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                              Windsor Nursing & Retirement Home, DAB CR5208 (2018)
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Windsor Nursing & Retirement Home, DAB CR5208 (2018)








  
  
    

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





Windsor Nursing & Retirement Home,
	(CCN:  22-5349),
	Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-16-888Decision No. CR5208November 9, 2018

        
              
    

      DECISION
For at least a year, Windsor Nursing & Retirement Home (Petitioner or facility) failed to conduct code blue drills to ensure its staff was familiar with and prepared to implement its code blue policy during a medical emergency, despite that very policy requiring it to conduct such drills “routinely.” During a live code blue emergency involving a resident who suddenly lapsed into unconsciousness and experienced trouble breathing, Petitioner’s staff failed to follow numerous code blue procedures. Ultimately, the resident went into cardiac arrest and died. Petitioner now challenges the determination of the Centers for Medicare & Medicaid Services (CMS) that Petitioner’s actions with respect to this resident constituted noncompliance with multiple Medicare participation requirements and posed immediate jeopardy to resident health and safety. Petitioner further challenges the civil money penalties (CMPs) that CMS imposed based in large part on this alleged noncompliance.
We may never know if the resident would have survived had Petitioner properly prepared its staff to deal with his medical emergency. Nonetheless, for the reasons that follow, I conclude that summary judgment is appropriate in this case because the evidence, even viewed in the light most favorable to Petitioner, establishes that: (1) Petitioner did not substantially comply with the Medicare participation requirements at 42 C.F.R. §§ 483.10(b)(4), (8); 483.20(k)(3)(i); 483.20(k)(3)(ii); 483.25; and 483.25(k) from May 27 through June 28, 2016; (2) CMS did not clearly err in determining that Petitioner’s
**Page 2**
noncompliance with §§ 483.20(k)(3)(i) and 483.25 posed immediate jeopardy to the health and safety of Petitioner’s residents from May 27 through June 7, 2016; and (3) the imposed CMPs are reasonable in amount and duration. I therefore grant CMS’s motion for summary judgment.
I. Background and Procedural History
Petitioner is a skilled nursing facility (SNF) located in South Yarmouth, Massachusetts. Petitioner’s Exhibit (P. Ex.) 1 at 1. Surveyors from the Massachusetts Department of Public Health, Bureau of Health Care Safety and Quality, Division of Health Care Quality (state agency) surveyed Petitioner’s facility from May 24 through May 27, 2016. CMS Ex. 1 at 1; CMS Ex. 2 at 1. The state agency found that the facility was not in substantial compliance with Medicare program participation requirements and that the conditions constituted immediate jeopardy. CMS Ex. 2 at 1-16. Based on the survey findings, CMS determined that the facility was not in substantial compliance with the requirements found at 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25 (Tags F281 and F309) and that Petitioner’s noncompliance with these requirements posed immediate jeopardy to the health and safety of Petitioner’s residents beginning on May 27, 2016. CMS Ex. 1 at 1-2. Following a revisit and extended survey completed June 9, 2016, the state agency found that Petitioner had removed the immediate jeopardy conditions but was not in substantial compliance with additional program requirements. CMS Ex. 1 at 7; CMS Ex. 2 at 17-46. Following a second revisit survey completed July 6, 2016, the state agency found that Petitioner had corrected the remaining noncompliance as of June 29, 2016. CMS Ex. 1 at 12-13. Based on the revisit survey findings, CMS determined that the facility’s immediate jeopardy noncompliance lasted through June 7, 2016, and that the facility remained out of substantial compliance through June 28, 2016, with the requirements found at 42 C.F.R. §§ 483.10(b)(4) (Tag F155), 483.20(k)(3)(ii) (Tag F282), and 483.25(k) (Tag F328). CMS Ex. 1 at 7, 12, 19. CMS imposed a CMP of $7,350 per day effective May 27 through June 7, 2016, and a CMP of $1,650 per day effective June 8 through June 28, 2016. CMS Ex. 1; P. Exs. 7, 8. CMS also advised Petitioner that it was ineligible to conduct a nurse aide training and competency program (NATCEP) for two years effective May 27, 2016 through May 26, 2018.1
 CMS Ex. 1 at 4.
**Page 3**
Petitioner filed two separate hearing requests: the first on August 5, 2016, the second on September 12, 2016. On August 10, 2016, I issued an acknowledgment and pre-hearing order establishing a briefing schedule. On September 19, 2016, I issued an order consolidating Petitioner’s hearing requests for hearing and decision. In accordance with the schedule I set, CMS filed a prehearing exchange, including a combined prehearing brief and motion for summary judgment (CMS Br.), exhibit list, and 13 proposed exhibits (CMS Exs. 1-13). Petitioner also timely filed its prehearing exchange, including a combined prehearing brief and opposition to CMS’s motion for summary judgment (P. Br.), exhibit and witness lists, and 10 proposed exhibits (P. Exs. 1-10). CMS later filed a reply to Petitioner’s opposition.2
 As neither party has objected to any of the proposed exhibits, I admit all of them into the record.
II. Issues
The issues in this case are:
Whether summary judgment is appropriate;
		Whether Petitioner failed to comply substantially with Medicare participation requirements;
		If Petitioner did not comply substantially with Medicare participation requirements, then whether CMS’s immediate jeopardy determination was clearly erroneous; and
		Whether the remedy imposed is reasonable.
III. Jurisdiction
I have jurisdiction to hear and decide this case. Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).
**Page 4**
IV. Discussion
**A. Statutory and Regulatory Framework**
The Social Security Act sets requirements for SNF participation in the Medicare program. The Act authorizes the Secretary of the U.S. Department of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). The Secretary’s regulations are found at 42 C.F.R. parts 483 and 488.
A facility must maintain substantial compliance with program requirements in order to participate in the program. To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.” 42 C.F.R. § 488.301. A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. *Id.* “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” *Id.*
The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20. The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The regulations specify the enforcement remedies that CMS may impose. 42 C.F.R. § 488.406. Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a SNF is not in substantial compliance. 42 C.F.R. § 488.430(a). A per-day CMP may range from either $50 to $3,000 per day for less serious noncompliance, or $3,050 to $10,000 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 42 C.F.R. § 488.438(a)(1).3
 “Immediate jeopardy” exists when “the provider’s
**Page 5**
noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.
**B. Findings of Fact, Conclusions of Law, and Analysis**
***1. Summary judgment is appropriate.4***
Summary judgment is appropriate if there is “no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.” *Mission Hosp. Reg’l Med. Ctr.*, DAB No. 2459 at 5 (2012) (citations omitted). In order to prevail on a motion for summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law. *Id.* If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a *genuine issue for trial* . . . .’” *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.*, 475 U.S. 574, 587 (1986) (emphasis in original). “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact — a fact that, if proven, would affect the outcome of the case under governing law.” *Senior Rehab. & Skilled Nursing Ctr.*, DAB No. 2300 at 3 (2010).
In evaluating a motion for summary judgment, an administrative law judge does not address credibility or evaluate the weight of conflicting evidence. *Holy Cross Village at Notre Dame, Inc.*, DAB No. 2291 at 5 (2009). Rather, in examining the evidence to determine the appropriateness of summary judgment, an administrative law judge must draw all reasonable inferences in favor of the non-moving party. *See Brightview Care Ctr.*, DAB No. 2132 at 10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable). “[A]t the summary judgment stage the judge’s function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” *Anderson v. Liberty Lobby, Inc*., 477 U.S. 242, 249 (1986). However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions. *Cedar Lake Nursing Home*, DAB No. 2344 at 7 (2010).
Here, there is no genuine dispute of material fact. The parties’ arguments center not on what the facts are, but rather on the legal significance of those facts. Insofar as Petitioner attempts to raise factual disputes in its brief opposing summary judgment, my analysis in section IV.B.2-4, *infra*, shows that those disputes are not material to the issues I must decide. Consequently, I conclude that summary judgment is appropriate in this case.
