SUBJECT:

Britthaven of Havelock,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Britthaven of Havelock, is a nursing facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS's) determination that, from August 10, 2002 through September 5, 2002, it was not in substantial compliance with program participation requirements and that its noncompliance constituted immediate jeopardy. As a remedy, CMS imposed a $5000 per day civil money penalty (CMP). For the reasons discussed below, I affirm CMS's determination that Petitioner was not in substantial compliance with program participation requirements and further affirm the CMP imposed, but for three days less than the period for which CMS cited the facility. As I explain below, I find and conclude that the period of Petitioner's noncompliance ended on September 2, 2002.

I. Background

The North Carolina State Survey Agency (State Agency) completed a complaint survey at Petitioner's facility on September 5, 2002. The State Agency determined that Petitioner was out of compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs, specifically citing noncompliance with 42 C.F.R. � 483.10(b)(11) and finding that the noncompliance constituted immediate jeopardy (Tag F 157 on the Statement of Deficiencies dated September 5, 2002). By letter dated October 2, 2002 (2002 notice letter), CMS informed Petitioner that, based on the State Agency's findings, it was imposing as a remedy a per instance CMP of $10,000. Petitioner requested a hearing and the case was docketed and assigned to me for hearing and decision as Docket No. C-03-149.

By letter dated September 10, 2003 (2003 notice letter), CMS informed Petitioner that it was revising the statement of deficiencies. CMS informed Petitioner specifically that it was changing the CMP from the $10,000 per instance CMP and instead imposing a $5000 per day CMP from August 10, 2002 through September 5, 2002. CMS further informed Petitioner that the revised CMP was based not just on the noncompliance cited under Tag F 157, but on noncompliance with 42 C.F.R. � 483.13(c) (Tag F 224 on the revised statement of deficiencies), ⁽¹⁾ which CMS found to constitute immediate jeopardy. Petitioner filed a motion to strike CMS's revised determination. To preserve its rights, Petitioner also filed a hearing request to contest the revised determination, which was docketed by my office as Docket No. C-04-53.

In my "Interim Order and Procedures and Schedule for Hearing" dated March 8, 2004, I found that the facts at issue in both Docket Nos. C-03-149 and C-04-53 are the same and that the addition of Tag F 224 to the revised determination does not alter the factual identity of the two cases. I found further that the regulations permit CMS to revise its determinations within 12 months of the initial determination. I thus denied Petitioner's motion to strike. I then consolidated the two cases under Docket No. C-04-53.

I held a hearing in the case in Raleigh, North Carolina, from August 23 through 27, 2004. Testifying at the hearing for CMS were: Steven A. Stiens, M.D.; Jeffery Anderson, M.D.; Linda Griffin, R.N.; John D. Butts, M.D.; Jalenda Flewwellin, EMT; and Steven Coffey, paramedic. Testifying for Petitioner were: John Rubino, M.D.; Ruby Kessenger; Charlene Small, R.N.; and Marquita Mihaliak, Administrator. I struck the testimony of Tanisha Magwood, for reasons discussed below. I admitted CMS exhibits (CMS Exs.) 1 through 6, 8 through 56, 66, and 68 (Transcript (Tr.) 1317-18) and Petitioner's exhibits (P. Exs.) 1 through 24, 26, 27, 29, 31, 32, 34, 35, and 37 through 43 (Tr. 1253-55, 1318-19). The parties filed posthearing briefs (CMS and P. Brs.); posthearing response briefs (CMS and P. R. Brs.); and prehearing briefs (CMS and P. Prehearing Brs.).

Before I begin my substantive discussion of the case, I note two rulings I made during the hearing. Any hearing presents the potential for rulings that affect the nature and content of the evidentiary record on which a decision is based. This decision, and the findings and conclusions that support it, are based on a record affected by two significant evidentiary rulings, one adverse to Petitioner, and one adverse to CMS. The particular nature of those two rulings deserves some brief mention here.

The ruling adverse to Petitioner became known during the hearing as the "Magwood ruling," and it resulted in the striking of the entire testimony of Petitioner's witness, Tanisha Magwood, and her written statement in the form of P. Ex. 33, and in the ancillary ruling that certain other persons identified as witnesses by Petitioner would not be permitted to testify. The ruling adverse to CMS will be described here as the "Norelli ruling," and it denied the admission of proffered CMS Ex. 67, a written statement in the form of a printed e-mail attributed by CMS to Anne Norelli, whom CMS had subpoenaed but did not call as one of its witnesses.

The "Magwood ruling" arose in the context of an incomplete exchange of Tanisha Magwood's prior written declarations. Ms. Magwood had been identified by Petitioner as one of its witnesses, and was called to testify as Petitioner's first witness in its case-in-chief. As an accommodation to her other responsibilities, and with CMS's agreement, she appeared out-of-order during CMS's case-in-chief. Tr. 413-503. One of her written statements had been admitted as P. Ex. 33. Tr. 42-43.

CMS was conducting its cross-examination of Ms. Magwood when it became apparent that Petitioner had failed to exchange one of the two written statements it had taken from Ms. Magwood. Tr. 486. At no point in the prehearing exchanges was the existence of this un-exchanged statement disclosed or acknowledged by either side; Petitioner represented that the specific written statement had been the subject of a protective order obtained in state court and was therefore not subject to the exchange orders governing the development of this case. Tr. 487. Petitioner asserted that CMS had known of the document's existence for some time. Tr. 518-20. CMS represented that it had been unaware of its existence. Tr. 532-33.

The problem thus presented might have been avoided if Petitioner had chosen to raise the issue sooner, but, as matters stood, the situation was troubling: an important and possibly crucial witness for Petitioner had given two statements, and one of them had been deliberately withheld by Petitioner. The withholding of the Magwood statement deprived CMS of its use in cross-examining her, and made it impossible for me to review the statement to assess the materiality of its value for that purpose. Tr. 513-17. Petitioner's knowing, intentional failure to disclose the existence of the statement during the prehearing exchange process, when its disclosure would have allowed deliberate and timely consideration of Petitioner's right to withhold it, manipulated and interfered with the speedy, orderly, and fair conduct of the hearing. Tr. 488, 535-41, 723-29. That knowing and intentional interference invoked the authority set out in section 1128A(c)(4) of the Act, 42 U.S.C. � 1320a-7(c)(4).

