Victoria Falls Skilled Nursing and Rehab, DAB CR5657 (2020)

1

DECISION

Petitioner, Victoria Falls Skilled Nursing and Rehab, was not in substantial compliance with program participation requirements from September 30 through October 30, 2015, based on a violation of 42 C.F.R. § 483.252 identified by a survey completed on October 9, 2015.  There is a basis for the imposition of an enforcement remedy.  A per day civil money penalty (CMP) of $6,600 from September 30, 2015 through October 7, 2015, and a per day CMP of $250 from October 8 through 30, 2015, are reasonable.

Page 2

I.  Background

Petitioner is located in Andover, Kansas, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint Stipulation of Undisputed Facts (Jt. Stip.) ¶ 1.  On October 9, 2015, the Kansas Department of Aging and Disability Services (state agency) completed a complaint investigation of Petitioner and found Petitioner not in substantial compliance with five program participation requirements.3

Page 3

CMS notified Petitioner by letter dated November 5, 2015, that based only upon the alleged violation of 42 C.F.R. § 483.25 (Tag F309) CMS was imposing a CMP of $6,600 per day effective September 30 through October 8, 2015,4 and $250 per day CMP effective October 9, 2015, and continuing until Petitioner achieved substantial compliance or its provider agreement was terminated.  CMS also advised Petitioner that it was ineligible to offer a Nurse Aide Training and Competency Evaluation Program (NATCEP) and that a denial of payment for new admissions (DPNA) would be imposed beginning November 12, 2015, and continue until the facility achieved substantial compliance or its provider agreement was terminated.  Jt. Stip. ¶ 2; CMS Ex. 2.

On December 24, 2015, CMS notified Petitioner that a revisit survey determined that it returned to substantial compliance effective October 31, 2015, and the DPNA would not be effectuated.  CMS summarized the CMP as follows:  $6,600 per day for the eight days from September 30 through October 7, 2015, and $250 per day for the 23 days from October 8 through October 30, 2015, a total CMP of $58,550.  CMS did not mention in this notice that the CMP was based on any alleged noncompliance other than Tag F309.  Jt. Stip. ¶ 2; CMS Ex. 1 at 1.

Petitioner requested a hearing before an administrative law judge (ALJ) on December 31, 2015.  This case was docketed as C-16-214 and initially assigned to ALJ Scott Anderson for hearing and decision on January 11, 2016.  An Acknowledgment and Prehearing Order (Prehearing Order) was issued.  The case was then reassigned to me on August 19, 2017.  On November 28, 2017, I notified the parties that the case was scheduled for hearing on August 1, 2018.  On August 1, 2018, a hearing was convened by video teleconference and a transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 18 and Petitioner offered P. Exs. 1 through 9.  All the exhibits were admitted as evidence.  Tr. 25-37.  CMS called Surveyor Kim Barnes, RN (CMS Ex. 17) as a witness.  Petitioner called two witnesses:  Rodney Kevin Bryant, MD, (P. Ex. 5) and Angela Hoffman, Petitioner's Director of Operations (P. Ex. 9).  CMS filed its post‑hearing brief on October 18, 2018 (CMS Br.), and its reply brief (CMS Reply) on November 19, 2018.  Petitioner filed its post‑hearing brief (P. Br.) on October 18, 2018, and its reply brief (P. Reply) on November 19, 2018.

Page 4

II.  Discussion

A.  Applicable Law

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

The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not in substantial compliance with federal participation requirements.  "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary's regulations at 42 C.F.R. pt. 483, subpt. B.  Therefore, a facility may violate a statutory or regulatory requirement, but it is not subject to enforcement remedies if the violation does not pose a risk for more than minimal harm.  The term "noncompliance" refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10-.28, 488.300‑.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

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

Page 5

§ 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility's authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i); see, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, "must be upheld unless it is clearly erroneous."  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

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

Page 6

allegations or a scintilla of evidence.  In this case, I conclude that CMS has made a prima facie showing of noncompliance by a preponderance of the evidence.

B.  Issues

Whether there is a basis for the imposition of an enforcement remedy;

Whether the declaration of immediate jeopardy was clearly erroneous; and

Whether the remedy imposed is reasonable.

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

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

The complaint investigation completed on October 9, 2015, cited Petitioner for noncompliance with five participation requirements.  CMS Ex. 3.  However, the CMS notice dated November 5, 2015, stated that the CMP was imposed based only upon the noncompliance alleged under Tag F309.  CMS Ex. 2 at 1.  CMS agreed at hearing that the CMP was based only upon Tag F309 and that is the noncompliance upon which CMS proceeds.  Tr. 9-11.  The CMP is the only enforcement remedy6 imposed in this case and

Page 7

it is based only upon noncompliance alleged under Tag F309.  Therefore, Petitioner's right to review and my authority to review is limited to Tag F309, the noncompliance for which the CMP was imposed.  42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3(b)(13).

1.  CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25 (Tag F309).

2.  The violation of 42 C.F.R. § 483.25 posed a risk for more than minimal harm and amounted to noncompliance.

3.  Petitioner has failed to rebut the prima facie showing of noncompliance under Tag F309 or establish an affirmative defense.

a.  Facts

Resident 2 is the only resident cited in Tag F309.  She became a resident of Petitioner on August 7, 2013, and was 78 years old when she fell on August 30, 2015.  Jt. Stip. ¶ 3; CMS Ex. 5 at 1‑2.  Resident 2's physician was Kevin Bryant, MD, Petitioner's medical director.

(i.)  Surveyor Findings and Conclusions

CMS placed in evidence the resume of Surveyor Kim Barnes, RN, and her written direct testimony.  CMS Exs. 17, 18.  In her written direct, Surveyor Barnes testified that she drafted the Statement of Deficiencies (SOD) (CMS Ex. 3) in this case.  She testified she cited the violation of 42 C.F.R. § 483.25 (Tag F309) because Petitioner's staff failed to monitor Resident 2's condition following a fall on August 30, 2015, and failed to timely notify the resident's physician of her neurologic changes which resulted in Resident 2's death.  Surveyor Barnes does not identify in her written direct testimony what neurologic

Page 8

changes were not reported or the basis for her opinion that the resident's death was due to the failure to report those changes.  CMS Ex. 18 ¶¶ 7-9.

Surveyor Barnes does, however, identify in the SOD the changes in Resident 2 that were not reported to Dr. Bryant immediately.  CMS Ex. 3 at 10-11.  Surveyor Barnes also testified at hearing that it is a nursing standard to notify a physician when a resident's oxygen saturation (O2 SAT) falls below 90 percent though some facilities adopt a higher threshold for notification.  In her opinion, when Resident 2's O2 SAT fell to 86 percent on September 1, 2015, at about 2:10 am (CMS Ex. 9 at 1) staff should have notified Dr. Bryant.  Tr. 41-43.

Surveyor Barnes described at hearing and in the SOD (CMS Ex. 3 at 11-14) a picture of Resident 2's level of functioning both before and after the resident's fall that is inconsistent with my interpretation of the evidence.  Surveyor Barnes testified that staff told her that prior to the fall Resident 2 was very independent with her activities of daily living (ADLs), including feeding herself, liked to be out of bed, was very active, and ambulated with a walker or wheelchair throughout the facility independently.  She testified staff told her that Resident 2 was very outgoing.  Surveyor Barnes did not specifically state when Resident 2 was as independent and high-functioning as she described.  Tr. 44-45.  My review of the few progress notes CMS and Petitioner offered as evidence shows that Resident 2 had good and bad days over a period of about six months preceding her death.  CMS Ex. 9.  The progress notes are discussed in more detail hereafter.  Surveyor Barnes' characterization of Resident 2's level of functioning after her fall and head injury is also inconsistent with my interpretation of the evidence.  She testified that in her opinion Resident 2 underwent a dramatic change because she was lethargic, remained in bed, was unable to sit up in her chair, and was unable to feed herself at meals.  Tr. 44-45.  Based on Surveyor Barnes' testimony alone one would think Resident 2 was constantly in the state she described between her fall on August 30 and return to the emergency room on September 1, 2015.  However, my reading of the nursing notes (CMS Ex. 9) and review of the Neurological Flow Sheet (CMS Ex. 6), shows that Resident 2 had changes in vital signs and functioning but they occurred briefly and were more subtle than Surveyor Barnes suggests they were.

I accept Surveyor Barnes' opinion that facility staff needs to be particularly vigilant for the possibility of an intracranial bleed after a fall and head injury, particularly for a resident on a blood thinner such as Resident 2 was.  Surveyor Barnes testified that, based on a nursing text,7 the signs staff should monitor for possible intracranial bleed are level

Page 9

of consciousness, pupillary changes, weakness, headache, changes in blood pressure, temperature changes, and loss of responsiveness or unconsciousness.  She opined that no one sign or symptom is most important and it is necessary to look at the whole situation.  She opined it is important to know a resident's baseline function in order to identify and assess changes.  Tr. 46-50.  She opined that the fact that Resident 2 had to be assisted with transferring to her wheelchair, her gait was unsteady, she was unable to sit straight in her chair, and that she had to be assisted back to bed were signs and symptoms of a possible increase in intracranial pressure because the resident's condition varied from her normal level of functioning.  Surveyor Barnes testified that her understanding of the resident's normal functioning or baseline was based on her interviews with staff.  She testified regarding Dr. Bryant's progress note from September 1, 2015.  In her opinion his assessments that Resident 2 was not as responsive as normal, was a little lethargic, and was hanging her head were signs and symptoms of intracranial pressure and so Dr. Bryant should have sent the resident to the hospital at that time.  Tr. 51-54.  On cross-examination Surveyor Barnes agreed that Resident 2's clinical records show that before her fall and head injury she had documented episodes of lethargy, confusion, forgetfulness, refusal to perform ADLs, falling asleep while eating, requiring feeding assistance, poor appetite, tremor, and low O2 SAT.  Tr. 68-76.  Surveyor Barnes also agreed on cross-examination that following Resident 2's low O2 SAT on September 1, 2015, she was seen by Dr. Bryant.  Tr. 90.  Surveyor Barnes expressed no opinion during her testimony or in the SOD that an O2 SAT for Resident 2 below 90 percent posed any risk for harm to the resident.

