Coral Reef Nursing and Rehabilitation Center, DAB CR5441 (2019)

AMENDED DECISION

Petitioner, Coral Reef Nursing and Rehabilitation Center, was not in substantial compliance with program participation requirements from January 8, 2014 through March 7, 2015. There is a basis for the imposition of enforcement remedies and the following enforcement remedies are reasonable: a civil money penalty (CMP) of $350 per day from January 8, 2014 through November 22, 2014; a CMP of $150 per day from November 23, 2014, through March 7, 2015; and a denial of payment for new admissions (DPNA) effective January 6, 2015 through March 7, 2015. 

I. Background

Petitioner is located in Miami, Florida, and participates in Medicare as a skilled nursing facility (SNF) and Medicaid as a nursing facility (NF). Joint Stipulations (Jt. Stip.) at 1 ¶ 1. On October 23, 2014, the Florida Agency for Health Care Administration (state agency) completed a recertification and complaint survey at Petitioner’s facility and found Petitioner not in substantial compliance with program participation requirements. CMS Exs. 1, 40. The Centers for Medicare and Medicaid Services (CMS) notified Petitioner by letter dated December 22, 2014, that it was imposing the following enforcement remedies: a $350 per day CMP effective January 8, 2014, and continuing until Petitioner returned to substantial compliance or its provider agreement was

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terminated; a discretionary DPNA effective January 6, 2015 and continuing until Petitioner returned to substantial compliance or was terminated; and mandatory termination of Petitioner’s provider agreement if it did not return substantial compliance by April 23, 2015. CMS Ex. 3 at 2. CMS also advised Petitioner that it was ineligible to be approved to conduct a Nurse Aide Training and Competency Evaluation Program (NATCEP) for two years. CMS Ex. 3 at 4. On December 22, 2015, CMS issued a reopened and revised initial determination. In its revised initial determination, CMS made a new allegation of noncompliance and clarified that the enforcement remedies proposed in its notice of December 22, 2014, were based on all of the noncompliance cited by the surveys completed on October 23, 2014 and the new allegation of noncompliance. CMS did not change the proposed enforcement remedies. CMS Ex. 65; Transcript (Tr.) 49-50. 

A revisit survey was completed on February 4, 2015. The surveyors determined that Petitioner had not returned to substantial compliance with program participation requirements. CMS Exs. 2, 41. On March 10, 2015, CMS notified Petitioner that the February 2015 revisit survey determined Petitioner had not returned to substantial compliance; the CMP of $350 per day ran through November 22, 2014, and was reduced to $150 per day effective November 23, 2014, and would continue until Petitioner returned to substantial compliance or was terminated; the DPNA that began January 6, 2015 continued; and termination would occur on April 23, 2015. CMS Ex. 6. 

A second revisit survey that concluded on March 23, 2015, determined that Petitioner returned to substantial compliance with program participation requirements on March 8, 2015. On April 15, 2015, CMS notified Petitioner that the discretionary DPNA ran from January 6, 2015 through March 7, 2015;1 and the termination action would not occur. CMS Ex. 7. 

Petitioner filed three requests for hearing before an administrative law judge (ALJ). Petitioner filed a request for hearing on February 13, 2015, that was docketed as C‑15‑1313 and assigned to me. Petitioner filed a second request for hearing on May 8, 2015, that was docketed as C-15-2441 and assigned to another judge but subsequently reassigned to me. Petitioner filed its third request for hearing on January 1, 2016, which was docketed as C-16-282, and it was also assigned to me. All three cases were consolidated under docket C-16-282, and the earlier docket numbers, C-15-1313 and C-15-2441, were dismissed.

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On September 19 through 21, 2017, a hearing was convened by video teleconference, and a transcript of the proceedings was prepared. CMS Exs. 1 through 772 were admitted subject to Petitioner’s continuing hearsay objections. Tr. 32-37. Petitioner offered P. Exs. 1 through 35 that were admitted as evidence. Tr. 37‑39. During the hearing, CMS offered CMS Exs. 78, 79, 80, 82, 83, and 84. Petitioner requested additional time to review the documents and, with the agreement of the parties, I deferred ruling upon their admissibility until this decision. Tr. 237-44, 255, 683-84. On September 26, 2017, CMS moved to substitute a revised CMS Ex. 84 for the copy offered at hearing. On October 4, 2017, Petitioner objected to the substitution and my consideration of the offered CMS Ex. 84 (substituted). On December 12, 2017, CMS withdrew CMS Exs. 79, 80, and 82, and moved to admit CMS Exs. 78, 83, and 84. On December 18, 2017, Petitioner objected to the admission of CMS Exs. 78, 83, and 84. Petitioner’s objections to CMS Ex. 78, 83, and 84 are sustained and the exhibits are not admitted and considered as evidence in the interest of avoiding any undue prejudice to Petitioner. CMS had sufficient time to prepare its case for hearing but failed to identify and exchange the documents in a timely manner, precluding Petitioner from examining the contents of the documents in advance of the hearing to determine how they should be tested for reliability. The late production during hearing also precluded Petitioner from deciding to subpoena any of the authors, creators, or custodians of the documents without the need to delay the hearing. CMS does not represent that it did not have access to the documents well in advance of the hearing through the exercise of due diligence. CMS’s lack of diligence in preparing its case for hearing must not be permitted to cause prejudice to Petitioner. Permitting production of substantive evidence for the first time at trial, absent extraordinary circumstances and in the face of an objection, poses more than a minimal risk of intentional delay for advantage, though the evidence does not suggest such questionable conduct occurred in this instance. Furthermore, CMS Ex. 84 is essentially an unsworn examination of Isel Lemus, Resident 1’s dentist, by counsel for CMS without the opportunity for Petitioner to cross-examine. Witnesses may only testify under oath or affirmation. 42 C.F.R. § 498.62.3 CMS did not call Dr. Lemus as a witness and offered no reason for not doing so. In fact, given the illegibility of many of Dr. Lemus’ handwritten records CMS had a significant reason to offer her testimony.4 Permitting

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counsel to offer unsworn statements of witnesses, including in the form of email, particularly in the face of an objection, poses a serious threat to the integrity of the proceedings and the quality of the evidence. Resident 1’s dental health is reflected in CMS Exs. 64 and 70, while CMS Ex. 84 adds nothing to help understand the resident’s condition, decipher the hand-written notes in CMS Ex. 64, or interpret the x-rays in CMS Ex. 70. CMS Ex. 78 is not relevant to an issue in dispute that I must decide. There is no dispute by Petitioner that it received the proceeds of the surrender of Resident 1’s insurance policy and applied all those proceeds to satisfy Resident 1’s debt to Petitioner. CMS Ex. 83, a collection of unsworn statements in the form of emails, is also not relevant. There is evidence that Petitioner ultimately reimbursed Resident 1’s family some amount. Tr. 450, 631-34. Petitioner is not alleged to be noncompliant based on how long it took to reimburse Resident 1’s family. I also conclude that any delay in the reimbursement is not appropriate for consideration of whether Petitioner was culpable for any alleged noncompliance in assessing the reasonableness of the proposed enforcement remedy. 

CMS called the following witnesses at the hearing: Surveyor Neil Walker; Ira Cheifetz, DMD; Surveyor Andrea Bailey-Dowling, Registered Dietician; Surveyor Michael J. Brown, III; Surveyor Krizia Valdees, Registered Nurse (RN); and Dinah Margaret Geneve, Nurse Practitioner (NP). Petitioner called the following witnesses: Jodi R. Ganteaume, registered dental hygienist; Leonie Love, Licensed Practical Nurse (LPN); Pearl Clarke, LPN; Maria Corchero, a registered dietetic technician; Griselda Villalta, Petitioner’s social services assistant; Ingrid Perdomo, Petitioner’s Administrator; and Nicholas J. Sabo, DDS. 

Petitioner filed its post-hearing brief (P. Br.) on December 10, 2017. CMS filed its post‑hearing brief (CMS Br.) on December 12, 2017. Petitioner filed its post-hearing

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reply brief (P. Reply) on January 9, 2018. CMS filed its post-hearing reply brief (CMS Reply) on January 11, 2018.5

II. Discussion

A. Applicable Law

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

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

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than minimal harm. 42 C.F.R. § 488.301. State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-.335. The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406.

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

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§  488.330(e), 498.3(b)(13). However, the choice of

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remedies, or the factors CMS considered when choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10)(i); see, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.” Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted). The allocation of the burden of persuasion and the quantum of evidence required to meet the burden is not addressed by regulations. Rather, the Departmental Appeals Board (Board) has long held that the petitioner, that is, the nongovernmental party, bears the burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense. Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999). The Board has indicated that only when CMS makes a prima facie showing of noncompliance, is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense. Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). The Board has not specified how much evidence CMS needs to present to meet its burden of making a prima facie showing. The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.” Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004). One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing; i.e., CMS should be burdened to present evidence sufficient to establish a fact as more likely true and to raise a presumption. However, the Board has never ruled that CMS must establish its prima facie case by a preponderance of the evidence. Indeed, it is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence. In this case, I conclude that

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CMS has made its prima facie showing by a preponderance of the evidence as discussed hereafter.

B. Issues

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

Whether the remedy proposed is reasonable.

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis. I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision. I discuss in this decision the credible evidence given the greatest weight in my decision-making.6 I also discuss any evidence that I find is not credible or worthy of weight. The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ. There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so. Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

This case involves a recertification survey and a complaint survey completed on October 23, 2014 and revisit surveys completed on February 4, 2015, for both the recertification and complaint surveys.7 The state agency surveyors recorded their findings and conclusions in four separate Statements of Deficiencies (SOD). 

Petitioner was cited for the following regulatory violations that are alleged to have posed a risk for more than minimal harm:

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Complaint Survey Concluded October 23, 2014

CMS Ex. 40 (Complaint SOD).

Recertification Survey Completed October 23, 2014

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CMS Ex. 1 (Recertification Survey SOD)

Revisit Recertification Survey Completed February 4, 2015

CMS Ex. 2 (Revisit Recertification Survey SOD).

Complaint Revisit Survey Completed February 4, 2015

CMS Ex. 41 (Complaint Revisit Survey SOD).

CMS Reopened and Revised Determination December 22, 2015

CMS Prehearing Br. at 9; CMS Ex. 65 at 2; Tr. 49-50.

Tag F151 cited by the October 2014 complaint survey involved only Resident 1. CMS subsequently added by its reopened and revised initial determination the alleged noncompliance under Tag F224 based on the same facts as alleged under Tag F151 related to Resident 1. CMS Exs. 40, 41, 65. Resident 113 was cited as an example by the surveyors under Tags F278, F309, F412 cited by the October 2014 recertification survey. The Tags related to Resident 1 are discussed together and the Tags related to Resident 113 are also discussed together. 

1. Petitioner violated 42 C.F.R. § 483.20(g)-(j) (Tag 278) and the violation posed a risk for more than minimal harm.

2. Petitioner violated 42 C.F.R. § 483.25 (Tag F309) and the violation posed a risk for more than minimal harm.

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3. Petitioner violated 42 C.F.R. § 483.55(b) (Tag F412) and the violation posed a risk for more than minimal harm.

a. Facts

Resident 113 was 90 years old at the time of the October 23, 2014 survey. Her primary language was Spanish. She was originally admitted to Petitioner in December 2005 and readmitted on April 23, 2013, following hospitalization. CMS Ex. 9 at 1, 6. A nursing social work assessment dated April 23, 2013, at the time of her readmission, indicates that she was fed by staff and she was on a pureed diet. CMS Ex. 9 at 3. According to her Minimum Data Set (MDS) with an assessment reference date of August 21, 2014, her diagnoses included coronary artery disease, hypertension, Type II diabetes, dementia, a psychotic disorder, and depression. The MDS reflected that during the assessment period she did not receive pain medication, either regularly or as needed, but a pain assessment was recommended. No dental problem was noted. She was prescribed a mechanically altered diet. During the assessment period she received antipsychotic, antidepressant, and hypnotic medications. P. Ex. 7 at 1, 4-5, 12, 17-18. The MDS shows that she could feed herself with the assistance of one person. P. Ex. 7 at 11. A prior MDS with an assessment reference date of August 22, 2013, reflected no dental problems. P. Ex. 5.  

