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                              College Park Rehabilitation and Care Center, DAB CR5972 (2021)
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College Park Rehabilitation and Care Center, DAB CR5972 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





College Park Rehabilitation and Care Center
(CCN: 676212),
Petitioner,

v.

Centers for Medicare & Medicaid Services.

Respondent.
Docket No. C-18-1052Decision No. CR5972October 27, 2021

        
              
    

      DECISION

The Centers for Medicare and Medicaid Services (CMS) moved for summary judgment, alleging that Petitioner, College Park Rehabilitation and Care Center, was not in substantial compliance with Medicare program participation requirements from March 6, 2018 through April 11, 2018; that its deficiencies posed immediate jeopardy to resident health and safety; and that the civil money penalties (CMPs) imposed for the noncompliance were reasonable.  As explained below, I find no genuine dispute of material fact in this case and grant CMS’s motion.

I. Background

Petitioner is a skilled nursing facility (SNF) located in Texas that participates in the Medicare program.  On April 11, 2018, the Texas Health and Human Services Department completed a survey of the facility.  Based on the survey findings, CMS concluded that Petitioner was not in substantial compliance with five Medicare requirements:

42 C.F.R. § 483.12(a)(1) (abuse and neglect) (F600);Page 2

42 C.F.R. § 483.25 (quality of care, professional standards of care) (F684);
	42 C.F.R. § 483.12(c)(2)-(4) (investigate allegation of abuse or neglect) (F610);
	42 C.F.R. § 483.12(b)(1)-(3) (develop and implement policies preventing neglect) (F607); and
	42 C.F.R. § 483.70 (administration) (F835).CMS further determined that each deficiency posed immediate jeopardy to resident health and safety from March 6, 2018 through March 8, 2018, and that, after the immediate jeopardy conditions abated, the facility remained out of compliance at a non‐immediate jeopardy level from March 9, 2018, through April 11, 2018.  CMS imposed the following per day CMPs based on the noncompliance: $12,004 per day from March 6-8, 2018, and $505 per day from March 9-April 11, 2018, for a total CMP of $53,182.

Petitioner timely requested a hearing before an administrative law judge to challenge CMS’s determinations.  Both parties filed their prehearing exchanges including prehearing briefs (CMS Br.; P. Br.) and proposed exhibits.  CMS moved for summary judgment (CMS Mot.) and Petitioner opposed (P. Resp.).  This case was initially assigned to Judge Carolyn Hughes and was re-assigned to me on September 2, 2020.

CMS proposed 20 exhibits (CMS Exs. 1-20) while Petitioner proposed 19 (P. Exs. 1-11, 13-20).  Petitioner raised multiple objections to CMS’s exhibits.  For the most part, the objections address the weight I should give the evidence, not its admissibility.  Based on my review, the proposed exhibits are relevant and material, and therefore may be admitted.  42 C.F.R. § 498.60(b).  More specifically:

Petitioner objects to multiple exhibits, including CMS Ex. 1 (CMS notice letters), CMS Ex. 2 (statement of deficiencies), and CMS Ex. 17 (surveyor notes), citing various federal rules of evidence.  The federal rules of evidence do not apply in this forum and, in any case, those objections go to the weight I should give the evidence, not its admissibility.  42 C.F.R. § 498.61.
	Petitioner also objects to portions of CMS Exs. 2 and 18 (surveyor declaration) on grounds that they contain legal conclusions.  If conclusions are not supported by underlying evidence, I will reject them.  To the extent Petitioner objects to the testimony as improper opinion testimony, I will disregard any testimony that purports to opine on the ultimate legal issues.Page 3

Petitioner also objects to multiple exhibits (or portions thereof) as irrelevant.  I overrule those objections:  CMS Ex. 14 is a disciplinary notice for Brenda Balderson, RN, that is related to the underlying incident at issue; CMS Ex. 16 is a report of the facility’s profile and includes information relevant to the facility’s compliance history; CMS Ex. 17 contains the surveyor notes, which include evidence related to the resident at issue (Resident 1 or R1) and the underlying incident; and CMS Ex. 20 contains demographics of the facility’s staff, which is at least minimally relevant, but also identifies which staff members were registered nurses and which were not, which is relevant to the issues surrounding the supervision of Nurse Balderson’s care.
	CMS Exs. 4-5 contain orders from the Texas Board of Nursing for Nurse Balderson and CMS Ex. 19 is a “Notification of Employment” signed by a facility official who agreed to notify the state nursing board regarding a resignation or termination by Nurse Balderson.  Petitioner objects on grounds of relevance and on the basis that Petitioner was not a party to the nursing board orders.  As explained further below, even if Petitioner was not a party to the nursing board orders, the orders and the “Notification of Employment” agreement are relevant to the issues surrounding the facility’s administration and operation in compliance with state laws.
	CMS Ex. 18 is Surveyor Katelyn Brown’s declaration.  Petitioner objects that there “may be an issue of authenticity” because the first page does not indicate who is executing the declaration.  This objection appears to be based on the fact that the surveyor’s name appears to be partially erased from the document’s title.  But the footer on each page of the declaration, including the first, clearly indicates that the pages are all part of the “Declaration of Katelyn Brown.”  Petitioner also complains that the surveyor misstates certain evidence and that she is unqualified to opine on matters such as the cause of a resident’s hospitalization or death.  These objections go to the weight I should assign such testimony.I overrule Petitioner’s objections and admit CMS Exs. 1-20.  In the absence of objections, I admit P. Exs. 1-11, 13-20.

