SUBJECT:

Teresian House Nursing Home Company, Inc.,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration or HCFA) ⁽¹⁾ to impose against Teresian House Nursing Home Company, Inc. (Petitioner or Facility) the remedy of denial of payment for new admissions (DPNA).

I. Applicable law

Petitioner is a long-term care facility participating in the federal Medicare program as a skilled nursing facility (SNF) and in the State Medicaid program as a nursing facility (NF).

Medicare, a federally-subsidized health insurance program for the elderly and disabled, was established under Title XVIII of the Social Security Act (Act). Medicare provides reimbursement for certain services rendered by providers, such as a SNF like Petitioner, who participate in the Medicare program under "provider agreements" with the United States Department of Health and Human Services (DHHS). In order to enter into such an agreement, SNFs must meet certain requirements imposed by applicable statute and regulations. Act, section 1819 (42 U.S.C. § 1395i - 3); 42 C.F.R. Parts 483, 488, and 489. The requirements for participation in Medicare by SNFs are set forth at 42 C.F.R. Part 483. A SNF is subject to the survey, certification, and remedies provisions of 42 C.F.R. Part 488, and to the provisions governing provider agreements at 42 C.F.R. Part 489.

Title XIX of the Act provides for grants to states for medical assistance programs (Medicaid). Section 1903 of the Act permits federal financial participation in amounts expended as medical assistance at a rate set for each state by a formula at section 1905(b). The Act provides that medical assistance means payment of the costs of certain listed services, as well as "any other medical care . . . specified by the Secretary." Act, section 1905(a)(27).

The survey process is the means by which DHHS (through CMS) assesses providers' compliance with participation requirements. State survey agencies, under agreements with CMS, perform the surveys of SNFs and make recommendations to CMS as to whether such facilities meet federal requirements for Medicare and Medicaid participation. Act, section 1864(a); 42 C.F.R. §§ 488.10, 488.11, and 488.20. The results of these surveys are used by CMS as the basis for its decisions regarding a SNF's initial or continued participation in Medicare and Medicaid. CMS, not a state survey agency, makes the determination as to whether a facility is eligible to participate or remain in Medicare and Medicaid. Id.

The regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301.

The regulations define "noncompliance" as "any deficiency which causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301. A deficiency is "a SNF's . . . failure to meet a participation requirement. . . ." Id.

The regulations define "immediate jeopardy" as follows:

Immediate 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.

42 C.F.R. § 488.301.

Under Part 488, a state or CMS may impose a DPNA against a facility when the state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. § 488.406. A DPNA continues until either:

(1) The facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit; or

(2) CMS or the State terminates the provider agreement." 42 C.F.R. § 488.454(a);

see Act, section 1819(h)(3).

CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that the provider was not in substantial compliance with the participation requirements at issue. Once CMS has established a prima facie case, the provider has the ultimate burden of persuasion: to prevail, the provider must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirement at issue. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U. S. Dept. of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

Petitioner is a New York not-for-profit corporation located in Albany, New York. Petitioner is defined as a certified Skilled Nursing Facility under the Medicare program, and a certified Nursing Facility under the Medicaid program. Petitioner's Brief (P. Br. at 1.) In response to a complaint received regarding a resident not cited in the matter before me, an abbreviated survey was conducted on February 22, 2002 by the New York Department of Health (State survey agency or DOH). Petitioner's Exhibit (P. Ex.) 1, at 4 - 5. As a result of the abbreviated survey, Petitioner was cited for a G-level deficiency under F Tag 324 (42 C.F.R. § 493.25(h)(2)). Id. The Statement of Deficiencies (SOD) for the abbreviated survey cited Petitioner for failure to implement measures and revise the comprehensive care plan approaches for prevention of falls for one resident admitted with a history of falls. Id. at 4. The DOH sent a notice letter, dated February 22, 2002, which accompanied the February 22^nd SOD advised that "[t]he most serious deficiencies found during this survey were isolated deficiencies that constituted actual harm with potential for more than minimal harm that is not immediate jeopardy whereby significant corrections were required (G)." Id. at 1 (emphasis in original). During the abbreviated survey, in addition to focusing on the resident for whom the complaint was filed, the State survey agency also reviewed Petitioner's incident/accident reports for two other residents who experienced prior fall incidents. Id. at 4. The State survey agency commenced a standard survey on February 25, 2002, which was completed on March 5, 2002. CMS Exhibit (CMS Ex.) 5. During this survey, it was determined that Petitioner was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. By notice letter dated March 6, 2002, CMS advised Petitioner that immediate jeopardy to resident health and safety had been found based upon deficiencies under 42 C.F.R. § 483.13(a) (F Tag 221) and 42 C.F.R. § 483.25(h)(2) (F Tag 324). CMS Ex. 1. Other deficiencies were identified but are not before me in this matter. The March 6^th notice further advised of CMS's imposition of a DPNA as of March 8, 2002, and based upon the immediate jeopardy finding, Petitioner's Medicare provider agreement would be terminated on March 28, 2002 unless the immediate jeopardy was abated. Id. Petitioner submitted a plan of correction (POC) on March 7, 2002. CMS Ex. 12.

