Generations at Elmwood Park, DAB CR6333 (2023)

DECISION

The case before me involves a long-term care facility’s responsibility to ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents’ choices.

Petitioner, Generations at Elmwood Park (Petitioner or the facility), is a licensed and certified skilled nursing facility (SNF) in Elmwood Park, Illinois.  The Illinois Department of Public Health (IDPH or state agency) is designated as the state survey agency for Illinois for monitoring compliance with the Centers for Medicare and Medicaid Services’ (CMS) federal nursing home rules and regulations.  On September 8, 2021, IDPH initiated a complaint survey to assess the facility’s compliance with Medicare program requirements.  Based on the survey, IDPH issued a Statement of Deficiencies (SOD) finding that the facility was not in substantial compliance with 42 C.F.R. § 483.25 at a scope and severity level of G¹.  CMS Exhibit (CMS Ex.) 1 at 1, 10; CMS Ex. 42 at 2. Specifically, the SOD documented that the facility failed to ensure that staff performed an assessment when a resident complained of foot pain; failed to follow physician orders and to ensure that urgent orders were carried out; failed to notify the physician regarding a change in condition; and failed to assess/treat arterial wounds timely.  CMS Ex. 1.  As a result, CMS imposed a per-day civil monetary penalty (CMP)

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of $980 beginning September 8, 2021 and continuing through September 23, 2021, for a total CMP of $15,680.

For the reasons set forth below, I find that the facility was not in substantial compliance with the Medicare program requirement at 42 C.F.R § 483.25 and that the penalty is reasonable.

I.    Procedural Background

On September 21, 2021, the IDPH confirmed that it completed a licensure survey at the facility on September 9, 2021.  IDPH explained that, based on its findings, it may issue licensing violations which may result in a monetary fine, conditional license, or other serious licensure penalty.  CMS Ex. 6 at 1.  On October 28, 2021, CMS notified the facility that, as a result of the September 9, 2021 survey, CMS was imposing a CMP of $980 per day for sixteen (16) days beginning September 8, 2021, and continuing through September 23, 2021, for a total of $15,680.  CMS Ex. 12.  On December 27, 2021, Petitioner filed an appeal of CMS’s determination and requested a hearing on the matter.  Request For Hearing (RFH) at 1.  On January 5, 2022, the Departmental Appeals Board of the United States Department of Health and Human Services (DAB or Board) acknowledged receipt of Petitioner’s RFH and the presiding Administrative Law Judge (ALJ)² issued a Standing Order (SO).  The Order set out deadlines for the parties to submit their pre-hearing briefs and proposed exhibits, as well as their written request and intention to cross-examine opposing party witnesses.

a.    The Parties’ Submissions

On April 5, 2022, CMS filed “Centers For Medicare & Medicaid Services’ Combined Motion for Summary Judgment and Prehearing Brief” (CMS Br.).  CMS also submitted 48 proposed exhibits (CMS Exs. 1-48), which included the written direct testimony of Lakeitha Day, R.N. (Surveyor), the individual who conducted the September 9, 2021 complaint survey.  On May 6, 2022, Petitioner filed “Generations At Elmwood Park’s Pre-Hearing Brief and Response to CMS’ Motion For Summary Judgment" (P. Br.). Additionally, Petitioner submitted nine proposed exhibits (P. Exs. 1-9).  Although Petitioner did not submit written direct testimony for any witness, Petitioner asserted that it reserves the right to question “any and all CMS witnesses at a hearing on this matter.” Generations At Elmwood Park List Of Proposed Exhibits and Witnesses (P. Proposed Exhibits and Witnesses).  On May 9, 2022, and by direction of the presiding ALJ, Attorney Advisor Taylor Isaac notified Petitioner of the requirements for requesting cross examination of opposing party witnesses.  The notification confirmed that, in accordance

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with 42 C.F.R. § 498.62, the presiding ALJ would not afford an opportunity for cross-examination absent an explicit request for cross-examination of a particular witness.  The notification gave Petitioner a deadline of May 11, 2022 to file an explicit request to cross-examine CMS’s witnesses, or else the presiding ALJ would assume that Petitioner did not intend to do so.  DAB E-File Dkt. C-22-221, Doc. No. 13.  Petitioner did not file a response or file a request to cross examine a specific CMS witness.