II. Authorities

The Social Security Act (Act) sets forth requirements for SNFs participating in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, a SNF must maintain substantial compliance with

Page 4

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.

III. Issues

The general issues to be resolved are whether, as a matter of law, Petitioner’s failures put the facility out of substantial compliance with Medicare program requirements and, if so, whether the immediate jeopardy determinations were clearly erroneous and whether the penalties imposed are reasonable.

IV. Summary Judgment

Summary judgment is appropriate if a case presents no genuine issue of material fact and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing & Rehab.*, DAB No. 2539 at 3 (2013) (citing *Celotex Corp. v. Catrett*, 477 U.S. 317, 322‐25 (1986)); *Ill. Knights Templar Home*, DAB No. 2274 at 3-4 (2009), and cases cited therein.  The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  *Livingston Care Ctr. v. Dep’t of Health & Human Servs.,*388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex Corp. v. Catrett*, 477 U.S. at 322).

To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,*475 U.S. 574, 586 n.11 (1986); *Vandalia Park,*DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.,*DAB No. 1918 (2004); *Crestview Parke Care Ctr*., DAB No. 1836 at 5 (2002).  General denials do not satisfy a party’s burden to identify *specific* evidence demonstrating a material fact is in dispute.  *Shah v. Azar*, 920 F.3d 987, 995 (5th Cir. 2019); *Forsyth v. Barr*, 19 F.3d 1527, 1533 (5th Cir. 1994); *Pearsall Nursing & Rehab.*, DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner “refers broadly to ‘the evidence presented in [its] response’” but “identifies no specific evidence relevant to the material facts.”); *Ill. Knights Templar*, DAB No. 2274 at 4 (finding that the non-moving party must furnish admissible evidence of a dispute concerning a material fact); *Livingston Care Ctr*., DAB No. 1871 at 5 (2003),*aff’d, Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs.,*388 F.3d 168 (6th Cir. 2004).  The non-moving party must also show more than “some metaphysical doubt as to the material facts.”  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6 (2015), *aff’d, W. Tex. LTC Partners, Inc. v. U.S. Dep’t. of Health & Human Servs.*, 843 F.3d 1043 (5th Cir. 2016); *1866ICPayday.com L.L.C.*, DAB No. 2289 at 3 (2009) (quoting *Matsushita Elec. Indus. Co.*, 475 U.S. at 587).

Page 5

In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non‐moving party.  *Brightview Care Ctr.*, DAB No. 2132 at 2, 9 (2007); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.,*DAB No. 1943 at 8 (2004); *see also Brightview*, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non‐moving party’s legal conclusions.  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6‐7, 14-15; *cf. Guardian Health Care Ctr.*, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”); *see Green Valley Health Care and Rehab. Ctr.*, DAB No. 2947 at 8 (2019) (quoting*Johnson v. Perez*, 823 F.3d 701, 705 (D.C. Cir. 2016)).

**Summary judgment applied to administrative review in Medicare cases**.

It is well established that an administrative law judge is empowered to decide a case on a motion for summary judgment, *without an evidentiary hearing*.  *Shah v. Azar*, 920 F.3d 987, 996 (5th Cir. 2019) (citing*Cedar Lake Nursing Home v. U.S. Dep’t of Health and Human Servs.*, 619 F.3d 453, 457 (5th Cir. 2010)); *see Fal-Meridian, Inc. v. U.S. Dep’t of Health and Human Servs.*, 604 F.3d 445 (7th Cir. 2010).

As explained by Judge Posner of the Seventh Circuit Court of Appeals:  “All it means for a decision to be based on a grant of summary judgment is that there are *no issues that would benefit from being resolved in an evidentiary hearing*.”  *Fal-Meridian*, 604 F.3d at 449 (emphasis added).  There, because the petitioner/nursing home did not tender evidence that, if believed, would show its substantial compliance, the Seventh Circuit sustained an ALJ’s granting summary judgment in CMS’s favor.  *Id.* at 451.

Here, as discussed below, Petitioner’s evidence does not create a genuine dispute of any material fact.  Many of Petitioner’s arguments, moreover, center not on what the facts are, but rather the legal significance of those facts.  I therefore grant CMS’s motion for summary judgment.

V. Discussion

The facts in this case mainly concern the facility’s response to finding an unresponsive resident who had low blood sugar and other symptoms.  There is no dispute that the resident at issue, R1, was admitted to College Park on March 6, 2018, with diagnoses of Diabetes Mellitus type 2, urinary tract infection, Parkinson’s disease, and hypertension.  CMS Ex. 7 at 1.  On March 7, the day after she was admitted, R1 was observed around 10:00 p.m. to be alert and talking in her room with her family present.  CMS Ex. 2 at 8;

Page 6

CMS Ex. 17 at 20.  R1’s family eventually departed around midnight.  CMS Ex. 2 at 8.  Later that shift and into the early morning hours of March 8, Nicole Martin, CNA observed that R1 was “not right” and attempted to notify Brenda Balderson, RN.  CMS Ex. 2 at 8; CMS Ex. 17 at 20.

