Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Freedom Allied Medical Supply Corp.
(Supplier No. 5768790001),

Petitioner
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-10-125
Decision No. CR2118

Date: April 23, 2010

DECISION

I grant summary judgment in favor of the Centers for Medicare and Medicaid Services
(CMS) and sustain CMS’s determination to revoke the Medicare supplier number of
Petitioner, Freedom Allied Medical Supply Corp. (Petitioner).

I. Background

Petitioner was enrolled in the Medicare program as a supplier of durable medical
equipment, prosthetics, orthotics, and supplies (DMEPOS). See 42 C.F.R. § 424.57. Ina
letter dated April 9, 2009, the Medicare contractor, Palmetto GBA National Supplier
Clearinghouse (contractor), notified Petitioner that its supplier number would be revoked
30 days from the postmark of the letter, pursuant to 42 C.F.R. §§ 405.874, 424.57(d), and
424.535(a)(5)(ii). CMS Ex. 3. The letter stated that a contractor representative (i.e., an
inspector) had attempted to conduct an inspection of Petitioner’s facility, but the facility
had been closed during the posted hours of operation on four separate occasions. In
response to the letter, Petitioner submitted a corrective action plan and sought
reconsideration. In a reconsideration decision, dated September 28, 2009, the Medicare
hearing officer found that Petitioner had failed to provide proof of liability insurance for
the period of July 20, 2008 through July 30, 2009, and affirmed the revocation of
Petitioner’s supplier number. CMS Ex. 12.

Petitioner requested a hearing before an administrative law judge (ALJ) by letter dated
November 9, 2009. I held a prehearing conference by telephone on December 14, 2009.
My December 23, 2009 Amended Order Following Prehearing Conference summarizes
the discussions held in the conference and contemplated that this case could be resolved
by summary disposition on the parties’ briefs and documentary exhibits.’

CMS filed a Motion for Summary Judgment and proffered twelve proposed exhibits,
CMS Exs. 1-12. Petitioner filed a response entitled “Motion for Judgment” (P.
Response), accompanied by the proffer of nine proposed exhibits that were marked as P.
Exs. 1-7, P. Ex. 7a, and P. Ex. 9. CMS filed a Reply Brief. In the absence of objection
rom either party, all proffered exhibits have been admitted to the record on which I
decide this case. My decision is based on the record before me, which includes the
documentary evidence admitted and the parties’ pleadings.

II. Controlling Statutes and Regulations

Section 1861(n) of the Social Security Act (Act) defines medical and other health
services that are eligible for Medicare reimbursement for DMEPOS suppliers. To receive
Medicare payments for items furnished to a Medicare-eligible beneficiary, a DMEPOS
supplier must have a supplier number issued by the Secretary of Health and Human
Services (Secretary). Act § 1834(j)(1)(A). A supplier may not obtain a supplier number
unless it meets the standards prescribed by the Secretary. Act § 1834(j)(1)(B). A
prospective DMEPOS supplier must meet all of the standards specified at 42 C.F.R.

§ 424.57(b) and (c) to be issued supplier billing privileges. Once billing privileges are
issued, CMS or the CMS contractor may revoke a supplier’s billing privileges for failure
to meet all of the standards specified. 42 C.F.R. §§ 424.57(c)(1), (d); 42 C.F.R.

§ 424.535(a)(1); 42 C.F.R. § 405.874.

Among other requirements, a supplier must permit CMS, or its agents, to conduct on-site
inspections to ascertain its compliance with governing regulations. Its location must be
accessible during reasonable business hours, and it must maintain a visible sign and post
its hours of operation. 42 C.F.R. § 424.57(c)(8).

' Following the prehearing conference, I issued an Order Following Prehearing
Conference, dated December 15, 2009. However, because the Order did not contain the
correct briefing deadlines, I issued an Amended Order Following Prehearing Conference
on December 23, 2009.
A supplier must also have a comprehensive liability insurance policy in place that covers
its place of business as well as all customers and employees. Specifically, the supplier
must have and maintain:

a comprehensive liability insurance policy in the amount of at least
$300,000 that covers both the supplier’s place of business and all customers
and employees of the supplier. In the case of a supplier that manufactures
its own items, this insurance must also cover product liability and
completed operations. Failure to maintain required insurance at all times
will result in revocation of the supplier’s billing privileges retroactive to the
date the insurance lapsed.

42 C.F.R. § 424.57(c)(10).
IIL. Issues, Findings of Fact, and Conclusions of Law
A. Issue

The issue before me in this case is whether Petitioner satisfied the requirements necessary
to participate in the Medicare program as a DMEPOS supplier. To do so, an entity or
individual must meet the standards set forth in 42 C.F.R. § 424.57(c)(10).

B. Findings of Fact and Conclusions of Law

CMS is entitled to summary judgment because the undisputed facts
establish that Petitioner did not satisfy the requirements necessary to
participate in the Medicare program as a supplier of services.”

In Senior Rehab. and Skilled Nursing Ctr., DAB No. 2300 (2010), the Departmental
Appeals Board (Board) stated the standards for summary judgment:

Summary judgment is appropriate when the record shows that there is no genuine
issue as to any material fact, and the moving party is entitled to judgment as a
matter of law. Kingsville Nursing and Rehabilitation Center, DAB No. 2234, at 3
(2009), citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986). While the
Federal Rules of Civil Procedure (FRCP) are not binding in this administrative
appeal, we are guided by those rules and by judicial decisions on summary
judgment in determining whether the ALJ properly granted summary judgment.
See Thelma Walley, DAB No. 1367 (1992)... . The party moving for summary
judgment bears the initial burden of showing that there are no genuine issues of
material fact for trial and that it is entitled to judgment as a matter of law.
Kingsville at 3, citing Celotex, 477 U.S. at 323. If the moving party carries its

> I make this one finding of fact/conclusion of law.
initial burden, the non-moving party must “come forward with ‘specific facts
showing that there is a genuine issue for trial.” Matsushita Elec. Industrial Co. v.
Zenith Radio, 475 U.S. 574, 587 (1986) (quoting FRCP 56(e)). To defeat an
adequately supported summary judgment motion, the non-moving party may not
rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute
concerning a material fact - - a fact that, if proven, would affect the outcome of the
case under governing law. Jd. at 586, n.11; Celotex, 477 U.S. at 322. In
determining whether there are genuine issues of material fact for trial, the reviewer
must view the evidence in the light most favorable to the non-moving party,
drawing all reasonable inferences in that party’s favor. U.S. v. Diebold, Inc., 369
USS. 654, 655 (1962). ... Whether summary judgment is appropriate is a legal
issue that we address de novo. Lebanon Nursing and Rehabilitation Center, DAB
No. 1918 (2004). In reviewing whether there is a genuine dispute of material fact,
we view the proferred evidence in the light most favorable to the non-moving
party. Kingsville at 4, and cases cited therein.

Senior Rehab., DAB No. 2300 at 3. The Board has also noted that the role of an ALJ in
deciding a summary judgment motion differs from the ALJ’s role in resolving a case after
a hearing. The ALJ should not engage in assessing credibility or evaluating the weight of
conflicting evidence. Holy Cross Vill. at Notre Dame, DAB No. 2291 at 4-5 (2009).

I find that summary judgment is appropriate because there are no material facts in
dispute, and because this case turns entirely on questions of law. I conclude that CMS’s
position is correct as a matter of law.

Here, the basic and dispositive facts are not in dispute. Petitioner was a DMEPOS
supplier that participated in the Medicare program. Its posted hours of operation were
9:00 a.m. to 5:00 p.m. Monday through Friday, and 10:00 a.m. to 2:00 p.m. on Saturday.
CMS Ex. 1 at 3. On October 22, 2008, a site inspector from the contractor’s Supplier
Audit and Compliance Unit attempted to inspect Petitioner’s facility but found the facility
closed during posted hours of operation, with the shutters up and the door locked. There
was no answer when the inspector rang the doorbell and knocked repeatedly. Id. at 1-2.
On October 27, 2008, the inspector made a second attempt to inspect Petitioner’s facility.
Again, the facility was closed. Jd. The inspector returned to the facility two more times
during posted hours of operation on December 30, 2008, and January 5, 2009. CMS Ex.
2 at 1-2. On both these succeeding occasions, the facility was closed, and no one
responded to his knocks. Id.

Ina letter dated April 9, 2009, the contractor notified Petitioner that because an
inspection of its facility could not be completed, it concluded that Petitioner was not
operational. Therefore, the contractor revoked Petitioner’s supplier number, effective 30
days from the postmark of the letter. CMS Ex. 3. The letter advised Petitioner that it had
the right to appeal the revocation decision within 60 days of the letter’s postmark and/or
submit a corrective action plan within 30 days of the letter’s postmark. Jd. On May 28,
2009, Petitioner sent a letter to the contractor “requesting for [sic] a corrective action plan
or hearing,” accompanied by copies of letters showing that one employee had been
terminated, and another employee had been hired. CMS Ex. 4.

On June 15, 2009, the inspector made a fifth attempt to inspect Petitioner’s facility.
However, again, the door was locked, and no one answered the doorbell. CMS Ex. 5 at
1-2. The inspector returned to the premises the next day, June 16, 2009, and Petitioner’s
representative, Ambrose Ezemma, answered the doorbell after about ten minutes. CMS
Ex. 5 at 2. The inspector was able to conduct an on-site inspection, during which he
asked Mr. Ezemma for proof of insurance coverage. Mr. Ezemma provided the inspector
with a copy of Petitioner’s certificate of liability insurance from Nationwide Mutual
Insurance Company. The certificate listed the policy effective date as July 20, 2006, and
the policy expiration date as July 20, 2007. CMS Ex. 5 at 8. Mr. Ezemma agreed to
provide the contractor with additional documentation within two business days, including
proof of a comprehensive liability insurance policy and/or “the Certificate of Insurance
showing [the contractor] as the certificate holder.” CMS Ex. 5 at 10.

By facsimile, dated June 30, 2009, the contractor informed Mr. Ezemma that Petitioner’s
corrective action plan was being processed and advised Mr. Ezemma that he still needed
to submit a certificate of insurance that listed the contractor as a certificate holder. The
facsimile stated — as I have noted above — that the insurance certificate on file with the
contractor had expired on July 20, 2007. CMS Ex. 6 at 1.

On June 26, 2009, Mr. Ezemma submitted a completed Medicare Enrollment Application
(form CMS-855S), which the contractor received on July 10, 2009, in which Mr.
Ezemma requested a voluntary termination of Petitioner’s enrollment in the Medicare
program effective August 15, 2009. CMS Ex. 7 at 4, 15, 32.

