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                              Palo Pinto Nursing Center, DAB CR5645 (2020)
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Palo Pinto Nursing Center, DAB CR5645 (2020)








  
  
    

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





Palo Pinto Nursing Center,
	(CCN: 455961),
	Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-18-269Decision No. CR5645July 7, 2020

        
              
    

      DECISION
Petitioner, Palo Pinto Nursing Center, is a long-term care facility, located in Mineral Wells, Texas, that participates in the Medicare program.  Following surveys completed on September 22, 2017 (complaint investigation), September 27, 2017 (Life Safety Code survey), and September 30, 2017 (recertification survey), the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with multiple Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS has imposed civil money penalties (CMPs) of $12,249 per day for one day of immediate jeopardy and $3,760 per day for 22 days of substantial noncompliance that did not pose immediate jeopardy.
Petitioner has appealed.  CMS moves for summary judgment, which Petitioner opposes.
For the reasons set forth below, I grant CMS’s motion.  The undisputed evidence establishes that the facility was not in substantial compliance with multiple program requirements, that its deficiencies posed immediate jeopardy to resident health and safety, and that the penalties imposed are reasonable.
Page 2
Background
The Social Security Act (Act) sets forth requirements for nursing facilities participating in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.1
  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.
The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).
**The September 22, 2017** **complaint investigation**.  In this case, local police alerted the Texas Department of Aging and Disability Services (state agency) that they had discovered, in the home of a facility nurse (later identified as LVN A), a stash of narcotics and other drugs prescribed for facility residents.  CMS Ex. 13.  Responding to the police complaint, surveyors from the state agency went to the facility to investigate.  They completed their investigation on September 22.  Based on their findings, CMS determined that the facility was not in substantial compliance with **42 C.F.R. § 483.45 (h)(1) and (2)** (Tag F431) (pharmacy services – storage of drugs and biologicals), cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm).  CMS Ex. 1 at 1; CMS Ex. 4.2
**September 27, 2017 (annual recertification survey:  Life Safety Code)**.  A facility must meet the provisions of the Life Safety Code (LSC) of the National Fire Protection Association (NFPA).  42 C.F.R. § 483.90(a)(1).  As part of the facility’s annual
Page 3
recertification, state agency surveyors completed a Life Safety Code survey on September 27.  Based on the LSC findings, CMS determined that the facility was not in substantial compliance with **42 C.F.R. § 483.90(a)** and **NFPA 25** (Tag K353) (sprinkler system – maintenance and testing), cited at scope and severity level F.  *See* LSC §§ 9.7.5, 9.7.7, and 9.7.8.  CMS Ex. 1 at 1; CMS Exs. 3, 17.3
**September 30, 2017 (annual recertification survey:  health)**.  Surveyors completed the facility’s recertification survey on September 30.  Based on their findings, CMS determined that the facility did not substantially comply with multiple additional program requirements:
42 C.F.R. § 483.12(b)(1)-(3) (Tag F224) (freedom from abuse, neglect, and exploitation – develop and implement policies and procedures) cited at scope and severity level K (pattern of substantial noncompliance that poses immediate jeopardy to resident health and safety);
	42 C.F.R. §§ 483.12(b)(1)-(3) and 483.95(c)(1)-(3) (Tag F226) (policies and training to prevent abuse, neglect, and exploitation) cited at scope and severity level K;
	42 C.F.R. §§ 483.24, 483.25, and 483.25(k), (*1*) (Tag F309) (quality of life; quality of care –pain management, dialysis) cited at scope and severity level K;
	42 C.F.R. § 483.45(f)(2) (Tag F333) (pharmacy – medication errors) cited at scope and severity level K; and
	42 C.F.R. § 483.60(i)(1)-(3) (Tag F371) (dietary services – dietary services:  food safety) cited at scope and severity level F.CMS Ex. 1 at 1; CMS Ex. 2.4
Page 4
Based on the survey findings, CMS determined that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS Ex. 1 at 1, 13.
CMS subsequently determined that the facility returned to substantial compliance on October 13, 2017.  CMS Ex. 1 at 13.
CMS has imposed civil money penalties of $12,249 per day for one day of immediate jeopardy (September 20, 2017) and $3,760 per day for 22 days of substantial noncompliance that did not pose immediate jeopardy (September 21 through October 12, 2017), for a total penalty of $94,969.  ($12,249 + $82,720 = $94,969).  CMS Ex. 1 at 13.
Petitioner appeals.  The parties have filed pre-hearing briefs (CMS Br.; P. Br.).  CMS has submitted 20 exhibits (CMS Exs. 1-20), and Petitioner has submitted nine exhibits (P. Exs. 1-9).  CMS has moved for summary judgment (CMS MSJ), which Petitioner opposes (P. Response).
Issues
As a threshold matter, I consider whether summary judgment is appropriate.
On the merits, the issues are:
1.  From September 20 through October 12, 2017, was the facility in substantial compliance with Medicare program requirements; and
2.  If, on September 20, 2017, the facility was not in substantial compliance with Medicare program requirements, did its deficiencies then pose immediate jeopardy to resident health and safety; and
3.  If the facility was not in substantial compliance with Medicare program requirements, are the penalties imposed – $12,249 per day for one day and $3,760 per day for 22 days – reasonable?
Discussion
**Summary judgment**.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing and Rehab.*, DAB No. 2539 at 3 (2013) (citing*Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986)); *Ill. Knights Templar Home*, DAB No. 2274 at 3-4 (2009), and cases cited therein.
Page 5
The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  *Livingston Care Ctr. v. Dep’t of Health & Human Servs.,*388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex Corp. v. Catrett*, 477 U.S. at 323-24).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,*475 U.S. 574, 586 n.11 (1986); *Vandalia Park,*DAB No. 1939 (2004); *Lebanon Nursing and Rehab. Ctr.,*DAB No. 1918 (2004); *Crestview Parke Care Ctr*., DAB No. 1836 at 5 (2002).
General denials do not satisfy a party’s burden to identify *specific* evidence demonstrating a material fact is in dispute.  *Shah v. Azar*, 920 F.3d 987, 995-96 (5th Cir. 2019); *Forsyth v. Barr*, 19 F.3d 1527, 1533 (5th Cir. 1994); *Pearsall Nursing & Rehab.*, DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner “refers broadly to ‘the evidence presented in [its] response’” but “identifies no specific evidence relevant to the material facts.”); *Ill. Knights Templar*, DAB No. 2274 at 4 (finding that the non-moving party must furnish admissible evidence of a dispute concerning a material fact); *Livingston Care Ctr*., DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.”  *West Texas LTC Partners, Inc.*, DAB No. 2652 at 6 (2015), *aff’d sub nom. West Texas LTC Partners, Inc. v. U.S. Dep’t. of Health & Human Servs.*, 843 F.3d 1043 (5th Cir. 2016); *1866ICPayday.com L.L.C.*, DAB No. 2289 at 3 (2009) (quoting *Matsushita Elec. Industrial Co. v. Zenith Radio*, 475 U.S. at 587).
In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all *reasonable* inferences in the light most favorable to the non-moving party.  *Brightview Care Ctr.*, DAB No. 2132 at 2, 9 (2007); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.,* DAB No. 1943 at 8 (2004); *see also Brightview*, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party *does not require that I accept the non-moving party’s legal conclusions*.  *West Texas LTC Partners, Inc.*, DAB No. 2652 at 6-7, 14-15; *cf. Guardian Health Care Ctr.*, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed, and there is only one reasonable conclusion that can be drawn from those facts.”); *see Green Valley Health Care and Rehab. Ctr.*, DAB No. 2947 at 8 (2019) (quoting*Johnson v. Perez*, 823 F.3d, 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”)).
Page 6
**Summary judgment applied to administrative review in Medicare cases**.  It is well-established that an administrative law judge is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  *Shah v. Azar*, 920 F.3d 987, 996 (5th Cir. 2019) (citing *Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 619 F.3d 453, 457 (5th Cir. 2010)); *see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs.*, 604 F.3d 445, 449 (7th Cir. 2010).5
  Nevertheless, there seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some ill-informed advocates suggesting that, to do so, denies a party a fundamental right.  In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals gave lie to such misconceptions:  “All it means for a decision to be based on a grant of summary judgment is that there are *no issues that would benefit from being resolved in an evidentiary hearing*.”  *Fal-Meridian*, 604 F.3d at 449 (emphasis added).
Here, Petitioner argues that CMS is not entitled to summary judgment because it did not meet its “burden of presenting documentary evidence, including affidavits or declarations, which[,] if unrebutted, would show the elements of its prima facie case.”  P. Response at 3.  But Petitioner confuses the moving party’s obligations with those of the opposing party.  As explained in my initial order:
I will decide each motion for summary disposition according to the principles of Rule 56 of the Federal Rules of Civil Procedure and applicable case law.  A party moving for summary disposition *need not* offer supporting affidavits or exhibits, but it must state concisely in its motion those material facts it contends are not in dispute.  A party *opposing a motion for summary disposition must come forward with evidence* of specific facts showing that a dispute exists.  It is never sufficient for a party opposing to aver that it “disputes” alleged facts or that it demands an in-person hearing.
Page 7
Acknowledgment and Pre-hearing Order at 4 (¶ 4.a) (December 14, 2017) (emphasis added); *see* CRD Procedures at 18 (¶ 19a.iii).  The cases upon which Petitioner relies – *Wallace v. Texas Tech Univ.*, 80 F.3d 1042, 1047 (5th Cir. 1996) and *Huckabay v. Moore*, 142 F.3d 233, 240 (5th Cir. 1998) – address the *non-moving party’s* obligation to come forward with evidence.  While the non-moving party does not have to prove its case to avoid summary judgment, it must come forward with specific evidence sufficient to establish a dispute over a material fact.
