SUBJECT:

Heron Pointe Health and Rehabilitation,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Heron Pointe Health and Rehabilitation, violated 42 C.F.R. � 483.20 ⁽¹⁾ with respect to one resident as found by a survey of the facility completed on October 2, 2002, and as alleged by the Centers for Medicare & Medicaid Services (CMS). There is a basis for the imposition of a civil money penalty (CMP) and a CMP of $7,000 per day for one day, is reasonable.

I. Background

Petitioner is a long-term care facility located in Brooksville, Florida. Petitioner is authorized to participate in the federal Medicare program as a skilled nursing facility (SNF) and in the Florida State Medicaid program as a nursing facility (NF). On October 1, 2002, Petitioner reported the death of Resident 1 to the Florida Agency for Health Care Administration (the state agency). State agency surveyors conducted a survey at Petitioner's facility on October 1 and 2, 2002. The results of the survey are set forth in a statement of deficiencies (SOD) dated October 2, 2002. CMS Exhibit (CMS Ex.) 4. The state agency notified Petitioner by letter dated October 3, 2002 that it found Petitioner in violation of four participation requirements; that there was a immediate jeopardy; and that the matter was being forwarded to CMS with the recommendation that CMS impose a CMP of $10,000 per day effective October 2, 2002, a denial of payment for new admissions (DPNA) effective October 9, 2002, and termination of its Medicare agreement effective October 24, 2002. CMS Ex. 3. CMS notified Petitioner by letter, dated October 7, 2002, that it concurred with the state agency findings and recommendations and that it was imposing a CMP of $10,000 per day beginning effective October 2, 2002 and continuing until immediate jeopardy was removed, substantial compliance was achieved, or the facility's participation agreement was terminated. CMS Ex. 5. A revisit survey on October 9, 2002 found that Petitioner was again in substantial compliance, and the DPNA and termination remedies were cancelled. CMS Exs. 11, 12.

Petitioner's request for hearing by an administrative law judge (ALJ) was received by CMS on December 9, 2002. The case was assigned to me for hearing and decision on December 30, 2002. I held a hearing in St. Petersburg, Florida on December 2 and 3, 2003, and the proceedings are recorded in a transcript (Tr.) with pages numbered 1 through 177 and 251 through 455; there are no pages 178 through 250. CMS Exhibits 1 through 18 and Petitioner's Exhibit (P. Ex.) 1 were offered and admitted as evidence. Tr. at 22, 33-34. Deborah Olsen, the state surveyor who prepared the SOD in this case (Tr. at 53-109); Allison Onufer Hillhouse, a supervisor in the state survey agency (Tr. at 119-142); and Ann Sarantos, a survey integrity support manager for the state agency (Tr. at 417-446), testified at the call of CMS. Scott Howard Smith, Petitioner's administrator (Tr. at 157-167); Sandy Lynn Garcia, a licensed practical nurse who cared for Resident 1 (Tr. at 260-329); Christina Marie Bell, a charge nurse for the wing on which Resident 1 resided (Tr. at 331-354); and Billie H. Brock, a registered nurse qualified as an expert witness (Tr. at 356-412); testified on behalf of Petitioner. The parties submitted post hearing briefs (CMS Brief and P. Brief, respectively) and reply briefs (CMS Reply and P. Reply, respectively).

II. Discussion

A. Findings of Fact

The following findings of fact are based upon the exhibits admitted. Citations to exhibit numbers related to each finding of fact may be found in the Analysis section of this decision if not indicated here.

1. Petitioner, located in Brooksville, Florida, is authorized to participate in the federal Medicare program as a SNF and in the Florida State Medicaid program as a NF.

2. On October 1, 2002, Petitioner reported the death of Resident 1 to the state agency.

3. State agency surveyors conducted a survey at Petitioner's facility on October 1 and 2, 2002, and concluded that Petitioner was in violation of 42 C.F.R. �� 483.13(a) (Tag F 221), 483.13(c)(1)(i) (Tag F 224), 483.483.20(k)(3)(i) (Tag F 281), and 483.75 (Tag F 490), all cited at a scope and severity level of J, and all related to Resident 1. CMS Ex. 4.

4. The state agency notified Petitioner by letter dated October 3, 2002, that it found Petitioner in violation of four participation requirements; that there was immediate jeopardy; and that the matter was being forwarded to CMS with the recommendation that CMS impose a CMP of $10,000 per day effective October 2, 2002, denial of payment for new admissions (DPNA) and termination. CMS Ex. 3.

5. CMS notified Petitioner by letter, dated October 7, 2002, that it concurred with the state agency findings and recommendations, and that it was imposing a CMP of $10,000 per day beginning October 2, 2002 and continuing until immediate jeopardy was removed, substantial compliance was achieved, or the facility's participation agreement was terminated. CMS Ex. 5.

6. The state agency found that Petitioner achieved substantial compliance on October 9, 2002. CMS Exs. 11, 12.

7. Petitioner's request for hearing by an ALJ was received by CMS on December 9, 2002.

8. Resident 1 was admitted to Petitioner's facility on March 4, 2002, with diagnoses including congestive heart failure, decubitus ulcers, dementia, and adult failure to thrive, among others. Resident 1 had a feeding tube, an indwelling urinary catheter, and had severely-impaired decision-making skills. CMS Ex. 8, at 18-23; P. Brief at 3; CMS Brief at 2.

9. Resident 1 was placed on hospice care on August 22, 2002, due to her physician's determination that she was terminal. P. Ex. 1; CMS Ex. 8, at 16, 28.

