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                              Regency Park Nursing Center, DAB CR5941 (2021)
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Regency Park Nursing Center, DAB CR5941 (2021)








  
  
    

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





Regency Park Nursing Center
(CCN:  31-5314),
Petitioner,
 
v.
 
Centers for Medicare & Medicaid Services.
Docket No. C-18-261Decision No. CR5941September 15, 2021

        
              
    

      DECISION

Following a survey by the New Jersey State Department of Health (state agency), the Centers for Medicare & Medicaid Services (CMS) concluded that Regency Park Nursing Center (Petitioner or facility) was not in substantial compliance with 42 C.F.R. §§ 483.20(k)(3)(i) and 483.75(e)(4).1
  CMS determined that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety, and CMS imposed two per‐instance civil money penalties (CMPs), one in the amount of $12,505 and a second in the amount of $15,005.  Together, the imposed CMPs total $27,510.  Petitioner requested a hearing to challenge CMS’s findings and the remedies imposed.

**Page 2**

For the reasons explained in this decision, I find that Petitioner failed to show that it was in substantial compliance with the cited regulations.  I further find that the CMP amounts imposed are reasonable.

I.      Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Hazlet, New Jersey.  *See e.g.*, CMS Exhibit (Ex.) 1 at 1.  State agency surveyors conducted a complaint investigation at Petitioner’s facility from August 10, 2016 through August 22, 2016. *See, e.g.*, CMS Ex. 1 at 1; CMS Ex. 6 at 1; Transcript (Tr.) at 26.  In a letter dated October 30, 2017, CMS informed Petitioner that, based on the state agency’s survey findings, CMS determined that the facility was not in substantial compliance with Medicare participation requirements and that the noncompliance represented immediate jeopardy to resident health and safety.  CMS Ex. 3 at 1.  CMS further informed Petitioner that it was imposing two separate per‐instance penalties:  a $12,505 a per-instance CMP for the immediate jeopardy noncompliance cited under tag F281 and a $15,005 per-instance CMP for the immediate jeopardy noncompliance cited under tag F495 (total CMP of $27,510).  *Id.* at 2.  CMS also confirmed that, following a revisit survey, Petitioner returned to substantial compliance effective September 24, 2016.  *Id.* at 1.

Petitioner timely requested a hearing, and the case was assigned to me.  I issued an acknowledgment and prehearing order (Prehearing Order) establishing a briefing schedule.  In accordance with that schedule, CMS filed a prehearing exchange, consisting of a combined motion for summary judgment and prehearing brief (CMS Br.) and 10 proposed exhibits (CMS Exs. 1-10), including the written direct testimony of one witness (CMS Ex. 10).  Petitioner filed a prehearing exchange consisting of a response in opposition to the motion for summary judgment (P. Response) a prehearing brief (P. Br.), and 16 proposed exhibits (P. Exs. 1-16), including the written direct testimony of three witnesses (P. Exs. 1, 11, 12).

In a ruling dated April 30, 2019, I denied CMS’s motion for summary judgment.  Ruling Denying Summary Judgment and Order Scheduling Prehearing Conference (Apr. 30, 2019).  I subsequently set a hearing to allow the parties to cross-examine witnesses.  Summary of Prehearing Conference and Notice of Hearing (May 30, 2019).  Petitioner requested to cross-examine CMS’s sole witness.  CMS waived its opportunity to cross‐examine Petitioner’s witnesses.  *Id.*at 2.

On September 26, 2019, I held a hearing via video-teleconference (VTC), and a transcript  was made of the proceeding.  I presided from the Departmental Appeals Board office in Washington, D.C.  Counsel for each party and the witness appeared via VTC from Princeton, New Jersey.  Gregory Palakow, Esq., represented Petitioner.  David Rawson, Assistant Regional Counsel, represented CMS.  I admitted CMS Exs. 1-10 and P. Exs. 1‐16.  Summary of Prehearing Conference and Notice of Hearing (May 30, 2019); Tr.

**Page 3**

at 8, 20.  During the hearing, counsel for Petitioner cross-examined Theresa Slisz, RN, a state agency surveyor.

Following the hearing, each party submitted a post-hearing brief (CMS Posthrg. Br.; P. Posthrg. Br.).

II.      Issues

The issues in this case are:

Whether Petitioner failed to comply substantially with the Medicare participation requirement at 42 C.F.R. § 483.20(k)(3)(i) (Tag F281);
	Whether Petitioner failed to comply substantially with the Medicare participation requirement at 42 C.F.R. § 483.75(e)(4) (Tag F495);
	If Petitioner did not comply substantially with Medicare participation requirements, whether I may review CMS’s determination as to the scope and severity of Petitioner’s noncompliance; and
	If Petitioner did not comply substantially with Medicare participation requirements, whether the per-instance penalties imposed are reasonable.III.      Jurisdiction

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

IV.      Discussion

**Statutory and Regulatory Framework**The Act sets requirements for SNF participation in the Medicare program.  The Act authorizes the Secretary of the U.S. Department of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. parts 483 and 488.

**Page 4**

A facility must maintain substantial compliance with program requirements in order to participate in Medicare.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)) or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  *Id.*  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  *Id.*

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  Among other enforcement remedies, CMS may impose a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a).  At the time CMS imposed remedies against the facility, in October 2017, the range for a per-instance CMP was $2,097 to $20,965.  42 C.F.R. § 488.438(a)(2); *see also*82 Fed. Reg. 9174, 9188 (Feb. 3, 2017).

