SUBJECT:

Delmar Gardens of Chesterfield,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Delmar Gardens of Chesterfield, is a long-term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS) determination that it was not in substantial compliance with participation requirements. For the reasons discussed below, I find that Petitioner was in substantial compliance with participation requirements at all relevant times. Thus, CMS is not authorized to impose any remedies against Petitioner.

I. Background

An abbreviated complaint survey done by the Missouri Department of Health and Senior Services (State agency) found Petitioner out of compliance with 42 C.F.R. � 483.25 (F Tag 309 on the November 5, 2004 statement of deficiencies) at an immediate jeopardy level. Based on this survey, CMS imposed as remedies against Petitioner a per instance civil money penalty (CMP) of $10,000 and a denial of payment for new admissions (DPNA).

By letter dated January 7, 2005 ⁽¹⁾, Petitioner timely requested a hearing. The case was assigned to me for the hearing, related proceedings, and decision. I scheduled a hearing to commence on August 8, 2005. However, by unopposed motion dated June 22, 2005, Petitioner waived its right to appear and present oral testimony at an in-person hearing and requested that the case be argued on a written record. I granted Petitioner's request by order dated June 30, 2005, and set a briefing schedule. CMS filed a brief (CMS Brief), to which Petitioner responded (P. Brief). CMS did not file a reply.

CMS offered four exhibits (CMS Exs. 1-4). Petitioner objected to CMS Exs. 1, 2 (at pages 10-70), 3 (at pages 1-63 and 119-40), and 4 (at pages 4-46). CMS never responded to Petitioner's objections. Petitioner objects to CMS Ex. 1 because it contains information of an unsubstantiated complaint visit at a different time and concerning a different resident and subject matter than the issue before me. I sustain the objection to CMS Ex. 1 and am not admitting the exhibit. CMS Ex. 2, at pages 10-70, also concerns a different resident, time and subject matter and I am not admitting those pages of the exhibit. CMS Ex. 3, at pages 1-63, also refers to a resident unrelated to the Resident in question. I do not admit these pages either. However, I am admitting CMS Ex. 3, at pages 119-40. Although these pages may, as Petitioner asserts, discuss only subsequent remedial measures taken by the facility, they relate to the incident in question and I do not find them prejudicial. Finally, I am admitting CMS Ex. 4, pages 4-46, because they are the surveyor notes at issue, hearsay is admissible in an administrative proceeding, and they are relevant. Accordingly, I admit CMS Ex. 2, but not pages 10-70; CMS Ex. 3, but not pages 1-63; and CMS Ex. 4. I admit Petitioner's exhibits (P. Exs.) 1-58. ⁽²⁾

II. Issue

Whether Petitioner was out of substantial compliance with participation requirements.

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for long-term care facilities (Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (NFs)) participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing long-term care facilities participating in the Medicare program are found at 42 C.F.R. Parts 483, 488, 489, and 498.

To participate in the Medicare program, a long-term care facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a DPNA and a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements, or for each instance that a facility is not in substantial compliance. 42 C.F.R. �� 488.430(a), 488.440.

IV. Burden of Proof

As an evidentiary matter, CMS must set forth a prima facie case that a facility is not in substantial compliance. Petitioner then has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), applying 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). I follow this precedent in making my decision here. Moreover, as I discuss below, although CMS made a prima facie case that Petitioner was not in substantial compliance with participation requirements, Petitioner has successfully rebutted CMS's prima facie case and proved by a preponderance of the evidence that it was in substantial compliance with participation requirements.

V. Findings of Facts, Conclusions of Law, and Discussion

I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding below, in italics, as a separate heading. I discuss each finding in detail.

1. Petitioner was in substantial compliance with the participation requirement at 42 C.F.R. � 483.25 (F Tag 309) as of the survey ending on November 5, 2004.

