Cadia Rehabilitation Renaissance, DAB CR6131 (2022)

The Centers for Medicare & Medicaid Services (CMS) determined that Cadia Rehabilitation Renaissance (Petitioner or the facility) was out of substantial compliance with Medicare program participation requirements at 42 C.F.R. §§ 483.25(e)(2) and 483.25(k) (also referred to as Tags F690 and F697).  Petitioner disputes that it failed to comply with the cited regulations and also challenges the imposition of a per-instance civil monetary penalty (CMP) of $15,505 for each allegation of noncompliance, $31,010 in all.  For the reasons set forth below, I find that Petitioner was not in substantial compliance with the Medicare participation requirements found at 42 C.F.R. §§ 483.25(e)(2) and (k) (Tags F690 and F697).  I also conclude that the per-instance CMPs are reasonable.

I.     Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Millsboro, Delaware.  CMS Exhibit (Ex.) 1 at 1.  On September 6, 2018, the Delaware Department of Health and Social Services, Division of Long Term Care Residents Protection (state agency) completed an annual recertification and complaint survey of Petitioner’s facility.  Id.  Based on the survey, CMS determined that Petitioner was out of substantial compliance with Medicare participation requirements.

In a letter dated December 4, 2018, CMS notified Petitioner that it was imposing two per-instance CMPs based on the facility’s noncompliance with the regulations at 42 C.F.R. § 483.25(e) and (k), which are referred to in the statement of deficiencies as Tag F690

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and Tag F697.  Departmental Appeals Board (DAB) Electronic File (E‑File) entry 1a at 3.  Each CMP was in the amount of $15,505, totaling $31,010.00.  Id.

Petitioner timely requested a hearing and the case was assigned to me.  On January 25, 2019, I issued an Acknowledgment and Prehearing Order (Prehearing Order), establishing a briefing schedule.

On May 17, 2019, I granted Petitioner’s motion for subpoenas to compel the production of certain medical records related to two residents at Petitioner’s facility and extended Petitioner’s deadline on my own motion.  See DAB E-File entries 16, 16a, 16b.

In compliance with my Prehearing Order, CMS filed a prehearing exchange, consisting of a brief (CMS Br.) and 18 proposed exhibits, including the written declarations of three proposed witnesses (CMS Exs. 1-18).  Petitioner filed its prehearing exchange, consisting of a brief (P.Br.) and 3 proposed exhibits (P. Exs. 1-3).  Petitioner did not propose witnesses but did request to cross-examine CMS’s witnesses.

I scheduled a hearing for November 17 and 18, 2020, to permit Petitioner to cross-examine CMS’s witnesses.  However, by motion filed October 7, 2020, CMS requested to postpone the testimony of state agency surveyor Karen Linderborn (Surveyor Linderborn) for medical reasons.  I held a telephone prehearing conference on October 14, 2020, to address CMS’s motion.  During the conference, counsel for Petitioner agreed to postpone cross-examining Surveyor Linderborn and to proceed with cross-examining CMS’s two remaining witnesses.  I therefore issued an order granting CMS’s motion and shortening the hearing to a single day.

On November 17, 2020, I convened the hearing, which I conducted via video teleconference.  A transcript (Tr.) was made of the proceeding.  I presided remotely from my home office in the greater Washington, D.C. area.  Mark Yost, Esq., represented Petitioner, and appeared from Baltimore, Maryland.  Diane Howell, Assistant Regional Counsel, represented CMS, and appeared from Philadelphia, Pennsylvania.  I admitted CMS Exs. 1-18 and P. Exs. 1-3.  See Transcript (Tr.) at 3, 4, 13, 40, 58.  During the hearing, counsel for Petitioner cross-examined state agency surveyors Lynne Van Pelt and Karen Linderborn,¹ and Beryl Goldman, RN, Ph.D., CMS’s expert witness.  Following the hearing, each party submitted a post-hearing brief (CMS Posthrg. Br.; P. Posthrg. Br.).

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II.    Issues

The issues in this case are:

1. Whether Petitioner failed to comply substantially with 42 C.F.R. § 483.25(e)(1)-(3).
2. Whether Petitioner failed to comply substantially with 42 C.F.R. § 483.25(k).
3. If Petitioner did not comply substantially with Medicare participation requirements, whether the per-instance penalties imposed are reasonable.

III.   Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

IV.    Burden of Proof

CMS must make a prima facie showing that Petitioner failed to comply substantially with federal participation requirements.  If this occurs, Petitioner must prove substantial compliance by a preponderance of the evidence in order to rebut CMS’s showing and to prevail.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff’d sub nom Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d sub nom Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998).

V.    Discussion

A.     Statutory and Regulatory Framework

The Act sets forth requirements SNFs must meet to participate in the Medicare program.  The Act authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. parts 483 and 488.  A facility must maintain substantial compliance with program requirements in order to participate in Medicare.  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

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C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)) or the Secretary’s regulations at 42 C.F.R. part. 483, subpart B.  Id.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  Among other enforcement remedies, CMS may impose a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a).  At the time CMS imposed remedies against the facility, in December 2018, the range for a per-instance CMP was $2,140 to $21,393.  42 C.F.R. § 488.438(a)(2); see also 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018).

