SUBJECT:

Paducah Center for Health and Rehabilitation,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Paducah Center for Health and Rehabilitation (Petitioner) was not in substantial compliance with 42 C.F.R. � 483.25 (Tag F 309) at the immediate jeopardy level from November 2, 2001 through November 15, 2001. Petitioner was in substantial compliance with 42 C.F.R. � 483.25(h)(2) (Tag F 324), and the Centers for Medicare & Medicaid (CMS) determination to the contrary was clearly erroneous. There is a basis for the imposition of a civil money penalty (CMP) for a deficiency at the immediate jeopardy level. The CMP imposed by CMS was erroneously based upon two immediate jeopardy deficiencies rather than one and it is unreasonable. A CMP in the amount of $3,050 per day for the period November 2, 2001 through November 15, 2001 is reasonable. ⁽¹⁾

I. PROCEDURAL HISTORY

Petitioner is a long-term care facility participating in the federal Medicare program as a skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility (NF). Petitioner is located in Paducah, Kentucky. The Kentucky Cabinet for Health Services, Office of Inspector General, Division of Long Term Care (the State agency) conducted a recertification survey from October 29, 2001 through November 2, 2001, at Petitioner's facility and prepared a statement of deficiencies (SOD), dated November 2, 2001. The survey team determined that Petitioner was not in substantial compliance with multiple regulatory requirements, two of which were found to be at the level of immediate jeopardy. ⁽²⁾ Petitioner requested a hearing on only the two immediate jeopardy findings: 42 C.F.R. �� 483.25 (Tag F 309) and 483.25(h)(2) (Tag F 324), both related to quality of care.

Petitioner was notified by letter from CMS dated November 9, 2001 that, based on the survey which ended on November 2, 2001, CMS was imposing a denial of payment for new Medicare and Medicaid admissions (DPNA) effective November 11, 2001; a CMP of $4,050 per day effective November 2, 2001 until the removal of the immediate jeopardy or until termination of Petitioner; and mandatory termination on November 25, 2001. CMS also notified Petitioner that the amount of the CMP could be reduced if the immediate jeopardy was removed but noncompliance continued. CMS Exhibit (CMS Ex.) 2.

The State agency conducted a revisit of Petitioner's facility on November 14, 2001 and determined that as of the revisit date Petitioner had not removed the immediate jeopardy. Petitioner's facility was again revisited on November 20, and it was determined that immediate jeopardy was removed on November 15, but substantial noncompliance continued. Petitioner was notified by letter dated November 28, 2001 of CMS's revised remedies: CMP of $4,050 per day from November 2 through November 15, 2001; CMP of $500 per day from November 16, 2001 until substantial compliance achieved; DPNA, effective November 26, 2001; termination of provider agreement on May 2, 2002. CMS Ex. 6. A revisit survey on December 18, 2001 confirmed that Petitioner achieved substantial compliance on December 14, 2001. CMS cancelled the denial of payment for new admissions and the termination action. The $500 per day CMP ended on December 13, 2001, the day before substantial compliance was achieved. CMS Ex. 10.

Petitioner requested a hearing by letter dated January 4, 2002. The case was assigned to me for hearing and decision on January 28, 2002. I conducted a hearing in this case, from December 3 through December 4, 2002, in Hopkinsville, Kentucky. A 326-page transcript was prepared and reviewed by the Parties. During the hearing, CMS offered and I admitted into evidence CMS exhibits 1 through 16. Transcript page (Tr.) 15. Petitioner offered and I admitted into evidence Petitioner's exhibits (Exs.) 1 through 39. Tr. 27-28 and 216. CMS called two witnesses, State surveyors Susan Faye Green and Cheryl White. Petitioner called four witnesses, Wendell E. Gordon, M.D., the physician for both residents at issue; Cindy Buckhalter, a licensed practical nurse (LPN) and floor supervisor at Petitioner's facility; Melissa Halstead, a registered nurse and staff development coordinator during the relevant time period; and Jeannie Downs, a speech pathologist at Petitioner's facility. ⁽³⁾ The Parties were directed to file post hearing briefs and reply briefs. All post hearing briefs were timely filed.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

1. Petitioner's facility, located in Paducah, Kentucky, participates in the federal Medicare program and the State of Kentucky Medicaid program.

2. The State agency conducted an annual survey of Petitioner's facility from October 29 through November 2, 2001.

3. At the conclusion of the survey, on November 2, 2001, the State agency prepared a SOD bearing that same date.

4. The State agency alleged that Petitioner violated 42 C.F.R. �� 483.25 (Tag F 309) and 483.25(h)(2) (Tag F 324), related to quality of care, with respect to Residents 17 and 14, respectively.

5. The State agency concluded that Petitioner's violations represented "immediate jeopardy" deficiencies as that term is defined under 42 C.F.R. � 488.301.

6. On November 14, 2001, the State agency conducted a revisit of Petitioner's facility and determined that Petitioner had not removed the immediate jeopardy as of the revisit date.

7. On November 20, 2001, the State agency conducted a second revisit and determined that immediate jeopardy was removed on November 15, but that Petitioner was not in substantial compliance.

8. A third revisit, on December 18, 2001, found Petitioner to be in substantial compliance as of December 14, 2001.

9. Ultimately, CMS notified Petitioner of the alleged violations and that CMS intended to impose a CMP of $4,050 per day from November 2 through November 15, 2001, and a $500 per day CMP from November 16 through December 13, 2001.

10. Resident 17, a male, approximately 79 years old, was admitted to Petitioner's facility on October 13, 2001, with the following diagnoses pertinent to this case: dementia, hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), ⁽⁴⁾ and cerebral vascular accident.

11. Resident 17's Minimum Data Set was required to be completed by October 27, 2001, and his Comprehensive Plan of Care was required to be completed by November 3, 2001.

