SUBJECT:

Hertiage Park Nursing Center,

Petitioner,

Centers for Medicare & Medicaid

DECISION

Petitioner failed to substantially comply with 18 Medicare and Medicaid requirements, three of them at the immediate jeopardy level. Accordingly, I find that there is a basis for the imposition of a civil money penalty (CMP) of $5,050 per day from July 29, 1999-August 10, 1999, for the deficiencies at the immediate jeopardy level. And, I also find that there is a basis for the imposition of a CMP of $150 per day from August 11, 1999-September 29, 1999, for the 15 remaining deficiencies. Furthermore, I find that both CMPs, totaling $73,150, are reasonable.

I. Procedural History

On August 17, 1999 the Arkansas Department of Human Services (surveyors) concluded a survey of Heritage Park Nursing Center (Petitioner or Facility). The surveyors recorded 18 deficiencies on the statement of deficiencies (the survey report, also known as CMS Form-2567 or 2567), for failure to comply with Medicare and Medicaid participation requirements. By letter dated October 8, 1999, the Centers for Medicare & Medicaid Services (CMS (formerly named the Health Care Financing Administration (HCFA)) notified Petitioner of its findings, based on the surveyors' report, that Petitioner was non-compliant with Medicare and Medicaid requirements. And, in the same letter, CMS notified Petitioner of the imposition of the CMPs.

Petitioner appealed CMS's findings and requested a hearing, by letter dated October 28, 1999. Petitioner's request for a hearing was received by the Civil Remedies Division of the Departmental Appeals Board (DAB) on November 1, 1999. The case was assigned to Administrative Law Judge Marc R. Hillson for a hearing and decision. It was subsequently reassigned to Administrative Law Judge Carolyn C. Hughes, and then ultimately reassigned to me.

I decide this matter based on the parties' submissions, without an in-person hearing. It is allowable to proceed to a decision without an in-person hearing when the parties consent. 42 C.F.R. � 498.66. The parties decided to forgo an in-person hearing and opted instead to have me decide the case based on a written record. The parties initially communicated their intent to waive an in-person hearing to me orally. I memorialized the parties' request in my order establishing a briefing schedule dated October 25, 2001. Subsequently, the parties submitted written confirmation of their intent to waive an in-person hearing. Petitioner wrote:

Petitioner intends the material facts have been stipulated by Joint Stipulations of Fact filed in the matter on October 10, 2001. The disputes remaining are related to the finding of deficient practice by the State Survey Agency and the imposition of remedies relying upon a finding of actual harm. The respondent has acted inconsistent and noncompliant with legal authority in its determination and imposition of remedies. Therefore, the Petitioner is entitled to a favorable decision as a matter of law.

Petitioner's Response to Motion for Summary Disposition (Petitioner's Response). And, I note that Petitioner also wrote:

Petitioner accepts the Respondent's preliminary statement as an accurate chronology of events relative to this appeal. However, while the Petitioner agreed with the material facts as identified in the Joint Stipulations of Facts, the Petitioner continues to dispute findings of noncompliance and the imposition of remedies as they relate to matters of law. The imposition and the amount of the civil money penalty were not properly instituted against the Petitioner.

Petitioner's Brief in Support of Cross Motion for Summary Disposition and Denial of Respondent's Motion for Summary Judgment (Petitioner's Brief).

After reviewing the parties' joint stipulations of fact and the parties' briefs, however, it is not clear that Petitioner ceased to argue all points of fact. For instance, the most serious allegations of noncompliance concern the failure of the Facility's call light system; which is a system of lights and buzzers, operated by buttons located in the resident's rooms, and used by residents to summon nursing staff for assistance. It is stipulated that the call light system failed so that it required repair. It is uncontested that the system was subsequently replaced. Nonetheless, in the briefing of this case, Petitioner made arguments concerning the extent of the call light system's malfunction, and provided evidence to refute CMS's contention that Facility staff told surveyors the call light system had completely failed, or words to that effect. Issues concerning how badly broken a thing is, or who said what to whom at any given time, are issues of fact, not law. But, because the parties expressed their intent to have me decide the case without an in-person hearing, submitted documentary evidence that allows me to decide the fact issues, and did not withdraw their waiver of an in-person hearing after the record was complete, I find that it is appropriate to decide this matter on the documentary record without an in-person hearing. Accordingly, I rely on the parties' Joint Stipulations of Fact and the evidence submitted by the parties in making my Findings of Fact (below).

The parties submitted stipulations, exhibits and affidavits. The parties' Joint Stipulations of Fact was received on October 15, 2001. CMS submitted CMS Exhibits (CMS Exs.) 1-27 and four affidavits. I admit the CMS Exhibits and the affidavits of Mary Ann Smith, Suzanne Ray, Karol Burrow and Daniel J. McElroy. Petitioner submitted Petitioner's Exhibits (P. Exs.) 1-120; I admit Petitioner's Exhibits. Petitioner also submitted a handwritten statement, attached to Petitioner's Brief, that is apparently signed by three members of the Facility's staff: the Administrator, Maintenance Supervisor and Housekeeping Supervisor. The statement is marked "exhibit 1." I redesignate the statement P. Ex. 121 and I admit it.

The parties presented the case through cross motions and briefs. CMS's Motion for Summary Judgment and Brief in Support of Motion for Summary Judgment (CMS's Brief), was received December 11, 2002; Petitioner's Response to Motion for Summary Disposition and Brief in Support of Cross Motion for Summary Disposition and Denial of Respondent's Motion for Summary Disposition (Petitioner's Brief), was received January 25, 2002; and, CMS's Reply to Petitioner's Cross Motion for Summary Disposition and Denial of Respondent's Motion for Summary Disposition (CMS's Reply), was received February 15, 2002.

II. Findings of Fact

1. Petitioner was the subject of a survey that concluded on August 17, 1999 (survey); and, as a result of that survey, Petitioner was found out of compliance with Medicare participation requirements.

2. By letter dated October 8, 1999 CMS notified Petitioner that it would be assessed a CMP of $5,050 per day from July 7-August 10, 1999, for deficiencies at the immediate jeopardy level of severity, and a CMP of $150 per day from August 11-September 29, 1999, for other deficiencies at less than the immediate jeopardy level of severity. The total of the two CMPs is $73,150. Stipulated Facts 102-103.

3. By letter dated October 28, 1999 Petitioner requested a hearing before an administrative law judge.

4. Petitioner was cited for violating 42 C.F.R. � 483.70(f), at the scope and severity level K. This deficiency is F Tag 463 ⁽¹⁾: the nurse's station must be equipped to receive resident calls through a communication system from resident rooms, and toilet and bathing facilities. F Tag 463 is supported by facts concerning two residents:

a. When activated by a resident, the call light system would cause a light in the hallway above each resident's room to light, and another light on a panel light board at each nurse's station to light and buzz. Stipulated Fact 94.

b. Resident 3 had a diagnosis of Cerebral Vascular Accident and was assessed on August 9, 1999 as totally dependent. Resident 3 had the use of her hands but required extensive assistance for all activities of daily living. Stipulated Fact 63.

i. Resident 3 was aphasic. Aphasia is a communication disorder that can affect a person's ability to use and understand spoken or written words. Stipulated Fact 64; Karol Burrow Affidavit at 3.

ii. Resident 3 lived on B Hall. CMS Ex. 8, at 1.

c. Resident 10 was assessed on the Minimum Data Set, dated August 6, 1999, as cognitively alert without any short term or long term memory problems. Stipulated Facts 11, 57.

i. Resident 10 had diagnoses of Insulin Dependent Diabetes, Valvular Heart disease, Congestive Heart Failure, Compression Fracture L1, status post Cerebral Vascular Accident with right sided effects, Stasis Dermatitis, and having shortness of breath and requiring oxygen as needed. Stipulated Fact 58.

ii. Resident 10 required the assistance of two people for transfers, walking in the room and toilet use. CMS Ex. 15, at 47.

iii. On August 9, 1999 Resident 10 complained that the call lights in her room and in her bathroom were broken. CMS Ex. 15, at 4.

iv. The resident call light system for Rooms 32 and 34 on B Hall were not functioning properly between 9:55-10:20 A.M. on August 10, 1999. CMS Ex. 25, at 16; Karol Burrow Affidavit at 3.

v. Resident 10 lived in Room 16B on B Hall. Stipulated Fact 59.

vi. Resident 10 shared her room with her son, who was assessed as independent with transfers, but having poor balance and weighing 240 pounds. Stipulated Facts 60-61.

vii. On August 10, 1999 Resident 10's son fell in his room. Stipulated Fact 62.

viii. The staff nurse who assisted Resident 10's son when he fell, left the room to obtain assistance--she did not use the resident call light system. Petitioner's Brief at 14.

ix. On August 10, 1999 at 10:32 A.M., the call light for Rooms 16 and 34 on B Hall were not working. CMS Ex. 15, at 11.

d. The Facility did not have an alternate communication system to back up its resident call light system. Instead, Facility staff were assigned to check residents every two hours. CMS Ex. 25, at 18.

e. The Facility's Maintenance Supervisor indicated that he knew the call light system had been broken since July 29, 1999. CMS Ex. 15, at 11; CMS Ex. 25; Karol Burrow Affidavit at 3-4; Paula Smith Affidavit at 2-3; P. Ex. 121.

f. The Facility telephoned a service technician about the broken call light system on August 4, 1999 and August 6, 1999. P. Ex. 9, at 1-2.

g. The Facility began the checks on residents once every two hours on August 5, 1999. P. Ex. 8.

h. On August 10, 1999 the Facility provided cowbells to residents as a means of communicating while the call light system was not functioning and instituted a policy to be followed in case of call light system failure. CMS Ex. 22.

5. Petitioner was cited for violating 42 C.F.R. � 483.75 at the scope and severity level K. This deficiency is F Tag 490: the facility must develop and implement appropriate plans of action to correct identified quality deficiencies. Concerning F Tag 490:

a. During the immediate jeopardy period, the Facility's Administrator knew that the resident call light system was not working. Karol Burrow Affidavit; Paula Smith Affidavit; CMS Ex. 25.

b. During the immediate jeopardy period, the Facility's Director of Nurses knew that the resident call light system was not working. Karol Burrow Affidavit; Paula Smith Affidavit; CMS Ex. 25.

c. The Facility had no policy or procedure in place in anticipation of a failure of the resident call light system, and the Facility had no alternate communication system. Karol Burrow Affidavit; CMS Ex. 25, at 18.

6. Petitioner was cited for violating 42 C.F.R. � 483.75(o)(2) and (3) at the scope and severity level K. This deficiency is F Tag 521: the facility must have a quality assurance and assessment committee that meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary; and the committee develops and implements appropriate plans of action to correct identified quality deficiencies. Concerning F Tag 521:

a. The minutes of the Quality Assessment and Assurance Committee do not show that the broken resident call light system was discussed. Suzanne Ray Affidavit.

b. A Quality Assessment and Assurance Committee Meeting was held on July 27, 1999. No additional meetings were held to address the state of the resident call light system or alternative communication systems. CMS Ex. 26, at 15.

