Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Sarasota Memorial Nursing and Rehabilitation Center
Centers for Medicare & Medicaid Services.
Docket No. C-21-127
Decision No. CR5949
Sarasota Memorial Nursing and Rehabilitation Center (Petitioner or facility), a skilled nursing facility (SNF), failed to honor a properly executed “Do Not Resuscitate” (DNR) order for Resident 1 because the DNR order was not placed in the facility’s advance directives binder. At approximately 9:05 a.m., on March 20, 2020, a certified nurse assistant found Resident 1 unresponsive. Facility staff initiated cardiopulmonary resuscitation (CPR) and called 911 after staff was unable to locate the resident’s DNR order in the advance directives binder. Emergency Medical Services (EMS) personnel arrived and continued resuscitation efforts. Facility staff found the DNR order, and EMS personnel discontinued CPR and documented Resident 1’s death at 9:34 am.
The Centers for Medicare & Medicaid Services (CMS) found that Petitioner had an isolated instance of noncompliance that posed immediate jeopardy to resident health and safety in violation of the Medicare participation requirement for SNFs at 42 C.F.R. § 483.10(c)(6) and (g)(12) (by cross reference to 42 C.F.R. § 489.102(a)(2)). As a result, CMS imposed a $21,393 per-instance civil money penalty (CMP) on Petitioner.
Petitioner admits that it had policies and procedures in place that required the admitting nurse to place Resident 1’s DNR order in the advance directives binder upon admission, and a social worker to verify that the admitting nurse placed the DNR order into the advance directives binder. Petitioner argues that, despite training in and knowledge of the DNR policy, the admitting nurse and the social worker made an error, which resulted in no injury to Resident 1. Petitioner further argues that the human error was not the result of any systemic issue or noncompliance and that it did everything it could to prevent this type of incident from occurring. Lastly, Petitioner asks for a reduction of the amount of the CMP because the $21,393 CMP imposed is excessive and unwarranted.
As I explain below, Petitioner was in substantial noncompliance with Medicare program participation requirements. Accordingly, I sustain the imposition of the CMP. However, based on relevant statutory and regulatory factors, I reduce the CMP amount to $10,500.
I. Legal Framework
The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria. 42 U.S.C. § 1395c. Post-hospital care includes extended care services provided at an SNF. 42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).
For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents, but is not primarily engaged in the care and treatment of mental diseases. 42 U.S.C. §§ 1395x(j), 1395i-3(a)(1). Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary). 42 U.S.C. §§ 1395cc(a), 1395x(u). Further, a participating SNF must meet a variety of ongoing requirements related to how it provides services, maintains the rights of its residents, and administers its facility. 42 U.S.C. § 1395i-3(a)(3), (b)-(d); 42 C.F.R. pt. 483, subpt. B.1
When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.” 42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1). “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301. To maintain “substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301.
Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels. One level is comprised of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not. 42 U.S.C. § 1395i-3(h)(1). “Immediate jeopardy” exists when “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.
The Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance. 42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10. These surveys can be unannounced surveys that occur at least once every 15 months or can be in response to a complaint. 42 U.S.C. § 1395i-3(g). When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency. See 42 C.F.R. § 488.404(a)-(b).
One such remedy CMS may impose is a CMP. 42 U.S.C. § 1395i-3(h)(2)(B)(ii). CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance. 42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a). For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows: $2,233 to $22,320 for per-instance CMPs; $112 to $6,659 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).
If CMS imposes a CMP based on a noncompliance determination, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF). 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 488.434(a)(2)(viii), 498.3(b)(13)-(14); see also 5 U.S.C. §§ 554, 556. Either the SNF or CMS may request Departmental Appeals Board (DAB) review of an ALJ’s decision. 42 C.F.R. § 498.80.
When an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements. If CMS meets this threshold, the SNF must prove substantial compliance by a preponderance of the evidence to prevail. Hillman Rehab. Ctr., DAB No. 1611 at 8
(1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson,129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001). If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2).