Section 483.25 of 42 C.F.R. requires that each resident of a facility must receive, and the facility must provide, the necessary care and services to attain or maintain a resident's highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. The State agency surveyors found that this requirement was not met based on a complaint investigation survey of Petitioner which ended on November 5, 2004. The survey found an immediate jeopardy level violation at F Tag 309, relating to a Resident, referred to below as Resident 1, who died at the facility on the morning of September 29, 2004. Specifically, the survey found that Petitioner failed to provide timely cardiopulmonary resuscitation (CPR) to Resident 1, a Resident who had an order for a "full code" response to interrupted breathing or heartbeat. ⁽³⁾ P. Ex. 1; CMS Ex. 2, at 1-9; CMS Ex. 3, at 76-84. ⁽⁴⁾

Resident 1 had a lengthy list of admission diagnoses including cerebrovascular disease, congestive heart failure, and hypertension. CMS Ex. 4, at 54. Resident 1 had undergone a coronary artery bypass graft surgery on July 21, 2004. Id. at 101. His nursing assessment on September 13, 2004, showed he had a well-healed mid-sternum incision. Id. at 54. His physician's order indicated that he was a "full code." Id. at 88. His CPR directive, dated September 15, 2004, indicated that CPR was to be instituted in the event of a cardiopulmonary arrest. Id. at 48, 100. The form also showed CPR would be administered by trained staff who would do mouth-to-mouth or mouth-to-mask resuscitation and perform chest compressions in an attempt to revive the resident. Id. The form also showed that once CPR was instituted staff had to call 911 emergency services. Id.; See CMS Ex. 3, at 76-77.

The incident in question occurred on the morning of September 29, 2004. The contemporaneous documentation regarding this incident includes a nurse's notes and a run report by paramedics who answered the 911 call. Specifically, the nurse's note dated September 29, 2004, at 8:05 a.m., which was written by Cameo Moeller, LPN, states:

This nurse called to [Resident's] room [at] 7:30. CNA stated was in [Resident's room at] 0710 [and Resident] awake [and] alert. Upon entering [room] observed that [Resident's] chest not rising [and] falling. [No] heartbeat noted [and] pulse [not] able to be obtained. Skin warm to touch. Pupils dilated. 911 called [and] Dr . . . Sertl also notified. [Resident] ambued [and] chest compressions done [with no] response for [approximately] 15-20 minutes before 911 arrived. Code cancelled per paramedics as [no] heartbeat via EKG [and] d/t length of time [with no oxygen]. . . .

CMS Ex. 4, at 99. The record of the Monarch Fire Protection District for that date shows that they received a 911 call at 7:26 a.m., arrived at the facility at 7:29 a.m., and departed at 7:49 a.m. The report recites:

2217 responded to a cardiac arrest. We arrived at the [patient's] room to find the Nursing Home Staff doing CPR. There is no pulse and no resp. Eyes are fixed and dilated with no response to light. Skin is cool and dry to the touch. The NHS states that the [patient] has been down [approximately] 20 min. They stated they have been doing CPR for [approximately] 6-8 min. As the cardio monitor pads [were] being placed on the [patient] I received a pt hx. The monitor shows a PEA at 29 bpm with no pulse, no resp and cyanosis to the chest, abd., lips and neck . . . Dr. Worster was contacted. I advised her of the situation and asked her if I could call the cardiac arrest. She agrees. A second strip was run which shows asystole x/6. Time of death was 07:39 am on 9-29-04. The NHS states that the [patient] has just went through CABG last week and had his tracheostomy closed. He had no complaints at [approximately] 0710 am which was the last time the RN spoke to him.

P. Ex. 15, at 1. The run report also notes that an ECG lead was placed on Resident 1 at 7:34 a.m. P. Ex. 15, at 2. Thus, according to the contemporaneous documentation, the entire incident occurred between 7:10 a.m., when Resident 1 was last seen prior to his cardiopulmonary arrest, and 7:39 a.m. when he was declared dead.

To explain what happened in those 29 minutes, CMS relies on the statement of deficiencies, which is based on surveyor notes of interviews the State agency surveyors conducted in person and by telephone (and, to a lesser extent, documents they obtained at the facility) approximately a month after the incident in question. CMS submitted no surveyor affidavits regarding the surveyors' notes or the surveyors' investigation, and did not submit affidavits from any of the nursing personnel involved in the incident, or from the two physicians interviewed, or from any other nurses or physicians, to provide first-hand evidence on the incident or to opine on the appropriate standard of care. These surveyor notes are hearsay. However, while these unattested surveyor notes are hearsay, since hearsay is admissible in administrative hearings, I have admitted them and rely on them at least insofar as they underpin CMS's prima facie case. Based on this evidence (which I discuss fully below), I find that CMS has made a prima facie case, albeit tenuous, that Petitioner was not in substantial compliance with participation requirements, as the evidence it presented was sufficient to establish the fact of noncompliance or raise such a presumption, unless disproved or rebutted. However, as I also find below, Petitioner submitted affidavits from the individuals directly and personally involved in Resident 1's care that morning, and other evidence, which rebuts CMS's prima facie case. Thus, Petitioner prevails based on a preponderance of the evidence presented. ⁽⁵⁾ Immediately below, I set out and discuss the alleged facts described in the statement of deficiencies and the surveyor notes on which they are based.