There is a dispute as to when exactly Nurse Balderson was alerted to R1’s condition.  P. Resp. at 8 n.2; CMS Ex. 17 at 20; CMS Ex. 18 at 4.  For purposes of ruling on CMS’s motion for summary judgment, however, I will accept Nurse Balderson’s testimony that she was first notified “at approximately 3:10 a.m.” that R1 “didn’t ‘look right.’”  P. Ex. 14 at 1; *see also* P. Ex. 4 at 1.

Nurse Balderson further testified that she “immediately went down to [R1’s] room” to complete a set of vital signs and an assessment:

I called out her [R1’s] name, did the sternal rub, and that is when I noticed that her skin was cool and clammy.  I suspected that her blood sugar was down.  After making sure the bedrails were in place, I left the room to get a glucometer.  When I returned a few minutes later, I tested [R1’s] blood sugar level.  It was 21.  I left the room, again, to get Glucagon (for which I had a standing order) from the medication room.  I returned to the resident’s room and administered 1 mg Glucagon at 3:14 a.m.

P. Ex. 14 at 1-2; *see also* P. Ex. 4 at 1; CMS Ex. 11 at 17 (showing Glucagon administered at 3:15 a.m.).  Consistent with this testimony, Nurse Balderson entered the following nursing note at 3:14 a.m.:

Resident became unresponsive to stimuli.  Skin was cool to touch and calmy [sic].  Had frothy secretions coming out of her mouth.  Head was repositioned to prevent aspiration.  [Finger-stick blood sugar] taken and noted to be 21.  Glucagen [sic] 1mg given [intramuscular].  Vital signs 95.8‐79-20-158/95 noted.  Continue to monitor closely.

CMS Ex. 9 at 7.  The standing order for Glucagon referenced in Nurse Balderson’s testimony and her nursing note called for staff to “Inject 1 mg intramuscularly as needed for Low Blood Sugar if Blood Sugar is less than 60 and Resident is unresponsive.”1
  CMS Ex. 11 at 17; *see also* P. Ex. 6.

Page 7

As for the events following the administration of the Glucagon, Nurse Balderson’s testimony and her nursing notes, which are generally consistent with each other, recount the following timeline:

**3:15 a.m.**(approximately):  Nurse Balderson administered Glucagon to R1
	**3:25 a.m.:**  Nurse Balderson rechecked R1’s blood sugar, which showed “an improved reading of 40.”
	**3:35 a.m.**:  Nurse Balderson left the room “briefly” to care for another resident.
	**3:45 a.m.**:  Nurse Balderson returned to R1’s room and rechecked R1’s blood sugar, which increased to 59.
	**3:50 a.m**.:  Nurse Balderson attempted to contact R1’s physician for the first time and left a message on his voicemail.
	**3:55 a.m.**:  Nurse Balderson contacted emergency medical services (EMS).P. Ex. 14 at 2; CMS Ex. 9 at 7.  A nursing note adds the following observations:

Resident remained unresponsive to stimuli, eyes appeared to be rolled back after being given Glucagon at 0315. . . .  Was unable to rouse to sternum rub.  Lifecare notified at 0355. . . .  Resident finally arouse[d] after IV infused but wasn’t back to baseline.  Resident was making loud noises with no words.  Resident was transferred to stretcher and taken to ambulance at 0430 to be transported over to MCW ER.  Have not been able to contact spouse due to no number found at this time.

CMS Ex. 9 at 7.  After several days in the hospital, R1 remained mostly unresponsive and then was discharged to hospice care where she eventually passed away a few days later.

Page 8

CMS Ex. 13 at 30-31; *see, e.g.*, CMS Ex. 2 at 3 (resident expired on March 14, 2018, after being taken off life support); CMS Ex. 18 at 2.

At the time of the incident with R1, Nurse Balderson’s nursing license was on probation with certain stipulations placed on her license.  Based on a prior incident, the Texas Board of Nursing found that Nurse Balderson failed to initiate cardiopulmonary resuscitation to a resident and went to check his code status instead.  CMS Ex. 4 at 2.  The Texas Board further found that Nurse Balderson’s actions during that prior incident “resulted in an unnecessary delay in care, and was likely to injure the resident, including possible demise from the lack of timely interventions and appropriate nursing care.”  CMS Ex. 4 at 2.  In an agreed order, effective July 20, 2017, the Texas Board stayed the suspension of Nurse Balderson’s nursing license, but placed it on probation for a minimum of two years and until Nurse Balderson fulfilled certain requirements.  CMS Ex. 4 at 3-9.  The agreed order further provided that Nurse Balderson “SHALL be supervised by a Registered Nurse, if licensed as a Registered Nurse . . . who is on the premises” and that “[t]he supervising nurse is not required to be on the same unit or ward as [Nurse Balderson], but should be on the facility grounds and readily available to provide assistance and intervention if necessary.”  CMS Ex. 4 at 3, 6.

