CASE | DECISION | JUDGE | FOOTNOTES

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


SUBJECT:

Fairfax Nursing Home,

Petitioner,

DATE: March 22, 2001
                                          
             - v -

 

Health Care Financing Administration.

 

Docket No.C-97-406
Decision No. CR753
DECISION
...TO TOP

Fairfax Nursing Home (Petitioner) requested a hearing in this case on May 8, 1997, pursuant to section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. §§ 488.408(g), 498.3(b)(12),(13).(1)

Petitioner is a skilled nursing facility participating in Medicare and Medicaid. On April 8, 1997, the Illinois Department of Public Health (IDPH) completed standard, extended, and Life Safety Code surveys at Petitioner to determine if it was in compliance with the federal requirements for nursing homes participating in Medicare and Medicaid.

That visit resulted in a finding that Petitioner was not in substantial compliance with participation requirements, and that the conditions in Petitioner's facility constituted immediate jeopardy to resident health and safety. As a result, IDPH notified Petitioner that it would recommend to the Health Care Financing Administration (HCFA) that it impose specific remedies. HCFA concurred with the recommendation and, on May 7, 1997, it imposed the following remedies:

  • A civil money penalty (CMP) of $3,050 per day for each day of immediate jeopardy, effective December 20, 1996 and continuing through April 3, 1997; and a CMP of $50 per day, effective April 4, 1997 and continuing until attainment of substantial compliance or termination of the provider agreement.


  • Directed Inservice Training, effective May 22, 1997 for all licensed nursing and certified respiratory therapy staff caring for the ventilator and tracheostomy residents.


  • Denial of Payment for New Admissions, effective May 22, 1997.

HCFA subsequently determined that Petitioner was back in substantial compliance on May 15, 1997. HCFA imposed a CMP totaling $322,300, calculated as follows: a daily fine of $3,050 from December 20, 1996 through April 3, 1997 (a total of $320,250); and a daily fine of $50 from April 4, 1997 through May 14, 1997 (a total of $2,050). Petitioner does not contest any of the deficiencies which were the basis of the $2,050 CMP from April 4, 1997 through May 14, 1997. Petitioner's Readiness Report at 1. At issue is HCFA's finding of immediate jeopardy, which is the basis of the CMP imposed from December 20, 1996 through April 3, 1997.

A hearing was held before me in Chicago, Illinois, from May 31 through June 2, 2000. At the hearing HCFA offered 21 exhibits identified as HCFA Ex. 1 - 21. Petitioner did not object to HCFA Ex. 1 - 20, and I admitted them into evidence. Petitioner objected to HCFA Ex. 21. I overruled Petitioner's objection, and admitted HCFA Ex. 21 into evidence. Petitioner offered 20 exhibits identified as P. Ex. 1 - 20. HCFA did not object to P. Ex. 1 - 20, and I admitted them into evidence.

HCFA subsequently submitted a posthearing brief (HCFA Brief). Petitioner submitted a response brief (P. Response). Attached to Petitioner's response brief is a May 26, 1998 final order and decision issued by IDPH. I identify this document as P. Attachment 1. Petitioner argues that the IDPH decision is instructive because it shows that the facts of this case "did not rise to the state equivalent of an immediate jeopardy." P. Response at 20.

HCFA submitted a reply brief (HCFA Reply). Attached to HCFA's reply brief is a November 7, 2000 ruling issued by an Administrative Law Judge of this office. I identify this document as HCFA Attachment 1. HCFA argues that reliance on the IDPH decision would be misplaced, and it cites the attached ruling as support for the proposition that I should refuse to defer to State administrative findings made in State proceedings where HCFA was not a party.

The IDPH decision is not binding on me, and I accord it little weight. As HCFA points out, HCFA was never a party to the State proceedings and the State decision is the product of a different evidentiary record as well as different legal standards.

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 December 20, 1996 through April 3, 1997, Petitioner was not in substantial compliance at the immediate jeopardy level. Thereafter, and continuing through May 14, 1997, Petitioner admits that it was not in substantial compliance at less than the immediate jeopardy level of severity. I find further that HCFA is authorized to impose CMPs against Petitioner at the rate of $3,050 per day from December 20, 1996 through April 3, 1997, and at $50 per day from April 4, 1997 through May 14, 1997.

Applicable Law and Regulations

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

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

Pursuant to the Act, the Secretary has delegated to HCFA and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 488 provides that facilities which participate in Medicare may be surveyed on behalf of HCFA 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 provisions for long-term care facilities. 42 C.F.R. §§ 488.300 - 488.325. Under Part 488, a State or HCFA 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 continue until the date substantial compliance is achieved or the provider agreement is terminated.

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 terms "substantial compliance" and "immediate jeopardy" are defined terms in the regulations which govern participation of long-term care facilities in Medicare. "Substantial compliance" is defined 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. "Immediate jeopardy" is defined to mean:

a situation in which the provider's non-compliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

Id.

There are additional factors which the State and HCFA consider in determining where within a range of penalties, once the range is established, the amount of a CMP should be. These include the facility's:

1. history of noncompliance, including repeated deficiencies;

2. financial condition; and

3. culpability for the deficiencies.

42 C.F.R. § 488.438(f). Additionally, the State and HCFA may consider factors specified in 42 C.F.R. § 488.404. These include the relationship that a deficiency may have to other deficiencies and a facility's prior history of deficiencies.

The applicable burden of proof in a CMP case requires HCFA to prove a prima facie case that the facility has failed to comply substantially with one or more participation requirements. To prevail, a facility must overcome HCFA's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997); aff'd Hillman Rehabilitation Center v. United States, No. 98-3789 (GEB) (D.N.J. May 13, 1999). HCFA's determination that a deficiency constituted immediate jeopardy must be upheld unless the facility proves that the determination was clearly erroneous. 42 C.F.R. § 498.60(c)(2); Woodstock Care Center, DAB No. 1726, at 9 (2000).

The Act and regulations make a hearing before an Administrative Law Judge available to a long-term care facility against whom HCFA has determined to impose a CMP. Act, section 1128A(c); 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., 941 F.2d 678 (8th Cir. 1991).

Issues

1. Whether Petitioner was complying substantially with federal participation requirements on the dates HCFA determined to impose a CMP.

2. If it is established that Petitioner was not complying substantially with federal participation requirements, what was the level of non-compliance.

3. If non-compliance is established, whether the amount of the penalty imposed by HCFA is reasonable.

Findings and Discussion

Findings of fact and conclusions of law are stated below in italics. They are followed by a discussion of each finding.

1. Petitioner was not in substantial compliance with federal participation requirements from December 20, 1996 through April 3, 1997.

The applicable regulation at 42 C.F.R. § 483.25, entitled "Quality of care," provides:

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 or care.