7. Petitioner was cited for violating 42 C.F.R. � 483.10(b), at the scope and severity level D. This deficiency is F Tag 157: the facility must immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or interested family member when there is a significant change in the resident's physical, mental or psychosocial status (i.e. a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications). F Tag 157 is supported by the following facts:

a. The Facility's Notification of Changes policy and procedures lists the emergence of a decubitus ulcer as a significant change. CMS Ex. 28, at 9.

b. A decubitus ulcer is the same as a pressure sore, pressure ulcer, decubitus, or decubiti. Stipulated Fact 2.

c. The Facility's procedures for notification of changes requires that a resident's family and physician must be notified within twenty-four hours of a significant change. CMS Ex. 28, at 9.

d. On August 7, 1999 Resident 13 had a stage II pressure sore on the left buttock measuring 0.5 cm. Stipulated Fact 3.

i. Resident 13's pressure sore was noted by the staff in the Weekly Skin Audit Report, by the 3-11 shift. Stipulated Fact 4.

ii. Resident 13's physician was notified of the Resident's pressure sore on August 12, 1999 at 11:25 A.M., when a physician's telephone order was received. CMS Ex. 18, at 7.

iii. The Facility notified Resident 13's family that he had a pressure sore on August 13, 1999 at 10:45 A.M. CMS Ex. 18, at 11.

iv. The Facility had no treatment records for the pressure sore on Resident 13's left buttock. CMS Ex. 24, at 14.

v. On August 12, 1999 Resident 13 had stage II pressure sores on the left buttock and the right coccyx. Stipulated Fact 5.

vi. On August 12, 1999 the pressure sore on Resident 13's left buttock had decreased in size since August 7, 1999, but remained the same depth and color. CMS Ex. 18, at 8.

e. On August 6, 1999 Resident 18 had a stage II pressure sore, 1cm. in size, on his scrotum. Stipulated Fact 6.

i. The Nurse's Notes do not show that the Facility notified Resident 18's family regarding his pressure sore. Stipulated Fact 7.

f. On July 28, 1999 at 1:55 P.M. the Facility received a physician's order to treat an excoriated area on Resident 19's scrotum. Stipulated Fact 8.

i. As of August 9, 1999 there is no documentation in the Facility's Nursing Notes that Resident 19's family was notified of the change in his condition, requiring medication and treatment changes. Stipulated Fact 9.

ii. The Weekly Skin Audit report dated August 8, 1999 and August 10, 1999, documented that the excoriation to Resident 19's scrotum remained improved and treatment continued. Stipulated Fact 23.

iii. The Weekly Skin Audit report dated August 12, 1999, noted that Resident 19 had a pressure sore on his scrotum measuring 1.2 x 8 cm. Stipulated Fact 10.

iv. On August 12, 1999 Resident 19's pressure sore was a stage II pressure sore. CMS Ex. 3, at 27

v. On August 17, 1999 there was no documentation in the Nurse's Notes that the Facility had notified Resident 19's physician or family that he had a stage II pressure sore. CMS Ex. 21.

8. Petitioner was cited for violating 42 C.F.R. � 483.10(f)(2) at the scope and severity level D. This deficiency is F Tag 166: residents have the right to prompt the facility to resolve grievances, including those with respect to the behavior of other residents. F Tag 166 is supported by facts concerning one resident:

a. On August 9, 1999 Resident 10 complained that the resident call lights in her room and bathroom were broken. Stipulated Fact 12.

b. Resident 10 had complained about the broken call lights to the Facility's staff prior to the survey. CMS Ex. 15, at 4.

c. The Facility's maintenance records had no documentation of Resident 10's complaints about the broken call lights. CMS Ex. 3, at 3.

9. Petitioner was cited for violating 42 C.F.R. � 483.15(a)(2) at the scope and severity level D. This deficiency is F Tag 241: the facility must promote care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect in full recognition of each resident's individuality. Concerning F Tag 241, five medications were given to a resident while the resident sat on the toilet in a bathroom which stank of feces. CMS Ex. 3, at 4.

10. Petitioner was cited for violating 42 C.F.R. � 483.20(b)(2)(ii), at the scope and severity level D. This deficiency is F Tag 274: the facility must conduct a comprehensive assessment of a resident within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. F Tag 274 is supported by facts concerning one resident:

a. Resident 5 was admitted to the Facility on October 28, 1998. He had diagnoses of Chronic Obstructive Pulmonary Disease, Renal Insufficiency, Non-Insulin Dependent Diabetes Mellitus, Bilateral Below Knee Amputee, Peripheral Vascular Disease, Coronary Artery Disease, and Hypothyroidism. CMS Ex.10, at 1, 9.

b. On the Minimum Data Set dated November 11, 1998, Resident 5 was assessed to be cognitively aware, continent of bowel and bladder and free of pressure sores. CMS Ex. 10, at 15, 17-18.

c. On May 11, 1999 Resident 5's quarterly review assessment showed he was frequently incontinent of bladder, occasionally incontinent of bowel and had a stage II pressure sore. CMS Ex. 10, at 20, 22-23; CMS Ex. 24, at 8.

11. Petitioner was cited for violating 42 C.F.R. � 483.20(b)(2)(iii), at the scope and severity level D. This deficiency is F Tag 275: the facility must conduct a comprehensive assessment of the resident not less often than once every 12 months. F Tag 275 is supported by facts concerning one resident:

a. Resident 19 had diagnoses of Weight Loss, Agitation and Peripheral Vascular Disease. Stipulated Fact 21.

b. As of August 13, 1999 the Facility's most current annual assessment for Resident 19 was dated November 27, 1997. Stipulated Fact 14.

c. The Facility did not conduct Resident 19's assessment for 1998. CMS Ex. 24, at 9.

12. Petitioner was cited for violating 42 C.F.R. � 483.20(k)(3)(ii), at the scope and severity level G. This deficiency is F Tag 282: the services provided or arranged by the facility must be provided by qualified persons in accordance with each resident's written plan of care. F Tag 282 is supported by facts concerning one resident:

a. Resident 5 was totally dependant for all transfers and toilet use. Stipulated Fact 16

b. On July 25, 1999 Resident 5 was admitted to the hospital with a diagnosis of Probable Volume Depletion. Stipulated Fact 17.

c. A physician's order, dated July 22, 1999, directed that a number of tests be taken: Complete Blood Count, Sedrate, Thyroid Stimulating Hormone, Blood Urea Nitrogen, Creatinine, Sodium, Potassium, Cholesterol, Liver Function and Stool Quaic x 3 for a diagnosis of abnormal weight loss. CMS Ex. 10, at 26-27.

d. After July 22, 1999 Resident 5's physician discontinued the order for the Creatinine tests and ordered monthly Lactic Acid tests. CMS Ex. 10, at 32.

e. The Facility only conducted the Lactic Acid test. CMS Ex. 10, at 34.

13. Petitioner was cited for violating 42 C.F.R. � 483.25(c) at the scope and severity level H. This deficiency is F Tag 314: the facility must ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they are unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. F Tag 314 is supported by facts concerning seven residents:

a. Resident 1 was assessed in the minimum data set for February 24, 1999 and May 26, 1999, as incontinent of bowel and bladder and at risk for pressure sores. Stipulated Fact 25.

i. The May 26, 1999 minimum data set indicated that Resident 1 needed pressure relieving devices for his chair and bed. Stipulated Fact 26.

ii. Surveyors discovered Resident 1 seated on one inch high egg crate cushion. One inch high egg crate is an outdated kind of egg crate cushion and it does not provide pressure relief. CMS Ex. 6, at 4.

b. Resident 2 had a history of pressure sores, and, on January 22, 1999, was assessed cognitively impaired, dependant for transfers, dressing and hygiene, incontinent of bowel and bladder, and at risk for pressure sores. Stipulated Fact 28.

i. On August 11, 1999 Resident 2 sat in the same marked position in the activity room from 9:31A.M. until 12:45 P.M. CMS Ex. 7, at 4-5.

ii. At 12:45 P.M., on August 11, 1999, staff took Resident 2 to her room for incontinence care. CMS Ex. 7, at 5.

iii. Resident 2's slacks and incontinence pad were soiled with feces and urine. CMS Ex. 7, at 5.

iv. The LPN providing incontinence care to Resident 2 cleaned her with soap and water, but did not dry Resident 2 or clean the front part of Resident 2's body. CMS Ex. 7, at 5.

c. In a quarterly review dated May 27, 1999, Resident 4 was assessed totally incontinent of bowel and bladder and totally dependent for grooming and hygiene. Stipulated Fact 27.

i. Resident 4 had a history of pressure sores. CMS Ex. 9, at 3.

ii. On August 11, 1999 Resident 4 received incontinent care at 10:50 A.M. and 4:40 P.M. On neither occasion did Facility staff use soap or peri-wash when performing the incontinent care. CMS Ex. 9, at 4.

iii. The Facility's instructions on how to perform perineal care for incontinent patients indicates that peri-wash is required. CMS Ex. 9, at 23.

d. Resident 8 was assessed cognitively alert, dependent on staff for transfers, bathing, dressing and personal hygiene. Stipulated Fact 29.

i. Resident 8 had a history of pressure sores. Stipulated Fact 30.

ii. The Facility was required to provide Resident 8 with pressure relieving devices in her bed and chair. Stipulated Fact 31.

iii. In the Plan of Care dated July 21, 1999, it was identified that Resident 8 had an excoriation on her peri-anal buttock. It was determined that this problem would be resolved by July 30, 1999. Stipulated Fact 32.

iv. On August 11, 1999 Resident 8 remained sitting in the same marked position in her wheelchair, without a pressure relief device, from 10:45 A.M. to 1:05 P.M. CMS Ex. 13, at 4-5.

v. From 10:45 A.M. until 1:05 P.M., on August 11, 1999, Resident 8 was seated on a quartered incontinent pad. CMS Ex. 13, at 4.

e. In a significant change assessment, dated August 6, 1999, Resident 10 was assessed frequently incontinent of bladder, requiring two-person assistance for transfer, toileting and bathing, and totally dependent on staff for personal hygiene. Stipulated Fact 33.

i. Resident 10 was readmitted to the Facility from St. Mary's Hospital on August 2, 1999. Stipulated Fact 34.

ii. Resident 10 had stage II pressure sores on August 2, 1999. Stipulated Fact 36.

iii. By August 14, 1999 Resident 10's pressure sores were improving. Stipulated Fact 37.

iv. On August 16, 1999 at 11:25 A.M., there were feces and urine around the pressure sores on Resident 10's coccyx and left lower buttock. CMS Ex. 15, at 9.

v. The Facility's policy required that decubitus ulcers be kept as clean as possible. CMS Ex. 15, at 82.

vi. On August 16, 1999 at 11:25 A.M., there were no dressings on the pressure sores on Resident 10's coccyx and left lower buttock. CMS Ex. 15, at 9.

vii. The LPN providing care to Resident 10 on August 16, 1999, at 11:25 A.M., indicated that the dressings on Resident 10's pressure sores had been removed to give the pressure sore areas air. CMS Ex. 15, at 9.

viii. The physician's orders for Resident 10 did not instruct staff to remove dressings to give Resident 10's pressure sores air. CMS Ex. 15, at 57.

ix. On August 16, 1999 the pressure sore on Resident 10's coccyx was a 4 cm., dark red, unblanchable area, surrounded by an approximately 3 cm. area of yellow slough, with an approximate 2 cm. necrotic area. CMS Ex. 15, at 9.

x. On August 16, 1999 the pressure sore on Resident 10's left buttock had a quarter size, dark red, unblanchable area, with an approximate 0.6 cm. area of yellow slough and 0.5 cm. dark necrotic area. CMS Ex. 15, at 9.

f. Resident 13 had diagnoses of Vascular Dementia, Prostate Cancer, Coronary Artery Disease, Anemia, Constipation, Edema and was totally dependent for all activities of daily living. Stipulated Fact 18.

i. The August 7, 1999 Weekly Skin Audit Report showed that Resident 13 had a stage II pressure sore on the left buttock. Stipulated Fact 19.

ii. No treatment order was obtained, nor was Resident 13's physician notified, concerning the pressure sore on Resident 13's left buttock, until August 12, 1999 at 11:25 A.M., when a physician's telephone order was received. CMS Ex. 18, at 7.

iii. By August 12, 1999 at 11:25 A.M., Resident 13 had developed an additional pressure sore. The Facility's Pressure Sore Record for August 12, 1999 reflected that Resident 13 had stage II pressure sores on the left buttock and the right coccyx. Stipulated Facts 5; 20.

iv. The Facility's records show that the pressure sore on Resident 13's left buttock decreased in size, but remained the same color and depth. CMS Ex. 18, at 8.

g. Resident 19 had diagnoses of Weight Loss, Agitation, and Peripheral Vascular Disease. Stipulated Fact 21.

i. In the Minimum Data Set, dated May 26, 1999, Resident 19 was assessed as totally dependent for the activities of daily living. Stipulated Fact 22.

ii. The Weekly Skin Audit Report, dated August 8, 1999 and August 10, 1999, documents that the excoriation to Resident 19's scrotum remained improved, and that treatment continued. Stipulated Fact 23.

iii. The Weekly Skin Audit Report, dated August 12, 1999, documents a 1.2 cm. x .8 cm. pressure sore on Resident 19's scrotum. Stipulated Fact 24.

