Vibra Hospital of Charleston - TCU, DAB No. 3094 (2023)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Vibra Hospital of Charleston - TCU (Vibra), a South Carolina skilled nursing facility, appealed the decision of an administrative law judge (ALJ) upholding on summary judgment the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Vibra for noncompliance with multiple Medicare participation requirements in connection with an unauthorized body cavity search of a facility resident.  Vibra Hospital of Charleston - TCU, DAB CR5091 (2018) (ALJ Decision).  The ALJ concluded that:  (i) Vibra was not in substantial compliance with Medicare participation requirements regarding resident abuse, anti-abuse policies, professional standards of care,  facility administration, and quality assurance from July 27, 2015 through January 18, 2016; (ii) CMS’s determination that Vibra’s noncompliance posed immediate jeopardy to resident health and safety from July 27 through December 15, 2015 was not clearly erroneous; and (iii) the civil money penalties (CMPs) imposed against Vibra – $7,000 per day for the period of immediate jeopardy, and $200 per day for noncompliance following abatement of immediate jeopardy – were reasonable.  Based on our de novo review of the record, we affirm the decision to grant summary judgment in favor of CMS but for reasons different from those set out in the ALJ Decision.   

Legal Background

To participate in the Medicare program, a skilled nursing facility must be in “substantial compliance” with the requirements in 42 C.F.R. Part 483, Subpart B (§§ 483.1 - 483.95).  42 C.F.R. §§ 483.1(b), 488.400.¹  A skilled nursing facility is not in “substantial compliance” when it has a “deficiency” – that is, a failure to meet a participation

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requirement – that creates the potential for more than minimal harm to one or more residents.  Id. § 488.301 (defining “substantial compliance” and “deficiency”).  The term “noncompliance,” as used in the applicable regulations, is synonymous with lack of substantial compliance.  Id. (defining “noncompliance”).  The participation requirements at issue in this appeal include the following:

• “The resident has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion.”  42 C.F.R. § 483.13(b).
• “The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents . . . .  The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse . . . are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency).”  Id. § 483.13(c)(2).
• “The services provided or arranged by the facility must . . . [m]eet professional standards of quality.”  Id. § 483.20(k)(3)(i).
• “A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.”  Id. § 483.75.
• “A facility must maintain a quality assessment and assurance committee . . . [that] [m]eets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary; and … [d]evelops and implements appropriate plans of action to correct identified quality deficiencies.”  Id. § 483.75(o)(1), (2)(i)-(ii).

Compliance with Medicare participation requirements is verified through onsite surveys performed by state health agencies.  Id. §§ 488.10, 488.11(a).  A state agency reports any “deficiency” it finds in a Statement of Deficiencies.  Id. § 488.325(f)(1).²  A Statement of

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Deficiencies also indicates the survey agency’s assessment of the “seriousness” of any cited deficiency.  Id.§ 488.404(a).  Seriousness is a function of the scope of noncompliance (whether a deficiency is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether a deficiency has created a “potential for” only “minimal harm” or a potential for “more than minimal harm,” resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  Id.§ 488.404(b).  The most severe deficiency is that which puts one or more residents in “immediate jeopardy.”  See id. § 488.438(a) (authorizing the highest per-day CMPs for immediate-jeopardy-level noncompliance); Woodland Oaks Healthcare Facility, DAB No. 2355, at 2 (2010) (citing authorities).  “Immediate jeopardy” means “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

CMS may impose one or more remedies on a skilled nursing facility that is found to be out of substantial compliance.  Id. §§ 488.400, 488.402(b)-(c), 488.406.  The remedies that CMS may impose for noncompliance include CMPs.  Id. §§ 488.406, 488.430.  A per-day CMP may be imposed for “the number of days a facility is not in substantial compliance with one or more participation requirements.”  Id. § 488.430(a).  If CMS imposes a per-day CMP for immediate-jeopardy-level noncompliance, it must set the CMP amount within the “upper range” of $3,050 to $10,000 per day.  Id. § 488.438(a)(1)(i).  A CMP in the “lower range” range of $50 to $3,000 per day may be imposed for noncompliance that does not place residents in “immediate jeopardy” but that either causes actual harm or creates the potential for more than minimal harm.  Id. § 488.438(a)(1)(ii). 

A skilled nursing facility may challenge a determination of noncompliance that led to the imposition of a remedy by requesting an ALJ hearing and appealing any unfavorable ALJ decision to the Board.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(b)-(c).

Case Background

The facts in this section are undisputed unless otherwise noted.

Vibra Hospital of Charleston is a long-term acute care hospital (LTACH) located in South Carolina.  Vibra operates a skilled nursing facility at the same location called the Transitional Care Unit (TCU).  Resident 1 (R1), age 64, was admitted to the Vibra LTACH on April 30, 2015, for recuperation for a broken hip with total hip arthroplasty.  CMS Ex. 6, at 1.  Prior to admission, R1 had fallen and dislocated a hip prosthesis (which was revised) and developed an infection.  Id.  On May 26, 2015, R1 was transferred to the Vibra TCU skilled nursing facility for further treatment and recuperation.  CMS Ex. 7.  In addition to the hip fracture, R1 was also diagnosed with various illnesses, including COPD, hypertension, PTSD, anxiety, osteoporosis, anemia, alcohol abuse, and sacral decubitus ulcer.  Id. at 2; CMS Ex. 6, at 1-2; CMS Ex. 4, at 6.

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On July 23, 2015, after discussions with staff, Vibra’s medical director, John Kleckley, M.D., issued a telephone order requiring a search of R1’s room for alcohol and cigarettes every shift.  CMS Ex. 7, at 168; P. Ex. 2 (Kleckley Decl.), at 3 (¶ 13).  Subsequently, on July 25, 2015, while searching R1’s room, nursing staff found a large bottle of vodka and an electronic cigarette (e-cigarette) after a friend had visited R1.  CMS Ex. 7, at 34.  During the search, R1 became belligerent and verbally abusive towards staff.  Id.  A further search of the room on that same day resulted in the discovery of several other empty wine and vodka bottles.  Id.  R1 denied drinking any liquor and stated that the items belonged to R1’s friend.  Id. 

The following day, more e-cigarettes, empty e-cigarette packages, and a large empty vodka bottle were discovered in R1’s room.  Id. at 34.  Again, R1 became belligerent and verbally abusive towards staff during the search.  Id.  One nurse noted, however, that R1 did not show any signs of intoxication or appear to have recently consumed any alcohol.  Id.  As of July 26, 2015, R1’s care plan indicated that every shift R1’s room was to be searched for alcohol and cigarettes.  Id. at 14.  At some point the following day, July 27, this directive was changed to “perform a room and body audit” every shift.  Id. at 14-15.

At the morning staff meeting on July 27, 2015, the staff discussed R1 and the alcohol bottles and e-cigarettes that were continuing to be found hidden in R1’s room.  CMS Ex. 28, at 4 (¶ 15); CMS Ex. 11, at 14-15.  The meeting was attended by, among others, the Administrator, interim Director of Nursing (DON), charge nurse on duty, social worker, activity director, and therapy director.  CMS Ex. 11, at 14-15.  The interim DON in attendance at the meeting, JB, told the police that someone at the meeting had questioned whether R1 might have items “inside her.”  Id. at 15.  The activity director, TF, admitted to police that while “brainstorming” at the staff meeting TF had questioned whether R1 might be hiding items in R1’s genital area.  Id. at 33-35.  The therapy director, OM, confirmed to the police that the activity director had “suggested a possible cavity search” (meaning perineal area) during the staff meeting.  Id. at 31-32.

After the morning meeting, the Administrator, interim DON, and charge nurse entered R1’s room to search the room and bed.  CMS Exs. 12, 13, 14.  The charge nurse stated that during the search she placed her hands on R1, who was lying in bed, to keep R1 from hitting or scratching the interim DON.  CMS Ex. 14, at 1.  After searching the room and bed, the Administrator and charge nurse placed themselves on either side of R1’s bed, and the interim DON stood at the foot of the bed.  Id.  The Administrator then inserted her finger into R1’s vagina to search for “contraband.”  CMS Exs. 12, 13, 14; CMS Ex. 11, at 2.  The interim DON said she placed her hands on R1’s left knee to stabilize it during the vaginal search.  CMS Ex. 11, at 16, 20.  Finding nothing, the Administrator withdrew her finger.  CMS Ex. 13.  According to the charge nurse, R1 yelled, “What did you do?”  CMS Ex. 14, at 1.  The interim DON confirmed that R1 shouted, “Get your hand out of my vagina bitch.”  CMS Ex. 11, at 16.  Neither the interim DON nor charge nurse did anything or said anything to stop the Administrator from conducting this

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unauthorized body cavity search.  Vibra’s Chief Executive Officer (CEO) acknowledged in a statement to the police that the vaginal search violated facility policies and that no doctor’s order had been given to conduct such a search.  CMS Ex. 11, at 1-2.

Staff members outside of R1’s room plainly heard R1 protesting loudly at the time of the incident.  CMS Ex. 11, at 23-24 (a nurse, who was in the next room, told the police about hearing R1 yell, “Get your hand out of my vagina you bitch.”); id. at 29 (a nurse assistant told police she heard R1 yell, “Get your hands off of me” and “I can’t believe you just stuck your hands in my vagina.”); id. at 31 (the therapy director told the police about hearing R1 yell, “They’re in my vagina!”).  Despite hearing R1’s protests, no evidence in the record indicates any of these staff members made further inquiries or reported the incident to Vibra’s management.

The following morning, the interim DON told a nurse practitioner about the vaginal search of R1.  CMS Ex. 11, at 26.  The interim DON told the nurse practitioner that staff thought R1 may have been “hiding an e-cigarette inside of her vagina” and that R1 “was yelling during the vaginal exam.”  Id.  Later that afternoon, during a routine medical visit, the nurse practitioner spoke to R1 who confirmed that the Administrator had conducted a body cavity search which upset the resident.  Id. at 26-27 (recounting that R1 reported “she was not doing well after what happened”).  The nurse practitioner then reported the incident to Dr. Kleckley, noting that staff “don’t do vaginal exams” and what was described is “not standard practice.”  Id. at 27.  The nurse practitioner spoke to Dr. Kleckley about the incident on the evening of July 28.  Id.  Dr. Kleckley immediately contacted Vibra’s CEO to report the incident.  CMS Ex. 15; P. Ex. 2, at 2 (¶ 5).  

On July 29, 2015, at 6:40 pm – more than two days after the incident and a full
day after learning of it – Vibra’s CEO faxed a report of alleged abuse to the South Carolina Department of Health and Environmental Control (state agency).  CMS Ex. 8.  The report states that staff had found e-cigarettes and alcohol in R1’s room and, due to safety concerns, “a routine search of the resident’s room & person was done according to Vibra policy.”  Id. (emphasis added).  The report states that R1, who had “a history of threats & false allegations,” reported an assault during the search “despite having 3 witnesses.”  Id.  Without mentioning the body cavity search or the nature of the alleged abuse, the report concluded:  “Investigation in progress.”  Id.  In the meantime, the three employees involved in the body cavity search were not immediately suspended or removed from all patient care responsibilities.  See CMS Ex. 30, at 1.   

On July 29, after learning of the incident from the nurse practitioner, a social worker interviewed R1 and helped R1 prepare a grievance, which the CEO received on July 30.  CMS Ex. 5, at 14; CMS Ex. 10.  In the interview with the social worker, R1 stated that “she is afraid to go to sleep as the director could do it again.”  CMS Ex. 10, at 2.  Also, on July 29, the social worker spoke to twenty-one other residents, reading them various definitions of abuse and neglect and asking whether it had happened to them while at the

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facility.  P. Ex. 5.  The residents who were interviewed answered no, although one resident declined to be interviewed.  Id. at 15. 

According to the facility’s records, Vibra staff received in-service training regarding resident abuse and reporting on July 29 and July 30, 2015.  CMS Ex. 23, at 1-3.  At that time, staff were instructed:  “[I]t is important that you report any allegations of abuse immediately to the Social Worker, Administrator, Director of Nursing or C.E.O. of the building as soon as you are made aware of it.”  Id. at 1-2.  Thus, in the immediate aftermath of the abuse of R1, staff were directed to report resident abuse to the Administrator and interim DON who carried out the abuse of R1.  Id. 

