Magnolia Holdings, LLC DBA Oak River Rehab, CR6283 (2023)

DECISION

Petitioner, Magnolia Holdings, LLC DBA Oak River Rehab, is a long-term care facility located in Anderson, California, that participates in the Medicare program.  One of its residents was badly burned while smoking, unsupervised and unprotected, and his injuries proved fatal.  The Centers for Medicare & Medicaid Services (CMS) subsequently determined that the facility was not in substantial compliance with the Medicare program requirement governing accident prevention (42 C.F.R. § 483.25(d)) and imposed a per-instance civil money penalty (CMP) of $20,780. 

Petitioner appealed. 

For the reasons set forth below, I find that the facility was not in substantial compliance with 42 C.F.R. § 483.25(d) and that the penalty imposed is 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

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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 conduct periodic surveys to determine whether skilled nursing facilities 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.  Facilities 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). 

In this case, on February 25, 2021, the facility reported that one of its residents had been smoking unsupervised, set himself on fire, and suffered third degree burns over 50% of his body.  CMS Ex. 1 at 1, 3-4.  Surveyors from the California Department of Public Health (state agency) went to the facility and completed a complaint investigation on April 8, 2021.  CMS Ex. 24, CMS Ex. 31 at 2 (Smith Decl. ¶ 4); CMS Ex. 32 at 2 (Dyer Decl. ¶ 4).  Based on their findings, CMS determined that the facility was not in substantial compliance with one Medicare participation requirement:  42 C.F.R. § 483.25(d) (Tag F689 – quality of care:  accident prevention) cited at scope-and-severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety).  CMS Exs. 24, 29.¹   

Following a May 24, 2021 revisit survey, CMS determined that the facility returned to substantial compliance that day.  CMS Ex. 25, CMS Ex. 29 at 2.  CMS has imposed against the facility a per-instance CMP of $20,780.  CMS Ex. 29 at 2. 

Petitioner appeals. 

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Decision on the written record.  In my standing order, I explained that a hearing to cross-examine witnesses would be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine.  Standing Order at 5.  CMS listed three witnesses and provided their written direct testimony.  Petitioner listed no witnesses.  Although Petitioner initially asked to cross-examine all three of CMS’s witnesses, it subsequently withdrew its request.  Order Summarizing Pre-hearing Conference and Setting Closing Brief Schedule at 3-4 (January 26, 2023).  Because there are no witnesses to be examined or cross-examined, an in-person hearing would serve no purpose, and the case may be decided based on the written record.  Order Setting Closing Brief Schedule at 4.²   

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

Exhibits.  With its brief, CMS submitted 39 exhibits (CMS Exs. 1-39).  Petitioner submitted no exhibits.  In the absence of any objections, I admitted into evidence CMS Exs. 1-39.  Order at 3. 

Issues

The issues before me are: 

• Was the facility in substantial compliance with 42 C.F.R. § 483.25(d); and
• If the facility was not in substantial compliance, is the penalty imposed – $20,780 per-instance – reasonable. 

Except to argue that it was in substantial compliance, Petitioner has not challenged the scope-and-severity finding (immediate jeopardy).  In any event, I may review CMS’s scope-and-severity finding 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

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(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, so the level of noncompliance here does not affect the range of the CMP.  42 C.F.R. § 488.438(a)(2).³   

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.  The deficiency here was cited at the immediate jeopardy level, and CMS found substandard quality of care, which might suggest that the scope-and-severity level is reviewable. 

However, if (as here) I approve a penalty of $11,160 or more, 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 $11,160 or more.  Thus, the facility loses its approval without regard to the scope-and-severity finding.  Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 85 Fed. Reg. 2,869, 2,886.  The immediate jeopardy determination is therefore not reviewable. 

Discussion

1. The facility was not in substantial compliance with 42 C.F.R. § 483.25(d) because it did not properly supervise residents who could not safely smoke unsupervised.⁴ 

Program requirement:  42 C.F.R. § 483.25(d) (Tag F689).  The statute mandates 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).  To this end, the “quality of care”

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regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistive devices to prevent accidents.  42 C.F.R. § 483.25(d). 

The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10, aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 Fr. App’x. 900 (6th Cir. 2005); accord, Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistive devices designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”).  A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  Briarwood at 5; Windsor Health Care Ctr., DAB No. 1902, at 5 (2003), aff’d, Windsor Health Care Ctr. v. Leavitt, No. 04-3018 (6th Cir. 2005);42 C.F.R. § 483.25(d).⁵    The issue is not whether the facility took “some steps” to mitigate an assessed risk; the issue is whether the facility took “all reasonable steps.”  Logan Healthcare Leasing LLC d/b/a Logan Care and Rehab, DAB No. 3036 at 15 (2021) (emphasis in original). 

a.  The situation prior to March 3, 2021. 