A Medicine Service/Progress report from January 2014, states the resident had a toothache and went to see a dentist on January 8, 2014. CMS Ex. 9 at 24; P. Ex. 9 at 2. A report of consultation dated January 8, 2014, reports that a dentist found Resident 113’s lower teeth were hopeless and extraction, following medical clearance was recommended. Dr. Lemus requested medical evaluation for multiple extractions also on January 8, 2014. CMS Ex. 9 at 21-22; CMS Ex. 64 at 3-5; P. Ex. 10. A nurse’s note dated January 8, 2014, reports that medical clearance and orders were received. CMS Ex. 9 at 23; P. Ex. 19 at 4. Resident 113’s medication administration record (MAR), care plan, and physician orders shows that in January 2014, the resident was being prepared for tooth extractions. CMS Ex. 9 at 13, 17, 19; P. Ex. 6 at 20, 35; P. Ex. 24 at 5, 8. A patient progress report by Jodi Ganteaume, a dental hygienist, dated January 10, 2014, reports that Resident 113 declined to have her teeth cleaned by Ms. Ganteaume at any visit. CMS Ex. 9 at 20; P. Ex. 11. A nurse note dated January 13, 2014, indicates that Resident 113’s tooth extractions had to be rescheduled as the resident’s family wanted the extractions scheduled with a facility dentist. A nurse note dated January 21, 2014, indicates that social services was waiting on insurance verification pending a new appointment. CMS Ex. 9 at 23; P. Ex. 19 at 4. Ms. Ganteaume reported on February 14, 2014, that Resident 113 had her teeth cleaned. She reported the resident has a full upper denture and natural teeth in the lower. Ms. Ganteaume reported no missing, broken, or discolored teeth in the lower. She did not indicate how many lower teeth were present, or their health, and made no reference to any pending schedule for extraction of the lower teeth. CMS Ex. 9 at 32; P. Ex. 13. However, Ms. Ganteaume did note that Resident 113 was inquiring about having her lower teeth extracted. P. Ex. 13 at 2. Just one month

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later, on March 14, 2014, Ms. Ganteaume reported that the resident declined cleaning. P. Ex. 14. On April 8, 2014, Resident 1 was evaluated by another dentist based on a history of tooth pain and he recommended multiple extractions. P. Ex. 15. On April 25, 2014, Resident 113 again declined cleaning. P. Ex. 16. On May 30, 2014, the resident declined cleaning. P. Ex. 17. A report by Dr. Lemus dated June 19, 2014, indicates Resident 1 was seen by him again, he found her lower teeth hopeless, and he again recommended medical clearance prior to extractions. CMS Ex. 9 at 37; CMS Ex. 64 at 7; P. Ex. 18. A care plan dated August 21, 2014, assessed Resident 113 as at risk for dental/oral problems due to missing teeth. Interventions listed included speech therapy screening for chewing problems as needed, dental consult as needed, observation of signs and symptoms of pain, redness, swelling, drainage, notification of the resident’s physician of changes, and daily oral and denture care. CMS Ex. 9 at 38; P. Ex. 8 at 1. Petitioner placed in evidence an earlier and very similar care plan dated August 29, 2013, that was updated on various dates through May 29, 2014. P. Ex. 6 at 17. The care plans show that Petitioner assessed Resident 113 at risk for dental problems at least as early as August 29, 2013, though the MDS placed in evidence by Petitioner from August 2013 reflects no assessment of dental or oral problems.11 P. Ex. 5. A communication form completed by LPN Logan on October 18, 2014, reports that Resident 113 may be in need of a dental consult as she complained of mouth pain almost daily. CMS Ex. 9 at 44. A progress note by a clinical psychologist dated October 20, 2014, records a compliant of mouth pain, among other things. CMS Ex. 9 at 45; P. Ex. 9 at 8, 33. The resident’s clinical record includes a physician order dated October 23, 2014, for a dental consultation and lists a mouth sore. CMS Ex. 9 at 43. A nurse’s note dated October 23, 2014, reports mouth pain due to a mouth sore and an antibiotic and dental consultation were ordered. P. Ex. 19 at 3. A report of dental consultation dated October 27, 2014, reports Resident 113’s lower teeth are hopeless and recommends extraction after medical clearance. P. Ex. 9 at 32. A report of consultation dated November 24, 2014, shows multiple extractions of lower teeth, with extractions remaining to be done at the next visit. P. Ex. 9 at 41.

Petitioner placed in evidence MDS Health Condition forms for November 21, 2013, February 20, 2014, May 22, 2014, and August 21, 2014. P. Exs. 20-23. None of the forms report that Resident 113 had any dental problems. Comparing these forms to other clinical records for Resident 113 maintained by Petitioner, shows that the MDS Health Condition forms are not credible evidence of the condition of Resident 113’s dental health.

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Surveyor Walker participated in the October 2014 survey. He testified that he observed Resident 1 eating breakfast. He testified that he observed that she was eating on one side of her mouth. When he asked the resident why she was eating that way, she complained of pain in her mouth and a lip sore. He testified that when he interviewed Resident 113’s son, the son reported that Resident 113 had experienced discomfort in her mouth for more than a year and that he had reported that to one of Petitioner’s staff. Tr. 64-66. In his declaration, Surveyor Walker stated that he observed the resident’s bottom teeth and she had only a few remaining that were brown and broken. He also stated in his declaration that Resident 113 was drinking with a straw and he had to communicate with her through an interpreter. CMS Ex. 53 at 1-2 ¶ 5. Surveyor Walker testified that he reviewed various clinical records for Resident 113. Tr. 66-73. Surveyor Walker admitted on my examination that he is not qualified to conduct a dental examination. Tr. 74-75. He testified on cross-examination that he could not recall Resident 113 referring to pain in her teeth. Tr. 76. Surveyor Walker reviewed his notes at CMS Ex. 15 and testified that during his interview of her on October 21, 2014, Resident 113 had specifically complained of pain in her teeth, particularly when chewing, and that she had reported that to Petitioner’s staff but she felt that she was being ignored. Tr. 93-94; CMS Ex. 15 at 73. Surveyor Walker is credible. He admitted he has no expertise in dentistry but is a trained investigator who made a reasonable effort to record his observations. I am not bound by his opinions that Petitioner was deficient, but I find his testimony is generally worthy of weight as to his observations. Petitioner made continuing objection to the hearsay nature of some of Surveyor Walker’s testimony as well as to the testimony of other witnesses and documentary evidence. Hearsay may be admitted in this proceeding but it must be carefully weighed. Generally, hearsay is less persuasive than in-court testimony subject to cross-examination. However, unrebutted hearsay is given weight absent evidence it is unreliable, while rebutted hearsay is given little or no weight.

Both parties presented expert testimony for my consideration and I considered both experts qualified to render opinions in this case. CMS presented the declaration (CMS Ex. 72) and hearing testimony of Ira Cheifetz, DMD. Dr. Cheifetz opined in his declaration that when Resident 113 was seen by Dr. Lemus on January 8, 2014, the resident suffered from severely decayed teeth that were not restorable. The resident had chronic periodontal disease. CMS Ex. 72 at 4 ¶¶ 17, 19, 23. He opined that x-rays from October 27, 2014 (CMS Ex. 70)12 reveal multiple severely decayed teeth, retained roots,

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and bone loss. CMS Ex. 72 at 7 ¶ 32. He opined that Resident 113 suffered pain on account of her dental condition. CMS Ex. 72 at 7 ¶¶ 29-34. Dr. Cheifetz identified his declaration at hearing. He testified based on the x-rays (CMS Ex. 70) he reviewed that Resident 113 had broken teeth. He testified that Resident 113’s physician had also diagnosed oral sepsis multiple times in the spring of 2014. He opined that Resident 113’s teeth needed to be extracted. He opined that Resident 113 was at risk to aspirate chips breaking off her unrestorable teeth and bacteria associated with her periodontal disease. Based on his review of Resident 113’s records he determined that her lower teeth were completely removed January 25, 2015. However, he opined that there was no reason the extractions could not have been done in January 2014. Tr. 102-21. He opined that to improve Resident 113’s quality of life, her teeth should have been removed. Tr. 124. Dr. Cheifetz was recalled as a witness following the testimony of Dr. Sabo. Dr. Cheifetz opined that references to oral sepsis in Resident 113’s records were to signs of infection in the mouth of Resident 113, such as periodontitis, not a systemic infection. Tr. 222-25. Dr. Cheifetz’s opinion is credible as there is no evidence Resident 113 was suffering a systemic infection. Dr. Cheifetz opined that if Resident 113 had all her teeth removed she could probably handle a pureed diet with no teeth and her ability to chew regular food would likely be better with dentures. Tr. 226-27. He opined that the x-rays in CMS Ex. 70 showed nonfunctional teeth. Tr. 229.

Petitioner called and qualified Nicholas J. Sabo, DDS to render opinions related to general dentistry. Dr. Sabo testified he owns his dental practice known as Sheidan Dental Services. In addition to his regular practice he and his staff provide dental services in nursing homes in Florida. Tr. 159-62. He testified that his practice provides dental services at Petitioner. Tr. 163. He testified that he had seen Resident 113 as a patient but years before 2013. Tr. 166, 205. Dr. Sabo opined that hopeless teeth are unrestorable but they may still be functional. Tr. 178-79. He testified that the records show that Resident 113 did experience intermittent pain in her mouth. He testified that if a person can still chew with teeth that are whittled down, the teeth are functional. Therefore, he stated it is necessary to weigh the quality of life against what it would be without the teeth, particularly if the resident is unable to have dentures. Tr. 189-90. Although Dr. Sabo discussed decision-making related to quality of life, he does not point to any evidence that either he or another dentist actually did the assessment and concluded it was better not to extract Resident 113’s teeth. 

Petitioner also called Jodi Ganteaume, a dental hygienist employed by Sheridan Dental Services, Dr. Sabo’s practice. She testified that she provides dental hygiene services to residents in nursing homes. She provided teeth cleaning for Resident 113 once per month. She testified she saw Resident 113 for a good period before 2014 and Resident 113 did not complain of tooth pain. Tr. 464-72. Ms. Ganteaume testified that Resident 113 spoke Spanish and so it was necessary for Ms. Ganteaume to have an interpreter to have a conversation though she did understand some Spanish. Tr. 473-74, 478. Ms. Ganteaume testified that she attempted to provide teeth cleaning for Resident 113 five

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times between January and May 2014, but the resident refused all but one time. Tr. 475. Ms. Ganteaume’s last visit to Petitioner was May 2014. Tr. 477. She testified that Resident 113 had no teeth on top but had dentures. On the bottom, Resident 113 had a few teeth on the bottom. She did not recall any broken teeth and testified the resident had a tooth crown for each bottom tooth present. Tr. 480-81. She testified that Resident 113’s teeth were not perfect but not significantly bad to cause her to report to a dentist and her teeth were a normal color for someone her age. Tr. 483. Ms. Ganteaume’s opinion regarding Resident 113’s teeth is simply not credible considering the examinations done by dentists during the period of January through June 2014, and their opinions that the resident’s lower teeth were not restorable and needed to be extracted. 

Petitioner called Griselda Villalta, a social services assistant employed by Petitioner since August 8, 2014. Her job duties included setting dental and eye appointments for residents. Tr. 530-31. She testified that Resident 113’s son came to her office to report that his mother had discomfort in her mouth; he requested a dental consult; and she contacted the dental office. She could not recall the exact date but testified that it was before the survey. Resident 113’s son told her he preferred that Sheridan not be used as he felt Sheridan was not doing much for his mother. She testified that Resident 113 had never complained to her about tooth pain. Tr. 533-35. She testified that at the time of the October 2014 survey she was still working on getting a dental appointment for Resident 113. Tr. 542.

Petitioner had a policy that provided it would help residents make appointments and arrange transportation for routine and emergency dental care. CMS Ex. 9 at 7.

The surveyors cited three deficiencies, Tags F278, F309, and F412 based on the situation involving Resident 113. The deficiencies are discussed in that order. 

b. Analysis Related to Tag F278

A long-term care facility is required to conduct periodic assessments and the assessments must accurately reflect the resident’s status. An assessment must be conducted or coordinated by a registered nurse with participation of appropriate health professionals. The registered nurse must certify the assessment is complete and each person who completes a portion of the assessment must certify their portion. Certification of a material and false statement in an assessment subjects one to a CMP. 42 C.F.R. § 483.20(g)-(j). It is not alleged in this case that Resident 113’s assessments included material false statements or that they were not properly certified. However, I conclude that the assessments in evidence do not accurately reflect Resident 113’s status.

The SOD alleges that Petitioner failed to accurately assess Resident 113’s “pain and dental status” and that failure caused Resident 113 actual harm in the form of pain. CMS. Ex 1 at 6.