10. Resident 1 had a pressure ulcer on her left hip and she removed the dressing from the wound and scratched it until it became a severe wound.

11. Medication to relieve Resident 1's itching was minimally effective as were other interventions attempted by Petitioner.

12. One intervention Petitioner's staff used was placing examination gloves on the resident's hands, but this intervention was stopped around the end of September 2002 because the resident started removing the gloves.

13. Early on the morning of October 1, 2002, Resident 1 became increasingly agitated, pulled out her urinary catheter and pulled on her feeding tube, and a certified nurse assistant (CNA) placed examination gloves on the resident's hands sometime before 4:00 AM.

14. At 6:00 AM on October 1, 2002, Resident 1 was observed to no longer be wearing gloves and was no longer fidgeting.

15. Around 9:00 AM, Resident 1 was found dead in bed with one of the examination gloves in her mouth.

16. The medical examiner ruled that Resident 1 died due to airway obstruction by a foreign object, the glove found in her mouth. CMS Exs. 15, 16.

B. Conclusions of Law

1. Petitioner's request for hearing was timely and I have jurisdiction.

2. Petitioner did not violate 42 C.F.R. � 483.13(a) (Tag F 221), as the gloves placed on the hands of Resident 1 were not restraints.

3. CMS has failed to make a prima facie showing of a violation of either 42 C.F.R. � 483.13(c) or � 483.13(c)(1)(i) (Tag F 224).

4. Petitioner violated 42 C.F.R. � 483.20 with regard to Resident 1.

5. CMS has failed to make a prima facie showing that Petitioner violated 42 C.F.R. � 483.75 (Tag F 490).

6. The unrebutted evidence is that all corrective actions required to bring Petitioner into substantial compliance, corrective actions ultimately accepted as adequate by CMS and the state, were actually completed by October 2, 2002.

7. Petitioner's violation of 42 C.F.R. � 483.20 provides a basis for the imposition of a CMP.

8. A total CMP of $70,000 is not reasonable in this case, but a total CMP of $7,000 is reasonable.

C. Issues

The issues in this case are:

�Whether there is a basis for the imposition of an enforcement remedy; and,

�Whether the remedy imposed, a CMP of $10,000 per day for the period October 2 through 9, 2002, is reasonable.

D. Applicable Law

Petitioner is a long-term care facility participating in the federal Medicare program as a SNF and in the state Medicaid program as a NF. The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (Act) and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Facilities that participate in Medicare may be surveyed, on behalf of CMS, by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10-488.28, 488.300-488.335. Pursuant to 42 C.F.R. Part 488, CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406; 488.408; 488.430. The regulations at 42 C.F.R. Part 488 also give CMS a number of other remedies that can be imposed if a facility is not in compliance with Medicare requirements. Id. Pursuant to 42 C.F.R. � 488.301, "(i)mmediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." (Emphasis in original). Further, "(s)ubstantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." Id. (emphasis in original).

The regulations specify that a CMP, which is imposed against a facility on a per day basis, will fall into one of two ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMP, from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2). The lower range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(1)(ii).

The Act and regulations make a hearing before an ALJ available to a long-term facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al., DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991). A 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, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14), (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by an ALJ is governed by 42 C.F.R. � 488.438(e).

When a penalty is proposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "(s)ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8^th ed. 2004); see also, Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (G.E.B.), slip op. at 25 (D.N.J. May 13, 1999). To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997).

E. Analysis

CMS alleges, based upon the survey completed on October 2, 2002, that Petitioner violated 42 C.F.R. �� 483.13(a) (Tag F 221), ⁽²⁾ 483.13(c)(1)(i) (Tag F 224), 483.20(k)(3)(i) (Tag F 281), and 483.75 (Tag F 490); all cited at a scope and severity level of J. CMS Ex. 4. All four alleged violations relate to Resident 1 and arise from the same basic facts about which there is little dispute. Tr. at 38-51. Resident 1 was admitted to Petitioner's facility on March 4, 2002, with diagnoses including congestive heart failure, decubitus ulcers, dementia, and adult failure to thrive, among others. Resident 1 had a feeding tube, an indwelling urinary catheter, and had severely-impaired decision-making skills. CMS Ex. 8, at 18-23; P. Brief at 3; CMS Brief at 2. Resident 1 was placed on hospice care on August 22, 2002, due to her physician's determination that she was terminal. P. Ex. 1; CMS Ex. 8, at 16, 28. Resident 1 developed a pressure ulcer on her left hip. She removed the dressing from the wound and scratched it until it became a severe wound. She also dislodged her feeding tube and catheter. Medication to relieve her itching was minimally effective as were other interventions attempted by Petitioner. One such intervention was placing examination gloves on the resident's hands, but this intervention was stopped toward the end of September, 2002 because the resident started removing the gloves. However, on October 1, 2002, Resident 1 became increasingly agitated, she pulled out her urinary catheter and pulled on her feeding tube. A CNA placed examination gloves on the resident's hands sometime before 4:00 AM. At 6:00 AM, Resident 1 was observed to no longer be wearing gloves and was no longer fidgeting. Around 9:00 AM, Resident 1 was found dead in bed with one of the examination gloves in her mouth. P. Brief at 4-5; CMS Brief at 2-3. The medical examiner ruled that Resident 1 died due to airway obstruction by a foreign object, the glove found in her mouth. CMS Exs. 15, 16.

