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                              Gardens of McGregor and Amasa Stone, DAB CR5947 (2021)
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Gardens of McGregor and Amasa Stone, DAB CR5947 (2021)








  
  
    

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





Gardens of McGregor and Amasa Stone
(CCN: 366350),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-92Decision No. CR5947September 23, 2021

        
              
    

      DECISION

Petitioner, Gardens of McGregor and Amasa Stone (Petitioner or “the facility”), is a skilled nursing facility (SNF) that participates in the Medicare program.  Based on a survey that was completed on March 26, 2018, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with Medicare participation requirements.  I uphold the determination of noncompliance, along with the imposition of a $19,500 per-instance civil monetary penalty (PICMP).  To the extent CMS based its determination that Petitioner could not conduct a nurse aide training and competency evaluation program (NATCEP) for two years on a finding of substandard quality of care that resulted in a partial extended survey, I uphold the immediate jeopardy determination that is the basis for the finding of substandard quality of care.

I.  Background

The Social Security Act (Act) establishes requirements for SNF participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  *See*

**Page 2**

42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, SNFs must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  *Id*.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‐3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance, or a PICMP for each instance of noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).

If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  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).

Surveyors from the Ohio Department of Health (“state agency”) completed a partial extended survey and complaint investigation on March 26, 2018.  CMS Exs. 1 at 1; 21 at 1.  The state agency found that the facility was not in substantial compliance with the Medicare participation requirement at 42 C.F.R. § 483.24(a)(3) (Tag F678, cited at the “J” level of scope and severity).1
  CMS Ex. 1 at 1.  In a letter dated September 5, 2018, CMS informed Petitioner that it concurred with the state agency’s determination, at which time it imposed a PICMP of $19,500.  CMS Ex. 5 at 2.  CMS also explained that because Petitioner had been subject to a partial extended survey as a result of a finding of

**Page 3**

substandard quality of care,2
 it would lose approval to conduct its NATCEP for two years.  CMS Ex. 5 at 4.

Petitioner, through counsel, timely requested a hearing on November 2, 2018.3
  CMS filed a pre-hearing brief and motion for summary judgment (CMS Br.) and 26 proposed exhibits (CMS Exs. 1-26), and Petitioner filed a pre-hearing brief and response to CMS’s motion for summary judgment (P. Br.), along with six proposed exhibits (P. Exs. 1-6).

CMS submitted the written direct testimony of a surveyor (CMS Ex. 21) and Jeffrey M. Rothschild, M.D., M.P.H. (CMS Ex. 23).  Petitioner submitted the sworn testimony of Daniel J. Cannone, DO, CMD (P. Ex. 1) and an unsworn statement of Peter A. DeGolia, M.D. (P. Ex. 3).  Neither party has requested an opportunity to cross-examine witnesses, and therefore, a hearing is unnecessary.  This case is ready for a decision on the merits.4

II.  Issues

The following issues will be addressed in this decision:

1) Whether Petitioner failed to substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.24(a)(3) (cited as Tag F678);

2) Whether the immediate jeopardy determination that is the basis for the finding of substandard quality of care and loss of NATCEP approval is clearly erroneous; and

3) Whether a PICMP of $19,500 is reasonable.

III.  Discussion5

***1.  Petitioner’s staff witnessed Resident # 202 become unresponsive on February 28, 2018.***

**Page 4**

***2.  Petitioner’s staff initiated its code protocol, to include cardiopulmonary resuscitation (CPR).***

***3.  Petitioner’s staff administered compression-only CPR.***

Resident # 202, a woman born in 1930, was admitted to the facility on February 23, 2018, upon her discharge from her most recent hospitalization for treatment of enterococcal septicemia, infectious endocarditis, E. Coli urinary tract infection, and a penicillin allergy.  CMS Exs. 9 at 1; 11 at 7.  Prior to her hospitalization, Resident # 202 “enjoy[ed] interacting with others in social settings, going out in the community, playing games, and crafting on occasion.”  CMS Ex. 11 at 2.  Resident # 202 had a primary admitting diagnosis of congestive heart failure, and a complicated medical history that included diagnoses of sepsis, hypertension, cerebral infarction, carotid stenosis, aortic stenosis, Type II Diabetes Mellitus, and dyspnea.  CMS Ex. 9 at 1.  An “Order Summary Report,” dated February 28, 2018, documents Petitioner’s receipt of a February 26, 2018 “FULL CODE” order for Resident # 202.  CMS Ex. 10 at 2 (capitalization in original).