By letter, dated July 30, 2009, the contractor informed Petitioner that it had received its
request for a corrective action plan and reconsideration. CMS Ex. 8. The letter advised
Petitioner further that it was “unable to reinstate/issue [its] DMEPOS billing number,”
because the information submitted did not establish that Petitioner was in compliance
with all failed standards. The letter stated that Petitioner’s reconsideration request had
been forwarded to a Medicare hearing officer for review. Id.

On July 31, 2009, Mr. Ezemma faxed to the contractor a copy of a certificate of insurance
rom Nationwide Mutual Fire Insurance Co. that listed the policy’s effective date as July
31, 2009 and the policy’s expiration date as July 31, 2010. CMS Ex. 9.

The contractor notified Mr. Ezemma on August 10, 2009, via facsimile, that Petitioner’s
corrective action plan and reconsideration request were being processed and that
Petitioner still needed to provide a “Certificate of Insurance with [the contractor] (and

address) listed as a certificate holder for the periods of July 21, 2007- July 21, 2008 and
July 22, 2008 — July 30, 2009.” CMS Ex. 10.

On August 11, 2009, Mr. Ezemma faxed to the contractor two certificates of insurance
from Nationwide Mutual Insurance Company. One certificate that covered the period
July 20, 2006 through July 20, 2007, and another certificate covered the period July 31,
2009 through July 31, 2010 (he had previously provided this latter certificate to the
contractor). Mr. Ezemma also faxed a policy declaration from the insurance company
indicating coverage for the period July 20, 2007 to July 20, 2008. CMS Ex. 11.

A Medicare hearing officer issued a reconsideration decision, dated September 28, 2009.
CMS Ex. 12. The Medicare hearing officer recited the inspector’s five unsuccessful
attempts to inspect Petitioner’s facility, stated that the contractor had revoked Petitioner’s
supplier number on May 9, 2009, for noncompliance with Medicare Supplier Standards,
and noted that, on July 30, 2009, the contractor upheld the revocation of Petitioner’s
supplier number for noncompliance with Medicare Supplier Standard #10 (42 C.F.R.

§ 424.57(c)(10)), which requires a supplier to have a comprehensive liability insurance
policy in place that covers its place of business as well as all customers and employees.
In explaining the rationale for the decision, the Medicare hearing officer described the
contractor’s requests in June and August 2009 for proof of up-to-date insurance from
Petitioner and noted what documents Petitioner had furnished in response. The Medicare
earing officer found that Petitioner had failed to provide any documentation “to verify
that insurance was up-to-date and in place for the July 20, 2008 — July 30, 2009 time
rame.” CMS Ex. 12 at 2.

Petitioner asserts that it maintained a comprehensive liability insurance policy of at least
$300,000 but acknowledges that a “lag” occurred in its insurance coverage because of
“communications issues” with its insurance company, Nationwide Mutual Insurance. P.
Response at 2. Petitioner claims that because of a change of its insurance agent, the
premiums it paid for its business liability policy were incorrectly applied to its auto
insurance policy. Petitioner admits that it was unaware that its liability insurance policy
was “ineffective” until the on-site inspection occurred. Jd. Petitioner asserts that it
renewed its policy immediately.

Petitioner notes further that, because of the “bad economy,” it submitted an application to
voluntarily terminate its enrollment in the Medicare program, effective August 15, 2009.
However, the application was returned, and it was “directed to do a [corrective action
plan].” P. Response at 1. Petitioner states that it operated the business from July 2006
through August 2009, when “the business was shut down.” Jd. at 2. In this context of
summary judgment analysis, I accept as true Petitioner’s assertions that it did have a
liability insurance policy in place and that the lapse in insurance coverage was due to
premiums being credited to the wrong account. | also accept that Petitioner’s business
closed in August 2009.

Although Petitioner’s request for hearing stated that the facts set forth in the September
28, 2009 reconsideration decision are “not accurate,” Petitioner has not disputed any of
the facts set forth in CMS’s briefs. The record shows that, at the time of the June 16,
2009 on-site inspection, Petitioner produced an expired certificate of insurance and failed
to provide proof of current comprehensive liability insurance coverage for its business,
customers, and employees. Following the inspection, in response to the contractor’s
specific requests for proof of insurance coverage, Petitioner was only able to provide
certificates of insurance and/or a policy declaration covering the following periods: July
20, 2006 to July 20, 2007; July 20, 2007 to July 20, 2008; and July 31, 2009 to July 31,
2010. The contractor specifically requested that Petitioner provide a certificate of
insurance with the contractor listed as a certificate holder for the time period “July 22,
2008 — July 30, 2009.” CMS Ex. 10. However, Petitioner failed to provide any proof
that it had an active comprehensive liability insurance policy for the period July 20, 2008
to July 30, 2009.

By its own admission, Petitioner did not have a valid comprehensive liability insurance
policy in effect at the time of the June 16, 2009 on-site inspection. Petitioner
acknowledges that it was unaware of any lapse in its insurance coverage, until the
inspector inquired about its insurance policy, but then took immediate steps to renew its
policy. Petitioner has made no attempt to show that it had a valid insurance policy in
effect at the time of the June 16, 2009 on-site inspection.

Petitioner’s claim that its failure to maintain an active liability insurance policy was due
to a miscommunication with its insurance company is irrelevant. To the extent that
Petitioner may be seeking relief on equitable grounds, it is beyond my authority to
consider or grant such relief. See Oklahoma Heart Hosp., DAB No. 2183 (2008);
Community Hosp. of Long Beach, DAB No. 1938 (2004). Further, the fact that Petitioner
submitted an application requesting voluntary termination of its enrollment in the
Medicare program, effective August 15, 2009, has no bearing on my analysis. On the
date its facility was inspected, June 16, 2009, Petitioner was enrolled in the Medicare
program as a DMEPOS supplier, and, as such, was required to be in compliance with all
of the standards set forth in 42 C.F.R. § 424.57(c).

Based on these facts, I find that Petitioner failed to maintain a comprehensive liability
insurance policy of at least $300,000 covering its place of business, as well as all
customers and employees, at all times, and was therefore out of compliance with the
standard set forth in 42 C.F.R. § 424.57(c)(10). CMS therefore properly revoked its
billing privileges. 42 C.F.R. § 424.57(d).
IV. Conclusion

Because the undisputed facts establish that Petitioner violated 42 C.F.R. § 424.57(c)(10),
I grant CMS’s motion for summary judgment and sustain the revocation of Petitioner’s
supplier number.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Sunset Estates
(CCN: 37-5446),

Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-10-387
Decision No. CR2117

Date: April 19, 2010

DECISION

This matter is before me on the Parties’ Joint Response to Request for Position
Statements, dated March 26, 2010. Petitioner’s Request for Hearing, dated January 26,
2010, was received and docketed by the Civil Remedies Division on February 4, 2010.
My Acknowledgement and Initial Docketing Order gave the parties 30 days to file
Reports of Readiness. The parties submitted a timely Joint Report of Readiness
accompanied by a March 3, 2010 letter from the Centers for Medicare and Medicaid
Services (CMS) rescinding all remedies. In a letter, dated March 16, 2010, I noted that if
all remedies have been rescinded, well-settled Departmental Appeals Board precedent
would suggest that there was no remaining right to a hearing for Petitioner. I directed the
parties to respond with their position on this issue by March 26, 2010.

1. Background

Sunset Estates, Petitioner, received a notice from the Oklahoma State Department of
Health (OSDH) stating that as a result of an October 15, 2009 Life Safety Code survey
and an October 19, 2009 Health Safety Code survey, Petitioner was determined to be out
of substantial compliance with Medicare and Medicaid requirements. By notice, dated
November 30, 2009, CMS informed Petitioner that it would terminate the facility’s
provider agreement, effective April 19, 2010, if substantial compliance was not achieved
by that date. Additionally, the November 30, 2009 CMS notice letter stated that CMS
would impose a denial of payment for all new Medicare and/or Medicaid admissions
(DPNA), effective December 15, 2009, and would impose a civil money penalty (CMP)
in the amount of $5,800 per day for October 16 and 17, 2009, and then a CMP in the
amount of $1,250 per day beginning October 18, 2009. Subsequently, by notice letter
dated February 4, 2010, CMS informed Petitioner that it had added another per-day CMP
of $50 starting January 5, 2010 and that the CMP of $1,250 per day would be in effect for
the period beginning October 18, 2009 through January 4, 2010.

Petitioner achieved substantial compliance in a follow-up survey. OSDH determined the
date of substantial compliance to be January 7, 2010.

On March 3, 2010, CMS informed Petitioner that the termination was rescinded and that
all the CMPs were also rescinded. Further, the March 3, 2010 letter from CMS informed
Petitioner that the DPNA effective date beginning December 15, 2009 was revised to an
effective date of January 19, 2010. The March 3, 2010 letter stated that since Petitioner
had achieved substantial compliance as of January 8, 2010, which is prior to the date the
DPNA was to take effect, the DPNA would not take effect and that the DPNA remedy
was also rescinded.

CMS asserts that it has rescinded all the enforcement remedies it sought to impose
against Petitioner. Petitioner does not contest this assertion. Thus, the issue before me is
whether a long-term care facility has a right to a hearing when CMS withdraws the
enforcement remedies provided for in 42 C.F.R. § 488.406. This issue is hardly novel.
All of the Administrative Law Judges (ALJs) of the Civil Remedies Division, including
myself, have addressed it many times, and have without exception come to the same
resolution of that issue I announce here. I find and conclude that Sunset Estates is not
entitled to a hearing, and, on the basis of 42 C.F.R. § 498.70(b), I dismiss Petitioner’s
hearing request.

42 C.F.R. Part 498 set forth the hearing rights of a long-term care facility. A provider
dissatisfied with CMS’s initial determination is entitled to further review, but
administrative actions that do not constitute initial determinations are not subject to
appeal. 42 C.F.R. § 498.3(d). The regulations specify which actions are “initial
determinations” and set forth examples of actions that are not. A finding of
noncompliance that results in the imposition of a remedy specified in 42 C.F.R. §
488.406 is an initial determination for which a facility may request a hearing. 42 C.F.R.
§ 498.3(b)(13). Unless the finding of noncompliance results in the actual imposition of a
specified remedy, however, the finding is not an initial determination. 42 C.F.R.

