Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Life Care Center of Columbia,
(CCN: 42-5337),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-13-367
Decision No. CR4132

Date: August 18, 2015

DECISION

Life Care Center of Columbia (Petitioner or the facility) challenges the determination of
the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial
compliance with Medicare program participation requirements. Petitioner also
challenges the imposition of a civil money penalty (CMP) of $10,000 per day from
October 26, 2012, through November 5, 2012, based on multiple immediate jeopardy
level deficiencies, and a $750 per day CMP from November 6, 2012, through November
8, 2012, for deficiencies below the immediate jeopardy level. For the reasons discussed
below, I affirm CMS’s determination.

I. Background

The Social Security Act (Act) sets forth requirements for a long-term care facility’s
participation in the Medicare program and authorizes the Secretary of Health and Human
Services (the Secretary) to promulgate regulations implementing those statutory
provisions. Act § 1819 (42 U.S.C. § 1395i-3). The Secretary’s regulations are found at
42 C.F R. Parts 483 and 488. To participate in the Medicare program, a facility must
maintain substantial compliance with program requirements. To be in substantial
compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety
than the potential for causing minimal harm.” 42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine
whether skilled nursing facilities (SNFs) are in substantial compliance. Act § 1864(a)
(42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10. The Act also authorizes the Secretary to
impose enforcement remedies against SNFs that do not comply with the federal
participation requirements. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The
regulations specify the enforcement remedies that CMS may impose if a facility is not in
substantial compliance with Medicare requirements. 42 C.F.R. § 488.406. Among other
enforcement remedies, CMS may impose a per-day CMP for the number of days a
facility is not in substantial compliance or a per-instance CMP for each instance of the
facility’s noncompliance. 42 C.F.R. § 488.430(a). A per day CMP, which CMS imposed
in this case, may range from either $50 to $3,000 per day for less serious noncompliance,
or $3,050 to $10,000 per day for more serious noncompliance that poses immediate
jeopardy to the health and safety of residents. 42 C.F.R. § 488.438(a)(2). “Immediate
jeopardy” exists when “the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. § 488.301.

If CMS imposes a CMP based on a noncompliance determination, then the facility may
request a hearing before an Administrative Law Judge to challenge the noncompliance
finding and enforcement remedy. Act §§ 1128(c)(2) (42 U.S.C. § 1320a-7a(c)(2)),
819(h)(2)(B)(ii) (42 U.S.C. § 1395i(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g),

488 .434(a)(2)(viil), 498.3(b)(13).

Petitioner is a SNF located in Columbia, South Carolina, that participates in the Medicare
and Medicaid programs. On October 25, 2012, an individual who, for privacy purposes
will be called Resident 1 (R1), was transferred from a hospital to the facility in order to
receive therapy following hip replacement surgery. R1, an individual with a variety of
health problems, experienced a significant respiratory incident while at the hospital.
Accordingly, R1’s hospital discharge instructions included an order for the SNF to
contact R1’s physician or 911 in the event that RI experienced shortness of breath.
October 25 and most of October 26 passed uneventfully with R1 not experiencing pain or
having signs or symptoms indicative of a medical problem. At some point between

8 p.m. and 9 p.m. on October 26, R1 repeatedly complained of significant pain in her
back to certified nurse assistants (CNA); however, because the only licensed practice
nurse (LPN) on duty in R1’s hall had to assist another resident to be transported to the
hospital, the LPN did not respond to R1’s complaints until approximately 10:30 p.m.
When the LPN left R1 shortly thereafter, R1 appeared well. However, by approximately
10:45 p.m. to 10:50 p.m., Rl complained to a CNA of shortness of breath. The CNA
took R1’s vital signs, which included a minimally normal oxygenation rate of 90% (89%

is considered low). The CNA informed the LPN of this information and the LPN stated
that she did not have any medication available or authorized to administer to R1. The
CNA returned to RI and R1 indicated that she had previously had congestive heart failure
and would call 911 if she did not receive assistance. The CNA did not inform the LPN of
R1’s intention to call 911 if necessary, but told the LPN that R1 had congestive heart
failure and that R1 was gasping for breath. The LPN told the CNA that she did not have
any medication for shortness of breath. The LPN then assisted another resident who
appeared to wander from his room. During the next 30 to 40 minutes, no facility
personnel checked on R1 as her condition worsened. Ultimately, another resident in the
facility called 911 to obtain assistance for R1. Emergency Medical Service (EMS)
personnel arrived and found R1 unconscious and barely breathing. EMS personnel took
charge of R1’s care, which included emergency efforts to stabilize R1. EMS transported
R1 to a hospital where she died on October 27, 2012.

The South Carolina Department of Health and Environmental Control, Division of
Certification (survey agency), completed a complaint survey at Petitioner’s facility on
November 6, 2012. Based on the findings of the November 6, 2012 survey, CMS found
Petitioner was not in substantial compliance with five program deficiencies each cited at
a scope and severity level of “J,” constituting immediate jeopardy to resident health and
safety:

1. 42 CFR. § 483.10(b)(11)(i), F157 (physician notification of significant changes
to resident);

2. 42 CFR. § 483.13(c), F224 (neglect);

3. 42 CFR. § 483.20(k)(3)(i), F281 (professional standards);

4. 42 CFR. § 483.25, F309 (quality of care); and

5. 42 CFR. § 483.75, F490 (administration).
CMS Exs. 1,2. CMS determined that immediate jeopardy was removed on November 6,
2012, but that Petitioner remained out of substantial compliance. By letters dated

November 29, 2012, and April 2, 2013, CMS notified Petitioner that it was imposing the
enforcement remedies of a $10,000 per day CMP from October 26, 2012, through

' Scope and severity levels are used by CMS and state survey agencies when selecting
remedies. The scope and severity level is designated by letters A through L, selected by
CMS or the state agency from the scope and severity matrix published in the State
Operations Manual, chap. 7, § 7400.5 (Sep. 10, 2010). Scope and severity levels J, K, or
L indicate deficiencies that constitute immediate jeopardy to resident health or safety.
November 5, 2012, $750 per day CMP from November 6, 2012, through November 8,
2012, and a withdrawal of approval of Petitioner’s nurse aid training and competency
evaluations program for a period of two years. The total CMP imposed was $112,250.
CMS Ex. 2; P. Ex. 1.

In a January 25, 2013 letter, Petitioner requested a hearing to dispute CMS’s finding that
it was not in substantial compliance with program requirements and the imposition of
remedies. In response, I issued an Acknowledgment and Initial Prehearing Order.

In compliance with my prehearing order, the parties filed written direct testimony for
their proposed witnesses. CMS also filed 15 proposed exhibits, marked as CMS Exs.
1-15, and Petitioner filed 19 proposed exhibits, marked as P. Exs. 1-19. On February 11,
2014, I convened a video hearing; however, due to inclement weather in Columbia, South
Carolina, I had to reconvene the hearing on March 10 and 11, 2014. A transcript (Tr.) of
the proceedings was prepared. At the hearing, I admitted CMS Exs. 1-15 and P. Exs.
1-19 into the record as well as a corrected version of CMS Ex. 6, all without objection
from the parties. Tr. 10, 131. I received testimony from: Robin Lessard, Registered
Nurse (RN), surveyor for the survey agency (CMS Ex. 14); Frederick Rose, LPN,

(P. Ex. 16); Randall Pruette, Petitioner’s Director of Nursing (DON) (P. Ex. 13); William
Crigler, M.D., R1’s physician while at the facility (P. Ex. 18); Shanderlyne Worthy,
CNA, (P. Ex. 17); Kimberly Theuerl, RN, (P. Ex. 15); and Robert Eads, M.D., expert
witness for Petitioner (P. Ex. 19). At the end of the hearing, I permitted CMS to submit
additional exhibits, subject to objection by Petitioner.

