The Heights of Tomball, ALJ Ruling 2021-6 (HHS CRD July 9, 2021)

RULING GRANTING PARTIAL SUMMARY JUDGMENT TO THE CENTERS FOR MEDICARE & MEDICAID SERVICES

Petitioner, The Heights of Tomball, appeals the Centers for Medicare & Medicaid Services’ (CMS) determinations that it was not in substantial compliance with federal participation requirements arising from surveys completed by the Texas Department of Aging and Disability Services (state agency) on October 27, 2016, and January 4, 2017.  Departmental Appeals Board (DAB or Board) Electronic Filing System (E-File) Docket Entry No. 1 (Petitioner’s Request for Hearing (P. RFH) at 1).  Petitioner also challenges CMS’ imposition of enforcement remedies, including denial of payment for new admissions (DPNA) for 63 days, a $1,203 per-day civil money penalty (CMP) totaling $44,511, and a $303 per-day CMP totaling $13,635.  Id. at 2-3; CMS Exhibit (Ex.) 1 at 19-21. 

Both parties moved for summary judgment and opposed the other parties’ motion for summary judgment.  DAB E-File Docket Entry Nos. 8, 8a, 13, 15, 17.  For the reasons explained below, I conclude that there is no genuine dispute as to any material fact with respect to the October 2016 survey cycle, and CMS is entitled to partial summary judgment as a matter of law.  Viewing the facts in the light most favorable to the non-

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moving party, I conclude that Petitioner was not in substantial compliance with Medicare participation requirements based on the surveys and complaint investigation completed on October 27, 2016.  However, I conclude that material facts are in dispute with respect to the complaint investigation completed on January 4, 2017.  Accordingly, I grant CMS’ summary judgment motion, in part, and deny Petitioner’s summary judgment motion in its entirety. 

A hearing is required to resolve the outstanding issues of whether Petitioner was in substantial compliance regarding the January 4, 2017 complaint investigation and whether the enforcement remedies imposed by CMS are reasonable.  A Notice of Hearing is forthcoming.

I.   Background and Procedural History

A. Regulatory Framework

The Social Security Act (Act) establishes requirements for a skilled nursing facility (SNF) to participate in the Medicare program and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing those statutory provisions.  42 U.S.C. §§ 1395i-3, 1395hh.  To participate in the Medicare program, a SNF must maintain “substantial compliance” with the requirements at 42 C.F.R. Part 483, subpart B.  42 U.S.C. § 1395i-3(b)-(d); 42 C.F.R. § 488.301.  To be in substantial compliance, a SNF’s “deficiency,” defined as a failure to meet a participation requirement established by the Act or the Secretary’s regulations, may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with Medicare participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10(a), 488.20.  State agencies also investigate complaints that SNFs have violated the Medicare participation requirements.  42 U.S.C. § 1395i–3(g)(4); 42 C.F.R. § 488.332(a).1  CMS may impose enforcement remedies against SNFs that are not in substantial compliance with one or more participation requirements.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. §§ 488.400, 488.402(b)-(c), 488.406.  The purpose of imposing remedies is to ensure prompt compliance with program requirements.  42 CFR § 488.402(a).  When selecting enforcement remedies, CMS considers the “seriousness” of the SNF’s deficiencies (i.e., the level of noncompliance). 

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42 C.F.R. § 488.404(a).  The seriousness of the deficiency is based on its severity (i.e., whether the noncompliance has created a “potential for more than minimal harm,” resulted in “actual harm,” or placed residents in “immediate jeopardy”) and scope (i.e., whether the noncompliance is “isolated,” constitutes a “pattern,” or is “widespread).  42 C.F.R. § 488.404(b).  “Immediate jeopardy” exists when the facility’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. 

A deficiency’s combined scope and severity level is designated by letters “A” through “L,” which have been placed in a matrix published in the State Operations Manual (SOM).  SOM, CMS Publ’n 100-07, ch. 7, § 7400.5.1 (Rev. 63, effective Sept. 10, 2010) (applicable table at the time of the surveys at issue) (pursuant to Rev. 185, issued November 16, 2018, the matrix currently appears at § 7400.3.1 of the SOM, but the substance is largely unchanged).  Relevant here, a scope and severity level of “E” represents a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  A “pattern” exists when “more than a very limited number of residents or employees are affected, and/or the situation has occurred in more than a limited number of locations but the locations are not dispersed throughout the facility.”  SOM, ch. 7, § 7410.2.1.  A scope and severity level of “F” exists when the deficiency is widespread and presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.2  SOM, ch. 7, § 7400.5.1.  A deficiency is considered “widespread” when “the problems causing the deficiency are pervasive (affect many locations) throughout the facility and/or represent a systemic failure that affected, or has the potential to affect, a large portion or all of the residents or employees.”  SOM, ch. 7, § 7410.2.1.  A scope and severity level of “G” exists when the deficiency is isolated and constitutes actual harm that is not immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  A deficiency is “isolated” when “one or a very limited number of residents or employees is/are affected and/or a very limited area or number of locations within the facility are affected.”  SOM, ch. 7, § 7410.2.1.

The Act authorizes the Secretary to impose enforcement remedies against a SNF that is not in substantial compliance with program participation requirements.  Act § 1819(h)(2); 42 C.F.R. § 488.402.  The regulations specify the enforcement remedies that CMS or the state agency may impose for noncompliance.   42 C.F.R. § 488.406.  In addition to

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termination and other enforcement remedies, CMS (or the state agency) may impose a DPNA, a per-day CMP for the number of days a SNF is not in substantial compliance, or a per-instance CMP for each instance of the SNF’s noncompliance, regardless of whether or not the deficiencies constitute immediate jeopardy.  42 C.F.R. § 488.406; 488.430(a).   At the time of the surveys at issue in this case, CMS was authorized to impose a CMP  ranging from $103 to $6,188 per day for less serious noncompliance, or $6,291 to $20,628 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  42 C.F.R. § 488.438(a)(1).3  The per-day CMP may accrue until the facility achieves substantial compliance or its provider agreement is terminated.  42 C.F.R. § 488.454(a).  Also, as relevant here, the authorized range for a per-instance CMP is $2,063 to $20,628, regardless of whether the deficiencies constitute immediate jeopardy.4  42 C.F.R. § 488.438(a)(2).  The CMP is a fixed amount imposed for the specific instance of noncompliance.  42 C.F.R. § 488.454(d).

A SNF may request a de novo hearing before an ALJ to challenge a noncompliance finding that led to the imposition of an enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395cc(h)(1); 42 C.F.R. §§ 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13); see also CarePlex of Silver Spring, DAB No. 1683 (1999) (holding that ALJs hold de novo hearings based on issues permitted under the regulations and ALJ review is not a quasi-appellate review); Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 843 (6th Cir. 2010) (stating that the Board “reviewed the finding under the de novo standard that the ALJ would have applied”); Columbus Park Nursing & Rehab. Ctr. v. Sebelius, 940 F. Supp. 2d 805, 817-18 (N.D. Ill. 2013) (finding that the court lacked jurisdiction where the ALJ and Board also lacked jurisdiction because CMS had not imposed an enforcement remedy).  The scope of ALJ review includes the finding of noncompliance leading to an enforcement remedy and whether the amount of the CMP is reasonable.  42 C.F.R. §§ 488.408(g)(1), 488.438(e)-(f).  However, CMS’ choice of remedies and the factors CMS considered when choosing remedies are not subject to review.  42 C.F.R. §§ 488.408(g)(2), 488.438(e)(2), 498.3(b)(13).  A determination with respect to the level of noncompliance may be appealed only if a successful challenge on this issue would affect the range of CMP amounts that CMS could collect or if CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s Nurse Aide Training and Competency Evaluation Program (NATCEP).  42 C.F.R. §§ 498.3(b)(14), (d)(10)(i).  On review, CMS’ determination as to the level of noncompliance “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2).

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As to the burdens of proof, CMS has the burden to produce evidence sufficient to make a prima facie case that Petitioner is not in substantial compliance with Medicare participation requirements and has a basis to impose an enforcement remedy.  See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  If CMS makes this prima facie showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied with the participation requirements.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense or rebuttal evidence.  To prevail, Petitioner must show by a preponderance of the evidence on the record as a whole that it was in substantial compliance with Medicare participation requirements.  Id. at 7-8; see also Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

B.   Petitioner’s Request for Hearing and Procedural History

Petitioner is a skilled nursing facility located in Tomball, Texas, that participates in Medicare.  On October 27, 2016, surveyors from the state agency completed a complaint investigation and an annual survey, consisting of a standard health survey, standard life safety code survey (LSC), and licensing inspection, at Petitioner’s facility.  CMS Ex. 11 at 1; P. Ex. 1 at 1.  On November 10, 2016, the state agency notified Petitioner that it did not meet state licensure requirements5 and was not in substantial compliance with Medicare participation requirements.  P. Ex. 1 at 1.  Specifically, with regard to Medicare participation requirements, the state agency found the following deficiencies: 

Long-Term Care (LTC) requirements (42 C.F.R. Part 483)

• 42 C.F.R. § 483.10(b)(11) – Resident Rights:  Notification of changes. (Tag F-1576 at scope and severity level E)

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• 42 C.F.R. § 483.25(c) – Quality of care:  Pressure sores. (Tag F-314 at scope and severity level E)
• 42 C.F.R. § 483.25(d) – Quality of care:  Urinary incontinence. (Tag F-3157 at scope and severity level E)
• 42 C.F.R. § 483.60(b), (d), (e) – Pharmacy services:  Service consultation; Labeling of drugs and biologicals; and Storage of drugs and biologicals. (Tag F-431 at scope and severity level F)
• 42 C.F.R. § 483.75(l)(1) – Administration:  Clinical records. (Tag F-514 at scope and severity level F)

LSC standards (42 C.F.R. § 483.70(a))

• 42 C.F.R. § 483.70(a) – Physical environment:  Life safety from fire. (Tag K-25,8 smoke barrier construction, at scope and severity level F)
• 42 C.F.R. § 483.70(a) – Physical environment:  Life safety from fire.  (Tag K-69, cooking facilities, at scope and severity level E)
• 42 C.F.R. § 483.70(a) – Physical environment:  Life safety from fire. (Tag K-72, means of egress, at scope and severity level E)

CMS Exs. 11, 25-28.  Tags F-157, F-314, F-315, K-69, and K-72 were cited at scope and severity level E, which indicates a pattern of no actual harm with the potential for more than minimal harm that is not immediate jeopardy.  Tags F-431, F-514, and K-25 were cited at scope and severity level F, which indicates widespread deficiencies that constitute no actual harm with a potential for more than minimal harm that is not immediate jeopardy.  Based on the cited deficiencies, the state agency formally notified Petitioner that payment for new Medicare and Medicaid admissions would be denied, starting November 25, 2016, and continuing until Petitioner achieved substantial

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compliance or its provider agreement was terminated.  P. Ex. 1 at 2.  The state agency also recommended termination of Petitioner’s provider agreement if substantial compliance were not achieved by April 27, 2017.  Id. 

