CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

SunBridge Care and Rehabilitation for Griffin,

Petitioner,

DATE: November 04, 2003
                                          
             - v -

 

Centers for Medicare & Medicaid

 

Docket No.C-01-296
Decision No. CR1102
DECISION
...TO TOP

DECISION

SunBridge Care and Rehabilitation for Griffin (Petitioner or facility) is a nursing facility, located in Griffin, Georgia, that is certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare and Medicaid Services' (CMS) determinations that, from November 16 through December 26, 2000, it was not in substantial compliance with Medicare requirements, and that from November 16 through 26, 2000, its conditions posed immediate jeopardy to resident health and safety.

For the reasons set forth below, I conclude that the facility was not in substantial compliance with program requirements during the period in question, and that for 11 days, from November 16 through 26, 2000, the facility's deficiencies posed immediate jeopardy to resident health and safety. I also find that the amount of the civil money penalty (CMP) imposed - $5,000 per day for 11 days and $750 per day for 30 days (total of $77,500) - is reasonable. (1)

BACKGROUND

After receiving complaints that the facility was neglecting its residents, the Georgia Department of Health and Human Resources (State Agency) conducted a complaint investigation and partial extended survey on November 9, 13, and 16, 2000. CMS Exs. 8, 11, 17; Tr. 36. Following the survey, the State Agency concluded that the facility was not in substantial compliance with program requirements, specifically:

•Tag F157 - Resident Rights (Notification of rights and services), 42 C.F.R. § 483.10(b)(11);

•Tag F224 - Resident Behavior and Facility Practices (Staff treatment of residents), 42 C.F.R. § 483.13(c)(1)(i);

•Tag F312 - Quality of Care (Activities of daily living), 42 C.F.R. § 483.25(a);

•Tag F314 - Quality of Care (Pressure sores), 42 C.F.R. § 483.25(c);

•Tag F353 - Nursing Services (Sufficient staff), 42 C.F.R. § 483.30(a); and

•Tag F521 - Administration (Quality assessment and assurance), 42 C.F.R. § 483.75(o).

CMS Ex. 17; P Ex. 1.

CMS reviewed the state findings and, by letter dated November 21, 2000, advised the facility that its conditions constituted immediate jeopardy to resident health and safety, and that the following remedies would be imposed:

•a directed plan of correction;

•state monitoring, effective December 6, 2000;

•denial of payment for new admissions, effective December 6, 2000;

•termination of the facility's provider agreement, effective December 9, 2000; and

•imposition of a $5,000 per day CMP, effective November 16, 2000, and continuing until the facility achieved substantial compliance or its provider agreement was terminated.

P. Ex. 2. The letter also advised the facility that its noncompliance with sections 483.13, 483.15, and 483.25 constituted "substandard quality of care" as defined in 42 C.F.R. § 488.301, and that the facility's nurse aide training and competency evaluation programs would not be approved. Id. Finally, the letter advised Petitioner of its right to request a hearing no later than 60 days after the date it received the notice, and specifically directed Petitioner's attention to 42 C.F.R. § 498.40, the regulation that dictates the requirements for filing a valid hearing request.

The facility submitted a plan of correction, dated December 1, 2000, asserting that it had corrected the cited deficiencies as of November 27, 2000. CMS Ex. 17. CMS accepted what it characterized as "credible allegations of removal of jeopardy," and, by letter dated November 28, 2000, advised the facility of the revised remedies:

    •a CMP of $5,000 per day from November 16 through 26, 2000, and $750 per day, effective November 27, 2000, continuing until the facility achieved substantial compliance;

    •denial of payment for new admissions, effective December 6, 2000; and

    •termination of the facility's provider agreement, effective May 16, 2001.

P. Ex. 3.

Following a revisit survey on December 27, 2000, CMS determined that the facility achieved substantial compliance as of that day. By letter dated January 3, 2001, CMS advised the facility that it had cancelled the DPNA and the termination action. P. Ex. 4.

In a letter dated January 4, 2001, Petitioner requested a hearing. Thereafter, CMS moved to dismiss Petitioner's hearing request because it failed to meet the content requirements of 42 C.F.R. § 498.40(b), which requires that the request must 1) identify the specific issue, and the findings of fact and conclusions of law with which the affected party disagrees, and 2) specify the basis for contending that the findings and conclusions are incorrect. While I agreed with CMS that Petitioner's hearing request did not satisfy the regulatory requirements for a valid hearing request, I also recognized the Departmental Appeals Board (Board) directive that ALJ's "choose remedies short of outright dismissal to effectuate regulatory purposes" of requiring specificity in hearing requests. The Carlton at the Lake, DAB No. 1829 (2002); Alden Nursing Center - Morrow, DAB No. 1825 (2002). Therefore, in a ruling and order dated November 15, 2002, I denied CMS's Motion to Dismiss, and set forth procedures for the parties' pre-hearing exchanges. In order to achieve the regulatory purpose of requiring Petitioner to specify what it was appealing, I required Petitioner to submit its pre-hearing exchange first. Ruling and Exchange Order (Nov. 15, 2002). Inasmuch as CMS had filed with its motion a detailed Statement of Deficiencies and Plan of Correction setting forth with considerable specificity the cited deficiencies, this did not appear an onerous burden. See HCFA's Memorandum in Support of Motion to Dismiss for Failure to File a Request for Hearing, Exhibit 2. Petitioner did not object, and the parties submitted their exchanges in accordance with my order, as amended by a December 17, 2002 amended order granting the parties additional time.

A hearing was held before me on May 5 and 6, 2003, in Atlanta, Georgia. Mr. Joseph L. Bianculli appeared on behalf of Petitioner, and Ms. Elizabeth Benton appeared on behalf of CMS. Prior to and during the hearing, I admitted CMS Exhibits (CMS Exs.) 1 through 17, except for pages 12 and 13 of Exhibit 1, which I declined to admit (see April 24, 2003 Order) and Petitioner's Exhibits (P. Exs.) 1 through 137. During the hearing I also admitted ALJ Exhibit (ALJ Ex.) 1.

With its post-hearing memoranda, Petitioner submitted additional declarations from two witnesses: Jillene Snow, R.N., and Deborah Alexander (nee Smith), L.P.N. (hereafter LPN Smith). Even later, Petitioner submitted an additional declaration from Dr. Robert Hall. CMS has objected to the admission of these declarations. For reasons discussed below, I admit the declaration of LPN Smith, but decline to admit the additional declarations from Dr. Hall and RN Snow.

ISSUE

The issues before me are:

1. Whether, from November 16, 2000, through December 26, 2000, the facility was in substantial compliance with program participation requirements, specifically, 42 C.F.R. § 483.10 (resident rights), 42 C.F.R. § 483.13 (resident behavior and facility practices), 42 C.F.R. § 483.25 (quality of care), 42 C.F.R. § 483.30 (nursing services), and 42 C.F.R. § 483.75 (administration).

2. If the facility was not in substantial compliance, did its conditions for the period from November 16 through 26, 2000, pose immediate jeopardy to resident health and safety; and

3. If the facility was not in substantial compliance, was the amount of the CMP imposed, $5,000 per day for 11 days, and $750 per day for 30 days, reasonable?

STATUTORY AND REGULATORY BACKGROUND

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, §§ 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301.

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

The facility is required to make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. § 483.20(b)(2)(ii). Based on the comprehensive assessment, the facility must ensure that a resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene. 42 C.F.R. § 483.25(a)(3). Based on the comprehensive assessment, the facility must ensure that a resident who enters the facility without pressure sores does not develop them unless the individual's clinical condition shows that they were unavoidable, and a resident having pressure sores receives treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. § 483.25(c).

The facility must have sufficient nursing staff, including sufficient numbers of licensed nurses and other nursing personnel, to provide nursing and related services so that residents attain or maintain their highest practicable physical, mental, and psychosocial well-being, as determined by their assessments and plans of care. 42 C.F.R. § 483.30(a).

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

A resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident. This includes notification of changes. 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 of:

    •a significant change in the resident's physical, mental, or psycho-social status (i.e. a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications);

    •a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment); or

    •a decision to transfer or discharge the resident from the facility.

42 C.F.R. § 483.10(b)(11).

The facility must also be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. 42 C.F.R. § 483.75. Among other requirements, it must maintain a quality assessment and assurance committee consisting of the director of nursing services, a physician, and at least three other staff members. The committee meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary, and develops and implements appropriate plans of action to correct identified quality deficiencies. 42 C.F.R. § 483.75(o).

Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. Immediate jeopardy can exist regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998). CMS's determination as to the level of a facility's noncompliance - which includes its immediate jeopardy finding - must be upheld unless it is "clearly erroneous." 42 C.F.R. § 498.60(c).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a CMP. See Act, § 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. §§ 488.430(a), 488.440. In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for causing more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. 42 C.F.R. § 488.483(a)(1)(ii). Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. § 488.438.

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

DISCUSSION

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

In the interest of judicial economy, I decline to rule on every deficiency cited. However, I discuss deficiencies that were persuasively established, and are sufficient to support the remedies imposed. Beechwood Sanitarium, DAB No. 1824, at 19 (2002). Of course, no inferences should be drawn as to the merits of any issue on which I have declined to comment.

I. From November 16, 2000, through December 26, 2000, the facility was not in substantial compliance with program participation requirements.

A. Because of its practices in treating residents at risk of developing pressure sores, and in treating those who developed pressure sores, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25 (Quality of Care) and § 483.10 (Resident Rights), from November 16, 2000, through December 26, 2000.

Among the deficiencies cited, the facility's approach to the prevention and treatment of pressure sores and similar wounds was most problematic. (2) The facility employed as its wound care "specialist," a licensed practical nurse (LPN), Deborah Smith. Tr. 266; Smith Decl. at 1, ¶ 1.

Barbara Chuven is a registered nurse, currently employed by the State Agency as training coordinator for surveyors. At the time of the survey, she was a surveyor of long term care facilities and was part of the team that surveyed the facility in November 2000. CMS Ex. 13, at 1, 4 (Chuven Decl.). Surveyor Chuven characterized LPN Smith's level of training in wound care as "minimum training" (Tr. 179), and, according to surveyor notes taken at the time of the survey, LPN Smith's personnel file contained no documentation as to that training. CMS Ex. 4, at 7. The notes also indicate that LPN Smith obtained her LPN license in March 1999, having worked as a CNA prior to that. Id.

Petitioner offers no evidence establishing LPN Smith's qualifications as a wound care specialist. It offers only some non-specific testimony from Duett Parrish, a registered nurse who is board certified in wound care. Parrish Decl. at 1. At the time of the survey and currently, RN Parrish is a sales representative for the company that sells wound care products to Petitioner. Tr. 250. His testimony does not specify how much time he spent at the facility, nor the times and circumstances under which he observed LPN Smith's performance. According to RN Parrish, "at the time that all of this was going on she was very nerve wracked and she wasn't functioning at this time at her best," but he "had seen her at other times and . . . would call her a competent treatment nurse." Tr. 266.

Given the absence of any real foundation for RN Parrish's opinion, and inasmuch as his testimony included no specific information, I do not find it particularly useful in assessing LPN Smith's qualifications. I also find it troubling that Petitioner withheld the details of LPN Smith's training and experience, which certainly should have been in its possession. Finally, I note that RN Parrish agreed with CMS that a licensed practical nurse is "probably not" qualified to assess conditions, such as kidney function, that are related to wound care. I think that RN Parrish is probably correct on that point, which raises additional questions as to the LPN's ability to perform the role the facility had assigned her. Tr. 267-268. As I discuss in detail below, the evidence establishes that LPN Smith diagnosed and treated wounds without physician involvement. Review of the facility's treatment records establishes that she was not able to perform this important function competently, and that the facility's practice did not comport with the regulations, standards of care, nor with the facility's own written policies.

1. The facility did not do everything in its power to promote healing, prevent infection, and prevent pressure sores from developing.

a. The facility did not timely treat Resident #1's skin breakdowns.

Resident #1 was an 87-year-old woman who suffered from dementia. P. Ex. 8. On October 16, 2000, she fell and fractured her hip, thereafter seriously limiting her mobility. P. Ex. 7, at 1; P. Ex. 12, at 1-2; P. Ex. 14, at 2. Treatment notes indicate that following the injury, her right leg became edematous and she had contractures. P. Ex.12, at 3-6. She was also frequently incontinent. P. Ex. 8, at 4, 8. An assessment dated October 21, 2000, indicates that she had no pressure ulcers at that time, but was at risk of developing them due to her incontinence. P. Ex. 10, at 2.

Notwithstanding the October 21 assessment, the record contains no evidence that the facility took any specific measures, prior to October 31, 2000, to prevent Resident #1 from developing pressure sores. On October 31, the facility amended her care plan to add strategies for preventing pressure sores. The October 31 amendments instruct staff to check skin daily "for reddened areas/excoriation/breakdown," and to "report any excoriation, reddened or pressure areas to supervisor immediately." Staff is to "provide immediate perineal care following incontinent episodes," reposition her every two hours "to maintain proper body alignment," check her every two hours and as needed for episodes of incontinence, wash with soap and water, and apply a moisture barrier cream as needed. P. Ex. 11, at 5-6.

