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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Pathfinder Healthcare, Inc., |
DATE: Ocotober 7, 2002 |
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Centers for Medicare & Medicaid Services
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Docket No.C-02-094
Decision No. CR958 |
| DECISION | |
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DECISION Uncontested deficiency findings from the July 31, 2001 survey, and the proven violations of 42 C.F.R. � 483.25(i)(2) and 42 C.F.R. � 483.35(h)(2) from the revisit survey in September 2001, provide a basis for a Denial of Payment for New Admissions (DPNA) effective September 7, 2001. All deficiencies were resolved as of the revisit survey of October 2001, which began on October 17, 2001. Accordingly, after October 16, 2001, there was no longer a basis for a continuing DPNA or the proposed termination of Petitioner's provider agreement. Petitioner was in substantial compliance as of October 16, 2001. A DPNA is approved only for the period September 7, 2001 through October 16, 2001. I. Procedural History Petitioner, a non-profit corporation organized under the laws of the State of Arkansas, is a skilled nursing facility (SNF) certified to participate as a provider under Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act (Act) (42 U.S.C. �� 301 - 1397jj). Petitioner was subject to a standard survey by the Arkansas Department of Human Service, Office of Long-Term Care (ADHS-OLTC) which concluded on June 7, 2001, with three revisits on July 31, 2001, September 14, 2001, and October 19, 2001. The parties agree that the six-month survey cycle ran from June 7, 2001 through December 7, 2001. Transcript (Tr.) at 41-43. Petitioner was found not in substantial compliance with various regulatory participation requirements on the June 7th survey and each of the revisits. The Centers for Medicare & Medicaid Services (CMS) notified Petitioner that, due to cited deficiencies, Petitioner would be denied payment for all new Medicare and Medicaid patients after September 7, 2001 and that Petitioner's provider agreement would be terminated effective November 15, 2001, if Petitioner did not achieve a state of substantial compliance. (1) Petitioner requested a hearing by letters dated November 9 and 14, 2001. Petitioner appealed the findings of the July, September, and October revisit surveys. Petitioner's requests for hearing were received at the Civil Remedies Division (CRD), Departmental Appeals Board (DAB) on November 13 and 15, 2001, respectively. The case was assigned to me for hearing and decision on November 27, 2001. On November 14, 2001, Petitioner moved for an expedited hearing, citing as justification the fact that it had been subject to a DPNA since September 7, 2001 and that United States District Judge James Moody granted a temporary restraining order (TRO) on November 13, 2001 that barred termination of Petitioner's provider agreement until such time as it exhausted its administrative appeal rights. (2) CMS did not file an opposition to the motion. I granted Petitioner's motion for expedited hearing and set this case for hearing in my Order of January 2, 2002 A hearing was conducted in Pine Bluff, Arkansas, from February 26 through 28, 2002. Petitioner's exhibits (P. Exs.) admitted and considered in this decision are: P. Exs. 1-29, 31-55, 57-60, 62 and 63, 65 (Tr. at 28), and 66 (Tr. at 473). Petitioner withdrew it exhibits numbered 30 (Tr. at 21) and 56 (Tr. at 23). Petitioner's exhibits 61 and 64 were offered but not admitted on an objection by CMS (Tr. at 25, 27). CMS's exhibits (CMS Exs.) admitted and considered in this decision are: CMS Exs. 1-10, 12-19, 22-28, 30-39, 43, 45, 46, 48, 49, 52 (Tr. at 30), 53 (Tr. at 255), and 54 (Tr. at 473). (3) A 591-page verbatim transcript of the proceedings was prepared and verified by the parties subsequent to the hearing. The parties simultaneously submitted posthearing briefs and responses. On May 17, 2002, CMS moved to strike Petitioner's proposed findings of fact and conclusions of law submitted as attachments to its posthearing brief as they exceeded the page limit I had set for posthearing briefs. Petitioner's posthearing pleadings included: a 30-page posthearing brief (with signatures on page 31); 6-page listing of its exhibits; 10 pages of proposed conclusions of law; 18 pages of proposed findings of fact; and 24-page response brief with one exhibit attached. CMS's posthearing pleadings included: 29-page brief with signatures on page 30; 4-page list of its exhibits; 30-page reply brief with conclusion and signatures on page 31 with exhibits 1 through 3 attached; and document styled "CMS's Request For Affirmance Of Its Determination." CMS's Motion to Strike is denied. At the conclusion of the trial, I clearly advised the parties that they were limited to a 30-page posthearing brief and a 30-page response, a total of 60 pages for their arguments. I advised them that they could incorporate their prehearing brief by reference and that they should attach to their posthearing brief a complete list of their exhibits, proposed findings of fact and conclusions of law. Tr. at 589-590. Petitioner's submissions were consistent with my instructions. Petitioner's findings and conclusions were submitted in a format that I could simply incorporate in large part in my decision if I chose to. Proposed findings and conclusions are not argument, which is the purpose of the posthearing brief and response. CMS's failure to submit separately stated findings and conclusions causes no prejudice to CMS, as both of CMS's briefs are clear and comprehensive in addressing the issues presented by the case and I can clearly discern what CMS suggests in the way of findings and conclusions. CMS's pleading styled as "CMS's Request For Affirmance Of Its Determination" is really argument that I would expect to be included in the posthearing brief or response. Petitioner filed no objection to CMS's additional pleading and it is not stricken. However, counsel are strongly encouraged to comply with page-limits in the future. The record is complete and I have jurisdiction. II. Findings of Fact 1. Petitioner, a non-profit corporation organized under the laws of the State of Arkansas, is a skilled nursing facility (SNF) certified to participate as a provider under Title XVIII (Medicare) and Title XIX (Medicaid) of the Act. 2. Petitioner was subject to a standard survey by the
Arkansas Department of Human Service, Office of Long-Term Care (ADHS-OLTC),
which concluded on June 7, 2001, as well as three revisits on July 31,
2001, September 14, 2001, and October 19, 2001. 3. The six-month survey cycle ran from June 7, 2001 through December 7, 2001. 4. ADHS-OLTC found that Petitioner was not in substantial compliance with various regulatory participation requirements on the June 7th survey and each of the three revisits. 5. CMS notified Petitioner that, due to cited deficiencies, Petitioner would be denied payment for all newly admitted Medicare and Medicaid patients after September 7, 2001 and that Petitioner's provider agreement would be terminated effective November 15, 2001, if Petitioner did not achieve a state of substantial compliance. 6. Petitioner requested a hearing before an administrative law judge (ALJ) regarding deficiencies cited in the July, September, and October 2001 surveys. 7. Regarding the July 2001 revisit survey, Petitioner requested review of only the alleged violation of 42 C.F.R. � 483.10(b)(11) (F Tag 157). Petitioner did not withdraw its request for review of this alleged deficiency but affirmatively elected not to proceed on this deficiency at hearing. 8. CMS withdrew the alleged deficiencies from the July 2001 survey cited as violations of: 42 C.F.R. � 483.25(a)(3); 42 C.F.R. � 483.25(d)(2); 42 C.F.R. � 483.25(e)(2); 42 C.F.R. � 483.25(h)(2); 42 C.F.R. � 483.35(c)(1)-(3); 42 C.F.R. � 483.65(a)(1)-(2); and 42 C.F.R. � 483.70(h)(4). 9. CMS did not present evidence or argument on the deficiency appealed by Petitioner, i.e., 42 C.F.R. � 483.10(b)(11) (F Tag 157). 10. The deficiencies cited on the July 2001 survey, which have not been appealed or withdrawn, including 42 C.F.R. � 483.20(k) (F Tag 279), 42 C.F.R. � 483.25(a)(2) (F Tag 311), 42 C.F.R. � 483.25(i)(2) (F Tag 326), and 42 C.F.R. � 483.35(h)(2) (F Tag 371), have scope and severity levels of D, E, and F.
11. All deficiencies cited on the July 2001 survey were cleared on September 14, 2001 during the revisit survey and they were not cited as a basis for a DPNA after September 13, 2001. 12. Petitioner was cited for two deficiencies in the September 14th Statement of Deficiencies (SOD) and the October notices; a violation of 42 C.F.R. � 483.25(i)(2) (F Tag 326), scope and severity E; and a violation of 42 C.F.R. � 483.35(h)(2) (F Tag 372), scope and severity F.