On March 19, 2002, the State survey agency conducted its first post-survey revisit. CMS Ex. 6. By letter dated March 26, 2002, Petitioner was notified of the finding of the abatement of the immediate jeopardy; however, deficiencies remained, but at a lesser level. Id. CMS further informed Petitioner of its acceptance of the State survey agency's recommendation to terminate Petitioner's provider agreement effective September 1, 2002, unless Petitioner achieved substantial compliance by September 1^st, and the continued imposition of the DPNA until Petitioner obtained substantial compliance. Id.

On May 9, 2002, a second revisit was conducted at which time Petitioner was found to have achieved substantial compliance. CMS Ex. 9. By notice dated June 6, 2002, CMS informed Petitioner of the rescission of the decision to terminate Petitioner's provider agreement, and effective May 4, 2002, the rescission of the imposed DPNA. CMS Ex. 10.

By letter dated May 8, 2002, Petitioner filed a request for hearing, and the case was assigned to me for hearing and decision. CMS filed, among other things, a motion to limit the scope of the hearing to the immediate jeopardy deficiencies, which was received by the Civil Remedies Division on February 19, 2003. On March 20, 2003, Petitioner filed a response to CMS's motion in which it withdrew its challenges to three of the 10 tags cited. After substantive prehearing case development, a hearing was scheduled to commence on this matter on February 9, 2004. By letters dated January 12, 2004 and January 16, 2004, the parties agreed that the case could be decided based on written arguments and documentary evidence, and that an in-person evidentiary hearing was unnecessary. The parties further agreed that, while numerous deficiencies were cited during the March 5, 2002 survey, only two of the deficiencies resulted in the imposition of the DPNA - F Tag 221 and F Tag 324. Therefore, the parties agreed that the scope of the case should be limited solely to these two deficiencies. During the briefing process, CMS submitted 146 proposed exhibits, and Petitioner submitted 81 proposed exhibits. Without objections, I admit CMS Exs. 1 - 146 and P. Exs. 1 - 81 into evidence. I base my decision in this case on the law, the evidence, and the parties' arguments.

III. Issue

The issue in this case is whether Petitioner was in substantial compliance with Medicare and Medicaid participation requirements during the March 5, 2002 survey. CMS chose to impose a DPNA remedy in this case. If Petitioner is found not to be in substantial compliance, I cannot review the choice of remedies imposed by CMS. 42 C.F.R. § 488.408(g).

IV. Findings and Discussion

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

A. Petitioner has waived its right to an in-person hearing and the parties have both agreed that the case can be decided upon written submissions.

Pursuant to 42 C.F.R. § 498.66, an affected party may waive its right to appear and present evidence at an in-person hearing. The waiver request must be in writing. After substantial prehearing case development, a hearing in this matter was scheduled to begin on February 9, 2004. Prior to the scheduled hearing, the parties agreed that this matter could be resolved based on the submission of written briefs and documentary evidence. By letter dated January 16, 2004, Petitioner waived its right to an in-person hearing. Petitioner advised that the case could be decided summarily, and concurred with a proposed briefing schedule that had been submitted by CMS.

The parties filed cross-motions for summary judgment, and both filed response briefs. While the parties both moved for summary judgment, they did not stipulate to undisputed facts in this case. To the contrary, the parties recognize factual disputes in their briefs and make their respective arguments accordingly. For example, Petitioner argues that Petitioner's medical records document that Petitioner was engaged in ongoing assessment and evaluation of the use of restraints relative to the residents at issue. CMS argues that the documentary evidence upon which Petitioner relies is not sufficient to constitute ongoing assessment and evaluation of use of restraints. As there are facts in dispute in this case, I find that summary judgment is not appropriate. I also find that the parties have adequately argued factual disputes with references to the documentary evidence of record to allow me to make determinations as to factual disputes. As the parties have fully argued factual disputes and both have maintained that the decision in this case does not require an in-person hearing, I have decided this matter based on the written submissions and arguments of the parties.

B. Petitioner was not in substantial compliance with the regulation found at 42 C.F.R. § 483.13(a) at the time of the March 5, 2002 survey.

Following the completion of the March 5, 2002 standard survey, Petitioner was cited a deficiency at the immediate jeopardy level, with respect to Resident Behavior and Facility Practices - Restraints, 42 C.F.R. § 483.13(a) (F Tag 221).

The regulation concerning Resident Behavior and Facility Practices - Restraints requires that:

(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); see CMS Ex. 5, at 5.

F Tag 221

The SOD cites specific findings of noncompliance with respect to F Tag 221 for Resident (R) Nos. 418, 86, 484, and 464. CMS Ex. 5, at 5 - 12. The specific allegations are that Petitioner failed to ensure that residents were assessed for the least restrictive restraint by the interdisciplinary team, and did not plan for or implement restraint reductions in current use for 10 of 30 residents reviewed during the standard survey. Id. at 7.