LPN Moeller (Nurse A) was interviewed by a surveyor at 8:30 a.m. on November 2, 2004. P. Ex. 1, at 2-3; see surveyor notes at CMS Ex. 4, at 37-38. LPN Moeller informed the surveyor that she was the first to respond to Resident 1's room. The Resident did not have a pulse or heart beat and did not appear to be breathing. The Resident was warm and pale and the Resident's warmth and color appeared normal. LPN Moeller went to the desk, checked Resident 1's code status, called a STAT code, and went back to the Resident's room with the "crash cart." LPN Moeller told the surveyor that Nurses B, C, D, E, and F responded. LPN Moeller relayed that Naomi Jessup, RN (Nurse B) (CMS Ex. 37, at 4; see P. Ex. 8), then the Assistant Director of Nursing (ADON), lifted Resident 1's shirt and saw an incision line. LPN Moeller said the nurses had a one-to-two-minute discussion regarding whether to do CPR because of Resident 1's incision line. RN Jessup started CPR, doing light chest compressions, and Michele Mack, RN (Nurse C) (CMS Ex. 37, at 4; P. Ex. 9) did the respirations with the "ambu bag." ⁽⁶⁾ The statement of deficiencies then documents two observations not reflected in the surveyor's November 2, 2004 survey notes: that LPN Moeller declared that Nurse G said the Resident 1 "is a full code, we have to do something," and that the Resident's incision was "totally healed, not even scabbed over." P. Ex. 1, at 3; CMS Ex. 4, at 37-38.

During an interview with a surveyor on October 26, 2004, at 11:52 a.m. (P. Ex. 1, at 3; CMS Ex. 4, at 6-7), RN Mack told the surveyor that after a couple of minutes of discussion the nurses decided to perform CPR. RN Mack knew that CPR should not be done on a person with a fresh sternotomy (incision through the sternum) due to the risk of fracturing the sternum again. RN Jessup did the chest compressions, but RN Mack did not know who did the respirations. RN Mack wanted the nurses to know that CPR should not be done on a resident with a fresh sternotomy. During an interview with a surveyor on November 4, 2004, at 12:35 p.m. (P. Ex. 1, at 3; CMS Ex. 4, at 39), RN Mack said the nurses had a one-to-four-minute discussion before they started CPR. The nurses continued CPR until the paramedics arrived. RN Mack recalled that she performed the respirations on the Resident. Id.

During an interview with a surveyor on November 2, 2004, at 7:45 a.m. (P. Ex. 1, at 3-4; CMS Ex. 4, at 34), RN Jessup told the surveyor that Resident 1 was pulseless and breathless. CMS Ex. 4, at 34. RN Jessup lifted Resident 1's shirt and saw the midline incision. RN Jessup and RN Mack discussed, while doing CPR, whether they should do the compressions very hard. The statement of deficiencies recites that it was one to two minutes before they started CPR (P. Ex. 1, at 4) but that statement is not reflected in the record of the discussion RN Jessup allegedly had with the surveyor. CMS Ex. 4, at 34. They did not stop CPR until the paramedics arrived.

The statement of deficiencies conflicts with the surveyor notes with regard to interviews of LPNs Mona Woodworth and Ann Loraine. The statement of deficiencies references an interview of November 2, 2004 at 1:55 p.m. The surveyor notes show that this interview was with LPN Woodworth. However, the information contained in the statement of deficiencies appears to come from an interview of November 2, 2004 with LPN Lorraine instead. And, where the statement of deficiencies references an interview of November 2, 2004, at 12:50 p.m., the surveyor notes show that interview was with LPN Loraine, but the information contained in the statement of deficiencies appears instead to have come from the interview with LPN Woodworth. P. Ex. 1, at 3-4; CMS Ex. 4, at 14-15, 18.

