SUBJECT:

Ballard Healthcare,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) against Ballard Healthcare (Petitioner) for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and Medicaid. The CMP of $3,050 for one day of non compliance is based on a finding of immediate jeopardy.

I. Procedural Background

This case came before me pursuant to a request for hearing filed by Petitioner on January 3, 2003, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g); 498.40.

Directed Inservice Training (DIST), effective October 13, 2002;

Denial of payment for new admissions (DPNA), effective October 13, 2002;

A CMP of $3,050 per instance for failure of the facility to prevent neglect of one resident (F 224) and a CMP of $3050.00 pers instance for the failure of the facility to provide emergency medical care to one resident (F 309); and

Termination effective February 22, 2002.

CMS Exhibit 4.

In a letter to Petitioner dated November 4, 2002, CMS agreed with the recommendations of the IDPH, but imposed a CMP of $3,050 per day for one day of immediate jeopardy on August 28, 2002, and $100 per day beginning August 29, 2002, which would continue to accrue until the facility was in substantial compliance or the provider agreement was terminated. Termination would be effective March 16, 2003, if the facility did not return to substantial compliance by that date.

CMS also imposed the following remedy:

Loss of Nurse Aide Training and Competency Evaluation Programs (NATCEP) for two years from September 16, 2002.

At the prehearing conference held on June 17, 2004, Petitioner reported that it would not contest the $100 per day CMP that began on August 29, 2002 and ended October 3, 2002. CMS reported that the only remaining issue was the imposition of $3,050 CMP for one day of immediate jeopardy. In view of the discussion at the prehearing conference and the agreement of the parties, the only issue before me is the two F-Tags, F-224 and F-309, and the CMP of $3,050, imposed for one day of immediate jeopardy. See Order and Notice of hearing dated June 29, 2004.

At the hearing conducted August 9 through 12, 2004, CMS offered 21 exhibits identified as CMS Exs. 1-21. Petitioner offered 3 exhibits identified as P. Exs. 1-3. The parties' exhibits were admitted into evidence without any objection. Transcript (Tr.) at 11. Both parties called expert witnesses: Dr. Andrew Weisberg testified for CMS, and Dr. Joseph V. Messer testified for Petitioner. I found both of these doctors qualified to testify as experts as to the pertinent issues in this case. Surveyors JoAnn Serpico and Antonio Gaffud, and paramedic Lance Neuses testified on behalf of CMS. Certified Nurses

Assistant (CNA) Nanya Patel, supervisory nurse Teresita Balderas, attending physician Dr. Robert Wolf, CNA Mary Tyus, Chief of North Maine Fire Department Robert Batey, paramedic John David Hall II, and facility administrator Eli Pick, testified on behalf of Petitioner.

Subsequent to the hearing, the parties submitted simultaneous post-hearing briefs (CMS Br. and P. Br.), as well as response briefs (CMS Response and P. Response).

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, on August 28, 2002, Petitioner was not in substantial compliance at the immediate jeopardy level. I further find that CMS was authorized to impose a CMP against Petitioner in the amount of $3,050 for one day of noncompliance.

II. Applicable Law and Regulations

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

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

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long term care facility that is not complying substantially with federal participation requirements. Part 488 of 42 C.F.R. provides that facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. �� 488.10 - 488.28. The regulations contain special survey conditions for long term care facilities. 42 C.F.R. �� 488.300 - 488.335. Under Part 488, a state or CMS may impose a CMP against a long term care facility where a state survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance and runs until the date substantial compliance is achieved or the provider agreement is terminated.

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

a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R. � 488.301.

The regulations 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 CMP's, 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 CMP's, 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).

"Immediate jeopardy" is defined to mean:

a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. ⁽¹⁾

42 C.F.R. � 488.301.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered:

1. The facility's history of non-compliance, including repeated deficiencies;

2. The facility's financial condition;

3. The seriousness of the deficiencies as set forth at 42 C.F.R. � 488.404; and

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

The Act and regulations make a hearing available before an administrative law judge (ALJ) to a long term facility against which 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 (8^th Cir. 1991).

III. Issues

A. Whether Petitioner was complying substantially with federal participation requirements on the dates CMS determined to impose a CMP;

B. Whether CMS's determination of immediate jeopardy is clearly erroneous; and

C. Whether the amount of the penalty imposed by CMS is reasonable, if non-compliance is established.

IV. Findings and Discussion

The findings of fact (Findings) and conclusions of law noted below in bold and italics are followed by a discussion of each finding.

A. The facility failed to develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property as provided by 42 C.F.R. � 483.13(c) (Tag F224).

B. The facility failed to provide Resident 17 with 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 as set forth at 42 C.F.R. � 483.25 under Quality of care (Tag F309).

(Because the facts for deficiency Tags F224 and F309 are exactly the same I discuss these findings together.)

Resident 17 (R17) was a 92 year old male with multiple diagnoses that included, among others, Diabetes Mellitus, Dementia, and weakness. A nutritional assessment dated February 19, 2002, revealed that he required assistance with feeding. CMS Ex. 9, at 1, 6. This was also reflected on the Minimum Data Set (MDS) eating assessment performed on February 28, 2002, which identified R17 as needing assistance by one person during meals. Id The care plan dated February 16, 2002, showed problems of impaired swallowing related to dysphasia and included the approach "supervise eating at all times."

