Highland Pines Nursing Home, DAB CR6922 (2026)

DECISION

Highland Pines Nursing Home (Petitioner), a skilled nursing facility (SNF) that participates in the Medicare program, failed to ensure that Resident 1 received foot care in accordance with his care plan.  This prevented prompt identification and response to the gangrene that developed on Resident 1’s right foot.

Based on the results of a complaint survey completed on April 19, 2022, by the Texas Department of Health and Human Services (state agency), the Centers for Medicare & Medicaid Services (CMS) found that Petitioner was not in substantial compliance with Medicare program participation requirement for SNFs at 42 C.F.R. § 483.25 (relating to quality of care) at a scope and severity level J.  CMS imposed a $22,584 per-instance civil money penalty (CMP) for an instance on April 4, 2022.

Petitioner disputes that it was not in substantial compliance and argues that it ensured that the treatment and care provided to Resident 1 was in accordance with his care plan and the professional standards of practice.  Petitioner asserts that nothing it did or failed to do caused Resident 1 to develop gangrene on his right foot.  Petitioner further argues that the CMP imposed was not reasonable.

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As explained below, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 because it failed to ensure that Resident 1 received treatment and care in accordance with professional standards of practice, Petitioner’s policy, and Resident 1’s care plan.  These failures at least posed a potential for more than minimal harm.  Additionally, I conclude that the CMP imposed in this matter is appropriate under relevant statutory and regulatory factors.

I.  Background and Procedural History

Petitioner is a SNF that operates in Longview, Texas.  On April 19, 2022, surveyors from the state agency completed an abbreviated standard survey, which was triggered by a complaint.  CMS Ex. 2.  The state agency subsequently issued a Statement of Deficiencies (SOD).  Id.  The SOD indicated that the survey yielded evidence of substantial noncompliance with 42 C.F.R. § 483.25 (Tag F684) (Quality of Care) at a scope and severity level “J”1  (i.e., isolated deficiency constituting immediate jeopardy to resident health or safety) related to Resident 1.  CMS Ex. 2.  The state agency notified Petitioner in a letter dated May 2, 2022, of its finding of substantial noncompliance and informed Petitioner of the imposition of a denial of payment for new admissions (DPNA), beginning May 17, 2022.  CMS Ex. 1 at 1, 4, 6.

On May 20, 2022, CMS issued an initial determination that Petitioner was not in substantial compliance with Medicare participation requirements with the cited deficiency.  CMS Ex. 1 at 4-7.  CMS imposed a $22,584 per-instance CMP for the instance on April 4, 2022, described at deficiency Tag F684.  Id. at 5.  CMS advised Petitioner that by the May 2, 2022 notice, the state agency notified it of the imposition of a DPNA.  Id. at 6.  CMS also informed Petitioner that unless Petitioner achieved substantial compliance before October 19, 2022, CMS would terminate Petitioner’s

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Medicare provider agreement.  Id. at 4.  The notice did not mention if and how the findings of noncompliance affected Petitioner’s ability to conduct a nurse aide training and competency evaluation program (NATCEP).  See CMS Ex. 1.

By letter dated June 10, 2022, CMS notified Petitioner that it had achieved substantial compliance with the Medicare participation requirements on April 20, 2022.  CMS Ex. 1 at 1.  It further informed Petitioner that the imposed remedies were revised.  Id.  The termination of Petitioner’s Medicare provider agreement was rescinded, the DPNA was also rescinded, and the per-instance CMP remained as imposed.  Id.  The letter also confirmed receipt of Petitioner’s waiver of its appeal rights, which Petitioner subsequently withdrew.  Id. 1, 5; CMS Br. at 2.

On July 12, 2022, Petitioner timely requested a hearing before an administrative law judge (ALJ).  On July 13, 2022, ALJ Bill Thomas was designated to hear and decide this case.  That same day, the Civil Remedies Division (CRD) issued an acknowledgment letter and ALJ Thomas’s Standing Prehearing Order (Standing Order), which, among other things, directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.  In compliance with the Standing Order, CMS filed a combined motion for summary judgment and prehearing brief (CMS Br.) and 10 proposed exhibits (CMS Exs. 1-10).  Petitioner filed a prehearing brief and response to CMS’s motion for summary judgment (P. Br.) and four proposed exhibits (P. Exs. 1-4).  Petitioner also filed objections to three of CMS’s proposed exhibits.  CMS did not file a reply.

Effective May 21, 2026, this case was reassigned to me.

II.  Decision on the Record

Pursuant to ALJ Thomas’s Standing Order, the parties were directed to submit written direct testimony for all witnesses that they wanted to present in this proceeding.  ALJ Thomas’s Standing Order stated that an in-person hearing would only be necessary if a party submits written testimony for a witness and the opposing party requests to cross-examine that witness.  Standing Order ¶¶ 12-13; CRDP §§ 16(b), 19(b).

