Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
IHS at Theron Grainger, |
DATE: June 20, 2002 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-00-606
Decision No. CR922 |
DECISION | |
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:
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.
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:
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:
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. 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:
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.
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.
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
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.
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 -
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.
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.
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 -
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)
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. |
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JUDGE | |
Carolyn Cozad Hughes Administrative Law Judge |
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FOOTNOTES | |
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). | |