13. The following findings relate to Resident 2, one of the two examples cited in the September 2001 SOD:
14. The following findings relate to Resident 6, one of the two examples cited in the September 2001 SOD:
15. It is general practice in the industry to document serving Boost to nursing home residents. 16. CMS cited the violation of 42 C.F.R. � 483.25(i)(2) at a scope and severity level of E, which translates to a pattern of noncompliance with "no actual harm with potential for more than minimal harm that is not immediate jeopardy," based on more than two examples. 17. During the September 2001 survey, a surveyor found seven scoops in a drawer with dried food on them; seven pans under the steam table with food on them; and five plates on a utility cart with dried food on them; five pounds of cheese slices were partially open exposing the cheese to freezer burn; three loose cheese slices were dried and on top of another bag of cheese; and three cartons of ice cream were torn exposing the ice cream to freezer burn. In addition, the surveyor saw two 10-pound logs of ground beef in a sink thawing at room temperature which was later cooked; 10 pounds of ham was seen on the counter near the sink thawing at room temperature for nearly three hours; and 16 tray covers were dried by an employee with a cloth towel rather than allowing them to air dry. 18. The multiple violations of 42 C.F.R. � 483.35(h)(2) were widespread, with no actual harm but potential for more than minimal harm that is not immediate jeopardy, based on multiple examples. 19. On October 17, 18, and 19, 2001, ADHS-OLTC conducted a revisit survey of Petitioner's facility that resulted in a Quick Report dated October 19, 2001, in which it is alleged that Petitioner violated 42 C.F.R. �� 483.13(b) (abuse) (F Tag 223), 483.13(c)(1)(ii) (staff treatment of residents) (F Tag 225), and 483.13(c)(1)(i) (staff treatment of residents) (F Tag 226) 20. The deficiencies cited on the September 2001 survey were not present on October 17, 2001, the beginning of the October 2001 survey. 21. CMS alleges multiple violations of 42 C.F.R. � 483.13 based on surveyor findings on the October 2001 survey: (1) some CNA's cussed or cursed residents and handled residents roughly (Examples 1, 2, 3); (2) the facility failed to report the incidents of cussing and rough handling (Examples 4, 5); and (3) the facility failed to do background checks on some employees before hiring (Example 6). 22. Petitioner had developed the policies required by 42 C.F.R. � 483.13(c), which include policies prohibiting maltreatment, neglect, abuse, and misappropriation; policies regarding reporting the specified conduct; and policies regarding hiring. 23. Petitioner documented checking the State nurse's aide registry for some employees, but not all. 24. At the time of the October 2001 survey, Petitioner employed no individuals prohibited by 42 C.F.R. � 483.13(c)(1)(ii). III. Conclusions of Law 1. Petitioner's request for hearing was timely filed. 2. I have jurisdiction of this case. 3. The deficiencies cited on the July 2001 survey which have not been appealed or withdrawn, including 42 C.F.R. � 483.20(k) (F Tag 279), 42 C.F.R. � 483.25(a)(2) (F Tag 311), 42 C.F.R. � 483.25(i)(2) (F Tag 326), and 42 C.F.R. � 483.35(h)(2) (F Tag 371), stand as the final decision of the Secretary. 4. CMS did not make a prima facie showing of a violation of 42 C.F.R. 483.10(b)(11) (F Tag 157). 5. DPNA is reasonable based on the uncontested deficiencies from the July 2001 survey with scope and severity levels D, E, and F. 6. DPNA was proper effective September 7, 2001 based upon the deficiencies remaining from the July 2001 survey. 7. On September 14, 2001 the deficiencies from the July 2001 survey were cleared and those deficiencies did not provide a basis for a DPNA after September 13, 2001. 8. 42 C.F.R. � 483.25 requires a facility to "provide the necessary care and services" to ensure each resident attains or maintains the "highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care" which is developed by an interdisciplinary team including a resident's doctor and the facility staff in accordance with 42 C.F.R. � 483.20 and includes the requirement to provide a "therapeutic diet when there is a nutritional problem." 42 C.F.R. � 483.25(i)(2) . 9. CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.25(i)(2) by showing: (a) a doctor's order required and the plan of care provided that each resident was to receive a can of Boost with meals three times per day; (b) the residents did not receive Boost as ordered; (c) the doctor's order and the plan of care give rise to the inference that there was a nutritional problem or the potential for such problems with a potential for more than minimal harm; and, (d) because deficiencies have been shown with respect to more than one resident on one occasion, there is also an inference that there is a pattern of noncompliance. 10. There is no authority that requires CMS to show actual harm to residents in the form of weight loss or otherwise to establish a violation of 42 C.F.R. � 483.25(i)(2). 11. Scope and severity level of E is an appropriate level based on the evidence proving the two violations of 42 C.F.R. � 483.25(i)(2) cited 12. Petitioner did not rebut the prima facie case of a violation of 42 C.F.R. � 483.25(i)(2) or establish an affirmative defense by a preponderance of the evidence. 13. The opinion of Petitioner's expert witness, Eric Glen Peppers, R.N., is not credible to the extent and for the reasons discussed hereafter. 14. The opinions of the doctors of Residents 2 and 6 are not credible for the reasons discussed hereafter. 15. CMS made a prima facie showing of a violation of 42 C.F.R. � 483.35(h)(2) based on the observed conditions recited in Finding of Fact No. 17. 16. CMS is not required to show that any resident became ill to make a prima facie showing of a violation of 42 C.F.R. � 483.35(h)(2). 17. Multiple violations of 42 C.F.R. � 483.35(h)(2) show deficiencies are widespread. 18. The unrebutted evidence shows that there is a potential for more than minimal harm due to the violations of 42 C.F.R. � 483.35(h)(2). 19. Petitioner failed to rebut CMS's prima facie case of a violation of 42 C.F.R. � 483.35(h)(2), and Petitioner failed to establish any affirmative defense. 20. Petitioner violated 42 C.F.R. � 483.35(h)(2) (F Tag 371) at a scope and severity level F. Pursuant to 42 C.F.R. � 488.408(d), CMS has authority to impose category 2 remedies in this case, including a DPNA. The cited deficiencies provide a basis for the continuing DPNA and the DPNA is a reasonable remedy. 21. The October 17 through 19, 2001 revisit survey found that deficiencies cited on the September 14, 2001 survey had been corrected or cleared. 22. Petitioner has not presented credible evidence that the deficiencies from the September 2001 survey were corrected before October 16, 2001. 23. There was a basis for a DPNA from September 7, 2001 through October 16, 2001 based on the July and September 2001 surveys. 24. CMS failed to make a prima facie case that there was any incident of verbal or physical abuse as alleged in the October 19, 2001 survey. 25. Petitioner had the policies required by 42 C.F.R. � 483.13(c). 26. Abuse, within the meaning of the regulations, is the willful infliction of injury, unreasonable confinement, intimidation, or punishment; with resulting physical harm, pain, or mental anguish. 42 C.F.R. � 483.301. 27. "Cursing" and "rough handling," are not conduct specifically prohibited by the Act or the regulations, but both cursing and rough handling are prohibited if they constitute verbal or physical abuse. 28. CMS failed to show that conduct alleged in the October 2001 survey to be cursing and rough handling was "willful" for the infliction of injury, unreasonable confinement, intimidation, or punishment. 29. CMS failed to show that the conduct alleged to be cursing and rough handling caused harm. 30. The opinion of CMS's expert, Louis Burgio, Ph.D., is not credible for the reasons discussed hereafter. 31. CMS failed to show a prima facie case of abuse in violation of 42 C.F.R. �� 483.13(b) or (c)(1)(i), based on the October 2001 survey. 32. Pursuant to section 1819(g)(1)(C) of the Act and 42 C.F.R. �� 483.13(c)(2)-(4), a facility has a duty to investigate and document such investigation when there is an allegation that a reasonable person would recognize as an allegation of abuse and the facility knows or should know that there is such an allegation. If upon its preliminary investigation the facility learns that staff is implicated in an alleged violation of a resident's rights, the facility must conduct a through investigation, document the investigation and report within five working days of the incident as required by 42 C.F.R. � 483.13(c)(4), and take appropriate corrective action if the allegation is verified. 33. Pursuant to 42 C.F.R. �� 483.13(c)(2) and (4), all allegations of violations of resident rights involving mistreatment, neglect, abuse, and misappropriation must be reported to the Administrator and investigated; and investigations where staff is implicated must be reported within five working days of the alleged incident to officials outside the facility, including the State survey agency, in accordance with the procedures established by State law. 34. 42 C.F.R. � 483.13(c) does not conflict with reporting requirements established by State law.35. CMS made a prima facie showing of a violation of 42 C.F.R. � 483.13(c) by showing that there were allegations of cursing and rough handling that had not been investigated prior to the October 2001 survey; with the inference being that staff (who were trained in the facility abuse reporting policy) reported, and the facility thus knew of, the allegations but failed to act.\ 36. Petitioner established the defense of impossibility by a preponderance of the evidence by showing that the Administrator neither knew nor should have known of the allegations of cursing and rough handling prior to the October 2001 survey. 37. CMS's allegations of violation of 42 C.F.R. �� 483.13(c)(2)-(4), for failure to implement the policy required by 42 C.F.R. � 483.13(c) or to investigate and report, are unfounded and provide no basis for a DPNA or termination. 38. 42 C.F.R. � 483.13(c)(1)(ii) prohibits a facility from employing an individual who has been found guilty by a court of abusing, neglecting, or mistreating residents, or who has a finding entered in the State nurse aide registry concerning abuse, neglect, mistreatment of residents, or misappropriation of their property. 39. There is no regulatory requirement that a facility document that the State nurse's aide registry was checked prior to employing an individual. 40. Petitioner's policy does not require that facility staff document that the State nurse's aide registry was checked prior to the facility hiring an individual. 41. CMS has failed to make a prima facie showing that Petitioner violated the Act, regulations, or its own policy by failing to document that the State nurse's aide registry was checked prior to hiring all employees. 42. The allegations
of the October 2001 survey are unfounded and there is no basis for a continuing
DPNA after October 16, 2001 or the proposed termination. IV. Analysis
The Act sets forth requirements for long-term care facilities, both skilled nursing facilities (SNF) and nursing facilities (NF), participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819, 1919. The Secretary's regulations governing SNF and NF participation in the Medicare program are found at 42 C.F.R. Part 483. A SNF or NF must maintain substantial compliance with program requirements to participate in the Medicare and Medicaid programs. If the State or CMS finds deficiencies in the facility's operation during a survey of the facility, the deficiencies noted must pose no greater risk to resident health or safety than the "potential for causing minimal harm" or the facility will be found not in substantial compliance and a certificate of noncompliance will issue. 42 C.F.R. �� 488.301, 488.330. 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 section 1819(h) of the Act and 42 C.F.R.� 488.406. The purpose of the authorized remedies is to "ensure prompt compliance with program requirements." 42 C.F.R. � 488.402(a). Remedies are applied on the basis of the scope and severity of the noncompliance found during surveys. 42 C.F.R.� 488.402(b). The factors to be considered by CMS, when selecting remedies are set forth at 42 C.F.R. � 488.404. A nursing facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e), 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing remedies. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the civil money penalty (CMP) CMS could collect or impact upon the facility's nurse's aide training program. 42 C.F.R. � 498.3(b)(14). In this case, the State agency cited deficiencies at Petitioner's facility during the June 2001 standard survey, and on each revisit in July, September and October 2001. Petitioner did not appeal the deficiencies from the June 2001 survey. Petitioner has elected not to pursue its appeal of the deficiencies cited in the July survey, and for reasons discussed hereafter, there is no need to set forth the cited deficiencies in detail here. Petitioner does contest the deficiency findings from the September 14, 2001 and the October 19, 2001 revisit surveys. The deficiencies cited by the State survey agency allegedly constitute violations of the following regulatory provisions:
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CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999). Black's Law Dictionary 825 (6th ed. 1991) provides several definitions of "prima facie case," one of which is sufficient:
An appellate panel of the Departmental Appeals Board (Board) defined the requirements for a prima facie case in its decision in Hillman, at 8:
If a provider appeals a termination decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation, or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions; and (3) show how the deficiencies it found amount to noncompliance which warrant an enforcement remedy.