12. The admission orders for Resident 17 included the daily administration of Lasix 40 mg., Prinivil 10 mg., Lanoxin 0.25 mg., and the administration of oxygen at 2 liters per minute for pulse oximetry less than 90 percent.

13. On October 14, 19, and 22, 2001, a facility nurse withheld Resident 17's blood pressure medication without a physician's order and did not notify the physician that the medication was withheld or that the resident experienced low blood pressure readings.

14. Petitioner did not provide documentation that it performed the ordered pulse oximetry prior to administering oxygen or discontinuing oxygen.

15. Resident 17 was transported to a hospital emergency room on October 29, 2001, where he was admitted to critical care and was treated for severe dehydration, severe COPD, and hypotension.

16. Resident 17 died on November 7, 2001.

17. Resident 14 was admitted to Petitioner's facility on July 13, 2001, with diagnoses including multi-infarct dementia, dysphagia, and coronary heart disease.

18. Resident 14's son was authorized to make health care decisions for Resident 14.

19. On admission, Resident 14's physician ordered a pureed diet with thickened liquids for Resident 14.

20. Resident 14 was screened by Petitioner's speech pathologist and received therapy during the period July 2001 to September 2001.

21. Resident 14's son and wife had been trained to feed the resident and were counseled on the dangers of feeding the resident foods that were not part of his therapeutic diet.

22. Resident 14's son and/or wife were often present during one or more meals a day and often fed the resident.

23. Resident 14's diet was changed on August 1, 2001 to mechanical soft with ground meats and nectar thickened liquids.

24. Notes in Resident 14's medical records indicate that Resident 14 experienced episodes of coughing and choking on September 11 and 13, 2001.

25. On September 13, 2001, Resident 14's diet was again downgraded to pureed consistency with honey thickened liquids from mechanical soft.

26. On September 14 2001, Resident 14's son demanded that Resident 14's diet be change back to mechanical soft foods.

27. Resident 14's physician authorized the change in diet requested by Resident 14's son because the family had been counseled, and he believed that the family was aware of the potential risks of choking and/or aspiration.

28. On September 15, 2001, Resident 14 was admitted to a local hospital and subsequently died.

29. Resident 14's cause of death was listed on the death certificate as "aspiration of food bolus" and in the coroner's investigative report as "cardiorespiratory arrest due to aspiration of bolus."

B. CONCLUSIONS OF LAW

1. Petitioner timely requested a hearing.

2. Pursuant to 42 C.F.R. � 483.25, each resident of a facility, such as Petitioner's, must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care.

3. CMS made a prima facie showing that Petitioner failed to provide the necessary health care and services to Resident 17 based upon Petitioner's failure to adhere to the resident's care plan and physician's orders, and to notify the physician of the resident's low blood pressure readings.

4. Pursuant to 42 C.F.R. � 483.25(h)(2), a facility, such as Petitioner's, must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

5. The preponderance of the evidence is that Petitioner complied with the requirement of 42 C.F.R. � 483.25(h)(2) to prevent accidents and provided reasonable supervision with respect to Resident 14's diet and feeding.

6. The CMS determination that there was immediate jeopardy with respect to the violation of 42 C.F.R. � 483.25 (Tag F 309) was not clearly erroneous.

7. A CMP in the amount of $4,050 is unreasonable but a CMP of $3,050 is reasonable based on the one immediate jeopardy finding in this case.

III. DISCUSSION

A. ISSUES

The issues in this case are:

1. Whether Petitioner was in substantial compliance with the requirements of participation set forth in 42 C.F.R. �� 483.25, Tag F 309, and 483.25(h)(2), Tag F 324, during the period November 2, 2001 through November 15, 2001;

2. Whether either of the two deficiencies at issue in this appeal constituted immediate jeopardy to resident health and safety and substandard quality of care ⁽⁵⁾ as those terms are defined in 42 C.F.R. � 488.301; and

3. Whether the CMP imposed by CMS was reasonable.

B. APPLICABLE LAW

The Act sets forth requirements for long-term care facility (SNF and NF) participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act �� 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. Regulations governing survey, certification, and enforcement procedures, and regulations governing provider agreements, are found at Parts 488 and 489, respectively. Regulations governing appeals procedures are found at Part 498.

To participate in the Medicare and Medicaid programs, facilities periodically undergo surveys to determine whether they comply with applicable statutory and regulatory requirements for Medicare (SNFs) and/or Medicaid (NFs). They must maintain substantial compliance with program requirements, and, to be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301. Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act � 1819(b); 42 C.F.R. � 483.25. Specifically, with regard to "accidents," a facility must ensure that: 1) the resident environment remains as free of accident hazards as possible; and 2) each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h). "Accident" is defined in the State Operations Manual (SOM), interpretive rules issued by CMS, as "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." SOM Appendix PP at PP-105 (Rev. 274, June 1995); see Woodstock Care Center, DAB No. 1726, at 4 (2000), aff'd. Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose, in addition to termination, one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, including a DPNA, directed in-service training, and imposition of a CMP. See Act � 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that the facility is not in substantial compliance. 42 C.F.R. � 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. � 488.438.

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

A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing a remedy. 42 C.F.R. � 488.408(g)(2). CMS's immediate jeopardy determination must be upheld unless it is clearly erroneous. 42 C.F.R. � 498.60(c)(2). In a case where immediate jeopardy to resident health or safety has been found, I may review the level of noncompliance found by CMS only if a successful challenge on this issue would affect the range of CMP amounts that CMS could collect. 42 C.F.R. � 498.3(b)(14)(i).

When a remedy is imposed and appealed, CMS must make a prima facie showing that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). A preponderance of evidence is "superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other." Black's Law Dictionary(7th ed. 1999) (cited by the Departmental Appeals Board (Board) in Beechwood Sanitarium, DAB No. 1906, at 38 (2004)).