Petitioner did not offer any witnesses, nor did it submit written direct testimony from any witnesses.  It only submitted unsworn statements by Carl Earnest, MD; Keith Crandall, DPM; and Jerome Watson, APRN.  P. Ex. 2.  CMS submitted written direct testimony for one witness, Surveyor William Flanery, LBSW-IP.  CMS Ex. 8.  Petitioner did not request cross-examination of CMS’s sole witness.  Even if I were to construe the statements offered by Petitioner as written direct testimonies and as an offer of witnesses to be cross-examined, CMS did not request to cross-examine those individuals.  Therefore, I decide this case based on the written record.  Standing Order ¶ 13; CRDP § 19(d).  I deny CMS’s motion for summary judgment as moot.

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III.  Evidentiary Rulings

I admit Petitioner’s four proposed exhibits into the record, without objection from CMS.  I also admit all of CMS’s proposed exhibits into the record.  Below, I explain why I overrule Petitioner’s objections to three of CMS’s exhibits.

Petitioner objected to CMS Exhibits 2, 7, and 8.  Petitioner’s Objections to CMS’s Exhibits (P. Objs.).  Petitioner objects to CMS Exhibit 2, which is the SOD, asserting that it contains “inadmissible hearsay.”  Id. at 1.  Petitioner states that the SOD “contains interviews and statements by staff working at Petitioner’s facility who have not been named as witnesses in this case.”  Id.

In these proceedings, I am to receive into evidence any testimony and documents that are relevant and material.  42 C.F.R. § 498.60(b)(1).  Further, I may receive evidence even if it is inadmissible under the rules of evidence applicable to the courts.  42 C.F.R. § 498.61.  Further, the Administrative Procedure Act provides:

Any oral or documentary evidence may be received, but the agency as a matter of policy shall provide for the exclusion of irrelevant, immaterial, or unduly repetitious evidence.  A sanction may not be imposed or rule or order issued except on consideration of the whole record or those parts thereof cited by a party and supported by and in accordance with the reliable, probative, and substantial evidence.

5 U.S.C. § 556(d).  Therefore, the primary test for the admission of evidence is whether it is relevant and material to an issue in the case.  The SOD is “unquestionably relevant and material evidence.”  Avalon Place Trinity, DAB No. 2819 at 38 (2017).  It is relevant to these proceedings because it sets out the survey findings on which CMS bases its enforcement actions that are the subject of appeal.  Moreover, Petitioner’s objections regarding hearsay evidence are misplaced.  I am permitted to admit and consider hearsay statements in these administrative proceedings even if they would be inadmissible under the rules of evidence applicable to court proceedings.  See 42 C.F.R. § 498.61; Florence Park Care Ctr., DAB No. 1931 (2004).  The Departmental Appeal Board (Board) has recognized that hearsay statements “may be accorded appropriate weight, if supported by adequate indicia of reliability . . . .”  Pac. Regency Arvin, DAB No. 1823 at 15 n.6 (2002).  The weight an ALJ accords hearsay is “determined by the degree of reliability, based on relevant indicia of reliability and whether the hearsay is corroborated by other evidence in the record as a whole.”  Omni Manor Nursing Home, DAB No. 1920 at 17 (2004).  The document is therefore admitted.

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Petitioner also objects to CMS Exhibit 7, which is Surveyor Charles Flanery’s notes, contending that the notes contain inadmissible hearsay, contain irrelevant information about other residents, and contain notes written by someone other than Surveyor Flanery, i.e., Clavion Hall.  P. Objs. at 2.  Petitioner’s claims regarding hearsay evidence are again misplaced as explained above.  While I admit this document, I note that with respect to a reviewer’s opinion, the Board has stated that an “ALJ does not review CMS’s conclusions or determinations about earlier state agency-level review, but rather reviews de novo the entire record and determines whether the facility was or was not in substantial compliance with applicable regulations.”  See Kindred Transitional Care & Rehab - Greenfield, DAB No. 2792 (2017) (citing Britthaven of Chapel Hill, DAB No. 2284 at 4-6 (2009)).  Moreover, the presence of possibly irrelevant information in the exhibit and the presence of another surveyor’s notes in the exhibit do not warrant exclusion of the exhibit.  In order to view the statements and information in CMS Exhibit 7 in their full context, I find it necessary to admit CMS Exhibit 7 in its entirety into the record.  42 C.F.R. § 498.61.  Also, if Petitioner believed that Clavion Hall’s notes were deficient in any way, Petitioner could have requested a subpoena for Clavion Hall and could have cross-examined him.  However, Petitioner chose not to do so.  42 C.F.R. § 498.58.

