Signature Health Care of Pikeville, DAB CR5125 (2018)

DECISION

Petitioner, Signature Health Care of Pikeville, was not in substantial compliance with program participation requirements from March 8, 2014 through June 11, 2014, based on violations of 42 C.F.R. §§ 483.13(c)(2)-(4) (Tag F2251); 483.13(c) (Tag F226); 483.25(m)(2) (Tag F333); 483.60(c) (Tag F428); 483.75 (Tag F490); and 483.75(o) (Tag

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F520).2  There is a basis for imposing the following enforcement remedies, which are reasonable:  a $4,150 per day civil money penalty (CMP) effective March 8, 2014 through March 30, 2014; a $150 per day CMP effective March 31, 2014 through May 23, 2014; a $4,050 per day CMP effective May 24, 2014 through May 30, 2014; a $250 per day CMP effective May 31, 2014 through June 11, 2014; and a denial of payment for new admissions (DPNA) for the period May 13, 2014 through June 11, 2014.

I.  Background

Petitioner is located in Pikeville, Kentucky, and participates in Medicare as a skilled nursing facility (SNF) and Medicaid as a nursing facility (NF).  Joint Stipulations of Undisputed Facts (Jt. Stip.) ¶ 1; Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1 at 1.  On April 3, 2014, the Kentucky State Survey Agency (state agency) completed a survey of Petitioner and found Petitioner not in substantial compliance with program participation requirements due to violations of 42 C.F.R. §§ 483.13(c)(1)(ii)-(iii), (c)(2)-(4) (Tag F225);3 483.25(m)(2) (Tag F333); 483.60 (Tag F428); and 483.75(o) (Tag F520), all alleged by the surveyors to have posed immediate jeopardy to Petitioner’s residents as of March 8, 2014.  Jt. Stip. ¶¶ 2-4; CMS Ex. 2 at 3-36, 49-83, 85-115, 119-150; CMS Ex. 5 at 1.  The survey also found noncompliance, which Petitioner does not challenge, based on violations of 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282) (scope and severity (s/s) E4), 483.25(k) (Tag F328) (s/s E), 483.35(i) (Tag F371) (s/s E), and 483.65 (Tag F441) (s/s D).  CMS Ex. 2 at 36-49, 83-84, 115-119.

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CMS notified Petitioner on April 28, 2014, that it was imposing enforcement remedies based on the April 3, 2014 survey findings.  CMS informed Petitioner that Petitioner had abated the immediate jeopardy conditions identified during the survey on March 31, 2014, but that Petitioner remained out of substantial compliance with program participation requirements.  CMS also notified Petitioner that it was imposing the following enforcement remedies based on the April 3, 2014 survey findings:  termination of Petitioner’s provider agreement on August 25, 2014, if Petitioner remained out of substantial compliance through that date; a CMP in the amount of $4,150 per day, effective March 8, 2014 through March 30, 2014; a CMP in the amount of $150, effective March 31, 2014, and continuing until the facility returned to substantial compliance; and a DPNA effective May 13, 2014, if Petitioner remained out of substantial compliance through that date.  CMS Ex. 5 at 2-4; Jt. Stip. ¶¶ 5-6.  The April 28, 2014 notice further informed Petitioner that it was ineligible to conduct a nurse aide training and competency evaluation program (NATCEP) for two years.  The parties take the position that the loss of NATCEP authority is not an issue in this case as Petitioner did not have such a program.  CMS Ex. 5 at 5; P. Ex. 1 at 5, Jt. Stip. ¶ 7.

Petitioner requested a hearing before an administrative law judge (ALJ) on June 11, 2014 (June RFH).  Petitioner requested review of the CMS determinations announced in its April 28, 2014 notice, specifically “CMS’ findings of substandard quality of care, or immediate jeopardy . . . [and] the remedies imposed as a result of those findings.  June RFH at 2.  Petitioner alleged that it would show that it was in substantial compliance with all regulatory requirements at the time of the survey or that any noncompliance did not amount to substandard quality of care, pose immediate jeopardy, or that immediate jeopardy or substandard quality of care did not last as long as CMS alleges.  But Petitioner went on to state that it did not “appeal the ‘non-jeopardy’ deficiencies cited” by the survey that ended on April 3, 2014.  June RFH at 2.  Petitioner’s allegations are facially inconsistent.  Petitioner is clear that it is not seeking ALJ review of the deficiencies cited as noncompliance but not as posing immediate jeopardy or amounting to substandard quality of care.  Therefore, Petitioner effectively waived any argument that it was not in substantial compliance as alleged by the survey for the period alleged based upon the non-jeopardy deficiency citations.  Based on a careful parsing of the request for hearing, I conclude that Petitioner has preserved its right to review related to

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the survey that ended April 3, 2014, as to whether there was any deficiency under Tags F225, F333, F428, and F520; whether those deficiency citations posed immediate jeopardy or amounted to substandard quality of care; and whether the $4,150 per day CMP was reasonable.  Petitioner did not preserve by its request for hearing any right to ALJ review of any alleged deficiencies that were not alleged to pose immediate jeopardy.  The June RFH did not appear to request review as to the reasonableness of the $150 per day CMP or the DPNA that CMS imposed as the CMP is in the lower range of authorized CMPs and the DPNA may be based on non-jeopardy level deficiencies.  Jt. Stip. ¶ 8, June RFH at 2-6, Transcript (Tr.) at 53-54.  However, Petitioner’s subsequent request for hearing indicates Petitioner did not intend to waive review of the CMP in the lower range or the DPNA, as discussed hereafter.

Petitioner’s hearing request was docketed as C-14-1334 and assigned to me for hearing and decision on June 24, 2014, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at my direction.

Petitioner’s June request for hearing was filed before Petitioner was notified of the results of a revisit and complaint survey conducted on June 4, 2014.  Therefore, the survey completed on June 4 is not included in the June request for hearing, but it is covered by Petitioner’s September request for hearing.  During the June 4, 2014 survey, the state agency found continuing noncompliance with program participation requirements.  The state agency found violations of 42 C.F.R. §§ 483.13(c)(2)-(4) (Tag F225),5 483.13(c) (Tag F226); 483.75 (Tag F490); and 483.75(o) (Tag F520), all alleged to be at scope and severity J, which is immediate jeopardy.  The surveyors determined that immediate jeopardy was abated on May 31, 2014.  Jt. Stip. ¶ 9; CMS Ex. 64 at 2, 33, 35, 59, 62, 83, 85; 65 at 2, 33, 35, 59, 62, 83, 85.  No additional non-jeopardy deficiencies were cited by the survey that ended on June 4, 2014.

CMS notified Petitioner on July 18, 2014, that additional surveys completed on March 25, 2014, and April 3, 2014, found continued noncompliance with program participation requirements, but complaint surveys completed on April 22, 2014 and May 15, 2014, cited no additional deficiencies.  CMS notified Petitioner that the revisit and complaint survey completed on June 4, 2014, found that noncompliance continued and new deficiencies cited by the survey again posed immediate jeopardy from May 24, 2014 to May 31, 2014, and amounted to substandard quality of care.  CMS advised Petitioner that

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the remedies imposed by the April 28, 2014 CMS-notice remained in effect and the CMP was increased to $4,050 per day for the period May 24 through May 30, 2014, and then reduced to $250 per day effective May 31, 2014 and continuing until Petitioner returned to substantial compliance.  P. Ex. 1 at 1-2, 4; Jt. Stip. ¶ 10.  The July 18, 2014 notice also informed Petitioner that it was ineligible to conduct a NATCEP for two years.

On June 25, 2014, the state agency completed a complaint survey of Petitioner and found Petitioner continued not to be in substantial compliance with program participation requirements.  The surveyors cited regulatory violations that they alleged posed immediate jeopardy to Petitioner’s residents from June 12 to June 25, 2014, and amounted to substandard quality of care.  CMS notified Petitioner on July 21 and 22, 2014, that the remedies imposed in the April 28, 2014 and July 18, 2014 notices remained in effect but the CMP was increased to $5,500 per day for the period June 12 through June 24, 2014, and then reduced to $300 per day effective June 25, 2014 and continuing until Petitioner returned to substantial compliance or its participation terminated.  CMS Ex. 46; P. Ex. 2; Jt. Stip. ¶ 11; Tr. at 54-55.

On July 31, 2014, the state agency conducted a final revisit survey and found that Petitioner returned to substantial compliance on July 13, 2014.  CMS Ex. 62; Jt. Stip. ¶ 13.  CMS notified Petitioner on August 6, 2014, that it also determined that Petitioner returned to substantial compliance effective July 13, 2014.  CMS advised Petitioner that the DPNA ran from May 13, 2014 through July 12, 2014, and the termination action was rescinded.  CMS Ex. 63, Jt. Stip. ¶¶ 14-15.

On September 12, 2014, Petitioner filed a second request for hearing (September RFH).  Petitioner stated that it requested a hearing related to the allegations of noncompliance and sanctions imposed by CMS notices dated July 18 and July 22, 2014.  Petitioner referred to its prior request for hearing docketed as C-14-1334.  Petitioner also stated that on July 21, 2014, CMS sent Petitioner a notice that made additional allegations of noncompliance and imposed additional sanctions.  Petitioner stated that it waived a hearing related to “the sanctions set forth in the July 21, 2014” notice, electing the regulatory 35 percent reduction in the CMP imposed by the July 21, 2014 notice.  September RFH at 1, 2.  Petitioner states in its September request for hearing that in docket number C-14-1334 the CMP of $4,150 per day from March 8 through March 30, 2014, $150 per day effective March 31, 2014, and the DPNA effective May 13, 2014, were at issue.  September RFH at 2.  In its September request for hearing Petitioner specifically requested review of the deficiencies that CMS cited during the survey completed on June 4, 2014, that alleged immediate jeopardy and amounted to substandard quality of care, specifically Tags F225, F226, F490, and F520.  The June 4, 2014 survey cited no deficiencies that were not alleged to pose immediate jeopardy.  Petitioner specifically challenged the $4,050 per day CMP that CMS imposed based on the deficiencies cited by the June 4, 2014 survey.  September RFH at 1-3; Jt. Stip. ¶ 12.

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The September request for hearing was docketed as C-14-1916 and assigned to me for hearing and decision on October 1, 2014, and a Consolidation Order was issued at my direction in which I consolidated docket numbers C-14-1334 and C-14-1916 for hearing and decision and dismissed docket C-14-1334.  On March 16, 2015, I notified the parties that the case was scheduled for hearing from August 25 through August 28, 2015, by video teleconference.

A hearing was convened by video teleconference on August 25, 26, and 27, 2015, and a transcript of the proceedings was prepared.  CMS offered CMS Exs. 1 through 65, all of which were admitted as evidence except CMS Exs. 20, 22, and 23, and pages 3 through 9 and 11 of CMS Ex. 58.  Tr. 26-42.6  Petitioner offered Petitioner’s Exhibits (P. Exs.) 1 through 40, all of which were admitted and considered as evidence.  Tr. 43.

CMS called the following witnesses to testify at hearing:  Surveyor Keith Partin; Surveyor Sherry Miracle, R.N. (Registered Nurse); Surveyor Patricia Liford, R.N.; and Surveyor Beth Cima, R.N.  Petitioner called the following witnesses:  Scott Thacker, Petitioner’s Admission Coordinator; Jessica Frost, R.N., a nurse at Petitioner’s facility; Jamie Lewis, L.P.N. (Licensed Practical Nurse), a nurse at Petitioner’s facility; Annette Wenzler, R.N., a chief nurse executive for Signature Healthcare, Petitioner’s parent company; Samantha Cook, R.N., Petitioner’s Director of Nursing, who at the time of the surveys was Petitioner’s Minimum Data Set (MDS) Coordinator and Assistant Director of Nursing (ADON); Beverly Lowery, R.N., Vice President of Regulatory Compliance and Quality Assurance for Signature Healthcare; and Patrick Shawn O’Conner, Petitioner’s Administrator at the time of the June 4, 2014 survey.

CMS filed its post-hearing brief (CMS Br.) on November 30, 2015.  Petitioner filed its post-hearing brief (P. Br.) and related documents on November 24, 2015.  CMS filed its reply brief (CMS Reply) and related documents on December 30, 2015.  Petitioner filed its reply (P. Reply) on December 14, 2015.

II.  Discussion

A.  Issues

Whether there is a basis for the imposition of an enforcement remedy; and, if so,

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Whether the remedy imposed is reasonable.

B.  Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary of Health and Human Services (Secretary) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.7  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory DPNA.  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements.  “Substantial compliance (complying substantially) means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Therefore, a facility may violate a statutory or regulatory requirement, but it is not subject to enforcement remedies if the violation does not pose a risk for more than minimal harm.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  State survey agencies survey facilities that

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participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10-.28, 488.300‑.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

Petitioner was notified in this case that it was ineligible to conduct a NATCEP for two years.  The parties stipulated that Petitioner did not have a NATCEP at the time of the survey and stated that the “remedy is not at issue here.”  Jt. Stip. ¶ 7.  Ineligibility to conduct a NATCEP is not an enforcement remedy that either the state agency or CMS have the authority or discretion to impose.  42 C.F.R. § 488.406.  Petitioner became ineligible to be approved to conduct a NATCEP for two years by operation of law.  I have no authority to declare the ineligibility invalid except to the extent that I conclude that there was no trigger to the ineligibility.  The two-year period of ineligibility began on April 3, 2014 and ended on April 2, 2016.  CMS Exs. 4 at 1; 5 at 5; 42 C.F.R. § 483.151(b)(2).  Although the period of ineligibility has already expired, the ineligibility to conduct a NATCEP remains an issue as it triggers Petitioner’s right to request review of the scope and severity determinations and the determination of substandard quality of care that triggered the ineligibility to be approved to conduct a NATCEP.  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a skilled nursing or nursing facility that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $5,000; or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. § 483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or § 483.25 (Quality of Care) that are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  In this case, the alleged substandard quality of care triggered an extended or partial extended survey, which triggered the ineligibility to conduct a NATCEP and is a

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basis for ALJ review.  42 C.F.R. §§ 483.151(b)(2)(iii); 498.3(b)(14)(ii) & (16) (finding of substandard quality of care that results in loss of approval of NATCEP is initial determination subject to review).  The CMP proposed by CMS also triggered ineligibility to be approved to conduct a NATCEP in this case.

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or would impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted).  The Board has long held that the petitioner bears the burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904, aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  However, only when CMS makes a prima facie showing of noncompliance, is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The standard of proof, or quantum of evidence required, is a preponderance of the evidence.  CMS has the burden of coming forward with the evidence and making a prima facie showing of a basis for imposing an enforcement remedy.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient

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(together with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.”  Id.; Batavia Nursing & Convalescent Ctr., DAB No 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  Black’s Law Dictionary 1228 (8th ed. 2004).

In Evergreene, the Board explained its “well-established framework for allocating the burden of proof on the issue of whether [a] SNF is out of substantial compliance” as follows:

CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.  If CMS makes this prima facie showing, then the SNF must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.

