North Hills Life Care and Rehab, DAB CR5034 (2018)

I.Background

The Social Security Act (Act) establishes requirements for SNF participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions. See 42 U.S.C. § 1395i-3; 42 C.F.R. parts 483 and 488.1 To participate in the Medicare program,

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an SNF must maintain substantial compliance with program participation requirements. In order to be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with program participation requirements. 42U.S.C. § 1395aa(a); 42 C.F.R. § 488.10. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements, and these regulations specify the enforcement remedies that can be imposed. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. At the time of the survey, a per-instance CMP, which is the remedy imposed against Petitioner, could range from $1,000 to $10,000.2 42 C.F.R. § 488.438(a)(2).

If CMS imposes a CMP based on noncompliance, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy. 42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

The Arkansas Office of Long Term Care (survey agency) completed a recertification and complaint survey at Petitioner’s facility in Fayetteville, Arkansas, on March 4, 2016. CMS Exhibits (Exs.) 1, 4. The surveyors cited five deficiencies with Medicare program requirements,3 to include noncompliance with 42 C.F.R. § 483.25, cited as Tag F309

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(quality of care), at the scope and severity level of “J” based on immediate jeopardy4 to resident health or safety, which is the sole deficiency challenged in the request for hearing.5 CMS Ex. 4. The state agency notified Petitioner of its findings in a letter dated March 14, 2016.6 See CMS Ex. 1 at 1. In a letter dated April 7, 2016, CMS concurred with the state agency’s previous findings. CMS Ex. 1 at 1. CMS determined that immediate jeopardy had been abated, but that Petitioner remained out of substantial compliance. CMS Ex. 1 at 1. At that time, CMS imposed a $6,000 per-instance CMP for Petitioner’s noncompliance with 42 C.F.R. § 483.25 (Tag F309), which is the deficiency that is the focus of this decision.7 CMS Ex. 1 at 2.

Petitioner submitted a request for hearing dated June 2, 2016. I issued an Acknowledgment and Pre-Hearing Order (Pre-Hearing Order) on June 8, 2016, establishing a schedule for filing briefs and pre-hearing exchanges. CMS filed a pre‑hearing brief (CMS Br.) and 34 exhibits (CMS Exs. 1-34), and Petitioner filed a pre‑hearing brief (P. Br.) and 31 exhibits (P. Exs. 1-31). Pursuant to Section 8 of my Pre‑Hearing Order, CMS requested an opportunity to cross-examine Petitioner’s three witnesses who submitted written direct testimony. CMS also objected to the admission of P. Exs. 4, 13-14, 20-21, and 24-25 on the basis of relevance.

I convened a telephonic pre-hearing conference on November 21, 2016. Shortly thereafter, CMS withdrew its request for cross-examination and I granted the parties’ oral

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request for an opportunity to submit additional briefing. Both parties submitted additional briefing pursuant to my December 8, 2016 Order (CMS Supp. Br.; P. Supp. Br.), followed by reply briefs (CMS Reply; P. Reply).

In my order dated December 8, 2016, I ruled on CMS’s evidentiary objections. At that time, I sustained CMS’s objections to P. Exs. 4, 13, and 14 because Petitioner had not demonstrated that those documents were relevant, and I noted that Petitioner had not cited to this evidence in its brief and its witnesses had not addressed this evidence in their written testimony. I overruled CMS’s objections to P. Exs. 20, 21, 24, and 25, based on the apparent reliance on these documents by one of Petitioner’s witnesses. Therefore, CMS Exs. 1-34 and P. Exs. 1-3, 5-12, and 15-31 have been admitted into the evidentiary record. The record is closed, and the case is ready for a decision on the merits.

II.Issues

The issues presented are:

1. 1.Whether Petitioner failed to be in substantial compliance with Medicare program participation requirement pursuant to 42 C.F.R. § 483.25.
2. 2.If so, whether the $6,000 per-instance CMP is reasonable.

III.Discussion8

1. A.The facility did not ensure that Resident # 15 received, and that it provided, the necessary care and services for her to attain or maintain the highest practicable physical, mental, and psychosocial well-being as required by 42 C.F.R. § 483.25.
   1. i.Factual background, relevant law, and facility policies

      Resident # 15, who was 83 years old at the time of the survey, was first admitted to the facility on December 31, 2015, following surgery for a left hip fracture. P. Exs. 1 at 1; 15 at 6; CMS Ex. 21 at 1. On January 11, 2016, the facility transferred Resident # 15 to an acute care hospital for evaluation of a possible cerebrovascular accident (CVA). CMS Ex. 21 at 13, 15. Following her discharge from the acute care hospital on January19,2016, Resident # 15 returned to the facility. P. Ex. 1 at 1. In addition to her fractured left hip, Resident # 15 has a medical history that is significant for muscle wasting and atrophy of the right upper arm and lower extremities, dysphagia, abnormalities of gait and mobility, hypertension, ventricular tachycardia, cognitive

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      communication deficit, hypo-osmolality, hyponatremia, urinary retention, urinary tract infection, unsteadiness on feet, and neuropathy. P. Ex. 1 (Resident # 15’s admission record).

   2. The facility performed a Minimum Data Set (MDS) assessment of Resident # 15 on January 7, 2016. CMS Ex. 17 at 1-38. The facility assessed that Resident # 15 had cognitive impairments, but was able to make herself understood and was able to understand others. CMS Ex. 17 at 4-5. Resident # 15 was assessed to be in need of extensive assistance with bed mobility, transfers, walking, moving between locations in her unit, dressing, and toilet use. CMS Ex. 17 at 13-14. The assessment determined that Resident # 15 was not steady, and she was only able to stabilize herself with staff assistance when moving from a seated to standing position, walking, turning around, moving on and off the toilet, and transferring between her bed and chair or wheelchair. CMS Ex. 17 at 14. The facility determined that Resident # 15 had a limited range of motion in one of her lower extremities, and that she used a walker and a wheelchair. CMS Ex. 17 at 14.

