Epic Nursing & Rehabilitation, CR5984 (2021)

DECISION

Epic Nursing & Rehabilitation (Petitioner or “the facility”) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirements regarding quality of care (42 C.F.R. § 483.25), pharmaceutical services (42 C.F.R. § 483.45(a)), and administration (42 C.F.R. § 483.70), and that its noncompliance resulted in immediate jeopardy to the health and safety of its residents, when it allowed the 11-year child of an employee to provide care to its residents.  Petitioner challenges the per-day civil monetary penalty (CMP) of $12,930 that was imposed from July 7 through 14, 2019, and the per-day CMP of $110 that was imposed from July 15-16, 2019.  I find that there is no dispute as to any material fact, and CMS is entitled to judgment as a matter of law.  The per-day CMPs imposed are reasonable enforcement remedies.  However, because CMS determined that Petitioner abated immediate jeopardy on July 14, 2019, I affirm a per-day CMP of $12,930 from July 7-13, 2019, and a per-day CMP of $110 from July 14-16, 2019.

I.  Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human

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Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, an SNF must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i-3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  CMS may impose a per-day CMP for the number of days an SNF is not in substantial compliance, or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).1

If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

Surveyors from the Texas Health and Human Services Commission (state agency) completed a complaint investigation survey at Petitioner’s facility on July 16, 2019, and cited immediate jeopardy noncompliance2 with the following three Medicare program participation requirements at the “K” level scope and severity:3  42 C.F.R. §§ 483.25

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(cited as Tag F684, Quality of Care), 483.45(a), (b)(1)-(3)4 (cited as Tag F755, Pharmacy Services/Procedures/Pharmacist/Records), and 483.70 (cited as Tag F835, Administration).  CMS Ex. 1; see CMS Ex. 6 at 1.  The statement of deficiencies reported that Petitioner abated immediate jeopardy on July 14, 2019, but remained out of substantial compliance at the conclusion of the survey.  CMS Ex. 1 at 2, 28, 35.

In a letter dated August 5, 2019, CMS informed Petitioner that it concurred with the state agency’s findings of substantial noncompliance with Medicare program participation requirements.  CMS Ex. 2 at 1.  CMS determined that immediate jeopardy had been abated, but that Petitioner remained out of substantial compliance.  CMS Ex. 2 at 1.  CMS imposed enforcement remedies that included a per-day CMP of $12,930 for eight days of immediate jeopardy noncompliance from July 7 through 14, 2019, and a $110 per-day CMP thereafter beginning on July 15, 2019.  CMS Ex. 2 at 2.  On October 7, 2019, CMS informed Petitioner that it had returned to substantial compliance on July 17, 2019.  CMS Ex. 3 at 1.  CMS re-affirmed the per-day CMP of $12,930 that it had imposed for eight days, from July 7 through 14, 2019, and informed Petitioner that a per-day CMP of $110 had been imposed for two days from July 15-16, 2019.  CMS Ex. 3 at 1.  

Petitioner timely requested a hearing on October 3, 2019.  CMS filed a combined pre-hearing brief and motion for summary judgment, along with 13 proposed exhibits (CMS Exs. 1-13), and Petitioner filed a brief and response to CMS’s motion for summary judgment, and nine proposed exhibits (P. Exs. 1‑9).  The parties submitted the written direct testimony of several witnesses (CMS Exs. 12 and 13,5 and P. Exs. 1-6).  Standing Pre-Hearing Order, § 11.  In the absence of any objections, I admit all proposed exhibits into the evidentiary record.

II.  Issues

The issues presented are:

Whether summary judgment is appropriate;

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Whether Petitioner was in substantial compliance with 42 C.F.R. §§ 483.25, 483.45(a), and 483.70;

If Petitioner was not in substantial compliance, whether the deficiencies posed immediate jeopardy to resident health and safety;

Whether the enforcement remedies of a per-day CMP of $12,930 from July 7-14, 2019, and a per-day CMP of $110 from July 15-16, 2019, are reasonable.

III.  Discussion6

1.  Summary judgment is appropriate because material facts are not in dispute.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  Senior Rehab. & Skilled Nursing Ctr.,DAB No. 2300 at 19-20 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs.,405 F. App’x 820 (5th Cir. 2010); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).  The moving party must show that there are no genuine disputes of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Anderson,477 U.S. at 248.  If the moving party meets its initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’”  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (emphasis omitted).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab., DAB No. 2300 at 3.  In determining whether there are genuine issues of material fact for hearing, an ALJ must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  Id.

It is well established that an ALJ is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 (5th Cir. 2019) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010) (“All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”) (emphasis added); Crestview Parke Care Ctr., 146 F.3d 425, 428-29 (6th Cir. 2004) (explaining that [t]he statute authorizing the imposition

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of penalties requires a hearing ‘on the record,’ and that the use of summary judgment is “valid” and “provides an alternative to in-person, oral hearings.”).