b.    CMS’s Motion for Summary Judgment

In conjunction with its pre-hearing brief, CMS moves for summary judgment.  CMS Br.  As noted above, CMS submitted the sworn written testimony for Surveyor Lakeitha Day, R.N.  Petitioner submitted no witnesses for sworn testimony.  As also noted above, while Petitioner was given until May 11, 2022 to file an explicit request to cross-examine CMS’s witness, Petitioner did not do so.  Accordingly, a hearing is unnecessary for the purpose of cross-examination of witnesses.  SO at 8.  Although CMS moves for summary judgment, I find that this matter may be decided on the written record, without considering whether the standards for summary judgment are met.  Accordingly, CMS’s Motion for Summary Judgement is denied as moot.

c.    Petitioner’s Objections

On May 6, 2022, Petitioner filed objections (P. Objections) to CMS Exs. 1, 32-38, 40, and 41; objecting in their entirety based on hearsay.  Petitioner’s Objections contain no citations to any statute, regulation, or case in support of its arguments.  See generally P. Objections.

CMS filed no objections to Petitioner’s proposed exhibits.

For the reasons set forth below, Petitioner’s arguments in support of its objections are without merit.  First, hearsay statements are admissible in a proceeding such as this, even if they are inadmissible under the rules of evidence applicable to court proceedings.  42 C.F.R. § 498.61.  Furthermore, it is my responsibility to fully inquire into all matters at issue and to receive into evidence documents that are relevant and material.   42 C.F.R. § 498.60(b)(1).

The Board has long recognized that hearsay may constitute substantial evidence of noncompliance if sufficient indicia of reliability are found.  Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 9 (2017); Florence Park Care Ctr., DAB No. 1931 at 10 (2004) (citing Pacific Regency Arvin, DAB No. 1823 at 14 n. 6 (2002)).

In objecting to CMS Ex. 1, the SOD, Petitioner submits that the document “contains the allegations that are being made against the Facility and is full of reports of staff and other interviews, as well as reports of medical records.”  P. Objections at 1.  The Board has,

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however, rejected similar arguments and has found that a SOD may function as both a “notice document” and as evidence of the facts asserted there.  Laurels at Forest Glenn, DAB No. 2182 (2008).  Further, the references to interviews and medical records in the SOD are also discussed and documented in the Surveyor’s seven-page sworn testimony; an exhibit that is not included with Petitioner’s objections to CMS Exs. 1, 32-38, 40 and 41.  CMS Ex. 42; P. Objections.

In objecting to CMS Exs. 32-38 as hearsay, Petitioner asserts that these documents are “interview notes that have not been transcribed word for word and do not have the hallmarks of reliability.”  P. Objections at 1.  There is no dispute that CMS Exs. 32 through 38 contain the Surveyor’s documented notes from her interviews with the facility’s nursing staff, including the interim Director of Nursing (DON), as well as the wound care physician, the wound care nurse, and the diagnostic technician who received and processed the wound care physician’s order for R1’s arterial and venous doppler testing.  As discussed further in this decision, portions of these recorded interviews deal with the facility’s level of care and the monitoring of treatment for R1.  The individuals interviewed and recorded in the Surveyor’s notes were either employees of the facility or were closely associated with the Resident’s treatment, and as such, they were available to the Petitioner for interviews to either confirm or contradict the Surveyor’s notes. Petitioner did not, however, exercise its option to present witnesses with first-hand knowledge to contradict or rebut the Surveyor’s notes in CMS Ex. 32-38, or to rebut the Surveyor’s sworn testimony, which further references these interviews.  Omni Manor Nursing Home, DAB No. 1920 at 12 (2004) (noting that although the SNF could have but chose not to present witness testimony to refute assertions set forth in the SOD and surveyor’s notes, it was sufficient for the ALJ to reject the SNF’s objection to the admissibility of the SOD and surveyor’s notes).

Furthermore, the Board has consistently held that statements of facility employees to the surveyor may be admitted in an administrative proceeding and may constitute substantive evidence for purposes of review.  See Beatrice State Developmental Ctr., DAB No. 2311 at 18 (2010); Omni Manor Nursing Home at 11.  CMS further submits that, under Federal Rule of Evidence 801(d)(2)(D), a statement is not hearsay if that statement “is offered against an opposing party and…was made by the party’s agent or employee on a matter within the scope of that relationship and while it existed.”  Centers for Medicare & Medicaid Services’ Reply to Petitioner Generation at Elmwood Park’s Prehearing Response Brief and Objections (CMS Reply Brief) at 3.  As CMS asserts, the Board has held that “there can be little doubt that responding accurately to the questions of an authorized state surveyor” is within a facility staff members’ scope of employment. Id. (citing Carehouse Convalescent Hospital, DAB No. 1799 at 30, n. 20 (2001)).