My "Magwood ruling" sought to remedy the situation by offering Petitioner two alternatives: Petitioner might waive the effect of the protective order, produce the statement, and produce Ms. Magwood for further cross-examination on its contents, or it might invoke the protective order and withhold the statement, but suffer the striking of all Ms. Magwood's testimony and the related P. Ex. 33, and face the prospective exclusion of any other testimony from witnesses whose statements had not been fully exchanged, and who would therefore not be called, subject to the "Magwood ruling." Tr. 1253-55. Petitioner chose the latter alternative while preserving its objection to my ruling. Tr. 723-27. In conformity with the ruling on P. Ex. 33, P. Exs. 25, 28, and 30 were stricken as well, and remain in this record only as Petitioner's offer of proof. Tr. 1255.

The "Norelli ruling" arose when CMS attempted to manipulate the hearing process in a precisely complementary way and gain the admission of helpful written evidence without authentication and without exposing its source to cross-examination. Anne Norelli was named as a CMS witness and had been subject to subpoena for three weeks before the hearing. Tr. 889. She had in fact been present in Raleigh and available during the first two days of CMS's case-in-chief. Tr. 896. Nevertheless, CMS unilaterally released Ms. Norelli from the obligation of further attendance before it rested its case-in-chief, but, once she was gone, renewed its proffer of a printed version of an e-mail attributed to her as CMS Ex. 67. Tr. 889.

CMS had been aware since the very early stages of the hearing that the Norelli e-mail was subject to objection based on authenticity. Tr. 34-35. CMS knew that admission of proposed CMS Ex. 67 depended on authentication by its purported author who would then be subject to cross-examination on the contents of the e-mail, which included assertions damaging to Petitioner. Tr. 35-39. During three days in which repeated accommodations were extended to witnesses who needed special scheduling considerations, CMS did not call Ms. Norelli to testify, and did not attempt authentication of proposed CMS Ex. 67 through any other means. Admission of the Norelli e-mail was denied, but CMS was offered the option of calling Ms. Norelli as a rebuttal witness for purposes of authenticating the document. Tr. 893. CMS chose not to do so. Tr. 1310. The obvious effect of CMS's choice was to keep Ms. Norelli away from the witness stand and unavailable for cross-examination.

What remains disturbing about the "Norelli ruling" is this: it occurred after CMS had won the striking of the Magwood testimony, but had failed in its ill-conceived effort to re-admit the stricken P. Ex. 33 when proffered as CMS Ex. 70. Tr. 883. This disingenuous effort would have left one, but only one, of the Magwood written statements in the record unaccompanied and unilluminated by the witness's testimony or by the un-exchanged statement. It is not impossible to detect CMS's strategy in these gambits. That strategy was to proffer evidence helpful to its position and damaging to Petitioner without providing Petitioner or the trier of fact an opportunity or mechanism to test the reliability of that evidence. Such a strategy does no service to the hearing process. ⁽²⁾

II. Issues

1. Whether Petitioner was out of substantial compliance with participation requirements between August 10 and September 5, 2002.

2. Whether the CMP imposed by CMS against Petitioner is reasonable.

III. Statutory and Regulatory Background

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 and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

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, section 1819(h). CMS may impose a CMP for the number of days that a 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 deficiencies do not constitute immediate jeopardy (defined at 42 C.F.R. � 488.301 as a situation or situations in which a "provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident"), 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 $3000 per day. 42 C.F.R. � 488.438(a)(1)(ii). In situations where deficiencies constitute immediate jeopardy, CMS may impose a CMP of from $3050 to $10,000 per day. 42 C.F.R. � 488.438(a)(1)(i). When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1000 to $10,000. 42 C.F.R. � 488.438(a)(2).

IV. Burden of Proof

As an evidentiary matter, CMS must set forth a prima facie case that Petitioner is not in substantial compliance. Petitioner then 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. Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

V. Findings of Fact, Conclusions of Law, and 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. ⁽³⁾

1. CMS has made a prima facie case that, as of the survey ending on September 5, 2002, Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.10(b)(11) (Tag F 157 on the statement of deficiencies), which Petitioner has not rebutted.

This case involves a resident at Petitioner's facility, Resident 5, a 45-year-old quadriplegic, who was admitted to the facility on June 25, 2002, for short term respite care while his mother underwent knee surgery, and who died at the facility on September 2, 2002. ⁽⁴⁾ His treating physician at the facility, Donald Reece, M.D., noted that Resident 5 had bowel problems upon admission. CMS Ex. 4, at 1. It is this combination of Resident 5's quadriplegia and his bowel problems which drives the issues in this case and my ultimate decision.

During the hearing, CMS presented the testimony of Steven Stiens, M.D., an expert (and so acknowledged by Petitioner) in the care of individuals with spinal cord injury, with a specialty in neurogenic bowel, which refers to how a spinal cord injury can affect and change an individual's bowel function. Tr. 198; CMS Ex. 46; CMS Ex. 47, at 3. CMS provided a clinical practice guideline consumer guide on neurogenic bowel and a clinical practice guideline entitled "Neurogenic Bowel Management in Adults with Spinal Cord Injury" to help explain the condition. CMS Exs. 47, 48; see also CMS Exs. 49-55. I rely on both Dr. Steins' testimony and these exhibits in my discussion below.

Dr. Steins testified that his review of Resident 5's records showed that Resident 5's most important diagnosis was C5/6 Asia A tetraplegia (commonly referred to as quadriplegia). Dr. Stiens stated that all four of Resident 5's limbs were affected, but that he had the ability to flex at the elbows and move at least one wrist. Resident 5's other diagnosis included a cervical spine fusion, a history of hypertension, osteopenia, urolithiasis, cholecystitis, gall bladder removal, a previous partial gastrectomy and pyloroplasty. Tr. 277-78. Dr. Steins discussed Resident 5's impairments due to his quadriplegia. These included impairments in: upper motor neuron neurogenic bladder (for which he was fitted with a suprapubic catheter); upper motor neuron neurogenic bowel; neurogenic skin; the risk of autonomic dysreflexia ⁽⁵⁾; contractures; problems in psychologic adaptation; challenge of adapting to the nursing home; and spiritual access. Tr. 278-80; P. Ex. 6A, 6, 11. The impairment at issue here is Resident 5's upper motor neuron neurogenic bowel, which, as noted above, refers to how a spinal cord injury can affect and change bowel function. CMS Ex. 47, at 3.

