. § 483.20(b) (1), with respect to resident 12.

161. Petitioner's failure to maintain an accurate
assessment of resident 12's condition as the level of her
depression worsened prevented the formulation of a timely
comprehensive care plan prepared using the protocols
specified by HCFA and which corresponded to her change in
psychosocial well-being.

162. By failing to accurately document resident 12's
depression in the assessment instrument, Petitioner
ignored the directives of OBRA '87 and contravened its
obligation to provide appropriate "individualized care"
of high quality to its residents.

e F 289 (Review of assessments) (pp. 107-122)

163. At the time of resident 16's admission, on May 1,
1993, a bowel and bladder assessment was done, which
reflected that resident 16 was "inc[ontinent] of b[owel]
and b[{ladder] and "not a candidate for bladder and bowel
retraining [secondary to] unawareness of bodily
function." P. Ex. 4 at 11.

164. On resident 16's MDS, which was completed on May
14, 1993, Petitioner's staff assessed her as being
incontinent of bowel and bladder. P. Ex. 4 at 3.

165. In the November 5, 1993 quarterly assessment,
Petitioner failed to reflect accurately resident 16's
bladder continence status, in violation of 42 C.F.R. §
483.20(b) (5).

166. From November 30, 1993 through December 2, 1993,
resident 16 underwent a "3-day evaluation for baseline
data -- bladder training". P. Ex. 4 at 12.

167. The result of the 3-day evaluation was that
resident 16 was assessed to be continent. P. Ex. 4 at 34
(duplicated at P. Ex. 4 at 13).
22

168. Petitioner failed to complete a new MDS and simply
left in place the MDS completed on May 14, 1993, which
assessed resident 16 as being incontinent of bladder (and
bowel).

169. By not updating the MDS, Petitioner plainly
violated 42 C.F.R. § 483.20(b) (5), which required
Petitioner, as appropriate, to revise resident 16's
assessment to assure its continued accuracy.

170. Resident 16 was not incontinent during December
1993.

171. By ignoring its obligation to comply with 42 C.F.R.
§ 483.20(b) (5), Petitioner was essentially representing
that between May 1993 and the time of the survey
(December 1993), resident 16 had not undergone any
changes at all with respect to her continence status and
remained totally incontinent.

172. Failure to have an accurate assessment of resident
16's continence prevented this resident from attaining
her highest practicable level of physical, mental, and
psychosocial well-being and potentially could have
compromised her health and safety, since she could have
been exposed to infection if continence had not been
maintained.

173. HCFA's allegation in the HCFA 2567 that resident
16's care plan was not updated to reflect her actual
status is extraneous to 42 C.F.R. § 483.20(b) (5), and I
did not consider it.

174. The part of the deficiency, as set forth in the
HCFA 2567, which alleges that there was no routine
individualized toileting schedule developed to meet
resident 16's needs (HCFA Ex. 2 at 5) is extraneous to 42
C.F.R. § 483.20(b) (5), and I did not consider it.

175. HCFA did not prove that resident 12's October 27,
1993 quarterly review is inaccurate.

176. Resident 12's July 30, 1993 MDS is inaccurate and
there is no evidence in the record that Petitioner ever
completed a new MDS for resident 12. FFCL 152, 159.

177. Petitioner violated 42 C.F.R. § 483.20(b)(5) with
respect to resident 12.

178. The August 23, 1993 quarterly review, which
indicated that resident G.B. had no mood problems in the
last seven days, is accurate. P. Ex. 9.
23

179. Petitioner inaccurately assessed resident G.B.'s
mood problems in the quarterly reviews dated May 28, 1993
and December 1, 1993.

180. Petitioner failed to complete a new MDS for
resident G.B. in December 1993, when G.B. began to refuse
treatment, a significant change in behavior.

181. Petitioner violated 42 C.F.R. § 483.20(b) (5) with
respect to resident G.B.

. si ' mprehensiv. e an -_123-
125)

182. Resident 16's care plans, dated May 1, 1993 and
November 7, 1993, were inaccurate because they failed to
mention resident 16's improvement in bladder condition
from incontinency to continence.

183. Petitioner violated 42 C.F.R. § 483.20(b)(6) by
failing to revise resident 16's care plan once she was
assessed by Petitioner's staff to be continent.

184. Petitioner's failure to revise resident 16's care
plan had the potential to cause a negative outcome for
this resident.

e F 29 Each assessment must be conducted or coordinated

with the appropriate participation of health
professionals) (pp. 125-128)

185. The rehabilitation screen is part of the assessment
process, but is not part of the assessment instrument.

186. After completing resident 13's rehabilitation
screen, the physical therapist should have participated
also in formulating the body control problems section of
resident 13's MDS.

187. Although a licensed vocational nurse (LVN)
completed the body control problems section on resident
13's MDS, she was not the appropriate health professional
to complete this section.

188. Petitioner's failure to involve a physical
therapist in the completion of the MDS did not negatively
impact resident 13.

189. The omission of contractures on the MDS did not
adversely impact the completion of the other sections.
P. Ex. 20 at 4.
24

190. There is no evidence that resident 13 suffered any
harm or that a potential for harm existed.

191. Petitioner did not violate 42 C.F.R. §
483.20(c) (1).

e F 295 (Comprehensive care plans) (pp. 128-141)

192. Petitioner failed in February 1993 to
contemporaneously care-plan the physician's February 11,
1993 order that resident 1 could have her own medications
at bedside, in violation of 42 C.F.R. § 483.20(d) (1).

193. The record contains only a December 2, 1993 care
plan relating to self-medication. P. Ex. 21 at 30.

194. Resident 1's medical chart contains two assessment
forms titled "Self-Administration of Medication
Assessment," dated April 1, 1993 and December 2, 1993.
P. Ex. 21 at 26-27.

195. According to the April 1, 1993 assessment, which
was signed by a licensed nurse and a physician, resident
1 was evaluated as not being mentally or physically able
to self-administer medication. P. Ex. 21 at 27.

196. According to the December 2, 1993 assessment, which
was signed also by a licensed nurse and a physician,
resident 1 was found to be a candidate for safe self-
administration of medications. P. Ex. 21 at 26.

197. Whether it was the February 11, 1993 physician
order or the December 2, 1993 assessment that triggered
the 12/2/93 care plan, once Petitioner was aware of the
February 11, 1993 order, it should have initiated a care
plan consistent with such order. This was not done.

198. There were instances in December 1993 when resident
1 refused to allow Petitioner's staff to monitor her
self-administration of her medications. P. Ex. 21 at 31-
34.

199. Such refusals on the part of resident 1 were not
minor or inconsequential.

200. Resident 1's actions of non-compliance directly
conflicted with the December 2, 1993 care plan
approaches.

201. Once it was ascertained that the December 2, 1993
care plan approaches could not be carried out
successfully due to resident 1's refusals and her own
25

physical condition, Petitioner should have developed a
new care plan which addressed fully resident 1's current
needs.

202. There is no evidence of a care plan that mentions
the problems of resident 1's refusals and her physical
inability to self-administer medicines or addresses how
to adequately monitor her taking of medications in light
of these problems and difficulties.

203. Petitioner's failure to develop a new care plan on
these grounds establishes further that it violated 42
C.F.R. § 483.20(d) (1). FFCL 202.

204. The Social Services notes (see P. Ex. 21 at 17-19)
state that the resident exhibited yelling and screaming
on October 4, 1993, October 8, 1993, and November 15,
1993, and manifested confusion on October 8, 1993 (P. Ex.
21 at 18).

205. Resident 1's November 30, 1993 quarterly review was
inaccurate in its assessment that resident 1 had no mood
or behavior problems. P. Ex. 21 at 7-8, 17-19.

206. Resident 1's mood and behavior problems should have
been reflected in the December 2, 1993 care plan, and
Petitioner's failure to do so constitutes a further
violation of 42 C.F.R. § 483.20(d) (1).

207. By leaving a misleading and inaccurate care plan in
place, thereby representing it to be accurate and up-to-
date, Petitioner potentially could have jeopardized
resident 1's health, safety, and well-being.

° F297 (A resident's care pL an must be prepared by an

terdis inary tea:

208. There is nothing in the findings with respect to
F 297 that identifies Petitioner's conduct in
contravention of the requirements of 42 C.F.R. §
483.20(d) (2) (ii), which are limited to a resident's care
plan.

209. The evidence offered by HCFA in the HCFA 2567
relating to Resident 1's assessments is extraneous and
goes beyond the regulation at issue.

210. The deficiency, as set forth in the HCFA 2567,
fails to state with sufficient particularity the care
plan in issue, the make-up of the interdisciplinary team
who prepared such care plan, and how that grouping was in
violation of the cited regulation.
26

211. Petitioner did not violate 42 C.F.R. §
483.20(d) (2) (ii).

e F 298 (comprehensive care plan must be periodically
reviewed and revised after each assessment) (pp. 143-150)

212. At the time of the surveyor's observation, resident
20 was using a postural seating system which had been
instituted pursuant to a physician's order dated
September 28, 1993, which is noted in the care plan also.
P. Ex. 23 at 4, 12.

213. Although the care plan does not specify the type of
seating system used on resident 20, the seating system
which was in place for resident 20 at the time of Ms.
Cox's observation was a Linard seating system. Tr. 1308.

214. The scenario involving resident 20 occurred as Ms.
Cox described it.

215. Petitioner presented no testimony from anyone on
its staff who was present at the time of Ms. Cox's
observation of resident 20 to contradict her testimony.

216. Petitioner's staff changed resident 20's seating
system. The staff placed resident 20 in a "saddle type
of thing" and replaced his chair to alleviate his
discomfort and help him sit upright. Tr. 1062, 1308,
1310.

217. The changes made by Petitioner's staff were
significant and constituted more than a simple re-
adjustment of resident 20's existing seating system. As
such, Petitioner's staff was required to update resident
20's care plan contemporaneously to reflect this change.
FFCL 216.

218. By its failure to revise resident 20's care plan,
Petitioner did not comply with 42 C.F.R. §
483.20(d) (2) (iii).

219. The existence of the 4/12/94 entry in resident 1's
care plan indicating the addition of a "western saddle"

(P. Ex. 23 at 12) does not disprove Ms. Cox's testimony

that a saddle was provided to resident 20 at the time of
the survey in December 1993.

220. Petitioner's representation in its plan of
correction that resident 20's care plan had been updated
to reflect the change is uncorroborated by the record
before me.
27

221. While there is no evidence of actual harm
to resident 20's health or safety, I find that there
existed the potential of harm to resident 20.

e F300 (Services provided by the facility must be
provided by qualified persons in accordance with each

resident's care plan) (pp. 150-158)

222. Petitioner does not dispute the facts relating to
resident 24's E-Z boot as cited in the deficiency, which
were based on Ms. Cox's observations. P. Resp. Br. at
24.

223. HCFA did not offer in evidence a plan of care which
implements the physician's order requiring use of the E-Z
boot.

224. While Ms. Cox could not recall at the hearing what
the plan of care said about application of the E-Z boot,
she did testify that she reviewed the care plan in
connection with preparation of this deficiency. Tr.
1069-1070.

225. Besides Ms. Cox's testimony, my review of this
resident's records, including the minimum data set,
quarterly review, rehabilitation screen and physician's
order, leads me to conclude that a care plan was
developed for this resident which carried out the
physician's order for application of the E-2 boot. P.
Ex. 24.

226. Even without having the care plan in evidence,
there is sufficient evidence to create a strong inference
that such plan existed and was relied on by Ms. Cox in
preparing this deficiency.

227. Petitioner had the burden to come forward with
evidence proving that the care plan did not cover the E-Z
boot. This Petitioner failed to do.

228. Based on the record as a whole, I find that
Petitioner failed to carry out the physician's order in
accordance with the resident's care plan.

229. Petitioner failed to prove that the deficiency was
corrected prior to completion of the survey.

230. From December 10 through December 21, 1993, the E-Z
boot was either missing or unavailable. P. Ex. 24 at 12.
Petitioner's staff did nothing to locate the missing boot
or take steps to get a new boot. Tr. 1069-1070; P. Ex.
24 at 11, 12.
28

231. Petitioner's failure to have a monitoring system in
place contributed to its failure to locate the E-Z boot
until the surveyor directed the attention of the staff to
its absence.

232. Petitioner did not prove, or even allege, that a
monitoring system was in place or put in place at the
time of the completion of the survey.

233. This deficiency was not corrected at the completion
of the survey.

234. The lack of a monitoring system placed resident 24
and other residents at risk that their treatment would
not be provided as ordered by their physicians and
implemented in their care plans.

235. Resident 8's care plan specifically provided that
his fluid intake would be at least 1700 cc's of fluid
over a 24-hour period. P. Ex. 25 at 5.

236. The care plan mandates that 1700 cc's was the
minimum amount of fluid that this resident was to be
provided within a 24-hour period.

237. During the period December 2 - 19, 1993, resident 8
met the objective only on December 2 and 17, 1993. P.
Ex. 25 at 2-4.

238. Petitioner failed to have this resident meet the
1700 cc daily objective called for in the care plan. P.
Ex. 25 at 2-4.

239. Petitioner's staff monitored the resident's fluid
intake and output. P. Br. at 92.

240. Monitoring resident 8's fluid intake and output and
encouraging increased intake was not a substitute for
following the specific intake objective contained in the
plan of care.

241. Petitioner failed to treat resident 8 in accordance
with his written plan of care and thereby violated 42
C.F.R. § 483.20(d) (3) (ii).

242. Reduction of this resident's fluid intake below the
care plan objective might have placed him at risk for
pneumonia and skin breakdown. Tr. 1078; 2588-2589.
29
e F 309 (Necessary care and services to attain or

in the es’ acticable i ta and
psychosocial well-being, in accordance with the
comprehensive assessment and e a + 158-164

243. Resident 20's weight upon his admission to the
facility on March 30, 1993 was 108.4 pounds. P. Ex. 26
at 10.

244. Resident 20 had, among other conditions,
Parkinson's disease and difficulty in swallowing
(dysphagia). P. Ex. 26 at 1, 10.

245. Resident 20 continued to lose weight during his
stay at Petitioner. P. Ex. 26.

246. The record as a whole reflects that resident 20 was
attempting to eat his meals independently but was unable
to do so and was unable to consume sufficient nourishment
with the assistance that was being provided by
Petitioner. P. Ex. 26; Tr. 233-236.

247. The only methods attempted by Petitioner to assist
resident 20 were providing him with a special spoon and
offering him additional nourishment.

248. The record reflects that both of these methods were
ineffective, as resident 20 was observed as not being
able to eat independently and was not amenable to
accepting the additional nourishment offered by
Petitioner.

249. Petitioner could have tried other methods, short of
tube feeding or force feeding, to attempt to enable
resident 20 to eat more, but Petitioner failed to do so.

250. There is no evidence in the record that resident 20
was ever reassessed or that his care plan was adjusted in
light of the difficulties he was having in consuming
sufficient nourishment. P. Ex. 26.

251. Petitioner failed to provide resident 20 with the
care necessary to maintain or attain his highest
practicable well-being, in violation of 42 C.F.R. §
483.25.

252. Resident 16 began the RNA ambulation program on
June 15, 1993, and the initial program was for her to
ambulate with a front wheel walker 20 feet to 60 feet
with the assistance of two persons, as tolerated, seven
times a week. P. Ex. 27 at 13-14; Tr. 1091-1092.
30

253. Resident 16 was ambulating from 60 to 100 feet
during the period June 15 - June 30, 1993, and from 80 to
100 feet during the period July 1 - July 31, 1993. P.
Ex. 27 at 13, 15.

254. On August 9, 1993, resident 16 was discontinued
from the RNA program. P. Ex. 27 at 17-18.

255. Nurse assistant records in resident 16's chart
indicated that resident 16 was ambulated daily throughout
November and December 1993. Tr. 1517-1523, P. Ex. 1 at
14-17.

256. Resident 16 was ambulated routinely following the
conclusion of the RNA program. Id.

257. HCFA did not prove that resident 16's ambulation
declined.

258. The testimony of HCFA's witnesses on this issue is
conflicting and unpersuasive.

259. HCFA did not prove that resident 16 was not
maintained at her highest practicable level with respect
to her ambulation.

260. Petitioner was not deficient with regard to
maintaining the ambulation of resident 16 at its highest
practicable level.

e 320 ressure sores - 164-167

261. The purpose of using a Tegaderm dressing in
treating resident 31 was to act as a barrier to protect
her pressure sores from bacteria, to keep in place the
gel that was used to treat the sores, and to prevent
further skin breakdown caused by the open sores coming
into contact with the resident's bed or bedding. MTr.
2620-2621.

262. At the time of the survey, the surveyor observed
that the dressings were not in place. Tr. 241.

263. Resident 31 had more than one Tegaderm dressing
missing. Id. This put her at a greater risk for
bacterial infection. Tr. 2621.

264. Resident 31's treatment record indicated that the
dressings were in place and had been checked for proper
placement on the previous shift. Tr. 241.
31

265. Petitioner failed to follow the physician's order
concerning treatment of resident 31's pressure sores.

266. Petitioner violated 42 C.F.R. § 483.25(c) (2) with
respect to the treatment of resident 31.

¢ F 324 (Range of motion) (pp. 167-168)

267. HCFA has conceded that resident 2 is not the
correct subject of this deficiency. HCFA Br. at 72.

268. Examples of residents who were discussed in other
deficiencies would not corroborate the allegations in
this deficiency, because the HCFA 2567 mentioned no
cross-references with regard to this deficiency.

269. HCFA did not prove that Petitioner was in violation
of 42 C.F.R. § 483.25(e) (2).

e F 373 (facility must offer snacks at bedtime daily)
(pp. 168-174)

270. Petitioner's monthly flow sheets, particularly
those with dashes, "NA", "N", and "no", support a finding
that a number of residents were not offered bedtime
snacks and were not on special diets which would have
precluded the consumption of such food.

271. Ms. Downing's explanation of the meaning of a dash,
and arguably similar meanings for "N", and "no", is
lacking in credibility.

272. Bedtime snacks were neither offered nor provided.

273. While Petitioner provided special snacks to
residents who requested something different than the
routine snacks (Tr. 2039-2040; Id. at 73-93), this does
not demonstrate compliance with the regulation, which
requires Petitioner to offer bedtime snacks to all
residents unless it is medically contraindicated.

274. There is no credible evidence that Petitioner's
policy was revised before the survey was completed.

275. Petitioner implemented the "Procedure for Bed Time
(H.S.) Snack" policy reflected in P. Ex. 30 at 94-95
after the survey was completed and the plan of correction
was submitted.

276. Petitioner demonstrated a pattern of violating the
regulation requiring residents to be offered bedtime
snacks.
32

277. Petitioner's failure to provide snacks as required
by regulation would likely result in a diminishment of
the mental and psychosocial well-being of its residents.

278. Petitioner failed to provide bedtime snacks daily
to all of its residents, in violation of 42 C.F.R. §
483.35(f) (3).

@ F441 (Infection contro] program) (pp. 174-181)

279. The nurse's actions at issue were inconsistent with
standard protocol.

280. The gravity of this breach in acceptable protocol
was a substantial action supporting the deficiency.

281. The medication nurse's acts of placing a juice
container from the medication cart onto the over-bed
table of a resident on contact isolation with MRSA
{methicillin resistant staphylococcal aureaus}, and then
returning the container to the medication cart,
represented a failure by Petitioner to control and
prevent infections as required by 42 C.F.R. §

483.65(a) (1).

282. The statement that Petitioner failed to use sterile
and/or aseptic technique in the care of residents with
decubitus open areas, as written in the HCFA 2567, is
vague and confusing. The document did not make clear
whether this part of the alleged deficiency related to
the observation of the treatment of one resident or more
than one resident, and whether the deficiency related to
the failure to follow sterile technique, aseptic
technique, or both.

283. Ms. Shekell's testimony as a whole emerged confused
and contradictory.

284. HCFA failed to prove what specific policies and
procedures Petitioner was required to follow, and did or
did not follow, with respect to sterile and/or aseptic
treatment of resident wounds.

285. HCFA did not prove that Petitioner failed to use
sterile and/or aseptic technique when required.

286. HCFA did not prove that sterile and/or aseptic
technique was not followed by Petitioner when required to
control and prevent infection as required by 42 C.F.R. §
483.65(a) (1).
33
. 443 (Infection cont: rogram +18

287. The HCFA 2567 does not set forth a finding or basis
for F 443.

288. Ms. Shekell admitted that F 443 had been
inadvertently keyed into the computer. Tr. 257.

289. There is no deficiency here.

e F 462 (Resident rooms) (p. 182)

290. HCFA did not prove this deficiency.

e F 527 (Clinical records) (p. 182-183)
291. HCFA did not prove this deficiency.
e Findings summarized and concluded (p. 183)

292. Under 42 C.F.R. § 489.13, even one deficiency could
be the basis for a delay in the effective date of
certification.

293. Deficiencies showing a lack of compliance with 42
C.F.R. § 483 et. seq. were present during the survey of
Petitioner, were not corrected at completion of the
survey, and were the subject of an acceptable plan of
correction submitted on January 31, 1994.

294. Accordingly, I affirm HCFA's determination that
Petitioner's certification as a Medicare provider was
effective on January 31, 1994.

II. Background

Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395
et seq., commonly known as the Medicare Act, establishes
a federally subsidized health insurance program for the
elderly and disabled which is administered by the
Secretary of the Department of Health and Human Services
(the Secretary). The Secretary has delegated to HCFA the
responsibility for carrying out many of the duties under
this program.

Skilled nursing facilities or other entities may
participate in the Medicare program by entering into a
"provider agreement" with the Secretary. 42 U.S.C. §§
1395x(u) and 1395cc. A skilled nursing facility is
defined under section 1819(a) of the Social Security Act
(Act) as an institution which is primarily engaged in
providing skilled nursing care and related services for
34

residents who require medical or nursing care, or
rehabilitation services for the rehabilitation of
injured, disabled, or sick persons, and is not primarily
for the care and treatment of mental diseases.
Additionally, such an institution must meet also the
requirements of 42 U.S.C. 1395i-3(b), (c) and (d).

DHS-San Diego is authorized to perform surveys of skilled
nursing facilities to make recommendations to HCFA on
whether such facilities meet the Federal requirements for
participation in the Medicare program. 42 U.S.C. §
1395aa(a). Onsite inspections (surveys) of facilities
must be conducted without any prior notice to the
facility. See 42 U.S.C. § 1395i-3(g)(2)(A). The results
of Medicare related surveys are used by HCFA as the basis
for its decisions regarding a facility's initial or
continued participation in the Medicare program. The
findings of state agencies are recommendations to HCFA,
which makes the actual determination as to whether a
facility is eligible to participate or to remain in the
program. 42 C.F.R. § 489.10.

Petitioner is a skilled nursing facility, with
approximately 300 beds, operating in San Diego,
California. Tr. 1644.

On December 14-23, 1993, Petitioner was surveyed on
behalf of HCFA by surveyors from DHS-San Diego. The
purpose of the survey was to determine whether Petitioner
was conducting its operations in compliance with the
requirements of the Medicare program.

Following the survey, DHS-San Diego issued to Petitioner
a document captioned "Statement of Deficiencies and Plan
of Correction" (HCFA 2567), which sets out the
deficiencies identified during the survey. Although the
State surveyors found Petitioner to be in compliance with
all Level A requirements imposed by HCFA for skilled
nursing facilities, there were numerous Level B
deficiencies identified at the time of the survey. HCFA
Ex. 2. Petitioner was found to have failed to comply
with various regulations governing a skilled nursing
facility's participation in Medicare. These were: 42
C.F.R. §§ 483.13(a); 483.15(h) (3); 483.20(b) (1);
483.20(b) (5); 483.20(b) (6); 483.20(c) (1); 483.20(a) (1);
483.20(d) (2) (ii); 483.20(a) (2) (iii); 483.20(a) (3);
483.25; 483.25(c) (2); 483.25(e) (2); 483.35(f£) (3);
483.65(a) (1); 483.65(a) (3); 483.70(d) (1); and
483.75(1)(1). Id.
35

On January 31, 1994, Petitioner submitted its plan of
correction to the DHS. HCFA Ex. 2.5 By letter dated
February 23, 1994, HCFA notified Petitioner that it was
certifying Petitioner as a provider in the Medicare
program, effective January 31, 1994, the date of
Petitioner's acceptable plan of correction. HCFA Ex. 5.
On February 28, 1994, HCFA sent an amended notification
letter (changing only the designation of fiscal
intermediary). HCFA Ex. 6.

HCFA twice reconsidered its determination at Petitioner's
request. By letters dated March 25, 1994 and May 6,
1994, HCFA notified Petitioner that it found no basis to
alter its original determination. HCFA Exs. 8, 9.
Petitioner requested further review of the HCFA 2567
findings by DHS headquarters in Sacramento. DHS informed
Petitioner that the earliest possible certification date
was January 31, 1994. HCFA Ex. 10.

III. Evaluation of the credibility of Jacqy Downing

At the hearing, I heard testimony regarding the
circumstances surrounding an internal investigation of
DHS~-San Diego where Ms. Downing worked and the reasons
why Ms. Downing left her position at DHS-San Diego in
January 1994. This testimony is relevant to the extent
that it enables me to assess the credibility of Ms.
Downing, one of Petitioner's primary witnesses in this
case.

Ms. Downing denied any knowledge of problems regarding
the falsification of complaint documents in her office.
Tr. 2074. She stated merely that "[t]here were many
allegations going on in that department." Id. The
allegations "involved everybody in the office including
myself and the supervisor." Id.

Ms. Downing testified that a complaint is filed by a
third party (private citizen or an employee or
anonymously) to DHS-San Diego regarding a particular
facility. Tr. 2087-2088. The surveyors in the office
then investigate the complaints that are filed against
the facilities. Tr. 2089. The surveyors are supposed to
investigate every complaint. Id. One example of a

5 Petitioner was instructed to prepare a written
plan of correction to resolve the deficiencies and to
describe the proposed corrections in the right-hand
columns of the HCFA 2567. The HCFA 2567 which is in
evidence contains also Petitioner's plan of correction.
HCFA Ex. 2.
36

complaint that might be filed by the public would be that
the facility is not providing a relative or loved one
with the appropriate care. Id.

Ms. Downing admitted that an investigation "was going on"
in the office "at the time [she] retired." Tr. 2078.

She stated that she "didn't have any clear understanding
of what the investigation was." Tr. 2084. She denied
any knowledge that the focus of the investigation was
that complaint results were being reported which had not
been investigated. Tr. 2096. She claimed that she was
never informed of this by any of the investigators. Id.

Ms. Downing stated that she was not "personally
confronted" with charges concerning the investigation nor
were any allegations concerning any impropriety brought
to her attention during her interview with the
investigators. Tr. 2084, 2086-2087. She stated further
that no one told her that the complaints at issue
originated out of her survey team. Tr. 2084. She also
denied that the investigation specifically concerned
herself and Judith Chute. Tr. 2075-2076.

To counter the testimony of Ms. Downing, HCFA presented
the testimony of Joan Allison, who works for DHS in the
licensing and certification program as the chief of field
operations for the southern region. Tr. 2735-2736.

After reviewing the testimony of Ms. Downing and that of
Ms. Allison, as well as the other evidence, I conclude
that Ms. Downing's testimony regarding the circumstances
surrounding the DHS-San Diego investigation and the
reasons why she left DHS-San Diego was less than
forthright and, at times, not consistent with the actual
events surrounding her departure from DHS. I find Ms.
Allison's testimony, which I discuss below, to be
credible and accept it as being a truthful and accurate
account of the events in question. Ms. Downing's attempt
to hide the true nature of the DHS-San Diego
investigation that began in October 1993 greatly
undermines my confidence in her credibility.

Ms. Allison testified that she participated in an
internal investigation in October and November 1993
involving DHS-San Diego. Tr. 2738-2739, 2781. She
stated that

the focus of the investigation was to determine
whether or not complaint documents had been
altered in the San Diego district office.

Tr. 2738.
37

Ms. Allison explained why the investigation was
initiated:

A surveyor in the San Diego district office
pulled a facility file and discovered a 2567
that she had completed and found that the date
had been whited out, the signatures for the
evaluator and the supervisor had been whited
out, the complaint numbers had been whited out.
She was disturbed at that and looked further in
the folders and found that her 2567 has been
duplicated and then other information had been
written in to represent a 2567 on another
complaint investigation.

Tr. 2738; see also Tr. 2743.

Ms. Allison indicated that she and Paul Keller, who was
then chief of field operations for the southern region,
went to DHS~-San Diego and interviewed the district
manager, the district administrator, all of the
supervisors, including Ms. Downing, and one of her
surveyors who allegedly falsified the documents. Tr.
2740; Tr. 2755-2756.

Ms. Allison testified that approximately 80 survey
documents had been altered. Tr. 2743. She stated that
the falsified documents had Ms. Downing's name "signed as
the supervisor." Id. Ms. Downing's name was the only
name signed as supervisor on all of the falsified
documents. Id.

Ms. Allison stated:

The investigation determined that Ms. Downing
had given specific directions to the surveyor
in terms of how to prepare these complaint
documents including whiting out the information
and preparing the complaint documents in that
way. And then, subsequently, in approving and
sending forward all of these complaints as if
they had, in fact, been legitimately
investigated.

Tr. 2745.

It was determined that Ms. Downing had given her approval
and sent forward all of these complaints as falsified.
Tr. 2745. Ms. Allison stated that no other supervisors
were the focus of the investigation. Tr. 2743.
38

Ms. Allison testified also that the department's audits
and investigations division conducted a second
investigation. Tr. 2778, see Tr. 1758. The results of
this investigation confirmed the findings of her and Mr.
Keller's investigation. Tr. 2778-2779.

Thus, contrary to Ms. Downing's claims of lack of
knowledge regarding the details of the internal
investigation, there’ can be little doubt that Ms. Downing
was being investigated regarding the allegations and was
aware of it. Although Ms. Downing had claimed in her
testimony that she was never confronted with charges
involving herself, Ms. Allison testified that

Ms. Downing was notified that both -- that both
she and the -- a particular evaluator were
specifically being investigated relative to the
charges. Tr. 2782.

Ms. Allison testified that when Ms. Downing was asked if
she participated in the falsification of the documents,
Ms. Downing did "[n]jot categorically" deny it. Tr. 2755.
Ms. Allison stated that, by way of explanation, Ms.
Downing had said that her surveyor may have misunderstood
her directions, and also that she (Ms. Downing) may not
have paid close attention to work since her parents were
not well. Tr. 2755. Ms. Allison went on to say that Ms.
Downing had said "that when she advised her evaluator to
do some cut and paste, it had not been her intention that
they would reflect investigations that had not been
completed." Id.

Based on Ms. Allison's testimony, I find Ms. Downing's
earlier testimony that she "didn't have any clear
understanding of what the investigation was" (Tr. 2084)
is simply not factual and demonstrates her attempt to
recast the events as favorably as possible with respect
to her involvement in the investigation.

At the hearing, when asked by HCFA's counsel why she left
DHS, Ms. Downing responded that she "chose to retire."
Tr. 2074. She denied that she was asked to leave DHS.
Tr. 2075. Ms. Downing stated that she had made the
decision to retire on her birthday the year before. Tr.
2077. She testified that she was eligible for retirement
in the state system and claimed to have filed for
retirement in mid-December 1993. Tr. 2079-2081. In the
retirement papers, Ms. Downing stated that she had given
her intention to retire in January 1994. Tr. 2081.
39

Ms. Allison's testimony also called into question the
veracity of Ms. Downing's testimony regarding her
retirement from DHS. Ms. Downing testified that she was
not asked to leave DHS (Tr. 2075). However, according to
Ms. Allison, as a result of the investigation, in
December 1993, DHS served both Ms. Downing and the
evaluator with an action to dismiss from State service.
Tr. 2746, 2756, 2759-2760.°

Prior to a State hearing, DHS and Ms. Downing reached a
stipulated agreement, which required Ms. Downing to
resign effective January 14, 1994. Tr. 2746, 2758, 2779.
A hearing did not take place. Tr. 2758. Ms. Downing
resigned in accordance with the stipulated agreement.

Tr. 2779.

When asked by Petitioner's counsel whether Ms. Downing
had applied to retire before any adverse action was taken
against her by DHS, i.e., before December 30, 1993, Ms.
Allison responded that she was unaware that Ms. Downing
had submitted anything prior to being served with the
adverse action. Tr. 2757, 2766-2767. She stated that
she also had no knowledge as to whether Ms. Downing
expressed a desire to resign earlier than January 14,
1994. Tr. 2780. Ms. Allison expressed her belief that
DHS would not have issued the dismissal notice to Ms.
Downing if it had known that Ms. Downing was planning to
retire. Tr. 2780.

The record before me contains the stipulation and
settlement entered into between Ms. Downing and DHS in
February 1994. HCFA Ex. 14. Among its provisions, this
document states that DHS "agrees to withdraw its Notice
of Adverse Action against Appellant [Ms. Downing] dated
December 30, 1993." Another provision states that the
"Appellant agrees to resign from state service effective
January 14, 1994." HCFA Ex. 14. Based on Ms. Allison's
testimony and the contents of this document, Ms.
Downing's assertions that she had already planned to
retire and that she had filed for retirement in mid-
December 1993, seem suspect. Although she claimed to
have filed retirement papers, which state January 1994 as
her intended retirement date, no such documents were ever
produced. While it may have been Ms. Downing's choice to

6 Ms. Allison testified that the investigation
concluded in November 1993 or early December 1993, Tr.
2757, 2781. Ms. Allison stated also that DHS "took
constructive action to review the complaints to
determine" if they needed to be reopened or investigated.
Tr. 2746.
40

retire, the evidence strongly indicates that, had she not
resigned, DHS would have proceeded with its adverse
action against her. I need not determine whether Ms.
Downing had intended to retire. Whether she had that
intention or not, the circumstances of the investigation
and proposed adverse action overtook any such plans and
were the actual reasons for her departure from DHS in
January 1994.

Ms. Downing's testimony regarding the internal
investigation and the circumstances of her resignation
was less than truthful. Her questionable credibility
requires me to take a cautious approach in ascribing
weight to her other testimony on the substantive matters
of this case. She clearly was an advocate for the
positions put forth by Petitioner, her employer. She has
credible credentials in the field of nursing and
knowledge of the survey methodology followed by the DHS
while she was employed there. However, I found that
testimony, which, at times, supported positions taken by
HCFA in this proceeding, was given by Ms. Downing with
reluctance and hesitation. Moreover, at times, her
testimony supporting Petitioner's positions did not
comport with other, credible, evidence. Ms. Downing's
testimony will be discussed with greater particularity in
relation to the specific deficiencies to which her
testimony applies.

Petitioner has raised a number of legal issues regarding
the applicability and effect of the regulations
pertaining to the DHS survey in December 1993 and HCFA's
selection of January 31, 1994 as the effective date of
Petitioner's Medicare participation. I will address each
of these issues seriatin.

Iv. Issue:
Whether 42 C.F.R. Part 488, Subpart C -- Survey
‘orms a ocedures, was ollin

survey conducted in this case.

HCFA argues that the guidelines applicable to the survey
in this case are contained in State Operations Manual 250
(SOM 250) and that the survey materials set forth at 42
C.F.R. Part 488, Subpart C, "became obsolete and devoid
of legal force or effect when the OBRA '87 [Omnibus
Budget Reconciliation Act of 1987] provisions went into
effect on October 1, 1990." HCFA Resp. Br. at 58. HCFA
contends that the “survey forms, procedures and
guidelines contained in Subpart C not only are
inconsistent with and do not implement these new health
care requirements, they conflict" with the OBRA '87
41

requirements. Jd. HCFA alleges that the Subpart C
survey materials have been replaced by those contained in
SOM 250. HCFA claims that "Petitioner has never
maintained that it was unable to respond to the survey
findings due to the use of the SOM 250 protocols." HCFA
Resp. Br. at 68. Finally, HCFA asserts that a federal
district court order suspended Subpart C and gave HCFA
the authority to use SOM 250 "on indefinite interim
basis." HCFA Resp. Br. at 56 9.

In response, Petitioner disputes that OBRA '87 impliedly
repealed 42 C.F.R. Part 488 Subpart C. (P. Br. at 8) and
argues that HCFA's position "has no legal basis." P. Br.
at 13. Petitioner contends that "42 C.F.R. § 488.110
{is] still valid and binding on HCFA." P. Br. at 20.
Petitioner argues that the SOM 250 survey procedures
"effectively change those set forth in 42 C.F.R. §
488.110." Id. Petitioner claims that the SOM 250
procedures should have been promulgated in accordance
with the rulemaking requirements of the Administrative
Procedure Act because they are "substantive" in nature,
and the failure to have done so renders them invalid. P.
Br. at 17-20.

In discussing this issue, it is necessary to review the
historical background of OBRA '87 and the efforts
undertaken by HCFA to implement it.

A. OBRA '87

The nursing home reform provisions of OBRA '87 set
minimum statutory standards that skilled nursing
facilities (SNFs) must meet to participate in Medicare
and nursing facilities must meet to participate in
Medicaid, provided nursing home residents with certain
rights, and established a structure for state and federal
surveys and certifications of nursing homes. 42 U.S.C.
§§ 1395i-3 and 1396r. These requirements were in effect
as of October 1, 1990. Sections 4202(a) and 4214(a) of
OBRA '87.

OBRA '87 fundamentally changed the survey and
certification process by establishing a patient-oriented
system to assess the quality of care actually furnished.
See 42 U.S.C. § 1395i-3(f) and (g); 42 U.S.C. § 1396r(f)
and (g). These revisions established new standards
governing the provision of care in nursing facilities,
including requirements relating to the quality of patient
life, licensed nursing services, nurse aide training,
residents' rights, and many other aspects of nursing home
operation and administration. 42 U.S.C. § 1395i-3(b),
(c) and (d); 42 U.S.C. § 1396r(b), (c) and (dad). The
42

statute specifies the content, procedures and frequency
of surveys, as well as survey team composition. 42
U.S.C. § 1395i1-3(g) (2) and 42 U.S.C. § 1396r(g) (2).