II. Background and Procedural History
Petitioner is an SNF that operates in Sarasota, Florida. From July 6 to July 8, 2020, the Florida Agency for Health Care Administration (state agency) conducted an infection control focused visit and complaint survey of Petitioner’s facility. CMS Exhibit (Ex.) 1 at 1. The state agency subsequently issued a Statement of Deficiencies finding that the facility was not in substantial compliance from March 20, 2020 through March 21, 2020, with the Medicare requirements listed in Tag F-578, which include, in pertinent part, 42 C.F.R. § 483.10(c)(6) (right to refuse treatment) and 42 C.F.R. § 483.10(g)(12)(i)-(v) (advance directives) at a scope and severity level of “J” (i.e., immediate jeopardy to resident health and safety) related to Resident 1. CMS Ex. 1.
CMS issued an initial determination on September 2, 2020 and imposed enforcement remedies based on the results of the July 8, 2020 survey. CMS stated in the initial determination that the state agency identified past substantial noncompliance with the requirements for SNFs on March 20, 2020, and that such noncompliance immediately jeopardized the health and safety of residents at the facility. CMS Ex. 3 at 1. CMS imposed a $21,393 per-instance CMP on Petitioner “for noncompliance identified as immediate jeopardy cited at [Tag] F578J.” CMS Ex. 3 at 2.
On November 2, 2020, Petitioner requested a hearing before an ALJ to dispute the September 2, 2020 initial determination. On November 3, 2020, the Civil Remedies Division issued my Standing Prehearing Order. In that Order, I directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.
In compliance with the Order, CMS filed a prehearing exchange, which included a combined motion for summary judgment and prehearing brief (CMS Br.), and 10 proposed exhibits (CMS Exs. 1-10). One of the proposed exhibits was a declaration from a proposed witness (CMS Ex. 8). Petitioner timely filed an exchange consisting of a cross-motion for summary judgment and prehearing brief (P. Br.), and 9 proposed exhibits (P. Exs. 1‑9). Four of the proposed exhibits were declarations from proposed witnesses (P. Exs. 2-4, 6).
III. Decision on the Record
Neither party objected to the proposed exhibits, and neither party requested to cross-examine any of the proposed witnesses. Absent objections from the parties, I admit CMS Exs. 1-10 and P. Exs. 1-9 into the record. See Order ¶ 9; CRDP § 14(e). Further, as neither party requested to cross-examine any of the proposed witnesses, a hearing is not necessary and I issue this decision based on the written record. See Order ¶ 12 (stating that “[a] hearing to cross-examine witnesses will be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine); CRDP §§ 16(b), 19(b), (d).
1) Whether Petitioner failed to substantially comply with the requirements of 42 C.F.R. § 483.10(c)(6), (g)(12); and
2) Whether the $21,393 per-instance CMP is appropriate based on the factors in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I).
V. Findings of Fact and Conclusions of Law
My findings of fact and conclusions of law are in bold and italics.
1. Resident 1 had a valid DNR order upon admission to the facility on March 16, 2020. Petitioner’s staff obtained a copy of the DNR order but failed to place it in the facility’s advance directives binder.
Resident 1 was admitted to a hospital on March 13, 2020, and admitted to Petitioner’s facility from the hospital on March 16, 2020. CMS Ex. 4 at 10, 16. At the time of admission, Resident 1 was a 79-year-old woman with diagnoses of pneumonia, urinary tract infection, history of sepsis, cerebrovascular accident with right sided weakness, seizures, hypertension, anxiety, and chronic low back pain. CMS Ex. 2 at 5; CMS Ex. 4 at 10.