There is no dispute that College Park was aware of the stipulations placed on Nurse Balderson’s nursing license, including the indirect supervision requirement.  College Park’s Corporate Director of Clinical Services signed a Notification of Employment form, acknowledging:  “I have received a complete copy of the Order of the Board and am aware of the stipulations placed on [Nurse Balderson’s] license by the Texas Board of Nursing.  I agree to notify the Board’s office and provide information to the Board regarding this nurse’s resignation or termination.”  CMS Ex. 19 at 1 (emphasis omitted).  Nevertheless, it is undisputed that no other registered nurse was on site with Nurse Balderson during multiple night shifts, including the night of the incident with R1.  CMS Ex. 18 at 8; CMS Ex. 6 at 20-21 (staffing for night shifts on March 1 and 7, 2018); CMS Ex. 20 (staff roster); CMS Ex. 2 at 61 (The facility’s Administrator stating in an interview with the surveyor that “because of their mistake, [Nurse Balderson] worked over 20 night shifts since December without another RN supervising her according to her probation terms.”).

**Failure to ensure residents are free from neglect and failure to comply with quality of care requirement:** **42 C.F.R. §§ 483.12, 483.25**

A SNF must ensure that its residents are free from abuse and neglect.  42 C.F.R. § 483.12.  “Neglect” means failure by a facility or its staff to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.  42 C.F.R. § 488.301.

Page 9

There is no dispute that, at around 10:00 p.m. on March 7, 2018, R1 was alert and talking in her room, and that, by the early morning hours, around 3:10 a.m., Nurse Balderson assessed R1 and found that she was unresponsive to stimuli, that her skin was cool and clammy, that she had frothy secretions coming out of her mouth, and that her blood sugar level was 21.  CMS Ex. 9 at 7; P. Ex. 14 at 1-2.  Nurse Balderson’s observations support that there was  a “significant” change in R1’s condition, which the facility defined as a decline or improvement in a resident’s status that will not normally resolve itself without intervention by staff or by implementing standard disease-related clinical interventions (is not “self-limiting”); impacts more than one area of the resident’s health status; requires interdisciplinary review and/or revision to the care plan; and ultimately is based on the judgment of the clinical staff and the guidelines outlined in the Resident Assessment Instrument and 42 C.F.R. § 483.20(b)(ii).  CMS Ex. 15 at 1.

Indeed, R1’s critically low blood sugar of 21, alone, represented a significant change in condition.  *See also* P. Ex. 17 at 11 (Petitioner’s expert acknowledging that R1 “experienced an episode of critically low blood sugar.”)  As the surveyor testified, blood sugar below 70 mg/dL (3.9 mmol/L) is considered low, and blood sugar at or below this level “can be harmful.”  CMS Ex. 18 at 2-3; *see also* CMS Ex. 2 at 4.

Despite assessing R1 around 3:10 a.m., Nurse Balderson did not attempt to contact R1’s physician or emergency services until 3:50 a.m. and 3:55 a.m., respectively.  P. Ex. 14 at 2; CMS Ex. 9 at 7.  Under the facility’s policy, when there is a significant change in a resident’s condition, staff is required to “promptly notify” the resident’s physician, but Nurse Balderson failed to do so for R1.  CMS Ex. 15 at 1.  This amounted to neglect and was likely to cause serious harm to R1.  The facility was therefore out of compliance with the requirement to prevent neglect.

The same facts also support the facility’s noncompliance with the requirement to provide services in accordance with professional standards of practice.  42 C.F.R. § 483.25.  Absent contrary evidence, it is “reasonable to presume” that a facility’s own resident-care policies reflect professional standards of quality.  *Rockcastle Health & Rehab. Ctr.*, DAB No. 2891 at 19 (2018) (citing *Perry Cnty. Nursing Ctr.*, DAB No. 2555 at 9 (2014), *aff’d*, 603 F. App’x 265 (5th Cir. 2015) (internal quotation marks omitted)).  Thus, Nurse Balderson’s failure to promptly notify R1’s physician in accordance with the facility’s physician-notification policy also puts the facility out of compliance with the requirement to ensure R1 received treatment and care in accordance with professional standards of practice.  42 C.F.R. § 483.25; *Bivens Mem. Nursing Home*, DAB No. 2771 at 9 (2017) (explaining that a facility’s failure to comply with its own policies “can support a finding that the facility did not achieve compliance with the regulatory standard.”); *Hanover Hill Health Care Ctr.*, DAB No. 2507 at 6 (2013); *Life Care Ctr. at Bardstown*, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency).

Page 10

Petitioner does not specifically address whether R1 had a “significant” change in condition that required prompt physician notification when she was initially assessed by Nurse Balderson.  In any case, as explained below, the evidence submitted by Petitioner related to this issue does not create a genuine dispute.