I note some inconsistency between Surveyor Barnes' testimony and her surveyor notes.  The surveyor testified that staff told her that Resident 2 functioned at a high level prior to her fall on August 30, 2015.  Tr. 44-45.  However, her surveyor notes state that on August 10, 2015, records indicate that Resident 2 was relying more upon staff to assist her with ambulation and she was declining to use her walker.  Resident 2 was also noted at that time to be more confused during the past several days.  Her notes show that a care plan dated June 17, 2015, shows the resident required the assistance of one staff member for ADLs due to unsteadiness.  Resident 2 also had a care plan for falls due to impaired safety awareness due to forgetfulness at times.  CMS Ex. 4 at 1.  Surveyor Barnes interviewed a number of staff members including RN Shirley Sims.  According to

Page 10

Surveyor Barnes' summary of her interview, RN Sims told her that she saw Resident 2 on August 31, 2015.  Resident 2 was more sleepy or lethargic than normal, she was unable to do anything for herself, and just wanted to stay in bed.  However, RN Sims also told Surveyor Barnes that Resident 2 was awake and responded appropriately and, therefore, she did not believe there was a change in level of consciousness of Resident 2.  CMS Ex. 8.  The summary of RN Sims' statements about Resident 2's level of consciousness is consistent with the August 31, 2015 entries on the Neurological Flow Sheet for Resident 2.  CMS Ex. 6.

I find that Surveyor Barnes testimony was generally credible to the extent it was consistent with the clinical records offered as evidence.8   Furthermore, I accept her opinions to the extent that they are consistent with my conclusion that Resident 2's neurological signs recorded after her fall and head injury reflected possible neurological changes that required consultation by Petitioner's staff with Dr. Bryant.  I do not give weight to Surveyor Barnes' opinions to the extent they reflect her conclusion that Resident 2's neurological signs and O2 SAT reflected the occurrence of increased intracranial pressure or that intracranial pressure was the cause of Resident 2's death, which I conclude are beyond the scope of her expertise and based on her potentially inaccurate interpretation of Resident 2's level of functioning both before and after her fall and head injury.  I accept as credible her opinion that signs and symptoms recorded for Resident 2 on August 30, 31, and September 1, 2015, reflect changes from her baseline that were significant given her fall and head injury.

Page 11

(ii.)  Clinical Records

Dr. Bryant ordered in July 2014, that Resident 2 be given oxygen whenever her O2 SAT fell below 89 percent.  Jt. Stip. ¶ 4; P. Ex. 1.  He also ordered at that time that she be sent to the emergency room for evaluation and treatment, but it is not clear from the face of that order whether it applied to only a single incident or whether she was to be sent to the emergency room anytime her O2 SAT fell below 89 percent.  P. Ex. 1.  Dr. Bryant testified at hearing that his July 2014 order was unclear but he believed he intended that Resident 2 only be sent to the emergency room for evaluation one time when he first issued the order.  Tr. 105-06.  The parties stipulated that overnight oximetry testing on August 14, 2015, per the order of Dr. Bryant, showed Resident 2's O2 SAT was below 90 percent 37.1 percent of the time.  Jt. Stip. ¶ 4; P. Ex. 2.

The parties stipulated that Dr. Bryant issued "Laboratory Notification Parameters" applicable to Resident 2.  Jt. Stip. ¶ 6; CMS Ex. 14; Tr. 145-46.  The parameters specified Dr. Bryant was to be notified immediately for a systolic blood pressure (BP) of greater than 200 or less than 90, a diastolic BP of greater than 115; a resting pulse of greater than 130 or less than 55; respirations greater than 28 or less than 10; an oral temperature of greater than 101 or a rectal temperature of greater than 102; or a pulse oximetry (O2 SAT) of less than 90.  CMS Ex. 14 at 1.  The parameters also required, among other things, that Dr. Bryant be notified:  following a fall if there was a new onset of abnormal neurological status or a new onset of confusion; a sudden onset of change in mental status; or a new onset of combative or aggressive behavior, not resolved with environmental interventions, associated with a change in medication or mental status.  Jt. Stip. ¶ 6; CMS Ex. 14 at 2-3.  The parameters bear the dates October 7 and 8, 2015, but it is not clear when they were issued or became applicable to Resident 2.  It is also not clear from the face of the document whether the specific parameters for BP, pulse, respirations, and O2 SAT were supposed to be applied following a fall with a head injury.  CMS Ex. 14.  The parties treat the parameters as if they were in effect before August 30, 2015, when Resident 2 suffered her head injury, and I accept that as true.

Dr. Bryant's progress note shows that he saw Resident 2 on August 18, 2015, in follow-up to her overnight pulse oximetry study.  He listed a past medical history of diabetes, osteoporosis, congestive heart failure, hypertension, diverticulosis, hyperlipidemia, anxiety, coronary artery disease, depression and cerebrovascular accident.  He recorded her vital signs as:  BP 115/46, pulse 66, heart rate 18, temperature 98.9, and O2 SAT as 93.  Dr. Bryant noted no gross sensory or motor deficits.  He noted that she had signs of dementia with a decline in her mentation and confusion.  He also assessed her as having atrial fibrillation and sleep apnea, which required further assessment by a sleep study.  P. Ex. 3 at 1-2.

My earlier statement that Resident 2 had good and bad days during the six months preceding her fall is based on Petitioner's contemporaneous clinical records.  CMS

Page 12

placed in evidence progress notes by Petitioner's staff dated from March 20, 2015, through September 3, 2015.  CMS Ex. 9.  The progress notes show that Resident 2 had a history of being lethargic, variable vital signs, forgetfulness, that she was sometimes slow to assist with her ADLs, and had low O2 SAT consistent with apnea.  A note dated March 31, 2015, at 9:01 a.m., states that Resident 2 was increasingly lethargic, did not want to perform ADLs as well as she did in the past, and that she fell asleep at the dining table.  Her BP was 111/67 and her pulse was 58.  The family was consulted and elected not to treat.  CMS Ex. 9 at 9; Jt. Stip. ¶ 17.  On April 2, 2015, at about 9:45 a.m., staff noted Resident 2 had some bruising with no identifiable cause.  It was noted that the resident's BP was 109/60, her pulse was 58, temperature 96, respirations 15, and O2 SAT was 93 percent.  She was noted to be increasingly lethargic, forgetful, slow to assist with her ADLs, and not eating as well.  CMS Ex. 9 at 8-9.  On April 3, 2015, the resident was noted to be lethargic, she was able to eat breakfast with setup, and asked to go directly back to bed after breakfast.  CMS Ex. 9 at 8; Jt. Stip. ¶ 18.  A dietician attempted to visit Resident 2 on April 9, 2015, and reported that she was very lethargic and sleepy.  CMS Ex. 9 at 7.  A note dated April 16, 2015, states that Resident 2 asked to go to the bathroom and then had to be reminded several times where she was going and where the bathroom was.  CMS Ex. 9 at 7.  On May 11, 2015, it was noted that some evenings the resident was more lethargic and withdrawn.  On May 12, 2015, it was noted that, while the resident could make her needs known, she had periods of confusion, had fallen asleep at the dining table, and had to be cued to eat.  CMS Ex. 9 at 6; Jt. Stip. ¶ 19.  On August 10, 2015, the resident's O2 SAT was 87 percent and staff administered oxygen increasing her O2 SAT to 95 percent; there is no indication Dr. Bryant was notified.  CMS Ex. 9 at 5.  A note dated August 14, 2015, indicates that Resident 2 was checked every hour throughout the night because she was undergoing the continuous pulse oximetry evaluation.  The note states she slept through the night with an O2 SAT of 90 percent and pulse of 66.  CMS Ex. 9 at 5.  A note on August 18, 2015, indicates that the resident was more confused and did not reorient well.  She was seen by Dr. Bryant who gave orders for a sleep study to evaluate Resident 2 for sleep apnea.  CMS Ex. 9 at 4.

(iii.)  Fall and Head Injury

Progress notes dated August 30, 2015, at 3:46 p.m. and 4:33 p.m., indicate that a certified nurse assistant (CNA) found Resident 2 lying on the floor in the doorway of her bathroom.  The resident became combative when staff would not allow her to get up.  She was assessed with a large hematoma to the back of her head, she complained of headache, she remained alert and talkative, BP was 134/87, O2 SAT was 95 percent.  Dr. Bryant was notified and he directed that Resident 2 be sent to the Kansas Medical Center for evaluation and treatment.  CMS Ex. 9 at 2; Jt. Stip. ¶ 9.