§ 498.3(d)(10)(ii). Where, as here, CMS does not impose a remedy, or rescinds all
proposed remedies, a facility has no hearing right because no determination properly
subject to a hearing exists. It is the final imposition of an enforcement remedy or
sanction and not the citation of a deficiency that triggers a facility’s right to a hearing
pursuant to 42 C.F.R. Part 498. Fountain Lake Health & Rehab., Inc., DAB No. 1985
(2005); Lakewood Plaza Nursing Ctr., DAB No. 1767 (2001); Lutheran Home-
Caledonia, DAB No. 1753 (2000); Schowalter Villa, DAB No. 1688 (1999); Arcadia
Acres, Inc., DAB No. 1607 (1997).

In the Parties’ March 26, 2010 Joint Response to Request for Position Statements, the
parties conceded that my jurisdiction over this matter has “ended with the rescission of
CMS’s proposed remedies in CMS’s letter issued March 3, 2010.” March 26, 2010
Response at 4. However, Petitioner did not follow up by withdrawing its hearing request
or by asking that this case be dismissed. I am authorized to dismiss a hearing request
when a petitioner does not have a right to a hearing pursuant to 42 C.F.R. § 498.70(b)
and, for that reason, I do so now in this matter. Petitioner’s January 26, 2010 Request for
Hearing must be, and it is, DISMISSED. The parties may request that an order
dismissing a case be vacated pursuant to 42 C.F.R. § 498.72.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Life Care Center of Jefferson City
(CCN: 44-5275),

Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-08-345
Decision No. CR2115

Date: April 20, 2010

DECISION

Petitioner, Life Care Center of Jefferson City, challenges the decision of the Centers for
Medicare and Medicaid Services (CMS) that it was not in substantial compliance with
program participation requirements and CMS’s imposition of remedies, including: a civil
money penalty (CMP) totaling $1,410,000; a denial of payment for new admissions
(DPNA) from January 30, 2008 through February 3, 2008, and loss of Petitioner’s ability
to operate a nurse aide training and competency evaluation program (NATCEP) for two
years. For the reasons discussed below, I find that Petitioner was not out of substantial
compliance with participation requirements during the relevant period and, thus, the
record does not support CMS’s determination to impose the stated remedies.

I. Background

On January 22, 2008, the Tennessee State Survey Agency (state agency) completed a
complaint investigation at Petitioner’s Jefferson City, Tennessee facility, which resulted
in CMS notifying Petitioner by letter, dated January 28, 2008, that it had been found out
of substantial compliance with participation requirements. As a result, CMS imposed
remedies, including: a CMP of $10,000 per day effective September 17, 2007, which
was to continue until immediate jeopardy was removed or Petitioner was terminated; a
DPNA effective when notice requirements could be met; loss of NATCEP; and
discretionary termination on February 14, 2008, if the immediate jeopardy was not
removed by that date. CMS Exhibit (CMS Ex.) 15; Petitioner Exhibit (P. Ex.) 2. On
February 8, 2008, CMS notified Petitioner that it was back in substantial compliance with
participation requirements as of February 4, 2008 and noted that the DPNA was in effect
from January 30, 2008 through February 3, 2008. CMS Ex. 11; P. Ex. 3. It is
uncontested that the amount of the CMP, as of that date, amounted to $1,410,000. P. Br.
at 1, 45; CMS Br. at 4.

Petitioner requested a hearing by letter, dated March 11, 2008. The case was assigned to
me for hearing and decision on March 20, 2008. I initially scheduled a hearing to
commence December 9, 2008. I agreed to postpone that hearing pending a state
administrative law judge (ALJ) decision in a parallel state proceeding, as the parties
indicated a possibility existed that the case would settle following issuance of that
decision.! On January 7, 2009, in the absence of settlement, I rescheduled the hearing. I
held the hearing in Knoxville, Tennessee from June 16-18, 2009. A 409-page transcript
of the hearing (Tr.) was prepared. Testifying for CMS was Beverly Cox, Registered
Nurse (R.N.) (Surveyor Cox), a surveyor for the state agency. Testifying for Petitioner
were: Karen Moceri, R.N., Petitioner’s Assistant Director of Nursing (ADON Moceri);
Brandy Klein, Licensed Practical Nurse (L.P.N.) (LPN Klein); Teresa Williams, R.N.,
Petitioner’s Director of Nursing (DON Williams); Shirley Miller, L.P.N. (LPN Miller);
Annette O’Brien, R.N., an expert witness in matters involving long term care nursing
(Ms. O’Brien); and Warren Stinson, D.D.S. (Dr. Stinson). I admitted CMS Exs. 1-39 and
P. Exs. 1-43. CMS submitted a post-hearing brief (CMS Br.), and Petitioner submitted a
post-hearing brief (P. Br.) and a post-hearing reply brief (P. Reply).

IL. Issues

1. Whether Petitioner was out of substantial compliance with participation
requirements.

2. If Petitioner was out of substantial compliance with participation
requirements, whether the remedies imposed are reasonable.

Ill. Applicable Law
The statutory and regulatory requirements for Medicare participation by a long-term care

facility are found at sections 1819 (skilled nursing facility or SNF) and 1919 (nursing
facility or NF) of the Social Security Act (Act), and at 42 C.F.R. Part 483. Section

' [have not been provided with a copy of a decision from that proceeding.

> CMS did not object to the designation of Ms. O’Brien as an expert witness in long term
care nursing. Tr. 337.
1819(h)(2) of the Act vests the Secretary of the Department of Health and Human
Services (Secretary) with authority to impose enforcement remedies against a SNF for
failure to comply substantially with federal participation requirements established by
sections 1819(b), (c), and (d) of the Act (section 1919(h)(2) of the Act gives similar
enforcement authority to the states). Included among these remedies are: termination of
a noncompliant facility’s participation in Medicare; imposition of a DPNA; CMPs; and
appointment of temporary management. Act § 1819(h)(2)(B). The Secretary has
delegated authority to CMS and the states to impose remedies against a long-term care
facility that is not complying substantially with federal participation requirements.
“Substantial compliance means a level of compliance with the requirements o
participation such that any identified deficiencies pose no greater risk to resident health
or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301 (emphasis in
original). A deficiency is a violation of a participation requirement established by
sections 1819(b), (c), and (d) of the Act, or the Secretary’s regulations at 42 C.F.R. Part
483, Subpart B. Facilities that participate in Medicare may be surveyed on behalf of
CMS by state survey agencies to determine whether the facilities are complying with
ederal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-335.

The regulations specify the enforcement remedies that CMS may impose if a facility is
not in substantial compliance with Medicare requirements, including imposition of
CMPs. 42 C.F.R. § 488.406. CMS may impose a CMP for each day a facility is not in
substantial compliance, or for each instance of noncompliance. The regulation provides
that a CMP that is imposed against a facility on a per day basis will fall into one of two
ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, from
$3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate
jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.
42 C.F.R. §§ 488.438(a)(1)(i), (d)(2). “Zmmediate jeopardy means a situation in which
the provider’s noncompliance with one or more requirements of participation has caused,
or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R.
§ 488.301 (emphasis in original). The lower range of a CMP, from $50 per day to $3,000
per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either
cause actual harm to residents or cause no actual harm but have the potential for causing
more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). CMS is authorized to impose a
per instance CMP (PICMP) from $1,000 to $10,000, whether or not immediate jeopardy
is identified. 42 C.F.R. § 488.438(a)(2).

The Act and regulations make a hearing before an ALJ available to a long-term care
acility against which CMS has determined to impose an enforcement remedy. Act

§ 1128(A)(c)(2); Act § 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). The hearing
before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, DAB CR65 (1990),
aff'd, 941 F.2d 678 (8th Cir. 1991); Emerald Oaks, DAB No. 1800 at 11 (2001);
Beechwood Sanitarium, DAB No. 1906 (2004); Cal Turner Extended Care Pavilion,
DAB No. 2030 (2006); Residence at Salem Woods, DAB No. 2052 (2006). A facility has
a right to appeal a “certification of noncompliance leading to an enforcement remedy.”

See 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3. However,
CMS's choice of remedies, or the factors CMS considered when choosing remedies, are
not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the
scope and severity level of noncompliance that CMS finds, if a successful challenge
would affect the range of the CMP that CMS could impose or impact the facility’s
authority to conduct a NATCEP. 42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10)(i).. The CMS
determination as to the level of noncompliance “must be upheld unless it is clearly
erroneous” (42 C.F.R. § 498.60(c)(2)), including the finding of immediate jeopardy.
Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Departmental
Appeals Board (Board) has long held that the net effect of the regulations is that a
provider has no right to challenge the scope and severity level assigned to a
noncompliance finding, except in the situation where that finding was the basis for an
immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1750 (2000).
ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The standard of proof or quantum of evidence required is a preponderance of the
evidence. CMS has the burden of coming forward with evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense. See
Hillman Rehab. Ctr., DAB No. 1611 (1997), aff'd, No. 98-3789, 1999 WL 34813783
(D.N.J. May 13, 1999); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Emerald
Oaks, DAB No. 1800; Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004),
aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. Appendix 181 (6th Cir.
2005); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004).

IV. Discussion

My conclusions of law are set forth in bold, followed by a statement of facts and my
analysis.

1. Petitioner was in substantial compliance with participation requirements.

This case involves the care that Petitioner provided to a gravely ill resident, Resident 1,
who died at Petitioner’s facility on September 17, 2007. The state agency completed a
complaint survey, along with Petitioner’s annual survey, in October 2007, shortly after
Resident 1’s death. The state agency reviewed Resident 1’s chart and a surveyor, or
surveyors, talked to employees, after which it was determined that the complaint was
unsubstantiated, and no deficiencies concerning Resident 1’s care were cited. Tr. 239,
243. The state agency returned on January 22, 2008 to reexamine the case, after Resident
1’s daughter lodged a complaint. Tr. 95-96. Following that second complaint survey,
which Surveyor Cox conducted,’ Petitioner was found out of compliance with
participation requirements, and the above-noted remedies were imposed.

The January 22, 2008 statement of deficiencies recites that Petitioner,

[F]ailed to document and medicate for pain, assess the resident’s vital signs, notify
the physician of the resident’s complaints of pain, and the resident’s request for a
transfer to the hospital, prevent neglect, and failed to thoroughly investigate an
allegation of neglect placing resident (#1) in Immediate Jeopardy.

P. Ex. 1 at 1. The statement of deficiencies asserts that due to Petitioner’s deficiencies,
Petitioner was out of compliance with the following participation requirements at the
level of immediate jeopardy*: 42 C.F.R. § 483.10(b)(11) (F Tag 157, SS-J); 42 C.F.R.