Under OBRA '87, each state is responsible for certifying
that SNFs are in compliance with the requirements of the
Act through the use of surveys conducted pursuant to
certain specified protocols. Congress specified in OBRA
‘87 that the Secretary develop, test and validate by no
later than January 1, 1990 survey protocols for the
standard and extended surveys required by law. Also, by
such date, the Secretary was to develop minimum
qualifications for members of the team who are to conduct
such surveys. Congress further stated that the failure
of the Secretary to carry out these mandates by January
1, 1990 shall not relieve any state or the Secretary of
the responsibility to conduct surveys required by OBRA
"87. 42 U.S.C. §§ 1395i-3 and 1396r.

In the legislative history of OBRA '87’, the House
committee explained that the bill would repeal the
current Medicare participation requirements for SNFs, as
well as the current survey and certification
requirements, and replace them with new requirements.
H.R. Rep. No. 391, 100th Cong., 1st Sess., part 2, at
926, 938 (1987).

The report states that "{a] skilled nursing facility must
care for its residents in such a manner and in such an
environment as would promote maintenance or enhancement
of the quality of life of each resident." Id. at 927.
Further, the report indicates that, for this goal to be
attained, certain shortcomings in the current law must be
addressed. For example, the report notes, among other
things, that the current law does not require the use of
resident assessments nor does it require that a resident
assessment be linked or coordinated with a resident's
care plan. Id. at 926. To remedy the aforementioned
shortcomings, the committee set forth requirements in the

7 There are two House reports which comprise the
legislative history for H.R. 3545 (OBRA '87): H.R. Rep.
No. 391, 100th Cong., 1st Sess., pts. 1 & 2 (1987),
reprinted in 1987 U.S. Code Cong. & Admin. News 2313-1;
and H.R. Conf. Rep. No. 495, 100th Cong., 1st Sess.
(1987), reprinted in 1987 U.S. Code Cong. & Admin. News
2313-1245.
43

bill concerning written care plans and resident
assessments.’ The report states:

The Committee intends that the resident
assessment instrument or instruments developed
by the Secretary have the following
characteristics. First, when used by a trained
observer, the instrument should describe the
capacity of the resident, at the time of
observation, to function independently.
Second, when used by another trained observer
on the same resident at the same time, the
result should be the same as that obtained by
the first observer. Finally, the descriptive
portions of the resident assessment instrument
should be helpful to nursing facility staff in
planning care, but the assessment of the
resident's functional capacity should not be
either prognostic or prescriptive. ...

Because the resident assessment is one of the
critical underpinning at high quality care,
accuracy in describing the functional capacity
and health status of each resident is
essential. To clarify accountability, section
4111 of the Committee amendment would require
that a registered professional nurse sign and
certify the accuracy of each assessment. .. .

H.R. Rep. No. 391, 100th Cong., 1st Sess., part 1, at 465

(1987).

8

These requirements are codified at 42 U.S.C. §

1395i-3(b) (2) and (3).

9

The quoted text appears in the section of the

report in which the congressional committee discusses
Medicaid-certified nursing facilities. The statutory
provisions regarding the resident assessment for

Medicaid-certified nursing facilities are found at 42

U.S.C.

§ 1396r(b) (3). The statutory provisions regarding

the resident assessment for Medicare-certified skilled
nursing facilities are identical and are found at 42
U.S.C. § 1395i-3(b)(3) of the Act. Accordingly, although
the quoted text is referring to nursing facilities
participating in the Medicaid program, I find that it is
applicable to skilled nursing facilities participating in
the Medicare program.
44

The report states, among other things, the committee's
view on physical restraints:

The committee is very concerned about reports
of deaths due to physical restraints, and so to
better protect residents, restraints may only
be imposed to ensure the physical safety of the
resident or other residents and only upon the
written order of a physician that clearly
specifies the duration and circumstances under
which the restraints may be used. However, in
emergency situations, as specified by the
Secretary, to protect the safety of the
resident or other residents in the facility,
the resident could be restrained for a short
period of time until a physician order could
reasonably be obtained. The committee intends
that restraints used in emergency conditions
would be used only in unanticipated situations
and that every effort would be made to obtain a
physician's written order as quickly as
possible.

Id. at 932.

With respect to the survey and certification process, the

report states:

The current survey and certification system has
been in effect since 1974. It focuses on
structural requirements (e.g., written policies
and procedures, staff qualifications and
functions, and physical plant characteristics),
not on resident outcomes (e.g., presence or
absence of bedsores or infections, extent of
cognitive impairment). The IOM Committee
identified a number of major problems with the
current survey process, including
predictability, inefficiency, an emphasis of
paper compliance, insensitivity to resident
needs, inconsistency, and lack of coordination
with ombudsman programs and other monitoring
processes. The IOM Committee urged the
adoption of a resident-centered, outcome-
oriented survey process...

Id. at 466."

10 The committee reference to the IOM Committee

is a reference to the Institute of Medicine (IOM) of the
(continued...)
45
The conference report states:

The conferees also suggest that the Secretary
consider, in establishing criteria by which the
standard survey will measure quality of care
furnished by a facility, such factors as vision
and hearing; activities of daily living; use of
physical restraints; accidents; nutrition and
fluid intake; cognitive, behavioral, and social
functioning; use of urinary catheters;
prevention and care of pressure ulcers; and use
of drugs.

H.R. Conf. Rep. No. 495, 100th Cong., 1st Sess., 715
(1987).

This legislative history demonstrates congressional
intent to implement major reforms in nursing home care
and to create a resident-centered, outcome-oriented
survey process. Congress, moreover, intended to
significantly alter the conditions of participation for
SNFs and to direct the focus and format of surveys
conducted by states to those new conditions of
participation. In fact, the Secretary was directed to

10 (...continued)

National Academy of Sciences, which, at the request of
HCFA, undertook "a study of the policies and regulations
governing the certification of nursing homes
participating in Medicare and Medicaid." The IOM
Committee on Nursing Home Regulation issued a
comprehensive 415-page report in March 1986 titled
“Improving the Quality of Care of Nursing Homes." Id. at
452.

Although the quoted text appears in the section of the
report concerning nursing facilities under Medicaid, I
find that the concerns expressed by the committee
regarding the survey process apply equally to SNFs under
Medicare.

The statutory provisions concerning the survey and
certification process for Medicaid-certified nursing
facilities are found at 42 U.S.C. § 1396r(g). The
statutory provisions concerning the survey and
certification process for Medicare-certified skilled
nursing facilities are identical and are found at 42
U.S.C § 1395i-3(g).
46

develop new survey protocols which were consistent with
the mandates of OBRA '87.

B. FA's rule-maki activities from Ju 7-Nove’
1994

In July, October, and November 1987, HCFA published
proposed rules which dealt with the survey and
certification process, conditions of participation, and
enforcement regulations. 52 Fed. Reg. 24,752, 38,582,
and 44,300.'! While HCFA was considering public comments
on the latter two proposed sets of regulations, Congress
enacted OBRA '87 in December 1987.

In the preamble to the July 1, 1987 proposed regulations,
HCFA stated that it was proposing these regulations in
response to the U.S. District Court decision in Estate of
Smith v. Bowen, 656 F. Supp. 1093 (D. Colo. 1987), in
which the court found that an earlier rule published on
June 13, 1986, titled "Medicare and Medicaid Programs --
Long-Term Care Survey" was procedurally invalid. The
court had ordered HCFA to publish a new proposed rule by
July 1, 1987 addressing the problems which had been
identified. 52 Fed. Reg. 24,752-24,753.

On June 17, 1988, HCFA, acting in accordance with a
February 18, 1988 court order in Smith v. Bowen,
promulgated final regulations amending the Medicare and
Medicaid survey regulations then in effect. These final
regulations were based on the proposed regulations
published in July 1987. 53 Fed. Reg. 22,850 (1988).
Among the new regulations promulgated were 42 C.F.R. Part

u The July 1, 1987 proposed rule was titled
"Medicare and Medicaid Programs; Long Term Care Survey"."
The October 16, 1987 proposed rule was titled "Conditions
of Participation for Long Term Care Facilities." The
November 18, 1987 proposed rule was titled "Survey and
Certification of Health Care Facilities." HCFA intended
that the latter two sets of proposed regulations "would
revamp the long term care requirements under Medicare and
Medicaid to be a resident-oriented system capable of
consistent implementation by States." 53 Fed. Reg.
22,850.

HCFA later withdrew the November 1987 proposed rule. See
57 Fed. Reg. 39,279 (1992) (recited as part of
supplementary background information) .
47

488 Subpart C. The preamble acknowledges Congress'
enactment of OBRA '87:

{a] new survey process is required by OBRA '87,
effective in 1990. In addition, due to the new
statutory provisions, we are withdrawing our
proposed rule on Survey and Certification of
Health Care Facilities (52 FR 44300), and will
publish a new proposed rule incorporating the
OBRA '87 provisions.

RKKKK

We are developing final rules on conditions of
participation for long term care facilities

- . + In the meantime, we are complying with
the court order by publishing these
regulations, and we are planning additional
revisions to the survey process rules at a
later date after we issue a final rule that
revises the conditions of participation.

Id. at 22,850, 22,851.

With regard to survey forms and guidelines, the preamble
emphasizes that

[w]e are deferring major forms design and
content changes to coincide with the planned
refinements in the overall survey process that
will be necessitated in conjunction with the
revised long term care conditions of
participation and the new OBRA '87
requirements. [Id. at 22,856.]

When the new conditions of participation are
published as final regulations, we will make
necessary refinements to the survey process,
forms and guidelines. [Id. at 22,853.]

The preamble notes the breadth of the changes under
consideration:

Although we are publishing this final rule now,
in compliance with the court's order, we are
also in the process of instituting more far-
reaching changes in the nursing home conditions
of participation and enforcement regulations
that underlie the long term care survey
process. [Id. at 22,850.]
48

. . . OBRA '87 and the revised conditions of
participation for long term care facilities
will implement substantive changes to the
nursing home requirements and corresponding
changes to the long term care survey process.
{Id. at 22,851.)

Also, the preamble states unequivocally that the survey
procedures and guidelines being published at that time
were "rooted in the current nursing home requirements
which are the conditions of participation for SNFs. . ."
Id. at 22,853.

HCFA's rule-making activities continued in February 1989,
when it published as final regulations (with a comment
period) a revised version of its October 1987 proposed
rule. 54 Fed. Reg. 5316 (1989). These regulations,
effective August 1, 1989 (except when specified otherwise
in the Federal Register), concerned requirements that
long-term care facilities were required to meet to
participate in the Medicare and Medicaid programs.” In
the preamble, HCFA stated that, "[i]n addition to
numerous technical revisions made by OBRA '87, in this
final rule, we are incorporating the following major OBRA
'87 requirements .. ." 54 Fed. Reg. 5317. HCFA stated
also that it "plan[ned] to publish other, related
regulations in addition to this final rule" to implement
OBRA '87. Id. HCFA stated further that "[(t]his
legislation [i.e., OBRA '87] covered many of the
provisions that appeared in the proposed rule.

Therefore, many of the provisions that we are adopting in
this final rule are now legislative provisions." 54 Fed.
Reg. 5355. Due to the extensive revisions to the
regulations mandated by numerous OBRA '87 provisions,
HCFA published a derivation table setting forth the
source of each of the newly promulgated conditions of
participation contained in the final regulations. 54
Fed. Reg. . 5354-5355.

In September 1991, HCFA published final regulations which
revised the February 2, 1989 final regulations. 56 Fed.
Reg. 48,826 (1991). These 1991 regulations reflected

bea The effective date was later changed to
January 1, 1990. See 56 Fed. Reg. 48,826 (1991).
49

HCFA's response to public comments and included some
changes required by OBRA '90. In the preamble, HCFA
explained:

The February 2, 1989 revision of the nursing
home regulations was the most extensive set of
Federal regulatory changes in this area of the
health care industry in 15 years. We revised
the requirements that long term care facilities
must meet in order to receive Federal funds for
the care of residents who are Medicare
beneficiaries or Medicaid recipients. We
issued the regulations . . . to refocus the
requirements for participation in both programs
to actual facility performance in meeting
residents' needs in a safe and healthful
environment. The previous set of requirements
had focused on the capacity of the facility to
provide appropriate care. In addition, we
needed to simplify Federal enforcement
procedures by using a single set of
requirements that apply to all activities
common to [skilled nursing facilities],
{intermediate care facilities], and [nursing
facilities). ...

OBRA '87 departs from previous Congressional
practice by specifying many details which prior
law leaves to the authority of the Secretary.
It also contains entirely new requirements
which are also specified in detail.

56 Fed. Reg. 48,826.

Based on this preamble language, there can be little
doubt that HCFA was continuing to respond to the
enactment of OBRA '87 by making numerous changes in the
regulatory requirements concerning conditions of
participation and the survey process for long-term care
facilities.

In August 1992, HCFA published proposed regulations which
would further implement provisions of OBRA '87, as
further amended by 1988, 1989, and 1990 legislation. 57
Fed. Reg. 39,278 (1992). With regard to survey
procedures and guidelines, HCFA provided in the preamble
the following background information to the survey
process that existed as of August 1992:

Sections 1819(g)(2) and (3) and 1919(g)(2) and
(3) of the Act, as added by sections 4202 and
4212 of OBRA '87 specify the requirements for
50

types and periodicity of surveys that are to be
conducted for each facility; including
standard, special, partial extended, extended,
and validation surveys. These provisions
include specific contents and procedures,
frequency, consistency, and team composition.
These regulatory provisions are an integral
part of the long term care survey and
enforcement system and along with the
requirements for long term care facilities
published in a final rule on September 26, 1991
(56 FR 48826), and the interpretive guidelines
and survey procedures issued in September .1989,
and revised in April 1992 [emphasis added”],
complete the execution of the long term care
survey and certification process mandated under
OBRA '87. This fully integrated system
provides the comprehensive framework to ensure
uniform surveyor interpretation of substandard
care, and to guide recommendations with respect
to the determination of appropriate remedies.

57 Fed. Reg. 39,283 (1992).

HCFA further described in the preamble the purpose and
framework for the recently published interpretive
guidelines and survey procedures as follows:

The interpretive guidelines and survey
procedures direct the State agency surveyors to
gather information on facility performance
relating to the delivery of care and services
to the residents in the facility. These
surveyor instructions structure the information
gathering process and assist the surveyors in
identifying situations that are indicative of a
facility's compliance with the regulations.

3 Although the passage quoted above does not
contain a specific reference to the State Operations
Manual, Transmittal No. 250, commonly known as SOM 250,
one can infer that HCFA, by mentioning that the
guidelines and survey procedures were revised in April
1992, is referring to this manual. SOM 250 was published
in April 1992. Testimony from the state surveyors makes
evident that they received extensive training from HCFA
and were expected to implement the survey process set
forth in SOM 250 in all surveys conducted after April
1992. See section VI. of this decision, infra.
51

Moreover, the surveyor guidelines provide the
surveyors with a consistent structure to
evaluate the situation and the framework to
analyze the information prior to making a
compliance decision.

+ + « The survey guidelines provide the
surveyors with structured information gathering
procedures and interpretations related to the
requirements that permit the surveyors to make
consistent deficiency determinations. However,
we do recognize that in many instances the
decision with respect to whether a deficiency
exists is ultimately a decision of professional
judgment related to the particular situation
observed and the context of the regulations.
Therefore, to assure consistency, we promote
team decision making and provide comprehensive
training on the regulations and documentation
techniques.

Id.

The language cited above spells out the evolving process
undertaken by HCFA in carrying out the OBRA '87 mandates.
The survey procedures and guidelines in 42 C.F.R. Part
488, Subpart C, were revised by HCFA to comply with
congressional directives in OBRA '87 to develop new
protocols. These protocols were published in April 1992
as SOM 250. While HCFA made no specific reference to SOM
250 in the preamble to the August 1992 proposed
regulations, the scope and purpose of this publication is
also evident. When the proposed regulations were
published in final form in November 1994, with an
effective date of July 1, 1995, HCFA, in response to
comments concerning the variation in surveys conducted by
state and federal surveyors, stated:

[T]he long term care survey protocol has only
been in effect since October 1990, with
appropriate instruction enhancements for the
final long term care regulations which were
effective April 1, 1992. It is not unusual
that some variation in emphasis will occur in a

new survey process [emphasis added}.
59 Fed. Reg. 56,116, 56,145 (1994).
52

Of particular interest to this proceeding is HCFA's
response to a comment that a facility would not know what
was required of it prior to being cited for a deficiency:

There is no reason why any Medicare or Medicaid
provider should be unaware of program
participation requirements. The requirements
are public knowledge, and it is incumbent upon
facilities that enter into Medicare and
Medicaid agreements to familiarize themselves
with the requirements with which they have
voluntarily agreed to comply. Moreover, copies
of the State Operations Manual Transmittal No.
250, which contains the interpretive
guidelines, procedures and forms used by
surveyors to assess facility compliance are
available to the public... {emphasis added].

Id. at 56,227-56,228.

Even though this quoted language from the Federal
Register post-dates the survey of Petitioner in December
1993, HCFA correctly stated that any facility, such as
Petitioner, is expected to know of the regulations
governing its facility and of the interpretive guidelines
governing the conduct of surveyors who measure the
facility's compliance with such regulations. As of
December 1993, Petitioner had been the subject of prior
state surveys and was or should have been on notice as to
the requirements imposed by OBRA '87 on SNFs.

HCFA referred to SOM 250 in several instances when
responding to public comments. For example, on the topic
of a facility's attempt to accommodate a resident in
terms of care alternatives, HCFA responded, in part,
"(w]e believe such specific instructions are more
appropriately located in the State Operations Manual than
in the regulation itself, so we are not incorporating
them into the regulation." 59 Fed. Reg. 56,134. In
responding to another comment on the topic of nursing
services staff, HCFA said: "(w]e do specifically address
a review of staffing in Appendix P of the State
Operations Manual Transmittal No. 250." Id. HCFA again
directs attention to Appendix P of the SOM 250 when it
discusses audits, reiterating its belief that "such
detailed instruction is more appropriate in the manual
than in the regulation itself, and so we are not
including it in the regulation." 59 Fed. Reg. 56,135.
53

The preamble addresses also survey protocol and instances
where there may have been a failure to completely comply
with such protocol. HCFA stated:

Sections 1819(g)(2)(C) and 1919(g)(2)(C) of the
Act reveal the intent of the Act very clearly.
These sections state that standard surveys must
be conducted based upon a protocol, but add
that the failure of the Secretary to develop,
test or validate such a protocol will not
relieve any State or the Secretary of the
responsibility to conduct surveys. Because the
Congress intended for survey results to be
binding even when surveys were conducted in the
absence of a formal protocol, it is clear that
the Congress views the substance of survey
findings to be of greater importance than the
process used to identify them.

59 Fed. Reg. 56,133-56,134 (emphasis added).
HCFA further stated:

Moreover, since the source of binding
requirements on facilities is not in the survey
protocol, but in the Act and regulations, the
ultimate, and proper, test of facility
noncompliance will not rest on whether the
survey protocol was rigorously followed, but on
whether a requirement of the Act or the
regulations has been violated.

Id. at 56,134.

While these explanations of HCFA's intentions regarding
the interplay between 42 C.F.R. Part 488, Subpart C, and
SOM 250 post-date the survey in issue in this case, they
are instructive in understanding HCFA's position and
providing guidance in construing the application of
Subpart C and the survey protocols in SOM 250.

As illustrated by the foregoing section, HCFA's efforts
to carry out the statutory mandates of OBRA '87 thus
spanned several years following its enactment. It is
evident that to successfully implement the provisions of
OBRA ‘87, HCFA was required to revise, rewrite, and add
numerous regulations. It is also apparent that the June
1988 final regulations, which included 42 C.F.R. Part
488, Subpart C, were promulgated by HCFA with great
reluctance and only after being mandated by the court.
An obvious concern of HCFA was the evolving process by
which it was implementing the provisions of OBRA '87 and
54

the need to develop a mechanism which provided
flexibility and allowed for revisions in instructions to
state agencies without the need to institute formal
rulemaking every time changes were necessary.

c. Analysis

In determining the present force and effect of the survey
procedures in 42 C.F.R. Part 488, Subpart C, I am guided
by the fact that those survey procedures and guidelines
were the subject of lengthy deliberations by HCFA,
involving several separate Federal Register
pronouncements, with all of these activities predating
the effective date of OBRA '87. Equally persuasive is
the fact that the Federal Register statement accompanying
the final publication of Subpart C leaves no doubt that
1) this Subpart pertained to conditions of participation
for long-term care facilities that were in effect at the
time of publication and 2) HCFA was, at the time of
publication, in the process of making significant and
wide-ranging changes to the existing conditions of
participation based on various amendments to the law,
principally OBRA '87.

A review of Subpart C survey procedures demonstrates that
they do not reflect the new and expanded requirements
created by OBRA '87, including those in the areas of
residents' rights, quality of patient life, quality of
care, and dietary, dental, pharmacy, nursing and
physician services. See 42 U.S.C. §§ 1395i-3(b)-(d),
1396r-3(b)-(d); 42 C.F.R. § 483.10 - 483.75; 54 Fed.
Reg. 5354-5355 (1989). Moreover, the above cited
references to the Federal Register demonstrate that HCFA
put SNFs on notice as early as August 1992 that the
interpretive guidelines and survey procedures used in
federal and state surveys were revised in April 1992. At
the time of the December 1993 survey, Petitioner was
bound by these survey protocols and by the applicable
regulations pertaining to the conditions of participation
set out in 42 C.F.R. Part 483, Subpart B.

I concur with HCFA's position that Subpart Cc is
inconsistent with and does not implement the OBRA '87
revisions to the health and safety requirements that a
long-term care facility must meet to participate in the
Medicare and Medicaid programs. HCFA Resp. Br. at 56-58.
Subpart C, while technically still in effect, does not
have any current operational significance since it
pertains to survey methodology and conditions of
participation which became obsolete with the
implementation of the new conditions of participation and
55

survey processes mandated by OBRA '87, which did not go
into effect until October 1990."

The legal underpinning for Subpart C no longer exists.
Congress directed the Secretary to develop new survey
protocols to implement OBRA '87. Subpart C has been
replaced by these protocols. HCFA's failure to withdraw
Subpart C and to formally publish the revised protocols
in regulations does not elevate outdated, obviously
obsolete survey procedures and guidelines (Subpart C) to
a legal status which is inconsistent with congressional
intent.) Moreover, Congress was cognizant of the

“ HCFA points to Estate of Smith v. Sullivan,
(D. Colo. 1990) for support of the position that Subpart
Cc was rendered obsolete by the passage of OBRA '87. HCFA
Resp. Br. at 56. In this case, the court ordered,
effective October 1, 1990, that the "Secretary shall be
permitted on an interim basis to require the use of the
new survey forms, procedures and interpretive guidelines"
and Subpart C "shall be suspended but not repealed
pending further orders of this Court. . ." HCFA
Attachment 2. (I discuss this order further in section
V. of this decision). HCFA contends that the new survey
forms, procedures and interpretive guidelines are those
outlined by SOM 250. HCFA Resp. Br. at 56. I am
convinced that this district court case demonstrates that
HCFA was implementing OBRA '87 by means other than
Subpart C but based on this interim court order, HCFA
could not repeal that Subpart. Certainly, HCFA could
have dispelled any confusion about the operational
validity of Subpart C by publishing in the Federal
Register a specific statement relating to Subpart c.
Unfortunately, this was never done. That failure,
however, cannot be used to validate the survey process in
Subpart C, which process HCFA was required to replace
with the implementation of OBRA '87.

5 It is noteworthy that a simple reading of the
chart found at 42 C.F.R § 488.115 demonstrates an
internal inconsistency, for the regulations referenced in
the chart pre-date OBRA '87, and, thus, have been made
inert by Congress and by HCFA's rule-making activities.
The referenced regulations are outdated and no longer in
existence today. Accordingly, it would be impossible to
"apply" this chart to any surveys which were conducted
post-OBRA '87. A review of the derivation table
published in the Federal Register leaves no doubt that
the regulations referenced in the chart at 42 C.F.R. §
488.115 were superseded by the new regulations published

(continued...)
56

possibility that the Secretary would not develop the
survey protocols by January 1, 1990 and directed the
states and Secretary to carry out the mandates of OBRA in
the absence of such protocols. See section IV.A. of this
decision, supra.

Apparently ignoring the cited statutory language,
legislative history, and statements by HCFA in
publications of the Federal Register post-OBRA '87,
Petitioner argues that the "(e]nactment of OBRA 1987 has
not changed a single regulatory requirement for the
conduct of surveys." P. Resp. Br. at 3. This position
is so totally inconsistent with the record in this case
that I do not give it any serious consideration. One
argument Petitioner appears to make is that the OBRA '87
requirement that each survey include a "case-mix
stratified sample of residents" does not change any
requirement of Subpart C. Id." This is incorrect. 42
C.F.R. § 488.110(d) (which is found in Subpart C) refers
to a random sample and not the case-mix stratified sample
which is required by OBRA '87." Thus, Petitioner's own
reference demonstrates that Subpart C, as I have found,
does not track or adhere to the requirements of OBRA '87.
HCFA's counsel gives other examples of the inconsistency
between OBRA '87 requirements and 42 C.F.R. § 488.110 in
her reply brief at pages 34-35.

As previously stated in this decision, there is ample
support for the conclusion that OBRA '87 made substantial
changes in the conditions of participation and survey
process for long term care facilities. The statute
itself reflects this and HCFA's extensive analyses of
OBRA '87 in the Federal Register leave no doubt as to its
interpretation of the impact of OBRA '87 on then-existing
statutory and regulatory requirements.

Petitioner further argues that 42 C.F.R. § 488.110 is
binding on HCFA and the survey protocols and definitions
contained therein were operative at the time Petitioner
was surveyed in December 1993. In support of this

iS (...continued)
in February 1989, which became effective on August 1,
1989. See 54 Fed. Reg. 5316, 5356-5358.

16 Unfortunately, Petitioner's brief is garbled
on this point and I am therefore forced to interpret the
confused language. P. Resp. Br. at 3-4.

” I discuss resident selection methodology
further in Section IX of this decision.
57

position, Petitioner points out that 1) HCFA never
formally withdrew 42 C.F.R. § 488.110 after OBRA '87 was
enacted, and 2) all volumes of the Code of Federal
Regulations (C.F.R.) for the years 1992 to the present
continue to contain this Subpart without revision.
Petitioner concludes that, since Subpart C is the
operative standard for the conduct of surveys under OBRA
‘87 and HCFA did not follow this standard in conducting
the survey of Petitioner in December 1993, the survey
results are a nullity and cannot be used to delay its
certification for Medicare. P. Resp. Br. at 4-6.

There is no dispute of the obvious fact that, despite
OBRA '87, HCFA has never formally withdrawn 42 C.F.R.
Part 488, Subpart C and has continued to publish it in
the C.F.R. This circumstance presents several legal
issues which I will now address.

v. Issue:
Whether HCFA was legally required to formally

withdraw or repeal 42 C.F.R. Part 488, Subpart
c.

Petitioner contends that HCFA never formally repealed 42
C.F.R. § 488.110 (which is included in Subpart Cc) in
accordance with the requirements of the Administrative
Procedure Act (APA), and that its failure to do so makes
the agency bound by the contents therein. P. Br. at 15.
Petitioner argues also that the fact that Subpart C was
recently re-published, without any changes, in the C.F.R.
is indicative of its present-day validity. P. Resp. Br.
at 5.

HCFA claims that Subpart C was inconsistent with and did
not carry out the directives of OBRA '87 and, thus, lost
operational significance "as a matter of law." HCFA
Resp. Br. at 58. HCFA contends that, with the enactment
of OBRA '87, "the survey forms, procedures, and
guidelines of Subpart C were nullified: administrative
repeal was not required." Id. at 60.

I find that HCFA was not legally required to formally
withdraw or repeal Subpart C in order for this subsection
to be rendered inoperative by the passage of OBRA '87,
the provisions of which became effective on October 1,
1990.

In examining the interrelationship between administrative
regulations, statutory language, and congressional
intent, the Supreme Court has expressed the well-settled
principle that congressional desire discerned from a
58

statute is to be effectuated through promulgated
regulations:

[t]he power of an administrative officer or
board to administer a federal statute and to
prescribe rules and regulations to that end is
not the power to make law. . . but the power
to adopt regulations to carry into effect the
will of Congress as expressed by the statute.
A regulation which does not do this, but
operates to create a rule out of harmony with
the statute, is a mere nullity.

attan Genera wi Cc v issione
Internal Revenue, 297 U.S. 129, 134 (1935). Ina later
case, the Court again recognized that "regulations, in
order to be valid, must be consistent with the statute
under which they are promulgated." U.S. v. Larionoff,
431 U.S. 864, 873 (1977). Also, a regulation is invalia
if it is "fundamentally at odds with the manifest
congressional design," even if it is not "technically
inconsistent" with the statutory text. U.S. v. Voge
Fertilizer Co., 455 U.S. 16, 26 (1982).

There is no dispute that the contents of Subpart C were
never modified and that HCFA never formally repealed or
withdrew Subpart C. It follows logically that, because
Subpart C was never formally repealed, HCFA was required
to re-publish this section in the C.F.R. However, the
mere fact of publication has little bearing on the issue
of whether this subpart has any operational significance
today. In light of the principles enunciated above by
the Supreme Court, the appropriate analysis begins by
focusing on the congressional purpose in enacting OBRA
"87.

As discussed previously, the legislative history of OBRA
'87 demonstrates that Congress intended to make far-
reaching changes in the survey and certification process
to remedy shortcomings in the law as it then existed.
Moreover, the legislative history underscores
congressional intent to create a patient-centered,
outcome-oriented survey process. It is fair to conclude
that the intent of Congress, as expressed in the
legislative history of OBRA '87, is unambiguous.

As discussed earlier in section IV. of this decision , I
find that OBRA '87, imposes many new requirements on long-
term care facilities. These provisions explicitly carry
out the congressional objective of comprehensive nursing
home reform. I conclude that the contents of Subpart C
became obsolete with the implementation of the OBRA '87
59

provisions (section IV., supra). Subpart C did not
address the new conditions of participation and survey
processes statutorily mandated by OBRA '87. Based on
this, it cannot be disputed that Subpart C is "out of
harmony" with OBRA '87 and, thus, at odds with the will
of Congress. To give any effect to Subpart C would
clearly frustrate the congressional purpose in passing
OBRA '87. Moreover, "(w]here an administrative
regulation conflicts with a statute, the statute
controls." U.S. v. Doe, 701 F.2d 819, 823 (9th Cir.
1983). Subpart C must thus be considered to have lost
any operational significance by virtue of the fact that
it conflicts with, and does not carry out, the directives
of OBRA '87.

I agree with HCFA that formal repeal of Subpart C was not
required. Petitioner cites to the case of Am. Fed'n. of
Gov't. Employees v. Fed. Lab. Rel. Auth., 777 F.2d 751,
(D.c. Cir. 1985), among others, in support of its
argument that Subpart C should have been repealed in
accordance with the APA rule-making process:

"C(A]n agency seeking to repeal or modify a
legislative rule promulgated by means of notice
and comment rulemaking is obligated to
undertake similar procedures to accomplish such
modification or repeal... .

Id. at 759.

However, the Supreme Court decisions cited above make no
mention of formal repeals in the instances where a
regulation does not effectuate the congressional design.
For example, the Court has held that certain Defense
Department regulations conflicted "with the congressional
intention in enacting the VRB program, and hence [are]
invalid." U.S. v. Larionoff, 431 U.S. at 877. The
absence of any explicit reference by the Court regarding
repeal gives rise to the inference that such regulations
are to be found null, and thus, invalid. Furthermore,
because the Court in Larionoff did not refer at all to
APA requirements in declaring the regulations to be
invalid, I infer that such requirements do not have to be
met. Even without this interpretation, it can be argued
that the import of repealing the regulation is to provide
notice to the public that the agency is no longer relying
on such regulation in carrying out the congressional
mandate upon which the regulation is based. Here, the
Federal Register references previously cited in section
Iv., reflect the fact that HCFA specifically and clearly
notified the public that the survey protocols and
procedures in Subpart C were replaced by SOM 250.
60

In any event, in the matter before me, it appears that
HCFA was prohibited from repealing Subpart C based on the
interim order issued by the federal court in Colorado in
the case of Estate of Smith v. Sullivan, on September 27,
1990. The order stated, in part: "Effective October 1,
1990, the Secretary shall be permitted on an interim
basis to require the use of the new survey forms,
procedures and interpretive guidelines described above.
The current regulations providing certification survey
forms and guidelines, 42 C.F.R. Part 488, Subpart C,
shall be suspended but not repealed pending further
orders of this Court ... " HCFA Attachment 2 at 1, 3.
Thus, HCFA could not repeal Subpart C; nevertheless, it
was allowed by the court to use the new survey protocols.
Any alleged non-conformity with the requirements of the
APA on HCFA's part is therefore moot in light of the

- court's interim order.

Accordingly, because Subpart C conflicts with the
congressional design underlying OBRA '87, it became void
of any effect and validity; it was rendered "a mere
nullity" as a matter of law, without necessitating a
repeal or withdrawal by any formal means.

I find unpersuasive Petitioner's argument that HCFA has
acted in disregard of its own rules. Petitioner cites
Morton v. Ruiz, 415 U.S. 199, 235 (1974), as well as
other cases, for the proposition that "{a]dministrative
agencies are under an obligation to observe their own
regulations." P. Br. at 12. This general statement of
law cannot be disputed. But what Petitioner ignores is
that such general statement cannot be applied to
circumstances where the regulation in issue no longer
carries out the will of Congress and has been replaced by
other administrative directives, such as SOM 250.

Here, HCFA has followed its regulations, procedures, and
precedents. Because Subpart C became null and void and,
thus, without any operative effect, HCFA's departure from
this subsection was justified. The order of remand
issued by the Appeals Council of the Social Security
Administration in Health Care Financing Administration v.
Devon Gables th Care Center (Dec. 7, 1994), further
supports HCFA on this point. In stating the background
of the case, the Appeals Council first explained that the
administrative law judge in the case had held that

the survey process and subsequent findings resulting
therefrom are invalid as a matter of law, given that
(HCFA}] did not follow its own binding regulations
61

relating to the survey process, as contained in 42
C.F.R. Part 488, Subpart C.

HCFA Attachment 3 at 3."

The Appeals Council concluded that the administrative law
judge had erred in finding the survey process and
subsequent findings to be invalid:

Under the Administrative Procedure Act, an
Administrative Law Judge is subordinate in
matters of policy to the Secretary of Health
and Human Services. The Secretary, acting
through the Administrator of HCFA, determined
that OBRA '87 and 42 C.F.R. Part 488, Subpart C
are not consistent, and made the policy
decision to give effect to the pertinent
provisions of OBRA '87 by means of interpretive
manuals, procedures and statements of policy
which have not been published as regulations.
The Secretary further determined to apply
nationwide the September 27, 1990 Smith court
order which suspended 42 C.F.R. Part 488,
Subpart C, and required use of the unpublished
forms, procedures and interpretive guidelines
in order to implement the changes mandated by
OBRA '87.

HCFA Attachment 3 at 4.

The legal and factual basis of the remand order issued by
the Appeals Council is consistent with my analysis of
this case.” Further support for the position can be

8 In his decision dated August 21, 1992, the
administrative law judge had stated the issue "as being
whether the Health Care Financing Administration's (HCFA)
failure to follow and apply the survey process set forth
in 42 C.F.R., Part 488, Subpart C, and the use of
unpublished survey procedures and materials as contained
in Appendix P of the State Operations Manual and the HCFA
Self-Instructional Manual, rendered the survey findings
and HCFA's January 11, 1991 certification of non-
compliance invalid as a matter of law." HCFA Attachment
3 at 2.

1% The Appeals Council in Devon Gables stated
further:

(continued...)
62

inferred from the fact that the regulations found in this
Subpart refer to other regulations that are outdated and
no longer exist. For example, as a result of the
numerous and substantial revisions to the regulations
concerning conditions of participation and other
requirements mandated by OBRA '87, the regulations
referenced in the chart at 42 C.F.R. § 488.115 were made
inert by Congress and by HCFA's own rule-making
activities. These referenced regulations, which pre-date
OBRA '87, no longer have any viability, for they are no
longer in existence. (See fn 15 for a discussion of this
chart.)

Having recognized that Subpart C was contrary to OBRA
'87, the Secretary thus chose to effectuate the OBRA '87
provisions by means of "unpublished forms, procedures and
interpretive guidelines." It is noteworthy that the
Appeals Council's reference to the unpublished materials
is a reference to the contents of Appendix P of the State
Operations Manual (250) and, also, the HCFA Self-
Instructional Manual. HCFA Attachment 3 at 2; see fn 18.
Thus, HCFA's use of the SOM 250 in place of the now-
obsolete Subpart C complied fully with the Secretary's
policy decision and was consistent with its obligation to

9 (...continued)

The manner in which the Secretary selects to
implement the Congressional mandate in order to
both effectuate the will of Congress and comply
with the Court's directives in the Smith
litigation is not subject to review by an
Administrative Law Judge. The Council can
discern no authority for the Administrative Law
Judge to rule on the validity or invalidity of
a regulation or interpretive rule.

HCFA Attachment 3 at 4.

I do recognize that I do not have authority to declare a
regulation invalid. David S. Muransky, DAB CR95 (1990),
aff'd DAB 1227 (1991); Hanlester Network, et al., DAB
CR181 (1992); Charles J. Barranco, DAB CR187 (1992).
However, despite this admonition, in fairness to
Petitioner, I have carefully examined its position and
responded to the issues raised by Petitioner regarding
the operational effect of 42 C.F.R. Part 488, Subpart C.
My analysis as to the operational effect of Subpart C is
based on the actions taken by the Secretary in carrying
out her responsibilities under OBRA '87 and not on my own
interpretation of the legality of these regulations.

