Green Village Skilled Nursing & Rehabilitation, DAB CR5674 (2020)

DECISION

In this case, I consider a long-term care facility’s obligation to prevent and treat pressure ulcers.

Petitioner, Green Village Skilled Nursing & Rehabilitation (Green Village, Petitioner or facility), is a long-term care facility, located in Akron, Ohio, that participates in the Medicare program.  Based on an annual certification survey completed July 20, 2017, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements.  CMS imposed a civil money penalty (CMP) of $1,210 per day for 61 days for a total of $73,810.  Further, should the final total penalty exceed $10,483, the facility would be prohibited from conducting or offering a nurse aide training and competency evaluation program (NATCEP) for a period of two years.  Petitioner timely appealed.

The case was docketed and assigned to Administrative Law Judge Leslie A. Weyn.  On April 10, 2018, Judge Weyn issued an Acknowledgment and Pre-Hearing Order (Pre-hearing Order), which, among other things, directed the parties to submit written direct testimony for each of their proposed witnesses.  That Pre-hearing Order also stated an in-person hearing would only be necessary if the opposing party requested an opportunity to

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cross-examine a witness.  Pre-hearing Order at 6-7; see, e.g., HeartFlow, Inc. DAB No. 2781 at 17-18 (2017) (holding that the use of written direct testimony for witnesses is permissible so long as the opposing party has the opportunity to cross-examine those witnesses).

Pursuant to the Pre-hearing Order, CMS filed a pre-hearing brief with an incorporated motion for summary judgment (CMS Br.) and 15 proposed exhibits (CMS Exs. 1-15), and Petitioner filed a pre-hearing brief and response to CMS’s motion for summary judgment, with two proposed exhibits (P. Exs. 1-2).  CMS submitted the written direct testimony of one witness (CMS Ex. 15), and Petitioner submitted the written direct testimony of two witnesses (P. Exs. 1-2).

On April 24, 2020, this case was reassigned to me.

Neither Petitioner nor CMS objected to the admission of any of the proffered exhibits nor requested an opportunity to cross-examine a witness.  Therefore, a hearing for the purpose of cross-examination of a witness is unnecessary.  Pre-hearing Order at 6-7.  The matter is ready for a decision on the merits.  As an in-person hearing to cross-examine witnesses is not necessary, it is unnecessary to further address CMS’s motion for summary judgment and I proceed by issuing a decision based on the written record.

As neither party objected to any of the proposed exhibits, I admit CMS Exs. 1-15 and P. Exs. 1-2 into the record.

I cite to the regulations found at 42 C.F.R. Part 483 that were in effect at the time of the survey.1

For the reasons set forth below, I find that the facility was not in substantial compliance with the quality of care participation requirements for the prevention and treatment of pressure ulcers and that the penalty imposed is reasonable.2

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I.  Background

The Social Security Act (Act) sets forth requirements for skilled nursing facilities (SNFs) to participate in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to survey SNFs in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. §§ 488.10, 488.20.  Each facility must be surveyed annually, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

An annual recertification survey for Green Village was completed on July 20, 2017, by the Ohio Department of Health (ODH).  The survey found Green Village was out of compliance with twelve participation requirements.  The facility was found to have returned to substantial compliance on September 16, 2017.  Petitioner has appealed only the deficiency cited at 42 C.F.R. § 483.25(b)(1) (F314) (failure to provide necessary treatment and services for a resident having a pressure ulcer), which is alleged to have resulted in serious deterioration of the wound.  CMS determined the resident suffered actual harm, causing the deficiency to be cited at scope and severity level ”G,”3 and imposed a CMP of $1,210 per day from July 17, 2017 through September 15, 2017.  CMS Ex. 2, CMS Ex. 3 at 1-3.4  The total CMP was $73,810.  CMS Ex. 3 at 3.  If the

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final CMP found is $10,483 or more, Green Village will be prohibited from conducting or offering a NATCEP for a two-year period.  42 C.F.R. §§ 483.151(b)(2)(iv) and (f); CMS Ex. 3 at 4-5.