Resident 1 had a State of Florida DNR order that she and her physician signed on February 13, 2012. CMS Ex. 4 at 2. The DNR order expressly stated that: “Based upon informed consent, I, the, undersigned, hereby direct that CPR be withheld or withdrawn.” CMS Ex. 4 at 2. The facility’s advance directives policy states that its staff “will not use cardiopulmonary resuscitation and related emergency measures to maintain life functions on a resident when there is a DO NOT RESUSCITATE ORDER in effect.” CMS Ex. 5 at 1. Facility procedure first states: “Do Not Resuscitate orders must be signed by the residents (sic) attending physician on the Goldenrod DNR order, the form is kept on the
unit assigned to the resident in a green book on the desk.” CMS Ex. 5 at 1. The procedure then states that “[a] Do Not Resuscitate Order is placed in the EMR [electronic medical record]” and “[t]he form is signed by the physician and resident.” CMS Ex. 5 at 1. The procedure also states: “Do Not Resuscitate orders (DNRO) will remain in effect until the resident provides the facility with a signed and dated request to end the DNR order.” CMS Ex. 5 at 1. The facility only uses state approved DNR order forms. CMS Ex. 5 at 1.
Petitioner obtained a copy of Resident 1’s DNR order at the time of admission. P. Ex. 3 ¶ 6; P. Ex. 6 ¶ 6; CMS Ex. 4 at 4 (progress note entered on March 17, 2020 at 2:02 a.m. by admitting nurse that “Dnr in place.”); see CMS Ex. 4 at 10; CMS Ex. 6 at 3. The admitting nurse testified in this proceeding that she “immediately placed a copy of Resident 1’s DNR into the [designated advance directives] Binder. P. Ex. 3 ¶ 8.
However, on March 18, 2020, the facility social worker attempted to locate Resident 1’s DNR order in the advance directives binder, but “she could not locate it.” CMS Ex. 6 at 4. The social worker indicated that she “got sidetracked and did not follow through with established facility procedure” to try and locate the DNR order. CMS Ex. 6 at 4; P. Ex. 6 ¶ 7. The social worker admitted that she was very familiar with Petitioner’s policies on DNRs, and that the mistake “was not caused because [she] did not know the policies and procedures.” P. Ex. 6 ¶ 7. The admitting nurse testified that she did not know why the DNR order was not in the advance directives binder. P. Ex. 3 ¶ 10.
The Director of Nursing (DON) testified that she had “no direct involvement in the circumstances regarding the resident . . . [but that she was] aware that Resident 1 was admitted to the facility on March 16, 2020. The DON further testified that, in accordance with [Petitioner’s] standard operating procedure, the admitting nurse prepared the initial paperwork at the time of the admission, including obtaining an official executed and dated do-not-resuscitate (DNR) form that was to be placed immediately into [Petitioner’s] designated advance directives Binder.” P. Ex. 2 ¶ 5. Further, “[t]he binder is audited after each and every new admission by a social worker to ensure each new resident’s DNR or other advance-directive form, if in existence, has been placed into the Binder.” P. Ex. 2 ¶ 10b. In her opinion, the failure of staff to place Resident 1’s DNR into the binder and the failure of staff to ensure that it was there “was the result of two human errors.” P. Ex. 2 ¶ 17.
The facility’s investigation also concluded that staff simply made errors related to updating the advance directive binder with Resident 1’s DNR order.
Investigation concluded although the licensed staff and social workers were knowledgeable on the process, the admitting nurse did not follow the admission procedure and failed to transfer the advance directives to the advance directives
binder. Additionally, although she expressed being knowledgeable and educated about the facility 48 hours baseline process related to advanced directives, the resident’s social worker did not follow the facility procedure as established.
CMS Ex. 6 at 4.
2. At approximately 9:05 a.m. on March 20, 2020, facility staff found Resident 1 unresponsive and, after checking the advance directives binder and not finding Resident 1’s DNR order, commenced resuscitation efforts. Shortly thereafter, facility staff called EMS. Upon arrival, EMS personnel took over the resuscitation efforts. Facility staff then located Resident 1’s DNR order and EMS personnel discontinued CPR, documenting Resident 1’s time of death at 9:34 am.
A March 20, 2020 progress note written by a facility nurse summarized the events involving Resident 1’s death:
At 9:05am this nurse was alerted by the aid that the patient was non responsive. . . . This nurse did a sternal rub and was not able to arouse the patient. . . . The aid attempted to obtain vitals and none were noted. Two nurses confirmed there was no apical pulse. Supported measures were initiated while the staff confirmed code status. This nurse phoned 911. Upon EMS arrival an EKG confirmed asystole. Code status was confirmed and supportive measures were discontinued. Time of death was called at 9:34am.
