Ennis Care Center, DAB CR5991 (2021)

DECISION

I find that Petitioner Ennis Care Center was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.10(g)(14)(i)(B), 483.25, 483.25(d)(1),(2), and 483.50(a)(2)(ii) and that the civil money penalties imposed are reasonable.

I.  Background

Petitioner, Ennis Care Center, is a skilled nursing facility (SNF) located in Ennis, Texas, that participates in the Medicare program.  On July 15, 2019, the Centers for Medicare and Medicaid Services (CMS) notified Petitioner that it was not in substantial compliance with Medicare participation requirements, following a survey completed by the Texas Health and Human Services Commission on June 20, 2019, and that the noncompliance for several participation requirements represented immediate jeopardy to resident health and safety.  CMS Exhibit (Ex.) 4. 

Following further administrative review, CMS notified Petitioner on August 14, 2019 that the enforcement actions identified in the July 15, 2019 notice had been revised and Federal Civil Money Penalties (CMPs) imposed, as follows:

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• $20,220.00 per instance for the instance on October 2, 2018, described at deficiency F0773 (S/S: J);
• $20,220.00 per instance for the instance on January 10, 2019, described at deficiency F0580 (S/S: J);
• $20,220.00 per instance for the instance on January 11, 2019, described at deficiency F0684 (S/S: J);
• $10,515.00 per instance for the instance on May 19, 2019, described at deficiency F0689 (S/S: J); and
• $20,220.00 per instance for the instance on June 19, 2019, described at deficiency F0880 (S/S: D). 

CMS Ex. 3 at 1.

On October 11, 2019, Petitioner filed a timely request for hearing before an administrative law judge (ALJ).  On October 15, 2019, Judge Leslie A. Weyn issued an Acknowledgment and Standing Prehearing Order (Prehearing Order), setting forth prehearing procedures.  This case was originally assigned to Judge Weyn and was transferred to me on September 13, 2021.   Pursuant to the Prehearing Order, the parties submitted prehearing exchanges consisting of briefs, proposed exhibits, and written direct testimony of proposed witnesses.  CMS filed a prehearing brief and offered 18 proposed exhibits (CMS Exs.), including the written direct testimony of two witnesses (CMS Exs. 17-18).  Petitioner filed objections to CMS Exs. 1-5, 12, 14, 16, 17, and 18 and requested to cross‑examine both of CMS’s witnesses.  Petitioner filed a prehearing brief and offered exhibits (P. Exs.) 1‑6, 8-10, 14-16, 19-20, 22, 24-27, 29-30, and 34-46, including the written direct testimony of seven witnesses (P. Exs. 38, 40-45).  CMS filed objections to P. Exs. 1, 4, 5, 19, 24, 34, 36, 37, 38, and 46, and did not request to cross-examine any of Petitioner’s witnesses. 

On April 13, 2021, Judge Weyn conducted a telephone prehearing conference.  In a Summary of Prehearing Conference and Notice of Hearing dated April 15, 2021, Judge Weyn overruled Petitioner’s objections to CMS Exs. 1-5, 12, 14, 16-18 and admitted CMS Exs. 1-16 into the record, with CMS Exs. 17 and 18 to be admitted at the hearing after witness authentication.  At the prehearing conference, CMS withdrew its objection to P. Ex. 1.  Judge Weyn overruled CMS’s remaining objections to Petitioner’s exhibits and admitted P. Exs. 1-6, 8-10, 14-16, 19-20, 22, 24-27, 29-30, and 34-46 into the record.  A hearing was initially scheduled in this matter for June 2, 2021 but was subsequently postponed because of the illness of a CMS witness and rescheduled for June 29, 2021.

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CMS subsequently withdrew the written testimony and declarations of Daniel J. McElroy (CMS Ex. 18) and Robin Allen (CMS Ex. 17).  As a result, a hearing for the purpose of cross-examining these witnesses was not necessary.  With the parties’ agreement, Judge Weyn set deadlines for a final round of briefing to address how the absence of Ms. Allen’s testimony changes the evidence in support of the deficiencies alleged by CMS.  The parties filed their final briefs (CMS Opening Br. and P. Closing Br.), and this matter is now ready for a decision on the merits. 

II.  Discussion

A.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(g)(14)(i)(B).  My findings of facts and conclusions of law are set forth in bold and italic text in the discussion captions of this decision. 

42 C.F.R. § 483.10(g)(14)(i)(B) provides as follows: 

(i) A facility must immediately inform the resident; consult with the resident's physician; and notify, consistent with his or her authority, the resident representative(s), when there is -

* * * * *

(B) A significant change in the resident's physical, mental, or psychosocial status (that is, a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications)

Id.  (2019). 

CMS asserts that there was a significant change in Resident #1’s condition beginning on January 10, 2019, as demonstrated by four falls, repeated elevated heart rates, frequent complaints of pain, ongoing nausea, medication refusals, refusals to comply with transfer requirements, random bouts of confusion, and a reddish purple bruise on her back.  CMS Opening Br. at 6-7.  Petitioner argues that there was never a significant change in Resident #1’s condition prior to the time she was found unresponsive that required physician notification.  Petitioner alleges that Resident #1 did not experience any new symptoms beginning on January 10, 2019 and any symptoms she experienced were treated appropriately and did not require notifying the physician under his standing orders.  P. Closing Br. at 16.  After carefully considering the record, I find that, without testimony from the surveyor, Robin Allen, there is prima facie evidence to establish that there was a significant change in Resident #1’s condition as of January 10, 2019 and

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Petitioner failed to “consult with the resident’s physician” at that time.  CMS Opening Br. at 5, 7. 

Resident #1 was a 56 year old woman, who had been admitted to the facility on June 15, 2018 with diagnoses of Type 2 diabetes with diabetic neuropathy, bipolar disorder, anxiety disorder, chronic pain syndrome, chronic obstructive pulmonary disease (COPD), hypertensive heart disease and heart failure, arthritis (multiple sites), muscle weakness, unspecified abnormalities of gait and mobility, and unspecified lack of coordination.  Interestingly, the diagnosis of obesity, which is frequently noted by Petitioner, was not included in the list of Active Diagnoses.   CMS Ex. 8 at 5, 8.  The Care Plan also noted a risk of falls and fall related injuries with episodes of attempting to self transfer without assistance.  P. Ex. 6 at 6.

Nursing notes and other facility records document the following:

• On January 6, 2019 at approximately 12:30 AM, Resident #1 was found lying on the floor beside her bed.  She reported that she slipped when she got up from her wheelchair and attempted to put herself to bed.  She was educated to use the call light and to wait for assistance for transfers from chair to bed.  Neurological assessments were within normal limits.  She later complained that her head hurt, but skull x-rays showed no fracture.  CMS Ex. 8 at 3. 
• On January 9, 2019 at 2:06 AM, Resident #1 was reported to have fallen from her wheelchair while trying to transfer to bed by herself.  She denied hitting her head and hourly monitoring was initiated.  Vital signs of blood pressure (BP) 135/70, heart rate/pulse of 75, respiration rate of 18, and temperature of 97.2 were recorded.  CMS Ex. 8 at 2. 
• On January 10, 2019, at 3:19 PM, Resident #1 was observed to be attempting to get up alone.  She was re-educated on 2:1 transfer status.  She reportedly refused all medications on that shift, saying she didn’t feel well, and this was the only way to feel better.  CMS Ex. 8 at 1. 
• On January 10, 2019 at 4:30 PM, she was again found trying to get out of bed alone.  She complained of right shoulder pain and PRN Biofreeze was administered.  Resident #1 was re-educated to 2:1 status.  CMS Ex. 8 at 1. 
• On January 10, 2019 at 8:01 PM, Resident #1 hit her call light and complained of nausea.  Zofran was administered per MD protocol.  CMS Ex. 8 at 1. 

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•  On January 10, 2019 at 9:00 PM, Resident #1 was found by an aide face down on the floor.  She denied pain and hitting her head, but a bruise was noted on the left side of the back.  Vital signs taken at this time included BP of 130/66, pulse of 129, and temperature of 97.5.  CMS Ex. 8 at 1. 
• On January 10, 2019 at approximately 10:30 PM,  While the nursing note documenting this incident was written at 3:33 AM on January 11, 2019, the interior of the note indicates the resident was found at 2230.  CMS Ex. 8 at 1.  It is unclear when the vital signs reported in this treatment note were taken.  Resident #1 was found on the floor by a nurse walking by.  She was face down on the floor towards the bathroom floor with a comforter under her head.  She stated she slid out of bed on purpose because staff was taking too long to come to her.  She was placed back in bed with a Hoyer lift and again re-educated to use her call light and wait for staff to help get in and out of bed.  Vitals at that time included BP of 137/76, pulse of 104, and respiration rate of 20, although she was reported to have refused to have vitals taken twice previously.  CMS Ex. 8 at 1. 
• On January 11, 2019 at 9:00 AM,  While the nursing note documenting this incident was written at 11:36 AM, the interior of the note indicates the resident was found at 0900.  CMS Ex. 8 at 1.  It is unclear when the vital signs reported in this treatment note were taken. a housekeeper observed Resident #1 on her hands and knees next to the bed and rolled onto the floor.  She was returned to bed with a Hoyer life with no injuries noted.  Zofran was administered for complaints of nausea.  Vital signs were recorded as BP of 123/50, pulse of 98, temperature of 97.8, and respiration rate of 16.  CMS Ex. 8 at 1. 
• At 12:20 PM on January 11, 2019, the resident was found face down on the floor next to the bed.  She was nonresponsive with no pulse or respirations present. Life saving efforts were started, but ceased after verification that she was DNR (do not resuscitate).  Resident #1 was pronounced dead at 12:36 PM.  CMS Ex. 8 at 1. 

The regulatory requirement to notify a resident’s physician in 42 C.F.R. § 483.10(g)(14)(i)(B), is triggered by, among other circumstances, a “significant change in the resident’s physical, mental, or psychosocial status (that is, a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications.)”  Thus, the initial question to be resolved here is whether Resident #1 experienced a significant change in her physical, mental, or psychosocial status on January 10, 2019.