At 2:00 am on February 28, 2018, Petitioner notified Resident # 202’s treating provider that she had low blood pressure.  CMS Ex. 11 at 2.  At 8:00 am, a state tested nurse aide (STNA) who had assisted Resident # 202 with toileting reported that Resident # 202 had a large amount of loose stool, her “face was swollen like a chipmunk, lips were puffy and pink, [and] upper torso had red raised hive[-]like rash both anteriorly and posteriorly.”  CMS Ex. 11 at 1.  Resident # 202 reported that she was not in pain, but that she was itchy.  CMS Ex. 11 at 1.  After Petitioner’s staff obtained vital signs, a nurse called Resident # 202’s physician at 8:05 am and received orders to administer Benadryl and discontinue antibiotic treatment.  CMS Ex. 11 at 1.

At 8:10 am, the STNA reported to the nurse that “something was wrong with [the] resident.”  CMS Ex. 11 at 1.  The STNA explained that she notified the nurse after Resident # 202 “sat down [and] her eyes bulged out and rolled back.”  CMS Ex. 15 at 2.6
  A responding nurse, Ms. Deener, documented that she administered a sternal rub; although the resident “took [a] deep breath,” she was otherwise nonresponsive to the sternal rub.  CMS Ex. 11 at 1.  After Ms. Deener could not detect a pulse through palpation or a Dinamap,7
 she initiated Petitioner’s code protocol at 8:15 am, at which time the “emergency response team [was] called.”  CMS Ex. 11 at 1.  Another nurse,

**Page 5**

Ms. Evans, documented that she “put [a] nonrebreather [mask]”8
 on Resident # 202 (CMS Ex. 15 at 7), but a registered nurse, Ms. Parkinson, documented that staff administered “oxygen turned up via a nasal cannula in the patient’s nose.”  CMS Ex. 13 at 1.

A handwritten and unsigned “timeline” documented by Petitioner, dated February 28, 2018, reports the following course of events:

**0805** Nurse received [order] to stop [antibiotics and] give Benadryl.**0810** Nurse at cart preparing medication[,] STNA notified change [of] condition[,] entered room.**0815** Code initiated.**0816** EMS called – Andrea secretary**0820** Nurse checked paperwork – door check**0821** Nurse went back to room – CPR was continuing.  Nurse notified [no] ambu bag.[9
]  Went to 3rd floor to retrieve.**0823** EMS arrived/Nurse arrived with ambu bag and followed EMS to room.  Took over CPR.

CMS Ex. 14 at 1.

An East Cleveland Fire Department (EMS) run sheet documents that the call was received at 8:16 am and a crew of paramedics and an emergency medical technician arrived on scene at 8:23 am, at which time Petitioner’s staff was performing compression-only CPR.  CMS Ex. 12 at 1, 3.  EMS assumed responsibility for Resident # 202’s care, to include performing chest compressions and ventilating Resident # 202 with a bag valve mask connected to supplemental oxygen at a flow rate of 15 liters per minute.  CMS Ex. 12 at 3.  At 8:25 am, EMS defibrillated Resident # 202.10
  CMS Ex. 12 at 3.  EMS thereafter applied a Lucas device that administered mechanical compressions.  CMS Ex. 12 at 3-4.  After transferring Resident # 202 to the ambulance, EMS

**Page 6**

endotracheally intubated Resident # 202 and established intraosseous infusion access.11
  CMS Ex. 12 at 4.  Although EMS briefly detected a carotid pulse at 8:42 am, cardiac monitoring only a minute later revealed pulseless electrical activity.  CMS Ex. 12 at 4.  At approximately 9:00 am, the receiving hospital notified Petitioner that Resident # 202 had expired.  CMS Ex. 13 at 1; *see*P. Ex. 3 at 1 (physician reporting notification received at 9:05 am).  Petitioner’s physician, Dr. DeGolia, reported that the hospital “diagnosed her death as due to an acute myocardial infarction,” which he stated was “consistent with her acute medical problem of infective endocarditis and chronic problems of serious cardiovascular disease.”  P. Ex. 3 at 1.