Moreover, CMS has submitted ample evidence to establish that it is entitled to judgment as a matter of law.  CMS Exs. 1-20.  Petitioner suggests that CMS’s evidence should not be considered because it is inadmissible, for reasons Petitioner does not exactly explain, alluding generally to its not having been “authenticated” or “submitted with an affidavit.”  P. Response at 3.  Not only is Petitioner’s argument legally unsound, it is factually inaccurate.  CMS’s documents are accompanied by the written declarations of its witnesses, CMS Exs. 12, 15-17.  Moreover, even if Petitioner had proffered cogent objections to CMS’s proposed exhibits (which it did not), it is simply too late for Petitioner to object to their admissibility.  My pre-hearing order specifies that Petitioner *must* include in its pre-hearing exchange any objections that it has to any of the proposed exhibits or witnesses identified in CMS’s pre-hearing exchange.  Pre-hearing Order at 5 (¶ 6).  Petitioner did not then object and has therefore waived its right to do so.
Petitioner also argues that CMS’s evidence should not be considered because it was filed as part of CMS’s pre-hearing exchange rather than with the motion itself.  P. Response at 3.  This is nonsense.  A party is not required to re-submit the documents it has already properly submitted.
In its pre-hearing submissions, Petitioner did not respond to three of the deficiencies cited – 42 C.F.R. §§ 483.45(h)(1) and (2), 483.60(i), and 483.90(a) – and has therefore waived its right to challenge those findings.  *See* Pre-hearing Order at 3-4 (¶ 3), CMS MSJ at 1 n.2.  Although in its response to CMS’s motion, Petitioner refers briefly to section 483.45(h), it has waived its right to challenge that deficiency, and, as discussed below, even if it hadn’t, its passing reference to the regulation does not demonstrate that a material fact is in dispute.
With respect to the other deficiencies, Petitioner confuses facts with conclusions and relies on general denials, but does not identify specific evidence demonstrating a material fact in dispute.  Conclusory statements that are unsubstantiated by evidence of specific facts are insufficient to create a genuine factual dispute and do not preclude summary judgment.  *See* *Guardian*, DAB No. 1943 at 11 (characterizing as “conclusory in nature” claims that the facility provided “effective,” “appropriate,” or “aggressive” interventions.).
Page 8
As the following discussion shows, no material facts are in dispute, and CMS is entitled to judgment as a matter of law.
***1.  CMS is entitled to summary judgment because the undisputed evidence establishes that the facility did not properly store its drugs, which created the potential for staff to divert those drugs.  Because it failed to store its drugs properly, the facility not in substantial compliance with 42 C.F.R. § 483.45(h)(1) and (2).***6
**Program requirement:  42 C.F.R. § 483.45(h)(1) and (2) (Tag F431)**.  In accordance with state and federal law, the facility *must* store *all* drugs and biologicals *in locked compartments* under proper temperature controls; it must limit access to the keys to authorized personnel.  For drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, the facility must provide separately locked, permanently affixed compartments for storage, unless it uses single unit package drug distribution systems in which the quantity stored is minimal, and a missing dose can be readily detected.
Federal drug laws allow long-term-care facilities to dispose of controlled substances, but they must comply with federal regulations.  21 U.S.C. § 822(g)(3); 21 C.F.R. § 1317.80. Among the regulatory requirements, the disposal bin must be locked and located in a secure area that is monitored regularly.  21 U.S.C. § 1317.75(d)(2)(iii), (e)(2).
**Facility policy:  drug disposal**.  The facility had a written policy on disposing of medications.  It specifies that discontinued medications or medications not sent with a discharged resident must be stored in an area that is secure and separate from the facility’s active medications.  Medications awaiting disposal or return are stored in a locked and secured area, designated for that purpose, until destroyed or picked up by the pharmacy.  CMS Ex. 4 at 4-5; CMS Ex. 15 at 3 (Riojas Decl. ¶ 6C).
Failing to comply with its own policies supports the finding that the facility was not in substantial compliance with regulatory requirements.  *Bivens Memorial Nursing Home*, DAB No. 2771 at 9 (2017); *Life Care Ctr. of Bardstown*, DAB No. 2233 at 21-22 (2009).
**The facility’s practices:  drug storage and disposal**.  Responding to a police report that narcotics and other drugs were found in the home of a facility nurse, a survey team went to the facility, completing its investigation on September 22, 2017.  CMS Ex. 13; CMS Ex. 15 at 1 (Riojas Decl. ¶ 3).  The facility nurse – later identified as “LVN (Licensed Vocational Nurse) A” – had told police that the drugs they found in her home would otherwise have been disposed of, so Surveyor Brandie Riojas inspected the facility’s
Page 9
medication storage room and its practices for disposing of medications.  CMS Ex. 13 at 3; CMS Ex. 15 at 2 (Riojas Decl. ¶ 6C).  The facility’s drug storage room contained both active medications and medications that were intended for disposal.  A disposal bin was in the room; it was similar to a trash receptacle, with a padlocked lid.  The lid had a “plus sign style cut out” through which medications could be deposited into the bin.  However, Surveyor Riojas saw eight bags of intravenous antibiotics (Rocephin and Vancomyacin) *sitting on top of* the medication disposal bin.  With the disposal bin was a clipboard with log sheets on which staff were supposed to document the discarded medications.  Staff had not added the discarded antibiotics to the log sheet.  CMS Ex. 4 at 3-4; CMS Ex. 15 at 2 (Riojas Decl. ¶ 6C).
The facility’s Director of Nursing (DON), Christina Cormier, RN, told Surveyor Riojas that staff probably left the drugs on top of the bin because the bags would not fit through the cut-out on the bin’s lid.  She had not been monitoring the bin regularly enough to notice that the drugs had been left out.  Had staff informed her (as they should have), she’d have unlocked the bin so that the drugs could be disposed of properly.  Both she and the consultant pharmacist agreed that the medications should have been secured.  CMS Ex. 15 at 3 (Riojas Decl. ¶ 6C).  The DON apparently did not explain why staff failed to log the medications they had discarded.
Petitioner disputes none of these facts.  The DON’s written declaration says nothing about LVN A’s drug diversion or the facility’s irregularities in disposing of medications.  Petitioner’s prehearing brief does not even mention the deficiency or the September 22 survey.  By failing to raise an argument in its pre-hearing brief, Petitioner has conceded that it was not in substantial compliance with section 483.45(h).  *See* Prehearing Order at 3-4 (¶ 3).
Moreover, Petitioner’s subsequent half-hearted attempts to challenge CMS’s finding would fail even if raised timely.  In responding to CMS’s motion for summary judgment, Petitioner points to the statement of deficiencies for the September 22 survey and argues that, based on those findings, no drug diversion occurred, so the facility was in compliance with the regulation.  P. Response at 12.  This is a conclusion, not a fact, and the undisputed evidence establishes otherwise.
It is well-settled that CMS is not limited to the specific allegations included in the Statement of Deficiencies.  As the Departmental Appeals Board has repeatedly explained, the Statement of Deficiencies is a notice document, not intended to “lay out every single detail in support of finding that a violation has been committed.”  *Alden Town Manor Rehab. & HCC*, DAB No. 2054 at 17 (2006) (citing*Pacific Regency Arvin*, DAB No. 1823 at 9-10 (2002)).  So long as the facility knows what it must answer to – which, as here, was accomplished through pre-hearing record development – the facility has sufficient notice.
Page 10
Moreover, CMS came forward with dispositive evidence showing that one of the facility’s nurses removed narcotics from the facility and, when caught, told police that the drugs would have been disposed of if she hadn’t taken them.  CMS Ex. 13; CMS Ex. 14 at 4-5.  She was disciplined for diverting those drugs.  P. Ex. 7 at 3; *see* CMS Ex. 10 at 12, 14.  When Surveyor Riojas investigated the facility’s practices in disposing of drugs, she found that, contrary to the federal regulation and the facility’s own policy, the facility did not store all of its drugs in locked compartments.  Its active medications were kept in the same location as those that were to be disposed of.  The facility’s DON was not adequately monitoring disposal of the medications.  CMS Ex. 4 at 3-5; CMS Ex. 14 at 13; CMS Ex. 15 at 2-3 (Riojas Decl. ¶ 6C).  These irregularities explain why a nurse was able, without detection, to remove narcotics from the facility and, even if she had not done so, the deficient practices created the “potential to cause drug diversion from staff.”  CMS Ex. 4 at 3; CMS Ex. 14 at 13; CMS Ex. 15 at 3 (Riojas Decl. ¶ D).  Petitioner has produced no evidence suggesting a dispute over any of these facts, and has not suggested any reasonable alternative inferences to be drawn from them.
Because the undisputed evidence establishes that the facility did not properly secure its drugs and monitor their disposal, it was not in substantial compliance with section 483.45(h)(1) and (2).
***2.  CMS is entitled to summary judgment because the undisputed evidence establishes that the facility’s sprinkler system was not maintained in accordance with NFPA standards, which put the facility out of substantial compliance with 42 C.F.R. § 483.90(a).***
**Program requirement:  42 C.F.R. § 483.90(a) (LSC §§ 9.7.5, 9.7.7, 9.7.8 and NFPA 25) (Tag K353)**.  The facility must be designed, constructed, equipped, and maintained to protect the health and safety of residents, personnel, and the public.  42 C.F.R. § 483.90.  To this end, it must, among other requirements, meet the applicable provisions of the LSC, NFPA 101.  The LSC requires that the facility’s sprinkler system be inspected, tested, and maintained in accordance with NFPA 25, which requires that the facility maintain, in a secure location, records of system design, maintenance, inspection, and testing.  The records must be readily available and should reflect the date the system was last checked, the name of the person testing, and the water system supply source.
**The facility’s sprinkler system**.  Life Safety Code Surveyor Bryan Scott Epperson observed sprinkler heads that were “covered with foreign material,” compromising the sprinkler’s effectiveness.  CMS Ex. 3 at 4; CMS Ex. 17 at 2 (Epperson ¶ 6C, D).  He also observed that the sprinkler piping in the attic space was supporting non-system cables, ducting, water pipes, abandoned iron piping and wiring.  The sprinkler system was not intended to support such non-system components.  CMS Ex. 3 at 3-4.; CMS Ex. 17 at 2 (Epperson Decl. ¶¶ 6B, C).