Petitioner challenged both the July 31, 2001 survey
(6) and the September 14, 2001 survey in its request for hearing
of November 9, 2001. The July 31, 2001 SOD listed 12 violations at scope
and severity levels D, E, and F: 42 C.F.R. � 483.10(b)(11) (F Tag 157);
42 C.F.R. � 483.20(k) (F
Tag 279); 42 C.F.R. � 483.25(a)(2)
(F Tag 311); 42 C.F.R. �
483.25(a)(3) (F Tag 312); 42 C.F.R.
� 483.25(d)(2) (F Tag 316); 42 C.F.R.� 483.25(e)(2) (F Tag 318); 42 C.F.R.
� 483.25(h)(2) (F Tag 324); 42 C.F.R. � 483.25(i)(2) (F Tag 326); 42 C.F.R.
� 483.25(c)(1)-(3) (F Tag 363); 42 C.F.R. � 483.35(h)(2) (F Tag 371);
42 C.F.R. � 483.65(a)(1)-(3) (F Tag 441); and 42 C.F.R. � 483.70(h)(4)
(F Tag 469). In its November 9, 2001 request for hearing, Petitioner
requested review only as to the deficiency cited in the July 31st
survey as a violation of 42 C.F.R. � 483.10(b)(11) (F Tag 157). On February 22, 2002, CMS filed a motion for summary affirmance of the deficiencies cited on the July 31st survey. CMS attached a letter to its motion that indicated that Petitioner was not appealing the "non-immediate jeopardy findings from the July 31, 2001 survey" and that neither party would be presenting evidence on the July 2001 survey. At the hearing, counsel for Petitioner stated that Petitioner was not appealing the survey of July 31st, but that Petitioner was not withdrawing the request for hearing as to that deficiency. Petitioner also advised that Petitioner does not agree with the findings of the July 31st survey and that Petitioner stands by its denial of the deficiency cited as a violation of 42 C.F.R. � 483.10(b)(11) (F Tag 157) with a scope and severity level of D. Tr. at 10-11. In its prehearing brief, CMS withdrew the deficiency citations from the July 2001 survey alleged as violations of 42 C.F.R. � 483.25(a)(3), 42 C.F.R. � 483.25(d)(2), 42 C.F.R. � 483.25(e)(2), 42 C.F.R. � 483.25(h)(2), 42 C.F.R. � 483.35(c)(1)-(3), 42 C.F.R. � 483.65(a)(1)-(2), and 42 C.F.R. � 483.70(h)(4). CMS Prehearing Brief (CMS Br.), at 4, fn.2. In its posthearing brief CMS discussed only the deficiencies from the July 31, 2001 survey cited as violations of 42 C.F.R. � 483.20(k) (F Tag 279), 42 C.F.R. � 483.25(a)(2) (F Tag 311), 42 C.F.R. � 483.25(i)(2) (F Tag 326), and 42 C.F.R. � 483.35(h)(2) (F Tag 371). CMS Post Brief (CMS Post Br.), at 4-6. CMS also noted in its brief that it withdrew, at hearing, all exhibits except those related to the deficiencies discussed in its brief. CMS Post Br., at 4, fn.1. Petitioner points out in its posthearing response brief that it stated in its prehearing brief that it was not pursuing an appeal of any of the findings of the July 31, 2001 survey. CMS admitted some exhibits related to the July 31, 2001 survey but neither party presented any testimony at hearing regarding the deficiencies cited in the July 31st SOD. Petitioner was cited for 12 deficiencies in the July 31st SOD, with scope and severity levels of D, E, and F. The CMS notice of deficiencies dated September 10, 2001, listed the 12 deficiencies from the July 31st SOD and specified that if the substantial compliance was not achieved by the next revisit, Petitioner's Medicare agreement would be terminated as of November 7, 2001. CMS imposed a DPNA effective September 7, 2001, and specified that the remedy would continue, until the facility achieved substantial compliance or its provider agreement was terminated. CMS Ex. 31. There can be no doubt that the DPNA was imposed based upon the deficiencies cited in the July 31st SOD. Petitioner only challenged the one deficiency cited as F Tag 157 in its request for hearing dated November 9, 2001. Petitioner has affirmatively stated that it no longer seeks review of that deficiency finding, but Petitioner declined to affirmatively waive or withdraw its request for review as to that deficiency. Petitioner further stated that it continued to deny the validity of the cited deficiency. CMS withdrew its evidence as to all cited deficiencies except the four listed above, and F Tag 157 is not one of the four that remains. Because Petitioner did not affirmatively withdraw its appeal and waive review as to F Tag 157, but continued to dispute the deficiency, I must rule. CMS's withdrawal of its evidence and failure to brief the deficiency cited as F Tag 157 causes me to rule that CMS did not make a prima facie case on that deficiency. There remain four deficiencies from the July 31, 2001 survey that were uncontested by Petitioner: 42 C.F.R. � 483.20(k) (F Tag 279); 42 C.F.R. � 483.25(a)(2) (F Tag 311); 42 C.F.R. � 483.25(i)(2) (F Tag 326); and 42 C.F.R. � 483.35(h)(2) (F Tag 371). Because these citations were not challenged, they stand as the final decision of the Secretary. These deficiencies are cited as scope and severity levels D, E, and F. The CMS allegation that these deficiencies provided an adequate basis the imposition of the remedy of a DPNA beginning September 7, 2001 is not challenged before me. Even if Petitioner specifically challenged the reasonableness of a DPNA in light of the uncontested deficiencies, the scope and severity cited by CMS is sufficient to authorize a DPNA (7) and I conclude the DPNA is reasonable. On September 14,
2001, Petitioner was subject to another revisit by ADHS-OLTC. The results
of the survey are recorded in the SOD dated September 14, 2001. CMS Ex.
4. CMS sent notices to Petitioner dated October 3 and 5, 2001, continuing
the DPNA previously imposed and setting the termination date as December
7, 2001 if substantial compliance was not achieved. Comparison of the
July 31st SOD (CMS Ex. 32) and the September 14th
SOD (CMS Ex. 4) reveals that none of the deficiencies cited in the July
31st SOD are cited again in the September 14th SOD.
