Mi Casita LTC Partners, Inc., DAB CR6230 (2023)

DECISION

Mi Casita LTC Partners, Inc., (Petitioner or the facility) is a skilled nursing facility located in Lubbock, Texas.  On January 9, 2019, it was notified by the Centers for Medicare & Medicaid Services (CMS) that, following a survey completed on December 13, 2018, it was found to be out of compliance with participation requirements.  Of significance here is the finding of noncompliance with 42 C.F.R. § 483.25(b)(1)(i)(ii), Federal Tag F0686, governing treatment and services to prevent/heal pressure ulcers.¹  A $10,000 per instance civil money penalty (CMP) was imposed.  CMS Exhibit (Ex.) 1 at 2.  On January 28, 2019, CMS revised the CMP for this violation to $20,965.00.  CMS Ex. 1 at 10.  Petitioner filed a timely request for hearing on March 29, 2019.² See C-19-621. 

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For the reasons discussed below, I find that the facility was not in substantial compliance with the Medicare requirements governing treatment and services to prevent/heal pressure ulcers, as set forth in 42 C.F.R. § 483.25(b)(1)(i)(ii), and I affirm, as reasonable, the imposition of a $20,965.00 CMP. 

I. Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare program, and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing the 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 with program participation requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  The regulations require that each facility be surveyed once every twelve months, and more often, if necessary, to ensure that identified deficiencies are corrected.  42 C.F.R. §§ 488.20(a); 488.308; see also Act § 1819(g)(2)(A).  

In this case, surveyors from the Texas Health and Human Services Commission completed a survey of the facility on December 13, 2018.  CMS Ex. 1.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with the federal requirements for nursing homes participating in the Medicare and Medicaid programs under 42 C.F.R. § 483.25(b)(1)(i)(ii).  Following the timely request for hearing filed by Petitioner, Judge Bill Thomas issued an Acknowledgement and Pre-Hearing Order (APHO) dated April 17, 2019, setting forth prehearing procedures.³

Both parties filed their pre-hearing exchanges, including pre-hearing briefs.  CMS filed a Pre-Hearing Brief (CMS Br.) and 20 proposed exhibits.  Petitioner filed a Pre-Hearing Brief (P. Br.) and 33 proposed exhibits.  

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Both parties filed objections to the other party’s exhibits.  CMS objected to Petitioner (P.) Ex. 5 because it mischaracterized the statement by Sonja Creek, summarizing her conversation with Antonec Jamar Washington.  The Centers for Medicare & Medicaid Services’ Objections to Petitioner’s Exhibits (CMS Obj.) at 1.  CMS is correct that while P. Ex. 5 is identified as a “Statement from Antonec (Jamar) Washington, LVN” in Petitioner’s Pre-Hearing Exchange, it is very apparent from reading the statement that it is not a direct statement from Mr. Washington but instead is a summary of a conversation that Ms. Creek allegedly had with Mr. Washington.  While it is clearly misidentified in the proposed exhibit list, I do not find this to be a basis for excluding it from the record.  The misidentification in the proposed exhibit list is not likely to lead to confusion or uncertainty as to the source of that hearsay statement.  As a result, that objection is overruled.  

CMS also objected to the admission of P. Exhibits (Exs.) 22, 32, and 33 on the basis that, pursuant to an unidentified “Order,” Petitioner “must cite the exhibit number and relevant page number” and it failed to cite these exhibits in its Pre-hearing brief.  CMS Obj. at 1-2.  This objection appears to be based on the APHO from Judge Thomas dated April 17, 2019, which specified that “[i]f a party’s argument relies on a particular exhibit, the party must cite the exhibit number and relevant page number.  I may exclude an argument and evidence that relates to such argument if a party fails to address it in its pre-hearing brief.”⁴ APHO ¶ 5, § c.  I presume CMS’s argument is that Petitioner did not cite these exhibits in its brief and, therefore, they should be excluded.  However, CMS’s objections on this basis are based on an overly expansive reading of the APHO.  Judge Thomas did not say that he would not admit any document that was not cited in a brief, which CMS appears to imply.  Rather, the APHO states that he “may exclude an argument and evidence that relates to such argument if a party fails to address it in its pre-hearing brief.”  Id.  (emphasis added).  In this case, the documents in question were not associated with any specific argument so this objection is overruled. 

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In Petitioner’s Objections to CMS’s Proposed Exhibits (P. Obj.), it objects to CMS Exs. 1, 2, 3, 4, and 5 if they are offered for the purpose of establishing a deficient practice.  Under the provisions of 42 C.F.R. § 498.60(b), I am required to inquire fully into all of the matters at issue and receive into evidence “any documents that are relevant and material.”  This would necessarily include the statement of deficiencies, CMS Ex. 2, which sets out the survey findings on which CMS based its enforcement actions that are the subject of the appeal.  This is “unquestionably relevant and material evidence.”  Avalon Place Trinity, DAB No. 2819 at 38 (2017).  Similarly, the CMS notices in its exhibits are the jurisdictional documents, establishing the right to a hearing and the issues to be addressed.  They are also relevant and material to identifying the survey cycle, cited deficiencies, periods of noncompliance, and remedies imposed.  As such, they are relevant and material.  The weight to be given to the conclusions cited in these documents is determined by the trier of fact.  As a result, I overrule Petitioner’s objections to CMS Exs. 1-5. 

Petitioner objected to the admission of CMS Ex. 8 and CMS Ex. 13, pp. 7-12 because they contain information about other residents.⁵  I concur that CMS Ex. 8 contains private information about other residents, which is not relevant to this proceeding.  While this document does contain some information regarding the type of medication taken by Resident 99, this information is more completely provided elsewhere.  See CMS Ex. 9 at 88-93, 95-96.  As a result, I sustain the objection to CMS Ex. 8.  CMS Ex. 13, however, contains the notes from the surveyor, which correspond to the statement of deficiencies.  Since the notes provide additional background with which to evaluate the statement of deficiencies, they are relevant and material.  Accordingly, Petitioner’s objection to CMS Ex. 13 is overruled. 

