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                              Valley House Rehabilitation Center, DAB CR6020 (2022)
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Valley House Rehabilitation Center, DAB CR6020 (2022)








  
  
    

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





Valley House Rehabilitation Center,
(CCN: 05-6069),
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-19-957Decision No. CR6020January 25, 2022

        
              
    

      DECISION

On the morning of November 9, 2018, an exceptionally fragile nursing home resident fell in the shower room.  Throughout the day, facility staff gave her Tylenol; she nevertheless experienced breakthrough pain and other disturbing symptoms.  That evening, she died of cardiovascular disease, complicated by the blunt force pelvic injury caused by her fall.  We consider here whether, during her last hours, the facility provided her the care and services she needed.

Petitioner, Valley House Rehabilitation Center, is a long-term-care facility, located in Santa Clara, California, that participates in the Medicare program.  Based on a complaint investigation, completed on May 14, 2019, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements governing quality of care.  Based on this finding, CMS imposed a per-instance civil money penalty (CMP) of $10,696 for each of two deficiencies cited (total penalty of $21,392).

Petitioner appealed, and the parties have agreed that this case may be decided on the written record.

**Page 2**

For the reasons discussed below, I find that that the facility was not in substantial compliance with Medicare program requirements and that the penalties imposed are reasonable.

Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

Here, responding to a complaint, surveyors from the California Department of Public Health (state agency) visited the facility to investigate, completing their survey on May 14, 2019.  CMS Ex. 1; CMS Ex. 4 at 3; CMS Ex. 7 at 2 (Rubina Decl. ¶ 2).  Based on their findings, CMS determined that the facility was not in substantial compliance with:

42 C.F.R. § 483.25 (Tag F684) (quality of care), cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm that is not immediate jeopardy); and
	42 C.F.R. § 483.25(k) (Tag F697) (quality of care:  pain management), also cited at scope and severity level G.CMS Ex. 4 at 3-4.

Following a May 29, 2019 revisit, CMS determined that the facility had returned to substantial compliance.  CMS Ex. 4 at 1-2.

CMS imposed one per-instance CMP of $10,696 for each of the deficiencies cited, for a total penalty of $21,392.  CMS Ex. 4.

Petitioner requested review.

**Page 3**

Petitioner moved for summary judgement, which CMS opposed.  In a ruling dated October 1, 2021, I denied Petitioner’s motion.  Ruling and Order at 1 (October 1, 2021) (e-file #23).

The parties subsequently agreed that this matter may be decided based on the written submissions, without an in-person hearing.  Petitioner Valley House’s Motion at 2 (¶ 5) (Oct. 1, 2021) (e-file #22).1

The parties have filed prehearing briefs (CMS Br., P. Br.) and closing briefs (CMS Cl., P. Cl.).  Petitioner filed a reply brief (P. Reply).

Exhibits

Petitioner objected to nine of CMS’s 17 exhibits (CMS Exs. 1, 4, 6, 7, 8, 9, 11, 12, and 16).  In my October 1 ruling, I determined that the exhibits are relevant and material and overruled Petitioner’s objections.  42 C.F.R. § 498.60(b).

CMS objected to the portions of P. Ex. 1 and to P. Ex. 2.  I determined that CMS’s objections go to the weight of the evidence, not its admissibility, and overruled the objections.

I therefore admitted into evidence CMS Exs. 1-17 and P. Exs. 1-4.  Ruling and Order at 3 (October 1, 2021) (e-file #21).

**Page 4**

Issues

The issues before me are:

1.  Was the facility in substantial compliance with Medicare program requirements, specifically, 42 C.F.R. §§ 483.25 and 483.25(k); and

2.  If the facility was not in substantial compliance, are the penalties imposed ($10,696 per-instance for each deficiency cited) reasonable?

Petitioner also argues that its purported deficiencies caused no actual harm and asks that I reduce the scope-and-severity level.  I may review CMS’s scope-and-severity findings if:  1) a successful challenge would affect the range of the CMP; or 2) 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.  42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10); *Madison Cty. Nursing Home*, DAB No. 2895 at 16 (2018); *NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *Cedar Lake Nursing Home*, DAB 2344 at 9 (2010); *Heritage Park Rehab. & Nursing Ctr*., DAB No. 2231 at 15-16 (2009); *Evergreen Commons*, DAB No. 2175 (2008); *Aase Haugen Homes, Inc.*, DAB No. 2013 (2006).

For a per-instance penalty, the regulations provide only one range (at the time the penalty was imposed, the range was from $2,140 to $21,393), so the level of noncompliance here does not affect the range of the CMP.  42 C.F.R. §§ 408(d), 488.438(a)(2); 45 C.F.R. § 102.3; 84 Fed. Reg. 59549 (Nov. 5, 2019).2

Certain types of deficiencies, including quality-of-care, can lead to a finding of “substandard quality of care.”  The deficiency must be cited at one of the following scope-and-severity levels:  immediate jeopardy; a pattern of or widespread actual harm that is not immediate jeopardy; or widespread deficiencies with the potential for more than minimal harm.  42 C.F.R. § 488.301.  Because the deficiencies here were cited at a lower scope-and-severity level, there has been no finding of substandard quality of care.

Moreover, if I approve a penalty of $10,697 or more, as I do here, CMS’s scope and severity finding will not affect approval of the facility’s nurse aide training program, assuming that it has one.  Under the statute and regulations, the state agency cannot approve the program if CMS imposes a penalty of $10,697 or more.  Thus, even if CMS had found a substandard quality of care, the facility would lose its approval without regard to the scope-and-severity finding.  Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 84 Fed. Reg. 59549, 59559.

**Page 5**

Discussion

**Petitioner’s overarching argument:  surveyor errors**.  Petitioner bases much of its case on alleged errors that the surveyor made, as part of the survey and in her testimony.  Citing a footnote from the Eighth Circuit opinion in *Grace Healthcare of Benton v. U.S. Dept. of Health & Human Servs.*, 603 F.3d 412, 420 n.7 (8th Cir. 2009), Petitioner argues that CMS has the burden of “persuasion and production,” and suggests that, because the surveyor made mistakes, it has not satisfied its burdens.  P. Cl. at 2-3.

I’m assuming that, by “persuasion and production,” Petitioner means that CMS must both come forward with evidence sufficient to establish a prima facie case and then bears the ultimate burden of persuasion.  As the Departmental Appeals Board has repeatedly determined, this is not how the burdens are allocated, and, contrary to Petitioner’s assertion, the Eighth Circuit made no ruling on the Board’s allocation of burdens.  The parties in *Grace Healthcare* did not raise nor argue the issue.  Rather, in a footnote, the court described the Board’s allocation of burdens (discussed below), noted that two circuits have declined to address challenges to that Board’s rule, and cited the Administrative Procedures Act (APA), without commenting on how it applies to provider appeals.  The Court did not mention the Medicare statute, which ultimately governs these proceedings and upon which the Board based its determination as to the relative burdens.

Almost 25 years ago, the Board issued its seminal decision in *Hillman*, which explained how, pursuant to the Medicare statute, the burdens of proof are allotted in provider appeals (there, a rehabilitation agency):  CMS must come forward with evidence sufficient to establish a prima facie case that it had a legally sufficient basis for imposing remedies.  The provider then has the ultimate burden of persuasion.  To prevail, it must prove, by a preponderance of the evidence, that it is in substantial compliance with the relevant statutory and regulatory provisions.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d, Hillman Rehab. Ctr. v. U.S. Dept. of Health & Human Servs.*, No 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).