If CMS imposes a CMP based on a noncompliance determination, then the SNF may request a hearing before an administrative law judge to challenge CMS’s determination of noncompliance that led to the imposition of an enforcement remedy.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a‐7a(c)(2), 1395i‐3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 488.434(a)(2)(viii), 498.3(b)(13)-(14); *see also* 5 U.S.C. §§ 554, 556.  A SNF may challenge CMS’s finding as to the level of noncompliance only if a successful challenge would affect the range of CMP amounts imposed on the SNF.  42 C.F.R. § 498.3(b)(14), (d)(10).  Further, where a challenge to the level of noncompliance is permitted, CMS’s determination as to the level of noncompliance must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

In a hearing before an administrative law judge, CMS must make a prima facie case that the SNF failed to comply substantially with federal participation requirements.  If CMS makes a prima facie case, the burden of persuasion shifts to the SNF, which must prove substantial compliance by a preponderance of the evidence.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health and Human Servs.*, No. 98-3789 (GEB) (D.N.J. May 13, 1999); *see* *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*,**129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001).

**Page 5**

**Findings of Fact, Conclusions of Law, and Analysis*****I find the following facts related to Tag F281 by a preponderance of the evidence.***Resident 22
 (R2) was admitted to the facility in June 2016 following a hospital stay for a fall.  CMS Ex. 8 at 3, 6.  Her goal was to return to Brandywine Assisted Living Facility (Brandywine), where she had been residing at the time of the fall.  CMS Ex. 8 at 6-7.  Her diagnoses included, notably, diabetes mellitus and hypothyroidism, but also hypertension, osteoporosis, and acute kidney failure.  CMS Ex. 8 at 3.

Relevant here, R2 had orders for Lantus (a type of insulin) for her diabetes and Levothyroxine (a generic form of Synthroid, a thyroid medication) for her hypothyroidism.  *See, e.g.*, CMS Ex. 8 at 23;*see also*Tr. at 29-30.  By the end of June, R2 had orders for 10 units of Lantus subcutaneously at bedtime and one 88 mcg tablet of Levothyroxine by mouth daily.  CMS Ex. 8 at 16, 18, 31-32; *see also* P. Ex. 1 at 1 (¶ 4).

On July 27, 2016, R2 was examined by a consulting endocrinologist, Cristina Xenachis, M.D.  CMS Ex. 8 at 34.  Dr. Xenachis recommended, among other things, increasing the dosages for both medications:  increasing the Lantus from 10 units to 18 units and increasing the Levothyroxine from 88 mcg to 100 mcg.  *Id.*at 35-38.  Dr. Xenachis also recommended adjustments to the Lantus dosage, based on observed blood glucose readings.  *Id.* at 37.  That same day, facility staff reported the recommended increased dosages to R2’s attending physician, Avtar S. Parhar, M.D., who****agreed with the recommendations and approved the changes by a telephone order.  P. Ex. 1 at 1 (¶ 5).  Staff subsequently documented the verbal order in the physician’s order sheet (POS) and updated the medication administration record (MAR) accordingly.  CMS Ex. 8 at 15, 28, 30.  In the week following, the facility administered the higher dosages of the medications to R2 consistent with the recent order.  *Id*.

Then, in early August, Dr. Parhar prepared R2’s medication orders in anticipation of R2’s discharge back to Brandywine.  P. Ex. 1 at 1 (¶ 6).  In his attestation, Dr. Parhar explains that he received R2’s “pre-printed medication orders for July” and then wrote prescriptions “consistent with” those orders without being aware of any discrepancies.  *Id.*There is no dispute that Dr. Parhar prepared orders for R2’s discharge that reflected the lower dosages for Lantus and Levothyroxine that had been in effect before R2’s endocrinology consultation.  CMS Ex. 5 at 1; P. Ex. 1 at 1 (¶ 6); *see also*CMS Ex. 9 at 1 (facility administrator’s email stating that Dr. Parhar’s orders for discharge “did not reflect the current medication dosage.”).

**Page 6**

Dr. Parhar’s attestation does not explain how he communicated his discharge medication orders to the facility.  *See generally*P. Ex. 1.  According to the surveyor, Dr. Parhar stated that, “I am sure I gave the verbal order to the nurse for Synthroid [Levothyroxine] 88 mcg and Lantus 10 units [*i.e.*, the lower dosages].”  CMS Ex. 10 at 3 (¶ 9).  This account differs somewhat from other parts of the record, which support that the facility’s administrator retrieved the written orders from Dr. Parhar and then transferred the orders to the facility’s social worker, who then transferred the orders to LPN1.  CMS Ex. 6 at 14 (surveyor interview notes with the facility’s administrator indicating that, “I picked up the [prescriptions] from the MD on 8/2/16 [illegible] came in [and] gave to the [social worker]”); CMS Ex. 9 at 3 (signed statement dated August 11, 2016, from social worker stating that “[t]he administrator gave me hard [prescriptions] from Dr. Parhar as requested by [Brandywine]”).  It is possible that Dr. Parhar verbally communicated his orders to a nurse (other than LPN1) *and* provided the written orders to the facility’s administrator, but that specific issue is immaterial.  There is no dispute that the orders eventually came into LPN1’s possession.

In a signed statement dated August 17, 2016, LPN1 stated that she received the medication orders for R2’s discharge from the social worker.  CMS Ex. 9 at 4; *see also* CMS Ex. 6 at 15 (surveyor interview notes with LPN1 indicating that, “The SW gave me the [discharge] papers that day.  She gave me the [prescriptions] as well.”).  LPN1 further stated that, upon discharging the resident, she noticed the discrepancy between R2’s then-current orders, reflecting the increased dosages for Lantus and Levothyroxine, and Dr. Parhar’s discharge orders, which reflected the lower dosages for those medications.  CMS Ex. 10 at 3 (¶ 10).  LPN1 then acknowledged that she “changed the dosage appropriately to coincide with the facility orders.”  CMS Ex. 9 at 4; *see also* CMS Ex. 10 at 3 (¶ 10).