Preliminarily, to understand the issues involved here, it is necessary to consider the digestive process, both in individuals with and without spinal cord injury, and with regard to Resident 5's specific condition. An individual's digestive system (also called the gastrointestinal tract) consists of the mouth, esophagus, stomach and small (also referred to as the small bowel) and large intestine, both of which make up the bowel. The colon is about five feet long and forms a question mark shape in the abdomen. Tr. 202-04, 207; CMS Ex. 47, at 7. To understand how an individual with neurogenic bowel compares to an individual without, the first step is understanding the digestive process. To wit:

The digestive process breaks down what [individuals] eat and drink into nutrients [the] body uses and waste that [the body] eliminate[s]. A wave-like action called peristalsis propels food through [the] GI tract. The undigested food, waste [the] body doesn't use, moves into the colon from [the] small intestine. The colon takes the moisture out of the waste and stores it. The waste follows the question-mark shaped pathway of the colon: up the ascending colon, across the transverse colon, down the descending colon through the sigmoid colon, and into the rectum on its way out of the body . . .

CMS Ex. 47, at 8.

After a spinal cord injury, the nervous system doesn't control bowel function as it did before the injury. Instead, a condition termed "neurogenic bowel,"

. . . affects the body's process for storing and eliminating solid wastes from food. After, SCI [spinal cord injury], the nervous system can't control bowel functions the way it did before. For most people, the digestive process is controlled from the brain by reflex and voluntary action. SCI interferes with that process by blocking messages from parts of the digestive system to and from the brain through the spinal cord. How it interferes depends on where along the spinal cord the injury is. Here's what normally happens. The colon stores stool until it's propelled out as a bowel movement. When the stool is pushed into the rectum, it triggers a reflex action. This action contracts the anal sphincter, keeping it closed so that stool doesn't slip out. Without SCI people can feel stool in the rectum and voluntarily contract the anal sphincter to hold in the stool . . . SCI can keep [an individual] from feeling stool . . . [it] can also affect peristalsis.

CMS Ex. 47, at 8-9.

There are two patterns of neurogenic bowel after spinal cord injury, depending on which part of the spinal cord is injured, reflexic or areflexic bowel. Resident 5's injury occurred in the neck . . . . Reflexic bowel

. . . usually results from SCI at the cervical (neck) or thoracic (chest) level. This type of SCI interrupts messages between the colon and the brain that are relayed by the spinal cord. Below the injury, the spinal cord still coordinates bowel reflexes. This means that although [an individual doesn't] feel the need to have a bowel movement, [the individual] still [has] reflex peristalsis. Stool buildup in the rectum can trigger a reflex bowel movement without warning. Between bowel movements, [the] anal sphincter will remain tight, and [the] colon will respond to digital rectal stimulation ⁽⁶⁾ and stimulant medications with reflex peristalsis that pushes the stool out.

CMS Ex. 47, at 9.

Dr. Stiens testified that an effective bowel program is necessary for individuals with spinal cord injury and that there are four components of that plan. Tr. 294-310. Individuals with spinal cord injury need to ensure that they have: 1) a dietary and liquids component to ensure soft, easy to pass stool and to pay attention to how food and drink affects bowel movement (CMS Ex. 47, at 23-27); 2) a medication component, including fiber for softer stool and osmotics; stimulant medication to produce more colonic peristalsis; triggering medications introduced into the rectum to trigger a bowel movement and enemas; 3) an activity component; and 4) a bowel care component, the assisted elimination of stool.

Prior to his admission to Petitioner's facility, and as a result of his quadriplegia, Resident 5 had a history of bowel problems, as outlined by Petitioner in its brief (P. Br. 10-11) by extrapolating from the notes of Resident 5's physiatrist, Christopher Delaney, M.D. Dr. Delaney's records (found at P. Ex. 14) show that Petitioner was following a bowel care program: in October, 1999, Resident 5 consulted Dr. Delaney for diarrhea, an "intermittent problem," and Dr. Delaney anticipated starting medication to stabilize his bowel functions if he did not respond to increased fiber; in September, 2000, for bowel incontinence "likely related to constipation or perhaps a partial impaction," with Dr. Delaney instituting a treatment plan; the next month, October, 2000, after an x-ray showed no obstruction or impaction, Dr. Delaney had an extended conversation with Resident 5 and his mother regarding his bowel care needs and problems; in February, 2001, Resident 5 consulted Dr. Delaney about his concern regarding intermittent bowel incontinence and they discussed his treatment regimen of high dose Metamucil, lots of fluid, and Dulcolax suppositories. Dr. Delaney added Imodium to the regimen, noting that it is a common technique for spinal cord patients to deliberately constipate themselves and do a full evacuation on schedule, which Dr. Delaney recommended take place every third or fourth day; in January, 2002, Resident 5 told Dr. Delaney that he had had a "very significant improvement in his bowel incontinence" since his last visit (only three accidents) but that he was having difficulty evacuating. Dr. Delaney noted that Resident 5 was taking Lomotil, and, rather than increase suppository frequency or intensity, Dr. Delaney added Senokot to Resident 5's treatment regimen. P. Ex. 14, at 9, 15, 16, 17, 18.

Resident 5 entered Petitioner's facility on June 25, 2002 (he had twice previously resided there for respite care). His FL-2 form, which was completed by his attending physician, Richard Bloomfield, M.D., on June 24, 2002, noted as his admitting diagnoses quadriplegia and suprapubic catheter and listed Dulcolax and Lomotil as his bowel medications. P. Ex. 11, at 9. He was then transferred to Dr. Reece's care at the facility (and was thereafter treated at the facility by Dr. Reece, and outside the facility by his physiatrist, Dr. Delaney, with regard to his bowel difficulties). As noted above, Dr. Reece recognized that Petitioner had bowel problems associated with his quadriplegia, noting that on admission Resident 5 was being treated with "Dulcolax alternating with Lomotil, apparently has quite a bit of bowel problems." P. Ex. 11, at 11. On June 29, 2002, Dr. Reece ordered that Resident 5 receive one dose of Lomotil in the a.m. and one in the p.m. on the first day of his cycle; on the second day one dose of Lomotil in the a.m.; on the third day Resident 5 was to receive one dose of Senekot in the a.m. and a Dulcolax suppository in the p.m. Every day Resident 5 was to receive Metamucil in the a.m. and p.m. CMS Ex. 15, at 9. ⁽⁷⁾ This schedule was instituted to keep Resident 5 on an evacuation schedule, constipating him for two days and then using a laxative to assist evacuation, in the hope of minimizing accidents. ⁽⁸⁾