If CMS imposes a CMP based on a noncompliance determination, then the SNF may request a hearing before an administrative law judge to challenge CMS’s determination of noncompliance that led to the imposition of an enforcement remedy.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a‑7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.330(e), 488.408(g)(1), 498.3(b)(13)-(14); see also 5 U.S.C. §§ 554, 556.  A SNF may challenge CMS’s finding as to the level of noncompliance only if a successful challenge would affect the range of CMP amounts imposed on the SNF.  42 C.F.R. § 498.3(b)(14), (d)(10).  Further, where a challenge to the level of noncompliance is permitted, CMS’s determination as to the level of noncompliance must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

B.  Findings of Fact, Conclusions of Law, and Analysis

1.  Petitioner failed to comply substantially with the Medicare participation requirements at 42 C.F.R. § 483.25(e)(2) (Tag F690).

a.  I find the following facts by a preponderance of the evidence.

Resident 257 (R257).  R257 was admitted to Petitioner’s facility on August 20, 2018, following hospitalization for a stroke or CVA (cerebro-vascular accident).  CMS Ex. 10 at 1; P. Ex. 1 at 1.  On admission, the resident was 91 years old with diagnoses that included cerebral infarction, occlusion and stenosis of bilateral carotid arteries, asthma, gout, osteoarthritis, bladder-neck obstruction, dysphagia, hypertension, hyperlipidemia, dementia, and diabetes. CMS Ex. 10 at 6, 10.

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During her August 2018 hospitalization, R257 was noted to have acute urinary retention for which the hospital placed an indwelling (or Foley) catheter.²  P. Ex. 1 at 1.  Thus, the Foley catheter was present when R257 was admitted to Petitioner’s facility.  See CMS Ex. 10 at 1.  Also on admission, the resident was noted to have an elevated temperature of 99.4°F.  Id.  The following day, August 21, 2018, R257’s temperature was 100.3°F.  CMS Ex. 1 at 50.  On that same date, R257’s physician ordered “UA [urinalysis],” but Petitioner’s records indicate that the test was “not administered.”  CMS Ex. 10 at 31.  At 12:20AM on August 22, 2018, R257’s temperature was 101.8°F.  CMS Ex. 10 at 1, 43.  On August 20 and 26, 2018, nursing notes document that R257’s catheter was draining clear, dark yellow urine.  CMS Ex. 10 at 1, 2; CMS Ex. 3 at 5 (¶14).  Elevated temperatures can be a sign of infection and dark urine can be a sign of poor fluid intake.  CMS Ex. 5 at 5 (¶ 16).

On August 26, 2018, at 10:54PM, a nurse deflated, partially rearranged, and reinflated R257’s Foley catheter.  CMS Ex. 10 at 2.  Effective August 20, 2018, R257’s physician had entered an open-ended order to “[c]hange catheter and drainage bag PRN [as needed].”  Id. at 48.  There is no record of a physician order to deflate, rearrange, and reinflate the catheter.

On August 28, 2018, during the state agency survey, the surveyor observed a nurse at the nursing station holding a specimen of dark red liquid, which the nurse identified as R257’s urine.  CMS Ex. 3 at 6 (¶ 17).  Also on August 28, Petitioner’s Interdisciplinary Team (IDT) met to review plans for R257’s care.  CMS Ex. 10 at 2.  The IDT notes confirm that R257 had blood in her urine.  Id.  The IDT notes further indicate that the catheter had been flushed and, following that, R257’s urine was clear.  Id.  Finally, the IDT planned to have nursing staff consult R257’s physician to ask for approval to remove the Foley catheter to determine if R257 was able to void independently.  Id.

On August 29, 2018, R257’s physician ordered that the Foley catheter be discontinued “for voiding trial.”  Id. at 50.  Consistent with that order, a nursing note at 9:44AM documents that the Foley catheter had been discontinued during the prior shift.  Id. at 2.  Notes from that morning document that R257 had not had much to drink, had not urinated yet, and that oral fluids were encouraged.  Id.  That afternoon, facility notes indicate that a “voiding diary” was initiated.  Id.  R257 was recorded to have voided a “large” amount, however, there are no notes recording any measurement of the amount of urine R257 produced.  Id.; see also CMS Ex. 5 at 6 (¶ 26).  At 10:26PM, nursing notes document that Resident 257 was passing “yellow, mucousy urine.”  CMS Ex. 10 at 2.  The presence of mucous in the urine can be an indication of a urinary tract infection.  CMS Ex. 5 at 6 (¶ 25).

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On August 31, 2018, Resident 257’s physician noted that she appeared weaker and less involved in her physical therapy.  CMS Ex. 10 at 6.  The physician also noted staff reports that R257 had decreased food and water intake.  Id.  The physician suspected that R257’s symptoms were caused by aspiration pneumonia.  Id.  The physician ordered antibiotics, IV fluids, oxygen, and a chest X-ray.  Id. at 2, 6.The chest X-ray was obtained and the facility reported that the impression stated “no active disease seen in the chest.”  Id. at 2.  R257’s physician also ordered urinalysis, which on this occasion was obtained.  Id. at 53.  Preliminary results of the urine culture were reported on September 1, 2018, showing bacteria growth.³  Id. at 3.