The material facts establishing Petitioner’s noncompliance with 42 C.F.R. §§ 483.25, 483.45(a), (b)(1)-(3), and 483.70 are not disputed.  One of Petitioner’s nurses repeatedly brought her 11-year-old child to the facility.  While at the facility during her mother’s shifts, the child performed such tasks as crushing residents’ medications in preparation for administration, answering call lights, and serving ice water to residents.  The child was also allowed to be present in Resident # 1’s room on separate occasions during a medical emergency and a medical procedure.  Moreover, even though Petitioner’s Director of Nurses (DON) and administrator both learned of the report that the child was crushing and passing medications on July 10, 2019, neither manager took additional action after the DON telephonically requested that the nurse remove her child from the facility.  Rather, the child returned to the facility the following day, at which time she worked alongside her mother during the night shift.  The DON and administrator learned from the survey team, on July 13, 2019, that the child had returned to the facility on July 11, 2019.  Although Petitioner disputes both the findings of substantial noncompliance and immediate jeopardy to resident health and safety, it does not dispute the aforementioned facts.  There is no genuine dispute as to any material fact that requires a hearing, and summary judgment in CMS’s favor is warranted.

2.  Petitioner does not dispute that one of its nurses brought her 11-year-old child to work at the facility for shifts on July 7, 8, 10 and 11, 2019.

3.  Petitioner does not dispute that the child crushed residents’ medications and mixed the medications with food.

4.  Petitioner does not dispute that the child responded to call lights and brought ice water to residents who lived on its 100 and 400 halls.

5.  Undisputed evidence shows that one resident in Hall 100 had a physician order directing that he not consume food or drink by mouth, and that two residents in Hall 400 had physician orders for nectar-thickened liquids.

6.  Petitioner concedes that the residents with liquid consistency restrictions on the units where the child served ice water in response to call light requests were “incapable of drinking water themselves.”

7.  Petitioner does not dispute that the child was present in Resident # 1’s room while emergency medical services (EMS) personnel tended to Resident # 1 during a suspected stroke; in fact, it submitted the testimony of a certified nursing assistant (CNA) who “witnessed the

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daughter in Resident # 1’s room while paramedics were attending to the resident.”

8.  Petitioner does not dispute that, on July 10, 2019, a CNA sent a text message to the administrator, along with a photograph, in which she reported that “the nurse is allowing her 11 year old daughter to crush and pass meds on 400 hall.”

9.  Petitioner does not dispute that the child returned with her mother to the facility on July 11, 2019, at which time she responded to residents’ call lights.

10.  Petitioner does not dispute that the child was present in Resident # 1’s room during a procedure to insert a peripheral central catheter (PICC) during the overnight hours of July 11, 2019.

11.  Petitioner’s administrator testified that, until notified during the survey on July 13, 2019, she was unaware that the child had returned to the facility for the night shift on July 11, 2019.

12.  Petitioner submitted a plan of removal for immediate jeopardy on July 14, 2019, that was accepted by the surveyors that same day.

Petitioner concedes material facts at issue in its factual presentation of the case. 

Petitioner offered the following statement of facts, under the heading, “Daughter’s Actions in the Facility”:

[C.S.]7 , [a licensed vocational nurse at the facility], brought her daughter to work with her on July 10, 2019.  (CMS Ex. 12, p. 4.)  [C.S.] trained her daughter on how to crush medications and controlled her daughter’s access to medications (CMS Ex. 11, p. 21; CMS Ex. 12, p. 5; Pet. Ex. 1, p. 2).  [C.S.] had the key to the medication cart and supervised her daughter’s actions.  (Pet. Ex. 1, p. 2).  The daughter pushed the medication cart and medications to [C.S.] to be passed to residents.  (CMS Ex. 12, p. 4).  [C.S.] did not allow her daughter to pass the medications to residents, (CMS Ex. 12, p. 5) other than when the daughter, at the instruction of her mother, handed a cup of Icy Hot salve to [a resident].  (CMS Ex. 11, p. 21).

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[C.S.] allowed her daughter to observe paramedics providing care to a resident.  (CMS Ex. 12, p. 4).  The daughter stood in the corner of the room during the care.  (Pet. Ex. 3, p. 1).  [C.S.] allowed her daughter to observe a PICC line insertion while the daughter sat out of the way of the procedure.  (CMS Ex. 12, pp. 4-5).

The daughter answered call lights and passed ice water to some residents.  (CMS Ex. 12, pp. 4, 7, 15).  No residents with liquid consistency restrictions were given ice water or were capable of drinking water themselves.  (Pet. Ex. 1, p. 2). 

P. Br. at 8-9.  Under a separate heading, “Management’s Response,” Petitioner presented additional facts:

On July 10, 2019 . . . [the CNA] . . . sent a text to . . . the facility administrator, that said, “please call me at your earliest convenience.”  (CMS Ex. 11, p. 31).  [The administrator] responded, and [the CNA] told [the administrator] that [C.S.’s] daughter was crushing and passing medications.  (Pet. Ex. 2, p. 1).  [The administrator] immediately called . . . the [DON] and informed her of the situation. (P. Ex. 1, p. 1.)  [The DON] immediately called [C.S.] and instructed her that the daughter was not to do anything with the medication cart and that her daughter was not allowed at the Facility with her while she was working.  Id.  The daughter was to wait in the break room or a common area until [C.S.] could take her home on her break.  Id.