Page 11
Petitioner produces no evidence suggesting that it disputes any of Surveyor Epperson’s observations.  In fact, Petitioner has not disputed either CMS’s factual account or its conclusions of law on this issue.
Because the sprinkler system was not properly maintained, the facility was not in substantial compliance with section 483.90(a).
***3.  CMS is entitled to summary judgment because the undisputed evidence establishes that the facility’s kitchen staff did not store food at safe temperatures, putting the facility out of substantial compliance with 42 C.F.R. § 483.60(i).***
**Program requirement:  42 C.F.R. § 483.60(i)(1)-(3) (Tag F371)**.  The facility must procure food from approved sources or sources considered satisfactory by federal, state, or local authorities.  It must *store,*prepare, distribute, and serve*food in accordance with professional standards for food service safety*.
**Facility policy:  storage of refrigerated foods**.  The facility had in place a written policy on storing refrigerated foods.  The policy requires that potentially hazardous foods be properly refrigerated or frozen to prevent food borne illness and to maintain product integrity.  The policy characterizes refrigerated storage as “essential” for potentially hazardous foods and for most perishable foods, in order to slow microbial growth and control food quality.  Foods *must* be kept in refrigerated units at or below *41oF*.  CMS Ex. 8 at 4.
The policy requires an internal thermometer in all refrigerators.  The temperature should be checked and logged a minimum of twice daily, once in the morning and once in the evening.  Temperatures must be recorded on a temperature log.  At the time of discovery, staff should report to the dietary service manager and maintenance director or administrator any temperature outside the required parameter.  A notation on the back of the temperature log should include the date, time, and the person notified.  If the temperature continues to rise, rather than fall, all food must be moved to a different unit as soon as possible.  CMS Ex. 8 at 4.
**The facility’s food storage practices**.  At 11:15 a.m. on September 27, 2017 (during the survey completed September 30), Nutritionist Surveyor Gary N. Bailey, D.M., observed that the temperature of the facility’s walk-in refrigerator was *51oF*, ten degrees higher than the temperature deemed acceptable in the facility policy.  The facility’s dietary manager took the temperature of foods in the refrigerator, including yogurt, which registered a temperature of 47oF.  Surveyor Baily testified that a refrigerator should be cold enough to maintain internal food temperatures of 41oF or lower, even during a defrost cycle.  CMS Ex. 16 at 2 (Baily Decl.).  According to the temperature log for that
Page 12
refrigerator, its internal temperature had measured 50oF during the breakfast shift that day.  CMS Ex. 16 at 3 (Baily Decl.).
The facility’s dietary manager told Surveyor Bailey that she was not aware of a problem with the refrigerator.  She acknowledged that staff should have advised her of the temperature, taken random temperatures of the food in the refrigerator, and called the service company.  A facility cook agreed that she should have taken the temperatures of refrigerated items and notified her supervisor, but said that she assumed that the unit was on defrost and would cool back down.  CMS Ex. 16 at 3.  The service company repaired the refrigerator that day.  *Id*.
Petitioner challenges none of this.  Because the facility did not meet professional standards for food safety, it was not in substantial compliance with 42 C.F.R. § 483.60(i).
***4.  CMS is entitled to summary judgment because the undisputed evidence establishes that staff did not transcribe or implement physician orders, as required by the regulations and the facility’s policies; a vulnerable resident did not receive the goods, services, and treatment he needed to avoid physical harm and emotional distress and to maintain his highest practicable physical, mental, and psychosocial well-being.  These failures put the facility out of substantial compliance with 42 C.F.R. §§ 483.12(b)(1)-(3), 483.95(c),******483.24, 483.25, and 483.45(f)*****.**
**Program requirement:  42 C.F.R. §§ 483.12(b)(1)-(3) and 483.95(c) (Tags F224, F226)**.  “Neglect” is the failure of the facility, its employees, or service providers to provide a resident with the goods and services necessary to avoid his suffering physical harm, pain, mental anguish, or emotional distress.  42 C.F.R. §§ 483.5, 488.301.  A facility resident has the right to be free from abuse, neglect, and exploitation.  42 C.F.R. § 483.12.  To this end, facilities must develop and implement written policies and procedures that prohibit and prevent abuse, neglect, and exploitation of residents.  It must establish policies and procedures to investigate any such allegation.  42 C.F.R. § 483.12(b)(1) and (2).  It must train its staff on:  1) activities that constitute abuse, neglect, and exploitation; 2) procedures for reporting abuse, neglect, and exploitation; and 3) dementia management and resident abuse prevention.  42 C.F.R. §§ 483.12(b)(3), 483.95(c).
**Program requirement:  42 C.F.R. §§** **483.24 and 483.25 (Tag F309)**.  The regulations characterize “quality of life” and “quality of care” as “fundamental” principles that apply “to all care and services provided to facility residents.”  Under the Medicare statute and these regulations, each resident must receive, and the facility must provide, necessary treatment and care to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and person-centered care plan.  Act § 1819(b); 42 C.F.R.
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§§ 483.24, 483.25.  The regulations impose on facilities an affirmative duty designed to achieve favorable outcomes “to the highest practicable degree.”  *Windsor Health Care Ctr.*, DAB No. 1902 at 16-17 (2003), *aff’d* *sub nom.* *Windsor Health Care Ctr. v. Leavitt*, No. 04-3018 (6th Cir. 2005); *Woodstock Care Ctr.*, DAB No. 1726 at 25-30 (2000), *aff’d sub nom. Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).
**Program requirement:  42 C.F.R. § 483.45(f)(2) (Tag F333)**.  The facility must provide routine and emergency drugs to its residents and must ensure that its residents are free of any significant medication errors.
**Facility policy: transcribing physician orders**.  The facility had in place a policy for transcribing or noting and discontinuing physician orders.  The policy notes that “when a physician order is completed,” staff *must* transcribe or note the information received on the appropriate forms to ensure that staff provide appropriate care.  The physician instructions are *entered onto a physician order form* and *then transcribed* or noted on the medication administration record (MAR) or treatment administration record (TAR) and/or other designated areas, such as the electronic physician order system, or calendar.  CMS Ex. 8 at 2.
The policy directs staff to:
Rely on a copy of the written physician order – *not memory* – when transcribing the order onto another form or location;
	Verify that the resident name and the name on the physician orders match;
	After transcribing, document the signature, credentials, and date on the physician order;
	The charge nurse is responsible for transferring physician orders onto the MAR, TAR, or other designated area;
	The assistant director of nursing (ADON) or designee validates the order and transcription and then enters the physician order into the electronic physician order system.For transcribing medication and treatment orders, the policy provides that:
Staff document the times that prescribed medications or treatments are administered “according to center specified practice”;Page 14
If general administration times are ordered, the treatment “may be assigned [to] a shift for administration based upon work-load distribution or center practices”;
	Staff should document “order administration interruptions” by blocking out the MAR or TAR documentation spaces for the month;
	If the physician changes the dosage, staff should rewrite medication orders on the MAR; discontinue the previous order, enter the date and initial;
	Staff should document, on the MAR or TAR, medications or treatments with ordered stop-dates;
	The policy includes instructions for orders that carry-over into the next month, but, frankly, the instruction is incomprehensible:  “Ensure carry-over of medication orders to the next month’s MAR or TAR when medication or treatments has [sic] an ordered stop-date to prevent any interruptions of an ordered medication or treatment, e.g., antibiotic is for 10 days.  Eight (8) days or medication have [sic] been given by the end of the month; ensure the last (2) days of the next month there is a carry-over of the medication order”;7
	Laboratory orders are documented onto “the requisition” and are transcribed according to center practices;
	Scheduled appointments should be documented on the unit calendar or “other center specified location per center practices”;
	New orders may be documented on the 24-hour report form;
	The MAR and the TAR are considered part of the patient’s care plan.CMS Ex. 8 at 2-3.
The policy includes additional instructions for discontinuing medication or treatment:
A physician order is necessary to discontinue an ordered medication or treatment;
	Staff must document on the MAR, TAR, care plan, nurse aide data flow record or information sheet, or in other specified location.  Staff should fill in, using a highlighter, the remaining spaces on the MAR, TAR, and corresponding areas ofPage 15
the care plan, nurse aide data flow record, or other care provision documents; in the yellow area, write d/c, date, and initial; discontinued orders may be documented on the 24-hour report form.
CMS Ex. 8 at 3.
**Facility policy:  insulin management**.  The facility had a policy in place for managing insulin:  staff must follow the physician’s *individualized plan* for managing diabetic residents requiring insulin therapy.  According to the policy, routine administration is “generally preferred.”  If a resident’s glucose levels cannot be managed effectively with routine insulin, the physician may order administration based on a sliding scale, which is determined by a finger stick blood sugar reading.  *“Due to wide variance in resident’s response” to insulin therapy, each resident’s physician must individualize the sliding scale.*  CMS Ex. 8 at 6 (emphasis added).
The policy sets out the following procedures:
A licensed nurse follows the physician’s *individualized* insulin orders for each resident receiving insulin therapy;
	The nurse will monitor the resident for signs and symptoms of hyper and hypoglycemia, including the results of any finger stick blood sugars;
	Staff will notify the physician of any symptoms of hyper or hypoglycemia and if a resident’s blood glucose readings are *outside the parameters outlined by the physician*;
	Hyperglycemia will be managed based on the physician’s specific orders, which may include adjusting the resident’s insulin dosage;
	Hypoglycemia response:  if the resident is unresponsive, administer Glucagon 1 mg.  If the resident is responsive, the licensed nurse should administer a protein with a carbohydrate, e.g. two ounces of Med Pass/Med Plus or eight ounces of milk and a graham cracker.Finally, the policy *requires documentation*.  Insulin and finger stick *blood sugar readings must be recorded* in the resident’s MAR and in the nurses’ notes.  The policy lists a diabetic patient’s unresponsive symptoms (severe hypoglycemia):  disoriented behavior; loss of consciousness; inability to rouse from sleep; inability to swallow; seizures.  It lists “diabetic unresponsive symptoms” (hyperglycemia):  headaches; blurred vision; fatigue; weight loss; increased thirst; frequent urination; difficulty concentrating/altered mental status.  CMS Ex. 8 at 6.
