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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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St. Clair Pines Health Care Center, Petitioner, |
DATE: May 31, 2006 | ||
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Centers for Medicare & Medicaid Services.
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Docket No.C-04-430
Decision No. CR1453 |
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| DECISION | |||
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DECISION I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a Civil Money Penalty (CMP) against St. Clair Pines Health Care Center (Petitioner) for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and Medicaid. The CMP is based on a finding of immediate jeopardy effective April 22, 2004 until April 23, 2004, when the jeopardy was abated, at the rate of $3,050 per day of noncompliance, and $50 per day effective April 23, 2004 through May 25, 2004. I. Background This case came before me pursuant to a request for hearing filed by Petitioner on June 30, 2004, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g), 498.40. I held a hearing in Birmingham, Alabama on July 26 and 27, 2005. On May 5, 2005, CMS informed Petitioner that it was imposing the following remedies pursuant to a survey completed on April 23, 2004:
CMS Exhibit (Ex.) 4. CMS proffered 48 exhibits identified as CMS Exs. 1-48. These exhibits were admitted into evidence without objection. Petitioner offered 23 exhibits identified as Petitioner Exhibits (P. Exs). 1-23. As a result of CMS objections Petitioner withdrew some exhibits in their entirety or portions of exhibits. Thus, the following were admitted as Petitioner's exhibits: P. Exs. 1-4; P. Ex. 5, with the exception of pages 6, 22-24, 34, 35, 37, and 44 (from a total of 47 pages); P. Ex. 6, page 2 only; P. Ex. 7, with the exception of pages 3, 4, and 46-56; P. Ex. 8; P. Ex. 10; P. Ex. 12, with the exception of pages 1, 3, 7, and 27; P. Exs. 13-18; P. Ex. 19, pages 1 and 2 only; and P. Exs. 20-23. Transcript (Tr.) 5-9. Both parties called expert witnesses: Norma Ann Metheny, Ph.D., R.N., FAAN, (2) testified on behalf of CMS; Richard E. May, M.D., the facility medical director, testified on behalf of Petitioner. Carolyn Cochran, Patricia Murphy, and Ann White testified as fact witnesses for CMS; and Mona Pilkington, Joyce Mobley, Murlene Rogers, Kimberly Clemmons, Steven Snyder, and Renee Parker testified as fact witnesses for Petitioner. Subsequent to the hearing, the parties submitted simultaneous post-hearing briefs (CMS Br. and P. Br.), as well as reply briefs (CMS Reply and P. Reply). Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that, from April 22, 2004, until April 23, 2004, Petitioner was not in substantial compliance at the immediate jeopardy level. I also find that Petitioner was not in substantial compliance at the less than immediate jeopardy from April 23, 2004 through May 25, 2004. Consequently, I conclude that CMS was authorized to impose a CMP against Petitioner in the amount of $3,050 for one day of noncompliance at the immediate jeopardy level, and $50 per day for the deficiencies at the less than immediate jeopardy level from April 23, 2004 through May 25, 2004. II. Applicable Law and Regulations Petitioner is considered a long term care facility under the Act and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory requirements for participation by a long term care facility are found at �� 1819 and 1919 of the Act and the implementing regulations are found at Title 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs and denial of payment for new admissions against a long term care facility for failure to comply substantially with participation requirements. Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long term care facility that is not complying substantially with federal participation requirements. Part 488 of 42 C.F.R. provides that facilities that participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. �� 488.10-488.28. The regulations contain special survey conditions for long term care facilities. 42 C.F.R. �� 488.300-488.335. Under Part 488, a State or CMS may impose a CMP against a long term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance and runs until the date substantial compliance is achieved or the provider agreement is terminated. The regulations define the term "substantial compliance" to mean:
42 C.F.R. � 488.301. The regulations specify that a civil money penalty that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of civil money penalties, 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 civil money penalties, 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). "Immediate jeopardy" is defined to mean:
42 C.F.R. � 488.301. In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered:
In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, No. 98-3789 (D.N.J. May 13, 1999). The Act and regulations make a hearing available before an Administrative Law Judge (ALJ) to a long term facility against whom CMS has determined to impose a CMP. Act � 1128A(c)(2), 42 C.F.R. �� 488.408(g); 498.3(b)(12), (13). The hearing before an Administrative Law Judge is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991). III. Issues A. Whether Petitioner was complying substantially with federal participation requirements on the dates CMS determined to impose a CMP. B. Whether CMS's determination of immediate jeopardy is clearly erroneous. C. Whether the amount of the penalty imposed by CMS is reasonable, if non-compliance is established. IV. Findings and Discussion The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding. In analyzing each finding, I first summarize the observations and allegations made by the State Agency surveyors and recorded in the Statement of Deficiencies (SOD) (CMS Exs. 1, 2). (4) My discussion of the parties' arguments and my rationale for concluding that the facility either complied or failed to comply with applicable participation requirements follows that summary.
The regulation associated with Tag F280, 42 C.F.R. � 483.20(k)(2), provides that the facility must develop a comprehensive care plan that is reviewed and revised by a team of qualified persons after each assessment. The regulation associated with Tag F322, 42 C.F.R. � 483.25(g)(2), requires that, based on a comprehensive assessment, a facility must ensure that a resident who is fed by a naso-gastric or gastrostomy tube receives the appropriate treatment and services to prevent aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and nasal-pharyngeal ulcers and to restore, if possible, normal eating skills. I discuss these two deficiencies together because the facts underlying the findings of noncompliance involve the same resident and the same issues regarding the manner in which the facility cared for the resident.