Elsewhere, the plan addresses specifically Resident #1's potential for impaired skin integrity related to her bladder and bowel incontinence, and instructs staff to protect her skin from bumps, scrapes, restrictive or tight fitting clothing, to keep the skin clean and dry, lubricate with a moisture barrier cream, report to a supervisor reddened areas, changes in skin temperature, or skin tears, encourage the resident to turn and reposition herself every two hours and as needed "to maintain proper positioning, body alignment, and skin free from breakdown," and to observe her skin daily during routine care, again reporting any reddened area to a supervisor. P. Ex. 11, at 16-17.

Surveyor Chuven testified that on November 2, 2000, Resident #1 had developed sores on her buttocks, yet the facility did not begin treatment of those sores for an entire week. CMS Ex. 2, at 11; CMS Ex. 13, at 2-3, ¶ 11 (Chuven Decl.); CMS Ex. 17, at 11; P. Ex. 1, at 2. (3) On November 9, the surveyor herself observed multiple open wounds (stage II pressure sores) on Resident #1's buttocks, but the facility had no treatment sheet, and had apparently taken no action to treat the sores. CMS Ex. 13, at 3, ¶ 11 (Chuven Decl.); CMS Ex. 2, at 1. The surveyor described the wounds in detail: a 2" x 3" area on the left buttock that was "red with puckered grayish white tissue and open areas;" a quarter size stage 2 pressure sore on the right buttock that was "light tan in the center surrounded by red with an approximately Ľ" black area on the upper edge." CMS Ex. 17, at 11. According to Surveyor Chuven, the responsible LPN acknowledged that the resident had stage II sores, and subsequently obtained and implemented a treatment order for Normigel, a product used to protect, hydrate, and fill in dead spaces in deep wounds, and Alldress, a dressing to cover and protect wounds. CMS Ex. 13, at 3, ¶ 11 (Chuven Decl.).

Surveyor Chuven's testimony in this regard is supported by the record evidence. A skin assessment dated November 2, 2000, signed by Shasta Walker, describes discolorations and "breakdown on buttocks." P. Ex. 14, at 3; CMS Ex. 2, at 7. Petitioner submitted this assessment as one of its own exhibits, and has not challenged its validity. Instead, in its initial brief, Petitioner simply misstates the date and contents of the assessment. Citing P. Ex. 14, at 3, Petitioner erroneously declares that "on November 9, 2000, a nursing assessment indicated a discoloration and beginning of a breakdown on the Resident's buttocks." (Emphasis added) P. Brief at 30. The assessment is obviously dated November 2, 2000, and not November 9, 2000. (4) I note also that, contrary to Petitioner's assertion, the document does not say "beginning." It says "breakdown on buttocks." In its reply brief, Petitioner concedes that the observation is dated November 2, but, remarkably - considering that this document was generated by its own staff - criticizes the assessment for its lack of specificity, and declares it "impossible on this record to determine what, if anything, the nurse thought she saw on November 2." P. Reply at 17. Of course, Petitioner could have included in the record an explanation of the entry, but did not call as a witness Shasta Walker nor any other staff member capable of providing that explanation.

Petitioner also declares "no evidentiary or clinical basis to infer that whatever was observed on November 2 had progressed to untreated stage 2 pressure ulcers one week later." P. Reply at 17. I disagree. On November 2, 2000, Resident #1 had a documented skin breakdown. Notwithstanding her care plan, which required staff to report "any excoriation, reddened, or pressure areas to supervisor immediately" (P. Ex. 11, at 5, 17), no evidence suggests that the breakdown was reported. No evidence suggests that the breakdown was treated. One week later, Resident #1 had stage II pressure ulcers in the same place. Nursing notes dated November 9, 2000, describe a stage II decubitus to the buttocks, and indicate that the treatment nurse was "made aware - new orders noted and treatment rendered per treatment nurse." P. Ex. 12, at 7: P. Ex. 19, at 2; CMS Ex. 2, at 6.

A November 9, 2000 entry in Resident #1's care plan notes "impaired skin integrity related to: pressure area," and sets forth a list of instructions to staff, including skin check every day, report reddened or open areas, changes in skin temperature or exudate to supervisor, protect pressure areas from contamination with urine or feces, report increased drainage or uncharacteristic odors, turn and reposition every two hours or as needed, use "pressure reducing device prime air mattress," "measure & establish parameters to determine response to treatment," provide whirlpool therapy as scheduled, encourage the resident to eat at least 75% of her meals and offer substitutes if she refuses a meal, "treatment per MD orders," and "administer medications as ordered per MD." P. Ex. 11, at 18.

A medication order dated November 9, signed by LPN Smith and by the physician, orders "clean (L) buttock [with] dermal wound cleanser, apply Normigel and Alldress [every day] and [as needed]," and "clean (R) buttock [with] dermal wound cleanser, apply Normigel and Alldress [every day] and [as needed]." P. Ex. 17, at 5. An order dated November 16, discontinues the treatment to the left buttock. P. Ex. 17, at 7.

A dietician note dated November 19 confirms the presence of a wound on the right buttock, and states that the resident was taking zinc sulfate and Vitamin C. CMS Ex. 2, at 16. A November 19 assessment note written by Susan Chastain, one of the two nurse/sales representatives brought in to examine residents following the survey, describes a sacral wound, type II. Because of the poor quality of the photocopy, I am not able to determine her assessment as to the size of the wound, nor the entry under drainage. P. Ex. 15. An order dated November 19, with the physician signature dated November 19, continues the "current [treatment] of Normigel and Alldress to sacrum." P. Ex. 17, at 8. Nurses notes indicate that the sacral area wound measured .2 x .1 cm on November 22, and the area was healed on November 25, 2000. P. Ex. 12, at 12.

The only reasonable inference to be drawn from this unrebutted documentary evidence is that Resident #1 had skin breakdowns that went untreated for a week, and progressed to stage II pressure ulcers, at which point staff reported the problem, obtained physician orders, and began treatment. (5)

To comply with federal requirements for the prevention and treatment of pressure sores, the facility "must always furnish what is necessary to prevent new sores, unless clinically unavoidable, and must treat existing ones, as needed." Crestview Parke Care Center, DAB No. 1836, at 20 (2002); Koester Pavilion, DAB No. 1750, at 32 (2000). Here, although she was at risk, nothing in the record suggests that Resident #1's pressure sores were unavoidable, and they obviously resolved with appropriate treatment. Moreover, even if a facility determines that pressure sores are unavoidable, it may not abandon its efforts to prevent and treat them. The relevant question is: did the facility "take all necessary precautions" to promote healing, prevent infection, and to prevent new sores from developing. If so, and the resident develops sores anyway, I could find no deficiency. But if the evidence establishes that the facility fell short of taking all necessary precautions, and the resident develops pressure sores, then the regulation is violated. Koester at 32. The facility was not doing much of anything to prevent and treat pressure sores until November 9. On November 2, when staff observed skin breakdown, it should then have responded with the type of treatment it only began to provide on November 9. See also P. Ex. 53, at 14-19.

Without referencing Resident #1 or any other particular resident, Petitioner argues generally that the surveyors misidentified as pressure sores wounds that were not pressure sores. In this regard, Petitioner incorrectly states that pressure sores form only on bony prominences, and do not form on the buttocks. P. Brief at 17 (citing Parrish testimony). While bony prominences are certainly vulnerable areas, Petitioner's own in-service training documents identify the buttocks as a site "where pressure sores commonly develop." P. Ex. 56, at 5. And Petitioner's own protocol for the treatment of pressure ulcers discusses the special care required when pressure ulcers develop on the buttocks so as to avoid resident exposure to urine and feces. P. Ex. 53, at 15. Moreover, with respect to Resident #1, the treatment record definitively establishes that her wounds were pressure sores. P. Ex. 12, at 7; P. Ex. 19, at 2; P. Ex. 11, at 18.

b. The facility did not take necessary precautions to prevent Resident #4 from developing pressure sores, and, when sores developed, did not provide treatment necessary to promote healing and prevent infection.

Resident #4 was admitted to the facility in February 2000. At the time of the survey, he was a 62-year-old man who had suffered a closed head trauma and cerebral vascular accident resulting in hemiparesis (partial paralysis affecting one side of the body). He required one person physical assist for bed mobility and transfers. He was totally dependent for locomotion, dressing, toilet use, and personal hygiene. P. Ex. 21, at 3-4; P. Ex. 24, at 1. He was bedfast all or most of the time and he was incontinent. P Ex. 21, at 4; P. Ex. 28, at 1. He had a history of pressure sores, and was at risk for developing pressure sores, but had none at the time of his admission to the facility. P. Ex. 20; P. Ex. 21, at 6; P. Ex. 23, at 3; P. Ex. 28, at 1-2. According to Resident #4's initial assessments, he required pressure relieving devices, a turning/repositioning program, and nutrition/hydration intervention. P. Ex. 21, at 6; P. Ex. 24, at 2. A care plan dated March 31, 2000, instructs staff to turn and reposition Resident #4 every two hours and as needed, report any reddened areas to the nurse, apply a moisture barrier, cleanse and dry after episodes of incontinence, and check for incontinence every two hours or as needed. P. Ex. 24, at 4.

Resident #4 was thus highly vulnerable, and required an aggressive, multidisciplinary approach to prevent and treat pressure sores. However, according to CMS, LPN Smith issued treatment orders without consulting, or even notifying, Resident #4's attending physician, and treatment was often provided without any valid physician order. CMS also cites examples of delayed, insufficient, or inappropriate treatment. At the same time, a valid physician order for heel pads was not followed.

The record supports CMS's position.

Left ankle and heel. In February 2000, Resident #4 had no pressure sores. According to treatment records, he developed a pressure sore on his left heel in June, but it resolved by July 19, 2000. P. Ex. 26, at 2; P. Ex. 27, at 1.

None of the facility nursing staff offered any testimony about Resident #4's care, and Petitioner provides minimal records for the period between July 21 and August 24, 2000. A physician order, dated July 21, 2000, discontinues the earlier order to clean the left heel with dermal wound cleanser and apply Alldress every day. P. Ex. 31, at 2. (6) In weekly pressure ulcer progress reports from June through July 12, LPN Smith checked off certain "preventive measures:" turning every two hours, prima pads, high protein supplements, and multivitamin/zinc. However, those treatments appear to have stopped as of July 19, and the record is silent as to what, if any, systematic preventive measures were being followed between July 19 and August 30. P. Ex. 27. Nevertheless, CMS does not argue any deficiencies with respect to facility efforts to prevent Resident #4 from developing pressure sores prior to August, and I do not find deficiencies in this regard.

In August, Resident #4 began to develop serious skin breakdowns. According to an August 20 skin assessment, Resident #4 was "red" in the groin and buttock areas, but had no skin breakdown. P. Ex. 28, at 4. On August 24, however, he had an open area on his left heel, measuring 3 x 4 cm., with sero-sanguineous drainage (drainage consisting of clear fluid and blood, CMS Ex. 13, at 5, ¶22 ). P. Ex. 26, at 3. On the weekly pressure ulcer report, LPN Smith resumed check-off of the preventive treatments provided prior to July 19 (turning every two hours, prima pads, high protein supplements, and multivitamin/zinc). P. Ex. 27, at 2.

On September 6, 2000, the physician ordered "clean L heel with dermal cleanser, apply Normigel and Alldress every day and as needed." P. Ex. 31, at 4. In notes and an order dated September 13, the physician describes a stage II decubitus on the left foot, orders a "foley [catheter] until the wound heals," and suggests that the resident would benefit from whirlpool. P. Ex. 30, at 4; P. Ex. 31, at 3. In his notes dated September 21, 2000, the physician also describes a "foul smell" to the wound. P. Ex. 30, at 4; see also P. Ex. 27, at 3; P. Ex. 32, at 1; P. Ex. 31, at 6 (October 17 "clarification" order calling for a Foley catheter to aid in wound healing and diagnosing L heel decubitus). (7)

In October, Resident #4's physician ordered bilateral heel protectors and a heel cushion to the left heel. P. Ex. 32, at 1, 3.

The October order sheet instructs: "Clean left heel with dermal cleanser, apply Normigel and Alldress every day and as needed." A handwritten entry indicates that this order was discontinued on October 18 and an order substituting Hypergel for Normigel is handwritten in. P. Ex. 32, at 3; P. Ex. 31, at 6.

On November 1, 2000, the left heel wound measured 5 x 5 cm., was red, with a foul odor. P. Ex. 26, at 6.

When the surveyors observed Resident #4 on November 9, all of the skin was gone from the bottom of his left heel, and the heel appeared "red, soft, mushy, surrounded by whitish tissue, and red area around that." Notwithstanding the physician's order for bilateral heel protectors while in bed, and a heel cushion to the left heel, the surveyors observed the resident in bed without heel protectors or cushion. Specifically, the survey team documented that at 3:50 p.m. on November 9, neither heel protectors nor cushions were in use. At 6:55 p.m. the same day, he still had no heel protectors. CMS Ex. 17, at 14-15; CMS Ex. 13, at 2, ¶ 9 (Chuven Decl.)

