Stonebridge at Montgomery Health Care Center, DAB CR6849 (2026)

DECISION

Stonebridge at Montgomery Health Care Center (Petitioner or facility) is a skilled nursing facility (SNF) that participates in the Medicare program.  The New Jersey State Department of Health and Senior Services (state agency) conducted a survey of the facility and concluded that Petitioner was noncompliant with Medicare program participation requirements concerning two residents.

An occupational therapist (OT) at Petitioner’s facility assessed Resident 14 (R14) and determined that facility staff needed to use a Hoyer lift to transfer R14 between surfaces because R14 could not safely transfer using a sit-to-stand device.  Later, facility staff used a sit-to-stand device to transfer R14.  A facility inquiry concluded that the use of the sit-to-stand device likely caused R14 to be bruised in the left axilla and breast area.  A physical therapist (PT) assessed R14 as requiring a Hoyer lift, and facility staff were trained not to use the sit-to-stand device when transferring R14.  R14 was later assessed as requiring a two-person assist when transferring, and Petitioner formally added to R14’s care plan that R14 was only to be transferred by Hoyer lift with a two-person assist.  Shortly after this, a single facility staff member transferred R14 from a shower seat to her wheelchair using a sit-to-stand device.  Within two days, R14 had a bruise in her left axilla and breast area.  Sent to a hospital, R14 was diagnosed with a hematoma,

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likely caused by trauma.  A facility inquiry concluded that the bruise was probably caused by the transfer using the sit-to-stand device. 

In another incident, a facility nurse cleaned a wound for Resident 2 (R2) while wearing gloves that had been contaminated by touching R2’s bed controller and a bag that had fallen on the floor.  Further, after the nurse removed her gloves and cleaned her hands, she applied bacitracin to R2’s skin tear without putting new gloves on her hands. 

Based on the results of the state agency survey, the Centers for Medicare & Medicaid Services (CMS) imposed a civil monetary penalty (CMP) on Petitioner for failing to ensure that R14 received adequate supervision and assistance devices to prevent accidents, and another CMP on Petitioner for failing to maintain its infection control program (ICP) in relation to R2’s wound care.  Petitioner requested a hearing to dispute CMS’s determination. 

As explained below, I conclude that Petitioner was noncompliant with 42 C.F.R. § 483.25(d) because Petitioner’s staff failed to implement R14’s care plan, which required two staff members to transfer R14 using a Hoyer lift.  Petitioner argues it was in compliance with the regulations because CMS cannot prove that use of the sit-to-stand device caused R14’s bruising to her left axilla and breast area.  I reject this argument because such bruising occurred after each use of the sit-to-stand device and Petitioner’s own inquiries concluded that the sit-to-stand device likely caused the bruising.  Regardless, Petitioner’s failure to ensure that two staff members transferred R14 with a Hoyer lift is sufficient to show that Petitioner failed to be in substantial compliance with 42 C.F.R. § 483.25(d). 

In addition, I conclude that Petitioner was noncompliant with 42 C.F.R. § 483.80(a).  Although Petitioner argues that the nurse’s actions met acceptable standards for infection control, there is no doubt that the nurse contaminated the gauze that were being applied to the resident’s wounds.  Further, the nurse failed to wear gloves when applying medication to R2’s wound. 

Finally, Petitioner did not challenge any of the regulatory factors used to determine the amounts of the CMPs in this case.  As a result, I uphold them.  Therefore, I affirm CMS’s initial determination. 

I.  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 the age of 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i). 

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For Medicare program purposes, an 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).  If an SNF wants to participate in the Medicare program, it must enroll in that program.  42 U.S.C. § 1395cc(j).  Because an SNF is a “provider of services” for Medicare program purposes, each SNF participating 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). 

A Medicare participating SNF must meet a variety of ongoing statutory requirements as to how it provides services, maintains the rights of its residents, and administers its facility.1   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 implement the statutory requirements and to establish those “other requirements relating to health, safety, and well-being of residents.”  See 42 C.F.R. pt. 483, subpt. B.2 

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When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see also 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; see also 42 U.S.C. § 1395i-3(h)(3).  To maintain “substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  

“It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to survey participating SNFs.  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 investigate complaints made against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4). 

When the results of a survey or investigation show that an SNF is not in substantial compliance with Medicare program participation requirements, the Secretary may impose remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  All remedies imposed on SNFs are remedial in nature because they “ensure prompt compliance with [Medicare] program requirements” and “are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.”3   42 C.F.R. § 488.402(a)-(b); NMS Healthcare of Hagerstown, DAB No. 2603 at 8 n.6 (2014) (holding that, although the regulations use the term “civil money penalty,” the regulations also “make it clear that a CMP is not a punitive mechanism.”).  To assist a facility in returning to substantial compliance quickly, SNFs must file a plan of correction with the state agency/CMS.  42 C.F.R. § 488.402(d). 

When CMS selects a 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).  The highest level of severity occurs when the noncompliance immediately jeopardizes the health or safety of SNF residents.  See 42 U.S.C. § 1395i-3(h)(1)(A).  “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has

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caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301. 

