SUBJECT:

Britthaven of Smithfield,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) against Britthaven of Smithfield (Petitioner) for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and State Medicaid programs. The CMP of $200 per day for the period which ran from September 11, 2002 through December 10, 2002, is, however, reduced to $150 per day.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner on December 9, 2002, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g), 498.40.

Petitioner is a skilled nursing facility located in Smithfield, North Carolina. On September 11, 2002, a standard survey was conducted at Britthaven of Smithfield by the North Carolina State Survey Agency (State agency). The survey found that Petitioner was not in substantial compliance with participation requirements. On October 11, 2002, CMS informed Petitioner that, based on survey findings, it was imposing the following remedies:

�CMP of $200 per day, effective September 11, 2002;

�Mandatory Denial of Payment for New Admissions (DPNA), effective December 11, 2002, and;

�Mandatory Termination, effective March 11, 2003.

CMS concedes that Petitioner returned to substantial compliance on December 10, 2002, thereby removing the recommended remedies of termination of Petitioner's provider agreement and the DPNA. Therefore, the only issue before me is the imposition of the CMP.

The parties have agreed to waive their right to an in-person hearing and have the case decided on the basis of documentary evidence and written memoranda. Petitioner's Brief (P. Br.) at 2; CMS Brief (CMS Br.) at 2. CMS submitted 40 exhibits. These have been admitted into the record, without objection, as CMS Exhibits (CMS Exs.) 1 - 40. ⁽¹⁾ Petitioner proffered 21 exhibits. These have been admitted into the record, without objection, as Petitioner's Exhibits (P. Exs.) 1 - 21. Each party also filed a response brief.

Based on the documentary evidence, affidavits, the written arguments of the parties, and the applicable law and regulations, I find that from September 11, 2002 through December 10, 2002, Petitioner was not in substantial compliance with Medicare participation requirements. Accordingly, I sustain the imposition of the CMP, but reduce the CMP to $150 per day.

II. Applicable Law and Regulations

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

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs and DPNAs 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. Title 42, Code of Federal Regulations (42 C.F.R.), Part 488, provides that facilities which participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. �� 488.10 - 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 specify that a CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMPs, from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1), (d)(2). The lower range of CMPs, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(2).

The regulations, at 42 C.F.R. � 488.301, 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.

Substandard quality of care, as defined at 42 C.F.R. � 488.301, means:

one or more deficiencies related to participation requirements under 42 C.F.R. � 483.13, Resident behavior and facility practices, section 483.15, Quality of life, or section 483.25, Quality of care . . . which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm that is not immediate jeopardy, or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm.

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 noncompliance, including repeated deficiencies;

2. The facility's financial condition;

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

4. The facility's degree of culpability.

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

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

III. Issues

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

B. 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 bold and italics are followed by a discussion of each finding.

A. The facility did not fail to immediately consult with the resident's physician when there was a significant change in the condition of two of 30 sampled residents (Residents #1 and #27). State surveyor findings for Tag F157.

The regulations at 42 C.F.R. � 483.10(b)(11) provide, in relevant part, that a facility must immediately consult with the resident's physician when there is:

�an accident involving the resident which results in injury and has the potential for requiring physician intervention;

�a significant change in the resident's physical, mental, or psychosocial status; or

�a need to alter treatment significantly.

Resident #1

The Statement of Deficiencies (SOD) reveals that Resident #1 (R1) was admitted to the facility on January 21, 2002, with diagnoses that included profound dementia, history of steel syndrome in the left hand, diabetes, peripheral vascular disease, and left ischemic hand with status post splint thickness graft.

On August 16, 2002, the facility notified R1's physician that R1 exhibited an abrasion to her left index finger with an indication that she was chewing that finger. The facility applied dressings and mittens as an intervention to prevent further injury. However, the resident would remove the dressings and mittens using her teeth. The re-application of the interventions did not prevent the resident from chewing her finger which, at all times, was described by facility records as an abrasion.

By September 9, 2002, R1 had reduced her left index finger down to the first joint by continuous chewing. At that time, she was taken to the hospital emergency room. The treating physician was notified on September 11, 2002. CMS Ex. 1, at 1-4.

