SUBJECT:

Lake Cook Terrace Nursing Center,

Petitioner,

Health Care Financing Administration

BACKGROUND

In May 1998, the Illinois Department of Public Health (IDPH) conducted an inspection of Petitioner's facility to determine whether Petitioner was in compliance with federal regulations governing nursing homes participating in the Medicare and Medicaid programs. As a result of this survey, on July 8, 1998, HCFA issued a "Notice of Imposition of Remedies" (Notice) which found that an immediate jeopardy situation existed with regard to the care of one resident for a three-day period beginning May 9, 1998. A civil money penalty (CMP) of $3,050 was imposed by HCFA for each of these three days. HCFA also issued a CMP of $50 per day for four other deficiencies not rising to the level of immediate jeopardy. This penalty was effective May 12, 1998. At a reinspection on July 10, 1998, IDPH determined that these violations were corrected, resulting in HCFA's decision that Petitioner was out of compliance with Medicare requirements for a 59-day period. Petitioner timely requested a hearing by letter dated September 2, 1998.

Specifically, with regard to the immediate jeopardy citation, HCFA alleges that Petitioner violated two regulations: 42 C.F.R. § 483.20(d)(3)(i)⁽¹⁾ (referred to in the IDPH statement of deficiencies and throughout this Decision in lieu of the regulatory citation as F-Tag 281), which provides that the services provided or arranged by the facility must meet professional standards of quality; and 42 C.F.R. § 483.25 (referred to in the IDPH statement of deficiencies and throughout this Decision in lieu of the regulatory citation as F-Tag 309) which provides that each resident must receive, and the facility must provide, the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. Petitioner was also cited for deficiencies which constituted noncompliance with participation requirements but did not constitute immediate jeopardy. These included: 42 C.F.R. § 483.15(a) (F-Tag 241); 42 C.F.R. § 483.15(h)(2) (F-Tag 253); 42 C.F.R. § 483.60(e) (F-Tag 432); and 42 C.F.R. § 483.75(m) (2) - (4) (F-Tag 518).

This case was originally assigned to Administrative Law Judge Mimi Hwang Leahy. The case was reassigned to me on December 6, 1999. I held a hearing in Chicago, Illinois, on December 21, 1999. At the hearing, I received 30 exhibits from HCFA (HCFA Exs. 1 - 30), although HCFA Exs. 27 - 29 were withdrawn during the course of the hearing and 19 exhibits from Petitioner (P. Exs. 1 - 19). I heard the testimony of two witnesses called by HCFA (Joella Daniels, R.N. and Elizabeth Honiotes, R.N.) and three witnesses called by the Petitioner (Jacob Salomon, M.D., Alma Mendoza, R.N., and Svetlana Gornet, R.N.). I received initial (HCFA Br. and P. Br.) and response briefs (HCFA Resp. Br. and P. Resp. Br.) from both parties.

DISCUSSION

The principal issue in this case is whether Petitioner's conduct with respect to one of its residents caused it to be out of compliance with Medicare participation requirements such that its actions constituted immediate jeopardy to that resident. I find that HCFA did not prove that Petitioner's conduct with respect to this resident supported a finding of immediate jeopardy and that Petitioner's conduct was in fact not deficient at all. I find to be clearly erroneous HCFA's determination that Petitioner placed the resident in question in immediate jeopardy.

Resident 3 (R3), the resident in question, was a long-time resident of Petitioner's facility, having resided there for 14 years before the occurrence of the events that are the subject of this proceeding.⁽²⁾ HCFA Ex. 19, at 1; Transcript (Tr.) at 95. At approximately 1:00 a.m. on the morning of May 9, 1998, R3 was discovered to have tissue protruding from her body. HCFA Ex. 18, at 3. The nurse on duty assessed the problem to be a uterine or vaginal prolapse. Id. R3 indicated she was not in any discomfort or pain and her vital signs were normal. Id. The following morning, at 10:00 a.m., the nurse's notes indicate that R3 again had no complaints of pain or evidence of discomfort. Id. at 4. The nurse stated that the prolapse was "of uterus (possibly)" and noted a small amount of red blood on R3's pad. Id. The nurse notified R3's physician, Dr. Velazco, and indicated that he stated he would see R3 when he came in later in the week, but that if R3 suffered pain he should be notified. Id. The nurse unsuccessfully attempted to push the prolapse back in. Id. R3's vital signs remained normal. Id.

