SUBJECT:

Barn Hill Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Barn Hill Care Center (Petitioner or Facility) is a nursing facility, located in New Jersey, that is certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare and Medicaid Services' (CMS) determinations that, from August 2, 1999 through August 11, 1999, it was not in substantial compliance with Medicare requirements, and that its deficiencies posed immediate jeopardy to resident health and safety. For the reasons set forth below, I conclude that from August 2, 1999 through August 11, 1999, the facility was out of compliance with the program participation requirements for Staff Treatment of Residents, Resident Assessment, Quality of Care, and Administration. The facility's deficiencies posed immediate jeopardy to resident health and safety, and the amount of the civil money penalty imposed - $5,000 per day for 10 days ($50,000 total) - is reasonable.

I. Background

On July 28, 1999, Petitioner's temporary employee, who did not have a valid New Jersey nursing license, administered overdoses of insulin to four facility residents. They became ill, and one was hospitalized. Stipulations 1, 2, 6, 7; see Discussion, infra. The facility reported the incident to the New Jersey Department of Health and Senior Services (State Agency), which conducted a complaint investigation survey at the facility on August 2, 1999. CMS Ex. 8. Following the survey, the State Agency concluded that the conditions at the facility posed immediate jeopardy to resident health and safety, citing four areas of deficiency: Staff Treatment of Residents, 42 C.F.R. § 483.13 (Tag 224); Resident Assessment, 42 C.F.R. § 483.20 (Tag 281); Quality of Care, 42 C.F.R. § 483.25 (Tag 333); and Administration, 42 C.F.R.§ 483.75 (Tag 499). CMS Exs. 3, 4, and 5.

CMS reviewed the state findings and, by letter dated August 13, 1999, advised the facility that its conditions constituted immediate jeopardy to resident health and safety, and, therefore, its provider agreement would be terminated on August 25, 1999, if the immediate jeopardy were not removed. CMS also imposed a denial of payment for new admissions, effective August 21, 1999, and a Civil Money Penalty (CMP) of $5,000 per day, effective August 2, 1999, to remain in effect until the facility achieved substantial compliance with program requirements or was terminated. CMS Ex. 2.

The facility submitted a plan of correction, dated August 6, 1999, and, following a revisit survey on August 12, 1999, the State Agency concluded that the facility had achieved substantial compliance. CMS Ex. 6. CMS reviewed the state findings, and, by letter dated September 24, 1999, advised the facility that because it had achieved substantial compliance, CMS was rescinding the denial of payment for new admissions. However, CMS was imposing the $5,000 per day CMP, from August 2, 1999 through August 11, 1999, for a total of $50,000, and the facility was prohibited from conducting its own nurse aide training and competency evaluation for a period of two years. CMS Ex. 1. Petitioner timely requested a hearing.

A hearing was held before me on July 24, 2001, in Trenton, New Jersey. Mr. Joseph L. Bianculli appeared on behalf of Petitioner, and Mr. David A. Rawson appeared on behalf of CMS. CMS Exhibits (Exs.) 1 through 15 and Petitioner's Exhibits (P. Exs.) 1 through 44 were admitted into evidence.

II. Issues

1. Whether, from August 2, 1999 through August 11, 1999, the facility was in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.13 (Staff Treatment of Residents), 42 C.F.R. § 483.20 (Resident Assessment), 42 C.F.R § 483.25 (Quality of Care) and 42 C.F.R. § 483.75 (Administration).

2. If the facility was not in substantial compliance, did its conditions pose immediate jeopardy to resident health and safety?

3. If the facility was not in substantial compliance, is the amount of the Civil Money Penalty imposed, $5,000 per day, reasonable?

III. Statutory and regulatory background

The Social Security Act (Act) sets forth requirements for nursing facility participation 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 nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare program, a nursing 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. A facility's noncompliance constitutes immediate jeopardy if it has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." Id. Immediate jeopardy can exist regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998).

Under the statute and the "quality of care" regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity. The assessment must be comprehensive, accurate, standardized, and reproducible. 42 C.F.R. §§ 483.20, 483.25.

The facility is required to make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. The services provided must meet professional standards of quality and be provided by qualified persons. 42 C.F.R. § 483.20(k)(3). Also, as part of the quality of care requirements, the facility must insure that residents are free of any significant medication errors. 42 C.F.R. § 483.25(m)(2).

Similarly, under the "administration" requirement, the facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psycho-social well-being of each resident. 42 C.F.R. §483.75. Specifically, the facility must employ, on a full-time, part-time, or consultant basis, those professionals necessary to carry out the regulatory requirements. Professional staff must be licensed, certified, or registered in accordance with applicable State laws. 42 C.F.R. § 483.75(g).

With respect to staff treatment of residents, the facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property. 42 C.F.R. § 483.13(c).

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 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.

In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for causing more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 per instance. CMS increases the per day penalty amount for any repeated deficiencies for which a lower level penalty amount was previously imposed. 42 C.F.R. § 488.438.

In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The section 488.404 factors include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

IV. Burden of proof

The facility must prove, by a preponderance of evidence, substantial compliance with program participation requirements, once CMS has established a prima facie case that the facility was not in substantial compliance. Emerald Oaks, DAB No. 1800, at 4 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999).

V. Findings of fact, conclusions of law and discussion

In reviewing CMS' determination here, I must answer two questions:

1) Was the facility in substantial compliance with the cited regulatory provisions? CMS must present a prima facie case with evidence that, if credible and unrebutted, would constitute proof that the facility was not in substantial compliance. The facility then has the ultimate burden of showing, by a preponderance of the evidence, its substantial compliance with each cited provision. Koester Pavilion, DAB No. 1750 (2000).