1)  The facility’s smoking policy.  The record includes two smoking policies, both indicating that they were revised in April 2012.  CMS Ex. 16.⁶    However, the more restrictive policy (requiring supervision and smoking aprons for all smoking residents) was further revised on March 3, 2021, shortly after R1 had burned himself so badly.  CMS Ex. 16 at 1-4.  Although Petitioner has not commented on either of the policies, I infer that facility staff revised the smoking policy in response to the accident. 

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The earlier smoking policy, in effect at the time of the accident, described its purpose as:  to “establish and maintain safe resident smoking practices.”  CMS Ex. 16 at 3.  Among other provisions, the policy provided that: 

• staff would consult the resident’s attending physician and Director of Nursing (DON) to determine any restrictions on a resident’s smoking privileges;
• any smoking-related privileges, restrictions, and concerns would be noted on the resident’s care plan, and all personnel would be alerted to those issues;
• the facility could impose smoking restrictions on residents at any time if the resident could not smoke safely with the available levels of support and supervision;
• while smoking, any resident with restricted smoking privileges must be supervised directly by a staff member;
• staff will review, periodically, the status of a resident’s smoking privileges and consult, as needed, the attending physician and DON. 

CMS Ex. 16 at 6. 

The policy includes instructions for “smoking articles” for residents with independent smoking privileges: 

• residents with independent smoking privileges must keep cigarettes, pipes, tobacco, or other smoking articles at the nurse’s station unless otherwise determined by the interdisciplinary team;
• residents may not have or keep lighters, matches, or lighter fluids in their personal possession at any time;
• residents with independent smoking privileges may not give smoking articles to residents with restricted smoking privileges (anyone observing this must immediately report it to the on-duty charge nurse);
• smoking is restricted to the designated smoking patio;
• the resident will be educated and encouraged to use a smokers apron; if the resident declines its use, a “risk vs benefits” must be signed acknowledging the associated risks up to and including major injury and or death. 

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CMS Ex. 16 at 6. 

A separate list includes instructions for residents without independent smoking privileges: 

• residents without independent smoking privileges must keep cigarettes, pipes, tobacco, or other smoking articles at the nurse’s station unless otherwise determined by the interdisciplinary team;
• residents may not have or keep lighters, matches, or lighter fluids in their personal possession at any time;
• residents without independent smoking privileges may not give smoking articles to other residents (anyone observing this must immediately report it to the on-duty charge nurse);
• smoking is restricted to the designated smoking patio under direct supervision;
• anyone who supervises smoking residents must be advised of any restrictions/concerns and the residents’ plans of care related to smoking;
• the resident will be educated and encouraged to use a smokers apron; if the resident declines its use, a “risk vs benefits” must be signed acknowledging the associated risks up to and including major injury and or death. 

CMS Ex. 16 at 7. 

Finally, the policy restricts staff members from purchasing and/or providing to residents any smoking articles unless approved by the charge nurse.  Id. 

Allowing a resident to smoke unsupervised was no small matter.  The smoking patio was outside the facility.  Although a video camera surveilled the area, staff were not always aware of when residents went out to smoke, and no staff member was assigned to watch the video monitors.  Staff would become aware of a problem only when someone happened to look at the monitor; there were no guarantees that anyone would observe an emergency when it occurred.  Even then, a staff member who observed a problem over the monitor would have to exit the building to get to the smokers and could not quickly assist someone who had an accident.  CMS Ex. 31 at 8-9 (Smith Decl. ¶ 24); CMS Ex. 32 at 4-5 (Dyer Decl. ¶ 12). 

Further, as CMS points out, the dangers posed by unsupervised smoking are not limited to the smokers themselves.  The facility has a duty to protect other residents from the

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danger of fires that an unsupervised smoker may cause.  CMS Br. at 14; CMS Ex. 31 at 9 (Smith Decl. ¶ 26); see Logan Healthcare, DAB No. 3036 at 9.⁷   

2)  Resident 1 (R1).  R1 was a 90-year-old man, admitted to the facility on May 30, 2020, suffering from a long list of impairments, including chronic obstructive pulmonary disease with acute exacerbation, and acute respiratory failure.  At the time of admission, he required supplemental oxygen.  He also had a history of pneumonitis due to inhaling food and vomit. 

R1 suffered from generalized osteoarthritis, restless leg syndrome, and generalized muscle weakness.  He had multiple rib fractures.  He had difficulty walking.  He had a history of falling and of syncope (short-term loss of consciousness) and collapse.  He had an artificial knee joint and an artificial hip joint.  He was nicotine dependent.  He had been using an opioid analgesic long term.  CMS Ex. 12 at 1, 54-55; CMS Ex. 14 at 65. 