Resident 2 was sent to the Kansas Medical Center on August 30, 2015, with a chief complaint of a fall.  The history of present illness noted there was no loss of consciousness, no alterations in mental status or dizziness, and no trouble walking.

Page 13

Resident 2 underwent a CT scan and the radiologist concluded there was no evidence of an intracranial hemorrhage and no evidence of an acute ischemic infarction.  Resident 2 was assessed with right scalp hematoma and soft tissue swelling without underlying skull fracture.  While in the emergency room, Resident 2's vitals were:  heartrate (pulse) 78, BP 153/75, temperature 97.3 and O2 SAT 95 percent.  Upon discharge, Resident 2 was evaluated as stable and her vitals were recorded as:  heartrate 74, BP 179/74, O2 SAT 98 percent.  Resident 2 was sent back to Petitioner's facility on August 30, 2015.  Jt. Stip. ¶¶ 10‑11; CMS Ex. 5.

Petitioner's progress notes indicate that at 7:25 p.m. on August 30, 2015, Resident 2 returned from the emergency room.  Surprisingly, no new orders were issued for the resident.  Neurological checks began according to Petitioner's policy (CMS Ex. 13) and were noted to be within normal limits.  Neurological checks were done at about 3:45 a.m. on August 31, 2015, and were noted to be within normal limits.  At 7:41 a.m. on August 31, 2015, roughly 16 hours after her fall and head injury, it was noted that Resident 2 was transferred to a wheelchair, her gait was unsteady, and she was unable to sit upright in the chair so she was assisted back to bed.  She was also assisted with breakfast.  A note at 11:43 a.m. on August 31, 2015, indicates that Resident 2 was more alert, she was able to feed herself, but she remained in bed.  At 2:10 a.m. on September 1, 2015, Resident 2's O2 SAT started at 92 percent but then dropped to 86 percent.  Oxygen was administered and the note states the O2 SAT was "up" but no an actual measurement is recorded.  The nurse notes do not document that Dr. Bryant was consulted about the fact the resident's O2 SAT dropped below 90 percent, even though notification was required by Dr. Bryant's notification parameters (CMS Ex. 14; Jt. Stip. ¶ 6).  CMS Ex. 9 at 1.  A note at 12:02 p.m. on September 1, 2015, shows new orders for various laboratory tests were received by Petitioner's staff (CMS Ex. 9 at 1), which is consistent with Dr. Bryant's testimony at hearing that he saw Resident 2 during the morning on September 1, 2015 (Tr. 111-15, 130-31).  The note also indicates that Resident 2 used her wheelchair for mobility and sometime on September 1, 2015, she participated in a "sit n swing" exercise and 1 on 1 activity with the Activity Director.  CMS Ex. 9 at 1; Tr. 170-71.

A Neurological Flow Sheet was initiated for Resident 2 on August 30, 2015, at 6:45 p.m.  Neurological checks were documented every 15 minutes between 6:45 p.m. and 7:30 p.m. on August 30; every 30 minutes between 7:30 p.m. and 8:30 p.m. on August 30, 2015; hourly from 8:30 p.m. on August 30 through 12:30 a.m. on August 31, 2015, and then every four hours from 12:30 a.m. on August 31 through 4:30 a.m. on September 1, 2015.  The flow sheet shows that Resident 2's level of consciousness was evaluated as fully conscious throughout all recorded neurological checks.  Her right pupil size was evaluated as 2 millimeters (mm) throughout.  Her left pupil size was evaluated between 6:45 p.m. and 8:30 p.m. on August 30, 2015, as being 1 mm but increased to 2 mm at 9:30 p.m., about six hours after her fall and head injury, and remained 2 mm throughout the documented checks.  Based on the nurse's initials on the form the same nurse did the evaluation between 6:45 p.m. and 8:30 p.m. on August 30, 2015, and a different nurse did

Page 14

the evaluation at 9:30 p.m.  There is no evidence either nurse used a device for pupil measurements but, rather it appears pupil size may have been determined only by reference to a chart on the form, which is very subjective.  The flow chart shows both pupils were equal from 9:30 p.m. through the remainder of the evaluations.  The flow chart also shows both pupils briskly reactive throughout the entire period of recorded neurological checks with one exception discussed hereafter.  The readable portions of CMS Ex. 6 show that the resident's systolic BP ranged from 150 to 164; her diastolic BP ranged from 60 to 108; her pulse ranged from 79 to 99; her respirations ranged from 15 to 20; and her temperature (inferred to be oral) ranged from 96.9 to 100.7.  At 4:30 a.m. on September 1, 2015, her pupils were assessed as equal and briskly reactive, systolic BP was 162, her diastolic BP was 56, her pulse was 88, her respirations were 18, and her temperature was 97 degrees.  Resident 2's neurological signs at 4:30 a.m. on September 1, 2015, compared with those recorded earlier, reflect no marked difference or change.  CMS Ex. 6.  Whether the complete pattern reflects a gradual neurological deterioration of Resident 2 between her fall and her transport to the emergency room on September 1, 2015, which marked the end of her care by Petitioner, requires medical expertise to determine.  I note that Petitioner's Neurological Flow Sheet for Resident 2, does not list O2 SAT as a neurological measure.  CMS Ex. 6.  CMS concedes that a decrease in O2 SAT is not a sign of increased intracranial pressure.  CMS Reply at 4.

The parties stipulated that the Neurological Flow Sheet shows that neurological checks at 8:30 p.m. and at 9:30 p.m. on August 30, 2015, show an increase in Resident 2's temperature from 96.9 to 100.7, her pulse increased from 89 to 95 beats per minute, her blood pressure fell from 161/89 to 151/67, and her left pupil size increased from 1 mm to 2 mm.  The parties did not stipulate that these changes were important or that they marked a significant change in Resident 2's condition or even an insignificant change.  I note that CMS Ex. 6 shows the resident's BP declined further overnight and increased in the morning after the resident would normally be awake; her pulse decreased, then increased, and then decreased again; her respirations decreased and remained the same until her discharge; and her temperature dropped into the 96 to 98 range the next morning and remained unchanged.  Comparing the data documented in CMS Ex. 6 with Dr. Bryant's parameters for his notification (Jt. Stip. ¶ 6; CMS Ex. 14), I observe that none of the measurements for BP, pulse, respirations, or temperature fell outside Dr. Bryant's parameters.  However, those parameters were issued before Resident 2's fall and head injury and Dr. Bryant gave no new orders after the fall or head injury which caused Petitioner to apply its policy on neurological checks.  The Neurological Flow Sheet instructed staff to "Notify MD IMMEDIATELY of signs and symptoms of Intracranial Pressure!!!"  Jt. Stip. ¶ 7 (quoting CMS Ex. 6).  The Neurological Flow Sheet does list the symptoms of intracranial pressure.  CMS Ex. 6.  The parties stipulated that Petitioner's July 12, 2015 policy for neurological checks provides that "failure to monitor changes in a resident's neurological status could lead to serious cognitive and other impairments."  Jt. Stip. ¶ 7.  The parties also stipulated that the policy required staff to notify the physician immediately of any signs and symptoms of intracranial pressure.  Jt.

Page 15

Stip. ¶ 7.  The parties did not stipulate that Petitioner's policy actually listed the signs and symptoms of intracranial pressure.  While the Neurological Flow Sheet obviously lists signs and symptoms that may be used to identify intracranial pressure, it does not specify how the signs and symptoms are to be interpreted.  CMS placed in evidence CMS Ex. 13, which it describes as Petitioner's policy on neurological checks.  CMS Ex. 13, part of which is unreadable due to marking on the page, does not explain how to interpret the signs and symptoms listed on the Neurological Flow Sheet (CMS Ex. 6).  The parties stipulated that as part of the plan of correction following the survey, and apparently with the approval of the state agency, Petitioner's staff was provided in-service training that informed staff that the signs of increased intracranial pressure are:

Earliest Signs:  changes in level of consciousness evidenced by slowing of speech, delay in responding to questions; restlessness, confusion; papillary changes; weakness in one extremity; headache, and "[c]onstant,9 aggravated by movement, increasing in intensity."  Jt. Stip. ¶ 8 citing CMS Ex. 16; Petitioner's Proposed Findings of Fact (P. PFF) ¶ 13.

General Signs:  changes in level of consciousness, papillary changes, decreased motor function (change in motor ability and posturing), headache, seizure, change in vital signs, vomiting, and change in speech.  Jt. Stip. ¶ 8 (citing CMS Ex. 16; P. PFF ¶ 13).

Late Signs:  level of consciousness deteriorates to comatose, decreased respirations or change in pattern (apnea), increase in BP, increase in temperature, bradycardia fluctuating to tachycardia, increased difference between systolic and diastolic BP, projectile vomiting, decorticate or decerebrate posturing followed by flaccidity, and loss of brainstem reflexes such as pupils, corneal, gag, and swallowing.  Jt. Stip. ¶ 8 (citing CMS Ex. 16; P. PFF ¶ 13).