Petitioner contends that upon learning that R1 was biting and chewing on her left index finger, immediate notification was made to her physician, and that no other significant change occurred over the next three and a half weeks. Nonetheless, adds Petitioner, throughout that period the facility repeatedly contacted the treating physician and made him aware of the resident's continuing behavior. P. Br. at 4; P. Ex. 18, at 1-2.

Petitioner's Exhibit 18 is the affidavit of Elizabeth James, a Britthaven, Inc., consultant. In her declaration, she states that although the treatment records document that the physician was notified on August 16, 2002, it is clear that he was regularly and appropriately notified of the resident's continuing mutilating behavior. P. Ex. 18, at 1.

In this regard, the record reflects that on August 23, 2002, there was facility contact with the treating physician that resulted in an order for mitten restraints on both hands "to prevent further self injury to left index finger and to promote healing." P. Ex. 1. It is further noted that pursuant to a suggestion by a family member that R1 might have been biting her finger due to hunger, a dysphagia work up was completed on August 28, 2002. P. Ex. 6, at 7, 30. As a result of that study, the treating physician ordered pleasure feedings that included puree with honey and thickened liquids. P. Ex. 6, at 30, 32.

CMS counters Petitioner's alleged initiatives mentioned above, with the indication that there is no evidence as to who contacted the physician. Furthermore, CMS maintains that even if staff other than the treatment nurse informed the physician that the resident was continuing to bite her finger, such notification was insufficient to convey the message of a "significant change." CMS Response Brief at 8. In this context, CMS defines significant change as the resident's act of chewing away her finger to the point of amputation.

CMS's arguments are not supported by the applicable regulatory criteria, nor by the evidence of record. I note that the regulation at 42 C.F.R. � 483.10(b)(11)(B) mandates that a facility must immediately consult with the resident's physician when there is a significant change in the resident's physical, mental, or psychosocial status. The regulation does not designate a particular individual as the person required to make notification. Thus, CMS's argument that notification by "other staff" is insufficient is misplaced. Additionally, the regulation attaches no unique significance to the manner in which the notification is conveyed.

From the record, it appears that it was not until September 9, 2002, that the resident chewed her left index finger to the point of partial amputation. At that time, the physician and family were notified. However, the record also reflects that between the initial notification of August 16, 2002, and the notification of September 9, 2002, the physician was notified of the need for additional measures to protect the resident. As stated earlier, on August 23, 2003, the physician issued an order for mittens on both hands "to prevent further self injury to the left index finger and to promote healing." P. Ex. 1. It is evident that the physician's order addressing the resident's self injury to her left index finger was based on a sufficient notice regarding the need for additional interventions to protect the resident. The record also shows that prior to September 9, 2002, based on a family request, the treating physician ordered pleasure foods for R1. P. Ex. 6, at 30. The family had theorized that the resident may have been biting her finger because she was hungry. CMS Ex. 3, at 19. ⁽²⁾

Resident #27

According to the SOD, Resident #27 (R27) was re-admitted to the facility on June 20, 2002, with multiple diagnoses that included myocardial infarction and atherosclerotic heart disease. On August 27, 2002, at 1:20 p.m., she complained of nausea and dry heaves. The nurse's notes described her skin as bright red in color and diaphoretic. She also complained of being hot and feeling very sick.

The SOD also discloses that an attempt to notify the treating physician failed and a message was left with the receptionist. After that attempt, no follow up call was made by facility staff to the physician for a period of eight hours. CMS Ex. 1, at 4-5.

Petitioner contends that the facility immediately notified the treating physician regarding the change in R27's condition and obtained a standing order for Mylanta within an hour of the onset of the resident's condition. Petitioner adds that the administration of Mylanta resulted in temporary relief, and that new physician orders were obtained when the resident renewed her complaints. P. Br. at 9. The record supports Petitioner's contention.

The nurse's notes reflect that on August 27, 2002, at 1:20 p.m., the charge nurse attempted to reach Dr. Barton to inform him of the change in R27's status, but was un-successful. Within the hour, however, Dr. Creek, who was on call for Dr. Barton, responded with a standing order for Mylanta, which was administered with good results at 2:30 p.m. CMS Ex. 4, at 4, 8. At 9:30 p.m., when the resident complained of generalized discomfort and lack of mobility in lower extremities, Dr. Creek was again contacted and he ordered milk of magnesia and a lab work-up. Id. The record also reflects that the facility continued to monitor the resident's condition on an ongoing basis until she expired at 2:45 a.m. on August 28, 2002. CMS Ex. 4, at 5.