P. Br. at 9.  Petitioner made the following additional factual statements in its brief:

Based on [the DON’s] previous experience with [C.S.], she had no reason to believe that [C.S.] would not comply with her directive.  Id.  Based on [the DON’s] experience with the daughter, she believed that the daughter would not act outside the instructions of her mother or act in a manner that would put any resident at risk.  Id.  [The DON] also took into consideration her knowledge that [the CNA], who reported the situation to [the administrator], did not like working with [C.S.] and could not have fully witnessed the events in question because she worked on a different hall.  Id.

P. Br. at 11-12.

Petitioner submitted the written testimony of six witnesses, to include three staff members (P. Exs. 1-3) and three residents (P. Exs. 4-6).

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The DON testified that she met the child when she volunteered at a holiday event at the facility.  P. Ex. 1 at 1.  The DON determined that, based on this encounter, the child was “nice, quiet, and helpful and seemed conscientious of the residents’ needs.”  P. Ex. 1 at 1. The DON testified that she called C.S. on July 10, 2019, and “instructed her that the daughter was not to do anything with the medication cart and that her daughter was not allowed at the facility with her while she was working.”  P. Ex. 1 at 1.  The DON explained that “[n]o one reported to [her] that [C.S.] brought her daughter with her again for her night shift on July 11, 2019,” and she “was not aware that the daughter had returned to the facility with [C.S.] on July 11, 2019.”  P. Ex. 1 at 2.  The DON reported that she “did not take further action on the matter between calling [C.S.] on July 10, 2019 and the surveyor’s notifications on July 13, 2019, because [she] believed [she] had resolved any issues with [C.S.] on July 10, 2019.”  P. Ex. 1 at 2.  The DON explained that “in considering the CNA’s report, [she] was aware that [the CNA] did not like working with [C.S.], which would make her more likely to make a negative report.”  P. Ex. 1 at 2.  The DON also stated that because the CNA worked on a different hall, she “would not have been able to fully witness the events in question in order to make an accurate report.”  P. Ex. 1 at 2.  Addressing the child’s service of ice water to residents, the DON stated the following:

There was no risk associated with the daughter passing out ice water because no residents with liquid consistency restrictions were given ice water, and even if they had been given water, they were all incapable of drinking the water themselves.

P. Ex. 1 at 2.  The DON reported that “[t]here were no known delays in any treatment or lack of treatment provided as a result of the daughter answering call lights.”  P.  Ex. 1 at 2.

The administrator also provided written direct testimony.  P. Ex. 2.  The administrator explained that she received a text message from the CNA on July 10, 2019, informing her that C.S. “brought her daughter to work with her that night and that the daughter was crushing and passing medications.”  P. Ex. 2 at 1.  She testified that the DON “[took] care of it” by “instructing [C.S.] to take her daughter home and not bring her back to the facility while [she] was working.”  P. Ex. 2 at 1.  The administrator testified that “[n]o one reported to [her], and [she] was not aware, that [C.S.] brought her daughter with her again for her night shift on July 11, 2019.”  P. Ex. 2 at 1.  The administrator reported that she “did not take further action on the matter between calling [the DON] on July 10, 2019 and the surveyor’s notifications on July 13, 2019, because [she] believed any issues with [C.S.] had been resolved by [the DON] on July 10, 2019.  P. Ex. 2 at 1.  Like the DON, the administrator stated: 

There was no risk associated with the daughter passing out ice water because no residents with liquid consistency restrictions were given ice

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water, and even if they had been given water, they were all incapable of drinking the water themselves.

P. Ex. 2 at 2.  The administrator, as did the DON, reported that “[t]here were no known delays in any treatment or lack of treatment provided as a result of the daughter answering call lights.”  P.  Ex. 2 at 2.

Petitioner submitted the written testimony of a CNA who “was present in the facility when [C.S.] brought her daughter to work with her at the facility on July 7, 2019,” and “[i]n [his] opinion, the daughter’s presence or actions in the facility did not put any residents at risk of harm.”  P. Ex. 3.  This individual testified that he “witnessed the daughter in Resident # 1’s room while paramedics were attending to the resident.”  P. Ex. 3.  He further testified that he “saw the daughter taking ice water to a resident.”  P. Ex. 3.

Petitioner submitted the testimony of three residents.  P. Exs. 4-6.  Resident # 5 testified that she “saw the daughter crushing medications,” and that the mother was “watching over her and was by the child.”  P. Ex. 4.  Resident # 2 and Resident # 3 testified that the child answered their call lights.  P. Exs. 4, 6.  The three residents collectively testified that the child’s presence did not pose a “risk of harm” to residents.  P. Exs. 4-6.  

Petitioner does not dispute certain facts presented by CMS as undisputed facts

CMS, in its statement of undisputed material facts, reported that the following facts are undisputed.  Petitioner did not dispute any of the following facts, nor did it offer evidence to dispute the following facts presented by CMS:

• “[C.S.] brought her 11-year old child (child) with her to work at Epic on July 7, July 8, July 10, and July 11, 2019.  CMS Ex. 12, p. 4.  CMS Ex. 1, p. 36.”  CMS Br. at 4; see P. Br. at 8-9 (citing to CMS Ex. 12 at 4).
• “While at Epic on July 10, 2019, the unsupervised child crushed medications, added the crushed medications to cups of pudding with residents’ names on them, and then placed the cups on top of the medication cart.  CMS Ex. 12, p. 4, 6; CMS Ex. 11, p. 6.”[8 ]; see P. Br. at 8-9, 12.
• “Resident # 5 . . . observed the child crushing and mixing medications and placing the cups on top of the medication cart at the nurses’ station.  CMS Ex. 12, p. 4, 6.”