As a corollary to this overarching requirement, 42 C.F.R. § 483.25(k) provides that the facility "must ensure" that residents receive proper treatment and care for "special services," including:

(1) tracheostomy care;

(2) tracheal suctioning; and

(3) respiratory care.

Below, I will discuss examples of failures by Petitioner to comply with the pertinent regulatory requirements mentioned above.

Resident number 10 (R10)

a. Petitioner failed to implement a policy concerning ventilator dependent residents, and, through its carelessness, brought about the premature demise of R10. This constitutes immediate jeopardy.

State surveyor findings

The findings of the State surveyors are set forth in a HCFA Form 2567. HCFA Ex. 1. In essence, the State surveyors found that the staff caring for R10 "did not follow guidelines/procedures/protocols in the provision of respiratory care, and that lack of adherence directly caused the death of R10." HCFA Ex. 1 at 21.

Discussion

The record shows that on December 20, 1996, R10 experienced an episode of respiratory distress and required care. Transcript (Tr.) at 135. She was completely dependent on a ventilator for breathing, as she could not do so on her own. Tr. at 138.

Respiratory therapists administered oxygen to the resident using a device known as an ambu-bag. This device allows an operator to manually force air into the lungs in order to promptly raise the oxygen saturation level of a resident to normal. During the process of "ambu-bagging," a respiratory technician disconnected the resident from the ventilator, and turned the machine off.(2) After manually elevating the resident's oxygen saturation level, the therapist reconnected R10 to the ventilator, but did not turn the machine back on. This left the resident without any oxygen supply. She died as a direct result. Tr. at 135 - 138; HCFA Ex. 12.

Ms. Patricia Benda, the Director of Nursing (DON), was notified at home that R10 had died under questionable circumstances. Tr. at 479 - 480. She went to the facility and inquired as to the facts surrounding the death of R10, and learned that the ventilator had been turned off when R10 was being administered respiratory therapy. Ms. Benda was unable to obtain information as to who turned the ventilator off from the two attending respiratory therapists, Brenda Harris and Michael Anderson. The latter, who was the last person in the room with the resident, initially denied turning off the ventilator. Tr. at 480 - 482.

The police were alerted and they came and took Mr. Anderson into custody. Under police interrogation, he stated that he "unconsciously" turned the ventilator off to silence its alarm while Ms. Harris was in the process of giving the resident manual respiratory therapy with an ambu-bag. The resident was returned to stable condition and everyone left the room. He was the last one out, and forgot to turn the ventilator back on. HCFA Ex. 12 at 7.(3)

Ms. Benda testified that Petitioner had a policy to the effect that the ventilator was never to be turned off unless the resident had been pronounced dead by a physician, or two registered nurses, or transferred to a hospital. Tr. at 484. If such a policy did exist, it appears to be an unwritten policy because no document containing that policy was produced at the hearing.

It was not until February 1997 that Petitioner developed a written policy for the care and treatment of ventilator dependent residents in respiratory distress; and it was not until the beginning of March 1997 that, after much deliberation, the policy was implemented. That policy, entitled "Nursing Guidelines for Ventilator Dependent Residents in Respiratory Distress," was developed in the aftermath of the tragic events of December 20, 1996, involving R10. P. Ex. 10; Tr. at 491 - 492.

The main purpose of those new guidelines was not only to ensure proper care and treatment for ventilator dependent residents who experienced respiratory distress, but also to provide monitoring for those whose respiratory distress symptoms had been relieved. Tr. at 510; P. Ex. 10.

Stabilized ventilator dependent residents were to be observed by a nurse and charted every fifteen minutes for up to an hour. The documentation would include vital signs, respiratory status, oxygen saturation levels, lung sounds, ventilator settings, level of consciousness, odor, color, and consistency of secretions, and comfort level of the resident. Any further respiratory distress noted during the monitoring period would warrant an immediate call to the attending physician, and continued observation and documentation throughout the shift, or until the resident stabilized or was transferred to a hospital. P. Ex. 10.

Ms. Benda, the DON, agreed that the policy adopted by the facility after the incident of December 20, 1996 embodied good nursing practices, and that R10 should have been monitored after apparently having been stabilized. Tr. at 502.

It is unequivocal, from the facts of this case, that Petitioner's carelessness was the direct cause of R10's death. Tr. at 489. The lack of due care is first evident from the act of turning the resident's ventilator off, and then from not monitoring the resident after she apparently had been stabilized. As stated by Ms. Benda in her testimony, such monitoring is good nursing practice. She testified that it "should be done on every resident that goes into any type of distress." Tr. at 502. Furthermore, Petitioner did not have a written policy for the protection of ventilator dependent residents in respiratory distress. It is evident that whatever non-written guidelines existed were either improperly communicated to the attending staff or were not diligently applied.

Resident number 126 (R126)

b. Petitioner failed to carry out the treating physician's orders and failed to properly document R126's medical charts. This had the potential for serious injury, harm, impairment, or death to the resident and constitutes immediate jeopardy.

State surveyor findings

On March 2, 1997, R126 was noted with an oxygen saturation level (SAO2)(4) of 80%, a temperature of 100.9, a pulse of 100, and respirations of 40. The treating physician was called, and treatment was prescribed for immediate administration. HCFA Ex. 1 at 22.

The doctor ordered a chest x-ray,(5) start IV and antibiotics, instill blue dye into the tube feeding,(6) and elevate the head of the bed 45 degrees. There is no indication in the medical chart that these orders were carried out, nor is there a complete assessment of R126 as per facility guidelines. HCFA Ex. 1 at 22 - 23.

Discussion

Petitioner argues that R126 was admitted to the facility in a vegetative state, and that it is reasonable to conclude that his death was attributable to his very precarious condition. Tr. at 760. Specifically, it asserts that when the charge nurse noticed changes in the resident's condition she proceeded to take proper action. She began to monitor the resident and called the treating physician, who prescribed a course of treatment over the phone. Petitioner alleges that all of the doctor's orders were complied with, even though they were not charted. Finally, Petitioner contends that the issue of whether the antibiotic, Timentin,(7) was administered is specious, inasmuch as Dr. John Hardek, the treating physician, testified that it takes 24 hours for that medication to take effect. Tr. at 761 - 762.

Contrary to Petitioner's assertions, Dr. Hardek testified that in his opinion the resident died of pneumonia (Tr. at 47) and that, with treatment, the resident may have recovered from the pulmonary condition. Tr. at 35. It is Dr. Hardek's testimony that it would take time for the antibiotic to start working. Tr. at 47. However, this fact, rather than justifying a failure to administer it, serves to underscore the need for its prompt administration so that its therapeutic effects could be felt as soon as possible.