Petitioner objected to the admission of CMS Ex. 17, which pertains to other surveys, on the basis of relevance.  However, in determining whether the CMP is reasonable, 42 C.F.R. § 488.438(f)(1) requires consideration of the facility’s history of noncompliance.  Therefore, CMS Ex. 17 is relevant and the objection is overruled.  

Petitioner’s objections to CMS Exs. 18 and 19 are based on the qualifications of the witnesses to make judgments about the issues in this matter.  That objection goes to the weight to be given to these opinions.  Given the lack of argument that these declarations are not relevant and material, the ultimate question for admissibility, the objections to CMS Exs. 18 and 19 are overruled. 

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Finally, Petitioner has objected to CMS Ex. 20, CMS State Operations Manual (SOM) guidelines, on the basis that they are not binding.  I would agree that they are not binding but they represent CMS’s interpretations of the regulations and reflect guidance available to facilities on pressure ulcers.⁶ As such, they are relevant and material and the objection to the admission of this document is overruled. 

Based on the above, CMS Exs. 1-7, CMS Exs. 9 and 10, CMS Ex. 13, and CMS Exs. 15-20; and P. Exs. 1-33 are admitted into the record. 

Both parties submitted the written sworn testimony of proposed witnesses and both parties initially requested to cross examine the other party’s witnesses.  As a result, two hearings were scheduled and then continued at the request of the parties.  A third hearing was scheduled for November 20, 2021.  While noting “dilatory behavior” on the part of both parties, on November 18, 2021, Judge Thomas granted an unopposed motion for a decision on the written record and briefs.  See Order Cancelling Hearing and Granting Petitioner’s Motion for Decision on the Written Record and Briefs.  As a result, this decision is issued in accordance with the provisions of 42 C.F.R. §§ 498.66(b) and 498.74(a). 

II. Issues

The issues are:  

1.  Was the facility in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i) and (ii); and
2. If the facility was not in substantial compliance, is the imposed per instance penalty of $20,965.00 reasonable? 

It is also necessary to delineate the issues in this matter on which there is no right to a hearing.  There is a long and tortuous procedural history here.  The relevant portions are addressed for the purpose of identifying the issues that are and are not before me for adjudication.  As indicated earlier, the initial notice from CMS dated January 9, 2019 found that Petitioner was not in substantial compliance with the Medicare/Medicaid requirements of the following:  

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F0576 -- S/S:  E -- 483.10(g)(6)-(9) -- Right to Forms of Communication with Privacy
F0684 -- S/S:  D -- 483.25 -- Quality of Care
F0686 -- S/S:  G -- 483.25(b)(1)(i)(ii) -- Treatment/Services to Prevent/Heal Pressure Ulcer
F0804 -- S/S:  F -- 483.60(d)(1)(2) -- Nutritive Value/Appear, Palatable/Prefer Temp
F0812 -- S/S:  F -- 483.60(i)(1)(2) -- Food Procurement, Store/Prepare/Serve-Sanitary

483.90(a) Life Safety from Fire
K0352 -- S/S:  F -- NFPA 101 -- Sprinkler System - Supervisory Signals

CMS Ex. 1 at 1.  

The identified enforcement remedies were termination of its Medicare and Medicaid Provider agreement unless the facility achieved substantial compliance before June 13, 2019 and a per instance CMP of $10,000.00.  Id. at 1-2.  On January 28, 2019, the per instance CMP was revised to $20,965.00 for deficiency F0686.  Id. at 10.  Based on a survey completed on January 18, 2019, CMS notified Petitioner that because of continuing noncompliance with section 483.25(b)(1)(i)(ii), the enforcement remedies imposed were termination of its provider agreement, denial of payment for new Medicare/Medicaid admissions, and the $20,965.00 CMP.  Id. at 17.  

On April 4, 2019, Petitioner was notified that the facility had achieved substantial compliance with Medicare requirements on February 21, 2019 and the enforcement actions were revised, as follows:  the termination of Medicare/Medicaid provider agreement was rescinded and the denial of payment for new Medicare and Medicaid admissions was revoked effective February 21, 2019, but the CMP of $20,965.00 remained.  Id. at 25.  On August 2, 2019, CMS rescinded the denial of payment for new Medicare/Medicaid admissions for the period from January 18, 2019 through February 20, 2019.  CMS. Ex. 3 at 1.  As a result, the only remaining penalty is the per instance CMP of $20,965.00 for the noncompliance with 42 C.F.R. § 483.25(b)(1)(i)(ii), based on the inspection completed on December 13, 2018.  Id. 

Petitioner provided extensive argument about the violations stemming from the January 18, 2019 survey.  P. Br. at 9-15.  However, because the remedies associated with that survey were subsequently rescinded, as detailed above, there is no right to a hearing on those remedies and the underlying violations.  The Board has long held that “neither the Act nor the regulations provide a hearing right for a finding of noncompliance absent the imposition of an enforcement remedy specified by the regulations.”  Generations at Regency Ctr. DAB No. 2950 at 6 (2019) (citing San Fernando Post Acute Hosp., DAB No. 2492 at 2, 6-8 (2012) (discussing the appeal rights of facilities that receive a

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determination of noncompliance with Medicare participation requirements)); see also Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (“A [skilled nursing facility] has no right to an ALJ hearing to contest survey deficiency findings where CMS has not imposed any of the remedies specified at section 488.406 based on those findings, or where CMS imposed, but subsequently rescinded, any such remedies.”) (and cases cited therein).  While Petitioner has the right to a hearing on the enforcement action imposed because of the alleged lack of compliance with 42 C.F.R. § 483.25(b)(1)(i)(ii), it does not have a right to a hearing on other violations for which no remedy remains. 

