SUBJECT:

Parkway Manor Health Center,

Petitioner,

Centers for Medicaid & Medicare Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) ⁽¹⁾ to impose a Civil Money Penalty (CMP) against Parkway Manor Health Center (Petitioner) for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and Medicaid. The CMP of $5,000.00 per day from September 22, 2000 through October 1, 2000 is based on a finding of immediate jeopardy.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner on April 19, 2001, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. §§ 488.408(g), 498.40.

On February 22, 2001, CMS informed Petitioner that, based on surveys conducted on August 22, 2000, September 22, 2000, and October 2, 2000 by the New Jersey Department of Health and Human Services (State survey agency), it was imposing the following remedies due to Petitioner's failure to be in substantial compliance with the applicable federal requirements for nursing homes participating in Medicare and Medicaid:

•A CMP in the amount of $50.00 per day from August 22, 2000 through September 22, 2000.

•A CMP of $5,000.00 per day from September 22, 2000 through October 1, 2000, a 10 day period of noncompliance that constituted immediate jeopardy.

•A Denial of Payment for New Admissions (DPNA) effective September 22, 2000 through October 1, 2000. ⁽²⁾

By letter dated April 3, 2002, Petitioner withdrew its appeal of the deficiencies related to the August 22, 2000 survey that had resulted in the imposition of the $50.00 per day CMP from August 22, 2000 through September 22, 2000. Consequently, I dismissed that portion of Petitioner's hearing request by order dated May 1, 2002.

At the hearing conducted July 23, 2003, CMS offered 37 exhibits identified as CMS Exs. 1-37. Petitioner offered 10 exhibits identified as P. Exs. 1-10. The parties' exhibits were admitted into evidence without any objection. Tr. at 9. Both parties used expert witnesses: Dr. Nilsa Gutierrez testified for CMS and Dr. Antonio Ciccone testified for Petitioner. I found both of these doctors to be qualified to testify as experts as to the care of patients on Coumadin therapy. The only other witness at the hearing was Alice Caldwell, a surveyor with the State survey agency.

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

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that, from September 22, 2000 through October 1, 2000, Petitioner was in substantial noncompliance at the immediate jeopardy level. I further find that CMS was authorized to impose a CMP against Petitioner at the rate of $5,000.00 per day from September 22, 2000 through October 1, 2000.

II. Applicable Law and Regulations

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

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

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long term care facility that is not complying substantially with federal participation requirements. Part 483 of 42 C.F.R. provides that facilities that participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. §§ 488.10-488.28. The regulations contain special survey conditions for long term care facilities. 42 C.F.R. §§ 488.300-488.335. Under Part 488, a State or CMS may impose a CMP against a long term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance and runs until the date substantial compliance is achieved or the provider agreement is terminated.

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

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

42 C.F.R. § 488.301.

The regulations specify that a civil money penalty that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of civil money penalties, from $3,050 per day to $10,000.00 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1), (d)(2). The lower range of civil money penalties, from $50 per day to $3,000.00 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(2).

"Immediate jeopardy" is defined to mean:

a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. ⁽³⁾

42 C.F.R. § 488.301.

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

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

2. The facility's financial condition.

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

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997).

The Act and regulations make a hearing available before an Administrative Law Judge to a long term facility against whom CMS has determined to impose a CMP. Act § 1128A(c)(2), 42 C.F.R. §§ 488.408(g); 498.3(b)(12), (13). The hearing before an Administrative Law Judge is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd 941 F.2d 678 (8^th Cir. 1991).

III. Issues

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

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

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

IV. Findings and Discussion

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

A. Petitioner was not in substantial compliance with federal participation requirements from September 22, 2000 through October 1, 2000.

CMS's prima facie case as to Petitioner's failure to substantially comply with federal participation standards is based on Petitioner's care of Resident #1. The facts related to her care are as follows:

On June 26, 2000, Resident #1 was admitted to Parkway Manor from Beth Israel Hospital under the care of Raoul Elias, M.D. (Dr. Elias), her privately engaged attending physician. CMS Ex. 11. Resident #1 was in very poor health, suffering from diabetes mellitus, coronary artery disease, congestive heart failure, atrial fibrillation, rheumatoid arthritis and a decubitus ulcer. Id.

On admission, Dr. Elias ordered numerous medications for Resident #1 including 2.5 milligrams (mg) of Coumadin, an anticoagulant. CMS Ex. 12, at 2. The Coumadin was prescribed for atrial fibrillation (i.e., abnormal heart rhythm) which put her at an increased likelihood for a stroke. CMS Ex. 34, at 2; Tr. at 160. It was to be administered "PO" and "OD," meaning orally once a day. CMS Ex. 12, at 2; Tr. at 38. On June 27, 2000 and daily thereafter until August 31, 2000, Resident #1 was given 2.5 mg of Coumadin as prescribed. CMS Exs. 18, at 1; 19, at 1; 20, at 1.

On August 31, 2000, when Resident #1 was transferred to another floor, a nurse erroneously transcribed the medication order so that 2.5 mg Coumadin was directed to be administered twice daily. CMS Ex. 21, at 1. On September 1, and continuing on September 3 through September 11, Resident #1 was given 2.5 mg of Coumadin twice daily. Id.

In order to monitor the effect of Coumadin on Resident #1's blood, Dr. Elias wrote "PT twice a week" in the Physician's Orders form dated June 27, 2000. CMS Ex. 12, at 2. With this entry, Dr. Elias intended to order a prothrombin time or "protime" (PT) test. Tr. at 30; see also P. Br. at 5. Similar entries, "PT TWICE WEEKLY," were made on the August and September medication order forms. CMS Ex. 13, at 5, 6. Petitioner asserts that its nursing staff did not recognize Dr. Elias's entries as an order for prothrombin testing and mistook the order as one for physical therapy. CMS Ex. 2, at 1-2.

Dr. Elias subsequently examined Resident #1 on July 22, 2000 but apparently failed to recognize the absence of PT test results. CMS Ex. 17, at 16; Tr. at 165. On August 7, a pharmacy consultant added a progress note in the patient chart stating "Consider periodic PT/INR?" (INR stands for International Normalized Ratio). CMS Ex. 28, at 16; CMS Ex. 15, at 1. Dr. Elias initialed the "Agree" column under "physician response" and a PT/INR was subsequently performed on August 8. The PT/INR revealed a PT blood clotting time of 15.6 seconds and an INR of 1.9. CMS Ex. 17, at 24. Dr. Elias was notified of the test results and did not place new orders into the patient's chart. Id. Dr. Elias subsequently visited Resident #1 on August 21, 2000 and on August 27, 2000, as evidenced by his initials in the patient's chart. Id. at 27, 31. There is no evidence in the record to indicate that Dr. Elias ever alerted the staff to the fact that PT testing was not being conducted, or vice versa.

On September 12, the district nurse discovered the medication error consisting of a double dosage of Coumadin. CMS Ex. 17, at 39. Dr. Elias was notified that day. Id. Resident #1 had already received a dose of 2.5 mg of Coumadin in the morning of September 12, before the error was discovered. CMS Ex. 21. Upon being informed of the error, Dr. Elias ordered a PT/INR test that revealed a PT of 19.9 and an INR of 3.3. CMS Ex. 22, at 1. Dr. Elias continued Resident #1 on a daily regimen of 2.5 mg of Coumadin. CMS Ex. 17, at 40.

According to the routine medications forms, Resident #1 was given 2.5 mg. of Coumadin on September 13, 14, 15 and 18 pursuant to Dr. Elias's orders. CMS Ex. 21, at 2, 3. During this time, Dr. Elias was informed about the following PT/INR tests results for Resident #1: on September 13, a PT of 22.2 and INR of 4.2 (CMS Ex. 22, at 2; CMS Ex. 17, at 41); on September 15 a PT of 29.6 and INR of 8.1 (CMS Ex. 22, at 3; CMS Ex. 17, at 42); on September 18 a PT of 35.6 and an INR of 12.3 (CMS Ex. 22, at 4; CMS Ex. 17, at 44) and on September 20, 2000 a PT of greater than 40, a result that was so high that an INR could not be calculated (CMS Ex. 22, at 5). On September 13, Resident #1 began experiencing intermittent nausea, vomiting, and diarrhea. CMS Ex. 17, at 41.