On November 16, 2016, CMS notified Petitioner that it concurred with the state agency’s findings that Petitioner’s facility was not in substantial compliance with Medicare requirements and imposed the remedies of DPNA and termination.  CMS Ex. 1 at 1-2.  The state agency conducted a revisit survey on December 2, 2016, and found that Petitioner corrected all LSC deficiencies cited at the October 2016 survey on November 11, 2016.  P. Ex. 2 at 2.  On January 12, 2017, the state agency conducted a second revisit survey and found that Petitioner also corrected all LTC deficiencies cited at the October 2016 survey on November 11, 2016.  Id. at 1. 

Between the two revisit surveys regarding the October 2016 surveys, the state agency completed a new complaint investigation concerning Resident #1 on January 4, 2017.9   CMS Ex. 2.  The state agency found that Petitioner was not in substantial compliance with Medicare participation requirements related to 42 C.F.R. § 483.24 (Quality of life); 42 C.F.R. § 483.25(k) (Quality of care:  Pain management); and 42 C.F.R. § 483.25(l) (Quality of care:  Dialysis).  The state agency cited Tag F-309 at scope and severity level G.  As a result of the January 4, 2017 complaint investigation, the state agency recommended continuation of the previous enforcement remedies, a $1,950 per-instance CMP, and termination if Petitioner were not in substantial compliance by April 27, 2017.10  P. Ex. 3 at 1-2; P. Ex. 7. 

On January 19, 2017, CMS notified Petitioner that it concurred with the state agency’s finding that it was not in compliance with federal participation requirements.  CMS Ex. 1 at 5-11.  In addition to continuation of the DPNA and proposed termination if Petitioner did not establish substantial compliance by April 27, 2017, CMS added a $1,950 per-instance CMP for the deficiency found at the January 2017 investigation.  CMS Ex. 1 at 5-6.  On January 23, 2017, CMS notified Petitioner of revised remedies.  CMS Ex. 1 at 12-18.  CMS rescinded the $1,950 per-instance CMP and imposed a $1,203 per-day CMP for 37 days, beginning November 6, 2016 through December 12, 2016, which

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totaled $44,511.  Id. at 12.  CMS also imposed a $303 per-day CMP, beginning December 13, 2016 until Petitioner achieved substantial compliance.  Id.  The previous remedies of the DPNA, beginning November 25, 2016, and proposed termination, on April 27, 2017, remained in effect until Petitioner achieved substantial compliance or termination.  Id. at 12-13.  

On February 28, 2017, CMS notified Petitioner that its facility achieved substantial compliance, effective January 27, 2017.  CMS Ex. 1 at 19-21.  CMS rescinded the proposed termination and ended the DPNA and $303 per-day CMP on January 26, 2017.  Thus, Petitioner’s final enforcement remedies included the following: 

• A DPNA for 63 days, beginning November 25, 2016 through January 26, 2017;
• A $1,203 per-day CMP for 37 days, beginning November 6, 2016 through December 12, 2016, which totaled $44,511; and
• A $303 per-day CMP for 45 days, beginning December 13, 2016 through January 26, 2017, which totaled $13,635.

CMS Ex. 1 at 19.

On March 24, 2017, Petitioner timely requested a hearing to appeal substantial noncompliance findings and imposition of the DPNA and CMPs.  P. RFH at 2-3.  The case was docketed and assigned to ALJ Carolyn Cozad Hughes.  On March 31, 2017, Judge Hughes issued an Acknowledgment and Initial Prehearing Order (prehearing order) establishing a prehearing exchange schedule for the parties.  DAB E-File Docket Entry Nos. 2, 2a-2b.  The prehearing order directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.  The prehearing order also set forth guidelines for the parties to file a motion for summary judgment.

On June 29, 2017, CMS filed an exchange, including a prehearing brief (CMS Br.), a proposed witness list, a proposed exhibit list, and 29 proposed exhibits (CMS Exs. 1-29).  DAB E-File Docket Entry Nos. 4, 4a-4j, 5, 5a-5i, 6, 6a-6h, and 7.  CMS offered the declaration of one witness, Captain (Ret.) Daniel J. McElroy, R.N., a CMS Nurse Consultant.  CMS Ex. 29.  On July 17, 2017, Petitioner filed its exchange, including a motion for summary disposition (P. MSJ), prehearing brief (P. Br.), a proposed witness list, a proposed exhibit list, and 9 proposed exhibits (P. Exs. 1-9).  DAB E-File Docket Entry Nos. 8, 8a, 9-12, and 12a-12g.  Petitioner offered the affidavits of three witnesses: 

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Cindy Gabel, Vice President of Revenue Management for Trident Health Services, who is responsible for the oversight of billing all nursing home charges at The Heights of Tomball;11 Dezarei Richey, RN-GNPBC, a geriatric nurse practitioner; and Amy Williams, Petitioner’s Administrator.  P. Exs. 4, 5, 8.  CMS filed a response opposing Petitioner’s motion for summary disposition (CMS Resp. MSJ) on August 14, 2017.  DAB E-File Docket Entry No. 13. 

This case was reassigned to me on July 24, 2019.  DAB E-File Docket Entry No. 14.  On August 8, 2019, CMS filed a motion for summary judgment (CMS MSJ), and Petitioner filed a response in opposition (P. Resp. MSJ) on September 6, 2019.  DAB E-File Docket Entry Nos. 15, 17.  On April 20, 2021, I ordered the parties to state whether they wished to cross-examine the other party’s witnesses at a hearing or, in the alternative, wished to waive an oral hearing and have the case decided on the written record.  DAB E-File Docket Entry No. 20.  On May 4, 2021, the parties responded that they wished to cross-examine witnesses and did not wish to waive an oral hearing.  DAB E-File Docket Entry No. 21.  The parties’ cross-motions for summary judgment are ripe for rulings.

II.   Admission of Exhibits into the Record

As noted above, Petitioner filed nine proposed exhibits labeled as Petitioner Exhibits (P. Exs.) 1-9.  CMS filed 29 proposed exhibits labeled as CMS Exhibits (CMS Exs.) 1-29.  CMS’ exhibits include the Declaration of Capt. McElroy, which is labeled as CMS Ex. 29.  Petitioner objects to the testimony of CMS’ witness, Capt. McElroy.  Petitioner argues that Capt. McElroy’s declaration does not constitute credible evidence and should not be given weight because he was not part of the survey team, was not physically present during any of the surveys at issue, did not write the Statements of Deficiencies (SODs), and made several erroneous statements in his declaration, which further evidences his lack of personal knowledge of the surveys at issue.  P. Br. at 12-13; P. Resp. MSJ at 10-11, 14.  Moreover, Petitioner argues that Capt. McElroy’s opinions about diabetic care are not supported by the standard of care or the treatment orders issued by the resident’s physician.  P. Resp. MSJ at 14.

Petitioner’s objections appear to concern the relevance and weight of Capt. McElroy’s testimony.  To the extent Petitioner objects to the admission of Capt. McElroy’s declaration into the administrative record, I overrule Petitioner’s objection.  Although Petitioner is correct that Capt. McElroy was not part of the survey team and, thus, lacks personal knowledge of the surveys at issue, CMS has not offered his testimony to establish the underlying facts of the case.  Rather, CMS has offered Capt. McElroy’s

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declaration as an expert opinion.  CMS Ex. 29 at 1 (testifying that “I am a Nurse Consultant employed by the Centers for Medicare & Medicaid Services (CMS), Region VI in Dallas, Texas” and explaining his education, training, qualifications, knowledge, and experience as a licensed Registered Nurse who has conducted surveys and implemented CMS’ SNF and NF enforcement regulations.); see also 81 Fed. Reg.  68,688, 68,694 (Oct. 4, 2016) (noting that “surveyors are not permitted by law to act simultaneously as consultants” in response to concerns regarding perceived inconsistencies between surveys and surveyors); Fed. R. Evid. 702 (Testimony by Expert Witnesses).  The regulations do not exclude consideration of expert opinions in this proceeding, and I find his testimony to be relevant and material.  See 42 C.F.R. § 498.60(b)(1).  Further, I may consider evidence that would be inadmissible under the Federal Rules of Evidence or other court procedures.  42 C.F.R. § 498.61.  Therefore, I overrule Petitioner’s objection and admit CMS Ex. 29 into the record.  In the absence of any further objections from either party, I also admit all remaining exhibits into the record.  Thus, Petitioner Exhibits 1 through 9 and CMS Exhibits 1 through 28 are admitted into the record.  All exhibits have been reviewed and will be accorded appropriate weight in this proceeding.

III.   Issues

The issues I must decide in this case are: 

1. Whether summary judgment is appropriate;
2. Whether Petitioner substantially complied with Medicare participation requirements at 42 C.F.R. §§ 483.10(b)(11), 483.25(c), 483.25, 483.25(d), 483.60(b), (d), (e), 483.75(l)(1), and 483.70(a) based on the October 2016 surveys and complaint investigation;
3. Whether Petitioner substantially complied with Medicare participation requirements at 42 C.F.R. §§ 483.24 and 483.25(k) and (l) based on the January 2017 complaint investigation; and
4. If Petitioner was not in substantial compliance, whether the imposed DPNA and per-day CMP amounts are reasonable.

IV.   Conclusions of Law and Analysis

My conclusions of law are set forth in bold font followed by detailed factual and legal analyses.

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A. Partial Summary Judgment Is Appropriate Because There Are No Disputed Issues of Material Fact Concerning the October 2016 Surveys and Complaint Investigation

Summary judgment is appropriate if there is “no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.”  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012) (citations omitted).  In order to prevail on a motion for summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Id.  If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial . . . .’”  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010).