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Lastly, Petitioner objects to CMS Exs. 40 and 41³ on the basis that these documents are the Surveyor’s notes and documentation of “what she chose to document from review of records and interviews.”  P. Objections at 1-2.  Petitioner maintains that “there is no guarantee of accuracy as these interviews and documents are not transcribed word for word.”  Id.  I note that CMS Ex. 40 is a one-page worksheet in which the Surveyor lists such information as the names of the facility Administrator and the DON, as well as names of other staff associated with specific resident rooms and the description of care provided for the various facility floors.  The proposed exhibit also documents the facility census and the times that call lights were answered for various resident rooms.  It is apparent that the information documented in CMS Ex. 40 came from the facility’s own records and is easily verifiable from the facility records.  Although Petitioner raises an objection, Petitioner has submitted no evidence or sworn testimony to contradict the worksheet notes.  Furthermore, the Board has rejected a facility’s argument that a surveyor’s notes and records review do not constitute admissible evidence.  See The Windsor House, DAB No. 1942 at 25 (2004).

CMS Ex. 41 is a half-page document that sets forth the Surveyor’s observations from September 8 to September 9, 2021.  The notes include the Surveyor’s observations that the unit was clean and orderly and there was no issue with staff answering call lights in a timely manner.  The observations also document:  (1) residents are wearing masks while waiting for their lunch to be served; (2) the absence of any pressure ulcers for a particular resident; and (3) the setting for a resident’s air mattress.  The notes further include the Surveyor’s interview with a resident who stated that she did not have any issues with the facility.  In the portion of the worksheet that would document concerns, there are none noted.  Inasmuch as the document presents primarily positive observations of the facility, it is surprising that Petitioner finds the document objectionable and may have inadvertently included this proposed exhibit as objectionable.  Regardless, Petitioner has not persuasively demonstrated that CMS Ex. 41 should be excluded.

For the reasons discussed above, I overrule Petitioner’s objections to CMS Exs. 1, 32-38, 40 and 41.  Accordingly, I receive CMS Exs. 1 through 48 and Petitioner Exs. 1 through 9 in evidence.

II.    Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for SNF’s or long-term care (LTC) facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing these statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in Medicare, a LTC facility must be in “substantial compliance” with the

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participation requirements in 42 C.F.R., Part 483, subpart B.  42 C.F.R. §§ 483.1, 488.404.  A “deficiency” is a “failure to meet a participation requirement.”  Id; 42 C.F.R.  § 488.301.  A LTC facility is not in “substantial compliance” when it has one or more deficiencies that have the potential for causing more than minimal harm to residents.  Id.

The Secretary contracts with state agencies to survey LTC facilities to determine whether they are in substantial compliance with program requirements.  Act § 864 (a); 42 C.F.R. § 488.20.  CMS may impose enforcement remedies based on the survey results, including a per-day or per-instance Civil Money Penalty (CMP) on a LTC facility that is not in substantial compliance.  42 C.F.R. §§ 488.400, 488.402(b), (c), 488.406.  CMS determines the amount of a CMP based on multiple factors, which include the “seriousness” of the noncompliance.  42 C.F.R. §§ 488.404(b), 488.438(f).  “Seriousness” is a function of the noncompliance’s scope (whether it is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether it has created a “potential for harm,” resulted in “actual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R. § 488.404(b).

III.    Issues

The issues before me are:

1.   Whether the facility was in substantial compliance with 42 C.F.R. § 483.25.

2.   Whether the CMP imposed for the non-compliance is reasonable.

3.   Whether Petitioner is entitled to other relief as requested.

IV.    Findings of Fact, Conclusions of Law, and Analysis⁴

A.    Petitioner was not in substantial compliance with 42 C.F.R. § 483.25

1.    Governing Guidelines and Authority

42 C.F.R. § 483.25 documents that quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents’ choices.  Section 483.25 (b)(1)(i) specifically provides that, based on the comprehensive assessment of a resident, the facility must ensure that a resident receives care, consistent with professional standards of practice, to prevent

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pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable.  Section 483.25(b)(1)(ii) further provides that residents with pressure ulcers receive necessary treatment and service, consistent with professional standards of practice, to promote healing, prevent infection, and prevent new ulcers from developing.  Section 483.25(b)(2)(i) further provides that, to ensure that residents receive proper treatment and care to maintain mobility and good foot health, the facility must provide foot care and treatment, in accordance with professional standards of practice, including to prevent complications from the resident’s medical condition(s).