**Page 6**
***2.**Petitioner was not in substantial compliance with Medicare participation requirements.***
***a.**Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.20(k)(3)(i) (Tag F281); 483.25 (Tag F309); and 483.10(b)(4), (8) (Tag F155) because it failed to follow its code blue policy and procedures when providing care to Resident 5 while he was experiencing a medical emergency.***
The care and services provided by a facility must meet professional standards of quality. 42 C.F.R. § 483.20(k)(3)(i). The quality of care regulation states that “[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.” 42 C.F.R. § 483.25. Appellate panels of the Departmental Appeals Board (DAB) have held that this quality of care requirement “also ‘implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality . . . .’” *Lakeridge Villa Healthcare Ctr.*, DAB No. 2396 at 7-8 (2011) (quoting *Sheridan Health Care Ctr.*, DAB No. 2178 at 15 (2008)). Appellate panels of the DAB also have held that “it is ‘reasonable to presume’ that [a facility’s own] policies reflect professional standards of quality.” *Perry Cnty. Nursing Ctr.*, DAB No. 2555 at 9 (2014) (quoting *Sheridan Health*, DAB No. 2178 at 32).
SNF residents have the right “to formulate an advance directive,” and SNFs “must maintain written policies and procedures concerning advance directives” including “a written description of the facility’s policies to implement advance directives . . . .” 42 C.F.R. §§ 483.10(b)(4), (8); 489.102(a). An advance directive is “a written instruction, such as a living will or durable power of attorney for health care, recognized under State law . . . , relating to the provision of health care when the individual is incapacitated.” 42 C.F.R. § 489.100. To maintain compliance with the regulation (Tag 155), SNFs must, among other things, “implement[] policies and procedures regarding the right to formulate advance directives” and “monitor[] the care and services given to [a] resident to ensure that they are consistent with the resident’s documented choices and goals.” State Operations Manual (SOM), CMS Pub. 100-07, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (Rev. 133, effective 02-06-2015).5
CMS concluded that Petitioner failed to comply substantially with these three requirements (Tags F281, F309, and F155) based on Petitioner’s response to a medical
**Page 7**
emergency involving Resident 5.6
 In CMS’s view, Petitioner’s emergency response did not meet the professional standards of care established by Petitioner’s own policies regarding medical emergencies and advance directives. As a result, CMS found, Petitioner failed to provide Resident 5 with the services he needed to attain or maintain his highest practicable level of well-being. CMS Br. at 13-23. Therefore, I address these three allegations of noncompliance together.
The documents in the record, particularly Petitioner’s own written policies and notes from Petitioner’s investigation into the medical emergency involving Resident 5, which Petitioner created and maintained, establish the following facts, which I find to be undisputed.
*Code Blue Policy*: At all times during the events at issue, Petitioner maintained a policy entitled “Emergency / Code Blue Response.” CMS Ex. 10. Petitioner’s core policy for responding to medical emergencies was “to provide timely intervention” during an emergency. *Id.* at 1. The stated purpose of this policy was “[t]o provide [the] individual with timely and appropriate staff intervention in the case of a medical emergency.” *Id.* To achieve the stated purpose, the policy described nine procedures (designated A through I) that Petitioner’s staff members were required to implement if they “observe[d] an individual experiencing a medical emergency.” The Code Blue Response included the following items, among others:
A. The staff member that finds the victim in distress will:
1. Call loudly “**CODE BLUE**” to signal for help; and
2. Activate the call bell system if the system can be reached.
* * *
B. The staff member who responds to the call for help will be responsible for:
* * *
2. Overhead paging “**CODE BLUE**” and **Location of the Emergency**three (3) times.
C. The ***FIRST*** Nursing Supervisor or Charge Nurse responding to the emergency will coordinate care for the victim to include acting as the **Code Leader**/AED co‐coordinator. They will immediately:
* * *
**Page 8**
6. Designate a staff member (if response from emergency medical system needed) to go to the front door to meet the emergency responding team.
a. Staff member will bring the first responders to the location of the emergency.
D. The Code Leader should designate another staff member to copy and/or complete:
1. Page 1 & 2 of the transfer referral
2. The resident’s face sheet
3. The most recent MAR [Medication Administration Record]
E. The Code Leader will be responsible for assigning nurse to document on Code Blue Flow Sheet during Code.
* * *
H. Code Blue drills will be conducted routinely with results reported to the Safety Committee.
I. Staff responding to a “Code Blue” will be:
7-3 shift  All staff on the unit the victim is found, Director of Nurses,   Assistant Director of Nurses, all the Nurse Managers
* * *
The Code Leader is responsible for delegating responsibilities to staff responding to “Code Blue”
CMS Ex. 10 at 1-2 (emphasis in original).
*Advance Directives Policy*: At all times during the events at issue, Petitioner also maintained a policy entitled “Advance Directives / Do Not Resuscitate Orders.” CMS Ex. 13 at 1-3. Petitioner’s core policy related to advance directives was “[t]o respect each . . . resident’s right to participate in and/or make his/her treatment decisions.” CMS Ex. 13 at 1. Petitioner’s advance directives policy stated, among other things, that, “[w]hen appropriate, the facility makes every attempt to implement, with the resident and/or resident’s family, the health care directives set forth previously in the resident’s Advance Directive.” *Id.*
**Page 9**
*Resident 5*: Resident 5 was a 54-year-old man admitted to the facility on February 24, 2016, after an extended hospital stay “due to sepsis, metabolic encephalopathy, respiratory failure and eventual renal failure . . . .” P. Ex. 4 at 1, 8, 16; *see also*CMS Ex. 5 at 4. In addition to these conditions, Resident 5 had a lengthy list of current and historical diagnoses including, but not limited to, coronary artery disease, atrial fibrillation, peripheral vascular disease, chronic congestive heart failure, chronic angina, osteomyelitis, gangrene, type II diabetes, anemia of renal disease. CMS Ex. 5 at 4-5; P. Ex. 4 at 1, 8-9, 16. Resident 5’s medical record clearly indicated the resident’s intent to be full code.7
 His wishes were documented in a physician’s order, Medical Order for Life-Sustaining Treatment, and signed consent form, stating that Resident 5 consented to attempts at resuscitation, intubation, ventilation, dialysis, artificial nutrition, and artificial hydration, if necessary. CMS Ex. 13 at 6-9.
During his brief stay at the facility, Resident 5 received hemodialysis treatment for his renal failure as an outpatient at a local hospital. P. Ex. 4 at 1-2, 9, 16. He also received skilled occupational therapy throughout his stay. CMS Ex. 4 at 2. On March 1, 2016, Resident 5 underwent hemodialysis at the hospital and returned to the facility without incident. P. Ex. 4 at 1-2, 8-9, 16-17. Later that same day, Resident 5 was in Petitioner’s rehabilitation gym receiving skilled occupational therapy. CMS Ex. 4 at 2. At about 1:50 p.m., while Resident 5 “was engaged in light exercise” his arm twitched, his eyes rolled back, his breathing became erratic, and he became unconscious and unresponsive. CMS Ex. 4 at 1-3; P. Ex. 5 at 1, 7; P. Ex. 6 at 12, 14, 17, 20, 26. His respiratory rate was eight breaths per minute at first, dropping to four breaths per minute thereafter. CMS Ex. 5 at 12.
The first responders to Resident 5’s developing medical emergency were members of Petitioner’s physical and occupational therapy staff. Louis Arruda was the certified occupational therapy assistant (COTA) working with Resident 5 at the time he lost consciousness. Also present in the rehabilitation gym was Cecily Conway, a physical therapy assistant (PTA). Nora Finn, a physical therapist (PT) and Petitioner’s rehabilitation manager, was at her desk in a room adjacent to the rehabilitation gym with her door open. P. Ex. 5 at 1-3; P. Ex. 6 at 9, 24, 26-27. In response to Resident 5’s emergency, COTA Arruda stayed with Resident 5 while PTA Conway called 9-1-1 and PT Finn called for assistance from other staff. P. Ex. 5 at 1, 3; P. Ex. 6 at 9, 24, 27. None of these individuals called out code blue, activated the facility’s call bell system, or paged code blue on the intercom. P. Ex. 4 at 12; P. Ex. 5 at 6; P. Ex. 6 at 7, 9, 12, 17; P. Br. at 15-16. PTA Conway was unable to use the facility’s phone to dial 9-1-1, so she called on her cell phone. P. Ex. 5 at 1; P. Ex. 6 at 9. PT Finn telephoned Jen Carroll, a
**Page 10**
licensed practical nurse (LPN) unit manager, telling her that Resident 5 did “not look right” and asking her to “come down here.” P. Ex. 5 at 3; P. Ex. 6 at 27. LPN Carroll “[g]rabbed Erica” McIsaac, a nurse practitioner (NP), and the two of them made their way down to the rehab gym. P. Ex. 5 at 7-8; P. Ex. 6 at 15, 17, 19-20.