Based on medical record review, R6 received a Percutaneous Endoscopic Gastrostomy (PEG) Tube on an outpatient basis on January 12, 2004 due to advanced Alzheimer's with delusions. CMS Ex. 2, at 6-7. She was bedfast and was unable to sit, and described as requiring total care. Id. at 7. The care plan for potential complications of Gastrostomy tube and enteral nutrition dated January 12, 2004, provided for bed elevation from 30 to 45 degrees at all times, with an indication that the feeding tube be turned off when the bed needed to be lowered. Id. On February 15, 2004, R6 was admitted to the hospital with breathing difficulty and was assessed as suffering from aspiration pneumonia. She was readmitted to the facility on February 20, 2004. At that time, the facility added the diagnosis of pneumonia. Id. When the resident was readmitted on February 20, 2004, the facility failed to update the care plan to include interventions related to correct positioning necessary to prevent aspiration for a tube-fed resident. Id. at 7-8. The Resident Assessment Protocol for activities of daily living dated March 4, 2004, revealed that the resident was not ambulatory, required transfer by two staff from bed to chair, and needed repositioning every two hours. Id. at 8. On April 20, 2004, at 9:20 a.m., during the entrance tour of the survey completed on April 23, 2004, two surveyors observed R6 in bed with the head of the bed minimally elevated at approximately 15 degrees. The tube feeding was infusing continuously at 60cc per hour. Id. On April 21, 2004, at 11:48 a.m., R6 was observed in bed on her right side. The head of the bed was elevated 45 degrees, but R6 was not because she was positioned in the bend of the bed with her head approximately 12 inches from the top of the bed. Id. The side rails were up and completely covered with blue pads. Id. at 8-9. A spread was draped over both side rails, and the resident could not be seen from the door by the staff. Id. at 9. She was only visible from a close proximity to her bed. Id. R6 was observed in a similar position at 12:25 p.m. and at 2:15 p.m. The head of the bed continued to be elevated at 45 degrees, the resident continued to be positioned in the bend of the bed, and the spread was still draped over the side rails, concealing the resident from view of the staff from the doorway to her room. Id. On April 22, 2004, at 11:47 a.m., R6 was observed by the Administrator, the Director of Nursing, two surveyors and the charge nurse, lying on her side in the bend of the bed with her head approximately 12 inches from the top of the bed. Id. at 10. During an interview with the Restorative Nurse on April 22, 2004, at 1:30 p.m., she stated that, in response to the surveyor's comment that the bed was flat (about 10 to 15 degrees), she went to the nurse and told her that the bed was not as high as required. Id. During an interview on April 22, 2004, at 2:25 p.m., the Restorative CNA was asked if she was aware that the resident was able to scoot herself down in the bed. The CNA responded affirmatively, and stated that she had known the resident could scoot down in the bed for at least a month and probably much longer than that. Id.
Regarding the deficiency at Tag F280, Petitioner contends that when R6 returned to the facility on January 12, 2004, after she was taken to the hospital for insertion of a feeding tube, a care plan was implemented to address the potential complications associated with tube feeding. These interventions included:
Petitioner also maintains that it updated the care plan concerning the resident's impaired mobility and body positioning. P. Br at 6-8. Additionally, Petitioner contends that it conducted a comprehensive assessment of R6 upon her readmission to the facility on February 20, 2004, and reviewed and updated the care plan within the time-frames required by the regulations. Petitioner notes, however, that the facility is not required to update the care plan if the resident has not experienced a significant change in condition. P. Br. at 8. Inasmuch as the resident's pneumonia (that caused her hospitalization) had resolved, there was no significant change in condition, according to Petitioner. Id. at 9. Finally, Petitioner argues that CMS has developed new grounds in its post-hearing brief to justify a deficiency under Tag F280. P. Reply at 4. Thus, it is Petitioner's position that CMS cannot now assert that the facility failed to identify the fact that R6 was able to scoot down in the bed as a risk factor, did not timely assess that risk factor, nor revise the interdisciplinary care plan to correctly position the resident to reduce the risk of aspiration, inasmuch as this is a different theory than the one advanced in the Statement of Deficiencies and fails to constitute a deficiency pursuant to the regulation underlying Tag F280. Id. None of Petitioner's arguments are supported by the evidence of record. At the outset, I must note that CMS's charge that Petitioner failed to identify the fact that R6 was able to scoot down in bed and did not timely assess that risk nor revise the care plan to address correct positioning of the resident is not novel. The SOD clearly charges that, when R6 was readmitted to the facility on February 20, 2004, Petitioner failed to include interventions related to correct positioning to prevent aspiration for a resident receiving tube feeding. Specifically, the SOD indicates that on April 21 and 22, 2004, R6 was observed incorrectly positioned with her head in the bend of the bed, approximately 12 inches from the top of the bed. It was further noted that the resident was not properly positioned because of her proclivity to scoot down in the bed. Carolyn Cochran, one of the State Agency surveyors, testified that, although R6 had developed a tendency to scoot down in the bed, the facility did not assess the resident as cited in the SOD. Tr. at 100. No interventions were implemented to correct the situation, although the facility's staff was aware for at least a month that R6 was able to scoot down in the bed. CMS Ex. 2, at 10. Petitioner's argument that when the resident returned to the facility on January 12, 2004, after insertion of the feeding tube, it implemented measures to address potential risks associated with tube feeding is not relevant to its failure to update the care plan after she was readmitted on February 20, 2004, when she was diagnosed with aspiration pneumonia. Petitioner's additional contention that the facility was not required to update the care plan because the resident had not experienced a significant change in condition is also without merit. In this regard, Petitioner maintains that, inasmuch as the pneumonia that caused the resident's hospitalization had resolved, there was no significant change in condition. CMS did not charge Petitioner with a failure to care plan for aspiration pneumonia, but rather with a failure to update the care to implement interventions to address the resident's tendency to scoot down in the bed. Norma Ann Matheny, Ph.D., testified as an expert in the care of tube-fed residents and the risks associated with that manner of feeding. She testified that R6 was at high risk for aspiration pneumonia. (5) Tr. at 42. Thus, Dr. Matheny opined, R6 needed to have very strict precautions implemented to reduce the probability of aspiration. Id. One way to address this concern was through proper positioning. Id. at 42-46. It is evident that when R6 scooted down in the bed she was in a position that increased her vulnerability to aspiration. After R6 was readmitted to the facility on February 20, 2004, and the staff noted that she was scooting down in the bed, no action was taken to address the risks associated with that change in her condition as required by the regulations. 42 C.F.R. � 483.20(b)(2)(ii). The Restorative CNA acknowledged being aware of the resident's tendency for a month prior to the survey and the Director of Nursing (DON) had been aware for approximately two months. CMS Ex. 2, at 10; Tr. at 316. Interestingly, the DON testified that R6 was checked every two hours, yet she did not know how long it took for R6 to scoot down in the bed so as to require repositioning. (6) Additionally, she admitted that the resident was not assessed to determine how long it would take her to scoot down. Tr. at 338-39. In view of the foregoing, I find that CMS has established a prima facie case that Petitioner was not in substantial compliance regarding the citation at Tag F280. Petitioner has not overcome that showing by a preponderance of the evidence.