There is no dispute that LPN1 marked and modified Dr. Parhar’s written discharge orders for Lantus and Levothyroxine so that the orders would reflect the increased dosages that had been in effect since the endocrinology consultation on July 27.  CMS Ex. 5 at 1-3; CMS Ex. 6 at 28; CMS Ex. 10 at 3 (¶ 10); Tr. at 48 (counsel for Petitioner stated, “I am not representing that the nurse did not change the discharge order”).  There is also no dispute that LPN 1 modified the orders without consulting Dr. Parhar or notifying anyone within the facility.  CMS Ex. 6 at 28; CMS Ex. 10 at 3 (¶¶ 9, 10); Tr. at 47-48.

The written orders reflecting LPN 1’s modifications traveled with R2 on her person as she was discharged to Brandywine.  CMS Ex. 5 at 2; *see also* CMS Ex. 9 at 3; CMS Ex. 6 at 15 (per surveyor interview notes, LPN 1 stated, “I sent the [discharge] medication list [and a] . . . paper [d]ischarge plan.”).  Separately, the social services director faxed at least one copy of Dr. Parhar’s medication orders to Brandywine as well.  CMS Ex. 9 at 3; CMS Ex. 5 at 1.  After R2 returned to Brandywine, staff there recognized a discrepancy

**Page 7**

with R2’s medication orders for Lantus and Levothyroxine, and then called Petitioner’s facility to clarify the orders.  P. Ex. 10 at 4; CMS Ex. 9 at 1.

The facility’s policy for “Administering Medications,” effective December 2010, provided, in part:

3.  Medications must be administered in accordance with the orders, including any required time frame.

4.  If a dosage is believed to be inappropriate or excessive for a resident, or a medication has been identified as having potential adverse consequences for the resident or is suspected of being associated with adverse consequences, the person preparing or administering the medication shall contact the resident’s Attending Physician or the facility’s Medical Director to discuss the concerns.

CMS Ex. 4 at 3.  The facility’s policy for “Physician Medication Orders,” effective 2013, provided, in part:

Medications shall be administered only upon the written order of a person duly licensed and authorized to prescribe such medications in this state.

**Policy Interpretation and Implementation**

No drugs or biologicals shall be administered except upon the order of a physician or nurse practitioner.
	All drug and biological orders shall be written, dated, and signed by the person lawfully authorized to give such an order. . . .****

The Charge Nurse shall call-in (to verify, clarify . . . [sic]) the order for all prescribed medications.CMS Ex. 4 at 1.

**Page 8**

***Petitioner did not substantially comply with the Medicare participation requirements at 42 C.F.R. §483.20(k)(3)(i) (Tag F281).***Under section 483.20(k)(3)(i), the services provided or arranged by the facility must “meet professional standards of quality and be provided by qualified persons in accordance with each resident’s written plan of care.”  Appellate decisions of the DAB have stated that “it is ‘reasonable to presume’ that [a facility’s own] policies reflect professional standards of quality.”  *See, e.g.*, *Perry Cnty. Nursing Ctr.*, DAB No. 2555 at 9 (2014) (quoting *Sheridan Nursing Care Ctr.*, DAB No. 2178 at 32 (2008)).

In her written direct testimony, the surveyor testified that, by “altering the physician prescriptions by changing the dosages of [Lantus and Levothyroxine], without notifying the physician,” LPN1 “practiced outside the scope of accepted nursing practice.”  CMS Ex. 10 at 2 (¶ 4), 4 (¶ 13) (in an interview with the surveyor, the Director of Nursing stated “nurses are not allowed to change the doctor’s scripts (prescriptions).”); *see also*CMS Ex. 6 at 21.  Further, as described above, Petitioner’s written policies required facility staff to contact a physician “[i]f a dosage is believed to be inappropriate or excessive for a resident.”  CMS Ex. 4 at 3.  The facility’s written policies further provided that “[a]ll drug and biological orders shall be written, dated, and signed by the person lawfully authorized to give such an order.”  *Id.* at 1.  Finally, Petitioner’s expert witness testified on written direct that LPN1 “used poor judgment” and “should have contacted the physician about the error in the dose on the discharge [prescriptions].”  P. Ex. 11 at 7 (¶¶ 23, 25).

Together, the expert testimony of the surveyor and Petitioner’s nurse consultant, combined with the facility’s written policies, support that it is standard nursing practice for a nurse to consult the attending physician (or medical director) if he or she believes a dosage ordered is “inappropriate” for a resident.  The surveyor’s testimony further supports that nurses are prohibited from altering an order for medications without consulting the prescribing physician.  I conclude that LPN1’s failure to consult Dr. Parhar when she noticed a discrepancy with the dosages for Lantus and Levothyroxine and her subsequent modification of the dosages without consulting Dr. Parhar was contrary to facility policy and did not meet professional nursing standards.