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Petitioner argues that “there was never a significant change in Resident #1’s condition prior to the time she was found unresponsive that required physician notification.”  P. Closing Br. at 16.  Petitioner supports this argument by addressing each factor cited by the surveyor individually.  I concur with the initial statement that there is no credible support in the record for the statement that “Resident #1 complained of chest pain.”  CMS Ex. 5 at 3.  This statement is apparently based on an unidentified complainant who allegedly overheard Resident #1 tell staff that she could not breathe and her chest was hurting.  CMS Ex. 5 at 6.  While I am not persuaded by the unsupported characterization of this unidentified individual as a paranoid schizophrenic who “is known to make frequent outlandish complaints” (P. Closing Br. at 12), I do not find it likely that nursing staff would have failed to record such a complaint, given that other complaints by Resident #1 were duly recorded in the nursing notes. 

Petitioner next argues that many of the findings cited by the surveyor in support of finding a significant change of position were not “new.”  P. Closing Br. at 9, 12, 16.  I would concur that many of the complaints of the resident and the medical findings were not new.  However, I do not agree as to the significance of that conclusion. 

The Departmental Appeals Board (Board or DAB) has held that the fact that a resident has experienced a condition previously does not make the recurrence of that condition insignificant.  Claiborne-Hughes Health Ctr., DAB No. 2179 at 10 (2008), aff’d, Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839 (6th Cir. 2010).  On appeal, the U.S. Court of Appeals for the Sixth Circuit stated: 

The DAB has also rejected similar arguments in the past.  See, e.g., NHC Healthcare Athens, DAB 2258 at 6 (2009) (noting that the existence of a condition does not preclude a regulation’s requirement to contact the physician upon the condition’s recurrence).  Indeed, the DAB’s regulatory interpretation here is reasonable given that many residents seek admission into skilled nursing facilities in the specific hopes of preventing the recurrence of past life-threatening health episodes. 

Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839 (6th Cir. 2010).

Thus, whether new or pre-existing, all of Resident #1’s complaints and findings must be considered in order to determine whether there was a significant change in condition on January 10, 2019.  As the Board has stated: 

The determination of whether an observed change in health status is “significant” within the meaning of section

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483.10(b)(11)(i)(B)  This regulation was revised and redesignated as 42 C.F.R. § 483.10(g)(14)(i)(B) on October 4, 2016.  81 Fed. Reg. 68,688, 68,853 (2016). should account for all of a resident’s pertinent clinical circumstances, including the magnitude of any risk of harm to the resident from a delay in consulting with the physician (or delaying a potentially necessary change in treatment).

Columbus Nursing & Rehab. Ctr., DAB No. 2505 at 12 (2013).

Resident #1 had a history of COPD, and the record contains reports of shortness of breath.  CMS Ex. 8 at 8; P. Ex. 3 at 1-4.  Petitioner asserts that Resident #1 never experienced respiratory distress and the shortness of breath was on exertion only.  P. Closing Br. at 16.  I would again concur that there is no evidence of respiratory distress during the time period from January 9, 2019 through January 11, 2019.  As indicated by Petitioner’s expert witness, “Resident #1 never experienced respiratory distress (as her respirations were documented every 15 minutes as even and unlabored, and her respiratory rate was normal.).”  P. Ex. 38 at 10.  

In considering whether the reported shortness of breath during the relevant time period was evidence of a significant change of condition, I initially note that there are conflicts in the record regarding this symptom.  There is very little documentation of complaints or observations of shortness of breath in the nursing notes.  There is no record of any complaints or observations of shortness of breath in the nursing notes from January 9, 2019 through January 11, 2019.  CMS Ex. 8 at 1-2.  Written statements from the facility’s staff do reference shortness of breath, however.  Ashley Carver, LVN, indicated that at 9:00 PM on January 10, 2019, she had been notified by one of the aides that Resident #1 had been found on the floor.  She described Resident #1 as being “slightly short of breath,” from the event itself and from the movement required to get her back to bed.  Resident #1 refused the offer to elevate the head of the bed, so oxygen was applied as a precaution (under a standing order protocol  The only standing order for oxygen in the record was from Dr. Brown, who authorized oxygen at 2 liters/MIN for O2 saturation levels  of less than 90%.  P. Ex. 5 at 3.  No oxygen saturation levels were reported in the nursing records for this incident or in any other record for the period from January 9, 2019 through January 11, 2019.  CMS Ex. 8 at 1-2.  to do this as a nursing judgment), although Ms. Carver was unable to recall if she was the one who applied the oxygen.  There is no report of shortness of breath or oxygen administration in the nursing note completed by Ms. Carver for this incident.  CMS Ex. 8 at 1.   Ms. Carver

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stated Resident #1 never appeared to be in respiratory distress and her respiration rate remained normal.  P. Ex. 3 at 1. 

The other notation of shortness of breath during this period was in the statement of Shahara Dunbar, LVN.  Ms. Dunbar stated that on the morning of January 11, 2019, as she was walking down the hall, she observed Resident #1 with her leg hanging over the side of the bed, and that it looked like Resident #1 was trying to get out of bed without assistance.  There are no observations in the nursing notes of Resident #1 being observed trying to get out of bed unassisted on January 11, 2019.  The two observed attempts were recorded in the nursing notes from January 10, 2019 at 3:19 PM and 4:30 PM.  CMS Ex. 8 at 1.   Ms. Dunbar indicated that Resident #1 stated she was trying to get out of bed and couldn’t breathe and that it was not unusual for Resident #1 to become short of breath when she did any physical activity.  Ms. Dunbar stated Resident #1 was already on oxygen, through standing orders, and that Ms. Dunbar raised the head of the bed, after which Resident #1 was able to breathe normally.  Ms. Dunbar also stated that she then notified the charge nurse taking care of Resident #1, Tammy Henson, who went into the room with a pulse oximeter in her hand.  P. Ex. 3 at 4. 

It is troubling that Resident #1’s reported complaints of shortness of breath were not recorded on any nursing note for January 10, 2019 or January 11, 2019.  CMS Ex. 8 at 1‑2.  There is also no indication in the nursing notes that Resident #1 was using oxygen, when this was initiated, or the reasons for its use.  If, in fact, the charge nurse measured the resident’s oxygen level on January 11, 2019, as Ms. Dunbar suggests, this was never recorded in the nursing notes.  However, the fact that Resident #1 experienced shortness of breath to the degree that prompted someone to provide oxygen to her on January 10, 2019, through some time on January 11, 2019, demonstrates a concerning change in her condition and constitutes a pertinent clinical finding that must be considered under the Board’s holding in Columbus. 

In considering whether the elevated heart rate of 129 at the time of the fall on January 10, 2019 at 9:00 PM, was evidence of a significant change of condition (CMS Ex. 8 at 1), I note that there were, as alleged by Petitioner, numerous instances of an elevated heart rate prior to January 10, 2019.  P. Closing Br. at 10; P. Ex. 4 at 1.  A review of the Medication Record indicates many instances of an elevated pulse  The terms heart rate and pulse rate are used interchangeably in this record. rate since June 2018.  P. Ex. 9 at 2‑8.  However, in the days immediately preceding January 10, 2019, Resident #1’s pulse rate was not significantly elevated.  P. Ex. 9 at 8.  During the period from January 6, 2019 through January 8, 2019, her pulse rates ranged from 70 to 97, all within

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the normal range.  The normal pulse rate for adults ranges from 60 to 100 beats per minutes.  Johns Hopkins Medicine, Vital Signs (Body Temperature, Pulse Rate, Respiration Rate, Blood Pressure).  https://www.hopkinsmedicine.org/health/conditions-and-diseases/vital-signs-body-temperature-pulse-rate-respiration-rate-blood-pressure (last visited Nov. 5, 2021).   P. Ex. 10 at 1.  At the time of the fall at 12:30 AM on January 6, 2019, pulse was recorded as 76 in the nursing note describing that incident.  CMS Ex. 8 at 3.  Vital signs recorded at the time of the fall at 2:06 AM on January 9, 2019, included a heart rate of 75.  CMS Ex. 8 at 2.  In the Resident Incident Report from the January 9, 2019 fall, Resident #1’s pulse was also reported as 75.  CMS Ex. 8 at 48.  During the subsequent monitoring after the fall on January 9, 2019, pulse rates were recorded as 75, 82, 82, 76, 74, 77, 76, 78, 79, 82, 105, 90, 77, and 82, with only one measurement above the normal range.  P. Ex. 10 at 3.  On January 10, 2019, however, pulse rates remained at an elevated level nearly constantly throughout the day.  After recording the pulse rate of 129 at the time of the fall at 9:00 PM, rates were measured during the subsequent monitoring at 93, 103, 104, 101, 99, 101, 101, which was a substantial increase over the previous days.  Petitioner’s expert witness stated that after the initial reading of 129, within 15 minutes, Resident #1’s pulse returned to normal.  P. Ex. 38 at 7.  While it is true that her pulse was measured at 93 at the next reading, the witness fails to acknowledge that Resident #1’s pulse rates remained above the normal range for most of the day, as noted above.   CMS Ex. 8 at 1; P. Ex. 10 at 4.  The notable change in Resident #1’s pulse rate also demonstrated a change in her condition and a pertinent clinical finding to be considered.

Resident #1 also had a history of falls.  The Care Plan identified her as at risk for falls, with a history of attempting to self transfer without assistance and associated falls.  The falls were characterized as unavoidable, due to history of medication seeking and non‑compliance.  Interventions to address this problem were identified as continuing to educate the resident on the use of the call light for transfer assist.  P. Ex. 6 at 6-7. 

No falls or unusual behaviors were reported in the nursing notes from January 1, 2019 through January 5, 2019.  CMS Ex. 8 at 3-4.  At approximately 12:30 AM on January 6, 2019, Resident #1 told the certified nursing assistants (CNAs) that she was ready for bed.  She was told to go to her room and wait for them while they finished with another resident.  When the CNAs reported to her room, Resident #1 was observed to be lying on the floor beside the bed, stating that she slipped when she got up from her wheelchair to put herself to bed.  She was noted to be non-compliant with waiting for staff assistance and was educated again on this.  CMS Ex. 8 at 3.  While not reported in the nursing note from this incident, the Care Plan cited the January 6, 2019 fall and indicated that the resident refuses to call for assistance and becomes agitated with staff when they remind her to call for assistance.  The Care Plan then indicated that Resident #1 was seen on

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January 8, 2019 by “senior psych”  The identity of the “senior psych” who “saw” Resident #1 isn’t clear.  Petitioner alleges that “the psychiatrist was scheduled to see Resident #1 on 1/8/19” and later refers to the “physician/psychiatrist visit.”  P. Closing Br. at 7-8.  There are no treatment notes from this reported “visit.”  The only record of contact with “senior psych” is a telephone order dated January 8, 2018, changing the Depakote prescription from BID to TID.  P. Ex. 5 at 10.  This note was signed by an RN, PMHNP.  There is no evidence, however, that this individual actually met with or examined the resident. for a recent increase in behaviors, agitation, yelling out, and disproven accusations with recent medication reductions in the last two months.  The nursing notes from January 1, 2019 through January 8, 2019, do not contain any references to agitation, yelling out, or disproven accusations other than a reference on January 8, 2019, to notifying on call administration of resident accusations toward staff.  CMS Ex. 8 at 2.   P. Ex. 6 at 6, 10.  Medications were adjusted by increasing Depakote (divalproex) to three times a day (TID) from two times a day (BID).  CMS Ex. 8 at 2. 