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Resident 113’s MDS with an assessment reference date of August 21, 2014, identifies no dental problems. P. Ex. 7 at 1, 4-5, 11-12, 17-18. A prior MDS with an assessment reference date of August 22, 2013, also reflected no dental problems. P. Ex. 5. Petitioner placed in evidence MDS Health Condition forms for November 21, 2013, February 20, 2014, May 22, 2014, and August 21, 2014. P. Exs. 20-23. None of the forms report that Resident 113 had any dental problems. Comparing these forms to other clinical records for Resident 113 maintained by Petitioner, shows that the MDS Health Condition forms are not credible evidence of the condition of Resident 113’s dental health. Petitioner’s records show that Resident 113 complained of a “toothache” and went to see a dentist on January 8, 2014. P. Ex. 9 at 2; CMS Ex. 9 at 24. The report of the dental examination on January 8, 2014, shows that the resident had no upper teeth, had an upper denture, and her lower teeth were not restorable and needed to be extracted. CMS Ex. 9 at 21-22; CMS Ex. 64 at 3-5; P. Ex. 10. Resident 113’s physician apparently agreed with the extractions and granted medical clearance on January 8, 2014. CMS Ex. 9 at 23; P. Ex. 19 at 4. On April 8, 2014, a different dentist evaluated Resident 113 for “tooth pain.” The second dentist also recommended multiple tooth extractions. P. Ex. 15. The first dentist that recommended extractions saw Resident 113 again on June 19, 2014, again finding her lower teeth unrestorable, and again recommending extraction. CMS Ex. 9 at 37; CMS Ex. 64 at 7; P. Ex. 18. Petitioner actually created care plans for Resident 113 dated August 29, 2013 and August 21, 2014, that recognized a risk for dental/oral problems due to missing teeth. P. Ex. 6 at 7; P. Ex. 8 at 1; CMS Ex. 9 at 38. I infer based on the existence of these care plans that Resident 113 was assessed for risks associated with her dental health. However, the MDS documents for Resident 113 in evidence do not reflect an assessment of dental problems for Resident 113. In fact, the evidence shows that none of the seven MDS assessments completed between July 1, 2013 and December 21, 2014, reflect any dental health problem for Resident 113.

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.20(g)-(j), because the various MDS assessments for Resident 113 do not accurately reflect her dental health status. Petitioner’s records reflect complaints of tooth pain and I accept the opinion of Dr. Cheifetz that Resident 113 likely suffered tooth pain. Therefore, I conclude that the violation posed a risk for more than minimal harm and amounted to actual harm for Resident 113. The noncompliance continued until the resident had her extractions near the end of November 2014.

Petitioner argues that Resident 113 was actually assessed for risks associated with dental health and that it had a care plan in effect. P. Br. at 6-8; P. Reply at 3-4. Certainly, Petitioner did have a care plan in effect for Resident 113 as early as August 2013, which recognized a risk associated with her dental health. Some assessment of the resident’s dental health must have occurred in order for Petitioner to identify the risk and the need for the care plan. Petitioner’s problem, however, is that its MDS forms from July 2013 through the October 2014 survey do not accurately reflect Petitioner’s assessment of

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Resident 113’s dental risks and that is the basis for concluding that there was a violation of 42 C.F.R. §  483.20(g)-(j). Petitioner also makes various assertions of fact that are simply unsupported by the record and inadequate to rebut the CMS prima facie showing. P. Br. at 6-8; P. Reply at 3-4. Petitioner’s own records show that Resident 113 complained of pain in January 2014 and the dentist who did the examination, while not describing specifically how the bottom teeth looked, clearly declared those teeth hopeless or not restorable. A second dentist confirmed the diagnosis and the necessary treatment. Petitioner’s reliance upon Jodi Ganteaume who purportedly cleaned Resident 113’s teeth in February 2014 is misplaced as she is simply not credible. Ms. Ganteaume admitted that she did not speak Spanish but she only occasionally found someone to interpret. Therefore, I have no level of confidence that Ms. Ganteaume could either ask Resident 113 about her condition or understand a response. Further, Ms. Ganteaume’s notes are clearly superficial and not detailed as she failed to record her actual observations or assessment of teeth in February 2014, that a dentist had declared not restorable in January 2014 and that a different dentist had declared not restorable in April 2014. Therefore, Ms. Ganteaume’s recollection of the condition of Resident 113’s teeth is not reliable or weighty. The fact that Ms. Ganteaume did not report any complaint of pain by Resident 113 or note any problems with Resident 113’s lower teeth is also not weighty. Because Ms. Ganteaume did not ask and did not record why Resident 113 declined her services on multiple occasions, it is equally possible to infer that Resident 113’s teeth bothered her or that cleaning by Ms. Ganteaume caused discomfort – inferences I am not willing to draw based on the evidence in the record. I conclude that Petitioner has not rebutted CMS’s prima facie case that Petitioner’s MDS assessments for Resident 113 from July 2013 through the October 2014 survey did not show Resident 113 was at risk for harm due to her dental health.

c. Analysis Related to Tag F309

Pursuant to 42 C.F.R. § 483.25:

Each resident must receive and the facility must provide 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.

The surveyors allege under Tag F309, that Petitioner violated 42 C.F.R. § 483.25 and the violation posed a risk for more than minimal harm with actual harm suffered by Resident

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113.13 Specifically, with regard to Resident 113, the surveyors allege that Petitioner failed to coordinate care among disciplines related to preventing Resident 113 from suffering tooth pain; failed to adequately assess Resident 113’s pain; and did not implement effective interventions to address the pain.14 CMS. Ex 1 at 13-14. 

Dr. Lemus examined Resident 113 on January 8, 2014. She determined the resident’s remaining lower teeth were hopeless and the treatment recommended was extraction of the resident’s lower teeth. CMS Ex. 9 at 21- 22; CMS Ex. 64 at 3-5; P. Ex. 10. On April 8, 2014, Resident 113 was evaluated by another dentist and he also recommended multiple extractions. P. Ex. 15. Dr. Lemus evaluated Resident 113 again on June 19, 2014, and again planned for multiple extractions of the resident’s hopeless teeth. CMS Ex. 9 at 37; CMS Ex. 64 at 7; P. Ex. 18. Another dental consult conducted on October 27, 2014, also reported Resident 113’s lower teeth were hopeless and recommended extractions. P. Ex. 9 at 32. Dr. Cheifetz, reviewed at least part of Resident 113’s clinical records, and opined that Resident 113’s lower teeth needed to be extracted and were likely a source for pain. Tr. 102-21. Only Dr. Sabo, who owned the practice providing dental services to Resident 113 during part of the period from January 2014 to the October 2014 survey, implied that Resident 113 might be better off with her natural teeth, if they were functional. Tr. 163, 178-79, 189-90. However, Dr. Sabo did not actually opine, based on an examination by him or the resident’s records, that Resident 113 had a better quality of life with her lower teeth during the period January 2014 until her teeth were actually extracted in November 2014 and January 2015. Ms. Ganteaume, the dental hygienist employed by Dr. Sabo’s practice who performed a cleaning in February 2014, was not qualified as an expert in general dentistry and provided no opinion as to Resident 113’s highest practicable well-being based on her dental health. I can infer nothing from Ms. Ganteaume’s testimony or the records she made that are in evidence as they are imprecise, unclear, and reflect very little about what she actually saw in Resident 113’s mouth.

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Petitioner was obliged by the regulation to ensure that Resident 113 received “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. § 483.24. Two dentists determined after three different examinations of Resident 113, that extractions of Resident 113’s teeth were necessary and appropriate treatment. Dr. Cheifetz concurred with the determinations that extractions were necessary and appropriate. I infer that the three doctors determined that extractions were necessary for Resident 113’s well-being. Petitioner has failed to rebut the evidence that extractions were necessary. Dr. Sabo did not offer a conflicting opinion only suggesting it is better to retain functional natural teeth. Ms. Ganteaume’s testimony and the records she created, while relevant, have very little weight for the reasons already identified. 

I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25 and that violation posed a risk for more than minimal harm and caused actual harm to Resident 113 based on evidence in the clinical record maintained by Petitioner that she suffered pain in her mouth. Petitioner has not shown the mouth pain was more likely than not attributable to a cause other than the resident’s lower teeth.

Petitioner does not deny the surveyor observed Resident 113 in pain. Petitioner argues that the resident’s pain was caused by a mouth sore or a canker sore, not Resident 113’s bad teeth. P. Br. at 11. Surveyor Walker actually observed a sore in Resident 113’s mouth. However, Petitioner has presented no evidence that the pain of which Resident 113 complained was actually evaluated and determined to be caused by the mouth sore. Similarly, with regard to the early complaints of tooth and mouth pain in the record, Petitioner has not presented evidence of an assessment or evaluation that attributes the complaints to sources other than the resident’s teeth. In fact, the evidence shows that the complaint of tooth pain in January 2014, triggered Dr. Lemus’s evaluation and she determined that extraction of the resident’s lower teeth was the appropriate plan of treatment.

Petitioner also relies upon its arguments under Tag F278. P. Br. at 10-11. Petitioner’s arguments do not satisfy its burden for the reasons already discussed under Tag F278. There is evidence that Resident 113 complained of tooth pain in January 2014. Two dentists examined the resident and concluded extraction of her lower teeth was necessary. Petitioner bears the burden to show by a preponderance of the evidence that it did not fail to deliver necessary care and services. Petitioner failed to meet its burden. 

Accordingly, Petitioner violated 42 C.F.R. § 483.25 and the violation caused actual harm to Resident 113.

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d. Analysis Related to Tag F412

A long-term care facility is required to assist residents in obtaining routine and emergency dental care. 42 C.F.R. § 483.55. A nursing facility such as Petitioner is required to provide or obtain routine dental services to the extent covered by the state plan and emergency dental services to meet the needs of each resident. 42 C.F.R. § 483.55(b). A facility is required to assist a resident in making dental appointments and arranging transportation. 42 C.F.R. § 483.55(b)(2).

The surveyors allege that the facility failed to provide dental services to Resident 113 and that caused actual harm to the resident. CMS Ex. 1 at 29. I conclude CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.55.

Petitioner’s records for Resident 113 show she complained of a toothache in January 2014. CMS Ex. 9 at 24; P. Ex. 9 at 2. The resident was evaluated by Dr. Lemus on January 8, 2014, who determined that the resident’s lower teeth were hopeless and needed to be extracted. CMS Ex. 9 at 21-22; CMS Ex. 64; P. Ex. 10. Another dentist evaluated Resident 113 on April 8, 2014, based on a history of tooth pain and he also recommended extractions. P. Ex. 15. On June 19, 2014, Dr. Lemus evaluated Resident 113 again and again determined that extraction of the resident’s lower teeth was the appropriate treatment. CMS Ex. 9 at 37; CMS Ex. 64 at 7; P. Ex. 18. Therefore, the evidence shows that as early as January 8, 2014, a dentist determined that Resident 113 was in need of dental treatment that was not delivered as of the October 2014 survey. There is some evidence that Resident 113 made scheduling the extractions difficult, however, the evidence does not show that Petitioner’s staff actively intervened with Resident 113 and her family to ensure that the extractions were accomplished promptly as ordered in January and recommended in April and June 2014.

Petitioner argues that Resident 113 was not suffering a dental emergency on January 8, 2014, when she was seen by Dr. Lemus; the evidence does not show Resident 113 was having tooth pain; and there was no pathology that constituted an emergency. Petitioner argues that the same was true when Resident 113 saw the second dentist on April 8, 2014, and the resident declined treatment that day. Petitioner also argues that the three visits to the dentists and the visits from the dental hygienist show that Petitioner was assisting Resident 113 to obtain dental care. P. Br. at 16-18; P. Reply at 1-5. Petitioner is required to assist its resident in obtaining both routine and emergency dental care. 42 C.F.R. § 483.55. Resident 113 had three dentist visits in January, April, and June 2014, and each time it was recommended that the resident needed her lower teeth extracted. Although Petitioner did help Resident 113 obtain the dental appointments and dental hygiene visits, Petitioner failed to help Resident 113 have her teeth extracted until after the October 2014 survey. Petitioner has not offered evidence that, following either the January, April, or June 2014 dental evaluations, Petitioner’s staff attempted to meet with the resident and her son to facilitate scheduling the extractions or that Petitioner’s staff

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intervened in any other way to encourage the resident and her family to have the extractions done. There are no nurse notes, progress notes, other clinical records, or quality assurance notes that show Petitioner’s staff attempted to work with the resident and her son to ensure prompt scheduling of the canceled extractions in January, April, or June 2014. Petitioner failed to even add the needed extractions to the resident’s dental care plan so that staff would be aware and encourage the resident. CMS Ex. 9 at 38; P. Ex. 6 at 17; P. Ex. 8 at 1. I conclude that Petitioner has failed to meet its burden to rebut the prima facie showing by CMS.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.55; the violation posed a risk for more than minimal harm; and the failure to extract the resident’s teeth resulted in unnecessary pain, which is actual harm. 

4. Petitioner violated 42 C.F.R. § 483.10(a)(1), (2) (Tag F151) and the violation posed a risk for more than minimal harm.

5. Petitioner violated 42 C.F.R. § 483.13(c) (Tag F224) and the violation posed a risk for more than minimal harm.

The alleged violation of 42 C.F.R. § 483.10(a)(1), (2) (Tag F151) was cited by the complaint survey completed on October 23, 2014 and the revisit to the complaint survey completed on February 4, 2015. CMS Exs. 40, 41. The alleged violation of 42 C.F.R. § 483.13(c) (Tag F224) was alleged by the reopened and revised determination of CMS dated December 22, 2015. Resident 1 was the only resident involved under Tags F151 and F224.

a. Facts

The October 2014 complaint survey was triggered by a complaint to the state agency by Resident 1’s daughter that Petitioner caused a resident with dementia to sign a document that allowed Petitioner to obtain the cash value of his life insurance policy. The complaint summary states “[t]he caller is upset because he [Resident 1] did have the mental capacity to do so.” CMS Ex. 42. It appears that the complainant may have alleged that Resident 1 did not have capacity to sign over his life insurance and that the complaint summary is in error in that regard.