Contrary to R17's comprehensive care plan, on April 13, 2002, he was left alone at lunchtime. After being left alone at lunchtime, facility staff observed R17 to be unresponsive, slouched forward, with food in his mouth. On that date, R17 expired while at Petitioner's facility. CMS contends that the likely cause of death was choking on food (a broccoli floret) which obstructed the resident's airway.

According to CMS, the way in which Petitioner's staff dealt with R17's condition when he was found to be unresponsive, demonstrates that the staff was incapable of responding competently to an emergency, and the residents were placed in immediate jeopardy. CMS bases its assertion of immediate jeopardy level noncompliance on the following specific allegations:

�Petitioner failed to provide R17 with supervision during meals due to impaired swallowing as required by the care plan;

�Petitioner wasted time before calling the paramedics to assist a resident who had been found unconscious;

� Petitioner's staff did not provide proper emergency resuscitation to a resident who was found unresponsive, had no pulse, and was not breathing, thereby endangering the life of the resident;

� Petitioner's staff displayed a lack of knowledge of the requisite techniques for performing cardiopulmonary resuscitation (CPR) and failed to perform CPR and the Heimlich maneuver appropriately in an emergency situation where correct use of those basic life support techniques might have saved the resident's life; and

� Petitioner failed to have readily available a barrier mask, Ambu Bag, or suctioning equipment, necessary for ventilation and clearing a resident's occluded airway, and Petitioner failed to suction the airway of a resident who had food in the airway, thereby endangering the resident's life. These allegations relate to the care that Petitioner's staff gave R17 on April 13, 2002, as set forth in the Statement of Deficiencies (SOD). CMS Ex. 3.

Petitioner argues that contrary to CMS's assertions, R17 did not need to be supervised at all times during meals and he did not suffer from dysphasia. Furthermore, maintains Petitioner, the facility nursing staff acted appropriately upon finding the resident unresponsive. P. Br. at 47, 48. Petitioner also presented the testimony of Dr. Robert John Wolf, the treating physician, who was of the view that the immediate cause of the resident's death was organic brain syndrome, and the underlying cause was diabetes, not choking on his food. CMS Ex. 18.

The evidence of record reflects that during an interview conducted on August 22, 2002, by surveyor Antonio Gaffud, CNA Mary Tyus, stated that on April 13, 2002, at approximately 11:50 a.m., she served R17 a lunch tray while he lay in bed in his room. Tr. at 97, 99. ⁽²⁾ After opening the resident's milk and juice, chopping his food into pieces, and encouraging him to eat, Ms Tyus left him alone and went to deliver lunch trays to other residents. Initially, she testified that she returned to R17's room in less than five minutes, (Tr. at 776), but on reflection, she pointed out that not even two minutes had elapsed from the time she left R17 eating his lunch until she returned to check up on him. Tr. at 793. Upon returning, she noticed that R17 was not eating his food. When she was unsuccessful in getting a response out of him she summoned her supervisor (Ms. Teresita Balderas) for help. Tr. at 775, 776.

Ms. Balderas, who was at a nearby nurses station testified that she ran to R17's room and saw the resident in a high Fowler's position. ⁽³⁾ Ms. Balderas stated that the resident gave the appearance of being asleep, his skin was warm and pale, he had no pulse, and he was not breathing. She noted that he was not cyanotic. Tr. at 614, 615, 615. Ms Balderas added that she sent Mary Tyus for the floor nurse while she continued with the assessment of the resident. She checked the carotid and wrist pulse and found none. Tr. at 616. She lowered the bed slightly and tried unsuccessfully to obtain a blood pressure reading. In Ms. Balderas' estimation, Ms. Tyus returned with the floor nurse (Ms. Hollie Adams), in less than 30 seconds. Tr. at 618.

Ms. Balderas further testified that when Ms. Tyus returned with Ms. Adams, she had Ms. Adams reassess the resident while she ran to ascertain the resident's status; that is, whether he was a full code or DNR (Do not Resuscitate). Tr. at 618. Ms. Balderas asserted that she immediately ascertained that R17 was a full code and called for a Code Blue in the resident's room and dialed 911. All told, according to Ms. Tyus and Ms. Balderas, from the time the resident was found unresponsive until the paramedics were called, not more than two or three minutes should have elapsed. This reasoning is based on Ms. Tyus' testimony that when she found R17 unresponsive and was unsuccessful in arousing him, she summoned Ms. Balderas, who responded to her call in less than a minute. Tr. at 777. When Ms. Balderas entered the resident's room she began to assess him, but before concluding her assessment, she instructed Ms. Tyus to get the floor nurse, and Ms. Tyus returned with Ms. Adams in less than 30 seconds. Tr. at 618. When Ms. Adams arrived, Ms. Balderas left her with instructions to further assess R17 and ran to ascertain the resident's DNR status (which she allegedly did immediately), and called 911.