R1 used a wheelchair for locomotion, and an assessment described him as “totally unstable to ambulate without assistance.”  CMS Ex. 15 at 88.  He was considered a fall risk because of his intermittent confusion and because he was administered narcotics.  CMS Ex. 15 at 88. 

He had unspecified dementia without behavioral disturbance.  He was incapable of understanding his rights and responsibilities and could not give informed consent.  CMS Ex. 14 at 75; CMS Ex. 20 at 1.  His granddaughter was responsible for his healthcare decisions.  CMS Ex. 12 at 6; CMS Ex. 34 at 1 (Cotten Decl. ¶ 1).  Occupational therapy treatment notes describe, as “barriers impacting treatment,” his decreased attention to task, impulsivity, and severe cognitive impairment.  CMS Ex. 15 at 56. 

3)  The incident.  Notwithstanding his dementia and significant physical problems – and without the consent of R1’s responsible party – the facility determined that R1 could smoke safely without supervision (discussed below).  On the morning of February 25, 2021, he went alone to the facility’s designated smoking area.  While attempting to light his pipe, he struck a match but “lost control.”  The match fell into his lap and set his clothing on fire.  He could not pat out the fire.  CMS Ex. 15 at 67; CMS Ex. 20 at 2. 

There were no witnesses. 

The nurse aide who first noticed R1’s distress confirmed that no one was supervising him.  She told Surveyor James Smith, R.N., that she had been sitting at the nursing

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station, waiting for the breakfast cart, when she saw on the surveillance monitor that R1 “had a bright orange flare up his chest area.”  CMS Ex. 31 at 5 (Smith Decl. ¶ 14).⁸   Neither the nurse aide nor anyone else denies that she made the statement nor that the statement was true. 

When statements are made by the facility’s own employees, and those individuals have not refuted them, they may constitute substantial evidence.  See 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). 

According to a nurse’s note, at about 8:10 a.m., the nurse aide alerted her that a resident was on fire in the smoking area.  The nurse grabbed a fire extinguisher, ran to the smoking area, and put out the fire.  CMS Ex. 12 at 64.  Staff called 911 and the emergency medical responders took R1 to the hospital.  CMS Ex. 12 at 64. 

4)  The outcome.  When the paramedics arrived at the facility, R1 was still “smoldering.”  CMS Ex. 15 at 67.  He had partial to full thickness burns over 50 to 60% of his body.  He was administered Fentanyl for pain, which was switched to Dilaudid.  CMS Ex. 15 at 68.  He was admitted to the hospital’s trauma unit for comfort measures, in accordance with his advanced directive.  He was administered morphine and Ativan.  He died at 4:00 a.m. the following morning.  CMS Ex. 15 at 69, 87. 

R1’s death certificate confirms that he had burns over 50 to 60% of his body and notes the cause:  he dropped a lit match on his lap while smoking.  CMS Ex. 28.  

5)  The facility’s flawed defenses.  Initially, administrative staff told surveyors that supervising smokers violated the residents’ rights.  The facility’s DON told surveyor Smith “we can’t have ongoing supervision of them.  It restricts their ability to smoke at will and infringes on their patient rights.”  CMS Ex. 31 at 6 (Smith Decl. ¶ 19).  This position was contrary to the facility’s policy, described above, which explicitly authorized imposing smoking restrictions on residents “at any time the resident could not smoke safely with the available levels of support and supervision.”  CMS Ex. 16 at 6.

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It is particularly hard to credit the DON’s defense given that, during the COVID pandemic, the facility did not allow any residents to smoke.  CMS Ex. 31 at 8 (Smith Decl. ¶ 23).  

Moreover, it seems that the facility may have been motivated by staffing concerns rather than resident rights.  Nurse Aide 2 told Surveyor Dyer that, when the facility had more staff and more smokers, they used to supervise all smoking residents.  CMS Ex. 32 at 4 (Dyer Decl. ¶ 12).  No doubt, allowing unsupervised smoking uses up fewer staff resources, but that does not justify compromising resident safety.  CMS Ex. 31 at 8 (Smith Decl. ¶ 23). 

