SUBJECT:

IHS at Theron Grainger,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

IHS at Theron Grainger (Petitioner or facility), is a nursing facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare and Medicaid Services's (CMS's) determination that it was not in substantial compliance with program participation requirements on January 21 through January 22, 2000.

For the reasons set forth below, I conclude that the facility was not in substantial compliance with program participation requirements on January 21 through 22, 2000, and that the civil money penalty (CMP) imposed - $10,000 per instance - is reasonable.

I. Background

On April 5, 2000, an individual called the Texas Department of Human Services (State Agency) to complain that the facility had provided inappropriate care to one of its residents (Resident 1). According to the complainant, Resident 1 pulled out a recently-inserted feeding tube. Instead of transferring him to an acute care hospital for reinsertion of the tube, as his family requested, the facility's director of nursing (DON) performed the procedure, but, according to the complainant, she incorrectly re-inserted the tube so that it did not go into his stomach. The resident became acutely ill, was hospitalized, and died shortly thereafter. CMS Exhibit (CMS Ex.) 4.

Responding to the complaint, the State Agency conducted a complaint investigation survey on May 9, 2000, and determined that from January 21 through 22, 2000, the facility was not in substantial compliance with the requirements set forth in 42 C.F.R. � 483.20(k)(3)(i) because services provided to Resident 1 did not meet professional standards of quality. CMS agreed, and, by letter dated May 31, 2000, advised Petitioner of its decision to impose a per-instance civil money penalty (CMP) of $10,000 based on this instance of noncompliance. CMS Ex. 1.

Petitioner timely requested a hearing.

CMS filed a motion for summary judgment. Petitioner opposed, arguing that material facts are in dispute. I note that the ultimate "fact" Petitioner represented as in dispute - whether a challenged procedure is consistent with professional standards of quality - is not a question of fact, but a conclusion of law. Nevertheless, Petitioner credibly alleged an arguably relevant factual dispute with respect to conversations between Ms. Mary Corley, the physician's assistant (PA) who ordered reinsertion of the feeding tube, and Ms. Dona Johnston, the facility's Director of Nursing (DON). We therefore held a hearing by telephone on June 22 and June 27, 2001, to take the testimonies of PA Corley and DON Johnston. Ms. Claire Langford and Mr. John Rivas appeared on behalf of Petitioner. Ms. Katherine W. Brown and Ms. Quyona Gregg appeared on behalf of CMS. CMS Exs. 1 through 26 and Petitioner's Exhibits (P. Exs.) 1 through 32 were admitted into evidence. ⁽¹⁾ With its post-hearing brief, Petitioner submitted supplemental affidavits from licensed vocational nurse (LVN) Betty Parker, and Denise Helms, RN, to which CMS has voiced no objection, and those affidavits are admitted into the record (referred to as Parker Affidavit and Helms Affidavit).

II. Issue

This case presents a narrow question: whether the facility met the requirements of 42 C.F.R. � 483.20(k)(3)(i). Specifically, did its actions in replacing a newly placed percutaneous endoscopic gastrostomy (PEG) tube meet professional standards of quality?

If the facility did not meet program requirements, is the amount of the CMP imposed, $10,000, reasonable?

In its post-hearing brief, Petitioner raises, for the first time, the issue of whether the purported level of its noncompliance meets the degree of egregiousness sufficient to justify imposition of a CMP for past noncompliance, as set forth in section 7510 of the State Operations Manual (SOM). Although CMS complains that Petitioner did not raise the issue in its appeal, without considering whether the issue is properly before me, I conclude that section 7510 does not apply here.

III. 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 to promulgate regulations implementing the statutory provisions. Act, sections 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 and 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, section 1819(b); 42 C.F.R. � 483.25. The services provided or arranged by the facility must meet professional standards of quality. 42 C.F.R. � 483.20(k)(3)(i).

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 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). When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 per instance. 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.

IV. Burden of Proof

If CMS establishes a prima facie case that the facility was not in substantial compliance, the facility, in order to prevail, must prove, by a preponderance of evidence, its substantial compliance with program participation requirements. Emerald Oaks, DAB No. 1800, at 4 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999).

V. Discussion

In January 2000, Resident 1 was an 80-year-old man suffering from Alzheimer's disease. On January 12, 2000, he was admitted to Longview Regional Medical Center with lower lobe pneumonia, as well as anemia with malnutrition. CMS Ex. 9, at 42 - 43. During his hospital stay, he started to experience atrial fibrillation with rapid ventricular rate, as well as periods of respiratory distress, especially after feedings. Swallowing studies showed a high risk for aspiration, so, on January 19, 2000, he underwent PEG tube placement. P. Ex. 8; CMS Ex. 9, at 3. ⁽²⁾

Resident 1's PEG tube was inserted surgically with an endoscope through his mouth and esophagus into his stomach. A stab incision was then made through the wall of the abdomen into the stomach, creating a track through which the tube exited. CMS Ex. 9, at 58; CMS Exs. 18, 25 (Bennett Affidavit) at 1; Transcript (Tr.) from June 27, 2001, at 7. He was started on PEG feedings which he tolerated well without complications. At the time of his discharge from the hospital, his lungs were clear.