(8) The parties agree that as a matter of practice, when a deficiency
is not cited on a subsequent revisit, then the deficiency has been "cleared"
or resolved, but CMS provides no separate notice to that effect. Thus,
I conclude that all deficiencies cited on the July 31st survey
were cleared by the September 14th survey, and none of those
deficiencies provided a basis for a continuing DPNA or termination
as of that date. Accordingly, I conclude that the remaining citations
of deficiencies from the July 31st SOD proved a basis for a
DPNA from September 7 through September 13, 2001, and I conclude that
the DPNA was reasonable for that period. After the September 14th revisit the deficiencies cited on the July 31st survey are not the grounds cited by CMS as a basis for its enforcement action. See CMS Exs. 2, 3. Petitioner disputes the findings of deficiencies from both the September 14th survey and the final survey of October 19, 2001.
Petitioner was cited
for two deficiencies in the September 14th SOD and the October
notices, violations of 42 C.F.R. �� 483.25(i)(2) and 483.35(h)(2).
42 C.F.R. � 483.25 requires a facility to "provide the necessary care and services" to ensure each resident attains or maintains the "highest practicable physical, mental, and psycho social well-being, in accordance with the comprehensive assessment and plan of care." The comprehensive assessment and plan of care is developed by an interdisciplinary team including a resident's doctor and the facility staff in accordance with 42 C.F.R. � 483.20. The comprehensive plan of care establishes the standards and requirements for care of each individual resident. 42 C.F.R. � 483.20(k). Section 483.25(i)(2), which was allegedly violated in this case, requires that a facility ensure a resident receives a "therapeutic diet when there is a nutritional problem." The existence of the "nutritional problem" should be identified in the comprehensive assessment and plan of care and the therapeutic diet should also be specified in the plan of care and related doctors orders. (10) . The State agency cites three examples as showing the existence of the violation. CMS chose to proceed on only examples 1 and 2 at the hearing. CMS Ex. 4. Example 1 relates to Resident 2. CMS alleges that Resident 2 had a doctor's order, dated May 28, 2001, for a can of Boost (a liquid dietary supplement (Tr. at 55)) with meal three times per day. A care plan dated August 21, 2001, identifies Resident 2 as at risk for poor nutritional status and specifies a can of Boost with meals three times per day. The surveyor observed on September 14, 2001, that Resident 2 did not receive a can of Boost at breakfast. Tr. at 56; CMS Ex. 4, at 1-2. CMS produced records related to Resident 2, including progress notes, doctor's order, and plan of care, all of which show Resident 2 was to receive a can of Boost three times per day with meals. CMS Ex. 9, at 8, 9, 22, 26. Example 2 involves Resident 6. Resident 6 also had a doctor's order, dated May 8, 2001, that specified a can of Boost three times per day with meals. The order for Boost was recorded on Resident 6's Medication Administration Record (MAR) but the September 2001 MAR did not show that Boost was offered or given to Resident 6. Similarly, the Food Intake Record for Resident 6 did not show that Resident 6 was offered or consumed Boost. The surveyor observed that Resident 6 was not offered or served Boost at lunch or dinner on September 13, 2001 or at breakfast on September 14, 2001. Tr. at 74-86; CMS Ex. 4, at 2-3. CMS produced records related to Resident 6, including a doctor's and dietician's orders that show Resident 6 was to receive one can of Boost three times per day with meals. CMS Ex. 10, at 28, 31, 38. Petitioner's Plan of Correction, dated October 5, 2001, is set forth in the right column of the September 14th SOD at CMS Ex. 4. Petitioner responds, regarding Resident 2, that he "received his portion of Boost later in the day." Regarding Resident 6, Petitioner asserts that the resident's doctor discontinued his order for Boost on September 14, 2001 and that there was no harm to the resident in not receiving Boost as he ate most of his meals. Petitioner also argues that Residents 2 and 6 consume 3000 calories or more per day and neither experienced any weight loss. Petitioner points out that on October 3, 2001, the resident's doctor changed orders from Boost three times per day with meals to Epulor three times per day with medications. CMS Ex. 4, at 1-2. Petitioner elicited testimony from Eric Glen Peppers at the hearing. Tr. at 474-490. Mr. Peppers is a registered nurse with a certificate in gerontology and experience as a director of nursing and nurse consultant for long-term care facilities. Although Mr. Peppers never worked at Petitioner's facility, he reviewed records related to Residents 2 and 6 and the September 14th SOD. Mr. Peppers opined that the facts alleged by CMS did not constitute a violation of Tag 326 related to therapeutic diet and that the two residents were not at risk for weight loss. He acknowledged that both residents had a doctor's order for Boost three times per day with meals; however, the documents do not reflect that Boost was served at the times CMS alleges it was not. Mr. Peppers testified that it is general practice in the industry to document serving Boost to nursing home residents. Tr. at 490. Petitioner does not dispute the surveyor's observations or deny that Residents 2 and 6 did not receive their Boost as alleged. Rather, Petitioner defends on the basis that neither example showed a potential for more than minimal harm, and Petitioner was not out of substantial compliance for this reason. Petitioner's Prehearing Brief (P. Br.), at 10-11. Petitioner asserts in its posthearing brief that CMS failed to meet its burden of showing that either Resident 2 or 6 was at risk for more than minimal harm by the "omission to give Boost on . . . two or three occasions." Petitioner's Posthearing Brief (P. Post Br.), at 1-3. Petitioner is in error in its assertion that CMS failed to meet its burden. Pursuant to the DAB decision in Hillman, CMS must establish a prima facie case, but then the burden of proof and persuasion shifts to Petitioner who must negate the prima facie case or show its affirmative defense by a preponderance of the evidence. 42 C.F.R. � 483.25 provides that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, . . . well-being, in accordance with the comprehensive assessment and plan of care." The regulation further provides that the "facility must ensure that a resident . . . receives a therapeutic diet when there is a nutritional problem." 42 C.F.R. � 483.25(i)(2). CMS has made a prima facie case by showing that (1) a doctor's order required, and the plan of care provided, that each resident was to receive a can of Boost with meals three times per day; (2) the residents did not receive Boost as ordered; (3) the doctor's order and the plan of care give rise to the inference that there was a nutritional problem or the potential for such problems with a potential for more than minimal harm; and (4) because deficiencies have been shown with respect to more than one resident on more than one occasion, there is also an inference that there is a pattern of noncompliance. Contrary to Petitioner's assertions, I find no authority that CMS need show actual harm to the residents in the form of weight loss or otherwise. CMS cited this deficiency at a scope and severity level of E which translates to a pattern of noncompliance with "no actual harm with potential for more than minimal harm that is not immediate jeopardy." SOM, section 7400. The fact that CMS has proceeded on only two examples at hearing does not cause me to find that any lesser scope and severity level is appropriate. CMS made its prima facie showing and the burden shifted to Petitioner. Petitioner failed in its burden. Petitioner did not show that either Resident received the ordered Boost at another time. Petitioner did not show that its failure to provide Boost on the occasions witnessed by the surveyors were simply aberrations. Petitioner did not show that there was a doctor's order modifying the requirement to provide Boost at meals, until after the survey. Petitioner made no showing that it should be excused, for any reason, for failure to comply with the doctor's orders or the plan of care for Residents 2 and 6. 42 C.F.R. � 483.25 is explicit; a facility must provide for each resident's needs in accordance with the "comprehensive assessment and plan of care." The resident's doctor's orders are a critical component of the resident's comprehensive assessment and plan of care. 42 C.F.R. � 483.20. Compliance with the doctor's orders and plan of care is what is required by the regulations. If staff believes a doctor's order or the plan of care is in error or unnecessary, the regulation contemplates that Petitioner will address that matter with the doctor and obtain a change. The regulation does not distinguish between prescription and nonprescription therapies. 42 C.F.R. � 483.25. Petitioner has also failed to negate the inference that the doctor ordered Boost because it was medically necessary, and the failure to comply with that order had the potential for more than minimal harm. (11) While I find Petitioner's witness Mr. Peppers was credible in his testimony, I will not find that his opinion is entitled to more weight than that of the residents' doctors who ordered administration of Boost. Given that Boost was not provided as ordered for two residents on more than one occasion, Petitioner has also not rebutted the inference that there is a pattern of noncompliance. Petitioner provided
a letter on its letterhead dated October 12, 2001, and signed by Resident
2's doctor, which has been admitted as P. Ex. 34. Resident 2's doctor
disagrees with the survey conclusion that there could have been harm to
Resident 2 by not receiving the supplement as ordered. The doctor's opinion
was based on his belief that Food Intake logs showed Resident 2 received
the Boost later in the day, but the evidence was in contradiction with
the doctor's expressed belief. In fact, Resident 2's Food Intake Record
does not reflect any snacks were served the resident during the period
of April 2001 through September 23, 2001, except for a morning snack on
September 12, 2001 when the resident was served no lunch. CMS Ex. 9, at
32. Thus, the doctor's opinion is not credible, as his opinion was based
upon incorrect or incomplete information that is inconsistent with the
evidence of record. I also note that, despite his opinion, the doctor
did not withdraw or change his order for Boost. Petitioner has also submitted a letter from Resident 6's doctor dated October 22, 2001, which has been admitted as P. Ex. 39. Resident 6's doctor advises that on review of Resident 6's situation at the time of the survey, she concluded that the supplement was not necessary and she discontinued her order for supplement on September 14, 2001. P. Ex. 38. I conclude that the doctor's statement is credible, but I do not accept that the post facto review by Resident 6's doctor relieved Petitioner of its regulatory duty to comply with the doctor's order and plan of care in effect at the time of the survey. I conclude that Petitioner was properly cited by the State agency on the September 14th survey for a violation of 42 C.F.R. � 483.25(i)(2) (F Tag 326) with a scope and severity level E. Pursuant to 42 C.F.R. � 488.408(d), CMS has authority to impose category 2 remedies in this case, including a DPNA. The cited deficiency provides a basis for a DPNA and the DPNA is a reasonable remedy.