On September 1, 2018, at 9:30AM, nurses’ notes document that R257 didn’t “feel right,” had abdominal discomfort, and a temperature of 100.6°F.  Id. at 2.  A bladder scan was ordered and showed 875 ml of retained urine.  Id.  Notes show that R257 was encouraged to urinate on a bedpan and, in doing so, produced around 50 ml.  Id.  The on‑call physician ordered straight catheterization to drain the bladder and discontinued IV fluids.  Id.  At 9:45AM, facility staff catheterized R257, draining 1,000 ml (1 liter) of dark cloudy urine.  Id.  R257 reported reduced abdominal pain.  Id.  R257 was given acetaminophen for fever.  Id.  Between 11:30 and 11:45AM, R257’s temperature went down to 98.4°F.  Id.  R257’s blood pressure became very low at 88/58 and her oxygen saturation was also low.  Id.  Staff notified the on-call physician of these results, as well as the preliminary urine culture results.  Id. at 2-3.  During the evening on September 1 and in the early morning hours of September 2, 2018, R257’s oxygen saturation deteriorated further and facility staff performed nebulizer treatments and increased the resident’s oxygen in accordance with the on-call physician’s orders.  Id. at 3.

On September 2, 2018, at 9:59AM, R257 stated she felt “awful.” Id. at 3.  Nursing staff noted that R257 had congested wheezing to all lung fields and administered another nebulizer treatment.  Id.  Staff also documented “edema 1-2 + generalized.”⁴  Id.  At 11:29AM R257 complained of abdominal pain and was “not providing appropriate answers to questions.”  Id.  Another bladder scan showed retention of over 600 ml.  Id.  When informed of the resident’s condition, the on-call physician ordered straight catheterization and directed the facility to “send [patient] to ER for evaluation.”  Id.  Catheterization yielded 1,000 ml dark cloudy urine.  Id.  At 11:45AM, R257 was sent to the hospital “by 911.”  Id.

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In the ER, R257 was diagnosed with a urinary tract infection.  P. Ex. 1 at 1.  The resident was admitted to the hospital with “acute encephalopathy . . . likely due to early clinical sepsis due to catheter-related urinary tract infection.”  Id.  The hospital discharge summary further notes that R257 experienced an “acute kidney injury and dehydration.”  Id.

State Agency Survey.  The state agency conducted an annual and complaint survey of Petitioner’s facility from August 27, 2018, through September 6, 2018.  CMS Ex. 1 at 1; see also CMS Ex. 3 at 3 (¶ 8).  Surveyor Karen Linderborn was the survey team coordinator and she made the observations and performed the staff interviews that are the basis for the deficiency citation involving R257.  CMS Ex. 3 at 2 (¶ 4).  Surveyor Linderborn reviewed the clinical records of R257 as reproduced in CMS Ex. 10.  CMS Ex. 3 at 4 (¶ 10).  Surveyor Linderborn reviewed the survey findings in the statement of deficiencies and testified that the findings are accurate and complete.  Id. at 3 (¶ 8).  The statement of deficiencies describes many of the entries documented in R257’s medical record consistent with what I have found above.  See CMS Ex. 1 at 50-54, 56.  I will not repeat those findings here.

The statement of deficiencies also describes interviews that Surveyor Linderborn conducted with Petitioner’s staff.⁵  Id. at 52, 54-56.  Petitioner has not challenged the accuracy of the statements.  I therefore find it more likely than not that the statement of deficiencies accurately records the content of the interviews Surveyor Linderborn conducted.

On August 29, 2018, at 2:33PM, Surveyor Linderborn interviewed one of Petitioner’s certified nursing assistants (CNAs), identified as E11.⁶  CMS Ex. 1 at 52.  When questioned, E11 confirmed that R257’s urine output was not measured, but explained that when R257 urinated in the toilet “it sounded like a large amount.”  Id.  At approximately 2:50PM, E5, a unit manager for Petitioner, stated that “monitoring intake and output was very rarely done unless the doctor specifically ordered it.”  Id.

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On September 4, 2018, at 1:15PM, Surveyor Linderborn interviewed one of Petitioner’s nurses, identified as E17.⁷   CMS Ex. 1 at 54.  In response to a question, E17 told the surveyor that R257’s catheter was readjusted on August 26, 2018, because the catheter was leaking a little.  Id.  E17 described “clean[ing] the tube down to the end, deflat[ing] the balloon[,] push[ing] [the] catheter in a little, then reinflat[ing] [the] balloon.”⁸  Id.

At 3:05PM on September 4, Surveyor Linderborn interviewed E15, a physician.  Surveyor Linderborn informed the physician that facility staff measured R257’s urine output as “small, medium[,] and large by listening to the resident urinate in the toilet.”  Id. at 54.  The physician stated that doing so was “subjective” and that urine output should be measured in milliliters.  Id.  E15 stated that, based on the discussion with Surveyor Linderborn, “I think I may change how I do things.”  Id. at 55.  Surveyor Linderborn understood E15 to be referring to measuring urine output.  Id.

In a follow-up interview with CNA E11 on September 5, 2018 at 8:38AM, E11 was unable to state how many milliliters of urine would equal “small,” “medium,” and “large” amounts.  Id.  E11 stated that it was hard to determine the amount of urine when residents use the toilet.  Id.  E11 stated that output should be documented with every void and that milliliters would be more accurate.  Id.