In view of the foregoing, I conclude that Petitioner has overcome CMS's prima facie case under Tag F157 by a preponderance of the evidence. I find that the facility did not fail to notify the physician immediately after a significant change in the physical, mental, or psychosocial status of R1 and R27.

B. The facility, as alleged in the SOD, failed to provide services that met professional standards of quality (Tag F281).

The applicable regulation at 42 C.F.R. � 483.20(k)(3)(I) provides:

The services provided or arranged by the facility must meet professional standards of quality.

Based on record review and staff interviews, the facility failed to follow physician orders for medications and/or laboratory studies for 15 of 35 sampled residents (Residents 3, 6, 8, 10, 12, 13, 14, 15, 18, 23, 26, 27, 28, 35, and 36). The specific findings relative to these deficiencies are outlined in the SOD, CMS Exs. 5-12, and are hereby incorporated by reference.

Petitioner concedes that as of September 11, 2002, its facility had "issues involving the transcript of orders onto the medication administration records and that the system in place for following up on lab orders and tests needed improvement." However, argues Petitioner, the facility worked diligently and efficiently to resolve all issues by the date indicated on its plan of correction dated October 18, 2002 and accepted by the State survey agency. Thus, asserts Petitioner, CMS's conclusion that the violation persisted until December 10, 2002, is due to the untimeliness of the revisit conducted by the State. P. Br. at 9-10.

When CMS determines that a long term care facility is in violation of federal participation requirements, it may impose a CMP that starts 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. Substantial compliance is achieved when the State surveyors find that no other incidents like the ones at issue giving rise to the imposition of remedies are present and the facility has implemented a plan of correction designed to assure that no such incidents will occur in the future.

In the instant case, CMS offered the written declaration of John Moore, a Team Coordinator employed by the Licensure and Certification Section of the Division of Facility Services, North Carolina Department of Health and Human Services. Mr. Moore noted in his statement that the review of the violation under Tag F281, which was for wide-spread failure to provide services that met professional standards of quality, showed that the facility did not establish that this Tag was removed prior to the date of the revisit. Because of the numerous examples of that deficiency in the initial survey, the surveyors had to undertake a comprehensive review to determine whether the deficiency was removed. Mr. Moore added that on the December 12, 2002 revisit, a surveyor observed that a medicine cart was left unattended in the hallway for several minutes. This had the potential to cause more than minimal harm. After discussing that issue with the facility, the surveyors were given assurance that the problem would not recur. CMS Ex. 37, at 5, 6. The regulations do not require that CMS include in the SOD specific incidents occurring after September 11, 2002 involving a regulatory violation with which the facility was found out of compliance. The regulations carry the presumption that the problems giving rise to the imposition of remedies continued until the facility implemented a plan of correction designed to prevent their recurrence. In this regard, it must be pointed out that no legal mandate binds state survey agencies to time lines in the conduct of revisits.

The governing factor in this process is a state survey agency's assurance that the deficiencies have been corrected and that the facility has implemented measures in order to protect residents from similar deficiencies in the future. It does not suffice that the facility has conceived a plan of correction to address the deficiencies. The state agency must ascertain that the proposed corrective action is viable and that, where appropriate, each affected resident's care plan reflects the corrective initiatives.

This issue was amply addressed in Barn Hill Care Center, DAB No. 1848 (2002). The Departmental Appeals Board's (Board) language in that case is dispositive of the argument raised by Petitioner regarding the alleged untimeliness of the State agency's revisit survey of December 12, 2002. The Board stated the following:

This discussion correctly focuses on substantiation of the initial finding that the facility was not in substantial compliance and assessment of whether its correction efforts had resulted in reestablishing substantial compliance. On appeal, Barn Hill argued . . . that CMS must assert and prove that Barn Hill was noncompliant on the days for which it actually imposed the CMP.

Barn Hill, DAB No. 1848, at 12-13 (quoting Barn Hill Care Center, DAB CR902, at 21-22 (2002)); see also Coquina Center, DAB No. 1860 (2002); Regency Gardens Nursing Center, DAB No. 1858 (2002); Lake City Extended Care, DAB No. 1858 (1998).