III. Discussion

A.  The record establishes that the facility was not in compliance with 42 C.F.R. § 483.25(b)(1)(i)(ii).⁷ 

42 C.F.R. § 483.25(b)(1), governing pressure ulcers, provides that

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 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. 

These facts are not in dispute.  Resident 99 was admitted to the facility from another nursing home on December 4, 2018, with diagnoses including stress fracture of the right ankle with malunion, type 2 diabetes with diabetic cataract, legal blindness, end stage renal disease on hemodialysis, hypertension, muscle wasting and atrophy, nausea with vomiting, and pressure ulcer of unspecified buttock, stage II.  CMS Ex. 9 at 2-3.  An Admission/Readmission Assessment was conducted at the facility on December 4, 2018.  In the assessment of skin integrity, the color was normal, temperature was cool and dry, there was no bruising, skin tears, abrasions, lacerations, rash, or moisture associated skin damage.  CMS Ex. 9 at 62-78.  An ulcer on the coccyx was noted.  Id. at 71.  That assessment did not specifically identify a cast/splint on the right ankle.  It did note impairment of the lower extremity on one side but described Resident 99 as full weight bearing.  Id. at 73. 

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A Braden Scale for Predicting Pressure Sore Risk was completed on December 4, 2018 and resulted an assessment of low risk.  CMS Ex. 9 at 108-109.  A potential problem was noted to be friction and shear resulting from skin sliding against sheets, chair, restraints, or other devices during moves.  A 48 Hour Baseline Care Plan was also established on December 4, 2018.  Id. at 121-129.  The Baseline Care Plan included the Pressure Sore/Skin at Risk Assessment, which identified the goal of preventing pressure sores, with a history of pressure sore to buttocks but no open areas at the time of admission.⁸  Interventions identified to accomplish this goal were to reposition every 2 hours, encourage being up, frozen nutritional supplements, and safety with transfers and repositioning.  A splint cast for a right ankle stress fracture was also noted during this assessment.  Id. at 126. 

In a Daily Skilled Nursing Note dated December 5, 2018, there was no indication of any abnormal skin conditions, including the presence of a pressure ulcer.  CMS Ex. 9 at 139.  The examiner noted “right ankle wrapped with ace with splint intact.”  Id. at 142.  A Weekly Skin Assessment was conducted on December 6, 2018.  Id. at 116.  Notes of this assessment indicate that there was no “pressure, venous, arterial, or diabetic ulcer” and Resident 99 had a “splint to left ankle wrapped with ace toes were warm to touch.”  Id. at 116 (emphasis added).  An examination during an ER visit on December 7, 2018 for elevated temperature and vomiting included an x-ray showing a posterior cast, and healed fractures of the right ankle.  Id. at 6.  

On December 8, 2018, Sherri Graham, R.N., the Director of Nursing (DON), was cleaning and applying lotion to Resident 99’s leg when she found what she described as a stage 2 pressure ulcer measuring 3.0 x 2.5 x.1 edges.⁹  CMS Ex. 9 at 60.¹⁰  Although the nursing note does not indicate this, the DON stated in her declaration that she removed the splint cast to make this observation.¹¹  P. Ex. 16 at 4.  The pressure ulcer was reported

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to the treating physician on December 8, 2018.  CMS Ex. 9 at 120.  On December 9, 2018, doctor’s orders were received to “[c]leanse right heel ulcer with normal saline, pat dry, apply hydrogel and cover with adhesive foam dressing everyday.  Apply lotion to leg and foot and rewrap splint cast with ace wrap. one time a day.”  CMS Ex. 9 at 9.  In the Weekly Ulcer Assessment dated December 9, 2018, the ulcer was described as a pressure ulcer, stage II, new wound, with open wound bed margins, macerated skin, granulation with pink or beefy red tissue, shiny, moist, and granular, and with light yellow exudate.  CMS Ex. 9 at 118-120.  The ulcer was measured at 3.0 by 2.25 with a depth of .1.  Id.  

On December 10, 2018, Resident 99 was seen by Heather Durham, Nurse Practitioner (NP), who observed breakdown “under her right boot that she was placed in at previous facility.”  P. Ex. 20 at 1.  She reported “right heel with slough noted, stage 2 to buttocks.”  Id. at 2. 

In a Progress Note dated December 11, 2018, Heather Cantu, Licensed Vocational Nurse (LVN), entered a note stating “[c]alled Heather about x rays to resident’s right foot and ankle and about needing a new splint.  She said to make her an appointment with CMC ortho.  Will pass on in report for am nurse to call.”  CMS Ex. 9 at 59.  In her sworn statement, Ms. Cantu indicated that as soon as she received the outside x-rays on December 11, 2018, she contacted the physician’s NP, who advised her to arrange an appointment at the orthopedic clinic for Resident 99.  P. Ex. 19 at 2.  She stated that she passed this information on to the day shift nurse for the following day and it was her “understanding that the day shift arranged for the orthopedic clinic appointment.”  Id.  In identically worded statements, both the DON and Sonja Creek, R.N., Regional Clinical Manager, (RCM) stated that Resident 99 was seen by Heather Durham, the NP for Dr. Skinner, less than 48 hours after the discovery of the heel wounds.  P. Ex. 16 at 4; P. Ex. 18 at 4.  They both indicated that the appointment at the orthopedic clinic was “done within just a few hours,” as reflected in the nurses’ notes.  P. Ex. 16 at 5; P. Ex. 18 at 5.  The two written statements also noted that on December 12, 2018 at 15:07, the DON spoke again with Ms. Durham regarding the heel wounds and had been instructed to apply an air cast until the orthopedic appointment could be completed.  Id.  The nursing note documenting this call indicated that the DON spoke to Ms. Durham “regarding wound to right heel with odor and splint cast with odor.  Order received to do a wound culture and may apply air cast until apt with orthopedist.”¹²  P. Ex. 26 at 4.  The nursing

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note dated December 12, 2018 indicated the call to Covenant Orthopedics to get Resident 99 an appointment to see an Orthopedic doctor was not made until 15:15 by “cbrown33 Nursing-Licensed Vocational Nurse.”  P. Ex. 26 at 4. 