In a statement provided that same day, an LPN reported there was “no ambu bag on crash cart.”  CMS Ex. 15 at 7.  Petitioner’s handwritten timeline reported that within the hour following Resident # 202’s transfer to the hospital, a “check [was] performed [on] all carts.”  CMS Ex. 14 at 2.  The timeline further reported, “MD in Center notified of occurrence and ambu bag education to be initiate[d] and notified carts stocked [with] ambu bag.”  CMS Ex. 14 at 2.

CMS submitted the written testimony of Victoria S. Marunowski, RN, a surveyor for the state agency.  CMS Ex. 21; *see*CMS Ex. 1.  Ms. Marunowski testified that Petitioner’s “policies provided that when a resident is found unresponsive, the person to respond will ventilate a resident with an Ambu bag, that crash cart contents included Ambu bags, and that crash cart supplies should be immediately replaced after use.”  CMS Ex. 21 at 4.  Ms. Marunowski stated that Petitioner “failed to ventilate an unresponsive full code resident . . . for approximately eight minutes of cardiopulmonary resuscitation.”  CMS Ex. 21 at 3.

CMS submitted the written testimony of Jeffrey M. Rothschild, MD, MPH, an Associate Professor of Medicine at Harvard Medical School who holds board certification in both internal medicine and critical care medicine.  CMS Ex. 23; *see*CMS Ex. 24.  Dr. Rothschild testified that Petitioner “failed to comply with the standard of care of the average nursing staff” when it failed to provide ventilatory support to Resident # 202.  CMS Ex. 23 at 3.  Dr. Rothschild explained:

The initial response to a cardiopulmonary arrest in a patient with a full code status is basic life support (BLS) or cardiopulmonary resuscitation which includes chest compressions, airway management, rescue breathing/ventilation, rhythm detection and, if indicated, shocks/defibrillation by trained staff.  In my expert opinion, and according

**Page 7**

to the AHA’s Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Guidelines), CPR by trained medical personnel, including nurses such as at [the facility], includes chest compressions and ventilatory support with ambu bagging.

CMS Ex. 23 at 3.  Dr. Rothschild added that ventilatory support “was first provided approximately 13 minutes after the time of being found unresponsive and approximately 8 minutes from the time the code was activated.”  CMS Ex. 23 at 3.  Although Dr. Rothschild opined there was a chance Resident # 202 could have survived the initial resuscitation if Petitioner had provided ventilatory support, a “successful resuscitation *with*a good outcome” was “extremely unlikely.”  CMS Ex. 23 at 4 (emphasis in original).

Petitioner submitted the written testimony of Daniel Cannone, DO, CMD, a Clinical Professor of Geriatric Medicine at Ohio University Heritage College of Osteopathic Medicine, who is board certified in family medicine and is a Certified Medical Director.  P. Ex. 1; *see*P. Ex. 2.  Dr. Cannone opined that “[a]lthough an Ambu bag was not on the first emergency cart brought to the room, the facility had 2 additional emergency carts with Ambu bags, and an Ambu bag was promptly retrieved and brought to the scene.”  P. Ex. 1 at 3.  Dr. Cannone recognized that facility staff “are required to provide Basic Life Support (BLS), which includes the implementation of CPR,” and that staff provide “BLS for healthcare providers,” rather than advanced cardiac life support.  P. Ex. 1 at 2.

Petitioner also submitted an unsworn statement from Peter A. DeGolia, MD, who was Resident # 202’s physician at the facility.  P. Ex. 3.  Dr. DeGolia testified that he “did not suspect that [Resident # 202’s] death was unusual,” and that he had “no information to indicate that respiratory resuscitation prior to her intubation would have changed the outcome of [her] death.”  P. Ex. 3 at 1.