CMS filed a post-hearing brief (CMS Br.) and additional proposed exhibits (CMS Exs.
16-21). Petitioner filed a brief in response (P. Br.) and objected to CMS’s newly
proposed exhibits. CMS declined the opportunity to file a reply brief.

II. Evidentiary Rulings

Tadmit CMS Exs. 16, 20, and 21 into the record, but exclude CMS Exs. 17-19. I have
authority to admit additional exhibits after completion of the hearing, but before issuing a
decision. 42 C.F.R. § 498.60(b). The following is my analysis regarding CMS’s
proposed exhibits.

A. Proposed CMS Ex. 16

CMS submitted CMS Ex. 16, a letter from David E. Koon, Jr., M.D. to CMS counsel, to
clarify the handwriting on a patient transfer form submitted as part of P. Ex. 3. Dr. Koon
was the physician who discharged R1 from the hospital following her hip replacement
surgery. In the section entitled Worsening Symptoms (symptoms, action plan, MD
notification), there is a handwritten notation that an unidentified phone number or 911
should be called if R1 has a fever greater than 101.5, chest pain, shortness of breath,
worsening bloody/drainage or any purulence. P. Ex. 3 at 14. Dr. Koon’s letterhead
shows a phone number for his clinic, which is part of the University of South Carolina’s
School of Medicine, Department of Orthopedic Surgery, which is the same as the
unidentified phone number on the transfer patient form. CMS did not object to P. Ex. 3,
and I admitted it into the record at the hearing. Tr. 9-10.

Petitioner objects to CMS Ex. 16 because CMS does not clearly state why this exhibit is
submitted and why it could not have been “produced in the ordinary course.” April 11,
2014 P. Reply to CMS’s Mot. to Offer Additional Exhibits at 3. CMS’s purpose in
submitting this document is to clarify handwriting. April 3, 2014 CMS List of Rebuttal
Exhibits at 1. Further, as P. Ex. 3 is not CMS’s exhibit and Petitioner submitted the
exhibit after CMS filed its exhibits in this case, CMS would necessarily have to submit
this exhibit after the date for the submission of its exhibits passed. Because this
document simply clarifies a statement in an exhibit over which there is no apparent
dispute, I will admit it into the record for the purpose of ensuring clarity of the
handwritten notes at issue on page 14 of P. Ex. 3.

B. Proposed CMS Ex. 17

CMS submitted CMS Ex. 17, a National Institutes of Health article, because it indicates
that “one of the causes of wheezing is heart failure,” which allegedly contradicts
“Petitioner’s witness Dr. Eads [who] testified on cross-examination that wheezing could
not be caused by heart failure.” April 3, 2014 CMS List of Rebuttal Exhibits at 1. CMS
did not specifically cite to the transcript showing this portion of Dr. Eads’ testimony.
Petitioner objected to this exhibit for a variety of reasons, including that it is not timely
and that CMS did not show this article to Dr. Eads. April 11, 2014 P. Reply to CMS’s
Mot. to Offer Additional Exhibits at 4.

l exclude this exhibit. Dr. Eads testified that wheezing cannot cause a heart attack
because it is a symptom. Tr. 458, 472-73. Dr. Eads disputed the emergency room
doctor’s assessment that R1 “had notable wheezing, which is very likely the cause of her
arrest ...” and indicated he did not understand that statement. Tr. 489-90; CMS Ex. 4 at
25. Therefore, the document does not rebut Dr. Ead’s testimony, which is the reason
CMS submitted it.

C. Proposed CMS Exs. 18 and 19.

CMS submitted CMS Exs. 18 and 19 (Statement of Deficiencies) as evidence showing
that Petitioner’s expert witness, Dr. Eads, was the medical director of a different SNF
when that SNF was cited for immediate jeopardy level deficiencies, deficiencies that
specifically implicated the medical director of the facility. CMS contends that these

Statements of Deficiencies are evidence that Dr. Eads was ineffective in ensuring that the
SNF cared for and monitored residents with respiratory problems and pain, issues related
to the present case. April 3, 2014 CMS List of Rebuttal Exhibits at 2.

Petitioner objects to the admission of these exhibits because neither exhibit expressly
identifies Dr. Eads, or specific acts or omissions on his part. Petitioner also believes that
these documents are ambiguous and do not show whether any deficiencies were disputed.
April 11, 2014 P. Reply to CMS’s Mot. to Offer Additional Exhibits at 5-6.

l exclude these exhibits. Petitioner gave notice that Dr. Eads would be a witness before
the hearing and provided written direct testimony and curriculum vitae. P. Ex. 19. CMS
did not object to Dr. Eads as an expert witness or seek to voir dire his credentials at the
hearing. CMS knew very specific information about the dates and deficiencies of the
SNF where Dr. Eads used to serve as medical director (or, according to Dr. Eads, one of
the medical directors) because CMS asked him about it at the hearing; however, Dr. Eads
had no recollection of the deficiencies. Tr. 453-454. CMS had ample opportunity to
have had CMS Exs. 18 and 19 available for the hearing so that CMS could question Dr.
Eads further concerning those documents. CMS did not do so. CMS submits these
documents, which are ambiguous as to Dr. Eads’ exact role in the deficiencies at the
other SNF, too late in this proceeding.

D. Proposed CMS Ex. 20

CMS submitted CMS Ex. 20 in order to provide clarity to the issue in this case
concerning how many times R1 called 911. CMS obtained documents related to the 911
call and the EMS response. CMS stipulates that, contrary to what the information
originally submitted by both parties indicated, there was only one call to 911 and this was
made by R1’s roommate at 11:22 p.m. on October 26, 2012. April 4, 2014 CMS
Memorandum on the Emergency Services Dep’t/911 Records at 1-3. Petitioner concedes
this evidence is relevant to this case and asserts that it always has been Petitioner’s
litigating position that R1 could not have made three 911 calls; however, Petitioner
suggests that I require further authentication of the documents and order that CMS
stipulate that the surveyor in this case incorrectly assumed there were three calls to 911.
April 11,2014 P. Reply to CMS’s Mot. to Offer Additional Exhibits at 6-11.

Iadmit CMS Ex. 20 into the record because it is necessary to clarify the number of calls
to 911. As Petitioner concedes, it is relevant to this case. Further, CMS’s concession in
its memorandum that only one call to 911 was made is sufficient and no other stipulation
is needed. Finally, to the extent Petitioner has attempted to imply the surveyor failed to
investigate this issue, it is worth noting that the record includes information sent to the
South Carolina Office of the Attorney General related to this matter, which included the
following statement: “Columbia Police Department has verified that the resident called
911 at 11:22 pm, 11:36 pm and 11:39 pm.” CMS Ex. 3 at 2; see also Tr. 431. Further,

DON Pruette, who conducted Petitioner’s investigation into R1’s care following her
death, testified that it appeared R1 called 911 three times late on October 26, 2012.

P Ex. 13 at 9-10. Therefore, the admission of CMS Ex. 20 will bring clarity to the issue
as to how many 911 calls were made.

E. Proposed CMS Ex. 21

CMS submitted CMS Ex. 21 in order to show that R1’s roommate had a similar name,
RH, to the individual identified as the 911 caller identified in CMS Ex. 20. Petitioner
points out that this exhibit does not show the individual indicated was the roommate of
R1 on the dates relevant to this case. However, this document, along with CMS Ex. 20,
shows that RH, a resident at the facility, is likely the 911 caller. Because Petitioner does
not assert that its personnel called 911, this exhibit is useful to clarify that a resident
called 911. Therefore, I admit CMS Ex. 21 it into the record.

