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OAH 8-0900-17802-2
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STATE OF MINNESOTA
OFFICE OF ADMINISTRATIVE HEARINGS
FOR THE COMMISSIONER OF HEALTH
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In the Matter of Good Samaritan Care Center of Stillwater |
RECOMMENDED DECISION |
The above matter was the subject of an informal dispute resolution meeting conducted by Administrative Law Judge Eric L. Lipman on March 7, 2007. The meeting concluded on that date.
Marci Martinson, Unit Supervisor, Division of Compliance Monitoring, 1645 Energy Park Drive, Suite 300, St. Paul, MN 55108-2970 represented the Minnesota Department of Health (“the Department”). Mary Cahill also attended the meeting and made comments on behalf of the Department.
Susan Voigt, Voigt, Klegon & Rode, LLC, 2550 University Avenue West, Suite 190 South, St. Paul, MN, 55114 appeared on behalf of Good Samaritan Care Center (“Good Samaritan” or “the facility”). The following persons also attended the meeting and made comments on behalf of the facility: Carolyn Dvorak, Caroline Frascone, Julie Ligdae and Sharon St. Mary.
As detailed in the Memorandum that follows, based upon the documentary exhibits, arguments and applicable case law, the Administrative Law Judge makes the following:
RECOMMENDED DECISION
(a) The Commissioner should further recommend that Tag F-272 be SUSTAINED-IN-PART as to Residents 4 and 14 and set aside as to Resident 1;
(b) The Commissioner should further recommend that Tag F-279 be SUSTAINED; and,
(c) The Commissioner should further recommend that Tag F-314 be SUSTAINED-IN-PART as to Resident 13 and set aside as to Residents 1, 3, 4, 6, and 14.
Dated this 29th day of March, 2007.
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_s/Eric L. Lipman_____________ |
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ERIC L. LIPMAN |
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Administrative Law Judge |
Reported: Taped, 4 tapes
No transcript prepared
NOTICE
Under Minn. Stat. § 144A.10, subdivision 16 (d) (6), this recommended decision is not binding upon the Commissioner of Health. Further, pursuant to Department of Health Information Bulletin 04-07, the Commissioner must mail a final decision to the facility, indicating whether or not the Commissioner accepts or rejects the recommended decision of the Administrative Law Judge, within 10 calendar days of receipt of this recommended decision.
MEMORANDUM
This matter arises out of a survey at Stillwater Good Samaritan Center (“Good Samaritan”) in December of 2006. On January 5, 2007, the Minnesota Department of Health (“MDH”) issued a Statement of Deficiencies designating a series of “F-Tags.” These tags set forth areas in which the Department asserts that Good Samaritan fell below the federal requirements for participation in the Medicare and Medicaid programs. If later sustained, any of these deficiencies could result in the application of sanctions to Good Samaritan.
General Statutory and Regulatory Background
Participation requirements for skilled nursing and other long-term care facilities in the Medicare program are set forth in 42 C.F.R. Part 483, Subpart B. Provisions governing the surveying of long-term care facilities and enforcement of their compliance with participation requirements are in 42 C.F.R. Part 488, Subparts E and F.
Federal Medicare and Medicaid authorities assure compliance with the participation requirements through regular surveys by state agencies. The survey agency reports any “deficiencies” on a standard form called a “Statement of Deficiencies.”[1]
A “deficiency” is a failure to a meet a participation requirement in 42 C.F.R. Part 483.[2] Deficiency findings are organized in the Statement of Deficiencies under alpha-numeric “tags,” with each tag corresponding to a regulatory requirement in Part 483.[3] The facts alleged under each tag may include a number of survey findings, which (if upheld) would support the conclusion that a facility failed to meet the regulatory standards.
A survey agency's findings also include a determination as to the “seriousness” of each deficiency.[4] The seriousness of a deficiency depends upon both its “scope” and its “severity.”[5]
When citing deficiencies, state surveyors use the Centers for Medicare and Medicaid Services (CMS) “Chart of Enforcement Remedies” (otherwise known as the “Scope and Severity Grid” or “the Grid”). The level of deficiency and the enforcement action to be taken is set out on each square of the Grid. Each square on the Grid has a letter designation. A is the least serious, and L is the most serious.[6]
A facility becomes subject to remedial action under the participation agreement when it is not in “substantial compliance” with one or more regulatory standards.[7] A facility is not in substantial compliance with a participation requirement if there is a deficiency that creates at least the “potential for more than minimal harm” to one or more residents.[8]
If a facility is found not to be in “substantial compliance,” CMS may either terminate the facility's provider agreement or allow the facility the opportunity to correct the deficiencies pursuant to a plan of correction.[9] Further, CMS may, based upon the severity of the deficiencies, impose an intermediate remedy, such as a monetary penalty, for each day in which the facility was not in substantial compliance with the terms of the participation agreement.[10]
Lastly, Minnesota Statutes §144A.10, Subdivision 16, establishes a process for independent and informal resolution of disputes between survey agencies and health care providers with a participation agreement. In this request for Independent Informal Dispute Resolution, Good Samaritan submits three F-Tags for review.