      Following Resident # 15’s readmission on January 19, 2016, after her hospitalization for a CVA, Petitioner conducted another MDS assessment on February 2, 2016. CMS Ex. 18. Resident # 15 exhibited cognitive and communication deficits, and was assessed as having a Brief Interview for Mental Status (BIMS) score of 3.9 CMS Ex. 18 at 7-8. Resident # 15 continued to require extensive assistance, and she normally used a wheelchair for locomotion. CMS Ex. 18 at 9-10.

      Petitioner’s staff assessed Resident # 15’s risk for falls on February 5 and 6, 2016. The facility assigned a fall risk score of 75, which corresponds to a high risk of falling. P. Ex. 3. Petitioner reviewed and updated Resident # 15’s care plan based on her risk of falls. P. Ex. 2 at 3, 4, 7-8.

      At approximately 10:00 pm on February 5, 2016, a certified nurse aide (CNA) entered Resident # 15’s room to empty her Foley catheter and found her on the floor next to her bed, leaning against the alarm pad and her bed. CMS Ex. 21 at 20. Resident # 15 was “confused” and unable to give a statement, and she was incontinent of bowel. CMS Ex. 21 at 20, 26. Facility staff conducted a physical and visual examination of Resident # 15. CMS Ex. 21 at 20, 34. While progress notes are silent for any injuries, the incident investigation report states that Resident # 15 had “an abrasion to her right

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      back” and “a reddened area to her right back from scapula to hip.” CMS Ex. 21 at 26, 34. Resident # 15 was assisted off the floor and back to bed with the assistance of two CNAs using a gait belt, and she did not complain of pain during the transfer. CMS Ex. 21 at 26, 34. Resident # 15 had “no acute distress,” and her vital signs were “stable.” CMS Ex. 21 at 34. “[I]mmediate interventions” included providing incontinence care and repositioning Resident # 15’s bed sheet and alarm pad, which had come off the mattress. CMS Ex. 21 at 20. Staff also initiated recurring neurological checks, which appear to have started at 10:00 pm and continued through 5:00 am on February 6, 2017. P. Ex. 26 at 1-23; CMS Ex. 20 at 45-68. The neurological assessment forms document that Resident # 15 did not report any pain. CMS Ex. 20 at 45-68.

      Facility staff notified Resident # 15’s physician at 10:19 pm that same night. CMS Ex. 21 at 28. Progress notes indicate that facility staff contacted the physician’s call service and spoke to the nurse on call; the record does not evidence that facility staff spoke directly with Resident # 15’s physician. CMS Ex. 21 at 20; P. Ex. 15 at 3.

      Resident # 15 fell again on February 6, 2016. At approximately 3:30 pm, a CNA heard Resident # 15’s wheelchair alarm when she was walking past Resident # 15’s room. CMS Ex. 20 at 1. The CNA found Resident # 15 “lying in the floor in between the bathroom door and wheelchair lying on her [right] side in front of bathroom floor.” CMS Ex. 20 at 1. Immediate interventions included orienting Resident # 15, who was “too confused to make a statement,” and instructing her to use the call light when she needed assistance. CMS Ex. 21 at 20. Resident # 15 had a bluish/purple “ping pong ball sized knot”10 on her forehead, and she complained of right-sided hip pain of a level “10” in severity. Staff took her vital signs – blood pressure, pulse, respirations, and temperature. CMS Ex. 21 at 20. Two facility employees, using a gait belt, assisted Resident # 15 from the floor to her wheelchair, and then to a recliner with the foot rest in the up position. CMS Exs. 20 at 1; 21 at 20.

      Progress notes report that the facility contacted an “on call nurse” at 3:30 pm (CMS Ex.21 at 20), but an incident report documents that the facility notified an on-call physician at 3:15 pm. CMS Ex. 20 at 5.

      The facility initiated recurring neurological checks of Resident # 15 at 3:30 pm. CMS Ex. 20 at 7-21. The facility apparently utilized pre-scheduled fillable computerized forms for these assessments, as evidenced by the inclusion of largely blank forms that correspond to assessments that would have taken place, but did not, due to Resident # 15’s transfer to the acute care hospital at approximately 6:30 pm. CMS Ex. 20 at 22-42. The neurological assessments yielded the following information:

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      3:30 pm (“First Fifteen Minute Assessment”)

      With the exception of “Nonverbal expressions of pain?”, all fields of the form were completed, to include: temperature, pulse, blood pressure, respirations; a “confused” level of consciousness and orientation to person (both consistent with baseline); pupils 2mm, and equal and reactive to light; pain level of “6”with verbal expressions of pain; movement/sensation/grip (as applicable) of all four extremities intact; and, a note/comment of a “ping pong ball on for[e]head mid middle – Purple/Blue area.” CMS Ex. 20 at 7-9.

      3:45 pm (“Second Fifteen Minute Assessment”)

      All fields of the template form were completed, to include: temperature, pulse, blood pressure, and respirations; a “confused” level of consciousness and orientation to person (both consistent with baseline); pupils 2mm, and equal and reactive to light; pain level was “10” with verbal expressions of pain but no nonverbal expressions of pain; complaints of right hip pain; movement/sensation/grip (as applicable) of all four extremities intact; and, a note/comment that Resident # 15 continued to have right hip pain and a knot to the forehead. CMS Ex. 20 at 9-11.

      4:00 pm (“Third Fifteen Minute Assessment”)

      All fields of the form were completed, to include: temperature, pulse, blood pressure, and respirations; a “confused” level of consciousness and orientation to person (both consistent with baseline); pupils 2mm, and equal and reactive to light; pain level of “5” with both verbal and nonverbal expressions of pain; movement/sensation/grip (as applicable) of all four extremities intact; and, a note/comment that Resident # 15 “[c]ontinues to [complain of] severe pain”11 to her right hip and that she had a hematoma on her head. CMS Ex. 20 at 11-13.