2) If I conclude that the facility was not in substantial compliance, I next consider whether the level of non-compliance posed immediate jeopardy to resident health and safety. CMS' determination as to immediate jeopardy must be upheld unless clearly erroneous, 42 C.F.R. § 498.60(c)(2), and the level of noncompliance is subject to review only if a successful challenge would affect the range of the CMP amounts that CMS could impose.

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

1. From August 2, 1999 through August 11, 1999, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. §§ 483.13 (Staff Treatment of Residents), 483.20 (Resident Assessment), 483.25 (Quality of Care) and 483.75 (Administration).

The parties may quarrel about the inferences to be drawn from them, but the basic and dispositive facts in this case are not in dispute. Petitioner employed temporarily Dawn Keady as a licensed practical nurse (LPN). Stipulation 1. Nurse Keady did not have a valid New Jersey LPN license. Stipulation 2; Tr.at 38 . She worked in the facility six times without producing evidence of her license. On July 28, 1999, she was assigned to the Newtonian Unit of the facility, where four insulin-dependent diabetic individuals resided. That morning, she used the wrong type of syringes to administer insulin, and, as a result, administered overdoses of insulin to the four diabetic residents. Stipulations 3 - 6. At least three of the four experienced adverse effects. Stipulation 7. Shortly after receiving her overdose of insulin, Resident 3 ⁽¹⁾ became acutely ill and went into respiratory distress, which Nurse Keady observed. Nurse Keady called the resident's treating physician, but Resident 3 was essentially left untreated from 9:00 AM until 11:30 AM when staff happened upon her, near death. ⁽²⁾

a. The facility employed an unlicensed and unqualified nurse whose services did not meet professional standards of quality.

That Nurse Keady was unlicensed in New Jersey, and Petitioner should not have allowed her to work as an LPN is beyond dispute. ⁽³⁾ Allowing an unlicensed person to pass medications plainly violates federal requirements. See 42 C.F.R. §§ 483.20(k)(3); 483.75(b), (g), and (h). Nor was this a one-time aberration. From July 2 through July 28, 1999, Nurse Keady worked as an LPN at the facility six times (Tr.at 75) without demonstrating that she was licensed. Tr.at 41. Petitioner apparently only learned that she was not licensed after the fact, during its investigation into the insulin overdoses. CMS Ex. 10.

Petitioner admits the deficiency, but downplays its significance, characterizing its error as simply "allowing someone to work without producing a license." Citing only to its own witness' testimony, Petitioner claims "no dispute that Keady's licensure status was immaterial to the errors she made." P. Brief at 30. I find the opposite to be true; in fact, Nurse Keady's licensure status is inextricably intertwined with her performance, and the fact that she was unlicensed is cited throughout the statement of deficiencies in discussing the deficiencies that posed immediate jeopardy to resident health and safety. Under 42 C.F.R. § 483.13 (staff treatment of residents), CMS states: "The insulin was provided by an LPN who is not licensed in the State of New Jersey." Under § 483.20 (Resident Assessment), the statement reiterates "The LPN . . . who had no license to practice, administered Insulin . . . ." CMS Ex. 3, at 3; emphasis added.

This was not a situation in which a licensed employee simply failed to produce evidence of licensure, but otherwise comported herself in an exemplary manner. Nurse Keady did not produce a license because she did not have one; she was unqualified to perform the duties assigned; and her inadequacy had consequences, all factors that remove this deficiency from the merely technical category. Nor is it surprising that this unlicensed nurse's performance did not otherwise meet professional standards of quality, since a relationship exists between licensing and competence. Licensing protects the public from incompetent practitioners. As a matter of law, an unlicensed nurse is not qualified to provide professional nursing services, and may not administer medications. And this case well illustrates the logic of that requirement.

Nor am I persuaded that Nurse Keady's New York license somehow excuses Petitioner's error in allowing her to work. The New Jersey facility's allowing her to provide services without requiring that she could legally do so in New Jersey per se violates the regulations. 42 C.F.R. §§ 483.20(k)(3); 483.75(g). To hold otherwise would absolve parties from compliance with state law, which I am not authorized to do. Besides, Petitioner has not claimed that Nurse Keady was otherwise competent, and admits that her performance was abysmal.

As the uncontroverted evidence shows, the absence of a valid license was only part of the problem. Not only was Nurse Keady legally unqualified to perform LPN duties, she was not capable of performing those duties, and the fact that she may have held a license from another state did not make her qualified -- either legally or otherwise -- to work as a nurse at the facility. ⁽⁴⁾ From her first day, staff questioned whether she was up to the job. In unchallenged testimony, Surveyor Bennett recounted her conversation with Nurse Witt, a registered nurse who was the facility's development and in-service coordinator. Nurse Witt was responsible for orienting new employees, including Nurse Keady, to the facility. She told the surveyor that Nurse Keady was new to the profession, having worked for her agency as a home health aide until June 1, 1999, when she changed her status to LPN. Tr. at 41. She described Nurse Keady as "overwhelmed" by the demands of the job, complaining on her first day that the medication pass was heavy. Tr.at 42. Even though it was her first day, and even though she complained, no one assisted her or observed her performing the medication pass. Tr. at 44.