For the reasons set forth below, I find that Petitioner was woefully inadequate in the treatment and care of R126, in violation of 42 C.F.R. § 483.25(k). Such conduct caused or was likely to cause serious injury, harm, impairment or death to the resident.

The treatment and care charts for R126 do not reflect that any of Dr. Hardek's orders, telephonically relayed on March 2, 1997, were carried out. P. Ex. 9. It is unknown how much time transpired from when Dr. Hardek gave his instructions over the phone to when the resident passed away. From the totality of the record, it is reasonable to conclude that several hours passed. There is an indication in the record that the treating physician gave his orders during the morning portion of the nurse's 7:00 a.m. to 3:00 p.m. shift. Tr. at 335, 337. The progress notes have a "12 noon" insertion as to when the resident was found dead, but that entry is unreliable. P. Ex. 9 at 5. That insertion appears to have been made after the fact at some unknown date and time by the charge nurse, Ms. Tamilyn Lawrence, whose testimony, as will be seen below, was vague and replete with generalities.

As charge nurse, it was Ms. Lawrence's duty to follow through with Dr. Hardek's orders. She testified that she carried these out in the following way:

I believe we would have gotten the Timentin started. Otherwise, I would have called the doctor.

Tr. at 342. She allegedly asked her Assistant Director of Nursing (ADON) to help her with the IV antibiotic, because:

I was busy doing other things. I had asked my ADON to at least -- to help me, and I guess we had discussed what would be better. She went to the emergency kit or she went to get the Timentin, and I was trying possibly to do other things, either go and call for the chest x-ray, and I think I sent an aide down to the kitchen to get blue dye for the tube feeding.

Tr. at 342 - 343.

Additionally, she "probably" asked the respiratory therapist to take samples for a sputum culture. Tr. at 364.(8)

Of all the orders given by Dr. Hardek, the only one Ms. Lawrence claimed that she did herself was the insertion of the blue dye in the feeding tube. Surprisingly, she could not say what the results were, nor did she make a record of it. Tr. at 343 - 344. She claimed that she was too busy to be able to provide for the needs of R126, but she made no specific mention of any particular task that took precedence over the care and treatment he required at that critical moment. Although Ms. Lawrence allegedly asked others for help, she could not say for certain whether the sputum samples were taken or whether the antibiotic was given.

If Ms. Lawrence had carried out all of the treating physician's orders herself, and had stayed by the resident's bedside monitoring him throughout his crisis, I might be more persuaded that there was an excuse for not documenting the medical charts. However, the only entry required of her was that of the administration of the blue dye test. The ADON, who allegedly administered the antibiotic, also failed to make an entry to that effect. Likewise, the respiratory therapist, who supposedly took the sputum sample, also failed to record the event. It would have been very easy for Petitioner to produce the results of the sputum tests and x-rays, the findings of the blue dye test, or an entry showing the dispensing of the antibiotic. Because it did not do any of these things, too many factors converge to detract from Petitioner's credibility regarding compliance with Dr. Hardek's orders.

Petitioner's argument that, even if it had fully complied with the treating physician's orders immediately the resident would still have died, is unavailing. A finding of immediate jeopardy does not hinge on a showing of a direct causal relationship between the facility's failure to carry out the treating physician's orders and the death of the resident. Petitioner cannot argue that it did not immediately carry out the treatment and care prescribed for R126 because it knew that he would soon die. It is true that Petitioner was aware that R126 was extremely fragile and vulnerable, but that knowledge should have served as a catalyst for prompt and urgent action. The record presents a picture of a lackadaisical staff, rather than a staff aggressively treating a pneumonia that was further aggravating the resident's already compromised health.

Even if the physician's orders had been carried out and not charted, that alone would have placed the resident at great risk, inasmuch as responsible and meaningful follow-up treatment would have been at peril, absent such vital information. Matters are much worse here, however, in that there is not a shred of credible evidence that R126 was administered the treatment prescribed by his physician. That treatment was intended to treat a pneumonia, and as stated earlier, his treating physician identified that condition as the cause of death. It is irrelevant, as Petitioner argues, that R126 would have expired in spite of treatment. Petitioner had a duty with respect to R126 to administer the necessary care and treatment that would further R126's well being. Far from satisfying this requirement, Petitioner's actions, or lack thereof, had the potential to cause serious injury, harm, impairment, or death to the resident.

I also note that although R126 had a dangerously low SAO2 level at 80%, there is no documentation that he was suctioned or received respiratory therapy to increase his oxygen level. Ms. Lawrence testified that she recalled that R126 was suctioned, but had no recollection that ambu-bagging occurred or whether the oxygen levels on the ventilator were increased. Treatment or monitoring would be reflected in the progress notes or respiratory flow sheets, she said. Yet, she admits that the records fail to show that efforts were directed at increasing R126's SAO2 level. Tr. at 382 - 386.

Resident number 127 (R127)

c. Petitioner failed to adhere to the guidelines it had developed in February 1997, and implemented at the beginning of March 1997 for ventilator dependent residents in respiratory distress by not monitoring or providing proper follow-up assessments to R127. This had the potential for serious injury, harm, impairment, or death to the resident and constitutes immediate jeopardy.

State surveyor findings

The State surveyors determined that on March 5, 1997, at 10:00 p.m., R127 was found pale, with mottled extremities, and an SAO2 of only 75%. There was no complete assessment of the resident, no vital signs were taken, no follow-up assessments every 15 minutes were done, and no physician was notified. HCFA Ex. 1 at 23.

On March 7, 1997, at an unknown time during the 7:00 a.m. to 3:00 p.m shift, R127 was found cyanotic, requiring emergency ambu-bagging for five minutes. Nursing charted four follow-up notes, but only assessed R127's color and SAO2 levels. No vital signs or complete assessment were noted in the resident's record, as required by the guidelines. HCFA Ex. 1 at 23.

Respiratory Care made a note on March 7, 1997, during the 7:00 a.m. to 3:00 p.m shift, that R127 had a total of three episodes in which the resident required emergency bagging for 10-15 minutes and experienced twitching and turning of her head back and forth.

Her SAO2 dropped to 82%. There is no indication that the treating physician was notified of the multiple episodes of respiratory distress. HCFA Ex. 1 at 23 - 24.

Again on March 10, 1997, there is a note by Respiratory Care, during the 7:00 a.m. to 3:00 p.m. shift, that R127 had another episode of turning blue, yet there is no nursing entry addressing respiratory distress and no vital signs or assessments were charted. HCFA Ex. 1 at 24.

On March 21, 1997, at an unknown time during the 7:00 a.m. - 3:00 p.m. shift, R127 was found with mottled legs, shaking, and SAO2 of 74%. The physician was there and she was ambu-bagged and given Valium. No complete assessments were done and follow-up was not carried out as per the guidelines. HCFA Ex. 1 at 24.