There was then a dramatic increase in falls and unassisted transfer attempts beginning on January 9, 2019.  The evidence, including the facility’s own records, documents that Resident #1 attempted to transfer from bed to her wheelchair or vice versa without assistance on seven to nine occasions over the two day period beginning on January 9, 2019, with five resulting falls.  The written statement of Shahara Dunbar, LVN, suggests there may have been another attempt by Resident #1 to get out of bed unassisted on January 11, 2019.  P. Ex. 3 at 4.  Although she does not indicate the time of her observation, Ms. Dunbar stated when she was walking by Resident #1’s room on January 11, 2019, she observed that Resident #1 had a leg hanging over her bed and was complaining of being unable to breathe.  This incident was not included in the above tally, however, since it was not documented in the nursing notes.   As indicated above, falls were reported in the nursing notes on January 9, 2019 at 2:06 AM, January 10, 2019 at 9:00 PM and 10:30 PM, and January 11, 2019 at 9:00 AM and 12:20 PM.  CMS Ex. 8 at 1-2.  Nursing notes also documented attempts to get out of bed unassisted on January 10, 2019 at 3:19 PM and 4:30 PM.  CMS Ex. 8 at 1. Two additional attempts to transfer without assistance were recorded on an Every Hour Monitoring report for January 10, 2019, one at 7:00 AM and one at 11:00 AM.  CMS Ex. 8 at 105.  These incidents were not recorded in the nursing notes. 

The significant increase in falls and attempts to get out of bed unassisted, considered alone, demonstrate a significant change of condition.  Such a remarkable increase in the number of falls over a short period of time after a medication change should have triggered a consultation with the physician.  Moreover, while there was no history of

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throwing herself on the floor or other self destructive behaviors, Stephanie Cochran, an Assistant Director of Nursing (ADON), indicated in a written statement that she had been informed that Resident #1 “had been throwing herself on the floor intentionally recently,” establishing another concerning change in her condition.  P. Ex. 3 at 7.  Considering “all of a resident’s pertinent clinical circumstances,” as required by Columbus, the dramatic increase in the number of falls, with the reported associated physical findings of elevated pulse rate and bruising and physical complaints of shortness of breath, nausea, right shoulder pain, and not feeling well, a significant change in condition is established as of January 10, 2019. 

Petitioner argues the falls were the result of Resident #1 being “non-compliant with the staff’s instructions to wait for staff to assist with a transfer,” with the associated insinuation that this was simply willful behavior.  Petitioner indicated that the Care Plan was “updated to reflect that Resident #1 refuses to call for assistance (resulting in falls), and that she becomes extremely agitated (more anxious) and aggressive with the staff when they remind her to call for assistance.”  Petitioner states that “the care plan even notes that according to Dr. Brown, Resident #1’s falls had become unavoidable due to her continual refusal to comply with the facility staff’s requests and instructions.”  P. Closing Br. at 7.  An Incident Investigation report indicated “Resident [#1] known to be non‑compliant and continues to attempt self transfers.”  CMS Ex. 8 at 69.  When asked whether she slid out of bed “on purpose” on January 10, 2019, Resident #1 allegedly said she did.  CMS Ex. 8 at 61.  The nursing note indicated the resident had slid out of bed on purpose because the staff was taking too long to come to her.  CMS Ex. 8 at 1.  While it is apparently tempting to vilify Resident #1 and pin her demise on her own behaviors, it is very clear from the Care Plan that Resident #1 was subject to mental health impairments that were capable of producing these behaviors. 

There is no basis for finding that the increase in falls was the result of willful behavior.  According to the Care Plan, Resident #1 was diagnosed with bipolar disorder, unspecified.  The associated problems included impaired cognition, being forgetful, difficulty with realistic thoughts and goals, history of paranoia, and recent history of suicide attempts.  P. Ex. 6 at 1.  The Minimum Data Set documents Resident #1’s trouble concentrating on half or more of the days.  CMS Ex. 8 at 40.  The “CAA Worksheet 11:  Falls” identifies Resident #1’s “[i]mpulsivity or poor safety awareness” as a problem.  CMS Ex. 8 at 67.  These problems clearly could have contributed to Resident #1’s difficulty in complying with staff instructions regarding transfers.  The above evidence establishes that with the increase in falls resulting from failure to seek assistance when transferring, particularly after a change in medication for increased agitation, coupled with elevated heart rates, shortness of breath requiring oxygen, and nausea, there was a significant change in Resident #1’s condition as of January 10, 2019. 

In reaching this conclusion, I have considered the opinions of Petitioner’s witnesses.  Ashley Carver, LVN, opined that she cared for Resident #1 during the falls that occurred

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on January 10, 2019 at 9:00 PM and 10:30 PM, and “there was no need to call the physician because this resident did not experience a significant change.”  She cited as the basis for her opinion the fact that Resident #1’s neurological checks were normal and her pulse returned to normal within 15 minutes.  P. Ex. 3 at 1-2.  Ashlie Massey, LVN, similarly stated that there was “no need to contact the physician because there was no significant change in condition,” again citing normal neurological findings.  P. Ex. 3 at 3.  Pearl Merritt, ED.D., MS, MSN, RN, FAAN, Petitioner’s expert witness, offered her opinion that “there was never a significant change in Resident #1’s condition prior to the time she was found unresponsive that required physician notification.”  She supported her opinion by indicating that there was no need to call the physician because of Dr. Brown’s standing orders and the fact that none of her conditions were new.  P. Ex. 38 at 10. 

I have not given these opinions on the ultimate legal issue any weight because they did not address the notable increase in falls and attempts to self transfer after a medication change on January 8, 2019.  CMS Ex. 8 at 2.  As indicated above, it was the dramatic increase in the number of falls over a short period of time, coupled with the physical complaints and findings detailed above, that signified the significant change in condition, and these factors were not addressed in any of these opinions. 

Petitioner also urges that I adopt the conclusions of the Informal Dispute Resolution (IDR) process, which concluded there was no regulatory basis for the citation under F580.  Interestingly, but unsurprisingly, Petitioner only urges that I adopt the findings of the IDR when they support Petitioner’s position and makes no mention of the findings when they do not.  See P. Ex. 46 at 38, 48.  P. Closing Br. at 16.  I decline to give weight to the conclusions of this body for several reasons.  The record at the time of the IDR review is not identical to the record before me, which includes additional arguments and analysis by the parties.  The IDR review also did not address the role that mental health impairments may have played in Resident #1’s behaviors.  Moreover, I am guided by the statute and regulations, as well as decisions by the Board and courts, while the IDR cited as support the State Operations Manual Appendix PP.  For these reasons, while I considered the conclusions of the IDR process because they were part of the record, I have given them no weight. 

Having determined that there had been a significant change in Resident #1’s condition as of January 10, 2019, the next question is whether the facility immediately consulted with her physician, as required by 42 C.F.R. § 483.10(g)(14)(i)(B).  Petitioner initially argues that there was no need to notify the physician in this case because of the standing orders he had issued.  Petitioner asserts that “[w]hen a condition is expected as a natural part of the resident’s disease process, it is not necessary to contact the physician to advise of a ‘significant change’ when the change is completely anticipated and treatment orders are already in place.”  P. Prehearing Br. at 2 (internal citation omitted).  Petitioner also alleges that, with respect to falls, Dr. Brown’s “standing orders instruct the facility staff

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to treat the immediate symptoms (if any) after the fall, monitor the resident, begin neurological checks, and only contact the physician if the neurological checks show a pattern of abnormality, or if the symptoms are not relieved.”  P. Closing Br. at 5-6 (internal citations omitted).  In his own statement, Dr. Brown added that he would also expect to be called if there were a complication from a fall.  P. Ex. 4 at 1. 

I initially note that Dr. Brown’s standing orders did not address the situation presented here:  a recent onset of frequent, ongoing falls and problematic behaviors that were not resolved by the treatment authorized in the standing orders.  Moreover, Dr. Brown’s opinions as to when he wished to be notified are not relevant to the issue before me.  The relevant regulation makes it quite clear that when there is a significant change in a resident’s condition, immediate consultation is required, regardless of what Dr. Brown’s standing orders might be or whether he would expect to be called. 

Similarly, Petitioner’s expert witness states that “facility policy regarding physician notification confirms that in the case of an accident (i.e., a fall), notification is required only if the fall results in an injury and potentially requires physician intervention.”  P. Ex. 38 at 9.  While the facility policy certainly tracks the language of 42 C.F.R. § 483.10(g)(14)(i)(A), governing accidents, the issue in this case is whether Petitioner was in substantial compliance with 42 C.F.R. § 483.10(g)(14)(i)(B):  whether there was a significant change in the resident’s status triggering the regulatory requirement to consult with the physician. 

Petitioner then argues that, in fact, the treating physician had been notified.  Petitioner asserts:  “Contrary to the surveyor’s allegations, and although not required to do so under the standing orders or fall protocol, the physician was notified.”  There is a conflict in the record as to whether Dr. Brown was notified and who contacted Dr. Brown on that occasion, if there was a notification.  The surveyor’s report indicated that the ADON (Stephanie Cochran) notified the physician via text message. CMS Ex. 5 at 7; CMS Ex. 6 at 1.  However, in her written statement, ADON Cochran indicated that Ashley Carver completed the Incident Report, presumably to establish that ADON Cochran was not the one who contacted the physician.  P. Ex. 3 at 7.  In her own written statement, Ms. Carver makes no mention of notifying Dr. Brown on January 10, 2019, and instead stated there was no “need” or “reason” to call the physician under the circumstances.  P. Ex. 3 at 2.  However, Ms. Carver completed the Resident Incident Report, with a box completed stating that Dr. Brown had been notified, suggesting that Ms. Carver did notify the physician.  CMS Ex. 8 at 55.  It is not necessary to resolve this conflict since, as discussed below, even if there had been a call or text to Dr. Brown on January 10, 2019, any such call or text did not constitute the “consult” required by the regulation.   P. Closing Br. at 10 (internal citations omitted).  To be sure, a Resident Incident Report regarding the fall on January 10, 2019, lists Deandre A. Brown as the physician notified.  CMS Ex. 8 at 55.