Nurse Keady next returned to work at the facility on July 6. After she left that day, staff noted blanks on the medication administration record where she failed to sign, which suggests that the ordered medication had not been given. When staff called the agency to inquire, Nurse Keady claimed that she had given all medications, but simply failed to sign the record as required. Surveyor Bennet, who is herself a registered nurse, explained that such failure to sign presents dangers because it indicates that the medication was not given, which could prompt someone else to administer the medication a second time. Tr. at 44 - 45. ⁽⁵⁾ The record is virtually silent as to Nurse Keady's performance on the three subsequent days she worked at the facility. She was not assigned to the Newtonian Unit on those days, but the record does not reflect the nature of her assignment, the demands placed on her, nor the quality of her performance. ⁽⁶⁾

Although Petitioner willingly concedes Nurse Keady's inadequacies, it admits little direct culpability in having allowed her to work. Petitioner excuses itself by placing the blame instead on the agency that supplied Nurse Keady, arguing that the facility justifiably relied on that agency to provide qualified nurses. Becky Mengel, who works for Petitioner's corporate offices as Director of Clinical Services for part of the mid-Atlantic region in Pennsylvania, testified that she expects any agency nurse to be able to perform independently. Tr. at 141, 155. The regulations, however, place responsibility for the adequacy of staff squarely on the facility and do not allow it to transfer that responsibility to an outside entity:

Arrangements as described in section 1861(w) of the Act or agreements pertaining to services furnished by outside resources must specify in writing that the facility assumes responsibility for--

(i) Obtaining services that meet professional standards and principles that apply to professionals providing services in such a facility . . . .

42 C.F. R. § 483.75(h)(2) (emphasis added). I note that, consistent with this requirement, Petitioner's agreement is silent as to the staffing agency's responsibility for the adequacy of its staff, but holds the facility responsible for orientation and supervision of personnel "while the personnel are performing services." P. Ex. 44, at 2. Further, the agreement effectively incorporates the provisions of the regulation. Id. at 3. ("[A]ny provision . . . deemed to be in violation of any Federal or State law or regulation governing the subject matter of this agreement . . . shall be amended in accordance with said law or regulation.") Petitioner was thus accountable for the performance of all facility staff, including the agency nurses.

Petitioner also suggests that it should not be held accountable for problems that stem from "human error," rather than from any systemic weakness in the facility's administration. Tr. at 143. Conceding that it is not appropriate for a nurse who is unlicensed in New Jersey to be passing medications in a New Jersey facility, and that the facility repeatedly allowed Nurse Keady to perform duties that can only be performed by a licensed nurse, Director Mengel nevertheless insisted that the facility processes were sufficient, placing the blame on facility staff:

I think it was an error on the person who was responsible to check the license . . . the staffing coordinator. It was the staffing and scheduling coordinator.

Tr. at 156 - 157.

I am not aware of any "human error" exception to the regulatory requirements. Indeed, it is difficult to imagine any deficiency that is not, at its core, attributable to "human error." A facility, therefore, puts in place systems that minimize the chance for human error. Here, notwithstanding Petitioner's protestations, this facility simply did not have the necessary systems in place to protect its residents from unlicensed and unqualified staff. Director Mengel claimed that she reviewed the facility policies and procedures, including the orientation for agency nurses and the license verification process, and that she found nothing inadequate. Tr. at 136. However, when asked whether the facility had submitted such documents as exhibits, she subsequently admitted that those policies or procedures were not "reduced to writing," but were "processes that were in place at the center." Tr. at 138. Petitioner's performance demonstrates that it lacked adequate safeguards to ensure that only licensed and qualified persons provided the necessary professional services, in contravention of 42 C.F.R §§ 483.25 (quality of care), and 483.75 (administration). See Emerald Oaks, DAB No. 1800, at 7 n.3 (2001)(discussed supra).

b. The facility did not insure that its residents were free of significant medication errors.

That significant medication errors occurred is undisputed. Not only were four residents given dangerous overdoses of insulin, but for one-third of the residents on the Newtonian Unit, medications were not timely administered according to acceptable standards of practice.

In uncontroverted testimony, Surveyor Bennett explained that standards of practice require that medications be administered within one hour of the time ordered. So, the 9:00 AM medication pass could begin as early as 8:00 AM, and should be completed by 10:00 AM. Nurse Keady, however, was not able to finish administering the medications within a reasonable time. By 11:30 AM, she had still not administered the ordered medications to 10 of 29 residents. CMS Ex. 3 at 3. Indeed, according to Nurse Witt, who was eventually assigned to help with the 9:00 AM medication pass, she and Nurse Keady did not complete the task until 2:00 PM. CMS Ex. 15 at 4. Contrary to Petitioner's claim that "CMS offered no evidence that any resident actually was injured by Nurse Keady's delay," (P. Brief at 7), the record suggests that at least one resident desperately needed her 9:00 AM medication.

Resident 3 was among those who had not received their 9:00 AM medication by 11:30 AM. She suffered from congestive heart failure and was on oxygen. Her routine 9:00 AM medications included Prednisone, Theodur, and a Nebulizer treatment, which are intended to alleviate respiratory problems. Tr. at 50 . At 9:00 AM, Nurse Keady noted that Resident 3 was weak and had difficulty breathing, so that she subsequently called Resident 3's attending physician to advise him of the respiratory distress; yet, she did not administer the medication that had been ordered to alleviate Resident 3's respiratory symptoms.

Failure to administer medication timely was not the only significant medication error of the morning. Insulin is routinely administered at the start of the morning medication pass because those dependent on insulin need to have it before breakfast. Tr. at 154. Between 7:30 AM and 8:00 AM on the morning of July 28, 1999, Nurse Keady, apparently using the wrong type of syringes, administered overdoses of insulin to the four insulin-dependent residents on the Newtonian Unit who suffered significant, adverse reactions. CMS Exs. 3, at 3, 13 at 7; P. Exs. 2, 3. Resident 1 ⁽⁷⁾ was found unresponsive and foaming at the mouth at 12:45 PM. P. Ex. 8, at 2. A blood sugar finger stick did not register on the glucometer because her level was too low. P. Ex. 8 at 2. At 1:00 PM, her level was 34. IV Dextrose was administered and at 1:45 PM her blood sugar was 83. CMS Ex. 3, at 4; P. Exs. 21, 22, 23, 24. According to a facility statement, Resident 1 also exhibited signs of low blood sugar on the 3:00 - 11:00 PM shift. P. Exs. 2, 8, at 2.