On March 25, 1997, R127 was found to have MRSA (methicillin-resistant staph aureus) in the sputum. R127 was found dead at approximately 7:45 p.m. on March 27, 1997. HCFA Ex. 1 at 24.

Discussion

Dr. Alberto Saltiel, R127's treating physician and Petitioner's medical director at the relevant time (Tr. at 62, 79), diagnosed R127 with pneumonia, and noted that she had been experiencing episodes of respiratory distress and convulsions. During the period preceding her death, he gave orders aimed at making the resident comfortable. This, he said, entailed raising the oxygen saturation level and stopping the seizures. Specifically, Dr. Saltiel stated that he directed that she be given respiratory therapy, Valium, and Dilantin. Nothing was prescribed for her pneumonia in view of her do not resuscitate (DNR) status.(9) Tr. at 65 - 73.

Doctor Saltiel testified that R127 was admitted to Petitioner after surgical removal of an esophageal diverticulum. Allegedly, she was also suffering from chronic obstructive pulmonary disease (COPD) which, in the treating physician's opinion, was terminal.(10) Doctor Saltiel further stated that the resident's family placed her in the nursing home for the purpose of receiving comfort care, and that nothing was to be done to prolong her life. In spite of that, it was Doctor Saltiel's opinion that R127 had lived beyond expectation.(11) Tr. at 64, 66.

Petitioner has presented no evidence to rebut HCFA's assertions that it failed to follow its own policy regarding the care and treatment of ventilator dependent residents in respiratory distress. In this respect, Dr. Saltiel's testimony not only confirmed the wisdom of the policy,(12) but also highlighted its ineffectual application. For example, on March 5, 1997, R127 was noted to have a pale color, mottled extremities, and an SAO2 of 75%.(13) The progress notes show that she was ambu-bagged for five minutes and her SAO2 increased to 97%. The attending nurse noted that monitoring would continue. The record does not indicate how the monitoring would be done, nor is there documentation evidencing that monitoring was performed. P. Ex. 11 at 2.

Dr. Saltiel conceded that a resident who has experienced respiratory distress should be stabilized and monitored to ensure that return to normal functioning has in fact occurred. He also agreed that the guidelines for care and treatment of respiratory distress residents adopted by Petitioner called for monitoring every 15 minutes for a total of one hour. Tr. at 114 - 115. Such monitoring, as per the policy, encompasses vital signs, respiratory status, oxygen saturation level, lung sounds, ventilator settings, level of consciousness, odor, color, and consistency of secretions, and comfort level of the resident. P. Ex. 10. Such charting is absent from the progress notes of R127 during the various respiratory distress events mentioned by the surveyors in the findings noted above.

Although Dr. Saltiel appeared to recognize the virtues of the respiratory distress guidelines, he seemed confused regarding its application. Pertinent to this is his distorted understanding of the requirement to monitor a resident at 15-minute intervals for up to an hour after a respiratory distress event. When asked by counsel for HCFA whether or not the facility should have monitored R127 every 15 minutes on March 5, 1997, Dr. Saltiel responded that the resident was monitored more often than every 15 minutes. He added that just because the guidelines say that monitoring should be done every 15 minutes, it does not mean that it can't be done more often. In support of this statement, he referred to the entry at page 2 of P. Ex. 11, where it says that the resident was ambu-bagged for five minutes when she was found with an SAO2 of 75%. Tr. at 115 - 116. Clearly, the intent of the guidelines is that, after being properly stabilized, a resident should then be monitored every 15 minutes for up to an hour. The number of minutes during which the resident is initially oxygenated bears no connection to the 15-minute interval monitoring after stabilization. The logic behind the conclusion that ambu-bagging for five minutes constitutes monitoring at less than the 15 minute interval called for in the policy escapes me.

Elsewhere, Dr. Saltiel testified that multiple crises of respiratory distress do not warrant notification of the treating physician as per the guidelines. On a personal level, he thought it would be a matter that he would like to be informed about. Tr. at 119. In saying this, he overlooked the language of the Nursing Guidelines for Ventilator Dependent Residents in Respiratory Distress. The last paragraph of page 1 of that document states as follows:

Any further respiratory distress will warrant an immediate call to the attending physician and continued observation and documentation throughout the shift, or until the resident stabilizes or is transferred to a hospital.

P. Ex. 10 at 1.

Dr. Saltiel, as well as Ms. Carolyn Nealy, the respiratory therapist, acknowledged that R127 experienced multiple episodes of respiratory distress on March 7, 1997. Tr. at 117, 455 - 456. Notwithstanding the unequivocal requirement of the guidelines, Dr. Saltiel seemed unfazed by the fact that R127, his patient, had experienced a series of respiratory distress events on March 7, 1997, and he was not notified. P. Ex. 11 at 3.

It is not clear whether R127 experienced respiratory distress on March 10, but she did have such an event on March 21, 1997. P. Ex. 11 at 3 - 4. As with respect to the earlier dates of March 5 and 7, no proper charting or monitoring, as required by the guidelines for respiratory distress residents, was performed. It is noteworthy that the progress notes show that on March 21, when R127 went into respiratory distress with an SAO2 of 74%, she was ambu-bagged by the therapist. P. Ex. 11 at 4. However, the therapist, Ms. Carolyn Nealy, testified that when she began to ambu-bag R127, Dr. Saltiel ordered her to stop because the resident was twitching and Dr. Saltiel said that the ambu-bagging would not relieve the twitching. Tr. at 462. That reasoning leaves me aghast since the therapist was not providing relief for the twitching, but for the respiratory distress. The incident is particularly disturbing in light of Dr. Saltiel's testimony that the respiratory distress caused oxygen decrease in the brain, and that, in turn, produced the convulsive reaction. Tr. at 68. It would appear logical, then, that the convulsions or twitching could be relieved by restoring oxygen to the brain through ambu-bagging. At one point in his testimony, Dr. Saltiel stated that on March 21, 1997, R127 was treated according to the guidelines by improving her oxygen level. That, he said, would provide comfort for the resident. Tr. at 73. Ms. Nealy's testimony, which I believe to be true, establishes that what Dr. Saltiel did was make R127 suffer from lack of oxygen. I find Dr. Saltiel's testimony at pages 68 and 69 of the transcript, to the effect that his orders were directed at stopping the seizures with Valium and Dilantin, consistent with Ms. Nealy's testimony that the physician did not allow her to provide emergency oxygen to the resident.

If the medical director had a flawed understanding of the application of the guidelines for handling respiratory distress residents, I am not surprised that the nurses and respiratory therapists displayed the kind of ignorance as to those same matters that permeate the record of this case.