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The form, however, does not report the time that this notification occurred.  The form also does not report whether or not Dr. Brown responded to the notification (either with date or time).  This manner of “notification” cannot be considered sufficient to satisfy the regulation’s requirement to “consult” with the physician. 

As the Board stated in River City Care Center:

[R]egarding the requirement in section 483.10(b)(11)(i)  This regulation was revised and redesignated as 42 C.F.R. § 483.10(g)(14)(i)(B) on October 4, 2016.  81 Fed. Reg. at 68,853. to “consult” with a physician, we agree with the ALJ that “it is clear from the language of the regulation and its history” that consultation involves “more than merely informing or notifying the physician.”  Consultation, said the ALJ, requires a dialogue with and a responsive directive from the resident’s physician as to what actions are needed; it is not enough to merely notify the physician of the resident's change in condition. Nor is it enough to leave just a message for the physician.  Also, the facility must provide the physician with all the information necessary to properly assess any changes to the resident’s condition and what course of action is necessary.  Failure to provide even one aspect of the change in a resident’s condition can significantly impact whether the physician has been properly consulted.

River City Care Ctr., DAB No. 2627 at 8 (2015) (quoting Magnolia Estates Skilled Care, DAB No. 2228 at 8-9 (2009) (internal citation omitted)).

Assuming that, in fact, someone had called or texted Dr. Brown on January 10, 2019, I find that any such contact would not meet the regulatory requirement that the facility “consult” with Resident #1’s physician.  There is simply no evidence that Dr. Brown responded to any such contact and there is no evidence of any information provided to Dr. Brown about Resident #1’s condition.  As a result, I find that Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(g)(14)(i)(B).

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

As noted above, Ennis Care Center was charged with a violation of 42 C.F.R. § 483.25.  The opening provision of that section of the regulations, which implements sections 1819(b)(2) (Medicare) and 1919(b)(2) (Medicaid) of the Social Security Act, states:

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Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .

42 C.F.R. § 483.25. 

The subsections of that regulation then set forth specific requirements relating to particular types of care, services, and resident needs.  Based on the legislative history and the implementing regulations, the Board has previously stated that the quality of care requirement is “based on the premise that the facility has (or can contract for) the expertise to first assess what each resident’s needs are (in order to attain or maintain the resident’s highest practicable functional level) and then to plan for and provide care and services to meet the goal.”  Spring Meadows Health Care Ctr., DAB No. 1966 at 11 (2005).  The regulation thus “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  Windsor Health Care Ctr., DAB No. 1902 at 16-17 (2003), aff’d sub nom. Windsor Health Ctr. v. Leavitt, 127 F. App'x 843 (6th Cir. 2005); see Woodstock Care Ctr., DAB No. 1726 at 25-30 (2000), aff’d sub nom. Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  As the Board has previously observed, the regulatory requirements “are designed to focus on evaluating actual facility performance in meeting the purposes of the program and to move away from simply imposing checklists of capacities and services that must be available.”  Koester Pavilion, DAB No. 1750 at 25-26 (2000) (citing Woodstock, DAB No. 1726 at 28-29).  The quality of care provision also implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality “since the regulations elsewhere require that the services provided or arranged by the facility must meet such standards.”  Spring Meadows, DAB No. 1966 at 11 (citing 42 C.F.R. §§ 483.25, 483.75). 

In this case, CMS has alleged that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 and cites the surveyor’s report that Petitioner did not assess or provide treatment for chest pain, nausea, shortness of breath, restlessness, anxiety, falls, and elevated heart rate.  CMS Ex. 5 at 15.  Petitioner argues that appropriate treatment and monitoring were provided for nausea, shortness of breath, isolated elevated pulse rate, anxiety, and falls.  P. Closing Br. at 17-18.

As in the previous discussion, I agree with Petitioner that there was no credible evidence of complaints of chest pain during the relevant period.  I also agree that the record documents treatment of the complaint of nausea with administration of Zofran, per protocol on January 10, 2019.  CMS Ex. 8 at 1.  However, after carefully considering the record, I find that, without testimony from the surveyor, the evidence establishes that

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Resident #1 did not receive overall treatment and care in accordance with professional standards of practice, the Care Plan, and her choices. 

The treatment provided to Resident #1 for elevated heart rate as of January 10, 2019, was not consistent with professional standards of practice.  As discussed earlier, Resident #1 had episodes of rapid heart rate in the past.  The Medication Record indicates many instances of elevated pulse rate since June 2018.  P. Ex. 9.  However, this ongoing problem was not specifically addressed in the Care Plan.  Hypertensive heart disease with heart failure was identified in the Care Plan as a problem, but there was no discussion of or interventions for rapid heart rate included.  P. Ex. 6.  Moreover, as of January 10, 2019, there was a change in the pattern of her pulse or heart rates.  As noted earlier, in the days immediately preceding January 10, 2019, Resident #1’s pulse rate was not significantly elevated.  During the period from January 6, 2019 through January 8, 2019, her pulse rates ranged from 70 to 97, all within the normal range.  P. Ex. 10 at 1.  At the time of the fall at 12:30 AM on January 6, 2019, pulse was recorded as 76 in the nursing note describing that incident.  CMS Ex. 8 at 3.  Vital signs recorded at the time of the fall at 2:06 AM on January 9, 2019, included a heart rate of 75.  CMS Ex. 8 at 2.  In the Resident Incident Report from the January 9, 2019 fall, pulse was also reported to be 75.  CMS Ex. 8 at 48.  During the subsequent monitoring following the fall on January 9, 2019, pulse rates were recorded as 75, 82, 82, 76, 74, 77, 76, 78, 79, 82, 105, 90, 77, and 82, with only one measurement above the normal range.  P. Ex. 10 at 3.  On January 10, 2019, however, pulse rates remained at an elevated level nearly constantly throughout the day.  After recording the pulse rate of 129 at the time of the fall at 9:00 PM, rates were measured during the subsequent monitoring at 93, 103, 104, 101, 99, 101, 101.  CMS Ex. 8 at 1; P. Ex. 10 at 4.  While Petitioner’s expert witness refers to the elevated heart rate of 129 on January 10, 2019, as an “isolated” reading which returned to normal within 15 minutes, the readings from that day clearly indicate that Resident #1’s heart rate remained at an elevated rate for most of the day.  P. Ex. 38 at 11.  Yet, there is no indication in the record that these persistently elevated readings were brought to the attention of the physician for assessment. 

The treatment provided to Resident #1 for shortness of breath as of January 10, 2019, was not consistent with professional standards of practice.  When admitted to Ennis Care Center on June 15, 2018, Resident #1 had a diagnosis of COPD.  CMS Ex. 8 at 5, 8.  This was also listed as a diagnosis on the discharge Face Sheet dated January 11, 2019.  CMS Ex. 8 at 32.  COPD was identified as a diagnosis in the Physician’s Orders for January 2019.  CMS Ex. 8 at 34.  This impairment was not, however, addressed in the Care Plan.  P. Ex. 6; CMS Ex. 8 at 14-28.  As discussed above, there was evidence that Resident #1 was experiencing shortness of breath on January 10, 2019 and January 11, 2019.  P. Ex. 3 at 1, 4.  As also discussed above, the fact that this was not a new complaint or finding is not relevant.  Nursing staff deemed the shortness of breath serious enough on those days

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to administer oxygen.  The only standing order in evidence for oxygen was from Dr. Brown, who authorized oxygen at 2 liters/MIN for O2 saturation levels of less than 90%.  P. Ex. 5 at 3.  However, as discussed above, there are no oxygen saturation levels recorded during the relevant time period.  As a result, I can only assume that Resident #1’s condition met this, or some other unidentified threshold, in order to administer the oxygen.   There were additional standing orders from Dr. Brown in situations involving shortness of breath.  He had provided an order for DUONEB per HHN (hand‑held nebulizer) every 6 hours for shortness of breath.  P. Ex. 8 at 2.  However, there is no evidence that this medication was administered to Resident #1 while she was experiencing shortness of breath severe enough to administer oxygen on January 10, 2019 and January 11, 2019 or any evidence that the need for administration of this medication was discussed with Dr. Brown.  CMS Ex. 8 at 72. 

The treatment provided to Resident #1 for falls as of January 10, 2019, was not consistent with professional standards of practice or the care plan.  The Care Plan identified a risk for falls with a history of episodes of attempting to self transfer without assistance.  The falls were characterized as unavoidable due to history of medication seeking and non‑compliance.  The interventions to address this problem were identified as continuing to educate resident on use of the call light for transfer assist, ensure a safe environment, adequate lighting, and cleaning spills promptly.  After falls in August 2018, October 2018, and November 2018, the intervention continued to be to educate the resident on the use of call light for transfer assist.  P. Ex. 6 at 6.  Even though the falls continued, the primary intervention was not changed or modified.  It is readily apparent that this intervention was not effective in stopping the falls and attempts at unassisted transfers.  Petitioner’s expert witness indicated that “it was clear that Resident #1 would not follow the staff’s instructions to call for help.”  P. Ex. 38 at 11.  The more appropriate question is whether she could follow the staff’s instructions to call for help.  As discussed above, Resident #1 was subject to mental impairments that resulted in impaired cognition, being forgetful, difficulty with realistic thoughts and goals, history of paranoia, recent history of suicide attempts, trouble concentrating, impulsivity and poor safety awareness.  P. Ex. 6 at 1; CMS Ex. 8 at 40, 67.  These residuals of the mental impairment could have interfered with her ability to comply with the instructions to seek assistance when transferring.  There is no evidence in this record to indicate that Petitioner recognized this intervention was not effective and sought to find an alternative.  Rather, Petitioner merely characterized the falls as “unavoidable” and continued with an ineffective intervention for several months.  P. Ex. 6 at 6.  To continue to use an inutile intervention that was not effective is not consistent with a level of treatment and care in accordance with professional standards of care. 