1. R418

According to the SOD, R418 was admitted into Petitioner's facility on November 17, 1999, diagnosed with dementia. CMS Ex. 5, at 7. The Minimum Data Set (MDS), dated January 2002, indicated daily use of full side rails on the bed. Id. The Restraint Necessity Flow Sheet, dated April 24, 2000, noted that R418's family requested the side rails, due to the resident's history of injurious falls. Id.

Between August and December of 2001, R418 experienced three falls from her bed, during the time the full bed rails were in use. The first incident occurred on August 18, 2001. CMS Ex. 5, at 7 - 8; CMS Ex. 17, at 1 - 5. The resident was found sitting on the floor of her room holding on to the side rails. CMS Ex. 17, at 1, 3. The resident did not sustain any injuries. CMS Ex. 5, at 7. On August 31, 2001, R418 was again found sitting on the floor of her room. CMS Ex. 5, at 8; CMS Ex. 18, at 1. Unlike the first episode, R418 sustained a laceration near her left eye which resulted in facial swelling and bruising, as well as a laceration to her left hand which resulted in exposure of tendon. CMS Ex. 5, at 8; CMS Ex. 18, at 2. The Incident Report indicates that the resident sustained these injuries as a result of climbing over the side rails. CMS Ex. 18, at 3. On December 15, 2001, R418 was found in the doorway of her room sitting on the floor leaning against the door frame. CMS Ex. 5, at 8; CMS Ex. 19, at 1. The Incident Report noted that a "copious" amount of blood was noticed on the bridge of her nose. CMS Ex. 19, at 1. R418 was transferred to the emergency room where she received sutures for the laceration. CMS Ex. 5, at 8. The Supervisory Incident Investigation Form, dated December 15, 2001, noted that the staff was advised to monitor the resident closely at all times. CMS Ex. 19, at 2.

Petitioner argues that the use of the full side rails was in response to R418's diagnosed dementia, coupled with continued attempts to walk about independently. P. Br. at 23. Petitioner further contends that the continuous use of elevated side rails was ordered by the resident's attending physician upon admission, and that the order was renewed on June 29 and August 24, 2001. Id. (citing P. Exs. 18, 19, and 20). Petitioner also argues that the use of the side rails, as well as the benefits and risks of use, was discussed with and supported by interested members of R418's family. Id. In its brief, Petitioner merely outlines the resident's medical records which indicate that the care plan documents side rail use and problems with the resident trying to get out of bed without assistance. Petitioner argues that side rails for this resident was continuously care planned. Lastly, Petitioner maintains that the use of the side rails was consistent with a DOH Decision Tree, issued by DOH, which addressed the use of side rails in long-term care facilities. P.

Br. at 23; see also CMS Ex. 16. Petitioner argues that, in accordance with the Decision Tree, side rail use is acceptable when they are requested by, among others, a health care agent or interested family member, and the resident's care team deem use appropriate. P. Br. at 23 (citing P. Ex. 16).

CMS responds that, after the occurrence of the three falls at issue, Petitioner did not make adjustments to R418's restraint plan of care. CMS Br. at 9. CMS further argues that, even though Petitioner asserts that the use of side rails was discussed with the resident's family, the family had not been updated regarding the benefits and risks of the use of side rails since April 28, 2000, before the resident suffered the three falls at issue. CMS Reply at 3. CMS also contends that Petitioner's argument relating to the monthly evaluation and assessments as to the use of side rails is without support from the medical record. Finally, CMS asserts that Petitioner's claims regarding application of the Decision Tree are baseless. CMS argues that the Decision Tree requires that any request for use of side rails must be reviewed and approved as appropriate by the resident's interdisciplinary care team. CMS argues that there is no evidence of any such determination by the interdisciplinary care team regarding R418. Id.

I find CMS's arguments to be compelling. Petitioner does not dispute that the falls occurred as alleged by CMS. Petitioner does not present rebuttal evidence which refutes CMS's assertions relative to the falls. Instead, Petitioner presents an outline of the resident's medical records designed to show that the care plan documents the use of side rails and R418's continuous attempts to independently get out of bed. While Petitioner argues that it was performing monthly evaluation and assessments relative to the use of side rails, the purported assessments do not even document the occurrence of the falls at issue. Nor do the records indicate that the falls were a consideration in determining whether the use of side rails was adequate and the least restrictive restraint. The record upon which Petitioner relies consists of brief notations in the "Outcome" column of R418's care plan. A mere notation in the "Outcome" column of a care plan does not suffice to constitute an evaluation and assessment relative to the use of restraints in the care of R418. In addition, Petitioner contends that the use of side rails was discussed with the resident's family members. However, the records indicate that the family had not been updated as to the benefits and risks, in connection with the side rails, since April 28, 2000. There are no records which indicate that the use of side rails was discussed with family members after R418 sustained three falls, two of which resulted in actual injury to R418. See CMS Ex. 21, at 1. CMS has established that Petitioner was not in compliance with the requirements of participation relative to R418. The burden, therefore, is on Petitioner to rebut the prima facie case by showing that, more likely than not, it was in substantial compliance or that it can establish an affirmative defense. Petitioner has not met that burden as to R418.