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• “On July 7, 2019, while paramedics were responding to a medical emergency involving [Resident # 1][9 ] having a stroke in her room, the child let the paramedics in one door of the facility and then accompanied the paramedics to [Resident # 1’s] room while they rendered care.  CMS Ex. 12, p. 4; CMS Ex. 11, p. 5.”
• “[O]n July 11, 2019, the child sat on the foot of [Resident # 1’s] bed while the Intravenous Technician inserted a peripheral, central catheter (PICC) line into her body.  CMS Ex. 12, p. 4-5.”
• “The child answered residents’ call lights in Hall 100 and 400.  CMS Ex. 12, p. 4-7; CMS Ex. 11, p. 6.”
• “[The child] delivered ice water to residents on Hall 100 and 400, including at least [Resident # 3].  CMS Ex. 12, p. 7, 15.  Two residents on Hall 400 had physician orders for thickened liquids because they could not have liquids of a regular consistency, and one resident on Hall 100 had a physician’s order that said the resident could not consume food or drink by mouth.  CMS Ex. 12, p. 7.”10
• [The CNA] saw the child crushing medications on July 10, 2019, and took a picture of the child pushing the medication cart.  CMS Ex. 12, p. 5.  At approximately 7:30 p.m. on July 10, 2019, [the CNA] sent the picture as a text message to the Administrator . . . notifying her that [C.S.’s] child was crushing

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and passing medications on Hall 400.  CMS Ex. 12, p. 5.  [The Administrator] forwarded the text message to the DON . . . .  Neither [DON] nor [the administrator] investigated the child’s access to the medication cart or the passing of medications that night or on July 11, 2019.  CMS Ex. 12, p. 5.”

• On July 11, 2019, [C.S.’s] child again accompanied her to work and was responding to residents’ call lights, passing ice water, and observing medical procedures.  CMS Ex. 12, p. 5, 6.  Epic began investigating the incidents on July 13, 2019.  CMS Ex. 12, p. 6.”

CMS Br. at 4-6.
 
Petitioner’s policies 

Petitioner has a medication administration policy that directs that “[o]nly persons licensed or permitted by this state to prepare, administer and document the administration of medications may do so.”  CMS Ex. 11 at 64.  Section 242.606 of the Texas Health and Safety Code states that “[a] person may not administer medication to a resident unless the person . . . holds a license under state law that authorizes the person to administer medication; or holds a permit issued under Section 242.610 . . . and acts under the authority of a person who holds a license under state law that authorizes the person to administer medication.” 

Petitioner’s medication administration policy also states that the DON “will supervise and direct all nursing personnel who administer medications and/or have related functions.”  CMS Ex. 11 at 64.  The policy requires an individual administering medications to verify the resident’s identity through one of several listed methods.  CMS Ex. 11 at 64.  Addressing the safety of the medication cart, the policy directs that “[n]o medications are kept on top of the cart,” “[t]he cart must be clearly visible to the personnel administering medications, and all outward sides must be inaccessible to residents or others passing by.”  CMS Ex. 11 at 65.

During the survey, on July 15, 2019, Petitioner implemented a policy that “no child under the age of 16 is allowed to stay at the facility while the staff member is on duty,” and that an employee’s child “may come to the facility with a sitter or family member but may not stay the entire shift.”11   CMS Ex. 11 at 60.

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13.  By allowing a child to respond to call lights, crush and mix medications, and be present during both a medical emergency and a medical procedure, Petitioner did not ensure that it provided the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of its residents, as required by 42 C.F.R. § 483.25.

14.  Petitioner has not demonstrated that CMS’s determination that the noncompliance with section 483.25 amounted to immediate jeopardy to resident health and safety is clearly erroneous.

Discussion

Pursuant to 42 C.F.R. § 483.25, “[b]ased on the comprehensive assessment of a resident, [a] 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.”  The Departmental Appeals Board (DAB) has determined that CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.”  The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008).  The DAB “has long held that a facility’s own policy may be sufficient evidence both of professional standards of quality and of what the facility has determined is needed to meet the quality of care requirements.”  Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013). 

Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).

Pursuant to Petitioner’s own policy and state law, “[o]nly persons licensed or permitted” by Texas to “prepare, administer and document the administration of medications may do so.”  CMS Ex. 11 at 64; Tex. Health and Safety Code § 242.606.  Nonetheless, Petitioner allowed an 11-year-old child who was not licensed by the State of Texas to crush residents’ medications and place those medications in pudding cups for administration to residents.  Regardless of whether the child passed the medications to residents, which is

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disputed by Petitioner,12 the child was tasked with preparing resident medications for administration.  Such a task is contrary to Petitioner’s policy that, on its face, would preclude an unlicensed child from preparing and administering medications.  CMS Ex. 11 at 64.  In fact, and consistent with Petitioner’s policy incorporating Texas requirements, licensed nursing personnel would be responsible for such a task that would expectedly require a degree of attention that may not be commensurate with the abilities of a child assisting on the night shift.  See CMS Ex. 11 at 64 (Petitioner’s policy, stating: “The individual administering the medication must check the label THREE (3) times to verify the right resident, right medication, right dosage, right time and right method (route) of administration before giving the medication.”).  By allowing a child, and not a licensed professional, to prepare medications for administration, Petitioner failed to provide treatment and care in accordance with professional standards of practice. 