I note that on or about July 12, 2002, Petitioner formulated a plan of care for Resident 5. While the care plan listed as problem areas physical mobility, suprapubic catheter, psychotropic medicines for anxiety, the risk of contractures and skin breakdown, the risk of depression, and that Resident 5 was over his ideal body weight, it did not mention his bowel problems. CMS Ex. 36. There is also no evidence of record that Petitioner ever amended Resident 5's care plan to address his unique bowel-care needs. P. Ex. 11, at 36-38. This is in spite of the fact that Dr. Reece noted on July 24, 2002, that Resident 5's "[g]reatest complaint has to deal with bowels. See's [sic] Dr. Delaney on a regular basis. Has a rather complicated bowel regimen outlined. Has appt again next month." P. Ex. 11, at 12. Dr. Delaney also noted that he "[c]hanged bowel regimen to [Resident 5's] specifications alternating Lomotil etc." Id.

As charted by CMS from Resident 5's bowel movement records, Resident 5's bowel movement records indicate that during the month of August 2002, and until his death on September 2, 2002, he had the following bowel movements (he was to receive a Dulcolax suppository each evening when not taking the Lomotil, the third day of a three day cycle (CMS Ex. 16, at 9)):

8/1	one planned bowel movement
8/2	two bowel movements, both unplanned "accidents"
8/3	two unplanned bowel movements
8/4	three bowel movements, at least one unplanned
8/5	two bowel movements, both unplanned
8/6	no bowel movements, none planned
8/7	Dulcolax suppository administered, but no bowel movement
8/8	one bowel movement, unplanned
8/9	one bowel movement, unplanned

CMS Br. at 6; CMS Ex. 14, at 3; CMS Ex. 16, at 9.

On August 9, 2002, Resident 5 saw Dr. Delaney, presenting "once again with a complaint of bowel problems." P. Ex. 14, at 19. Dr. Delaney's progress note stated "Sounds like pt. is not fully evacuating. ? High impaction. Will get x ray, try Dulcolax pills, but pt. may need full GoLytely bowel prep." CMS Ex. 4, at 4. The x-ray was done on August 9, with a report transcribed on August 10. The report indicated that "[t]here is a large amount of fecal material throughout the colon with air filled and dilated small bowel loops proximally. This most likely represents fecal impaction and some degree of small bowel obstruction." CMS Ex. 6, at 1. Dr. Delaney also recommended during the visit that Resident 5 discontinue the Metamucil and Lomotil. ⁽⁹⁾ Dr. Delaney was concerned that Resident 5 might be developing a cathartic bowel syndrome. However, these medications were not discontinued. P. Ex. 14, at 19. Instead, on the same date, August 9, 2002, Dr. Reece ordered Senekot discontinued and Dulcolax tabs given every day as needed if Resident 5 did not have a bowel movement. CMS Ex. 15, at 11; P. Ex. 11, at 30.

Between August 10 and September 2, 2002, there were 15 days where Resident 5 did not have a bowel movement. CMS Ex. 14, at 3. Petitioner's staff administered only four Dulcolax tabs to Resident 5 (CMS Ex. 16, at 11); Petitioner's staff administered 21 doses of Lomotil, 11 doses of Dulcolax suppositories, and 41 doses of Metamucil during that same period. CMS Ex. 16, at 9-12; CMS Br. at 6. On August 12, 2002, and again on August 19, 2002, Petitioner apparently faxed Dr. Delaney's office that Resident 5 was concerned that he was not "cleaned out." P. Ex. 37, at 42. However, there is no documentation that Dr. Delaney received or responded to this fax.

Specifically, Resident 5's bowel movement records reflect that:

8/10	Resident 5 was given a Dulcolax suppository, without a bowel movement
8/11	No bowel movement
8/12	No bowel movement
8/13	One bowel movement, but no record that a Dulcolax suppository given
8/14	One unplanned bowel movement
8/15	No bowel movement
8/16	No bowel movement, no record of a Dulcolax suppository
8/17	One unplanned bowel movement
8/18	No bowel movement
8/19	One planned bowel movement
8/20	One unplanned bowel movement
8/21	No bowel movement
8/22	Dulcolax suppository given, no bowel movement
8/23	Two unplanned bowel movements
8/24	No bowel movement
8/25	Dulcolax suppository given, no bowel movement
8/26	No bowel movement
8/27	No bowel movement
8/28	No bowel movement, no record he received a Dulcolax suppository

CMS Br. at 7-8; CMS Ex. 14, at 3; CMS Ex. 16, at 9. As of August 28, 2002, Resident 5 had gone five days without a bowel movement and had had no response to the Dulcolax suppository given on August 25 (which should have produced a bowel movement within an hour). CMS Ex. 43, at 2, 3, 6, 11, 13. On August 28, 2002, Dr. Reece examined Resident 5 at the facility. Dr. Reece found Resident 5 to be "medically stable." P. Ex. 11, at 12. However, Dr. Reece ordered a "milk & molasses enema x 2 at 8 pm" "If no results give Miralax 17 gm po Daily prn constipation" "If no results in 2 days give GoLytely prep." CMS Ex. 15, at 2; P. Ex. 11, at 30. The meal intake/BM records for August 29 and 30 indicate one bowel movement each day, but no bowel movement for August 31 or September 1. CMS Ex. 14, at 3, 4.

There are only four pages of nurse's notes detailing Resident 5's admission from June 25 through his death on September 2, 2002. They reflect the following observations: ⁽¹⁰⁾

P. Ex. 11, at 68-71.

Dr. Reece noted that "received a fax 12:11 in the morning from the night nurse, been having no results with bowel, been vomiting since 00:15 dark brown emesis. Abdomen reported as distended and hard. Pt. Trembling and sweaty. Did not receive the fax until after telephone call at approximately 7:40 in the morning when the patient suddenly collapsed, essentially no blood pressure, was unresponsive, CPR instituted, gurgling respirations. At 7:59, efforts were stopped after telecon by EMT's to Craven Emergency Room discussing with ER doctor in a telephone call to myself. Went back and reviewed last note from Dr. Delaney which talked about severe constipation, probable high impaction after an evaluation of the KUB. Pt. had drank Golyte 8/31 and 9/1, had no results as of 9/2. But I don't believe the bowel was the cause of such acute vascular collapse, unless there was a vascular episode of some kind within it." CMS Ex. 4, at 5.