On July 31, four days after the incident, Vibra suspended the Administrator, the interim DON, and the charge nurse who perpetrated the abuse of R1.  CMS Ex. 30, at 1.  The facility terminated their employment effective August 3.  Request for Review (RR) at 23.  Also, on July 31, Vibra notified the police of the incident.  CMS Ex. 30, at 1.  The police investigated, but no criminal charges were filed.  CMS Ex. 11, at 5. 

On August 3, the CEO sent the state agency a follow-up report.  CMS Ex. 9.  This time, the CEO acknowledged that, on July 28, Dr. Kleckley had reported that the search of the resident’s room and person included “a search of the resident’s vagina.”  Id.  The report states that the search was conducted “due to previous instances of alcohol bottles and e-cigarettes being found in the resident’s room.”  Id.  The CEO reported that R1 sustained no physical injury and that Vibra suspended the three staff members “pending the outcome of all investigations.”  Id.  The report also states that the CEO asked for investigations by the South Carolina boards that license nurses and nursing home administrators, that the CEO had reported the incident to the police, and that the police investigation was “ongoing.”  Id.

Vibra hired a new DON (RF) on August 11, 2015.  CMS Ex. 30, at 2.  A new interim Administrator (RK) was hired on September 2, 2015, began work on September 14, 2015, and served as interim Administrator until November 23, 2015.  CMS Ex. 16 (¶ 7); CMS Ex. 30, at 2.  The DON (RF) assumed the role of Administrator on November 24, 2015.  CMS Ex. 30, at 2.³  Effective September 28, 2015, Vibra fired the CEO, specifying that the CEO would not be eligible for rehire.  CMS Ex. 25; CMS Ex. 30, at 1.

At the time of R1’s abuse, Vibra had a Quality Assessment and Assurance (QAA) committee known as the Quality Assurance and Performance Improvement (QAPI) committee.  CMS Ex. 18; CMS Ex. 28, at 5 (¶ 20).  According to Vibra’s “Performance Improvement” policy, dated March 5, 2008, the QAPI committee consisted of the

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Administrator, DON, a physician, and at least three other staff members.  CMS Ex. 18, at 1.  The committee was to meet at least monthly and was responsible for analyzing negative outcomes, identifying root causes which lead to quality deficiencies, developing action plans to correct deficiencies, and implementing and monitoring the action plans.  Id. at 1-2.  At the time of the survey, Vibra could not locate any committee meeting minutes for July, August, or September 2015.  CMS Ex. 4, at 37-38; CMS Ex. 28, at 5 (¶ 20).  After the survey, two pages of handwritten notes were produced and purported to be the committee meeting notes for August and September 2015; however, these notes did not reflect that the committee reviewed the abuse of R1 or formed an action plan in response to the abuse of R1.  CMS Ex. 28, at 5 (¶ 20); CMS Ex. 21. 

The typed minutes for the October 2015 meeting are the first indication that the QAPI committee addressed the issue of R1’s abuse.  CMS Ex. 28, at 5 (¶ 21); CMS Ex. 20.  The “New Business” section reflects that on October 1, 2015, the interim Administrator (RK) presented information about an allegation of abuse that occurred on July 27, 2015, and, with members present, “reviewed the Abuse policy and procedures[,] and QAPI members recommended to retrain staff again on Vibra TCU Abuse policy and procedures.”  CMS Ex. 20, at 1.

From December 9-16, 2015, the state agency conducted a complaint investigation and extended survey to determine whether Vibra was compliant with Medicare participation requirements.  CMS Ex. 1 (Imposition Notice); CMS Ex. 4 (Statement of Deficiencies).  The investigation and survey largely focused on the abuse of R1 and Vibra’s subsequent handling of the incident.  See generally CMS Ex. 4.  The state agency determined Vibra was not in substantial compliance with multiple participation requirements and, on December 15, notified Vibra that conditions at the facility posed immediate jeopardy to the facility’s residents.  CMS Ex. 4, at 1.     

While the survey was ongoing and in response to the immediate jeopardy determination, Vibra formulated a plan, referred to as an Allegation of Compliance (AOC), to abate the immediate jeopardy.  CMS Ex. 30 (AOC).  Vibra submitted the AOC to the state agency on December 16, 2015.  CMS Ex. 4, at 3.  The AOC recounted the steps Vibra took after learning about the abuse of R1, including the social worker’s interview of all residents for complaints or concerns of abuse on July 29, in-service training of staff on July 29-30, the suspension of the employees involved in the abuse on July 31, and notification of the police on July 31.  CMS Ex. 30, at 1.  The AOC reflected that Vibra made the decision to terminate the three employees involved in the abuse on August 2, sent a follow-up report to the state agency on August 3, hired a new DON on August 11, hired a new Administrator on September 12, and terminated the CEO on September 28.  Id. at 1-2. 

During the survey, Vibra also revised its QAPI and QAA policies, issuing new policies and procedures on December 15 and December 16, 2015.  CMS Ex. 19; CMS Ex. 28, at 6-7 (¶ 26).  The new policies included the designation of a QAPI Coordinator (Quality

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Assurance Coordinator), and development of a Medical QAPI committee that meets quarterly and a facility QAPI committee that meets monthly.  CMS Ex. 19, at 1; CMS Ex. 28, at 6-7 (¶ 26).  According to the AOC, Vibra designated its Administrator (RF) to be the new Abuse and Neglect Coordinator on December 15, 2015.  CMS Ex. 30, at 1; see also CMS Ex. 28, at 6 (¶ 26).  The state agency subsequently determined that, based on its “[o]bservations, interviews, and review of policy,” the AOC “had been implemented” and found the immediate jeopardy condition had been removed as of December 16, 2015.  CMS Ex. 4, at 5.

On or about December 22, 2015, the state agency issued a Statement of Deficiencies (SOD) to Vibra summarizing its survey findings.  CMS Exs. 1, 4.  The SOD indicated Vibra was not in substantial compliance with multiple participation requirements, and that noncompliance with some requirements had constituted immediate jeopardy.  CMS Exs. 1, 4.  On January 11, 2016, CMS issued an imposition notice, imposing a CMP of $7,000 per day for the duration of immediate jeopardy (July 27, 2015 through December 15, 2015) and then $200 per day effective December 16, 2015, until Vibra achieved substantial compliance.  CMS Ex. 1, at 2.⁴

Vibra subsequently submitted a Plan of Correction (POC) outlining the steps it would take to achieve substantial compliance.  CMS Ex. 4.⁵  Among other things, Vibra indicated that it would identify on a monthly basis all residents most at risk for abuse and would take additional steps to ensure their safety.  Id. at 6-7.  Vibra also designated a Director of Quality Management to monitor implementation of the POC and to oversee the QAPI committee, and new Quality Assurance Coordinator.  Id. at 9, 17, 38.  Additionally, the Quality Assurance Coordinator would be designated to lead the QAPI committee, and along with the Regional CEO, ensure the QAPI committee “addresses all the areas relevant to this plan of correction.”  Id. at 38, 40.  Vibra designated January 19, 2016, as the completion date for its POC.  Id. at 5-9, 13-17, 19-26, 31-40.  A revisit survey was conducted on January 20, 2016, and based on that revisit, CMS determined that Petitioner returned to substantial compliance on January 19, 2016.  CMS Ex. 2.

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ALJ Proceedings and Decision

Vibra filed a request for hearing disputing the bases for imposing the remedies, as well as the amount and duration of the CMPs.  Vibra appealed only the deficiencies at the immediate jeopardy level and, therefore, the following five deficiencies were at issue before the ALJ:

• 42 C.F.R. § 483.13(b) (Tag F223);
• 42 C.F.R. § 483.13(c) (Tag F226);
• 42 C.F.R. § 483.20(k)(3)(i) (Tag F281);
• 42 C.F.R. § 483.75 (Tag F490);
• 42 C.F.R. § 483.75(o)(1) (Tag F520).

CMS Ex. 4, at 5-24, 25-31, 36-41.⁶  Each party filed pre-hearing submissions, including a brief, witness list, and proposed exhibits.  CMS submitted 33 exhibits (CMS Exs. 1-33).  Vibra submitted 12 exhibits (P. Exs. 1-12).

In an Order dated December 21, 2017, the ALJ noted that, based on the parties’ submissions, “it appears that no material facts are in dispute and that summary judgment may be appropriate.”  Order (12/21/17), at 2.  The ALJ set forth a list of material facts determined to be undisputed (with accompanying exhibits) and directed the parties to “address the question of whether summary judgment is appropriate.”  Id. at 3-4.⁷  In response, Vibra agreed that the summary of facts with accompanying exhibits set forth in the Order are “generally inclusive of the information material to this appeal” and that “ultimately it is the legal import of the facts underlying the investigation and subsequent penalty determinations that are relevant to the outcome.”  Vibra Correspondence (2/1/18) at 1.  CMS agreed that no material facts are in dispute and filed a motion for summary judgment.  CMS Motion for Summary Judgment (MSJ) (2/5/18).  Vibra argued in opposition to CMS’s motion that the undisputed facts establish that the “deficiencies challenged herein should be reversed and/or, in the alternative, the scope and duration of

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the penalties imposed, as well as the amount, are clearly erroneous and subject to substantial reduction.”  Pet.’s Opp’n to MSJ (3/1/18) at 1.

The ALJ found no material facts in dispute and granted summary judgment in favor of CMS.  ALJ Decision at 2.  The ALJ found that:  from July 27, 2015, through January 18, 2016, the facility was not in substantial compliance with 42 C.F.R. §§ 483.13(b), 483.13(c), 483.20(k)(3)(i), 483.75, and 483.75(o)(1); from July 27 through December 15, 2015, those deficiencies posed immediate jeopardy to resident health and safety; and the CMPs imposed are reasonable.  Id.  Thus, the ALJ upheld a CMP of $7,000 per day for 142 days of immediate jeopardy, and $200 per day for 34 days of noncompliance that was not immediate jeopardy.  Id. at 1-2, 4.

Standard of Review

We review whether summary judgment is appropriate de novo.  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703, at 5 (2016).  “Summary judgment is appropriate when the record shows there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.”  Id. (internal quotation marks omitted).  A dispute of fact is “material” if its resolution might affect the case’s outcome under governing law.  Id. (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)).⁸

In evaluating a party’s motion for summary judgment, we view the record in the light most favorable to the non-moving party and giving that party the benefit of all reasonable inferences.  See id.; Pearsall Nursing & Rehab. Ctr. – North, DAB No. 2692, at 5 (2016); Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).  Further, “it is appropriate for the tribunal to consider whether a rational trier of fact could regard the parties’ presentations as sufficient to meet their evidentiary burdens under the relevant substantive law.”  Dumas Nursing & Rehab., L.P., DAB No. 2347, at 5 (2010) (citing Anderson, 477 U.S. at 255 (“[I]n ruling on a motion for summary judgment, the judge must view the evidence presented through the prism of the substantive evidentiary burden.”)); Wade Pediatrics, DAB No. 2153, at 17 n.7 (2008) (“While the non-moving party does not have to prove its case to avoid summary judgment, the evidentiary burdens borne by the parties under the applicable substantive law are a factor in evaluating whether a rational trier of fact could find in favor of the non-moving party.”), aff’d, 567

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F.3d 1202 (10th Cir. 2009).  Moreover, drawing factual inferences in the light most favorable to the non-moving party does not require that a reviewer draw unreasonable inferences or accept the non-moving party’s legal conclusions.  Brightview Care Ctr., DAB No. 2132, at 10 (2007); Cedar Lake Nursing Home, DAB No. 2344, at 7 (2010).  The adjudicator may not make credibility determinations or weigh the evidence when deciding a summary judgment motion.  See Anderson, 477 U.S. at 249, 255.

