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CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Britthaven of Guilford,

Petitioner,

DATE: September 08, 2004
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-01-536
Decision No. CR1210
DECISION
...TO TOP

DECISION

For the reasons stated below, I conclude that Britthaven of Guilford (Petitioner or Facility) was not in substantial compliance with Medicare conditions of participation governing long-term care facilities from December 28, 2000 through February 13, 2001; February 14, 2001 through March 2, 2001; March 3, 2001 through March 8, 2001; and March 9, 2001 through April 25, 2001. Accordingly, I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties (CMPs) in the amount of $200 per day from December 28, 2000 through February 13, 2001; $100 per day from February 14, 2001 through March 2, 2001; $7,000 per day from March 3, 2001 through March 8, 2001 due to an immediate jeopardy finding; and $100 per day from March 9, 2001 through April 25, 2001.

I. Background

A. The procedural background

Petitioner is a skilled long-term nursing facility located in Greensboro, North Carolina. The North Carolina Department of Health & Human Services (State agency) conducted a complaint survey that was completed on December 28, 2000 (December survey). The State agency cited Petitioner for alleged deficiencies. On March 23, 2001, Petitioner timely appealed the imposition of remedies for the December survey. The State agency conducted surveys of Petitioner on February 14, 2001 (February survey) and March 12, 2001 (March survey). The State agency again cited Petitioner for alleged deficiencies. A revisit survey was completed on April 26, 2001, and, eventually, Petitioner was found to be back in substantial compliance on April 25, 2001. Amended appeals were filed by Petitioner on April 30, 2001 and June 1, 2001, to challenge all three surveys.

After a hearing was scheduled in the case, Petitioner waived its right to an oral hearing and moved that the case be decided on the pleadings and exhibits pursuant to 42 C.F.R. 498.66. Thereafter, a briefing schedule was established and on August 8, 2003, Petitioner submitted Petitioner's Final Brief (P. Br.) with eight proposed exhibits and two affidavits. The two affidavits were from Todd King, Petitioner's Director of Clinical Services and a pharmacist, and Janice Somers, a Nursing Consultant for Petitioner. On September 8, 2003, CMS submitted CMS' Memorandum in Support of Judgment on the Documentary Evidence (CMS Br.) along with 14 proposed exhibits and one affidavit. The affidavit was from Laura Edwards, a former State agency surveyor. On October 24, 2003, Petitioner filed Petitioner's Reply to CMS's Memorandum in Support of Judgment on the Documentary Evidence (P. Reply). All proposed exhibits are admitted into the record without objection.

B. Applicable law and regulations

Petitioner is considered a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated 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 determine whether the facilities are complying with federal participation requirements. 42 C.F.R. 488.10 - 488.28. The regulations contain special survey conditions for long-term facilities. 42 C.F.R. 488.300 - 488.335. Under Part 488, a state or CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. The regulations at 42 C.F.R. Part 488 give CMS a number of different remedies that can be imposed if the facility is not in compliance with Medicare requirements. Id.

The regulations specify that a CMP 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 CMPs, of 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), (d)(2). The lower range of CMPs, of 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)(2).

The regulations define the term "substantial compliance" to mean "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.

When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must then overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB) (D.N.J., slip op. May 13, 1999); Batavia Nursing and Convalescent Center, DAB No. 1904 (2004). Under Hillman and Batavia, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Once CMS has established a prima facie case of noncompliance, Petitioner has the burden of proving, by a preponderance of the evidence, that it complied substantially with participation requirements. Hillman, at 3-8. Batavia, at 7-20.

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term care facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. 488.408(g), 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991).

II. Issues

The issues in this case are: whether CMS had a factual basis to impose remedies against Petitioner for failing to comply substantially with federal requirements; and if the CMPs are authorized, whether the amounts imposed are reasonable; also, whether CMS's determination of immediate jeopardy for the March survey was clearly erroneous; and whether the time period of determined immediate jeopardy is correct.

III. Findings of fact and conclusions of law

I have examined closely all of the evidence of record to determine whether Petitioner was complying with participation requirements and to decide whether a CMP may be imposed against Petitioner for each separate survey at issue. During the December survey, Petitioner was cited for having failed to meet two requirements for participation in the Medicare program. These deficiencies are identified by CMS as "Tags" and refer to particular regulatory requirements. The following tags from the December survey are at issue:

    1. F309 - Quality of Care - 42 C.F.R. 483.25

    2. F324 - Quality of Care - 42 C.F.R. 483.25(h)(2)

Following the February survey, CMS cited Petitioner for failing to meet two requirements for participation in the Medicare program. The following tags are at issue:

    1. F157 - Resident Rights - 42 C.F.R. 483.10(b)(11)

    2. F309 - Quality of Care - 42 C.F.R. 483.25

Following the March survey, CMS cited Petitioner for failing to meet one Medicare participation requirement. CMS also determined that this deficiency presented immediate jeopardy between March 3, 2001 and March 8, 2001. The following tag is at issue:

    1. F157 - Resident Rights - 42 C.F.R. 483.10(b)(11)

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each of my ultimate Findings below as a separate heading. I discuss each Finding in detail, including the results of the survey, whether the results are supported by the evidence of record, and whether Petitioner has met its burden to overcome the allegations the surveyors made.

The December Survey

A. CMS proved by a preponderance of the evidence that Petitioner was not in substantial compliance with Medicare participation requirements from December 28, 2000 through February 13, 2001.

1. Petitioner failed to comply with the requirement as set forth at 42 C.F.R. 483.25.

Tag F309

Section 483.25 of 42 C.F.R. requires that the facility provide the necessary care and services so that each resident can attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. I find that, with respect to the three residents referred to by CMS for this deficiency, Petitioner failed to provide necessary services to ensure the residents' highest practicable physical well-being. Residents 1 and 2 discussed below incurred actual harm as a result of Petitioner's deficiencies.

Resident 1 (1)

Resident 1 suffered from osteoporosis, among other conditions. P. Ex. 5, at 2. (2) CMS alleged that on November 16, 2000, Resident 1 complained of severe pain, that she cried out even if she was moved minimally, that she did not want to be touched and that even at 3 a.m. on November 17, 2000, Resident 1 complained of severe pain in her right leg and her right knee was swollen. CMS Ex. 1, at 1.

On November 17, 2000, the nursing staff sent a fax to a physician requesting an x-ray of Resident 1's right leg. Id. According to CMS, there was no indication of any additional attempts to reach the physician and follow-up on the x-ray request for Resident 1. Id. The x-ray was finally ordered on November 21, 2000. Id. at 2. The x-ray report, dated November 22, 2000, indicated that Resident 1 had a severely comminuted fractured femur in her right leg. CMS Ex. 1, at 1; CMS Ex. 2, at 5.