That evening, R3 ate her entire dinner in bed, continued to evidence no pain or discomfort, and once again had a "small amount" of bloody secretion on her pad, but no actual bleeding. Id. The nurse at that time observed a "decrease in size from 3 pm" and R3's vital signs continued to be normal. Id. When the nurse checked R3 at 10:00 p.m., the nurse did not observe any bleeding. Id.

On May 10, 1998, at 3:30 p.m., R3 was observed sleeping in bed and was easily awakened. Id. Tissue was still protruding and a small amount of bleeding was noted. Id. An attempt by a nurse to push the prolapse in was met by R3 with resistance, including R3's screaming and trying to remove the nurse's hand. Id. That evening, as noted at 10:30 p.m., the nurse on duty referred to the prolapse correctly as a "rectal" prolapse. Id. Once again, no bleeding was noted. Id.

On May 11, 1998, at 11:30 a.m., R3 was noted to still have a mass protruding out of her rectum. At this time it was observed to be cherry red in color and the size of a tennis ball. Id. A small amount of bleeding was noted in R3's pads. Id. R3 still denied that she was in pain. Id. The nurse also noted that the resident was (not surprisingly) lying on her side at all times. Id. Dr. Velazco was alerted to this situation and he arranged for appointments with gastrointestinal consultants to be set up for R3, although the earliest appointment available was not until May 28. Id.; HCFA Ex. 3,
at 12.

Finally, on May 12, 1998, at 3:40 p.m., the nurse's notes indicate for the first time that R3 complained of pain. HCFA Ex. 18, at 1. Some red blood was observed. Id. Nurse's notes at 6:00 p.m. indicate that Dr. Velazco finally examined R3 and quickly arranged for her to be sent to the hospital via ambulance. Id. R3 remained in the hospital for several days before surgery was performed, largely because she had continued on a solid food diet since the appearance of her prolapse and her surgeon wanted her on a liquid diet for several days to reduce the chances of problems during and after her surgery. Tr. at 39; HCFA Ex. 3, at 13, 16.

On May 15, 1998, Jacob Salomon, M.D., surgically repaired R3's prolapse. P. Ex. 1. The surgery was successful. Id.

Dr. Salomon testified at the hearing that it is often difficult to differentiate between rectal and uterine prolapses and that he has known of doctors who confused the two, given that the openings in question are so close together. Tr. at 145, 155 - 156. He analogized the prolapse to a hernia, in that, due to a muscle weakness, tissue protrudes through a muscle which normally contains the tissue. Id. at 138 - 139. In a rectal prolapse, the rectum, secondary to straining or constipation, telescopes outside the body. Id. In a uterine prolapse, the uterus can prolapse outside the vagina. Id. at 140. Neither a uterine nor a rectal prolapse is normally a life threatening situation. Id. Prolapses can be intermittent and frequently go back in on their own if small enough. Id. at 141, 144 - 145. Normally, in the early phases of a prolapse, the proper treatment would be bed rest combined with gentle pressure to push the prolapse back into the body. Id. at 145.

Improper treatment of a prolapse can cause complications. If the prolapse is out for a long time, from four - five days to a week, it can swell, become dry, inflamed, infected, and even gangrenous. Id. at 141, 149 - 150. Dr. Salomon indicated that it would be important to examine the prolapse on a daily basis to make sure the tissue in question was still viable, and that a nurse should be able to do such an examination. Id. at 152. He indicated that any bleeding should be reported to the doctor, and that a rectal prolapse shouldn't be pushed back if it causes pain. Id. at 158. He indicated that he would have examined a patient with this condition one to two days after discovery, even if there was just spotting. Id. at 152, 164 - 165. He stated that the spotting on the pads in this case was just evidence of irritated bowels, that R3's prolapse was neither necrotic nor gangrenous, and that there was no significant bleeding. Id. at 162 - 163.

I find that R3 was generally a rather difficult resident and patient. She suffered from dementia, had a tendency to frequently scream, had difficulty with her activities of daily living, and was resistive to care. P. Exs. 8 - 14. She was frequently described as "uncooperative." P. Ex. 6; HCFA Ex. 18, at 4; Tr. at 177 - 178, 196.