Later, in *Batavia*, the Board summarized *Hillman’s* rationale, explained why it is consistent with the APA, and applied it to nursing home appeals:

Congress authorized Medicare payments to facilities only if they meet the applicable conditions of participation.  “A mere determination on appeal that it is only ‘as likely’ that the conditions were substantially met as that they were not met could result in payment contrary to statutory intent.”  The purpose of the conditions – to protect the health and safety of facility residents – requires that an affirmative determination of substantial compliance be made.**Page 6**

In deciding who has the burden of proof, it is traditional (and based on fundamental fairness) to consider who has knowledge of the facts involved, which would be the facility.
	Allocating the burden of proof to the facility does not violate the Administrative Procedures Act because the *facility* is the proponent of an order finding it in substantial compliance with Medicare participation requirements.*See Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001).

With respect to Petitioner’s complaints about the quality of the survey, even assuming that there were inadequacies (which I did not find), the regulations are explicit:  inadequate survey performance does not relieve the facility of its obligations to meet all requirements for program participation or invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b); *Avon Nursing Home*, DAB No. 2830 at 11-15 (2017) and cases cited therein (noting that “the Board has consistently held that allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS’s noncompliance and remedy determinations.”).

And, on a related note, Petitioner also complains about purported discrepancies between the contents of the Statement of Deficiencies and the arguments CMS has pursued before this tribunal.  Contrary to Petitioner’s suggestion, there is nothing sacrosanct about that document, and CMS is not limited to its specific allegations.  As the Board has repeatedly explained, the Statement of Deficiencies is a notice document, not intended to “lay out every single detail in support of finding that a violation has been committed.”  *Alden Town Manor Rehab. & HCC*, DAB No. 2054 at 17 (2006) (citing*Pacific Regency Arvin*, DAB No. 1823 at 9-10 (2002)).  So long as the facility knows what it must answer to – which, as here, was accomplished through pre-hearing record development – the facility has sufficient notice.  In its pre-hearing and closing briefs, CMS laid out its positions.  The issues were thus properly raised, and Petitioner has had ample notice and opportunity to respond.3

***1.  After one of its exceptionally compromised residents fell, facility staff did not adequately respond to her complaints of increased pain, did not timely obtain and report her x-ray results, did not administer oxygen as ordered, and did not advise her physician that her oxygen level had dropped.***

**Page 7**

***These failings put the facility out of substantial compliance with 42 C.F.R. §§ 483.25 and 483.25(k).***4

**Program requirements:  42 C.F.R. §§ 483.25 and 483.25(k) (Tags F684 and F697)**.  The statute and the quality-of-care regulation mandate that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2); 42 C.F.R. § 483.25.  To this end, the regulations mandate (among other requirements) that the facility “ensure” that pain management is provided to residents who require such services, consistent with professional standards of practice, the resident’s person-centered care plan, and the resident’s goals and preferences.  42 C.F.R. § 483.25(k).

**Facility policy:  fall prevention**.  The purpose of the facility’s fall prevention policy is “to prevent accidents by providing an environment that is free from hazards over which the facility has control.”  CMS Ex. 10 at 3.  All residents are “to remain as free of accident hazard[s] as possible,” and to receive adequate supervision and assistive devices to prevent accidents.  *Id*.

The policy defines a fall as “unintentionally coming to rest on the ground floor or other lower level” that is not caused by an overwhelming external force, such as a push.  A fall without injury is still a fall.  CMS Ex. 10 at 3.

Under the policy, all residents are considered at risk for falls, and their individual care plans must include interventions to prevent falls.  In addition, each resident’s fall risk must be assessed.  A licensed nurse assesses each resident at the time of admission, quarterly, and when a change of condition assessment is completed.  The nurse must initiate and update the resident’s care plan, as indicated.  After the fall risk is completed, the resident’s interdisciplinary team further assesses the resident’s fall risk factors and, at the care plan meeting, discusses fall prevention interventions.  If indicated, the team updates the care plan in order to minimize the risk of falls.  The team re-evaluates each resident quarterly, annually, or whenever there is a significant change in the resident’s condition.  CMS Ex. 10 at 3.

After a fall, a licensed nurse assesses the resident for injuries and necessary treatment.  The nurse immediately checks to see if the resident is breathing properly and checks the resident’s pulse rate and “volume.”  If a full code resident has stopped breathing, the nurse administers cardiopulmonary resuscitation.  If the resident is bleeding, has skin tears, abrasions, has fainted, etc., the nurse gives proper first aid “according to established

**Page 8**

procedure.”  The nurse looks and palpates for injury and assesses pain, tenderness, swelling, bruising, and range of motion.  CMS Ex. 10 at 4.

The nurse completes neuro checks for all unwitnessed falls and for known head injuries.  The check includes:  the resident’s level of consciousness, orientation, changes in speech and communication, blood pressure, hand grip, dizziness, unsteady balance, and the pupils’ reactions to light.  The nurse *should not move or leave an injured person*.  The nurse should summon help to call a doctor and then carry out the doctor’s order.  If a hip is fractured, or a back or other injury is suspected, staff should make the resident comfortable until the emergency medical unit arrives.  If the resident has no apparent injury, staff should “assist off floor.”  CMS Ex. 10 at 4.

Licensed nurses notify the resident’s attending physician and responsible party and *implement any new orders immediately*.  CMS Ex. 10 at 4.

Licensed nurses must also document, in the nursing progress notes, all falls and document “pertinent information related to the fall [and] the condition of the resident.”  For 72 hours and as needed, licensed nurses from each shift must document ongoing assessments, including neuro checks for unwitnessed falls and falls with a known head injury, and the resident’s response to care and treatment.  CMS Ex. 10 at 4.

Licensed nurses must update the resident’s fall assessment score.  CMS Ex. 10 at 5.

Following a resident’s fall, the interdisciplinary team (including rehabilitation personnel, if appropriate) completes a post-fall assessment.  The assessment includes review of possible causes.  The team must summarize its findings and make recommendations in its progress notes, reviewing and revising the resident’s care plan, as appropriate.  CMS Ex. 10 at 5.

The licensed nurse who witnessed the incident or the nurse who is most familiar with it will complete an incident report and submit it to the Director of Nursing (DON).  The nurse most familiar with the incident will investigate, interviewing staff, residents, and visitors with information.  The goal is to determine the causes of the fall (if possible) and to rule out abuse.  CMS Ex. 10 at 5.

The Quality Assurance and Performance Improvement Committee tracks all falls in the facility, monitors interventions, analyzes trends, develops action plans, and evaluates outcomes.  CMS Ex. 10 at 5.

The resident’s medical record includes all documentation.  CMS Ex. 10 at 5.

**Facility policy:  pain management**.  The articulated purpose of the facility’s pain management policy is to assure that a resident’s pain is accurately accessed and timely

**Page 9**

responded to with pain medication or non-drug interventions, as appropriate.  CMS Ex. 10 at 6.

The policy requires that all residents *be assessed for pain* upon admission, *each time vital signs are monitored*, *when a pain medication is given*, and as indicated.  A licensed nurse teaches the resident/surrogate the facility pain scale.  *Pain medications are given before the pain becomes severe.*  The resident’s *response is documented* on the Medication Administration Record (MAR) *within one hour* of the medication being administered.  CMS Ex. 10 at 6.

Residents who receive pain medications routinely have a *pain scale documented each shift*, indicating the highest level of pain that shift.  A summary of the resident’s pain management is documented in the weekly nursing note.  CMS Ex. 10 at 6.

The policy lists specific procedures that nursing staff must follow:

1.  A licensed nurse assesses each resident for pain during the initial nursing assessment, using the pain scale approved by the facility.