I find the testimony of Ms. Joella Daniel, a surveyor, persuasive that Petitioner failed to monitor R127 during and after episodes of respiratory distress. This is particularly true on March 5, 7, and 21, 1997. From Ms. Daniels' testimony, I conclude that monitoring after ambu-bagging at successive intervals is crucial because an elevated SAO2 level immediately after oxygenation does not tell the true story of oxygen levels in the blood. The pulse, respiration, blood pressure, and temperature readings are some of the indicators of true stabilization. A resident's elevated SAO2 level immediately after ambu-bagging could be misleading. Thus, there is a need to continue close observation and scrutiny at successive intervals. Accurate recording in the progress notes of indicators such as those mentioned above will provide medical personnel vital information for the proper care and treatment of a respiratory distressed resident. On the other hand, the absence of such monitoring and charting of critical data regarding a respiratory distressed resident places that individual at risk for serious harm or death. Tr. at 171 - 175.

Also damaging to a resident could be the failure to notify the treating physician of such abnormalities as repeated episodes of respiratory distress. That is precisely what occurred on March 7, 1997. Petitioner's own policy states that more than one episode of respiratory distress warrants an "immediate call" to the treating physician. P. Ex. 10. In view of this, I do not give credence to Dr. Saltiel's testimony that repeated episodes of respiratory distress are not unusual, and therefore, impliedly of no serious concern. Tr. at 118 - 119. Ms. Daniels, on the contrary, considered that three episodes in one shift was significant and should have triggered notification of the treating physician. Tr. at 182 - 183. Likewise, Ms. Tamilyn Lawrence, one of Petitioner's nurses who had worked at Petitioner's facility since 1989, was of the opinion that three episodes in one shift requiring emergency respiratory care is not a common occurrence. She went on to agree that such a serious situation mandated adherence to the facility's respiratory distress protocol. Tr. at 392.

On cross-examination of Ms. Daniels, counsel for Petitioner tried to highlight that the record reflected that on those occasions in March 1997 when R127 went into respiratory distress, the treatment given brought about improvement in her condition. Tr. at 244 - 247. However, those references in the record indicating a positive response to treatment are not evidence that Petitioner carried out the assessments and monitoring at 15-minute intervals required by the guidelines. By failing to address the issue squarely, and pointing to irrelevant matters, Petitioner implicitly concedes that it ignored the application of its own policy. As stated earlier, its witnesses extolled the virtues of the policy, but few, if any, would live by it. Lip service falls far too short of the requirements.

I find that Petitioner's failure to properly assess and monitor R127 during and after episodes of respiratory distress, as well as the failure to notify the treating physician regarding repeated episodes of respiratory distress, exposed the resident to risk of serious injury, harm, impairment, or death.

Residents 83 and 68 (R83 & R68))

d. Petitioner failed to adhere to the guidelines it had adopted in March 1997 for ventilator dependent residents in respiratory distress by not monitoring or providing proper follow-up assessments to R83 & R68. This had the potential for serious injury, harm, impairment, or death to the resident and constitutes immediate jeopardy.

State surveyor findings (R83)

On March 23, 1997, at 8:30 a.m., R83 was found non-responsive. SAO2 was only 75% and vital signs were as follows: blood pressure 60/- (systolic only shown); pulse 100; respirations 12; and temperature 98.6. R83 was ambu-bagged and suctioned, with a large amount of thick, green-yellow sputum received, and the treating physician was called. The next entry was at 9:30 a.m., an hour later, noting that R83 was responding. This entry noted blood pressure, pulse, SAO2 level, and that an IV was started. The next and final follow-up entry was not made until 12:00 p.m., and it only noted blood pressure, pulse, and SAO2 level. HCFA Ex. 1 at 25 - 26.

Discussion

Ms. Daniels testified that on March 23, 1997, at 8:30 a.m., R83 was non-responsive to any verbal stimuli. The blood pressure reading only registered a systolic of 60, and the diastolic was so low that it was unobtainable. That would be indicative, she said, of a semi-shock state, where oxygen may not profuse throughout the body. She added that the pulse rate was 100 and the respirations were 12. The increased heart rate was the body's response to the lack of oxygen. She explained that, by pumping harder and faster, the heart tries to bring oxygen to the tissues. Tr. at 193 - 196.

The progress notes show that R83 had an SAO2 of 75%. From earlier references, it is known that this level of oxygen placed the resident at great risk. He was ambu-bagged and suctioned. The suctioning was productive of a large amount of green-yellow sputum. HCFA Ex. 16 at 2. The treating physician was called and orders were received. However, the charge nurse failed to specify what those orders were.

The clinical picture presented by R83 is obviously that of a resident in respiratory distress. The situation should have triggered the application of the guidelines for respiratory distressed residents. Those guidelines had been adopted in early March 1997, and it is evident that, on March 23, the charge nurse continued to ignore its application. After R83 was ambu-bagged and suctioned at 8:30 a.m., no further clinical observations were recorded until 9:30 a.m. There was no monitoring at 15-minute intervals, as required by the guidelines for ventilator dependent residents in respiratory distress.

Again, Petitioner does not address its failure to apply the guidelines for ventilator dependent residents in respiratory distress. Those guidelines were intended to secure the best possible treatment for residents such as R83. Although his condition was extremely critical, and every minute counted, he remained unattended for an hour. It was not until 9:30 a.m. that he was treated with an IV. At that time his SAO2 had increased to normal or near normal range, and his blood pressure increased to 110/60. HCFA Ex. 16 at 2. The fact that he showed improvement does not excuse Petitioner's failure to follow the guidelines.

That R83 survived Petitioner's incompetent care and treatment does not excuse the fact that he was placed at risk of serious injury, harm, impairment, or death.

State surveyor findings (R68)

On April 3, 1997 at 8:15 p.m., R68 became cyanotic with an SAO2 of 75%, requiring emergency ambu-bagging and increasing the FIO2 (fraction of inspired oxygen) on the ventilator to 40%. Nursing failed to make complete assessments and vital signs as indicated in the new guidelines. On April 4, 1997, Respiratory Care made a note that R68 was too unstable to perform routine tracheostomy change. HCFA Ex. 1 at 25.

Discussion

Petitioner's ventilator flow sheet for R68 reflects that on April 3, 1997, at 7:15 p.m., the resident was cyanotic and had an SAO2 of 71%. P. Ex. 12 at 8. The therapist ambu-bagged R68 with oxygen, but there is no indication that R68 was monitored thereafter in accordance with Petitioner's respiratory guidelines. Tr. at 229. Petitioner's records do not indicate whether R68's SAO2 level returned to normal after ambu-bagging or whether R68 was stabilized. The next record reference to R68 was not made until 8:15 p.m., an hour later. At that time, a nurse noted that R68 was again cyanotic with an SAO2 of 75%. Ambu-bagging was again performed. P. Ex. 12 at 3. While R68 was monitored at 15-minute intervals beginning at 8:15 p.m., the assessments omitted some vital sign information and other required evaluation data.