1. Petitioner did not violate 42 C.F.R. � 483.13(a) (Tag F 221).

Congress has specifically legislated regarding the use of restraints in long-term care facilities. Sections 1819(c)(1)(A)(ii) (SNFs) and 1919(c)(1)(A)(ii) (NFs) of the Act provide that a resident has a right to be free from "any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident's medical symptoms." Furthermore, restraints may only be imposed to "ensure the physical safety of the resident or other residents" and "only upon the written order of a physician that specifies the duration and circumstances under which the restraints are to be used . . . ." An exception is provided for emergency circumstances to be defined by the Secretary in his regulations.

The regulation provides:

(a) Restraints. The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.

42 C.F.R. � 483.13(a). Neither the Act nor the regulation specifically defines the term "restraint." Both parties (CMS Brief at 11; P. Brief at 6) call my attention to the definition of "restraint" found in the SOM in the Guidance to Surveyors, Appendix PP at PP-44 (CMS Ex. 18, at 2) which states:

"Physical Restraints" are defined as any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body.

A separate provision at PP-45 (CMS Ex. 18, at 3) explains that:

Physical Restraints are defined as any manual method or physical or mechanical device, material or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body.

"Physical restraints" include, but are not limited to, leg restraints, arm restraints, hand mitts, soft ties or vests, lap cushions, and lap trays the resident cannot remove easily. Also included as restraints are facility practices that meet the definition of a restraint, such as:

�Using side rails that keep a resident from voluntarily getting out of bed;

�Tucking in or using velcro to hold a sheet, fabric, or clothing tightly so that a resident's movement is restricted;

�Using devices in conjunction with a chair, such as trays, tables, bars or belts, that the resident can not (sic) remove easily, that prevent the resident from rising;

�Placing a resident in a chair that prevents a resident from rising; and

� Placing a chair or bed so close to a wall that the wall prevents the resident from rising out of the chair or voluntarily getting out of bed.

* * * *

The same device may have the effect of restraining one individual but not another, depending on the individual resident's condition and circumstances.

The SOM is CMS's guidance to surveyors. It is a set of interpretive rules, not promulgated by notice and comment rule-making and, thus, the SOM does not have the force or effect of law. Erringer v. Thompson, 371 F.3d 625 (9^th Cir. 2004); Avol v. Sullivan, 883 F.2d 659 (9^th Cir. 1989); Beverly Health & Rehabilitation Services v. Thompson, 223 F. Supp. 2d 73 (D.D.C. 2002)); see also, Cross Creek Health Care Center, DAB No. 1665 (1998). ⁽³⁾ However, the SOM, through its definitions and examples, provides us insight as to how CMS and the Secretary intend for surveyors to interpret the applicable law when performing surveys. Thus, consideration of the SOM provisions is valid and helpful to understand the nature and intent of surveyor and CMS allegations and their construction of the law allegedly violated. In this case, the SOM makes clear that the determination of whether a device or technique is a "restraint," within the meaning of the Act and regulations, is a factual determination warranting consideration of all the facts, including the resident's abilities and limitations.

The surveyor, Ms. Olsen, alleges in the SOD that Petitioner failed to ensure that Resident 1 "was free of any restraint for which a medical symptom was not indicated." CMS Ex. 4, at 1. The surveyor alleges that the use of gloves to prevent Resident 1 from digging at and scratching her wound "was not assessed by the facility for use, fit, or safety of the resident while in the gloves, no doctor's order or medical symptom was recorded to justify the need for the gloves, no care plan was developed to indicate when the gloves were to be applied, and how the facility would monitor the gloves when they were on the resident." Id. The surveyor also alleges that the "lack of assessment, monitoring, and care planning creates a situation that caused serious harm to resident #1 who was found deceased with both gloves off his/her hands . . . ." Id. CMS advances the same contentions in its post hearing brief. CMS Brief at 9-10.

Petitioner argues that the gloves placed on Resident 1, early in the morning on October 1, 2002, were not used as a restraint and CMS has thus failed to make a prima facie showing of a violation of 42 C.F.R. � 483.13(a).

I conclude that the placement of gloves on the hands of Resident 1 on the morning of October 1, 2002 was not a physical restraint within the meaning of the Act and regulations. The definition of physical restraint provided by the SOM has four requirements: (1) a manual method, physical or mechanical device, material or equipment; (2) attached or adjacent to the resident's body; (3) that the individual cannot remove easily; and (4) which restricts freedom of movement or normal access to one's body. While the first two requirements are satisfied in this case, the latter two are not.

The examination-type gloves applied to the hands of Resident 1 the morning of October 1, 2002 were a physical material attached or adjacent to the resident's body, so the first two elements of the definition are satisfied. However, there is no dispute that Petitioner's staff had stopped applying gloves in September, 2002 because Resident 1 could and did easily remove them. The surveyor, Ms. Olsen, testified that she did not know whether or not the resident could easily remove the gloves. Tr. at 61. However, there is no dispute that, on October 1, 2002, Resident 1 removed the gloves and one was found in her mouth. This is not a situation where mitts are tied to the resident's wrists to prevent their removal, or a situation where socks or gloves are taped to her wrists to make removal difficult. Thus, the third element of the definition is not satisfied.