***4.  Pursuant to 42 C.F.R. § 483.24(a)(3), a facility is required to provide basic life support, to include CPR, to a resident requiring emergency care prior to the arrival of emergency medical personnel.***

***5.  Petitioner’s policy requires that the emergency cart on each floor include an Ambu bag.***

***6.  Petitioner has a policy that requires it to provide CPR to any resident, staff member, or visitor who is found in apparent cardiopulmonary arrest and does not have a valid do-not-resuscitate order.***

***7.  Petitioner’s policy incorporates the American Heart Association CPR for healthcare providers guideline that staff administering CPR both provide ventilation and perform chest compressions.***

**Page 8**

Pursuant to 42 C.F.R. § 483.24, which implements section 1819(b)(2) of the Act, “[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, consistent with the resident’s comprehensive assessment and plan of care.”  As relevant to the instant care, 42 C.F.R. § 483.24 further states:

(a) Based on the comprehensive assessment of a resident and consistent with the resident’s needs and choices, the facility must provide the necessary care and services to ensure that a resident’s abilities in activities of daily living do not diminish unless circumstances of the individual’s clinical condition demonstrate that such diminution was unavoidable.  This includes the facility ensuring that:

* * * *

(3) Personnel provide basic life support, including [cardio-pulmonary resuscitation] (CPR), to a resident requiring emergency care prior to the arrival of emergency medical personnel and subject to related physician orders and the resident’s advance directives.

42 C.F.R. § 483.24(a)(3).

The State Operations Manual (SOM), which provides guidance to surveyors, explains the following with respect to CPR:

In keeping the requirement at § 483.24 to “provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of the resident” facilities must ensure that properly trained personnel (and certified in CPR for Healthcare Providers) are available immediately (24 hours per day) to provide basic life support, to include [CPR], to residents requiring emergency care prior to the arrival of emergency medical personnel, and subject to accepted professional guidelines, the resident’s advance directives, and physician orders.

The American Heart Association (AHA) publishes guidelines every five years for CPR and Emergency Cardiovascular Care (ECC).  These guidelines reflect global resuscitation and treatment recommendations.  In the guidelines, AHA has established evidence-based decision-making guidelines for initiating CPR when cardiac or respiratory arrest occurs in or out of the hospital.

The AHA urges all potential rescuers to initiate CPR unless a valid Do Not Resuscitate (DNR) order is in place; obvious clinical signs of irreversible

**Page 9**

death (e.g., rigor mortis, dependent lividity, decapitation, transection, or decomposition) are present; or initiating CPR could cause injury or peril to the rescuer.

SOM (Pub. 100-7), Appendix PP (Rev. 173, Nov. 22, 2017); *see*CMS Ex. 25 at 3.

The AHA’s guidelines for CPR address protocols for both untrained rescuers and healthcare providers.  CMS Ex. 26.  The AHA directs untrained rescuers to provide chest compressions only, whereas the AHA instructs healthcare providers to provide both ventilation and chest compressions.  CMS Ex. 26 at 1-2.  The AHA explained, “Compression-only CPR is recommended for untrained rescuers because it is relatively easy for dispatchers to guide with telephone instructions.”  CMS Ex. 26 at 7.  Addressing CPR provided by healthcare providers, the AHA explained that “[i]t is expected that [healthcare providers] are trained in CPR and can effectively perform both compressions and ventilation.”  CMS Ex. 26 at 7.

The Departmental Appeals Board (DAB) has explained that facilities are bound by policies that incorporate the AHA’s CPR guidelines.  *North Las Vegas Care Ctr.*, DAB No. 2946 at 6 (2019)(“Petitioner’s failure to provide CPR to a full-code resident in cardiac arrest violated both an established resident care policy (the DNR policy) and an accepted professional standard of quality (reflected in the AHA’s CPR guidelines).”); *Green Valley Healthcare and Rehab.*, DAB No. 2947 at 7 (2019) (“Collectively these policies called upon Petitioner’s nursing staff to administer CPR, consistent with [AHA] practice guidelines, to any full-code resident – that is, to any resident without a valid DNR order . . . in cardiac arrest.”).