63

abide by its own rules and regulations. Accordingly,
HCFA did not violate any administrative norm by its non-
adherence to the survey procedures and guidelines
contained in Subpart c.”

Furthermore, this case is distinguishable from Morton v.
Mancari, 417 U.S. 535, 549 (1974), in which the Court,
quoting Posadas v. National City Bank, 296 U.S. 497, 503,
(1936), stated that "repeals by implication are not
favored." In Morton v. Mancari, the Court considered the
issue of whether the Indian employment preference in the
Bureau of Indian Affairs contained in the Indian
Reorganization Act was impliedly repealed by the Equal
Employment Opportunity Act of 1972. As part of its
analysis, the Court stated that "{iJn the absence of some
affirmative showing of an intention to repeal, the only
permissible justification for a repeal by implication is
when the earlier and later statutes are irreconcilable."
Id. at 550. The Court found that the employment
preference was not impliedly repealed by the 1972 Act.

Here, unlike Morton v. Mancari, the issue is not whether
one statute conflicts with another statute, but whether
promulgated regulations conflict with the intent of
Congress as expressed in a specific statute, namely, OBRA
'87. As.I discussed above, Subpart C did not address or
implement the new requirements contained in OBRA '87
affecting nursing homes and the survey process. This
being the case, Subpart C was rendered void and without
operative effect. Using the analysis of Morton v.
lancari, the record demonstrates that Subpart C is
irreconcilable" with the requirements of OBRA '87 and is
arguably repealed by implication.

Furthermore, HCFA, through the previously enumerated
cited sections in the Federal Register, made its position
quite clear concerning the applicability of Subpart C.
Notice was given to SNFs that, in implementing the
federal requirements covering the conduct of long-term
care facilities, the Secretary no longer was relying on
the survey protocols and procedures set forth in Subpart
c. I have no authority to question that decision or
second guess the Secretary.

20 I discuss the operational significance of the
SOM 250 in section VI. of this Decision.
64

vi. ssue:

Whether SOM 250 is applicable to the survey of
Petitioner.

Petitioner contends that, to the extent that SOM 250
alters the substance of Subpart C, HCFA was required to
promulgate the provisions of SOM 250 in accordance with
the rulemaking requirements of the APA; otherwise, such
requirements would be invalid. P. Br. at 17-20.

I do not agree that, because HCFA did not issue SOM 250
in the form of a formal regulation, it is null and void .
The provisions of SOM 250 are not "substantive," but
"interpretive". Alcarez v. Block, 746 F.2d 593, 613 (9th
Cir. 1984); American Hospital Association v. Bowen, 834
F.2d 1037, 1045 (D.C. Cir. 1987); Guadamuz v. Bowen, 859
F.2d 762, 771 (9th Cir. 1988). HCFA published SOM 250 to
provide guidance to state surveyors who are responsible
for determining compliance by long-term care facilities
with federal requirements imposed by statute and
regulations. The following references in SOM 250 set
forth HCFA's purpose in disseminating this document to
state agencies:

2712. USE OF THE SURVEY PROTOCOL IN THE
SURVEY PROCESS

[Survey protocols] are the authorized
interpretations of mandatory requirements set
forth in provisions of the Social Security Act
-» . +, and in the regulations.

Survey protocols identify relevant areas and
issues to be surveyed as specified in each
regulation, and, in some cases, the methods to
be used to survey those areas and issues.
These protocols promote consistency in the
survey process. They also assure that a
facility's compliance with the regulations is
reviewed in a thorough, efficient and
consistent manner. . .

Included in the survey protocols are
Interpretive Guidelines which serve to
interpret and clarify the conditions of
participation, conditions for coverage, and
requirements of participation for specific
types of entities. The Interpretive Guidelines
contain authoritative interpretations and
clarifications of statutory and regulatory
requirements and are to be used to make
65

determinations about a provider's compliance
with requirements. These Interpretive
Guidelines merely define or explain the
relevant statutes and regulations and do not
impose any requirements that are not otherwise
set forth in the statute or regulations. ...

RRRKE
2803. SURVEY PROTOCOL

A. Introduction.-- This protocol is
established pursuant to §§ 1819(g)(2)(C) and
1919(g) (2) (C) of the Act to provide guidance to
surveyors conducting surveys of long-term care
facilities participating in the Medicare and
Medicaid programs. The protocol consists of
survey procedures, work sheets and Interpretive
Guidelines. It serves to explain and clarify
the requirements for long-term care facilities
and is required to be used by all surveyors
measuring facility compliance with Federal
requirements. The purpose of this protocol is
to provide suggestions, interpretations, check
lists, and other tools for . .. use both in
the preparation for the survey and. . . onsite
performing the survey{.] These Interpretive
Guidelines merely define or explain the
relevant statutes and regulations and do not
impose any additional costs or place other
burdens on any health care facility. (See §
2712.)

HCFA Ex. 13 at 2-137, 2-183.

Since SOM 250 was not intended to "impose any
requirements that are not otherwise set forth in the
statute or regulations," HCFA would not need to formally
publish these instructive guidelines to state surveyors
in the form of a regulation. Consequently, SOM 250 must
be read in connection with the statutory and regulatory
provisions regarding SNFs to determine the operative
protocols, definitions, and standards that were
applicable at the time of the survey in issue. I
conclude that the appropriate approach is to review the
relevant statutory provisions, regulations, and
interpretative guidelines of HCFA as a whole in
determining whether HCFA can support the deficiencies
cited in the Statement of Deficiencies, i.e., HCFA 2567.
66

Petitioner would have me, as the adjudicator, alter the
focus of the hearing from whether deficiencies exist to
whether the state surveyors complied with the applicable
survey protocols. The focus of this hearing is on
Petitioner's practices in operating its SNF and whether
those practices resulted in deficiencies arising from the
requirements of 42 C.F.R. Part 483, Subpart B,
Requirements for Long Term Care Facilities.

HCFA recognized that Congress, in enacting OBRA '87, did
not intend for survey procedures, in and of themselves,
to be elevated above surveyors' legitimate findings of
deficiencies. HCFA states, "[t]o invalidate legitimate
determinations of noncompliance and leave them
unaddressed would be in opposition to the mandate of OBRA
'87 that all requirements be met and enforced, and would
lead to inconsistent application of the law." 59 Fed.
Reg. 56,133. To allow deficiencies that are "otherwise
well documented" to be challenged and possibly
invalidated merely because a surveyor did not comply with
“every last detail of the survey protocol" would, in
HCFA's view, “be surrendering all substance to form and
would clearly thwart Congressional will." Id.

Moreover, it is noteworthy that, although Petitioner
vigorously argues in its briefs that the surveyors acted
in disregard of proper survey procedures in adhering to
the directives contained in SOM 250, counsel for
Petitioner had expressed the following opinion at the in-
person hearing:

Whatever HCFA instructed them to use, assume it
was SOM 250, whatever her boss, "her" being Ms.
Downing's boss at the time, instructed her to
use, assume it was SOS [sic] 250, assume it was
a piece of toilet paper, it's irrelevant. The
only standard by which this case is going to be
judge [{sic] is whether or not the 2567 and
whatever is being written up does or does not
state violations that amount to deficiencies
within the meaning of 42 C.F.R. 540(N) [sic].
The fact that they internally either did or
didn't give correct instruction, they did or
didn't perform an adequate survey, it's
immaterial. Either there's a violation within
the meaning of the regulation and proof that
supports it or there isn't. It doesn't make
any difference if they were instructed properly
or improperly. We're not concerned with that.
We're only concerned here with whether or not
the regulations have been violation [sic],
because that's what's set forth in the 2567,
67

and, if so, whether there's been any proof,
among the other issues, but that's all. There
isn't any other standard. There's nothing here
in this 2567 about SOM 250.

Tr. 2134-2135.

In the quoted colloquy above, Petitioner contends, at
length, that whether or not the survey was performed
adequately is "immaterial" and that the only "standard"
is whether or not the 2567 states "violations that amount
to deficiencies." Petitioner, by later arguing in its
briefs about the non-applicability of the SOM 250 to the
survey, attempts to have it both ways. While I disagree
with Petitioner as to the non-applicability of SOM 250 to
this case for the reasons I previously cited, I do agree
that the ultimate determination as to whether a
deficiency exists will depend on the contentions in HCFA
2567 and proof offered by the parties. As I have
discussed earlier in section IV.B of this decision, this
interpretation is consistent with HCFA's own
interpretation of its responsibilities in carrying out
the congressional intent behind the enactment of OBRA '87
and of the corresponding responsibilities of SNFs who are
or seek to be Medicare providers.

VII. Issue:

Whether 42 C.F.R. § 489.13 permits HCFA to deny
certification on the date the survey is
completed if all Level A requirements are met
and only Level B deficiencies exist.

The regulation at 42 C.F.R. § 489.132 states:
Effective date of agreement.

(a) All Federal requirements are met on the date of
the survey. The agreement will be effective on the
date the onsite survey is completed (or on the day
following the expiration date of the current
agreement) if, on the date of the survey, the

a I am quoting this regulation as it was

published in the 1992 version of the C.F.R. This
regulation was subsequently amended in the 1994
publication of the C.F.R. However, Petitioner was
surveyed in December 1993, prior to the time the 1994
changes were in effect. Therefore, the controlling
regulation on this issue is the one that was in effect at
the time of the survey, i.e., the 1992 version.
68

provider meets all Federal health and safety
conditions of participation or Level A requirements
(for SNFs), and any other requirements imposed by
HCFA.

(b) 1 Federa uireme: t met on t! late
of the survey. If the provider fails to meet any of
the requirements specified in paragraph (a) of this
section, the agreement will be effective on the
earlier of the following dates:
(1) The date on which the provider meets all
requirements.
(2) The date on which the provider submits a
correction plan acceptable to HCFA or an
approvable waiver request, or both.

At issue in this case is the interpretation of this
regulation. The parties do not disagree that 42 C.F.R. §
489.13 requires Petitioner to be in compliance with Level
A requirements on the date of the survey. However,
Petitioner contends that it is virtually "impossible to
be in 100 percent compliance with the myriad regulations
governing skilled nursing facilities." P. Br. at 4.
According to Petitioner, a single violation, such as a
"dirty plate, failed light bulb, unmade bed, late meal,
or documentation error, can all violate some regulation
governing skilled nursing facilities." Id. at 5.
Therefore, Petitioner argues that it is "inconceivable
that [42 C.F.R.] § 489.13 was intended to require 100
percent compliance with "every single regulation as a
condition of certification." Id. As such, Petitioner
interprets 42 C.F.R. § 489.13 as requiring that
Petitioner can be denied certification only when it fails
to meet a Level A requirement or, alternatively, when
"the Level B deficiencies are of a sufficient number or
type so as to render the facility in non-compliance with
a Level A requirement." Id.

HCFA contends that the "any other requirements" language
contained in the regulation refers to Level B
deficiencies, or for that matter any other requirement
imposed upon SNFs by regulation. Accordingly, HCFA's
position is that, under the regulation, it may impose any
additional requirement on SNFs as necessary to insure the
health and safety of the program beneficiaries. HCFA Br.
at 13.

HCFA's position is supported by the plain meaning of the
regulation, as well as by regulations which were
promulgated to implement the OBRA '87 changes to
requirements for SNFs. The plain meaning of 42 C.F.R. §
489.13 is that the phrase "any other requirements" means
69

just that. While the regulation does not define what is
meant by "any other requirements", Administrative Law
Judge Steven Kessel has interpreted the "any other
requirements" language to mean "all conditions,
standards, and elements established as prerequisites for
certification." Transitional Hospitals Corporation --
Las Vegas, DAB CR350, at 8 (1995). In other words, a
provider must meet all requirements imposed upon it by
HCFA before it can be certified. Id.; .

St. Mary's Parish Dialysis Center, DAB CR341, at 5
(1992). This interpretation is in accord with the plain
meaning of the regulation and is supported by the
regulations that have been promulgated to implement OBRA
"87.

Petitioner argues that "[i]f HCFA intended that a
provider was required to meet every last regulation,
irrespective of the severity of the violation or the
number, then it would have so stated." P. Br. at 6.
However, the explanatory material contained in the
preamble to the regulations that enacted 42 C.F.R. §
489.13 contains comments on this very point.

Comment: Two commentors asked for further
clarification of the phrase "all Federal
requirements are fully met" in § 405.606(d).”% In
particular, they asked whether "requirements"
include factors and elements which, though not met,
do not put the provider out of compliance with the
pertinent standard.

Response: The final regulations have been revised
to specify that "all Federal requirements" includes
the health and safety requirements [conditions,
standards, factors, and elements), financial
interest disclosure, and the civil rights provisions
of 45 C.F.R. Parts 80, 84 and 90.

45 Fed. Reg. 22,933, 22,934 (1980).

Additionally, many regulations have been published
subsequent to OBRA '87 that unequivocally state that SNFs
are required to comply with each and every regulatory
requirement. On February 2, 1989, HCFA published final
regulations (effective August 1, 1989, except where
specified otherwise) and solicited comments. 54 Fed.
Reg. 5316 (1989). The regulations revised and
consolidated the requirements for long term care

» This section is the former codification of 42
C.F.R. § 489.13.
70

facilities (including SNFs). Id. These regulations
declared, in effect, that all regulatory requirements
were to be enforced to the fullest extent possible, not
just the more serious Level A type of deficiencies.

{W]e wish to be certain that the public realize that
all requirements for certification must be met by
nursing facilities if they are to avoid some measure
of adverse action. We believe that, to the extent
that Federal requirements were set forth in what
appeared to be a qualitative hierarchy, that there
might be some misunderstanding that violations of
the "lesser" requirements would not be subject to
Federal enforcement.

Additionally, the OBRA '87 requirements have recast
substantive requirements so as not to use the
traditional "conditions" and "standards"
terminology.

Accordingly, in this final rule, we have attempted
where appropriate to retain the organization of the
various proposed requirements, but have revised the
terminology. Thus, those requirements that
previously were identified as conditions of
participation (appearing as individual sections
within a subpart) are now designated as level A
requirements. Those requirements that previously
were identified as standards (appearing as
individual paragraphs within a section) are now
designated as level B requirements. These
designations are intended to communicate that all of
the nursing facility requirements are binding and
are not part of a qualitative hierarchy, while at
the same time recognizing that violations of these
requirements (depending on their type or severity)
may be remedied through the different enforcement
mechanisms available to the Department.

54 Fed. Reg. 5317-5318.

In the preamble addressing the resident rights
requirement, the authors of the preamble stated that
"Since we do not use the "condition of participation" or
"standard" terminology any longer, and we are committed
to enforcement of all requirements equally, we do not
think the title used to describe resident rights will
bring about less or greater enforcement." 54 Fed. Reg.
5318-5319.
71

Emerging from these regulations, which were drafted as
requirements for long-term care facilities under OBRA
‘87, is a clear picture of a mechanism of enforcement in
which there is no hierarchy of violations; that is, every
violation that is committed by a long-term care facility
is to be taken seriously and is to provide a potential
basis for enforcement. This picture clearly accords with
HCFA's view of how the regulations are to be applied in
this case and does not accord with Petitioner's
interpretation of the regulatory requirements in 42
C.F.R. § 489.13. Petitioner's contentions that 42 C.F.R.
§ 489.13 does not require 100 percent compliance with
every single regulation as a condition for certification
and permits HCFA to deny certification only when
Petitioner fails to meet a Level A requirement, or,
alternatively, when the "Level B deficiencies are of a
sufficient number or type so as to render the facility in
non-compliance with a Level A requirement" (P. Br. at 5),
are without merit.

Further support for this position can be found in
subsequent preambles of the regulations implementing the
OBRA '87 requirements and published in the Federal
Register. For example, as I discussed earlier in section
Iv., in 1991, HCFA published final regulations which
revised and consolidated the 1989 regulations. 56 Fed.
Reg. 48,826. These regulations were effective as of
April 1, 1992.

In the preamble accompanying these regulations, HCFA
reiterated that long term care facilities, including
SNFs, were subject to enforcement for all violations of
requirements and that "{iJt was never intended that the
Level A and Level B designations imply a hierarchy of
importance." 56 Fed. Reg. 48,827. The preamble text
went on to state that a long-term care facility
(including an SNF)

must be in compliance with all the requirements of
sections 1819(b) through (d) and 1919(b) through (d)
in order to participate in the Medicare and Medicaid
programs.

Every requirement in these regulations must be
enforced and penalties must be assessed in
accordance with regulations issued pursuant to
sections 1819(h) and 1919(h) of the Social Security
Act (The Act).

56 Fed. Reg. 48,827.
72

These regulations went one step further than their
predecessor, however, and actually eliminated the
designations of Level A and Level B. The preamble notes
this change:

Comment: A number of commentors, especially those
dealing with resident activities and social
services, objected to the Level A and Level B
designations used in the organization of these
requirements. Their principal objection centered
around a belief that Level B requirements were less
important than Level A requirements.

Response: In order to prevent any further confusion
over this issue, we have decided to delete from part
483 all references to Level A and Level B
requirements.

id.”

Finally, as I discussed earlier, in 1992, HCFA published
another set of proposed regulations, which specified the
process for surveying SNFs under Medicare and NFs under
Medicaid and for certifying that these facilities meet
federal requirements for participation in Medicare and
Medicaid. 57 Fed. Reg. 39278 (1992). With regard to the
conditions of participation that must be met by
prospective providers, the preamble for the 1992 proposed
regulations stated:

Specifically, we note that the Act, at sections
1819(a) and 1919(a), defines a skilled nursing
facility and nursing facility, respectively, as one
which "* * * meets the requirements * * * described
in subsections (b), (c), and (da) of this section."
Similarly, the enforcement sections of the Act, at
sections 1819(h) and 1919(h), speak clearly to the
need for remedial action if a facility fails to meet
"a" requirement or "any" requirement set forth in
the Act.

2 The preamble went on to say that "[{i]t is

therefore necessary from an administrative standpoint to
continue to use the Level A and Level B designations for
all surveys until a new enforcement system and
accompanying forms and procedures are in place." 56 Fed.
Reg. 48,827-48,828. The preamble further stated that
remaining references to Level A and Level B would be
removed in the OBRA '87 enforcement regulation to be
issued later. 56 Fed. Reg. 48,828.
73

We realize that this approach would be a marked
contrast from the current system in which facilities
may be approved for program participation with level
B deficiencies as long as all level A requirements
are met. Congress, however, has removed this
flexibility from the survey and certification system
by admonishing the Secretary for having used a
hierarchy of Federal requirements (as are
represented by condition, standard, and element
levels) and by removing the concept of
"substantiality" from determinations of compliance.
What will be in place under sections 1819 and 1919
is a "horizontal" system of requirements which
obliges nursing home providers to comply with all
such requirements, not just a portion of them.

We are fully cognizant that this approach to
provider certification is a stringent one, but one
that we believe reflects the plain language of the
Act that Congress expects us to execute.

57 Fed. Reg. 39,282.

Again, HCFA reiterated its commitment to enforcing all
requirements for program participation, not just ones
that rise to a certain threshold level. Throughout the
process of promulgating regulations, HCFA has
consistently interpreted OBRA '87 as requiring compliance
with all regulatory requirements. Furthermore, as the
quoted preamble language makes clear, any deficiency with
regard to any regulatory requirement can be sufficient
basis to deny certification to a facility.

The preamble language emphasizes that enforcement will
not proceed on a hierarchical or two-tiered basis.
Instead, SNFs must be in compliance with every regulatory
requirement, and a deficiency with regard to any
regulatory requirement can provide sufficient basis to
deny certification. There simply no longer exists any
distinction between Level A and Level B requirements
because every violation is considered to be potentially
sufficient to deny certification.

Accordingly, the plain meaning, applicable case law and
the Federal Register preamble text cited above provide
overwhelming support for HCFA's position that the phrase
"all other requirements" contained at 42 C.F.R. § 489.13
means that SNFs not only must meet all requirements
established by regulation, but that any violation of the
regulatory requirements can provide a basis to deny
certification. Petitioner's contention that it can only
be denied certification if found deficient with respect
74

to Level A requirements or, alternatively, if found to
have Level B deficiencies which are of sufficient number
or type to constitute non-compliance with a Level A
requirement, is without merit. Any deficiency can form
the basis to deny certification.

VIII. Issue:

Whether failure to meet the 10-day requirement
contained in 42 C.F.R. § 488.110(j) can be used
to alter the requirements of 42 C.F.R. §
489.13.

Petitioner takes several stances regarding the date on
which it claims HCFA should have certified its facility.
Initially, Petitioner contends that it should be
certified effective December 23, 1993, because that was
the date that HCFA completed the survey of Petitioner and
conducted the exit conference. P. Br. at 1-2. In sum,
there is no evidence that Petitioner met all federal
requirements by the completion date of the survey;
therefore, its certification can only be the earlier of
the date on which it met all requirements or the date
when it submitted an acceptable plan of correction or
approvable waiver request to HCFA.*% 42 C.F.R. § 489.13.

Secondly, Petitioner contends that it should be certified
effective January 12, 1994. P. Br. at 9, 21. As support
for its position, Petitioner cites the regulation found
at 42 C.F.R. § 488.110(j) which directs surveyors to "In
accordance with your Agency's policy, present the
Statement of Deficiencies, form HCFA-2567, on site or
after supervisory review, no later than 10 calendar days
following the survey." Ten calendar days from December
23, 1993 is January 2, 1994. Petitioner contends,
however, that HCFA did not have the HCFA 2567 ready until
January 22, 1994. P. Br. at 21.% Allowing for an extra
day for the fact that January 2, 1994 was a Sunday,

bal Petitioner never alleged that it had made a
waiver request nor does the record reflect that any
waiver was granted. Thus, this basis for altering the
effective date is not an issue in this proceeding. The
only issues that are relevant to the determination of the
effective date in this proceeding relate either to the
date the deficiencies were corrected or the date HCFA
accepted Petitioner's plan of correction.

% This conflicts with testimony from Mr. Murray,
who says that he picked up the HCFA 2567 from the DHS
office on January 19, 1994. Tr. 2189.
75

Petitioner contends that HCFA violated the regulation by
failing to provide Petitioner with the survey results
within 10 calendar days following the survey. Petitioner
avers that had HCFA provided it with the HCFA 2567 within
10 calendar days as directed by regulation, Petitioner
would have submitted a plan of correction on January 12,
1994,

Petitioner therefore contends that it was HCFA's delay in
providing it with the HCFA 2567 that prevented it from
submitting its plan of correction before January 31,
1994. Accordingly, Petitioner requests that I find that
it met the requirements of participation as of January
12, 1994, the date upon which it claims it would have
submitted its plan of correction had HCFA provided it
with HCFA 2567 within 10 days of the exit conference.

Admittedly, Petitioner did not get the HCFA 2567 until
January 19, or 22, 1994. I cannot speculate as to when
Petitioner would have submitted the plan of correction
had HCFA been able to provide Petitioner with the HCFA
2567 within the ten days after completion of the survey.

The regulation at 42 C.F.R. § 489.13 is clear on its
face. Once HCFA, via a survey, finds a facility has
deficiencies, that facility cannot be certified until it
meets all requirements or submits an acceptable plan of
correction (or an approvable waiver request), whichever
date is earlier. Where there has been no evidence
presented of correction of the deficiencies, Petitioner
can be certified only upon submission of an acceptable
plan of correction. 42 C.F.R. § 489.13; SRA, Inc., DAB

CR341, at 5; Transitional Hospitals Corp., DAB CR350, at
8.

Moreover, although Petitioner's arguments may be based on
fundamental fairness, I do not have the authority to
equitably split the difference or fashion a remedy based
on HCFA's non-compliance with the 10-day requirement.
More importantly, I do not have the authority to find the
regulations ultra vires the Act, which is what I would
have to do in order to grant Petitioner the relief it
seeks.

As an essential and necessary step toward granting
Petitioner the relief it is seeking, I would first have
to ignore the explicit directive of the regulations,
which states that, absent evidence of correction of the
deficiencies, Petitioner can be certified only upon
HCFA's receipt of an acceptable plan of correction. 42
C.F.R. § 489.13(b)(2). My authority to hear and decide
76

this case simply does not give me the leeway to ignore
regulatory provisions.

Moreover, the provision that, according to Petitioner,
mandates to HCFA to provide the facility with HCFA 2567
within 10 calendar days is phrased in terms of the
agency's policy. 42 C.F.R. § 488.110(j). The provision
contains the words "in accordance with your agency's
policy." Neither 42 C.F.R. § 488.110(j) nor any other
provision in this section contains any penalty provision
for the agency's failure to comply with this 10-day
requirement. Additionally, as I stated in section IV. of
this decision, Subpart C of 42 C.F.R. Part 488, of which
42 C.F.R. § 488.110(j) is a subsection, has been rendered
inoperative by the nursing home reform provisions of OBRA
‘87. As I have already noted, not only does the legal
underpinning for Subpart C no longer exist, but Subpart C
is inconsistent with the OBRA '87 provisions and, indeed,
has been replaced by new survey protocols implemented by
HCFA to carry out the congressional mandate of OBRA '87.

These factors, coupled with the mandates contained at 42
C.F.R. § 489.13, favor an interpretation of the alleged
10-day "requirement" as a goal which HCFA should strive
to meet in all cases, but not as something which should
either invalidate the survey or mandate that HCFA grant
the SNF an earlier certification date than it was given,
in cases where this goal is not met. In short, there is
no provision in 42 C.F.R. § 489.13 to respond to
situations where HCFA delays transmittal of the form 2567
to a SNF.

Petitioner would have me act in such a way as to void a
regulation that is still in effect in favor of a
provision that is contained in a subpart which has been
rendered inoperative by law and which, by its very
language, is merely a guideline. JI am unable to do so,
and accordingly, find that the 10-day "requirement"
contained in 42 C.F.R. § 488.110(j) is not controlling
here. To find otherwise would be contrary to the
regulations and would also be outside of my delegated
authority.

Ix. Issue:

Whether the surveyors' use of a case-mix
stratified sample was in accordance with the
law.

Petitioner argues that the surveyors were required to use
the selection methodology described in 42 C.F.R. §
488.110(d) in selecting the resident sample to be
77

reviewed. P. Br. at 10. Petitioner contends that the
surveyors did not select the residents in a random manner
nor did they comply with the other requirements of this
regulation. Id. at 8, 10-11.

HCFA argues that the Act, as amended by OBRA '87,
requires surveyors to use a "case-mix stratified sample"
of residents. 42 U.S.C. §§ 1395i-3(g) (2) (A) (ii) and
1396r(g) (2) (A) (ii). HCFA Rep. Br. at 34. HCFA contends
that, as a result of implementation of the OBRA '87
requirements, this sampling methodology superseded the
random sampling approach described in Subpart C and is
thus the correct one to be used. Id.

The OBRA '87 requirement concerning resident sampling,
which is codified at 42 U.S.C. §§ 1395i-3(g) (2) (A) (ii)
and 1396r(g) (2) (A) (ii), states, "Each standard survey
shall include, for a case-mix st ified sample of
residents ... ." (emphasis added). The term "case-mix
stratified sample" is not defined. However, I have
examined SOM 250 and found that it contains detailed
instructions and guidance to enable surveyors to carry

out "case-mix stratified sampling". HCFA Ex. 13 at P-9 -
P-12. The SOM 250, in a section titled "Task 4 -
Resident Sampling", states: "The general objective is to

select a case mix stratified sample of residents for the
Standard Survey to conduct Individual Resident Rights,
Quality of Care, Environmental Quality and Dining
Assessments." HCFA Ex. 13 at P-9. The SOM 250, under a
subheading titled "Case-mix Categories", lists four case-
mix categories, and gives a description of the type of
resident who would fall in each category. Id. The four
categories are the following: case-mix group A -- "Light
Care" residents; case-mix group B -- "Heavy Care"

residents; case-mix group C -- "Non-interviewable light
care"; and case-mix group D -- "Non-interviewable heavy
care". The SOM 250 gives surveyors guidance in how to

select the resident sample and lists various factors to
be considered in the selection process, such as residents
with physical restraints, special resident care needs,
residents with complex or multifaceted problems requiring

2% Petitioner appeared also to make a
contradictory argument that the OBRA '87 requirement that
each survey include a "case-mix stratified sample of
residents" does not change any requirement of Subpart Cc.
P. Resp. Br. at 3. It is noteworthy that, with this
particular contention, Petitioner appears to concede that
the proper sampling methodology is case-mix stratified
sampling, which was what was employed by the surveyors in
this case.
78

interdisciplinary interventions, and residents with
psychosocial, interactive, and/or behavioral dysfunction.
Id. at P-10. To determine the minimum sample size, SOM
250 refers the surveyors to a table. HCFA Ex. 13 at P-9,
P-11.

As I stated earlier, 42 C.F.R. § 488.110(d) ("Task 2 --
Resident Sample -- Selection Methodology") refers to a
random sample. Specifically, this subsection states:

This methodology is aimed at formulating a
sample that reflects the actual distribution of
care needs/treatments in the facility
population. Primarily performed on a random
basis, it also ensures representation in the
sample of certain care needs and treatments
that are assessed during the survey. ...
After determining the appropriate sample size,
select residents for the sample in a random
manner. (emphasis added).

This section on resident sampling ends with the following
statement: "Always keep in mind that neither the random
selection approach nor the review of residents within the
specified care categories precludes investigation of
other resident care situations that you believe might
pose a serious threat to a resident's health or safety.
Add to the sample, as appropriate." 42 C.F.R. §
488.110(d).

As I previously stated, Subpart C, which describes random
sampling, does not conform to the case-mix stratified
sampling requirement of OBRA '87 (and codified at 42
U.S.C. §§ 1395i-3(g) (2) (A) (ii) and 1396r(g) (2) (A) (ii)).

I find that the implementation of OBRA '87 ushered in a
new selection methodology and resulted in the demise of
the approach provided for in 42 C.F.R. § 488.110(d). The
appropriate and correct methodology to be used, since the
enactment of OBRA '87, is the case-mix sampling approach,
which is elaborated upon in SOM 250.

Congress, by expressly referring to case-mix stratified
sampling in OBRA '87, intended that this methodology be
used by surveyors once OBRA '87 became effective. In the
legislative history of OBRA, the congressional committee
states, "The surveyors should be allowed to spend as much
time as they deem necessary to properly survey a
statistically significant case-mix stratified sample of
residents to determine compliance with the requirements
contained in this bill." H.R. Rep. No. 391, 100th Cong.,
ist Sess., pt. 2, at 939 (1987).
79

Based on the testimony of HCFA's witnesses, there appears
to be no dispute that the surveyors in this case followed
the instructions contained in SOM 250 in determining the
resident sample and, thus, used a case-mix stratified
resident sample. Nelson Ford, a health facilities
evaluator supervisor employed by the DHS, testified that
the surveyors followed the resident sample selection
table in SOM 250. Tr. 1648-1650. When asked how to
proceed when a provision in SOM 250 conflicts with the
applicable regulation, he testified that "[they] follow
the SOM 250." Tr. 1662. Mr. Ford stated that there did
exist "a rule that tells you how to sample or the number
in which -- of those patients falling within those
categories", and that this instruction is set forth in
SOM 250. Tr. 1670.

Another witness, Ruth Patience, who is a HCFA survey and
certification review specialist, testified that SOM 250
gives instructions on the subject of sampling and that
the sampling methodology described beginning on page P-9
of SOM 250 "is the methodology that we expect the state
agency surveyors to use when choosing their resident
sample". Tr. 2450, 2456. Ms. Patience stated that this
methodology was in effect in December 1993. Tr. 2456.

I find that the surveyors' use of a case-mix stratified
sample was in accordance with the law. The surveyors'
adherence to the sampling instructions and guidance
contained in SOM 250, which amplified the case-mix
sampling methodology required by the Act, was neither
improper nor irregular. Their course of conduct did not
violate any rights of Petitioner.

X. Issue:
Whether any of the following alleged

deficiencies as set forth in the HCFA 2567 were
proven.

The SOM 250 defines deficiency for the purposes of
determining whether Petitioner was in compliance with the
standards for participation as a Medicare provider.
Petitioner contends that the definition of what
constitutes a deficiency, i.e., what is the threshold for
determining whether a deficiency exists, differs
depending upon whether 42 C.F.R. § 488.110 or SOM 250 is
controlling. I have determined that the provisions of
SOM 250 are the applicable criteria to follow in
determining whether a deficiency has been established.

In accordance with that finding, it will be useful to
review such guidelines before I analyze each of the
80

deficiencies cited by the surveyors in the HCFA 2567
pertaining to Petitioner.

The SOM 250 contains the following definition:

. .. D. Criteria.--To determine if a level B
deficiency exists, use the following definitions:

o A "deficiency" is noncompliance with a
regulatory requirement. A deficiency may be
cited if there are situations identified during
the course of a survey of sufficient severity
and/or frequency that indicate an individual
requirement is not met.

o "Frequency" means the incidence or extent of
the occurrence of an identified situation in
the facility. The situation can affect a
single resident or several residents.

o "Severity" means the seriousness of the
identified situation (e.g., the degree to which
the problem compromises the resident's health
and safety, or fails to achieve the highest
practicable level of physical, mental, and
psychosocial well-being) .

For all requirements, the threshold at which
the frequency or severity of occurrences
amounts to a deficiency varies from situation
to situation. One occurrence directly related
to a life-threatening or fatal outcome or high
potential for such an outcome may be cited as a
deficiency including a determination of
immediate and serious threat.

HCFA Ex. 13 at P-29.

The SOM 250 provides additional guidance as follows:
The following three sections contain guidance on
using the information gained concerning

Environmental Quality, Dining, Quality of Care
Assessment, and Residents Rights Assessment.
81
E. Decisions Concerning Environmental Quality and

Dining.-- When making decisions regarding compliance
with those requirements reviewed during the EQA and
dining observation, use the following guidelines:

o Review all worksheets and documentation or
"B" and "C" ratings. Consider the actual
circumstances, i.e., your observations and
interview information, that caused each "B" and
"Cc" rating.

o Make your compliance decisions based on the
frequency or severity of the combination of
ratings for each tag number. For example, for
a specific tag, there may be 15 observations,
with 11 "A" ratings, 3 "B" ratings and 1 "Cc"
rating. Do not determine that a deficiency
exists solely because there was 1 "C" rating or
four negative ratings. Rather, make your
determination based on the documented
circumstances that represent the frequency or
severity necessary to substantiate non-
compliance.

F. Decisions Concerning Quality of Care Assessment.-
-Again consider your observations in the context of
frequency and severity. In determining the severity
of a situation, consider negative resident outcomes,
i.e., the impact of the facility's deficient
practice on the resident.

For all sampled residents, a negative resident
outcome which you determine was avoidable, i.e., due
to the facility's actions or lack of action, and not
due to the resident's clinical condition, or
exercise of his or her rights, provides strong
evidence of noncompliance. Negative outcomes
related to quality of care generally fall into three
categories:

o Physical, mental or psychosocial
deterioration (e.g., development of, or
worsening of, a pressure sore, insertion of an
indwelling catheter when the resident was
admitted to the facility without one, loss of
dignity lying in a urine saturated bed for a
prolonged period, social isolation caused when
staff fail to assist the resident to
participate in scheduled activities).
82

o Lack of reaching the highest practicable
level of physical, mental or psychosocial well-
being. No deterioration occurred, but the
facility failed to provide necessary care for
resident improvement. For example:

- The facility identified the
resident's desire to reach a higher
level of ability, e.g., improvement
in ambulation, and care was planned
accordingly. However, the facility
failed to implement, or failed to
consistently implement, the plan of
care, and the resident failed to
improve, i.e., did not reach
his/her highest practicable well-
being;

- The facility identified a
problem/need in the comprehensive
assessment, e.g., the resident was
withdrawn/depressed, but did not
care plan for it or prioritize it
to address it at a later time. The
resident received no care or
treatment to address the
problem/need and did not improve,
i.e., remained withdrawn/depressed.
Therefore, the resident was not
given the opportunity to reach
his/her highest practicable well-
being; or

- The facility failed to identify
the resident's need/problem/ability
to improve, e.g., the ability to
eat independently if given
assistive devices, and therefore,
did not care plan. As a result,
the resident failed to reach
his/her highest practicable well-
being, i.e., eat independently.

o A strong potential for harm. This may be
identified when an observed facility practice
is so divergent from accepted principles of
practice that a future negative outcome or harm
is probable. For example, nurse aides ina
facility often do not wash their hands between
caring for residents, including those times
that they change a bed soiled with feces.
Although there has been no evidence of a high
83

facility infection rate, or of spread of
infection from one resident to another, if a
resident contracts an infection or becomes
colonized with a highly contagious bacteria,
there is a high potential for a major outbreak
of nosocomial infection.

HCFA Ex. 13 at P-29 - P-30.

As shown above, SOM 250 directs the surveyor to analyze
the frequency and severity of noncompliance with
regulatory requirements and to make determinations as to
whether the facility is in compliance with an individual
requirement by assessing the frequency or severity of the
alleged violation.

Specifically, SOM 250 directs the surveyor to take into
account negative resident outcomes. It provides
flexibility in guiding surveyors in what constitutes a
deficiency and acknowledges that a deficiency is a very
situation specific occurrence. In short, a deficiency
can occur when there is evidence of noncompliance with a
regulatory requirement in 42 C.F.R. § 483, and the
noncompliance has a serious negative impact on the
resident or residents, such as harm or a strong potential
for harm. Examples of negative outcomes include
situations where the resident's health and safety has
been compromised, or where the facility failed to enable
the resident to achieve his or her highest practicable
level of physical, mental or psychosocial well-being.

A. Issue: Whether HCFA provided adequate notice to
Petitioner of the underlying facts of the deficiencies
cited in the HCFA 2567.

