Hales Corners Care Center, DAB CR5680 (2020)

DECISION

As explained below, I conclude that Petitioner Hales Corners Care Center was not in substantial compliance with program participation requirements from September 17 through October 11, 2018, and that its deficiency posed immediate jeopardy to resident health and safety.  I also conclude that the civil money penalties (CMPs) imposed for the noncompliance are reasonable.

I. Background

Petitioner Hales Corners Care Center (Hales Corners) is a long-term care facility located in Hales Corners, Wisconsin that participates in the Medicare program.  Following an annual certification and complaint survey by the Wisconsin Department of Health Services (WDHS) completed on September 20, 2018, the Centers for Medicare & Medicaid Services (CMS) concluded that the facility was not in substantial compliance with Medicare requirements, particularly those that govern food services and safe dietary practices.  CMS also determined that Petitioner's practices posed immediate jeopardy to resident health and safety.  Ultimately, CMS imposed CMPs in the total amount of $18,164.

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Petitioner requested a hearing before an administrative law judge to challenge CMS's determinations.  Request for Hearing (RFH).  This case was originally assigned to Judge Carolyn Hughes for a hearing and decision, but was then reassigned to me on May 11, 2020.

The Prehearing Order in this case directed the parties to submit, among other things, written direct testimony for each proposed witness, and explained that an in-person hearing would only be necessary if the opposing party requested an opportunity to cross-examine a witness.  Prehearing Order at 6; see HeartFlow, Inc., DAB No. 2781 at 16-18 (2017) (affirming that the use of written direct testimony for witnesses is permissible so long as the opposing party has the opportunity to cross-examine those witnesses).

Both parties have filed prehearing exchanges.1  CMS submitted written direct testimony for two proposed witnesses.  Petitioner did not submit any written direct testimony or propose any witnesses.  Neither Petitioner nor CMS has objected to the admission of any of the proffered exhibits, nor requested an opportunity to cross-examine any witness.  Therefore, a hearing for the purpose of cross-examination of a witness is unnecessary.  Prehearing Order at 6.  As an in-person hearing to cross-examine witnesses is not necessary, there is no need to further address CMS's motion for summary judgment.  The matter is ready for a decision on the merits.

In the absence of any objections, I hereby admit the following exhibits into the record:  CMS Exhibits (Exs.) 1-16 and P. Exs. 1-2.

II. Issues

The evidence of record in this case establishes that Petitioner's kitchen management and staff did not implement basic food safety requirements and sanitary practices.

The general issues to be resolved are whether, as a matter of law, such failures put the facility out of substantial compliance with Medicare program requirements, and if so, whether the immediate jeopardy determination was clearly erroneous, and whether the penalties imposed are reasonable.

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CMS has imposed CMPs of $8,444 per day for one day of immediate jeopardy and $405 per day for 24 days of substantial noncompliance that did not pose immediate jeopardy, for a total of $18,164.

III. Discussion

A.  Authorities

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

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

B  Findings of Fact, Conclusions of Law, and Analysis

In this case, the WDHS conducted an annual certification and complaint survey of Hales Corners from September 17, 2018 through September 20, 2018.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with the following program requirements:

42 C.F.R. § 483.60(i)(1)-(2), Tag F812 (Food Procurement, Store/Prepare/Serve – Sanitary) cited at scope and severity level "K" (pattern of noncompliance that poses immediate jeopardy to resident health and safety).

Specifically, CMS determined that Hales Corners was out of substantial compliance with the regulation because Hales Corners' kitchen staff served undercooked, unpasteurized eggs with runny yolks to residents on September 17, 2018.  CMS also determined that serving those eggs undercooked posed immediate jeopardy to resident health and safety by risk of salmonella poisoning.  CMS Ex. 2 at 1; CMS Ex. 11 at 1.  The egg service issue was remediated that same day.  CMS Ex. 2 at 7.

