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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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| IN THE CASE OF | |
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Panola Care and Rehabilitation Center, |
DATE: December 24, 2003 |
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Centers for Medicare & Medicaid
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Docket No.C-03-218; C-03-248 |
| DECISION | |
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DECISION This case came before me pursuant to a request for hearing filed by Petitioner, Panola Care and Rehabilitation Center, on January 9, 2003. On January 3, 2003, the Centers for Medicare and Medicaid Services (CMS) informed Petitioner that it was imposing the following remedies pursuant to a survey conducted on October 30, 2002, by the Texas state survey agency:
ALJ Ex. 1. (1) CMS asserts, and Petitioner does not dispute, that on February 12, 2003, CMS rescinded all penalties except the per instance CMP in the amount of $5,000 that was specifically imposed for a violation of 42 C.F.R. § 483.10(b)(5)-(10). (2) CMS's brief at 1. On July 11, 2003, CMS filed a motion for summary judgment accompanied by a brief and 11 exhibits. I admit these exhibits into the record without objection as CMS Exhibits (CMS Exs.) 1-11. Petitioner submitted a reply brief in opposition to summary judgment on August 4, 2003, accompanied by 7 proposed exhibits. I admit these into the record without objection as Petitioners Exhibits (P. Exs.) 1-7. CMS filed a response to Petitioner's reply brief on September 9, 2003, accompanied by an additional exhibit consisting of an affidavit. In the absence of objection, I admit that document into the record as CMS Ex. 12. Based on the affidavits, other documentary evidence, the written arguments of the parties, and the applicable law and regulations, I find that on October 29, 2002, Petitioner was not in substantial compliance with Medicare/Medicaid participation requirements and that this noncompliance was at the immediate jeopardy level. I. Applicable Law and Regulations Petitioner is a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services. The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act, and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act invest the Secretary of Health and Human Services with authority to impose remedies of 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 of Health and Human Services 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. The applicable regulations at 42 C.F.R. Part 488 provide that facilities which 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 to 488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. §§ 488.300 to 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, and 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated. 42 C.F.R. § 488.440. The regulations specify that CMS may impose a CMP for an instance of noncompliance in the range of from $1,000 to $10,000. 42 C.F.R § 488.438(a)(2). A per instance CMP may be imposed regardless of whether or not the deficiencies constitute immediate jeopardy. 42 C.F.R. § 488.430(a). The regulations define the term "substantial compliance"to mean:
42 C.F.R § 488.301. "Immediate jeopardy" is defined to mean:
Id. The Act and regulations make a hearing available before an administrative law judge (ALJ) to a long-term facility against whom CMS has determined to impose a CMP. But the scope of such hearings is limited to whether an initial determination made by CMS is correct. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(12) and (13). The hearing before an administrative law judge is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd 941 F2d. 678 (8th Cir. 1991). II. Issues and Discussion
1. Whether the facility was complying substantially with federal participation requirements on October 29, 2002. 2. Whether the amount of the penalty imposed is reasonable, if noncompliance is established.
I make the findings of fact and conclusions of law (Findings) set forth below to support my decision in this case.