At various times throughout the hearing and in its
briefs, Petitioner contended that HCFA had taken a
“moving target/shell game" approach in presenting its
case. P. Br. at 44-45, 79; see P. Resp. Br. at 21. For
example, with respect to F 272, Petitioner complained of
the "vague, uncertain and inappropriate nature [sic]
manner in which this deficiency was set forth." P. Br.
at 44-45. Petitioner stated further:

It is not possible to defend against claims of
which petitioner had no notice and when such
claims are disclosed, then become subject to
repeated changes. Petitioner repeatly [sic]
referred to this approach as a "shell game."
The Administrative Law Judge repeatedly
rejected the accusation. Whatever the label,
it is not fair to. require petitioner to have to
84

guess at what it is supposed to be defending
against. This, by itself, disqualifies this
deficiency as part of any basis for failure to
certify.

P. Br. at 45.

I do not agree with Petitioner's characterization that
HCFA took a "moving target/shell game" approach. The
HCFA 2567 sets forth the alleged deficiencies which were
identified by the surveyors during the survey. The
surveyors testified concerning the underlying facts
supporting the deficiencies cited in the HCFA 2567. In
instances where a surveyor's testimony with respect to a
particular deficiency was unclear or confusing, I
ascribed as much weight to that testimony as was
appropriate. I did not consider allegations in the HCFA
2567 against which Petitioner could not adequately defend
due to a lack of specificity or notice. Further, in
instances where HCFA did not prove a certain allegation,
I have so indicated.

B. Set out below, in relevant part, is the statement in
the HCFA 2567 concerning the alleged deficiency
identified as F 221 (HCFA Ex. 2 at 1-2):

42 C.F.R. 483.13 (a) (a) Restraints. The
resident has the right to be free from any
physical or chemical restraints imposed for
purposes of discipline or convenience, and not
required to treat the resident's medical
symptoms [.]

RKEKK

Based on record review and observation[,] the
facility failed to provide each resident the
right to be free from physical restraint.

Findings include:

Resident 16 was assessed by licensed staff as
wandering and attempting to climb out of bed.
A vest restraint was ordered 5/13/93, and
continues to be used, restricting her to a
wheelchair during the day. Her ability to
ambulate has declined and the facility has
failed to adequately assess use of less
restrictive restraints, or the possibility of
discontinuation of the restraint, if staff was
more focused toward maintaining or improving
her independence in ambulation.
85

Resident 16 was admitted to Petitioner's facility on May
1, 1993. P. Ex. 1 at 1. A physician's order dated May
12, 1993, mandates the use of a vest restraint on
Resident 16 at all times for safety and proper body
alignment. P. Ex. 1 at 3. The 90-day and 180-day
assessments show that the order for Resident 16 to be
restrained in a vest restraint was in place through the
time HCFA completed its survey of Petitioner on December
23, 1993, over seven months after the physician's initial
order. P. Ex. 1 at 1-4; P. Ex. 27 at 1-7.”

At the hearing, Ms. Cox testified that she saw Resident
16 on more than one occasion during the survey and that,
each time, the resident was confined in a vest. Tr.
1003-1004, 1023. Ms. Cox testified that she found no
evidence that Resident 16 had ever been considered for a
less restrictive restraint other than a vest because
there was nothing in the resident's record to indicate
that Resident 16 was ever assessed at any time to
determine if some lesser restraint could be used, or if
any restraint were necessary. Tr. 2463-2464.

The rehabilitation screen supports HCFA's position
because the screen has a specific line for stating the
reasons for using any physical restraint. P. Ex. 1 at 4.
The line on Resident 16's rehabilitation screen is blank.
P. Ex. 1 at 4. According to HCFA, reevaluation of the
use of a restraint is critical to the health and well-
being of patients because "[a)nytime a person is
immobilized it's going to decrease their strength and
their ability to walk and use their muscles .. . they're
going to get weaker." Tr. 1020.

” Although factual allegations regarding whether
Resident 16 was properly ambulated and whether her
ability to ambulate declined as a result of Petitioner
placing her in a vest restraint appear also on the HCFA
2567 with respect to F 221, they are not relevant to the
issue of whether Petitioner adequately assessed Resident
16 for a less restrictive restraint as required by 42
C.F.R. § 483.13(a) and F 221. They are relevant in
assessing whether a negative or potentially negative
outcome resulted from this deficiency. I address the
factual allegations concerning resident 16's ambulation
in the context of my discussion of F 309 (section X.L. of
this decision).
86

In support of HCFA's contention that the resident should
be reassessed periodically to determine whether a less
restrictive alternative would be feasible, Ms. Patience
testified that it is important that

the restraint not be used for discipline or
convenience. We survey for that by looking for
whether or not less restrictive measures were used
before the restraint was applied and whether or not
there was an assessment . . . Less restrictive means
that the facility has tried other methods ... .

Tr. 2464.

At issue in this deficiency is whether Petitioner
violated the requirement at 42 C.F.R. §483.13(a) (F 221)
by failing to adequately assess Resident 16 for the use
of less restrictive restraints. SOM 250 provides
specific guidance for SNFs regarding the need for
documenting that the facility has considered less
restrictive alternatives to restraints:

When coupled with appropriate exercise, therapeutic
interventions such as pillows, pads, or removable
lap trays, are often effective in achieving proper
body position, balance and alignment, and preventing
contractures without use of restraints. Attention
to individual, mental, physical and psychosocial
needs, meaningful activity, environmental changes,
and aggressive nursing rehabilitation or restorative
programs are other examples of less restrictive
methods of meeting resident needs. If the restraint
is used to enable the resident to attain or maintain
his or her highest practicable level of functioning,
a facility must have evidence of consultation with
appropriate health professionals, such as
occupational or physical therapists. This
consultation should consider the use of less
restrictive therapeutic intervention prior to using
restraints. . .

The use of therapeutic interventions must be
justified through the care planning process and
demonstrate that these interventions promote the
care and services necessary for the resident to
attain or maintain the highest practicable well-
being. ...

The decision to apply physical restraints should be
based on the assessment of each resident's
capabilities, an evaluation of less restrictive
alternatives and the ruling out of their use. The
87

plan of care should also contain a schedule or plan
of rehabilitative training to enable the progressive
removal of restraints or the progressive use of less
restrictive means, as appropriate. This systematic
approach assures that restraints would not be
applied for purposes of discipline or convenience
and only to enable treatment of medical symptoms.

HCFA Ex. 13 at P-76 - P-77.

Ms. Patience stated that any resident who was being
subjected to a vest restraint should have, in his or her
medical record, evidence showing that less restrictive
restraints had been considered. Tr. 2485-2486. Ms.
Patience testified further that such evidence might be
documented in the therapy notes, nurses' notes,
physicians' notes, or social services notes. Tr. 2486.
According to Ms. Patience, in light of SOM 250, such
evidence would need to demonstrate

an assessment of the resident's mobility, cognition,
vision, and any other less restrictive measures that
were used; how long they were used for; and what the
results of the use of those less restrictive
measures were.

Tr. 2487.

I find credible the testimony of Ms. Patience which
indicates that there should be documentation in the
record to reflect that less restrictive alternatives to a
vest restraint were attempted or at the very least,
considered for this resident. Tr. 2486-2487. Her
testimony is supported by the plain meaning of the
regulation and the guidance contained in SOM 250, as
noted above.

However, Petitioner attempts to attack HCFA's finding of
deficiency by contending that there is no evidence that
resident 16 spent all of her time in a vest restraint in
a wheelchair, since the surveyor was not present at all
times. Additionally, Petitioner contends that medical
records establish that Resident 16 was not constantly
restrained in a vest restraint. P. Br. at 24-25. These
contentions are not germane to the issue at hand, because
the issue with regard to this deficiency is whether
Petitioner ever considered resident 16 for less
restrictive alternatives to the vest restraint, not
whether resident 16 was under restraint at all times.
88

Petitioner contends also that the evidence does not lend
support to HCFA's finding that Petitioner was deficient
with regard to F 221 because resident 16's chart reflects
that: 1) a physician ordered the use of the vest
restraint for Resident 16 and repeated the order every 30
days; 2) the staff recommended to the physician that
resident 16 wear a safety belt-at all times; 3) the
interdisciplinary team agreed with the use of the vest
restraint at all times; and 4) the continued use of the
vest restraint was considered on a quarterly basis. P.
Br. at 25.

This dispute, simply stated, is whether Petitioner is
required to document that a less restrictive restraint
was considered for resident 16. Petitioner argues that
there exists no regulation or other requirement to compel
Petitioner to document why a lesser or different
restraint should not be used when a physician has
explicitly ordered a specific type of restraint for a
resident. P. Br. at 25.

Petitioner contends that, to the extent it is required to
examine why resident 16 continued to need a vest
restraint, such examination was undertaken by the
interdisciplinary team. P. Br. at 29. Moreover,
Petitioner contends that neither SOM 250 nor the
regulation can be read to require the substance of the
subjects discussed by the interdisciplinary team to be
set out in writing. According to Petitioner, the fact
that the interdisciplinary team approved the use of the
restraint is sufficient to satisfy the regulatory
requirements. P. Br. at 31. Distilled to its essence,
Petitioner's argument on this issue is that the
repetition of a physician's order and the repeated
approval of the interdisciplinary team suffice.

Petitioner's arguments on this issue are not supported by
the record because the record contains nothing which
would indicate that the interdisciplinary team ever
considered less restrictive alternatives. While there is
a repeated note from the interdisciplinary team to use a
vest restraint on resident 16, there is nothing in the
record to establish that this was anything more than an
approval of what had been done before. P. Ex. 1; P. Ex.
27 at 6, 22. Even assuming arguendo that it was
medically appropriate to treat resident 16 by placing her
in a vest restraint at all times, the issue remains
whether Petitioner satisfies the statutory and regulatory
mandate that the resident has a right to be free from
restraint. The statutory and regulatory framework, the
language of the regulation, and the guidance contained in
SOM 250 all support that it is incumbent upon Petitioner
89

to document that the restraint was necessary for the
patient's medical or safety needs. These same factors
further mandate that it is also incumbent upon Petitioner
to show that less restrictive alternatives were attempted
or at least considered.

Without such information, Petitioner did not prove that
it ever considered less restrictive alternatives for
resident 16 because the evidence HCFA has offered is
persuasive, credible, and unrebutted. I find that
Petitioner's reliance on the mere repetition of an order
that resident 16 be restrained is insufficient, given the
requirements of OBRA '87 and SOM 250.

I find that HCFA has proven that Petitioner was in
violation of the regulatory requirement set forth at 42
C.F.R. § 483.13(a) with respect to resident 16. The
regulations require more from Petitioner than merely a
repeated order that the resident be restrained. While
there are notations that indicate that resident 16 was
initially placed in a restraint for reasons of safety and
proper body alignment, there is nothing in the record
from which I can conclude that Petitioner ever considered
the resident for a less restrictive restraint. P. Ex. 1
at 2, 22; P. Ex. 27.

Ensuring that residents are restrained only to the extent
absolutely necessary for their medical well-being or
safety was of paramount concern to the authors of the law
and the regulations. H.R. Rep. No. 391, 100th Cong., ist
Sess., part 1, at 932 (1987). They expressed a
legitimate concern that restraints were being used merely
for the convenience of the facility and in ways that were
detrimental to the residents. The regulations mirror
this concern.

It is this interest and concern of Congress that places a
duty on Petitioner to justify the use of a particular
type of restraint on resident 16 and to demonstrate that
a less restrictive alternative was considered and found
inappropriate in light of this resident's condition. It
was incumbent upon Petitioner to document that its
decision to continually restrain resident 16 in a vest
restraint was not a mere rubber stamp, but a decision
that actually considered less restrictive alternatives.
The record in this case fails to establish not only that
less restrictive restraints were used on resident 16, but
that less restrictive restraints were even considered for
resident 16.
90

Moreover, based on the evidence of record and applying
the SOM 250 guidelines, I conclude that, without adequate
documentation that other less restrictive alternatives
were not available, placement of resident 16 in a vest
restraint could result in a potential negative outcome.
Accordingly, I find that the record more than adequately
supports that Petitioner was in violation of the
regulatory requirement set forth at 42 C.F.R. § 483.13
with respect to resident 16.

c. Set out below is the statement in the HCFA 2567

concerning the alleged deficiency identified as F 262
t 2-3):

42 C.F.R. 483.15(h) (3) (3) Clean bed and bath
linens that are in good condition;

KKEKK

Based upon observation of residents rooms it
was determined that furniture was in need of
cleaning.

Findings include:

During tour of the facility, interviews, and
room visits, it was noted that overbed tables
and bedside cabinet tops had food and liquids
[sic] rings indicating a lack of daily cleaning
of the room furniture.

At the hearing, Ms. Shekell testified that an inadvertent
typographical error occurred in the HCFA 2567 when the
she apparently mistyped "F 262" on her lap-top computer
instead of "F 261." The computer is programmed by HCFA
to automatically display the applicable regulatory
citation that corresponds to the "F" number entered.

Ms. Shekell testified that "262 addresses primarily
linens, whereas 261 is sanitary cleanliness." Tr. 116.
The corresponding regulatory citation for "F 261",
according to Ms. Shekell and the SOM 250, is 42 C.F.R. §
483.15(h)(2). Tr. 121; HCFA Ex. 13 at P-96 - P-97.

A reading of the pertinent regulations suggests that the
correct citation could have been either 42 C.F.R. §
483.15(h) (1), which states: "A safe, clean, comfortable,
and homelike environment, allowing the resident to use
his or her personal belongings to the extent possible" or
subsection (h) (2), which states: "Housekeeping and
maintenance services necessary to maintain a sanitary,
orderly, and comfortable interior." In my opinion,
91

subsection (h)(2) is the most appropriate subsection for
the deficiency cited.

Petitioner argues that, based on HCFA's failure to cite
the correct regulatory citation, it was not given
adequate and proper notice of the deficiency to enable it
to prepare a defense. It further argues that, due to
such failure, HCFA should be estopped from proving the
existence of this deficiency. Moreover, Petitioner
contends that the facts cited do not constitute a
violation of the regulation, and there is a failure of
proof of violation. Tr. 116-120; P. Br. at 33-35.

In response, HCFA states that the deficiency was
correctly cited in the HCFA 2567 and Petitioner has had
access to that document for over a year prior to the
hearing. In addition, HCFA asserts that Petitioner
addressed the cited deficiency when it submitted its plan
of correction. Tr. 118; HCFA Br. at 22.

When this issue was first raised at the hearing, I
expressed my concern that Petitioner's due process rights
be protected. I allowed testimony on the cited
deficiency with the admonition that I would rule on
Petitioner's arguments after reading the parties'
posthearing briefs. After fully considering the notice
issue, I conclude after examining HCFA 2567 that
Petitioner received adequate notice of the deficiency
even considering the incorrect reference to the
regulations. The applicable regulations are a matter of
public record and were available to Petitioner at the
time of the survey. To allow Petitioner to adequately
defend against this deficiency, HCFA 2567 needed to set
out the facts the surveyor found that supported her
determination that a deficiency was present. Petitioner
was presented with those facts. The cited regulation
clearly did not apply to the deficiency cited, and
Petitioner could easily have ascertained knowledge of the
correct regulation or regulations by making reference to
them. There is no evidence that Petitioner was incapable
of responding to this deficiency in its plan of
correction or at the hearing. Therefore, I conclude that
Petitioner's due process rights were not impaired by
HCFA's inadvertent reference to the wrong regulation when
citing this deficiency in the HCFA 2567.
92

Ms. Shekell testified that her observation of the cited
deficiency was based on her daily tour of Petitioner
while conducting the survey:

I noted that particularly over-bed tables were
not well cleaned; they had rings. And I would
never cite if there was just one or two that a
patient had just been fed or if fluid had just
been s(e]t down and rings from something like
that just on a few tables. This was pervasive
throughout room after room.

Tr. 122.

Petitioner objected to this testimony because it
allegedly went beyond the parameters of the cited
deficiency when Ms. Shekell testified that the deficiency
was "pervasive" throughout the facility. Petitioner's
counsel argued that HCFA should be limited to the
allegations specifically written in the HCFA 2567. Tr.
123-126. As to the observations of Ms. Shekell,
Petitioner responds that "(t]here was no testimony as to
how many days she was in the facility, how often she
observed the tables, any investigation as to how long the
liquid rings on the over[(-]bed tables had been there, any
facts to indicate that they had been there an inordinate
length of time to indicate a lack of cleaning or any
facts other than . . . self-serving speculation... ."
P. Br. at 34. In contrast, Petitioner pointed out that
Ms. Downing testified that the facility was cleaned daily
and over-bed tables were cleaned after each meal if the
resident ate in bed and spilled his or her meal.
Petitioner argued further support for Ms. Downing's
testimony could be found in Petitioner's Housekeeping
Department policies. P. Br. at 34; Tr. 1750-1751; P. Ex.
2 ati.

I find unpersuasive Petitioner's argument that Ms.
Shekell's testimony went beyond the deficiency cited.
With respect to this deficiency, the HCFA 2567 indicates
that "(b]Jased upon observation of residents rooms it was
determined that furniture was in need of cleaning." HCFA
Ex. 2 at 2. Moreover, the surveyor noted the unclean
surroundings "(d]uring tour of the facility, interviews,
and room visits." Id. Thus, the HCFA 2567 on its face
indicates that the observation was not based on an
isolated observation but on a pattern of sightings that
occurred during Ms. Shekell's inspection of the facility.
This is consistent with her testimony. Petitioner's
counsel was advised at the hearing that he had the
opportunity through cross examination to test the
93

validity of Ms. Shekell's observations. This he chose
not to do.

Despite the testimony of Ms. Downing and reference to
housekeeping policies requiring daily cleaning of
resident rooms, including over-bed tables, Petitioner
offered no witness who was present during the survey who
specifically contradicted the observations of Ms.
Shekell. The only evidence offered was Ms. Downing's
testimony and the housekeeping policy. Such evidence is
not reliable or probative as to whether Ms. Shekell's
observations were accurate. Ms. Downing was not employed
by Petitioner at the time of the survey, nor was she
present during the survey. Nor is there any testimony
from anyone who was employed at the facility at the time
of the survey that the housekeeping polices were in fact
followed during the period of the survey. If it exists,
such evidence would have been available to Petitioner.
Its absence suggests that Petitioner cannot directly
contradict the findings of the State surveyor.

Therefore, when I review the record as a whole, the
testimony of Ms. Shekell concerning her findings
supporting this deficiency are amply supported and
establish the existence of the cited deficiency. Having
concluded that Petitioner has failed to maintain a
sanitary, orderly, and comfortable interior for its
residents, it follows that such non-compliance with the
regulatory requirements could potentially compromise such
residents' health and safety or at least compromise their
mental or psychosocial well-being. Residents have a
right to reside in a clean, safe and healthy environment.
Petitioner's conduct is in variance to this right imposed
by OBRA '87.

D. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 272
(HCFA _ Ex. 2 at 3-4):

42 C.F.R. 483.20(b) (1) (1) The facility must
make a comprehensive assessment of a resident's
needs, which --

(i) Is based on a uniform data set specified by
the Secretary and uses an instrument that is
specified by the State and approved by the
Secretary; and (ii) Describes the resident's
capability to perform daily life functions and
significant impairments in functional capacity.

94

(2) The comprehensive assessment must include
at least the following information:

REE

Based upon observation, interview and medical
record review[,] it was determined that
comprehensive assessments contained
inaccuracies of residents functional ability.

Findings include;

Inaccuracies were noted on 3 [o]f 5 medical
records reviewed of residents capacity to
perform daily life functions, i.e.; toileting,
incontinence, activities of daily living,
transfer, locomotion, personal hygiene, and
psycho-social functioning. Many of the
activities of daily living were contradictive
and did not reflect the residents admission or
current status.

For example, resident 12 was assessed to
require supervision with transfers, ambulate
and toilet independently but required
assistance with personal hygiene. Furthermore,
the psycho-social assessment indicated there
were no problems, however the resident is [sic]
in fact been seeing the psychologist weekly for
several months and receives Elavil 50 mg. ona
daily basis for depression.*

Petitioner argues that the only resident who was
identified as being the subject of the surveyor's
allegations was resident 12. P. Br. at 36, 38.
Petitioner contends that "[t]here was a complete failure
of proof concerning the allegations of inaccuracies (with
respect to resident 12) regarding transfers, ambulation,
and psychosocial assessment." Id. at 40. Petitioner
contends that Ms. Shekell's testimony was inconsistent
and that resident 12's MDS [minimum data set] "complied
with the regulations." Id. at 44. Petitioner states
also, among other things, that the testimony of Ms.
Patience suggests that F 272 was incorrectly cited, and

ca At the hearing, Ms. Shekell testified that she
was the surveyor who had written the specific allegations
under this regulation. Tr. 127.
95

that the proper citation should have been F 287. P. Br.
at 47, 118.”

As a preliminary matter, I must first address the issue
of which residents were identified to Petitioner as being
the basis of the allegations. Although the HCFA 2567
mentions that "3 of 5 medical records" were reviewed, I
find that this did not adequately identify the other
residents in addition to resident 12 who were the subject
of Ms. Shekell's findings such that Petitioner could have
a meaningful opportunity to respond to the allegations.
At the hearing, when asked if she recalled identifying
any specific patient records to Petitioner during the
survey or exit conference, Ms. Shekell testified, ". ..
we don't really discuss the specific patients during the
exit conference. However, during the survey process we
talk to the facility staff regarding individual patients
in which we find inconsistencies or problems." Tr. 154.
Ms. Shekell stated that she spoke to Petitioner's staff
about resident 12, but she could not recall whether she
spoke to them about the other patient records she alluded
to in her findings on the HCFA 2567. Tr. 155.

Thus, despite the fact that Ms. Shekell referred to other
patient records in HCFA 2567, the record of resident 12
is the only resident record against which Petitioner
could adequately prepare a defense with respect to F 272.
With respect to the other residents referred to in HCFA
2567, HCFA was unable to specifically identify them or
the records alleged to be deficient. HCFA did not prove
that Petitioner's treatment of other residents, in
addition to resident 12, violated 42 C.F.R. §
483.20(b)(1). Accordingly, I am deciding whether HCFA
has proven its claim that Petitioner was in violation of
section 483.20 (b)(1) (F 272) based only on my
consideration of the medical record of resident 12.”

29 In its discussion of F 272, Petitioner quotes
statements made by myself and by HCFA's counsel (Tr. 168,
164) at the hearing. P. Br. at 37-39. Petitioner
apparently means to illustrate that my statements and
those of HCFA's counsel were made in conjunction with the
testimony taken concerning F 272. However, an
examination of the transcript indicates that these
statements were made in conjunction with the testimony
concerning F 289, not F 272.

%© I do not hold that HCFA must identify in its
2567 each resident whose records were reviewed in
connection with a cited deficiency. However, the
(continued...)
96

Furthermore, Ms. Shekell testified on cross-examination
that the sentence "For example, resident 12 was assessed
to require supervision with transfers . . . personal
hygiene" which she wrote in the HCFA 2567 is not a
deficiency, but merely "a statement of fact." Tr. 323.
Ms. Shekell stated that the actual deficiency she is
alleging is described in the following sentence:
"Furthermore, the psycho-social assessment indicated
there were no problems, » «. » on a daily basis for
depression." Tr. 324.°! Ms. Shekell agreed with
Petitioner's characterization that her basis for finding
fault with resident 12's record "is that one part of it
seems to say that the patient didn't have any
psychosocial problems when in fact [she] believe[d] other
parts of the record indicate to the contrary." Tr. 324.

HCFA argues that "(w]Jith respect to resident 12, her mood
and behavior patterns (i.e. her mental and psychosocial
status) and her recurrent thoughts of death are not
accurately described on the underlying resident
assessment instrument approved by the Secretary (the MDS
and its quarterly reviews)." HCFA Resp. Br. at 14. HCFA
claims that resident 12's MDS is "inconsistent, both
internally and with the documentation contained in other
parts of the resident's chart." HCFA Resp. Br. at 12.
Simply stated, according to Ms. Patience, ". . . the
minimum data set didn't match what was going on with the
resident." Tr. 2681.

3 (...continued)
deficiency must provide sufficient information such that
Petitioner, exercising reasonable diligence, could
determine to whom the deficiency relates. Here the
deficiency failed to supply such information. Such
failure could be overcome where the evidence shows that
Petitioner received identifying information either in the
course of the survey process or through documentary
evidence submitted in preparation for the hearing.
Neither of these circumstances occurred in this case with
respect to this deficiency. Moreover, HCFA's principal
witness on this deficiency could not offer any testimony
or exhibits to support the allegations relating to the
other residents cited in the deficiency.

3 Ms. Patience testified that she did not see "a
psychosocial assessment per se" in P. Ex. 3. She stated
that she believed that the term "psycho-social
assessment" used in the HCFA 2567 is a reference to
section H of the MDS. Tr. 2685.
97

The MDS document is required to be completed for every
resident within the first 14 days after admission (42
C.F.R. § 483.20 (b) (4) (i); Tr. 136), and addresses 18
areas, including delirium, cognitive loss/dementia, ADL
{activities of daily living] functional/Rehabilitation
potential, urinary incontinence and indwelling catheter,
psychosocial well-being, mood state, behavior problems,
falls, nutritional status, dehydration/fluid maintenance,
pressure ulcers, and physical restraints. The SOM 250
states: "The information required in § 483.20(b) (2) (i -
xiii) is incorporated into the MDS, which forms the core
of each State's approved RAI [Resident Assessment
Instrument]." HCFA Ex. 13 at P-100. A facility assesses
a resident in each area by filling in boxes on the MDS
with either checks or numbers. A new MDS must be
initiated promptly after a resident experiences a
significant change in his physical or mental condition.
In no case can the MDS be done less than once every
twelve months. 42 C.F.R. § 483.20(b) (4) (iv)-(v); Tr.
138.

32 On the MDS document, below the title "Minimum
Data Set," is the phrase "For Nursing Facility Resident
Assessment and Care Screening (MDS)." P. Ex. 3 at 2.

3 There is evidence that the terms
"comprehensive assessment" and "MDS" are interchangeable.
Ms. Shekell testified:

The minimum data set is -- that's where they
get the word comprehensive assessment because
it goes through cognitive, communicative,
vision, hearing, skin care, ability of the
patient to take care of themself [sic],
psychosocial well being, health conditions,
their ability for activity levels, for
functioning levels, nutritional levels, their
potential for accidents, their skin problems,
et cetera. In other words, it's kind of
looking at the patient from head to toe.

Tr. 136.

Ms. Cox testified also that the MDS is the comprehensive
assessment. Tr. 1275.

4 Ms. Shekell testified that if a resident goes
to the hospital or is out of the facility for a short
period of time, the facility may still be able to refer

(continued...)
98

Depending on a particular response on the MDS, an
"automatic trigger" or "potential trigger" may be
indicated, and such triggers direct the staff to fill out
the corresponding category on another document called the
Resident Assessment Protocol Summary (RAPS).* The RAPS
lists the identical 18 areas found on the MDS (i.e.,
delirium, cognitive loss/dementia, visual function,
communication, ADL function/rehabilitation potential,
etc.). The facility is instructed to show, for each RAP
area triggered, whether it is proceeding with a care plan
intervention by checking either "proceed" or "not
proceed" next to the problem area that was triggered.

The facility is also to show where the appropriate
documentation (i.e., problems, complications, risk
factors, reasons for deciding to proceed or not to
proceed to care planning) can be found.

Resident 12's MDS was completed on July 30, 1993. P. Ex.
3 at 2. The relevant section of the MDS for purposes of
this deficiency is Section H, which has the heading "Mood
and Behavior Patterns". P. Ex. 3 at 3-4. In

4 (...continued)
back to the last MDS instead of doing another MDS. Tr.
at 671. However, if the resident's hospital admission
altered the patient's status, or the reason that the
resident was sent out of the facility was due to a change
of condition, then the facility would have to complete a
new MDS upon the resident's return to the facility. Tr.
at 672.

35 The SOM 250 states, “Additional assessment
information is also gathered using triggered RAPS." HCFA
Ex. 13 at P-100. Ms. Shekell testified that the
"identified problems must be transferred to th[e] RAPS,
and then this is the basis for forming a patient care
plan." Tr. 140. Ms. Shekell testified further that the
MDS and the RAPS have to correspond with each other and
contain the same information. Id.

36 The signatures section on the MDS indicates
which staff members participated in its completion, the
particular section(s) of the MDS each staff member
completed, and the date of completion. P. Ex. 3 at 2.

Although there is a signature of the staff person who
completed sections G & H of the MDS, the date of

(continued...)
99

subsection H.1 ("Sad or Anxious Mood"), Petitioner's
staff has checked off Boxes "a" and "e" to indicate that
the resident had exhibited "verbal expressions of
distress" and "pervasive concern with health" during the
last thirty days, i.e., June 30 - July 30, 1993. P.
Ex. 3 at 3. There were no checks in Boxes "b"-
"tearfulness, emotional groaning, sighing,
breathlessness"; "c"- "motor agitation such as pacing,
handwringing or picking"; "d"- "failure to eat or take
medications, withdrawal from self-care or leisure
activities"; "f£"- "recurrent thoughts of death and "g"-
suicidal thoughts/actions". The absence of checks
reflected these behaviors were not exhibited in the
covered period. In subsection H.2 ("Mood Persistence"),
Petitioner's staff filled in a "0" (i.e., zero) next to
the phrase "Sad or anxious mood intrudes on daily life
over last 7 days -- not easily altered, doesn't "cheer
up". P. Ex. 3 at 3. The zero represents that resident
12 had not experienced any sad or anxious mood during the
time frame of July 24-30, 1993. Also, in subsection H.6,
Petitioner's staff indicated that the resident had not
had a change in mood in the 90 days preceding. Id.

As discussed earlier, certain responses on the MDS will
set off "triggers" which direct the staff to fill out the
corresponding section on the RAPS. Then, based on the
information contained in the MDS and the RAPS, Petitioner
formulates an individualized care plan which will be
responsive to the resident's problems and needs. see Tr.
2504.

Here, with respect to resident 12, the presence of
"verbal expressions of distress" and "pervasive concern
with health", as indicated on the MDS, constitute

36 (...continued)
completion of these sections is missing. P. Ex. 3 at 2.

Thus, I am using July 30, 1993 as the completion date
because it is the latest completion date given and is
also the date when the RN Assessment Coordinator signed
the MDS.

37 I construe this section as requiring the
facility to check any of the eight specified indices of a
sad or anxious mood that occurred on any day during the
last 30 days where such behavior would significantly
impact on the resident's care in the facility.

Therefore, a single expression of a suicidal thought or
action would require the facility to note such expression
in the MDS.
100

"automatic triggers". I find that Petitioner filled out
the RAPS for these two problem areas which were triggered
(P. Ex. 3 at 6) and that the RAPS, with accompanying
notes, are consistent with the July 1993 MDS. P. Ex. 3
at 6, 9.

Resident 12's record contains also a care plan entry
dated September 1, 1993. Petitioner's staff wrote, under
"psychosocial needs", the following: "Resident chooses
not to leave her room except for dialysis 3x/wk & group
psychotherapy 1x/wk." P. Ex. 3 at 24. The "measurable
and time oriented objectives" stated that the "resident
will receive socialization from staff, family or other
residents QD x 3 months by 12/1/93." Id. The
“approaches/actions" to be taken included encouraging
family visits and participation, and group and individual
psychotherapy. Id. These care plan entries appear to
have been written in response to a Social Assessment
completed on September 1, 1993, on which a social worker
indicated that the resident was depressed due to illness
and separation from family, and was motivated to
progress. P. Ex. 3 at 21.

On September 13, 1993, a physician's order in resident
12's chart states that the resident "may attend
psychological meeting Q Wednesday". Also, a physician's
order dated September 14, 1993 states "psychology eval &
tx as indicated by psychologist." P. Ex. 3 at 10-11.

On September 15, 1993, the resident underwent a
diagnostic interview with a psychologist, and the
psychological diagnostic interview report states that the
resident had been referred due to "depressive Sx,
difficult adjustment to losses, and isolation". P. Ex. 3
at 15. In giving the mental status exam results and the
interview findings, the examining psychologist wrote that
she "appears to be experiencing major depression today,
speaking of being ready for death (suicide risk
minimal)({.] No signs of delusions/hallucinations.
Cooperative and desirous of pleasing examiner." Id.
Although the form contains a depression scale, this was
left blank. Id.

Based on this 9/15/93 psychological report, I find that
the resident showed an indication of a potentially
serious psychological problem. However, Petitioner did
not conduct a new MDS at this time and left the July 1993
MDS in place, unchanged. In doing so, Petitioner thus
inaccurately represented that the July 1993 MDS continued
to reflect the current condition of resident 12 although
it did not. As of September 15, 1993, based on the
psychological report, the assessment of the resident's
101

mood and behavior patterns as stated in the July 1993 MDS
was no longer accurate due to the resident's change in
her psychosocial status. The fact that the resident was
experiencing a level of depression which had not been
noted previously, as described by the psychologist,
constituted a significant change in her condition within
the meaning of SOM 250.

Ms. Patience testified:

If the resident is exhibiting a change then
there may be a new minimum data set indicated,
and that needs to be done if the resident's got
a significant change.

Tr. 2495.

When asked what type of mood change would necessitate a
change in the assessment, Ms. Patience responded:

If the resident's a little bit blue that might
not indicate that there needs to be a whole new
MDS. If the resident is depressed, definitely
there needs to be a new MDS done. Because the
depression can impact things like eating,
mobility, whether or not the resident wants to
interact with other residents; all of those can
be affected by depression.

Tr. 2496.

Ms. Patience stated also that resident 12's treatment by
a psychologist and the order for Elavil would constitute
a significant change in her condition. Tr. 2501; see Tr.
2497. She expressed her opinion that, with respect to
resident 12, she "would have expected a new minimum data
set sometime in September." Tr. 2501; see Tr. 2674.

Petitioner should have completed a new MDS after resident
12's psychological interview to reflect the change in her
psychosocial status. The completion of a new MDS would
have resulted in boxes "g" and "a" under section H.1.
being checked, indicating that the resident had "suicidal

38 According to SOM 250, an example of a
“significant change" would be "deterioration in behavior
or mood, to the point where daily problems arise or
relationships have become problematic and staff conclude
that these changes in the resident's psychosocial status
are not likely to improve without staff intervention."
HCFA Ex. 13 at P-104.
102

thoughts/actions," and exhibited "withdrawal from self-
care or leisure activities," respectively. P. Ex. 3 at
3. These boxes had not been checked off on the July 1993
MDS. In addition, the presence of these symptoms are
"automatic triggers", which would then have directed
Petitioner to fill out the RAPS for these specific areas.
This process did not occur.

The resident was provided weekly individual and/or group
psychotherapy by a psychologist starting September 15,
1993 through December 22, 1993.% P. Ex. 3 at 16 - 19.
The weekly entries suggest some improvement in her mental
state over this period of time. Id. A physician order
dated 10/12/93 in the resident's chart states "D/C
Restoril; Elavil 50 mg. HS [hour of sleep] (insomnia) ."
In her medication records, there is an entry dated
October 12, 1993 that states "Monitor episodes of
depression as evidenced by expressing wanting to die.
Hs. (Elavil). P. Ex. 3 at 12. Despite her serious
depression with suicidal ideation on September 15, 1993,
her medication was not changed or monitoring initiated
until October 12, 1993.*' Almost 30 days elapsed from
the time of the resident's 9/15/93 psychological

40

3 ~In the progress notes, the psychologist
indicated that one of the resident's treatment goals was
"Stabilization of depressed mood." P. Ex. 3 at 16-19.
For September 1993, the psychologist indicated that the
resident had moderately progressed toward achieving this
goal. In October 1993, the progress notes show that the
resident's progress toward stabilizing her depressed mood
was at about the same level as in September. Id. at 17.
In November 1993, the progress notes indicate that
resident 12 was continuing to make progress and was
benefitting from group dynamics. Id. at 18. In December
1993, the notes state that she was concerned with family
issues but her underlying mood was of "strength and
optimism." Id. at 19.

40 Elavil is an antidepressant. Tr. 142.

41 There is a care plan dated September 1, 1993 for
the resident's unwillingness to leave her room except for
dialysis and group therapy. P. Ex. 3 at 24. The
approaches/actions stated relate to encouraging increased
socialization and initiating group and individual
psychotherapy. Id. It was during the diagnostic
interview by the psychologist on September 15, 1993 that
her suicidal ideation and major depression was noted. P.
Ex. 3 at 15.
103

interview before Petitioner began to more aggressively
treat her depression with medication and increased
monitoring. This delay in providing additional treatment
was potentially detrimental to resident 12 when one
considers that her initial depression had deteriorated
from observable signs of isolation to suicidal thoughts,
a clear indication of a worsening in her depressive
state.

With respect to care-planning, the record indicates that
her isolation was care-planned on September 1, 1993. P.
Ex. 3 at 24. Her suicidal ideation, as illustrated by
her expressing a desire to die on September 15, 1993, was
not care-planned until November 17, 1993. Id. The
approaches/actions which Petitioner's staff listed in
connection with the November 1993 entry included
encouraging the resident to socialize, encouraging
activities of choice of interest, and having cheerful
dialogue with the resident while giving care. Id. Thus,
Petitioner delayed over two months before implementing a
care plan to address resident 12's suicidal ideation.
More importantly, Petitioner delayed approximately one
month before responding to her worsening depression with
Elavil and monitoring her for suicidal ideation. Such a
delay could have had serious detrimental consequences on
her health and safety. The protections afforded
residents through the MDS assessment protocols were
obviated by Petitioner when it failed in September 1993
to record her deteriorating mental condition which would
have triggered a formal assessment of her mental state
and consideration of whether a new plan of care was
necessary to respond to the change in her condition.
Additionally, one of the mechanisms built in to the
assessment process to ensure a resident's proper care and
treatment is that a resident's care plan must be prepared
by an interdisciplinary team made up of the appropriate
persons. With respect to the care plan entries of
September 1, 1993 and November 17, 1993, there is nothing
in the record to indicate that these entries were
formulated in accordance with these protocols.