Resident 1 was discharged to the facility at 7:00 PM on January 21, 2000, with orders that included PEG feedings and aspiration precautions. CMS Ex. 9, at 3-5. Although in restraints at the time of his admission to the facility, nursing notes describe him as "calm," and the restraints were removed. P. Ex. 14, at 1; CMS Ex. 10, at 7. According to a treatment note, the resident's family was visiting that evening, but when they left the room, at 10:30 PM, he pulled the PEG tube out. CMS Ex. 10, at 7. ⁽³⁾ Resident 1's treating physician had delegated to his physician's assistant (PA), Mary Corley, the authority to issue orders to care for patients, and, on the night of January 21, 2000, she was on call. According to treatment notes, at 10:35 PM, facility staff called her to report the PEG's removal, and she issued orders to replace it. P. Ex. 14, at 1; CMS Ex. 10, at 7. In her testimony, PA Corley flatly denied ordering facility staff to reinsert the PEG tube at the facility, but claimed that she instructed LVN Betty Parker, to send Resident 1 to the emergency room. Tr. from June 22, 2001, at 16, 28, 29, 30, 35.

Both LVN Parker, who wrote the treatment notes, and DON Johnston challenge PA Corley's testimony. According to Ms. Johnston's testimony, LVN Parker called her home at 10:30 to say that Resident 1 had pulled out his PEG tube. She instructed the LVN to ask PA Corley to come into the facility to replace the tube. Tr. from June 27, 2001, at 12. Ms. Johnston further testified that Ms. Corley called her at about 10:30 PM and they specifically discussed that the tube was new. Because Ms. Johnston lived closer to the facility, she agreed to go in and replace it. Tr. from June 27, 2001, at 13-14. Ms. Johnston did not document the conversation. Moreover, in a statement dated February 14, 2000, Ms. Johnston described her 10:45 PM telephone conversation with Mary Corley, but did not mention any discussion of the PEG tube. According to Ms. Johnston's February 14 statement, she and Ms. Corley discussed whether to use wrist restraints. P. Ex. 28. Surveyor notes reflect Surveyor Rose's May 2, 2000 interview of DON Johnston. According to the notes, Ms. Johnston called Mary Corley and they discussed restraining with hands and body wrap. Again, DON Johnston did not mention any discussion of the tube. ⁽⁴⁾ P. Ex. 29, at 1-2. PA Corley flatly denied having a conversation about the PEG tube with DON Johnston. Tr. from June 27, 2001, at 39; Tr. from June 22, 2001, at 28. When she was interviewed by Surveyor Rose, she said that if she'd been told the tube was new, she would have insisted that Resident 1 be sent to the emergency room (ER). P. Ex. 29, at 6. On the other hand, LVN Parker told the surveyor that she told PA Corley that she could not replace the tube because it was new and she did not replace new tubes, indicating that the PA knew or should have known that this was a newly inserted tube. P. Ex. 29, at 7.

In any event, both parties agree, and the treatment records confirm, that at 11:00 PM, DON Johnston came into the facility and re-inserted the PEG tube. DON Johnston testified that she inserted the tube, expressed stomach contents, instilled 30 ccs of air and listened with her stethoscope over the stomach to hear air. Id. at 16. She did not document that she checked for tube placement (Tr. from June 27, 2001, at 17), but an 11:00 PM nursing note signed by B. Parker LVN states:

Peg tube #22 Fr [with] 15 balloon insert per Dona Johnston, RN, DON [without] any difficulty. Gastric secretions noted - aw part flushed [with] 50 cc H2O -Resident tol (sic) procedure well.

P. Ex. 14, at 2; CMS Ex. 10, at 8.

Subsequent notes signed by LVN Parker describe the resident as "constantly picking" at his abdomen. P. Ex. 14, at 3; CMS Ex.10, at 9. At 3:00 AM he again pulled out the PEG tube. Id. ⁽⁵⁾ PA Corley was again notified, and the nursing note states: "orders to replace peg tube or transfer to Good Shepherd ER." Again, in her testimony, PA Corley denies having ordered tube replacement at the facility. A 3:25 AM entry signed by LVN Parker states: "unable to insert peg tube at present time," suggesting that she attempted, but failed, to reinsert the tube. In her affidavit, LVN Parker does not mention or explain this entry, although, according to the survey report form, she told the surveyor that she unsuccessfully attempted to replace the tube after DON Johnston told her that "a new G/T is the same as [an] old GT." CMS Ex. 2, at 4; P. Ex. 29, at 7. However, the Parker affidavit includes no reference at all to her early morning telephone call to DON Johnston. See Parker Affidavit.

DON Johnston testified that she went home after re-inserting the tube at 11:00 PM, but that at 3:30 AM, LVN Parker called her at home to say that the resident had again pulled out his tube. Nurse Johnston returned to the facility, reinserted the tube, and, according to her testimony, she checked for gastric juices, instilled air, flushed with 50 ccs of water. Both she and LVN Parker auscultated. ⁽⁶⁾ Id. at 19. Again, she did not document. A 3:45 AM entry in the treatment record confirms that DON Johnston inserted the PEG tube, and the tube was flushed, but says nothing about her (or the LVN) checking for appropriate placement. Id. ⁽⁷⁾

A 4:00 AM entry indicates that the resident tolerated feeding. At 5:00 AM, LVN Parker's last entry describes the resident as resting quietly in bed, but "rubs" abdomen at "internals - Denies pain." P. Ex. 14, at 4.