      4:15 pm (“Fourth Fifteen Minute Assessment”)

      With the exception of blood pressure, all fields of the form were completed, to include: temperature, pulse, and respirations; an “alert” level of

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      consciousness and orientation to person (both consistent with baseline12); pupils 2mm, and equal and reactive to light; pain level of “10” with verbal expressions of pain but no nonverbal expressions of pain; movement/sensation/grip (as applicable) of all four extremities intact; note/comment that Resident # 15 “[c]ontinues to have severe pain” of the right hip.  CMS Ex. 20 at 13-14.

      4:45 pm (“First Thirty Minute Assessment”)

      With the exception of blood pressure and “Nonverbal expressions of pain?”, all fields of the form were completed, to include:  temperature, pulse and respirations; a “confused” level of consciousness and orientation to person (both consistent with baseline); pupils 2 mm, and equal and reactive to light; pain level of “10” with verbal expressions of pain (with no notation for nonverbal expressions of pain); movement/sensation/grip (as applicable) of all four extremities intact; note/comment that Resident # 15 “[c]ontinues to have severe pain” of the right hip.  CMS Ex. 20 at 14-16.

      5:15 pm (“Second Thirty Minute Assessment”)

      With the exception of blood pressure, all fields on the form were completed, to include: temperature, pulse, and respirations; a “confused” level of consciousness and orientation to person (both consistent with baseline); a pain level of “10” with both verbal and nonverbal expressions of pain; movement/sensation/grip (as applicable) of all four extremities intact; and, a note/comment that Resident # 15 reported “increasing pain” to the right hip. CMS Ex. 20 at 16-18.

      5:45 pm (“Third Thirty Minute Assessment”)

      All fields on the form are blank. CMS Ex. 20 at 18-19.

      6:15 pm (“Fourth Thirty Minute Assessment”)

      With the exception of field addressing whether the level of orientation was a change from baseline, all fields on the form are blank.13 At that time,

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      Resident # 15 was no longer oriented to person, which was reported to be a change from her baseline level of orientation. CMS Ex. 20 at 19-21.

      Resident # 15’s physician’s records document that Petitioner called at some point on February 6, 2016, and a physician, Dr. Ellis, conferenced with the licensed practical nurse (LPN) caring for Resident # 15 and ordered her to be transferred to the emergency department for evaluation. 14 P. Ex. 15 at 1. Progress notes document that at 6:30 pm that same day, Resident # 15’s on-call physician ordered that she be transferred to the hospital for evaluation and treatment “if necessary [related to] chronic pain to right hip from previous fall this evening and hematoma to for[e]head.” CMS Ex. 21 at 21.15

      Central EMS performed an assessment at 6:30 pm, and recorded that Resident # 15 had a blood pressure of 190/80, a pulse of 100, and pulse oxygen of 94. P. Ex. 7 at 1. Central EMS also reported that Resident # 15’s pupils were dilated to 3mm. P. Ex. 7 at 1. Central EMS observed that Resident # 15 was holding her right side and there was “minor shortening of the [right] leg.” P. Ex. 7 at 2. During the .3 mile transport, Resident # 15 was alert, but was unable to communicate “from dysphagia after a CVA.” P. Ex. 7 at 2.

      An emergency department record reports that Resident # 15 appeared “in distress due to pain.” CMS Ex. 23 at 5. Physical examination included “signs of trauma,” to include shortening of the right leg and bruising of the knee. CMS Ex. 23 at 7. An x-ray of her right hip revealed a “right intertrochanteric hip fracture.” CMS Ex. 23 at 14. On February 8, 2016, Resident # 15 underwent surgical repair of her hip fracture. CMS Ex. 23 at 18-19. Upon discharge, Resident # 15 “did not want to go back to the same facility.” CMS Ex. 23 at 16.

      The general quality of care that Petitioner must provide its residents is addressed in the Secretary’s regulations, along with its own policies. The standard that is established by regulation is, as follows:

      Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

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      42 C.F.R. § 483.25.

      In order to promote the goal of providing the necessary care and services to attain or maintain the highest level of well-being, the facility had implemented several relevant policies. CMS Exs. 27-30. Petitioner also utilized the Interventions to Reduce Acute Care Transfers (INTERACT) protocol, which it identifies as its “standard of care.”16 P. Exs. 18-20.

      Petitioner had an “Accidents and Incidents – Investigating and Reporting” policy.17 CMS Ex. 27. This policy states that all accidents or incidents involving residents, employees, visitors, or vendors occurring on facility premises are required to be investigated and reported to the Administrator. The policy directs the “nurse supervisor/charge nurse” and/or the supervisor to “promptly initiate and document investigation of the accident or incident” and complete an incident report/accident form within 24 hours. Investigation reports must include the following information regarding an accident/incident: the circumstances, date, time and location; the nature of the injury/illness; the names of any witnesses and their accounts; the injured person’s account; the time of notification of the injured person’s attending physician, along with the physician response and instructions; the date/time of family notification and by whom; the injured person’s condition, including vital signs; and the disposition of the injured person. CMS Ex. 27.