Surveyor Linderborn interviewed Petitioner’s Medical Director (E21) on September 5, 2018 at 11:20AM.  Id.  E2, Petitioner’s director of nursing (DON) was also present.  Id.  The Medical Director pointed out that R257 had been administered IV contrast dye during her hospitalization and also “had retention problems.”  Id. The Medical Director further stated, “I wish the hospital would have included that in their discharge

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summary.”⁹  Id.  The Medical Director went on to explain that the resident’s catheter was removed at Petitioner’s facility and the resident “may not have been emptying her bladder which could have contributed to the renal function [problem].”  Id. at 55-56.

b.  Petitioner failed to timely treat R257 for signs and symptoms of a urinary tract infection, or to provide services to prevent a urinary tract infection, which resulted in the resident being hospitalized.

As relevant here, the Medicare participation requirement at 42 C.F.R. § 483.25(e) requires:

(2) For a resident with urinary incontinence, based on the resident’s comprehensive assessment, the facility must ensure that ‒

*        *        *

(iii) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infection and to restore continence to the extent possible.

Based on the facts described in the previous section, CMS alleges Petitioner did not provide R257 with appropriate treatment to prevent a urinary tract infection and thereby failed to comply substantially with 42 C.F.R. § 483.25(e).  CMS Posthrg. Br. at 5-8.

Petitioner disputes this, arguing I should find that the hospital from which R257 was discharged likely caused an “acute kidney injury” when the hospital administered contrast dye and failed to inform the facility of this intervention.  P. Posthrg Br. at 3.

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Further, Petitioner questions whether R257 in fact developed a urinary tract infection.  See id. at 4.  However, Petitioner offered in evidence the hospital discharge summary from R257’s September 2, 2018 hospitalization.  P. Ex. 1.  The hospital discharge diagnoses included “[a]cute UTI [urinary tract infection] cystitis, catheter related, present on admission [to the hospital].”  Id.  at 2.  Further, R257’s medical records from Petitioner’s facility document that, on September 1, 2018, the preliminary urine culture results showed significant bacterial growth.  CMS Ex. 10 at 3.  I therefore find it is more likely than not that R257 developed a urinary tract infection and that she was readmitted to the hospital as a result.

Yet, even if R257 had not developed a urinary tract infection – a finding I do not make ‒ I would nevertheless conclude that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(e).  That is because Petitioner’s staff did not provide all appropriate care to prevent a urinary tract infection.  This would have put R257 at risk of developing a urinary tract infection.  A facility fails to comply substantially with Medicare participation requirements if the facility’s noncompliance has the potential for more than minimal harm.  See 42 C.F.R. § 488.301.

R257 was at risk for developing a urinary tract infection based on risk factors identified by the National Institute of Diabetes and Digestive and Kidney Diseases:  female gender, inability to empty bladder completely, and use of urinary catheter.  CMS Ex. 3 at 7 (¶ 27).  Petitioner does not dispute that these risk factors were present.  Nor does Petitioner acknowledge or explain why its staff failed to take simple steps to prevent or detect a urinary tract infection, such as carrying out an order for urinalysis, maintaining the catheter as a closed, sterile system, or accurately measuring the resident’s urinary output, once the catheter was discontinued.  I address each of these failings below.

i.     Signs and symptoms of a urinary tract infection

Petitioner asserts that R257 “never showed the appropriate signs and symptoms to suspect” a urinary tract infection (P. Posthrg. Br. at 4), but this assertion is belied by R257’s medical records.  Upon admission to Petitioner’s facility on August 20, 2018, R257 had an elevated temperature of 99.4°F.  CMS Ex. 10 at 1.  Over the course of the next few days, R257’s temperature increased to 100.3°F and 101.8°F.  Id.  CMS’s nursing expert testified that fevers can be a sign of infection.  CMS Ex. 5 at 5 (¶ 16).  Perhaps in response to R257’s elevated temperature, on August 21, 2018, R257’s physician ordered, among other things, a urinalysis.  CMS Ex. 10 at 31.  There is no record that the urinalysis was completed, however.  Id.  See also CMS Ex. 3 at 5 (¶ 15).  Surveyor Linderborn testified that had Petitioner obtained the urinalysis sooner than it did (on August 31) doctors could have diagnosed a urinary tract infection, if present, and could have prescribed antibiotics sooner.  Tr. at 51.  Petitioner did not present testimony or even argument that a urinalysis was obtained on or about August 21, 2018.  Thus,

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Petitioner failed to take steps to determine whether R257 had developed a urinary tract infection on or about August 21, 2018.

Petitioner’s staff documented that R257 displayed other signs and symptoms in addition to fever.  R257’s catheter drained clear, dark yellow urine from August 20 through 25, which can be a sign of dehydration; dark urine can also be a sign and symptom of a urinary tract infection (CMS Ex. 10 at 1-2, CMS Ex. 1 at 51).  R257 had blood in her urine on August 28, which CMS’s nursing expert opined was a sign that the resident “likely” had a urinary tract infection.  CMS Ex. 5 at 5 (¶¶ 21, 22); see also CMS Ex. 10 at 2.