Tag F-272 – Failure to Conduct Needed Assessments
A. Regulatory Standards and Surveyor Claims
Under the quality of care regulations, the facility must provide the necessary care and services so that each resident might attain the highest practicable physical, mental, and psychosocial well-being.[11] So as to guide the delivery of services the facility is likewise obliged to conduct initial and periodic assessments of the resident that are “comprehensive, accurate, standardized, and reproducible.”[12]
These comprehensive assessments are to occur at three distinct times. The regulations require that a facility complete a comprehensive assessment of a resident: within 14 days of admission or readmission; not less than once every 12 months thereafter; or when a “significant change” in the resident occurs.[13] “Significant change” has a specialized regulatory definition and is required:
[w]ithin 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. (For purposes of this section, a "significant change" means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by the staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan or both).[14]
Additionally, the regulations require that a "comprehensive assessment" use a resident assessment instrument (RAI) and that the results of the instrument be recorded and reported using the Minimum Data Set (MDS).[15]
B. Residents 4 and 14
As to both Residents 4 and 14, significant changes were noted on their respective Minimum Data Sets, and yet the record does not establish that comprehensive assessments were completed as to these residents within 14 days of those determinations.[16] In the view of the Administrative Law Judge, this point was dispositive of the dispute and should have been the end of the inquiry.
More problematic, however, is that notwithstanding this fairly straight-forward and verifiable claim under the regulations, the hearing and submissions from the parties spiraled into a heated clash over nursing judgment. The exchanges as to the needed treatment for Resident 4 provide a good example. For their part, as to Resident 4, the surveyors complained that the facility did not adequately explore the possibility of employing “intermittent catheterization” (a procedure by which a catheter is periodically inserted and withdrawn, as it is needed)[17] to void this Resident’s bladder.[18] Angry, and a little bewildered, the facility witnesses compellingly testified that Resident 4 was an edemic man whose genitals were extremely tender and swollen[19] – such that the process of periodically inserting and retracting a catheter at intervals throughout the day would have been so painful to the Resident as to border on the monstrous.[20] In the facility’s view, it is simply inappropriate to cite as a deficiency the claimed failure to thoroughly explore a practice that would have tormented a patient in their charge.
Because this Tag should be sustained, in part, on other grounds, the catheterization dispute is not recounted here because it had a substantive impact on the recommendation – plainly, it did not. It is detailed because as the Department and participating facilities search for ways to build mutual understanding during the survey process, and methods of reducing the burden of dispute resolution, this exchange provides an important example. It is evident that disputes which pivot closely around the text of the regulations and the State Operations Manual can be quickly examined by the parties, and regardless of the substantive result of the dispute resolution process, can be a fount for future, shared understandings as to the required practices. By contrast, disputes which devolve to arguments over the best nursing practice in situations that are not clearly provided for in the regulatory text will be difficult and time-consuming for this (or any) process to resolve. Worse still, such disputes may inspire more distrust between the Department and surveyed facilities rather than less.
C. Resident 1
With respect to Resident 1, the surveyors assert that while risk factors were documented “in various locations throughout the record,” the surveyors complained that “an analysis and subsequent summary of all skin risk data could not be found.”[21] As discussed in greater detail below, under Tag 314, the Administrative Law Judge is not aware of any requirement for such “summaries,” and no such requirement has been referenced. Without such a separate requirement, the application of this Tag to Resident 1 is without a sufficient basis.
The Commissioner should recommend that this portion of F-272 be set aside.
Tag F-279 – Comprehensive Care Planning
A. Regulatory Standards and Surveyor Claims
Federal regulations require participating facilities to develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, mental and psychosocial needs as identified in the comprehensive assessment.[22] Further, this plan “must describe . . . [t]he services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under § 483.25.”[23]
B. Resident 12
Following a diagnosis of chronic renal failure, Resident 12 was admitted to Good Samaritan on August 21, 2006.[24] Resident 12’s plan of care was updated on November 20, 2006 so as to further detail his dialysis care needs. The surveyors note, however, that the updated plan did not include important detail as to the input and output of fluids for this resident.[25]
During the survey, the Good Samaritan staff augmented this resident’s care plan to include a series of regimes that would avoid infections at the point of a subclavian catheter.[26] Because these procedures were specific interventions, with measurable goals and approaches, they appear to qualify as “services that are to be furnished to attain or maintain the resident's highest practicable physical well-being” under Part 483.20. This detail should have been part of Resident 12’s care plan before the survey.