Petitioner has a “Doctor E” policy and procedure that is essentially a “Code Blue” type of protocol.  CMS Ex. 16.  The policy objective states that “[w]hen a Resident, staff member or visitor is found in apparent cardiopulmonary arrest or unresponsive, trained personnel will be notified of the emergency immediately so appropriate intervention is not delayed.”  CMS Ex. 16 at 1.  When “Doctor E” protocol is initiated, a staff member calls 911 and specified nursing staff and CPR-trained personnel are required to respond.  CMS Ex. 16 at 1.  The policy requires that “[t]he first nurse to respond will order another staff person to get the red crash cart and backboard,” and “[t]he nurse will prepare the victim for CPR (move to floor if in a wheelchair, position for CPR, etc.) and start chest compressions.”  CMS Ex. 16 at 1.  Upon arrival of the “crash cart,” the policy directs that “[t]he person to respond will ventilate the victim with the ambu bag attached to oxygen.”  The policy instructs that after a code, the “[r]ed crash cart will be cleaned and supplies replaced *immediately*.”  CMS Ex. 16 at 2 (emphasis added).

Petitioner also has an “Emergency Cart” policy and procedure directing that “[e]mergency carts [are] set up on each floor to provide quick access to equipment for utilization in the event of an emergency.”  CMS Ex. 17 at 1.  Under the heading,

**Page 10**

“Emergency [C]art Maintenance,” the policy directs that “[t]he emergency cart is checked nightly or after each use to ensure proper maintenance of equipment and available equipment.”  CMS Ex. 17 at 1.  The cart contents checklist includes the following items:  backboard, AED, oxygen tank, Ambu bag, oxygen mask, oxygen tubing, stethoscope, suction machine, Yankur, suction tubing, oral airway, box of gloves, clip board, basic dressings, tape, and protective equipment.  CMS Ex. 17 at 1.

***8. The emergency cart on Resident # 202’s floor did not contain an Ambu bag.***

*********9.  Because the emergency cart did not contain an Ambu bag, Petitioner did not comply with its own policy requiring that emergency carts be stocked with an Ambu bag.***

***10.  Petitioner was unable to obtain an Ambu bag until eight minutes after it initiated CPR, and as a result, it did not ventilate Resident # 202 prior to EMS taking over care.***

***11.  Because Petitioner did not ventilate Resident # 202, it did not comply with its policy incorporating the AHA guideline that CPR include both ventilation and chest compressions.***

***12.  Petitioner did not comply with 42 C.F.R. § 483.24(a)(3), which requires a facility to provide basic life support, to include CPR, to a resident requiring emergency care prior to the arrival of emergency medical personnel.***

Pursuant to 42 C.F.R. § 483.24(a)(3), Petitioner was required to provide basic life support, to include CPR, to Resident # 202.  Petitioner’s code policy incorporates the AHA CPR guidelines for healthcare providers requirement that personnel administering CPR both ventilate *and* perform chest compressions.  *See*CMS Exs. 16 at 1 (requiring staff to initiate ventilation with an Ambu bag as soon as the emergency cart arrives on scene); 26 at 3 (AHA CPR guideline that it is reasonable for trained rescuers to both ventilate and perform chest compressions); P. Ex. 1 at 2 (Dr. Cannone’s testimony that Petitioner provides basic life support for healthcare providers).  An STNA witnessed Resident # 202 lose consciousness (CMS Ex. 11 at 1), and Resident # 202 had “full code” status.  CMS Ex. 10 at 2.  Pursuant to 42 C.F.R. § 483.24(a)(3) and its own policy, Petitioner was required to ventilate Resident # 202 until EMS took over Resident # 202’s care.  By failing to ventilate Resident # 202 during the eight-minute course of CPR, Petitioner failed to provide basic life support required by both 42 C.F.R. § 483.24(a)(3) and its own policy.

**Page 11**

According to Petitioner’s own timeline, Resident # 202 had been unresponsive for five minutes prior to its initiation of CPR.12
  CMS Ex. 14 at 1.  And after Petitioner called a code and initiated CPR, Petitioner did not ventilate Resident # 202 because a bag valve mask was not on the emergency cart.  CMS Ex. 14 at 1.  A nurse obtained a bag valve mask from another floor of the facility, and the “[n]urse arrived with ambu bag and followed EMS to [the] room.”  CMS Ex. 14 at 1.  Being that Petitioner called a code at 8:15 am and EMS arrived at 8:23 am, Petitioner did not ventilate Resident # 202 for eight minutes.13
  CMS Exs 14 at 1.