I also find that LPN1’s modification of the dosages was a failure to carry out Dr. Parhar’s orders.  LPN1’s modification essentially created new dosage orders for Lantus and Levothyroxine – new in the sense that they were different from the dosages Dr. Parhar had recently ordered on August 2.  Even if she did not administer the modified dosages to R2, LPN1 was tasked with preparing the orders for R2’s discharge, and her modified orders would have instructed Brandywine staff to administer the modified dosages, had no one noticed the discrepancies.  A number of appellate decisions have held that a

**Page 9**

nurse’s failure to carry out a physician’s order may constitute a failure to meet professional standards of quality under section 483.20(k)(3).  *Life Care Ctr. of Tullahoma*, DAB No. 2304 at 31 (2010) (citing *Georgian Court Nursing Ctr*, DAB No. 1866 at 8 (2003); *Emerald Oaks*, DAB No. 1800 at 37 (2001)), *aff’d*, *Life Care Ctr. Tullahoma v. Sec’y of U.S. Dept. of Health & Human Servs.*, 453 F. App’x 610 (6th Cir. 2011).

Petitioner does not specifically dispute that LPN1’s failure to consult Dr. Parhar or her modification of his dosage orders were outside the scope of nursing practice or contrary to facility policy.  P. Ex. 12 at 5 (¶ 18) (administrator counseled LPN1 that her action was “an unacceptable deviation from [facility] policy.”).  Instead, Petitioner points out that LPN1 in fact “corrected” the dosages ordered by Dr. Parhar for R2’s discharge so that the dosages would be consistent with R2’s then-current orders.  P. Posthrg. Br. at 17‐18.  As noted, when Dr. Parhar was preparing his discharge orders for R2, he relied on a copy of the medication orders that apparently reflected the previous, lower dosages that had been in effect before the endocrinology consultation on July 27.  P. Ex. 1 at 1 (¶ 6).  Dr. Parhar wrote prescriptions consistent with the prior orders, believing that they were up to date.  *Id.*Petitioner argues that “[a]lthough the LPN used poor judgment when she failed to call the physician before correcting the dose on the [prescription], there was no malice, intentional deception, tampering, or crime committed.”  P. Posthrg. Br. at 18; P. Ex. 11 at 6 (¶ 23).  Dr. Parhar also opined that the correction to the dosages “would have improved the clinical effectiveness of the medications for the resident.”  P. Ex. 1 at 1-2 (¶ 8).

Petitioner’s outcome-focused argument is unpersuasive and does not show that the facility was in substantial compliance.  At the time she saw Dr. Parhar’s discharge orders for the lower dosages and recognized a discrepancy, LPN1 presumably assumed that Dr. Parhar did not intend to change R2’s then-current orders – and based on that assumption – she modified the dosages.  CMS Ex. 5 at 2-3; CMS Ex. 6 at 28; CMS Ex. 9 at 4; CMS Ex. 10 at 3 (¶ 10); Tr. at 47-48.  It was fortunate that LPN1’s assumption turned out to be correct, but it was still improper for her to act without consulting Dr. Parhar.  LPN1’s good intentions do not justify her deviation from nursing standards of practice and the facility’s policy.  As Petitioner concedes, when LPN1 noticed the discrepancy, she could have confirmed with Dr. Parhar, but did not, which was “poor judgment.”  P. Posthrg. Br. at 18; *see also* P. Ex. 11 at 7 (¶ 25).

As for Dr. Parhar’s opinion that the correction “would have improved the clinical effectiveness of the medications” for R2 (P. Ex. 1 at 1-2 (¶ 8)), I will accept Dr. Parhar’s general point, even if it fails to take into account the confusion that was created for Brandywine staff, who had to reconcile conflicting medication dosage orders (P. Ex. 10

**Page 10**

at 4).  As a more general matter, however, nurses are not legally authorized3
 to prescribe medications to patients and so they are not permitted to modify a medication dosage order unless they consult with the prescribing physician.  CMS Ex. 10 at 2 (¶ 4); *see also*CMS Ex. 10 at 4 (¶ 13) (Petitioner’s Director of Nursing told the surveyor that “nurses are not allowed to change the doctor’s scripts (prescriptions).”); Tr. at 47 (“[a] nurse cannot write on a [prescription], only a doctor can write on the [prescription].”).  I have no difficulty concluding that a nurse who fails to consult the prescribing physician before modifying his medication orders places patients at risk of more than minimal harm.

Finally, in his testimony, the facility’s administrator states that “I later reported the actions of LPN No. 1 to the New Jersey Board of Nursing.  However, no action was taken by that Board against LPN No. 1.”  P. Ex. 12 at 5 (¶ 19).  The state board’s determination, however, does not change my conclusion.  I am not bound by that determination.  Moreover, the record provides no information about the evidence considered or standards applied by the state board in reaching its conclusion.  Therefore, its determination does not tend to show it is either more likely or less likely that the facility was out of substantial compliance with the federal requirement to provide services in accordance with professional standards of practice.  I therefore do not find the state board’s determination probative.

In summary, I conclude that LPN1’s actions with respect to R2’s medication discharge orders were contrary to facility policy and did not meet professional standards.  On that basis, I find that the facility was out of substantial compliance with 42 C.F.R. § 483.20(k)(3)(i).4

**Page 11**

***Petitioner did not substantially comply with the Medicare participation requirements at 42 C.F.R. § 483.75(e)(4) (Tag F495).***A “nurse aide” is any individual providing nursing or nursing-related services to residents in a skilled nursing facility, not including an individual who is a licensed health professional, a registered dietician, or a volunteer who provides such services without monetary compensation.  Act §§ 1819(b)(5)(F), 1919(b)(5)(F); 42 C.F.R. § 483.75(e)(1). Under the Act, a facility “must not permit an individual, other than in a training and competency evaluation program approved by the State, to serve as a nurse aide or provide services of a type for which the individual has not demonstrated competency.”  Act §§ 1819(b)(5)(C), 1919(b)(5)(C).  The Act also prohibits facilities from using an individual as a nurse aide on a full-time basis for more than four months unless the individual has completed a nurse aide training and competency evaluation program (NATCEP) approved by the State.  Act §§ 1819(b)(5)(A), 1919(b)(5)(A); 56 Fed. Reg. 48880, 48887 (Sept. 26, 1991).