One enforcement remedy is a denial of payment for new admissions (DPNA).  CMS must impose a DPNA if an SNF fails to be in substantial compliance with Medicare requirements for three months.  42 U.S.C. § 1395i-3(h)(2)(D); 42 C.F.R. § 488.417(b).  CMS may also impose a DPNA whenever an SNF is noncompliant with Medicare requirements.  42 C.F.R. § 488.417(a).  If the SNF does not have repeated instances of substandard quality of care, CMS payments resume prospectively on the date that the facility achieves substantial compliance with Medicare requirements either based on a revisit survey or credible written evidence that is acceptable to CMS.  42 C.F.R. § 488.417(d). 

Another enforcement 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 or a per‑day CMP for the number of days an SNF is not in substantial compliance.  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 January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts range as follows:  $2,233 to $22,320 for per-instance CMPs; $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see also 42 C.F.R. § 488.438(a) (CMP ranges before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of a remedy and/or the level of noncompliance if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF or a finding of substandard quality of care results in the loss of approval of a nurse aide training program.  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). 

If an SNF challenges the existence 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),aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Hum. Servs., No. Civ.A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); 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 an SNF challenges CMS’s

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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 an 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 the 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. 42 C.F.R. § 488.438(e)(1). 

Either the SNF or CMS may request that the Departmental Appeals Board (DAB) review an ALJ’s decision.  42 C.F.R. § 498.80; see also 5 U.S.C. § 557. 

II.  Background and Procedural History

Petitioner is an SNF located in Skillman, New Jersey.  On September 9, 2021, the state agency completed a recertification survey of Petitioner’s facility.  CMS Ex. 1 at 1.  Based on the survey, the state agency documented the deficiencies it found in a Statement of Deficiencies (SOD).  Among others, these deficiencies included: 

• 42 C.F.R. § 483.25(d)(1), (2) (F-Tag 689) (scope and severity (S/S) = G) (Free of Accident Hazards/Supervision/Devices).
• 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (F-Tag 880) (S/S = D) (Infection Prevention & Control). 

CMS Ex. 1 at 12-25, 31-36. 

On October 28, 2021, CMS issued a notice of initial determination based on the September 9, 2021 survey results.  CMS imposed a per-instance CMP for each of the deficiencies specified above: 

• $11,300 CMP for the deficiency related to 42 C.F.R. § 483.25(d)(1), (2).
• $5,000 CMP for the deficiency related to 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f). 

CMS Ex. 2 at 1-2. 

On December 22, 2021, Petitioner requested a hearing to dispute the findings of noncompliance as well as the reasonableness of the CMP amounts.  On December 28, 2021, the Civil Remedies Division acknowledged the hearing request and issued my Standing Prehearing Order (SPO), which provided dates for the parties to file prehearing submissions.

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On March 28, 2022, CMS filed a prehearing brief/motion for summary judgment and 20 proposed exhibits (CMS Exs. 1-20).  Two of the proposed exhibits (CMS Exs. 15, 17) were written direct testimony from witnesses.  On April 6, 2022, CMS filed an amended version of CMS Exhibit 15 to add the date for the signature on that written direct testimony. 

On May 25, 2022, Petitioner submitted a prehearing brief/opposition to summary judgment and 11 proposed exhibits (P. Exs. 1-11).  Four of the proposed exhibits (P. Exs. 5-8) were written direct testimony from witnesses. 

Petitioner requested to cross-examine CMS’s witnesses.  CMS did not request to cross-examine Petitioner’s witnesses. 

On December 6, 2022, I denied CMS’s motion for summary judgment and issued a Notice of Hearing in which I scheduled a video teleconference hearing for March 22, 2023.  Because neither party objected to any of the proposed exhibits, I admitted all of the exhibits into the record.  I only provisionally admitted the written direct testimony for CMS’s witnesses (CMS Exs. 15, 17) pending their cross-examination at the hearing. 

On March 22, 2023, I held a hearing at which Petitioner cross-examined CMS’s witnesses.  At the hearing, I fully admitted CMS Exhibits 15 and 17 into the record.  Hearing Transcript (Tr.) 158.  I also gave both parties an opportunity to file post-hearing briefs and required the parties to provide, in those briefs, all arguments and issues that they wanted me to consider when rendering this decision.  Tr. 156; May 12, 2023 Notice of Receipt of Transcript and Order Directing Post-Hearing Briefing Schedule at 1.  Both parties timely filed post-hearing briefs (CMS Br. and P. Br., respectively).  On October 12, 2023, CMS waived its right to file a reply brief. 

III.  Issues

1) Whether Petitioner was in substantial compliance with the Medicare program requirements for SNFs at 42 C.F.R. §§  483.25(d)(1), (2) and/or 483.80(a)(1), (2), (4), (e), (f). 

2) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2), whether a $11,300 per-instance CMP is appropriate under the statutory and regulatory factors for setting a penalty amount.  

3) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f), whether a $5,000 per-instance CMP is appropriate under the statutory and regulatory factors for setting a penalty amount.  

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IV.  Findings of Fact and Conclusions of Law

My findings of fact and conclusions of law are in bold and italics. 

42 C.F.R. § 483.25(d) Deficiency

1.  R14 was a 92-year-old resident who was cognitively and physically impaired.  R14’s care plan required the use of a Hoyer lift, with a two-person assist, to transfer R14 between surfaces.  On June 23, 2021, a single facility staff member used a sit-to-stand device to move R14 into her wheelchair from a shower chair.  R14 developed bruising in her left axilla and breast area.  The facility’s report on this incident concluded that R14 probably sustained the bruising when an aide, without assistance, used a sit-to-stand device to transfer R14. 