On her way down to the rehab gym, LPN Carroll ran into Angie Pfeifer, Petitioner’s director of nursing services (DON), and told her Resident 5 was not doing well in the rehab gym. P. Ex. 5 at 5; P. Ex. 6 at 6. DON Pfeifer “grabbed [the] crash cart” and accompanied LPN Carroll to the rehab gym. P. Ex. 5 at 5; P. Ex. 6 at 6. In the process of getting the crash cart, DON Pfeifer saw Alicia Kelly, a registered nurse (RN), and asked her “to go to [the] rehab gym.” P. Ex. 5 at 4. After arriving at the rehab gym, RN Kelly called Don Landers, Petitioner’s director of environmental services, and a man named Jared to help lift Resident 5 from his wheelchair. P. Ex. 5 at 4; P. Ex. 6 at 1. Together, DON Pfeifer, COTA Arruda, Mr. Landers, and Jared lifted Resident 5 from his wheelchair and placed him supine on the rehab mat. P. Ex. 5 at 1, 5-6; P. Ex. 6 at 1, 6, 9, 24.
While Resident 5’s medical emergency was unfolding, no single individual assumed responsibility for leading the code and the nurses involved were unsure who was in charge. RN Kelly thought she was in charge; NP McIsaac thought that RN Kelly was in charge; LPN Carroll thought that there was no one person in charge but also indicated that NP McIsaac took charge and that she was listening to NP McIsaac; DON Pfeifer and PTA Conway both believed no one was in charge; COTA Arruda thought DON Pfeifer may have been in charge. P. Ex. 4 at 12; P. Ex. 5 at 4, 6, 7; P. Ex. 6 at 2, 4, 5, 7, 9-10, 15-16, 17, 19, 20, 26. At no time during the code was anyone designated to copy and/or complete the transfer referral, Resident 5’s face sheet, or Resident 5’s MAR; rather, DON Pfeifer took it upon herself to “try[] to get paperwork for EMT’s [sic].” P. Ex. 5 at 5; *see also*P. Ex. 6 at 6-7. Nor was anyone designated to document on the code blue flow sheet what happened during the code; rather, the code blue flow sheet was filled out after the fact. P. Ex. 4 at 12-13; P. Ex. 5 at 4, 8; P. Ex. 6 at 18. The code blue flow sheet does not indicate when the AED (automatic external defibrillator) team, the “ERT [emergency response] Team,” or the AED arrived or when emergency medical services (EMS) were dispatched, nor does it indicate at what times Resident 5 became unresponsive or when rescue breathing started. CMS Ex. 4 at 5.
PTA Conway’s 9-1-1 call prompted a response by EMS, which dispatched an ambulance crew and fire engine to the facility. CMS Ex. 5 at 1, 14. When the ambulance arrived, the ambulance crew, consisting of one emergency medical technician (EMT) paramedic and two EMT basics, “were directed to the left of the entrance and various staff members in the area did not appear to be aware of what was going on or where [Resident 5] was located.” CMS Ex. 5 at 16. As the crew was “headed back towards the lobby area, they came upon a janitor who appeared upset, and he directed them to an area down in the basement and was the rehabilitation area.” *Id*. The fire engine crew reported similar
**Page 11**
difficulties, with one of the crew members reporting that “when they entered the facility, the staff members who greeted them were unsure of where exactly [Resident 5] was located.” *Id.* at 15. The crew member “walked down the stairs and eventually located the incident in the physical therapy room.” *Id*. Notwithstanding these problems, the ambulance crew documented that they arrived at the facility at 1:59 p.m. and also arrived at the patient at 1:59 p.m. *Id.* at 2. There is no indication in the reports of the incident that anyone was assigned to direct the EMTs to the rehab gym, and the EMTs’ reports show that no one accompanied them there after telling them where to go. *Id.* at 15-16.
Ultimately, Resident 5 went into cardiac arrest.8
 CMS Ex. 5 at 4, 9; P. Br. at 2. The EMTs took him to the emergency room by ambulance. CMS Ex. 5 at 4. When he arrived at the emergency room, “he was noted to have suspected ventricular fibrillation.” *Id*. His pulse returned when he was defibrillated. *Id*. Although he was resuscitated, “[h]e remained on the ventilator and on pressors [and] never responded to intensive therapy.” CMS Ex. 5 at 9. On March 6, 2016, after discussion with doctors at the hospital, Resident 5’s medical proxy changed Resident 5’s code status from full code to do not resuscitate and comfort measures only. *Id*. Shortly thereafter, Resident 5 died, five days after the initial emergency at the facility. *Id*.
When interviewed after the fact about the events surrounding Resident 5’s code situation, all staff members who were involved in Resident 5’s code were asked if they could recall the last time they had participated in a code blue drill. Their answers vary, but none of them could recall having done a drill in the past year. Some of them had never participated in a code blue drill while employed by Petitioner, while others recalled drills that had occurred years (as many as 15 years) prior to Resident 5’s code. P. Ex. 5 at 3, 4, 6-8; P. Ex. 6 at 1, 7, 10, 14, 15, 18, 22, 28; *see also* P. Ex. 4 at 8.
Petitioner does not dispute that its code blue response policy reflects professional standards of quality for responding to medical emergencies in its facility. Petitioner also does not dispute that its advance directive policy required it to “make[] every attempt to implement . . . the health care directives set forth previously in” Resident 5’s advance directive. CMS Ex. 13 at 1. It is beyond dispute that on March 1, 2016, at about 1:50 p.m., Resident 5 was experiencing a medical emergency while in Petitioner’s care, given that he was unconscious and having difficulty breathing. CMS Ex. 4 at 1-3; CMS Ex. 5 at 12; P. Ex. 5 at 1, 7; P. Ex. 6 at 12, 14, 17, 20, 26. Resident 5’s advance directive indicated he was full code, and he consented to attempts at resuscitation and other extraordinary measures. CMS Ex. 13 at 6-9. This meant he was entitled to all
**Page 12**
appropriate life-saving measures when he suddenly lost consciousness and showed signs of respiratory problems. P. Br. at 19; CMS Ex. 2 at 3, 19; CMS Br. at 2. Upon discovering that Resident 5 was experiencing a medical emergency, Petitioner was therefore duty-bound to make every attempt to implement Resident 5’s advance directive and provide Resident 5 with the care and services it had identified in its code blue policy as necessary to provide during a medical emergency. 42 C.F.R. §§ 483.10(b)(4), (8); 483.20(k)(3)(i); 483.25; *Perry Cnty.*, DAB No. 2555 at 9; *Lakeridge Villa*, DAB No. 2396 at 7-8.
It is beyond dispute, and Petitioner concedes, that Petitioner did not follow its code blue policy when providing care to Resident 5 during his medical emergency. P. Br. at 15, 17. Petitioner’s staff failed to follow no less than ten separate procedures found in Petitioner’s code blue policy.
Neither of the staff members who initially observed Resident 5 experiencing a medical emergency called out “code blue,” activated the call bell system, or paged code blue or the location of the emergency on the intercom, thereby violating procedures A.1, A.2, and B.2. CMS Ex. 10 at 1; P. Ex. 4 at 12; P. Ex. 5 at 6; P. Ex. 6 at 7, 9, 12, 17.
		No one took clear responsibility as code leader to coordinate care for Resident 5, as required by procedure C. CMS Ex. 10 at 1-2; P. Ex. 4 at 12; P. Ex. 5 at 4, 6, 7; P. Ex. 6 at 2, 4, 5, 7, 9-10, 15-16, 17, 19, 20, 26.
		No one designated a staff member to greet EMTs at the door and no one guided the EMTs to the scene of the emergency, as required by procedures C.6 and C.6.a. CMS Ex. 5 at 15-16; CMS Ex. 10 at 2; P. Ex. 6 at 14.
		No one designated a staff member to complete a transfer referral or to copy Resident 5’s face sheet or MAR, as required by procedure D. CMS Ex. 10 at 2; P. Ex. 5 at 2, 5; P. Ex. 6 at 6-7.
		No one assigned a nurse to document the events of the code on the code blue flow sheet while the code was ongoing, instead waiting until the code ended to incompletely document the events of the code, contrary to procedure E. CMS Ex. 4 at 5; CMS Ex. 10 at 2; P. Ex. 4 at 12-13; P. Ex. 5 at 4, 8; P. Ex. 6 at 18.