It is clear that the gloves applied to the resident did not restrict her freedom of movement - there is no evidence to suggest that the resident did not have freedom of movement of her hands and fingers. The question of whether or not the gloves restricted "normal access" by the resident to her body is not so clear. Petitioner concedes there was probably some "diminishment of tactile sensation" for the resident due to the gloves. However, I do not find that admission dispositive. Based upon the pictures of similar gloves provided by CMS (CMS Ex. 8, at 74-75), aside from some possible diminishment of tactile sensation, the type of gloves pictured would not restrict hand movement or individual finger movement. Thus, even with the gloves in place, the resident could reach, touch and probe her wound and any other part of her body. While the gloves might reduce the amount of friction created between finger tip and skin or wound surface when rubbing, I do not consider that loss of friction to be more than de minimis restriction of "normal access" by the resident to her body. The gloves might also reduce the effect caused by scratching the skin or a wound with a finger nail, however little more so than if the facility simply cut the resident's nails very short. Based upon the government's pictures of similar gloves, it does not appear that the gloves would actually reduce to any significant degree the effect of scratching with the finger nails.

I conclude that application of the gloves did not restrict Resident 1 from normally accessing her body except for a slight reduction in tactile sensation, a slight reduction in friction caused by rubbing the finger tips against the skin or a wound, and a slight reduction in the effect of scratching with the finger nails. Further, these slight restrictions were easily eliminated if Resident 1 removed the gloves, an ability she clearly demonstrated.

Because I conclude that the gloves placed on Resident 1's hands on the morning of October 1, 2002 were not a physical restraint, I must conclude that CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.13(a) (Tag F 221).

2. CMS has failed to make a prima facie showing of a violation of either 42 C.F.R. � 483.13(c) or � 483.13(c)(1)(i) (Tag F 224).

Title 42 C.F.R. � 483.13(c) provides:

(c) Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

Subsection (1) of the regulation provides:

(1) The facility must -

(i) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion; . . . .

42 C.F.R. � 483.13(c)(1)(i). ⁽⁴⁾

The SOD is confusing regarding what the surveyor really intended by her allegations. The surveyor cites 42 C.F.R. � 483.13(c)(1)(i) and Tag F 224, but actually quotes the language of 42 C.F.R. � 483.13(c) in the SOD. CMS Ex. 4, at 8. The surveyor's detailed allegation is that Petitioner failed to prevent neglect of Resident 1 by "neglecting to assess, monitor, and care plan a device applied to the resident's hand (latex glove) . . . that caused serious harm to resident #1 . . . ." Id. CMS alleges the same before me in its brief. CMS Brief at 15.

Upon examination of the SOD and CMS Brief, I do not construe the allegations of the SOD under Tag F 224 to be that Petitioner violated 42 C.F.R. � 483.13(c) which requires that the facility "develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property." The surveyor does not allege in the SOD that Petitioner did not have and implement the policies required by 42 C.F.R. � 483.13(c); there is no evidence presented that such policies did not exist; and I will not infer from the one alleged incident of neglect in this case that there was a general failure to implement the required policies. In fact, the weight of the evidence is that such policies were implemented at Petitioner's facility. Tr. at 159-161.

The allegation here is that Petitioner neglected Resident 1. However, that charge will simply not lie under the regulatory provision cited by the surveyor - 42 C.F.R. � 483.13(c)(1)(i). The regulation prohibits the facility or its employees from using verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion. This regulatory provision does not specifically prohibit "neglect" except, possibly, to the extent that neglect might be abuse. However, "abuse" means the "willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish." 42 C.F.R. � 488.301. I do not construe the surveyor's allegations to be that Petitioner abused Resident 1 and the term "abuse" is not used by the surveyor or CMS.

Neglect, in the context of long-term care facilities, is the "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. � 488.301; CMS Ex. 18, at 8. The Secretary has regulated comprehensively in the area of long-term care facilities in 42 C.F.R. Part 483. While the Secretary has not eliminated the need for professional judgment in the delivery of services, the Secretary has specified the goods and services that must be delivered. The Secretary has specified that quality of care must be such that each resident receives the care and services necessary to attain or maintain the highest practicable well-being as determined by comprehensive assessment and care planning, the requirements of which are also specified in the regulations. See 42 C.F.R. �� 483.25 (Quality of Care), 483.15 (Quality of Life). The Secretary has also established regulatory requirements for nursing services, physician services, pharmacy services, dietary services, rehabilitative services, infection control, physical environment. See 42 C.F.R. �� 483.30, 483.35, 483.40, 483.45, 483.60, 483.65, 483.70. The Secretary has promulgated standards for administration of long-term care facilities (42 C.F.R. � 483.75) and has specified resident rights which must be observed (42 C.F.R. �� 483.10, 483.12). Because the Secretary has regulated comprehensively, specifying the nature and quality of care and services that must be delivered, there are few, if any, circumstances where "neglect," i.e., the failure to provide goods and services necessary, would not be chargeable as a violation of one of the Secretary's specific regulatory requirements imposed upon long-term care facilities. In this case, for example, the surveyor alleges that Petitioner neglected to assess and care plan the use of gloves. The Secretary's regulation requiring assessment and care planning is 42 C.F.R. � 483.20, and the neglect alleged under this tag might be more appropriately charged under that regulation.

If there is a general regulatory provision that may be the basis for a charge of neglect against a facility, CMS has failed to identify it in this case - 42 C.F.R. � 483.13(c) and its subparts clearly are not such provisions. ⁽⁵⁾ According to decisions of the Board, 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, or that it had an affirmative defense. Emerald Oaks, DAB No. 1800; Cross Creek Health Care Center, DAB No. 1665; Hillman Rehabilitation Center, DAB No. 1611. The Board's definition of the requirements for a prima facie case from Hillman is helpful in resolving this case:

HCFA [now known as CMS] must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611, at 8. Thus, CMS has the initial burden of showing that its decision to impose a remedy 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 that are disputed by Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy. CMS has failed to show which statute, regulation, or legal criteria it seeks to hold Petitioner. The allegations of a violation simply do not fall within the scope of the regulations cited by the surveyor or CMS in this instance. CMS has failed to make a prima facie showing of a violation of either 42 C.F.R. � 483.13(c) or � 483.13(c)(1)(i).