C. ANALYSIS

Petitioner argues that while it regrets the deaths of both residents, it met regulatory requirements and that there was no deficiency in its care and treatment of the two residents. Petitioner maintained that in order to plan and provide care for individual residents staff must focus not only on clinical treatment modalities and outcomes, but also on resident preferences and wishes, particularly, as was the case here, where the residents were in the final stages of their lives. P. Post-Hearing Brief (P.H. Br.), at 1-2. I disagree as explained more fully hereafter.

1. Petitioner was not in substantial compliance with the program participation requirement of 42 C.F.R. � 483.25 (quality of care), from November 2, 2001 through November 15, 2001.

CMS determined that Petitioner failed to substantially comply with the requirement of 42 C.F.R. � 483.25 that each resident receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. CMS determined that Petitioner failed to provide the necessary care and services to ensure that the health care needs of Resident 17 were met based upon his compromised respiratory state, insufficient oral intake, and change in condition. Further, CMS determined that the failure to provide the necessary care and services placed the resident in immediate jeopardy. CMS Ex. 3, at 5.

On November 14, 2001, Petitioner's facility was revisited and the surveyors discussed policy problems. Surveyors' notes reflect their continuing concerns regarding physician notification by Petitioner's staff. CMS Ex. 4. Specifically with regard to 42 C.F.R. � 483.25, Tag F 309, the surveyor notes indicate:

Interviews [with] staff revealed that the policy was not specific [and] would not ensure notification of change [in condition] would be made immediately when a change in condition which required medical intervention occurred. An addendum was presented 11/14/01.

Id. at 2. By letter dated November 28, 2001, CMS advised Petitioner that CMS and the state agency were satisfied that immediate jeopardy was removed on November 15, 2001. CMS Ex. 6.

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.25 (Tag F 309) at the level of immediate jeopardy for the period November 2 through 15, 2001. Petitioner has failed to rebut CMS's case by a preponderance of the evidence. My review of the record shows that Petitioner failed to provide the treatment and services required by 42 C.F.R. � 483.25 in two respects: (1) Petitioner's staff withheld Resident 17's medication on three occasions and did not notify Dr. Gordon that the medication was withheld or that low blood pressure readings prompted the action; (2) Petitioner's staff failed to administer oxygen and monitor Resident 17's oxygen saturation levels as ordered by Dr. Gordon.

By joint stipulation of undisputed facts dated June 14, 2002 (Jt. Stip.), the parties agreed that Resident 17 was admitted to Petitioner's facility on October 13, 2001 with the following diagnoses that are pertinent to this case: dementia, hypertension, congestive heart failure, COPD, and cerebral vascular accident. Further, based on his date of admission, Resident 17's Minimum Data Set (MDS), or basic assessment, was required to be completed by October 27, 2001, and his comprehensive plan of care was required to be completed by November 3, 2001. Id.

Petitioner points out that its nursing staff conducted a "head-to-toe" assessment of Resident 17 on his admission in order to develop an appropriate plan of care, and in order to determine if Resident 17 was at risk of harm in a number of key clinical areas, such as nutrition and hydration, falls, and skin breakdown. An initial plan of care focused on risk areas, including cognitive status, falls and safety, impaired skin integrity, and nutrition and hydration. P.H. Br., at 3; Tr. 208-209, 216-217; P. Exs. 7 and 10. Shortly after Resident 17's admission, Petitioner's interdisciplinary team conducted the comprehensive resident assessment and the MDS, as required by 42 C.F.R. � 483.20, which revealed that Resident 17 had significant weight loss, memory loss, that he experienced shortness of breath and unsteady gait, and that he was at high risk for falls and skin breakdown. P.H. Br., at 3-4; P. Ex. 6. Based on the comprehensive assessment, Petitioner's staff developed a comprehensive plan of care, which included a number of detailed interventions. P.H. Br., at 4; P. Ex. 8. In addition to Resident 17's diagnoses, Petitioner asserted that Resident 17 also had a history of smoking and continued to smoke during his brief admission in October 2001. Id., at 2; Tr. 158, 208.

Cindy Buckhalter, LPN and floor supervisor at the facility during the relevant period, testified that Resident 17 had previously been admitted to the facility during the summer of 2001, and that Resident 17's condition had declined considerably since his earlier admission. P.H. Br., at 2; Tr. 203-204, 206, 208. Petitioner argues that its staff and Dr. Gordon ⁽⁶⁾ did as much for Resident 17 as possible. Petitioner points out, based upon the testimony of Ms. Buckhalter, that on October 15, 2001, two days after Resident 17's admission, Ms. Buckhalter was notified that Resident 17 was not eating well and that Dr. Gordon and the dietician were notified of the problem. P.H. Br., at 4; Tr. 222. Thereafter, the staff received orders to start the resident on Megace, an appetite stimulant, and "house shakes," which have a high calorie content. P.H. Br., at 4-5; Tr. 222; P. Ex. 4, at 1; P. Ex. 7, at 7; P. Ex. 12, at 2; P. Ex. 13, at 1.

Petitioner does not dispute that after October 15, 2001, Resident 17 experienced several episodes of low blood pressure over the course of several days. P.H. Br., at 5. It is also undisputed that on October 19 and 22, 2001, Lena Driskall, ⁽⁷⁾ a nurse at Petitioner's facility who cared for and was familiar with Resident 17's clinical status, withheld Resident 17's prescribed Lasix and Prinivil because the resident's blood pressure was low. P.H. Br., at 5; Tr. 165-166; P. Ex. 12, at 3-4. CMS Ex. 16, at 83 reflects that Nurse Driskill also withheld medication on October 14, when Resident 17's blood pressure reading was 90/70, but this does not appear in the nurse note at CMS Ex. 16, at 2 and P. Ex. 12, at 1. There is no dispute that Dr. Gordon was not notified of the low blood pressure readings or that Resident 17's Lasix and Prinivil were withheld. ⁽⁸⁾

On October 23, 2001, two events are noteworthy. Resident 17 was referred to physical therapy for an evaluation due to a decline in his functional status. P.H. Br., at 5; P. Ex. 4, at 2; P. Ex. 18; P. Ex. 19. It is noted in the occupational therapy evaluation that Resident 17 was very lethargic, in fact, so lethargic that he could not verbalize his therapy goals. P. Ex. 19, at 1. Also on October 23, 2001, Petitioner's records show that Resident 17 began to receive oxygen almost constantly. P. Ex. 12, at 4-5; P. Ex. 14; Tr. 221-222.