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CMS further determined that, once the immediate jeopardy was abated, Hales Corners remained out of substantial compliance for 24 days, from September 18, 2018 through October 11, 2018, based on two other deficiencies, involving dish sanitization and improper use of a handwashing sink.  CMS cited these deficiencies at the "F" level, demonstrating widespread noncompliance that caused no actual harm, with the potential for more than minimal harm.  CMS Ex. 1 at 8-10.  Following a revisit survey completed on October 25, 2018, CMS determined that Hales Corners had remedied all of the deficiencies and returned to substantial compliance on October 12, 2018, as stated in its Plan of Correction (POC).  CMS Ex. 3 at 2.

1. Petitioner was out of substantial compliance with Medicare requirements at 42 C.F.R. § 483.60(i)(1)-(2) because it served undercooked, unpasteurized eggs to residents in violation of its own policy, and Petitioner's noncompliance posed immediate jeopardy to resident health and safety.

Petitioner does not dispute that it was out of substantial compliance with the food safety regulation for serving undercooked, unpasteurized eggs.  Petitioner also does not dispute the related immediate jeopardy determination.  Nevertheless, having reviewed the record, I conclude that it supports both determinations.

Under 42 C.F.R. § 483.60(i), facilities must (1) procure food from sources approved or considered satisfactory by federal, state, or local authorities; and (2) store, prepare, distribute, and serve food in accordance with professional standards for food service safety.

As the Departmental Appeals Board has repeatedly explained, a facility's policy for implementing a regulatory requirement reflects the facility's own judgment about how best to achieve compliance.  Failing to comply with its own policies "can support a finding that the facility did not achieve compliance with the regulatory standard."  Bivens Mem. Nursing Home, DAB No. 2771 at 9 (2017); see Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 19 (2018) (ruling that in the absence of contrary evidence, it is reasonable to presume that the facility's policies reflect professional standards); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. at Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility's failing to comply with its own policies can constitute a deficiency).

The record shows that, during the survey, Petitioner's staff acknowledged it followed the U.S. Food and Drug Administration (FDA) Food Code, which prohibits serving "soft-cooked eggs that are made from raw eggs" to highly susceptible populations like "older adults" in a nursing home.  CMS Ex. 7 at 1-3; CMS Ex. 12 at 4 (indicating staff uses FDA Food Code for policies and procedures).  On September 17, 2018, however, WDHS surveyor, Erica Siefert, observed Petitioner's staff serving undercooked, unpasteurized

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eggs to five different residents.  CMS Ex. 2 at 2; CMS Ex. 12 at 1; CMS Ex. 15 at ¶¶ 8, 10.  Thus, based on the undisputed fact that Petitioner failed to comply with the FDA's Food Code for serving undercooked eggs, I conclude that Petitioner did not serve food in accordance with professional standards for food service safety and was therefore out of substantial compliance with section 483.60(i).

I also affirm CMS's determination that serving undercooked eggs posed immediate jeopardy to resident health and safety.  Immediate jeopardy exists if a facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.  The regulation does not require that a resident actually be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).  CMS's determination as to the level of a facility's noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is "clearly erroneous."  42 C.F.R. § 498.60(c).

Here, the surveyor testified that serving undercooked eggs placed multiple residents at risk of salmonella poisoning, which can cause "diarrhea, chills, fever, and dehydration, among other symptoms."  CMS Ex. 15 at ¶ 10.  The surveyor further testified that "[n]ursing home residents are especially vulnerable to the symptoms of salmonella poisoning, which in severe cases can be fatal."  Id.  This undisputed testimony supports the finding that the facility's service of undercooked eggs was likely to cause serious injury or harm to residents.  As noted, Petitioner does not dispute the immediate jeopardy determination, let alone argue that it was clearly erroneous.  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004) (observing that the "clearly erroneous" standard imposes on facilities a "heavy burden" to show no immediate jeopardy.).