§ 483.13(c) (F Tag 224, SS-J); 42 C.F.R. § 483.13(c) (F Tag 226, SS-J); 42 C.F.R.

§ 483.20(k)(3)(i) (F Tag 281, SS-J); 42 C.F.R. § 483.25 (F Tag 309, SS-J); and 42 C.F.R.
§ 483.75 (F Tag 490, SS-J). In addition, the statement of deficiencies asserts that
Petitioner was out of compliance with other requirements at a non-immediate jeopardy
level: 42 C.F.R. § 483.10(b)(4) (F Tag 155, SS-D);° 42 C.F.R. §§ 483.20, 483.20(b) (F
Tag 272, SS-D); 42 C.F.R. § 483.75(1)(1) (F Tag 514, SS-D). Below, I do not discuss the

* Tt is unclear whether other surveyors participated in this survey. The only surveyor to
testify and that CMS refers to, however, is Surveyor Cox.

+ Scope and severity levels are used by CMS and a state when selecting remedies. The
scope and severity level is designated by an alpha character, A through L, selected by
CMS or the state agency from the scope and severity matrix published in section 7400E
of the State Operations Manual (SOM). See 42 C.F.R. § 488.408. A scope and severity
level of A, B, or C indicates a deficiency that presents no actual harm but has the
potential for minimal harm. Facilities with deficiencies of a level no greater than C
remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D,
E, or F indicates a deficiency that presents no actual harm but has the potential for more
than minimal harm that does not amount to immediate jeopardy. A scope and severity
level of G, H, or I indicates a deficiency that involves actual harm that does not amount
to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that
constitute immediate jeopardy to resident health or safety. The matrix, which is based on
42 C.F.R. § 488.408, specifies which remedies are required and optional at each level
based upon the frequency of the deficiency, i.e., whether a deficiency is isolated, part of a
pattern, or widespread. Jd. The immediate jeopardy level deficiencies under review here
were found to be at a level J, which indicates that they are isolated.

* This Tag includes a reference both to Resident 1 and to another resident, Resident 10.
CMS presented no argument or evidence with regard to Resident 10, and I do not address
Resident 10 in this decision. The Tag involves the “advance directives” citation under
(continued...)

lower level deficiencies (other than 42 C.F.R. §§ 483.20, 20(b) (F Tag 272), which CMS
discusses with 42 C.F.R. § 483.20(k)(3)(i) (F Tag 281)). CMS did not submit any
argument, or evidence, specifically regarding them and, other than the example of
Resident 10 (see n.5), they relate solely to Petitioner’s care of Resident 1. Instead, I
discuss Resident 1’s baseline condition, the events of the night in question upon which
the deficiencies were based, and then specifically reference each of the regulatory
citations cited as immediate jeopardy above, in finding that Petitioner was in compliance
with participation requirements.

a. Resident 1’s complicated medical history and its impact on her
baseline condition during her stay at Petitioner’s facility.

Resident 1’s medical history included diverticular disease, atrial fibrillation,
hypertension, reflux disease, anxiety, osteoarthritis, hyperlipidemia, chronic back pain,
multiple knee surgeries, open cholecystectomy, and hysterectomy. P. Ex. 7 at 2.
Resident | suffered a perforated duodenal ulcer in May 2007. P. Ex. 6, P. Ex. 7. A
perforated ulcer is a life-threatening condition, and there is a high mortality rate
associated with it. Tr. 348. Resident 1 had surgery in an attempt to repair the
perforation, but the surgery was unsuccessful and complications developed. Tr. 109,
353-54; P. Ex. 6, P. Ex. 7; CMS Ex. 23 at 11. Over the course of the next few months,
Resident 1 was transferred between two hospitals, St. Mary’s Hospital and Select
Specialty Hospital (a long term acute care hospital). P. Ex. 6, P. Ex. 7; Tr. 102. An
August 2, 2007 entry from Resident 1’s physical examination notes, compiled at Select
Specialty Hospital, recites that “[t]he patient is reasonably stable, but she is very
fatalistic, obviously quite depressed and may have a mixture of dementia and so-called
hospital psychosis as well given the fact that she has been here for months now.” CMS
Ex. 23 at 13.

*(...continued)

the regulation. CMS asserts that Resident 1’s husband, not the resident herself, signed a
Tennessee advance directive document known as a “Physician Orders for Scope of
Treatment (POST)” that included a do not resuscitate provision. With regard to Resident
1, Surveyor Cox asserted that she cited a deficiency, because it made the person doing
Resident 1’s admission paperwork uncomfortable discussing advance directives with
residents upon admission. In addition, she determined that Resident 1 was competent to
sign the form for herself. Tr. 85; P. Ex. 5. But, the family and resident questionnaire
completed upon Resident 1’s admission notes that the resident was not physically able to
complete the questionnaire, which included a question referencing whether the advanced
directive had been signed. P. Ex. 4 at 1-2. And, the POST form itself provides that a
surrogate may sign if the surrogate is aware of the patient’s wishes. P. Ex. 5. I do not
find this citation to constitute a deficiency.
Resident 1 was admitted to Petitioner’s facility on August 31, 2007, with drains for waste
removal and acid drainage, a gastric tube in her stomach that could be unclamped when
necessary to relieve discomfort, and a jejunostomy tube to permit tube feeding. Tr. 103,
107-08, 110, 354; CMS Ex. 23 at 56. Her admission documentation noted that she was
not physically able to complete the family and resident questionnaire and that the
responsible party filling it out was her husband. It also noted that she had acute stomach
pain that resolved with medication. P. Ex. 4 at 1-2.

Petitioner’s staff assessed Resident | upon admission and during her residence at the
facility. P. Exs. 8-15. The assessments note her history of unsuccessful surgeries and
reflect that she was on a feeding tube. The minimum data set (MDS), which is a

comprehensive assessment done upon admission and periodically throughout a resident’s

stay in a facility, notes that the resident had persistent anger, a sad, pained, worried facial
expression, and had periods of crying and tearfulness, and had repetitive health
complaints. Her mood was documented as not being easily altered. P. Ex. 8 at 5. A

September 4, 2007 Resident Assessment Protocol (RAP) worksheet for behaviors notes
that “[t]he resident was recently admitted to the facility. Since admission she has been
easily upset/irritated, experiences anxious health concerns, insomnia, exhibits sad/pained
affect at times, tearful episodes and resistant to care.” P. Ex. 8 at 22. A September 4,
2007 RAP worksheet for cognitive loss and dementia notes that she is “alert/oriented, but
has impaired short term memory.” P. Ex. 8 at 19. A September 4, 2007 Mood State RAP
notes “[s]ince admission she has been easily upset/irritated, experiences anxious health
concerns, insomnia, exhibits sad/pained affect at times, tearful episodes and resistant to
care.” P. Ex. 8 at 30; Tr. 246-55.

The resident’s history of persistent pain, nausea, and vomiting was addressed. Her MDS
noted moderate pain. P. Ex. 8 at 7, 14. A pain assessment noted “internal stomach pain
related to perforated ulcer” for which Lortab and Darvocet were prescribed. P. Ex. 10.

An activities assessment noted that she was currently on comfort measures and a feeding

tube and had “uncontrolled vomiting.” P.
September 4, 2007, noted that her “G-tube
nausea/vomiting,” and the instruction was

Ex. 11. A physician’s telephone order from
[was to] remain clamped — unclamp for
placed in the medication record. P. Ex. 19 at

3; P. Ex. 20 at 5; see CMS Ex. 23 at 63. A physician’s telephone order from September
2, 2007, noted that she was to receive Phenergan intramuscularly every six hours as
needed, and the order was placed in the medication record. P. Ex. 19 at 2; P. Ex. 20 at 9.
Physician orders also note that she had an as needed (PRN) order for oxygen, which was
never administered. CMS Ex. 23 at 20, 24, 71.

Resident 1’s nurse’s notes, from August 31, 2007 to September 16, 2007, reveal:
complaints of pain or discomfort or taking pain medication; complaints of nausea and/or
vomiting; and complaints of crying and anxiety. P. Ex. 20 at 1-2, 10; CMS Ex. 23 at 47-
56. Nurse’s medication notes, and the medication record between September 4 through
September 16, indicate that Phenergan was given for nausea, and Lortab and Darvocet
were given for pain. Id.
Nurse’s notes and physician telephone orders indicate that on September 1, 2007,
Resident 1 was sent to St. Mary’s Hospital for evaluation. Physician’s telephone orders
note that Resident | was sent to the emergency room (ER) on September | to be
evaluated. P. Ex. 19 at 1; CMS Ex. 23 at 41, 55. On September 3, 2007, she was sent to
St. Mary’s Hospital by LPN Miller because she was vomiting brown liquid, and
Phenergan was not effective. Her husband was notified, and EMS was called. CMS Ex.
23 at 54. Nurse’s notes prepared by ADON Moceri on September 4, 2007, state:

Telephone Call to Brenda Gauzet @ Select Specialty .... Stated nausea/vomiting
chronic problem for months. Prognosis for this resident is good. However will be
continual issue [with nausea and vomiting].

CMS Ex. 23 at 53. ADON Moceri testified that she placed the call, because Resident 1’s
husband stated that he preferred that the resident not be sent to the hospital for nausea and
vomiting because it was a chronic condition. He provided the names of the nurse at the
transferring facility and the physician who had performed Resident 1’s surgery to ADON
Moceri, so that she could call them for confirmation of Resident 1’s condition. The nurse
at the transferring facility confirmed to ADON Moceri that Resident 1’s condition was
chronic. ADON Moceri understood by the nurse’s use of the term “good” to describe
Resident 1’s prognosis that the resident was “stable” and that her condition was “as good
as it gets,” not that the resident would get better (a view also held by Surveyor Cox). Tr.
116-17; 199-203; see Tr. 105-10, 359-62, 375. ADON Moceri also spoke to the
resident’s surgeon, who told her that to deal with nausea and vomiting they were “to
leave the tube clamped, the gastric tube clamped. And were she to become nauseated or
start vomiting we were to unclamp the tube to relieve the pressure.” Tr. 201-03. ADON
Moceri noted in the Medication Administration Record (MAR) that Resident 1’s husband
had requested she not be sent to the hospital for just nausea and vomiting, because it was
a chronic condition. In addition, she referred the nurses to the physician telephone order,
which indicated the gastric tube was to remain clamped; however, the tube should be
unclamped for nausea and vomiting and then flushed with water. Tr. 202-03; P. Ex. 19 at
3; see Tr. 293, 313. Ms. O’Brien testified that documenting such advice on the MAR
represents a customary method of assuring that nursing staff is aware of it. Tr. 362; see
Tr. 107-08, 115, 118-19.