CMS contends that Ms. Tyus found R17 to be unresponsive at 11:55 a.m. but advances no basis for that conclusion. My assessment of the evidence of record and CMS's argument in this regard, leads to me infer that CMS did not consider the time that Ms. Tyus spent positioning the resident, opening the juice and milk containers, ascertaining that his food was finely chopped, and encouraging him to eat. CMS developed its time-line based on the assumption that Ms. Tyus delivered the resident's tray at 11:50 a.m. and returned in approximately five minutes. This assumption, as stated above, does not take into account the set up time spent by Ms. Tyus with the resident prior to leaving the room in order to deliver other trays.

Based on Mr. Gaffud's testimony I find that Ms. Tyus served R17 his lunch tray at approximately 11:50 a.m. Tr. at 99. After positioning the resident, opening the juice and milk containers, and ensuring that the food was chopped finely enough, and encouraging him to eat, she went away from his room for no more than two minutes. Tr. at 793. During that time, she went out of the room to retrieve another tray, but before delivering it to the next resident, she was overcome with the notion to look in R17's room. It was at that moment that she noticed that the resident was not eating, and appeared to be sleeping. If all Ms. Tyus did was exit R17's room, retrieve a tray from the food cart in the corridor, and immediately return to the resident's room, she must not have been away more than a minute. Tr. at 775.

However, on the assumption that she was gone from R17's room for two minutes, she would have had to take no more than three minutes to set the resident up for his lunch meal, in order for CMS to be correct in its conclusion that R17 was found unresponsive at 11:55 a.m. If, instead, I were to assume that it took Ms. Tyus five minutes to set up the resident, as opposed to three minutes, I would have to find that the resident was found unresponsive by Ms. Tyus at 11:57 a.m.. In this regard, I find that five minutes would have been more than ample time for Ms. Tyus to roll R17's bed, open his juice and milk containers, make sure his food was finely chopped, and encourage him to eat. For the reasons that follow, however, I conclude that it does not matter whether Ms. Tyus set up the resident in three minutes, five minutes, or even ten minutes. In either case the paramedics would have been called more than ten minutes after the resident was found unresponsive.

The paramedic incident report reflects that the emergency call was received at the North Maine Fire Department at 12:13 p.m. CMS Ex.12, at 51. And the paramedics reached the resident's room between 12:17 and 12:18 p.m. Petitioner has been unable to account for the time that transpired from the time the resident was found unconscious until the paramedics were called. As fast as they were allegedly running around and immediately finding what they were looking for, it should have taken less than two minutes to call the paramedics. Of course, as I will discuss later, all of that running around was in vain. In fact, the paramedics should have been called immediately, with minimal passage of time. The only inference that I can draw is that the facility staff wasted precious time prior to placing the emergency call for help, as if they were dawdling. Thus, if I were to find that the resident was found to be unresponsive at 11:57 a.m., it took the facility staff approximately 16 minutes to call the paramedics. A close examination of the testimony of Ms. Tyus and Ms. Balderas and the statement of Hollie Adams sheds some light on why this occurred.

During her testimony at the August 2004 hearing Ms. Tyus gave the impression that when she was sent to get the charge nurse, she went directly to the east wing ⁽⁴⁾, and found her there passing medications in the dining room. Upon alerting Ms. Adams of the emergency, Ms. Adams immediately darted out in front of her and arrived at the resident's room first. Tr. at 777, 778. However, when interviewed by the surveyor on August 22, 2002, approximately five months after R17's fatal incident, her account of the events was somewhat different. Tr. at 97. At that time she reported that she delivered R17's tray around 11:50 a.m. Tr. at 99. After placing him in a high Fowler's position, cutting up his food, and opening his juice and milk containers, and encouraging him to eat, she left to deliver trays to other residents. She was away delivering trays for about five minutes and then returned to R17's room, whereupon she found him slightly laid back and slouched down. Tr. at 101. When Ms. Balderas instructed her to get the floor nurse, Ms. Tyus first looked around the 3 West unit, where the resident's room was located. Unable to find her there, she then looked in the opposite unit (3 East), and found her in the dining room passing medications. Tr. at 106, 107. She further told the surveyor that after giving the floor nurse (Ms. Hollie Adams) the message to accompany her to R17's room, she ran back. As she was half way back to the resident's room she noticed that Ms. Adams was not with her, so she returned and alerted Ms. Adams that the situation was an emergency. At that point, Ms. Adams followed her to the resident's room. Tr. at 108, 110. From Ms. Tyus' description of her actions during the search for Ms. Adams, I find that she could not have gone to get Ms. Adams and returned in less than 30 seconds.

In a statement provided by Ms. Hollie Adams regarding the incident giving rise to this litigation, she gave an account that is, in some respects, consistent with the information given by Ms. Tyus to surveyor Gaffud during the August 2002 survey. In her written summary of the incident, Ms. Adams stated that while attending to a resident that needed her services, a CNA [Ms. Tyus], who quickly passed by, told her, "you, come here; with no urgency or explanation." However, Ms. Adams continued with her tasks until the CNA returned a few minutes later and announced, "he's dead." CMS Ex. 13, at 103. The exclamation by Ms. Tyus could be an indication that she went all the way back to R17's room only to conclude that he had expired, or that it had been her concern since the moment she found him unresponsive, which may explain why there was no sense of urgency in the way she handled the resident's emergency.