The Medical Examiner indicated that Resident 5's cause of death was cardiorespiratory arrest due to treatment for constipation. CMS Ex. 13, at 1. ⁽¹¹⁾

The regulation at 42 C.F.R. � 483.10 is titled "Resident rights." Subsection 42 C.F.R. � 483.10(b)(11) is titled "notification of changes" and provides, among other things, that a facility must immediately consult with a resident's physician when there is a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications)."

As discussed by the Departmental Appeals Board (Board) in the case of Park Manor Nursing Home, DAB No. 1926 (2004), at 8,

[t]he preamble to the final rule implementing this provision responded to a request that CMS define the term "significant change." The preamble explained that the term would be defined as a "deterioration in health, mental, or psychosocial status in either life-threatening conditions (for example, heart attack, stroke) or clinical complications (for example, development of a stage II pressure sore, onset or recurrent periods of delirium)." 56 Fed. Reg. 48826, 48833 (Sept. 26, 1991) (emphasis added). [footnote omitted].

The preamble also stated:

We recognize that judgment must be used in determining whether a change in the residents's condition is significant enough to warrant notification, and accept the comment that only those injuries which have the potential for needing physician intervention must be reported to the physician.

Id. (emphasis added).

The statement of deficiencies which underlies Docket No. C-04-053 asserts that the participation requirement at Tag F 157 was not met because Petitioner failed to notify Resident 5's physician that: 1) Resident 5's bowel movements decreased in the month of August 2002; 2) failed to notify the physician to discuss whether it was appropriate to administer medication in light of an August 9, 2002 physician progress note that stated "questionably high impaction, will get x-ray"; 3) failed to notify the physician that Resident 5 refused two different bowel medications in a three step treatment regimen; 4) failed to notify the physician both that Resident 5 did not respond to a GoLytely prep administered on September 1, 2002, and that Resident 5 developed nausea, vomiting and a hard distended abdomen, and was moaning and groaning during the treatment regimen. CMS Ex. 1, at 1-2; see CMS Prehearing Br. at 9.

In deciding whether or not Petitioner is noncompliant with this participation requirement, I evaluate Resident 5's baseline condition (his bowel function when he arrived at the facility) compared to his condition throughout his residence at Petitioner's facility to determine whether there are discrete "tipping points" at which a fluctuation or fluctuations in Resident 5's condition might constitute a significant change requiring immediate notification of Resident 5's physician. ⁽¹²⁾ See Scallop Shell Nursing Home, DAB CR1171 (2004); Batavia Nursing and Convalescent Center, DAB CR1031, at 4-6 (2003). In this regard, I consider whether there was an actual change in Resident 5's clinical condition, not whether there was just a potential for such change.

While I find that Petitioner was out of compliance with Tag F 157, I am not convinced that Petitioner was out of compliance on all bases cited by the State or CMS. I am not convinced that Petitioner needed to notify Resident 5's physician when Resident 5's bowel movements decreased in August 2002. I agree with Petitioner that, given Resident 5's history of bowel problems, his reduced number of bowel movements during August 2002 would not necessarily constitute a significant change in Resident 5's baseline condition. See P. Br. at 12-13. Moreover, it is unclear whether a pattern of changes would have become apparent until the end of the month at a minimum. I am also not convinced that, under this section of the regulations, it was Petitioner's duty to notify Resident 5's physician "to discuss" the x-ray since it was ordered by Resident 5's physiatrist who would have received the report (although I come to a different conclusion with respect to Tag F 224, as discussed below). Finally, I am not convinced that Petitioner was out of substantial compliance with Tag F 157 (although I come to a different conclusion with respect to Tag F 224, as discussed below) when it failed to notify Resident 5's physician that Resident 5 refused two different bowel medications in a three step treatment regimen. This is because Tag F 157 goes to notification of significant changes in a resident's clinical condition, and there was no change in Resident 5's condition until after the administration of the GoLytely.

I find Petitioner out of substantial compliance with Tag F 157, however, for not notifying the physician that Resident 5 did not respond the to the GoLytely prep and with regard to the symptoms consequent to that, especially in light of Petitioner's diagnosis of autonomic dysreflexia. Petitioner had a duty, if nothing else, to understand adequately the needs of such an obviously difficult case and to understand the level of care to which it committed itself by admitting Resident 5. These two related and fundamental concepts are subsumed into the regulations and the F Tags at issue here, and they operate as the background against which the very specific facts of this case are evaluated.

Petitioner asserts that, although Resident 5 did not have a bowel movement within an hour after the GoLytely prep, this was a consequence of the way the product was used in his case--for the relief of constipation and administered more slowly than for colonoscopy prep--and its effects could be delayed. ⁽¹³⁾ Petitioner asserts that the failure to have a bowel movement in response to the GoLytely did not warrant a call to the physician. Petitioner refers to Dr. Rubino's testimony that the physician would likely have told the nursing staff to monitor the resident for signs of change. Tr. 957. Petitioner asserts that this is exactly what Petitioner did. P. Br. at 18-21.

The failure to have a bowel movement after consuming GoLytely is, as CMS notes (CMS Br. at 15), not typical. I agree with CMS (and note Dr. Rubino's testimony that a physician would want to know about signs of change or whether a resident finally did have a bowel movement). Dr. Stiens testified that signs of change indicating a deteriorating condition for Resident 5 would be pain, nausea, vomiting, unstable vital signs, and abnormal bowel sounds. Tr. at 374-75, 391. Nurse's notes and the fax sent to Dr. Reece show that Resident 5 had pain, nausea, vomiting, abnormal abdominal findings, and was sweating and trembling. Resident 5 had a history of autonomic dysreflexia, a very serious condition attendant upon distention and stool in the rectum which, as noted at footnote 2 above, is potentially life-threatening, a history that Petitioner was aware of from Resident 5's records. As of September 1, 2002, Resident 5 was showing significant symptoms following taking a serious bowel medication and it was incumbent upon Petitioner to consult with Resident 5's physician about these potentially significant clinical changes. I note Petitioner's assertion that the nausea, vomiting and abdominal cramps could have been signs of something less serious, including "stomach flu." P. R. Br. at 24. I find Petitioner's suggestions unconvincing. However, even if Resident 5 was simply suffering from a "stomach flu," given his condition it was up to Petitioner to notify and consult with Resident 5's physician as soon as these symptoms manifested precisely to allow the physician--and not Petitioner's nurses and not even Resident 5, notwithstanding how involved in his own care Resident 5 may have been--to make a determination as to whether the symptoms were serious.