Lastly, Petitioner objects to CMS Ex. 8, which is Surveyor William Flanery’s declaration, asserting that it contains inadmissible hearsay, i.e., multiple interviews with facility employees, and that he lacks clinical qualifications to opine on whether Petitioner provided the necessary care to Resident 1.  P. Objs. at 3.   As to Petitioner’s hearsay objection, Petitioner’s claims regarding hearsay evidence are misplaced once again as explained above.  Furthermore, “[t]he Board has also consistently held that statements of facility employees to the surveyor may be admitted in an administrative proceeding and may constitute substantial evidence for purposes of review.  The issue is whether there are indicia that the statements contained in the survey report are reliable.”  Beatrice State Developmental Ctr., DAB No. 2311 at 17-18 (2010) (citations omitted).  As to Petitioner’s second basis for objecting to CMS Ex. 8, contrary to Petitioner’s position, the survey at issue here, a complaint investigation, was not governed by the survey composition requirements at 42 U.S.C. § 1395i-3(g)(2).  Avon Nursing & Rehab. v. Becerra, 119 F.4th 286 (2d Cir. 2024); Avon Nursing Home, DAB No. 2830 (2017).  Besides this, I do not rely on the surveyor’s legal opinion or conclusions in evaluating whether Petitioner was in substantial compliance with Medicare participation requirements.  Avon, DAB No. 2830 at 11-12 (2017). 

Therefore, I overrule Petitioner’s objections and admit all of CMS’s proposed exhibits into the record.

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IV.  Issues

1) Whether Petitioner was in substantial compliance with the requirements of 42 C.F.R. § 483.25 (Tag F684) (scope and severity level “J”), relating to quality of care; and

2) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25, whether the $22,584 per-instance CMP for the instance on April 4, 2022, is appropriate and reasonable under applicable statutory and regulatory factors.

V.  Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at a SNF. 42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, a SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because a SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements related to how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.2

When a SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.  To maintain “substantial compliance,” a SNF’s

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deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

Broadly, noncompliance that subjects a SNF to enforcement remedies is divided into two levels.  One level comprises deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  “Immediate jeopardy” exists when “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.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that a SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  See 42 C.F.R. § 488.404(a)-(b).

One such remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after March 17, 2022, and for deficiencies that occurred after November 2, 2015, the per-instance CMP amounts may range from $2,400 to $23,989.  45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,111 (Mar. 17, 2022); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an ALJ to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance.  The level of noncompliance can only be challenged if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF or would affect a finding of substandard quality of care that results in the loss of approval for a SNF or NF of its NATCEP.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

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If an SNF challenges the finding of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  If a SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on a SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero or review CMS’s exercise of discretion in imposing a CMP.  42 C.F.R. § 488.438(e)(1)-(2).

Either the SNF or CMS may request Board review of an ALJ’s decision.  42 C.F.R. § 498.80.

VI.  Findings of Fact and Conclusions of Law3

1. Relevant Facts.

Resident 1, a male resident with highly pigmented skin4 , was 59 years old during the relevant time.  CMS Ex. 4 at 1.  He was admitted to Petitioner’s facility on February 18, 2022, with multiple diagnoses including:  end stage renal failure disease, type 2 diabetes, atherosclerotic heart disease, muscle wasting and atrophy, other abnormalities of gait and mobility, unsteadiness of feet, muscle weakness, and need for assistance with personal care.  CMS Ex. 4 at 1-2.

Resident 1’s February 25, 2022 Minimum Data Set (MDS) noted that Resident 1 needed assistance with the activities of daily living.  CMS Ex. 4 at 13.  He required a two-person assist and extensive assistance with bed mobility and with transfers.  CMS Ex. 4 at 13.  He also required a two-person assist and limited assistance for dressing and a one-person assist and limited assistance with personal hygiene.  CMS Ex. 4 at 13.  The Brief Interview for Mental Status (BIMS) in the MDS stated that Resident 1’s BIMS score was 15, which indicates Resident 1 was cognitively intact.  CMS Ex. 4 at 12.

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Resident 1’s admission evaluation noted that the skin on his feet was extremely dry and cracked.  CMS Ex. 4 at 25.  In response to this observation, Petitioner’s staff were required to apply a lotion to his feet every shift.  Id.  His care plan contained interventions to address the possible effects of his diabetes.  CMS Ex. 4 at 5.  The care plan required staff to inspect Resident 1’s feet daily for open areas, sores, pressure areas, blisters, edema, or redness.  Id.  It also required staff to check “all of body for breaks in skin and treat promptly as ordered by doctor.”  Id.  Regarding Resident 1’s need for dialysis, the care plan listed interventions which instructed staff to encourage Resident 1 to attend his dialysis appointment on Mondays, Wednesdays, and Fridays and instructed staff “to monitor for dry skin and apply lotion as needed.”  CMS Ex. 4 at 6.

According to weekly skin assessments for the weeks of February 25, 2022, March 4, 2022, March 11, 2022, March 18, 2022, March 25, 2022, and April 1, 2022, Petitioner’s staff completed skin assessments for those weeks using direct observation and communication with Resident 1, “as well as communication with licensed and non-licensed direct care staff members.”  CMS Ex. 4 at 27-33.  All of the abovementioned skin assessments recorded that Resident 1 did not have any skin impairments.  Id.  If staff would have recorded any skin impairment in the skin assessment, they would have been required to document the impairment and complete a weekly wound progress “UDA.”  Id.