On September 10, 2007, Resident 1 was sent to the hospital to have a stitch replaced in
her gastric tube. CMS Ex. 23 at 50. Nurses who interacted with Resident 1 during her
stay, ADON Moceri, LPN Klein, and LPN Miller, testified credibly and consistently with
regard to Resident 1’s baseline condition. ADON Moceri, who was familiar with the
resident, testified that she was chronically ill, had chronic nausea and vomiting, some
confusion, anxiety, and would often call out. She wanted people to stay with her and
calm her down. She was basically bed bound. While she was aware of her surroundings,
she was unrealistic in her expectations of getting better. Instead of using the call light,
she would “holler” for help. She would speak in an anxious, consistently loud voice. Tr.
195-97, 209, 216-17.
LPN Klein, who cared for Resident 1 on the day shift, testified that Resident 1 was on her
call light with a lot of complaints. She was very sick. She complained that her stomach
and back hurt. She complained of nausea and vomiting daily. She would receive pain
and nausea medication. And, if she was complaining of abdominal pain and nausea, they
would unclamp her drainage tube to let the gastric fluid come out and then clamp it back.
This would relieve the gas pressure. The clamping and unclamping was done multiple
times per day. LPN Klein stated that when the resident was nauseous she would be
highly anxious and push her call light more often than usual — even before the nurse left
the door. Her anxiety level was high. She also got confused. She would think she was at
home. She would ask for her husband to visit her when he could have left five minutes
before. She did not appear to be aware of the seriousness of her condition. She would
ask to go home and, five minutes later, she would “be saying she’s sick and she needs to
go to the hospital.” It was typical of her to ask to go to the hospital or to say she was
dying. Her tone of voice changed throughout the day. She would call out in a loud
voice. She would scream, “[c]ome here. Come here.” And, if she saw LPN Klein going
down the hall, she would say in a loud voice, when upset, “[h]elp me, I’m sick.” LPN
Klein once grabbed Resident 1’s hand, because Resident | kept saying “come here,”
when LPN Klein was right beside her to let Resident 1 know she was there. Tr. 220-24.
LPN Klein testified that Resident 1 required a lot of attention and was very vocal. Tr.
225. LPN Klein gave her pain medications. Tr. 229. LPN Klein testified that Resident 1
was the loudest patient on her unit. Tr. 231.

LPN Miller testified that she took care of Resident | on the night shift. She described the
resident as constantly nauseated and vomiting. Resident 1 complained about her stomach
(that it hurt, mostly gas). She had trouble sleeping and was confused at times. By
confused, LPN Miller means she would not always know that she was in a nursing home
and would think she was at the hospital. She wanted a lot of attention and was more
comfortable when someone was with her. She wanted LPN Miller to be with her. She
had a drain tube and a feeding tube (with which LPN Miller testified that she had
experience). Tr. 289-291.

LPN Miller testified that on the night of September 2 and 3, 2007,° Resident 1 started
vomiting what looked like the substance that was in her drain tube. LPN Miller thought
something was backing up. LPN Miller testified she believed that the vomiting in this
instance was a change in Resident 1’s condition necessitating a call to her physician. She
then called Resident 1’s physician’ who told her to send the resident to St. Mary’s
Hospital in Knoxville, where Resident 1 had her surgery, because he felt they would
know more about her condition. The following day ADON Moceri put a note in the

° Night refers to two days, in that the night shift starts at 11:00 p.m. on one day and goes
to 7:00 a.m. the next.

7 LPN Miller did not call Resident 1’s husband. Tr. 312.
10

medication record telling the nurses not to send Resident | to the hospital for nausea and
vomiting, because that was to be expected (unless the nausea and vomiting was
uncontrollable). The resident continued to complain about nausea, vomiting, and pain
every night. LPN Miller would give her a Phenergan shot intramuscularly in the hip to
treat the nausea and vomiting and unclamp her drain tube, which brought her more relief
than anything else. LPN Miller was aware that Resident 1 had orders for the pain
medication Lortab (also known as Hydrocodone) and Darvocet. As well as relieving
nausea, Phenergan can make an individual sleepy. Tr. 291-95, 312-13. Although she
testified that Resident 1 could have more than one pain medication at a time, LPN
Miller’s experience with Resident 1 was that burping her bag gave her more relief than
pain medication. Tr. 302. The resident might not ask for pain medication every night,
but she did ask for Phenergan. It was normal for her to be nauseous, vomiting, and
experiencing pain as gas on her stomach, which was better alleviated by unclamping the
gastric tube than by pain medication. Tr. 319.

Surveyor Cox testified at hearing that LPN Miller is entitled as a nurse to make a
judgment as to the effectiveness of the interventions she takes to address a resident’s
pain. Tr. 137. Surveyor Cox also testified that any analysis of a resident’s change of
condition must take into account that resident’s clinical baseline. Tr. 99-100.

b. The care that was provided to Resident 1 by Petitioner’s staff
during the night of September 16 — 17, 2007.

CMS’s deficiency citations involve the care provided to Resident | by Petitioner’s staff
on the night of September 16-17, 2007. Surveyor Cox’s testimony was that the citations
were even more narrowly focused on the last few hours of Resident 1’s life on September
17, 2007. Tr. 40-41, 120. Specifically, CMS asserts that beginning at 12:00 a.m. on
September 17, 2007, Resident 1 was observed to be nauseous and vomiting. She was
given a shot of Phenergan. An hour later, she was still vomiting and requested her
husband be called and that she possibly be sent to the ER. The husband requested that
she be observed to allow the Phenergan to work but requested that the facility call back if
her condition did not improve. While Resident 1’s vomiting subsided, she continued to
complain of nausea for the next several hours. At 3:00 a.m., she was found in bed with
no heartbeat. She was not breathing and was later pronounced dead. CMS Br. at 10;
CMS Ex. 23 at 47, 49. Her death certificate lists her cause of death as failure to thrive
due to, or as a consequence of, a perforated duodenal ulcer with sepsis. P. Ex. 22.

Nursing notes beginning at 12:00 a.m. on September 17, 2007, prepared by LPN Miller,
relate that:

12A c/o nausea & vomiting. Gave Phenergan I.M. Resident laying in bed [with]
head [up]. Will cont. to monitor.
11

1:00 A Resident still c/o vomiting & nausea. Wants me to call husband and
maybe send to JMH ER. Talked to Gene, husband, says “let’s give the phenergan
a little longer and see if it helps.” Asked me to call back if I need him or if she
doesn’t get to feeling better. Told him I would.

1:30 AM Resident still c/o nausea. Not vomiting as much. Anxious, gave PRN
med for anxiety and restlessness. Husband called back to see how she was. Told
him she was still c/o nausea but not vomiting as much. Resident trying to go to
sleep.

2:00 AM Resident not vomiting any more. Still shows anxiety, wants someone in
room [with] her. Told her we would keep checking on her.

2:00 AM Assured her we would be here all night and that I was just down the hall.
If she put her light on I could see it.

2:15 AM Warren Stinson DDS here visiting [with] Resident.

2:40 AM Resident still c/o nausea. No vomiting. Seems to be calmer. Asks for
cold wash cloth for her head. Told her I would keep checking on her.

3:00 AM Resident found in bed [with] no heart beat and no respirations.
CMS Ex. 23 at 47, 49.

Earlier that evening, at 8:00 p.m., prior to LPN Miller’s shift, Resident 1 had been given
Hydrocodone for pain. It is not disputed that the resident could not receive more
Hydrocodone for six hours. Tr. 131. It is also not disputed that Petitioner was visited by
Warren K. Stinson, D.D.S., on the night in question. Dr. Stinson was in the facility to
care for another resident.* Dr. Stinson knew Resident 1 socially and had visited her at
least three times in the facility. Tr. 392-93. Dr. Stinson testified that he and his wife
visited her that night for “at least 15 minutes.” Tr. 394. Dr. Stinson testified that
Resident 1 spoke to him and told him “[w]hy don’t you hush?” when he was talking to
her. Jd. Dr. Stinson testified that she was not screaming, but she was nauseated and
vomited. Tr. 395. Dr. Stinson did not hear her begging to go to the hospital. She asked
for a “cold rag” for her head, and she received it. She told the staff “[t]hat’s not cold
enough. Make it colder.” Staff wet the washcloth again. Dr. Stinson held the vomit pan
for her. After she “got through throwing up,” he stayed for a few more minutes and left.
Dr. Stinson testified that Resident 1 told him her stomach hurt. He also testified that
Resident 1 was asking for pain medication (Lortab, which is also known as

* Dr. Stinson testified that he visits the facility late at night, stating, “I pay $8,000 a
month in alimony, so I work day and night to pay all that.” Tr. 394.
12

Hydrocodone), and LPN Miller told her she had received Hydrocodone and could not
have more at that time. Dr. Stinson testified that he could not believe she had lived as
long as she had. She had tubes with green drainage coming out of her. He understood
the tubes could be opened up if she got sick. He testified, “I didn’t know she was going
to die 10 minutes later, no.” Tr. 395-97, 398.

CMS bases the deficiencies in this case not on what is documented in the nursing notes,
but on, what Surveyor Cox asserts, was not documented that night. Principally, CMS
bases the deficiencies on the care LPN Miller provided to Resident 1, and the assertion
that Resident 1 was screaming and begging to go to the hospital but was not sent out. Tr.
130, 140. Surveyor Cox based her opinions regarding Resident 1’s condition and
experiences that night almost entirely on her interviews of a Certified Nurse Assistant
(CNA) caring for Resident | that night, Ashley Samples, and an LPN, Robin Campbell,
who was not assigned to care for the resident and who it is not clear ever actually saw the
resident. Tr. 122-23. Ms. Cox also based her opinion on the fact that a 911 call was
made to emergency services that night by another resident. The interviews with CNA
Samples and LPN Campbell took place several months after the incident in question, and
the interview with CNA Samples was by telephone only. Petitioner has portrayed CNA
Samples as a young, inexperienced CNA who was not competent to assess whether a
resident was suffering a change in condition. She had never witnessed a resident die, and
she quit Petitioner’s employ the day after the incident in question for reasons that remain
unclear.” Surveyor Cox does not dispute this, responding to a question regarding CNA
Samples’ credibility by asserting only that “any person, be them trained or not, would
know enough to know if a resident is crying, screaming, and begging to go to the
hospital.” Tr. 125-28. LPN Campbell was not responsible for Resident 1’s care, and
Surveyor Cox does not know whether she actually observed Resident | on the night in
question. Tr. 122-23. As neither CNA Samples nor LPN Campbell testified before me, I
have no way to gauge the credibility of their statements to Surveyor Cox. Although
hearsay is admissible in administrative hearings, I must weigh whether the hearsay is
corroborated by other evidence in the record as a whole to determine the weight I should
give it. Gateway Nursing Ctr., DAB No. 2283 at 5-7 (2009). As discussed below, I give
the hearsay statements of CNA Samples and LPN Campbell little or no weight.'°

° CMS’s assertion that she quit because she was afraid of retribution from LPN Miller is
not persuasive, as there is nothing in the record to suggest that an active investigation of
the incident in question had been undertaken at the time CNA Samples quit.