Petitioner has not exactly challenged the surveyor observations, claiming that it "cannot comment on surveyors' observations that its own staff did not witness." P. Brief at 74. Had the facility been compliant with the physician order for heel protectors, it presumably could have found staff able to testify that they were consistently applied as ordered. But Petitioner produced no one willing or able to make such claim. Instead, Petitioner effectively concedes that it was not applying the devices as ordered, but justifies its disregard of the physician order by arguing that the resident "was noncompliant with protective devices," and that other interventions, such as a pressure relieving mattress, would have been more effective, anyway.

Petitioner points to no evidence in this record suggesting that Resident #4's resistence to care precluded the application of heel protectors, and I was not able to find any. Indeed, although I do not doubt that he presented the staff with difficulties at times, the record shows that Resident #4's resistence to care was not as pivotal as Petitioner claims. Counseling notes show that he initially had difficulty adjusting to the nursing home, but improved. P. Ex. 25. A nurse progress note dated August 20 says that he is combative at times, but sits in a chair 3-4 hours daily, that he "sometimes" refuses meds but will take them with encouragement. P. Ex. 28, at 4. Nurses notes from August 24 on indicate that treatment was being provided. Each entry closes with "Tx. cont. as written," not suggesting that staff was not able to provide treatment. P. Ex. 26. See also P. Ex. 27, at 2 (weekly pressure ulcer progress reports). Notes dated September 18, 2000, describe Resident #4 as "periodically non-compliant" with medications and care, and he "may refuse psychotropic meds, but is compliant at this time." The note also describes him as "more stable since September 1, 2000." P. Ex. 25, at 1. On September 27, staff report a decrease in negativity since his medications started. He agreed with his doctor to cooperate with bathing. P. Ex. 25, at 2. On September 28, 2000, his care plan added "encourage resident to allow [treatment] nurse [to] treat open area on heel," but does not suggest that his resistence had anything to do with the heel protectors. P. Ex. 24, at 4. On October 2, 2000, he is "improving." P. Ex. 25, at 3. Subsequent counseling notes do not suggest ongoing problems with the resident refusing basic treatment. P. Ex. 25, at 4-8.

Petitioner cites a June 29, 2000 nursing note indicating that the heel protectors were applied on at least one occasion. ("Res. skin is easy to breakdown. Heel protectors applied.") P. Brief 73-74, citing P. Ex. 28, at 2. Obviously, one demonstrated instance of compliance five months earlier, does not establish that the facility was applying the heel protectors as ordered, whenever the resident was in bed. But the note also provides some interesting perspective on the resident's level of cooperation. This was at a time when, according to his treatment record, he was less compliant than at the time of the survey. The note discusses his verbal abuse, states that the resident "gets mad because he thinks he can walk," and "refuses to get up because he does not want the Hoyer lift." But it does not say that he refuses the heel protectors. In fact, just the opposite, the note says that the heel protectors are applied. I therefore conclude that Resident #4's purported resistence to care did not justify staff failure to follow the physician order to apply the protective devices while Resident #4 was in bed. See Crestview at 20-21 ("Crestview's assertion that Resident #68 may have removed her own protectors was not supported by anything in that patient's records or by a testimonial proffer from a facility staff member actually treating that patient nor is that explanation reasonable on its face in view of the circumstances of this patient and the number of pressure sores involved.")

With respect to Petitioner's argument about other, more effective interventions, Petitioner suggests that it "took appropriate steps" by "providing a pressure relieving mattress as a nursing intervention," citing P. Ex. 21, at 6, and P. Ex. 24, at 2. P. Brief at 75. I note that Petitioner has not exactly said that it provided the mattress as of the time of the survey, although its clear implication is that it had done so. But Petitioner relies on documents that do not show that the facility provided the mattress. The cited documents are the resident's Minimum Data Sheet (MDS) and his preliminary plan of care. They only refer generally to "pressure relieving devices for bed," as a means of addressing the resident's impaired skin integrity. They do not say that a pressure relieving mattress was ordered or provided. Had such mattress actually been provided, Petitioner presumably could have found staff able to testify to that effect, or could have produced a document dispositive of that issue.

Moreover, other evidence belies Petitioner's claim to have provided the mattress. Review of the physician order sheets for October and November list no pressure relieving mattress. P. Ex. 32. Apparently anticipating this problem, Petitioner points out that the facility could have provided the mattress without a physician order. I agree. However, Petitioner disregards completely the physician order dated November 18, 2000, after the date of the survey, calling for a "prime air mattress [related to] Stage IV pressure areas and multiple stage II's." P. Ex. 31, at 7. Dr. Hall, the facility medical director and Resident #4's attending physician, only discontinued his order for heel protectors on November 20, two days after he ordered the mattress. P. Ex. 31, at 11. Had an appropriate pressure-relieving mattress already been provided, it seems unlikely that the physician would have ordered a second one.

Petitioner also disregards an assessment form filled out by the nurse/sales representative who examined Resident #4 two days after the survey. Listed for check-off on that document are various interventions for prevention of pressure sores, and the assessor checks off those that have been implemented. In her assessment of Resident #4, dated November 18, Susan Chastain checks "heel pads" and "turn and reposition" under preventive care. She does not check "air mattress," which I consider further evidence that no such mattress had been provided. P. Ex. 37.

Petitioner makes a good case for the proposition that a pressure-relieving mattress would have been an appropriate intervention for someone as compromised as Resident #4. P. Reply Brief at 14, citing Tr. 137-138, 273. However, the record establishes that the mattress was not ordered until after the completion of the survey, when Resident #4's condition had deteriorated to the point that he had "stage IV pressure areas and multiple stage II's." Nor was the facility providing even the minimal protection of applying heel pads. See Tr. 273-274 (Parrish testimony: "At a minimum, the resident should have heel protectors or some other protection on the heel.")

Finally, even if Petitioner had shown that a mattress were provided, staff was simply not free to ignore the physician order for pads and heel protectors. See Crestview at 17-18 (Staff assertions that heel protectors were unnecessary held not competent evidence to counteract the effect of the physician's orders).

The surveyors were also disturbed by staff's - particularly LPN Smith's - apparent lack of understanding as to the severity of the deterioration to Resident #4's heel. On November 16, the surveyors noted a "strong, foul odor with red/tan/greenish drainage" on the left heel dressing. Although treatment staff identified and documented the wound as at stage II, the entire dermal layer was gone and there was tunneling. CMS Ex. 17, at 14-15; CMS Ex. 3, at 1. Surveyor Chuven explained that by November 16, the heel wound had "clearly" progressed to stage III; all of the skin was gone and the exposed tissue was "red, soft, and mushy." Yet, the treatment nurse claimed that the wound was only stage II because bone was not yet exposed. CMS Ex. 13, at 2, ¶ 10. (Chuven Declaration)

None of Petitioner's witnesses seriously argue that the condition of Resident #4's left heel wound was still at stage II by the time of the survey. In fact, within two days of the dispute between LPN Smith and the surveyor, both Nurse Chastain and Dr. Hall characterized the wound as stage IV. P. Ex. 37; P. Ex. 31, at 7.

Left hip/ thigh. When the surveyors observed Resident #4 in bed at 3:50 p.m. on November 9, they saw on his left hip/thigh, a stage II, dark red open area, larger than a dime, that had sloughing tissue in the center. The surrounding area had multiple small open areas. On November 16 at 10:14 a.m., the surveyors noted a foul odor and the dressing had tannish/green drainage, signs of infection. CMS Ex. 17, at 14; CMS Ex. 13, at 5, ¶ 23 (Chuven Decl.); CMS Ex. 3, at 10. Reviewing the facility's pressure ulcer weekly report, the surveyors determined that the wound was initially detected on October 23, when it was described as a stage II, 2 x 2, with serous drainage. (8) CMS Ex. 3, at 10. Although treatment was provided, the surveyors saw no physician's order for the treatment and determined that the physician was not aware of the wound. CMS Ex. 17, at 14. In this regard, I discuss below Surveyor Chuven's testimony about her conversations with Dr. Hall.

Right heel. On November 9 at 3:50 p.m., the surveyors noted on Resident #4's right heel, a dressing covering an area approximately 2" in diameter, that had black drying edges. CMS Ex. 17, at 15; CMS Ex. 3, at 1. According to Surveyor Chuven, the black area, called "eschar," is necrotic tissue associated with advanced pressure sores. CMS Ex. 13, at 5, ¶ 22 (Chuven Decl.).

In a report entry dated November 1, LPN Smith writes that the right heel wound was detected on October 30, and described as a stage I, 3 x 3 cm., with no drainage. CMS Ex. 3, at 10. Again, the physician was not informed that the wound had developed (see discussion below). A note dated October 31, 2000, indicates that Resident #4 was "seen by Dr. Hall," but "no new orders" were given. P. Ex. 34, at 8. Nevertheless, staff began treating the wound with Hypergel, a debriding agent. P. Ex. 33, at 2. Surveyor Chuven testified that a debriding agent is not normally considered an appropriate treatment for a stage I pressure sore because the goal at stage I is to protect and preserve living skin, not to debride necrotic skin or tissue. Use of a debriding agent, according to Surveyor Chuven, is likely to aggravate, rather than heal, a stage I pressure sore. Tr. 190; CMS Ex. 13, at 4-5, ¶ 21 (Chuven Decl.); see also CMS Ex. 10; CMS Ex. 17, at 15. Surveyor Chuven's opinion is supported by the literature, including the facility's own policies and procedures. Compare, e.g., P. Ex. 53, at 22 (debridement necessary at stage III) with P. Ex. 53, at 15, 17 (stage I and II treatment recommendations do not include debriding agents); see also CMS Ex. 10; P. Ex. 53, at 33. Surveyor Chuven also testified that a skin assessment dated November 8, 2000 indicated that the right heel wound had then progressed to a stage II pressure sore, measuring 3 centimeters by 2.8 centimeters (approximately 1˝ inches in diameter), with sero-sanguineous drainage (drainage consisting of clear fluid and blood). P. Ex. 59, at 7; CMS Ex. 3, at 12; CMS Ex. 13, at 5, ¶ 22 (Chuven Decl.).

Petitioner, however, points to another document prepared by LPN Smith, a different weekly pressure ulcer report. According to a November 1 entry on that document, the sore is 3 x 3 with no drainage or odor, but "eschar" is written in place of the stage. P. Ex. 27, at 5. As Petitioner points out, a wound covered by dead tissue cannot be "staged." P. Reply at 11-12. But Petitioner does not explain the inconsistency between the two reports, and I find it highly unlikely that a pressure sore would initially present as a wound covered by dead tissue.

Petitioner characterizes as "unclear" what additional interventions would have helped Resident #4 in light of his overall condition. P. Brief at 39. Of course, the heel pads should have been applied as ordered. Moreover, although CMS is not obligated to provide Petitioner with treatment recommendations, I note that the actions taken immediately following the survey suggest that a significant number of additional interventions were appropriate. The physician order dated November 18, 2000, called for the "prime air mattress [related to] Stage IV pressure areas and multiple stage II's." P. Ex. 31, at 7. A physician order dated November 16, 2000, says "clean R posterior foot with dermal wound cleanser, apply ABT ointment and bandaid" every day and as needed. P. Ex. 31, at 8. A series of physician orders dated November 19 discontinue "all previous skin treatments" and then set out six new treatments. (9) The orders include:

    •Cleanse L. trochanter with NS and apply thin layer of hypergel to area of slough and eschar, apply moisture barrier cream to surrounding skin, cover with Alldress;

    •Cleanse L. heel with NS and apply thin layer of Hypergel, apply moisture barrier cream to surrounding area, cover with Alldress and change every day;

    •Cleanse R heel with NS daily - no dressing;

    •Cleanse L Lat. Malleolus with NS and apply Alldress and change every day;

    •Cleanse wound to L upper back with NS and apply Mitraflex Plus. Change every 5 days and as needed; and

    •Cleanse R ft. with NS. Cover and secure. Change every day.

P. Ex. 31, at 10. Ultimately, a physician note and order dated November 20, transferred Resident #4 to hospice care, where, by all accounts, his skin breakdowns improved and he did relatively well. P. Ex. 30, at 8-9; P Ex. 31, at 7, 11; see P. Brief at 38, note 17. (10)

With respect to Petitioner's general claim that "virtually all of the residents at issue suffered from chronic skin problems - not new pressure sores" (P. Brief at 23), Resident #4's wounds (like those of Resident #1) were undeniably pressure sores. Indeed, notwithstanding its frequent references to Resident #4's vascular disease, Petitioner does not claim otherwise. (11) The sores were "staged," a process appropriate for pressure ulcers, but not other types of wounds (P. Ex. 53, at 3), and, throughout his treatment record, the wounds are identified as pressure ulcers. P. Ex. 27; P. Ex. 28, at 13, 14; P. Ex. 29; P. Ex. 30, at 4; P. Ex. 31, at 7 ("stage IV pressure areas and multiple stage II's").

c. The facility delayed treating Resident #5's pressure sores, provided treatment without a valid physician order, and its treatment nurse impermissibly altered a treatment record.