On September 20, 2000, Petitioner's staff informed Dr. Elias that Resident #1 developed a large hematoma at the site where blood was drawn that morning, that she had bleeding from her elbow and heel around 3:30 - 3:45 p.m., and that at 9 p.m., Resident #1 had a moderate amount of blood in her diaper, as well as moderate amount of bleeding in the right buttock area where an injection had been given. CMS Ex. 17, at 45-46. At 9:50 p.m., Dr. Elias ordered Resident #1 transferred to the emergency room of Columbus Hospital for evaluation. Id. at 46.

Upon admission to the hospital at 1:50 a.m. on September 21, Resident #1's diagnosis was "Coumadin toxicity." CMS Ex. 7, at 8, 9. Resident #1 was treated with Vitamin K, which is the standard treatment for Coumadin toxicity. CMS Ex. 7, at 10; Tr. at 195. Resident #1 was discharged from the hospital on October 19, 2000. Upon discharge, the principal diagnosis, i.e., "the condition responsible, after study, for the admission," was again listed as Coumadin toxicity. CMS Ex. 7, at 1. There were multiple secondary diagnoses and complications also listed. Id.

On September 21, 2000, the Director of Nursing (DON) called the State agency to report the medication error. CMS Ex. 17, at 48. The only evidence in the record related to when the DON was informed of the medication error is a "Medication Incident/Error Report/Adverse Drug Reaction Form" dated September 21, 2000, the nursing note dated September 21 about the DON's call to the State survey agency, and the note on the State survey agency call record indicating that the caller was told about the error on September 21. CMS Ex. 23, CMS Ex. 17, at 48, and CMS Ex. 5, at 2.

1. Petitioner failed to ensure that residents were free of any significant medication errors as required by 42 C.F.R. § 483.25(m)(2). (Tag F333).

Section 483.25(m)(2) requires that the facility must ensure that residents are free of any significant medication errors. The State Operations Manual (SOM) defines a significant medication error as one that "causes the resident discomfort or jeopardizes his or her health or safety." http://www.cms.hhs.gov/manuals/pub07pdf/AP-P-PP.pdf at PP-129. ⁽⁴⁾ Jeopardize means "to expose to loss or injury." http://dictionary.reference.com. Therefore, in this context, a significant medication error is one that exposes a resident's health or safety to harm.

The facts regarding the medication error are not in dispute. Resident #1's treating physician prescribed Coumadin 2.5 mg once daily to Resident #1. Nursing staff erroneously transcribed the medication order and administered 2.5 mg twice a day for 10 days.

In order to establish a prima facie case that Petitioner was not in substantial compliance with § 483.25(m)(2), CMS must show the error exposed Resident #1's health to harm and created the potential for more than minimal harm. 42 C.F.R. § 488.301.

CMS established a prima facie case as to this element. Coumadin is an anticoagulant that operates by inhibiting Vitamin K clotting factors. Tr. at 146. The most serious risk associated with Coumadin therapy is hemorrhage of tissues or organs because of decreased blood clotting level. CMS Ex. 34, at 2; CMS Ex. 28, at 6. Coumadin induced hemorrhages can be fatal. CMS Ex. 28, at 6. Coumadin must be precisely administered in order to avoid damaging side effects and it has several attributes that make its administration challenging. First, Coumadin has a narrow therapeutic range that has to be determined based on the particular patient's condition; too little Coumadin will be ineffective for a patient's condition while too much Coumadin exposes a patient to risk of bleeding. Id. Second, Coumadin has a long half-life which means that it stays in the body and the anticoagulant effect of a dose may be delayed 72 to 96 hours. Id. at 2. Third, Coumadin's effect is dependent on other variables such as "the patient's clinical status, all of their medical conditions, and their drug/drug interactions." Tr. at 147.

Resident #1 was an elderly woman with multiple medical problems who was taking at least six other drugs that potentiate the anticoagulating effects of Coumadin. ⁽⁵⁾ Between June 27 and August 31, 2000, Resident #1 was given 2.5 mg of Coumadin daily without experiencing adverse side effects. Beginning September 1, 2000, staff erroneously doubled Resident #1's dose of Coumadin so that she received 5 mg over ten days. Therefore, Petitioner doubled a dose of a dangerous drug over a ten-day period on a resident who was particularly susceptible to the drug's anticoagulating effect. Dr. Gutierrez testified that this error was likely to cause serious harm to Resident #1. Tr. at 195, 201, 210-212. Based on the medical literature about Coumadin (CMS Exs. 28, 29) and the testimony of Dr. Gutierrez, I find that this was an error that jeopardized Resident #1's health and safety and plainly had the potential for causing more than minimal harm. Therefore CMS has made a prima facie case as to substantial noncompliance.

Petitioner argues this was not a "significant" medication error because "the patient did not suffer actual harm or the potential for harm as a result of the medication error." P. Br. at 12. A finding of actual harm is not necessary to concluding that Petitioner was in substantial noncompliance. 42 C.F.R. § 488.301. Therefore, I need only consider whether the medication error jeopardized Resident #1's health or safety and had the potential for causing more than minimal harm.

To support its assertion that the medication error did not create the potential for harm, Petitioner relied on Dr. Ciccone and cites transcript pages 251 through 260. P. Br. at 12. Dr. Ciccone testified that the normal range for Coumadin dosage is 2.5 to 5 mg. Tr. at 253. Based on his review of Resident #1's records, he stated that giving Resident #1 5 mg of Coumadin for 10 days would not "in and of itself" put her at any risk of harm. Tr. at 254. Petitioner's Counsel inquired further regarding Dr. Ciccone's statement:

Q. Well, when you say "in and of itself," that [5 mg for 10 days] wouldn't have, what else would go into your answer?

A. The monitoring of that five milligram dose.

Q. So the monitoring is important?

A. Yes.

Tr. at 254; see also Tr. at 284.

Dr. Ciccone then goes on to testify as to why he believed the medication error did not have an actual adverse impact on Resident #1 and why he believed that the problems she did experience were a result of her treating's physician's actions after the medication error was discovered. ⁽⁶⁾

For the following reasons, I find that Dr. Ciccone's testimony does not show that the medication error did not jeopardize Resident #1's health and safety and did not have the potential for causing more than minimal harm.

•First, while Dr. Ciccone testified that 5 mg is within the normal range of Coumadin dosage, he did not testify that 5 mg was appropriate for Resident #1. As both experts agreed, Coumadin is a drug that must be individually and carefully administered in light of many factors, including age, medical condition, diet, and other medications in order to establish the appropriate dose for an individual patient. ⁽⁷⁾ Tr. at 146-147, 255-256, 273. Therefore, the fact that 5 mg is an appropriate dose for certain people does not mean that 5 mg did not have the potential for causing harm to Resident #1.

•Second, Dr. Ciccone testified the administration of 5 mg would not put Resident #1 at risk of harm if there was also monitoring of that dosage. However, as we know, there was no "PT" monitoring, which is what I infer Dr. Ciccone meant by "monitoring." See Tr. at 252. Further, even if Dr. Ciccone did not mean "PT" monitoring, Petitioner's staff performed no other type of monitoring related to the impact of the error because the staff did not realize there was an error. Therefore, there was no monitoring of any kind.

•Third, the fact that Dr. Ciccone stated that the increased dosage should have been accompanied by monitoring shows that the 5 mg could cause adverse side effects and there was risk of harm. (Monitoring is mandated regardless of the dosage. When the dosage was doubled, of course, the danger present due to lack of monitoring took on a very heightened significance.)