2. Petitioner remained out of substantial compliance with Medicare requirements at 42 C.F.R. § 483.60(i)(1)-(2) because it failed to follow its own policies for using its handwashing sink and dishwashing machine.

I further find that the facility failed to comply with its policies for using its handwashing sink.  The facility acknowledged during the survey that it followed FDA food safety codes.  CMS Ex. 12 at 4.  However, the evidence establishes that Petitioner's kitchen staff did not comply with section 5-205.11 of the FDA Food Code, which prohibits using a handwashing sink for any purpose other than handwashing.  CMS Ex. 7 at 4.  Specifically, on September 17, 2018, the WDHS surveyor observed staff filling up pitchers of water for lunch service from a designated handwashing sink, and on September 20, 2018, a kitchen employee told the surveyor that filling water pitchers from the handwashing sink was acceptable because the water was clean.  CMS Ex. 2 at 10-11.

I also find that the facility failed to follow its own dishwashing policies and procedures.  The facility had dishwashing procedures to "ensure that all utensils, pots and pans,

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dishes, and eating utensils are properly washed and sanitized."  CMS. Ex. 10.  The facility used a "low temp, chemically sanitized dishmachine" and its procedures for using the machine included the following:

10.   PPM (Parts per Million) of the sanitizer, using the Precision Chlorine Test Paper Strips, must be recorded in the morning, afternoon, and evening on the Dishwasher Temperature and Sanitizer Log.  Test strips are located in the smoke box in dishwashing area.

1. After first rack of dishes are completed, open door of dishmachine, holding test strip, immediately put strip on surface of plate, pan, silverware, etc. and test.  Compare color of test strip to side of test strip vial and record the PPM.  Testing must be done after the first rack, midway through dishwashing, and after last rack of dishes to insure proper sanitization of the dishes.
2. Proper sanitization is 50-100 PPM.  If PPM is higher alert the Food Service Director, Maintenance, or Cook in charge.
3. If PPM is under 50 PPM, dishwashing process must be stopped until a dishmachine repair Person has fixed the problem.

CMS Ex. 10.  On September 19, 2018, the surveyor observed Dietary Aide-F running dishes through the dishwasher machine.  CMS Ex. 2 at 8.  The surveyor observed dishes, including pitchers and pans, on a rack drying on the clean side of the dishwasher.  Id. The surveyor interviewed Dietary Aide-F, who stated that she usually washes the dishes in the evening.  Id.  Dietary Aide-F was unable to describe the process for checking dishwasher sanitization functioning to the surveyor.  Id. at 8-9.  Dietary Aide-F also reported that the machine was already started before her coming on shift.  Id. at 9.

The surveyor then asked Food Service Director-B to show her the process for ensuring dishes are being sanitized.  CMS Ex. 2 at 9.Food Service Director-B ran a load of dishes including pans and a plate through the machine, then tested the water on the dishes after the machine had cycled through.  Id. The surveyor observed the indicator strip Food Service Director-B used remained white, indicating the chemical concentration level was below 50 ppm.  Id. Food Service Director-B ran the dishes through a second time and rechecked the water on the dishes after they had gone through the machine.  Id. The surveyor noted the indicator strip Food Service Director-B used remained white again.

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Id. Food Service Director-B told Dietary Aide-F to stop doing dishes and to redo the dishes that had already been done.  Id.

Food Service Director-B stated she would have to call maintenance to check the machine.  CMS Ex. 2 at 9.Later that morning, Food Service Director-B informed the surveyor that the dishwasher was now working.  Id. The surveyor observed Food Service Director-B take the indicator strip and dip it into the water inside the dishwasher.  Id. The surveyor observed the strip turn purple.  Id. The surveyor then asked Food Service Director-B if she could run a strip through the cycle.  Id. Food Service Director-B ran an indicator strip through a dishwashing cycle.  Id. The surveyor observed the indicator strip remained white after going through a dishwashing cycle.  Id. The surveyor reviewed the dishwasher temperature and sanitizing log and noted that, for September 19, 2018, the log was blank with no temperatures or chemical ppm documented.  Id.