Petitioner also allowed the child to answer call lights for residents in its 100 and 400 halls.  And Petitioner allowed the child, in response to call light requests, to deliver ice water to those residents.  See P. Ex. 3 (testimony that the child delivered ice water on July 7, 2019); P. Br. at 9 (“The daughter answered call lights and passed ice water to some residents.”).  Petitioner does not claim, nor does any evidence suggest, that the child checked resident care plans and current orders, or consulted the nursing staff, prior to serving residents ice water.13  Although the DON and administrator claim that the child did not serve ice water to any residents with liquid consistency restrictions (P. Exs. 1 at 2; 2 at 2),14 it appears that, assuming this is true, this was simply the result of good fortune.  Inasmuch as Resident # 10 and Resident # 11 had orders for nectar-thickened liquids, and Resident # 13 could not consume any food or drink by mouth, none of these three

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residents could safely consume ice water, particularly without supervision.15   CMS Ex. 11 at 42, 46, 48; see CMS Exs. 1 at 11, 27-28, 43-44; 4.  The DON and administrator both acknowledged that these residents “were all incapable of drinking the water themselves.”  P. Exs. 1 at 2; 2 at 2.  By allowing a child who lacked nursing skills and competence, access to physician orders, and knowledge of residents’ care plans to respond to resident call lights, Petitioner exposed its residents to a significant risk of harm. 

Petitioner also permitted the child to violate a resident’s privacy.  On July 7, 2019, the child was present when EMS personnel tended to Resident # 1, who was suspected of having a stroke, at which time she was “slumped over, drooling,” and “unable to follow commands.”  CMS Ex. 7 at 8.  Likewise, even though a PICC line insertion, which includes sterile and anesthetic preparation, is a medical procedure, Petitioner allowed the child to deny Resident # 1 her privacy during the procedure.  See CMS Exs. 1 at 22-24; 12 at 4-5.  Both the state agency and CMS expressed concerns about the child’s infringement of Resident # 1’s privacy (CMS Ex. 1 at 15; CMS Br. at 5), yet Petitioner is silent on this issue.  See P. Br at 9 (Petitioner’s concession that the child was present during the PICC line insertion procedure, without any discussion of the medical emergency or the concerns raised about Resident # 1’s privacy).  Notably, it appears that Resident # 1 may have been incapable of consenting to the child’s presence.  See CMS Ex. 7 at 5 (reporting a BIMS score of 4, indicating severe cognitive impairment); 8 (reporting that during the suspected stroke, Resident # 1 was slumped over and unable to follow commands); 18 (reporting that Resident # 1 had “difficulty making [her]self understood”).  By allowing a child to be present in a resident’s room during a medical emergency and a medical procedure, Petitioner failed to ensure that its care and treatment maintained Resident # 1’s highest practicable physical, mental, and psychosocial well-being.  See CMS Ex. 11 at 36 (immediate jeopardy plan of removal reporting that DON and administrator “were inserviced” on issues that included “HIPPA [sic].”); 42 C.F.R. § 483.25.

Petitioner has made no showing that CMS’s determination that the deficiency posed immediate jeopardy to resident health and safety is clearly erroneous.16   Notably, even after the administrator received a report that the child had been allowed to “crush and pass meds” (CMS Ex. 11 at 30), the child was able to return to the facility for the July 11,

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2019 night shift, at which time she responded to call lights and passed ice water, among other activities.  Although Petitioner argues against the immediate jeopardy citation, it fails to explain how allowing a child to crush medications, in preparation for their administration to residents, did not place residents in peril; the result of an error by the unlicensed 11-year-old child would be a resident (or residents) receiving the incorrect medication.17   Likewise, although Petitioner makes the troubling claim that the residents on 400 Hall who had liquid consistency restrictions were not exposed to a risk of harm because those residents “were all incapable of drinking the water by themselves,” the exact opposite is true:  if a resident with fluid restrictions is incapable of drinking water by himself or herself, then providing ice water to that resident, who may attempt to drink the water by himself or herself, places that resident at risk for serious harm from aspiration or choking.  Petitioner undoubtedly exposed its residents to a significant risk of serious harm when it allowed an unlicensed 11-year-old child to prepare medications for administration, respond to call lights, and serve ice water on the 100 and 400 halls, and Petitioner has not shown the immediate jeopardy determination is clearly erroneous.

15.  By allowing an unlicensed child to crush and mix medications, Petitioner did not ensure that that it accurately dispensed and administered medications to meet the needs of each resident, as required by 42 C.F.R. § 483.45(a). 

16.  Petitioner has not demonstrated that CMS’s determination that the noncompliance with section 483.45(a) amounted to immediate jeopardy to resident health and safety is clearly erroneous.