Therefore, even if I accept the cited portion of Dr. Ciccone's testimony as credible, it does not establish that the doubling of Resident #1's Coumadin dosage for ten days without monitoring did not jeopardize Resident #1's health and safety and did not create the potential for causing her more than minimal harm.

Based on the preceding discussion, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(m)(2).

2. Petitioner failed to provide services that met professional standards of quality as required by 42 C.F.R. § 483.20(k)(3)(i). (Tag F281).

Section 483.20(k)(3)(i) requires that the services provided or arranged by the facility must meet professional standards of quality. ⁽⁸⁾ CMS alleges that Petitioner failed to comply with the requirement because Petitioner failed to implement the physician's order for PT testing; erroneously administered Coumadin 2.5 mg twice a day instead of once a day; failed to report the medication error pursuant to its error-reporting policy; and allowed the attending physician to fail to note that PT lab results were not available. Below I discuss the first three grounds and conclude that they establish that Petitioner was not in substantial compliance with § 483.20(k)(3)(i).

a. Failure to implement physician's order for PT testing

The Board has held that facility staff's failure to carry out a physician's order constitutes failure to meet professional standards of care under 42 C.F.R. § 483.20(k)(3)(i). Georgian Court Nursing Center, DAB No. 1866, at 8 (2003); Emerald Oaks, DAB No. 1800, at 37 (2001). Thus, Petitioner's staff's failure to follow the doctor's order for PT testing constitutes a prima facie showing of a failure to provide services that meet professional standards of quality.

Under the "Labs" portion of his orders, Dr. Elias wrote "PT twice weekly." CMS Ex. 13, at 5, 6. PT testing measures the "activity of blood clotting factors which you have inhibited with Coumadin use." Tr. at 149. The PT establishes the degree of coagulation. The INR is a calculation based on the PT that "provides a common basis for communication of PT results and interpretations of therapeutic ranges." CMS Ex. 28, at 16. It gives doctors a "consistent measure of the prothrombin time, especially if the PT studies are conducted in different laboratories." Tr. at 149. Thus, the INR is a standardized measure of anticoagulation - the higher the INR, the higher the degree of anticoagulation and the higher the anticoagulation, the higher the risk of bleeding. Id. at 150. INRs are evaluated in relation to a particular patient's condition, i.e., whether the INR is within the therapeutic range for that patient's condition. ⁽⁹⁾ Tr. at 151. "An INR of greater than 4.0 appears to provide no additional therapeutic benefits in most patients and is associated with a higher risk of bleeding." CMS Ex. 28, at 15.

CMS's expert Nilsa Gutierrez's affidavit facilitates an understanding of why PT monitoring is required. CMS Ex. 34 at 2, 3. As Dr. Gutierrez explained:

Coumadin (Warfarin Sodium) is an anticoagulant, i.e., it acts to inhibit the formation of blood clots by suppressing the liver's production of vitamin K dependent factors crucial to blood clotting. Coumadin is prescribed for the treatment of various thromboembolic disorders, such as atrial fibrillation, as well as for the reduction of the risk of stroke related to atrial fibrillation and other heart disorders. The most serious risk associated with Coumadin therapy is hemorrhage of tissues or organs because of decreased blood clotting level. It is thus a basic standard of professional care that periodic monitoring of a patient's blood clotting level while on Coumadin is essential. See also CMS Exhibit 28 (Manufacturer's Prescribing Information) at p. 8; Physician's Desk Reference (2002) at p. 1246. Each individual's blood clotting response to Coumadin varies, depending on factors such as the person's age, physical condition, and interactions with the individual's drug regimen. In addition, elderly patients and patients with congestive heart failure may be particularly sensitive to the effects of Coumadin, requiring more frequent laboratory monitoring.

CMS Ex. 34, at 2-3 (emphasis added); see also CMS Ex. 28, at 3, 8.

At the hearing, Dr. Gutierrez also testified to the importance of monitoring and to the fact that it is regarded as a professional requirement in the administration of Coumadin. She stated that "it's impossible to disassociate" Coumadin and PT monitoring (Tr. at 196); and that when a resident receives Coumadin, they have to be monitored. This is bread and butter. This is routine medical care. This is not rocket science. This is not complicated, especially because Coumadin is a medication that is used fairly often, and everyone knows that that's what ought to be occurring.

Id. at 197-198.

Dr. Gutierrez went on to say that there was an "institutional responsibility here as well." Id. at 198. Particularly, Petitioner's nurses should have noticed that absence of monitoring. Id. at 197.

While Petitioner concedes that Resident #1's doctor intended to order bi-weekly "Pro-time" testing (P. Br. at 5), Petitioner asserts its staff's failure to conduct PT monitoring did not constitute substantial noncompliance. Specifically, Petitioner contends that the staff's failure resulted from Dr. Elias' failure to order the test in accordance with commonly accepted nomenclature. ⁽¹⁰⁾ Accordingly, reasons Petitioner, the nursing staff's assumption that Dr. Elias had ordered physical therapy (PT) rather than PT testing was reasonable in light of the current standards for abbreviation described by Dr. Ciccone in his testimony. Tr. at 262. Furthermore, states Petitioner, it was Dr. Elias' responsibility, as opposed to the nursing staff's responsibility, to ensure that his orders were being properly carried out. P. Br. at 17.

The evidence shows that Petitioner failed to provide services that met professional standards of quality by not monitoring Resident #1's blood clotting time twice a week as ordered by the physician. CMS Ex. 12, at 2. I do not find Petitioner's arguments here persuasive for the following reasons.

•First, when Coumadin is prescribed, the standard practice of medical care requires that the anticoagulation effect of the Coumadin be measured periodically. CMS Ex. 34, at 3; Tr. at 148, 196-198. Thus, when Dr. Elias prescribed Coumadin to Resident #1 on June 26, 2000, he also ordered PT testing twice a week. ⁽¹¹⁾ CMS Ex. 12, at 2. The order for measurement of the anticoagulation effects of Coumadin appears in the LABS (frequency) portion of the physician's orders, along with other laboratory tests directed by the doctor. I fail to see how the insertion of "PT twice a week" in the portion of the Physician's orders reserved for laboratory testing could be mistaken for "physical therapy."

•Second, on June 27, 2000, Resident #1 underwent a physical therapy evaluation, and a need was determined for physical therapy six times a week for four weeks with a view to improving such things as bed mobility, transfers, range of motion, and balance. ⁽¹²⁾ The facility staff could not be providing physical therapy twice a week and simultaneously provide that same treatment six times a week. Therefore, they should have inquired as to the meaning of the direction "PT twice weekly."

•Third, even if the doctor's order was ambiguous or confusing, if the staff had been attentive to the physician's orders and the professional standards associated with Coumadin, it should have at least detected a conflict that required physician clarification. If the facility staff truly believed that PT was an acronym for physical therapy, there was an additional reason for contacting the treating physician, because that meant that there was no provision in the medical orders for Coumadin monitoring. In this regard, the State surveyor testified that it would be a basic standard of nursing care to notify a physician if PT monitoring was not ordered. Tr. at 29-30. Dr. Gutierrez also testified that the staff should have known that Resident #1's PT level should have been monitored. Tr. at 198. "Clarifying ambiguous order regarding patient care is a professional responsibility of nurses." Emerald Oaks, DAB No. 1800, at 45 (2001).

Finally, Petitioner argues in its response brief (P. Response at 7) that PT testing is not the exclusive method of monitoring the anticoagulation level of Coumadin in the blood. While conceding that no laboratory tests were performed "on a daily basis," ⁽¹³⁾ Petitioner contends that there is substantial evidence in Resident #1's medical record to show that she was physically monitored during the period at issue. I find Petitioner's argument here to be woefully flawed for several reasons. I must note at the outset that the treating physician ordered PT testing as the method of monitoring the resident's Coumadin level. Nowhere in the record is there an indication that the facility was authorized to exercise medical discretion to utilize alternative options of monitoring. Additionally, Petitioner has failed to indicate how it was able to determine the resident's blood clotting level by physical examination or visual observation. ⁽¹⁵⁾ Furthermore, it is evident from the record that Petitioner did not make a reasoned determination to forgo PT testing in favor of physical examination, but rather, has engaged in a creative reconstruction of events in order to legitimize its failure to carry out the treating physician's order to perform PT monitoring twice a week.