Resident 1 was originally admitted to Petitioner on April 6, 2012 and readmitted on March 15, 2013. He was 82 years old at the time of the October 2014 survey. His records indicate that at the time of readmission he had coverage by both Medicare and Medicaid. His responsible party was listed as “MG,” his daughter. He had a diagnosis of organic brain syndrome among others. CMS Ex. 46.

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On April 6, 2012, MG signed as Resident 1’s legal representative or legal guardian an admission agreement and other documents detailing resident rights. CMS Ex. 45 at 1, 16-17, 23. MG agreed that she and Resident 1 were responsible for any charges not covered by Medicare, Medicaid, or third-party insurance. CMS Ex. 45 at 2. MG agreed to pay a deposit to be placed in an interest-bearing account in Resident 1’s name and authorized Petitioner to apply the deposit to any outstanding financial obligations at Petitioner’s discretion. CMS Ex. 45 at 3. MG agreed to turn over to Petitioner all Resident 1’s income when he was covered by Medicaid. MG also agreed that she and Resident 1 were responsible for all charges during any period that Resident 1 was ineligible for Medicare or Medicaid. CMS Ex. 45 at 4-5. MG agreed that she and Resident 1 were liable to pay any charges Medicare, Medicaid, or a third-party refused to pay or that were for services not otherwise covered. CMS Ex. 45 at 5-6. MG agreed that Petitioner was authorized to file any change of address to ensure Resident 1’s Social Security, pension, and other checks would be sent directly to Petitioner for deposit in the resident’s deposit account. MG agreed that she or Resident 1 would sign appropriate documents to enable direct deposit of all Resident 1’s income into the bank account designated by Petitioner. CMS Ex. 45 at 9. MG also agreed that Resident 1 authorized Petitioner to apply any accumulated funds in his personal needs account to pay any debts he incurred. CMS Ex. 45 at 12. MG agreed to be bound by the agreement. CMS Ex. 45 at 16. 

Resident 1’s MDS with an assessment reference date of April 6, 2014, assessed the resident as having unclear speech with slurred or mumbled words; he rarely or never understood others during the assessment period; it was questioned whether he had highly impaired object identification but his eyes were noted to follow objects; he could not be interviewed because he was rarely or never understood; his long-term and short-term memory were impaired; his cognitive skills for daily decision-making were rated as severely impaired and he never or rarely made decisions; he required staff assistance, extensive staff assistance or was totally dependent on staff for most activities of daily living; listed diagnoses included non-Alzheimer’s dementia, a psychotic disorder other than schizophrenia, and limited vision due to cataracts; his prescription medications included two antipsychotics; and notes indicated severe cognitive impairment and highly impaired vision. CMS Ex. 47.

Physician progress notes dated January 14, February 24, April 8, and May 9, 2014, show a diagnosis of dementia and treatment with Haldol for psychosis. CMS Ex. 48 at 1-2, 4-5. A psychiatric progress note dated April 3, 2014, lists the same diagnoses and medication. CMS Ex. 48 at 3. A psychiatric progress note dated July 29, 2014, reported Resident 1 had severe cognitive impairment including long-term and short-term memory impairment, and that he was on the lowest dose of psychotropic medication. CMS Ex. 48 at 6.

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CMS placed in evidence a Prudential Insurance Company form titled “Request to Surrender Policy.” The form is completed to have the check for the surrendered policy made payable to Resident 1 and sent to Petitioner’s address. Tr. 649. The form is dated May 18, 2014, bears a notary seal, and there is no dispute that the purported signature was made by Resident 1. CMS Ex. 49. CMS also placed in evidence a letter signed by a physician dated May 18, 2014, that certifies that Resident 1 was “alert and oriented” and “capable of making decisions on his own,” but his ability to sign his name was affected by his medical condition. CMS Ex. 50. CMS Ex. 51 is a letter from Prudential indicating that Resident 1’s insurance policy was surrendered and the proceeds of $19,131.01 were paid by check payable to Resident 1. The check was endorsed and cashed by Petitioner. CMS Ex. 51 at 1, 4. CMS Ex. 52 is a copy of a prepaid burial plan that was purchased by MG on January 24, 2014, for $8,740. CMS Ex. 52. The parties stipulated that Petitioner received the check from Prudential and the check was “deposited in Petitioner’s bank account.”15 Jt. Stip. at 2 ¶ 12. 

Surveyor Walker conducted the complaint survey on October 20 through 23, 2014, related to Resident 1. After attempting to interview Resident 1 and reviewing the resident’s records, Surveyor Walker concluded the resident was not competent to decide whether to surrender his life insurance policy. Tr. 63; CMS Ex. 53 at 2 ¶¶ 10-13.

CMS placed in evidence the declaration of MG, the daughter of Resident 1 (CMS Ex. 54) and elicited her testimony at hearing (Tr. 419). MG testified in her declaration that no guardian was appointed for her father but she had been his representative since he was admitted to Petitioner. She signed all admissions forms for Petitioner because her father could not do so. Medicare originally covered services for her father but when they stopped Petitioner applied for Medicaid on Resident 1’s behalf. Petitioner’s staff subsequently advised her that her father did not qualify for Medicaid because he owned a life insurance policy with Prudential Insurance Company with a cash value of approximately $19,000. She contacted Prudential to determine the cash surrender value and procedure for surrendering the policy. She later learned Petitioner also contacted Prudential and obtained a cash surrender form that Petitioner returned to Prudential purporting to bear her father’s signature and dated May 18, 2014. Prudential paid Petitioner $19,131.01 by check dated June 3, 2014. MG testified that she told Petitioner

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that her father had a funeral and burial policy that cost approximately $8,900, which she purchased on January 24, 2014. She testified that she requested that Petitioner give her the cost of the funeral and burial policy from the life insurance proceeds. After she learned that Petitioner had cashed the life insurance policy, she contacted Petitioner’s business manager to remind them of the $8,900 funeral and burial policy but she was told it was too late because the proceeds had been applied to the debt her father owed to Petitioner. She testified she did not give Petitioner permission to cash the policy or apply the proceeds to outstanding debt. CMS Ex. 54 at 1-2, ¶¶ 2-9, 10-11. During her testimony at hearing, she agreed that she signed the admission agreement (CMS Ex. 45) when her father was admitted to Petitioner. She believed that it was her responsibility as the responsible party to make financial decisions on behalf of her father. Tr. 425-26. She was aware that Petitioner applied for Medicaid for her father. However, Medicaid stopped paying in October 2013, because he owned the life insurance policy with a cash value. She testified she provided Petitioner with a copy of the policy. She met with a Medicaid representative who confirmed that Resident 1’s Medicaid was terminated because of the cash value of the life insurance policy. The Medicaid representative suggested buying an irrevocable death benefit policy when the life insurance policy was surrendered with the remainder to go to his debts. MG testified that she did agree to purchase a funeral and burial policy in January 2014. Tr. 428-30. She testified that she intended for the policy to be paid for with some of the insurance policy surrender proceeds and she advised one of Petitioner’s staff, Adriana,16 who agreed. Tr. 436-37. She subsequently learned that Petitioner had submitted the policy surrender documents to Prudential, a check was issued to Petitioner, and the check was cashed without her knowledge. She felt that Petitioner’s staff was nasty to her when she questioned them about what happened. Tr. 442-45. Following the first revisit survey, Petitioner did pay MG the cost of the prepaid funeral and burial policy. Tr. 450.

Petitioner’s Administrator, Ingrid Perdomo, testified that the state agency had come to Petitioner previously about the complaint related to Resident 1 and his life insurance policy proceeds and found that complaint unsubstantiated. She testified that Petitioner assisted Resident 1 apply for Medicaid so that he could stay in the facility but he had the life insurance policy that had to be surrendered. She testified that she personally spoke with MG and MG was informed that Petitioner was applying for Medicaid for her father and that the life insurance policy had to be surrendered for him to qualify. MG gave the business office manager the Prudential Insurance contact information and the business office manager obtained the necessary form. Administrator Perdomo testified that she explained to MG that MG’s father had to sign the form and the Administrator was going to take care of that. She explained that Resident 1’s first language is Creole so she took a

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Creole speaking certified nursing assistant (CNA) with her to speak to Resident 1. She had the CNA explain to Resident 1 that if he wanted to stay at Petitioner, he had to sign the form in order to qualify for Medicaid. Her understanding was that the entire amount of the cash surrender value of the policy was to be used for Resident 1’s care and to get him approved for Medicaid. Resident 1 signed the form. Prudential Insurance questioned the signature on the surrender form, so she obtained a physician’s statement about how his medical condition affected his signature. Prudential paid after receiving the physician’s statement and the amount of the check, approximately $19,000, was deposited in Resident 1’s patient trust account and subsequently applied to his outstanding debt to Petitioner. Resident 1 was subsequently approved for Medicaid. Tr. 615-28. She testified that she believed Petitioner was found not to have returned to compliance during the revisit survey because they had not refunded any money to Resident 1 or his responsible party. Tr. 629. She testified on cross-examination that Petitioner did refund approximately $8,000 for the prepaid funeral and burial policy. She testified that had she known about the situation at the time of the disbursement of the insurance policy surrender, MG would have been paid then. Tr. 632-34. She testified at the time Resident 1 signed the surrender form, she was not aware that he had been assessed as significantly cognitively impaired. Tr. 645-46. She testified that she had no reason to think Resident 1 did not understand what he was being asked to do when he signed the surrender form. Tr. 655.

b. Analysis Related to Tags F151 and F224

The complaint survey completed October 23, 2014 (CMS Ex. 40), and the complaint revisit survey completed February 4, 2015 (CMS Ex. 41), allege based on the foregoing facts noncompliance under Tag F151 based on a violation of 42 C.F.R. § 483.10(a)(1) and (2) that posed a risk for more than minimal harm with no actual harm or immediate jeopardy. 

On December 22, 2014, CMS issued its initial determination in this case in which it advised Petitioner it was imposing enforcement remedies based on the noncompliance identified by the state agency during the surveys completed on October 23, 2014. CMS Ex. 3. Pursuant to 42 C.F.R. § 498.30, CMS may reopen any initial or reconsidered determination “within 12 months after the date of notice of the initial determination.” On December 22, 2015, exactly 12 months from the issuance of its initial determination, CMS reopened its December 22, 2014 initial determination and revised that determination. CMS clarified in its reopened and revised initial determination the basis for imposing enforcement remedies. CMS also advised Petitioner that it determined that, based on the survey findings from October 23, 2014, Petitioner also violated 42 C.F.R. § 483.13(c) and that violation amounted to noncompliance under Tag F224, though CMS did not specify the scope and severity. CMS Ex. 65 at 2. CMS clarified during the hearing that the alleged violation of 42 C.F.R. § 483.13(c) was for misappropriation of Resident 1’s money and based on the same facts alleged in the SOD for the compliant

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survey and revisit. Tr. 49-50. There is no question that CMS timely acted within its authority to reopen and revise its initial determination and the alleged noncompliance under Tag F224 is properly before me for consideration.17 Petitioner disputes that there was any noncompliance related to Resident 1. However, Petitioner does not allege that CMS was without authority to reopen and revise and add Tag F224 as it relates to Resident 1 to the charge. Petitioner does not challenge, except for a lack of precision, the adequacy of the notice of the reopened and revised determination. P. Br. at 20. I conclude that notice of the reopened and revised determination satisfied the requirements of 42 C.F.R. § 498.30. Further, Petitioner had the opportunity to address the charge at hearing and in post-hearing briefing.  

I conclude that Tag F151 and Tag F224 are both properly before me and that it is most efficient to discuss the Tags together. Pursuant to 42 C.F.R. § 483.10, Petitioner must protect and promote the rights of each resident, including rights associated with being a resident and/or citizen of the United States. 42 C.F.R. § 483.10(a)(1). Though not specifically referenced in the SOD, one of the rights Petitioner must protect is the right of the resident to manage personal funds. Act § 1819(c)(6). The regulation specifies that a resident has the right to manage his or her personal financial affairs, assuming the resident is not adjudged incompetent to do so. The regulation is also specific that Petitioner may not require residents to deposit personal funds with the facility. If a resident authorized Petitioner to hold his or her funds, Petitioner is required to “hold, safeguard, manage, and account for” the resident’s personal funds. 42 C.F.R. § 483.10(c). Neither the state agency nor CMS alleged a violation of 42 C.F.R.