The U.S. Health and Human Services Departmental Appeals Board’s decision in Lakeland Continuing Care Center supports this conclusion. In that case, the Board observed:
[T]he legally relevant inquiries should include whether the problems which placed residents at risk for more than minimal harm were the foreseeable consequences of the facility's established practices, and, moreover, whether the facility could have promptly discovered and eliminated the problems even if no compliance survey had been conducted.[27]
In this case it is not clear that the missing anti-infection procedures would have been included on Resident 12’s care plan, or those specific interventions undertaken, without the omission having been highlighted by the surveyors.
The Commissioner should recommend that this Tag be sustained.
Tag F-314 – Pressure Ulcer Treatment and Management
A. Regulatory Standards and Surveyor Claims
As noted above, the quality of care regulations oblige participating facilities to conduct initial and periodic assessments of residents so as to guide the delivery of services.[28]
Specifically with respect to the hazard of pressures sores, the federal quality of care regulations state:
Based on the comprehensive assessment of a resident, the facility must ensure that—
(1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and
(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.[29]
In their Statement of Deficiencies, the surveyors asserted that with respect to Resident 13,[30] the facility violated 42 C.F.R. § 483.20(b)(2)(ii), because it failed to complete a comprehensive assessment when the resident experienced a “significant change.”[31] As to Residents 1, 3, 4, 6 and 14, the Department further contends that the facility did not otherwise complete a “comprehensive skin assessment” so as to provide for “effective ulcer prevention.”[32]
B. Resident 13
As to Resident 13, the F-314 Tag should be sustained. The record makes clear that notwithstanding significant weight loss and a serious fracture,[33] following the quarterly Minimum Data Set assessments on July 7, 2006 and October 6, 2006,[34] no comprehensive assessment was undertaken. In the view of the Administrative Law Judge, this decline in Resident 13’s condition does qualify as a “significant change,” such that Good Samaritan was obliged to undertake a comprehensive re-assessment and to consider changes to the care plan.[35]
C. Residents 1, 3, 4, 6 and 14
As noted above, with respect to Residents 1, 3, 4, 6 and 14, the Department argues that the facility did not otherwise complete a “comprehensive skin assessment” so as to provide for “effective ulcer prevention.”
In the view of the Administrative Law Judge the dispute as to this portion of the F-314 can be segregated into two parts: The parties differ as to the nursing judgment that should follow from certain events and they disagree as to how relevant health records should be compiled.
As to the dispute regarding which interventions should follow specific medical conditions, the Department’s complaint as to Resident 6 is emblematic. The Department states:
The quarterly [Minimum Data Set] dated 9/21/06 identified impaired cognition, extensive assistance of 1 staff for bed mobility, dressing and toileting and the resident frequently incontinent of bowel and bladder. With these risks, the resident should have had a specific individualized turning schedule based on an assessment including an assessment to determine how frequently she should turn and reposition.[36]
While the Department’s view as to the elements of treatment, without doubt, represents a sound response to the risks that were presented; it is not at all clear that this response is the only one that is permitted, or that it is a response which necessarily follows from 42 C.F.R. § 483.25 or the State Operations Manual.
The record as a whole demonstrates that Good Samaritan had a pyramiding and reinforcing set of procedures so as to meet the regulatory standard that residents receive “necessary treatment and services to promote healing, prevent infection and [to] prevent new sores from developing.”[37] As acknowledged by the Department, and by way of example, among the procedures that were employed to treat and care for these residents were: weekly skin assessments, regular use of the Braden Scale, tissue tolerance assessments and thorough wound assessments.[38]
This portion of the dispute between the Department and Good Samaritan is a divergence over nursing judgment. In the view of the Administrative Law Judge, where neither the regulations, nor the State Operations Manual, compel a specific treatment response by Good Samaritan, it is inappropriate for the surveyors to assign a deficiency.