Petitioner argues that CMS's finding of noncompliance with respect to Tag F322 is factually wrong. P. Br. at 13. Petitioner characterizes CMS as having found that the facility failed to update the care plan to include interventions related to the correct positioning of the resident to minimize the risk of aspiration. Petitioner refers to CMS Ex. 2, at 14. From this premise, Petitioner argues that CMS's position is incorrect, inasmuch as the facility addressed the resident's positioning in not one or two care plans, but on three care plans. P. Br. at 13. The argument is ineffectual because the crux of the deficiency cited by CMS as to Tag F322 is not the failure to include interventions in the care plan, but the failure to put into practice the interventions described in the care plan. What CMS has charged here is that Petitioner failed to ensure that a resident who was fed by a feeding tube actually received the appropriate treatment and services to prevent aspiration, among other complications. Specifically, the SOD addresses three areas of concern that denote Petitioner's noncompliance. These include the failure to maintain proper bed elevation, the failure to properly position the resident, and the failure to properly monitor the resident. CMS Ex. 2, at 13-26. CMS contends that Petitioner failed to maintain proper bed elevation for R6. Dr. Matheny stated that R6 needed to have very strict precautions implemented to reduce the possibility of aspiration. Tr. at 42. Those precautions included elevating the head of the bed and making sure that the resident's body was aligned so that the upper torso was up rather than scrunched down in the bed. Id. The evidence of record shows that, on April 20, 2004, at 9:20 a.m., during the entrance tour of the survey completed on April 23, 2004, the surveyor observed R6 in bed with the head of the bed minimally elevated at approximately 15 degrees, while the tube feeding was infusing continuously at 60cc per hour. CMS Ex. 2, at 15. The care plan provided for head of bed elevation between 30 and 45 degrees. CMS Ex. 12, at 5. Ms. Cochran, the surveyor, testified that, on April 20, 2004, she noticed that the resident was improperly positioned because the head of the bed was almost flat. Tr. at 82. Ms. Cochran thought that the nurse who accompanied her would immediately correct the situation, inasmuch as the standard of nursing care requires elevating the resident's head during the administration of enteral tube feeding to reduce the risk of aspiration. Id. The nurse, however, was not even responsive to a suggestion by the surveyor that something might be wrong about the resident. Id. at 83. Thus, it was not until the surveyor informed the nurse that the head of the bed lacked proper elevation that she turned it up. Id. Although the staff acknowledged that the head of R6's bed was down on April 20, 2004, Petitioner disputes that her bed was only elevated to 15 degrees because the last staff member who was in the resident's room prior to the surveyor's observation reported that the bed was elevated. P. Br. at 18; Tr. at 293. Petitioner's argument is based on the testimony of Mona Pilkington, the DON. However, Ms. Pilkington also admitted that she was not present at the time the surveyor made her observation. Tr. at 294. Instead, Ms. Pilkington relied on what she was told by the Restorative CNA who had accompanied the surveyor. The Restorative CNA told Ms. Pilkington that she raised the head of the bed when the surveyor made the comment regarding the low positioning of the bed. Tr. at 296. Thus, I find that the surveyor's testimony stands unrefuted. Petitioner argues additionally that the surveyor's observation that R6's bed was only elevated approximately 15 degrees is an isolated instance insufficient to establish a deficiency. P. Br. at 19. The argument is without merit. Neither the law nor the regulations allow the facility a window of opportunity for engaging in isolated instances of noncompliance that place residents at risk for harm. R6 was placed at risk of suffering serious harm through aspiration when the bed was only slightly elevated and the feeding formula was still infusing. This is particularly true in a resident that suffered from Gastroesophageal Reflux Disease (GERD) and dementia. P. Ex. 21, at 1; Tr. at 34-35. Therefore, I conclude that Petitioner's failure to maintain proper bed elevation for R6 constitutes a deficiency. CMS also maintains that Petitioner failed to ensure that R6 received appropriate treatment and services to prevent aspiration by failing to position and monitor her properly. The SOD reveals that, on several occasions on April 21 and 22, 2004 the head of R6's bed was elevated, but the resident was not. She was, instead, noted to be in the bend of the bed. CMS Ex. 2, at 17-18. A bedspread was draped over both side rails and the rails were covered with solid pads. Id. Therefore, the resident could not be seen from the door of the room. It was also noted in the SOD that staff was aware that R6 had the tendency to scoot down in the bed but no assessment was undertaken to address that issue. CMS Ex. 2, at 22; Tr. at 338-39. In this regard, the DON testified that she had known for approximately two months that the resident had the tendency to scoot down in the bed. Tr. at 316. When asked what the facility had done to address the problem of the resident scooting down, she stated that pillows were used to stabilize her. Id. at 338. However, she added that pillows had been in use since May of 2002 to lessen the effect when the resident slid down. Id. From this testimony, I can draw one of two conclusions: either the facility knew that the resident had been scooting down in the bed for approximately two years, or the use of pillows was an intervention unrelated to the R6's tendency to slide down in the bed. Either way, it is an indication that the facility was not implementing appropriate treatment and services to keep the resident properly positioned to reduce the risk of aspiration. Petitioner argues that R6 was markedly kyphotic (7) and that no mechanical interventions could safely and effectively straighten her back. P. Br. at 14-15. Occupational therapy consultations due to the resident's worsening contractures and pulling herself into a fetal position did not help, according to Petitioner. Id. at 15-16. Petitioner also relies on the testimony of Richard