Resident #5 was a 71-year-old double amputee with peripheral vascular disease, and diabetes. He was incontinent and at high risk for developing pressure sores. P. Ex. 84, at 2, 10. Review of his treatment records shows that throughout August, September, and the beginning of October 2000, he had recurring problems with pressure sores on his coccyx and buttocks. P. Ex. 84, at 6-7, 9, 10-15. In a weekly pressure ulcer progress report dated October 1, 2000, LPN Smith reports a red, 1.5 x 1 cm. stage II pressure ulcer with serous drainage on Resident #5's coccyx. P. Ex. 84, at 15. On October 9, 2000, the LPN describes that wound as "healed." P. Ex. 84, at 7, 15.

A skin assessment dated October 22, 2000, signed by Shasta Walker, indicates under buttocks and hip area, "small red open area." P. Ex. 84, at 10. An assessment dated October 29, 2000, also signed by Shasta Walker, indicates "open area on coccyx." P. Ex. 84, at 10. In an assessment dated November 2, 2000, Shasta Walker describes a "red open area on coccyx." P. Ex. 84, at 12. At about the same time that Shasta Walker was documenting the presence of these "open areas" on his coccyx, however, LPN Smith was only describing "discolorations" to the hip and buttocks areas. P. Ex. 84, at 11 (assessments dated 10/25 and 11/1).

On her weekly ulcer progress report dated November 7, 2000, LPN Smith describes a red, .8 x .6 cm. stage II pressure sore with serous drainage. P. Ex. 84, at 15. But, on a skin assessment dated the same day, she inconsistently checks only "discolorations" to the hip and buttocks. P. Ex. 84, at 13.

The surveyors observed Resident #5 at 4:20 p.m. on November 9. He had two open areas on his sacrum, to which no dressing had been applied. Nursing staff told the surveyors that the wounds were at stage II and were treated with barrier cream. Later, at 7:30 p.m., staff told the surveyors that the wounds were treated with derma wound cleanser, Normigel and Alldress. But the resident's treatment record contained no physician order for this treatment. According to the surveyors, a prior treatment order was discontinued on October 31, 2000. CMS Ex. 17, at 10. Review of the resident's treatment record confirms that the prior treatment order was discontinued on October 31, 2000. P. Ex. 88, at 1.

Staff obtained a treatment order on November 9. P. Ex. 88, at 1. However, as set forth in the statement of deficiencies, and as Surveyor Chuven explained, treatment records show that at least one pressure sore was observed two days earlier, on November 7. Tr. 163; P. Ex. 84, at 15; CMS Ex. 17, at 15. The facility allowed the wound to go untreated or minimally treated for two days. P. Ex. 86, at 3.

Petitioner claims that no wound was observed until November 9, and submitted a note that appears to be dated November 9, signed by LPN Smith, describing the wound. P. Ex. 84, at 7. Surveyor Chuven, however, testified that the note was altered after she reviewed it on November 13. She produced a photocopy of the document she reviewed, which indicates, on its face, that she photocopied it on November 13. The document reads:

11/7/00 Res coccyx has reopened measure .8 X .6 [with] serous drainage. Tx cont as written. Normigel/Alldress.

The entry is signed D. Smith LPN. ALJ Ex. 1, at 2. According to Surveyor Chuven, on November 16, the facility produced a second version of the document in which the 7 had been changed to a 9 so the date reads "11/9/00." ALJ Ex. 1, at 1. The change is not initialed, nor does the document indicate that it was so altered. Indeed, the change appears to have been made very carefully so that it appears that 11/9/00 was always the date written. Without both versions of the document, the observer would assume that the wound was first noticed on November 9. Tr. 163. Compare ALJ Ex. 1, at 1, with ALJ Ex. 1, at 2.

In yet another version of this document, which Petitioner submitted as an exhibit, the date "11/9/00" is crossed out and "Error D.S." is written in, and below that "11/9/00" is written. P. Ex. 84, at 7. D.S. is Deborah Smith. Tr. 167.

Following the hearing, Petitioner submitted supplemental declarations from LPN Smith and from Jillene Snow, a registered nurse and vice president for clinical services for the Southeast Region of SunBridge HealthCare Corporation. Snow Decl. at 1. RN Snow was not present during the survey, but went there after and was there a day or two a week for several weeks. Tr. 212-213. (12) In her declaration, LPN Smith admits that she changed her note, but claims

I was careful to write that the original date was an error. What happened was this: November 9, 2000 was a chaotic day for me because of the survey, which seemed to focus on me and my abilities. Resident #5 had chronic skin breakdowns on his coccyx area. Some time on November 9, the same day the survey started, a nurse named Cheryl Horton noted that a wound in that area had opened, and she obtained treatment orders from the resident's attending physician, and provided the ordered treatment. At some point that same day, Nurse Horton related this information to me, and I made an entry in my notes, but I obviously wrote the wrong date. When I reviewed my notes later - even before I became aware that the surveyor was making an issue of when order [sic] had been obtained and the treatment had been provided - I discovered my error, and simply corrected it. I was careful to note that the original date was an error. It is obvious now that the surveyor already had copied my notes by that point, but she never asked me about the date at the time, so when I corrected the date, I gave the matter no thought. I am sorry if this caused confusion, but in no way did I intend to do anything improper, or to change a medical record to show that the skin breakdown occurred two days after it did.

Smith Decl. at 2, ¶ 4.

I find this statement not credible. First, it does not explain the document that Surveyor Chuven photocopied on November 16, which shows the alteration of the date, without any mention of an error. ALJ Ex. 1, at 1. Second, the final version of the document, P Ex. 84, at 7, shows the date "11/9/00" crossed out with "error" written in and the date "11/9/00" then written in, which seems pointless. Why "correct" a date with the same date? Nothing on that document suggests that the 11/7 date had ever been written in. Third, other treatment records, including LPN Smith's own weekly pressure ulcer progress report, plainly record the presence of a pressure sore on Resident #5's coccyx on November 7 and even earlier. P. Ex. 84, at 15 (describing a stage II ulcer measuring .8 x .6 with serous drainage). Indeed, the Shasta Walker assessments describe open sores on 10/22, 10/29, and 11/2. P. Ex. 84, at 10, 12.

Nor does LPN Smith adequately explain the timing of her "correction." We know that the entry read "11/7/00" as late as November 13, when Surveyor Chuven made her copy. LPN Smith altered the document sometime between November 13 and November 16. I find it unlikely that she was not aware earlier that the surveyors were "making an issue" of when Resident #5's treatment began and when the treatment order was obtained, particularly since the surveyors "made an issue" out of it on the first day of the survey, November 9.

Petitioner refers to a nursing note dated November 9, signed by Cheryl Horton LPN, describing two open areas on Resident #5's coccyx. The note was written at 8:00 p.m., almost four hours after the surveyor observations, and indicates that LPN Horton "will notify" the treatment nurse. P. Ex. 87, at 2. At best, this only establishes that hours after the surveyors noted the wounds and the absence of a treatment order, LPN Horton contacted the physician and made a note of it. The note also confirms that staff did not notify the physician or obtain a treatment order until November 9. It does not respond to the numerous notes and assessments documenting the presence of an open sore prior to November 9.

The more reliable evidence establishes that Resident #5 had an open pressure sore on his coccyx at least as early as November 7, and likely well before. The evidence also conclusively establishes that LPN Smith altered one of the treatment records to reflect that the pressure sore developed on November 9.

Petitioner seems to argue that I may not consider evidence of the altered record. I disagree. Petitioner's own employee created all three versions of the note (ALJ Ex. 1, at 1, ALJ Ex. 1, at 2, and P. Ex. 84, at 7), and thus Petitioner is charged with knowledge of their contents and the circumstances surrounding their creation, and should not have been surprised that the issue arose. I also afforded Petitioner the opportunity to supplement the record in order to explain the discrepancies, which Petitioner took advantage of. Further, the record alteration merely addresses the question as to the reliability of the document. Petitioner has not been cited for altering a clinical record (see 42 C.F.R. § 483.75(l)). Adding that charge would have created an additional issue, which is permissible but requires additional notice. 42 C.F.R. § 498.56. And even without the evidence of the altered document, Petitioner has proffered inconsistent documentation as to Resident #5's condition from late October through the date of the survey. Such evidence does not overcome CMS's showing that the facility delayed treatment of Resident #5's pressure sores.

Finally, Resident #5 may well be the type of resident Petitioner was referring to when it claimed that the residents suffered from "chronic skin problems - not new pressure sores." P. Brief at 23. Resident #5 was obviously at high risk for developing pressure sores, and apparently had previously developed them in the same place. I do not agree with the facility's suggestion that the recurrence of a pressure sore excuses it from immediately notifying the physician, and obtaining and implementing treatment instructions. Surveyor Chuven testified that the physician should be notified without regard to whether the sore has developed on the site of a previous sore or has developed at a previously intact site. CMS Ex. 13, at 5, ¶ 26. I agree. If anything, a resident's demonstrated vulnerability should increase the facility's vigilance in preventing and treating pressure sores.

d. The facility did not take necessary precautions to promote healing and prevent infection of Resident C's pressure sores.

Resident C is also identified as Resident #7 and by her initials. Her daughter, Jeanette Anderson, was one of the individuals who triggered the State Agency investigation by complaining that her mother was often left lying in waste, and had developed multiple pressure sores and infections. Tr. 207; CMS Ex. 8, at 1, 7.

Resident C was an 83-year-old woman with multi-infarct cerebral vascular disease, dementia, diabetes, and a history of urinary tract infections. CMS Ex. 8, at 11. She was totally dependent on staff for activities of daily living. CMS Ex. 8, at 8. She was incontinent. CMS Ex. 8, at 9. On what appears to be September 7, 2000, staff noted a 2 x 2 cm. "blackish closed wound to the right ischium" (inferior dorsal portion of hip bone). According to the nurses note, staff cleaned the wound with dermal wound cleanser, applied a dressing to the area, and notified the treatment nurse "via red alert book." CMS Ex. 8, at 5. A September 13 note by LPN Smith measures the right hip wound at 1.5 x 1.5 cm. with serous drainage. The wound bed is red, but without odor. "Tx cont. as written." Treatment appears to be Hypergel and Alldress. CMS Ex. 8, at 6. On September 20, and again on September 27, the wound measures 2 x 2 cm. with serous drainage, red wound bed, and a "small amount" of yellow slough. Id.

Just five days later, on October 2, Resident C was admitted to the hospital with an infected pressure sore, dehydration, and malnutrition. CMS Ex. 8, at 5, 11-13. Upon admission, she had a stage III decubitus on her right hip, with minimal drainage and necrotic tissue. CMS Ex. 8, at 12. She had stage I decubiti on her left hip, and on her sacrum. She had erythema on the medial surface of both ankles. CMS Ex. 8, at 12. Her right hip decubitus was infected with Proteus, a pathogenic (disease causing) germ typically found in feces (CMS Ex. 15, at 1, ¶ 5) and MRSA (methicillin resistant staph aureus). She also had a urinary tract infection. The hospital treated her with IV antibiotics, frequent changing and dressing of her wound, and constant turning to prevent the development of additional decubiti. The hospital inserted a peg tube for feeding and the administration of medications. CMS Ex. 8, at 7

Resident C returned to the facility on November 2. According to LPN Smith's notes, she still had stage II sores on her right ischium and sacral area. CMS Ex. 8, at 6. But according to an enteral nutrition worksheet, dated November 3, 2000, Resident C then had a stage III sore on her right hip. CMS Ex. 8, at 10. On November 8, LPN Smith described the sacral wound as stage II, measuring 2.8 x 3 cm., with serous drainage. CMS Ex. 8, at 9.

The surveyors observed Resident C on November 9 at 4:30 p.m. They noted that a dressing to her sacral region was loose, and that it had not been dated. The standard of care requires that a dressing be dated so that staff know when it was applied. Tr. 134. The surveyors saw feces on the dressing and the exposed wound area. CMS Ex. 17, at 9-10. They concluded that the wound was not protected from contamination. CMS Ex. 8, at 2, 3; CMS Ex. 17, at 9-10. Resident C's family was present and complained of finding their mother lying in urine and feces. They also complained that they could not find staff to clean her. CMS Ex. 8, at 4.

In her testimony, Ms. Anderson confirmed her family's complaints to the survey team. She testified, credibly, that she visited her mother three or four times a week, and that a family member visited every day. She said that she often found her mother lying in her own waste. Family often bathed her themselves, and changed her soiled linen. They prompted staff to clean her feeding tube. CMS Ex. 14 (Anderson Decl.); Tr. 197; see also CMS Ex. 8, at 8 (per social service notes, "family visits frequently").

Ms. Anderson testified that immediately prior to her mother's hospitalization, family members found her very ill and insisted that she be transferred to the hospital. At the hospital they found that she had a urinary tract infection, as well as other infections. "They had to clean her up before they would do anything because she was smelling so bad. It was terrible." Tr. 205.

I am not persuaded by Petitioner's attacks on Ms. Anderson's credibility. Petitioner suggests that the family's allowing Resident C to remain in the facility undermines Ms. Anderson's credibility. I disagree. The transfer of an elderly and infirm individual is no small matter, particularly where, as here, the resident had a longstanding connection to the facility; she had worked there for about 12 years, and began residing there in 1996, and considered it "home." Tr. 196, 203. The facility was in a convenient location for many family members. Id. Moreover, the family's response to the treatment provided does not suggest its approval of that treatment. Family members, including Ms. Anderson, advocated for their mother; they cared for her themselves when necessary; and, when dissatisfied, they complained to the proper authorities.