III. Issues
The issues presented are:

1. Whether Petitioner failed to be in substantial compliance with the Medicare
participation requirements.

2. Ifso, whether CMS’s determination of noncompliance at the immediate
jeopardy level is clearly erroneous; and

3. Whether the CMP amount that CMS imposed is reasonable.
IV. Findings of Fact

The November 2012 complaint survey stems from the events that occurred on October
26, 2012, pertaining to RI.

Prior to October 26, 2012, R1 had diagnoses including diabetes, obesity, chronic
obstructive pulmonary disease (COPD), anemia, osteoarthritis, diastolic congestive heart
failure, chronic kidney disease, coronary artery disease, and hypertension. She had a
previous coronary artery bypass and received stenting to her vein. P. Ex. 3 at 4,6. On
October 18, 2012, R1 had surgery, a left total hip arthroplasty, which was uneventful.

P. Ex. 3 at 1. Prior to her surgery she had been cleared for surgery by her cardiologist.
P. Ex. 3 at 6. Following the surgery, hospital records note two “Rapid Response” actions
on October 19 and 20, 2012 that may have been due to over sedation from Oxycontin.

P. Ex. 3 at 8, 10.
On October 25, R1 was transferred to Petitioner’s facility for rehabilitation. In the
October 25, 2012 Transfer Summary from the hospital, R1’s attending physician, Dr.
Koon, states that R1 had developed “some acute respiratory failure” during her hospital
stay, was weaned from her intravenous pain medications without difficulty, and could
take pain medications as dictated by her primary care physician at the healthcare facility.
P. Ex. 3 at 1. The last pulse oxygen reading taken in the hospital was 98%. CMS Ex. 3
at 8, 10. The October 25, 2012 Discharge Instructions from the hospital state under the
heading “WORSENING SYMPTOMS” to call a telephone number for Dr. Koon or 911
for chest pain or shortness of breath, among other things. P. Ex. 3 at 14; CMS Ex. 16.
Petitioner’s October 25, 2012 intake form indicates that R1 had regular and clear lung
sounds with blood pressure at 140/60, pulse at 86, and respiration at 18. CMS Ex. 4 at 1;
P. Ex. 4 at 1. Petitioner’s October 25, 2012 pain assessment shows that R1 was currently
in pain, at risk for pain, and experienced pain in the past. R1’s past pain was due to
arthritis in her hip and her current pain was assessed as 0, although this is slightly
contradicted by the assessment’s currently in pain indication and a score of “1” indicating
a mild score for facial expression showing pain. P Ex. 5 at 1. It is undisputed that upon
admission to Petitioner’s facility, R1’s pain was, at most, mild.

R1 was being cared for primarily by CNA Worthy and Nurse Kind during the evening of
October 26, 2012. It is undisputed that Nurse Kind, an LPN, was in charge of hall 300
where R1 resided during the evening shift. CMS Ex. 10. It is also undisputed that
October 26, 2012, was Nurse Kind’s first day working on hall 300. P. Ex. 13 at 5. It is
undisputed that a CNA is not qualified or authorized to assess pain or do a lung or
respiratory assessment. The record shows that Nurse Kind saw R1 before she
complained of shortness of breath and no nurse, including Nurse Kind, saw R1 after the
complaint of shortness of breath until after EMS arrived to provide emergency assistance.

The following factual findings, especially those related to the facility’s care of and
response to R1’s complaints of pain and shortness of breath on the evening of October
26, 2012, are primarily taken from the written statements CNA Worthy and Nurse Kind
made during the facility’s prompt investigation following R1’s death. See CMS Ex. 9 at
1-2, 9-10. These individuals provided this information nearly contemporaneously with
the event and were the primary facility actors related to the event. Nurse Kind was not
called by either party as a witness. CNA Worthy testified in this proceeding; however,
her testimony tends to minimize and possibly contradicts the statements she made in her
written statement during the facility’s investigation. See Tr. at 223-260; P. Ex. 17. Ido
not find CNA Worthy’s later testimony to be as credible as her written statements made
very close in time to R1’s death. Further, CNA Worthy is still employed by Petitioner
and thus has an interest in her employer avoiding a negative outcome in this case. P. Ex.
17 at 1. She was more likely to have been accurate in a statement made during the
facility’s internal investigation than during an adversarial sanction proceeding against her
employer. See Beverly Healthcare Lumberton v. Leavitt, 338 Fed. App’x 307, 312-313
(4" Cir. 2009).
When EMS arrived at the facility, other facility employees became involved at that point
and their statements and testimony form the primary evidence for those subsequent

events.

Except as otherwise noted, the findings of fact below refer to events on October 26, 2012.

1.

A progress note by Azella Walker, LPN, indicates that at 12:01 a.m., Tylenol was
administered to R1 and there were no signs or symptoms of respiratory distress.
R1’s pulse was 86, respiration rate was 18 and blood pressure was 140/60. CMS
Ex. 4 at 14; P. Ex. 6 at 5.

. A progress note by Nurse Theuerl indicated that at 4:06 a.m., R1 did not state she

had pain or discomfort. R1’s pulse was 77, respiration rate was 20 and blood
pressure was 133/46. CMS Ex. 4 at 14; P. Ex. 6 at 7.

. A nursing note by Aveal S. Cornelius, RN indicated that at 9:07 a.m., R1 was

sitting up in bed; the note does not mention pain or discomfort. CMS Ex. 4 at 14.

. A progress note by Darlene Reddick, RN stated that at 3:05 p.m., R1 attended

therapy, that there were no signs or symptoms of cardio/respiratory distress, and
that R1 “[d]enies pain/discomfort.” R1’s pulse was 79, respiration rate was 20,
and blood pressure was 133/55. CMS Ex. 4 at 14; P. Ex. 6 at 6. Nurse Reddick
considered R1 to be well during the day. P. Ex. 14 at 2.

. From approximately 6:25 p.m. until 7:15 p.m., R1’s daughter visited R1. R1’s

daughter indicated that R1 spoke to R1’s grandson on the telephone, was sitting
up, and “was well responsive.” CMS Ex. 3 at 8.

At approximately 7:45 p.m., RI asked Nurse Kind about her medications and
Nurse Kind told R1 that R1’s medications had not arrived yet and that a check of
the facility’s Pixus machine for R1’s medications was unsuccessful. Nurse Kind
did not notice R1 having any signs or symptoms of respiratory distress. CMS Ex.
9 at9.

. At some time after 7:45 p.m., following Nurse Kind’s check of the next resident

on the hall, a CNA told Nurse Kind that Rl was complaining of pain. CMS Ex. 9
at 9.

. At the same time that a CNA informed Nurse Kind of R1’s complaint of pain, the

situation for a male resident in room 320 worsened when he showed signs of a
coming stroke. Dr. Crigler, a physician working for the facility, was contacted
and he ordered Nurse Kind to place the resident in room 320 on oxygen, to call
911, and to send him to the hospital. In dealing with oxygen for the resident in
10

room 320, Nurse Kind had significant confusion about where to get oxygen and
expended time walking to various places in the facility. Ultimately, EMS arrived
before Nurse Kind could provide oxygen to the resident in room 320. The resident
in room 320 departed the facility for the hospital prior to Nurse Kind checking
R1’s Medication Administration Record for any pain medications, which occurred
at around 10:30 p.m. CMS Ex. 9 at 9.

