Lutheran Home, DAB No. 3146 (2024)

REMAND OF ADMINISTRATIVE LAW JUDGE DECISION

Petitioner Lutheran Home, a Wisconsin skilled nursing facility (SNF) that participates in the Medicare program, appeals the decision of the Administrative Law Judge (ALJ) in Lutheran Home, DAB CR5922 (2021) (ALJ Decision).  The ALJ upheld, on summary judgment, a determination by the Centers for Medicare & Medicaid Services (CMS) to impose on Petitioner a per-instance civil money penalty (CMP) of $17,350 based on its determination that Petitioner failed to comply substantially with Medicare participation requirements in 42 C.F.R. § 483.25, captioned “Quality of care.”

This case arises from events on January 19, 2019.  That day, Resident 2 (R2) had, among other things, episodes of vomiting before R2 was transferred, in the early evening, to the hospital.  There, R2 was diagnosed with severe sepsis with septic shock, pneumonitis due to inhalation of food and vomit, and acute respiratory failure with hypoxia.

Petitioner asserts that the ALJ erred in entering summary judgment for CMS after concluding that Petitioner did not comply substantially with section 483.25 because Petitioner did not have a registered nurse assess R2 at 1:30 PM when R2 experienced an acute or significant change in condition, consistent with professional standards of practice.  Petitioner asserts, inter alia, that a genuine dispute of material fact exists as to whether, as CMS asserts, R2 experienced at 1:30 PM an acute or significant change in condition for which a formal assessment by a registered nurse was required.  Petitioner asks the Board to remand this case for a hearing at which Petitioner can cross-examine CMS’s witness, the surveyor who performed the survey of Petitioner’s facility, the findings from which were the basis for CMS’s enforcement action.

On de novo review, we conclude that the ALJ erred in deciding this case on summary judgment.  The record on which the ALJ decided in CMS’s favor, viewed in the light most favorable to Petitioner, the non-moving party, presents at least one genuine dispute of fact material as to whether Petitioner complied substantially with 42 C.F.R. § 483.25.  In addition, the ALJ appears to have assessed and weighed evidence, particularly testimonial evidence, inconsistent with the summary judgment standard.

Page 2

We vacate the ALJ Decision and remand this case to the ALJ for further proceedings, to include convening a hearing to permit the parties to cross-examine each other’s witness(es) (as both parties had requested earlier) before issuing a new decision on whether Petitioner did, or did not, substantially comply with section 483.25.  See 42 C.F.R. § 498.88(a); Illinois Knights Templar Home, DAB No. 2274, at 1 (2009) (vacating summary judgment decision and remanding for further proceedings); Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s Participation in the Medicare and Medicaid Programs (Guidelines), “Completion of the Review Process,” ¶ (c) (stating that the Board may remand an ALJ’s decision if “the decision is contrary to law or applicable regulations”).¹

Legal Background

Section 1819 of the Social Security Act (Act) and the regulations in 42 C.F.R. Part 483 govern the participation of SNFs in Medicare.²  To participate, a SNF must be in “substantial compliance” with the requirements in 42 C.F.R. Part 483, subpart B.  See 42 C.F.R. §§ 488.330(b), (f); 488.400; 483.1(b) (stating, in part, that “[t]he provisions of [Part 483] contain the requirements that an institution must meet in order to qualify to participate as a [SNF] in the Medicare program”).  A SNF is not in “substantial compliance” when it has a “deficiency” – that is, a failure to meet a participation requirement – that creates at least the potential for more than minimal harm to one or more residents.  Id. § 488.301 (defining “Substantial compliance” as “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”).  The term “noncompliance,” as used in the applicable regulations, is synonymous with a lack of substantial compliance.  Id. (defining “Noncompliance”).

Under agreements with the Secretary of Health and Human Services (through CMS), state survey agencies conduct periodic onsite surveys of SNFs to verify compliance with the participation requirements.  See 42 C.F.R. §§ 488.10(a); 488.11; 488.308; see also Act §§ 1819(g)(1)(A), 1864(a).  In addition to periodic surveys, state survey agencies conduct surveys to investigate complaints that SNFs are not complying with one or more of the participation requirements.  42 C.F.R. § 488.308(f).

The state survey agency reports to CMS any deficiencies it finds in a document called the “Statement of Deficiencies.”  Id. §§ 488.18; 488.325(f)(1).  The Statement of Deficiencies (Form CMS-2567) identifies deficiency citations using alpha-numeric “Tag”

Page 3

designations that correspond to the regulatory requirements and CMS’s guidance on the requirements.  See generally State Operations Manual (SOM), CMS Pub. 100-07, Ch. 7, Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities (including Appendices) (available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984).³  A Statement of Deficiencies also indicates the state survey agency’s assessment of the “seriousness” of a cited deficiency.  42 C.F.R. § 488.404(a).  Seriousness is a function of the scope of noncompliance (whether a deficiency is “isolated,” constitutes a “pattern,” or is “widespread”) and severity of noncompliance (whether a deficiency has created a “potential for” only “minimal harm” or a potential for “more than minimal harm,” resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  Id. § 488.404(b).  The most severe deficiency is that which puts one or more residents in “immediate jeopardy.”  See id. § 488.438(a) (authorizing the highest per-day CMPs for “immediate jeopardy” noncompliance); Woodland Oaks Healthcare Facility, DAB No. 2355, at 2 (2010) (citing authorities).  “Immediate jeopardy” means “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.

At issue here is 42 C.F.R. § 483.25, the prefatory language of which states as follows:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .

42 C.F.R. § 483.25.⁴  This “language sets out the overarching requirement and congressional mandate of the quality of care provision” in section 1819(b) of the Act.

Page 4

Sheridan Health Care Ctr., DAB No. 2178, at 16 (2008); see also Emery Cnty. Care & Rehab. Ctr., DAB No. 3006, at 8 n.5 (2020) (stating that section 483.25’s lead-in language “tracks the wording” of sections 1819(b)(1) and (2) of the Act).

Section 483.25 envisions an “outcome-oriented” approach on how to meet the quality-of-care standard.  See Spring Meadows Health Care Ctr., DAB No. 1966, at 18 (2005); Sheridan, DAB No. 2178, at 14 (stating that section 483.25 “emphasizes resident outcome as a measure of compliance”).  A SNF is presumed to have, or to be able to obtain by contract, the expertise necessary to determine resident needs and is then responsible for planning for, and providing the care and services responsive to, those needs.  See Life Care Ctr. of Bardstown, DAB No. 2479, at 22 (2012), aff’d, 535 F. App’x 468 (6th Cir. 2013); Spring Meadows, DAB No. 1966, at 16; Cedar Lake Nursing Home, DAB No. 2344, at 8-9 (2010).  A SNF must take all reasonable steps and practicable measures to meet applicable professional standards of quality, particularly since other regulations require the SNF to meet such standards by providing services or arranging to provide them.  See Sheridan, DAB No. 2178, at 15 (stating that section 483.25 “implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality”); Spring Meadows, DAB No. 1966, at 17 (stating that “professional standards of quality . . . define the minimum services that must be provided”), 19 (stating that “the outcome being looked at is the quality of care being provided, not just the health outcome for the individual resident”).  A SNF also would need to furnish the care and services in the resident’s care plan, implement doctors’ orders, monitor and document the resident’s condition, and follow the SNF’s resident care policies.  See Rehab. Ctr. at Hollywood Hills, DAB No. 3052, at 21 (2021); Heritage House of Marshall Health and Rehab., DAB No. 3035, at 10 (2021); Embassy Health Care Ctr., DAB No. 2327, at 6 (2010); see also SOM, App. PP (guidance for Tag F684 for noncompliance with section 483.25) (Rev. 173, Effective Nov. 28, 2017), PDF page 282 (explaining that the “needed care and services” a SNF must “identify and provide” are “resident centered, in accordance with the resident’s preferences, goals for care and professional standards of practice that will meet each resident’s physical, mental, and psychosocial needs”).

CMS may impose enforcement “remedies” on a SNF that is not in substantial compliance with one or more participation requirements.  See Act § 1819(h); 42 C.F.R. §§ 488.400; 488.402(b), (c); 488.406.  Remedies may include a CMP for each “instance of noncompliance.”  42 C.F.R. §§ 488.408(d)(1)(iv), (e)(1)(iv); 488.430(a).  When CMS imposed the per-instance CMP here, the authorized range for a per-instance CMP was $2,140 to $21,393.  See id. § 488.438(a)(2); 45 C.F.R. § 102.3 (as amended effective Oct. 11, 2018); 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018).

A SNF may challenge a determination of noncompliance that has resulted in the imposition of a remedy by requesting an ALJ hearing and appealing any unfavorable ALJ decision to the Board.  See 42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(b)-(c).  The

Page 5

scope of review may include whether the amount of the CMP is reasonable.  See id. § 488.438(e)(3), (f); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629, at 2-3 (1997).  However, a SNF may not contest CMS’s finding about the “level of noncompliance” (e.g., a finding of immediate jeopardy) except in limited circumstances, such as when a successful challenge would affect the range of CMP amounts that CMS may impose.  42 C.F.R. § 498.3(b)(14).

Case Background

A.        American Medical Directors Association Guidelines

Petitioner maintains that the American Medical Directors Association’s Acute Change of Condition in the Long-Term Care Setting (AMDA Guidelines, of record as Petitioner’s exhibit 9),⁵ provides the professional standards relevant to determining whether Petitioner complied substantially with section 483.25, and that Petitioner complied with the AMDA Guidelines.  See ALJ Decision at 8; P.’s Combined Pre-Hr’g Br., Mot. to Dismiss Summ. J., and Req. Cross Examination of CMS’ Witness Barbara Soldovieri (P. Pre-Hearing Brief) at 16-17 (also asserting that Petitioner’s nursing professionals complied with Wisconsin state nursing standards); P.’s Br. Appealing ALJ’s Decision to Grant CMS’ Mot. for Summ. J. and Req. to Appear before the Board (P. Br. to Board) at 5 (also stating that state nursing standards follow AMDA Guidelines), 13.  The Board has recognized SNF implementation of resident policies modeled on AMDA’s clinical guidelines.  See Bardstown, DAB No. 2479, at 10-11 (discussing resident policy based on AMDA’s guidelines in assessing alleged noncompliance with Part 483’s “notification of changes” provisions).

The AMDA Guidelines discuss in detail how to:  identify risks for and causes of acute changes in condition; describe and document signs and symptoms; establish a patient’s baseline levels; identify, monitor, and manage improvement or deterioration; and set and adjust interventions and goals.  See P. Ex. 9.  Notably, the AMDA Guidelines define “acute change of condition” as “a sudden, clinically important deviation from a patient’s baseline in physical, cognitive, behavioral, or functional domains.”  Id. at 7; see also ALJ Decision at 10 (quoting AMDA Guidelines).  A “[c]linically important” deviation is one “that, without intervention, may result in complications or death.”  P. Ex. 9, at 7; see also ALJ Decision at 10 (quoting AMDA Guidelines).

Page 6

The AMDA Guidelines also discuss the following “[c]ategories of [s]ymptoms” relevant to “defin[ing]” an acute change in condition.  P. Ex. 9, at 18.

Respiration:  Respiration at a rate of 16-25 breaths per minute, “with approximate 2:1 inspiration/expiration ratio,” is within a normal range for the elderly.  However, caregivers should observe the patient for, among other factors, marked changes from the usual respiration pattern or rhythm, irregular breathing, and audible noises related to breathing.  Id.