Not only did Petitioner fail to ensure that residents received care in accordance with professional standards of practice, but it exposed its residents to a risk of significant harm from a medication error.  Pursuant to 42 C.F.R. § 483.45, a facility “may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.”  Further, a facility “must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.”  42 C.F.R. § 483.45(a).  As previously discussed, the State of Texas requires that an individual who administers medication to a resident be licensed or permitted in accordance with state law.  Tex. Health and Safety Code § 242.606.

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Petitioner does not dispute CMS’s claim that the child crushed and mixed medications; in fact, Petitioner’s brief is silent regarding CMS’s allegation that the child mixed the crushed medications with pudding labeled for individual residents.  See CMS Br. at 4.  By allowing the child to crush and mix medications, Petitioner assumed that the child would correctly place each crushed medication in the corresponding cup for the resident to whom the medication would be administered.  Petitioner does not argue that C.S. closely supervised the child while she mixed the crushed medications with food and placed the medications in cups.  See P. Br. at 15 (“[A resident] . . . witnessed the daughter crushing the medications but indicated that the mother was always nearby.”); P. Ex. 4 (testimony of Resident # 5 that the mother was “watching over her and was by the child when she was crushing the medications,” but not addressing the child’s mixing of the crushed medications into pudding cups).  Petitioner administered these medications to residents, and by allowing an unlicensed and untrained child to prepare medications for administration, Petitioner exposed its residents to a risk of a significant medication error.  Such disregard for the safe medication administration for its residents, much less compliance with its own policy and state law, undoubtedly caused immediate jeopardy to resident health and safety. Petitioner has not demonstrated that the immediate jeopardy determination is clearly erroneous.

17.  Even after Petitioner’s administrator was notified by the CNA that the child had crushed and passed medications on July 10, 2019, the child was allowed to return to the facility for the night shift on July 11, 2019, at which time she responded to call lights, delivered ice water, and observed a medical procedure in Resident # 1’s room; Petitioner failed to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as required by 42 C.F.R. § 483.70.

18.  Petitioner has not demonstrated that CMS’s determination that the noncompliance with section 483.70 amounted to immediate jeopardy to resident health and safety is clearly erroneous.

Pursuant to 42 C.F.R. § 483.70, a facility must be governed in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.  A finding of substantial noncompliance in the facility’s administration may derive from findings of substantial noncompliance in other areas, and based on other immediate jeopardy conditions, a facility may not comply with 42 C.F.R. § 483.70.  The DAB has explained: 

[W]here a facility has been shown to be so out of compliance with program requirements that its residents have been placed in immediate jeopardy, the facility was not administered in a manner that used its resources effectively

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to attain the highest practicable physical, mental, and psychosocial well-being of each resident. 

Asbury Ctr. at Johnson City, DAB No. 1815 at 11 (2002); see Stone County Nursing & Rehab. Ctr., DAB No. 2276 at 15-16 (2009). 

Astoundingly, Petitioner was in receipt of contemporaneous photographic evidence that “the nurse is allowing her 11 year old daughter to crush and pass meds on 400 hall.”  CMS Ex. 11 at 30.  Rather than physically reporting to the facility to provide on-site direction and supervision, the DON telephonically directed C.S. to remove her child from the facility and assumed she would “comply with [her] instructions.”  See  P. Ex. 1 at 2 (testimony of DON that she “believed [she] had resolved any issues with [C.S.] on July 10, 2019”).  However, neither the DON nor the administrator followed up to ensure that C.S. removed her child from the facility, nor did the DON and administrator investigate the allegation that the child had been “crushing and passing medications.”18   See P. Exs. 1 at 1; 2 at 1.  Further, neither the DON nor the administrator followed up to make sure C.S.’s child did not return to the facility.  See P. Exs. 1, 2.

Petitioner determined it had “resolved” the situation by telephonically asking the nurse to remove her daughter from the facility.  Petitioner did not conduct an on-site investigation to interview residents or other staff members, but rather, dismissed the CNA’s report that the child was “crushing and passing medications” based on a belief that the reporting CNA “did not like working with [C.S.], which would make her more likely to make a negative report.”  P. Ex. 1 at 2.  Thus, even when faced with contemporaneous photographic evidence that the child may be crushing and passing medications, Petitioner was dismissive of the serious allegation.

The administrator testified that “[n]o one reported to [her], and [she] was not aware, that [C.S.] brought her daughter with her again for her night shift on July 11, 2019.”  P. Ex. 2 at 1.  The DON similarly testified that “[n]o one reported to [her] that [C.S.] brought her daughter with her again for her night shift on July 11, 2019.”  P. Ex. 1 at 2.  It should come as no surprise that after the DON and administrator declined to take any meaningful action after a CNA reported that a child was crushing and passing medications, that no other staff member came forward to make a similar report.19

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Petitioner’s failures can directly be attributed to administrative failures.  The facility’s administration had been informed that a child had been crushing and passing medications in the facility, yet it took no meaningful action to either investigate the allegation or to ensure that such a situation could not happen again.20   Petitioner’s administration allowed the immediate jeopardy situation to continue, and the situation may have been addressed only because the surveyors identified the serious situation to Petitioner’s administration.  The facility was not administered in a manner that used its resources effectively to attain the highest physical, mental, and psychosocial well-being of its residents, in contravention of 42 C.F.R. § 483.70.  Petitioner has made showing that the determination of immediate jeopardy is clearly erroneous.