		No one actively sought out the director of nurses, assistant director of nurses, and all the nurse managers, even though they were listed in code procedure I as “[s]taff responding to a ‘Code Blue’” during the 7-3 shift.9
 CMS Ex. 10 at 2; P. Ex. 5 at 5; P. Ex. 6 at 6.
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Finally, Petitioner did not conduct code blue drills for at least a year prior to Resident 5’s emergency, violating procedure H. CMS Ex. 10 at 2; P. Ex. 4 at 8; P. Ex. 5 at 3, 4, 6-8; P. Ex. 6 at 1, 7, 10, 14, 15, 18, 22, 28.
In failing to follow its code blue policy and procedures, Petitioner also failed to make every attempt to implement Resident 5’s advance directive, thereby violating its advance directives policy. As noted, Resident 5’s advance directive indicated he was full code. CMS Ex. 13 at 9. In electing to be full code, Resident 5 was directing Petitioner to provide him with all appropriate life-saving measures during a medical emergency. *See*P. Br. at 19; CMS Br. at 2. Under Petitioner’s advance directives policy, Petitioner was required to make every attempt to implement this directive. CMS Ex. 13 at 1. To satisfy its duty to implement Resident 5’s wish to receive all appropriate life-saving measures when he experienced a medical emergency, Petitioner was required to provide Resident 5 the care and services Petitioner identified as necessary in its code blue policy. Providing him anything less than this level of care and services would fall short of making “every attempt” to implement Resident 5’s advance directive that he be given all appropriate life-saving measures. As already discussed in detail above, however, Petitioner did not provide Resident 5 with all the care and services identified in its code blue policy. Moreover, Petitioner did not monitor the care given to Resident 5 during his medical emergency as called for by its code blue policy and the SOM. SOM, CMS Pub. 100-07, Appendix PP.
In the explanation of the requirements of 42 C.F.R. § 483.10(b)(4), (8), the SOM notes that “[i]f a resident experiences a cardiac arrest . . . [p]rompt initiation of CPR is essential as brain death begins four to six minutes following cardiac arrest if CPR is not initiated within that time.” SOM, CMS Pub. 100-07, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (citing Laurie J. Morrison et al., *2010 Am. Heart Assoc. Guidelines for Cardiopulmonary Resuscitation & Emergency Cardiovascular Care*, Am. Heart Assoc., http://circ.ahajournals.org/content/122/18_suppl_3/S665 (last visited November 1, 2018)). Thus, any delay in providing the care and services necessary to treat a resident suffering from cardiac arrest could result in serious, irreversible harm or even death.
Given the numerous instances in which Petitioner failed to follow its code blue and advance directives policies, I conclude that the undisputed facts, even when viewed in the light most favorable to Petitioner, establish that Petitioner failed in its duty under 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25 to provide Resident 5 care and services that meet professional standards of quality and its duty under 42 C.F.R. § 483.10(b)(4), (8) to implement Resident 5’s advance directive. At a minimum, Petitioner’s failure to follow its code blue policy and honor Resident 5’s advance directive created the risk that its efforts to deliver needed treatment to Resident 5 during his medical emergency would be delayed.
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For example, failing to page code blue or the location of the emergency on the intercom could have delayed the EMTs’ arrival at the scene of the emergency if the staff who greeted the EMTs were unable to direct them to the scene because they didn’t know where the emergency was unfolding.10
 This risk of delay would be compounded if no one designated a staff member(s) to greet EMTs at the entrance and guide them to the emergency.11
 Having no clear code leader could create delays as well, given that the code leader was responsible for coordinating care for the resident and organizing the code response. Having no clear code leader meant no one was responsible for assigning staff to greet the EMTs and guide them to the emergency, which, as observed, could have delayed their arrival to the scene. In addition, having no clear code leader raised the possibility that staff could disagree about what care to provide in the situation, with no one to resolve any such disagreement, which had the potential to lead to paralysis or duplicated and wasted effort in the facility’s response to the emergency. Having no one assigned to gather the resident’s paperwork, including transfer papers, face sheet, and MAR, could delay the resident’s transfer to the hospital or other urgent care facility—another example of how lacking a code leader could cause delays. It also would increase unnecessarily the risk that the resident could be harmed by receiving incorrect types or amounts of medications other than those documented in his or her MAR. Having no one assigned to document the event while it was ongoing, while probably not causing a direct delay in the emergency response, could lead to inadequate documentation of any problems that occurred during the code response. Without adequate documentation of the problems (of which there were many in this case), the facility could fail to learn from and correct those problems to ensure staff followed the code blue policy going forward, which could contribute to delays in future emergencies. Not conducting code blue drills for over a year would decrease the likelihood that staff would be prepared to respond to a medical emergency smoothly and efficiently, without causing delays. As observed, any of these listed delays, or a combination thereof, could cause or contribute to more than minimal (indeed, potentially serious or even fatal) harm.
Petitioner argues that despite failing to follow its own code blue policy, it substantially complied with the regulations because it “acted reasonably in effectively implementing the Code Blue Policy all but in name” and did so “in a reasonable manner that effectuated the same results of the policy in a way that was at least as efficient.” P. Br. at 15, 17. Petitioner lists a series of actions that, in its view, were adequate to give Resident 5 care that was equivalent to the care called for in the code blue policy. P. Br. at 15-16. For
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example, Petitioner cites the relatively quick response by LPN Carroll, DON Pfeifer, NP McIsaac, and RN Kelly. P. Br. at 15-16. Petitioner also points out that the crash cart was brought to the scene quickly and that PTA Conway promptly called 9-1-1. P. Br. at 16. Petitioner also asserts that “[t]he staff members involved in the incident were confident that staff members outside of the rehabilitation gym . . . were aware of the incident, and capable of directing the EMS team to Resident 5’s location.” *Id*. Finally, Petitioner asserts, that staff “reviewed and carefully documented” the incident. *Id*. In summary, Petitioner offered the opinions of two witnesses who both conclude: “To the extent that [Petitioner’s] staff . . . did not follow its Code Blue Policy, I do not believe that any of the claimed deviations from the policy affected the outcome of the situation or the quality of care provided to Resident 5.” P. Ex. 1 at 4; P. Ex. 9 at 4.
The undisputed evidence shows, however, that only LPN Carroll was alerted intentionally; NP McIsaac happened to be nearby, so LPN Carroll “[g]rabbed” her, and LPN Carroll ran into DON Pfeifer, who in turn saw RN Kelly. P. Ex. 5 at 3-5, 7-8; P. Ex. 6 at 6, 15, 17, 19-20, 27. Thus, it was only by happenstance that anyone other than LPN Carroll was alerted to the emergency quickly. Had the other nurses been in their offices or in residents’ rooms providing care, they may not have responded quickly (or at all). This good fortune is also the only apparent reason that the crash cart was brought to the scene quickly, another circumstance Petitioner cites in its favor. P. Br. at 16. Had DON Pfeifer not been in a good location to be alerted, she might not have responded at all, much less brought the crash cart, and there is no indication that any other staff person thought to get the cart on the way to the scene. The call to 9-1-1, on which Petitioner also relies (P. Br. at 16), similarly proved problematic. PTA Conway was unable to call in the emergency on the facility’s phone and only managed to do so with her cell phone. P. Ex. 5 at 1; P. Ex. 6 at 9. Had she not been carrying her cell phone, she might have been further delayed in calling 9-1-1 for EMS response. DON Pfeifer did gather Resident 5’s paperwork, as Petitioner notes (P. Br. at 16), but this was of her own initiative, not the result of a code leader’s directive. P. Ex. 5 at 2, 5; P. Ex. 6 at 6-7. Further, contrary to the assumption of the staff members responding directly to Resident 5’s emergency, staff outside the rehab gym were not aware of the situation, as demonstrated by the undisputed evidence that the EMS team was greeted by staff who were unsure what was going on and were unable to direct the EMS team to the emergency. *See*P. Br. at 16. Finally, while it is undisputed, as Petitioner asserts, that staff “reviewed and carefully documented” the incident after the fact (P. Br. at 16), it is simply unreasonable to infer that after-the-fact documentation can make up for the requirement that staff document the incident while it was ongoing to ensure maximal accuracy of the documentation.
