SUBJECT:

United Presbyterian Residence

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I decide that the Centers for Medicare & Medicaid Services (CMS) is authorized to impose a denial of payments for new admissions (DPNA) for each day of a period that began on July 1, 2001, and which ran through August 16, 2001, against Petitioner, United Presbyterian Residence.

I. Background

On March 13, 2001, the New York State Department of Health (NY state agency) surveyed Petitioner in order to determine whether Petitioner was complying with federal participation requirements. As a result of the March 13, 2001 survey, the NY state agency found that Petitioner was not complying substantially with federal participation requirements. A post survey revisit of the facility was conducted from May 21 through May 23, 2001. The NY state agency determined that Petitioner remained out of compliance. The revisit survey findings included "G" level deficiencies. Five of the seven deficiencies cited at the time of the May 23 revisit survey had been cited during the March 13 survey, although the bases for the deficiencies were different.

CMS determined to impose remedies against Petitioner based on the findings that were made by the NY state agency. By letter dated June 15, 2001, CMS determined to impose a DPNA effective July 1, 2001, and notified Petitioner that Petitioner's provider agreement would be terminated effective September 9, 2001, if Petitioner had not achieved substantial compliance by that date.

Petitioner submitted a Plan of Correction (POC) with respect to the deficiencies found during the May 23, 2001 survey. The latest date that Petitioner alleged compliance on the POC was June 22, 2001. CMS Ex. 3.

On August 17, 2001, the NY state agency conducted a second revisit of the facility. The NY state agency determined that Petitioner was back in substantial compliance as of August 17, 2001. By letter dated September 4, 2001, CMS informed Petitioner that it was back in compliance with federal regulations as of August 17, 2001. Therefore, the DPNA imposed effective July 1, 2001, lasted until August 16, 2001, and the termination was rescinded.

On October 22, 2001, more than four months after the June 15, 2001 notice, Petitioner filed a hearing request appealing the imposition of the DPNA imposed as a result of the March 13, 2001 and May 23, 2001 surveys. CMS filed a motion to dismiss this matter based on Petitioner's failure to submit a timely hearing request By Ruling dated April 18, 2003, I granted in part CMS's motion to dismiss this matter based on Petitioner's failure to submit a timely hearing request. I found that Petitioner did not file a request for hearing within 60 days of the June 15, 2001 notice as required by the regulations. See Nursing Inn of Menlo Park, DAB CR799 (2001), aff'd, Nursing Inn of Menlo Park, DAB No. 1812 (2002). I found that Petitioner did not preserve its right to a hearing on the issue of whether Petitioner was in compliance with federal participation requirements which formed the bases for the remedies imposed in CMS's June 15, 2001 notice letter. Nor did I find that Petitioner had shown good cause for an extension to file a hearing request. I also denied Petitioner's request to remand this matter to CMS. However, CMS issued a second notice letter on September 4, 2001, in which CMS stated that Petitioner had achieved substantial compliance and that the DPNA imposed against Petitioner effective July 1, 2001, was lifted effective August 17, 2001, the date the second revisit survey was conducted. Petitioner's October 22, 2001 hearing request was filed within 60 days of CMS's September 4, 2001 notice letter. Because CMS's September 4, 2001 letter provided Petitioner with an end date to the DPNA remedy, I found that Petitioner's request for hearing did preserve its right to argue that it had achieved compliance on a date earlier than August 17, 2001, based on the analysis set forth by the Departmental Appeals Board (DAB) in Mimiya Hospital, DAB No. 1833 (2002).

Therefore, in my April 18, 2003 Ruling, I limited the scope of this hearing, so that while Petitioner is precluded from contesting the initial deficiency findings, Petitioner has preserved the right to prove that compliance was achieved at a date earlier than August 17, 2001.