9. Nurse Kind stated: “During this whole process [of assisting the resident in room
320], my CNAs kept telling me that [R1] was [complaining of] pain. I repeatedly
told them to let her know that I was in the middle of sending a patient to ER and
that I would be with her as soon as I could get to her.” CMS Ex. 9 at 9.

10.In CNA Worthy’s written statement made during the facility’s investigation of the
events related to R1, she reported that R1 complained of pain and CNA Worthy
and another CNA, Lador Jenkins, reported the pain complaints to Nurse Kind four
or five times on October 26, 2012. According to CNA Worthy’s statement, Nurse
Kind said that R1 did not have any medication for pain. CNA Worthy stated that
R1 was “hollering and she was getting upset”. CMS Ex. 9 at 1.

11. According to Nurse Kind, at about 10:30 p.m., after sending the resident in room
320 to the hospital, she looked up to see if R1 had any medications for pain.
Nurse Kind prepared Tylenol and aspirin, and found R1 sitting on the side of the
bed with her legs dangling over the side. R1 indicated to Nurse Kind that the
CNAs did not tell R1 anything about the emergency in room 320 and that if R1
had known Nurse Kind was dealing with an emergency, she would have been
more patient about obtaining pain medications. Nurse Kind reported that R1 was
alert and oriented without signs and symptoms of respiratory distress or shortness
of breath. CMS Ex. 9 at 10.

12.Nurse Kind began her 9 p.m. medication pass, which was one and one-half hours
late, after she saw R1 at 10:30 p.m. CMS Ex. 9 at 10.

13. Between 10:30 p.m. and 10:50 p.m., according to the state surveyor’s interview of
CNA Worthy, CNA Worthy checked on R1 and R1 stated that Nurse Kind gave
R1 pain medication at approximately 10:30 p.m., but R1 started to complain of
shortness of breath. R1 grabbed her personal inhaler when CNA Worthy lowered
her to lay in bed (nowhere in the record does it indicate that R1 actually used her
inhaler). R1 asked CNA Worthy to inform the nurse of her shortness of breath.
CMS Ex. 6 at 3.
11

14. Nurse Kind stated that, at 10:50 p.m., a CNA informed her that R1 was
experiencing shortness of breath. Nurse Kind asked the CNA to get R1’s vital
signs. Nurse Kind stated that the CNA reported that R1’s vital signs were: blood
pressure 154/75, pulse 100, pulse oxygenation rate 90%, respirations 20, and
temperature 97.2. CMS Ex. 9 at 10; P. Ex. 6 at 1,8: Nurse Kind looked up in the
Medication Administration Record to see if there was any type of aerosol or
nebulizer, but she did not notice an order for either. CMS Ex 9 at 10.

15.CNA Worthy’s written statement is consistent with Nurse Kind’s email statement:
“Then [R1] was short of breath and I had got her [vital signs] and [oxygen] stat
and I reported it to the nurse. [Nurse Kind] did not move from the [medication]
cart.” CMS Ex. 9 at 1. When CNA Worthy went back to R1,R1 said “she was
going to call 911 and [that Nurse Kind] did not care about her . . . .” CNA Worthy
further stated: “I went back down to the nurse and inform[ed] her that [R1] has
congestive heart failure and she was gasping for breath . . . .” and [Nurse Kind
looked at R1’s Medication Administration Record and said that she didn’t have
anything for shortness of breath.” CMS Ex. 9 at 1. CNA Worthy testified that she
did not inform Nurse Kind that R1 stated she would call 911. Tr. 241-43. CNA
Worthy also testified that she thought R1 was in distress related to the shortness of
breath. Tr. 243.

16. At this point, Nurse Kind states: “I then went to her chart to check for any type of
treatments. Before I could get to her chart, another patient came out of his room,
303, and appeared confused and unstable. I immediately went to him, to help him
back to his room.” CMS Ex. 9 at 10.

17. At 11:22 p.m., EMS received a 911 call regarding R1. CMS Ex. 20 at 1, 4.

18.RM, a resident at the facility made the call to 911. CMS Ex. 20 at 4, 8; see also
CMS Ex. 21.

19. Between 11:23 p.m. and 11:27 p.m., an EMS unit was dispatched and on its way
to the facility. CMS Ex. 20 at 1, 4.

20.At about 11:30 p.m. the 911 operator called the facility to inquire after the 911 call
concerning R1. Frederick Rose, an LPN on another floor answered the call and
transferred it to the 300 hall where R1 was located. No one on the 300 hall
answered the call. A minute or two later, Nurse Rose answered a second call from
the 911 operator, who informed LPN Rose that R1! was having trouble breathing
and no one was helping her. The 911 operator also stated an ambulance was
dispatched. P. Ex. 16; see also CMS Ex. 20 at 5 (EMS log indicating that at 11:27
p.m., “CALLED LIFE CARE NO ANSWER.”).
12

21.Nurse Rose transferred the 911 operator’s call again to hall 300, and Kimberly
Theuerl, RN, the nurse who had just entered hall 300 to relieve Nurse Kind,
answered the call and said she would check into the matter. P. Ex. 16.

22.Nurse Theuerl, who started her shift at 11:30 p.m., indicated that she received the
call from 911 relayed by Nurse Rose concerning a resident in Room 318. Nurse
Theuerl asked Nurse Kind about the resident in Room 318 and Nurse Kind
responded: “that was already taken care of.” CMS Ex. 9 at 5. Nurse Theuerl
testified that Nurse Kind’s response to the call from 911 was stated in a way that
indicated that she was unconcerned and did not even know there was anything
actively occurring. Tr. 274-276.

23.Nurse Kind’s statement is consistent with Nurse Theuerl. Nurse Kind indicates
that she assisted the patient in room 303 from the time that R1 started to complain
of shortness of breath until the second call from the 911 operator: “While I was
with the patient in room 303, the third shift nurse came on the floor, and answered
the phone. It was 911 wanting to know if a call had been made to 911 stating we
had a patient in respiratory distress. I told the nurse that we had just sent a patient
out about an hour before.” CMS Ex. 9 at 10.

24.The EMS unit arrived at the facility at 11:34 p.m. CMS Ex. 20 at 1, 4; see also
CMS Ex. 9 at 8.

25.The EMS unit sent to assist R1 called the facility requesting that someone open a
door for them. CMS Ex. 9 at 3.

26.CNA Tanisha Anderson had just started her rounds at approximately 11:30 p.m.,
when she answered a call light for room 318 and found R1 unresponsive. She
stated that “I alerted the nurse [Nurse Theuerl] and opened the door for EMS.”
Nurse Theuerl went to Room 318 and EMS personnel, who were already present,
told Nurse Theuerl to get assistance. Nurse Theuerl noticed that R1 was in
respiratory distress. Nurse Theuerl “called a CODE [blue].” CMS Ex. 9 at 4-6;
Tr. 277.

27.The EMS report (CMS Ex. 20 at 1) states:

Found 69 [year old] female sitting on side of bed, head
slumped over, unconscious, pulseless, w/agonal respirations
with cellular phone and inhaler next to her. Facility staff
were unaware that patient had called EMS and unaware of
patient’s state. Patient . . . bagged . . . and chest
compressions initiated (and continued throughout until ER
13

arrival). . . . [Patient] now apneic. Backup called. Staff
finally alerted. Poor chest rise and decreased breath sounds
noted .... Upper airway appears clear, however poor

visibility and thick substance in throat obscuring glidoscope.
Unable to suction on scene. Bagging continued. [Patient]
has very poor vasculature . . . edema to upper and lower
extremities ... . [Patient] 350+ LBS; unable to move
[Patient] until additional assistance arrived. Thumper
applied. 318 arrived as backup. ... [Patient] intubated .. .
tube placement reconfirmed after each [Patient] movement,
and confirmed by physician upon ER arrival. . . . [Patient]
remained asystole until ER arrival.