2.    The Facility’s Policy Concerning Resident Care

The facility’s policy at the time of the survey required nursing staff to notify the resident’s attending physician when there is a significant change in the resident’s physical, mental, or psychological status.  CMS Ex. 20 at 1.  The policy also provides that, except in medical emergencies, notification will be made within twenty-four (24) hours of a change occurring in the resident’s condition or status and the nurse will record in the resident’s medical record any changes⁵ in the resident’s medical condition or status.  Id.

3.    Factual Background

CMS alleges that, in August 2021, the facility failed to assess the source of Resident 1’s (R1) pain, follow facility policy to update R1’s physician on R1’s changed condition, and follow the physician’s orders concerning the timing of Doppler tests to detect a blood clot.  CMS submits that R1 developed an arterial wound on his foot and developed blood clots in both legs.  Further, CMS asserts that the blood clots required surgery, his foot wound became gangrenous, and he was hospitalized for three days.  CMS Br. at 1.

R1 was admitted to the facility in 2019.  His diagnoses included End-Stage Renal Disease (ESRD), vascular dementia with behavioral disturbance, hypertensive chronic kidney disease with Stage 5 chronic kidney disease, dependence on renal dialysis, unspecified atrial fibrillation, dysphagia, presence of cardiac pacemaker, idiopathic gout, nontraumatic intracranial hemorrhage, bradycardia, anemia, vitamin D deficiency, hyperlipidemia, major depressive disorder, and failure to thrive.  P. Ex. 1; CMS Ex. 27 at 2; CMS Ex. 28.

Because R1 was at a moderate risk for skin breakdown, certified nursing assistants (CNA’s) and nursing personnel were to report any signs of skin breakdown, including

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sore, tender, red, or broken areas.  CMS Ex. 28 at 1.  As of October 25, 2020 and continuing, the treating physician ordered weekly skin checks for R1.  CMS Ex. 25 at 3.

On August 6, 2021, R1 complained to the dialysis nurse of bilateral foot pain at a level 6/10 on the pain scale.  He was given Tylenol for the pain and the nurse noted the need to “follow up with effectiveness of pain medication.”  The Surveyor’s review of R1’s medical record and progress notes did not reflect that anyone examined R1’s foot on August 6. 2021.  CMS Ex. 26 at 9; CMS Ex. 42 at 4.  On August 11, 2021, R1 refused to go to dialysis and reported that he did not feel well and was in pain.  He reported his pain level as 100 on a scale of 1-10.  He was given pain medication.  While R1 self-assessed that the rain “messes” with his arthritis, R1’s progress notes do not reveal that there was any examination of his feet or any additional examination to determine the cause of the pain.  CMS Ex. 26 at 8.  Additionally, there is no documentation that his physician was notified of the resident’s reported pain.

On August 19, nursing progress notes reflect that an “abrasion” was discovered on R1’s left foot.  CMS Ex. 22 at 1; CMS Ex. 26 at 8.  At the request of the facility’s referring provider, the wound care physician conducted a wound care assessment and evaluation on August 19.  The wound care physician could not detect a pulse in either lower extremity and found that there was mild edema and warmth in his left foot.  Additionally, the wound care physician documented that R1 had an arterial wound of the left, medial foot with thick adherent black necrotic tissue.  CMS Ex. 21 at 1-2.   Because of the resident’s severe peripheral arterial disease, wound debridement was not indicated, and the physician recommended “Arterial/venous dopplers with abls of bilateral lower extremities.”  Id.  The arterial doppler was not performed until August 20, 2021, and the venous doppler was not performed until August 24, 2021.  CMS Ex. 23 at 1; CMS Ex. 24 at 1.  In an interview with the Surveyor, the wound care physician reported that he had expected the tests to be performed “STAT⁶ ,” the date that the tests were ordered.  CMS Ex. 37 at 1.  The wound care nurse confirmed that the bilateral dopplers were ordered due to the necrosis and to make sure there was no blockage.  She also stated that she heard and was “100% sure” the wound care physician ordered the tests to be performed STAT. CMS Ex. 35.