' Petitioner offered the transcript of a state administrative hearing in this case as P. Ex.
36. CNA Samples testified at this hearing, as did other witnesses who testified before
me. I do not rely on the state administrative hearing transcript. CMS did not cite to the
state transcript to point out inconsistent statements, or otherwise discuss the transcript in
its brief.
13

Surveyor Cox also relied on the fact that a review of a local emergency call log recorded
a 911 call from another resident of Petitioner’s facility at 11:34 p.m. on September 16,
2007. See surveyor notes at CMS Ex. 21 at 33. It is unclear why the other resident made
the call. Petitioner offered to submit a tape of the call in evidence, to which CMS
objected. As the tape was offered at hearing, long after the date for the parties to have
exchanged exhibits, I sustained CMS’s objection and did not admit the tape as an exhibit.
Tr. 403. Thus, I do not know what the resident actually told the 911 operator. The fact
that the call was made, however, does not indicate that the resident was not receiving
care, or that her condition substantially changed. The call does not establish or bolster
CMS’s case.

CMS asserts, however, that the resident who made the telephone call to emergency
services stated that Resident 1 had been screaming for a nurse (although, as noted, since I
have not heard the tape, I have no ability to know exactly what the resident who made the
call actually said). See Tr. 403. It is undisputed that the 911 operator subsequently
contacted the facility and spoke with LPN Campbell. CMS references Surveyor Cox’s
testimony that LPN Campbell walked over to Resident 1’s unit to investigate. Tr. at 58.
Surveyor Cox testified that LPN Campbell told her Resident 1 was complaining of
stomach pain, crying, and begging to go to the hospital. CMS Br. at 10, 13; Tr. 58. CMS
references a written statement drafted by LPN Campbell on January 16, 2008, at
Surveyor Cox’s request, and written in the surveyor notes, in which LPN Campbell
relates,

I told Shirley 2 or 3 times that she needed to send the resident to the hospital. One
time in particular was when Shirley came down to Unit | and said “She is getting
on my [expletive deleted] nerves” and I told her well if nothing else send her out
so you don’t have to hear her. Shirley also waited until Karen Moceri came in that
morning to chart on resident. I read the chart after the documentation had been put
in that morning and it did not reflect what had truly happened . . . Shirley did not
relate fully what was going on to the resident’s husband or he would probably
have sent her out. When Shirley documented that the resident was trying to get to
sleep that was not true. She was crying and screaming the whole time I was down
there. Shirley had not wrote down the times of anything because I asked her about
it and she said she hadn’t that she was waiting on Karen to come in that morning.

CMS Ex. 21 at 45. However, as noted above, LPN Campbell did not testify. LPN
Campbell did not tell DON Williams any of this at the time. Tr. 279-80. I give LPN
Campbell’s written statement no weight. While she indicates she “told” LPN Miller to
send the resident to the hospital, the evidence does not establish that she saw or treated
the resident or was ever in the room with the resident. While she indicates that the
charting done the next day on the resident’s chart did not reflect what truly happened, she
did not testify to what “truly” happened. Moreover, there is no evidence that at the time
of the incident LPN Campbell related what “truly” happened to anyone at the facility. Tr.
279-80.
14

CMS asserts that the CNA assigned to Resident | on the night of her death, CNA
Samples, stated in a telephone interview with Surveyor Cox that Resident 1 was on her
call light for the whole night, complained of pain in her stomach, and was vomiting.
CMS Ex. 21 at 30; CMS Br. at 10; Tr. 45. Surveyor Cox related that CNA Samples told
her that the resident complained of trouble breathing, but the CNA could not get an
oxygen saturation level. Her fingers were turning blue. LPN Miller told CNA Samples
that Resident 1 could not have oxygen, because they could not obtain her oxygen
saturation level. Jd. CNA Samples stated she told LPN Miller that the resident wanted to
go to the hospital and wanted her husband to be called. CNA Samples asked LPN Miller
whether she should check Resident 1’s vital signs, but was told it was unnecessary. Id.
CNA Samples attempted to report her concerns to the DON and ADON but was rebuffed,
because they were too busy to speak with her. CMS Br. at 10-11; CMS Ex. 21 at 30.
CNA Samples left her job shortly after Resident 1’s death. CMS Br. at 11; CMS Ex. 21
at 31. As noted above, CNA Samples did not testify, so I have no way to gauge the
credibility of the statements she made by telephone to Surveyor Cox several months after
the event in question. Although CNA Samples allegedly indicated to Surveyor Cox that
she attempted to report her concerns to the DON and ADON, there is no evidence that if
she was so concerned about what happened that night that she persisted in doing so.

CMS asserts that LPN Miller, who was assigned to care for Resident | on the night of her
death, called Resident 1’s husband on September 17, 2007, and asked if he wanted the
resident sent to the hospital. Resident 1’s husband did not want her sent to the hospital,
and he asked LPN Miller to wait and see if Phenergan relieved Resident 1’s nausea.
Resident | had been sent to the hospital the week before and the husband did not want
her to be sent back for nausea and vomiting. CMS Ex. 21 at 36-37; CMS Br. at 11; Tr.
53. Surveyor Cox testified that LPN Miller told her it was not uncommon for the resident
to be vomiting and nauseous and that if she had taken vital signs they would be in the
nursing notes. Jd. LPN Miller did not give the resident pain medication, despite her
complaints of pain. LPN Miller admitted that DON Williams should be contacted
regarding a request to go to the hospital. Resident 1’s physician was not contacted
regarding her complaints of pain, vomiting, and nausea, as well as a transfer request. Id.
Surveyor Cox testified that nurse’s notes from that night did not list any vital signs or
documentation regarding vital signs. Tr. 57.

LPN Miller, the only individual who testified before me that actually had direct contact
with the resident that night (other than Dr. Stinson), testified credibly and consistently on
both direct and cross-examination. She testified consistently with the nurse’s notes she
prepared that night. LPN Miller testified that she worked the 11:00 p.m. to 7:00 a.m.
shift five days a week while Resident | was at the facility and had 60 residents under her
care the night of September 16-17, 2007. Tr. 289, 319. She testified that on the night in
question she came on duty around 11:00 p.m. At about 11:30 p.m. or 12:00 a.m., the
CNA came to tell her Resident 1 was vomiting. LPN Miller went to see her, and she

15

appeared “[a]bout the same as she was every day.”'! Tr. 295. She appeared mentally

about the same as she was every day. LPN Miller asked the resident if she wanted a
Phenergan shot and gave the shot to her. She gave the resident a cold rag to put on her
head (because a cold rag makes a person feel better when vomiting). Phenergan can
make a person sleepy, and the resident was having trouble sleeping. Resident 1 was not
expressing different complaints of pain, or of pain in parts of her body, other than those
that she usually complained about. She was not complaining of chest pain, did not have
trouble breathing, and her fingers were not turning blue. Her hands were cold, but that
was not unusual. When the resident complained of discomfort in her stomach, LPN
Miller unclamped her drain tube a couple of times, burping the bag once to let the gas out
of the bag. This gave the resident some relief. Tr. 294-98, 313, 319.

LPN Miller testified that Resident 1 asked her to call her husband and see if maybe he
would send her to the hospital. LPN Miller had been told not to send the resident out for
nausea and vomiting. The resident was not begging to go to the hospital or screaming in
pain. LPN Miller called the husband about Resident 1’s request to go to the hospital, and
Resident 1’s husband asked LPN Miller to give the Phenergan time to work. LPN Miller
testified that seemed like a reasonable suggestion. The Phenergan did seem to work. The
resident calmed down. She was resting and trying to go to sleep. The husband later
called back and LPN Miller told him that she was still complaining of nausea, but was
not throwing up like she had been and was resting better. The husband seemed satisfied.
LPN Miller testified that in her opinion the resident “was doing a whole lot better.” Tr.
298-99; see Tr. 281-82.

LPN Miller testified that LPN Campbell came to her unit to report that a resident across
the hall had called 911. LPN Campbell relayed to her that apparently the resident heard
someone hollering for help, and no one was answering her. LPN Miller testified that she
was coming out of Resident 1’s room when LPN Campbell arrived. LPN Campbell let
LPN Miller know that the call had been made and that LPN Miller needed to call
“dispatch back.” LPN Campbell did not express alarm or concern over the resident’s
condition, and LPN Miller does not recall LPN Campbell going into the resident’s room.
The resident was not screaming at the time. The resident was saying “help,” but that was

" During cross-examination, CMS counsel asked LPN Miller whether it was “not a big
deal that [Resident 1] was complaining of nausea, vomiting, and pain.” Tr. 319. In its
brief, CMS counsel asserted that LPN Miller thought the resident’s complaints were “no
big deal” and inferred as a result of that phrase that LPN Miller grossly failed in her care
and allowed Resident 1 to needlessly suffer in severe pain during her last hours of life.
CMS Br. at 18. The terminology of “no big deal” was CMS counsel’s, and the question,
in context, refers more to LPN Miller’s testimony that it was normal for the resident to be
nauseous, vomiting, and experiencing pain “as the gas on her stomach” than it does to
whether or not LPN Miller was callous towards Resident 1’s complaints on the night in
question. Tr. 319.
16

normal for her, as was testified to also by LPN Klein. LPN Miller returned the 911 call
to tell them that she was in the resident’s room at the time the other resident placed the
call. LPN Miller let the resident who placed the call (who could not see into Resident 1’s
room as the door was shut) know that the resident was just upset, wanted someone with
her, and LPN Miller was there. Tr. 224, 299-301, 315-18, 320.