During the relevant events in this case, R14 was a 92-year-old female who had been admitted to the facility in 2016.  CMS Ex. 6 at 1, 4.  R14’s admitting diagnosis was Alzheimer’s Disease; however, other diagnoses included:  weakness; muscle weakness (generalized); need for assistance with personal care; dysphagia; and hypertension.  CMS Ex. 1 at 1. 

On November 20, 2020, an OT at the facility conducted an evaluation of R14 “to determine optimal mode of transfer and decreasing caregiver burden.”  CMS Ex. 7 at 2.  The OT’s initial conclusions were that R14 “poses difficulty in initiating sit to stand and demonstrates resistance during transfers.  She will benefit from sit to stand mechanical lift.”  CMS Ex. 7 at 2.  However, by November 25, 2020, the OT documented that R14 “demonstrates non compliance for therapy sessions or for sit to stand lift and difficulty for transfers.”  CMS Ex. 7 at 1.  The OT concluded:  “Hoyer lift recommended as a safe and optimal mode of transfer.”  CMS Ex. 7 at 1; CMS Ex. 15 ¶¶ 16-17; see also Tr. 49.  Following the final OT session on December 7, 2020, the OT reported that R14 was “non compliant for sit to stand lift”; therefore, Petitioner did not meet her short-term goal of performing transfers with a two-person assist and a sit-to-stand lift.  CMS Ex. 7 at 3.  The OT further concluded that Petitioner was “able to do transfers with assist of 1 to 2” with a Hoyer lift.  CMS Ex. 7 at 3. 

On March 16, 2021, a facility staff member reported that R14 had a bruise on the left side of her chest.  CMS Ex. 3 at 14.  Facility staff described the wound as “Reddish purple bruise to Left lateral breast and axilla.”  CMS Ex. 3 at 14-15.  

On March 17, 2021, Petitioner’s nursing staff completed a Nursing to Therapy Referral asking whether the nursing staff should use a Hoyer lift with two staff persons when transferring R14.  CMS Ex. 3 at 20.  On that same date, a PT responded in the affirmative

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and recommended “use of [H]oyer lift for promoting skin integrity.”  CMS Ex. 3 at 20; see also CMS Ex. 15 ¶¶ 17-18; Tr. 49. 

On March 17, 2021, Petitioner conducted an in-service training for staff on R14’s bruise on the left breast and axilla.  Staff was told that the probable cause for R14’s injury was “during transfer,” and “Resident will transfer only with [H]oyer lift.”  CMS Ex. 3 at 18; see also Tr. 49. 

A March 22, 2021 follow-up report on R14’s injury concluded that: 

Through investigation it was identified [that] some staff were using the sit to stand in which the straps fit[] underneath the arms and stand and pivot transfer technique in which two people interlock their arm[s] underneath bilateral armpit and Hoyerlift device in which resident is positioned on a sling device and mechanical[ly] lifted and applying no contact to armpit.  Resident assessed by PT and identified to be a Hoyerlift only for safety.  All staff in-serviced on the preferred technique for transfer. 

CMS Ex. 3 at 17. 

A May 4, 2021 Minimum Data Set (MDS) assessment included the following observations:  R14 had a Brief Interview for Mental Status (BIMS) score of 00, which is severe cognitive impairment (CMS Ex. 6 at 8; Tr. at 26); R14 needed “extensive assistance” and “two+ persons [to] physical[ly] assist” her for bed mobility, transfers between surfaces, dressing, and toileting (CMS Ex. 6 at 13); R14 was “[n]ot steady, only able to stabilize with staff assistance” when moving from a seated to standing position and during surface-to-surface transfers (CMS Ex. 6 at 14); and R14 needed a wheelchair for mobility (CMS Ex. 6 at 14).4 

Petitioner’s care plan for R14 identified as one of her “Problems” that R14 needed help with activities of daily living (ADL) due to cognitive deficits (i.e., Alzheimer’s).  CMS Ex. 4 at 8.  A May 13, 2021 intervention in the care plan stated:  “Two person assistance with transfers via HOYER lift.”  CMS Ex. 4 at 8; CMS Ex. 15 ¶ 7.  The requirement for a two-person assist is consistent with Petitioner’s general policy on mechanical lifts for transfers, which states that “[a]t least two people are required to transfer an elder using a mechanical lift.”  CMS Ex. 12 at 1.  

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On June 23, 2021, facility staff member A.B. used a “sit to stand” device to attempt to put R14 in her wheelchair from a shower chair.  CMS Ex. 3 at 8.  A.B. did this alone and without the assistance of another staff member because no other staff member was available.  CMS Ex. 15 ¶¶ 12, 20. 

On June 25, 2021, facility staff noted a “Skin issue” for R14.  CMS Ex. 3 at 4, 13.  A nurse documented the following: 

Upon entering resident[’]s room, resident has bruise to left axillary, left breast swollen with discoloration, lump on top of left breast, tender to touch and warm.  Resident screams while[] assessing lump on breast.  No pain with movement to the left arm except with touch.  Resident alert, disoriented, not able to explain how the bruise occurred.  [Physician] was called and informed, ordered to transfer resident to the hospital for further evaluation. 