CMS contends that there are no material issues of fact in controversy and that this case may be disposed of by way of summary judgment without the need for an in person hearing. It is Petitioner's position that a genuine issue of material fact exists with respect to whether the facility was in substantial compliance. Unless the parties have raised a genuine issue of material fact, I may decide this case on summary judgment, without an evidentiary hearing. Livingston Care Center, DAB No. 1871 (2003); Crestview Parke Care Center, DAB No. 1836 (2002); Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1997); Carmel Convalescent Hospital, DAB No. 1584, at 27 (1996); See also Fed. R. Civ. P. 56 (summary judgment is appropriate when there is no genuine issue as to any material fact and the proponent is entitled to judgment as a matter of law). The Departmental Appeals Board recently reiterated in Livingston Care Center that:
Livingston Care Center, DAB No. 1871, at 6. In attempting to defeat a motion for summary judgment, a party may not rely on the denials of its pleadings, but is required to tender evidence of specific facts in the form of affidavits and/or other admissible documentary evidence, in support of its contention that a dispute exists. Crestview, DAB No. 1836, at 6 (citing Matsushita Elec. Ind. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n. 11 (1986)). Where a petitioner raises a factual dispute, an ALJ determines whether the facts are material by resolving all factual disputes in favor of the non-moving party (here, Petitioner). If after the ALJ has resolved all the factual disputes in favor of Petitioner, and nevertheless finds that CMS has established lack of substantial compliance justifying the penalties imposed, the disputed facts are not material and CMS is entitled to summary judgment. (3) CMS contends that Petitioner failed to comply with the requirement at 42 C.F.R. § 483.10(B)(5)-(10) and 42 C.F.R. § 489.100 with respect to advanced directives. According to CMS, the survey conducted on October 30, 2002, revealed that Petitioner's facility had systemic failures in documenting whether residents had do not resuscitate (DNR) status. This had the effect, states CMS, of placing in jeopardy residents' lives and decisions about their care. CMS further argues that the breakdown of the system became more evident when Resident #4 was found to be unresponsive and the facility took no steps for emergency treatment nor initiated cardiopulmonary resuscitation (CPR). CMS's brief at 5, 6; CMS Ex. 1, at 1-8. Petitioner contends that the grounds alleged by CMS for the cited deficiency in the Statement of Deficiencies is at variance with the regulatory requirements regarding advance directives. Thus, the citation for the facility's failure to initiate CPR on Resident #4 is inappropriate as it does not directly relate to advanced directives, and therefore, has no place being cited under Tag F156. Moreover, argues Petitioner, the Licensed Vocational Nurse (LVN) who discovered Resident #4 without vital signs made an appropriate decision by electing not to initiate CPR. Petitioner's brief at 4, 5; P. Ex. 7. The undisputed facts of this case reveal that on October 29, 2002, at 1:35 a.m. a member of the facility staff discovered Resident #4 in his bed, leaning back from a seated position, and with no vital signs. The staff member's first reaction was to notify Dr. Keeling, the resident's treating physician. The facility record further reflects that the physician ordered a DNR which the staff documented on a telephonic order form. The physician also ordered that facility personnel pronounce the resident dead and notify the family. At 2:30 a.m. a registered nurse pronounced the resident dead after determining that he had no pulse, respirations or heartbeat. CMS Ex. 6, at 2; CMS Ex. 9. Although not part of the entry made in the nurse's notes contemporaneous with the incident, Petitioner later learned that the resident's chart was consulted and it was discovered that he did not have DNR status so the initiation of CPR was expected. Petitioner's brief at 9. (4) Upon further inquiry into the matter CMS determined that the facility's policy required the initiation of CPR prior to checking the resident's chart for advance directives. CMS Ex. 7, at 2. For purposes of subpart I of 42 C.F.R. part 489, an advance directive means a written instruction such as a living will or durable power of attorney for health care, recognized under State law (whether by statute or case law), relating to the provision of health care when the individual is incapacitated. 42 C.F.R. § 489.100. The regulations further provide, at 42 C.F.R § 489.102(a)(2), that hospitals, critical access hospitals, skilled nursing facilities, nursing facilities, home health agencies, providers of home health care, and hospices must maintain written policies and procedures concerning advance directives with respect to all adult individuals receiving medical care by and through the provider, and those entities are required to document in a prominent part of the individual's current medical record whether or not the individual has executed an advance directive. Resident #4 had executed an advance directive where he had stipulated that if in the judgment of his physician, he was suffering from a terminal condition from which he was expected to die within 6 months, even with available life sustaining treatment provided in accordance with prevailing standards of medical care: all treatment other than to keep him comfortable was to be discontinued. The resident also elected to have all treatment except for comfort discontinued, if in the judgment of his physician, he were to suffer from an irreversible condition from which he was expected to die without life sustaining treatment. CMS Ex. 8. The facility advised the resident that under Texas law, he had a right to execute two other types of advance