Petitioner contends that the facility did follow up on Resident 1's pain in her right leg by calling the resident's physician and obtaining a new prescription of the pain medication Vioxx. P. Br. at 4. Petitioner also asserts that the nursing staff made numerous attempts to reach Resident 1's physician to obtain an x-ray and while waiting for a response, administered the pain medication to Resident 1 as needed. Id. Petitioner argues that the delay in Resident 1's x-ray is irrelevant as to whether Resident 1 suffered actual harm because she was not a surgical candidate and the physician's orders did not change as a result of what was revealed in the x-ray. P. Reply at 2.

Notwithstanding counsel's statements in her brief, Petitioner provided no evidence that staff members of the facility repeatedly tried to contact the physician to obtain an x-ray for Resident 1. (3) Another ALJ in Community Nursing Home, DAB CR770 (2001), analyzed a very similar situation. In that case, the ALJ concluded that the, "resident was in unnecessary pain for nearly three days because Petitioner's staff failed to assess the resident and failed to follow up on its initial communication with the resident's physician about the resident." Community, at 12-13.

In this case, the staff requested an x-ray and obtained a new prescription for Vioxx but failed to follow-up with Resident 1's physician. It is intuitively obvious, in any case, that knowing Resident 1 had a severely comminuted fracture would not only affect how the Facility's staff assisted Resident 1 with her daily activities from November 17 until November 22, but a determination of the cause of Resident 1's condition would also affect the level of treatment that staff provided for Resident 1. Petitioner provided no evidence that the staff took into account Resident 1's pain complaints by treating her in any different way. Despite the fact that Resident 1 was not a surgical candidate, the fracture could have required additional attention by the facility staff as well as stronger pain medication given her condition. (4) I agree with the ALJ in Britthaven of Goldsboro, DAB CR1148 (2004), who pointed out that an argument that no benefit would have accrued by contacting the resident's physician is misplaced. A facility must take action mandated by a resident's condition. I find, therefore, that Petitioner, by not aggressively pursuing an x-ray for Resident 1, failed to provide her necessary services for her highest practicable well-being.

Resident 2

Resident 2 was admitted to the facility on September 8, 2000 and suffered from Parkinson's Disease and dementia. CMS Ex. 1, at 2. Parkinson's is a disease that affects motor skills and control, and both Parkinson's and dementia are risk factors for falls. Edwards Declaration. Resident 2 fell on December 9, 2000 when she was trying to get out of bed. CMS Ex. 1, at 2; CMS Ex. 3, at 4. On December 12, 2000, the nursing staff ordered an x-ray and on December 13, 2000 the x-ray revealed a right femoral neck fracture. Id. Resident 2 was transferred to the hospital for a surgical right hip pinning. Id. CMS alleges that Petitioner delayed providing necessary services to Resident 2 and, therefore, deprived her of her highest practicable well-being. CMS also alleges that Resident 2 fell nine times between her admission and December 9, 2000, when she broke her hip. According to CMS, Petitioner did not provide adequate assistance devices and supervision to prevent accidents. (5)

Petitioner argues that after Resident 2's December 9, 2000 fall, "facility staff immediately assessed the resident and found no evidence of injury." P. Br. at 5. Petitioner further argues that the "nurse's notes of December 11, 2000 indicate [that] the resident voiced no complaints of pain from the fall." P. Ex. 6, at 1. However, the staff continued to monitor Resident 2, according to Petitioner, and later in the day, a nurse's note explained that Resident 2 appeared to be weaker on her feet. Id. Petitioner contends that when Resident 2 did complain of pain on December 12, 2000, the facility "immediately responded" by contacting the resident's physician and an x-ray was ordered. P. Br. at 5. When the broken hip was diagnosed, the facility was notified and Resident 2 was transferred to the hospital. Id.

Petitioner does not dispute that Resident 2 fell trying to get out of bed on December 9, 2000. The Facility's nurses' notes, however, do not discuss the extent of the staff's assessment of Resident 2 after the fall. Vital signs were taken and a note that no acute intervention was needed was charted. CMS Ex. 3, at 16. Indeed, apparently Resident 2 voiced no complaints of pain until December 12, 2000. Id. As noted in Western Care Management Corp., D/B/A Rehab Specialties Inn, DAB No. 1921 (2004), however, a facility should have concerns about a possible hip fracture when a person prone to hip fractures falls. Given Resident 2's age, 78 years, and her diagnoses, hip fracture was a distinct possibility. Given her many previous falls, Petitioner may have been lulled into thinking Resident 2 would not suffer injury from her falls. On the contrary, I find it was only a matter of time until Resident 2 was injured. Petitioner's failure to increase assistance devices and supervision - as discussed with respect to Tag F324 below - equates with a lack of necessary services to allow Resident 2 to maintain her highest practicable well-being.

Moreover, with respect to CMS's allegations regarding Tag F309, I find it hard to believe that Resident 2 suffered no pain between December 9, the date of the fall, and December 12, when she was first charted as having complaints of pain. (6) But certainly, when the staff noticed on December 11, 2000, at 10 p.m., that Resident 2 appeared to be "weaker on feet," staff should have enlisted physician services. P. Ex. 6, at 1. A determination at that time could have possibly saved Resident 2 from at least one additional day of pain that she most likely had to endure. It was not until 2:30 p.m. the next day, after Resident 2's expressed complaints of pain that an x-ray was ordered. CMS Ex. 3, at 17. It is the facility's duty to provide the necessary care to ensure the highest practicable physical well-being of a resident. Petitioner clearly did not take the essential steps to ensure Resident 2's highest practicable physical well-being.

Resident 3

I find that, with respect to Resident 3, Petitioner did not rebut by a preponderance of the evidence CMS's claim that Petitioner was not in substantial compliance with 42 C.F.R. 483.25. Coumadin is a medication commonly referred to as a "blood thinner" that is used to prevent blood clots and requires strict dosing and monitoring. Edwards Declaration, at para. 16. Resident 3 was at high risk for blood clots due to suffering from multiple pulmonary thrombo-emboli with deep vein thrombosis and aortic insufficiency. CMS Ex. 1, at 3; Edwards Declaration, at para. 17. If Resident 3 did not take enough of this type of anticoagulant, she would still be at an increased risk for blood clots. If Resident 3 had too much Coumadin in her system, it would create a risk of uncontrollable hemorrhages. Id., at para. 16.

CMS alleges that, on September 20, 2000, Resident 3's physician prescribed 2 mg of Coumadin to be taken every day except Fridays. Additionally, Resident 3 was prescribed 3 mg of Coumadin on Fridays only. On October 10, 2000, Resident 3 received a new order to take 2.5 mg of Coumadin daily - including Fridays. CMS Ex. 1, at 3. CMS contends that while the Petitioner transcribed into its Medical Administration Record (MAR) on October 10th, the new order for Coumadin, 2.5 mg, Petitioner did not transcribe the discontinuation of the September 20th order for 3 mg of Coumadin on Fridays only. CMS alleges that, as a result, Resident 3 received 3 mg of Coumadin on October 13th, and 20th, in spite of the change to 2.5 mg each day. CMS also alleges that on October 27th, both the 2.5 mg and 3 mg dosages were given to Resident 3. CMS Ex. 1, at 3; CMS Br. at 10. Therefore, according to CMS, for the weeks of October 10, 2000 and October 17, 2000, Resident 3 received 18 mg of Coumadin instead of the prescribed 17.5 mg each week, and during the week of October 24, 2000, Resident 3 received 20.5 mg. CMS Ex. 1, at 3.