Analysis

In its Request for Review (RR), Vibra challenges the entry of summary judgment in favor of CMS.  Vibra asserts that the ALJ erred in finding that:  (i) CMS’s determination as to the duration of noncompliance and immediate jeopardy are consistent with statutory and regulatory requirements; (ii) the CMPs imposed are reasonable; (iii) the undisputed evidence established the facility was not administered in the manner required by 42 C.F.R. § 483.75; and (iv) the undisputed evidence established the facility was not in substantial compliance with 42 C.F.R. §§ 483.13(b), (c), and 483.20(k)(3)(1).  RR at 1-2.⁹  Vibra asks the Board to “reverse and vacate” the ALJ’s findings and conclusions and eliminate or reduce the penalties imposed.  Id. at 27.

We address Vibra’s arguments in detail below.  We conclude that the ALJ did not err in granting summary judgment for CMS because (i) the undisputed material facts establish that Vibra was not in substantial compliance with multiple Medicare participation requirements in connection with the unauthorized body cavity search of a resident by the facility’s administrator and staff; (ii) Vibra presented no evidence that could lead a rational trier of fact to conclude that CMS’s immediate jeopardy determination is clearly erroneous or that it returned to substantial compliance earlier than the date determined by CMS; and (iii) the per-day CMP amounts imposed by CMS are reasonable.  Accordingly, based on our de novo review of the record, we affirm the decision to grant summary judgment in favor of CMS for the reasons set forth below.

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I.        The undisputed material facts establish that Vibra was not in substantial compliance with multiple Medicare participation requirements in connection with the unauthorized body cavity search of a resident by the facility’s administrator and staff.

A.       The undisputed material facts establish that Vibra was not in substantial compliance with 42 C.F.R. § 483.13(b) (F223).

A skilled nursing facility must ensure, among other things, that its residents are “free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion.”  42 C.F.R. § 483.13(b).  “Abuse means the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish.”  Id. § 488.301.  There is no serious question that Vibra failed to ensure that R1 was free from abuse when R1 was subjected to an unauthorized body cavity search by the former Administrator who, with the assistance of the interim DON and charge nurse, inserted her finger into the resident’s vagina during a “search” for suspected “contraband.”  CMS Ex. 4, at 5-9; see also supra at 4-5.  

For its part, Vibra does not deny that the unauthorized body cavity search of R1 amounted to resident abuse, violated the facility’s abuse prevention policies, and failed to comply with professional standards of quality.  RR at 5 (“The body cavity search conducted on July 27, 2015 by the former Administrator with the assistance of the Interim DON and CN [charge nurse] was in direct violation of Vibra’s policies and procedures and far exceeded the scope of the administrator’s employment duties and professional licensure.”), 17 (“Vibra has never asserted that abuse did not take place or that no investigation was required.”).  Thus, Vibra does not challenge the ALJ’s determination that the unauthorized body cavity search of R1 amounted to resident abuse in violation of section 483.13(b).  ALJ Decision at 5, 11-12; see also RR at 23-26 (addressing reporting requirements and other matters immaterial to section 483.13(b)).  Accordingly, we affirm the ALJ’s determination that Vibra was not in substantial compliance with section 483.13(b) beginning on July 27, 2015.

B.       The undisputed material facts establish that Vibra was not in substantial compliance with 42 C.F.R. § 483.13(c) (F226).

Section 483.13(c) requires skilled nursing facilities to “develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents . . . .”  42 C.F.R. § 483.13(c) (emphasis added).  Among other requirements, facilities “must ensure that all alleged violations involving mistreatment, neglect, or abuse . . . are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency).”  Id. § 483.13(c)(2).  The South Carolina Omnibus Adult Protection Act – the state law applicable to Vibra – requires that facility nurses and staff

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report abuse of a vulnerable adult to the state agency within 24 hours or the next working day.  See S.C. Code Ann. § 43-35-25 (1976) (amended 2006); see also id. § 43-35-10 (defining vulnerable adult to include “a resident of a facility”).

Vibra had a lengthy written anti-abuse policy that strictly prohibited verbal, sexual, physical, and mental abuse, corporal punishment, and other mistreatment or neglect of residents.  CMS Ex. 17, at 1.  This prohibition applied to all facility staff, residents, and others who interact with residents.  Id.  The policy further recognized that residents with “[p]sychosocial, interactive, and/or behavioral dysfunction” are among those most at risk for abuse and must be identified as such.  Id. at 1, 2.  To protect these vulnerable residents, staff must develop care plans that identify their needs.  Id. at 3. 

The policy further called for staff to receive orientation and ongoing training on:  “[a]ppropriate interventions to deal with aggressive . . . reactions of residents”; “[h]ow to report their knowledge related to [abuse or neglect] allegation[s]”; “[h]ow to recognize signs of burnout, frustration and stress that may lead to abuse [by staff]”; and “[w]hat constitutes abuse . . .”  Id. at 2.  If a staff member suspects physical abuse, they are to “[d]iffuse the situation, and remove the aggressor from all resident contact.”  Id. at 3.  All abuse allegations must be reported to the “CEO, CCO [Chief Clinical Officer], DQM [Director of Quality Management], and the Corp. Director on Skilled Nursing,” and to the appropriate state agencies in accordance with state law.  Id. at 4. 

The policy further required a thorough investigation of any abuse allegation, including a root cause determination.  Id. at 4, 5-6.  The policy mandated that residents be protected during such investigations.  Id. at 5.  Accordingly, a staff member implicated in the abuse of a resident must be immediately removed from any resident contact, interviewed, and suspended pending the results of the investigation.  Id.  “Immediately,” as defined in the policy, means “as soon as possible, but not later than 24 hours.”  Id. at 8 (internal quotation marks omitted).

The Board has long held that a facility is not in substantial compliance with section 483.13(c) when it fails to follow or carry out its own anti-abuse policies.  See, e.g., 38-40 Freneau Ave. Operating Co. LLC, DAB No. 3008, at 2, 8 (2020) (collecting cases); Beverly Health Care Lumberton, DAB No. 2156, at 12-13 (2008) (upholding finding that a facility was not in substantial compliance with its obligation to implement anti-abuse policy because it allowed an employee suspected of abuse to continue working and because employees who witnessed the alleged abuse failed to comply with the policy’s reporting directive), aff’d, 338 F. App’x 307 (4th Cir. 2009).  Here, the undisputed evidence established that Vibra’s staff (at every level) violated the facility’s anti-abuse policy in failing to prevent, report, and appropriately respond to the abuse of R1.  For the reasons explained below, we affirm the ALJ’s determination that Vibra was not in

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substantial compliance with section 483.13(c) beginning on July 27, 2015.¹⁰

It is undisputed that two nurses (the interim DON and charge nurse) did nothing to stop the abuse of R1 by the facility’s Administrator.  See supra at 4-5.  Rather than diffuse the situation and remove the Administrator from all resident contact, as required by Vibra’s policy, these nurses assisted the Administrator in carrying out the abuse.  Id.; see also ALJ Decision at 14 (“[T]he facility’s most crucial employee for preventing and investigating abuse [the Administrator] was herself the abuser.  She was assisted by the DON and a charge nurse.  And not one of these key players seemed to recognize their actions as abusive.”).  In a statement to the police, Vibra’s CEO acknowledged that the vaginal search of R1 violated facility policies.  CMS Ex. 11, at 1-2.   

While the interim DON told a nurse practitioner about the abuse the following day, neither the interim DON nor the charge nurse complied with their obligation under Vibra’s policy to report the abuse to the facility’s CEO, CCO, DQM, and the Corp. Director on Skilled Nursing, and neither nurse reported the abuse to the appropriate state agency in accordance with state law.  See supra at 5.  Still further, three other Vibra employees – a nurse (TW), a nurse assistant (KG), and therapy director (OM) – told the police that they had heard R1 yelling and shouting about being abused on the morning of July 27, yet they did not intervene to stop the abuse, did not report the incident as suspected abuse, and made no inquiries about what they had heard.  See CMS Ex. 11, at 23-24, 29, 31; see also ALJ Decision at 14 (“When staff subsequently heard R1’s protests, they did not intervene to protect her; they did not report the abuse.”).

Moreover, after Vibra’s CEO learned about the abuse of R1 from Dr. Kleckley on the evening of Tuesday, July 28, the CEO did not immediately remove the three employees implicated in the abuse from having any resident contact or suspend them pending the investigation as required by Vibra policy.  CMS Ex. 17, at 5; CMS Ex. 4, at 13.  Instead, the CEO allowed the employees to continue working at the facility until the end of the week (Friday, July 31) and instructed them only to have no further contact with R1.  CMS Ex. 30, at 1; RR at 6.  Allowing three employees suspected of resident abuse to continue working at the facility pending an abuse investigation (and to potentially have contact with other residents) plainly violated Vibra’s anti-abuse policy and further established Vibra’s noncompliance with section 483.13(c).  See Beverly Health Care

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Lumberton, DAB No. 2156, at 13; see also ALJ Decision at 12-13 (“[T]he facility all but ignored its policies for protecting residents while an abuse investigation is pending.  The three employees continued working for four days following the incident.”).   

In its Request for Review, Vibra does not dispute the facts establishing the foregoing noncompliance with section 483.13(c).  RR at 23-25 (focusing on other noncompliance determinations made by the ALJ).  Instead, Vibra seizes on the ALJ’s determination that the CEO’s initial report to the state agency (CMS Ex. 8) on July 29, 2015, was “impermissibly delayed” and “misleading.”  RR at 24 (citing ALJ Decision at 12, 15, 17).  Vibra argues, among other things, that neither CMS nor the state agency raised any concern about the timeliness or content of that initial report during the survey or in the proceedings before the ALJ.  RR at 24.  We agree and, therefore, do not rely on the alleged inadequacy of the CEO’s initial report in affirming summary judgment because that inadequacy was neither found by the state agency in the SOD, nor alleged by CMS in its summary judgment motion, as a basis for noncompliance with section 483.13(c).  Cf. Golden Living Ctr. - Superior, DAB No. 2768, at 8 n.4 (2017) (“CMS may defend a non-compliance determination based on facts, evidence, or reasoning not specified in the Statement of Deficiencies, provided, of course, that due process requirements – adequate notice and a meaningful opportunity to be heard – are satisfied.”). 

Regarding the failure of Vibra’s staff to immediately report the abuse of R1, Vibra asserts that section 483.13(c) does not require a report within 24 hours and further contends that its policy did not require abuse to be reported “immediately.”  RR at 24-25.¹¹  This argument has no merit.  Section 483.13(c) plainly requires the facility to “ensure” that abuse be “reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures.”  42 C.F.R. § 483.13(c)(2) (emphasis added).  Vibra’s policy similarly required that abuse be reported to “the appropriate state agencies in accordance with state law.”  CMS Ex. 17, at 4 (italics added).  Under South Carolina law, facility nurses and staff are required to report abuse of a vulnerable adult (i.e., any facility resident) to the state agency within 24 hours or the next working day.  See S.C. Code Ann. § 43-35-25 (1976) (as amended 2006); see also id. § 43-35-10 (defining vulnerable adult to include a “resident of a facility”).  As recounted above, members of Vibra’s staff, including its interim DON and charge nurse, failed to comply with this mandatory directive by failing to report the July 27 abuse of R1 to the appropriate state agency within 24 hours (or at all).  See supra at 14.  Moreover, those same staff members failed to internally report the abuse of R1 to the CEO, CCO, DQM, and the Corp. Director on Skilled Nursing as required by Vibra’s policy.  Id.

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Vibra further complains that the ALJ erred by finding that the social worker referred R1’s grievance (CMS Ex. 10) to the Administrator because it was only signed “received” by the CEO.  RR at 26 (citing ALJ Decision at 13 n.8).  We agree that the grievance was marked “received” by the CEO, but it also indicates that it was “referred” to the Administrator.  CMS Ex. 10, at 1-3 (indicating that the “Department Referred To” included the “Administrator”).  Whether or not the Administrator, in fact, received the grievance is immaterial.  The ALJ’s point is that the social worker’s referral of the resident’s grievance to both the CEO and the abuser reflects a “disturbing disregard for the resident’s safety.”  ALJ Decision at 13 n.8.  Moreover, there is no dispute Vibra violated its own anti-abuse policy by not immediately removing the Administrator (and the other two employees involved in the abuse) from all resident contact and by allowing them to continue working at the facility while the abuse investigation was pending. 