2. R86

R86 was admitted to the facility on June 2, 1999. CMS Ex. 5, at 8. The resident was diagnosed with Parkinson's disease, dementia, and hypertension. Id. The SOD indicates that the resident's MDSs, dated October 26, 2001 and January 24, 2002, indicated that the resident had severe cognitive impairment, along with impairment of short and long-term memory. Id. The MDSs also note the resident to have impaired ability to understand and be understood. Id. at 8 - 9. The October 2001 and January 2002 MDSs note that restraints were not in use with R86. Id. at 9.

The resident's medical chart includes only one Restraint Necessity Flow Sheet dated May 1, 2000, which notes: 1) the use of a Geri-chair as a restraint; 2) the desire of the resident's family to use the restraint; 3) R86's hip fracture repair, and use of the Geri-chair as a means to keep the resident from ambulating; and 4) the restraint being identified as "essential" by Physical/Occupational Therapy. CMS Ex. 5, at 8 - 9; CMS Ex. 28.

The medical records indicate that R86 sustained three falls, between November 7, 2001 and January 26, 2002, while attempting to climb out of the Geri-chair by going over the locked lap tray. CMS Ex. 5, at 8 - 9; CMS Ex. 28. In the November 7, 2001 incident, the record indicates that a nurse reportedly heard a thud, and turned to find R86 on the floor, lying on his right side. The resident had been sitting in a Geri-chair just prior to the incident. R86 sustained no injuries at that time. CMS Ex. 34, at 1 - 2; CMS Ex. 5, at 9. The next incident is recorded to have taken place on November 10, 2001, with R86 initially sitting in a Geri-chair in the day room. As staff conducted rounds, one staff member reported hearing a "thud," and checked the day room where R86 was found on the floor next to the Geri-chair. The resident sustained injuries to his right elbow. After dressing the resident's injury, the staff member walked him around the unit, then returned R86 to the Geri-chair. CMS Ex. 35, at 1; CMS Ex. 5, at 9; CMS Ex. 29, at 7. The third occurrence took place on January 26, 2002, while R86 was in the TV room. The certified nurse's aide (CNA) heard a crash, and when the CNA investigated, found R86 sitting on the floor beside his lounge chair. The tray table was up at that time. CMS Ex. 38, at 1; CMS Ex. 5, at 9. The medical records document that R86 will attempt to climb out of the chair when he is agitated. See CMS Ex. 38, at 3; CMS Ex. 35, at 3; CMS Ex. 32, at 2; CMS Ex. 29, at 6, 9; CMS Ex. 30, at 1, 2, 3, 6, 7, 9, 10, 12.

R86's care plan, dated May 9, 2001, indicates the use of the Geri-chair to prevent R86 from ambulating and reinjuring his recently fractured right hip. CMS Ex. 26, at 4. Subsequent documentation indicates the continued use of the Geri-chair, with the tray, for safety with no injuries noted. Id.

CMS asserts that, based on repeated documentation of falls, Petitioner should have considered, and implemented, the use of other restraint devices. CMS Br. at 15. CMS argues that R86 was identified as "at risk for falls," and, thus, use of the Geri-chair was implemented as a restraint device. Id. CMS further argues that, even though the nurse's notes indicate that several attempts were made by R86 to slide under the table tray, or that "thuds" were heard leading to the discovery of the resident on the floor, there is nothing in the record to indicate that Petitioner investigated these incidents. Id. CMS concludes by stating that, in light of these incidents, R86's May 2001 care plan was not revised or updated to include amended safety precautions. Id.

Petitioner counter-argues that the nursing staff conducted monthly evaluations, which are documented in the resident's care plan under the "Outcome" category. P. Reply at 8. According to Petitioner, the notations are indicative of ongoing evaluation and assessments of restraint device use with this resident. Id.

Again, Petitioner does not dispute the incidents in which the resident had fallen from his chair. Petitioner argues that monthly review and assessments regarding the use of the Geri-chair were conducted, and, thus, the regulatory requirements have been satisfied. P. Br. at 25 - 26. In its responsive briefs, Petitioner does not address the falls noted in the record. Nor does Petitioner elaborate on the "Outcome" notations it attempts to raise as an affirmative defense. In fact, the notations in the "Outcome" portion of the care plan which Petitioner claims to be ongoing evaluation and assessments do not even mention the resident's falls. CMS Ex. 26, at 4.