Entries made by different staff at 6:00 AM and 9:00 AM indicate that the LVN checked on PEG placement. The 6:00 note contains no detail, but the 9:00 note indicates that the LVN checked the PEG tube via aspiration of stomach contents and air auscultation, that the PEG was in place, and that she administered medications and fed him. P. Ex. 14, at 4; CMS Ex. 10, at 10. However, when the LVN next checked on the resident, at 11:15 AM, her note describes rapid respiration and bilateral lung congestion. She states that the PEG tube is in place, but does not explain the method by which she made that assessment. P. Ex. 14, at 5. The facility called PA Corley, who instructed staff to send the resident to the emergency room. Id.

He was picked up by ambulance at 11:40 AM. According to the EMS (emergency medical services) report, the facility reported that Resident 1 rapidly developed difficulty breathing. He is described as in respiratory distress, skin pale, very diaphoretic, rales up and down, right and left lobes. CMS Ex. 11, at 1.

When Resident 1 left the facility, he was in critical condition. P. Ex. 15, at 1; CMS Ex. 10, at 13. He was admitted to the hospital at 12:10 PM on January 22, 2000, in respiratory distress, with aspiration pneumonia. The Emergency Room physician listed sepsis among his clinical impressions. CMS Ex. 12, at 31. The admitting physician, Dr. George Smith, also noted Resident 1's recent PEG tube placement and history of aspiration, "which could obviously have occurred with this episode." CMS Ex. 12, at 36.

Soon thereafter, the hospital noted problems with Resident 1's PEG tube, which was placed on wall suction at 3:30 PM the afternoon of January 22. Treatment records from then through January 23, 2000, indicate that PEG tube suction was draining "thick cloudy material," later described as "thick purulent type material," with "large amounts of mucous," which continued to drain from the PEG tube throughout the day and into the next day. CMS Ex. 12, at 6-7, 12. By evening, the staff withheld his Depakote because of the large amount of output from the PEG tube. Id. It appears that the Depakote was the only medication he received at the hospital by tube. Most of his medications were administered subcutaneously or through an IV. See CMS Ex. 12, at 11, 13-18. Throughout his time at the hospital, he was given a total of four doses of Depakote, but did not receive tube feedings. CMS Ex. 2, at 7.

An abdominal x-ray taken January 24 showed "leakage into the free peritoneal cavity from the PEG tube. . . ." CMS Ex. 12, at 23. The radiologist opined the free peritoneal air was explained by recent placement of a PEG tube. P. Ex. 27, at 3, 4. On the morning of January 24, Resident 1's family signed permission for an exploratory laparotomy, which was performed and confirmed that he had "peritonitis due to intraperitoneal tube feedings." CMS Ex. 5, at 5; P. Ex. 20, at 1; CMS Ex. 12, at 24.

Resident 1 died on January 29, 2000. CMS Ex. 12, at 33-34. His final diagnoses included pneumonia, acute respiratory failure, pulmonary embolism and infarct, anoxic brain damage, gastrostomy complication, peritonitis, ⁽⁸⁾ rib fracture, disorder of the peritoneum, Alzheimer's disease, dementia, and fracture of the clavicle. P. Ex. 23; CMS Ex. 12, at 20.

VI. Findings of Fact and Conclusions of Law

I make the following findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below in italics and bold as a separate heading. I discuss each Finding in detail and address Petitioner's arguments.

1. The facility did not meet the requirements of 42 C.F.R. � 483.20(k)(3)(i) because its actions in replacing the PEG tube did not meet professional standards of quality.

I first consider whether DON Johnston's actions in twice re-inserting the new PEG tube comported with professional standards of quality. To meet professional standards of quality, services must be provided according to "accepted standards of clinical practice." Standards may vary, depending on the particular clinical discipline or specific clinical situation or setting. See State Operations Manual (SOM), Appendix PP, PP-82.4.

The parties agree that if a PEG tube becomes dislodged, its proper reinsertion is critical. Not properly placed, the PEG tube may end up leading into the peritoneal cavity instead of the stomach. Localized wound infection, sepsis, peritonitis, and death are possible outcomes when feeding solutions are introduced into the peritoneal cavity. CMS Ex. 21, at 2; CMS Ex. 24 (Tennison Affidavit); CMS Ex. 25 (Bennett Affidavit); Tr. from June 27, 2001, at 30. The parties also agree that replacing a newly-inserted feeding tube is much more difficult than replacing an older one. It takes between ten days and two months to establish a track through which the PEG tube exits the body. Once the track is established, the tube can be replaced with little likelihood of deviation into the peritoneal cavity. However, as DON Johnston testified, before the track is established, "it's just a hole in the stomach and a hole in the outer wall. And it is difficult to get it." Tr. from June 27, 2001, at 8; see also Tr. from June 22, 2001, at 23 (PA Corley testimony); CMS Ex. 18, at 1; CMS Ex. 25, at 2 (Bennett Affidavit); CMS Ex. 21, at 2. ("There's a greater likelihood that the tube will wind up in a blind pouch or the peritoneal space if the stoma track isn't fully formed. . . .").

