Alden Terrace Convalescent Hospital, DAB CR5889 (2021)

DECISION

Alden Terrace Convalescent Hospital (Petitioner or “the facility”) is a long-term care facility in Los Angeles, California, that participates in the Medicare program.  Based on a survey completed on December 26, 2017, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with the Medicare participation requirements at 42 C.F.R. §§ 483.25(g)(1)-(3) and 483.70(p)(1),(2) and imposed separate per-instance civil monetary penalties (PICMPs) of $10,000 and $5,000, respectively.  For the reasons discussed below, I find that Petitioner was not in substantial compliance with Medicare program requirements and the remedies imposed are reasonable. 

I.  Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, a facility must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, any deficiencies may “pose no greater risk to resident health or safety than the potential for causing

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minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‑3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  CMS may impose a per-day civil monetary penalty (CMP) for the number of days an SNF is not in substantial compliance or a PICMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a). 

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

Surveyors from the California Department of Public Health Services (state agency) completed a recertification survey on December 26, 2017, at which time the state agency determined that the facility was not in substantial compliance with Medicare program participation requirements.  The state agency cited noncompliance with, inter alia, 42 C.F.R. §§ 483.25(g)(1)-(3) (Tag F692 – nutrition/hydration status maintenance) at the “G” level of scope and severity1 and 483.70(p)(1),(2) (Tag F850 - qualifications of social worker) at the “F” level of scope and severity.2   CMS Ex. 1 at 27-33, 47-50.

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In a letter dated March 5, 2018, CMS notified Petitioner that it concurred with the state agency’s findings and determined that Petitioner was not in substantial compliance with Medicare program participation requirements.  CMS Ex. 2.  CMS imposed a PICMP of $10,000 for Petitioner’s noncompliance with 42 C.F.R. § 483.25(g)(1)-(3), along with a separate PICMP of $5,000 for Petitioner’s noncompliance with 42 C.F.R. § 483.70(p)(1),(2).  CMS Ex. 2 at 2.

Petitioner, through counsel, timely requested a hearing on May 4, 2018.  Pursuant to an  Acknowledgment and Pre-Hearing Order (Pre-Hearing Order),3 CMS filed a pre-hearing brief (CMS Br.) and 15 proposed exhibits (CMS Exs. 1-15), and Petitioner filed a pre‑hearing brief (P. Br.) and 13 proposed exhibits (P. Exs. 1-13).  In the absence of any objections, I admit CMS Exs. 1-15 and P. Exs. 1-13 into the evidentiary record. 

Neither party has submitted a request for cross-examination of the other party’s witnesses.  See CMS Exs. 11, 12; P. Exs. 1, 3, 4, 11; Pre-Hearing Order §§ 8-10.  A hearing for the purpose of cross-examination is therefore unnecessary.  I consider the record in this case to be closed, and the matter is ready for a decision on the merits.

II.  Issues4

The issues presented are: 

Whether Petitioner failed to substantially comply with the participation requirement at 42 C.F.R. § 483.25(g)(1)-(3);

Whether Petitioner failed to substantially comply with the participation requirement at 42 C.F.R. § 483.70(p)(1),(2); and

If so, whether separate $5,000 and $10,000 per-instance CMPs are reasonable enforcement remedies.

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III.  Discussion5

A.  Petitioner did not ensure that Resident # 85 drank enough liquid and consumed enough food to meet her daily dietary requirements, maintain adequate hydration status, and reduce the risk of urinary tract infection, and it did not monitor Resident # 85 for the signs and symptoms of dehydration and urinary tract infection that are outlined in her care plans and facility policies; therefore, Petitioner failed to substantially comply with 42 C.F.R. § 483.25(g)(1)-(3).

Resident # 85’s admission, care planning, and facility policies related to her care

Resident # 85, a woman born in 1950, was initially admitted to the facility in February 2004 and was readmitted in June 2016.  CMS Ex. 3 at 1.  Resident # 85’s admission record reports medical diagnoses that include paranoid schizophrenia, diabetes mellitus (type 2) with long-term use of insulin, adult failure to thrive, anemia, hypothyroidism, major depressive disorder, and anxiety disorder.  CMS Ex. 3 at 1-2.  Resident # 85 lacked decision-making capacity.  CMS Ex. 3 at 1, 5.  A Minimum Data Set (MDS) assessment conducted in November 2017 revealed a Brief Interview for Mental Status (BIMS) summary score of “00,” which is indicative of severe cognitive impairment.6   CMS Ex. 3 at 48.  The MDS assessment also reported that Resident # 85 required as much as limited assistance with eating during the lookback period.  CMS Ex. 3 at 51.

A June 2016 admission assessment reported that Resident # 85 had missing and broken teeth and was put on a mechanical soft diet.  CMS Ex. 3 at 4.  Petitioner also noted that Resident # 85 was on a consistent carbohydrate diet.  CMS Ex. 3 at 4; see CMS Ex. 13 at 2 (reporting Resident # 85 was “on [a] therapeutic diet [secondary to diabetes mellitus]”).  Although the admission assessment form included fields to address whether Resident # 85 required assistance with eating and nutrition, Petitioner omitted this information.  CMS Ex. 3 at 4.