The implementing regulations similarly prohibit a facility from using as a nurse aide an individual who is in his or her first four months at the facility, unless the individual:

(i)  Is a full-time employee in a State-approved training and competency evaluation program;
(ii)  Has demonstrated competence through satisfactory participation in a State-approved nurse aide training and competency evaluation program or competency evaluation program; or
(iii)  Has been deemed or determined competent as provided in § 483.150 (a) and (b).

42 C.F.R. § 483.75(e)(4).******

At the time of the August 2016 survey, the surveyor identified five individuals in their first four months at the facility who were serving as nurse aides, providing direct care to residents independently, but who were not certified or in a State-approved NATCEP.  CMS Ex. 7 at 5-8, 11-13; CMS Ex. 1 at 7-8.  Those individuals were assigned nurse aide (NA) numbers as follows:  NA1 (initials B.L.), NA2 (M.R.), NA5 (M.S.), NA6 (A.A.), and NA7 (E.G.).  CMS Ex. 7 at 2, 5-6.

Petitioner argues that each of the five individuals cited had either already completed a State-approved NATCEP at the time of the survey or were “enrolled . . . and were awaiting their start date.”  P. Posthrg. Br. at 20.  Petitioner adds that the regulation “affords a 120-day time frame during which facilities are permitted to enroll nurse aides in the NATCEP course and confirm completion,” and that each of the individuals cited was within her first four months at the facility and would complete her NATCEP certification by the end of the four-month period.  P. Posthrg. Br. at 2-3, 20-21.

**Page 12**

For one of the individuals, NA2 (M.R.), Petitioner submits a certificate to show that she completed a State-approved NATCEP and was certified before the survey.  P. Ex. 3 at 4.  I agree with Petitioner that the certificate shows that NA2 successfully completed a State-approved NATCEP and was certified September 14, 2015.5

For the remaining four individuals, Petitioner relies on a letter dated August 22, 2016, confirming that the individuals were “registered and enrolled” in the Ace Healthcare Training Institute for CNA program, for courses set to start at a later date.  CMS Ex. 7 at 1.  Specifically, NA1 (B.L.) and NA2 (M.R.)6
 were enrolled for a course set to run from August 29, 2016, through September 29, 2016, while NA5 (M.S.), NA6 (A.A.), and NA7 (E.G.) were enrolled for a course set to run from September 19, 2016, through November 2, 2016.  *Id*.

I disagree with Petitioner’s reading of the law, which would allow individuals to serve as nurse aides in a facility so long as they are merely registered and enrolled in a State-approved NATCEP and so long as they eventually complete their training under the program within their first four months at the facility.  P. Posthrg. Br. at 2-3.  Both the Social Security Act and the applicable regulation prohibit facilities from employing as a nurse aide any non-certified individual “other than [one] *in* a training and competency evaluation program approved by the State.”  Act §§ 1819(b)(5)(C), 1919(b)(5)(C); 42 C.F.R. § 483.75(e)(4)(i) (emphasis added).  I read the requirement that those providing

**Page 13**

nurse aide services must be “in” a State-approved NATCEP to mean that uncertified nurse aides are attending courses concurrently with their employment at the facility, in other words, that the NATCEP training is in progress or at least has started.  Neither the statute nor the regulation mentions enrollment or registration.7

Moreover, Petitioner’s reading would mean that an individual could serve as a nurse aide without having first completed any part of a State-approved NATCEP.  It is difficult to believe (at least without more express language) that the statute and regulation establishing the competency requirements for nurse aides would allow care to be provided in facilities by individuals without such training.  Indeed, a related part of the regulatory scheme, dealing with the requirements for approval of a NATCEP, states that a nurse-aide-training-program curriculum must include “[a]t least a total of 16 hours of training in [a list of] areas *prior to any direct contact with a resident*.”  42 C.F.R. § 483.152(b)(1) (emphasis added).  That list of areas includes:  (i) communication and interpersonal skills; (ii) infection control; (iii) safety/emergency procedures, including the Heimlich maneuver; (iv) promoting residents’ independence; and (v) respecting residents’ rights.  *Id.*  If a nurse aide must complete 16 hours of training in a NATCEP *before* having any direct contact with a resident, it would not make sense for that nurse aide to be able to provide direct care to residents while awaiting his or her NATCEP course to begin, as Petitioner contends.  Petitioner’s reading makes having a prerequisite 16 hours of training meaningless and is therefore inconsistent with the regulations for approval of NATCEPs.

Finally, in comments to the final rule, the drafters confirmed that a non-certified individual who has not yet started a State-approved NATCEP may not serve as a nurse aide in a SNF:

**Page 14**

*Comment*:  Many commenters requested clarification as to whether individuals who have been employed by a facility for less than four months and have not yet completed a NATCEP may serve as a nurse aide.  Some commenters indicated that we should specifically allow individuals who have not yet started a NATCEP to serve as nurse aides.  Others requested that no one be allowed to serve as nurse aides until he or she has completed a NATCEP or CEP.

*Response*:  . . . [A] facility may only permit an individual who has worked less than four months in the facility to serve as a nurse aide or provide services for which the individual has not demonstrated competence only when the individual is a full-time employee and is in a NATCEP approved by the State.  We have revised the provision in § 483.75(g)(3) (now redesignated as § 483.75(e)(4)) to state this requirement clearly.  Thus, during the four-month period discussed in § 483.75(g)(1), General Rule (now redesignated as § 483.75(e)(2)), full-time employees who are in a NATCEP may serve as nurse aides, and *individuals who have not yet started a NATCEP may not serve as nurse aides regardless of whether they are full-time employees*.