By Order dated June 16, 2003, I noted that the parties had agreed to proceed on written submissions and I set a briefing schedule. CMS submitted 29 exhibits (CMS Exs. 1 - 29). Petitioner submitted 27 exhibits (P. Exs. 1 - 10, P. Exs. 12 - 24, P. Ex. 26, and P. Exs. 28 - 30). Petitioner's exhibits 11, 25, and 27 were withdrawn. Neither party objected to my receiving any of these exhibits into evidence, and therefore, I admit into evidence CMS Exs. 1 - 29, P. Exs. 1 - 10, P. Exs. 12 - 24, P. Ex. 26, and P. Exs. 28 - 30.

II. Applicable Law and Regulations

Petitioner is considered a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act vest the Secretary with authority to impose penalties against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, 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. Part 488 of 42 C.F.R. provides that facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10 - 488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300 - 488.335. A survey's findings are presented in a Statement of Deficiencies, which identifies each violation of (or instance of noncompliance with) a participation requirement. See State Operations Manual (SOM) Appendix (App.) P, Chapter (Ch.) IV. Deficiencies are identified by the survey agency using "tags" that correspond to the participation requirements in 42 C.F.R. Part 483. Id.

Based on the determination as to scope and severity of deficiencies and other relevant factors, CMS, with recommendations from the state, may select among available remedies. 42 C.F.R. �� 488.404, 488.406, and 488.408. The remedies that the Act and regulations specify "with respect to a finding that a facility has not met an applicable requirement," include a DPNA, civil money penalties, and termination of the facility's agreement to participate in Medicare. Sections 1819(h)(2)(B), 1919(h) of the Act; 42 C.F.R. �� 488.400, 488.406, 488.408, and 488.417. A DPNA belongs to a class of remedies that must be imposed when there are "[w]idespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy" or "[o]ne or more deficiencies that constitute actual harm that is not immediate jeopardy." 42 C.F.R. � 488.408(d)(2)(i) and (ii). Additionally, a DPNA may be imposed for any deficiency, except when a facility is in substantial compliance. 42 C.F.R. �� 488.408(d)(3), 488.417; Desert Hospital, DAB No. 1623, at 5 - 6, n.4 (1997). A DPNA continues until either "(1) The facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit;" or "(2) CMS or the State terminates the provider agreement." 42 C.F.R. �� 488.454(a), 488.417(d); section 1819(h)(3) of the Act. A facility may appeal a certification of noncompliance leading to an enforcement remedy but not the choice of remedy. 42 C.F.R. � 488.408(g)(1), (2).

The regulations define the term "substantial compliance" to mean "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.

If a survey reveals that a facility is not in "substantial compliance" with federal participation requirements, the facility must submit a POC for approval by the survey agency. 42 C.F.R. �� 488.402(d), 488.408(f). Even if the POC is approved, the facility may not be regarded as in substantial compliance until the survey agency determines, following an onsite revisit or other means of verification, that the deficiency no longer exists. 42 C.F.R. � 488.440(h); SOM App. P, Ch. IV � 7316.

The Act and regulations make a hearing before an Administrative Law Judge (ALJ) available to a long-term care facility against whom CMS has determined to impose a DPNA. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8^th Cir. 1991).

An affected party entitled to a hearing under 42 C.F.R. � 498.5 may file a request for hearing. It must be in writing and filed "within 60 days from receipt of the notice of initial, reconsidered, or revised determination . . . ." 42 C.F.R. � 498.40(a)(2). Additionally, the request for hearing must identify the specific issues, and the findings of fact and conclusions of law with which the affected party disagrees. 42 C.F.R. � 498.40(b).

III. Issue, findings of fact and conclusions of law

A. Issue

The sole issue is the date when Petitioner came into compliance with federal participation requirements. Petitioner does not dispute that CMS may deny Petitioner payments for new admissions for the period that began on July 1, 2001, and which ran through August 16, 2001, if Petitioner was not complying substantially with participation requirements during this period. Petitioner contends that it achieved substantial compliance by June 22, 2001, before the first day that the DPNA became effective.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading and I discuss each Finding in detail.