In sum, CMS alleges in the Statement of Deficiencies (SOD or Form 2567) that because of the conflicting orders, Resident 3 was given .5 mg too much Coumadin during the weeks of October 13 and 20, 2000 and more than twice the prescribed dose on October 27, 2000. CMS also alleged in the SOD that Petitioner's administrator and nursing consultant admitted the Coumadin was given incorrectly, and that Petitioner had no plan in place to prevent transcribed errors on the MAR. CMS Ex. 1, at 4.

CMS also seems to argue that the two orders dated September 20, 2000 were so significantly different from each other - in that one order was for Resident 3 to take 2.5 mg of Coumadin daily, except on Fridays, which could have resulted in Resident 3 receiving only 12 mg total per week; and the other order for 3 mg of Coumadin only on Fridays would have resulted in Resident 3 receiving a total of only 3 mg per week - that someone on the staff should have questioned the orders and the way in which the orders were transcribed on the MAR. According to CMS, having significantly inconsistent orders created a risk that Resident 3 would receive too little Coumadin. CMS Br., at 9.

Petitioner contends the two orders of September 20, 2000 were to work in tandem and the staff was aware of the purpose of the orders. Moreover, according to Petitioner, after the change in Resident 3's Coumadin dosage on October 10, 2000, even though Resident 3 received 18 mg of Coumadin, instead of the prescribed 17.5 mg, during the three week period between October 10, 2000 through November 1, 2000, the additional 0.5 mg caused no harm to Resident 3 and did not have the potential for even minimal harm. P. Br. at 5.

I find the evidence submitted by the parties on this issue to be confusing. Although the MARs were not explained by either party, I reviewed the MARs submitted by CMS and from which the surveyors apparently determined that Resident 3 received too much Coumadin in October 2000. See, CMS Ex. 4, at 6, 7 and 8. The first sheet, CMS Ex. 4, at 6, indicates that 2 mg of Coumadin were administered at 4 p.m. every day except on Friday until October 10, 2000. The second sheet - CMS Ex. 4, at 7 - indicates that 3 mg. of Coumadin were administered at 4 p.m. by "EW" for the four Fridays after September 20th, which includes the time period after the order had been changed on October 10, 2000 to 2.5 mg daily. The third sheet - CMS Ex. 4, at 8 - indicates that 2.5 mg of Coumadin were administered to Resident 3 every day after October 10, 2000, when the order was changed except for October 13 and 20, 2000. The medication administration on the third sheet is often initialed by the same "EW" as initialed the second sheet. Both the second and third sheets are initialed for the date October 27, 2000. One could certainly infer that Resident 3 received 3.0 mg too much Coumadin on that date, but the logical inference is that Resident 3 received only .5 mg too much on October 13 and 20, 2000. Surveyor Edwards, nonetheless, in her declaration attested that, ". . . the MAR revealed that each Friday for three weeks in a row in October, 2000, facility staff administered more than twice the prescribed dosage of Coumadin." Except for October 27th, Surveyor Edwards' declaration does not accord with either the SOD or the MARs.

I find, therefore, that CMS has made a prima facie case that Resident 3 received .5 mg too much Coumadin on October 13 and 20, 2000, and that she received 3 mg over the prescribed amount on October 27, 2000.

In response, Petitioner submitted the declaration of Janice Somers, an R.N. and nursing consultant for Britthaven. She said she reviewed the medical record regarding the surveyor's allegation that Resident 3 received .5 mg more of Coumadin than was ordered by her physician. She added that an additional .5 mg of Coumadin did not have the potential for minimal harm. Somers Declaration, at para. 7. Petitioner also submitted the declaration of Todd King, a licensed pharmacist and the Director of Clinical Services for Britthaven. Mr. King attested that an additional .5 mg of Coumadin each week would and did not have even the potential for minimal harm to the resident. King Declaration, at para. 7.

In light of CMS's failure to submit any rebuttal to the Somers and King declarations, I find that Petitioner submitted sufficient evidence for me to conclude that an additional .5 mg per week of Coumadin did not have the potential for minimal harm to Resident 3. Petitioner, however, does not deny that Resident 3 received 3 mg too much Coumadin on October 27, 2000 and did not even address the potential for harm posed by administering more than twice the daily dose on that date. Unrebutted is Surveyor Edwards' affidavit that "[t]he facility's failure to administer [Coumadin] correctly created a risk of hemorrhage. Edwards Declaration, at para. 18. Moreover, my difficulty in interpreting Petitioner's MARs for the period at issue suggest the Petitioner's methods for transcribing Resident 3's prescriptions created a risk for inaccurate administration of the drugs.

I conclude, therefore, with respect to Resident 3, Petitioner did not provide necessary services for her highest practicable well-being.

Based on the evidence for the above-described residents, I can only conclude that Petitioner failed to provide services necessary for them to attain their highest practicable physical and mental well-being. Petitioner did not show that it would have been impractical to assure that Resident 1 received an x-ray sooner than she did. Earlier results from an x-ray of Resident 1 would likely have resulted in a higher level of treatment given to Resident 1 between the days of November 17 and November 22. Similarly, Petitioner could have attempted to determine the reason for Resident 2's apparent weakness much sooner than it did. A resident with cognitive impairments must be given a higher degree of attention to possible pain because pain could signify to the facility a previously unknown physical problem. Additionally, Petitioner did not maintain its medication administration records in such a fashion that would have ensured the administration of the correct dosage of medications. The greater weight of the evidence, therefore, supports a finding that Petitioner was not in substantial compliance with 42 C.F.R. 483.25.

2. Petitioner failed to comply with the requirement as set forth at 42 C.F.R. 483.25(h)(2).

Tag F324

Section 483.25(h)(2) of 42 C.F.R. requires a facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. I find that, with respect to Resident 2, Petitioner did not provide adequate supervision and assistance devices to prevent accidents.

Resident 2

Resident 2 suffered from Parkinson's Disease and dementia and, as mentioned previously, both Parkinson's and dementia are risk factors for falls. CMS Ex. 1, at 2; Edwards Declaration. Between September 14 and December 9, 2000, Resident 2 was documented as falling nine times at the facility. CMS Ex. 1, at 5. A fall on December 9, 2000 resulted in Resident 2 breaking her hip which required hospitalization and surgery. CMS Ex. 1, at 2; CMS Ex. 3, at 4. Upon readmission to the facility on December 18, 2000, Resident 2 fell four more times by December 26, 2000. CMS Ex.1, at 6.

