Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Aledo Rehab & Health Care Center,
(CCN: 145886),
Petitioner,
v.
Centers For Medicare & Medicaid Services.
Docket No. C-21-1107
Decision No. CR6775
DECISION
Petitioner, Aledo Rehab & Health Care Center, is a long-term care facility located in Aledo, Illinois, that participates in the Medicare program. In February and March 2021, the Illinois Department of Public Health (state agency) conducted three surveys: a February 25, 2021 annual health survey; a March 3, 2021 Life-Safety Code (LSC) survey which also included an Annual Emergency Preparedness (AEP) survey; and a March 3, 2021 complaint investigation.
In a letter dated March 11, 2021, and stemming from the February 25, 2021 annual health survey, the state agency determined that the facility was not in substantial compliance with Medicare program requirements. As a result, the Centers for Medicare & Medicaid Services (CMS) authorized the state agency to impose a Discretionary Denial of Payment for new Medicare and/or Medicaid Admissions (DPNA), effective March 26, 2021, a Directed Plan of Correction (DPOC) and Directed In-service Training (DIT). The state agency also notified Petitioner that it was recommending that CMS impose a Federal Civil Money Penalty (CMP) and Termination of its Provider agreement, effective August 25, 2021. Petitioner did not appeal.
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In another notice dated March 11, 2021, and based on the March 3, 2021 LSC and AEP survey, the state agency informed Petitioner of additional deficiencies at its facility. However, the state agency advised that no additional remedies would be imposed due to these violations and that all timelines and remedies within the initial notice would remain in effect. The record does not contain any evidence that the state agency imposed remedies based on the findings of its March 3, 2021, complaint investigation.
CMS later imposed, based on all the deficiencies identified in the three surveys, a CMP of $1,945.00 per day for 31 days from February 22, 2021, through March 24, 2021, for a total penalty of $60,295.00. Petitioner timely appealed the CMP.
As discussed below, I find that I do not have jurisdiction to review the deficiencies cited at Tags F758 and F880 based on Petitioner’s failure to timely appeal the March 11, 2021 notice, in which remedies were imposed for those deficiencies. With respect to the remaining deficiencies, I find that Petitioner was not in substantial compliance with Medicare program requirements and that the amount of the CMP is reasonable.
I. Background
The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions. Act § 1819. The Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.” 42 C.F.R. § 488.301.
The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a); 42 C.F.R. § 488.20. Each facility must be surveyed annually and surveyed more often, if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a) and 488.308. The state agency must also investigate all complaints. Act § 1819(g)(4).
The Secretary has delegated to CMS and the states the authority to impose remedies against a skilled nursing facility (SNF) that is not in substantial compliance with federal participation requirements. 42 C.F.R. §§ 488.400, 488.402(b). CMS has the burden to produce evidence sufficient to make a prima facie case that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy. See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). If CMS makes this prima facie showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied. In other words, Petitioner must show, by a
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preponderance of the evidence on the record as a whole, that it was in substantial compliance with participation requirements. Id.
The February 25, 2021 annual survey. From February 22, 2021 through February 25, 2021, state agency surveyors completed an annual survey. The surveyors found the facility was not in substantial compliance with the following program requirements:
- 42 C.F.R. § 483.10(c)(6),(8), (g)(12)(i)-(v) (Tag F578 – right to request, refuse and/or discontinue treatment) cited at scope and severity (s/s) level D (isolated instance of noncompliance that causes no actual harm with the potential for more than minimal harm)
- 42 C.F.R. § 483.21(b)(1) (Tag F656 – develop/implement comprehensive care plan) cited at s/s level D
- 42 C.F.R. § 483.21(b)(2)(i)-(iii) (Tag F657- care plan timing and revision) cited at s/s level D
- 42 C.F.R. § 483.24(c)(1)(Tag F679 – activities meet interest/need of each resident) cited at s/s level E (pattern of substantial noncompliance that causes no actual harm with the potential to cause more than minimal harm)
- 42 C.F.R. § 483.25(b)(1)(i),(ii) (Tag F686 – treatment to prevent/heal pressure ulcer) cited at s/s level G (isolated actual harm that is not immediate jeopardy)
- 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689 – free of accidents and hazards), cited at s/s level G
- 42 C.F.R. § 483.25(e)(1)-(3) (Tag F690 – bowel/bladder care) cited at a s/s level D
- 42 C.F.R. § 483.25(l) (Tag F698 - dialysis) cited at a s/s level D
- 42 C.F.R. § 483.40(b)(3) (Tag F744 – treatment/service for dementia) cited at a s/s level D
- 42 C.F.R. § 483.45(c)(3)(e)(1)-(5) (Tag F758 – free from unnecessary psychotropic medicine) cited at a s/s level D
- 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880 - infection control and prevention program) cited at a s/s level E, and
- 42 C.F.R. § 483.80(d)(1)(2) (Tag F883 - Influenza and Pneumococcal Immunizations) cited at a s/s level D
CMS Ex. 1; CMS Ex. 3. On March 11, 2021, the state agency issued an initial determination notifying Petitioner of the deficiencies. CMS Ex. 3. The notice also informed Petitioner that the state agency was imposing, as authorized by CMS, a DPNA, effective March 26, 2021, a DPOC and DIT. Id. at 2-4. The state agency also notified Petitioner that it was recommending that CMS impose a CMP and Termination of its Provider agreement (termination), effective August 25, 2021, and that CMS would separately send a written notice of such remedy and appeal rights if it chose to impose additional remedies. Id.