E. May, M.D., to the effect that there was nothing else the facility could have done to keep the resident properly positioned without having to restrain her. Tr. at 236. In spite of that testimony, Dr. May stated that, at the time of the survey, the facility was properly positioning the resident to address the risk of aspiration. Id. The argument is not only without foundation, but also contradictory. Petitioner cannot argue, on the one hand, that it was not possible to position R6 correctly because of the marked curvature of her spine, while on the other hand maintaining that, at the time of the survey, she was properly positioned so as to address the risk of aspiration. Petitioner's other arguments regarding chin tuck position and the correct positioning of a resident with kyphosis do not alter my conclusion that the facility failed to maintain R6's bed elevation between 30 and 45 degrees as required by the care plan and that it failed to monitor and reposition the resident when she scooted down in the bed. It is evident from the DON's and Dr. May's testimony that the facility was oblivious to the resident's need to be repositioned when she scooted down in the bed. Both testified to being unaware of how long it would take the resident to slide down in the bed to the point where she required repositioning. Tr. at 240-42, 338. The DON testified that the resident was checked every two hours, but did not know if she required more frequent repositioning. (8) Id. at 338-39. Furthermore, Petitioner advances no cogent reason as to why the resident was concealed under a bedspread and out of view from someone standing at the door to the room. This constituted an additional risk because if the resident happened to be in distress, she could not be observed except by someone standing right next to her bed. In view of the foregoing, I find that CMS has established a prima facie case that Petitioner failed to correctly position R6, a tube-fed resident with a history of aspiration pneumonia and GERD, in violation of 42 C.F.R. � 483.25(g)(2) (Tag F322). Petitioner has not overcome that showing by a preponderance of the evidence. It is now necessary to consider whether CMS's finding of immediate jeopardy was clearly erroneous.
The term "immediate jeopardy" is defined at 42 C.F.R. � 488.301 to be:
The prima facie evidence strongly supports a finding of an immediate jeopardy level deficiency. As has been stated earlier, R6 was fed by a PEG tube. Someone who is fed by a PEG tube is at an inherent risk for complications from aspiration. Tr. at 212. R6 was at greater risk because she suffered from GERD. Tr. at 34. GERD refers to a condition where the esophageal sphincter that connects between the stomach and the esophagus is not intact, therefore, fluid can reflux back into the esophagus and predispose the individual to aspiration. Id. Consequently, tube-fed patients with GERD have a higher risk of aspiration. Id. Aspiration can lead to conditions such as pneumonia, and in extreme cases, death. Id. at 35-36, 39. Consistent with this, Petitioner's expert, Dr. May, testified that it was better for R6 to be elevated to reduce the risk of fluids flowing back into the esophagus from the stomach. Id. at 217. R6 was further at risk for aspiration because of her severe dementia. P. Ex. 21, at 1; Tr. at 251. Dr. May expressed the opinion that leaving a GERD-afflicted resident who was continuously tube fed 60 ccs of fluid per minute in a position that was close to being flat would put the resident at risk, but not at great risk, for aspiration. Tr. at 253. He qualified his testimony by stating that it would not constitute a great risk if the resident was left flat for only a short period of time. However, Dr. May did not know for how long R6 was left in a flat or almost flat position. Id. Additionally, Dr. May did not consider the instances when the resident scooted down in the bed and was not properly positioned. Therefore, I find that Dr. May's testimony fails to rebut CMS's finding that R6 was placed in immediate jeopardy by the facility's noncompliance. It is also my conclusion, based on the evidence of record, that the instances during which the resident was found improperly positioned, either because the head of the bed was left significantly lower than 30 to 45 degrees or because she had scooted down and was not repositioned, placed her at risk such that she was likely to suffer serious injury, harm, impairment, or death. Petitioner argues that the immediate jeopardy citation is clearly erroneous inasmuch as the measures taken by the facility to abate the deficiency were the same measures that were in place before the survey. P. Br. at 12-13. This argument is not supported by the evidence of record. It is evident that the measures adopted by the facility were not the same, but the crucial issue is not whether the measures were adopted, but rather if the measures were in fact applied. For example, I have already concluded that, on April 20, 2004, the head of the resident's bed was not elevated, even though the care plan required that the head of the resident's bed remain elevated at 30 to 45 degrees at all times, with an indication that the feeding tube be turned off when the bed needed to be lowered. Dr. May testified that, after the survey, the facility adopted the recommendations of the speech therapist and that those recommendations coincided with what the facility was already doing. The measures that he points to certainly were not noted by the surveyor during the April 2004 survey, however. Some of those measures included positioning the resident upright at 45 degrees or higher, and stabilizing with pillows. Tr. at 239. Previously, however, Dr. May had ordered maintaining the resident at 30 to 45 degrees elevation. As to the use of pillows for support, Dr. May stated that, after the survey, pillows were placed on either side for positioning and to keep the resident from rolling over. Id. at 240. After implementing these interventions, R6 was found to be properly positioned greater than 90% of the time. Id. at 241. Thus, she was not only turned side to side several times a day to prevent pressure sores, but also repositioned on an ongoing basis. Additionally, on April 22, 2004, the facility implemented a new policy and undertook immediate steps to protect not only R6, but also other residents that may have been affected by the deficient