CMS argues that "Resident 2 did not receive appropriate or adequate care planning to prevent falls, either before or after the hip fracture and resulting hospitalization." CMS Br. at 6. According to CMS, the facility's care plan, dated October 5, 2000, purported to address falls, but the approaches listed were inappropriate and ineffective due to Resident 2's cognitive impairments. Providing a low bed is an approach commonly used by facilities to prevent injuries to residents at risk for falling out of bed or falling while attempting to get out of bed. Edwards Declaration, at para. 13. However, alternative approaches, such as Resident 2's daughter's request of providing a low bed to prevent further falls, were not attempted by the facility as they should have been, CMS alleges. CMS Ex. 1, at 5-7.

Petitioner counters CMS's assertion that not enough was done to prevent falls by pointing out that the facility identified Resident 2 was at risk for falls through the Comprehensive Care Plan of October 5, 2000. P. Ex. 6, at 3-7. As a result, Petitioner explains that several steps were taken to reduce the probability of Resident 2 falling. The use of a merry walker and a physical therapy evaluation were two such measures taken by the facility to prevent falls by Resident 2. Id. (7) Petitioner also maintains that falls by Resident 2 that occurred after December 9, 2000, the date of the resident's hip surgery, should not be an issue because they were not mentioned in CMS Form 2567. (8)

The Board has expressed in several cases the standard to be applied when considering alleged deficiencies of 42 C.F.R. 483.25(h)(2). The regulations do not impose strict liability on a facility for accidents that a resident may sustain. See Koester Pavilion, DAB No. 1750 (2000). A facility is obligated, nonetheless, to take measures that are designed, to the extent that is practicable, to assure that residents do not sustain accidents that are reasonably foreseeable. Woodstock Care Center, DAB No. 1726 (2000), aff'd Woodsock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). The regulations do not require that a facility use any particular system to prevent accidents. Using an outcome-oriented approach, facilities have the flexibility to use a variety of methods, but they are responsible for achieving the required results. Woodward Hills Nursing Center, DAB CR991 (2003).

Resident 2 fell seven times between the time Petitioner developed her care plan of October 5, 2000 and the time she fell and broke her hip on December 9, 2000. CMS Ex. 3, at 4. It should have been obvious to Petitioner that the care plan adopted for Resident 2 was not working. I find that once Resident 2 had shown a risk for falling, the facility had an obligation to do everything practicable to keep her safe from further falls. Petitioner failed to submit evidence that additional practicable measures to better ensure Resident 2's safety were unavailable. Several of Resident 2's falls occurred when she tried to get out of bed. Yet, Petitioner submitted no evidence that it considered switching her to the use of a low bed or placing soft mats beside her bed. Certainly, once Resident 2 broke her hip, new and more aggressive measures should have been taken to prevent Resident 2 from falling again. I find it amazing that the facility made no changes in care planning to prevent further falls after this resident broke her hip. After Resident 2's hip surgery and readmission on December 18, 2000, Resident 2 fell on December 21, 24 and 26. At the end of December, Resident 2's daughter moved her to another facility. CMS Ex. 3 at 4 - 5.

The evidence is patent that Petitioner did not take reasonable precautions nor employ practicable measures to ensure that Resident 2 had adequate assistance devices and supervision to prevent falls, the risk for which was entirely foreseen by Petitioner. Therefore, I find that, as alleged by CMS, Petitioner was not in substantial compliance with 42 C.F.R. 483.25(h)(2).

The February Survey

B. CMS proved by a preponderance of the evidence that Petitioner was not in substantial compliance with Medicare participation requirements from February 14, 2001 through March 2, 2001.

1. Petitioner failed to comply with the requirements as set forth at 42 C.F.R. 483.10(b)(11) and 42 C.F.R. 483.25.

Tag F157 & Tag F309

Section 483.10(b)(11) of 42 C.F.R. requires that the facility must immediately inform the resident; consult with the resident's physician; and notify the resident's legal representative when there is significant change in the resident's physical, mental, or psychosocial status in either life-threatening conditions or clinical complications. Section 483.25 of 42 C.F.R. requires that the facility provide the necessary care and services so that each resident can attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. I find that Petitioner failed to notify Resident 4's physician when there was a significant change in her condition. I also find that Petitioner failed to provide necessary services to ensure Resident 4's highest practicable physical well-being. Resident 4, discussed below, incurred actual harm as a result of Petitioner's deficiencies.

Resident 4 (9)

Resident 4's diagnoses included Diabetes and End Stage Renal Disease (ESRD). P. Ex. 4, at 1. On February 11, 2001, Resident 4 developed a fever of more than 100 degrees Fahrenheit (100 F). P. Ex. 4, at 3. From 6:30 p.m. on February 11 until 2:15 p.m. on February 13, when she was transferred to the hospital, Resident 4's temperature was consistently over 100 F. P. Ex. 4, at 3-6. At or about 4 a.m. on February 13, 2001, Resident 4's physician was contacted. P. Ex. 4, at 4. That same afternoon Resident 4 was transferred to the hospital. P. Ex. 4, at 6.

CMS contends that the facility failed to adhere to accepted nursing standards as well as the Facility's own policy in assessing a resident's fevers. According to the Facility's policy, CMS alleges, a nurse was to contact a physician if a resident's fever was over 100 F and the resident was to be checked every 4 hours. Additionally, if a fever lasted more than 24 hours a physician was to be contacted according to the Facility's policy. CMS Ex. 6, at 15. CMS asserts that due to Resident 4's diabetic condition and her increased risk of infection, Resident 4's physician needed to be kept aware of any persistent fever, but was not kept aware. CMS Br. at 12, 13. Furthermore, CMS argues, the Facility failed to comply with its own policy in that it allowed 19 hours to pass without monitoring Resident 4's temperature. CMS Ex. 5, at 2; P. Ex. 4, at 3, 4.

The issue with respect to tag F157 is whether Resident 4's temperature of 100 F on February 11, 2001 was a "change of condition" that obligated the Facility to notify Resident 4's physician. According to regulation, such a change is a deterioration in health, mental, or psycho-social status in either life-threatening conditions or clinical complications. 42 C.F.R. 483.10(b)(11)(i)(B). To determine whether a "change of condition" has occurred, decision-makers have looked at whether there has been a change from the resident's baseline (Beverly Health & Rehabilitation - Springhill, DAB CR553, at 18 (1998), aff'd DAB No. 1696 (1999)); whether the nurses notes regarding the resident's condition increased in number (Fairview Haven DAB CR1175 (2004)); whether treatment or medications or the plan of care changed, or whether the situation had reached a point where it would not resolve without further intervention (Scallop Shell Nursing Home, DAB CR1171 (2004). In Lake City Extended Care Center, DAB No. 1658 (1998), the Board considered the situation in which a resident's increased temperature might be a change of condition. The Board concluded that the analysis must be done on a case by case basis and that it is not the magnitude of the resident's change in body temperature that defines a change in condition but whether the change in temperature signals a deteriorating condition.