Petitioner disagrees with CMS’s finding that the facility failed to provide necessary treatment of the wound.  Further, the facility denies that there was a significant deterioration of the wound, resulting in actual harm to Resident #128 (R128).  Green Village argues the record provides that the wound, with treatment, steadily improved.

II.  Issues

The issues before me are:

1. Was the facility in substantial compliance with 42 C.F.R. § 483.25(b)(1) (Tag F314 – Treatment/Services to prevent/heal pressure sores);
2. Whether failure to provide treatment resulted in actual harm to R128;
3.  If the facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), is the CMP  of $1,210 per day for 61 days, for a total of $73,810, reasonable; and
4. If the facility is not in substantial compliance, is the CMP $10,483 or more, and, if so, is Green Village prohibited from conducting or offering a NATCEP?

III.  Findings of Fact and Conclusions of Law

A. The facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) because it failed to provide Resident #128 with the necessary care and services to promote healing of her pressure sore .5

CMS contends that Green Village was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(Tag F314) for R128 as it failed to provide necessary treatment for her pressure ulcer as required by that regulation.

CMS relies on 42 C.F.R. § 483.25(b)(1), which provides:

(1) Pressure ulcers.  Based on the comprehensive assessment of a resident, the facility must ensure that –

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(i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable; and

(ii) A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.

Under the statute and the “quality of care” regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a 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); 42 C.F.R. § 483.25.  The Departmental Appeals Board (DAB) has explained that 42 C.F.R. § 483.25 imposes an implicit duty on a facility to provide care and services that, at a minimum, meet accepted “professional standards of quality.”  Spring Meadows Health Care Ctr., DAB No. 1966 at 17 (2005), citing 42 C.F.R. § 483.25.To this end, the DAB has further explained that “[t]o be in substantial compliance, a SNF must ensure, among other requirements, that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual’s clinical condition demonstrates that they were unavoidable, and that a resident with pressure sores receives the necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.”  The Harborage, DAB No. 2905 at 1-2 (2018).6  In assessing the facility’s compliance with this requirement, the relevant question is:  did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent new sores from developing?  If it did so, and the resident develops pressure sores anyway, there is no deficiency.  But if the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation.  Senior Rehab., DAB No. 2300 at 13-14, aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 32 (2000).

The Facility, at the time of the survey, had a Pressure Ulcer Risk and Skin Assessment Policy requiring routine assessment of residents and providing for specific interventions for residents deemed at risk of skin impairment. CMS Ex. 7 at 1.  The policy warned “[i]f pressure ulcers . . . are not treated when discovered, they can quickly enlarge and become very painful for the Resident.  Also, often times they can become infected[.]”  Id.  This

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policy also provided for ongoing skin assessment, monitoring of skin changes, and timely and prompt interventions if a pressure ulcer was found.  Id. at 2.

R128 was admitted to the facility on April 21, 2016, with diagnoses including heart failure, hypertension, hypothyroidism, transient cerebral ischemic attacks, chronic atrial fibrillation, gastro-esophageal reflux disease, malignant melanoma of the skin, muscle weakness, difficultly walking and frequent falls.  CMS Ex. 8 at 1.

According to the record, R128 was hospitalized from May 6 through May 12, 2017.  R128 did not have any pressure ulcers at the time of discharge to the hospital.  On May 12, 2017, when R128 was readmitted to Petitioner’s facility, a skin assessment was completed, and found that R128 had no pressure ulcers.  CMS Ex. 10 at 1.

A Minimum Data Set assessment dated July 9, 2017, revealed that R128 also had a severe cognitive impairment and required extensive assistance for bed mobility, dressing, toilet use, hygiene, and eating.  See CMS Exs. 10 at 1 and 15 at 2.  The resident was noted to always be incontinent of urine and frequently incontinent of bowel.  Id.  The MDS indicated that R128 was at risk of developing pressure ulcers.  Id.