1. CMS established a prima facie case that Petitioner failed to comply substantially with federal participation requirements prior to August 17, 2001.

As I discuss above, I found that Petitioner did not preserve its right to a hearing on the issue of whether Petitioner was in compliance with federal participation requirements which formed the bases for the remedies imposed in CMS's June 15, 2001 notice letter. Those deficiency findings, therefore, are final and establish that Petitioner was not complying substantially with federal participation requirements as of March 13, 2001 or May 23, 2001.

The NY state survey agency conducted a second revisit survey of Petitioner on August 17, 2001. It was at the August survey that the surveyors concluded that Petitioner finally attained substantial compliance with participation requirements.

Petitioner's noncompliance on March 13, 2001 and May 23, 2001, establishes a presumption that Petitioner was not complying on dates thereafter. CMS has no affirmative burden to offer additional evidence to prove that Petitioner was not complying substantially with participation requirements on dates between May 23, 2001 and August 17, 2001. The regulatory scheme does not require that CMS provide affirmative evidence of continuing noncompliance. Barn Hill Care Center, DAB No. 1848 (2002). The burden is on Petitioner to prove affirmatively, by a preponderance of the evidence, that it came into compliance on a date subsequent to the date it came out of compliance. A.W. Schlesinger Geriatric Center, DAB CR853 (2002); Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); Ebenezer Luther Hall, DAB CR969 (2002).

2. Petitioner failed to prove by a preponderance of the evidence that it had achieved substantial compliance as of June 22, 2001. In general, a revisit survey is needed to establish substantial compliance.

Petitioner argues that it came into compliance on June 22, 2001, and relies on its POC to establish that it come into compliance on that date. Petitioner failed to prove by a preponderance of the evidence that it had achieved substantial compliance as of June 22, 2001 primarily because some, if not all, of the deficiencies involved are of the type that require on-site observation to verify compliance. On-site observation to verify compliance was made by a revisit survey conducted on August 17, 2001. In addition, the in-servicing referred to in Petitioner's POC was not completed by June 22, 2001, the alleged date of compliance, and the POC was not accompanied by credible written evidence that is verifiable without an on-site visit. I discuss the latter two reasons for my decision first and discuss the primary reason at the end of this decision.

a. In-servicing referred to in Petitioner's POC was not completed by June 22, 2001, the alleged date of compliance.

Petitioner was cited to be out of compliance with 42 C.F.R. � 483.13(c)(1) (Tag 224) which provides that:

The facility must develop and implement written policies and procedures that prohibits mistreatment, neglect or abuse of residents and misappropriation of resident property.

As part of Petitioner's POC to correct the deficiency at 42 C.F.R. � 483.13(c)(1) (Tag 224), it alleged that it had reviewed the resident's plan of care and re-in-serviced unit staff and security on the functioning of resident alarm systems and monitoring of operations. CMS Ex. 3. Petitioner further alleged as part of its POC that it had revised its policy on wandering residents and security systems and re-in-serviced staff on the revised policy. Id.

Petitioner relies on an affidavit from Ms. Pappadoulis who is the Director of Professional Services for Petitioner's owner. I do not give great weight to Ms. Pappadoulis's affidavit because I find it self-serving, not supported by documentary evidence in Petitioner's control, and not given subject to the penalty of perjury. The evidence before me is also silent as to Ms. Pappadoulis's qualifications. Although Petitioner's brief claims that Ms. Pappadoulis is a registered nurse, there is no evidence before me as to her experience in direct care and she never states in her affidavit that she is a registered nurse.