On March 28, 2022, Keith Crandall, D.P.M., examined Resident 1’s feet.  CMS Ex. 4 at 38.  Dr. Crandall documented his findings on a March 28, 2022 Routine Foot Care form, which indicated that Dr. Crandall had observed “dry gangrene . . . to [Residents’1 right] first toe [with] no infection” observed.  CMS Ex. 4 at 38.  Dr. Crandall did not report his findings to Petitioner at the time of the visit.  See CMS Ex. 7 at 11.  Dry gangrene is defined as “a form of gangrene in which the involved part is dry, sharply demarcated, and shriveled; usually due to slowly occlusive vascular disease.”  Dry gangrene, Stedman’s Medical Dictionary (2014).  “It is not uncommon for dry gangrene to spread rapidly.”  CMS Ex. 7 at 11.

On April 1, 2022, a Friday when Resident 1 had his dialysis appointment, licensed vocational nurse (LVN) B conducted the weekly skin assessment on Resident 1 but failed to assess Resident 1’s feet.  CMS Ex. 7 at 13; CMS Ex. 4 at 32.  LVN B did not notice any skin impairments and conducted the assessment using direct observation and communication with Resident 1.  CMS Ex. 4 at 32.  According to LVN B, the restorative aide, who assisted Resident 1 in getting ready for dialysis, did not report a change in condition.  CMS Ex. 7 at 13.  Although LVN B stated that it is harder to assess a change in condition on “darker skin,” LVN B confirmed that she would be able to identify a change or impairment on highly pigmented skin.  CMS Ex. 7 at 13.  According to LVN B, Resident 1 did not like for the light to be on in his room and that he had dark skin, which made the assessment of a change in skin condition harder.  CMS Ex. 7 at 13.  Moreover, on the day of the assessment, Resident 1 apparently insisted on keeping his

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socks on.  CMS Ex. 7 at 15.  As a result, LVN B did not inspect his feet during the skin assessment.  CMS Ex. 7 at 13.  Resident 1 wore socks regularly and would change into a new pair every other day before he went to his dialysis appointment.  CMS Ex. 7 at 16.

Resident 1 complained about foot tenderness to certified nurse aide (CNA) A.  CMS Ex. 7 at 14-16.  CNA A informed LVN B of Petitioner’s foot tenderness. CMS Ex. 7 at 14.  During the morning shift on April 3, 2022, CNA B discovered and reported Resident 1’s condition to LVN D.  CMS Ex. 7 at 14-16.  Although LVN D had knowledge of this change in condition, LVN D took no immediate action and waited until the shift change to ask LVN C to assess Resident 1’s right foot.  CMS Ex. 7 at 15.  According to an April 4, 2022 skin/wound note, LVN C went to Resident 1’s room to assess his right foot.  CMS Ex. 4 at 7.  While conducting the assessment, LVN C observed that “[a]ll toes on [the] right foot [were] black with necrotic tissue[.]”  CMS Ex. 4 at 7.  LVN C also observed necrotic tissue on the “right lateral side of the foot and whole circumference of the bottom of [the] right heel . . . .”  CMS Ex. 4 at 7.  LVN C took pictures of Resident 1’s right foot and notified Resident 1’s physician, Dr. Carl Earnest, and Jerome Watson, NP of this change in condition and submitted the pictures she took to them.  CMS Ex. 4 at 3-4, 7.  Although Petitioner’s staff were aware of the change in skin condition and notified the necessary individuals of said change, Petitioner’s staff did not take additional steps on the evening of April 3, 2022 to address Resident 1’s change in condition.  See CMS Exs. 4, 7.

On April 3, 2022, Jerome Watson, NP informed Petitioner’s Assistant Director of Nursing (ADON) that he would assess Resident 1’s foot on April 4, 2022.  On April 4, 2022, NP Watson arrived at the facility to examine Resident 1’s right foot.  CMS Ex. 4 at 10.  NP Watson assessed Resident 1’s right foot and, upon examining the resident, observed discoloration to parts of the right foot.  CMS Ex. 4 at 10.  NP Watson “diagnosed the foot as being ‘Peripheral Arterial Disease’ which can have the circulation cut off to the lower extremities in a very quick time which is likely the cause of the dry gangrene.”  P. Ex. 2 at 3; P. Ex. 2 at 2 (“[Resident 1] had dry gangrene of the lower extremities. . . .  Dry gangrene is caused by poor blood flow to the involved tissues.  In [Resident 1’s] case, he had severe peripheral arterial disease, advanced diabetes, anemia, [and] CAD.”).  He ordered an immediate Doppler ultrasound.  CMS Ex. 7 at 11.  NP Watson told the surveyor that it was urgent for Resident 1 to receive a Doppler ultrasound and restore circulation to the leg to prevent amputation.  CMS Ex. 2 at 9.  However, after failed attempts to schedule the exam, NP Watson sent Resident 1 to the emergency room for evaluation on April 4, 2022. CMS Ex. 7 at 11.