2.  The licensed nurse instructs the resident and/or the resident’s surrogate about the pain scale used by the facility.

3.  The licensed nurse *reviews the resident for pain when vital signs are taken*.  The review includes:  the pain’s origin and severity, alleviating and exacerbating factors, current treatment, and the response to treatment.

4.  For residents on routine pain medication:  during each shift, staff document a pain assessment on the electronic Medication Administration Record (eMAR).  The pain score reflects the highest pain level that occurred on the shift.

5.  Assessment of pain is based on the pain scale.  If the resident cannot verbally indicate the intensity or severity of the pain using the pain scale, the nurse assesses the resident, using the PAINAD tool (assessing behavior as follows:  breathing, negative vocalization, facial expression, body language, and “consolability”).  If the nurse is unable to determine whether the resident’s facial expression is related to pain, the nurse should consider administering pain medication to determine if the resident’s expression changes and appears more comfortable.  If the resident improves with pain medication, the nurse should consider routine administration since the resident cannot request it.

6.  The licensed nurse administers pain medication as ordered and documents the following on eMAR:  the drug; time administered; dose; *pain scale rating*; and, *within one hour, the resident’s response*.

**Page 10**

7.  The resident is assessed to determine if environmental factors are contributing to the resident’s pain.  If so, staff should address the issue.  (The policy lists specific potential issues and possible interventions).

8.  If the pain is new onset, has changed in nature, or *is not relieved with current medication*, staff must *notify the physician* for a review of medications and follow the change of condition policy for contacting the physician.

9.  Update the care plan for pain management with any change in treatment and/or medication.

10.  Notify the family/surrogate decision-maker regarding any new pain medication.

11.  Staff must document, in the weekly summary, kept in the resident’s medical record and in progress notes, the resident’s pain and response to interventions.

12.  Residents experiencing pain, *who are on a pain medication regimen, may require PRN (as needed) pain medication due to breakthrough pain*.  PRN medication may be given if:  the resident is experiencing breakthrough pain; the medication is ordered by a physician; the pain is assessed for frequency, location, and intensity; and a licensed nurse evaluated the effectiveness of the medication.  PRN medication is care planned, administered, and documented in the same way as routine pain medication.

13.  Non-medication pain interventions are attempted and documented prior to administration of PRN medications.

14.  Nonverbal or communication-impaired residents are assessed for behavior, facial expressions, and protective body movements or posture as clues or evidence of pain.

CMS Ex. 10 at 6-8.

Pain assessments and interventions are documented in the resident’s medical record.  CMS Ex. 10 at 8.

**Facility policy:  radiology services**.  The facility has a policy for providing radiology services for its residents.  The policy mandates that radiology services be provided in “an accurate and *timely manner to meet the needs of residents*.”  CMS Ex. 10 at 1 (emphasis added).

To achieve this goal, the policy requires that:

**Page 11**

Orders for radiology tests be noted promptly.  The orders must include the reason for the test and must be submitted to the radiology service;
	Orders be telephoned and/or sent electronically to the radiology service;
	Nursing staff assist radiology technicians with residents, as necessary; and
	The nurse document, in the resident’s medical record, the time the diagnostic test was completed.The radiology service is required to submit the test results to the facility by telephone, computer, or fax.  The nurse then reports the results to the physician, following these guidelines:

If the results are within normal limits, the nurse faxes the results, noting the date and time on the results; the nurse also places the results in the resident’s record.
	*If the results are abnormal, the nurse must telephone or page the physician and fax the results to the physician with the date and time noted.  If the physician does not respond within four hours, the nurse should call or page again*.
	If the results are critical, the nurse should telephone or page the physician and fax the results with the date and time noted.  If the physician does not respond within 20 minutes, the nurse should page again.CMS Ex. 10 at 1-2.

The nurse must document, in the resident’s medical record, the time the radiology results are reported and the physician’s response.  CMS Ex. 10 at 2.

The physician or “licensed independent practitioner” are required to review the radiology results, initial them, and note any new orders on the physician order sheet.  CMS Ex. 10 at 2.

Finally, the resident’s radiology results must be documented in the resident’s medical record.  CMS Ex. 10 at 2.

**Resident 1 (R1)**.  R1 was admitted to the facility on July 28, 2017.  She was then 76 years old, and suffered from a very long list of serious ailments, including sepsis, acute respiratory failure with hypoxia (insufficient oxygen to sustain bodily functions), pneumonia, hypertension, atherosclerosis of the aorta (hardening of the arteries), end stage renal disease, diabetes with diabetic chronic kidney disease, anemia, dementia with

**Page 12**

behavioral disturbance, and an altered mental state.  CMS Ex. 5 at 1-2.  She was prescribed Tylenol (Acetaminophen), 325 mg., two tablets ever four hours, as needed, *for mild pain*.  On a pain scale of 0 to 10, mild pain is rated at 1 to 3.  CMS Ex. 5 at 10;  *see* CMS Ex. 7 at 4 (Rubina Decl. ¶ 8).

R1 required extensive assistance (one-person assist) with transfers, locomotion, dressing, and other activities of daily living.  CMS Ex. 5 at 28; *see* CMS Ex. 5 at 101.  She was assessed at a very high risk of falls, scoring 65 on a scale that considered any score above 45 as high risk.  CMS Ex. 5 at 51-52.

According to an August 31, 2018 physician’s report, R1 frequently fell from her bed or chair.  CMS Ex. 17 at 5.  For example:

On January 11, 2018, she fell and subsequently complained of knee pain, although x-rays showed no fracture;
	She fell from her bed on January 26, 2018, suffering a head injury without any neuro deficit; and
	On August 30, 2018, she fell from her bed when she bent down to pick up her shoes.  She hit her forehead, causing swelling and a hematoma, but did not lose consciousness or experience a change in her vision.CMS Ex. 17 at 1-2, 8.  An August 3, 2018 care plan entry calls for “no further fall episodes.”  To accomplish this goal, the plan lists three general interventions:  anticipate and meet needs; encourage resident to call for assistance; neuro-checks per protocol.  CMS Ex. 5 at 97.5

R1’s hypertension presented serious problems for her.  On February 13, 2018, for example, she became unresponsive and was sent to the emergency room, where her systolic blood pressure measured 180, which is extremely high.  CMS Ex. 17 at 8. Given the fragile state of her heart, it was vitally important that the resident not be subjected to additional stresses.  As discussed below, pain, internal injury, and decreased oxygen levels are factors that can place additional stress on a compromised heart.  CMS Ex. 16 at 3, 5 (Doane Decl. ¶¶ 9, 14).

**Page 13**

**R1’s care plan:  pain management**.  The facility recognized the importance of managing R1’s pain.  From the time of her admission, her care plan set as a goal that she would “voice a level of comfort daily.”  To achieve this, staff were directed to:

Administer her pain medications as ordered;
	*Anticipate the resident’s need for pain relief and respond immediately to any complaint of pain*;
	“*Evaluate the effectiveness of pain intervention* (SPECIFY FREQ).”  Review for compliance, “alleviating of symptoms, dosing schedules and resident satisfaction with results, impact on functional ability and impact on cognition”;
	Monitor/document probable cause of each pain incident and remove/limit causes where possible; monitor/record/report to the nurse any signs or symptoms of non‐verbal pain:  changes in breathing (noisy, deep/shallow, labored, fast/slow); vocalizations (grunting, moans, yelling out, silence); mood/behavior (changes, more irritable, restless, aggressive, squirmy, constant motion); eyes (wide open/narrow slits/shut, glazed, tearing, no focus); face (sad, crying, worried, scared, clenched teeth, grimacing); body (tense, rigid, rocking, curled up, thrashing);
	*Notify physician if interventions are unsuccessful* or if the resident’s current complaint is a *significant change from the resident’s past experience of pain*; and
	Observe and report changes in usual routine, sleep patterns, decrease in functional abilities, decrease in range of motion, withdrawal, or resistance to care.CMS Ex. 5 at 127 (emphasis added).