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Upon Resident # 85’s readmission in June 2016, a nutritional assessment determined that she would be served milk and juice with each meal.  CMS Ex. 13 at 1.  A registered dietician, in developing Resident # 85’s dietary “plan/approach,” determined that she had a daily basal energy requirement of 1,100 – 1,375 calories per day and required 1,100 - 1,375 ccs of water each day.  CMS Ex. 13 at 2.  A June 2016 nutritional assessment progress note on the same document reported that Resident # 85 “is not able to make her needs known.”  CMS Ex. 13 at 2.

Petitioner had a meal consumption charting guide that its staff used to document the amount of meal consumption by residents.  Milk constituted 20% of any meal, and juice constituted another 15% of a breakfast meal.  CMS Ex. 4 at 13.7    Thus, a resident who consumed milk and juice at breakfast, without any food, could have “fair” meal consumption based on having consumed 35% of the meal.  CMS Ex. 4 at 13; but see CMS Ex. 4 at 12 (reporting that 35% consumption of a meal is poor consumption).

A self-care deficits care plan reported that Resident # 85 required limited assistance with eating as a result of arthritis, seizure disorder, and depression.  CMS Ex. 3 at 75.  Nursing logs reflect self-performance of feeding at all meals served to Resident # 85 in September, October, and November of 2017.  P. Ex. 7 at 1, 3, 5, 7. 

Resident # 85 had a care plan to address her “risk for alteration in hydration status secondary to poor safety awareness,” with a goal of avoiding “unrecognized [signs and symptoms of] dehydration daily.”  CMS Ex. 3 at 71.  The care plan included interventions that Petitioner would “[a]ssess hydration status,” encourage fluids on meal trays, and observe for signs and symptoms of dehydration, to include “dry skin, dry oral mucosa, [and] decreased output.”  CMS Ex. 3 at 71.

Another care plan addressed Resident # 85’s “risk for dehydration,” with a goal that included Resident # 85 be “adequately hydrated as tolerated daily.”  CMS Ex. 3 at 73.  Interventions included observing “for decreased urine output” and “offer[ing] and encourag[ing] resident to increase fluid intake.”  CMS Ex. 3 at 73.

Petitioner had implemented a care plan to address Resident # 85’s risk for urinary tract infection (UTI).  CMS Ex. 3 at 72.  Interventions included “encourag[ing] fluid intake if no restriction” and notifying Resident # 85’s physician of signs and symptoms of UTI, which included a “change in urine character:  color, cloudy, odor, amount, clarity, etc.”  CMS Ex. 3 at 72.

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Petitioner’s nursing staff completed logs that recorded information such as meal consumption, the level of assistance provided at each meal, and bladder function.  P. Ex. 7.  Although the logs document the overall percentage of each meal consumed, the logs lack data regarding the amount of fluids consumed during meals or cumulatively throughout the day.  The same nursing staff logs also recorded a resident’s continence and the “# = of times or amount” of “bladder function” on each shift, but did not document the amount of urine output or the characteristics of urine.  See CMS Ex. 3 at 71 (alteration in hydration status secondary to poor safety awareness care plan); 72 (risk of UTI care plan); 73 (risk of dehydration care plan); see CMS Ex. 3 at 41-42 (forms used by Petitioner to log fluid intake, urine output, characteristics of urine, and symptomatology/indicators of UTI and dehydration).

Petitioner had a policy, “Dehydration – Measures to Identify and Manage,” that listed causes, signs, and symptoms of dehydration, which it defined as “depletion of water.”  CMS Ex. 4 at 3.  Petitioner reported that causes of dehydration included depressed food or fluid intake, diabetes mellitus, and the use of diuretics.  CMS Ex. 4 at 3.  The policy stated that signs and symptoms of dehydration included abnormal laboratory values, dry mucous membranes, and delirium manifested by, inter alia, “[a]nxiety, agitation.”  CMS Ex. 4 at 3.  Petitioner reported that blood chemistry testing for dehydration may include blood urea nitrogen (BUN), sodium, and creatinine levels, and it listed hydration measures that included intravenous fluids.  CMS Ex. 4 at 4.

Petitioner also had a policy to prevent UTIs, in which it reported that residents benefit from drinking “liberal mounts of water to lower bacterial concentrations in the urine.”  CMS Ex. 4 at 1.

On August 10, 2017, Petitioner initiated an Interdisciplinary Weight Management Care Plan to address Resident # 85’s then-recent weight loss.  CMS Ex. 3 at 33.  Petitioner reported that Resident # 85 was at risk for unavoidable weight loss due to depression, the use of diuretics/laxatives, adult failure to thrive, and anemia.  CMS Ex. 3 at 33.  Petitioner determined that Resident # 85 had a “problem” that she had lost five pounds in the previous month.  CMS Ex. 3 at 33.  Petitioner implemented a short-term goal that Resident # 85 “will consume 80-100% of the diet ordered daily [for] three months.”8   CMS Ex. 3 at 33.  Approaches included encouraging adequate nutritional intake as needed, assessing for reasonable food preferences, offering food substitutes as needed, assisting with eating and tray set-up as needed, and observing for signs and symptoms of dehydration.  CMS Ex. 3 at 33.

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Resident # 85’s meal consumption and her November 6-7, 2017 hospitalization

During the month of October 2017, Resident # 85 refused 17 breakfast meals, 21 lunch meals, and 14 dinner meals.9   P. Ex. 7 at 3.  Even when Resident # 85 refused meals, nursing logs reported self-performance of feeding by Resident # 85 without staff assistance.  P. Ex. 7 at 3; but see CMS Ex. 3 at 75 (care plan addressing that Resident # 85 required limited assistance with eating).  Resident # 85 accepted a snack on most days that month.  P. Ex. 7 at 3.  Petitioner’s Administrator, Renita Chan, and Petitioner’s Director of Nursing, Shirley Cruz, both testified that Petitioner “provides replacement meals, snacks and beverages” to Resident # 85, but that “no documentation is made by staff when a replacement meal or snack is provided to a resident.”  P. Exs. 3 at 1-2; 4 at 2. 