Petitioner's failure to conduct PT testing for Resident #1, as discussed above, establishes that Petitioner failed to provide services that met professional standards of quality and that the failure had the potential for more than minimal harm.

b. The medication error

Although Petitioner denies that CMS has identified any professional standards of quality with which the facility has failed to comply, it does admit incurring a medication error. However, Petitioner seeks sanctuary in the claim that the medication error was caused by a transcription error. P. Br. at 17. Of course, Petitioner does not explain how the alleged transcription error results in absolution. ⁽¹⁶⁾ But I do note that whatever error the facility may have committed that resulted in a medication error only serves to reveal the underlying cause of Petitioner's violation of 42 C.F.R. § 483.20(k)(3)(i). I find nothing exculpatory in that.

Petitioner also seeks refuge in the fact that the regulations "contemplate that at least some medication errors will occur. Section 483.25(m)(1) excuses medication errors which occur at a rate of less than 5%." P. Response at 8. Petitioner therefore argues that the fact a medication error occurred does not constitute "definitive evidence that Parkway Manor failed to meet professional standards of care." Id. at 9. I agree with Petitioner that the mere existence of an error is not "definite evidence" of failure to meet professional standards. However, in this case, I am not treating the simple fact that a medication error occurred as "definitive evidence." Rather, I have considered the seriousness of the error, including its risk for harm, and concluded that it constituted a failure to meet professional standards of care.

The medication error, as discussed above, establishes that Petitioner failed to provide services that met professional standards of quality and that the failure had the potential for more than minimal harm.

c. Staff's failure to properly report the medication error

CMS asserted that Petitioner's failure to follow its policies for reporting medication errors constituted a failure to provide services that met professional standards of quality. The surveyor testified that such a failure diminishes a facility's ability to ensure that a resident is properly assessed and cared for after an error. Tr. at 31.

Petitioner contends that it followed its policies for reporting errors, that CMS has not faulted its policies, and therefore it should not be cited for substandard services. P. Br. at 21. While Petitioner did not produce a policy at the time of the survey (Tr. at 101), it did submit a policy with its Plan of Correction (POC). CMS Ex. 2, at 16-17. The policy reflects an effective date of October 1998. The policy states that the "Nurse will document the incident in the Nurses's notes and on the appropriate Facility Incident Report" and that the "Incident Report will be forwarded to the Director of Nurses." Id.

The nursing notes indicate that the error was discovered on September 12 by a charge nurse, which apparently is a supervising nurse. CMS. Ex. 17, at 39. When the error was discovered, it was reported to Resident #1's doctor, Dr. Elias. Id. There is no evidence to show that the error was reported to the DON upon discovery. Rather, the error appears to have been reported to the DON, Administration, and the Medical Director on September 21 and certainly no earlier than September 20, the date when Dr. Elias determined Resident #1 would need to be sent to the hospital. CMS Ex. 5, at 2. On September 21, the date Resident #1 was hospitalized, a "Medication Incident/Error Report/Adverse Drug Reaction Form" was completed and sent to the DON, Administration, and Medical Director. CMS Ex. 23.

I conclude that Petitioner did not follow its policy for reporting medication errors. The policy requires the error to be documented on the "appropriate Facility Incident Report" and the report forwarded to the DON. Petitioner offered no testimony as to what this report might be and did not assert that any report was made to the DON at the time of the discovery of the error. The record does contain a completed "Medication Incident/Error Report" form dated September 21, 2000. CMS Ex. 23. Presumably this, or some similar type of report, is the report called for by the policy. The Medication Incident/Error Report requires distribution to the DON, the Medical Director, and Administrator. It was not completed until September 21, 2000, the day Resident #1 was hospitalized. While Petitioner's policy contains no explicit deadline for filing a report to the DON, it is reasonable to conclude that such a report should be filed promptly and certainly sooner than eight days after the incident. Therefore, I conclude that the policy required a report to the DON; no report was made at the time the error was discovered; a report was made eight days later at the point Resident #1 had to be hospitalized; and this report was untimely and did not comply with the policy. Additionally, the DON and Administrator could not even find a copy of the policy during the survey. Tr. at 54, 58. From that, I infer that the policy was not well disseminated or familiar to the administration or the staff.

Furthermore, the facts in this case show why failure to notify the DON and Medical Director of this type of error has the potential for causing more than minimal harm. In this case, both experts agreed that Resident #1's physician mismanaged Resident #1's care after he was informed of the medication error. Tr. at 190, 265. However, had the DON or Medical Director been aware of the staff's error, Resident #1 may have received additional medical oversight that should have prevented or, at a minimum, ameliorated Dr. Elias' subsequent mismanagement.

Finally, I note that, inexplicably and shockingly, where the form directs the reporter to "specify effect(s) of incident/error on resident" the reporter stated "No (sic) noted [at] this time. [No] bruises, irregular bleeding noticed." CMS Ex. 23. The day the report was completed, Resident #1 was in the hospital with Coumadin toxicity and the nursing notes were full of indications of problems related to the medication error such as abnormal bleeding and elevated INRs. CMS Ex. 17, at 44-46 This misdescription of Resident #1's condition says to me that staff first tried to hide the error by not reporting it to the DON, and then tried to hide the scope of the error by failing to describe the resident's present condition.

Failure to report a significant medication error pursuant to facility policies is a failure to provide services that meet professional standards of quality. This failure had the potential for causing more than minimal harm to Resident #1.

3. Petitioner failed to provide Resident #1 with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being as required by 42 C.F.R. § 483.25. (Tag F309).

The regulations at 42 C.F.R. § 483.25 require that each resident must receive and the facility must provide the necessary care and services to attain and maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. This regulation does not require the facility to guarantee positive outcomes, but it does place on it "an affirmative duty to provide services . . . designed to achieve those outcomes to the highest practicable degree." Woodstock Care Center, DAB No. 1726, at 25 (2000).

CMS argues that Petitioner was not in substantial compliance with § 483.25 because of the medication error, failure to monitor Resident #1's blood clotting levels, and failure to report the medication error to the DON and Administration. CMS Br. at 32-33.

Petitioner argues that CMS cannot cite a deficiency under § 483.25 because it has also cited a specific section of the regulation, § 483.25(m)(2), dealing with significant medication errors. I reject this argument. CMS bases its citation of § 483.25 on facts extraneous to the medication error. For the following reasons, I conclude Petitioner was not in substantial compliance with § 483.25 as well as § 483.25(m)(2).

First, Petitioner's failure to obtain PT monitoring for Resident #1 was a failure to provide care to attain and maintain her highest practicable physical well-being. As Dr. Gutierrez said in her affidavit: "It is thus a basic standard of professional care that periodic monitoring of a patient's blood clotting level while on Coumadin is essential . . . . In addition, elderly patients and patients with congestive heart failure may be particularly sensitive to the effects of Coumadin, requiring more frequent laboratory monitoring." CMS Ex. 34, at 2-3. Additionally, Petitioner's own expert testified that he would have monitored Resident #1 "at least once to twice a month." Tr. at 263. Therefore, Petitioner's failure to follow Dr. Elias' PT monitoring orders; its failure to clarify what Petitioner now contends were Dr. Elias' misleading or ambiguous orders, and its failure to raise independently why no PT monitoring had been ordered for Resident #1 violates § 493.25.

Petitioner seeks to shield itself from a finding of noncompliance under this regulation, and other regulations, by focusing on the shortcomings of Dr. Elias, i.e., his failure to order PT testing pursuant to commonly accepted standards and his failure to realize PT testing was not being conducted. P. Br. at 20. Similarly, when discussing whether its noncompliance caused harm or constituted immediate jeopardy, Petitioner again points the finger at Dr. Elias' mismanagement of Resident #1's care before and after the discovery of the error. P. Br. at 1, 14-15, 18, 25, 26.