The parties also stipulated that after the survey and as part of the plan of correction the document titled "Physician Notification Summary / When to Call Doctor Addendum" (CMS Ex. 8) was created.  The form instructs staff to contact the physician in the event of acute changes in mental status or post-head trauma if there is a change in hand grip, a change in pupil size greater than 2 mm, a significant change in level of consciousness,

Page 16

and changes of vital signs outside a physician's notification parameters.  This form was also apparently approved by the state agency.  Jt. Stip. ¶ 24.  I note the form provides no definition for significant change or acute change, except to the extent it indicates a significant change is one that is outside physician parameters, and the form is subject to interpretation by staff who have to use it.10   There is no evidence that, before the survey, Petitioner instructed staff how to determine if the signs and symptoms listed on the Neurological Flow Sheet indicated increased intracranial pressure.  The Neurological Flow Sheet used for Resident 2 does instruct staff to rate a resident as lethargic if the resident "responds slowly to verbal stimuli."  CMS Ex. 6 at 1.

The parties stipulated that Dr. Bryant saw Resident 2 on September 1, 2015.  Petitioner placed the progress note in evidence as P. Ex. 6.  According to the parties' stipulation, Dr. Bryant observed that Resident 2 was not as responsive as normal, she was lethargic, she was hanging her head, and she had a tremor in her head and right arm that he had not observed before her fall.  The parties agreed that the progress note indicated that, when asked a question, Resident 2 gave appropriate responses before returning to her state of lethargy.  Jt. Stip. ¶ 16.  The progress note actually states that Resident 2 was not as responsive as she normally is and that she was a "little lethargic."  P. Ex. 6 at 1.  Dr. Bryant stated in the note that Resident 2's dermatitis is "exacerbating again."  P. Ex. 6 at 1.  The resident's BP was recorded as 116/48, pulse 70, respirations 16, temperature 98.9, O2 SAT 94.  Dr. Bryant recorded that his neurological examination revealed no gross sensory or motor deficits.  His assessment was that there was no injury from the resident's fall but there was some "delirium like behavior," and he ordered various laboratory tests to evaluate and treat the delirium.11   P. Ex. 6 at 2.

Nurse progress notes show that several hours after her examination by Dr. Bryant, that is, about 6:35 p.m. on September 1, 2015, Resident 2 was in distress as progress notes show her vital signs were BP 216/170, temperature 101, and heart rate 167.  Dr. Bryant was notified and he directed that Resident 2 be sent to the emergency room.  CMS Ex. 9 at 1; P. Ex. 7.  The next note is dated September 3, 2015, and states that the family visited

Page 17

Petitioner that day and informed staff that Resident 2 died on September 2, 2015.  CMS Ex. 9 at 1; Jt. Stip. ¶ 12.

Resident 2 was admitted to the Wesley Medical Center on September 1, 2015, and discharged on September 2, 2015, upon her death.  Her diagnoses on admission and discharge, included among others, a right frontal intracranial hemorrhage.  The diagnosis was made based on a CT scan of her brain.  The hospital report reflects that Resident 2 was taken to the emergency room on September 1, 2015, due to a decreased level of consciousness and the CT scan was performed.  Upon admission to Wesley, family requested comfort measures only and the resident passed on September 2, 2015.  CMS Ex. 7.

(iv.)  Dr. Bryant's Testimony

Dr. Bryant provided a sworn statement prior to hearing.  He stated that based on his review of Resident 2's clinical record, it was correct not to send the resident to the emergency room the morning of September 1, 2015, based on her neurological checks or the drop in her O2 SAT.  He stated he did not believe there was any significant change in her neurological signs.  He stated that the drop in O2 SAT early on September 1, 2015, was normal and probably due to sleep apnea.  He opined that Petitioner's staff treated the resident's changing condition appropriately.  P. Ex. 4.  He affirmed his opinions as stated in his sworn statement in his written direct testimony.  P. Ex. 5.

At the hearing, Dr. Bryant testified that he was both Resident 2's primary care physician and the facility's medical director.  Tr. 99-100.  Dr. Bryant confirmed that his orders stated that he should be notified for any dip in oxygen saturation and the patient should be transferred to a hospital.  However, he testified that the order was not clear and he believed his intent was that the resident was to be sent to the emergency room one time when he issued the order.  Tr. 105-06, 128-29.  He testified that the overnight oximetry study in August 2015 showed Resident 2 had multiple episodes of O2 SAT below 90 percent and it would not be his practice or procedure to require the facility to contact him every time O2 SAT fell below 90 percent.  He suspected she had sleep apnea and was having her set up for a sleep study.  Dr. Bryant offered no explanation for why he issued an order in July 2014 (P. Ex. 1) for oxygen to be administered for low O2 SAT but it was not until August 2015 that he ordered overnight oximetry and determined a sleep study was probably necessary.  Tr. 104-08, 148; P. Exs. 2, 3.  However, my review is not of what Dr. Bryant did or failed to do as Resident 2's physician.  Dr. Bryant clearly did not treat Resident 2's instances of O2 SAT below 90 percent as an emergency situation that posed a risk for harm to the resident.  Dr. Bryant testified that before her fall, Resident 2 suffered from dementia and episodes of confusion and she was functionally quite debilitated.  He recalled that she had fallen more than once and had episodes of lethargy.  Tr. 109.  He testified that he saw Resident 2 during the morning of September 1, 2015, rather than 2:03 p.m. as indicated in the progress note in evidence as P. Ex. 6.  He was

Page 18

seeing her as a follow-up to her fall on August 30, 2015, and related treatment.  He testified that she seemed lethargic and would rouse to answer questions, which was consistent with her history.  He knew that the CT scan at the emergency room showed no evidence of bleeding so he suspected another cause such as infection and that caused him to order a chest x-ray, blood tests, thyroid testing, urinalysis, a chemistry profile, and two blood cultures.  He believed another CT scan was not appropriate given the resident's neurological checks and the fact that a CT scan had been done on August 30, 2015, that was negative.  At the time of the examination, he was concerned about ruling out an infection or sepsis.  He felt it was possible that a substantial change in condition was occurring and that is why he ordered further testing and evaluation.  He recalled that the examination occurred at Petitioner's facility in the dining room.  Tr. 111-15, 130-31.  He opined that the only change recorded on the Neurological Flow Sheet (CMS Ex. 6) was the change in the pupil size of the left pupil from 1 to 2 making both pupils the same size and he believed that change was not significant.  He testified that a 1 mm change in pupil size is pretty difficult to see.  Tr. 115-16.  He testified that none of the vital signs reported in the Neurological Flow Sheet (CMS Ex. 6) would cause the Petitioner's staff to notify him based on his Laboratory Notification Parameters (CMS Ex. 14).  He testified that none of the measurements recorded on the Neurological Flow Sheet (CMS Ex. 6) indicate the existence of intracranial pressure.  Tr. 117-18.  Dr. Bryant agreed with Petitioner's counsel that Resident 2's O2 SAT was reported to have dropped from 92 to 86 percent and oxygen was administered to bring the O2 SAT back up.  He testified that he saw Resident 2 later that morning sometime before noon.  Tr. 120-21.  He testified that before her fall on August 30, 2015, Resident 2 had a history of being lethargic, confused, and falling asleep at the dining table.  Tr. 121-22, 134-37.  He testified that on September 1, 2015, when Resident 2's blood pressure and temperature fell outside the ranges he specified in his Laboratory Notification Parameters (CMS Ex. 14), Petitioner's staff contacted him, he felt there was a significant change, and he ordered that Resident 2 be sent to the emergency room (P. Ex. 7).  Tr. 123-24.  He testified that there was no significant change indicated on the Neurological Flow Sheet prior to the changes on September 1, 2015, that required Petitioner's staff to notify him.  He saw the resident during the morning of September 1, 2015, he had ordered tests, and based on her vital signs there was no need for notification or transfer.  Tr. 124.  He testified that the Neurological Flow Sheet (CMS Ex. 6) listed the signs and symptoms he used and that are commonly used to assess neurological changes.  He testified that for Resident 2, who had multiple prior episodes of desaturation, a drop in O2 SAT would not be a good sign of intracranial pressure.  Tr. 125.  He testified that when he ordered that Resident 2 be taken to the hospital on September 1, 2015, his concern was that she might be septic.  He did not relate her elevated temperature and blood pressure to possible intracranial pressure.  Tr. 138-39.  He testified on cross-examination that he did not feel that the increase in temperature to 100.7 on August 30, 2015, particularly significant because the temperature did not stay elevated.  CMS Ex. 6; Tr. 150-51.

Page 19

In response to my examination, Dr. Bryant could not say with certainty that Resident 2's intracranial bleed on September 1, 2015, caused her death or that the intracranial bleed was caused by her fall on August 30, 2015.  He assumed all were related based on the timing.  Tr. 155-56.

I find Dr. Bryant's testimony credible.  However, his opinion that Petitioner's staff did not need to consult with him on August 30 and 31, 2015, when there were changes in her vital signs and level of functioning, if not level of consciousness, and on September 1, 2015, when her O2 SAT fell to 86 percent is not given any weight.  The issue before me is whether or not Petitioner satisfied its regulatory duty to consult with Dr. Bryant.  Whether or not Dr. Bryant would have done anything different had he been consulted is not the issue and not particularly relevant.  It would be surprising indeed if he opined differently given his status as the resident's physician and Petitioner's medical director and the fact that staff's failure to consult with him effectively deprived him of the opportunity to direct a different course for Resident 2 before September 1, 2015.

b.  Analysis

The only alleged noncompliance at issue before me is that alleged under Tag F309 for the survey completed on October 9, 2015, as that is the noncompliance for which CMS proposes to impose an enforcement remedy.  Surveyor Barnes alleged in the SOD under Tag F309 that Petitioner:

[F]ailed to adequately assess [Resident 2] after a fall with head injury on 8/30/15.  The head injury resulted in an intracranial hemorrhage . . . .  The resident experienced a change in condition, and the facility's lack of ongoing assessment and prompt response to get medical intervention placed the resident in immediate jeopardy.  The resident expired on 9/2/15.