Ms. Balderas testified that once Ms. Tyus returned with the floor nurse, she instructed Ms. Adams to continue to assess the resident until she went to verify his DNR status. After determining that the resident was full code, she double checked the Physician Order Sheet to find out if there was another order for DNR. Her next step was to call a Code Blue to alert the staff that there was an emergency, and then she called 911. Tr. at 620. In her description of the actions she took after learning that R17 was unresponsive, Ms. Balderas conveyed the impression that she was exceedingly expeditious in calling the paramedics. Tr. at 620. However, her explanation does nothing to account for the time elapsed from the moment R17 was found unresponsive until she finally called 911.

I find it reasonable here, to draw the inference that the facility did not have an immediate manner of establishing whether the resident had executed a DNR. Thus, it was necessary for the staff, in the case of R17, to go through his records to determine if he had a DNR order. Moreover, even after learning from his records that he did not have a DNR, Ms. Balderas had to search the Physician Order Sheet for further verification.

In the preceding analysis, I have explained that it took the facility more than 15 minutes from the time that R17 was found unresponsive until the paramedics were called. But the mishandling of R17's emergency does not stop there. What makes that time lapse more appalling is the absence of resuscitative care prior to the arrival of the paramedics.

An analysis of what transpired from the time R17 was found unresponsive until the paramedics arrived is very revealing. When Ms. Balderas was summoned to R17's room and she assessed the resident to be without pulse and respirations, she should have immediately instructed Ms. Tyus to call the paramedics and alert the staff to a Code Blue in the resident's room. After that, it was imperative for her to begin CPR protocol without delay. ⁽⁵⁾

Additionally, if a Code Blue had been called, other staff would have been promptly available to assist in bringing a crash cart and determining if the resident was DNR or full code. Tr. at 408. Instead of following this course of action, Ms. Balderas waited for Ms. Tyus to return with Ms. Adams so that she could be free to determine the resident's DNR or full code status and call the paramedics. ⁽⁶⁾ As I have stated earlier, Ms. Tyus did not know where Ms. Adams was, and initially searched in the West unit without success. When she finally found her in the East wing passing medications in the dining room, she did not convey a message of urgency to Ms. Adams, whose first reaction was to continue passing medications. Ms. Tyus headed back to R17's room, only to realize along the way that Ms. Adams was not following her. ⁽⁷⁾ During all of the time that Ms. Tyus was gone, Ms. Balderas did not perform CPR on the resident. The passage of time for seeking out Ms. Adams was definitely longer than the 30 seconds Ms. Balderas would have me believe. Clearly, several minutes elapsed. In fact. Ms. Adams stated that a few minutes elapsed from the time Ms. Tyus first summoned her until she returned for a second time. CMS Ex. 13, at 103. During that time she did not initiate CPR protocol as would have been appropriate, according to Dr. Andrew Weisberg and as established by the American Heart Association. Tr. at 395; CMS Ex.17. In fact, Ms. Ms. Balderas did not direct that CPR be initiated until after the charge nurse arrived and she had gone to ascertain whether the resident was a full code. It is evident that Ms. Balderas did not think that initiation of resuscitative measures was in order until the resident's DNR or full code status was determined. Tr. at 621. It is beyond question that the facility staff was very inept in the handling of R17's emergency. The staff appeared to be oblivious to the most elementary procedures for dealing with a crisis where a resident was found to be unresponsive. The actions taken by the facility staff constitute a significant departure from acceptable procedures. Tr. at 465.

The medically accepted Basic Life Support Guidelines as recommended by the American Heart Association for situations when a person is found unresponsive provides for the following sequence:

1. If you are alone, phone 911 or other emergency response system. If a second person is present, send that rescuer to phone 911 or activate the emergency response while you remain with the victim;

2. Open the airway and check for breathing;

3. If there is no effective breathing, attempt to provide 2 rescue breaths. If you are unable to make the chest rise, reposition the victim's head (reopen the airway) and try again to ventilate;

4. If ventilation is still unsuccessful (the chest does not rise) even after attempts to reopen the airway, straddle the victim's thighs and perform the Heimlich maneuver (or chest thrusts if the victim is obese or pregnant) up to 5 times;

5. After 5 abdominal thrusts, open the victim's airway using a tongue-jaw lift and perform a finger sweep to remove the object;

6. Repeat the sequence of attempts (and re-attempts) to ventilate, Hemilich maneuver, tongue jaw lift, and finger sweep until the obstruction is cleared or advanced procedures are available to establish a patent airway (e.g., Kelly clamps, Magill forceps, or cricothyrotomy); ⁽⁸⁾

7. If the obstruction is removed and the airway is cleared, check breathing. If the victim is not breathing, provide 2 rescue breaths. Then check for signs of circulation (pulse check and evidence of breathing, coughing or movement). If there are no signs of circulation, begin chest compressions.

Dr. Weisberg's testimony confirmed this CPR protocol. Tr. at 390-393. He added that once the airway has been cleared and is free of obstruction, it is necessary to alternate 2 rescue breaths and 15 chest compressions if a pulse is not present, as in the case of R17.

The evidence of record reflects that the above CPR protocol was not followed in the case of R17. Ms. Balderas, who was the senior and more experienced staff member present did not at any time provide resuscitative care to R17, although she was certified by the American Heart Association to provide Basic Life Support. Tr. at 642; CMS Ex. 12, at 96. Instead, she directed a CNA to get the charge nurse. However, by the time the charge nurse came to the resident's bed side, precious time had been lost. Dr. Weisberg stressed the importance of immediate intervention in the case of an unresponsive individual, because someone who is unresponsive only has minutes to get oxygen to the brain and to the cardiac system in order to maximize the potential for survival. Tr. at 398.