Temperature:  Normal oral temperature ranges between 98.2º F and 99.9º F but could vary by up to 0.9º F daily; however, “[a] sudden or rapid change from normal temperature may suggest an” acute change in condition.  Id.  For instance, one temperature reading above 100º F, two readings above 99º F, or an increase of 2º F above the upper end of the patient’s normal range could indicate an acute change in condition.  Id.  After obtaining an isolated temperature reading that is outside the patient’s normal range, caregivers should repeat the temperature readings approximately every 4 hours for up to 24 hours and seek other signs and symptoms to determine whether the patient is experiencing an acute change in condition.  Id.  Factors that could affect temperature, such as the use of medications, should be considered.  Id.

Blood Pressure: Normal blood pressure range is approximately systolic 100-140 mmHg, diastolic 60-90 mmHg.  Id.  “Isolated” elevations in blood pressure “generally are not significant,” but “[s]ustained elevations in systolic pressure should trigger further assessment.”  Id.  However, “[a]ny significant decrease in” blood pressure (such as “systolic BP ˂ 100 mmHg if baseline is 110 mmHg, decline in BP accompanied by other symptoms such as dizziness, decline ≥ 15 mm in systolic BP, combination of pulse > 100 beats per minute [BPM] and/or systolic BP ˂ 100 mmHg”) could signal an acute change in condition.  Id. (alteration in original).  The AMDA Guidelines also caution that a change in blood pressure “is more often a symptom than a cause of an” acute change in condition and “alone should not trigger a call to the practitioner without additional signs or symptoms.”  Id.  “Blood pressure may fluctuate without requiring immediate attention.”  Id. at 17.

Pulse:  Normal pulse ranges from approximately 60-100 beats per minute (or BPM) but can vary by about 10%.  Id. at 18.  Certain clinical presentations, including sustained change from normal range, change in usual pulse rhythm or regularity, pulse “> 120 BPM or ˂ 50 BPM,” or pulse “> 100 BPM combined with other symptoms,” could indicate an acute change in condition that warrants further assessment.  Id.

Page 7

In addition, the AMDA Guidelines provide that certain changes in condition, vital signs, and laboratory values call for immediate reporting to a practitioner, whereas other developments may be reported on the next office day.  See id. at 22-23 (Table 13, “Examples of Condition Changes to Report to a Practitioner,” and Table 14, “Framework for Reporting Changes in Vital Signs or Laboratory Values to a Practitioner”).  For instance, an “[a]cute onset of multiple stools with change in vital signs” should be reported immediately, but persistent loose stools “for > 48 hours while diarrhea is being treated symptomatically” may be reported the next office day.  Id. at 22.⁶

B.        Events of January 19, 2019 ⁷

On January 19, 2019, R2 had a medical history that included functional quadriplegia, vascular dementia with behavioral disturbance, dysphagia following nontraumatic subarachnoid hemorrhage, and hemiplegia and hemiparesis following cerebral infarction affecting the right dominant side.  CMS Ex. 9, at 4; P. Ex. 4, at 1.  R2 also was “at risk for choking, aspiration and/or aspiration pneumonia” due to a “chewing or swallowing impairment.”  P. Ex. 6, at 1.

At approximately 12:30 PM, R2 vomited in the dining room.  P. Ex. 1, at 2 (¶ 6).  Around that time, a Licensed Practical Nurse (LPN) (identified by the parties as LPN-D and whose initials are T.B., see, e.g., CMS Ex. 8, at 3) took R2’s vital signs, which were determined to have been within normal limits,⁸ and had R2 returned to her room.  P. Ex. 1, at 2 (¶ 6); CMS Ex. 1, at 2.

At approximately 1:30 PM, while in her room, R2 vomited again and had a loose bowel 

Page 8

movement.  P. Ex. 1, at 2 (¶ 8); CMS Ex. 1, at 2.⁹

Around the same time, LPN-D noted “[c]ongestion” and documented oxygen saturation (O2) level of 82%, blood pressure of 144/62, respiration at 20, pulse at 68, and temperature 100.6º F.  P. Ex. 1, at 2 (¶ 8); P. Ex. 8, at 1-2 (¶ 5); CMS Ex. 1, at 2.  LPN-D reported R2’s vitals to two individuals – a Nursing Supervisor and D. Wilhelm, RN, Petitioner’s manager of staff education and employee health, who was the manager on duty on January 19.  CMS Ex. 1, at 6; P. Ex. 8, at 1-2 (¶¶ 1, 4, 5); P. Ex. 1, at 2 (¶ 9).  RN Wilhelm acknowledged LPN-D’s report, directed LPN-D to obtain a pulse oximetry reading, which was reported as 82%, and agreed with LPN-D to start oxygen at 2 liters per minute and administer Tylenol for the low-grade fever.  P. Ex. 8, at 1‑2 (¶ 5); CMS Ex. 8, at 3.¹⁰  Further, as a precaution against spreading the norovirus the facility had determined was present in the building, the facility initiated an isolation protocol for R2 and put R2’s name on the 24-hour board for continuity of care and ongoing monitoring and assessment.  P. Ex. 1, at 2 (¶ 9); CMS Ex. 8, at 3.

Also, at approximately 1:31 PM, LPN-D called Optum Care with which Petitioner had contracted to provide clinical support and physician referral services for Petitioner’s residents.  P. Ex. 1, at 2 (¶ 7); CMS Ex. 6, at 1.  LPN-D reported to Optum Care that R2 vomited twice after lunch; that a “stomach virus” was present on another floor in the building (with another resident on the same floor who had similar symptoms starting earlier in the week); and that R2’s vital signs were blood pressure at 170/68, pulse at 72, respiration at 18, temperature at 98.2º F, and O2 level at 96%.  CMS Ex. 6, at 1; P. Ex. 1, at 2 (¶ 7).  Optum Care told LPN-D that an on-call nurse practitioner would return the call.  CMS Ex. 6, at 1; CMS Ex. 1, at 5; CMS Ex. 8, at 3; P. Ex. 1, at 2 (¶ 7).

At approximately 3:15 PM, a registered nurse (RN) (initials N.H.; referred to by the parties as RN-R) who regularly cared for R2 went to R2’s room, saw the isolation cart outside the room, visually assessed R2 without entering the room, and observed R2 resting comfortably and in no apparent respiratory distress.  P. Ex. 1, at 2-3 (¶ 11); P. Ex. 3, at 2-3 (¶¶ 11-12); CMS Ex. 1, at 14; CMS Ex. 8, at 3.  R2’s daughter and health care agent indicated her mother appeared “fine” at that time and, because R2 was isolated, RN-R decided to first check on other residents who had been identified for high-priority monitoring before returning to check on R2.  CMS Ex. 1, at 14; P. Ex. 3, at 3 (¶ 13).

Page 9

At approximately 3:50 PM to 4:10 PM, the facility noted that R2 vomited again and had another loose bowel movement.  P. Ex. 1, at 3 (¶ 12).  Shortly after 4:00 PM, a licensed practice nurse (initials V.I.; referred to as LPN-H) noted R2 was congested, and that R2’s vitals included O2 level at 82%, respiration at 50, and temperature at 98.5º F.  CMS Ex. 1, at 11; CMS Ex. 8, at 2-3; P. Ex. 1, at 3 (¶ 12).  The facility administered oxygen (by mask) at an increased rate of 4.5 liters per minute, with O2 levels fluctuating between 84% and 89%.  CMS Ex. 1, at 11; CMS Ex. 8, at 2; P. Ex. 1, at 3 (¶ 12).  R2’s daughter asked Petitioner to send her mother to the hospital.  CMS Ex. 8, at 2; P. Ex. 1, at 3 (¶ 12).

Around the same time, RN-R, who was called to assess R2, recorded R2’s O2 level as “remain[ing] at 82% on 4.5 L O2 via oxy[gen] mask with respirations of 50.”  CMS Ex. 8, at 2; see P. Ex. 1, at 3 (¶ 13); P. Ex. 3, at 3 (¶¶ 14-15).  RN-R also reported hearing rhonchi “in all lung fields.”  CMS Ex. 8, at 2.  Based on the indications presented around this time, Petitioner determined that R2 was experiencing an acute change in condition.  P. Ex. 3, at 3 (¶¶ 14, 15).  RN-R called Optum Care and was ordered to transfer R2 to a hospital.  CMS Ex. 8, at 2; P. Ex. 3, at 3 (¶ 17).

At 4:51 PM, Petitioner called the ambulance company.  CMS Ex. 13.  The first ambulance arrived at 5:09 PM; the second, “assist” ambulance, which was called because ambulance personnel could not establish an intravenous line, arrived at 5:28 PM.  Id.; P. Ex. 1, at 3 (¶¶ 14-15); P. Ex. 3, at 3 (¶¶ 18-19); CMS Ex. 8, at 2.  At 5:50 PM, R2 arrived at the hospital and was later admitted to the Intensive Care Unit with diagnoses of severe sepsis with septic shock, pneumonitis due to inhalation of food and vomit, and acute respiratory failure with hypoxia.  CMS Ex. 1, at 8; CMS Ex. 12, at 22.  R2 remained on a ventilator for three days and then received hospice care until her passing on January 26, 2019.  CMS Ex. 1, at 8.

C.        Survey Findings and CMS’s Imposition of Remedies

The Wisconsin Department of Health Services (state agency) conducted a complaint survey of Petitioner from February 26 to February 28, 2019.  CMS Ex. 1, at 1.  The state agency found that Petitioner did not comply substantially with 42 C.F.R. § 483.25 and 42 C.F.R. § 483.25(d) and identified the following two Tags:

• Tag F684, for failure to substantially comply with 42 C.F.R. § 483.25, at scope/severity level J (isolated; posed immediate jeopardy to health and safety), arising from the above-described events concerning R2; and
• Tag F689, for failure to provide Resident 1 with adequate supervision and assistance devices to prevent accidents as required under 42 C.F.R. § 483.25(d)(1) and (d)(2), at scope/severity level D (isolated; no actual harm with potential for more than minimal harm that is not immediate jeopardy).

Page 10

Id. at 1, 16.¹¹  The state agency completed a partial extended survey on March 6, 2019, and a revisit survey on April 18, 2019.  Id. at 1; CMS Ex. 5, at 1‑2.

Based on the survey findings, CMS determined that Petitioner did not substantially comply with 42 C.F.R. § 483.25, and 483.25(d)(1) and (d)(2).  CMS Ex. 5 (May 15, 2019 CMS notice), at 1.  CMS imposed a per-instance CMP of $17,350 for the immediate-jeopardy deficiency, cited as Tag F684.¹²  Id. at 2.  CMS’s May 15, 2019 notice does not indicate that CMS imposed any specific remedy for the deficiency cited as Tag F689.  CMS also informed Petitioner that it was prohibited from offering a Nurse Aide Training and/or Competency Evaluation Program for two years from March 6, 2019 because it was subject to a partial extended survey.  Id. at 4.  (CMS initially proposed additional remedies of discretionary denial of payment for new admissions and mandatory termination of Petitioner’s provider agreement but rescinded them because Petitioner returned to substantial compliance before the remedies were to take effect.  CMS Ex. 5, at 2; ALJ Decision at 1 n.1.)

