Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Signature Healthcare of East Louisville,
(CCN: 18-5350),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-14-1127
Decision No. CR5131
DECISION
Petitioner, Signature Healthcare of East Louisville, was not in substantial compliance with program participation requirements from February 12 through March 28, 2014, based on violations of 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282
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following enforcement remedies, which are reasonable: a $5,800 per day civil money penalty (CMP) effective February 12 through March 9, 2014; a $200 per day CMP effective March 10 through March 28, 2014; and a denial of payments for new admissions (DPNA) for the period March 19 through March 28, 2014.
I. Background
Petitioner is located in Louisville, Kentucky, and participates in Medicare as a skilled nursing facility (SNF) and Medicaid as a nursing facility (NF). On March 7, 2014, the Kentucky State Survey Agency (state agency) completed a survey of Petitioner and found Petitioner not in substantial compliance with program participation requirements due to violations of 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282), 483.65 (Tag F441), 483.75 (Tag F490), and 483.75(o) (Tag F520), all alleged by the surveyors to have posed immediate jeopardy to Petitioner’s residents. Joint Stipulations of Undisputed Facts (Jt. Stip.) ¶¶ 1-4; Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1 at 21-28, 44-59, 62-65, 74-78. The survey also found noncompliance, which is not challenged by Petitioner, based on violations of 42 C.F.R. §§ 483.10(k), (l) (Tag F174) (scope and severity (s/s) D
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CMS notified Petitioner on March 17, 2014, that it was imposing the following enforcement remedies based on the March 7, 2014 survey findings: termination of Petitioner’s provider agreement on March 30, 2014, unless the facility abated immediate jeopardy before that date; a CMP in the amount of $5,800 per day, effective February 12, 2014, and continuing until immediate jeopardy was abated or Petitioner’s provider agreement was terminated; and a DPNA beginning March 19, 2014, and continuing until Petitioner returned to substantial compliance or its provider agreement was terminated. CMS Ex. 4; Joint Stipulations of Undisputed Facts (Jt. Stip.) ¶¶ 5-7.
CMS notified Petitioner on April 21, 2014, that it was modifying the remedies it had originally imposed based on the results of a March 26, 2014 revisit survey. CMS informed Petitioner that the revisit survey determined that Petitioner had abated immediate jeopardy, but Petitioner remained out of substantial compliance with program participation requirements. The April 21, 2014 notice informed Petitioner that: the $5,800 CMP was in effect from February 12 through March 9, 2014; a CMP in the amount of $200 per day began effective March 10, 2014, and would continue until Petitioner returned to substantial compliance or further revision by CMS; the DPNA effective March 19, 2014, remained in effect; and Petitioner’s provider agreement was subject to mandatory termination on September 7, 2014, if Petitioner did not return to substantial compliance before that date. CMS Ex. 5; Jt. Stip. ¶¶ 8-9.
On May 20, 2014, CMS notified Petitioner that a revisit survey on May 7, 2014, determined that Petitioner returned to substantial compliance as of March 29, 2014. CMS advised Petitioner that the DPNA ran from March 19 through March 28, 2014. The termination action was rescinded. CMS Exs. 6, 7, 66; Jt. Stip. ¶ 11.
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On May 6, 2014, Petitioner requested a hearing before an administrative law judge (ALJ) (RFH). Petitioner requested review of the CMS determinations announced in its notices dated March 17 and April 21, 2014. Petitioner requested review of only the deficiencies that CMS cited from the March 7, 2014 survey that alleged substandard quality of care and immediate jeopardy, specifically Tags F282, F441, F490, and F520. Petitioner challenged the $5,800 per day CMP that CMS imposed based on those deficiencies. Petitioner specifically did not request review as to the alleged deficiencies that were not alleged to pose immediate jeopardy or the $200 per day CMP that CMS imposed based on the non-jeopardy level deficiencies. RFH at 2; Jt. Stip. ¶ 10; Transcript (Tr.) 36-40. Petitioner also noted its objections to the Departmental Appeals Board (Board) practice, as reflected in decisions of the Board, of allocating the burden of proving substantial compliance to Petitioner in violation of 5 U.S.C. §556(d); allocating the burden of persuasion to Petitioner, thereby allowing the Board to minimize or disregard Petitioner’s evidence of compliance and depriving Petitioner of its property without due process; and allowing CMS to impose enforcement remedies without requiring CMS to show that it considered the regulatory criteria for imposing remedies required by 42 C.F.R. §§ 488.404 and 488.438(f). RFH at 5.
This case was assigned to me for hearing and decision on May 16, 2014, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at my direction. On October 30, 2014, I notified the parties that the case was scheduled for hearing from February 3 to February 6, 2015, by video teleconference. A hearing was convened by video teleconference on February 3, 4, and 5, 2015, and a transcript of the proceedings was prepared. CMS offered CMS Exs. 1 through 66, all of which were admitted as evidence except CMS Ex. 22 which was a duplicate of CMS Ex. 13 at 3.
Petitioner’s Exhibit 18 is a copy of the decision In re: Signature Healthcare of East Louisville, Case No. DAH DHC 14-1753 (Nov. 2014) issued by a hearing officer with the Kentucky Cabinet for Health and Family Services, Division of Administrative Hearing, Health Services Administrative Hearing Branch. The document was marked at my direction but not offered as evidence by Petitioner. The transcript of the related hearing
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was admitted in evidence marked as P. Exs. 16 and 17, and the depositions of the two surveyors (who also testified in this proceeding) were admitted as P. Exs. 14 and 15.
CMS called the following witnesses: Surveyor Patricia Hinson, R.N. (Registered Nurse) and Surveyor Betty Jo Branham, R.N. Petitioner called the following witnesses: Sarah Tomes, R.N., Petitioner’s Director of Nursing (DON); Carrie Busha, R.N., Petitioner’s Assistant Director of Nursing (ADON); Margaret Downs, a respiratory therapist at Petitioner’s facility; and Amber Gensheimer, R.N., Petitioner’s staff development coordinator and infection control nurse.
CMS filed its post-hearing brief and related documents on May 4, 2015. Petitioner filed its post-hearing brief (P. Br.) on April 27, 2015, and related documents on May 5, 2015. CMS filed its reply brief on June 2, 2015. Petitioner filed its reply (P. Reply) on May 29, 2015.
II. Discussion
A. Issues
Whether there is a basis for the imposition of an enforcement remedy; and, if so,
Whether the remedy imposed is reasonable.
B. Applicable Law
The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483. Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.
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being found not to be in substantial compliance – commonly referred to as the mandatory or statutory DPNA. Act § 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance. Act § 1866(b)(2). The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction. Act § 1819(h)(2)(B).
The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. “Substantial compliance [complying substantially] means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301 (emphasis in original). A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. Therefore, a facility may violate a statutory or regulatory requirement, but it is not subject to enforcement remedies if the violation does not pose a risk for more than minimal harm. The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm. 42 C.F.R. § 488.301. State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-.335. The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406.
Petitioner was notified in this case that it was ineligible to conduct a NATCEP for two years.
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only use nurse aides who have completed a training and competency evaluation program. Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs. Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set. The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D. Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a skilled nursing or nursing facility that has been: (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $5,000; or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management. Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements. “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. § 483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or § 483.25 (Quality of Care) that are found to constitute either immediate jeopardy; a pattern of or widespread actual harm that does not amount to immediate jeopardy; or a widespread potential for more than minimal harm that does not amount to immediate jeopardy with no actual harm. 42 C.F.R. § 488.301. In this case, the alleged substandard quality of care triggered an extended or partial extended survey and the ineligibility to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14)(ii) & (16) (finding of substandard quality of care that results in loss of approval of NATCEP is initial determination subject to review).
The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13). However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of
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noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, 363 F.3d 583 (6th Cir. 2003). The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).
The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.” Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted). The Board has long held that the petitioner bears the burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements and any affirmative defense. 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); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999). However, only when CMS makes a prima facie showing of noncompliance is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense. Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). The standard of proof, or quantum of evidence required, is a preponderance of the evidence. CMS has the burden of coming forward with the evidence and making a prima facie showing of a basis for imposing an enforcement remedy. The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.” Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004).
In Evergreene, the Board explained its “well-established framework for allocating the burden of proof on the issue of whether the SNF is out of substantial compliance” as follows:
CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement. If CMS makes this prima facie showing, then
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the SNF must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole that it was in substantial compliance during the relevant period.
DAB No. 2069 at 7. Petitioner disputes that the Board has correctly determined the allocation of the burden of persuasion. RFH at 5. Petitioner’s argument is discussed under Conclusion of Law 20.
C. Findings of Fact, Conclusions of Law, and Analysis
My conclusions of law are set forth in bold text followed by my findings of fact and analysis. I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision. I discuss in this decision the credible evidence given the greatest weight in my decision-making.
1. Petitioner did not request review of the following deficiency citations from the survey that ended on March 7, 2014 (CMS Ex. 1); the deficiency citations are administratively final; and the deficiencies are a basis for the imposition of enforcement remedies: 42 C.F.R. §§ 483.10(k), (l) (Tag F174) (s/s D); 483.15(a) (Tag F241) (s/s D); 483.15(h)(2) (Tag F253) (s/s E); 483.25(c) (Tag F314) (s/s D); 483.35(i) (Tag F371) (s/s F); 483.35(i)(3) (Tag F372) (s/s F); 483.60(b), (d), (e) (Tag F431) (s/s D); 483.70(g) (Tag F464) (s/s E); 483.75(j)(1) (Tag F502) (s/s D); and 483.75(l)(1) (Tag F514) (s/s D) (unchallenged deficiencies).
2. Petitioner did not request review of the following deficiency citations from the survey that ended on March 26, 2014 (CMS Ex. 3); the deficiency citations are administratively final; and the deficiencies
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are a basis for the imposition of enforcement remedies: 42 C.F.R. §§ 483.10(k), (l) (Tag F174) (s/s D); 483.15(a) (Tag F241) (s/s D); 483.15(h)(2) (Tag F253) (s/s E); 483.20(k)(3)(ii) (Tag F282) (s/s D); 483.25(c) (Tag F314) (s/s D); 483.35(i) (Tag F371) (s/s F); 483.35(i)(3) (Tag F372) (s/s F); 483.60(b), (d), (e) (Tag F431) (s/s D); 483.65 (Tag F441) (s/s E); 483.70(g) (Tag F464) (s/s E); 483.75 (Tag F490) (s/s E); 483.75(j)(1) (Tag F502) (s/s D); 483.75(l)(1) (Tag F514) (s/s D); and 483.75(o) (Tag F520) (s/s E) (unchallenged deficiencies).
3. The revisit survey completed on March 26, 2014, determined that immediate jeopardy previously declared to have begun on February 12, 2014, was abated as of March 10, 2014. Therefore, the period of immediate jeopardy at issue is February 12 through March 9, 2014.
4. Petitioner did not request review as to the reasonableness of a $200 per day CMP based on the unchallenged deficiencies for the period February 12 through March 28, 2014; therefore, the issue of the reasonableness of that remedy is administratively final.
5. The unchallenged deficiencies are a basis for the imposition of the enforcement remedy of a DPNA for the period March 19 through March 28, 2014, and Petitioner has not challenged the reasonableness of this enforcement remedy.
6. CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282).
7. The violation of 42 C.F.R. § 483.20(k)(3)(ii) posed a risk for more than minimal harm and amounted to noncompliance.
8. Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.
Based upon Petitioner’s request for hearing, the deficiencies at issue before me are those cited by the survey completed on March 7, 2014, as violations of 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282), 483.65 (Tag F441), 483.75 (Tag F490), and 483.75(o) (Tag F520) and alleged to have posed immediate jeopardy to Petitioner’s residents. The period at issue based upon the request for hearing is limited to the period during which the alleged deficiencies posed immediate jeopardy, February 12 through March 9, 2014.
After complete review of the entire record, I conclude that it is only necessary to discuss the example of Resident 17 to determine that the alleged violation of 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282) was correctly cited and that there was immediate jeopardy
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from February 12 through March 9, 2014. Resident 17 is cited as an example for each of the other alleged deficiencies under Tags F441, F490, and F520 that are also alleged to have posed immediate jeopardy. I also conclude that the example of Resident 17 establishes noncompliance under Tags F441, F490, and F520, and it is unnecessary to discuss the other examples cited under those deficiency citations.
The surveyors allege that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) and that the violation posed an isolated instance of immediate jeopardy. The surveyors allege that Petitioner violated the regulation because Petitioner “failed to have an effective system to ensure care was provided in accordance with the written plans of care” for Resident 17. CMS Ex. 1 at 21. The surveyors alleged that Resident 17’s care plan required droplet isolation precautions due to his diagnosis of Methicillin-Resistant Staphylococcus Aureus (MRSA) identified in his sputum. Surveyors allege they observed staff and family not complying with required infection control precautions when entering Resident 17’s room, including not donning personal protective equipment (PPE) or using hand sanitizer or washing hands when entering or exiting his room. The SOD alleges that Resident 17’s wife told a surveyor that she had not received instruction on using PPE and did not understand why she needed to wear a gown, gloves, and mask in the resident’s room. CMS Ex. 1 at 21-22.
Under Tag F282, the surveyors specifically alleged that the failure to “ensure staff followed care plan interventions to assure isolation precautions was likely to cause serious injury, harm, impairment, or death to residents in the facility,” which is immediate jeopardy. CMS Ex. 1 at 22. The surveyors alleged that immediate jeopardy
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began on February 12, 2014, when isolation precautions were added to Resident 17’s care plan, and was continuing when the survey ended on March 7, 2014.
a. Facts Applicable to All Deficiency Citations In Issue
(i.) Resident 17
Resident 17 was admitted to Petitioner on January 23, 2014, following discharge from the hospital where he was treated for aspiration pneumonia, which required a tracheostomy. He was 83 years old when admitted to Petitioner’s facility. CMS Ex. 20 at 7-10, 56; P. Ex. 1. He was assessed upon admission as having unclear speech and difficulty being understood and he had difficulty understanding others; he responded only to simple direct communications; and his vision was highly impaired. CMS Ex. 20 at 12. One report indicates he was unable to speak, and he could only nod yes or no in response to questions. CMS Ex. 20 at 56. Resident 17 was totally dependent upon staff for his activities of daily living. CMS Ex. 20 at 21-22. He was always incontinent of bowel and bladder. CMS Ex. 20 at 23. He suffered from anemia related to kidney disease, tachycardia, heart failure, hypertension, gastroesophageal reflux disease, chronic kidney disease with renal insufficiency, aspiration pneumonia, aphasia, acute and chronic respiratory failure; he had a tracheostomy; and he had a gastrostomy. CMS Ex. 20 at 24-25. Resident 17 was very ill, very limited in his ability to communicate, and very dependent upon others to stay alive.