The next day, on September 20, 2018, the surveyor interviewed Maintenance Director-G.  CMS Ex. 2 at 10.  Maintenance Director-G informed the surveyor that the rinse arm on the dishwasher machine was in disrepair because a plug was missing on the rinse arm, preventing it from building pressure.  Id.  Maintenance Director-G stated that sanitizer was still entering the machine, but was only going into the lower arm, not the upper arm.  Id.

Based on the above findings, I conclude that the facility remained out of substantial compliance with section 483.60(i) because its kitchen staff did not prepare and serve food in accordance with professional standards for food service safety.  The undisputed evidence establishes that Petitioner's kitchen staff did not comply with section 5-205.11 of the FDA Food Code governing handwashing sink policies.  Additionally, Petitioner's staff did not check the sanitization level of its dishwashing machine or record the readings in its log, as required by its own policy.  These failures created a risk of a spread of infection from unclean dishes and glasses.  CMS Ex. 15 at 3.

Petitioner does not dispute that it was out of compliance based on its failures to follow its own procedures for using its dishwashing machine or its handwashing sink.  Petitioner offers no testimony from members of the kitchen staff and does not deny or defend the staff's food service practices.  Petitioner argues instead that the issues were actually mitigated by September 20, 2018.  I reject that allegation for the reasons given below and instead find that the facility returned to substantial compliance no earlier than October 12, 2018, as stated in its own POC received by WDHS on October 15, 2018.  CMS Exs. 11, 14, 16.

3. CMS's determination as to the duration of the facility's substantial noncompliance is consistent with statutory and regulatory requirements.

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Once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist.  Asbury Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002); 42 C.F.R. § 488.454.

The facility must show that the incidents of noncompliance have ceased and that it has implemented appropriate measures to ensure that similar incidents will not recur.  Libertywood Nursing Ctr., DAB No. 2433 at 15 (2011) (citing Life Care Ctr. of Elizabethton, DAB No. 2367 at 16 (2011)), aff'd, Libertywood Nursing Ctr. v. Sebelius, 512 F. App'x 285 (4th Cir. 2013); Hermina Traeye Mem'l Nursing Home, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation "acceptable" to CMS showing that it was in substantial compliance and was capable of remaining in substantial compliance on the earlier date); Cross Creek Care Ctr., DAB No. 1665 (1998).

A facility's return to substantial compliance must usually be established through a resurvey.  See 42 C.F.R. § 488.454(a); Ridgecrest, DAB No. 2493 at 2-3.

On October 1, 2018, WDHS notified Petitioner of the survey findings from September 17, 2018 through September 20, 2018, and provided a Statement of Deficiencies.  WDHS clarified that the immediate jeopardy issue was abated on September 17, 2018.  However, the dish sanitization and handwashing sink level-F deficiencies were still present and had not been corrected by September 20, 2018, the last day of the survey.  WDHS asked that Petitioner submit a POC.  CMS Ex. 1.  On October 15, 2018, WDHS received a POC from Petitioner which stated "corrective action was completed by 10/12/2018."  CMS Ex. 11.

After receiving the POC, WDHS surveyor Sergio Torres conducted a resurvey of the facility on October 25, 2018, and determined that all corrective actions had been taken.  Petitioner Hales Corners Care Center was found back in substantial compliance with Medicare program participation requirements effective October 12, 2018, the date provided in the POC.  CMS Exs. 11, 14, 16.