On October 26, 2001, Resident 17 began to refuse foods and fluids and he remained in bed for longer periods of time. Tr. 222-223; P. Ex. 12, at 6-7; P. Ex. 20. Dr. Gordon was notified and he prescribed Rocephin, an antibiotic, which Resident 17 received for the next several days. P. Ex. 4, at 4; P. Ex. 13; Tr. 61.

Petitioner points out that Dr. Gordon prescribed a number of medications to attempt to stabilize Resident 17's condition, and that he instructed staff to provide oxygen on an "as needed" or "PRN" basis. P.H. Br., at 3-4; P. Ex. 3. However, Petitioner and Dr. Gordon take the position, that notwithstanding any efforts of Dr. Gordon, Resident 17 was nearing the end of his life and had no chance for recovering a useful life before death. See Tr. 159-163. Petitioner maintained that, despite its interventions, Resident 17's condition continued to decline from the day of his admission. During the morning of October 29, 2001, Resident 17 suffered a notable decline and was sent to the hospital for evaluation. P.H. Br., at 5; P. Ex. 4, at 6; P. Ex. 12, at 7. Resident 17 died at the hospital.

Petitioner has provided no evidence to show that it received a doctor's order to withhold the resident's medications and, in fact, there is really no dispute that no order was made or received. Petitioner also points to no evidence that Dr. Gordon was notified of the low blood pressure readings, and that the medication had been withheld from Resident 17. It is recorded in the SOD that Petitioner's Director of Nursing stated that medications should not have been withheld without an order of the attending physician who should have been notified of the low blood pressure reading. CMS Ex. 5, at 20. Further, the surveyor noted that in an interview with Dr. Gordon, he confirmed that he should have been notified of the resident's blood pressure because it could have been an indication of cardiac failure. Id.

Dr. Gordon testified at the hearing that he did not recall whether or not any of the survey team members called him regarding Resident 17, but he would not doubt that such an interview occurred. Tr. 140, 191. During cross-examination, Dr. Gordon clarified that he would have wanted to know about Resident 17's low blood pressure reading. Tr. 191. Dr. Gordon testified that he did not have a problem with the nurse withholding the blood pressure medication in this case because he understood that the nurse had tried to reach him and could not. Dr. Gordon did not know if the nurse contacted his backup physician. He also noted that he ultimately did talk with the nurse after the fact. Tr. 192. Whether or not Dr. Gordon can recall a conversation with a surveyor is not a significant issue affecting his credibility or the credibility of the notes in the SOD regarding his interview by the surveyor. His testimony does not contradict his statement as reported in the survey. Dr. Gordon admitted that he would want to know about Resident 17's low blood pressure and the decision to withhold medication.

In Woodstock Care Center, DAB No. 1726, at 25 (2000), quoting 54 Federal Register at 5,332, the Board said:

We recognize that a facility cannot ensure that the treatment and services will result in a positive outcome since outcomes can depend on many factors, including a resident's cooperation (i.e., the right to refuse treatment), and disease processes. However, we believe that it is reasonable to require the facility to ensure that 'treatment and services' are provided, since the basic purpose for the residents being in the facility is for the 'treatment and services' and that is why the Medicare or Medicaid program makes payment on the residents' behalf. We also think it is reasonable to require the facility to ensure that the resident does not deteriorate within the confines of a resident's right to refuse treatment and within the confines of recognized pathology and the normal aging process.

Petitioner failed to provide the treatment and services required by the regulation because Petitioner withheld Resident 17's medication without advising the physician that the medication was being withheld and the reason for that act. Moreover, the record shows that Petitioner did this on three occasions.

Furthermore, Resident 17's admission orders dated October 13, 2001, directed that he was to receive oxygen at 2 liters per minute whenever he had a pulse oximetry ⁽⁹⁾ reading of less than 90 percent. CMS Ex. 16, at 68; P. Ex. 3. On October 15, 2001, at 7:00 P.M., nurse's notes show that Resident 17 had a blood pressure reading of 90/50. At 7:25 P.M., a nurse's note indicates that Resident 17 complained of feeling faint, he had a blood pressure reading of 72/40, was helped to bed, and oxygen was started. A note at 8:35 P.M. shows that Resident 17 was laying in bed, receiving oxygen and feeling better. CMS Ex. 16, at 3. There is no evidence that Petitioner's staff did a pulse oximetry reading for Resident 17 or that staff had any idea of his actual oxygen saturation level. ⁽¹⁰⁾ There is also no evidence that Resident 17's physician was notified of this incident. Less than eight hours later, a nurse note dated and timed October 16, 2001, at 4:00 A.M., shows that Resident 17's blood pressure reading was 110/60, no distress was noted, the oxygen was off at the time with no evidence of increased shortness of breath, and the resident was ambulating around his room. CMS Ex. 16, at 4. Nothing in the nurse's notes indicate that a pulse oximetry reading was taken prior to removing the oxygen or that Petitioner's staff had any indication of Resident 17's oxygen saturation level. On October 18, 2001, at 10:00 P.M., the nurse's note shows that Resident 17 was receiving oxygen. There is no indication of when Resident 17 was put on the oxygen or what his pulse oximetry reading was at the time. On October 19, 2001, at 11:45 A.M., the nurse's note indicates that Resident 17 was receiving oxygen and "see O2 flow sheet in MAR." Id. The "Oxygen Therapy Flowsheets," for the period October 16, 2001 through October 29, 2001 are at P. Ex. 14. The flowsheets do not include an entry for oxygen saturation level.