As evidence that Petitioner had complied with its POC, Petitioner's witness, Ms. Pappadoulis stated that the unit staff were in-serviced regarding the proper functioning of resident alarm systems and monitoring transmitter bracelets. However, the in-service logs for what is entitled "Adherence to Plan of Care, Residents and Security Systems and Inclusion of Intervention in NAAR," show that the in-servicing continued past June 22, 2001, the date Petitioner alleges it was in compliance with all the deficiencies found during the May 23, 2001 revisit survey. P. Exs. 15, 30. In fact, the evidence shows that 99 staff members were in-serviced between June 23 and June 30, 2001, and at least 34 staff members were in-serviced in July 2001, including at least 23 individuals on Petitioner's staff who were not in-serviced until July 31, 2001, 39 days past the date Petitioner alleged to be in compliance. P. Ex. 15, at 3 - 5, 11 - 12, 13, 14, 16, 20 - 22. A facility's failure to complete in-servicing with respect to care for which it was found deficient is evidence that the facility did not correct the deficiency and achieve substantial compliance. Coquina Center, DAB No. 1860 (2002), at 31.

Petitioner also failed to complete in-servicing with respect to the deficiency found at 42 C.F.R. � 483.20(k)(3)(ii) (Tag 282). At the time of the May 23 revisit survey, Petitioner was found out of compliance with 42 C.F.R. � 483.20(k)(3)(ii), which provides that:

The services rendered or arranged by the facility must be provided by qualified persons in accordance with each resident's written plan of care.

Petitioner was found out of compliance with Tag 282 for failing to provide services in accordance with the plan of care for two residents at the time of the May 23, 2001 revisit survey. As part of Petitioner's POC, it alleged that the nursing staff was re-instructed on the necessity of following the plan of care and ensuring that safety devices called for by a plan of care were in place. Ms. Pappadoulis again cited to the POC and in-service attendance logs to support this allegation. However, as mentioned above, the attendance logs for the in-servicing entitled "Adherence to Plan of Care" did not show complete attendance to this in-service until July 31, 2001. P. Ex. 30 at � 38; P. Exs. 1, 15, and 21.

Further, Petitioner failed to complete in-servicing on following the plan of care with respect to the range of motion deficiency found at 42 C.F.R. � 483.25(e)(2) (Tag 318) ⁽¹⁾, the accident deficiency found at 42 C.F.R. � 483.25(h)(2) (Tag 324), and the deficiency found at 42 C.F.R. � 483.75(f) (Tag 498) that concerns nurse aides failing to demonstrate proficiency for resident care. The in-service attendance logs on adherence to resident's care plans show that the in-service was not completed until July 31, 2001. P. Ex. 1; P. Ex. 15, at 16, 20 - 22; P. Ex. 21; P. Ex. 30, at � 44.

b. The POC was not accompanied by credible written evidence that is verifiable without an on-site visit.

Petitioner failed to submit "written credible evidence" verifiable without an on-site visit that it achieved substantial compliance. Petitioner relies on a combination of testimony, the POC itself, policy statements, and blank forms that particular corrective actions or policies were implemented.

The regulations require that CMS establish substantial compliance by either an on-site visit or by written credible evidence verifiable without an on-site visit. A POC, by itself, does not establish substantial compliance. A "plan of correction constitutes a promise by Petitioner to take the remedial actions described in the plan. But it does not offer any proof that the actions were being effectuated." A.W. Schlesinger, DAB CR853, at 6 (2002).

A plan of correction is evidence of a facility's compliance efforts and it should be accorded the weight that is justified by its contents and the circumstances of its submission. However there is no requirement, either in applicable regulations or in principles of evidence, that these plans be found to be conclusive proof of compliance. The significance and evidentiary weight that attaches to a plan of correction depends on the contents of the plan and the attending circumstances of its submission. A plan of correction is not necessarily dispositive proof of compliance. In and of itself it is not necessarily sufficient to overcome the presumption of continuing noncompliance that is established by survey report findings. CMS is not obligated to accept as true the allegations made in a plan of correction, nor am I required to find the allegations made in a plan of correction to be proof of compliance that is sufficient to overcome a presumption of noncompliance resulting from past survey findings.

Schlesinger, at 4 - 5.