Petitioner now alleges that it was in substantial compliance by September 20, 2018, rather than October 12, 2018, stating that the October 12, 2018 date given in its POC was only an estimate of when staff training was completed.  Petitioner argues it stopped using its dishmachine "immediately" and then initiated manual dishwashing per its policy, which, according to Petitioner, "mitigated" the "potential for wide spread harm."  RFH.  Additionally, Petitioner contends that it ceased using the handwashing sink for drinking

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water immediately and that the food service director "immediately" reviewed proper procedures for filling pitchers from the prep sink with "all staff present."  Id.

Petitioner provides insufficient documentary evidence and testimony to support that it returned to substantial compliance earlier than October 12, 2018.  Petitioner submitted two documents, but neither shows when the facility returned to substantial compliance.  The first document, dated September 21, 2018, merely provides instructions for using the dishwashing machine.  P. Ex. 2.  The other document contains undated signatures from (presumably) staff acknowledging that the handwashing sink must be used for handwashing only.  Id.  As noted, the facility was cited for failing to follow its own policies, including checking the sanitization level of the dishwashing machine.  Petitioner has provided no evidence to show when it reviewed the relevant policies with its staff, so has no support for its claim that it returned to substantial compliance earlier.  If Petitioner did not retrain all of its staff until October 12, 2018, as it acknowledges, then it did not return to substantial compliance before that date.  Moreover, the two level-F deficiencies are not the sort of problems that can be corrected quickly without extensive staff training.

The only documentary evidence provided by Petitioner on point is its POC, which states that all corrective actions were taken by October 12, 2018.  CMS Ex. 11.  It is the facility's burden to show that it returned to substantial compliance on a date earlier than that determined by CMS.  Asbury Ctr., DAB No. 1815 at 19-20; see also 42 C.F.R. § 488.454(a).  The facility has not met its burden of establishing that it returned to substantial compliance any earlier than October 12, 2018.

4. The CMP amounts imposed are reasonable.

Petitioner seeks a reduction of the total CMP imposed by arguing that it returned to substantial compliance earlier than October 12, 2018.  Petitioner does not expressly argue that the per-day CMP amounts imposed are unreasonable under the regulatory factors that may be considered.  42 C.F.R. § 488.438(f); Coquina Ctr., DAB No. 1860 at 32 (2002) (providing that unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it.).

Petitioner does point out that the facility has been "a five-star facility" and that "three of the previous five surveys were deficiency-free."  RFH.  To the extent Petitioner raises these points to justify reducing the per-day CMP amounts imposed, I find them unavailing.  Petitioner provides no evidence to support its compliance history.  Moreover, Petitioner's culpability justifies the per-day CMP amounts imposed, as the facility's noncompliance was based on its failure to follow its own policies.  Petitioner also does not argue that its financial condition justifies reducing the CMP amounts.  Finally, for the non-immediate jeopardy level noncompliance, CMS maintains that the undisputed facts establish a regulatory basis for imposing the per-day penalty for 24 days and that the per-

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day $405 amount is reasonable because it falls in the bottom 5% of the permissible $107 to $6,417 per-day penalty range.  I agree.  For these reasons, I find the per-day CMP amounts imposed to be reasonable.

IV. Conclusion

I find that the record is sufficiently developed and the only reasonable conclusion that can be drawn from the undisputed facts is that, from September 17, 2018 through October 11, 2018, Hales Corners Care Center was not in substantial compliance with Medicare program requirements and that, on September 17, 2018, its noncompliance posed immediate jeopardy to resident health and safety.  I also affirm as reasonable the penalties imposed by CMS:  $8,444 per day for one day of immediate jeopardy and $405 per day for 24 days of substantial noncompliance that did not pose immediate jeopardy.

• 1. In response to a show cause order for failing to file an exchange timely, Petitioner moved for leave to file its exchange out of time, explaining that this is its first appeal and that it "did not realize any further documentation was necessary" because it "believed that [it] had provided any necessary information and justification with the request for appeal."  Petitioner's Motion for Leave (June 27, 2019).  I find good cause to grant Petitioner's motion and accept its exchange out of time.