The State agency cited four examples showing this violation. Example 1 involved the surveyor finding seven scoops in a drawer with dried food on them; seven pans under the steam table with food on them; and five plates on a utility cart with dried food on them. Example 1 also cites that five pounds of cheese slices were partially open, exposing the cheese to freezer burn; that three loose cheese slices were dried and on top of another bag of cheese; and that three cartons of ice cream were torn exposing the ice cream to freezer burn. Example 2 involves two 10-pound logs of ground beef the surveyor saw in a sink thawing at room temperature which was later cooked. Example 3 alleges that 10 pounds of ham was seen on the counter near the sink thawing at room temperature for nearly three hours. Example 4 states that 16 tray covers were dried by an employee with a cloth towel rather than allowing them to air dry. CMS Ex. 4, at 4-5. The State surveyor who made the observations set forth in the SOD, Ms. Oby Okafor, appeared and testified at the hearing regarding this deficiency. Tr. at 60-65, 67-71. Her testimony was consistent with the observations reported in the September 14th SOD. Ms. Okafor also stated the unrebutted opinion that the conditions she observed were unsanitary and created the risk for food poisoning or other food-borne illness. Petitioner's plan of correction, dated October 5, 2001, set forth in the right column of the September 14th SOD, does not deny the surveyor's observations. Rather, the plan of correction detailed the corrective action Petitioner had taken as of October 5, 2001 or planned thereafter. Petitioner does not attempt to rebut the government's evidence, but argues that the uncontested facts are insufficient to meet CMS's burden to make a prima facie showing of a violation. P. Post Br., at 3-4; Petitioner's Response Brief (P. Response), at 5-6. Petitioner is in error in asserting that CMS failed to make a prima facie showing. 42 C.F.R. � 483.35(h)(2) (sanitary conditions) provides that the facility must store, prepare, distribute, and serve food under sanitary conditions. "Sanitary" is given its common meaning absent a specific definition in the regulation, i.e, in a clean and healthy condition. Webster's New World Dictionary (2d ed. 1979). In this case regarding F Tag 372, CMS presented the testimony of a qualified observer who personally observed conditions in the food preparation and serving area of Petitioner's facility. The conditions observed involved cooking and serving utensils and vessels contaminated by dried food. The conditions observed included food not properly wrapped for cold storage, food subsequently destroyed by Petitioner's staff. The conditions observed also included meat being prepared (thawing) improperly and in a condition that, the unrebutted testimony establishes, could lead to contamination. The undisputed testimony regarding the conditions gives rise to an inference that the conditions were unsanitary. The regulation does not require, as Petitioner suggests, that residents must actually become ill for a violation of the regulation to exist. Thus, I find that CMS made prima facie showing, i.e., absent evidence to the contrary it is reasonable to conclude that an unsanitary condition existed in the Petitioner's food service area and that more than a minimal chance for harm to the resident's existed. A pattern existed in that multiple areas of the food service facility were found unsanitary. Pursuant to Hillman, once CMS has made a prima facie case the burden shifts to Petitioner to negate the prima facie case and/or prove its affirmative defense by a preponderance of the evidence. Petitioner actually presented no evidence in its defense, but elected to rely upon the theory that CMS failed to make a prima facie case. Petitioner did not call any of its food service staff to testify. Petitioner did not offer any expert opinions regarding sanitation. Petitioner did not show that there was no contamination. Petitioner did not present evidence that no resident became ill on September 14 or 15, 2001, due to a host of possible food-borne illnesses. Petitioner did not show that there was no potential for more than minimal harm. I conclude that Petitioner was properly cited by the State agency on the September 14th survey for a violation of 42 C.F.R. � 483.35(h)(2) (F Tag 371) cited at a scope and severity level F for widespread deficiencies with the potential for more than minimal harm. Pursuant to 42 C.F.R. � 488.408(d), CMS has authority to impose category 2 remedies in this case, including a DPNA. The cited deficiencies provide a basis for the continuing DPNA and the DPNA is a reasonable remedy.
On October 17, 18, and 19, 2001, ADHS-OLTC conducted a revisit survey of Petitioner's facility. The revisit resulted in a Quick Report dated October 19, 2001, in which it is alleged that Petitioner violated 42 C.F.R. �� 483.13(b) (abuse) (F Tag 223), 483.13(c)(1)(ii) (staff treatment of residents) (F Tag 225), and 483.13(c)(1)(i) (staff treatment of residents) (F Tag 226). CMS Ex. 16. The CMS notice of deficiency dated October 31, 2001, cites the deficiencies alleged in the October 19th Quick Report. The October 31st notice also advised Petitioner that the DPNA noticed in the September 10th notice and effective September 7, 2001 continued and that the new termination date was November 15, 2001. CMS Ex. 3. None of the deficiencies previously included on the July and September SODs are alleged in the October 19th Quick Report or the October 31st notice, indicating that those previously cited deficiencies were no longer present. The fact that the deficiencies from the July and September SODs are not cited also leads me to conclude that as of October 17th, the first day of the October 2001 revisit survey, the previously cited deficiencies no longer provided a basis for a continuing DPNA or the proposed termination. Teresa Bennett, Health Insurance Specialist with CMS, reviewed the survey in this case and testified that termination was based on the October survey, not the September survey. Tr. at 375. She also testified that the tags from the September 14, 2001 survey were cleared at the beginning of the October revisit. Tr. at 376. Thus, unless the deficiencies cited in the October 19th Quick Report are founded, there is no basis for a continuing DPNA after October 16, 2001 (the day before the October 2001 revisit survey began), or the proposed termination on November 15, 2001. See 42 C.F.R. � 488.402(b) ("remedies are applied on the basis of noncompliance found during surveys"); � 488.417(d) (payments resume on the date the facility achieves substantial compliance as determined on revisit or on a earlier date when CMS can so determine from credible written evidence). (12) The October 19th SOD cites the following examples as violations of the regulatory provisions indicated: (13)
CMS Ex. 16. The alleged facts, in summary, are that: (1) some CNAs cussed or cursed residents and handled residents roughly (Examples 1, 2, 3); (2) the facility failed to report the incidents of cussing and rough handling (Examples 4, 5); and (3) the facility failed to do background checks on some employees before hiring (Example 6). CMS alleges that these facts evidence multiple violations of 42 C.F.R. � 483.13.