3. Petitioner violated 42 C.F.R. � 483.20 with regard to Resident 1.

In the area of care planning, the Secretary requires that:

The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity.

42 C.F.R. � 483.20. Based upon its comprehensive assessment of each resident, the facility must then develop a comprehensive care plan that includes "measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs . . . ." 42 C.F.R. � 483.20(k). The comprehensive care plan must describe the services to be provided to the resident to meet the goal specified by 42 C.F.R. � 483.25, i.e., "to attain or maintain the highest practicable physical, mental, and psychosocial well-being . . . ." The care plan must be developed by the resident's interdisciplinary care team which includes the attending physician, a registered nurse, and staff representing other disciplines according to the resident's need, and the resident or representative. 42 C.F.R. � 483.20(k)(2)(ii). The services provided under the care plan must "(m)eet professional standards of quality . . . ." 42 C.F.R. � 483.20(k)(3)(i).

The surveyor alleges in the SOD, under Tag F 281, that Petitioner failed to deliver services that met professional standards of quality. The surveyor alleges that:

(T)he facility failed to ensure . . . that licensed/certified staff administered care in accordance with accepted professional standards of practice for use of latex gloves for prevention of scratching and digging behavior . . . .

CMS Ex. 4, at 11. CMS presented no evidence that supports the allegation that there are "accepted professional standards of practice for use of latex gloves for prevention of scratching and digging behavior." However, recognizing that the surveyor who drafted the SOD did not do so with the skill or view of an attorney, I do not read her allegation literally. Rather, I read the allegations related to this alleged violation to determine whether, within its four corners, one may find that there is an alleged violation, and whether the allegations are specific enough to give Petitioner notice of what it must defend. ⁽⁶⁾

The SOD includes six numbered "findings" under Tag F 281. CMS Ex. 14, at 11-13. Finding 1 alleges that Resident 1's records show she had a problem with scratching, removing dressings from her hip wound, and digging in the wound. Id. at 11. These facts are undisputed. Findings 2 and 5 allege that one or more nurses had placed rubber gloves on Resident 1's hands as a means to deter or prevent the resident from scratching and digging at her wound; however, the intervention was not effective and had been discontinued. Findings 2 and 5 also allege, and it is undisputed, that no assessment was done or physician's order obtained for the use of the gloves. Id. at 12, 13. Findings 3 and 4 allege the undisputed facts that, on October 1^st, a nursing assistant, who had previously seen gloves placed on Resident 1, decided to apply gloves again and the resident was subsequently found dead with a glove in her mouth. Id. at 12. A fair reading of the totality of Tag F 281 is that Petitioner failed to properly assess, and then plan for, the use of the rubber gloves as an intervention to prevent or mitigate Resident 1's scratching and digging at her wound. The surveyor's more narrow and specific allegation, that the services provided or arranged by Petitioner did not "meet professional standards of quality" under 42 C.F.R. � 483.20(k)(3)(i), clearly falls within the broader requirement of 42 C.F.R. � 483.20 to properly assess and then care plan for the resident based upon that assessment. Certainly the regulation contemplates that the delivery of services, which meet professional standards of quality, first requires proper assessment of a resident and planning for the delivery of the services. I conclude that, given the allegations of Tag F 281 and the language of the regulation, Petitioner was sufficiently noticed of the allegations against which it needed to defend, i.e., that it failed to properly assess Resident 1 prior to using an intervention, thus failing to provide services meeting professional standards of quality. In fact, Petitioner specifically defends its failure to assess and care plan for the use of the gloves in its brief, relying upon the testimony of witnesses it presented at hearing. P. Brief at 10, 13.