I reject Petitioner's arguments. Sections 1819(b)(2) and 1919(b)(2) of the Act provide that Medicare or Medicaid-certified nursing facilities must plan for and provide services to meet the medical needs of each resident to help each resident maintain the highest practicable physical, mental and psychosocial well-being. Further, sections 1819(d)(4(A) and 1919(d)(4)(A) provide that a facility "must operate and provide services in compliance . . . with accepted professional standards and principles which apply to professions providing services in such a facility." These provisions create an independent duty to consider whether services provided to a resident are services that meet the medical needs of each resident and whether such services comply with accepted professional standards. Therefore, while a "facility has no regulatory obligation to dispute the doctor's medical judgment in resolving an ambiguous set of medical indicators to arrive at a diagnosis or to challenge a treatment order that was not on its face inappropriate for the diagnosis," it must intercede where it has reason to know that the care provided by the physician is "on its face inappropriate." Beverly Health and Rehab-Springhill, DAB No. 1696, at 44 (1999). In this case, failure to regularly monitor the coagulation level of Resident #1's blood for several months was on its face medically inappropriate. Petitioner's nurses should have known it was inappropriate. Tr. at 29, 30. Therefore, Dr. Elias' shortcomings, in this case, do not excuse Petitioner's failure to abide by the regulatory standards.

Finally, as discussed in the prior section, the staff's failure to properly report the medication error also constitutes a failure to provide the necessary care and services to attain and maintain the highest practicable physical, mental, and psychosocial well-being. Had staff properly reported the error, Resident #1 may not have been subjected to her own doctor's mismanagement of her treatment after the medication error.

4. Petitioner failed to ensure that the medical care of Resident #1 was supervised by a physician in violation of 42 C.F.R. § 483.40(a). (Tag F386).

Section 483.40(a)(1) requires that the facility "must ensure that . . . the medical care of each resident is supervised by a physician." The supervision exercised by the physician encompasses the duty to review the resident's total program of care, including medications and treatments, at each visit required by § 483.40(c). 42 C.F.R. § 483.40(b)(1)-(3).

CMS argues that Petitioner failed to comply with this regulation because, in his reviews, Dr. Elias failed to notice that his PT testing order had not been implemented and therefore he did not know if 2.5 mg Coumadin was therapeutic or safe for Resident #1. CMS Br. at 37-38. CMS assumes that the duty to "ensure" the doctor is reviewing a resident's medications includes ensuring that the doctor is actually reviewing the plan of care and medications, as opposed to simply signing the form saying that he conducted a review.

Petitioner responded that Dr. Elias made the visits required by § 483.40(c) and signed the forms as required by § 483.40(b)(2) and (3) (P. Br. at 23), and that "failure by the attending physician to deliver quality care does not necessarily lead to the conclusion that he did not review the resident's total program of care." P. Response at 14. It concludes:

Respondent does not contend that Parkway Manor is required to guarantee that independent physicians will never provide substandard care. Instead, Parkway Manor is required to have procedures in place to protect Residents from such conduct. There is no indication that Parkway Manor was negligent in this regard.

Id.

Petitioner is correct that facilities are not required to guarantee that independent physicians will never provide substandard care. However, as discussed in the prior section, a facility does have an independent responsibility to act where it has reason to know that the care provided by the physician is "on its face inappropriate." Beverly, DAB No. 1696, at 44. In this situation, Petitioner should have known the doctor's failure to receive results of regular PT testing for a patient on Coumadin was inappropriate and, therefore, should have known that the doctor could not be actually reviewing Resident #1's total plan of care, including medications.

For the reasons set forth above, I conclude that CMS has 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. Petitioner, on the other hand, has not overcome CMS's showing by a preponderance of the evidence.

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

As discussed below, I sustain CMS's finding that Petitioner's noncompliance constituted immediate jeopardy because it was likely to cause or did cause serious harm to Resident #1 and other similarly situated residents. Petitioner should have foreseen that a failure to monitor Resident # 1's Coumadin therapy and the failure to exercise due care so as not to incur medication errors, which in this case resulted in the administration of a double dose of Coumadin, was likely to cause serious harm or injury to the resident.

Immediate jeopardy exists where a "provider's noncompliance with one or more requirements of participation has caused or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. For a finding of immediate jeopardy, it is not necessary to show the noncompliance caused serious harm; it is sufficient to show that the noncompliance was likely to cause serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001). Additionally, I must uphold CMS's determination as to immediate jeopardy unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2).

CMS has made a prima facie showing that Petitioner's failure to properly monitor Resident #1's Coumadin therapy placed her at risk of serious injury, harm, impairment, or death. ⁽¹⁷⁾ The anticipated damaging results of failure to monitor Coumadin administration are even more evident when that failure also occurred at a time when the facility was giving the resident a double dosage. The evidence showed that:

•The most serious risk associated with Coumadin therapy is "hemorrhage in any tissue or organ." CMS Ex. 28, at 6.

•Coumadin has a narrow therapeutic range. The manufacturer's instructions state that the therapeutic range for atrial fibrillation is an INR of between 2.0-3.0 and that, for any condition, "[a]n INR of greater than 4.0 appears to provide no additional therapeutic benefits in most patients and is associated with a higher risk of bleeding." CMS Ex. 28, at 15 (emphasis in original). Thus, there is a narrow range in which a dose is therapeutic and a small step between an INR that is therapeutic and an INR that poses increased risk of bleeding.

•Coumadin's effect over time can be modified by many factors such as other medications, diet, and medical condition. CMS Ex. 28, at 8.

•It is standard medical practice to do regular PT monitoring on patients receiving Coumadin. Under the section labeled "PRECAUTIONS," the manufacturer's instructions provide: "Periodic determination of PT/INR or other suitable coagulation test is essential." CMS Ex. 26, at 8 (emphasis in original). Dr. Gutierrez testified that the failure to monitor Resident #1's PT time created a potential for serious injury. Tr. at 195.

Therefore, the record is clear that regular PT monitoring is required for patients receiving Coumadin in order to prevent serious harm.

Petitioner argues that, although Resident #1 was not receiving PT monitoring on a regular basis, this alone did not place her at risk of serious injury or harm. Petitioner relies on the testimony of Dr. Ciccone for the proposition that the effects of Coumadin therapy on a patient's blood clotting level will remain the same so long as there is no change in the patient's medical condition or medications. P. Response at 16; Tr. at 260-261.

Petitioner's assertion that failure to monitor Resident #1 did not place her at risk of serious harm is not supported by the evidence. The record shows as follows:

•Petitioner's expert, Dr. Ciccone, testified that, with a patient like Resident #1, he would order PT/INR "almost every day till I get a trend or values that are within what I feel is acceptable . . . ." After that point, he said, "Then depending on the patient's condition, if nothing changes, if there is no change in her heart failure, then I would do it at least once to twice month." Tr. at 263 (emphasis added).

•Petitioner's argument assumes Resident #1 underwent no change in medical condition or medication and therefore her blood clotting levels remained unchanged as well. Petitioner seeks support for its theory in the results of PT testing performed in August 2000 (CMS Ex. 17, at 24), where according to Petitioner, a PT test revealed normal range. P. Br. at 17. However, Dr. Ciccone's testimony at pages 260 and 261 of the transcript cited by Petitioner cannot serve as a basis to support the proposition that the failure to monitor Resident #1's blood clotting levels did not place her at risk of harm. The testimony referenced by Petitioner only addresses the resident's condition during the 10 days when she was erroneously given twice the dosage of Coumadin and not the whole period during which there was failure to monitor her blood clotting levels.