My analysis leads me to the conclusion that CMS has failed to make a prima facie case that any abuse occurred as alleged in the October 19th Quick Report. My conclusions in this regard are based upon the elements of the prima facie case and the facts alleged by CMS. To make a prima facie case, CMS must show (1) what regulation applies that was allegedly violated by Petitioner; (2) what facts support its conclusion that there was a violation; and (3) how the violation constitutes noncompliance warranting a remedy. See Hillman. CMS alleges that Petitioner violated 42 C.F.R. � 483.13(b), which provides that a resident has a right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion, and 42 C.F.R. � 483.13(c)(1) through (4) which requires the facility to develop and implement policies to ensure that the resident rights established by the regulation are not violated. I note first, that there is no allegation that Petitioner did not have the policies required by 42 C.F.R. � 483.13(c), which include policies prohibiting the specified conduct, policies regarding reporting the specified conduct, and policies regarding hiring. Petitioner has repeatedly noted that its policies were reviewed during the standard survey in June 2001 and it was not cited as deficient in this area. CMS has not denied that Petitioner had the required policies, but does allege that Petitioner failed to follow or implement its policies. "Cursing" and "rough handling," are not conduct specifically prohibited by the Act or the regulations. CMS's theory is that both cursing and rough handling are prohibited if they constitute verbal or physical abuse - both of which are specifically prohibited by the regulations. If CMS fails to show that the conduct in question amounted to abuse, there is no violation of the regulatory prohibition against abuse. 42 C.F.R. Part 483 does not provide a definition of "abuse" as used in Part 483. However, the Board has in past decisions related to Part 483 applied the definition found at 42 C.F.R. � 488.301. Beverly Health and Rehabilitation Center, DAB No. 1748, fn.6. In this case, CMS specifically argues that the definition from Part 488 should be applied. CMS Post Br., at 10. "Abuse" is defined at 42 C.F.R. � 488.301 to include two elements. Abuse is:
See Beverly Health and Rehabilitation Center-Williamsburg, DAB No. 1748 (2000); Life Care Center of Hendersonville DAB CR542 (1998); Oakwood Manor Nursing Center, DAB CR818 (2001). Thus, for CMS to make a prima facie case it must show that cursing and/or rough handling occurred, that it was willful and for one of the purposes stated, and that there was actual harm, pain, or mental anguish. CMS's allegations are that one or more residents were cursed (14) and that there was rough handling of one or more residents. One source of these allegations is a demented resident whose identification of the offending staff member or members is highly questionable based on her identification of different individuals at different times. Tr. at 93-94, 170. No other residents interviewed by the survey team complained about "verbal abuse." Id. at 172. Other sources are CNAs who are certain that they reported incidents of cursing and rough handling - as they are required to by facility policy and State law on risk of losing their jobs. Tr. at 200. However, they cannot identify specifically to whom they did report. Tr. at 94-97, 180; CMS Ex. 16. CMS cited Petitioner based only upon the general and conclusory allegations of Resident 9 and the CNAs. The testimony was that the surveyors never learned what words were actually said that allegedly constituted cursing. Tr. at 93, 108. The record is also devoid of any description of the alleged rough handling. Tr. at 109. CMS's evidence leaves for speculation what conduct constituted "bad words" or cursing, and rough handling and there is little or no evidence of the circumstances. (15) Thus, it is not possible to determine from either context or content whether the conduct was willful. In fact, CMS presents no other evidence as to whether the conduct alleged to be cursing and rough handling was "willful" for the infliction of injury, unreasonable confinement, intimidation, or punishment. CMS presents no legal authority for the proposition that there is any inference or presumption of willfulness given the facts alleged. CMS's evidence also fails to show that the alleged cussing and rough handling actually resulted in physical harm, pain, or mental anguish. CMS argues, with regard to Resident 9, that her furtive efforts to do her own personal hygiene and dress herself indicate that she was intimidated by the CNA who allegedly cursed her. Tr. at 92, 215. CMS also presented testimony of an expert witness, Louis Burgio, Ph.D., who did not interview Resident 9 but reviewed surveyor's notes, the resident's Minimum Data Set (MDS) and some nursing notes. Dr. Burgio opined that Resident 9 was credible in her compliant that a CNA used bad words. Dr. Burgio further opined that he believed what was said to Resident 9 constituted abuse based on his speculation that the words said were "expletives, swear words." Tr. at 239. Dr. Burgio concluded that Resident 9's furtive actions and stated desire to avoid the CNA was behavior consistent with one who had been abused. Tr. at 240. On cross-examination, Dr. Burgio conceded that individuals with diagnosis such as Resident 9 have good days and bad days, and though he identified no history of fabrication or delusions, he was not aware of Resident 9's medical condition at the time of the alleged incident. Tr. at 250-252. He acknowledged that her MDS indicated that she was not always oriented to person, indicating she might know what is happening, but she might not necessarily know who is doing it. Tr. at 252-253. Dr. Burgio also admitted that knowing that Resident 9 incorrectly accused a CNA of taking her clothing creates a question as to the accuracy of his conclusion that she was not fabricating regarding the allegation that a CNA said bad words in her presence. Tr. at 254. I do not find Dr. Burgio's testimony persuasive given its limited foundation, i.e., he did no personal interview with Resident 9, he was unaware of her medical condition at the time of the report and alleged incident, he admitted that a mental status examination is necessary, and he was unaware of Resident 9's incorrect allegations regarding theft of clothing. Dr. Burgio's testimony also casts significant doubt upon the reliability of Resident 9's actions as an indication of a desire to avoid a CNA. In summary, I conclude that CMS has failed to show facts that establish that any cursing occurred. CMS has also failed to show facts that establish that any rough handling occurred. Absent evidence of cursing or rough handling, I cannot find any "willful infliction of injury." Further, CMS has failed to show any "resulting harm" to any resident, including Resident 9. I cannot find willful infliction of injury with resulting harm, thus I cannot find that any abuse actually occurred and there is no violation of 42 C.F.R. �� 483.13(b) or (c)(1)(i).
The CMS fall-back argument is that, even absent a finding of actual abuse, there were "allegations of abuse" which the facility had a regulatory duty to investigate and report and it did not in violation of 42 C.F.R. �� 483.13(c)(2), (3), and (4). CMS further argues that this shows a failure to implement policies as required by 42 C.F.R. � 483.13(c). Petitioner argues that the "facility" had no knowledge of the alleged incidents and could not investigate and report - essentially a defense of impossibility. The duty of a facility to investigate and report allegations of violations of a resident's rights is based on section 1819(g)(1)(C) of the Act which provides:
I find that the language of 42 C.F.R. � 483.13 is clear and unambiguous when read in conjunction with the statute. The legislative history of the regulation supports my reading of the regulation as do the decisions of the Board and other judges of the CRD. Subsection 483.13(a), which is not involved in this case, establishes a resident's right to be free from restraints. Section 483.13(b) which is involved, establishes a resident's right to be free from abuse. Section 483.13(c) establishes a participating facility's responsibility to ensure that the rights established by �� 483.13(a) and (b) are not violated by the facility or staff. Subsection 483.13(c) requires the development and implementation of facility policy that: (1) prohibits abuse, employment of individuals with a history of abuse, and requires reporting of unfitness for service of staff; (2) requires reporting of "all alleged violations" of the rights established by subsections (a) and (b); (3) requires that the facility have evidence that "all alleged violations" are thoroughly investigated; and (4) requires that the results of any investigation be reported to the Administrator and to other officials within five working days of the incident. The responses of the drafters of � 483.13 to public comment prior to implementation of the section is enlightening on the investigating and reporting requirements of subsections (c)(2), (3), and (4):
This commentary is interesting for it recognizes that Congress put the onus on the State survey and certification agency to handle all investigations, but the Secretary has elected to shift much of that burden to the participating facilities through the regulations. The commentary continues:
56 Fed.Reg. 48,843 (1991) (emphasis added). The drafters of 42 C.F.R. � 483.13(c) are clear that facilities have an important role in identifying and investigating all allegations of violations of resident's rights, but specify that when preliminary investigation implicates staff, then state officials must be notified. The Board recognized in Beverly Health and Rehabilitation Center - Williamsburg, DAB No. 1748 (2000) that the regulatory scheme requires that a participating facility develop and implement a policy that prohibits mistreatment, neglect, abuse and misappropriation and that all allegations be investigated. If there is an allegation of abuse, the policy must require that staff report the allegation to the Administrator. The facility must conduct a "preliminary investigation" and if the allegation of maltreatment or abuse "implicates staff," the State survey and certification agency must be notified. The Board commented upon the need for a preliminary investigation in Carehouse Convalescent Hospital, DAB No. 1799 (2001), a case involving an alleged misappropriation of property. The Board noted that a facility which documents its preliminary investigation, resulting in a finding of no violation of resident's rights, can demonstrate that it complied with the regulations. Id. at 48. If the preliminary investigation reveals that there is an allegation of maltreatment or abuse by staff, the State agency and other officials must be notified in accordance with State law (16) and a complete investigation must be done and submitted within five working days of the occurrence of the alleged incident. 