Petitioner attempted to provide "written credible evidence" by submitting blanks forms along with its POC as proof that the actions alleged have been implemented. The submission of blank forms only prove that such forms exist, not that they were used by the staff to show that corrections have been implemented. Completed forms would provide some measure of independent corroboration that the actions alleged have been effectuated and, depending on the circumstances, may rise to the level of credible written evidence. However, Petitioner failed to do this. For example, a blank form entitled "Nursing Unit Rounds" was submitted as part of the evidence that Petitioner had come into compliance with the patient dignity regulation found at 42 C.F.R. � 483.15(a) (Tag 241). P. Ex. 14. A blank form entitled "Assistive/Positioning/Prevention/ Supportive Devices" was submitted as part of the evidence that Petitioner had come into compliance with the regulation requiring that qualified persons must perform services in accordance with a resident's plan of care, found at 42 C.F.R. � 483.20(k)(3) (Tag 282). P. Ex. 12. Blank forms were also submitted as part of the evidence of substantial compliance for deficiencies involving range of motion (Tag 318), and accidents (Tag 324). Id.; P. Ex. 14. Blank forms do not rise to the level of credible written evidence because blank forms do not show that corrections have been implemented. In addition, Petitioner did not submit other documentary proof of compliance such as resident records, or nursing notes.

c. Some, if not all, of the deficiencies involved are of the type that require on-site observation to verify compliance.

It is well settled that the state agency's acceptance of Petitioner's POC does not demonstrate that a facility has achieved substantial compliance. Generally, substantial compliance must be demonstrated by a revisit survey. Cross Creek Health Care Center, DAB No. 1665, at 3 (1998); Barn Hill Care Center, DAB No. 1848, at 14 (2002); Lake City, DAB No. 1658, at 12 - 13 (1998). For example, if Petitioner had been cited for not having a backup generator, and subsequently, provided a receipt for payment and installation of a backup generator, then a resurvey would not be necessary. This is not the case here.

Some, if not all, of the types of deficiencies cited against Petitioner are those that would require verification of compliance by an on-site survey instead of relying on credible written evidence verifiable without an on-site observation. Petitioner was cited to be out of compliance with the regulation found at 42 C.F.R. � 483.25(h)(2) (Tag 324) which provides:

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

This deficiency was found to be at a "G" level. A "G" level deficiency involves actual harm that is not immediate jeopardy.

The DAB has held that CMS could reasonably require a resurvey to establish that a facility has come into substantial compliance in a situation involving inadequate supervision. See Barn Hill, DAB No. 1848 (2002); Lake City, DAB No. 1658 (1998). An appellate panel at the DAB opined that "[t]he regulations . . . provide that a facility's return to substantial compliance must usually be established through a resurvey, and in the situation involving inadequate supervision requiring such a survey appears wise." Asbury Center at Johnson City, DAB No. 1815 (2002), at 20, citing Cross Creek Health Care Center, DAB No. 1665 (1998). The surveyors in this case stated that it would not have been possible to determine that Petitioner came back into compliance with respect to Tag 324 prior to August 17, 2001, because of the need to "observe and review evidence that the facility was sufficiently providing adequate supervision and assistance devices to its residents to prevent accidents." CMS Ex. 8, at � 16; CMS Ex. 7, at � 16. I find the surveyors' professional opinions to be persuasive. I agree that a deficiency involving inadequate supervision requires a survey to establish substantial compliance.

At the May 23, 2001 revisit survey, Petitioner was also found to be out of compliance with 42 C.F.R. � 483.13(c)(1) (Tag 224) concerning developing and implementing written policies and procedures that prohibit mistreatment, neglect or abuse of residents and misappropriation of resident property, previously discussed in Part III.B.2.a. of this decision. Petitioner was found out of compliance with this regulation because "despite facility procedures to prevent elopement the facility was unable to protect [Resident 10] from wandering out of the building." CMS Ex. 3, at 2 (emphasis added). Resident 10 was found to have left the building on three separate occasions between May 5 and May 9, 2001. Id. at 1 - 2. Resident 10 had a Wander Guard bracelet and the Wander Guard bracelet security system had apparently been checked and was functioning during the last elopement on May 9, 2001. Petitioner was found to be out of compliance despite facility procedures already in place. In such a case, the facility can only come into compliance after the implementation of its procedures or the implementation of any revised procedures are evaluated by direct observation during an on-site survey.