practices that resulted in immediate jeopardy. CMS Ex. 38. In summary, as noted by CMS, the surveyors considered that increased frequency of monitoring, reassessment of R6 for optimal positioning, and education of the staff regarding the risks and proper care of tube-fed residents was sufficient to abate the immediate jeopardy. CMS Reply Br. at 8, Tr. at 143-44; CMS Ex. 38. Dr. May testified that when R6 was hospitalized on April 22, 2004, he was able to confirm that nothing untoward happened to her. Tr. at 238. Petitioner is unable to establish that the finding of immediate jeopardy was clearly erroneous or non-existent by showing that R6 experienced no harm or injury. Immediate jeopardy exists where a 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. For a finding of immediate jeopardy, it is not necessary to show that the noncompliance caused serious harm; it is sufficient to show that the noncompliance was likely to cause serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001), aff'd, 300 F.3d 835 (7th Cir. 2002). Additionally, I must uphold CMS's determination as to immediate jeopardy unless it is clearly erroneous. 42 C.F.R. � 498.60(c)(2). Moreover, the standard for determining immediate jeopardy is not whether the resident was "at great risk," but whether it was "likely" that she would suffer serious injury, harm, impairment, or death. The evidence of record demonstrates that the facility allowed the head of R6's bed to be almost flat and failed to monitor her for repositioning when she scooted down in the bed. These instances of noncompliance placed R6, who was at an inherent risk of aspiration by the mere fact of being tube fed, in a situation that was likely to cause serious injury, harm, impairment, or death. Furthermore, Petitioner should have foreseen that its failure to properly position and monitor R6 was likely to result in serious harm, injury, or death. Petitioner has not established that CMS's finding of immediate jeopardy is clearly erroneous.
42 C.F.R. � 483.15(a) provides that a facility must promote care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect in full recognition of his or her individuality.
R9 was admitted to the facility on January 16, 2004, with diagnoses that included hypertension and congestive heart failure. She was on Lasix 80 mg., twice a day. On April 21, 2004, during a resident council meeting, R9 complained to the surveyor that a CNA asked her why she called so often. She complained that staff told her children that she turned her call light on too often. CMS Ex. 2, at 4-6.
Ms. Patricia Murphy, a surveyor, testified that Resident 9 was on Lasix 80 mg., twice daily. She added that the stated dosage was high, and required the resident to use the bathroom frequently, within the hour of its administration. Tr. at 160-61. CMS contends that by questioning the resident's frequent calls to be taken to the bathroom, Petitioner engaged in an act of disrespect, and harmed the resident's dignity. CMS Br. at 4. Petitioner, on the other hand, maintains that CMS has failed to establish that its staff was disrespectful towards R9. Petitioner points out that Kimberly Clemmons, the LPN assigned to R9's hall, told the surveyor that the CNAs who cared for the resident denied that they had complained to R9 about her frequent use of the call light. P. Br. at 25; see also CMS Ex. 2, at 5. Petitioner further asserts that the surveyor arrived at her conclusions regarding this deficiency without speaking to the CNAs or to the resident's family. P. Br. at 25. A reading of the transcript provides a tenor of the dialog between the staff and R9 concerning her use of the call light, but there is no indication as to what was in fact said by the staff nor the precise language they employed in addressing the resident. Tr. at 164. It is also noted in the Statement of Deficiencies that the LPN instructed the CNAs that R9 was on a diuretic twice a day and would be expected to use the bathroom frequently. Joyce E. Mobley, the resident's daughter, testified that she would visit her mother almost every day for several hours and never witnessed any staff member treat the resident with disrespect. Tr. at 344. She added that staff never failed to answer the call light. Id. Furthermore, she was not concerned with the complaint aired by her mother because, in the best of circumstances, her mother would find fault with the staff's responsiveness. Id. at 347-48. Thus, whenever, R9 pressed the call light button, she expected someone to show up instantly. Id. at 348. According to Ms. Mobley, all family members agreed with her views on the matter. Id. Inasmuch as it is not clear what was the precise disrespectful language allegedly employed by the facility staff, and since the LPN appropriately advised the CNAs that the resident was on a diuretic, and the daughter could not confirm the deficient conduct, I find that Petitioner has overcome CMS's prima facie case by a preponderance of the evidence. Moreover, the resident's indication that it was the night shift that was non- responsive, appears to confirm the daughter's testimony, in that the resident pointed to staff inadequacy during a time when family was not available to contradict her complaints.
42 C.F.R. � 483.25(a)(3) requires the facility to ensure that a resident who is unable to carry out ADLs receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.
Based on observation, record review and interviews, it was found that the facility failed to provide assistance with ADLs for R10. The resident was assessed as requiring extensive assistance for dressing and personal hygiene. CMS Ex. 2, at 11. On April 21, 2004 at 4:30 p.m., and on April 22, 2004 at 10:30 a.m. and 5:15 p.m., the resident was observed with her hair appearing uncombed, loosely pulled up in braids, with loose hair sticking out from the head. Id. at 11-12. It was also observed that the resident's braids were randomly placed and held with bands. Id. at 12. Although the CNAs stated that they did the resident's hair most of the time and would take it down and braid it for her, the social worker acknowledged that sometimes the CNAs were short on time. She added, however, that the CNAs could "do different ways with braids." Id. On April 22, 2004, during an interview, R10's family member stated that she felt like staff did not fix the resident's hair frequently. It always appeared to be fuzzy. Id.