Ms. Adams' entry in the nurse's notes indicate that the first thing she did was assess the resident and then applied 2 chest compressions. She observed food in the back of his mouth and allegedly attempted resuscitative measures, without success. CMS Ex. 12, at 121. In a more detailed statement, Ms. Adams indicated that when she arrived at the resident's room, she assessed him and thought she felt a faint pulse. ⁽⁹⁾ CMS Ex. 13, at 103. She then placed herself to the left side of the resident and began chest compressions. Dr. Joseph V. Messer, Petitioner's expert witness testified that the facility staff provided appropriate emergency care to R17 based on a review of CMS Ex. 12, at 77a and 77b. According to Dr. Messer's expert opinion, those nurse's entries establish that the staff acted appropriately, because the nurse (Ms. Adams), outlined the sequence of events as she provided emergency care for R17 upon recognizing that he was in distress. The sequence narrated by Ms. Adams is simply that she entered the room and after assessing the situation, applied two chest compressions, noted food in the resident's mouth, and attempted resuscitation, without success. ⁽¹⁰⁾ In opining that this emergency care is appropriate, Dr. Messer overlooks the fact that the nurse failed to clear the airway, never ventilated the resident, and jumped to chest compressions, contrary to the American Heart Association guidelines as recited above. Surprisingly, Dr. Messer asserted that the nurse responded appropriately to R17's emergency, in spite of the fact that she did not clear the airway nor ventilate the resident prior to doing chest compressions. The above stated guidelines clearly indicate that one must ventilate the victim, and observe the chest rise before proceeding with chest compressions. If the chest does not rise when applying ventilation, the Heimlich maneuver should employed as part of Basic Life Support in order to remove any foreign body airway obstruction. Tr. at 615. In the undated statement provided by Ms. Adams she detailed the sequence of her actions by indicating that her very first step was to perform chest compressions. CMS Ex. 13, at 103. It is noteworthy that Dr. Messer stated that Ms. Adams correctly performed CPR on R17 although she admitted that she did not give the resident any rescue breaths. In fact, Dr. Messer was specific in his opinion that proper CPR procedures required a rhythmic approach of two "good breaths" followed by twelve compressions. Tr. at 1025-1026. It is clear that the record does not reflect that Ms. Adams followed that procedure. I am amazed at Petitioner's argument that its facility provided proper emergency care to R17, when it has been unable to explain why he was never provided with emergency ventilation from the time he was found unresponsive until the paramedics arrived.

Dr. Messer's opinion that the facility acted appropriately with respect to R17's crisis, was influenced by the emergency medical team's report (CMS Ex. 12, at 51) and the report of the emergency room department at Lutheran General Hospital. Tr. at 944. According to Dr. Messer the paramedic report is of significance because it provides times as to when the call was received, the time they were dispatched, when they responded, when they got to the hospital, etc. It lists important information about the medications that were administered and the time that they were administered while at the facility. I am puzzled as to how this paramedic report is helpful in demonstrating appropriate emergency care by the facility staff. If anything, this report shows that the facility was grossly negligent in the handling of R17's emergency. The report shows that the resident had an airway obstruction, and he had gone into cardiac arrest. The staff knew that R17, who had been care planned for impaired swallowing, was eating lunch alone prior to being found unresponsive, and staff even observed food in and around his mouth, yet they failed to properly clear the airway of any obstruction. In the comments section of the paramedic report it is stated that upon arrival at the nursing home, the paramedics noted that the resident had food in his mouth and the staff was not doing CPR. CMS Ex. 12, at 51. The time lines mentioned in that report are also damning to the facility in that it is shown that the paramedics were called at 12:13 p.m., that is, at least 15 minutes after the resident was found unresponsive. Ms. Adams stated in her undated declaration, made sometime after the incident, that when she was about to give mouth to mouth resuscitation to the resident, the CNA pulled her back and told her that he had MRSA( Methicillin-Resistant Staphylococcus Aureus). She initially hesitated, because she did not have the equipment, but decided to proceed with ventilation of the resident anyway. She went no further because at that point the paramedics arrived. It is quite telling that at no time prior to the paramedics' arrival, no one had given the resident a breath of ventilation. What Ms. Adams proposed to do was too little too late. ⁽¹¹⁾ The credible evidence of record demonstrates that when the paramedics entered R17's room no one was rendering care to the resident. Tr. at 871. If I were to accept as true Ms. Adams' statement that she was ready to provide mouth to mouth to the resident but hesitated when informed that he had MRSA, I would also have to find that Ms. Balderas was not accurate in her testimony to the effect that she brought a crash cart to R17's room to be used in providing him with emergency care. This is contradicted by Ms. Adams' statement that she did not have the equipment to give the resident mouth to mouth because he had MRSA. Indeed, Ms. Adams had reported to the surveyor that upon realizing that she did not have a barrier airway in order to administer rescue breaths to R17, she left the resident alone and went out of the room to get that equipment. Tr. at 334, 335.