28.Nurse Kind’s only Progress note for RI concerning October 26 (P. Ex. 6 at 1),
authored on October 27, 2012 at 1:36 a.m., states in relevant part:

At approximately 10:50pm, patient had [complaint of]
difficulty breathing. [Vital signs] checked. BP [blood
pressure] 154/76; Pulse 100; Pulse [oxygenation] 90%;
Resp[iration] 20; Tempferature] 97.2. At approximately
11:30 p.m., patient called 911 with [complaint] of distress.
911 arrived at approximately 11:37 p.m. Within minutes,
resident was unresponsive, and CPR was immediately
initiated. [Doctor], family, and DON were immediately
notified of resident’s status, and orders were given to
transport to [hospital]. Report given to ER nurse.

29.The first time Dr. Crigler was called concerning R1’s condition was when R1 was
being transported to the hospital. Tr. 191.

30.No one from the facility’s staff assessed R1 for her shortness of breath on October
26. Tr. 350.

31.Although the ER reports indicate possible causes of death (possible embolus with
myocardial infarction), the ER physician stated that this was a case for the
coroner. CMS Ex 4 at 33.

32.R1’s death certificate states that the cause of death was: Ischemic
Cardiomyopathy and Cardiovascular Disease. The death certificate indicates an
autopsy was performed and that the Deputy Coroner was the certifier of this
information. CMS Ex. 10 at 1; see also Tr. 492-493.
14

33.Ischemic Cardiomyopathy means that a heart can no longer pump enough blood to

the rest of the body due to coronary artery disease. “Ischemic Cardiomyopatl
a common cause of heart failure.” “Patients with this condition often have

symptoms of angina or a heart attack.” Symptoms include: shortness of breath
that occurs after lying down. P. Ex. 11 at 1. Symptoms of heart attack include
shortness of breath. CMS Ex. 11 at 2. There are many treatments for ischemic

cardiomyopathy, including cardiac catheterization or angioplasty to improve
flow to the damaged or weakened heart. P. Ex. 11 at 2.

V. Conclusions of Law and Analysis

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(b)(

ry is

blood

I@

because Petitioner failed to immediately consult with Resident 1’s physician
when Resident | experienced a significant change in her ability to breath.

The regulation entitled “Resident rights” requires:

(11) Notification of changes. (i) A facility must immediately
inform the resident; consult with the resident’s physician;
and if known, notify the resident’s legal respresentative (sic)
or an interested family member when there is --
(A) An accident involving the resident which results in
injury and has the potential for requiring physician
intervention;
(B) A significant change in the resident’s physical,
mental, or psychosocial status (i.e.,a deterioration in
health, mental, or psychosocial status in either life-
threatening conditions or clinical complications);
(C) A need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse
consequences, or to commence a new form of treatment);
or
(D) A decision to transfer or discharge the resident from
the facility as specified in Sec. 483.12(a).

42 CFR. § 483.10(b)(11)(i) (emphasis added).

It is clear from the regulatory language that the requirement to consult with a resident’s
physician is not discretionary and requires more than merely informing or notifying the

physician. The preamble to the final rule reflects the Secretary’s intention that the

facility should “inform” the resident of the changes that have occurred but must “consult
with the physician about actions that are needed.” 56 Fed. Reg. 48,826, 48,833 (Sept.
26, 1991). Consultation implies the requirement for a dialogue with and a responsive
15

directive from the resident’s physician as to what actions are needed. The use of the term
“immediately” in the regulation indicates that consultation is expected to be done as soon
as the change is detected, without any intervening interval of time. The preamble to the
final rule indicates that originally the proposed rule granted the facility up to 24 hours in
which to consult with the resident’s physician and to notify the legal representative or
family. However, after the receipt of comments stating that time is of the essence in such
circumstances, the final rule amended that provision to require that the physician be
consulted and the legal representative or family be notified immediately. 56 Fed. Reg. at
48,833. The point of using the word “immediately” recognized that in such situations a
delay could result in a situation where a resident is beyond recovery or dies. Consultation
with a physician must occur immediately, that is, without delay, after a significant change
is detected or observed. See Magnolia Estates Skilled Care, DAB No. 2228 at 9 (2009).

CMS argues that prior to the evening of October 26, 2012, R1 was not experiencing pain,
at least not significant pain, had no shortness of breath and did not have a need to call 911
to receive care and services. RN Reddick, the nurse on the 7:30 a.m. to 4:00 p.m. shift,
stated that R1 was in a good mood and there was no sign of distress. CMS Ex. 4 at 14; P.
Ex. 6 at 6. CMS argues that at about 7:30 to 8:00 p.m. on October 26, 2012, R1 started to
complain about pain. CNA Worthy and CNA Jenkins informed Nurse Kind that R1 was
having significant, even severe pain, four or five times, but Nurse Kind did not go to see
R1 until 10:30 p.m. CMS Ex. 9 at 1. In her written statement, CNA Worthy stated that
R1 was “hollering” and “getting upset” and “needed medication real bad.” CMS Ex. 6 at
2; CMS Ex. 9 at 1.2 Nurse Kind gave R1 Tylenol and aspirin at approximately 10:30
p.m., which was about two hours after R1 first started complaining of pain; however,
there is no evidence that Nurse Kind performed an assessment of R1. See CMS Ex. 9 at
9-10; P. Ex. 6 at 1. CMS argues that R1’s pain was “something new,” that R1’s pain
required an assessment, and was a significant change that required physician notification
and consultation. The nursing staff did not consult with Dr. Crigler, the physician
assigned to be R1’s physician while she was at the facility, until after R1’s roommate
called 911 and EMS arrived. Tr. 191.

At about 10:30 p.m. Nurse Kind indicated that R1 was alert and oriented without any
signs and symptoms of respiratory distress or shortness of breath. CMS Ex. 9 at 10. Up
to this point, R1 had not experienced any respiratory distress or shortness of breath
during her stay at the facility. However, between 10:30 and 10:50 p.m., CNA Worthy

> As indicated earlier, CNA Worthy’s testimony in this proceeding minimizes her
observations of R1 on the evening of October 26, 2012. However, I place more weight
on CNA Worthy’s written statement made on October 27, 2012 that was made
contemporaneously with this incident and used descriptors such as “hollering,” “getting
upset,” “gasping for breath” and concluded by stating, “I was really upset cause [sic] the
resident was in so much pain and I did my best to comfort her.” CMS Ex. 9 at 1-2.
16

reports that R1 started to complain of shortness of breath. R1’s complaints of shortness
of breath occurred after the male resident in room 320 suffering a possible stroke was
sent to the hospital. R1 had her inhaler with her but there is no indication that R1 used
her inhaler at that time. CMS Ex. 6 at 3. Nurse Kind was informed of R1’s shortness of
breath but did not go to assess RI. CNA Worthy provided Nurse Kind with R1’s vital
signs but Nurse Kind did not move from the medication cart to assess R1. CNA Worthy
informed Nurse Kind that R1 had congestive heart failure and that she was gasping for
breath. CMS Ex. 9 at 10; CMS Ex. 9 at 1. R1’s pulse oxygen rate had dropped to 90%.
Still, Nurse Kind did not go in to see RI. At 11:22 p.m. 911 was called and EMS arrived
at 11:34p.m. Dr. Crigler, R1’s physician, testified that he received no contact from
anyone at the nursing home about R1 until R1 was transported to hospital. Tr. 191. Dr.
Crigler also testified that only a licensed nurse, not a CNA, is qualified to do an
assessment. Tr. 194.