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**Facility policy:  administering and documenting medications**.  The facility had a written policy for administering and documenting medication and treatments.  It provides that, unless otherwise indicated by a physician’s order, medications should be administered according to the manufacturer’s guidelines.  CMS Ex. 8 at 7.
Staff (licensed nurses and certified medication aides) must:
Verify labels accurately to reflect physician orders on the MAR and TAR prior to administering patient medications and treatments;
	Verify administration accuracy by checking the medication with the MAR three times;
	Verify and provide medication or treatment-focused assessment as indicated by the manufacturer’s guidelines or physician orders;
	*Administer the medication according to the physician order*;
	Immediately following administration, document initials and/or signature on the MAR or TAR for the medication or treatments administered;
	When a controlled medication is administered, the licensed nurse obtains it from the locked area.  The nurse administers the medication and immediately enters date and time of administration into the accountability record; he/she signs the record.  The nurse also documents on the MAR that the medication was administered;
	If medications or treatment are not administered, staff should circle the initials and, on the back of the MAR or TAR, document the reason why it wasn’t administered;
	When a dose of a controlled medication is removed from the container but is refused or not given, *it must be destroyed with two nurses witnessing*.  Both nurses must sign the accountability record on the line representing the dose;
	Staff should check the “E Box list” if a medication is not available and should verify its availability with the pharmacy;
	Staff should notify the physician when medications or treatment will be available, provide information regarding medications in the E Box and document the physician response;Page 17
Immediately after administration, staff should document PRN (as needed) medication and treatment administration, giving the reason for the administration and its effectiveness;
	Staff are to review the MAR and TAR after administering medication/treatment, and before the end of the shift in order to validate that the documentation is complete and that support services were provided according to physician orders;
	Staff should document on the 24-hour-report any omission or held medication/treatment;
	Staff must complete a medication error report for “medication administration discrepancies”;
	During the shift-to-shift report, at the time of a shift change, the nurse must provide a summary of the medication/treatment administration issues to the on-coming charge nurse or certified medical assistant.CMS Ex. 8 at 7-8.
**Facility policy:  abuse (and neglect)**.  Finally, the facility had in place a policy for preventing abuse and neglect.  It reiterates the regulatory requirement that residents be free from abuse, neglect, misappropriation of property, and exploitation.  CMS Ex. 8 at 9; 42 C.F.R. § 483.12.
Specifically addressing neglect, the policy requires that *all* alleged violations involving *neglect be reported “immediately, but not later than [two] hours after the allegation is made*.”  The report must be given to the facility administrator and other officials, including to the state survey agency.  CMS Ex. 8 at 9 (emphasis added).
Among other training requirements, the facility must train its employees, through orientation and on-going sessions in:  *how to report “knowledge of a suspicion* of a crime, abuse, or witnessed abuse, neglect, or misappropriation of resident property”; and “*what constitutes* abuse, *neglect*, and misappropriation of resident property.”  CMS Ex. 8 at 10 (emphasis added).  It must also train staff on activities that constitute abuse or neglect and coordinate investigations with the QAPI (quality assurance/performance improvement) program.  CMS Ex. 8 at 11.
A committee selected and chaired by the facility administrator, or designee, functions as the Quality Assurance and Assessment Committee.  It must meet at least quarterly to review, evaluate and identify situations in which abuse or neglect is more likely to occur.  CMS Ex. 8 at 11.  The facility must be proactive in identifying events and occurrences that may contribute to abuse or neglect.  CMS Ex. 8 at 12.
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The facility must investigate different types of incidents and identify the staff members responsible for (1) the initial reporting, (2) investigating the alleged violations, and (3) reporting the results to the proper authorities.  It must have evidence that *all violations – including allegations* – are thoroughly investigated.  CMS Ex. 8 at 12.
In one extremely problematic provision, the policy makes the “abuse coordinator,” who is also the QAPI chair, the director of investigations and proclaims that “*therefore investigative documents are QAA protected/confidential*.”  CMS Ex. 8 at 12 (emphasis added).  This transparent attempt to conceal the investigation from regulators violates section 483.12(c), which requires that facilities thoroughly investigate and report the results of its investigation.  A facility may not avoid scrutiny of its deficiencies by referring them to the quality assurance committee for study.  As the Board explained in *Jewish Home of Eastern Pa.*, “It would be strange indeed if the very documentation [that] a facility is required to generate for [the purpose of reporting to the state agency] were also shielded from those very regulators whenever it has been reviewed by a QA Committee or whenever an individual whose responsibilities include conducting or documenting such investigations also serves on a QA committee.”  DAB No. 2254 at 11 (2009), *aff’d sub nom. Jewish Home of Eastern Pa. v. Centers for Medicare & Medicaid Servs*., 413 F. App’x 532 (3rd Cir. 2011); *Cedar Lake Nursing Home*, DAB No. 2288 at 11-12 (2009).
The policy requires that the results of the investigation be reported to the administrator and other officials within five working days of the incident.  If verified, appropriate corrective and disciplinary action will be taken.  CMS Ex. 8 at 12.8
Incidents of alleged abuse and neglect must be reported to the appropriate local, state, and federal agencies.  The incidents must *immediately be reported to the facility administrator or DON*.  If neither is available, incidents should be reported to the charge nurse or supervisor in charge, who must immediately contact the administrator or DON.  The nurse must document all incidents of alleged abuse/neglect on the “Grievance Form,” which may include the 24-hour report.  CMS Ex. 7 at 93.
All incident reports must go to the administrator or DON if the administrator is not available.  The administrator or designee must immediately begin an investigation, following state investigation guidelines, which include:  resident and responsible party interviews; physical examination; staff interviews and written statements; collaboration with state agencies; and methods to support the individual and prevent further victimization.  The results of all investigations must be reported to the administrator or
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designee and other officials in accordance with state law within five working days of the incident. CMS Ex. 7 at 94.
**Facility policy:  neglect**.  In a separate, undated policy (which may have been generated after the September 20 incident), the facility defines neglect as “the failure to provide care, services, medications or other goods needed by a resident.”  Among the examples listed is *failing to give a resident medications as prescribed*.  The policy directs staff to make themselves familiar with the residents and their care plans, to understand the care and services required, and *to document diligently the physician orders* so that the resident receives the prescribed care.  If staff suspect neglect, they must immediately notify the administrator or, if not available, notify the DON or ADON.  They should also assess the resident and, if the resident has a negative outcome, notify the physician.  CMS Ex. 7 at 96.
**Resident 11 (R11)**.  R11 was an 81-year-old man, suffering from diabetes mellitus, heart failure, hypertension, low back pain, muscle weakness, dysphagia – oropharyngeal phase (difficulty swallowing), cognitive deficit, and depression.  CMS Ex. 6 at 9.  His treatment records show that his blood sugar levels were usually between 151 and 250, particularly in the evening.  CMS Ex. 6 at 14; CMS MSJ at 2; P. Br. at 6 n.1.
Although Petitioner initially agreed that R11’s blood sugar levels generally fell between 151 and 250 (P. Br. at 6 n.1), in responding to CMS’s motion for summary judgment, it faults CMS for identifying, as an undisputed fact, that LVN A recognized that a blood sugar level of 78 was low for R11.  P. Response at 5.  Petitioner asserts that a blood sugar level of 78 is within normal parameters for a person with diabetes.9
  From this, Petitioner argues that “[t]his issue of material fact is essential to the determination of whether LVN ‘A’ failed to take immediate action after obtaining the 78 reading, thereby neglecting him in violation of the regulations at issue.”  P. Response at 5.  In making this argument, Petitioner ignores R11’s medical record, his physician opinion, the facility’s policies for treating residents with diabetes, as well as the regulation itself.
“Normal” blood sugar levels are not what matters.  As the regulations and the facility’s policies emphasize, the question is what blood sugar levels were normal and safe for R11.  42 C.F.R. § 483.25 (requiring that care be based on a “person-centered care plan”); CMS Ex. 8 at 6 (acknowledging the “wide variance” in resident responses to insulin therapy and requiring staff to follow the physician’s *individualized plan* for managing a diabetic resident’s insulin therapy).  And the undisputed evidence establishes that R11’s blood
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sugar levels were normally very stable, usually between 151 and 250.  A reading of 78 was abnormally low for him, and, when his blood sugar dropped to that level, he became quite ill.  CMS Ex. 2 at 4-5; CMS Ex. 6 at 7, 14; CMS Ex. 10 at 13; CMS Ex. 12 at 3, 7 (Brown Decl. ¶ 6C); P. Ex. 2 at 2 (Ramsey Decl. ¶ 5); P. Br. at 6 n.1.
To control his blood sugar levels, R11’s physician prescribed insulin – Humulin 70/30, 100 units/ml.  He was supposed to receive 15 units twice a day.  CMS Ex. 6 at 10; P. Ex. 2 at 1 (Ramsey Decl. ¶ 4).  Among other instructions, the physician directed staff to administer six ounces of “Med plus 2.0” (a nutritional supplement) if his fasting blood sugar fell below 60 and he remained responsive, then to check his blood sugar *every 15 minutes* until it was greater than 60.  If, after *30 minutes*, his blood sugar was still below 60, staff were to call his physician or send him to the emergency room.  If his blood sugar level was below 60, and he was not responsive, the physician ordered staff to administer Glucagon (a hormone that treats low blood sugar), 1 mg IM (intramuscular injection) and to notify him, as needed.  CMS Ex. 6 at 9; P. Ex. 2 at 1-2 (Ramsey Decl. ¶ 4).
**Facility practice in administering insulin**.  CMS presents undisputed evidence of the facility’s practice in administering insulin.  The responsible nurse (in this case, LVN A)  placed two bottles of insulin on the medication cart:  Humulin 100, which was the appropriate strength for R11; and Humulin 500, which was five times stronger and ordered for another resident.  LVN A told Surveyor Katelyn Brown that she administered insulin from one of the two bottles on the medication cart and that she suspected, but did not know, that she administered the incorrect dosage to R11.  CMS Ex. 2 at 5; CMS Ex. 12 at 3 (Brown Decl.).