The treatment provided to Resident #1 for the bipolar disorder as of January 10, 2019 was not consistent with professional standards of practice or the care plan.  The Care Plan noted the January 6, 2019 fall and indicated that the resident refuses to call for assistance

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and becomes agitated with staff when they remind her to call.  The Care Plan also indicated Resident #1 was seen on January 8, 2019 by “senior psych” for a recent increase in behaviors, agitation, yelling out, and disproven accusations following recent medication reductions in the previous two months.  As noted above, although Petitioner asserts that Resident #1 was “seen two days before the incident in question by her physician who adjusted her medication in an attempt to alleviate her increased behaviors” (P. Closing Br. at 17-18), there are no treatment records from this reported visit in the record and there is no indication she was actually seen by a physician on that date.  To the contrary, the change in medication was apparently authorized by an RN, PMHNP, who issued a telephone order dated January 8, 2018 changing the Depakote prescription from BID to TID.  While the order reflects an order and signature date of January 8, 2018, the order also appears to have been signed by the nurse receiving the order on January 8, 2019.  P. Ex. 5 at 10. There is another discrepancy in the dates cited for the psychological consultation and associated medication change.  There is an entry in the Care Plan dated January 9, 2018, indicating Resident #1 “was seen on 1/8 by senior psych”.  P. Ex. 6 at 6.  However, the Care Plan also contains an entry dated January 9, 2019 indicating Resident #1 was seen by senior psych with a medication change on January 8, 2019.  P. Ex. 6 at 10.  Given the fact that nursing notes dated January 8, 2019 in CMS Ex. 8 at 2 refer to the medication change on that date, it is likely that the reference to 2018 was the result of the all too common problem of writing the wrong year in early January. It is not necessary to further pursue this since, even if there had been an earlier medication change on January 8, 2018, the record still documents a medication change on January 8, 2019.   P. Ex. 6 at 6, 10.  On January 9, 2019, medications were adjusted by increasing divalproex, which she reportedly received for seizure prevention, to TID from BID.  CMS Ex. 8 at 2.  However, there is no evidence of mental health or physician follow up after the medication change, even though Resident #1 displayed a dramatic increase in unassisted transfers and falls beginning January 9, 2019, including a recent attempt to throw herself out of bed.  P. Ex. 3 at 7.  The Care Plan included the need to review the effectiveness of the medication regimen at least quarterly or PRN.  P. Ex. 6 at 10-11.  Given the noted increase in problem behaviors after an earlier medication change, and the increase in falls and unassisted transfers after the medication change on January 8, 2019, the failure to assess Resident #1’s functioning or to contact her physician or mental health professional for guidance was not consistent with professional standards of care or the Care Plan. 

In light of the above failures to provide evaluation and care in the face of increased symptoms and behaviors beginning on January 10, 2019, I find that Petitioner was not in substantial compliance with the requirements of 42 C.F.R. § 483.25.  In reaching this conclusion, I have considered Petitioner’s argument that the Michigan Peer Review Organization (MPRO) concluded in the IDR process that there was no regulatory basis for the F580 citation.  P. Closing Br. at 16.  However, I have declined to give those

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conclusions any weight for the reasons discussed previously.  I am not bound by the conclusions reached by adjudicators at lower levels of the review process.  Moreover, the record that was before the MPRO is not the same record that is before me presently.  I must base my decision on the current record, which does not establish that Petitioner was in substantial compliance with the provisions of 42 C.F.R. § 483.25, for the reasons set forth above.

C.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1),(2).

42 C.F.R § 483.25(d)(1),(2) provides that as part of the quality of care a facility is expected to provide, a facility must ensure that -

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

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

CMS asserts that Petitioner was not in substantial compliance with the provisions of 42 C.F.R. § 483.25(d)(2) because it failed to adequately supervise Resident #3 to prevent his elopement from the facility.  CMS Opening Br. at 14.  Petitioner argues that it did what was reasonable to prevent the elopement and there is no evidence that more frequent monitoring would have prevented this occurrence.  Moreover, Petitioner alleges that the “accident” in question was the elopement, not the time it took to retrieve Resident #3 after he eloped.  P. Prehearing Br. at 19-20.  It finally argues that “the supervision provided to the resident in question (Resident #3) was appropriate and within the industry standards.”  P. Closing Br. at 18. 

The facts surrounding this incident are not in dispute.  Resident #3, a 62 year old male, was admitted to the facility on May 17, 2019.  CMS Ex. 10 at 1.  Active diagnoses at the time of admission included mild cognitive impairment, history of cerebral infarction (unspecified), hemiplegia affecting the right dominant side, aphasia, and hypertension.  CMS Ex. 10 at 19-20.  An Elopement/Wandering Risk Data Set dated May 18, 2019, indicated no history or risk of elopement.  CMS Ex. 10 at 4.  Resident #3 was placed on one‑hour monitoring for the first 72 hours at the facility, consistent with the facility’s Admission Protocols Process.  CMS Ex. 15 at 26; P. Ex. 16 at 1. 

On May 19, 2019, Resident #3 was observed by a staff person in his room at 2:00 PM.  CMS Ex. 10 at 33; P. Ex. 20 at 16.  He was then observed by a CNA in his room at 2:30 PM.  CMS Ex. 10 at 34; P. Ex. 20 at 15.  When a staff member visited his room at 3:00 PM to 3:15 PM to obtain his vital signs, he was not there.  CMS Ex. 10 at 36; P. Ex. 20 at 13.  He was again not in his room during rounds at 4:00 PM.  CMS Ex. 10 at 34; P. Ex.

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20 at 15.  The medication aide entered his room at 7:00 PM to pass his medication and observed he was not there and notified the charge nurse.  CMS Ex. 10 at 36; P. Ex. 20 at 13.  The charge nurse initiated a search for Resident #3 throughout the facility.  When he was not found, the Director of Nursing (DON) was notified, who then had the police notified.  CMS Ex. 10 at 44.  Resident #3 was subsequently located at a convenience store approximately 1.5 miles from the facility.  CMS Ex. 5 at 26.  He was taken by the police to his former home, which was the address he provided to the police.  CMS Ex. 10 at 2.  The DON picked him up and returned him to the facility, where he was assessed for injuries and placed on 15 minute monitoring.  CMS Ex. 10 at 14.  A Wanderguard was placed on his left ankle.  CMS Ex. 10 at 45. 

To provide a resident “adequate supervision” consistent with section 483.25(d)(2), a facility has flexibility to choose how to supervise a resident “as appropriate to [its] circumstances and to employ reasonably necessary measures to comply with the regulation,” but the measures chosen must be able to “reduce known or foreseeable accident risks to the highest practicable degree . . . .”  Heritage Plaza Nursing Ctr., DAB No. 2829, at 6, 20 (2017) (quoting Century Care of Crystal Coast, DAB No. 2076 at 6-7 (2007), Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 15 (2017)); see also Windsor, DAB No. 1902 at 5 (supervision or other accident-prevention measures taken must be “‘adequate’ level of supervision under all the circumstances”); Del Rosa Villa, DAB No. 2458 at 18 (2012) (whether a facility complied with section 483.25(h)(2)  This regulation was redesignated as 42 C.F.R. § 483.25(d) on October 4, 2016.  81 Fed. Reg. at 68,860.  depends on whether it took all reasonable and practicable measures to identify, evaluate, and reduce or eliminate the foreseeable risk of an accident), aff'd, Del Rosa Villa v. Sebelius, 546 F. App'x 666 (9th Cir. 2013); Libertywood Nursing Ctr., DAB No. 2433 at 7 (2011) (“ensuring” adequate supervision involves identifying and minimizing safety risks), aff'd, Libertywood Nursing Ctr. v. Sebelius, 512 F. App'x 285 (4th Cir. 2013); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 21 (2004) (section 483.25(h)(2) requires facility to eliminate or reduce known or foreseeable “risk of accident to the greatest degree practicable”), aff'd, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App'x 900 (6th Cir. 2005).

A facility's obligations under section 483.25 also includes furnishing the care and services set forth in its own resident care policies.  Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012), aff'd, Life Care Ctr. of Bardstown v. Sec’y of U.S. Dep’t of Health & Human Servs., 535 F.App'x 468 (6th Cir. 2013); Life Care Ctr. of Tullahoma, DAB No. 2304 at 34 (2010) (care and services required by section 483.25 include those called for by “established facility policies”), aff'd, Life Care Ctr. Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs., 453 F.App'x 610 (6th Cir. 2011); Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018) (section 483.25 obligates a SNF to follow its own resident care policies).  Indeed, “[o]nce a facility adopts a policy that incorporates

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the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents, [the] facility is held to follow through on them.”  Heritage Plaza, DAB No. 2829 at 20. 

In this case, the facility’s own protocols require hourly monitoring for the first 72 hours in the facility “for proper care and risk of changes in condition related to facility admission.”  CMS Ex. 15 at 26; P. Ex. 16 at 1.  Forms in the record indicate that hourly monitoring was, in fact, completed.  CMS Ex. 10 at 5-7.  In the form dated May 19, 2019, lines were drawn from 0600 through 2200, with the notation “OK” and the initials of MH.  CMS Ex. 10 at 7.  However, since Resident #3 was known to be missing from the facility since approximately 3:00 PM on that date, it is readily apparent that the form was not an accurate summary of actual events.  Moreover, statements from the involved staff establish that hourly monitoring was not provided on May 19, 2019.  Mary Hicks, the RN completing the form, indicated in a written statement that she observed Resident #3 in his room at approximately 2:00 PM.  She did not indicate any other observations of him on that date in her written statements until he was returned to the facility after the elopement.  P. Ex. 20 at 4-7.  In a nursing note, she indicated she was informed at approximately 7:30 PM that Resident #3 was missing and initiated a search.  CMS Ex. 10 at 44.   There is no evidence that any other staff person was providing the hourly monitoring.  Thus, there is no evidence to establish that Resident #3 received the hourly monitoring he was to receive under the facility’s own protocols. 