In any event, Petitioner seems to have abandoned that position.  It now justifies its allowing R1 to smoke without supervision by pointing to a January 18, 2021 smoking assessment.  P. Br. at 3.  According to the assessment, on January 14, 2021, the assistant director of nursing (ADON) observed R1’s smoking.  The resident demonstrated that he could pack tobacco into his pipe, lighting, smoking, and extinguishing without incident.  The ADON wrote that R1 agreed to abide by smoking policies (but see CMS Ex. 13 at 2, which suggests that he did not).  He declined to wear a smoking apron, “stating that he has been smoking for over 50 years and does not need one.”  According to the ADON, R1’s granddaughter (and responsible party) gave “verbal consent” to waive the smoking apron, and both R1 and his granddaughter understood the risks of burns and injuries.⁹   

Notwithstanding the policy requiring signed consent for waiving the smokers apron, the facility did not secure the responsible party’s signature.  Because the resident “preferred” to keep his pipes on him, as they had sentimental value, the facility apparently allowed it.  CMS Ex. 7 at 4, 8-10; CMS Ex. 13 at 1-3; see CMS Ex. 7 at 156; CMS Ex. 16 at 6.¹⁰   

Although the resident rejected the smokers apron, no evidence suggests that the facility offered any additional safety measures.

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Petitioner also points to one grossly inaccurate section of a February 10, 2021 MDS (Minimum Data Set) assessment to justify allowing R1 to smoke unsupervised.  P. Br. at 3; P. Cl. Br. at 3.  Although most of the assessment is left blank (see CMS Ex. 7 at 42-48), one section indicates that R1 had full range of motion in all of his upper and lower extremities.  CMS Ex. 7 at 41.  The facility’s MDS coordinator, who was a licensed vocational nurse, signed off on this section of the assessment.  CMS Ex. 7 at 74.  She was not a witness in these proceedings, and Petitioner has not explained how she reached her conclusions, which are otherwise unsupported and are flatly contradicted by R1’s other assessments, the nursing notes, and statements from his granddaughter and from staff who cared for him.  See discussion below. 

Nothing in the smoking assessment (or elsewhere in the record) suggests that the facility consulted R1’s physician regarding restricting his smoking privileges, as required by the facility’s policy.  CMS Ex. 7 at 8-10; see CMS Ex. 16 at 6.  Nothing suggests that the facility’s occupational therapist was consulted either, although she was in the best position to assess the resident’s manual dexterity.  See CMS Ex. 31 at 6 (Smith Decl. ¶ 18).  The occupational therapist was not part of the resident’s interdisciplinary team that made the decision on smoking.  CMS Ex. 13 at 2. 

I do not consider one observation sufficient to justify allowing a demented and severely physically impaired resident to smoke without supervision.  As discussed below, in determining that R1 did not require supervision, facility staff overlooked multiple compelling reasons why he did require supervision:  his cognition was severely impaired; his fine and gross motor skills were significantly impaired; and he took multiple medications, including opioids, that made his unsupervised smoking unsafe.  Finally, he was not capable of giving informed consent, and his responsible party did not consent to his smoking unsupervised.  CMS Ex. 12 at 6; CMS Ex. 14 at 75; CMS Ex. 34 at 1 (Cotten Decl. ¶ 1). 

6)  Significantly impaired cognition.  At the time he was admitted to the facility, R1 showed signs of cognitive impairment and was diagnosed with dementia.  CMS Ex. 12 at 1, 54-55; CMS Ex. 14 at 65; CMS Ex. 34 at 2 (Cotten Decl. ¶ 1). 

A February 2, 2020 assessment found that R1 had a BIMS (Brief Interview of Mental Status) score of 3, which means his cognition was severely impaired.  CMS Ex. 15 at 97.  One year later, on February 10, 2021, his BIMS score was again 3.  He did not know the month, year, or day of the week; he could not recall any words after a few minutes.  CMS Ex. 14 at 3; CMS Ex. 15 at 99-101. 

The facility’s social services assistant confirmed that R1 was confused at times because of his dementia.  CMS Ex. 31 at 5 (Smith Decl. ¶ 16). 

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Individuals with dementia are at an increased risk of hospitalization for a burn compared to people without dementia.  CMS Ex. 32 at 3 (Dyer Decl. ¶ 7); CMS Ex. 35 at 8.  The Alzheimer’s Association warns that people with dementia should not smoke when they are alone.  The symptoms of dementia, such as forgetfulness and poor judgment, make it very risky for them to smoke unsupervised.  Among other recommendations, the Association advises that someone “make sure [smokers] don’t drop hot ashes on their clothes or chair.”  CMS Ex. 38 at 2. 

Instructions from the Mayo Clinic echo this advice.  “If the person with dementia smokes, always supervise smoking.”  CMS Ex. 39 at 2.  

7)  Fine and gross motor skills – manual dexterity.  R1’s granddaughter confirmed that R1 “had dexterity issues in his hands due to his former career as a farrier” (one who cares for horses’ hooves, including trimming and shoeing them) and that the arthritis in his hands was getting progressively worse.  CMS Ex. 34 at 2 (Cotten Decl. ¶ 1).  The objective medical evidence and the observation and opinion of R1’s occupational therapist confirm the granddaughter’s observations. 