LPN Miller testified that she spoke with Dr. Stinson in Resident 1’s room. He was
talking to Resident 1 about their past relationship. He did not express any concern or
alarm to LPN Miller about the resident’s condition or appearance. Tr. 301-02.

LPN Miller testified that Resident 1 did ask her for pain medication. LPN Miller checked
the MAR and saw it was not time for that pain medicine. While Resident 1 could have
had two medications, she had the stronger one, and it was not helping. LPN Miller stated
she could have had more than one medication at a time. However, it was LPN Miller’s
experience that burping the resident’s bag brought her more relief than the pain medicine.
And, she had already had pain medication, and it was not really helping. So LPN Miller
burped the bag, which appeared to help, and gave Resident 1 Phenergan, which appeared
to also help. LPN Miller did this, because it was “something we done just about every
night.” Tr. 302-03. LPN Miller testified that at no point during the night did she feel the
resident should be sent to the hospital. LPN Campbell told her to send the resident to the
hospital, “[b]ecause she was on her light so much that night keeping us busy in her room
all night. She said it would be easier just to send her out and get rid of her.” LPN Miller
said she could not do that, since they are not supposed to do that. Tr. 303.

LPN Miller testified that CNA Samples had not been a CNA very long and had never had
“anybody pass away while she was working.”” CNA Samples did not tell LPN Miller that
she saw symptoms she considered to be new, unusual, or very serious. Tr. 304

LPN Miller testified that they tried to take the resident’s oxygen saturation level, but
Resident 1 did not keep her hands still long enough for them to get it. For the monitor to
register, an individual must keep his or her hands still so the device can be clamped on
the individual’s finger. LPN Miller testified that she was only trying to measure the
Resident 1’s oxygen saturation level to calm her down, as the resident was not exhibiting
symptoms of a lack of oxygen. LPN Miller was just doing different things to show the
resident she was there. Tr. 304-05.

LPN Miller charted the events of the night in question at the end of her shift. Tr. 324.
She did not chart that vital signs were checked. She noted that she gave the resident
Phenergan, and she also gave the resident something for anxiety. Jd.

LPN Miller testified that she let ADON Moceri know that the resident had passed away
and that there had been a 911 call. LPN Miller does not recall telling her the resident had
requested to go to the hospital. LPN Miller did not mention that the resident was
expressing some pain, because LPN Miller did not consider it a change of condition.
17

LPN Miller testified that the nursing administrators reviewed Resident 1’s chart and
found nothing unusual. She was not threatened with disciplinary action; and there was
no reason for her to make any threats against CNA Samples. LPN Miller testified that
she did not have a good reputation with the CNAs, because she wanted them to do their
jobs and some were “kind of lazy.” Tr. 306-07. LPN Miller testified she quit after her
suspension after the January Survey, because she was upset, needed to make a living, and
the suspension was without pay. Tr. 307-09, 325.

c. Petitioner was in substantial compliance with 42 C.F.R.
§ 483.10(b)(11) (F Tag 157).

The regulation at 42 C.F.R. § 483.10 governs resident rights. Subsection
483.10(b)(11)(B) requires that a facility must: immediately inform the resident; consult
with the resident’s physician; and if known, notify the resident’s legal representative, or
an interested family member, when there is significant change in the resident’s physical,
mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial
status in either life-threatening conditions or clinical complications). As the Board noted:

... the regulation does not limit the term “significant change in . . . status: to mean
only a “life threatening condition,” nor does it equate the term “significant
change” with “medical emergency.” . . . Rather the regulation directs the facility to
consult with the physician immediately not only where a resident’s “significant
change” is in a “life-threatening” condition, but also when the change involves
non-emergency clinical complications such as the development of a stage II
pressure sore, the onset of delirium, or a need to alter treatment significantly.

Laurels at Forest Glenn, DAB No. 2182 at 12 (2008). The Board also observed that the
preamble introducing the final rule, as well as prior Board decisions, addressed the role of
professional nursing judgment

The regulatory history acknowledges that nursing judgment may be involved in
evaluating what is significant for a particular resident, gives examples of “life
threatening conditions” (heart attack and stroke), and supports a conclusion that
the potential need for physician intervention in whether notice is required.”

Id. at 13-14, quoting Park Manor Nursing Home, DAB No. 2005 at 29 (2005), aff'd,
Park Manor, Ltd. v. U.S. Dep’t of Health & Human Servs., 495 F. 3d 433 (7th Cir. 2007);
see also Park Manor Nursing Home, DAB No. 1926 (2004).

® Tnote that LPN Miller received disciplinary warnings. The warnings do not impeach
the credibility of her testimony, nor does testimony concerning action against her nursing
license as a result of this incident. Tr. 322-23, 326; CMS Ex. 18.
18

CMS asserts that Petitioner had a policy that required nursing staff to notify a resident’s
physician and family member/legal representative when a resident had a significant
change in physical, mental or emotional status. CMS Ex. 34 at 1-2. The policy also
recorded that all changes in a resident’s medical condition needed to be properly reported
in the resident’s medical record. Jd. at 2. CMS asserts that because LPN Miller did not
recognize Resident 1’s pain complaints, ongoing nausea, and vomiting as a change in
condition, she did not contact the resident’s physician (although she did contact the
resident’s husband). Further, CMS asserts that the nurse’s notes contained no
information related to the significant condition change on the night of September 17,
2007, other than about the resident’s death. CMS Br. at 19-20.

I find that Petitioner did not suffer a change in her baseline condition such that her
physician was required to be notified. CMS asserts that what constituted Resident 1’s
change in condition were her complaints of pain, ongoing nausea and vomiting.
However, these were the exact complaints that the nurses, who actually knew and treated
Resident 1, asserted occurred daily, while testifying before me. ADON Moceri testified
that the resident had chronic nausea and vomiting and wanted people to calm her down.
According to LPN Klein, Resident 1 would “holler” for help. LPN Klein testified that
Resident 1’s stomach and back hurt and, she complained of nausea and vomiting daily.
She would call out in a loud voice. LPN Miller testified she was constantly nauseous and
vomiting and said her stomach hurt. LPN Miller did contact the physician and sent the
resident to the hospital, when she saw what she believed to be change in Resident 1’s
condition on the night of September 2-3. Specifically, she noticed the resident was
vomiting brown liquid, and the Phenergan was not effective. After Resident 1 was sent
back to the facility, the nurses were told the resident’s condition was chronic, and the best
way to deal with her chronic condition was to unclamp the gastric tube. Dr. Stinson did
not describe a resident who was screaming or begging to go to the hospital. The weight
of this testimony, balanced against the evidence submitted by CMS on this point
(surveyor notes prepared by Surveyor Cox delineating her conversations with LPN
Campbell and CNA Samples several months after the survey and the written statement of
LPN Campbell), leads me to conclude that Resident 1’s baseline condition was
unchanged on the night of September 16-17, 2007.

d. Petitioner was in substantial compliance with 42 C.F.R. §§ 483.13(c)
(F Tags 224 and 226).

42 C.F.R. § 483.13 governs resident behavior and facility practices. Further, 42 C.F.R. §
483.13(c) references staff treatment of residents. It states:

The facility must develop and implement written policies and procedures that
prohibit mistreatment, neglect, and abuse of residents and misappropriation of
resident property.
19

Section 488.301 defines “neglect” to be the “failure to provide goods and services
necessary to avoid physical harm, mental anguish, or mental illness.”

The statement of deficiencies asserts that Petitioner violated F Tag 224, because it failed
to assess and control the resident’s pain, assess the resident’s vital signs, and honor the
resident’s request for a transfer to the hospital. CMS also alleges that Petitioner violated
F Tag 226 by failing to thoroughly investigate an allegation of neglect. As a result, both
violations placed Resident 1 in immediate jeopardy. P. Ex. 1 at 8, 17.

In its briefing, CMS argues specifically that Petitioner failed to recognize that the
incidents preceding Resident 1’s death might indicate possible resident neglect. By
applying the facility’s definition of neglect within its neglect abuse policy,'* LPN Miller
failed to acknowledge or address that Resident 1’s repeated ongoing complaints of severe
abdominal pain and nausea constituted a failure to ensure that Resident 1 did not suffer
needless hours of physical and mental anguish prior to her death. In failing to recognize
the incident was one of possible resident neglect, Petitioner failed to trigger and
implement its neglect investigation policy. CMS Br. at 11-14.

While CMS admits that the incident was correctly reported to the DON and ADON the
day after the incident, CMS maintains that several other requirements were not
implemented: the nurse’s notes did not have any information related to Resident 1’s vital
signs; no incident report was completed, and no witness statements provided to Surveyor
Cox; and Resident 1’s physician was not contacted. CMS Br. at 14. Surveyor Cox’s
testimony indicates that the DON was not notified of any of the incidents related to
Resident 1’s death until after her death. See Tr. 64-65. CMS asserts that the extent of
DON Williams’ investigation was a chart review performed by DON Williams and a
corporate nurse consultant. Tr. 65. No witness statements were provided when Surveyor
Cox requested them. Tr. 65, 69-72.

All of CMS’s arguments presuppose that the care provided by LPN Miller constituted
neglect. CMS did not establish, however, that Petitioner neglected Resident 1. The
evidence establishes that LPN Miller was providing the required and appropriate care in
providing nausea medication, anxiety medication, and releasing the clamp to Resident 1’s
gastric tube to provide pain relief. Ms. O’Brien,"* the only expert in long term nursing

® Petitioner’s policy and procedure manual defines resident neglect as “[t]he failure to
provide goods and services necessary to avoid physical harm, mental anguish, or mental
illness.” CMS Ex. 29 at 1.

'“ Ms. O’Brien testified that she reviewed Resident 1’s medical record at the facility, as
well as Tennessee regulations. She researched perforated ulcers. She was also sent the
facility’s plans of correction and the transcript of the state hearing. Tr. 337-38. She was
not provided witness statements prepared at the time of Surveyor Cox’s survey. Tr. 379-

(continued...)
20

care offered by the parties, testified that LPN Miller’s interventions and judgments that
night met the nursing standard of care. Ms. O’Brien testified that LPN Miller’s care of
the resident was positive. She had control of the situation, was not panicked, and had
other staff around her. Tr. 344-45, 370-71. Ms. O’Brien also testified with regard to
whether vital signs should have been taken. Ms. O’Brien testified that night shift vital
signs are usually taken in the morning, unless there is a change of condition, which Ms.
O’Brien testified Resident 1 was not experiencing. Tr. 366-67. Although Surveyor Cox
testified that Petitioner’s policy was to check vital signs when a resident is complaining
of pain, it does not require that they be documented. Tr. 153-54. DON Williams testified
that vital signs are included when there is a change of condition. Tr. 267. While the
DON conceded that LPN Miller’s documentation had problems, nothing in the chart, or
in her conversation with LPN Miller the morning Resident 1 passed away, alarmed her.
The resident had a chronic condition, and it was not shocking that she had passed away.
Tr. 258-60.