42 C.F.R. � 483.13(c)(4). CMS takes an extreme view that the facility has no obligation or liberty to conduct a preliminary inquiry regarding an allegation of abuse. CMS Post Br., at 15. CMS's position is inconsistent with both the Act and regulations. The Act expressly limits the duty to investigate allegations of neglect, abuse and misappropriation that implicate staff. The legislative history of 42 C.F.R. � 483.13(c) indicates that it is also the intent underlying the reporting and investigation requirements of the regulation. With this understanding of the Act and regulation, how is it possible for the facility to determine whether staff is implicated and that an "allegation" is an allegation of abuse or maltreatment without a preliminary investigation or inquiry? The law seems clear on this point: (1) facility policy must require that all allegations of resident rights be immediately reported to the Administrator or his or her designee who will do a preliminary investigation to determine the nature of the allegations and whether staff is implicated; (2) the facility must report all allegations of abuse that implicate staff to the State agency and other officials as required by State law; (3) the facility must fully investigate allegations of abuse implicating staff and report to the Administrator, the State agency and other State officials in accordance with State law within five working days of the alleged incident. 42 C.F.R. �� 483.13(c)(2) and (4); see also 56 Fed.Reg. 48,843-44 (1991); Beverly Health and Rehabilitation Center - Williamsburg, and Carehouse Convalescent Hospital. However, it is clear that the purpose of the Administrator's preliminary inquiry is only to determine whether there is an allegation of maltreatment, neglect, abuse, or misappropriation and whether staff is implicated, and not to determine whether the allegations are founded. If the allegation involves possible maltreatment or abuse and staff is implicated, reporting is mandatory, whether or not the facility's subsequent full investigation shows that the allegations were not well-founded. The Board's advice, that all investigations be documented to demonstrate regulatory requirements, applies equally to a facility administrator's preliminary inquiry that shows the allegation is not one of maltreatment or abuse or that staff is not implicated, obviating the need for further investigation and reporting. (17) In Oakwood Manor Nursing Center, DAB CR818 (2001), Chief Judge Silva relied upon the Board's decision in Beverly for her conclusion that "proof of actual abuse is not a necessary prerequisite to a deficiency finding under 42 C.F.R. � 833.13(b) . . . a facility is deficient . . . if it either deliberately or negligently acts in some way that presents either actual abuse or the potential for abuse (emphasis in original)." Chief Judge Silva restated the standard of Beverly as "a facility will be deficient under 42 C.F.R. � 483.13(b) if it knows or should know that a potentially abusive event may occur and it does not take reasonably necessary steps to prevent it from happening." Chief Judge Silva rejected any strict liability approach. Chief Judge Silva recognized that the facility's duty to act arises when the facility knows or should know that a potentially abusive event may occur and, when the duty to act is triggered, the facility must take reasonably appropriate steps to prevent the event. The same reasoning applies as well to the duty to investigate and report, i.e., the facility's duty to investigate and report arises when the facility "knows or should know" that there is an allegation of abuse involving a resident that implicates staff. I find no authority for the proposition that strict liability should be imposed for a facility's failure to investigate and report an allegation of abuse of which it did not know or have reason to known. In Life Care
Center of Hendersonville, DAB CR542 (1998), Judge Kessel noted that
the mere presence of episodes of abuse does not answer the question of
whether a facility has implemented a policy to prevent abuse, but evidence
of repeated episodes of abuse or a pattern of abuse may raise the inference
that a policy has not been implemented. Judge Kessel further noted that
the facility in that case "had no reason to investigate 'suspected' abuse
or to report 'suspected' abuse where no evidence existed to demonstrate
even a reasonable probability that a resident was abused." Judge Kessel
opined that the duty to investigate and report under the regulation is
triggered when there is evidence that would cause a reasonable person
to suspect the presence of abuse. Applying the logic of Chief Judge Silva and Judge Kessel in the context of the regulatory scheme, I conclude that an allegation that a reasonable person would recognize as an allegation of abuse or maltreatment, triggers a participating facility's duty to do a preliminary investigation, and if staff is implicated, the duty to fully investigate and report as specified by the regulation. (18) Inherent in this regulatory duty is that the facility management must know or, using Chief Judge Silva's formulation, the facility should know that there is an allegation of abuse before the duty to investigate and report is triggered. One way to ensure that the facility has knowledge is the regulatory requirement that facility policy must require staff to report any allegation of potential abuse to the Administrator or his or her designee. A single failure of a staff member to comply with the policy to report to the Administrator might not indicate the facility's failure to implement the required policy. However, repeated episodes or a pattern of abuse may raise an inference that the facility has not implemented the required policy. I conclude that
CMS met the elements of its prima facie case by showing that there were
"allegations of abuse" (19) and there
was no documentation of any investigation or report by the facility. Because
it is undisputed in this case that the facility had the required anti-abuse
policy and the employees received regular training on the policy (Tr.
at 525-526, 539-540, 572), (20) there
is a reasonable inference that staff immediately reported the allegations
of abuse to the "administrator" as required by the regulation and the
facility policy. (21) Absent evidence
that the facility actually knew of the allegations, CMS's argument is
dependent upon this inference. The inference upon
which the CMS prima facie case relies is, however, subject to being rebutted
and that is exactly what Petitioner has done in this case. Petitioner
presented testimony of Ralph Nelson, Administrator and Craig Cloud, Director
of Support Services, which shows that they had no knowledge of the three
alleged incidents of abuse until the survey team brought the allegations
to their attention. Tr. at 513-516, 577-580. Their testimony is consistent
with and verified by testimony of the surveyors. Surveyor Taylor admitted
on examination that there was no evidence that the facility Administrator,
or his staff, was ever notified of the allegations of cursing and rough
handling prior to the issue being raised by the survey team. Tr. at 98,
168, 170, 186, 207. Furthermore, the evidence clearly shows that the facility
immediately began an investigation pursuant to its policy as soon as the
survey team brought the allegations to the Administrator's attention showing
that the facility had a policy and had the ability to implement it. P.
Exs. 54, 57. CMS has made no allegation that the investigation and report
done were inadequate. Petitioner's case is further bolstered by evidence
that its policy had previously been followed in cases where allegations
of abuse were reported to the Administrator. CMS actually concedes in
its brief that none of the alleged incidents of abuse were brought to
the attention of the Administrator prior to the survey. CMS Post Br.,
at 17-18. Absent CMS's concession, I would still find that there is no
evidence of knowledge of the alleged incidents. There is no question that
Resident 9 first raised her allegations with a State surveyor during the
survey on October 17, 2001. I do not find that the allegations of the
CNAs, that they reported to an unknown nurse and another CNA prior to
the survey, establish that the facility management was given notice of
the allegations. I do not find the allegations of the CNAs (that they
reported) credible given their self-serving nature, their lack of specificity,
the inability of the CNAs to remember to whom they reported, the denial
by supervisory nurses and a lead CNA of having received any report, and
the absence of any document or other evidence that the facility managers
had some information that caused them to know or should know that allegations
had been made. Petitioner has successfully raised, and shown by a preponderance
of the evidence, the defense
of impossibility, i.e., the preponderance of the evidence shows
that the Administrator was not notified by staff of the allegations of
abuse. And, therefore, because he had no knowledge it was impossible for
the Administrator to fulfill his regulatory duty to investigate and report,
or simply report as advocated by CMS. Despite the weight of the evidence that the Administrator had no actual knowledge of the allegations of abuse, CMS attempts to cobble together a theory in support of the alleged violations premised on the theory that the facility should have known of the alleged abuse. CMS initially argues that even absent actual knowledge by the facility managers, the CNAs are part of the facility, and if the CNAs knew, then the facility knew, triggering the obligation for the facility to report. In the alternative, CMS argues that if the allegations were known to the CNAs and they did not report, that constitutes a violation because it shows that the facility policy has not been properly implemented or was not being followed. CMS Post Br., at 15-22; CMS Posthearing Reply (CMS Post Reply), at 6-30. CMS advances several other arguments in support of its position that a violation occurred here whether or not the Administrator ever had actual notice. I understand CMS's position that one purpose of the Act and regulations is to protect the beneficiaries of the Act. However, CMS simply points to no evidence that the facility should have known of the allegations. I have already concluded that Resident 9 never raised a complaint until the surveyor caught her in the bathroom. I have also concluded that the CNAs assertions that they reported to others is also not credible, and even if they did report there is no showing that their reports made it up the chain to management. The CNAs assertions that they knew the abuse policy and did report is also good evidence that the facilities policy was implemented and well known. CMS's allegations of violation of 42 C.F.R. �� 483.13(c)(2)-(4) for failure to implement policy or to investigate and report are unfounded and provide no basis for a DPNA or termination.
CMS alleges that
Petitioner failed to follow its own policies and procedures because it
could not produce documentary evidence that it screened all employees
through the Employment Registry Clearance (the state nurse aide registry).
CMS Ex. 28, at 1; Tr. at 263. The purpose of such a check is to ensure
the facility does not employ an individual who had a finding entered concerning
abuse, neglect, maltreatment or misappropriation of property. Employment
of such persons is a violation of 42 C.F.R. � 483.13(c)(1)(ii). Garland Battles,
a surveyor who participated in the October 2001 survey, testified that
facility policy requires background checks on all direct care employees.