DAB No. 2069 at 7.

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence given the greatest weight in my decision-making.8  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. & Prac. § 5:64 (3d ed. 2013).

1.  Petitioner did not request review of the following deficiency citations from the survey that ended on April 3, 2014 (CMS Ex. 2); the

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deficiency citations are administratively final; and the deficiencies are a basis for the imposition of enforcement remedies:  42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282) (s/s E), 483.25(k) (Tag F328) (s/s E), 483.35(i) (Tag F371) (s/s E), and 483.65 (Tag F441) (s/s D) (unchallenged deficiencies).

2.  The April 3, 2014 survey determined that the immediate jeopardy determined to have begun on March 8, 2014, was abated as of March 31, 2014; therefore, the period of immediate jeopardy at issue related to the April 3, 2014 survey is March 8, 2014 through March 30, 2014.

3.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.13(c)(2)-(4) (Tag F225).

4.  The violation of 42 C.F.R. § 483.13(c)(2)-(4) (Tag F225) posed a risk for more than minimal harm and amounted to noncompliance.

5.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

Based upon Petitioner’s request for hearing, the deficiencies at issue before me related to the survey completed on April 3, 2014, are those cited as violations of 42 C.F.R. §§ 483.13(c)(2)-(4) (Tag F225); 483.25(m)(2) (Tag F333); 483.60(c) (Tag F428); and 483.75(o) (Tag F520) and alleged to have posed immediate jeopardy to Petitioner’s residents.

After complete review of the entire record, I conclude that it is only necessary to discuss the example of Resident 8 to determine that the alleged violations of 42 C.F.R. § 483.13(c)(2)-(4) (Tag F225); 483.25(m)(2) (Tag F333); 483.60(c) (Tag F428); and 483.75(o) (Tag F520) were correctly cited and that there was immediate jeopardy from March 8, 2014 through March 30, 2014.  Therefore, I conclude it is unnecessary to discuss any other examples cited under those deficiency citations.  The facts related to the example of Resident 8 are set forth here but apply equally to the noncompliance cited under Tags F333, F428, and F520.

a.  Facts Applicable to All Deficiency Citations in Issue Related to Resident 8

Resident 8 was 80 years old when admitted to Petitioner on September 9, 2013.  Resident 8 had a history of falls, atrial fibrillation, coronary artery disease, rheumatoid arthritis, anemia, and urinary tract infections (UTI).  CMS Ex. 21 at 1, 9, 22-23, 34, 77, 83; P. Ex. 10 at 4; P. Ex. 13 at 1-2; P. Ex. 14 at 1.  Prior to Resident 8’s admission to Petitioner’s facility, she was admitted to the hospital (Pikeville Medical Center) on August 27, 2013,

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with a chief complaint of confusion.  CMS Ex. 21 at 22; P. Ex. 13 at 1.  The hospital discharged her to home on September 6, 2013, following inpatient rehabilitation.  P. Ex. 14 at 1.

On September 9, 2013, Resident 8 was admitted to Petitioner’s facility.  CMS Ex. 21 at 9, 76, 83-84; P. Ex. 5.  An admission nurse note reflects Resident 8 was admitted under the care of Dr. Martin, and she was on the antibiotic Levaquin for a UTI.  CMS Ex. 21 at 9.

During the survey that ended on April 3, 2014, the surveyors retrieved from Petitioner’s records for Resident 8 a copy of an admission summary dated August 27, 2013, from the resident’s hospitalization that began on August 27, 2013, at the Pike Medical Center.  Drug allergies listed in that document included Macrodantin® in addition to Darvocet®, Elavil®, flu vaccine, penicillin, Ultram®, and codeine.  CMS Ex. 21 at 22; Tr. at 102.  The admission summary (also referred to in some documents and by some witnesses as a history and physical) in evidence bears the initials “DM,” the word “Reviewed,” and the date September 12, 2013.  CMS Ex. 21 at 24; P. Ex. 13 at 3.  The Medical Director for Petitioner at the time of Resident 8’s admission on September 9, 2013, was David Martin.  Tr. 426.  Dr. Martin agreed when questioned by the surveyors that the initials on the document were his.  Tr. at 106.  According to Nurse Frost, Petitioner’s usual practice when receiving a history and physical (the admission summary) for a resident is to place it in the resident’s records and “someone will review it, a doctor or our nurse practitioner.”  Tr. at 471.  The facts that:  (1) the surveyors retrieved the admission summary from Resident 8’s records; and (2) the summary was initialed by Dr. Martin on September 12, 2013, three days after the resident’s admission; and (3) the testimony of Nurse Frost regarding the usual treatment of such documents; establishes it is more likely than not that the admission summary listing a Macrodantin® allergy was in Petitioner’s clinical record for Resident 8 as early as September 12, 2013.
 
A nursing admission information form dated September 9, 2013, lists allergies to codeine, influenza vaccine, Elavil®, Darvocet®, and Tussionex®.  Noted in a different handwriting are allergies to Macrodantin®, Ultram®, and PCN (penicillin) and that entry is dated March 27, 2014, with the initials SEC, indicating that entry was added on March 27, 2014.  CMS Ex. 21 at 34, 77; P. Ex. 10 at 1; Tr. at 442-43, 454, 466-67.  ADON Cook testified that Macrodantin® was not listed on either the nursing admission information form dated September 9, 2013 (CMS Ex. 21 at 34, 77; P. Ex. 10 at 1) or the record of admission (face sheet) (P. Ex. 5; CMS Ex. 21 at 76) and she added Macrodantin® on about March 27, 2014, which was during the survey as part of an audit directed by the administrator.  Tr. at 576-78, 587-89.  Nurse Frost also forthrightly admitted that Petitioner’s nursing admission information form for Resident 8, also most likely prepared at the time of her admission, failed to list her allergy to penicillin (P. Ex. 10 at 1; CMS Ex. 21 at 77), despite the fact that the allergy was listed on the Discharge Medication Orders Petitioner received at about the time of the resident’s admission (CMS Ex. 21 at 25).  Tr. 468-69.  The testimony of Nurse Frost and ADON Cook shows that the

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accuracy of Petitioner’s records related to Resident 8 is clearly suspect.  I also note that pages from Resident 8’s medication administration record (MAR) list no allergies in the blocks designated for listing allergies.  CMS Ex. 21 at 51-57, 66-73, 90-95.  A physician order form that shows it was reviewed on September 9, 2013, lists allergies to codeine, penicillin, Darvocet®, Tussionex®, and Macrodantin® but omits the influenza vaccine, Ultram®, and Elavil®.  CMS Ex. 21 at 50.  Another version of this form, also reviewed on September 9, 2013, did not list either Macrodantin® or influenza vaccine.  CMS Ex. 21 at 154-55.  A version of the same form reviewed on February 14, 2014, listed codeine, penicillin, Darvocet®, Tussionex®, influenza and pneumonia vaccines, and tuberculosis serum, but not Macrodantin®.  CMS Ex. 21 at 167-71.  These errors in Petitioner’s records also show that the accuracy of Petitioner’s records for Resident 8 is clearly suspect.

On March 8, 2014, Resident 8’s physician ordered that she be started on Macrobid®,9  twice per day by mouth for ten days.  CMS Ex. 21 at 42, 106; P. Ex. 11; Tr. at 450-51.  Macrobid® was ordered discontinued on March 11, 2014, at 9:50 p.m. and Solu-medrol® and Benadryl® were ordered in response to a possible allergic reaction.  CMS Ex. 21 at 42, 147; P. Ex. 11 at 1-3.  Petitioner prepared an Incident/Occurrence Investigation form dated March 11, 2014.  The form explains that from March 8 to March 11, 2013, Resident 8 received eight doses of Macrobid® and then had a possible allergic reaction that included a feeling of chest tightness.  Resident 8 reported that she had a previous allergic reaction to Macrodantin® but that allergy was not listed in the resident’s history.  The resident’s physician, Dr. Martin, was contacted and he ordered that the Macrobid® be discontinued and that Resident receive Solu-Medrol® and Benadryl® to address the allergic reaction.  CMS Ex. 21 at 37-38, 187-88; P. Ex. 12 at 15.  Nurse Frost was interviewed as part of Petitioner’s investigation, and she stated she reviewed medications and allergies with Resident 8 when she was admitted and the resident did not mention an allergy to Macrodantin®.  Nurse Frost also stated that Resident 8 did not mention an allergy when Nurse Frost gave her Macrobid®.  CMS Ex. 21 at 38, 187.  Nurse Frost testified that when she gave Resident 8 the prescribed Macrobid®, she told Resident 8 that it was Macrodantin® and Resident 8 said nothing about being allergic.  Tr. at 452-53.  I find Nurse Frost’s testimony that she told Resident 8 that she was giving her Macrodantin® rather than Macrobid® is not credible.  Whether or not Resident 8 would know the difference between Macrodantin® and Macrobid® is highly questionable and an inference I am not willing to draw.  The physician order was specifically for Macrobid® and the prior order for the generic form of the antibiotic was specifically withdrawn by the physician at the same time that the order for Macrobid® was given.  P. Ex. 11 at 1.  Therefore, it is more likely than not that Nurse Frost would have specifically

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referred to Macrobid® rather Macrodantin®, which Petitioner’s witness Nurse Wentzler testified are different formulations.  Tr. at 494.  If Nurse Frost told Resident 8 that she was being given Macrobid®, I have no evidence to support a finding that Resident 8 would have recognized that that antibiotic included the same active ingredient as Macrodantin® or the same risk for an allergic reaction or sensitivity.  My evaluation is supported by the fact that on March 11, 2013, when Resident 8 reported chest tightness she recalled that she was allergic to Macrodantin®.  CMS Ex. 21 at 37, 188.  Furthermore, the nurse notes that document the incident refer only to Macrobid®.  P. Ex. 12 at 15-16.

There is evidence that Resident 8’s reaction to Macrobid® may have reflected a sensitivity rather than an allergic reaction.  P. Ex. 17 at 1-2; Tr. at 501-04.  Petitioner did not offer Dr. Martin, the treating physician of Resident 8, or any expert in allergy and immunology who could explain the difference or why one might be considered harmful to the resident while the other is not.  Tr. 505-10.  The evidence presented shows that the resident experienced chest tightness, she complained and told staff that she had a history of reaction to Macrodantin®, and Dr. Martin ordered medications appropriate for treatment of a possible allergic reaction that provided the resident relief.  P. Ex. 12 at 15-16.  On the facts of this case, I conclude that any distinction between an allergic reaction and sensitivity to a drug has not been established.  Whether the tightness in the chest Resident 8 experienced was a symptom of anxiety (Tr. 509-10) or other process, it clearly was distressing enough for the resident to complain, supporting my inference that she suffered harm.  I also note that Resident 8’s complaint of chest tightness is consistent with known side effects of Macrodantin®; whether or not those side effects are properly characterized as an allergic reaction or a sensitivity need not be resolved.  P. Ex. 7.

Petitioner had a policy for dealing with medication discrepancies.  CMS Ex. 29.  Petitioner’s policy provided that such discrepancies “are documented and reported to the resident’s attending physician, DON, responsible party, and the Performance Improvement Committee.  In addition to reporting discrepancies that result in the patient receiving an incorrect medication, medication discrepancies that have the potential for, but do not actually result in the patient receiving an incorrect medication are documented and reported.”  CMS Ex. 29 at 1.  The policy defines a medication discrepancy as “[a]n inappropriate or incorrect medication prescribed for, dispensed for, or given to a patient.  It is also an omission of medication due to a prescribing, dispensing or administering error.”  CMS Ex. 29 at 1.

Petitioner’s admissions coordinator, Sheldon Thacker, testified that on two separate occasions, Pikeville Medical Center gave him copies of a referral packet for Resident 8 that included a history and physical for Resident 8 that did not list any allergy to Macrodantin®.  Tr. at 398-407.  Mr. Thacker testified that he had no idea what happened to either copy of the document, and Petitioner’s counsel represented that Petitioner had “turned the building upside down and ha[d] not been able to find it.”  Tr. at 406-07. Mr.

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Thacker’s testimony that the referral documents he received for Resident 8 did not mention an allergy to Macrodantin® is not given weight because the documents that might support giving weight to his testimony were lost or destroyed by Petitioner and not offered as evidence to bolster his testimony.  Further, Mr. Thacker’s testimony in this regard is inconsistent with the admission summary produced by Petitioner that lists Resident 8’s allergy to Macrodantin® that was initialed, dated, and noted to have been reviewed by Dr. Martin on September 12, 2013.  CMS Ex. 21 at 22-24; P. Ex. 13.  Mr. Thacker also testified that he personally kept the medical records he received in referral packets in his office and eventually discarded them, rather than placing them in the residents’ medical records at the facility.  Tr. at 429-30.  He testified that he only received the initial referral packet, not the admissions packet that would have come in when the resident actually enters the facility.  Tr. at 417.10  ADON Cook testified credibly that the referral and admissions packets do not always contain the same information and that the admissions packet likely would include more up-to-date information.  Tr. at 568-69.  She also testified credibly that the care team for a new resident would use the admissions packet “to assist in planning [the resident’s] care.”  Tr. at 569.  Thus, even if Mr. Thacker received a history and physical for Resident 8 that omitted Macrodantin® from Resident 8’s drug allergies list, it is more probably true than not that Petitioner did not use that history and physical for care planning purposes.  According to Mr. Thacker, he would generally have destroyed the referral documents, rather than placing them in the resident’s record where it might have been used by the care planning team.

Dr. Martin was not called by Petitioner to testify at the hearing.  On March 8, 2014, nearly six months to the day after Resident 8’s admission, Dr. Martin prescribed Macrodantin® for Resident 8 to treat a UTI.  There is no documentation that he considered that the resident had reported an allergy to Macrodantin® or that he decided to prescribe the antibiotic despite the reported allergy.  CMS Ex. 21 at 42 (March 8, 2013 prescription for Macrobid®), 49 (March 8, 2013 prescription for nitrofurantoin, the generic form of Macrobid® and Macrodantin®); P. Ex. 11 at 1.  Surveyor Partin interviewed Dr. Martin during the survey, and Surveyor Partin testified, consistent with his interview, that Dr. Martin denied knowing that Resident 8 was allergic to Macrodantin®.  CMS Ex. 21 at 16; Tr. at 110.  Surveyor Sherry Miracle, who was

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present during the interview with Dr. Martin, agreed that he denied knowing that Resident 8 had reported being allergic to Macrodantin® and he stated that Resident 8 “could have had serious consequences up to death from taking Macrodantin®.”  Tr. 177-78.  Surveyor Partin’s and Surveyor Miracle’s testimony is credible.  Dr. Martin’s reported comment about the potentially serious consequences of an allergic reaction is consistent with general information about allergic reactions issued by the National Institutes of Health (NIH) stating that while “[f]irst-time exposure may produce only a mild reaction[, r]epeated exposures may lead to more serious reactions” and while “[m]any allergic reactions are mild, . . . others can be severe and life-threatening.”  CMS Ex. 61 at 4.  Dr. Martin reviewed the history and physical almost six months prior to prescribing Macrodantin® for Resident 8.  If Dr. Martin only reviewed the history and physical section of the admission summary on September 12, 2013, it is not likely, given the fact that he was medical director and primary care physician for several residents, that on March 8, 2014, he remembered reviewing the document or its contents on September 12, 2013.  I infer that when he prescribed Macrobid® on March 8, 2014, Dr. Martin did not recall that the resident had a Macrodantin® allergy.  I also infer that when staff administered the antibiotic after it was prescribed, they did not identify the resident’s allergy.  The error of Dr. Martin and staff is attributable to the fact that Petitioner’s staff failed to enter the allergy on the appropriate documents in the resident’s clinical record after the resident’s admission and prior to the prescription and administration.  Petitioner created a care plan dated December 31, 2013, to address Resident 8’s potential for injury and discomfort due to allergies to various drugs and immunizations but did not list Macrodantin®.  CMS Ex. 21 at 113.  Petitioner’s MAR also listed no allergy to Macrodantin®.  CMS Ex. 21 at 51-57, 66-73, 90-95.