      Petitioner’s policy, “Falls – Clinical Protocol,” addresses the identification and assessment of residents who are at risk for falls and directs necessary actions in the event of a resident fall. CMS Ex. 28 at 1-3. The policy instructs that falls must be documented, to include providing information such as the circumstances of a fall and whether the fall was witnessed. The facility must attempt to define possible causes within 24 hours of the fall, and medical review must be obtained when a fall is medical in origin, there are repeated falls despite interventions, or the cause of the fall is unclear. CMS Ex. 28 at 2. The policy requires interventions to prevent subsequent falls and to address the risks of the consequences of falling. CMS Ex. 28 at 2. The policy directs that “[t]he staff, with the physician’s guidance, will follow up on any fall with associated injury until the resident is stable and delayed complications such as late fracture or subdural hematoma have been ruled out or resolved.” CMS Ex. 28 at 3. The policy cautions that “[d]elayed complications such as late fractures and major bruising may occur hours or several days

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      after a fall, while signs of subdural hematomas or other intracranial bleeding could occur up to several weeks after a fall.” CMS Ex. 28 at 3. The policy directs staff and physicians to monitor and document a resident’s response to interventions. CMS Ex. 28 at 3.

      Petitioner’s “Falls and Fall Risk, Managing” policy directs staff, “[b]ased on previous evaluations and current data, [to] identify interventions related to the resident’s specific risks and causes to try to prevent the resident from falling and to try to minimize complications from falling.” CMS Ex. 28 at 4. Staff, working with the attending physician, must identify and implement appropriate interventions. The attending physician, in conjunction with the consultant pharmacist and nursing staff, will identify and adjust a resident’s medications that may be associated with an increased risk of falling. CMS Ex. 28 at 4.

      Petitioner’s “Change in a Resident’s Condition or Status” policy directs facility staff to “promptly notify the resident, his or her Attending Physician, and representative (sponsor) of changes in the resident’s medical/mental condition and/or status (e.g., changes in level of care, billing/payments, resident rights, etc.).” CMS Ex. 29 at 1. The policy lists numerous circumstances that trigger notification of a resident’s physician, to include an accident or incident involving the resident, a discovery of injuries of an unknown source, a significant change in the resident’s physical/emotional/mental condition, a need to alter the resident’s medical treatment significantly, and a need to transfer the resident to a hospital/treatment center. CMS Ex. 29 at 1. When a significant change occurs, the “nurse supervisor/charge nurse” must document any information concerning it in the resident’s medical record, and staff must conduct a comprehensive assessment. CMS Ex. 29 at 2.

      Petitioner’s “Neurological Assessment” policy, as relevant here, is to be applied following an unwitnessed fall or a fall or other accident or injury with suspected head injury. CMS Ex. 30. The policy notably requires that “[w]hen assessing neurological status, always include frequent vital signs,” and directs that “particular attention” be paid to a widening pulse pressure because it may indicate the presence of intracranial pressure. CMS Ex. 30 at 1. Further, the policy directs that “[a]ny change in vital signs or . . . neurological status in a previously stable resident should be reported to the physician immediately.” CMS Ex. 30 at 1. The policy instructs staff to assess, and document, the following information obtained from neurological checks at the frequency specified by the physician or in the falls protocol: orientation to time, place and person; the resident’s patterns of speech and speech clarity; vital signs (temperature, pulse, respirations, and blood pressure); pupil reaction; motor ability; sensation of extremities; gag reflex (with a tongue depressor, if safe to do so); and facial drooping (by asking resident to smile). CMS Ex. 30 at 1-2. The policy directs staff to “[n]otify the physician of any change in a resident’s neurological status.” CMS Ex. 30 at 2.

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      Petitioner also utilized the “INTERACT standard of care,” which Petitioner contends set an appropriate standard of care for the treatment of Resident # 15 following her two falls. P. Exs. 18-20; P. Br. at 2 (“[Petitioner] followed fall protocols in regard [to] [Resident # 15] and appropriately assessed [Resident # 15] based on [the INTERACT] standard of care.”); P. Br. at 7 (“Petitioner informed the . . . surveyors that it utilized the INTERACT standard of care in assessing residents who experience a change in condition.”). Petitioner submitted evidence that the INTERACT care path for falls directs staff to obtain the following after a fall: temperature, blood pressure, pulse, apical heart rate (if the pulse is irregular), respirations, oxygen saturation, and finger stick glucose test (if the resident is a diabetic), and that if any vital sign was not within a prescribed range, then “immediate notification” 18 of the physician/nurse practitioner/physician’s assistant should occur.19 P. Ex. 19. The INTERACT care path further specifies that, even if vital signs are within normal limits, the physician/nurse practitioner/physician assistant must be immediately notified in the event of either suspected fracture or head trauma.20 P. Ex. 19.

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   3. ii.Analysis
      1. 1.Petitioner failed to conduct and document assessments in accordance with its Neurological Assessment policy after Resident # 15 fell on February 6, 2016, and Petitioner failed to provide the necessary care and services to Resident # 15.

         CMS contends that Petitioner failed to provide necessary care and services to Resident # 15, as required by 42 C.F.R. § 483.25, after she fell on consecutive days, because its staff failed to conduct required assessments and immediately notify her physician, as required by its own written policies.

         The Departmental Appeals Board (DAB) has concluded that the language of 42 C.F.R. § 483.25 not only requires skilled nursing facilities to furnish the care and services set forth in a resident’s care plan but also to implement doctors’ orders, monitor and document the resident’s condition, and follow its own policies. See, e.g., Alexandria Place, DAB No. 2245 at 7-8 (2009) (upholding a deficiency when a petitioner did not provide care in accordance with a doctor’s order); Oxford Manor, DAB No. 2167 at 5-6 (2008) (affirming an ALJ’s reliance on a facility’s policy as evidence of the standard of care the facility expected its staff to provide); Spring Meadows Health Care Ctr., DAB No. 1966 at 18 (2005) (quality of care provision also implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality “since the regulations elsewhere require that the services provided or arranged by the facility must meet such standards.”).