Petitioner essentially concedes that the hourly monitoring did not occur.  Instead, Petitioner argues that the supervision provided to Resident #3 was “appropriate and within the industry standards.”  P. Closing Br. at 18.  Petitioner previously argued that there is no regulatory requirement for hourly monitoring and it is unfair to hold Petitioner to a one‑hour monitoring schedule when other facilities could choose to implement a two hour monitoring schedule.  P. Prehearing Br. at 16-17.  Petitioner is entirely correct that the regulations do not specifically require hourly monitoring of new residents.  I would also accept the argument that other facilities may have a policy of monitoring new residents every two hours, although the relevance of that argument to the issue before me is not clear.  No evidence on “industry standards” for resident monitoring was submitted for the record.    However, it is disingenuous to institute a policy for monitoring new residents and then complain that it is not fair to be held to such a policy.  As the Board has noted: 

Section 483.25(h) “does not prescribe any specific accident‑prevention method.”  Lifehouse of Riverside Healthcare Ctr., DAB No. 2774, at 15 (2017).  Rather, “facilities have flexibility to choose the specific methods as appropriate to their circumstances and to employ reasonably

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necessary measures to comply with the regulation.”  Id.  (citations omitted). Once a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents, however, the facility is held to follow through on them.  Id.  Moreover, the Board has stated, “The fact that the regulations do not specify that a particular type of care is necessary to meet a requirement does not prevent a finding of noncompliance when the facility itself has determined that type of care is necessary.”  Id., citing Azalea Court, DAB No. 2352, at 9.

Heritage Plaza, DAB No. 2829 at 20. 

Petitioner then asserts that the “accident” to be prevented is not the time away from the facility after the elopement but the elopement itself, which the facility did what was reasonable to prevent.  Petitioner alleges that checking on Resident #3 hourly would not have stopped the elopement and that, even with hourly checking, he could have eloped between monitoring.  Petitioner argues that after staff saw Resident #3 at 2:30, if he eloped at 2:40 or 2:45, checking on him at 3:00 or 3:30 would not have stopped the elopement.  P. Prehearing Br. at 19-20.  Such an argument presumes that there was no incremental risk to Resident #3 the longer he was outside of the facility.  While it is certainly plausible that Resident #3 could have eloped between the hourly checks, conducting the required hourly monitoring and checking on him at 3:00 or 3:30 would certainly have resulted in a search for him significantly earlier and would not have resulted in an elderly confused individual being out of the facility for four to five hours with the associated inherent risks.  The facility’s own definition of elopement recognized this risk, defining elopement as “the ability of a resident who is not capable of protecting himself or herself from harm to successfully leave the facility unsupervised and unnoticed and who may enter into harms way.”  CMS Ex. 15 at 36 (emphasis added).  The failure to conduct the hourly checks resulted in Resident #3 being in “harms way” for over four hours. 

Finally, Petitioner cites 42 C.F.R. § 483.75(o)  This regulation was redesignated as 42 C.F.R. § 483.75(i) on October 4, 2016.  81 Fed. Reg. at 68,868.  for the argument that CMS inappropriately cited a deficiency based on information in the facility’s Quality Assurance (QA) documents and on issues that the facility’s QA Committee had already definitively and properly addressed.  P. Prehearing Br. at 18.  42 C.F.R. § 483.75(i) does provide that good faith attempts by a QA committee to identify and correct quality deficiencies will not be used as a basis for sanctions.  However, Petitioner’s claim on this issue is without merit, because it has not demonstrated the surveyor relied on information

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produced by its QA Committee to identify the deficiency at issue.  The facility’s own procedures provide that QA documents will be marked “Committee Privileged.”  CMS Ex. 15 at 35.  There is no indication that any of the documents in the record bear this designation.  Petitioner does not even claim the surveyor requested that the facility disclose any QA records for review that would have led the surveyors to discover that hourly monitoring had not been done.  Instead, the record shows the surveyor learned of the elopement through required incident reports.  The fact that an incident report is also reviewed by the QA committee does not make it a privileged document.  The drafters of the regulation cited by Petitioner specifically addressed the facility’s argument:

We [CMS] also retain the proposed requirement that “Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanction.”  This requirement is not new; however, it now also includes QAPI [Quality Assurance and Performance Improvement] activities. As is currently the case, surveyors are instructed not to cite as a deficiency for a requirement other than the QAPI requirements a concern that would not have been identified but for a review of QAPI materials for the purpose of determining compliance with the QAPI regulations.  That said, nothing in this section would preclude a surveyor from citing a concern that is identified based on a review of materials or on observations separate and apart from an assessment of QAPI compliance.  Excluding such a concern simply and only because it has also been identified by the QAPI program would be irresponsible of CMS.

81 Fed. Reg. at 68,806 (emphasis added); see also Jewish Home of E. Pa., DAB No. 2254 at 6 n.3 (2009) (regulations establishing disclosure and use restrictions for QA Committee records do not establish an evidentiary privilege or rule of evidence).

In this case, Petitioner conducted an investigation of the elopement, presumably in accordance with 42 C.F.R. § 483.12(c).  CMS Ex. 10 at 2, 32-36.  With respect to documents generated in such investigations, the Board has stated: 

Such documents may well also become the basis for review, consideration, analysis and action by a QA Committee, which could result in the creation of QA Committee records, but we see no basis to treat such raw factual material as itself the product of the QA Committee process,  Such material is more analogous to actual patient care records, such as nursing notes or progress reports, which may well be important for the QA Committee to evaluate in determining the underlying causes

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of or best approaches to address a facility issue identified by the QA Committee.  But this material clearly does not thereby become QA Committee records, unavailable for the purposes for which it was actually created (i.e., medical care of the patient or management of an incident). 

Jewish Home, DAB No. 2254 at 11. 

For the above reasons, I see no basis for excluding from consideration any documents under the use and disclosure restrictions of 42 C.F.R. § 483.75(i). 

In concluding that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1),(2), I have considered the opinion of Petitioner’s expert witness that “there was no deficient practice with respect to Resident #3 and, even if there had been, any deficiency was corrected by the facility’s QA Committee prior to the survey” so “that under 42 [C.F.R. §] 483.75(o),  As noted previously, the regulation cited by the expert witness was redesignated as 42 C.F.R. § 483.75(i) on October 4, 2016.  81 Fed. Reg. at 68,868.  no deficiency should have been cited.”  P. Ex. 38 at 13.  However, I have not given this opinion on the ultimate issue here any weight because the evidence, set forth above, clearly establishes the regulatory violation and the inapplicability of 42 C.F.R. § 483.75(i). 

D.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.50(a)(2)(ii). 

CMS asserts that Petitioner failed to meet the regulatory requirements of 42 C.F.R. § 483.50(a)(2)(i),(ii) because it did not promptly notify the physician of laboratory results that fell outside of clinical reference range on October 5, 2018.  CMS argues that the document relied on by Petitioner to demonstrate the required physician notification is “highly suspicious” because it is dated October 25, 2018.  In addition, CMS alleges that the physician assistant told the surveyor that he did not receive the laboratory results until October 6, 2018.  CMS Opening Br. at 17-19.  Petitioner responds that “(c)ontrary to the surveyor’s allegations, Nurse Foster immediately notified the physician of the critical lab value, and no new orders were received.”  P. Closing Br. at 19 (internal citation omitted). 

I have reviewed the record and the parties’ contentions.  I am unable to find evidence to support that Petitioner was not in substantial compliance with 42 C.F.R. § 483.50(a)(2)(i), as referenced in the Statement of Deficiencies (SOD).  CMS Ex. 5 at 39.  While CMS includes the citation of subsection (i) in its brief (CMS Opening Br. at 17), it makes no argument and cites no evidence supporting a deficiency under this subsection.  I therefore make no finding concerning a deficiency under subsection

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42 C.F.R. § 483.50(a)(2)(i), but, as discussed below, find that CMS has established a deficiency under 42 C.F.R. § 483.50(a)(2)(ii). 

Resident #2 was a 59 year old woman who was readmitted to the facility on September 20, 2018 with diagnoses including unstageable ulcers of the sacral region, left heel and ankle, and other sites, myasthenia gravis, end stage renal disease, muscle wasting and atrophy, sepsis, and anemia.  CMS Ex. 9 at 1-2.  On October 5, 2018, labs were drawn at 5:45 AM and results were reported at 9:43 AM.  CMS Ex. 9 at 34; P. Ex. 34.  Results included a while blood cell (WBC) count of 29.50, which was in the critical range.  According to the written laboratory report, at 9:35 AM, the “[c]ritical result [was] called and faxed to BEATRICE, LVN.  Results read back correctly.”  CMS Ex. 9 at 34; P. Ex. 34 at 2. 

Under 42 C.F.R. § 483.50(a)(2)(ii), the facility must “[p]romptly notify the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist of laboratory results that fall outside of clinical reference ranges, in accordance with facility policies and procedures for notification of a practitioner or per the ordering physician’s orders.”  There is no dispute in this case that the WBC value on October 5, 2018, was in the range requiring notification.  The question here is whether the facility promptly notified the physician of this value in accordance with facility policies and procedures for notification of a practitioner. 

CMS argues that the facility’s policy was to immediately inform the resident and consult with the resident’s physician upon a significant change in the physical, mental, or psychosocial status of a resident, and the critical lab values constituted a significant change in Resident #2’s condition.  CMS then alleges that the facility ignored the “consultation” requirement in its own policy.  CMS Opening Br. at 18 (citing CMS Ex. 15 at 33).  CMS’s focus on the “consultation” requirement is misplaced, however.  The portion of the facility policy cited by CMS addresses situations involving an acute change of condition, which is governed by 42 C.F.R. § 483.10(g)(14)(i)(B).  While the critical lab value may have resulted in a significant change in the resident’s physical condition, CMS did not cite Petitioner with a violation of that regulation, nor did it produce evidence to establish there was a significant change in the resident’s condition.  As a result, holding Petitioner to that standard and requiring a “consultation” with a physician, with the associated procedures discussed earlier, is not appropriate. 

The facility did have written policies for physician notification.  The Policy for Physician Notification/Protocol Usage required the nurse to “contact physician at any time that the timeliness and urgency of the resident needs change.”  CMS Ex. 15 at 27 (emphasis added).  The facility also had a written policy for a change in condition, requiring the physician to be “notified of all changes in condition and incidents . . . .”  CMS Ex. 15 at 33‑34 (emphasis added).  So, the question becomes whether there is evidence that the facility failed to promptly notify the physician of the critical lab value.