Petitioner contends that the CNAs entrusted with R10's care groomed her hair on a daily basis. P. Br. at 27. The duty to assist the resident with ADLs included grooming her hair, adds Petitioner, but not in accordance with the personal style preferences of the surveyor. P. Reply Br. at 7-8. Thus, according to Petitioner, the fact that the surveyors did not like hair that was loosely pulled up in braids in random fashion, held with bands, and with loose hair sticking out, does not mean that the resident was not properly groomed. Petitioner argues that CMS's brief acknowledges that facility employees attended to R10's hair on a daily basis and that her hair often came undone during the day due to the resident's propensity to play with her hair after it had been fixed by the nurses. Id. at 7. The record shows that the surveyor observed R10 on several occasions, including at 10:30 a.m. on April 22, 2004, and noted that her hair appeared fuzzy and unkempt. Family members also stated that it did not seem that R10's hair was fixed regularly as they too noticed that it appeared fuzzy. Petitioner alleges that the CNAs did the resident's hair on a daily basis, but failed to have those CNAs present at the hearing as witnesses to those allegations. I do not find that it is mere coincidence that on the days observed by the surveyor as well as family members, R10's hair appeared unkempt. CMS did not acknowledge that R10's hair came undone during the course of the day because of her propensity to play with it once it was fixed by the nurses, but rather questioned the validity of the suggestion by Petitioner. See CMS Br. at 11. CMS bases its argument on the fact that, at 10:30 a.m. on April 22, 2004, the resident's hair appeared uncombed and loosely pulled up in braids. The possibility of the resident upsetting her own hair after it was done by the CNAs was raised obliquely by the administrator when she stated that R10 liked to pat her hair after it was done as "often ladies do," and that "maybe just a little strand may come undone." Tr. at 399. That description does not account for the loose braids and fuzzy hair sticking out. In view of the foregoing, I find that CMS has established a prima facie case that Petitioner failed to substantially comply with the deficiency at Tag F312. Petitioner's general denials are insufficient to overcome CMS's showing by a preponderance of the evidence.
42 C.F.R. � 483.25 provides that the facility must ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.
Based on observations and record review, the facility failed to place Resident 5's (R5's) heel on a clean surface during wound treatment. CMS Ex. 2, at 12. The plan of care dated April 13, 2004, revealed that the resident had a stage IV open area to the left heel. Id. at 13. On April 21, 2004 at 2:20 p.m., the surveyor observed the treatment nurse providing treatment to the resident's left heel and left great toe. Id. The nurse removed the heel protector and dressing from the resident's left foot, cleansed the left heel, and placed it on the protector. The nurse failed to place a clean barrier to prevent possible cross- contamination when she placed the uncovered heel with an open area on the resident's heel protector. Id.
CMS contends that placing the resident's left heel, after it had been cleansed, on a protector that had just been removed, created the potential for bacteria or other harmful substances to enter the wound site. CMS Br. at 12. This potential for harm, adds CMS, was not mitigated by the fact that the nurse subsequently re-cleaned the wound. Id. Petitioner argues that CMS has failed to establish a prima facie case, but offers no persuasive reason for its contention. P. Br. at 28-29. Petitioner further maintains that, assuming the surveyor's observations are true, that they amount to nothing more than an isolated error. Id. at 28. Additionally, states Petitioner, the DON testified that the nurse that was observed performing R5's treatment had received in-service training on January 22, 2004 regarding infection control. Thus, inasmuch as the nurse's error occurred in spite of the facility's training concerning infection control, the citation is inappropriate. Id. at 28-29. I disagree. Petitioner's principal argument here is that its facility was in substantial compliance, and that CMS has failed to establish a prima facie case. I must, therefore, infer that Petitioner has concluded that the nurse providing wound treatment to R5 acted correctly, and in keeping with facility instructions. This is made more evident from the absence of any disciplinary or other corrective action concerning the nurse involved in this deficiency. Petitioner cannot, therefore, now assert that the nurse acted contrary to the training she received regarding infection control. Furthermore, the Departmental Appeals Board (Board) has clearly held that noncompliance exists even in the case of an isolated problem, where the findings involve more than a potential for minimal harm. Koester Pavilion, DAB No. 1750 (2000). In Koester, the Board stated that:
Id. at 37. In this case, Petitioner does not dispute that the nurse caring for R5 allowed the pressure sore on the resident's left heel to come in contact with a surface that may have been contaminated, that the contamination could potentially cause an infection, and that such an infection could cause more than minimal harm. Thus, I find that the care of this pressure sore was evidence of the facility's failure to substantially comply with section 483.25(c)(2). Petitioner has failed to overcome CMS's prima facie case by a preponderance of the evidence.
42 C.F.R. � 483.25(m)(1) provides that a facility must ensure that it is free of medication errors at a rate of 5% or greater.
R17 had a physician's order for Reglan 10cc. CMS Ex. 2, at 27. At 5:15 p.m. on April 21, 2004, the medication nurse was observed to pour Reglan liquid into a cup and check for correct dosage while holding the cup in the air. When asked to confirm the dosage with a syringe, the nurse only drew about eight and a quarter ccs. Id. R16 had a physician's order for Potassium (K Dur)-one tablet each morning. Id. The medication nurse gave the resident a cup of water (holding about 120ccs) with the medication. The resident drank approximately one half a cup and discarded the remainder of the water. The applicable literature instructs that Potassium should be taken with a full glass of liquid. Id. at 27-28. R15 had a prescription for Paxil 20 mg. and Depakote 15 ccs. Id. at 28. On April 21, 2004, at 8:39 a.m., the medication nurse was observed to administer the Paxil and prepared to discard the plastic medicine cup. When the surveyor questioned the nurse regarding the amount of medication that remained at the bottom and on the sides of the cup, she proceeded to rinse the cup twice before clearing all medication from the cup. Id. The Depakote was observed poured into a plastic medication cup. The nurse checked the medication amount holding the cup in the air. When she was asked to confirm the dosage, the nurse drew only 14 ccs into a syringe. Id.