14. Petitioner was cited for violating 42 C.F.R. � 483.25(h)(1) at the scope and severity level D. This deficiency is F Tag 323: the facility must ensure that the resident environment remains as free of accident hazards as possible. Concerning F Tag 323 I find the following facts:

a. On August 13, 1999 at 10:50 A.M., the medication room door at the C Hall nurse station, in the Alzheimer's unit, was open and unattended. CMS Ex. 3, at 12; Suzanne Ray Affidavit.

b. The medication room had three containers in it labeled "pH Quat." CMS Ex. 3, at 12; Suzanne Ray Affidavit.

c. The substance pH Quat is a cleaning agent. The bottles were labeled "Harmful if Swallowed, Keep Out of Reach of Children." CMS Ex. 3, at 12; Suzanne Ray Affidavit.

d. A bottle labeled "Spray and Wipe," also with the warning "Harmful if Swallowed, Keep Out of Reach of Children," was in an unlocked utility room on C Hall. CMS Ex. 3, at 12; Suzanne Ray Affidavit.

e. There are cognitively impaired residents, who are prone to wander, living near the medication and utility rooms on C Hall. CMS Ex. 3, at 12; Suzanne Ray Affidavit.

15. Petitioner was cited for violating 42 C.F.R. � 483.25(h)(2) at the scope and severity level G. This deficiency is F Tag 324: the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. F Tag 324 is supported by facts concerning one resident:

a. On the Minimum Data Set dated May 11, 1999, Resident 5 was assessed to require extensive assistance with transfers. CMS Ex. 10, at 21.

b. Resident 5 needed the assistance of two or more persons when transferring between surfaces. CMS Ex. 10, at 21.

c. On July 17, 1999 Resident 5 weighed 167 pounds. Stipulated Fact 41.

d. On July 24, 1999 Resident 5 was transferred with a Hoyer Lift by one Certified Nursing Assistant. The Certified Nursing Assistant and Resident 5 fell to the floor during the transfer. Stipulated Fact 42.

e. When Resident 5 fell, she received a 1-1.5 cm. hematoma to the back of her head, and a skin tear to her left hand. Stipulated Fact 43.

f. The Facility's procedure for transfers requires two people to assist when transferring a resident with a Hoyer lift. Paula Smith Affidavit at 1-2.

16. Petitioner was cited for violating 42 C.F.R. � 483.25(i)(2), at the scope and severity level D. This deficiency is F Tag 326: based on a resident's comprehensive assessment, the facility must ensure that the resident receives a therapeutic diet when there is a nutritional problem. F Tag 326 is supported by facts concerning three residents:

a. Resident 6 was an alert and oriented resident. CMS Ex. 11, at 1-4.

i. The physician's orders dated August 1, 1999, indicated that Resident 6 was to receive food and snacks at liberty despite weight gain. Stipulated Fact 55.

ii. The Facility's snack chart for the 8:00 P.M. bed time snack service on August 10, 1999, did not list Resident 6 to receive a snack. Stipulated Fact 56.

b. Resident 10 was an alert and oriented resident, with a diagnosis of Insulin Dependent Diabetes Mellitus. Stipulated Fact 50.

i. Resident 10 was assessed on August 6, 1999 as being totally dependent on staff for activities of daily living, experiencing severe weight loss, and having four stage II decubiti. CMS Ex. 15, at 46-50.

ii. Resident 10's Plan of Care, dated August 6, 1999, calls for her to receive a snack. Stipulated Fact 51.

iii. The physicians' order dated August 7, 1999 calls for Resident 10 to receive three snacks per day. Stipulated Fact 52.

iv. On August 10, 1999 Resident 10 did not receive her 2:00 P.M. snack until 3:45 P.M. Stipulated Fact 53.

v. On August 10, 1999 Resident 10 drank less than half the milk served with her 2:00 P.M. snack. Stipulated Fact 54.

vi. Diabetics must control their blood sugar because high blood sugar can lead to a diabetic coma. Mary Ann Smith Affidavit at 2.

vii. One method of controlling blood sugar is to eat certain foods and to eat them in a timely manner. Mary Ann Smith Affidavit at 2.

c. Resident 11 was an alert and oriented resident with a diagnosis of Insulin Dependent Diabetes Mellitus. Stipulated Fact 44.

i. A physician's order dated August 1, 1999 ordered that Resident 11 receive a regular diet, with a bedtime snack of skim milk and graham crackers on Saturday, Monday, Wednesday and Friday; and skim milk and fruit on Tuesday, Thursday and Sunday. Stipulated Fact 45.

ii. The Minimum Data Set dated May 4, 1999 showed that Resident 11 was receiving a therapeutic diet with a supplement. Stipulated Fact 46.

iii. Resident 11's Plan of Care dated May 18, 1999 documents that Resident 11 is supposed to receive snacks. Stipulated Fact 47.

iv. The Medication Sheet for August 1, 1999-August 10, 1999, documented an unstable Capillary Blood Glucose Level ranging from 92 to 412 gm/dl. Stipulated Fact 48.

v. On August 10, 1999 Resident 11 was not on the Dietary Manager's snack list. CMS Ex. 3, at 15; Mary Ann Smith Affidavit at 2.

17. Petitioner was cited for violating 42 C.F.R. � 483.35(h)(2), at the scope and severity level E. This deficiency is F Tag 371: the facility must store, prepare, distribute and serve food under sanitary conditions. Concerning F Tag 371, on August 9, 1999, a dietary employee handled food being served to the residents using the same pair of gloves that she used to handle the food service trays and diet cards she placed on the trays. CMS Ex. 3, at 18; Mary Ann Smith Affidavit.

18. Petitioner was cited for violating 42 C.F.R. � 483.75(f), at the scope and severity level E. This deficiency is F Tag 498: the facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for resident's needs, as identified through resident assessments, and described in the plan of care. F Tag 498 is supported by facts concerning two residents:

a. On August 12, 1999 at approximately 8:25 A.M., a nurse aide was feeding Resident 1. Stipulated Fact 65.

i. The nurse aide spilled oatmeal over Resident 1's face and gown several times over the course of two minutes. Suzanne Ray Affidavit at 2-3.

b. On August 10, 1999 at approximately 4:15 P.M., a nurse aide provided incontinent care to Resident 3. Stipulated Fact 66.

i. While providing incontinent care to Resident 3, the nurse aide wiped the area soiled with urine and feces front to back, over a stage II pressure sore that had no dressing covering it. Suzanne Ray Affidavit at 3.

ii. The nurse aide used a towel smeared with loose fecal material to wipe Resident 3. Suzanne Ray Affidavit at 3.

iii. The nurse aide did not rinse the front side of Resident 3's body, which was soiled, and cleaned only the buttocks and coccyx area. Suzanne Ray Affidavit at 3.

19. Petitioner was cited for violating 42 C.F.R. � 483.75(j), at the scope and severity level D. This deficiency is F Tag 502: the facility must provide or obtain laboratory services to meet the needs of its residents. And, the facility is responsible for the quality and timeliness of the services. F Tag 502 is supported by facts concerning two residents:

a. See Finding of Fact 12a-e, concerning Resident 5.

b. Resident 7 had a physician's order for Prothrombin Time to be drawn every month. Stipulated Fact 67.

i. The Prothrombin Time drawn on June 28, 1999 was abnormal. Stipulated Fact 68.

ii. It is necessary to check the Prothrombin level to determine the amount of time needed for blood to clot. Prothrombin causes blood to clot. Suzanne Ray Affidavit at 3.

iii. The physician changed Resident 7's dosage of Coumadin. Stipulated Fact 69.

iv. A second Prothrombin Time was ordered and drawn on July 7, 1999. Stipulated Fact 70.

v. As of 11:00 A.M. on August 17, 1999, there were no Prothrombin Time results in the clinical record, and there was no documentation in the lab book that the Prothrombin Time test had been drawn for the monthly value due August 7, 1999. Stipulated Fact 71.

20. Petitioner was cited for violating 42 C.F.R. � 483.75(j)(2)(ii), at the scope and severity level G. This deficiency is F Tag 505: the facility must provide or obtain laboratory services only when ordered by the attending physician, and promptly notify the attending physician of the findings. F Tag 505 is supported by facts concerning Resident 17:

a. Resident 17 had diagnoses of Insulin Dependent Diabetes Mellitus, Dementia of Alzheimer's Type, and Coronary Heart Disease. Stipulated Fact 72.

b. On November 10, 1998, Resident 17 was assessed as cognitively impaired and rarely able to understand or be understood. Stipulated Fact 73.

c. Resident 17 had a physician's order for a "fasting blood sugar test" to be done monthly. Stipulated Fact 74.

d. The fasting blood sugar test done on July 15, 1999 yielded a reading of 55. Normal values are between 70-110. Stipulated Fact 75.

e. The test results from the July 15, 1999 test were received, timed, and noted by the nurse on July 16, 1999. Stipulated Fact 76.

f. As of August 13, 1999 the Director of Nurses could find no documentation that the Facility had notified Resident 17's physician of the results of the July 15, 1999 fasting blood sugar test results. Stipulated Fact 77.

g. On July 22, 1999 at 5:10 P.M. Resident 17 was unresponsive and his skin was moist and cool. Accuchecks were done two times and both times they read low. Stipulated Fact 78; CMS Ex. 19, at 19.

h. The physician ordered that Glucagon 1mg. be immediately given to Resident 17, intramuscularly. Stipulated Fact 79.

i. Glucagon is used in the emergency treatment of severe hypoglycemic reactions in diabetic patients who are unconscious or unable to swallow food or liquid. Stipulated Fact 80.

j. Petitioner notified Resident 17's physician of the change in his condition on July 22, 1999. CMS Ex. 19, at 19.

21. Petitioner was cited for violating 42 C.F.R. � 483.75(l)(1), at the scope and severity level D. This deficiency is F Tag 514: the facility must maintain clinical records on each resident in accordance with accepted professional standards and practices; and ensure that the records are complete, accurately documented, readily accessible and systematically organized. F Tag 514 is supported by facts concerning two residents:

a. Resident 4 had a physician's order dated May 29, 1999 and August 1, 1999 for a geri chair without tray table. Stipulated Fact 83.

i. Resident 4 had a consent form dated August 1, 1999, signed by his wife, for a geri chair with tray table. Stipulated Fact 84.

b. Resident 10 had a physician's order dated August 7, 1999 to take Resident 10's pulse oximetry daily three times, and to give oxygen at two liters per nasal cannula for pulse ox less than 90. Stipulated Fact 82.

i. The Medication Administration Record did not have documentation for Resident 10's pulse oximetry on August 9, 1999. Stipulated Fact 82.

III. Conclusions of Law

1. Petitioner violated 42 C.F.R. � 483.70(f), F Tag 463, at a scope and severity level K (a pattern of immediate jeopardy), because the Facility failed to ensure that the nurse's station was equipped to receive resident calls through a communication system from resident rooms, and toilet and bathing facilities. The Facility's call light system was in a state of disrepair from July 29-August 10, 1999. During that period there was no alternate communication system in place. Furthermore, CMS's determination that the Facility placed Residents 3, 10 and other residents in immediate jeopardy is not clearly erroneous, because the residents were vulnerable, infirm persons to whom the inability to communicate easily with the nurse's station was likely to cause serious injury, harm, impairment or death.