Similarly, reminiscent of the dispute under Tag 272, the surveyors and Good Samaritan clashed again over the compilation of the test results developed by the facility. While acknowledging that caregivers at the facility worked as a multi-disciplinary team, and that risk factors were documented “in various locations throughout the record,” the surveyors complained that “an analysis and subsequent summary of all skin risk data could not be found.”[39] To be sure, the hoped-for summaries might have made the surveyors’ review a little easier, and it might have developed a bit of goodwill between the parties; the Administrative Law Judge is not aware of any requirement for concise summaries of interim assessments. Moreover, no such requirement has been referenced. Without such a separate requirement,[40] the application of this Tag to Residents 1, 3, 4, 6 and 14 is without a sufficient basis.
The Commissioner should recommend that this portion of the Tag be set aside.
E.L.L.
[1] See, 42 C.F.R. § 488.325 (a) (2005); CMS State Operations Manual, Appendix P, Section IV.
[2] See, 42 C.F.R. § 488.301 (2005).
[3] CMS State Operations Manual, Appendix P, Section IV.
[4] See, 42 C.F.R. § 488.404 (2005).
[5] See, Ex. C.
[6] See, Ex. C-4.
[7] See, 42 C.F.R. § 488.400 (2005).
[8] See, 42 C.F.R. § 488.301 (2005).
[9] See, 42 C.F.R. §§ 488.402, 488.406 and 488.412. (2005).
[10] See, 42 C.F.R. §§ 488.406, 488.408 and 488.440 (2005).
[11] See, 42 C.F.R. § 483.25 (2005).
[12] See, 42 C.F.R. §§ 483.20, 483.25 (2005); compare also, Ex. F-1, State Operations Manual, App. P, Tag F 272 (the intent of 42 C.F.R. § 483.20 is to "provide the facility with ongoing assessment information necessary to develop a care plan to provide the appropriate care and services for each resident, and to modify the care plan and care/services based on the resident's status").
[13] See, 42 C.F.R. § 483.20 (b) (2) (2005).
[14] See, 42 C.F.R. § 483.20 (b) (2) (ii) (2005).
[15] See, Ex. F-1 and F-2 State Operations Manual (SOM), App. P.
[16] See, Exs. M-3 through M-7 (Resident 4) and Exs. L-3 through L-13 (Resident 14).
[17] Ex. W-11.
[18] Ex. E-6.
[19] See, e.g., Exs. M-12 through M-17.
[20] See, Testimony of J. Ligdae.
[21] Id., at 13.
[22] See, 42 C.F.R. § 483.20 (k) (2005).
[23] See, 42 C.F.R. § 483.20 (k) (1) (i) (2005).
[24] Ex. E-12.
[25] See, Exs. E-11 and E-12, and “Stillwater Good Samaritan Center, Survey Exit December 7, 2006,” at 25.
[26] See, Ex. T-15.
[27] See, Lakeland Continuing Care Center v. Centers for Medicare & Medicaid, Docket No. C-97-070 (Dep’t App. Bd. 2000) (http://www.hhs.gov/dab/decisions/cr683.html).
[28] See, 42 C.F.R. §§ 483.20, 483.25 (2005); Ex. F-1, State Operations Manual, App. P, Tag F 272.
[29] See, 42 C.F.R. § 483.25 (c) (2005).
[30] Consistent with the protections provided in Minn. Stat §§ 13.05 and 13.384 and the Protective Order in this matter, residents will be referred to by number, as denominated in the Department’s survey, in lieu of the resident’s given name.
[31] See, Exs. I-4, I-5 and I-18.
[32] See, e.g., Ex. E-13 and “Stillwater Good Samaritan Center, Survey Exit December 7, 2006,” at 13.
[33] Exs. I-9, I-18 and I-34.
[34] Exs. I-8 through I-10 and I-4 through I-6.
[35] Compare, e.g., Britthaven of South Louisville v. Centers for Medicare & Medicaid, Docket No. C-01-804 (Dep’t App. Bd. 2003) (http://www.hhs.gov/dab/decisions/CR1053.htm) (substantial weight loss qualifies as a significant change in the resident's condition).
[36] See, “Stillwater Good Samaritan Center, Survey Exit December 7, 2006,” at 13 (emphasis added).
[37] See, 42 C.F.R. § 483.25 (c) (2) (2005).
[38] See, “Stillwater Good Samaritan Center, Survey Exit December 7, 2006,” at 13 - 17.
[39] Id., at 13.
[40] Compare, e.g., Kelsey Memorial Hospital, v. Centers for Medicare & Medicaid, Docket No. C-96-216 (Dep’t App. Bd. 1999) (Petitioner-facility was not in compliance with regulations where required assessment information, while present in the medical file, was not reflected on the Minimum Data Set form) (http://www.hhs.gov/dab/decisions/cr-583.html#N_10_).