Petitioner responds to CMS's allegation by asserting that Resident 4's increased temperature was not a change in condition. Petitioner contends that Resident 4 received regularly scheduled dialysis treatments and was administered Vancomycin for the infection to her dressing site. On January 29, 2001, Resident 4 had an elevated temperature, her physician was contacted and she was seen by her physician on January 30, 2001. Petitioner continues by stating that the elevated temperature that Resident 4 had between February 11 and 13 was "not the onset of a new condition" but a continuation of the condition that Resident 4's physician first diagnosed on January 29, 2001. P. Br. at 7, 8. Petitioner also explains that the facility gave Resident 4 Tylenol to reduce her fever and that when the fever persisted, Resident 4's physician was contacted. P. Reply, at 4.

Based on my review of the evidence, I find the following. In addition to diabetes and ESRD, Resident 4 had hypertension, peripheral vascular disease, multi-infarct dementia and had an above-the-knee amputation of the right leg and an at-the-knee amputation of the left leg. Resident 4 also had a history of fevers. P. Ex. 4, at 1. She had been discharged to the hospital on January 9, 2001 and was returned to the Facility on January 16, 2001. She had a catheter exit site infection upon her return to the Facility. Id. Petitioner's staff noted that she had a temperature of 100.4 F on January 29th and requested that her physician see her. P. Ex. 4, at 2. Resident 4 was seen by her physician on January 30, 2001. In addition to an order to change Resident 4's medications (the exact change and medications are unclear from the exhibit), the physician appears to have ordered a blood draw to rule out sepsis at a graft site and/or to rule out bronchitis or a urinary tract infection. Id. About one week later, on February 7th, Resident 4's temperature was noted to be 97.6 F and 99.0 F. Similarly on February 8th, the resident's temperature was noted to be 97.9 F and the resident had tolerated a trip out for dialysis. P. Ex. 4, at 3. Resident 4's temperature on February 9th was noted to be 98.2 F and 99.4. F Id. On February 10th, Resident 4's temperature was 97.5 F and, in the evening, 98 F. On February 11, 2001, however, at 6:30 in the morning, Resident 4's temperature had risen to 100.8F. The staff noted no signs of distress or pain. Later in the morning, at 11:30, Resident 4's temperature was 100.9 F, but the resident denied pain or discomfort. Id. Resident 4 was given Tylenol at 5:30 p.m., after which her temperature decreased slightly to 100.5F. But by 10:30 p.m., her temperature had risen to 101.2 F. P. Ex. 4, at 4. As explained below, I find it was at this time that Resident 4's physician should have been contacted.

The next day, the first nurse's note for Resident 4 on February 12th, indicates that her temperature was 101.9 F and after a Tylenol suppository, decreased slightly to 100.8 F. Her temperature at 4 p.m. was 101.2 F followed by more Tylenol; at 8:30 p.m., her temperature continued to be over 101 F, followed by more Tylenol. Resident 4's temperature was clearly resistant to the Tylenol. The nurse recommended that Resident 4's temperature be checked again at 10:00 p.m. and 11:30 p.m., and if the temperature persisted, the staff should contact Resident 4's physician. Id. The next morning, at around 3:00 a.m., on the 13th, Resident 4's temperature had risen to 102.7 F. The charting nurse notes that Resident 4's temperature had continued to increase without relief from Tylenol and her physician was called. The physician ordered an intramuscular injection of Rocephin and a chest x-ray, and asked the staff to call him later in the morning. The injection was given at 3:45 a.m. Resident 4's temperature was still 101.2 F at 5:00 a.m., and remained at that level until 7:00 a.m. At 7:15 a.m., the staff paged a nurse practitioner regarding Resident 4's condition. Fifteen minutes later, the staff phoned for the doctor on call. Id. The staff received a call back from Resident 4's physician at 8:05 a.m., who instructed the staff to call Resident 4's nephrologist to determine whether Resident 4 should be evaluated or simply hospitalized. The nephrologist decided to evaluate Resident 4 at the dialysis center. Unfortunately, Resident 4's temperature continued to rise and at 9:00 a.m., it reached 103.7 F and the staff again contacted the nephrologist, who determined that Resident 4 should be sent to the hospital. Resident 4 was transported to the hospital at around 10:30 a.m. P. Ex. 4, 6.

For several reasons, I find that Petitioner's staff should have contacted Resident 4's physician on February 11, at least by 10 p.m., rather than wait until February 13, 2001. Resident 4 experienced a change in condition. Between January 30 and February 11, Resident 4's temperature had normalized somewhat by staying under 100 F. P. Ex. 4, at 3. When Resident 4's temperature elevated to 100 F and above, it must be viewed as a change from her baseline. Moreover, Resident 4's temperature was only slightly responsive to Tylenol. The nurses notes show increasing attention to Resident 4's temperature indicating an awareness that Resident 4's condition had deteriorated and that an elevated temperature can be a serious condition. The increasing use of Tylenol for Resident 4 shows that her treatment and care management had changed. Further, once Resident 4's physician was contacted, he prescribed an immediate intramuscular injection, indicating that Resident 4's condition was unlikely to get better without quick intervention, indicating a deteriorating condition.

Surveyor Edwards attested that diabetics are particularly susceptible to infections of all sorts. Because of this resident's fragile status, Petitioner's nursing staff needed to ensure that her physician be aware of persistent or high fevers. Edwards Declaration, at para. 22. She also averred that Resident 4 was at risk for dehydration from persistent fever and yet when a patient with ERSD suffers fever, restorative hydration must be managed more closely, because of the patient's diminished or absent kidney function. Id., at para. 23.

Petitioner's own policy highlights the seriousness of a resident's temperature rising above 100 F in that special orders must be adhered to. Petitioner's policy was to contact the physician if a resident had a fever of more than 100 F. CMS Ex. 6, at 15. If the fever persisted more than 24 hours, the physician was to be notified according to Petitioner's policy. Resident 4 first had a temperature over 100 F on February 11, 2001 at 6:30 a.m. At 10:45 p.m. on February 12, 2001, Petitioner's staff still had not contacted Resident 4's physician. Only a notation was made that a doctor should be contacted if the resident's fever persisted. CMS Ex. 6, at 9. A physician was not called until February 13, 2001 at 4 a.m. Id. at 10. The staff waited almost 48 hours, much longer than the time period indicated in Petitioner's policy. Petitioner failed to follow its own guidelines.

Surveyor Edwards attested that Petitioner's failure to contact Resident 4's physician created the potential for more than minimal harm. Edwards Declaration, at para. 22, 23. Petitioner provided no rebuttal evidence that no harm could result from a failure to notify a resident's physician when the resident has a persistent fever over 100 F.

One of a resident's rights afforded by the regulations is to have the facility contact a physician when the resident has experienced a significant change in condition. 42 C.F.R. 483.10(b)(11). With respect to Resident 4, Petitioner failed to comply substantially with this federal requirement.

Tag F157 and Tag F309 are both cited at times for a deficiency on the same set of facts. Lake City Extended Care Center, DAB No. 1658 (1998) (failure to report elevated temperatures cited under Tag F309). When a facility fails to notify a physician as required by 42 C.F.R. 483.10(b)(11), the facility inherently fails to provide necessary services to that resident. Therefore, I find that Petitioner failed to provide necessary physician services to Resident 4 and the failure created a potential for more than minimal harm. This supports my finding that Petitioner also failed to comply substantially with 42 C.F.R. 483.25 (Tag F 309).