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§ 483.10(c) based on the admission agreement Resident 1’s personal representative executed in this case.18

The surveyors allege in the SOD for the complaint survey completed on October 23, 2014, that Petitioner violated Resident 1’s right by not ensuring he was cognitively aware prior to having him sign a document that affected his financial interest. Although there is no SOD citing Tag F224, the CMS theory is that the same facts show Petitioner misappropriated a portion of the proceeds of the surrender of Resident 1’s life insurance policy by failing to ensure he was cognitively aware when he signed the surrender form. A skilled nursing facility participating in Medicare must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property. 42 C.F.R. § 483.13(c). Misappropriation of resident property is defined as the deliberate “misplacement, exploitation or wrongful, temporary or permanent use of a resident’s belongings or money without the resident’s consent.” 42 C.F.R. § 488.301. 

I conclude that Petitioner violated both 42 C.F.R. §§ 483.10(1)-(2) and 483.13(c) beginning on May 18, 2014, when Petitioner’s Administrator obtained the signature of Resident 1 on a Prudential life insurance surrender form (CMS Ex. 49), and that the violation caused a risk for more than minimal harm. 

On April 6, 2012, Petitioner and Resident 1’s representative, MG, entered an admission agreement and other documents detailing the resident’s rights while he was a resident at Petitioner’s facility. CMS Ex. 45 at 1, 16-17, 23. MG agreed to many things, including that she and the resident were financially responsible for any charges not covered by Medicare, Medicaid, or third-party insurance; to pay a deposit to be held by Petitioner in an interest bearing account in the resident’s name; that any funds in the account in the resident’s name could be applied to any outstanding financial obligation to Petitioner; to

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turn over all Resident 1’s income to Petitioner when he was covered by Medicaid; and authorized Petitioner to file changes of address and direct deposit forms for the resident with Social Security, pension, Medicare, Medicaid, and other sources of income to ensure all income went to the account held by Petitioner in the resident’s name and that the resident would sign such forms. CMS Ex. 45 at 1-17. Neither the state surveyors, nor CMS, cited this contract as a violation of any statutory or regulatory provision and I have no evidence upon which I could decide that the contract was not lawful and enforceable. 

It is clear from the evidence, that although he had not been declared incompetent to manage his own affairs and no guardian was appointed, Petitioner recognized MG as Resident 1’s representative and entered a contract with her to provide care of Resident 1 in exchange for promised compensation. The fact Petitioner had MG execute the admission agreement is good evidence that Petitioner recognized it could not rely upon Resident 1 to sign a binding agreement with which he could comply. Further, Petitioner’s clinical records for Resident 1 clearly show that he had severe cognitive impairment due to his dementia and psychosis. CMS Ex. 47; CMS Ex. 48 at 1-6. Petitioner placed in evidence a letter signed by Yasser Asmar-Fernandez, MD dated May 18, 2014, in which he states that Resident 1 was capable of making decisions on his own. P. Ex. 27. Dr. Fernandez stated that the resident was “oriented x 1” which means he knew his name and significant others. Dr. Fernandez did not state when he last saw the resident or assessed his cognitive ability or specify the bases for his opinion. Dr. Fernandez also does not specify what decisions Resident 1 was capable of making, for example whether or not to have ice cream or agree to a financial transaction. Considering the April 6, 2014 MDS and the other clinical evidence related to Resident 1’s cognitive status and the lack of clarity of the bases and limitations of Dr. Fernandez’s opinion, I conclude his opinion is of little weight in the case. The resident’s MDS for the period ending April 6, 2014, clearly showed the resident’s severe cognitive impairment. CMS Ex. 47. Nevertheless, on about May 18, 2014, Petitioner went to some lengths to get Resident 1 to sign a Prudential Insurance Company form to surrender a life insurance policy he owned valued at $19,131.01. There is no dispute that MG was not present for the signing and was not aware that the form had been submitted to Prudential with changes that resulted in the check being sent to Petitioner for deposit in the account in the resident’s name. There is also no dispute that MG also previously attempted to get Resident 1 to sign the form and he refused. Tr. 437. I infer from the evidence, that absent Resident 1’s signature or a declaration by a competent authority that he was incompetent to sign, Prudential was unlikely to pay anyone the value of the insurance policy. P. Reply at 6. Neither MG nor Petitioner saw fit to expend the time or money necessary to declare Resident 1 incompetent which no doubt would have used a substantial portion of the surrender value in legal fees. Rather both parties attempted to get Resident 1 to sign despite his severe cognitive limitation, i.e., whether he was competent to sign or not. Prudential issued a check for $19,131.01, which Petitioner deposited in or credited to Resident 1’s personal needs or trust account. Jt. Stip. ¶ 12.

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Petitioner then applied the entire amount to the resident’s outstanding debt to Petitioner. Tr. 615-28. 

Under the terms of the admission agreement executed between MG and Petitioner, it is arguable that Petitioner had at least a colorable claim on all the insurance surrender proceeds of $19,131.01. If so, arguably Resident 1 had no right to the money, no right was violated, and no misappropriation was possible because the money was not Resident 1’s. However, the evidence shows that there was a modification of the admission agreement that gave Resident 1 the right to an amount of the proceeds necessary to pay for a prepaid funeral and burial contract. MG testified:

I spoke with Adriana [Petitioner’s business manager (Tr. 635)] once I obtained it [prepaid funeral and burial plan] and I informed her and she absolutely agreed, I was actually surprised she knew about it and she said yes, money goes first to the irrevocable death policy and then the rest of the funds do come to the unpaid debt.

Tr. 437. Petitioner does not dispute or attempt to rebut this testimony. Petitioner does not deny that Adriana had authority to enter this modification of the admission agreement terms. Petitioner does not assert that the modification should not be binding. I conclude that Petitioner had no claim to an amount of the insurance surrender value equal to the cost of the prepaid funeral and insurance policy based on the admission agreement as modified by its business manager and MG, i.e., $8,900 of the amount paid by Prudential upon surrender of Resident 1’s life insurance policy. Because Petitioner had no claim to $8,900 of the proceeds, that amount was Petitioner’s property not subject to the requirement of the admission agreement to pay all income of the resident to Petitioner. 

Accordingly, I conclude that Petitioner misappropriated Petitioner’s funds in the amount of $8,900 and deprived Resident 1 and his representative of the right to dispose of that money as they wished. The complaint revisit survey conducted on February 4, 2014, alleged that the violation of Tag F151 continued because Petitioner had not refunded all the money to the resident or his responsible party. CMS Ex. 41 at 3; Tr. 629. I infer that the same logic applies to noncompliance under Tag F224 cited by CMS. The plan of correction entered on the SOD indicates Petitioner had begun to refund or otherwise pay for the prepaid funeral and burial policy but had not completed that process. CMS Ex. 41 at 1 (right column of the SOD). I conclude that until an amount equal to the prepaid funeral and burial expense was returned to Resident 1 or his representative, the violation of the resident’s rights and the misappropriation continued. CMS determined that Petitioner returned to substantial compliance on March 8, 2015. Jt. Stip. ¶ 3. CMS has made a prima facie showing and Petitioner failed to rebut the CMS prima facie case by a preponderance of the evidence.

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6. Petitioner violated 42 C.F.R. § 483.13(c)(2)-(4) (Tag F225) and the violation posed a risk for more than minimal harm.

The surveyors allege in the SOD for the recertification survey completed on October 23, 2014, that Petitioner violated 42 C.F.R. § 483.13(c)(2)-(4) because it failed to report an allegation of abuse to the state agency. CMS Ex. 1 at 2.

a. Facts

Resident 395 was 85 years old at the time of the October 2014 survey. She was admitted to Petitioner on August 25, 2014, for rehabilitation from a pelvic fracture. CMS Ex. 66 at 1. A physician progress note for a visit on September 8, 2014, reports that the resident complained of increased pain in her right hip since she was dropped into bed. The note also shows that she had previously suffered an intertrochanteric fracture of the right femur that had to be surgically repaired with a nail or pin. CMS Ex. 66 at 3. Resident 395 was discharged on September 19, 2014, after completing her rehabilitation stay. CMS Ex. 66 at 6-7. 

On September 7, 2014, Resident 395 complained to Petitioner’s weekend supervisor that she was mistreated by a CNA who dropped her onto her bed. Petitioner’s grievance/complaint report shows that the compliant was reported to “DCF the Abuse hotline 800-96-abuse.” CMS Ex. 67 at 1-2. The form shows the family was notified and that x-rays were done, which were negative except for the prior hip repair. CMS Exs. 66 at 4-5; CMS Ex. 67 at 1. Therefore, there is no dispute that Resident 395 made the complaint which caused Petitioner to take some action. 

Petitioner had issued a resident abuse policy with a revision date of June 23, 2013. The policy provides that all residents are to be protected from physical or mental abuse, involuntary seclusion, neglect, or misappropriation of their property. The policy provided that all allegations were to be investigated and reported to the appropriate regulatory agency. Staff was to report to the nursing supervisor and or the Administrator. CMS Ex. 68 at 1.

The surveyors recognized that Resident 395’s allegation was reported to the Department of Children & Families (DCF). However, the surveyors cited Petitioner as noncompliant under Tag F225 because Petitioner did not report the allegation to the state agency. CMS Ex. 1 at 4.

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b. Analysis

The regulation requires:

(c) Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

* * * *

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

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

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

42 C.F.R. § 483.13(c)(2)-(4) (emphasize added). The regulation is clear that both allegations of abuse or neglect and the investigation of those allegations must be reported in accordance with state law, including to the state survey agency. There is no dispute that Petitioner reported to DCF but not the state survey agency. Accordingly, I conclude that CMS made a prima facie showing of noncompliance. I accept as credible and weighty the surveyors’ opinion that the violation posed a risk for more than minimal harm to Petitioner’s residents. 

Petitioner argues that CMS presented no competent evidence to establish the noncompliance. P. Br. at 3. Petitioner argues more specifically that the only evidence presented is “non-substantiated hearsay contained in the statement of deficiencies,” and hearsay should not be considered as a basis for finding Petitioner violated this regulation. P. Reply at 14. Petitioner does not deny the allegation that it failed to report the

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allegation by Resident 395 to the state agency. Petitioner is correct that it preserved a hearsay objection. However, hearsay is admissible in this forum. 42 C.F.R. § 498.61. The fact that evidence, whether documentary or testimonial, is hearsay is considered in weighing the evidence but the fact it is hearsay does not mean it may not be considered to be competent and substantive. In this case, I find the documents obtained from Petitioner’s files for Resident 395 to be both credible and probative. Petitioner is required to maintain clinical records on each resident in accordance with accepted professional standards and practices that are complete and accurate. 42 C.F.R. § 483.75(l). Petitioner’s clinical records recording Resident 395’s allegation are contemporaneous with the incident and reflect the action of Petitioner’s staff in response to the allegation. CMS Exs. 66 at 4-5; 67 at 1-2. Petitioner does not deny the accuracy or the veracity of the records. I conclude that Petitioner’s clinical records are credible and weighty. The fact that Petitioner does not dispute that Resident 395 made the allegation and that it was only reported to the DCF and not the state agency, corroborates Petitioner’s own records. 

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.13(c)(2)-(4) that amounted to noncompliance because it posed a risk for more than minimal harm. Petitioner has failed to meet its burden to rebut the prima facie showing by CMS.

7. Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii)(Tag F282) and the violation posed a risk for more than minimal harm. 

This Tag involves the examples of two residents, Resident 378 and Resident 379. The surveyors allege in the SOD that both residents’ care plans imposed fluid restrictions but Petitioner was unable to show that it complied with the fluid restriction. CMS Ex. 1 at 11.

a. Facts

Resident 378 was admitted to Petitioner on October 3, 2014. His diagnoses included diastolic heart failure, atrial fibrillation, chronic obstructive pulmonary disease, hypopotassemia, morbid obesity, sleep apnea, edema, and deep vein thrombosis. CMS Ex. 11 at 1-8. His physician ordered fluid restriction to 1,200 milliliters (ml) per day on October 6, 2014. CMS Ex. 11 at 9, 19. On October 7, 2014, Petitioner’s dietician implemented the fluid restriction of 1200 ml per day, specifying that nursing staff was to provide 240 ml between 7:00 p.m. and 7:00 a.m. and 240 ml between 7:00 a.m. and 7:00 p.m. and dietary was to provide 240 ml at breakfast, lunch, and dinner. The dietician’s plan specified no water pitcher at bedside, no jello, no ice cream, and no soup. CMS Ex. 11 at 39. Resident 378’s care plan dated October 7, 2014, noted the fluid restriction and required monitoring of food and fluid intake with a hand-written note specifying fluid compliance and that a total of 480 ml of fluid was to be provided by nursing and 720 ml

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by dietary. CMS Ex. 11 at 46. The percentage of fluids Resident 378 consumed at meals was recorded. On the 7:00 a.m. to 3:00 p.m. shift from October 4 through 22, 2014, it was recorded that the resident consumed 75 to 100 percent of fluids provided by dietary. During the 3:00 p.m. to 11:00 p.m. shift it was recorded that the resident consumed 75 to 100 percent of the fluids provided by dietary. CMS Ex. 11 at 23-25. The resident’s MAR lists the 240 ml to be provided by nursing during the 7:00 a.m. to 7:00 p.m. and 7:00 a.m. to 7:00 p.m. shifts with check marks and initials indicating fluids were provided and/or consumed except on the day shifts on October 8 and 14. CMS Ex. 11 at 20. 