D.        ALJ Proceedings and Decision

1. ALJ Proceedings

Petitioner requested a hearing before an ALJ to contest only the deficiency alleging noncompliance with 42 C.F.R. § 483.25 (Tag F684) and the corresponding per-instance CMP of $17,350.¹³  Request for hearing at 1.

On July 11, 2019, an ALJ issued a pre-hearing order, which, inter alia, set out a schedule for filing pre-hearing exchanges and informed the parties that each may move for summary judgment in its favor.  Acknowledgment & Pre-Hearing Order ¶¶ 5, 6.  That

Page 11

order also notified the parties that they may submit as a proposed exhibit the written direct testimony of a proposed witness.  Id. ¶ 9.  The order also informed the parties that each may cross-examine the opposing party’s witness for whom written direct testimony was offered.  Id. ¶ 10.  The order also stated, “A hearing to cross-examine witnesses will be necessary only if a party submits admissible, written direct testimony as part of its pre‑hearing exchange, and the opposing party requests cross-examination.”  Id. ¶ 11.

Petitioner asked the ALJ to issue, in accordance with 42 C.F.R. § 498.58, a subpoena duces tecum ordering the ambulance company and the hospital to which R2 was transferred on January 19, 2019, to produce records concerning R2.  CMS did not object to the request.  By order dated September 25, 2019, the ALJ granted Petitioner’s subpoena request as to the hospital but denied it as to the ambulance company because Petitioner did not specify the date ranges for the records sought.  Petitioner then submitted a revised subpoena request for the ambulance company, which the ALJ granted by order dated September 30, 2019.  See generally Civil Remedies Division (CRD) Dkt. C-19-922, DAB E-File entries 5a (CRD Procedures ¶ 12c), 12-17.¹⁴

CMS filed a pre-hearing brief in which it moved for summary judgment in its favor (CMS MSJ), exhibit and witness lists, and 14 proposed exhibits.  One exhibit was the declaration of B. Soldovieri, RN, who performed the complaint survey in February 2019 but did not participate in the surveys in March and April 2019.  ALJ Decision at 2; CMS Ex. 14 (Soldovieri Decl.), at 1-2 (¶¶ 5, 7, 8).  CMS argued, in chief, that Petitioner did not provide R2 with treatment and care in accordance with professional standards of practice consistent with 42 C.F.R. § 483.25 because the undisputed facts of the events on January 19, 2019, support a finding that a registered nurse did not assess R2 at 1:30 PM, when R2 experienced a significant change in condition.  CMS MSJ at 2, 8-11.

Petitioner filed its pre‑hearing brief opposing summary judgment for CMS, together with exhibit and witness lists, and 10 proposed exhibits.  ALJ Decision at 2.  Petitioner’s exhibits included the declarations of four individuals:  K. Cavers, Petitioner’s Administrator and Chief Operating Officer (COO); A. Cain, RN, Petitioner’s Director of Nursing; K. Jonas, a family nurse practitioner with Optum Care; and RN Wilhelm.  P. Exs. 1, 3, 7, 8.  Petitioner argued that numerous disputes of material fact exist.  P. Pre‑Hearing Brief at 1-2.  Among those disputed facts, Petitioner asserted, were the “timing of R2’s change of condition” and “when a formal RN assessment was required to be completed.”  Id. at 2.  According to Petitioner, R2 had an acute change in condition at approximately 3:50 PM to 4:10 PM on January 19, to which Petitioner responded with a

Page 12

formal assessment by a registered nurse consistent with applicable authorities and professional standards of practice.  Id. at 2, 4, 5, 16-18, 19-20.  Petitioner asked the ALJ to convene a hearing to cross-examine Soldovieri, whose declaration, Petitioner argued, included “discrepancies.”  Id. at 3, 20.

On November 22, 2019, CMS filed a request to cross-examine Petitioner’s witnesses.

In the absence of any objection to the proposed exhibits, the ALJ admitted all of them.  ALJ Decision at 2-3.  We understand the ALJ to have found no reason to exclude any of the declarations.  We see no indication that either party withdrew its earlier request to cross-examine the opposing party’s witness(es).  Nor did the parties indicate they would accept a decision based on the written submissions alone.  The ALJ did not convene a hearing and proceeded to resolve this case on summary judgment.

2. ALJ’s Analysis – 42 C.F.R. § 483.25 (Tag F684)

We confine our discussion in this subsection to a summary of the ALJ’s key findings, analysis, and conclusions.

The ALJ first noted that, in general, the parties did not dispute “[t]he relevant facts” as derived “primarily from the facility’s own records.”  ALJ Decision at 4; see id. 4-7 (setting out a timeline of events on January 19, 2019).  The ALJ noted a few “discrepancies” concerning the facts but indicated the ALJ would view them favorably for Petitioner whenever possible and appropriate.  For instance, the ALJ noted certain “discrepancies” in the exact timing of certain events but relied on the times reported by Petitioner.  See id. at 4 n.4; see also id. 5-6 nn.6-11.

The ALJ considered the nature of the dispute and the regulatory standard Petitioner must have met.  The ALJ noted that the parties disagreed on “when,” not on whether, R2 had an acute or significant change in condition on January 19.¹⁵  Id. at 8.  The ALJ also noted that neither party disputed that, as relevant here, to meet section 483.25’s quality-of-care standard, a SNF must provide an assessment by a registered nurse when a resident has an

Page 13

acute or significant change in condition.¹⁶  Id.

Also, noting that section 483.25 does not, by its terms, use “significant change of condition” or “acute change of condition” as a standard for assessing the quality of care provided, the ALJ looked to the AMDA Guidelines Petitioner stated it followed, as well as other regulations and the SOM, for guidance.  Id. at 8-10.  The ALJ considered:

• 42 C.F.R. § 483.20(b)(2)(ii), which requires a “comprehensive assessment” when a resident has a significant change in physical or mental condition (id. at 9);
• SOM, Appendix PP guidance defining “significant change” consistent with section 483.20(b)(2)(ii) (id. at 10); and
• 42 C.F.R. § 483.10(g)(14)(i)(B), which requires a facility to immediately consult the resident’s physician when there has been a “significant change” in the resident’s physical, mental, or psychosocial status (id.).

Applying the standards to the “undisputed facts,” the ALJ noted that, based on records from December 6, 2018 through January 17, 2019, the vital signs defining R2’s “baseline functioning” included temperature ranging from 97.3º F to 98.2º F, respiration rates ranging from 15 to 18 per minute, O2 levels ranging from 94% to 96%, and blood pressure readings ranging from 110/63 to 130/64.  Id. at 10 (citing CMS Ex. 9, at 3, 8, 13, 28, 33); see also CMS Ex. 9, at 18, 23 (additional notation of certain vital signs on Dec. 27, 2018 and Jan. 3, 2019).  R2’s vital signs were reportedly normal at approximately 12:30 PM on January 19, 2019.  ALJ Decision at 10 (citing P. Ex. 1, at 2).

The ALJ determined that, less than an hour after the “normal” signs noted at approximately 12:30 PM on January 19, R2 had an acute or significant change in condition when the O2 level dropped to 82% and the temperature rose to 100.6º F, and R2 was observed to be congested.  Id. at 10 n.16, 10-11 (citing CMS Ex. 8, at 3).  The ALJ also noted that R2 vomited at least twice and had at least one loose bowel movement, after having had a large, regular one in the morning.  Id. at 11 (citing CMS Ex. 8, at 3; CMS Ex. 6).  These developments, the ALJ stated, indicated an acute or significant change in condition at 1:30 PM, for which “medical interventions” in the form of oxygen and Tylenol were provided.  Id.  Nevertheless, the ALJ concluded that Petitioner “did not provide [R2] with an accurate and comprehensive assessment by an RN at 1:30 PM” and thus did not comply substantially with section 483.25.  Id. at 16-17.

Page 14

The ALJ further found that Petitioner did not comply substantially with section 483.25 by (1) not following up with Optum Care when Optum Care did not return the facility’s call; and (2) not updating Optum Care on the abnormal vital signs obtained at 1:30 PM, shortly after initial normal vital signs were reported.¹⁷  Id. at 15-16.  These failures, the ALJ stated, were “not consistent with Optum’s procedural instructions or with professional standards of practice.”  Id. at 16; see also CMS Ex. 7, at 1 (Optum Care’s procedures for on-call hours 5PM to 8AM Monday through Friday, and “24/7” on weekends and holidays; stating that if the caller does not receive a return call within 15 minutes, the caller should call again).

The ALJ rejected various arguments to the effect that the developments leading up to 1:30 PM did not represent an acute or significant change in condition at 1:30 PM, and that R2 first exhibited signs of such a change around 3:50 to 4:10 PM, at which point Petitioner had a registered nurse assess R2.  See ALJ Decision at 11-12.  The ALJ noted that Petitioner, “at one point,” asserted that the AMDA Guidelines “‘do not stipulate a set timeframe for an RN assessment’” and that, unless a resident’s condition is deteriorating rapidly or vital signs are “markedly” abnormal or unstable, there is ample time to conduct a more detailed assessment before initiating treatment.  Id. at 8-9 n.13 (emphasis omitted) (quoting P. Pre-Hearing Brief at 16 (citing P. Ex. 9)).  The ALJ noted that “there is no emphasis on ‘markedly’ in the AMDA guidelines” and, in any case, “the relevance of this citation is unclear in this case since an example in the guidelines . . . indicates that ‘if a patient has a fever or a change in level of consciousness, nurses generally have 30 minutes or more to carry out a careful evaluation before deciding whether an emergency transfer is necessary.’”  ALJ Decision at 8-9 n.13 (quoting P. Ex. 9, at 17).  However, the ALJ also found “no indication in this case” that Petitioner had “insufficient time to conduct an accurate and comprehensive assessment” of R2.  Id.

The dispute about when R2 had an acute or significant change in condition aside, Petitioner also asserted that its professionals provided a compliant assessment before 3:50 PM.  For one thing, Petitioner argued that RN Wilhelm’s consultation with, and instructions to, LPN-D constituted a compliant assessment at 1:30 PM, but the ALJ rejected the argument, reasoning that Wilhelm did not provide a “complete assessment” because Wilhelm “did not make her own observations, did not personally examine [R2], and, in fact, did not physically observe [R2].”  Id. at 14.  Petitioner also asserted, unsuccessfully, that RN-R conducted a visual assessment, compliant with state nursing standards, of R2 around 3:15 PM.  See id. at 12-14; id. at 13 n.18.  In rejecting this argument, the ALJ stated:

Page 15

There is no indication that the 3:15 PM RN assessment included a temperature reading, O2 level measurement, blood pressure check, or any other measure of vital signs.  “Eyeballing” the resident is not a substitute for the thorough assessment required by the professional standards of care.

Id. at 13.  Notably, the ALJ determined that the 3:15 PM “assessment” did not comport with the AMDA Guidelines and SOM guidelines.  Id. at 12-13.

The ALJ concluded that because Petitioner “did not provide [R2] with an accurate and comprehensive assessment by an RN at 1:30 PM, when [R2] first displayed findings documenting a significant change of condition, and did not follow up on a phone call to Optum when that occurred,” Petitioner “was not in substantial compliance with 42 C.F.R. § 483.25.”  Id. at 16-17.  The ALJ granted CMS’s motion for summary judgment.  See id. at 1-2, 4, 18.