Petitioner argues that R1’s pain was not significant. Petitioner asserts that some pain was
normal due to R1’s recent hip surgery and the fact that R1 had just started physical
therapy. In addition, R1 was sitting in a wheelchair and moving around more since she
entered the facility. The surveyor, Nurse Lessard, testified that it is reasonable to
anticipate that R1’s pain from her surgery would decrease over time and that an
assessment should be done to determine the cause of R1’s increasing pain. Tr. 144. Both
R1’s severe pain and her shortness of breath were new symptoms and Nurse Kind did not
react to these changes. Whether R1’s pain was significant or whether R1’s pain may or
may not have been related to the respiratory problem later, the failure to administer the
pain medication timely shows the general lack of responsiveness of the facility that
preceded R1 becoming unconscious. I do not address whether R1’s pain is a significant
change because I find, without doubt, that R1’s shortness of breath was a new and
significant change under 42 C.F.R. § 483.10(b)(11)() requiring consultation with a
physician.

Petitioner argues that a pulse oxygen level of 90% is considered within normal limits.
P. Br. at 23. Petitioner claims that shortness of breath with normal vital signs is
consistent for R1 who had COPD, and was agitated, citing Dr. Eads’ testimony.’ Tr. 469-

A pulse oxygen rate of below 90% is considered low and Nurse Theurerl testified that a
drop in the pulse oxygen rate is something that required attention from a nurse. Tr. 289-
90; CMS Ex. 13 at 1. There is no other documentation of a pulse oximeter reading being
taken at the nursing home. Prior to being admitted in the nursing home on October 25,
2012, R1’s lowest oxygen saturation rate in the hospital was 98%. P. Ex. 3 at 8, 10.

* T place little weight on Dr. Eads’ testimony. Dr. Eads was offered as an expert witness
by Petitioner. At the hearing, Dr. Eads did not clearly recall the record he was provided
concerning R1. Tr. 449-453, 458, 459, 479. I found Dr. Eads’ testimony generally
evasive and as such his testimony was not credible. Tr. 442-516.
17

472. In addition, R1 had her inhaler at her bedside which she was holding. CMS Ex. 6 at
3; CMS Ex. 20 at 1. However, an oxygen rate of 90% is at the edge of being considered
low. Petitioner does not account for: R1’s drop in oxygen rate from 98% to 90%, which
should require attention from staff: the report from a CNA that R1 was gasping for
breath; the fact that the inhaler, even if used, was apparently not providing R1 with any
improvement; and the fact that no nurse ever went to check on R1 after she started having
shortness of breath until EMS was already on the scene with an unconscious R1.
Importantly, Petitioner simply overlooks the hospital discharge instructions to call a
doctor or 911 if she experienced shortness of breath which was based on the fact that R1
had “some acute respiratory failure” during her hospital stay. P. Ex. 3 at 1.

Petitioner makes several additional arguments. Petitioner argues that CMS has failed to
make a prima facie case for any violation. Petitioner argues that Nurse Kind was simply
inefficient and waited too long to respond to R1’s complaint that her back was sore and
this by itself would never have resulted in an immediate jeopardy finding if R1 had not
died. Petitioner’s characterization of R1 as having a sore back is not significant to this
decision. I base my decision not on R1’s complaints of pain but primarily on events that
occurred when R1 started to complain about shortness of breath. The essential fact that
the evidence shows is that Nurse Kind saw R1 before she complained of shortness of
breath, but that Nurse Kind never saw R1 after that, even though Nurse Kind was aware
of the shortness of breath and R1’s minimally satisfactory pulse oxygenation rate of 90%.
Indeed, no nurse saw R1 after she started complaining about shortness of breath; instead,
EMS found R1 unconscious before a nurse appeared in R1’s room. I include the events
concerning R1’s complaints of pain to demonstrate Petitioner’s staff lack of response to
R1. Petitioner’s argument about failure to make a prima facie case is unavailing because
the evidence plainly shows that CMS has established a prima facie case. Further, I
conclude that CMS not only has proven that a prima facie case for this violation exists,
but also that a preponderance of the evidence of record shows this as well.

Petitioner asserts that Nurse Kind’s actions were not regulatory violations because of her
“appropriate response to a far more serious emergency the same night.” P. Br. at 6. A
male resident in room 320 was complaining of possible stroke symptoms and Dr. Crigler
ordered that this male resident be sent to the hospital. Petitioner asserts that Nurse Kind
spent a considerable time assessing the male resident, conferring with his physician and
preparing him to send him out to the hospital and that a possible stroke is more serious
than a complaint of a sore back. However, the male resident was sent to the hospital
before 10:30 p.m. CMS Ex. 9 at 9. As a result of sending the male resident to the
hospital, Nurse Kind fell behind in the evening medication pass. Petitioner claims that
nurses must prioritize their duties and actions and here Nurse Kind gave priority to the
emergency situation with the male resident in room 320 and to a time limited medication
pass. The evening shift was very busy for the nurse on duty. Petitioner argues giving
priority to the resident in room 320 was appropriate and that a sore back was normal
considering Resident 1 had nearly three hours of both physical and occupational therapy
18

earlier that day (P. Ex. 8), was recovering from hip surgery, had prolonged bed rest and
was spending time sitting up in a wheelchair.

Petitioner asserts that it is not a regulatory violation that Nurse Kind was very busy on
October 26" and states that CMS did not cite Petitioner for a violation of the staffing
regulation. Petitioner overlooks that the male resident who occupied Nurse Kind’s time
had been sent to the hospital prior to 10:30 p.m., before R1 started to complain about
shortness of breath. Nurse Kind never looked in on R1 in spite of the fact that R1 was
gasping for breath and she had been informed of R1’s shortness of breath by a CNA.
Rather, then check R1, Nurse Kind decided to assist, for a prolonged period, a resident
who appeared confused. CMS Ex. 9 at 10. Nurse Kind, in her statement, did not indicate
that there was any imminent health threat to the confused resident such that she could not
check on R1, who was having trouble breathing. The call to 911 from another resident,
along with the fact that EMS arrived on the scene before a facility nurse, shows that the
facility failed in its duty.

Petitioner argues that R1’s shortness of breath was not a significant change since R1 had
COPD. However, R1’s hospital discharge instructions explicitly warned to call R1’s
hospital attending or “911” if she exhibited shortness of breath. R1 had not had any
shortness of breath since her admittance to the facility until the evening of October 26,
2015. Further, Nurse Kind made no attempt to ascertain why R1 was having shortness of
breath. The inability of R1 to breath properly required consultation with a physician and
there is no dispute that R1’s physician was not consulted about Resident 1’s shortness of
breath.

Petitioner, relying on Dr. Eads opinion, argues that at some point after Nurse Kind
administered Tylenol and before the time the EMS unit found R1 unresponsive, some
ind of significant change occurred that was catastrophic and unrelated to the complaints
of back pain and shortness of breath, and that the facility could not have done anything
about it. P. Ex. 19 at 4. I give little weight to Dr. Eads’ opinion. Had Petitioner’s staff
reviewed R1’s chart, and consulted Dr. Crigler at 10:50 p.m. or contacted 911 promptly,
it is possible that R1 could have received necessary treatment. See P. Ex. 11 at 2.