Resident 379 was admitted to Petitioner on October 10, 2014. CMS Ex. 12 at 1-6. A dietary progress note dated October 17, 2014, indicates that he required dialysis, he tolerated fluid restriction well, he was to be monitored for signs of fluid overload, and he was to be encouraged to comply with fluid restriction. CMS Ex. 12 at 7. A nutrition assessment dated October 10, 2014, listed his diagnoses as status epilepticus (continuous state of seizure), acute encephalopathy, end-stage renal disease on hemodialysis, diabetes mellitus, hypertension, gastroesophageal reflux disease, and prostate hypertrophy, among others. Fluid restriction was listed as 1500 ml per day and 30 ml of a supplement per day. CMS Ex. 12 at 8, 10. A document titled “Fluid Restriction” dated October 13, 2014, lists fluid restriction of 1500 ml per day, with 600 ml to be provided by nursing (180 ml during the night shift and 420 ml, including 240 ml of supplement, during the day shift). The document specifies no water pitcher at bedside. The document specifies that dietary is to provide 900 ml per day (420 ml with breakfast, 240 ml with lunch, 240 with dinner) and specified that no jello, soup, or ice cream were to be provided. CMS Ex. 12 at 45. A physician order dated October 13, 2014, specified a fluid restriction of 1500 ml per day with 600 ml to provide by nursing including a supplement, and 900 ml provided by dietary. CMS Ex. 12 at 12. Resident 379’s nutritional care plan dated October 13, 2014 and revised on October 17, 2014, required fluid restriction of 1500 ml per day including 600 ml per day provided by nursing and 900 ml per day provided by dietary but did not specifically mention that the 600 ml per day provided by nursing included the supplement per day. CMS Ex. 12 at 23-24. A MAR shows that 30 ml of supplement was given at 9:00 p.m. on October 11 through 22, 2014. CMS Ex. 12 at 25, 35. The MAR also shows that “1 can” of a different supplement was provided on October 13 through 21, 2014 at 5:00 p.m. The MAR listed the fluid restriction of 1500 ml per day with 600 ml to be provided by nursing per day – 300 ml per 12-hour shift including the supplement, and 900 ml to be provided by dietary. The MAR has initials entered for the 7:00 a.m. to 7:00 p.m. shift on October 14 through 22, 2014 and lists 420 ml and the 7:00 p.m. to 7:00 a.m. shift on October 13 through 22, 2014 and lists 180 ml. CMS Ex. 12 at 28, 33. A treatment record lists the fluid restriction as 1500 ml per day and initials are entered for day and night shift on October 11, 2014 and only the morning shift on October 12 and 13, 2014. CMS Ex. 12 at 29, 39. An untitled tracking sheet for the 7:00 a.m. to 3:00 p.m. shift records that the resident consumed 75 to 100 percent of fluids provided by dietary from October 10 through 22, 2014. CMS Ex. 12 at 41-42. A tracking sheet for the 3:00 p.m. to 11:00 p.m. shift records that the resident consumed

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100 percent of fluids provided by dietary from October 10 through 23, 2014. CMS Ex. 12 at 43.

Surveyor Bailey-Dowling testified that she did the investigation related to Residents 378 and 379. Tr. 264. She testified that she observed Resident 379’s room and observed a pitcher of water on his bedside table on two consecutive days and a 16.9 ounce (500 ml) bottle of water also near his bed that had been brought to the room by the resident’s wife. Tr. 279-80, 309-10, 345. Subsequently she testified that the water bottle was full, there was also a cup of full of water, and a pitcher with ice and water. Tr. 340-41. She testified that she also observed Resident 378’s room. Tr. 282. Surveyor Bailey-Dowling’s surveyor notes state that she visited Resident 378’s room twice, she saw no water pitcher, and there was a sign that indicated he was on fluid restriction. CMS Ex. 14 at 15. She testified that Petitioner was cited because it was not possible based on Petitioner’s records to determine how much fluid each resident consumed daily. Tr. 288-89, 308, 330.

Maria Corchero, Petitioner’s registered dietician technician during the survey testified that nursing did monitor the residents’ fluid restrictions. Tr. 512-15. She explained how the order for fluid restriction is received from the physician and dietary allocates the fluids to be delivered by nursing and dietary during meals, taking into account resident preference when possible. Tr. 517-18. She agreed on cross-examination that for a resident on fluid restriction it is common to order no water pitcher at bedside. Tr. 525-26.

b. Analysis

The surveyors allege in the SOD for the survey completed on October 23, 2014, that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) because Petitioner’s staff failed to follow the care plans of Residents 378 and 379 related to fluid restrictions. CMS Ex. 1 at 11. The surveyors noted that an assistant director of nursing confirmed that nurses do not record the total amount of fluid consumed by a resident and CNAs only record the percentage of fluid consumed at mealtime. The surveyor noted that there was no sign in Resident 379’s room indicating he was on fluid restriction. The surveyors also observed that Resident 379 was in his room and had a pitcher of water and ice, a cup of water, and a 16.9 ounce bottle of water on his bedside table. CMS Ex. 1 at 11-13. Surveyor Bailey-Dowling clarified during her testimony that Petitioner was cited because it was not possible to determine how much fluid each resident was consuming each day. Tr. 288-89, 308, 330. 

The regulation cited by the surveyors requires:

(3) The services provided or arranged by the facility must—

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* * * *

(ii) Be provided by qualified persons in accordance with each resident’s written plan of care.

42 C.F.R. § 483.20(k)(3). There is no issue raised by the surveyors under this deficiency citation about the qualification of Petitioner’s staff. The issue raised is whether Petitioner’s staff complied with the care plan for fluid restrictions for each resident.

The concern expressed by Surveyor Bailey-Dowling about recording fluid intake does not reflect a regulatory violation or noncompliance in this case. The records of both Resident 378 and Resident 379 show that staff did monitor fluid intake by each resident. Staff did not measure the actual number of milliliters consumed each time fluid was offered to a resident, but nursing staff did record that fluid was offered and/or consumed on the MAR and the CNAs recorded the percentage of fluid consumed by each resident at each meal. Simple math calculations yield the quantity of fluid offered and or consumed throughout the day. CMS does not dictate how long-term care facilities are required to document fluid intake. I conclude that the method Petitioner’s staff used to record fluid consumption by each resident did not violate the resident’s care plans or constitute a violation of 42 C.F.R. § 483.20(k)(3)(ii). 

The surveyors also noted in the SOD that Petitioner did not have a sign posted in each resident’s room indicating that they were on fluid restriction. Neither resident’s care plans required the posting of a sign in their rooms indicating that they were on fluid restrictions. A requirement to post information regarding diagnoses and or treatment approaches where publicly visible must be weighed carefully against protecting resident privacy and dignity interests. Further, the consistent recording by nursing and CNA staff of the offer and/or consumption of fluids supports an inference that staff were aware of the resident’s fluid restrictions and the addition of a sign would have limited utility outweighed resident privacy/dignity interests. 

I find based on the evidence before me that it is more likely than not that Resident 378’s care plan related to fluid restrictions was followed by Petitioner’s staff. The surveyors record no observations that support a finding of a violation of Resident 378’s care plan, except the concern about how staff recorded fluid consumption. CMS Ex. 1 at 12. Surveyor Bailey-Dowling did not identify any specific failure to follow the requirements of Resident 378’s care plan in either her testimony or surveyor notes except the method of recording fluid consumption. Tr. 282; CMS Ex. 14 at 15.

The example of Resident 379 does show a violation of the resident’s care plan and the regulatory requirement for staff to follow the care plan. Surveyor Bailey-Dowling provided unrebutted testimony that, as alleged in the SOD (CMS Ex. 1 at 12), she observed on two consecutive days a pitcher of water and a cup of water on Resident

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379’s bedside table and a 16.9 ounce bottle of water on at least one day. Tr. 279-80, 309-10, 345. Petitioner does not deny that the pitcher and cup with water were present in the resident’s room on the bedside table two consecutive days or show that it had any way to track any consumption of fluids from those vessels by the resident. P. Br. at 9; P. Reply at 9-10. Petitioner’s dietician specifically stated in the “Fluid Restriction” worksheet that Resident 379 was to have no water pitcher at bedside. CMS Ex. 12 at 45. The prohibition on having a water pitcher at bedside is not specifically listed in the document title “Nutritional Status Care Plan” but that omission is not accepted as excusing Petitioner from compliance with the resident’s fluid restrictions as specified by the resident’s physician and applied by Petitioner’s dietician. I conclude that CMS has made a prima facie showing that Petitioner’s staff failed to comply with Resident 379’s care plan by allowing a water pitcher containing water to be present at the resident’s bedside. Petitioner has not shown by a preponderance of the evidence that Resident 379 did not consume water from the sources in his room or that the water in his room was actually part of or within the resident’s ordered fluid restriction. I find that the evidence shows the failure to ensure that the resident’s care planned fluid restrictions were followed placed the resident at risk for more than minimal harm, as evidenced by physician orders imposing the fluid restrictions, the implementation of fluid restrictions by the interdisciplinary team, and the opinions of the surveyor reflected in the SOD that the violation posed a risk for more than minimal harm. 

I conclude that CMS has made prima facie showing of a violation of 42 C.F.R. § 483.20(k)(3)(ii) that posed a risk for more than minimal harm and Petitioner has failed to rebut the prima facie showing. Accordingly, Petitioner was not in substantial compliance with the requirement of 42 C.F.R. § 483.20(k)(3)(ii).

8. Petitioner did not violate 42 C.F.R. § 483.55(a) (Tag F411).

a. Facts

Resident 380 was admitted to Petitioner on October 10, 2014. His diagnoses included swelling of a limb secondary to cellulitis with pain and he had a pacemaker and hypertension. CMS Ex. 13 at 1, 4, 19, 20, 25; P. Ex. 26. On October 20, 2014, a physician ordered Orajel™ for a complaint of toothache and a pureed diet. CMS Ex. 13 at 21. Resident 380’s Interdisciplinary Care Plan was updated on October 20, 2014, to require Orajel™ as necessary for toothaches. CMS Ex. 13 at 27. 

Petitioner placed in evidence a progress note dated October 20, 2014, prepared by a physician assistant (PA). The progress note shows that Resident 380 complained of toothache pain during his follow-up visit for cellulitis. The PA ordered Orajel™ be applied to the affected tooth and the resident would follow-up with a dentist as an outpatient when his therapies at Petitioner were complete. The PA noted that Resident 380 agreed with the plan. P. Ex. 26 at 1-2. A second PA progress note dated October 24,

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2014, also noted toothache and ordered that Orajel™ be continued with follow-up as an outpatient. P. Ex. 26 at 3. CMS did not object to the authenticity of P. Ex. 26 and I find no reason to doubt the credibility of this medical record. 

Surveyor Bailey-Downing interviewed Resident 380 during the survey. She testified that she observed him on two consecutive days, October 22 and October 23, 2014, eating his pureed breakfast and he complained of pain with his teeth. He told her that he had broken teeth and would like to have them fixed so that he could return to a regular diet. She testified that he told her that he had told Petitioner’s staff he would like to see a dentist but was told he could not until he was discharged from Petitioner. She testified that P. Ex. 26, the PA progress notes, were not given to her during the survey which caused her some concern about its reliability given the complaints of the resident. Tr. 290-303.

b. Analysis

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.55 because it failed to assist Resident 380 obtain dental services. CMS Ex. 1 at 26-27. The evidence shows that Resident 380 complained of toothache on October 20, 2014, to a PA during an examination. Orajel™ was ordered with a pureed diet. The PA’s note indicates that Resident 380 agreed that he could see a dentist after his discharge from Petitioner. The PA saw Resident 380 a second time, toothache was again noted, but the PA did not make any change to the plan to use Orajel™ and see a dentist after the discharge. Based on these facts, I find that Petitioner was not required to obtain dental services for Resident 380. Resident 380 was seen by the PA and there was a plan to address his complaint of toothache. Petitioner’s staff is not obligated to second guess the plan developed by the PA or arrange for dental services despite the plan. Accordingly, I conclude that there was no violation of 42 C.F.R. § 483.55.