Resident 2 ⁽⁸⁾ was found slumped in her chair sometime between noon and 12:30 PM. Her blood sugar was 31. She was treated, and at 5:00 PM, her blood sugar was 38. CMS Ex. 3, at 5; P. Ex. 8, at 2; P. Ex 10; see P. Ex. 2.

Resident 3 was admitted to the hospital with profound hypoglycemia, among other diagnoses. P. Ex. 16.

Resident 4 ⁽⁹⁾ was found unresponsive in bed at 5:00 PM, with a large skin tear on her right arm caused by a fall against a door. Her blood sugar was 40. She was given orange juice and sugar, and then dinner. P. Exs. 9, 34. At 7:00 PM her blood sugar was 66. P. Ex. 34.

Thus, the facility failed to administer medications according to accepted standards of practice. It did not insure that residents were free of significant medication errors.

Further, residents were not provided care and services in accordance with physician's orders, assessments, and medication orders. On this basis, CMS appropriately determined that the facility did not meet regulatory requirements under 42 C.F.R. §§ 483.25 (quality of care) and 483.20 (resident assessment), and that its failures constituted substantial noncompliance.

c. The facility failed to implement policies and procedures that prohibited the neglect of its residents.

CMS also concluded that, in contravention of 42 C.F.R. § 483.13(c), the facility had not developed and implemented written policies and procedures that prohibited the neglect of its residents. In addressing this issue, I consider whether the facility actions (or inaction) constituted neglect, and, if so, whether such neglect constitutes a deficiency under 42 C.F.R. § 483.13(c). ⁽¹⁰⁾

1) The facility's residents were neglected.

Neglect means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. 42 C.F.R. § 488.301. Based on 1) the facility's failure to administer, within acceptable time parameters, medications to 10 residents out of 29; 2) the administration of insulin overdoses to 4 residents; and 3) the facility's treatment of Resident 3 when she became acutely ill on the morning of July 28, CMS concluded that the facility had not prevented the neglect of its residents. CMS Ex. 3, at 1-3. About the timeliness of the drug administration, and the insulin overdoses, there is no serious factual dispute. Petitioner seems to overlook those two bases for CMS' neglect finding, confining its argument to the treatment provided to Resident 3 when she became acutely ill. However, the failures and errors in the administration of medication also constitute neglect.

In considering the treatment (or lack of treatment) provided to Resident 3, I note first that, in defending its practices, Petitioner did not call as witnesses any staff who were working in the facility at the time, who might have had first hand knowledge of the care provided. Throughout the record are references to staff, in addition to Nurse Keady, who were present in the Newtonian Unit throughout the day. See P. Exs. 8, 9, 10, 21. However, instead of calling them, Petitioner submitted documentation, mostly staff statements generated after the fact, that is inconsistent, incomplete, confusing, and, in some instances, illegible. Petitioner then goes through the staff statements and through Resident 3's sketchy medical record, drawing inferences in the light most favorable to the facility, sometimes in very unreasonable, even fanciful, ways.

The record establishes that Resident 3 was seriously ill. Among other ailments, she had a significant history of chronic obstructive pulmonary disease (COPD), congestive heart failure, and insulin dependent diabetes. P. Ex. 16. In addition to insulin, her medication orders included Lasix, Theodur, Prednisone, and a nebulizer treatment, to be administered at 9:00 AM. According to July 28 treatment notes, at 6:00 AM, staff observed "some effort needed to breathe," although the resident claimed that it was "no harder than normal." The nurse then noted that she would "continue to observe." P. Ex. 13, at 2. The record does not reflect whether this information was conveyed to Nurse Keady or to anyone else at the 7:00 AM staff change. In their statements, no staff member suggests that she had advance notice that Resident 3 had been experiencing breathing problems.

9:00 AM and 11:30 AM. The absence of any recorded observations does not support the claim that staff were keeping the resident under close observation. See Emerald Oaks at 24.

Sometime after 9:00 AM, Nurse Keady called Resident 3's primary care physician, Dr. Grote, who subsequently ordered a complete blood count (CBC), chest x-ray, and sputum culture, and an IM injection of Rocephen, an antibiotic, to be administered after the blood culture. Nurse Keady's July 29 statement indicates that Dr. Grote called in his orders at 10:00 AM (P. Ex. 8), although the physician order sheet indicates that he called in at 10:30 AM. P. Ex. 14.

Based on the muddled record before me, it is difficult to determine the timing of the events of July 28. However, this much is plain: the record contains no reliable evidence that staff adequately monitored Resident 3's condition, or provided her with care (not even her routine respiratory medications) from at least the time of Nurse Keady's observation at 8:00 or 9:00 AM until sometime after 11:30 AM, when Nurse Witt found her unresponsive, in acute respiratory distress. Tr. at 50, 65; P. Ex. 13, at 2.