The interview with LPN Woodworth on November 2, 2004, at 1:55 p.m., as reflected in the surveyor note, states that LPN Woodworth said RN Jessup "call[ed] the shots," that the Resident was "gone," and that they were not going to do CPR on him. Further LPN Woodworth recalled that she was in the room roughly five to 15 minutes. CMS Ex. 4, at 18; see P. Ex. 1, at 4.

The interview with LPN Loraine on November 2, 2004, at 12:50 p.m., as reflected in the surveyor note, states that she was one of the last nurses to arrive in the Resident's room. LPN Loraine stated that RN Jessup and RN Mack were at the head of the bed and discussed the Resident's history. LPN Lorraine stated that she told RN Jessup and RN Mack that 911 had been called. LPN Loraine saw RN Jessup perform light chest compressions with bent elbows instead of straight arms. LPN Loraine looked to the registered nurses for guidance and the event made her uncomfortable. CMS Ex. 4, at 14-15; see P. Ex. 1, at 4. LPN Loraine was interviewed by the surveyors again on November 4, 2004. LPN Loraine stated that both RN Jessup and RN Mack discussed for three or four minutes feeling uncomfortable doing chest compressions on Resident 1 and did not start CPR. LPN Loraine left the room. LPN Loraine went out in the hall to assist LPN Moeller. When she walked back into the room, RN Jessup and RN Mack had decided to start CPR, but it took them two to three minutes to do so because they were struggling with the ambu bag, perhaps because the tubing did not fit. LPN Loraine said it took them five to seven minutes to start CPR. CMS Ex. 4, at 42.

The statement of deficiencies reflects an interview of November 8, 2004, at 8:40 a.m., with Katherine Allsmiller, LPN (Nurse K). P. Ex. 1, at 5; CMS Ex. 4, at 35. The statement of deficiencies reflects that when LPN Allsmiller arrived in Resident 1's room there were about eight people there arguing that they did not want to do CPR because the Resident had had open heart surgery. LPN Allsmiller stated she told them the Resident was a full code, 911 had been called, and they needed to start CPR before the paramedics arrived. When she left the room the nurses were trying to figure out the ambu bag. She ran into the paramedics in the hall. She said the Resident was a full code and it should not have mattered if he had open surgery. She said she was in the room one to five minutes and the staff were not performing CPR. Id.

The statement of deficiencies reflects that on November 1, 2004, at 1:35 p.m., a surveyor interviewed James Sertl, M.D. (Physician A). Dr. Sertl said he was not aware of the discussion the nurses had prior to starting CPR. He said if a person is a full code 911 should be called and CPR initiated immediately. There should not be a discussion. He said Resident 1 had surgery about eight weeks prior to the incident and it was o.k. to do CPR. The Resident's sternum remained wired. P. Ex. 1, at 5; CMS. Ex. 4, at 36.

The statement of deficiencies reflects that on November 1, 2004, a surveyor interviewed Steven Eisenberg, M.D. (Physician B), Resident 1's cardiac surgeon. P. Ex. 1, at 5-6; CMS Ex. 4, at 43-44. Dr. Eisenberg saw Resident 1 the Monday before the incident and the Resident was making significant progress. Dr. Eisenberg said the nurses should have initiated CPR immediately and there should not have been any discussion before starting. He said it was acceptable to do CPR on a patient post-op sternotomy and that CPR is done on patients three to five days post-op. The only time CPR is not done is if someone is not a full code or their chest is open and heart exposed. If CPR isn't done, the alternative is death. He said the nurses made the wrong decision. He assumes that when he sends his patients to a nursing home they know what to do and respond to the best of their ability.

CMS asserts, based on the statement of deficiencies incorporating the surveyors' interviews with the facility nurses and the two physicians, ⁽⁷⁾ that Petitioner's staff's incompetence presented a situation of immediate jeopardy to Resident 1. CMS asserts that from two to seven minutes were wasted while staff looked up Resident 1's code status and debated whether to perform chest compressions because he was post-op sternotomy. These wasted minutes should have been spent performing CPR and could have made a difference in the outcome. CMS argues that whether or not the staff's failure to competently begin and continue CPR on Resident 1 directly caused his death is not the issue. The issue is whether the staff's confusion, delay, improper technique and faulty equipment might have caused serious harm to Resident 1. CMS Br. at 8-10.