R11’s physician, Dr. David Ramsey, confirmed that the facility kept the bottles together on the medication cart, and he told Surveyor Brown that he had cautioned the facility against keeping the U500 insulin next to the regular insulin, pointing out that it could cause medication errors “such as this.”  CMS Ex. 2 at 7-8; CMS Ex. 10 at 14; CMS Ex. 12 at 4 (Brown Decl. ¶ 6C).  Petitioner denies – without support – that Dr. Ramsey made such a statement.  Petitioner does not come forward with any evidence suggesting a dispute on this issue, but asserts (incorrectly) that the surveyor notes don’t include such a statement, which, in Petitioner’s view, creates a material fact in dispute.  P. Response at 4.  In these circumstances, I do not consider that pointing to the absence of a surveyor note is sufficient to create a material fact in dispute, particularly since it would be so easy for Petitioner to produce actual evidence of its practices.  But none of that matters because the surveyor’s note *does* refer to the physician warnings.  Although difficult to read, the note of Surveyor Brown’s conversation with Dr. Ramsey includes the following:  “Talked numerous times about how dangerous it is to keep U500 [with] regular insulin.”  CMS Ex. 10 at 14.
Even more significant, Dr. Ramsey submits a written declaration in which he does not deny telling Surveyor Brown that he warned facility staff that keeping both insulins
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together was dangerous nor that the facility continued the questionable practice, despite his warning.  P. Ex. 2 (Ramsey Decl.).  Further, DON Cormier also submits a written declaration in which she does not deny the practice nor that she had been warned against it.  P. Ex. 6 (Cormier Decl.).  It is therefore undisputed that, notwithstanding Dr. Ramsey’s warning, the facility continued to place the two bottles next to each other on the medication cart.
Petitioner also challenges CMS’s assertion that the insulin was kept in “multi-resident” bottles.  Petitioner argues that, if allowed to cross-examine Surveyor Brown, it would “likely establish that each bottle is prescribed for a specific resident and [is] not used for multiple residents.”  P. Response at 4.  The discussion of multi-resident use is baffling because it is irrelevant, and, in any event, no evidence suggests that this was the facility practice.  The notion seems to have come from CMS’s misreading of the survey report form, CMS Ex. 2 at 5.  But that document does not mention “multi-resident” bottles; it says “there are only two bottles of insulin on the medication cart.”  I do not infer from this statement that each bottle was intended for multiple residents.  Moreover, in her written declaration, Surveyor Brown does not claim that the bottles were “multi-resident,” so questioning her about that issue would go beyond her direct testimony, and I would not allow it.  CMS Ex. 12 (Brown Decl.).  And, as discussed above, if Petitioner wanted to establish its practices for dispensing medications, its own witnesses, particularly the DON or one of the nurses who administered medications, would be the appropriate witnesses to do so.  Yet, DON Cormier did not mention the methods by which medications were dispensed.  P. Ex. 6 (Cormier Decl.).
More important, the issue is irrelevant.  Whether the bottles held insulin for multiple residents (for which I’ve seen no evidence) was not the problem.  The problem was that the facility kept, next to each other on the medication cart, two bottles containing medications that were similar, but with vastly different strengths.  I agree with Dr. Ramsey’s opinion that it was a dangerous practice, putting diabetic residents at risk of receiving the wrong medication and becoming seriously ill.
**The September 20, 2017 incident**.  Notwithstanding her having “diverted” narcotics a few weeks earlier, LVN A continued to work at the facility.10
  At about 4:30 on the afternoon of September 20, she administered insulin to R11, and he promptly became
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very ill, dizzy and nauseous and, in his own words, he felt “like crap.”  CMS Ex. 2 at 4-5; CMS Ex. 6 at 7; CMS Ex. 10 at 13; CMS Ex. 12 at 3 (Brown Decl. ¶ 6C).
Dr. Ramsey told Surveyor Brown that R11’s blood sugar levels are “*normally very stable*” and that it was “out of character” for his blood sugar to drop below 100.  Based on that, the doctor believed that LVN A gave the resident the wrong type of insulin.  CMS Ex. 12 at 7 (Brown Decl. ¶ 6C) (emphasis added).  LVN A, herself, told the surveyors that she “realized that she might have given the wrong insulin” to R11.  CMS Ex. 10 at 18.
The facility’s documentation of this incident leaves a lot to be desired; it is incomplete, confusing, and not wholly consistent.  According to contemporaneous charting and the facility’s investigative report, at 4:00 p.m., R11’s blood sugar level was 286.  CMS Ex. 6 at 14, 75; CMS Ex. 7 at 4.  At 4:30 p.m., LVN A gave him insulin; he was alert, watching TV, “having no issues.”  He ate dinner.  At 9:00 p.m., LVN A again tested his blood sugar, and his level was 120.  CMS Ex. 6 at 14, 75; CMS Ex. 7 at 4.  This was low for R11, so LVN A re-tested; his blood sugar level was an abnormally low 78, although that value is not reported on the testing record.  CMS Ex. 6 at 75; CMS Ex. 7 at 4.
A nurse’s note indicates – and Dr. Ramsey confirms – that, sometime after dinner on September 20, R11’s blood sugar was 78.  CMS Ex. 6 at 7; P. Ex. 2 at 2 (Ramsey Decl. ¶ 5).  But the note is ambiguous and confusing, recording the 120 level *after* the 78 level.  CMS Ex. 6 at 7.  Dr. Ramsey refers to this note but does not claim that anyone actually told him that the resident’s blood level increased from 78 to 120, or that he otherwise had any independent knowledge of such a fluctuation.  Relying on his review of the note, he understandably (but possibly incorrectly) interprets it to mean that the resident’s blood sugar increased from 78 to 120, which seems unlikely in light of its otherwise unwavering decline throughout the evening.  P. Ex. 2 at 2 (Ramsey Decl. ¶ 6).
The ambiguity of the note and its possible inconsistency with the actual contemporaneous records, as well as its inconsistency with the investigative report, are themselves obvious problems, and it seems more likely, based on the blood test records, that the investigative report correctly concluded that R11’s blood sugar did not increase from 78 to 120, but instead declined from 120 to 78.  Ultimately, however, the issue is not material.  What matters is that, as R11’s blood sugar levels continued to fluctuate and fall, nurses did not follow physician orders in responding to the declining levels.
During the initial call, Dr. Ramsey directed LVN A to give the resident a peanut butter and jelly sandwich and to *check his blood sugar in 30 minutes*.  He also directed her to check R11’s blood sugar levels “often” and, “if they were still fluctuating, to start a bag of DS [dextrose saline] IV fluids.”  P. Ex. 2 at 2 (Ramsey Decl. ¶ 5).  Contrary to facility policy, LVN A did not write down or transcribe the physician order.  *See* CMS Ex. 8 at 2.
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And no evidence suggests that she checked R11’s blood sugar levels “often”; her nurse’s notes record just one additional blood sugar level – 79 at 10:45 p.m.  CMS Ex. 6 at 6-7.
Following her conversation with Dr. Ramsey, LVN A held R11’s evening insulin, gave him peanut butter and crackers, and, according to Dr. Ramsey, “continued to monitor him.”  P. Ex. 2 at 2 (Ramsey Decl. ¶ 6).  Later that evening, LVN A may have called Dr. Ramsey to report that R11’s blood sugar levels continued to fluctuate.  Again, she did not document the call, and Dr. Ramsey does not indicate what time she placed it.  P. Ex. 2 at 2 (Ramsey Decl. ¶ 7).  The investigative report does not mention a second call.  CMS Ex. 7.  Nevertheless, Dr. Ramsey asserts that LVN A reported that R11’s levels were still fluctuating and the latest reading was 79.  P. Ex. 2 at 2 (Ramsay Decl. ¶ 7).
Petitioner suggests that whether the nurse called Dr. Ramsey a second time is a material fact in dispute.  P. Response at 5.  The facility is, of course, responsible for this ambiguity – which is directly attributable to its poor record-keeping – and should not benefit from its own inadequacies.  Nevertheless, Dr. Ramsey indicates that LVN A called a second time, and, for purposes of summary judgment, I accept his statement as true.  P. Ex. 2 at 2 (Ramsey Decl. ¶¶ 5, 7).  But the issue is not material.  CMS has not faulted the facility for failing to consult the physician (42 C.F.R. § 483.10(g)(14)).  Rather, CMS faults the facility for myriad other failings with respect to R11, which put the facility out of substantial compliance with other program requirements.
LVN A told Surveyor Brown that she called R11’s physician at about 9:00 p.m.  She said that Dr. Ramsey ordered her to start an IV and to monitor the resident’s blood sugars.  Dr. Ramsey, however, denies that he ordered her to start the IV at that time.  He claims that he ordered the IV “only if [R11’s] blood sugar continued to drop.”  CMS Ex. 2 at 5-6; CMS Ex. 10 at 18; CMS Ex. 12 at 2 (Brown Decl. ¶ 6B); P. Ex. 2 at 2 (Ramsey Decl. ¶ 7).  These types of discrepancies – not surprising when staff fail to write down a physician’s telephone order – can have serious repercussions (as occurred here).
LVN A admitted that she “forgot” to transcribe the order and that she did not carry out the physician orders.  She did not start the IV; whether or how she monitored R11’s blood sugar is an open question because her documentation is so poor.  At shift change, she told LVN B about the possible medication error and gave her some version of the physician’s order.  CMS Ex. 2 at 5-6; CMS Ex. 6 at 5; CMS Ex. 10 at 18; CMS Ex. 12 at 2 (Brown Decl. ¶ 6B); P. Ex. 2 at 2 (Ramsey Decl. ¶ 7); P. Ex. 5.