Because an occupational therapist specializes in assessing fine motor skills, R1’s OT assessments and treatment notes are particularly revealing.  Records of R1’s occupational therapy demonstrate that his manual dexterity was significantly impaired: 

• June 9, 2020 treatment records describe R1’s decreased fine and gross motor skills in both hands.  The OT ordered a two-handled sippy cup.  CMS Ex. 15 at 52.  A both-hand sippy cup has two handles so the user can grasp it with both hands.  That R1 required it shows that he had dexterity issues with both hands.  CMS Ex. 31 at 4 (Smith Decl. ¶ 10); see CMS Ex. 22 at 5-6 (explaining that two-handled cups are given to a resident “because of shakiness or unsteadiness of hands.”). 

• June 22, 2020 treatment notes describe “poorly coordinated finger manipulations.”  CMS Ex. 15 at 49. 

• June 26, 2020 OT treatment notes describe R1’s upper extremities and hands as “poorly coordinated,” and indicate that he had limited function “for manipulation of clothing and utensils” and even self-feeding.  Because of the rigidity in his hands, R1 was unable to manage simple maneuvers.  CMS Ex. 12 at 36. 

• A month later, in treatment notes dated July 22, 2020, the occupational therapist reported R1’s decrease in gross and fine motor skills for simple tasks, such as setting up his toothbrush for oral care and putting in his hearing aids.  CMS Ex. 12 at 47. 

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• Notes dated February 19, 2021, again describe R1’s poor safety awareness and repeat that he was unable to use a regular cup but required a “B (both) hand sippy cup” with a lid.  CMS Ex. 12 at 66. 

The facility’s occupational therapist told Surveyor Smith that R1 had coordination issues.  He had shod horses his whole life, so his hands were stiff.  He couldn’t manipulate things well, which would “definitely have been a factor in [his] accident.”  His pipe was small.  “I don’t know how they deemed him OK to smoke.”  She noted that someone “probably” noticed that he was having trouble with his hands, which were big and stiff.  CMS Ex. 31 at 6 (Smith Decl. ¶ 18).  Petitioner has not denied that the occupational therapist made these statements.  See Beatrice State, DAB No. 2311 at 17, 18; Omni Manor, DAB No. 1920 at 11.  

R1’s granddaughter also testified that, as a practical matter, the resident was not able to turn the wheel in his cigarette lighter because of the arthritis in his hands.  CMS Ex. 34 at 2 (Cotten Decl. ¶ 1).  Nurse Aide 2 confirmed this; he told Surveyor Smith that R1 could not light his pipe using an electronic lighter, “so we provided him with matches.”  CMS Ex. 31 at 5 (Smith Decl. ¶ 15).  Petitioner has not explained how or why the facility determined that a resident who could not manipulate a lighter could safely handle matches. 

Significant as these limitations were, R1’s problems went beyond the issues he had with his hands.  He was a fall risk.  CMS Ex. 34 at 2 (Cotten Decl. ¶ 1).  He was not safe by himself.  CMS Ex. 34 at 2 (Cotten Decl.).  He had poor safety awareness.  CMS Ex. 12 at 66.  Nurse Aide 2 told Surveyor Julee Dyer, R.N., that R1’s hands and knees were stiff and sore.  He moved very slowly.  He required standby assistance to transfer himself from chair to bed but had poor safety awareness and would not wait for assistance.  CMS Ex. 32 at 4 (Dyer Decl. ¶ 12). 

8)  Medications. R1 was prescribed and administered a long list of medications, including Opioids, that came with an even longer list of side effects that could make it unsafe for him to smoke without supervision.  Among those medications were: 

• Hydrocodone-acetaminophen, which is an opioid, used to treat pain.  CMS Ex. 14 at 59; CMS Ex. 7 at 61.  Its side effects include dizziness, drowsiness, lethargy, mental clouding, and impairment of physical and mental performance.  See Manuchehr Habibi & Peggy Y. Kim, Hydrocodone and Acetaminophen, National Library of Medicine, https://www.ncbi.nlm.nih.gov/books/NBK538530 (last updated Dec. 19, 2022) 
• Aricept and Namenda are administered to treat dementia.  Their side effects include seizures, dizziness, syncope, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue.  CMS Ex. 14 at 71, 72; see

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NAMENDA-memantine hydrochloride tablet NAMENDA-memantine hydrochloride kit, DAILY MED, National Library of Medicine, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba (last visited May 11, 2023); Anil Kumar, Vikas Gupta & Sandeep Sharma, Donepezil, National Library of Medicine, https://www.ncbi.nlm.nih.gov/books/NBK513257/ (last updated Dec. 22, 2021).  