In evaluating a motion for summary judgment, an ALJ does not address credibility or evaluate the weight of conflicting evidence.  Holy Cross Vill. at Notre Dame, Inc.,DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an ALJ must draw all reasonable inferences in the light most favorable to the non-moving party.  See Brightview Care Ctr., DAB No. 2132 at 2, 9-10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable).  “[A]t the summary judgment stage the judge’s function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  Cedar Lake Nursing Home,DAB No. 2344 at 7 (2010).

Here, the parties do not dispute the facts of the October 2016 surveys and complaint investigation.  In its response to CMS’ motion for summary judgment, Petitioner explained that it “has not admitted noncompliance, but has elected not to challenge the allegations made in the [October 2016] survey.”  P. Resp. MSJ at 6.  Accordingly, Petitioner has not challenged the findings of noncompliance from the October 2016 surveys.  Thus, there is no genuine issue of material fact concerning whether Petitioner was in substantial compliance based on the deficiencies cited at the October 2016 surveys.  CMS cited Petitioner for five LTC deficiencies, which resulted in a pattern (level E) or were widespread (level F), with the potential for more than minimal harm to the residents’ health or safety that is not immediate jeopardy.  CMS Ex. 11.  CMS also cited Petitioner for three LSC deficiencies, which also resulted in a pattern (level E) or

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were widespread (level F), with the potential for more than minimal harm to the residents’ health or safety that is not immediate jeopardy.  CMS Exs. 25-26.  As discussed below in section IV.C, the undisputed facts establish that Petitioner was not in substantial compliance with several Medicare program requirements at 42 C.F.R. part 483 based on the October 2016 surveys.  Accordingly, I conclude that partial summary judgment in CMS’ favor is appropriate with respect to the October 2016 surveys.

B. Summary Judgment Is Not Appropriate Concerning the January 2017 Complaint Investigation Because the Parties Dispute Material Facts

On the other hand, Petitioner disputes material facts of the January 2017 complaint investigation concerning both the care of Resident #1, an 84-year-old diabetic woman, who was hospitalized on December 10, 2016, for, among other things, hyperglycemia, and CMS’ ultimate finding that Petitioner was not in substantial compliance with Medicare program participation requirements.  CMS Ex. 1 at 5-21; CMS Ex. 2 at 1-3; CMS Ex. 6 at 104-05, 115, 119.  For summary judgment purposes, I find that the parties have presented conflicting factual evidence in support of their respective positions, which must be resolved at a hearing.  For example, CMS alleges that Petitioner’s facility failed to provide care and services to attain or maintain the highest practicable well-being in accordance with the comprehensive assessment and plan of care for Resident #1.  CMS Ex. 1 at 5; CMS Ex. 2 at 1-3; CMS MSJ at 2-3, 8-9; CMS Br. at 7-8.  Specifically, CMS alleges that Petitioner “failed to transcribe and implement the entire physician’s orders, and Resident #1’s blood sugar level was not monitored daily.”  CMS Ex. 2 at 2.  CMS also alleges that Petitioner served Resident #1 regular Coke, failed to evaluate whether Resident #1 was receiving an appropriate drink, and failed to evaluate how Coke might affect Resident #1’s blood sugar.  CMS Br. at 1, 8; CMS Ex. 2 at 5-6; CMS Ex. 6 at 106.  Further, CMS asserts that Petitioner failed to respond to Resident #1’s high blood sugar levels.  CMS MSJ at 3, 8-9; CMS Br. at 1, 7-8; CMS Ex. 2 at 3-6; CMS Ex. 6 at 68, 105-06.  In particular, CMS alleges that Petitioner failed to notify her physician when Resident #1’s blood sugar reading was 442 mg/dl on November 20, 2016.  CMS MSJ at 3, 9; CMS Br. at 3 (citing Resident #1’s clinical record and Progress Notes at CMS Ex. 6 at 68 and 105-06).  As a result, CMS alleges that Resident #1 had a change of condition on December 10, 2016, when her blood sugar level, when taken, was 500 mg/dl and when she was admitted to the hospital, where she was diagnosed with hyperglycemic hyperosmolar nonketotic coma and had a blood sugar level of 871 mg/dl.  CMS Ex. 2 at 2-3; CMS Br. at 3; CMS Ex. 6 at 118-19.  CMS further alleges that Petitioner’s failures affected 1 resident and could place the other 28 diabetic residents at risk.  CMS Ex. 2 at 3; CMS Ex. 7 at 1-2; CMS Br. at 8.  

Petitioner disputes these allegations.  Petitioner disputes whether there was a transcription error, the standard of care required for Resident #1, and whether that standard of care was

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followed.  Specifically, Petitioner disputes that daily blood sugar readings were required for Resident #1: 

While an order for daily [finger stick blood glucose] FSBG checks was written, it was never implemented.  It was discontinued and replaced with an order for weekly checks before it was implemented because the resident’s responsible party refused to allow daily blood sugar finger sticks.  (Pet. Prehearing Brief, Pet. Exs. 5, 6 and CMS Ex. 6).  The evidence reflects there was no transcription error and therefore, no injury due to a transcription error.

P. Resp. MSJ at 3; see also id. at 5; P. Ex. 5 at 5-6; P. Ex. 6 at 2.  Petitioner also asserts that Resident #1 was monitored for diabetes medication side effects and effectiveness and her blood sugar was checked weekly, in accordance with her care plan and her responsible party’s wishes, among other caregiving tasks.  P. Resp. MSJ at 3-4; P. Ex. 5 at 2; CMS Ex. 6 at 1, 12, 27, 68, 94, 98, 106, 107.Petitioner also disputes whether it was required to notify Resident #1’s physician when her blood sugar readings were elevated but below 400, asserting that “[n]either the standard of care nor the resident’s physician orders required them.”  P. Resp. MSJ at 5, 7-8; P. Ex. 5 at 2.  However, Petitioner asserts that it did notify her physician when her blood glucose reading was 442 on November 20, 2016, and had Resident #1 examined by the nurse practitioner the following day.  P. Resp. MSJ at 7-9; CMS Ex. 6 at 92.  Petitioner asserts that the “nurse practitioner’s examination and medication adjustment the following day reflect timely and prompt notification and responsive action.”  P. Resp. MSJ at 4.  Furthermore, Petitioner disputes that it served Resident #1 regular Cokes and failed to evaluate whether she was served an appropriate drink or how Coke might affect her blood sugar.  P. Resp. MSJ at 10; P. Br. at 12; see P. Ex. 8 at 1-2.  Rather, Petitioner contends that it appropriately looked into her family’s concerns about Resident #1 being served a regular Coke and determined that the regular Coke had not been on Resident #1’s tray and belonged to another individual.  P. Resp. MSJ at 10.; P. Br. at 12; P. Ex. 8 at 1-2.  Finally, Petitioner disputes that Resident #1’s change in condition on December 10, 2016, was due to a “failure to manage her blood sugar or due to any failure to notify her physician.”  P. Resp. MSJ at 6.  Instead, Petitioner contends Resident #1 had been treated for a urinary tract infection (UTI) prior to hospitalization, she was confirmed to have an E. coli UTI during her hospitalization, and, thus, “[h]er high blood sugar at the time of her hospitalization on December 10, 2016 was due to a UTI, not management of her diabetes.”  P. Resp. MSJ at 5, 10; P. Br. at 11-12; P. Ex. 5 at 3; CMS Ex. 6 at 26, 105-06, 162.  Therefore, I find that there are genuine issues for trial concerning the January 2017 complaint investigation, such as the standard of care required for Resident #1, whether Resident #1’s physician’s orders for checking her blood sugar were properly implemented, and whether Resident #1’s physician was notified when there was a change in her condition, consistent with her plan of care.  Accordingly, summary judgment is not appropriate concerning the January 2017 complaint investigation. 

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Petitioner also disputes when it returned to substantial compliance after the October 2016 surveys and whether the enforcement remedies should have been imposed.  P. MSJ at 3.  CMS asserts that “Petitioner’s noncompliance continued with the findings from the January survey, which related to failures dating back to November,” and Petitioner did not achieve substantial compliance until January 27, 2017.  CMS MSJ at 13; CMS Ex. 1 at 19.  However, Petitioner argues that it achieved substantial compliance on November 11, 2016, the date when the state agency determined that all LTC and LSC deficiencies from the October 2016 surveys were corrected.  P. MSJ at 2, 3, 5, 7 (citing Post-Certification Revisit Report attached as Exhibit A, which was entered into the record as P. Ex. 2 at 2); see also P. Resp. MSJ at 14.  Petitioner also argues that the DPNA and per-day CMPs cannot be imposed because it returned to substantial compliance before the proposed DPNA took effect on November 25, 2016.  P. MSJ at 3, 7; P. Resp. MSJ at 2, 7, 14.  In contrast, CMS argues that, “[w]hile the state certified that the health deficiencies from the October health survey were corrected prior to [November 25, 2016], the deficiencies cited as part of the life-safety code investigation were not corrected until December 2, 2016, after the November deadline.”  CMS MSJ at 12; see also CMS Resp. MSJ at 2-3.  Petitioner contends that the state agency confirmed the correction on December 2, 2016, but “it expressly found that the correction of the deficiencies was completed on November 11, 2016.”  P. MSJ at 3; P. Ex. 2 at 2.  CMS counters that correcting deficiencies “is insufficient to demonstrate that the facility returned to substantial compliance. . . . Once a facility is found to be out of substantial compliance, a facility must demonstrate not only that it has corrected the deficiencies, but also that it is capable of remaining in substantial compliance.”  CMS Resp. MSJ at 2.

Although I agree with CMS’ legal argument that correcting deficiencies is not the same as achieving substantial compliance,12 I find that when Petitioner returned to substantial compliance is a disputed fact that is material to the outcome of this case.  CMS Resp. MSJ at 2-3 (citing Meadowbrook Manor – Naperville, DAB No. 2173 at 12 (2008) and Ridgecrest Healthcare Ctr., DAB No. 2493 at 8 (2013)); see 42 C.F.R. § 488.454(a) and (e)).  While CMS argues that Petitioner’s noncompliance continued after both the October 2016 and January 2017 surveys, Petitioner argues that it returned to substantial compliance before the January 2017 survey.  As noted above, Petitioner also disputes the

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underlying facts of the January 2017 complaint investigation.  Resolution of these facts is necessary to determine whether Petitioner was in substantial compliance at the January 2017 complaint investigation, and, consequently, when the facility ultimately achieved substantial compliance after the October 2016 surveys.  In turn, resolution of when Petitioner’s facility achieved substantial compliance is material to determining whether:  (1) CMS had a basis to continue remedies imposed due to the deficiencies cited during the October 2016 surveys; (2) CMS had a basis to impose new remedies due to the alleged deficiency cited during the January 2017 complaint investigation; and (3) all of CMS’ imposed remedies are reasonable.  