directives that could be important during a serious illness. These are the Medical Power of Attorney and the Out-of-Hospital Do-Not-Resuscitate Order. CMS Ex. 8. The resident, however, elected not to execute a DNR advance directive. I infer that this is the reason for Petitioner's belief that CPR was expected in the case of Resident #4. However, Petitioner argues that the LVN, VeNita Hudman, made it clear that when she entered the resident's room, she observed him to be ashen in color, with skin cool to the touch, without respiration or pulse. Thus, states Petitioner, as a licensed nurse, based on her training and experience, Ms. Hudman was able to recognize that the window of opportunity to save the resident with CPR had passed. She thus concluded that the resident was deceased. Petitioner's brief at 5. I find that what the LVN did was in fact pronounce the resident dead. That is something that under Texas law she was not empowered to do. Section 671.001 of Texas Statutes, Title 8, sets forth the standard used in determining death. The provision is as follows:
Clearly LVNs are not included among those health care providers that are authorized to make determinations of death. Thus, Ms. Hudman went beyond the scope of the duties Texas law authorized her to perform. Additionally, the cited law specifically provides that death must be pronounced before means of supporting a person's respiratory and circulatory functions are terminated. In the case at hand, death was pronounced without providing the resident with respiratory and circulatory support. Advance directives provide residents or their families in skilled nursing facilities and nursing facilities with the option of waving resuscitation measures when such resuscitation attempts, in certain circumstances, would lack sufficient benefit and merely prolong the process of dying, while causing unnecessary discomfort and emotional distress. Similarly, a resident who has not executed a DNR advance directive should have his or her wishes regarding medical care respected. In order to abide by the wishes of residents or their family, facilities must have clearly defined written policies regarding the implementation of advance directives. (5) In this regard, Texas law provides that all out-of-hospital settings must develop a DNR protocol that ensures that information regarding the existence of a DNR is entered into the patient's record, and an explanation of the patient identification process to include an option to use a department standardized identification device such as necklace or a bracelet. Texas Administrative Code, Title 25, Part 1, Chapter 157, Subchapter B, Rule § 157.25. In the case now before me, 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 Resident #4, to go through his medical chart to determine if he had a DNR order. In her affidavit, Ms. Hudman stated that when she found Resident #4 with no vital signs she immediately consulted his medical chart and determined that he did not have a DNR. (6) P. Ex. 2, at 1. At that moment, facility policy and Texas law regarding advance directives, required the application of resuscitative treatment. Texas Adm. Code, supra. However, the LVN wasted precious time by going to the phone to speak with the treating physician. Any opportunity to resuscitate the resident became more distant because of the time Ms. Hudman took to consult with the physician. (7) In view of the foregoing I find that the facility failed to clearly outline a DNR protocol that was properly communicated to its staff in a way that fostered an immediate DNR status determination and appropriate action consistent with that status. Although LVN Hudman stated that she immediately obtained the resident's chart, the surveyors found that facility staff would have to review each chart to determine if the resident actually had complete paperwork to identify them as a DNR resident. Thus, there was no system in place that allowed for the quick identification of residents who required emergency care. Petitioner submitted several affidavits from facility staff stating that they would go to the resident's chart to determine the DNR status. None of those affiants, however, reported how the facility maintained DNR information in a prominent place that permitted immediate determination without having to go through the chart. Their statements were vague as to how the facility kept the DNR information in appropriate section of each resident's chart. CMS Ex. 11, at 3-4. The system was so flawed that although no DNR order was found in the resident's medical chart, the nurse obtained a telephonic DNR order from the treating physician, in spite of having both agreed that the resident had already expired. CMS Ex. 9. This constituted not only a gross disregard of the resident's wishes, but also an egregious misapplication of advance directive protocol. The facility's deficiency not only affected Resident #4, but also placed other residents at risk of not having their advance directives honored or not receiving desired treatment in emergency situations. Pertinent to this is the surveyors' finding that the facility had systemic shortcomings in the identification of DNR status residents. The surveyors learned that the facility had developed a system of red or orange dot shaped stickers to reflect DNR residents. However, out of the 32 residents that were determined to be DNR, only 18 of them had stickers that identified them as such. This made it necessary for the nursing staff to review each chart to determine if the paperwork identifying the resident's DNR status was complete. CMS Ex. 11. The surveyors also noted discrepancies in the nursing staffs' approach to handling DNR matters. When interviewed about their understanding as to the action to be taken if a resident were to be found without vital signs, the nursing staff gave inconsistent responses:
CMS Ex. 10. Additionally, upon review, the surveyors noted that all the 58 residents were missing necessary paperwork, such as physician orders or DNR orders. Id. Some charts were incorrectly labeled, while others did not have the DNR status included in the care plan. Id. Consequently, there was no way of determining if a resident was DNR without conducting a record review. If the situation called for resuscitative efforts, the significant delay could mean the difference between life and death. CMS Ex. 10, at 3. In the case of Resident #4 the confusion was compounded when CPR was not initiated when a DNR order was not found in the file and the staff created a DNR order after the resident was deemed to have expired. This is particularly troubling inasmuch as the resident had not executed an out-of-hospital DNR. I conclude that CMS has established a prima facie case showing that the facility was not in substantial compliance with at least one of the participation requirements. Furthermore, I find that there is no dispute as to any material fact supporting CMS's prima facie case. Petitioner's argument that Resident #4 was beyond the point of resuscitation when found without vitals by the LVN, is without merit. The decision to withhold CPR against the wishes of the resident as well as the determination that he had reached the point of irreversible cessation of all spontaneous brain function was not within the purview of the LVN's authority. The situation did not call for the exercise of judgment on the part of the LVN. She had but one choice, and that was to initiate CPR in the most immediate manner, and without delay of any sort. It was not within her province to deliberate whether the effort would be futile or whether resuscitation activity would be traumatic. By not executing an out-of-hospital DNR, the resident had already made the decision to receive emergency treatment such as cardiopulmonary resuscitation in situations similar to the one that occurred on October 29, 2002, without regard to the physical trauma to the body. See Petitioner's brief at 5. Petitioner's additional contention that the nursing staff was not asked by the survey team whether or not they had experienced any difficulty in determining the DNR status of a resident in using the system in place prior to and on October 30, 2002, also lacks merit. P. Exs. 3-6. That argument is not relevant to the issues in this case, nor does it respond to the systemic problems found by the surveyors when they reviewed all of the residents' charts to determine if there was adequate documentation regarding resident DNR status. In sum, Petitioner has not overcome CMS's showing of a prima facie case by a preponderance of the evidence. Neither has Petitioner raised any issue of material fact that could permit me to decide otherwise.
I have found that CMS established a prima facie case that Petitioner was not in substantial compliance with federal requirements for long-term care facilities participating in the Medicare and Medicaid programs on October 29, 2002. I have also concluded that Petitioner has not overcome CMS's showing by a preponderance of the evidence. Furthermore, I sustain CMS's finding that Petitioner's level of noncompliance constituted immediate jeopardy. The evidence in this case establishes that Petitioner failed to comply with the requirements specified in subpart I of part 489 of 42 C.F.R. relating to maintaining and implementing written policies and procedures regarding advance directives. This requirement includes a written description of the facility's policy to implement advance directives and applicable State law as well as adherence to those policies. The record also depicts a failure to have a consistent policy and system in place in order to promptly identify those residents having executed an advance directive. The facility should have reasonably foreseen that a failure to properly apply the requirements of subpart I of part 489 of 42 C.F.R had the likelihood of causing harm, serious injury, impairment, or death to its residents. Petitioner's failed application of advance directive requirements caused or was likely to cause Resident #4, to suffer serious injury, harm, impairment or death. In this regard CMS asserts that the resident may have been revived if provided timely intervention. On the other hand, Petitioner argues that CMS's assertion is unfounded inasmuch as the argument is contrary to the eyewitness report of the LVN who deemed the resident to be already dead when found, as well as contrary to the opinion of the treating physician. Petitioner's brief at 9. I do not interpret CMS's position to be that had the facility initiated CPR, the resident would have survived, but rather, that any possibility of survival was lost by the facility's failure to provide immediate emergency care. Contrary to Petitioner's contention, a LVN lacks the medical training, skill, and authority to declare that a resident without a DNR order is not deserving of emergency care based on her judgment that he was ashen in color, cool to the touch, and without vital signs. As stated by RN Theresa Bennett, the Dallas Texas Regional Long Term Care Enforcement Coordinator, in her affidavit:
CMS Ex. 12, at 2. The treating physician could not abdicate his medical authority to a LVN based on information he received from her over the phone. I also find persuasive Ms. Bennett's opinion where she further states that:
CMS Ex. 12, at 2. In addition to the specific deficiency with respect to Resident #4, the facility placed the other residents at risk of suffering serious injury, harm, impairment or death resulting from the confused state of its DNR documentation practices. I, therefore, conclude that immediate jeopardy existed at Petitioner's facility on October 29, 2002. Furthermore, I conclude that Petitioner has not come forward with persuasive evidence or reasons to show that CMS's finding of immediate jeopardy is clearly erroneous.