Resident 17 was admitted to the hospital on February 4, 2014, due to respiratory failure. He was diagnosed with MRSA pneumonia and discharged back to Petitioner on February 12, 2014. CMS Ex. 20 at 159, 161; P. Ex. 2 at 5; P. Ex. 3 at 9-11; P. Ex. 7 at 1; Tr. 119-20. On February 13, 2014, droplet isolation was ordered due to MRSA in Resident 17’s sputum. P. Ex. 4 at 2; Tr. 120. Petitioner completed a Droplet Isolation Care Plan for Resident 17 dated February 12, 2014, based on the diagnosis of MRSA in his sputum. According to his care plan, Resident 17 was to be maintained in isolation while his infection was active. Interventions listed on the care plan specific to droplet isolation and MRSA included: wear gloves with all care; follow droplet and standard precautions; maintain well-stocked isolation cart at the room entrance; post droplet precaution sign on resident’s door; explain need for isolation to resident, family, and responsible party; wear mask for all care; structure program activities as one-on-one; serve Resident’s meals in room; and the resident was to wear a mask if he left the room. CMS Ex. 20 at 81, 110-11. Petitioner also started an infection care plan for Resident 17 dated February 12, 2014, which did not specifically address isolation due to MRSA. CMS Ex. 20 at 109, 116; Tr. 120. Laboratory reports dated February 20, February 28, and March 3, 2014, show continuing MRSA pneumonia. CMS Ex. 20 at 76, 78, 163-66, 173; P. Ex. 7 at 10. Nurse notes placed in evidence by Petitioner do not show that nursing staff educated Resident 17’s wife or other visitors about required infection and isolation precautions visitors were expected to observe until March 8, 2014, the day after the survey ended. P. Ex. 6.
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Petitioner offered no notes of staff recording their observations of visitors in PPE. P. Ex. 6 at 16. A nurse note dated March 8, 2014 at 9:00 a.m., the day after the survey ended, shows that Resident 17’s wife stated that was the first she heard the information about isolation and precautions. The nurse note indicates that when the nurse left the room, the resident’s wife was wearing gown, gloves, and mask and her purse and lunch bag were wrapped in a plastic bag. The nurse note states that a daughter of Resident 17’s wife was called and she described the correct use of PPE. But, the daughter stated that her mother was getting more forgetful. The nurse note states that the daughter committed to help monitor her mother, but there is no evidence showing how often the daughter actually visited Resident 17 with her mother, so the value of that commitment is impossible to judge. P. Ex. 6 at 17. A nurse note dated March 7, 2014, which is entered in the clinical record following the nurse notes from March 8, 2014, states that the wife was observed wearing gown, gloves, and mask at times and that the nurse instructed her to wear the PPE at all times when in the room. Why this note is out of sequence is not explained by the entry itself; for example, there is no notation that the note was a late entry. P. Ex. 6 at 18. A nurse note dated March 9, 2014, reflects another conversation with Resident 17’s wife about using PPE and her compliance. P. Ex. 6 at 19. The notes show that on March 14, 2014, the order for droplet isolation was changed to using only standard precautions and both Resident 17’s wife and her daughter were educated. P. Ex. 6 at 21.
A physician’s note by Mark Easterle, M.D. states that during a visit on March 8, 2014, again after the survey ended, he observed Resident 17’s wife to ensure her adherence to infection control, but he does not state whether she was compliant. Dr. Easterle stated that Resident 17 was not actively infected but rather colonized and that when the resident’s secretions were done he would discontinue isolation. P. Ex. 3 at 18-19; P. Ex. 4 at 4. I infer from Dr. Easterle’s notes that he believed isolation precautions were appropriate at least until Resident 17’s secretions decreased. On March 14, 2014, droplet isolation was discontinued and standard precautions were to be followed. P. Ex. 4 at 6.
(ii.) CDC Guidelines for Infection Control
The parties agree that the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (CDC Guidelines)(CMS Ex. 59) establish the standard of care for interventions to prevent the transmission of infections in healthcare settings.
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The SOM, which gives guidance to surveyors conducting surveys, states it is important that facility infection prevention and control practices reflect current CDC guidelines. SOM app. PP, Tag F441. Although the SOM does not specifically incorporate the CDC Guidelines by reference, the SOM clearly adopts the CDC Guidelines as the standard for infection control in long-term care facilities. Therefore, it is necessary to have a detailed understanding of the CDC Guidelines in effect at the time of the survey, which I conclude reflect the standard of care to be applied in a long-term care facility at that time.
The CDC Guidelines describe direct and indirect contact transmission. Direct transmission occurs when a microorganism is transferred from an infected person to another person without a contaminated intermediate object or person. Indirect contact transmission occurs when an infectious agent is transmitted through a contaminated intermediate object or person. Failure to use PPE such as gloves, masks, or gowns may result in direct transmission from an infected resident to a caregiver or a visitor. Indirect contact transmission may occur when a caregiver or visitor contacts a contaminated surface or item, clothing, uniforms, furniture, linen, or PPE for example. MRSA is specifically listed by the CDC as an example of a pathogen subject to indirect contact transmission. CMS Ex. 59 at 15-17, ¶ I.B.3.a. I infer that MRSA is also a pathogen that has a risk for direct transmission to a caregiver or visitor if they have direct contact with an infected resident without PPE.
The CDC describes MRSA as an epidemiologically important organism deserving of special attention in healthcare facilities due to its resistance to first-line therapies and
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increased morbidity and mortality. CMS Ex. 59 at 21-22, ¶ I.C.1. The CDC recognizes the unique challenges that are posed by long-term care facilities such as Petitioner. Long-term care facilities are typically populated by elderly individuals at increased risk for infection who stay in the facility for extended periods and have contact with each other in common eating and living areas and activities. Pathogens such as MRSA can lead to substantial morbidity and mortality, and prompt detection and control measures are required. CMS Ex. 59 at 34-35, ¶ I.D.2.a. The CDC Guidelines support a finding that MRSA poses a risk for serious harm or death to residents in a long-term care environment if not promptly detected and controlled with proper infection control measures.
The CDC notes that education of healthcare workers, patients,
The CDC explains that there are two tiers of infection control precautions: standard precautions which are applicable to all patients in all healthcare settings, regardless of the suspected or confirmed presence of a pathogen, and transmission-based precautions for patients known or suspected to be infected or colonized with infectious pathogens. Standard precautions apply to all patients regardless of suspected or confirmed infection in any healthcare setting and include hand hygiene and the use of gloves, gown, mask, eye protection, or face shield depending upon anticipated exposure to blood, body fluids, secretions, excretions except sweat, non-intact skin, and mucous membranes. Education and training on standard precautions are considered critical elements of standard precautions. Standard precautions protect healthcare workers and patients. CMS Ex. 59 at 66-67, ¶¶ III, III.A; CMS Ex. 59 at 129.
The CDC identifies three categories of transmission-based precautions: contact precautions, droplet precautions, and airborne precautions. Transmission-based precautions are used when standard precautions alone are inadequate to interrupt infection transmission routes. Transmission-based precautions are always used with standard precautions. CMS Ex. 59 at 69-70, ¶ III.B. Contact precautions are intended to prevent transmission of pathogens that may be spread by direct or indirect contact with the patient or the patient’s environment. CMS Ex. 59 at 70, ¶ III.B.1. The CDC recommends standard and contact precautions for MRSA. CMS Ex. 59 at 106.
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Healthcare workers caring for patients on contact precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient room. Donning PPE upon entering the room and discarding the PPE before departing the patient room is recommended to contain pathogens. CMS Ex. 59 at 70, ¶ III.B.1.
The CDC describes PPE as including the following components: gloves, isolation gowns, and face protection, including masks, goggles, and/or face shields. CMS Ex. 59 at 49-55, ¶ II.E. The various components of PPE may be used alone or in combination to protect mucous membranes, airways, skin, and clothing from pathogens. The selection of PPE is based on the nature of interaction with the patient and likely mode of transmission of a pathogen. The CDC states that containers for used disposable PPE should be located near where the PPE will be removed to facilitate disposal and containment of contaminated PPE.
The CDC states that hand hygiene is often cited as the single most important practice for reducing the spread of pathogens in the healthcare environment. Absent visible soiling of the hands, the CDC recommends alcohol-based products that do not require water over soap and water. CMS Ex. 59 at 49, ¶ II.D. The CDC specifies that hand hygiene is always the final step after removing PPE. CMS Ex. 59 at 49-50, ¶ II.E.
The CDC states that gloves are used to prevent contamination of healthcare personnel hands when touching a patient, bodily fluids, or equipment that may be contaminated by a pathogen. Gloves can also protect a patient from contamination on the hands of a healthcare worker or a visitor. When gloves are worn with other PPE, they are put on last. The CDC does not specifically state that gloves are also removed last when removing other PPE. The CDC does specify that hand hygiene always follows glove removal. CMS Ex. 59 at 49-51, ¶ II.E.1.
According to the CDC, gowns are used to protect healthcare workers’ arms and exposed body areas and to prevent contamination of clothing with potentially infectious materials. Use of an isolation gown by staff is required by the Occupational Safety and Health Administration Bloodborne Pathogens Standard. Standard Precautions require the use of a gown only when contact with blood or body fluid is anticipated. Contact precautions are used to prevent transmission of pathogens for which standard precautions alone are not adequate and that are associated with environmental contamination. When contact precautions are used, donning of an isolation gown and gloves is required upon entering the room in which contact precautions are in effect, specifically to address unintentional contact with contaminated environmental surfaces. CMS Ex. 59 at 51, ¶ II.E.2.
Masks are used to protect mouth and nose from contact with infectious material emitted by patients, such as respiratory secretions or sprays of blood or body fluids. Masks may be required under standard or transmission-based precautions. Masks are used during
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procedures that require sterile technique to protect the patient from pathogens that may be present in a healthcare worker’s nose or mouth. Masks are used on a coughing patient to limit the spray of respiratory secretions. Goggles may be used with a mask to protect the eyes as well as the nose and mouth, or a full-face shield may be used. Endotracheal suctioning, which Resident 17 required, is listed by the CDC as a procedure that may produce spray and requires use of a mask and goggles or a face shield. CMS Ex. 59 at 52-53, ¶ II.E.3. The CDC states that, even if droplet precautions are not recommended for a specific respiratory tract pathogen, eye protection using a mask and goggles or face shield is necessary if there is likely to be a splash or spray of respiratory secretions or other body fluid. The CDC also states that removal of a face shield, or goggles and mask, can be safely performed after gloves are removed and hand hygiene is performed because the ties, ear pieces, and headband are considered to be clean, while the front of the mask, goggles, or face shield are considered contaminated. CMS Ex. 59 at 53, ¶ II.E.3.b.
The CDC states that the use of gowns, gloves, and masks by visitors has not been addressed in the scientific literature, and there has been no determination of the effectiveness of requiring visitors to use a gown and gloves. But, the CDC says that there is a possibility of transmission of pathogens when a visitor has close patient contact, and a determination must be made by the facility regarding the use of PPE based on the level of interaction between a visitor and a patient. CMS Ex. 59 at 65, ¶ II.N.3.b.
In its discussion of the rationale for standard and transmission-based precautions, the CDC describes droplet transmission as a form of contact transmission because some infectious agents that can be transmitted in droplets can also be transmitted by direct and indirect contact. Respiratory droplets may be generated by a cough, a sneeze, talking, or suctioning and may occur during intubation, chest physiotherapy, and cardiopulmonary resuscitation. The CDC explains that droplet transmission occurs when respiratory droplets from an infected individual contact the mucosal surface of another, such as the conjunctiva (the membrane covering the eye and lining the lids), the interior of the nose, or the mouth and throat of a receptor individual. The CDC states that facial protection is the necessary protection for droplet transmission. The CDC is clear that the maximum distance for droplet transmission is not resolved. The CDC refers to studies indicating a risk of droplet transmission within three feet or less of the patient for selected infectious agents. However, the CDC also states that studies with smallpox and SARS indicate that these infections could be transmitted six or more feet by droplets. The CDC states that many factors could affect the distance for droplet transmission; thus, the distance of three feet or less is an example of what is meant by a short distance from a patient and is not the sole criteria for deciding when to don a mask. The CDC states that it may be prudent to don a mask when within six to ten feet or upon entry of a patient room, particularly when a highly virulent pathogen may be present. CMS Ex. 59 at 17, ¶ I.B.3.b. The CDC discussion clearly shows that droplet transmission requires more study and much remains unknown at this time. Droplet precautions are intended to prevent transmission of pathogens that may be spread through close respiratory or mucous membrane (eyes,
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mouth, nose) contact with respiratory secretions. The CDC does not specifically recommend droplet precautions for MRSA. However, facilities appear to have significant discretion under the CDC Guidelines to establish the most effective combination of standard and transmission-based precautions. In this case, Petitioner chose to add droplet precautions in the case of Resident 17. The CDC specifies that a mask is worn for close contact with an infectious patient on droplet precautions and is generally donned upon entry of the room. CMS Ex. 59 at 71, ¶ III.B.3. In Part IV of its 2007 Guidelines, the CDC recommends droplet precautions for patients known or suspected to be infected with pathogens that can be transmitted by respiratory droplets that are generated by a patient coughing, sneezing, or talking. The CDC recommended donning a mask upon entering a patient room, specifically did not recommend routinely wearing eye protection, and does not mention the use of a gown as part of droplet precautions. CMS Ex. 59 at 86-87, ¶ V.C.
The CDC included many recommendations in Part IV of its 2007 Guidelines, some of which I summarize as follows:
One recommendation is to provide instruction to patients and visitors on recommended hand hygiene, respiratory/cough etiquette, and the use of transmission-based precautions. CMS Ex. 59 at 77, ¶ II.B.
The CDC recommends treating everyone as potentially carrying a pathogen and to use standard precautions for all, including good hand hygiene; use of PPE when contact with blood or body fluids may occur, with removal and disposal of PPE before leaving the patient’s room; use of gloves when it can be reasonably anticipated that there will be contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, or potentially contaminated intact skin; use of a gown to protect skin and to prevent soiling or contamination of clothing when contact with blood, body fluids, secretions, or excretions is anticipated and removing the gown before leaving the patient environment; and use of masks, goggles, and face shields to protect the mucous membranes of the eyes, nose, and mouth during procedures likely to produce splashes or sprays of blood, body fluids, secretions, and excretions. CMS Ex. 59 at 77-80, ¶ IV.
The CDC recommends the use of transmission-based precautions in addition to standard precautions for patients with confirmed or suspected highly transmissible or epidemiologically important pathogens for which the transmission-based precautions are necessary. The CDC recommends that contact precautions be used for patients with confirmed or suspected infections that pose an increased risk for contact transmission, such as MRSA, including donning gloves upon entry into the patient room, wearing a gown whenever clothing may directly contact the patient or a potentially contaminated surface, donning the gown upon entering the patient
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room, and removing the gown and performing hand hygiene before leaving the patient-care environment. CMS Ex. 59 at 84-86, ¶ V.B.
Contact precautions are the standard for preventing the spread of MRSA in hospitals. P. Ex. 11 at 1. In this case, Petitioner’s care plan for Resident 17 required droplet precautions and did not specifically refer to contact precautions using that term. But the requirement to use a mask, gown, and gloves whenever in Resident 17’s room is really a combination of droplet and contact precautions. According to the CDC and published materials, Resident 17’s interdisciplinary team (IDT) should have care planned and implemented droplet precautions, based on the physician order and his apparent belief that MRSA could be spread by droplets, and contact precautions based on the CDC Guidelines for Resident 17. In fact, considering Resident 17’s care plan, Petitioner appears to have used elements of both contact and droplet precautions in addition to standard precautions. Petitioner’s failure to ensure both contact and droplet precautions were specifically named as such in the care plan created by the IDT was not cited as a basis for noncompliance and is not considered as such.