Petitioner finally argues that when urinalysis suggested a urinary tract infection was present, on or about August 31-September 1, R257 was treated with antibiotics.  P. Posthrg. Br. at 4.  The fact that Petitioner eventually initiated antibiotic treatment does not prove that its earlier failure to act was appropriate or met the standard of care.

ii.     Maintaining R257’s Foley catheter

On August 26, 2018, a nurse deflated, partially rearranged, and reinflated R257’s Foley catheter.  CMS Ex. 10 at 2.  Then, on August 28, a nurse flushed R257’s catheter after observing blood in her urine.  Id.  Surveyor Linderborn testified that it was inappropriate to flush or readjust the catheter; instead, it should have been replaced, due to the risk of bacterial contamination.  Tr. at 47, 49-50.  CMS’s nursing expert testified that flushing the catheter was not an appropriate treatment to address blood in R257’s urine.  CMS Ex. 5 at 5 (¶ 22); see also CMS Ex. 15 at 5 (“Once an indwelling catheter has been inserted . . . all possible measures should be employed to maintain a closed drainage system.  If breaks in aseptic technique, disconnection, or leakage occur, use aseptic technique and sterile equipment to replace the catheter and collecting system.”) (emphasis added).

Petitioner does not contend that its staff replaced R257’s Foley catheter on either occasion.  Petitioner presented no testimony or evidence to rebut the testimony of CMS’s witnesses that the interventions to readjust and flush the catheter did not conform to the standard of care.  I therefore find it more likely than not that readjusting the catheter and flushing it without replacing it increased the risk that R257 would develop a urinary tract infection.

iii.     Urinary Retention

On August 29, 2018, R257’s Foley catheter was discontinued for a voiding trial.  CMS Ex. 10 at 2, 50.  Following removal of the catheter, Petitioner’s staff should have recorded the amount of liquids R257 drank, the amount of urine she produced, and the amount of urine left in the bladder after urination.  CMS Ex. 5 at 6 (¶ 26).  These amounts should have been measured in milliliters.  Id.  It would have been important to do so to

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ensure that R257 was not retaining urine.  Id.  Urinary retention (i.e. the inability to empty the bladder completely) is a factor that increases the risk of developing a urinary tract infection.  CMS Ex. 3 at 7 (¶ 27).  However, interviews with Petitioner’s staff revealed that staff did not measure R257’s urinary output.  CMS Ex. 1 at 52; see also CMS Ex. 10 at 2 (R257 voided a “large” amount around 4:00PM).  Thus, Petitioner did not take adequate steps to determine if R257 was retaining urine immediately after the Foley catheter was discontinued.

On August 31, Petitioner’s physicians issued new orders to start R257 on IV fluids and antibiotics.  CMS Ex. 10 at 2.  The next morning, September 1, R257 indicated she didn’t feel right and reported abdominal discomfort.  Id.  A bladder scan indicated that R257 was retaining urine.  Id.  When the resident was only able to void “roughly 50 ml,” the physician directed staff to discontinue IV fluids and perform a straight catheterization.  Id.  A nurse’s note at 9:45AM documented “1000[ml] dark cloudy urine drained via straight [catheterization].”  Id.  On September 2, R257 reported feeling “awful,” complained of abdominal discomfort, and provided inappropriate answers to questions.  Id. at 3.  Another bladder scan revealed over 600 ml of retained urine.  Id.  It is therefore apparent that R257 was retaining urine.  The physician ordered straight catheterization and directed that R257 be sent to the emergency room for evaluation.  Id.  At the hospital, R257 was diagnosed with a “catheter-related urinary tract infection.”  P. Ex. 1 at 1.

Based on the record as a whole, I do not credit Petitioner’s argument that R257 did not develop a urinary tract infection, but instead experienced a kidney injury caused by the administration of contrast dye during the resident’s previous hospitalization.  Rather, I find it is more likely than not that R257 developed a urinary tract infection either because her catheter was readjusted ‒ and not changed – thus contaminating the closed system or because her urinary retention was not adequately addressed following removal of the catheter.  It is also possible that both factors may have contributed to the resident developing the infection.

In summary, I conclude that Petitioner failed to provide R257 appropriate treatment and services to prevent a urinary tract infection as required by 42 C.F.R. § 483.25(e).  R257 experienced actual harm due to Petitioner’s noncompliance.  Accordingly, Petitioner failed to comply substantially with 42 C.F.R. § 483.25(e) (Tag F690).

2.  Petitioner failed to comply substantially with the Medicare participation requirements at 42 C.F.R. § 483.25(k) (Tag F697).

a.  I find the following facts by a preponderance of the evidence.

Resident 105 (R105).  At the time of the events that led to the deficiency citation, R105 was 87 years old and had been a long-term resident of Petitioner’s facility since 2015.  CMS Ex. 7 at 90.  R105’s medical history included dementia, cognitive impairments,

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diabetes, major depressive disorder, hypertension, and coronary artery disease.  Id. at 91.  R105 had been moved to Petitioner’s dementia unit on January 22, 2018, because of declining cognitive status.  CMS Ex. 8 at 40; see also CMS Ex. 1 at 62.  She was also placed on hospice care due to her decline.  CMS Ex. 8 at 40.  R105 scored 6 on a Brief Interview for Mental Status (BIMS) dated February 4, 2018.  CMS Ex. 7at 87.  A BIMS score of 6 indicates that R105 was severely cognitively impaired.¹⁰  R105 had a history of attempting to transfer without assistance, which had often led to falls.  See CMS Ex. 7 at 128-32; see also CMS Ex. 8.