2. Petitioner violated 42 C.F.R. � 490.75, F Tag 490, at a scope and severity level K (a pattern of immediate jeopardy), because when the call light system failed the Facility did not develop and implement appropriate plans of action to fix it. Furthermore, CMS's determination that the Facility placed Residents 3, 10 and other residents in immediate jeopardy is not clearly erroneous, because the residents were vulnerable, infirm persons to whom the inability to communicate easily with the nurse's station was likely to cause serious injury, harm, impairment or death.

3. Petitioner violated 42 C.F.R. � 483.75(o)(2), F Tag 521, at the scope and severity level K (a pattern of immediate jeopardy), because the Facility's Quality Assessment and Assurance Committee did not identify the failure of the call light system as an issue that required quality assessment and assurance activities. And the committee failed to develop and implement appropriate plans of action to fix the call light system. Furthermore, CMS's determination that the Facility placed Residents 3, 10 and other residents in immediate jeopardy is not clearly erroneous, because the residents were vulnerable, infirm persons to whom the inability to communicate easily with the nurse's station was likely to cause serious injury, harm, impairment or death.

4. Petitioner violated 42 C.F.R.� 483.10(b)(11)(i)(B), F Tag 157, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because there were significant changes in the status of pressure sores on Residents 13, 18, and 19, and the Facility failed to timely notify their physicians and families.

5. Petitioner violated 42 C.F.R. � 483.10(f)(2), F Tag 166, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility failed to resolve Resident 10's grievance that the call lights in her bathroom and room were broken.

6. Petitioner violated 42 C.F.R. � 483.15(a), F Tag 241, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility failed to maintain a resident's dignity by administering medicine to the resident while the resident sat on the toilet, in a bathroom that stank of feces.

7. Petitioner violated 42 C.F.R. � 483.20(b)(2)(ii), F Tag 274, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility failed to conduct a comprehensive assessment of Resident 5 after Resident 5 developed a stage II pressure sore and experienced a significant change in continence.

8. Petitioner violated 42 C.F.R. � 483.20(b)(2)(iii), F Tag 275, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility did not conduct a comprehensive assessment of Resident 19 in for the year 1998.

9. Petitioner violated 42 C.F.R. � 483.20(k)(3)(ii), F Tag 282, at the scope and severity level G (an isolated instance of actual harm, but not immediate jeopardy), because the Facility failed to follow a physician's order that specified tests be done for Resident 5.

10. Petitioner violated 42 C.F.R. � 483.25(c), F Tag 314, at the scope and severity level H (a pattern of actual harm, but not immediate jeopardy), because the Facility failed to ensure that Residents 1, 2, 4, 8, 10, 13, and 19, who were at risk for pressure sores, received the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

11. Petitioner violated 42 C.F.R. � 483.25(h)(1), F Tag 323, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility failed to adequately safeguard cognitively impaired residents who lived on or near C Hall, by leaving hazardous cleaning substances in unlocked rooms and accessible containers.

12. Petitioner violated 42 C.F.R. � 483.25(h)(2), F Tag 324, at scope and severity level G (an isolated instance of actual harm that is not immediate jeopardy), because the Facility did not provide two persons to transfer Resident 5 from surface to surface, as required by Resident 5's assessment.

13. Petitioner violated 42 C.F.R. � 483.25(i)(2), F Tag 326, at the scope and severity level D (an isolated instance of actual harm with the potential for more then minimal harm, but not immediate jeopardy), because Residents 10 and 11 were not provided snacks in accordance with physician's orders, as part their therapeutic diets.

14. Petitioner violated 42 C.F.R. � 483.35(h)(2), F Tag 371, at the scope and severity level E (a pattern of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility's employee handled food being served to the residents and food service items in an unsanitary manner.

15. Petitioner violated 42 C.F.R. � 483.75(f), F Tag 498, at the scope and severity level E (a pattern of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because a nurse aide was unable to demonstrate competency in the skills required to feed Resident 5; and a nurse's aide was unable to demonstrate competency in the skills and techniques necessary to provide incontinence care to Resident 3.

16. Petitioner violated 42 C.F.R. � 483.75(j)(l), F Tag 502, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility failed to appropriately provide laboratory services to residents 5 and 7, in accordance with physicians' orders.

17. Petitioner violated 42 C.F.R. � 483.75(j)(2)(ii), F Tag 505 (erroneously cited by CMS in the statement of deficiencies (CMS Ex. 3) as F Tag 514), at the scope and severity level G (an isolated instance of actual harm that is not immediate jeopardy), because the Facility failed to promptly notify Resident 17's physician of the results of a fasting blood sugar test that showed a change in Resident 17's condition.

18. Petitioner violated 42 C.F.R. � 483.75(l)(1), F Tag 514, at the scope and severity level D (an isolated instance of no actual harm with the potential for more then minimal harm, but not immediate jeopardy), because the Facility failed to keep and maintain complete and accurately documented records on residents 4 and 10.

19. There is a basis for the imposition of CMPs from July 29, 1999-August 10, 1999; and August 11, 1999-September, 29, 1999.

20. The CMP amount, $5,050 per day, for the period when immediate jeopardy existed in the Facility, July 29, 1999-August 10, 1999, is reasonable.

21. The CMP amount, $150 per day, for the period when the Facility did not substantially comply with participation requirements (but at less than the immediate jeopardy level), August 11, 1999-September, 29, 1999, is reasonable.

IV. Analysis

A. Issues Presented

1. Whether there is a basis for CMS to impose CMPs; i.e., whether Petitioner substantially complied with the requirements for participation in the Medicare and Medicaid programs.

2. If there is a basis for CMS to impose CMPs, whether the amounts of the CMPs are reasonable.

B. Governing Law

Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act (Act) (42 U.S.C. �� 301-1397jj) set forth requirements for long-term care facilities, both skilled nursing facilities and nursing facilities, participating in the Medicare and Medicaid programs, and authorize the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819, 1919. The Secretary's regulations governing skilled nursing facility and nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

If CMS finds a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing CMPs. See Act, section 1819(h). CMS is authorized to assess CMPs when a facility is not in compliance with one or more participation requirements. 42 C.F.R. � 488.430(a). The CMPs range from $50 to $3,000 per day for deficiencies that do not constitute immediate jeopardy, but either cause actual harm, or cause no actual harm, but have the potential for causing more than minimal harm. And, the CMPs range from $3,050 to $10,000 per day for deficiencies which constitute immediate jeopardy. 42 C.F.R. � 488.438(a)(i) and (ii).

The purpose of the authorized remedies is to "ensure prompt compliance with program requirements." 42 C.F.R. � 488.402(a). The remedies are applied in light of the scope and severity of the noncompliance found during a survey. In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. � 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. � 488.438(f). The factors found at 42 C.F.R. � 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, specifically with reference to the cited deficiencies.

When CMS imposes an enforcement remedy on a skilled nursing facility or nursing facility, the facility has a right to appeal the "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), 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing remedies. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP CMS could collect or affect the facility's nurse's aide training program. 42 C.F.R. � 498.3(b)(14).

CMS's determination regarding the level of noncompliance must be upheld unless clearly erroneous. 42 C.F.R. � 498.60(c)(2). This includes instances where CMS has determined that the level of noncompliance is at the immediate jeopardy level. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000).

In this case, Petitioner has appealed CMS's findings of noncompliance with the following program requirements:

42 C.F.R. � 483.70(f) (F Tag 463). This requires that: the nurse's station must be equipped to receive resident calls through a communication system from resident rooms, and toilet and bathing facilities.

42 C.F.R. � 490.75 (F Tag 490). This requires that the facility develop and implement appropriate plans of action to correct identified quality deficiencies.

42 C.F.R. � 483.75(o)(2) (F Tag 521). This requires that the facility's quality assessment and assurance committee meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary. And that the committee develops and implements appropriate plans of action to correct identified quality deficiencies.

42 C.F.R. � 483.10(b)(11)(i)(B) (F Tag 157). This requires that a facility must immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or an interested family member when there is a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications).

42 C.F.R. � 483.10(f)(2) (F Tag 166). This provides: a resident has the right to prompt efforts by the facility to resolve grievances the resident may have, including those with respect to the behavior of other residents.

42 C.F.R. � 483.15(a) (F Tag 241). This requires that the facility must promote care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect in full recognition of his or her individuality.

42 C.F.R. � 483.20(b)(2)(ii) (F Tag 274). This requires that a facility must conduct a comprehensive assessment of a resident within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. (For purposes of this section, a "significant change" means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan, or both.)

42 C.F.R. � 483.20(b)(2)(iii) (F Tag 275). This requires that a facility must conduct a comprehensive assessment of a resident not less often than once every 12 months.

42 C.F.R. � 483.20(k)(3)(ii) (F Tag 282). This requires that the services provided or arranged by the facility must be provided by qualified persons in accordance with each resident's written plan of care.

42 C.F.R. � 483.25(c) (F Tag 314). This requires the facility to ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable. And, a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. � 483.25(h)(1) (F Tag 323). This requires the facility to ensure that the resident environment remains as free of accident hazards as is possible.

42 C.F.R. � 483.25(h)(2) (F Tag 324). This requires the facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. � 483.25(i)(2) (F Tag 326). This requires that based on a resident's comprehensive assessment, the facility must ensure that a resident receives a therapeutic diet when there is a nutritional problem.

42 C.F.R. � 483.35(h)(2) (F Tag 371). This requires that the facility must store, prepare, distribute, and serve food under sanitary conditions.

42 C.F.R. � 483.75(f) (F Tag 498). This requires the facility ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.

42 C.F.R. � 483.75(j)(l) (F Tag 502). This requires that the facility must provide or obtain laboratory services to meet the needs of its residents. And, the facility is responsible for the quality and timeliness of the services.

42 C.F.R. � 483.75(j)(2)(ii) (F Tag 505). This requires that the facility provide or obtain laboratory services only when ordered by the attending physician and promptly notify the attending physician of the findings.

42 C.F.R. � 483.75(l)(1) (F Tag 514). This requires that the facility maintain clinical records on each resident in accordance with accepted professional standards and practices. And, that the records are complete, accurately documented, readily accessible and systematically organized.

CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); see also Cross Creek Health Care Center, DAB No. 1665 (1998) (framework allocating the burden of proof provided in Hillman applies in appeals of CMPs).

C. Discussion

1. Deficiencies cited at the immediate jeopardy level of scope and severity.

a. F Tag 463

I find that the Facility failed to substantially comply with the requirement, provided by 42 C.F.R. � 483.70(f), that the nurse's station must be equipped to receive resident calls through a communication system from resident rooms and toilet and bathing facilities.

CMS presented a prima facie case that the Facility failed to substantially comply with this requirement at the immediate jeopardy level. And, after reviewing the evidence and argument presented by Petitioner, I find that Petitioner has neither overcome CMS's prima facie case by a preponderance of the evidence, nor demonstrated that CMS's assignment of the immediate jeopardy level of scope and severity to the deficiency is clearly erroneous. CMS presents a persuasive case that the Facility's call light system was malfunctioning and unreliable, and that the Facility failed to take appropriate steps to address the problem. Therefore, the Facility failed to provide the residents with a viable communication system as required by section 483.70(f). CMS demonstrated how this failure resulted in immediate jeopardy to residents. Petitioner's rejoinder, that the Facility had a reasonable back-up to the call light system and the residents were not placed in immediate jeopardy, is not supported by the facts.