C. Based on the October 2016 Surveys, Petitioner Failed to Comply Substantially with Medicare Participation Requirements at 42 C.F.R. §§ 483.10(b)(11) (Tag F-157); 483.25(c) (Tag F-314); 483.25 and 483.25(d) (Tags F-315 and 309); 483.60(b), (d), (e) (Tag F-431); 483.75(l)(1) (Tag F-514); and 483.70(a) (Tags K-25, K-69, K-72)

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(b)(11) (Tag F-157)

Program Requirement:  42 C.F.R. § 483.10(b)(11) (Tag F-157).  Each resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside of the facility.  A facility participating in the Medicare program must protect and promote the rights of each resident.  42 C.F.R. § 483.10.  Among other requirements, it must immediately inform the resident, consult with the resident’s physician, and, if known, notify the resident’s legal representative or an interested family member of:  1) an accident involving the resident which results in injury and may require physician intervention; 2) a significant change in the resident’s physical, mental, or psychosocial status (i.e., deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications); 3) a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences or to commence a new form of treatment); or 4) a decision to transfer or discharge the resident from the facility, as specified in section 483.12(a).  42 C.F.R. § 483.10(b)(11)(i)(A)-(D). 

Petitioner’s Policy.  According to Petitioner’s Psychoactive Medication Management policy, the facility must obtain a signed Psychoactive Medication Consent Form, which explains the use, reasons, and potential side effects of the medication, from the resident or the resident’s representative when the resident is prescribed a psychoactive medication.  CMS Ex. 11 at 6; CMS Ex. 23 at 38.  Additionally, Petitioner must monitor the resident’s dosage, behavior, interventions, effectiveness, and side effects.  CMS Ex. 23 at 37-39. 

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Petitioner’s Noncompliance.  The undisputed evidence of record demonstrates that Petitioner failed to immediately notify and receive proper consent for three residents who received psychoactive medications, as required by Medicare program participation requirements and Petitioner’s own policy.  CMS Ex. 11 at 2-3; CMS Ex. 23 at 38.  Specifically, Petitioner failed to notify and receive written consent from Resident #12’s representative when he was prescribed .5 mg of the psychoactive drug, brexpiprazole (Rexulti), to treat schizophrenia on September 9, 2016.  CMS Ex. 11 at 3-4; see also CMS Ex. 24 at 12, 14, 29, 30.  According to Resident #12’s clinical record,13 the consent form was signed by the resident’s sister instead of his representative.  CMS Ex. 11 at 4.  Also, Resident #67 was prescribed 50 mg of Trazodone for insomnia on September 9, 2016, ABH (Ativan, Benadryl, and Haldol) cream for agitation starting October 10, 2016, .5 mg of Alprazolam (Xanax) for anxiety/agitation starting October 11, 2016, and 7.5 mg of Olanzapine (Zyprexa) for depression on October 26, 2016.14   CMS Ex. 11 at 5-6; CMS Ex. 21 at 29-30, 34-35, 101.  However, Resident #67’s clinical record only includes a consent form for Olanzapine (Zyprexa) dated October 19, 2016.  CMS Ex. 21 at 38, 81.  His record did not include any consent forms for the Trazodone, ABH cream, Xanax, or Zyprexa (7.5 mg tablet).  CMS Ex. 11 at 5; see generally CMS Ex. 21.  Furthermore, Resident #43 was prescribed one Acetaminophen-Codeine 300-30 mg tablet every 4 hours as needed for pain on October 11, 2016.  CMS Ex. 11 at 4; CMS Ex. 18 at 50.  Her clinical record does not contain a consent form for the Acetaminophen-Codeine.  CMS Ex. 11 at 3; see generally, CMS Ex. 18.  Although Resident #43’s October 15, 2016 Minimum Data Set  (MDS) assessment stated that she received pain medications as needed or declined

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and she occasionally experienced pain of a 3 on a scale of 0-10, her care plan did not identify a pain management issue or require any pain or medication monitoring.15   CMS Ex. 11 at 4; CMS Ex. 18 at 25-26, 50, 63-71. 

CMS cited this deficiency (Tag F-157) at the scope and severity level E, which denotes a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  At the time of the October 2016 survey, 45 residents were receiving psychoactive medication and 26 residents were receiving pain medication, including Residents #12, #67, and #43.  CMS Ex. 11 at 6; CMS Ex. 13 at 2.  I agree that Petitioner’s failure to comply with regulatory requirements and its own policy with regard to Residents #12, #43, and #67 represents a pattern that had the potential to cause more than minimal harm to Petitioner’s residents because psychoactive medications are powerful drugs that must be monitored for effectiveness and potentially harmful side effects.  CMS Ex. 23 at 37-39.  Based on the evidence of record, which Petitioner does not challenge, I conclude that Petitioner was not in substantial compliance with the requirements of 42 C.F.R.§ 483.10(b)(11) and its own Psychoactive Medication Management policy because it failed to immediately notify and obtain consent when there were changes in Resident #12’s, Resident #43’s, and Resident #67’s conditions requiring a change in psychoactive medication.

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(c) (Tag F-314)

Program Requirement:  42 C.F.R. § 483.25(c) (Tag F-314).  The Quality of Care regulations require LTC facilities to provide each resident with “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.”  42 C.F.R. § 483.25.  Section 483.25(c) governs the prevention and treatment of pressure sores.  Specifically, an LTC facility must protect a resident who enters the facility without pressure sores from developing pressure sores, unless the resident’s clinical condition demonstrates that they were unavoidable.  42 C.F.R. § 483.25(c)(1).  It also requires an LTC facility to provide necessary treatment and services to a resident with pressure sores to promote healing,

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prevent infection, and prevent new sores from developing.  42 C.F.R. § 483.25(c)(2).

Petitioner’s Policy.  Petitioner’s Skin Care Management policy states that each resident must receive the care and services necessary to retain or regain optimal skin integrity to the extent possible.  CMS Ex. 11 at 14; CMS Ex. 23 at 50.  Each resident must be evaluated for risk of skin compromise or the presence of wounds and/or pressure ulcers.  A plan of care shall be developed and implemented with ongoing review.  CMS Ex. 11 at 14; CMS Ex. 23 at 50.  Risk factors for developing pressure sores include impaired/decreased mobility and decreased functional ability, co-morbidities such as diabetes mellitus, cognitive impairment, and exposure of skin to urine or fecal incontinence, among others.  CMS Ex. 11 at 14; CMS Ex. 23 at 50. 

Petitioner’s Noncompliance.  Based on the undisputed facts, Petitioner failed to provide the necessary care and services to prevent the development of pressure ulcers for two residents (Residents #34 and #51).  CMS Ex. 11 at 6-14.  On January 21, 2016, Resident #34 was admitted to Petitioner’s facility without any pressure sores.  CMS Ex. 11 at 7-8; CMS Ex. 17 at 13, 26.  However, she was assessed to be at risk for developing pressure sores due to:  occasionally moist skin requiring an extra linen change approximately once per day; severely limited ability to walk, inability to bear weight, and/or requiring assistance to move into a chair or wheelchair; inability to make frequent or significant changes in body position independently; and friction and shearing of skin to some extent against sheets, chair, restraints, or other devices.  CMS Ex. 17 at 24-25; CMS Ex. 11 at 7-8.  Her skin was noted to be dry, scaly, and fragile with a rash, abrasion, and incontinent dermatitis.  CMS Ex. 17 at 25-26.  She was noted to require limited assistance from one person with personal hygiene and was totally dependent on one person for bathing.  CMS Ex. 17 at 21-22, 33.  Resident #34 also had bowel and bladder incontinence.  CMS Ex. 17 at 23.  According to her care plan, Resident #34 sometimes refused to be bathed and had diabetes mellitus.  CMS Ex. 17 at 33-34.  Her care plan noted that she had the potential for pressure ulcers because of her immobility.  CMS Ex. 17 at 33.  Despite these warnings, Resident #34’s quarterly MDS assessment, dated August 14, 2016, stated that she had a stage 4 pressure ulcer, indicating full thickness tissue loss with exposed bone, tendon, or muscle.16   CMS Ex. 17 at 63, 66, 82; CMS Ex. 11 at 8-9; see also CMS Ex. 17 at 15 (September 1, 2016 Care Plan stating that Resident #34 had a stage 4

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pressure ulcer to her left heel).  October 2016 treatment records indicate that a heel raiser was ordered for placement under the left heel at all times while in bed, beginning June 21, 2016; weekly skin assessments started on June 23, 2016; an air mattress was ordered on July 28, 2016; daily wound care and dressing changes to the stage 4 left heel ulcer started on September 27, 2016; a nutritional supplement (Prostat) was started on September 28, 2016, for wound healing; and pain level was to be assessed prior to wound care, starting September 30, 2016.  CMS Ex. 17 at 37-38, 42-44, 50, 55, 57-60.  Resident #34’s wound care records from October 17, 2016, noted that the initial wound care consult was on June 27, 2016.  CMS Ex. 17 at 100; CMS Ex. 11 at 9.  The records also state that Resident #34’s stage 4 pressure ulcer was not healed, but was improving; she was prone to skin tears and ulcers; she was on psychiatric restraints; she had a medical history of muscle wasting; and she had bilateral lower extremity weakness and impaired mobility.  CMS Ex. 17 at 100-02, 105-06.  October 24, 2016 wound care records indicate that the stage 4 left heel pressure ulcer was acquired in-house on June 21, 2016.  CMS Ex. 17 at 103-04, 106; CMS Ex. 11 at 9.  The state agency surveyor observed an open wound to Resident #34’s left heel during the October 2016 survey and Resident #34 confirmed that the ulcer developed in Petitioner’s facility.  Resident #34 stated that it was likely due to being in bed all the time and because her heels rubbed against the sheets.  CMS Ex. 11 at 9-10; CMS Ex. 24 at 84-85, 88.