According to the statement of deficiencies, Petitioner’s staff completed a Facility Event Report, closed April 13, 2018, describing events of April 4-5, 2018.  CMS Ex. 1 at 62; see also CMS Ex. 4 at 4 (¶¶ 13, 16).  Although CMS Ex. 8 includes a number of event reports for R105, no copy of the event report for April 4-5 is in the record.  I nevertheless find credible and unrebutted Surveyor Van Pelt’s testimony that she reviewed such a document and that the statement of deficiencies accurately reflects its content.  I therefore find it more likely than not that the statement of deficiencies accurately describes the chronology of events as reported by Petitioner’s staff.¹¹

At approximately 9:30PM on April 4, 2018, Petitioner’s staff conducted rounds and did not note that R105 showed any signs of pain.  CMS Ex. 1 at 62.  However, at or about 11:30PM, a CNA noticed that R105 yelled out in pain and held her right hip when she was changed.  Id.  The CNA described the resident’s pain as “different” from her usual complaints.  Id.  The CNA stated she reported the resident’s pain to the nurse.  Id. However, there is no documentation of any nursing intervention at that time.

At approximately 4:00AM on April 5, an LPN was called to R105’s room to assess the resident’s complaint of right hip pain.  Id. at 62-63.  The nurse noted that R105 refused to move her right leg and lay “on her left side with her knees bent almost in fetal position.”  Id. at 63.  The nurse gave R105 1000 milligrams (mg) of acetaminophen (Tylenol) per a

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physician order for acetaminophen every 8 hours as needed (PRN) for pain.¹²  CMS Ex. 1 at 63; see also CMS Ex. 7 at 12.  The LPN charted that R105’s pain level was 6 (on a 10‑point pain scale) both before and after the resident received the acetaminophen.¹³  CMS Ex. 7 at 12.  The LPN therefore assessed the medication as not effective (NE).  Id. The LPN did not notify the physician or nurse practitioner of R105’s complaints of pain, but put a note in the “Doctor Book” to have the resident assessed.  CMS Ex. 1 at 63.

At approximately 6:00AM, R105 was administered the “routine” dose of acetaminophen (two 325 mg tablets, or 650 mg total).  CMS Ex. 7at 11.  The nurse who administered the 6:00AM dose also charted that the medication was not effective, based on level 6 pain post-administration.  Id.; see also CMS Ex. 1 at 63.  At 6:35AM, staff administered the PRN dose of ibuprofen, two 200 mg tablets.  CMS Ex. 7 at 24.  Staff charted the resident’s pre-medication pain level as 6 and her post-medication pain level as 2 and described the medication as somewhat effective (SE).  Id. at 24-25; see also CMS Ex. 1 at 63.  Despite charting R105’s pain at level 2 at 6:35, at 8:45AM, a nurse documented that R105 complained of “pain all over” and that she was “unable to straighten right leg.”  CMS Ex. 7 at 8.  At or around this time, Petitioner’s staff notified the nurse practitioner, who came in to examine R105.  Id.  The nurse practitioner ordered a right hip X-ray to be done STAT.  Id.; see also CMS Ex. 1 at 64.  The X-ray was completed at 10:45AM.  CMS Ex. 7 at 7.  However, the results were not reported until 3:00PM.  Id.  The X-ray revealed that R105 had an acute intertrochanteric fracture of the right hip.  Id.; see also id. at 96.

In the meantime, although R105 received the routine dose of acetaminophen at 2:00PM, staff charted that the medication was ineffective, rating the resident’s pain at 7 before and after administration.  Id. at 11.  Consistent with this notation, at 2:44PM, Petitioner’s staff documented that R105 complained of pain when she was repositioned for skin care.  Id. at 7.

Once the X-ray results were reported, R105’s family, in consultation with the nurse practitioner, decided that they would not send the resident to the hospital for further treatment, but they would like her to be kept comfortable.  Id.  The nurse practitioner

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added an order for 5 mg of morphine every four hours routinely.¹⁴  Id.; see also id. at 28.  R105 received the first dose of morphine at 4:00PM on April 5, 2018, and received the routine dose as prescribed thereafter.  Id. at 28.  Nevertheless, R105 continued to experience pain on April 6 and 7, 2018, particularly during care.  Id. at 5-6; see also id. at 21 (resident “continue[d] to [complain of right] hip pain” at 2:28AM on April 6, 2018).  Even though R105 continued to experience pain, there was no change to her pain medication orders until April 7, 2018.

On April 7, 2018, at 4:39PM, one of Petitioner’s nurses documented that R105 was grimacing and cried out in pain when the nurse sat her up to give medications.  Id. at 5.  On April 7 at 10:15PM, the nurse practitioner ordered morphine 5 mg every 2 hours PRN (as needed) for breakthrough pain relief.  Id. at 29; see also CMS Ex. 8 at 98.  However, Petitioner’s staff did not chart any PRN doses of morphine until 9:51AM on April 8, 2018.  CMS Ex. 7 at 29.  On April 10, 2018, R105’s physician ordered a Fentanyl patch every 72 hours for pain.  Id. at 23.

R105 passed away at Petitioner’s facility on April 18, 2018.  CMS Ex. 1 at 61, CMS Ex. 7 at 106.

State Agency Survey.  Surveyor Van Pelt participated in the survey of Petitioner’s facility from September 4-6, 2018.  CMS Ex. 4 at 3 (¶ 11).  Surveyor Van Pelt conducted the record review and staff interviews concerning the care provided to R105.  Id. at 2, 4 (¶¶ 6, 12).  In her written direct testimony, Surveyor Van Pelt reiterates many of the findings in the statement of deficiencies.  Id. at 4-7 (¶¶ 15-27).  To the extent I have described these findings in the previous section, I will not repeat them here.