• Tamsulosin is prescribed to treat prostate problems.  Its side effects include dizziness, lightheadedness, and drowsiness.  CMS Ex. 14 at 72; see Highlights of prescribing information, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf (last visited May 11, 2023).  
• Zofran is prescribed to treat nausea.  CMS Ex. 14 at 72.  Its side effects include fatigue and tremors.  Drugs and Supplements Ondansetron (Oral Route, Oromucosal Route), Mayo Clinic, https://www.mayoclinic.org/drugs-supplements/ondansetron-oral-route-oromucosal-route/side-effects/drg-20074421 (last visited May 11, 2023).  
• Voltaren is prescribed to treat pain from osteoarthritis.  CMS Ex. 14 at 73.  Its side effects include dizziness, drowsiness, and blurred vision.  Voltaren Side Effects Center, RxList, https://www.rxlist.com/voltaren-side-effects-drug-center.htm (last visited May 11, 2023).  

Any of these side effects could present real problems to a smoker, and, based on his medical records, we know that R1 experienced some of them – whether caused by his medications or underlying conditions does not make them any less dangerous.  Drowsiness, for example, puts an unsupervised smoker in danger.  A less alert (or dozing) resident is more likely to drop a match or lit pipe.  CMS Ex. 31 at 8 (Smith Decl. ¶ 22).  And, obviously, any smoker who loses consciousness is in trouble. 

9)  Absence of Consent.  With or without the verbal or written consent of the resident or responsible party, the facility must protect the resident from an avoidable accident and is ultimately responsible for the resident’s health, safety, and welfare.  42 C.F.R. § 483.25(d); see Logan Healthcare Leasing LLC d/b/a Logan Care & Rehab., DAB No. 3036 at 9, 13, 15 (2021).  Nevertheless, consent is also important.  The resident’s responsible party must consent to the facility’s determinations regarding a resident’s smoking. 

Because R1 was incompetent, he could not consent to his being allowed to smoke unsupervised.  Facility staff should have consulted his granddaughter for her approval.  42 C.F.R. § 483.10(c)(2) and (3).  

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R1’s granddaughter was not part of the interdisciplinary team.  She was not advised that the team had decided to allow her grandfather to smoke without supervision.  In her written testimony, she agrees that she consented to his smoking.  She has not denied that she understood that he had rejected the smokers apron (although she did not sign the form consenting to it).  However, she “never consented to [her] grandfather smoking unsupervised” at the facility.  She expected staff to be supervising him.  Indeed, she admitted him to the facility because she could not be around him 24/7 and worried about his being alone and unsupervised.  CMS Ex. 34 at 1-2 (Cotten Decl. ¶ 2); see CMS Ex. 31 at 6-7 (Smith Decl. ¶ 20) (admitting that she consented to his smoking but did not “remember them ever saying he was unsupervised.”). 

The facility promised R1’s granddaughter that R1 “would be supervised and safe.”  She selected the facility “to make sure that he was safe and supervised at all times.”  CMS Ex. 34 at 2 (Cotten Decl. ¶ 1).  R1’s granddaughter insists that, when her grandfather was allowed to smoke at the facility, she thought “safety precautions would be in place and that he would be supervised.”  CMS Ex. 34 at 3 (Cotten Decl. ¶ 3). 

The granddaughter’s testimony is unchallenged.  Although the DON and ADON assert that the granddaughter verbally agreed that R1 would not use a smoking apron, they do not claim that she agreed that he could smoke unsupervised, nor even that they told her he would be smoking unsupervised.  CMS Ex. 7 at 156; CMS Ex. 20. 

b.  The situation after March 3, 2021.  

1)  The facility’s revised smoking policy.  After R1’s death, the facility revised its smoking policy.  CMS Ex. 32 at 4 (Dyer Decl. ¶ 11).  The new policy, revised on March 3, 2021, was designed to “establish and maintain safe resident smoking practices.”  CMS Ex. 16 at 1.  Among other provisions, the policy provided that: 

• smoking-related privileges, restrictions, and concerns would be noted on the resident’s care plan, and all personnel would be alerted to those issues;
• the facility could impose smoking restrictions on residents at any time if the resident does not comply with the smoking policy; interventions could include alerting the ombudsman or licensing agencies, interdisciplinary team meetings, care conferences with the resident and/or representative, withdrawal of smoking privileges, possible discharge from the facility;
• all residents that elect to smoke while at [the facility] will do so under direct supervision of a staff member;
• the ADON will review the status of a resident’s smoking privileges periodically and consult, as needed, the DON and attending physician. 

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CMS Ex. 16 at 1. 