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Because remedies were imposed, the March 11, 2021 notice provided Petitioner with “Formal Appeal Rights” if it “disagree[d] with this action imposed on your facility.” Id. at 4-5. The notice clearly stated, “A request for hearing must be filed no later than sixty (60) days from the date of receipt of this notice.” Id. at 5. Petitioner did not appeal this notice.
The March 3, 2021 LSC survey. Surveyors returned to the facility and completed an LSC survey which also included an AEP survey. CMS. Exs. 32-33. During the LSC survey, the state agency identified 15 deficiencies:
- K291 (s/s F) (emergency lighting)
- K293 (s/s F) (exit signage)
- K321 (s/s E) (hazardous areas – enclosure)
- K341 (s/s F) (fire alarm system – installation)
- K345 (s/s F) (fire alarm testing – testing and maintenance)
- K346 (s/s F) (fire alarm system – out of service)
- K353 (s/s F) (sprinkler system – maintenance and testing)
- K354 (s/s F) (sprinkler system – out of service)
- K355 (s/s F) (portable fire extinguishers)
- K363 (s/s E) (corridor – doors)
- K711 (s/s F) (evacuation and relocation plan)
- K712 (s/s F) (fire drills)
- K741 (s/s F) (smoking regulations)
- K915 (s/s F) (electrical system – essential electrical system) and
- K918 (s/s F) (electrical system – essential electrical system)
CMS Ex. 32. Moreover, the state agency identified 19 additional deficiencies during the AEP survey:
- E004 (s/s F) (develop emergency preparedness (EP) plan)
- E007 (s/s F) (EP program patient population)
- E013 (s/s F) (development of EP policies and procedures)
- E015 (s/s F) (subsistence needs)
- E018 (s/s F) (tracking procedures)
- E022 (s/s F) (shelter in place policies and procedures)
- E023 (s/s F) (medical documentation policies and procedures)
- E024 (s/s F) (volunteers and staffing policies and procedures)
- E025 (s/s F) (arrangement with other facilities)
- E029 (s/s F) (development of communication plan)
- E030 (s/s F) (names and contact information)
- E031 (s/s F) (emergency officials contact information)
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- E032 (s/s F) (primary/alternate means of communication)
- E034 (s/s F) (information on occupancy/needs)
- E035 (s/s F) (sharing plans with patients)
- E036 (s/s F) (EP training and testing)
- E037 (s/s F) (EP training program)
- E039 (s/s F) (EP testing requirements) and
- E041 (s/s F) (emergency power)
CMS Ex. 33.
On March 11, 2021, the state agency notified Petitioner of the deficiencies found during the LSC survey. CMS Ex. 36. The notice further incorporated by reference the remedies proposed in the annual survey notice, which was also dated March 11, 2021. Id. at 1 (citing CMS Ex. 3). The LSC notice specifically stated:
- Although no additional remedies will be recommended or imposed as a result of the revisit, all remedies proposed, recommended or imposed in the “Initial Notice” and any subsequent notices will continue in effect. Time lines and effective dates established in the “Initial Notice” or any amendments thereto remain unchanged.
CMS Ex. 36 at 1. Petitioner did not file an appeal of the March 11, 2021 LSC notice.
The March 3, 2021 complaint investigation survey. Surveyors also completed a complaint investigation survey, and found an additional deficiency:
- 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689) cited at s/s level D
CMS Ex. 24. There is no documentation in the record suggesting that the state agency imposed a remedy for this violation.
CMS’s July 29, 2021, imposition of remedies. On July 29, 2021, CMS issued a notice letter reminding the facility of the state agency’s findings of substantial noncompliance, the remedies the state agency imposed, and that it was previously notified of its appeal rights. CMS Ex. 4. Regarding the previously imposed remedies, the letter stated that the DPNA and termination did not go into effect, and that the DIT and DPOC were imposed and completed. Id. at 2. In addition to these remedies, CMS advised Petitioner that, based on all of the deficiencies cited, it was imposing a CMP of $1,945.00 per day for 31 days from February 22, 2021, through March 24, 2021, for a total of $60,295.00. Id. Also, because the total CMP was more than $11,160.00, the notice advised Petitioner that it was subject to a Nurse Aide Training and/or Competency Evaluation Program
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(NATCEP) prohibition for two years. Id. at 4. Finally, Petitioner was advised of its right to appeal if it “disagreed with the findings of noncompliance, which resulted in this imposition.” Id. at 4-5.
In a letter dated September 24, 2021, Petitioner requested a hearing, challenging all the deficiency findings (from all three surveys), and appealing the CMP. See CRD Dkt. Entry No. 1. This case was originally assigned to Administrative Law Judge (ALJ) Bill Thomas and reassigned to me on August 1, 2024.