Logs reveal that Resident # 85 refused numerous meals between November 1 and 6, 2017.10  P. Ex. 7 at 5.  Of the six breakfast meals served during that timeframe, Resident # 85 refused two meals and had poor consumption of three other meals.  P. Ex. 7 at 5.  With respect to six lunch meals served between November 1 and 6, 2017, Resident # 85 refused four meals and had poor consumption of the other two meals.  P. Ex. 7 at 5.  And with respect to the five dinner meals offered to Resident # 85 during that time frame, Resident #25 refused two dinner meals and had only 40% consumption of another meal.  P. Ex. 7 at 5.  Thus, over the course of 17 meals, Resident # 85 completely refused eight meals and had 30% or less consumption of five other meals.  P. Ex. 7 at 5.  Resident # 85 also refused snacks on three of the five days between November 1 and 6 when she was offered snacks.  P. Ex. 7 at 5.  Notably, in the two-day period between November 2 and 3, 2017, Resident had 20% or less consumption of three meals, refused two meals, and refused a snack.  P. Ex. 7 at 5.  Thereafter, beginning on November 5, 2017, and continuing through lunch on November 6, 2017, Resident # 85 refused all five meals offered to her, along with a snack.  P. Ex. 7 at 5.  Petitioner reported that Resident # 85 self-performed feeding at all meals.  P. Ex. 7 at 5.

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At 10:30 am on November 6, 2017, Resident # 85’s physician ordered her transfer to an acute care hospital for “evaluation/treatment [secondary] to failure to thrive.”  CMS Ex. 3 at 16.

On November 6, 2017, Petitioner transferred Resident # 85 to an acute care hospital emergency department, at which time she was diagnosed with dehydration and a UTI.  CMS Ex. 3 at 7, 12.  An assessment of Resident # 85’s ears, nose, mouth, and throat revealed that she had “[v]ery dry mucous membranes.”  CMS Ex. 3 at 8; see CMS Ex. 3 at 29 (dehydration risk assessment reporting that “dry mucous membranes” is an indicator of dehydration).  The evaluating physician assessed that Resident # 85 was “very agitated” and was “yelling and screaming” and reported that she had been placed in two-point restraints while en route to the hospital via ambulance.11   CMS Ex. 3 at 7-8; see P. Ex. 7 at 5 (daily nursing logs documenting that two-point restraints had not been used on Resident # 85); CMS Exs. 3 at 29 (dehydration risk assessment reporting change in mental status as a risk factor); 4 at 3 (facility dehydration policy identifying “anxiety, agitation” as a sign and symptom of dehydration).  Laboratory testing revealed a BUN level of 25.0 mg/dL, which was elevated based on the laboratory’s reported reference interval of normal values of 7.0 – 18.0 mg/dL.  CMS Ex. 3 at 10.  Treatment provided by the hospital included intravenous fluids and antibiotics.  CMS Ex. 3 at 12-13. 

The hospital reported at 7:41 pm, several hours after her initial presentation, that Resident # 85 was “[l]ess agitated” and that “labs revealed dehydration.”  CMS Ex. 3 at 12.  Shortly thereafter, at 7:58 pm, a hospital attending physician discussed Resident # 85’s care with her physician, Dr. Golchini, at which time the stated plan was to discharge Resident # 85 after she received intravenous fluids, if all other tests were normal.  CMS Ex. 3 at 13.  At 10:13 pm, a hospital attending physician reported that she had transferred care to another physician and that Resident # 85 would be re-checked after the completion of urinalysis testing and the administration of intravenous fluids.  CMS Ex. 3 at 13.  The hospital obtained a sample for urinalysis at 11:35 pm.  CMS Ex. 3 at 10.  Urinalysis testing revealed, inter alia, many bacteria, a hazy appearance, and positivity for nitrites and ketones.  CMS Ex. 3 at 10-11.  Resident # 85 was re-checked at 1:57 am, at which time she was stable, resting comfortably, and improving with treatment.  CMS Ex. 3 at 12.  The attending physician reported she would be discharged following the administration of antibiotics.  CMS Ex. 3 at 12.

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Early in the morning of November 7, 2017, Resident # 85 returned to the facility with an order for a one-week course of antibiotics for treatment of her UTI.  CMS Ex. 3 at 40.  Hospital discharge instructions for UTI instructed Resident # 85 to “[d]rink enough fluid to keep [her] pee clear or pale yellow.”  CMS Ex. 3 at 14.  Later that morning, Resident # 85’s physician, Dr. Golchini, issued an order to continue antibiotic therapy for one week.  CMS Ex. 3 at 40.  That same day, Petitioner completed a change of condition form for a “situation identified” of UTI.  CMS Ex. 3 at 31.  Petitioner also implemented an antibiotic therapy care plan, dated November 7, 2017, for treatment of Resident # 85’s UTI, at which time it reported she had a health-care associated infection and “[m]eets the criteria for true infection per facility policy.”  CMS Ex. 3 at 6. 