The undisputed evidence establishes that one or both of the nurses made additional errors in conveying Dr. Ramsey’s orders.  In an incident report, dated September 22, LVN B writes that, before she started her (11:00 p.m. to 7:00 a.m.) shift, LVN A (who worked the 3:00 p.m. to 11:00 p.m. shift) reported that “she wasn’t sure but she thought” that she gave a resident another resident’s insulin.  Also according to LVN B, LVN A said that she’d called the doctor, who told her to give the resident something to eat and to take his
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blood sugar hourly.  If the level continued to drop, the nurse should start the IV.  P. Ex. 5.  But this was not the physician’s order; either LVN A conveyed the wrong information, or LVN B incorrectly recorded what LVN A told her.  CMS Ex. 6 at 9; P. Ex. 2 at 1-2 (Ramsey Decl. ¶ 4).
This is not surprising.  The facility’s policy is explicit:  “do not rely on memory.”  Per that policy, LVN A should immediately have written the order onto a physician order form and then transcribed it into the appropriate record.  CMS Ex. 8 at 2.  In this case, not only did LVN A rely on her memory rather than writing down the order, she *never* wrote down the order.  Instead, hours after she heard the order, she conveyed her memory of it to the night-shift nurse.  And we don’t know how much time elapsed between the time LVN B heard the order and the time she wrote it down because she did not record the time she wrote it down.  CMS Ex. 6 at 5; P. Ex. 5.
No one disputes that R11’s blood sugar level continued falling until it reached dangerously low levels.
According to a nurse’s note, LVN B monitored R11’s blood sugar levels *hourly* and fed him peanut butter crackers and Boost.  At midnight, R11’s blood sugar measured 67 (potentially harmful).  CMS Ex. 6 at 8, 12; CMS Ex. 12 at 4 (Brown Decl. ¶ 6C).  The LVN did not start an IV.  By 1:00 a.m., R11’s blood sugar was down to 53 (dangerously low); still, she did not start an IV.  Nor did she check his blood sugar level 15 or even 30 minutes later.  She checked again an hour later.  At 2:00 a.m., his blood sugar had dropped to 49, which could have resulted in seizures or even death.  LVN B then attempted, unsuccessfully, to start an IV.  She spoke to the facility’s DON and, at 2:35 a.m., called an ambulance.  DON Cormier told Surveyor Brown that, when she called, LVN B told her that LVN A gave the wrong insulin.  CMS Ex. 10 at 12.
The EMTs arrived at 2:40 a.m.  They immediately started an IV, giving R11 the glucose he so desperately needed.  His blood sugar shot up to 244.  When the EMTs took R11 to the hospital, he was alert but “slow.”  CMS Ex. 6 at 8; CMS Ex. 12 at 4 (Brown Decl. ¶ 6C); P. Ex. 6 at 2 (Cormier Decl. ¶ 6).  Facility staff told the EMTs that, at 4:00 p.m. the afternoon before, R11 was mistakenly given the highly concentrated (U500) insulin.  CMS Ex. 6 at 6, 25, 45.
Although CMS faults the facility for not calling Dr. Ramsey before sending R11 to the hospital, Dr. Ramsey insists that staff acted properly.  According to Dr. Ramsey, facility staff were not required to contact him before sending R11 to the hospital.  “I had a standing order . . . that directed nursing staff to either call me **or** send him to the ER if his glucose was still *less than 60 after 30 minutes*.”  P. Ex. 2 at 3 (Ramsey Decl. ¶ 10) (emphasis added).  This is consistent with the written order in R11’s medical record.  CMS Ex. 6 at 9.  Staff’s failing to call the physician did not put the facility out of
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substantial compliance; their failing to follow his orders – both his standing order and his telephone order – put the facility out of substantial compliance.
Curiously, LVN B filled out a telephone order form, dated September 21, that indicates she took a telephone order from R11’s physician directing that staff “may send” R11 to the emergency room.  CMS Ex. 6 at 5.  The problem with this is that LVN B never spoke to Dr. Ramsey.  By his own testimony, he gave no such order at that time; his *standing order* authorized staff to send the resident to the emergency room.  P. Ex. 2 at 3 (Ramsey Decl. ¶ 10).
R11 was admitted to the hospital and remained in intensive care until September 23.  CMS Ex. 6 at 24, 56; CMS Ex. 12 at 3 (Brown Decl. ¶ 6C).
**The facility’s substantial noncompliance:  medication errors (42 C.F.R. § 483.45(f)(2))**.  Petitioner identifies, as a “genuine issue of material fact,” whether a medication error actually occurred.  P. Response at 7.  In Petitioner’s view, because LVN A did not know definitively that she had made a medication error, the issue is in dispute.
I am puzzled as to why the facility couldn’t determine whether the nurse administered the wrong medication.  Medications are (supposed to be) measured carefully, and the dosages administered are recorded.  Presumably, based on the amounts remaining in the bottles, the facility should have been able to determine how much LVN A administered from each bottle.  *See, e.g.*, *Premier Living and Rehab Ctr.*, DAB No. 2146 at 5 (2008).
In any event, the evidence is substantial to overwhelming that LVN A dispensed the wrong insulin to R11.  The medication error report indicates that LVN A administered the wrong medication because she misread the physician order.  CMS Ex. 7 at 63.  In its disciplinary memorandum, facility management found “enough information and evidence to substantiate the allegation” that LVN A administered an insulin overdose; the memorandum concludes that she had “failed to recognize and appropriately deal with a medication error.”  P. Ex. 7 at 3.  The facility terminated her employment based on the apparent medication error.
Dr. Ramsey offers no alternative explanation for the precipitous drop in R11’s blood sugar level.  P. Ex. 2 at 2 (Ramsey Decl. ¶ 5); P. Ex. 3; s*ee* CMS Ex. 6 at 11.
Nevertheless, Petitioner now suggests two alternative explanations:  First, notwithstanding its medication error report and disciplinary memorandum, the facility reported to the state agency that its investigation was “inconclusive” because R11 had blood sugar levels in the 100’s during the month of September.  CMS Ex. 7 at 5.  To the extent that the facility wanted to create the impression that very low blood sugar levels were not unusual for R11, its representation is misleading, particularly considering R11’s 6:00 p.m. levels.  At that hour, his levels ranged from the mid-to-high 100’s to the low
Page 26
300’s.  The lowest level recorded at 6:00 p.m. is 125 and the highest is 316.  There is obviously a big difference between 78 and 125.  Moreover, R11’s blood sugar levels never fell into the 70’s (or even 80’s) at any time of day.  CMS Ex. 6 at 75.  The undisputed evidence establishes that, for R11, the blood sugar levels he experienced on the night of September 20 were unprecedented.
Second, Petitioner suggests that R11 may have self-administered the medication in a suicide attempt.  P. Response at 8.  The evidence for this is so weak that it does not create even a “metaphysical doubt.”  A social service progress note indicates that the hospital called the facility to report that R11 had a “history” of insulin overdose.  The record does not indicate when this may have occurred, although nothing suggests that it was recent.  Following the facility’s suicide prevention protocol, staff searched his room and found no insulin vial or anything else to suggest that he had self-administered insulin.  CMS Ex. 6 at 51.  Nothing in R11’s medical records suggests that this was even a possibility.  The facility had not identified him as a suicide risk.  He was not actively depressed or contemplating suicide.  *See, e.g.*, CMS Ex. 6 at 45 (describing R11 as “pleasant,” with no complaints other than the insulin problem); CMS Ex. 6 at 53 (denying depression or stress); CMS Ex. 7 at 4 (describing R11 as alert, watching TV, and “having no issues”).  Moreover, no evidence indicates that, on his own, he would have been able to obtain insulin; in fact, the evidence establishes that he did not.  CMS Ex. 6 at 51.  Based on this evidence, no rational trier of fact could conclude that R11 self-administered the extra insulin.
Notwithstanding the strong probability that LVN A mistakenly gave R11 the concentrated insulin, for purposes of summary judgment, I will assume that question is unresolved, and infer that the LVN did not administer the wrong medication.  The question is not material.  The regulation requires that the facility *ensure* that residents are free of significant medication errors.  42 C.F.R. § 483.45(f)(2).  The facility’s dangerous practice of keeping together, on the medication cart, the U500 insulin and the regular insulin, by itself, puts the facility out of substantial compliance with section 483.45(f), particularly since Dr. Ramsey had repeatedly warned them not to do it.
Further, failing to record and transcribe – promptly and accurately – a physician’s order also means that that the facility was not ensuring that its residents would be free of medication errors.
I therefore conclude that the facility’s practices violated section 483.45(f).  But even if I were not able to reach that conclusion, the facility’s remaining deficiencies more than justify the penalties imposed.  *Perry Cty. Nursing Ctr., v. U.S. Dep’t. of Health & Human Servs.*, 603 F. App’x. 265, 271 (5th Cir. 2015) (agreeing that the regulations require ALJs to review only those findings that are material to the outcome of a case); *Claiborne-Hughes Health Ctr. v. Sebelius*, 609 F. 3d 839, 847 (6th Cir. 2010); *Rockcastle Health*
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*and Rehab. Ctr.*, DAB No. 2891 (2018); *Carrington Place of Muscane*, DAB No. 2321 at 20-21 (2010).
**The facility’s substantial noncompliance:  quality of life/quality of care (42 C.F.R. §§ 483.24, 483.25) and neglect (42 C.F.R. §§ 483.12(b), 483.95(c))**.  The undisputed evidence, including Dr. Ramsey’s statement, establishes that staff were supposed to check R11’s blood sugar every 15 minutes once it fell below 60; no evidence indicates that LVN A did so, and, by her own admission, LVN B checked it hourly.  If, after 30 minutes, R11’s blood sugar was still below 60, staff were to call his physician or send him to the emergency room.  R11’s blood sugar was well below 60 at least as early as 1:00 a.m.  But LVN B did not measure it again for an hour, by which time his blood sugar level had dropped even lower.  She did not call the EMTs until after 2:30 a.m.  By the time staff sent R11 to the hospital, his blood sugar levels had been below 60 for at least an hour-and-a-half and potentially for as long as two to two-and-a-half hours.