According to Dr. Weisberg nursing homes are required to have some form of barrier system that could be a mask or Ambu Bag that allows nurses and other medical personnel to administer breathing without risk of infecting themselves. Tr. at 399, 400. That equipment would be typically found in a crash cart. Royal Manor, DAB CR1185 (2004). Finally, contrary to Ms. Baldera's testimony, the paramedics found the resident to be cyanotic. ⁽¹²⁾ Tr. at 615. This reference at CMS Ex. 12, at 51 was placed in the report that was prepared contemporaneous with the incident, whereas Ms. Balderas did not create a record of the incident at the time of R17's emergency.

Dr. Messer did not say how the record from the emergency room department at Lutheran General Hospital assisted him in forming an opinion as to why he concluded that the facility acted appropriately with respect to R17. Dr. Messer mentioned other portions of the record that led him to conclude that the facility provided appropriate emergency to R17, but his unpersuasive reasoning is not worthy of further discussion. Tr. at 945, 946.

Petitioner, in support of its argument, also presented the testimony of Dr. Robert John Wolf, the treating physician, who was of the view that the immediate cause of the resident's death was organic brain syndrome, and the underlying cause was diabetes. CMS Ex. 18. As can be easily gleaned from the Medical Certificate of Death, in the State of Illinois, the cause of death certification has two sections. Part I is for entering the condition or injury that caused the death. Part II is for identifying conditions or injuries that contributed to death but did not cause death. Part I has three lines for entry of the condition or injury causing death. The first line calls for the immediate cause of death. Dr. Wolf listed that condition as organic brain syndrome. The second line is the intermediate cause of death, and Dr. Wolf listed that cause to be cerebrovascular disease. The third line, calls for the underlying cause. ⁽¹³⁾ Surprisingly, Dr. Wolf listed diabetes as the underlying cause of R17's death. The evidence of record reflects that diabetes is not even remotely linked to the resident's death. ⁽¹⁴⁾ Additionally, no credible evidence has been advanced showing that he suffered a myocardial infarct on April 13, 2002, while eating lunch. ⁽¹⁵⁾ Tr. at 412. The Resident Care Plan prepared for R17, however, does show that the facility determined that R17 had impaired swallowing (dysphagia) and required supervision at all meals. He was to be particularly monitored and observed for choking or swallowing problems. CMS Ex. 12, at 32. A speech therapy evaluation performed on February 18, 2002, reflects a finding of mild oral dysphagia and "suspect" mild pharyngeal dysphagia. CMS Ex. 13, at 172. Given the medical evidence and the facts of this case, Dr. Weisberg was of the opinion that in all medical likelihood, R17 went into cardiac arrest from choking on his food. Tr. at 411, 412.

R17's medical charts do not document that he was going through an acute stage of illness or a worsening of his pre-existing conditions. In fact, from the time of admission until he was examined on April 11, 2002, by Dr. Wolf, R17 exhibited improvement in his overall status. Tr. at 687. The one ongoing concern at that time was the resident's impaired swallowing, a problem which Dr. Wolf did not appear to take seriously.

Thus, on April 13, 2002, when R17, who was care planned for impaired swallowing, was found unresponsive after being left alone to eat his lunch, and he was noted to be without respirations or pulse, with food in and around his mouth, the facility staff should have suspected that the resident may have choked on his food. Tr. at 401. Consistent with this, Ms. Tyus testified that she alerted the paramedics to the fact that the resident had been eating, and that's when they removed food from his "jaw." ⁽¹⁶⁾ Tr. at 788. This an indication that the facility staff had not cleared the resident's airway. However, the staff need not have suspected a choking incident in order to provide basic life support to R17.

In his testimony at the hearing, Dr. Wolf "assumed" that R17's ability to swallow had improved to some extent, (Tr. at 687), and did not think that he had dysphagia. However, he had only taken over the care of the resident two days prior to his demise, and he conducted no evaluation to assess the resident for swallowing problems. His testimony to the effect that he examined the patient, spoke to nursing staff, reviewed prior records in order to assess for swallowing difficulties lacks probative value, inasmuch as that analysis is not reflected in his assessment of R17. If he had truly reviewed the prior record, he would have noted that a speech evaluation done on February 18, 2002, revealed a diagnosis of dysphagia and that the care plan incorporated that diagnosis and placed the resident on swallowing precautions. I find that Dr. Wolf either glossed over those records or totally ignored them because he assigns little value to the resident's care plan. Tr. at 716.

Dr. Kristin Lelvis made an initial physiatric evaluation on March 25, 2002, and she stated that there were no swallowing difficulties. She did not however, reference the speech evaluation of February 18, 2002, that found the existence of swallowing difficulties, nor did she state whether she examined subsequent studies that pointed to a clinical improvement in the resident's status concerning his ability to swallow. If such studies do exist, they were not made available for my review during these proceedings. Moreover, the facility did not take that opinion seriously, inasmuch as no change was made to the care plan that required supervision of the resident during meals due to impaired swallowing. CMS. Ex. 13, at 47.