Ms. Shekell testified:

You would expect to see that somebody that has
a mood disturbance over a period of time that
it would be reflected in the assessments.
According to their assessments that has not
been identified as a problem, and the
regulation does state that the record must show
104

an accurate and concise assessment of the patient at
any time.

KkEKK

The goal is that the staff must make a complete
assessment of the patient to actually reflect
what the patient's needs are, and from that
they develop.a patient care plan for which they
care for the patient based on that assessment
of identified needs, and then they can set
goals to help the patient with the identified
problems.

Tr. 148, 150-151.

Resident 12 manifested serious problems in terms of her
psychosocial well-being and her July 30, 1993 MDS was
inaccurate with respect to her psychosocial status as of
at least September 15, 1993, or possibly as early as
September 1, 1993, which is the first indication in the
record that she wanted to isolate herself”. Moreover,
there is no evidence in the record that Petitioner ever
completed a new MDS for resident 12. While the resident
did appear to benefit from weekly group and individual
psychotherapy sessions and become less depressed, as
indicated by the progress notes for September 1993
through December 1993 (P. Ex. 3 at 16-19), her depressive
symptoms were never totally eliminated.

Based on the above, Petitioner violated the requirement
found at 42 C.F.R. § 483.20(b)(1), with respect to this
resident. Section 483.20 mandates that the resident
assessment conducted by the facility be an accurate
comprehensive assessment of the resident's functional
capacity. Sections 483.20(b)(1)(i) and (ii) mandate that
1) such assessment be "based on a uniform data set
specified by the Secretary and uses an instrument that is
specified by the State and approved by the Secretary" and
2) such assessment "describe the resident's capability to
perform daily life functions and significant impairments
in functional capacity." In short, the MDS should
accurately reflect the resident's functional
capabilities. This instrument is used to prepare a
comprehensive care plan for any medical condition
assessed by the facility as impacting on the resident's
ability to function -- the goal being to assist the
resident in attaining and maintaining his or her highest
practicable physical, mental, and psychosocial well-

2 See, P. Ex. 3 at 22.
105

being. 42 C.F.R. § 483.20(d). Here, Petitioner's
failure to maintain an accurate assessment of this
resident's condition as the level of her depression
worsened prevented the formulation of a timely
comprehensive care plan prepared using the protocols
specified by HCFA and which corresponded to her change in
psychosocial well-being.

While the July 1993 MDS may have been accurate at the
time it was completed, it no longer reflected the true
condition of resident 12's psychosocial status as of
September 1993. Petitioner failed to conduct a new MDS
in September 1993, and by leaving an inaccurate MDS in
place, it did not comply with 42 C.F.R. § 483.20(b).

By failing to accurately document resident 12's
depression in the assessment instrument, Petitioner acted
contrary to the directives of OBRA '87 and contravened
its obligation to provide appropriate "individualized
care" of high quality to its residents. Congress
intended that the resident assessment instrument
accurately describe a resident's functional capacity and
health status. See section IV. of this decision. In
imposing this obligation on a facility, Congress
recognized that a comprehensive resident assessment was
crucial to providing high quality care to a resident.
Id.

As part of its response to this deficiency, Petitioner
argued that F 272 was cited in error:

Ms. Patience finally testified that the
indicated deficiencies concerning the failure
to update assessments to conform to the
condition of the patient (asserted
inaccuracies) are not in fact the subject of
F272 but are actually addressed in F287, which
is the only F tag that covers her criticisms.

P. Br. at 47, citing Tr. 2658-2659.

At the hearing, Ms. Patience did acknowledge that, if a
deficiency was based on failure to complete an MDS after
a significant change in a resident's condition, the
appropriate citation would be F 287. Tr. 2658-2659,
2683. In addition, Ms. Patience stated that a failure to
change the MDS "could trigger other Ftags." Tr. 2683.

Ms. Patience did express her opinion that the alleged
findings concerning resident 12 would lead to a
deficiency under F 287. Id. However, contrary to what
Petitioner contends, Ms. Patience did not testify that F
287 was the only applicable citation for the alleged
106

deficiency. In response to my questioning, Ms. Patience
stated that the alleged findings relating to resident 12

could also trigger 272. We sometimes use 272
to illustrate a pattern of deficient practice
in relation to the minimum data set in the
assessment process. And, so it wouldn't be
entirely improper that it was under 272.

Tr. 2683-2684.

According to SOM 250, the regulation which is the basis
of F 287 is 42 C.F.R. § 483.20(b) (4) (iv), which states
that a facility must conduct assessments "promptly after
a significant change in the resident's physical or mental
condition". HCFA Ex. 13 at P-103. As I have discussed,
when resident 12 exhibited symptoms of major depression
and spoke of being ready to die in September 1993, these
circumstances constituted a significant change in her
psychosocial condition which warranted the completion of
a new MDs.”

# In its opening brief, Petitioner argued that
"(tjhis is clearly an area where nursing judgment
dictates when assessments should be modified" and stated
that Ms. Patience had "conceded that this was an area of
judgment." P. Br. at 119. While the judgment of
Petitioner's staff does play a role in determining
whether a resident's change in condition is a
"significant" change warranting completion of a new MDS,
HCFA has provided guidance, in the form of the SOM 250,
to facilities in exercising that judgment. As Petitioner
pointed out in its brief, Ms. Patience did testify:

Some of it is the nursing judgement [sic]; some
of it is -- are the examples that are contained
here in the 250s; some of it is contained in
the direction for the resident assessment
protocols.

Tr. 2677-2678.

Ms. Patience went on to testify that it was her belief
that resident 12's change in condition "does fall in with
some of these parameters." Tr. 2678. Ms. Patience thus
was of the opinion that the proper exercise of nursing
judgment with respect to resident 12 would take into
consideration the SOM 250 and the facility's own RAPS
instructions. I agree; nursing judgment cannot exist in
a vacuum, and with respect to resident 12, the comments
(continued...)
107

Additionally, with respect to Petitioner's contention
that "there was no "pattern" of inaccurate MDS record-
keeping in the facility" (P. Resp. Br. at 14), I find
this argument to be inapposite. To meet its burden of
proof with respect to this alleged deficiency, HCFA did
not have to prove that a pattern of inaccurate MDS
documentation existed with other residents. As stated in
SOM 250, a situation that affects a single resident may
be cited as a deficiency. There is no specific standard
that must be met. The threshold of what constitutes a
deficiency varies from situation to situation. HCFA Ex.
13 at P-29. The SOM 250 guideline does state that a
single occurrence directly related to a "life-threatening
or fatal outcome or high potential for such outcome may
be cited as a deficiency." Id. However, I do not
construe this guideline as precluding a finding of a
deficiency where such an outcome cannot be demonstrated.
This guideline is written in the permissive sense and
does not mandate that such an extreme negative outcome
must be shown to conclude a deficiency exists where there
is only one occurrence. Here, I conclude that
Petitioner's failure to comply with the cited regulatory
requirement negatively impacted on the resident's
treatment. Such a finding is sufficient to support the
existence of a deficiency.

E. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 289
(HCFA Ex. 2 at 4-5):

42 C.F.R. 483.20(b) (5) (5) Review of
assessments. The nursing facility must examine
each resident no less than once every 3 months,
(quarterly) and as appropriate, revise the
resident's assessment to assure the continued
accuracy of the assessment.

RKEKK

Based on record review and interview the
facility failed to review each resident's
assessment for continued accuracy.

“8 (...continued)

by the psychologist, care plan entries, and her
medication indicate that her mood and behavior
deteriorated sufficiently to constitute a significant
change in condition. See HCFA Ex. 13 at P-104.

Thus, arguably, the survey team should have cited F 287,
in addition to F 272, for this deficiency.
108
Findings include:

Resident 16 was incontinent of bladder on
admission 5/1/93. She was but [sic] ona
bladder training program. A licensed nurse's
note at that time indicated that the resident
would tell when she had to go. The licensed
nurse's assessment 11/11/93, indicates she is
incontinent of bladder, as does the current
plan of care. Licensed nurse's notes 12/3/93
state that she is continent, however the next
weekly summary states she is incontinent. The
nurse aide flow sheets from 12/1-12/15/93
reflect that she is continent. Licensed staff
interviewed were not sure which of these
documents were accurate. The resident has not
been accurately assessed and the care plan
updated to reflect the actual status of the
resident. On 11/7/93 an entry in the plan of
care indicates that she tries to climb out of
bed. A nursing approach to toilet the resident
when her restraints are released, is included.
There was no routine individual schedule
developed to meet the resident's needs.

Cross reference F290.

Residents medical records reviewed indicated
inaccuracies of the resident mental, physical,
and psychosocial status on an ongoing basis.
Records indicated no mood, behavioral and
psychological problems when they were in fact
receiving psychotropics, antianxiolytic,
sedative and/or hypnotic drugs. The
assessments were not congruent with the
physicians progress notes or nurses notes. The
assessments were not consistent with current
treatment needs or the current patient care
plans.

The quarterly assessments did not reflect the
residents status on the 18 elements of the
resident assessment protocol summary (RAPS).

The first part of this alleged deficiency concerns
resident 16 and the issue of whether Petitioner
accurately assessed resident 16's state of bladder
continence. HCFA argues that "neither the MDS nor the
quarterly evaluations reflected [the] significant change
in resident 16's state of bladder continence" and
contends that there was "apparent confusion and lack of
documentation in the medical record as to her actual
109

state of continence at any given time". HCFA Br. at 30,
33.

Petitioner argues, among other things, that the
resident's assessment "was accurate and did not require
change more than once every three months"; confusion on
the part of Petitioner's staff did not "violate the
regulation or require a change in the resident's
assessment because her condition was in a continual state
of change"; and "[t]here are no standards other than
nursing judgment which determine when a change in a
patient's state of continence requires a change in the
assessment other than a drastic change." P. Br. at 48.

Resident 16 was admitted to the facility on May 1, 1993.
P. Ex. 4 at 1. At the time of admission, a bowel and
bladder assessment was done, which reflected that the
resident was "inc[ontinent] of b[owel] and b[ladder] and
"not a candidate for bladder and bowel retraining
[secondary to] unawareness of bodily function." P. Ex. 4
at 11. On resident 16's MDS, which was completed on May
14, 1993, Petitioner's staff assessed her as being
incontinent of bowel and bladder. P. Ex. 4 at 3.

The medical documentation for resident 16 includes also
quarterly reviews for the quarters ending August 12, 1993
(90-day assessment) and November 5, 1993 (180-day
assessment). P. Ex. 4 at 7-8.

“ Ms. Cox testified that her findings concerning
the alleged deficiency with respect to resident 16 have
to do with only bladder incontinency. Tr. 1436.

On the MDS, continence is rated on a scale of 0 to 4,
with 0 representing continence and 4 representing
incontinence. P. Ex. 4 at 3.

4 The November quarterly review was dated 11/5/93
and, also, 11/11/93. P. Ex. 4 at 8. Ms. Cox stated at
the hearing "The assessment sheet is filled out for 8-12-
93 and 11-11-93 which is quarterly." Tr. 1190. However,
Ms. Patience explained that, because an LVN signed the
assessment on 11/5/93, that 11/5/93 would be considered
the proper date of this assessment. Tr. 2510-2511.

Based on her reasoning, I am using 11/5/93 as the date of
the November quarterly. Based on this date, the 14-day
time frame for purposes of bladder continence status is
10/22/93 - 11/5/93. Had I used 11/11/93 as the date of
the November quarterly, the 14-day time frame would be
10/29/93 - 11/11/93.

(continued...)
110

On these assessments, Petitioner's staff has. indicated in
the relevant section (Section F) that resident 16 was
incontinent of both bowel and bladder for the last 14
days of these two quarterly periods. P. Ex. 4 at 7-8.
The specific time frames, then, for which Petitioner was
assessed as incontinent of bladder for purposes of these
quarterly reviews were 7/29/93 - 8/11/93, and 10/22/93 -
11/5/93.

With respect to the August 1993 quarterly assessment, I
find that it does not appear to be one of the assessments
underlying HCFA's allegations in the HCFA 2567. With the
exception of the reference to resident 16's 5/1/93
admission, the findings alleged in the HCFA 2567 in
support of this deficiency relate to the months of
November and December 1993. Accordingly, I will not
address the August 1993 quarterly assessment, as it falls
outside of the relevant time frame focused upon by HCFA
in this alleged deficiency.

With respect to the November 1993 quarterly assessment,
which is relevant, the issue of whether or not
Petitioner's staff accurately assessed resident 16 as
being incontinent during the time frame of 10/22/93 -
11/5/93 (i.e., the last 14 days prior to the quarterly
assessment) necessitates a review of the documentation
pertinent to this time period. The October 1993 flow
sheets show that for the "Day Shift" during the period
October 22-31, Petitioner's staff had written the
notation "x3" or "3" in the boxes on the "incontinent"

4 (...continued)

I examined the flow sheet notations for the time frame of
10/22/93 - 11/5/93 and concluded that, based on these
notations, resident 16 evidenced continency status a
significant amount of the time. However, I also examined
the flow sheet notations through 11/15/93, which indicate
also that resident 16 was mostly continent for the first
half of November.

There is also a quarterly review for the quarter ending
2/10/94 (270-day assessment). P. Ex. 4 at 7. However,
because the assessment of continence in this review would
relate to the time period of 1/27/94 - 2/10/94 (i.e., the
last 14 days prior to the quarterly review), I do not
address this quarterly assessment, since it is outside of
the relevant time frame for purposes of this decision.
111

(bladder) line. P. Ex. 4 at 15.“ During the "P.M.
Shift" for this same time frame, Petitioner's staff had
written in "0" in the boxes on the "incontinent"
(bladder) line. Jd. at 16.“ For the "night shift", a
"1" was written in for 10/22, and 10/24 - 10/26, a "Oo"
was written in for 10/23, and for 10/28 - 10/31, and a
"4" was written in for 10/27. Id. at 17.“ Based on the
October flow sheet notations, it appears that, during
October 22 - 31, 1993, resident 16 was incontinent three
times daily during the "day shift," was not incontinent
at all during the "P.M. Shift", and was not incontinent
for five of the ten days during the "night shift."

The 11/1 - 11/15/93 flow sheets indicate that, during the
"night shift", resident 16 was found to be incontinent of
bladder on November 1 and 2, but was continent the rest
of the time. P. Ex. 4 at 18.” See Tr. 1435. For the
"Day Shift" during this same time period, several types
of notations were written in by Petitioner's staff: "C",
"C/I", "I/3", "x3", "C/2", "C/3", "3,50 During the

46 In the bladder section of the flow sheet,
there is also a "Continent/Catheter" line. For the "day
shift" during the 10/22 - 10/31/93 period, Petitioner's
staff wrote in "0" for these dates on the
"Continent/Catheter" line. P. Ex. 4 at 15.

“ On the "Continent/Catheter" line on the flow
sheet, Petitioner's staff wrote in a "2" for the dates
10/22 - 10/23, 10/25 - 10/31, and a "3" for the date
10/24/93. P. Ex. 4 at 16.

“ On the "Continent/Catheter" line of the flow
sheet, Petitioner's staff wrote in, for the night shift
of 10/22 - 10/31/93, a "2" for 10/22 and 10/24, a "3" for
10/23, 10/25, 10/28, and 10/30, a "1" for 10/26, a "oO"
for 10/27, and a "4" for 10/29 and 10/31. P. Ex. 4 at
17.

bid According to the legend given on the chart,
"I" represents incontinent and "C" represents continent.
In the night shift section, Petitioner's staff had
written in "I's" for November 1 and 2, 1993 and "C's" for
November 3, 1993 through November 15, 1993.

$0 6 Phe notation forms of "C/I", "C/(number)", and
"I/(number)" do not correspond to the legend and are
nowhere explained. Although Ms. Cox did not testify
specifically on these "day shift" notations, she later

(continued...)
112

"P.M. shift", there is a "C" written in for each date,
indicating that resident 16 was found to be continent
during this entire time period. P. Ex. 4 at 18.

In light of the flow sheet evidence that resident 16 was
exhibiting continent behavior a significant amount of
time during the end of October and beginning of November
1993, I find that the 11/5/93 quarterly assessment
indicating that she was incontinent is inaccurate. While
Petitioner did conduct a quarterly review, it failed to
reflect accurately resident 16's bladder continence
status, in violation of 42 C.F.R. § 483.20(b) (5).

According to the flow sheets for 11/16/93 - 11/30/93,
resident 16 was continent during the "night shift"
throughout this entire time period. P. Ex. 4 at 19.
However, with respect to the "day shift" and."P.M. shift"
for this time period, there are notations written in the
form of "C/(number)" and ""C x (number)", which are
unclear, do not correspond to the legend, and are nowhere
explained. The fact that there are "I's" and "C's"
written over each other in some of the boxes make the
entries even more cryptic.” Thus, the only conclusion I

50 (...continued)
attempted to interpret similar notations elsewhere in the
chart.

51 Had the quarterly review been accurately
completed by Petitioner with respect to her bladder
continence status, this would then have triggered the
completion of new RAPS, which, in turn, would have led to
appropriate care-planning for the resident.

There is also an interdisciplinary team note dated
11/11/93 which states, in part, "Discussion on whether
the resident has made any actual improvements/declines in
her ADL functioning. Incontinent of B & B." P. Ex. 4 at
10. Based on the flow sheet data, I find that these
notes do not give an accurate assessment of resident 16's
bladder continence status.

2 With respect to the bladder "day shift"
notations, Ms. Cox attempted to interpret them:

"Day shift it says incontinent times three, I
guess, incontinent times three, incontinent
times four, incontinent times four, and then

(continued...)
113

can make is that resident 16 was continent at least
during the night shift of the second half of November.
P. Ex. 4 at 18-19.

From November 30, 1993 - December 2, 1993, resident 16
underwent a "3-day evaluation for baseline data --
bladder training". P. Ex. 4 at 12.% The chart
indicates that, on each of these days, she was found to
be "dry" whenever checked by Petitioner's staff.
According to this chart, resident 16 was never found to

2 (...continued)

the rest of the time it says continent, across
the rest of the page. So that's four days
incontinent and the rest continent.

Tr. 1436-1437.

In attempting to get further clarification, I asked Ms.
Cox:

And then the -- so the number after the letter
would be the number of times that they were
either incontinent or continent?

THE WITNESS: Well, to me this is the number of
times they're incontinent .. .

» . . to me this is not very clear
documentation, but if you have a continent and
then have a slash, and they have a two, to me
that means something a little different than --
see, if you go back three days it says:
"Continent times" whatever that is, it looks
like a nine actually. That's under the 25th
day. .. . Some of this is a little more clear
than others. If you just have a "C/2" that
does not mean continent times,two, to me. It
could mean continent and the slash two, or it
could mean continent and perhaps in there
indicating that resident's incontinent. This
is very -- just a very poor way -- method of
charting. Tr. 1439.

With respect to the "P.M. Shift", Ms. Cox was unable to
interpret the notations. Tr. 1437-1438.

33 At the hearing, in response to my questioning,
Ms. Cox confirmed that this particular document "refers
to an evaluation to determine whether or not someone will
be a candidate for bladder training." Tr. 1431.
114

be "wet" on each of the three days. Id. An entry in the
progress notes dated November 30, 1993 reads "On B & B
training. continent X 1 -- able to ask CNA that she
wants to go to bathroom. will continue to monitor." P.
Ex. 4 at 33-34.

In her testimony regarding the "3-day evaluation for
baseline data -- bladder training" chart, Ms. Cox stated
that she did not see any indication on the chart that the
resident was incontinent, and "that would indicate that
the times that you checked her she was either dry or she
was capable of voiding. Whether they took her to the
toilet or bedpan, I don't know, it doesn't always
indicate. But it indicates that she would have some
control." Tr. 1432-1433. In the licensed nurses'
progress notes, an entry dated December 3, 1993 at the
bottom of the page reads "3 day eval. for baseline data-
bladder training completed & pt. is continent; she'll
tell when to go to the bathroom." P. Ex. 4 at 13.
(duplicated at P. Ex. 4 at 34). ‘Thus, the result of

the three-day evaluation is that resident 16 was assessed
to be continent.

Such a change in resident 16's condition constituted a
“significant change" that should have resulted in
Petitioner completing a new MDS some time following the
three-day evaluation. 42 C.F.R. § 483.20(b) (4) (iv).
Petitioner failed to do this and simply left in place the
MDS completed on May 14, 1993, which assessed resident 16
as being incontinent of bladder (and bowel). By not
updating the MDS, Petitioner plainly violated 42 C.F.R. §
483.20(b) (5), which required Petitioner, as appropriate,
to revise resident 16's assessment to assure its
continued accuracy.

Petitioner's witness, Ms. Downing, testified herself that
a resident's quarterly assessment is changed more often
than quarterly "({i]f there is a drastic or significant
change in the condition." Tr. 1796; see Tr. 1798. She
stated also that "You do a new MDS, complete new MDS if
there's a change in condition." Tr. 1796.% Although

Ms. Downing was of the opinion that "(T]here was nothing
here ({sic] a drastic or significant change that warranted

4 Although the page is a poor copy, the date of
the entry appears to be December 3, 1993.

3s On the MDS form itself, under section A, there
is a place to indicate the "reason for assessment". One
of the six choices is choice number 5 -- "Significant
change in status."
115

a new MDS" (Tr. 1796), I disagree. Resident 16 did
experience a significant change in her bladder condition.
Although she was assessed as being incontinent of bladder
on the MDS in May 1993, other medical documentation in
her record established that her condition improved
significantly such that she was no longer totally
incontinent.

I note that the record contains also a weekly summary
progress note dated 12/10/93 and flow sheets for the
period 12/1/93 - 12/31/93. P. Ex. 4 at 14, 20-21. The
12/10/93 progress note states, in part, "Incont. of B &
B". P. Ex. 4 at 14 (duplicated at p. 35).%

With respect to the December 1993 flow sheets, they
contain also notations other than a simple "C" or "I",
and which resemble notations previously discussed. P.
Ex. 4 at 20-21. For the first half of December 1993
(12/1-12/15), in the "Night shift" section, there are
some "C's" written in the chart to describe the
resident's bladder condition, as well as "C/2", "C/3",
"1/3", "I/4", and "I/O" in some of the boxes. P. Ex. 4
at 20. In the "Day Shift" section, Petitioner's staff
has written in the notations "Cx3", "C/3", "C/2", and
"c/4", Id. The notations "C/1", "C/2", and "C/3" appear
in the bladder section under the "P.M. Shift". Id. When
asked about these notations (for the period 12/1-
12/15/93), Ms. Cox stated, "Well, I see the same type
charting, some of which I don't understand, I have to
admit. And I can only say that it is not clear to me
what this means." Tr. 1441.” Notations of similar form

56 A progress note dated 12/3/93 (7:30 p)
contains a reference to resident 16's continence status.
P. Ex. 4 at 34. It states on the third line what appears
to be the following phrase: “Incontinent of B/B".
However, the first two letters of "Incontinent" are lined
through, which could indicate that "In" is being crossed
out. If this is the case, then it may be that
Petitioner's staff had mistakenly written "Incontinent"
when he/she had meant to write "continent." The manner
in which to interpret this was disputed at the hearing.

I find that it is unclear and ambiguous; accordingly, I
do not consider this entry in discussing resident 16's
bladder condition.

57 Ms. Cox had expressed the same confusion
earlier on direct examination when asked to give her
interpretation of "a C with a slash" :

(continued...)
116

appear in the nurse assistant record for the period of
12/16-12/31/93. P. Ex. 4 at 21.*

When asked about the "night shift" bladder notations for
the first half of December 1993 (12/1-12/15/93), Ms.
Downing interpreted them in the following manner®™:

It has incontinent on the 10th times three.
Incontinent on the 11th times four.
Incontinent on the 13th times, it says zero.
So, I would assume that means she was dry that

day.
Q [Petitioner's counsel]: "That's just the -- that's
just the night shift?" A [Ms. Downing]: "Right. That's
the number of times she was checked." Tr. 1777.

With respect to the "day shift" bladder notations for
this same time frame (12/1-12/15/93) (P. Ex. 4 at 20),
Ms. Downing stated "I would say it looks like she was
incontinent [sic] -- continent or dry on the day shift."
Tr. 1777. When asked about the resident's bladder
condition during the "p.m. shift", Ms. Downing testified,
"It looks like, yes she was continent on those days."

Id. Based on her review and interpretation of these
notations for all three shifts, Ms. Downing expressed her
opinion that the statement in the HCFA 2567 that the
12/1-12/15 flow sheets reflect the resident to be

37 (...continued)

.» . . It could be that the person was continent
twice, but that doesn't answer when she was
incontinent or how many times she went totally,
or it could say that she was continent but the
two were -- the three or whatever numbers there
perhaps indicates that that's the number of
times she was incontinent so it could be either
way. I'm not sure what that means.

Tr. 1039; see also Tr. 1040-1042.

8 On direct examination regarding P. Ex. 4, pg.
21, Ms. Cox did state "it's not totally clear to me, but
obviously the C means continent times three, if that
speaks for itself it means she was continent three
times." Tr. 1042.

59 In the transcript, Ms. Downing stated that the
period 12/1-12/15 is referenced on P. Ex. 4 at 16.
However, this page is a flow sheet for October 1993. The
correct page cite is P. Ex. 4 at 20.
117

continent was "inaccurate". Ms. Downing stated, "No, she
was not totally continent". Tr. 1778.

HCFA's witness, Ms. Patience, also was questioned about
the December 1993 flow sheets. With regard to the 12/1-
12/15 flow sheet (P. Ex. 4 at 20), Ms. Patience stated
the information in the chart indicated "[t]hat the
resident was continent from December 1st through December
15th -- continent of bladder." Tr. 2508. Ms. Patience
testified further that the information on the 12/16-12/31
flow sheet indicated "(t]hat the resident from December
16th through December 31st was also continent of
bladder." Tr. 2508.

The testimony of Ms. Downing and Ms. Patience concerning
the 12/93 flow sheet notations calls into question the
validity of the 12/10/93 weekly summary progress note.
Also, given that resident 16 was assessed as "continent"
following the three-day evaluation, which was completed
on 12/2/93, the weekly progress note appears to be
inaccurate. In light of the testimony of both Ms.
Downing and Ms. Patience, it appears that, while resident
16 may not have been “totally continent" during the first
half of December, she could possibly be described as
being mostly continent for the month of December. In any
event, I conclude that resident 16 was not incontinent
during December 1993.

By ignoring its obligation to comply with 42 C.F.R. §
483.20(b) (5), Petitioner was essentially representing
that between May 1993 and the time of the survey
(December 1993), resident 16 had not undergone any
changes at all with respect to her continence status and
remained totally incontinent. Such misleading and
inaccurate information about resident 16's health status
was precisely what OBRA '87 was intended to prevent with
its patient-oriented reforms. 42 C.F.R. § 483.20(b) (5)
mandates that a facility must conduct quarterly
assessments and "as appropriate, revise the resident's
assessment to assure the continued accuracy of the
assessment." Petitioner should have had updated and
accurate assessments in resident 16's medical record
which documented that her condition changed significantly
from being incontinent of bladder to either continent or
mostly continent. In sum, Petitioner's November 1993
quarterly assessment of resident 16 was inaccurate and,
based on the evidence of continence following the 3-day
bladder evaluation, there was evidence based on that data
alone to conclude a significant change in resident 16's
status had occurred to warrant a modification of her
assessment instruments. Failure to have an accurate
assessment of her continence prevented this resident from
118

attaining her highest practicable level of physical,
mental, and psychosocial well-being and potentially could
have compromised her health and safety, since she could
have been exposed to infection if continence had not been
maintained.

Ms. Cox alleged further in the HCFA 2567 that resident
16's care plan was not updated to reflect her actual
status. HCFA Ex. 2 at 5. This allegation pertaining to
resident 16's care plan is extraneous to the regulation
and, therefore, I do not consider it.@

Petitioner argues that Ms. Patience acknowledged that
there are no specific documentation standards governing
what length of time of continence or incontinence is
needed to be demonstrated in order to necessitate
changing a resident's assessment. P. Br. at 55.
Petitioner avers that, outside of a drastic change ina
resident's condition, nursing judgment should control as
to when a resident's assessment should be revised due to
a change in continence status. Id. Petitioner's
argument is without merit. I find that Ms. Cox did, in
effect, defer to nursing judgment in reviewing resident
16's medical chart. Ms. Cox based her findings on
notations and entries written by Petitioner's staff and
found that Petitioner's staff made a determination at one
point in time that the resident had become continent.
Based on this assessment of the resident by Petitioner's
staff, Ms. Cox then concluded that Petitioner should have
completed a new assessment of the resident which
accurately stated her improved bladder condition.
Contrary to what Petitioner argues, it appears that Ms.
Cox gave great weight to the nursing judgments contained
in the various medical documents.

Ms. Cox testified also that "(t]he nurse aide flow sheets
and the weekly nurses' summaries were in conflict with
each other compared to their bladder assessment that was
finished 12-3. .. . None ever [sic] that information
agreed." Tr. 1240-1241. Ms. Cox testified further that
Petitioner's staff "were not sure which documents were

accurate." Tr. 1241. In response to these claims,
Petitioner argued that the "confusion of the licensed
staff is not a violation of the cited regulation." P.

Br. at 55. While section 483.20(b)(5) does not address
internal consistency of documentation per se, it is
evident that the objective of this regulation is to

« Ms. Cox testified that the regulation concerns
“quarterly [assessments] and revising as appropriate to
insure accuracy." Tr. 1190.
119

describe a resident's condition and health status as
accurately as possible. The fact that the documents in
resident 16's medical chart appear to demonstrate some
internal inconsistency underscores further the inaccuracy
of the recordkeeping with respect to her bladder
condition.

The next part of the deficiency, as set forth in the HCFA
2567, alleged:

On 11/7/93 an entry in the plan of care indicates that
she tries to climb out of bed. A nursing approach to
toilet the resident when her restraints are released, is
included. There was no routine individual schedule
developed to meet the resident's needs.

HCFA Ex. 2 at 5.

This allegation is extraneous to the regulation and,
therefore, I do not consider it.

With respect to the group of allegations in the HCFA 2567
concerning "Residents medical records reviewed indicated
inaccuracies of the resident mental, physical, and
psychosocial status on an ongoing basis... ", Ms.
Shekell stated that she "contribute(d] to writing [this]
deficiency." Tr. at 162. Apparently, another surveyor,
Ms. Chute, who has since passed away, also had reviewed
some of the records which are the basis for these
findings. Tr. at 181, 193.

Ms. Shekell testified that resident 12, who had been the
subject of another alleged deficiency (F 272), was one of
the subjects of this group of allegations. Ms. Shekell
stated that resident 12's quarterly reviews failed to
indicate that she had mood problems and were thus
inaccurate. Tr. 176-178; P. Ex. 10 at 16. Resident 12's
chart contains quarterly reviews dated October 27, 1993,
January 28, 1994, and April 22, 1994. P. Ex. 3 at 7. I
do not discuss the latter two quarterly reviews since
they are outside of the relevant time frame for purposes
of this decision.

With respect to resident 12's 10/27/93 quarterly review,
I find that HCFA did not prove that it is inaccurate. on
the 10/27/93 quarterly review, Petitioner's staff had
written in a zero in section H.2 next to the phrase "Sad
or anxious mood intrudes on daily life over last 7 days -
not easily altered, doesn't ‘cheer up.'" The zero
represents that resident 12 had not displayed this mood
pattern during the relevant time frame, i.e., October 20
- 27 1993. The progress notes for October 1993 show that
120

the resident's progress toward stabilizing her depressed
mood was at about the same level as in September. P. Ex.
3 at 17. An entry dated October 6 states: "spirits up --
probably due to word (incl. pictures) from family in
Philippines. Another entry dated October 27 states that
the resident "has established ties c grp members & is
speaking more to them in & outside of grp. She also is
able to converse more openly, a big step." Id. Based on
these entries, the 10/27/93 quarterly review is not
inaccurate.

However, in examining the documentation outside of the
October 1993 quarterly review time frame, I previously
concluded in section X.D. of this decision that resident
12's July 30, 1993 MDS was inaccurate with respect to her
psychosocial status as of at least September 15, 1993, or
earlier, possibly September 1, 1993, which is the first
indication in the record that she wanted to isolate
herself (P. Ex. 3 at 22). There is no evidence in the
record that Petitioner ever completed a new MDS for
resident 12. Because Petitioner failed to "assure the
continued accuracy" of resident 12's assessment
instrument", I conclude that it violated 42 C.F.R. §
483.20(b)(5) with respect to resident 12.

Additionally, Ms. Shekell testified that P. Ex. 9
(resident G.B.) was one of the resident records that was
“part of the survey team's basis" for this alleged
deficiency. Tr. at 195. Ms. Shekell stated that she did
not herself view the resident whose record is P. Ex. 9;
she believed that this resident's record had been
identified and reviewed by Ms. Chute. Tr. at 191-193.

In discussing resident G.B., Ms. Shekell stated that
there was an inconsistency between his MDS, which
indicated that the resident did not have any mood
problems, and his care plan, which indicated that he was
taking antidepressant medication and had an episode of
crying on February 24, 1993. Tr. 195-198. See P. Ex. 9
at 2, 5. Ms. Shekell testified also that a Social
Services note dated November 30, 1993 stated that the
resident was "taking an antidepressant to reduce episodes
of crying related to neurogenic pain. Social Services
will provide emotional support to resident during one on
one visits." Tr. at 199-200; P. Ex. 9 at 19. Ms.
Shekell stated further that another entry dated December
13, 1993, written by a licensed social worker mentioned,
among other things, that "referral to psychologist is
appropriate [to] address his refusal of treatment." Tr.
at 201. See P. Ex. 9 at 20. Ms. Shekell noted that,
according to the Physician Orders, the resident had been
on Prozac, which was discontinued sometime around May 24,
121

1993, at which time the resident was started on 25 mg. of
Desipramine, which was increased to 50 mg. after four
days. Ms. Shekell stated that a Physician Order dated
November 16, 1993 indicated that the resident was
receiving 150 mg of Desipramine daily (at bedtime) for
depression. Tr. at 201-202; P. Ex. 9 at 21, 23. Ms.
Shekell expressed her opinion that this "would indicate
to [her] that the patient had an escalating problem for
the doctor to increase his orders to that extent." Tr.
at 202.

In addition, HCFA argued that resident G.B.'s quarterly
reviews dated May 28, 1993, August 23, 1993, and December
1, 1993, did not indicate that he had any mood or
behavior problems. P. Ex. 9 at 6-7; HCFA Br. at 36.%

Based on Ms. Shekell's testimony and the record before
me, the August 23, 1993 quarterly review, which indicated
that resident G.B. had no mood problems in the last seven
days, is accurate. A social services note dated 8/23/93
stated, among other things, that "Episodes of crying are
being monitored by nursing staff [with] a total of 6 from
May - July." P. Ex. 9 at 16. Based on this information,
G.B. apparently had not experienced any mood problems in
the month of August.

However, I find that Petitioner inaccurately assessed
resident G.B.'s mood problems in the quarterly reviews
dated May 28, 1993 and December 1, 1993. According to
these assessments, G.B. did not display any "sad or
anxious mood" over the last seven days of these two
quarterly periods (section H.2.). P. Ex. 9 at 6.
However, it cannot be disputed that G.B. was experiencing
depression, for which he took Prozac, and that, in late
May, he was discontinued from Prozac and put on
Desipramine. Moreover, the 11/30/93 Social Services note
which mentions that G.B. is "taking an antidepressant to
reduce episodes of crying related to neurogenic pain. SS
will provide emotional support to resident during 1:1
visits" (P. Ex. 9 at 19) is further evidence that G.B.
was experiencing mood problems. These quarterly
assessments are thus inaccurate, and Petitioner's failure
to maintain an accurate assessment of G.B.'s psychosocial
status represented a breakdown in the assessment process
which could have a potentially negative impact on G.B.'s
psychosocial well-being and the treatment of his
depression. I thus find that, with respect to resident
G.B., Petitioner violated 42 C.F.R. § 483.20(b) (5).

6 Resident G.B. was admitted on February 17,
1993. P. Ex. 9 atl.
122

Resident G.B.'s chart does contain a 2/24/93 care plan
entry noting "Episode of crying", and a corresponding
objective for G.B. to "have less than 3 episodes x 1
month; x 3 months", which is further dated May 24, 1993,
August 24, 1993, and November 24, 1993. P. Ex. 9 at 2.
While it appears based on this information that
Petitioner was taking into account resident G.B.'s mood
problem through his care-planning, I do not conclude that
these care plan entries were formulated in conjunction
with the proper assessment protocols. Because Petitioner
did not have in place accurate assessments, upon which a
care plan is based, it is questionable whether the
protocols mandated by the regulations were in place and
used with respect to resident 12.

Petitioner also should have completed a new MDS for
resident G.B. some time following the 12/13/93 multi-
disciplinary report entry which noted that he was
refusing treatment. P. Ex. 9 at 20. Because there is no
date for resident G.B.'s MDS which is in the record
before me, I assume that it was completed upon G.B.'s
admission on February 17, 1993 (P. Ex. 9 at 13), or
within 14 days of his admission.” According to this

MDS, G.B. was not resisting care. P. Ex. 9 at 5.

However, when resident G.B. began to refuse treatment in
December 1993, this represented a significant change in
behavior. Petitioner should have completed a new MDS for
G.B.,. but failed to do so. As I have discussed earlier,
the MDS must accurately reflect the resident's functional
capabilities. By failing to “assure the continued
accuracy" of resident G.B.'s assessment instrument,
Petitioner further violated 42 C.F.R. § 483.20(b)(5) with
respect to this resident.