CMS Ex. 4 at 8. The facility investigation findings were consistent with the progress note; however, the investigative report provided additional details. The report stated that “life saving measures” were initiated “around 9:11 am while the staff continued looking for the resident’s advance directives.” CMS Ex. 6 at 3. The investigative report also specified that EMS arrived at 9:23, and continued “their supportive measures” until facility staff located Resident 1’s DNR order. CMS Ex. 6 at 3. EMS ceased life-saving measures and called the time of death at 9:34 am. CMS Ex. 6 at 3.
The DON testified that Resident 1 “suffered a cardiac incident and coded.” P. Ex. 2 ¶ 7. When Resident 1 coded, one floor nurse immediately checked the advance directives binder for a DNR order, but it was not there. P. Ex. 2 ¶ 7. The DON further testified:
When there was no DNR in the Binder, a second floor nurse began resuscitation efforts on Resident 1, which were taken
over by EMS upon their arrival. Meanwhile, a third floor nurse, recalling the fact that Resident 1 had provided the facility with a DNR upon her admission, went to look for, and found, Resident 1’s DNR. Immediately upon finding Resident 1’s DNR, all resuscitation efforts ceased.
P. Ex. 2 ¶ 8.
3. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(c)(6), (g)(12) because it failed to honor Resident 1’s legally executed DNR order.
The Social Security Act (Act) requires SNFs to “protect and promote the rights of each resident, including . . . the right to be fully informed in advance about care and treatment, to be fully informed in advance of any changes in care or treatment that may affect the resident’s well-being, and . . . to participate in planning care and treatment or changes in care and treatment.” 42 U.S.C. § 1395i-3(c)(1)(A)(i). The Act also requires SNFs to maintain written policies and procedures concerning advance directives and to, among other things, “document in a prominent part of the individual’s current medical record whether or not the individual has executed an advance directive.” 42 U.S.C. §§ 1395i-3(c)(1)(E)., 1395cc(f)(1)(B). The Act defines “advance directive” as a “written instruction, such as a living will or durable power of attorney for health care, recognized under State law . . . and relating to the provision of such care when the individual is incapacitated. 42 U.S.C. § 1395cc(f)(3); see also 42 C.F.R. § 489.100.
To effectuate the requirements of the Act, the Secretary promulgated the resident rights regulation that states “the resident has the right to be informed of, and participate in, his or her treatment, including the right to request, refuse, and/or discontinue treatment, to participate in or refuse to participate in experimental research, and to formulate an advance directive.” 42 C.F.R. § 483.10(c)(6) 2 (emphasis added). Further, the resident rights regulation requires that SNFs comply with the requirements specified in 42 CFR part 489, subpart I (Advanced Directives), which states that SNFs “must maintain written policies and procedures concerning advance directives with respect to all adult individuals receiving medical care, or patient care in the case of a patient in a religious nonmedical health care institution.” 42 C.F.R. §§ 483.10(g)(12), 489.102(a). In particular, SNFs must:
Document in a prominent part of the individual’s current medical record, or patient care record in the case of an individual in a religious nonmedical health care institution, whether or not the individual has executed an advance directive.