Likewise, the undisputed facts establish that Petitioner failed to prevent development of an unstageable pressure ulcer to Resident #51’s coccyx.  CMS Ex. 11 at 7.  Resident #51’s September 24, 2016 admission assessment and her MDS state that she was cognitively impaired, used a wheelchair, and was totally dependent on staff for bed mobility, transfers, eating, toilet use, personal hygiene, and bathing.  CMS Ex. 19 at 20-25, 62-63; CMS Ex. 11 at 10-11.  She was incontinent of bowel and bladder and received nutrition via gastric tube feeding.  CMS Ex. 19 at 26, 31; CMS Ex. 11 at 10-11.  She had a Brief Interview for Mental Status (BIMS) score of 0, indicating that her cognitive skills were severely impaired.  CMS Ex. 19 at 54; CMS Ex. 11 at 11.  On October 1, 2016, she was assessed to have a risk of developing pressure ulcers with a Braden Scale score of 1517 based on having bruising, very limited sensory perception, severely limited or non-existent ability to walk, very limited ability to change and control her body position independently, and a problem with friction and shear.  CMS Ex. 19 at 18-19, 27-28, 76, 86; CMS Ex. 11 at 11, 12.  She did not have any pressure ulcers at admission, and despite her Braden Scale score, she initially was assessed to not have an actual or potential risk for developing pressure ulcers.  CMS Ex. 19 at 28-29; CMS Ex. 11 at 11; CMS Ex. 24 at 96.  However, according to Resident #51’s

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care plan, dated October 10, 2016, she had a potential for pressure ulcers related to incontinence and mobility, and suffered from impaired cognition, diabetes mellitus, a right radial bone fracture with a cast on her wrist/arm, and a stage 3 pressure ulcer on her coccyx due to immobility.  CMS Ex. 19 at 93, 99-101.  She required wound care, weekly examination/treatment by the wound care doctor, and a pressure relieving/reducing mattress and cushion on her bed and wheelchair, respectively.  CMS Ex. 19 at 100-101. 

Resident #51’s medical records state that on September 27, 2016, a new skin concern was identified during her weekly skin review.  CMS Ex. 19 at 140.  On October 3, 2016, Resident #51 was seen by a wound care doctor for an incontinence-related wound on her sacrum.  The doctor assessed that the wound was expected to heal normally.  CMS Ex. 11 at 12; CMS Ex. 19 at 14-15, 132.  In addition to wound cleansing and dressing changes, the doctor ordered aggressive offloading of the wound areas at all times.  CMS Ex. 19 at 15, 125.  Resident #51 was seen again by the wound care doctor on October 10, 2016.  Although the incontinence-related wound on her sacrum had resolved, she had a second wound on her coccyx, which was identified as an unstageable pressure ulcer that was not healed.  CMS Ex. 11 at 12-13; CMS Ex. 19 at 12-13; see also CMS Ex. 19 at 16 (October 10, 2016 Nursing Weekly Skin Progress Note).  An air mattress was placed for her, beginning October 11, 2016.  CMS Ex. 19 at 124.  Two weeks later, during the October 2016 survey, the surveyor observed Resident #51 sleeping and watching TV on an air mattress with a cast on her right hand.  CMS Ex. 11 at 11-12; CMS Ex. 19 at 4.  During an interview with the wound care nurse, the nurse told the surveyor that Resident #51 had a stage III wound on her coccyx that was almost healed and that the wound developed in-house.  CMS Ex. 24 at 7; CMS Ex. 11 at 13.  Resident #51 confirmed to the surveyor that she developed the wound while in the facility, but she did not know how she got it.  CMS Ex. 11 at 12. 

According to the surveyor’s interview with the wound care nurse, all the mattresses are made for stage I and II pressure ulcers.  CMS Ex. 24 at 97; CMS Ex. 11 at 13.  Residents who develop a stage III or higher ulcer are placed on air mattresses.  Id.  At the time Resident #51 was seen by the wound care doctor for the sacrum wound, she was on a regular mattress, without any additional pressure-relieving devices, and the sacrum wound healed quickly.  Id.  The wound care nurse stated that she noticed the wound on Resident #51’s coccyx, which was pressure-related, during her weekly skin check on October 10, 2016.  Id.  She notified the doctor and received an order for an air mattress and wound care treatments.  Id.  Normally, the aides notify the nurses of any issues with the residents, but she was not notified of Resident #51’s wound on her coccyx.  Id.  According to the surveyor’s interview with the Administrator, incontinent

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residents are checked on every two hours or more often, as needed, and the aides are responsible for reporting any changes to the nurses.  CMS Ex. 11 at 13-14.

CMS cited the pressure wound deficiency (Tag F-314) at the scope and severity level E, which denotes a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  At the time of the survey, five residents had pressure ulcers and 87 residents were receiving preventive skin care.  CMS Ex. 11 at 14; CMS Ex. 13 at 1.  I agree that Petitioner’s failure to prevent pressure ulcers from developing on Residents #34 and #51 represents a pattern that had the potential to cause more than minimal harm to Petitioner’s residents.  Both residents were admitted without pressure ulcers and developed severe pressure ulcers while at Petitioner’s facility.  CMS Ex. 17 at 13, 26; CMS Ex. 19 at 29.  Although Resident #34’s conditions were assessed to put her at risk for developing pressure ulcers, proper interventions were not taken to prevent them.  For example, Resident #34’s stage 4 pressure ulcer to her heel developed on June 21, 2016, but she was not seen by the wound care doctor until nearly a week later, on June 27, 2016.  CMS Ex. 17 at 100, 103.  Even though the stage 4 pressure ulcer had been identified in June, an air mattress was not ordered until July 28, 2016.  CMS Ex. 17 at 58.  Petitioner also initially failed to code Resident #51 for potential pressure ulcers, despite her conditions making her at risk for developing then.  CMS Ex. 19 at 28.  Furthermore, Petitioner failed to prevent the unstageable pressure ulcer from developing on Resident #51’s coccyx, even though the wound care doctor had ordered “aggressive offloading” of the area when she was seen on October 3, 2016, for an incontinence-related wound on her sacrum.  CMS Ex. 19 at 15.  Resident #51 did not receive an air mattress to offload the pressure until October 11, 2016, after the new pressure ulcer on her coccyx had developed a week later.  CMS Ex. 19 at 124.  Moreover, Petitioner failed to follow its own procedures of aides notifying nurses when Resident #51 developed the pressure ulcer to her coccyx.  Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(c) based on the undisputed evidence in the record.   

3. Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.25 and 483.25(d) (Tags F-309 and F-315)18

Program Requirement:  42 C.F.R. §§ 483.25 and 483.25(d) (Tags F-309 and F-315).  As explained above, the Quality of Care regulations require LTC facilities to provide residents with the necessary care and services for residents to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in

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accordance with their comprehensive assessments and plans of care.  42 C.F.R. § 483.25.  Section 483.25(d) concerns urinary incontinence care.  The facility must ensure that a resident who enters a facility without an indwelling catheter is not catheterized unless the resident’s clinical condition demonstrates it was necessary.  42 C.F.R. § 483.25(d)(1).  The facility also must ensure that a resident who has bladder incontinence receives appropriate treatment and services to prevent UTIs and to restore as much normal bladder function as possible.  42 C.F.R. § 483.25(d)(2).

In accordance with 42 C.F.R. § 483.25(d)(1) and (2), the intent of Tag F-315 is to ensure as follows: 

• Each resident who is incontinent of urine is identified, assessed and provided appropriate treatment and services to achieve or maintain as much normal urinary function as possible;
• An indwelling catheter is not used unless there is valid medical justification;
• An indwelling catheter for which continuing use is not medically justified is discontinued as soon as clinically warranted;
• Services are provided to restore or improve normal bladder function to the extent possible, after the removal of the catheter; and
• A resident, with or without a catheter, receives the appropriate care and services to prevent infections to the extent possible.

Transmittal 8, SOM, Pub. 100-07 (June 28, 2005).  In contrast, the guidance related to Tag F-309 is “for review of quality of care not specifically covered by 42 [C.F.R. §] 483.25(a)-(m).”  Transmittal 41, SOM, Pub. 100-07 (April 10, 2009).  Among others, Tag F-309 may address deficiencies for failing to clean and secure catheters in accordance with professional accepted standards of care to minimize pulling and pain, which CMS alleges here.  Id.; see also CMS MSJ at 9; CMS Br. at 7.

Petitioner’s Policies.  Petitioner’s Indwelling Catheter Care (Daily Cleaning) policy did not address securing the catheter tubing or correct cleaning of the catheter tube.  CMS Ex. 23 at 48; CMS Ex. 11 at 19.  However, a document titled  “Nurse Aide Procedure & Skills Exam, Perineal Care/Incontinent Care-Male With or Without Catheter” states that aides must hold and support the indwelling catheter tubing “to one side to avoid traction or unnecessary movement during  procedure.”  CMS Ex. 23 at 47.  Aides must appropriately and gently wash, rinse, and dry the indwelling catheter tubing from the urethra outward.  CMS Ex. 23 at 47; CMS Ex. 11 at 18-19. 

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Petitioner’s Noncompliance.  I agree with CMS that Petitioner failed to ensure that two residents (Residents #62 and #67) who were incontinent received appropriate treatment and services to prevent UTIs and to restore as much normal bladder function as possible, in accordance with 42 C.F.R. § 483.25(d).  CMS Ex. 11 at 15 (citing the requirement of Tag F-315).  I also agree that Petitioner failed to clean Resident #62’s catheter correctly and failed to secure Residents #62’s and #67’s catheters to minimize pain and pulling, in accordance with 42 C.F.R. § 483.25.  CMS MSJ at 9 (citing Tag F-309); CMS Br. at 7 (also citing Tag F-309).  With regard to Resident #62, Petitioner failed to clean his catheter in the appropriate direction to prevent infections and failed to prevent pulling of the catheter when turning him for care, and to secure the catheter tubing to his leg.  CMS Ex. 11 at 15.  Record evidence reveals that Resident #62’s October 21, 2016 admission face sheet and October 2016 care plan did not include a diagnosis of UTI or mention catheter care.  CMS Ex. 20 at 1-2, 8-17; CMS Ex. 11 at 15-16.  However, Resident #62’s clinical record included physician’s orders, dated October 23 and 24, 2016, for catheter care.  CMS Ex. 20 at 4; CMS Ex. 11 at 16.  During the survey, the surveyor observed that Resident #62 had a catheter anchor attached to his left upper leg, but the catheter tube was not secured in place to the anchor.  CMS Ex. 24 at 86; CMS Ex. 11 at 16.  She also observed a restorative aide clean the catheter tube by wiping from the far end of the catheter tube near the connection upward towards Resident #62’s urethra, which was inconsistent with Petitioner’s policy.  CMS Ex. 11 at 16; CMS Ex. 23 at 47; CMS Ex. 24 at 86.  The restorative aide also turned Resident #62 to his “right side without removing the catheter drainage bag from the left side of the bed frame causing the tube to become tight and pull.”  CMS Ex. 11 at 16; see CMS Ex. 24 at 86.  A licensed vocational nurse who also was present reminded the restorative aide to move the bag to the other side of the bed.  CMS Ex. 11 at 16; see CMS Ex. 24 at 86. 