CMS Ex. 3 at 7.  The allegations that Petitioner failed to adequately assess Resident 2 on an ongoing basis after her fall on August 30, 2015, and failed to obtain medical intervention for the resident are not accurate.  In fact, the evidence shows that Resident 2 was assessed by Petitioner's staff on an on-going basis after her fall and head injury.  The allegation that they failed to adequately assess the resident is unsupported.  There is no evidence that any of the signs and symptoms assessed by staff were in error or incorrectly recorded in the resident's clinical records.  Surveyor Barnes' allegations suggest that her concern was not about failure to assess but, rather, that Petitioner's staff incorrectly diagnosed the cause of Resident 2's signs and symptoms.  However, diagnosing is not staff's duty under the regulatory scheme.  See 42 C.F.R. § 483.20(k)(2).  Rather, as discussed hereafter, Petitioner's staff is required to consult with the resident's physician so that he or she can make accurate and timely diagnoses in order to determine what care

Page 20

and services need to be delivered to the resident as required by 42 C.F.R. § 483.25.  There is no dispute Dr. Bryant saw Resident 2 on September 1, 2015.  P. Ex. 6.  However, there is also no dispute that staff did not consult Dr. Bryant on either August 30 or 31, 2015.  Furthermore, whether, as alleged by Surveyor Barnes, Resident 2's intracranial hemorrhage was actually caused by her head injury is not established by the evidence in the record, though it is highly suspected.  The cause of Resident 2's intracranial hemorrhage and her death are not facts that must be resolved to decide this case.

Based on my reading of the SOD and the CMS briefs (CMS Br. at 4-12; CMS Reply at 1-5) the basis for the alleged noncompliance is actually that Petitioner's staff failed to consult with Resident 2's physician as required by 42 C.F.R. § 483.10(b)(11) when significant changes in Resident 2's condition occurred so that Dr. Bryant could determine what care and services may have been necessary to satisfy the requirement of 42 C.F.R. § 483.25 to deliver necessary care and services.12

The quality of care regulation at 42 C.F.R. § 483.25 requires 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."  Subsections of the regulation set forth specific requirements relating to particular types of care, services, and resident needs.  However, surveyors may cite a deficiency under Tag F309 for failure to comply with the general requirement of the regulation because that language establishes the overarching requirement and executes the congressional mandate for the quality of care provision.  Greenbrier Nursing & Rehab. Ctr., DAB No. 2335 at 5 (2010) (citing Sheridan Health Care Ctr., DAB No. 2178 (2008)).

A facility's failure to provide necessary care and services under 42 C.F.R. § 483.25 can be shown when there is a failure to consult immediately with a resident's physician when the resident experiences a significant change in condition.  Magnolia Estates Skilled Care, DAB No. 2228 at 19 (2009) (citing Laurels at Forest Glenn, DAB No. 2182 at 6, 20 (2008) (affirming a finding by the ALJ that a SNF violated section 483.25 because its nursing staff failed to consult an attending physician when, according to the facility's own protocol, such consultation was necessary)).  Failure to consult with a physician about a

Page 21

clinical condition that required immediate physician consultation and intervention in order to mitigate risk and more serious physical injury is a failure to provide "necessary care and services" to ensure that a resident attains or maintains the highest practicable well‑being.  Magnolia Estates, DAB No. 2228 at 21.

In this case, CMS argues that there was noncompliance with 42 C.F.R. § 483.25 based on a violation of 42 C.F.R. § 483.10(b)(11) because Petitioner failed to consult with Dr. Bryant when Resident 2 had a change in her vital signs and other signs and symptoms, resulting in failure to provide necessary care and services.  The surveyor cited violations of both regulations.  Both citations were based on the same alleged findings of fact by the surveyor.  When the same findings of fact are cited in the statement of deficiency as a basis for violations of both 42 C.F.R. §§ 483.10(b)(11) and 483.25, an ALJ may "properly consider any of those findings relevant both to whether the facility substantially complied with the physician notification requirement at section 483.10(b)(11) and whether it substantially complied with the broader quality of care requirements at section 483.25."  Laurels at Forest Glenn, DAB No. 2182 at 6.

The regulatory requirement that a facility immediately consult a physician when the resident experiences a significant change is set forth in 42 C.F.R. § 483.10(b)(11), which states:

(11)  Notification of changes.  (i)  A facility must immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal respresentative [sic] or an interested family member when there is-

(A)  An accident involving the resident which results in injury and has the potential for requiring physician intervention;

(B)  A significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life‑threatening conditions or clinical complications);

(C)  A need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment); or

(D)  A decision to transfer or discharge the resident from the facility as specified in Sec. 483.12(a).

Page 22

42 C.F.R. § 483.10(b)(11)(i).  It is clear from the regulatory language that the requirement to consult the physician when there is a significant change in condition is not discretionary and requires more than merely informing or notifying the physician.  The regulation also requires notification and consultation "immediately" upon perceiving a significant change in condition of the resident.  The use of the term "immediately" in the regulatory requirement indicates that consultation is expected to be done as soon as the change is detected, without any intervening interval of time.  It does not mean that the facility can wait hours or days before consulting with the physician.  The point of using the word "immediately" is to recognize that in such situations, a delay could result in a situation where a resident is beyond recovery or dies.  The Board has been consistent in its interpretation of the regulation that consultation with a physician must occur immediately, that is, without delay, after a significant change is detected or observed.  Magnolia Estates, DAB No. 2228 at 9; see also, 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991).  The regulation is clear that it is triggered by a significant change.  A significant change is "a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications."  42 C.F.R. § 483.10(b)(11)(i)(B).  Petitioner points out that a federal court held that "the regulation requires consultation with the physician whenever there is a chance that physician intervention is needed."  Claiborne-Hughes Ctr. V. Sebelius, 609 F.3d 839, 844 (6th Cir. 2010).

The specific bases for the citation of noncompliance as urged by CMS before me are that Petitioner:

1.  Failed to consult with Dr. Bryant about the substantial change that occurred on August 30, 2015, at about 9:30 p.m. when Resident 2's temperature increased from 96.9 to 100.7, her pulse increased from 89 to 95, her blood pressure dropped from 161/89 to 151/67, the left pupil changed from 1 mm to 2 mm, and the fact that the right pupil reaction was sluggish but changed to brisk.  CMS Ex. 3 at 10.

2.  Failed to consult with Dr. Bryant regarding a substantial change on August 31, 2015, at about 7:41 a.m. when Resident 2 had an unsteady gait and was unable to sit straight in the chair and had to be transferred back to bed and staff had to assist her with eating breakfast.  CMS Ex. 3 at 10.

3.  Failed to consult with Dr. Bryant regarding a substantial change on September 1, 2015, at about 2:10 a.m. when Resident 2's O2 SAT dropped to 86 percent and staff had to administer oxygen to return the resident's O2 SAT to 92 percent.  CMS Ex. 3 at 10.

There is no dispute that Petitioner's staff did not report any of the three instances to Dr. Bryant.  Normally, these changes in condition in a healthy SNF resident might not be considered significant.  Changes much like these are reflected in Resident 2's nursing

Page 23

notes prior to her fall and head injury.  CMS Ex. 9.  Prior to her fall such changes would probably not be considered significant for Resident 2.  However, after her fall and head injury, Resident 2 was no longer just a resident with multiple diagnoses and various signs and symptoms.  After her fall and head injury, she was at much higher risk for intracranial pressure due to a bleed.  For that reason, Petitioner implemented neurological checks to identify any possible intracranial pressure.  Therefore, changes in any of the items on the list of neurological checks used for Resident 2 were signs of a significant change.

Whether or not the three failures to consult identified in the SOD constitute a failure to deliver necessary care and services as required by 42 C.F.R. § 483.25 has to be determined in the factual context of this case.  For example, the vital signs on August 30, 2015, at about 9:30 p.m. would not trigger the requirement to report to the physician under his Laboratory Notification Parameters (CMS Ex. 14).  However, because the resident had just had a fall and head injury and she was on neurological checks, whether or not reporting was required under the physician's standing order is not the only consideration as it is also necessary to consider Petitioner's regulatory obligation to consult the physician when there is a significant change reflecting either a life threatening condition or a clinical complication.  Given her head injury and the need for neurological checks to monitor for intracranial pressure, any changes reflected a possible life threatening condition or clinical complication that required consultation with Dr. Bryant.

I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25 when it did not immediately consult with Resident 2's physician when she experienced significant changes in condition.  I further conclude that Petitioner failed to rebut the prima facie showing.