Petitioner submits only a partial treatment record for Resident 3, which consists of three pages, with some pages obviously missing. Page one of the document includes notes from July 22 through 27, 1999, which are of limited relevance to this case. Page two contains additional treatment notes for July 27, and notes for July 28, including Nurse Keady's notes, which on their face, appear to have been written at 8:00 AM, 9:00 AM, noon, and 1:00 PM, although Petitioner maintains, and I have no reason to doubt, that Nurse Keady drafted them all at the same time, after the fact. P. Ex. 13 at 2. A third page of treatment notes, obviously written by someone other than Nurse Keady, follows. The page begins mid-sentence, with the notation "Nsg. cont." This first partial entry describes Resident 3's breathing (respirations 50 shallow, labored) but does not indicate the time of that observation, information likely contained on a page that Petitioner did not submit. ⁽¹²⁾

Looking to the other evidence, a statement from LPN Sandy Osborne describes a conversation she had with Nurse Keady "after lunch trays were delivered to Newtonian Hall," ⁽¹³⁾ when she brought to Nurse Keady's attention the crisis with Resident 2. "Dawn said 'I cant [sic] handle this. I have to give [Resident 3] this Rocephen.'" P. Ex. 10. Nurse Osborne relates that she herself immediately attended to Resident 2, which, according to Resident 2's treatment records, occurred at noon. P. Ex. 28. Nurse Osborne subsequently called DON Callahan to tell her that Nurse Keady needed help "because she couldn't handle the hall between dealing with [Resident 3] and what was happening with [Resident 2]." Id. This suggests that, by as late as noon the Rocephen had not been administered, and that Nurse Osborne contacted DON Callahan at about noon. After making the call, Nurse Osborne relates that she performed Accuchecks on another unit, and returned to check on Resident 2, and then went to report to Nurse Keady, who asked for help in administering the Rocephen. After demonstrating how to draw up the Rocephen, Nurse Osborne returned to her desk, but approximately two minutes later, the aides called her to go to room 20, where she found Resident 1 "frothing from the mouth and unresponsive." P. Ex. 10. According to Resident 1's treatment records, this occurred at 12:45 PM. P. Ex. 21, 24. Then, as Nurse Osborne was going to her desk, Nurse Witt came on the hall, which suggests that Nurse Witt appeared on the scene some time after 12:45. P. Ex. 10. ⁽¹⁴⁾

On the other hand, in her statement, the Director of Nursing, Denise Callahan RN, says that she first learned of a potential problem at 11:30 AM when Nurse Osborne told her that Nurse Keady needed help with the medication pass. She sent Nurse Witt to assist. According to Nurse Callahan, at about 11:45 AM, Nurse Witt called, asking her to check Resident 3 to see if she needed to be sent to the hospital. Nurse Callahan found Resident 3 "unresponsive, face flushed, diaphaetic [sic?], with respirations rapid," and instructed Nurse Witt to transfer her immediately. P. Ex. 9.

According to Nurse Witt's statement, at 11:30 AM, DON Callahan asked her to assist with the morning medication pass because Nurse Keady was having difficulty administering medications on a timely basis. CMS Ex. 15. Resident 3 had not received her 9:00 AM medications and Nurse Witt found her in respiratory distress, with fluctuating consciousness, unresponsive to verbal stimuli. Nurse Witt took her vital signs, gave her the 9:00 AM nebulizer treatment, and increased her oxygen. She called Nurse Keady who told her that she had called the doctor at 9:30 and received orders at 10:30 AM for stat lab work, chest x-rays, and Rocephen, which she claimed she had given. At about 11:45 AM, according to Nurse Witt's statement, she saw Dr. Casella and asked him to check Resident 3, while she called the attending physician. At the same time, Resident 1 was found unconscious, her blood sugar level not registering, ⁽¹⁵⁾ and Resident 2 was having symptoms of low blood sugar. Dr. Casella gave orders for Lasix and "to insert a heparin loc." Nurse Witt administered the IM Lasix, and Dr. Casella told her to arrange for transportation to the emergency room. According to Nurse Witt, Resident 3 was transferred at 12:45. CMS Ex. 15, at 1 - 3.

Other records indicate that staff placed a call to Dr. Grote for an order to transport Resident 3 to the emergency room. While the call was being placed, Dr. Casella, a facility doctor, arrived and was directed to the resident room to assess her condition. He described her as "critical, death probable." P. Ex. 14. He wrote orders for an injection of Lasix, for oxygen, for IV Lasix, and for an IM injection of Decadron stat (to be administered immediately). Tr. at 53. According to the transfer form, the IM Lasix was administered at 12:30 PM. P. Ex. 15. Neither the IV Lasix, nor the IM Decadron were provided. In an addendum to her statement, Nurse Witt indicates that she had not inserted the "hep-loc" because of the decision to transport Resident 3 to the hospital, and that she was not aware of the written orders for IV Lasix and Decadron. CMS Ex. 15 at 8. The physician's order to transfer indicates that it was received at 12:55 PM, but the record does not reliably establish the time Resident 3 was transferred. Assuming the transfer order is correct (P. Ex. 14), Nurse Witt's assertion that Resident 3 was transferred at 12:45 PM is likely incorrect.

Resident 3 arrived at the hospital with a blood sugar level of 19 and was diagnosed with profound hypoglycemia and exacerbation of congestive heart failure. CMS Ex. 3, at 3; P. Ex. 16. She nevertheless survived and returned to the facility, a readmission note indicating, among other diagnoses, "insulin induced diabetic coma." P. Ex. 13, at 3.

Contrary to Petitioner's suggestions, the statements from Nurses Keady and Witt were not taken independently. See P. Brief at 11. According to Administrator Brown's statement, on July 29, the same day they wrote their statements, the three met and discussed the events of July 28. P. Ex. 7; see CMS Ex. 15, at 6. The record is silent as to whether DON Callahan or Nurse Osborne discussed with anyone the events of the day prior to writing their statements. So, on the one hand, we have the time sequence suggested by Nurse Osborne's statement and the treatment notes of Residents 1 and 2, which are not inconsistent with the physician's order sheet; on the other hand, we have the time table suggested by Nurses Keady, Callahan, and Witt. Inasmuch as Nurses Keady and Witt discussed the incidents before preparing their statements, I do not find them inherently more reliable than Nurse Osborne's and the treatment records. Petitioner also claims, based on the thinnest of evidence, that between 9:00 AM and 11:30 AM someone drew Resident 3's blood. CMS challenges the reasonableness of that inference. However, I need not resolve these conflicts since, under all scenarios, staff did not give Resident 3 her 9:00 AM medications, did not follow Dr. Casella's orders for IV Lasix and Decadron, and allowed her condition to deteriorate to the point of "critical, death probable" before considering a life-saving transfer to a hospital. In addition, CMS has demonstrated that the facility failed to administer, within acceptable time parameters, medications to 9 other residents and that it administered insulin overdoses to 4 residents. Such failures constitute neglect. ⁽¹⁶⁾ I next consider whether these findings of neglect constitute a deficiency under 42 C.F.R. § 483.13(c).