The testimony of two nurses, Alma Mendoza and Svetlana Gornet, was consistent in confirming the entries in the nurse's notes regarding the description of the prolapse, when Dr. Velazco was notified, the three attempts to push the prolapse back in, and R3's temperament See HCFA Ex. 18. Although not all entries in the nurse's notes were made by these two witnesses, I have no reason not to believe the contents of the other nurse's notes. While two changes were made to the nurse's notes at a later date to correct the initially incorrect description of the prolapse as vaginal or uterine, the corrections were obviously made openly and not to cover up an initially incorrect description or diagnosis, but only to correct it. Id. at 3, 4.

Ms. Mendoza, who is a nurse at Petitioner's facility, testified that she had seen R3 regularly during the seven years she had worked at the facility, and that when she saw her in the days after the prolapse was discovered, she did not appear to be in distress, she just had a smear of blood on her pad, and she had normal vital signs. Tr. at 177 - 182.

Ms. Gornet, who has been the Director of Nursing Services at Petitioner's facility since shortly after the events at issue, and who was the Assistant Director of Nursing at the facility for the previous five years (Id. at 194 - 195), testified that she first saw the prolapse on May 11, 1998, shortly after it was correctly diagnosed as rectal, and that R3 denied being in any pain at that time. Id. at 197 - 198, 200. She stated that she called Dr. Velazco who directed Petitioner to set up a consult for R3. Id. at 198 - 199; HCFA Ex. 18, at 4. She also testified that when she made rounds with Dr. Velazco on May 12, he examined R3 and decided that she needed to be sent to the hospital for surgery immediately. Tr. at 201.

Joella Daniels of IDPH testified as to her survey of the facility from May 12 - 15, 1998. A nurse by training, and an experienced surveyor (Id. at 23 - 24), on May 12, 1998, Ms. Daniels observed R3, who she had recognized from previous surveys. Id. at 29 - 30. She found R3 in the fetal position in bed and noted that she appeared to be in pain. Id. at 30. In previous visits, R3 had not been on complete bedrest. Id. R3 told Ms. Daniels that her "Tooshie" hurt, and that she was cold. Id.; HCFA Ex. 3, at 12.

In discussing her recommendation for an immediate jeopardy citation, Ms. Daniels indicated that the factors she considered included the 10-hour delay between the initial discovery of the prolapse and Dr. Velazco's notification, the initial misdiagnosis of the prolapse as uterine rather than rectal, the fact that R3 was not given any pain medication until May 12, 1998, that the doctor was not notified of the pain that R3 was in, the failure to notify the doctor that R3 was bleeding, and the need to wait three days after hospitalization to do surgery because R3 had been fed a normal diet during the period between discovery of the prolapse and her hospitalization. Tr. at 36 - 37, 39, 59 - 61. She testified as to her conversations with Dr. Velazco, who told her he was not notified concerning pain and bleeding, or that R3 had been resistant to care when the nurses attempted to reduce the prolapse. Id. at 37, 58 - 59; HCFA Ex. 16, at 9. Her findings of immediate jeopardy for F-Tags 281 and 309 were supported by the same conclusions - that professional standards were not met in the care of R3 due to inaccurate and incomplete assessments of her condition, the failure to appropriately notify a physician and clarify and document the physician's orders, the alteration of records, the failure to provide pain management, the use of improper procedures causing pain, the improper feeding, and the several days of social isolation (due to her being confined in bed). Tr. at 59 - 61.

The other witness for HCFA, HCFA employee Elizabeth Honiotes, echoed much of Ms. Daniels' testimony. An experienced nurse and HCFA surveyor who has conducted 110 surveys (Id. at 97 - 99), she had a major role in HCFA's determination that the treatment of R3 by Petitioner constituted immediate jeopardy. She stated that a combination of the inaccurate assessment of the prolapse, the delay in notifying the treating physician of an accurate assessment, the bleeding and pain (which were not reported to R3's physician), the inappropriate attempts to reduce the prolapse, the potential for harm (hemorrhage and pain), and R3's bedridden status were the bases for recommending the immediate jeopardy findings. Id. at 103 - 106. She also stated, on cross- examination, that she was not aware that there was no indication in the nurse's notes that would indicate R3 was in pain prior to May 12, 1998, and that she had no recollection as to the extent of bleeding. Id. at 120 - 121. She also indicated that perhaps Dr. Velazco could have done more after first being notified of R3's situation, and that he was wrong in not doing so. Id. at 122 - 123.