From March 8 through March 11, 2014, Petitioner’s staff administered to Resident 8 seven doses of Macrobid®.  CMS Ex. 21 at 89.  On March 11, 2014, Resident 8 reported tightness in her chest.  According to the NIH literature in evidence, chest discomfort or tightness is a symptom of a moderate or severe allergic reaction.  CMS Ex. 61 at 5.  Resident 8 told Petitioner’s staff she had chest tightness and that she previously had an allergic reaction to Macrodantin®, after which Dr. Martin prescribed Solu-Medrol® and Benadryl® due to a possible allergic reaction, and he ordered that the Macrobid® be discontinued.  CMS Ex. 21 at 37-41.

Petitioner investigated Resident 8’s reaction to Macrobid®.  CMS Ex. 21 at 37-41, 186-89.  The investigation report indicates that Petitioner’s staff assessed that Resident 8 was experiencing a “possible allergic reaction” to Macrobid® after receiving eight11 doses of

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the drug.  CMS Ex. 21 at 37-38, 187-88.  Dr. Martin was notified of the reaction at 9:30 p.m. on March 11, 2014, and Resident 8 was “resting in bed [with] no [signs or symptoms] of distress” after Petitioner’s staff gave her Solu-Medrol® and Benadryl®.  CMS Ex. 21 at 37, 188.  During the investigation, Nurse Frost reported that while she had reviewed Resident 8’s medications and allergies with Resident 8 both on Resident 8’s admission and when administering Macrobid® to Resident 8, Resident 8 never mentioned her allergy to Macrodantin®.  CMS Ex. 21 at 38, 187.  Under “Medication Alerts,” the investigation report lists as “[c]hanges in the last week” the following allergies:  codeine, Tussionex®, Darvocet®, PCN (penicillin and its derivatives), pneumonia vaccine, flu vaccine, and Macrodantin®.  CMS Ex. 21 at 40-41, 189.  The report does not list Elavil® or Ultram® which were listed in the hospital admissions summary as potential allergens.  CMS Ex. 21 at 22; P. Ex. 13.

I find, based on the evidence, that it is more likely than not that only after her reaction to Macrobid® did Petitioner’s staff add to Resident 8’s care plan, her MAR, and other documents her reported allergies to Macrodantin® and several other drugs.  I note that the potential drug allergies appear not to have been added to some of Resident 8’s records even after the reaction to Macrobid®.  The medication administration list was updated to include a Macrodantin® allergy on March 11, 2014, but it was never updated to include Elavil®, influenza vaccine, or Ultram® allergies.  CMS Ex. 21 at 50; P. Ex. 9 at 1.  The nursing admission information was updated to include previously missing allergies to Macrodantin®, Ultram®, and penicillin and its derivatives on March 27, 2014.  CMS Ex. 21 at 34; P. Ex. 10 at 1; Tr. at 577-78.  On or about March 27, 2014, Resident 8’s face sheet was updated to list all her allergies, including a Macrodantin® allergy, whereas before it listed none.12  CMS Ex. 21 at 76; P. Ex. 5; Tr. at 576-77, 587-89.  Resident 8’s care plan addressing her allergies, which was created December 31, 2013, and continued on March 7, 2014, did not list and was not updated to list Resident 8’s documented Macrodantin®, Elavil®, or Ultram® allergies.  CMS Ex. 21 at 113.

b.  Analysis

Section 1819(c)(1)(A)(ii) of the Act requires that a SNF protect its residents and promote their “right to be free from physical or mental abuse, corporal punishment, involuntary seclusion, and any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.”  The Secretary has provided by regulation that a “resident has the right to be free from verbal, sexual,

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physical, and mental abuse, corporal punishment, and involuntary seclusion.”  42 C.F.R. § 483.13(b).  The regulations require that a facility develop and implement written policies and procedures prohibiting mistreatment, neglect, and abuse of residents and the misappropriation of residents’ property.  42 C.F.R. § 483.13(c).

The surveyors alleged in the SOD that Petitioner violated 42 C.F.R. § 483.13(c)(2), (3), and (4).  CMS Ex. 2 at 3.  The gist of the alleged deficiency is that Petitioner possibly neglected Resident 8, when the possible neglect became apparent due to Resident 8’s complaint of a possible allergic reaction to Macrobid®, Petitioner began an investigation, but that investigation failed to identify in Resident 8’s clinical record the admission summary that listed the Macrodantin® allergy (CMS Ex. 21 at 22-24; P. Ex. 13), and Petitioner failed to report the possible neglect to the state agency.  CMS Ex. 2 at 5.  The requirements of 42 C.F.R. § 483.13(c)(2), (3), and (4) are:

(2) The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source, and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency).

(3) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress.

(4) The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

I conclude that Petitioner violated 42 C.F.R. § 483.13(c)(2), (3), and (4) in the example of Resident 8.

The federal regulation requires that all allegations of mistreatment, neglect, or abuse, including injuries of unknown source, be reported immediately to the administrator and other officials in accordance with state law.  42 C.F.R. § 483.13(c)(2).  Where a SNF reasonably should have suspected it has neglected a resident, then, pursuant to 42 C.F.R. § 483.13(c)(2), (4), it must report to the state agency that suspicion and any investigation it undertook based on that suspicion.  See Bergen Reg’l Med. Ctr., DAB No. 1832

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(2002).13  Appellate panels of the Board have also held that, “for reporting allegations of abuse to the state, ‘the salient question is not whether any abuse in fact occurred or whether [a facility] had reasonable cause to believe that any abuse occurred, but whether there was an allegation that facility staff had abused a resident.’”  Britthaven, Inc., d/b/a Britthaven of Smithfield, DAB No. 2018 at 15 (2006) (quoting Cedar View Good Samaritan, DAB No. 1897 at 11 (2003)).

The terms “abuse,” “mistreatment,” and “neglect” are not defined in 42 C.F.R. § 483.13.  Definitions for abuse and neglect are found in 42 C.F.R. § 488.301.  Abuse is the “willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish.”  42 C.F.R. § 488.301.  Neglect is “failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.”  42 C.F.R. § 488.301.  Mistreatment is not defined in the SNF regulations, and I construe the term to have its common meaning.  CMS policy is that “immediately” means as soon as possible but not more than 24 hours after discovery of the allegation.  Injuries of unknown source are those that are unwitnessed by staff; cannot be explained by the resident; and are unusual due to their nature, location, or frequency.  SOM, app. PP, Tag F225.  The applicable Kentucky state law and regulations are not inconsistent with the Act and the Secretary’s regulations, although to the extent there is any conflict, federal reporting requirements take precedence.  See Britthaven, DAB No. 2018 at 15.  Kentucky law defines “abuse” as “the infliction of injury, sexual abuse, unreasonable confinement, intimidation, or punishment that results in physical pain or injury, including mental injury.”  Ky. Rev. Stat. Ann. § 209.020(8) (West 2007).  Neglect is “a situation in which an adult is unable to perform or obtain for himself or herself the goods or services that are necessary to maintain his or her health or welfare, or the deprivation of services by a caretaker that are necessary to maintain the health and welfare of an adult.”  Id. § 209.020(16).  The Kentucky statute requires, in relevant part, that “[a]ny person . . . having reasonable cause to suspect that an adult has suffered abuse, neglect, or exploitation” must report that suspicion “immediately.”  Id. § 209.030(2), (3).  The Kentucky Administrative Regulations provide for the creation of a 24-hour “on-call response system for emergency reporting after normal office hours.”  922 Ky. Admin. Regs. 5:070 § 2(3).

Based on the facts I have found related to Resident 8, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.13(c)(2), (3), and (4)

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because Petitioner failed to report its possible neglect of Resident 8 and investigation of that neglect to the state in contravention of the regulation.  I also conclude that Petitioner’s investigation of the possible neglect was inadequate given it failed to locate the admission summary listing the Macrodantin® allergy in the resident’s clinical record.  As early as September 9, 2013, and no later than September 12, 2013, Petitioner had in its records the admission summary from Resident 8’s hospitalization listing Macrodantin® as a drug to which she reported a potential allergy.  Although the survey does not specifically cite Petitioner for neglect of Resident 8, had Petitioner been cited for that deficiency, it is supported on the current record.  When Dr. Martin prescribed nitrofurantoin and Macrobid® on March 8, 2014 (CMS Ex. 21 at 42, 49), Petitioner had a care plan for Resident 8 addressing potential drug allergies that posed a risk for “injury and discomfort,” and the goal of that care plan was to keep her “free of allergic reaction.”  CMS Ex. 21 at 113.  Petitioner recognized that it needed to “[m]ake sure [the] resident’s allergies are well documented throughout the chart, medication records, and all other pertinent documents” and that it also needed to “[m]ake sure that all necessary staff members are alerted to [the] resident’s allergies.”  CMS Ex. 21 at 113.  Nevertheless, Petitioner inexplicably failed to identify the admission summary that listed a potential Macrodantin® allergy.  Ultimately, Petitioner administered that antibiotic to Resident 8 without alerting Dr. Martin of the potential allergy.  Furthermore, Petitioner inconsistently documented Resident 8’s allergies to Ultram®, penicillin and its derivatives, Elavil®, and influenza vaccine.  CMS Ex. 21 at 22-25, 34, 40-41, 50, 76, 113, 154-55, 167-71, 189; P. Exs. 5; 6; 9 at 1; 10 at 1; 13 at 1; Tr. at 82-84, 204-05, 442-43, 469, 498, 501.  Petitioner initially failed to include Resident 8’s documented allergies to Ultram®, Elavil®, and Macrodantin® on Resident 8’s medication administration list and care plan.  CMS Ex. 21 at 113, 154-55.  Petitioner’s failure to accurately and completely list drugs for which Resident 8 reported a possible allergy persisted even after Resident 8 had a reaction when Petitioner gave her Macrobid® and Petitioner assessed that it was likely due to an allergy to the drug.  For example, Petitioner only updated her medication administration list with her Macrodantin® allergy, not her Ultram® or Elavil® allergies, after Resident 8 had a reaction.  CMS Ex. 21 at 50.

Had Petitioner’s investigation been adequate, Petitioner should reasonably have found the admission summary and recognized it had neglected Resident 8 by failing to provide her the goods and services necessary to avoid physical harm from a possible allergic reaction despite recognizing that she needed care specifically to avoid such harm.  The evidence also shows Petitioner’s investigation was inadequate because Petitioner had multiple other records relating to Resident 8’s drug allergies that inconsistently documented various other drug allergies.  However, Petitioner’s investigation failed to uncover these obvious problems.  I conclude that Petitioner consequently failed to recognize its systematic neglect of Resident 8’s care needs.  As in Bergen, these pervasive documentation errors coupled with the Macrobid® reaction and subsequent investigation “should reasonably have raised a suspicion that [Petitioner] had neglected its obligation to ensure [Resident 8’s] safety” and, “in effect, [constitutes] an alleged violation that

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should have been reported to the state agency ‘immediately’” pursuant to 42 C.F.R. § 483.13(c)(2), along with the results of Petitioner’s investigation, pursuant to 42 C.F.R. § 483.13(c)(4).  DAB No. 1832.

Petitioner’s neglect of Resident 8 caused actual harm to the resident in the form of discomfort caused by her reaction to Macrobid®, which Petitioner administered to her.  Its failure to report that possible neglect and the results of the investigation posed a risk for additional harm to Resident 8, because Petitioner continued to neglect Resident 8 by failing to ensure that all of her documented allergies were consistently listed on all relevant medical records.

Petitioner argues that it did not violate 42 C.F.R. § 483.13(c)(2), (3), and (4) with respect to Resident 8.  Petitioner argues that “a single nursing error is not necessarily ‘neglect.’”  P. Br. at 22; P. Reply at 18.  Petitioner’s argument is unsupported by either the facts or the law.  Furthermore, this case does not involve just a single nursing error, but rather a systematic failure to ensure that Resident 8, a resident whom Petitioner assessed as needing a specific care plan to treat her drug allergies, had all of her drug allergies documented fully and accurately throughout her medical records.14

Petitioner argues that it must not have had the hospital admission summary listing the Macrodantin® allergy in its records upon Resident 8’s admission because if it had that document at admission, then that would mean its staff “inexplicably disregarded” it.  Petitioner claims there is no evidence to support this assertion and that it is illogical and would only be supportable by “a series of implausible inferences.”  P. Reply at 4, 6-7.  I find no illogic to the proposition that Petitioner’s staff overlooked one of Petitioner’s documented allergies (to Macrodantin®) when it copied information from Pikeville Medical Center records to its own records.  Petitioner’s nursing staff did exactly that when they failed to list Resident 8’s documented allergy to Ultram® in Resident 8’s nursing admission information (which also did not list Petitioner’s allergy to penicillin and its derivatives), medication administration list, and care plan for dealing with allergies.  CMS Ex. 21 at 34; P. Ex. 10 at 1.  It is not illogical to think they overlooked other documented allergies, especially when those allergies were not even consistently

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documented by Pikeville Medical Center.  CMS Ex. 21 at 25-33, 113; P. Exs. 6; 13 at 1; 14 at 1.  In any event, even assuming Petitioner did not have in its records on September 9, 2013, Resident 8’s history and physical listing a Macrodantin® allergy, it had the history and physical in its records no later than three days later, on September 12, 2013, when Dr. Martin reviewed, dated, and initialed the document.

Petitioner cannot deny that it had in Resident 8’s medical record at the time of the survey the hospital admission summary listing a Macrodantin® allergy, because a copy was obtained by the surveyors during the survey.  Petitioner suggests it is plausible that Dr. Martin was the source of the copy of the admission summary and that he filed it in Resident 8’s medical records at the facility.  Petitioner argues that it is unclear when the history and physical was actually added to Resident 8’s records.  Petitioner supports its arguments with nothing but speculation, apparently attempting to shift responsibility for neglecting to identify the document onto Dr. Martin in his role as Resident 8’s doctor, conveniently overlooking that Dr. Martin was part of Petitioner’s staff because he was Petitioner’s medical director.  P. Br. at 12-13; P. Reply at 7-8.