R1’s test results revealed a blockage, likely a deep vein thrombosis (DVT) blood clot, and he was sent to Loyola’s Gottlieb Hospital Emergency Room on August 26, 2021.  CMS Ex. 23 at 1; CMS Ex. 29 at 1.  The Surveyor testified that a DVT is “a type of blood clot that accumulates in the extremities, and that cuts off blood flow to the rest of the limb by stopping circulation to the areas below the clot.”  She testified that a DVT blood clot can cause the loss of a limb.  CMS Ex. 42 at 3.  In an August 27, 2021 hospital consultation, the consulting physician noted that R1 was mildly confused and a poor historian due to dementia.  Accordingly, most of his history was obtained by a review of

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emergency room records.  CMS Ex. 29 at 25.  R1’s hospital records reflect that he was diagnosed with DVT blood clots in both the left and right legs and gangrene in his 2nd and 3rd toes of his left foot with the presence of a foul odor.  CMS Ex. 29 at 5, 11, 13.  Gangrene is defined as necrosis due to obstruction, loss, or diminution of blood supply.  CMS Ex. 45.  R1 underwent surgery for his blood clots and remained in the hospital for three days.  Id at 60.

4.    Discussion and Analysis

The Surveyor documented that, because the facility did not give R1 adequate medical care, the facility was cited with a violation of 42 C.F.R. § 483.25, tag F684.  Specifically, the Surveyor concluded that the facility was out of substantial compliance with F684 because its staff failed to assess R1’s foot, failed to notify a physician about R1’s change in condition, failed to follow physician orders for arterial and venous doppler scans in a timely manner, and failed to follow up with physician orders.  CMS Ex. 42 at 6.

a.    Whether the facility failed to assess R1’s foot pain and whether the facility failed to notify the physician of R1’s changed condition.

Petitioner submits that the facility properly assessed R1, addressed his pain upon complaint, and provided appropriate care as necessary for his changing condition.  P. Br. at 2.  Petitioner asserts that the SOD “attempts to paint a picture that the resident’s complaint of pain on August 6th was related to the development of breaks in skin integrity identified on August 19, 2021.”  Petitioner contends that, while the SOD states R1 complained of bilateral foot pain on August 6, 2021, R1’s skin breakdown that was observed on August 19 occurred in only the left foot.  Petitioner maintains that R1’s reported pain on August 6, 2021 was properly assessed and he was given Tylenol.   Further, Petitioner contends that he went out on pass for two days with his family.  P. Br. at 5; P. Ex. 2.

Petitioner also asserts that, while R1 refused to go to dialysis on August 11, 2021 because he did not feel well, there was no indication that he did so because of pain related to his foot.  Petitioner asserts that, because R1 also suffered from osteoarthritis and gout, there is no evidence that his refusal to go to dialysis was an indication of anything other than these conditions. P. Ex. 3, 4, and 5; P. Br. at 5-6.  Additionally, Petitioner points out that there is no evidence that the resident had any areas of breakdown prior to August 19, 2021.  Petitioner maintains that, when the nurse noted the area of breakdown, it was reported to the wound care team and the wound care physician assessed the resident and recommended treatment on that same day.  P. Ex. 6; P. Br. at 6.

I do not find Petitioner’s arguments persuasive or supported by the record evidence.  The DON confirmed that skin assessments are usually done on shower days after the CNAs

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complete the shower or bath and the nurse is expected to follow-up with a head-to-toe assessment.  CMS Ex. 1 at 5.  The surveyor testified, without contradiction, that a review of R1’s medical record reflected no skin assessments from August 6 until August 19, 2021.  CMS Ex. 42 at 5.  Additionally, R 1’s nurse could not recall if there was a skin assessment on R1’s foot.  CMS Ex. 1 at 3.  When asked why there were no skin assessments done on R1’s feet from the time he first complained of pain on August 6, 2021, to August 19, 2021, the nurse replied, “I don’t know.”  Id.

The wound care physician confirmed that the arterial doppler showed mild-to-moderate blockage, which meant that R1’s foot was getting some type of blood circulation, but not enough.  The physician further explained that mild to moderate arterial blockage begins with a small discoloration on the skin and then progresses to eschar.  With venous blockage, there is swelling and complaints of pain.  The physician confirmed that signs of blockage would have been noticeable, and the facility should have seen it, prior to August 19.  If R1 was having pain, there should have been a full assessment of his feet to make sure there was no swelling or wounds.  The wound care physician opined that the blockage had to be severe for it to become necrotic overnight.  CMS Ex. 1 at 4.