In evaluating all the testimony and evidence, what strikes me is my difficulty in determining what, if anything, Petitioner should have done differently with regard to the care of R3 during the time period at issue. Thus, while HCFA has argued that one of the factors in assessing immediate jeopardy was the delay in notifying Dr. Velazco, I have seen no evidence whatsoever that would indicate that the initial appearance of the prolapse was a serious enough event to warrant notifying a physician in the middle of the night, given that there was no real bleeding, no complaint of pain, and the fact that prolapses frequently disappear on their own. Nothing in the record suggests that the overnight delay in calling Dr. Velazco would have any negative impact on R3's treatment. Dr. Salomon indicated that it is normal treatment to wait a while and see if a prolapse goes in on its own, or whether with gentle pressure it can be returned.

As to the misdiagnosis of the prolapse, Dr. Salomon indicated that it was very easy to confuse the two types of prolapses mentioned here, due to the proximity of the openings in question. From the evidence I have seen and heard, I question why Dr. Velazco did not visit his patient before his regularly scheduled rounds. Although it is likely that a visit from a doctor would have made it evident that the prolapse was of the type that would require hospitalization and surgical repair, I find it difficult to charge the facility with any noncompliance with regulations regarding the standard of care where the only deficiencies that may have contributed to R3's condition were the result of her treating physician's action or lack thereof.

The written exhibits, confirmed by the testimony of two facility nurses, Ms. Gornet and Ms. Mendoza, indicate that Dr. Velazco was told of the prolapse reasonably quickly, that his instructions were followed throughout, that the nurses observed staining or spotting and not significant bleeding ( see HCFA Ex. 18; Tr. at 179, 180, 182, 197 - 198, 200; and see Dr. Salomon's testimony at Tr. at 146, 163), that R3 showed neither pain nor discomfort until the day she was finally seen by the doctor and sent to the hospital. I found both Ms. Mendoza and Ms. Gornet to be fully credible. The only testimony I heard that was really inconsistent with their testimony was Ms. Daniels' recounting of her conversation with Dr. Velazco, where he allegedly stated he was not accurately informed of R3's condition. However, Dr. Velazco's statements, as reflected in Ms. Daniels' notes in HCFA Ex. 16, are not really inconsistent with the testimony reflected in the nurse's notes and in the testimony of Ms. Mendoza and Ms. Gornet. Dr. Velazco apparently stated that he was not informed of bleeding and pain. HCFA Ex. 16. However, the evidence consistently shows there was only staining, not bleeding, and that R3 never complained of pain, except when there was an attempt to push the prolapse back in, at least not until the day Dr. Velazco finally examined her.

HCFA points out that Dr. Velazco could have been called by Petitioner in support of their case, and implies that Dr. Salomon's testimony should not be given full credit since he was a member of the same practice as Dr. Velazco, and that Petitioner's Medical Director, Dr. Dayan, was in the same practice. HCFA also points out that Dr. Salomon was not paid for his testimony. I find that in spite of his being a colleague of Dr. Velazco, Dr. Salomon was quite candid in assessing the quality of care given to R3, basically stating that, if he were the treating physician, he would have visited R3 based on the information that was given to Dr. Velazco. Thus, on redirect and recross, Dr. Salomon stated he would examine a patient even if she was just spotting, as was R3, rather than actually bleeding, although he further maintained that this prolapse was not necrotic or gangrenous, that there was no significant bleeding, and that it clearly was not a life threatening situation for R3. Tr. 162 - 165.

In order to prevail, Petitioner must meet the burden of proof described in Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center, vs. U.S. Dept. of Health and Human Services, No. 98-3789, at 21 - 38 (D.N.J. May 13, 1999). Thus, HCFA had the burden at the hearing of coming forward with evidence sufficient to establish a prima facie case, while Petitioner would have the burden of coming forward with evidence sufficient to establish the elements of any affirmative arguments or defenses. The preponderance of the evidence standard is applied here, except that any finding as to the level of noncompliance by a nursing facility must be upheld by me unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2). Since I find that there is no noncompliance by Lake Cook with regards to the immediate jeopardy citation, the clearly erroneous standard does not apply to the facts of this case.