Petitioner argues that there is "no requirement under 42 C.F.R. � 483.25 that the Facility document oxygen saturation levels or other vital signs in any particular format, or at all." P.H. Br., at 18. Petitioner is correct to the extent that the regulation does not specify documentation or format of documentation. However, it is generally accepted that the absence of documentation that a service or treatment was delivered gives rise to the inference that the service or treatment was not delivered. The burden is upon Petitioner to show that necessary care and services were delivered and absent documentation and/or other credible evidence, Petitioner cannot meet the burden. Here, as part of the necessary care and services, required or dictated by Resident 17's physician's order, a specific treatment was to be given at a specific point, i.e., administer 2 liters per minute of oxygen to Resident 17 for a pulse oximetry of less than 90 percent. There was only one way to ensure that the physician's order was properly executed and that was for Petitioner to take the necessary pulse oximetry readings. Petitioner has not produced documentation or other credible evidence to show that the necessary treatment per physician order was provided as ordered.

The testimony of Dr. Gordon and Nurse Buckhalter shows that Resident 17 was in decline, although it does not require expert medical testimony to recognize that fact. Resident 17 was clearly in a fragile state given his diagnosis and his recognized decline. Nevertheless, Petitioner failed to deliver the necessary care and services for him to attain or maintain his highest practicable state. While Dr. Gordon's testimony could be construed as minimizing the importance of the failure to advise him of low blood pressure readings and withholding of medication, he never testified that his orders for the medication were unnecessary or that violation of those orders did not present potential harm for Resident 17. Dr. Gordon also did not suggest that failure to notify him was insignificant, but, in fact, he affirmed that was the kind of information he needed to know. Further, it is clear that there are other means by which a skilled nurse can determine that oxygen needs to be administered. See Tr. 219. But in this case the order was for pulse oximetry readings to be taken, and the evidence does not show that such readings were unimportant or unnecessary given Resident 17's COPD and his fragile state. For the foregoing reasons, I conclude that Petitioner failed to substantially comply with the requirement of 42 C.F.R. � 483.25 that Resident 17 receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. CMS has also presented weighty evidence that there was a continuing problem with Petitioner's staff understanding reporting requirements and procedures throughout the period alleged. Given these facts, the declaration of immediate jeopardy as related to this deficiency was not clearly erroneous.

2. Petitioner complied with the requirement of 42 C.F.R. � 483.25(h)(2) to prevent accidents by adequately supervising Resident 14.

CMS alleges that Petitioner failed to comply substantially with the requirement of 42 C.F.R. � 483.25(h)(2), by failing to "provide supervision and assistance . . . to ensure he [Resident 14] was served the appropriate diet as assessed to meet his needs to prevent accidents, which placed the resident at substantial risk for serious physical harm or death." CMS Ex. 3, at 11-12. CMS also alleges that:

Based on the facility's failure to provide Resident #14 with food prepared in the proper consistency for which he had been assessed and determined to be the safest diet to meet his individual needs and failure to consult with the Speech Pathologist, the Medical Director, the Interdisciplinary Team or Administration prior to changing his diet placed the resident in imminent danger and substantial risk or serious physical harm or death.

Id. at 15.

CMS used yet another formulation in its post hearing brief, alleging that Petitioner "failed to ensure that Resident #14 received the appropriate diet as assessed to meet his needs." CMS Br., at 15. The CMS surveyor who cited this deficiency testified:

The basis was that the facility failed to provide this resident supervision of his care in regards to his diet. The resident had a history of choking. He had choked on a couple of occasions. He had been assessed by a speech language pathologist, who had deemed that a certain diet, a pureed diet, was the best and the safest for this resident. The facility had knowledge that the resident had choking episodes, and upon request of a family member wanted the diet changed back to a level that was not deemed safest for him by the speech language pathologist. The facility initiated this contact based upon the family's request and called the physician and the order was changed to put him back on the mechanical soft diet, which he was given.

Tr. 79. The surveyor omitted to mention that Resident 14, subsequent to the change in consistency of his diet, choked, which caused or contributed to his death.

The regulatory requirement of 42 C.F.R. � 483.25(h)(2) is that:

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

* * *

(h) Accidents. The facility must ensure that--

* * *

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

The Board has been consistent in its interpretation of this regulatory requirement. This regulation does not make a facility strictly liable for accidents that occur. The regulation does require that a facility take "reasonable" steps to ensure that a resident receives supervision and assistance devices designed to meet the resident's assessed need and to "mitigate foreseeable risks of harm from accidents." Woodstock Care Center, DAB No. 1726, at 26-27 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). After considering the drafters' rational in the preamble for the regulation, the Board in Woodstock elaborated that while facilities are not "unconditional guarantors of favorable outcomes" they do have an "affirmative duty to provide services . . . designed to achieve those outcomes to the highest practicable degree." Id. at 28 (citing 54 Fed. Reg. at 5,316, 5,332 (Feb. 2, 1989)). See Florence Park Care Center, DAB No. 1931 (2004); Northeastern Ohio Alzheimer Research Center, DAB No. 1935 (2004).

The CMS allegations regarding the basis for this deficiency citation are not clear. One formulation appears to allege that Petitioner was deficient by conceding to the wishes of the family and giving Resident 14 a mechanical soft diet after it was determined by Petitioner's staff that he was safest with a pureed diet. Another formulation appears to allege that Petitioner was deficient because it failed to supervise Resident 14's diet. However, considering the allegations of the SOD in the context of the regulatory standard, the gist of the deficiency is that Petitioner failed to provide Resident 14 adequate supervision when he attempted to consume a mechanical soft diet when Petitioner had determined that a pureed diet was safer for him, given his history of swallowing difficulty and choking. I conclude that the preponderance of the evidence shows no violation of 42 C.F.R. � 483.25(h)(2). I conclude that Petitioner did substantially comply with the requirement of 42 C.F.R. � 483.25(h)(2) to supervise Resident 14 to prevent accidents.