I find that CMS has established a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(a) as to R86. Petitioner has not established that it was in substantial compliance with participation requirements. Petitioner has not provided any evidence to support its position that it attempted to use a less restrictive restraining device. Furthermore, there is little evidence presented to establish that Petitioner evaluated the falls or even considered a less restrictive device. Continued use of the Geri-chair for this resident should have been reassessed in light of the numerous falls experienced by R86. It is well settled that it is the responsibility of a facility to evaluate the extent of a resident's individual needs, and then make assessments for use of the least restrictive device that would adequately address those needs. See, e.g., Lakeland Continuing Care Center, DAB CR683 (2000); Golden State Manor Nursing and Rehabilitation Center, DAB CR412 (1996); Lakeridge Villa Health Care Center, DAB CR1231 (2004); Cross Creek Health Care Center, DAB CR504 (1997). The Geri-chair had been used for this resident since May 9, 2000, in response to the family's request for its use to prevent injury to the resident's hip. In spite of the family's specific request, Petitioner should have reevaluated the situation and circumstances, and formulated alternative, less restrictive means of protecting R86 from injury.

3. R484

R484 was admitted to the facility on January 15, 2002. CMS Ex. 5, at 10. At the time of admission, the resident was in a weakened physical state due to recent surgery for a bowel obstruction. Id. R484's initial Resident Assessment Profile (RAP) identified the resident as, among other things at risk for falls. P. Ex. 70. The resident's initial care plan dated February 4, 2002, noted her to be at risk for falls and noted the use of side rails to prevent falls with injuries. P. Ex. 34, at 2, 3.

Nursing notes and incident reports show that, between February 14, 2002 and February 21, 2002 ⁽²⁾, R484 attempted to climb over the side rails of her bed on several occasions. CMS Ex. 5, at 10; CMS Exs. 42 - 45. On February 25, 2002, the resident's family was contacted by the facility's nursing staff to request authorization to implement the use of a bed alarm, in addition to the continued use of the full bed rails. CMS Ex. 5, at 10; CMS Ex. 42, at 21. The resident was place on 15-minute-interval watches, to ensure her safety from falls, until the installation of the bed alarm on February 26, 2002. CMS Ex. 42, at 22.

CMS argues that the record does not reflect an attempt by Petitioner to implement a less restrictive restraint device, despite the fact that nursing notes indicate that R484 made numerous attempts to climb over the side rails of her bed between February 14^th and 21^st. CMS Br. at 10. CMS further contends that, although a bed alarm was ordered and put into use as of February 26^th, Petitioner continued to use the side rails which, clearly, were a danger to the resident. Id. at 11. CMS notes that there is no evidence in the record to indicate that Petitioner formally implemented frequent monitoring of the resident, aside from the period during which the bed alarm was being ordered and installed. Id.

Petitioner contends that R484's initial care plan addressed the use of side rails in an effort to prevent falls with injuries. P. Br. at 27. Further, Petitioner argues that: 1) not only was the use of side rails addressed in the care plan, the family was consulted prior to use; and 2) use of the side rails was consistent with DOH policy. Petitioner asserts that CMS did not prove that the use of the side rails was not a medical necessity, used for discipline, or used for the staff's convenience. Id.

CMS does not dispute the purpose for use of the side rails. CMS does note that Petitioner does not contest the fact that R484 attempted to climb over the bed rails on several occasions. CMS maintains that, in light of the fact that R484 had attempted to climb over the side rails, Petitioner should have implemented a less restrictive and more appropriate restraint. I find CMS's argument to be convincing. While Petitioner did implement the use of the bed alarm in response to the resident's repeated attempts to climb over the bed rails, Petitioner did not cease the use of the bed rails and consider, in the alternative, use of a less restrictive, and more effective, means of restraint. Petitioner's evidence and arguments did not establish that it was in substantial compliance with the requirements of 42 C.F.R. § 483.13(a) as to R484.

4. R464

R464 was admitted to the facility on September 8, 2000. Upon admission, the resident was diagnosed with dementia. CMS Ex. 5, at 11; CMS Ex. 46, at 1. The SOD indicates that the MDS, dated January 29, 2002, noted that the resident suffered from long and short-term memory impairment, and was moderately impaired as to decision-making capability. Id. On January 29, 2000, the resident's attending physician ordered the use of half side rails pursuant to a request from the resident. P. Ex. 38. R484's care plan, dated January 26, 2001, addressed the use of half side rails as a positioning device. CMS Ex. 51, at 5. The Restraint Necessity Flow Sheet, dated January 26, 2001, denotes the reason for the restraint use is for a feeling of security and to prevent falls from bed. CMS Ex. 5, at 11; CMS Ex. 49.

The nursing notes indicate that R464 experienced numerous falls from his bed. CMS Ex. 48. The SOD documents that, between January 22, 2002 [sic] and February 24, 2002 ⁽³⁾, R464 experienced three falls from his bed. The first incident occurred on January 27, 2002. At the time, R464 was found on the floor, at 3:05 a.m., with his arm wedged between the side rail and the bed frame. CMS Ex. 5, at 11; CMS Ex. 57, at 1. On February 11, 2002, the resident was found, at 4:20 a.m., sitting on the floor with his left arm caught in the side rail. CMS Ex. 5, at 11; CMS Ex. 48, at 18; CMS Ex. 58. On February 24, 2002, R464 was found sliding out of his bed with his left-side rib cage caught on the side rail. CMS Ex. 5, at 11; CMS Ex. 60, at 1. Redness to the injured area was documented. CMS Ex. 60, at 1.