Pointing to its witnesses’ written declarations, Petitioner asserts “there is a material issue of fact as to whether Petitioner failed to provide necessary care and services to [R11] and failed to follow physician’s orders[,] in violation of the regulatory requirements.”  P. Response at 10.  Petitioner also asserts that “genuine issues of material fact exist with regard to whether the failure to transcribe [R11’s] physician order on September 20, 2017, constitutes neglect and a failure to provide services in violation of [the neglect and quality of life/quality of care regulations].”  P. Response at 10-11.
These are not questions of fact; they are conclusions of law, which do not preclude my issuing summary judgment.  *West Texas LTC Partners, Inc.*, DAB No. 2652 at 6-7, 14-15; *Bartley Healthcare Nursing and Rehab.*, DAB No. 2539 at 8 (holding that summary judgment is not inappropriate merely because the parties proffer differing opinions on the ultimate legal issue); *cf. Guardian Health Care Ctr.*, DAB No. 1943 at 11 (characterizing as “conclusory in nature” claims that the facility provided “effective,” “appropriate,” or “aggressive” interventions); *see Green Valley Health Care and Rehab. Ctr.*, DAB No. 2947 at 8 (2019) (quoting*Johnson v. Perez*, 823 F.3d, 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”)).
Nor am I required to accept a witness’s conclusory statements and unsupported speculation.  Neither Dr. Ramsey nor DON Cormier was at the facility on the night of September 20-21, and their knowledge of the care provided to R11 is necessarily limited.  A witness’s “unsupported speculation” does not create even a “metaphysical doubt,” much less raise a genuine dispute of material fact as required to preclude summary judgment.  *West Texas LTC Partners,* DAB No. 2652 at 15.  Further, where opinion testimony “is wholly at odds with what is shown unambiguously on the face of the [facility’s] documents,” it is not sufficient to raise a genuine dispute of fact precluding
Page 28
summary judgment; no rational trier of fact would be persuaded by expert testimony if it is contradicted by the facility’s documents on their face.  *Bartley*, DAB No. 2539 at 8.
Dr. Ramsey agrees that the nurses made multiple mistakes.  He also agrees that LVN A should have transcribed his verbal order to start the IV “as needed to maintain blood sugar.”  He points out that LVN B eventually transcribed his order, and claims that no harm was done.  P. Ex. 2 at 2 (Ramsey Decl. ¶ 8).  But the undisputed evidence (including Dr. Ramsey’s own declaration) shows that LVN B omitted critical instructions from her transcription.  She wrote:  “May start D5W 50 ml per hour to run overnight.”  CMS Ex. 6 at 5.  If this accurately reflects the sum total of Dr. Ramsey’s order, CMS is correct that LVN A should have started the IV when the order was given.  But Dr. Ramsey also claims that he directed LVN A to start the IV “if [R11’s] blood sugar continued to drop.”  P. Ex. 2 at 2 (Ramsey Decl. ¶ 7).  LVN B’s transcription does not reflect that important instruction.  And, the undisputed evidence establishes that neither nurse even attempted to start the IV until long after R11’s blood sugar had dropped to dangerous levels.
Further, by late afternoon on September 20, facility staff knew that LVN A may have neglected R11 by administering dangerous levels of insulin.  Yet, no one reported the allegation of neglect until 2:30 the following morning.
DON Cormier admits telling the surveyors that the nurses neglected R11 because they did not report immediately the medication error and the resident’s low blood sugar levels.  P. Ex. 6 at 2 (Cormier Decl. ¶ 10); *see* CMS Ex. 10 at 12.  She claims now, however, that, although she personally wanted to be informed of resident status, facility policies did not require staff to notify her of a medication error or change in condition.  P. Ex. 6 at 2 (Cormier Decl. ¶ 10).  The DON’s mischaracterization of the facility’s policy suggests that she has not been properly trained.  Moreover, she does not create a potential dispute of fact that requires an in-person hearing because her assertion is belied by the documents themselves.  *Bartley*, DAB No. 2539 at 8.  The facility policy requires that all *allegations* of neglect be reported immediately, and not later than two hours after the allegation is made.  CMS Ex. 8 at 9, 12.  The policy specifically lists, as an example of neglect, failing to give a resident medications as prescribed.  It also requires that staff document “diligent[ly]” the physician orders.  CMS Ex. 7 at 96.
Moreover, DON Cormier does not comment on other failings:  the facility’s dodgy practice of placing the two insulin bottles next to each other on the medication cart; LVN A’s failing to transcribe the physician order; the lengthy delay between when the physician issued his orders and when they were (mis)transcribed; and both nurses’ failing to monitor R11’s blood sugar levels every 15 minutes, as required by his physician order.
Because Petitioner has not come forward with evidence suggesting a dispute over any of these facts, they are undisputed.  Based on these multiple failings, R11 was neglected.
Page 29
He did not receive the goods, services, and treatment he needed to avoid physical harm and emotional distress, and to maintain his highest practicable physical, mental, and psychosocial well-being.  The facility was therefore not in substantial compliance with sections 483.12(b), 483.95(c), 483.24, 483.25, and 483.45(f).
***5.  The undisputed evidence establishes that CMS’s determination that the facility’s deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.***
**Immediate jeopardy**.  Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *Barbourville Nursing Home*, DAB No. 1931 at 27-28 (2004) (citing*Koester Pavilion*, DAB No. 1750 (2000)); *Daughters of Miriam Ctr.*, DAB No. 2067 at 7, 9 (2007).
Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS’s determination is clearly erroneous.  *Grace Healthcare of Benton*, DAB No. 2189 at 13 (2008) (citing *Liberty Commons Nursing & Rehab Ctr.- Johnston*, DAB No. 2031 at 17-18, *aff’d* *sub nom.* *Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007)).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.’”  *Maysville Nursing and Rehab.*, DAB No. 2874 at 21 (2018) (quoting *Libertywood Nursing Ctr*., DAB No. 2433 at 18 (2011), *aff’d sub nom. Libertywood Nursing Ctr. v. Sebelius*, 512 Fed. App’x 285 (4th Cir. 2013)).
The undisputed evidence establishes that R11 was seriously ill throughout the evening and early-morning hours of September 20.  The LVNs’ haphazard monitoring of his blood sugar levels and delays in getting him the treatment he needed not only prolonged his distress, it jeopardized his health and possibly his life.  His blood sugar level dropped to 49 before the EMTs provided him the care he so desperately needed.  He ended up in the emergency room and the hospital’s intensive care unit.  It seems hard to argue that this situation did not pose immediate jeopardy.
Yet Petitioner argues just that.  Petitioner acknowledges that R11 “may have felt like crap,” but claims that his condition was not sufficiently serious, and the potential harm
Page 30
was not sufficiently immediate to constitute immediate jeopardy.  The EMTs were able to start an IV, and his blood sugar levels improved.  He was moved to the ICU for monitoring and did not require any type of special care or services.  P. Response at 14.  In Petitioner’s view, because the facility conditions did not present a “crisis situation,” it did not pose immediate jeopardy.  P. Response at 15-16.
The Departmental Appeals Board has soundly rejected the notion that immediate jeopardy requires a “crisis situation.”  *Mississippi Care Ctr. of Greenville*, DAB No. 2450 at 16 (2012).  Nor must the potential harm be imminent.  A facility’s deficiencies may pose immediate jeopardy even though the harm is not likely to occur in the near future.  *Agape Rehab. of Rock Hill*, DAB No. 2411 at 19; *Barbourville Nursing Home*, DAB No. 1962 at 16-18 (2005) (finding that a facility’s failing to track information in accordance with its policies posed immediate jeopardy, even though no harm had resulted, and potential harm would not happen “in hours or days, but over weeks or months.”).
Moreover, in a case involving an insulin overdose, the Board specifically rejected arguments that were almost identical to those Petitioner poses here.  *Hallmark House Nursing Ctr*., DAB No. 2226 (2009).  There, the facility argued that its resident was not harmed by an overdose of the insulin drug, Lantus, because any injury she suffered was reversible; she was awake and lucid; and, within one hour of discovery, her blood sugar level was normal.  Her physician and the facility administrator each opined that she did not suffer any harm.  Citing medical sources, the Board noted that the drug can remain in effect for up to 24 hours after it is administered and that an overdose may lead to severe and sometimes long-term and life-threatening hypoglycemia.  Severe episodes include coma, seizure, or neurologic impairment, that may be treated with intramuscular/subcutaneous glucagon or (as here) concentrated intravenous glucose.  Even after apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrates may be necessary to avoid recurrence.  *Hallmark*, DAB No. 2226 at 6-7.
The Board also rejected the facility’s argument that immediate jeopardy requires permanent or irreversible injury or harm, and concluded that the physician’s orders to administer intramuscular glucagon and send the resident to the emergency room; the nurse’s 911 call; and the resident’s subsequent hospitalization demonstrate that the overdose “required extraordinary care, close monitoring, and intervention as needed during the 24-hour period in which the medication was in effect.”  *Id* at 9.
The facility’s deficiencies in administering insulin and its treatment of R11 when he experienced severe hypoglycemia were likely to cause – and, in fact, did cause – serious harm.  CMS’s determination that those deficiencies posed immediate jeopardy to resident health and safety is therefore not clearly erroneous.
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***6.  The undisputed evidence establishes that the penalties imposed are reasonable.***
To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.
I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1638 at 8 (1999).
Petitioner complains about CMS’s decision-making process, arguing, for example, that “there is no evidence that CMS considered the facility’s financial condition.”  P. Br. at 15; P. Response at 16.  The Board has long rejected such attacks, explaining that the purpose of these proceedings “is not to determine whether CMS followed the correct procedure in determining to impose or setting the amount of the CMP.”  Rather, I resolve the issues before me – including the question of the penalty amounts – *de novo*, based on the evidence before me.  *Emerald Oaks*, DAB No. 1800 at 9 (2001); *accord* *Cmty. Nursing Home*, DAB No. 1807 at 22.11
Here, CMS imposes penalties of $12,249 per day for one day of immediate jeopardy, which is in the low to mid-range ($6,394 to $20,965), and $3,760 per day for 22 days of substantial noncompliance that did not pose immediate jeopardy, which is in the mid to higher-range ($105 to $6,289).  42 C.F.R. §§ 488.408(d); 488.438; 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).12
Page 32
Applying the relevant factors here, these penalties are reasonable.