In view of the credible evidence of record, I find that Petitioner has overcome CMS's prima facie case as to Tag F332. My finding is predicated on a discussion of the two most evident examples out of the four examples offered by CMS.
CMS charged that the nurse gave R15 a Paxil tablet that had been crushed and mixed in water, and was prepared to discard the cup although some of the medication remained at the bottom and the sides of the cup. The thrust of CMS's argument is that, since medication residue remained at the bottom and sides of the cup, the resident was not getting the complete prescribed dosage. Mr. Steven Snyder, a pharmacist, testified that the medication itself is water-soluble and quickly dissolves when mixed with water. Tr. at 389-90. What the surveyor observed at the bottom and sides of the cup was not medication, but rather filler and coating. Id. Consequently, the resident ingested the medication that was in solution, and what remained in the cup is the filler and coating. Mr Snyder added that when these substances are ingested, they are not absorbed, but are eliminated by the body. Id. at 390-91.
CMS charged that the medication nurse poured liquid Depakote into a plastic medication cup while she checked the dosage amount holding the cup in the air. When she was asked to confirm the dosage, the nurse drew only 14 ccs into a syringe instead of 15 ccs, as prescribed. Mr. Snyder, the pharmacist, testified that it was possible that one cc difference could be accounted for by the residual that remained in the cup after the nurse drew the medication from the cup with a syringe. Tr. at 378. Additionally, he stated that the therapeutic effect of the medication is not affected by a single cc difference in one instance. Id. at 379-80. He also suggested that the effectiveness of the dosage has to be viewed longitudinally over time, and that a cc difference might be significant in a low dosage such as 5ccs, but not as significant when the prescribed dosage is 15ccs. Id. at 379, 381-82. In view of the foregoing, I find that the identified deficiencies under this Tag posed no greater risk to resident health or safety than the potential for causing minimal harm.
42 C.F.R. � 483.25(m)(2) requires that the facility ensure that residents are free of any significant medication errors.
CMS charged the medication nurse poured liquid Depakote into a plastic medication cup while she checked the dosage amount holding the cup in the air. When she was asked to confirm the dosage, the nurse drew only 14 ccs into a syringe instead of 15 ccs as prescribed. CMS Ex. 2, at 29.
Mr. Snyder, the pharmacist, testified that it was possible that one cc difference could be accounted for by the residual that remained in the cup after the nurse drew the medication from the cup with a syringe. Tr. at 379. Additionally, he stated that the therapeutic effect of the medication is not affected by a single cc difference in one instance. Id. at 379-80. He also suggested that the effectiveness of the dosage has to be viewed longitudinally over time, and that a cc difference might be significant in a low dosage such as 5 ccs, but not as significant when the prescribed dosage is 15 ccs. Id. at 379, 381-82. CMS argues that, of all the examples listed under Tag F333, the medication error regarding Depakote was one that could have made the most significant impact on the resident because it is a medication for seizures or convulsions, and getting a lower dosage of the medication could potentially trigger a seizure. CMS Br. at 29. This assertion by CMS is not supported by the evidence of record. In fact, the only evidence presented with respect to that issue indicates that a one-time difference of one cc will not adversely affect the resident. Tr. at 379-80. I must also note that seizures was not listed on the SOD as one of the conditions diagnosed for R15. CMS Ex. 2, at 29. Pertinent to this is the fact that Depakote is also prescribed as treatment for mania associated with bipolar disorder, and for the prevention of migraine headaches (http://www.rxabbott.com/pdf/depakote.pdf). In view of the foregoing, I find that the identified deficiencies under this Tag posed no greater risk to resident health or safety than the potential for causing minimal harm.
Based on observation in the kitchen, the facility failed to ensure that frozen foods were properly protected from potential cross-contamination (plastic bags open, torn and undated) in two chest freezers. CMS Ex. 2, at 29. The open bags potentially compromised food quality. Id. Additionally, sanitizing solution was observed on a table along with prepared food. Id. at 29-30.
Petitioner did not refute the charge as set forth in the SOD, except to state that CMS presented no evidence at the hearing as to this Tag. See P. Br. at 31. However, I find that the citation in the SOD is sufficient to establish a prima facie violation as to Tag F371.
42 C.F.R. � 483.65(a)(1)-(3) requires that a facility must establish an infection control program under which it investigates, controls, and prevents infections.
Based on observation, record review, and interview, the facility staff failed to wash their hands and change their gloves before flushing a Nasogastric tube for R6. CMS Ex. 2, at 31. The staff also failed to remove their gloves and wash their hands when providing treatment to R5 before obtaining items from the treatment cart. Id. On April 21, 2004 at 2:20 p.m., the surveyor observed the treatment nurse providing treatment to R5's left heel and left great toe. Id. The nurse removed the heel protector and dressing, cleansed the left heel, and placed it back on the heel protector. Afterwards, the nurse reached into the treatment cart and obtained a measuring device without removing her gloves and washing her hands. Id. Resident 6 was assessed as being fed by tube for nutrition. Id. at 32. At 12:18 p.m., the LPN verified placement of the tube by auscultation and air with a stethoscope. She then aspirated the tube for gastric contents and flushed it with water without wearing gloves. Id. Regarding this incident, the DON stated: "you need to secure the tube, wash your hands and put gloves on." Id.