Finally, to the extent Petitioner complains that the three immediate jeopardy deficiencies are “stacked” and are based on the same set of facts, I note that undisputed facts separately establish noncompliance at the immediate jeopardy level with each Medicare participation requirement addressed herein.  Petitioner allowed a child to place residents at serious risk of harm, continued to allow the child to place residents at serious risk of harm, and failed to comply with separate Medicare participation requirements involving quality of care, medication administration, and administration of the facility.

19.  CMS determined that Petitioner abated immediate jeopardy on July 14, 2019.

20.  Because Petitioner abated immediate jeopardy on July 14, 2019, the period of immediate jeopardy noncompliance is from July 7-13, 2019.

Inasmuch as CMS determined that Petitioner removed immediate jeopardy on July 14, 2019, the terminal date of immediate jeopardy is one day earlier, on July 13, 2019.  See CMS Exs. 1 at 2, 17, 35 (statement of deficiencies determinations that immediate jeopardy was removed for each deficiency on July 14, 2019); 2 at 1 (CMS’s concurrence with the state agency’s findings); see, e.g., 42 U.S.C. § 1395i-3(h)(2)(b)(ii) (authorizing the imposition of CMPs for each day of noncompliance); see also CMS Pub. 100-7 (State Operations Manual) § 7522 (“The per day civil money penalty accrues for the number of days of noncompliance from the date that the deficiency starts until the date that the facility achieves substantial compliance . . . .”).  Because CMS determined that Petitioner abated immediate jeopardy on July 14, 2019, the duration of immediate jeopardy noncompliance is from July 7-13, 2019.

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21.  A per-day CMP of $12,930 is a reasonable enforcement remedy for the immediate jeopardy noncompliance from July 7-13, 2019.

22.  A per-day CMP of $110 is a reasonable enforcement remedy for the substantial compliance from July 14-16, 2019. 

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, to include a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, an ALJ must sustain the CMP.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The DAB has explained that “[i]t is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is de novo.”  Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 19 (2017).  I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors.

I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  The DAB has explained that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010), aff’d, Cedar Lake Nursing Home, 619 F.3d at 457.  

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.  42 C.F.R. §§ 488.408; 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, as adjusted annually under 45 C.F.R. part 102, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  The lower range of CMP, $50 to $3,000 per day, as adjusted annually under 45 C.F.R. part 102, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  In assessing the reasonableness of a

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CMP amount, an ALJ looks at the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC,DAB No. 2186 at 28 (2008).  Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404(a)-(c).  See, e.g., Senior Rehab.,DAB No. 2300 at 19-20.  In this case, CMS imposed a per-day CMP of $12,930 for immediate jeopardy noncompliance, which I have determined was from July 7-13, 2019, and a per-day CMP of $110 for the period of substantial noncompliance that was not immediate jeopardy, which I have determined was from July 14-16, 2019.  The per-day CMP of $12,930 is in the middle of the $6,525 to $21,393 range for penalties imposed for deficiencies constituting immediate jeopardy.  Specifically, a $12,930 CMP is approximately $1,000 lower than the midpoint of that CMP range.  The per-day CMP of $110 is at the very low end of the $107 to $6,417 range for penalties imposed for non-immediate jeopardy level deficiencies, at less than 1 percent of the allowable CMP.  42 C.F.R. §§ 488.408(d)(1)(iii), (e)(1)(iii); 488.438(a)(1)(i), (ii); 45 C.F.R. § 102.3 (2018).

The per-day CMP of $12,930 is entirely reasonable.  Petitioner has considerable culpability and the deficiency was serious; the undisputed facts show that a child was allowed to work alongside her mother for several shifts, during which time she prepared medications for administration to residents, responded to call lights, and passed out ice water to those residents who asked for it.  Further, the child disregarded the privacy of a resident during both a medical emergency and a medical procedure.  See 42 C.F.R. § 488.438(f)(4).  And even when Petitioner’s administration became aware of the child’s presence and activities in the facility, the child was nonetheless allowed to return with her mother for the night shift the following day. 

Other than arguing that a penalty in the “upper range” for CMPs is unreasonable based its flawed belief that none of the deficiencies posed immediate jeopardy, Petitioner does not offer any regulatory basis in support of its claim that a per-day CMP of $12,930 in the middle range of the allowable CMP is unreasonable.  I conclude that a per-day CMP of $12,930 for the reduced period of immediate jeopardy noncompliance, and under the egregious circumstances presented here, is reasonable for even a single immediate jeopardy deficiency. 

Petitioner has not offered any basis to dispute the near-minimum per-day CMP of $110 for the non-immediate jeopardy noncompliance.  The per-day CMP of $110 is reasonable.  See 42 C.F.R. § 488.438(f).  

IV.  Conclusion

For the reasons discussed above, I grant summary judgment in favor of CMS.  There is no genuine dispute of material facts, and I find that the facility was not in substantial compliance with the Medicare participation requirements.  A per-day CMP of $12,930

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for immediate jeopardy noncompliance, from July 7-13, 2019, and a per-day CMP of $110 for non-immediate jeopardy noncompliance, from July 14-16, 2019, are reasonable enforcement remedies.