         As previously discussed, Petitioner’s policy for neurological evaluations requires its staff to perform repeated neurological checks when a resident has an unwitnessed fall. CMS Ex. 30 at 1 (“Perform neurological checks with the frequency as ordered or per falls protocol,” and “When assessing neurological status, always include frequent vital signs.”). After Resident # 15 fell on February 6, a nurse conducted the initial neurological assessment at 3:30 pm. CMS Ex. 20 at 7-9. The facility provided relatively complete documentation, as required by the fields included in the template assessment form, when it conducted the first three “fifteen minute” neurological checks at 3:30 pm, 3:45 pm, and 4:00 pm; a nurse recorded Resident # 15’s vital signs and assessed Resident # 15’s orientation, level of consciousness, pupils, and level of pain. CMS Ex. 20 at 7-13.

         However, the record shows that the repeated neurological checks were incomplete beginning with the 4:15 pm assessment. Although the staff was required to frequently obtain vital signs and the facility form used to document neurological checks directed staff to obtain and vital signs at each neurological check, the neurological checks

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         beginning at 4:15 pm did not include blood pressure readings. CMS Ex. 20 at 13-18. This is particularly concerning because the facility’s Neurological Assessment policy stresses that staff should pay “[p]articular attention” to widening pulse pressure in repeated blood pressure readings because it can signal intracranial pressure. CMS Ex. 30 at 1. Further, although a 5:45 pm “Third Thirty Minute Assessment” is of record, the form is blank, and therefore, there is no documentary evidence establishing that Petitioner monitored Resident # 15 during this time period.21 CMS Ex. 20 at 18-19. At the time of the 6:15 pm neurological check, the form is once again incomplete, and only records that Resident # 15 exhibited a change from her baseline orientation. CMS Ex. 20 at 19-21. Based on the foregoing, Petitioner’s staff failed to perform complete neurological checks of Resident # 15 after she fell on February 6, 2016, as required by Petitioner’s own policy.22

         After Resident # 15 fell on February 6, it was incumbent upon Petitioner’s staff to monitor her closely, particularly because the fall was unwitnessed and she suffered head trauma. However, Petitioner repeatedly failed to obtain and record all assessment data required by its own policy. As a result, Petitioner failed to provide the necessary care and services to Resident # 15.

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      2. 2.Based on its failure to immediately consult Resident # 15’s physician when she experienced a change in condition on February 5 and 6, 2016, Petitioner failed to provide the necessary care and services to Resident # 15.

         With respect to physician notification, CMS argues that Petitioner failed to immediately notify Resident # 15’s physician after Resident # 15 fell on February 5 and 6, and therefore did not comply with its policy pertaining to a change in a resident’s condition. CMS argues that Petitioner failed to document the physician’s orders in the incident report, and it therefore did not comply with its policy pertaining to the investigation and reporting of accidents and incidents.

         Petitioner argues that its staff immediately notified the on-call physician for Resident # 15’s attending physician, via an on-call service, after Resident # 15 fell on both February 5 and 6. P. Br. at 11, 16. According to Petitioner, a physician call service is “an acceptable standard of practice . . . for long term care centers,” and therefore, it complied with its policy. P. Reply at 14, 16.

         I observe that incident reports regarding Resident # 15’s falls are inconsistent with the contemporaneous progress notes that document the notifications made following Resident # 15’s falls. The incident report for the February 5 fall states that staff notified Resident # 15’s physician at 10:19 pm. CMS Ex. 21 at 28. However, according to the progress notes, staff contacted the “[o]n call nurse” (CMS Ex. 21 at 20), which is consistent with the “Nsg-I&A Note” that reports that the facility performed the following notification: “Physician Contact (Who/When): Notified After hours (Nurse on Call) [telephone number redacted] Suzanne RN for Dr. Schemel.” P. Ex. 9 at 2; see P. Ex. 15 at 4 (family medicine clinic record that “Lori, LPN” called to “report a fall” and to “notify the doctor”); P. Ex. 15 at 3 (family medicine clinic record, authored by B. Tucker, R.N., documenting that she received “notification” of the fall from the facility and “document[ed] info for physician.”). Other than reporting that a facility nurse contacted the “[o]n call nurse,” there is no discussion in the evidentiary record of the time the physician was notified, nor is there any indication of the physician’s instructions, as required by the facility’s policy.23 CMS Ex. 27.

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         With respect to the second fall on February 6, the incident report is internally inconsistent; it states in one section that staff notified the on-call physician at 3:15 pm (CMS Ex. 20 at 5), yet states elsewhere that staff notified the on-call nurse at approximately 3:30 pm. CMS Ex. 20 at 1. Progress notes report that facility staff notified the nurse on call, and not the physician. CMS Ex. 21 at 20. Further, the family medicine clinic practice records do not document a telephone call any earlier than 5:45pm, at which time a physician gave orders to transfer Resident # 15 to the hospital. P. Ex. 15 at 1.

         In its reply brief, Petitioner acknowledges that the call service “is staffed by Registered Nurses” and that “a physician is consulted with every call.” P. Reply at 14. It thus appears that a nurse, and not a physician, would have received any call or message regarding Resident # 15’s falls. In examining whether this communication satisfied Petitioner’s own physician notification requirement in its policy, the DAB’s discussion of a facility’s obligation under the regulation at 42 C.F.R. § 483.10(b)(11)(i), which requires immediate physician consultation when a resident has a significant change in condition, is instructive. As the DAB has held:

         Consultation . . . requires a dialogue with and a responsive directive from the resident's physician as to what actions are needed; it is not enough to merely notify the physician of the resident’s change in condition. Nor is it enough to leave just a message for the physician. Also, the facility must provide the physician with all the information necessary to properly assess any changes to the resident's condition and what course of action is necessary. Failure to provide even one aspect of the change in a resident's condition can significantly impact whether the physician has been properly consulted.