C.       The undisputed material facts establish that Vibra was not in substantial compliance with 42 C.F.R. § 483.20(k)(3)(i) (F281).

The services provided by a skilled nursing facility must meet “professional standards of quality.”  42 C.F.R. § 483.20(k)(3)(i).  The same undisputed facts that support the finding of resident abuse also support the determination that Vibra failed to provide services meeting “professional standards of quality.”  ALJ Decision at 5, 11.  Vibra was out of substantial compliance with section 483.20(k)(3)(i) based on the “unauthorized vaginal search” performed by the former Administrator, with the assistance of the interim DON and charge nurse.  CMS Ex. 4, at 19-20. 

The Medical Director reported during the survey that pelvic examinations are performed by physicians, not nurses (CMS Ex. 4, at 8), and the interim DON admitted to the police she had no training in conducting a vaginal search because nurses do not perform pelvic examinations (CMS Ex. 11, at 17).  The surveyor, a registered nurse with substantial experience working in skilled nursing facilities, stated that it is extremely rare for pelvic exams to be performed on nursing home residents and, even then, they are performed only for medical reasons.  CMS Ex. 28, at 3 (¶ 14).  The surveyor further explained that “[c]onducting a body cavity search on a nursing home resident is a gross deviation from professional nursing standards,” and that the interim DON and charge nurse also failed to comply with professional standards when they “did not immediately stop the Administrator” from conducting the vaginal search.  Id. at 3-4 (¶ 15).  Vibra does not contest any of this evidence. 

Vibra does not assert (nor could it) that the unauthorized body cavity search of R1 complied with professional standards of quality.  In its Request for Review, Vibra concedes that the unauthorized body cavity search “far exceeded the scope of the administrator’s employment duties and professional licensure.”  RR at 5.  Vibra does not challenge the ALJ’s determination that it was not in substantial compliance with section 483.20(k)(3)(i) based on the unauthorized body cavity search of R1.  ALJ Decision at 11;

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see also RR at 23-26.  Accordingly, we affirm the ALJ’s determination that Vibra was noncompliant with section 483.20(k)(3)(i) beginning on July 27, 2015.

D.       The undisputed material facts establish that Vibra was not in substantial compliance with 42 C.F.R. § 483.75 (F490).

A skilled nursing facility “must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.”  42 C.F.R. § 483.75.  “The central focus of section 483.75 is facility administration,” specifically “how a facility manages, oversees, operates, and executes various functional areas as detailed in the regulation.”  See Avalon Place Trinity, DAB No. 2819, at 31 (2017), aff’d, 761 F. App’x 407 (5th Cir. 2019).  In other words, “the facility must be administered in such a way as to enable it to deliver quality care and services so that residents can ‘attain or maintain the highest practicable physical, mental, and psycho-social well-being.’”  Id.  The Board has long held that a determination of noncompliance with section 483.75 may be derived from findings of noncompliance with other participation requirements.  See Countryside Rehab. & Health Ctr., DAB No. 2853, at 23 (2018) (citing Life Care Ctr. of Tullahoma, DAB No. 2304, at 45 (2010)); see also Pinehurst Healthcare & Rehab. Ctr., DAB No. 2246, at 19-20 (2009) (affirming noncompliance finding under section 483.75 based on facility’s failure to implement its abuse policy and noting the administrator’s role in failing to implement that policy).

The state agency found Vibra was noncompliant with section 483.75 by failing to administer the facility in a manner to protect residents from abuse and cross-referenced the deficiency findings under Tags F223, F226, F281, and F520.  CMS Ex. 4, at 25-31.  The ALJ found these deficiencies (at the immediate jeopardy level) justified a derivative finding that the facility was not in substantial compliance with section 483.75.  ALJ Decision at 15.  The ALJ did not err in concluding that Vibra’s noncompliance with other participation requirements at the immediate jeopardy level (as discussed below) would, by itself, establish Vibra’s noncompliance with 42 C.F.R. § 483.75.  See Life Care Ctr. of Bardstown, DAB No. 2479, at 29 (2012) (explaining that facility’s noncompliance with participation requirements at the immediate jeopardy level “would alone support a finding that [the facility] was out of substantial compliance with the facility administration requirement”), aff’d, 535 F. App’x 468 (6th Cir. 2013).  Moreover, in this case, it was the facility Administrator who abused R1 with the assistance of the interim DON and charge nurse.  Thus, the administration, acting through its supervisory employees, QAPI Committee, and former CEO, failed to protect a vulnerable resident from abuse (F223), failed to follow its abuse prevention policy (F226), failed to provide services meeting professional standards of quality (F281), and (as discussed below) failed to implement an effective and comprehensive corrective action plan (F520).  Based on these uncontroverted facts, we conclude that no rational trier of fact could find that Vibra was in substantial compliance with section 483.75.

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On appeal, Vibra argues that its case is “factually dissimilar” to the cases cited by the ALJ finding noncompliance with section 483.75 on a derivative basis because those cases involved the death of a resident or “very serious injuries” or “the most serious and painful” pressure sores.  RR at 20-21 (discussing Asbury Ctr. at Johnson City, DAB No. 1815 (2002), aff’d, 77 F. App’x 853 (6th Cir. 2003); Odd Fellow & Rebekah Health Care Facility, DAB No. 1839 (2002); and Stone Cnty. Nursing & Rehab. Ctr., DAB No. 2276 (2009)).  None of these cases hold that noncompliance under section 483.75 turns on the death of a resident or the level of actual harm caused to a resident.  We further reject the suggestion that an unauthorized body cavity search of a resident by the facility’s Administrator, with the assistance of the interim DON and a charge nurse, is somehow less egregious or less serious than the administrative failures discussed in the cases cited by the ALJ.  Moreover, substantial compliance with section 483.75 requires more than merely administering the facility to avoid death or the most serious injuries.  Rather, the facility must be administered in such a way that its residents can “attain or maintain the highest practicable physical, mental, and psychosocial well-being.”  42 C.F.R. § 483.75; see also Avalon Place Trinity at 31.  Vibra failed to meet that standard.

Vibra further argues that the underlying facts of this “single incident of abuse” do not support a finding of noncompliance under section 483.75.  RR at 21.  Vibra’s contention that noncompliance under section 483.75 cannot arise from a “single incident” has no basis in the regulation and is contradicted by Board precedent.  See, e.g., Woodland Oaks  at 16-17 (affirming noncompliance finding under section 483.75 based on noncompliance with other participation requirements arising from management’s failure to act on, report, and adequately investigate a single incident); Pinehurst at 19-20 (affirming noncompliance finding under section 483.75 based on facility’s failure to adequately implement its abuse policy following single incident of abuse); Magnolia Estates Skilled Care, DAB No. 2228, at 21-23 (2009) (affirming noncompliance finding under section 483.75 based on the failure of facility staff, including the director of nursing, to adequately implement policies and procedures in response to single incident affecting resident well-being).¹² 

Accordingly, as outlined above and below, the undisputed evidence establishes that Vibra failed to administer its facility in a way that delivered quality care and services so that its residents, including R1, could “attain or maintain the highest practicable physical, mental, and psychosocial well-being.”  We therefore affirm the ALJ’s determination that Vibra was not in substantial compliance with section 483.75 beginning on July 27, 2015.

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E.       The undisputed material facts establish that Vibra was not in substantial compliance with 42 C.F.R. § 483.75(o) (F520).

Skilled nursing facilities must maintain a quality assessment and assurance committee (QAA committee) consisting of the facility’s DON, a physician, and at least three staff members.  42 C.F.R. § 483.75(o)(1).  The QAA committee “[m]eets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary” and “[d]evelops and implements appropriate plans of action to correct identified quality deficiencies.”  Id. § 483.75(o)(2).  CMS defines “quality assessment” to mean “an evaluation of a process and/or outcomes of a process to determine if a defined standard of quality is being achieved.”  CMS Pub. 100-07, State Operations Manual (SOM), App. PP (Guidance to Surveyors for Long Term Care Facilities), F520 (2015).¹³  “Quality assurance” is defined as “the organizational structure, processes, and procedures designed to ensure that care practices are consistently applied and the facility meets or exceeds an expected standard of quality.”  Id.  The term “quality deficiency” in section 483.75(o) “is meant to describe a deficit or an area for improvement,” and “is not synonymous with a deficiency cited by surveyors.”  Id.  The SOM explains that a QAA committee is “responsible for identifying whether quality deficiencies are present (potential or actual deviations from appropriate care processes or facility procedures) that require action” and, if so, “for developing plans of action to correct them and for monitoring the effect of these corrections.”  Id.  In other words, “the facility’s QAA committee, having identified the root causes which led to their confirmed quality deficiencies, must develop appropriate corrective plans of action.”  In short, section 483.75(o) involves two components:  “[1] the facility must have a committee composed of certain key members that meets at least quarterly (or more often, as necessary); and [2] the committee functions to develop and implement appropriate plans of actions to correct identified quality deficiencies.”  Id. 

Relying on Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002), and focusing only on the first component of section 483.75(o), Vibra argues that section 483.75(o)(1) requires only that a facility have a QAA committee, implying that the regulation does not otherwise address the performance of that committee.  RR at 22.  Vibra’s reliance on Odd Fellow is misplaced.  The Board in Odd Fellow analyzed an allegation of noncompliance under 42 C.F.R. § 483.75(d)(1); it did not address the performance requirements of a QAA committee under section 483.75(o).  See Odd Fellow at 16-17.  As the Board explained, section 483.75(d)(1) requires only that a facility “have a governing body . . . that is legally responsible for establishing and

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implementing policies regarding the management and operation of the facility.”  Id. at 17 (quoting 42 C.F.R. § 483.75(d)(1)).  The Board held that section 483.75(d)(1) was directed at the “existence of a governing body, not the body’s performance” and reversed a noncompliance finding based on the governing body’s failure to “implement” certain policies.  See id.  Section 483.75(o) is different in that it requires the existence of a QAA committee under subsection 483.75(o)(1) and imposes performance requirements for that committee under subsection 483.75(o)(2).  Vibra was cited for noncompliance under section 483.75(o), not because it did not have a QAA committee, but because the performance of its committee was deficient under subsection 483.75(o)(2).¹⁴

The state survey agency cited Vibra for noncompliance under section 483.75(o) at a scope and severity level “L” (widespread substantial noncompliance that poses immediate jeopardy to resident health and safety).  CMS Ex. 4, at 3.  The ALJ found Vibra had a QAA committee (i.e., the QAPI Committee), but it was “ineffective” in that it did not meet and discuss the abuse of R1 until October 1, 2015, and failed to develop and implement “appropriate plans of action” to correct quality deficiencies relating to the abuse of R1.  ALJ Decision at 15-17 (“The undisputed evidence establishes that the facility’s quality assurance committee did not timely address the facility’s abuse issues . . . .”).  We agree with this assessment and find that no rational trier of fact could conclude based on the record evidence that Vibra carried its burden of proving it was in substantial compliance with 42 C.F.R. § 483.75(o).

There is no dispute that before the abuse of R1, Vibra had a written policy requiring a QAPI Committee (composed of the Administrator, the DON, a physician, and three other staff members) that was charged with identifying and responding to “operations and practices that cause negative outcomes.”  CMS Ex. 18, at 1.  Among other things, the policy required the QAPI Committee to meet at least monthly to “[i]dentify issues” requiring “quality assessment and assurance activities,” and to “[d]evelop and implement appropriate plans of action to correct identified quality deficiencies.”  Id.  Additionally, the committee was responsible for identifying “root causes” that have led to confirmed quality deficiencies.  Id. at 2.

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At the time of the survey, Vibra was unable to provide documentation that the QAPI Committee had met in July, August, or September 2015.  CMS Ex. 28, at 5 (¶ 20).  After the survey, Vibra produced two pages of handwritten notes that purported to be meeting notes for August and September 2015.  CMS Ex. 21; CMS Ex. 28, at 5 (¶ 20).  Those notes do not reflect that the QAPI Committee discussed the abuse of R1, identified any quality deficiency relating to the abuse of R1, or developed a plan of action in response to the abuse of R1.  CMS Ex. 21.  In fact, the notes dated August 11, 2015, the first meeting after the July 27 abuse incident, state that no grievances were reported.  Id. at 1.     