Petitioner asserts that the side rails were being used as a "positioning" device, not as a restraint, in accordance with the resident's specific request. P. Br. at 27. Petitioner argues in the alternative that, even if it is asserted that the bed rails constituted a restraint, Petitioner would be in compliance with participation requirements. Petitioner maintains that the bed rails were ordered by the resident's physician and the nursing staff assessed and evaluated, on a monthly basis, the use of the half side rails. Id.

CMS argues that the Restraint Necessity Flow Sheet specifically indicates that the partial side rails were being used for security and fall prevention, and not as an assistive device. CMS Br. at 11. Thus, CMS argues, Petitioner should have taken steps to reevaluate the effectiveness and use of the bed rails with this resident, because of the numerous falls the resident sustained in which he became entangled in the bed rails.

CMS further maintains that Petitioner's alternate theory that even if the bed rails are deemed a "restraint" mechanism, they were: 1) requested by the resident; 2) ordered by the attending physician; and 3) care planned and assessed on a monthly basis, is irrelevant. CMS Br. at 11. CMS concludes that, contrary to Petitioner's contentions, the fact remains that, in spite of R464's numerous falls and entanglement in the bed rails, Petitioner did not reassess the use of side rails with this resident, and failed to implement a restraint reduction plan which would protect him from bodily entanglements in the rails. Id. at 7.

CMS has met its burden of showing Petitioner's substantial noncompliance with participation requirements as to this resident. The record shows that Petitioner did not conduct a reassessment, or plan to reduce or discontinue, the use of the side rails. In that the side rails posed an ongoing danger to the resident, Petitioner should have taken steps to reevaluate the effectiveness and use of the side rails with this resident, despite a specific request from the resident for the side rails, and the order by the attending physician.

C. Petitioner's argument, that the State survey agency failed to comply with State Operations Manual (SOM) survey procedures thus invalidating its findings, is without merit.

A standard survey was commenced on February 25, 2002, and was completed on March 5, 2002. Petitioner was cited with a deficiency relating to Quality of Care - Accidents, 42 C.F.R. § 483.25(h)(2) (F Tag 324), which requires that:

(h) Accidents. The facility must ensure that -

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. § 483.25(h)(2); See CMS Ex. 5, at 20.

F Tag 324

The SOD cites specific findings of noncompliance with respect to F Tag 324 as to Residents 418, 422, 582, 56, 86, 464, and 484. CMS Ex. 5, at 22 - 29. The specific allegations state that Petitioner failed to provide a system that developed and implemented interventions for residents at risk for falls. Id. The SOD further states that Petitioner failed to conduct monitoring, supervision, revisions to care plans, or thorough investigation of accidents and incidents to prevent recurrence. Id. The SOD indicates that Petitioner's failure to provide the aforementioned responses resulted in substandard quality of care with actual harm occurring to four residents (R56, R418, R422, and R582), and immediate jeopardy for seven residents (R56, R86, R418, R422, R464, R484, and R582). The SOD notes that three of the residents (R86, R464, and R484) did not experience actual harm, yet had potential for more than minimal harm. Id. ⁽⁴⁾

Petitioner does not dispute the events associated with the deficiency citation. Nor does Petitioner argue that it was in substantial compliance during the survey period. Instead, Petitioner attacks the State survey agency's compliance with the procedures set forth in the SOM. Specifically, Petitioner states that the Plan of Correction (POC) which it submitted responded to the alleged deficiency under 42 C.F.R. § 483.25(h)(2), and established a completion date of April 1, 2002. Petitioner argues that the State survey agency conducted the standard survey prior to the completion deadlines in Petitioner's POC. P. Br. at 34. Petitioner asserts that, if it had been given the opportunity to take the noted corrective measures, each resident would have been assessed for potential for risk of falls on the quarterly MDS, and the necessary changes would have been made to the residents' comprehensive care plans reflecting proactive interventions. Id. at 34 - 35. Petitioner contends that the State survey agency failed to comply with SOM procedures by conducting a standard survey in response to the deficiency cited in the February 22^nd abbreviated survey, prior to the completion dates set in the POC. Petitioner concluded that, based on its argument, the alleged deficiency under F Tag 324, as cited in the standard survey, must be overturned.

In support of its argument, Petitioner cites the SOM provision at section 7317 which states, in part:

A. The plan of correction serves as the facility's allegation of compliance in non-immediate jeopardy cases. The State can respond to the allegation of compliance in a number of ways.

1. Conduct revisit. - If the State determines that the plan of correction is acceptable, it will conduct a revisit near the time that the provider alleges all corrections have been made, but it will not be conducted prior to the latest date of correction. Surveyors should focus on what has occurred since correction dates; a determination of noncompliance is not based on problems which took place during the correction period.

See SOM, section 7317 ¶ A.1; P. Br. at Appendix A.