The policy lists requirements for “smoking articles”: 

• residents with smoking privileges must keep cigarettes, pipes, tobacco, or other smoking articles at the nurse’s station;
• residents may not have or keep lighters, matches, or lighter fluids in their personal possession at any time;
• residents with smoking privileges may not give or lend smoking articles to other residents or staff (anyone observing this must immediately report it to the on-duty charge nurse); 
• smoking is restricted to the designated smoking patio;
• residents are required to use the smokers apron at all times when smoking.  “A declination of the apron will result in revoking of their smoking privileges”;
• smokers will be provided a schedule that indicates specific times that smoking will be permitted in the smoking area under staff supervision;
• staff members may not purchase and/or provide any smoking articles for residents unless approved by the DON. 

CMS Ex. 16 at 1-2. 

2)  Residents 2 and 3 (R2 and R3).  That the facility did not supervise R1, who could not smoke safely if unsupervised, puts the facility out of substantial compliance with program requirements and more than justifies the relatively modest penalty imposed. 

Nevertheless, CMS points to two additional residents who were allowed to smoke unsupervised, notwithstanding conditions that could have made the practice unsafe. 

R2 was a 74-year-old woman, admitted to the facility on June 23, 2019.  She suffered from a long list of impairments, including chronic obstructive pulmonary disease and atherosclerosis of the arteries of both legs.  She had difficulty walking and required a wheelchair.  She required supplemental oxygen.¹¹    She was in chronic pain and had long

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term – and current – use of opiate analgesics.  She had a major depressive disorder and dementia.  CMS Ex. 11 at 1-2, 6, 12, 18, 42, 43, 52, 54; see CMS Ex. 32 at 5 (Dyer Decl. ¶ 14).  

R3 was a 74-year-old man, initially admitted to the facility on August 2, 2019, and readmitted, following a hospital stay, on May 5, 2020.  He also suffered from a long list of impairments, including acute respiratory disease and peripheral vascular disease.  He had congestive heart failure and chronic kidney disease.  He had generalized muscle weakness and difficulty walking.  He used a wheelchair.  His right leg had been amputated above the knee, and his left great toe had been amputated.  He had long term – and current – use of opioid analgesics.  He had a sleep disorder.  CMS Ex. 10 at 1-2, 15. 

Both residents were smokers, and, according to their smoking assessments – which predated the March 3, 2021 policy changes – both were allowed to smoke unsupervised and both had declined smoking aprons.  CMS Ex. 10 at 16-18; CMS Ex. 11 at 6-8. 

The parties agree that the two residents were allowed to smoke unsupervised and were not required to wear smoking aprons.¹²    They argue about whether the smoking assessments were accurate and about whether these residents should have been allowed to smoke unsupervised.  But the arguments are irrelevant.  Effective March 3, 2021, all residents who elected to smoke at the facility were required to do so “under [the] direct supervision of a staff member.”  CMS Ex. 16 at 1.  They were required to use a smokers apron “at all times when smoking.”  CMS Ex. 16 at 1.  If, in fact, R2 and R3 were smoking unsupervised, the facility was not complying with the facility’s revised smoking policies and was therefore not in substantial compliance with 42 C.F.R. § 483.25(d). 

A facility’s smoking policy may “play various roles in evaluating compliance with federal requirements.”  As here, it may show that the facility recognized the dangers of allowing its vulnerable residents to smoke, unsupervised.  “It may also show the standard of care the facility expected its staff to provide.”  Logan Healthcare, DAB No. 3036

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at 14, quoting Oxford Manor, DAB No. 2167 at 5 (2008); see Heritage House of Marshall Health and Rehab., DAB No. 3035 at 11 (2021), quoting Bivins Mem’l Nursing Home, DAB No. 2771 at 9 (2017); Emery County Care and Rehab., DAB No. 3006 at 11 (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 Oaks Health & Rehab. Ctr., DAB No. 1567 at 5 (2014) (holding that the methods a facility chooses to protect its residents are reflected in its policies, assessments, and care plans). 

2. The penalty imposed is reasonable. 

CMS imposed a $20,780 per-instance penalty, which is at the higher end of the penalty range in effect at the time ($2,233 to $22,320).  See 42 C.F.R. §§ 488.408(d); 488.438(a)(2); 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (January 17, 2020).  Considering what CMS might have imposed – a comparable per-day penalty for multiple days of substantial noncompliance – the penalty is modest.  See Plum City Care Ctr., DAB No. 2272 at 18-19 (2009) (observing that even the maximum per-instance CMP can be “a modest penalty when compared to what CMS might have imposed.”).  

The burden is on the facility to demonstrate, based on factors listed in 42 C.F.R. § 488.438(f), that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2017 at 22 (2017).  Except to argue that it was in substantial compliance, Petitioner here has come forward with no argument or evidence to establish that the penalty imposed is unreasonable.  It has therefore not established that any reduction is necessary, and I find that the penalty imposed –$20,780 per-instance – is reasonable. 