The meeting minutes of October 1, 2015, provide the first indication that the QAPI Committee met and discussed the abuse of R1.  CMS Ex. 28, at 5 (¶ 21); CMS Ex. 20 (typewritten minutes).  The “New Business” section of the minutes indicates that the committee recommended only that staff be retrained on the facility’s abuse policies and procedures.  CMS Ex. 20, at 1.  There is no evidence that the QAPI Committee identified (or even considered) the root cause of the abuse; the factors that placed R1 and the other residents at risk of abuse; the reporting failures of staff at every level; the issue of allowing the abusers to continue working at the facility pending an investigation; or the fact that key members of the QAPI Committee (the former Administrator and interim DON) were themselves perpetrators of the abuse.  The record does not reflect what, if anything, the QAPI Committee identified as a quality deficiency relating to either the abuse of R1, or the facility’s initial response to that abuse.  Moreover, there is no evidence that before the December 2015 survey the QAPI Committee developed and implemented an appropriate plan of action to correct quality deficiencies relating to the abuse of R1.  Such failures plainly constitute noncompliance under section 483.75(o).  See, e.g., Alexandria Place, DAB No. 2245, at 22, 24 (2009) (holding that failure of facility’s QAA committee to respond to quality deficiency and develop appropriate action plan constituted noncompliance under section 483.75(o) at immediate-jeopardy level). 

In its reply brief, Vibra asserts that “members” of the QAPI Committee were “actively involved” in various remedial actions that the facility undertook in response to the abuse of R1.  Reply at 6 n.2.  While there is evidence that some members of the committee working in their individual capacities (e.g., the medical director and social worker) took some steps to address the abuse of R1 (see P. Ex. 2), Vibra presented no evidence that the QAPI Committee itself identified any quality deficiency relating to the abuse of R1 or developed an appropriate corrective action plan at any time before the survey.  See Jewish Home of Eastern Pa., DAB No. 2380, at 12 (2011) (finding noncompliance under section 483.75(o) where facility failed to identify what was reviewed by the QAA committee, whether any potential or actual quality deficiency had been identified, or whether any corrective action plan had been developed), aff’d, No. 11-2616, 2012 WL 834129 (3rd Cir. Mar. 14, 2012).  Accordingly, we affirm the ALJ’s determination that Vibra was not in substantial compliance with section 483.75(o) in the aftermath of the abuse of R1.

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II.      Vibra presented no evidence that could lead a rational trier of fact to conclude that CMS’s immediate jeopardy determination is clearly erroneous or that it returned to substantial compliance earlier than the date determined by CMS.

A.       CMS’s immediate jeopardy determination is not clearly erroneous.

“Immediate jeopardy,” as noted above, is defined as “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  When evaluating the determination of immediate jeopardy, the ALJ and Board must defer to CMS’s assessment unless the facility shows it is clearly erroneous.  Neighbors Rehab. Ctr., LLC, DAB No. 2859, at 18 (2018) (citing 42 C.F.R. § 498.60(c)(2) (“CMS’ determination as to the level of noncompliance of a SNF [skilled nursing facility] . . . must be upheld unless it is clearly erroneous.”)), aff’d, 910 F.3d 919 (7th Cir. 2018).  As the Board has explained, “a facility bears a heavy burden in challenging the assessment of immediate jeopardy, which, of necessity, includes an element of judgment.”  Id. (citations omitted).  Under the clearly erroneous standard, CMS’s immediate jeopardy determination is “presumed to be correct.”  Universal Health Care – King, DAB No. 2383, at 16 (2011) (citations omitted), aff’d, 499 F. App’x 299 (4th Cir. 2012).  “Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy; rather, the burden is on the facility to show that that determination is clearly erroneous.”  Id. (citations omitted).  

Here, the SOD identifies the findings based on which the state agency found deficiencies at the immediate jeopardy level under sections 483.13(b), 483.13(c), 483.20(k)(3)(i), 483.75, and 483.75(o).  CMS Ex. 4, at 1-3.  The state agency further determined that the conditions resulting in immediate jeopardy were not abated until December 16, 2015.  Id. at 5.  That assessment, and the underlying survey findings, constitute evidence supporting CMS’s determination of immediate jeopardy.  Nothing more was required to establish CMS’s immediate jeopardy determination and shift the burden to Vibra to demonstrate that the immediate jeopardy determination was clearly erroneous.  See Barbourville Nursing Home, DAB No. 1962, at 11 (2005) (“CMS was not required to produce evidence other than the SOD to support its determination of immediate jeopardy here.”), aff’d, 174 F. App’x 932 (6th Cir. 2006).¹⁵  The ALJ found that subjecting a facility resident to an unauthorized body cavity search is “likely to cause any resident serious harm” and that “R1 suffered actual harm as a result of the assault.”  ALJ Decision at 17.

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The ALJ further found that Vibra’s deficiencies, including the failures to timely report and take other actions to protect facility residents, “were likely to cause serious harm to vulnerable facility residents, and, in fact, caused actual harm to one resident.”  Id.  The ALJ concluded that CMS’s immediate jeopardy determination was not clearly erroneous.  Id.       

On appeal, Vibra does not dispute that it was noncompliant with one or more participation requirements at the immediate jeopardy level as of July 27, 2015.  Vibra presented no evidence or argument that its noncompliance did not cause actual harm to R1 and was not likely to cause serious harm to other facility residents before the date that Vibra suspended the “offending employees.”  RR at 17.  Accordingly, we summarily affirm the ALJ’s conclusion upholding CMS’s determination that Vibra was noncompliant with sections 483.13(b), 483.13(c), 483.20(k)(3)(i), and 483.75 at the immediate jeopardy level beginning on July 27, 2015.¹⁶

B.       CMS’s determination as to the duration of immediate jeopardy is not clearly erroneous.

While Vibra does not contest CMS’s determination that its noncompliance rose to the level of immediate jeopardy beginning on July 27, 2015, Vibra submits that it returned to substantial compliance or, alternatively, abated the immediate jeopardy level of noncompliance by August 1, 2015.  RR at 7 (“Vibra submits that the record establishes by a preponderance of the evidence that by August 1, 2015, the Facility was in substantial compliance with the [participation requirements] on appeal or, in the alternative, the determination that any continued noncompliance was at the level of immediate jeopardy is clearly erroneous.”), 17 (“[N]either CMS nor the ALJ offers material facts to support finding immediate jeopardy existed after the suspension of the offending employees [on July 31, 2015].”), 17 (“[T]here nonetheless is a complete lack of evidence to support immediate jeopardy existed after July 31, 2015.”); see also Reply at 3 (arguing for a reduction in the duration of the immediate jeopardy designation and related penalty).  Vibra contends the ALJ erred in upholding CMS’s determination that Vibra’s noncompliance remained at the immediate jeopardy level through December 15, 2015, and that Vibra remained out of substantial compliance through January 18, 2016.  We find both arguments are without merit for the reasons explained below.

Vibra’s burden of demonstrating clear error extends to overcoming CMS’s determination as to the duration of immediate jeopardy.  See Universal Health Care at 16 (citing Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336, at 7-8 (2010)); see also Owensboro

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Place & Rehab. Ctr., DAB No. 2397, at 12-13 (2011).  As the Board held in Brian Center, a determination by CMS that the facility’s noncompliance continued at the immediate jeopardy level during a specified period “constitutes a determination about the ‘level of noncompliance’ and, therefore, is subject to the clearly erroneous standard of review under section 498.60(c)(2).”  Brian Center at 7-8.  Thus, once a facility is “found to have placed residents in an immediate jeopardy situation,” it “is presumed to continue to present immediate jeopardy unless the facility shows that the determination of continued immediate jeopardy is clearly erroneous.”  The Bridge at Rockwood, DAB No. 2954, at 29 (2019) (citing Brian Center at 7-8).  As further explained below, Vibra presented no evidence that could lead a rational trier of fact to conclude that Vibra can meet that burden here.  See Dumas at 5 (on summary judgment the tribunal “must view the evidence presented through the prism of the substantive evidentiary burden” (quoting Anderson, 477 U.S. at 255)).

As an initial matter, Vibra complains that the duration of its noncompliance was due to the delay (more than four months) between the abuse incident and the state agency’s survey.  RR at 10 (challenging CMS’s determination concerning the duration of noncompliance and immediate jeopardy “primarily based on [the state agency’s] unreasonable delay in commencing the investigation”); Reply at 3 (arguing that the duration of immediate jeopardy and resulting penalty was “primarily driven by the failure of the state agency to appear for more than four months”).  In this regard, Vibra asserts “that the predicate to the immediate jeopardy designation and its removal is the complaint investigation itself, which was unreasonably and inexplicably delayed for more than four months after the alleged abuse was reported.”  RR at 13. 

To the extent that Vibra contends its ongoing noncompliance at the immediate jeopardy level was the fault of the state agency for not commencing its abuse investigation sooner, the Board has long rejected the notion that a facility is unable to abate immediate jeopardy or return to substantial compliance until surveyors have identified the deficiencies that require correction.  See Century Care of Crystal Coast, DAB No. 2076, at 25 (2007) (rejecting argument that facility could not correct immediate jeopardy situation until the survey exposed it), aff’d, 281 F. App’x 180 (4th Cir. 2008); see also Life Care Ctr. of Tullahoma, DAB No. 2304, at 59-60 (2010) (rejecting argument that facility could not be penalized for noncompliance existing before the survey because, among other things, a facility “is expected to be in substantial compliance with Medicare participation requirements at all times”), aff’d, 453 F. App’x 610 (6th Cir. 2011); Pinehurst Healthcare & Rehab. Ctr., DAB No. 2246, at 34-35 (2009) (rejecting argument that CMPs could not begin to accrue earlier than the date of the survey that identified the immediate jeopardy); Fairfax Nursing Home, Inc., DAB No. 1794, at 18 (2001) (“The suggestion by [the facility] that only if it knows in advance that a penalty will be imposed does it have sufficient notice that it should take steps to correct a deficiency is disingenuous.”), aff’d, 300 F.3d 835 (7th Cir. 2002), cert. denied, 537 U.S. 1111 (2003).  If Vibra’s theory were correct, then skilled nursing facilities would be unaccountable for

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any noncompliance until it is identified by surveyors and absolved of any responsibility to address deficiencies between surveys.  We will not countenance such a result here.  Even if the state agency’s investigation of the abuse incident were untimely—a question we do not decide—a delay in the investigation does not excuse Vibra’s continuing noncompliance with Medicare participation requirements.¹⁷  Facilities must comply with these requirements regardless of when the deficiencies are discovered by a state agency.  See Owensboro at 11 (explaining that facilities “cannot expect to always have advance notice” that a penalty will be assessed in the immediate jeopardy range and, in any event, are “required to take corrective action, regardless of the level of noncompliance”). 

Vibra further contends that neither CMS nor the ALJ offered “material facts” to support finding immediate jeopardy after July 31, 2015, when it suspended the three “offending employees” that participated in the abuse of R1.  RR at 17.  Vibra misapprehends the allocation of the burden of persuasion concerning the duration of noncompliance and immediate jeopardy.  As explained above, Vibra’s burden of demonstrating clear error extends to overcoming CMS’s determination as to the duration of immediate jeopardy.  See Universal Health Care at 16.  Thus, Vibra had the burden of showing that it completed its abatement plan and removed the immediate jeopardy on a date earlier than that determined by CMS.  See Owensboro at 12-13 (“[I]t is not incumbent on CMS to justify the [abatement] date, but, rather, on [the facility] to show an earlier date of abatement . . . .”).  Vibra’s focus on its initial response to the abuse of R1, including the suspension of the abusers, falls far short of showing that it abated the immediate jeopardy by July 31, 2015.