When R1 complained of pain on both August 6, 2021, and again on August 11, 2021, he was given pain medication, however there is no documentation that either a skin assessment or an assessment of R1’s pain was performed.  CMS Ex. 26 at 9; CMS Ex. 36.  There is no record that the staff even looked for the source of his pain.  Apparently, on August 11, 2021, the staff simply accepted R1’s self-diagnosis of the rain’s effect on his arthritis.  CMS Ex. 26 at 8.  Despite the treating physician’s order that R1 receive weekly skin checks and the facility’s procedures for CNAs and nursing staff to check residents’ skin in conjunction with resident showers, there is no record evidence that any staff member checked or assessed R1’s feet for 13 days following his first report of foot pain.

Petitioner takes issue with the surveyor’s assessment that the facility failed to notify the physician of a change in condition.  Specifically, Petitioner asserts that there was no evidence to support that the resident had any areas of breakdown prior to August 19, 2021, when the nurse noted the area of breakdown and then promptly reported the breakdown to the wound care team.  P. Br. at 6.  Petitioner is correct that that the breakdown was reported to the wound care physician upon the nurse’s discovery of the skin breakdown on August 19, 2021.  However, Petitioner submits no evidence to show that R1’s reported foot pain on August 6, 2021 and August 11, 2021 were reported to the physician.

b.    Whether the facility failed to follow the physician’s orders for scheduling the venous and arterial doppler procedures.

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When the wound care physician discovered the necrotic tissue on R1’s left foot on August 19, 2021, the physician ordered arterial/venous doppler tests on R1’s lower extremities.  The arterial doppler test would reveal whether blood was flowing to the extremity and the venous doppler would show whether the blood was moving away from the extremities back to the heart.  CMS Ex. 37 at 1.  The physician also told the Surveyor that he was unaware that the diagnostic testing was not done on the day of the order and he expected to have been called if not performed.  CMS Ex. 37.  The wound care nurse accompanying the wound care physician recalled hearing the physician order the venous and arterial dopplers to be performed STAT.  CMS Ex. 1 at 2.

Petitioner further argues that, contrary to the SOD’s analysis, there is no evidence that the wound care physician ordered the venous and arterial doppler to be done STAT.  Petitioner points out that neither the wound care physician’s notes (P. Ex. 6), the nurse’s notes (P. Ex. 7), nor the Doppler order (P. Ex. 8) indicate that the arterial and venous dopplers were ordered STAT.  Additionally, Petitioner points out that the wound care physician’s plan of care for treatments lists the Dopplers as “recommendation.”  P. Br. at 6.

I note that the order for the bilateral venous and arterial doppler tests were ordered via Fax at 2:53 PM on August 19.  P. Ex. 8.  At 2:59 PM on August 19, the nurse called the diagnostic center and verified that R1 was scheduled to have the arterial doppler procedure on August 20, 2021, and the venous doppler procedure on August 21, 2021.  P. Ex. 7.  The diagnostic representative told the surveyor in a September 8, 2021 interview that, while the Diagnostic Center had the order for both the arterial doppler and the venous doppler, Medicare guidelines would not approve the procedures to be done on the same day.  Accordingly, the arterial doppler procedure was performed on August 20, 2021, and the venous doppler scheduled for August 21, 2021.  The diagnostic representative confirmed that the Diagnostic Center did not conduct the venous doppler on August 21, 2021, as originally scheduled and the procedure was not performed until August 24, 2021.  The diagnostic representative could not, however, explain why there had been the delay.  CMS Ex. 1 at 3.

The facility’s DON told the Surveyor on September 9, 2021 that the diagnostic facility does not do STAT procedures and a resident must be sent to the Emergency Room in the alternative.  The DON also stated that if the procedure was not performed, the nurse should inform the physician that the test had not been performed and get a new order if needed.  The DON also explained that the nurse should call the diagnostic center to find out when and at what time the test would be performed had the test not been performed on the date that it was ordered.  CMS Ex. 1 at 5; P. Ex. 9.  Petitioner contends that, when the venous doppler did not occur as scheduled on August 21, 2021, the staff followed up and the doppler was done on August 24, 2021.  The two-page document identified as P. Ex. 9 reflects that, at 3:29 pm on August 24, 2021, the nurse contacted the diagnostic center to follow-up concerning the venous doppler procedure and was told that “someone was still scheduled to arrive” that day.  The progress notes in P. Ex. 9 do not include any

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notations for August 21, 22, or 23 to indicate that the facility made any inquiry of the diagnostic center to determine why there was a delay between August 21 and August 24.  P. Ex. 9 at 1-2.