2. CMS has made a prima facie case that, as of the survey ending on September 5, 2002, Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.13(c)(Tag F 224 on the statement of deficiencies), which Petitioner has not rebutted.

The regulation at 42 C.F.R. � 483.13(c) provides that a facility must "develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property." The statement of deficiencies asserts that Petitioner failed to "provide the necessary care and services in order to prevent the neglect of quadriplegic Resident #5 . . . ." CMS Ex. 1, at 7. The regulations define "neglect" as the "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. � 488.301. As Petitioner frames the issue, my inquiry here is to determine whether it "failed to provide or withheld goods and services necessary to avoid physical harm, mental anguish, or mental illness, such that Resident 5 was neglected." P. R. Br. at 3. As Petitioner notes (P. R. Br. at 34) in the case of Beverly Health and Rehabilitation - - Spring Hill, the Judge found that,

[t]he question that must be resolved in assessing whether Petitioner was deficient in giving care to [the resident] is not so much whether Petitioner accomplished or failed to accomplish the specific actions that are the basis for the surveyors' allegations, but, rather, whether Petitioner gave [the resident] the care that was necessary to address . . . problems consistent with the resident's physician's orders and the requirements of applicable regulations. It is a matter of judgment in a particular case for a facility's staff, in consultation with a resident's treating physician, to decide precisely which interventions are appropriate in each case.

Beverly Health and Rehabilitation - - Spring Hill, DAB CR553 (1998).

While I do not believe that Petitioner was uncaring, unconcerned, or inattentive in its treatment of Resident 5, I find below that Petitioner failed in its provision of services to Resident 5 in order to avoid physical harm. Petitioner relied too much on Resident 5's direction of his own care, abdicating too much of its responsibility to both Resident 5 and Resident 5's physicians to manage that care. ⁽¹⁴⁾ In this regard, even if a nursing facility is constantly checking on a resident, if it fails to provide services that resident needs it is still deficient.

CMS asserts that Petitioner is out of compliance with this regulation because it failed to: include Resident 5's most significant care issue, neurogenic bowel, in his care plan; develop an appropriate bowel program for him; respond to indications his bowel program was ineffective; provide him with frequent enough bowel care; recognize the importance of regular bowel care; notify his physician when he did not have a bowel movement in response to a Dulcolax suppository on August 10, 22, and 25; administer medications that didn't make his condition worse; discuss the appropriate use of Lomotil with his physician; follow up on Dr. Delaney's note of August 9, 2002; obtain the results of the x-ray; provide Resident 5 with the goods and services he needed in response to the results of the x-ray; address the deterioration in his condition following the x-ray; give ordered medications to help him evacuate his bowels; keep the physician informed about his condition; carry out the physician's order for an enema; call the physician when the resident refused the enema; assess his condition and notify the physician to determine whether GoLytely was appropriate; monitor him after the GoLytely administration; notify the physician timely that GoLytely had not produced a bowel movement; and respond to signs that his life was in danger. CMS Br. at 23-44.

I do not need to address each of CMS's assertions to find for CMS here. Instead, I find it to be sufficient that Petitioner was deficient in that: Petitioner never "care-planned" for Resident 5's bowel issues; Petitioner did not follow up on the x-ray; Petitioner did not inform Resident 5's physician that Resident 5 was foregoing an enema and going straight to drinking the GoLytely; and, most important, that Petitioner did not notify and consult with Resident 5's physician after Resident 5 had not produced a bowel movement after administration of the GoLytely or respond to signs that Resident 5 was in medical distress. I discuss each of these deficiencies below.

First, I agree with Dr. Stiens that what is notable about Resident 5's care plan is that neurogenic bowel is nowhere noted or planned for. Tr. at 288. Without planning for Resident 5's bowel care there was no way to ensure that repetitive daily care was delivered in such a way to ensure that care was being appropriately rendered. An accruing problem could become life threatening. Tr. 290. This is in spite of the fact that Petitioner formulated a plan of care on or about July 12, 2002, to address Resident 5's mobility, catheter, anxiety medications, the risk of skin breakdown, depression and weight. It is not enough for Petitioner to insinuate that Dr. Delaney or Dr. Reece, with Petitioner's suggestion, knowledge, or concurrence, ordered certain medications for his bowel problems and that they carried out those orders. The same could be said for the anxiety medications they care-planned for. It is inexplicable to me why, when Petitioner was careful to plan care for so many of Resident 5's other needs, it completely failed to do so for this most serious health issue.

Second, Petitioner was deficient in not following up on Dr. Delaney's progress note and the x-ray report. Petitioner asserts that it took reasonable means to follow up on the x-ray by faxing Dr. Delaney's office. P. Br. at 37-38. While it was reasonable for Petitioner to fax Dr. Delaney's office, when Petitioner did not get a response to the fax Petitioner should have continued to follow up. The fax sent to Dr. Delaney on August 12, 2002, which was re-sent on August 19, 2002, states "Resident saw Dr. Delaney on 8/9/02. Returned [with] order to [discontinue] Senokot, Dulcolax tabs . . . [Resident 5] is concerned that he is not cleaned out & progress noted states he might need Go-Lytely bowel prep. Do you want Go-Lytely ordered? . . . Also he would like to know results of the x-ray that was done on 8/9/02." P. Ex. 37, at 42. There is nothing of record to show that Petitioner followed up on this fax by calling Dr. Delaney's office to ensure that it had a response. This is in spite of the fact that Petitioner did both fax and call a physician to clarify medication orders when Petitioner was admitted, as reflected in the nursing notes on R5's admission on June 25, 2002. Resident 5 may have been developing a condition that Petitioner needed to treat. In not following up on the fax, Petitioner was unable to assure that Resident 5 was provided the nursing care Resident 5 needed because it simply did not have the information to do so.