42 C.F.R. § 489.102(a)(2).
The facts related to Resident 1’s DNR order and Petitioner’s improper efforts to resuscitate Resident 1 are not in dispute. However, Petitioner maintains that CMS’s findings of noncompliance were due to a “single incident involving human error by two well-trained [facility] personnel.” P. Br. at 1, 9. Petitioner asserts that this singular incident is “not the result of any systemic issue or noncompliance on [the facility’s] part, when [the facility] did everything it could to prevent this type of incident from occurring.” P. Br. at 11. Petitioner argues that the federal requirements regarding long-term skilled nursing facilities do not contemplate that a facility “will be entirely free of all error,” and that “despite training and knowledge of the DNR policy, the admitting nurse (who believes she placed the DNR in the Binder) and the social worker (who admits she failed to verify that the DNR was placed in the Binder) made an error.” P. Br. at 9. Petitioner sums up its argument as follows:
While it is generally recognized that there is no “ ‘human error’ exception to the 13 regulatory requirements,” . . . the facts underlying this case establish that [Petitioner] was in substantial compliance with the Participation Requirements because it did everything it could to ensure that every resident’s DNR or other advance directive was immediately placed into the Binder upon admission. The failure to immediately locate Resident 1’s DNR in the Binder was an isolated, never-before event, that occurred because two experienced, well-trained employees made mistakes despite explicit policies and detailed and regular training implemented by SMNRC which were specifically designed to prevent this error.
P. Br. at 12-13.
Petitioner’s arguments are unavailing. As discussed above, the record is clear that Resident 1 provided a valid State of Florida DNR order to facility staff during her admission on March 16, 2020. CMS Ex. 4 at 2-3, 10. Petitioner failed to prominently post the DNR order in Resident 1’s medical records or its advance directive binder. While Petitioner believes that it was in substantial compliance at all relevant times because “it did everything possible to make certain that DNRs for every patient [are]
immediately place[d] in the Binder upon the admission of each new patient,” it is not disputed that, on March 20, 2020, the fourth day after her admission, Resident 1’s DNR order was located in the resident’s admissions paperwork and not in the advance directives binder as required by Petitioner’s policy and procedure regarding DNRs. P. Br. at 10; CMS Ex. 6 at 3.
I accept the opinion of the state agency surveyor who testified that the issue here is not simply a problem with human error, but rather that the “facility’s system failed on two levels when the admitting nurse and the social worker failed to follow facility policy and ensure that Resident 1’s DNR order was placed in the advance directives binder.”3 CMS Ex. 8 ¶ 14. Further, she testified that both the Administrator and the DON were responsible for ensuring that staff followed DNR policies and procedures, which did not occur here. The advance directives binder became such an integral part of the facility’s DNR process that simple human errors made the binder procedure “especially dangerous.” CMS Ex. 8 ¶ 15. The errors of both the admitting nurse and the social worker resulted in treatment being administered against the explicit wishes of Resident 1 during a cardiac or respiratory arrest emergency, a violation of the facility’s policy as well as Resident 1’s DNR. CMS Ex. 5 at 1. As the state agency surveyor testified:
Residents make advance directives so they can make their wishes about end-of-life care known to medical staff in the event that they are unable to communicate their wishes. Creating an advance directive is a resident’s right. By signing her DNR form, Resident 1 communicated her desire to not be resuscitated.
CMS Ex. 8 ¶ 18.
Petitioner’s actions created a risk for more than minimal harm to Resident 1. The state agency surveyor testified that performing CPR on an individual “can lead to intense pain and injuries, including broken ribs . . . [or] unwanted intubation or ventilation.” CMS Ex. 8 ¶ 17. Even after CPR is administered, a resident can experience “brain damage . . .or [the resident] could die again.” CMS Ex. 8 ¶ 17. Having CPR performed “after dying is emotionally traumatizing for residents who . . . made the decision to have a DNR in place.” CMS Ex. 8 ¶ 17. As similarly explained by an ALJ in a case also involving a facility that attempted to resuscitate a resident against a DNR order:
I take notice that cardiopulmonary resuscitation is in many cases a procedure that can cause great pain and distress to an
individual. Ribs are often broken when manual CPR is administered. The electrical shock administered by an [automated external defibrillator] can be quite painful. And, resuscitation, even if successful, can in many cases only prolong an individual’s suffering. There is also the distress that may be caused to an individual’s family by the efforts of resuscitation and their aftermath. For these reasons it is critical that a facility honor a resident’s DNR request. Noncompliance with one of these requests is likely to cause substantial physical and psychological harm.
Cascade-Abilene Health Servs., DAB CR4826 at 3 (2017).