Petitioner alleges inconsistencies in Ms. Anderson's testimony that are simply not there. In her declaration, Ms. Anderson declares, among other complaints, that she and her family had to prompt facility staff to clean her mother's feeding tube and other tubes. CMS Ex. 14, ¶ 3. In another paragraph she says that "many times when I visited, particularly on weekends, there was only one aide on duty to take care of the entire east wing." CMS Ex. 14, ¶ 4. Petitioner asserts that the resident did not have a feeding tube or catheter until her hospitalization and that only one weekend elapsed between her readmission to the facility and the survey. If Petitioner is suggesting that Ms. Anderson only visited on weekends, that is not what she said. She said that she visited three to four times a week, and that shortage of staff was particularly acute on weekends.

Petitioner points out that Ms. Anderson also testified that the facility sometimes provided her mother good care, and alleges that Ms. Anderson has confused her dates, and was really satisfied with her mother's care up until the months surrounding her mother's death in November 2001. I do not think this accurately reflects Ms. Anderson's testimony. She explained that there were periods when she was satisfied with the care her mother received. But there were other times when she was clearly not satisfied, and the record leaves no doubt that prior to October 25, 2000, when she complained to the State Agency, and at the time of the survey she was very dissatisfied with her mother's care. CMS Ex. 8, at 1, 4; Tr. 205-207. She said that "everything was fine for about three months" and identified "April, May, and June" as months in which everything was fine. Tr. 203. Petitioner correctly points out that Ms. Anderson also testified that her mother's care deteriorated in September 2001. However, that she was extremely unhappy with the care her mother received in 2001, does not detract from her unambiguous testimony and the surveyor documentation that in October and November 2000, she complained that her mother was left lying in waste, resulting in the contamination of an open pressure sore.

Petitioner has produced no witness charged with Resident C's care to contradict either Ms. Anderson or Surveyor Chuven. The record thus establishes that in October 2000, Resident C had open wounds on her hips and sacrum, and that one of those wounds became infected by a germ typically found in feces. The obvious inference from this is that she got a Proteus infection from fecal contamination, which is consistent with both Ms. Anderson's testimony of finding her mother lying in urine and feces, and with the surveyor observation of a fecally contaminated wound.

The facility does not dispute the surveyor observation as to the loose, undated dressing and fecal contamination on Resident C's sacral wound, but, according to RN Snow, this observation is "immaterial to the Resident's clinical problems." In a remarkable declaration, RN Snow, Petitioner's corporate vice president for clinical services, states:

Finally, the fact that a dressing came loose on one occasion during the survey, presumably accidentally and inadvertently, strikes me as immaterial to the Resident's clinical problems. Residents move in bed, receive treatments, etc., and wound dressings do sometimes come loose; when a nurse sees a loose dressing, she should change it. But a loose dressing obviously did not cause the Resident's longstanding skin breakdown, and temporary contamination of a wound that already was infected would be extremely unlikely to cause any further harm. Similarly, if the Resident's wound already was infected, her entire body was exposed to the infectious agent, so a loose dressing did not make the situation worse. While it would be desirable if dressings never came loose, I simply cannot see how a loosened dressing constitutes a deficient practice, much less one that exposed the Resident to "immediate jeopardy."

Snow Decl. at 17-18, ¶ 54.

As a factual matter, I note that the sacral wound was not "already infected." The infected wound was on Resident C's right hip. Moreover, this resident was recovering from a serious infection, most likely caused by fecal contamination. That she was then subjected to feces on an open wound, whether the same or a different wound, can hardly be considered "immaterial" to her clinical problems. I frankly agree with CMS that RN Snow's contention is fundamentally flawed and reflects ignorance of basic infection control and the resident's medical history. As Surveyor Chuven observed, responding to a question about the harm or potential harm that could be caused by the loose soiled dressing, this was an already debilitated resident and the introduction of infection into a non-infected wound would be further debilitating. Tr. 158.

Dr. Timothy Holtz is a Board-certified internist employed by the United States Center for Disease Control and Prevention (CDC). He described the danger of infection from fecal contamination:

[I]n fact, if anything, if you already have one infection that will decrease your immune system's response to fight off any other infection. . . . [Y]ou can have multiple infections in the same wound at the same time. So, if anything, it would make the person more - possibly more susceptible to getting an infection.

Tr. 132. Dr. Holtz also described the ordinary treatment for a skin breakdown infected with MRSA: application of a dressing to prevent any further skin breakdown, dressing changes on a regular basis, regular inspection, keeping the area clean, treatment with antibiotics such as Vancomycin or other strong antibiotic directed particularly at MRSA. Tr. 133. According to Dr. Holtz, the standard of care for dressing changes is usually once per day, although, under some circumstances, they might need to be changed more frequently. And they are dated at the top so that you know when the dressing was applied. Tr. 134.

Thus, the record establishes that Resident C had multiple pressure sores. One was infected with bacteria found in feces. Unrebutted testimony establishes that the resident was allowed to lie in her own urine and feces. Also unrebutted, the surveyor observed on the first day of the survey that a second wound was exposed to fecal contamination. Petitioner's corporate nurse asserts that such fecal contamination does not present a serious problem. The CDC physician explains that, to the contrary, it presents a potentially very serious problem. All of this is consistent with the conclusion that the facility was not taking necessary precautions to promote healing and prevent infection of Resident C's pressure sores.

e. The facility did not take necessary precautions to promote healing and prevent infection of Resident #22's pressure sore.

Resident #22 was an 85-year-old woman with a history of stroke and dementia. She had a feeding tube and was incontinent of bowel and bladder. P. Ex. 106. According to her MDS form, as of November 4, 2000, she had no pressure sores or other skin problem, and received no skin treatment. P. Ex. 106, at 6.

On November 16, Surveyor Chuven observed a stage II pressure sore on Resident #22's left buttock. The wound was not covered with any dressing. Staff told the surveyor that the area was being treated with barrier ointment alone because the wound had no drainage. Staff explained the absence of a treatment sheet by claiming that the direct care staff, who applied the ointment, "knew what to do." Later, the CNA who was caring for Resident #22 denied that the resident had a skin breakdown or received any special care. CMS Ex. 17, at 12.

In these proceedings, Petitioner denies that Resident #22 had a skin breakdown at the time of the survey, presenting the testimony of Nurse Parrish, who said that when he examined Resident #22 on November 18, 2000, he noted no breakdown at all. Tr. 252; P. Ex. 111.

But the clinical record supports the surveyor observation and does not support Nurse Parrish's assertion. Treatment notes for this resident dated November 10, 2000, report: "pressure sore noted on resident's lower bottom (buttocks) dressing applied." P. Ex. 107, at 1. A dietary progress note, dated November 17, 2000, the day after Surveyor Chuven documented her observation, says "[Checked] pressure sore on lower bottom. Dressing applied," and "skin should heal quickly - continue current POC & follow." P Ex. 108, at 1.

Petitioner dismisses the nursing note as wrong, based on Nurse Parrish's claim that pressure sores could not develop on the buttocks, and gratuitously asserts that the dietary progress note "probably simply repeated verbatim the reference in the November 10 nursing notes." P. Brief at 68, note 24. As discussed above, I have rejected Nurse Parrish's unsupported assertions with respect to whether a pressure sore can develop on the buttocks, in favor of other, more compelling evidence in the record - including the facility's own policies and protocols - showing that buttocks are vulnerable to the development of pressure sores. See P. Ex. 56, at 5. I also reject Petitioner's unsupported efforts to impeach its own treatment records. The names of the facility staff members who made and recorded their observations are clearly noted next to their entries. The facility was free to call J. Dodson to disavow her nursing note, and to call Lynn Shaw, the Registered Dietician, to explain that she simply copied a week old note without any independent verification. Petitioner failed to do that, so we are left with two apparently independent observations by facility employees that support the surveyor observation. By at least a preponderance of evidence, the record shows the presence of a pressure sore at the time of the survey. (13) Staff did not notify the physician and were treating it without a physician order, and without documenting what they were doing.

f. The facility did not take necessary precautions to promote healing and prevent infection of Resident #27's pressure sore.

Resident #27 was a 90-year-old woman who suffered from complete bowel incontinence. P Ex. 118, at 1-2. On November 16 at 3:10 p.m., the surveyors observed that she had a stage II pressure sore, approximately Ľ" in diameter, on her buttock. They reviewed skin assessments dated October 29, November 2, and November 11, which documented the existence of the open area. However, the treatment sheet showed that the facility did not initiate treatment until November 15, 2000. CMS Ex. 17, at 14; CMS Ex. 13, at 3, ¶ 13 (Chuven Decl.)

The facility's assessments and treatment record confirm the surveyor observation. An assessment dated October 29, 2000, signed by Shasta Walker, describes "small red open area left buttock." CMS Ex. 5, at 1. Another assessment, dated November 2, 2000, describes "red open area on left buttock." CMS Ex. 5, at 2. A third assessment, dated November 11, and signed by Shasta Walker, also describes "red, open area on left buttock." Id. The treatment record includes a treatment order dated November 14, and shows that the ordered treatment was first administered November 15. ("Clean (L) buttock [with] dermal wound cleanser, apply Normigel [and] Alldress [every day and as needed].") In an entry dated November 15, LPN Smith describes the sore as "stage II . . . with serous drainage measur[ing] 1 x 1." She also writes "Tx ordered as written." CMS Ex. 5, at 4.

Two days after the survey, Nurse/Sales Representative Chastain confirmed the presence of a stage II pressure sore on Resident #27's left buttock, measuring 1 x 0.8, and describes a stage II pressure sore on the resident's left heel, measuring 1.7 x 2.0. CMS Ex. 5, at 5. (14)

The resident was incontinent. She had an open wound on her buttocks which the facility did not begin to treat for two weeks. Based on these facts, I conclude that the facility was not taking necessary precautions to promote healing and prevent infection of Resident #27's pressure sore.

2. The facility routinely failed to consult the resident's physician when a new pressure sore developed, and staff treated pressure sores without a valid physician order.

The regulations require that the facility consult the attending physician whenever there is a significant change in a resident's status or whenever there is a need to alter treatment significantly, i.e., "a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment." 42 C.F.R. § 483.10(b)(11). In its brief, Petitioner appears to concede, based on a reference to the State Operations Manual (SOM), that the development of a stage II pressure ulcer is a "clinical complication" that should be reported to the attending physician. P. Brief at 23, citing SOM PP-12, P. Ex. 134. Petitioner's own protocols provide that the attending physician be notified of the development of a stage I pressure ulcer, as well as stages II, III, and IV. P. Ex. 53, at 14, 16, 20, 25.

Petitioner's protocols also provide that

medical treatment will be ordered by a physician and transcribed onto the treatment records. The licensed nurse or therapist will document on the resident treatment sheets each time the treatment is completed.

P. Ex. 53, at 7. Further, a treatment order from the physician

will be obtained for the residents assessed with pressure areas. This is the responsibility of the licensed nurse who discovers the pressure area. It is not to wait for the facility's skin integrity coordinator.

(Emphasis in original) The protocol also requires that all treatment orders be documented on the treatment administrator record (TAR) for individual residents. P. Ex. 53, at 5.

The facility protocol is consistent with standard nursing home practice. Surveyor Chuven is in a position to know the practices in nursing homes inasmuch as she has surveyed so many of them. She characterized as "standard" the nursing home practice of notifying a resident's physician when the resident develops a pressure sore, without regard to whether the sore has developed on the site of a previous sore, or has developed at a previously intact site. CMS Ex. 13, at 5, ¶ 26 (Chuven Decl.)

Dr. Holtz agreed that the standard of practice requires physician notification, testifying that he considered it a "high priority" to notify the physician whenever a decubitus ulcer develops, characterizing that event as "sort of a warning sign or a red flag that proper nursing care is not being delivered." Tr. 139. Dr. Holtz testified that when any recurring wound opens up - whether or not a pressure sore - the standard of care requires that the physician be notified, and explained that skin breakdown creates risk of infection, which affects the physician's delivery of care to the patient. Tr. 140. He explained that, while standing orders are appropriate for routine care, it would not be appropriate to follow a standing order when a wound reopens; the physician should be contacted. Tr. 142.

Notwithstanding its own protocol, which Petitioner argues staff were free to ignore, the facility routinely failed to notify the attending physician that a new pressure sore had developed. Staff began to treat wounds without physician notification or involvement. Surveyor Chuven testified that staff told her that they routinely wrote orders for pressure sore treatment, and that the physician was not consulted about changes in the status of pressure sores or the need to alter treatment. Tr. 116, 186. This record is replete with examples of that practice, many of which I have already discussed.

The surveyors, for example, found no physician orders for treating the infected ulcer that had developed on Resident #4's left hip and thigh, nor for treating the ulcer on his right heel. Surveyor Chuven testified that she spoke to Dr. Hall, Resident #4's physician, who told her that "he was aware" of the resident's condition. They discussed the left heel, which Dr. Hall had been treating, but when Surveyor Chuven asked him about the hip and thigh area and the right heel, "he got silent for a minute and told me he was not aware of those." Tr. 112; see CMS Ex. 4, at 1. I found this testimony credible, and consistent with the record evidence.