Petitioner asserts that the use of the gloves on Resident 1 was merely a nursing intervention, and nurses routinely use such interventions daily with no requirement to assess, care plan, or obtain a physician's order. Petitioner equates the gloves to such nursing interventions as positioning resident's pillows, use of "distractive measures," and use of compresses. P. Brief at 10, 13. Petitioner cites the testimony of Sandy Garcia, a licensed practical nurse (LPN), employed by Petitioner (Tr. at 260-62, 273-74, 312-13), and Billie Brock, a registered nurse (RN) retained by Petitioner to testify as an expert regarding the standard of nursing care in long-term care facilities (Id. at 356-62, 370-73), to support its position that there are some nursing interventions that do not require care planning and a physician's order. While it seems perfectly reasonable that nurses and aides use interventions that will comfort their patients and some of those interventions may never be listed on the care plan, the problem for Petitioner is that such an approach, even if justifiable in some cases, leaves Petitioner with no documentation that interventions were assessed for safety, that the interventions were assessed and found to be appropriate to meet the quality of care standard established by the regulations (42 C.F.R. � 483.25), or that the interventions were assessed and determined to be necessary to meet other regulatory requirements. Allowing nurses to use interventions without assessment and care planning also leaves Petitioner with no documentation that the interventions were actually used to meet quality of care and other regulatory requirements, no documentation to show the effectiveness of the interventions, and no documentation to establish that the interventions were reasonable. The lack of documentation becomes problematic for Petitioner when, as here, an intervention for which there is no documentation of assessment or planning, created the potential for or actually resulted in harm to the resident. CMS need only make a prima facie showing of a regulatory violation. In this case, there is no question that CMS has made a prima facie showing based upon the facts that: (1) there is no dispute that Resident 1 had problems with removing a bandage and scratching and probing a wound with her fingers exacerbating her wound, which shows that there was a need to provide care or a service to the resident; (2) that one or more nurses and a nurse aide placed rubber gloves on Resident 1's hands as an intervention to either distract the resident from scratching, or to minimize the impact of such scratching; (3) there was neither an assessment of, or care plan for, the use of the intervention; and (4) Resident 1 was exposed to a risk of harm and/or harmed by the intervention. Because CMS made the required prima facie showing, the burden of persuasion is upon Petitioner to show that it was not deficient or that it has an affirmative defense. Petitioner simply cannot show that the intervention of placing gloves on the resident's hands was a safe and reasonable intervention ⁽⁷⁾ absent evidence of proper assessment and care planning as defined by the regulation. ⁽⁸⁾ Resident 1 suffered from senile dementia. CMS Ex. 8, at 15, 28. As of September 10, 2002 she was assessed as having severely-impaired decision-making skills and as totally dependent upon staff for all activities of daily living. Id. at 14, 38, 40, 45, 46. She was assessed as being unable to recognize and make her needs known. Id. at 18, 20, 38. She was assessed as having poor safety awareness. Id. at 46. She had trouble swallowing, or dysphagia, and was fed by a tube. Id. at 42, 49. Nurse's notes for the period August 4 through September 30, 2002 show chronic itching and scratching behavior and the use of medications including Atarax and Benadryl. Id. at 29-33. A nurse's note from September 3, 2002 shows that Resident 1 had pulled on her feeding tube. Id. at 60. A nurse's note from September 18, 2002 indicates that a nurse attempted to put gloves on the resident, but that attempt was unsuccessful. Id. at 67. Testimony of one of the nurses who cared for Resident 1 was that the use of gloves on Resident 1 was known and discussed among staff, and gloves were actually applied for one to two months. Tr. at 304-05. A nurse's note from September 28, 2002 shows that Resident 1 pulled out her urinary catheter with the balloon inflated. CMS Ex. 8, at 72. She pulled out her catheter again on September 30, 2002 and again on October 1, 2002. Id. Nurse's notes from August 24, 2002 through October 1, 2002 show that the resident had a chronic problem with scratching and removing a dressing from a left hip wound, and notes from later in the period actually characterize the resident as digging in the wound until it bled. Id. at 52-72. Hospice progress notes provided by Petitioner show that there were attempts to place gloves on the resident's hands, but that the resident removed those gloves. P. Ex. 1; Tr. at 277. Based upon these facts, I conclude that had Petitioner properly assessed and care planned for Resident 1, it would not have been reasonable to conclude that application of gloves to the resident's hands - gloves that the resident might easily remove and place in her mouth - was a safe intervention. Further, based upon the facts, I conclude that had Petitioner properly assessed and care planned for Resident 1, it would not have been reasonable for Petitioner to conclude that the application of gloves to the resident's hands was an effective intervention, or that the risk associated with the intervention was outweighed by any therapeutic benefit for Resident 1. Petitioner neglected to conduct a proper assessment or develop a proper care plan related to the intervention, in violation of 42 C.F.R. � 483.20.

4. CMS has failed to make a prima facie showing that Petitioner violated 42 C.F.R. � 483.75 (Tag F 490).

Title 42 C.F.R. � 483.75 provides:

A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

The surveyor alleges that this requirement was violated by: (1) "failing to ensure that licensed/certified staff administered care in accordance with accepted professional standard of practice for use of latex gloves for prevention of scratching and digging behavior;" (2) "not obtaining physician's orders for medical or other types of restraints prior to application;" and (3) failing to ensure that "all medical interventions/restraints were assessed by the facility for use, fit, or safety of the resident, that a care plan was developed to indicate when the device was applied, and how the facility would monitor the gloves when they were on the resident." CMS Ex. 4, at 14. For the reasons already discussed, the alleged violation is not supported by the first two grounds. However, the third ground is supported by my finding of a violation of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281).

CMS argues that it has made a prima facie showing of a violation of 42 C.F.R. � 483.75 (Tag F 490). CMS Brief at 9. Certainly, the Board has upheld violations of 42 C.F.R. � 483.75 based upon findings of other independent deficiencies. See Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 16 (2002) ("the existence of independent deficiencies may constitute a prima facie case that a facility has not been administered efficiently or effectively as required by section 483.75."); Asbury Center at Johnson City, DAB No. 1815 (2002); Western Care Management Corp., d/b/a/ Rehab Specialties Inn, DAB No. 1921 (2004). However, it is not enough that there be other independent violations. The evidence must also show that the facility is not managed effectively and efficiently for the benefit of the residents. See Beechwood Sanitarium, DAB No. 1906 (2004).

CMS cites no evidence of ineffective or inefficient management other than the facts related to the death of Resident 1. The facts cited are specifically limited to a single resident, show that an intervention was attempted, but then stopped because it was obviously ineffective, and a single CNA attempted to apply gloves to Resident 1 on one additional occasion and Resident 1 died as a result. ⁽⁹⁾ No other residents were specifically identified as at risk, and no problems with management were identified during daily monitoring visits of approximately two hours each between October 2 and 9, 2002. Tr. at 130-31, 138-39. Given the facts, I do not find that CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.75 (Tag F 490). ⁽¹⁰⁾

5. A total CMP of $70,000 is not reasonable in this case, but a total CMP of $7,000 is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making process. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly-independent choice of remedies without regard to CMS's discretion. Community Nursing Home, DAB No. 1807, at 22, et seq.; CarePlex, DAB No. 1638, at 8.