Following her fall on November 9, the facility added an additional goal to R1’s care plan:  the resident “will remain free of complications related to pelvic fracture, such as contracture formation, embolism[,] and immobility.”  CMS Ex. 5 at 123.  To achieve this, the plan directed staff to:  anticipate and meet the resident’s needs, making sure her call bell is within reach and responding promptly to all requests for assistance; encourage deep breathing and relaxation techniques; *monitor/document pain on a scale of 0 to 10 before and after implementing measures to reduce pain*; monitor/document/report, as needed, signs and symptoms of fracture complications.  Finally, the plan notes that the resident was to be sent to the hospital but that she expired before the transfer could occur.  *Id.*

**Page 14**

**The November 9, 2018 fall**.  At about 10:00 a.m. on November 9, R1 was in the shower room and, while dressing, she fell from a standing position.  According to the report of the investigation, which the facility submitted to the state agency, the fall was assisted.  CMS Ex. 15 at 3-4.  More compelling evidence – particularly the nurse aide’s own description of the incident – establishes that it was not.  The nurse aide, who witnessed the fall, told the surveyors that R1 was sitting in the shower chair.  As the nurse aide was grabbing her wheelchair, R1 stood up by herself and fell.  The nurse aide said that “she could not get to the resident” until after the fall.  CMS Ex. 6 at 4; *see* CMS Ex. 5 at 23-24; CMS Ex. 15 at 1, 3-4.  The facility’s investigation should have included a signed statement from the nurse aide describing the incident.  *See* CMS Ex. 15.  If such a statement exists, it was not part of the investigative report that the facility submitted to the state agency and is not a part of this record.  Further, Petitioner did not present testimony or any written statement from the nurse aide, who was the only witness to the incident (aside from the resident herself) to rebut CMS’s evidence.6

Petitioner objected to the surveyor notes that recount the nurse aide’s statements, characterizing them as inadmissible hearsay.  In overruling the objections, I noted that hearsay is admissible in these proceedings.  42 C.F.R. § 498.60(b).  More important for establishing that this hearsay is reliable:  these statements were made by the facility’s own employee (which may, at least partially, exempt them from the hearsay rule).  *Beatrice State Developmental Ctr.*, DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home*, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence); *See Richardson v. Perales*, 402 U.S. 389, 410 (1971).

**Page 15**

Moreover, R1’s subsequent pain levels and her resulting hemorrhage and hematoma support the finding that the fall was not assisted or, even if assisted, the assistance did not significantly lessen the impact.  She fell hard.  *See* CMS Ex. 5 at 6 (describing “blunt force pelvic injury”).

R1 fell, hitting her buttocks.  She complained of pain in her right hip and low back (tail bone).  Her physician, Maung Tin, M.D., was at the facility and, at about 10:15 a.m., he examined her.  He reported that she experienced pain with movement of the right hip joint, and the sacrum area was tender.  He prescribed Tylenol, as needed, for pain, along with bed rest, and ordered an x-ray of her hips and pelvis to rule out a fracture.  CMS Ex. 5 at 12, 15, 16, 18, 19, 23-25, 92; P. Ex. 4 at 2 (Tin Decl. ¶¶ 3, 6).  Dr. Tin’s written order does not specify the dosage for the Tylenol, although the resident had a standing order for two 325 mg. Tylenol tablets, every four hours, as needed, *for mild pain*.  CMS Ex. 5 at 16; P. Ex. 4 at 2 (Tin Decl. ¶ 6).

**R1’s ongoing, unrelieved pain**.  R1 could not reliably indicate the severity of her pain so the nurses had to do so, based on her behaviors, e.g., her facial grimaces and winces.  CMS Ex. 5 at 74; *see* CMS Ex. 5 at 23, 26; CMS Ex. 10 at 7-8.

The record shows that, during the week prior to her fall, R1 experienced no pain at all.  Nor had she been administered any Tylenol.  CMS Ex. 5 at 74, 82; *see* CMS Ex. 7 at 4 (Rubina Decl. ¶ 8).

Considering that facility policy and R1’s care plan required staff to assess, monitor, and record R1’s level of pain frequently – each time her vital signs were monitored and within one hour of pain medication being administered – the actual documentation of R1’s pain levels is sparse and confusing.  Progress notes and pain assessments are inconsistent.  Pain levels are recorded sporadically, and it is sometimes difficult to determine exactly when the resident experienced that level of pain.  R1’s MAR does not consistently include a record of the highest pain level that occurred on each shift.  CMS Ex. 10 at 6-8.

The resident was placed on 72-hour monitoring.  CMS Ex. 5 at 18, 20.  Between the time of her fall and 8:00 p.m. – at approximately 10:00 a.m., 2:00 p.m., and 6:00 p.m. – staff administered three doses of the previously-ordered Tylenol (2 tablets of 325 mg.).  CMS Ex. 5 at 82; CMS Ex. 7 at 3 (Rubina Decl. ¶ 7); P. Ex. 1 at 3 (Perez Decl. ¶ 6).

With respect to R1’s pain levels, there are discrepancies between the levels contained in the medical records that staff produced at the time of the survey and the levels Petitioner has presented during these proceedings (which Petitioner claims were drawn from R1’s medical records).  The records given to the surveyors do not include pain assessments between 10 and 11 a.m., or between 6 and 7 p.m.  They show documentation of the following pain levels throughout the day:

**Page 16**

When first assessed after her fall (sometime after **10:00 a.m.**), Licensed Vocational Nurse (LVN) Patricia Woodard estimated R1’s pain level at **five** on a scale of one to ten.  The nurse documented this numerical pain level in the incident report, in a “daily skilled documentation” report, and on the MAR.  Pain level 5 indicates moderately strong pain, which cannot be ignored and interferes with activities of daily living.  CMS Ex. 5 at 23, 26, 82; *see* CMS Ex. 10 at 7-8.  Significantly, R1’s order for Tylenol specified that it was for *mild* pain.  It was not intended to combat higher levels of pain.  CMS Ex. 5 at 16.An incident report and the MAR indicate that, when vitals were taken at **2:30 p.m.**, R1’s pain level remained at **five**.  CMS Ex. 5 at 23, 26, 82.  Inconsistently, in the same incident report, LVN Woodard writes “no complaints of pain nor any bleeding noted at the site.”  CMS Ex. 5 at 29.  I find this note baffling.  Petitioner has not explained this apparent inconsistency, and LVN Woodard submitted no testimony.

In documenting the resident’s response to the pain medication administered at 2:00, as required by the facility’s policy (CMS Ex. 10 at 7), the nurse reported “U” for unknown.  CMS Ex. 5 at 82.

Based on the daily skilled documentation reports, Petitioner suggests that staff also assessed R1’s pain level (still level 5) at 3:26 and 3:30 p.m.  I find this doubtful.  The times referred to appear to be the times the reports were prepared, not the times the assessments were made.  As the reports indicate, staff took the resident’s vital signs at 2:30, which was when they were required to assess her level of pain.  In any event, it’s hard to see how accepting those purported assessments changes the outcome here.  In fact, it strengthens CMS’s position that R1’s pain level consistently remained at level 5.
	Contrary to the facility’s policy (CMS Ex. 10 at 6), staff stopped recording numerical pain measurements in the mid-afternoon.  Nevertheless, a health status note, entered at 4:05 p.m., indicates that the resident was medicated for pain management “*with minimal relief noted*.”  CMS Ex. 5 at 18 (emphasis added).
	According to a change in condition report, staff took R1’s vital signs at 5:38 p.m. but, contrary to facility policy, her pain level is not recorded.  However, a narrative description indicates that “*pain in her pelvic area persist[s]*.”  CMS Ex. 5 at 30.R1’s MAR indicates that, during the day shift, staff attempted some non-pharmacological interventions to address the resident’s pain:  a quiet environment, *repositioning*, and rest.  CMS Ex. 5 at 79.  On the other hand, in the change of condition report, LVN Pamela Mamaril, charge nurse for the evening shift, writes that R1 was “*kept in the same position*

**Page 17**

to prevent compromising condition of patient in any way.”  CMS Ex. 5 at 30; *see* CMS Ex. 6 at 11.