CMS Ex. 3 at 4; see CMS Ex. 4 at 12. 

Petitioner transferred R14 to a hospital as ordered by R14’s physician.  CMS Ex. 19 at 3; CMS Ex. 15 ¶¶ 25-26.  A June 25, 2021 physician history and physical for R14 indicates she was sent to the hospital because Petitioner’s staff found a mass in her left upper chest.  CMS Ex. 19 at 4.  The physician noted that the hospital’s Emergency Department reported that R14 had pain; however, R14 did not have pain during the physician’s physical examination.  CMS Ex. 19 at 4.  Although not tender, the physician found an anterior chest mass extending to the axilla.  CMS Ex. 19 at 6.  An ultrasound showed a large hypoechoic lesion.  CMS Ex. 19 at 7.  The physician indicated R14 would be under observation.  CMS Ex. 19 at 8.  On June 28, 2021, following an ultrasound and CT scan, a physician assessed R14’s mass as “likely consistent with a hematoma. . . .  Likely traumatic.”  CMS Ex. 19 at 10, 39 (CT scan report that “[t]here is a large left-sided chest wall hematoma involving the subpectoral and caudal level of the wall.”). 

Petitioner readmitted R14 to the facility on July 1, 2021.  CMS Ex. 19 at 1. 

In a July 13, 2021 Corrective Action Plan for facility staff member A.B., a facility manager stated the following as the basis for the action: 

On approx. 6/23/2021, [A.B.] performed a transfer on [R14].  This resident has varying level of capability during transfer. . . .  In this instance, the resident should have been transferred using a two-person assist.  [A.B.] transferred the resident alone.  This could have led to serious injury or harm.  [A.B.] educated on the importance of following a care plan

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and using proper transfer equipment.  This type of action is unacceptable and will not be tolerated. 

CMS Ex. 3 at 9. 

In a “Follow up Report” written on July 21, 2021, a facility nurse, Modupe Victoria Ajala, R.N., concluded the following concerning the origin of R14’s injury: 

Resident sustained a bruise on the left under the shoulder area from the skin pad area, when the aide transfer[ed] without another[’s] assistance using the seat to stand lift.  The aide was educated on proper usage of devices. 

CMS Ex. 3 at 7; see also CMS Ex. 15 ¶ 20. 

2.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because it did not take all reasonable steps to provide adequate supervision and assistance devices necessary for R14 to transfer without accident or injury.  A single facility staff member attempted to transfer R14 from a shower chair to her wheelchair using a sit-to-stand device when R14’s care plan required that two staff members transfer her with a Hoyer lift.  R14 suffered injury, was sent to a hospital, and was admitted to the hospital for several days. 

The Social Security Act requires SNFs to “care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident” and “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)(1)(A), (2).  The services provided to residents “must meet professional standards of quality.”  42 U.S.C. § 1395i-3(b)(4). 

In furtherance of these stated requirements, the Secretary promulgated the “quality of care” requirements at 42 C.F.R. § 483.25.  One requirement imposes specific obligations on a facility related to resident supervision and accident prevention as follows:5 

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The facility must ensure that ˗

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents. 

Section 483.25(d)(1) requires a facility to address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  Maine Veterans’ Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)).  The provisions of section 483.25(d) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.”  Meridian Nursing Ctr., DAB No. 2265 at 9 (2009), aff’d sub. nom. Fal‑Meridian, Inc. v. U.S. Dep’t of Health & Hum. Servs., 604 F.3d 445 (7th Cir. 2010).  Further, section 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)).  Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision” for a particular resident’s needs.  Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub. nom. Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005). 

As explained above, the record contains clear documentation that, by June 23, 2021, none of Petitioner’s staff should have transferred R14 alone and/or with a sit-to-stand device.  Assessments from an OT (November 2020) and a PT (March 2021) both indicated that a Hoyer lift was required for safe transfers.  An MDS assessment in May 2021 indicated that R14 needed the assistance of two staff members when transferring. 

These assessments were supported by the March 2021 incident where R14 suffered bruising on her left breast and axilla after being transferred with the sit-to-stand device.  A facility inquiry concluded that the use of that transfer device probably caused the bruising.  CMS Ex. 3 at 18.  This resulted in the facility providing in-service training to staff that R14 was only to be transferred by Hoyer lift.  CMS Ex. 3 at 18.  Later, in May 2021, Petitioner formally added the requirement to R14’s care plan that R14 was only to be transferred by Hoyer lift with two staff members assisting.  CMS Ex. 4 at 8. 

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Despite Petitioner’s recognition that R14 could not safely be transferred using the sit-to- stand device and that two staff members were needed for a safe transfer, on June 23, 2021, a single staff member transferred R14 from a shower chair to a wheelchair using the sit-to-stand device.  CMS Ex. 3 at 8.  The staff member did this transfer alone because no other staff members were available to help.  CMS Ex. 15 ¶¶ 12, 20.  There is no indication that R14 objected to the use of the Hoyer lift.  See CMS Ex. 3 at 8.  Within two days, R14 manifested bruising on her left axilla and breast area, the same locations where R14 had bruising when she last was transferred with a sit-to-stand device in March 2021.  CMS Ex. 3 at 4.  Given the March 2021 injury, it was foreseeable that R14 would be bruised again if the sit-to-stand device was used. 