•Furthermore, during the months that Resident #1 was being administered Coumadin without PT monitoring, she was on several medications "PRN" (as needed). Thus, there could well have been variations in the medications and dosages taken by the resident during the time that Petitioner claims that she was on a stable medication regimen. Additionally, the resident's dietary practices could also have a bearing on the coagulation effects of Coumadin. In fact, the multitude of factors and substances that impact the coagulation effects of Coumadin are so varied and produce results that are so unique to each individual that the Physicians' Desk Reference provides the following special warning in that regard: "Coumadin, a narrow therapeutic range (index) drug, may be affected by factors such as other drugs and dietary vitamin K. Dosage should be controlled by periodic determination of prothrombin time or other suitable coagulation tests." Physicians' Desk Reference 930, 932 (53^rd ed. 1999) (emphasis added).

It is, therefore, senseless to contend that it was safe to assume that the effects of Coumadin on Resident #1's blood clotting levels would remain unchanged after her admission to Petitioner's facility and, therefore, that it was safe to fail to monitor her PT during June, July, August and the beginning of September. During this time, Resident #1 and other similarly situated residents were at risk of having their blood excessively anticoagulated.

Further, even if it is true that during June, July and August Resident #1's coagulation level remained stable, it is also true that Petitioner did not know what that level was. Therefore, inasmuch as no testing had been performed since Petitioner began giving Resident #1 Coumadin, Petitioner did not know if the resident was being consistently maintained within the therapeutic range for her condition. While Petitioner argues that PT testing in August was "normal," ⁽¹⁷⁾ the resident's progress notes reflect that, when tested in August 2000, she was below acceptable therapeutic levels. Dr. Gutierrez testified that, for a patient with atrial fibrillation, the accepted therapeutic range would be between 2 and 3. Tr. at 151. However, on August 8, 2000, the resident's INR was determined to be 1.9. CMS Ex. 17, at 24. At that point, the resident was at risk of suffering a stroke due to her thromboembolic condition (atrial fibrillation) because the Coumadin dosage was not providing the desired protection. ⁽¹⁸⁾ Tr. at 160. Since a baseline had not been established, the facility had no way of knowing whether the resident's Coumadin regimen was sub-therapeutic or excessive from the time the medication was first prescribed in June 2000 until August 2000, when it, apparently, ⁽¹⁹⁾ became aware of the blunder. Tr. at 172.

Thus, by not having in place a system for ensuring that residents on Coumadin therapy were properly monitored, Petitioner placed Resident #1 and other similarly situated residents at risk of suffering serious injury, harm, impairment, or death.

Further, I find CMS made a prima facie case that the medication error was likely to cause serious harm and therefore constituted immediate jeopardy. The side effects of Coumadin are serious and potentially fatal. Dr. Gutierrez testified that, given the nature of Coumadin and Resident #1's medical status, doubling Resident #1's Coumadin dose for ten days was likely to cause serious injury and harm. Tr. at 195, 210-212.

Petitioner did not prove CMS's determination of immediate jeopardy to be clearly erroneous. Petitioner relies on the testimony of Dr. Ciccone who testified at length as to why he felt the medication error had not actually harmed Resident #1. While he also said that the error did not "in and of itself" put her at any risk of harm, he qualified that answer by saying that the increased dosage should have been accompanied by monitoring. Tr. at 254. Further, he testified as to what he would have done for Resident #1 upon discovery of the medication error if she had been his patient. He said he would have stopped the Coumadin; he would have physically examined her within 24 hours; he would have ordered PT/INR tests; he would have ordered "a CBC to rule out one of the complications [anemia] of Coumadin overdose"; he would have checked her urine to make sure there was no bleeding in the urine; he would have asked the nurses to assess her heels to see if there was bleeding; and he would have talked with Resident #1. Tr. at 266. Additionally, as to the PT/INR and CBC tests, he testified he "would have probably done it in the morning and I would have done it at night, and I have called at two in the morning for blood work." Tr. at 267. If the medication error posed no likelihood of serious harm, this list of precautionary measures would be unnecessary. Therefore, this list of precautionary measures is inconsistent with Petitioner's assertions that the medication error was not likely to cause seriously harm to Resident #1.

Finally, I find that the staff's failure to report the medication error compounded the likelihood of harm to Resident #1. Anytime there is serious error, those incurring the error should receive guidance to manage the aftermath of the error in order to avoid its compounding effect. In this case, Resident #1 did not receive the level of medical review that was warranted by the nature of the error.

While not necessary to a finding of immediate jeopardy, I also find that Petitioner's noncompliance actually harmed Resident #1 in that she ultimately suffered from Coumadin toxicity. Below I discuss the evidence as to this point.

Petitioner contends that its noncompliance did not harm Resident # 1, i.e., did not cause the hospitalization and Coumadin toxicity. ⁽²⁰⁾ Petitioner argues "it was the misappropriate care delivered by a single staff physician, and not any deficiency on the part of Parkway Manor, which alone led to Resident #1's harm." P. Br. at 1 (emphasis added). It relies on Dr. Ciccone, who testified that:

[d]eterioration of Resident 1's medical condition, which eventually resulted in her admission to the hospital, was caused by a combination of the medical mismanagement of Resident No. 1's elevated INR by the attending physician from 9-12 and on, including the mismanagement of her medication, many of which had the effect of increasing Coumadin toxicity, and the various medical conditions suffered, many of which also had the effect of increasing Coumadin toxicity.

Tr. at 272.

As explained below, the evidence is in conflict as to whether the medication error, in and of itself, would have caused Resident #1's INR to rise to a dangerous level or resulted in Coumadin toxicity absent Dr. Elias' ordering additional doses of Coumadin:

•Dr. Ciccone testified that, if Dr. Elias had stopped the Coumadin at the time the mistake was reported to him, Resident #1's INR would not have risen above 4.2 and she would not have suffered any bleeding. Tr. at 267-268. Dr. Ciccone bases this conclusion on his representations that (1) Resident #1's age and other medications would make the 5 mg doses act quickly so that their effect would be reflected in the INR within a maximum period of 24 to 48 hours (Tr. at 256); (2) that Resident #1 last received 5 mg on September 11 and her INR on September 13 was just 4.2; (3) without additional doses of Coumadin after September 12, her INR would not have risen above 4.2; and (4) an INR of 4.2 poses very little threat to the patient. Id. at 267-268. Therefore, he concludes that the medication error did not cause Resident #1 any actual harm. See Tr. at 286, 288, 289-290.

•In contrast, Dr. Gutierrez testified that the facility did not have trend information from which it could determine the resident's response to 2.5 mg. of Coumadin daily or 5 mg daily because it had failed to conduct PT tests. Tr. 181-183. She testified that the effect of Coumadin may be measured up to four days later. Tr. at 183; 221, 229. She concluded that, given the lack of trend information, one could not determine whether Resident #1's INR would have risen to 12 if the Coumadin had been stopped after September 12. Tr. at 220-221, 223-224.

I do not have to resolve this conflict in the evidence in order to conclude Petitioner's noncompliance caused actual harm. Even if I assume that Dr. Elias' mismanagement of Resident #1's Coumadin after September 12 was the final cause of her suffering Coumadin toxicity, this intervening event does not shield Petitioner from a finding that its conduct also caused the actual harm that Resident #1 eventually suffered. ⁽²¹⁾ Petitioner's staff failed to follow Dr. Elias' orders for PT monitoring or failed to raise with Dr. Elias the continued need for PT monitoring; Petitioner's staff doubled Resident #1's dose of Coumadin for ten days; and Petitioner's staff failed to properly report the error to the DON as required by its policy. This constellation of noncomplying events put Resident #1 in harm's way. The lack of monitoring meant that when the medication error occurred, its impact could not be properly evaluated. The medication error, at a minimum, anticoagulated Resident #1's blood to the extent that she required even more precise management in order to avoid dire consequences. ⁽²²⁾ The failure to report the error deprived Resident #1 of additional medical oversight any nursing home resident should receive after this type of error. Therefore, Petitioner's noncompliance was so entwined with the doctor's mistakes that it constitutes a failure to provide services that met Resident #1's medical needs and was a cause of the harm Resident #1 suffered.

In view of the above, I conclude that Petitioner has not shown that CMS's determination of immediate jeopardy is clearly erroneous.