The Parties agreed that Resident 14, an 82 year old male, was admitted to Petitioner's facility on July 13, 2001, with orders for a pureed diet with thickened liquids, and with the following diagnoses that are pertinent to this case: multi-infarct dementia, dysphagia, and coronary heart disease. Jt. Stip. On July 17, 2001, Dr. Gordon ordered an evaluation by the speech pathologist. CMS Ex. 14, at 11. Dr. Gordon testified that he routinely deferred to the judgment of the speech pathologist regarding these types of diet issues. Tr. 175. The speech pathologist's evaluation indicated that Resident 14 had a history of swallowing difficulties as well as the other diagnoses noted above. CMS Ex. 14, at 12. The speech pathologist recommended treatment five times per week for eight weeks to "maximize swallowing" and other functions. Id. On August 1, 2001, Resident 14's diet was changed to mechanical soft with ground meats and nectar thickened liquids, with approval of the speech pathologist and doctor. Jt. Stip. Notes in Resident 14's medical record indicate that the resident experienced episodes of coughing and choking on September 11 and 13, 2001. Id. There is also evidence that on September 7, 2001, during lunch, Resident 14 choked on tomatoes that his family brought to the facility and fed to him. He was able to expel the whole tomato by coughing. CMS Ex. 14, at 100.

Resident 14 remained on the soft mechanical diet from August 1, 2001 until September 13, 2001, when his diet was changed back to pureed consistency with honey thickened liquids. On September 13, 2001, the speech pathologist discussed the diet change back to pureed consistency with the family, and the family agreed to the change. Jt. Stip. Notes in Resident 14's clinical record indicate that Resident 14's son requested that the Resident be changed back to mechanical soft foods on September 14, 2001. Jt. Stip.; CMS Ex. 14, at 107. It is undisputed that Resident 14's son was authorized to make health care decisions on Resident 14's behalf. Jt. Stip. On September 15, 2001, Resident 14 choked while eating his evening meal. Emergency measures were initiated by Petitioner's staff and by the emergency medical service who transported the Resident to the emergency room. Resident 14 died in the emergency room. CMS Ex. 14, at 18-19.

CMS argues that Petitioner should not have changed Resident 14's diet from pureed foods back to mechanical soft foods, despite the family's request to do so. Moreover, CMS maintains that Ms. Buckhalter failed to take all the actions that she should have to keep Resident 14 on the pureed foods diet. CMS asserts that Ms. Buckhalter's notation of September 13, 2001 is not clear as to whether she actually consulted with Dr. Gordon prior to changing Resident 14's diet because the entry states "diet changed to mech soft. M.D. notified." CMS Ex. 14, at 107; CMS Br., at 17. Additionally, CMS contends that Ms. Buckhalter should have contacted the speech pathologist, Ms. Downs, who "might" have been able to convince the family that Resident 14's life would be placed in great peril if he ate the mechanical soft diet. CMS Br., at 17-18. CMS alleges that although Ms. Downs, the speech pathologist, testified that there was nothing further that she would have done, Ms. Downs' last assessment on September 11, 2001 did not necessarily reflect the Resident's condition on September 14, and that a further assessment might have shown that tube feeding was necessary. CMS Br., at 17. In addition, CMS asserts that while Ms. Buckhalter and Ms. Downs stated that they explained the risks to Resident 14's family, there is little or no documentation in the record indicating the specific risks that they shared with the family. Id.; CMS Ex. 14, at 25, 31-41, 107. Finally, CMS maintains that surveyor notes of an interview with Resident 14's son on September 14, 2001, indicated that he did not talk to a nurse that day. ⁽¹¹⁾ CMS Br., at 17; CMS Ex. 14, at 7. CMS argues that the lack of documentation in the record of a detailed explanation from Petitioner that Resident 14 could choke to death on the mechanical soft diet and Resident 14's son's statement to the surveyor denying that he had a conversation with a nurse, make questionable the adequacy of Petitioner's education and counseling of the family. CMS Br., at 19. I do not find CMS's attacks upon the credibility of Ms. Buckhalter or Ms. Downs or its arguments persuasive.

In this case, Petitioner gave "adequate" supervision to Resident 14. The determinative issue is whether Petitioner did all it reasonably could to prevent injury to Resident 14 from choking, and I find that Petitioner did all it could for two reasons.

First, I agree with Petitioner that CMS has not provided any specific explanation as to how Resident 14 was not being supervised during meals, or that he was not provided the appropriate tools necessary to assist him while eating. While the evidence shows that on several occasions, prior to the one that led to his death, Resident 14 had choking episodes, this is not evidence of Petitioner's failure to supervise. Indeed, CMS's witness admitted that Resident 14 received one-to-one supervision during meals from a nurse, a certified nurse aide or a family member. Tr. 86-87.

Second, Petitioner's actions were not deficient because Ms. Buckhalter did not consult Ms. Downs before changing Resident 14's diet on September 14, 2001. The regulation does not require that a facility anticipate every conceivable outcome, and exhaust every possible course of action, before settling on an appropriate plan of care, or before agreeing to honor the request of a resident or responsible party. As the ALJ in Sunbridge Care and Rehabilitation of Escondido East, DAB CR891, at 35 (2002), stated:

[T]he absence of regulatory standards and mandated interventions that must be attempted means that a determination of whether a facility is in compliance entails a degree of subjectivity. Here, I find substantial compliance because the record demonstrates that the facility was taking appropriate, reasonable measures to deal with a resident's particular needs, desires and abilities.