CMS has demonstrated that the Facility had a malfunctioning call light system, and that the call light system, if not continuously 100% inoperable, had been malfunctioning since at least July 29, 1999. The evidence shows that: the call light system was broken in certain residents' rooms and in a section of the Facility; the Facility knew the call light system had been broken for a period of time; the Facility had no alternative communication system in place; and that Residents 3, 10 and other residents were placed in immediate jeopardy by the Facility's failure to substantially comply with the communication system requirement. Specifically, the call lights were shown to be broken in Room 16B on B Hall (Resident 3's room) on August 10, 1999. CMS Ex. 15, at 11. The call lights were not functioning properly in rooms 32 and 34 on B Hall on that same day. CMS Ex. 25, at 16; Karol Burrow Affidavit at 3. It was demonstrated that the Facility knew about the problem for a period of time because the Maintenance Supervisor indicated that the call light system had been malfunctioning since July 29, 1999, and Resident 10 complained that the call lights in her room and bathroom were broken on August 9, 1999. CMS Ex. 15, at 4, 11; P. Ex. 121; Karol Burrow Affidavit at 3-4.

Furthermore, this failure was compounded by the lack of an alternate communication system. The Facility apparently believed it was sufficient, in the absence of a working call light system, to check on residents every two hours. ⁽²⁾ CMS Ex. 25, at 18. And, it was not until the surveyors emphasized the problem to the Facility's staff, on August 10, 1999, that cowbells were provided to the residents as an alternative means of signaling for help; and a policy was instituted in case of the call light system's failure. CMS Ex. 22.

Moreover, during this period when the call light system was not working, the evidence shows that Resident 3 and Resident 10 were in immediate jeopardy due to the nature of their medical conditions. Resident 3 had suffered a Cerebral Vascular Accident and was totally dependent on the staff. Stipulated Fact 63. Additionally, Resident 3 was aphasic, a condition that can affect the ability to call for help. Stipulated Fact 64; Karol Burrow Affidavit at 3. The potential consequences for this Resident in being unable to summon help for two hour blocks at a time are obvious. Similarly, Resident 10 had diagnoses of numerous serious ailments including Cerebral Vascular Accident and Congestive Heart Failure. Stipulated Fact 58. Resident 10 also required assistance from staff, including assistance to walk in her room and go to the toilet. CMS Ex. 15, at 47. The potential consequences for this Resident's being unable to summon help for long periods of time are similarly obvious. And the evidence is substantial that the call light system failure constituted a pattern which jeopardized the health and safety of other residents. I find these facts sufficient to constitute a prima facie case that Petitioner was out of substantial compliance with the requirement that facilities provide a communication system from resident rooms and bathrooms to the nurse's station. And, I find that it is not clearly erroneous for CMS to have determined that the deficiency was likely to cause serious injury, harm, impairment or death to residents.

The essence of Petitioner's arguments in response to CMS are:

(1) CMS's finding of a deficiency is outside the scope of its authority because the regulation does not call for the evaluation of Petitioner's alternate method of providing a communication system;

(2) Petitioner moved expeditiously to fix the call light system;

(3) The residents were not in immediate jeopardy because Petitioner had instituted a system of periodically checking on the residents and the residents could call for assistance without a call light system; and

(4) The period of immediate jeopardy was erroneously set by CMS from July 29, 1999-August 10, 1999, because the call light system worked some of the time.

Petitioner presented these arguments in its brief at pages 2-21 as a single passage. For convenience, I have designated the separate threads of Petitioner's argument as these four separate ones, and I address them in that order.

First, Petitioner asserts that CMS exceeded the scope of its authority by evaluating the effectiveness of the Facility's "alternate communication system" (checking on residents every two hours). Petitioner reasons that the regulation requires that a Facility have a communication system, but it does not explicitly authorize CMS to consider the effectiveness of the communication system. As discussed above, the Facility's communication system was a call light system. When activated by a resident, the call light system would cause a light in the hallway above each resident's room to light, and another light on a panel light board at each nurse's station to light and buzz. Stipulated Fact 94. Petitioner opined that a reasonable interpretation of the regulation is that, if the communication system is not working, "it would be the responsibility of the Facility to put in place an alternative method for assuring communication with the resident from their room or in toileting and bathing areas." Petitioner's Brief at 4. And, Petitioner concedes that "[t]he Facility documentation indicated the problem with the electronic call light and buzzer system existed on and off from July 29, 1999 through August 10, 1999." Petitioner's Brief at 5. Petitioner further indicates that the Facility had sought to have a vendor repair the call light system, but ultimately determined to purchase a new system because eight rooms on B North Hall had "various types of malfunctioning call light problems." Petitioner's Brief at 9. Petitioner explained that because of the unreliability of the electronic call light system, it instituted a system of checking on the residents. Petitioner's Brief at 10. Petitioner argues that these checks were an acceptable alternative communication system, and that CMS's determination that it was not acceptable is "inconsistent with the federal regulation and in excess of their [CMS's] legal authority." Petitioner's Brief at 11. It is Petitioner's position that the regulation does not provide authority for CMS to evaluate the effectiveness of the "alternate method" the Facility implemented when its call light system was out of service. Petitioner's Brief at 4. Petitioner asserts that:

Proof that a Facility's alternate method is not in fact a substitute system must be first borne by the State Survey Agency and set forth in their Statement of Deficiencies; and then secondly, factually demonstrate the attempt by a resident to communicate with the nurse's station that failed.

Id. I find, however, that Petitioner miscasts what is being assessed and what the regulation requires. It is appropriate for CMS to consider whether there was a communication system in place that allowed the residents to communicate with the nurses' stations. I interpret section 483.70(f) to require that the communication system, whatever it is, ⁽³⁾ must be effective and reliable, i.e. it must work, because if section 483.70(f) does not require a communication system to be effective and reliable, it has no health and safety purpose. Whether the communication system is an alternate method or a substitute system is irrelevant. The communication system works or it does not. It works when, and only when, residents and staff can rely on it dependably to convey messages that may range at random from the trivial to the critical, from the casual to the urgent. If residents cannot be confident that their efforts to communicate with staff are being transmitted with a very high degree of regularity, the system does not work. And unless the staff can be certain that residents' communications are reaching them with a very high degree of regularity, the system does not work. It is CMS's proper role to determine not just whether a system exists, but whether it is effective and reliable. To hold that the regulation only allows CMS to verify whether a communication system exists, but not to evaluate its effectiveness, is contrary to the broader purpose of the regulation: to have facilities designed, constructed and equipped to protect the health and safety of the residents. 42 C.F.R. � 483.70. A communication system that does not work cannot protect the health and safety of the residents. Thus, I find Petitioner's argument that CMS has exceeded its authority unpersuasive.

Next, Petitioner presents the argument that it took the necessary steps to address the malfunctioning call light system. Petitioner explains that:

[i]t was indicated [by Facility staff to the surveyors] that the system call lights worked one day and the next day they don't work . . . [t]his confirms that on and off nature of the malfunction, but also the fact that repairs were being done consistently.

Petitioner's Brief at 9. It is not entirely clear from Petitioner's Brief, but perhaps it is Petitioner's point, that it was justified in using the two hour checks as a back up, because the Facility could not comprehend that the call light system was completely unreliable until it had attempted to fix it several times and failed. I find, however, that evidence that the Facility made prompt and serious efforts to fix the call light is scant. In fact, I conclude that the Facility's approach to dealing with the problem seems to have been lackadaisical.

Repairs Petitioner claims were being "done consistently" were in fact sporadic. The Facility knew the call light system was not working properly on July 29, 1999. But there is no indication what, if anything, was done to correct the problem until six days later on August 4, 1999, when a call was placed to a service technician, and one other call (before the surveyors brought the problem to the Facility's attention on August 10, 1999), on August 6, 1999. P. Ex. 9, at 1-2. The alternate system of checking on residents at two hour intervals was not instituted until August 5, 1999. P. Ex. 8. The fact that these checks were not even begun until five days after the Facility was aware there were problems with the call light system demonstrates that the Facility's approach lacked the alacrity called for when dealing with this compromise of the health and safety of the residents.

The regulation requires a system for communication between residents in their rooms and bathrooms and the nurses' stations. For the requirement to be meaningful, a communication system must be effective and reliable for conveying messages or signals from the residents to the staff. In this case, neither the frequently malfunctioning call light system, nor the implementation of resident checks at two hour intervals, comprises an effective and reliable system for conveying messages from residents to staff. Arguably, a Facility could be substantially compliant with section 483.70(f) if its call light system malfunctioned or was shut down for maintenance, and the Facility took appropriate measures to assure the health and safety of the residents. But, the call light or other communication system, while it may frequently be used to summon routine assistance, is also an emergency communication device. Vulnerable residents may have to rely on the system to call for emergency assistance--and they may not have an hour or two to wait. Accordingly, maintenance of the communication system must be a high priority and the continued safety of the residents must be assured during its incapacitation. The facts show that the Facility did not make prompt efforts to fix the system, appropriate to the systems important safety function.

Petitioner argued also that the residents generally, and specifically residents 3 and 10, were not in immediate jeopardy because the Facility's staff was checking on the residents, and the residents were capable of verbalizing requests for assistance without a call light system. Petitioner stresses that the Facility was adequately staffed on August 10, 1999 to buttress Petitioner's contention that the residents were being monitored. Petitioner's Brief at 8.

Concerning Resident 3, Petitioner argues that it is "pure speculation" on the part of CMS that Resident 3 was at risk for harm due to the malfunctioning call light system. Petitioner's Brief at 16. And, Petitioner argues that it was not proven Resident 3 was unable to verbalize requests for assistance. Id. I disagree with Petitioner's assessment. I find that the Resident's malfunctioning call light system, coupled with the resident's serious diagnoses and incapacitation, placed Resident 3's health and safety in immediate jeopardy. As I discussed above, Resident 3 was totally dependent on the staff and was aphasic, a condition that can affect the ability to call for help. It is also established that this resident's health history made it likely that the resident would suffer a medical emergency. Without the call light system, it is likely that this resident would have an emergency and be unable to summon help. Under the Facility's checking system, Resident 3 is likely to have been waiting up to two hours for assistance.

Concerning Resident 10, Petitioner argues that is an "inconsistent position" that Resident 10 was at risk. Petitioner reasons that Resident 10 maintained too active a schedule to need to communicate with the nurse's station. For instance, Resident 10 needed oxygen monitoring, had medical tests and treatment scheduled during the day, and took meals in the dining room. Petitioner concludes that Resident 10's interaction with the staff precluded immediate jeopardy. Petitioners Brief at 13. Moreover, Petitioner argues, Resident 10 could communicate without the call light system. Petitioner's Brief at 14. Petitioner interprets the incident when Resident 10's son (who shared her room) fell on the floor and was discovered by a nurse's assistant, to show that the checks at two hour intervals were working. Petitioner's Brief at 15.

I disagree with Petitioner's arguments concerning Resident 10 as well. The reason immediate jeopardy arises in this case is that these are infirm nursing home residents. The fact that Resident 10 interacted with staff and was capable of communication does not diminish this fact. Like Resident 3, this resident was likely to suffer a medical emergency and need to summon assistance--at that moment she may not be able to verbalize her need, even if she normally can. Concerning the incident where Resident 10's son fell and was discovered by a nurse's assistant, this does not show, as Petitioner argues, that the checking system was working. What is telling is that the nurse's assistant left the room to summon help, leaving the fallen resident unattended. It is true that Resident 10's son falling is not an indication of deficient practice. However, it emphasizes the likelihood of serious injury, harm, impairment or death to a resident who is unable to promptly summon help. And, while Petitioner correctly observed that the fallen resident may not have been able to use a call light in that situation anyway, the incident nonetheless serves to underscore that these are common problems for nursing home residents. There are any number of possible situations where these vulnerable residents need to summon help in an emergency, and they need to rely on an effective communication system to do so. Concerning the system of checks, the ineffectiveness of this approach is inherent in the difference between waiting two hours and being able to press a button and summon help immediately. Checks by staff on residents at two hour intervals is not a sufficient communication system.