2) The facility was out of compliance with 42 CFR §483.13(c).

42 C.F.R. § 483.13(c) requires that the facility develop and implement written policies and procedures prohibiting resident neglect. It "addresses a deficiency related to lack of an effective policy as opposed to one directed at the occurrence of neglect itself." Emerald Oaks at 17. Petitioner criticizes what it characterizes as CMS' "expansive" reading and application of the regulation to this case:

[W]hile Nurse Keady may not have been doing a very good job, she was at least trying to provide appropriate services to the residents under her care, including Resident 3. There is no indication in the text of Section 483.13(c) or its context that the regulation was intended to control - or even apply to - analysis of the adequacy or quality of the care actually provided to a resident, much less to provide an independent basis to impose regulatory liability against a nursing facility for caregiver errors which - as here - can be and are cited under more specific regulatory provisions.

P. Brief at 22 - 23. That Nurse Keady may have been "trying" to provide appropriate services hardly furthers Petitioner's case. In fact, it suggests that her numerous errors were attributable to the facility's systemic failure to provide the kind of support and training she needed to perform her job adequately. As the appellate panel pointed out in Emerald Oaks, responsibility for the neglect of a resident, and for implementation of a policy to forestall such neglect, does not stem solely from the actions of a single nurse. The Board there specifically rejected a facility's similar effort to evade its own responsibility by placing blame on the unquestionably inadequate performance of one employee. There, the facility claimed that its deficiencies stemmed from the actions of one nurse, who had not been trained properly and who acted "so far outside her duties that she lost her license." Id. at 7. Rejecting this notion, the Board pointed out that the nurse was acting within the scope of her employment responsibilities, which were to provide care for the residents.

Her employer cannot disown the consequences of the inadequacy of the care provided by the simple expedient of pointing the finger at her fault, since she was the agent of her employer empowered to make and carry out daily care decisions.

Id. at 7 n.3.

Nor do I find any support in the text of the regulation or elsewhere for the proposition that deficiencies cited under the quality of care or other regulation may not also constitute deficiencies under 42 C.F.R. § 483.13(c). Just the opposite is true: if the facility has not implemented a policy to prevent neglect, and its residents are neglected, it is unlikely that they have been provided care and services sufficient to attain or maintain the "highest practicable physical, mental, and psychosocial well-being." One would therefore expect to see deficiencies cited under other regulations in addition to section 483.13. As here, the question might be academic since those deficiencies cited under other regulations could well sustain the penalties imposed. However, that fact does not mean that the facility satisfies the requirements of section 483.13.

There has been little appellate discussion of § 483.13. The Emerald Oaks panel considered the issue before them one of first impression. There, CMS cited the facility under § 483.13 because one resident was not adequately monitored to prevent injury, and his physician was not notified of significant changes in his condition. Petitioner made arguments similar to those raised by Petitioner in this case: that the regulation does not prohibit neglect per se, but addresses a requirement to develop and implement a policy, and that a finding of neglect cannot be supported by taking isolated events out of context. The Board noted that implementing policies "clearly means something more than maintaining a paper file of documents without actually regulating staff actions," and found that the ALJ made no error of law in drawing the inference that "sufficient examples of neglect can demonstrate lack of implementation of an anti-neglect policy." Emerald Oaks at 18.

As set forth above, the deficiencies here go beyond "isolated events taken out of context." CMS has demonstrated significant instances of neglect, involving multiple residents. Reasonably interpreted, those facts evidence Petitioner's failure to implement an effective anti-neglect policy. Petitioner offered virtually no evidence, and certainly no reliable evidence, showing what systems it had in place to prevent neglect. It did not point to evidence of written policies nor explain how such policies were implemented, the same types of evidentiary shortcomings criticized by the Emerald Oaks panel when it affirmed the ALJ finding of substantial noncompliance with § 483.13(c). Id.

Thus, CMS has met its burden of setting forth a prima facie case that Petitioner failed to implement anti-neglect policies. Petitioner has not come forward with evidence to refute that case. ⁽¹⁷⁾ I therefore conclude that the facility was out of compliance with 42 C.F.R. § 483.13(c).

2. Petitioner's level of noncompliance posed immediate jeopardy to resident health and safety.

I next consider whether CMS' immediate jeopardy finding is "clearly erroneous." 42 C.F.R. § 498.60(c)(2). Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. As noted above, immediate jeopardy can exist regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998).

Although Petitioner makes some attempt to minimize the seriousness of the harm caused by the overdoses ("no evidence that the resident's respiratory problems were caused or exacerbated by her insulin overdose and subsequent hypoglycemia" P. Brief at 15), it is pointless to argue that the significant nursing errors described above did not cause the affected residents serious harm, and did not have the potential for causing even greater harm. ⁽¹⁸⁾ Among other injuries, the residents suffered significant adverse reactions to the insulin overdoses. Resident 1 was found unresponsive and foaming at the mouth. Resident 2 was found slumped in her chair with blood sugar level of 31. Resident 3 was admitted to the hospital, with profound hypoglycemia. Resident 4 was found unresponsive in bed with a large skin tear caused by a fall against a door. Moreover, a finding of immediate jeopardy is not contingent on a finding of actual harm, but encompasses situations where there is a likelihood of serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001). Failure to administer medications as prescribed, along with the other nursing deficiencies, unquestionably creates the likelihood of serious harm. Thus, inasmuch as the facility's deficiencies caused actual harm, and had the potential to cause even more serious harm, I do not consider erroneous CMS' finding of immediate jeopardy.