         Magnolia Estates Skilled Care, DAB No. 2228 at 9 (2009). Although Petitioner correctly points out that CMS did not cite it for a deficiency involving the physician notification requirement of 42 C.F.R. § 483.10(b)(11)(i) (Tag F157),24 Petitioner’s “Accidents and Incidents – Investigating and Reporting” policy mandates that, in the event of an accident

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         or incident involving a resident, it document the time that a resident’s physician was notified and any instructions provided by the physician.

         Petitioner’s policy regarding changes in condition or status requires the nurse supervisor/charge nurse to “promptly notify” a resident’s attending physician or on-call physician when there has been an accident or incident involving a resident. CMS Ex. 29 at 1. Further, staff must notify the attending physician when there is a significant change in condition, which for purposes of this case, would certainly be a fractured hip requiring surgical repair, in combination with a head injury. CMS Ex. 29 at 1. After Petitioner contacted the on-call service after the successive falls on February 5 and 6, it is unclear what discussion, if any, occurred between Petitioner’s staff and Resident # 15’s physician. With respect to the February 5 fall, Petitioner contends that “the physician gave no new orders.” P. Br. at 11. However, Petitioner offered no documentation to support this assertion; there is no evidence in the record that, subsequent to its contact with the call service, Petitioner’s staff consulted with Resident # 15’s physician and the physician determined no orders were necessary. See CMS Ex. 27 (facility policy requiring Petitioner to document in the incident report “the time the physician responded and his or her instructions”).

         With regard to the February 6 fall, at the time staff found Resident # 15 on the floor she complained of pain at her right hip at a level of “10” and also had a large knot on her forehead, presumably from head trauma related to the fall. Resident # 15 thereafter reported “severe” and “increasing” pain at a level of “10” at several periodic checks. Despite communicating that she was suffering from the most severe pain possible, the facility did not act with urgency in reaching Resident # 15’s physician or transferring herto a hospital to provide her with medical treatment and relief of her severe pain. Had the facility taken Resident # 15’s reports of severe pain seriously, or had it conducted a physical examination that revealed the same right leg shortening that was evident to Central EMS when it transported her a mere .3 miles to the hospital (P.Ex. 7 at 2), it may have endeavored to reach her physician (or an on-call physician) in a timely manner to relieve the resident of her severe pain and to provide her the medical attention she needed.25 Therefore, Petitioner deprived Resident # 15 of necessary care and services.

         Petitioner’s records inconsistently report that it contacted the on-call nurse and on-call physician shortly after Resident # 15’s fall. CMS Ex. 20 at 1, 5; but see P. Ex. 15 (family medicine clinic records that do not evidence any discussions with an on-call nurse or physician prior to 5:45 pm). Petitioner’s contemporaneous records do not indicate that

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         Petitioner made contact with the physician by telephone immediately after the fall, nor do these records report any physician instructions or orders. Further, there is no indication that Petitioner communicated that Resident # 15 had a head injury or a severely painful injury to her hip any earlier than 5:45 pm.26 Resident # 15’s complaint of “10” level hip pain, in conjunction with the large knot on her head, amounted to a significant change in condition that required immediate physician notification. See CMS Ex. 29. Further, physical examination by Central EMS revealed obvious deformity, in the form of leg shortening. P. Ex. 7 at 2. Despite being aware of Resident # 15’s complaints of severe pain that did not abate, Petitioner continued to perform successively less thorough neurological checks while allowing her to continue in severe pain for several hours.

         Petitioner argues that its staff contacted the physician, asserting that a nurse notified the on-call physician of “the worsening of [Resident # 15’s] pain” at 5:34 pm.27 P. Reply at 10. While an LPN informed a surveyor that she called the answering service “[t]wo times, around 4:15 to 4:30; about an hour after that,” there is no documentary evidence of these calls in the progress notes or orders. CMS Ex. 33 at 6. Even if I accept as true that Petitioner’s staff called the on-call service at 5:34 pm, more than two hours after Resident # 15’s fall, this does not absolve Petitioner of its failure to notify the physician earlier. Moreover, assuming that Petitioner had left a message or messages with the on-call service, the evidence does not show that staff followed up when the calls were not returned. Rather, the staff allowed Resident # 15 to continue in severe pain for hours without benefit of treatment or pain management. In fact, Petitioner acknowledges that it did not even suspect a fracture. P. Ex. 29 at 7 (testimony that “no fracture would be suspected . . . .”).

         Petitioner also attempts to excuse its lack of adherence to policy by arguing that Resident # 15’s nonverbal expressions of pain were not consistent with her verbal expressions that her pain was at level “10.” P. Br. at 14-15. Petitioner essentially contends that it did not find Resident # 15’s reports of severe pain to be credible, arguing that when Resident # 15 stated her pain was at a level 10 at 5:15 pm, “for the first time

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         her nonverbal and verbal expressions of pain were consistent.” P. Br. at 15. I dismiss this unsupported post-hoc justification for Petitioner’s inaction.

         Further, and lost in the discussion of the severe pain Resident # 15 experienced due to her hip fracture, she also suffered a “ping pong ball sized knot” to her forehead when she fell. Petitioner recognized the possibility of head injury, as it conducted recurring, albeit incomplete, neurological assessments. CMS Ex. 20 at 7-21. Owing to Resident # 15’s head injury and severe hip pain resulting from a fall, along with her diagnosed ventricular tachycardia and hypertension (P. Ex. 1 at 2), Petitioner had an obligation, pursuant to its own policy, to consult with her physician. Petitioner’s failure to immediately notify Resident # 15’s physician of her change in condition undoubtedly deprived Resident # 15 from receiving timely medical care to alleviate her severe pain and treat her injuries, and Petitioner therefore failed to comply with section 483.25.

      3. 3.Petitioner was not in substantial compliance with 42 C.F.R. § 483.25, based on its failure to follow the INTERACT falls care path, which it adopted as its “standard of care” and policy, and it therefore failed to provide the necessary care and services to Resident # 15.