On June 8, 2017, Petitioner’s nursing staff discovered a pressure ulcer on R128’s coccyx.  The ulcer measured 4.0 cm in length, 2.0 cm in width, 0.1 cm in depth, and was classified as stage 1.  CMS Ex. 10 at 2; CMS Ex. 13 at 10-11.  The surveyor indicated that, because there was a depth measurement, such an ulcer should have been classified as a stage 2 ulcer in accordance with the guidelines from the National Pressure Ulcer Advisory Panel (NPUAP).  CMS Exs. 10; 11; and 15 at 3.  When the surveyor interviewed the Acting Director of Nursing (ADON), the ADON agreed the pressure ulcer should have been classified as stage 2 rather than stage 1.  CMS Ex. 10 at 4; CMS Ex. 15 at 4.

On June 8, 2017, a physician wrote orders for R128, instructing the nursing staff to apply DermaSeptin ointment to R128’s coccyx and to cover the ulcer with a foam dressing.  CMS Ex. 8 at 1. The nursing staff was to apply treatment and change the dressing every 72 hours and as needed.  Id.  There was no documentation that any treatment was administered at the time of the physician’s order or anytime during the following 3 days.  Id.

A new physician’s order was written on June 12, 2017, that discontinued the June 8, 2017 order.  The new order instructed the staff to cleanse the wound, apply barrier and border dressings daily and as needed.  CMS Ex. 8 at 6.  Records for R128 reflect this treatment was administered on June 12, 2017.  Id.

On June 13, 2017, R128’s records indicate the pressure ulcer had become unstageable, measuring 3.0 cm in length by 1.0 cm in width.  The depth could not be determined as the ulcer was 80 percent necrotic (dead tissue) and had 20 percent granulation tissue (healthy

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and healing tissue).  CMS Ex. 13 at 29.  In evaluating the condition of the pressure ulcer, the surveyor relied on the NPUAP Guidelines, which indicate an unstageable pressure ulcer involves “full-thickness skin and tissue loss in which the extent of tissue damage . . . cannot be confirmed because it is obscured by slough or eschar.”  The Guidelines state further that if the slough or eschar is removed, a stage 3 or 4 pressure ulcer will be revealed.  CMS Ex. 1 at 17-18; CMS Ex. 11 at 1.

Petitioner argues treatment was provided during the period of June 8 - June 11, 2017.  However, the treatment records for R128 fail to support this argument as does the interview with the ADON.  During the interview with the surveyor on July 18, 2017, the ADON admitted the documentation in the record for R128 was poor and did not show any treatment was administered to R128 between June 8 and June 12, 2017.  The ADON also agreed that R128’s records showed the wound had deteriorated, becoming unstageable as of June 13, 2017.  CMS Ex. 10 at 4; CMS Ex. 15 at 4.7

Beginning June 13, 2017, R128’s records include more extensive wound evaluation documentation.  CMS Ex. 13 at 21-22, 24-25, and 29 (duplicated at 31).  In addition to the information noted above, on June 13, it was stated, among other things, that R128 “was recently admitted . . . with noted red buttocks” and the “[a]rea is now open [with] slough in the wound base.”  CMS Ex. 13 at 29 (duplicated at 31).  A new physician’s order was written on June 14, 2017, which instructed the nursing staff to cleanse the wound with normal saline; apply Santyl, and Adaptic or Xeroform; cover with bordered gauze; and change daily and as needed.  CMS Ex. 8 at 4.  The staff was also to perform frequent repositioning of R128, and make frequent checks and changes to minimize exposure to incontinence.  CMS Ex. 13 at 29 (duplicate at 31).

For the period from June 14 through July 3, 2017, these orders were followed, with the exception of June 22 and June 29, 2017.  CMS Ex. 8 at 4; CMS Ex. 9 at 4.  R128’s records indicate these treatments were performed by the nursing staff and by the wound nurse at the facility.  Id.; CMS Ex. 13 at 21, 22, 27.