Ms. Angie Sherwood, the person who conducted the swallowing evaluation concluded that R17 had mild dysphasia. Based on those findings, the care plan was properly annotated to require supervision at meals and to observe swallowing precautions. CMS Ex.12, at 32, 13, 172. In a statement made after the August survey, Ms. Sherwood attempted to reconstruct her February 18, 2002 findings by clarifying that the resident was to have supervision as needed and that nursing was to be contacted should any swallowing difficulties be observed. CMS Ex. 13, at 267. If that statement is true, it is also true that the facility concluded that supervision of the resident due to swallowing precautions was needed at all meals. The facility also noted in the care plan that nursing should be informed of any choking or swallowing problems. CMS Ex. 12, at 32. Those care plan requirements were never modified. The care plan means what it says, and Ms. Sherwood cannot deny on the one hand what she affirms on the other, nor can her belated clarification have a retroactive overriding effect on that care plan.

Much documentary evidence and oral testimony went into the record regarding the issue of the resident's swallowing impairment and the need for supervision during meals. However, whether R17 required constant supervision while eating or suffered from dysphasia is irrelevant to the issue of whether the facility failed to provide basic life support care to R17. The crucial question that Petitioner has to address is what did its staff do for R17 when he was found unresponsive. There was also evidence presented with respect to the cause of death. That too is an issue that is not dispositive of the facility's culpability in this case. If the facility failed to provide basic life support care to R17 it does not matter whether the resident died from choking on food or experienced a myocardial infarct. Furthermore, CMS does not have to show that the resident's life would have been spared if resuscitative measures had been diligently administered.

Notwithstanding the foregoing, the evidence of record demonstrates that the facility failed to provide supervision during meals to a resident determined to have a swallowing impairment and also failed to provide that resident with resuscitative care when he was found unresponsive.

In view of the foregoing discussion I find that the prima facie evidence establishes the following:

�Petitioner did not have a clearly established policy and procedure to facilitate prompt treatment to residents in cardiac or respiratory emergency until August 29, 2002. CMS Ex. 12, at 123-129;

�Petitioner failed to provide R17 with supervision during meals due to impaired swallowing as required by the care plan. CMS Ex. 12, at 32.;

�Petitioner incurred in gross failure to provide necessary emergency resuscitation services to R17. The supervisory nurse wasted precious time waiting for a CNA to find and return with the charge nurse and also lost time determining whether the resident was a DNR resident or was a full code resident prior to directing the initiation of CPR protocol. Tr. at 621;

�The staff made a haphazard and incompetent attempt to resuscitate R17. Professionally recognized standards of nursing care require staff to clear a resident's airway before attempting to perform CPR and to keep the airway clear while CPR is underway. CMS Ex. 17. There was an obvious obstruction in R17's airway: a broccoli floret. Tr. at 541. The unrefuted evidence is that staff did not suction the resident or otherwise clear his airway. Tr. at 396, 397, 465; CMS Ex. 17, at 15; and

�Petitioner failed to have equipment available in order to ventilate and suction the resident. ⁽¹⁷⁾ CMS Ex. 13, at 103.

I conclude that Petitioner has not overcome CMS's showing that its facility was in violation of 42 C.F.R. � 483.13(c) (Tag F224) and 42 C.F.R. � 483.25(Tag F309) on August 28, 2002. In fact, the preponderance of the evidence clearly establishes that Petitioner was not in substantial compliance during the period at issue in this case.

V. CMS's finding of immediate jeopardy was not clearly erroneous.

The evidence strongly supports a finding of an immediate jeopardy level deficiency. It is not certain that R17 would have been spared by competent attempts at resuscitation. ⁽¹⁸⁾ That, however, as previously pointed out, is not dispositive of the issue at hand. The prima facie evidence offered by CMS establishes a manifest failure by the staff to comprehend its duties to a resident in distress and to perform resuscitation competently. What CMS needs to establish, and what it has in fact established, is that Petitioner's noncompliance caused or was likely to cause, serious injury, harm impairment or death. Additionally, Petitioner should have foreseen that the failure to adequately supervise R17 during meals as well as the failure to provide him with proper resuscitative care when found unconscious, would likely place him at risk of suffering serious harm, impairment or death.

Whatever opportunity R17 might have had to survive had he received appropriate care, vanished by the staff's incompetence. It is also proof that other residents were equally placed in jeopardy. The likelihood of extremely harmful consequences for Petitioner's residents existed as long as Petitioner's staff was not trained in the proper manner of responding to emergency situations requiring the application of CPR protocol. CMS Ex.12, at 149-175.

Immediate jeopardy exists where a provider's noncompliance with one or more requirements of participation has caused or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. � 488.301. For a finding of immediate jeopardy, it is not necessary to show the noncompliance caused serious harm; it is sufficient to show that the noncompliance was likely to cause serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001). Additionally, I must uphold CMS's determination as to immediate jeopardy unless it is clearly erroneous. 42 C.F.R. � 498.60(c)(2). Thus, it is not necessary for CMS to establish that R17 would have survived if the facility had been competent in handling his emergency. Petitioner's argument that CMS has not demonstrated the existence of immediate jeopardy is misplaced. The regulations provide that CMS's determination of immediate jeopardy must be upheld unless it is clearly erroneous. 42 C.F.R � 498.60(c)(2). The burden rests with the provider to prove that CMS's determination of immediate jeopardy is clearly erroneous. Petitioner has denied the existence of immediate jeopardy, but it has failed to come forward with cogent reasons for its contention.