The evidence shows that there were significant changes in Resident 2's condition and consultation with Dr. Bryant did not occur immediately.  The Neurological Flow Sheet showed that on August 30, 2015, at 9:30 p.m., about six hours after her fall and head injury, Resident 2's temperature increased from 96.9 to 100.7, her pulse increased from 89 to 95, her blood pressure dropped from 161/89 to 151/67, and the left pupil changed in size from 1 mm to 2 mm.  Surveyor Barnes alleged that the right pupil reaction was sluggish but changed to brisk.  CMS Ex. 3 at 10.  In fact, the nurse recorded on the Neurological Flow Sheet the number "2" that was then scribbled over and the number "1" was written.  It is not possible to determine based on this change whether the right pupil was actually sluggish and changed to brisk or whether the nurse simply corrected an error.  There is no evidence other than the Neurological Flow Sheet that the right pupil was sluggish as Surveyor Barnes alleges.  Rather, the flow sheet indicates that both pupils were briskly reactive during all other assessments.  CMS Ex. 6.  Furthermore, I recognize that all the neurological checks, including BP, temperature, and pulse, were within the limits specified by Dr. Bryant's Laboratory Notification Parameters.  CMS Ex. 14.  I also recognize that the 1 mm change in Resident 2's left pupil size at about 9:30 p.m. on

Page 24

August 30, 2015, would not require physician notification under the procedures adopted by Petitioner and approved by the state agency as part of the abatement of immediate jeopardy, long after Resident 2's significant changes.  CMS Ex. 15.  However, Resident 2 had fallen on August 30, 2015, and sustained a head injury.  Dr. Bryant did not issue orders stating that his Laboratory Notification Parameters applied to Resident 2 subsequent to her fall and head injury.  Petitioner's staff was monitoring Resident 2's neurological signs and symptoms using the Neurological Flow Sheet (CMS Ex. 6) pursuant to Petitioner's policy (CMS Ex. 13).  The Neurological Flow Sheet warned staff to notify the physician immediately of signs and symptoms of intracranial pressure.  The Neurological Flow Sheet does not specifically state which of the items monitored on the sheet are signs and symptoms of intracranial pressure.  However, it is reasonable to infer that they are all signs and symptoms of intracranial pressure as they are all being tracked on the Neurological Flow Sheet.  The sheet also does not indicate that any particular degree of change is required or that there must be changes in more than one area tracked before contacting the physician is necessary.  CMS Ex. 6.  Petitioner's policy provides no more guidance than the Neurological Flow Sheet to determine when to contact the physician about changes to measurements recorded on the Neurological Flow Sheet or whether changes needed to be of a certain magnitude.  CMS Ex. 13.  Resident 2 was in a life threatening situation following her fall and head injury due to the risk for an intracranial bleed.  At 9:30 p.m. on August 30, 2015, just about six hours after her head injury, the resident's drop in blood pressure, increase in temperature and pulse, and the noted change in pupil size, all neurological signs, showed a significant change in the resident's condition.  I conclude that under the circumstances the significant change required consultation with Dr. Bryant.

On August 31, 2015, at 7:41 a.m., a nurse's note was made that stated Resident 2 had an unsteady gait and was unable to sit straight in the chair so she was transferred back to bed and staff had to assist her with eating breakfast.  Movement is also listed as a neurological sign on the Neurological Flow Sheet.  CMS Ex. 6.  Resident 2's unsteady gait and her inability to sit upright were also significant changes given her head injury roughly 16 hours before.  A nurse's note at 11:43 a.m. recorded that Resident 2 was more alert, she was able to feed herself, and remained in bed.  CMS Ex. 9 at 1.  However, the fact that the resident may have recovered at that time, does not mean that Petitioner's staff did not need to consult with Dr. Bryant immediately about the changes observed early that morning.

A note dated September 1, 2015, at 2:10 a.m. recorded that the resident's O2 SAT dropped to 86 percent and staff administered oxygen returning the resident's O2 SAT to 92 percent.  CMS Ex. 3 at 10; CMS Ex. 9 at 1.  There is no dispute that O2 SAT is not generally a neurologic sign, though it is common knowledge that a lack of oxygen can definitely have an adverse impact on brain function.  However, Dr. Bryant had issued specific orders that he was to be notified when O2 SAT dropped below 90 percent.  Although Dr. Bryant may not have wanted to be bothered with a call every time O2 SAT

Page 25

dropped below 90 percent, he never clarified his order.  Furthermore, the drop in O2 SAT roughly 18 hours after a head injury was a change and it was significant because of the resident's risk following the head injury, and physician consultation was required for a treatment decision.

Petitioner argues (P. Br. at 11-12, 18; P. Reply at 2-4) and I agree that none of the changes were significant enough to trigger notification of Dr. Bryant under his Laboratory Notification Parameters.  CMS Ex. 14.  However, the parameters were issued before Resident 2's fall and head injury on August 30, 2015.  There is no evidence that Resident 2's individual disciplinary team (IDT) (42 C.F.R. § 483.20(k)(2)(ii)-(iii)) met and decided whether the existing parameters were adequate or not given the resident's medical state and the need for care and services following her fall.  Because the IDT, which included Dr. Bryant, did not affirm the existing parameters as adequate or issue new parameters, it is necessary to consider whether immediate notification of Dr. Bryant was required under 42 C.F.R. § 483.10(b)(11)(i).  Under 42 C.F.R. § 483.10(b)(11)(i)(B) it is required to consider whether there has been a change in health in either life-threatening conditions or clinical complications.  Under 42 C.F.R. § 483.10(b)(11)(i)(C) it is necessary to consider whether there may be a need to significantly alter treatment.  The duty to consult the treating physician is triggered in either circumstance notwithstanding other notification requirements the physician may have issued.  There is no dispute that an intracranial bleed may be triggered by a resident falling and hitting his or her head.  The parties also do not dispute that an intracranial bleed may be fatal.  Therefore, Resident 2 was in a life threatening condition after her fall and her changes in vital signs, including the questionable change in pupil reaction and the one mm increase in pupil size, indicated a possible deterioration in Resident 2's condition requiring consultation with Dr. Bryant.  Whether Dr. Bryant believed consultation was necessary on August 30 and 31, or early in the morning on September 1, 2015, is not the issue.  There is no question that blood pressure, pulse, respirations, and temperatures are neurological signs and they are listed on Petitioner's Neurological Flow Sheet.  Changes in any of the signs required consultation with Dr. Bryant immediately in order for him to determine whether the changes may have indicated a change in Resident 2's neurological condition and the possibility of a brain bleed.13   If Dr. Bryant had been consulted, he may

Page 26

have acted prior to the resident's clear deterioration that was identified on September 1, 2015, at about 6:35 p.m.  The fact that Dr. Bryant testified that he reviewed the Neurological Flow Sheet later at some point and concluded no significant change was indicated, does not satisfy the requirement under the regulation to consult with him as the treating physician at the time of the change in vital signs on August 30, 2015, so that he could make the determination at that time whether a change in care was necessary such as sending the resident to the emergency room.  The same analysis applies equally to the other changes, specifically Resident 2's unsteady gait, inability to sit upright, and need for feeding assistance on August 31, 2015, at about 7:41 a.m. (CMS Ex. 3 at 10) and her drop in O2 SAT at about 2:10 a.m. on September 1, 2015, that required administration of oxygen (CMS Ex. 3 at 10).

If Resident 2 had not fallen and sustained the head injury on August 30, 2015, the neurological signs would not have been monitored and the analysis would be different.  Petitioner argues that Resident 2 had no change in neurological signs and symptoms on August 31, 2015.  Petitioner is correct that prior to her fall the resident exhibited lethargy, confusion, a tremor, refused assistance with her ADL's and also had instances of low O2 SAT.  P. Br. at 13-15, 18; P. Reply at 4-5.  The difference is that before her fall and head injury, Petitioner and Dr. Bryant had no reason to suspect a possible intracranial bleed.  Once the fall and head injury occurred, neurological checks were being performed specifically to monitor for any possible signs of intracranial pressure or other neurological injury.  To ensure Dr. Bryant had all necessary information to accurately assess what was happening with Resident 2, it is only reasonable to conclude that he needed to be consulted about the changes in neurological signs listed on the Neurological Flow Sheet when they were manifested by Resident 2.  The inconvenience to Petitioner's staff or Dr. Bryant do not outweigh the need for timely and accurate treatment decisions by Dr. Bryant.  I agree with Petitioner that O2 SAT is not listed on the Neurological Flow Sheet and generally may not be considered a neurological sign.  P. Br. at 18-19; P. Reply at 6.  Further, Petitioner is correct that Resident 2 had a history of low O2 SATs with oximetry showing a likelihood of apnea prior to her fall and head injury.  P. Br. at 18; P. Reply at 7.  However, it cannot be argued that low O2 SAT is not a sign or symptom of some dysfunction, impairment, or illness.  Dr. Bryant thought Resident 2 possibly had sleep apnea.  Clearly, given the amount of time it took Dr. Bryant to order a sleep study, he did not consider Resident 2's instances of low O2 SAT to be too significant.  However, it was not for Petitioner's nursing staff to simply assume that the low O2 SAT at about 2:10 a.m. on September 1, 2015, was caused by sleep apnea rather than apnea related to brain injury.  Dr. Bryant was empowered and obliged to make diagnoses and

Page 27

direct care for Resident 2.  However, Dr. Bryant was not immediately consulted regarding signs and symptoms that he may have interpreted differently if he had been consulted.14   On the facts of this record, Dr. Bryant's decision-making was based on less than all the information necessary to make the best clinical judgment.  Petitioner cannot hide behind Dr. Bryant's laboratory parameters issued before the fall and head injury or the fact that he did not blame Petitioner's staff for their failure to immediately consult with him.