Petitioner submitted the written direct testimony of Hossein Babaali, MD, who reported that he “work[s] with” Resident # 85’s physician, Dr. Golchini.  P. Ex. 1 at 1.  Dr. Babaali stated that Resident # 85 had been his patient for “many years” and opined that Resident # 85’s “clinical lab results from her hospital transfer on November 6, 2017 . . . do not support a diagnosis of dehydration.”  P. Ex. 3 at 1-2.  Dr. Babaali did not address Resident # 85’s hospital diagnosis of UTI.

Another physician, Thomas A. Woodbury, DO, submitted written direct testimony explaining that Petitioner had sent him unspecified “documents for review and analysis” and had asked that he provide “expert analysis and findings on these documents.”  P. Ex. 11 at 2.  The following discussion reflects Dr. Woodbury’s “analysis”:  

Based on my review of the medical records, I have determined Resident 85 was adequately hydrated and nourished at [the facility] prior to her transfer to [the hospital] on November 6, 2017.  The clinical lab results, from measurements taken while Resident 85 was admitted to [the hospital], also demonstrate that Resident 85 did not present signs of clinical dehydration and did not present adequate signs for a diagnosis of Urinary Tract Infection.

P. Ex. 11 at 2.  Dr. Woodbury, in a conclusory sentence, stated that Resident # 85 “was neither malnourished nor dehydrated in the days immediately prior to, and during November 6th and 7th of 2017, and that a UTI was misdiagnosed at the acute care facility.”  P. Ex. 11 at 2.

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Upon Resident # 85’s return to the facility, she continued to self-perform feeding for the remainder of the month November,12 even while refusing at least 35 meals offered during that time period.13   P. Ex. 7 at 7.  Records do not indicate monitoring of Resident # 85’s total food and liquid consumption.

Analysis

42 C.F.R. § 483.25(g)(1)-(3) provides the following:

(g) Assisted nutrition and hydration.  [Based] on a resident’s comprehensive assessment, the facility must ensure that a resident—

(1)  Maintains acceptable parameters of nutritional status, such as usual body weight or desirable body weight range and electrolyte balance, unless the resident’s clinic condition demonstrates that this is not possible or resident preferences indicate otherwise;

(2)  Is offered sufficient fluid intake to maintain proper hydration and health; and

(3)  Is offered a therapeutic diet when there is a nutritional problem and the health care provider offers a therapeutic diet. 

Petitioner failed to substantially comply with 42 C.F.R. § 483.25(g)(1)-(3) when it failed to take measures to ensure compliance with the “plans/approach” that Resident # 85 drink 1,100 - 1,375 ccs of water and consume 1,000 - 1,375 calories of nourishment per day.  CMS Ex. 13 at 2.  Even though Petitioner recognized that Resident # 85 “refus[ed] to follow her prescribed diet at times” and “prefer[red] to eat in-between meal snacks,” Petitioner did not have a mechanism to monitor whether replacement meals and snacks adequately replaced the fluids and nourishment Resident # 85 was denied when she refused meals.  P. Br. at 4-5.  In fact, the Administrator and Director of Nursing

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recognized that “no documentation is made by staff when a replacement meal or snack is provided to a resident.”  P. Exs. 3 at 2; 4 at 2.  And even though Resident # 85’s dehydration care plan required that she be “adequately hydrated” (CMS Ex. 3 at 73), Petitioner had no means of determining whether Resident # 85, who was “[a]t risk for alteration in hydration status secondary to poor safety awareness,” drank enough throughout the day to receive adequate hydration.  CMS Ex. 3 at 71 (care plan for dehydration risk); see CMS Ex. 13 at 2 (nutritional assessment progress notes reporting “resident is not able to make her needs known”).  Likewise, Petitioner’s UTI policy stated that residents benefit from drinking “liberal amounts of water to lower bacterial concentrations in the urine” (CMS Ex. 4 at 1), yet Petitioner did not have a means to ensure that it offered Resident # 85 an adequate amount of water to meet her daily needs, much less a “liberal amount” of water to reduce the risk of UTI. 

Not only did Petitioner not monitor Resident # 85’s overall fluid and nutritional intake, as required by her dietary plan/approach, care plans, and its policies, but it also failed to monitor for  “decreased output” as required by her UTI care plan.  CMS Ex. 3 at 71.  Rather, Petitioner logged only the “# = of times” Resident # 85 had “bladder function” on each shift, without monitoring the amount of output.  P. Ex. 7 at 2, 4, 6, 8.  Further, Resident # 85’s UTI care plan addressed that a change in urine character (e.g., color, cloudy, odor, amount, clarity, etc.) is a sign or symptom of UTI that requires physician notification (CMS Ex. 3 at 72), but again, Petitioner only logged the “# = of times” with respect to “bladder function,” without assessing or documenting the characteristics of urine.  P. Ex. 7 at 2, 4, 6, 8. 