Petitioner argues that the compression-only CPR provided by its staff was adequate.  P. Br. At 5-9.  While the AHA has determined that compression-only CPR is appropriate for an untrained rescuer, Petitioner’s nurses are trained healthcare providers who are expected to more capably provide basic life support than a lay rescuer.  *See*CMS Ex. 26 at 4 (“Compression-only CPR is easy for an untrained rescuer to perform and can be more effectively guided by dispatchers over the telephone.”); *see also*P. Ex. 1 at 2 (Dr. Cannone’s testimony that Petitioner provides basic life support for healthcare providers).  Petitioner, as a participant in the Medicare program, is reimbursed for *skilled*nursing services it provides to Medicare beneficiaries; its claim that it need only be held to a lay rescuer standard of basic life support is a meritless repudiation of the professionalism that should be expected from its nursing staff.  Petitioner’s own policy requires that its staff provide CPR consistent with the AHA guidelines for healthcare professionals that includes *both*ventilation and chest compressions.  CMS Ex. 16 at 1.

Petitioner’s emergency cart policy recognizes that the purpose of a stocked emergency cart is to allow for “quick access to equipment for utilization in the event of an emergency.”  CMS Ex. 17 at 1.  Notably, Petitioner’s policy directs that carts are “placed in any easy accessible centralized location on each floor.”  CMS Ex. 17 at 1.  While it is understandable that there may be a brief delay in initiating ventilation owing to the time it takes to move the emergency cart from its centralized location to a resident’s room, it is an utter failure that Petitioner was unable to ventilate Resident # 202 for eight minutes because it did not maintain a stocked emergency cart.  *See*CMS Ex. 14 at 1.  By failing

**Page 12**

to provide ventilation during the eight minutes of the code preceding EMS’s arrival on scene, Petitioner failed to comply with its own policy requiring that CPR be performed consistent with the AHA guidelines for healthcare professionals.  Petitioner failed to comply with the Medicare participation requirement that it provide basic life support, to include CPR, to residents.  42 C.F.R. § 483.24(a)(3).

The DAB has repeatedly determined that a facility’s failure to comply with its own policy to provide CPR in compliance with professional standards is a failure to meet Medicare participation requirements.  *See North Las Vegas Care Ctr.,* DAB No. 2946 at 6; *Green Valley Healthcare and Rehab.*, DAB No. 2947 at 7.  By failing to ventilate Resident # 202 during the eight minutes of CPR, Petitioner failed to provide basic life support as required by 42 C.F.R. § 483.24(a)(3).

***13.  To the extent CMS determined that loss of NATCEP approval is based on substandard quality of care resulting in a partial extended survey, the determination that the deficiency posed immediate jeopardy to resident health and safety is not clearly erroneous.14***

The parties dispute whether the level of noncompliance is reviewable.  CMS Br. at 11; P. Br. at 9-13.  CMS specifically stated that Petitioner’s loss of its NATCEP approval was based on a partial extended survey resulting from a finding of substandard quality of care; therefore, I will address the immediate jeopardy determination.  CMS Ex. 5 at 4; *see*42 C.F.R. § 498.3(b)(14)(ii).15
  As previously addressed, immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, “serious injury, harm,

**Page 13**

impairment, or death to a resident,” and immediate jeopardy noncompliance with section 483.24(a)(3) amounts to substandard quality of care.  42 C.F.R. § 488.301.

CMS’s determination as to the level of a facility’s noncompliance (to include a finding of immediate jeopardy) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has repeatedly observed 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. 1962 at 11 (2005); *Florence Park Care Ctr.*, 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).

Petitioner failed to ventilate Resident # 202 during eight minutes of CPR, even though its own policy required it to ventilate a resident during CPR, as consistent with the AHA CPR guidelines for healthcare professionals.  CMS Ex. 16 at 1; *see*CMS Ex. 26.  The root of Petitioner’s failure to provide ventilation was its failure to maintain a stocked emergency cart in a centralized location on each floor to which it had “quick access to equipment for utilization in the event of an emergency.”  CMS Ex. 17 at 1.  Petitioner could not obtain a bag valve mask until eight minutes into the code, and as a result, Resident # 202, who was in apparent cardiopulmonary arrest, did not receive the resuscitative measures she desired.