Due to Resident 2's age, condition, and potential complications from her fall and head injury, she was at risk for more than minimal harm due to the changes in her condition.  Petitioner's staff clearly knew that Resident 2 was at risk for intracranial bleed as evidenced by the neurological checks performed after she returned from the hospital, and they needed to keep a careful watch on her condition.  The evidence shows that Petitioner's staff did not immediately notify Dr. Bryant about the changes in Resident 2's condition.  Those changes may not have been considered significant under other circumstances.  However, following her fall and head injury Resident 2 was supposed to be on close observation for any signs that her condition was deteriorating due to intracranial bleed.  Rather than immediately consult with Dr. Bryant to ensure he could make a timely judgment as to the level of care Resident 2 required, staff waited to notify him until her vital signs were far beyond her normal and the parameters Dr. Bryant had set before the resident's head injury.

Surveyor Barnes alleged in the SOD a violation of 42 C.F.R. § 483.10(b)(11) (Tag F157) based on Petitioner's failure to immediately consult with Dr. Bryant about Resident 2's changes of condition.  CMS Ex. 3 at 1-7.  The noncompliance cited under Tag F157 is not before me as CMS exercised its discretion and imposed a CMP only as to the noncompliance under Tag F309.  The failure of Petitioner's staff to immediately consult

Page 28

Dr. Bryant is a fact that resulted in a failure to deliver necessary care and services and it is appropriate and necessary to consider that fact in concluding that Petitioner violated 42 C.F.R. § 483.25.

4.  The declaration of immediate jeopardy for the noncompliance under 42 C.F.R. § 483.25 (Tag F309) was not clearly erroneous.

The surveyors cited the noncompliance under 42 C.F.R. § 483.25 (Tag F309) as posing immediate jeopardy to Petitioner's residents beginning on September 30, 2015.  The parties stipulated that the immediate jeopardy was abated on October 8, 2015.  CMS Ex. 3 at 7, 15; Jt. Stip. ¶ 25.  Petitioner's position is that there was no noncompliance and, therefore, no immediate jeopardy.  Petitioner has not argued that, if I conclude that there was noncompliance, CMS's determination of immediate jeopardy was clearly erroneous.  Nevertheless, I consider whether the declaration of immediate jeopardy was clearly erroneous and conclude it was not.

The CMS determination of immediate jeopardy must be upheld unless Petitioner shows the declaration of immediate jeopardy was clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS's determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Human Srvs.,174 F. App'x 932 (6th Cir. 2006); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab. Ctr.– Johnston, DAB No. 2031 at 18-19 (2006), aff'd, Liberty Commons Nursing & Rehab. Ctr.–Johnson v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).  Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous.  Cal Turner Extended Care Pavilion, DAB No. 2384 at 14-15; Liberty Commons Nursing & Rehab. Ctr.–Johnston, 241 F. App'x 76 at 3-4.

"Immediate jeopardy" under the regulations refers to a situation in which 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, 489.3.  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility's

Page 29

provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility's residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, does trigger a right to request a hearing and is subject to review.  42 C.F.R. §§ 488.408(g); 498.3(b)(8) and (13).  Furthermore, the level of noncompliance, i.e. scope and severity, is subject to review only if a successful challenge would:  (1) affect the amount of CMP that may be imposed, i.e. the higher range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14) and (16).  Pursuant to 42 C.F.R. § 498.60(c)(2), in reviewing a CMP, the ALJ must uphold the CMS determination of the level of noncompliance (i.e., the scope and severity), unless it is clearly erroneous.  The phrase "clearly erroneous" is not defined by the Secretary.

Many appellate panels of the Board have addressed "immediate jeopardy."15   In Mississippi Care Center of Greenville, the Board commented:

CMS's determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The "clearly erroneous" standard means that CMS's immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031, at 18 (2006), aff'd, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement

Page 30

regulations, it acknowledged that "distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries."  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  "This inherent imprecision is precisely why CMS's immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference."  Daughters of Miriam Center, DAB No. 2067, at 15 (2007).

DAB No. 2450 at 15 (2012).  The Board's statement that CMS's immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider's burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility's obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  For these reasons, we have revised the

Page 31

regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA [now known as CMS] findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. at 56,179 (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board's decisions in Mississippi Care Center of Greenville, Daughters of Miriam Center, and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the "clearly erroneous standard" would be contrary to the intent of the drafters of the regulation; would significantly limit the review of the determination by an ALJ and the Board; and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Center of Greenville, that panel of the Board states that the clearly erroneous standard means that the "immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one."  DAB No. 2450 at 14.  Similar formulations have been used in other Board decisions when referring to the "clearly erroneous standard."  However, the Board's characterization of the "clearly erroneous standard" in Mississippi Care Center and other cases does not define the standard.  The "clearly-erroneous standard" is described in Black's Law Dictionary as a standard of appellate review applied in judging the trial court's treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black's Law Dictionary 269 (8th ed. 2004).  The Supreme Court has addressed the "clearly erroneous standard" in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact's existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe and Products of Cal., Inc. v. Construction Laborers, 508 U.S. 602, 622 (1993).  The "substantial evidence" standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consol. Edison Co. v. Labor Bd., 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the "clearly erroneous" standard a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been

Page 32

committed.  United States v. United States Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires meaningful review.16   Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  Dumas Nursing and Rehab., L.P., DAB No. 2347 at 19 (2010) (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff'd, Life Care Ctr. of Tullahoma v. Sebelius, 453 F. App'x 610 (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define "likelihood" or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7‑8.  There is a difference between "likelihood" as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences.  Woodstock Care Ctr., DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with "actual harm?"  On the first question, the Board recognized in Yakima Valley Sch., DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term "serious" as used in the definition of immediate jeopardy.17   The

Page 33

Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term "serious."  Id., citing Daughters of Miriam Ctr., DAB No. 2067 at 9.  In Daughters of Miriam Center, the Board discussed that the ALJ attempted to define "serious" as dangerous, grave, grievous, or life-threatening.  The Board noted that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ's definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  Daughters of Miriam Ctr., DAB No. 2067 at 9.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found based on the violation of 42 C.F.R. § 483.25, I have no definite and firm conviction that an error has been committed either in the determination that there was immediate jeopardy or its duration.  Petitioner failed to notify Dr. Bryant immediately about changes in Resident 2's condition that were significant because they occurred after the resident fell and injured her head.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25.  Petitioner's evidence does not show that there was no likelihood for serious injury, harm, impairment, or death, on account of the noncompliance.  Yakima Valley Sch., DAB No. 2422 at 8.  Accordingly, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy based on the violation of 42 C.F.R. § 483.25 was clearly erroneous.

Page 34

5.  A CMP of $6,600 per day from September 30 through October 7, 2015, and $250 per day from October 8 through 30, 2015, for a total CMP of $58,550 is a reasonable enforcement remedy.

The parties stipulated that immediate jeopardy was abated on October 8, 2015, and Petitioner returned to substantial compliance on October 31, 2015.  Jt. Stip. ¶ 25; P. Br. at 11 ¶ 46; P. PFF ¶ 43.  Petitioner disputes that the CMP proposed by CMS is reasonable.  I disagree.

I have concluded that Petitioner violated 42 C.F.R. § 483.25 (Tag F309) from September 30, 2015, through October 30, 2015.  I have also concluded that the declaration of immediate jeopardy related to the violation of 42 C.F.R. § 483.25 from September 30 through October 7, 2015, was not clearly erroneous.  Therefore, CMS has a basis to impose enforcement remedies.

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

My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  Emerald Oaks, DAB No. 1800 at 10; CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

Page 35

Petitioner's noncompliance under Tag F309 was serious.  Petitioner has not shown that the immediate jeopardy related to the violation of Tag F309 was clearly erroneous or abated prior to October 8, 2015.  Petitioner's staff's failure to consult with Dr. Bryant immediately upon identifying changes in Resident 2's signs and symptoms following her fall and injury, prevented Dr. Bryant from identifying possible increased intracranial pressure that posed a high risk for the resident's death.  Whether or not there was increased intracranial pressure at the time of the vital sign changes and whether or not intracranial pressure caused Resident 2's death are not the issues.  I conclude that Petitioner was highly culpable because Petitioner failed to ensure that its staff knew that they should immediately consult with Dr. Bryant, Resident 2's physician, about any changes in her condition after her fall and head injury.  Petitioner did notify Dr. Bryant when Resident 2's vital signs far exceeded the parameters Dr. Bryant had issued before the fall.  However, the notification was far too late.  Had staff actually consulted with Dr. Bryant about changes documented on the Neurological Flow Sheet on August 30, 2015, and in progress notes on August 30 and September 1, 2015, when they occurred, Petitioner's staff would have fulfilled Petitioner's regulatory duty and Dr. Bryant may have taken some action before it was too late for Resident 2.  I have received no evidence related to any past noncompliance or Petitioner's financial condition and ability to pay the proposed CMP.