56 Fed. Reg. at 48,887 (emphasis added).

For all of these reasons, an uncertified individual who is merely enrolled or registered in (i.e., has not yet started) a State-approved NATCEP course, may not serve as a nurse aide in the facility.  Enrollment and registration are necessary, but not sufficient to be in compliance.  Because the facility used four individuals as nurse aides who were simply enrolled or registered in a NATCEP but who had “not yet started a NATCEP,” the facility was out of compliance.

Petitioner’s practice of allowing untrained individuals (i.e., those who were not “in” a State-approved NATCEP) to serve as aides, moreover, had the potential to cause more than minimal harm.  Petitioner’s misreading of the requirement allowed multiple individuals who were not “in” a qualifying NATCEP to have direct contact with residents.  In interviews with the surveyor, NA5 and NA6 both stated that their care for residents included washing, dressing, transferring with or without a Hoyer lift, feeding, and showering the residents.  CMS Ex. 10 at 7-8 (¶¶ 24, 26).  These are important areas of care and it is not difficult to conclude that allowing individuals without the required training to provide such care has the potential to result in more than minimal harm to residents.

On this point, Petitioner argues that there is no evidence of any poor care practices by the cited NAs or complaints that the cited NAs failed to provide appropriate care and services to residents.  P. Posthrg. Br. at 22-23.  Petitioner points out that the surveyor, on cross-

**Page 15**

examination, admitted that she did not observe any nurse aide render “poor care.”  *Id.*at 22.  Petitioner argues that the two residents interviewed, Unsampled Residents A and B, did not specifically identify any of the sampled NAs as the individuals who provided care to them.  P. Posthrg. Br. at 23.  Petitioner’s expert witness, Gail Rader, RN, came to a similar conclusion, finding “no evidence of any harm actual or potential attribute[able] to any of these NAs.”  P. Ex. 11 at 17 (¶ 60).  In her written direct testimony, Nurse Rader explains, “after a review of the surveyor worksheets and declaration as well as the CMS 2567 outlining the surveyor findings, I found no evidence of any observations by the surveyor of poor care practices by [the identified individuals] and no complaints specific to [the identified individuals] that they failed to provide appropriate care and services to residents.”  P. Ex. 11 at 16 (¶ 53).

I need not find that any of the individuals cited caused actual harm in order to conclude the facility was not in substantial compliance with its regulatory obligations; instead, I need only find that the facility’s deficiency posed a risk for more than minimal harm.  42 C.F.R. § 488.301.  Given that the facility allowed individuals without the requisite training to provide direct care to residents – including transfers with and without mechanical lifts – I find that the record supports that the facility’s practice had the potential for more than minimal harm.8

Finally, Petitioner points to other facts about the individuals cited, apparently to support their competence to serve as nurse aides.  According to Petitioner, the individuals underwent a two-week orientation program, which, according to Nurse Rader, “covered all the required components of training according to standards of practice” and went “beyond” the state regulatory requirements.  P. Posthrg. Br. at 21-22; P. Ex. 11 at 14, 17 (¶¶ 47, 60).  The individuals were also required to demonstrate their skills under the observation and direct supervision of the Assistant Director of Nursing.  P. Posthrg. Br. at 21-23.  Petitioner adds that three individuals were highly pre-qualified, including one

**Page 16**

who was a registered nurse in another country.  *Id.* at 20-21.  Petitioner further explains that the facility’s practice was to assign a CNA as a “buddy” for each nurse aide for a period of time and to ensure that all nurse aides worked under the direct supervision of an LPN and/or RN.  *Id.* at 22.

Even accepting as true that the individuals Petitioner employed may have had prior experience and training that was relevant to their work as nurse aides at the facility and that they participated in the facility’s in-house orientation and training program, this does not establish substantial compliance with the regulation.  The facility’s training program is not a State-approved NATCEP, as the surveyor stated during the hearing.  Tr. at 134.  The statute and regulations, moreover, define the competency requirements for nurse aides, specifically spelling out the training program requirements, including basic aspects of the curriculum.  42 C.F.R. § 483.152.  Despite Petitioner’s argument and Nurse Rader’s opinions, I may not depart from the requirements established in the statute and regulations to find that Petitioner’s own training may be comparable or serve as a substitute.  *1866ICPayday.com, L.L.C.*, DAB No. 2289 at 14 (2009) (“[a]n [administrative law judge] is bound by applicable laws and regulations”).

In sum, Petitioner has not shown that four of the five individuals cited met the statutory and regulatory nurse aide competency requirements.  Accordingly, Petitioner was out of substantial compliance.

***Petitioner has no right to challenge the immediate jeopardy determinations***Petitioner argues that CMS’s immediate jeopardy determinations for the two deficiencies discussed above are reviewable.  Indeed, much of Petitioner’s argument seems intended to prove that CMS erred in citing immediate jeopardy (i.e. Petitioner contends that its noncompliance was merely technical and did not cause harm to any resident).  *See, e.g.,*P. Posthrg. Br. at 19 (although LPN1 deviated from facility policy in changing R2’s prescriptions, “there was no actual or potential serious harm or threat of death as a result”).