Petitioner’s expert, Pearl Merritt, EdD, MS, MSN, RN, FAAN, claims that R1 experienced recurrent episodes of low blood sugars and that R1’s blood sugar was “frequently in the 40s.”  P. Resp. at 7 (citing P. Ex. 17 at 6-7).  But that could—at most—support an inference that blood sugar in the 40s was not a significant change in condition for R1.  That evidence does not speak to whether R1 experienced a significant change in condition when her blood sugar fell all the way down to 21.  Notably, in a subsequent interview with the surveyor, and consistent with Dr. Merritt’s claim, R1’s family member stated that R1’s blood sugar “went low every once in a while, but it had never gotten as low as 21.”  CMS Ex. 2 at 6; CMS Ex. 17 at 8 (surveyor notes of R1’s family member stating in an interview that R1’s blood sugar “has gone below normal a few times, but never that low.”)

R1’s critically low blood sugar was, moreover, only part of Nurse Balderson’s initial assessment, which also found R1 to be unresponsive, to have cold and clammy skin, and to be frothing secretions out of her mouth.  R1’s frothing at the mouth is particularly alarming and yet Petitioner does not argue or submit evidence to dispute its significance.  And Petitioner submits no evidence to create a genuine dispute that the different aspects of R1’s condition, taken together, represented a significant change in R1’s condition that required prompt physician notification.  Petitioner’s attempts to point out that R1’s vital signs were within normal limits and that R1 had “long-standing, chronic medical conditions” are unavailing as those points are ultimately irrelevant in light of the other serious aspects of R1’s condition.  P. Ex. 17 at 8-9, 11; P. Resp. at 7-8.

To be sure, Petitioner’s expert, Dr. Merritt, opines that there was no failure by Nurse Balderson to follow the change in condition protocol because Nurse Balderson attempted to contact the physician, followed the prescribed treatment for low blood sugar, continued to monitor the resident, and transferred the resident to the hospital when she determined that the resident was not responding even after the resident’s blood sugar went up.  P. Ex. 17 at 14; P. Resp. at 16.  Dr. Merritt also opines that it was “appropriate” for Nurse Balderson to contact the physician when she did, which was “as soon as it became clear to Nurse Balderson that the Glucagon treatment was not bringing [R1’s] blood sugar back to a normal level at a satisfactory rate.”  P. Ex. 17 at 8; P. Resp. at 8-9.

Dr. Merritt’s conclusion about whether Nurse Balderson complied with the facility’s policy, however, side-steps the threshold issue of whether R1 had a significant change in condition when initially assessed that required Nurse Balderson to notify the physician promptly.  Whether Nurse Balderson eventually contacted the physician is immaterial.

Page 11

Dr. Merritt’s conclusion is also narrowly focused on R1’s low blood sugar, ignoring the other serious aspects of R1’s condition, including her frothing out of her mouth.  P. Ex. 17 at 8.  But even assuming both that R1’s low blood sugar was the only relevant concern and that it was appropriate to wait to observe the resident’s response to the administration of Glucagon, Nurse Balderson still did not contact the physician promptly.  The instructions for administering Glucagon provide that “[a]n unconscious patient will usually awaken within 15 minutes following the glucagon injection” and that “[i]f the response is delayed . . . *emergency aid should be sought*.”  CMS Ex. 2 at 5 (emphasis added).  Dr. Merritt acknowledges that the standard of practice is to administer the initial dose of Glucagon and then re-check the resident’s blood sugar within 10-15 minutes.  P. Ex. 17 at 8.  But she does not otherwise address the instructions about when to seek emergency aid.  It is undisputed that, 10 minutes after the Glucagon was administered, R1’s blood sugar merely increased to 40; it took an *additional* 20 minutes for R1’s blood sugar to increase to 59; and throughout that time R1 remained unresponsive.  Thus, even assuming it was appropriate to wait 15 minutes after administering the Glucagon, R1’s condition after those 15 minutes—still unresponsive with harmfully low blood sugar—still required Nurse Balderson to notify R1’s physician and emergency services.  Yet Nurse Balderson did not contact the physician or emergency services then and did not do so until 3:50 a.m.—at least 20 minutes *after*the period to observe the resident’s response to the Glucagon.  That delay still puts the facility out of substantial compliance.

As for Petitioner’s remaining arguments, I disagree with Petitioner that there was no good or service that R1 needed but was not provided.  P. Resp. at 6.  At the time Nurse Balderson found R1 with a “significant” change in condition, R1 needed staff to promptly notify her physician so that the physician could provide his input on her care.  R1 needed staff to provide care in accordance with facility-care policies directed towards meeting resident needs.  The facility failed to provide such necessary “goods and services” based on Nurse Balderson’s delay.  *See also*State Operations Manual (SOM), Appendix PP at 80 (rev. 173, eff. Nov. 28, 2017) (examples of neglect include the “[f]ailure to identify, assess, and/or contact a physician and/or prescriber for an acute change in condition, and/or a change in condition that requires the plan of care to be revised to meet the resident’s needs in a timely manner”).