The surveyors interviewed the staff who cared for R1 on November 9.  Consistent with the record entries, they told surveyors that R1 endured ongoing pain throughout the day. 
LVN Woodard, the day shift nurse, said that R1’s pain level had been 8/10, but it went down to 6/10.  CMS Ex. 6 at 4.

The nurse aide who cared for R1 on the evening shift told surveyors that she observed the resident about every half hour, and the resident was in pain the entire time.  Her face was “very pale”; she asked for a pain pill; she refused dinner.  The nurse aide called the nurse, who told her that the resident would be sent to the hospital.  CMS Ex. 6 at 8; CMS Ex. 7 at 5 (Rubina Decl. ¶ 10).

LVN Mamaril confirmed that, although the day nurse administered Tylenol at 2:00 p.m., from the beginning of the evening shift (3:00 p.m.), R1 complained of “a lot of pain” in her pelvic area.  She asked to be repositioned, but the nurse declined to do so, not wanting to aggravate the area in case there was a fracture.  Although the resident’s care plan directed staff to notify the resident’s physician if pain-relieving interventions were unsuccessful (CMS Ex. 5 at 127), LVN Mamaril (like LVN Woodard) did not contact R1’s physician regarding the resident’s unrelieved pain.  CMS Ex. 6 at 11; *see* CMS Ex. 7 at 5 (Rubina Decl. ¶ 10).

Thus, the medical records provided to the surveyors, along with statements from nursing staff, confirm that Tylenol did not effectively control R1’s pain, which persisted throughout the day.  Contrary to facility policy and the resident’s care plan, staff did not notify R1’s physician of her unrelenting pain.

Without foundation, Petitioner submitted a chart purportedly showing R1’s pain levels throughout November 9.  P. Ex. 2 at 2.  Responding to CMS’s objections, Petitioner belatedly submitted a supplemental declaration from DON Dana Perez.  DON Perez claims that the chart is part of the facility’s medical records system.  She also identified the nurse who purportedly made the entries, LVN Woodard.  P. Ex. 5 at 2 (Perez Supp. Decl. ¶ 2).

I find multiple problems with the reliability of this evidence.  First, the chart was generated on *November 25, 2019*, more than a year after the incident.  Second, staff did not provide any of this data to the surveyors at the time of the survey, and Petitioner has not explained why.  Third, the data is not wholly consistent with information in the records provided to the surveyors.

Petitioner, however, claims that it did not produce this evidence earlier because it was not aware of what the surveyors reviewed until it received CMS’s prehearing exchange,

**Page 18**

specifically, Surveyor Rubina’s written declaration, CMS Ex. 7; P. Reply at 7.  The problem with this claim is that, in fact, the Statement of Deficiencies lists the documents the surveyors reviewed and specifies that those documents established that R1 suffered pain at level 5 throughout the afternoon of November 9 and unrecorded levels of pain thereafter.  In its response, Petitioner did not challenge those findings, did not claim that any additional pain levels had been recorded, and did not produce any evidence of additional pain levels.  CMS Ex. 1 at 10-12.

But Petitioner’s main problem is that the new data simply does not help its case.  Indeed, if accepted, it paints an even darker picture than that suggested by CMS’s exhibits.

According to the newly-submitted chart:

R1’s pain level at 10:00 a.m. was 5.  This is consistent with the documentation provided to the surveyors.  *See* CMS Ex. 5 at 23, 26, 82.
	At 10:30, R1’s *pain level jumped to 10*.  This dramatic number is not reflected anywhere in R1’s MAR, progress notes, or reports.  But if that number is accurate, it shows that, within half an hour of having been administered Tylenol, R1 experienced *the most severe level of pain possible*.  That staff did not immediately contact her physician, by itself, puts the facility out of substantial compliance with the requirement that it ensure appropriate pain management, 42 C.F.R. § 483.25(k).Further, if R1’s pain reached this level, the staff failed to follow the facility policy that, at the end of each shift, the number be documented in the resident’s medical record and progress notes.  CMS Ex. 10 at 6, 7.

Although she had not been medicated for an hour and a half, the chart next indicates that, by 11:30 a.m., R1’s pain level had dropped to 2.  Again, the records supplied to CMS do not support this claim.  Moreover, that level is inconsistent with the statements that staff, including LVN Woodard, gave to the surveyors.At 2:00 p.m., R1’s pain level was back up to 5.  Although R1’s other records do not show that her pain level was assessed at 2:00 p.m., at least the entry is consistent with the pain levels documented elsewhere.At 2:30 p.m., R1’s pain level was up to 7, which is severe to very severe, disabling pain.  Again, nothing in the records supplied to CMS support this finding.  In fact, those records show that R1’s pain level remained at 5.  CMS Ex. 5 at 23, 26, 82.  Moreover, if accepted, this figure hardly helps Petitioner’s case.  It shows that, half an hour after receiving her pain medication, R1’s pain level increased to a severe level, and no one notified her physician.**Page 19**

Incredibly, according to Petitioner’s chart, one minute later (at 2:31 p.m.), the resident’s pain level dropped to 0, which is no pain at all.  This is inconsistent with the records provided to CMS and staff statements, and I find it not credible.  Unless the resident was given a shot of morphine, it seems highly unlikely that a pain level could drop so dramatically and so suddenly.  And the claim is inconsistent with the nursing note, entered at 4:05 p.m. by LVN Woodard herself, which says that the resident was medicated, as needed, for pain management, “with minimal relief noted.”

P. Ex. 2 at 2; CMS Ex. 5 at 18.

Further, in addition to LVN Woodard, staff were consistent and unwavering in describing R1’s pain.  *See*, e.g., CMS Ex. 6 at 8 (nurse aide confirming that, at 3:00-3:30 p.m., R1 was very pale and in a lot of pain); CMS Ex. 6 at 11 (LVN Mamaril confirming that R1 was complaining of “a lot of pain”); CMS Ex. 7 at 2, 5 (Rubina Decl. ¶¶ 3, 10).  Not one member of the staff has come forward to declare that R1 suffered less than moderate levels of pain (level 5) at any time after her fall.

Thus, the overwhelming evidence establishes that, throughout the day and into the evening of November 9, R1 experienced significant pain, with virtually no relief.  This was plainly foreseeable.  Her Tylenol prescription was meant to address mild pain, not the levels she was experiencing.  Even accepting Petitioner’s questionable assertions that her pain levels dropped so precipitously a couple of times (which I do not) does not establish that the Tylenol sufficiently managed her pain.  Rather, it establishes that her pain levels were inexplicably erratic, which should have been reported to her physician.  The facility was not ensuring that R1 received the level of pain management she required, consistent with professional standards of practice, the facility’s policies, and her own care plan.

Petitioner presents the testimony of a consulting physician, Karen Lynn Josephson, M.D., who opines that the facility acted within the standard of care in treating R1’s pain.  P. Ex. 3 at 8 (Josephson Decl. ¶ 19).7
  However, in reaching this conclusion, Dr. Josephson relies on a misreading of the facts, claiming that R1 responded favorably to the Tylenol – which the evidence shows the resident did not – and disregards both the resident’s care plan and the facility’s policies.