CMS determined that the facts of this case presented immediate jeopardy to Resident 1 and other residents. CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). Given the facts of this case, I cannot find that the CMS determination of immediate jeopardy for Resident 1 was clearly erroneous. Resident 1 was a demented resident who had behaviors that without question caused her physical pain, such as pulling out her catheters, pulling on her feeding tube, and digging in her wound. Tr. at 267. Resident 1 had poor safety awareness and poor judgment, and was totally dependent upon staff for her care. Giving Resident 1 a plastic or rubber glove differed little from giving the same to an infant or toddler. The presence of immediate jeopardy, even as to one resident, permits imposition of a CMP in the highest range of authorized CMPs - $3,050 per day to $10,000 per day. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2).

CMS proposes the highest possible CMP of $10,000 per day for the seven-day period from October 2 through 8, 2002, a total CMP of $70,000. Tr. at 41. It is apparent that the Secretary intended the highest possible CMP to be imposed in the most egregious cases, with lesser amounts to be imposed in less egregious cases. This case does not represent one of the most egregious, and it is apparent that the CMP proposed by CMS is not reasonable.

I have considered the remedial purpose to be served and the factors specified by 42 C.F.R. �� 488.404 and 488.438(f). I have been presented no evidence showing that Petitioner had a history of noncompliance. I have been presented no evidence from which I might assess Petitioner's ability to pay and Petitioner has not argued an inability to pay. CMS argues that a significant CMP is warranted due to the fact Resident 1 died and there were serious problems in the facility's administration. CMS Brief at 21-22. I have concluded that CMS has failed to make a prima facie showing of "serious problems" with this Petitioner's administration. I also concluded that CMS failed to show that there was any improper use of restraints in this case. Finally, I note that the surveyor cited all deficiencies as being at a scope and severity level of "J," which means an "isolated occurrence," rather than a "pattern of" or "widespread" occurrences. CMS Ex. 4.

The regulations require that I consider Petitioner's culpability. Culpability is defined by 42 C.F.R. � 488.438(f)(4) to include "but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety." Application of the easily-removable "examination style" gloves to Resident 1's hands, given her demented state, poor judgment and other impairments, presented a safety hazard to her. If Petitioner had appropriately assessed Resident 1 and the intervention of using the gloves, the risk to Petitioner may have become apparent and Petitioner might have elected to use the socks or mitts originally care planned for Resident 1. CMS Ex. 17, at 1. Petitioner neglected ⁽¹¹⁾ to do proper assessment and care planning for Resident 1 with regard to the use of the gloves, and Resident 1 was harmed. Petitioner was culpable.

Petitioner was culpable, and this was a serious deficiency which resulted in or contributed to the death of a resident. However, I do not find the violation to be so egregious as to deserve the maximum penalty. It is also agreed by the parties that Petitioner remedied the deficiency to the satisfaction of CMS. Thus, the remedial purpose of imposing a CMP has been achieved. The evidence presented shows that Petitioner did care for Resident 1. There is evidence of assessment, care planning, and treatment for Resident 1. The evidence does not reflect any evidence of intentional or negligent abuse or maltreatment of Resident 1. The single failure of Petitioner cited as the basis for all of the alleged deficiencies relates to the use of the gloves. Nevertheless, a significant remedy is warranted by the fact that any failure to properly assess and care plan can have serious consequences for a resident and, in this case, that failure caused or contributed to death of the resident. Accordingly, I conclude that a $7,000 per day CMP is reasonable.

The remaining issue has to do with the duration of the immediate jeopardy deficiency and a reasonable period to which the $7,000 per day CMP shall be applied. CMS alleged that the deficiency continued from October 2 through October 8, 2002, and that the CMP should be imposed for those days. CMS cites no other rationale for imposing a CMP for a period of seven days, other than its belief that the deficiency was a continuing one for the entire period. CMS Brief at 21-23. Allison Onufer Hillhouse, a health facility evaluator supervisor for the state agency, testified that no other residents were specifically identified as at risk and no problems with management or use of gloves were identified during daily monitoring visits of approximately two hours each between October 2 and 9, 2002. Tr. at 130-31, 138-39. Ms. Hillhouse further testified on cross-examination as follows:

Q: (By Counsel for Petitioner): On the resurvey on the 9^th of October, when it was determined that there were no continuing deficiencies, the Agency determined that the date of correction was that date, the date of the survey. Correct?

A: (Ms. Hillhouse): Yes, ma'am.

Q: Was there any attempt to ascertain whether the alleged deficiency had been corrected prior to that date, or do you automatically use the date of survey as the date of correction?

A: In general, we use the date of survey. For immediate jeopardy, we're required to do an on-site visit to determine correction.

Q: But between the 2^nd and the 10^th, you have no evidence or information which would suggest that any resident at Heron Pointe, or any circumstances that existed there, cause immediate jeopardy to an resident do you?

A: We have no information that any harm had taken place between the 2^nd and the 9^th, when we did our follow-up.

Q: Nor do you have any information that any resident was at any risk, in any immediate jeopardy do you?

A: No, ma'am.