The parties’ submissions. On December 27, 2021, CMS filed a motion for summary judgment and prehearing brief (CMS Br.) and 48 exhibits. Petitioner filed its prehearing brief and response to CMS’s motion (P. Br.), along with 8 exhibits. Petitioner also reserved the right to cross-examine each of CMS’s proposed witnesses. Neither party objected to the exhibits proposed by the other; therefore, I previously admitted them all into the record. CRD Dkt. Entry No. 67.
On January 22, 2025, I issued an Order Directing Parties to Submit Supplemental Briefing. CRD Dkt. Entry No. 65. I directed the parties to submit briefing addressing my authority to review the findings of substantial noncompliance in this case considering Petitioner’s failure to request a hearing on those findings within 60 days from receipt of the notice of initial determination, i.e., the state agency’s March 11, 2021 notice. CRD Dkt. Entry No. 65. On February 28, 2025, CMS timely submitted its brief, arguing that when CMS issued its initial determination imposing its additional remedy – the per-day CMP – the findings of noncompliance from all three surveys became reviewable. CRD Dkt. Entry No. 66. Petitioner did not submit a supplemental brief.
On April 25, 2025, the parties submitted a joint filing wherein Petitioner waived its right to cross-examine CMS’s witnesses and both parties requested a decision on the written record. CRD Dkt. Entry No. 69.
II. Issues
Whether I have jurisdiction to review the deficiencies cited at Tags F758 and F880 based on Petitioner’s failure to timely appeal the March 11, 2021 notice letter.
Whether Petitioner was in substantial compliance with the remaining deficiencies cited in the February and March surveys.
If Petitioner was not in substantial compliance, whether the amount of the CMP imposed is appropriate under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).
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III. Discussion
- 1. Petitioner is not entitled to a hearing challenging the deficiencies cited under Tags F758 and F880 because it did not timely file a request for hearing.1
On January 22, 2025, I directed the parties to submit briefing addressing my authority to review the findings of substantial noncompliance in this case considering Petitioner’s failure to request a hearing on those findings within 60 days from receipt of the notice of initial determination, i.e., the state agency’s March 11, 2021 notice. CRD Dkt. Entry No. 65.
Pursuant to my independent obligation to ensure jurisdiction, I find that I do not have authority to review the deficiencies cited under Tag F758 and Tag F880 from the February 25, 2021 annual survey because those findings resulted in the imposition of remedies, which Petitioner did not timely appeal. Restoration Risk Retention Grp., Inc. v. Gutierrez, 880 F.3d 339, 345 (7th Cir. 2018). Besides those two deficiencies, I do have the authority to review the remaining deficiencies cited during the survey cycle.
Section 1866 of the Act authorizes administrative review of determinations that a provider fails to comply substantially with Medicare program requirements “to the same extent as is provided in section 205(b)” of the Act. Under § 205(b), the Secretary of Health and Human Services must provide reasonable notice and opportunity for a hearing “upon request by [an affected party] who makes a showing in writing that his or her rights may be prejudiced” by the Secretary’s decision. The request, “must be filed within sixty days” after receipt of the notice of CMS’s determination. Act § 205(b). The 60-day limit is thus a statutory requirement.
In accord with the statutory requirement, the implementing regulations require that an affected party “file [a] request [for hearing] in writing within 60 days from receipt of the notice of initial . . . determination . . . unless that period is extended.” 42 C.F.R. § 498.40(a)(2). Section 498.3 of the regulations identifies the types of actions considered “initial determinations” subject to administrative review. Initial determinations include, with respect to an SNF or NF, “the finding of noncompliance leading to the imposition of enforcement actions specified in § 488.406, § 488.820, or § 488.1170 of this chapter, but not the determination as to which sanction or remedy was imposed.” 42 C.F.R. § 498.3(b)(13); see also 42 C.F.R. 488.408(g) (“A facility may appeal a certification of noncompliance leading to an enforcement remedy.”). Among the remedies specified in § 488.406 are a DPOC, DPNA and DIT. 42 C.F.R. §§ 488.406(a)(2)(ii),(7),(8). The regulations further explain that, “[a]n initial determination is binding unless it is[,]” as pertinent here, “[r]eversed or modified by a hearing decision.” 42 C.F.R. § 498.20(b)(2).
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As noted, following the February 2021 survey, the state agency issued an initial determination dated March 11, 2021, notifying Petitioner of the deficiencies and that the state agency was imposing, as authorized by CMS, a DPNA, effective March 26, 2021, a DPOC and DIT. CMS Ex. 3 at 2-4. As CMS points out, however, the threatened DPNA did not go into effect because the facility returned to substantial compliance before the effective date. CMS Ex. 4 at 2. Thus, the only remedies that were imposed from that March 11 notice were the DPOC and the DIT. However, those remedies were specifically related to the tags cited under Tags F758 and F880 only. CMS Ex. 3 at 2 (specifying that the DIT covered “[u]se of psychotropic medications to include assessment for need and adverse drug reactions; gradual dose reductions and alternative behavioral interventions” which corresponds with Tag F758 and specifying that the DPOC was “for F880”).