While the wound care physician and the wound care nurse may have believed that the arterial and venous doppler procedures would be done immediately, the records do not contain a notation in support of that immediacy.  The DON confirmed that the diagnostic center does not perform such tests STAT and the facility nurse contacted the diagnostic center and confirmed that the procedures were scheduled for August 20, 2021 and August 21, 2021.  Immediately following the wound care physician’s order, the facility contacted the diagnostic facility to confirm the dates of the procedures.  Thus, Petitioner is correct that the facility initially took steps to carry out the wound care physician’s order for the doppler procedures.  However, when the diagnostic center did not perform the venous doppler procedure as scheduled for August 21, there is no record to show that the facility did anything for three days to determine why the procedure was not performed or to activate the procedure.  Furthermore, there is no evidence that the facility notified the wound care physician in the interim to let him know that there had been a delay.

B.    The CMPs imposed are reasonable

In appealing a determination of noncompliance, a SNF may challenge the reasonableness of the amount of any CMP imposed.  Crawford Healthcare & Rehab., DAB No. 2738 at 2 (2016).  In deciding whether a CMP is reasonable, I may consider only the factors specified in 42 C.F.R. § 488.483(f).  Those factors include:  (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 must 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 considering the above 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 (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1683 at 8 (2021).

In this case, CMS imposed a $980 per-day penalty for 16 days; the date of the end of the survey, September 9, 2021, until September 23, 2021, the day before the facility returned to substantial compliance with Medicare regulations, per its own Plan of Correction.

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CMS Ex. 1 at 1-3; CMS Ex. 12 at 2; CMS Br. at 16.  CMS imposed a total CMP of $15,680.00.

CMS argues that the $15,680.00 CMP is reasonable and that the facility’s failures in quality-of-care standards allowed R1’s arterial wound to progress to gangrene.  Further, CMS asserts that the failures in quality-of-care standards also allowed R1 to develop multiple blood clots, which could have been deadly if a clot had broken off and traveled to the lungs.  CMS Br. at 15; CMS Ex. 29; CMS Ex. 37 at 1; CMS Ex. 45 at 3; CMS Ex. 46 at 3.  Additionally, CMS submits that the facility’s errors were unacceptable given its staff’s failure to follow basic tenets in healthcare, including failures to follow physician’s orders and a resident’s plan of care, as well as the facility’s own policy to inform physicians of changes in patient status in a timely manner.  Citing a previous DAB case (DAB No. C-21-888), CMS also maintains that the facility has been cited on 22 prior occasions during the two years preceding the September 9, 2021 survey.

Petitioner does not address any of the statutory factors that must be considered to determine the reasonableness of a CMP and does not dispute the history of prior citations as CMS asserts.  Instead, Petitioner asserts that the CMP is unreasonable because it contends that it was not out of compliance with Medicare regulations.  Accordingly, as Petitioner asserts, because the facility was “in compliance,” the CMP was not appropriate.  P. Br. at 7.  As discussed above, I find that the facility was not in substantial compliance.  On August 6, 2021, and on August 11, 2021, R1 reported foot pain.   Although he was given pain medications to relieve the pain, there is no evidence that the facility notified his physician of a change in his condition.  There is, in fact, no evidence that any staff member performed a skin assessment or any assessment to determine the cause of his reported pain.  It was not until August 19, 2021 that the arterial wound on R1’s left third toe was discovered and the wound care physician concluded that the wound had necrotic tissue.  CMS Ex. 22 at 1; CMS Ex. 37 at 1.  Within six days of the discovery of the arterial wound, R1 was hospitalized where he was diagnosed with gangrene and ultimately underwent surgery for his blood clots.  The facility’s failure to follow its own policy, which would have resulted in R1’s skin assessment and a report of R1’s changed condition to the physician, is quite serious and supports the imposition imposed by CMS.