Petitioner also repeatedly argues that the hospital physician ultimately agreed with Nurse Balderson’s course of treatment before R1’s transfer to the hospital.  P. Resp. at 6 (citing CMS Ex. 13 at 2, 17); *see also* P. Resp. at 11.  In support, however, Petitioner does not rely on the testimony of the hospital physician.  Instead, Petitioner appears to rely on a note in R1’s hospital documentation providing, “[t]he history from nurses notes was reviewed:  and I [the hospital physician] agree with what is documented, up to this point.”  CMS Ex. 13 at 2.  Another note indicates that R1’s altered mental status was “likely related to Sepsis.”  CMS Ex. 13 at 17.  The note concerning the hospital physician’s agreement “with what is documented” is too short and ambiguous to reasonably support Petitioner’s reading.  Significantly, there is no indication that, when

Page 12

he added that note, the hospital physician had even considered the facility’s physician‐notification policy, including whether Nurse Balderson complied with that policy or whether her failure to comply put R1 at risk of more than minimal harm.  The hospital note therefore does not address a material fact in this case or whether the facility complied with its own policy and, in turn, the regulations.

Finally, Petitioner also points out that R1’s urinary tract infections (and related sepsis) and Parkinson’s disease were the major contributors to her eventual death.  P. Ex. 17 at 5‐6; P. Resp. at 6 (citing CMS Ex. 13 at 2, 17), 11.  But the major contributors to R1’s death are irrelevant here.  The facility’s noncompliance is based on the finding that Nurse Balderson’s delay in notifying the physician was likely to cause R1 serious harm, not that it caused her death.

**Failure to implement policies and procedures to prevent neglect and failure to investigate allegations of neglect:  42 C.F.R. §§ 483.12(b)(1), 483.12(c)(2)**

A facility must develop and implement written policies and procedures that, among other things, prohibit and prevent neglect.  42 C.F.R. § 483.12(b)(1).  Additionally, in response to allegations of abuse or neglect, a facility must have evidence that all alleged violations are “thoroughly investigated.”  42 C.F.R. § 483.12(c)(2).

According to its own written policies, “the facility has developed operational policies and procedures . . . for the prevention, *identification*, investigation, and reporting of . . . neglect,” and “[t]he facility’s purpose is to assure that the facility is doing all within their control to prevent occurrences.”  CMS Ex. 15 at 3 (emphasis added).  Under its policies for “Recognizing Signs and Symptoms of Abuse/Neglect,” the facility defines “neglect” as the “failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness” (which also mirrors the regulatory definition).  CMS Ex. 2 at 18; *see also*P. Ex. 10 at 1; 42 C.F.R. § 488.301.  The policy adds that signs of physical neglect include, among others, “inadequate provision of care.”  CMS Ex. 2 at 18; *see also* P. Ex. 10 at 2.

Despite these policies in place for identifying neglect, the facility’s Administrator and Director of Nursing (DON) interviewed Nurse Balderson and reviewed documentation related to the incident with R1 and determined that “there was no indication of any abuse or neglect of Res. #1.”  P. Ex. 15 at 2; P. Ex. 16 at 2; P. Ex. 8 at 1; P. Ex. 9 at 1; P. Resp. at 1.  Their determination, which is not binding, overlooked the signs of R1’s neglect.  As explained above, Nurse Balderson failed to comply with the physician-notification policy.  She delayed notifying R1’s physician, which served to deprive R1 of her physician’s timely input and resulted in R1’s neglect (as defined by the regulations and the facility’s policies).  There can be no real dispute that Nurse Balderson’s delay also amounted to “inadequate care,” a sign of physical neglect per facility policy.  The

Page 13

facility’s failure to recognize those facts puts the facility out of compliance with the requirement to implement policies preventing neglect.  42 C.F.R. § 483.12(b)(1).

The facility, moreover, did not conduct any investigation of the underlying incident, much less a thorough one as required by regulation.  It is undisputed that there was no documentation of any interviews with relevant witnesses, including the other certified nursing assistants who were present that night, and no written analysis of the facility’s findings.  *See*CMS Ex. 14 at 1-2 (disciplinary note containing statement from Nurse Balderson).

Nurse Balderson’s delay in notifying R1’s physician after finding R1 unresponsive, with On this point, Petitioner mainly argues that “there was no allegation or report of abuse or neglect for the facility to investigate.”  P. Resp. at 13-14.  Petitioner’s argument is unavailing, however, in light of the Departmental Appeals Board (Board) decision in *Ridgecrest Healthcare*, which holds, in part, that even if no staff member reports abuse (or neglect in the case at hand), a facility is required to investigate “allegations of circumstances” or “allegations of facts” that raise the possibility that abuse or neglect occurred.  DAB No. 2598 at 13-14 (2014).  Thus, no specific report or allegation from an individual is needed to trigger the requirement to investigate.  The allegation of facts requiring the facility to “thoroughly” investigate in this case include harmfully low blood sugar, and secretions frothing out of her mouth.  The facility did not investigate the incident at all and was therefore out of substantial compliance.  42 C.F.R. § 483.12(c)(2).