A CMP that is imposed against a facility on a per day basis falls into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  The lower range of a CMP, $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute 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).  The CMP of $6,600 per day from September 30 through October 7, 2015, the period of immediate jeopardy, is in the middle of the range of CMPs authorized for immediate jeopardy.  The CMP of $250 per day from October 8 through October 30, 2015, the period after immediate jeopardy was abated, is at the low end of the authorized range.  In light of the relevant factors, I conclude that the amount and duration of the CMP are reasonable.

Page 36

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from September 30 through October 30, 2015.  I also conclude that a CMP of $6,600 per day from September 30 through October 7, 2015, and $250 per day from October 8 through October 30, 2015, is a reasonable enforcement remedy.

1. In its request for hearing Petitioner refers to itself as "Victoria Falls Skilled Nursing and Rehab." This case was docketed accordingly. Documents in evidence from the Centers for Medicare & Medicaid Services (CMS) refer to Petitioner as "Victoria Falls." CMS Ex. 1. Publically available information from CMS currently lists Petitioner as "Andover Senior Care, LLC" d/b/a Victoria Falls, National Provider Identifier 1689992752, and Provider Transaction Access Number 175520. https://npiregistry.cms.hhs.gov/registry/provider-view/1689992752.
• back to note 1
2. Citations are to the 2015 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.
• back to note 2
3. The surveyors cited noncompliance based on the following violations:  42 C.F.R. §§ 483.10(b)(11) (Tag F157, scope and severity (s/s) D); 483.25 (Tag F309, s/s J); 483.25(a)(1) (Tag F310, s/s D); 483.25(e)(1) (Tag F317, s/s D); and 483.25(h) (Tag F323, s/s D).  Jt. Stip. ¶ 2; CMS Exhibit (Ex.) 3.The "Tag" is from CMS Pub. 100-07, State Operations Manual (SOM), Appendix PP – Guidance to Surveyors for Long Term Care Facilities (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984).  The "Tag" refers to the specific regulatory provision allegedly violated and CMS policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Social Security Act (Act) and regulations as interpreted in the SOM clearly do have such force and effect.  Ind. Dep't of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary of Health and Human Services (Secretary) may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.Scope and severity levels are used by CMS and a state when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, ch. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is not considered "noncompliance," and which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L indicate deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and which are optional at each level based upon the frequency of the deficiency.
• back to note 3
4. The November 5, 2015 notice stated that the per day CMP of $6,600 accrued through October 8 and was reduced on October 9, 2015.  CMS Ex. 2 at 1.  The CMS notice dated December 24, 2015, stated that the $6,600 CMP accrued from September 30 through October 7, 2015, and was reduced to $250 per day for the period October 8 through 30, 2015.  CMS Ex. 1 at 1.  The parties stipulated that the $6,600 per day CMP accrued from September 30 through October 7, 2015, and the $250 per day CMP accrued from October 8 through 30, 2015.  Jt. Stip. ¶ 2.
• back to note 4
5. "Credible evidence" is evidence that is worthy of belief.  Black's Law Dictionary 596 (8th ed. 2004).  The "weight of evidence" is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
• back to note 5
6. Petitioner was notified in this case that it was ineligible to conduct a NATCEP for two years.  Jt. Stip. ¶ 2; CMS Ex. 2.  Ineligibility to conduct a NATCEP is not an enforcement remedy that either the state agency or CMS have the authority or discretion to impose.  42 C.F.R. § 488.406.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $5,000; or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Petitioner became ineligible to be approved to conduct a NATCEP for two years by operation of law.  I have no authority to declare the ineligibility invalid except to the extent that I conclude that there was no trigger to the ineligibility based on a conclusion that the alleged noncompliance did not occur.  42 C.F.R. § 483.151(b)(2).
• back to note 6
7. In the SOD, Surveyor Barnes refers to Lippincott's 9th edition "Medical-Surgical Nursing Text" as the source of her information for signs and symptoms of increasing intracranial pressure.  CMS Ex. 3 at 14.  CMS has not offered the text as evidence in this case and I am unable to consider it as evidence in support of Surveyor Barnes' testimony.  Tr. 47-49.  However, Surveyor Barnes' list of the signs and symptoms indicative of possibly increasing intracranial pressure are consistent with the testimony of Dr. Bryant and also with the signs and symptoms listed on the Neurological Flow Sheet used for monitoring Resident 2.  CMS Ex. 6.  At any rate, there is little or no dispute as to the signs and symptoms of intracranial pressure.
• back to note 7
8. CMS placed in evidence surveyor notes summarizing the surveyor's understanding of various important clinical records such as Resident 2's minimum data sets, assessments, and care plans.  CMS Ex. 4.  Clinical records for Resident 2 are important to understand her level of functioning.  However, the clinical records are also important to determine the accuracy with which the surveyor viewed the resident's level of functioning and need for care and services in deciding to cite the deficiency.  By not presenting copies of the actual documents, CMS deprived me of an important tool for assessing the credibility of the surveyor's testimony and the weight to accord that testimony.  I further note that the surveyor notes do not specifically mention Dr. Bryant's August 18, 2015 progress notes.  Failure to consider treating physician notes close in time to the incident involving Resident 2 is either a significant oversight on the part of the surveyor or a possible indication of cherry-picking the evidence.  This is particularly true in a case like this where Petitioner argues that it did all it was required to and that the critical decisions were made by the treating physician.
• back to note 8
9. There is obviously a word missing from CMS Ex. 16 and Jt. Stip. ¶ 8.  It is beyond my understanding how CMS Ex. 16 could have been used with state agency approval to train staff as part of the correction of the noncompliance and then stipulated to by the parties, with such an obvious omission.  The omitted word is most likely tremor but that is pure speculation.
• back to note 9
10. I do not consider CMS Exs. 8 and 16, which were created by Petitioner as part of its plan of correction (P. PFF ¶ 42), as admissions of noncompliance or error by Petitioner.  However, based on the fact Petitioner stipulated to the contents of both exhibits, I infer that the documents do reflect an applicable standard of care.
• back to note 10
11. Possible surveyor bias is reflected by the summary of Dr. Bryant's progress note in the SOD.  After describing symptoms the surveyor thinks are consistent with possible brain injury or brain bleed, the surveyor is critical of the physician for not sending Resident 2 to the hospital at the time of his examination.  The surveyor fails to mention that Dr. Bryant assessed no injury from the fall.  CMS Ex. 3 at 10-11.
• back to note 11
12. At hearing, Petitioner agreed that the allegation of failure to consult under Tag F157 and the failure to deliver necessary care and services under Tag F309 as alleged in the SOD are very similar.  Tr. 9-10; CMS Ex. 3 at 1-15.  In fact, the same factual basis is alleged for both deficiencies in the SOD.  Petitioner has not alleged inadequate notice based on the SOD and Petitioner was clearly prepared to defend allegations under both Tag F157 and F309.
• back to note 12
13. Petitioner argues that it is necessary to consider Resident 2's baseline vital and neurologic signs and symptoms prior to her fall on August 30, 2015, to determine if there is a significant change.  P. Br. at 13-15, 19; P. Reply at 5.  Petitioner cites no authoritative source in support of its argument.  On the facts of this case, it is arguably more important to focus upon and consult with the physician regarding changes in neurological signs and symptoms following the known injury rather than ignoring changes in signs and symptoms simply because the resident had similar signs and symptoms in the past.  The regulation however, really grants Petitioner and its staff no discretion in deciding whether to consult or not given the life threatening circumstances of Resident 2's case.
• back to note 13
14. Petitioner points out that when Dr. Bryant saw Resident 2 at Petitioner's facility during the morning of September 1, 2015, he determined not to send the resident to the emergency room because he did not think there was a problem with intracranial pressure.  P. Br. at 16; P. Reply at 5.  Although Dr. Bryant was Petitioner's medical director, he saw Resident 2 in his role as her primary care physician.  Under the circumstances, I do not impute Dr. Bryant's actions and decision-making to Petitioner or find any regulatory violation by Petitioner based on Dr. Bryant's actions or inaction.  Petitioner points out that because Dr. Bryant was both Resident 2's physician and medical director, Petitioner had no option for obtaining a second opinion about Dr. Bryant's orders.  P. Br. at 17; P. Reply at 5-6.  While Petitioner may be correct on this point, it is not the issue.  The issue is whether Petitioner's staff failed to consult with Dr. Bryant so he could make an informed decision about what care and services Resident 2 required to prevent further harm to her following her fall and head injury on August 30, 2015.
• back to note 14
15. Decisions often cited include:  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 6 (2012); Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Daughters of Miriam Ctr., DAB No. 2067; Britthaven of Havelock, DAB No. 2078 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726.
• back to note 15
16. The Board's characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttal presumption, is entirely consistent with the Supreme Court's characterization of the standard.  However, the Court's cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.
• back to note 16
17. The version of Appendix Q of the SOM in effect at the time of this survey also failed to provide surveyors a working definition of the term "serious" that they could use to determine whether harm, injury, or impairment was serious when deciding whether or not to declare immediate jeopardy.  The Act does not define the phrase "immediately jeopardize" and does not introduce the concept of serious harm, injury, or impairment as the basis for finding immediate jeopardy.  Thus, one is not in error concluding that absent a definition of the term "serious" in the Act, the regulations, the SOM, or decisions of the Board, it is essentially up to individual surveyors, and whatever unpublished guidance they receive from their superiors or CMS officials, to exercise their individual discretion and judgment to decide that there was immediate jeopardy, which subjects a facility to the maximum imposable CMPs.
• back to note 17