Petitioner claims that it transferred Resident # 85 to the hospital as a “precautionary measure after an uncharacteristic day in which she refused to eat or drink anything.”  P. Br. at 4; See P. Ex. at 2 (testimony of Petitioner’s Administrator, Renita Chan, that Petitioner transferred Resident # 85 to the hospital “as a precaution for her obstinate refusal to eat or drink anything for a period of more than 24 hours”).  Petitioner fails to acknowledge that such an episode was not necessarily uncharacteristic for Resident # 85.  For example, only a few days earlier on November 2-3, 2017, Petitioner consumed only 10% of breakfast and 20% of lunch, refused both a snack and dinner, and then ate only 20% of breakfast and refused lunch the next day, consuming the equivalent of a half meal over a span in which five meals and a snack had been served.  P. Ex. 7 at 5.  Further, immediately after Resident # 85 had been discharged from the hospital on November 7, 2017, after being diagnosed with dehydration and UTI, she refused the following meals:  breakfast and dinner on November 7, dinner on November 8, and breakfast, lunch, and a snack on November 9, 2017.14   P. Ex. 7 at 7; CMS Ex. 3 at 40.  Surprisingly, even though an interdisciplinary team, on November 10, 2017, addressed Resident # 85’s refusal to

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wear an identification bracelet, receive care/hygiene, wear shoes/appropriate clothing, take prescribed medications, and allow laboratory specimens to be collected, it indicated that a subject of its meeting did not include a concern area of Resident # 85’s “[r]efusal to follow prescribed diet.”  CMS Ex. 3 at 68.  And despite Resident # 85’s refusal of meals and snacks immediately upon her discharge from the hospital, Petitioner did not track overall liquid consumption or output to ensure she remained adequately hydrated, much less consumed “liberal amounts of water” or drank “enough fluid to keep [her] pee clear or pale yellow.”15   P. Ex. 7 at 6; see CMS Exs. 3 at 14, 73; 4 at 1.

Petitioner claims that Resident # 85, a diabetic, was an “avid snacker” who “eats cookies, chips, sodas, juices and even replacement meals offered by the kitchen.”  P. Br. at 3.  Yet, Petitioner acknowledges that it did not monitor the snack and replacement meals offered to Resident # 85, and therefore, it did not collect data to ensure that Resident # 85 was, in fact, replacing the liquids and nourishment that she lost when she refused meals.  See P. Exs. 3 at 2; 4 at 2 (testimony by both the Administrator and Director of Nursing that “[Petitioner’s] policy is to document when a resident refuses a meal.  However, no documentation is made by staff when a replacement meal or snack is provided to a resident.”). 

Petitioner argues that any failure to meet the requirements of 42 C.F.R. § 483.25(g)(1)-(3) did not cause a potential for more than minimal harm.  Petitioner largely bases this claim on its dispute of the diagnoses of dehydration and UTI provided by the hospital emergency department in November 2017.  P. Br. at 4-10.

Petitioner speculatively argues, without citation to any supporting evidence, that it would have been “impossible” for the hospital emergency department to obtain a clean-catch urine sample to perform the urinalysis testing that apparently supported the UTI diagnosis.  P. Br. at 8-9.  Specifically, Petitioner argues the hospital “inexplicably” was “able to collect a mid-stream urine specimen” from Resident # 85 when her “high level of agitation and combativeness” would have made such a task “impossible.”  P. Br. at 8-9.  Petitioner essentially accuses the hospital of fabricating its report that it obtained a clean‑catch urine specimen for testing.

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When Petitioner transferred Resident # 85 to the hospital prior to 3:00 pm on November 6, 2017, she was “[v]ery agitated,” had been “[y]elling and screaming,” and had been placed in two-point restraints by EMS personnel.  CMS Ex. 3 at 7-8.  However, after the hospital diagnosed dehydration and began to administer intravenous fluids, the hospital reported, prior to 8:00 pm, that Resident # 85 was “[l]ess agitated.”16  CMS Ex. 3 at 12.  After continued treatment and the passage of more time, the hospital reported late that night that Resident # 85 was “stable,” “improving with treatment,” and “resting comfortably.”  CMS Ex. 3 at 12.  Notably, the hospital did not obtain the urine specimen until shortly before midnight, which was more than eight hours after Resident # 85 arrived at the hospital.  CMS Ex. 3 at 7, 10, 12.  Petitioner has not factually demonstrated that Resident # 85 had a “high level of agitation and combativeness” that would have made it “impossible” for the hospital emergency department to obtain a urine specimen from her at 11:35 pm.  P. Br. at 8-9; see CMS Ex. 3 at 10-11.

Petitioner also argues that the hospital emergency department did not meet the “standard of practice” in assessing UTI, in that its diagnosis of UTI was based on urinalysis testing rather than a urine culture.  P. Br. at 8-9.  Petitioner fails to recognize that a urine culture is not a quick turn-around laboratory test such that it would be useful for purposes of diagnosis by an emergency department, where patients ordinarily remain for hours, not days.  The processing of a urine culture requires time, typically 24-48 hours, for any bacteria or yeast in the sample to multiply and grow.  See, e.g., Medline Plus, National Library of Medicine, “Urine Culture,” https://medlineplus.gov/ency/article/003751.htm (last visited June 16, 2021).  Being that the hospital attending physician and Petitioner’s physician had already determined, prior to 8:00 pm, that Resident # 85 was expected to be discharged “if all other tests are normal,” it would have been illogical for the hospital to defer a diagnosis of UTI and withhold treatment pending urine culture results when urinalysis testing otherwise supported a diagnosis of UTI.  CMS Ex. 3 at 12.  The urinalysis testing, which was completed less than 20 minutes after the specimen was obtained at 11:35 pm, reported several abnormal laboratory values that can be indicative of UTI.  CMS Ex. 3 at 10-11; see, e.g., National Institute of Diabetes and Digestive and Kidney Disease, Urinary Tract Infection – Diagnosis, https://www.niddk.nih.gov/health-information/urologic-diseases/bladder-infection-uti-in-adults/diagnosis (last visited June 16, 2021) (reporting that urinalysis can identify infection based on the presence of bacteria and white blood cells and that a urine culture, which “is not required in every case,” can “find out what type of bacteria is causing the infection”). 