I am not required to accept opinions that do not accurately reflect the underlying evidence.  *See W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 15 (2015); *Guardian Healthcare Ctr.*, DAB No. 1943 at 13 (citing *Shaw by Strain v. Stackhouse*, 920 F.2d

**Page 20**

1135, 1144 (expert affidavits that are conclusory and lacking in specific facts are insufficient to create a genuine factual dispute)).  Nor am I bound to accept Dr. Josephson’s legal conclusions.  *See*, *e.g.*, *Beatrice State Development Ctr*. DAB No. 2311 at 12-14 (affirming that the ALJ decides the legal issues).

The Board has held repeatedly that a facility’s policies “may reflect [its] own judgment about how best to achieve compliance” with participation requirements.  Thus, failing to comply with its own policies supports the finding that the facility was not acting within the standard of care and was not in substantial compliance with sections 483.25 and 483.25(k).  *Heritage House of Marshall Health & Rehab*., DAB No. 3035 at 10-11 (2021) (quoting *Bivins Mem’l Nursing Home*, DAB No. 2771 at 9 (2017)); *Emery County Care & Rehab.*, DAB No. 3006 at 11 (2020) (explaining that CMS may “reasonably rely on the facility’s protocols and treatment policies as evidencing the facility’s own judgment on the care and services that are necessary at a minimum to attain or maintain its residents’ highest practicable physical, mental, and psychosocial well-being”); *Green Valley Healthcare & Rehab. Ctr.*, DAB No. 2947 at 6 (2019) (citing *The Laurels at Forest Glenn*, DAB No. 2182 at 18 (2008)); *Hanover Hills Health Care Ctr.*, DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality of care requirements in section 483.25”); *Life Care Ctr. of Bardstown*, DAB No. 2233 at 21-22 (2009); *see Green Oaks Health & Rehab. Ctr*., DAB No. 2567 at 5 (2014) (holding that the methods a facility chooses to protect its residents are reflected in its policies, assessments, and care plans).  In the absence of contemporaneous documentation justifying their failure to follow facility policy, it is “certainly reasonable” to infer that staff were not aware of it, or that they simply disregarded it.  *Oxford Manor*, DAB No. 2167 at 5-6 (2008).

Thus, without regard to any other shortcomings, the facility’s inadequate response to R1’s ongoing and unrelenting pain puts the facility out of substantial compliance with sections 483.25 and 483.25(k).

**The X-ray**.  As noted above, Dr. Tin ordered that the resident’s hip and pelvis be x-rayed to rule out the possibility of a fracture.  The parties dispute whether he ordered that the x‐rays by taken immediately (“stat”).  DON Dana Perez points out that Dr. Tin’s written x-ray order did not say “stat,” suggesting that the long delay on obtaining the x-ray results was acceptable.  P. Ex. 1 at 2 (Perez Decl. ¶ 4); CMS Ex. 5 at 12.

Although Dr. Tin’s initial handwritten order omits the word “stat,” subsequent entries, including the physician’s handwritten progress notes, call for a “stat x-ray.”  CMS Ex. 5 at 16.  The physician order sent to the radiology service indicates “STAT bilateral hip, pelvic x-ray,” which suggests that nursing staff recognized that Dr. Tin ordered immediate action.  CMS Ex. 5 at 16, 20, 92.  Nurses’ notes twice indicate that the physician ordered “STAT” x-rays.  CMS Ex. 5 at 18.  Subsequent reports confirm that the

**Page 21**

physician ordered STAT x-rays.  *See* CMS Ex. 5 at 19.  The facility also reported to the state agency that the physician ordered “stat x-rays.”  CMS Ex. 15 at 1, 3, 4.

In his written declaration, Dr. Tin limits his testimony to quoting from his initial hand‐written order.  P. Ex. 4 at 2 (Tin Decl. ¶ 3).  He does not deny that he ordered the x‐rays “STAT.”  Nor does he explain why, if he did not intend to require immediate action, both his handwritten progress note and the order sent to radiology services indicate that he did.

Moreover, even if Dr. Tin’s order did not require an immediate response (which I think it did), the facility’s policies did.  The falls policy dictates that, after a resident falls, licensed nurses must “implement any new orders *immediately*.”  CMS Ex. 10 at 4 (emphasis added).  Similarly, the radiology policy provides that a lengthy delay in obtaining and reporting x-ray results is not acceptable.  The policy requires that radiology services be provided “in a timely manner to meet the needs of the residents.”  The tests must be noted promptly, and the time the test is completed must be documented in the resident’s medical record.  If the results are abnormal (as they were here), the nurse must telephone or page the physician and fax the results.  If the physician doesn’t respond within four hours, the nurse should call or page again.  CMS Ex. 10 at 1-2.  The purpose of this four-hour requirement would be defeated if staff could delay up to eight hours before obtaining and reporting the x-ray results.

The facility thus was required to respond promptly.8
  It did not.

There is some dispute regarding how early the radiology service faxed to the facility R1’s x-ray report.  CMS maintains that the document was faxed at 1:14 p.m.  DON Perez, however, maintains that “no evidence” in the medical records shows that the facility received the x-ray reports at 1:14 p.m.  P. Ex. 1 at 7 (Perez Decl. ¶ 17).  This is incorrect. 
On its face, the x-ray report indicates that the radiologist signed it at 1:11 p.m. (CMS Ex. 5 at 22) and that the x-ray service faxed it to the facility at 1:14 p.m.  CMS Ex. 5 at 21 (indicating, at the top and to the right:  “11-09-18 13:14”).  A second fax entry at the top of the report indicates that the service sent it a second time at 4:14 p.m.  *Id*. (top and to the left).  This is consistent with statements from the radiology service representative, who told surveyors that the service faxed the report to the facility at 1:14 p.m. and followed-up at 4:14 p.m.

Without question, facility staff did not timely obtain and report the x-ray results.  Approximately eight hours passed between the time Dr. Tin issued his order and the time

**Page 22**

the facility nurse reported those results to a physician.  In the Change-of-Condition report and nurses’ notes, facility nurses indicate that they received the x-ray results at around 6:00 p.m. and then reported them to the on-call physician.  CMS Ex. 5 at 30, 54, 91; *see* CMS Ex. 5 at 18.

The x-rays showed a “non-acute fracture involving the left pubic ring with healing.”  CMS Ex. 5 at 21.

Petitioner suggests that its delays were of no consequence because, although the results were “abnormal,” they were non-urgent.  P. Cl. at 2.  There are two problems with this position.  First, the physician who eventually reviewed the results considered them significant enough that he ordered R1 transferred to the emergency room.  CMS Ex. 5 at 30, 54, 91.  Second, throughout the day, facility staff had no way of knowing how critical the x-ray results would be.  They were caring for an extremely fragile resident, who had suffered a fall and complained of significant pain throughout the day.  She asked that her position be changed, hoping to alleviate some of the pain.  But, at least during the evening shift, staff declined to do so, fearing that changing positions might further compromise her situation.

Because staff did not timely obtain and report the radiology results to her physician, the facility did not ensure that R1 received care necessary for her to attain or maintain her highest practicable physical, mental, and psychosocial well-being.  Based on this failing, it was not in substantial compliance with section 483.25.

**Oxygen levels**.  During the first eight days of November, R1’s oxygen saturation level consistently measured from 93 to 99%.  CMS Ex. 5 at 73, 76, 77.  According to her physician’s order, if that level fell below 90%, staff were required to administer oxygen at two liters per minute via nasal canula and to notify the physician.  CMS Ex. 5 at 8-9.