A nursing note dated December 12, 2018 at 16:16 indicated wound care was provided to Resident 99‘s right heel with a “measurement of 6 cm x 3.5 cm.  Black and red in color.  No drainage noted to area.  Wound culture collected and sent to lab.”  P. Ex. 26 at 3-4. 

Other observations of the right heel ulcer were made during the survey.  Kelly Carroll, Registered Nurse (RN), one of the surveyors, indicated that on December 12, 2018 at 2:45 PM, she observed the pressure ulcer on Resident 99’s right foot that “was approximately the size of a dime/nickel.  The cast was soiled on the interior, had dead skin in it, and had a foul odor.”  CMS Ex. 18 at 2.  Sherell Guichard-Thomas, another surveyor, stated that on December 12, 2018 at 2:45 PM, she observed Resident 99’s foot and noted the right heel had a slight foul odor, the wound was the size of a dime/nickel, with white slough, red areas with missing skin, and was moist.  CMS Ex. 19 at 2; CMS Ex. 2 at 22.  The right foot was swollen and dark.  Id.  According to Ms. Guichard-Thomas, “the hard, molded splint cast that had been taken off of the resident’s right foot was heavily soiled and had a foul odor to it.  The interior of this brace was heavily soiled with brown residue.”  Id. 

On December 13, 2018, Surveyor Guichard-Thomas observed Resident 99’s right heel.  CMS Ex. 2 at 29.  She described a stage 2 pressure ulcer to the right heel, where the tissue looked red and beefy. 

There were no further facility records describing the condition of the right heel pressure ulcer following the December 13, 2018 survey.  On December 15, 2018, Resident 99 was sent to the ER from the Dialysis Center because of a blood pressure reading of 230/93 and a heart rate of 57 bpm and was admitted for dialysis.  CMS Ex. 10 at 30, 36.  She was hospitalized for dialysis on December 17, 2018 to improve her blood pressure.  CMS Ex. 10 at 36.  During the hospitalization, she was seen for assessment of the right ankle fracture and chronic wound.  CMS Ex. 10 at 22.  While x-rays were inconclusive, magnetic resonance imaging showed a nonhealing right ankle fracture.  Sepsis secondary to an infected tunneled right internal jugular catheter for dialysis was diagnosed and treated with antibiotics.  When initially admitted, early breakdown of the skin of the heel, as well as the anterior aspect of the ankle and shin was observed.  CMS Ex. 10 at 18. 

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Wound care was attempted and an offloading boot was used but she continued to have breakdown of the skin.  Id.  Because of continued pressure despite the offloading boot and what was described as significant microvascular and peripheral vascular disease secondary to the renal failure, the wound progressed from a dry eschar to a wet gangrene and soft tissue necrosis.  CMS Ex. 10 at 17 and 18.  As a result, a below the knee amputation of the right leg was performed on January 8, 2019.  Id.  

There is no dispute that, on December 8, 2018, the DON discovered what she described as a stage 2 pressure ulcer.¹³  CMS Ex. 9 at 60.  CMS found the facility was in violation of section 483.25(b)(1)(i)(ii) because of the failure to prevent/heal a pressure ulcer.  CMS Ex. 1 at 17.  The Board has long held that a prima facie case of noncompliance exists when the evidence establishes that a nursing home resident having no pressure sores on admission develops a pressure sore in the facility.  Koester Pavilion, DAB No. 1750 at 34 (2000).  Once CMS has established its prima facie case, the facility would then bear the burden of showing that the development or deterioration of pressure sores was “clinically unavoidable.”  Clermont Nursing and Convalescent Ctr., DAB No. 1923 at 9 (2004).  Moreover, if the resident already has pressure ulcers on admission, the facility must ensure that he/she receives the treatment and services necessary to promote healing, prevent infection, and prevent new ulcers from developing.  As the Board stated, in such cases, the issue is not whether the pressure ulcer could be expected to heal but, rather, whether facility staff was providing the necessary care and services to promote healing.  Fireside Lodge Ret. Ctr., DAB No 2794 at 12 (2017).  If the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation.  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. HHS, No. 10-60241 (Dec. 20, 2010); Koester at 32.  

Petitioner begins by arguing that there was no evidence to confirm that the heel ulcer developed at the facility.  P. Br. at 6-7.  The DON stated it was her professional opinion that the facility “did not cause Resident 99’s heel wounds, and there is not even any evidence that these wounds developed at MiCasita.”  P. Ex. 16 at 5.  The RCM provided an identically worded opinion.  P. Ex. 18 at 5.  I would agree that there is no evidence to establish when the pressure ulcer developed.¹⁴  Because the cast/splint was not removed until December 8, 2018, there was no inspection of the skin on the right heel from

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December 4, 2018 through December 8, 2018.  The condition of the skin on the right heel at the time of admission is, therefore, unknown.¹⁵ 