Further, Petitioner’s own physician, Dr. Golchini, did not question the diagnosis of UTI.  In fact, upon Resident # 85’s release from the hospital, Dr. Golchini prescribed the same

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one-week course of antibiotics that had been prescribed by the hospital emergency department.  CMS Ex. 3 at 28, 40.  Likewise, Petitioner implemented an antibiotic therapy care plan on November 7, 2017, at which time it did not question the diagnosis of UTI.  Significantly, Petitioner determined the diagnosis “[m]eets the criteria for true infection per facility policy.”  CMS Ex. 3 at 6.  Further, Petitioner documented that Resident # 85 had a change in condition due to UTI, at which time it reported, under the heading of “(A)ssessment/evaluation,” that the “[o]verall appearance [was] suggestive of . . . UTI.”  CMS Ex. 3 at 31.  With respect to Dr. Woodbury’s opinion that “clinical lab results . . . demonstrate that Resident 85 . . . did not present adequate signs for [UTI],” the opinion fails to identify the specific clinical lab results or “adequate signs” that would support a diagnosis of UTI.  P. Ex. 11 at 2.

Petitioner also argues that the hospital incorrectly diagnosed dehydration.  P. Br. at 5-8.  Dr. Babaali argued that Resident # 85 did not have dehydration based on her sodium, bicarbonate, hemoglobin, and specific gravity laboratory results.  P. Ex. 1 at 2.  Dr. Babaali also remarked that Resident # 85 was normotensive and not tachycardic.  P. Ex. 1 at 2.  However, Dr. Babaali did not address that Resident # 85 had “very dry mucous membranes” and was “very agitated” when assessed at the hospital.  CMS Ex. 3 at 8;  see CMS Ex. 3 at 29 (dehydration risk factors form); 71 (dehydration care plan reporting dry oral mucosa as a sign and symptom of dehydration).  Dr. Babaali also did not address that Resident # 85 had an elevated BUN level that was 7 mg/dL higher than the high end of the reference interval range provided by the laboratory that performed the testing.  P. Ex. 1; CMS Ex. 3 at 10; see CMS Ex. 3 at 29 (reporting an elevated BUN level as a factor in the dehydration risk assessment); 38 (multidisciplinary progress record reporting an elevated BUN level on November 7, 2017).

Without any supporting explanation, Dr. Woodbury testified that Resident # 85 “was adequately hydrated and nourished” at the facility and that “clinical lab results . . . also demonstrate that [she] did not present signs of clinical dehydration . . . . ”  P. Ex. 11 at 2.  Again, Dr. Woodbury did not support his opinion, nor did he identify the signs of clinical dehydration that would have supported such a diagnosis. 

Petitioner also argues that Resident # 85’s BUN level was not elevated based on the reference interval range of another laboratory that did not perform the testing.  P. Br. at 6 (citing P. Ex. 8 at 1).  Pursuant to 42 C.F.R. § 493.1291, a laboratory is required to determine its own “reference intervals” or “'normal values.”  Petitioner is mistaken that it can simply “mix and match” one laboratory’s testing result with another laboratory’s reported reference intervals and normal values.

Even accepting, for purposes of this discussion, that the hospital emergency department misdiagnosed Resident # 85 with both dehydration and UTI, then it is unclear why the hospital held and treated her for more than 12 hours.  See CMS Ex. 3 at 7, 14.  Regardless of any diagnosis of dehydration and UTI (or lack thereof), Resident # 85 presented with

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very dry mucous membranes and in a very agitated state, symptoms Petitioner has associated with dehydration.  CMS Ex. 3 at 8; see CMS Ex. 4 at 3.  And even if Resident # 85 did not have a diagnosis of dehydration and UTI, her condition coincidentally improved after the administration of intravenous fluids and antibiotics, to include exhibiting less agitation and ultimately resting comfortably.  CMS Ex. 3 at 12.  Further, Resident # 85 had laboratory results that can be indicative of dehydration.  CMS Ex. 3 at 10-11; see CMS Exs. 3 at 29; 4 at 3-4.  Likewise, even if the “diagnosis of UTI by the acute hospital was made in error,” as Petitioner claims (P. Br. at 9), urinalysis testing revealed abnormal laboratory findings that can be indicative of UTI.  CMS Ex. 3 at 10-11.  And even if Petitioner disputes the hospital’s diagnosis of UTI, Petitioner  independently determined that Resident # 85’s UTI diagnosis “[m]eets the criteria for true infection per facility policy.”  CMS Ex. 3 at 6.  The evidence establishes that Resident # 85 was symptomatic for dehydration and UTI and improved with treatment.  Petitioner has not shown error in CMS’s determination that it failed to substantially comply with 42 C.F.R. § 483.25(p)(1)-(3).

B.  Petitioner concedes that the social services designee who performed social work services lacked a year of supervised social work experience in a health care setting working directly with individuals.  Petitioner failed to substantially comply with 42 C.F.R. § 483.70(p)(2) by not employing a social services designee with the requisite professional experience. 