**Failure of administration:  42 C.F.R. § 483.70**

Under 42 C.F.R. § 483.70, a facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

In this case, the facility failed to administer its resources effectively and efficiently.  There is no dispute that the facility was aware that Nurse Balderson was cited by the Texas Board of Nursing for her poor care in the past and that her license was on probation with terms that required her to be supervised indirectly by another registered nurse who was on-site.  CMS Ex. 19 at 1 (College Park Corporate Director of Clinical Services acknowledging “I have received a complete copy of the Order of the Board and am aware of the stipulations placed on [Nurse Balderson’s] license by the Texas Board of Nursing.”).  Yet the facility allowed Nurse Balderson to provide care to residents on multiple night shifts without such supervision, including the night of the incident with R1.  CMS Ex. 18 at 8.  The failure to ensure that another registered nurse was on-site to supervise Nurse Balderson is attributable to the facility’s management who is responsible for allocating its staffing resources appropriately.  CMS Ex. 2 at 61 (The facility’s Administrator stating in an interview with the surveyor that “because of their mistake,

Page 14

[Nurse Balderson] worked over 20 night shifts since December without another RN supervising her according to her probation terms.”).

Petitioner argues that CMS and this tribunal have no authority to “enforce” the Texas Board of Nursing’s Order against Petitioner since Petitioner is not a party to the order.  P. Resp. at 16.  Petitioner’s argument is misplaced, however, as the issue is not whether there is authority to enforce the agreed order, but whether Petitioner was in substantial compliance with the regulations.  Relevant here, the same regulation requiring facilities to be administered “effectively and efficiently” includes subsections requiring facilities to “operate and provide services in compliance with all federal, state, and local laws, regulations, codes,” and requiring professional staff to be “licensed, certified, or registered in accordance with applicable State laws.”  42 C.F.R. § 483.70(b), (f)(2).  Thus, administering a facility includes ensuring that facility staff comply with the stipulations placed on their professional licenses.  Here, the facility’s management failed to administer its resources to ensure that Nurse Balderson was indirectly supervised as required by the state nursing board.  That failure placed those residents under the care of Nurse Balderson at likely risk of serious harm.

I disagree with Petitioner’s suggestion that it nevertheless complied with the agreed order because the facility’s DON was “less than ten minutes away” and “available by phone.”  P. Br. at 3.  The agreed order, in fact, states plainly that Nurse Balderson “SHALL be supervised by a Registered Nurse . . . who is on the premises.”  CMS Ex. 4 at 6.  Thus, the clear terms of the agreed order did not allow Nurse Balderson to be supervised by a nurse who was simply on call and not on the premises.

Finally, Petitioner’s expert, Dr. Merritt, opines that the “outcome in this case would have been no different if one, two, or five more nurses had been present with Nurse Balderson” because “Nurse Balderson acted appropriately and in accordance with accepted standards of nursing practice.”  P. Ex. 17 at 5-6.  As explained above, Nurse Balderson failed to follow the facility’s own physician-notification policy and so she did not act in accordance with accepted standards of nursing practice.  Moreover, the failure to ensure that Nurse Balderson was properly supervised as required by the agreed order also placed all of the residents under Nurse Balderson’s care, not just R1, at likely risk of serious harm.

**Immediate Jeopardy**

CMS determined that each of the deficiencies cited posed immediate jeopardy, which exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301; CMS Exs. 1-2.  CMS’s determination as to the level noncompliance, which includes any immediate jeopardy finding, must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c). ****The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities

Page 15

a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presents evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *Barbourville Nursing Home*, DAB No. 1931 at 27-28 (2004) (citing*Koester Pavilion*, DAB No. 1750 (2000)); *Daughters of Miriam Ctr.*, DAB No. 2067 at 7, 9 (2007).

Petitioner complains that R1 was the only resident at issue for the deficiencies cited and that there was no “prospective” harm identified by the surveyor at the time of the survey.  P. Br. at 14-15; P. Ex. 17 at 15-16.  These arguments are unavailing.  CMS determined that the scope of the noncompliance was “isolated” or “when *one* or a very limited number of residents or employees is/are affected.”  SOM, chap. 7, § 7410.2.1 (Rev. 63, Sep. 10, 2010) (emphasis added).  Thus, even assuming the deficiencies involved one resident only, that would not create a genuine dispute about whether CMS’s determination is clearly erroneous.  Additionally, CMS determined that the immediate jeopardy period, March 6 through 8, 2018, ended before the survey took place in April 2018 and so whether the surveyors were able to identify “prospective harm” at the time of the survey is irrelevant to the issue of whether the immediate jeopardy period at issue is clearly erroneous.

Petitioner then repeats its substantial compliance arguments.  Notably, Petitioner argues that the hospital-treating physician “confirmed” both that the facility’s actions did not cause R1 *any*harm and that R1’s death was not the result of anything the facility did or failed to do.  P. Br. at 14-15.  Again, however, Petitioner relies, not on the testimony of the hospital physician, but the same hospital notes stating that R1’s altered mental status was “likely related to Sepsis” and stating that the hospital physician had “agreed with what [was] documented, up to [that] point.”  P. Br. at 14-15 (citing CMS Ex. 13 at 1, 2, 17).  Again, the notes do not mention harm and are too ambiguous to support a reasonable inference that the physician “confirmed” that the facility’s actions (or inactions) did not cause R1 any harm.  And there is no indication the hospital physician considered whether the staff’s compliance (or noncompliance) with the facility’s own physician-notification policy caused or was likely to cause R1 any harm.  Finally, as noted, even if the facility did not cause R1’s death, the specific causes of R1’s death are irrelevant to the issue of whether the facility’s noncompliance still caused or was likely to cause serious harm.