C. Petitioner has not shown that it came into compliance prior to October 2, 2000.

Once substantial noncompliance has been established, Petitioner has the burden of demonstrating that it came back into compliance at a date earlier than that determined by CMS. See Coquina Center, DAB No. 1860, at 26 (2002); Barn Hill Care Center, DAB No. 1848, at 15-16 (2002); Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 17 (2002).

In its plan of correction, Petitioner alleged it would take a number of steps to correct the deficiencies identified on the September 22 survey and that it would achieve compliance by September 27. Among other things, Petitioner alleged that it had developed a new Coumadin therapy protocol, by which all residents on Coumadin would have monthly PT and INR testing, unless ordered more frequently by a physician. CMS Ex. 2, at 8, 14-15. Petitioner also submitted a written policy and procedure on documenting and reporting medication administration errors. CMS Ex. 2, at 16-17. According to Petitioner, by September 27, 2000, its professional nursing staff would have been inserviced on "medication administration protocol and related standards of practice." CMS Ex. 2, at 8.

Although Petitioner's plan of correction was "accepted" by the state survey agency (see CMS Ex. 2), such acceptance was conditioned on the state determining that the facility had actually implemented the alleged corrective actions. Thus, Surveyor Caldwell testified that "[a]nything [the facility] state[s] in their plan has to be implemented before they can be put back into compliance." Tr. at 138; SOM § 7304D(4) (the "plan [of correction] must be implemented and the corrective action evaluated for its effectiveness."); 42 C.F.R. 488.454(a).

Although Petitioner's plan of correction alleged that inservicing of its nursing staff "has been delivered," the inservice attendance logs clearly show that, by and including September 27, only 23 of 38 nurses who were to be inserviced had attended (approximately 60%). CMS Ex. 27, at 1-2. Therefore, it appears that a significant proportion of the nursing staff continued to provide care after September 27 without having been inserviced. Petitioner has submitted no evidence that would show otherwise. By October 2, 2000, the date of the revisit, all but three nurses had completed their inservicing. Surveyor Caldwell testified that a sufficient number of staff had been inserviced for her to determine that the facility was back in compliance as of October 2, 2001. Tr. at 78.

Petitioner complains that it is arbitrary for Ms. Caldwell to determine that its failure to inservice 3 of 38 nurses constituted compliance but its failure to inservice 15 of 35 did not constitute compliance. I do not find this arbitrary. Fifteen nurses was approximately 40% of Petitioner's nursing staff. This is a significant number who were yet to be instructed on "medication administration protocol and related standards of practice." CMS Ex. 2, at 8.

The inservicing of the facility's nursing staff was clearly a key component of the facility's corrective action because of the number of nurses involved in not only committing the medication and "transcription" error, but in failing to notice or implement the order for PT monitoring for over two and a half months. Thus, CMS's finding that Petitioner was in substantial compliance only after the State survey agency conducted an onsite visit on October 2, 2000, and verified that the facility had substantially completed implementation its plan of correction, was not clearly erroneous. See also Fairfax Nursing Home, DAB No. 1794, at 22 (2001).

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

CMS imposed a $5,000.00 per day CMP for the period beginning September 22, 2000 and ending October 1, 2000. I agree with CMS that Petitioner's staff exhibited neglect, indifference, and disregard to resident care and safety in failing to implement, or to at least clarify, the order for PT monitoring; in failing to ensure that the attending physician supervised Resident #1's total plan of care; in committing a significant medication error over a 10 day period; and in failing to report the medication error to the DON once the error was discovered. See 42 C.F.R. § 488.438(f).

Petitioner contests the reasonableness of the CMP based on the erroneous assumption that its noncompliance did not cause or have the potential to cause serious harm. Furthermore, Petitioner asserts, incorrectly, that there is no evidence in the record that the increased dosage led to Resident #1's complications. P. Br. at 26. Petitioner overlooks the fact CMS established that:

•for 10 days, the facility committed a significant medication error by giving the resident 5 mg of Coumadin instead of 2.5 mg as was directed by the treating source;

•the facility had failed to properly monitor the administration of Coumadin before and during the time it incurred the medication error;

•when the nursing staff discovered the medication error on September 12, 2000, the DON was not promptly notified;

•Petitioner did not ensure that the physician associated with its facility assessed the resident's total program of care, including the federally mandated requirement to review the resident's medication regimen and treatment at each visit (See CMS Ex. 2, at 12, 13);

•that the combination of the medication error, lack of Coumadin therapy monitoring, and the failure of physician associated with the facility to properly assess the resident's total program of care resulted in Resident #1's Coumadin toxicity (See P. Br. at 14); and

•Resident #1's medical condition and medication regimen underwent no significant changes from September 1, 2000 through September 21, 2000, except for the changes associated with Coumadin administration and management of that medication and the fact that she began experiencing gastric problems as of September 13, 2003; ⁽²³⁾

•Coumadin is a narrow therapeutic range drug that if not carefully monitored can lead to many complications including stroke, hemorrhaging, permanent disability, and death;

•Resident #1 experienced hemorrhaging due to Coumadin toxicity and required hospitalization from September 1, 2000 through October 19, 2000.

Petitioner also relies on the case of Mediplex of Massachusetts, Inc., DAB CR584 (1999) for the proposition that a $5,000.00 a day CMP "for an isolated medication error" is punitive. ⁽²⁴⁾ P. Br. at 26. In Mediplex, says Petitioner, the ALJ reduced the CMP on a medication error that was repeated often over a period of days by multiple employees, calling it an isolated event.

Petitioner mischaracterizes the ALJ's findings in Mediplex. In that case the ALJ rejected Petitioner's argument that immediate jeopardy was inappropriate because there was absence of actual harm. In fact, the ALJ determined that misadministration of medications from April 1-22, 1998, constituted immediate jeopardy regardless of a showing by CMS of actual harm, and that the daily CMP of $7,000.00 imposed during that period was reasonable. Thus, a correct rendering of the Mediplex decision is no ally to Petitioner's arguments in the case before me.

Petitioner also complains that the CMP was higher than necessary because CMS failed to revisit the facility until six days after September 27, the day it alleged compliance. P. Br. at 27. However, since CMS reasonably determined that Petitioner was not in compliance as of September 27, this argument is baseless.

Finally, Petitioner argues that it was unfair for CMS to hold Petitioner liable at the immediate jeopardy level for the entire ten day period when Petitioner "corrected all the alleged deficiencies in full and had the majority of staff complete the in-service requirements prior to October 2. At the least, a reduction of the penalty from the immediate jeopardy level to a lower range of penalties is appropriate." P. Response at 21. This argument is not persuasive because Petitioner has not met its burden of showing that CMS's determination that the residents remained in immediate jeopardy until October 2 is "clearly erroneous." Clearly erroneous is a very high standard. ⁽²⁵⁾ In this case, Petitioner offered no testimony as to how its corrective actions over the period of September 22 to October 2 reduced the risk faced by its residents below the immediate jeopardy level. Without clear and convincing evidence on this question, I cannot find CMS's determination of continuing immediate jeopardy to be clearly erroneous.

In conclusion, inasmuch as Petitioner did not challenge any of the other factors considered by CMS in arriving at the CMP, the findings by CMS as to those issues remain uncontested. In the face of the severe deficiencies present in this case, it was reasonable to impose a $5,000.00 per day penalty for the period commencing September 21, 2000 and ending October 2, 2000. Such a penalty is appropriate, and within a reasonable range, given the circumstances of this case. I further find that it serves the purpose of encouraging return to compliance.

V. Conclusion

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that, from September 22, 2000 through October 1, 2000, Petitioner was not in substantial compliance at the immediate jeopardy level and that the imposition of a $5,000.00 per day CMP for that period is reasonable.

José A. Anglada

Administrative Law Judge

1. The Health Care Financing Administration has been renamed the Centers for Medicare & Medicaid Services (CMS). Reference to either name shall apply to both names.