Pursuant to 42 C.F.R. § 483.70(p)(1),(2), the individual serving in the role of a qualified social worker for a facility with more than 120 beds must meet education and work experience requirements.  See CMS Ex. 1 at 48 (reporting Petitioner had a census of 186 residents).  As relevant here, the individual serving in the role of a social worker must have “[o]ne year of supervised social work experience in a health care setting working directly with individuals.”17   42 C.F.R. § 483.70(p)(2).  Petitioner “does not dispute that [its social services designee] does not have one year of supervised social work experience in a health care setting working directly with individuals.”  P. Br. at 10.  Therefore, Petitioner has conceded it did not meet the requirements of 42 C.F.R. § 483.70(p)(2).

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Petitioner argues that it was in substantial compliance with 42 C.F.R. 483.70(p)(1),(2) because its failure to meet regulatory requirements did not have the potential to cause more than minimal harm to resident health and safety.  P. Br. at 9-10; see 42 C.F.R. § 488.301.  CMS argues that “[w]ithout proper training and experience, [Petitioner’s] social services designee was unlikely to be able to provide high quality social work services.”  CMS Br. at 7 (citing CMS Ex. 11).

In October 2016, CMS finalized a rule that revised Medicare participation requirements for SNFs, at which time it relocated and revised the regulatory participation requirement pertaining to social workers in SNFs with at least 120 beds.  81 Fed. Reg. 68,688, 68,800‑02 (Oct. 4, 2016).  CMS remarked that comments received in response to the proposed rule “agreed with the one year of supervised social work experience in a health care setting working directly with individuals.”  Id. at 68,801.  In addressing the role of social workers, CMS discussed comments that social workers assisted in fulfilling other participation requirements, such as “promoting quality of care and quality of life for all residents (§ 483.25), advocating for residents’ rights and helping facilities uphold those rights (§ 483.10), preventing and addressing abuse, neglect, and exploitation of older adults and other . . . residents (§ 483.12), and facilitating transitions of care and discharge planning (§ 483.15 and § 483.20).”  Id. at 68,800.  Further, CMS addressed comments that “professional social workers” were “well-equipped” to do the following:  strengthen communication among residents, families, and staff; facilitate financial and medical decision making, including advance care planning; and provide “individual, family and group counseling related to illness, disability, treatment, interpersonal relationships, grief, loss, dying, and death.”  Id. at 68,800-801.

The Medicare participation requirement at 42 C.F.R. § 483.70(p)(2), for good reason, requires that the individual providing social work services have at least one year of supervised experience in a health care setting.  As addressed by CMS in its final rule (citing a comment by the National Nursing Home Social Work Network’s Policy Committee), social workers have an important role in “ensuring residents’ quality of care and quality of life.”  Id. at 68,801.  One state agency surveyor, Ms. Diouare, remarked that Petitioner’s failure to employ a social services designee with the requisite experience “created a potential for more than minimal harm because a social worker plays an important role in the life of a nursing home resident.”  CMS Ex. 11 at 2.  Ms. Diouare further explained:  “Some of the responsibilities of a social worker include facilitating any identified problems e.g., dental, visual, communication, addressing resident’s needs, linking social supports, and physical care and physical environment to enhance quality of life.”  CMS Ex. 11 at 2.

Petitioner has not demonstrated that it was in substantial compliance with this participation requirement.  To the extent it argues that the lack of any other citations to social services deficiencies during the December 2017 survey demonstrates substantial compliance with the instant requirement, such an argument is unpersuasive.  P. Br. at 10.

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A social worker (or social services designee) may address and resolve a myriad of issues on a daily basis.  A year of supervised experience in a health care setting working with individuals expectedly produces a more capable social worker who can hit the ground running; such an individual would expectedly exercise better professional judgment and communication skills in the resident environment.  Without a year of prior supervised experience, the social services designee who provided social work services for Petitioner lacked the benefit of supervisory observations, feedback, and training.  With the important role of social work with respect to quality of care, abuse and neglect, care planning, and transition planning issues, Petitioner’s social services designee lacked the requisite level of supervised professional experience, which posed a potential for more than minimal harm to resident health and safety. 

C.  A PICMP of $10,000 is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.25(g)(1)-(3), and a PICMP of $5,000 is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.70(p)(1),(2).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  42 C.F.R. § 488.406(a)(3).  In determining whether the CMP amount imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3).  These factors include:  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) the factors specified at 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  Id.  The factors at 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

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, in light of the above 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.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 (2002).

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At the time of the survey, the baseline CMP range was from $1,000 to $10,000 prior to adjustment for inflation.  42 C.F.R. § 488.438(a)(2).  With inflation adjustment, the CMP range at the time of the survey was $2,097 to $20,965.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3; 82 Fed. Reg. 9174, 9182 (Feb. 3, 2017) (setting 2017 inflation adjustments).  CMS imposed a CMP of $10,000 for the noncompliance with 42 C.F.R. § 483.25(g)(1)-(3), which falls in the middle of the per-instance penalty range, and a separate CMP of $5,000 for the noncompliance with 42 C.F.R. § 483.70(p)(1),(2), which is at the lower end of the CMP range. 

Petitioner argues “[t]he imposition and amount of civil money penalties are unreasonable, inappropriate, and legally unsubstantiated.”  P. Br. at 11.  Petitioner also states that “CMS failed to appropriately consider the factors set forth in 42 C.F.R. § 488.438(f) and § 488.404.”  P. Br. at 11. 