When interviewed by the surveyor, the restorative aide told the surveyor that she started cleaning from the bottom of the catheter tube “because she was taught to clean from clean to dirty.”  CMS Ex. 11 at 16-17; see CMS Ex. 24 at 86.  She stated that she should have moved the bag when she turned Resident #62.  CMS Ex. 24 at 86; CMS Ex. 11 at 17.  She also explained that she did not secure the catheter bag because Resident #62 refused to have it secured in place.  CMS Ex. 24 at 86; CMS Ex. 11 at 17.  The surveyor also interviewed the nurse, who confirmed that the restorative aide cleaned the catheter incorrectly by wiping in the opposite direction.  CMS Ex. 24 at 86, 88; CMS Ex. 11 at 17.  The nurse also stated that she had not heard that Resident #62 did not want his catheter secured.  CMS Ex. 24 at 86; CMS Ex. 11 at 17.  When the surveyor interviewed Resident #62, he told the surveyor that “he never told anyone he did not want his catheter secured,” and he would rather have it secured “to stop it from pulling and a lot of times it hurts.”  CMS Ex. 11 at 17; see CMS Ex. 24 at 90.

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Likewise, Petitioner failed to secure the catheter tubing to Resident #67’s leg.  CMS Ex. 24 at 91; CMS Ex. 11 at 15, 17.  Resident #67 was admitted on March 9, 2016 and readmitted on September 30, 2016, with a UTI and encephalopathy, among other diagnoses.  CMS Ex. 21 at 1; CMS Ex. 11 at 17.  Although his care plan, dated September 23, 2016, stated that Resident #67 had an indwelling catheter, no interventions were included to keep it secured.  CMS Ex. 21 at 14; CMS Ex. 11 at 17-18.  However, the care plan stated that catheter care was to be performed “per community policy.”  CMS Ex. 21 at 14, 116.  Resident #67’s October 7, 2016 MDS assessment states that he had an indwelling catheter.  CMS Ex. 21 at 39, 42, 55.  During the October 2016 survey, the surveyor observed that Resident #67’s catheter tube was not secured in place.  CMS Ex. 24 at 91; CMS Ex. 11 at 18.  During an interview, the licensed vocational nurse informed the surveyor that she took over catheter care training about a week ago and had trained the staff to start at the urethra and clean downward as had been done with Resident #67, not as the surveyor had observed with Resident #62.  CMS Ex. 24 at 92; CMS Ex. 11 at 18.  Another licensed vocational nurse interviewed by the surveyor stated that a resident’s catheter tubing must be secured in place to prevent pulling.  CMS Ex. 24 at 90; CMS Ex. 11 at 18.  The Director of Nursing also confirmed to the surveyor that catheters must be secured in place.  CMS Ex. 24 at 94; CMS Ex. 11 at 18.

CMS cited this deficiency (Tags F-309 and F-315) at scope and severity level E, indicating a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  At the time of the survey, five residents had an indwelling or external catheter, which placed them at risk for discomfort, urethral trauma, and infections.  CMS Ex. 13 at 1; CMS Ex. 11 at 15, 19.  I agree with CMS that the evidence in the record detailed above establishes that Petitioner failed to follow its own policies, to ensure that two incontinent residents (Residents #62 and #67) received appropriate catheter care, and its failures constituted a pattern with the potential for more than minimal harm.  Petitioner does not dispute these facts.  Accordingly, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.25 and 483.25(d) based on the undisputed evidence in the record. 

4. Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(b), (d), (e) (Tag F-431)

Program Requirement:  42 C.F.R. § 483.60(b), (d), (e) (Tag F-431).  Section 483.60 of the LTC regulations requires a facility to provide routine and emergency drugs and biologicals to its residents, and sets forth specific requirements concerning medication administration, records management, and the labeling and storage of drugs and biologicals.  Specifically, section 483.60(b) requires the facility to arrange for a licensed pharmacist to:  (1) consult concerning all aspects

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of the provision of pharmacy services at the facility; (2) establish a system of records for the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and (3) determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.  42 C.F.R. § 483.60(b)(1)-(3).  Section 483.60(d) requires all drugs and biologicals to be labeled in accordance with currently accepted professional principles, including appropriate accessory and cautionary instructions and expiration dates.  42 C.F.R. § 483.60(d).  Section 483.60(e) requires a facility, in accordance with state and federal laws, to store all drugs and biologicals in locked compartments under proper temperature controls, and permit access only by authorized personnel.  42 C.F.R. § 483.60(e)(1).  Controlled drugs must be locked separately in permanently affixed storage compartments, except under certain circumstances.  42 C.F.R. § 483.60(e)(2).

Petitioner’s Policies.  Petitioner’s Storage of Medication policy states that “[I]ntravenously administered medications are stored separately from orally administered medications, . . . [m]edications requiring refrigeration are kept in a refrigerator with a thermometer to allow temperature monitoring” and “[o]utdated, contaminated, discontinued, or deteriorated medications . . . are immediately removed from stock.19   CMS Ex. 11 at 22-23.  Petitioner also has a Discontinued Medication policy, which states that medications are marked as discontinued and destroyed or returned to the issuing pharmacy when the medications are discontinued by prescriber order or a resident is transferred or discharged.  CMS Ex. 23 at 41; CMS Ex. 11 at 23.  Finally, Petitioner’s “[O]peration [M]anual for the electronic emergency dispensing unit stated that there will be a regular review of the medications expiring within 90 days report and medication on the report will be replaced the next time the cabinet is restocked.”  CMS Ex. 11 at 22; see CMS Ex. 23 at 26, 31.

Petitioner’s Noncompliance.  Contrary to regulatory requirements and its own policies, Petitioner failed to ensure that drugs and biologicals were stored in accordance with state and federal laws and under proper temperature controls.  CMS Ex. 11 at 20.  Petitioner also failed to accurately monitor the temperature in the medication room refrigerator. CMS Ex. 11 at 20.  During the survey, a surveyor observed that the thermometer for the refrigerator was inside the freezer along with the freezer thermometer.  CMS Ex. 24 at 38; CMS Ex. 11 at 21.  Additionally, the daily refrigerator thermometer reading stated the temperature was 44 degrees, but the reading was actually 30 degrees, and there was no thermometer in the refrigerator.  CMS Ex. 11 at 21.  When interviewed by a surveyor, the Assistant Director of Nursing said there is supposed to be one

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thermometer in the refrigerator and one in the freezer, and the morning shift is responsible for recording both temperatures every morning.  CMS Ex. 11 at 21.  She did not know why there were two thermometers in the freezer and none in the refrigerator.  CMS Ex. 11 at 21.

Petitioner also failed to ensure that expired medications were not commingled with non-expired medications.  CMS Ex. 11 at 20.  During the October 2016 survey, a surveyor observed four IV bags of Vancomycin that had expired on September 11, 2016, mixed with non-expired refrigerated medications.  CMS Ex. 24 at 38; CMS Ex. 11 at 21.  The Assistant Director of Nursing told the surveyor that the four IV bags were for a resident who had been discharged, and they needed to be destroyed by the consultant pharmacist.  CMS Ex. 11 at 21.  Similarly, Petitioner also failed to ensure that all medications in the emergency kit were within their expiration date. CMS Ex. 24 at 34; CMS Ex. 11 at 20.  A surveyor requested a list of medications and their expiration date, and found that three medications listed by the electronic emergency medication dispensing unit had expired (Acetaminophen-Codeine, Amiodarone, and Atorvastatin) and several others were expiring in a week.  CMS Ex. 23 at 11-13; CMS Ex. 11 at 22.  Additionally, according to the surveyor’s notes, there was a discontinued antibiotic in the medication room.  CMS Ex. 24 at 29.  When interviewed, the Assistant Director of Nursing told the surveyor that the list shows “[m]edications [e]xpiring within 90 days from today,” the pharmacy representative was due to exchange the medication on the list, and the medication listed as expired had not been dispensed.  CMS Ex. 11 at 22.

CMS cited this deficiency (Tag F-431) at scope and severity level F, indicating it was widespread, with a potential for more than minimal harm to the residents’ health or safety that is not immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  I agree with CMS that Petitioner’s failure had the potential to place all 87 residents at risk of not receiving medication due to diversion or receiving discontinued or expired medications, which possibly could affect the efficacy of the medications.  CMS Ex. 13 at 1; CMS Ex. 11 at 20-21.  Based on the undisputed facts in the record, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(b), (d), and (e) because it failed to comply with the regulation and its own policies for ensuring that drugs and biologicals were stored under proper temperature controls and for marking and disposing of discontinued and expired medications. 

5. Petitioner was not in substantial compliance with 42 C.F.R. § 483.75(l)(1) (Tag F-514)

Program Requirement:  42 C.F.R. § 483.75(l)(1) (Tag F-514).  According to 42 C.F.R. § 483.75(l)(1), LTC facilities must maintain clinical records on each

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resident, in accordance with accepted professional standards and practices, that are complete, accurately documented, readily accessible, and systematically organized.  42 C.F.R. § 483.75(l)(1)(i)-(iv). 

Petitioner’s Policy.  Petitioner’s undated Medical Records Guidance states that “[a] medical record is maintained for every person admitted to a facility in accordance with accepted professional standards and practices.”  CMS Ex. 23 at 43; CMS Ex. 11 at 26.