3. The duration of the CMP is consistent with statutory and regulatory requirements.

Petitioner concedes that one of its staff members, who was not licensed , "made significant professional errors that caused injury to as many as four residents on July 28, 1999," but characterizes the problem as a "single error or series of errors by a single nurse on a single occasion." From this, Petitioner argues that, since the deficiencies revolved around the errors of one employee who did not return to the facility after July 28, CMS may not find noncompliance at the time of the survey (August 2, 1999) and should not have imposed a CMP for that day nor any of the 10 subsequent days. ⁽¹⁹⁾ I do not accept the proposition that CMS' failure to impose the penalty at the earlier time precluded it from imposing any remedy at all.

Common sense indicates that no nursing facility uses agency staff by choice: they are expensive, unreliable, and, by definition, less familiar with a facility's residents and routines than are full-time staff.

P. Reply Brief at 14 n.9. For this reason, if using an agency nurse, the facility needs adequate systems in place to monitor qualifications, and to provide orientation and supervision. None of these systems were in place on July 28, and the facility has not demonstrated adequate correction prior to August 12. See Fairfax Nursing Home, Inc., DAB No. 1794, at 19 (2001). (Adopting a protocol without taking sufficient steps that it will be followed is inadequate to meet the regulatory requirement that the facility ensure that residents attain and maintain the highest practicable physical well-being).

Moreover, under the regulatory scheme, any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility that need to be corrected. Lake City Extended Care Center, DAB No. 1658, at 14 (1998). Since I found that the incidents in question have the potential for more than minimal harm, I must also find that the facility was out of compliance "from the date of the completion of the survey in which this incident was cited until the date of the resurvey in which substantial compliance was established." Emphasis added; id. at 14 - 15. Substantial compliance means not only that the surveyors found no other incidents, but also that the facility has implemented a plan of correction designed to assure that no such incidents occur in the future. No findings that the facility violated the standard of care between these dates are required in order to find the facility out of substantial compliance, nor can evidence of other incidents in which the facility met the standard of care change the fact that it was out of substantial compliance. Lake City, at 15. See also Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002) ( The burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that the deficiencies continued to exist after they were discovered.); Asbury Center at Johnson City, DAB No. 1815, at 19 - 20 (2002) ("[A] facility's return to substantial compliance must usually be established through a resurvey, and in a situation involving inadequate supervision, requiring such a resurvey seems wise."); Cross Creek Health Care Center, DAB No. 1665 (1998).

I therefore conclude that because the facility had not implemented a plan of correction designed to assure that no such incidents occur in the future, CMS appropriately found it out of substantial compliance at the time of the survey and thereafter.

4. The amount of the CMP imposed, $5,000 per day, is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. § 488.438(f). Emerald Oaks at 10; CarePlex of Silver Spring, DAB No. 1683, at 13 - 17 (1999). In its main brief, Petitioner argues that I lack the authority to make such finding "de novo" where CMS has not offered evidence that it considered those regulatory factors. Petitioner suggests that not assessing the manner in which CMS applied the § 488.438 criteria means that CMS has "unbridled discretion to impose any CMP (i.e. seize any amount of the nursing facility's property) it chooses, rendering 42 C.F.R. § 488.438(f) a nullity." P. Brief at 34. Petitioner acknowledges the ALJ's contrary decision in Emerald Oaks, DAB CR801 (July 26, 2001), but asserts that the judge "fundamentally misread" the Medicare statute and DAB precedent.

Petitioner's position was fully addressed and rejected by the appellate panel in Emerald Oaks. Citing a line of cases, the Board there reaffirmed its rejection of the notion that the ALJ must review CMS' internal process in setting a CMP amount. Emerald Oaks at 11; see also Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No.1629 (1997); South Valley Health Care Center, DAB No. 1691 (1999) .

[C]ontrary to Emerald Oaks' position, the purpose of the hearing here was not to determine whether CMS followed the correct procedure in determining to impose a CMP or setting the amount of the CMP. The hearing at the ALJ level in such cases is intended to determine two fundamental questions: (1) whether a basis existed to support the imposition of the CMP under governing statutory and regulatory authorities, and (2) whether the amount of the CMP fell within a reasonable range based on the applicable law. The ALJ resolves these issues de novo in the sense that the determination is based on the evidence as it is developed before the ALJ and not on how CMS evaluated the evidence as it stood at whatever point CMS made its assessment.

Emerald Oaks at 13.

So, in reaching a decision on the reasonableness of the CMP, I may not look into CMS' internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS' factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS' discretion. Community Nursing Home, DAB No. 1807, at 22, et seq. (2002); CarePlex, DAB No. 1638, at 8.

CMS imposed a penalty of $5,000, which is at the lower end of the mandatory range ($3,050 to $10,000) for immediate jeopardy situations. With respect to the § 488.438(f) factors, the record is silent as to the facility's compliance history and financial condition. However, the seriousness of the deficiencies and the facility culpability justify the imposition of a penalty above the minimum, and I am, therefore, not able to find CMS' determination unreasonable.

CONCLUSION

For the reasons discussed above, I uphold CMS' determination that from August 2, 1999, through August 11, 1999, the facility was not in substantial compliance with program participation requirements for Staff Treatment of Residents, Resident Assessment, Quality of Care, and Administration. The facility's deficiencies posed immediate jeopardy to resident health and safety, and the amount of the civil money penalty imposed - $5,000 per day for 10 days ($50,000 total) - is reasonable.