CMS relies primarily on information contained in professional journals, ⁽⁹⁾ and the declarations of its own health care professionals to argue that where a nursing home resident removes his recently surgically inserted PEG tube, accepted standards of clinical practice require that the tube be re-inserted at a hospital where adequate facilities are available to verify appropriate tube placement. Among the literature submitted by both parties, I found most persuasive, and most applicable to this case, the official recommendations from the American Gastroenterological Association (AGA), approved by their Governing Board on November 11, 1994, which state:

[u]nintentional removal of a PEG within the first week can be managed by replacing the PEG endoscopically. This has avoided complications of peritonitis and the need for possible laparotomy.

CMS Ex. 26, at 2-3 (emphasis added).

The AGA recommendation directly addresses the question of the appropriate procedure for replacing a newly-inserted PEG tube. Consistent with the AGA recommendation, an article published in the American Journal of Nursing cautions that if the tube becomes dislodged during the first 14 days, "notify the physician immediately; don't reposition . . .

However, if a tube that's at least 14 days old migrates inward, you can readjust it. . . ." CMS Ex. 18, at 1 (emphasis added).

Other authoritative sources in the record discuss procedures for routine enteral feedings, when there is no particular reason to suspect tube misplacement. Though not directly addressing the issue of replacing a newly inserted tube, they offer additional guidance, particularly in detailing what is required to confirm that an aspirate is gastric. The literature consistently stresses the importance of proper tube placement, and several articles rate the effectiveness of the various methods for determining placement. Petitioner submits a section from Mosby's Fundamentals of Nursing which states:

[t]he most accurate method for checking feeding tube placement is x-ray examination; the most effective nonradiological methods include aspirating fluid from the feeding tube and measuring its pH and describing its appearance.

P. Ex. 2, at 5. According to the text, x-ray verification is "required in most acute care facilities when small-bore tubes are initially inserted." Id. (emphasis added). The text recognizes that x-ray verification prior to every feeding is not practicable, but instructs the nurse to verify tube placement prior to feeding by aspirating gastric secretions, observing their appearance, and checking pH, then returning the aspirated contents to the stomach. The text specifically contrasts the appearance of gastric fluid (usually cloudy and grassy green or tan to off-white in color) with that of intestinal fluid (usually deep golden yellow, and more clear than gastric fluid). ⁽¹⁰⁾ P. Ex. 2, at 3-4.

A second text, Medical Surgical Nursing by Lewis, Heitkemper, and Dirksen, concurs:

[p]roper placement of the tube in the stomach should be checked before each feeding . . . . Methods used to check for tube placement can include aspiration of stomach contents and checking the pH of contents using a pH meter or pH paper. . . . [T]he most accurate assessment for correct tube placement is by x-ray visualization.

P. Ex. 3, at 5-6. See also P. Ex. 1, at 4 (Prior to feeding, the nurse should aspirate the stomach contents and measure the pH of the residual).

Theresa Bennett is a registered nurse and Long Term Care Enforcement Coordinator for CMS in Region VI. Her opinions conform to the AGA recommendations. According to Coordinator Bennett:

[i]t is a well-established clinical practice, when a PEG tube comes out shortly after surgical insertion, that the patient should be sent to the hospital so that a physician can reinsert the tube and verify proper placement by x-ray technology. This is the accepted clinical practice when the abdominal stab wound through which the PEG tube is inserted is still fresh or unhealed. Once the wound has had a chance to heal and form an established track or channel, reinsertion of a PEG tube by a nurse is acceptable. . . .

Removal of the tube that soon after surgical placement almost certainly resulted in the immediate closing up of the incision site; this closing of the incision site creates a very real possibility that the PEG tube, if reinserted without fluoroscopy or x-ray confirmation, could end up leading to the peritoneal cavity instead of the stomach. Therefore, the clinical practice of sending the resident to the hospital for placement of the tube by a physician and x-ray verification is critically important to assure proper reinsertion and placement.

CMS Ex. 25. Similarly, Nurse Surveyor Lucienne Tennison, a licensed registered nurse who is also a certified gerontological nurse, agrees that the accepted standard for verifying proper placement of a new tube is by x-ray. CMS Ex. 24.

Dr. George Smith was Resident 1's treating physician during his final hospital stay and the physician who dictated Resident 1's final discharge summary. On May 9, 2000, Dr. Smith told Surveyor Peggy Rose that the transcription of the discharge summary was in error, and should read "history of recent percutaneous endoscopic gastrostomy placement with a history of aspiration and replacement of tube by nursing personnel . . . inappropriately placed in peritoneal tracks." ⁽¹¹⁾ He specifically recalled Resident 1, and, consistent with his entries in the medical record, he told the surveyor that it was not appropriate for nursing personnel to replace a new PEG tube, and that the resident should have been sent to the emergency room for replacement. CMS Exs. 5, at 5; 17, at 8; and 24.

CMS has thus met its initial burden of establishing the standard of care required by the regulation (see Lake City Extended Care Center, DAB No. 1658 at 9, n.7 (1998)), and establishing that the facility failed to meet that standard of care. The evidence discussed above more than satisfies CMS's obligation to establish a prima facie case.