The facility inquiry into the June 2021 incident concluded that R14’s bruising was the result of the improper use of the sit-to-stand device instead of the Hoyer lift.  CMS Ex. 3 at 7.  At the same time, the facility formally took corrective action against the staff member, reminding her that a two-person assist was needed for R14’s transfers.  CMS Ex. 3 at 9. 

The introductory text to 42 C.F.R. § 483.25 (which is directly based on 42 U.S.C. § 1395i-3(b)(2)) makes clear that an SNF must ensure that each resident receives treatment and care in accordance with “the comprehensive person-centered care plan.”  Buena Vista Care Ctr., DAB No. 2498 at 16 (2013) (noting that the introductory text to 42 C.F.R. § 483.25 is incorporated into the accident and supervision provision, which is now located in 42 C.F.R. § 483.25(d)).  At the time of the June 23, 2021 transfer, Petitioner’s care plan for R14 required transfers to be accomplished through use of a Hoyer lift and a two-person assist.  Petitioner’s staff failed to follow the care plan, which was based on careful assessments as well as a previous injury to R14.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because Petitioner’s staff failed to provide adequate supervision and assistance devices for R14’s transfer.  Buena Vista Care Ctr., DAB No. 2498 at 14 (“Buena Vista’s undisputed failure to equip Resident 3’s wheelchair with the anti-tip device expressly required by his care plan was a clear violation of section 483.25[(d)].”). 

Petitioner does not agree that it failed to substantially comply with 42 C.F.R. § 483.25(d).  Petitioner asserts that it provided sufficient evidence to prove why R14 had bruising and a lesion, “and the fact that this likely had nothing to do with a wrongful assumption of trauma or failure to follow physician’s orders for transfers.”  P. Br. at 27; see also P. Br. at 17-18. 

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In support of Petitioner’s position, Petitioner’s expert witness, Gail Rader, R.N.,6  and Petitioner’s Medical Director, Jospeh Pecora, D.O.,7  both testified as to the lack of definitive proof that R14’s bruising in June 2021 was caused by the transfer using the sit-to-stand device.  Nurse Rader testified that the bruise found on R14’s left chest wall did not occur due to an improper transfer and that there is no way to conclude what caused the bruising because different transfer methods were being used for R14 at the time and any of them could have caused the bruise.  P. Ex. 5 ¶¶ 40, 42 (testifying that the cause of the June 2021 bruise “is not definitive.”).  Dr. Pecora testified that there is no evidence that R14 suffered any injury while a resident at the facility and that the bruise found on June 25, 2021 “may have been caused by that transfer but this is not definitive.”  P. Ex. 8 ¶¶ 30, 35, 44.  Both Nurse Rader and Dr. Pecora testified that R14 was on long term aspirin therapy, and this made R14 more susceptible to bruise without trauma.  P. Ex. 5 ¶ 40; P. Ex. 8 ¶ 33. 

As an initial matter, none of Petitioner’s arguments or witnesses refute the facts in the record, i.e., based on OT, PT, and MDS assessments, Petitioner added to R14’s care plan in May 2021 that transfers involving R14 had to be made with a Hoyer lift and two staff members, and on June 23, 2021, a single staff member transferred R14 from a shower chair to a wheelchair using a sit-to-stand device.  Even if R14 suffered bruising for an unrelated reason, that fact would not mean Petitioner had been in substantial compliance with 42 C.F.R. § 483.25(d).  See W. Texas LTC Partners, Inc., v. Dep’t of Health & Hum. Srvs., 843 F.3d 1043, 1047 (5th Cir. 2016) (“Again, the facts regarding the Hoyer straps [dangling dangerously] on Resident # 1 and Resident # 4’s wheelchairs are undisputed.  [The SNF] contends that Resident # 4 never fell out of the wheelchair, but that is irrelevant to whether the facility was in substantial compliance with a regulation regarding accident-prevention.”).  Transferring R14 using the Hoyer lift rather than the sit-to-stand device promoted R14’s skin integrity.  CMS Ex. 3 at 20; see also CMS Ex. 15 ¶ 18; Tr. 49.  Further, the use of the Hoyer lift was safer for R14 in general because an OT determined, over the course of multiple sessions, that R14 failed to meet the goal of safely transferring with the sit-to-stand device but could transfer with a Hoyer lift.  CMS Ex. 7 at 3.  Therefore, there was a risk of more than minimal harm befalling R14 should a single staff member transfer R14 with a sit-to-stand device, regardless as to whether such harm occurred. 

Further, for the following reasons, I do not fully credit the testimony of Nurse Rader and Dr. Pecora: 