Further, I find the surveyor's opinions that it would not have been possible to determine that Petitioner came back into compliance with respect to Tag 224 prior to August 17, 2001, the date of the second revisit survey, to carry great weight. CMS Ex. 7, at � 16; CMS Ex. 8, at � 16. In essence, CMS is arguing that the POC relative to this tag is not self-executing, and that a review of the implementation of that POC is required by an on-site revisit survey. I agree that under these circumstances, this type of deficiency is clearly the kind that would require verification of compliance by an on-site survey.

Petitioner was also found to be out of compliance with the regulation found at 42 C.F.R. � 483.75(f) (Tag 498), which requires that:

The facility must ensure that nurses aides were able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.

Petitioner was cited for noncompliance because four certified nursing assistants (CNAs) were unable to demonstrate proficiency while providing resident care. Based on the surveyors' opinions, CMS argues that it was necessary to conduct an on-site visit to actually "observe and review the evidence that the facility's CNAs demonstrated competency and skills necessary to meet resident's needs." CMS Ex. 7, at 16; CMS Ex. 8, at 14. Since the regulation requires that CNAs demonstrate competency, I agree that observation is necessary to determine if the CNAs were competent in providing care to facility residents.

The surveyors were also of the opinion that they could not verify compliance without an on-site survey as to 42 C.F.R. � 483.13(c)(ii) (Tag 225) concerning investigations of alleged instances of mistreatment, neglect or abuse, and 42 C.F.R. � 483.15(a) (Tag 241) concerning resident dignity and individuality. CMS Exs. 7, 8.

3. Petitioner's claims concerning alleged survey irregularities are irrelevant to the issue before me.

Petitioner urges that my decision should be affected by alleged irregularities in the survey process concerning the timing of the receipt of the Statement of Deficiencies and the timing of the first and second revisit surveys. I have already considered Petitioner's arguments prior to my Ruling of April 18, 2003, when I determined that Petitioner did not establish good cause for an extension of time to file its hearing request. The regulations limit my jurisdiction of the issues that I am allowed to hear and decide. The regulations also provide that alleged irregularities in the survey process do not relieve Petitioner from meeting all the requirements of program participation, and are, therefore, irrelevant to a finding of noncompliance and the length of time of that noncompliance. 42 C.F.R. � 488.318(b). Irregularities in the survey process are irrelevant to the issue before me. Beechwood Sanitarium, DAB No. 1824 (2002); Golden State Manor and Rehabilitation Center, DAB No. 1597 (1996); Manor Care of Largo, Inc., DAB CR746 (2001). It should also be noted that the timing of the revisit survey is solely within the agency's discretion. See Arbor Hospital of Greater Indianapolis, DAB No. 1591 (1996); Homestead of Hugo, DAB CR819 (2001).

IV. Conclusion

CMS is authorized to impose a DPNA based on a facility's failure to comply substantially with a single participation requirement. Northern Montana Care Center, DAB No. 1930 (2004). Petitioner has failed to meet its burden of showing it came back into compliance prior to August 17, 2001. CMS is authorized to impose a DPNA for each day of a period that began on July 1, 2001, and which ran through August 16, 2001, against Petitioner.

Alfonso J. Montano

Administrative Law Judge

1. Petitioner was cited because it failed to timely evaluate a left hand fracture suffered by R3 and subsequently erroneously placed a soft splint on the resident's right hand, instead of the left hand. During the on-site revisit survey of August 17, 2001, the surveyors found another resident without the splint called for in her care plan. However, since the resident refused to wear the splint and her husband did not complain about the absence of the splint, the surveyors felt that it would not be appropriate to continue to cite Petitioner for this deficiency.