Based on the Board’s reasoning, findings of substantial noncompliance that result in remedies being imposed become final and binding after a facility fails to submit an appeal within the timeframes established by statute and regulation. 42 C.F.R. § 498.20(b)(2); see Northlake Nursing and Rehab. Ctr., DAB No. 2376 at 5 (2011) (upholding ALJ dismissal of an untimely hearing request challenging noncompliance findings related to previously imposed remedies); see also Columbus Park Nursing and Rehab. Ctr., DAB No. 2316 at 7 (2010) (“[T]he Board has long held that a SNF or NF has no right to an ALJ hearing to contest survey deficiency findings where CMS has not imposed any of the remedies specified at section 488.406 based on those findings, or where CMS imposed, but subsequently rescinded, any such remedies.”).
Petitioner’s failure to timely appeal the March 11 notice or provide good cause to extend the filing deadline means that the deficiencies that resulted in the DPOC and DIT remedies – Tags F758 and F880 – are final and binding. Nevertheless, because no remedies were imposed for the remaining findings of noncompliance from the February 2021 survey until CMS’s July 2021 notice imposing a CMP “based on all of the deficiencies cited,” Petitioner’s failure to appeal the March 11 notice did not foreclose its later appeal of those remaining deficiencies.
- 2. The facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (F689) because Petitioner failed to follow its own policies for investigating the causes of R1’s falls and thus failed to address R1’s risk of falls.
Program requirement: 42 C.F.R. § 483.25(d) (Tag F689). The statute and regulation require that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care. Act § 1819(b)(2); 42 C.F.R. § 483.25.
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Quality of care “is a fundamental principle that applies to all treatment and care provided to facility residents.” 42 C.F.R. § 483.25. Based on the resident’s comprehensive assessment, “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the resident’s comprehensive, person-centered care plan, and the resident’s choices.” Id.
To this end, the “quality of care” regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistive devices to prevent accidents. 42 C.F.R. § 483.25(d). The facility must eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.” Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10 (2004), aff’d sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005); accord Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must “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.”). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances. 42 C.F.R. § 483.25(d); Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub nom. Windsor Health Care Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).
Where a facility policy or a resident’s care plan requires staff to take specific measures in caring for a resident, those measures reflect the facility’s own determination of what it must do to attain or maintain the resident’s “‘highest practicable physical, mental, and psychosocial well-being’ as required by the overarching quality-of-care requirement.” Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (quoting Azalea Court, DAB No. 2352 at 9 (2010)). The facility is not in substantial compliance with section 483.25(d) if, without justifiable reason, it does not implement the accident precautions that its staff has determined are necessary to mitigate foreseeable accident risks. Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 14 (2018).
Relevant Facts related to R1: R1 was admitted to Petitioner’s facility on June 18, 2020, following treatment in an acute care hospital. CMS Ex. 24 at 2; CMS Ex. 31 at 2. R1’s diagnoses included: non traumatic intracerebral hemorrhage, hemiplegia, hemiparesis, deformity of the head after a craniotomy and major depressive disorder. CMS Ex. 24 at 2. R1’s medical records reveal, that while admitted at Petitioner’s facility, she was found on the floor on both June 19, 2020 and June 28-29, 2020. Id.; CMS Ex. 31 at 1-4; CMS Ex. 44 at ⁋ 6. R1 was brought to the hospital following the June 19th fall. CMS Ex. 24 at 2. On March 9, 2021, a complaint investigation began after a relative of R1 notified the state agency that R1 “ha[d] been dropped four times out of the Hoyer lift and that she had a 60 pound weight loss due to staff not letting the residents at the facility eat or drink.” CMS Ex. 30 at 3; CMS Exs. 28, 31.
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The Facility’s Policy: Petitioner’s internal policy contains its responsibilities and procedures for falls. Specifically, Petitioner’s policy titled, “Fulfilling Fall Prevention Responsibilities” requires that following a fall, the Director of Nursing (DON) “[e]nsure understanding of fall cause through review of documentation.” CMS Ex. 20 at 67. The policy further requires that the Charge Nurse “[c]onduct a ‘Fall Huddle’ with staff after the fall to obtain important information about the fall to help identify the cause of the fall.” Id. Moreover, the Charge Nurse is required to complete forms, including the “Fall Documentation Worksheet and Investigative Report of Fall” and submit them to the DON. Id.
Petitioner’s Noncompliance: CMS argues that Petitioner failed to comply with 42 C.F.R. § 483.25(d)(1)-(2) when it ignored its own policy and did not investigate the cause of R1’s falls. CMS Br. at 20-21. CMS adds that Petitioner conceded to the state agency that it did not investigate the two incidents in which R1 was found on the floor. Id. (citing CMS Ex. 44 ¶ 6, 7). Petitioner responds that it complied with the regulations and, while it acknowledges R1 fell, argues that a “resident observed on the floor of their room is not necessarily indicative of a hazard being present in the room.” P. Br. at 11. Petitioner adds that there is no evidence that R1 “was not properly being supervised when these incidents occurred” and that it completed a Quality Care Reporting Form following the June 28th-29th incident, which revealed no injuries, and provided R1 with a low bed to prevent “climbing out of bed.” Id. (citing P. Ex. 6 at 3). Finally, while Petitioner does not state whether it conducted a “Fall Huddle” following the incidents, it states that its “investigation was limited due to these facts [i.e., the fall being unwitnessed and R1 being unable to answer questions] and interventions were put in place to prevent further events.” Id.