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• Nurse Rader acknowledged that the April 2021 MDS indicated R14 needed extensive assistance (i.e., assistance by two staff members) but did not acknowledge that the June 23, 2021 transfer by a single staff member meant that the transfer was improperly made.  P. Ex. 5 ¶ 17; P. Ex. 9 at 4; CMS Ex. 6 at 13.
• Nurse Rader’s description of R14’s care plan failed to mention that a May 2021 intervention in the care plan required a Hoyer lift with a two-person assist for transfers.  CMS Ex. 4 at 8; P. Ex. 9 at 4; CMS Ex. 4 at 8.  Dr. Pecora also avoided the question as to whether R14’s care plan had been violated by the June 23, 2021 transfer because he “defer[ed] to the review performed by Gail Rader.”  P. Ex. 8 ¶ 30.  However, as stated above, Nurse Rader ignored the most important provision in the care plan for this case.
• Nurse Rader’s description of the June 2021 hospital records for R14 fails to recognize that hospital staff found R14 had a hematoma and that it was likely caused by trauma.  P. Ex. 9 at 4-5; P. Ex. 5 ¶¶ 27, 38; CMS Ex. 19 at 10, 39.  
• Although Nurse Rader acknowledged that the facility investigation of the June 23, 2021 transfer from the shower chair to wheelchair was made by one staff member using a sit-to-stand device, the staff member did it because she could not find another staff member to assist, that the investigation “concluded Resident # 14 probably sustained the bruising from the support strap that goes under the armpits during the transfer,” and that “[t]he CNA was immediately counseled and re-educated,” Nurse Rader did not explain why she rejected these findings or conclusions.  P. Ex. 5 ¶¶ 33-34; P. Ex. 9 at 6.
• Dr. Pecora also did not explain why the facility’s findings and conclusions were wrong.  Dr. Pecora contradicts Petitioner’s final investigative findings on July 21, 2021, i.e., the bruise was caused “when the aide transfer[ed] without another[’s] assistance using the seat to stand lift.”  CMS Ex. 3 at 7.  Finally, Dr. Pecora’s opinion that the June 2021 bruise may not have been caused by trauma contradicts the hospital physician’s assessment that R14’s mass was “likely consistent with a hematoma. . . .  Likely traumatic.”  CMS Ex. 19 at 10. 

While it is not necessary for CMS to prove that the bruise on the left axilla and breast was caused by the sit-to-stand device on June 23, 2021, the nurse surveyor who investigated the deficiency provided testimony that supports the facility’s original conclusion that it was.  Dina Nicole Hebert, R.N.,8  testified that the sit-to-stand device uses straps that go under the resident’s arms while the Hoyer lift’s strap goes underneath the resident: 

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A.  It’s called sit-to-stand transfer device, that’s what was utilized in lieu of the [Hoyer] lift which does not use straps under the arm, would not put any pressure on the arms or under the arms or chest region. 

Q.  What does the Hoyer lift use to secure a resident? 

A.  A Hoyer lift usually a canvas almost like a tarp type of device, and it actually looks like a sling.  So when it’s placed, usually placed on the bed beneath the resident, when it picks them up, it kind of scoops them up and cocoons them so that they’re kind of almost, like, their arms stay within that tarp or whatever you want to call it they use, the canvas, so within the canvas area.  So they’re totally kind of cocooned in there when it’s picked up -- when they’re actually picked up, and they’re able to be transferred through the mechanical Hoyer lift over into a chair, usually.  Usually they’ll send them to a chair or wheelchair. 

* * * * *

Q.  All right.  Now does the sit-to-stand device, does that put pressure on the shoulder or under the arms? 

A.  It does. 

Q.  Does the Hoyer lift as well? 

A.  It does not. 

Q.  Okay.  Can you explain? 

A.  Well straps are utilized.  Straps are utilized that go around the resident’s under the arms.  Where the Hoyer lift, it’s a pad placed underneath of the resident, and the resident kind of folds their arms across their chest.  And as the machine lifts, it kind of envelopes them if that makes sense, so that there is no pressure to the upper body. 

Q.  So the sit-to-stand uses straps? 

A.  Correct. 

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Tr. 20-21, 100.  Based on Nurse Hebert’s investigation, she described how the bruising went from the chest wall and over to the axillary area (armpit area) and also around to the back.  Tr. 19-20.  This description led Nurse Hebert to conclude that the improper transfer with the sit-to-stand device resulted in that bruise.  Tr. 20.  While on cross-examination Nurse Hebert agreed that there could be other causes for the bruising, the fact remains that the facility’s determination that the sit-to-stand device, with its straps going under the arms of R14 so as to pull her to standing upright, likely caused the bruise is supported by the record, and Petitioner’s efforts to disprove its own conclusion are insufficient for me to find that Petitioner had been in substantial compliance. 

42 C.F.R. § 483.80(a) Deficiency

3.  R2 was a 90-year-old resident who required daily cleansing and new dressings for his various wounds.  On September 7, 2021, an R.N. with the facility cleaned and applied new dressings to R2’s wounds.  During this time, the R.N. picked up R2’s bed control and adjusted the bed and picked a plastic bag off the ground.  Without changing her gloves, the R.N. took gauze from a cup containing normal saline solution, separated one piece of gauze from the rest of the gauze, returned the remaining gauze to the cup, and used the piece of gauze she had retrieved from the cup to clean one of R2’s wounds.  After cleaning the wound, the R.N. removed her gloves and cleaned her hands.  After putting a new pair of gloves on, the R.N. took another piece of gauze from the cup and cleaned another wound.  The R.N. removed her gloves and cleaned her hands.  Without putting on new gloves, the R.N. applied bacitracin to a piece of gauze and applied the bacitracin to one of R2’s wounds without wearing gloves. 