Carolyn Cozad Hughes

Administrative Law Judge

1. Resident 3 is sometimes referred to as C.J. See P. Ex. 1.

2. The parties disagree as to whether and to what degree Nurse Keady monitored Resident 3's condition; however, as discussed below, no reliable evidence in the record indicates that she or any other staff provided adequate treatment until after 11:30 AM.

3. Petitioner, without citation to the record, asserts certain peripheral "facts" regarding Nurse Keady's background and experience that are simply not supported. Aside from the limited hearsay information supplied by Surveyor Bennett (whose trainee spoke to someone from the employment agency), the record says little about Nurse Keady's actual qualifications or how she was authorized to practice as an LPN in New York. Tr. at 77. The evidence in this record establishes only that Petitioner regularly employed temporary staff, which it obtained from an agency, and that Nurse Keady was an agency employee who had been a home health aide until about one month before she first worked at the facility, when she changed her status to LPN. Tr. at 41, 77. The record is silent as to how or why this change in status occurred. Contrary to Petitioner's inferences, nothing in the record suggests that Nurse Keady worked at St. Clare's Hospital in any capacity. Petitioner has produced an agreement between the facility and an organization called St. Clare's Home Care, the agency that apparently supplied the facility with temporary staff, including Nurse Keady. P. Ex. 44.

4. I discuss at length below how evident this was on July 28 , 1999.

5. It also possible that failure to sign that the medication has been given may in fact indicate that the medication was not given, and the nurse may not accurately remember whether she has given it or not.

6. Based on this silence, Petitioner suggests, without providing any supporting evidence, that Nurse Keady performed competently on those days. In fact, the record simply does not tell us what went on on those days, and no inferences may be drawn. Moreover, even if her performance were adequate on those specific days, she was still unlicensed, and had already demonstrated significant difficulty in coping with the demands of the job. Nor am I convinced that a facility is entitled to notice of staff incompetence before it can be held accountable for their errors. Although not necessary to reach that issue here, it seems that a reasonable distinction could be drawn between situations involving resident accidents, where the facility is not required to "be a guarantor against unforeseeable occurrence (Koester, DAB No. 1750, at 25 - 26; Woodstock Care Center, DAB No. 1726, at 25 (2000)) and those involving instances of staff misconduct or error. A provider is simply responsible for the adequacy of its staff.

7. Resident 1 is also referred to as A.K. See P. Ex 1

8. Resident 2 is also referred to as S.B. See P. Ex 1.

9. Resident 4 is also referred to as M.L. See P. Ex 1.

10. Inasmuch as I conclude that the facility's deficiencies constitute substantial noncompliance under 42 C.F.R.§§ 483.20 and 483.25, without regard to 483.13(c), this determination is somewhat academic.

11. In her written statement, Interim Administrator, Janice Brown, indicates that on July 29, she and Nurse Witt discussed with Nurse Keady the events of July 28. After their discussion, she instructed Nurse Keady to write "a statement of the events of her shift the previous day." P. Ex. 7. This statement is apparently found at Petitioner's Exhibit 8, the date on that document referring to the date of the incidents described, not the date that it was drafted.

12. In any event, the language of the third page entries is repeated in the survey report form, so the surveyors likely reviewed the complete document. See CMS Ex. 3, at 2 (indicating the observation was made at 11:30 AM by the RN called to assist in providing medications. Also indicating that the ordered Decadron was not administered).

13. Petitioner offered no evidence as to the time that lunch trays are delivered, which could have been useful in pinpointing the times in Nurse Osborne's statement.

14. Nurse Osborne's statement refers to numerous staff who witnessed these events, but Petitioner produced no statements from them as to the timing, and, of course, none of these individuals were called as witnesses.

15. Again, Resident 1's treatment record indicates she was found unconscious at 12:45 PM. P. Exs. 21, 24.

16. Nor am I convinced that the facility subsequently identified its problems in a timely fashion. Diana Matthews, the LPN who reported to the Newtonian Unit for the 3:00 PM to 11:00 PM shift, writes that she was not aware that Resident 2 had become hypoglycemic during the day shift because she had not been given a report on her condition. She only became aware of the episode when she began charting at midnight. P. Ex. 4. Further, even though f acility policy dictated that the outgoing and incoming nurse count the syringes at every shift (Tr. at 54), the syringes were not counted between the day and evening shifts, so evening staff did not know why the residents were so ill until about midnight when the outgoing evening and the incoming night nurse counted syringes. Tr. at 54; P. Ex. 4.

17. Petitioner correctly asserts that CMS did not complain specifically about its written policies and procedures. However, this fact does not establish compliance with section 483.13, and by suggesting that it does, Petitioner has reversed the parties' respective burdens. The fact of neglect satisfies CMS' prima facie burden. Petitioner must then demonstrate its compliance. Hillman Rehabilitation Center, DAB No. 1665 (1998); see Emerald Oaks at 9, et seq., for a thorough discussion of the correct analytical framework for ALJ hearings on disputed issues of fact.

18. I also find pointless any effort to determine, based on the record before me, the relative contributions to Resident 3's rapid decline played by 1) her receipt of the insulin overdose, 2) the facility's failure to administer her 9:00 AM respiratory medications, and 3) other causes. Whether the nursing failures, individually or in combination, were directly responsible, each had the potential for causing irreparable harm, so the standard is met.

19. Indeed, CMS might have imposed a CMP starting July 28, when the actual harm occurred, or even as early as July 2, when the facility first allowed an unlicensed and unqualified person to perform the duties of an LPN.