The Board has repeatedly held that CMS may reasonably rely on a facility’s protocols and treatment policies as evidencing the facility’s own judgment of the care and services that are necessary at a minimum to attain or maintain its residents’ highest practicable physical, mental, and psychosocial well-being. The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008) (“CMS may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being . . . .”); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013) (“[T]he Board has long held that a facility’s own policy may be sufficient evidence both of professional standards of quality and of what the facility has determined is needed to meet the quality of care requirements . . . .”). Specifically, a facility’s obligations under section 483.25 include furnishing the care and services set forth in its own resident care policies. Logan Healthcare Leasing, LLC, DAB No. 3036 at 14 (2021); Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012) (citing cases), aff’d, 535 F. App’x 468 (6th Cir. 2013); Life Care Ctr. of Tullahoma, DAB No. 2304 at 34 (2010) (the care and services required by section 483.25 include care and services called for by a facility’s resident care policy), aff’d, 453 F. App’x 610 (6th Cir. 2011); Good
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Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018) (section 483.25 obligates a skilled nursing facility to follow its own resident care policies). Indeed, “[o]nce a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents . . . the facility is held to follow through on them.” Heritage Plaza Nursing Ctr., DAB No. 2829 at 20 (2017).
CMS has shown that Petitioner failed to comply with its own internal policy after R1 fell on two occasions in its facility. Petitioner’s staff conceded to the state agency that it did not investigate the falls. CMS Ex. 44 (¶ 6). While Petitioner states that it conducted the Quality Care Reporting Form following the June 28-29, 2020 fall, there is no evidence it completed the other two forms (Fall Documentation Worksheet and Investigative Report of Fall) for the same fall; there is no evidence it completed any of the three forms for the first fall on June 19; and it has failed to put forth any evidence or argument that it conducted a “Fall Huddle” for either fall consistent with its written policy.
These facts establish that Petitioner failed to provide R1 with an environment that was free of accident hazards and failed to provide adequate supervision to prevent accidents. Fortunately, R1 did not sustain serious injuries, however, Petitioner’s staff considered the falls to be serious enough to require evaluation and medical treatment in the hospital. Had Petitioner conducted the required “Fall Huddle” after the initial incident, it may have been able to prevent the subsequent fall. Moreover, given R1’s medical condition, the falls posed a risk of more than minimal harm to health and safety. Given the facility’s failure to enforce its own policies regarding falls, it failed to comply with the requirements of 42 C.F.R. § 483.25(d).
- 3. The facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (F689) because Petitioner failed to address R17’s wheelchair protrusion before it caused the laceration to R17’s leg.
Relevant Facts related to R17: R17, 69 years old, was diagnosed with dementia, metabolic encephalopathy, weakness, and a history of falls. CMS Ex. 11 at 1, 3. Given R17’s fall risk, Petitioner developed a care plan that “require[d] monitoring and intervention to reduce [the] potential for self injury.” Id. at 22. In addition, because R17 used a wheelchair without footrests, the facility’s care plan included “[e]nsur[ing] that adaptive devices” are “within reach and in good repair.” Id.
On January 25, 2021, R17 was transferred to the emergency room after sustaining a laceration and skin tear on her leg. Id. at 9-10. The state agency worksheet indicated that R17 was injured because “the area where foot pedals would connect to wheelchair protruded out and caused injury.” Id. at 1, 5-6. As a result of the injury, R17 received 11 sutures in her left leg. Id. Petitioner thereafter padded R17’s wheelchair pedal connectors. Id.
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Petitioner’s Noncompliance: CMS argues that Petitioner failed to comply with 42 C.F.R. § 483.25(d) “because it did not take all reasonable steps to provide the supervision and assistance devices necessary to prevent a foreseeable accident, and as a result, R17 injured her leg on her wheelchair.” CMS Br. at 14. CMS further argues that Petitioner “failed to ensure that R17’s environment remained free from accident hazards when it failed to ensure that R17’s wheelchair was in good repair.” Id. Petitioner disputes CMS’s characterization of the events regarding R17 and claims that they do not support a finding of noncompliance. P. Br. at 6-7. Specifically, Petitioner argues that R17 was “properly supervised by staff” and “it is not reasonable to assume that staff would always be able to intervene prior to an accident occurring.” Id.