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In resolving this question, I note that the Board has held that CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.  If CMS makes this prima facie showing, then the SNF must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. 98-3789 (GEB) (D. N.J. May 13, 1999); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F.App’x 664 (6th Cir. 2005); Guardian Health Care Ctr., DAB No. 1943 (2004); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home, Inc. v. U.S. Dep't of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).

CMS makes a prima facie showing of noncompliance if the evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal.  Hillman Rehab. Ctr., DAB No. 1663 at 8 (1998), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. 98-3789 (GEB) (D. N.J. May 13, 1999).  A facility can overcome CMS’s prima facie case either by rebutting the evidence upon which that case rests or by proving facts that affirmatively show substantial compliance.  Tri-Cty. Extended Care Ctr., DAB No. 1936 (2004).  “An effective rebuttal of CMS’s prima facie case would mean that at the close of the evidence the provider had shown that the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence.”  Tri-Cty., DAB No. 1936 at 4 (quoting Western Care Mgmt. Corp., DAB No. 1921 (2004)).

In making a case for a prima facie showing of noncompliance, CMS points to the handwritten notation on the lab report dated October 25, 2018 as “highly suspicious” and proof “that the critical laboratory values were not promptly forwarded to the physician.” CMS further asserts that “the physician assistant stated that he did not receive the laboratory results until October 6, 2018.”  CMS Opening Br. at 18-19 (citing CMS Ex. 5 at 42).  Petitioner alleges that Nurse Foster did immediately notify the physician of the critical lab value and “documented her notification on the face of the lab sheet . . . .”  Petitioner also indicates that “Nurse Shahara (Shay) Dunbar likewise confirmed that she heard Nurse Foster on the phone relaying the critical lab information to the physician/PA” and “Dr. Brown even stated that his office was notified of the critical lab results.”  P. Closing Br. at 19 (citing P. Exs. 4, 34, 36). 

In considering the evidence on the issue of prompt notification, it is first necessary to evaluate the physician assistant’s statement that he did not receive the critical lab results until October 6, 2018, which is reportedly based on an interview with him by the

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surveyor.  CMS Ex. 5 at 42.  This, of course, is hearsay.  Hearsay statements are admissible in a proceeding such as this, even if they are inadmissible under the rules of evidence applicable to court proceedings.  42 C.F.R. § 498.61.  In addition, hearsay statements may constitute substantial evidence of noncompliance if they have sufficient indicia of reliability.  Pac. Regency Arvin, DAB No. 1823 at 14 n.6 (2002); Richardson v. Perales, 402 U.S. 389, 402 (1971).  A number of factors may be considered in evaluating the reliability of a hearsay statement, including, without limitation, whether:  (1) the hearsay declarant is biased and has an interest in the result of the case; (2) the opposing party has the means to obtain the information contained in the statement and to verify its accuracy; (3) the opposing party can subpoena the declarant; (4) the statement is corroborated or contradicted by other evidence; (5) the statement is consistent with other statements made by the declarant; (6) the statement is signed or sworn to; and (7) the declarant is available to testify.  Richardson v. Perales, 402 U.S. at 402-06.

In assessing the reliability of the hearsay statement of the physician’s assistant, in CMS Ex. 5 at 42, there are some factors which reduce its reliability.  The physician assistant himself provided a statement in which he indicated that he gave a general opinion in response to the surveyor’s questions, because he did not have access to patient medical records at the time of their conversation.  He did not specifically make any reference in that statement to notification of the critical lab values.  P. Ex. 37.  As a result, P. Ex. 37 does not corroborate the statements from the surveyor in CMS Ex. 5 at 42.  An additional concerning factor is the fact that Petitioner is not able to cross-examine the surveyor because her declaration was withdrawn by CMS.

However, facility records provide some corroboration of the physician assistant’s statement regarding the timing of the notification.  In a report by Sharon Wolfe, RN, RAC-CT, CDP, in response to a grievance  The grievance was based on complaints of failure to change PICC lines and dressings, which are not relevant to the issue before me of physician notification of lab values.  CMS Ex. 9 at 69.   filed by Resident #2’s daughter, Nurse Wolfe indicated that earlier in the morning of October 6, 2018, “Nina Mitchell, LVN had dealt with critical lab results and notified Jennifer Andrade, LVN, ADON and she told them to send to ER.  Ada Bakare, PA was notified and he agreed his order was to send to ER.  He had not been notified earlier.”  CMS Ex. 9 at 82 (emphasis added).  Ms. Wolfe’s statement was somewhat corroborated by the statement from Nina Mitchell, LVN, who indicated that on October 6, 2018, at approximately 1:00 AM, Resident #2 “was having difficulty swallowing, and she was refusing food and medication.  I notified the doctor, and when I notified him, I also reminded him of a critical lab value that had been received earlier in the day (although the lab slip itself indicates the physician had already been notified of the critical finding).”  P. Ex. 26 at 1.  While the notation on the lab slip is discussed below, the timing of the events described by Ms. Mitchell are consistent with the timing of the events described by Ms. Wolfe.  The timing of the events set forth in the

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statements from facility staff are completely consistent with the statement from the surveyor, who indicated that during an interview on June 19, 2019, the physician assistant “said he did not receive notification of Resident #2’s critical laboratory value until 10/6/19 at approximately 2:00 a.m..”  CMS Ex. 5 at 42.  As a result, I find the statement from the physician assistant regarding the date and time of the notification of the critical lab value contained in CMS Ex. 5 at 42 to be reliable evidence constituting prima facie evidence of noncompliance, since notification many hours after lab results were received cannot be considered prompt notification. 

The burden of proof then shifts to Petitioner to rebut the evidence upon which the noncompliance allegation rests or by proving facts that affirmatively show substantial compliance.  Petitioner essentially makes three arguments to establish that prompt notification of the critical lab value occurred.  Petitioner alleges that Nurse Foster did immediately notify the physician of the critical lab value and also “documented her notification on the face of the lab sheet . . . .”  Petitioner also asserts that Nurse Shahara (Shay) Dunbar “likewise confirmed that she heard Nurse Foster on the phone relaying the critical lab information to the physician/PA” and that “Dr. Brown even stated that his office was notified of the critical lab . . . .”  P. Closing Br. at 19 (citing P. Exs. 4, 34-36). 

I do not find the statements from Nurse Dunbar and Dr. Brown to be “confirmation” that there was prompt notification of the critical lab value provided to the physician.  Contrary to the argument from Petitioner that Nurse Dunbar “confirmed that she heard Nurse Foster on the phone relaying the critical lab information to the Physician/PA” (P. Closing Br. at 19), the statement from Nurse Dunbar did no such thing.  The statement from Nurse Dunbar in an Incident Witness Statement was “[h]eard critical labs called overhead but did not take call on resident.”  P. Ex. 36.  Unless Petitioner is somehow asserting that the call to the physician was made over the loudspeaker, this statement does not provide any support for prompt notification of the physician.  Similarly, Dr. Brown’s statement does not reflect any first-hand information regarding the notification and certainly does not support a finding that his office received prompt notification of the critical lab value.  He merely indicates that the “critical lab was called to my PA Ada Bakera according to the documentation.  The 24 hours that was between the lab and the hospital trip would not make a difference in her death.”  Ironically, Dr. Brown also added a statement that “[d]ocumented means it was completed.”  P. Ex. 4 at 2.  He apparently was unaware of the grievance investigation cited above, in which the facility concluded that “Bea Foster, LVN was the nurse on 10/4/18 and 10/5/18.  She said she did not do the PICC line because she forgot but she signed out she did it.”  CMS Ex. 9 at 82.   P. Ex. 4 at 1 (emphasis added).  What Dr. Brown does not indicate is when the critical lab was called to his PA.  Moreover, Dr. Brown does not identify the “documentation” to which he refers.  If his statement was offered as evidence that the critical lab value was communicated to his office sometime after it was received by the facility on October 5, 2018 at 9:35 AM, it certainly does not corroborate

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that Dr. Brown or his physician assistant had seen the critical lab value and responded to it. 

What remains is the lab report itself.  Petitioner points to P. Ex. 34 as evidence that Nurse Foster did immediately notify the physician of the critical lab value and “documented her notification on the face of the lab sheet.”  P. Closing Br. at 19 (citing P. Ex. 34).  P. Ex. 34 is a copy of the lab report from CMMS Lab Services, containing the WBC value of 29.50, which the lab characterizes as a critical result.  P. Ex. 34 at 2.  Page 1 of that lab report contains the notation “10/5/18 PA ade notified. B. Foster Lvn.”  P. Ex. 34 at 1; see also CMS Ex. 9 at 42.  However, Page 2 of that lab report, which is the page containing the WBC levels, contains the notation “10/25/18 PA ade notified. B. Foster.”  P. Ex. 34 at 2; CMS Ex. 9 at 34.

The reason for the different dates is unexplained.  Petitioner cites the IDR reviewer’s decision and states that “[t]he date of 10/25/18 was considered a mis-writing because Page 1 is consistent with receipt of the report and the resident was no longer present in the facility on 10/25/18.”  P. Closing Br. at 22.  What the IDR reviewer does not note is that in addition to Resident #2 no longer being present in the facility because of her death, Nurse Foster was also no longer in the facility as of October 25, 2018.  As noted earlier, a grievance investigation regarding changing of PICC (peripherally inserted central catheter) lines and dressings resulted in a report that Nurse Foster had completed documentation indicating that she had done work she forgot to do.  Nurse Foster was suspended pending investigation of this incident, but instead resigned.  CMS Ex. 9 at 82.  While there is no direct evidence that she falsified the particular documents referenced above, this history does not add great reliability to any document she signed.  Finally, even assuming that Nurse Foster did notify the physician of the critical lab value on October 5, 2018, the lack of any indication of the time that this was done precludes a finding that any such notification was done “promptly.” 

I conclude that Petitioner has failed to rebut the evidence upon which the noncompliance allegation rests and has not proven facts that affirmatively show substantial compliance.  In so doing, I have considered but not given weight to the opinions of the IDR reviewers.  As discussed above, the record before them is not identical to that before me.  As a result, I find that Petitioner was not in substantial compliance with the requirements of 42 C.F.R. § 483.50(a)(2)(ii).