The Board rejected that argument, relying on the regulatory scheme and citing the following analysis from a prior case:

That scheme does not require that CMS provide affirmative evidence of continuing noncompliance, nor does it require that the surveyors identify the underlying problems giving rise to a deficiency finding as well as its factual basis. Instead, under the regulatory scheme, where there is a deficiency involving a potential for more than minimal harm, the facility must submit a plan of correction which describes: 1. How corrective action will be accomplished for those residents found to have been affected by the deficient practice; 2. How the facility will identify other residents having the potential to be affected by the same deficient practice; 3. What measures will be put into place or systemic changes made to ensure that the deficient practice is being corrected and will not recur, i.e., what program will be put into place to monitor the continued effectiveness of the systemic changes.

Barn Hill, DAB No. 1848, at 14 (quoting Lake City, DAB No. 1858, at 12-13).

Even if the plan of correction is accepted, the facility is not regarded as in substantial compliance until CMS determines, usually through a revisit survey, that the deficiency no longer exists. 42 C.F.R. � 488.440(b) and (h); see also 42 C.F.R. �� 488.401 (definition of "plan of correction"), 488.402(d) and 488.408(f)(1).

In view of the above discussion I find that CMS has established a prima facie case as to the existence of deficiencies under Tag F281 through December 10, 2002. Petitioner has not overcome that finding by a preponderance of the evidence.

C. The facility failed to provide R1 adequate supervision and assistance devices to prevent accidents. Petitioner's lack of appropriate intervention allowed the resident to suffer partial loss of her left index finger through self mutilation (Tag F324)

The applicable regulation at 42 C.F.R. � 483.25(h)(2), entitled "Quality of care" provides:

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

The facts regarding this deficiency are the same as set forth in Finding A, above. As pertinent here, those facts are summarized as follows: On August 16, 2002, the facility documented that R1 exhibited an abrasion to her left index finger with an indication that she was chewing that finger. The facility applied dressings and mittens as an intervention to prevent further injury. However, the resident would remove the dressings and mittens using her teeth. The re-application of the interventions did not prevent the resident from chewing her finger. By September 9, 2002, R1 had reduced her left index finger down to the first joint by continuous chewing. At that time, she was taken to the hospital emergency room. CMS Ex. 1, at 13-17. I have already concluded that Petitioner was in substantial compliance with the requirement to notify the physician immediately after a significant change in the physical, mental, or psychosocial status of R1 and R27. However, for the reasons stated below, I find that Petitioner failed to provide R1 adequate supervision and assistance devices to prevent accidents. These violations are not mutually exclusive.

Petitioner contends that its facility brought to bear frequent and constant monitoring of R1, and that the staff continuously updated and amended the interventions. Specifically, Petitioner maintains that the interventions went from gauze to a single mitten, to double mittens, to wrist restraints, to replacing the gauze multiple times per day, to recommending psychiatric evaluation and adding Risperdal to her medication regimen. Petitioner's Response Br. at 5.

The nurse's notes reflect that on August 15, 2002, R1 bit her left index finger. The affected area was cleansed and a band aid was applied. P. Ex. 6, at 7. The following day the treating physician was notified (P. Ex. 18, at 1) and, on August 23, 2002, he ordered mittens for the resident to prevent further self injury to her left index finger and to promote her healing. P. Ex. 19. On August 19, 2002, however, prior to the physician's order, the facility had already provided the resident with gauze wrapping to her left index finger and a mitten to her left hand. P. Ex. 6, at 9. That same day, the resident removed the mitten and unwrapped the gauze from her left index finger. The following day R1 was fitted with a mitten on her right hand also. The nurse's notes reveal that R1 continued to remove the mittens with her teeth and chew on her left index finger. During the period from August 19, 2002, until September 9, 2002, when she was taken to the hospital emergency room, R1 repeatedly chewed on her finger, and the facility merely replaced the mittens. P. Ex. 6, at 9, 10. During this three week period no changes were made to the intervention in order to obtain better results.