I find Petitioner was not in violation because the record demonstrates that the facility was taking appropriate, reasonable measures to deal with Resident 14's particular needs and the desires of Resident 14's family member who was authorized to make health care determinations.

CMS's argument that there is little or no documentation in the record indicating that the specific risks of choking were shared with Resident 14's family is contrary to the facts in this case. It is, in fact, Resident 14's son's request that is at the center of this issue. There is ample evidence regarding Resident 14's swallowing difficulties, the on-going evaluations, and the steps taken by Petitioner to attempt to improve Resident 14's condition. See, e.g., CMS Ex. 5; P. Ex. 3, 25, and 28. Not only is the record replete with references to Resident 14's family, but the speech pathologist testified that Resident 14's wife and son were very active in his care. Tr. 297. The speech pathologist testified that the family was present during therapy sessions:

[A]t least twice a week in actual therapy sessions. Because I usually try to treat during a meal if I'm working with dysphagia, two to three times a week. . . . They would also frequently come to our office or the gym area, and ask us about his progress.

Tr. 298. The speech pathologist testified that the family had received training on the feeding of Resident 14. Tr. 299. Further, the speech pathologist testified that the family was counseled on more than one occasion about the need to adhere to Resident 14's diet:

Q: Can you tell us on how many occasions, you don't have to be specific, but approximately how many occasions you - were made aware of, either the family bringing in contra-indicated food, or the resident being feed [sic] things he should not have been feed [sic].

A: Oh, I can, it's been a long time. I can remember maybe four or five times. And, you know, if we were aware of that four or five times then, you know, we don't know how many times it happened.

Q: And do you recall on - if all or some of those occasions that you spoke with the family about the concerns you had.

A: I talked with them every time, at least twice a week, like I said I spoke with them about my concerns for his feeding.

Tr. 301. Ms. Buckhalter testified that, in consulting with the speech pathologist, she was informed that the son was aware of the choking danger and agreed, at the time, to a pureed diet, but stated that "he would not promise that he would not request it being upgraded again." Tr. 233. Ms. Buckhalter's testimony is supported by the testimony of Dr. Gordon:

Q: Let me ask you: Do you recall in your conversation with the nurse whether you asked them if they had spoken with the family about the risks of making that change?

A: Yes.

Q: What did the nurse tell you?

A: Yes, they had. They tried to make it very clear to the family.

Q: Tried to make what very clear to the family?

A: That there was supposedly some increased risk of problems with the mechanical soft diet as opposed to the pureed diet.

Q: Were you comfortable at the time that you agree to the diet change that the family had been -- based on what you knew of the family in the past and that call, the family understood what the risks were?

A: Oh, absolutely.

Tr. 150. Furthermore, CMS's argument that the speech pathologist "might have been able to convince" the family to allow Resident 14 to remain on the pureed diet is, as Petitioner argued, based only on speculation and contrary to the facts in this case and to testimony by the speech pathologist:

[T]hey did not want to go to puree. They just kept saying, we'll see what -- and putting me off didn't want to go to puree. It was finally on 9/13, I was working with a patient and his family in the dining room at lunch, and he started to choke. And the son immediately stuck his finger in his Father's throat and pulled out a -- chunk of ground meat that had kind of formed together in his throat. Maybe close to the size of a golf ball, maybe a bit smaller. Tr. 306.

I did tell them that yes, his Dad does tolerate mechanical soft okay at times, but very obvious from what happened that day that it -- it only took one time, for him to choke that badly. And the son at that point was in agreement, going to the puree diet, said that he would try it. But he also said, now I may throw a fit and send this back, as soon as I've seen -- as soon as I see it. And I told him that, you know, we were going to continue therapy, we weren't going to quit. That we were just putting him on the puree diet for now, but hopefully we would get him strong and -- we could advance his diet. And that it was not set in stone, that he just, was very clear, that yes I could change the diet to puree, but he -- he thought he might change it back . . . and wanted that option. Tr. 307.

Despite CMS's position, CMS has pointed to no requirement that Ms. Downs, the speech pathologist, be contacted when Ms. Buckhalter contacted Dr. Gordon about the diet change from pureed to mechanical soft for Resident 14. As noted above, Dr. Gordon testified that he was "absolutely" satisfied that the family had been counseled, and the evidence supports this position. Ms. Downs testified that she was not surprised that she was not contacted about the change because she and Ms. Buckhalter had just discussed the matter the day before and Ms. Buckhalter called Dr. Gordon who had the authority to order the change. Tr. 310. ⁽¹²⁾

The evidence is that Resident 14 was assessed and reassessed and care planned. ⁽¹³⁾ Resident 14 was supervised one-on-one for eating either by trained staff or trained family members or both. The change from pureed diet to mechanical soft diet increased the risk for choking, but the change was a medical decision by Resident 14's treating doctor who was aware of the resident's condition. Furthermore, Petitioner had already taken reasonable steps to ensure that Resident 14 was adequately supervised to deal with accidental choking. Whether or not Resident 14 might have been better off with a feeding tube is purely speculative and a medical decision that the resident's doctor did not make. Whether or not Ms. Downs could have convinced the resident's son not to insist upon returning to a mechanical soft diet is also entirely speculative, but the evidence certainly indicates that the son probably would not have been convinced. Petitioner is entrusted with balancing necessary care and services with the resident's right to refuse treatment. In the case of Resident 14, Petitioner decided to honor the resident's right to insist upon a certain diet and then maintained an appropriate level of supervision given the additional risk of harm to that resident. Consequently, I determine that the preponderance of the evidence is that Petitioner complied with the requirements of 42 C.F.R. � 483.25(h)(2) with regard to Resident 14. Absent a deficiency, the declaration of immediate jeopardy is clearly erroneous.