RI was experiencing severe pain and shortness of breath, both of which are symptoms of
possible medical emergencies such as pulmonary embolism and heart attack. R1 was at
risk from both of these conditions due to her bed rest, recent hip surgery, history of heart
disease, obesity, diabetes, high blood pressure and her age. Tr. 179, 180, 213-14, 323,
320. R1 repeatedly asked for assistance from the nursing staff but the nursing staff failed
to respond to R1. [also believe it is significant that Nurse Kind indicated to other facility
employees that her actions were culpable. LPN La Tasha Nickerson, who responded to
the code blue call for R1, heard Nurse Kind state that she “would probably lose her job
and license over what happened.” CMS Ex. 9 at 3. Further, on October 29, 2012 during
19

DON Pruette’s investigative interview, Nurse Kind stated: “I quit, I’m turning in my
nursing license.” CMS Ex. 9 at 11.

The record is clear that the nursing staff failed to timely assess R1 and failed to
immediately consult with her physician when she had a significant change in her
condition.

2. Petitioner was not is substantial compliance with 42 C.F.R. § 483.13(c)
because Petitioner failed to provide services necessary to avoid physical harm
toR1.

Section 1819(c)(1)(A)(ii) of the Act requires that a SNF protect its residents and promote
their “right to be free from physical or mental abuse, corporal punishment, involuntary
seclusion, and any physical or chemical restraints imposed for purposes of discipline or
convenience and not required to treat the resident’s medical symptoms.” The Act does
not specifically address neglect. However, the Secretary requires that a facility must
develop and implement written policies and procedures prohibiting mistreatment,
neglect, and abuse of residents and the misappropriation of residents’ property.

42 CFR. § 483.13(c).

Neglect is defined in the regulations as “failure to provide goods and services necessary
to avoid physical harm, mental anguish, or mental illness.” 42 C.F.R. § 488.301. The
regulatory definition of “neglect” includes two elements: (1) any “failure to provide
goods and services” and (2) the goods and service are “necessary to avoid physical harm,
mental anguish, or mental illness.” 42 C.F.R. § 488.301. The definition of neglect does
not include an element of knowledge or notice, and the definition of neglect may be
satisfied whether or not staff was aware that the resident was in need of goods and
services to avoid physical harm, mental anguish, or mental illness. The definition of
neglect does not consider the intent of Petitioner’s staff. Neglect may occur even if the
failure to deliver necessary goods and services was unintended. Under a strict application
of the definition of neglect, neglect is complete the instant that staff fails to deliver care
or services necessary to avoid physical harm, mental anguish, or mental illness. The
definition of neglect does not specifically permit a period for a facility to assess and
intervene to meet the need for goods and services. However, SNFs are generally not
treated as being “strictly liable” for violations of statutory and regulatory requirements
for participation. See, e.g., Tri-County Extended Care Ctr., DAB No. 1936, at 7 (2004),
aff'd, Tri-County Extended Care Ctr. v. Leavitt, No. 04-04199 (6th Cir. Dec. 14, 2005);
Cherrywood Nursing & Living Ctr., DAB No. 1845 (2002).

A limited number of defenses have been recognized for specific noncompliance, such as
unavoidability, unforeseeability, and reasonableness. SNFs are not subject to
enforcement remedies for unavoidable negative outcomes, or unforeseen or
unpreventable circumstances that produce a risk for or an actual negative outcome. Tri-
20

County Extended Care Ctr., DAB No. 1936, at 7; Woodstock Care Ctr., DAB No. 1726,
at 21,25, 40. Furthermore, not all regulatory or statutory violations, including instances
of neglect, are subject to the imposition of enforcement remedies by CMS.
Noncompliance occurs and CMS is authorized to impose an enforcement remedy, only if
a statutory or regulatory violation poses a risk for more than minimal harm. 42 C.F.R.
§§ 488.301, 488.402(b).

CMS argues that because of R1’s severe pain and her shortness of breath, R1 was in need
of goods and services, i.e., assessing her condition, consultation with a physician,
treatment or care, and monitoring, none of which were timely received. Surveyor
Lessard, a registered nurse, testified that Nurse Kind should have assessed R1 after she
complained of severe pain and shortness of breath. CMS Ex. 14 at §§16, 19, 20.

In regard to R1’s complaint of shortness of breath on October 26, the only action taken
by the facility staff was to take R1’s vital signs. CMS Ex. 9 at 1-2, 10; P. Ex. 6 at 1.
Staff did not assess R1 for her shortness of breath (Tr. 350) even though shortness of
breath could be a symptom for a serious medical problem (see Tr. 180-181, 345), R1 was
at risk for several serious medical conditions and, importantly, the hospital transfer order
specifically listed shortness of breath as a reason to contact R1’s physician or 911. P. Ex.
3 at 14; Tr. 179, 180, 213-14, 323, 320. Yet, the facility staff did not provide R1 with an
assessment and any additional care that she needed, even if this was limited to calling 911
to obtain care from a hospital.

Petitioner’s policy concerning neglect is identified as P. Ex. 12. Although Petitioner’s
anti-neglect policy is not very specific, Petitioner’s policy defines neglect as “the failure
to provide goods and services necessary to avoid physical harm, mental anguish or
mental illness.” P. Ex. 12 at 35. Petitioner’s neglect policy gives examples of ways in
which staff may either intentionally or unintentionally cause harm to residents including:

Not responding to a resident who frequently rings the call bell because
“they do it all the time.”

Telling a resident you will come back in a minute to provide care

and then not return.

P. Ex. 12 at 34. Here, Petitioner’s staff did not implement its policy on neglect and failed
to provide goods and services necessary to avoid physical harm, mental anguish, or
mental illness in violation of 42 C.F.R. § 488.301 and in violation of its own policy on
neglect.

Although the situation in this case pertained to a single resident and primarily two or
three facility employees, I believe that the record is sufficient for me to conclude that a
violation of 42 C.F.R. § 488.13(c) occurred because Petitioner failed to implement its
policies regarding neglect. As stated in one case:
21

Section 483.13(c) “addresses a deficiency related to lack of
an effective policy as opposed to one directed at the
occurrence of neglect itself.” Emerald Oaks, DAB No. 1800
at 12 (2001). However, the drafters of the regulation
characterized as “inherent in [section] 483.13(c)” the
requirement that “each resident should be free from neglect as
well as other forms of mistreatment,” 59 Fed. Reg. 56,130
(Nov. 10, 1994). The regulation requires that the facility
“implement” its anti-neglect policies. 42 C.F.R. § 483.13(c).
Implementing a policy requires more than drafting and
maintaining documents. Staff must carry out and follow the
policy.

Hanover Hill Health Care Ctr., DAB CR3745, at 5 (2015). Therefore, I conclude that
Petitioner failed to implement its policy concerning neglect when it failed to provide R1
with the services “necessary to avoid physical harm, mental anguish, or mental illness” in
violation of 42 C.F.R. § 488.301 and its own anti-neglect policy.

3. Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(k)(3)(i)
because Petitioner did not meet professional standards of quality in relation
to the care provided to R1.

The regulations require that:
The services provided or arranged by the facility must -
(i) Meet professional standards of quality... .

42 CFR. § 483.20(k)(3)(i).

Professional standards of quality means that services are provided in accordance with
accepted standards of clinical practice which may be determined based on a number of
suggested sources.