As for the last part of the allegations in the HCFA 2567
with respect to F 289 ("The quarterly assessments did not
reflect the residents status on the 18 elements of the
resident assessment protocol summary (RAPS)."), HCFA
stipulated at the hearing that it was no longer asserting
this part as a basis for a violation under F 289. Tr.
1832-1834.

®@ The first page of the MDS, which would have
signatures and dates, was not included in the exhibit.
123

F. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 290
{HCFA Ex. 2 at 6):

42 C.F.R. 483.20(b) (6) (6) Use. The results of
the assessment are used to develop, review, and
revise the resident's comprehensive plan of
care, under paragraph (dad) of this section.

KREKK

Based on record review and interview the
facility failed to review and revise each
resident's plan of care.

Findings include:

Resident 16 was assessed as being incontinent
of bladder at the time of admission. When the
resident's condition improved and she was
continent the plan of care was not changed.

Cross reference F 289.

With respect to this alleged violation, HCFA notes that
it involves one of the residents who had been the subject
of F 289. HFCA asserts that, while the deficiency under
F 289 was premised on Petitioner's failure to "review and
revise the assessment for resident 16", this deficiency
under F 290 "concerned the facility's failure to use the
results of the most current assessment of the resident's
condition with respect to bladder continence to revise
her Comprehensive Care Plan." HCFA Br. at 37.

Petitioner contends that "{a] finding of a deficiency
under F290 is dependent upon the existence of an [sic]
deficiency under F289 ...". P. Br. at 58. Petitioner
contends further that "[t]here is a significant
evidentiary problem because the patient's plan of care
was apparently not put in evidence by HCFA at the
hearing. . .". Id. at 59. Petitioner alleges that the
relevant plan of care was not made part of the record
before me and, thus, HCFA has failed to prove this
deficiency. Id.

I note that, in testifying that resident 16's care plan
was not updated to account for her change in bladder
condition (Tr. 1442), Ms. Cox stated that she didn't have
the care plan before her. Tr. 1238, 1239, 1247, 1442.
While the possibility exists that there may be other care
plans for resident 16 which were not included among the
medical documentation comprising P. Ex. 4, my analysis of
124

whether or not Petitioner was deficient in resident 16's
care-planning rests solely on what I admitted into
evidence, my previous analysis of F 289 and Petitioner's
failure to rebut Ms. Cox's observations cited in the
deficiency by offering into evidence a care plan in
variance with her observations.

The two relevant care plan entries dated May 1, 1993 and
November 7, 1993 which are included in P. Ex. 4, at pp.
22-23, note resident 16's incontinency, but make scant
reference to her condition. In the November 7, 1993 care
plan, in the "Patient Problems/Needs" column, there is an
entry that says "At risk for impaired skin integrity
related to: incontinence, immobility." P. Ex. 4 at 22.
In the "Approaches/Actions" column of this care plan,
there is an entry that says "Cleanse & dry skin PRN after
incontinence." Id. The care plan dated May 1, 1993
contains an approach/action to "Toilet and/or check for
incontinency when restraints are released." P. Ex. 4 at
23.

As I concluded in my analysis of F 289, resident 16 was
mostly continent for the first half of November 1993 and
also was continent at least during the night shift of the
second half of November. P. Ex. 4 at 18-19.

Furthermore, upon completion of her three-day evaluation
for bladder training on 12/3/93, Petitioner's staff
assessed resident 16 to be continent and that "she'll
tell when to go to the bathroom." Id. at 13 (duplicated
at P. Ex. 4 at 34). However, nowhere in the above-
mentioned care plans does Petitioner's staff mention
resident 16's improvement in bladder condition from
incontinency to continence.“ Thus, they were

inaccurate. The obvious purpose of the care plan is to
implement procedures which are correlated to the findings
from the comprehensive assessment of the resident. Here,
the resident was demonstrating an ability to control her
bladder. This is a very favorable event, since it would
likely enhance her well-being and reduce the opportunity
for infection. Under OBRA, Petitioner is responsible for
providing this resident with services necessary to attain

® The record does not contain a care plan for this
resident that is consistent with my finding that her
incontinent status changed to continent. It is not
necessary for me to have the particular care plan that
Ms. Cox may have reviewed during the survey. The record
is sufficiently clear that whatever care plan she may
have seen failed to reflect the resident's change in
continency. Her testimony is credible because it is
supported by the record as a whole.
125

or maintain her highest practicable physical, mental, and
psychosocial well-being as required under 42 C.F.R. §
483.25. Thus, Petitioner was required to follow up on
these indications of an ability to be continent and
institute procedures which would reinforce such
beneficial behavior by the resident in order to ensure
that her continence is maintained. The care plan is the
vehicle in which those procedures are documented for
Petitioner's staff who treat this resident. This was not
done and is violative of the regulations.

Petitioner thus violated 42 C.F.R. § 483.20(b) (6) by
failing to revise resident 16's care plan once she was
assessed by Petitioner's staff to be continent. Such
failure had the potential to cause a negative outcome for
this resident.

G. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 292
(HCFA _ Ex. 2 at 6-7):

42 C.F.R. 483.20(c)(1) (i) Each assessment must
be conducted or coordinated with the
appropriate participation of health
professionals.

KEKKK

Based on observation and medical record review
it was determined that the comprehensive
assessment was inaccurate and did not include
the participation of all health professionals.

Findings include:

Resident 13's comprehensiv [sic] assessment was
dated 12/10/93. Section E-4 for body control
problems indicates only a balance problem.
Observation of the resident and review of the
medical record revealed that the resident has
multiple join [sic] contractures, progressive
weakness, loss of mobility and a decrease in
independent transfers. The comprehensive
assessment is inaccurate and does not
correspond to the plan of care.

During the survey, the surveyor noted that, with regard
to resident 13, his comprehensive assessment was
inaccurate and did not correspond to the plan of care.
HCFA Br. at 38. Resident 13's comprehensive assessment,
dated December 10, 1993, indicates only a balance problem
under Section E4 (Body Control Problems), although
126

observation of the resident and review of his record
revealed other physical problems. P. Ex. 20 at 4; HCFA
Ex. 2 at 7. This section was completed by a licensed
vocational nurse (LVN). Id. at 3.

When asked what contractures are, Ms. Patience stated:

{(t]hey're portions of the body that are bent
permanent -- bent at an angle and require, if
they're -- if the joint is going to straighten, then
it requires some sort of therapy, either with a --
restorative aid or with a physical therapist.

Tr. at 2537.

Ms. Patience noted also that the resident's care plan
states that resident 13 had multiple joint contractures
as of December 10, 1993. P. Ex. 20 at 8. However, the
minimum data set, also dated December 10, 1993, in the
section designating contracture to arms, legs, shoulders,
or hands, is blank. Id. at 4; Tr. at 2538.

Ms. Patience expressed her belief that it is important to
a resident's health and safety that contractures be noted
on the MDS. Tr. 2539. It was her opinion that, on
admission, if a resident has contractures, the failure to
note them is not the type of omission on the MDS that can
be corrected within the 14 days allowed for correction of
"errors" on the MDS. Id. Ms. Patience testified that

{c]Jontractures aren't things that are easily missed.
And, if they didn't for whatever reason pick it up
when the resident first came in, then I would think
that you would need to do a whole new minimum data
set because it does have impact on whether or not
the resident's going to be able to ambulate, feed
themselves . . . that's a pretty important component
and if that was missed, then they may have missed
other things as well.

Tr. 2539-2540.

Ms. Patience stated further that "[w]je would expect, as
far as the contracture go, for it to designate exactly
where, what the degrees were of the contracture, in other
words, how severe the contracture was." Tr. 2540-2541.

Ms. Patience testified that although the rehabilitation
screen notes the resident's contractures, it does not
"correct" the inaccurate information on the MDS, nor can
it be used in place of the MDS. Tr. 2541. HCFA argues
that, more importantly, the MDS does not contain the
127

signature of the physical therapist, Donna Hambright, who
authorized the rehabilitation screen (see P. Ex. 20 at
3), and was "the one individual who apparently did at
least recognize the existence of [the resident's]
contractures." HCFA Br. at 40-41.

Petitioner argues that the surveyor's findings do not
make a reference to a failure of participation of any
health professional and thus do not constitute a
violation of the regulation. P. Br. at 59. Moreover,
Petitioner contends that the surveyor's findings "refer
to an alleged inaccuracy in the assessment concerning a
patient's physical condition, i.e., the allegation is
that the assessment refers only to a balance problem
whereas the resident has joint contractures, progressive
weakness, loss of mobility and a decrease in the ability
to transfer independently." P. Br. at 60-61. Petitioner
argues that even if the comprehensive assessment was
inaccurate and did not correspond to the care plan, "the
alleged findings have nothing to do with the regulation
in question and there has therefore been no adequate
notice of the deficiency to which [P]etitioner is
required to respond." P. Br. at 61. Petitioner believes
that the information regarding resident 13's contractures
and other physical problems was accurately assessed
because "this information was contained in a
rehabilitation screen performed by an appropriate health
care professional. The rehabilitation screen is part of
the assessment." P. Br. at 60; P. Resp. Br. at 17-19.
Petitioner argues further that "there is nothing in the
record to indicate that the location of the screen vis a
vis in the MDS form or its contents adversely affected
the patient's health, i.e., no evidence of any negative
outcome." P. Resp. Br. at 19.

The purpose behind 42 C.F.R. § 483.20(c) is to assure
that the appropriate health professionals complete a
resident's assessment accurately. As discussed earlier
in this decision, the assessment instrument is the MDS.
The accuracy of the MDS is thus dependent upon the
appropriate health professionals completing the
appropriate sections. By signing their names to the MDS,
Petitioner's staff certifies that they have completed
their respective sections accurately and have acted in
coordination with each other in the formulation of the
MDS.

I conclude that the rehabilitation screen is part of the
assessment process, but is not part of the assessment
instrument. The physical therapist, after completing
resident 13's rehabilitation screen, should have
participated also in formulating the body control
128

problems section of resident 13's MDS. Although a LVN
completed the body control problems section on the MDS,
she was not the appropriate health professional to
complete this section.

I find, however, that Petitioner's failure to involve a
physical therapist in the completion of the MDS did not
negatively impact the resident. The omission of
contractures on the MDS did not adversely impact the
completion of the other sections because the other
sections appear to be accurately completed. P. Ex. 20 at
4. It is therefore likely that Petitioner's staff did
take into account the fact that this resident has
contractures. Moreover, on the MDS, it appears that the
appropriate actions were triggered, i.e., it appears that
Petitioner completed the appropriate RAPS for this
resident. Furthermore, the resident's care plan reflects
his contractures and is thus accurate. A care plan entry
dated December 10, 1993, noted that the resident had
multiple joint contractures and set forth objectives
which included decreasing the resident's knee
contractures and increasing his ankle range of motion.

P. Ex. 20 at 8. I conclude that there is no evidence
that the resident suffered any harm or that a potential
for harm existed. While the failure to use a physical
therapist to complete the Body Control section of the MDS
should have been brought to the attention of Petitioner,
it should not have been cited as a deficiency. It
clearly was a minor omission that did not compromise the
care of this patient. Accordingly, I find that
Petitioner did not violate 42 C.F.R. § 483.20(c) (1).

H. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 295
HCFA_Ex. 2 at 7-9):

42 C.F.R. 483.20(d)(1) (1) The facility must
develop a comprehensive care plan for each
resident that includes measurable objectives
and timetables to meet a resident's medical,
nursing, and mental and psychosocial needs that
are identified in the comprehensive assessment.
The plan of care must deal with the
relationship of items or services ordered to be
provided (or withheld) to the facility's
129

responsibility for fulfilling other
requirements in these regulations.%

KKKKK

Based on observation, interviews, and medical
record review it was determined that staff
failed to develop a comprehensive care plan for
each resident based upon the comprehensive
assessment.

Findings include:

Resident #1 was admitted to the facility on
2/1/93. The physician wrote an order on
2/11/93 that she may self administer
medications and to store them at her bedside.
Neither of these special needs were addressed
on resident #1's plan of care until 12/2/93.
Approaches for the self administration of
medication and bedside storage included the
following:

1. Ordered 2/11/93 may have own medications at
bedside.

2. Check with resident about the time in
administering medication.

3. Check the medication container by the date
the medication was taken.

4. Count the medication in the bottle and log
it as she took it.

5. Monitor as scheduled in administering her
meds. Educate resident re: self administration
of meds: Remind to be careful with self
administration of meds; to list the meds she
have [sic] taken each day.

6. Observe resident for an [sic] unusual
occurrences and remind resident to report to
charge nurse if complaints of persistent

“ The latter sentence does not appear in the
regulatory language of 42 C.F.R. § 483.20(d)(1). For
this reason, I am ignoring this sentence. The sentence
in question apparently is a quotation from the SOM 250.
130

headache, projectile vomiting, increased temp,
etc.

Interviews with licensed nurses and resident #1
revealed that this resident refused to allow nurses
to observe her administer her medications. She also
refused to let the nurses check her medication
bottles. The facility failed to develop the
approaches to address her needs for 10 months and
failed to follow the plan of care after it was
developed.

Medical. record review revealed inconsistencies
between the assessments, RAPS, and patient care
plan indicating a lack of coordination of
information collected during the assessment
process as well as the evaluation of the care
needs from the entire interdisciplinary care
team. The patient care plan must reflect the
residents care needs as reflected by the
ongoing assessment and changing needs.

Cross Reference - F297

Petitioner argues that it did develop a care plan for
resident 1. P. Br. at 67. Petitioner contends that
HCFA's criticism is based on "an alleged failure to
follow the developed care plan, which is not a violation
of the regulation." Id. Moreover, Petitioner asserts
that it did follow the care plan. It further argues that
"([njone of [the witnesses'] testimony has anything to do
with the development of a comprehensive care plan but
rather with its implementation or modification." P. Br.
at 80.

At the hearing, Ms. Shekell testified that she did not
write this deficiency. Tr. 432, 836. She stated that
the deceased surveyor, Ms. Chute, had prepared this
deficiency. Tr. 369.

Ms. Shekell testified that the actual description of the
deficiency in the HCFA 2567 is set forth at page 9 of
HCFA Ex. 2 and begins with the sentence "Interviews with
licensed nurses and resident #1 revealed that this
resident refused to allow nurses to observe her
administer her medication. . ." Tr. 386-387, 391-392.
Ms. Shekell stated that she was not present when the
interviews with the licensed nurses and resident 1
occurred. Tr. 397. She did not know what particular
time period had been discussed in Ms. Chute's interviews
with the nurses. Tr. 408. Ms. Shekell testified that
she did not discuss with Ms. Chute what was said at those
131

interviews. Tr. 397-398. Ms. Shekell testified further
that she "remember{ed] Miss Chute during our team
meetings discussing with the team that she had identified
a patient that was taking her medications without being
properly monitored." Tr. 399.

In describing the deficiency, Ms. Shekell testified as
follows: "Well, they have stated in their approach that
they are going to monitor and check the patient and count
the medications and then they couldn't do that. So then
they needed to develop another Plan of Care that, so that
they could adequately monitor the medications." Tr. 402.
In addition, this testimony was elicited from her:

A (Ms. Shekell}: As I stated yesterday, I am
reviewing this record in the absence of the
evaluator that wrote the deficiency. It is not
totally clear to me what she meant by the 10th
month. I can only make the assumption that the
original physician's order was written that the
patient may have her meds at the bedside, was
written on February the 11th and was -- this
care plan was initiated on 12-2, approximately
10 months lager [sic].

Q [Counsel for Petitioner}: And so you're
making the assumption that the care plan was
initiated as a result of an entry made 10
months before. Am I understanding you rightly?

A [Ms. Shekell]: That's what it appears to me.
Tr. 825.

In response to my inquiry whether a care plan should have
been prepared in response to the physician's 2/11 order,
Ms. Shekell responded "[t]Jhat's -- yes there should have
been." Tr. 414-415; see Tr. 2556-2557 (testimony of Ms.
Patience). Ms. Shekell testified that the only care plan
she had before her was the one dated December 2, 1993.
She stated "(i]f I had the entire medical record, I would
be able to tell you whether they had developed one and
then discarded it and then developed another one." Tr.
415. In questioning Ms. Shekell, counsel for Petitioner
indicated that the only care plan that was prepared for
this resident reflecting self medication was the plan of
care completed on December 2, 1993. Tr. 417.

It appears that the surveyor determined that Petitioner
had violated the regulation cited here because (1)
Petitioner failed to care-plan the physician's order of
February 11, 1993 that she "may have own meds at bedside"
132

until approximately ten months later, on December 2,
1993; (2) once it became apparent that the December care
plan approaches could not be successfully carried out due
to resident 1's refusals and her own physical condition,
Petitioner should have, but failed, to develop a care
plan for resident 1 that enabled Petitioner's staff to
effectively monitor her taking of her medications; and
(3) despite the statement in the 12/2/93 care plan that
Petitioner's staff would monitor resident 1's
administration of her medication, no monitoring of
resident 1's bedside medications occurred until December
6, four days later.

The medical chart for resident 1 which has been admitted
into evidence contains a physician's order dated 2/11/93
which states that she "may have own meds at bedside." P.
Ex. 21 at 29.8 Based on the record, however, there is
no indication that Petitioner's staff contemporaneously
care-planned the 2/11/93 physician's order. Although
resident 1's medical chart does contain an earlier care
plan containing February 1993 entries, nowhere on this
care plan does Petitioner mention the 2/11/93 order. See
P. EX. 21 at 12. The February 1993 care plan would have
been an appropriate document in which Petitioner could
have contemporaneously noted the 2/11/93 physician's
order. However, the record contains only a 12/2/93 care
plan relating to self-medication. P. Ex. 21 at 30.

On this 12/2/93 care plan (P. Ex. 21 at 30), in the left-
hand column ("patient problems/needs"), Petitioner's

staff has written "Info.: Administer some of her
medications. Info.: may have own meds @ bedside (as
ordered)." Petitioner's staff wrote also that there was
a “potential for taking too many meds too often." P. Ex.

21 at 30. In the far right column ("Approaches/Actions")
of the care plan, Petitioner's staff listed the
“approaches/actions" to be followed with respect to
resident 1's self-administration of medication. Id. The
first "approach/action" states: "Ordered 2/11/93 may have
own meds @ bedside." (emphasis added). The other
“approaches/actions" focused on such things as checking
resident 1 with respect to the time for administering her
medicines, counting the medication in the bottles and
logging it as she took it, and monitoring her as
scheduled. Id. (I will not repeat verbatim the
approaches here because they were included among the
findings in the HCFA 2567, which I have already listed
above.)

65 Resident 1 was admitted to the facility on
February 1, 1993. P. Ex. 21 atl.
133

The regulation requires that Petitioner have a care plan
in place that "includes measurable objectives and
timetables to meet a resident's medical, nursing, and
mental and psychosocial needs" and describes the
“services that are to be furnished to attain or maintain
the resident's highest practicable physical, mental, and
psychosocial well-being." This Petitioner did not do,
for it failed in February 1993 to contemporaneously care-
plan the physician's 2/11/93 order that resident 1 could
have her own medications at bedside, in violation of 42
C.F.R. § 483.20(d) (1).

Resident 1's medical chart contains also two assessment
forms titled "Self-Administration of Medication
Assessment", dated April 1, 1993 and December 2, 1993.
P. Ex. 21 at 26-27.% According to the April 1, 1993
assessment, which was signed by a licensed nurse and a
physician, resident 1 was evaluated as not being mentally
or physically able to administer medication. P. Ex. 21
at 27. Petitioner's staff wrote that she "gets confused
about medication being given. [0]ften forgets" and
concluded that she was not a candidate for safe self-
administration of medications. Id. Following this
assessment, HCFA argued, in effect, that Petitioner was
obliged to develop a care plan which set forth measurable
objectives and timetables correlating to resident 1's
status that she should not be permitted to self-
administer medications.” See Tr. 2557. Counsel for
HCFA seeks such a finding. HCFA Resp. Br. at 28. I am
unwilling to make this finding because there is no
reference in the HCFA 2567 relating to any intervening
circumstances warranting additional care plans.
Petitioner has not been put on notice of this particular
alleged deficiency. I indicated to the parties that I
would construe these deficiencies in a manner consistent

6 Ms. Shekell explained that self-administration
of medication "means that the patient has the ability to
have medications in their room and take them as they feel
that they need them or per -- for example, if they wanted
to take some cough medicine they could take a cough
medicine-and have it at their bedside and give it to them
whenever they felt that they needed it." Tr. 217.

7 There is no indication that, based on the
documents comprising resident 1's medical chart which is
in evidence, the earlier 2/11/93 doctor's order
permitting resident 1 to have her medicines at bedside
was withdrawn or changed.
134

with the due process principles of notice and opportunity
to defend.®

According to the assessment dated December 2, 1993, which
also was signed by a licensed nurse and a physician,
resident 1 wished to self-administer medications. P. Ex.
21 at 26. She was found mentally and physically able to
do so. Petitioner's staff concluded that resident 1 was
a candidate for safe self-administration of medications.
id.

Petitioner argues that the 12/2/93 care plan entries
(discussed above) were written in conjunction with this
12/2/93 self-administration assessment. P. Br. at 73. I
have nothing in this record which allows me to identify
with any certainty what was the precise trigger for the
12/2/93 care plan. Whether it was the 2/11/93 physician
order or the 12/2/93 assessment, once Petitioner was
aware of the 2/11/93 order, it should have initiated a
care plan consistent with such order. This was not done.
Moreover, Petitioner's contention is plainly inconsistent
with the fact that the 12/2/93 care plan specifically
mentions the 2/11/93 physician's order.”

bal In light of HCFA's position that there should
have been a care plan in April 1993 in response to the
4/1/93 assessment that resident 1 could no longer self-
medicate, I find that the statement in the HCFA 2567,
"The facility failed to develop the approaches to address
her needs for 10 months. . ." is not accurate. HCFA Ex.
2 at 9. According to the record, the actual time frame
during which resident 1 was capable of self-medicating
appears to have been from February 11 to April 1, 1993.
For the time period of April 1993 to December 1993,
Petitioner cannot be said to have failed to have a care
plan in place for resident 1 that allowed self-
medication, since, as of April 1, 1993, she was no longer
a candidate for safe self-administration of medications.
The April 1993 assessment, moreover, has no bearing on
the 12/2/93 care plan.

6 Interestingly, Petitioner's own written
procedures regarding self-administration of medications
state, among other things, that "Licensed nurses will
assess the safety and compliance of self administration
of medication by the resident, and document on weekly
nurses progress notes. The patient care plan will
reflect information regarding self-administration by the
resident." P. Ex. 21 at 35. Petitioner thus violated
its own written procedures, as well as 42 C.F.R. §
483.20(d) (1).
135

It is not entirely clear from reading the HCFA 2567 as to
when resident 1 refused to allow nurses to observe her
taking her medicines and to check her bottles. However,
I note that, as part of resident 1's medical chart,
Petitioner included her medication record for December
1993 (P. Ex. 21 at 31-34). Additionally, there is an
interdisciplinary team note dated 11/30/93 which states,
in part, "Resident chose not to attend PCP. All
disciplines present & participated. . . Refusal of
antibiotic discussed." (At the end of this entry, there
are four signatures.) P. Ex. 21 at 28. My discussion
will thus focus on these particular documents.

Resident 1's December 1993 medication record (P. Ex. 21
at 31-34) establishes that there were instances in
December when resident 1 refused to allow Petitioner's
staff to monitor her self-administration of her
medications. In explaining the medication record, Ms.
Shekell stated that the initials in the boxes belonged to
whichever nurse had been providing the care during that
particular shift. Ms. Shekell testified that the
initials, when present, were "supposed to mean" that the
nurse “either saw the patient take the medication or
administered the medication." Tr. 421. She testified
further that a circle around an initial "would normally
indicate that the patient refused the medication" and
could also represent that the patient "refused to allow
monitoring of the medication." Tr. 422. Elsewhere, Ms.
Shekell elaborated that, if a medication “is not given,
it's circled" and "the reason for is documented other --
some place else in the medical record." Tr. 426-427."

On one page of resident 1's December 1993 medication
record is listed the medicines Riopan Plus, Robitussin,
and Sucrets. Under each of these medicines, Petitioner's
staff has written "may keep at bedside and monitor q

7 Petitioner questioned Ms. Shekell on this
medication record.

a Ms. Shekell testified that the medication
record found at P. Ex. 21 at 31 consisted only of the
front side and was missing the back side. She stated
that, if a resident refused to take medicine, staff
"would put date and time and state that the patient
refused to take their medication for whatever reason."
Tr. 426.
136

shift." P. Ex. 21 at 31.” Among the charting notations
for these medicines, however, one finds instances where
circled initials were recorded.” Thus, based on this
evidence, resident 1 apparently refused several times to
allow Petitioner's staff to monitor her self-
administration of medications.

Petitioner's counsel argues that "(t]he number of
instances where there was refusal to permit monitoring of
self-medications compared with the number of instances
where the care plan was followed and monitoring occurred,
did not justify a change in the comprehensive care plan."
Pp. Br. at 68. I find unpersuasive Petitioner's argument.
Although Ms. Shekell appeared to agree with Petitioner's
counsel that resident 1 "refused a very small number of
times out of the total" (Tr. 423), the fact remains that
refusals did occur. Such refusals on the part of
resident 1 were not minor or inconsequential. Resident
1's actions of non-compliance directly conflicted with
the 12/2/93 care plan approaches. Ms. Shekell testified:

And then this care plan was not further
developed when they saw that they couldn't --
that it was ineffective. In other words, staff
could not monitor, the patient wouldn't let
them count her medications.

Tr. 417.

2 For December 1993, resident 1 was permitted
also to keep Antivert, vitamin C tablets, multi-vitamin
tablets, and Premarin vaginal cream at her bedside. P.
Ex. 21 at 33. Petitioner's staff indicated for each of
these medications that the resident was to be monitored.

3 In the Riopan Plus and Robitussin sections,
there are two instances of a circled initial recorded at
the 3-11 shift for both December 17 and December 21. P.
Ex. 21 at 31. In the Sucrets section, there is a circled
initial recorded at the 3-11 shift for December 17 and
what could be a circled initial at the 3-11 shift for
December 21. Id.

Additionally, there are also two blank boxes in each of
these three medication sections, where nothing was
recorded, for the 3-11 shift on December 19 and the 11-7
shift on December 20. Ms. Shekell referred to these
blanks as representing that the nurse "didn't do any
monitoring or didn't initial that she had done that
particular task during that shift." Tr. 419-420.
137

Further evidence concerning the difficulty in carrying
out the 12/2/93 care plan approaches is found in the
Social Services notes. The Social Services note dated
12/17/93 indicates that the resident "apparently fell
while trying to get more robitussin." It states also
that the resident agreed that "she should request help
considering her weakened state." Lastly, the resident
requested more Pepto Bismol, but could not remember when
she had last taken it. P. Ex. 21 at 21.

Once it was ascertained that the 12/2/93 care plan
approaches could not be carried out successfully due to
resident 1's refusals and her own physical condition,
Petitioner should have developed a new care plan which
addressed fully resident 1's current needs. There is no
evidence of a care plan that mentions the problems of
resident 1's refusals and her physical inability to self-
administer medicines or addresses how to adequately
monitor her taking of medications in light of these
problems and difficulties. Petitioner's failure to
develop a new care plan on these grounds establishes
further that it violated 42 C.F.R. § 483.20(d) (1).

With respect to HCFA's claim that Petitioner didn't start
to monitor resident 1's medications (P. Ex. 21 at 31)
until December 6, four days after the 12/2/93 care plan
was written (Tr. 681), I find that this allegation goes
to the implementation of the care plan and not to the
development of a care plan. It is the latter which is
the focus of the regulation at issue here. Therefore, I
do not make any findings on this allegation.

Petitioner argues that "there is no evidence that
resident no. 1 was adversely affected because of what was
or was not in the care plan document, i.e., no evidence
of any adverse outcome." P. Resp. Br. at 21.
Petitioner's assertion fails to consider that actual harm
to a resident need not be shown to find a deficiency. As
Ms. Shekell testified, ". . . the care plan is to reflect
at all times the care needs of the patient." Tr. 699.

By leaving a misleading and inaccurate care plan in
place, thereby representing it to be accurate and up-to-
date, Petitioner potentially could have jeopardized
resident 1's health, safety, and well-being. Here,
Petitioner's difficulty in monitoring resident 1's self-
administration of medication could have resulted in the
resident "either over- or under-dos[{ing] herself." Tr.
2548 (testimony of Ms. Patience). In fact, this
potential danger did occur, for resident 1 could not
138

remember when she had last taken Pepto-Bismol.” It is
of little consequence that resident 1 may have
experienced no actual harm.

The latter part of the alleged deficiency as written in
the HCFA 2567 stated: "Medical record review revealed
inconsistencies between the assessments, RAPS, and
patient care plan indicating a lack of coordination of
information collected during the assessment process as
well as the evaluation of the care needs from the entire
interdisciplinary care team. The patient care plan must
reflect the residents care needs as reflected by the
ongoing assessment and changing needs." HCFA Ex. 2 at 9.
I find that this part of the deficiency also has been
proven by HCFA.

As I have described above, resident 1's medical chart
establishes that she had changing care needs with respect
to self-administration of medication. Her care plan
should have been consistent with any physician's orders
and should have reflected at all times her current care
needs. The fact that Petitioner did not prepare a care
plan to implement the February 1993 physician's order
contemporaneously with that order and, also, did not
develop a new care plan once it became apparent that the
care plan approaches could not be successfully carried
out, demonstrates a lack of coordination of information
and inadequate evaluation of her care needs.

To address further HCFA's claim that there were
inconsistencies among the documents, I have reviewed the
following: the medication assessment forms (discussed
above), which are dated 4/1/93 and 12/2/93; an MDS dated
8/31/93 (P. Ex. 21 at 2-5); an MDS dated 2/15/93 (P. Ex.
21 at 22-25); a quarterly review dated 11/30/93 (P. Ex.
21 at 7-8); and Social Services notes.

HCFA argued that resident 1's assessments, "as contained
in the self-medication forms and the MDS, are
inconsistent with other information in the record
regarding her confusion and forgetfulness." HCFA Resp.
Br. at 26. The Social Services notes (see P. Ex. 21 at
17-19) state that the resident exhibited yelling and
screaming on 10/4/93, 10/8/93, and 11/15/93, and, also,
manifested confusion on 10/8/93 (P. Ex. 21 at 18). The
written entry dated 11/29, in addition to mentioning the

™ Ms. Patience stated also that "there could
also be potential danger to other residents if she's
keeping the medication by the bedside and not handling it
properly." Tr. 2548.
139

resident's forgetfulness, stated also "She continues to
make most of her own decisions, but experiences a lot of
frustration over the process. [The resident] experiences
a lot of anxiety. . . and often ends up yelling at the
staff..." P. Ex. 21 at 19-20. This entry appears to
be a summary of the resident's recent behavior as
documented in the previous Social Services notes.

Nowhere on the 11/30/93 quarterly review is there any
indication that the resident had any mood or behavior
problems. P. Ex. 21 at 7-8. I realize that, in
accordance with the printed instructions on the quarterly
assessment document, the relevant time frame for purposes
of assessing resident 1's mood and behavior patterns was
the last seven days prior to the date of the quarterly
review which, in this case, would be 11/24/93 - 11/30/93.
However, in light of resident 1's recently documented
behavior of yelling, screaming, and anxiety, this
quarterly review is inconsistent with the Social Services
notes and does not appear to reflect an accurate
assessment of resident 1.”

1 The testimony elicited from Ms. Patience with

respect to F 272 is instructive:

The quarterly is just to give the facility kind
of a check to see if what they've assessed
before in the minimum data set has continued
with the resident. If it hasn't then a whole
new MDS would be indicated, and that's part of
what the quarterly is to help the facility
decide.

Q [Counsel for HCFA}: So by doing the
quarterly review, does that confine the
facility to look only at the prior seven days?

A [Ms. Patience]: .. . For the quarterly you
only look at the prior seven days. Overall,
what you've got to do is you've got to look at
the resident. If the resident is exhibiting a
change then there may be a new minimum data set
indicated, and that needs to be done if the
resident's got a significant change.

Q [Counsel for HCFA]: So, for example, if a
resident eight days or ten days prior to a
quarterly has a change in mood should that
warrant a change in the assessment?

(continued...)
140

Additionally, both the MDS dated 2/15/93 and the MDS
dated 8/31/93, indicate in Section H that resident 1 had
exhibited "verbal expressions of distress" during the
last 30 days and had demonstrated a "failure to eat or
take medications, withdrawal from self-care or leisure
activities." P. Ex. 21 at 4, 24.% This earlier
documentation of resident 1's distress, together with the
10/93 and 11/93 Social Services notes discussed above,
further support a conclusion that the accuracy of the
11/30/93 quarterly review is questionable with respect to
its assessment that resident 1 had no mood or behavior
problems.”

I find that resident 1's mood and behavior problems
should have been reflected in the 12/2/93 care plan.
Petitioner's failure to do so constitutes a further
violation of 42 C.F.R. § 483.20(d)(1). Although resident
1 was assessed as being competent to self-administer
medications according to the 12/2/93 medication
assessment, nevertheless, I find that the care plan
should have indicated her mood and behavior problems and
addressed them in the context of self-administration of
medications. The care plan was thus arguably
inconsistent with what was documented in the Social
Services notes which I discussed above. A revisiting of
the determination that resident 1 was capable of self-

7% (...continued)
A [Ms. Patience]: Depending upon how profound
the change is, yes... .

Tr. 2495-2496.

76 Pages 4 and 24 of P. Ex. 21 appear to be exact
duplicates of each other.

7 Resident 1's mood and behavior problems, as
documented in the Social Services notes, could be
described as constituting a "significant change" in her
condition that should have resulted in Petitioner
completing a new MDS some time in November 1993, at the
latest. 42 C.F.R. § 483.20(b)(4)(iv). This was not
done. If Petitioner had completed a new MDS for resident
1, such assessment would have indicated, in the
appropriate sections, the mood and behavior problems that
she had recently manifested. Furthermore, this new MDS,
may, in turn, have resulted in an entirely different
quarterly review than that which is in the record.
141

medication may have been warranted in light of the
incidents of exhibited distress. The absence of such
care plan provisions had the potential to negatively
impact this resident since, without addressing these
mental problems, the resident was prevented from
achieving her highest practicable level of mental and
psychosocial well-being. Moreover, failure to treat
these mental problems could potentially place this
resident in danger of compromising her health from either
an overdose or under dose of medication.

I. Set out below is the st nt_in e 567
concerning the alleged deficiency identified as F 297
(HCFA _Ex. 2 at 9-11):

42 C.F.R. 483.20(d)(2) (ii) Prepared by an
interdisciplinary team, that includes the
attending physician, a registered nurse with
responsibility for the resident, and other
appropriate staff in disciplines as determined
by the resident's needs, and, to the extent
practicable, the participation of the resident,
the resident's family or the resident's legal
representative;

RREKK

Based upon observation, interview and medical
record review it was determined that staff
failed to use an interdisciplinary approach to
the evaluation of resident status.

Findings include:

Resident #1 was admitted to the facility
2/1/93. In February, 1993, an order was
written by her physician that said sh [sic]
could self medicate and have her medications at
her bedside. In April, 1993, a "self
administration of medication assessment" was
completed and she was not found to be a
candidate for self-administration of
medications.

On 12/2/93 a second "self-administration of
medication assessment" was completed and signed
by a physician and a licensed nurse. She was
found to be a candidate for self administration
of medication at that time. The facility
failed to follow their own policy and procedure
"Review of bedside medications and self
administration' which requires the involvement
142

of an interdisciplinary team in the assessment,
care planning and monitoring of the resident
for self administration and bedside storage of
medication.

Cross Reference - F292

It was evident through medical record review
that all disciplines did not participate in the
evaluation and assessment of each resident on a
quarterly basis or as needed.

Cross Reference - F295

42 C.F.R. § 483.20(d) (2) (ii) pertains to the utilization
of an interdisciplinary team in the preparation of a
resident's care plan. The findings set forth in the HCFA
2567 (re-stated above) in support of this alleged
deficiency relate to resident 1's "self-administration of
medication" assessments. There is nothing in the
findings that identifies Petitioner's conduct in
contravention of the requirements of 42 C.F.R. §
483.20(d) (2) (ii), which are limited to a resident's care
plan.

The evidence offered by HCFA in the HCFA 2567 relating to
Resident 1's assessments is extraneous and goes beyond
the regulation at issue. In its brief, however, HCFA
discusses resident 1's assessments and her 12/2/93 care
plan (HCFA Resp. Br. at 29-30) although this care plan
was not mentioned at all in the findings in the HCFA
2567.

In fairness to Petitioner, HCFA's presentation of the
evidence in support of this alleged deficiency is an
example of the "moving target" approach which Petitioner
has accused HCFA of taking at times. I do not accept
HCFA's attempt to establish the existence of this
deficiency by evidence which is wholly unrelated to the
findings set forth in the HCFA 2567. Although the
regulation relates to care plans, the basis of the
deficiency, as written in the HCFA 2567, concerned
resident 1's assessments, not her care plan. While in
the course of the hearing I allowed HCFA at times to
amplify the factual elements of a deficiency, there was,
with respect to those deficiencies, sufficient
information given in the HCFA 2567 to put Petitioner on
notice of the alleged conduct being challenged which
violated the referenced regulation. Here, there are
insufficient facts in the deficiency relating to care
plans to put Petitioner on notice as to its conduct which
was out of compliance with 42 C.F.R. § 483.20(d) (2) (ii).
143

HCFA goes beyond mere amplification of the facts in the
deficiency. It introduces evidence supporting the cited
regulatory violation that was not alleged in the HCFA
2567. No amendment of the HCFA 2567 was ever sought by
HCFA. Consequently, any attempt by HCFA to go beyond

‘ what was charged in the HCFA 2567 is for naught.