During the relevant events in this case, R2 was a 90-year-old male who had been admitted to the facility in 2017.  CMS Ex. 9 at 1-2.  R2’s admitting diagnosis was Parkinson’s Disease and dysphagia; however, other diagnoses included:  abnormal weight loss; nonrheumatic aortic stenosis; and transient cerebral ischemic attack.  CMS Ex. 9 at 1.  Following R2’s admission to Petitioner’s facility, he was admitted to a hospital four times, always returning to Petitioner’s facility.  CMS Ex. 9 at 2. 

Starting in September 2019, Petitioner’s staff conducted skin assessments on R2 twice per week.  CMS Ex. 9 at 42.  At the time of the state agency survey in this case, R2 was receiving the following wound care: 

• August 29, 2021 order required staff to “[c]leanse left gluteal wound with [normal saline solution (NSS)].  Apply Bactroban ointment to the left gluteal wound daily, and cover with dry dressing.”  CMS Ex. 9 at 46. 

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• September 2, 2021 order required staff “one time daily” to “cleanse wound on the right ear with normal saline, pat dry, apply bacitracin zinc daily, then leave to open air.”  CMS Ex. 9 at 47, 59.
• September 2, 2021 order required staff to “cleanse wound on left upper wrist with NSS, pat dry, apply bacitracin zinc and cover with dry dressings daily.”  CMS Ex. 9 at 48.
• September 7, 2021 order requiring staff to “cleanse left forearm/lateral and elbow wound with NSS, pat dry, apply bacitracin zinc, then cover with [abdominal pad dressing], wrap with kling daily.”  CMS Ex. 9 at 48. 

State agency surveyor, Georgette Spiecker, R.N.,9  testified that, during the state agency survey, she witnessed the following: 

On August 31, 2021 at 11:39 a.m., I observed Resident # 2, nonverbal, seated in a recliner chair in his/her room, with a dressing to the left elbow and left wrist. 

* * * * *

On September 7, 2021 at 9:46 a.m., I watched the Registered Nurse perform wound treatments on Resident # 2 and observed the following:  I observed the RN remove a pair of metal scissors from her pocket.  She applied alcohol-based hand rub (“ABHR”) on a piece of gauze, rather than disinfectant wipes, cleaned the scissors and placed them on the over bed table.  She then donned gloves and used the scissors to remove the dressing from Resident # 2’s left elbow. The RN removed her gloves, without performing hand hygiene, walked to the treatment cart, reached into her pockets for the keys to open the cart, and removed a roll of one inch tape.  She placed the tape on the overbed table with the other wound care supplies.  She then performed hand hygiene and donned gloves.  CMS Ex. 14 at 1.  

The RN, with gloved hands, used the bed controller to elevate the resident’s head.  She picked up a plastic garbage bag that had fallen on the floor.  The RN, without changing gloves or

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performing hand hygiene, removed a piece of 4 x 4 gauze from a cup that contained normal saline solution and several other pieces of 4 x 4 gauze in it.  This essentially contaminated all the gauze in the cup.  Wearing the same gloves, when she should have changed them, the RN removed the gauze from the cup and separated one piece of gauze.  She then returned the remaining gauze to the cup and cleansed the skin tear on the left elbow.  She removed the gloves and performed hand hygiene.  CMS Ex. 14 at 1-2.  

The RN donned gloves, then removed a piece of gauze from the same cup that was already contaminated and cleansed the skin tear on the left wrist.  She removed the gloves and performed hand hygiene.  She opened a bacitracin packet and squeezed the bacitracin on a piece of folded gauze.  The RN did not put on gloves before applying the gauze to Resident # 2’s skin tear and covering the skin tear with a non-adherent dressing.  CMS Ex. 14 at 1-2.  

CMS Ex. 17 ¶¶ 2, 7-9. 

4.  Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1)-(2) because facility staff failed to implement Petitioner’s ICP.  The ICP required facility staff to wear a clean pair of gloves when cleaning wounds, performing treatments, and redressing wounds.  The RN who provided wound care for R2 wore gloves that had been contaminated by touching a bed control and a bag that had fallen to the floor, and the RN applied bacitracin to one of R2’s wounds without wearing any gloves. 

The Social Security Act states that an SNF must: 

Establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection. 

42 U.S.C. § 1395i-3(d)(3)(A); see also 42 C.F.R. § 483.80.  The Secretary’s regulations require facilities to establish and maintain an infection prevention and control program that includes, among other things, a “system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards.”  42 C.F.R. § 483.80(a)(1). 

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The statutory and regulatory injunction to “establish and maintain” an ICP requires SNFs to not only adopt an appropriate ICP, but also to implement the program’s prescribed precautions.10   Golden Living Ctr. - Superior, DAB No. 2768 at 7 (2017) (citing Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014)). 

CMS alleged a deficiency because Petitioner’s staff “failed to maintain infection control standards and procedures to address the risk of infection transmission by failing to perform a wound treatment in a safe and sanitary manner for 1 of 1 nurse observed providing a wound care treatment to 1 of 1 residents, (Resident # 2).”  CMS Ex. 1 at 33; CMS Ex. 17 ¶ 3.  