3. ALJ’s Discussion of Immediate Jeopardy Determination and Remedies

The ALJ determined that the ALJ had no authority to review CMS’s determination on the scope and severity of the deficiency (immediate jeopardy) under the circumstances presented.  Id. at 3.  The ALJ stated, as relevant here, that a facility may only challenge, and the ALJ may only review, CMS’s determination on the scope and severity of a deficiency if (1) a successful change would affect the range of CMP assessed; or (2) if CMS found substandard quality of care that results in the loss of approval of a facility’s nurse aide training program.  Id. (citing 42 C.F.R. § 498.3(b)(14), (d)(10); Evergreen Commons, DAB No. 2175 (2008); Aase Haugen Homes, Inc., DAB No. 2013 (2006)).

The ALJ applied the factors in 42 C.F.R. § 488.438(f) and 42 C.F.R. § 488.404 (to which section 488.438(f) refers) and concluded that the $17,350 CMP was reasonable.  Id. at 17-18.  The ALJ noted that the CMP “is in the mid-to-high end of the penalty range for per instance penalties ($2,140-$21,393),” which, “[g]iven the tragic outcome” here, “is not unreasonable.”  Id. at 17 (citing 42 C.F.R. §§ 488.408(d)(1)(iv), 488.438(a)(2); 45 C.F.R. § 102.3 (2018); 83 Fed. Reg. at 51,380)).  The ALJ considered Petitioner’s history of below-immediate-jeopardy noncompliance that included noncompliance with quality-of-care standards and “a pattern of noncompliance in some areas.”  Id. (citing CMS Ex. 4; 42 C.F.R. § 488.404(b)); see 42 C.F.R. § 488.438(f)(1).

Petitioner did not claim that it was unable to pay $17,350.  ALJ Decision at 17; see 42 C.F.R. § 488.438(f)(2).  However, Petitioner argued that it substantially complied with section 483.25 (and thus no penalty should have been imposed) and asked for a recission of Tag F684, or alternatively a reduction of its scope and severity level to “D” with a corresponding reduction of the penalty amount.  ALJ Decision at 17.  In rejecting that argument and denying the requested relief, the ALJ determined that Petitioner’s failure to comply substantially with section 483.25 was “very serious” because it had “devastating

Page 16

results, for which [Petitioner] is culpable.”  Id. at 17-18; see 42 C.F.R. § 488.438(f)(4).

Standard of Review

Summary judgment is appropriate when there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.  Pearsall Nursing & Rehab. Ctr. - North, DAB No. 2692, at 5 (2016).  The “substantive law will identify which facts are material” and “[o]nly disputes over facts that might affect the outcome of the [case] under the governing law will properly preclude the entry of summary judgment.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); see also Livingston Care Ctr., DAB No. 1871, at 5 (2003) (stating that “[t]o defeat an adequately supported summary judgment motion, the non-moving party . . . must furnish evidence of a dispute concerning . . . a fact that, if proven, would affect the outcome of the case under governing law”), aff’d, 388 F.3d 168 (6th Cir. 2004).

The Board reviews whether summary judgment is appropriate de novo.  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703, at 5 (2016).  In evaluating a party’s motion for summary judgment, we view the record in the light most favorable to the non‑moving party (Petitioner) and give that party the benefit of all reasonable inferences.  Pearsall, DAB No. 2692, at 5; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); United States v. Diebold, Inc., 369 U.S. 654, 655 (1962).  However, we are not required to draw unreasonable inferences or accept the non-moving party’s legal conclusions.  Brightview Care Ctr., DAB No. 2132, at 10 (2007).  Inferences based on speculation are not reasonable.  Dumas Nursing & Rehab., L.P., DAB No. 2347, at 18 (2010).  The adjudicator must not “make credibility determinations, weigh the evidence, or decide which inferences to draw from the facts,” but instead, should “construe the record in the light most favorable to the nonmovant and avoid the temptation to decide which party’s version of the facts is more likely true.”  White Lake Family Med., P.C., DAB No. 1951, at 13 (2004) (original alterations omitted) (quoting Payne v. Pauley, 337 F.3d 767, 770 (7th Cir. 2003)); see also Anderson, 477 U.S. at 249.

The Board’s standard of review on a disputed conclusion of law is whether the ALJ’s decision is erroneous.  Guidelines, “Completion of the Review Process,” ¶ (c).

Analysis

Petitioner challenges only that part of the ALJ Decision which upheld CMS’s determination that Petitioner did not substantially comply with 42 C.F.R. § 483.25 and the imposition of the corresponding per-instance CMP.  See P. Br. to Board at 1-2.  We understand Petitioner to be asserting that there is no basis for the imposition of any CMP because Petitioner did not violate section 483.25.  Petitioner does not otherwise challenge the amount of the CMP (for instance, by arguing that the ALJ upheld an unreasonably high CMP by erroneously applying the statutory factors in 42 C.F.R. § 488.438(f)).

Page 17

Petitioner asks the Board to remand this case to the ALJ for a hearing during which Petitioner may cross-examine Soldovieri.  See id. at 2; P.’s Reply to CMS’ Resp. to P.’s Req. for Review by the Board (P. Reply Brief) at 2, 11-12.¹⁸

Petitioner continues to assert that there exist material factual disputes.  Petitioner asserts, inter alia, that R2 did not experience an acute change in condition at 1:30 PM on January 19, 2019.  See P. Br. to Board at 9, 12.  However, Petitioner also asserts that the parties do not see eye to eye on what constitutes a “significant” change for purposes of determining when a resident needs a formal assessment by a registered nurse.  Id. at 9-10; P. Reply Brief at 5 (stating that “the legal standard for what constitutes a significant change of condition is in dispute”).  According to Petitioner, since “the standard” CMS says Petitioner must have met “is not defined in the regulations,” “the precise moment at which a formal RN assessment is required is left to the professional discretion of the provider following recognized standards.”  P. Br. to Board at 10 (Petitioner’s emphases removed).  Petitioner asserts that the professional standards on which it relied contemplates “a more significant change in a resident’s symptoms,” such as “rapid deterioration and/or markedly abnormal vitals.”  Id. at 11.  In sum, Petitioner asserts that the standard it appropriately followed calls for a higher “threshold for the point at which” a registered nurse assessment is required.  Id. at 11-12.

CMS urges the Board to affirm the ALJ Decision because the ALJ correctly granted summary judgment for CMS.  According to CMS, the undisputed facts show that R2 “experienced a change in condition at 1:30 PM on January 19, 2019, at which point professional standards required an assessment by a registered nurse, which [Petitioner] failed to provide.”  CMS’ Resp. to P.’s Req. for Review (CMS Response Br.) at 1.

The Board has stated that “[t]he combination of the fact-based nature of section 483.25[] citations and summary judgment review standards make summary judgment ‘particularly unsuited in most cases for resolving issues arising under section 483.25.’”  Venetian Gardens, DAB No. 2286, at 9 (2009) (quoting St. Catherine’s Care Ctr. of Findlay, Inc., DAB No. 1964, at 13 (2005)).  This is just such a case.  We conclude that the ALJ erred in deciding this case on summary judgment.

Page 18

As we explain in section A of our analysis below, the record presents at least one dispute of material fact:  when on January 19 an acute or significant change in condition occurred.  This is the factual issue the ALJ aptly described as “pivotal.”  ALJ Decision at 8.  We agree with the ALJ that, in general, the parties do not dispute the timeline of events on January 19.  Also, at bottom, neither party disputes that R2 had an acute or significant change in condition that day.  However, the parties have expressed, mainly through the dueling statements of their witnesses, different views on the clinical significance of the events, as largely undisputed as the events themselves may be, as bearing on the question of whether R2 had an acute or significant change in condition earlier at or around 1:30 PM, or hours later.

Also, we are unable to conclude, without reservation or qualification, that the ALJ’s analysis is fully faithful to the summary judgment rules.  For one thing, the ALJ appears to have weighed the relative value of competing evidence and, as well, assessed the credibility and reliability of witness statements.  Moreover, we perceive the ALJ’s analysis, in some respects, as unbalanced and as focused on the less favorable parts of Petitioner’s evidence.  Viewing the record as favorably as we can for Petitioner, we conclude that a rational trier of fact could find that a registered nurse assessed R2 at or around 1:30 PM – thus undermining the key foundation for CMS’s case.

We need not identify every favorable inference the ALJ could have drawn but did not draw based on the admitted exhibits or every finding a rational factfinder could have made in Petitioner’s favor.  Nor must the Board catalog every instance of inappropriate assessment and weighing of competing evidence when vacating a summary judgment decision for error and remanding a case for re-adjudication.  Instead, we confine our discussion to the main reasons why we believe the ALJ’s analysis did not comport with the summary judgment standard.  Our discussion should not be construed as expressing or implying any opinion about the relative weight of competing evidence or the credibility of any witness whose declaration is of record; nor do we suggest any findings or conclusions the ALJ might or ought to make on re-adjudication.

We dedicate section B of our analysis to a discussion of the documents Petitioner submitted with its request for hearing but which we do not find among the exhibits the ALJ admitted and considered to decide this case.

The compliance issue for resolution on remand, following a hearing to permit cross‑examination of witnesses as the parties had requested, is whether the care Petitioner provided to R2 fell below the quality required under section 483.25 and whether that care, if deficient, posed a potential for more than minimal harm to resident health and

Page 19

safety.¹⁹  If so, then there is a basis for a deficiency finding, which CMS cited as Tag F684 and determined had posed immediate jeopardy to resident health and safety, and the imposition of a CMP.

Finally, in section C of our analysis, we explain our conclusion that the ALJ correctly determined, as a matter of law, that CMS’s scope and severity level finding is not reviewable under the circumstances of this case.

A.        The ALJ erred in deciding this case on summary judgment.

1. The existence of a disputed fact – when on January 19, 2019, R2 experienced an acute or significant change in condition – material to the issue of whether Petitioner complied substantially with 42 C.F.R. § 483.25 precludes decision on summary judgment.

Petitioner argues that the time when R2 experienced an acute or significant change in condition – and thus “the point at which a formal RN assessment [wa]s required” – is a disputed issue of material fact.  P. Br. to Board at 9, 11-12.  Petitioner charges that “the ALJ ignores genuine material facts presented in witness declarations supporting Petitioner’s appeal.”  Id. at 9.

A party may assert that a fact is disputed in reliance on record evidence including affidavits or declarations.  Laboratorio Concordia Lugaro, DAB No. 3029, at 10 (2021) (citing Fed. R. Civ. P. 56(c)).  “Although the Federal Rules of Civil Procedure do not apply by their own terms in this administrative proceeding, we are guided by those rules and by judicial decisions on summary judgment in determining whether the ALJ properly granted summary judgment.”  Columbia Care & Rehab. Ctr., DAB No. 2348, at 5 (2010).  Furthermore, while “[t]he appeals procedures in 42 C.F.R. Part 498, subpart D” governing SNF CMP cases “do not expressly provide for ALJs to decide cases on summary judgment,” ALJs and the Board “have long applied summary judgment principles in Part 498 appeals,” looking to Federal Rule 56 as guidance.  Emery Cnty., DAB No. 3006, at 6; see, e.g., Cedar Lake, DAB No. 2344, at 2; Va. Highlands Health Rehab. Ctr., DAB No. 2339, at 3 (2010).