The Board has long held that “immediate jeopardy is abated ‘only when the facility has implemented necessary corrective measures so that there is no longer any likelihood of serious harm.’”  Glenoaks Nursing Ctr., DAB No. 2522, at 19 (2013) (quoting Life Care Ctr. of Bardstown, DAB No. 2479, at 35); see also Countryside Rehab. & Health Ctr. at 25; Covington Manor Nursing Home, DAB No. 2789, at 7 (2017); Florence Park Care Ctr., DAB No. 1931, at 30 (2004).  “The facility must allege and prove that it has abated the conditions that created the immediate jeopardy and act to prevent their recurrence.”  The Bridge at Rockwood at 29 (citing Life Care Ctr. of Elizabethton, DAB No. 2367, at 16 (2011)).  As explained in Glenoaks:

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Findings about incidents related to individual residents are not themselves the deficiencies that must be corrected – the deficiency is the underlying failure to meet a participation requirement evidenced by the incident. . . .  In other words, it is not sufficient for a facility to abate immediate jeopardy by addressing the deficiency with respect to the condition of one resident.  Instead, the facility needs to address and correct the conditions underlying the noncompliance that created the immediate jeopardy.

Glenoaks at 19-20 (citations and internal quotation marks omitted); see also Countryside at 26 (“[I]n order to abate the immediate jeopardy condition, [the facility] needed to do more than neutralize the threat to resident safety posed by [the abuser’s] presence in the facility.  It also needed to take concrete steps toward correcting the regulatory violations that allowed the threat to exist in the first place.”).  As explained above, the regulatory violations in this case were not limited to the acts or omissions of the three “offending employees” who were suspended several days after the abuse allegations came to light.  Thus, merely removing the abusers from the facility, while a necessary initial step to protect residents, did nothing to address the administrative failures underlying Vibra’s noncompliance with sections 483.13(b), 483.13(c), 483.20(k)(3)(i), 483.75, and 483.75(o) that created the immediate jeopardy.

Moreover, as a general rule, a facility will not be considered to have successfully abated immediate jeopardy until it has at least completed the steps it determined were necessary to accomplish that goal.  See Countryside at 27 n.12 (“The Board ordinarily holds that a SNF cannot be regarded as having returned to substantial compliance, or abated immediate jeopardy, until measures specified in an approved plan of correction, or plan to remove immediate jeopardy, have been implemented.”); Brian Center at 9 (“[A]batement of an immediate jeopardy condition (or removal of noncompliance) ordinarily requires the performance of corrective measures that the facility has included in a plan of correction.”); Meridian Nursing Ctr., DAB No. 2265, at 20-21 (2009) (affirming the determination of a multi-day immediate jeopardy period because, although the facility had taken certain corrective measures prior to the survey, the facility failed to show that it had implemented all of the corrective actions that its own staff determined to be necessary to abate immediate jeopardy), aff’d, 604 F.3d 445 (7th Cir. 2010); Lake Mary Health Care, DAB No. 2081, at 29 (2007) (holding that the burden was on the facility to show that it timely completed the implementation of its plan to abate immediate jeopardy).

Here, Vibra’s abatement plan (i.e., the AOC) specified several corrective measures completed after July 31, 2015, that went beyond the removal of the three “offending employees.”  See CMS Ex. 30.  The AOC specified that Vibra terminated the three employees involved in the abuse on August 2, sent a follow-up report to the state agency on August 3, hired a new DON on August 11, hired a new Administrator on September 12, and terminated the CEO on September 28.  Id. at 1-2.  In addition,

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according to the AOC, Vibra appointed its Administrator (RF) to be the Abuse and Neglect Coordinator on December 15, 2015.  Id. at 1; see also CMS Ex. 28, at 6 (¶ 26).  Having specified these corrective measures in its abatement plan, measures that went beyond merely removing the abusers, Vibra “cannot be regarded as having abated the immediate jeopardy until the date those measures were implemented.”  Brian Center at 10-11 (rejecting argument that facility abated immediate jeopardy when it fired nurse who failed to initiate CPR on unresponsive resident where other corrective measures in facility’s abatement plan had not been implemented).

Still further, CMS determined that Vibra’s administrative failures perpetuated the immediate-jeopardy-level risk of harm to residents, and the corresponding deficiency under section 483.75(o) continued at the immediate jeopardy level until Vibra undertook various steps at the time of the survey to address that noncompliance.  MSJ at 20 (“These QAA failures perpetuated the jeopardy-level risks of harm to residents, and they continued at the jeopardy-level until abated when [Vibra] revised its QAPI policy, designated a QAPI coordinator to oversee and monitor the plan of correction, and designated an abuse coordinator.”); see also CMS Ex. 28, at 6-7 (¶¶ 25-26) (discussing failures of the QAPI Committee in response to the abuse of R1 and Vibra’s efforts to address those deficiencies at the time of the survey).¹⁸  As CMS noted, “[t]hese actions were not completed until December 16, 2015.”  MSJ at 20. 

Among other things, Vibra revised its QAPI and QAA policies, issuing new policies and procedures on December 15 and December 16, 2015.  CMS Ex. 19 (revised policies); CMS Ex. 28, at 6-7 (¶ 26).  The stated purpose of the revised QAPI policy was to “promote a culture of quality” within the facility that includes “an organization-wide management and staff philosophy of continuous quality improvement in programs, service delivery and resident health outcomes.”  CMS Ex. 19, at 1.  The revised QAA policy further indicated a commitment to the quality assessment and assurance “management process” that is “ongoing[,] [m]ulti-level, and facility wide.”  Id. at 2.  The new policies included the designation of a new Quality Assurance Coordinator, development of a medical QAPI committee that meets quarterly, and a facility QAPI committee that meets monthly.  CMS Ex. 19, at 1; CMS Ex. 28, at 6-7 (¶ 26).  All these changes were introduced at the time of the survey and led to the state agency’s subsequent conclusion that, based on its “[o]bservations, interviews, and review of

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policy,” the immediate jeopardy condition had been removed as of December 16, 2015.  CMS Ex. 4, at 5; see also CMS Ex. 28, at 6-7 (¶¶ 25-26).  Based on these uncontroverted facts, we cannot conclude that CMS’s determination regarding the duration of immediate jeopardy is clearly erroneous.

We are also unpersuaded by Vibra’s reliance on Board “precedent” in Cedar View Good Samaritan, DAB No. 1897 (2003), and Beverly Health Care Lumberton, DAB No. 2156 (2008).  Vibra asserts that in both cases, which involved resident abuse, the Board “affirmed” an ALJ’s conclusion that CMS had clearly erred in determining that residents were in immediate jeopardy after the date the facility had removed the abuser and reported the incident.  RR at 14.  The Board “affirmed” no such conclusion in either case.  In Cedar View, the Board found CMS’s cross-appeal on this issue was untimely and specifically declined to review it.  See DAB No. 1897, at 20 (concluding that CMS “failed to make a timely request for Board review” of the ALJ’s clear-error determination concerning the duration of immediate jeopardy).  In Beverly Health, CMS declined to appeal the ALJ’s conclusion reducing the period of immediate jeopardy by two days and, therefore, the Board specifically declined to review it.  See DAB No. 2156, at 16 & n.7 (“CMS did discuss in its brief its disagreement with the ALJ’s reasoning.  CMS does not seek to have the Board take any action based on this disagreement, however, concluding only that CMS ‘respectfully requests that the [Board] affirm’ the ALJ Decision.” (internal cites omitted)).  We further note that neither case involved all of the deficiencies at issue here, including widespread noncompliance under section 483.75(o) that posed immediate jeopardy to resident health and safety and, as explained above, demanded corrective measures that went far beyond merely removing the abusers and reporting the incident.

Based on the foregoing, we conclude that no reasonable decision-maker properly applying the clearly erroneous review standard could find in Vibra’s favor based on the undisputed facts in this record.  Accordingly, we affirm the ALJ’s conclusion that CMS’s determination concerning the duration of immediate jeopardy was not clearly erroneous.

C.       Vibra did not return to substantial compliance earlier than the date determined by CMS.

Vibra’s Plan of Correction (POC), which Vibra asserts was submitted to CMS on January 1, 2016, outlined the measures it would take to achieve substantial compliance.  CMS Ex. 4; see also RFH at 2.  Vibra indicated, among other things, that it would identify on a monthly basis all residents most at risk for abuse and update their care plans accordingly.  CMS Ex. 4, at 6-7, 14.  Additionally, Vibra specified that the QAPI Committee would review the list of such residents each month to ensure their care plans have been updated.  Id. at 7.  Vibra further indicated it would designate a Quality Assurance Coordinator, which it had not done at the time of the survey, to lead the QAPI Committee and, along with the Regional CEO, ensure the QAPI Committee “addresses all areas relevant to [the] plan of correction.”  Id. at 38, 40.  Vibra also designated a

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Director of Quality Management to monitor implementation of the POC and to oversee the QAPI Committee and Quality Assurance Coordinator.  Id. at 9, 17, 38.  Vibra designated January 19, 2016, as the “completion date” for all these corrective measures.  Id. at 5-9, 13-17, 19-26, 31-40.  Following a revisit survey, CMS confirmed that Vibra had returned to substantial compliance on January 19, 2016.  CMS Ex. 2; see also CMS Ex. 28, at 7 (¶ 27) (confirming Vibra’s identification of residents most at risk of abuse was not completed until January 2016); CMS Ex. 33 (revisit survey notes). 

“The Board has long held that CMS does not need to establish noncompliance on each day for which it imposes a CMP.”  Glenoaks at 18 (citing Regency Gardens Nursing Ctr., DAB No. 1858, at 7-11 (2002)).  Rather, “noncompliance is presumed to continue until the facility demonstrates that it has achieved substantial compliance.”  Id. (citing Cary Health & Rehab. Ctr., DAB No. 1771, at 23-24 (2001)).  Vibra, therefore, had the burden of showing that it implemented its plan of correction and returned to substantial compliance before the date determined by CMS.  Owensboro at 13.

Having specified certain corrective measures in its POC (CMS Ex. 4), measures that went beyond the prior actions undertaken to remove the immediate jeopardy, Vibra cannot be regarded as having returned to substantial compliance until the date those measures were implemented.  See Cal Turner Extended Care Pavilion, DAB No. 2030, at 19 (2006) (rejecting facility’s “claim that steps short of those which the facility itself identified as necessary for it to correct the problems found (and to achieve substantial compliance) should nevertheless be accepted as adequate to require lifting the remedies imposed”); see also Countryside at 27 n.12; Brian Center at 9.

Vibra made no showing that all the corrective measures specified in its POC were implemented before the date of completion that Vibra specified in the POC.  “The Board has long rejected as contrary to the goals of the program” the notion “that a facility can belatedly claim to have achieved substantial compliance at a date earlier than it even alleged that it had done so” in a plan of correction.  Cal Turner at 18.  Accordingly, we find no error in the ALJ’s conclusion that Vibra failed to show a return to substantial compliance earlier than January 19, 2016. 

III.     The CMP amounts imposed by CMS are reasonable.

When a skilled nursing facility is found noncompliant with one or more participation requirements, we may review whether a CMP imposed by CMS is reasonable.  See Crawford Healthcare & Rehab., DAB No. 2738, at 18-19 (2016); see also 42 C.F.R. § 488.438(e).  In deciding whether a CMP is reasonable, we may consider only the factors specified in 42 C.F.R. § 488.438(f).  See Crawford Healthcare at 19 (citing 42 C.F.R. § 488.438(e)(3)).  Those factors are: (i) the facility’s history of noncompliance; (ii) the facility’s financial condition – that is, its ability to pay the CMP; (iii) the factors specified in 42 C.F.R. § 488.404 (i.e., the “seriousness” of the noncompliance, and “the

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relationship of the one deficiency to other deficiencies resulting in noncompliance”); and (iv) 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), 488.404(a)-(c).  In conducting this review, “we presume that CMS considered the regulatory factors in choosing a CMP amount and that those factors support the penalty imposed.”  Crawford Healthcare at 19 (citing Coquina Ctr., DAB No. 1860, at 32 (2002) (“[T]here is a presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS.”); Brenham Nursing & Rehab. Ctr., DAB No. 2619, at 18 (2015)).  “‘Accordingly, the burden is not on CMS to present evidence bearing on each regulatory factor, but on the [facility] to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.’”  Crawford Healthcare at 19 (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375, at 26-27 (2011)). 