Under the governing regulations, an administrative law judge may review CMS’s scope and severity finding, including a finding of immediate jeopardy, “only if a successful challenge would affect:  (l) the range of the CMP amounts that CMS could collect; or (2) a finding of substandard quality of care that results in the loss of approval of a facility’s NATCEP.”  42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii).  Petitioner acknowledges that it may challenge the level of noncompliance only “**if**a successful challenge would affect the range of CMP’s that CMS could collect.”  P. Posthrg. Br. at 24 (bold type in original).

**Page 17**

Petitioner’s position appears to be that its challenge to CMS’s finding of immediate jeopardy falls within the scope of the regulation because the facts in this case support only a lower scope and severity level, one where CMS would be without basis to impose a CMP at all.  *Id*.9
  Petitioner then essentially repeats its arguments above that the two deficiencies cited are unsupported.  *Id*. at 24-25.  Similarly, Petitioner contends that the scope and severity determination for each deficiency is reviewable because it “impacts the amount and range of the CMP.”  *Id.* at 25.  Petitioner cites a CMS memorandum that discusses how CMS and state agencies consider various factors, including the scope of severity of a deficiency, to select an appropriate enforcement remedy.*****Id.* (citing P. Ex.13).

Petitioner’s arguments treat the *amount*and *range*of the CMP as interchangeable.  This approach misreads the regulations.  Petitioner correctly points out that the scope and severity cited, as well as aggravating factors, past non-compliance, and specific-survey related information may affect CMS’s selection of a CMP *amount*.  *Id*.  However, the scope and severity determination does not affect the CMP*range* CMS may choose when imposing a per-instance penalty.

In the case of a per-instance CMP, the regulations provide for a *single* penalty range without regard to the level of noncompliance.  42 C.F.R. § 488.438(a)(2).  Thus, if CMS decides to impose a per‐instance CMP, the amount selected must fall within the single range, which at the time CMS imposed remedies in October 2017, was $2,097 to $20,965.42 C.F.R. § 488.438(a)(2); 82 Fed. Reg. 9174, 9188 (Feb. 3. 2017).  There is no separate, lower range (and no zero-amount range) for CMS to choose when it is without basis to impose a CMP.  Indeed, if Petitioner successfully showed that CMS had no basis to impose a CMP at all, there would be no further scope and severity determination to review.

In summary, because there is only a *single*range for per-instance CMPs, the CMP amount selected by CMS after considering the various factors must fall within that single range.  Therefore, Petitioner’s challenge to the citation of immediate jeopardy does not affect the range of CMPs that may be imposed.  *See NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *see also* *Oaks of Mid City Nursing & Rehab. Ctr*., DAB No. 2375 at 24 (2011).  Accordingly, Petitioner’s argument that it has a right to challenge

**Page 18**

the scope and severity determination in this case is without merit.  42 C.F.R. § 488.438(a)(2).  Under these circumstances, the regulations do not permit me to review CMS’s immediate jeopardy determinations.

***The two per-instance CMPs imposed, in the amounts of $12,505 and $15,005, are reasonable.***I evaluate whether a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

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

Besides arguing that the facility was in substantial compliance, Petitioner does not argue that any particular regulatory factor supports a reduction of the CMP amounts proposed by CMS.  P. Posthrg. Br. at 26 (“taking in the totality of the evidence[,] the CMP for immediate jeopardy is not reasonable****due to the inaccurate assumptions made by the surveyors and their refusal to consider all evidence in coming to their conclusions to cite the facility as not being in substantial compliance with Medicare participation requirements.”).  For that reason alone, I could conclude the CMP amounts are reasonable.  *See Coquina Ctr.*, DAB No. 1860 at 32.  However, I have reviewed the regulatory factors and explain why I find that they support a conclusion that the CMP amounts are reasonable.

CMS imposed a $12,505 per-instance CMP for the noncompliance based on LPN1’s actions with respect to R2’s discharge medication orders, which is an amount close to the middle of the CMP range in effect at the time CMS imposed the remedy.10
  I find the

**Page 19**

noncompliance to be very serious.  It was fortunate that LPN1’s modification did not result in actual harm to R2.  However, the absence of actual harm does not diminish the *risk* of serious harm when a nurse modifies an order for medication dosages without consulting the physician, especially when dealing with certain drug categories and more vulnerable residents.  The facility’s culpability is also significant, as there was no justification for LPN1’s deviation from the facility’s own written policy that required her to consult the physician if “a dosage is believed to be inappropriate.”  CMS Ex. 4 at 3.

CMS imposed a $15,005 per-instance CMP for the noncompliance based on the facility’s use of non-certified nurse aides who were not “in” a State-approved NATCEP.  The CMP amount falls in the middle to upper part of the CMP range in effect.  I assume that Petitioner did not willfully ignore the federal statutory and regulatory provisions regarding nurse aide competency.  Nevertheless, by relying on its interpretation of State regulations, without considering that federal requirements might be more stringent, Petitioner was culpable (in the sense of responsible) for the deficient practice.  Moreover, Petitioner’s misinterpretation of the requirement was serious, as the facility failed to ensure that its non-certified nurse aides were “in” a State-approved NATCEP.  At least four individuals provided care directly to residents, including washing, dressing, transferring with or without a Hoyer lift, feeding, and showering the residents.  It is not hard to imagine the potential serious consequences of allowing individuals who do not meet competency requirements to provide such care to nursing home residents.

In summary, I find that the per-instance CMP amounts imposed for the two deficiencies are reasonable based on the factors of seriousness and culpability.