C.    Petitioner’s appeal is limited to CMS’ Initial Determination

In its December 27, 2021 RFH, Petitioner requests a hearing on any penalty that arises from the IDPH survey.  In not only contesting the factual and the legal basis for the imposition of the sanctions, Petitioner contests IDPH’s Discretionary Denial of Payment for New Admissions (DDPNA), the impact to the facility’s 5 Star Quality Rating, and the posting of the deficiencies to CMS’ Nursing Home Compare website.  Additionally, Petitioner contests the scope/severity level of the imposed deficiencies and requests that, until a final order is issued in this matter by the ALJ, CMS refrain from using the

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disputed citations proposed to calculate the facility’s 5 Star Quality Rating on CMS’ Nursing Home Compare website.  RFH at 1-2.

The hearing rights of a long-term care facility are established by federal regulations at 42 C.F.R. Part 498.  While a provider is entitled to further review of CMS’s initial determination, administrative actions that do not constitute initial determinations are not subject to appeal.  42 C.F.R. § 498.3(d).  A finding of noncompliance that results in the imposition of a remedy specified in 42 C.F.R § 488.406 is an initial determination for which a facility may request a hearing.  42 C.F.R. § 498.4(b)(13).  Unless the finding of noncompliance results in the actual imposition of a specific remedy, the finding is not an initial determination.  42 C.F.R. § 498.3(d)(10)(ii).

In its notice of October 28, 2021, CMS confirmed that, because it found the facility to be in substantial compliance as of September 24, 2021, neither the DDPNA nor the mandatory termination went into effect.  Accordingly, CMS is seeking only the total CMP of $15,680.00.   CMS Ex. 12.

The Board has held that it is the remedy, and not the citation of a deficiency, that triggers the right to hearing.  Schowalter Villa, DAB No. 1688 at 1 (1999); Arcadia, Acres, Inc., DAB No. 1607 (1997).  Inasmuch as termination and the DDPNA are no longer an issue or sought as a remedy, the Petitioner has no right to a hearing on those issues and thus the matter is not properly before me.  See Fountain Lake Health & Rehab., Inc. DAB No. 1985 at 6 (2005).

Petitioner’s remaining request for other relief relates to its Five-Star Rating.  Petitioner requests that “until final order is issued in this matter by a Civil Remedies Division ALJ, CMS refrain from using the disputed citations proposed to calculate the Facility’s 5 Star Quality Rating on CMS’ Nursing Home Compare website.”   Petitioner maintains that such calculation severely curtails the facility’s ability to do business and to continuously improve the life of the residents living at the facility.  RFH at 1.

The Board has found that “claimed collateral consequences” of “survey noncompliance findings” such as the citations have on a facility Five-Star Rating “do not rise to the level of a constitutionally protected interest.”  Generations at Regency Center, DAB No. 2950 at 7 (2019); see also San Fernando Post Acute Hosp., DAB No. 2942 at 15 (2012).  Citing its earlier ruling in San Fernando Post Acute Hosp., the Board in Generations reaffirmed that “the potential harm to a facility’s reputation or financial status that may flow from the publication of deficiency findings does not trigger appeal rights under the Act or regulation.” Generations at Regency Ctr. at 7.  Thus, neither the posting of the disputed citations nor the calculation of the Petitioner’s 5 Star Quality Rating based on the citations are appealable matters and are not appropriately before me.

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D.    Conclusion

Thus, beginning with the failure to assess the reason for R1’s pain on August 6, 2021, and continuing until the facility finally contacted the diagnostic center on August 24 to determine the status of a test that had been scheduled five days earlier and yet not performed as scheduled,  the facility failed to ensure that R1 received treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.  Accordingly, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 and Petitioner’s noncompliance had the potential for more than minimal harm.  I also find that the CMP total amount of $15,680.00 is reasonable.

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Endnotes

¹  Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level are designated by letters A through L.  A severity level of “G” indicates a deficiency for an isolated incident that causes actual harm but not immediate jeopardy to a resident.  State Operations Manual, chap. 7, § 7400.3.1 (Nov. 16, 2018).

²  The case was initially assigned to a different ALJ and was later transferred to the undersigned.

³  In its Reply Brief, CMS addresses Petitioner’s objections to CMS Exs. 41 and 42.   CMS Reply Br. at 5-6.

⁴   My findings of fact and conclusions of law appear as headings in bold italic type.

⁵  The policy submitted as CMS Ex. 20 includes an apparent typographical error and notes that “any chances” will be recorded in the resident’s medical record.  CMS Ex. 20 at 1.

⁶  I take administrative notice that STAT is commonly used to indicate without delay or immediately.