CMS has put forth sufficient evidence to establish substantial noncompliance with 42 C.F.R. § 483.10(c)(6), (g)(12). Petitioner has not presented evidence sufficient to rebut CMS’s prima facie case. Resident 1 had a right not to be subjected to life saving efforts, like CPR. Petitioner failed to ensure that right when the admitting nurse did not transfer Resident 1’s DNR order from the admissions paperwork to the advance directives binder, and the social worker did not follow through to ensure that Resident 1’s DNR order was placed into the advance directives binder by the admitting nurse. A single failure—even caused by human error—to honor a resident’s right to refuse treatment can result in a finding of substantial noncompliance. See Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 16–19 (2018) (upholding ALJ determination that facility was out of substantial compliance where staff disregarded a single resident’s refusal of treatment); Cascade-Abilene Health Servs., DAB CR4826 at 3-4 (upholding a deficiency based on facility staff attempting to resuscitate a resident with a DNR, stating that “[t]hese undisputed facts plainly describe a violation of the resident’s right not to be resuscitated. In and of themselves they establish substantial noncompliance with regulatory requirements.”).
Although I recognize that Petitioner had procedures in place and appears to have trained its staff, it is ultimately responsible for the acts and omissions of its employees. Resident 1 had the right to refuse treatment. Petitioner violated that right because it did not properly and prominently document Resident 1’s DNR order. Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(c)(6), (g)(12).
4. CMS’s finding of immediate jeopardy is outside the scope of my review.
Petitioner argues that CMS’s immediate jeopardy determination is clearly erroneous and constitutionally defective. P. Br. at 16-20. However, a facility may only challenge CMS’s scope and severity findings (which include immediate jeopardy) if: 1) a successful challenge would affect the range of the CMP; or 2) CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide
training program. 42 C.F.R. § 498.3(b)(14), (d)(10); see also Cedar Lake Nursing Home, DAB No. 2344 at 9 (2010); Evergreen Commons, DAB No. 2175 at 2 (2008); Aase Haugen Homes, DAB No. 2013 at 17-19 (2006).
In the present case, I have no authority to review CMS’s immediate jeopardy determination. CMS imposed a per-instance CMP of $21,393. For a per-instance penalty, the regulations only provide a single penalty range ($2,233 to $22,320), without regard to the level of noncompliance. 42 C.F.R. § 488.438(a)(2)(providing original CMP amounts before statutory inflation adjustments); see also 45 C.F.R. § 102.3 (2020). Therefore, the finding of immediate jeopardy does not affect the range of the CMP and is therefore not appealable to an ALJ. See NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014); see also Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 24 (2011). Further, the initial determination does not make a finding of substandard quality of care that resulted in the loss of approval of a nurse aid training program.
5. The $21,393 per-instance CMP that CMS imposed is not reasonable under relevant statutory and regulatory factors. My analysis of the factors indicates than a $10,500 CMP is appropriate.
CMS imposed a single per-instance CMP in the amount of $21,393 on Petitioner. CMS Ex. 3 at 2. When determining whether a CMP amount is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I). The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors listed in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies. See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).
The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range. 42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).
In the present matter, Petitioner argues that: 1) this incident was the first time Petitioner failed to follow a DNR; 2) Resident 1 is unlikely to have suffered from the mistake; 3) the deficiency is the result of human error and not a result of any systematic failure on behalf of the facility; and 4) the amount of the CMP is nearly the maximum amount.
P. Br. at 20-21. Based on the regulatory categories, Petitioner appears to argue that its culpability is minimal because there was a simple lapse in employee diligence, and the facility itself is acting appropriately. Further, Petitioner argues that this is the first time it violated 42 C.F.R. § 483.10(c)(6), (g)(12)(i)-(v), which, it argues, should be taken into account. Petitioner did not indicate that it was financially unable to pay the CMP.
CMS asserts that the penalty amount is reasonable based on Petitioner’s noncompliance. CMS Br. at 13. In support, CMS notes that the $21,393 amount falls within the permissible range under 42 C.F.R. § 488.438(a)(2) and 42 C.F.R. § 102.3 (2020). CMS also argues that Petitioner has had four F-level deficiencies in the past, that the underlying facts demonstrate the seriousness of the deficiency, which posed immediate jeopardy to Resident 1, and that Petitioner is culpable for the actions of its employees. CMS Br. at 13.