         Finally, Petitioner failed to provide the necessary care and services to Resident # 15, as evidenced by its failure to adhere to the INTERACT protocol following Resident # 15’s falls. Petitioner argues that “it utilized the INTERACT standard of care in assessing residents who experience a change in condition.” P. Br. at 7; see P. Ex. 29 (testimony that Petitioner “use[s] the INTERACT standard of care in assessing residents who experience a change in condition”); P. Ex. 30 (testimony that “[a]ccording to the INTERACT Care Path fall guidelines, [Resident # 15] was appropriate for management at the facility and a transfer to the hospital was not warranted.” ). Because Petitioner relied on INTERACT care path fall guidelines, it adopted this care path as its policy.

         CMS argues that the INTERACT protocol required Petitioner to measure Resident # 15’s oxygen saturation levels. CMS Reply at 2-3; P. Ex. 19. The INTERACT care path requires that staff take a resident’s vital signs, including oxygen saturation, after a fall. P. Ex. 19; see CMS Reply at 2. In response, Petitioner argues that it utilized the INTERACT falls care path to assess Resident # 15 after her falls. P. Reply at 11, 12. Petitioner does not dispute CMS’s allegation that it did not obtain Resident # 15’s oxygen saturation levels after either fall. P. Reply at 8, 12. Rather, Petitioner argues that because Resident # 15 did not exhibit shortness of breath, it was unnecessary to conduct pulse oximetry. P. Br. at 10, 12; P. Reply at 5, 9; P. Supp. Br. at 8, 10; P. Ex. 31 at 7, 9-10.

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         Petitioner relies on the testimony of its witness, Dr. Carroll Holsted. 28 P. Ex. 31. According to Dr. Holsted, Petitioner’s staff “appropriately followed the INTERACT guidelines on both February 5 and 6, 2016.” P. Ex. 31 at 12. In discussing Resident # 15’s fall on February 5, Dr. Holsted notes, among other things, that Resident # 15’s vital signs were within normal limits and that “[o]xygen Saturation and finger stick blood sugars were not indicated since the resident had no shortness of breath and was not a diabetic.” P. Ex. 31 at 7. In discussing Resident # 15’s fall on February6,2016, Dr. Holsted again states that “[o]xygen saturation and finger stick glucose assessments were not indicated since she was not experiencing shortness of breath and she was not a diabetic.” P. Ex. 31 at 9-10. He opined that based on the nurse’s initial assessment, “[Resident # 15] did not meet the criteria for immediate transfer to an acute care hospital or notification to a physician.” P. Ex. 31 at 10.

         Dr. Holsted’s knowledge of INTERACT appears to be largely based on medical journal articles, as well as the CMS website.29 P. Ex. 31 at 2, 4-5. Nonetheless, even assuming as true Dr. Holsted’s retrospective opinion that it was unnecessary for facility nurses to obtain oxygen saturation levels, as instructed by the INTERACT care path, Dr. Holsted reached this conclusion after reviewing numerous medical records, both prior to and subsequent to Resident # 15’s injury, along with reviewing medical journal articles. P. Ex. 31 at 2 (Dr. Holsted’s listing of the numerous medical records, sources, and authorities he relied upon in making his opinion). Dr. Holsted’s researched opinion seemingly misses the point of Petitioner’s claim that it uses INTERACT as a standard of care; the INTERACT care path, in this context, is utilized as a framework for staff to follow when presented with a resident who has been injured in a fall. By following the care path correctly, individual nurses who have differing levels of education and nursing experience need not rely on their own judgment to meet the facility’s “standard of care” when caring for such a resident. Resident # 15, following her falls, was not cared for by Dr. Holsted; rather, a licensed practical nurse who lacked the education and training of Dr. Holsted, and who did not have immediate access to the scholarly publications that Dr. Holsted reviewed in reaching his opinion, provided the care. Petitioner should expect that its employees will comply with all steps of the INTERACT protocol that it claims is its “standard of care,” unless the facility has specifically directed its employees to make certain exceptions to the protocol outlined in the care path. There is simply nothing in

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         the INTERACT falls care path, absent facility guidance, that instructs the facility’s employees to disregard the instruction to perform pulse oximetry if a resident does not have shortness of breath. P. Ex. 19.

         The INTERACT care path for falls requires that, following a resident fall, facility staff must assess the following vital signs: temperature, blood pressure, pulse, apical heartrate (if pulse is irregular), respirations, oxygen saturation, and finger stick glucose (if the resident is diabetic). P. Ex. 19. Although Petitioner, in hindsight, argues it was unnecessary to obtain Resident # 15’s oxygen saturation level because she did not have shortness of breath,30 Petitioner has offered no evidence that picking and choosing the vital signs that should be monitored is consistent with the INTERACT quality improvement program, absent direction to its staff to make such an exception to the care path. To the contrary, evidence submitted by Petitioner supports that the INTERACT tools include “critical data” and the “[e]arly identification and evaluation of changes in condition before they become severe enough to require hospital transfer.” P. Ex. 22 at 2, 4. By using INTERACT as “the standard of care in assessing residents who experience a change in condition,” Petitioner should expect that its staff will follow the care paths unless directed otherwise. Further, although Dr. Holsted may have the medical expertise to determine it is unnecessary to obtain certain vital signs before determining whether to notify a physician, Petitioner has not demonstrated that its individual employees are trained to make such determinations on a case-by-case basis.

         Finally, I point out that the computer-generated form Petitioner uses to conduct post-fall neurological assessments does not fully incorporate the INTERACT protocol; for instance, the form does not contain fields for staff to record oxygen saturation and blood glucose levels.31 See CMS Ex. 20 at 7-21. Therefore, employees who use this form when conducting post-fall vitals assessments are not oriented to conducting these assessments in a manner consistent with the INTERACT “standard of care.” Although Petitioner argues that the INTERACT protocol is its standard of care, it has not demonstrated that it required compliance with this standard of care. Petitioner therefore did not provide the necessary care and services as required by section 483.25.