CMS imposed a $5,000 per instance penalty for the deficiency regarding Notice of Rights and Services established by the State surveyors based on the October 30, 2002 survey. CMS may impose a CMP for either the number of days a facility is not in substantial compliance with one or more participation requirements or for each instance that a facility is not in substantial compliance, regardless of whether or not the deficiencies constitute immediate jeopardy. 42 C.F.R. § 488.430(a). In this case where Petitioner failed to provide emergency medical care to a resident notwithstanding the fact that the resident had not executed an out-of-hospital DNR, and also placed other residents at risk of serious injury, harm, impairment or death, a CMP of $5,000 is not unreasonable. Moreover, Petitioner has not disputed the reasonableness of the CMP. III. Conclusion I conclude that CMS correctly determined that on October 29, 2002, Petitioner was not complying with federal participation requirements in the Medicare and/or Medicaid programs at the immediate jeopardy level, and the imposition of a $5,000 CMP is reasonable. |
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| JUDGE | |
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José A. Anglada Administrative Law Judge |
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| FOOTNOTES | |
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1. To my surprise, neither party has offered the notice of imposition of remedies as an exhibit. I have, thus, entered that document inasmuch as I deem it of significance to have it in the record. 2. I found no documentary evidence in the record of the rescission of the remedies other than the CMP, but since the parties do not dispute it, I will accept it as true. 3. In this regard, it is important to distinguish between facts and conclusions. Conclusions and legal arguments do not establish material facts in dispute. 4. This assertion is consistent with CMS's statement that CPR should have been immediately started under the circumstances of this case. CMS's brief at 3. 5. Federal regulation provides that advance directives must conform to State law. 42 C.F.R. § 489.100. 6. Ms. Hudman stated in her affidavit that she immediately obtained the resident's chart, not that she immediately determined his DNR status. 7. In the affidavit at P. Ex. 2, executed on July 31, 2003, Ms. Hudman stated that after noting Resident #4's condition and that he had no vital signs, she immediately obtained the resident's chart and determined that he did not have a DNR. She added that because the Resident was obviously beyond the point of resuscitation, she then called the treating physician for further instructions. On October 29, 2002, however, Ms. Hudman indicated that after noting resident #4's condition she called for the CNA to examine the resident's chart in order to determine his DNR status. When none was found, she opted to call Dr. Keeling (the treating physician). CMS Ex. 5. This original statement is further at variance with the facility nurse's notes, where Ms. Hudman reported that upon finding Resident #4 with no vitals, she immediately called Dr. Keeling. Nothing was mentioned about retrieving the resident's chart to determine DNR status. CMS Ex. 6, at 2. It is worthy of note also that in her October 29, 2002 statement Ms. Hudman references discussions with the surveyors that could not have taken place until October 30, 2002. The inconsistencies noted here exemplify the facility's confusion regarding implementation of advance directives, and appears to explain why the facility created a DNR order after it had considered the resident to be deceased. See CMS Ex. 9. |
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