Tr. at 137-38. Ms. Hillhouse agreed that Petitioner alleged in its plan of correction that the plan had been implemented and it was in substantial compliance as of October 2, 2002. Id. at 141.

Petitioner's Administrator, Scott Howard Smith, testified that when the first surveyor, Cecil Deas, advised him on October 1, 2002 that there was probably immediate jeopardy, he and staff immediately reviewed all residents to ensure no gloves were in use for any reason, they did in-service training for staff covering the facility restraint policy, and the abuse and neglect policy. The charts of all residents with restraints were reviewed to ensure they were appropriate and supported by orders. Mr. Smith testified that all of his actions were completed by October 2, 2002. Tr. at 161-62. Mr. Smith's testimony is unrebutted and, in fact, appears to be supported by the testimony of Ms. Hillhouse.

A per day CMP may be imposed "for the number of days of noncompliance until the date the facility achieves substantial compliance, or, if applicable, the date of termination. . . ." 42 C.F.R. � 488.440(b). Pursuant to the regulation, "(i)f an on-site revisit is necessary to confirm substantial compliance and the provider can supply documentation acceptable to CMS or the state agency that substantial compliance was achieved on a date preceding the revisit, penalties imposed on a per day basis only accrue until that date of correction for which there is written credible evidence." 42 C.F.R. � 488.440(h)(1). In this case, the testimony of Ms. Hillhouse indicates that the date of the revisit survey was automatically used as the date on which substantial compliance was achieved. I have no evidence that the state agency or CMS made a determination based upon the plan of correction or other evidence that Petitioner may have achieved substantial compliance prior to the date of the revisit survey. My review is de novo anyway. The unrebutted evidence is that all corrective actions required to bring Petitioner into substantial compliance, corrective actions ultimately accepted as adequate by CMS and the state, were actually completed by October 2, 2002. Accordingly, I conclude that Petitioner achieved substantial compliance as of October 2, 2002 and there was only one day of immediate jeopardy, October 1, 2002.

III. Conclusion

For the foregoing reasons, I conclude that on October 1, 2002, Petitioner was in violation of 42 C.F.R. � 483.20 with respect to Resident 1, and that violation posed immediate jeopardy for Resident 1. Petitioner achieved substantial compliance effective October 2, 2002. A one-day CMP of $7,000 is reasonable in this case.

Keith W. Sickendick

Administrative Law Judge

1. All references are to the revision of the Code of Federal Regulations (C.F.R.) in effect at the time of the surveys, unless otherwise indicated.

2. This is a "Tag" designation that refers to the part of the State Operations Manual (SOM), Appendix PP, "Survey Protocol for Long-Term Care Facilities," "Guidance to Surveyors," that pertains to the specific regulatory provision allegedly violated. The cited deficiencies are set forth in a Statement of Deficiency, Form 2567L (SOD) prepared by the state surveyors. Each deficiency includes a scope and severity (SS) level such as "SS=J." See, e.g., CMS Ex. 4, at 1 (left column). Scope and severity levels are used by CMS and a state agency when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM at section 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm, but has the 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 has the 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 deficiencies that constitute immediate jeopardy to resident health or safety. Letters A, D, G, and J indicate an isolated occurrence; letters B, E, H, and K indicate a pattern of occurrences; and letters C, F, I, and L indicate widespread occurrences. The matrix, which is based on 42 C.F.R. � 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. See SOM, section 7400E.

3. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. State of Indiana by the Indiana Department of Public Welfare v. Sullivan, 934 F.2d 853 (7^th Cir. 1991); Northwest Tissue Center v. Shalala, 1 F.3d 522 (7 ^th Cir. 1993). Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

4. See also, Act, sections 1819(c)(1)(a)(ii) (SNFs) and 1919(c)(1)(a)(ii) (NFs) which provide that a long-term care facility resident has a right to be free from "physical or mental abuse, corporal punishment, involuntary seclusion, . . . ."

5. Although the SOM instructs surveyors to use Tag F 224 for deficiencies concerning neglect (CMS Ex. 18, at 7 ), I have already explained that the SOM is an interpretative rule rather than a substantive rule.

6. I do not view it the task of an ALJ to determine whether a provider violated a provision of the SOM designated by a tag number. Rather, the ALJ determines whether or not, based upon the facts of a case, a provider was in violation of Medicare and Medicaid participation requirements establish by the Congress, by the Act, or by the Secretary through his regulations.

7. The regulations make no distinction between "nursing interventions" and other interventions.

8. I do not suggest that assessment and care planning are an absolute defense as there may remain questions regarding the adequacy of both the assessment and plan.

9. The parties agreed at the beginning of the hearing that the cause of death does not really matter in this case. Tr. at 46-47. Of course, I am not bound in any respect by that agreement. The preponderance of the evidence in this case is that Resident 1 died from asphyxiation due to a glove blocking her airway. CMS Exs. 15, 16. I do agree with the parties that that fact does not affect the deficiency finding.

10. CMS also argues that the facts of this case could also have been characterized as violations of 42 C.F.R. �� 483.25 (Tag F 309) and 483.25(h)(2) (Tag F 324). I have no doubt that is true, as skillful lawyers can do much with words. However, allegations of additional deficiencies should have been done well in advance of hearing consistent with the CMS authority to reopen and revise its determinations under 42 C.F.R. � 498.30 et al., to avoid any potential violation of Petitioner's rights to notice and hearing and to avoid waste of judicial resources.

11. "(F)ailure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. � 488.301