      4. 4.Petitioner’s remaining arguments lack merit.

         Petitioner argues that the language in the statement of deficiencies under Tag F309 is “confusing and misleading” regarding Resident # 15 and the events of

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         February 5 and 6,2016, and is therefore prejudicial to Petitioner. P. Br. at 18; P. Supp. Br. at 17. Petitioner argues that if the purported inaccuracies stand as drafted in the statement of deficiencies, it would “remain a permanent record with respect to Petitioner’s survey history, which is prejudicial to CMS’ future determinations.” P. Supp. Br. at 19. The DAB has explained that “a state agency’s survey findings constitute recommendations to CMS.” Avon Nursing Home, DAB No. 2830 at 14 (2017) (emphasis in original), citing 42 C.F.R. §§ 488.11,488.12. The DAB further explained that “CMS makes its own determination of noncompliance, and decides what enforcement action to take, based on the survey’s findings.” Id. Simply stated, Petitioner cannot challenge the state agency’s recommendations that are contained in the statement of deficiencies.

         Petitioner also makes an unsupported and undeveloped argument that it challenges “the DAB’s apparent policy choice to impose the burden on Petitioner to demonstrate ‘substantial compliance’” because it contravenes the Administrative Procedure Act, 5 U.S.C. § 556(d).” P. Br. at 25. This argument is not persuasive; “[a]s the record here contains substantial evidence of [Petitioner’s] noncompliance, the agency’s procedural framework is immaterial to the outcome.” Greenbrier Nursing & Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., 686 F.3d 521, 529 (8th Cir. 2012). Petitioner also “challenges the DAB’s policy that permits CMS to impose CMPs without offering evidence that it considered the regulatory criteria set forth at 42 C.F.R. §§ 488.404 and 488.438(f) . . . .” P. Br. at 25-26. However, despite making this argument, Petitioner does not argue that the CMP is inappropriate based on application of the factors outlined in 42 C.F.R. §§ 488.404 and 488.438(f). Further, and with respect to these arguments, I am bound by the law and I cannot create a new policy that is inconsistent with the law. 1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009) (“An ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground.”); Russell L. Reitz, M.D., DAB No. 2748 at 8 (2016) (“[T]he ALJ and the [DAB] are bound by the Secretary’s regulations” and “Petitioner is free to make his . . . argument to a court, but we may not invalidate or refuse to apply a regulation.”).

      5. 5.The immediate jeopardy determination is not subject to review because the amount of the per-instance CMP is not affected by a determination of whether there is immediate jeopardy.

         CMS concluded that Petitioner’s noncompliance with 42 C.F.R. § 483.25 posed immediate jeopardy at the “J” scope and severity level. Because CMS imposed a per-instance CMP for this deficiency, I lack authority to review CMS’s immediate jeopardy determination.

         The regulations are clear that an ALJ may review CMS’s scope and severity findings (which includes a finding of immediate jeopardy) only if a successful challenge would affect: (1) the range of the CMP amounts that CMS could collect; or (2) a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide

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         training program. 42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii); NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014). Neither of these factors apply.

         Unlike per-day CMPs, under the regulations, there is only a single range for a per‑instance CMP, which at the time of the survey was $1,000 to $10,000, regardless of whether or not immediate jeopardy is present. 42 C.F.R. §§ 488.408; 488.438(a)(2). Consequently, because CMS only imposed a per-instance CMP against Petitioner, a successful challenge to the immediate jeopardy finding would not affect the range of CMP amounts that CMS could collect. NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014). Moreover, the record does not evidence that Petitioner has a nurse aide training program. For these reasons, the immediate jeopardy finding is not subject to appeal and I may not review it.

      6. 6.A per-instance CMP of $6,000 is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.25.

         If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, to include a per-instance CMP. I conclude that the CMP amount is reasonable.

         In determining whether the per-instance CMP amount imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3). These factors include: (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) the factors specified at 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. The factors at 42 C.F.R. § 488.404 include: (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

         CMS imposed a per-instance CMP of $6,000 for the noncompliance with 42 C.F.R. § 483.25. CMS claims that Petitioner has not challenged the reasonableness of the proposed CMP amount. Petitioner made no reference to the CMP in its request for hearing. In its briefs, Petitioner does not discuss the CMP other than to state that no basis exists for its imposition.

         CMS submitted Petitioner’s Certification and Survey Provider Enhanced Reports (CASPER) report, which includes survey findings for the period January 2013 through February 2016, and another document titled “AEM Nursing Home Enforcement History,” which shows Petitioner’s compliance history for the period October 2004 through

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         June 2016, both of which evidence prior noncompliance with 42 C.F.R § 483.25 (Tag F309).32

         Petitioner has not offered any evidence showing an inability to pay the per-instance CMP. Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it. Coquina Ctr., DAB No. 1860 (2002).

         The deficiency here is serious. Petitioner had in place written policies regarding resident accidents, neurological checks, and reporting of changes of condition to a resident’s physician. These policies evidence the standard of care that was to be followed by Petitioner in its care of its residents. Petitioner failed to provide the necessary care and services for Resident # 15, even allowing her to suffer in severe pain for more than three hours following her hip fracture. The per-instance CMP, which is in the middle of the per-instance CMP range, is reasonable for Petitioner’s noncompliance with Medicare requirements, owing to the facility’s indifference to Resident # 15’s needs and its history of noncompliance. See 42 C.F.R. §§ 488.408(d)(1)(iv), 488.438(a)(2).

IV.Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25. The imposition of a $6,000 per-instance CMP is a reasonable enforcement remedy.