Tr. at 257; P. Ex. 21. Mr. Battles further testified that for three of
five employees whose records he checked, there was no written evidence
that there was a registry check prior to hiring. Tr. at 261; CMS Ex. 28,
at 1. Mr. Battles testified that Petitioner was cited for failure to follow
its own policy and not for a violation of a regulation. Tr. at 263. On
cross-examination, Mr. Battles admitted that the regulations do not require
the documentation he searched for, rather he believed that the facility's
policy required such documentation. Tr. at 265-266. Jo (Steele) Karlson,
another surveyor, checked the records of other employees and she testified
similarly to Mr. Battles. Tr. at 277. Craig Cloud, Director of Support Services for Petitioner, testified regarding his duties at Petitioner's facility which include overseeing the hiring process which required background checks and policy-making. Tr. at 491-563. Mr. Cloud is credible. He testified that it is facility policy to check the employment registry (22) before an offer of employment is made to a direct care employ, this is the policy and this is how staff is trained. Tr. at 502. There is nothing in the facility policy that requires written documentation that a registry check was done, as no offer of employment would be made absent such a check. Tr. at 503, 511-512. Criminal background checks are done after employment. Tr. at 549-550. Mr. Cloud testified that in his opinion the regulation (42 C.F.R. � 483.13(c)(1)(ii)) prohibits hiring anyone with an adverse entry on the registry and the facility demonstrates compliance because if the surveyors check the employees they will find that none have an adverse entry. Tr. at 549-550. CMS bears the initial burden of presenting sufficient evidence to show a prima facie case. CMS must (1) identify the statute, regulation, or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions; and (3) show how the deficiencies it found amount to noncompliance which warrant an enforcement remedy. See Hillman. CMS has failed to show a prima facie case for this deficiency as it has not shown the statutory, regulatory or other legal standard to which it seeks to hold Petitioner. The Act imposes no direct obligations on facilities regarding checking the employment registry. Act, section 1819(g). Further, as Mr. Cloud testified, 42 C.F.R. � 483.13(c)(1)(ii) prohibits facilities from hiring individuals with adverse entries. The regulation does not specify how facilities are to avoid violations, and the regulation neither requires that agency checks be done or that they be recorded in anyway. I agree with the CMS position that by recording that checks have been done, the facility can demonstrate attempted regulatory compliance. (23) However, nothing in the regulation specifies how or when registry checks be done or that they be recorded. If the Secretary had intended that the facility should produce written evidence that checks were done, then the regulation should have included the specific requirement, similar to that of 42 C.F.R. � 483.13(c)(3) which does require that the facility be able to show evidence. Finally, my review of the facility's policy (P. Ex. 21) is consistent with the testimony of Mr. Cloud. I find nothing in the facility's policy that requires maintaining any sort of written evidence that a registry check was done for a new hire. I conclude with respect to this deficiency, that CMS has failed to establish a statutory, regulatory or other legal requirement to which it seeks to hold Petitioner. Accordingly, CMS has failed to establish a prima facie case on this alleged deficiency.
The evidence shows that all deficiencies cited by the September 2001 survey were cleared by the October 19th survey. Thus, as of October 19, 2001, there was no longer a basis for a continuing DPNA. The evidence also shows that CMS did not propose termination based on any deficiencies other than those cited in the October 2001 Quick report. See Tr. at 375-376. However, none of the deficiencies cited on the October 2001 Quick report withstand scrutiny, and there is no basis for the proposed termination. V. CONCLUSION For the foregoing reasons, the imposition of a DPNA for the period September 7, 2001 though October 16, 2001 is approved as the remedy has a basis and it is reasonable. After October 16, 2001, there is no basis for a continuing DPNA or the proposed termination of Petitioner's provider agreement. Petitioner was in substantial compliance as of October 16, 2001. |
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| JUDGE | |
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Keith W. Sickendick Administrative Law Judge |
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| FOOTNOTES | |
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1. The termination date changed from November 7, 2001 to December 7, 2001 to November 15, 2001. The reason for the changes is not pertinent to disposition of this case. 2. Judge Moody converted the TRO to a preliminary injunction on November 21, 2001. 3. Gaps in exhibit numbers represent exhibits not offered by CMS. I note that both parties omitted exhibits admitted at hearing from their listing of exhibits attached to their posthearing briefs. 4. Scope and severity levels are used by CMS and the State when selecting the appropriate remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the State from the scope and severity matrix published in the State Operations Manual (SOM), section 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm, but with potential for minimal harm. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. � 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but with potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are given deficiencies that constitute immediate jeopardy to resident health or safety. The matrix, which is based on 42 C.F.R. � 488.408, specifies which remedies are required and optional at each level based upon frequency of the deficiency. See SOM, section 7400E. 5. The October 19, 2001 SOD cites only 42 C.F.R. � 483.13(c)(1)(ii) at F Tag 225. However, the allegations encompass 42 C.F.R. � 483.13(c)(1)(ii) and (iii), and subsections (2) through (4). 6. Petitioner specifies that it does not appeal from the July 31st SOD that contains no immediate jeopardy findings. There was another July 31st SOD that cited Petitioner for a deficiency that created immediate jeopardy and/or identified a past circumstance of immediate jeopardy. However, the immediate jeopardy SOD was effectively withdrawn by action of the State survey agency and CMS. P. Exs. 3, 4. 7. Cross Creek Health Care, DAB No. 1658 (1998) and Lake City Extended Care Center, DAB No. 1658 (1998), make clear that I can review scope and severity when I do not uphold each of the surveyor's findings that were considered when scope and severity was decided by CMS. 8. The two regulations allegedly found violated on the September 14th SOD are also listed on the July 31st SOD, but different examples are cited by the State agency as constituting violations. 9. CMS's notice dated October 5, 2001, superceded the notice dated October 3, 2001. The October 5th notice reflects that the State agency recommended an extension of the termination date to December 7, 2001, to accord Petitioner additional time to achieve substantial compliance. CMS Exs. 1, 2. In other respects, the notices are the same. 10. Petitioner advances the argument that the condition of Residents' 2 and 6, the cited examples, had changed which could justify not complying with their plan of care. However, the regulation requires timely changes in the plan of care when there is a "significant change" in the resident's physical or mental condition. 42 C.F.R. � 483.20(b)(2)(ii). 11. Petitioner's counsel did get both CMS witnesses to concede that total daily caloric intake is more important to prevent weight loss than whether a resident received Boost with meals or between meals (Tr. at 66, 84). However, that concession does not show that the residents actually received Boost or that Petitioner was actually in compliance with the resident's doctor's orders and the plan of care. 12. Petitioner has not presented evidence that there was credible written evidence that substantial compliance was achieved between the September 14 revisit and the October 19 revisit. 13. Other examples are alleged in the October 19 th Quick Report, but CMS elected to proceed only upon those listed herein. Tr. at 31-34, 123. Examples are numbered for ease of reference. 14. Geneva Taylor, the State surveyor involved with the allegations related to Resident 9, testified that Resident 9 alleged that "bad words" were said to her. Ms. Taylor admitted on examination that she assumed that the "bad words" were curse words. Tr. at 102, 146-148. She asserted however that Resident 9 later alleged that she had been cursed. 15. In a statement to the facility's investigator on October 17, 2001, Resident 9 stated that a CNA cursed her saying "Hurry up damn it, I don't have all day." P. Ex. 53, at 1, 54, at 15. CMS has not alleged that "damn it" is the cursing or "bad words" that are at the root of its abuse charge. Webster's New World Dictionary (2d ed. 1979) includes five definitions of "damn," only one of which treats "damn" as a curse word or its use swearing. 16. The legislative history of 42 C.F.R. � 483.13(c)(2) and (4) at 56 Fed.Reg. 48,844 (1991) makes clear that the intent of the reference to State law, which appears in both sections, is that reports to state agencies (including the state survey and certification agency) will be done in accordance with the procedures specified in State law. This interpretation is consistent with the absence of such procedures for reporting in the federal regulations. It is also consistent with the fact that section 1819(g)(1)(C) of the Act (42 U.S.C. � 1395i-3(g)(1)(C)) imposes upon the States the duty to establish the process even absent regulations from the Secretary (Act, section 1819(g)(1)(E)). Reporting of both the allegations (42 C.F.R. � 483.13(c)(2)) and the results of investigation (42 C.F.R. � 483.13(c)(2)) is obligatory. 17. I perceive no inconsistency in the State law or regulations. Ark. Code Ann. � 5-28-101 et. seq. and � 12-12-501 et. seq.; Tr. at 364 (testimony Frank Gobell, Attorney, Assistant Program Administrator, Office of Long-Term Care). 18. 42 C.F.R. � 483.13(c)(4) requires completion of the full investigation and a report to State officials in accordance with State law within five days. Arkansas state law imposes an additional reporting requirement in that if there is reasonable suspicion of abuse the facility must alert the State agency by 11:00AM the next business day. 19. I accept for purposes of this analysis that a resident's allegation that they were cursed or handled roughly or a staff member's allegation that they witnessed such, is an "allegation of abuse." Whether the allegation is later proved is not controlling. See, e.g., Oakwood Manor Nursing Center, DAB CR818 (2001). 20. The unrebutted testimony of Mr. Craig Cloud, Director of Support Services for Petitioner, is that staff received training an average of monthly and no less than quarterly. 21. I do not accept the CMS "imputed or constructive knowledge" theory that because a staff member knows the "facility" knows. The regulations refer to the facility as the skilled nursing or nursing "entity which participates" in the Medicare or Medicaid program. 42 C.F.R. � 483.5. There is no indication in the statute or regulations that the Secretary is entering participation agreements with CNAs and other staff employed by the facility. CMS cited no authority which supported this theory, and appears to abandon it in its posthearing reply brief. 22. The "employment registry" is referred to as Maltreatment Services Registry check or the State nurse's aide registry in the actual policy. P. Ex. 22, at 6; Tr. at 504. CMS refers to as the Employment Clearance Registry. CMS Br., at 23. I am convinced all references relate to the same employment registry. 23. Simply checking the registry and recording that a check was done prior to employment does not necessarily satisfy the regulation. The regulation prohibits employment of individuals with a finding of guilty by a court of law or an adverse entry on the registry. Thus, even though a check is done, the regulation is violated if a facility employees an individual who has an adverse entry posted after the date of hire. |
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