Petitioners final argument concerning F Tag 463 is that "[t]he State Survey Agency investigation fails to document with certainty that the Facility had failed to maintain a call light system from August 10, 1999 back to July 29, 1999." Petitioner's Brief at 20. Petitioner's argument rests on its claim that CMS's evidence does not establish that the call light system was entirely inoperable from July 29, 1999 to August 10, 1999. Petitioner's Brief at 13. Presumably, Petitioner believes that the residents were not in jeopardy during these alleged periods. In an effort to show the call light system worked some of the time, Petitioner explains "[n]ot all rooms were totally without a call light system, but rather a malfunction may be a bad call light, or a light that does not light up, or a nursing panel light out" and "[t]here is no evidence to indicate the call light system had malfunctioned between August 6, 1999 and August 9, 1999." Petitioner's Brief at 9-10. But, Petitioner concedes that it was aware that its "old" call light system periodically malfunctioned, and that it had been attempting to repair the system from July, 1999 to the time of the survey. Petitioner's Brief at 19. And, Petitioner acknowledges that "it was known to the Administrator that [sic] the uncertainty of an electronic call system working on B North Hall." Petitioner's Brief at 10. Furthermore, as I discussed above, Petitioner conceded that the call light system was unreliable and that it would work one day and not the next. Petitioner's Brief at 9. Additionally, two staff members, the Maintenance Supervisor and Laundry Supervisor, mentioned July 29, 1999 as the date they were aware there was a problem with the call light system. ⁽⁴⁾ P. Ex. 121; Petitioner's Brief at 11. Moreover, explaining why the system of checking on residents was instituted on August 5, 1999, Petitioner states: ". . . the Administrator had placed into effect an alternate system to assure the residents' ability to communicate to the nurse's station beginning August 5, 1999." Petitioner's Brief at 10. This confirms that the call light system was ineffective. Consequently, I find that the unsubstantiated contention that the call light system may have worked partially, or intermittently, is unpersuasive to show that the Facility did provide an effective communication system or that the residents' health and safety was not in jeopardy. The facts establish that the period the residents were in immediate jeopardy, because there was no adequate or reliable communication system in place, is from July 29, 1999 to August 10, 1999.

b. F Tag 490

CMS has presented a prima facie case that the Facility failed to develop and implement appropriate measures to address the broken call light system. Petitioner neither convinced me that it was substantially compliant by a preponderance of the evidence, nor showed that CMS's determination that the deficiency was at the immediate jeopardy level of scope and severity was clearly erroneous.

42 C.F.R. � 483.75 requires that the Facility develop and implement appropriate plans of action to correct identified quality deficiencies. CMS presented evidence that the Facility's Administrator, the Director of Nurses, and the Maintenance Supervisor were aware, during the period of immediate jeopardy, that the call light system was not working. Karol Burrow Affidavit; CMS Ex 25. The Facility's Maintenance Supervisor acknowledged that the Facility knew of the problems with the system on July 29, 1999. CMS Ex. 15, at 11; CMS Ex. 25; Karol Burrow Affidavit at 3-4; Paula Smith Affidavit at 2-3. Yet, there was no procedure put in place in anticipation of the failure of the call light system. And, the Facility had no alternate communication system. Karol Burrow Affidavit; CMS Ex. 25, at 18. It was not until August 10, 1999, after the surveyors uncovered the deficiency, that the Facility provided cowbells to the residents, and instituted a policy to be followed in case of a call light system failure. CMS Ex. 22. Thus, the evidence shows that after July 29, 1999, the Facility had not developed and implemented an appropriate plan to deal with the failure of the call light system.

Petitioner's response to CMS's argument is to repeat its contention that section 483.70(f) requires the Facility to maintain communication equipment at the nurse's station, but that there is "no degree or measurement of effectiveness attached." Petitioner's Brief at 22. Petitioner argues that its alternate communication system, checking on residents every two hours, was more likely to work than distributing cowbells to the 14 residents of B Hall. Petitioner's Brief at 23. Petitioner contends that, in not accepting its policy of checking on residents as an acceptable response to the broken call light system, CMS acted beyond its authority to find a deficiency, because it substituted its judgment for the Facility's.

As I indicated in the discussion of F Tag 463 (above), Petitioner is mistaken that CMS acted outside the scope of its authority, because its assessment of whether a facility has a communication system must take into account whether the system works. Section 483.75 requires an appropriate plan to address and correct a substantive deficiency. The Facility's system of checking residents every two hours is not such an appropriate plan. The substantive deficiency is the failure to provide an effective call light system by fixing or replacing the ineffective call light system, or providing some other effective system. The broken call light system was not addressed, but the Facility argues that instituting checks at two hour intervals is an adequate communication system. I find that checking on residents at two hour intervals is not an appropriate plan of action to deal with a broken call light system. An appropriate plan of action would be to repair the call light system or to replace it with a similar communication system--a system that provides instantaneous communication between resident rooms and bathrooms and the nurse's station. Checking on residents in their rooms does not provide communication between resident rooms and bathrooms and the nurse's station, and it is not similar to a communication system which does. In fact, it would be impossible for a facility to provide most of the care required by part 483 if the staff did not check on residents, because providing the care necessitates going to the residents and seeing them, i.e., checking on them. Hence, the notion that checking on the residents every two hours is a safeguard that can be substituted for a button operated call light system is illusory. It is dubious that the checks provided any significant increase in service and protection over what residents would have received without the checks.

Based on the evidence, I conclude that the Facility failed to repair or replace the call light system timely; the system of checking on residents at two hour intervals did not address or correct the lack of a communication system; and it was not until the surveyors revealed the deficiency that the Facility took the provisional step of providing residents with cow bells. Thus, I conclude that Petitioner failed to overcome, by a preponderance of the evidence, CMS's prima facie case that the Facility failed to develop and implement an appropriate plan to address the failure of the call light system. And, furthermore, it is not clearly erroneous that this failure was likely to cause serious injury, harm, impairment or death to residents. I discussed the threat to the residents in my discussion of F Tag 463 (above), where I addressed the potential consequences to the residents of being without the call light system or an acceptable substitute.

c. F Tag 521

CMS presented a prima facie case that the Facility's "Quality Assessment and Assurance Committee" failed to meet and identify the broken call light system as a quality assessment and assurance issue to be planned for and corrected. Petitioner's response is essentially that the Facility was not required to hold a meeting to address the call light system, because it had held a meeting on July 27, 1999, and, therefore, no meeting was necessary until the next quarter. The facts are not disputed, and I find that they suppport CMS's prima facie case that the Facility failed to comply with section 483.75(o)(2) and (3). Moreover, Petitioner's interpretation of its obligation under the regulation is incorrect.

42 C.F.R. � 483.75(o)(2) and (3) requires that the quality assessment and assurance committee meet at least quarterly to identify problems and decide which quality assessment and assurance activities are needed. And, it requires that the committee develop and implement appropriate plans of action to correct identified quality deficiencies. This deficiency was cited because the Facility failed to convene a quality assurance meeting to discuss the failure of the call light system and a plan of action to address that failure. The evidence shows that the Facility held a quality assurance committee meeting on July 27, 1999, but records from that meeting show that the deficient call light system was not addressed. Suzanne Ray Affidavit at 3. No meetings where held after the call light system failure became evident on July 29, 1999. CMS Ex. 26, at 15. This evidence constitutes a prima facie case that the Facility failed to identify the call light system failure as a quality assessment issue, and failed to develop an appropriate plan of action to address this deficiency.

In response, Petitioner argues that quality assurance committee meetings were held by the Facility in February, March, April, May, July, August, October and November of 1999. Petitioner's Brief at 24; P. Ex. 12. According to Petitioner, the quality assurance committee would not have considered the call light system failure in July, 1999, as a system problem that required a plan of correction. Petitioner's Brief at 25. Because section 483.75(o)(2) and (3) provides that the quality assurance committee is required to meet at least quarterly, Petitioner argues that it had fulfilled its obligation to hold a quarterly meeting and it did not need to hold an additional meeting after July 27, 1999, because it addressed the broken call light system sufficiently well without a meeting. Petitioner contends that a quality assurance note (see P. Ex. 12, at 60), shows that the call light system was addressed at a quality assurance meeting on August 26, 1999, but that, before then, the call light system problems were not yet a quality assurance issue. Petitioner's Brief at 26. Petitioner contends that between July 19, 1999 and August 26, 1999, the issue was appropriately addressed by tasking the Maintenance Director to fix the call light system. Id.

I find that Petitioner was required to hold a quality assurance meeting to address the broken call light system after the problems were discovered on July 29, 1999. Section 483.75(o)(2) and (3) is not satisfied by the mere holding of quarterly meetings. The purpose of the committee meeting is to address quality assurance issues when it is necessary. While this may be as infrequently as once per quarter, if that is all that is required to address quality assurance issues, or if there are no quality assurance issues, a facility is not relieved of its duty to hold additional meetings as necessary (i.e., if quality deficiency issues arise between quarterly meetings). It is not disputed that the Facility failed to hold a meeting to address the failure of the call light system. And, as I discussed concerning F Tags 463 and 490 (above) the failure of the call light system is a quality deficiency that was not adequately addressed by the Facility's efforts to fix the system. Therefore, it was the Facility's obligation to identify the deficiency and hold a quality assurance committee meeting to address the deficiency. Furthermore, it is not clearly erroneous that the failure to comply with section 483.75(o)(2) and (3) should have been assessed at the immediate jeopardy level of scope and severity, for the same reasons I discussed in F Tags 463 and 490 (above).

2. Deficiencies cited below the immediate jeopardy level of scope and severity.

After reviewing the parties submissions, I note that Petitioner has not offered any argument or evidence to refute these findings of noncompliance. Therefore, the question for me to decide is: Did CMS present a prima facie case that Petitioner failed to comply with the regulatory requirements in each instance? Black's Law Dictionary 825 (6^th ed. 1991) provides several definitions of "prima facie case," one of which is sufficient: "[a] case which has proceeded upon sufficient proof to that stage where it will support finding if evidence to contrary is disregarded." I find that CMS has presented a prima facie case, that Petitioner has let stand, in each instance, as explained in detail below.

a. F Tag 157

CMS presented evidence, constituting a prima facie case, that the Facility failed to make proper notification for several residents after they experienced a significant change in their health concerning pressure sores. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.10(b)(11)(i)(B) requires that the Facility must immediately inform the resident; consult with the resident's physician; and, if known, notify the resident's legal representative or an interested family member when there is a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications).

The Facility's policy indicates that the emergence of a pressure sore is a significant change. In addition to the regulatory requirement, the Facility's procedures call for the notification of a resident's family and physician within 24 hours of a significant change. CMS Ex. 28, at 8-9; Stipulated Fact 2. Yet the Facility failed to make the notifications timely.

The record shows that Resident 13 developed a pressure sore that was noted by Facility staff on August 7, 1999, but Resident 13's physician was not notified until August 12, 1999, and Resident 13's family was not notified until August 13, 1999. CMS Ex. 18, at 7, 11. Additionally, there was a pressure sore detected on Resident 18's scrotum on August 6, 1999, but the Facility's records show no indication that Resident 18's family was notified. Stipulated Facts 6-7. Similarly, on July 28, 1999, the Facility received a physician's order to treat an excoriated area on Resident 19's body. But, the Facility failed to notify Resident 19's family of this change in condition. By August 12, 1999 the excoriated area was a stage II pressure sore; yet, as of August 17, 1999, there was no documentation that the Facility notified Resident 19's physician or family of the change. Stipulated Facts 8-10; CMS Ex. 3, at 17; CMS Ex. 21.

It is clear from these facts that the residents in question experienced significant changes in their conditions relating to pressure sores, but the Facility failed to make timely notifications to the resident's family and physicians as required by section 483.10(b)(11)(i)(B). CMS's prima facie case supporting the deficiency stands unrefuted--hence, it is upheld.

b. F Tag 166

CMS presented evidence, constituting a prima facie case, that the Facility failed to address Resident 10's complaint that the call light system in her room was broken. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.10(f)(2) requires that a resident has the right to prompt efforts by the facility to resolve grievances the resident may have. The evidence shows that Resident 10, who was cognitively alert and with no memory problems indicated, complained that the call lights in her room and bathroom were broken. Resident 10 made this complaint on August 9, 1999, during the survey, and to Facility staff prior to the survey. Yet the Facility had no records showing that it addressed the resident's complaints. Stipulated Facts 11-12; CMS Ex. 15, at 4; CMS Ex. 3, at 3.