9. Petitioner violated 42 C.F.R. § 483.60(d)19 (Tag F431) and the violation posed a risk for more than minimal harm.

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The regulation requires that drugs and biologicals used in a facility be “labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable. 42 C.F.R. § 483.60(d). The surveyors allege in the SOD for the October 2014 survey that Petitioner failed to ensure eye medication was dated when opened on two of seven medication carts. CMS Ex. 1 at 36. Specifically, the surveyors allege that they found three bottles of prescription eye medications (Pataday, Vigamox, and Atropine) that were opened but undated. The surveyors allege that when they pointed out that the bottles were open but not dated, staff immediately wrote a date on the bottles. CMS Ex. 1 at 36-37. 

The revisit survey completed February 4, 2015, found that Petitioner failed to return to substantial compliance with 42 C.F.R. § 483.60(d) because Petitioner failed to ensure expired medications were not used. CMS Ex. 2 at 2. During the revisit survey the surveyors allege they found a bottle of Vitamin B12 that expired in December 2014, a bottle of Calcium plus Vitamin D that expired January 2015, and two bottles of oyster shell calcium plus Vitamin D that expired in January 2015. CMS Ex. 2 at 2-3. The surveyors allege that Petitioner had a policy that required that the medication cart be checked daily by the nurse before starting the shift, expiration dates are to be checked prior to administration; and for over-the-counter medication the expiration date is to be circled on the container upon opening. CMS Ex. 2 at 4. 

Petitioner does not deny that during the October 2014 survey surveyors found some opened bottles of eye drops that were not dated when opened, except for a bottle of atropine. Petitioner argues that CMS failed to make a prima facie showing because CMS failed to show any currently accepted professional principles that require dating a container of eye medication when the container is opened. P. Br. at 18. 

Petitioner offered the testimony of two of its LPNs who were responsible for medication carts during the October 2014 survey. LPN Love testified that it was Petitioner’s policy and procedure for staff to write the date the medication was opened and when it expired on the container. Tr. 569-70, 575-76. LPN Clark testified that she cut the plastic wrapper off a bottle of atropine but she did not date it prior to the surveyor discovering it because she did not actually open the bottle. LPN Clark testified that it was the practice of Petitioner’s staff to write a date on an eye medication container when the container was first opened because the medication needed to be discarded no more than 28 days

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after opening. She explained that because she only removed the wrapper and did not actually open the medication container, she did not date the container until the surveyor implied that she should do so. Tr. 592-94, 597-99, 601-609. CMS incorrectly asserts that LPN Clarke testified that it was standard nursing practice to discard eye medication 28 days after it was opened. CMS Br. at 34. However, LPN Clarke made no statement that disposal after 28 days was standard nursing practice only that placing a date on the medication container on opening was Petitioner’s policy. In its post-hearing reply, CMS again argues that LPN Clarke testified that it is standard nursing practice to discard eye medications 28 days from opening. CMS apparently recognized in its reply brief that it must show as an element of its prima facie case that there are professional principles that establish the standard with which Petitioner must comply. CMS urges me to accept LPN Clarke’s testimony and statements made to surveyors during the survey that it was Petitioner’s policy to write a date on an eye medication container when it was opened as the evidence CMS needs of a professional principle. CMS Reply at 25-26.

In Hillman Rehabilitation Center, the Board described the elements of the CMS prima facie case in general terms as follows:

HCFA [now known as CMS] must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA’s findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA’s evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8.  In the final Hillman decision after remand, the Board explained:

The ALJ should be able to determine the existence of a prima facie case at the close of HCFA’s presentation. Hence, as we pointed out in our first decision, HCFA would lose even if the provider offered no evidence at all, if HCFA did not come forward with evidence sufficient to support a conclusion in its favor in presenting its prima facie case. Thus, we held that HCFA must make its case “at the outset.”

Once HCFA has established a prima facie case, the provider may then offer evidence in rebuttal, both by attacking the factual underpinnings on which HCFA relied and by offering evidence in support of its own affirmative arguments. An effective rebuttal of HCFA’s prima facie case would mean that at the close of the evidence the provider had shown that

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the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence.

* * * *

The major purpose of requiring HCFA to establish a prima facie case is to assure that the action taken by HCFA has a legally sufficient foundation, if the facts are determined to be as alleged by HCFA (since it would be unfair and inefficient to require a provider to defend against a case that, even if proven, would not suffice to support the action taken). In addition, we concluded that fairness requires HCFA to set out evidence of the factual basis for its action in order that the provider not have to offer a shot-gun defense without adequate notice to respond to the case against it. These purposes are accomplished once HCFA has presented a case sufficient, if not effectively rebutted, to sustain its action. At that point, HCFA has established a prima facie case and, to prevail, the provider must proceed to prove its case by the preponderance of the evidence on the record as a whole.

Hillman, DAB No. 1663 (internal citations omitted). 

I conclude that CMS did not make a prima facie showing of a violation of 42 C.F.R. § 483.60(d) based on the absence of dates being written on some open bottles of eye medication because CMS failed to present evidence of the standard to which it seeks to hold Petitioner. The regulation requires that drugs and biologicals used in a facility be “labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.” 42 C.F.R. § 483.60(d). CMS failed in this case to understand the meaning of “professional principles” as established by its own policy set forth in the SOM. Therefore, CMS failed to present evidence of the applicable professional principle.

The SOM in effect at the time of the survey in the section discussing labelling of medications and biologicals states:

This section requires facility compliance with currently accepted labeling requirements, even though the pharmacies are responsible for the actual labeling. Labeling of medications and biologicals dispensed by the pharmacy must be consistent with applicable federal and State requirements and currently accepted pharmaceutical

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principles and practices. Although medication delivery systems may vary, the medication label at a minimum includes the medication name (generic and/or brand) and strength, the expiration date when applicable, and typically includes the resident’s name, route of administration, appropriate instructions and precautions (such as shake well, with meals, do not crush, special storage instructions).

SOM Tag F431 (rev. 22, Dec. 18, 2006).20 This explanation clearly shows that the regulatory focus is upon “currently accepted pharmaceutical principles and practices” rather that long-term care industry principles and practices or standard nursing practice as CMS argues. It also sets a minimum level of information for substantial compliance including the medication name, strength, expiration date, resident name, route of administration, appropriate instructions and precautions. The focus of the regulation and the SOM in effect at the time of the survey was on the information provided by the pharmacist or manufacturer, not some information nursing staff at a long-term care facility may add to the medication container. 

The SOM provides under the section titled “Criteria for Compliance” that a facility is in compliance if it meets certain conditions, specifically with regard to labeling:

Medication labeling identifies, at a minimum, the medication’s name, strength, expiration date when applicable, and lot number, and provides instructions as necessary for safe administration.

SOM Tag F431 (rev. 22, eff. Dec. 18, 2006).

CMS offered no evidence of currently accepted pharmaceutical principles and practices that require that Petitioner’s staff place a date on a container of eye medication upon opening. Accordingly, CMS failed to present evidence of a key element of 42 C.F.R. § 483.60(d) and failed to make a prima facie showing that Petitioner violated that regulation.

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Regarding the revisit survey, Petitioner does not deny that the surveyors found vitamins and supplements that had expired as alleged by the surveyors. Rather, Petitioner argues regarding the findings of the revisit survey that CMS failed to make a prima facie showing as it has not shown that vitamins and supplements are drugs or biologicals subject to 42 C.F.R. § 483.60(d) (Tag F431). Petitioner cites P. Ex. 29 and argues that the U.S. Food and Drug Administration (FDA) does not describe vitamins and supplements as drugs or biologicals. P. Br. at 25-28; P. Reply at 12-13. Petitioner’s reliance on the FDA is misplaced as CMS specifically addressed vitamins and supplements and includes them among the substances subject to the regulations governing a long-term care facility’s responsibilities for drugs and biologicals. Although the regulations may not provide the definitions Petitioner seeks, the SOM in effect at the time of the surveys lists vitamins, minerals, amino acids and herbs as “dietary supplements.” SOM Tag F325, 42 C.F.R. § 483.25(i) (rev. 36, eff. Aug. 1, 2008). The SOM also treats failure to administer vitamins as a medication error. SOM Tag F332 and F333, 42 C.F.R. § 483.25(m) (rev. 70, eff. Jan. 7, 2011); SOM Tag F428, 42 C.F.R. § 483.60(c) (rev. 22, eff. Dec. 18, 2006). 

I conclude that Petitioner was not in substantial compliance with program requirements because it failed to ensure that medication carts did not contain expired vitamins and supplements. Petitioner violated 42 C.F.R. § 483.60(d) and did not meet its burden to rebut the surveyor’s opinions in the SOD and testimony or to show that there was no risk for more than minimal harm due to the presence of expired vitamins. 

10. Petitioner violated 42 C.F.R. § 483.70(c)(2) (Tag F456) and the violation posed a risk for more than minimal harm.

The regulation requires that Petitioner ‘[m]aintain all essential mechanical, electrical, and patient care equipment in safe operating condition.” 42 C.F.R. § 483.70(c)(2). The surveyors alleged in the SOD for the survey ending October 23, 2014, that Petitioner failed to maintain essential patient care equipment in safe operating condition. CMS Ex. 1 at 37. The surveyors allege more specifically that Petitioner failed to ensure three suction machines on crash carts were maintained to ensure that they were safe to operate because they had no current preventive maintenance dates posted on them; and Petitioner failed to ensure that one suction machine on a crash cart was clean.

Petitioner asserts CMS failed to make a prima facie showing regarding this alleged noncompliance because the record contains no competent evidence of a regulatory violation. P. Br. at 20. Petitioner did not elaborate on the assertion that there is no competent evidence in the record. However, Petitioner certainly must recognize that both the SOD (CMS Ex. 1 at 37-38) and the surveyors’ investigative notes (CMS Ex. 14 at 31-32) are evidence. Although both the SOD and surveyor notes are hearsay, they are nevertheless admissible in this proceeding and subject to being weighed with other evidence related to the deficiency. In this instance, Petitioner does not specifically deny

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the factual allegations of the surveyors or offer any evidence to outweigh or rebut the evidence. 

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.70(c)(2). The surveyors’ unrebutted assessment of the violation was that it posed a risk for more than minimal harm to Petitioner’s residents and, therefore, amounted to noncompliance under Tag F456. Petitioner has failed to show by a preponderance of the evidence that it maintained substantial compliance under Tag F456. 

11. Petitioner violated 42 C.F.R. § 483.75(l)(1) (Tag F514) and the violation posed a risk for more than minimal harm.

The surveyors who completed the revisit survey that concluded on February 4, 2015, allege that Petitioner violated 42 C.F.R. § 483.75(l)(1). The surveyors cite the examples of two residents, Resident 74 and Resident 516, alleging that there were inconsistencies as to physician telephone orders and various clinical records for the residents. CMS Ex. 2 at 4-5. 

Examination of the example of Resident 516 is sufficient to show that Petitioner was noncompliant under Tag F514.

a. Facts

Resident 516 was admitted to Petitioner originally on October 9, 2010 and readmitted in January 2015. Her diagnoses included diabetes with complications. CMS Ex. 37 at 1-2.

A physician’s order dated January 31, 2015, ordered that the resident be given 1 milligram of glucagon as necessary for blood sugar less than 60 and to change the resident’s sliding scale insulin to a medium dose. CMS Ex. 37 at 5. A physician order sheet for the period February 1 through 28, 2015, states that the resident should receive no insulin for blood sugar up to 150, no insulin for blood sugar from 151 to 200, three units for blood sugar from 201 to 250, four units of insulin for blood sugar from 251 to 300, six units of insulin for blood sugar from 301 to 350, nine units for blood sugar from 351 to 400, and if greater than 400 administer nine units and call the physician. CMS Ex. 37 at 6. The sliding scale on the physician order sheet matches the low dose sliding scale listed in CMS Ex. 37 at 4. “Three Medication Records,” the dates on which are unreadable, also list the low dose sliding scale, but hand-written notes state “see glucose log.” CMS Ex. 37 at 9-11. Two “Blood Glucose Monitoring Log” sheets for February 2015, show that Resident 516 was on a sliding scale characterized as a medium insulin dose. CMS Ex. 37 at 2-3. An undated and unsigned “Insulin Sliding Scale Protocol for Diabetic Patients” indicates that Resident 516 was on a low dose insulin regimen, but it is not clear when this document was prepared. CMS Ex. 37 at 4.

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b. Analysis

The regulation requires:

The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices that are—

(i) Complete;

(ii) Accurately documented;

(iii) Readily accessible; and

(iv) Systematically organized.

42 C.F.R. § 483.75(l)(1).

It is clear that the clinical records for Resident 516 offered for my consideration are inconsistent. The physician order clearly states Resident 516 is supposed to be on a medium dose sliding scale in February 2015. CMS Ex. 37 at 5. However, the physician order sheet for February 2015 lists ranges and amounts of insulin consistent with a low dose insulin sliding scale. CMS Ex. 37. The Medication Records are not weighty as it is impossible to determine with any certainty the period to which they apply. CMS Ex. 37 at 9-11. The Insulin Sliding Scale Protocol for Diabetic Patients is also not weighty as it has no date. CMS Ex. 37 at 4. Petitioner argues that the Medication Records instruct staff to use the glucose log. The Blood Glucose Monitoring Log for February 2015 does refer to a medium dose. CMS Ex. 37 at 2. 