Surveyor Van Pelt interviewed R105’s responsible party (her daughter, P.B.) by telephone on September 5, 2018.  CMS Ex. 13 at 14.  P.B. told the surveyor that the day before R105’s hip fracture was diagnosed, R105 screamed in pain when a hospice CNA tried to bathe her.  Id.  It appears P.B. may have been describing the episode that occurred at 11:30PM.  Cf. CMS Ex. 1 at 62.  The surveyor notes state “told nurse,” but “staff was not that concerned.”  CMS Ex. 13 at 14.  Surveyor Van Pelt also reviewed documentation of an investigation conducted by another branch of the state agency to determine whether R105’s hip fracture resulted from abuse or neglect by a member of Petitioner’s staff.¹⁵

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Id. at 6-9.  That investigator also interviewed P.B. who reported that “a hospice aide noticed the pain and told staff about the pain.”  Id. at 6.

b.  Petitioner failed to provide R105 with effective pain management, thus failing to comply substantially with Tag F697.

The Medicare participation requirement for pain management requires that “[a] facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan and the resident’s goals and preferences.”  42 C.F.R. § 483.25(k).  Petitioner argues there was no deficient practice.  P. Br. at 6, P. Posthrg. Br. at 7.  Specifically, Petitioner states that, when R105 first complained about pain on April 5 at approximately 4:00 A.M., staff immediately responded by administering acetaminophen, consistent with the physician’s orders, followed by administering an additional dose of ibuprofen, which Petitioner argues resolved R105’s pain within a 2.5 hour window.  P. Br. at 5, P. Posthrg. Br. at 5-6.  I disagree.  Instead, I find Petitioner did not take adequate steps to manage R105’s pain.

First, Petitioner’s contention that R105 first complained of pain at 4:00AM on April 5, 2018, and her pain was controlled by 6:30AM is not consistent with the facts as I have found them above.  As described above, R105’s pain was ‒ or should have been – evident to Petitioner’s staff as of 11:30PM on April 4, 2018, when she cried out in pain while being changed.  See CMS Ex. 1 at 62.  Second, I disagree with Petitioner’s contention that R105’s pain was managed as of 6:30AM on April 5.

Petitioner suggests that its staff succeeded in reducing R105’s pain to “an acceptable level” on April 5 at 6:30 A.M.  P. Br. at 5, P. Posthrg. Br. at 5.  Petitioner’s argument is based on an assessment in the medication administration record documenting that R105’s pain level was “2” after she received 400 mg of ibuprofen.  See CMS Ex. 7 at 24.  Petitioner additionally relies on a pain assessment completed January 12, 2018.  P. Ex. 2.  According to that document, R105 responded that “2” was an “acceptable level of pain.”  Id. at 2.  I do not find credible that R105 was able to provide that response.  The same form indicates that R105 was non-verbal and unable to respond to a prompt to describe the quality of her pain.  Id. at 1-2.  Thus, I agree with the opinion expressed by CMS’s nursing expert, that R105 was unable to communicate her pain level and the nurses were recording their impressions of how R105 felt.  Tr. at 65.

Further, even if the pain assessment of “2” at 6:30AM on April 5 were accurate – a finding I do not make – this would not prove that R105’s pain was managed on an ongoing basis.  CMS’s expert testified that the records show that R105 was in pain whenever she was moved.  Id. at 66; see also CMS Ex. 7 at 7. A single assessment

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documenting that the resident was in less pain does not outweigh the multiple entries documenting that she was in more pain.

Contrary to Petitioner’s position, R105’s records paint a picture of an individual whose pain was not effectively controlled for over 48 hours, from 11:30PM on April 4, until at least April 7 at 10:15PM, when a nurse practitioner added an order for morphine every 2 hours as needed for breakthrough pain relief.  See CMS Ex. 7at 29; see also CMS Ex. 8 at 98.  The CNA who provided care to R105 at 11:30PM informed nursing staff that the resident was in pain; however, there is no documentation that a nurse assessed R105 until about 4:00AM on April 5.  Id. at 62-63.  At that time, the nurse administered acetaminophen, which was ineffective.  Id. at 63; see also CMS Ex. 7 at 12.  The nurse did not notify the physician or nurse practitioner to request new orders but wrote a note to have R105 assessed and to report to the next shift.  CMS Ex. 1 at 63, 66.

It was not until approximately 8:45AM on April 5 that a nurse practitioner examined R105 and ordered an X-ray.  Id. at 63-64.  By then, over eight hours had elapsed since R105 showed indications of severe pain.  Moreover, even after the nurse practitioner assessed R105 and ordered an x-ray, two more hours elapsed before the X-ray was taken and the results were not reported for four more hours.  CMS Ex. 7 at 7.  During all that time – approximately fourteen hours in all – Petitioner’s staff administered over-the-counter pain medications which were not effective in relieving R105’s pain.  See, e.g., id. (“Tylenol given for pain with no positive results” at 2:44PM); see also Tr. at 72-73 (CMS’s expert stated that, in her nursing experience, acetaminophen and ibuprofen are not appropriate for acute pain).