It is clear from these facts that Resident 10 had a grievance, and Resident 10 expressed the grievance to the Facility on more than one occasion. But, the Facility failed to make prompts efforts (in fact it appears the Facility made no efforts) to resolve the grievance as required under section 483.10(f)(2). CMS's prima facie case supporting the deficiency stands unrefuted, and it is therefore upheld.

c. F Tag 241

CMS presented evidence, constituting a prima facie case, that the Facility failed to respect the dignity of one resident while providing him care. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.15(a) requires that the facility promote care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect in full recognition of his or her individuality.

The evidence shows that one resident was administered medication while seated on the toilet, and that the bathroom stank of feces. CMS Ex. 3, at 4. This presents a prima facie case that the Facility failed to promote care so as to maintain or enhance the resident's dignity as required by section 483.15(a). Absent some compelling medical or safety rationale, it is inappropriate and offensive to disturb a resident who is on the toilet. And in the absence of an explanation why the resident was administered medications while seated on the toilet, the facts are suggestive that it was done merely for the convenience of the Facility's staff. CMS's prima facie case supporting the deficiency stands unrefuted, so it is upheld.

d. F Tag 274

CMS presented evidence, constituting a prima facie case, that the Facility failed to conduct a comprehensive assessment of Resident 5 within 14 days of a significant change in condition. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.20(b)(2)(ii) requires that a facility conduct a comprehensive assessment of a resident within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. For purposes of this section, a "significant change" means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan, or both.

The evidence presented shows that Resident 5 was assessed, on the Minimum Data Set done November 11, 1998, to be continent of bowel and bladder and without pressure sores. But, a quarterly review assessment done May 11, 1999, indicated that Resident 5 was frequently incontinent of bladder, occasionally incontinent of bowel, and had a stage II pressure sore. CMS Ex. 10, at 15, 17-18, 20, 22-23; CMS Ex. 24, at 8.

This presents a prima facie case that the Facility failed to conduct a significant change assessment as required by section 483.20(b)(2)(ii). The regulation provides that a significant change is one that requires intervention and further planning and review to resolve. The emergence and worsening of this Resident's incontinence, and the Resident's development of a pressure sore satisfy that definition. The assessment that led to the discovery of the changes was a quarterly assessment. A quarterly assessment, however, is not the same as a significant change assessment; it is routine and does not trigger further action by the facility. Thus, in the absence of evidence showing that a significant change assessment was done, the quarterly assessment stands as the only review of Resident 5's status for the relevant period. And, the quarterly assessment does not satisfy section 483.20(b)(2)(ii), which explicitly calls for a significant change assessment. As with the previous F Tags cited below the immediate jeopardy level, Petitioner does not refute CMS's prima facie case. Therefore, the deficiency is upheld.

e. F Tag 275

CMS presented evidence, constituting a prima facie case, that the Facility failed to conduct a comprehensive assessment of Resident 19. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.20(b)(2)(iii) requires that the facility conduct a comprehensive assessment of a resident not less often than once every 12 months. The evidence shows that as of August 13, 1999, the Facility's most current assessment for Resident 19 was dated November 27, 1997. There was no assessment conducted on Resident 19 in 1998. Stipulated Fact 14; CMS Ex. 24, at 9.

These facts constitue a prima facie case that the Facility failed to conduct a comprehensive assessment of Resident 19 at least once every 12 months as required by section 483.20(b)(2)(iii). Because Petitioner failed to refute the prima facie case, the deficiency is upheld.

f. F Tag 282

CMS presented evidence, constituting a prima facie case, that the Facility failed to ensure that services to Resident 5 were provided in accordance with the resident's plan of care. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.20(k)(3)(ii) requires that the services provided or arranged by the facility must be provided by qualified persons in accordance with each resident's written plan of care. The evidence shows that Resident 5's physician ordered the Facility to conduct Creatinine tests and monthly Lactic Acid tests on Resident 5. But, the Facility only conducted the Lactic Acid tests. CMS Ex. 10, at 32, 34.

These facts constitute a prima facie case that the Facility failed to provide services to Resident 5 in accordance with his written plan of care, as required by section 483.20(k)(3)(ii), because it failed to provide the tests in accordance with the physician's orders. This F Tag also stands unrefuted by Petitioner, and it is therefore upheld.

g. F Tag 314

CMS presented evidence, constituting a prima facie case, that the Facility failed to ensure that residents 1, 2, 4, 8, 10, 13 and 19 received necessary treatment and prevention for pressure sores. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.25(c) requires the facility to ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The evidence shows that Resident 1 was assessed as incontinent and at risk for pressure sores. Accordingly, Resident 1 was assessed as needing a pressure relieving devices while in a chair or bed. But, at the survey, Resident 1 was observed seated on an inadequate pressure relieving device. He was seated on one-inch egg shell cushion which did not provide pressure relief. Stipulated Facts 25-26; CMS Ex. 6, at 4.

Resident 2 was also assessed as incontinent and at risk for pressure sores, and this resident was also dependent for transfers. However, on August 11, 1999, Resident 2 was allowed to sit in the same position for more than three hours. And, for at least part of that time, Resident 2 was sitting in urine and feces. Compounding these facts, when Resident 2 was provided incontinence care, staff did not dry the resident or clean the front portion of the resident's body. Stipulated Fact 28; CMS Ex. 7, at 4-5.

Resident 4 was likewise assessed as incontinent and dependent, and Resident 4 was also at risk for pressure sores. However, when Resident 4 received incontinent care on two occasions on August 11, 1999, the Facility staff failed to use soap or periwash. This despite the fact the Facility's own instructions concerning perineal care for incontinence require the use of peri-wash. Stipulated Fact 27; CMS Ex. 9, at 3-4, 23.

Resident 8 was dependent and at risk for pressure sores. Accordingly, the Facility was required to provide pressure relieving devices to Resident 8 in bed and while sitting in a chair. Resident 8 had an excoriation identified in a plan of care dated July 21, 1999. But, on August 11, 1999, Resident 8 remained sitting in the same position in her wheelchair for over two hours, without a pressure relieving device. Stipulated Facts 29-32; CMS Ex. 13, at 4-5.

Resident 10 was assessed as incontinent and dependent on staff. Resident 10 had stage II pressure sores on August 2, 1999, but, by August 14, they were improving. Despite the Facility's policy that decubitus ulcers be kept as clean as possible, there were no dressings on the pressure sores and feces and urine were around them on August 16, 1999. The LPN providing care at the time explained that the dressings had been removed to give the pressure sores air. But, there was no physician's order to remove the dressings or give the pressure sores air. Stipulated Facts 33, 36-37; CMS Ex. 15, at 9, 57 and 82.

Resident 13 was dependent on staff and, on August 7, 1999, had a stage II pressure sore. No treatment was obtained for the sore and the resident's physician was not notified until August 12, 1999. By August 12, 1999 Resident 13 had developed an additional stage II pressure sore. Stipulated Facts 5, 18-20; CMS Ex. 18, at 7.

Resident 19 was a dependent resident whose Weekly Skin Audit Report for August 8 and August 9, 1999 showed that excoriation to his scrotum was improving. But, by August 12, 1999, records indicate Resident 19's excoriation had developed into a 1.2 cm. x .8 cm. pressure sore. Stipulated Facts 22-24.

These facts establish a prima facie case that the Facility failed to ensure that the residents who did not have pressure sores did not develop them, and that those residents that did have pressure sores received necessary treatment and services to promote healing, prevent infection and prevent new sores from developing, as required by section 483.25(c). The evidence establishes that all of these residents were at risk for developing pressure sores. Yet Residents 1, 2 and 8 were not provided adequate pressure relief devices and were left in the same seated position for long periods of time; Residents 2,4 were not provided thorough incontinence care; Resident 10's pressure sores were exposed to possible contaminants or infection; and Residents 13 and 19 were allowed to develop new pressure sores. These facts show that the Facility was not doing everything possible to provide care to these residents to heal and prevent pressure sores. Absent a showing that the Facility was taking all possible measures to prevent and treat sores, the deficiency is established. Petitioner has not refuted CMS's prima facie case, hence the deficiency is upheld.

h. F Tag 323

CMS presented evidence, constituting a prima facie case, that the Facility failed to ensure that the resident environment was as free of accident hazards as possible, because the Facility allowed hazardous substances to be left accessible and unattended. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.25(h)(1) requires the facility to ensure that the resident environment remains as free of accident hazards as possible. The evidence establishes that on August 13, 1999, the medication room door was open and the room was unattended. The room is at the C Hall nurse station, in the Alzheimer's unit. Inside the medication room were three containers labeled "pH Quat." The substance, "pH Quat,"is a cleaning agent. The bottles were marked "Harmful if Swallowed, Keep Out of Reach of Children." A bottle labeled "Spray and Wipe" bore the same warning label, and it was in the unlocked utility room on C Hall. There are cognitively impaired residents living on C Hall--some are prone to wandering.

These facts substantiate a prima facie case that the Facility failed to ensure C Hall was as free of accident hazards as possible, as required by section 483.25(h)(1). The danger to cognitively impaired residents posed by hazardous substances left unattended is obvious--and the warning labels on the bottles captures that danger perfectly. Petitioner has not refuted CMS's prima facie case, therefore, the deficiency is upheld.

i. F Tag 324

CMS presented evidence, constituting a prima facie case, that the Facility failed to ensure that Resident 5 was given adequate supervision and assistance devices to prevent accidents. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.25(h)(2) requires the facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. The evidence shows that Resident 5 needed two or more persons to assist with transfers between surfaces. On July 24, 1999, one nurse's assistant attempted to transfer Resident 5 using a Hoyer lift, but both the nurse's assistant and Resident 5 fell to the floor. The Facility's procedure for Hoyer lift transfers calls for the assistance of two staff members. As a result of the fall, Resident 5 sustained a hematoma and a skin tear. CMS Ex. 10, at 21; Stipulated Facts 41-43; Paula Smith Affidavit at 1-2.

These facts establish a prima facie case that the Facility failed to provide the supervision and assistance devices called for by section 483.25(h)(2). Both Resident 5's assessment and the Facility's procedure for transferring a resident with the Hoyer lift call for transferring Resident 5 with at least two staff members. Thus, the Facility has documented itself what constitutes adequate supervision and assistance devices for this Resident, yet it failed to adhere to its own assessment. Because Petitioner has not refuted this prima facie case, the deficiency is upheld.

j. F Tag 326

CMS presented evidence, constituting a prima facie case, that the Facility failed to ensure that Residents 10 and 11 were provided with their respective therapeutic diets. CMS's case regarding Resident 6 falls short of a prima facie case. Petitioner failed to offer evidence or argument to refute CMS's prima facie case concerning residents 10 and 11.

42 C.F.R. � 483.25(i)(2) requires that, based on a resident's comprehensive assessment, the facility must ensure that a resident receives a therapeutic diet when there is a nutritional problem. The evidence shows that a physician's order dated August 1, 1999, instructs the Facility to provide Resident 6 food and snacks at liberty. But, the Facility's snack chart for the 8:00 P.M. bedtime snack service on August 10, 1999, did not list Resident 6 for snack service. Stipulated Facts 55-56. Resident 10 had diabetes, was dependent on staff, was experiencing weight loss and had pressure sores. Resident 10's plan of care called for her to receive snacks, and a physician's order dated August 7, 1999, required that Resident 10 receive three snacks a day. On August 10, 1999 Resident 10 received her afternoon snack one hour and 45 minutes late, and she drank less than half the milk served with the snack. Resident 10 was a diabetic, and it is important that her blood sugar level be controlled so as to avoid diabetic coma. One way Resident 10 could control her blood sugar level was to eat certain foods on a schedule. Stipulated Facts 50-54; CMS Ex. 15, at 46-50; Mary Ann Smith Affidavit, at 2. Similar to Resident 10, Resident 11 was diabetic. The physician's order, dated August 1, 1999, required that Resident 11 receive specified snacks at bedtime every day. Resident 11's plan of care, dated May 18, 1999, also shows that Resident 11 is supposed to be served snacks. Yet on August 10, 1999 Resident 11 was not on the dietary manager's snack list. Stipulated Facts 44-45, 47; CMS Ex. 3, at 15; Mary Ann Smith Affidavit at 2.