CMS refers to the case of Royal Manor, DAB CR1185 (2004), aff'd DAB No. 1990 (2005), in support of its allegations. In that case CMS had alleged that the way in which that facility's staff dealt with a resident's episode of respiratory distress demonstrated that it was incapable of competently responding to the emergency, in that the facility: wasted time before providing emergency resuscitation; displayed a lack of knowledge of the requisite techniques for performing CPR and failed to perform CPR appropriately in an emergency situation when correct use might have saved a resident's life; failed to maintain suctioning equipment in a proper manner; failed to suction a resident's airway while the resident was aspirating, endangering his life; and failed to provide necessary information to emergency medical services. The administrative law judge in that case found CMS made a prima facie case that the facility had shown a gross failure to provide necessary services and that minutes were lost while the staff attempted to determine whether the resident was a DNR or a full code. The staff wasted more time after the resident's resuscitation status was established while employees debated what to do with the resident. The Departmental Appeals Board (Board) found that unrebutted professional nursing standards in evidence established that health care providers dealing with a patient in respiratory distress are to assess need, call 911, and begin the sequence of CPR resuscitation quickly when confronted with a patient with absent or inadequate breathing. Royal Manor, DAB No. 1990, at 6. The DAB noted that the nurses failed to comply with nursing practice standards by delaying initiation of CPR, failing to clear the resident's airway before attempting artificial respiration, and by abandoning CPR efforts once begun. Id. at 8.

If I accept the surveyors' notes as an accurate reflection of the facts, then CMS has made a prima facie case that confusion and delay attendant to the facility's response to Resident 1's code contravened the participation requirement. I note that CMS had the opportunity to call the surveyors, the facility staff, and the physicians involved to testify. CMS chose not to do so. Petitioner, as discussed below, has rebutted CMS's case with sworn affidavits (as opposed to the unsworn hearsay submitted by CMS) of those involved in the incident, and their sworn testimony, coupled with LPN Moeller's nurse's note and the Monarch run report, convinces me that Petitioner was in substantial compliance with participation requirements. ⁽⁸⁾

In its Royal Manor decision, as noted above, the Board adopted a standard for resuscitation stating that "[u]nrebutted professional standards in evidence establish that health care providers dealing with a patient in respiratory distress are to assess need, call 911, and begin the sequence of CPR resuscitation quickly when confronted with a patient with absent or inadequate breathing." Royal Manor, DAB No. 1990, at 6. CMS relies on the Royal Manor decision, and the evidence adduced by Petitioner supports this as the professional standard of care for resuscitation. See P. Ex. 29; P. Ex. 26; P. Ex. 20, at 2. The affidavits of the individuals involved in this incident show that Resident 1 was assessed, 911 was called, and the nurses began the CPR sequence quickly and did not stop CPR until the paramedics arrived. I note here the argument CMS makes that confirming Resident 1's code status before instituting CPR indicated noncompliance. However, there is no evidence here that an unduly long time was taken in checking the Resident's code status and a facility must check a resident's code status to ensure that they do not attempt resuscitation on a resident with a do not resuscitate (DNR) order. See also Sunbridge Care and Rehabilitation for Escondido East, DAB CR891, at 32 (2002).

The contemporaneous documentation referred to above (the nurse's note prepared by LPN Moeller and the run report prepared by the paramedics) reflect that Resident 1 was assessed, 911 was called (at 7:26 a.m.), and CPR was instituted and ongoing when the paramedics arrived at the facility (at 7:29 a.m.). CMS Ex. 4, at 99; P. Ex. 15, at 1. The affidavits of the personnel involved also support this chronology of events.

The two nurses most involved in the resuscitation attempt were RN Jessup and RN Mack. Both nurses had lengthy nursing experience (RN Jessup 44 years and RN Mack 20 years) and both were certified in CPR. P. Ex. 8, at 1; P. Ex. 9, at 1. ⁽⁹⁾ Both of their statements are consistent in showing that Resident 1 was assessed and CPR was begun quickly and continued until the paramedics arrived.