To meet its burden, Petitioner draws different inferences from the medical literature, relies on declarations and testimony from its own health care professionals, argues that DON Johnston was not responsible for the inappropriate tube placement, and asserts that, so long as she acted pursuant to a valid physician's order, DON Johnston's actions were within the standard of care. See Helms Affidavit. ⁽¹²⁾

With respect to the inferences to be drawn from the literature, the parties acknowledge that the nursing texts contain few references to replacing a newly-inserted PEG tube. I reject Petitioner's explanation for this apparent omission: that "the act has not lead (sic) to complications enough to warrant being addressed." P. Post-Hearing Brief at 6. I find it unlikely that the text's authors would devote so much attention to replacement of a tube in a well-established track, a relatively safe and easy procedure, but not mention the more difficult and problematic replacement of a newly-inserted tube unless they did not anticipate that a nurse would perform the procedure. More likely, they anticipated that the procedure would be performed in an acute care setting, probably by a physician with endoscopy.

Petitioner, nevertheless, points to a 1996 RN Magazine article, which appears to suggest that a nurse may re-insert a PEG tube and appropriately confirm placement solely by obtaining a gastric aspirate.

[w]henever you insert a balloon, obtain a gastric aspirate to verify proper placement before initiating feeding. If you're unsure whether an aspirate is from the stomach or you can't obtain one, confirm tube placement with an X-ray - particularly if the tube was inserted into a new stoma or one that hasn't been used for two or three weeks.

CMS Ex. 21, at 2. In a sidebar, the article sets out procedures for replacement of a G-tube that include the instructions to "verify that the tube has been placed properly by obtaining a gastric aspirate or, if necessary, having the physician order an X-ray. Document the tube insertion, including the volume of fluid used to inflate the balloon." CMS Ex. 21, at 2. Petitioner points to this language to argue that DON Johnston's actions were appropriate because she checked for gastric return. But critical to the process discussed in that article is that staff correctly identify the aspirate as gastric. Mosbey's, which I consider an authoritative source, instructs the nurse to measure pH and describe the appearance of the aspirating fluid. So, even if, arguably, a facility nurse could appropriately replace a newly inserted PEG tube, and confirm its placement solely by means of aspirating fluid, she must confirm that the aspirate is gastric. Petitioner admits that it has no ability to measure pH because it keeps no pH paper. Nurse Johnston testified that she simply relied on her observation of the aspirate (Tr. from June 27, 2001, at 35), which, according to the literature is an unreliable means, and she did not even provide a description of the aspirate in the treatment notes, so we have no way of knowing exactly what she observed.

The bulk of authority, including Petitioner's own submissions, supports CMS's view. As discussed above, the AGA recommends endoscopic replacement (CMS Ex. 26, at 2-3); the American Journal of Nursing instructs nurses not to reposition if the tube is less than 14 days old (CMS Ex. 18, at 1); Mosbey's Fundamentals of Nursing notes that x-ray verification is required in most acute care facilities. I recognize that standards of care may differ based on the clinical setting, but that is precisely why some potentially dangerous procedures should not be performed in clinical settings that are ill-equipped to perform them safely. Here, the facility did not have the capability for determining the appropriate placement of the newly inserted PEG tube by any of the means described as acceptable in the literature, and facility staff should therefore not have performed the potentially life-threatening procedure. ⁽¹³⁾

I am not persuaded that CMS has been inconsistent in defining the standard of care, as Petitioner claims. P. Brief at 9, et seq. In replacing a newly inserted PEG tube, the evidence sets out a number of practices that might be considered within the standard of care, which the facility could have followed to insure proper tube placement: (1) the facility could have sent Resident 1 to the hospital which had the facilities (endoscopy, x-ray) to ensure proper placement; (2) staff could have tested the gastric contents in a more reliable way, using pH paper, as prescribed by Petitioner's literature; ⁽¹⁴⁾ or (3) staff could have obtained an x-ray to ensure proper placement. DON Johnston testified that it would have been possible but would have taken 4-5 hours. The facility could have delayed feeding until after it confirmed that the tube was properly in place. However, blind replacement of a newly inserted tube, without employing a reliable means of confirming proper placement, falls short of the standard of care.

Petitioner also denies that facility staff were responsible for placing the tube into Resident 1's peritoneum instead of his stomach. As a matter of law, I find this a peripheral issue: even if staff had inserted the PEG tube into the stomach instead of the peritoneum, performing that procedure in a clinical setting without a reliable means of confirming placement violated the standard of care for nursing. Besides, as a factual matter, the evidence strongly suggests that the misplacement occurred when DON Johnston re-inserted the tube.

Petitioner attempts to shift the blame for the displacement either to the EMS team or to the hospital, but the evidence establishes that the problem more than likely began at the facility. No other circumstance presented so much risk of misplacement. The literature warns of the significant risk of putting the tube in the wrong place when the track is not yet formed. Moreover, DON Johnston was herself inexperienced in replacing a newly inserted PEG tube. She admitted that she had done so only twice before, and both instances were at an acute care hospital, and prior to 1994. Tr. from June 27, 2001, at 8, 27, 41. She thus had never re-inserted a brand new PEG tube in a nursing home setting, and had not replaced one in any other setting in more than six years. Her lack of experience undermines the Helms affidavit assertion that nurses in long-term care develop the skills to replace PEG tubes based on the frequency of the need for replacement. DON Johnston may well have replaced tubes in established tracks, but she was not experienced in replacing newly inserted tubes. I note also that by 3:30 AM she was tired, having been rousted out of bed for the second time that night. I do not consider this a very promising scenario for performing a difficult procedure that she had performed only twice before, many years prior, and in an acute hospital setting. ⁽¹⁵⁾