However, whether the pressure ulcer was present at the time of admission on December 4, 2018 or whether it developed at the facility after admission makes no difference in the facility’s obligations under section 483.25(b).  In addition to the obligation to prevent an ulcer from developing, it is also obligated to care for an existing ulcer.  42 C.F.R. § 483.25(b)(1)(ii) requires the facility to provide “necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.”  If, in fact, Resident 99 had entered the facility with a preexisting right heel ulcer on December 4, 2018, no evaluation or treatment of that ulcer was provided until December 8, 2018.  Failure to discover and treat an ulcer that was present at the time of admission is no less culpable than failing to prevent an ulcer from developing after admission.  By the time the right heel pressure ulcer was discovered and wound treatment was initiated on December 8, 2018, the right heel ulcer was described as stage 2, “measuring 3.0 x 2.5 x .1 edges to medial of wound is stage 1 for total of 5cm.”  CMS Ex. 9 at 60.  By December 12, 2018, the pressure ulcer was described as “6 cm x 3.5cm.  Black and red in color.  No drainage noted to area.”  P. Ex. 26 at 3-4.  During the survey on December 12, 2018 the pressure ulcer was observed to be approximately the size of a dime/nickel with a foul odor.  CMS Ex. 18 at 2.  Similarly, Sherell Guichard-Thomas, the surveyor, described her observations on December 12, 2018 during the survey, noting that the wound on Resident 99’s right heel had a slight foul odor, was approximately the size of a dime/nickel, had white slough, was moist, and had red areas with missing skin.  CMS Ex. 19 at 2.  The right foot was noted to be swollen and dark and the splint that had been removed was “heavily soiled” with brown residue and had a foul odor.  Id. 

There are only two possibilities here.  Either the pressure ulcer developed at the facility or an existing pressure ulcer went untreated for four days until the “heavily soiled” and foul smelling cast was removed.  As a result, regardless of whether the right heel pressure ulcer was present at the time of admission or developed after admission on December 4, 2018, CMS has established a prima facie case of noncompliance with 42 C.F.R. § 483.25(b)(1)(i)(ii) with the failure to either prevent pressure ulcers or provide necessary treatment and services to promote healing of pressure ulcers.  The burden then shifts to

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Petitioner to establish, by a preponderance of the evidence, that it was in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)(ii). 

Petitioner makes several arguments as to why there was no violation.  It initially argues

“The lead in language of section 483.25(b)(1) plainly states that the requirement to prevent pressure ulcers is based on the “comprehensive assessment” of the resident.  The “comprehensive assessment” referenced in the federal regulations is the MDS, or Minimum Data Set.  It is undisputed that the MDS is not due to be completed until after the resident has been in the facility for 14 days.” 

P. Br. at 2.  It then asserts that because Resident 99 had not been in the facility for 14 days, no comprehensive assessment was due.  P. Br. at 3.  In essence, it alleges that the provisions of section 483.25(b) are not applicable until after the comprehensive assessment has been conducted. 

Petitioner is correct that 42 C.F.R. § 483.25(b)(1) requires the facility to ensure care, treatment, and services “[b]ased on the comprehensive assessment of a resident.”  However, such a narrow interpretation fails to consider the overall quality of care requirements of section 483.25.  Quality of care, the principle described in the lead-in language of section 483.25, requires a facility to ensure that each resident receives treatment and care based on the resident’s comprehensive assessment and “in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices. . . .” Surely, it would not be consistent with professional standards of practice to fail to provide any evaluation for or treatment of pressure ulcers for 14 days, until the comprehensive assessment was conducted.  Such an interpretation of section 483.25(b) is inconsistent with the requirement in section 1819(b) of the Social Security Act, which provides that a skilled nursing facility “must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident” and “must provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.” 

It is significant that Petitioner has not cited any support for its very conservative interpretation of this regulation.  The Board has certainly not adopted such a narrow reading of section 483.25.  It has repeatedly held that the requirements under section 483.25 “obligate the [facility] to furnish the care and services set forth in a resident’s care plan, to implement doctors’ orders, to monitor and document the resident’s condition, and . . . to follow its own resident care policies.”  Good Shepherd Home for the Aged, Inc. d/b/a The Good Shepherd Home, DAB No. 2858 at 12 (2018) (citing Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012) (citing cases), aff’d, 535 F. App’x 468 (6th Cir.

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2013)); see also Woodland Village Nursing Ctr., DAB No. 2053 at 9 (2006) (citing cases), aff’d, 239 F. App’x 80 (5th Cir. 2007). 

In this case, the facility’s Admissions Policy covering “newly admitted residents” includes the obligation to “[o]bserve the general condition of the resident (i.e., rashes, burns, bruises, sores, etc. . .).”  CMS Ex. 15 at 1.  Similarly, the facility’s Pressure Ulcer Protocols and Prevention policy requires that “[d]uring the admission nursing assessment process, the condition of the resident’s skin should be noted.”  CMS Ex. 16 at 2.  The policy statement also notes that the “[p]revention of pressure ulcers from forming is a priority when caring for residents.”  Id.  Nowhere in these facility policy statements does it indicate that these provisions may be delayed for 14 days or until the comprehensive assessment has been conducted.  Thus, Petitioner’s argument is not consistent with its own resident care policies, much less its regulatory obligation to provide quality of care.  Accordingly, I do not find Petitioner’s argument on this issue to be persuasive. 