The Change-of-Condition report shows that staff took R1’s vital signs at 5:38 p.m. on November 9.  CMS Ex. 5 at 30, 33.  At that time, the resident displayed symptoms of hypoxemia – low oxygen saturation level in the blood – with an oxygen saturation level of 88%.  CMS Ex. 5 at 30; *see* CMS Ex. 16 at 4-5 (Doane Decl. ¶¶ 12, 13).  Disregarding the physician order, staff did not then administer oxygen or consult with the resident’s physician.  *See* CMS Ex. 5 at 30-32).

Petitioner acknowledges that, sometime after 2:30 p.m. but before 8:00 p.m., staff took R1’s oxygen level and, although it measured 88%, they neither administered oxygen nor contacted her physician.  Petitioner characterizes as “speculation” CMS’s finding that this low reading was taken at 5:38 p.m., claiming that the finding is “contradicted by the

**Page 23**

evidence of record.”  P. Br. at 14.  Petitioner cites no actual evidence – and I find none – that contradicts the finding.  Nor does Petitioner suggest when that low reading occurred, if not at 5:38 p.m.  P. Br. at 14.

I agree that the records are not as clear as they should be.9
  However, the only reasonable interpretation of the evidence establishes that staff measured R1’s oxygen level at 5:38 p.m., when they took her other vital signs.

Petitioner incorrectly declares that the narrative portion of the report was written by the morning shift nurse (LVN Woodard).  P. Reply at 11.  Plainly, it was written by LVN Mamaril, who signed it.  CMS Ex. 5 at 32.  The narrative describes, in chronological order, the events that occurred during LVN Mamaril’s late afternoon/evening shift.  First, the morning shift nurse reported (to her) that R1 had fallen.  Thereafter, the following events occurred *on LVN Mamaril’s shift*:

She “[r]eceived [the] resident in bed with [complaints of] pain.”
	The facility had not received the x-ray results.
	Vital signs were taken:  blood pressure 164/70; pulse 76; *88% O2*, with unlabored breathing and no shortness of breath; temperature 97; respirations 18.CMS Ex. 5 at 30.

In the subsequent section of the report, the nurse re-enters those vital signs, and indicates that they were taken at 5:38 p.m.  CMS Ex. 5 at 30.  Although the report also asks for the resident’s most recent O2 stats, the nurse wrote that her O2 level was 97% at 2:30 p.m.  CMS Ex. 5 at 31.  That level was not obtained on LVN Mamaril’s shift; she is obviously referring to a level reported during the earlier shift.  Inasmuch as the LVN was reporting a change in the resident’s condition, it makes some sense:  the report shows that, after 2:30 p.m., R1’s O2 level dropped from 97% to 88%, which is significant.  On the other hand, as CMS maintains, the nurse may simply have neglected to update the reading.  CMS Cl. at 18.  The facility staff who took the reading could obviously have clarified any ambiguity here, but Petitioner did not provide statements from them.

**Page 24**

The narrative also indicates that, after taking R1’s vital signs, staff periodically checked on her, and, 30 minutes after obtaining the 88% level, they retested.  Her O2 level was up to 94%.  The narrative then indicates that staff administered Tylenol at 6:00 p.m. and that the nurse finally received the x-ray results at around 6:00 p.m.  From this, I infer that staff took the follow-up oxygen reading sometime around 6:00 p.m., which would mean that they took the earlier reading sometime around 5:30 p.m.

In any event, no matter when staff discovered that R1’s oxygen saturation level was 88%, they were required to follow her physician’s order:  administer oxygen and notify him of the low reading.  CMS Ex. 5 at 8-9.  They did not do so.  Failing to follow the physician order put the facility out of substantial compliance with section 483.25.  *Cedar Lake Nursing Home*, DAB No. 2390 at 3 (holding that a facility’s failure to comply with physician orders, a resident’s care plan, or its own policies can constitute a deficiency under section 483.25); *Woodland Village Nursing Ctr*., DAB No. 2053 at 9 (2006), *aff’d, Woodland Village Nursing Ctr. v. U.S. Dept. of Health & Human Servs.*, 239 F. App’x 80 (5th Cir. 2007) (citing*Lakeridge Villa Health Care Ctr.*, DAB No. 1988 at 22 (2005), *aff’d, Lakeridge Villa Care Ctr. v. Leavitt*, 202 F. App’x 903 (6th Cir. 2006)).

Citing Dr. Josephson’s declaration, Petitioner argues that staff were not required to follow the physician order as written but could “read into it” a 30-minute delay and that their actions were within the standard of care.  P. Br. at 14-15; P. Ex. 3 at 5 (Josephson Decl. ¶ 13).  Significantly, Dr. Tin does not echo this opinion.  P. Ex. 4.

The physician order is unambiguous.  Staff were not free to ignore it or to alter it.  The standard of care mandates that staff follow physician orders.  CMS Ex. 7 at 7 (Rubina Decl. ¶ 20); CMS Ex. 16 at 4 (Doane Decl. ¶ 11).  If, for some reason, staff disagree with an order, they are obligated to contact the physician and ask that he modify it, which they did not do.  CMS Ex. 7 at 8 (Rubina Decl. ¶ 21).

Moreover, notwithstanding what might have been acceptable for others, Dr. Tin’s order made sense for R1.  She was exceptionally fragile, and low oxygen levels put increased stress on her already-compromised heart.  As CMS’s medical consultant, Dr. Marcus Doane, explained, the body typically responds to hypoxemia by making the heart work harder to deliver enough oxygen to the body by pumping more blood.  This typically increases blood pressure, exacerbating hypertension.  The heart rate increases.  The additional workload on the heart “in a setting of structural heart disease[,] combined with meager oxygen delivery to the heart because of hypoxemia and anemia[,] increases the risk of arrhythmias for people like” R1.  Supplemental oxygen makes it easier for the heart to meet the body’s demands for oxygen.  The supplemental oxygen allows the lungs to increase the concentration of oxygen in the blood, which spares the heart the extra work of providing adequate oxygen to the body.  CMS Ex. 16 at 5 (Doane Decl. ¶ 13).

**Page 25**

By withholding oxygen by nasal cannula from [R1] when her oxygen saturation rate fell below 90%, [the facility] failed to follow the physician’s order and placed additional burdens on [R1’s] heart by requiring it to pump harder in order to deliver an increased volume to meet the body’s oxygen demands.

Providing supplemental oxygen whenever her O2 levels dropped would have spared her heart the additional work. CMS Ex. 16 at 4-5 (Doane Decl. ¶¶ 13, 14).10

**The crisis**.  The nurses’ notes relate that, at 8:00 p.m., the nurse aide and the resident were calling for help.  The resident complained of shortness of breath.  Her oxygen saturation level was again at 88%.  Consistent with physician orders, the nurse applied oxygen via a nasal cannula.  The notes describe the resident as responsive but nauseated, although she did not vomit.  Although she appeared to be breathing, the nurse could not palpate a pulse.  Staff called 911 and, when the emergency personnel arrived, they pronounced R1 dead at 8:28 p.m.  CMS Ex. 5 at 18, 32, 54.

An autopsy found “a 4 X 3 inch dark, purple-red hematoma along the length of and throughout the left psoas major muscle.”  CMS Ex. 5 at 40.

R1 died of hypertensive atherosclerotic cardiovascular disease complicated by blunt force pelvic injury.  CMS Ex. 5 at 6, 44.  Dr. Doane explains how the medical examiner reached his conclusion:

Blunt force pelvic injury can complicate heart disease because blunt force injury can cause pain and internal injury.  Pain and internal injury are likely to put additional stress on the cardiovascular system, because the body will often respond to pain by increasing the heart rate, blood pressure, or both.  Here, [R1’s] cardiovascular system was already compromised, as reflected in the autopsy findings demonstrating hypertensive and atherosclerotic cardiovascular disease [citation omitted].  Placing additional stress on a compromised heart can lead to a fatal arrhythmia (faulty heart beat).