(iii.) State of Kentucky Infection Control Requirements
Petitioner offered as evidence an extract of the section on infection control from the Kentucky Public Health Practice Reference (Kentucky PHPR). P. Ex. 12. It is not clear from the document that the Kentucky Public Health Practice Reference is legally binding upon Petitioner or the surveyors, but I accepted the document as evidence of the standard of care in Kentucky. The Kentucky standard of care related to infection control appears to be based on the 2007 CDC Guidelines in most respects and the similarities are not listed here. However, there are some differences between the CDC Guidelines and the Kentucky PHPR. The Kentucky PHPR specifically requires as part of standard precautions that hands be washed before and after an examination, before gloving, and before leaving the examination room. P. Ex. 12 at 1, ¶ 1.d. The CDC Guidelines are not so specific, only specifying that hand-hygiene be performed after removing gloves. CMS Ex. 59 at 49-51, ¶ II.E.1; CMS Ex. 59 at 84-86, ¶ V.B. The Kentucky PHPR requirement for hand washing is literally limited to “examination.” However, it seems highly likely, when considered in context, that the drafters of the requirement intended the requirement to apply to other procedures as well. The Kentucky PHPR specifies that surgical masks and goggles or face shields and gown or aprons be worn during a procedure likely to generate splashes or sprays of blood or other body fluids. P. Ex. 12 at 2, ¶¶ 1.f, g. The requirements are consistent with CDC Guidelines, except the CDC is not so clear that use of a surgical mask as opposed to another type mask is required, and the CDC Guidelines do not address the use of an apron in lieu of a gown. CMS Ex. 59 at 77-80, ¶ IV. Under transmission-based precautions, the Kentucky PHPR specifies that precautions remain in place while test results are pending based on clinical presentation and likely pathogens, which may be understood to be inconsistent with the CDC Guidelines that suggest that precautions might be necessary permanently for a pathogen like MRSA, regardless of test
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results. P. Ex. 12 at 2, ¶ 2; CMS Ex. 59 at 72, ¶ III.D. The Kentucky PHPR requires that gown and gloves be worn for “all interactions” with a patient or contaminated areas to which contact precautions apply. P. Ex. 12 at 2, ¶ 2.a. The CDC Guidelines recommend gown and gloves when there is potential for contact with the patient or a contaminated surface. CMS Ex. 59 at 84-86, ¶ V.B. The Kentucky PHPR differs from the CDC Guidelines regarding the donning and removal of PPE when contact precautions are in effect. The Kentucky PHPR requires that “[a]ll protective equipment shall be applied prior to entry and discarded before exiting the environment containing a potentially infectious agent.” P. Ex. 12 at 2, ¶ 2.a. The CDC Guidelines for contact precautions recommend that PPE be donned upon entry to a room, which I infer means upon crossing the threshold into the room, and removal and disposal of PPE and hand hygiene before leaving a room subject to standard or transmission-based precautions. CMS Ex. 59 at 70, ¶ III.B.1.; CMS Ex. 59 at 70, ¶ III.B.1; CMS Ex. 59 at 77-80, ¶ IV.; CMS Ex. 59 at 84-86, ¶ V.B. The Kentucky PHPR requires that when contact precautions are in effect, a mask will be applied prior to entry and discarded after exiting the environment that may contain the potentially infectious pathogen. P. Ex. 12 at 3, ¶ 2.b.
(iv.) Petitioner’s Infection Control Policies
The CDC Guidelines, the Kentucky guidelines, and the SOM impose upon the long-term care facility and the individual resident interdisciplinary team the burden to determine which transmission-based infection control procedures are to be employed in addition to standard precautions based upon the needs of the affected resident and the resident population. Petitioner must determine the best combination of precautions to employ.
There is no dispute Petitioner had adopted infection control policies as required by regulation and consistent with the CDC Guidelines and the Kentucky guidelines. Contrary to arguments of Petitioner, I do not find the provisions of Petitioner’s infection control policies as being more restrictive, more specific, or more effective than the CDC and Kentucky guidelines. There is no dispute that Resident 17’s IDT adopted appropriate infection control interventions in Resident 17’s case, a combination of contact and droplet precautions in addition to standard precautions. The alleged noncompliance under Tags F282 and F441 is Petitioner’s failure to implement the care planned interventions in accordance with the care plan and Petitioner’s policy and the CDC and Kentucky guidelines. Therefore, it is necessary to review the requirements of Petitioner’s policy.
Petitioner’s policy for standard precautions requires the use of standard precautions for all residents regardless of their diagnosis or suspected or confirmed infection status. The assumption is that all body fluid, blood, secretions, and excretions (except sweat), non-intact skin, and mucous membranes may include pathogens. Staff training is required by the policy. Residents and family are required to be provided with information about standard precautions and the prevention of infections. The policy lists the following
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standard precautions: hand hygiene, gloves, masks and eye protection, and gowns. Hand hygiene is required whenever hands are visibly soiled, before eating, after using the restroom, and after removing gloves. Gloves are required when there is a potential for direct contact with blood, body fluids, mucous membranes, non-intact skin, or other potentially infected material; when having direct contact with one infected or colonized with MRSA or other MRDOs; when touching visibly soiled equipment or equipment that is potentially contaminated with pathogens; gloves are to be changed when necessary to avoid cross-contamination; gloves are to be removed promptly after use, before touching non-contaminated surfaces, and before going to another resident’s room; and hand hygiene is to be done immediately after removing the gloves. Masks and eye protection or face shields are to be used to protect mucous membranes of the eyes, nose, and mouth when procedures are performed that are likely to generate splashes or sprays of body fluids, blood, secretions, or excretions. Gowns are to be worn to protect skin and prevent soiling of clothing during procedures likely to generate splashes or sprays. Gowns are to be removed and hand hygiene performed before leaving a resident’s room. CMS Ex. 28.
Petitioner’s policy that addressed multi-drug resistant organisms (MDROs) such as MRSA, provides that “[s]taff will use standard precautions as the primary approach to preventing transmission of MDROs.” P. Ex. 8 at 8, ¶ 3. This policy seems to be at odds with the CDC Guidelines, but it was not cited as a deficiency, and I do not consider it as such. The MDRO policy is also inconsistent with Petitioner’s policy that specifically addresses MRSA and recognizes that the CDC recommends contact precautions for MRSA. CMS Ex. 25 at 1. This inconsistency was also not cited as a deficiency in Petitioner’s policy and is not considered as such. Petitioner’s MDRO policy required that hand hygiene was to be performed according to the hand hygiene policy. P. Ex. 8 at 8, ¶ 4. Masks are not recommended for routine use except when there was a risk for splashing body fluids. Each individual with known or suspected MDROs is to be evaluated by staff and practitioner to determine whether contact precautions are necessary. P. Ex. 8 at 8, ¶ 6. The policy provides that healthy visitors and volunteers are encouraged to wear disposable gowns and gloves during visitation and, if they refused, they are to be asked to perform hand hygiene before leaving the room and requested not to visit with other residents. If contact with body fluids is expected, disposable gloves are to be worn and hand hygiene performed after removing gloves. P. Ex. 8 at 10, ¶¶ 17, 20.
Petitioner’s hand hygiene policy specified that residents, family, and visitors were to be encouraged to practice hand hygiene through the distribution and posting of materials. Petitioner’s policy required hand hygiene before and after direct resident contact, before and after entering isolation precaution settings, after contact with body fluids or
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excretions, after removing gloves or aprons, and at other times specified. The policy provides that hand hygiene is always the final step after removing and disposing of PPE. The policy also provides that using gloves does not satisfy the requirement for hand hygiene. P. Ex. 8 at 15-16. The policy required the following hand-washing procedures: wash hands, dry hands with a paper towel, and use a clean, dry paper towel to turn off the faucet. P. Ex. 8 at 17. CMS placed in evidence a copy of Petitioner’s hand hygiene policy with an additional document that inconsistently instructs staff to dry their hands with a paper towel and to use that paper towel to turn off the water. CMS Ex. 38 at 5, 7.
Petitioner’s transmission-based precautions policy covers airborne precautions, contact precautions, and droplet precautions. The policy specifies that standard precautions are to be used at all times when caring for patients and transmission-based precautions are used when it was documented or suspected that a resident had a communicable disease or infection. Droplet precautions or droplet isolation, as referred to in the clinical record, was ordered for Resident 17 based on the presence of MRSA in his sputum. P. Ex. 4 at 2. According to Petitioner’s policy, droplet isolation was appropriate for a pathogen that can be transmitted by droplets that could be generated by coughing, sneezing, talking, or procedures such as suctioning, which Resident 17 required every two hours. I agree with Petitioner that there is evidence that there is little likelihood of transmitting MRSA via droplets, but droplet isolation was ordered by Resident 17’s physician and Resident 17’s IDT care planned for droplet precautions with the notable addition of gloves and gown, which are more consistent with contact precautions. Petitioner’s policy for droplet isolation required standard precautions and donning a mask when entering the isolation room, which is consistent with CDC recommendations. The policy required the posting of a sign to alert staff and visitors to the type or precautions required. P. Ex. 8 at 18-23; CMS Ex. 29. This policy does not mention using a face shield or goggles when doing a procedure that may create droplets, but the requirement is found in Petitioner’s PPE policy. CMS Ex. 31 at 2-5.
Petitioner’s policy regarding initiation of transmission-based precautions addresses contact precautions, droplet precautions, and airborne precautions and provides that they are initiated when there is reason to believe a resident has a communicable or infectious disease. When transmission-based precautions are in effect, the Petitioner’s Infection Preventionist (IP) is required to ensure that PPE is maintained near the resident’s room so anyone entering the room can access the necessary PPE. The IP is also to ensure a notice is posted on the room door and resident’s chart advising of the precautions in effect and/or that it is necessary to see a nurse before entering the room. The IP is to ensure that a linen barrel or hamper and waste container are in or near the resident room. Supplies and equipment needed while transmission-based precautions are in effect are to be placed in the isolation room. An adequate supply of antiseptic soap and paper towels is to be maintained in the room during the isolation period. The resident or his or her representative is to be educated about the reason for the precautions. CMS Ex. 30 at 1.
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The sign Petitioner uses when droplet or contact precautions are in effect is in evidence at CMS Ex. 33. Tr. 363-72, 444, 817-20. The sign indicates that for contact precautions, everyone must clean hands when entering and leaving the room, follow standard precautions, and wear gown and gloves when entering the room. The sign indicates that doctors and staff must use patient-dedicated or disposable equipment and clean or disinfect any shared equipment. CMS Ex. 33 at 2. The sign for droplet precautions indicates that everyone must clean hands when entering and leaving the room, follow standard precautions, wear a mask, and wear eye protection if splash or spray to the eyes is likely. The sign indicates that doctors and staff must wear gown, gloves, mask, and eye protection if contact with body fluids is likely. CMS Ex. 33 at 1.
Petitioner’s PPE policy requires employees performing tasks that involve exposure to blood or body fluids be provided with appropriate PPE. The policy provides that the PPE to be used depends on the task and potential exposure. PPE to be available includes gowns, aprons, lab coats, gloves, masks, and face shields or goggles. A supply of PPE is to be maintained at each nurse station, and failure to use PPE when indicated is grounds for employee discipline. P. Ex. 8 at 25; CMS Ex. 31 at 1. Petitioner had a specific PPE policy regarding the use of eye protection (CMS Ex. 31 at 2-3); face masks (CMS Ex. 31 at 4-5); gloves (CMS Ex. 31 at 7-10); and gowns, aprons, and lab coats (CMS Ex. 31 at 11-13). According to the policy related to eyewear, it is to be available in each treatment or examination room and is required to be used when anticipating splashes or sprays to the eyes. The policy specifies that masks must be worn with goggles and face shields. Hand hygiene is required after removing the mask and eyewear. CMS Ex. 31 at 2-3. The face mask policy specified that masks are to be used when there is a possibility of transmission by droplets or splashes or sprays. The policy requires the use of a mask any time a task is to be performed that may involve a splash or spray of blood or body fluids that might contact the mouth or nose. The policy requires that a mask be used when eye protection is used. The policy requires that a mask be donned before entering the room and after cleaning hands, suggesting that hands need to be cleaned somewhere outside the room. The mask must cover the nose and mouth. Hands must be washed before changing or removing the mask. The mask is to be handled only by the ties/strings. The policy specifies that, in addition to using the mask when there is a potential for splashes and sprays, a mask is to be used when the use of the mask is indicated and when providing treatment to a patient with a communicable respiratory infection. Procedures of donning the mask are specified: obtain mask, wash hands, remove mask from container and unfold, place mask over nose and mouth, tie mask, avoid unnecessary handling of mask, and do not touch the mask when in use. The procedures for removal require washing hands first, untying and removing from face touching the ties only, discarding the mask in a receptacle in the room, and then washing hands again. CMS Ex. 31 at 4-6. The PPE policy related to gloves requires they be used any time there is possible contact with blood, body fluids, secretions, excretions, mucous membranes, or non-intact skin. Gloves are to be used only once and must be discarded in the receptacle in the room in which used. Gloves are also to be used when an employee’s hands may be
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chapped, scraped, have a wound or rash, or other skin condition; when handling potentially contaminated linen; and anytime in doubt about possible contamination with pathogens. Hand hygiene must be done after removing gloves. The policy specifies that employees must be trained on the use of gloves. The policy provides that gloves are to be removed before removing mask and gown and all are to be discarded in the receptacle in the room. Hand hygiene is to be done before donning gloves and, if a gown is required, the gown should be donned before the gloves. Gloves are to be removed by pulling down on the cuff and turning the glove inside out. Gloves are to be discarded in the proper receptacle in the room. Hand hygiene is required after removing gloves. CMS Ex. 31 at 7-10.
Petitioner’s PPE policy related to gowns requires that a gown, apron, or lab coat be worn when there is the potential for soiling clothing with blood, body fluids, secretions, or excretions. Gowns may only be used once and must be discarded in the proper receptacle in the room. Gowns, aprons, and lab coats are maintained at the central supply, nurse stations, and isolation rooms. Employee training is required. The policy for donning a gown requires that it be put on before gloves and that it be properly secured to cover all clothing. The policy for removing the gown requires that it be removed and deposited in the proper receptacle in the room, followed by washing the hands, then removing the mask, if any, and again washing the hands. CMS Ex. 31 at 11-13.
Petitioner’s policy regarding visitation and infection control provides that the family of residents will be educated regarding Petitioner’s infection control practices related to visitation, including standard precautions, hand hygiene, respiratory hygiene, vaccinations, and signs and symptoms of communicable diseases. The policy provides that visitation during transmission-based precautions is permitted, but family members providing care or having very close contact with the resident will be trained regarding infection control barriers such as PPE. Signs posted in the facility encourage visitors to use proper hand hygiene upon arrival and departure and cough etiquette/respiratory hygiene. CMS Ex. 34. According to Petitioner’s counsel, Petitioner’s policy was that anybody, including staff and visitors, entering a room with isolation precautions in effect should wear proper PPE, including mask, gown, and gloves. Petitioner conceded at hearing that if Resident 17’s wife was not wearing her PPE that would violate Petitioner’s policy. Tr. 615-17.