RN Jessup's affidavit ⁽¹⁰⁾ states:

Soon after I arrived for work on 9/29/04 I heard a "stat" page to the 2 Sub division. I immediately left the 300 division and went to 2 Sub. When I entered the room I heard Mary Daniel, CNA, say she had seen the resident at 7:10 and he was fine. I was familiar with the resident, Resident 1 as a resident in the Facility for about two weeks. I asked Mary if he was restless and she repliend, "No more than usual.". . . Resident 1 appeared very white, as if he had bled out. I touched his arm and he was barely warm; he certainly did not feel as warm as he had when I touched him in the past while providing care to him . . . I went to the left side of the resident's bed. I could smell bowel movement. I first opened his left eye, then his right. Both pupils were fixed and fully dilated. His mouth was open; his jaw was relaxed. His tongue was white. Both sides of his neck were cyanotic . . . Resident 1 was extremely diaphoretic, indicating to me from my extensive nursing experience that something big and stressful happened to [him], such as a myocardial infarction, stroke or pulmonary embolus . . . From my nursing experience I knew as soon as I entered the room that Resident 1 was dead. My assessment confirmed this. Nothing we would do was going to make a difference or reverse the death . . . However, this belief did not stop me from proceeding to start CPR. I gave two breaths with the ambu bag and one chest compression before Michele Mack, RN, arrived in the room. Michele and I discussed the fact that Resident 1 had recent cardiac surgery. This discussion took place while we were simultaneously starting CPR . . . Michele took over the ambu bag and I did chest compressions. Oxygen from the E-tank (on the emergency cart) was attached to the ambu bag at this time. No one removed the oxygen that he was receiving by nasal cannula via the concentrator that I can recall. I gave strong chest compressions, feeling the sternum pressing against the heart. The EMS ambulance, which included three male paramedics, responded quickly and took control of the situation . . . One paramedic pulled the foot board off the bed as he was pulling the bed from the wall, making for a dramatic entrance. Another paramedic placed electrodes from the defibrillator paddles on Resident 1['s] chest and told the Facility staff to stop CPR. The EKG strip showed one small spike that the paramedic said was bed movement. Otherwise, the strip showed asystole. The paramedic asked when we last saw him alive. Someone said 7:10 a.m. The paramedic said he had been down too long. I believe the paramedic called a hospital contact/physician who gave the paramedic final instructions to stop the code. CPR was not restarted after the paramedic said to stop and ran the EKG strip . . . I remained in the room for the entire code process. It is not possible that the ambulance took 15-25 minutes as some who were in and out of the room said. A fairly accurate estimate of time from when I entered the room to when the paramedics stopped the code is three to five minutes. I know from experience that time in a code situation means nothing. I can understand that others might perceive the amount of time differently. A code is a highly stressful situation and the additional adrenaline can alter persons' perceptions. I strongly disagree with the DHSS surveyor's conclusion in the 11/[5]/04 Statement of Deficiencies that "staff discussed for several minutes if they should perform chest compressions." This statement is not correct. Instead, any hesitation and discussion only lasted seconds while we simultaneously prepared to start CPR.

P. Ex. 8, at 1-2.

RN Mack's affidavit states:

On 9/29/04 at about 7:30 a.m. I entered the Facility through the side door by the time clock. As I entered, someone told me that a "stat" had been called on the 2 sub division . . . I ran quickly to the room. I remember Naomi Jessup, RN and Assistant Director of Nursing, was already in the room checking for vital signs. Someone said the resident was not breathing and without vital signs. I saw Resident 1 laying flat on the bed. I was familiar with [him] from previous contacts with him in the Facility. Resident 1 was obviously dead. His neck and head looked bluish. His face had no muscle tone. His pupils were fixed and dilated. His legs and body were mottled. His skin was cool, but not stone cold . . . When someone lifted Resident 1's shirt I saw that he had had recent coronary bypass surgery. Memories from the telemetry nursing flooded back and I said something like "Oh my gosh. We cannot do CPR on this man with a recent CABG. We will do more damage." I remember Naomi agreed with me and repeating what she said. This was a very brief conversation before we started CPR; almost talking out loud as we simultaneously prepared to do CPR. I would describe the code as a blur where time meant nothing. Naomi told me later I was at the head of the bed, but I do not remember. When the paramedics arrived they stopped everything. They ran an EKG strip by placing defibrillator pads on the resident. The strip showed asystole. The paramedics stopped the code . . . After the paramedics stopped the code I helped roll Resident 1 to his side to clean up the incontinent stool. I noticed his legs were mottled. He had been extremely diaphoric leaving the sheets soaked with perspiration. Also, the diaphoresis indicated to me that a traumatic event had occurred . . . I was interviewed at the Facility and then by phone by a surveyor from the Missouri Department of Health and Senior Services. The surveyor did not use open-ended questions. Instead the surveyor had a list of questions. I could tell from the questions that the surveyor had talked to others and was going on what others had said. I felt threatened by the surveyor's questions and overwhelmed by the situation. I became very emotional during the interview. The surveyor later telephoned me to ask questions about time. The surveyor asked multiple choice questions such as "would I say it took 1 to 4 minutes for Naomi to start CPR?" I agreed to this statement but I strongly believe it was closer to one minute. In addition, the discussion occurred simultaneously with getting everything organized to start CPR. I have read the 11/[5]/04 Statement of Deficiencies where my interview with the surveyor is mentioned. See page 3, last paragraph. I strongly disagree with the comment that there was "a couple of minutes of discussion the nurse decided to perform CPR on resident # 1." . . . Nothing the nurses could have done during this code would have changed the outcome of Resident 1. Based on my experience, he was irreversibly dead when I entered the room.

P. Ex. 9, at 1-2.

LPN Woodworth's affidavit states that:

When I arrived on the 2 sub unit I saw Ann Loraine, LPN, Naomi Jessup, RN, Michele Mack, RN, and Cameo Moeller, LPN, present in the room. I saw Naomi by the window and Ann by the bathroom door. When I entered the room I did not have a good view of the resident. The resident was not a resident that I knew . . . I looked for some way to assist. When I realized that I could not be of any assistance, I excused myself and returned to the 300 hall to assist my tube-feeding patient. I estimate that I remained at the code no longer than 5 to 7 minutes . . . While I was present in the room I did not hear any discussion about coronary bypass surgery. In fact, I was not aware that the resident had a recent CABG procedure until I attended a later Facility inservice. I did not observe or hear anyone questioning anything occurring during the code . . . I was interviewed at the Facility by surveyors from the Department of Health and Senior Services. I remember a surveyor asking whether equipment worked during other codes. I told the surveyors that at one time the Facility had older equipment that made hookup difficult. However, this older equipment had been replaced before the 9/29/04 code.

P. Ex. 12, at 1-2. I observe that the surveyor notes reflect that LPN Woodworth was in the room five to 15 minutes. Given that the paramedics were called at 7:26 a.m., arrived at the facility at 7:29 a.m., had attached an EKG lead by 7:34 a.m., and declared the Resident dead at 7:39 a.m., the latter estimate of time set out in the surveyor notes does not seem plausible, and I find that it is unreliable.

LPN Loraine's affidavit states that:

All codes that I have witnessed at the Facility have been performed without discussion or question except for one on 9/29/04. In that case, there was discussion about the resident's recent open heart surgery. When a "stat" is called all licensed nurses in the building respond and assist in any way needed. The nurses continue CPR until paramedics arrive . . . On 9/29/04 I responded to "stat" page on the 2 Sub unit of the Facility. I believe I was one of the last nurses to arrive . . . When I arrived in the room I saw Naomi Jessup, RN and Assistant Director of Nursing, who appeared to me to be in charge of the code. She stood at the head of the resident's bed assessing the resident and checking for pulses. I was not familiar with the resident . . . My immediate impression when I saw the resident was that he was visibly dead, very pale with blue lips. Based on my long time experience viewing death, I knew he had been dead at least 20 minutes . . . The nurses in the room had opened the resident's shirt and I could see a visible chest scar. I heard the nurses discussing if CPR could damage the heart since there were wires present in his chest from recent surgery . . . I observed from the door as nurses began compressions. I did not assist in CPR, only observed from the door. I did not touch the resident . . . Since there were two registered nurses in the room with hospital experience directing the code, I left the room. I talked to Cameo Moeller, LPN briefly and then went back to my unit. I was not present when paramedics arrived.

P. Ex. 10, at 1-2. Given that LPN Loraine was the last to arrive at Resident 1's room, and based on the times stated in the run report, the timing in the chronology set forth in the surveyor notes regarding the surveyor's conversation with LPN Loraine does not seem plausible, and I find that it is unreliable.