VI. The amount of the penalty imposed by CMS is reasonable.

I have already amply discussed the basis for a finding of noncompliance. Indeed, there is not only a prima facie case of noncompliance here, but the preponderance of the evidence is that Petitioner was not complying substantially with the regulatory requirements under 42 C.F.R. � 483.13(c) and 42 C.F.R. � 483.25. Furthermore, Petitioner has not met its burden of showing that CMS's determination of immediate jeopardy is "clearly erroneous."

There is no issue as to the reasonableness of the CMP imposed, inasmuch as $3,050 is the permissible minimum under the regulations, where it is established that the participating facility has incurred a deficiency that reaches the level of immediate jeopardy. 42 C.F.R. � 488.438(a)(i).

VII. Burden of Proof

Petitioner contends that by placing reliance on Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Centerr, v. United States Department of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999), I have imposed an erroneous burden of proof on the facility. However, Petitioner fails to advance support for its contention. Furthermore, the allocation of the burden of proof is material only where the evidence is in equipoise, and the evidence in this case is not in equipoise. Fairfax Nursing Home, Inc. v. U.S. Dep't of Health and Human Services, 300 F.3d 835, 840, n.4 (7^th Cir. 2002), on appeal from Fairfax Nursing Home, Inc., DAB No. 1794 (2001), cert. denied 537 U.S. 1111 (2003).

VIII. Conclusion

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that Petitioner was not in substantial compliance at the immediate jeopardy level on August 28, 2002, and that the imposition of a $3,050 is reasonable.

José A. Anglada

Administrative Law Judge

1. See also Beverly Health & Rehabilitation-Springhill v. Health Care Financing Administration, DAB CR553 (1998).

2. At the hearing Ms. Tyus testified that it was at approximately 12:15 p.m. to 12:30 p.m. that she brought R17 his lunch tray. However, the chronology of events that will de discussed reveals that this information cannot be correct.

3. A high Fowler's position is when a position bed is placed at approximately 90� angle so that the resident is almost sitting up in the bed.

4. R17 was in the west wing. Tr. at 106.

5. Of course, inasmuch as Ms. Tyus was CPR trained she could have also begun resuscitative care immediately while Ms. Balderas called 911 and alerted the staff to a Code Blue. CMS Ex. 12, at 210.

6. Petitioner's fact witnesses have given inconsistent information throughout these proceedings. Whereas Ms. Balderas had informed Mr. Gaffud that she had left R17 alone after sending Ms. Tyus for the floor nurse, in order to check his DNR status, call his doctor, call Code Blue, and call the paramedics, she stated at the hearing she waited for Ms. Tyus to return. Tr. at 123, 617-618.

7. I noted above that when Ms. Tyus returned to get Ms. Adams for a second time, a few minutes later, she told her that the resident was dead. This points to the possibility that Ms. Tyus went all the way to R17's room before going for Adams for the second time. CMS Ex. 13 at 103 (duplicate at page 109).

8. The paramedics that arrived on the scene employed Magill forceps to clear the airway.

9. Ms. Balderas, the supervisory nurse, had already determined that R17 had no pulse. Ms. Balderas' finding is consistent with Ms. Adams' entry in the nurse's notes on April 13, 2002, where she stated that the resident was pulseless.

10. It is uncertain what Ms. Adams meant by unsuccessful attempt at resuscitation, in the face of her admission that she gave the resident no rescue breaths. As a care giver certified to perform basic life support, Ms. Adams should know that proper ventilation of R17 was critical in his moment of emergency. CMS Ex. 12, at 234.

11. I am proceeding here under the assumption that it is true that Ms. Adams was in the process of providing care to R17. Of course, she must have been far from putting thought to action, because the paramedics reported that upon arrival no one was administering CPR to the resident. CMS Ex, 12 at 51.

12. Ms.Balderas testified that when an individual is having a choking episode, he/she must turn blue. Tr. at 659.

13. I infer that the underlying cause is the most important to the task of maintaining accurate vital statistics, and the allocation of health resources.

14. Dr. Wolf admitted in a note that he made for the record that although the facility staff put him on notice of the resident's unresponsiveness on April 13, 2002, he was not made aware that the paramedics had found an airway obstruction. CMS Ex.13, at 21.

15. The emergency room physician did not establish a cause of death nor indicate an awareness of the resident's choking incident. In the diagnosis section it was indicated that the resident was brought to the ER in cardiac arrest (which, of course, resulted from choking, according to the paramedic report). See CMS Ex. 12, at 51; CMS Ex. 13, at 8.

16. Ms. Tyus did know that R17 had food in his mouth, yet the credible evidence of record shows that she did not convey that information to the paramedics. It is a sad commentary on the facility's commitment to provide adequate care to the resident, that knowing that R17 had food in his mouth when found unresponsive, she did not proceed immediately to remove it.

17. Ms. Balderas testified that the paramedics suctioned R17 with the suction machine taken from the facility cart, but that was contradicted by the paramedics who testified that they used their own equipment. Tr. at 629, 543, 869,870.

18. Although it cannot be said with absolute certainty that R17 would have survived with competent emergency care, Dr. Wesiberg did state that in a choking situation if ventilation occurs immediately, the chance of survival is extremely high. Tr. at 416.