The record shows that, notwithstanding R68's extreme fragility, he did not have the benefit of care and treatment required for ventilator dependent residents in respiratory distress. Ms. Daniels testified that it was "pretty lucky" that nothing serious happened to R68, because, in a matter of minutes, brain damage could be sustained from lack of oxygen. Tr. at 230. Petitioner's duty to provide appropriate respiratory care to its ventilator dependent residents cannot be a matter of chance. It has to assure a resident 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. 42 C.F.R. § 483.25.

I note, however, that the inability to perform routine tracheostomy care on R68 on April 4, 1997, is not indicative of a deficiency on the part of Petitioner.

Residents 6 and 11 (R6 & R11)

e. Petitioner failed to ensure that R6 and R11 received proper tracheostomy care. This had the potential for serious injury, harm, impairment, or death to the residents and constitutes immediate jeopardy.

State surveyor findings

On April 2, 1997, the surveyor observed an employee at Petitioner's facility perform tracheostomy care on R6 And R11 without using sterile procedures and without hyper-oxygenating(14) the residents prior to or after suctioning. HCFA Ex. 1 at 26 - 27.

Discussion

HCFA contends that the failure to apply sterile suctioning procedures runs counter to Petitioner's own policy. HCFA Ex. 21; Tr. at 734. Specifically, Ms. Benton-Babatunde, a surveyor, testified that the employee providing tracheostomy care to R6 and R11 used an improper solution to clean the trachea prior to initiating suctioning procedure. The employee used the same solution to clear the catheter after suctioning as well as during the process. By using the same solution to clear the suctioning tubing as well as to clean the area around the tracheostomy site, the affected resident is put at great risk of having bacteria introduced into the trachea and lungs. The result, stated Ms. Babatunde, could be pneumonia or sepsis, where the bacteria traveling through the circulatory system causes generalized body infection. Tr. at 297 - 298.

Proper hygiene is especially critical in the case of nursing home residents, due to their high level of susceptibility to pneumonia and other infections. More significantly, they are more vulnerable to the more virulent types of pneumonia. Tr. at 55, 298.

The surveyor's findings also indicated that the employee providing tracheostomy care to R6 and R11 failed to hyper-oxygenate the residents prior to or after suctioning. Petitioner addressed this with the testimony of Ms. Joyce Casares, a nurse. She testified that hyper-oxygenation of the resident is not necessary because the facility has a "closed system" of respiratory therapy. With that system it is not required to remove the resident from the ventilator during suctioning. Tr. at 415 - 416. At a later point in her testimony, however, she conceded that during suctioning no air would be able to enter the lungs. In that case, even in the presence of a "closed system," the oxygen deprivation would appear to justify hyper-oxygenation. Tr. at 428 - 429. This testimony was contradicted by another of Petitioner's witnesses, Ms. Benda. Ms. Benda indicated that in a "closed system" the ventilator dependent resident is not deprived of oxygen at any time during suctioning. Tr. at 497 - 498.

In addition to the above, there is another inconsistency noted between the testimonies of Ms. Benda and Ms. Casares. Whereas Ms. Casares (who worked at Petitioner's facility for 27 years), stated that the so called "closed vent system" had been in place at the facility since "almost the very beginning" (Tr. at 415), Ms. Benda stated that at the time of the incidents leading up to this case, the "closed system" was fairly new to the field of respiratory therapy. Tr. at 496.

In rebuttal, HCFA recalled Ms. Benton-Babatunde to the stand. She stated that during the survey of the facility, Petitioner presented her with a policy titled "Sterile Suctioning of a Tracheostomy Tube." HCFA Ex. 21; Tr. at 734. That policy addressed the kind of suctioning procedure performed with the equipment observed by Ms. Benton-Babatunde on April 2, 1997. That policy did not refer at all to the "closed system" suctioning method mentioned by Ms. Casares and Ms. Benda. More importantly, the guidelines made available to the surveyor went to great lengths to explain the proper way to perform sterile suctioning and how to properly hyper-oxygenate a resident.

If, as Ms. Benda testified, the closed system was new, it could not have been in place since "almost the very beginning," as alleged by Ms. Casares. On the other hand, if it was new, it was not yet in use at the time of the survey in question. At best, it could have been in the process of being phased in, but on the day of the survey, Ms. Benton-Babatunde did not see that "new" system. She only saw the method that requires hyper-oxygenation, and Petitioner gave her the policy that applied to that type of suctioning procedure. Moreover, Mr. Jesus Rodriguez, the director of respiratory care, testified that staff would hyper-oxygenate a resident if it were deemed to be needed. It was a clinical judgment, he said. Tr. at 556. He appeared to recognize the existence of a suctioning method that could call for hyper-oxygenation, even though his testimony was a departure from the suctioning protocol adopted by the facility that mandated hyper-oxygenation. This evinces Petitioner's poor dissemination of its policies to the staff. It is particularly disconcerting that those in supervisory positions were so ill-informed.

In view of the foregoing, I find Ms. Benda's and Ms. Casares' testimony regarding the suctioning method employed at Petitioner on April 2, 1997, not credible. Ms. Benton-Babatunde's testimony is more consistent with the evidence of record and deserving of probative value. In reaching this conclusion, I must also say that Petitioner presented no reliable evidence to discredit the surveyor's testimony that in the tracheostomy care of R6 and R11, it failed to apply proper sterile suctioning technique and it did not ventilate the residents with enriched oxygen, as required by its own policy guidelines. HCFA Ex. 21.

The deficient tracheostomy care provided to R6 and R11 placed them at risk of serious injury, harm, impairment, or death.

Resident Number 130 (R130)

f. The conduct of Petitioner with respect to R130 does not constitute a deficiency.

State surveyor findings

On March 17, 1997, at 1:00 a.m., R130 complained of a swollen neck and difficulty breathing. The respiratory therapist attempted suctioning, but the results were unproductive. Respiratory treatment was then given, along with Ativan, as needed. No complete assessment was done, nor were vital signs taken. HCFA Ex. 1 at 25.

Discussion

I note from the record that R130 had an SAO2 of 96% at 1:00 a.m. on March 17, 1997, and was not in respiratory distress. P. Ex. 14 at 5; Tr. at 75, 412. Thus, no lack of compliance may be attributed to Petitioner regarding the treatment and care of a respiratory distressed resident arising from its handling of R130.

2. Beginning December 20, 1996 and continuing through April 3, 1997, Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25 at the immediate jeopardy level.