The March Survey

C. CMS proved by a preponderance of the evidence that Petitioner was not in substantial compliance with Medicare participation requirements from March 3, 2001 through March 8, 2001, and March 9, 2001 through April 25, 2001. CMS also proved that this deficiency presented immediate jeopardy between March 3, 2001 and March 8, 2001.

1. Petitioner failed to comply with the requirements as set forth at 42 C.F.R. 483.10(b)(11).

Section 483.10(b)(11) of 42 C.F.R. requires that the facility must immediately inform the resident; consult with the resident's physician; and notify the resident's legal representative when there is significant change in the resident's physical, mental, or psychosocial status in either life-threatening conditions or clinical complications. I find that Petitioner failed to notify Resident 1's physician when there was a significant change in his condition.

Resident 1 (10)

Resident 1 had diagnoses of, inter alia, cardiac dysrhythmia, cardiovascular disease, chronic atrial fibrillation, and hypertension. See P. Ex. 2, at 21; see CMS Ex. 7, at 2. Resident 1 was assessed by the Facility as having moderate cognitive difficulties but he could make himself understood with good speech clarity and he could usually understand others. P. Ex. 3, at 9-14.

CMS contends that Resident 1 complained to the Facility's staff of symptoms easily recognizable as a heart attack. CMS Br. at 19. Resident 1's diagnoses of heart-related problems were all risk factors for heart attacks and the Facility's staff simply did not recognize this, CMS alleges. CMS Br. at 15; see Edwards Declaration, at para. 25. According to CMS, Resident 1 pleaded with the Licensed Practical Nurse (LPN) on duty to notify his physician or to call an ambulance to take him to the hospital. The LPN refused to do either and Resident 1 died shortly thereafter on March 5, 2001. CMS Ex. 9, at 4. CMS also contends that rather than call a physician or ambulance, the staff LPN administered nitroglycerin to Resident 1 without a physician's prescription or consult and without documenting the dosing in Resident 1's records. CMS Ex. 9, at 11. On March 7, 2001, the LPN who administered nitroglycerin to Resident 1 was suspended and she was later terminated from employment at the facility. See CMS Ex. 9.

Petitioner contends that contrary to the survey report, Resident 1 did not have chronic chest pain and did not complain of continuous chest pain during the time period at issue. P. Br. at 9. Petitioner maintains that Resident 1 experienced what he described as indigestion and that this problem was relieved after medication was administered. Id. According to Petitioner, Resident 1 did not have a change of condition, his vital signs remained stable throughout, and no physician notification was necessary. Id. at 10.

Petitioner's nurses' notes report the following. At 11:10 p.m., on March 2, 2001, Resident 1 complained of pain in his chest and right arm. MB, the LPN on duty that evening, noted his respiration as normal, his heart rate regular, and that he had no shortness of breath or weakness. Resident 1 requested nitroglycerin and LPN MB gave it to him. CMS Ex. 10, at 1-3; P. Ex. 2, at 28. Later that night, around midnight, Resident 1 again complained of chest pain. LPN MB noted that Resident 1's breathing and heart rate were even and unlabored. Resident 1 requested and he again was given nitroglycerin for his complaint by LPN MB. Id. The next morning, at 10:15 a.m. on March 3, 2001, someone on the Facility's staff called Resident 1's physician and a physician's order was received and oxygen was administered to Resident 1 at 2 p.m. Rhonchi had been noted in his lung lobes bilaterally. Resident 1 was still complaining of neck and chest pain. Id. At 3 p.m. on March 3, 2001, Resident 1 again complained of neck and chest pain. He added indigestion to his complaints and he was given Maalox. Id. At 5:00 a.m. the next day, March 4, 2001, LPN MB charted that Resident 1's color was good, his breathing was unlabored and he had voiced no complaints. Id. At 9:30 a.m., Resident 1 again complained of chest, neck, abdominal pain and indigestion. He was given Tylenol and Maalox. Id. Later , at 10:30 p.m., LPN MB charted that Resident 1 told the nurse on duty that he "did not feel well." She also charted that his heart rate was strong, his respirations unlabored, and his color good. More Maalox was given to Resident 1. Id. That night, just before midnight, another staff nurse reported that Resident 1 was complaining of shortness of breath and she heard rhonchi upon listening to his lungs. This staff nurse returned to the nurses station to receive a report from the nurse who was leaving her shift. About 30 minutes later, the hall attendant came to the nurses station and reported that Resident 1 was no longer breathing. At 12:40 a.m. on March 5, 2001, Resident 1 was pronounced dead. Id.

Other record evidence tells a slightly different story. For example, Petitioner's administrator later spoke with John M, R.N., who was on duty the night of March 3, 2001. He reported that LPN MB had asked him to look at Resident 1 that night.

[Nurse John M] said that [Resident 1] stated to him that he was having chest pain on a scale of one to ten it was a 10. John asked [Resident 1] if he was having nausea and he said yes about an hour ago he felt nauseous. John asked him if [Resident 1] had been sweating and he said yes about an hour ago. John then went and told [LPN MB] what [Resident 1] had said regarding his health and LPN MB told him [Resident 1] was not having these symptoms.

CMS Ex. 9, at 15. Petitioner provided little evidence of what symptoms were actually reported to the physician on the morning when the physician was contacted. CMS Ex. 9, at 5, 7. The physician prescribed oxygen apparently to deal with Resident 1's shortness of breath.

Other statements are instructive for what occurred to Resident 1. Resident 1's roommate's wife reported to several staff members that when she had been in Resident 1's room during the evening of March 4, 2001, Resident 1 was begging for the nurse to please get him a doctor or an ambulance because his chest was killing him and the nurse responded that she had given him all the meds she could and that was all she could do. The roommate's spouse also said that when she left the room at 10:30 p.m. that night, Resident 1 was still begging for help and he told the spouse that if someone did not get him some help, he knew he was going to die. CMS Ex. 9, 1-2, 4 .

Later when the third shift nurse came on duty at about 11:10 p.m. and was standing at the nurses station, Resident 1's call light came on. The off-going nurse reported that Resident 1 had been short of breath all day and the staff had put him on oxygen. The on-coming nurse got her stethoscope and went to his room.

[Resident 1] said to me "You are the oncoming nurse? I replied, "yes." He said to me, "Something has got to be done." I told him that I would call the MD and come let him know what was said. I went back to the desk to finish getting report and to do the narcotic count. By the time I had gotten report and thought I would go ahead and call the MD, the CNA came up to the nurses station and said, "I think [Resident 1] is dead."

CMS Ex. 9, at 5.