Third, I agree with Petitioner that Resident 5 had a right to refuse to take the enemas in the first two steps of the three-step process ordered by Dr. Reece. P. Br. at 39-40. Petitioner was, however, deficient in not informing Resident 5's physician that Resident 5 was not complying with physician's orders. In spite of Petitioner's assertions to the contrary, Dr. Reece's order made it clear that he saw the treatment as a three-step process. It was incumbent upon Petitioner to let Dr. Reece know that Resident 5 was not following that order so that the physician could either change the order or discuss the situation with Resident 5.

Fourth, Petitioner was also deficient in its care of Resident 5 after it administered the GoLytely. Petitioner asserts that its staff actions were appropriate exercises of professional judgment consistent with the applicable standards of care. Petitioner stresses that facility nurses were attentive to Resident 5 and offered to transfer him to the hospital on two occasions, which he refused. Moreover, Petitioner stresses that Resident 5 was in control of his own care and incapable of being neglected. Finally, Petitioner asserts its nursing staff did not consider Resident 5's condition to be urgent, which is why they only faxed his physician, they didn't call him, not believing such notification and consultation was necessary. P. Br. at 41-43. I find Petitioner's assertions here to be symptomatic of the problems with its care of Resident 5, in that Petitioner essentially abdicated its responsibility to manage that care and provided services ad hoc, taking its cue from Resident 5 instead of administering proper nursing care in the absence of a plan of care or physician consultation.

Nurse's notes indicate that Resident 5 was administered the GoLytely at approximately midnight on September 1. GoLytely is supposed to produce a bowel movement within an hour. CMS Exs. 8, 9. Even accepting that Resident 5 was given GoLytely more slowly than indicated for colonoscopy prep, it is undisputed that Resident 5 did not have a bowel movement throughout the entire day on September 1 and did not have one until he was found in respiratory distress on September 2. Petitioner does not appear to have been monitoring Resident 5's condition during this time. When I evaluate Petitioner's nursing notes from the time the GoLytely was administered, I see an individual who was vomiting, whose abdomen was distended and hard, who asserted he was in "awful pain," was "moaning" and "groaning," and was vomiting a brown emesis. All Petitioner did was give him phenergen for the vomiting and observe him. Dr. Stein's testimony that Petitioner's staff should have monitored Resident 5's vital signs, assessed his abdomen and general condition and updated his physician (given Resident 5's symptoms, his general condition, and the risk of autonomic dysreflexia) is compelling, and it compels the conclusions I reach here. Tr. 374-75, 391. Given Resident 5's condition (a condition that, at least from the nurse's notes Resident 5 had never exhibited before) faxing the physician at 12:11 in the morning was inadequate.

3. A $5000 per day CMP from August 10, 2002 through September 2, 2002 is reasonable.

The evidence of noncompliance discussed above is of an unusually resident-specific nature: that is, the needs for special measures in Resident 5's care, the unique reasons those special measures were needed, and the particular points at which Petitioner failed to meet those needs, do not appear in general throughout the resident population at Petitioner's facility, and do not, insofar as I can say from the perspective of this case and this evidence, appear to have imperiled other residents there. CMS appears to have implicitly taken a similar view, since it cited the deficiencies here at a scope-and-severity level of "J," the most severe, extremely dangerous, level of noncompliance, but of an isolated scope, the narrowest scope of the range available for potential citation. If clarity in what follows will be served by an explicit finding on that point, then I so find: the noncompliance involved in this case was serious and placed Resident 5 in immediate jeopardy, but it was extremely limited in scope, and existed only for the period during which Resident 5, and only Resident 5, was in immediate jeopardy because of it.

While I could find that the immediate jeopardy began when Petitioner failed to care plan for Resident 5's bowel problems, I accept CMS's determination that the immediate jeopardy began when Petitioner failed to pursue the results of Resident 5's August 10, 2002 x-ray, and I find that it ended when Resident 5 died on September 2, 2002. I can find no logical justification for extending the period of noncompliance and the attendant $5000 per day CMP beyond that date on these facts. Whatever steps and corrective measures Petitioner may have taken, contemplated, failed to take, or disregarded, nothing done or undone after September 2, 2002, could have altered the sad march of events that led to Resident 5's death on that date. I can find nothing in this evidence to suggest that other residents in the facility were in immediate jeopardy on September 3, 4, or 5, 2002, as a consequence of the deficiencies I have sustained above. There should be no mistake about my view of this case: Petitioner's noncompliance was serious and resulted in dreadful consequences.

The total amount of the CMP I sustain here is the best reflection of my view. But, it is also my view that the noncompliance was so resident-specific and so fact-bound that logic and justice require that it be understood to have ended when Resident 5 died. Accordingly, while I sustain the CMP amount of $5000 per day beginning on August 10, 2002, I find and conclude that the period of Petitioner's noncompliance ended on September 2, 2002, three days earlier than alleged by CMS.

Richard J. Smith

Administrative Law Judge

1. As CMS notes (CMS Br. at 24, n.18), the statement of deficiencies cited a subsection of 42 C.F.R. � 483.13, subsection 483.13(c)(1)(i). However, the text of the regulation quoted in the statement of deficiencies is the language solely of section 483.13(c). At no time has Petitioner shown that the notice it received was not clear that CMS's contention is that Petitioner failed to comply with section 483.13(c), not subsection 483.13(c)(1)(i). Moreover, Petitioner has had ample time to prepare to defend itself against CMS's allegations concerning section 483.13(c). Thus, the citation to subsection (c)(1)(i) in the statement of deficiencies has not prejudiced Petitioner.

2. Nor is the hearing process better served by the tone, content, and vocabulary of CMS's Response Brief. That pleading employs rhetoric unsuited to legal argument; examples may be observed at pages 1-2, 16, 20, 26, 30, 31-33, 34, 36-37, and 44. CMS's response brief achieves its length of 45 pages without the citation of a single case, statute, or regulation.

3. The parties have submitted some duplicate copies of documents as exhibits in the case. For the sake of brevity, I do not refer to all copies in my citations.

4. I cite the factual background underpinning my decision in finding 1. I refer to the factual background in subsequent findings.