During the period beginning December 20, 1996 and ending April 3, 1997, Petitioner failed to comply with the regulatory requirements of 42 C.F.R. § 483.25 by exposing its residents to risk of serious injury, harm, impairment, or death. This regulation provides that a long-term care facility must ensure that residents receive proper treatment and care for special services, including tracheostomy care, tracheal suctioning, and respiratory care.

The evidence in this case establishes that Petitioner failed to provide its residents with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being. HCFA proved that on December 20, 1996, Petitioner did not have a written policy to protect its ventilator dependent residents who went into respiratory distress. Moreover, notwithstanding the absence of written guidelines, Petitioner's supervisory staff expressed awareness of the proper procedures for tracheostomy and respiratory care, but did not communicate these to the nursing staff or to respiratory therapists. Tr. at 397, 484, 522, 523, 556 - 558.

Petitioner claims that the incident that resulted in the death of R10 was an isolated accident. Tr. at 324. That, Petitioner reasons, diminishes its level of culpability. I disagree. As stated earlier, the respiratory therapist attending to R10 did not accidentally turn off her breathing machine. He deliberately turned it off so as not to be inconvenienced by the sound of the machine's alarm while another therapist was in the process of manually elevating the resident's SAO2 level. True, he may have accidentally left the machine turned off, but such oversight is not to be taken lightly or ignored. It resulted in the death of a human being. That is not to say that Mr. Anderson's conduct was criminal in nature, as Petitioner also claims. P. Response at 17. There is no evidence in the record that he was held criminally liable for the death of R10. He was, however, clearly negligent in turning the respirator off so as not to be bothered by the alarm. By turning it off, he placed himself at risk of forgetting to turn it back on after manually elevating the resident's oxygen level. Mr. Anderson's action is more connected with Petitioner's failure to have clear and written guidelines that were effectively communicated to its employees than with criminal intent.

Petitioner argues also that I should give weight to a visit made by IDPH surveyor Margaret White shortly after R10's death. Petitioner argues that Ms. White's failure to find an immediate jeopardy at that time creates an inference that no immediate jeopardy existed.

The record shows that Ms. White visited Petitioner on January 2, 1997. She was at Petitioner for about two hours and looked only into the facts concerning R10. Tr. at 621 - 622. Ms. White left that day without issuing a written statement of deficiencies. Instead, she indicated that she was still gathering facts. She stated that she had to wait for the police report and she needed to consult with more people. Tr. at 622 - 623, 679. Moreover, at the time of Ms. White's visit, a more thorough annual survey was expected to be conducted. Tr. at 521. That survey was completed on April 8, 1997. By that time, all of the evidence concerning R10 was available. In view of the foregoing, I do not accept Petitioner's claim that Ms. White's failure to make findings in January 1997 invalidates the later finding of immediate jeopardy based on the more complete information gathered by April 8, 1997.

Furthermore, the evidence establishes that Petitioner failed to protect other residents from similar acts until April 4, 1997. It was not until April 4, 1997, that Petitioner had taken adequate steps to train its staff regarding the treatment and care of ventilator dependent residents. The record shows that by April 4, 1997, Petitioner had taken the following the actions:

1) A new protocol was initiated for assessment, care, and follow-up of ventilator dependent residents in respiratory distress.

2) Immediate one-to-one training regarding the newly developed guidelines for all respiratory care and nursing staff.

3) 24-hour management supervision of staff was initiated.

4) A new policy was initiated concerning the hiring of respiratory therapists, and their qualifications and training.

5) A new skills/procedural checklist for ventilator dependent residents was developed to assess each licensed and respiratory care staff member. Checklist assessment was initiated on April 4, 1997, for all working personnel, to be completed each shift. The assessment would continue until all staff was assessed.

See HCFA Ex. 1 at 31.

From December 20, 1996, until the above abatement actions were initiated, Petitioner took minor steps to comply with its duty to care for and protect ventilator dependent residents, but fell short to the point of continuing to place them at risk of serious injury, harm, impairment, or death. For example, I note that on December 23, 1996, three days after the incident involving R10, Petitioner conducted a 20 minute in-service concerning matters of notification of death in such cases. On January 8, 1997, Petitioner conducted another in-service regarding the operation of the respiratory ventilator. P. Ex. 8. These training sessions fell far too short of satisfying what was required to abate the immediate jeopardy.

Petitioner's additional claim that it took immediate corrective action on December 20, 1996, by hiring Mr. Jesus Rodriguez, a certified respiratory therapist, to consult with Petitioner about the care provided to ventilator dependent residents, is without merit. Basically, all that action accomplished was to replace the lost services of the former director of the respiratory care unit, who had left due to medical problems. Tr. at 676. Besides, Mr. Rodriguez's testimony accentuates the facility's failure to properly communicate its policies to the staff. As I stated earlier, the testimony of Mr. Rodriguez regarding sterile suctioning of a tracheostomy tube highlighted his ignorance in this important area of resident care. I specifically stated how disturbing it was that those in supervisory positions were so ill-informed. Thus, no corrective measures were, in reality, advanced by bringing in a new respiratory care director or consultant who carried on the facility's history of ignorance concerning respiratory care.

This ignorance is further evidenced by Petitioner's argument at page 19 of its brief. Its fragmented view of the requirements for proper care and treatment of residents in respiratory distress leads to the following faulty reasoning:

Although R10 was being given care by staff, she was found unresponsive within 15 minutes of the last time she was with staff. HCFA's claim that monitoring R10 every 15 minutes would have resulted in her still being alive does not stand up to the facts in this case. Despite being given care by a respiratory therapist as late as 1:00 a.m., R10 was unresponsive by 1:15 a.m.

P. Brief at 19.

This logic overlooks factors such as mentioned by Ms. Daniels, one of the surveyors, in her testimony. She stated that once you raise a resident's oxygen level, you cannot rest assured that stability has been achieved. It is essential to note indicators required by Petitioner's written policy, such as vital signs and lung sounds. Tr. at 171 - 175. If the staff had taken R10's respirations, pulse reading, blood pressure, lung sounds, and other required indicators, they would have surely noted she was not breathing. This reasoning also ignores the testimony of Ms. Benda, Petitioner's DON. She agreed that the policy adopted by Petitioner in early March 1997 for the care and treatment of ventilator dependent residents in respiratory distress, embodied good nursing practices, and that R10 should have been monitored after having been apparently stabilized. Tr. at 502. Those guidelines were developed to ensure that a ventilator dependent resident who experienced any form of respiratory distress would be "observed" by the nursing staff and respiratory therapy department and properly treated and "relieved of her/his respiratory distress and documented on." P. Ex. 10 at 1. The documentation includes indicators such as blood pressure, pulse, respiration, temperature, lung sounds, and breath sounds. These indicators would serve as verification that a resident in respiratory distress, whose oxygen level has been increased, has achieved true relief. Once that is accomplished, follow-up assessment and documentation is mandated every 15 minutes. P. Ex. 10. If this procedure had been followed with respect to R10, the tragedy that unfolded would have been prevented.