The facts above establish that Petitioner failed to provide R17 with an environment that was free of accident hazards and failed to provide adequate supervision to prevent foreseeable accidents. Petitioner was aware of R17’s medical diagnoses and impaired cognition. CMS Ex. 11 at 12. Petitioner further knew of R17’s risk of falls and potential for self-injury while using her wheelchair without the use of foot pedals because she would propel herself using her feet. Id. at 1, 22 (care plan noting resident has risk factors that require monitoring and intervention to reduce potential for self-injury, including medical conditions, sensory alterations, balance, gait, assistive devices, cognition, mood/behavior, safety awareness, compliance, and medications). As a result, Petitioner developed a care plan for R17 that included ensuring that her wheelchair was in good repair and to assist in placement of non-skid footwear. Id. at 22.
Despite the care plan’s requirements, Petitioner failed to address or repair R17’s wheelchair, which had a protrusion and caused an injury to her leg. Id. at 1-6. R17’s injury was serious enough to warrant transfer to an emergency department where 11 sutures were required to close the wound. Id. Notably, in an interview, the facility’s administrator acknowledged that “there is a piece of her wheelchair that protrudes where the foot pedal would go,” and maintenance and certified nursing aides “should be checking the wheelchairs for things like this.” CMS Ex. 1 at 21-22; CMS Ex. 42 at 4 (⁋ 9). CMS also submits unrebutted testimony from the surveyor that “[i]f facility staff had checked R17’s wheelchair, they could have fixed it immediately by placing padding over the sharp object or providing her with a different wheelchair to use that day.” CMS Ex. 42 at 4 (⁋ 9).
The Board has repeatedly held that 42 C.F.R. § 483.25(d) requires the facility to “provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.” Century Care of Crystal Coast, DAB No. 2076, at 6-7 (2007), aff’d, Century Care of Crystal Coast v. Leavitt, 281 F. App’x 180 (4th Cir. 2008). Thus, by failing to address the foreseeable risk of accident from the protrusion in R17’s wheelchair, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2).
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- 4. The facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) because Petitioner failed to follow orders and the care plan for R31.
Relevant Facts related to R31: Upon admission in October 2020, R31, was 67 years old and diagnosed with unspecified dementia and non-pressure chronic ulcer. CMS Ex. 16 at 1. R31’s care plan dated October 22, 2020 required that a Braden Risk Assessment be conducted weekly for a period of four weeks following admission and then on a quarterly basis. Id. at 17. In addition, the care plan indicated that a nurse would “measure and monitor wound status progression or deterioration [once a] week.” Id. at 20. Medical records show that R31’s Braden Risk Assessments were performed on October 22, 2020, December 15, 2020, and January 8, 2021. Id. at 15-16. For the three assessments, R31 was noted to be moderately at risk for pressure ulcers. Id.
R31’s care plan further required weekly skin checks with documentation and skin checks on a daily basis during cares and bath/shower. Id. at 17-18. The record, however, does not contain any documentation that R31 received these skin checks. In January 2021, R31 developed a pressure injury on her right heel. Id. at 29-31. Further, R31’s physician issued a February 17, 2021 order to apply alginate to R31’s right heel pressure wound; nevertheless, the state surveyor learned that this order was not followed during R31’s wound treatment on February 23, 2021. CMS Ex. 1 at 18; CMS Ex. 40 at 4-5.
Program requirement: 42 C.F.R. § 483.25(b)(1) (Tag F686). “Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.” 42 C.F.R. § 483.25.
Under the statute and the quality-of-care regulation, each resident must receive, and the facility provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being in accordance with the resident’s comprehensive assessment and plan of care. Act § 1819(b); 42 C.F.R. § 483.25. To this end, the facility must (among other requirements) ensure that a resident who enters the facility without pressure sores does not develop them unless the resident’s clinical condition shows that they were unavoidable, based on a comprehensive assessment. 42 C.F.R. § 483.25(b)(1)(i). If the resident already has pressure sores, the facility must ensure that he/she receives the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. § 483.25(b)(1)(ii).
In assessing the facility’s compliance with this requirement, the relevant question is: did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent new sores from developing? If it did so, and the resident develops sores anyway, I could find no deficiency. But if the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation. Heritage House of Marshall Health & Rehab., DAB No. 3035 at 11-12 (2021) (“[A] facility cannot claim
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unavoidability unless it first shows that it furnished all necessary treatment and services.”); Fireside Lodge Ret. Ctr., DAB No. 2794 at 12 (2017) (holding that the issue was not whether a pressure sore could be expected to heal, but rather whether the facility staff provided the care and services necessary to promote healing); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. HHS, 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB 1750 at 32 (2000).2
Facility policy: Preventative Skin Care. The facility had a policy requiring preventative measures in order to keep residents “free from pressure ulcers” through “repositioning and careful washing, rinsing, drying, and observation of the resident’s skin condition.” CMS Ex. 20 at 3-4. The facility further instituted a policy entitled: Decubitus Care/Pressure Areas, in order to ensure proper treatment, monitoring, and healing of pressure ulcers. Id. at 5-6. Specifically, these polices required that:
- All residents will be assessed under the Braden Pressure Ulcer Scale at the time of admission and weekly x 4 then will be assessed at least quarterly and/or as needed.
- Upon notification of skin breakdown, the QA form for Newly Acquired Skin Condition will be completed and forwarded to the Director of Nurses. The pressure area will be assessed and documented on the Treatment Administration Record or the Wound Documentation Record. Complete all areas of the Treatment Administration Record or Wound Documentation Record.