Petitioner argues that resuscitation without ventilation “did not cause or result in” Resident # 202’s death, and therefore, “there is no basis for the finding of substandard quality of care.”  P. Br. at 9.  CPR is only administered to an individual who is suspected of being in cardiac arrest, meaning that the individual’s heart has already stopped beating; although the individual has already died, CPR can improve the chances of the individual’s resuscitation and survival.  *See https://www.cdc.gov/heartdisease/cpr.htm*(last visited September 17, 2021).  Thus, the poor performance of CPR does not cause death, but rather, robs an individual of the sliver of hope for returning to life.

Regardless of whether Resident # 202, who was in very poor health at age 87, was likely to survive, she was entitled to the basic life support in accordance with her wishes that offered her an opportunity for survival.  As Dr. Rothschild opined, it was unlikely Resident # 202 would have a “good outcome.”  CMS Ex. 23 at 4.  But Dr. Rothschild also opined that with appropriate CPR, “there is a chance that [Resident # 202] could have survived the initial resuscitation.”  CMS Ex. 23 at 4.  Although such an outcome may not have led to her walking out of the hospital, her survival through the initial resuscitation may have given her family the opportunity to be at her side.  By failing to ventilate a resident who was in apparent cardiac arrest, Petitioner thwarted the slim opportunity she had for prolonged survival.  A failure to provide potentially life sustaining care amounts to a likelihood of serious injury or death, and Petitioner has not

**Page 14**

shown that CMS’s immediate jeopardy determination is clearly erroneous.  *See Royal Manor*, DAB No. 1990 (2005) (DAB upholding immediate jeopardy for a deficiency involving CPR in which “[i]ncompetence would be a charitable description” of the facility’s CPR efforts).

***14.   A per-instance CMP of $19,500 is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.24(a)(3).***

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3).  These factors include:  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.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  *Id.*  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 above 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.  *See, e.g.*,*Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002).  Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  *Coquina Ctr.*, DAB No. 1860 (2002).

At the time of the survey, the baseline per-instance CMP range was from $1,000 to $10,000 prior to adjustment for inflation.  42 C.F.R. § 488.438(a)(2).  With inflation adjustment, the CMP range at the time of the survey was $2,097 to $20,965.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3; 82 Fed. Reg. 9174, 9182 (Feb. 3, 2017) (setting 2017 inflation adjustments).  CMS imposed a per-instance CMP of $19,500 for the noncompliance with 42 C.F.R. § 483.24(a)(3).  Petitioner does not argue with any specificity that the per-instance CMP is unreasonable, which alone gives reason to sustain it.  *Coquina Ctr*., DAB No. 1860; 42 C.F.R. §§ 488.404, 488.438(f).

Petitioner’s deficiency was at the immediate jeopardy level, and Petitioner disregarded the wishes of a full-code resident when it denied her ventilation during the first eight minutes of CPR.  Such a deficiency is an irreversible error – if Resident # 202 had any chance for survival, Petitioner’s denial of basic life support commensurate with a level expected of health care professionals made that possibility even more remote.  Petitioner

**Page 15**

has not argued that any regulatory factors render the CMP unreasonable, nor has it argued that it is unable to pay the CMP.  A per-instance CMP at the upper end of the penalty range is entirely appropriate, especially considering the severity of the deficiency and Petitioner’s history of recent noncompliance.  In fact, in the year preceding the survey, Petitioner had been cited for two separate deficiencies resulting in actual harm, along with an immediate jeopardy deficiency.  CMS Ex. 3.  A $19,500 per-instance CMP is entirely reasonable for a deficiency involving a failure to provide adequate basic life support to a resident.

IV.  Conclusion

Petitioner was not in compliance with 42 C.F.R. § 483.24(a)(3), and the $19,500 CMP is a reasonable enforcement remedy.  Loss of NATCEP approval is appropriate based on both the CMP imposed and the immediate jeopardy determination, with a finding of substandard quality of care resulting in a partial extended survey.