A determination as to when a resident needs assessment by a registered nurse involves a degree of professional judgment by individuals with appropriate training, background, and experience who would be able to recognize, identify, monitor, and manage relevant 

Page 20

signs, symptoms, and changes in condition; understand their meaning and significance; and intervene as necessary as the resident’s condition evolves.  See generally Universal Healthcare/King, DAB No. 2215, at 17-18 (2008) (discussing the need for professional or nursing judgment in determining whether a resident is experiencing a significant change in status), aff’d, 365 F. App’x 532 (4th Cir. 2010); see also Final Rule, 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991) (discussing the need for “judgment . . . in determining whether a change in the resident’s condition is significant enough to warrant notification” and stating that “significant change” entails “deterioration in health, mental or psychosocial status in either life-threatening conditions . . . or clinical complications”).  Accordingly, evidence of professional judgment and related decision-making concerning a resident’s medical status, vital signs, symptoms, and other relevant clinical indications could be relevant and material even if the facts about the signs and symptoms themselves (such as R2’s temperature at a given time) remain largely undisputed.

The record reflects evidence of such professional judgment.  For CMS, Soldovieri, a registered nurse, testified that at approximately 1:30 PM on January 19, R2 had a significant change in condition for which a registered nurse should have assessed R2, but Petitioner did not provide such an assessment until hours later.  See CMS Ex. 14, at 2-6 (¶¶ 10-13).

In contrast, four witnesses for Petitioner testified that R2 did not have an acute change in condition until later in the afternoon on January 19.  See P. Ex. 3 (Declaration of Cain, a registered nurse), at 3 (¶ 14) (stating that R2 had an acute change in condition “[a]round 4:00 p.m.”); P. Ex. 7 (Declaration of Jonas, a family nurse practitioner), at 2 (¶ 11) (opining that “R2 did not experience an [acute change in condition] until after the third emesis occurred at approximately 4:00 p.m.”).  Cavers, Petitioner’s Administrator and COO, testified similarly.  P. Ex. 1, at 3-4 (¶ 16).  RN Wilhelm’s testimony is generally consistent with that of Cain, Jonas, and Cavers.  Wilhelm testified in part:

At approximately 1:15 p.m. on January 19, 2019, I was working at the nurse’s station outside of R2’s room in my capacity as the manager on duty. . . .  Based on my assessment of LPN-D’s report and R2’s elevated temp[erature], I directed LPN-D to take a pulse oxygen reading which LPN-D came back and reported at 82%.  Based on this reading, I concurred with LPN-D’s decision to start O2 at 2 liters and administer Tylenol for R2’s low grade fever. . . .

Based on R2’s vitals and according to standards of nursing practice, as well as my professional judgment as an RN, I did not determine that R2 was experiencing an acute change of condition (ACOC).

P. Ex. 8, at 1-2 (¶¶ 5-6).  We read Wilhelm’s testimony to mean that as of around 1:30 PM, Wilhelm did not perceive R2 as having had an acute change in condition.

Page 21

CMS asserts that the testimony of Petitioner’s witnesses who opined that R2 did not have an acute or significant change in condition at 1:30 PM “represented a conclusion” the witnesses drew based on their “individual opinion[s], not evidence of a disputed material fact that would preclude summary judgment.”  CMS Response Br. at 8-9.  According to CMS, in Senior Rehabilitation and Skilled Nursing Center, DAB No. 2300 (2010), aff’d, 405 F. App’x 820 (5th Cir. 2010), the Board rejected a SNF’s analogous argument that summary judgment was inappropriate because the SNF professionals’ affidavits created a factual dispute about whether the facility reasonably and timely notified a physician after a resident had a significant change in condition.  Id. at 9.  CMS relies on the following language on page 6 of Senior Rehabilitation:

Senior Rehab mistakes the conclusory opinions of its affiants for evidence of material fact.  Senior Rehab itself observes that the affiants for each side state that they reviewed the same survey findings, but reached opposite opinions.  This apt description in itself demonstrates why the case was suited for summary judgment—there was no genuine dispute of material fact, but opposing conclusions as to whether, applying the regulatory requirements to the undisputed facts, the facility was or was not in substantial compliance.

CMS Response Br. at 9 (quoting Senior Rehabilitation, DAB No. 2300, at 6 (internal quotation marks, citation, and emphasis omitted)).  According to CMS, here, as in Senior Rehabilitation, there is no dispute about the facts themselves, which the ALJ considered; the only dispute is about the conclusions to be drawn from them.  Id.

One issue presented in Senior Rehabilitation was whether the SNF reasonably and timely notified a physician about whether a resident experienced a significant change in condition in accordance with 42 C.F.R. § 483.10(b)(11).  See DAB No. 2300, at 7.  There, the treating physician opined that the SNF provided adequate care and kept him reasonably and timely informed about the resident’s care needs and changes in condition, and that the resident’s skin wounds were medically unavoidable.  Id. at 9.  The Board stated that the ALJ “accurately explained” that the physician’s statements were “conclusions reflecting the doctor’s individual opinion, not evidence of material facts.”  Id. at 10.  The Board also noted that the SNF “simply [did] not address whether [the resident’s] unplanned and substantial weight loss under the particular circumstances here evidenced a significant change in [the resident’s] health status under the regulation, nor [did] it explain how a delay of three weeks in even notifying [the physician] could be considered to comply with a standard requiring immediate consultation.”  Id.  Moreover, the Board noted, the SNF did not argue or proffer evidence that the resident’s unplanned and significant loss of weight within about a month was not a significant change in status or claim that notifying the physician more than three weeks after the SNF detected the weight loss qualified as an immediate consultation.  Id. at 10-11.  In rejecting the SNF’s argument that the opinions created factual disputes, the Board determined that the ALJ resolved all genuine factual disputes in the SNF’s favor, but still concluded, correctly,

Page 22

that summary judgment for CMS was appropriate based on material facts that the SNF did not dispute and which themselves were adequate to support a conclusion that the SNF did not comply with the regulations.  Id. at 5.

The “opinions” of Petitioner’s witnesses, however, are distinguishable from those of the physician in Senior Rehabilitation.  The declarations of Petitioner’s witnesses are based on a consideration of the underlying events that are largely undisputed.  Moreover, Soldovieri’s declaration, too, includes numerous “opinions,” including an opinion on the ultimate question of whether Petitioner complied with section 483.25.  CMS Ex. 14, at 3 (¶ 12) (“In my professional opinion, R2 did not receive treatment and care in accordance with professional standards of practice on January 19, 2019.”).  CMS does not address why we nevertheless ought to view the statements of Petitioner’s witnesses, but not those of CMS’s own witness, as merely conclusory opinions like those given by the physician in Senior Rehabilitation.  Stating that R2 did not manifest an acute or significant change in condition until around 4:00 PM as, for instance, Cain did, based on a combination of indications – multiple vomiting episodes and loose stools, abnormal lung sounds, and indications of respiratory distress evidenced by O2 level of 82% and elevated respiration of 50 (see P. Ex. 3, at 3 (¶¶ 14-15)) – is not like opining, as the physician in Senior Rehabilitation did, on the ultimate question of whether the SNF complied with the applicable notice requirement and provided the resident adequate care.  From our perspective, the very fact that multiple nursing professionals, including Soldovieri, reached different “conclusions” from the record evidence about when R2 had an acute or significant change in condition indicates that the parties do indeed disagree about a pivotal material fact.  Moreover, intertwined with such a dispute are diverging positions on the clinical significance of various signs and symptoms as they bear on the essential question of at what point a resident’s condition becomes serious enough that a full assessment by a registered nurse is appropriate or necessary.  In short, the dispute involves factual questions.

2. The ALJ appears to have assessed and weighed witness testimony, which is inappropriate on summary judgment.

A decision to resolve a case on summary judgment raises concerns where, as here, the factual finding an adjudicator must have made necessarily entailed consideration of dueling professional opinions.  See, e.g., Franklin Care Ctr., DAB No. 2869 (2018) (remanding case improperly decided on summary judgment when record contained conflicting expert testimony and disputes of material fact).  It would be difficult for the adjudicator to completely avoid any comparing and contrasting of such opinions that could very well entail an assessment of the credibility of the individuals giving the opinions or the reliability of their opinions.  See id. at 13 (“[D]isregarding or discounting the assertions of [an SNF’s] expert was necessarily an exercise in the assessing the credibility of, relative expertise of, and appropriate weight to accord to witnesses,” and “[s]uch an exercise precludes summary judgement.”). On summary judgment, the

Page 23

adjudicator must construe the record in the light most favorable to the non-movant, avoiding the temptation to decide which party’s facts are more likely to be true.  See Madison Health Care, Inc., DAB No. 1927, at 6 (2004).  Where the “evaluation of credibility or comparison of competing evidence is called for, summary judgment is inappropriate.”  Id. at 14; see also St. Catherine’s, DAB No. 1964, at 24 (stating that assessment of witness credibility is improper on summary judgment); Madison Health Care, Inc., DAB No. 2049, at 8 (2006) (“Credibility matters . . . only where resolving a material issue of fact depends on the accuracy, weight and believability of particular testimony.”).

The ALJ stated, “I am not weighing the opinion of . . . any . . . witness,” but that statement alone is not dispositive on the issue of whether such weighing took place.  See ALJ Decision at 16.  The ALJ Decision reflects a more extensive discussion of the declarations of Petitioner’s witnesses as compared to Soldovieri’s declaration.  Compare ALJ Decision at 12, 13, 14, 16, with id. at 12 (briefly discussing Soldovieri’s declaration).  On the one hand, such a discussion indicates the adjudicator thoroughly examined the evidence.  On the other hand, such a discussion, in the summary judgment context, raises concerns because the discussion could very well amount to assessment and weighing of the relative value of competing or conflicting testimony.  We are unable to conclude that the ALJ’s analysis is free of such an assessment and weighing, particularly when the more extensive discussion of Petitioner’s witness testimony largely served to explain why the ALJ was rejecting Petitioner’s arguments (see id. at 12, 13, 14, 16).  It also is problematic that the ALJ appears to have credited Soldovieri’s statements without having given Petitioner the requested opportunity to cross-examine Soldovieri.  See id. at 12.²⁰  “[E]valuating the conflicting opinions is an exercise that belongs in resolving the merits of the case based on the preponderance of the evidence after the record is complete, rather than in making a summary judgment on undisputed evidence.”  Vandalia Park, DAB No. 1939, at 13 (2004).

Page 24

Below, we address in more detail one instance where the ALJ appears to have weighed and then rejected, or at minimum discounted, testimony of witnesses for Petitioner.  Under these circumstances, we are unable to conclude, without reservation or qualification, that the ALJ’s analysis is free from improper assessment and weighing of evidence in the moving party’s favor.

The ALJ considered multiple “complicating factors,” to include history of dysphasia, swallowing precautions, and risk of aspiration, which the ALJ determined increased the risk of harm associated with vomiting.  See ALJ Decision at 12 (citing CMS Ex. 14 (Soldovieri Decl.), at 4); see CMS Ex. 14, at 4 (¶¶ 12.e, 12.f) (Soldovieri’s testimony that R2 was diagnosed with dysphasia and had a history of aspiration pneumonia, which “put R2 at a higher risk of another episode of aspiration pneumonia”).  The ALJ also determined that, considering the emergency room diagnoses of pneumonitis due to inhalation of food and vomit, severe sepsis with septic shock, and acute respiratory failure with hypoxia, “there was a significant risk of serious harm from a failure to perform a timely and thorough assessment by an RN . . . at 1:30 PM.”  ALJ Decision at 12 (emphasis omitted) (citing CMS Ex. 1 (Statement of Deficiencies), at 8).  Thus, evidently relying in part on Soldovieri’s testimony, the ALJ determined that Petitioner should have had a registered nurse assess R2 at 1:30 PM but did not do so.