The record indicates that once the physician-ordered treatment was begun on June 14, 2017, R128’s pressure ulcer showed improvement, reducing in size and the amount of necrotic tissue.  On July 6, 2017 there was no longer any necrotic tissue.  However, the pressure ulcer was determined to be a stage 3 wound based on the depth of the wound.  CMS Ex. 13 at 24.

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Green Village contends the pressure ulcer was unavoidable as a result of R128’s multiple and severe medical conditions.  P. Request for Hearing.  They also argue the surveyor was in error to rely on the NPUAP Guidelines in finding a worsening of the pressure ulcer.  The facility indicates that the pressure ulcer should not have been rated as worsening, referencing the CMS Resident Assessment Instrument (RAI) Version 3.0 Manual, which states:

If a pressure ulcer was numerically staged and becomes unstageable due to slough or eschar, do not consider this pressure ulcer as worsened.

P. Br. at 3-4 (citing CMS Ex. 13 at 19).

Additionally, the facility argues that once treatment began, R128’s records demonstrate the pressure ulcer showed steady improvement.  However, this argument is refuted by R128’s treatment records.  Those records document that after the treatment of the wound began, the wound still became necrotic and was later determined to be a stage 3 ulcer.

I find it unnecessary to decide whether the wound cited for R128 was unavoidable as Petitioner failed to provide treatment to R128 that its own internal policies and guidelines mandated.  These failures by Petitioner to provide necessary treatment and services to R128 are not consistent with its policy nor with 42 C.F.R. § 483.25(b)(1).  Treatment was not instituted timely for the pressure ulcer, once discovered and as ordered by a physician.  The records for R128 do not reflect the physician’s orders of June 8, 2017 were performed on June 8, 2017, nor were they performed at any time during the following 3 days.  The regulation at 42 C.F.R. § 483.25(b)(1) provides:

(1) Pressure ulcers.  Based on the comprehensive assessment of a resident, the facility must ensure that

(i)  A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates they were unavoidable: and
(ii)  A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.

The facility also did not follow its own Pressure Ulcer Risk and Skin Assessment policy in caring for R128.  That policy indicates “[i]f pressure ulcers are not identified after development or are not treated when discovered, they can quickly enlarge . . . .” CMS Ex. 7 at 1 (emphasis added).

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In the interview with the surveyor, the ADON agreed that the records failed to indicate that any treatment was provided to R128 from the date of the physician’s order, June 8, 2017, until June 12, 2017.  The ADON also agreed that the pressure ulcer had worsened when it became unstageable.  CMS Ex. 10 at 4; CMS Ex. 15 at 4.  Although the facility argues the NPUAP Guidelines should not have been used by the surveyor to determine whether the pressure ulcer had worsened, it is unnecessary to rely on them to determine the condition of the ulcer.  R128’s records reflect that on July 6, 2017, the ulcer was rated stage 3 due to its depth measurement despite showing improvement after treatment had begun.  CMS Ex. 13 at 24.  Thus, the evidence reflects R128’s pressure ulcer worsened before improving.

The evidence of record clearly shows the facility did not promptly take all the necessary precautions to promote healing.  Petitioner did not follow its own policy in the treatment of R128’s pressure ulcer when it failed to provide the treatment ordered by her physician from June 8 through June 11, 2017.  Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 12 (2017); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 32 (2000).

Thus, the evidence of record supports a finding the facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1).  Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 8-10 (2004), aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005).

It is not necessary that I examine Petitioner’s argument that the pressure ulcer was unavoidable since I find that Petitioner’s noncompliance is established based on its failure to provide necessary care and services to treat R128’s pressure sore.

B. Petitioner’s failure to provide ordered treatment resulted in a worsening of the pressure ulcer and actual harm to R128.

I find the Facility was not in compliance with 42 C.F.R. § 483.25(b)(1) and R128’s pressure ulcer worsened due to its noncompliance.  I find that the resident suffered actual harm as she developed a Stage 2 pressure ulcer, which deteriorated to having 80 percent necrotic tissue, and then was later described as a stage 3 ulcer. This conclusion supports a deficiency cited at a scope and severity level “G” for actual harm.