(v.) Scientific Uncertainty Regarding Efficacy of Isolation
Petitioner introduced as evidence without objection an article published August 21, 2014, in The Lancet, a peer-reviewed general medical journal. The article, titled “Screening and isolation to control methicillin-resistant Staphylococcus aureus: sense, nonsense, and evidence,” acknowledges the importance of hand hygiene in preventing the spread of MRSA but suggests that the efficacy of isolation and its negative effects upon patients requires more study. The article recognizes that contact isolation remains the established
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standard for preventing the spread of MRSA. P. Ex. 11. Petitioner’s purpose for offering this evidence and citing it in its briefs seems to be to negate or minimize the impact of the CDC Guidelines that establishes contact isolation as the standard for preventing the spread of MRSA. P. Br. at 11 n.6; P. Reply at 18 n.7. I do not find that the article or questions raised about the efficacy of isolation in dealing with MRSA outweigh the CDC Guidelines’ recommendation that contact precautions be used in dealing with MRSA (CMS Ex. 59 at 84-86, ¶ V.B) given the conclusion of the article that more study is required.
(vi.) Statement of Deficiencies (SOD) and Witness Testimony
The SOD for the survey that ended on March 7, 2014, records the surveyor observations during the survey. During the initial tour of the facility on March 4, 2014 at about 8:36 a.m., the surveyors observed an isolation cart outside Resident 17’s room and a sign posted on the door indicating droplet precautions were in effect. CMS Ex. 1 at 24. At about 9:04 a.m. on March 4, a surveyor observed Resident 17 in bed and his wife enter the room wearing a long coat, carrying bags, and she did not don any PPE. CMS Ex. 1 at 48. On March 6, 2014 at 9:37 a.m., Resident 17’s wife was in his room wearing a disposable gown that covered her front but was not tied in the back and a mask that was not covering her nostrils. She was not wearing gloves and was observed touching the television. On March 6, 2014 at about 10:23 a.m., Resident 17 was in bed, his wife was sitting at the bed side wearing a disposable gown and a mask that covered her nostrils, but she was not wearing clean gloves. The SOD records an interview of Resident 17’s wife on March 6, 2014 at 10:25 a.m., during which she stated she had received no instruction from Petitioner’s nursing staff on using PPE, she did not understand why she had to wear PPE while in the room, and she had received no information about Resident 17’s infection or why isolation was required. CMS Ex. 1 at 24, 48-49. The SOD records observations from March 7, 2014 at about 9:01 a.m., at which time Resident 17’s wife entered his room wearing a long coat and carrying three bags. The resident’s wife failed to don PPE or perform hand hygiene. The SOD records that Resident 17’s wife placed an article of clothing on the resident’s over-bed table and then closed the resident’s door. CMS Ex. 1 at 26, 49.
Surveyor Patricia Hinson, R.N., was called as a witness, and she testified that she participated in the surveys completed on March 7 and March 26, 2014. Tr. 136. Surveyor Hinson testified that the survey began on March 4, 2014, and the team began to recognize breaks in infection control on all three units of Petitioner’s facility. She testified that Petitioner did have policies for infection control but the surveyors’ observations showed that the policy was not implemented. Surveyor Hinson testified that the survey team observed breaks in infection control by at least seven staff related to hand-hygiene, management of isolation precautions, clean technique when administering eye medications, feeding by G-tube, hand wound care, and handling linens. She opined
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that Petitioner had a systemic problem with implementing its infection control policies as at least seven staff members and seven residents were involved and the breaks in infection control related to a variety of cares and services. Tr. 161-66. She explained that many nursing home residents have compromised immune systems and the spread of infection can cause harm or death. Tr. 168-69. She testified that Petitioner was not cited for not having required infection control policies and that Petitioner’s policies were acceptable. Tr. 354-58, 396, 407. She testified on cross-examination that she did not witness Resident 17 cough, but secretions had to be suctioned regularly, and she did not observe him being suctioned. She testified that she observed Resident 17 on March 4, 6, and 7, 2014; she interviewed Resident 17’s wife; she observed him in his bed and in his wheelchair next to his bed; and she did not observe care being delivered except by the respiratory therapist. She subsequently testified that she did not actually see the resident on March 4, 2014, and only did a record review and interviewed ADON Busha that day. Tr. 401-02. She testified that she first saw Resident 17 on March 6, 2014, when the respiratory therapist was finishing her care of the resident. Tr. 419. She testified that she did not see visitors other than the resident’s wife in Resident 17’s private room. The resident’s wife was observed with PPE properly donned on some occasions but not on others. The surveyor observed a green sign on the resident’s door advising of droplet precautions in effect, and she identified CMS Ex. 33 at 1 as being similar to the sign she observed. Tr. 363-72, 444.
On cross-examination, Surveyor Hinson testified that in citing deficiencies related to Resident 17, she did not consider any guidance regarding a three-foot radius around the resident. She considered that Petitioner designated Resident 17’s entire room as requiring droplet precautions. Tr. 377-80. Surveyor Hinson testified that on March 7, 2014, she and another surveyor observed Resident 17’s wife enter his room in a long coat, with bags and a blanket. She entered the room without donning PPE and laid the blanket on the resident’s over-bed table that was by his bed. Resident 17’s wife then closed the room door. Surveyor Hinson testified that later she saw the wife properly attired in PPE. Tr. 425-27. She agreed that while the DON stated in an interview with Surveyor Hinson that she had received reports of noncompliance by the resident’s wife, she did not say when she received such reports. Tr. 429. Surveyor Hinson explained in response to my questions that standard precautions apply to every resident, and contact precautions are a higher-level of precaution used for special cases when necessary. Tr. 447. She testified on redirect that in her opinion, PPE must be donned before entering a room in which droplet precautions are in effect irrespective of any CDC three-foot radius rule. Tr. 458-59. Surveyor Hinson testified that she found no evidence that Resident 17’s wife was involved in his care plan meetings. She testified that is one reason Petitioner was cited and a basis for immediate jeopardy. Tr. 460. She testified that PPE is to be removed before leaving the room for which droplet precautions are in effect. Surveyor Hinson testified that, notwithstanding any CDC guidance regarding a three-foot zone around a resident, other areas of a room can be contaminated by those moving around in the room and, therefore, the entire room should be treated as an
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isolation area. Surveyor Hinson testified that the deficiency was cited related to the actions of Resident 17’s wife based on surveyor observations that she did not don PPE when entering Resident 17’s room; she was not properly attired in PPE when in the room because the gown was not tied; the mask did not cover her nostrils; and she was not wearing gloves. She opined that the goal of the droplet precautions was to prevent the spread of MRSA, not to protect Resident 17 from additional infections. Tr. 239-43. She testified that in her opinion, other residents were at risk for contracting MRSA because Resident 17’s wife failed to properly use PPE and to wash her hands before leaving Resident 17’s room and by the spread of infection on her hands or articles she carried in and out of the room. Tr. 248-49.
Surveyor Hinson testified that Certified Nurse Assistant (CNA) Al-Sharawi told her that Resident 17’s wife did not wear booties or gloves in Resident 17’s room. Tr. 252. She testified that she requested documentation reflecting that Resident 17’s wife was trained in the use of PPE but no documentation was provided to her. Tr. 253-54. Surveyor Hinson testified that she interviewed R.N. Amber Gensheimer, Petitioner’s staff development coordinator and infection control nurse. Surveyor Hinson testified that R.N. Gensheimer told her that nursing staff on the unit was responsible for educating employees and visitors about the use of PPE and enforcing the standard. The education procedure applied to Resident 17’s wife as well. R.N. Gensheimer was reported by Surveyor Hinson to have stated that Resident 17’s wife was educated or reminded on a daily basis regarding infection control and use of PPE and documentation of this effort should be in nurse notes. However, Surveyor Hinson testified that Petitioner never produced documentation supporting R.N. Gensheimer’s statements. Surveyor Hinson opined that Petitioner’s system was not effective as she saw Resident 17’s wife three times without PPE or without PPE properly donned. She testified that the declaration of immediate jeopardy was based, in part, upon the ineffectiveness of Petitioner’s procedures. She opined that Petitioner should have been more consistent and direct in helping Resident 17’s wife with her PPE. She did not see a sign on Resident 17’s door directing visitors to see a nurse before entering the room. Tr. 268-73. Surveyor Hinson testified regarding alleged noncompliance under Tag F282 that the care plan for Resident 17 in evidence as CMS Ex. 42 required that staff educate Resident 17’s wife. Resident 17’s wife told Surveyor Hinson that she did not understand why PPE was necessary. Surveyor Hinson testified that during the survey, she found no documentation that the wife was educated. She testified that the absence of evidence that the wife was educated was a fact that contributed to the determination to declare immediate jeopardy. Tr. 275-78, 283-84.
I find that Surveyor Hinson’s testimony regarding her observations and why she believed noncompliance existed is credible. However, I rely upon the CDC Guidelines and the Kentucky PHPR as the credible sources for infection control procedures.
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Surveyor Betty Jo Branham, R.N. was called and testified. Tr. 481-82; CMS Ex. 49. She explained that when a person with a tracheostomy (trach), such as Resident 17, coughs, the phlegm or mucous will generally exit the trach tube and land wherever unless the trach tube is covered. She testified that when suctioning of the trach tube occurs there can be a spray of droplets. Tr. 486-502. Surveyor Branham was the team leader for the survey that ended on March 7, 2014. Tr. 503. She testified that the failure of Resident 17’s wife to properly use PPE was an independent justification for the declaration of immediate jeopardy. Tr. 514-17. Regarding Tag F490 (CMS Ex. 1 at 62-65), Surveyor Branham testified the citation was based on the examples of Resident 17 and his wife’s failure to use PPE, violation of clean technique, and the safe handling of linens; and all were the basis for the citation of immediate jeopardy. Tr. 573-81.
I find credible the testimony of Surveyor Branham regarding her observations and why she believed that Petitioner was not in substantial compliance. However, I rely upon the CDC Guidelines and the Kentucky PHPR as the credible sources for infection control procedures.
Margaret Downs, Petitioner’s respiratory therapist, testified that she cared for Resident 17; he had a trach; and he could cough but it was a weak cough. Tr. 664, 673-74. She testified that Resident 17’s wife seemed to be cognitively intact. When the resident was admitted in January 2014, he was on standard precautions, and Ms. Downs had no reason to provide Resident 17’s wife any training on infection control. Tr. 675-76. After Resident 17 was placed on droplet precautions, she recalled discussing with the wife the need for the precautions, and the wife agreed to comply. However, she did not testify when she discussed infection precautions with Resident 17’s wife. Tr. 679. She testified that she was not aware of any problem with breaches of infection control protocols prior to the survey. She testified that she recalled one occasion of the wife not wearing gloves when she exited the bathroom; she asked why she was not wearing her gloves; and the wife explained she had just washed her hands and was preparing to put gloves on. Tr. 680-81. She testified that during the survey she was asked by Surveyor Hinson whether she was aware of Resident 17’s family member not using PPE; Nurse Busha told her that there was an issue of Resident 17’s family member not using PPE; and she reported this information to the Administrator and DON. Tr. 683-85. She testified that the surveyor observed her in Resident 17’s room and asked her questions about the equipment in use. Tr. 686-88. I find that Ms. Downs’s testimony is credible. However, she was not specific as to when she educated Resident 17’s wife about Resident 17’s infection and infection control procedures.
Sarah Tomes, R.N., Petitioner’s DON at the time of the survey, described generally the quality assurance process for infection control, the development of infection control policies, and training to those policies. Tr. 744-52. She described generally the implementation of droplet precautions. Tr. 753-54. She testified that for a resident on droplet precautions, staff is to don PPE before they care for the resident and remove the
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PPE and wash their hands before leaving the room. Tr. 757-58. She testified that Petitioner’s policy is more restrictive than the CDC Guidelines as they apply precautions to the entire resident room, not just the area three feet around the resident. Tr. 791. Her testimony is inaccurate. The CDC recommends standard and contact precautions for MRSA. CMS Ex. 59 at 106. Healthcare workers caring for patients on contact precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient room. Donning PPE upon entering the room and discarding the PPE before departing the patient room is recommended by the CDC to contain pathogens. CMS Ex. 59 at 70, ¶ III.B.1. Nurse Tomes testified that she never received a report about Resident 17’s wife not wearing PPE properly prior to the survey. Tr. 765. Nurse Tomes testified that on the Saturday following the survey, she told Resident 17’s wife she had to wear PPE correctly and staff was supervising her when she visited; the wife became angry about someone sitting in Resident 17’s room with her and she banged her hands on the table and said to DON Tomes that she did not understand why this was being done. On cross-examination, she testified that she was unaware of the wife having a similar reaction at the beginning of the isolation when she was purportedly trained by staff. She testified that she was not aware of any need to give the wife frequent reminders to use PPE. Tr. 768-70, 798-804, 806. In response to my questioning, she agreed that CMS Ex. 33, which would be placed at the door of a room in which droplet precautions are in effect, does not say that visitors must wear a gown and gloves. DON Tomes explained that Petitioner’s policy requires that a visitor to a room with droplet isolation precautions in effect should follow the same guidelines as staff. Tr. 817-20. Her testimony regarding visitor use of PPE is consistent with Petitioner’s policies in evidence. Her testimony is credible.
Carrie Busha, R.N., was an ADON for Petitioner assigned to the 300 Unit, Petitioner’s 34-bed rehabilitation unit, where Resident 17 was housed. When Resident 17 was first admitted, he was on standard precautions, but that was changed to droplet isolation when he returned from the hospital with MRSA. She observed Resident 17’s wife, who had a regular routine of arriving, going straight to Resident 17’s room and spending the day with her husband, and staying in the room. Resident 17’s wife did not interact with other residents. She testified that she never observed the wife noncompliant with PPE requirements. Staff did not report to her any noncompliance with PPE requirements by the wife. The respiratory therapist told her that the surveyors were concerned about the wife’s compliance with PPE. She testified that she told DON Tomes about the surveyor’s concern. Tr. 825-34. Nurse Busha’s testimony is credible.
Amber Gensheimer, R.N., Petitioner’s nurse educator and infection control nurse was called and testified. Tr. 840. Nurse Gensheimer testified that Petitioner’s infection control policies included in P. Ex. 8 are based on and consistent with CDC policies. Tr. 857. She testified that most residents who require isolation are moved to the private rooms on the 300 Unit. Tr. 861. Her office is on the end of the 300 Unit, and she walks the hall 15 times each day. Tr. 864-65. She was familiar with the case of Resident 17.
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She was aware that Resident 17’s wife visited regularly. She testified that the resident’s wife was educated regarding infection control by Marc Kennedy, a transitional care nurse, who reported to Nurse Gensheimer that he had done the education. However, there are no documents in evidence showing that Nurse Kennedy did the training, and he was not called to testify. She opined that Resident 17’s wife may have been forgetful and Nurse Kennedy, respiratory therapist Downs, and Nurse Busha reminded Resident 17’s wife to wear PPE multiple times. She opined that under the circumstances, monitoring and frequent reminders of the wife were appropriate interventions. However, there is no documentation prior to the survey of monitoring or reminders, and Nurse Gensheimer provided no detail as to when monitoring was implemented and reminders occurred. She testified that she never personally observed Resident 17’s wife being noncompliant with PPE requirements. She knew staff reminded the wife to wear PPE, but she never received any complaints prior to the survey that the wife was not wearing PPE correctly. The first complaint she heard about the resident’s wife not complying with PPE requirements was during the survey. Tr. 869-77. Nurse Gensheimer’s testimony is credible.