CMS Ex. 16 at 3 (Doane Decl. ¶ 9).

**Page 26**

***2.  The penalties imposed are reasonable.***

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

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Ctr.*, DAB No. 1848, at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9; *CarePlex of Silver Spring*, DAB No. 1683 at 8 (1999).

The burden is on the facility “to demonstrate, through argument and submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 22 (2017) (quoting *Oaks of Mid City Nursing and Rehab. Ctr.*, DAB No. 2375 at 26-27 (2011)).

Here, CMS imposes per-instance penalties of $10,696 for each of the two deficiencies cited. These are in the lower-middle range for per-instance penalties ($2,140 to $21,393).  42 C.F.R. §§ 488.408(d), 488.438(a)(2).

With respect to the section 488.438(f) factors, I note first that the facility has a less than stellar history.  The facility was not in substantial compliance for any of the surveys conducted between May 2015 and May 2019.  For the survey ending June 15, 2018, it had multiple life-safety and health deficiencies, including a deficiency cited under section 483.25 (Tag F684) – quality of care.  During its May 2017 survey, it also had multiple deficiencies, and two of them were cited at scope-and-severity level G.  CMS Ex. 3.  The facility’s history thus justifies increasing the penalties above the minimum.

Petitioner does not claim that its financial condition affects its ability to pay these penalties.

Applying the remaining factors, facility staff allowed one of its residents to spend almost an entire day in continuous pain.  It was evident that the medication prescribed to treat mild pain did not alleviate what she was experiencing.  That she suffered ongoing,

**Page 27**

unrelieved pain is (contrary to Petitioner’s claims) actual harm, regardless of whether it hastened her death.  Yet staff did not contact her physician, showing a disregard for the resident’s care, comfort, or safety, for which the facility is culpable.  Such culpability justifies the $10,696 penalty imposed for failing to ensure appropriate pain management.

In addition to its shortcomings in pain management, staff’s long delay in obtaining and reporting the results of R1’s x-ray and its failing to follow the physician order when R1’s oxygen saturation levels fell below normal levels also shows an indifference or disregard for the resident’s care, comfort, or safety, for which the facility is culpable.  Staff’s inaction justifies the $10,696 penalty for failing to ensure that the resident receive, and that it provide, the necessary care and services to allow her to attain or maintain her highest practicable physical, mental, and psychosocial well-being.

For these reasons, I find that the penalties imposed are reasonable.

Conclusion

The facility was not in substantial compliance with Medicare program requirements governing quality of care and pain management, 42 C.F.R. §§ 483.25 and 483.25(k).  The penalties imposed – $10, 696 per instance for each deficiency cited – are reasonable.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1.  Complaining about the time this matter has been pending before the Civil Remedies Division, Petitioner asked the Departmental Appeals Board to remove it pursuant to 42 C.F.R. § 498.76.  Petitioner’s Motion to Remove Hearing to Departmental Appeals Board (Sept. 6, 2021) (e-file #19).  According to Petitioner, delays cause the facility “significant collateral prejudice,” which will be exacerbated if the matter is not resolved before the end of February 2022.  Id. at 6 (¶ 10).  I explained to Petitioner that a party in need of an expedited hearing would ordinarily file a motion to expedite and demonstrate that its position differs from that of others who are waiting to have their appeals resolved. (Petitioner filed no such motion.)  I also explained that, although Petitioner’s appeal was next in the queue, given the realities of the hearing process (scheduling, transcript, closing briefs), I could not commit to resolving it by the end of February.  However, I would be able to review and decide the case on the written record prior to the end of February.  By Direction of Letters (Sept. 17, 2021) (e-file #20, #20a).  The parties then agreed that I should decide the case based on the written record.  Petitioner’s Motion at 2 ¶ 5 (Oct. 1, 2021) (e-file #22); P. Cl. at 6.  back to note 1
                      2.   Penalties are inflation-adjusted and change annually (more or less).  The amount is determined as of the date the penalty is assessed, in this case, on May 22, 2019.  CMS Ex. 4; see 84 Fed. Reg. 59549.   back to note 2
                      3.  Moreover, although I decline to do so, I have the authority, on my own motion, to add new issues.  42 C.F.R. § 498.56(a); Jennifer Matthew Nursing & Rehab., DAB No. 2192 at 49-50 (2008). back to note 3
                      4.   My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. back to note 4
                      5.   Notwithstanding this worrisome number of falls, and autopsy findings of abrasions and contusions (unrelated to the November 9 fall), CMS has not cited the facility for failing to prevent accidents under 42 C.F.R. § 483.25(d).  See CMS Ex. 5 at 40, 44 (noting “clinical history of falls”).  I therefore do not consider whether the facility failed to ensure that R1’s environment was as free of accident hazards as possible and whether she received adequate supervision and assistance devices to prevent accidents.  back to note 5
                      6.   It seems that the incident report may have been inaccurate in other respects.  According to the report, the nurse aide remained with the resident, calling out for assistance.  CMS Ex. 15 at 3-4.  But the surveyors, with the facility’s DON, reviewed video surveillance taken outside the shower room on November 9, 2018.  The video showed R1 and the nurse aide enter the shower room at about 10:00 a.m.  At 10:10 a.m., the nurse aide left the shower room without the resident.  At 10:11 a.m., she returned to the shower room, followed by another nurse aide.  At 10:15 a.m., the first nurse aide emerged from the shower room, wheeling the resident out and back to her room. A licensed vocational nurse (LVN) and the resident’s physician joined them.  CMS Ex. 1 at 3-4; CMS Ex. 6 at 4 (nurse aide confirming that, when no one responded to the call light and her cries, she left the shower room to get help).  Neither the DON nor the LVN disputes any of this.  See P. Ex. 1 (Perez Decl.); CMS Ex. 6 at 3 (LVN Woodard confirming that she was one room away from the shower room when the nurse aide approached her); CMS Ex. 6 at 5 (second nurse aide confirming that R1 was alone in the shower room when she entered).  CMS has not pursued this issue, however.  back to note 6
                      7.  Dr. Josephson owns her own medical practice.  She is a graduate of State University of New York and has a medical degree from Case Western Reserve.  She specializes in geriatric medicine.  P. Ex. 3 at 1 (Josephson Decl. ¶ 1), 10-19. back to note 7
                      8.   The facility’s Assistant DON agreed.  She told the surveyors that staff should have followed up if they didn’t receive the x-ray results within four hours.  She reviewed the resident’s medical records and found no documentation that the nurses followed up with the radiology service.  CMS Ex. 6 at 17; CMS Ex. 7 at 11 (Rubina Decl. ¶ 30). back to note 8
                      9.  The facility should not benefit from the inadequacies of its own record-keeping.  Medical records must be kept in accordance with accepted professional standards; they must be complete and accurately documented.  42 C.F.R. § 483.70(i)(1); see Putnam Ctr., DAB No. 2850 at 20 (2018) (emphasizing the importance of complete and accurate clinical records).  back to note 9
                      10.  Since 2008, Dr. Doane has been consulting with the state agency on health care facilities’ compliance with regulatory requirements (among other issues).  He is a graduate of Stanford Medical School and holds a Master’s in Public Health from the University of California – Berkeley.  CMS Ex. 16 at 2 (Doane Decl. ¶¶ 1, 2), 6-7. back to note 10 Back to top
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