However, Petitioner asserted that Wilhelm, a registered nurse, did assess R2’s vital signs at 1:30 PM, and then ordered oxygen at 2 liters and administration of Tylenol, because Wilhelm considered LPN-D’s report that R2 had a low-grade fever, second emesis, and a pulse oxygen reading of 82%.  See ALJ Decision at 14 (citing P. Ex. 8 (Wilhelm Decl.), at 1-2).  On this, the ALJ stated:

Concededly, this could be considered some manner of “assessment.”  However, this is not found to be a complete assessment by an RN because she did not make her own observations, did not personally examine the resident, and, in fact, did not physically observe the resident.

Id.

We perceive this rationale as an assessment and rejection or discounting of Wilhelm’s testimony as less than reliable because Wilhelm did not personally assess R2 and thus did not have first-hand knowledge of R2’s condition.  In doing so, the ALJ also arguably rejected or discounted the testimony of Cavers and Cain, because they testified similarly, agreeing with Wilhelm.  See P. Ex. 1, at 3, 5 (¶¶ 16.b, 17.d); P. Ex. 3, at 4 (¶ 21.b).  Moreover, as noted, the ALJ appears to have relied at least in part on Soldovieri’s testimony to determine that Petitioner failed to have a registered nurse assess R2 at 1:30 PM, and yet Soldovieri could not have personally observed or assessed R2 because she

Page 25

performed the survey in March 2019, after R2 died.²¹  While Wilhelm evidently did not personally observe or assess R2 around 1:30 PM, Wilhelm explained what she, as a registered nurse, determined would be appropriate for R2 at the time, based on information given directly to her by LPN-D, who had direct, personal contact with R2.  See P. Ex. 8, at 1-2 (¶ 5).

3. Viewing the record in the light most favorable to Petitioner, a rational trier of fact could make a finding for Petitioner that would undercut CMS’s case.

A “dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”  Guardian Health Care Ctr., DAB No. 1943, at 11 (2004) (citing Vandalia Park, DAB No. 1939), appeal dismissed per stipulation, No. 06-3221 (6th Cir. Aug. 11, 2006).  In challenging summary judgment for the movant, the SNF, as non-movant, need only show that a rational trier of fact could decide for the SNF “under the most favorable, reasonable construction of the proffered evidence.”  St. Catherine’s, DAB No. 1964, at 10.  The SNF “is not required to convince the decisionmaker that its evidence is more persuasive or credible than [the movant’s] evidence.”  Va. Highlands Health Rehab. Ctr., DAB No. 2339, at 8 (2010).

CMS does not convince us that the “undisputed facts” about the events on January 19, viewed in the light most favorable to Petitioner, demands only one conclusion that, as a matter of law, Petitioner did not comply substantially with section 483.25 because it failed to have a registered nurse assess R2 at 1:30 PM when R2 had an acute or significant change in condition.  See CMS Response Br. at 2.  Petitioner has shown that a factfinder could make a finding favorable to it.

Cain testified that, in her opinion, Wilhelm’s consultation with and instructions to LPN-D at around 1:30 PM (discussed above) constituted an assessment by a registered nurse.  See P. Ex. 3, at 2-3, 4 (¶¶ 10-12, 21.b).  Cavers testified similarly.  See P. Ex. 1, at 5 (¶ 17.d).  Soldovieri, however, testified to the effect that Petitioner did not have a registered nurse assess R2 at 1:30 PM.  See CMS Ex. 14, at 3-4 (¶¶ 12.c, 12.d, 12.f).

In our view, it is conceivable that a factfinder could favorably view the record materials, including the declarations of Petitioner’s witnesses, and determine that a registered nurse assessed R2 around 1:30 PM.  Such a finding would be fatal to CMS’s case by rendering moot the dispute about exactly what time on January 19 – that is, at or around 1:30 PM or later – R2 manifested signs and symptoms supporting an acute or significant change in

Page 26

condition.  Where, as here, “the record evidence is susceptible of a rational interpretation which would preclude summary judgment against the non-movant party, the case must go forward for a thorough evaluation of what the most reasonable inferences and the preferable interpretations are based on all credible evidence in the record after a full hearing.”  Madison, DAB No. 1927, at 14.

4. The ALJ Decision suggests the ALJ could have viewed, but did not view, the record evidence more favorably for Petitioner.

“[I]n ruling on a motion for summary judgment, an ALJ must consider whether the record as a whole could lead a rational trier of fact to find for the non-moving party, viewing the evidence in the light most favorable to that party and drawing all reasonable inferences in that party’s favor.”  NMS Healthcare of Hagerstown, LLC, DAB No. 2803, at 17 (2017); see also Venetian Gardens, DAB No. 2286, at 16 (“[I]n the context of summary judgment . . . an ALJ must draw all reasonable favorable inferences on behalf of the nonmoving party[.]”).  In addressing findings that turned on the disputed interpretation of a resident’s progress notes, for example, the Board has held that “[d]rawing an inference from or determining the interpretation of these notations is precisely the kind of thing that the ALJ was not permitted to do on summary disposition so long as alternative inferences or interpretations existed that were more favorable to” the facility.  Madison, DAB No. 2049, at 10.  If an ALJ could have viewed the evidence favorably for the non-movant, the ALJ must have done so.  See St. Catherine’s, DAB No. 1964, at 28 (stating that inferences favorable to the movant may not properly be drawn, even from undisputed facts, if there is evidence from which a rational trier of fact could reasonably draw a contrary inference).

The ALJ assertedly found that R2 did not receive treatment and care from Petitioner in accordance with professional standards of practice “[a]fter reviewing the entire record in the light most favorable to Petitioner,” but again, that mere assertion is not dispositive.  See ALJ Decision at 16.  The ALJ’s analysis instead reflects an unbalanced discussion of certain evidence that could and should have been viewed more favorably for Petitioner.  We discuss one such instance, concerning the context in which the events in the afternoon of January 19 took place.

The ALJ noted that, around 1:30 PM, R2’s O2 level dropped from a baseline level to 82% and her temperature increased to 100.6º F, and that R2 was observed to be congested and had vomited at least twice and had at least one loose stool.  ALJ Decision at 10-11 (citing CMS Ex. 8, at 3; CMS Ex. 6).  The ALJ determined that these findings indicated an acute or significant change in condition, for which R2 “required medical intervention to avoid complications and to attempt to resolve the condition, as evidenced by the fact that interventions, in the form of oxygen and Tylenol, were provided.”  Id. at 11.

Page 27

We do not suggest that a decreased oxygen level, together with increased temperature and other concerns noted around 1:30 PM, are unremarkable or insignificant developments.  For instance, regarding the significance of a decreased oxygen level, the Board has stated that “[t]he nearly 30% drop in [the resident’s] oxygen saturation level immediately after the [resident’s] fall . . . indicated that [the resident] had suffered a traumatic injury.”  Emery Cnty., DAB No. 3006, at 12 (cited in ALJ Decision at 11).  The Board also has recognized that even “slow or subtle” changes could develop into a “significant” change in condition.  Universal Healthcare/King, DAB No. 2215, at 17-18.  Moreover, we cannot disagree with the ALJ that giving oxygen and Tylenol were “interventions,” as no doubt Petitioner provided them to manage or improve R2’s condition at that time.

However, at that time, Petitioner evidently was also managing incidences of norovirus with “isolation protocols” and it put residents, including R2, on its “24-hour board” for continuity of care and ongoing monitoring and assessment for stomach virus symptoms.  See P. Ex. 1, at 2 (¶ 9); P. Ex. 3, at 2 (¶ 11).  The record does not address whether Petitioner determined, upon testing or evaluation, that R2 in fact had a “stomach virus” that was determined to have been norovirus.  However, the record includes a timeline of “Outbreak 1/17/19 to 2/3/19,” which refers to a “resident” (presumably R2) who “presented with vomiting, fever, and diarrhea” on “1/19/19.”  See CMS Ex. 11, at 1; see also id. at 2 (a list of residents, including R2’s name with a notation of onset of vomiting, diarrhea, and fever on January 19).  As the ALJ noted, around 1:30 PM on January 19, the facility started administering oxygen at 2 liters, gave R2 Tylenol, and put R2 in isolation due to norovirus concerns.  ALJ Decision at 5.  Additionally, as discussed, RN Wilhelm, the manager on duty, testified that she was aware that R2 had an elevated temperature around that time, directed LPN-D to take a pulse oxygen reading and, thereafter, agreed with LPN-D to start oxygen at 2 liters and administer Tylenol.  P. Ex. 8, at 1-2 (¶¶ 5-6).  Aware of R2’s vital signs and the norovirus situation the facility was dealing with at the time, Wilhelm “did not determine” that R2 was experiencing an acute change in condition at that time.  Id. at 2 (¶ 6).

One favorable reading or inference to be drawn from the evidence discussed above would be that Petitioner’s nursing professionals decided at that time that isolating R2 while providing oxygen and Tylenol would be the most appropriate way to manage R2’s symptoms and manifestations indicative of a “stomach virus” or norovirus, while taking action appropriate or necessary for other affected residents.  Because we must view the evidence in the light most favorable to Petitioner, we do not read the records about the “stomach virus” as evidence of Petitioner’s awareness or acknowledgment that R2 had an acute or significant change in condition early in the afternoon on January 19.  Construing the administration of oxygen and Tylenol as supporting (in part) a finding that an acute or significant change in condition had manifested at 1:30 PM, as the ALJ appears to have determined (see ALJ Decision at 11), is not, from our perspective, the only view an adjudicator could have taken, and appears to require the drawing of an inference against Petitioner.  In the summary judgment context, such an inference is impermissible.

Page 28

Vandalia Park, DAB No. 1939, at 19 (“[A]ll reasonable inferences must be drawn in [a non-movant’s] favor in the summary judgment process.”)

B.        Petitioner submitted relevant documents with its request for hearing that are not among the admitted exhibits and which warrant examination on remand.

Petitioner submitted documents with its request for hearing.  Later, the parties submitted exhibits to the ALJ, and the ALJ admitted all of them.  However, some of the documents Petitioner submitted earlier with its request for hearing were not among the exhibits the parties later submitted, and the ALJ admitted.  Petitioner could and should have re‑submitted the documents submitted with its request for hearing as exhibits if Petitioner wanted the ALJ to consider them as part of the evidentiary record.  The ALJ apparently considered the parties’ briefs and the admitted exhibits, but not the documents submitted with the request for hearing, to decide this case.²²

The documents submitted with the request for hearing, but not included among the admitted exhibits, are:

• Records concerning informal dispute resolution proceedings following the survey that resulted in CMS’s determination that Petitioner did not comply substantially with 42 C.F.R. § 483.25.  CRD Docket C-19-922, DAB E-File entries 1a and 3a.
• Resident care policy titled “Policy and Procedure” and the “subject” of which is “Notification of Resident’s Change in Status,” with an effective date of July 2003, revised three times since then, and evidently in place on January 19, 2019.  CRD Docket C-19-922, DAB E-File entry 1b (an 85-page PDF document, which we refer to as “PDF Document”), PDF pages 25-26.
• “Emergency Care Do Not Resuscitate Order (DNR)” for R2.  PDF Document, PDF page 66.
• Typed one-paragraph report of the verbal statement given by N.H. (referred to as RN-R), whose name appears in the facility records concerning the care given to R2 on January 19, to Cain.  PDF Document, PDF page 74.