Resident 1 was admitted to the hospital on April 4, 2022.  CMS Ex. 4 at 20.  Hospital records indicate that Resident 1 had “gangrene from the tips of digits 1 through 5 proximally to the metatarsal phalangeal joints and had an area of necrosis spanning along the lateral aspect of the foot in the heel.”  CMS Ex. 4 at 20.  The pre-operation diagnosis included gangrene to right foot and a right foot wound.  CMS Ex. 4 at 16.  After

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admission, physicians at the hospital decided that in order to salvage the limb, a right metatarsal amputation was necessary.  CMS Ex. 4 at 16, 23.

On April 19, 2022, state agency surveyors completed a survey in Petitioner’s facility.  CMS Ex. 2.  As part of the survey, the surveyors interviewed Petitioner’s former director of nursing (DON) and Resident 1.

The former DON informed a surveyor that Petitioner did not know about Resident 1’s dry gangrene until Petitioner’s staff received Dr. Crandall’s March 28, 2022 report on April 5, 2022.  CMS Ex. 7 at 12-13.  The DON explained that Dr. Crandall did not report the gangrene to the facility at the time because no interventions were needed.  Id.  Also, the DON reiterated the need to monitor Resident 1’s feet daily and that nurses and Petitioner’s staff were to report a change in condition of any resident.  Id.  The DON informed a surveyor that Petitioner’s practice is for staff members to perform skin assessments from head to toe.  Id.  The DON went so far as to say that LVN B should have “looked at all areas of Resident [1’s] body . . . .”  Id.  The DON told the surveyor that “if the Podiatrist had informed the facility about what he found, staff could have notified the doctor and maybe had a doppler ordered.”  Id.

As to Resident 1’s interview, the interview revealed that Resident 1 did not notice his right foot getting darker until after the Podiatrist evaluated his foot on March 28.  CMS Ex. 7 at 16.   He conveyed that he informed CNA B about his foot “turning black.”  CMS Ex. 7 at 16.  According to Resident 1, CNA B told him that she would tell a nurse of this change in condition.  She failed to do so.  CMS Ex. 7 at 16.  He had to “tell her a second time a couple of days later” about the change in condition for the CNA to eventually have a nurse evaluate his foot.  Id.  Resident 1 ended his interview by telling the surveyor that the change in condition “hurt him ‘really bad’” and that he was afraid that losing his foot would prevent or limit his ability to walk.  CMS Ex. 7 at 16.

2. Petitioner’s Wound Management Policy

The purpose of Petitioner’s Wound Management policy is to “provide a system for the treatment and management of residents with wounds . . . .”  CMS Ex. 6 at 1.  The policy states that a “resident who has a wound will receive the necessary treatment and services to promote healing, prevent infection and prevent new pressure injuries from developing.”  Id.  In order to achieve the policy’s expressed purpose, the policy required, among other things, that a licensed nurse perform a skin assessment upon admission, readmission, weekly and as needed for each resident and, upon identification of a new wound, that the nurse complete a wound monitoring record that would be included in the resident’s medical record.  CMS Ex. 6 at 2.  The licensed nurse was also required to document the effectiveness of current treatment in the resident’s medical record on a weekly basis, document notifications following a change in the resident’s skin condition, and update the resident’s care plan as necessary.  CMS Ex. 6 at 3.

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3. Texas Nursing Standards.

In relevant part, the Texas standards of practice provide that nurses must accurately and completely report and document the client’s status including signs and symptoms; nursing care rendered; physician, dentist, or podiatrist orders; administration of medication and orders; client response; and contacts with other team members concerning significant events regarding client’s status.  CMS Ex. 9 at 1.

4. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 (Tag F684) because Petitioner did not ensure that Resident 1 received treatment and care in accordance with Resident 1’s care plan, professional standards of practice, and Petitioner’s policy.

The Social Security Act requires SNFs to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.”  42 U.S.C. § 1395i-3(b)(2).  In furtherance of this mandate, the Secretary promulgated the general quality of care regulation at 42 C.F.R. § 483.25, which states that the SNF “must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.”5

“A SNF also would need to furnish the care and services in the resident’s care plan, implement doctors’ orders, monitor and document the resident’s condition, and follow the SNF’s resident care policies.” Lutheran Home, DAB No. 3146 at 4 (2024); Venetian Gardens, DAB No 2286 at 5 (2009) (“The Board has repeatedly stated that a facility's failure to follow its care plan or a doctor’s order may be grounds for concluding that the facility is not in substantial compliance with section 483.25 quality of care standards.”).  A facility’s policy “may reflect that facility’s own judgment about how best to achieve compliance and hence failure to comply with its own policies can support a finding” that the facility was not in substantial compliance with the regulations.  Bivins Mem’l Nursing Home, DAB No. 2771 at 9 (2017). 

However, “the statute and regulations hold facilities to meeting their commitments to provide care and services in accordance with the high standards to which they agreed but do not impose strict liability, i.e., they do not punish facilities for unavoidable negative outcomes or untoward events that could not reasonably have been foreseen and forestalled.”  Tri-County Extended Care Ctr., DAB No. 1936 (2004).