          /s/
        Leslie C. Rogall

                      Administrative Law Judge
      1. Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7 (State Operations Manual), chap. 7, § 7400.3.1 (Matrix for Scope and Severity); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “J” indicates an isolated deficiency that caused immediate jeopardy to resident health and safety.  Immediate jeopardy exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301. back to note 1
                      2. Substandard quality of care is defined as a deficiency related to an enumerated Medicare participation requirement, to include, 42 C.F.R. § 483.24, that, inter alia, constitutes immediate jeopardy to resident health or safety.  42 C.F.R. § 488.301. back to note 2
                      3. This case was reassigned to me on March 8, 2019. back to note 3
                      4. Because there is no need for a hearing, I need not rule on CMS’s motion for summary judgment. back to note 4
                      5. My findings of fact and conclusions of law are set forth in italics and bold. back to note 5
                      6. Petitioner obtained staff statements on February 28, 2018.  CMS Ex. 15.  Petitioner did not object to the admission of this evidence. back to note 6
                      7. A Dinamap automatically inflates a blood pressure cuff and obtains a blood pressure reading. back to note 7
                      8. Ms. Evans did not report that staff administered supplemental oxygen through the nonrebreather mask, and if so, the oxygen flow rate.  CMS Ex. 15 at 7. back to note 8
                      9. “Ambu bag” is the proprietary name for an apparatus that is used to mechanically ventilate a patient; an Ambu bag is also referred to as a bag valve mask.  I use the terms interchangeably in this decision. back to note 9
                      10. Petitioner’s “emergency cart” (also referred to by Petitioner as a “crash cart”) is stocked with an automated external defibrillator (AED).  CMS Ex. 17 at 1; see CMS Ex. 16 at 1.  Petitioner’s code protocol policy does not address the use of an AED.  CMS Ex. 16. back to note 10
                      11. EMS had no apparent difficulty intubating Resident # 202.  CMS Ex. 12 at 4 (reporting no complications with placement of the endotracheal tube); but see P. Ex. 1 at 2 (physician testimony that Resident # 202 “sustained a delayed acute anaphylaxis reaction to penicillin” and suffered an “anaphylactic cascade”). back to note 11
                      12. Petitioner inexplicably did not initiate CPR until five minutes after an STNA witnessed Resident # 202 become unresponsive.  See CMS Ex. 14 at 1 (noting that the STNA brought a nurse to the room at 8:10 am, and that the nurse called a code at 8:15 am). back to note 12
                      13. As a point of reference for the lengthy period that Resident # 202 was denied ventilation, in eight minutes one could listen to the song Hey Jude and have nearly a minute to spare.  And being that an 8 minute per mile running pace is by no means a blistering pace, it is unclear why it took Petitioner eight minutes to retrieve a bag valve mask from another floor.  Regardless of the reason for such a delay, it is apparent that Petitioner had little or no urgency in obtaining a bag valve mask. back to note 13
                      14. I point out that on page 2 of its request for hearing, Petitioner framed the issue as whether “the survey properly identified the scope and severity of non-compliance, if any.”  Although Petitioner broadly argued that it “disagreed” with “the loss of its nurse aide training program,” it did not raise any specific arguments disputing the loss of its NATCEP.  See 42 C.F.R. § 498.40(b) (content of request for hearing must include “specific issues, and the findings of fact and conclusions of law with which the affected party disagrees”). back to note 14
                      15. I do not disagree with CMS’s statement that the $19,500 PICMP is a basis for loss of NATCEP approval.  CMS Br. at 11.  However, CMS’s initial determination explicitly stated that the loss of NATCEP resulted from a partial extended survey.  CMS Ex. 5 at 4.  Regardless of whether noncompliance with 42 C.F.R. § 483.24(a)(3) resulted in a finding of substandard quality of care, the loss of NATCEP approval is also supported based on the CMP exceeding $10,483, which I address below.  42 C.F.R. § 483.151(b)(2)(iv) (prohibiting approval of a NATCEP for a period of two years if a facility has been assessed a CMP of “not less than $5,000 as adjusted annually”); see 82 Fed. Reg. 9174, 9188 (Feb. 3, 2017) (inflation adjustment of threshold to $10,483, effective February 3, 2017). back to note 15 Back to top
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