Page 29

• A record titled “Vitals Report” concerning R2’s condition on January 19.  PDF Document, PDF page 78.

The parties evidently do not have a dispute about the informal dispute resolution proceedings; however, the remaining four documents identified above merit some discussion.  We address them separately below.  Our discussion of these documents should not be construed as the Board’s assessment of their weight or the merits of any argument made to date.  We discuss the documents to bring the ALJ’s and the parties’ attention to additional potential evidence in furtherance of establishing a comprehensive record.  On remand, the ALJ should consider asking Petitioner to re-submit relevant, non‑duplicative records for admission into the evidentiary record and giving CMS an opportunity to object to them.

1. Resident Policy

The “Policy Statement” portion of the resident policy document reads:

To ensure the highest standard of practice, assessment of residents experiencing an acute change in condition will be done ASAP. . . .  Changes in condition include, but are not limited to all incidents, with or without injury, abnormal lab values, changes in physical, mental or psychosocial status, medication changes or significant medication errors.

PDF Document, PDF page 25.  The “Procedure” section of the policy, which sets out instructions on notification of the resident’s physicians, and consultations with them, about events or developments involving the resident, describes “[a] significant change in the resident’s physical, mental, or psychosocial status” as meaning “a deterioration in health, mental or psychosocial status in either life-threatening conditions or clinical complications.”  Id.

The resident policy addressing changes in status is relevant to determining whether Petitioner met the quality-of-care standard in section 483.25.  Absent evidence to the contrary, it is reasonable to presume that a SNF’s resident policy reflects the applicable professional standards of quality to which the SNF has committed.  See Perry Cnty. Nursing Ctr., DAB No. 2555, at 9 (2014); Spring Meadows, DAB No. 1966, at 17 (stating that CMS may “rely on” the facility’s policy to assess compliance with section 483.25 because, although the regulation “does not specifically require” a facility policy, “[t]he regulatory approach gives facilities flexibility in the structure and procedures used to ensure that residents receive the described services”); Laurels at Forest Glenn, DAB No. 2182, at 18 (2008) (stating that resident care policies may evidence both what a SNF expects its staff to do to comply with section 483.25 and an applicable professional standard of care).  “When a facility adopts a policy that calls on the nursing staff to take affirmative actions to safeguard resident health and safety, it is reasonable to infer (in the

Page 30

absence of evidence to the contrary) that the facility did so because such actions are necessary to attain or maintain resident well-being.”  Spring Meadows, DAB No. 1966, at 20; see also Sheridan, DAB No. 2178, at 15 (stating that “CMS may reasonably rely on a facility policy as evidence of the [facility’s] own judgment as to what must be done” to comply with section 483.25).  Accordingly, a facility’s failure to follow its own policy can support a section 483.25 deficiency.  See Lakeridge Villa Health Care Ctr., DAB No. 1988, at 22 (2005) (citing Board decisions), aff’d, 202 F. App’x 903 (6th Cir. 2006).

2. “Do Not Resuscitate” Order

The “Emergency Care Do Not Resuscitate Order (DNR)” bears 2016 signatures that appear to be those of R2’s legal guardian or health care agent and R2’s attending physician.  PDF Document, PDF page 66.  It sets out certain services emergency medical service providers will provide as appropriate, and those they will not provide, “in situations where death may be imminent.”  Id.  It states:  “The patient and the legal guardian or health care agent of an incapacitated patient have the right to revoke these restrictions on care at any time.”  Id. (bolding in original removed).

The ALJ Decision does not indicate that the ALJ reviewed and considered the DNR order when assessing Petitioner’s arguments relating to it; instead, the ALJ addressed Petitioner’s arguments in reliance on Jonas’s declaration.  As the ALJ noted, Jonas stated that, given that R2 had a signed “DNR/DNI” order, had R2’s daughter (health care agent) not insisted that her mother be sent to the emergency room, Jonas would have ordered Ativan and Morphine be given to R2 and worked with R2’s physician to have R2 remain and receive care at Petitioner’s facility in accordance with her wishes.  ALJ Decision at 16 (citing and discussing Jonas’s declaration, P. Ex. 7, at 2).  The ALJ found “obvious problems with this argument,” including that “it is a large leap to interpret a DNR/DNI order as a ‘do not treat’ order.”  Id.  Notably, the ALJ also stated that “[a]bsent evidence that the health care agents were not duly authorized to act on [R2’s] behalf, of which there is none in the record, it is inappropriate and insensitive to question their decision to request that their mother be sent to the ER for evaluation and treatment.”  Id.  While the DNR order was not admitted into evidence as an exhibit, it was a component of the record nevertheless, with potential relevance to assessment of Petitioner’s arguments concerning the order’s proper interpretation and effect.

3. Statement of N.H. (RN-R)

RN N.H. reportedly stated, in part, that around 3:00 PM (the date is not given, but apparently on January 19, 2019), R2 “appeared comfortable and in no apparent distress” and “was connected to oxygen.”  PDF Document, PDF page 74.  N.H. also reportedly stated that “around 4pm or shortly after,” N.H. was instructed to assess R2 “following a change of condition.”  Id.  N.H. reportedly stated that R2’s “lung sounds had rhonc[h]i present and that her spO2 was 82%.”  Id.  N.H. also allegedly reported that she called an

Page 31

Optum Care nurse practitioner and received orders to send R2 to the emergency room for evaluation.  Id.

The report does not indicate when RN N.H. verbally gave her statement to Cain or when that statement was memorialized in the typed report.  Nevertheless, the report includes additional relevant evidence concerning the events in the afternoon of January 19.

4. Vitals Report

The Vitals Report contains information potentially relevant to the timing of symptoms that could have alerted Petitioner to a significant change in R2’s condition.  The Vitals Report indicates that on the morning of January 19, 2019, R2 had a pulse of 66 per minute, and a large, loose bowel movement.  PDF Document, PDF page 78.  R2 had another large, loose bowel movement noted at 3:49 PM.  Id.  At or around 4:10 PM, R2 had a temperature of 98.5º F, pulse at 123 per minute (acceptable range: 50-100), respirations at 50 per minute (acceptable range: 12-28), blood pressure at 157/65 mmHg, and O2 saturation at 82% on 4 liters of oxygen (acceptable range: 90-100%).  Id.

The Vitals Report thus potentially bears on the ALJ’s factual findings and ultimate conclusions.  For example, the ALJ stated that the progress notes for the period from 3:50 PM to 4:10 PM on January 19 “do not contain any record of [R2’s] temperature.”  ALJ Decision at 6 n.11 (citing CMS Ex. 8, at 2-3).  However, as the ALJ also indicated, at approximately 3:50 to 4:10 PM, the facility assessed R2 for, among other things, temperature, which was noted as 98.5º F.  Id. at 6.  The Vitals Report, which appears to indicate that the facility took R2’s vitals during that period, reflects, among other things, that R2 had a temperature of 98.5º F around that period, as the ALJ indicated.  The Vitals Report also indicates that R2’s respiration was 50 at 4:31 PM, as the ALJ noted.  See PDF Document, PDF page 78; ALJ Decision at 11 n.17 (citing CMS Ex. 8, at 2, 3).  In describing “new and concerning findings” at or around 1:30 PM, the ALJ noted that R2 was experiencing, inter alia, “loose stools.”  ALJ Decision at 11.  However, the Vitals Report indicates R2 had “loose” stools at or just before 9:58 AM.  See PDF Document, PDF page 78.  Based on the Vitals Report, the loose stools noted at or around 1:30 PM itself apparently was not the first or “new” instance of such an event on January 19.

C.        The ALJ did not err in concluding as a matter of law that CMS’s scope and severity findings are not reviewable.

As the ALJ correctly stated, an ALJ “may review CMS’s scope and severity findings, which include a finding of immediate jeopardy, only if a successful challenge would affect the range of the CMP assessed or CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide training program.”  ALJ Decision at 3 (emphasis omitted) (citing 42 C.F.R. § 498.3(b)(14), (d)(10)).

Page 32

Neither condition is met in this case.  A successful challenge of the immediate jeopardy finding could not affect the range of the CMP that CMS could collect because the regulations provide for only a single range of CMP amounts for a per-instance CMP.  ALJ Decision at 3 (citing 42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (as amended effective Oct. 11, 2018); 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018)).  As for whether CMS made a finding of substandard quality of care that could affect approval of a facility’s nurse aide training program, the ALJ stated:

Nor does CMS’s scope and severity finding affect approval of a nurse aide program.  There is no evidence that Petitioner had a nurse aide training program.  However, even if it had, when a facility has been assessed a CMP of $10,697 or more, as has occurred here, the state agency may not approve its nurse aide training program.

Id. (citing 42 C.F.R. § 483.151(b)(2)(iv)).  We perceive no error in that assessment.²³

Finally, even were the scope and severity determination reviewable and at issue here, ALJs and the Board “must” uphold CMS’s immediate jeopardy determination unless it is “clearly erroneous” – a highly deferential standard.  See 42 C.F.R. § 498.60(c)(2); Maysville Nursing & Rehab. Facility, DAB No. 2317, at 11 (2010); Yakima Valley Sch., DAB No. 2422, at 8 (2011) (citing cases).

Page 33

Conclusion

We vacate the ALJ Decision and remand the case to the ALJ.  On remand, the ALJ should first further develop the record.  Such development is to include, at minimum, a hearing during which the parties may cross-examine the witnesses.  The ALJ also may further develop the record as the ALJ determines is appropriate or necessary in accordance with the authority conferred to the ALJ by the regulations in 42 C.F.R. Part 498, subpart D, as well as any applicable Civil Remedies Division and/or ALJ procedures.

The ALJ should thereafter issue a decision, determining whether Petitioner did, or did not, substantially comply with 42 C.F.R. § 483.25 (Tag F684).  If the ALJ concludes that Petitioner was not in substantial compliance with section 483.25, the ALJ should determine whether the per-instance CMP imposed for Tag F684 is reasonable.

Endnotes

¹ The Guidelines are accessible at:  https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/participation/index.html.

² We apply the regulations in effect when the surveys were performed that supplied the findings on which CMS’s enforcement action was based.  See Copperas Cove LTC Partners, Inc., DAB No. 3049, at 2 n.1 (2021), appeal dismissed, No. 21-60892, 2023 WL 4198882 (5th Cir. June 27, 2023).

³ We cite the PDF pages of the SOM accessible on the CMS website through this link.

⁴ The quoted prefatory language of section 483.25 has been in effect since November 28, 2016.  See Final Rule, 81 Fed. Reg. 68,688, 68,860 (Oct. 4, 2016).  The prefatory language that was in effect from April 1, 1992 to November 27, 2016 read 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.”  See Final Rule, 56 Fed. Reg. 48,826, 48,873 (Sept. 26, 1991).  We cite Board decisions discussing the scope and meaning of the prefatory language of section 483.25 in effect before the 2016 revision.  The Board’s analysis of the older language is pertinent because, despite undergoing revision, the prefatory language, old and revised, consistently conveys the substance of, and the core guiding principle underlying, section 483.25—that SNFs must provide quality care that meets each resident’s needs.  We also note that the SOM provisions in effect after the 2016 revision and during the surveys and CMS’s imposition of a CMP here emphasize the importance of prioritizing a resident’s “highest practicable physical, mental and psychosocial well-being,” thus echoing the earlier iteration of section 483.25’s lead-in language.  See SOM, App. PP, guidance for Tag F684 (Rev. 173, Effective Nov. 28, 2017), PDF pages 282 and 283.