Petitioner does not deny the inconsistencies in Resident 516’s records regarding how much insulin the resident was to receive. However, Petitioner suggests it was adequate for the Medication Records to instruct staff to use the Blood Glucose Log. P. Br. at 29-30; P. Reply at 11-12.

The regulatory requirement is clear that Petitioner’s clinical records for each resident must be complete and accurate. Petitioner’s records for Resident 516 were not complete, were inconsistent, and not accurate. Petitioner asserts that there is no evidence a resident received the wrong dose of insulin based on the inconsistent records. P. Br. at 29. However, it is not necessary for CMS to show or me to find that any resident was actually harmed by Petitioner’s incomplete and inaccurate records. The surveyors allege in the SOD that this deficiency posed a risk for more than minimal harm. CMS Ex. 2 at 4. The surveyors’ findings are unrebutted. 

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.75(l)(1), the violation posed a risk for more than minimal harm and amounted to noncompliance under Tag F514.

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12. A CMP of $350 per day from January 8, 2014 through November 22, 2014; a CMP of $150 per day from November 23, 2014 through March 7, 2015; and a DPNA from January 6, 2015 through March 7, 2015, are reasonable enforcement remedies.

I have concluded that Petitioner was not in substantial compliance with several participation requirements based on the surveys in this case. Therefore, CMS has bases to impose enforcement remedies. 

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose a per-day CMP for the number of days that the facility is not in compliance or a per-instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy. 42 C.F.R. § 488.430(a). The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMPs, $50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy but either cause actual harm to residents or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). Immediate jeopardy was not cited in this case and the lower range of CMPs authorized is applicable. 

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e). The limitations are: (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount. In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor. The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual

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harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread. My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me. I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose but my authority is limited by regulation as already explained. I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations. Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997). 

CMS proposed the following enforcement remedies based on noncompliance for the surveys under review: a CMP of $350 per day from January 8, 2014 through November 22, 2014; a CMP of $150 per day from November 23, 2014, through March 7, 2015; and a DPNA effective January 6, 2015 through March 7, 2015.

The $350 and $150 per-day CMPs that CMS proposed are at the low end of the lower range of CMPs authorized. Petitioner has a history of noncompliance dating back to 2004, with 19 surveys citing noncompliance, repeat noncompliance under Tags F282 and F456, and enforcement remedies imposed based on 3 surveys. Resident 113 suffered actual harm due to recurring tooth pain. I also conclude that Petitioner was culpable as to each instance of noncompliance particularly with regard to the duration of the noncompliance involving Resident 113 and the handling of the surrender of Resident 1’s life insurance policy. All but one of the allegations of noncompliance were alleged to be isolated deficiencies. CMS Exs. 1, 2, 40, 41. I have received no evidence to consider related to Petitioner’s financial condition. I conclude that the per-day CMPs proposed CMS are reasonable. 

In arguing that the remedies imposed are unreasonable, Petitioner first relies on its prior arguments that CMS failed to establish a prima facie case for the deficiencies cited and that Petitioner was otherwise in substantial compliance with program requirements during the relevant dates. P. Br. at 32. However, CMS established a prima facie case for the alleged noncompliance and Petitioner failed to offer sufficient evidence to rebut the prima facie case. 

Petitioner further points out that Petitioner had a minimal enforcement history with 19 survey cycles dating from November 2004 through April 2014, during which no deficiencies cited exceeded the scope and severity of an F-level deficiency. P. Br. at 31. In 16 of 19 survey cycles, CMS did not impose any remedies for those citations. P. Br. at 31. Petitioner also points out that most of the deficiencies in this survey were cited as isolated deficiencies. P. Br. at 31. I have considered Petitioner’s enforcement history and I conclude that even as characterized by Petitioner, no reduction in the proposed CMPs is required.

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Finally, Petitioner argues that the CMP dating back to January 8, 2014 is unreasonable. Petitioner argues that Resident 113 was examined by a dentist on January 8, 2014. Petitioner asserts that there is no evidence Resident 113 or any other resident was in any pain or that any actual harm to any resident occurred. P. Br. at 31-32. Petitioner’s argument that the CMP dating back to January 8, 2014 is unreasonable is without merit. A CMP may be imposed for all the days of past noncompliance since the last standard/recertification survey. 42 C.F.R. § 488.430(b). Petitioner’s last standard recertification survey concluded on October 31, 2013. CMS Ex. 8 at 1. A per day CMP may accrue from the date the facility was first out of substantial compliance until the date it is determined to have achieved substantial compliance. 42 C.F.R. § 488.440(a)(1), (b); Avalon Place-Trinity, DAB No. 2819 at 2 (2017). Contrary to the Petitioner’s argument, the evidence in this case shows that Resident 113 complained of pain in her mouth before January 8, 2014, which is what prompted the dental consultation on that date. CMS Ex. 9 at 24; CMS Ex. 64 at 3; P. Ex. 9 at 2. I conclude that it is not unreasonable for the CMP to date back to January 8, 2014, the date when the resident was assessed and the date when the resident first received recommendations for tooth extractions. As noted above, even though the resident’s appointment for the dental extraction was canceled by the resident’s family, there was no evidence showing that the facility made good faith attempts to reschedule the tooth extractions appointment until after the survey, which was over nine months later.

I conclude based on the authorized factors that the per day CMPs proposed by CMS are reasonable enforcement remedies. Petitioner has not shown by a preponderance of the evidence that it returned to substantial compliance before March 8, 2015. I also conclude that CMS was authorized to impose a DPNA beginning January 6, 2015 through March 7, 2015, and that the DPNA is a reasonable enforcement remedy. 

III. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from January 8, 2014 through March 7, 2015. I also conclude that the following are reasonable enforcement remedies: a CMP of $350 per day from January 8, 2014 through November 22, 2014, a CMP of $150 per day from November 23, 2014, through March 7, 2015; and a DPNA effective January 6, 2015 through March 7, 2015.

• 1. The letter actually advised Petitioner that the DPNA ran from January 6, 2015 through March 7, “2014,” which is a scrivener’s error.
• 2. CMS exchanged CMS Exs. 40, 53, and 72 and subsequently exchanged substituted or corrected copies of CMS Exs. 40, 53, and 72.  Only the corrected or substituted versions were offered and admitted as evidence at the hearing.
• 3. References are to the 2014 revision of the Code of Federal Regulations (C.F.R.), unless otherwise indicated.
• 4. I recognize that due to the very low burden imposed upon CMS to make a prima facie showing, CMS has little incentive to call any witnesses to testify.  Because Petitioner has the heavier burden of showing by a preponderance of the evidence that it was in substantial compliance, usually the Petitioner is obliged to subpoena witnesses.  However, that analysis should not be used to justify the admission of unsworn testimony contrary to the requirement of 42 C.F.R. § 498.62.  Counsel for CMS had more than sufficient time to prepare a declaration or affidavit for Dr. Lemus to execute in advance of hearing to clarify her notes and authenticate and explain the x-rays, but CMS failed to do so.
• 5. Petitioner did not number the pages in its post-hearing brief and post-hearing reply brief.  In this decision, citations to page numbers for Petitioner’s briefs are to the Adobe® document reader page number.
• 6. Credible evidence’ is evidence that is worthy of belief.  Black’s Law Dictionary 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  Id. at 16.
• 7. A second revisit survey concluded on March 23, 2015, found Petitioner returned to substantial compliance on March 8, 2015.  CMS Ex. 7.
• 8. This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (http://www.cms.hhs.gov/Manuals/IOM/list.asp).  The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, she may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
• 9. CMS and the state agency use scope and severity levels when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, Chap. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
• 10. Subsection 42 C.F.R. § 483.13(c)(1)(ii) and (iii) prohibit Petitioner from hiring individuals found guilty by a court of abusing, neglecting or mistreating a resident; and require reporting to the state nurse aide registry and licensing authorities any knowledge of court action against an employee that would indicate unfitness for service as a nurse aide or facility staff.  The facts alleged in this case do not implicate these regulatory provisions and they are not addressed further.
• 11. CMS presented evidence that shows between July 1, 2013 and December 21, 2014, none of the seven MDS assessments completed by Petitioner’s staff reported a dental problem for Resident 113.  CMS Ex. 10.
• 12. Petitioner concedes that the x-rays were taken in October 2014 and they show Resident 113 had broken and decayed teeth at that time.  Petitioner argues that prior to the x-rays there is no evidence the resident had broken and decayed teeth.  P. Reply at 3.  However, Petitioner does not deny that two different dentists who saw the resident in January 2014 and April 2014 assessed her lower teeth as hopeless or not restorable and recommended or ordered extractions.
• 13. The surveyors also cite under Tag F309 the examples of Residents 378, 379, and 380.  However, the example of Resident 113 alone establishes the violation and discussion of the other examples is not necessary.
• 14. The surveyors alleged that Resident 113 actually suffered “significant” pain and that the pain affected her ability to chew food.  The significance of pain is largely subjective in the mind of the sufferer but, more importantly, it is not necessary to determine Resident 113’s degree of pain for purposes of this deficiency citation.  Further, whether or not her ability to chew observed by Surveyor Walker was due to tooth pain, the sore in her mouth or simply the limited number of her lower teeth cannot be determined on this record.  However, the source of discomfort observed by Surveyor Walker also need not be resolved.
• 15. Based upon my review of all the evidence, I find that this stipulation of fact is in error.  In fact, Petitioner did not deposit the check in “Petitioner’s bank account” but rather in Resident 1’s personal needs or trust account as provided for by the admission agreement the resident’s representative signed at the time the resident entered Petitioner.  CMS Ex. 45 at 3.  Although resident trust accounts may have been held in a bank account established by Petitioner, there is no evidence and no allegation that Petitioner improperly commingled Resident 1’s funds with Petitioner’s.
• 16. Petitioner’s Administrator testified that one of Petitioner’s business office managers was named Adriana.  Tr. 635.
• 17. The first indication that CMS was going to pursue the new charge was in the prehearing brief CMS filed in C-15-2441 on November 16, 2015.  CMS Prehearing Brief at 9 n.6.  The prehearing brief was filed before the reopened and revised determination was issued by CMS.  The colloquy with counsel for CMS during the hearing was intended to encourage counsel to proceed cautiously when adding allegations of noncompliance without clear evidence that CMS intended to cite and proceed on such an allegation or the factual basis for alleged noncompliance.  Tr. 583-86.  In this case, counsel for CMS attempted to charge and give notice of the charge in its prehearing brief at a point in the proceedings when there was no evidence CMS intended to reopen and revise its initial determination to add the allegation of noncompliance.  Under the American Bar Association Model Code of Professional Responsibility Rule 3.1, and many state bar codes of conduct, a lawyer must not assert or controvert an issue, unless there is a basis in law and fact for doing so.  Because CMS did issue the notice of reopened and revised determination, the discussion with counsel for CMS has no impact on the outcome in this case.
• 18. Counsel for CMS made various statements during the hearing and in post-hearing briefing (e.g. CMS Br. at 21-24) that may be construed to be assertions that the admission agreement was akin to a contract of adhesion and violated public policy.  No violation of 42 C.F.R. § 483.10(c) was cited by CMS or the surveyors.  CMS has offered no evidence that the admission agreement is significantly different from such agreements used by other providers, that MG was prevented from altering the agreement, that signing the admission agreement was a condition precedent to admission, or that Petitioner denied Resident 1 or his representative the right manage their own funds.  CMS offered no evidence from which it can be determined that the admission agreement was an impermissible business practice or amounted to a contract of adhesion.  Absent fact or law, this particular argument verges on being frivolous and does not merit further consideration.
• 19. The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.60(b) and (e).  Subsection (b) requires that Petitioner employ or obtain the services of a licensed pharmacist who performs services specified in that subsection.  Subsection (e) requires that Petitioner store all drugs and biologicals in locked compartments under proper temperature control and ensure only authorized personnel have access to the keys.  The SOD does not allege that Petitioner did not secure the services of a licensed pharmacist to provide the required services or that Petitioner did not ensure that secure and temperature controlled storage was used.  Therefore, no violation of 42 C.F.R. § 483.60(b) and (e) is actually alleged by the surveyors or CMS and those subsections require no further discussion.
• 20. This language is retained in the current SOM provision at SOM Tag F761 (rev. 173, eff. Nov. 22, 2017).  The current version of the SOM only requires that staff place the date on a multiuse vial when it is first accessed so that it may be discarded within 28 days unless the manufacturer specifies a different period for use after the vial is first accessed.  The drafters choice of terms recognizes a difference between first access by puncturing the membrane of the vial with a needle and removing the protective packaging.