“Whether a CMP amount is reasonable is a legal, not a factual, issue.”  Id. (citing Cedar Lake at 12).  To overcome a summary judgment motion as to the reasonableness of a CMP, the facility “must proffer evidence sufficient to create a genuine dispute about facts affecting our assessment of the relevant regulatory factors.”  Id.  For the reasons explained below, we find that Vibra has not identified a genuine dispute of material fact relating to any of the regulatory factors that would affect our assessment or justify a reduction in the per-day CMP amounts.

In this case, CMS imposed two CMPs:  a $7,000 per day CMP for 142 days of noncompliance at the immediate-jeopardy level (July 27, 2015 through December 15, 2015); and a $200 per day CMP for 34 days of noncompliance below the immediate-jeopardy level (December 16, 2015 through January 18, 2016).  As the ALJ found, the $7,000 per day CMP is in the middle of the range ($3,050 to $10,000) for noncompliance at the immediate-jeopardy level, and the $200 per day CMP is at the low end of the range ($50 to $3,000) for noncompliance below the immediate jeopardy level.  ALJ Decision at 20 (citing 42 C.F.R. § 488.438(a)(1)(i)-(ii)).  The ALJ concluded that the per-day CMPs were reasonable based on the regulatory factors.  ALJ Decision at 20-22.

Pointing to both the per-day CMP amounts and the total accrued penalty of $1,000,800, Vibra argues that the CMPs are unreasonable in comparison to other cases involving resident abuse.  RR at 15-16 (citing two ALJ decisions that Vibra contends involved similar or more egregious abuse); Reply at 12 (citing a third ALJ decision for comparison).  Vibra’s argument has no merit.  First, the issue here is the reasonableness of the per-day amounts, not the total accrued penalty amount (which is a function of the duration of noncompliance).  See Kenton Healthcare, LLC, DAB No. 2186, at 28 (2008).  “Stating that the total CMP amount is ‘not reasonable’ does not raise a clear dispute about the reasonableness of the per-day CMP amounts.”  Crawford Healthcare at 20 (internal quotation marks and citations omitted). Thus, in reviewing the reasonableness

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of a CMP, “‘we look at the per day amount, not at the total amount of the CMP.’”  Id. (quoting Century Care of Crystal Coast, DAB No. 2076, at 26).  

Second, CMS has “considerable discretion” under the regulations to determine, on a case-by-case basis, the appropriate penalty to impose based on the regulatory factors.  See Alexandria Place at 31 (rejecting argument that CMPs are unreasonable based on case comparison).  As the Board made clear, “[a]dministrative review of a CMP’s reasonableness must be based solely on the previously mentioned regulatory factors as they apply to the facts of each case.”  Crawford Healthcare at 21 (citing 42 C.F.R. § 488.438(e)(3)).  The regulatory factors do not require CMS to compare the facts of one case to other cases to determine the CMP amount.  Id.  Moreover, “[i]t would be almost impossible to make any true comparisons of different cases since the underlying facts of noncompliance vary considerably, as do the other factors.”  Alexandria Place at 31; see also Western Care Mgmt. Corp., DAB No. 1921, at 94 (2004) (“Case-to-case comparisons generally have little value given the unique circumstances of each case and the myriad factors that must be considered.”); Brier Oak Terrace Care Ctr., DAB No. 1798, at 13-14 (2001) (rejecting case comparison argument and explaining that “[t]he factors in each case cannot be quantified to determine the appropriate amount of a CMP”).¹⁹

While we reject the contention that the CMPs imposed here should be reduced based on a comparison of CMPs imposed in other cases, we further note that Vibra failed to show that the facts in the other cases bearing on each regulatory factor were the same as, or similar to, the facts here.  Merely showing that other cases with lesser per-day CMP amounts involved more than one abuse incident or abuse that Vibra contends is somehow more egregious than the unauthorized body cavity search of R1, fails to account for the myriad differences in Vibra’s case including the number, nature, and seriousness of the deficiencies, as well as differences in the facts bearing on each regulatory factor.  Among other things, Vibra did not show that the other cases involved resident abuse committed by three high-level employees, including members of the facility’s quality assessment and assurance committee, nor did Vibra show that the other cases involved the kind of widespread administrative failures found in this case.  As discussed below, these facts go to the degree of culpability and the seriousness of noncompliance and, among other things, distinguish this case from other abuse cases.

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Turning to the regulatory factors, Vibra asserts that the ALJ failed to “fairly address” each factor and that the ALJ Decision is “deficient for failing to address all of the required factors.”  RR at 18.  This is not accurate.  The ALJ specifically considered each regulatory factor, including Vibra’s history of noncompliance, its financial condition, the seriousness of the noncompliance, the relationship of one deficiency to other deficiencies resulting in noncompliance, and its degree of culpability.  ALJ Decision at 20-22. 

Regarding Vibra’s history of noncompliance, the ALJ noted that the facility did not have a long history of Medicare participation but was cited for noncompliance with multiple health and life safety code requirements following its first annual survey in March 2014 and second annual survey in January 2015.  ALJ Decision at 20 (citing CMS Ex. 29).  In March 2014, Vibra was cited for fourteen deficiencies having the potential for more than minimal harm.  CMS Ex. 29, at 2.  Two of those deficiencies were cited as being widespread (Level F), including, as in this case, noncompliance with section 483.20(k)(3)(i) (Tag F281) for failing to provide services meeting professional standards of quality.  Id.  In January 2015, less than a year after the first annual survey, Vibra was cited for six deficiencies all having the potential for more than minimal harm, including repeated deficiencies under Tags F309 and F328.  Id. at 1-2.²⁰  While Vibra’s prior noncompliance did not rise to the level of actual harm or immediate jeopardy, there is no dispute that in a period spanning less than 12 months, Vibra was found to be out of compliance with eighteen participation requirements, all of which had the potential for more than minimal harm, two of which were repeated, and some of which were found to be widespread.  Based on these undisputed facts, we are not persuaded that Vibra’s history of noncompliance justifies a reduction in the per-day CMP amounts.

Regarding the facility’s financial condition, the relevant inquiry is “whether the facility can show that it lacks ‘adequate assets to pay the CMP without having to go out of business or compromise resident health and safety.’”  Oceanside Nursing & Rehab. Ctr., DAB No. 2382, at 23 (2011) (quoting Gilman Care Ctr., DAB No. 2357, at 7 (2010)); see also Western Care Mgmt. at 91 (citing Windsor Health Care Ctr., DAB No. 1902 (2003)); Final Rule, Medicare and Medicaid Programs; Survey, Certification and Enforcement of Skilled Nursing Facilities and Nursing Facilities, 59 Fed. Reg. 56,116, 56,204 (Nov. 10, 1994)).  Moreover, when a facility is a subsidiary of a larger organization or one of several inter-related entities with common ownership, all the financial resources that the facility may access may be considered in assessing the facility’s ability to pay a CMP.  See Littlefield Hospitality, DAB No. 2756, at 11-12 (2016) (concluding that facility’s failure to offer evidence about the financial resources of

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its parent company further demonstrates its failure to establish that payment of the CMP would drive it out of business or compromise resident care); Oceanside at 23 (noting that a facility’s access to significant financial resources of its affiliated companies and owner may be considered in assessing its ability to pay a CMP).

Here, the ALJ acknowledged that Vibra submitted a declaration from the Chief Financial Officer of Vibra Healthcare, LLC,²¹ reporting that Vibra had significant financial losses in 2015 and 2016 and asserting that the CMP will cause additional financial hardship for Vibra; however, the ALJ correctly noted that Vibra “has not shown, nor even alleged, that paying the penalty would cause it to go out of business.”  ALJ Decision at 21 (citing P. Ex. 7 (Fegan Decl., ¶¶ 4, 6-7)).  In fact, it is undisputed that Vibra is part of a larger healthcare organization that was able to borrow funds to pay the penalty into CMS’s escrow account.  P. Ex. 7, ¶¶ 2, 7 & Attachment 1.  The ALJ, therefore, concluded that the evidence “does not justify lowering the CMP based on its financial condition.”  ALJ Decision at 21.  On appeal, Vibra does not challenge the ALJ’s assessment of its financial condition, and there is no dispute Vibra was able to pay the entire CMP into escrow and remains operational.  P. Ex. 7, ¶¶ 7-8.  Given these undisputed facts, including Vibra’s access to significant financial resources, we conclude Vibra has not established that its financial condition warrants a reduction in the CMP.

With respect to the factors specified in 42 C.F.R. § 488.404(b)-(c), including the “seriousness” of the deficiencies and the relationship of one deficiency to other deficiencies, the ALJ considered all the deficiencies resulting in noncompliance, including those not appealed.  ALJ Decision at 21.  “Seriousness” is a function of the scope of noncompliance (whether a deficiency is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether a deficiency has created a “potential for” only “minimal harm” or a potential for “more than minimal harm,” resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R.§ 488.404(b).  Here, Vibra appealed only the five deficiencies cited at the immediate-jeopardy level, including four at scope-and-severity level J, referring to isolated, immediate jeopardy (Tags F223, F226, F281, and F490), and one at scope-and-severity level L, referring to widespread, immediate jeopardy (Tag F520).  CMS Ex. 4, at 1-3; ALJ Decision at 3.  As discussed above, all five of these immediate-jeopardy deficiencies have been established, and any one of them would support a per-day CMP of no less than $3,050 and no more than $10,000.  See 42 C.F.R. § 488.438(a)(1)(i).  Given that CMS established five deficiencies at the immediate-jeopardy level, including one widespread deficiency, we can discern no basis for reducing the $7,000 per-day CMP amount based on the regulatory factors in section 488.404(b)-(c).

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The ALJ also considered the non-appealed deficiencies constituting noncompliance, finding that they reflected “serious problems, which, by themselves show a level of disregard of resident care, comfort and safety,” even if they did not rise to the level of immediate jeopardy.  ALJ Decision at 21.  As noted above, Vibra did not appeal noncompliance findings related to a medication error (Tag F333), the failure to appoint a licensed administrator (Tag F493), and the failure to have arrangements with outside sources for dialysis and dental services (Tag F500).  See supra at 9 n.6.  While these deficiencies were not cited at the immediate-jeopardy level, all of them had the potential for more than minimal harm, and further support the CMP amount imposed by CMS.  See Brian Center at 14 (considering the severity and scope of all deficiencies constituting noncompliance, including non-immediate jeopardy deficiencies, in determining that per-day CMP amount is reasonable). 

Finally, as to the degree of culpability, the ALJ found the acts and omissions of Vibra’s staff (at the highest levels) reflected a “high degree of neglect, indifference, and disregard for resident care, comfort, or safety, particularly R1’s care, comfort, and safety for which the facility is culpable.”  ALJ Decision at 21-22.  Vibra argues that the ALJ’s conclusion in this regard is “not supported by (and contradicted by) the substantial evidence in the record.”  RR at 19.  Specifically, Vibra narrowly focuses on the ALJ’s assertions that the “CEO misled the state agency as to the seriousness of the abuse allegations” and “Staff made no efforts to assess or protect R1 in the aftermath of the abuse.”  RR at 18 (arguing that the ALJ’s characterization of the evidence is “wildly inaccurate and inflammatory”).  We agree that neither of these assertions by the ALJ is appropriate in the context of summary judgment (which required the ALJ to view the record in the light most favorable to Vibra) and we do not adopt this characterization of the evidence in our de novo review of the matter.  To be clear, we do not find it “undisputed” that the CEO misled the state agency and that no staff members acted to assess or protect R1 in the aftermath of the abuse.  Nevertheless, as detailed above, the record is replete with uncontroverted evidence demonstrating a high degree of culpability in terms of the abuse of R1 by members of the facility’s administrative team (including members of the QAPI Committee) who were the very people responsible for preventing this kind of abuse.  And, while Vibra implemented certain corrective measures in response to the abuse of R1 (RR at 17-18), many of those measures were not timely implemented and other necessary measures were not implemented at all until the time of the survey.  Given the undisputed facts in this case, we find no basis to reduce the CMPs based on Vibra’s degree of culpability.  Cf. Crawford at 20 (rejecting argument that a facility’s culpability may be lessened by its implementation of certain remedial measures, where other necessary remedial measures were not timely implemented by the facility).²²  

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In short, Vibra has not identified a genuine dispute of material fact relating to any of the regulatory factors that would affect our assessment of those factors or justify a reduction in the per-day CMP amounts.  Accordingly, we sustain the ALJ’s determination that the $7,000 per-day CMP imposed for the period of noncompliance at the immediate-jeopardy level was reasonable.  Vibra did not argue that the $200 per-day CMP imposed for the period of noncompliance below the immediate-jeopardy level was unreasonable and, therefore, we sustain that determination as well.