I find that chest pain along with arm, neck and abdominal pain are classic signs of a heart attack and are red flags that should have prompted immediate and continuing notification of Resident 1's physician. Edwards Declaration. Petitioner argues that Resident 1 was primarily complaining of indigestion that was relieved by the medication given to him. The evidence is to the contrary. Even the nurses' notes document Resident 1's persistent chest pain complaints. Moreover, RN John M quite particularly told LPN MB that Resident 1 was having symptoms of a heart attack and yet neither staff member contacted a physician about those symptoms. Rather LPN MB denied that Resident 1 was having those symptoms even though she had given Resident 1 nitroglycerin - which is used for chest pain related to the heart, not the lungs.

Petitioner objects to CMS's repeated references to the fact that LPN MB administered nitroglycerin to Resident 1 when there was no outstanding physician's prescription for nitroglycerin. I find it relevant that LPN MB gave Resident 1 nitroglycerin not so much because LPN MB administered the drug without a physician's order but because Resident 1's request for it should have alerted LPN MB to the fact that Resident 1 was dealing with a heart problem.

Resident 1's physician was contacted on March 3, 2001; however, in no way was Resident 1's actual condition ever conveyed to his physician between the dates of March 2 through March 5, 2001. See P. Ex. 2 at 28; CMS Ex. 7, at 4. Furthermore, in an interview with Resident 1's physician on March 12, 2001 he stated to State agency surveyors that "his expectation of the facility staff is to notify [him] of continued chest pain." CMS Ex. 8, at 11. During a period of three days, March 2 to March 5, 2001, Resident 1 had continued chest pain and Resident 1's physician was only contacted once early on and was not again contacted as Resident 1's complaints persisted. P. Ex. 2 at 23, 28.

The preamble to 42 C.F.R. 483.10, the regulation at issue, states that:

The resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility.

I find that Petitioner's staff's refusal to call a physician when Resident 1 asked the staff to do so deprived him of a dignified existence (his need to beg for help), self-determination (his desire to be seen by a physician or transported to the hospital), and communication with and access to persons and services outside the facility (his physician).

The subpart of the regulation at 42 C.F.R. 483.10(b)(11)(ii)(B) which was cited as Petitioner's deficiency requires a facility to consult with the resident's physician when there has been a significant change in the resident's physical, mental, or psychosocial status. I find that Resident 1 experienced a significant change in condition in that his baseline condition had changed. See Beverly Health & Rehabilitation - Springhill, DAB CR553, at 18 (1998), aff'd DAB No. 1696 (1999). Petitioner failed to present any evidence that Resident 1 had previously had persistent complaints of chest pain along with arm, neck and abdominal pain and indigestion that had been ameliorated with Tylenol and Maalox. When the staff did contact Resident 1's physician, the staff did not adequately convey Resident 1's symptoms because the Facility's staff failed to recognize the symptoms of a heart attack. The staff failed to provide further information to Resident 1's physician over the course of the next day even though his symptoms persisted. The evidence shows, therefore, that Petitioner failed to contact Resident 1's physician when there was a significant change in his condition. This failure deprived Resident 1 of his right to essential services and, perhaps, his life. Essentially, the staff ignored the fact that Resident 1 had a significant change in his condition. It is clear that Resident 1 was cognizant of his surroundings, could discuss how he felt and he was not totally demented. Therefore, Resident 1's complaints should have been taken seriously and a physician should have been notified by the facility pursuant to 42 C.F.R. 483.10(b)(11).

Petitioner pointed out in its brief that Resident 1 was admitted with a "do not resuscitate" order. P. Br. at 9. Petitioner's reference to Resident 1's "do not resuscitate" order is entirely misplaced. This type of order is only to be implemented at the time of apparent death and at no point until the early morning of March 5, 2001 was there any time that this order should have even been considered by the Facility.

D. CMS's assessment of immediate jeopardy is not clearly erroneous.

Immediate jeopardy occurs when 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 the resident. Given CMS's expertise in determining scope or severity, I cannot change CMS's assignment of immediate jeopardy unless that assignment is clearly erroneous. I am constrained by 42 C.F.R. 498.60(C)(2), which provides that the ALJ upholds "CMS's determination as to the level of the noncompliance of" a skilled nursing facility "unless it is clearly erroneous." See also 42 C.F.R. 498.3(d)(10).

In the case at hand, CMS proved that Petitioner's noncompliance with federal requirements did indeed cause actual harm, and likely death, to Resident 1. Petitioner provided no evidence that Resident 1 had ever lied about, exaggerated or misunderstood his symptoms. The evidence shows that Resident 1 had a right to be listened to when he voiced his complaints but in many ways his complaints were either dismissed or ignored. Additionally, Petitioner's staff failed to recognize very common symptoms of an individual who is having a heart attack. The staff's mishandling of these classic symptoms played a significant part in Resident 1's physician not being kept informed of Resident 1's significant change in condition. Moreover, the staff's inaction when presented with these symptoms placed the Facility's other residents in jeopardy of serious harm, injury or death as well. Petitioner's failure to contact Resident 1's physician resulted in substantial noncompliance with federal regulations and the severity of the result of Petitioner's failure can certainly be considered immediate jeopardy. Therefore, I find that CMS's determination of immediate jeopardy is not clearly erroneous.

E. Length of immediate jeopardy determined correctly by CMS.

CMS determined that immediate jeopardy at Petitioner's facility lasted from March 3, 2001 through March 8, 2001, and assessed a CMP accordingly. Petitioner contends that even if the finding for immediate jeopardy is upheld, the period for immediate jeopardy should be shorter. P. Br. at 11. First, Petitioner proposes that since Resident 1's physician was contacted on the morning of March 3, 2001, that date should not be considered as part of the time that immediate jeopardy was assigned. Second, Petitioner contends that March 5, 2001 was the last day of employment for LPN MB, who had administered nitroglycerin without a prescription, and, therefore, immediate jeopardy should have ended on that date. Third, Petitioner argues, in the alternative, that because March 7, 2001 was the date that LPN MB was suspended, immediate jeopardy should certainly not go beyond that date. Id.

CMS responds that immediate jeopardy should run until the Facility put in place a training program for its staff to understand the signs and symptoms of a heart attack. CMS Br. at 20. The date that the Facility put this type of training program in place was March 8, 2001. See CMS Ex. 7, at 4. I agree with CMS. While, it is true that the Facility's staff contacted Resident 1's physician on March 3, 2001, Petitioner's staff did not recognize the symptoms of heart attack and the importance of relaying those symptoms to the physician. Instead, Petitioner's staff repeatedly interpreted Resident 1's physical problems as those of indigestion and breathing difficulties. If Resident 1's condition of his continuing chest, neck, arm, and abdominal pains in addition to his shortness of breath had been accurately expressed to the physician, the physician likely would have given entirely different orders. Therefore, immediate jeopardy must include March 3, 2001.

With respect to the end period of the immediate jeopardy, as I noted previously, I do not find that LPN MB's administration of nitroglycerin without a prescription to be the relevant point of immediate jeopardy. All of Petitioner's staff who dealt with Resident 1 during March 3 to 5, 2001, including several staff nurses, missed their obligation to report to Resident 1's physician about his changed condition. Even at the point just before Resident 1 died, one of Petitioner's nurses did her narcotic count before calling his physician as he had asked her. Moreover, Petitioner provided no proof about how and what the staff was taught beginning on March 6, 2001. CMS has determined that March 8, 2001 is the day that training about warning signs of a heart attack was implemented by the Facility. CMS Br. at 20. I, therefore, find that immediate jeopardy ended on March 8, 2001, as determined by CMS.