5. Autonomic dysreflexia was noted on Resident 5's North Carolina Preadmission Screening and Annual Resident Review (PASARR) (P. Ex. 11, at 129), as well as quadriplegia, recurrent UTI, recurrent pressure ulcers, chronic constipation, s/p partial gastrectomy, s/p drainage of right leg septic infection and suprapubic catheter placement. I take note that autonomic dysreflexia is defined as "a syndrome affecting persons with lesions of the spinal cord above the mid-thoracic level, characterized by paroxysmal hypertension, bradycardia, excessive sweating, facial flushing, nasal congestion, pilomotor responses and headache. It is due to an exaggerated autonomic response to such stimuli as distention of the bladder or rectum." Dorland's Illustrated Medical Dictionary, 27 ^th Edition, W.B. Saunders Co., Philadelphia, 1985. For individuals with spinal cord injuries such as Resident 5 ". . . stool in the rectum or any method of rectal stimulation may cause autonomic dysreflexia. This is a potentially life-threatening emergency medical condition! A fast, major increase in . . . blood pressure is the most dangerous sign of autonomic dysreflexia." CMS Ex. 47, at 11. As Dr. Stiens testified, "autonomic dysreflexia is a reflective increase in blood pressure that's observed with people with spinal cord injury that is precipitated by a pain stimulus or an over-filled viscus - a bladder being over-filled, a colon being over-filled, any pathologic process below the level of injury that causes an excessive sympathetic discharge reflex mediated by the spinal cord could drive the blood pressure way up. The blood pressure could go to very high levels and could cause stroke, it could cause a bleed in the brain." Tr. at 349-50; CMS Ex. 55. Petitioner was on notice of Resident 5's history of autonomic dysreflexia. P. Ex. 6, at 28, 45; P. Ex. 11, at 129, despite Petitioner's assertion that it was not. P. R. Br. at 23-24, n.19. As Petitioner had taken on the responsibility of a quadriplegic patient it was its responsibility to be aware of all the resident's diagnoses and how, as a nursing facility, to treat them.

6. CMS spent a great deal of time during the hearing process arguing that Petitioner was out of compliance with participation requirements because it did not use digital rectal stimulation to assist Resident 5's bowel movements. In contrast, Petitioner argued that Resident 5's physicians did not order such rectal stimulation and opines that such rectal stimulation is not the standard of care in Havelock, North Carolina. P. Br. at 31. I do not address the issue of digital rectal stimulation in this decision, as I do not find it necessary for me to do so to decide the case.

7. The drugs Resident 5 was taking in his bowel regimen have the properties described below. Lomotil is an antidiarrheal agent which inhibits gastrointestinal motility and has a constipating effect with toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, and abdominal discomfort as potential adverse reactions. CMS Ex. 42. Senekot is a laxative that should not be used without consulting a physician when abdominal pain, nausea, vomiting or fever are present (failure to have a bowel movement after its use might indicate discontinuance of use and consultation with a physician). CMS Ex. 45. Dulcolax is a laxative which, in suppository form, produces a bowel movement in 15 minutes to one hour. In tablet form, it usually produces a bowel movement in eight to 12 hours. It should not be used when there is an obstruction, abdominal pain, nausea or vomiting. Failure to have a bowel movement after its use might indicate a serious condition. CMS Ex. 43, at 2, 3, 6, 11, 13. Metamucil is a laxative contraindicated in persons with intestinal obstruction or conditions which might lead to obstruction. Taking inadequate fluid with Metamucil might cause obstruction of the large bowel and the failure to have a bowel movement after use of Metamucil might indicate a serious condition. CMS Ex. 41.

8. As CMS notes (CMS R. Br. at 6) it is unclear whether it was Dr. Delaney or Dr. Reece who instituted the three-day medication regimen of Lomotil on days one and two and a Dulcolax suppository on day three. The signature on the order for this regimen does appear to be Dr. Reece ( compare P. Ex. 11, at 27 with P. Ex. 11, at 15; P. Ex. 11, at 30 (where it appears both Dr. Delaney and Dr. Reece signed an August 9, 2002 order to give Dulcolax tabs daily if needed for no bowel movement, to discontinue Senokot, and to follow up with Dr. Delaney in one month). However, it appears that Dr. Delaney may have been under the misapprehension that Resident 5 was taking a Dulcolax suppository every other day in August 2002. P. Ex. 14, at 19.

9. Petitioner would have me infer from this that Resident 5 rejected Dr. Delaney's recommendation and that this shows Resident 5's ability to make his needs and wants known. P. R. Br. at 10. There is no support of record for this inference and I do not draw it.

10. The pages are handwritten. I transcribe them here as closely as possible.

11. Petitioner suggests that the medical examiner may have been wrong. However, I accept the Medical Examiner's findings, although my finding to the contrary would not change my decision in this case.

12. I recognize that Resident 5 was seeing two physicians for his bowel condition: Dr. Reece, his facility physician, and Dr. Delaney, his physiatrist. However, for the purposes of notification of a significant change, I mean that Dr. Reece should have been notified, unless I specifically state otherwise.

13. According to Dr. Rubino, GoLytely's intended use is to thoroughly clean out the bowel in anticipation of a colonoscopy. It has also been used for individuals with resistant constipation as a secondary of off-label use. Tr. 930. When administered as an off-label use for constipation, especially when the product is not consumed as quickly as indicated in the instructions, effects may be delayed. Tr. 938.

14. I note here Petitioner's argument that nursing staff in a long-term care facility do not have a duty to review, critique, supervise and second guess the clinical judgment, determination and orders of attending physicians and that the failure to do so does not constitute neglect of a resident. P. Br. at 26-29. Petitioner relies on an administrative law judge's decision in the case of Beverly Health and Rehabilitation - - Spring Hill, DAB CR553 (1998) for this assertion. The holding in that case, however, is not as broad as Petitioner posits. On review of the judge's decision, an appellate panel noted that an appellate panel decision in Cross Creek Health Care Center, DAB No. 1665 (1998) found that a physician's order does not absolve a nursing facility from the independent responsibility to provide care in compliance with the regulations. In fact, a nursing facility has an independent obligation to plan for and provide services to meet the medical needs of each resident and to help each resident maintain the highest practicable physical well-being (Act, section 1819(b)(2)) outside of any physician orders. Nursing staff have the responsibility to exercise professional judgment in questioning a physician's instructions. However, nursing staff are not required to challenge those judgments that physicians make which are uniquely within the skill and training of a physician, but only those decisions that a professional with the training and expertise of a nurse could evaluate as incompetent and jeopardizing to a patient. Beverly Health and Rehabilitation - - Spring Hill, DAB No. 1696, at 39-44. In making my decision here I do not rely on an instance where Petitioner would have to contest a physician's judgment. I focus solely on Petitioner's actions as a nursing facility and the responsibilities attendant to that role.