Conclusion

For the reasons stated, we uphold the ALJ’s determination that Vibra was not in substantial compliance with 42 C.F.R. §§ 483.13(b), 483.13(c), 483.20(k)(3)(i), 483.75, and 483.75(o) from July 27, 2015, through January 18, 2016, and that Vibra’s noncompliance was at the immediate-jeopardy level from July 27, 2015, through December 15, 2015.  We further uphold the ALJ’s determination that the CMPs imposed by CMS – $7,000 per day from July 27 through December 15, 2015, and $200 per day from December 16, 2015, through January 18, 2016 – are reasonable.

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Endnotes

¹ In October 2016, the participation requirements for long-term care facilities in subpart B of Part 483, including those at issue here, were revised.  Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed Reg. 32,256 (July 13, 2017) (technical corrections).  We rely on the regulations in effect in December 2015 when the state survey agency conducted the investigation and survey in this case.  See Carmel Convalescent Hosp., DAB No. 1584, at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey).

² The Statement of Deficiencies (CMS Form 2567) identifies deficiency citations using “F-tags” that correspond to the relevant regulatory requirements and CMS’s guidance on the requirements.  See generally CMS Pub. 100-07, State Operations Manual, Chapter 7, Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities.  The Manual and Appendices to the Manual are available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.

³ RF had previously applied to the state licensing board for a nursing home administrator’s license and was granted a provisional license with an effective date of September 30, 2015.  CMS Ex. 22.

⁴ The imposition notice set forth additional enforcement remedies, including the denial of payment for new admissions (DPNA) and the termination of Vibra’s provider agreement.  CMS Ex. 1, at 2-3.  These remedies did not go into effect because Vibra achieved substantial compliance before their effective date.  CMS Ex. 2.

⁵ A POC is “a plan developed by the facility and approved by CMS or the survey agency that describes the actions the facility will take to correct deficiencies and specifies the date by which those deficiencies will be corrected.”  42 C.F.R. § 488.401 (definitions); see also id. § 488.402(d) (a facility with deficiencies must submit a POC for approval by CMS or the state survey agency).  In its request for hearing (RFH), Vibra represented that it timely submitted its POC to CMS and the state agency by facsimile on January 1, 2016.  RFH at 2.

⁶ Vibra did not appeal deficiencies related to a medication error (§ 483.25(m)(2) - Tag F333), the failure to appoint a licensed administrator (§ 483.75(d)(l )-(2) - Tag F493), or the failure to have arrangements with outside sources for dialysis and dental services (§ 483.75(h) - Tag F500).  Pet. Pre-Hearing Br. at 2 n.2; CMS Pre-Hearing Br. at 2-3.  Accordingly, the ALJ found Vibra was not in substantial compliance with these participation requirements from July 27, 2015, through January 18, 2016, and sustained a CMP of at least $50 per day.  ALJ Decision at 1-2, 3-4.  Vibra also did not appeal the deficiency related to a failure to have a hospital transfer agreement (§ 483.75(n) - Tag F519), which was resolved through an independent dispute resolution process.  CMS Pre-Hearing Br. at 2 n.1; ALJ Decision at 1. 

⁷ We review the ALJ’s summary judgment decision de novo and, therefore, are not bound by the list of material facts set forth in the Order.  We further note that neither of the parties nor the ALJ limited their discussion of summary judgment to the facts set forth in the Order.

⁸ We note that neither party framed the issues in their respective briefs in accordance with the applicable standard of review.  CMS, for example, asserts that we should affirm the ALJ Decision because the ALJ’s factual findings are supported by “substantial evidence.”  See, e.g., CMS Response Br. at 2, 9, 14, 18.  The question on review of a grant of summary judgment, however, is not whether the ALJ made factual findings supported by substantial evidence, but whether any genuine dispute of material fact exists, and whether the prevailing party is entitled to judgment as a matter of law.  See Oak Ridge Ctr., DAB No. 2913, at 30 (2018).  While the inadequate briefing from both parties has hindered our review of this matter, we have been careful to apply the correct legal standards throughout this de novo decision.

⁹ Vibra also contends that the ALJ erred in upholding a finding of noncompliance under 42 C.F.R. § 483.25(h) at the immediate jeopardy level.  RR at 1-2, 19 (citing ALJ Decision at 17).  We agree that this case involved no allegation of noncompliance under section 483.25(h), which concerns accident hazards and prevention.  As CMS noted, the ALJ’s disconnected reference to section 483.25(h) is obviously a typographical error.  CMS Response at 18.  Our review of this matter is de novo and, in any event, the ALJ’s conclusions regarding CMS’s immediate jeopardy determination concerned only the deficiencies summarized at the outset of the decision.  See ALJ Decision at 2 (“I find that . . . the facility was not in substantial compliance with 42 C.F.R. §§ 483.13(b); 483.13(c); 483.20(k)(3)(i); 483.75; and 483.75(o)(1); [and] from July 27 through December 15, 2015, those deficiencies posed immediate jeopardy to resident health and safety . . . .”); see also ALJ Decision at 3 (highlighting in bold the five noncompliance findings and immediate jeopardy determinations at issue with no mention of section 483.25(h)).

¹⁰ As further discussed below, Vibra argues that some of the ALJ’s findings of noncompliance with section 483.13(c) were not raised by the state agency during the survey or by CMS during the ALJ proceedings, suggesting that Vibra was not provided adequate notice and a meaningful opportunity to be heard.  RR at 23-25.  All the noncompliance determinations set forth below were raised in the SOD or in CMS’s motion for summary judgment (MSJ at 14-16) giving Vibra adequate notice and a meaningful opportunity to respond.  See Golden Living Ctr. - Superior, DAB No. 2768, at 8 n.4 (2017) (holding that due process requirements were satisfied when CMS’s summary judgment motion advised the facility of the evidence and allegations supporting noncompliance determinations not specified in the statement of deficiencies).

¹¹ Notwithstanding this argument, Vibra’s own plan to return to substantial compliance under section 483.13(c) acknowledged that abuse allegations are to be reported “within 24 hours.”  CMS Ex. 4, at 15.  Still further, Vibra’s anti-abuse policy defines “immediately,” under the heading “FEDERAL ABUSE, NEGLECT AND EXPLOITATION DEFINITIONS,” to mean “‘as soon as possible,’ but not later than 24 hours.”  CMS Ex. 17, at 7-8.  We need not resolve these contradictions because we reject Vibra’s argument as a matter of law.

¹² Vibra argues that the ALJ’s determination regarding section 483.75 is contradicted by the “Board’s” interpretation of the regulation in Brookridge Life Care & Rehabilitation, DAB CR1538 (2006).  RR at 21-22.  Vibra is mistaken and its reliance on Brookridge is misplaced.  Brookridge is an ALJ decision and was never reviewed by the Board.  ALJ decisions are not precedent and are not binding on the Board or other ALJs.  Avalon Place Trinity at 13.  We need not address Vibra’s characterization of Brookridgeor the merits of that decision since neither the Board nor other ALJs are bound by it.  See Avalon Place Kirbyville, DAB No. 2569, at 11-12 (2014).

¹³ While it appears that a complete copy of Appendix PP as it existed in 2015 is no longer available on CMS’s website, the language quoted here can be viewed in CMS Transmittal 19, F520 (June 1, 2006), available at, https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R19SOMA.pdf or in Transmittal 168, F520 (Mar. 8, 2017), available at, https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R168SOMA.pdf.

¹⁴ In its reply, Vibra asserts that subsection 483.75(o)(2) is “not implicated here” and that CMS should not be permitted to “expand the scope” of noncompliance to include subsection 483.75(o)(2) at this late stage.  Reply at 4 & n.1.  We reject Vibra’s assertion because its noncompliance with subsection 483.75(o)(2) was at issue since the inception of this matter.  While the SOD cites to subsection 483.75(o)(1), its discussion of Vibra’s noncompliance specifically references and relies on the requirements of subsection 483.75(o)(2).  CMS Ex. 4, at 36-38 (discussing failures of Vibra’s QAA committee to adequately identify deficiencies and put systemic measures in place to protect residents following abuse allegations).  Moreover, in its motion for summary judgment, CMS alleged that Vibra was not in substantial compliance with the specific requirements of subsection 483.75(o)(2).  MSJ  at 18-20 (focusing on failures of the committee to respond to quality deficiency and develop appropriate plan of action).  And, while the ALJ Decision states that Vibra was not in substantial compliance with subsection 483.75(o)(1), the ALJ’s discussion makes clear that Vibra’s noncompliance was based on its deficiencies under subsubsection 483.75(o)(2).  ALJ Decision at 16-17 (concluding that Vibra’s committee failed to develop and implement appropriate plans of action to correct identified quality deficiencies).

¹⁵ We do not mean to suggest that CMS did not present other evidence supporting its determination that the noncompliance constitutes immediate jeopardy.  The declaration of the surveyor, for example, provided further information about the noncompliance identified in the SOD, including the ongoing failures of Vibra’s administration and QAPI Committee.  CMS Ex. 28.

¹⁶ We address Vibra’s noncompliance with section 483.75(o)(2) at the immediate jeopardy level, which began after July 27, 2015, in the discussion below.

¹⁷ We further reject Vibra’s argument that the ALJ erred by declining to review the timing of the survey as determined by the state agency.  RR 10-11 (citing ALJ Decision at 19).  Vibra suggests that the ALJ’s conclusion amounts to a failure to review its challenge to the duration of immediate jeopardy.  Id.  We disagree.  The state agency determined when to commence its investigation and survey; that was not a determination by CMS and is not among the “initial determinations” by CMS that ALJs (or the Board) have authority to review.  See 42 C.F.R. § 498.3(b) (setting out the types of initial determinations by CMS that ALJs may review).  In any event, the ALJ did review (as do we) Vibra’s challenge to the duration of immediate jeopardy as permitted under section 498.3(b)(14) (authorizing review of an initial determination by CMS as to the level of noncompliance where a successful challenge may affect the range of CMP amounts that CMS could collect).

¹⁸ The deficiency under section 483.75(o) was the only one determined to be at a scope and severity of Level L, indicating widespread noncompliance that poses immediate jeopardy to resident health and safety.  CMS Ex. 4, at 3; ALJ Decision at 3.  The SOD noted that the QAPI Committee failed to adequately identify and put in place measures to ensure that residents were protected following allegations of abuse; failed to review an incident of abuse that occurred on July 27, 2015, until October 1, 2015; failed to identify the deficient practices that allowed the alleged perpetrators to continue working in the facility after the CEO learned of the abuse allegation, placing all residents at risk for further abuse; and failed to provide an action plan to prevent any further occurrence.  CMS Ex. 4, at 3, 37-41.  Vibra did not present evidence disputing these facts.  See supra at 20-21.

¹⁹ While perhaps not an issue in this case, comparing CMP amounts imposed in prior cases to a current case is also problematic because under the current regulation, in effect since September 2016, the range of CMPs that CMS may impose is adjusted annually for inflation under 45 C.F.R. Part 102.  See 42 C.F.R. § 488.438(a) (Oct. 1, 2016); see also Interim Final Rule, Adjustment for Civil Monetary Penalties for Inflation, 81 Fed. Reg. 61,538, 61,563 (Sept. 6, 2016).

²⁰  “Repeated deficiencies are deficiencies in the same regulatory grouping of requirements found at the last survey, subsequently corrected, and found again at the next survey.”  42 C.F.R. § 488.438(d)(3).

²¹ Vibra Healthcare LLC is reported to be the “sister company” of Vibra Healthcare LLC II, which is the parent company of Vibra.  P. Ex. 7 (Fegan Decl., ¶ 2 & Attachment 1).

²² We further note that the prompt institution of corrective measures, while necessary to abate immediate jeopardy and return to substantial compliance, is not a relevant factor in assessing the reasonableness of a civil money penalty amount.  See Brian Center at 13.