On August 20, 2002, a family representative of R1 suggested that she might be biting her finger because she was hungry. P. Ex. 6, at 7. The facility's response to the suggestion was to obtain a dysphasia evaluation that was conducted from August 28, 2002 until September 11, 2002, and resulted in the administration of pleasure foods. P. Ex. 6, at 28. However, when the resident was first fed pleasure foods is uncertain. The nurse's notes dated August 29, 2002, mention a "new pleasure food order" without specifying the meaning of the phrase. P. Ex. 6, at 9. Therapy daily progress notes show that the dietary order for pleasure foods was completed, but again there is no clear indication that the intervention was implemented. Those notes do reveal that the resident was fed by mouth on the 5^th and 6^th of September 2002. P. Ex. 5, at 32. The Dysphasia Discharge Summary dated September 11, 2002, indicates that at the time of that evaluation the resident was receiving pleasure foods by mouth, but it failed to state the date when such feedings began. P. Ex. 6, at 29. Even under the assumption that pleasure feedings began on August 29, 2002, such a response was inadequate in the management of a situation that called for a greater measure of aggressiveness. Under the circumstances of this case, where the resident was chewing on her finger daily, and the replacement of the gauze and mittens had already proved to be a failed attempt at deterring self mutilation, more than a week's delay in putting in place another intervention was clearly inadequate.

Petitioner also alleges that it implemented an intervention consisting of a psychological evaluation. The referral was made to the psychologist on August 27, 2002. However, the physician did not sign-off on the recommendation until August 31, 2002, and the family did not give their consent until September 2, 2002. Petitioner further maintains that the appointment for the evaluation was made immediately thereafter. Petitioner's Response Br. at 5; CMS Ex. 3, at 33. The facility records, however, reveal that it was not until September 11, 2002, that the social worker contacted the mental health center in order to arrange for a consultation. Nine days subsequent to obtaining family consent to perform a psychological evaluation cannot be considered to be "immediate action." P. Ex. 9, at 26. From the time the resident began to chew on the mittens and remove the gauze from her fingers, until the psychological evaluation of September 11, 2002, much transpired. Pertinent to this is the fact that on September 9, 2002, the resident was taken to the hospital emergency room exhibiting an amputated left index finger resulting from self mutilation.

The family also requested that the facility employ a restraint in order to prevent the resident from biting her finger off. CMS Ex. 3, at 20. The only inference that I can draw from this request is that the daughter had grown impatient with the ineffectiveness of the mittens that R1 had been continuously taking off since August 19, 2002. Although the request for some other kind of restraint was made on September 1, 2002, there is no evidence of implementation prior to September 9, 2002, by which time the resident had bitten her left index finger down to the first joint. The facility assumed a lackadaisical attitude in regard to R1's obsession with chewing on her finger. This is evident from its reference to the ongoing self mutilation of the resident's left index finger as a mere abrasion. P. Ex. 6, at 11, 12.

It should also be noted that, contrary to Dr. David Jackson's assertion, CMS need not show that any of the possible interventions discussed above would have guaranteed a positive outcome. P. Ex. 5, at 3. What CMS needs to establish, and what is evident in this case, is that Petitioner did not aggressively pursue implementation of those interventions that its facility conceived as appropriate or that it adopted upon family request. Additionally, the facility did not modify its failed implementation of protective mittens in spite of their daily removal by the resident and her continued chewing of the finger. Although the facility monitored the application of that intervention, such supervision was inadequate because no prompt and corrective action was taken in the face of its failure.

In view of the foregoing, I find that the facility failed to provide R1 adequate supervision and assistance devices to prevent accidents. CMS has established a prima facie case that Petitioner's lack of appropriate intervention allowed the resident to suffer partial loss of her left index finger through self mutilation. Petitioner has not overcome that showing by a preponderance of the evidence.

D. The facility failed to ensure that it was free from medication error rates of five percent or greater (Tag F332).

The applicable regulation at 42 C.F.R. � 483.25(m)(1) under "Quality of care" provides:

The facility must ensure that it is free of medication error rates of five percent or greater.

Based on observation, record review, and staff interview, the facility failed to ensure that it was free from medication error rates of five percent or greater. The facility's calculated medication error rate was 6.25% (3 errors out of 48 opportunities for error) and was based on an improper technique in administering three respiratory inhalers for Residents 32, 33, and 34. These residents had orders to receive a Combivent inhaler 2 puffs, four times a day. The medication administration record revealed the need to wait one minute between puffs. Observation of the medication pass on September 9, 2002, revealed that these residents were administered the inhaler and the staff waited approximately three seconds between each puff instead of one minute. CMS Ex. 1, at 15-16.