Petitioner’s arguments and evidence do not convince me that it is more likely than not that Petitioner complied with 42 C.F.R. § 483.13(c)(2), (3), and (4), or that its violation of those requirements did not pose a risk for more than minimal harm to its residents.  Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.13(c)(2)-(4) and the violation posed a risk for more than minimal harm; Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

6.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(m)(2) (Tag F333).

7.  The violation of 42 C.F.R. § 483.25(m)(2) (Tag F333) posed a risk for more than minimal harm and amounted to noncompliance.

8.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

a.  Facts

The facts found under Conclusions of Law 1 through 5 are applicable to Conclusions of Law 6 through 8.

b.  Analysis

Long-term care facilities participating in Medicare must ensure that each resident is provided and receives “the necessary care and services to attain or maintain the highest

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practicable physical, mental, and psychosocial well-being, in accordance with the [resident’s] comprehensive assessment and plan of care.”  42 C.F.R. § 483.25.  Regarding medication errors, the quality of care regulations require that the facility must ensure that:

(1) It is free of medication error rates of five percent or greater; and
(2) Residents are free of any significant medication errors.

42 C.F.R. § 483.25(m).

According to the SOM,15 app. PP, Tags F332 and F333, a medication error is the “observed preparation or administration of drugs or biologicals” not in accordance with:  physician’s orders, manufacturer’s specification, or accepted professional standards and principles applicable to the professional preparing or administering of the drug or biological.  The SOM instructs surveyors that a significant medication error is one that causes a resident discomfort or jeopardizes his or her health or safety.  The term “jeopardizes” is not defined in the SOM.  The common meaning of “jeopardize” is “to expose to danger or risk” or to “imperil.”16 The Board has stated that it is not necessary for CMS to show that there was any actual harm to support a conclusion that a medication error is significant.  Rather, a medication error may be significant if there is a potential danger or risk to a resident’s health and safety.  Life Care Ctr. of Tullahoma, DAB No. 2304 at 35 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sebelius, 453 F. App’x 610 (6th Cir. 2011).  Discomfort may depend upon the individual resident.  The relative significance of medication errors is a matter of professional judgment that considers three factors:  (1) resident condition; (2) drug category; and (3) frequency of the error.  The SOM includes a list of medication errors and characterizes them as significant or non-significant.  Macrodantin® is not listed.  Thus, there is no presumption that a medication error related to the administration of Macrobid® is either significant or non-significant.  SOM, app. PP, Tags F332 and 333.

The surveyors alleged in the SOD and CMS charges that Petitioner violated 42 C.F.R. § 483.25(m)(2) and that the violation posed immediate jeopardy.  The elements of the

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CMS prima facie case under 42 C.F.R. § 483.25(m)(2) are that:  (1) a medication error occurred, (2) the medication error was significant, and (3) the error had the potential for causing more than minimal harm.  Petitioner contests all three of these elements, necessitating a closer look at each.

I conclude first that CMS has made a prima facie case that Petitioner committed a medication error.  Although Petitioner’s staff administered Macrobid® pursuant to Dr. Martin’s order, staff failed to identify from Resident 8’s clinical record that she had reported an allergy to Macrodantin®; failed to note the allergy on documents such as the care plan, the MAR, and Petitioner’s record of admission for the resident; and failed to alert Dr. Martin to the reported allergy.  Dr. Martin admitted that giving Resident 8 Macrodantin® could have caused “serious consequences up to death.”  Tr. at 177; CMS Ex. 61 at 4.  According to Petitioner’s policy for dealing with medication discrepancies, Petitioner should have recognized and reported to Dr. Martin Resident 8’s reported medication allergies that might lead to inappropriate prescriptions, before Dr. Martin prescribed Macrobid® and nitrofurantoin for Resident 8.  Thus, the preponderance of the evidence supports the conclusion that Petitioner committed a medication error when it administered Macrobid® to Resident 8.

CMS has also made a prima facie case that the medication error was significant and had the potential for causing more than minimal harm.  There is no real dispute that Resident 8 complained of chest tightness, which is a form of discomfort, because Petitioner gave her Macrobid®.  On March 11, 2014, after receiving seven doses of the drug, Resident 8 reported tightness in her chest and told Petitioner’s staff about her past allergic reaction to Macrodantin®, and her report was consistent with the hospital admission summary, which I have found was in her clinical record at Petitioner.  CMS Ex. 21 at 22, 37.  The evidence shows that Petitioner’s staff suspected Resident 8 was having a possible allergic reaction and contacted Dr. Martin, who prescribed Solu-Medrol® and Benadryl® to treat the perceived allergic reaction.  CMS Ex. 21 at 37-42.  Petitioner’s staff later updated some of its records for Resident 8 to list an allergy to Macrodantin®.17  CMS Ex. 21 at 34, 50, 76.  Thus, not only did administration of the drug pose a risk for serious health consequences (even death, according to Dr. Martin), it actually caused discomfort to Resident 8 in the form of chest tightness, a recognized symptom of moderate to severe allergic reaction.  CMS Ex. 61 at 5.  The preponderance of the evidence supports the

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conclusion that Petitioner’s medication error was significant and had the potential to cause more than minimal harm.

Petitioner’s arguments and evidence to the contrary do not support a different conclusion.  There is some overlap in Petitioner’s arguments regarding Tag F333 and Tag F225, and I only address here arguments I have not already addressed under Tag F225.  Petitioner argues that it did not commit a significant medication error, or an error at all, because it gave Resident 8 Macrobid® in accordance with her doctor’s order and did not violate accepted professional standards in doing so.  P. Br. at 23, P. Reply at 2, 17.  This argument is without merit.  Petitioner had a copy of the hospital admission summary for Resident 8, which Dr. Martin reviewed in September 2013, shortly after the resident’s admission to Petitioner.  Petitioner’s staff failed to ensure that Resident 8’s reported allergy was added to various documents throughout her clinical record to ensure that the care planning team and staff were aware of the reported allergy.  When Dr. Martin ordered nitrofurantoin and then Macrobid®, the evidence convincingly shows that no staff member was aware of the potential allergic reaction or advised Dr. Martin of the conflict between his order and the resident’s clinical record.  Therefore, no attempt was made to resolve the conflict, and Resident 8 was given an antibiotic that jeopardized her life.  Petitioner has failed to show by a preponderance of the evidence that the errors and omissions of Petitioner’s staff do not violate any reasonable standard of practice.  I conclude that there was a medication error and that it was significant.  The fact that staff was following a physician’s order is no defense on the facts of this case.

Petitioner tries to shift the blame to Resident 8, arguing that the resident did not report she was allergic to Macrodantin® either at admission or when nurses began administering Macrobid® to her.  P. Reply at 5.  Pursuant to 42 C.F.R. § 483.25, Petitioner by participating in Medicare agrees and is obligated to ensure that a resident receives “the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”  In this case, Petitioner had the hospital admission summary but failed to include the reported Macrodantin® allergy in its comprehensive assessment and care planning for Resident 8.  Whether or not Resident 8 reported the prior reaction to the antibiotic is no excuse for Petitioner’s failure to identify and care plan for the reported allergy given Petitioner’s possession of the hospital admission summary.  Further, the evidence shows that the prescription was for nitrofurantoin initially and was then changed to Macrobid®.  I found not credible Nurse Frost’s assertions that she told Resident 8 when administering the Macrobid® that it was Macrodantin®.  Petitioner has not shown that Resident 8 would have recognized that Macrobid® and Macrodantin® are essentially the same antibiotic or understood that the risk of an allergic reaction was the same for each.  Even if Nurse Frost actually told Resident 8 that the drug being administered was Macrodantin®, the evidence does not show how lucid the resident was at the time or that she understood that she was being advised of the name of the drug so that she could object that it might cause an allergic

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reaction or otherwise cause her harm.  Given the nuances of dealing with elderly nursing home populations, relying upon them to object to the administration of medication is simply not acceptable practice.  The responsibility for resident care is upon the SNF, not the residents, and Petitioner has presented no legal authority or standard of practice that indicates the contrary.

Petitioner has failed to show that it is more likely than not that it was in substantial compliance with 42 C.F.R. § 483.25(m)(2), or that its violation of the regulation did not pose a risk for more than minimal harm to its residents.  Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(m)(2) and the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

9.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.60(c) (Tag F428).

10.  The violation of 42 C.F.R. § 483.60(c) (Tag F428) posed a risk for more than minimal harm and amounted to noncompliance.

11.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

a.  Facts

The facts found under Conclusions of Law 1 through 5 are applicable to Conclusions of Law 9 through 11.

b.  Analysis

The regulation requires that the drug regimen of each resident be reviewed “at least once a month by a licensed pharmacist” who “must report any irregularities to the attending physician and the director of nursing, and [reported irregularities] must be acted upon.”  42 C.F.R. § 483.60(c).  The surveyors alleged in the SOD that the regulation was violated based on Petitioner’s pharmacist failing to determine that  Resident 8 was allergic to Macrodantin®, as documented in the hospital admission summary in Resident 8’s clinical record, and “failed to inform the resident’s attending physician and the Director of Nursing (DON) of the resident’s allergy.”  CMS Ex. 9 at 85-86.

Based on the facts I have found related to Resident 8 set forth above, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.60(c) because Petitioner’s pharmacist failed to conduct a thorough enough review of Resident 8’s clinical record to discover the admission summary and report Resident 8’s Macrodantin® allergy to Dr. Martin and the DON, before Dr. Martin prescribed and the

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resident received seven doses of Macrobid®.  Annette Wenzler, Petitioner’s chief nurse executive, testified that the pharmacist was supposed to review all information in a resident’s medical record.  Tr. at 500-501.  The evidence shows it is more likely than not that the reviewing pharmacist did an inadequate review of Resident 8’s clinical record.  I note that the pharmacist also failed to recognize and report irregularities related to Resident 8’s various other medication allergies that were documented inconsistently throughout her clinical records, including her MARs and care plan.  Indeed, the pharmacist’s failure in this regard brings into question the adequacy and thoroughness of all of his reviews of Resident 8’s records and those of other residents.  The pharmacist’s failure contributed to the risk of harm Dr. Martin’s nitrofurantoin and Macrobid® prescriptions posed to Resident 8, and it also contributed to the actual harm Resident 8 suffered (chest tightness) from taking the drug.

Petitioner’s arguments that there was no noncompliance are without merit.  Some of Petitioner’s arguments have already been discussed under the prior deficiencies and there is no need to repeat them here.  Petitioner argues that the regulation does not impose a “zero tolerance” standard of practice for pharmacists or require them to review all medical records for every resident.  P. Br. at 23-24, P. Reply at 18-19.  This argument is clearly without merit.  The regulation requires monthly review and reporting of any irregularities.  42 C.F.R. § 483.60(c).  The regulation does not state that it is acceptable to not review the entire record or to miss some irregularities.  In fact, Petitioner’s chief nurse executive was clear in her testimony that the pharmacist is expected to review the entire clinical record.  Tr. at 500.  The evidence shows that if the pharmacist had done a thorough review of Resident 8’s clinical record, he should have seen the hospital admission summary listing Macrodantin® as a drug to which Resident 8 was allergic so that he could ensure that the potential allergy was listed on the MAR, the care plan, and other documents in the record that direct the delivery of care for the resident.

Petitioner also blames the pharmacist for the violation of 42 C.F.R. § 483.60(c) and argues that CMS has not shown, nor could it show, that the regulation imputes liability for the pharmacist’s error to Petitioner.  Accepting this argument would eviscerate any responsibility of a SNF to ensure that it complies with the regulation, as the SNF could always blame any violation of 42 C.F.R. § 483.60(c) (aside from outright failure to employ or obtain the services of a licensed pharmacist) on the pharmacist to escape liability.  Many appellate panels of the Board have rejected similar arguments by other facilities who have attempted to avoid liability for regulatory violations committed by the individuals those facilities hired or contracted to care for its residents.  See, e.g., Kindred Transitional Care & Rehab – Greenfield, DAB No. 2792 at 11-15 (2017) (collecting cases); Springhill Senior Residence, DAB No. 2513 at 14 (2013) (“Electing to meet its commitments to provide care and protect residents’ rights through these employees, [a facility] cannot . . . reasonably claim that their misconduct [i]s in effect irrelevant for the purpose of evaluating the facility’s compliance.”); Gateway Nursing Ctr., DAB No. 2283 at 8 (2009) (holding that a facility “acts through its staff and cannot disown the

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consequences of the actions of its employee”); North Carolina State Veterans Nursing Home, Salisbury, DAB No. 2256 at 12 (2009) (“The rationale for holding a facility accountable for the actions of its staff applies equally to all staff members who . . . fail to act in a manner consistent with the regulations and the facility’s policies . . . .”).18  Petitioner, by participating in Medicare, agrees that services provided or arranged by the facility must meet professional standards of quality and be provided in accordance with the resident’s care plan.  42 C.F.R. §§ 424.510(d)(3), 483.20(k)(3).  Under 42 C.F.R. § 483.60(c), Petitioner was required to ensure that a licensed pharmacist reviewed each resident’s drug regimen monthly and reported any irregularities to the attending physician and DON.  But in this case the pharmacist Petitioner used to conduct such reviews did not report irregularities reflected in Resident 8’s clinical record related to drug allergies to Dr. Martin and the DON.  Petitioner cites no legal authority for avoiding responsibility for the regulatory violation caused by its contract pharmacist.

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.60(c) and the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

12.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75(o) (Tag F520).

13.  The violation of 42 C.F.R. § 483.75(o) (Tag F520) posed a risk for more than minimal harm and amounted to noncompliance.

14.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

a.  Facts

The facts found under Conclusions of Law 1 through 5 are applicable to Conclusions of Law 12 through 14.

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b.  Analysis

Every long-term care facility is required to establish a functioning quality assessment and assurance (QA) committee.  The regulation requires:

(1) A facility must maintain a quality assessment and assurance committee consisting of—

(i) The director of nursing services;
(ii) A physician designated by the facility; and
(iii) At least 3 other members of the facility’s staff.

(2) The quality assessment and assurance committee—

(i) Meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary; and
(ii) Develops and implements appropriate plans of action to correct identified quality deficiencies.

42 C.F.R. § 483.75(o)(1)-(2).

There is no question that Petitioner had a QA committee as required by the regulation.  The deficiency cited by the surveyors alleges that the QA committee was ineffective in identifying quality deficiencies and developing and implementing appropriate plans of correction related to Petitioner’s system for dealing with resident drug allergies.  CMS Ex. 9 at 119-20.  This deficiency citation is derivative of the deficiencies I have already discussed.

Based on the facts I have found related to Resident 8, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75(o) because Petitioner’s QA committee failed to:

• Identify and implement an effective plan of action to address Petitioner’s possible neglect of Resident 8’s medical needs related to her drug allergies; and
• Ensure that it had effective processes in place, including a qualified reviewing pharmacist, to ensure all potential drug allergies identified in the clinical record were included in care plans and listed in documents used by staff in delivering care.