Weekly reports on the progress of Resident #4's left thigh wound indicate that neither the physician nor family were notified of that wound. P. Ex. 27, at 4-5; CMS Ex. 3, at 13-14. The weekly report form specifically asks for the dates that "dietary/physician/family" were informed. But no date is filled in. Instead a line is drawn through. Similar forms relating to Resident #4's right heel wound indicate that neither dietary, physician, or family were notified. P. Ex. 27, at 5.

Citing a physician order dated August 8, Petitioner argues that the record "makes clear" that Dr. Hall was aware of the right heel wound. P Ex. 31, at 1; P. Reply at 9. Inasmuch as the right heel wound did not even develop until the end of October, this August 8 order does not establish that Dr. Hall was timely informed of it. The physician order dated August 8, 2000, obviously refers to a different wound. It says to clean the right posterior foot with NS (Neosporin?), and apply ABT ointment and a band-aid every day. P. Ex. 31, at 1. A physician order dated September 22 discontinues that order. P. Ex. 31, at 5. An October 18 physician order also says to discontinue treatment to the right posterior foot. P. Ex. 31, at 6. None of these in any way address the pressure sore that developed on Resident #4's right heel on October 30, for which Petitioner has produced no treatment order or other record of physician involvement in its treatment.

The record presents additional examples of the facility's failure to consult the attending physician when pressure sores developed. Resident #1's pressure sore was observed a full week before the physician was advised. Although staff identified open pressure sores on Resident #5's sacrum at least as early as November 7, they did not notify the physician or obtain a treatment order until late in the day November 9. CMS Ex. 17, at 10; P. Ex. 84, at 10, 12, 15; ALJ Ex. 1, at 2. At the time of the survey, Resident #22 had a pressure sore which staff were treating on their own, without notifying the physician and without a physician order. P. Ex. 107, at 1; CMS Ex. 17, at 12. Staff documented the presence of an open sore on Resident #27's buttocks more than two weeks before they obtained a physician's treatment order. CMS Ex. 5, at 1, 4.

Although Petitioner asserts generally that Dr. Hall "was aware," of the residents' conditions, it defends the practice described by Surveyor Chuven. Dr. Hall was the facility's medical director and the treating physician to many of the residents discussed in the survey. In his declaration, he does not assert that in any of the individual cases cited he was specifically informed that a particular pressure sore or other wound had developed. To the contrary, he suggests that many of the wounds in question were "chronic and persistent" and asserts that he did not need to be informed because "I would not consider the reopening of a chronic wound a 'change' in a resident's condition." Hall Decl. at 2, ¶ 6. He also concedes that he frequently relied on the report and recommendation of the wound care nurse and instructed the facility to follow her instructions. Hall Decl. at 2, ¶ 4.

RN Parrish agreed, and testified that even when facility staff called the physician's office, the nurses regularly determined the appropriate treatment, without advising or consulting the physician. Treatment was thus regularly provided without the physician's knowledge or consent. Later, the physician could learn of and sign the order. According to RN Parrish, the practice is appropriate because the nurses were in a better position than the physician to know how to treat wounds.

Witness: Now what the nurse in the doctor's office - sometimes they know what the doctor would recommend by habit and they'll go ahead and give them a verbal order.

* * * *

Question: Without consulting the doctor?

Witness: That's right.

Question: And that's appropriate?

Witness: That's appropriate.

Witness: Not that they don't tell them at a later time. They have to keep - they are supposed to keep a record there at the physician's office of what transpired and write it down.

Question: What's the point of requiring a doctor's order if the nurse is able to give it?

Witness: Well, ma'am, I'm just telling you the facts. I know a lot of times if I call down to the doctor and I know I've got a sinus infection, I'll talk to the nurse and she'll - - the first thing she'll do is, she says where is your pharmacy, and she'll turn right around and call me in a prescription.

Tr. 263-266. (15)

Petitioner suggests that the physician was simply too busy to be involved whenever a resident developed a new sore that required treatment, or needed a new treatment order. It sees nothing wrong with this "ordinary practice for communicating problems and orders between nursing facilities and outside attending physicians." P. Reply Brief at 8. First, I note that Dr. Hall was not an "outside attending physician." He was the facility's own medical director. Moreover, while I recognize that nurses regularly transmit information, questions, and orders between the facility and the doctor, and I recognize that some delegation of the physician's authority may be appropriate, the regulation requires that the communication be made to the physician, and that he, in fact, be consulted. Here, notwithstanding the facility's "state of the art" policies and protocols - which required maximum physician involvement - Dr. Hall and the facility apparently disregarded those policies and the regulatory requirements, and put in place a system that allowed his exclusion from the process. CMS has established many examples in which no documentary evidence supports the claim that the physician was consulted or even notified of changes in condition and the implementation of new treatments. Instead, an LPN with minimal training in wound care was diagnosing the condition and writing the treatment orders.

I am not persuaded that physician orders were lost, and I reject the wholly unsupported suggestion that the surveyors were somehow responsible for the facility's inability to produce physician orders. From the first day of the survey, the facility was put on notice that the absence of physician orders was a serious problem. It could not produce them then, nor at any time throughout this process. Although he was in the facility immediately after the survey, RN Parrish testified that he did not know whether there were physician orders for the treatments provided. He did not check. "That wasn't in the scope of what I was trying to do." Tr. 268-269.

B. The facility did not insure that residents who were unable to carry out activities of daily living received necessary services to maintain good grooming and personal hygiene, as required by 42 C.F.R. § 483.25(a)(3).

CMS cites specific surveyor observations of four residents whose nails were long and dirty. The Statement of Deficiencies is very specific: on November 9, 2000, at 4:30 p.m., and again at 6:58 p.m., they observed Resident #1. She had long fingernails, with dark brown matter under the nail tips. On November 13 at 12:20 p.m., they observed her again in bed, feeding herself, and she still had brown matter under her finger nails. Her records indicated that she was totally dependent on staff for personal hygiene. CMS Ex. 17, at 8.

During their initial tour of the facility on November 9, at 3:45 p.m., staff observed Resident #2 with long fingernails, and brown matter under the tips. At 3:00 p.m. on November 13, the nails were still long and dirty. Resident #2 was dependent on staff for personal hygiene. CMS Ex. 17, at 8-9.

On November 9 at 4:05 p.m., the survey team observed Resident #3 in bed, with "long, jagged nails" on both hands, and brown matter under the finger tips. At 8:15 a.m. on November 13, she was in bed, eating breakfast with her fingers. Her nails were still long with brown matter under the tips. She was also dependent on staff for personal hygiene. CMS Ex. 17, at 8. The nails were clipped an hour and a half later, but the resident had eaten breakfast using her fingers with dirty nails. Tr. 147.

The surveyor observed Resident #4 at 3:50 p.m. on November 9, with long fingernails on both hands. The nails on the right hand had brown matter under the tips. Because his left hand was contracted, the nails were digging into the palm of his hand. At 8:20 a.m. on November 13, his nails remained long. On November 16 at 10:14 a.m., two of the nails on Resident #4's left hand were still long, and the surveyor observed a "dark red, deep imprint of the nails in his palm." CMS Ex. 17, at 8; Tr. 148-149. He was, of course, dependent on staff for personal hygiene. Petitioner argues that Resident #4's circulatory ailments made trimming his nails "extremely problematic." P. Brief at 82. Although that fact might explain why the nails had not been trimmed adequately, it does not excuse the facility from keeping this man's nails clean and trimmed. If, in fact, such grooming presented extraordinary problems, his care plan should have addressed that issue.

Petitioner again does not directly challenge the surveyor observations, claiming that it is "unable to respond to specific allegations regarding surveyor observations that SunBridge employees did not see." P. Brief at 82. Had the facility kept its residents' nails clean and well-trimmed, it presumably could have produced staff willing or able to say so.

Noting that facility staff eventually cleaned and trimmed the nails of these individuals, Petitioner expresses confusion as to why "a handful of isolated observations of grooming issues over three days" should constitute a deficiency. P. Brief at 83. While the deficiency may not have been as serious as those surrounding the facility's approach to pressure sores, the facility is simply not free to ignore the needs of those individuals totally dependent on staff for all grooming. Each resident had the right to the dignity of well-maintained nails. Dirt under the fingernails can present hygiene issues, particularly for those residents who use their fingers to eat. I note also that Resident #4's nail grooming was not merely a question of aesthetics nor even of hygiene. Because his fingers were contracted, his nails required proper trimming to prevent what the surveyors observed - nails digging into the palms of his hand, causing discomfort and risking injury.

The facility's failure to maintain clean and well-trimmed nails for these residents, who were totally dependent on staff for personal hygiene, violates 42 C.F.R. § 483.25(a)(3).

C. The facility failed to develop and implement policies and procedures that prohibited the neglect of its residents, violating 42 C.F.R. § 483.13(c).

Section 483.13(c) requires that the facility develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents. The regulation "addresses a deficiency related to lack of an effective policy as opposed to one directed at the occurrence of neglect itself." Emerald Oaks, DAB No. 1800, at 17 (2001). CMS concluded that, in contravention of 42 C.F.R. § 483.13(c), the facility had not developed and implemented written policies and procedures that prohibited the neglect of its residents, based on: 1) the facility failure to consult with physicians after a significant change in a resident's condition, or when there was a need to initiate or alter treatment; 2) the facility failure to provide necessary care and treatment to residents with pressure sores; 3) the facility failure to meet the grooming needs of residents; and 4) the facility failure to provide sufficient qualified staff and/or supervision to ensure that residents received the necessary care and treatment of pressure sores, or to ensure that the residents' grooming needs were met. CMS Ex. 17, at 5.

Here, the facility unquestionably possessed written policies and procedures, and no one has suggested that they would not have been adequate had they been implemented. The written policies required: that the physician be notified of any pressure sore, even at stage I; that the licensed nurse who first discovers the "pressure area" obtain a treatment order from the physician, without waiting for the facility's skin integrity coordinator; that the order be transcribed onto the treatment records; that the licensed nurse or therapist document on the resident treatment sheets each time the treatment is completed; and that all treatment orders be documented on the treatment administrator record (TAR) for individual residents. P. Ex. 53, at 5, 7, 14, 16, 20, 25. However, Petitioner disclaims any staff obligation to follow its own written policies. The protocols are merely "suggested care policies," that are "provided as a resource tool." P. Ex. 53, at 7. And, as the discussion above demonstrates, these "suggestions," in fact, were not followed. Instead, the facility implemented an entirely different, apparently unwritten, and ineffective approach, which minimized physician involvement, and, in some cases, excluded the physician entirely from treatment decisions. He was not consulted or even notified of changes in a resident's condition. New treatment was implemented without his knowledge or consent. Instead, under the facility's unwritten policies, an LPN with questionable training in wound care diagnosed conditions and wrote the treatment orders.

Moreover, to implement a policy requires more than maintaining a paper file of documents without actually regulating staff actions. Sufficient examples of neglect can demonstrate that the facility has not implemented an anti-neglect policy. Barn Hill Care Center, DAB No. 1848, at 9-12 (2002); Emerald Oaks at 18. "Neglect" means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. 42 C.F.R. § 488.301. I have discussed at length specific instances in which pressure sores went untreated, were inadequately or improperly treated, and were treated without physician consultation or valid treatment orders. Resident #1's sores were observed one week before the physician was notified and treatment started; Resident #4 developed wounds on his hip and right heel that were treated without physician notification or order. In the case of his right heel, the treatment was highly questionable. Notwithstanding his extreme vulnerability, staff did not provide him with the heel protectors and protective cushions that had been ordered. Resident #5's open sores went untreated for two days. Resident C was left lying in waste; her open wounds were exposed to feces, and, in fact, she developed serious infections, one specifically related to fecal contamination. Residents #22 and #27 developed pressure sores that went untreated. These are all examples of neglect.

In addition, each of the cited grooming deficiencies constitutes an example of neglect. The fingernails of four residents were not properly trimmed or cleaned. In at least two instances, the residents used their fingers to feed themselves. In one instance, because his hands were contracted, the untrimmed nails dug into the palm of the resident's hand.

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

II. CMS's determination that the facility's deficiencies posed immediate jeopardy to its residents was not clearly erroneous.

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

The facility failure to keep all of its residents clean and dry, notably Resident C, created an immediate jeopardy situation. Further, each example in which the facility delayed treatment of an identified pressure sore presented the likelihood of serious injury or harm. Besides the obvious discomfort to the affected resident, pressure sores can become portals for infection. Tr. 215, 251. The risk is particularly acute in instances, such as these, where the resident is incontinent and the skin breaks down on the buttocks, sacrum, or hips. Dr. Holtz explained that

persistent, prolonged exposure to urine and feces, by open abraded skin, imperceptible skin sores, and skin lesions (pressure sores) is a very strong risk factor for the development of infections. These can be life threatening in a susceptible individual.