Danny Sweeney, one of Petitioner’s CNAs, was called and testified in the state administrative proceeding but not before me. Petitioner placed his testimony in evidence as part of P. Ex. 16, the transcript of the state proceeding. CNA Sweeney testified that he provided care for Resident 17 and that he was aware that Resident 17’s wife visited almost daily. He testified that at times, he saw the wife in Resident 17’s room with her gloves off or some other defect in her PPE. He testified that he would remind her to put her gloves on and reported the problem to his nurse supervisor. He testified that the incidents were not frequent but he clearly suggested such incidents occurred more than once. P. Ex. 16 at 211-14. This prior recorded testimony is credible.
(vii.) MRSA Poses A Serious Health Risk
The CDC describes MRSA as an epidemiologically important organism and deserving of special attention in healthcare facilities due to its resistance to first-line therapies and increased morbidity and mortality. CMS Ex. 59 at 21-22, ¶ I.C.1. The CDC recognizes the unique challenges that are posed by long-term care facilities such as Petitioner. Long-term care facilities are typically populated by elderly at increased risk for infection who stay in the facility for extended periods and have contact with each other in common eating and living areas and engage in activities together. Because pathogens such as MRSA can lead to substantial morbidity and mortality, prompt detection and control measures are required. CMS Ex. 59 at 35, ¶ I.D.2.a. There is no dispute that MRSA poses a risk for serious harm or death for residents of long-term care facilities. CMS Exs. 52-58.
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b. Analysis
The surveyors allege in the SOD for the survey that ended on March 7, 2014, that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) and that the violation posed immediate jeopardy. CMS Ex. 1 at 21. The regulation requires that services provided or arranged by a facility must “[b]e provided by qualified persons in accordance with each resident’s written plan of care.” 42 C.F.R. § 483.20(k)(3)(ii). A facility is required to develop a comprehensive plan of care for each resident using the resident’s IDT, which includes the resident’s attending physician, a registered nurse with responsibility for the resident, and other appropriate staff determined based on the needs of the resident. 42 C.F.R. § 483.20(k)(1). The surveyors allege that Petitioner violated the regulation in the example of Resident 17 because Petitioner failed to have an effective system to ensure care was provided in accordance with his plan of care. More specifically, the surveyors allege that Petitioner failed to ensure that Resident 17’s wife followed droplet precautions required by Resident 17’s care plan. I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) in the case of Resident 17 and that the violation posed a risk for more than minimal harm. I further conclude that Petitioner failed to rebut the prima facie showing.
There is no dispute that Resident 17 returned to Petitioner from the hospital on February 12, 2014. When he returned, Resident 17 had the diagnosis of MRSA pneumonia. CMS Ex. 20 at 159, 161; P. Ex. 2 at 5; P. Ex. 3 at 9-11; P. Ex. 7 at 1; Tr. 119-20. On February 13, 2014, droplet precautions were ordered due to MRSA in Resident 17’s sputum. P. Ex. 4 at 2; Tr. 120. Petitioner completed a Droplet Isolation Care Plan for Resident 17 dated February 12, 2014. According to his care plan, Resident 17 was to be maintained in isolation while his infection was active. Interventions listed on the care plan specific to droplet isolation and MRSA included: wear gloves with all care; follow droplet and standard precautions; maintain well-stocked isolation cart at the room entrance; post droplet precaution sign on resident’s door; explain need for isolation to resident, family, and responsible party; wear mask for all care; one-on-one activities; meals in room; and the resident was to wear a mask if he left the room. CMS Ex. 20 at 81, 110-11. Laboratory reports dated February 20, 2014, and March 3, 2014, show continuing MRSA pneumonia and the need for transmission-based precautions continued. CMS Ex. 20 at 76, 78, 163-66, 173; P. Ex. 7 at 10.
Pursuant to 42 C.F.R. § 483.65(a)(2), Petitioner is responsible for determining what procedures, including isolation, should be applied to an individual resident to help control and prevent infections within the facility. Although not specified by 42 C.F.R. § 483.65(a)(2), this responsibility should fall upon the IDT pursuant to 42 C.F.R. § 483.20(k)(1), subject to Petitioner’s policies related to infection control. The CDC Guidelines and the Kentucky guidelines recommend specific infection control procedures such as hand hygiene and standard precautions for all residents but grant facilities significant discretion to determine which procedures are most appropriate given the
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individual resident or patient, known or suspected pathogens, and the care or services to be delivered. The CDC Guidelines and Kentucky guidelines recommend standard precautions for all residents, and masks, gowns, goggles or face shields, and gloves may be used as part of standard precautions depending upon the care and services to be performed for or provided to an individual resident. CMS Ex. 59 at 77-80, ¶ IV. Transmission-based precautions, including contact precautions, droplet precautions, and airborne precautions, are recommended in addition to standard precautions for residents with confirmed or suspected highly transmissible pathogens depending upon the routes of transmission that are possible. The CDC specifically recommends contact precautions for MRSA, which the CDC notes can be spread by either direct or indirect contact with an infected individual. CMS Ex. 59 at 15-17, ¶ I.B.3.a; 106. According to the CDC Guidelines, healthcare workers caring for patients on contact precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient room. Donning PPE upon entering the room and discarding the PPE before departing the patient room are recommended to contain pathogens. CMS Ex. 59 at 70, ¶ III.B.1. Petitioner’s transmission-based precautions policy also indicates that contact precautions are required for MDROs such as MRSA, but on a case-by-case basis. CMS Ex. 29 at 3. In the case of Resident 17, Petitioner characterized the transmission-based precautions adopted as droplet precautions or droplet isolation because Resident 17’s sputum carried MRSA. P. Ex. 4 at 2. However, the specific PPE selected for use by the IDT, which included gown and gloves in addition to a mask, are very much like contact precautions as described by the CDC for use with MRSA and as required, on a case-by-case basis, by Petitioner’s policy. CMS Ex. 29 at 3. The fact that the IDT clearly applied the precautions to Resident 17’s room is also consistent with contact precautions as recommended by the CDC. Petitioner’s characterization of the transmission-based precautions adopted for Resident 17 as droplet precautions rather than droplet and contact precautions was not cited as error by the surveyors. Further, characterizing the precautions as droplet precautions did not detract from the specific precautions ordered, which were consistent with the precautions for MRSA recommended by the CDC, with the addition of the mask, based on the presence of MRSA in Resident 17’s sputum. I note that the surveyors raised no question about the use of goggles and mask or mask and face shield during suctioning of Resident 17, and compliance with preventing transmission via eyes, nose, or mouth, the primary focus of droplet precautions, is not at issue before me.
Based on my review of Petitioner’s policies, transmission-based precautions are always applied to the entire resident room consistent with CDC Guidelines, even when cohorting or placement with a low-risk patient is necessary. Under Petitioner’s contact precautions policy, donning gloves and gown is required upon entering the room or cubicle in which contact precautions are in effect, consistent with CDC recommendations. CMS Ex. 29 at 3. Under Petitioner’s droplet precautions policy, donning a mask is required upon entering the room or cubicle in which the precautions are in effect. CMS Ex. 29 at 5. The CDC states that many factors could affect the distance for droplet transmission; thus,
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the distance of three feet or less is an example of what is meant by a short distance from a patient and is not the sole criteria for deciding when to don a mask. The CDC states that it may be prudent to don a mask when within six to ten feet or upon entry of a patient room, particularly when a highly virulent pathogen may be present. CMS Ex. 59 at 17, ¶ I.B.3.b. Based on my review of the CDC Guidelines and the Kentucky PHPR, it is consistent with those policies and well within Petitioner’s discretion to simply adopt a policy that applies transmission-based precautions to an entire room rather than just a fixed distance from the resident and to require a mask upon entering a room in which droplet precautions are in effect and a gown and gloves when contact precautions are in effect. Petitioner’s policy regarding contact precautions, as reflected on the poster in evidence as CMS Ex. 33, required everyone to clean hands when entering and leaving the room, to follow standard precautions, and to wear a gown and gloves when entering the room. The poster did not specify the use of a mask. CMS Ex. 33 at 2. The poster for droplet precautions required cleaning hands when entering or leaving the room, standard precautions, the use of a mask, and wearing eye protection if a splash or spray was likely. The poster specified that doctors and staff were to use gown, gloves, a mask, and eye protection if contact with body fluids was likely. CMS Ex. 33 at 1. Both posters are subject to conflicting interpretations. According to Petitioner’s standard precautions policy, masks, eye protection, and gowns are only necessary when performing procedures that may generate splashes or sprays. Gloves are required for any direct contact with one suspected of being infected or colonized with MRSA. CMS Ex. 28. Petitioner’s policy that addressed MDROs such as MRSA recommended that masks not be used generally unless there was a risk for splashing body fluids. However, the policy stated that healthy visitors and volunteers are encouraged to wear disposable gowns and gloves during visitation. CMS Ex. 26 at 1, 3. But Petitioner’s policy for implementation of contact precautions is explicit that gloves and gown are to be donned when entering a room in which contact precautions are in effect. CMS Ex. 29 at 3. Petitioner’s droplet precaution policy is also explicit that a mask must be donned when entering a room in which droplet precautions are in effect. CMS Ex. 29 at 5. According to Petitioner’s counsel, Petitioner’s policy was that anybody, including staff and visitors, entering a room with isolation (transmission-based) precautions in effect should wear proper PPE, including mask, gown, and gloves. Petitioner conceded at hearing that if Resident 17’s wife was not wearing her PPE, that would violate Petitioner’s policy. Tr. 615-17.
Petitioner’s policies also clearly required that visitors of residents be educated by staff on the nature of the known or suspect infection and the PPE required for visiting. CMS Exs. 28 at 1, 30 at 1. Healthy visitors to one on contact precautions due to MRSA were to be encouraged to wear disposable gowns and gloves. CMS Ex. 26 at 3. Petitioner had a specific policy entitled “Visitation, Infection Control During.” CMS Ex. 34. The policy provides that family of residents will be educated regarding Petitioner’s infection control practices related to visitation, including standard precautions, hand hygiene, respiratory hygiene, vaccinations, and signs and symptoms of communicable diseases. The policy provides that visitation during transmission-based precautions is permitted, but family
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members providing care or having very close contact with the resident will be trained regarding infection control barriers such as PPE. Signs posted in the facility encourage visitors to use proper hand hygiene upon arrival and departure and cough etiquette/respiratory hygiene. CMS Ex. 34. I interpret Petitioner’s visitation infection control policy to require training of visitors of those residents on transmission-based precautions (specifically, contact and droplet precautions in the case of Resident 17), including the use of gloves, gown, and masks during visitation if there will be close contact, which I construe to be direct contact with the resident. Petitioner’s policies are consistent with the discretion granted by the CDC Guidelines. The CDC says that there is a possibility of transmission of pathogens when a visitor has close patient contact and a determination must be made by the facility regarding the use of PPE based on the level of interaction. CMS Ex. 59 at 65, ¶ II.N.3.b. The CDC specifically notes the necessity for educating family and visitors on the use of PPE when transmission-based precautions are in effect. CMS Ex. 59 at 47-49, ¶ II.C.
On March 6 and 7, 2014, Surveyor Hinson observed Resident 17’s wife in the resident’s room, the only visitor she observed in his room. She testified that she believed that Petitioner had designated Resident 17’s entire room as subject to droplet precautions. She credibly testified that she observed that Resident 17’s wife did not properly don PPE when entering Resident 17’s room on one occasion consistent with the allegations in the SOD. She also testified that she observed Resident 17’s wife with PPE that was not being properly worn, and the wife was observed not to wash her hands or don gloves, consistent with observations recorded in the SOD. Surveyor Hinson also testified that Petitioner’s staff was unable to provide any documentation that Resident 17’s wife had been educated about Resident 17’s MRSA infection and precautions in effect. She testified that in her opinion, other residents were at risk for contracting MRSA because Resident 17’s wife did not properly follow infection control procedures and could spread the pathogen by either her hands or the articles she carried in and out of Resident 17’s room. Tr. 239-43, 248-49, 363-72, 377-80, 425-27, 444, 460. Surveyor Hinson testified that she believed many nursing home residents have compromised immune systems, and the spread of infection can cause harm or death. Tr. 168-69. Surveyor Hinson testified that she was told by R.N. Gensheimer, Petitioner’s infection control nurse, that Resident 17’s wife was educated and reminded frequently about the use of PPE. Tr. 268-73. However, Surveyor Hinson testified that she requested that Petitioner’s staff provide documentation that showed Resident 17’s wife was trained to use PPE, but she was not provided documentation. Tr. 253-54. Surveyor Hinson also testified that Resident 17’s wife told her that she did not understand why PPE was necessary. Tr. 275-78, 283-84.
CMS also presented as evidence documents from Petitioner’s clinical record for Resident 17 obtained by the surveyors during the survey. Those records establish that Petitioner returned from the hospital on February 12, 2014, with a diagnosis of MRSA pneumonia with MRSA in his sputum. Resident 17 was placed on precautions characterized as droplet precautions but that are also consistent with contact precautions to the extent
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gloves and a gown were also required. The infection control care plan listing required PPE was prepared by Resident 17’s IDT on about February 12 and 13, 2014. Laboratory reports show Resident 17’s infection with MRSA continued through March 3, 2014, and more likely than not through the date of the survey that ended on March 7, 2014. Resident 17’s care plan required that the need for isolation be explained to the resident’s family. CMS Ex. 20 at 76, 78, 81, 109-11, 116, 159, 161, 163-66, 173. Resident 17’s care plan did not specifically state what PPE was to be used by family visiting Resident 17 or when. However, Petitioner concedes that its policy was that anybody, including staff and visitors, entering a room with isolation precautions in effect should wear proper PPE, including mask, gown, and gloves. Petitioner conceded that if Resident 17’s wife was not wearing her PPE, that would violate Petitioner’s policy. Tr. 615-17. Records obtained by the surveyors do not show that family was educated regarding Resident 17’s infection, the need for isolation, or the use of PPE.
Following the presentation of the CMS case in chief, Petitioner moved for a judgment on partial findings.
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§ 483.20(k)(3)(ii) (Tag F282). However, this analysis applies equally to the other noncompliance (Tags) at issue in this case.
As already noted, the provisions of the Act that authorize surveys of long-term care facilities and the imposition of enforcement remedies and the Secretary’s regulations at 42 C.F.R. pts 488 and 498 do not specify the allocation of the burden of persuasion on the issue of whether there is noncompliance. However, the Board has adopted an interpretive rule or policy providing for an allocation of the burden of persuasion that requires that CMS come forward with some quantum of evidence sufficient to establish a prima facie case. The Board has stated that “CMS makes a prima facie showing of noncompliance if the evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal.” Evergreene, DAB No. 2069 at 7. The Board has not explained how much evidence, i.e., the quantum of evidence, CMS must produce to establish a prima facie case and to support a decision in its favor, if a petitioner presents no evidence. Typically, in an administrative case, a decision must be based upon sufficient evidence to determine that facts in issue are more likely true than not, i.e., a preponderance of the evidence. But the Board has suggested, but never clearly stated, that CMS can make a prima facie showing based on a mere allegation, a scintilla of the evidence, or some quantum of evidence less than a preponderance of the evidence. In addressing the burden of coming forward with evidence and the burden of persuasion, the various appellate panels of the Board focus upon imposing the burden of persuasion upon the nongovernmental party, stating that “[i]f CMS makes this prima facie showing, then the SNF must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.” Id. (citations omitted). The Board has also stated that “the SNF has the burden of persuading the ALJ that it was in substantial compliance, provided CMS has made a prima facie showing of noncompliance.” Id. at 8. The Board has stated that “CMS does not have the burden of proving that the SNF was not in substantial compliance.” Id.