1. The per-day CMP ranges applicable to this case are $6,525 to $21,393 for immediate jeopardy-level deficiencies and $107 to $6,417 for deficiencies that do not constitute immediate jeopardy.  42 C.F.R. § 102.3 (2018).  The aforementioned CMP ranges reflect statutorily mandated amounts and ranges as adjusted for inflation pursuant to the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No. 114-74, § 701; see 83 Fed. Reg. at 51,369-70, 51,380 (Oct. 11, 2018).
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2. Immediate jeopardy exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.
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3. Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.3.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 63, effective November 16, 2018); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “K” indicates a pattern of immediate jeopardy to resident health or safety.
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4. Because CMS limits its discussion to the participation requirement at 42 C.F.R. § 483.45(a), I do not address other subsections of this regulation.  See CMS Br. at 10.
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5. I do not rely on the testimony of CMS’s witnesses.  Rather, I largely rely on the facts presented by Petitioner (which internally reference the testimony of CMS’s witnesses), undisputed facts presented by CMS, and the testimony of Petitioner’s witnesses.
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6. Findings of fact and conclusions of law are in bold and italics.
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7. I have redacted the name of the nurse who brought her child to the facility, along with the name of the CNA who notified the administrator that the child was crushing and passing medications.  I refer to the nurse by her initials, C.S., and I refer to the CNA as “the CNA.”
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8. Petitioner did not dispute, much less address, the allegation that the child mixed the crushed medications with the labeled cups of pudding.  See P. Br.
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9. A July 1, 2019 minimum data set assessed that Resident # 1 had a Brief Interview for Mental Status (BIMS) summary score of 4.  CMS Ex. 7 at 5.  A BIMS summary score of 4 is indicative of severe cognitive impairment.  See Long‑Term Care Facility Resident Assessment Instrument (RAI) 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score) at C-14, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited November 16, 2021).  Further, Resident # 1’s care plan documented that she was “unable to make daily decisions without cues/supervision [related to] impaired cognition.”  CMS Ex. 7 at 17.  Progress notes report that at the time of her medical emergency on July 7, 2019, Resident # 1 was “slumped over, drooling, flaccid on left side, no grip strength on left side, unable to follow commands, and pupils non reactive to light.”  CMS Ex. 7 at 8.
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10. A facility census report documents that Resident # 10, Resident # 11, and Resident # 13 resided in Hall 400.  CMS Exs. 4; 11 at 33.  A facility “Order Report” documents that Resident # 10 and Resident # 11 had orders for nectar-thickened liquids, and Resident # 13 had “NPO” orders for nothing by mouth. CMS Ex. 1 at 11, 27-28, 43-44; see CMS Exs. 4; 11 at 42, 46, 48.
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11. Although CMS argues that Petitioner “maintained a policy on children at the workplace,” it did not cite any evidence that Petitioner had such a policy prior to July 15, 2019.  CMS Br. at 7.
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12. Compare CMS Ex. 11 at 30 (contemporaneous text message from the CNA that “the nurse is allowing her 11 year old daughter to crush and pass meds on 400 hall”) with P. Exs. 1 at 2 (testimony of the DON, who was not present, that “[t]he daughter did not pass any medications to residents other than handing icy hot in a cup to one resident based on her mother’s directions”); 2 at 1-2 (nearly identical testimony by the administrator).
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13. The DON did not report the measures she took to investigate the child’s responses to call lights, and the record does not evidence that Petitioner documented each call light answered by the child and the response she provided.  Although Petitioner’s DON reported “[t]here were no known delays in any treatment or lack of treatment provided as a result of the daughter answering call lights” (P. Ex. 1 at 2), I note that some residents may lack the cognitive or communicative means to report any delays in responses to call lights.
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14. As neither the DON and nor the administrator were present at the facility when the child responded to call lights, the basis for their statements is unclear.
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15. I note that a resident who would ordinarily be denied ice water by the nursing staff may opportunistically request ice water from a well-meaning child.
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16. Without any citation to supporting evidence, Petitioner argues that “[t]he lack of referral of [C.S.’s] nursing license also supports a belief that the allegations were not as serious as now claimed.”  P. Br. at 14.  Petitioner has not submitted any evidence, such a report from a licensure database, that disciplinary charges have not been filed against C.S.
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17. To the extent Petitioner claims one surveyor completed a worksheet that reported in the negative regarding immediate jeopardy, I note that the immediate jeopardy determination that is the basis for the enforcement remedies imposed, and my review, is CMS’s determination.  See CMS Ex. 2 at 1 (CMS’s statement that it “’concur[red’ with the findings” of immediate jeopardy).
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18. C.S., accompanied by her child, reported for her next shift on July 11, 2019.  The evidence does not indicate that Petitioner took any disciplinary action against C.S. after it received the report that her child was crushing and passing medications.
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19. C.S. identified herself as a charge nurse.  CMS Ex. 11 at 63.  Staff members may be hesitant to report a charge nurse’s misconduct, particularly when it appears that the facility’s administration will take the side of the charge nurse.
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20. Petitioner did not develop its policy for children in the workplace as a response to the CNA’s allegation that the child had been crushing and passing medications.  Petitioner explained, “this policy was put in place as part of the plan of correction and was not in effect at the time of the alleged noncompliance.”  P. Br. at 10.  Thus, Petitioner only took action to address children in the workplace as a result of the survey.
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