The facility has a less than stellar history with respect to both the LSC and health care requirements, including several (dietary, pharmacy, and quality of care) that were found during the September 2017 surveys.
The September 2014 annual LSC survey cited two deficiencies (Tags K281 and K914) at scope and severity level F.  They involved problems with the illumination of exits and maintenance of electrical systems.  CMS Ex. 19 at 2.  The September 2016 LSC survey found related problems:  two deficiencies (Tags K291 and K293) involved emergency lighting and exit signage and were cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm).  A third deficiency (Tag K351), cited at scope and severity level F, addressed installation of sprinkler systems.
Deficiencies found during the prior annual health surveys are even more disturbing because some of them were the same or very similar to those cited during the September 2017 surveys.  The September 2014 survey cited multiple deficiencies:13
42 C.F.R. § 483.25(a)(3) (Tag F312) (quality of care – activities of daily living) cited at scope and severity level E;
	42 C.F.R. § 483.25(h) (Tag F323) (quality of care – accident prevention) cited at scope and severity level E;
	42 C.F.R. § 483.25(m)(1) (Tag F332) (quality of care – medication error rates) cited at scope and severity level E;
	**42 C.F.R. § 483.35(i) (Tag F371) (dietary services – food safety) cited at scope and severity level F**;14
	42 C.F.R. § 483.60(a) and (b) (Tag F425) (pharmacy services – procedures and consultation) cited at scope and severity level F;Page 33
42 C.F.R. § 483.65 (Tag F441) (infection control) cited at scope and severity level F;
	42 C.F.R. § 483.70(h)(4) (Tag F469) (physical environment – pest control) cited at scope and severity level F; and
	42 C.F.R. § 483.75(d)(1)-(2) (Tag F493) (administration – governing body) cited at scope and severity level F.The September 2015 survey also found multiple instances of substantial noncompliance:
42 C.F.R. §§ 483.10(b)(3) and 483.10(d)(2) (Tag F154) (resident rights – notice of rights and services) cited at scope and severity level E;
	42 C.F.R. § 483.15(a) (Tag F241) (quality of life – dignity) cited at scope and severity level E;
	42 C.F.R. § 483.15(f)(1) (Tag F248) (quality of life – activities) cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
	**42 C.F.R. § 483.25 (Tag F309) (quality of care) cited at scope and severity level E**;
	**42 C.F.R. § 483.35(i) (Tag F371) (dietary services – food safety) cited at scope and severity level F**;
	**42 C.F.R. § 483.60 (b),(d), and (e) (Tag F431) (pharmacy services – storage of drugs and biologicals) cited at scope and severity level F**; and
	42 C.F.R. § 483.70(h)(4) (Tag F469) (physical environment – pest control) cited at scope and severity level F.CMS Ex. 19 at 1.
The facility’s September 2016 health survey again found substantial noncompliance with multiple requirements:
**42 C.F.R. § 483.35(i) (Tag F371) (dietary services – food safety) cited at scope and severity level F**;Page 34
42 C.F.R. § 483.60(a) and (b) (Tag F425) (pharmacy services – procedures and consultation) cited at scope and severity level E;
	**42 C.F.R. § 483.60 (b),(d), and (e) (Tag F431) (pharmacy services – storage of drugs and biologicals) cited at scope and severity level E**;
	42 C.F.R. § 483.70(h)(4) (Tag F469) (physical environment – pest control) cited at scope and severity level F; and
	42 C.F.R. § 483.75 (Tag F498) (administration – nurse aide proficiency) cited at scope and severity level E.CMS Ex. 19 at 1.
The facility’s history – particularly with respect to those deficiencies that were again cited during the September 2017 surveys – justifies penalties that are significantly higher than the minimums.
With respect to its financial condition, Petitioner complains that neither CMS nor Nurse Consultant McElroy, RN, address the facility’s financial condition.  But CMS is not required to produce any evidence as to the facility’s financial condition.  *Cmty. Nursing Home*, DAB No. 1807 at 22; *Emerald Oaks*, DAB No. 1800.  The *facility* has the burden of demonstrating that paying the CMPs would render it insolvent or would compromise the health and safety of its residents.  *Van Duyn Home & Hosp*., DAB No. 2368 (2011); *Gilman Care Ctr.*, DAB No. 2357 at 7 (2010).  Its claim must be supported by compelling financial documentation.  *Guardian Care Nursing & Rehab. Ctr.*, DAB No. 2260 (2009).  Here, Petitioner has produced no evidence regarding its financial condition.
With respect to the remaining factors, the facility’s problems go well beyond the blunders of two nurses.  The undisputed evidence shows that the facility effectively ignored repeated warnings of its vulnerabilities.  The earlier surveys put it on notice of problems with pharmacy, dietary, and quality of care.  More immediately, one of its nurses diverted narcotics.  Yet, the facility did not assure that its drugs were properly stored and disposed of.  The facility was warned that it was dangerous to keep two vastly different strengths of insulin side-by-side on the medication cart, yet it continued the practice.  There were systemic problems, for which the facility is culpable.
I have also discussed, in some detail, the multiple, serious mistakes made by both LVNs on the night of September 20-21.  LVN A failed to transcribe a physician telephone order, so neither nurse understood exactly what she was supposed to do.  Neither followed physician orders in multiple respects; and neither timely reported suspected neglect.  These were serious errors that jeopardized a resident’s health and safety.  For these reasons, I find that the amounts of the CMPs are reasonable.
Page 35
Conclusion
I find that the record is sufficiently developed, and the only reasonable conclusion that can be drawn from the undisputed facts is that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  Based on the undisputed evidence, I also find that the penalties imposed – $12,249 per day for one day of immediate jeopardy and $3,760 per day for 22 days of substantial noncompliance that did not pose immediate jeopardy – are reasonable.  I therefore grant CMS’s motion for summary judgment.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1.  The regulations governing long-term care facilities were revised shortly before the surveys here.  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017).  However, the substance of the regulations (much of which is also statutory) has not changed. back to note 1
                      2. In error, CMS’s statement of deficiencies and notice letter cite this deficiency as 42 C.F.R. § 483.45(b)(2) and (3), (g), and (h).  CMS Ex. 1 at 1; CMS Ex. 4 at 1.  The documents nevertheless accurately refer to the language of section 483.45(h)(1) and (2), and CMS corrected any confusion in its prehearing brief.  CMS Br. at 7 n.3. back to note 2
                      3. In error, CMS’s statement of deficiencies and notice letter cite this deficiency at 42 C.F.R. § 483.70(a).  CMS Ex. 1 at 1; CMS Ex. 3 at 3.  The documents accurately refer to the language of section 483.90(a), and CMS corrected the error in its prehearing brief.  CMS Br. at 7 n.3. back to note 3
                      4. The surveyors cited two additional deficiencies:  42 C.F.R. § 483.21(b)(3)(i) (Tag F281) (resident assessments:  comprehensive care plans – professional standards of quality) and 42 C.F.R. § 483.70 (Tag F490) (administration).  CMS Ex. 1 at 1.  Following a state IDR (informal dispute resolution) proceeding, CMS agreed to delete those deficiencies.  CMS Ex. 1 at 17. back to note 4
                      5. The courts that have considered applying principles of summary judgment to Medicare administrative proceedings have carefully avoided any suggestion that deciding a case on summary judgment means that it is decided without a hearing.  Throughout their decisions, they refer to deciding the case without an “oral hearing” or without an “evidentiary hearing.”  Although a case may be decided on summary judgment (or based on the written record), an administrative law judge, by considering the evidence and applying the law, has granted the petitioner a hearing, as required by sections 205(b) and 1866(h) of the Act.  See CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”). back to note 5
                      6. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. back to note 6
                      7.  In fact, many of the facility’s policies are very poorly written and difficult to understand unless carefully parsed. back to note 7
                      8. The next two pages of the policy are found in the middle of CMS Ex. 7 (CMS Ex. 7 at 93-94. back to note 8
                      9. In making this assertion, Petitioner points to a chart, published by the Joslin Diabetes Center, that does not exactly support Petitioner’s claim. While the chart indicates that levels of 70 to 130 are considered normal, these are fasting levels, taken before meals or snacks. According to the chart, two hours after meals (as here), a normal level would be below 180; and, at bedtime, a normal level would be between 90 and 150. P. Ex. 1 at 1. back to note 9
                      10. No one has explained why LVN A was still there, and CMS has not pressed the issue.  See CMS Ex. 5 at 2; CMS Ex. 13 at 3; P. Ex. 7.  The facility’s administrator told Surveyor Brown that the drug diversion issue justified her termination.  CMS Ex. 10 at 14.  DON Cormier told Surveyor Brown that “between the drug diversion and [her] giving the wrong insulin,” LVN A was not “stable enough” to work safely with residents.  CMS Ex. 10 at 12.  The facility ultimately fired LVN A, not based on the drug diversion (for which she was eventually suspended), but based on her “possible medication error.”  P. Ex. 7 at 1, 3; P. Ex. 6 at 2 (Cormier Decl. ¶ 9). back to note 10
                      11. CMS presents the testimony of its nurse consultant, Daniel J. McElroy, RN, who explains the agency’s decision-making process.  CMS Ex. 18.  I find his testimony relevant solely as argument and opinion; not for explaining or defending the process itself. back to note 11
                      12. Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, on December 8, 2017.  See CMS Ex. 1 at 13; 82 Fed. Reg. at 9182-83.  In arguing that CMS imposed a penalty in excess of the maximum allowed, Petitioner did not consider these changes.  P. Br. at 15. back to note 12
                      13. I cite the regulations that were in effect at the time of the 2014 survey.  As noted above, the actual requirements have remained the same, and, although the regulatory citations may have changed, the tag number for any particular requirement has not. back to note 13
                      14. I highlight, in bold, the deficiencies that were repeated in the September 2017 surveys. back to note 14 Back to top
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