I reject Petitioner's and Nurse Helms' claim that "the sequence of events clearly show that the resident did not present to the ER with signs or symptoms of complications related to the PEG tube reinsertion." Symptoms characteristic of a misplaced feeding tube began within hours of Resident 1's first feedings following the tube replacement. Hospital staff certainly suspected tube misplacement early on and, when checked by a reliable method, determined that it had been misplaced. Dr. Smith, the admitting physician, opined that aspiration "could obviously have occurred with this episode" (referring to the PEG tube replacement). CMS Ex. 12, at 36. The emergency room doctor suspected sepsis and listed it among his clinical impressions. CMS Ex. 12, at 31. "Thick purulent" material - evidence of infection - drained from the tube from the time hospital staff began the suction, which was within hours of his admission. CMS Ex. 12, at 6-7, 12. Resident 1 was ultimately diagnosed with "peritonitis due to intraperitoneal feedings," confirmed by the laparotomy, precisely the adverse outcomes the AGA anticipated and sought to prevent with its recommendations. I note also that Resident 1 did not receive any tube feedings at the hospital. P. Ex. 20. Moreover, that staff "repeatedly documented that the tube was appropriately placed" (P. Brief at 3), means little where staff did not employ a reliable means for making that determination. Based on all of this, I conclude that a preponderance of the evidence establishes that DON Johnston incorrectly inserted the PEG tube into Resident 1's peritoneum rather than his stomach.

2. That the procedure may have been ordered by a physician's assistant does not relieve Petitioner of its obligation to meet professional nursing practice standards.

In Petitioner's view, so long as it notified the PA and followed her orders, it met the standard of care. P. Post-Hearing Brief at 2. Citing her conversation with an unnamed "prominent gerontologist," Nurse Helms asserts that

the discussion of the replacement of the PEG tube with the [nurse practitioner] and the signature of the Physician on the telephone order support that the nurses acted appropriately in replacement of the PEG.

Helms Affidavit. ⁽¹⁶⁾ That PA Corley did not order Resident 1's immediate transfer to the hospital or x-rays to verify appropriate placement, Petitioner argues, relieves the facility of its obligation to pursue those avenues. P. Brief at 3.

I note first that CMS has not cited as a deficiency any failure to obtain a valid physician order, and the record contains telephone orders to replace the PEG tube that are dated January 21, 2000 at 10:35 PM and January 22, 2000 at 3:10 PM (which is unquestionably an error and should read 3:10 AM). They were written by LVN Parker, and were subsequently signed by the physician, although the physician signature is not dated. P. Ex. 16. The orders simply call for tube replacement, setting forth the specific type and size tube. Nothing in the written orders suggests the circumstances under which the procedure should be performed.

To establish that it received guidance as to those circumstances, Petitioner points to its version of the staff's telephone conversations with PA Corley. According to Petitioner, staff advised Ms. Corley of the age of the tube, and she acquiesced with DON Johnston's plan to replace it at the facility. PA Corley, however, seems to recognize that a transfer order would have been appropriate, but she defends her actions - or inaction - by claiming that she did not understand that the PEG tube was newly inserted. For the most part, I found Ms. Corley's testimony confusing and inconsistent. ⁽¹⁷⁾

However, on this particular point, she has been consistent over time. She told the CMS surveyor that she had not realized the age of the PEG tube, and that if she had known it was so recent, she'd have insisted that Resident 1 be sent to the ER for replacement of the tube. CMS Ex. 17, at 4; Tr. from June 22, 2001, at 15. The surveyor investigative report indicates that in a conference call on May 8, 2000, Ms. Corley told Surveyor Rose and MDS Coordinator, Trish Buckner, RN, that "the nurse said she could not replace it, so I told her to send him to the hospital . . . The next phone call I received was from Betty Parker, LVN, stating that they had re-inserted the tube and had gastric returns." Asked if she'd have done anything different had she known the PEG tube was new, she said that she did not honestly remember the staff telling her that it was a new tube. "If I knew I would have insisted for him to be seen in the emergency room, if it's not a well found track or channel, it takes 10-14 days for a channel to be formed." CMS Ex. 5, at 3. Consistent with those statements, she testified that "the facility never told me the age of the PEG tube." Tr. from June 22, 2001, at 17.

On the other hand, DON Johnston has not been as consistent in describing the contents of her telephone conversations with PA Corley on the night of January 21-22. Initially in her testimony she said.

[w]e talked about his agitation, his multiple health problems, his - the fact that, when he came in, he had four-point restraints on and how that seemed to make his agitation worse. And [PA Corley] told me that if she came in to do the tube, it would take her probably over an hour to get there, and that would be too late.

Tr. from June 27, 2001, at 13. When subsequently specifically asked, she testified that they discussed the fact that the tube was new. Id. However, in her earlier descriptions of the phone conversation, she did not mention discussing the PEG tube. In her February 14, 2000 statement, she said that they discussed wrist restraints. P. Ex. 28. In a May 2, 2000 interview with the surveyor, she said that they discussed restraints. P. Ex. 29, at 1-2.