- When a pressure ulcer is identified additional interventions must be established and noted on the care plan in an effort to prevent worsening or re-occurring pressure ulcers.
Id. at 3-5.
Petitioner’s noncompliance: CMS argues that Petitioner was not in substantial compliance with 42 C.F.R. § 438.25(b)(1) because it failed to provide care “in accordance with R31’s care plan, its own Preventative Skin Care and Decubitus Care/Pressure Areas Policies, and nursing standards of care to ensure that R31 did not develop new pressure ulcers and to treat existing areas.” CMS Br. at 16. Petitioner, however, disputes this contention and argues that the “development of this deep tissue
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injury was unfortunate, [and] it was likely unavoidable due to multiple co-morbidities and issues healing that R31 was experiencing.” P. Br. at 7-8.
Contrary to Petitioner’s arguments, the weight of the evidence in the record does not support that R31’s heel wound was “unavoidable due to multiple co-morbidities.” See id. While Petitioner relies on its Minimum Data Set Coordinator, who opined that R31’s pressure injuries and ulcers were “likely unavoidable,” she did not further explain the basis for that opinion. P. Ex. 2 at 2. Nor did she address the impact of Petitioner’s failure to follow its own care plan for R31. See id. Significantly, Petitioner does not dispute that it failed to follow R31’s care plan and her physician’s orders. Specifically, the record reflects that its staff only performed three Braden Scale Assessments over two and a half months, rather than the required weekly assessments over the first four weeks. CMS Ex. 16 at 15-17. Moreover, the facility did not provide any documentation that it even conducted weekly or daily skin checks consistent with its care plan. Id. at 17-18, 22-24 (nearly blank forms for October through December 2020). Following Petitioner’s failure to perform these assessments and checks, R31 developed a pressure injury on her right heel. Id. at 29-31. Lastly, Petitioner’s staff did not follow the physician’s orders and apply the alginate as required. CMS Ex. 1 at 18; CMS Ex. 40 at 4-5.
Because the facility did not follow the physician order or the care plan, it was not in substantial compliance with section 483.25(b)(1). Heritage House of Marshall, DAB No. 3035 at 19; Cedar Lake Nursing Home, DAB No. 2390 at 3 (2011) (holding that a facility’s failure to comply with physician orders, a resident’s care plan, or its own policies can constitute a deficiency under section 483.25); Woodland Village Nursing Ctr., DAB No. 2053 at 9 (2006), aff’d, Woodland Vill. Nursing Ctr. v. U.S. Dep’t. of Health & Hum. Servs., 239 F. App’x 80 (5th Cir. 2007) (citing Lakeridge Villa Health Care Ctr., DAB No. 988 at 22 (2005), aff’d, Lakeridge Villa Care Ctr. v. Leavitt, 202 F. App’x 903 (6th Cir. 2006).
- [W]here the facility is proven to have been providing improper care or not providing care as ordered by the physician or planned by the facility itself as necessary to protect against or treat pressure sores, CMS need not wait to see if an infection or aggravation of a sore ensues before citing a deficiency.
Woodland Village Nursing Ctr., DAB No. 2172 at 14 (2008) (emphasis added).
Because it failed to provide alginate, as ordered by the resident’s physician, or the skin checks and assessments, as developed in the care plan, the facility was not in substantial compliance with section 483.25(b)(1), and I sustain the deficiency.
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- 5. The facility was not in compliance with numerous LSC and AEP requirements.
Petitioner’s facility was surveyed on March 3, 2021, in order to assess its compliance with Life Safety Code requirements and Annual Emergency Preparedness. CMS Exs. 32, 33. The Life Safety Code of the National Fire Protection Association (NFPA) contains rules that address the conditions of a skilled nursing facility’s physical location. CMS Ex. 32 at 1. The intent of the code is to assure that a facility does not manifest conditions that are dangerous to the physical well-being of residents. The AEP is designed to ensure compliance with all applicable Federal, State and local emergency preparedness law. CMS Ex. 33 at 1.
The LSC survey determined that Petitioner was noncompliant in many respects with the Life Safety Code, including:
- Failing to provide a required directional emergency illuminated exit sign. CMS Ex. 33 at 4.
- Failing to maintain all Hazardous Room Doors and to ensure each automatically closes and latches to the door frame under the power of the automatic closer. Id. at 6.
- Failing to know where the Fire Alarm Breaker was located, to confirm the breaker was marked in “Red Markings” and to confirm the breaker was “secured.” Id. at 9.
- Failing to provide a complete required sensitivity test on all smoke detectors in the past 24 months. Id. at 12.
- Failing to conduct required Sprinkler System maintenance. Id. at 14.
- Failing to provide required monthly visual inspections for all fire extinguishers throughout the facility and to properly support all fire extinguishers. Id. at 18.
The AEP survey also disclosed that Petitioner was noncompliant in many additional respects, including:
- Failing to provide a policy and procedures to review and update the elements of the emergency plan every year. CMS Ex. 33 at 2.