As in addressing Tag F314, Petitioner argues that CMS has failed to establish a prima facie case, but offers no persuasive reason for its contention. P. Br. at 31-32. Petitioner also reiterates the argument that, assuming that the surveyor's observations are true, that they amount to nothing more than an isolated error. Id. at 31. Additionally, states Petitioner, the DON testified that the nurse that was observed providing care for R5 and R6 received in-service training on January 22, 2004 regarding infection control. Id. at 32. Thus, inasmuch as the nurse's error occurred in spite of the facility's training concerning infection control, the citation is inappropriate. Id. Again, I disagree. Petitioner's principal argument here is that its facility was in substantial compliance, and that CMS has failed to establish a prima facie case. I must, therefore, infer that Petitioner has concluded that the nurse providing care to R5 and R6 acted correctly, and in keeping with facility instructions. This is made more evident from the absence of any disciplinary or other corrective action concerning the nurses involved in this deficiency. Petitioner cannot, therefore, now assert that the nurse acted contrary to the training she received regarding infection control. Furthermore, as stated earlier, the Board has clearly held that noncompliance exists even in the case of an isolated problem, where the findings involve more than a potential for minimal harm. Koester Pavilion, DAB No. 1750 (2000). In this case, Petitioner does not dispute that the nurses caring for R5 and R6 failed to wash their hands and wear gloves to control and prevent the spread of infection. By failing to maintain sanitary conditions in the care of its residents, Petitioner created an environment that could potentially cause an infection, and such an infection could cause more than minimal harm. Thus, I find that Petitioner was in violation of 42 C.F.R. � 483.65(a)(1)-(3). Petitioner has failed to overcome CMS's prima facie case by a preponderance of the evidence.
CMS imposed a $3,050 CMP for one day of noncompliance on April 22, 2004. Petitioner contends that CMS failed to specifically provide any basis for a finding of immediate jeopardy that justifies the imposition of a $3,050 penalty. P. Br. at 32. I have already amply discussed the basis for a finding of noncompliance. Indeed, there is not only a prima facie case of noncompliance here, but the preponderance of the evidence is that Petitioner was not complying substantially with the regulatory requirements under 42 C.F.R. � 483.20(k)(2) and 42 C.F.R. � 483.25(g)(20). Furthermore, Petitioner has not met its burden of showing that CMS's determination of immediate jeopardy is "clearly erroneous." Clearly erroneous is a very high standard. Without clear and convincing evidence from Petitioner on this issue, I cannot find CMS's determination of immediate jeopardy to be clearly erroneous. Moreover, there is no issue as to the reasonableness of the CMP imposed, inasmuch as $3,050 is the minimum under the regulations, where it is established that the participating facility has incurred a deficiency that reaches the level of immediate jeopardy. 42 C.F.R. � 488.438(a)(I).
CMS also imposed a CMP of $100 per day effective April 23, 2004 through May 13, 2004, and $50 per day from May 14, 2004 through May 25, 2004. Based on surveys conducted on June 1 and June 8, 2004, CMS determined that the facility returned to substantial compliance on May 26, 2004. CMS Ex. 6. However, inasmuch as CMS failed to establish some of the deficiencies upon which the CMPs were based, I am reducing the $100 per day CMP to $50 per day. Thus, I find that a CMP of $50 per day from April 23, 2004 through May 25, 2004 is appropriate. V. Conclusion Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that Petitioner was not in substantial compliance at the immediate jeopardy level on April 22, 2004, and that the imposition of a $3,050 is reasonable. Additionally, a CMP of $50 per day from April 23, 2004 through May 25,2004 is also reasonable. |
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José A. Anglada Administrative Law Judge |
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1. The facility returned to substantial compliance on May 26, 2004, thus, the only issue before me is the appropriateness of the CMP. CMS Ex. 6. 2. Norma Ann Metheny, Ph.D., is Professor and Dorothy A. Votsmier Endowed Chair in Nursing at St. Louis University, School of Nursing, St. Louis, Missouri. Dr. Matheny has a Ph.D. in education and an M.S.N. in medical-surgical nursing. She has conducted research and published papers regarding aspiration associated with tube feedings. CMS Ex. 46. 3. See also Beverly Health & Rehabilitation-Springhill, DAB CR553 (1998). 4. CMS Exs. 1 and 2 both contain identical versions of the deficiencies cited by the State Agency surveyors. The two exhibits contain different versions of the facility's plan of correction, however. CMS Ex. 1 indicates that it was signed by the facility's representative on May 11, 2004. CMS Ex. 1, at 1. The plan of correction on CMS Ex. 1 includes handwritten additions with completion dates of May 14, 2004. See, e.g., CMS Ex. 1, at 6. CMS Ex. 2 indicates that it was signed by the facility's representative on May 12, 2004. CMS Ex. 2, at 1. Despite purporting to have a later date, however, CMS Ex. 2 does not contain the handwritten additions found on CMS Ex. 1, and many of the completion dates on CMS Ex. 2 are for dates earlier than those listed on CMS Ex. 1. Compare CMS Ex. 1, at 7 with CMS Ex. 2, at 4. I note also that CMS Ex. 1 bears a fax imprint with a date of May 17, 2004. See, e.g., CMS Ex. 1, at 24. For these reasons, it appears to me that CMS Ex. 1 was, in fact, created later in time than CMS Ex. 2. The chronological order of CMS Exs. 1 and 2 is not crucial to my decision, however, and I have chosen to cite to CMS Ex. 2 for most purposes because the pagination of the exhibit tracks the pagination of the original SOD. 5. Aspiration in tube-fed individuals occurs when they regurgitate fluid from the stomach through the esophagus and inhale it into the lungs. Tr. at 32. Aspiration can lead to pneumonia if the aspirated fluid contains bacteria from the stomach or mouth and the bacteria cause an infection in the lungs. Id. 6. The care plan for R6 does not reflect that she was to be repositioned every two hours. CMS Ex. 12, at 7, 13-14. 7. Kyphotic means that the resident was stooped forward with a "dowager's hump" appearance due to multiple compression fractures of the spine. Tr. at 211. 8. As has been noted earlier, there is no documentation that the resident was repositioned every two hours. | |||