Petitioner also relies heavily on the Departmental Appeals Board's decision in Batavia Nursing and Convalescent Center, DAB No. 1904 (2004). Specifically, Petitioner contends that Batavia stands for the proposition that a survey agency may not conduct a standard survey during the correction period identified in an accepted POC. P. Br. at 32 - 35.

CMS concedes Petitioner's argument; that according to section 7317 of the SOM, a survey agency is precluded from conducting a follow-up survey as to deficiencies cited in a SOD upon acceptance of a facility's plan of correction. CMS Reply at 9. However, CMS continues, that is not applicable to the instant case. CMS argues that section 7317 of the SOM is applicable where the issue is a follow-up or revisit survey. In this case, a standard survey was conducted after the abbreviated survey. Id. at 9 - 10. CMS asserts that there is no SOM provision which would prevent the State survey agency from conducting a standard survey prior to the completion deadlines established in a POC which relates to deficiencies cited in an abbreviated survey. Id. at 10. CMS further contends that Petitioner's reliance on the decision in Batavia is misguided. CMS argues that the facts in Batavia are not analogous to those in the instant case. In Batavia, according to CMS, the issue dealt with a standard survey and a revisit; unlike this case which deals with an abbreviated survey and a standard survey. CMS concludes by asserting that, even if the State survey agency failed to follow SOM procedure to the letter, this would not invalidate sufficiently-documented deficiencies. CMS Reply at 11.

I concur with CMS's arguments on this point. Contrary to Petitioner's contentions, it was afforded an opportunity to correct deficiencies cited in both the February 22^nd abbreviated survey and the March 5^th standard survey. The revisit to the standard survey was not conducted until May 9, 2002, which was five days after the last date specified by Petitioner in the POC relating to the March 5^th survey. See CMS Ex. 5, at 29; CMS Ex. 9. Petitioner was not cited for deficiencies which took place during the correction period for the March 5^th standard survey. Petitioner was found to be in substantial compliance at the time of the May 9^th revisit. Furthermore, in the event the State survey agency failed to follow SOM procedure explicitly, and conducted a survey prior to the last completion date established in the POC, that error does not negate the validity of the deficiencies. 42 C.F.R. § 488.318(b) is clear in that:

(b) Inadequate survey performance does not -

(1) Relieve a SNF or NF of its obligation to meet all requirements for program participation; or

(2) Invalidate adequately documented deficiencies.

In addition, the Administrative Law Judge (ALJ) in Transitional Hospitals Corporation - Las Vegas (Transitional), DAB CR350 (1995), determined that a survey agency's failure to comply with SOM requirements does not give a petitioner any entitlements in program participation. In Transitional, the ALJ stated:

The SOM establishes guidelines to be followed by surveyors in the conduct of surveys. It does not constitute a statement by the Secretary which supersedes regulations. There is nothing to suggest that the Secretary has directed that the SOM be distributed to providers as an interpretation of the Act, or as a statement of their rights in the survey and certification process. In no respect does the SOM establish rights which inure to the benefits of the providers. Thus, the controlling law and policy here remains the requirement in the regulations that providers not be certified until they comply with all requirements for participation.

Transitional, DAB CR350, at 12.

Although the question before the ALJ in Transitional related to the issue of provider certification, his analysis is applicable with regard to the survey process as well. I agree with CMS's analysis of the law. The regulations state that inadequate survey performance, such as a survey agency's failure to follow procedures as delineated in CMS instruction manuals, does not invalidate adequately documented deficiencies. 42 C.F.R. § 488.318(b). Petitioner's argument on this point is without merit.

D. Petitioner was not in substantial compliance with the regulation found at 42 C.F.R. § 483.25(h)(2) at the time of the March 5, 2002 survey.

As noted in section IV C of this decision, the SOD addresses events involving 17 residents, and cites as examples seven of the 17 residents identified. See CMS Ex. 5, at 22 - 29. However, in the exercise of judicial discretion, I will address F Tag 324 as it relates to Residents 418 and 422 only.

1. R418

The facts relating to R418 are delineated in section IV. B, above. Two of the documented falls resulted in actual injury to the resident. CMS Ex. 5, at 22 - 23; CMS Exs. 14, 17 - 19.

The resident's MDS documents her as at risk for falls. CMS Exs. 13, 21. A review of R418's medical record indicates that, at the time of the August 18, 2001, August 31, 2001, and December 15, 2001 fall incidents, the resident was found on the floor with full side rails in place, as well as a bed alarm in use. CMS Ex. 14, 17 - 19.

CMS contends that Petitioner failed to adequately monitor or provide appropriate assistance devices such as lowering the bed and placing a mat on the floor. CMS Br. at 13. CMS argues that the resident's restraint care plan had not been revised in response to the incidents, and that Petitioner did not comply with its own internal policy regarding incident reporting. Id. Specifically, CMS asserts that the incident reports were not reviewed by the unit registered nurse, who is responsible for care planning, unless the incident happened on her shift. Id. CMS also argues that Petitioner did not incorporate the remedial measures, noted on the investigation form, into the resident's care plan. Id.