But the Board has not clarified exactly how much evidence CMS is required to produce to meet its burden to make a prima facie showing or what happens if CMS fails to meet the quantum requirement. It seems logical to require CMS to present some evidence that Petitioner violated a regulation and that the violation posed a risk for more than minimal harm in order to make a prima facie showing of noncompliance. It seems illogical that CMS does not have to show any evidence of noncompliance in order to make a prima facie showing, unless, of course, the Board’s position is that a mere allegation by the surveyors is sufficient to meet the CMS burden to make a prima facie showing. An appellate panel of the Board has said that “[w]eighing the evidence is appropriate only for determining whether the SNF has carried its ultimate burden of persuasion, not for determining whether CMS has made its prima facie case.” Id. (footnote omitted.) Deciding whether or not CMS has presented sufficient evidence to meet its burden to make a prima facie showing certainly must involve weighing the evidence presented by
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CMS, unless of course the Board is willing to accept a mere allegation by CMS to be sufficient to meet the CMS burden. In Evergreene, the Board commented that because the SNF challenged whether or not CMS carried its initial burden of making a prima facie showing, the ALJ in that case was required to address that issue applying the “appropriate burden of proof framework.” Id. at 8 n.8. But the Board commented that had the SNF not challenged whether CMS made a prima facie showing the ALJ would just resolve the ultimate issue of whether Petitioner proved substantial compliance by a preponderance of the evidence. The Board’s comments suggest that whether or not CMS made a prima facie showing is not even at issue unless Petitioner specifically preserves a challenge to the prima facie case, such as Petitioner attempted in this case. The Board in Evergreene did not actually evaluate the adequacy of the CMS prima facie case or give any guidance for how such evaluation might be conducted. In St. Joseph Villa Nursing Ctr., DAB No. 2210 (2008), a case in which CMS failed to deliver and offer any evidence in open court, an appellate panel of the Board stated in remanding the case that “the legal sufficiency of CMS’s case does not depend solely upon the evidence submitted by CMS itself.” St. Joseph Villa, DAB No. 2210 at 3. In Sunshine Haven Lordsburg, the Board repeated its prior view that in an ALJ hearing “CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.” DAB No. 2456 at 3 (2012). But the Board presented no insight as to how much evidence “is sufficient.” That appellate panel of the Board did reject the notion that CMS might be required to show that noncompliance was more likely than not, commenting that the preponderance of the evidence standard simply does not apply to the CMS burden of making a prima facie showing of noncompliance. Id. at 3 n.2.
In addition to a regulatory violation or deficiency, CMS must show that the deficiency posed a risk for more than minimal harm in order for there to be noncompliance that will support the imposition of an enforcement remedy. 42 C.F.R. §§ 488.301 (substantial compliance means that no deficiency poses a “greater risk to resident health or safety than the potential for causing minimal harm,” and noncompliance “means any deficiency that causes a facility not to be in substantial compliance”); 488.330(b)(2) (certification of noncompliance requires enforcement action); 488.400 (section 1819(h) of the Act specifies remedies that may be used when a SNF is not in substantial compliance with participation requirements); 488.402(b) (enforcement remedies are imposed based on noncompliance); 488.404-.408 (no enforcement remedy authorized if a deficiency poses minimal harm with no actual harm). Therefore, CMS has the initial burden, as part of its prima facie case, to show that a regulatory violation poses a greater risk to resident health and safety than the potential for causing minimal harm. 42 C.F.R. § 483.301 (definition of substantial compliance); see Jennifer Matthew Nursing & Rehab. Ctr., DAB No. 2192 at 20 n.12 (2008) (the Board recognized that CMS has the initial burden of making a prima facie showing but declined to define what showing is required to meet the burden).
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Based on my review of the evidence offered by CMS as analyzed above, I conclude that CMS has a made a prima facie showing of a violation of 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282), the violation posed a risk for more than minimal harm, and the violation amounted to noncompliance. Furthermore, I conclude based on the CMS evidence that CMS established its prima facie case based on more than mere allegations and far more than a scintilla of the evidence. I conclude that considering the CMS evidence only, without consideration of any rebuttal by Petitioner, CMS has established by a preponderance of the evidence its prima facie showing of a regulatory violation and that that violation posed a risk for more than minimal harm. Resident 17’s care plan established on February 12 and 13, 2014, required droplet isolation precautions in addition to standard precautions. Resident 17’s family was to be educated regarding the infection precautions implemented. Clinical records of Resident 17 obtained by the surveyors do not show that Resident 17’s wife or other family was educated about the resident’s infection or the isolation precautions required. Surveyor Hinson credibly testified that she observed Resident 17’s wife not complying with isolation precautions. It is important to note that the regulatory violation under this F Tag is not the failure of Resident 17’s wife to properly don and wear PPE, but the failure of Petitioner to fulfill the requirement of Resident 17’s care plan. I accept the surveyor’s testimony that the failure to fulfill the care plan requirement to ensure Resident 17’s wife was educated as to the nature of Resident 17’s infection and the requirement to use PPE posed a risk for more than minimal harm to Petitioner’s residents. Surveyor Hinson credibly testified that the wife’s noncompliance with PPE posed the risk that she could transmit MRSA outside the resident’s room. Tr. 248-49. Her testimony is consistent with the CDC Guidelines which indicate that MRSA is an infectious pathogen that increases morbidity and mortality in long-term care facilities, particularly among the elderly and that contact precautions are appropriate to prevent the spread of MRSA outside isolation. CMS Ex. 1 at 24, 26, 48-49; Tr. 419, 425-27.
Because I conclude that CMS made a prima facie showing, denial of Petitioner’s motion for judgment on partial findings on grounds CMS failed to make a prima facie case is appropriate. Therefore, the burden is upon Petitioner to rebut that prima facie showing of noncompliance or establish an affirmative defense by a preponderance of the evidence. Petitioner fails to meet its burden.
Petitioner’s evidence does not show that it was more likely than not that Resident 17’s family was educated as required by the resident’s care plan. Nurse notes placed in evidence by Petitioner (P. Ex. 6) do not show that, prior to March 8, 2014, the day after the survey ended, nursing staff educated Resident 17’s wife or other visitors about required infection and isolation precautions that visitors were expected to observe. Petitioner offered no staff notes that record observations of visitors in PPE. P. Ex. 6 at 6-16. A nurse note dated March 8, 2014 at 9:00 a.m. shows that staff was attempting to educate Resident 17’s wife and the note records that she stated that was the first she heard the information about isolation and precautions. The nurse note indicates that when the
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nurse left the room, the resident’s wife was wearing gown, gloves, and mask and her purse and lunch bag were wrapped in a plastic bag. The nurse note states when a daughter of Resident 17’s wife was called she described the correct use of PPE but the daughter stated that her mother was getting more forgetful. The nurse note states that the daughter committed to help monitor her mother, but there is no evidence showing how often the daughter actually visited Resident 17 with her mother so the value of that commitment is impossible to judge. P. Ex. 6 at 17. A nurse note dated March 7, 2014, which is entered in the clinical record following the nurse notes from March 8, 2014, states that the wife was observed wearing gown, gloves, and mask at times and that the nurse instructed her to wear the PPE at all times when in the room. Why this note is out of sequence is not explained by the entry itself; for example, there is no notation that the note was a late entry. P. Ex. 6 at 18. A nurse note dated March 9, 2014, reflects another conversation with Resident 17’s wife about using PPE and her compliance. P. Ex. 6 at 19. The notes show that on March 14, 2014, the order for droplet isolation was changed to using only standard precautions, and both the wife and her daughter were educated. P. Ex. 6 at 21. The fact that these remedial actions were taken by Petitioner after the survey is not considered an admission by Petitioner that there was noncompliance. However, had Petitioner documented such actions prior to the survey, it is less likely that Petitioner would have been found in violation of the regulation.
Margaret Downs, Petitioner’s respiratory therapist, testified that in her opinion, Resident 17’s wife was cognitively intact. Tr. 675-76. She testified that after Resident 17 was placed on contact precautions she discussed with his wife the need for the precautions, and the wife agreed to comply. Ms. Downs was not specific as to when she discussed infection precautions with Resident 17’s wife, and no notes she created were offered as evidence to show when the discussion occurred. Tr. 678-79. Ms. Downs recalled one occasion when she observed Resident 17’s wife without gloves, and when challenged, the wife explained she had just washed her hands and was preparing to put gloves on. Tr. 681. However, Ms. Downs did not testify as to when this incident occurred.
DON Tomes testified that Petitioner’s infection control policy requires that visitors to a room with contact precautions in effect are to follow the same PPE requirements as staff. Tr. 817-20. She testified that prior to the survey she never received a report that Resident 17’s wife did not wear PPE properly. She testified that she was unaware of staff having to give the wife frequent reminders to use PPE. After the survey, she personally educated Resident 17’s wife about the correct use of PPE and ensured that staff was supervising the wife’s visits. Tr. 765, 768-70, 798-804, 806.
ADON Busha testified that Resident 17’s wife had a regular routine of arriving at the facility, going straight to Resident 17’s room, and spending the day with him in his room. She testified that the wife did not interact with other residents. She testified she never observed and staff never reported to her that the wife was noncompliant with PPE
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requirements. The first she heard about the wife being noncompliant with PPE was during the survey. Tr. 825-34.
Nurse Gensheimer, Petitioner’s infection control nurse and nurse educator, testified that Resident 17’s wife was educated regarding infection control by Marc Kennedy, a transitional care nurse, and he reported to her that the education had been done. She testified that she knew other nurses and staff reminded Resident 17’s wife to wear PPE. She testified that prior to the survey she received no complaints that the wife was not wearing PPE correctly. Tr. 869-77. Nurse Gensheimer did not testify as to when Nurse Kennedy educated Resident 17’s wife or when nurses and staff reminded Resident 17’s wife about using PPE. Petitioner did not offer the testimony of Nurse Kennedy or any contemporaneous record of his education of Resident 17’s wife. Nurse notes do not reflect training or reminders prior to the survey. P. Ex. 6 at 6-17. Petitioner has presented no other documents to clarify when the education and reminders to which Nurse Gensheimer testified actually occurred.
CNA Sweeney testified in the state administrative hearing that he saw Resident 17’s wife in the resident’s room with her gloves off or some other defect in her PPE, and he reminded her to properly wear the PPE. He testified that he reported the problem to his nurse supervisor. His testimony suggests more than one such incident. P. Ex. 16 at 211-14. Although CNA Sweeney’s reminder to Resident 17’s wife to properly wear PPE might be considered to be education, CNA Sweeney did not testify to when the reminders occurred. He was not called as a witness in this proceeding, and no documents recording his reminders to Resident 17’s wife are in evidence.
Considering the whole record, there is evidence that Petitioner did provide Resident 17’s wife education regarding the resident’s infection and the need for infection control, but the evidence shows the education more likely than not occurred after the survey identified the issue. The documentary evidence and testimony do not show that the education of family required by Resident 17’s care plan actually occurred between Resident 17’s return to Petitioner and the survey.
Petitioner has also failed to rebut the prima facie showing that the regulatory violation posed a risk for more than minimal harm to Petitioner’s residents. The CDC describes MRSA as an epidemiologically important organism and deserving of special attention in healthcare facilities due to its resistance to first-line therapies and increased morbidity and mortality. CMS Ex. 59 at 21-22, ¶ I.C.1. There is no dispute that MRSA poses a risk for serious harm or death for residents of long-term care facilities. CMS Exs. 52-58. Petitioner introduced as evidence the article published August 21, 2014, in The Lancet. The article, titled “Screening and isolation to control methicillin-resistant Staphylococcus aureus: sense, nonsense, and evidence,” acknowledges the importance of hand hygiene in preventing the spread of MRSA but suggests that the efficacy of isolation and its negative effects upon patients require more study. However, the article recognizes that contact
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isolation remains the established standard for preventing MRSA from spreading. P. Ex. 11. The article questions the efficacy of isolation precautions in controlling the spread of MRSA compared to the negative impact of such precautions upon resident quality of life. I do not find, however, that the article or questions raised about the efficacy of isolation in dealing with MRSA outweigh the CDC Guidelines’ recommendation that contact precautions be used in dealing with MRSA. CMS Ex. 59 at 84-86, ¶ V.B. Furthermore, the Lancet article does not undermine the CDC’s position that spreading MRSA poses a health risk with increased morbidity and mortality in a nursing home environment. Contact precautions with standard precautions, which include good hand hygiene, remain the standard of care for minimizing or preventing the spread of MRSA. Failure to ensure that the care plan requirement to educate Resident 17’s wife on the cause of his infection and the required infection control precaution posed a risk for spreading MRSA, and Petitioner has not presented competent evidence to show that the risk was not for more than minimal harm for Petitioner’s residents.
Accordingly, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282); the violation posed a risk for more than minimal harm; and Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.
9. CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.65 (Tag F441).
10. The violation of 42 C.F.R. § 483.65 (Tag F441) posed a risk for more than minimal harm and amounted to noncompliance.
11. Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.
a. Facts
The facts found under Conclusions of Law 1 through 8 are applicable to Conclusions of Law 9 through 11.
b. Analysis
The surveyors allege under Tag F441 that Petitioner failed to maintain an effective infection control program. The surveyors cited examples of Resident 17; they observed breaks in hand hygiene when staff provided care; staff’s failure to use gloves; infection control violations during the administration of eye medication; improper handling of laundry; and improper use of PPE. CMS Ex. 1 at 45. The example of Resident 17 establishes noncompliance and it is not necessary to discuss the other examples cited by the surveyors. The surveyors allege that Petitioner’s failure to maintain an effective
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infection control program in violation of 42 C.F.R. § 483.65 posed immediate jeopardy to Petitioner’s residents. CMS Ex. 1 at 44.
The infection control regulation requires:
The facility must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of disease and infection.
(a) Infection control program. The facility must establish an infection control program under which it—
(1) Investigates, controls, and prevents infections in the facility;
(2) Decides what procedures, such as isolation, should be applied to an individual resident; and
(3) Maintains a record of incidents and corrective actions related to infections.
(b) Preventing spread of infection.
(1) When the infection control program determines that a resident needs isolation to prevent the spread of infection, the facility must isolate the resident.
(2) The facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease.
(3) The facility must require staff to wash their hands after each direct resident contact for which handwashing (sic) is indicated by accepted professional practice.
(c) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.
42 C.F.R. § 483.65.
Surveyor Hinson testified that Petitioner was not cited for failure to have adequate infection control policies. Tr. 354-58, 396, 407. Her testimony is consistent with the SOD. CMS Ex. 1 at 44-59.