In layman’s terms, Resident 8’s records related to her drug allergies were a mess, riddled with incomplete and inaccurate documentation of her numerous drug allergies.

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Furthermore, even a cursory review of Resident 8’s records would have revealed significant deficiencies related to identification of reported drug allergies for which the QA committee should have developed and implemented a plan to correct.  Even if I accepted that the QA committee had no reason to suspect a problem prior to Resident 8 receiving Macrobid® (despite her records showing she was allergic to the drug), the investigation of that incident should have identified the problem for the QA committee to address.  This deficiency posed a risk for more than minimal harm to Resident 8 and all residents with a history of reported drug allergies.  I conclude that CMS has made a prima facie showing that Petitioner’s violation of 42 C.F.R. § 483.75(o) created a risk of more than minimal harm.

Petitioner has failed to rebut the CMS prima facie case or establish substantial compliance or an affirmative defense by a preponderance of the evidence.  Petitioner has presented no evidence that its QA committee was aware of the possible neglect of Resident 8’s drug allergy care needs.  The testimony of Petitioner’s witnesses was that they were not aware of her Macrodantin® allergy until after she suffered an adverse reaction to the drug, and even after that, Petitioner’s staff failed to ensure that all of Resident 8’s allergies were documented fully and consistently throughout her medical records.  Tr. at 498, 501.  This was clearly a matter to be addressed by the QA committee to ensure quality of care for Resident 8 and all residents with possible allergies to medications.

Petitioner’s arguments to the contrary are unpersuasive.  Petitioner argues generally that CMS has not shown that its allegations related to Resident 8 implicate the quality assurance requirements found in 42 C.F.R. § 483.75(o).  P. Br. at 24, P. Reply at 19-20.  Petitioner recognizes “that the Board has held that there may be cases where a ‘systemic’ breakdown of clinical policies or procedures allows an inference that the facility’s Administrator and [QA] Committee are not performing their functions effectively” but argues that such an inference cannot be drawn from every nursing or pharmacy error.  P. Br. at 24.  Petitioner also argues that nothing in the SOD gives any reason to believe that its QA committee was required to know about all documents relating to every resident or that its QA committee had an obligation to perform a document-by-document review of Resident 8’s records at any time.  P. Br. at 24.  I agree with Petitioner that there is no requirement that its QA committee review every document in every clinical record for every resident.  But that is not the deficiency alleged here.  The deficiency, in my view, is that Petitioner’s QA committee failed to identify and implement an effective plan of action to address Petitioner’s possible neglect of Resident 8’s medical needs related to her drug allergies and failed to ensure that it had effective processes in place, including a qualified reviewing pharmacist, to ensure all potential drug allergies identified in the clinical record were included in care plans and listed in documents used by staff in delivering care.

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Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75(o), the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

15.  The declaration of immediate jeopardy related to the noncompliance cited based on violations of 42 C.F.R. §§ 483.13(c)(2)-(4); 483.25(m)(2); 483.60(c); and 483.75(o) was not clearly erroneous.

The surveyors concluded that the violations of 42 C.F.R. §§ 483.13(c)(2)-(4); 483.25(m)(2); 483.60(c); and 483.75(o) posed immediate jeopardy that began March 8, 2014 (CMS Ex. 2 at 5, 50-51, 86, 121) and was abated on March 31, 2014 (CMS Ex. 2 at 2; CMS Ex. 5 at 1).  CMS proposes to impose a CMP in the higher range of CMPs that may be imposed for immediate jeopardy from March 8, 2014 through March 30, 2014 (Jt. Stip. ¶ 6), and that is the period of immediate jeopardy at issue before me related to the April 3, 2014 survey.

Petitioner bears a heavy burden under the regulations when challenging a declaration of immediate jeopardy.  Unlike the issue of whether there is noncompliance, the Secretary has by regulation imposed the burden of persuasion on Petitioner to show that the declaration of immediate jeopardy was in error not by a preponderance of the evidence, but by the clearly erroneous standard.  The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).

CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro,DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005)), aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs., 174 F. App’x 932 (6th Cir. 2006); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnson v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).  “Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous.”  Cal Turner, DAB No. 2384 at 14-15 (citing Liberty Commons, 241 F. App’x 76, at 80-81).

“Immediate jeopardy” under the regulations refers to “a situation in which 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, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement

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related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(ii).

Many appellate panels of the Board have addressed “immediate jeopardy.”19  In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031, at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.”  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  Daughters of Miriam Center, DAB No. 2067, at 15 (2007).

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The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994) (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Ctr. of

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Greenville, Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Ctr. of Greenville,that panel of the Board states that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  DAB No. 2450 at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Ctr. and other cases does not define the standard.  The “clearly-erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black’s Law Dictionary 269 (8th ed. 2004).  The Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring); Concrete Pipe & Products of California, Inc. v. Construction Laborers, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consolidated Edison Co. of New York v. Nat’l Labor Relations Bd., 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. United States Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA

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requires meaningful review.20  Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19, (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff’d, Life Care Ctr. of Tullahoma v. Secretary of U.S. Dep’t of Health & Human Servs., 453 F. App’x 610).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health and Rehab./Goldsboro, DAB No. 2336 at 7-8.  There is a difference between “likelihood” as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences.  Woodstock Care Ctr., DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm?”  On the first question the Board recognized in Yakima Valley Sch., DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.21  The

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Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.”  Id. (citing Daughters of Miriam Ctr.,DAB No. 2067 at 9).  In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  Daughters of Miriam Ctr.,DAB No. 2067 at 9-10.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found, I have no definite and firm conviction that an error has been committed either by the declaration of immediate jeopardy or the period of immediate jeopardy from March 8, 2014 through March 30, 2014.  Petitioner repeatedly failed to document accurately and completely all of Resident 8’s drug allergies, to Macrodantin® and other drugs.  Specifically with regard to the reported Macrodantin® allergy, Dr. Martin told the surveyors, consistent with information from the NIH, that Resident 8 could have suffered serious side effects or even death from taking Macrodantin®.  Tr. at 177; CMS Ex. 61 at 4.  This failure continued even after Petitioner identified Resident 8’s drug allergies as a problem and created a care plan with interventions intended to mitigate that problem and keep Resident 8 free from allergic reactions.  All four of the cited deficiencies related to Resident 8, reflect the fundamental breakdown in Petitioner’s care for the resident and contributed to the risk of serious harm she faced if Petitioner gave her drugs to which she was allergic.  Petitioner’s good fortune that Resident 8 did not experience more serious symptoms beyond chest tightness when it gave her Macrobid®—a  drug to which she had a documented allergy—does not convince me that

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CMS erred in finding that Petitioner’s noncompliance posed immediate jeopardy to Resident 8.

Petitioner argues that the record does not establish that Resident 8 had an allergy, as opposed to just a sensitivity, to Macrodantin®, and notes that Resident 8 “suffered only ‘chest tightness,’ which apparently was quickly resolved.”  P. Reply at 6 n.7, 26; P. Br. at 9 n.7.  In essence, Petitioner is arguing that simply because Resident 8 suffered no serious side effects from the Macrodantin® and may only have been sensitive, rather than allergic, to Macrodantin®, CMS’s immediate jeopardy citation must be clearly erroneous because Resident 8 did not face a “likelihood” of serious harm.  Petitioner has the burden to establish the declaration of immediate jeopardy was clearly erroneous, but Petitioner offered no qualified expert testimony or significant scientifically-based evidence in support of its argument that there was no immediate jeopardy.  On the facts of this case, expert or other credible scientific or medical evidence would have been required to address whether or not there was truly immediate jeopardy.  The facts show that Resident 8 previously reported an allergic reaction to Macrodantin®, she was given Macrobid®, and during the time she was receiving Macrobid® she experienced chest tightness, a possible symptom of an allergic reaction.  Petitioner did not offer expert testimony to show that:  Resident 8 did not have an allergic reaction, she did not have an allergic reaction to Macrobid®, there is a difference between a sensitivity and an allergy, that the level of discomfort is different as between an allergic reaction and a sensitivity, or that a reaction due to a sensitivity is any more or less serious than an allergic reaction.  The evidence also shows that Resident 8 was treated as if she was having an allergic reaction and that treatment seemed to be effective.  If the same treatment would have been effective to address a sensitivity is not shown by the record.  Many of these issues could have been addressed by Petitioner’s investigation, had it been adequate.

Viewing the record as a whole, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the noncompliance under 42 C.F.R. §§ 483.13(c)(2)-(4) (Tag F225); 483.25(m)(2) (Tag F333); 483.60(c) (Tag F428); and 483.75(o) (Tag F520) during the period of March 8, 2014 through March 30, 2014, was clearly erroneous.

16.  The June 4, 2014 survey determined that the immediate jeopardy declared to have begun on May 24, 2014, was abated as of May 31, 2014; therefore, the period of immediate jeopardy at issue related to the June 4, 2014 survey is May 24, 2014 through May 30, 2014.

17.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.13(c)(2) and (3) (F225).

18.  The violation of 42 C.F.R. § 483.13(c)(2) and (3) posed a risk for more than minimal harm and amounted to noncompliance.

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19.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

Based upon Petitioner’s September request for hearing, the deficiencies at issue before me related to the survey completed on June 4, 2014, are cited as violations of 42 C.F.R. §§ 483.13(c)(2)-(4) (Tag F225); 483.25(c) (Tag F226); 483.75 (Tag F490); and 483.75(o) (Tag F520) and alleged to have posed immediate jeopardy to Petitioner’s residents.

After complete review of the entire record, I conclude that it is only necessary to discuss the example of Resident 32 to determine that Petitioner was in violation of 42 C.F.R. § 483.13(c)(2) and (3) (Tag F225); 483.25(c) (Tag F226); 483.75 (Tag F490); and 483.75(o) (Tag F520) and that there was immediate jeopardy from May 24, 2014 through May 30, 2014 with continuing noncompliance through June 11, 2014.  Therefore, I conclude it is unnecessary to discuss any other examples cited under those deficiency citations.  The facts related to the example of Resident 32 are set forth here but apply equally to the noncompliance cited under Tags F226, F490, and F520.

a.  Facts Applicable to All Deficiency Citations in Issue Related to Resident 32

i.  Petitioner’s Policy Required by 42 C.F.R. § 483.13(c)

Petitioner issued a policy effective April 2013, prohibiting mistreatment, neglect, and abuse of residents and misappropriation of resident property as required by 42 C.F.R. § 483.13(c) (abuse and neglect policy).  CMS Ex. 25 at 5-8; P. Ex. 19.  Petitioner’s abuse and neglect policy required that “[a]ll allegations of abuse involving abuse along with injuries of unknown origin are reported immediately to the charge nurse and/or administrator of the facility along with other officials in accordance with State law through established guidelines.”  CMS Ex. 25 at 5; P. Ex. 19 at 1.  Petitioner’s abuse and neglect policy required that “[a]ll allegations of abuse will be investigated and reported to the appropriate agencies.”  CMS Ex. 25 at 7; P. Ex. 19 at 3.

Petitioner’s abuse and neglect policy included multiple procedures for handling allegations of abuse.  To protect the resident(s) allegedly abused, Petitioner’s staff are to immediately report “[a]ll allegations of abuse . . . to [the] charge nurse,” unless the charge nurse is the suspected perpetrator; the charge nurse must “immediately remove the suspected perpetrator from resident care areas, obtain the staff members witness statement and immediately suspend the employee pending the outcome of the investigation” and must also “immediately notify the Administrator, DON and/or Abuse Coordinator . . . .”  CMS Ex. 25 at 7; P. Ex. 19 at 3.  Further, “[t]he Administrator and/or DON will notify state agencies according to their reporting guidelines.”  CMS Ex. 25 at 7; P. Ex. 19 at 3.  To ensure allegations of abuse are properly investigated, Petitioner’s

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Administrator or designee is instructed by the policy to “make all reasonable efforts to investigate and address alleged reports, concerns, and grievances,” and any “person(s) observing the incident” are instructed to “immediately report and provide a written statement that includes name of resident, date and time incident occurred, where it occurred, staff involved and a description of what occurred . . . .”  CMS Ex. 25 at 8; P. Ex. 19 at 4.

ii.  Resident 32

Resident 32 was 87 years old when admitted to Petitioner on November 29, 2013.  She had a history of recurrent falls, myocardial infarction, dyslipidemia, Alzheimer’s disease with dementia and psychotic features, coronary artery disease, congestive heart failure, atrial fibrillation, gastroesophageal reflux disease, and other ailments.  CMS Ex. 54 at 5-7, 16.  Upon admission, a nursing skin evaluation revealed multiple bruises on Resident 32 and reported that she had a history of bruises.  CMS Ex. 54 at 18, 22.  Shortly after admission, on December 6, 2013, the resident’s care planning team assessed Resident 32 as at risk for skin breakdown and issued a care plan with a goal of keeping her skin intact.  CMS Ex. 54 at 5, 24.  One intervention listed was for staff to notify the nurse immediately if any new areas of skin breakdown, bruises, or similar problems were noted during bathing or daily care.  CMS Ex. 54 at 5, 24.

The record includes an unsworn statement of Certified Nurse Assistant (CNA) Tasha Day taken as part of an investigation of bruises found on Resident 32 on May 24 and 25, 2014.  CNA Day states that on May 24, 2014, she and “Pat” (CNA Pat Tucker) were getting Resident 32 up and they found two bruises on the resident’s left hand and wrist.  CNA Day states that the resident told them that a man had caused the bruises.  CNA Day states CNA Tucker reported to the nurse and night shift CNA.  P. Ex. 20 at 1.  CNA Pat Tucker was interviewed as part of the investigation and she stated that the bruises had been found “yesterday morning,” which I infer to be the morning of May 24, 2014, when she and Tasha Day were getting Resident 32 up.  CNA Tucker stated that the resident told them that a boy had caused the bruises.  CNA Tucker stated that she reported to “Charlotte” who was a nurse on duty at the time.  P. Ex. 20 at 2; CMS Ex. 54 at 56.  The record contains a subsequent written, unsworn statement from CNA Tucker that appears to be dated May 24, 2014, but I find based on the text of the statement was actually prepared sometime after May 25, 2014.  CNA Tucker states that she and CNA Day were getting Resident 32 up on May 24, 2014, and they found two dark purple bruises on the resident’s left arm or wrist.  The resident told her that some boy caused the bruises.  CNA Tucker states that she immediately reported to Licensed Practical Nurse (LPN) Charlotte Fugate and subsequently reported to the CNA on the night shift that bruising was found on the resident.  P. Ex. 23.  LPN Fugate was interviewed and she stated that she had done a skin assessment early Saturday (May 24, 2014) (P. Ex. 21; CMS Ex. 54 at 57) and she did not see bruises on the resident’s left arm and she did not recall CNAs reporting any bruising on Resident 32.  P. Ex. 20 at 2; CMS Ex. 54 at 56.  In an unsworn statement

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dated May 25, 2014, CNA Melena Cantrell stated that CNA Tucker reported to her on May 24, 2014, at 7:00 p.m. that the resident had bruises on her arm.  CNA Cantrell also stated that at 3:30 am on May 25, 2014, she reported the bruises on Resident 32’s arm to unspecified nurses who indicated that they had no knowledge of the bruises.  P. Ex. 20 at 3.  According to the unsworn statements of LPN Sasha McKinney and LPN Valerie Casey, when CNA Cantrell reported bruises on Resident 32’s left wrist they went to the resident’s room to assess the bruises.  They found two bruises, blue in color, on the left forearm or wrist.  The nurses asked the resident who caused the bruises and she reported “Fat Pat” which was understood by staff to refer to CNA Pat Tucker.  P. Ex. 20 at 5-6.