E.  CMS failed to make a prima facie showing that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1),(2). 

CMS asserts that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1),(2) because facility staff failed to use proper sterilization techniques while changing Resident #9’s PICC line dressing.  CMS Opening Br. at 19-20.  Petitioner responds by arguing that because there is no surveyor testimony or other eye witness

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testimony to corroborate this allegation, CMS cannot establish a regulatory violation.  Oddly, Petitioner describes the incident on which the F880 violation was based as a nurse aide failing to change gloves between perineal care for two different residents.  P. Closing Br. at 22.   Petitioner further alleges that there is no evidence that it failed to develop and implement an overall infection control program, which is the focus of the cited regulation.  P. Closing Br. at 22. 

Petitioner is correct that the cited provisions of 42 C.F.R. § 483.80(a) address the requirement “to develop and implement an overall infection control program.”  P. Closing Br. at 22.  The regulation requires the facility to establish and maintain an infection control program that includes both an infection prevention and control program and written standards, policies, and procedures for the program.  Petitioner is also correct that CMS has not cited any evidence to support a finding that Petitioner failed to develop and implement an overall infection control program.  To the contrary, CMS submitted facility policies, which included evidence of written procedures for the insertion and changing of IV needles and equipment, catheters, and PICC lines for infection control.  CMS Ex. 15 at 4-25.  Thus, there is no apparent evidence of a systemic failure to establish and maintain an infection control program with written standards on the part of the facility.

Instead, CMS asserts that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1),(2) because a nurse did not use proper sterilization techniques while changing Resident #9’s PICC line dressing on June 19, 2019.  CMS Opening Br. at 19; CMS Ex. 5 at 50.  While not directly expressed, CMS appears to argue that the facility somehow did not enforce or effectuate its infection prevention and control program.  CMS cites as sole support for this assertion CMS Ex. 5 at 50, which is a reported observation by the surveyor of a PICC line dressing change by a nurse on June 19, 2019.  CMS Opening Br. at 20.  The question for resolution is whether, with this evidence, CMS has made a prima facie showing that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1),(2). 

In resolving this question, I again refer to the Board’s holdings on the burden of proof.  As discussed in detail above, CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.  CMS makes a prima facie showing of noncompliance if the evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal.  Hillman, DAB No. 1663 at 8. 

In this case, the evidence cited by CMS to establish a prima facie case is the SOD and, specifically, the written observations of the surveyor of a PICC line dressing change and

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reported interviews with the LVN who conducted the dressing change, and with the DON.  CMS Ex. 5 at 50-51.  The Board has held that a “SOD is a contemporaneous record of the survey agency's observations and investigative findings, and [CMS] may make a prima facie showing of noncompliance based on that document if the factual findings and allegations it contains are specific, undisputed, and not inherently unreliable.”  Guardian, DAB No. 1943 at 14 (citing Glenburn Home, DAB No. 1806 at 25 (2002)); Universal Health Care-King, DAB No. 2383 at 9 (2011).  The question here then becomes whether the statements in the SOD are specific, undisputed, and not inherently unreliable. 

Petitioner asserts that the F880 citation under review is based on an unsupported allegation with no surveyor testimony and no testimony from any eyewitness on this issue.  P. Closing Br. at 22.  While, as noted above, Petitioner cited a different alleged observed violation than that cited in the SOD, I read Petitioner’s arguments as an objection to the purported noncompliance.  In its prehearing exchange and at the prehearing conference, Petitioner requested to cross-examine CMS’s proposed witnesses, including the surveyor, Robin Allen, RN.  As detailed in the procedural history, CMS subsequently withdrew the Declaration of Robin Allen, R.N., contained in the record as CMS Ex. 17.  The withdrawal of that declaration by CMS resulted in the Petitioner being unable to cross-examine the surveyor regarding the observations she reported in the SOD.  I do not find those statements, standing alone, to be reliable evidence on which to base an alleged deficiency, given the inability here to challenge the accuracy of those statements through cross examination, as Petitioner indicated its intention to do. 

In addition, the surveyor’s reported interviews with the LVN who performed the PICC line dressing change and the DON are hearsay.  As discussed above, hearsay statements may constitute substantial evidence of noncompliance if they have sufficient indicia of reliability.  Pac. Regency Arvin, DAB No. 1823 at 14 n.6; Richardson v. Perales, 402 U.S. at 402.  In assessing the reliability of the surveyor’s allegations in the SOD regarding the PICC line dressing change, I note that her statements were not corroborated by other evidence, the SOD was not signed or sworn, the only sworn document was withdrawn and did not even address this deficiency, and the surveyor was not available to testify.  Richardson v. Perales, 402 U.S. at 402-06.  Given these factors, I do not find the unsupported observations of the surveyor in the SOD to be reliable evidence sufficient to establish a prima facie case of noncompliance with a regulatory requirement. 

F.  Because Petitioner was in substantial compliance with Medicare participation requirements under 42 C.F.R. § 483.80(a)(1),(2), CMS lacked a basis to impose a CMP for Tag F880.

CMS imposed a CMP of $20,220.00 per instance for the deficiency F880 and 42 C.F.R. § 483.80(a)(1),(2).  CMS Ex. 3 at 1; CMS Ex. 4 at 1.  For the reasons discussed above, I have found that CMS failed to establish that Petitioner was not in substantial

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compliance with the provisions of 42 C.F.R. § 483.80(a)(1),(2).  As a result, there is no basis for imposition of that CMP. 

G.  The penalties for the supported violations are reasonable.

Petitioner argues that I should also review the level of noncompliance found by CMS, asserting that the scope and severity should be reduced to no higher than a level D.  However, Petitioner then correctly recognizes that I “may not be able to directly address scope and severity since only per-instance (as opposed to per-day) penalties are in play.”  P. Closing Br. at 23.  As noted by Petitioner, an ALJ may review CMS’s scope and severity findings, which include a finding of immediate jeopardy, only if a successful challenge would affect the range of the CMP assessed or if CMS has made 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), (d)(10); Evergreen Commons, DAB No. 2175 at 2 (2008); Aase Haugen Homes, Inc., DAB No. 2013 (2006).  As cited above, the penalties imposed here are per instance CMPs, for which the regulations provide only one range ($2,140 to $21,393).  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2019); 83 Fed. Reg. 51,369, 51,370 (Oct. 11, 2018).  This is in contrast to a per day CMP, which, by regulation, consists of two ranges of penalties, an upper range and a lower range.  42 C.F.R. § 488.438(a)(1).  Because CMS imposed per instance CMPs, a successful challenge to CMS’s immediate jeopardy finding would not affect the range of the CMP imposed.  NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014), appeal dismissed, NMS Healthcare of Hagerstown, LLC v. U.S. Dep’t of Health & Human Servs., 619 F.App’x 225 (4th Cir. 2015).  Nor does CMS’s scope and severity finding affect approval of a nurse aide training program.  There is no evidence that Petitioner had a nurse aide training program.  However, even if Petitioner had a nurse aide training program, when a facility has been assessed a CMP of $5,000 or more, as has occurred here, the state agency may not approve its nurse aide training program.  42 C.F.R. § 483.151(b)(2)(iv).  For these reasons, I conclude that I have no authority to review CMS’s finding of immediate jeopardy.

As held above, CMS has established that Petitioner was not in substantial compliance with the provisions of the following:

• 42 C.F.R. § 483.10(g)(14)(i)(B) (F580);
• 42 C.F.R. § 483.25 (F684);
• 42 C.F.R. § 483.25(d)(1),(2) (F689); and
• 42 C.F.R. § 483.50(a)(2)(ii) (F773).

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The penalties assessed by CMS for those violations were $20,220.00, $20,220.00, $10,515.00, and $20,220.00, respectively.  CMS Ex. 3 at 1.

In deciding whether the CMP amounts are reasonable, I may consider only the factors specified in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3); Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703 at 12 (2016).  Those factors are:  (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.  42 C.F.R. § 488.438(f).  The factors in 42 C.F.R. § 488.404, in turn, 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.  In addition, the Board has held that “there is a presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS.”  Coquina Ctr., DAB No. 1860 at 32 (2002); Brenham Nursing & Rehab. Ctr., DAB No. 2619 at 18 (2015), aff'd, Brenham Nursing & Rehab. Ctr. v. U.S. Dept. of Health & Human Servs., 637 F.App'x 820 (5th Cir. 2016).  “Accordingly, the burden is not on CMS to present evidence bearing on each regulatory factor, but on the SNF to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 26 (2011); Brenham, DAB No. 2619 at 18 (SNF has burden to introduce evidence or argument regarding the regulatory factors); Crawford Healthcare & Rehab., DAB No. 2738 at 19 (2016). 

Petitioner’s brief cites only one regulatory factor, the seriousness of the violations, and argues for CMP reduction because the IDR reviewers determined that the violation of F684, if true, did not constitute immediate jeopardy noncompliance.  Petitioner then asserts that CMS assigning per‑instance values was “nonsensical,” “haphazard,” and without “testimony to establish what CMS did and why,” and the penalty should therefore be reduced.  P. Closing Br. at 24.  As noted above, the Board has held that the CMP amount selected by CMS is presumptively reasonable and based on consideration of the regulatory factors listed above and that the burden is on the facility “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, DAB No. 2738 at 19.  Citing the IDR’s conclusion regarding the appropriateness of the immediate jeopardy citation is not evidence relating to any of the regulatory factors.  Moreover, as discussed above, I have no authority to review CMS’s findings of immediate jeopardy, regardless of what the IDR might have determined. 

Petitioner did reference the seriousness of the noncompliance as a factor to consider in determining the reasonableness of the CMP, but provides no argument beyond the IDR’s

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conclusions.  I have considered this factor in the context of the four instances of noncompliance found in this case.  Of the three residents involved, two died and one was left to wander outside the facility for over four hours with the associated risks to an elderly and confused individual.  Given these outcomes, I find it difficult to entertain an argument that the noncompliance found was not serious in these cases. 

As a result, I find that the penalties of $20,220.00 imposed for noncompliance with 42 C.F.R. § 483.10(g)(14)(i)(B) (F580), $20,220.00 imposed for noncompliance with 42 C.F.R. § 483.25 (F684), $10,515.00 imposed for noncompliance with 42 C.F.R. § 483.25(d)(1),(2) (F689), and $20,220.00 imposed for noncompliance with 42 C.F.R. § 483.50(a)(2)(ii) (F773) are reasonable. 

III.  Conclusion

I find that Petitioner was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.10(g)(14)(i)(B), 483.25, 483.25(d)(1),(2), and 483.50(a)(2)(ii).  The per instance civil money penalties are reasonable.