⁵ Petitioner evidently has a written resident policy on change in condition.  That policy was one of multiple records Petitioner submitted with its request for hearing, but Petitioner did not resubmit some of those records (including the resident policy) as exhibits for admission into the evidentiary record.  Accordingly, the evidentiary record on which the ALJ (who admitted all proposed exhibits) rendered the decision did not include the resident policy.  In section B of our analysis, we will discuss the resident policy and certain other documents submitted with the request for hearing but not found among the admitted exhibits as relevant to the issue of whether Petitioner complied substantially with 42 C.F.R. § 483.25, for further consideration on remand.  Considering Petitioner’s consistent representation that it followed AMDA Guidelines, we infer Petitioner’s position to be that its resident policy is consistent with the AMDA Guidelines.

⁶ This case does not arise from an allegation that Petitioner did not report, or reported late, any development or event concerning a resident.  In citing Tag F684, CMS does not assert that Petitioner violated any reporting regulation or standard.  See, e.g., 42 C.F.R. § 483.10(g)(14).  Nevertheless, in this subsection, we note AMDA Guidelines provisions that discuss reporting (including timing of reporting) of certain clinical indications because they may be instructive here to the extent they address which indications, and under what circumstances, present greater or lesser urgency for purposes of determining appropriate or necessary nursing intervention.  Our discussion of the AMDA provisions in this subsection should not be construed as the Board’s finding or implying that Petitioner did not adhere to any reporting provision in the regulations or the AMDA Guidelines.

⁷ We set out here only a summary of the key events of January 19, 2019, based on the parties’ exhibits, all of which the ALJ admitted, for context for the discussion to follow.  Our summary is not to be construed as the Board’s findings of fact.  The ALJ is to make factual findings on remand.

⁸ The ALJ noted that the only written reference to this assessment was found in an Optum Care call record documenting the call from Petitioner’s nurse.  ALJ Decision at 5 n.6 (citing CMS Ex. 6).  However, the ALJ stated, “it is accepted as accurate.”  Id.  This is one of several instances in which the ALJ indicated the ALJ would view the record evidence favorably for Petitioner.

⁹ As the ALJ noted, the progress notes indicate that at 1:30 PM, R2 had two large vomiting episodes and two large loose bowel movements.  However, the ALJ accepted that R2 had one loose bowel movement at that time.  ALJ Decision at 5 n.7 (stating, “for purposes of summary judgment, I am accepting the factual description provided by Petitioner”); CMS Ex. 8, at 3.

¹⁰ The ALJ noted the absence of record of administration of Tylenol in the progress notes.  ALJ Decision at 5 n.9 (citing CMS Ex. 8, at 3).  However, the ALJ accepted that Petitioner administered Tylenol.  Id.

¹¹ Deficiencies are assigned scope and severity levels, designated by one of 12 letters (A–L), and are used to select remedies.  See SOM, Ch. 7, § 7400.3.1 (Rev. 185, Effective Nov. 16, 2018); see also 42 C.F.R. § 488.408.

¹² Concerning Tag F684, the Statement of Deficiencies indicates that Petitioner “removed” immediate jeopardy on “2/28/19.”  CMS Ex. 1, at 3.  We read the record evidence to mean that CMS determined that immediate jeopardy was present through February 27, 2019, and that Petitioner no longer had an immediate jeopardy deficiency as of February 28, 2019.  See CMS Ex. 3, at 1 (stating that the “First Day of IJ” was “01/19/2019” and the “Last Day of IJ” was “02/27/2019”); CMS Ex. 4, at 1 (similar notation).

¹³ Petitioner did not challenge the deficiency alleging noncompliance with sections 483.25(d) (Tag F689).  In any case, the ALJ determined the ALJ could not review it because CMS imposed no penalty for Tag F689.  ALJ Decision at 3 (citing 42 C.F.R. § 498.3(d)(10)(ii) and Schowalter Villa, DAB No. 1688 (1999)); see Fountain Lake Health & Rehab., Inc., DAB No. 1985, at 5 (2005) (noting that in the preamble in 59 Fed. Reg. 56,116, 56,158 (Nov. 10, 1994), “CMS concluded that, absent a remedy being imposed, the deficiency findings alone do not result in harm such as to create a right to a hearing”); Arcadia Acres, Inc., DAB No. 1607 (1997) (affirming ALJ’s dismissal of request for hearing on grounds that the SNF was not entitled to a hearing where CMS imposed no remedy).

¹⁴ The record reveals no further communication between the ALJ’s office and the parties concerning the subpoena requests.  We assume the hospital and ambulance company produced records before Petitioner submitted its brief and exhibits.  In May 2021, after the subpoenas were issued, the case was transferred to a different ALJ who issued the decision now before the Board.  ALJ Decision at 2 n.2.

¹⁵ The record of the ALJ proceedings uses the words “significant,” as well as “acute” (used in the AMDA Guidelines), in referring to change in condition.  The ALJ noted that Petitioner used the terms “significant” and “acute” interchangeably.  ALJ Decision at 8 n.12 (citing P. Pre-Hearing Brief at 4).  Thus, Petitioner does not assert   that one word is materially distinguished from the other when discussing any change in R2’s condition.  Also, notably, neither party disputes that, for purposes of compliance with section 483.25 in the context of this case, any change in condition must be “significant” (or “acute”).  However, as discussed later, Petitioner asserts that the parties have different views about what signs, manifestations, and circumstances are “significant” (or “acute”) to trigger the need for assessment by a registered nurse.

¹⁶ Soldovieri stated, “An LPN typically does not have the level of education necessary to conduct an assessment of a patient.  Rather, an LPN works under the supervision of an RN.  An LPN may obtain and record a patient’s vitals, and the LPN is responsible for reporting any changes in condition to an RN so that an assessment may be conducted if necessary.”  CMS Ex. 14, at 3 (¶ 12.d).  Petitioner does not dispute these statements.

¹⁷ Whether Petitioner followed up with Optum Care or reported abnormal or concerning signs to anyone by a certain time is not in and of itself the relevant compliance question.  However, any failure to adhere to certain established protocols for communicating with Optum Care could be relevant to the extent that failure bears on Petitioner’s obligation to meet section 483.25’s quality-of-care standards.

¹⁸ Petitioner requested “to appear before the Board to present oral arguments” (P. Br. to Board at 1) but did not state a basis for its request.  Under the Guidelines, which were provided to the parties with the ALJ Decision, a party wishing to present oral argument should request it no later than the time for filing the party’s last submission (meaning, for Petitioner, the reply brief) and state the purpose of the requested appearance.  See Guidelines, “Development of the Record on Appeal,” ¶ (f); Board’s Oct. 15, 2021 letter at 2.  In its reply brief, Petitioner did not address its earlier request for oral argument.  The Board may grant a request for oral argument if necessary to give the parties a “reasonable opportunity” to present the case in accordance with 42 C.F.R. § 498.85.  The Board may also hold oral argument if it concludes that oral argument may enhance its decision-making.  See W. Tex. LTC Partners, Inc., DAB No. 2652, at 2 n.1 (2015), aff’d, 843 F.3d 1043 (5th Cir. 2016).  We construe Petitioner’s silence in its reply brief about its earlier request for oral argument to mean that Petitioner no longer wants to present oral argument and has presented all arguments in writing.  We conclude that oral argument is not necessary and deny the request.  We proceed to decision based on the written submissions.

¹⁹ The regulations do not require a finding that an instance of noncompliance caused actual harm, even for an immediate jeopardy noncompliance.  See 42 C.F.R. § 488.301 (defining “substantial compliance” and “noncompliance”).  They do permit a finding of noncompliance based on evidence of a “potential” for more than minimal harm and a finding of immediate jeopardy based on evidence that the deficiency is “likely to cause” serious harm (or death).  See id.

²⁰ Surveyors are professionals who undergo required training to assess compliance with participation requirements.  See 42 C.F.R. §§ 488.26(c)(3), 488.314.  An ALJ may rely on surveyor testimony as to the applicable professional standard to determine whether a facility met that standard if “‘the evidence shows that the surveyor has training, experience and knowledge in the subject field.’”  Perry Cnty. Nursing Ctr., DAB No. 2555, at 9 (2014) (quoting Universal Health Care - King, DAB No. 2383, at 8 (2011), aff’d, 499 F. App’x 299 (4th Cir. 2012)), aff’d, 603 F. App’x 265 (5th Cir. 2015); see also Bardstown, DAB No. 2479, at 20 (citing Board decisions and stating that “[i]t is well settled that an ALJ may rely on a surveyor’s expertise as to applicable standards of professional care where the evidence shows that the surveyor has training, experience and knowledge in the subject field”).  The fact that a nurse-surveyor might not be actively engaged in nursing but in survey activities would not itself render that individual unqualified to discuss or express opinions about applicable nursing practices or standards.  See Residence at Salem Woods, DAB No. 2052, at 7-8 (2006) (rejecting argument that nurse surveyors’ lack of recent clinical experience rendered the surveyors unqualified to discuss or express opinions about nursing practices or standards), appeal dismissed per stipulation, No. 07-3001 (6th Cir. Jan. 30, 2007).  Petitioner has not asserted that Soldovieri, a registered nurse who, at the time of her declaration, had worked as a nurse consultant/surveyor for 15 years and as a nursing home administrator for 16 years before then (see CMS Ex. 14), is not qualified to speak to the relevant standard and whether Petitioner met it due to the lack of relevant training, experience, and knowledge.  However, that aside, the ALJ’s analysis is concerning because Petitioner, too, has offered testimony of registered nurses who also evidently have relevant training, experience, and knowledge, and CMS has not asserted otherwise.

²¹ We see nothing in the record indicating that Soldovieri assessed R2 or had any contact with R2.  We will infer, in Petitioner’s favor, that Soldovieri first learned about R2 and the events of January 19, 2019 in March 2019, in the course of performing the survey.

²² Because we vacate the ALJ Decision and remand this case for further development and the issuance of a new decision, neither party is prejudiced by the ALJ’s earlier issuance of a decision without the benefit of consideration of the documents submitted with the request for hearing.  We also note that, even assuming Petitioner had re-submitted all of the documents submitted with its request for hearing as exhibits, the ALJ need not have ruled on the admission of exhibits to resolve a motion for summary judgment.  However, in that situation, the exhibits may be “‘properly treated as an offer of proof, that may be evaluated if necessary to determine whether a genuine issue of material fact exists’” to determine whether summary judgment would be appropriate.  See Illinois Knights Templar Home, DAB No. 2274, at 6 (quoting Lackawanna Med. Grp. Lab., DAB No. 1870, at 14 (2003)).

²³ We do not construe the quoted language in the ALJ Decision to have meant that a “scope and severity finding” categorically cannot have any effect on a SNF’s ability to operate a nurse aide training program.  An immediate jeopardy finding indeed can have such an effect.  The term “Substandard quality of care” is defined to include “one or more deficiencies related to participation requirements under . . . § 483.25 of this chapter ‘Quality of care’ . . ., which constitute . . . immediate jeopardy.”  42 C.F.R. § 488.301.