In sum, Petitioner failed to show there is a genuine dispute that the immediate jeopardy determinations in this case were clearly erroneous.

**Reasonableness of CMP amounts**

Based on the facility’s immediate jeopardy noncompliance, CMS imposed a $12,004 per day CMP, which is an amount in the middle of the relevant range ($6,394 to $20,965).  CMS also imposed a $505 per day CMP for the non-immediate jeopardy period, which is

Page 16

an amount at the low end of the relevant range ($105 to $6,289).  82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).

In determining the reasonableness of the penalty amounts imposed, I look to the factors at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency, the facility’s compliance history, its financial condition, and its degree of culpability.  The Board has held that the CMP amount selected by CMS is presumptively reasonable based on the regulatory factors listed above and that the burden is on the SNF “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  *Crawford Healthcare & Rehab.*, DAB No. 2738 at 19 (2016).

Petitioner does not argue that that the period of noncompliance should be reduced, i.e., that it returned to substantial compliance before April 11, 2018.  Petitioner also does not specifically argue that the CMPs imposed are unreasonable *based on the regulatory factors.* Petitioner simply reiterates its arguments that it was in substantial compliance, but those arguments have been addressed above already.  Petitioner therefore has not shown that the CMP amounts imposed are unreasonable based on the regulatory factors.

Considering the factors, anyway, I find the CMP amounts reasonable.

Petitioner submits no evidence showing that its financial condition requires reducing the penalty amounts to be reasonable.

As for the facility’s compliance history, Petitioner was found out of compliance with two life-safety-code requirements and one health-and-safety requirement in a recent survey, which, if anything, supports penalty amounts higher than the minimums in the relevant ranges.  CMS Ex. 16 at 7.

Petitioner’s noncompliance was also very serious.  Each of the five deficiencies at issue was cited at the immediate jeopardy level, which meant that they caused or were likely to cause at least serious harm.  Petitioner failed to submit evidence to create a genuine dispute that Nurse Balderson’s delay in notifying R1’s physician was likely to cause R1 serious harm when she was unresponsive and her blood sugar level was harmfully low.  The facility’s subsequent failure to identify and investigate R1’s neglect allowed Nurse Balderson to continue providing care, which put other residents at likely risk of similar neglect and harm.  *See* CMS Ex. 18 at 9, 11.  Finally, it is undisputed that Nurse Balderson’s nursing license was on probation with terms for her poor past care and that she was not permitted to provide care without supervision by another registered nurse on‐site.  The facility’s failure to ensure Nurse Balderson was supervised as required by the state nursing board placed all of the residents under her care at likely risk of serious

Page 17

harm.  *See* CMS Ex. 18 at 2.  The seriousness of the facility’s noncompliance supports CMPs amount higher than minimum in the relevant range.

Petitioner’s culpability was also significant.  The majority of the deficiencies were based on the failures of both staff and management to comply with the facility’s own written policies, including the facility’s physician-notification policy and the facility’s neglect policy.  There is no excuse for such failures, and the facility’s culpability therefore supports the CMP amounts imposed.

For all of these reasons, I find the CMP amounts imposed reasonable.

VI. Conclusion

I find that the record is sufficiently developed and the only reasonable conclusion that can be drawn from the undisputed facts is that, from March 6, 2018 through April 11, 2018, the facility was not in substantial compliance with Medicare program requirements; the immediate jeopardy determinations were not clearly erroneous; and the penalties imposed, $12,004 per day for immediate jeopardy noncompliance and $505 per day for non-immediate jeopardy noncompliance, are reasonable.  I therefore grant CMS’s motion for summary judgment.


          /s/
        Catherine Ravinski

                      Administrative Law Judge
      1. Notably, the record includes evidence of two different standing orders for R1’s Glucagon: one (signed by Dr. Wusterhausen) that was initiated at Weatherford Rehab, where R1 previously resided, and another (signed by Dr. Kumar) initiated at College Park the night of the incident with R1. P. Ex. 6; P. Ex. 7 at 4. CMS argues that Nurse Balderson failed to notify the physician when administering the Glucagon as specifically required by the Weatherford order. CMS Mot. at 7. On the other hand, Petitioner argues that the College Park order was the relevant order in effect at the time of the incident and that order did not require physician notification. See, e.g., P. Resp. at 7-8. Though it might be reasonable to question the validity of the College Park order, given how it was initiated just minutes before Nurse Balderson first assessed R1, as explained below, it is ultimately immaterial to resolve whether the order was invalid. P. Ex. 7. For purposes of summary judgment, I will accept Petitioner’s position that the College Park standing order, which did not have its own physician-notification requirement, was in effect at the time of the incident with R1. back to note 1 Back to top
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