Petitioner contends that CMS has presented no evidence that the error observed, failure to wait one minute between puffs of a Combivent inhaler, had the potential to cause more than minimal harm. I disagree.

The surveyor's observations, as stated in the SOD, suffice to establish a prima facie case of lack of substantial compliance. Therefore, Petitioner's general denial fails to rebut CMS's showing by a preponderance of the evidence. Moreover, CMS offered the affidavit of Wiley Leon Whitehead, pharmacy consultant of the North Carolina Department of Health and Human Services, in support of its charge that Petitioner failed to comply with the requirements under Tag F332. It is Mr. Whitehead's declaration that waiting one minute between puffs allows the second puff to be more effective. This is so because, if the first puff is given a chance to work, the second puff can get deeper into the patient's lungs, which should allow the medication to work more effectively. Clearly, the facility did not provide Residents 32, 33, and 34 the necessary care and services to attain the highest practicable physical, mental, and psychosocial well-being in accordance with the comprehensive assessment and plan of care. That failure had the potential to cause more than minimal harm

E. The facility's pharmacist failed to report noted irregularities to the attending physician and the director of nursing (Tag F429).

The applicable regulation at 42 C.F.R. � 483.60(c)(2) requires that the pharmacist report any irregularities to the attending physician and the director of nursing.

Based on record review and staff interview, the facility's pharmacist failed to report noted irregularities to the attending physician and the director of nursing. CMS Ex. 1, at 16-17.

The facility has not come forward with evidence to contradict CMS's showing of lack of substantial compliance. As a result, it has failed to meet its burden of overcoming CMS's prima facie case by a preponderance of the evidence.

F. A basis exists to impose remedies against Petitioner for deficiencies that are at the less than immediate jeopardy level of noncompliance.

In view of the foregoing discussion under each Tag, I conclude that CMS satisfied the criteria for imposing remedies at the less than immediate jeopardy level. First, CMS established a prima facie case, which Petitioner did not rebut, that, as of September 11, 2002, it was not complying substantially with participation requirements. Second, Petitioner did not show it had eliminated the noncompliance on any date prior to December 10, 2002. Thus, I find that CMS may impose a CMP in the range of from $50 to $3,000 per day, beginning on September 11, 2002 and ending December 10, 2002.

CMS imposed a $200 per day CMP for the period beginning on September 11, 2002 and ending on December 10, 2002. In view of the severity of the deficiencies and culpability of the facility, I sustain CMS's imposition of a penalty, but reduce the amount to $150 per day. A penalty of $150 is in the lower range of penalties which may be imposed for deficiencies that are at the less than the immediate jeopardy level of noncompliance. 42 C.F.R � 488.438(a)(1)(ii). The beginning date of the penalty is the date that CMS first determined Petitioner not to be complying substantially with participation requirements at the less than immediate jeopardy level. 42 C.F.R. � 488.440(a).

CMS had established a CMP of $200 per day based on deficiencies included in five different Tags. As discussed earlier, however, Petitioner has overcome CMS's prima facie case under Tag F157 by a preponderance of the evidence. Thus, I conclude that a reduction of the CMP to $150 is reasonable on that basis. I note also that Petitioner has not taken issue with the factors taken into account by CMS in establishing the amount of the CMP. ALJ Ex. 1, at 2.

V. Conclusion

I conclude that, except for the survey findings at Tag F157, beginning September 11, 2002 and continuing through December 10, 2002, Petitioner was not complying substantially with federal requirements governing participation of long term care facilities in Medicare and State Medicaid programs at the less than immediate jeopardy level, and I conclude that the imposition of a CMP of $150 per day is reasonable.

José A. Anglada

Administrative Law Judge

1. Inasmuch as CMS mentioned the Notice of Remedies in its brief, but failed to include it as an exhibit, I have entered a copy of that letter motu proprio and marked it as ALJ Ex. 1. See CMS Br. at 2.

2. It should be noted that R1 was out of the facility from August 20, 2002 until August 24, 2002, for dialysis. CMS Ex. 3, at 20.