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Based on the facts I have found related to Resident 17, I conclude that CMS has made a prima facie showing of violation of 42 C.F.R. § 483.65 because Petitioner failed to maintain its infection control program that required education of family about a resident’s infection and infection control measures. Petitioner’s standard precautions policy required that residents and family be provided information about standard precautions and the prevention of infections. CMS Ex. 28. Petitioner’s MDRO policy required that healthy visitors and volunteers be encouraged to wear disposable gloves and gowns during visitation. P. Ex. 8 at 10. Petitioner’s hand hygiene policy provided that residents, family, and visitors were to be encouraged to practice hand hygiene by the distribution and posting of materials. P. Ex. 8 at 15-16. Petitioner’s transmission-based precautions policy required posting of a sign on or near a resident room door to inform staff and visitors of the type of precautions required. P. Ex. 8 at 18-23. Petitioner’s policy regarding the initiation of transmission-based precautions requires that the resident or his or her representative be educated about the reason for the precautions; a sign is to be posted on the room door advising of the precautions in effect and the need to consult a nurse before entering; and PPE is to be maintained near the resident room so that anyone entering the room can access the correct PPE. CMS Ex. 30 at 1. Petitioner’s infection control policies requiring education of family and visitors about the proper use of PPE when transmission-based precautions are required are consistent with the CDC Guidelines. CMS Ex. 59 at 47-49, ¶ II.C. Clinical records of Resident 17 obtained by the surveyors do not show that Resident 17’s wife or other family was educated about the resident’s infection or the isolation precautions required. The absence of clinical records entries is consistent with the report of Resident 17’s wife to Surveyor Hinson that she did not understand the need for infection control precautions. Tr. 275-78, 283-84.
In addition to a regulatory violation or deficiency, CMS must generally show as part of its prima facie case that the deficiency posed a risk for more than minimal harm in order for there to be noncompliance that will support the imposition of an enforcement remedy. 42 C.F.R. §§ 488.301, 488.330(b)(2), 488.400, 488.402(b), 488.404-.408; Jennifer Matthew Nursing & Rehab. Ctr., DAB No. 2192 at 20 n.12. However, for this alleged noncompliance under Tag F441, CMS need not present evidence to show that there is a risk for more than minimal harm. For a deficiency cited under Tag F441, the SOM provides as follows regarding the severity of an infection control deficiency:
Severity Level 1: No actual harm with potential for minimal harm
The failure of the facility to provide appropriate care and services for infection control practices places the resident at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement.
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SOM app. PP, Tag F441 (rev. 55, eff. Dec. 2, 2009). Therefore, as a matter of policy the Secretary or CMS has declared that a deficiency under Tag F441 poses a risk for more than minimal harm. It is within the Secretary’s discretion to make the determination that violation of infection control practices per se places residents at risk for more than minimal harm. Act § 1819(f)(1) (“duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . and the enforcement of such requirements, are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”). Whether the SOM language should be interpreted to mean that any failure to follow infection control practices is per se noncompliance, and not subject to rebuttal; or whether it should be treated as establishing a rebuttable presumption of noncompliance, need not be resolved in this case. If failure to follow infection control practices is noncompliance per se, Petitioner cannot prevail in this case on the citation of noncompliance under Tag F441, as the facts show that Resident 17’s wife was not educated as to Resident 17’s infection or the need for infection control in violation of Petitioner’s infection control policies. If failure to follow infection control policy triggers a rebuttable presumption of noncompliance, Petitioner has not rebutted the presumption in this case. Nurse notes placed in evidence by Petitioner (P. Ex. 6) do not show that nursing staff educated Resident 17’s wife or other visitors about required infection and isolation precautions that visitors were expected to observe until March 8, 2014, the day after the survey ended. Petitioner has presented no staff notes recording observations of visitors in PPE that would show monitoring of compliance with infection control procedures required by Petitioner’s policies and recommended by CDC Guidelines. P. Ex. 6 at 6-16. Petitioner’s evidence does not show that it was more likely than not that Resident 17’s family was educated as required by the resident’s care plan and Petitioner’s infection control policies. Further, Petitioner’s evidence does not show that it is more likely than not that the violation of Petitioner’s infection control policy that required education of the family did not pose a risk for more than minimal harm to Petitioner’s residents.
Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.65; the violation posed a risk for more than minimal harm; and Petitioner has failed to rebut the prima facie showing of noncompliance.
12. CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75 (Tag F490).
13. The violation of 42 C.F.R. § 483.75 (Tag F490) posed a risk for more than minimal harm and amounted to noncompliance.
14. Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.
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a. Facts
The facts found under Conclusions of Law 1 through 8 are applicable to Conclusions of Law 12 through 14.
b. Analysis
The regulation requires that Petitioner administer its facility “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 Board has held that a determination that a SNF failed to comply substantially with 42 C.F.R. § 483.75 may be derived from findings that the SNF was not in substantial compliance with other participation requirements.” Stone Cnty. Nursing & Rehab. Ctr., DAB No. 2276 at 15 (2009); Life Care Ctr. at Bardstown, DAB No. 2233 at 28 (2009); Britthaven, Inc. d/b/a Britthaven of Smithfield, DAB No. 2018 at 22 (2006).
The surveyors alleged in the SOD that Petitioner failed to be “administered in a manner that used resources effectively and efficiently to ensure the infection control program was implemented to prevent the transmission of highly infectious diseases.” CMS Ex. 1 at 62. The surveyors allege that Petitioner failed to ensure an effective infection control program as there was ineffective monitoring of a visitor to the facility, the wife of Resident 17, who did not comply with infection control requirements, specifically the use of PPE. The surveyors also allege ineffective management of Petitioner based on inconsistent availability of PPE, instances of improper hand hygiene by staff, failure to use gloves when appropriate, breaks in clean technique, and failure to use PPE when handling laundry. As with the prior deficiency citations, I conclude it is only necessary to consider the example of Resident 17 and his wife.
Based on my findings of fact related to the example of Resident 17, I conclude that CMS made a prima facie showing of noncompliance under Tag F490. Resident 17 was on transmission-based precautions. The precautions were characterized by Resident 17’s IDT as droplet precautions, but included as required PPE gown and gloves in addition to a mask for staff and visitors. CMS Ex. 20 at 81, 110-11; CMS Exs. 26, 29, 30, 33; Tr. 615-17. According to Petitioner’s infection control policy and Resident 17’s care plan, donning proper PPE was required for all staff and visitors upon entering the resident’s room. Tr. 615-17. The surveyors did not cite any deficiency based on a finding that Petitioner’s infection control policies were deficient. Tr. 354-58, 396, 407; CMS Ex. 1. Rather, noncompliance was cited based upon surveyor observations of Resident 17’s wife failing to use or incorrectly using PPE; the wife’s assertion that she was not aware of the reason for Resident 17’s isolation and the need for proper use of PPE; and the absence of documentation that the wife had been educated about Resident 17’s infection and the need for proper use of PPE. The surveyors concluded under Tag F490 that while Petitioner had adequate infection control policies, Petitioner failed to effectively and efficiently implement its infection control policies because Petitioner failed to adequately
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monitor the wife’s compliance with infection control procedures to prevent the spread of infection, thereby increasing the likelihood of the spread of infection.
CMS has made a prima facie showing, based on evidence adduced by CMS, that it was more likely than not that Resident 17’s wife was not educated regarding the nature of Resident 17’s infection and the need for proper transmission-based infection control, as required by Resident 17’s care plan and Petitioner’s infection control policies. The observations by surveyors recorded in the SOD and Surveyor Hinson’s testimony regarding her observations of Resident 17’s wife’s failure to use or improper use of PPE on March 6 and 7, 2014, show it was more likely than not that the wife failed to properly use PPE during her nearly daily visits between February 12 and March 7, 2014. CMS Ex. 1 at 24, 26, 48-49; Tr. 419, 425-27. The documents presented by CMS and the testimony of Surveyor Hinson; the absence of documents in Resident 17’s records documenting training and monitoring of Resident 17’s wife; and the fact no documents were given to the surveyors during the survey documenting training and monitoring of Resident 17’s wife show it was more likely than not that Resident 17’s wife was not educated or monitored from the resident’s readmission on February 12, 2014, until the issue was identified by the surveyors. Surveyor Hinson credibly testified that the wife’s noncompliance with PPE posed the risk that she could transmit MRSA outside the resident’s room. Tr. 248-49. Her testimony is consistent with and supported by the CDC Guidelines, which indicate that MRSA is an infectious pathogen that increases morbidity and mortality in long-term care facilities, particularly among the elderly. CMS Ex. 1 at 24, 26, 48-49; Tr. 419, 425-27.
Petitioner has failed to rebut the CMS prima facie case or establish substantial compliance or an affirmative defense by a preponderance of the evidence. Nurse notes placed in evidence by Petitioner (P. Ex. 6) do not show that nursing staff educated Resident 17’s wife or other visitors about required infection and isolation precautions that visitors were expected to observe until March 8, 2014, the day after the survey ended. There are no staff notes recording observations of visitors in PPE that would show monitoring of compliance with infection control procedures required by Petitioner’s policies and recommended by CDC Guidelines. P. Ex. 6 at 6-16. Petitioner’s evidence does not show that it was more likely than not that Resident 17’s family was educated as required by the resident’s care plan and Petitioner’s infection control policies. Further, Petitioner’s evidence does not show that it is more likely than not that the violation of Petitioner’s infection control policy that required education of the family did not pose a risk for more than minimal harm to Petitioner’s residents.
Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75 and the violation posed a risk for more than minimal harm; and Petitioner has failed to rebut the prima facie showing of noncompliance.
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15. CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.75(o) (Tag F520).
16. The violation of 42 C.F.R. § 483.75(o) (Tag F520) posed a risk for more than minimal harm and amounted to noncompliance.
17. Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense.
a. Facts
The facts found under Conclusions of Law 1 through 8 are applicable to Conclusions of Law 15 through 17.
b. Analysis
Every long-term care facility is required to establish a functioning quality assessment and assurance (QA) committee. The regulation requires:
(1) A facility must maintain a quality assessment and assurance committee consisting of—
(i) The director of nursing services;
(ii) A physician designated by the facility; and
(iii) At least 3 other members of the facility’s staff.
(2) The quality assessment and assurance committee—
(i) Meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary; and
(ii) Develops and implements appropriate plans of action to correct identified quality deficiencies.
42 C.F.R. § 483.75(o).
There is no question that Petitioner had established the required QA committee and that it met sufficiently to meet the regulatory requirement. The surveyors allege in the SOD that Petitioner violated this regulation because Petitioner: (1) failed to promptly act upon a mock survey conducted by Petitioner, the results of which were received by Petitioner the third week of February 2014; and (2) Petitioner failed to maintain an effective infection control program. CMS Ex. 1 at 75. Pursuant to 42 C.F.R. § 483.75(o)(4) “[g]ood faith attempts by the [quality assurance] committee to identify and correct quality
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deficiencies will not be used as a basis for sanctions.” I accept that conducting a mock survey was a good faith effort by Petitioner to identify and then correct quality deficiencies. Therefore, I do not consider sanctioning Petitioner for failure to correct the deficiencies cited by the mock survey because they were not corrected as promptly as the state agency or CMS may prefer.
The fact that Petitioner conducted a mock survey does not, however, deter me from considering the specific noncompliance identified by the surveyors during the state agency survey related to Resident 17 and his wife. As explained under Tag F490, Petitioner failed to effectively and efficiently implement its infection control policies because Petitioner failed to adequately monitor Resident 17’s wife’s compliance with infection control procedures to prevent the spread of infection, thereby increasing the likelihood of the spread of infection. Infection control should be an important area of focus for a QA committee in a long-term care facility where, according to the CDC, there are increased morbidity and mortality related to infections, particularly MRSA. I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75(o) and an associated risk for more than minimal harm based on my findings and conclusions under Tag F490.
I conclude that Petitioner has failed to rebut the CMS prima facie case or establish substantial compliance or an affirmative defense by a preponderance of the evidence. Petitioner has presented no evidence that its QA committee was monitoring the implementation of Petitioner’s infection control policies in the case of Resident 17 or any other resident. The testimony of Petitioner’s witnesses at hearing, some of Petitioner’s key staff members, was that they were unaware of any failure of Resident 17’s wife to comply with PPE requirements. However, the testimony of CNA Sweeney in the state proceedings shows that at least he and his supervisor were aware that Resident 17’s wife had difficulty complying with PPE requirements. P. Ex. 16 at 211-14. R.N. Gensheimer testified that she was aware that staff had to remind Resident 17’s wife to wear PPE. But R.N. Gensheimer gave no indication that she identified that the need for reminders may have reflected a problem with the wife’s compliance or indicated that she, as the IP, needed to inquire further. R.N. Gensheimer testified she only became aware of the wife’s noncompliance with PPE when alerted to the fact by the surveyors. Tr. 869-77. DON Tomes testified that she was not even aware of the need to frequently remind Resident 17’s wife to use PPE. Tr. 768-70, 798-804, 806. Because DON Tomes, a required member of Petitioner’s QA committee (42 C.F.R. § 483.75(o)(1)(i)), was unaware of the need to frequently remind Resident 17’s wife to use PPE, she did not raise this possible issue related to effective infection control with the QA committee. I conclude that Petitioner has not shown by a preponderance of the evidence that it was in substantial compliance with the requirement of 42 C.F.R. § 483.75(o) to establish a QA committee that identified and developed and implemented plans to identify quality deficiencies, in this case related to infection control. CDC Guidelines indicate that MRSA is an infectious pathogen that increases morbidity and mortality in long-term care facilities,
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particularly among the elderly. CMS Ex. 1 at 24, 26, 48-49; Tr. 419, 425-27. Petitioner has also failed to show by a preponderance of the evidence that its failure to establish a QA committee that identified quality deficiencies related to infection control, particularly related to MRSA, did not pose a risk for more than minimal harm.
Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75(o); the violation posed a risk for more than minimal harm; and Petitioner has failed to rebut the prima facie showing of noncompliance.
18. The declaration of immediate jeopardy related to the noncompliance based on violations of 42 C.F.R. §§ 483.20(k)(3)(ii), 483.65, 483.75, and 483.75(o) was not clearly erroneous.
The surveyors concluded that the violations of 42 C.F.R. §§ 483.20(k)(3)(ii), 483.65, 483.75, and 483.75(o) posed immediate jeopardy that began February 12, 2014 (CMS Ex. 1 at 1) and was abated on March 10, 2014 (CMS Ex. 3 at 1). CMS proposes to impose a CMP in the higher range of CMPs that may be imposed for immediate jeopardy from February 12 through March 9, 2014 (Jt. Stip. ¶ 8), and that is the period of immediate jeopardy at issue before me. Petitioner’s primary focus in this case is the issue of whether any of the four deficiencies cited posed immediate jeopardy.
Petitioner bears a heavy burden under the regulations when challenging a declaration of immediate jeopardy. Unlike the issue of whether there is noncompliance, the Secretary has by regulation imposed the burden of persuasion on Petitioner to show that the declaration of immediate jeopardy was in error not by a preponderance of the evidence, but by the clearly erroneous standard. The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous. 42 C.F.R. § 498.60(c)(2).
CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination. Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs., 174 F. App’x 932 (6th Cir. 2006)); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab. Ctr.–Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty Commons Nursing & Rehab. Ctr.–Johnson v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). 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. Cal Turner, DAB No. 2384 at 14-15; Liberty Commons, 241 F. App’x 76 at 3-4.
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“Immediate jeopardy” under the regulations refers to “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, 489.3 (emphasis in original). In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy. 42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d). The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management. 42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).
Many appellate panels of the Board have addressed “immediate jeopardy.”
CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous. 42 C.F.R. § 498.60(c)(2); Woodstock Care Center. The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one. See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031 at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent
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mathematical judgments for which there are clear or objectively measured boundaries.” 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994). “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.” Daughters of Miriam Center, DAB No. 2067, at 15 (2007).
The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations. In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:
We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however. As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries. Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior. Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility. While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers. Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts. For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State
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or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.
59 Fed. Reg. 56,116, 56,179 (emphasis added). It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration by adopting the clearly erroneous standard of review. Thus, caution must be exercised to ensure that the Board’s decision in Mississippi Care Center of Greenville; Daughters of Miriam Center, and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard. Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.
In the foregoing quotation from Mississippi Care Center of Greenville, that panel of the Board stated that the clearly erroneous standard means that the “immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.” DAB No. 2450 at 15. Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.” However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Center and other cases do not define the standard. The “clearly-erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed. Black’s Law Dictionary 269 (8th ed. 2004). The Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedures Act (APA). The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe & Prods. of California, Inc. v. Constr. Laborers Pension Trust, 508 U.S. 602, 622 (1993). The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion. Consol. Edison Co. v. Nat’l Labor Relations Bd., 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed. United States v. United States Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622. The clearly
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erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential. In discussing the clearly erroneous standard, the Court stressed the importance of not simply rubber-stamping agency fact-finding. The Court also commented that the APA requires meaningful review.
Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue. A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm. Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19 (2010), (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff’d, Life Care Ctr. Tullahoma v. Sebelius, 453 F. App’x 610 (6th Cir. 2011)). The definition of immediate jeopardy at 42 C.F.R. § 488.301 does not define “likelihood” or establish any temporal parameters for potential harm. Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011). The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard. Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7-8. There is a difference between “likelihood,” as required by the definition of immediate jeopardy, and a mere potential. The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential. Daughters of Miriam Ctr., DAB No. 2067 at 10. Jeopardy generally means danger, hazard, or peril. The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences. Woodstock Care Ctr., DAB No. 1726.
What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301? How does serious injury, harm, or impairment compare with “actual harm?” On the first question the Board recognized in Yakima Valley Sch., DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.
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Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.” Id., (citing Daughters of Miriam Ctr., DAB No. 2067 at 9). In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening. The Board recognized the dichotomy between a serious and non-serious harm, noting that the ALJ stated that a serious harm is outside the ordinary, requiring extraordinary care or having lasting consequences. A serious harm may require hospitalization, result in long-term impairment, or cause severe pain. Conversely, a non-serious harm, injury, or impairment is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain. The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case. The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious. Daughters of Miriam Ctr., DAB No. 2067 at 9.
Applying the clearly erroneous standard to the record before me related to the noncompliance I have found, I have no definite and firm conviction that an error has been committed either by the declaration of immediate jeopardy or the period of immediate jeopardy from February 12 through March 9, 2014. The CDC describes MRSA as an epidemiologically-important organism and deserving of special attention in healthcare facilities, due to its resistance to first-line therapies and increased morbidity and mortality. CMS Ex. 59 at 21-22, ¶ I.C.1. There is no real dispute that MRSA poses a risk for serious harm or death for residents of long-term care facilities. CMS Exs. 52-58. Petitioner has not shown that the determination it did not abate immediate jeopardy until March 10, 2014, is clearly erroneous. In fact, nurse notes placed in evidence by Petitioner show that on March 7, 8, and 9, 2014, Petitioner’s staff was still working to educate and ensure Resident 17’s wife understood the need for and was compliant with use of PPE. P. Ex. 6 at 17-21. I concluded that Petitioner failed to ensure compliance with Resident 17’s care plan and its policy, which required education of his wife about
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his infection and the need for infection control procedures that Petitioner and Resident 17’s IDT thought necessary to impose. I concluded that Petitioner failed to comply with its infection control policies, which are consistent with CDC and Kentucky guidelines for infection control. And I concluded that Petitioner’s management and QA committee failed to monitor compliance necessary to ensure effective infection control. MRSA is a serious threat to the health of elderly long term care facility residents that may cause serious harm or death. Long-term care facilities are required to ensure quality care and minimize the risk for infection through an infection control program that is effectively implemented. Petitioner has failed to effectively implement its infection control program based on the example of Resident 17, subjecting other residents to the risk or acquiring a MRSA infection. I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the noncompliance under 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282), 483.65 (Tag F441), 483.75 (Tag F490), and 483.75(o) (Tag F520) during the period February 12 through March 9, 2014, was clearly erroneous.
19. A CMP of $5,800 per day effective February 12 through March 9, 2014; a $200 per day CMP effective March 10 through March 28, 2014; and a DPNA for the period March 19 through March 28, 2014, are reasonable enforcement remedies.
I have concluded that Petitioner was not in substantial compliance with the participation requirements established by 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282), 483.65 (Tag F441), 483.75 (Tag F490), and 483.75(o) (Tag F520). I have also concluded that Petitioner has not shown clearly erroneous the declaration of immediate jeopardy related to the noncompliance from February 12 through March 9, 2014.
Petitioner did not request review of the following deficiency citations from the survey that ended on March 7, 2014 (CMS Ex. 1); the deficiency citations are administratively final; and the deficiencies are a basis for the imposition of enforcement remedies: 42 C.F.R. §§ 483.10(k), (l) (Tag F174) (s/s D); 483.15(a) (Tag F241) (s/s D); 483.15(h)(2) (Tag F253) (s/s E); 483.25(c) (Tag F314) (s/s D); 483.35(i) (Tag F371) (s/s F); 483.35(i)(3) (Tag F372) (s/s F); 483.60(b), (d), (e) (Tag F431) (s/s D); 483.70(g) (Tag F464) (s/s E); 483.75(j)(1) (Tag F502) (s/s D); and 483.75(l)(1) (Tag F514) (s/s D) (unchallenged deficiencies).
Petitioner did not request review of the following deficiency citations from the survey that ended on March 26, 2014 (CMS Ex. 3); the deficiency citations are administratively final; and the deficiencies are a basis for the imposition of enforcement remedies: 42 C.F.R. §§ 483.10(k), (l) (Tag F174) (s/s D); 483.15(a) (Tag F241) (s/s D); 483.15(h)(2) (Tag F253) (s/s E); 483.20(k)(3)(ii) (Tag F282) (s/s D); 483.25(c) (Tag F314) (s/s D); 483.35(i) (Tag F371) (s/s F); 483.35(i)(3) (Tag F372) (s/s F); 483.60(b), (d), (e) (Tag F431) (s/s D); 483.65 (Tag F441) (s/s E); 483.70(g) (Tag F464) (s/s E);
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483.75(j)(1) (Tag F502) (s/s D); and 483.75(l)(1) (Tag F514) (s/s D) (unchallenged deficiencies).
Petitioner did not request review as to the reasonableness of a $200 per day CMP based on the unchallenged deficiencies for the period February 12 through March 28, 2014; therefore, the issue of the reasonableness of that remedy is administratively final. The unchallenged deficiencies are a basis for the imposition of the enforcement remedy of a DPNA for the period March 19 through March 28, 2014, and the reasonableness of that enforcement remedy has not been specifically challenged by Petitioner.
If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy. 42 C.F.R. § 488.430(a). The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMPs, $50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).
I conclude that a CMP in the higher range of CMPs authorized for immediate jeopardy is appropriate in this case. I conclude that a CMP of $5,800 per day effective February 12 through March 9, 2014, the period of immediate jeopardy, is not unreasonable.
If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e). The limitations are: (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount. In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety. The absence of culpability is not a mitigating factor. The factors that CMS and the state were required to
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consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread. My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me. I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose but my authority is limited by regulation as already explained. I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations. Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14–16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).
Petitioner has a history of deficiency citations related to infection control under Tag F441 by surveys completed in January 2005, June 2006, and July 2009 that allegedly posed a risk for more than minimal harm without actual harm. There is no evidence that an enforcement remedy was imposed based on the past citations of Tag F441 or that there was an ALJ hearing related to those surveys. Petitioner was previously cited for noncompliance under Tag F282 by a survey that ended in May 2008. It was alleged that the noncompliance posed a risk for more than minimal harm with actual harm that did not amount to immediate jeopardy. A civil money penalty was imposed based upon that survey, but there is no evidence of any ALJ hearing related to the survey. CMS Ex. 8. Petitioner has presented no evidence in this case that it is unable to pay the CMP of $5,800 per day for the period February 12 through March 9, 2014. The noncompliance declared to pose immediate jeopardy was serious as it placed residents at increased risk for MRSA infection. Petitioner was culpable particularly since at least some staff members were aware of the diminished capacity of Resident 17’s wife but Petitioner failed to monitor her compliance with PPE or attempt additional interventions to ensure she complied with infection control requirements and minimize the known risk for exposing other residents to MRSA.
I conclude that the CMP of $5,800 per day proposed by CMS for the days of immediate jeopardy from February 12 through March 9, 2014, is reasonable.
20. Other defenses and issues raised by Petitioner are without merit or are not within my authority to decide.
a. Affirmative Defenses of Res Judicata or Issue Preclusion and Allocation of the Burden of Persuasion
On November 19, 2014, a Commonwealth of Kentucky Hearing Officer issued “Findings of Fact, Conclusions of Law and Final Order” in the matter of Signature Healthcare of
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East Louisville following a hearing conducted on August 19 and October 3, 2014. The Hearing Officer’s decision reflects that the parties in the case were the Commonwealth of Kentucky, Cabinet for Health and Family Services, Office of the Inspector General (OIG) (the state agency in this case) and the Petitioner in this case. The United States, the Secretary, and CMS were not parties to and were not represented by counsel in the proceedings. P. Ex. 17 at 1. The Hearing Officer considered the findings and conclusions of the survey completed by the state agency on March 7, 2014, and much of the same documentary evidence and witness testimony considered in this case. P. Ex. 17 at 4-10. The Hearing Officer specifically considered the alleged violation of a Kentucky administrative regulation that correlated to Tag F441 as alleged based on the same SOD for the survey that ended on March 7, 2014. P. Ex. 18 at 13-14, ¶¶ 54-55. The Hearing Officer had jurisdiction pursuant to a Kentucky statute and regulation. P. Ex. 18 at 14-15. The Hearing Officer considered specifically whether the allegation against Petitioner as documented in this case under Tag F441 (CMS Ex. 1 at 44-59) constituted a Type A Citation under Kentucky law, i.e., whether the alleged violation presented an imminent danger to any of Petitioner’s residents with a substantial risk that death or serious mental or physical harm may occur to a resident. P. Ex. 18 at 14-15. The Hearing Officer states that under the Kentucky statute, the OIG is burdened to prove the Type A Citation by a preponderance of the evidence. The Hearing Officer concluded that the OIG failed to meet its burden. P. Ex. 18 at 15. Specifically, the Hearing Officer determined that he could not conclude that Resident 17’s wife’s failure to comply with droplet precautions or the failure to properly comply with PPE requirements by staff constituted an imminent danger to other residents or created a substantial risk that death or serious mental or physical harm would result for any resident. P. Ex. 18 at 16-17. The Hearing Officer reversed the Type A Citation issued by the OIG.
Petitioner uses the Hearing Officer decision to challenge both the Board’s view on the correct allegation of the burden of persuasion in cases subject to 42 C.F.R. pt. 498 and to raise the affirmative defense of res judicata or issue preclusion (collateral estoppel).
Petitioner argues that the Hearing Officer decision proves that the allocation of the burden of persuasion clearly can impact the outcome of a case. P. Br. at 5-8. In the Kentucky proceeding, the state agency bore the burden to prove by a preponderance of the evidence noncompliance and that it amounted to something akin to immediate jeopardy. Under the Board’s allocation of the burden of persuasion, CMS has to make a prima facie showing of a regulatory violation and that there exists a risk for more than minimal harm. But, if CMS makes its prima facie showing by whatever quantum of evidence is required, Petitioner is burdened to show that it was in substantial compliance by a preponderance of the evidence. By regulation, Petitioner is burdened to show that the level of noncompliance found by CMS is clearly erroneous, a much stricter standard than the preponderance of the evidence standard. 42 C.F.R. § 498.60(c)(2). Petitioner is correct that under the Kentucky scheme the state agency bore the heavier burden to show
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noncompliance while under the Board’s scheme Petitioner bears the heavier burden. I have no authority to ignore the requirement of the regulation.
Petitioner argues that the allocation of the burden of persuasion in this case, according to the rationale of the Board in the prior decisions cited above, violates the Administrative Procedures Act, 5 U.S.C. § 551 et. seq., specifically 5 U.S.C. § 556(d). P. Br. at 7-8; RFH at 5. Pursuant to the scheme for the allocation of burdens adopted by the Board in its prior cases, CMS bears the burden to come forward with the evidence and to establish a prima facie showing of the regulatory violations alleged in this case by a preponderance of the evidence. If CMS makes its prima facie showing, Petitioner has the burden of coming forward with any evidence in rebuttal and the burden of showing by a preponderance of the evidence that it was in substantial compliance with program participation requirements. Petitioner bears the burden to establish by a preponderance of the evidence any affirmative defense. The allocation of burdens suggested by the Board is not inconsistent with the requirements of 5 U.S.C. § 556(d), as CMS is required to come forward with the evidence that establishes its prima facie case.
I re-examine in each case the rationale of the Board for its interpretive rule allocating the burden of persuasion. I see no reason to upset the allocation as described by the Board given that I am satisfied that the CMS prima facie case is supported by a preponderance of the evidence, and Petitioner has not rebutted the CMS case by a preponderance of the evidence or established an affirmative defense.
Petitioner also argues that the affirmative defense of res judicata or collateral estoppel (issue preclusion) should be available to Petitioner based on the Kentucky Hearing Officer decision. P. Br. at 8-9; Tr. 85-107. I disagree. Collateral estoppel is an affirmative defense that bars a party from re-litigating an issue determined against that party in a prior case. Black’s Law Dictionary 279 (8th ed. 2004). Res judicata is “[a]n affirmative defense barring the same parties from litigating a second lawsuit on the same claim, or any other claim arising from the same transaction or series of transactions and that could have been – but was not – raised in the first suit.” Id. at 1336-37. The parties before the Kentucky Hearing Officer were Petitioner and the state agency, not CMS. The state proceeding was related to enforcement of state law, not the Act and the Secretary’s regulations. The decision of the Kentucky Hearing Officer turned on the state law allocation of the burden of persuasion, which is different from the allocation applicable in this case. Under these circumstances, the prior state decision does not provide Petitioner an affirmative defense.
b. Regulatory Factors Related to Enforcement Remedies Are Reviewed De Novo
Petitioner also argues that the Medicare Act is violated, and Petitioner is deprived of due process, if CMS is not required to submit evidence to prove it considered the regulatory
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criteria established by 42 C.F.R. §§ 488.404 and 488.438(f) in determining enforcement remedies. RFH at 5. I reviewed the evidence related to the regulatory factors de novo and perceive no prejudice to Petitioner because I did not require CMS to submit evidence related to its consideration of the regulatory factors.
III. Conclusion
For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from February 12 through March 28, 2014. There is a basis for the imposition of the following enforcement remedies, which are reasonable: a $5,800 per day CMP effective February 12 through March 9, 2014; a $200 per day CMP effective March 10 through March 28, 2014; and a DPNA for the period March 19 through March 28, 2014.
/s/
Keith W. Sickendick Administrative Law Judge