Petitioner does not present a rebuttal argument, or present any evidence to demonstrate that it was in substantial compliance with F Tag 324 as to R418. Instead, Petitioner focused its energy on the argument that this tag should be overturned due to the State survey agency's failure to follow survey procedure as established in the SOM. See Section IV, above. I find that CMS has proven its prima facie case that Petitioner was not in substantial compliance with participation requirements under 42 C.F.R. § 483.25(h)(2) as to R418, and Petitioner did not present any argument or evidence to establish it was in compliance with the participation requirements at issue in this case.

2. R422

According to the SOD, R422 was admitted to the facility on August 1, 2001. CMS Ex. 5, at 24. At the time of admission, the resident was diagnosed with dementia and a stroke. Id. The SOD notes that the resident's MDS, dated January 29, 2002, identified her as confused, having suffered numerous falls, being in slow functional decline, and at risk for falls. Id. A review of the medical records and incident reports notes 16 instances where the resident was found on the floor between November 4, 2001 and December 26, 2001. Id.; CMS Exs. 67 - 84. The remedial measures recommended on two of the incident reports (dated November 29, 2001 and December 26, 2001) identify the use of bed and chair alarms. CMS Ex. 5, at 24; CMS Ex. 74, at 3; CMS Ex. 78, at 3. R422's family was consulted, and the purchase of a chair alarm was authorized on December 4, 2001. Id. The resident had not received the requested alarm between December 4 and 26, 2001. Id. In addition, R422 had two documented incidents of falling on November 10, 2001. CMS Ex. 71; CMS Ex. 84, at 15. At that time, R422 sustained injury to her right ribs and an abrasion on her right lower calf. Id. Other incident reports note injuries such as a laceration to the head, which required six staples. CMS Ex. 84, at 21. The remedial intervention written on January 19, 2002, again, recommended the use of a bed alarm. CMS Ex. 80, at 3.

CMS argues that Petitioner did not thoroughly investigate these incidents, or conduct a cause analysis to prevent recurrences. CMS contends that Petitioner did not receive the family-approved chair alarm until December 26, 2001, and the bed alarm which was repeatedly recommended as a remedial intervention was never received. CMS Br. at 14.

Again, Petitioner offers no evidence or argument to rebut CMS's contention of noncompliance. As noted above, Petitioner elected to focus its argument, as to F Tag 324, on the State survey agency's failure to follow SOM procedure. I find that CMS has met its burden of proving a prima facie case as to this citation. Petitioner failed to take sufficient measures to prevent accidents, and, thus, did not meet the standard required by the regulations. Petitioner did not rebut CMS's prima facie case, nor did it establish that it was in substantial compliance as to 42 C.F.R. § 483.25(h)(2).

E. The regulations do not require that I determine whether the deficiencies cited at 42 C.F.R. § 483.13(a) and 483.25(h)(2) constituted immediate jeopardy to resident health and safety.

The regulations at 42 C.F.R. § 498.60(c) states:

Scope of review: Civil money penalty. In civil money penalty cases -

(1) The scope of review is as specified in § 488.438(e) of this chapter; and

(2) CMS's determination as to the level of noncompliance of an SNF or NF must be upheld unless it is clearly erroneous.

An analysis and determination of whether the level of noncompliance alleged by CMS is sustained is triggered by the imposition of a civil money penalty. The amount of a civil money penalty may be affected by a determination as to the level of noncompliance. CMS did not impose a civil money penalty in this case. The remedy imposed in this matter is a DPNA for the specific period from March 8, 2002 to May 4, 2002. The regulation relative to a DPNA does not require a determination as to the level of noncompliance. An analysis and determination as to the level of noncompliance for a DPNA remedy would in no way affect the amount or the period of time of the DPNA.

Thus, while both parties make arguments as to whether the cited deficiencies rise to the level of immediate jeopardy, such a determination is not required in this case.

V. Conclusion

For the reasons addressed above, I sustain CMS's determination and find that Petitioner was not in substantial compliance with participation requirements at 42 C.F.R. §§ 483.13(a) and 483.25(h)(2). I further sustain CMS's determination to impose a DPNA for the period from March 8, 2002 to May 4, 2002.

Alfonso J. Montano

Administrative Law Judge

1. Since "HCFA" was used to refer to the agency at the time that the actions at issue were taken, references from documents use the old acronym. However, for the sake of clarity, I will refer to the agency and any related documentation as "CMS."

2. The SOD indicates that this resident's attempts to climb over the side rail occurred between February 14 and 21, 2002. However, on review of the nurse's notes (CMS Ex. 42) and the related incident reports (CMS Exs. 43-45), the dates of the incidents at issue are between February 7 and 22, 2002.

3. The SOD records the first fall incident as occurring on January 22, 2002. However, review of CMS Ex. 57 (Report of Resident Incident) reflects that the date in question is January 27, 2002.

4. The SOD further indicates that six of the residents (R12, R218, R230, R366, R520, and R566) had no actual harm, yet had potential for more than minimal harm due to recurrent incidents. CMS Ex. 5 at 22-29.