In Petitioner's attempts to immediately address the circumstances that gave rise to the tragedy of December 20, 1996, involving R10, other weighty factors, including the adoption of written guidelines for the treatment and care of ventilator dependent residents in respiratory distress, were not considered. In this regard, Ms. Daniels testified that, after R10's demise, the lack of the facility's immediacy in initiating a protocol to prevent any further problems placed other residents who had episodes of respiratory distress at severe risk for harm, if not death. This, in her estimation, constituted immediate jeopardy. Tr. at 232.

Petitioner began to take more serious steps to address its duty to properly treat and care for ventilator dependent residents in respiratory distress in early March 1997, when it adopted guidelines for treatment of such residents. Unfortunately, however, no training was conducted in earnest, and residents continued to be placed at risk of serious injury, harm, impairment, or death, even after those guidelines were adopted. This is evident from the previous discussion regarding the improper treatment and care given to R126, R127, R83 and R68. The treatment and care given to these residents was contrary to the policy adopted by Petitioner in early March 1997, for the treatment and care of ventilator dependent residents in respiratory distress. Thus, they continued to be placed at risk throughout the month of March and through April 3, 1997. As already stated, it was not until April 4, 1997, that Petitioner initiated a comprehensive plan to address and abate the immediate jeopardy.

In view of the foregoing, I conclude that there is a basis to impose a CMP against Petitioner in the immediate jeopardy range for the period which begins on December 20, 1996, and which runs through April 3, 1997. HCFA satisfied all of the prerequisites for imposing such a penalty. First, HCFA established a prima facie case, which Petitioner did not rebut, that as of December 20, 1996, Petitioner was not complying substantially with the participation requirement at 42 C.F.R. § 483.25. 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 this requirement. Second, Petitioner failed to show that HCFA's determination that Petitioner's noncompliance with this requirement was at the immediate jeopardy level was clearly erroneous. In fact, the preponderance of the evidence establishes that Petitioner's deficiency was at the immediate jeopardy level. Third, Petitioner did not prove by the preponderance of the evidence that it had eliminated the immediate jeopardy to its residents on any date prior to April 4, 1997.

3. The amount of the penalty imposed by HCFA is reasonable.

HCFA imposed a $3,050 per day CMP for the period beginning December 20, 1996 and ending April 3, 1997. There is no issue as to the reasonableness of the daily amount of the penalty inasmuch as $3,050 is the minimum that may be imposed by HCFA 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).

HCFA also imposed a $50 per day CMP for the period beginning April 4, 1997 and ending May 14, 1997. There is no issue in this case as to whether a CMP of $50 per day for the period from April 4, 1997 through May 14, 1997 is reasonable. Petitioner has not contested the presence at its facility of deficiencies at less than the immediate jeopardy level during that period. A CMP of $50 per day for deficiencies that posed a potential for more than minimal harm to residents, but not at the immediate jeopardy level, is the minimum for such deficiencies. 42 C.F.R. § 488.438(a)(ii).

Conclusion

I conclude that HCFA correctly determined that beginning December 20, 1996 through April 3, 1997, Petitioner was not complying with federal participation requirements in the Medicare program at the immediate jeopardy level, and the imposition of a CMP of $3,050 per day is reasonable. I also conclude that from April 4, 1997 through May 14, 1997, HCFA properly assessed a $50 per day CMP for deficiencies that posed a potential for more than minimal harm, but not at the immediate jeopardy level.

JUDGE
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Jose A. Anglada

Administrative Law Judge

 

FOOTNOTES
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1. This matter was originally assigned to Administrative Law Judge Stephen H. Ahlgren. At the parties' request, the case was stayed for an indefinite period so that they could pursue settlement negotiations. On August 11, 1999, after months of inactivity, Judge Ahlgren ordered Petitioner to show cause why this case should not be dismissed for abandonment. In its response, Petitioner stated that it had not abandoned its request for hearing and that it had made several attempts to arrange settlement negotiations. On September 8, 1999, the case was reassigned to me. In the absence of objection, I allowed the case to go forward to hearing.

2. Disconnecting the resident from the ventilator is necessary for the manual administration of oxygen, but as will be discussed later, it is not necessary or desirable to turn the ventilator off.

3. Mr. Anderson submitted his resignation shortly after this unfortunate incident, and before Petitioner took any action against him. Ms. Harris was terminated when it was discovered, several weeks later, that she had falsified her respiratory therapist certificate and credentials. Tr. at 607, 302 - 304.

4. According to the treating physician, an SAO2 ranging from 92% - 100% is considered normal, and an SAO2 of 80% is dangerously low. Tr. at 40.

5. The x-ray was aimed at determining if there were findings consistent with pneumonia, congestive heart failure, pneumothorax, or other abnormal lung conditions. Tr. at 32 - 33.

6. A dye called methylene blue is placed into tube feedings to determine whether food is entering the lungs. Tr. at 35.

7. Timentin is a broad spectrum antibiotic. Tr. at 33.

8. While the HCFA Form 2567 does not specifically mention the sputum culture, the medical chart shows that Dr. Hardek ordered a sputum culture and stain. P. Ex. 9 at 7. The stain allows for immediate detection of bacteria, and the culture is grown in a microbiology laboratory. Tr. at 33.

9. Dr. Saltiel lay great emphasis on R127's DNR status. I would hope that such status is not at the root of the improper care and treatment given to this resident.

10. I note, however, that COPD is not an admitting diagnosis for R127. P. Ex. 11 at 1.

11. Regarding R127's clinical picture, I rely mostly on Dr. Saltiel's testimony inasmuch as the medical charts contain minimal charting by Dr. Saltiel. P. Ex. 11 at 9; Tr. at 63.

12. Dr. Saltiel perceived that the policy for handling respiratory distress residents was good. To a certain extent, however, he deferred to the expertise of Dr. Sabbagh, whose knowledge as a specialist in pulmonary diseases he respected. Dr. Sabbagh was Petitioner's pulmonary specialist and he was instrumental in developing the policy for the care and treatment of respiratory distress residents. Tr. at 121, 491.

13. It should be remembered that Dr. Hardek testified that an SAO2 of 80% was dangerously low. Tr. at 40.

14. Hyper-oxygenation is a procedure whereby the ventilator dependent resident is manually given added oxygen prior to and after suctioning. This makes up for the oxygen deprivation during the suctioning process. Tr. at 294 - 295.

CASE | DECISION | JUDGE | FOOTNOTES