The evidence does not present a prima facie case that the Facility failed to ensure Resident 6 received a therapeutic diet, as required by section 483.25(i)(2), but it does establish a prima facie case that the Facility failed to ensure a therapeutic diet for Residents 10 and 11. The facts regarding Resident 6 merely establish that Resident 6 should receive snacks at liberty, and that Resident 6 was not on the service list for the bedtime service on a single day. These facts by themselves do not support a finding that the Facility failed to provide Resident 6 food and snacks at liberty as required by the physician's order. The omission of Resident 6 from the snack service list for one snack service time on one day is subject to several equally reasonable interpretations. So, while one interpretation of the omission is that the Facility was deficient, it is an equally plausible interpretation that the Facility was not required by the physician's order to provide Resident 6 a snack at every serving, unless Resident 6 wanted one. The facts as presented do not support a finding that Resident 6 was not offered a snack as requested, or that the physician's order was not followed. Thus, I find the facts regarding Resident 6 ambiguous and I decide that CMS failed to present a prima facie case concerning this resident.

Nonetheless, the F Tag is upheld because the facts do support a prima facie case that the Facility failed to provide Residents 10 and 11 their snacks as part of a therapeutic diet for those two Residents. The physician's orders for the two residents was detailed and explicit, so that the omission, or significant departure from, the snack service schedule for these Residents is prima facie deficient. Snack service one hour and 45 minutes later than scheduled for a diabetic resident, and the omission from snack service for a resident who is supposed to receive a specific snack every evening, is sufficient factual support that the Facility was not complying with section 483.25(i)(2). Petitioner offered no argument or evidence in rebuttal.

k. F Tag 371

CMS presented evidence, constituting a prima facie case, that the Facility failed to distribute and serve food to residents under sanitary conditions when a staff member handled food being served, food service trays, and diet cards to be placed on the trays, all while wearing the same pair of gloves. CMS Ex. 3, at 18; Mary Ann Smith Affidavit. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.35(h)(2) requires that the facility must store, prepare, distribute, and serve food under sanitary conditions. The evidence supports a prima facie case that there were lapses in food handling procedures which could have led to contamination of the residents' food. CMS's prima facie case stands unrefuted and the deficiency is upheld.

l. F Tag 498

CMS presented evidence, constituting a prima facie case, that the Facility failed to demonstrate competency in skills and techniques necessary to care for Residents 1 and 3 according to their assessed and care-planned needs. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.75(f) requires the facility ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care. The evidence shows that while feeding Resident 1 on August 12, 1999, a nurse aide spilled oatmeal over Resident 1's face and gown several times over the course of two minutes. Stipulated Fact 65; Suzanne Ray Affidavit at 2-3. And, on August 10, 1999, a nurse aide providing incontinence care to Resident 3, wiped urine and feces front to back, over an undressed stage II pressure sore; used a towel smeared with feces on the Resident; and failed to clean Resident 3's front side. Stipulated Fact 66; Suzanne Ray Affidavit at 3.

These facts establish the Facility's failure to ensure competency in the necessary skills and techniques for the care of Residents 1and 3, as required by section 483.75(f). The facts show that the staff was neither able to competently feed Resident 1, nor properly provide incontinence care to Resident 3. As these facts are unrefuted, the deficiency is upheld.

m. F Tag 502

CMS presented evidence, constituting a prima facie case, that the Facility failed to provide residents 5 and 7 with laboratory services appropriate to their needs. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.75(j)(l) requires that the facility must provide or obtain laboratory services to meet the needs of its residents. And, the facility is responsible for the quality and timeliness of the services. The evidence shows that Resident 5's physician ordered the Facility to conduct Creatinine tests and monthly Lactic Acid tests for Resident 5. But, the Facility only conducted the Lactic Acid tests. CMS Ex. 10, at 32, 34. Resident 7's physician order a Prothrombin Time test be done every month. A Prothrombin Time test was done as required on July 7, 1999, but, by August 17, 1999, there was no documentation that the Prothrombin Time test had been done for August 7, 1999. Stipulated Facts 67, 70-71.

This evidence is sufficient to sustain a prima facie case that the Facility failed to provide the laboratory services as ordered by Resident 5's and Resident 7's physicians, as required under section 483.75(j)(l). Petitioner did not offer evidence or argument to refute CMS's prima facie case, so the deficiency is upheld.

n. F Tag 505

CMS presented evidence, constituting a prima facie case, that the Facility failed to promptly notify Resident 17's physician of the results of a test the physician ordered. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.75(j)(2)(ii) requires that the facility provide or obtain laboratory services only when ordered by the attending physician and promptly notify the attending physician of the findings. The evidence shows that there was a physician's order that Resident 17 be administered a fasting blood sugar test every month. The fasting blood sugar test performed July 15, 1999, yielded a low reading of 55. Normal results are between 70-110. This result was received, timed, and noted by the Facility on July 16, 1999. As of August 13, 1999, however, the Facility had no documentation that the physician was notified of the results. On July 22, 1999 Resident 17's condition required the administration of Glucagon which is used to treat severe hypoglycemic reactions in diabetic patients who are unconscious or unable to swallow. Stipulated Facts 74-80; CMS Ex. 19, at 19.

These facts support a prima facie case that the Facility failed to promptly notify Resident 17's physician of the finding of the low reading from the blood sugar test as required by section 483.75(j)(2)(ii). The unrefuted facts indicate that the low test result was not communicated to Resident 17's physician and the Resident experienced a change in his condition related to diabetes shortly after the test. In the absence of evidence or argument from Petitioner the deficiency is upheld.

o. F Tag 514

CMS presented evidence, constituting a prima facie case, that the Facility failed to adequately maintain clinical records for Residents 4 and 10. Petitioner failed to offer evidence or argument to refute CMS's prima facie case.

42 C.F.R. � 483.75(l)(1) requires that the facility maintain clinical records on each resident in accordance with accepted professional standards and practices. The records must be complete, accurately documented, readily accessible and systematically organized.

The evidence shows that the Facility records for Resident 4 included two physician's orders for a geri chair without a tray table, and a consent form, signed by the Resident's spouse, for a geri chair with a tray table. The physician's orders were dated May 29, 1999 and August 1, 1999. The consent form was dated August 1, 1999. Stipulated Facts 83-84. Resident 10 had a physician's order dated August 7, 1999 for pulse oximetry to be taken three times daily and oxygen to be administered, but, upon review on August 9, 1999, there was no documentation for the pulse oximetry in the Medical Administration Record. Stipulated Fact 82.

These facts establish a prima facie case that the Facility failed to adequately maintain clinical records for Residents 4 and 10 in accordance with section 483.75(l)(1). The conflicting orders for Resident 4's geri chair reflect that the resident's records are inaccurate or disorganized. And, the omission of the pulse oximetry information from Resident 10's files demonstrates that the records are incomplete. Absent evidence or argument from Petitioner the deficiency is upheld.

3. The reasonableness of the CMPs.

I find that the amount of the CMPs is consistent with the deficiencies that existed at the Facility and that the CMPs are reasonable. The CMP for the period of immediate jeopardy, $5,050 per day, is at the midrange of possible penalties. This is appropriate considering that there was a pattern of deficient care, effecting several residents, over the course of 13 days. The CMP of $150 per day is also consistent with the 15 deficiencies I upheld below the immediate jeopardy level of scope and severity. $150 per day is at the low end of possible penalties. Considering that the these deficiencies were numerous, albeit isolated, and some entailed actual harm to residents, $150 per day is reasonable.

Petitioner argues that the "[a]ssessment and imposition of the civil money penalty is an error." Petitioner's Brief at 29. Petitioner advances two arguments to support its assertion that the amount of the CMPs is unreasonable. First, Petitioner argues that the evidence does not support a finding of immediate jeopardy, so the lower range of possible penalties should apply to the three deficiencies cited at the immediate jeopardy level of scope and severity. Id. Second, Petitioner alleges that CMS did not take into account the Facility's history of noncompliance and its financial condition, as required under 42 C.F.R. � 488.438. Petitioner's Brief at 30. Petitioner is mistaken on the first argument, because, as I have discussed in detail in section IV. C. 1 (above), the evidence supports a finding that CMS's decision to impose immediate jeopardy is not clearly erroneous. See 42 C.F.R. � 498.60(c)(2). My finding that the assignment of the immediate jeopardy level of noncompliance is not clearly erroneous ends any need to consider Petitioner's first argument further, because Petitioner challenged the range of the penalty, but offered no argument or evidence to challenge the amount. And, as I indicated above, the amounts are consistent with the nature of the deficiencies and are, therefore, reasonable. Concerning the second argument, Petitioner is mistaken on the law governing my review of the reasonableness of the amount of the CMP.

Petitioner argues that CMS failed to consider the Facility's history of noncompliance, the Facility's financial condition, the severity of the deficiencies, the relationship of the deficiencies to other deficiencies resulting in noncompliance, and the culpability of the provider, as required under 42 C.F.R. �� 488.438(f) and 488.404. But, it is not my role to determine whether CMS followed the correct procedure in setting the amount of the CMP. My role is limited to reviewing, de novo, the evidence in the record concerning the factors in section 488.438(f), not the information CMS reviewed in setting the amount. See Emerald Oaks, DAB No. 1800 (2001); CarePlex of Silver Spring, DAB No. 1683 (1999). I have explained my finding that the evidence supports that the amount of the CMPs is reasonable in relation to the deficiencies found, and Petitioner has offered no evidence concerning any of the other factors; therefore, Petitioner's argument is unavailing and the amount of the CMPs is upheld.

V. Conclusion

Based on the forgoing, there was a basis for the imposition of the CMPs; and the amounts of the CMPs are reasonable as imposed.

Richard J. Smith

Administrative Law Judge

1. The surveyors and CMS refer to individual deficiencies as "F Tags," and designate each deficiency with an F Tag number on the statement of deficiencies. Thus, the individual regulations setting forth the requirements for participation are commonly referred to by their "Tag" number, and not by the regulatory citation.

2. In its brief, Petitioner indicates residents were checked on a hourly basis (Petitioner's Brief at 10); however, I have found that the evidence supports that the Facility was checking on residents every two hours. Finding of Fact 4d; CMS Ex. 25, at 18.

3. Petitioner states that a communication system may be "electronic, verbally calling, noisemaker, visual observation with noise alert or other mechanism as designed by the Facility." Petitioner's Brief at 3. I make no finding that 42 C.F.R. � 483 (f) requires an electronic call light system, but I take administrative notice that hospitals and nursing homes use button operated call systems. And, the overarching regulatory scheme is to protect residents in nursing facilities; so the call light system should be configured so it is practical and useful for that purpose.

4. The evidence shows the call light system failed on July 29, 1999, and continued to fail thereafter, until the end of the immediate jeopardy period on August 10, 1999. CMS maintains that Facility staff indicated that the call light system was "completely out" beginning on July 29, 1999. But, Petitioner argues that no staff member indicated that the system failure was "completely out." I agree with CMS that P. Ex. 121, the statement of Facility staff denying that they told surveyors the system was "completely out," is self serving, having been created and added to the record in the briefing stage of the case. Nonetheless, it is not necessary that I find which statement was made, because both statements, taken with the other evidence of the Facility's actions and omissions, support the deficiency.