Even assuming for purposes of summary judgment that Petitioner’s numerous failures did not cause any delays during Resident 5’s medical emergency or that any delays that may have occurred did not affect the quality of the care he actually received, those failures still created a potential for more than minimal harm that existed throughout the
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emergency. Had Resident 5 suddenly experienced cardiac arrest at any point while still in Petitioner’s care,12
 Petitioner might not have implemented necessary interventions (e.g., CPR, EMS response, transfer to a hospital, etc.) timely as a result of its deficiencies, unnecessarily exposing Resident 5 to the risk that he might suffer brain death or other serious harm. Given that Petitioner’s failures created at least the risk of more than minimal harm to Resident 5, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.20(k)(3)(i), 483.25, and 483.10(b)(4), (8).
For purposes for summary judgment, I accept as true Petitioner’s representations and witness testimony, but they do not establish that Petitioner substantially complied with the cited regulations. The witness testimony, coupled with Petitioner’s listing of all the measures its staff took to ensure Resident 5 received timely intervention during his emergency in accordance with the code blue policy, may establish for purposes of summary judgment that Resident 5 was not actually harmed by Petitioner’s deficiencies during his actual medical emergency. However, a regulatory violation need not cause actual harm to rise to the level of noncompliance authorizing CMS to impose enforcement remedies, such as the CMPs imposed here. 42 C.F.R. §§ 488.301, 488.402(b), 488.438(a). Regardless of whether Petitioner’s deficiencies caused actual harm in Resident 5’s specific emergency, those deficiencies created a general risk of harm to Petitioner’s full code residents, including Resident 5. Petitioner’s manifest failure to implement its code blue policy and, by extension, its advance directives policy placed all of Petitioner’s full code residents at risk that, should they experience a medical emergency, they would not receive timely treatment during the emergency and thereby suffer (potentially serious and even life-threatening) harm, not because of the emergency itself, but because of Petitioner’s failures.
In sum, if (as I assume for summary judgment purposes) Resident 5 did not suffer any adverse consequences from Petitioner’s deficiencies, this was fortuitous at best. That by good fortune, Resident 5 escaped additional harm from Petitioner’s failure to follow its code blue policy does not undermine my ultimate conclusion that Petitioner’s deficiencies created a general risk for more than minimal harm to its residents’ health and safety.
Petitioner also argues that its failure to follow its code blue policy was “an isolated failure” that “does not conclusively establish” that it did not implement its code blue policy. P. Br. at 15, 18. Petitioner’s argument ignores its significant and numerous failures to follow its code blue policy. The sheer number of code blue procedures that Petitioner did not follow prior to and during Resident 5’s medical emergency, including
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the overarching failure to conduct any code blue drills for over a year, and perhaps even longer, demonstrate not an “isolated” but rather a systemic failure to implement the code blue policy. The fact that a single incident revealed Petitioner’s failure does not gainsay the systemic nature of that failure.
Specifically with respect to Petitioner’s noncompliance with 42 C.F.R. § 483.10(b)(4), (8), Petitioner asserts that “[t]he only claimed violation” of this requirement “is CMS’[s] assertion that [Petitioner] should have initiated CPR and used the AED on Resident 5.” P. Br. at 20. Framing the issue this way, Petitioner argues that it did not violate § 483.10(b)(4), (8) because it did not need to use CPR or an AED on Resident 5 because he had a pulse the whole time he was under Petitioner’s care. *Id.* This argument misconstrues CMS’s allegations related to this requirement. Although CMS does argue that Petitioner should have administered CPR to and used an AED on Resident 5 pursuant to § 483.10(b)(4), (8), CMS also argues that Petitioner violated those requirements by “fail[ing] to implement Resident 5’s advanced directive by not . . . following its policies for an emergency . . . .” CMS Br. at 23. Therefore, even assuming Petitioner is correct that Resident 5 had a pulse while he was in Petitioner’s care and thus did not need CPR or an AED, that does not mean Petitioner substantially complied with § 483.10(b)(4), (8).
Apparently sensing the inadequacy of its primary argument related to § 483.10(b)(4), (8), Petitioner also argues that “the evidence at hearing will establish that the tag [F155] must be deleted because the facility promptly identified Resident 5’s Full Code status and provided care appropriate to that status while awaiting arrival of the EMS team.” P. Br. at 20. Even assuming Petitioner is correct that it provided appropriate care to Resident 5 in this particular instance, however, and as already discussed, Petitioner’s failure to comply with § 483.10(b)(4), (8) by fully following its advance directives and code blue policies and procedures created a risk of harm to Petitioner’s full code residents that was larger than the specific medical emergency experienced by Resident 5.
For these reasons, I conclude that as a matter of law, Petitioner did not substantially comply with 42 C.F.R. §§ 483.20(k)(3)(i), 483.25, and 483.10(b)(4), (8).
***b. Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282) because it failed to implement care plans for two of its residents, one of whom was hospitalized as a result.***
The regulation at 42 C.F.R. § 483.20(k)(3)(ii) provides that “[t]he services provided or arranged by the facility must . . . [b]e provided by qualified persons in accordance with each resident’s written plan of care.” A facility can fail to comply substantially with § 483.20(k)(3)(ii) if it fails to comply with the plan of care, even if the facility’s personnel are qualified to provide the services called for by the plan of care. *Oaks of Mid*
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*City Nursing & Rehab. Ctr.*, DAB No. 2375 at 18 (2011); *see also Woodland Oaks Healthcare Facility*, DAB No. 2355 at 15 (2010).
Based on the surveyors’ findings, CMS determined that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) and that Petitioner’s violation of this requirement caused actual harm to a resident. CMS Ex. 1 at 19; CMS Ex. 2 at 29-34. With respect to Resident 6, CMS determined that Petitioner did not implement an adequate plan of care to address Resident 6’s tracheostomy and laryngectomy. CMS Ex. 2 at 29. Specifically, CMS determined that Petitioner “failed to implement or clarify Resident #6’s orders related to oxygen administration, tracheostomy care, laryngectomy tube care, and suctioning, until 10 days after admission.” *Id*. With respect to Resident 7, CMS determined that Petitioner did not implement the care plan for managing Resident 7’s diabetes. Specifically, CMS determined that after Petitioner gave Resident 7 insulin, Resident 7 “was lethargic throughout the morning,” but Petitioner did not recheck the resident’s blood glucose level, resulting in Resident 7’s “admi[ssion] to the hospital related to altered mental status secondary to hypoglycemia.” *Id.* at 29-30.
Petitioner did not request a hearing to challenge CMS’s determination that it did not substantially comply with 42 C.F.R. § 483.20(k)(3)(ii).13
 Therefore, that determination is final and binding. 42 C.F.R. § 498.20(b). The undisputed facts support CMS’s determination that Petitioner violated § 483.20(k)(3)(ii) and that Petitioner’s violation caused actual harm to Resident 7.14
 Resident 7 was diagnosed with type II diabetes and was insulin dependent. CMS Ex. 2 at 32-33. Petitioner’s policy for treating residents with diabetes was to ensure they received care “according to accepted standards of care focused on maintaining blood glucose control and preventing both acute and chronic complications.” CMS Ex. 2 at 32. According to the policy, Petitioner was to identify symptoms that accompany high and low blood glucose for its diabetic residents and assess and respond to any changes in those residents’ conditions. *Id*. Resident 7’s May 2016 MAR instructed that, if Resident 7’s blood glucose fell below 60 mg/dl, staff were
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to provide Resident 7 with 4 ounces of orange juice and a snack, recheck blood glucose in 15 minutes, and notify the resident’s physician. *Id.* at 32-33. Resident 7’s May 2016 treatment administration record listed the following early signs and symptoms that Resident 7 was experiencing low blood sugar: anxiety, shakiness, dizziness, paleness, and unusual hunger. *Id.* at 33. Later, more serious signs of prolonged low blood sugar included loss of coordination, lethargy, weakness, confusion, and loss of consciousness. *Id*. Resident 7’s care plan noted that the most common symptom of low blood glucose was a change in mental status and the most common symptom of high blood glucose was an angry outburst. *Id*. The care plan included interventions for managing the diabetes, such as monitoring blood glucose levels, administering oral hypoglycemic medications or insulin as ordered, monitoring for signs and symptoms of low or high blood glucose, and notifying the physician if blood glucose levels were at 400 or above or at 60 or below. *Id*.