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CMS argues that Petitioner was not in substantial compliance with the quality of care requirements at 42 C.F.R. § 483.25 because Petitioner failed to provide the necessary care to Petitioner in accordance with Resident 1’s comprehensive assessment and failed to ensure the resident received treatment and care in accordance with professional standards of practice, the care plan, and the resident’s choices.  CMS Br. at 13.  Specifically, CMS contends that the facility failed to monitor, accurately document, and respond to the spread of gangrene in Resident 1’s right foot.  Id.

Petitioner disputes CMS’s allegations.  P. Br.  Petitioner argues that the evidence shows that Petitioner properly monitored Resident 1’s feet, documented the deterioration of Resident 1’s foot, and Petitioner’s staff notified and consulted Resident 1’s nurse practitioner and attending physician.  Id. at 7.  Petitioner alleges that Resident 1’s skin deterioration was unavoidable and that wound healing would be impossible.  Id.  Petitioner further states that “no action or inaction by Petitioner resulted in Resident [1] developing gangrene.”  P. Br. at 5.  It argues that Petitioner’s physicians knew about Resident 1’s dry gangrene diagnosis and that his diagnosis did not require any procedure or medication to address the dry gangrene.  Petitioner states that according to the physicians, there was nothing to be done to salvage the affected digits and that they would auto amputate.  P. Br. at 5.  Petitioner contends that Resident 1 never expressed any foot pain that would indicate a change in condition.  See P. Br. at 5.  In other words, Petitioner claims that it substantially complied with the requirements set forth in the quality-of-care regulation.

Contrary to what is alleged by Petitioner, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 because it failed to provide the required treatment and care to Resident 1 in accordance with Resident 1’s care plan, the professional standards of practice, and Petitioner’s wound management policy.  These failures clearly posed a potential for more than minimal harm.

Petitioner failed to ensure that Resident 1 received the care required by the care plan.  Given that Resident 1 was diabetic, Resident 1’s care plan required Petitioner’s staff members to inspect Resident 1’s feet daily for open areas, sores, pressure areas, blisters, edema, or redness.  CMS Ex. 4 at 5.  The care plan also required staff to “[c]heck all of [his] body for breaks and treat promptly as ordered by the doctor.”  CMS Ex. 4 at 5.  These assessments should have been performed from head to toe.  CMS Ex. 7 at 13.  Something Petitioner’s staff failed to do.  On April 1, 2022, a Friday where Resident 1 was scheduled to attend a dialysis appointment, Petitioner’s staff attempted to complete a full skin assessment on Resident 1.  CMS Ex. 7 at 13.  However, when conducting the skin assessment, LVN B did not assess the skin of Resident 1’s feet, although LVN B was required to do so.  Id.  Petitioner seems to argue that the failure to evaluate the condition of the feet’s skin was excused by Resident 1’s decision to keep his socks on.

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However, nowhere in the record is there documentation reflecting Resident 1’s decision to reject the care, i.e., the skin foot assessment, that needed to be provided on him.

While a documentation survey report for April 2022 shows that Petitioner’s staff conducted skin assessments on Petitioner on March 29, 30, and 31, 2022 and on April 2, 2022, the evidence in the record shows that Petitioner’s staff either failed to assess Resident 1’s feet or failed to properly assess his feet on those days.   Although the March 28, 2022 routine foot care form filled out by Dr. Crandall stated that Dr. Crandall noted dry gangrene to Resident 1’s right first toe, CMS Ex. 4 at 38, the weekly skin assessment forms for the weeks of March 25, 2022 and April 1, 2022 documented no change in condition or provided that Resident 1 did not have any skin impairments.  CMS Ex. 4 at 36.  Resident 1’s care plan or other documentation in the record does not contain information regarding the change in condition.  The record also contains multiple references to Petitioner’s staff’s arguments regarding their inability to properly assess Resident 1’s feet.  See CMS Ex. 4; CMS Ex. 7 at 11, 13, 19 (noting that the change in condition was not as noticeable because Resident 1 has highly pigmented skin, allegations that the darker the resident’s skin the harder it is to assess a change in condition, and Resident 1 liked to wear socks and “did not like the light on.”)  However, Petitioner’s staff’s arguments regarding the color of Resident 1’s skin and his alleged preference to keep his socks on do not lessen their responsibility to properly care for Resident 1.  Thus, the abovementioned evidence shows that Petitioner failed to ensure that Resident 1 received the care required by the care plan either because Petitioner failed to provide the necessary care or failed to provide adequate care that would have led to the prompt discovery of the change in condition.

Even if I were to find that Petitioner ensured that care was provided to Resident 1 in accordance with the care plan and its policy of conducting skin assessments from head to toe, which I do not find, Petitioner failed to ensure that Resident 1 received care in accordance with professional standards of practice.  Petitioner argues that the change in condition was sudden because Petitioner’s staff performed the required skin assessment as directed; adequately monitored Resident 1’s right foot when staff members provided all the necessary care, including when bathing him on the days after Dr. Crandall noted the presence of gangrene; and suggests that there was nothing to document since Resident 1’s change in condition only occurred suddenly on April 3, 2022.  P. Br. at 6-8.  Otherwise, since Petitioner provided the required care, Petitioner’s staff would have observed the change in condition.  See P. Br.