The record does not evidence a history of noncompliance, and Petitioner has not offered any evidence showing an inability to pay a combined CMP of $15,000.  In light of Petitioner’s culpability, the CMPs are entirely reasonable.  Petitioner disregarded its own policies and resident care planning and failed to ensure that Resident # 85, a severely cognitively impaired resident who could not make her needs known, consumed an adequate quantity of liquids and nourishment on a daily basis.  Further, an individual who lacked the requisite supervised professional experience performed the important duties of a social worker.  Separate $5,000 and $10,000 CMPs are reasonable enforcement remedies for Petitioner’s noncompliance.

IV.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.25(g)(1)-(3) and 483.70(p)(1),(2).The imposition of separate $5,0000 and $10,000 CMPs is a reasonable enforcement remedy.

1. Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 161, effective September 23, 2016 (applicable at the time of the survey at issue)); see SOM, chap. 7, § 7400.3.1 (Rev. 185, effective November 16, 2018) (current version)); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “G” indicates an isolated instance of actual harm that is not immediate jeopardy to resident health or safety, and a scope and severity level of “F” indicates a widespread deficiency that did not cause actual harm, but that has the potential to result in more than minimal harm.
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2. Although the state agency cited other deficiencies during the survey, CMS imposed remedies based only on the two aforementioned deficiencies.  CMS Ex. 2 at 2; see CMS Ex. 1.  Neither party presented arguments regarding the other cited deficiencies in its briefing, and I do not address those deficiencies herein.  See 42 C.F.R. § 498.70(b); see, e.g., Golden Living Ctr.-Grand Island Lakeview, DAB No. 2364 (2011) (holding that it is the imposition of a remedy, not the citation of a deficiency, that triggers a facility’s right to a hearing under 42 C.F.R. pt. 498).
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3. This case was reassigned to me on March 8, 2019.
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4. With respect to the cited deficiencies, Petitioner limited its arguments to whether it was “in substantial compliance” with Medicare participation requirements.  P. Br. at 2; see C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii).
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5. 5  Findings of fact and conclusions of law are in italics and bold font.
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6. A BIMS summary score of 0 is the minimum possible score on a scale of 0 to 15.  See Long‑Term Care Facility Resident Assessment Instrument (RAI) 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score) at C-14, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited June 16, 2021).
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7. A hot beverage did not factor into meal consumption.  A supplemental drink, such as a juice served during the lunch and dinner meals, “is not figured in the percentage of food eaten.”  CMS Ex. 4 at 13.
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8. The care plan reported that Resident # 85 was currently on a small-portion diet.  CMS Ex. 3 at 33.
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9. This data, along with the vast majority of documentation regarding Resident # 85’s care at the facility, is handwritten.  Therefore, legibility can subject the data to different interpretations.  In such instances, I weighed any ambiguity in favor of Petitioner.
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10. Even though the surveyors addressed this log reporting, inter alia, meal consumption between November 1 and 6, 2017, CMS inexplicably and inexcusably stated that “[t]he tracking sheet for the first five days in November 2017 is blank.”  CMS Br. at 3 (citing CMS Ex. 3 at 27).  CMS further alleged that “[f]or the five days prior to Resident 85’s hospitalization, no one at Alden Terrace even bothered to complete the meal tracking portion of her Activities of Daily Living Sheet.”  CMS Br. at 5 (citing CMS Ex. 3 at 27).  Contrary to CMS’s erroneous claims in its brief, this document was available at the time of the survey, reviewed by the surveyors, and addressed in the statement of deficiencies.  CMS Ex. 1 at 31.
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11. Resident # 85’s behavior apparently prompted the hospital to run blood and urine toxicology screenings, to include testing for alcohol intoxication and the presence of prescription and illicit drugs.  CMS Ex. 3 at 11.
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12. Based on the nursing assistant logs, it is unclear how Petitioner determined in the November 14, 2017 MDS assessment that Resident # 85 required as much as a one‑person physical assist with eating during the lookback period.  Compare P. Ex. 7 at 5, 7 with CMS Ex. 3 at 51.
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13. Petitioner did not document Resident # 85’s consumption of breakfast, lunch, and snacks on November 7 and 8, 2017.  P. Ex. 7 at 5, 7.  This is noteworthy because progress notes document the refusal of at least one meal during that time frame.  CMS Ex. 3 at 40.
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14. Petitioner’s logs do not document Resident # 85’s consumption of breakfast, lunch, and snacks on November 7-8, 2017.  P. Ex. 7 at 5, 7.
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15. In response to Petitioner’s explanation that Resident # 85 “was transferred to an emergency facility as a precautionary measure after an uncharacteristic day in which she refused to eat or drink anything” (P. Br. at 4), I also note that approximately two months earlier, on September 9-10, 2017, Resident # 85 refused four consecutive meals and a snack.  P. Ex. 7 at 1.  Specifically, Resident # 85 did not eat lunch, dinner, or a snack on September 10, nor did she eat breakfast or lunch on September 11, 2017.  P. Ex. 7 at 1.  It is unclear why such a “precautionary measure” of transfer to a hospital was necessary only on November 6, 2017.
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16. Based on Petitioner’s dehydration policy, a decrease in agitation after receiving hydration would not be unexpected.  CMS Ex. 4 at 3 (listing agitation as a manifestation of dehydration).
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17. The survey also cited noncompliance with 42 C.F.R. § 483.70(p)(1), which pertains to educational requirements for a facility social worker.  CMS Ex. 1 at 47-50.  Subsequent to the December 2017 survey, Morningside Evaluations reported that the facility social worker, who had been educated in another country, had attained “the equivalent of a Bachelor of Science degree in Psychology from an accredited institution of higher education in the United States.”  P. Ex. 10 at 1.
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