On May 26, 2016, at around 7:00 a.m., Resident 7 was experiencing lethargy. *Id.* Resident 7’s blood glucose level at that time was 208 mg/dl, and nursing staff administered 4 units of insulin at 7:30 a.m. According to a situation, background, appearance, and review (SBAR) communication form filled out around 10:00 a.m. on the same day, Resident 7 experienced a change of condition, with symptoms including shortness of breath, confusion, and weakness—all possible symptoms of low blood glucose. *Id*. Nursing staff did not reassess Resident 7’s blood glucose level. *Id*. A prehospital care report indicated that at 10:40 a.m., Resident 7’s blood glucose level was 34 mg/dl, significantly lower than the level that should have triggered interventions for low blood glucose. *Id*. Resident 7 was admitted to the hospital for treatment of encephalopathy (brain injury) and altered mental status secondary to low blood glucose. *Id*. The nurse who had administered insulin to Resident 7 on that morning indicated to the surveyors that although she observed Resident 7 becoming more lethargic throughout the morning and knew Resident 7 was diabetic, she did not think to check Resident 7’s blood glucose level after administering the insulin. *Id.* at 33-34. She explained that she forgot to check blood glucose because she believed Resident 7 was experiencing a change in respiratory status. *Id.* at 34. According to Petitioner’s DON, the nurse should have checked Resident 7’s blood glucose level as part of the assessment for the SBAR report for the physician. *Id*. The DON further stated that anytime a diabetic resident experiences a change in condition, staff should check the resident’s blood glucose level. *Id*.
In summary, Resident 7 was hospitalized with secondary effects of hypoglycemia, including brain injury and altered mental status due to Petitioner’s noncompliance. *Id.* at 33. The harm experienced by Resident 7 could have been avoided had Petitioner followed Resident 7’s care plan and discovered and treated the hypoglycemia timely. Consequently, I conclude that as a matter of law, Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(k)(3)(ii).
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***c. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(k) (Tag F328) because it failed to provide Resident 6 timely special treatment and care for a tracheostomy and laryngectomy.***
The regulation at 42 C.F.R. § 483.25(k) provides, among other things, that “[t]he facility must ensure that residents receive proper treatment and care for the following special services: . . . [t]racheostomy care [and] [t]racheal suctioning . . . .” 42 C.F.R. § 483.25(k)(4), (5).
Based on the surveyors’ findings, CMS determined that Petitioner violated 42 C.F.R. § 483.25(k) and that Petitioner’s violation of this requirement posed a risk of more than minimal harm to resident health and safety. CMS Ex. 1 at 19; CMS Ex. 2 at 40-43. With respect to Resident 6, CMS determined that Petitioner did not ensure that it could satisfy Resident 6’s special treatment needs related to a tracheostomy and laryngectomy. CMS Ex. 2 at 40-41. Specifically, CMS determined that although Resident 6 was admitted to the facility on May 16, 2016, Petitioner did not obtain (1) physician’s orders for the resident’s “suctioning, and trach care needs . . . until 5/17/16,” (2) “oxygen administration orders . . . until 5/27/16,” (3) “orders for an air compressor to deliver humidified air . . . until 6/3/16,” and (4) “orders for parameters for the humidified air [until] 6/07/16.” *Id.* at 41.
Petitioner also did not request a hearing to challenge CMS’s determination that it did not substantially comply with 42 C.F.R. § 483.25(k). Therefore, that determination also is final and binding. 42 C.F.R. § 498.20(b). The undisputed facts support CMS’s determination that Petitioner violated § 483.25(k) and that Petitioner’s violation posed a risk of more than minimal harm to resident health and safety.
Resident 6 was admitted to the facility on May 16, 2016, after being discharged from the hospital. CMS Ex. 2 at 29. Resident 6 had a history of laryngeal cancer and had previously had a tracheostomy, a surgical procedure creating an opening in the neck to give access to the trachea, and laryngectomy, or surgical removal of the larynx. *Id.* at 29-30. Resident 6 also had a laryngectomy tube. *Id.*
Upon admission, Resident 6 needed tracheostomy care, laryngectomy care, oxygen via humidified tracheostomy mask, and suctioning. *Id.* at 29-32, 40-44. Although these needs were apparent from the hospital patient care referral form and discharge summary, dated May 16, 2016, it took Petitioner some time to clarify and implement all of the orders related to those care needs. *Id.* at 29, 40. For example, the discharge summary stated that Resident 6 was to receive oxygen at three liters per minute via humidified tracheostomy mask at 24% FIO2 (fraction of inspired oxygen). CMS Ex. 2 at 41. However, physicians orders upon admission to Petitioner’s facility on May 16, 2016, did
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not include orders for oxygen, a humidified tracheostomy mask, FIO2 parameters, tracheostomy and laryngectomy care, or suctioning. *Id.* at 40-41, 43. This was largely due to confusion among Petitioner’s staff about the meaning of the hospital discharge summary. *Id.* at 43. The first orders related to suctioning and tracheostomy care were dated May 17, 2016. *Id.* at 42. The first order related to oxygen administration was dated May 27, 2016. *Id.* at 30, 41. In addition, there was no order for an air compressor to deliver humidified air until June 3, 2016, and an order for the parameters of the humidified air was not instituted until June 7, 2016. *Id.* at 41. According to Petitioner’s DON, Petitioner should have consulted with the respiratory therapist before admitting Resident 6, yet no such consultation happened until June 3, 2016. *Id.* at 43-44.
Thus, Petitioner’s records demonstrate that Resident 6 had immediate care needs related to a tracheostomy and laryngectomy upon admission to the facility, yet Petitioner inexplicably delayed obtaining physician orders for some of those care needs. These delays posed a risk that Resident 6 would receive inadequate care for those special needs and thereby suffer harm. Consequently, I conclude that as a matter of law, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(k).
***3. CMS’s immediate jeopardy determination was not clearly erroneous.***
CMS asserts that Petitioner’s deficiency constituted an isolated instance of immediate jeopardy to resident health and safety (i.e., the “J” scope and severity level) from May 27 through June 7, 2016. CMS Br. at 2, 12-13; CMS Ex. 1 at 1, 7; CMS Ex. 2 at 1, 7. Petitioner argues that the immediate jeopardy citation was inappropriate because its “failure to follow its Code Blue Policy could not lead any reasonable trier of fact to conclude that serious harm was more than likely.” P. Br. 17.
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. The regulation does not require that a resident *actually*be harmed. *Lakeport Skilled Nursing Ctr.*, DAB No. 2435 at 8 (2012). I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The “clearly erroneous” standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy. Appellate panels of the DAB have sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” *See, e.g.*,*Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (citing*Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)), *aff’d*,*Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006). “Summary judgment on the severity of noncompliance is appropriate only if no reasonable trier of fact, viewing the evidence in the light most favorable to [the facility] and drawing all reasonable favorable inferences from that evidence, could conclude that
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serious harm was less than likely.” *Innsbruck HealthCare Ctr.*, DAB No. 1948 at 6 (2004) (emphasis in original).
The situation in which Petitioner’s noncompliance became apparent—a resident experiencing a medical emergency that involved unconsciousness, difficulty breathing, and eventually cardiac arrest—is by its very nature serious. As discussed in section IV.B.2.a, *supra*, delay in delivering care and services to a resident experiencing such an emergency could cause serious harm, up to and including brain damage and death. Petitioner’s noncompliance created the possibility that such serious harm, arising from delays that might be caused by that noncompliance, would befall a resident experiencing a medical emergency while in Petitioner’s care. I assume, for purposes of summary judgment, that Petitioner’s noncompliance did not actually inflict serious injury, harm, impairment, or death on Resident 5. The question, then, is whether such harm was “likely” to arise from Petitioner’s noncompliance.15
 Even when viewing the evidence in the light most favorable to Petitioner and drawing all reasonable favorable inferences from that evidence, I conclude that no reasonable trier of fact could conclude that serious harm was less than likely to arise from Petitioner’s noncompliance in this case.
As I have described above, Petitioner’s staff failed to follow ten separate procedures in Petitioner’s code blue policy. I summarize here those failures and the risks associated with them for the reader’s convenience:
Neither of the staff members who initially observed Resident 5 experiencing a medical emergency called out “code blue,” activated the call bell system, or paged code blue or the location of the emergency on the intercom, violating three separate code blue procedures. CMS Ex. 10 at 1; P. Ex. 4 at 12; P. Ex. 5 at 6; P. Ex. 6 at 7, 9, 12, 17. These lapses could have delayed dissemination of critical information—that there was an emergency and the location of the emergency—and thereby delayed response by Petitioner’s nursing staff and, later, EMS responders.