The narrow but determinative question in this case is whether, consistent with professional standards of practice, the facility should have removed Resident 99’s cast/splint at the time of her admission on December 4, 2018 to either inspect the skin under the cast/splint for ulcers or treat the ulcer if it existed at that time.  Kelly Carroll, RN, part of the survey team, stated in her declaration that “[i]f the facility had removed the “removable” cast during the head to toe admission skin assessment the facility would have found the condition of the resident’s heel.  The facility could have performed a skin assessment under the removable case even after the initial assessment and if they had, they would have seen the skin breakdown.”  CMS Ex. 18 at 2.  Sherell Guichard-Thomas, another surveyor, stated in her declaration that “[i]f her current facility had removed the removable case immediately upon admission, they could have assessed her skin and immediately put into place measures and treatments to prevent pressure sore development.”  CMS Ex. 19 at 2.  These opinions were consistent with the guidance in the SOM excerpt governing pressure ulcers.  CMS Ex. 20.  That section indicates that an admission evaluation helps identify residents at risk of developing pressure ulcers and residents with existing ulcers, which then helps define those initial care approaches.  Id. at 6.  That guidance further noted that pressure ulcers may develop from pressure “caused by tubes, casts, orthotics, braces, cervical collars, or other medical devices.”  Id. at 9.  Under this guidance, the presence of the splint on the right leg on admission suggested a risk of developing a pressure ulcer and attention should have been paid to the skin under the splint at the time of admission.  Because of the consistency between the assessment guidance in the SOM and the opinions in CMS Exs. 18 and 19, those opinions are given great weight. 

Petitioner counters these statements by arguing that there were no physician orders to allow or require the facility staff to remove the splint/cast, it would have been inappropriate for any of the LVN’s to remove the splint/cast, and Resident 99’s family had instructed the LVN not to remove the splint/cast until she was seen by the physician

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or nurse practitioner.  P. Br. at 4-5.  The DON reiterated these arguments in her written statement.  P. Ex. 16.  She indicated that, in the absence of a physician’s order, “it would not have been appropriate for any of the LVN’s to remove the splint/cast without the physician’s approval” because it was outside the LVN’s scope of practice and could have caused more harm to the resident in light of the non-union of the fracture.  P. Ex. 16 at 3.  The DON indicated that the facility’s plan was to wait for the physician/NP to personally examine and provide treatment orders for the resident, which would occur within the first few days.  Id.  In nearly identical language, the RCM makes the same arguments.  P. Ex. 18 at 3. 

Considering first the doctor’s orders or lack thereof, there is no indication that any physician sent an order indicating the splint could not be removed.  Admission orders related to the right ankle fracture were limited to checking for pain every shift.  CMS Ex. 9 at 12.  More significantly, the facility subsequently did remove the splint without any change in physician orders and before Resident 99 was seen by either the physician or the nurse practitioner.  It was only after the splint/cast was removed by the DON and the pressure ulcer on the right heel was discovered that the physician and NP were notified.  CMS Ex. 9 at 120; P. Ex. 20 at 1.  As a result, the lack of a physician’s order to remove the splint is not persuasive evidence to justify the failure to inspect the skin of Resident 99’s right heel on admission. 

I will accept Petitioner’s argument that it would not be appropriate for an LVN to remove the splint.  However, since the splint was subsequently removed by the DON, an RN, there is no apparent reason why this could not have been done at the time of admission to assess the skin under the splint. 

Finally, while there is nothing in the record other than the hearsay statements from the LVN that Resident 99’s family did not want the splint removed until she was seen by the doctor or NP, P. Ex. 16 at 3; CMS Ex. 19 at 3, I will also accept those statements at face value. However, that reported opposition did not prevent the DON from removing the splint on December 8, 2018, without any apparent communication with the family.¹⁶  Thus, these arguments for not removing the splint to assess the skin at the time of admission are not persuasive. 

Petitioner next essentially argues that it is not appropriate to apply the provisions of section 483.25(b) to the ulcer identified during the December 13, 2018 survey because it was not a pressure ulcer.  Petitioner asserts that “the heel ulcers were not even pressure ulcers, but were chronic vascular ulcers which were never going to heal, despite the most

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aggressive care the hospital could provide.”  P. Br. at 7.  The DON in her written statement also indicated that “as it turned out, the wounds were not true pressure ulcers, but rather vascular lesions caused by ischemic necrosis, or tissue destruction resulting from poor circulation/blood flow.”  P. Ex. 16 at 6.  Ms. Creek provided an identically worded statement.  P. Ex. 18 at 6.  Petitioner cites as support for this argument “F686 surveyor interpretative guidelines” and the “National Pressure Ulcer Council,” which reportedly indicate that “if a resident suffers from a chronic vascular ulcer (resulting from poor circulation), a pressure ulcer deficiency is not proper.”  P. Br. at 7.  It then asserts that because Resident 99’s circulation was “extensively impaired” this “led directly to the development of non-healing vascular wounds.”  Id. 

I have carefully considered this argument put forth by Petitioner but cannot give weight to these retroactive recharacterizations of the diagnosis of a pressure ulcer on the right heel on December 8, 2018 because the objective record does not support the statements that the wound on the right heel was a vascular ulcer which would never heal.  

While Petitioner cites the surveyor interpretive guidelines as authority for this position, a more complete reading of those guidelines does not provide support for this argument.  The interpretative guidance for F0686 does indicate that there are several kinds of skin injuries, including pressure, vascular insufficiency/ischemia, and neuropathic.  CMS Ex. 20 at 15.  However, that guidance further indicates that at the time of the assessment, clinicians should “document the clinical basis” for “any determination that an injury is not pressure related.”  Id.  In this case, there is no such documentation at the time of the initial assessment or any time after that.  The diagnosis of and treatment for a pressure ulcer remained unchanged during the relevant period at the facility and during the subsequent hospitalization. 

The DON herself made the diagnosis of stage 2 pressure ulcer on December 8, 2018, when she removed the splint on the right leg and discovered the right heel ulcer.  CMS Ex. 9 at 60.  Nowhere in the facility records was there any documentation of the clinical basis for identifying the wound as anything other than a pressure ulcer, as required by the interpretative guidance cited above.  During the Weekly Ulcer Assessment dated December 9, 2018, the “Type of Ulcer” was identified as “Pressure,” stage II.  CMS Ex. 9 at 118.  Moreover, when hospitalized for hypertensive crisis on December 17, 2018, diagnoses included “Pressure ulcer of the right foot, present on admission.”  CMS Ex. 10 at 21.  At no point did any of the physicians or other treating sources during this hospitalization recharacterize the wound on the right heel as something other than a pressure ulcer.¹⁷  Nor was there any indication in any treatment record that the right heel

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wound was anything other than a pressure ulcer.  While the vascular disease may have contributed to the delayed healing, there is no objective evidence to establish that the ulcer did not result from pressure on the right heel from the splint.  Even at the time of the amputation, the surgeon indicated that “she has had continued pressure on this despite the pressure offloading boot.”  CMS Ex. 10 at 18. 