I think most likely facility staff simply assumed, without specifically telling her, that the PA understood that the tube was new. Resident 1 had been PA Corley's patient prior to his hospitalization, and Petitioner makes a reasonable argument that she should have known the age of the PEG tube. On the other hand, he was one of approximately 150 patients (Tr. from June 22, 2001, at 43), she apparently did not treat him during his hospitalization, he had been hospitalized almost 10 days earlier, and I do not find it incredible that she hadn't realized the age of the PEG tube. In any event, PA Corley's potential culpability does not excuse the facility from its independent obligation to ensure that professional standards of quality are met. Nothing in the written order suggests permission to perform outside the parameters of good practice, and Petitioner has an independent obligation to meet those standards without regard to physician orders.

Petitioner relies on Judge Kessel's decision in Beverly Health and Rehabilitation, DAB CR553 (1998), for the proposition that the facility has no responsibility to question physician judgment if a physician decision seems inappropriate. P. Brief at 11.

Petitioner argues -

Judge Kessel recognized that some medical professionals, such as physicians and nurse practitioners, have training and skills above and beyond others, such as registered nurses and vocational nurses, and that those with lesser skills are not required to question the judgment of those with more skills and training.

P. Brief at 12. Petitioner misinterprets Judge Kessel's ruling. As the appellate panel noted in reviewing Judge Kessel's decision, the ALJ did not conclude that nursing staff have no responsibility to exercise professional judgment in questioning physicians' instructions that appear to jeopardize a patient.

[h]e clearly distinguished the situation as presented at the hearing from cases where nurses could determine, based on their professional training and expertise, that the treatment ordered was contraindicated by the patient's medical signs or that medication was prescribed in an erroneous dosage. . . . The ALJ did not suggest that physicians' actions are beyond challenge by nurses but only that nurses are not required to challenge those judgments that physicians make which are "uniquely within the skill and training of the physician."

Beverly Health and Rehabilitation, DAB No. 1696, at 42-43 (1999).

In this case, nothing required staff to question the judgment of a physician (or PA) about a matter "uniquely within the skill and training of the physician." No one disputes that the PA appropriately ordered tube replacement. The facility was then charged with determining the appropriate means by which to carry out that order, and, if additional orders were required, to return to the PA and obtain those orders. The existence of a physician's order does not presumptively establish that facility staff met nursing standards when it attempted to implement that order. See Cross Creek Health Care Center, DAB No. 1665, at 11-12 (1998) where an appellate panel noted that a doctor's order is a prerequisite for imposing a restraint, but the existence of a doctor's order does not presumptively establish that the facility is complying with other requirements for administration of a restraint.

3. Petitioner has not demonstrated that section 7510 of the State Operations Manual applies to this situation.

In its post-hearing brief, Petitioner cites section 7510 the State Operations Manual and argues that its deficiency does not meet the level of egregiousness sufficient to justify imposing a CMP for an instance of past noncompliance. CMS objects that this issue has not been timely raised. I do not reach that somewhat thorny issue because I conclude that section 7510 does not apply here, and, even if it did and the issue had been timely raised, I consider the deficiency egregious.

Section 7510 provides that -

if the facility has been out of compliance with a regulatory requirement between two surveys which found it in compliance, the past noncompliance should not be cited by the survey team if a quality assurance program is in place and has corrected the noncompliance. An exception to this policy should be made in cases of egregious noncompliance, such as when the noncompliance has caused the death of a resident.

This record contains no evidence as to the facility's standard compliance surveys. Presumably, because it was certified, the facility was found in compliance at the standard compliance survey immediately preceding the May complaint investigation. However, I have no evidence that this deficiency, found in May 2000, occurred between two standard surveys, both finding the facility in substantial compliance. Nor has Petitioner presented evidence of a quality assurance program implemented to correct that instance of noncompliance. I therefore find the provision not applicable to this case. ⁽¹⁸⁾

4. The amount of CMP imposed against Petitioner, $10,000, is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). Emerald Oaks at 10; CarePlex of Silver Spring, DAB No. 1683, at 13-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). My "inquiry should be 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 in light of the other factors involved." CarePlex at 8.

The CMP imposed against Petitioner, $10,000, is the maximum CMP for an instance of noncompliance. ⁽¹⁹⁾ Although, in its hearing request, Petitioner raised the issue as to the appropriateness of the penalties imposed, the parties did not address that issue in their submissions. I am required to consider evidence properly before me concerning the 488.438(f) factors, but CMS does not have to offer evidence as to those factors as part of its prima facie case.

Rather, if a facility contends that its financial condition or some other factor makes a CMP unreasonable, then the facility must raise that contention on a timely basis before any question would arise as to CMS's responsibility for producing evidence as to that factor.

Community Nursing Home at 22. The record is silent as to the facility's compliance history and financial condition. However, the deficiency was serious, and the facility culpable. I am, therefore, not able to find CMS's determination unreasonable.

VII. Conclusion

For the reasons discussed above, I uphold CMS's determination that on January 21 through 22, 2000, the facility was not in substantial compliance with program participation requirements because its actions in replacing a PEG tube did not meet professional standards of quality as required by 42 C.F.R. � 483.20(k)(3)(i). The amount of the CMP imposed - $10,000 - is reasonable.