Petitioner’s Noncompliance.  Petitioner failed to maintain complete and accurate clinical records on each resident in accordance with accepted professional standards and practices.  CMS Ex. 24 at 30; CMS Ex. 11 at 24.  Specifically, Resident #8’s clinical record did not accurately document orders and administration of Methotrexate, which placed Resident #8 and other residents at risk of having incorrect or incomplete records, which could result in medication errors or medical decisions being made based on inaccurate or incomplete information.  CMS Ex. 11 at 24.  Resident #8 was admitted into Petitioner’s facility on October 2, 2016.  CMS Ex. 15 at 13.  On October 3, 2016, Resident #8’s physician phoned in an order for 2.5 mg of Methotrexate (Methotrexate Sodium) with instructions to give 4 tablets by mouth one time a day for chronic arthritis.  CMS Ex. 15 at 86 (emphasis added); CMS Ex. 11 at 25.  However, Resident #8’s Order Summary Report states the following: 

• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day every Mon, Tue for CHEMOTHERAPY TAKE FOUR TABS ORAL ON MONDAY AND TUESDAY; Order Date:   10/02/2016; Start Date:  10/03/2016; and 
• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day every Mon, Tue for CHRONIC ARTHRITIS; Order Date:  10/14/2016; Start Date:  10/17/2016 

CMS Ex. 15 at 87 (emphasis in original); CMS Ex. 11 at 25.  Thus, Resident #8’s Order Summary Report does not accurately reflect her physician’s October 3, 2016 verbal order to take four 2.5 mg Methotrexate tablets daily for chronic arthritis.  Compare CMS Ex. 15 at 86 and CMS Ex. 15 at 87.

Resident #8’s electronic Medication Administration Record (MAR) for October 2016 included multiple orders for Methotrexate for two different indications (i.e.,

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chronic arthritis and chemotherapy).  CMS Ex. 15 at 15-18.20  Additionally, these orders appear to overlap and reflect that more Methotrexate may have been administered to Resident #8 than was ordered by her physician.  Specifically, the MAR states: 

• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day for CHRONIC ARTHRITIS; Start Date:  10/03/2016; D/C [Discontinue] Date:  10/03/2016; No administration given.21   

CMS Ex. 15 at 15, 18.

• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day for CHRONIC ARTHRITIS; Start Date:  10/04/2016; D/C [Discontinue] Date:  10/14/2016; Initialed as administered daily from 10/04/2016 through 10/14/2016.

CMS Ex. 15 at 15, 18. 

• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day every Mon, Tues for CHEMOTHERAPY TAKE FOUR TABS ORAL ON MONDAY AND TUESDAY; Start Date:  10/03/2016; Initialed as administered on 10/04/2016, 10/10/2016, 10/11/2016, 10/18/2016, 10/24/2016, and 10/25/2016.

CMS Ex. 15 at 16, 17.

• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day every Mon, Tues for CHRONIC ARTHRITIS; Start Date:  10/17/2016; Initialed as administered on 10/18/2016, 10/24/2016, and 10/25/2016.

CMS Ex. 15 at 16, 17.

• Methotrexate Tablet 2.5 mg (Methotrexate Sodium) Give 4 tablet[s] by mouth one time a day for CHRONIC ARTHRITIS;

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• Start Date:  10/03/2016; [Discontinue] Date:  10/03/2016; No administration given.  

CMS Ex. 15 at 16, 17.  Thus, Resident #8’s MAR also does not accurately reflect her physician’s verbal order to take four 2.5 mg Methotrexate tablets daily for chronic arthritis.  Compare CMS Ex. 15 at 86 and CMS Ex. 15 at 15-18.  Indeed, the final bullet above reflects an incorrect discontinuation date of October 3, 2016, and no administration of Methotrexate, even though the dose and indicated use are consistent with Resident #8’s October 3, 2016 physician’s order.  Compare CMS Ex. 15 at 86 and CMS Ex. 15 at 16, 17.

During the October 2016 survey, a surveyor observed that Resident #8 had one 30-count bubble pack container of Methotrexate marked 1 of 2, with 18 pills used and 12 pills remaining.  CMS Ex. 24 at 93; CMS Ex. 11 at 26.  Bubble pack 2 of 2 of Methotrexate was completed.  CMS Ex. 11 at 26.  The Methotrexate order was to be refilled after November 10, 2016.  CMS Ex. 24 at 93; CMS Ex. 11 at 26.  Petitioner’s pharmacy director told a surveyor that the count was correct with the number of pills that had been dispensed, and staff had administered the correct amount.  CMS Ex. 24 at 93; CMS Ex. 11 at 26.  According to the Director of Nursing, the medication order for Methotrexate had been clarified with the nurse practitioner.  CMS Ex. 24 at 94; CMS Ex. 11 at 26.  When the nurse entered the new medication order in the computer, the previous medication order should have been discontinued so it did not overlap and look like it was double administered.  CMS Ex. 24 at 94; CMS Ex. 11 at 26.  Therefore, it appears that Resident #8’s Methotrexate was administered properly, in accordance with her physician’s orders, even though the MAR appears to reflect double-administration on certain dates (e.g., October 4, 2016, and October 10, 2016) due to the appearance of overlapping orders.

CMS cited this deficiency (Tag F-514) at scope and severity level F, indicating a widespread potential for more than minimal harm to the residents’ health or safety that is not immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  At the time of the survey, there were 87 residents in the facility.  CMS Ex. 13 at 1; CMS Ex. 11 at 27.  As stated previously, Petitioner does not dispute any of the facts concerning the October 2016 survey.  I agree with CMS that the evidence in the record detailed above establishes that Petitioner failed to maintain complete and accurate clinical records for Resident #8, in accordance with regulatory requirements and its own medical records policy.  I also agree that multiple inaccuracies in a single resident’s clinical record are widespread and present a potential for more than minimal harm to all 87 residents in Petitioner’s facility.  Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.75(l)(1) based on the undisputed evidence in the record. 

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6. Petitioner was not in substantial compliance with 42 C.F.R. § 483.70(a) (Tags K-25, K-69, K-72)

Program Requirement:  42 C.F.R. § 483.70(a) (Tags K-25, K-69, K-72).  LTC facilities must be designed, constructed, equipped, and maintained to protect the health and safety of residents, personnel, and the public.  42 C.F.R. § 483.70.  In particular, LTC facilities must comply with the LSC of the National Fire Protection Association (NFPA 101), which is incorporated by reference, to protect residents, personnel, and the public from fire.  42 C.F.R. § 483.70(a)(1)(i); 42 C.F.R. § 483.70(j) (incorporating the 2012 edition of the NFPA 101 and Tentative Interim Amendments (TIA) 12-1, TIA 12-2, TIA 12-3, and TIA 12-4).  The NFPA LSC is a set of fire protection requirements that covers construction, protection, and operational features to provide occupants safety from fire, smoke, and toxic fumes. 

Relevant here, LTC facilities must comply with LSC requirements governing smoke barriers, cooking facilities, and means of egress.  NFPA 101 §§ 8.3, 9.2.3, 7.1.10, 18.3.7.3, NFPA 96; see CMS Ex. 26 at 5, 16, and 18.  Specifically, smoke barriers must be constructed to provide at least a one-hour fire resistance rating and must be constructed in accordance with NFPA 101 § 8.3.  See also NFPA 101 §§ 18.3.7.3, 18.3.7.5; CMS Ex. 25 at 1; CMS Ex. 26 at 5.  Cooking facilities must be protected in accordance with NFPA 101 §§ 9.2.3, 18.3.2.6 and 19.3.2.6 and NFPA 96.  See NFPA 101 § 9.2.3 (incorporating the protection requirements of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations); CMS Ex. 26 at 16.  NFPA 96 § 11.2.3 requires facilities to follow specific inspection, operational, and maintenance requirements for kitchen hood fire-extinguishing systems.  Specifically, exhaust fans must be activated when any appliance under the hood is turned on, and discharge nozzle caps must be in place to prevent the entrance of grease vapors, moisture, environmental contaminants, or other foreign materials into the piping.  See NFPA 96 § 11.1.1; NFPA 96 § 11.2.3 (incorporating the protection requirements of NFPA 17 and 17A); NFPA 17 § 4.3.1.5; NFPA 17A § 4.3.1.5.  Finally, means of egress must be “continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency.”  NFPA 101 § 7.1.10; see also NFPA 101 §§ 18.2.1, 19.2.1; CMS Ex. 26 at 18.  Furnishings, decorations, or other objects must not obstruct exits or the visibility or accessibility of exits.  NFPA 101 § 7.1.10.2.1; CMS Ex. 26 at 18.

Petitioner’s Noncompliance.  Petitioner does not dispute the facts establishing that it failed to meet several LSC requirements during the October 2016 survey.  During the survey, an inspector found that several smoke barrier walls had one or more open ends of pipe conduit penetrating nearby walls.  CMS Ex. 25 at 1-2; CMS Ex. 26 at 5; CMS Ex. 28 at 1.  Additionally, a pipe conduit with gray cables

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inside had a detached seal.  CMS Ex. 25 at 2; CMS Ex. 28 at 1.Due tothese penetrations in the smoke barrier walls, Petitioner failed to maintain at least a one-hour fire resistance rating.  CMS Ex. 25 at 1; CMS Ex. 26 at 5.  Petitioner’s maintenance director verified and confirmed each smoke barrier breach.  CMS Ex. 25 at 2; CMS Ex. 28 at 1.  Petitioner’s noncompliance with smoke barrier wall protections could affect the safety of all 87 residents.  CMS Ex. 25 at 1-2; CMS Ex. 13 at 1.  CMS cited this deficiency (Tag K25) at scope and severity level F, indicating it was widespread, with a potential for more than minimal harm to the residents’ health or safety that is not immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  I agree with CMS that the undisputed evidence establishes that Petitioner failed to ensure adequate smoke barrier wall protections, which was widespread and presented a potential for more than minimal harm to its residents.  Accordingly, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.70(a) based on the undisputed evidence in the record. 

The undisputed evidence also establishes that Petitioner was not in compliance with applicable cooking facilities requirements (Tag K69).  CMS Ex. 26 at 16.  The LSC surveyor documented that the range hood exhaust fan was off when cooking was in progress.  CMS Ex. 25 at 3; CMS Ex. 28 at 1.  Specifically, two burners were lit with two pots of green beans cooking on them.  CMS Ex. 25 at 3; CMS Ex. 28 at 1.  Also, one of the range hood extinguisher nozzles over the stove and grill was not capped to prevent grease build up.  CMS Ex. 25 at 3; CMS Ex. 28 at 1.  The Administrator acknowledged the issues with the range hood and stated they would be corrected.  CMS Ex. 25 at 3.  According to the Administrator’s census information, 46 residents usually ate in the dining room adjacent to the kitchen.  CMS Ex. 25 at 3-4.  CMS cited this deficiency (Tag K69) at scope and severity level E, indicating a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  I agree that the undisputed evidence establishes that Petitioner failed to follow appropriate cooking requirements for fire protection, which presented a pattern of potentially more than minimal harm.  Accordingly, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.70(a) based on the undisputed evidence in the record. 