IV.      Conclusion

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

          /s/
        Leslie A. Weyn

                      Administrative Law Judge
      1. Effective November 28, 2016, 42 C.F.R. § 483.20(k)(3)(i) was re-designated as 42 C.F.R. § 483.21(b)(3)(i), while 42 C.F.R. § 483.75(e)(4) was re-designated as 42 C.F.R. § 483.35(d)(3).   81 Fed. Reg. 68,688, 68,827, 68,830, 68,859, 68,862 (Oct. 4, 2016).   I apply the regulations in effect at the time of the survey.   See Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey). back to note 1
                      2. To protect the resident’s privacy, I refer to the resident’s numerical identifier assigned during the survey.  CMS Ex. 7 at 17. back to note 2
                      3. New Jersey state law defines the practice of nursing as a registered professional nurse as “diagnosing and treating human responses to actual or potential physical and emotional health problems . . . and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist.”   N.J. Stat. Ann. § 45:11-23. back to note 3
                      4. CMS also contends that Petitioner failed to comply with 42 C.F.R. § 483.20(k)(3)(i) because LPN1 failed to document the telephone order for R2’s discharge.   CMS Posthrg. Br. at 3; see also CMS Ex. 1 at 1.   Having found that LPN1’s actions with respect to R2’s discharge medication orders is sufficient to support a finding of noncompliance, I decline to address the allegation that Petitioner failed to document R2’s discharge orders properly because that allegation is not material to the outcome of this case.   See, e.g., Heritage Plaza Nursing Ctr., DAB No. 2829 at 4 n.3 (2017). back to note 4
                      5. Petitioner also argues in passing that NA7 was certified before the survey.  P. Posthrg. Br. at 13-14.  But this argument is based on a part of the surveyor notes that misidentified NA7 as an individual with the initials S.B., who was certified on August 4, 2016, instead of an individual with the initials E.G., who was not certified before the survey.  P. Posthrg. Br. at 13-14 (citing Tr. at 99-100); CMS Ex. 6 at 30, 40.  Aside from that passing argument, Petitioner appears to recognize that NA7 actually refers to E.G., as Petitioner submitted E.G.’s documentation as its evidence for NA7.  P. Exs. 6, 7; Tr. at 148; see also id. at 146-47 (discussion during the hearing regarding whether certain testimony was for the correct NA7).  CMS confirmed that NA7 refers to an individual with the initials E.G., who, again, was not certified before the survey.  CMS Posthrg. Br. at 12 n.2 (citing CMS Ex. 7 at 1, 13); compare CMS Ex. 1 (SOD indicating NA7’s date of hire of August 8, 2016), with CMS Ex. 7 at 13 (notes indicating NA7 was E.G. whose date of hire was August 8, 2016).  Accordingly, of the five individuals initially identified by the surveyor as not certified or in a State-approved NATCEP, only one, NA2 (M.R.), was certified before the survey. back to note 5
                      6. At the time of the survey, the facility was apparently unaware that NA2 (M.R.) was already certified and so the facility enrolled her in a NATCEP along with the other cited individuals.  See Tr. at 143-44. back to note 6
                      7. New Jersey state regulations do mention enrollment, as Petitioner points out.  P. Posthrg. Br. at 20.   Those regulations state that an individual is competent to work as a nurse aide if the individual has been employed for less than 120 days and “is currently enrolled in an approved nurse aide in long term care facilities training course and scheduled to complete the competency evaluation program (skills and written/oral examination) within 120 days of employment.”   N.J. Admin Code § 8:39-43.1 (emphasis added).   To be sure, there is a stronger argument that the state regulatory language is consistent with Petitioner’s view of the competency requirements for nurse aides.   But that argument is misplaced as the state requirements do not control.   As appellate decision of the DAB have explained, “[f]ederal law, not State law, governs what constitutes substantial compliance (or noncompliance) with the requirements for long-term care facilities participating in the Medicare program.”   Lakeridge Villa Healthcare Ctr., DAB No. 2396 at 13 (2011) (citing Cedar Lake Nursing Home, DAB No. 2344 at 10 (2010)). back to note 7
                      8. I nevertheless observe that, according to surveyor interview notes, Unsampled Resident A stated both:   “I sat [with] wet pads today all day” and “I was changed [twice].”   CMS Ex. 6 at 26; CMS Ex. 10 at 8-9 (¶ 28).   In her written direct testimony, Nurse Rader highlights the apparent inconsistency of those statements while also noting that the resident was “not oriented.”   P. Ex. 11 at 16-17 (¶ 56); P. Posthrg. Br. at 23 (citing CMS Ex. 6 at 26).   Contrary to Nurse Rader’s suggestion, I do not find the resident’s statements to be necessarily inconsistent.   The resident may very well have been changed twice that day by the time the surveyor interviewed her, at 3:05 p.m., but she still may have sat with wet pads “all day” because she needed to be changed more often.   See CMS Ex. 6 at 26.   There is no dispute that NA5 was assigned to Unsampled Resident A on the date the resident was interviewed (CMS Ex. 10 at 9 (¶ 28)) and so the resident’s comments provide at least some support that NA5 was responsible for that aspect of the resident’s condition. back to note 8
                      9. Petitioner argues:   “Here, the level of non-compliance can be reviewed, because if the deficiencies at issue were cited at scope and severity level “D” or lower . . .   CMS would be without basis to assess a CMP.”   P. Posthrg. Br. at 24.   I assume Petitioner meant to argue that the deficiencies at issue should have been cited at a scope and severity of lower than “D.”   Upon a finding of substantial noncompliance with a scope and severity level “D” (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm), CMS has the discretion to impose enforcement remedies, including CMPs.   Act § 1819(h)(2); 42 C.F.R. § 488.408. back to note 9
                      10. The maximum per-instance CMP at the time the remedy was imposed was $20,965.   82 Fed. Reg. at 9188. back to note 10 Back to top
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