	No one took clear responsibility as code leader to coordinate care for Resident 5, creating significant confusion about who was in charge of the code response, violating another code blue procedure. CMS Ex. 10 at 1-2; P. Ex. 4 at 12; P. Ex. 5 at 4, 6-7; 6 at 2, 4-5, 7, 9-10, 15-17, 19-20, 26. Having no clear code leader could have led to duplicated, wasted effort by staff and conflicting orders regarding what care to provide Resident 5, which could have delayed Petitioner from providing necessary care to Resident 5.**Page 23**
No one designated a staff member to greet EMTs at the door and no one guided EMTs to the scene of the emergency, violating two additional code blue procedures. CMS Ex. 5 at 15-16; CMS Ex. 10 at 2; P. Ex. 6 at 14. These failures could have delayed the EMTs from arriving at the scene of the emergency to begin providing necessary care and transport to the hospital or other urgent care facility.
	No one designated another staff member to complete a transfer referral or copy Resident 5’s face sheet or MAR, violating yet another code blue procedure; this task was completed only because a staff member took it upon herself to do it. CMS Ex. 10 at 2; P. Ex. 5 at 2, 5; P. Ex. 6 at 6-7. This could have caused a delay in transferring a resident from the facility to the hospital, and it created a risk that the resident would receive incorrect or even harmful types or amounts of medications in the middle of a serious medical emergency.
	No one assigned a nurse to document the events of the code on the code blue flow sheet while the code was ongoing; instead, the events of the code were incompletely documented after the code ended, violating an eighth code blue procedure. CMS Ex. 4 at 5; P. Ex. 4 at 12-13; P. Ex. 5 at 4, 8; P. Ex. 6 at 18. Failing to document the emergency in real time could have prevented Petitioner from identifying and, going forward, correcting the other failures listed here, creating a risk of delays and harm in a future code blue emergency in the facility.
	No one actively sought out the director of nurses, assistant director of nurses, and all the nurse managers, even though they were listed as “[s]taff responding to a ‘Code Blue’” during the 7-3 shift in a code procedure. CMS Ex. 10 at 2; P. Ex. 5 at 5; P. Ex. 6 at 6. This could have delayed response to the emergency by the very people Petitioner had identified as necessary responders to a code blue situation.
	Finally, Petitioner did not conduct code blue drills for at least a year prior to Resident 5’s emergency, violating the procedure requiring routine drills.16
 CMS Ex. 10 at 2; P. Ex. 4 at 8; P. Ex. 5 at 3-4, 6-8; P. Ex. 6 at 1, 7, 10, 14-15, 18, 22, 28.The only reasonable inference to be drawn from these numerous failures is that Petitioner’s staff members were unprepared to handle a live code blue situation in the facility. This lack of preparedness is attributable in large part to Petitioner’s failure to hold a code blue drill for at least a year prior to Resident 5’s emergency. Petitioner’s failure to conduct drills to ensure staff were prepared for a code blue situation made it far more likely that staff would fail to follow code blue procedures, as in fact happened. As a consequence, there was an increased risk that Petitioner’s response to a medical
**Page 24**
emergency would be delayed, with the result that a resident might suffer harm. Moreover, Petitioner’s failure to conduct code blue drills increased the risk that such failures would occur and recur in future code blue situations.
In essence, Petitioner’s only argument on this point is that, under the circumstances, its response to Resident 5’s medical emergency was reasonable and sufficient to bring into question the conclusion that serious harm was likely, precluding summary judgment on the immediate jeopardy issue. P. Br. at 17. I disagree. The harm that could have arisen from Petitioner’s noncompliance was serious. Any or all of the potential delays attributable to Petitioner’s lack of preparation could have contributed to the significant harms (including brain damage and death) that can arise from failing to provide timely medical care to an individual suffering from a medical emergency such as cardiac arrest. SOM, CMS Pub. 100-07, Appendix PP. No reasonable factfinder could look at the extent of Petitioner’s failures and conclude that serious harm was less than likely to befall a resident experiencing a medical emergency while in Petitioner’s care, such as the one experienced by Resident 5. At best, even assuming Resident 5’s care was not actually affected by Petitioner’s deficiencies in this instance, the only reasonable conclusion is that Petitioner was simply fortunate that Resident 5 was not actually harmed by its noncompliance. The potential for harm nonetheless existed, the potential harm clearly was serious, and no reasonable factfinder could conclude that serious harm was less than likely to befall Resident 5 or a similarly-situated resident.
In light of the foregoing, I conclude that as a matter of law, CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25 posed immediate jeopardy to the health and safety of Petitioner’s residents was not clearly erroneous.
***4. The remedy imposed is reasonable in amount and duration.***
Regarding the amount of the CMP, I examine whether a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. The factors listed in § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies. Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it. *Coquina Ctr.*, DAB No. 1860 at 32 (2002).
The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408; 488.438. The upper
**Page 25**
range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of a CMP, $50 to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). In assessing the reasonableness of a CMP amount, an ALJ looks at the per-day amount, rather than the total accrued CMP. *See Kenton Healthcare, LLC*, DAB No. 2186 at 28 (2008). The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range. 42 C.F.R. §§ 488.408; 488.408(g)(2); 498.3(d)(11); *see also*42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare, LLC*, DAB No. 2186 at 28-29.
CMS decided to impose per-day CMPs in this case, and I have found that CMS’s determination that Petitioner’s noncompliance represented immediate jeopardy was not clearly erroneous. For the period of Petitioner’s immediate jeopardy level noncompliance (relating to Petitioner’s response to Resident 5’s medical emergency), CMS imposed a CMP of $7,350 per day, which is in the middle-to-high range for immediate jeopardy level noncompliance. For the period of Petitioner’s below immediate jeopardy level noncompliance (relating to Petitioner’s care of Residents 6 and 7), CMS imposed a CMP of $1,650 per day, which is in the middle of the range for below immediate jeopardy level noncompliance.
CMS argues that the per-day CMPs imposed are reasonable because Petitioner’s noncompliance was severe, given that Resident 5 died and Resident 7 was hospitalized, and the fact that the CMPs imposed were lower than the maximum $10,000 per day authorized for immediate jeopardy noncompliance and $3,000 per day authorized for non-immediate jeopardy noncompliance. CMS Br. at 24-25. Petitioner argues in response that reduction of the severity, or outright elimination, of the noncompliance cited by CMS would require reduction or elimination of the CMP(s) imposed due to the originally-cited noncompliance. P. Br. at 20-21.
I note at the outset that I have neither eliminated nor reduced any of the noncompliance cited by CMS. To the contrary, I have concluded that Petitioner did not substantially comply with all of the requirements cited by CMS as bases for imposing CMPs on Petitioner and that Petitioner’s noncompliance with some of those requirements posed immediate jeopardy. Petitioner’s argument, construed narrowly, provides no basis to reduce or eliminate the CMPs imposed by CMS, because it does not specifically argue that any particular regulatory factor supports a reduction of the CMP amounts proposed by CMS. *See Coquina Ctr.*, DAB No. 1860 at 32. However, a more generous construction of Petitioner’s argument suggests that Petitioner believes the amounts of the
**Page 26**
CMPs are unreasonable because its noncompliance was not severe enough to warrant such high CMPs.
*Amount*. As my analysis in sections IV.B.2 and IV.B.3, *supra*, shows, Petitioner’s noncompliance, both at and below the immediate jeopardy level, was very serious. Petitioner failed to institute regular code blue drills, holding not one for at least a year prior to Resident 5’s code blue emergency. This lack of preparation showed in the numerous breakdowns in Petitioner’s response to the emergency, as measured against Petitioner’s code blue policy and procedures. Even assuming that Resident 5’s death had nothing to do with Petitioner’s noncompliance, it is apparent that another full code resident, or even Resident 5 under different circumstances, easily could have died or at least suffered serious negative health consequences from Petitioner’s noncompliance. Even when viewing the evidence in the light most favorable to Petitioner, the best that can be said is that Petitioner’s failure to implement its code blue policy and thereby provide care and services that met accepted professional standards of quality was a result of Petitioner’s neglect of, if not indifference to or outright disregard for, its residents’ health and safety. I agree with CMS that this serious immediate jeopardy-level noncompliance is more than adequate to support a $7,350 per-day CMP, especially considering it arose from Petitioner’s own neglect. Consequently, I conclude that as a matter of law, the $7,350 per-day CMP imposed for Petitioner’s immediate jeopardy noncompliance, which is considerably less than the $10,000 maximum CMP that CMS could have imposed for such noncompliance, is reasonable in amount.