When the results of R105’s X-ray were reported, at around 3:00PM, it became clear that the resident had an acute fracture of her right hip.  CMS Ex. 7 at 7. At that time, the nurse practitioner added a routine order for 5 mg of morphine every four hours.  Even though the morphine was more effective than the acetaminophen and ibuprofen, R105 continued to have pain and restlessness through April 6 and 7.  CMS Ex. 1 at 64-65; see also CMS Ex. 7 at 4-6.  On April 7, the nurse practitioner gave new orders for morphine as needed every two hours for breakthrough pain and Ativan for anxiety and restlessness, which ultimately aided R105 in resting comfortably.  See CMS Ex. 7 at 4.

In summary, Petitioner did not effectively manage R105’s pain during the first several days after her injury.  Petitioner’s actions had the potential to cause more than minimal harm.  In fact, because R105’s pain was not under control, she experienced actual harm (pain) each time she was repositioned.  Accordingly, Petitioner did not comply substantially with 42 C.F.R. § 483.25(k) (Tag F697).  Because Petitioner was out of substantial compliance with two Medicare participation requirements, CMS was authorized to impose enforcement remedies.  In the following sections of this decision, I consider whether the Petitioner may challenge CMS’s finding of actual harm and whether the of per-instance CMPs imposed for Tags F690 and F697 are reasonable.

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3.  Petitioner has no right to challenge the scope and severity of the deficiencies in this case.

Petitioner argues that it may challenge CMS’s rating of the facility’s deficiencies at scope and severity “G,” which corresponds to isolated noncompliance that causes actual harm that is not immediate jeopardy.  In Petitioner’s view, CMS’s scope and severity finding is at issue “[b]ecause a successful challenge to the alleged noncompliance would affect the amount of the CMP and the nurse aid training program.”  P. Br. at 7, P. Posthrg. Br. at 7 (citing 42 C.F.R. § 498.3(b)(14)).  Petitioner’s position appears to be that its challenge to CMS’s finding of actual harm falls within the scope of the regulation because the facts in this case support only a lower scope and severity level, one where CMS would be without basis to impose a CMP at all.  P. Br. at 7, P. Posthrg. Br. at 7 (“CMS would not have issued a CMP . . . for low level citations, but [did so] for the actual harm deficiencies.”).

The regulations provide that an administrative law judge may review CMS’s scope and severity finding “only if a successful challenge . . . would affect:  (i) the range of the CMP amounts that CMS could collect . . . ; or (ii) a finding of substandard quality of care that results in the loss of approval [of a facility’s] nurse aide training program.”  42 C.F.R. § 498.3(b)(14) (emphasis added).  Petitioner’s argument misreads the regulation by treating the amount and range of the CMP as interchangeable.  The scope and severity cited, as well as other factors, may affect CMS’s selection of a CMP amount.  42 C.F.R. §§ 488.404, 488.438(f).  However, the scope and severity determination does not affect the CMP range CMS may choose when imposing a per-instance penalty.

In the case of a per-instance CMP, the regulations provide for a single penalty range without regard to the level of noncompliance.  42 C.F.R. § 488.438(a)(2).  Thus, if CMS decides to impose a per‑instance CMP, the amount selected must fall within the single range.  At the time CMS imposed remedies in December 2018, the range was $2,140 to $21,393.  42 C.F.R. § 488.438(a)(2); 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018).  There is no separate, lower range (and no zero-amount range) for CMS to choose when it is without basis to impose a CMP.  Indeed, if Petitioner successfully showed that CMS had no basis to impose a CMP at all, there would be no further scope and severity determination to review.

In summary, because there is only a single range for per-instance CMPs, the CMP amount selected by CMS after considering the various factors must fall within that single range.  Therefore, Petitioner’s challenge to the scope and severity finding of actual harm does not affect the range of CMPs that may be imposed.  See NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014); see also Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 24 (2011).  Furthermore, as I explain below, the amounts of the CMPs imposed are reasonable.

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4.  The per-instance CMPs imposed are reasonable.

I evaluate whether a CMP is reasonable by applying 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) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 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.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2)-(3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).

Besides arguing that the facility’s noncompliance, if any, did not cause actual harm, Petitioner does not argue that any particular regulatory factor supports a reduction of the CMP amounts proposed by CMS.  P. Posthrg. Br. at 7-8.  For that reason alone, I could conclude the CMP amounts are reasonable.  See Coquina Ctr., DAB No. 1860 at 32.  However, I have reviewed the regulatory factors and explain why I find that they support a conclusion that the CMP amounts are reasonable.

First, the deficiencies were serious.  As I have found above, Petitioner’s noncompliance resulted in actual harm to two residents.  R267 required hospitalization after the facility failed to treat signs and symptoms of a urinary tract infection in a timely manner.  R105 remained in pain from a hip fracture for over 48 hours due to inadequate pain management.  Second, in both instances, Petitioner was culpable (in the sense of responsible) for the deficient practices.  The record contains no evidence regarding Petitioner’s compliance history or its financial condition.

CMS imposed a $15,505 per-instance CMP for each instance of noncompliance.  The CMP amount falls in the upper third of the CMP range in effect at the time ($2,140 to $21,393).  I find that the per-instance CMP amount imposed for each deficiency is reasonable based on the factors of seriousness and culpability.

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VI. Conclusion

For the reasons discussed above, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirements at issue.  Accordingly, I conclude that CMS had a basis to impose the per-instance CMPs.  I also conclude that the CMPs imposed are reasonable.

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Endnotes