Moreover, if, in fact, Resident 99’s circulation was so “extensively impaired, which led directly to the development of non-healing vascular wounds,” as asserted by Petitioner, it is impossible to reconcile the reported healing of other wounds she developed.¹⁸ P. Br. at 7.  There was some evidence of initial healing in the right heel pressure ulcer, with the DON observing “granulation tissue (which generally reflects an ability to heal)” on December 8, 2018.  P. Ex. 16 at 4.  Granulation tissue was also reported on a Weekly Ulcer Assessment dated December 9, 2018.  CMS Ex. 9 at 118.  In identically worded footnotes, the DON and RCM confirmed that the coccyx ulcer identified on December 4, 2018 “was healed at the time she was admitted to the hospital and was still healed (covered with scar tissue, which is common for healed pressure areas) when she was admitted.”  P. Ex. 16 at 8; P. Ex. 18 at 8; CMS Ex. 9 at 71.  In a note dated January 22, 2019, Heather Durham, NP, stated she changed the diagnosis from Stage II to the coccyx to acute dermatitis because it healed in two days with treatment.  P. Ex. 1 (emphasis added). 

Given the above objective evidence, the post-survey recharacterization of the right heel pressure ulcer by Petitioner’s witnesses is not given weight. 

The preceding discussion is not to suggest that the facility did nothing to prevent pressure ulcers.  The baseline care plan included a turning and repositioning program and frozen nutritional supplements.  CMS Ex. 9 at 126.  The DON and the RCM, again in identical statements, indicated that the baseline care plan also included the use of a specialty pressure relieving mattress and the use of pillows for positioning to prevent ulcers.  P. Ex. 16 at 2; P. Ex. 18 at 2.  Although review of the baseline care plan contained in CMS Ex. 9 at 121-129 does not reference the specialty mattress and pillows, I accept the statements that they were provided as part of the ulcer prevention program.  Notwithstanding these services, the facility did not inspect the skin on Resident 99’s right heel under the removable splint for four days after she was admitted, resulting in the lack of either prevention or treatment of the pressure ulcer that was diagnosed on December 8, 2018. 

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Accordingly, Petitioner has not established, by a preponderance of evidence, that it was in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)(ii). 

B.  The penalty imposed is reasonable. 

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

CMS has imposed just one $20,965.00 per instance CMP, which is in the high end of the penalty range for per instance penalties ($2,140-$21,393).  42 C.F.R. §§ 488.408(d)(1)(iv), 488.438(a)(2); 45 C.F.R. § 102.3 (2018); 83 Fed. Reg. at 51,380.  Given the serious outcome in this case, however, this amount is not unreasonable. 

Petitioner has a history of noncompliance, including a pattern of noncompliance and previous deficiencies under F0686.  CMS Ex. 17 at 3; 42 C.F.R. § 488.438(f)(1).  There have been no previous immediate jeopardy findings, however. 

Petitioner does not claim that its financial condition affects its ability to pay this amount. 

Petitioner argues that it did not commit any deficient practice and, even if it did “it has shown that its actions did not result in any resident harm.”  P. Br. at 15.  However, as discussed extensively above, the development of or lack of treatment of the right heel pressure ulcer certainly did result in actual harm to Resident 99.  Because of the failure to evaluate the skin under the right heel or, alternately, to treat the existing pressure ulcer, Resident 99 spent four days in a splint described as “heavily soiled with brown residue” with a “foul odor” and an open wound on the skin.  CMS Ex. 19 at 2.  One wonders how Petitioner would define “actual harm” if the development of or lack of treatment for a pressure ulcer on Resident 99’s right heel, with horrendous subsequent complications, is not deemed to be harm to a resident.  The facility was culpable in its failure to either prevent or treat the right heel pressure ulcer during the period from December 4, 2018 through December 8, 2018, which caused her actual harm.

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Petitioner also asserts that the increase in the CMP by CMS from $10,000 to $20,965.00 was “without any justification or basis.”  P. Br. at 15.¹⁹  However, the question before me is not whether CMS had a basis for increasing the CMP but whether the existing CMP is reasonable.  42 C.F.R. § 488.438(e) explicitly states that the administrative law judge “may not” review the exercise of discretion by CMS to impose a CMP.  Moreover, the Board has consistently reinforced this regulatory provision, holding in Emerald Oaks, DAB No. 1800 at 11 (2001) that the ALJ is not “to make any finding concerning how CMS exercised its discretion in selecting a remedy or setting the amount of a penalty,” but rather to take evidence on any contested issue relating to the factors supporting the reasonableness of the amount of any CMP imposed.  See also Cal Turner Extended Care Pavilion, DAB No. 2030 at 7-8 (2006).  

For the above reasons, I find that the proposed CMP in the amount of $20,965.00 is reasonable.  

IV.  Conclusion

For the reasons discussed above, I find that the facility was not in substantial compliance with the Medicare requirements governing treatment and services to prevent/heal pressure ulcers, pursuant to the provisions of 42 C.F.R. § 483.25(b)(1)(i)(ii).  The $20,965.00 per instance penalty imposed is reasonable. 

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Endnotes

¹  There were multiple other deficiencies cited in this notice with numerous subsequent modifications, as discussed in the procedural history, but they are not relevant to this adjudication.