Further, Petitioner did not fail to investigate an incident of neglect. Following state
review after the resident’s death, no citation against the facility or deficiency was found.
There was no allegation of neglect and nothing to further investigate. DON Williams and
ADON Moceri did a routine chart review and spoke with the nurses on duty (with the
exception of CNA Samples, who chose not come back to work). The nurses told
Surveyor Cox that they saw nothing suspicious. Tr. 155, 158, 258-59.

e. Petitioner was in substantial compliance with 42 C.F.R. §§ 483.20,
483.20(b), and 483.20(k)(3)(i) (F Tags 272 and 281).

42 C.F.R. § 483.20 references resident assessments and requires a facility to conduct
initially and periodically a comprehensive assessment of a resident’s functional capacity.
42 C.F.R. § 483.20(b) references comprehensive assessments, and 42 C.F.R. §
483.20(k)(3)(i) references comprehensive care plans. Specifically, the services provided
or arranged by the facility must meet professional standards of quality. The statement of
deficiencies cited the deficiency at F Tag 272 at a scope and severity level of D and
asserted that Petitioner failed to assess Resident 1’s complaints of pain and vital signs.
The statement of deficiencies at F Tag 281 cited a deficiency at a scope and severity of
level J and asserted that Petitioner failed to document and medicate for complaints of
pain, assess Resident 1’s vital signs, and notify Resident 1’s physician of the resident’s
pain and request for a transfer to the hospital. P. Ex. 1 at 21-27.

4 (...continued)

80. However, as noted above, I have given little or no weight to the statement of LPN
Campbell, which CMS relies upon to make its case.
21

CMS asserts specifically that LPN Miller failed to meet a professional standard of care as
to Resident 1 based upon her failure to address Resident 1’s repeated complaints of
abdominal pain and nausea on September 17, 2007. Further, CMS asserts that LPN
Miller did not make any entries in Resident 1’s nursing notes contemporaneously
(instead, she filled them in at the end of her shift). CMS asserts that LPN Miller’s LPN
license was suspended as a result of her role in this incident, pending her completion of a
refresher course. CMS Br. at 15-16. CMS asserts, without first establishing what the
standard of care is, that LPN Miller’s care fell below a professional standard of care,
because she failed to properly assess Resident 1’s complaints of pain and failed to
provide pain control. According to CMS, her “haphazard” charting also exposed
Resident | to substandard quality of care. CMS asserts that even with her colleagues
urging her to transfer Resident | to the hospital, due to the resident’s persistent pain
complaints and cries for assistance, LPN Miller did “absolutely nothing to aid Resident
1.” CMS Br. at 16.

I note initially that the deficiencies asserted by CMS do not appear to fall under F Tag
272 and that deficiency citation is only at a level D. Therefore, I do not address that
section. With regard to F Tag 281, CMS appears to assert that Petitioner did not provide
services that met professional standards of quality in the care that LPN Miller provided to
Resident 1 on September 17, 2007.

The evidence does not support CMS’s assertions, especially its assertion that LPN Miller
did “absolutely nothing” to aid Resident 1. LPN Miller did address Resident 1’s
complaints of pain and nausea by unclamping the tube and giving the resident
medications. That LPN Miller did not give pain medication at about 2:00 a.m., I accept
as her nursing judgment. CMS does not assert a standard of care that an LPN’s
assessment must be in writing. CMS does not relate how the suspension of LPN Miller’s
license relates specifically to the facts of this case. I accept LPN Miller’s explanation
that she agreed to a suspended license and re-training, because she did not want to go to
court to fight the suspension. Although CMS asserted that LPN Miller should have made
nursing notes contemporaneous with Resident 1’s care, as opposed to charting before or
at the end of her shift, CMS does not cite to a standard of care to make its case. CMS Br.
at 16. Nor does CMS explain what it means by how “haphazard” charting exposed
Resident 1 to substandard quality of care and exactly what the “haphazard” charting in
this case consisted of. Jd. As previously noted, I give no weight to the hearsay
statements and written note prepared by LPN Campbell - that she urged LPN Miller to
transfer the resident to the hospital to aid the resident (as opposed to getting the resident
out of the facility, because she was annoying to staff).

f. Petitioner was in substantial compliance with 42 C.F.R. § 483.25 (F
Tag 309).

This regulation relates to a facility’s quality of care, and provides that each resident must
receive and the facility must provide the necessary care and services to allow a resident to
22

attain or maintain the highest practicable physical, mental, and psychosocial well-being,
in accordance with the comprehensive assessment and plan of care. The statement of
deficiencies alleges that Petitioner failed to alleviate pain for Resident 1. P. Ex. 1 at 27-
30.

CMS references its Guidance for Surveyors in asserting that three factors are to be
evaluated when determining whether to cite a deficiency on the basis of pain control.
These include that a caregiver: (1) recognize when the resident is experiencing pain and
identify circumstances when pain can be anticipated; (2) evaluate the existing pain and
the causes; and (3) manage or prevent pain, consistent with the comprehensive
assessment and plan of care, current clinical standards of practice, and a resident’s goals
and preferences. CMS Br. at 16-17 (citing the SOM, Guidance to Surveyors at 191).
CMS asserts that the SOM requires that effective pain recognition and management
requires an ongoing facility-wide commitment to: resident comfort; identifying and
addressing barriers to managing pain; and addressing any misconceptions that residents,
families and staff may have about managing pain. CMS Br. at 17 (citing SOM at 193).

CMS asserts that Petitioner’s pain management policy's stated goal was to “control
comfort level by altering the perception of pain without producing confusion or
sedation.” CMS Ex. 33 at 8. Surveyor Cox testified that Resident 1 exhibited several of
the behaviors and symptoms of pain noted in the pain management policy. CMS Br. at
18; Tr. 80. Surveyor Cox testified that LPN Cox failed to document whether Resident
1’s pain was assessed and failed to provide Resident 1 with any pain medication, despite
the fact that Resident 1 had physician orders for at least two pain medications. Id.

CMS notes that LPN Miller testified that it was normal for Resident 1 to complain of
pain, and she often requested pain medication at night. Tr. 319. CMS asserts from this
statement that LPN Miller minimized Resident 1’s pain complaints on September 17,
2007, stating that it was not a “big deal” when the resident complained of stomach pain
and asked to go to the hospital. CMS Br. at 18. CMS asserts that LPN Miller did not
follow the pain management protocol, ignoring Resident 1’s pain, and failed to assess it
or make any additional attempts to alleviate the pain. CMS maintains that LPN Miller’s
gross failure to even acknowledge, or attempt to address, the resident’s pain caused
Resident | to needlessly suffer in severe pain during her last hours of life. Id.

As noted above, CMS counsel, not LPN Miller, introduced the use of the phrase “big
deal.” CMS’s hyperbole aside, the evidence does not show that LPN Miller “minimized”
the resident’s pain. LPN Miller addressed the resident’s complaints of pain, nausea, and
vomiting, by unclamping the gastric tube and giving the resident Phenergan and an anti-
anxiety medication. It is uncontested that the resident was provided pain medication at
8:00 p.m. and could not have more until at least 2:00 p.m. LPN Miller has credibly
testified that Resident 1 had received the stronger pain killer and that it was not working.
It was her testimony, based on her care of the resident, that the resident received more
relief from unclamping the tube than from medication. I find LPN Miller to be credible

23

and accept that it was LPN Miller’s nursing judgment whether and when to give more
pain medication.

g. Petitioner was in substantial compliance with 42 C.F.R. § 483.75 (F
Tag 490).

The regulation in question requires that a facility be administered in a manner that
enables it to use its resources effectively and efficiently to attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each resident. The
statement of deficiencies reflects that: Petitioner was not administered in a manner to
ensure that Resident 1 was free from neglect; the resident’s physician was notified of
changes in the resident’s condition; and the resident’s request for a transfer was not
honored. P. Ex. | at 30-31.

CMS does not address this Tag in its brief, although the Tag was found to be at a scope
and severity level of J. See CMS Br. at 2. As I have otherwise found Petitioner to be in
substantial compliance, I find Petitioner to be in substantial compliance with this F Tag
as well.

2. No remedies are reasonable, because Petitioner was at all times in
substantial compliance with participation requirements.

CMS has painted a lurid portrait of what happened to Resident 1 on the night of
September 16-17, 2007. Specifically, CMS asserts that LPN Miller did nothing to aid
Resident | and allowed the resident to “suffer in excruciating pain for several hours
without any real assistance or relief. . ..” CMS Br. at 23. Resident 1 was certainly a
distressing case. The perforated ulcer she suffered, the unsuccessful surgeries, and the
fact that she suffered from chronic nausea, vomiting, and pain are extremely unfortunate.
In such circumstances, it is incumbent upon a facility to respond immediately and
appropriately to changes in a resident’s condition and to alleviate their pain. It is also
incumbent upon state surveyors and CMS to robustly investigate complaints of neglect.
The evidence of record in this case, however, does not show that the care provided by
LPN Miller to this unfortunate woman was so deficient as to constitute immediate
jeopardy under the deficiencies cited justifying a $1,410,000 CMP. CMS’s case is based
solely on questioning the clinical judgments that LPN Miller made on this one night.
However, LPN Miller had been caring for this resident since she was admitted to
Petitioner’s facility. LPN Miller testified credibly with regard to the resident, her
condition, and the care that the resident received. | am convinced by LPN Miller’s
credible testimony that the most effective response to Resident 1’s complaints that night
was to administer anti-nausea medicine and unclamp her gastric tube. Moreover, even if
I had found a deficiency to exist, CMS has singularly failed to show how the care
provided by this one LPN to this one resident over a three-hour period could in any way
justify a CMP of almost one and a half million dollars.

24

IV. Conclusion

For the foregoing reasons, I find Petitioner was in substantial compliance with
participation requirements at all relevant times and that imposition of any remedies is not
supported by the record.

/s/
Alfonso J. Montafio
Administrative Law Judge