Carolyn Cozad Hughes

Administrative Law Judge

1. At the close of the hearing, Petitioner asked leave to amend its witness list to add an additional witness. CMS strenuously objected. In a ruling dated July 6, 2001, I denied Petitioner's motion. Citing the Civil Remedies Division Procedures, I determined that Petitioner had not demonstrated "extraordinary circumstances (such as surprise or rebuttal)," nor "lack of substantial prejudice to the objecting party" to justify adding an additional witness at such a late date. See Ruling Denying Petitioner's Motion to Further Supplement Witness List (July 6, 2001) .

2. Aspiration pneumonia is inflammation of the lungs caused by inhalation of foreign material. Recurrent aspiration is one of several clinical indications for enteral feedings (administration of nutrients directly into the stomach through a tube). P. Ex. 1, at 3.

3. A number of entries in the nursing notes, dated "11/21/00" between 9 and 10:45 PM, are entered out of sequence following the "11/21/00" 11:00 PM entry. CMS Ex. 10, at 8.

4. Even though the surveyor notes include a subsequent reference to "putting the tube in," I conclude that this describes DON Johnston's subsequent action, rather than additional discussion of the telephone conversation.

5. The nursing notes describing the events from 3 AM and following are rife with cross-outs and alterations of the sans-sans serif that are not initialed or otherwise acknowledged or explained. CMS. Ex. 10, at 9.

6. Auscultation is the procedure for listening to sounds within the body to assess the functioning of an organ or to detect the presence of disease. The sounds are heard through a stethoscope. The parties agree, and the professional journals confirm, that ausculation is an unreliable method of determining tube placement. Tr. from June 27, 2001, at 33 (Johnston testimony: "Air auscultation is not, by itself, worth a whole lot in my opinion.")

7. Curiously, CMS's copy of the nursing notes contains the marginal note "in order to clean," which is missing from Petitioner's copy of the exhibit. Compare CMS Ex. 10, at 9 with P. Ex. 14, at 3.

8. Peritonitis is a bacterial or chemical inflammation of the peritoneal cavity. An article in Nursing99 cautions that even "if your patient has minor signs and symptoms of peritonitis, treat them as an emergency because peritonitis may lead to septic shock." CMS Ex. 19, at 3.

9. The State Operations Manual (SOM) recommends recourse to professional journals as a method of corroborating the accepted clinical practice. SOM Appendix PP, PP-82.4.

10. The text also cautions that checking pH is not failsafe. "[A]lthough pH is a helpful indicator of tube location, additional markers are needed to help differentiate between gastric and intestinal fluids." P. Ex. 2, at 3-4.

11. The transcriber, in error, typed "appropriate and placed in peritoneal tracks" instead of "inappropriately placed in peritoneal tracks." CMS Ex. 5, at 5.

12. Denise Helms, an independent nurse consultant, has a BSN from Mid-America Nazarene College. Her resume indicates that she was a DON for a 130 bed skilled nursing facility for an unspecified period of time, and that she was once responsible for directing the corporate clinical team for 64 facilities.

13. Petitioner submits what appear to be the facility's internal guidelines for enteral feeding. They direct trained staff to verify placement of the tube before feeding, or medication administration by "one of the following:" aspiration of the stomach contents, check the amount and re-insert into the stomach, or air auscultation. P. Ex. 4, at 2. But everyone agrees that air asculation is insufficient, so a procedure that allows staff to rely on that method alone is deficient. The surveyors apparently did not review this written procedure. The procedure says nothing about replacing tubes, and does not distinguish between a new and an old tube. According to PA Corley, when she met with the facility administrator and the DON after the incident, they told her that they had no written procedure on replacement of PEG tubes, so she subsequently found one and provided it to them. Tr. from June 22, 2001, at 41.

14. I do not hold here that testing the gastric return by more reliable means (such as testing pH) would necessarily mean that the facility acted within professional standards of care, given the documented shortcomings of that method. However, had the facility done at least this much, it would have presented a much stronger case that it acted within professional standards of quality.

15. DON Johnston did not appear to recognize the serious risk associated with replacing a newly inserted tube. She testified that she felt "there was no danger of me putting the tube in the wrong place." Tr. from June 27, 2001, at 30.

16. Obviously, discussing the tube replacement with the treater and obtaining a physician signature on the order for tube replacement were appropriate actions. Taken literally, this statement means very little .

17. For example, PA Corley also flatly denied having ordered reinsertion of the PEG tube at the facility, but claimed that she instructed LVN Parker to send him to the emergency room. Tr. from June, 22, 2001, at 16, 28, 29, 30, 35. On the other hand, she admitted later telling DON Johnston that she "had taken all the correct steps when she replaced the tube." Tr. from June, 22, 2001, at 34. Still, she insisted that she did not realize that the patient had not been sent to the emergency room. Tr. from June 22, 2001, at 35.

18. Moreover, here, nursing staff, acting outside the parameters of professional standards of quality, inserted a PEG tube into the resident's peritoneum instead of his stomach. The results were very serious. I would consider this deficiency sufficiently egregious to satisfy the SOM provision.

19. CMS might have been justified in imposing a per day penalty, requiring assurances over time that the deficiency would not be repeated. So, although CMS imposed the maximum per instance CMP, the result was not as harsh as it might have been. See Lake City Extended Care Center, DAB No. 1658, at 14-15 (1998).