Moreover, HCFA relied on the findings set forth in the
HCFA 2567, which have no relation to the language of 42
C.F.R. § 483.20(da) (2) (ii), to prove that Petitioner was
out of compliance with this regulation. This reliance is
misplaced. Resident 1's "self-administration of
medication" assessments have nothing to do with her care
Plans. Further, although F 295 cross-references F 297
(HCFA Ex. 2 at 9), the findings pertaining to F 295, set
forth in the HCFA 2567, do not support the existence of a
violation of the regulation on which F 297 is based.

The only reference to care-planning in the deficiency
related to a general allegation of Petitioner's failure
to follow its own internal procedure which requires the
involvement of an interdisciplinary team in the
assessment, care-planning, and monitoring of the resident
for self-administration and bedside storage of
medication. The deficiency fails to state with
sufficient particularity the care plan in issue, and the
make-up of the interdisciplinary team who prepared such
care plan and how that grouping was in violation of the
cited regulation. The individuals identified in the
deficiency pertained to the resident's assessment for
self-administration of medication. No information is
provided as to individuals who participated in the care
plan, nor is there a reference to a specific care plan.
Such information is basic to establishing a violation of
the cited care plan regulation.

Accordingly, Petitioner did not violate 42 C.F.R. §
483.20(d) (2) (ii).

J. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 298
(HCFA _Ex. 2 at 11):

42 C.F.R. 483.20(d) (2) (iii) Periodically
reviewed and revised by a team of qualified
persons after each assessment.

144

RaEKEK

Based on observation, staff and resident
interview, and medical record review it was
determined that the careplan did not reflect
current assessment of each resident.

Findings include:

Resident 20 was observed on 12/20/93 sitting up
in a chair. He had a Linard sitting [sic]
system in place, however he was leaning to one
side and appeared very uncomfortable. Licensed
staff reassessed the resident and changed
positional devices, and the resident told this
evaluator that he was more comfortable. The
plan of care was not updated to reflect this
change.

HCFA relies to a great extent on the testimony of Ms. Cox
for proof of this deficiency. Ms. Cox stated that she
and a staff member observed resident 20 as they walked by
him and saw that he was "in very poor bodily alignment.
He was slumped forward to the side." Tr. 1061. Ms. Cox
stated that she and the staff member "stopped and looked
at him." Id. Ms. Cox testified further:

I talked to the resident. He said -- after I
asked him if he would [sic] was comfortable in
that position which he certainly appeared not
to be, he did say that he was not comfortable.
The licensed person with me went and got either
an occupational therapist or a physical
therapist, had her come, look at him right then
when I was there. She said that the system
that they were currently using was not working
for him and that she would find something else
that did work for him.

She in fact did find something else. They
changed the chair. They used kind of an -- I'm
not sure what it's called but it's a saddle
type of thing to keep him from sliding down,
and the chair that they replaced kept him
sitting more upright.

He himself verbalized that he was more
comfortable with the new system that they had
given him. ...

Tr. 1061-1062.
145

According to Ms. Cox, Petitioner then failed to change
the resident's care plan to show that a new system had
been started with him. Tr. 1062.” Ms. Cox expressed
concern that, because Petitioner's staff left the old
care plan in place, there was a possibility that the
resident would be put back on the old system. Id.

In response to this cited deficiency, Petitioner argues
that "the evidence is in sharp dispute as to whether the
seating system was changed or whether there was only an
adjustment causing the patient to sit more upright."
Moreover, "[t]here is a failure of proof to indicate that
any modification or change which occurred required a
change in the seating system necessitating a change in
the plan of care." P. Br. at 83.

HCFA and Petitioner do not dispute that a postural
seating system was being used on resident 20 at the time
Ms. Cox observed him. This seating system, according to
resident 20's medical chart, was instituted pursuant to a
physician's order dated September 28, 1993 which states:
"Postural seating system when OOB [out of bed] for body
alignment and safety in w/c [wheelchair]. DC
[Discontinue] previous order for safety bar when in w/c .
- ." P. Ex. 23 at 4.% Petitioner's staff noted this
order in the care plan also. Id. at 12.

Although the care plan does not specify the type of
seating system used on resident 20, Ms. Cox has alleged,
and Petitioner does not appear to deny, that the seating
system which was in place for resident 20 at the time of
Ms. Cox's observation was a Linard seating system. Tr.
1308.

7% Ms. Cox stated: "When his assistive devices
for positioning were changed then his care plan was not
changed to reflect that." Tr. 1306-1307.

9 Ms. Downing testified that there was no
indication that the physician ever changed this order for
resident 20's seating system. Tr. 1916. She explained
that, in long-term care settings, seating systems are
primarily used for postural support and body alignment.
Tr. 1928.

80 Ms. Cox testified that the Linard system is "a
soft system that's shaped in a semicircle that comes up
high on the resident and fastens in front to try and keep
them from leaning to one side or the other. Help them
sit up straight." Tr. 1458. Ms. Downing testified that

(continued...)
146

I accept Ms. Cox's testimony relating to this deficiency
and find that the scenario involving resident 20 occurred
as Ms. Cox described it. Petitioner presented no
testimony from anyone on its staff who was present at the
time of Ms. Cox's observation of resident 20 to
contradict her testimony. Petitioner could have. offered
the testimony of the staff members who were directly
involved. in the reassessment of resident 20, but it did
not do so. Moreover, while Ms. Downing did testify
concerning her review of resident 20's medical chart and
about seating restraints in general, she was not present
when Ms. Cox observed resident 20 and thus has no first-
hand knowledge of this incident.”

After resident 20 voiced his discomfort, I find that
Petitioner's staff undertook significant steps to
maintain resident 20's proper posture and comfort level.
Contrary to Ms. Downing's assertion that there was no
change in resident 20's seating system, Petitioner's
staff did change positional devices to alleviate his
discomfort and help him sit upright. Petitioner's staff
removed the Linard seating system (Tr. 1308, 1310), put
resident 20 in a "saddle type of thing to keep him from
sliding down," and replaced his chair with one that "kept
him sitting more upright." Tr. 1062. Thus, it cannot be
said that resident 20's existing seating system remained
the same. I conclude that the changes made by
Petitioner's staff were significant and constituted more
than a simple re-adjustment of resident 20's existing
seating system.” As such, Petitioner's staff was

8 (...continued)
she was familiar with the Linard seating system and
stated that it is a brand of a pre-made, postural seating
system that supports a person's upper trunk. Tr. 1914.

be Ms. Downing began working for Petitioner on
January 17, 1994. Tr. 1687-1688.

2 At the hearing, both Ms. Downing and Ms.
Patience testified as to what kind of "change" in
positioning devices or seating systems would warrant
revision of the care plan. Ms. Downing testified that a
resident who was using a "seating postural support" or
any kind of restraint required periodic re-evaluation
“every two hours to make sure that. . .they're positioned
right, that the support is positioned correctly, to check
their circulation, to ensure that their posture is being
maintained." Tr. 1924. Ms. Downing stated that these
periodic re-evaluations of the resident would not

(continued...)
147

required to update resident 20's care plan
contemporaneously to reflect this change. Ms. Cox
testified that she checked the care plan between Dec. 20
and Dec. 23 to see if resident 20's care plan had been
updated to reflect the change in positioning devices, and
it had not. Tr. 1067. By its failure to revise resident
20's care plan, Petitioner did not comply with 42 C.F.R.
§ 483.20(d) (2) (iii).

In elaborating on its arguments, Petitioner contends that
the saddle is not considered to be part of a seating
system and that the addition of a saddle would not
constitute a change to the seating system per se. Tr.
1921, 2315-2316; P. Br. at 87-88; P. Resp. Br. at 23-24.
Moreover, Petitioner contends, the saddle "was added
months after the event in question and not at the time
(Ms. Cox] claimed". P. Br. at 85.8% Petitioner is
apparently referring to resident 20's plan of care, which

8% (...continued)
necessitate changing his or her care plan. Tr. 1924.

Ms. Patience, like Ms. Downing, had no first-hand
knowledge of the incident involving resident 20 which
forms the basis of this deficiency. She testified that
the readjustment of a slipped pillow or replacement of a
fallen pillow would not constitute a change in
positioning devices that would require a change in the
care plan. Tr. 2814-2816, 2818. Ms. Patience testified
also, in response to Petitioner's counsel's questioning,
that, if a resident's restraint was made to fit properly
upon becoming loosened, this would not require a change
in the care plan. Tr. 2818.

According to Ms. Patience, however, the addition or
repositioning of pillows could constitute a change which
would necessitate reporting it in the care plan if the
pillows were being used as a postural support. Tr. 2564-
2567; See also Tr. 2816. Ms. Patience, in response to my
questioning, testified, "If the pillows need to be ina
particular configuration in order to keep the resident in
a particular position, then that should be placed on the
Care Plan." Tr. 2565; See also Tr. 2566-2567.

83 Ms. Downing testified that the care plan
"doesn't show a change in the seating system", but "shows
that a western saddle was added to the seat" on 4/12/94.
Tr. 2314, 2316.
148

does indicate that a "western saddle" was added on
4/12/94 (P. Ex. 23 at 12).™

I do not agree with Petitioner that the addition of a
saddle device could not have occurred earlier, as Ms. Cox
described in her testimony. The existence of the 4/12/94
entry in the care plan does not disprove Ms. Cox's
testimony that a saddle was added to resident 20 at the
time of the survey in December 1993. It is noteworthy
that Petitioner, who had all of resident 20's medical
records in its possession, could not produce any care
plan entry dealing with seating systems that was made
contemporaneously at the time of the December 1993
survey. Petitioner produced only the April 1994 care
plan entry, which is irrelevant. Given that I find some
sort of a saddle device was added in December 1993, the
4/12/94 entry in resident 20's care plan does not negate
the failure on the part of Petitioner's staff to indicate
in the care plan in December 1993 that a saddle was
added.

Moreover, I cannot conclude whether it was a western
saddle that was used on resident 20 in December 1993.
Notwithstanding this, whether the western saddle
mentioned in the April 1994 care plan is the same device
that was used on the resident in December 1993 is
irrelevant to the issue of whether resident 20's care
plan reflected a current assessment in December 1993.

As further support that there was a change in positional
devices, as alleged in the HCFA 2567 ("Licensed staff
reassessed the resident and changed positional devices .
.- ." (emphasis added) (HCFA Ex. 2 at 11), Ms. Downing
stated that both the Linard system and the saddle could
be described as positional devices (Tr. 2315, 2316).
Thus, in light of this statement, the reference in the
HCFA 2567 to a positional device could very well be a
reference to the addition of a saddle device to resident
20, despite Petitioner's claims that no such event
occurred.

bed According to Ms. Downing, a western saddle is
not a postural seating system or a part of one. Tr.
1921. Ms. Downing described the western saddle as being
"a cushion, . . . with a saddle horn to prevent them
scooting forward. It's not considered a seating system.
. . It's designed to prevent [the individual] from
sliding out of the wheelchair." Tr. 2315; see Tr. 1921.
149

At the hearing, I pointed to the plan of correction
submitted by Petitioner in response to this alleged
deficiency and noted that it stated, in part, "The
resident's care plan has been updated to reflect
changes." HCFA Ex. 2 at 11." In response to my inquiry
as to whether resident 20's care plan had been updated to
reflect the change, Ms. Downing was unable to point to
anything in resident 20's care plan which could possibly
corroborate this statement. Instead, Ms. Downing
interpreted the statement I quoted above as referring to
a September 1993 entry in the care plan and stated
"that's what they were emphasizing." Tr. 1933-1934. I
find Ms. Downing's testimony rather puzzling and
confusing in light of the fact that this alleged
deficiency involving resident 20 occurred during the
survey in late December 1993. Any care plan change dated
prior to December 1993, while it could possibly be
considered an "update" to the care plan, would not have
any relevance to this alleged deficiency nor would it be
considered as a remedial action in response to the
deficiency. Ms. Downing's statement can be construed
only as further proof that Petitioner did not update
resident 20's care plan following the change in December
1993 in his positional devices. The statement in

85 Petitioner's plan of correction, which is
dated 1/31/94, is presumed to contain the corrective
actions it has implemented in response to the
deficiencies cited in the HCFA 2567 by the survey team.

With respect to resident 20 and this alleged deficiency,
the complete text of Petitioner's plan of correction is:

Residents shall be assessed and their care plan
approaches updated to address contracture
relative to treatment.

Resident #20 has been assessed by
interdisciplinary staff to address his needs
for proper positioning to prevent further
contracture and instructed staff in his care
needs. The residents care plan has been
updated to reflect changes.

HCFA Ex. 2 at 11.
150

Petitioner's plan of correction is apparently
uncorroborated by the record before me.*

Petitioner contends that there is no evidence to show
that resident 20's health or safety was adversely
effected. P. Resp. Br. at 24. While this may be true, I
find that there existed the potential of harm to resident
20. As I stated earlier, under OBRA, Petitioner is
responsible for providing residents with services
necessary to attain or maintain their highest practicable
physical, mental, and psychosocial well-being as required
under 42 C.F.R. § 483.25. In order to maintain resident
20's proper alignment, Petitioner's staff implemented a
significant change from his pre-existing seating system.
It was necessary for, this change to be care-planned to
ensure that other caregivers on Petitioner's staff would
know that they should implement it on a daily basis to
maintain his highest practicable physical well-being.
However, because resident 20's care plan did not indicate
the change in positional devices that occurred on
December 20, 1993, it was likely that other caregivers,
not knowing what had been done and assuming the care plan
to be up-to-date, would have put him back into his old
seating system, which had been determined to be
ineffective and uncomfortable. Such a result could have
had a detrimental effect on resident 20's health and
safety and would have contravened the very purpose of
OBRA.

The regulation requires that the comprehensive care plan
must be periodically reviewed and revised after each
assessment. This was not done here with respect to
resident 20's care plan, in violation of 42 C.F.R. §
483.20(d)(2) (iii). Moreover, such failure had the
potential to negatively impact this resident recited
above. Consequently, HCFA has met its burden of proof in
establishing this deficiency.

K. et it_below is the statement in the HCTF, 567
concerning the alleged deficiency identified as F 300
HCFA . 2 at 11-13):

42 C.F.R. 483.20(d) (3) (ii) Be provided by
qualified persons in accordance with each
resident's written plan of care.

bed Ms. Downing testified also that the care plan
indicates that there were no changes in positioning
devices until 4/12/94. Tr. 2317.
151

kK

Based on record review, observation, and
interview, the facility failed to provide
services by qualified persons in accordance
with each resident's plan of care.

Findings include:

Resident 24 has a physician's order for an E-Z
boot to be applied by nursing staff daily from
8 P.M. as tolerated. Review of his treatment
record revealed that licensed staff was
documenting that the boot was not available for
use and has not been applied since it was
ordered on 12/9/93. Licensed staff was
observed by this evaluator when they entered
the resident's room to search for the boot.

The boot was found in his bedside stand. There
was no explanation why the boot had not been
used and no monitoring system was in place to
insure the plan of care was followed.

Resident 8's plan for care dated 12/1/93
indicates that he requires 1700 CC's of fluid
over a 24 hr. period. The resident had a
diagnosis of recent pneumonia and current stage
3 decubitus. Review of the intake records from
12/2/93 to 12/19/93 revealed that the
resident's intake only met the 1700 cc goal 2
days out of the two week period. The majority
of days the resident's intake was less than
1500 cc's over a 24 hr. period and as low as
890 cc on 12/13/93 and 740 cc on 12/19/93.
Licensed nurse's notes did not address failure
to meet this resident's fluid needs, and in
fact stated there was no problem. This
resident was at high risk for further skin
breakdown and reoccurring pneumonia, if
hydration is not monitored and maintained.

1. Resident 24

According to the HCFA 2567, resident 24 had "a
physician's order for an E-Z boot to be applied by
nursing staff daily from 8 P.M. as tolerated." HCFA Ex.
2 at 12; see P. Ex. 24 at 2. Review of this resident's
treatment record revealed that Petitioner's staff
documented in this resident's record that the boot was
not available for use and had not been applied since it
was ordered on December 9, 1993. HCFA Ex. 2 at 12; see
Pp. Ex. 24 at 11, 12. The resident's treatment record
152

from December 10 through December 23, 1993, provides
notations for each day during this period indicating that
the E-Z boot was "missing" or “unavailable." P. Ex. 24
at 12. During the survey, Ms. Cox observed that 1) the
boot was found in the resident's bedside stand, 2) no
explanation was offered as to why the boot had not been
used, and 3) no monitoring system was in place to ensure
that the plan of care was followed. Tr. 1069-1070.

Ms. Cox described an E-Z boot as "a system that they use
to either prevent contracture of the ankle or sometimes
they also put them on just to protect the heels or to
keep the foot in a certain position. I've seen them used
for multiple different things." Tr. 1072. Ms. Cox
stated that failure to apply the boot as ordered could
have adverse consequences on the resident's health. Id.

Petitioner does not dispute the facts relating to the E-Z
boot cited in the deficiency, which were based on Ms.
Cox's observations.’ P. Resp. Br. at 24. Rather,
Petitioner argues that proof of a deficiency has not been
established in this record. First, Petitioner argues
that the surveyor could not state at the hearing what was
in the care plan relating to application of the E-Z boot.
Pp. Br. at 90. Second, the plan of care is not in the
record and there is no evidence that it covered use of an
E-Z2 boot. P. Resp. Br. at 24-25. Third, Petitioner
contends that failure to follow a physician's order is
not violative of the cited regulation since the
regulation pertains to care plans. Id. at 25. Fourth,
Petitioner argues that, even if a deficiency could be
found, it was corrected before completion of the survey
and, as a result, no deficiency should have been cited.
P. Br. at 89. Last, Petitioner argues that HCFA has
shown no pattern or negative outcome to the resident. P.
Resp. Br. at 25.

I agree with Petitioner that 42 C.F.R. § 483.20(d) (3) (ii)
relates to failure to provide services in accordance with
the resident's plan of care. HCFA did not place in
evidence a plan of care which implements the physician's
order requiring use of the E-Z boot. However, such
absence does not amount to a failure of proof. While Ms.
Cox could not recall at the hearing what the plan of care
said about application of the E-2 boot, she did testify
that she reviewed the care plan in connection with
preparation of her findings.

This deficiency was written because I did a
record review. I observed the resident and I
interviewed facility staff and when all after I
had looked at the record and the Care Plan
153

{emphasis added) and I asked facility staff --
When I observed him he didn't have his easy
{sic} boot on as it was ordered by the

physician or as it was Care Planned [emphasis
added}, . . .{she went on to describe the
undisputed facts in this deficiency.) ... So

obviously they didn't follow their plan of care
and nobody was familiar with the fact that the
boot was right in his closet... .

Tr. 1069-1070.

Besides such testimony, my review of this resident's
records, including the minimum data set, quarterly
review, rehabilitation screen and physician's order,
leads me to conclude that a care plan was developed for
this resident which carried out the physician's order for
application of the E-Z boot. P. Ex. 24. These documents
establish that the resident had contracture of his lower
extremities which would necessitate treatment and which
would have triggered preparation of a plan of care which
would have included the physician's order for application
of the E-Z boot. Id. at 2-4, 6, 9.

Even without the presence of the care plan in evidence,
there is sufficient evidence to create a strong inference
that such plan existed and was relied on by Ms. Cox in
preparing her findings. While Petitioner's counsel may
have shown that Ms. Cox had no recollection of the
specifics of the care plan at the hearing (Tr. 1327),
such failure of recollection does not negate the weight
of other evidence in the record suggesting the existence
of the care plan and that it implemented the physician's
order relating to use of the E-2 boot on this resident.
Moreover, I do agree with HCFA's position that, if
Petitioner contends that the care plan did not cover the
E-Z boot, it should have put the care plan in evidence.”
HCFA Resp. Br. 35-36. No such care plan was submitted by
Petitioner. Therefore, based on the record as a whole, I
find that Petitioner failed to carry out the physician's
order in accordance with the resident's care plan. This

87 I have concluded that HCFA has sufficient
evidence of record to support a strong inference of the
existence of a care plan which included the physician's
order for the E-Z boot. Once such inference is
established, Petitioner, who is in possession of the
medical records for this resident, has the burden of
refuting the inference by offering the care plan into
evidence.
154

failure is precisely the type of conduct that the cited
regulation was promulgated to cover.

Petitioner argues that even assuming the regulation was
violated, the deficiency was corrected prior to
completion of the survey. I do not agree. The violation
goes beyond mere placing of the E-Z boot on the resident;
it includes also the absence of a monitoring system to
ensure that the care plan was followed. See HCFA Ex. 2
at 12; Tr. 2584-2585. Arguably, the failure to have a
monitoring system in place led to Petitioner's failure to
locate the E-Z boot until the surveyor directed the
attention of the staff to its absence. This conclusion
is supported by the nurses' treatment notes indicating
that, from December 10 through December 21, 1993, the E-Z
boot was either missing or unavailable. P. Ex. 24 at 12.
It appears that Petitioner's staff did nothing to locate
the missing boot nor take steps to get a new boot. fr.
1069-1070; P. Ex. 24 at 11-12.

Petitioner has not contended nor can I find in this
record any evidence that a monitoring system was in place
or put in place at the time of the completion of the
survey. Without such a system in place, there is no
assurance that the circumstances of this deficiency would
not be repeated with other residents. Thus, I cannot
find that this deficiency was corrected at the completion
of the survey.

Lastly, Petitioner argues that there is no evidence of a
pattern or negative outcome resulting from this
deficiency. Again, I do not agree. The lack of a
monitoring system placed this resident and other
residents at risk that their treatment would not be
provided as ordered by their physicians and implemented
in their care plans. The absence of such system goes
beyond the treatment of a single resident. The potential
for a negative outcome to the health and safety of the
residents of Petitioner due to failure to provided
necessary treatment cannot be seriously disputed. Such
an outcome is contrary to the tenets of OBRA '87 and its
implementing regulations.

2. Resident 8

Resident 8's plan of care indicated that he was at risk
for fluid volume deficit. P. Ex. 25 at 5. His care plan
stated (in the column titled "Measurable and Time
Oriented Objectives") that he will have moist oral mucosa
and his fluid intake will be at least [emphasis added]
1700 cc's of fluid over a 24-hour period. Id. The
resident had been diagnosed with recent pneumonia and
155

current stage 3 decubitus (pressure sores). HCFA Ex. 2
at 12. The care plan approaches to achieving the goal of
1700 cc's of fluid was to “encourage fluids" and monitor
the resident's intake and output. Also, Petitioner's
staff was to "[a]ssess for dry oral mucosa & notify MD
immediately if present. Monitor labs as ordered."* p.
Ex. 25 at 5. A surveyor's review of the resident's
intake records from December 2 to December 19, 1993
indicated that the resident's intake was 1700 cc's on two
days out of this two-week period.® HCFA Ex. 2 at 12.

HCFA argues that

» + . Petitioner's continuing failure to follow its
care plan for the resident's fluid intake when the
amount of fluid being consumed continued to fall far
below the established goal, or to change the plan if
necessary, demonstrates a lack of concern and
attention to the resident's physical well-being,
clearly in contravention of OBRA and its
regulations. HCFA Br. at 37.

In response, Petitioner argues that the HCFA 2567 implies
that there was a failure to follow the requirements of a
plan of care for 1700 ccs of fluid intake. Petitioner
contends that "[t]he care plan document itself does not
show any such requirement but shows this to be a goal or
objective." P. Br. at 93. Further, Petitioner asserts:

[t]he intake and output records indisputably show
that the care plan was followed with respect to the
monitoring requirement of the care plan. HCFA
failed to put on any proof that the facility did not
encourage the fluids as required by the care plan.
There is accordingly no evidence indicating a
failure to follow the care plan which, contrary to
the evidence, did not require that 1700 ccs be
achieved in a 24-hour period.

P. Br. at 92.

8% There was no evidence offered by HCFA or
Petitioner on this lab monitoring action set forth in the
care plan. Accordingly, I can make no findings on
whether this aspect of the care plan was met.

8 By actual count, it is an 18 day period,
approximately two and one half weeks.
156

Petitioner takes exception also to the statement in the
HCFA 2567 alleging "[1ljicensed nurse's notes did not
address failure to meet this resident's fluid needs, and
in fact stated there was no problem." Petitioner argues
that "the allegation that the nurses' notes did not
reflect the failure to take in 1700 ccs of fluid is not a
violation of the regulation, which requires that care be
given in accordance with the written plan of care." P.
Br. at 92.

I cannot accept Petitioner's interpretation of this
resident's care plan regarding the intake of 1700 ccs of
fluid daily. The plain meaning of the care plan --
"fluid intake will be at least 1700 cc/24 hr" -- leaves
no doubt that 1700 ccs was the minimum amount of fluid
that this resident was to be provided within a 24-hour
period. The language is clearly mandatory and not
permissive. Even if the 1700 cc amount can be
characterized as a goal, the care plan makes clear that
this objective was to be met each day.

The record is unambiguous as to Petitioner's failure to
have this resident meet this 1700 cc objective on a daily
basis as called for in the care plan. During the period
of December 2 through December 19, 1993, the resident met
the objective only on December 2 and 17, 1993. P. Ex. 25
at 2-4. Although the resident met the objective only
once during the period of December 2-8, 1993, there is no
notation on his Intake and Outpatient Record that any
evaluation of the resident or monitoring of his intake
was conducted. Id. at 2. Records for December 9-19,
1993 reflect that the resident met the objective only
once and his average 24-hour intake was 1182 ccs for 12/9
- 12/12/93 and 1278 cc's for 12/13 - 12/19/93. Id. at 3-
4. These records indicate that Petitioner's staff
encouraged the resident to increase his fluid intake and
praised him for his efforts. Id. His mucous membrane
was noted to be moist. Id.

Ms. Patience testified that "it's a deficient practice if
the goal is to be 1700 cc's and they weren't meeting it,
that's a deficient practice." She stated also that the
goals should have been either updated or reassessed and
the care plan should have been revised. Tr. 2590-2591.

I conclude that Petitioner failed to treat resident 8 in
accordance with his written plan of care and thereby
violated 42 C.F.R. § 483.20(d)(3)(ii). Resident 8's care
plan specifically provided that he should have at least
1700 cc's of fluid over a 24-hour period. The evidence
shows that the resident did not receive the 1700 cc's of
157

fluid except for two days out of the 18-day period
covered in the record.

Petitioner's argument that "there was no adverse impact
to the patient's state of hydration or his health, and
the amount actually consumed was adequate for his
condition" is flawed. P. Resp. Br. at 91. I have no
information on this resident's status for the first week
since Petitioner's staff failed to complete its own
evaluation form. P. Ex. 25 at 2. I would agree that, if
a measuring criteria for lack of hydration is a dry oral
mucosa as suggested by the care plan, there is no
evidence that this occurred during the period December 9
- 19, 1993." Id. at 3-4. However, I find credible the
testimony of Ms. Cox and Ms. Patience that reduction of
this resident's fluid intake below the care plan
objective could have placed him at risk for pneumonia and
skin breakdown. Tr. 1078, 2588-2589. While the resident
may have had a moist mucosa, continued repeated failure
to adhere to the 1700 cc objective eventually could have
placed his health and safety at risk.

I do concur with Petitioner's position that its staff
monitored the resident's fluid intake and output. P. Br.
at 92. The Intake and Output Records in evidence support
this view. P. Ex. 25 at 2-4. But monitoring is not
enough. The care plan indicated that the resident was to
receive at least 1700 cc's of fluid each day. Petitioner
did not ensure that this mandated objective in the care
plan was met. Nor did Petitioner's staff's use of
encouragement meet this requirement. Id. I do not
accept Petitioner's reasoning that monitoring this
resident's fluid intake and output and encouraging his
increase intake can be substituted for following the
specific intake objective contained in the plan of care.

I agree with HCFA's contention that Petitioner was
required to take action and reassess the resident where
the stated fluid intake objective in the care plan was
not achieved except for two isolated days. HCFA Resp.
Br. at 37. Notification of the physician would be
necessary even when no specific adverse impact on the
resident was noted, such as a dry mucosa. I must assume
that the physician chose the 1700 cc intake objective for
some medically justifiable reason. By not giving the
resident the stated amount on a regular basis, Petitioner
was in effect altering the specific intake objective in

* The resident's skin turgor was noted to be "warm
& dry" or "good," no edema was noted and his mucous
membrane was noted to be moist. P. Ex. 25 at 3-4.
158

the care plan. Considering the potential for adverse
consequences resulting from lack of fluids, Petitioner
would need to advise the physician of the lower fluid
intake and inquire whether the care plan needed to be
amended to correspond to the fluid level that the
resident was consuming. Despite the fact that Petitioner
failed to change the resident's care plan in this case,
such failure cannot be a basis for a deficiency, since it
is outside of the parameters of the cited regulation.”

L. se t below the stateme: in the HCFA
oncerni the alleged deficienc entified a: 9
(HCFA Ex. 2 at 13-14):

42 C.F.R. 483.25. Each 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.

RRAKK

Based on record review, observation, and
interview the facility failed to provide the
necessary care and services to attain or
maintain the highest practicable physical,
mental and psychosocial well being of each
resident.

Findings include:

Resident 20 was observed eating lunch in his
room, in bed. He was attempting to feed
himself. Each time he lifted a spoon full of
food to his mouth he tipped the spoon, dropping
most of the food onto his lap or back onto the
plate. Review of the medical record revealed
that he has a diagnosis of a stroke with
hemiparesis and diabetes. The nursing
assessment indicates that he leaves 25% or more
of his food and requires supervision while
eating. He is below his ideal body weight.
This resident was not properly supervised and
assessment for the use of assistive devices was
inadequate.

‘| There is no indication in the HCFA 2567 that the
facts of this deficiency were to be cross-referenced to
another citation, such as F 298, that pertains to the
need to revise assessments.
159

Review of resident 16's medical record revealed
that she was making good progress in her
ability to ambulate in June 1993, as documented
by Physical Therapy staff. She was referred to
the restorative nurse aide program for
continued ambulation. She was discontinued
from the program for no stated reason and
currently is on no routine ambulation program.
Observation of this resident throughout the
survey revealed that she spends most of her day
restrained with a vest in a wheelchair.

Cross reference F292.

1. Resident 20

Resident 20 was admitted to the facility on March 30,
1993. P. Ex. 26 at 1. An April 1, 1993 entry in
Resident 20's care plan, in the column titled "Patient
Problems/Needs" states "Alteration in nutritional needs
due to: Dx: DM [diabetes mellitus], CVA [cerebralvascular
accident) c Rt. hemiparesis, low wt. c wt. loss" and
notes that his ideal body weight range is 133 to 163
pounds. Tr. 229-231; P. Ex. 26 at 10. Resident 20's
weight upon admission was 108.4 pounds, well below his
ideal weight. P. Ex. 26 at 10. The record indicates
that Resident 20 also had Parkinson's disease and
difficulty in swallowing (dysphagia).” P. Ex. 26 at 1,
10. It is apparent from the record that all of this
information was known to Petitioner when it admitted
Resident 20. Id.

Resident 20 continued to lose weight during his stay. P.
Ex. 26. HCFA contends that resident 20 was attempting to
feed himself and was unable to manage the eating utensil,
dropping the food onto his lap or onto the plate. HCFA

Br. at 59. HCFA contends further that "the resident was

2 he transcript contains a reference defining
Gysphasia as difficulty in swallowing. Tr. 231.
However, the definition of dysphasia is "loss of or
deficiency in the power to use or understand language as
a result of injury to or disease of the brain".
Webster's Ninth New Collegiate Dictionary 391 (9th ed.
1990). The word dysphagia is defined as "difficulty in
swallowing." Id. Since the witness testifying defined
the word as meaning difficulty in swallowing, I can only
conclude that the transcript reference at Tr. 231 should
read dysphagia and not dysphasia. The rehabilitation
screen confirms this conclusion, for, in the "feeding"
section, there is a box checked indicating resident 20
had dysphagia. P. Ex. 26 at 3.

160

not properly supervised and assessment for the use of
assistive eating devices was inadequate." HCFA Br. at
60. HCFA argues that Petitioner failed to provide
resident 20 with the necessary care and services such
that he could maintain adequate feeding. HCFA Br. at 63.

Ms. Shekell testified that from December 16, 1993 through
December 31, 1993, resident 20 was assessed by Petitioner
as being able to eat independently. Tr. 232; P. Ex. 26
at 13. However, out of the total of 48 meals that were
received by resident 20 during this time period, he
consumed 75 percent or less on 34 occasions out of the
48. P. Ex. 26 at 13; see Tr. 232-233. Moreover, Ms.
Shekell stated that, according to the minimum data set
dated 4/12/93, it appears that resident 20 was initially
assessed as a "4" (total dependence) in the "Eating"
subsection of section E, but the "4" was subsequently
crossed out and replaced with a "0", indicating that he
was independent. Tr. 233-234; see P. Ex. 26 at 5.
Quarterly reviews dated July 14 and October 12, 1993
indicate that resident 20 was able to eat independently
without help or supervision. Tr. 234-235; P. Ex. 26 at
8. However, Ms. Shekell testified, the assessments are
at odds with other parts of resident 20's record, which
indicate that he had impaired range of motion and
impaired strength in his upper extremity; was prone to
contractures; had motor, memory, and sensory deficits;
had impaired cognitive status; and also had Parkinson's
disease. Tr. 235-236; see P. Ex. 26 at 3. Ms. Shekell,
after describing resident 20's impairments, stated "and
yet [resident 20] was allowed to feed himself." Tr. 236.

Petitioner contends that resident 20 "was maintained at
his highest practicable level" because he was given a
special spoon to assist him in eating independently. P.
Br. at 97; see id. at 102. Petitioner contends that
resident 20 was offered other nourishment but frequently
refused it and that he also refused to eat at all ona
number of occasions. Jd. at 97, 103. Petitioner notes
further that resident 20 rejected more stringent
measures, such as tube feedings. Id. at 97, 101, 103.
Accordingly, Petitioner contends there were no other
alternatives by which it could have given more nutrition
to resident 20 and, "given his abilities and his state of
willingness to take nourishment," it did maintain the
resident at his highest practicable level. Id. at 97,
103.

contrary to Petitioner's position that no other methods
could have been used to assist resident 20 with his
eating, the testimony from Ms. Shekell and Ms. Patience
is that other assistive devices could have been tried to
161

assist resident 20 to consume larger amounts at his meal
times. Additionally, HCFA avers that Petitioner's staff
could have encouraged resident 20 in his efforts. HCFA
Br. at 64.

While there is some evidence that resident 20 was offered
additional nourishment, the record as a whole reflects
that resident 20 was attempting to eat his meals
independently, but was unable to do so and was unable to
consume sufficient nourishment with the assistance that
was being provided by Petitioner. P. Ex. 26; Tr. 233-
236. There is no evidence that resident 20 was ever
reassessed or that his care plan was adjusted in light of
the difficulties he was having in consuming sufficient
nourishment. P. Ex. 26.

Petitioner thus failed to maintain resident 20 at his
highest practicable level because it failed to address
the problems he was experiencing in consuming sufficient
nourishment. It would be one thing if Petitioner had
tried additional methods and none of these worked.
However, the only methods attempted by Petitioner to
assist resident 20 were providing him with a special
spoon and offering him additional nourishment. The
record reflects that both of these methods were
ineffective, as resident 20 was observed as not being
able to eat independently and was not amenable to
accepting the additional nourishment offered by
Petitioner. The uncontradicted testimony is that other
methods could have been attempted to assist him, but were
not. My finding is not that, when a facility encounters
a resident who has difficulty eating independently, the
facility must exhaustively attempt every conceivable
method to get the resident to eat. The facts are that
resident 20 was having a large amount of difficulty in
consuming sufficient nourishment to maintain his health.
The record reflects that Petitioner's approach to solving
resident 20's difficulty in eating adequately was to
provide him with a special spoon and that this was not
working, as the surveyor observed. Also, the chart
reflects that he dropped much of his food. It is
apparent that Petitioner could have tried other methods,
short of tube feeding or force feeding, to enable
resident 20 to eat more. Petitioner failed to do so.
Accordingly, Petitioner failed to provide resident 20
with the care necessary to maintain or attain his highest
162

practicable well-being, in violation of 42 C.F.R. §
483.25.%

2. Resident 16

HCFA contends that the deficiency with respect to
resident 16 "involves Petitioner's failure to maintain
(her) . . . at her highest practicable level of
ambulation following her discharge from the restorative
nurse aide (RNA) program." HCFA Resp. Br. at 40-41.
According. to HCFA, resident 16's medical record indicates
that she was placed in the RNA program for ambulation in
June 1993 and that, during June and July 1993, she made
significant progress in her ambulation. HCFA Resp. Br.
at 41; see P. Ex. 27 at 13-15 (relevant part of medical
record). HCFA states that, with no documented reason,
the resident was discontinued from the program on August
9, 1993, and that the progress notes stated that staff
would continue to ambulate her. HCFA Br. at 66. HCFA
contends that, at the time of the survey, there was no
evidence that the resident was being routinely ambulated.
Id. at 68; HCFA Resp. Br. at 41-42. Further, HCFA notes
that the surveyor observed that resident 16 was
restrained with a vest in a wheelchair. HCFA Br. at 65.

Petitioner contends that, contrary to HCFA's allegations,
resident 16's medical chart indicates that she was
routinely ambulated following the conclusion of the RNA
program. P. Br. at 103-110. Petitioner alleges that
"([t)here is no evidence that her ability to ambulate
declined in the slightest." P. Br. at 25. Petitioner
contends further that resident 16 "was maintained at the
highest practicable physical level with respect to her
ability to ambulate." P. Br. at 104.