Petitioner’s assertion and suggestions are belied by the record.  Petitioner’s Wound Management Policy and the professional standards of practice established by Texas regulations require nurses to document changes in condition and accurately and completely report and document a resident’s status, including signs and symptoms.  CMS Ex. 6, 9.  Petitioner’s staff failed to comply with this requirement when they improperly documented in the weekly skin assessments for the weeks of March 25, 2022 and April 1,

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2022 that Resident 1 did not have any skin impairments.  CMS Ex. 4 at 32.  Although Dr. Crandall noted on March 28, 2022 the presence of dry gangrene on Resident 1’s right toe, Petitioner’s skin assessment reports contain no mention of this change in condition.  There is no document in the record that recorded the change in condition after Dr. Crandall’s visit.  The form Dr. Crandall prepared where he noted the presence of dry gangrene was given to the facility on April 5, 2022, and Dr. Crandall did not report the change in condition to the facility.  CMS Ex. 4 at 38; CMS Ex. 7 at 12-13.

The record also shows that the change in condition was not sudden.  On March 28, 2022, the gangrene was localized on Resident 1’s right toe.  CMS Ex. 4 at 38.  By April 4, 2022, gangrene developed on all of Resident 1’s right toes and a section of his right foot. CMS Ex. 4 at 14-22.  Assuming Petitioner provided the care in accordance with the care plan, Petitioner’s staff would have discovered the gangrene on Resident 1’s right foot and should have documented the change in condition, which they failed to do.  This also supports my finding that Petitioner did not ensure that care was provided to Resident 1 in accordance with his care plan because if care would have been provided as alleged, Petitioner would have discovered the change in condition before April 3, 2022 and at least on or after March 28, 2022 and staff would have documented such a finding.

All of these failures at least posed a potential for more than minimal harm because it prevents prompt identification of a change in condition and prevents implementation of an adequate and prompt response to that change in condition.  The result in this case does not change because Petitioner’s actions did not cause the gangrene on Resident 1’s right foot.  See P. Br. at 5.  Causation is not a requirement for a finding of substantial noncompliance in this case.  The potential for more than minimal harm posed by Petitioner’s noncompliance emanates from the previously mentioned failures to provide the necessary care in accordance with the care plan and professional standards of practice.  Petitioner suggests that the noncompliance did not pose a potential for minimal harm because Resident 1’s doctors claimed that once gangrene was observed on the right toe, nothing needed to be done because the best treatment for dry gangrene was to let the “body auto-amputate the dead and necrotic tissue itself naturally.”  P. Br; P. Ex. 2.  However, as the record shows, the gangrene eventually spread and developed on all of Resident 1’s right toes and a section of the foot.  If Petitioner had provided care in accordance with the care plan and professional standards of practice, Petitioner could have identified the change in condition, observed that the gangrene did not remain localized, and could have responded to those changes to address the gangrene.  For example, if identified after March 28 and before April 3, 2022, staff would have noted the change in condition and the spread of the gangrene.  It would have allowed staff to schedule an “arterial Doppler” to determine whether the Doppler reveals significant arterial disease and would allow physicians to refer Resident 1 for necessary treatment to address the change in condition.

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I conclude that CMS provided sufficient evidence to meet its burden of showing a prima facie case for a deficiency (i.e., the potential for causing more than minimal harm).  Hillman, DAB No. 1611 at 8.  Moreover, Petitioner’s assertions are unpersuasive.  The evidence shows that Petitioner failed to provide the required care to Resident 1 and that failure at leased posed a risk for more than minimal harm.  I conclude that Petitioner did not comply substantially with 42 C.F.R. § 483.25.

VII.  The level of noncompliance is unreviewable in this case

CMS determined Petitioner’s noncompliance with 42 C.F.R. § 483.25 constituted immediate jeopardy.  Petitioner’s arguments may be construed as a challenge to the level of noncompliance based on Petitioner’s claim that Resident 1’s change in condition was caused by his medical condition, not by Petitioner’s actions or omissions.  See P. Br.  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13).  However, a facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or would impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  If reviewable, 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); Woodstock Care Ctr., DAB No. 1726 at 9 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).

Neither of the circumstances that permit Petitioner to challenge the level of noncompliance exists in this case.

A successful challenge would not affect the range of the CMP that CMS may impose.  The scope and severity determination does not affect the CMP range CMS may choose when imposing a per-instance penalty.  In the case of a per-instance CMP, the regulations provide for a single penalty range without regard to the level of noncompliance.  42 C.F.R. § 488.438(a)(2).  Thus, if CMS decides to impose a per-instance CMP, the amount selected must fall within the single range.  There is no separate, lower range CMS could choose.  “The Board has long held that because a per-instance CMP has a single range, a successful challenge to a per-instance CMP could not affect the range of the CMP.”  Pearsall Nursing & Rehab. Ctr. – N., DAB No. 2692 at 10 (2016).