Petitioner’s policy on wound and skin care has a section on Infection Control Guidelines.  CMS Ex. 11 at 4.  These guidelines require the use of the “clean technique” when performing dressing changes.  CMS Ex. 11 at 4.  Petitioner has a Clean Dressing Competency, which is a step-by-step list of actions the R.N. should take when providing wound care.  CMS Ex. 10; CMS Ex. 11 at 5.  That Clean Dressing Competency indicates that at each step of the process, the removal of gloves, hand washing with soap and water, and putting on a pair of clean gloves is necessary.  CMS Ex. 10; CMS Ex. 11 at 5.  In testimony, Nurse Spiecker contrasted sterile and clean techniques noting that “even with a clean treatment, you’re not supposed to touch other items, and you’re not supposed to perform wound care without wearing gloves.  It’s just standard practice that you wear gloves.”  Tr. 140-141. 

Petitioner asserts that the R.N. cleaned her hands and replaced her gloves numerous times while cleaning R2’s wounds on the day that Nurse Spiecker was making observations during the survey and that it was highly unlikely that R2 was placed at risk.  P. Br. at 19-22; P. Ex. 5 ¶ 48.  Petitioner argues that the wound treatments for R2 were not sterile treatments.  P. Br. at 23.  Petitioner relies on the opinion of its expert witness, Nurse Rader, to prove that the R.N. conducting R2’s wound care acted under acceptable standards of practice and did not expose R2 to the risk of infection.  P. Br. at 23; P. Ex. 5 ¶ 59. 

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In her testimony, Nurse Rader acknowledged that the R.N. failed to wear gloves, but asserted that the R.N. did not appear to touch R2’s skin with her hands and, in any event, the R.N. had just washed her hands.  P. Ex. 5 ¶ 51; P. Ex. 9 at 9.  Nurse Rader opined that it was highly unlikely that R2 was placed at risk for infection and that the R.N. met acceptable standards of practice.  P. Ex. 5 ¶¶ 55, 59; P. Ex. 9 at 9-10. 

Dr. Pecora also testified that the R.N. met acceptable standards of practice while providing wound care to R2.  P. Ex. 8 ¶ 11.  Dr. Pecora deferred to Nurse Rader’s assessment and agreed with her that R2 did not require sterile treatment procedures.  P. Ex. 8 ¶¶ 39-41. 

While the R.N. appears to have generally been trying to comply with Petitioner’s ICP, there is no doubt that the R.N. failed to follow the requirements during the entire wound care episode that was observed.  Although Petitioner’s witnesses say that the R.N.’s failure to have gloves on when completing some wound care was not significant because she had washed her hands and apparently made no direct contact with R2’s skin, the R.N. still violated the ICP.  Further, although Nurse Rader acknowledged that the R.N. had touched R2’s bed controller and had not changed her gloves before providing care, she did not explain how these actions comported with Petitioner’s ICP or were not potentially placing R2 at risk.  P. Ex. 5 ¶ 48. 

On cross-examination, Nurse Spiecker explained exactly what she saw when R.N. failed to change her gloves: 

When she touched the bed controller and picked something up off the floor, those gloves are no longer clean.  And she went into the cup with both of the hands because the – when she prepared the cup with the saline with the gauze pieces, they were all together.  So she just needed one.  So she went into the cup, wringed it out, got the one gauze.  There, you know, and it was contaminating the liquid, the normal saline and the other gauze and the gauze that she was now holding in her hand. 

Tr. 128.  Nurse Spiecker observed the R.N. putting both of her gloved hands in the cup that had the gauze so that she could separate a single piece of gauze from the rest.  Tr. 146-47.  Although the R.N. then washed her hands and donned new gloves, the R.N. continued to apply contaminated gauze from the cup of saline liquid.  Tr. 129.  Nurse Rader likely did not explicitly defend this action by the R.N. because it is clear that the R.N. contaminated the gauze used to clean R2’s wounds.  Tr. 147; CMS Ex. 17 ¶ 8.  That contamination posed a risk of infecting the R2’s wound. 

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The Medicare infection control requirement has, as its basic goal, to “help prevent the development and transmission of disease and infection.”  42 U.S.C. § 1395i-3(d)(3)(A); see also 42 C.F.R. § 483.80.  The R.N.’s action did not further that goal. 

Remedy

5.  Petitioner did not dispute any of the regulatory factors used to set the CMPs in this case; therefore, I uphold the CMP amounts. 

Petitioner disputes the imposition of CMPs in this case. 

When determining whether a CMP amount is reasonable, I am to apply the factors listed in 42 C.F.R. § 488.438(f).  The regulations leave the decision regarding 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).  There is a “presumption that CMS has considered the regulatory factors in setting” the CMP amount and that those factors support the CMP.  Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002). 

CMS imposed two per-instance CMPs on Petitioner:  $11,300 for the 42 C.F.R. § 483.25(d) deficiency; and $5,000 for the 42 C.F.R. § 483.80(a) deficiency.  CMS Ex. 2 at 2.  The amounts are within the authorized range for a per-instance CMP.  Petitioner argues that the CMPs should be removed because the alleged deficiencies are not supported by evidence.  P. Br. at 30.  However, Petitioner did not further explain why the CMP amounts were not reasonable based on the regulatory factors for determining the amount of CMPs. 

As explained above, I have upheld the alleged deficiencies in this case.  Therefore, I reject Petitioner’s argument as to why I should reverse the CMPs that CMS imposed.  Because Petitioner did not dispute any of the regulatory factors related to the amount of the CMPs in this case, I uphold the CMP amounts imposed by CMS. 

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V.  Conclusion

For the reasons set forth above, I affirm CMS’s initial determination.