I find that the record supports Petitioner's position
with regard to the ambulation of resident 16. The
testimony of HCFA's witnesses on this issue is
conflicting and unpersuasive. The record reflects that
resident 16 began the RNA ambulation program on June 15,
1993, and that the initial program was for her to
ambulate with a front wheel walker 20 feet to 60 feet
with the limited assistance of two persons, as tolerated,
seven times a week. P. Ex. 27 at 13-14; Tr. 1091-1092.
The record further indicates that resident 16 was
ambulating from 60 to 100 feet during the period June 15
- June 30, 1993, and from 80 to 100 feet during the

% This resident is now deceased. I have no
information which suggests this resident's death was
related to the circumstances of this deficiency.
163

period July 1 - July 31, 1993. P. Ex. 27 at 13, 15. On
August 9, 1993, the resident was discontinued from the
program. P. Ex. 27 at 17-18. The 8/9/93 progress notes
stated "D/C from RNA program . . .able to ambulate 70 ft.
this distance can tolerate. Resident made progress
toward the program. CNA [certified nurse's assistant]
will cont. to ambulate the resident during care." P. Ex.
27 at 18.

On cross-examination, Petitioner's counsel questioned the
surveyor regarding certain nurse assistant records (P.
Ex. 1 at 14-17) in resident 16's chart. Upon examining
these records, the surveyor, who had previously testified
that there was no evidence in the chart that resident
16's ambulation continued following the conclusion of the
RNA program, conceded that they indicated that resident
16 was ambulated daily throughout November and December
1993. Tr. 1517-1523. Specifically, the November 1993
nurse assistant records contain notations which indicate
that resident 16 was ambulated daily, with assistance or
a walker. P. Ex. 1 at 14-15. On two occasions, resident
16 ambulated independently. P. Ex. 1 at 15. The
December 1993 nurse assistant records also show that
resident 16 ambulated daily, either with assistance or a
walker. P. Ex. 1 at 16-17.%

Absent HCFA establishing that Petitioner's records on
this issue were either erroneous or altered in some way
to reflect an activity which did not occur, HCFA has
failed to meet its burden of proof on this deficiency
concerning resident 16's ambulation. HCFA has offered
nothing to contradict the evidence in resident 16's
records. I find that, contrary to HCFA's allegations,
the records reflect that resident 16 was ambulated
routinely following the conclusion of the RNA program.

The following testimony is noteworthy:

Judge Steinman: In light of what
counsel just showed you, in terms of
these charts, do they reflect a
routine ambulation program, or were
you referring to something else?

Witness: I don't know. According to
what he just showed me, they would
infer that the resident was being
ambulate(d]; you're correct. ...

Tr. 1530.
164

Additionally, HCFA has offered nothing more than an
unsubstantiated allegation that resident 16's ambulation
declined. I realize that, while Petitioner's records do
establish that resident 16 was ambulated, they are not
illuminative regarding the actual distance that resident
16 was ambulated. P. Exs. 1, 27. However, HCFA has not
offered anything from which I can conclude that resident
16 was not ambulated such that she was not maintained at
her highest practicable level. Moreover, the testimony
of the surveyor on this issue was unpersuasive. When
pressed on the issue of how it was that she was aware
that resident 16's ambulation had declined, the surveyor
could only speculate. Tr. 1528-1529.

HCFA argues further that resident 16's care plan did not
contain any goals regarding ambulation and that
Petitioner should have documented daily the frequency and
distances of resident 16's ambulation so that it could be
assessed whether the resident was maintaining her highest
ambulation level. HCFA Resp. Br. at 41-43. Because I
find that Petitioner was not deficient with regard to
maintaining the ambulation of resident 16 at its highest
practicable level, I do not address these issues.

M. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 320
(HCFA Ex. 2 at 14-15):

42 C.F.R. 483.25(c)(2) (2) A resident having
pressure sores receives necessary treatment and
services to promote healing, prevent infection
and prevent new sores from developing.

kkRKK

Based upon observation, interview and medical
record review it was determined staff failed to
provides [sic] services and treatment to
prevent development of decubitus and promote
healing.

Findings include:

During observation of residents with decubitus
and review of records it was noted
approximately 35 pressure sores had developed
within the facility, indicating a lack of
identifying residents prone to skin breakdown,
early identification, and inadequate treatment.
165

Resident 31 had an order for a Tegaderm
dressing to be in place at all times. On 12-
22-93 prior to observation of a treatment and
change of dressing it was noted that the
tegaderm was not in place. Other open areas to
be treated did not have dressings in place as
ordered by the physician. The treatment sheet
indicated the dressings were in place and
checked for proper placement. Residents with
skin problems were noted to have poor
inadequate positioning devices to alleviate
pressure to the affected area.

Resident 31's medical record indicates that the dressing
was to be changed twice a day. The physician's order
dated December 1, 1993 states "cleanse open area coccyx
(with] nss [normal saline solution], pat dry and apply
Carrington gel and cover [with] Tegaderm dressing BID
[twice a day] till clean then d/c [discontinue]." P. Ex.
28 at 17.

Ms. Patience indicated that, in this instance, the
purpose of the Tegaderm dressing was to act as a barrier
to protect the wound from outside bacteria, as well as to
keep the gel in place. Tr. 2620-2621. Ms. Patience
explained the consequences to a resident if the Tegaderm
were to come off:

[t]he gel might not stay in place and might leak out
of the wound. And, there also is opportunity for
infection because of the bacteria. There also could
be further skin breakdown because of any contact it
may -- the wound may have with the bedding and the
bed.

Tr. 2621.

Ms. Patience stated that, in a situation like this, the
physician's order would require that the Tegaderm be in
place at all times. Tr. 2621.

Further, with regard to resident 31, Ms. Shekell
testified:

I went in to watch the [staff] person change a
dressing on a resident and the resident had a
physician's order for Tegaderm which is an adhesive-
type covering, dressing, to cover the area and when
I went in on 12-22 to observe this treatment and
change of dressing it was noted that the Tegaderm
was not in its place. There was [sic] additional
open areas on the patient and they did not have
166

dressings as was ordered by the physician. I then

went to the treatment record and it indicated that

the dressings were in place and had been checked on
the previous shift for proper placement.

Tr. 241.

In response to this deficiency, Petitioner argues the
following: (1) "there was no evidence of any failure to
apply the Tegaderm dressing twice a day," which is all
the physician ordered; (2) “assuming there was a failure
to comply with the physician's order," the noncompliance
was a single instance which was immediately corrected;
and (3) the resident's medical record showed that the
"pressure sore improved from a stage 3 to a stage 1." P.
Br. at 112.

Petitioner's argument that it followed the physician's
order to the letter with regard to this resident and that
there was no evidence to indicate that it did not apply
the Tegaderm twice a day suggests that Petitioner does
not understand that merely following a physician's order
is not enough. One of the purposes of the Tegaderm is to
protect the Carrington gel from oozing out. Without the
Tegaderm, the resident is subject to infection from
bacteria coming into contact with the pressure sores.
This resident had more than one Tegaderm dressing missing
which put her at a greater risk for bacterial infection.
Even if the medical record indicated that the previous
shift had noted that the Tegaderm dressings were in
place, Petitioner is responsible for checking on the
resident's condition to see that she was not
unnecessarily put at risk by the slippage of the Tegaderm
dressing. The surveyor observed that the dressings were
not in place. The surveyor's observation regarding the
treatment of this resident's pressure sores indicates
that Petitioner's staff may not have been accurately
recording in the treatment records the application of the
required treatment. Here, again, Petitioner could easily
have substantiated the accuracy. I conclude that
Petitioner violated 42 C.F.R. § 483.25(c) (2) with respect
to the treatment of resident 31.

Finally, assuming arguendo that resident 31's "pressure
sore improved from a stage 3 to a stage 1" (P. Br. at
112), I have no way of knowing if all of resident 31's
pressure sores improved or worsened, nor do I know to
what extent, if any, this resident was at risk for
bacterial infection to other pressure sores. With
respect to the HCFA 2567's mention that "approximately 35
pressure sores had developed within the facility" (HCFA
Ex. 2 at 15), the record is silent as to how many
167

residents had pressure sores. HCFA has failed to prove
this aspect of the deficiency as set forth in the HCFA
2567.

N. Set out below is the statement in the HCFA 2567

concerning the alleged deficiency identified as F 324
. it - H

42 C.F.R. 483.25(e)(2) (2) A resident with a
limited range of motion receives appropriate
treatment and services to increase range of
motion and/or to prevent further decrease in
range of motion.

RRKKK

Based on observation, interview and record
review it was determined that staff failed to
provide appropriate treatment to increase
and/or prevent further decrease in range of
motion.

Findings include:

Resident 2 was noted to have as [sic] left hand
and arm splint in place. It was noted that the
splint was not properly applied to benefit the
resident and prevent further decrease in range
of motion. Other residents observed in the
hallway were observed to have adaptive devices
which were not placed properly to provide
therapeutic treatment.

HCFA admits, in effect, that the surveyor mistakenly
designated resident 2 as the subject. HCFA Br. at 72.
However, HCFA proposes that "based on other findings
already discussed at length herein, such as the failure
to properly position the gentleman found sitting in the
Linard seating system, and the failure to apply the E-2
boot as ordered for the resident who suffered from foot
drop, it is submitted that this deficiency has been amply
supported by the record, and that adaptive devices were
often not placed properly, or even at all, to provide the
therapeutic treatment for which they were intended." Id.

There was no oral or documentary evidence presented on
this alleged deficiency. Since the HCFA 2567 incorrectly
identifies resident 2 as the subject of this deficiency,
I find that HCFA has not met its burden of proof here. I
must agree with Petitioner that, absent the designation
of a specific resident as the subject of this deficiency,
I do not have a sufficient basis to conclude that "other
168

residents" were subject also to adaptive devices which
were improperly placed. It is not enough for HCFA to
offer examples of residents who were discussed in other
deficiencies to corroborate the allegations in this
deficiency. I might consider evidence of other
deficiencies if the deficiency in question had cross
references (see HCFA Ex. 2 at 5, 6, 9, 10-11, 14 for
citations to deficiencies which cross reference other
deficiencies in the HCFA 2567), but there are no cross
references cited here. To conclude that I can look to
other evidence to support this deficiency would be
violative of Petitioner's due process rights since HCFA
never identified the resident who is the subject of the
deficiency. Thus, Petitioner had no opportunity to
defend against this alleged deficiency.

I conclude that HCFA failed to prove that Petitioner was
in violation of 42 C.F.R. § 483.25(e) (2).

0. Set out below is the statement in the HCFA 2567

concerning the alleged deficiency identified as F 373

HC. Ex. 2 at 16-17):

42 C.F.R. 483.35(f)(3) (3) The facility must
offer snacks at bedtime daily.

KKK

Based on interview of residents and staff, the
facility failed to offer snacks at bedtime
daily.

Findings include:

Two of four residents interviewed by this
evaluator stated that they were [not]” offered
snacks at bedtime. Both stated that they would
like to have snacks. Licensed staff
interviewed on one station stated that
residents only get snacks if they have a
physician's order, or if they request it. :
Resident[s] are not offered snacks on a routine
basis. The medical record of one resident
documents no snacks were given, while the other
has only intermittent snacks documented.

ia According to Ms. Cox, who prepared these
findings, she inadvertently left out the word "not". Tr.
1102. Petitioner does not challenge this explanation and
assumed that was the surveyor's intention. P. Br. at
121.
169

HCFA relies on the testimony of Ms. Cox for proof of this
deficiency:

I interviewed four residents, and two of the
residents stated to me when I asked them about
dietary problems or about their meals, ...
that they were not offered snacks at bedtime.
« « . ([T)hey both stated that they would like
to have snacks and they were not getting them,
and I talked to the licensed nurse at the
station and she said that the residents only
get snacks if they have a specific physician's
order or if they request it daily[.]...
[T]he resident[{s} should not have to request
[snacks] daily because the regulation reads
that they must be offered snacks at bedtime
daily, and they [i.e. the residents] were
deemed interviewable by the facility itself,
and so when you're interviewing interviewable
residents that the facility says, yes, you
know, they understand what you're going to say
to them; they participate in their daily care,
then I have to take their word for the fact
that they were not offered snacks daily and
that they would like to have . .. [them].

Tr. 1103.

Petitioner makes several arguments in response to the
cited deficiency. First, the two residents surveyed who
indicated a failure to receive bedtime snacks represented
an isolated circumstance -- two residents out of a
resident population of 234. P. Br. at 121. Second,
Petitioner had a policy of offering snacks at bedtime and
forms existed in each resident's record which could
verify that they were offered such snacks. Id. at 122.
Third, Ms. Cox testified that she never consulted these
resident records in preparing the deficiency. Id. at
123. And last, because Ms. Cox could not identify the
residents who she interviewed for this deficiency, Ms.
Downing reviewed resident records for all of the
identified residents who were listed on the survey team's
resident roster (P. Ex. 50) and determined that all
residents except for those on tube feeding were offered
snacks at bedtime. Id. 123-124.

Ms. Cox had no recollection of the identities of the two
residents, although she did examine their resident
records which reflected no snacks given to one resident
and only intermittent snacks given to the other. fr.
1366, 1368-1371. However, inasmuch as Ms. Cox could not
identify the residents, I find her statement regarding
170

review of their resident records to be without probative
value.

I did review P. Ex. 30 which, according to Ms. Downing,
is a compilation of the December 1993 monthly flow sheets
for all the residents listed on the sample resident
roster used by the surveyors in selecting residents for
interviews. Tr. 2039. However, I did not reach the same
conclusion as Ms. Downing that all residents except for
those on tube feedings were offered snacks at bedtime. I
do agree with HCFA's counsel's observation that the
notations on the monthly flow sheets contained in P. Ex.
30 are at times inconsistent and confusing.” HCFA Resp.
Br. at 46. In the applicable block for "HS nourishment
offered"”, some blocks have checks (P. Ex. 30 at 1-2, 5-
6, 8-10, 12, 19-20, 32-34, 45-49, 55-56, 58, 69, 71-72);
some have "y" marks (id. at 3-4, 24, 65-66, 70); some
have "no" (ia. at 10)"; some have "NA"® (id. at 11'”,
14-15, 16!) 2213, 23! 28105 37-38, 40-4117,

% Ms. Downing, in response to my inquiries as to

the meanings of the different markings in the blocks on
the flow sheets, admitted "[t]hat's why we all have
problems with these when we -- we need to be working with
the staff to understand what they are. And part of our
revision of the forms is to attempt the consistent method
of interpreting these." Tr. 2050.

” Ms. Cox testified that "HS" means hour of
sleep which in the context of this form means at bedtime.
Tr. 1375.

% There is no indication of tube feeding of this
patient.

ad Without a further explanation, I assume "NA"
means not applicable.

100 This resident has "NA", "N" and checks in the
various blocks for the month of December 1993. See P.
Ex. 30 at 11-12. Again, there is no indication of tube
feeding.

to This resident apparently was receiving tube
feeding for the month of December 1993. This can be
discerned from the "GT" notations in meal blocks on the
flow sheets. See Tr. 2045.

10 There is no indication that this resident was
receiving tube feeding. P. Ex. 30 at 17.
171

60', 62%); some have the letter "N"9 (ja. at 11!,
1g'?, 2113, 2314, 25-2615); some have dashes!!® (id.

18 (...continued)
108 There is no indication that this resident was
receiving tube feeding.

104 There is no indication of tube feeding.
105 There is no indication of tube feeding.
106 There is an indication that this resident was

being fed by staff and receiving double portions during
December 1993. P. Ex. 30 at 39. There is nothing to
suggest that a snack was contraindicated for this
resident.

107 This resident apparently was on regular puree
diet and had the ability to feed herself. P. Ex. 30 at
40-42. There is no reason in the record for the lack of
snacks at bedtime.

108 There is a reference to a regular diet but no
indication of tube feeding. There is no reason given for
the lack of snacks at bedtime. P. Ex. 30 at 61.

108 There is an indication that this resident was
on a regular NAS diet for the entire month of December
1993. P. Ex. 30 at 64. Her flow sheets indicated "NA"
for the first half of the month and checks for the latter
half. Id. at 62-63. I cannot discern from these flow
sheets the reason for the change in snack service or why
no snack was provided in the first half of the month.

no Ms. Downing indicated that this marking means
no snack. Tr. 2049-2050.

m This resident has "NA", "N" and checks in the
various blocks for the month of December 1993. See P.
Ex. 30 at 11-12. Again, there is no indication of tube
feeding.

m2 There is no indication that this resident was
receiving tube feeding. P. Ex. 30 at 17.

3 There is no indication that this resident was
receiving tube feeding.

m4 There is no indication of tube feeding.
172

at 167, 5718); some have numerical markings (id. at

299, 35-36); some have a variety of notations on the
same page (id. at 7, 11, 16, 21, 23, 28-29, 36, 50, 53!”
59); and some have "gt"! (id. at 43-44, 51-54, 67-68).
Ms. Downing explained that a check mark or "y", which
means yes, indicates that snacks were offered to the
residents. Tr. 2047. She further testified that a dash
means that the snack was not accepted. But when I
inquired how she knows that the dash does not mean that
the snack wasn't offered, she said it would be documented
on back of the applicable flow sheet page. She admitted
that the backs of the flow sheets were not copied. Tr.
2052-2053.

My review of these flow sheets, particularly those with
dashes, "NA", "N", and "no", supports a finding that a
number of these residents were not offered bedtime snacks
and were not on special diets which would have precluded
such food. I do find Ms. Downing's explanation of the
meaning of a dash, and, arguably, similar meanings for
"N", and "no", to be lacking in credibility. Petitioner
assembled this exhibit and, if there was exculpatory
information on the back pages of the resident records, I

ms (...continued)

us This resident apparently was on NAS diet.
This diet is not explained in the record. I do note she
was an independent eater but had dietary restrictions.
There is no suggestion that a snack could not be provided
that was consistent with this resident's diet. P. Ex. 30
at 25-27.

6 Ms. Downing indicated that this marking means
no snack. Tr. 2049-2050.

n7 Again, there is no indication that this
resident is receiving tube feeding. P. Ex. 30 at 17.

ms This flow sheet also contains checks.

us This resident apparently was receiving a
supplementary nourishment. P. Ex. 30 at 31.

120 This resident apparently was receiving
gastric feeding.

11 Ms. Downing explained that there are three
types of tube feedings used at Petitioner. A "GT is for
gastrostomy tube. "JT" is for jejunostomy tube which is
inserted lower in the intestinal tract. "NT" is a
nasalgastric tube which goes through the nose to the
stomach of the resident. Tr. 2051-2052.
173

would expect such documents to be offered in evidence as
well. None were provided. The regulation requires the
provision of snacks at bedtime. If they were offered to
and rejected by the resident, it was incumbent on
Petitioner to document this occurrence. Absent records,
which are clearly the "best evidence" demonstrating such
rejection, I conclude that the bedtime snacks were
neither offered or provided.

Other records support that Petitioner did provide special
snacks to residents who requested something different
from the routine snacks. . Tr. 2039-2040; P. Ex. 30 at 73-
93. But I read 42 C.F.R. § 483.35(f)(3) to require the
facility to offer bedtime snacks to all residents unless
it is medically contraindicated. This Petitioner did not
do.

Petitioner introduced a document which it contends
reflects that it had a policy in place that "all
residents will be offered a bed time snack to the extent
medically possible." P. Ex. 30 at 94-95. Interestingly,
the document indicates that it was revised "12/93." Id.
at 94. Questioning Ms. Cox, Petitioner's counsel
suggested that the snack policy was revised prior to the
end of the survey. Tr. 1372. Ms. Cox responded that she
had no knowledge of such change in policy. Id. Ms. Cox
did testify that the supervisory or charge licensed nurse
who indicated that the policy was not to provide snacks
to residents unless mandated by their physicians or by a
specific resident's requests was responsible for an
entire nursing station servicing approximately 60
residents. Tr. 1381. She interpreted the statement of
the charge nurse concerning the availability of snacks as
representing the “routine of the facility." Tr. 1378.

Ms. Downing testified that the policy was revised in
December 1993, and while she had no knowledge of the
exact date of the change, she stated that she was advised
by the Director of Nursing at that time, Christina Tang,
that it occurred "before the survey." Tr. 2040-2041.

She testified further that she was not aware of any
policy that said that snacks would be offered only upon a
physician's order. Tr. 2041.

Petitioner presented no testimony from anyone on its
nursing staff who was present at the time of the survey
to contradict Ms. Cox's survey findings relating to this
deficiency. Contrary to Petitioner's assertion that a
revised policy existed at the time of the survey which
ensured that residents would be offered snacks at
bedtime, there is no explanation of the admission of its
charge nurse made during the survey which indicated a
174

bedtime snack policy different from the revised policy.
Moreover, I am dubious of the validity of the assertion
by Ms. Downing that the revision occurred before the
survey when the snack issue was raised at the time of the
survey”, The more likely scenario is that Petitioner
revised its policy based on the finding of the State
surveyor. There is no credible evidence that the policy
was revised before the survey was completed. Such a
change would have been noted by the State surveyor with
the possibility of no deficiency being found. This did
not occur. Accordingly, I cannot find that Petitioner
implemented the "Procedure for Bed Time (H.S.) Snack"
policy reflected in P. Ex. 30 at 94-95 until after the
survey was completed and the plan of correction was
submitted.

As a last argument, Petitioner asserts that the evidence
does not prove that the failure to provide snacks to
residents at bedtime represented a pattern at its
facility. P. Resp. Br. at 37-38. I reject this
argument. My review of P. Ex. 30 and the admission by
Petitioner's charge nurse amply demonstrate that a
pattern existed at Petitioner of violating the
regulation. Moreover, it follows that Petitioner's
failure to provide snacks as required by regulation would
likely result in a diminishment of the mental and
psychosocial well-being of its residents. Sucha
conclusion can be inferred from the statements of the
residents interviewed by Ms. Cox. Petitioner failed to
provide bedtime snacks daily to all of its residents, in
violation of 42 C.F.R. § 483.35(f) (3).

P. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 441
(HCFA Ex. 2 at 17-18):

42 C.F.R. 483.65(a)(1) (1) Investigates,
controls, and prevents infections in the
facility;

ReRKK

Based upon observation and medical record
review it was determined that staff failed to
provide care to prevent infections in the care
of residents.

2 The State surveyors indicated that before the
end of a survey they generally discuss the deficiencies
found with the staff of the facility being surveyed.
Here, the charge nurse was put on notice by Ms. Cox that
the snack policy was under review.
175
Findings include:

On 12/12/93 a licensed nurse was observed
taking a container of juice from the medication
cart into a resident's room and sitting it on
the resident's over-bed table. This resident
has a diagnosis of Methcillin [sic] resistant
staphylococcal infection and had a sign posted
above her bed that indicated that she was on
contact isolation. After the resident finished
taking her medications, the licensed nurse
returned the contained [sic] of juice to the
medication cart, increasing the risk of
spreading infection.

During observation of care of residents with
decubitus open areas it was noted that sterile
technique was not observed as per the facility
policy and procedure. A sterile tray used was
not kept sterile. Sterile gloves, dressings
and supplies used in the treatment were not
kept sterile to prevent infection in the open
wound.

Aseptic technique was not used in the care of
the wound.

With respect to the first part of the alleged deficiency,
concerning the medication nurse's handling of the juice
container, HCFA relies on the testimony of Ms. Cox and
Ms. Patience. Specifically, Ms. Cox stated at the
hearing that she observed a medication nurse taking a
juice container from the medication cart into the room of
a resident that had a documented infection and placing
the container on the resident's over-bed table. After
the nurse poured the juice into the resident's glass, the
nurse returned the contaminated juice container to the
top of the medication cart. Tr. 1105. Ms. Cox testified
that the nurse's action "({was} just not an acceptable
standard to follow to prevent infections." Id.; HCFA Br.
at 74. Ms. Cox testified further that "a common
container used for every patient" should never be taken
_into the room of a resident with an infection and
subsequently returned to a piece of equipment "used by
the general population." Tr. 1105-1106; HCFA Br. at 74-
75.

In addition, Ms. Patience testified:
If the resident is supposed to be kept on

contact isolation, that means that things are
not supposed to be leaving that room that have
176

come in contact with surfaces or the resident.
And, the fact that the juice container touched
the over-bed table and then was taken out,
broke that contact isolation.

Tr. 2626.

HCFA states that the resident's infection could have been
transmitted on the juice container. Finally, HCFA
asserts that, notwithstanding the particular nature of
the resident's infection, the action of the medication
nurse showed that appropriate precautions were not being
taken to prevent the spread of infection to other
residents. HCFA Br. at 75.

In response to the first part of the cited deficiency,
Petitioner states that HCFA's claim does not comport with
the facts. Specifically, Petitioner asserts that the
sole occasion where a nurse put a container of juice on
the over-bed table of a resident involved a resident who
was not isolated but was on "contact isolation." In
addition, the infection-spreading characteristics of
"non-colonized" residents with methicillin resistant
staphylococcal aureaus ("MRSA") differ from those of
"colonized" MRSA individuals, and the HCFA witnesses
lacked knowledge of the nature of the condition and were
unable to state whether the resident in question was
colonized. P. Br. at 139-144.

Petitioner further posits that the single act of placing
the container on the resident's over-bed table did not
risk spreading infection because the container was a
vector, and the resident's infection could not have been
transmitted by a vector. Rather, the infection could
have been carried only through contact with moist
secretions, of which there was no evidence. Finally,
Petitioner stated that if there was a deficiency, it was
corrected prior to the conclusion of the survey and
therefore should not have been in the HCFA 2567. P. Br.
at 140-141.

The essence of the first part of the alleged deficiency
is that the medication nurse's acts of placing a juice
container from the medication cart onto the over-bed
table of a resident on contact isolation with MRSA, and
then returning the container to the medication cart,
risked transmitting infection to other residents. Most
notably, I find the cornerstone of HCFA's proof, the
testimony of Ms. Cox concerning her observation of the
medication nurse's specific actions, both persuasive and
uncontradicted. Similarly, I note that Petitioner did
not specifically challenge the testimony of Ms. Cox that
177

the nurse's actions were inconsistent with standard
protocol. Rather, in response to the allegations in this
part of the deficiency, Petitioner submits that the facts
relating to the nature of the resident infection at issue
reveal that the infection could not have been transmitted
by the juice container alone. P. Br. at 140-141.

Notwithstanding its challenges, however, Petitioner
indicated that, whether or not the resident was
colonized, if any secretions had been transmitted to the
container when it was brought into the room and
subsequently returned to the medication cart, then the
transmission of infection could have occurred. P. Br. at
140. Petitioner nevertheless submits that the deficiency
lacks foundation because the HCFA witnesses were unable
to present any evidence that moist secretions were
present at the time of the observed actions. P. Resp.
Br. at 39.

I find this aspect of Petitioner's argument, however, to
be inapposite. That is, the issue at hand is not whether
moist secretions were actually present, or whether the
transmission of infection actually occurred. Rather, the
deficiency relates to whether the employee's actions
could have increased the risk of infection spreading
because the container could have come in contact with
moist secretions when it was brought into the room of a
resident on contact isolation, placed on that resident's
over-bed table and subsequently returned to the
medication cart.

Therefore, based on the testimony, strengthened by
Petitioner's acknowledgment that the infection of the
resident on contact isolation could have been transmitted
by contact with moist secretions, I conclude that the
record supports the existence of the cited deficiency.
Further, while the actions which were the subject of the
first part of the findings represent a single incident, I
find that the gravity of the breach in acceptable
protocol to be a substantial action supporting the
deficiency.’ Accordingly, because the observed actions

3 SOM 250 provides support for this conclusion.
A strong potential for harm can be a basis for
determining that a negative outcome results from a
deficient practice. An example is cited relating to the
potential for infection when “an observed facility
practice is so divergent from accepted principles of
practice that a future negative outcome or harm is
probable." HCFA Ex. 13 at P-30. These are precisely the
circumstances of the cited deficiency.
178

of the medication nurse could have increased the
possibility of transmission of infection, I find that the
first part of the cited deficiency represents a failure
by Petitioner to control and prevent infections as
required by 42 C.F.R. § 483.65(a) (1).

With respect to the second part of the alleged
deficiency, concerning whether sterile and/or aseptic
technique was used in the care of residents with
decubitus open areas, HCFA relies on the testimony of Ms.
Shekell:

in getting the materials necessary to dress
that open wound correctly good technique was
not used in cleansing and applying the dressing
as it should be. In other words, the -- staff
person, was a licensed person, contaminated the
area during the process of changing that
dressing.

Tr. 256.

HCFA relies also on the statement of Ms. Patience that
"neither sterile nor aseptic technique was used in caring
for [an] open wound. So that the resident was left open
to a greater risk of infection." Tr. 2627-2628, 2636;
HCFA Br. at 76-77.

In response to the second part of the alleged deficiency,
Petitioner avers that it was denied due process because
it was not afforded adequate notice of the identities of
all but one of the residents that were the subject of the
deficiency to confirm or deny the allegations and to
defend itself against them. Petitioner further asserts
that, while Ms. Shekell initially testified that the
deficiency related to resident 31, she later was
uncertain whether the alleged deficiency in fact related
to that resident. Petitioner stated also that there was
a failure of proof with respect to the deficiency as it
would relate to resident 31. Tr. 256, 756, 760-766; P.
Br. at 127-132.

In addition, Petitioner states that Ms. Shekell later
testified that a number of other residents were the
subject of the deficiency, but she could identify neither
the residents themselves, nor the staff who could provide
the names of the residents. Further, while Ms. Shekell
stated that the identities of the residents could be
ascertained from her notes, those notes had been
suppressed pursuant to my prior order. Petitioner argues
that HCFA's failure to identify the residents involved in
the deficiency not only denied Petitioner due process,
179

but also constitutes a complete failure of proof on the
issue. Finally, Petitioner contends that the deficiency
is defective because it is unclear whether HCFA's
allegations relate to non-sterile or non-aseptic
conditions. Tr. 616-618, 633; P. Br. at 133-138.

With regard to the second part of the alleged deficiency,
I find, as a preliminary matter, that the statement as
written in the HCFA 2567 is vague and confusing. That
is, while the first sentence in the statement speaks of
"residents" in the plural, and the failure to use
"sterile technique" as required by Petitioner's policy,
the last two sentences of the statement refer only to a
single "wound" and a failure to use "aseptic technique."
Thus, the document did not make clear whether this part
of the alleged deficiency related to the observation of
the treatment of one resident or more than one resident,
and whether the deficiency related to the failure to
follow sterile technique, aseptic technique, or both.

While HCFA was provided ample opportunity to submit
testimony and documentary evidence to clarify and support
this part of the alleged deficiency, it instead relied
predominantly on the testimony of Ms. Shekell at the
hearing. In her testimony, Ms. Shekell stated that
resident 31 was one of the subjects of the alleged
deficiency. Tr. 614-616, 751. Initially, Ms. Shekell
testified that this resident's wound was open, at risk of
infection, and was not dressed correctly. Tr. 256. On
cross-examination, however, Ms. Shekell was unable to
testify as to whether a sterile tray, sterile gloves, or
supplies were used with respect to the identified
resident, and she could not state the specific manner in
which the dressing used for the resident was not kept
sterile. Tr. 757-766. In addition, on cross-examination
it was revealed that the resident did not have an open
decubitus wound at the time of the survey. Tr. 772.

Further, while Ms. Shekell testified that other residents
were also the subject of the deficiency, she could
neither identify those residents nor identify the staff
nurse who accompanied her during the survey who would
know the identities of the residents. Tr. 614-616, 620,
632, 751-52. While Ms. Shekell indicated that her survey
notes reflected which residents were seen with respect to
the deficiency, those notes were not available because
they had been suppressed prior to the hearing. Tr. 639.

As I stated at the beginning of this decision, HCFA had
earlier moved to suppress the surveyors' notes in their
entirety on the basis of the deliberative process
privilege, and, in December 1994, I ruled in favor of
180

HCFA. It is important to note, however, that HCFA
instead could have moved to sanitize the surveyors' notes
by redacting information related to the deliberative
process privilege and preserving the factual information
contained in the notes for use in the proceedings. HCFA,
nevertheless, chose not to pursue this opportunity, and
it therefore could not use the factual elements of the
notes to support the witness' testimony concerning the
second part of the alleged deficiency.™

As an apparent consequence of the lack of documentation
available at the hearing, Ms. Shekell's testimony as a
whole emerged confused and contradictory. Further,
without her notes, the witness was unable to describe in
sufficient detail the facts underlying the stated
deficiency as they related to the residents who were

14 The somewhat confused state of the testimony
of the surveyor illustrates the risk inherent in HCFA's
strategy of relying on the privilege of deliberative
process and suppressing the surveyors' notes. Because
HCFA chose to rely solely on the testimony of the
surveyors in proving Petitioner's deficiencies,
the surveyors were forced to give testimony on specific
factual allegations without having their notes available
to assist them. Moreover, to the extent that the
surveyors relied on specific resident records when citing
Petitioner for a given deficiency during the survey,
these documents were withheld also as part of the
deliberative process privilege. Consequently, to prove
the existence of the cited deficiencies, HCFA was forced
to rely on a combination of 1) surveyors testifying
without their notes and 2) documents offered by
Petitioner. This led to confusing testimony because the
documents that would best refresh the surveyor's
recollection of the cited deficiency (the surveyors'
notes or copies of the specific documents they reviewed)
were not available to the surveyors during testimony. In
future cases, HCFA might be better served if its
surveyors created notes that were strictly factual in
nature and devoid of deliberative matters or other
information that, if revealed, might compromise HCFA's
survey process. This documentation could be used to
prove the existence of the cited deficiencies in a clear,
direct manner, and serve to refresh the recollection of
surveyors who are now forced to testify strictly from
memory. Had the surveyors' notes been available to be
used by the parties in this case, it may have reduced the
acrimony and lengthy argument which, in turn, led to the
voluminous hearing record.
181

observed, the particular nature of the wounds that were
treated, or the precise manner in which the residents'
wounds were treated. Moreover, HCFA failed to provide
any other testimony or documentation concerning the
residents and the staff actions observed in connection
with the second part of the deficiency. Absent this
necessary information, it is impossible to determine what
specific policies and procedures Petitioner was required
to follow, and did or did not follow, with respect to
sterile and/or aseptic treatment of resident wounds.

Accordingly, I conclude that HCFA failed to meet its
burden of proof with respect to the allegations contained
in the second part of the deficiency. Specifically, the
imprecise statement in the HCFA 2567, together with the
vague and at times inconsistent testimony presented,
failed to establish the existence of facts showing that
Petitioner failed to use sterile and/or aseptic technique
when required. Thus, with respect to the second part of
the alleged deficiency, HCFA did not meet its burden of
proving the elements which justify its determination that
sterile and/or aseptic technique was not followed when
required to control and prevent infection as required by
42 C.F.R. § 483.65(a) (1).

Q. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 443

HCFA Ex. 8):

42 C.F.R. 483.65(a)(3) (3) Maintains a record
of incidents and corrective actions related to

infections.
KEKE

On the HCFA 2567, no basis or findings were set forth for
this alleged deficiency. HCFA Ex. 2 at 18.

At the hearing, Ms. Shekell admitted that this citation
had been inadvertently keyed into the computer. Tr. 257.
Accordingly, because this alleged deficiency was cited in
error, I find that there is no deficiency here. F 443
has no bearing for purposes of this decision.
182

R. Set out below, in relevant part, is the statement _in

the HCFA 2567 concerning the alleged deficiency
identified as F 462 (HCFA Ex. 2 at 18-24) :'

42 C.F.R. 483.70(d)(1) (ii) Measure at least
80 square feet per resident in multiple
resident bedrooms, and at least 100 square feet
in single resident rooms;

RRKKK

Based on observation and record review the
facility failed to provide at least 80 square
feet per resident in 2/3 of the multiple
resident bedrooms.

RRKKK

Neither HCFA nor Petitioner offered any proof relating to
F 462 at the hearing or in their briefs. Accordingly, as
there is nothing in the record, I find that HCFA has
failed to prove the existence of this deficiency.

S. Set out below is the statement in the HCFA 2567
concerning the alleged deficiency identified as F 527
(HCFA Ex. 2 at 25):

42 C.F.R. 483.75(1)(1) (1) The facility must
maintain clinical records on each resident in
accordance with accepted professional standards
and practices that are -- (i) Complete; (ii)
Accurately documented; (iii) Readily
accessible; and (iv) Systematically organized.

RRKKK

Petitioner submitted P. Ex. 32 as being the relevant
resident record with respect to F 527. At the hearing,
however, HCFA did not present any testimony addressing
this alleged deficiency’, and Petitioner did not

present any testimony with respect to P. Ex. 32. Neither
HCFA nor Petitioner addressed F 527 in its briefs.

12s I do not restate the findings for F 462, which
are set forth at HCFA Ex. 2 at 19-24.

%6 I do not restate the remainder of the alleged
deficiency, which is set forth at HCFA Ex. 2 at 25.

127 HCFA's counsel stated that HCFA had not
presented any testimony on F 527. Tr. 2065.
183

Accordingly, I find that HCFA has failed to prove this
deficiency.

Conclusion

Petitioner takes issue with HCFA's determination that the
date of its certification as a Medicare provider of
skilled nursing services was effective on January 31,
1994. This date was based on Petitioner's submittal of
an acceptable Plan of Correction for deficiencies
contained in the HCFA 2567 which was prepared in
connection with an initial survey of Petitioner

during the period of December 14 - 23, 1993. Pursuant to
42 C.F.R. § 489.13, the effective date of Petitioner's
certification is the earliest date when there is
correction of the deficiencies found in the survey or
submission of an acceptable plan of correction. Under
this regulation, even one deficiency could be the basis
for a delay in the effective date of certification. The
record supports that deficiencies of 42 C.F.R. § 483 et.
seq. were present during the survey of Petitioner, were
not corrected at completion of the survey, and were the
subject of an acceptable plan of correction submitted on
January 31, 1994. Accordingly, I affirm HCFA's
determination that Petitioner's certification as a
Medicare provider was effective on January 31, 1994.

/s/

Edward D. Steinman
Administrative Law Judge