2. The parties did not address the DPNA in their briefing or final statements of the issues; thus, I infer that CMS is only pursuing the imposition of a CMP based on immediate jeopardy.

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

4. Petitioner objects to CMS's reliance on the SOM on the grounds that it was not admitted into evidence nor testified to during the hearing. Further, Petitioner points out that the SOM does not carry the weight of law. P. Response at 13. However, the SOM is available to the public, is widely relied on in the nursing home industry, and sets forth a definition that is consistent with the ordinary and reasonable understanding of the words "significant medication error." Further, Petitioner did not offer an alternative definition.

5. Petitioner's expert, Dr. Ciccone, explained that such drugs potentiate the effect of Coumadin by creating "greater thinning of the blood than without them." Tr. at 259. He stated that Resident #1 was receiving several drugs that potentiate the effect of Coumadin including Prilosec, Zaroxylyn, Allopurinol, Ultram, Plavix (an anticoagulant), and Duragesic. P. Ex. 7, at 4-5.

6. Counsel also follows his discussion of this portion of Dr. Ciccone's testimony with a discussion of why the treating doctor's actions, after staff stopped the overdose, caused Resident #1 to be hospitalized with Coumadin toxicity. This discussion is irrelevant for purposes of this deficiency.

7. "It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. Coumadin, a narrow therapeutic range (index) drug, may be affected by such factors as other drugs and dietary Vitamin K." Physicians' Desk Reference 930 (53 ^rd ed. 1999).

8. In the Statement of Deficiencies (SOD), the surveyors mistakenly cited the applicable regulation as 42 C.F.R. § 483.20(d)(3)(i). CMS Ex. 2, at 2. At the hearing, the parties agreed that the correct citation for this deficiency is § 483.20(k)(3)(i). Tr. at 112. Petitioner was not prejudiced by this error because the narrative in the SOD referred to the "failure to meet professional standards of quality," the failure at issue in tag F281.

Petitioner does argue that this regulation should not be applied to the facts at issue because citations under § 483.20(k) should involve failures related to developing a comprehensive care plan and CMS did not allege any such failure. P. Br. at 16. This argument is misplaced. The plain language of § 483.20(k)(3)(i) requires that "services provided or arranged by the facility must . . . meet professional standards of quality." The Departmental Appeals Board (Board) has applied this standard to the actual provision of services by a facility, not just its care planning process. Georgian Court Nursing Center, DAB No. 1866 (2003); Emerald Oaks, DAB No. 1800 (2001).

9. For example, Petitioner's expert, Dr. Ciccone, testified he would have considered Resident #1's therapeutic range to be between 2.5 and 3.5. Tr. at 268. He also testified that, given her circumstances and medical history, he would recommend maintaining her at an INR between 3 and 3.5.id PT monitoring is therefore critical both because Coumadin's therapeutic range is now and the distance between an INR in a therapeutic range and an INR above a risk point can be narrow.

10. Dr. Elias wrote "PT twice weekly." CMS Ex. 13, at 5, 6. The standard direction for ordering PT/INR is to write "PT/INR." Tr. at 214, 262.

11. As stated by Dr. Gutierrez, elderly patients with congestive heart failure may be particularly more sensitive to the effects of Coumadin, requiring more frequent laboratory monitoring.

12. State surveyor, Alice Caldwell, testified that physical therapy is not ordered alone as suggested by Petitioner, but rather it is ordered with specifications as to what the desired goals are. That is the way the way the order was set forth at CMS Ex. 16, at 2. See also P. Ex 1, at 45.

13. The admission that laboratory testing was not performed on a daily basis is misplaced inasmuch as PT testing was ordered twice a week.

14. The weakness of this argument is highlighted by Petitioner's assertion that its "successful monitoring was evidenced by the fact that as soon as Resident #1 exhibited unusual signs of bleeding, she was immediately discharged to the hospital for follow-up care." P. Response at 7. However, the purpose of monitoring is to prevent a patient's reaching a stage at which they start hemorrhaging, not to simply notice when they begin hemorrhaging. This was not successful monitoring.

15. Further, Petitioner's characterization of its alleged noncompliance as resulting from an isolated transcription error ( P. Br. at 17, 19, and P. Response at 8, 10, 13, 19, 22) ignores the fact that it resulted in a medication error that occurred over a period of ten days, the fact that its staff failed to implement the doctor's order for PT testing, and the fact that its staff failed to report a significant medication error as required by its own policies.

16. Of course, monitoring of Coumadin therapy is crucial in every instance, but it was exceedingly critical in the case of Resident #1.

17. It is incorrect to refer to an INR value as being normal. Since Coumadin therapy has to be individualized, it is more proper to speak of therapeutic range. Tr. at 150.

18. Coumadin is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Physicians' Desk Reference 930 (53 ^rd ed. 1999).

19. The August 8, 2000 PT test result that appears in the record is an isolated reference to a lab result within a two and half month period. It is suspect in that it is lacking in documentary support to justify its reliability. Tr. at 166, 167.

20. Petitioner seeks to diminish the role of the Coumadin toxicity in Resident #1's hospitalization and her extended stay (September 21 to October 19). See Tr. at 278-279. Whether Resident #1 had other problems unrelated to her Coumadin toxicity is not relevant to my conclusion that she did suffer Coumadin toxicity.

21. Petitioner cites Corleto v. Shore Memorial Hospital, 138 N.J. Super. 304 (Law Div. 1975) for the proposition that a hospital is not liable for the negligence of a doctor who is not a hospital employee. P. Br. at 15. Petitioner recognizes that Corleto involved a hospital rather than a nursing home but argues "an analogy can be drawn to a nursing home as well." Id. I reject this argument. As discussed above, the Act places on a nursing facility an independent obligation to plan for and provide services to meet the medical needs of each resident to help each resident maintain the highest practicable physical well-being. Section 1819(b)(2) of the Act; Beverley Health and Rehab-Springhill, DAB No. 1696, at 44 (1999). Consequently, even if an outside doctor harms a resident, a nursing facility cannot avoid responsibility for its noncompliance when its noncompliance contributed to that harm.

22. As Dr. Ciccone explained, when a patient's clotting factors are low, as Resident #1's were by September 13, "the ability to make it [the INR] go even higher is easier . . . . So the ability to go to a higher range is - you need less dosage." He stated "Because as you get Coumadin . . . you need less and less as you get higher and higher. So you may need five milligrams to get to 3.3 and 4.2, but when you're there you don't need five milligrams, you don't need 2.5, you need zero." Tr. at 296. Thus, according to Dr. Ciccone, the fact that Dr. Elias only administered 2.5 mg on September 13, 14, 15 and 18, plus the fact that Resident #1 had started vomiting and having diarrhea, was sufficient to send her INR off the charts. Tr. at 290-291. However, I note that Resident #1 had been receiving 2.5 mg of Coumadin since at least June without adverse effect. Therefore, but for the medication error, Dr. Elias' continued administration of 2.5 mg Coumadin on September 13, 14, 15 and 18 should not have caused Resident #1 to experience Coumadin toxicity by September 20. Tr. at 245.

23. The experts disagreed as to whether her nausea was related to the overdose of Coumadin. The medical literature recognizes nausea as an infrequently reported adverse reaction (CMS Ex. 28, at 14) and Dr. Gutierrez testified the nausea could have been a side effect. Tr. at 183. Dr. Ciccone acknowledged that nausea could be a side effect but said he did not believe it was in this case. Tr. at 277, 279, 299.

24. This case was cited by Petitioner merely as Mediplex, without further specification.

25. A finding is clearly erroneous when "although there is evidence to support it, the reviewing court on the entire evidence is left with the definite and firm conviction that a mistake has been committed" (United States v. United States Gypsum Co., 333 U.S. 364, 395 (1948)) or when a finding is "unsupported by substantial evidence, contrary to the clear weight of the evidence, or induced by an erroneous view of the law." Gasifier Mfg. Co. v. General Motors Corporation, 138 F.2d 197, 199 (8th Cir. 1943).