In addition, Petitioner’s failure to provide care consistent with Resident 7’s care plan put the resident in the hospital with symptoms secondary to hypoglycemia, a condition easily avoidable had Petitioner implemented its own policy and the resident’s care plan. Similarly, Petitioner’s noncompliance put Resident 6 at risk of not receiving the special care needed to treat the resident’s tracheostomy and laryngectomy, thereby exposing the resident to the possible risk of harm from inadequate care. These undisputed instances of noncompliance, combined with Petitioner’s failure to implement its own advance directives policy with respect to all its full code residents, fully supports a $1,650 per-day CMP. Thus, I also conclude that as a matter of law, the $1,650 per-day CMP imposed for Petitioner’s non-immediate jeopardy noncompliance, which is just over half the maximum possible CMP that CMS could have imposed for such noncompliance, is reasonable in amount.
*Duration*. The parties’ arguments about the reasonableness of the CMPs focus on the amount of the CMPs; they make no specific arguments about the reasonableness of the proposed duration of the CMPs. Considering Petitioner’s immediate jeopardy noncompliance was revealed by an incident that occurred on March 1, 2016, Petitioner is fortunate that CMS decided to impose the immediate jeopardy level CMP beginning on May 27, 2016. Petitioner does not assert that it abated the immediate jeopardy conditions until June 8, 2016, as alleged by CMS. Indeed, Petitioner’s own plan of correction for its
**Page 27**
immediate jeopardy noncompliance indicates that it would not complete its corrective measures, including educating staff and conducting a series of code blue drills to confirm that staff education was successful, until well after June 8, 2016. CMS Ex. 2 at 25-28, 34-37. The record thus supports the reasonableness of the duration of the immediate jeopardy level CMP. As for the below immediate jeopardy level CMP, CMS submitted evidence that Petitioner returned to substantial compliance with Medicare participation requirements on June 29, 2016. *Id.* at 18-20, 29-30, 41. Petitioner in turn failed to present evidence that it returned to substantial compliance prior to June 29, 2016. Petitioner has thus not raised a dispute of material fact as to the reasonableness of the duration of the proposed CMPs. I therefore conclude that as a matter of law, the duration of the proposed CMPs is reasonable.
V. Conclusion
For the reasons set forth above, I sustain CMS’s determinations. I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.10(b)(4), (8); 483.20(k)(3)(i), (ii); 483.25; and 483.25(k). I further conclude that CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25 posed immediate jeopardy to resident health and safety. I finally conclude that the imposed CMPs, a $7,350 per day CMP effective May 27 through June 7, 2016, and a $1,650 per day CMP effective June 8 through June 28, 2016, a total CMP of $122,850, are reasonable. I reach these conclusions even when viewing the evidence in the light most favorable to Petitioner and drawing all reasonable inferences in Petitioner’s favor. In light of the foregoing, I grant CMS’s motion for summary judgment.


          /s/
        Leslie A. Weyn

                      Administrative Law Judge
      1. Petitioner seeks rescission of the NATCEP prohibition.  Petitioner’s NATCEP became ineligible for approval by operation of law.  See Act § 1819(f)(2)(B)(iii)(I)(c) (42 U.S.C. § 1395i‐3(f)(2)(B)(iii)(I)(c)) (prohibiting approval of a NATCEP if offered by a SNF that “has been assessed a civil money penalty . . . of not less than $5,000”).  I have no authority to restore Petitioner’s eligibility to conduct a NATCEP except to the extent that I conclude that the CMPs at issue were wrongly imposed.  The two-year period of ineligibility has already expired.  Moreover, as I explain below, I conclude that CMS had a basis to impose on Petitioner CMPs totaling more than $5,000.  Consequently, I do not further discuss this issue. back to note 1
                      2. CMS filed two versions of its reply on the same day.  In a cover letter submitted with the second version, CMS indicated it was filing a corrected version of its reply to “correct[] a typographical error” contained in the original version.  I interpret this filing as a request to withdraw the original version of CMS’s reply (docket entry 6a) and substitute with the corrected version of the reply (docket entry 7a).  As Petitioner did not object to CMS filing a corrected version of the reply, I grant CMS’s implicit request insofar as I consider only the corrected version of the reply in rendering my decision. back to note 2
                      3. CMS recently increased the CMP amounts to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  See 81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).  The inflation-adjusted amounts apply to CMPs assessed after August 1, 2016, for deficiencies occurring on or after November 2, 2015.  Id. at 61,538.  As the CMPs in this case were assessed prior to August 1, 2016, the increased CMP amounts do not apply in this case. back to note 3
                      4. My conclusions of law appear as numbered headings in bold italic type.  My findings of undisputed fact appear in the supporting text. back to note 4
                      5. The quoted material appears under the heading “Determination of Compliance” and the subheading “Criteria for Compliance.”  Throughout the remainder of this decision, I refer to Rev. 133 when citing to the SOM. back to note 5
                      6. To protect the resident’s privacy, and that of his family, I refer to him by the numerical identifier assigned during the survey and recorded in the statement of deficiencies. back to note 6
                      7. Full code status indicates that all appropriate life-saving measures, including attempts at resuscitation, should be used to save the person’s life.  P. Br. at 19; CMS Ex. 2 at 3, 19; CMS Br. at 2. back to note 7
                      8. The parties vigorously dispute exactly when Resident 5 went into cardiac arrest.  However, as discussed further in the next section, the exact timing of Resident 5’s cardiac arrest does not affect the outcome of this case.  What matters is that Resident 5 did eventually experience cardiac arrest, which the parties do not dispute. back to note 8
                      9. The record does not show that Petitioner’s assistant DON and all nurse managers were made aware of and responded to the emergency in the same manner as the DON was (or at all, for that matter), as required by procedure H.  CMS Ex. 10 at 2.  However, it is not clear from the record that Petitioner even had an assistant DON or any nurse managers who were not made aware of and did not respond to the emergency. back to note 9
                      10. As noted above, the staff who initially greeted the EMTs in fact did not know where the emergency was.  Fortunately, it does not appear that this delayed the EMTs from arriving on the scene, but it at least had the potential to create a delay. back to note 10
                      11. This also happened here, and again, while it does not appear that the EMTs were delayed as a result, there was at least the potential for a delay. back to note 11
                      12. And while I assume for summary judgment purposes that he did not, it is not clear that he did not actually go into cardiac arrest before EMTs arrived and assumed responsibility for his care. back to note 12
                      13. Although Petitioner did not contest the deficiency citation based on its failure to comply with 42 C.F.R. § 483.20(k)(3)(ii), I discuss the facts related to this deficiency to make clear why I conclude below, in section IV.B.4 of this decision, that the remedies imposed are reasonable in amount.  For the same reason, I discuss the facts related to Petitioner’s noncompliance with 42 C.F.R. § 483.25(k) in section IV.B.2.c of the decision. back to note 13
                      14. The undisputed facts also support CMS’s determination that Petitioner failed to comply substantially with 42 C.F.R. § 483.20(k)(3)(ii) in its care of Resident 6.  However, the noncompliance cited with respect to the care of Resident 7 is sufficient to support the deficiency citation.  Therefore, I do not discuss the facts relating to Resident 6 in detail here.  I discuss the care provided to Resident 6 in more detail below in section IV.B.2.c of this decision. back to note 14
                      15. For purposes of this decision, I assume that “likely” to cause serious harm to a resident means that such an outcome is more likely than not.  In other words, a harmful outcome is “likely” if there is a greater than 50% chance that serious harm will occur.  My point here is that serious harm is “likely” even if there is a 49% chance that serious harm to a resident will not occur. back to note 15
                      16. There is evidence that Petitioner provided training to some of its staff about code blue procedures.  P. Ex. 5 at 7; P. Ex. 6 at 22, 28.  Such training apparently consisted of reviewing the written procedures with staff.  P. Ex. 6 at 22, 28.  However, given the significant breakdowns in following the code blue procedures that occurred during an actual emergency, it would be unreasonable to infer that whatever education Petitioner provided was effective as a replacement for the drills. back to note 16 Back to top
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