As discussed above, I have determined that Petitioner was noncompliant with 42 C.F.R. § 483.10(c)(6) and (g)(12). CMS had a basis for imposing the CMP as a remedy for the noncompliance. Accordingly, I discuss the relevant regulatory factors regarding CMP amounts below:
Facility’s History of Non-Compliance: Petitioner has a history of noncompliance over previous years. Since 2012, Petitioner failed to be in substantial compliance with program requirements for surveys conducted in 2012, 2013 and, most recently, in 2016 and 2018. CMS Ex. 9 at 1-2; CMS Ex. 10 at 2-4. The most serious deficiencies cited in prior surveys were at the scope and severity level F (widespread deficiencies with no actual harm to residents, but the potential for more than minimal harm) and CMS allowed Petitioner to correct the deficiencies without imposing an enforcement remedy. CMS Ex. 9 at 1-2; CMS Ex. 10 at 2-4. Although Petitioner has a past history of noncompliance, I do not find that this history supports a CMP nearly at the maximum amount of the penalty range.
Scope and Severity of Deficiencies and Relationship Between Deficiencies: I find the incident in this case to be of significant severity. CMS determined that it was at the immediate jeopardy level; a determination that I cannot review. However, the record shows that Petitioner’s staff physically touched and caused EMS personnel to touch Resident 1 in a manner that could cause significant harm. Upon discovering that Resident 1 was non-responsive on March 20, 2020, Petitioner’s staff conducted a sternal rub, but was unable to arouse her. CMS Ex. 4 at 8. Life saving measures were initiated while Petitioner’s staff confirmed Resident 1’s code status. CMS Ex. 4 at 8.Resident 1 received approximately 20 minutes of CPR, including by EMS personnel, because the DNR order was not placed in the advance directives book as required by Petitioner’s policy. Such measures are physically invasive and, had Petitioner’s staff or EMS revived Resident 1 against her wishes, Resident 1 could have been in a worse health situation than before the incident.
Culpability: I conclude that Petitioner is culpable in this case because Petitioner is ultimately responsible for the acts and omissions of its employees. However, the record reflects that, while Petitioner’s system for documenting DNR orders at admission failed and was subject to failure based on human error, I conclude that Petitioner had a system in place that was to double check that DNR orders were readily accessible to staff. Further Petitioner’s staff appears to have been trained on the system. CMS Exs. 5, 11; P. Exs. 2-4, 6. This also appears to be an isolated incident, which Petitioner self-reported. CMS Exs. 1-2, 5, 6; P. Exs. 2, 4.
Financial Condition of the Facility: Petitioner presents no evidence of its financial condition. Therefore, this is not a factor requiring further consideration.
CMP Amount: A per-instance CMP of $21,393, nearly the maximum allowed, is not reasonable based on the factors considered above. Therefore, I reduce the CMP to $10,500, or approximately half the originally imposed amount.
For the reasons set forth above, I sustain CMS’s finding that Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(c)(6) and (g)(12), but reduce the per-instance CMP to $10,500.
Scott Anderson Administrative Law Judge
1. All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.
- back to note 1 2. CMS revised part 483 regulations concerning SNF conditions of participation in 2016, including the resident’s rights regulation found at 42 C.F.R. § 483.10. 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections). The planning and implementing care regulation currently promulgated in 42 C.F.R. § 483.10(c)(6) was formerly found in 42 C.F.R. § 483.10(b)(4). In assessing compliance under § 483.10(c)(6) in this case, I consider case decisions analyzing the former § 483.10(b)(4).
- back to note 2 3. The state agency surveyor has been a registered nurse since 1988 and has significant experience in a variety of health care settings, including SNFs where she served as an assistant director of nursing at two different facilities. CMS Ex. 8 at ¶¶ 1-7.
- back to note 3