On Sunday, May 25, 2014, RN Connie Day interviewed Resident 32, who told her the bruises happened on Friday, May 23, 2014, when a staff member pulled her up by her arm.  Resident 32 could not identify the staff member by name at the time of the interview.  Subsequently, Resident 32 told RN Day that there were four staff involved who lifted her by her arms.  RN Day concluded that she could not determine the cause of the bruises as the resident’s report was inconsistent with the bruises.  RN Day speculated that the bruises may have been caused by Resident 32’s positioning in her wheelchair and geri-sleeves were ordered to protect the resident’s arms.  P. Ex. 24 at 1.  Nurse notes dated May 25, 2014, at 2:00 p.m. and 10:00 p.m., document that bruises were found on the resident’s wrist or forearm and reflect that geri-sleeves were to be applied every shift as necessary.  CMS Ex. 54 at 15.  Resident 32 refused to be interviewed by DON Stewart on May 27 and 28, 2014.  P. Ex. 26.

The record includes a document that is untitled but appears to be an incident report.  The document indicates it was signed by LPN Sasha McKinney.  The document indicates on the second page that it is a QA document and confidential and privileged.  P. Ex. 25; CMS Ex. 54 at 58-59.  However, the document is offered as evidence by Petitioner, which I treat as a waiver of any privilege.  The document describes the incident involving bruising of Resident 32 and includes the allegation that the bruising was caused by CNA Pat Tucker.  However, the document indicates it was determined that Resident 32 was confused and the bruises were caused by the resident’s positioning in her wheel chair.  Geri-sleeves were ordered to protect the resident’s arms.  The form is undated except to indicate the incident occurred on May 25, 2014, at about 4:00 a.m.  P. Ex. 25; CMS Ex. 54 at 58-59.

DON Stewart documented in an unsworn statement dated May 30, 2014,22 that she was notified on May 25, 2015, at 4:15 a.m. by LPN McKinney of the bruising of Resident 32’s left forearm or wrist.  DON Stewart stated that she was informed that Resident 32

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blamed CNA Pat Tucker.  DON Stewart stated that CNA Tucker was suspended immediately.  CMS Ex. 47 at 11.  The evidence is consistent that CNA Pat Tucker was suspended on May 25, 2014.  P. Ex. 22.  However, DON Stewart states in her May 30, 2014 statement that she determined that the allegation against CNA Tucker was not substantiated and it was more likely that the resident suffered bruising due to positioning in her wheel chair, and geri-sleeves were ordered for her.23  CMS Ex. 47 at 11.  Surveyor Liford testified that she interviewed CNA Tucker at the facility and that CNA Tucker had returned to the facility and worked a shift the day after her suspension.  Tr. at 234.

Petitioner’s Administrator at the time of the incident involving Resident 32, Shawn O’Conner, testified that he was informed of Resident 32’s bruising at around 3:00 a.m. to 4:00 a.m. Central Time on May 25, 2014.  Tr. at 656.  He was not informed immediately that Resident 32 blamed a nurse aide for the bruises, however.  Tr. at 656-58.  It was not until the next day, May 26, 2014, that he was informed that Resident 32 blamed the bruises on Nurse Aide Tucker, but he decided that it was not a reportable allegation because Nurse Aide Tucker did not work on the day that Resident 32 alleged that Nurse Aide Tucker bruised her, and he did not find the resident’s allegation credible.  Tr. at 659.

The incident was eventually reported to the state, but there is conflicting evidence as to the date.  The initial report is signed and dated by DON Stewart on May 28, 2014, and May 28, 2014 is the date on the facsimile transmission sheet.  CMS Ex. 54 at 62-63; P. Ex. 28.  DON Stewart indicates in her five-day follow-up report that the initial report was sent on May 28, 2014.  CMS Ex. 47 at 9-11; P. Ex. 29.  However, DON Stewart’s initial report states that JJ from APS was in the facility on May 27, 2014, and informed the facility that he was investigating an allegation.  CMS Ex. 54 at 63.  The SOD states that an allegation of abuse of Resident 32 was reported to the state agency on May 27, 2014, by the DON.  CMS Ex. 65 at 88.  Although not specifically stated in the SOD, it is possible that the surveyors were referring to an oral report by DON Stewart to JJ from APS on May 27, 2014.  It is not necessary for me to determine exactly when DON Stewart reported the allegation of abuse by Resident 32, as the record supports a finding the report occurred on either May 27 or May 28, 2014.  The SOD indicates that a revisit survey and complaint investigation began on May 28, 2014.  CMS Ex. 64 at 1.  Surveyor Liford, who conducted the complaint survey related to Resident 32, testified that someone filed an anonymous complaint that Petitioner failed to report the incident involving the bruising of Resident 32 to the state.  Tr. at 222, 281-85.  Surveyor Liford testified she cited the deficiency under Tag F520 related to Petitioner’s QA committee and Resident 32.  CMS Ex. 64 at 83-107; Tr. at 277.  She testified that the fact that many

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members of the QA team were involved in daily meetings but failed to recognize that the incident involving Resident 32 had to be reported as abuse was a basis for the deficiency citation under Tag F520.  CMS Ex. 58 at 15; Tr. at 277-80.  Nurse Wenzler explained in testimony that Petitioner’s staff had a daily meeting Monday through Friday, to follow up on every physician order and every change of condition, to ensure care plans were up to date, and to brainstorm to ensure they were providing all the services their residents required.  Tr. at 495-96.  The DON, members of the interdisciplinary team, and sometimes the administrator attended.  Tr. at 496.

b.  Analysis

The requirements of 42 C.F.R. § 483.13(c)(2), (3), and (4) and related cases applying the regulations are discussed in detail in the analysis section following Conclusions of Law 1 through 5, above.  For the reader’s convenience, the regulatory language is set forth again here without the full discussion included above.  The requirements of 42 C.F.R. § 483.13(c)(2), (3), and (4) are:

(2) The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source, and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency).

(3) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress.

(4) The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

The surveyors alleged in the SOD that Petitioner violated these standards by:  failing to report immediately allegations of abuse of Resident 32 to Petitioner’s administrator, the state survey agency, and other officials in accordance with state law; failing to “ensure all allegations were investigated”; and failing to “ensure residents were protected from further potential abuse during the . . . investigation.”  CMS Ex. 64 at 4.  I conclude that Petitioner violated 42 C.F.R. § 483.13(c)(2) and (3) but not (4) in the case of Resident 32.  I conclude there was no violation of 42 C.F.R. § 483.13(c)(4) because the surveyors do

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not specifically allege that Petitioner failed to report the results of its investigation within five working days of the incident or that Petitioner failed to take corrective action.  CMS Ex. 64 at 3-4.  The undisputed facts also show that on May 30, 2014, DON Stewart transmitted by facsimile her five-day report to the state agency.  Whether the alleged abuse of Resident 32 occurred on Saturday, May 24 or Sunday, May 25, 2014, the fifth working day, the required date for submission of the report, was May 30, 2014.  There is no dispute that DON Stewart met the regulatory deadline.

It is the allegation of abuse that triggers the requirements of 42 C.F.R. § 483.13(c)(2)-(4).  A facility is not permitted to first determine whether or not the facility administrator believes that the allegation is founded or substantiated or not.  Britthaven of Smithfield, DAB No. 2018 at 15; Cedar View Good Samaritan, DAB No. 1897 at 11.  In the example of Resident 32, on May 24, 2014, CNAs Day and Tucker found bruises on the resident’s left hand and wrist.  The evidence shows that the resident reported that a man or boy caused the bruises.  P. Ex. 20 at 1.  Petitioner’s abuse and neglect policy required, consistent with 42 C.F.R. § 483.13(c)(2), that injuries of unknown origin were to be reported immediately to the charge nurse and/or administrator and other officials in accordance with state law.  P. Ex. 19 at 1.  Resident 32’s care plan also required that new bruises observed by staff during care were to be reported immediately to the nurse.  CMS Ex. 54 at 5, 24.  According to both CNA Day and CNA Tucker, the bruises on the resident’s left wrist were reported immediately to LPN Fugate.  P. Ex. 20 at 1-2; CMS Ex. 54 at 56; P. Ex. 23.  LPN Fugate denied recalling that CNA Tucker reported the bruising of Resident 32’s left wrist or forearm.  P. Ex. 20 at 2; CMS Ex. 54 at 56.  However, CNA Tucker’s claim that she informed LPN Fugate on May 24, 2014, is consistent with the statement of CNA Cantrell that CNA Tucker told her about the bruising at 7:00 p.m. on May 24, 2014.  CNA Cantrell subsequently reported the bruising to LPN McKinney and/or LPN Casey about 3:00 a.m. on May 25, 2014.  P. Ex. 20 at 3.  I conclude that the violation of 42 C.F.R. § 483.13(c)(2) began upon discovery of the bruises on May 24, 2014, when either CNA Tucker failed to report to the DON and administrator or LPN Fugate failed to immediately report to the DON and administrator.  Furthermore, the facts show a violation of 42 C.F.R. § 483.13(c)(3) because the investigation of the cause of the bruises was delayed and no action was taken between the discovery of the bruises on May 24, 2014, and the first action of LPN McKinney and LPN Casey in response to the allegation of an injury of unknown source on May 25, 2014.  Certainly, upon hearing Resident 32 alleged that CNA Tucker caused the bruises, elevating the allegation to one of abuse or neglect by a staff member, quick action occurred and the evidence shows that DON Stewart immediately suspended CNA Tucker pending investigation.  However, the evidence also shows that CNA Tucker returned to working at the facility before the incident was even reported to the state.  The violation of 42 C.F.R. § 483.13(c)(2) continued because DON Stewart and Administrator O’Conner, who received the report of the incident early on May 25, 2014, failed to immediately report to the state agency.  The regulatory violation continued until DON Stewart actually reported the incident to the state agency on either May 27 or 28, 2014, just as the revisit

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survey and complaint investigation commenced.  Rather than immediately reporting, DON Stewart undertook her investigation concluding that the alleged abuse was not substantiated, choosing not to believe the resident and concluding that the injury was caused by the resident’s positioning in her wheelchair.  The regulation requires an immediate report to the state of an injury of unknown source or an allegation of abuse and does not permit the facility administrator or DON to first determine whether the allegation is substantiated or not.  Petitioner did an investigation as required by 42 C.F.R. § 483.13(c)(3) and that investigation was thorough, and I find no regulatory violation based on the failure to investigate or the thoroughness of the investigation.  The bruises Resident 32 suffered on her left wrist or arm is actual harm, which is more than minimal harm.

Petitioner argues that it did substantially comply with 42 C.F.R. § 483.13(c)(2).  Specifically, Petitioner argues that Resident 32’s allegation falls into a legal “gray area” between a “grievance,” which is not reportable to the state, and an “allegation of abuse,” which is reportable, and that its administrator’s decision to treat the allegation as a non-reportable grievance should be accorded deference.  P. Br. at 15-17, 26-27; P. Reply at 22-23.  In support of this argument, Petitioner asserts that “no federal or Kentucky regulation describes the line between what is a reportable ‘allegation of abuse’ and what sort of complaint is not; nor how an administrator is supposed to make the distinction.”  P. Br. at 15; P. Br. at 24-25; P. Reply at 20-22.24  Using this logic, Petitioner claims that its administrator reasonably exercised his professional judgment to determine that Resident 32’s allegations were a mere non-reportable grievance and did not thereby violate 42 C.F.R. § 483.13(c)(2).  P. Br. at 27; P. Reply at 13-15.

Petitioner’s arguments are unpersuasive for two reasons.  First, the obvious line to draw between a complaint that is a “grievance” and a complaint that is an “allegation of abuse” is whether the complaint includes allegations that a resident was abused.  And although 42 C.F.R. § 483.13 does not itself contain a definition of “abuse,”25 the definition of abuse found in 42 C.F.R. § 488.301 adequately explains what constitutes abuse.  Therefore, the pertinent question a SNF must ask when determining whether to report a

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complaint is whether that complaint involves a claim that a resident was subjected to “willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish.”  42 C.F.R. § 488.301; see Britthaven of Smithfield, DAB No. 2018 at 15.  If the complaint does involve such a claim, it is clearly a reportable allegation of abuse.  The regulation is clear that all allegations involving mistreatment, neglect, or abuse, including injuries of unknown source and misappropriation of resident property, must be reported immediately to the administrator and state.  42 C.F.R. § 483.13(c)(2).

Second, even assuming there is some gray area between “grievances” and “allegations of abuse,” Petitioner’s interpretation would permit SNF staff to decline to report a complaint after exercising professional judgment to categorize the complaint as the former rather than the latter, and this case is nowhere near that gray area.  As I have already described above, Resident 32 initially had an injury of unknown source, and she then made a clear allegation that CNA Tucker willfully inflicted injury or punishment on her that physically harmed her, and might even have caused her pain.  Petitioner’s attempts to obfuscate that allegation by attacking Resident 32’s credibility, listing other circumstances that rendered the allegation less plausible, and even colorfully comparing her allegation to a complaint of abuse by Martians (P. Br. at 26-27; P. Reply at 22) is unavailing and ultimately irrelevant.  Section 483.13(c)(2) of Title 42 does not excuse SNFs from reporting allegations of abuse that are implausible; rather, it requires them to report all allegations of abuse, neglect, and mistreatment.  Resident 32 initially reported different causes of her bruises.  But during the morning of May 25, 2014, she was consistent in her complaints that the bruises on her left wrist and forearm were caused by CNA Tucker.  CMS Ex. 54 at 58-59, 66-71; P. Exs. 20 at 3-7; 24; 25.  One of Petitioner’s own nurses described the incident as “an allegation of abuse.”  CMS Ex. 54 at 71; P. Ex. 20 at 6.

Whatever the merits of Petitioner’s argument in a close case where an incident might reasonably be characterized as a non-reportable grievance rather than an allegation of abuse, its use of that argument in this case, where a resident clearly alleged that a member of Petitioner’s staff abused her, is very troubling.  On these facts, accepting the argument to absolve Petitioner of its obligation to follow its own anti-abuse policy and procedures would eviscerate both the plain language and the clear intent of 42 C.F.R. § 483.13(c).  It would allow SNFs to avoid their responsibility to create and implement anti-abuse policies and procedures that protect their most vulnerable residents by allowing them to characterize obvious allegations of abuse as mere “grievances” and thereby avoid reporting those allegations to the state.  SNFs have an obvious incentive to find there was no resident abuse—to avoid regulatory penalties arising from findings of abuse.  The purpose of the reporting requirement is to ensure that a neutral observer (the state agency) investigates all allegations of abuse made by this vulnerable population.  If SNFs could so easily avoid reporting allegations of abuse to the state, many more instances of resident abuse might go unreported and uninvestigated, to the detriment of all SNF residents.