3. The amount of the CMP is not reasonable.

My conclusion that Petitioner failed to comply substantially with 42 C.F.R. � 483.25, Tag F 309, provides a basis for the imposition of a CMP. The issue remaining is whether the amount of the CMP proposed by CMS is reasonable. CMS imposed a CMP of $4,050 per day from November 2, 2001 through November 15, 2001.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making process. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard to CMS's discretion. Community Nursing Home, DAB No. 1807, at 22, et seq.; CarePlex, DAB No. 1638, at 8.

CMS maintains that measured against the applicable factors, the imposition of a CMP of $4,050 per day is reasonable. Further, CMS asserts that its CMP is in the lower range (of $3,050 to $10,000 per day) for deficiencies found to constitute immediate jeopardy. Based on my finding that Petitioner failed to comply with one requirement, 42 C.F.R. � 483.25, Tag F 309, rather than two requirements as asserted by CMS, I determine that a CMP of $4,050 per day is not reasonable, and I therefore reduce the CMP at issue to $3,050 per day for the period November 2, 2001 through November 15, 2001. This CMP is the lowest of the range of CMPs that may be imposed for a deficiency that presents immediate jeopardy.

IV. CONCLUSION

For the foregoing reasons, I conclude as follows:

There is a basis for a remedy in that Petitioner violated 42 C.F.R. � 483.25, Tag F 309, by failing to provide necessary care and services to Resident 17.

A CMP of $3,050 per day for the period November 2, 2001 through November 15, 2001 is reasonable in this case.

Keith W. Sickendick

Administrative Law Judge

1. It has been represented to me that the survey which led to the two deficiencies before me included additional deficiency citations and remedies. Petitioner, in its request for hearing dated January 4, 2002, clearly disputes only the two deficiencies cited on the survey of November 2, 2001 identified as Tag F 309 (42 C.F.R. � 483.25) and Tag F 324 (42 C.F.R. � 483.25(h)(2)) and the CMP of $4,050 for the period November 2 to 15, 2001, which was based on the two deficiencies. Request for Hearing, January 4, 2002, at 2. CMS requests in a footnote of its brief that I summarily affirm the unappealed deficiency citations and related remedies. CMS Brief (Br.), at 3, fn. 4. I am, of course, not inclined to affirm anything that I have not had the opportunity to review. There is also an issue, under 42 C.F.R. Part 498, of whether or not I even have jurisdiction to pass upon unappealed deficiency citations and related remedies. In this case I have only reviewed those deficiency citations and the related CMP appealed to me. I take no action on those deficiency citations and remedies not appealed, and I intend no effect upon the CMS action as to those deficiencies and remedies which became final when they were not appealed.

2. Immediate jeopardy means 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. 42 C.F.R. � 488.301.

3. Ms. Downs appeared by telephone at the request of Petitioner. CMS did not object to receiving Ms. Down's testimony by telephone. Tr. 290.

4. CMS represents in its brief that COPD is a condition with generalized airways obstruction, particularly of small airways, associated with varying combinations of chronic bronchitis, asthma and emphysema. CMS Br., at 7, fn. 8 (citing The Merck Manual of Diagnosis and Therapy, 636-643 (15^th ed. 1987). Petitioner has not objected to this definition. See also Dr. Gordon's testimony at Tr. 158.

5. Substandard quality of care is declared when there is one or more deficiencies under 42 C.F.R. �� 483.13, 483.15, or 483.25 and there is either immediate jeopardy, a pattern of or widespread actual harm, or a widespread potential for more than minimal harm. 42 C.F.R. � 488.301. In this case, the allegation of substandard quality of care is premised upon the two alleged deficiencies under 42 C.F.R. � 483.25 at the immediate jeopardy level.

6. Dr. Gordon was treating physician for both the residents involved in the two deficiency citations at issue, Residents 17 and 14.

7. Ms. Driskall did not testify at the hearing.

8. The evidence does show that on October 24, 2001, the pharmacist for Petitioner's facility recommended that the physician reduce Resident 17's blood pressure medications based on several low blood pressure readings, but Dr. Gordon did not approve that recommended change until November 1, 2001. P.H. Br., at 5; P. Ex. 5.

9. At the hearing, a CMS witness testified that pulse oximetry is performed by affixing a pulse oximeter onto the finger, which gives a reading as to what the oxygen level is in the blood. See Tr. 53.

10. Nurse Buckhalter testified that she told the surveyor that Petitioner's staff usually did document oxygen saturation levels, and she could not explain why they were not documented for Resident 17. Ms. Buckhalter testified that she received verbal reports from the nurses that they did monitor oxygen saturation for Resident 17, but she was not specific as to whether pulse oximeter readings were obtained for the instances discussed herein. Tr. 224.

11. Petitioner points out that the SOD indicates that the interview with Resident 14's son actually took place more than 48 days after the incident occurred, and CMS did not offer the son as a witness to either confirm or deny the accuracy of the facility's documentation. See CMS Ex. 5, at 31. Petitioner asserts that the documentation contained in Resident 14's clinical record was made contemporaneously with the event, and thus provides a more credible account of what actually occurred on September 14, 2001. See CMS Ex. 14, at 107; P. Ex. 32, at 43.

12. Ms. Downs also testified that she was not as concerned about the resident choking on food as she was about him aspirating food particles into his lungs. She explained that in the nursing home environment choking on a chunk of food could be dealt with as staff is trained and Resident 14 was receiving one-on-one supervision. Her primary concern was not that Resident 14 would choke, but rather that he would aspirate food particles which in his weakened state could lead to aspiration pneumonia with respiratory distress from which he could not recover. She noted that the risk for aspiration existed with a pureed diet too. Tr. 311. Dr. Gordon testified that it is a no win situation with someone in Resident 14's condition because they may choke on solids and aspirate liquids. Tr. 145, 174.

13. The resident's care plan was detailed and included several interventions, including assistive devices. See P. Ex. 24, at 1-3.