Petitioner does not argue that the second basis that authorizes review is present in this case.  Petitioner does not allege that it had a NATCEP when CMS issued its notice of noncompliance nor that it lost such a program because of a substandard quality of care finding.  Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2378 at 24 (2011).  There is neither evidence of a finding of substandard quality of care that resulted in the loss of approval of Petitioner’s NATCEP nor evidence that Petitioner had such a program when CMS issued its notice of noncompliance.  Oaks of Mid City Nursing & Rehab. Ctr., DAB

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No. 2378 at 24; see CMS Ex. 1.  Furthermore, “the loss of approval for a NATCEP program would not be affected by a successful challenge to the level of noncompliance because, by operation of law, the imposition of a CMP of $5,000 or more results in NATCEP loss whether or not immediate jeopardy is present.”  Fort Madison Health Ctr., DAB No. 2403 at 13 (2011) (citing Act 1819(f)(2)(B)(iii)(I)).  CMS’s level-of-noncompliance finding does not affect approval of the facility’s NATCEP when I uphold a penalty of $22,584 or more.  Under the statute and regulations, the state agency cannot approve a NATCEP if CMS imposes a penalty of $11,995 or more.  42 C.F.R. § 483.151(b)(2)(iv); 45 C.F.R. § 102.3 (2022).  Thus, the facility loses its approval without regard to the level noncompliance finding.

VIII.  The $22,584 per-instance CMP imposed by CMS is reasonable.

CMS imposed a per-instance CMP in the amount of $22,584 on Petitioner.  CMS Ex. 1.  The CMP was imposed for the instance on April 4, 2022.  Id.  When determining whether the CMP amount is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance, including repeated deficiencies; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2), (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  The Board has explained that “there is a presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS.  Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.” Coquina Ctr., DAB No. 1860 at 32 (2002).  The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017).

Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404.  See, e.g., Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010).  The per-instance CMP range of $2,400 to $23,989,

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as adjusted for inflation, is applicable to this case.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,111.

Petitioner did not provide any arguments to demonstrate that a reduction is necessary to make the CMP amount reasonable.  Therefore, I uphold the $22,584 per-instance for the instance on April 4, 2022.  Petitioner’s brief only argues that the CMP should not be imposed because the facility was in compliance with the conditions of participation and that CMS did not offer any evidence to support the assertion that the CMPs are reasonable.  Petitioner argues that the total amount of the CMP is unreasonable because CMS failed to establish its prima facie case, and even if it established its prima facie case, Petitioner successfully rebutted CMS’s prima facie case by a preponderance of the evidence.  P. Br. at 8.  However, as stated above, I have determined that the facts before me support a finding of substantial noncompliance.  Thus, the issue before me is whether the regulatory factors were considered in setting the CMP amount and whether those factors support the CMP amount.  42 C.F.R. §§ 488.438(f), 488.404.  Petitioner does not allege that a particular regulatory factor does not support the CMP amount.  See P. Br.  Nonetheless, I will briefly discuss the relevant factors.

Scope and Severity of Deficiencies and Relationship Between Deficiencies:  Considering the factors, Petitioner’s noncompliance was very serious.  Petitioner’s failure to ensure that Resident 1 received care in accordance with its care plan and professional standards of practice prevented the staff and physician from acting promptly to prevent the partial loss of the right foot or to prevent further spread of the gangrene.

Culpability:  Petitioner’s culpability is also significant as Petitioner’s failures show a disregard for Resident 1’s care and safety.

Facility’s History of Non-Compliance:  CMS has presented evidence of Petitioner’s noncompliance history and remarks that Petitioner’s history “involve numerous deficiencies, some cited repeatedly, including immediate jeopardy-level deficiencies . . . .”  CMS Br. at 16 (citing CMS Ex. 10).  Petitioner has not offered any argument or rebuttal to CMS’s evidence showing its history of noncompliance.  CMS Ex. 10.

Financial Condition of the Facility:  “In weighing evidence on financial condition, the Board has consistently held that the ‘correct inquiry is ‘whether the facility has adequate assets to pay the CMP without having to go out of business or compromise resident health and safety.’”.  Van Duyn Home & Hosp., DAB No. 2368 at 18 (2011) (quoting Gilman Care Ctr., DAB No. 2362, at 6 (2010)).  “It is the responsibility of the facility to furnish the information it believes appropriately represents its financial status.”  Gilman, DAB No 2362 at 7.  Petitioner presents no evidence of its financial condition.  Therefore, this is not a factor that impacts the CMP amount in this case.

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CMP Amount:  Although the amount is at the higher end of the penalty range, I find no basis to reduce the CMP.  Therefore, based on the factors above and in consideration of the amount imposed, the CMP imposed is supported by the record and is appropriate.

IX.  Conclusion

For the reasons set forth above, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 and that the $22,584 per-instance CMP for the instance on April 4, 2022 is fully supported by the relevant statutory and regulatory factors in this case.