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Petitioner also complains at some length about an apparent change in state policy in 2013 and 2014 that required it to report to the state a high number of incidents as allegations of abuse, “extending even to ‘a lost sock.’”  P. Br. at 16-17; P. Reply at 2-3, 9.  Petitioner further complains that CMS did not address that change in policy.  P. Reply at 2-3, 9.  Petitioner’s complaints about state policy, assuming the complaints to be accurate, have no bearing upon this decision.  My review focuses on the requirements of the Act and regulations and whether Petitioner satisfied those requirements; changes in state laws, regulations, or regulatory policies have limited or no bearing except to the extent they set a time period for the initial report.  But, Petitioner should recognize, even a resident complaint of a lost sock might be a reportable allegation of abuse or misappropriation of resident property if the sock was taken or hidden to cause mental distress or anguish for the resident.  42 C.F.R. § 488.301 (abuse includes willful intimidation or punishment that may cause mental anguish).

Petitioner’s complaint that CMS revised the SOD to remove another incident involving another resident as an example of Petitioner’s alleged noncompliance with abuse reporting requirements has no bearing on my decision.  P. Br. at 14 n.14; P. Reply at 10 n.8.  I have concluded that the example of Resident 32 is sufficient to substantiate that Petitioner violated 42 C.F.R. § 483.13(c)(2) and (3), regardless of whether Petitioner’s treatment of other residents also would constitute noncompliance with the regulations.  CMS has discretion whether and when to cite a facility for noncompliance under the regulations.

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.13(c)(2) and (3) and the violations posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

20.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.13(c) (F226).

21.  The violation of 42 C.F.R. § 483.13(c) posed a risk for more than minimal harm and amounted to noncompliance.

22.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

a.  Facts

The facts found under Conclusions of Law 16 through 19 are applicable to Conclusions of Law 20 through 22.

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b.  Analysis

Section 1819(c)(1)(A)(ii) of the Act requires that a SNF protect its residents and promote their “right to be free from physical or mental abuse, corporal punishment, involuntary seclusion, and any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.”  The Secretary has provided by regulation that a “resident has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion.”  42 C.F.R. § 483.13(b).  The regulations require that a facility develop and implement written policies and procedures prohibiting mistreatment, neglect, and abuse of residents and the misappropriation of residents’ property.  42 C.F.R. § 483.13(c).

Based on the facts concerning Resident 32, the surveyors also alleged in the SOD that Petitioner violated 42 C.F.R. § 483.13(c) because Petitioner failed to implement its written policies and procedures prohibiting abuse, neglect, and mistreatment of residents and the misappropriation of resident property.  The violation is cited under Tag F226 and is alleged to have posed immediate jeopardy.  CMS Ex. 64 at 33-38.  The record shows that Petitioner had the required written policy and procedures, and the surveyors did not cite Petitioner for not having such a policy and procedures.  CMS Ex. 64 at 33-59; CMS Ex. 25 at 5-8; P. Ex. 19.  Rather, the surveyors cited Petitioner for failure to implement its policy and procedures.  CMS Ex. 64 at 33.

In examining whether a facility has implemented policies and procedures prohibiting abuse, neglect, mistreatment, and misappropriation, the Board has held that the issue under 42 C.F.R. § 483.13(c) is “whether the circumstances presented, viewed as a whole, demonstrate a systemic problem in implementing policies and procedures” to prevent abuse.  Columbus Nursing & Rehab. Ctr., DAB No. 2247 at 27 (2009) (citing Liberty Nursing & Rehab Ctr.–Johnston, DAB No. 2031 at 14 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr.–Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007)).

I conclude that the facts I have found related to the example of Resident 32 clearly show that Petitioner had a systemic failure in implementing the policies and procedures required by 42 C.F.R. § 483.13(c).  Resident 32 had two bruises on her left arm and wrist.  Initially the bruises were injuries of unknown cause discovered on May 24, 2014.  CNA Tucker alleges she immediately reported on May 24, 2014 to LPN Fugate, who denies receiving the report.  The evidence shows that no immediate report was made to Administrator O’Conner on May 24, 2014, and no report was made to the state until May 27 or 28, 2014.  Further, no investigation was initiated on May 24, 2014, and no action was taken to protect Resident 32 until the morning of May 25, 2014.  The facts show that while Petitioner had the required abuse and neglect policy, it was not implemented in the case of Resident 32.  Resident 32 suffered actual harm, which is more than minimal harm.  I conclude CMS has made a prima facie showing of violation of 42 C.F.R. § 483.13(c) under Tag F226.

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Petitioner’s arguments that I discussed in the previous section concerning its noncompliance with Tag F225 are the same arguments Petitioner uses to attack the allegations of its noncompliance with Tag F226.  In the interest of judicial economy, I do not repeat the discussion under this deficiency. 

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.13(c) and the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

23.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75 (F490).

24.  The violation of 42 C.F.R. § 483.75 posed a risk for more than minimal harm and amounted to noncompliance.

25.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

a.  Facts

The facts found under Conclusions of Law 16 through 19 are applicable to Conclusions of Law 23 through 25.

b.  Analysis

The regulation requires that Petitioner administer its facility 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.”  42 C.F.R. § 483.75.  The Board has held that a determination that a SNF failed to comply substantially with 42 C.F.R. § 483.75 may be derived from findings that the SNF was not in substantial compliance with other participation requirements.  Stone County Nursing & Rehab. Ctr., DAB No. 2276 at 15 (2009); Life Care Ctr. at Bardstown, DAB No. 2233 at 28 (2009); Britthaven, DAB No. 2018 at 22 (2006).

The surveyors alleged in the SOD that Petitioner was not administered “in a manner to ensure its resources, including policies related to abuse and neglect, were implemented to maintain the highest practicable physical, mental, and psychosocial well-being” for its residents.  CMS Ex. 64 at 59.  In essence, the surveyors alleged that Petitioner’s failure to (1) report immediately allegations of abuse to the state and (2) implement its policies and procedures to prevent abuse was attributable in large part to a failure by Petitioner’s administration.  CMS Ex. 64 at 59-64.

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Based on my findings of fact related to the example of Resident 32, I conclude that CMS made a prima facie showing of noncompliance under Tag F490, and Petitioner has failed to rebut the CMS prima facie case or establish substantial compliance or an affirmative defense by a preponderance of the evidence.  The preponderance of the evidence shows that Petitioner was not in substantial compliance with Tags F225 and F226 as they relate to Resident 32 because it failed to follow its own policies and federal guidelines requiring it report immediately all allegations of abuse to the administrator and the state, and Petitioner failed to protect the resident.  Petitioner’s noncompliance with Tag F490 derives from its noncompliance with Tags F225 and F226.  In other words, by failing to implement Petitioner’s anti-abuse policies and procedures, Petitioner’s administration also failed to administer Petitioner in “a manner that enable[d] it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.”  42 C.F.R. § 483.75.

Petitioner argues that the evidence shows that its “managers duly responded to and investigated reports that potentially could have implicated wrongdoing, and in each case reached immediate reasoned decisions that no regulatory violations had occurred.”  P. Br. at 29-30; P. Reply at 25.  Petitioner asserts that the surveyors’ disagreement with those reasoned decisions does not transform Petitioner’s response to Resident 32’s complaint into regulatory noncompliance.  P. Br. at 29-30; P. Reply at 25.  Petitioner overlooks that the regulatory requirement is to report all allegations to the administrator and the state immediately, and that did not occur in this case.  The administrator or DON is not permitted to decide that an allegation is unfounded or not substantiated and not report on that basis.

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75 and the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

26.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75(o) (F520).

27.  The violation of 42 C.F.R. § 483.75(o) posed a risk for more than minimal harm and amounted to noncompliance.

28.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.

a.  Facts

The facts found under Conclusions of Law 16 through 19 are applicable to Conclusions of Law 26 through 28.

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b.  Analysis

The requirements of 42 C.F.R. § 483.75(o) have been discussed in the analysis section following Conclusions of Law 12 through 14.  The surveyors allege in the SOD that Petitioner failed to maintain an effective QA committee because the QA committee failed to recognize that its abuse and neglect policy was not effectively implemented.  More specifically, the surveyors alleged that Petitioner failed to ensure its QA committee “developed and implemented appropriate plans of action related to abuse prevention” and that this failure had the potential to cause more than minimal harm to Petitioner’s residents.  CMS Ex. 64 at 84-88.

Based on the facts I have found related to Resident 8, I concluded that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75(o).  Many members of Petitioner’s QA committee, including the DON and Administrator (CMS Ex. 50), attended the daily “stand-up” meeting where resident and operational issues were discussed.  But, the QA committee failed to identify the need for correction and to develop and implement an effective plan of action to correct the failure to immediately report to the administrator and state officials alleged neglect, abuse, injuries of unknown cause, and misappropriation of resident property; and to protect a resident during the investigation of such allegation; as required both by Petitioner’s policy (P. Ex. 19) and 42 C.F.R. § 483.13(c).  An important regulatory purpose for the QA committee is to develop and implement appropriate plans of action to correct identified quality deficiencies.  42 C.F.R. § 483.75(o)(2).

In the example of Resident 32, there was delayed reporting of the bruising of the resident’s arm or wrist, which were injuries of unknown cause when first reported on May 24, 2014.  When the bruising was reported to two LPNs during the morning of May 25, 2014, both DON Stewart and Administrator O’Conner were notified, and it is more likely than not that the matter was discussed during the daily stand-up meeting.  Petitioner has presented no evidence of any discussion or action by the QA committee to oversee compliance with Petitioner’s abuse and neglect policy.  When DON Stewart decided that she found the allegation unsubstantiated, there appears to have been no alarm raised by the Administrator O’Conner or the QA committee about compliance with Petitioner’s policy or 42 C.F.R. § 483.13(c).  The evidence supports an inference that Petitioner’s QA committee was not operating and fulfilling the requirements of 42 C.F.R. § 483.75(o)(2) based on these facts.  The failure of Petitioner’s QA committee posed a risk for more than minimal harm to Resident 32 and all Petitioner’s residents.  I therefore conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75(o) and the violation posed a risk for more than minimal harm.  Petitioner has failed to rebut the CMS prima facie case or establish substantial compliance or an affirmative defense by a preponderance of the evidence.

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Petitioner repeats the same argument it made regarding Tag F490 to argue that it did not violate Tag F520 in the example of Resident 32.  P. Br. at 29-30; P. Reply at 25.  I reject those arguments for the reasons already discussed.

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75(o) and the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

29.  The declaration of immediate jeopardy related to the noncompliance based on violations of 42 C.F.R. §§ 483.13(c)(2) and (3); 483.13(c); 483.75; and 483.75(o) was not clearly erroneous.

The surveyors concluded that the violations of 42 C.F.R. §§ 483.13(c)(2)-(4); 483.13(c); 483.75; and 483.75(o) posed immediate jeopardy that began May 24, 2014, and was abated on May 31, 2014.  P. Ex. 1 at 1.  CMS proposes to impose a CMP in the higher range of CMPs that may be imposed for immediate jeopardy from May 24, 2014 through May 30, 2014 (Jt. Stip. ¶ 10), and that is the period of immediate jeopardy at issue before me related to the June 4, 2014 survey.

Applying the clearly erroneous standard, described above in my discussion following Conclusion of Law 15, to the record before me related to the noncompliance I have found, I have no definite and firm conviction that an error has been committed either by the declaration of immediate jeopardy or the period of immediate jeopardy from May 24, 2014 through May 30, 2014.  Petitioner’s staff clearly failed to handle the allegation of abuse made by Resident 32 in accordance with its abuse and neglect policy.  The violation posed a risk for more than minimal harm for not only Resident 32, but all of Petitioner’s residents.  Petitioner has failed to show that the risk for harm did not amount to a risk for serious injury or death to Resident 32 or other residents.  On the record before me, I have no definite and firm conviction that the declaration of immediate jeopardy was in error.

Petitioner’s arguments to the contrary are unpersuasive.  Petitioner asserts non-specifically that “none of the cited facts plausibly cause the likelihood of death or serious harm.”  P. Br. at 30.  In the example of Resident 32, Petitioner also argues that “it is hard to articulate how any noncompliance could have caused the ‘likelihood of death or serious harm,’” pointing to some 200 reports to the state agency it made in the aftermath of the June 4, 2014 survey.  P. Reply at 26; Tr. at 653, 683-84.  Petitioner’s actions to regain compliance hardly demonstrate that its earlier noncompliance did not pose immediate jeopardy.  Petitioner’s other arguments are similarly unpersuasive, as they do not address, much less carry, Petitioner’s heavy burden to give me a definite and firm conviction that an error was committed in the declaration of immediate jeopardy.  Petitioner appears to ignore completely the risk to all of its residents posed by the practice of top members of Petitioner’s staff to treat allegations of abuse as non-

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reportable grievances or mere complaints.  I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the noncompliance under 42 C.F.R. §§ 483.13(c)(2) and (3) (Tag F225); 483.25(c) (Tag F226); 483.75 (Tag F490); and 483.75(o) (Tag F520) during the period of May 24, 2014 through May 30, 2014, was clearly erroneous.

30.  A $4,150 per day CMP effective March 8, 2014 through March 30, 2014; a $150 per day CMP effective March 31, 2014 through May 23, 2014; a $4,050 per day CMP effective May 24, 2014 through May 30, 2014; a $250 per day CMP effective May 31, 2014 through June 11, 2014; and a DPNA for the period May 13, 2014 through June 11, 2014, are reasonable enforcement remedies.

31.  Petitioner was ineligible to be approved to conduct a NATCEP for two years by operation of law.

I have concluded that Petitioner was not in substantial compliance with the participation requirements established by 42 C.F.R. §§ 483.13(c)(2)-(4) (Tag F225); 483.13(c) (Tag F226); 483.25(m)(2) (Tag F333); 483.60(c) (Tag F428); 483.75 (Tag F490); and 483.75(o) (Tag F520).  I have also concluded that Petitioner has not shown clearly erroneous the declarations of immediate jeopardy related to the noncompliance from March 8, 2014 through March 30, 2014, and from May 24, 2014 through May 30, 2014.

Petitioner did not request review of the following deficiency citations from the survey that ended on April 3, 2014 (Jt. Stip. ¶ 8; P. Br. at 3 n.1); the deficiency citations are administratively final; and the deficiencies are a basis for the imposition of enforcement remedies, including a CMP in the lower range authorized for non-jeopardy deficiencies:  42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282) (s/s E), 483.25(k) (Tag F328) (s/s E), 483.35(i) (Tag F371) (s/s E), and 483.65 (Tag F441) (s/s D) (unchallenged deficiencies).