C. The penalty imposed, $1,210 per day for a total of $73,810, is reasonable.

To determine whether a CMP is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort

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or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, an ALJ must sustain the CMP.  Coquina Ctr., DAB No. 1860 at 32 (2002).

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and, in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  Barn Hill Care Ctr.,DAB No. 1848 at 21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1683 at 8 (1999).

Here, the penalty imposed, $1,210 per day for 61 days, for a total of $73,810, is at the lower end of the per-day range of $105 to $6,289 for penalties imposed for non-immediate jeopardy level deficiencies.  42 C.F.R. §§ 488.408(d)(1)(iii), 488.438(a)(1)(ii); 45 C.F.R. § 102.3.  In addition, the facility has a history of noncompliance, including previous deficiency citations involving actual harm in surveys of June 10 and June 28, 2016.  CMS Ex. 4 at 2.

Petitioner does not claim that its financial condition affects its ability to pay and has not submitted any financial documents indicating such payment would cause the facility a hardship should it be required to pay the CMP.

The facility was culpable in its failure to provide the necessary treatment and services to R128, in accordance with the regulations and its own internal policy for the treatment and care of pressure ulcers.  Petitioner’s failures were serious and caused actual harm to R128.  Accordingly, I conclude that the proposed CMP totaling $73,810 is reasonable.

D. The total CMP exceeds $10,483.  As a consequence, Petitioner also loses the authority to conduct or offer a NATCEP for a period of two years.

Under the statute and regulations, the state agency cannot approve Petitioner’s NATCEP if CMS imposes a penalty of $10,483 or more.  Here, I have affirmed the total CMP amount of $73,810, which exceeds the $10,483 threshold amount that triggers loss of NATCEP approval.  Thus, as a consequence, Petitioner is prohibited from conducting a NATCEP for two years.

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IV.  Conclusion

CMS properly determined the facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), and I affirm, as reasonable, the penalty imposed.

• 1. Federal nursing home regulations substantially changed beginning on November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  In addition, CMS revised the F-Tags in November 2017.  However, in this case, both the state agency and CMS referred to the deficiency cited under 42 C.F.R. § 483.25(b)(1) using the F-Tag that was in effect prior to the revision of the regulations.  See List of Revised F-Tags (May 14, 2020), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/List-of-Revised-FTags.pdf.
• 2. Throughout this decision, the terms “pressure ulcers” and “pressure sores” are used interchangeably.
• 3. 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.  As relevant here, a scope and severity level of “G” indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  See State Operations Manual (SOM), Ch. 7, § 7400.3.1 (Rev. 185, effective Nov. 16, 2018) (current version)), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf; see also 42 C.F.R. § 488.408. 
• 4. The per-day CMP ranges applicable to this case are $6,394 to $20,965 for immediate jeopardy-level deficiencies and $105 to $6,289 for deficiencies that do not constitute immediate jeopardy. 82 Fed. Reg. 9174, 9182 (Feb. 3, 2017) (setting 2017 inflation adjustments).  The aforementioned CMP ranges reflect the statutorily mandated amounts and ranges as adjusted for inflation, which were mandated by the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No. 114-74, § 701.  82 Fed. Reg. at 9182; 45 C.F.R. § 102.3.
• 5. My findings of fact and conclusions of law are set forth in bold and italics, as captions in the findings of fact and conclusion of law section of this discussion.
• 6. In its decision, the DAB cited 42 C.F.R. § 483.25(c), which contains identical language to 42 C.F.R. § 483.25(b)(1), and which was the regulation in effect at the time of the survey which provided the basis for CMS’s determination of noncompliance.
• 7. I note that the records for R128 reflect several different locations for the pressure ulcer.  However, in the interview with the surveyor, the ADON confirmed the records show only one pressure ulcer and any references to pressure ulcers in R128’s records all refer to the same pressure wound.  CMS Ex. 10 at 4; CMS Ex. 15 at 4.