The preponderance of the evidence is that Resident 1 was last seen alive at 7:10 a.m., was found by LPN Moeller by 7:26 a.m., when Resident 1's code status was checked, a stat code was called, and 911 was contacted. RN Jessup responded to the call, assessed the Resident and began performing CPR with the assistance of RN Mack. While the nurses may have discussed Resident 1's heart surgery, the preponderance of the evidence convinces me that their discussion took place as they began to administer CPR. Paramedics arrived three minutes after being called, at 7:29 a.m., and, upon entering the room moments later, found RN Jessup and RN Mack doing CPR. By 7:34 a.m. the paramedics had placed cardio-monitor pads on the Resident and, at 7:39 a.m., he was declared dead. I do not find this to be outside the standard of care or participation requirements. Petitioner has overcome CMS's prima facie case and, thus, was in substantial compliance with participation requirements at all relevant times.

2. As I find Petitioner to be in substantial compliance with participation requirements, I do not address the legal arguments raised by Petitioner in its hearing request and brief. P. Br. at 23-29.

VI. Conclusion

I conclude that Petitioner was in compliance with participation requirements at all relevant times. Thus, CMS was not authorized to impose remedies.

Richard J. Smith

Administrative Law Judge

1. The hearing request is actually dated January 7, 2004, but I construe the 2004 date to be an inadvertent mistake.

2. The parties only submitted two copies of the exhibits, one for me and one for the attorney assigned to the case. They did not submit the record copy, presumably because that copy would have been offered for admission at the hearing initially scheduled. I am placing my copy of the exhibits in the record as the record copy.

3. The statement of deficiencies also refers to inadequacies in Petitioner's CPR policy. P. Ex. 1, at 6-9. CMS did not refer to this in its briefing and thus I do not consider it here.

4. After informal dispute resolution, the State agency revised the November 5, 2004 statement of deficiencies. CMS Ex. 2, at 88-93. When discussing the revised statement of deficiencies below I will refer to P. Ex. 1.

5. The statement of deficiencies refers to facility staff and physicians by letter and the surveyor notes refer to them by name. The affidavits provided by Petitioner refer to facility staff by name. Neither party gave me a key to correspond the letter designations in the statement of deficiencies to staff names. Where possible I connect the letter designation to the staff name. However, this lack of correlation, especially on the part of CMS between the statement of deficiencies and the underlying surveyor notes, made it especially difficult for me to evaluate this case.

6. An "ambu bag" is a device which forces air into the lungs. It is used to ventilate a resident during resuscitation in place of mouth to mouth resuscitation. It can be used with or without additional oxygen. The oxygen content of room air is about 21 percent. However, expired air can also be used to resuscitate a victim of cardiac arrest by the use of mouth to mouth resuscitation. A person can be resuscitated without supplemental oxygen being hooked up to the ambu bag. P. Ex. 57, at 1, paragraphs 4, 5, 6.

7. Of course, the opinions of the two physicians were based upon what the surveyors told them the nurses did in responding to Resident 1's code and are, thus, of limited value.

8. Petitioner asserts that Resident 1 was irreversibly dead when discovered and that any alleged deficiencies could amount to no more than the potential for causing minimal harm. P. Br. at 9-10. This argument is irrelevant here on two counts. One, as I find Petitioner in substantial compliance there is no need for me to review the level of Petitioner's noncompliance and, two, my inquiry is whether Petitioner responded appropriately in attempting to resuscitate a resident who was a full code. However, were I to find it necessary to do so, based on the affidavits of the nurses and physicians Petitioner submitted, the preponderance of the evidence is that Resident 1 was already dead when the nurses began CPR, having not been seen for approximately 15 minutes (7:10 a.m. to 7:26 a.m. when 911 was called).

9. The unrebutted affidavit of Marianne Marcinkiewicz, RN, who is responsible for staff education and training at Petitioner, states that Petitioner's nursing staff receives regular education, updates and inservicing in emergency procedures, including regular CPR training and "mock code" inservicing. P. Ex. 57, at 1.

10. The affidavits are set out in numbered paragraphs. I do not include the paragraph numbers, as to do so would detract from the flow of the narrative and is unnecessary.