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, including a DPNA or a CMP.  CMS may impose a DPNA when a facility is not in substantial compliance, and payment does not resume until the facility returns to substantial compliance.  42 C.F.R. § 488.417(a), (c), (d).  CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, 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 CMPs, $50 per day to $3,000 per day, is

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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).

CMS imposed the following remedies based on the surveys conducted during the survey cycle:

March 8 through 30, 2014 – $4,150 per day CMP 
March 31 through May 23, 2014 – $150 per day CMP
May 24 through May 30, 2014 – $4,050 per day CMP
May 31 through June 11, 2014 – $250 per day CMP
June 12 through June 24, 2014 – $5,500 per day CMP
June 25 through July 12, 2014 – $300 per day CMP
May 13 through July 12, 2014 – DPNA

Petitioner waived its right to review of deficiencies cited by the survey that ended on June 25, 2014, and related enforcement remedies.  Jt. Stip. ¶ 11; September RFH at 1; P. Br. at 3 n.1; 4 n.3.  Accordingly, the $5,500 per day CMP from June 12 through 24, 2014, the $300 per day CMP from June 25 through July 12, 2014; and the DPNA from June 25, 2014 through July 12, 2014, and bases for imposition of those enforcement remedies are not at issue before me.  I conclude Petitioner waived review as to CMS’s determination that Petitioner returned to substantial compliance on July 13, 2014.

I conclude that a DPNA from May 13, 2014 through June 11, 2014, is appropriate and reasonable in this case based on my previous conclusion that Petitioner was not in substantial compliance for that entire period.  Petitioner agreed at hearing that the DPNA could be sustained on the non-jeopardy tags alone.  Tr. 50-52.  If Petitioner established that it returned to substantial compliance any time prior to May 13, 2014, a DPNA would not be reasonable.  Petitioner failed to make the required showing and, in fact, has effectively conceded continuing noncompliance from March 8, 2014 through July 12, 2014, based on the waiver of review as to the non-jeopardy deficiencies.

Petitioner agreed at hearing that the non-jeopardy deficiency citations for which Petitioner did not request review are sufficient to support a CMP in the lower range of authorized CMPs and a DPNA for the entire period from March 8 through June 11, 2014.  Tr. 53-54.  I conclude, out of an abundance of caution, based upon my discussion with counsel at hearing, the June and September requests for hearing, and the briefs of Petitioner that the reasonableness of the CMP, in the following amounts, is at issue before me:

March 8 through 30, 2014 – $4,150 per day CMP 
March 31 through May 23, 2014 – $150 per day CMP
May 24 through May 30, 2014 – $4,050 per day CMP

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May 31 through June 11, 2014 – $250 per day CMP

Tr. 52-55.

I conclude that a CMP in the higher range of CMPs authorized for immediate jeopardy is appropriate in this case for the two periods of immediate jeopardy.  I conclude that a CMP of $4,150 per day effective March 8, 2014 through March 30, 2014, and a CMP of $4,050 per day effective May 24, 2014 through May 30, 2014, the periods of immediate jeopardy, are not unreasonable.  I also conclude that a CMP of $150 per day for March 31 through May 23, 2014, is not unreasonable based on the unchallenged deficiency citations from the April 3, 2013 survey.

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are:  (1) I may not set the CMP at zero or reduce it to zero, (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP, and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.  The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.  My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  Emerald Oaks,DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

Petitioner has a history of deficiency citations related to abuse investigation and reporting under Tag F225 identified during a survey completed in February 2012.  CMS Ex. 60 at 1.  There is no evidence that an enforcement remedy was imposed based on the past

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citation of Tag F225 or that there was an ALJ hearing related to that survey.  Petitioner was also cited for immediate jeopardy level deficiencies for two of the four same tags in both the April 3, 2014 and June 4, 2014 surveys (Tags F225 and F520).  Petitioner has presented no evidence in this case that it is unable to pay the CMP.  The noncompliance posed immediate jeopardy and was serious as it placed Resident 8 at grave risk of a serious allergic reaction, and it placed all of Petitioner’s residents, particularly Resident 32, at risk for harm from unreported abuse by Petitioner’s staff.  Petitioner was culpable particularly since the immediate jeopardy noncompliance was in part the result of actions (or inaction) by senior members of Petitioner’s staff, including the medical director, administrator, and DON.  Particularly troubling are the serious breakdown in Petitioner’s system for monitoring medication allergies for a resident who Petitioner recognized was at an increased risk of suffering from allergic reactions as indicated by her care plan and the failure by the administrator and DON to report a clear allegation of abuse by a resident because they found the allegation not credible.  The CMPs imposed by CMS, which are at the low end of the range authorized for immediate jeopardy noncompliance, are fairly modest given Petitioner’s serious noncompliance.

I conclude that the CMPs of $4,150 per day proposed by CMS for the days of immediate jeopardy from March 8, 2014 through March 30, 2014, and $4,050 per day proposed by CMS for the days of immediate jeopardy from May 24, 2014 through May 30, 2014, are reasonable.

Pursuant to 42 C.F.R. § 483.151(b)(2) and (f)(1), Petitioner was rendered ineligible to conduct a NATCEP for a period of two years based on the CMP, the DPNA, and the extended survey triggered by findings of substandard quality of care.

32.  Other defenses and issues raised by Petitioner are without merit or are not within my authority to decide.

In its June 11, 2014 and September 12, 2014 requests for hearing, Petitioner objected to the Board practice, as reflected in decisions of the Board, of allocating the burden of proving substantial compliance to Petitioner, arguing that it amounts to a violation of 5 U.S.C. § 556(d).  Petitioner argues that allocating the burden of persuasion to Petitioner allows the Board to minimize or disregard Petitioner’s evidence of compliance and deprives Petitioner of its property without due process and allows CMS to impose enforcement remedies without requiring CMS to show that it considered the regulatory criteria for imposing remedies required by 42 C.F.R. §§ 488.404 and 488.438(f).  June RFH at 6.

a.  Allocation of the Burden of Persuasion

Petitioner argues that the allocation of the burden of persuasion in this case, according to the rationale of the Board in the prior decisions cited above, deprives Petitioner of its

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property without due process of law and violates the Administrative Procedures Act, 5 U.S.C. § 551 et. seq., specifically 5 U.S.C. § 556(d).  P. Br. at 30 n.28; September RFH at 7.  Pursuant to the scheme for the allocation of burdens adopted by the Board in its prior cases, CMS bears the burden to come forward with the evidence and to establish a prima facie showing of the alleged regulatory violations in this case by an unspecified quantum of evidence.  If CMS makes its prima facie showing, Petitioner has the burden of coming forward with any evidence in rebuttal and the burden of showing by a preponderance of the evidence that it was in substantial compliance with program participation requirements.  Petitioner bears the burden to establish by a preponderance of the evidence any affirmative defense.  The allocation of burdens suggested by the Board is not inconsistent with due process or the requirements of 5 U.S.C. § 556(d), as CMS is required to come forward with the evidence that establishes its prima facie case.

Board decisions are not binding precedent and only retrospective in application.  I re-examine in each case the rationale of the Board for its interpretive rule allocating the burden of persuasion to determine whether the Board decision is persuasive precedent.  I see no reason to upset the allocation as described by the Board given that I am satisfied that the CMS prima facie case is supported by a preponderance of the evidence in this case and Petitioner has not met its burden to rebut the CMS case by a preponderance of the evidence or to establish an affirmative defense.

b.  Regulatory Factors Related to Enforcement Remedies Are Reviewed De Novo

Petitioner also argues that the Medicare Act is violated and Petitioner is deprived of due process if CMS is not required to submit evidence to prove it considered the regulatory criteria established by 42 C.F.R. §§ 488.404 and 488.438(f) in determining enforcement remedies.  September RFH at 7.  I reviewed the evidence related to the regulatory factors de novo and perceive no prejudice to Petitioner because I did not require CMS to submit evidence related to its consideration of the regulatory factors.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from March 8, 2014 through June 11, 2014.  There is a basis for the imposition of the following enforcement remedies, which are reasonable:  a $4,150 per day CMP effective March 8, 2014 through March 30, 2014; a $150 per day CMP effective March 31, 2014 through May 23, 2014; a $4,050 per day

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CMP effective May 24, 2014 through May 30, 2014; a $250 per day CMP effective May 31, 2014 through June 11, 2014; and a DPNA for the period May 13, 2014 through June 11, 2014.

• 1. This is a “Tag” designation as used in CMS Pub.100-07, State Operations Manual (SOM), Appendix PP – Guidance to Surveyors for Long Term Care Facilities (http://www.cms.hhs.gov/Manuals/IOM/list.asp). The “Tag” refers to the specific regulatory provision allegedly violated and CMS policy guidance to surveyors. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations as interpreted in the SOM clearly do have such force and effect. Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993). Thus, while the Secretary of Health and Human Services (Secretary) may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
• 2. Citations are to the 2013 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.
• 3. The Statement of Deficiencies (SOD) for the survey that ended April 3, 2014, cites to 42 C.F.R. § 483.13(c)(1)(ii)-(iii) in addition to subsections (c)(2)-(4). CMS Ex. 2 at 3. However, the facts alleged do not reflect an alleged violation or 42 C.F.R. § 423.13(c)(1)(ii)-(iii), and I conclude that the citation to those subsections is a scrivener’s error.
• 4. Scope and severity levels are used by CMS and a state when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, Chap. 7, § 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
• 5. The SOD for the survey that ended June 4, 2014, cites the deficiency under 42 C.F.R. § 483.13(c)(1)(ii)-(iii) in addition to subsections (c)(2)-(4). CMS Exs. 64 at 2; 65 at 2. However, the facts alleged do not reflect an alleged violation of 42 C.F.R. § 423.13(c)(1)(ii)-(iii), and I conclude that the citation to those subsections is a scrivener’s error.
• 6. Although I admitted CMS Ex. 41 into evidence, I indicated that I would not rely on it in my decision because it was not the final and complete SOD for the June 4, 2014 survey. I rely instead on CMS Exs. 64 and 65, which are a copy of the final and complete SOD and a copy of the SOD containing Petitioner’s plan of correction, respectively. Tr. at 70-71
• 7. Participation of a NF in Medicaid is governed by section 1919 of the Act. Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.
• 8. “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596 (8th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to other evidence. Id. at 1625.
• 9. There is no dispute that Macrobid®, the antibiotic ordered, and Macrodantin® contain the same active ingredient antibiotic nitrofurantoin. CMS Ex. 21 at 42, 106; P. Ex. 7 at 1; Tr. at 451, 493-94, 581.
• 10. Petitioner’s claim that “Mr. Thacker testified with some certainty that the documents Pikeville Medical Center provided with the referral and admission packets for Resident #8 included a history and physical report that did not include any information about an allergy to Macrodantin[®]” is not supported by a preponderance of the evidence. P. Br. at 7; P. Reply at 5. Furthermore, Mr. Thacker’s testimony was limited solely to the content of the referral packet for Resident 8, and he never asserted that he saw the resident’s admission packet.
• 11. Because Resident 8’s Medication Record indicates that Petitioner’s staff administered only seven doses of Macrobid®, I infer that the nurse investigator simply miscounted the number of doses administered when writing the investigation report.
• 12. The date the face sheet was updated is not entirely clear because the update is not dated and ADON Cook, who made the update, was uncertain that March 27, 2014, was the date she actually updated it. Tr. at 576-77, 587-89. At a minimum, it is clear that the update did not occur until after Petitioner’s reaction to Macrobid®.
• 13. Petitioner’s argument that the citation to 42 C.F.R. § 483.13(c)(2), (3), and (4) is misplaced because in this case there was no allegation of neglect triggering its reporting obligation is without merit. P. Br. at 22-23; P. Reply at 18. The reasonable suspicion of neglect triggers the regulation whether or not it is subsequently determined neglect occurred.
• 14. Petitioner observes, without realizing the irony, that we “know . . . that at least some of Pikeville Medical Center’s physicians created inconsistent lists of Resident #8’s medication allergies, which suggests that the hospital’s electronic medical record system and documentation practices were not as tight as they could be.” P. Reply at 8. Petitioner apparently does not recognize that its criticism of Pikeville Medical Center applies with greater force to Petitioner given its completely inconsistent listing of Resident 8’s medication allergies throughout her records, even after the care plan team created a care plan to address her numerous potential drug allergies.
• 15. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. State of Indiana by the Indiana Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993). Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
• 16. Merriam-Webster, www.m-w.com (last updated June 3, 2018).
• 17. Petitioner did not list Macrobid® or nitrofurantoin when updating Resident 8’s records. Listing alternative proprietary names and generic names may be unnecessary depending upon the level of knowledge of nursing staff. However, out of an abundance of caution, it would seem safest to list the various names of a drug that is reported to cause a possible allergic reaction. In this case, three different names are used throughout the record all referring essentially to the same antibiotic.
• 18. Although the appellate panels of the Board generally have discussed facilities’ liability for the actions of their employees, their logic applies equally to contracted services. A SNF cannot avoid its regulatory responsibilities by providing care through contractors rather than employees. If a facility elects to fulfill its care obligations through contractors, it cannot reasonably claim the contractors’ misconduct or professional errors are irrelevant when evaluating the facility’s compliance.
• 19. Decisions often cited include: Lakeport Skilled Nursing Ctr., DAB No. 2435 at 7 (2012); Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Britthaven of Havelock, DAB No. 2078 (2007); Daughters of Miriam Ctr., DAB No. 2067; Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726 at 39.
• 20. The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard. However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.
• 21. Appendix Q of the SOM also fails to provide surveyors a working definition of the term “serious” that they can use to determine whether harm, injury, or impairment is serious when deciding whether or not to declare immediate jeopardy. The Act does not define the phrase “immediately jeopardize” and does not introduce the concept of serious harm, injury, or impairment as the basis for finding immediate jeopardy. Thus, one is not in error concluding that absent a definition of the term “serious” in the Act, the regulations, the SOM, or decisions of the Board, it is essentially up to individual surveyors, and whatever unpublished guidance they receive from their superiors or CMS officials, to exercise their individual discretion and judgment to decide that there was immediate jeopardy, which subjects a facility to the maximum imposable CMPs.
• 22. This statement is part of the five-day follow-up report required by the state agency. CMS Ex. 47 at 9-11.
• 23. Although it does not affect my decision in this case, the reader may be interested to know that CNA Tucker was subsequently involved in another incident involving alleged abusive language on about June 17, 2014, and she was ultimately terminated effective that date. P. Ex. 30.
• 24. In further support, Petitioner attaches to its post-hearing brief and quotes from a decision by a state ALJ involving the Kentucky state law abuse reporting requirement. Appendix to P. Br.; P. Br. at 16-17. As Petitioner acknowledges, this decision is not binding on me, and after reviewing it, I do not find it to be persuasive.
• 25. Worth noting, however, is that the regulations in 42 C.F.R. part 483 were recently changed to include a definition of abuse that is consistent with the definition found in the 2013 version of 42 C.F.R. § 488.301. 42 C.F.R. § 483.5 (2017). That updated definition is identical to the definition of abuse found in the current version of 42 C.F.R. § 488.301.