F. The remedies imposed by CMS on Petitioner for its noncompliance found during the December survey, and the February and March surveys, were reasonable.

A basis exists to impose CMPs against Petitioner of between $50 per day to $3,000 per day, for each day of the period beginning on December 28, 2000 through February 13, 2001, from February 14, 2001 through March 2, 2001, and March 9, 2001 through April 25, 2001, in addition to CMPs against Petitioner of between $3,050 per day to $10,000 per day for each day of the period beginning March 3, 2001 through March 8, 2001 due to an immediate jeopardy finding. The ALJ is to make a de novo review of the factors listed in 42 C.F.R. 488.438(f) to evaluate whether a CMP is within a reasonable range.

One factor I can consider when reviewing CMPs is the facility's history of non-compliance, including repeat deficiencies. Petitioner has a poor compliance history, although interspersed with a good survey. A June 1998 survey of the facility revealed noncompliance with seven different requirements, of which each was found to have harmed residents. CMS Ex. 12, at 1. Also, a more recent survey in July 2000 listed multiple violations including one that was found to have harmed residents. Id. Moreover, even though Petitioner was found deficient in contacting physicians at the appropriate time in the February survey, Petitioner's March immediate jeopardy deficiency was for the same violation. Given application of this factor, a CMP ($200 or $100 per day CMP) is at the lower end of permissible amounts for non-jeopardy deficiencies ($50 to $3,000 per day) and does not argue for a lower CMP. The jeopardy level CMP assessed against Petitioner ($7,000 per day) is at the mid-point of applicable CMPS ($3,050 - $10,000 per day) and is also not unreasonable, given this factor.

Another factor for consideration is the Facility's financial condition. Petitioner provided no evidence that its financial condition will be affected substantially by the payment of the CMPs or that it could not pay the CMPs as assessed. Petitioner cannot avail itself of this factor in arguing that the CMP is unreasonable.

Pursuant to 42 C.F.R. 488.404, an ALJ may consider the scope and severity of the noncompliance of a facility. In determining the seriousness of the deficiencies, whether the deficiencies constitute actual harm must be assessed. 42 C.F.R. 488.404(b)(iii) and (iv). In examining the evidence, the following incidents resulted in very clear actual harm to the residents: Resident 2 breaking her hip and Resident 1 dying from a heart attack. The facility's culpability, can be defined as, inter alia neglect, indifference, or disregard for resident care, comfort or safety. The Facility's staff refusing to contact a physician (for Resident 2 and Resident 1) or to send a resident to the hospital when he asked for something to be done (Resident 1) shows total indifference. Given these factors, I find the CMPs very reasonable.

Petitioner contends that on top of the "outrageous" civil money penalty, the facility was denied payments for new admissions for nearly two months and that this loss should be taken into account when considering the reasonableness of the CMPs. P. Reply, at 7. Petitioner points out that the denial of payment for new admissions began on or about March 29, 2001, and continued through May 23, 2001. Because the Facility was cited for numerous deficiencies during the April 26, 2001 survey that were subsequently rescinded during informal dispute resolution, the denial of payment for new admissions should have ended on April 26, 2001 instead of May 23, 2001. Petitioner proposes that because the substantial penalty of denial of payment for new admissions cannot be recovered, this fact should mitigate for a lower CMP. Id. While I understand Petitioner's argument, this fact is simply not one of the factors prescribed by regulation that I can consider in making a determination on the reasonableness of the assessed CMPs. Further, looking at all of the factors I can consider, such as the seriousness and repeated nature of the deficiencies, I find that the assessed CMPs are in accord with the purpose and intent of the regulations; that is, to protect Medicare beneficiaries, and are, therefore, reasonable.

IV. Conclusion

I sustain CMS's findings of noncompliance for all three surveys; I sustain CMS's assessment of immediate jeopardy regarding the March survey. Immediate jeopardy is not clearly erroneous. I also sustain the length of immediate jeopardy assessed by CMS. Finally, I find all of the amounts of CMPs to be reasonable.

JUDGE
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Anne E. Blair

Administrative Law Judge

FOOTNOTES
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1. The resident identified as "Resident 1" in the December survey is a different resident than the individual identified as "Resident 1" in the March survey.

2. Resident 1 had been diagnosed with rheumatoid arthritis with deformities, bilateral total knee replacements and organic brain syndrome. CMS Ex. 1, at 1.

3. Contrary to Petitioner's unsupported argument, a surveyor interviewed a staff nurse on December 28, 2000, and was told that it takes time for the physician to fax orders back. This staff nurse told the surveyor she had been off work for a few days and when she returned she called the doctor. The x-ray order is dated November 21, 2000, and was signed at 3:00 p.m. that day. This suggests no one else on staff contacted Resident 1's physician between November 17 and 21, 2000. CMS Ex. 1, at 1-2; CMS Ex. 3, at 26; P. Ex. 5, at 1.

4. On November 22, 2000, after Resident 1's x-ray report, Darvocet, a different pain medication, was prescribed. P. Ex. 5, at 1.

5. Petitioner's compliance under 42 C.F.R. 483.25(h)(2) is discussed in the next Section .

6. It appears Resident 2 was given a physical therapy evaluation on December 12, 2000. P. Ex. 6, at 6. Neither party discusses this evaluation. Petitioner does not indicate whether the evaluation was in response to an earlier request on November 10, 2000 (P. Ex. 6, at 3) or whether the evaluation was done because of Resident 2's newly noticed weakness. I infer the former because the treatment was to include gait training, transfers, bed mobility, and therapeutic exercises (P. Ex. 6, at 6) and because, if the latter, Petitioner surely would have referred to it in this proceeding as a step it took to respond to Resident 2's weakness. The physical therapist found Resident 2 had pain [with bending ] her right hip and took three steps before nearly collapsing. Id., at 7. I question whether Petitioner would have requested an x-ray for Resident 2 even on December 12 had the physical therapist not noticed Resident 2's pain in her right hip. I also question whether Resident 2 suffered unnecessary pain as a result of the evaluation.

7. As noted previously, although a physical therapy evaluation was requested on November 10, 2000, there is no evidence that the evaluation was done until December 12, three days after Resident 2 broke her hip. Footnote 6, supra.

8. Petitioner is incorrect. Resident 2's falls of December 21, 24 and 26, 2000, are referenced in CMS's SOD. CMS Ex. 1, at 6.

9. Tag F157 and Tag F309 both rely upon the same facts; therefore, I will discuss these tags concurrently.

10. The resident identified as "Resident 1" in the March survey is a different resident than the individual identified as "Resident 1" in the December survey.

CASE | DECISION | JUDGE | FOOTNOTES