With respect to the 59 days of violation for the various lower scope violations cited by HCFA, I find that these violations were in fact committed and the minimum penalty of $50 per day for 59 days, or $2950, is appropriate. Testimony and exhibits establishing these violations have been by and large unrefuted by Petitioner (See P. Br. at 29) and, since the penalty imposition is the minimum, there is no real issue as to the amount, other than duration. Petitioner has introduced no evidence supporting a finding that these violations were abated prior to the date alleged by HCFA.

In its brief, Petitioner requested that if I decided not to sustain the immediate jeopardy determination I either remand the case to an "appropriate party" for the assessment of the appropriate CMP amount for the non-immediate jeopardy deficiencies or, alternatively, that Petitioner be given a chance to request a reduction in the amount of the CMP pursuant to 42 C.F.R. § 488.436. Id. at 29 - 30. I am denying both requests.

With regard to Petitioner's first request, HCFA has imposed the minimum CMP provided for by regulation for deficiencies at the non-immediate jeopardy level (42 C.F.R. § 488.438(a)(ii)) and, thus, there is no reason for me to consider remanding the case as no other CMP amount would be applicable. With regard to Petitioner's second request, the regulation at 42 C.F.R. § 488.436(a) makes clear on its face that to get a reduction in a CMP a petitioner must waive the right to a hearing, in writing, within 60 days from the date of HCFA's notice of the imposition of a CMP. There is no regulatory support for the waiver of only some part of a CMP after hearing, which is what Petitioner is requesting here. Thus, as Petitioner did not request a waiver of hearing within 60 days of HCFA's notice imposing the CMP in this case, this section of the regulations is not applicable to Petitioner.

1. As a result of a survey completed on May 18, 1998, by the IDPH, Petitioner was cited by HCFA for two violations of Medicare participation requirements (F-Tags 281 and 309) at the immediate jeopardy level.



2. HCFA assessed the minimum CMP for such deficiencies, $3050 per day for three days.



3. HCFA also determined that Petitioner violated four other Medicare participation requirements (F-Tags 241, 253, 432, and 518) at a level that was less than immediate jeopardy.



4. HCFA assessed the minimum CMP for such deficiencies, $50 per day until Petitioner came into compliance with participation requirements.
5. Petitioner came back into compliance with Medicare participation requirements as of July 10, 1998.



6. R3 was a long-term resident of Petitioner's facility.



7. On May 9, 1998, R3 was discovered to be suffering from a prolapse, a non-life threatening health condition.



8. At all times, Petitioner's physician was kept informed of R3's condition.



9. All of R3's physician's instructions were properly carried out by Petitioner's staff.



10. Petitioner was not out of compliance at any time with Medicare participation requirements with regard to F-Tags 281 and 309.



11. HCFA's determination that Petitioner's conduct with regard to R3 constituted noncompliance with participation requirements such that it constituted immediate jeopardy to R3 is clearly erroneous.



12. As to the non-immediate jeopardy level deficiencies alleged by HCFA at F-Tags 241, 253, 432, and 518, HCFA has presented a prima facie case that these deficiencies existed during the time alleged and Petitioner has presented no evidence to refute HCFA's allegations.



13. I sustain the CMP of $50 per day for 59 days based on Petitioner's noncompliance with participation requirements which did not amount to the level of immediate jeopardy.

Marc R. Hillson
Administrative Law Judge

1. On March 23, 1998, this regulation was renumbered without change and is now to be found at 42 C.F.R. § 483.20(k)(3)(i). Petitioner argues that HCFA thus cannot establish a prima facie case based on 42 C.F.R. § 483.20(d)(3)(i) because it did not exist at the time of the survey and Notice. However, an appellate panel of the Departmental Appeals Board has held that a petitioner ". . . cannot reasonably argue that it was misled by the reference to the incorrect subsection when the nature of the alleged violations together with the citation to the quality of care requirement clearly notified [petitioner] of the deficiency. Moreover, any long-term care facility certified under Medicare is presumed to be on notice of program requirements through the applicable regulations." Oak Lawn Pavilion, Inc., DAB No. 1638 (1997). Following this line of reasoning, HCFA's citation of the prior regulatory citation, where the language of the regulation itself did not change and is still a subsection of 42 C.F.R. § 483.20 (the regulation governing resident assessment), does not here preclude HCFA from imposing the deficiency finding and the CMP based on that finding.

2. Where HCFA and Petitioner have introduced the same document into evidence as an exhibit, I cite to HCFA's exhibit.