CMS Ex. 15, at 1, ¶ 4 (Holtz Decl.). This opinion was echoed by Surveyor Chuven. Exposure to urine generally causes excoriation of broken skin and inhibits healing. Exposure to feces creates a likelihood of infection and also contributes to excoriation and inhibits healing. CMS Ex. 13, at 3, ¶ 12. See also P. Ex. 53, at 15, 19 (Protocols for treatment if pressure ulcer is in a location, including the buttocks, where it is exposed to urine and feces). As Dr. Holtz explained, the location of the wound makes it imperative that the wound be carefully dressed so that it not become contaminated with feces. Feces typically contain multiple bacterial species, many of which cause disease. Some can cause life-threatening infections if introduced into the body through open wounds or sores. CMS Ex. 15, at 1-2, ¶ 5 (Holtz Decl.). Resident C offers an unfortunate but unmistakable example of the harm that can result. She developed open wounds. They were exposed to feces and urine, and she developed life-threatening infections.

Inasmuch as the facility's deficiencies caused actual harm and had the potential to cause even more serious harm, I do not consider erroneous CMS's finding of immediate jeopardy.

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

Citing the flimsiest of evidence, Petitioner claims that its deficiencies were resolved by November 18, 2000, so that its penalty should end as of that date. However, I could not find that the facility achieved substantial compliance as of that date even if I accepted Petitioner's largely unsupported claim that the facility monitors, who subsequently visited the facility, found that appropriate care was being provided for "virtually every resident whose care was cited as deficient" during the survey. P. Brief at 87-88.

The Board has repeatedly explained that under the regulatory scheme, any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility that need to be corrected. Barn Hill at 12-18; Lake City at 14. Since I found that the deficiencies cited have the potential for more than minimal harm, I must also find that the facility was out of compliance "from the date of the completion of the survey in which [these] deficiencies were cited until the date of the resurvey in which substantial compliance was established." Lake City at 14-15. Substantial compliance means not only that the specific cited instances of substandard care were corrected, and that no other instances have occurred, but also that the facility has implemented a plan of correction designed to assure that no such incidents occur in the future. (16) No findings that the facility violated the standard of care between these dates are required in order to find the facility out of substantial compliance, nor can evidence of other incidents in which the facility met the standard of care change the fact that it was out of substantial compliance. Barn Hill; Lake City at 15. See also Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002) (The burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that deficiencies continued to exist after they were discovered.); Asbury Center at Johnson City, DAB No. 1815, at 19-20 (2002) ("[A] facility's return to substantial compliance must usually be established through a resurvey, and in a situation involving inadequate supervision, requiring such a resurvey seems wise."); Cross Creek Care Center, DAB No. 1665 (1998).

IV. The amount of the CMP is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount CMS imposed is reasonable, applying the factors listed in 42 C.F.R. § 488.438(f). Emerald Oaks at 10; Care Plex of Silver Spring, DAB No. 1683, at 16-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). The facility must timely raise its claim that a particular factor makes a CMP unreasonable before any question arises as to CMS's responsibility for producing evidence as to that factor. Community Nursing Home, DAB No. 1807, at 22 (2002).

Before setting out any claim that a particular factor makes the amount of the CMP unreasonable, Petitioner criticizes the appellate decision in Emerald Oaks and other cases, arguing that CMS should have to explain first how it applied the § 488.438(f) factors in arriving at the amount of the CMP. The Board has firmly and repeatedly rejected that notion. Barn Hill at 21-22; Emerald Oaks at 11; see also Capitol Hill Community Rehabilitation; South Valley Health Care Center, DAB No. 1691 (1999).

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

Emerald Oaks at 13.

So, in reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Community Nursing Home at 22, et seq. (2002); CarePlex, at 8.

For the days it determined the facility's deficiencies posed immediate jeopardy to resident health and safety, CMS imposed a penalty of $5,000 per day, which is at the lower end of the mandatory range ($3,050 to $10,000) for immediate jeopardy situations. For the remaining days of noncompliance, CMS imposed a penalty of $750 per day, which is also at the lower end of the mandatory range ($50 to $3,000 per day).

With respect to the § 488.438(f) factors, Petitioner denies that it was noncompliant, and claims, citing CMS Ex. 1, that it had a good compliance history, with "no history of serious or persistent deficiencies in any pertinent category." Petitioner describes its survey history as "unremarkable, with only a few minor deficiencies and almost none in any clinical area." P. Brief at 86. CMS disputes Petitioner's claim, and, based on the same exhibit, argues that the facility had a poor compliance history.

CMS Ex. 1 includes the facility's history profile (Oscar Report) and the results of a complaint investigation visit conducted July 20-21, 1999. The Oscar Report shows that the facility was not in substantial compliance with program requirements during the two surveys immediately preceding the November 2000 complaint investigation at issue here. During the December 1998 annual survey, the surveyors found isolated deficiencies with the potential for more than minimal harm under Tag F309 (quality of care - facility must provide necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being), Tag F312 (activities of daily living provided for dependent residents) and Tag F327 (facility provides sufficient fluid intake). They found a pattern of deficiencies with the potential for more than minimal harm under Tag F323 (the facility is free of accident hazards).

During the February 2000 annual survey, the surveyors cited isolated deficiencies that posed the potential for more than minimal harm under Tag F316 (appropriate treatment for incontinent residents). CMS Ex. 1, at 9.

Responding to complaints, a state survey team visited the facility in July 1999 to conduct a complaint investigation. The investigator found deficiencies under Tags F312, F314 (quality of care - pressure sores), and F353 (nursing services - sufficient staff). Anonymous callers had complained, inter alia, that the facility had inadequate staff and that residents were neglected. The investigator reported that eight residents had not been provided services to maintain good personal hygiene, finding isolated instances of actual harm that was not immediate jeopardy under Tag F312. The investigator also found a pattern of deficiencies that caused actual harm but was not immediate jeopardy because of inadequate staffing (Tag F353), and because the residents were not adequately cared for and staff were not providing care and treatment to prevent and heal pressure sores (Tag F314). CMS Ex. 1, at 2.

I do not consider this a favorable compliance history. To the contrary, it shows that deficiencies had previously been cited for the facility's treatment of incontinent residents, for its hygiene services to dependent residents, and for its care in preventing and treating pressure sores. The facility had previously been cited for problems similar to those presented here, had been given opportunities to correct, but had not achieved any lasting correction. This is precisely the type of history that justifies an increased CMP.

Moreover, even without regard to the facility history, the seriousness of the deficiencies and the facility culpability here justify the imposition of penalties well above the minimum, and I am, therefore, not able to find CMS's determination unreasonable.

V. Petitioner's objections to procedures followed are without merit.

Petitioner has submitted lengthy arguments addressing issues other than the actual survey findings that resulted in the imposition of the CMP. Without losing sight of our purpose here - which is to decide whether the facility was in substantial compliance with program requirements and, if not, to assess whether the penalties imposed were reasonable - I now consider the Petitioner's complaints about the procedures followed in hearing this case.

Some of Petitioner's complaints have nothing to do with this particular case. Petitioner argues that an ALJ has no authority to find deficiencies that were not cited by the surveyors or by CMS. While the record here may suggest additional deficiencies, in reaching this decision, I rely solely on deficiencies cited by CMS, so Petitioner's arguments do not apply here. But see 42 C.F.R. 498.56 ("The ALJ may consider new issues even if CMS . . . has not made initial or reconsidered determinations on them, and even if they arose after the request for hearing was filed or after a prehearing conference.")

Petitioner also presents arguments as to the relative burdens of the parties under the Hillman rule, and makes a very belated complaint about the order in which the evidence was presented here. Hillman requires that CMS set forth a prima facie case that the facility was not in substantial compliance. Petitioner has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Meadow Wood Nursing Home, DAB No. 1841 (2002); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. HHS, No. 98-3789 (D.N.J. May 13, 1999); Cross Creek.

Review of the record in this case establishes that CMS easily met its initial burden of establishing a prima facie case. In its submissions, Petitioner set forth the findings of fact and conclusions of law with which it disagreed. In response, CMS articulated precisely the evidence that formed the basis of its determination. The Statement of Deficiencies sets forth the surveyor's specific findings (CMS Ex. 17) and, in her testimony, Surveyor Chuven confirmed that those were the surveyor findings. CMS Ex. 13. CMS also presented copies of facility records and other documents that supported CMS's assertions.

Petitioner nevertheless argues that the Board's ruling in Hillman has been misapplied "in two distinct regards." First, according to Petitioner,

this tribunal consistently commented throughout the hearing (and frequently cut off Petitioner's cross-examination of CMS's evidence on that basis) that she believes that any defects in CMS' allegations or evidence "don't matter" because once CMS makes an allegation of poor care, it always is a petitioner's burden to demonstrate compliance with the regulations.

(Emphasis in original) P. Brief at 6, citing Tr. 48, 59-60, 61, 114. Second, Petitioner claims that "[the Court] further believed that any defects in CMS's allegations were immaterial because she could review the evidence 'de novo' to determine whether Petitioner was in substantial compliance." P. Brief at 6-7, citing Tr. 43-46, 59-60, 108, 123, 157, 165.

Nowhere in the transcript did anyone suggest that CMS meets its prima facie burden simply by making an allegation, and I make no such ruling here. Indeed, review of the transcript citations demonstrates that no particular rulings were made, that Petitioner's cross-examination was not cut off (although occasionally some objections to inappropriate questions were sustained), and Petitioner apparently misunderstood the suggestion that it concentrate its efforts on the deficiencies pressed by CMS, rather than those removed as a result of the IDR process. At page 47 of the transcript, for example, Petitioner's counsel announces that he will ask about the deficiencies deleted at IDR. CMS immediately objects based on relevance. The ruling on the objection was as follows:

[S]ince surveyor observations are not immaterial to this and he wants to attack, you know, observations and judgment . . . I'm going to allow (Petitioner) to do that. I just don't want to spend a lot of time on it because it (i.e. that deficiencies were removed at IDR) is sort of a peripheral issue. And we don't want to lose sight of your real job here, which is to demonstrate your substantial compliance.

Tr. 48. At pages 59-60 of the transcript, still questioning the surveyor about the findings deleted at IDR, Petitioner's counsel posed this question:

[L]et's just say hypothetically, we've established that every single one of your allegations except one turns out not to be true, are you able to make a judgment whether that was the one that made you say immediate jeopardy or is it your testimony that it was everything put together in a pattern.

Tr. 59. CMS objected and the objection was rightfully sustained. As the Board ruled in Emerald Oaks, the ALJ resolves the issue as to whether a basis existed to support the imposition of the CMP "de novo in the sense that the determination is based on the evidence as it is developed before the ALJ and not on how CMS evaluated the evidence as it stood at whatever point CMS made its assessment." Emerald Oaks at 13. Moreover, the state surveyor was not even the decision-maker in this case. She was essentially a fact witness, who testified about her observations, and offered her professional judgment as to the significance of those observations. A question that asks her to speculate on what she might have done had she found a different situation is neither material not relevant.

At the close of the hearing Petitioner argued, for the first time, that the November 15, 2002 order (and presumably the December 17, 2002 amended order) violated Hillman because it required Petitioner to file the first set of pre-hearing submissions. (17) P. Brief at 11, et seq. This argument fails for two reasons. First, because it did not file a timely objection, Petitioner has waived any objection to the process. Petitioner did not object to the order when it was issued in November 2002, nor to the amended order, issued in December 2002. Petitioner received CMS's pre-hearing submissions more than two months prior to the in-person hearing, and did not object to them nor ask leave to supplement its own pre-hearing exchange. Although Petitioner complains that "the Court afforded neither party the right to supplement its exchanges," both the November and December orders specifically set forth a procedure by which the parties could do so:

A party may move to amend its pre-hearing exchange . . . . I will decide a motion to supplement a pre-hearing exchange based on considerations of good cause and absence of prejudice to the opposing party.

Ruling and Exchange Order at 2-3, ¶ 3 (November 15, 2002); Order Granting Extension and Establishing Amended Prehearing Deadlines, at 2, ¶ 3 (December 17, 2002).

Second, even if Petitioner had not waived its objections, its position fails on the merits. Petitioner confuses an evidentiary standard with procedure. Under the regulations, the ALJ has the authority to determine the order in which the evidence and the arguments of the parties are presented. 42 C.F.R. § 498.60; Beechwood Sanitarium at 17. Petitioner misreads VITAS HealthCare Corporation of California, DAB No. 1782 (2001). In that case, the ALJ took the testimony of some of Petitioner's witnesses before CMS had provided evidence sufficient to establish a prima facie case. When CMS ultimately rested its case, the ALJ, considering only CMS's evidence and witnesses, found that it had not sustained its initial prima facie burden. In sustaining the ALJ decision, the Board cited with approval "many common practices, such as allowing presentation of witnesses out of order and admitting exhibits prior to the in-person hearing," concluding that parties to the administrative process "routinely benefit from such flexibility." VITAS at 2. VITAS thus stands for the proposition that the order in which evidence is taken does not affect the parties' burdens, and the ALJ has broad discretion to determine that order.

The Board confirmed this reading in Beechwood. There, Petitioner faulted the ALJ for his declination to rule on the adequacy of CMS's case prior to demanding that Petitioner respond to CMS's claims, arguing that the ALJ actions were "unfair and impractical" and hampered Petitioner's efforts to forward its case "in the most effective and efficient manner possible." Beechwood at 16. Citing 42 C.F.R. §498.60, the Board ruled that "the regulation clearly provides that the ALJ has the discretion to set the process for presentation of the parties' arguments." The Board noted that, in affirming VITAS, it did not rule that the procedures used there were required, rather that the ALJ did not abuse her discretion by proceeding in that fashion. Beechwood at 17.