Finally, the undisputed evidence in the record establishes that Petitioner failed to ensure that means of egress were free of obstructions at all times (Tag K72).  CMS Ex. 25 at 4.  Specifically, the LSC surveyor documented that three wide wheelchairs were parked in the corridor, blocking the exit to the laundry on hall 300.  CMS Ex. 25 at 4; CMS Ex. 28 at 1.  The wheelchairs were obstructing almost half of the corridor’s width.  CMS Ex. 25 at 4; CMS Ex. 28 at 1.  The maintenance director did not know who put the wheelchairs in the corridor.  CMS Ex. 25 at 5; CMS Ex. 28 at 1.  Also, four soiled linen barrels were obstructing the exit by the laundry.  CMS Ex. 25 at 4; CMS Ex. 28 at 1.  Petitioner’s failure to

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keep exits clear could affect the safety of all 87 residents.  CMS Ex. 13.  CMS cited this deficiency (Tag K72) at scope and severity level E, indicating a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  I agree that the undisputed evidence establishes that Petitioner failed to maintain unobstructed means of egress, which presented a pattern of potentially more than minimal harm.  Accordingly, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.70(a) based on the undisputed evidence in the record.

D. A Hearing Is Required to Determine Whether CMS’ Enforcement Remedies Are Reasonable

If a facility is not in substantial compliance with Medicare program participation requirements, CMS has authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a DPNA and per-day CMPs.  Although I have determined that Petitioner’s facility was not in substantial compliance and CMS had a basis to impose remedies because of the undisputed facts of the October 2016 surveys, I am unable to determine at this time whether the imposed remedies are reasonable.  See 42 C.F.R. §§ 488.404, 488.438(f).  As discussed above, Petitioner disputes material facts of the January 2017 complaint investigation and when it returned to substantial compliance.  P. Resp. MSJ at 6-9.  Thus, I must resolve whether Petitioner was in substantial compliance with Medicare program participation requirements at the January 2017 complaint investigation and the duration of its noncompliance before determining whether the imposed remedies are reasonable.  The parties have requested to cross-examine witnesses, and a hearing is required to resolve:  (1) the disputed material facts of the January 2017 complaint investigation; (2) when Petitioner returned to substantial compliance; and (3) whether CMS’ imposed remedies are reasonable.  Specifically, a hearing will address whether a DPNA for 63 days (November 25, 2016 through January 26, 2017), a $1,203 per-day CMP totaling $44,511, for 37 days (November 6, 2016 through December 12, 2016), and a $303 per-day CMP totaling $13,635, for 45 days (December 13, 2016 through January 26, 2017) are reasonable. 

V. Conclusion

For all the reasons discussed above, I deny Petitioner’s motion for summary judgment in its entirety and grant CMS’ motion for summary judgment, in part, as it relates to CMS’ finding that Petitioner was not in substantial compliance with Medicare participation requirements based on the surveys completed on October 27, 2016.  Accordingly, I affirm CMS’ initial determination that Petitioner failed to comply with Medicare participation requirements at:  42 C.F.R. §§ 483.10(b)(11) (Tag F-157); 483.25(c) (Tag F-314); 483.25

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and 483.25(d) (Tags F-309 and F-315); 483.60(b), (d), (e) (Tag F-431); 483.75(l)(1) (Tag F-514); and 483.70(a) (Tags K-25, K-69, and K-72).

1. CMS has revised its regulations to clarify regulatory requirements for the composition of survey teams investigating complaints.  82 Fed. Reg. 36,530, 36,623-25 (Aug. 4, 2017).
• back to note 1
2. Under the revised version of the regulations, substandard quality of care includes deficiencies at the “F,” “H,” “I,” “J,” “K,” and “L” scope and severity levels under section 483.24, Quality of life, and section 483.25, Quality of care, among other participation requirements that are not relevant here.  42 C.F.R. § 488.301.  Under the older version of the regulations, the aforementioned participation requirements were found at section 483.15, Quality of life, and section 483.25, Qualify of care. 
• back to note 2
3. CMS has adjusted the per-day and per-instance CMP amounts to account for inflation, in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016). 
• back to note 3
4. See supra n.3.
• back to note 4
5. Based on the licensing violations, the state agency recommended actions against the facility, such as the revocation, suspension, or denial of its license, and state administrative penalties.  P. Ex. 1 at 1-2.  However, the state agency’s licensing determinations are not subject to review in this forum. 
• back to note 5
6. The “Tag” designation is used in CMS Publication 100-07, SOM, Appendix PP - Guidance to Surveyors for Long Term Care Facilities, and identifies the specific regulatory provision allegedly violated and CMS’ guidance to surveyors related to the regulation.  The SOM, Appendix PP sets forth CMS policy related to health surveys.  https://www.kdads.ks.gov/docs/default-source/General-Provider-Pages/provider-statutes-and-regulations/ksa-and-kar-for-adult-care-homes/federal-regulations-for-skilled-nursing-facilities/appendix-pp---guidance-to-surveyors-long-term-care-facilities.pdf?sfvrsn=742731ee_2 (Rev. 133, effective Feb. 6, 2015) (applicable at the time of the surveys at issue); see also CMS Ex. 11.
• back to note 6
7. In its prehearing brief and motion for summary judgment, CMS states this “deficiency should have been cited at F-309, not F-315, and CMS is proceeding only with the allegation as violations of F-309.”  CMS Br. at 7 n.6; CMS MSJ at 9 n.4.  Petitioner has not objected to CMS’ change in “F” Tag designation or disputed the underlying allegations of this deficiency.
• back to note 7
8. The “K” Tag designation is used for violations cited at LSC surveys under SOM, Appendix I - Survey Procedures for Life Safety Code Surveys, and is discussed in § II, Task 5 - Information Analysis and Decision Making.  https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_i_lsc.pdf (Rev. 159, effective Sept. 9, 2016) (applicable at the time of the survey at issue).  The “K” Tags refer to the specific data tags on the Fire Safety Survey Report form completed by the surveyor.  The surveyor indicates whether each tag was “Met,” “Not Met,” or “Not Applicable.”  Id.; see also CMS Ex. 26.
• back to note 8
9. CMS’ revised Part 483 regulations also took effect between the two revisit surveys.  81 Fed. Reg. 68,688 (Oct. 4, 2016) (stating that the first phase of regulations became effective on November 28, 2016).  Thus, the October 2016 surveys are governed by the previous version of the regulations, while the January 2017 complaint investigation is governed by the revised regulations.  This ruling applies the version of the regulations in effect at the time of the respective survey(s). 
• back to note 9
10. The state agency also found that Petitioner did not meet state licensure requirements and recommended revocation, suspension, or denial of Petitioner’s license.   P. Ex. 3 at 1‑2.
• back to note 10
11. Although Petitioner offered the Affidavit of Cindy Gabel, it did not list her as a witness.  Compare P. Ex. 4 and DAB E-File Docket Entry No. 9 at 2 (Petitioner’s List of Proposed Exhibits and Witnesses, which identifies only Dezarei Richey and Amy Williams as witnesses).
• back to note 11
12. I also reject Petitioner’s legal argument that the January 2017 investigation is void and cannot serve as a basis for enforcement remedies because the survey team omitted a registered nurse.  P. MSJ at 6-7; P. Resp. MSJ at 1, 11-12.  As CMS correctly noted, the January 2017 survey was a complaint investigation that was not governed by the survey composition requirements at 42 U.S.C. § 1395i-3(g)(2).  CMS Resp. MSJ at 2-4; see also CMS Ex. 2 at 1 (SOD for the January 2017 complaint survey stating that the purpose of the visit is “[t]o conduct a complaint and incident investigation”); Avon Nursing Home, DAB No. 2830 (2017).  Furthermore, adequately documented deficiencies are not invalidated by any defect in the composition of the survey team or inadequate survey performance.  Beverly Health Care Lumberton, Ruling No. 2008-5, at 7-9 (2008).
• back to note 12
13. Although the SOD mentions Resident #12’s clinical records, the administrative record does not include any records for Resident #12.
• back to note 13
14. Resident #67 was initially prescribed .25 mg of Alprazolam (Xanax) on October 8, 2016, which was increased to .5 mg on October 11, 2016.  CMS Ex. 21 at 29-30.  Resident #67’s clinical record states that he was administered 2.5 mg of Olanzapine (Zyprexa) for insomnia on October 20, 2016, which also was increased to 5 mg on October 24, 2016, and to 7.5 mg on October 26, 2016.  CMS Ex. 21 at 35.  His clinical record also states that 10 mg of Olanzapine (Zyprexa) was prescribed and administered “one time only for screaming for 1 day” on October 26, 2016.  CMS Ex. 21 at 30.  Resident #67’s clinical records also reflect that he was prescribed and administered 5 mg of Escitalopram Oxalate (Lexapro) daily for depression on October 12, 2016, which was discontinued on October 14, 2016, and restarted at 10 mg daily on October 15, 2016.  CMS Ex. 21 at 34.  Although Resident #67’s clinical records do not include a consent form for Lexapro, CMS did not include this psychoactive medication among its allegations of failure to obtain consent for Resident #67’s change in treatment.
• back to note 14
15. CMS also alleges in passing that Resident #43’s care plan did not include any issue or monitoring of Resident #43 due to Acetaminophen-Codeine.  CMS Ex. 11 at 4; CMS Ex. 18 at 63-71.  While Resident #43’s clinical record reflects that her pain was assessed, I note that Acetaminophen-Codeine was never administered to Resident #43, and the Surveyor Notes Worksheet reflects that she was not on any psychotropic medications.  CMS Ex. 18 at 49-50; CMS Ex. 24 at 40.
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16. Although Resident #34’s January 21, 2016, admission MDS states she did not have any pressure sores, the quarterly MDS, dated August 14, 2016, states that she had a pressure sore on admission.  It is unclear whether the pressure sore actually was present at admission.  CMS Ex. 17 at 26.
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17. The SOD incorrectly states that Resident #51’s Braden Scale score was 16.  CMS Ex. 11 at 11.
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18. As noted above, CMS is proceeding under Tag F-309, and Petitioner has not objected.  However, for summary judgment purposes, I will consider this deficiency under both Tags F-315 and F-309.
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19. Although referenced in the SOD, a copy of Petitioner’s Storage of Medication policy is not in the record. 
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20. CMS Ex. 15 at 17-18 appear to be duplicate printouts of Resident #8’s electronic MAR at CMS Ex. 15 at 16 and 15, respectively, with different handwritten markings.
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21. This MAR entry was not included in the SOD.  See CMS Ex. 11 at 25.
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