²  In response to subsequent inspections and CMS notices, additional requests for hearing were filed on April 8, 2019 and April 30, 2019, with associated Docket numbers C-19-651 and C-19-748. These cases were consolidated under Docket number C-19-748 in Orders from Judge Thomas dated April 25, 2019 and May 8, 2019.

³  The case was originally assigned to Judge Thomas but was later reassigned to me on November 25, 2022.

⁴  I would note that Petitioner did not comply with other provisions of the APHO issued by Judge Thomas. In that same paragraph, Petitioner was directed not to submit duplicate copies of documents already submitted by CMS. Petitioner submitted a plethora of duplicate documents, such as P. Ex. 9, which is a duplicate of CMS Ex. 10 at 25; P. Ex. 25, which is a duplicate of CMS Ex. 9, pp. 118 to 120; P. Ex. 29, which is a duplicate of CMS Ex. 9, pp. 11-17; P. Ex. 22, which is a duplicate of CMS Ex. 16; and P. Ex. 30, which is a duplicate of CMS Ex. 9, pp. 62-78. Petitioner perhaps characterizes its exhibits as new rather than duplicates because some of them contain yellow highlighting that was added by an unknown source. Because the highlighting does nothing to change the document, I do consider these to be duplicates of documents already in the file. (There is also a presumption in the highlighting that the reader is incapable of determining what is significant in the document, which is not appreciated by this reader). However, since the duplication of records has not resulted in anything more than a waste of time and was not objected to by CMS, they will be admitted.

⁵  Ironically, Petitioner itself submitted records containing personal information about other residents of the facility. P. Ex. 28. However, CMS has not filed any objection to this proposed exhibit. Petitioner also did not object to the admission of CMS Ex. 10, p. 14, which also contains the names of other residents. As a result, these documents remain in the record.

⁶  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  State of Indiana by the Indiana Department of Public Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Center v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations, as interpreted by the SOM. 

⁷  My findings of fact and conclusion of law are set forth in bold and italic text in the discussion captions of this decision.

⁸  While the regulation refers to pressure ulcers, some records and documents refer to the wounds as pressure sores. While there are an “array of terms used to describe alterations in skin integrity due to pressure,” the decision uses the regulatory term. CMS Ex. 20 at 2.

⁹  There is a discrepancy between the nursing notes and the DON’s declaration as to the initial observation of the wound. In her declaration, she reported she “discovered two small ulcers measuring a combined total of 5 cm.” P. Ex. 16 at 4.

¹⁰  Although the Progress Note for this encounter is dated December 9, 2018, it is identified as a late entry, with the services performed at 20:30, presumably on December 8, 2018.

¹¹  The declaration of the DON is drafted partially in the third person so it is not entirely clear whether another person was involved in this examination. It states that “[a]s I was applying lotion to Resident 99’s legs, she noticed the resident’s toes looked very flaky, so she decided to remove the bandages and dressing. When I did, I discovered two small ulcers.” P. Ex. 16 at 4. It is presumed that this is a matter of inartful drafting of a statement by a third party for the DON, rather than the presence of a second individual working in tandem with the DON.

¹²  It is not clear that the air cast recommended by the nurse practitioner on December 12, 2018 was ever applied. P. Ex. 26 at 4. When seen at the ER on December 15, 2018, admission physical examination noted “Splint to the right ankle.” CMS Ex. 10 at 31. Dr. Gunnell, the foot surgeon, stated that upon admission to the hospital on December 17, 2018, Resident 99 was observed to have “been placed into a splint and was in a posterior splint. She initially presented to our hospital, was removed from the splint.” CMS Ex. 10 at 18.

¹³  Petitioner’s subsequent denial that this was a pressure ulcer is addressed below.

¹⁴  This, however, provides no support for the conclusion that the pressure ulcer on the right heel didn’t develop at the facility, as discussed below.  As a result, the opinions on causation provided by the DON and the RCM are not given any weight. 

¹⁵  There are some indications that Resident 99 did not enter the facility with a pressure ulcer on the right heel. The admission diagnoses on December 4, 2018 include a pressure ulcer on the buttock but do not include any diagnosis of a right heel pressure ulcer. CMS Ex. 9 at 3. Moreover, the earlier records from Williamsburg, the facility from which Resident 99 was transferred, do not include the diagnosis of a right heel ulcer. CMS Ex. 9 at 29-55.

¹⁶  Even assuming the family was insistent on the splint not being removed, the Board has stated that a “facility should accommodate the family’s preferences as much as possible, but must still take necessary measures to prevent the predictable consequences of pressure sores.” Koester, DAB No. 1750 at 34.

¹⁷  In their statements that the right heel wound was not a pressure ulcer and would never heal, Petitioner’s witnesses also do not address the other sources of infection that were documented at the time of the hospitalization on December 17, 2018. On admission, Resident 99 was diagnosed with hemodialysis catheter associated line sepsis, secondary to Enterobacter cloacae, and Bacteremia, requiring IV antibiotic treatment and removal of the line. CMS Ex. 10 at 20, 22-23. Thus, there were many sources of possible infections present at the time of the amputation, which may have affected the healing process.

¹⁸  I am going to assume that the reference in the Hospitalist Discharge Summary dated January 7, 2019 to “right foot ulcer that is now healed” is simply incredibly bad drafting. CMS Ex. 10 at 25. Amputating the foot could hardly be viewed as healing the ulcer.

¹⁹  Although not relevant, as discussed above, it is interesting that the CMP was increased after the subsequent survey on January 19, 2019, which included records documenting the amputation of the right leg below the knee, suggesting that this may have been a factor in CMS’s revised CMP. See CMS Ex. 10, which contains records from Covenant Medical Center, each with a date stamp of January 18, 2019.