VI. Petitioner's request to add additional evidence is denied except with respect to ALJ Ex. 1.

Finally, Petitioner seeks to supplement the record with additional declarations from LPN Smith, RN Snow, and Dr. Hall. I admit the declaration from LPN Smith, but decline to admit the documents from the other witnesses. Consistent with the Board's ruling in Hillman, CMS submitted evidence in the form of declarations and documentary evidence that responded specifically to the issues raised by Petitioner. I reject Petitioner's claim that it was not afforded sufficient opportunity to reply to this evidence. As discussed above, both the November 15 and the December 17, 2002 orders provided a procedure by which Petitioner could have supplemented its pre-hearing submissions, but Petitioner declined to do so.

Even now, Petitioner offers no legitimate justification for submitting post-hearing rebuttal evidence. Aside from the circumstances surrounding ALJ Ex. 1, none of CMS's witnesses offered any new or surprising testimony. Their testimony closely reflected the information set forth in the statement of deficiencies. Counsel's explanation that he had not acted sooner to object because he "didn't review the government's testimony and see how much it matched up" to Petitioner's submissions does not justify reopening the record at this late date. Tr. 279; see Forest Glen, DAB No. 1887, at 16-17 (2003) (Petitioner's request to submit additional evidence denied where the ALJ's orders contain clear directions for when proposed exhibits and direct testimony were due, and Petitioner failed to raise a timely exception).

Moreover, Petitioner specifically declined to call these witnesses at the time of the hearing. RN Snow was at the hearing. When asked for a proffer of his rebuttal evidence, counsel replied, "The proffer would be Ms. Snow would testify that many of the observations that Ms. Chuven in particular had made or - -

Judge Hughes: Ms. Snow will testify?

Mr. Bianculli: Right.

Judge Hughes: She's here. Why doesn't she testify here and now?

Mr. Bianculli: Well if you want me to call her, I'll call her. Now, I don't know how you'll characterize - -

Judge Hughes: Why would we delay the hearing when the witness you want to call is here?

And later,

Judge Hughes: If you want to call Ms. Snow, you call Ms. Snow now. I'll give you the last word on that. You have a witness to call, you call that witness.

Tr. 247-248. Petitioner declined to call the witness.

Petitioner also declined the opportunity to call Dr. Hall. As with the other witnesses, Dr. Hall submitted his direct examination testimony in the form of a declaration. At the hearing, CMS indicated that it had no cross-examination questions for Dr. Hall. I indicated that I would not force Dr. Hall to appear if CMS had no questions "unless Mr. Bianculli has some compelling reason why I should." Tr. 220. Counsel thus had the opportunity to decide whether he wanted to bring Dr. Hall in, and to set forth reasons why he should be brought in. We went off the record to allow counsel to review Dr. Hall's testimony to determine if he needed to bring him in. Tr. 219-224.

Judge Hughes: What we can do is go off the record and give you a couple of minutes. Maybe you want to talk to your client and let us know whether or not he'll be coming in tomorrow.

Tr. 221.

Judge Hughes: But Ms. Benton is within her rights to object to his being allowed to come in to offer more direct questions since she had no cross.

Tr. 222.

Counsel: Well let me review Dr. Hall's testimony again in light of the colloquy here and just see of there is anything that needs to be added to it. I kind of doubt that there isn't (sic) but just one more look.

Tr. 224.

Counsel finally stated:

That's fine, Your Honor. I mean if counsel don't (sic) want him and you don't want him, then that's fine. I won't press the point.

Tr. 225. And later,

I do not anticipate at this point that there will be any rebuttal. If there is some I will obviously have to ask leave to put it on first thing in the morning.

Tr. 226.

The next morning counsel complained that his witnesses, who were fact witnesses, had not had the opportunity to appear so that I could assess their credibility. I assume that his claim was essentially limited to Dr. Hall inasmuch as RN Snow was present (and, in fact, had testified earlier). Tr. 232. He also argued that since he bore the burden of proof, he should have the "last opportunity to present evidence." However, he then did not produce Dr. Hall. He refused even to make the effort. Tr. 236

Thus, Petitioner had ample opportunity to present rebuttal witnesses (without even having made a showing that their testimony was true rebuttal), and explicitly declined to do so. I therefore decline to admit their declarations at this late date.

CONCLUSION

This is not a case for which the allocation of burdens is significant. Under any standard of review, the evidence here establishes that the facility was not in substantial compliance with program requirements during the period in question, and that for 11 days, from November 16 through 26, 2000, the facility's deficiencies posed immediate jeopardy to resident health and safety. I also find that the amount of the CMP imposed - $5,000 per day for 11 days and $750 per day for 30 days (total of $77,500) - is reasonable.

JUDGE
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Carolyn Cozad Hughes

Administrative Law Judge

FOOTNOTES
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1. In its brief, CMS incorrectly calculates the amount of the CMP as $72,500. CMS Brief at 2. Petitioner accurately calculates the amount as $77,500. P. Brief at 3.

2. Pressure sores (also referred to as pressure ulcers or decubitus ulcers) are classified into stages, based on the extent of the damage to skin and underlying tissue. At stage I the ulcer appears as a "defined area of persistent redness in lightly pigmented skin," or "may appear with persistent red, blue or purple hues" in darker skin. The color change may be accompanied by changes in skin temperature, tissue consistency, and/or sensation (pain, itching). Stage II is characterized by partial thickness skin loss, and presents as an abrasion, blister, or shallow crater. Stage III involves full thickness skin loss with damage or necrosis. It presents as a deep crater with or without undermining of adjacent tissue. By stage IV, the skin loss is full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone or supporting structures. Undermining and sinus tracts may also be associated with stage IV pressure ulcers. P. Ex. 53, at 3, 14, 16, 20, 25; CMS Ex. 13, at 8.

3. Petitioner complains about an error in the Statement of Deficiencies, not pointed out until the first day of the hearing. In error, references to Resident #1 and Resident #4 were interchanged at one place on the document (#1 was typed where #4 should have been and vice versa). P. Ex. 1, at 2; CMS Ex. 17, at 3. Because the deficiencies cited were very similar (e.g., sore on buttocks vs. sore on hip; sore on ® heel vs. sore on ® lateral foot), the error is not immediately obvious. I agree that CMS should have advised Petitioner and this tribunal of the error as soon as it noticed, and I am not wholly satisfied with its explanation for failing to do so. However, I disagree that Petitioner was harmed by the mistake. First, even with the error, the entry identifies sufficiently the residents in question and the purported deficiencies, putting Petitioner on notice that CMS had concluded that it had not provided these residents the care necessary to treat and prevent pressure sores, nor consulted the residents' physician about changes in condition. Second, even disregarding completely those particular entries, which fall under Tag F157 (Resident Rights), elsewhere, under the "Quality of Care" deficiencies (Tag F314), the document accurately details the surveyor findings. See, P Ex. 1, at 10; CMS Ex. 17, at 11. So, even if Petitioner could legitimately claim confusion as to the deficiencies cited under Tag F157, it could make no such claim for the deficiencies cited here, under Tag F314. Finally, Petitioner was served with Surveyor Chuven's written declaration, along with CMS's argument, by express mail, on February 27, 2003, nine weeks prior to the in-person hearing. See, e.g., CMS Ex. 13. Those documents include Surveyor Chuven's testimony and CMS's position with respect to this, and other, deficiencies. So, at the time of the in-person hearing, Petitioner had before it, in considerable detail, CMS's specific allegations of non-compliance.

4. The error is so blatant that it may simply have been an oversight or typographical error, except that, in context, Petitioner plainly meant to argue that the observation was dated November 9. Although in its reply brief (P. Reply), Petitioner appears to concede the November 2 date, it does not explain its earlier error.

5. Moreover, the other, less likely, possibility - that her November 2 skin breakdowns resolved without treatment, but, almost immediately thereafter, she developed new stage II pressure ulcers on both buttocks - does not help the facility. It still was not furnishing any discernable treatment to prevent the development of new sores.

6. Petitioner submits with its post-hearing brief, as a "supplemental exhibit," which I do not accept, a treatment order dated June 5, 2000, to "clean left heel with dermal wound cleanser and apply Alldress and Normigel every day," and asserts that this order was in effect through October and November. Petitioner does not provide order sheets for the intervening months, and, in fact, the July 21 order cited above appears to have discontinued the June order. P. Ex. 31, at 2. The record contains no evidence of a physician treatment order prior to September 6, 2000; in fact, the order that appears on the October and November order sheets was issued on September 6, 2000. P. Ex. 31, at 4. Thus, even if admitted, the document would not establish an ongoing physician order. Moreover, no deficiencies are cited with respect to the absence of a physician order addressing the prevention and treatment of Resident #4's left heel wound.

7. Many of the facility records are inconsistent and therefore unreliable. Here, for example, even though Resident #4 had a significant left heel wound with an odorous discharge, a September 20, 2000 progress note, signed by Barbara Daniel LPN, does not even mention the left heel wound. The September note is almost the same, verbatim, as the August 20, 2000 progress note, which is also signed by Barbara Daniel LPN. Compare P. Ex. 28, at 6 with P. Ex. 28, at 4. Nurses Progress Notes dated October 10, 2000, do not even mention the pressure sore on Resident #4's left heel, but describe his feet as "normal." P Ex. 28, at 8. In fact, at that point, the left heel wound measured 4 x 3.8 cm, and had foul smelling drainage. P. Ex. 29, at 1.

8. A skin assessment dated October 11, 2000, suggests that, in fact, the first signs of breakdown were noticed earlier. The document checks discolorations on the back area, erythema on buttocks/hip area, erythema on ankles, and decubitus and erythema on the left heel. P. Ex. 28, at 13.

9. I note that the nurse receiving these orders is an RN and not LPN Smith.

10. In order to avoid fatal consequences caused by deterioration, p hysicians recommended left leg amputation, which the resident and his family resisted, resulting in the hospice referral. While under hospice care, the resident apparently agreed to the procedure.

11. Nor would Petitioner benefit by establishing that these were vascular rather than pressure ulcers, since the appropriate response to the development of a vascular ulcer, which is at least as involved as the response to the development of pressure ulcers, was not being followed. See P. Ex. 53, at 32. Petitioner's own protocols provide for early physician notification to determine the etiology of a vascular ulcer and to develop an appropriate treatment based on that etiology. Consultation with the ET (enterostomal therapy) nurse "may be appropriate," but the instructions plainly require physician involvement, as well as the involvement of the skin care team. P. Ex. 53, at 32.

12. I discuss below the reasons I admit the Smith declaration but decline to admit the Snow supplemental declaration. I note that with respect to LPN Smith's alteration of a treatment record, RN Snow has no first-hand knowledge and simply reiterates her conversation with LPN Smith.

13. The facility order sheets raise additional questions about Nurse Parrish's claim that he observed no skin breakdowns when he examined Resident #22 on November 18. A November 19 entry on the order sheet says "Sacral wound: Clean [with] dermal cleanser. Apply transparent dressing. [Change every] 5-7 days and as needed. P. Ex. 110, at 4. The sheet indicates the order was dated November 19, followed on November 19, and discontinued on November 19. Another order, apparently followed on November 21 and 22, but discontinued November 23, says: "Sacral wound: clean [with] NS. Apply mitroflex film. Change every 5-7 days and as needed. May secure with skin prep and Kerfix or Hyperfix if needed." P. Ex. 110, at 4.

14. Inasmuch as she identified the sore on Resident #27's buttock as "pressure ulcer, 2" it seems that Nurse Chastain recognized that a pressure ulcer may develop on the buttocks.

15. Petitioner makes much of the fact that some of the cited deficiencies, including those involving Resident #16, were removed at informal dispute resolution (IDR), asserting that removal of some deficiencies undermines all of the survey findings. The appropriateness of the deleted deficiencies is not an issue for this tribunal. Nevertheless, to the extent that Petitioner claims that the IDR result damages surveyor credibility, I note that the practice described by RN Parrish is wholly consistent with Surveyor Chuven's findings involving Resident #16. Surveyor Chuven, who was not part of the IDR process, testified that she called the physician's office at 3:50 p.m. His nurse said that he was at a funeral that day and had not been in the office. Yet, the facility had an order written at 2:48 p.m. When Surveyor Chuven called the physician office at 4:05 p.m., the nurse told her that someone from the facility called between 2:30 and 3:00 p.m., asking about putting Mefilm on the wound. No one suggested that the physician had been notified, and Surveyor Chuven concluded that he could not have been notified. RN Parrish's description of the facility/physician practice seems to confirm her conclusion. Tr. 56-57; P. Ex. 17, at 4.

16. I note that the facility did not even submit its plan of correction until December 1, and the plan only claimed correction as of November 27, 2000. CMS Ex. 17.

17. Petitioner refers to the procedures followed in this case as "experimental" and "ad hoc." In fact, two judges have been using some form of this initial order for the last year and a half. Ordinarily, the order requires CMS to file the first submissions. However, in some cases where a petitioner fails to set forth in its hearing request the findings of fact and conclusions of law with which it disagrees, my practice has been to require the petitioner to make the first submissions.

CASE | DECISION | JUDGE | FOOTNOTES