Conclusion

The evidence establishes that the facility was not ensuring that R1 received adequate supervision and assistive devices to prevent accidents.  The facility was therefore not in substantial compliance with 42 C.F.R. § 483.25(d).  The penalty imposed – $20,780 per-instance – is reasonable. 

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Endnotes

¹   CMS also determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(k) (Tag F697) – quality of care:  pain management.  CMS imposed no penalty for this deficiency, so it is not reviewable.  A facility may challenge a finding of noncompliance for which CMS imposes one of the penalties specified in 42 C.F.R. § 488.406.  42 C.F.R. § 498.3(b)(13); see 42 C.F.R. § 498.3(a).  A facility has no right to a hearing unless CMS imposes one of the specified remedies.  The remedy, not the citation of a deficiency, triggers the right to a hearing.  The Lutheran Home – Caledonia, DAB No. 1753 (2000).  

²   Deciding a case based on the written record does not mean that it is decided without a hearing.  In reviewing administrative appeals, courts recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a hearing, even if that hearing was not an “oral” or “evidentiary” hearing.  See CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”). 

³   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 July 22, 2021.  CMS Ex. 29; see 85 Fed. Reg. 2,869.  At the time this penalty was imposed (July 22, 2021), the range was from $2,233 to $22,320.  42 C.F.R. §§ 488.408(d), 488.438(a)(2); 45 C.F.R. § 102.3; 85 Fed. Reg. 2,869, 2,880 (Jan. 17, 2020). 

⁴   My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. 

⁵   The regulations governing long-term care facilities have been revised since these cases were decided; the requirement that facilities minimize the risk of accidents has been moved from 42 C.F.R. § 483.25(h) to 483.25(d).  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017).  However, the substance of the “quality of care” regulation requirements – which are statutory – has not changed, so decisions that pre-date the regulatory changes remain valid. 

⁶   The record includes duplicates of the March 3 revised policy.  Compare CMS Ex. 16 at 1-2 with CMS Ex. 16 at 3-4, CMS Ex. 16 at 8-9, and CMS Ex. 16 at 11-12. 

⁷   Surveyor Smith also points out that the facility is located in Northern California (Shasta County), an area prone to wildfires.  CMS Ex. 31 at 9 (Smith Decl. ¶ 26).  This creates additional obligations on the facility to prevent fires. 

⁸   In a statement dated February 25, 2021, the DON wrote that R1 pulled the emergency cord to alert staff.  CMS Ex. 20 at 2.  No supporting evidence confirms this claim.  In fact, more reliable evidence establishes that staff learned that the resident was on fire because the nurse aide, who was waiting for the breakfast cart, saw it on the monitor.  CMS Ex. 31 at 5 (Smith Decl. ¶ 14); see CMS Ex. 12 at 64. 

⁹   Smoking aprons are made of fire retardant/resistant material and protect residents from harm caused by dropped lit matches, cigarettes, pipes, or matches.  CMS Ex. 31 at 4 (Smith Decl. ¶ 11). 

¹⁰   The smoking assessment itself includes inaccuracies and inconsistencies regarding R1’s ability to understand and abide by safe smoking policies.  According to the checklist that is part of the assessment:  R1 did not agree to the facility’s smoking schedule; he did not understand and agree that smoking materials would be secured by staff; he did not understand and agree to use safety equipment provided by staff while smoking; and he did not understand and agree that the facility allows supervised smoking only (which was not true, although, according to the assessment form, his response meant that he would not be allowed to smoke, also not true).  CMS Ex. 13 at 2. 

¹¹   As CMS points out, there is no safe way to smoke around oxygen.  Even if the supplemental oxygen is turned off, oxygen can saturate a person’s clothing and hair.  A resident should not smoke for at least ten minutes after turning off supplemental oxygen.  CMS Reply at 10, citing CMS Ex. 32 at 6 (Dyer Decl. ¶ 19); CMS Ex. 36 at 3; CMS Ex. 37. 

¹²   Surveyor Dyer observed the two residents at 1:00 p.m. on March 26, 2021.  Both were wearing smoking aprons.  CMS Ex. 32 at 6, 8 (Dyer Decl. ¶¶ 17, 25).  R2 said that she did not mind wearing the apron but did not recall being offered one before R1’s accident.  CMS Ex. 32 at 6 (Dyer Dec. ¶ 17).  R3 concurred.  He said that he did not mind the smokers apron; in fact, he felt safer when he wore it.  He also said that the apron was not offered before R1’s accident.  The activity assistant helped R3 light his pipe, using an electric lighter.  R3 told the surveyor that matches were no longer allowed.  CMS Ex. 32 at 8 (Dyer Decl. ¶ 25).