- Failing to provide a document for patient populations at risk and continuity of operation documents for emergency events. Id. at 4.
- Failing to provide a policy to evacuate the building to protect residents, staff and others being sheltered-in-place or provide evidence the building environmental systems are connected to an alternate source of energy (emergency generator) when there is a loss of main electrical power or when there is a mechanical equipment failure for an extended period of time. Id. at 17.
- Failing to provide policies and procedures documents for emergency staffing strategies and volunteers during an emergency event. Id. at 21.
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Petitioner has not specifically contested any of these noncompliance findings in the LSC or the AEP surveys. See P. Br. at 11-12. In fact, Petitioner concedes that an evacuation drill did not occur in 2020 due to the COVID-19 pandemic and further acknowledges that “several key staff members were new to their roles at the facility” at the time of the surveys. Id. at 12. None of these general reasons excuses Petitioner’s failures.
Given that Petitioner does not raise any arguments to dispute these findings, I sustain these deficiencies.3
- 6. The remedy imposed is reasonable.
Determining whether the remedy is reasonable. To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f): (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) 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. The absence of culpability is not a mitigating factor. The factors 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.
I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the section 488.438(f) factors. I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion. Barn Hill Care Ctr., DAB No. 1848 at 21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1683 at 8 (1999).
I determine whether a penalty is reasonable, based on the per-day penalty, not the total accrued penalty. Copperas Cove LTC Partners, Inc., DAB No. 3049 at 43 (2021); Crawford Healthcare & Rehab., DAB No. 2738 at 20 (2016).
The burden is on the facility “to demonstrate, through argument and submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.” Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017) (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 26-27 (2011)).
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Penalties are inflation-adjusted and change annually. The amount is determined as of the date the penalty is assessed, in this case, July 29, 2021. CMS Ex. 3. Here, CMS imposed a per-day CMP of $1,945, which is at the low end of the range for per-day CMPs ($112 to $6,695). 42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).
Applying the regulatory criteria to this case. Considering the relevant factors, CMS has established that the relatively low CMP is reasonable.
History. The facility has a poor compliance history. The AEM Nursing Home Enforcement History shows, among other citations, prior deficiencies in quality-of-care and infection control; as well as repeated LSC violations. CMS Ex. 22 at 1-3. In fact, the prior violations of F689, F880, and F744, were at the D and F levels. Id. The facility’s significant noncompliance history justifies the CMP imposed.
I am mindful that on March 24, 2024, during the course of these proceedings, Petitioner filed a petition for relief under Chapter 11 of the United States Bankruptcy Code, 11 U.S.C. § 101, et seq., with the United States Bankruptcy Court for the District of Delaware. See CRD Dkt. Entry No. 62. However, Petitioner presents no evidence that its current financial condition affects its ability to pay the CMP. To meet the standard for reducing a CMP based on financial condition, claims must be supported by compelling financial documentation. Guardian Care Nursing & Rehabilitation Center, DAB No. 2260 (2009). Petitioner has not shown, nor even alleged, that the payment of the CMP would affect its ability to stay in business, and the evidence does not otherwise warrant reduction of the CMP based on Petitioner’s financial condition.
With respect to the remaining factors, this case involved multiple surveys and a significant number of deficiencies. I have discussed in significant detail the deficiencies above. Some of those deficiencies could have easily been avoided, including:
- Following a care plan and physician’s order to prevent and treat pressure sores
- Following a care plan and ensuring proper maintenance of a wheelchair and
- Following internal policies to investigate falls and prevent accidents
The facility is culpable for its staff’s failure to follow the physician’s orders, its care plans, and internal policies.
Finally, the surveyor found multiple LSC and AEP deficiencies. The problems included emergency preparedness, smoke detectors testing, and fire safety. CMS Exs. 32, 33.
Thus, considering the section 488.438(f) factors, a substantial penalty is justified. I therefore conclude that the low-end penalty imposed here is reasonable.
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Because I sustain the CMP, which is over the $11,160.00 threshold amount to trigger the NATCEP prohibition, I must also sustain the prohibition against conducting a NATCEP for two years. Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b), (f); 85 Fed. Reg. at 2886.
IV. Conclusion
The facility was not in substantial compliance with Medicare program requirements. The penalty imposed – $1,945 per day – is reasonable.
Benjamin J. Zeitlin Administrative Law Judge
- 1
My findings of fact and conclusions of law are set forth in bold and italicized font.
- 2
The regulations governing long-term care facilities were revised in October 2016. The quality-of-care regulation was reconfigured, and the requirement that facilities take necessary steps to prevent pressure sores moved from 42 C.F.R. § 483.25(c)(1) to § 483.25(b)(1). 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017). The substance of the regulation did not change, so decisions that predate the regulatory changes remain valid.
- 3
I find that the deficiencies addressed in this decision more than justify the CMP amount imposed. I therefore need not consider the remaining deficiencies cited. Perry Cnty. Nursing Ctr. v. U.S. Dep't of Health & Human Servs., 603 F. App’x 265, 271 (5th Cir. 2015) (agreeing that the regulations require ALJs to review only those findings that are material to the outcome of a case).