Nurse Kind was assigned to care for Rl. CMS asserts that Nurse Kind’s care of R1 fell
short of professional standards of quality and no one else at the facility provided care that
complied with the professional standards of quality. Surveyor Lessard, a registered
nurse, testified that Nurse Kind should have assessed R1 after she complained of severe
pain and shortness of breath. CMS Ex. 14 at §§ 16, 19,20. Petitioner’s witness, Nurse
Theuer!l testified that a timely assessment of R1’s pain should have been done. Tr. 284.
Nurse Theuerl agreed that waiting more than two hours to receive pain medication is not
timely. Nurse Theuerl also testified that an assessment for shortness of breath would
22

include listening to the resident’s lungs. Tr. 286-87. Petitioner’s witness, Nurse Rose
testified that he would have assessed R1 if he knew that Nurse Kind was too busy to do
so herself. He would have assessed both R1’s pain and her shortness of breath. Tr. 210-
12. No one at the facility listened to R1’s lungs or did any kind of assessment of her
shortness of breath.

Nurse La Tasha Nickerson told DON Pruette that she had concerns about Nurse Kind’s
care of R1 and DON Pruette reported these concerns to the state officials as possible
abuse. Tr. at 328. Petitioner’s policies and procedures state that an assessment should be
done with each new report of pain and that the facility is responsible to provide each
resident with aggressive pain treatment. CMS Ex. 15 at 4, 6.

DON Pruette testified that he would have assessed R1, and depending on what the
assessment revealed would have “taken some action including calling the physician,
garner a crash cart, being prepared for something . . . 1 would have auscultated her lungs
[listen with a stethoscope to her lungs] . . . checked her positioning, her breathing, rate,
depth, oxygen saturation, vital signs.” Tr. 433-34. DON Pruette agreed that nursing staff
should have responded immediately to R1 after 911 was called. Tr. 350-51.

Even Petitioner’s expert witness, Dr. Eads, testified that one cannot really determine the
seriousness of a resident’s shortness of breath without an assessment, including listening
to the resident’s lungs observing the resident, asking the resident how she feels and
checking her oxygen levels. Tr. 511-513. Additionally, Dr. Eads’ testimony never
addressed Nurse Kind’s response to the 911 operator’s call.

Nurse Kind indicated that she had already taken care of the situation when 911 inquired
about R1 without even actually seeing R1, let alone assessing her. Dr. Crigler, R1’s
treating physician, testified that someone should assess a resident before answering a
question from 911 concerning a resident who called 911 for assistance.” Tr. at 194. At
another point in his testimony, Dr. Crigler indicated that an assessment should include a
visual examination of the patient if there is difficulty breathing. Tr. 200. Dr. Crigler also
testified that a licensed nurse, not a CNA, is qualified to do an assessment. Id. Nurse
Theuer] testified that she would expect Nurse Kind to go to R1’s room to see if she was
okay when answering an inquiry from 911. Tr. at 276. Nurse Theuer! also testified that a
thorough assessment should be done before responding to 911. Tr. 295. Nurse Rose
testified that he would assess a resident quickly whenever 911 was called to see if there
was a medical emergency. Tr. 214-15. Dr. Crigler also testified that he would expect a
nurse to know who they are caring for or that they were speaking about the right resident.
Tr. 195-96. Instead, Nurse Kind assured 911 that the resident was fine and never

> Dr. Crigler’s testimony was straightforward and not at all evasive, in contrast to Dr.
Eads’ testimony. I place more weight on Dr. Crigler’s testimony than I do on Dr. Eads’
testimony.
23

assessed the resident which clearly did not comply with professional standards of care in
violation of 42 C.F.R. § 483.20(k)(3)(i).

4. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 because
Petitioner provided insufficient quality of care toR1.

The regulations at 42 C.F.R. § 483.25 require that “[e]ach resident must receive and the
facility must provide the necessary care and services to attain or maintain the highest
practicable physical . . . well-being, in accordance with the comprehensive assessment
and plan of care.” In this case, CMS determined that Petitioner failed to substantially
comply with that requirement of 42 C.F.R. § 483.25.

In Woodstock Care Center, DAB No. 1726, at 25 (2000), quoting 54 Federal Register at
5,332, the Board said:

We recognize that a facility cannot ensure that the treatment
and services will result in a positive outcome since outcomes
can depend on many factors, including a_ resident’s
cooperation (i.e., the right to refuse treatment), and disease
processes. However, we believe that it is reasonable to
require the facility to ensure that ‘treatment and services’ are
provided, since the basic purpose for the residents being in
the facility is for the ‘treatment and services’ and that is why
the Medicare or Medicaid program makes payment on the
residents’ behalf. We also think it is reasonable to require the
facility to ensure that the resident does not deteriorate within
the confines of a resident’s right to refuse treatment and
within the confines of recognized pathology and the normal
aging process.

CMS determined that R1 needed a licensed nurse to assess her pain and shortness of
breath in a timely and complete manner and needed the nursing staff to consult with her
physician so that the staff could address her pain and shortness of breath.

Although I do not base my decision on R1’s complaints of pain, I note that Dr. Crigler
testified that complaints of pain should be responded to promptly because pain can
increase blood pressure and heartbeat. Tr. 182-184. Pain is obviously an indication that
something is seriously wrong and can be a symptom of a heart attack.

As I have discussed, I base my decision on the issue of R1’s shortness of breath.
Petitioner had suffered some acute respiratory problems while at the hospital. The
hospital discharge summary indicated that if R1 experienced shortness of breath the
facility should contact her doctor or call 911. P. Ex. 3 at 13. R1 was reported to be
24

gasping for breath. No licensed nurse paid any attention to R1’s complaints of shortness
of breath since 10:50 p.m. Because no qualified staff at the facility was paying attention
to her shortness of breath, another resident at the facility had to call 911. R1 told CNA
Worthy that she was going to call 911 but CNA Worthy did not alert a nurse. The call to
911 occurred at 11:22 p.m. and the EMS team arrived at 11:34 p.m. and found RI
unconscious. For that period of 44 minutes, RI received no care or services from the
nursing home even though she was in a grave medical condition of which they were on
notice. As already discussed, Petitioner failed to provide R1 with the necessary care and
services she required.

5. Petitioner was not in substantial compliance with 42 C.F.R. § 483.75.
The regulation at 42 C.F.R. § 483.75 provides that:

A facility must be administered in a manner that enables it to
use its resources effectively and efficiently to attain or
maintain the highest practicable physical, mental, and
psychosocial well-being of each resident.

The regulation also includes specific requirements with federal, state, and local laws and
professional standards and in other areas, including licensure, training, registry
verification, in-service education, staff qualifications, provision of laboratory, radiology
and other diagnostic services, and clinical records. 42 C.F.R. § 483.75(a)-(p). The
language of section 483.75 is such that any failure of management which adversely
affects a resident constitutes a violation. Further, any violation of federal or state law or
professional standards constitutes a violation of section 483.75(b).

As stated in one case:

The administrative deficiency [at 42 C.F.R. § 483.75] is a
derivative deficiency based on findings of other deficiencies .
. . where a facility has been shown to be so out of compliance
with program requirements that its residents have been placed
in immediate jeopardy, the facility was not administered in a
manner that used its resources effectively to attain the highest
practicable physical, mental, and psychosocial well-being of
each resident.

Asbury Ctr. at Johnson City, DAB No. 1815, at 11 (2002); see also Odd Fellow &
Rebekah Health Care Facility, DAB No. 1839 (2002).

The evidence demonstrates that Petitioner failed to ensure that Nurse Kind would provide
appropriate care to R1 and that Nurse Kind would seek out another nurse either at the
25

facility or on-call if she was overwhelmed or needed to perform some nursing function
that she was not qualified or too busy to do. Not only did Nurse Kind not care for R1 but
Nurse Kind was still doing the 9:00 p.m. medication pass at 11:30 p.m. Tr. 297. Further,
Petitioner also failed to ensure that CNAs would know what to do in a situation where a
nurse was unresponsive to requests for care or would know how to handle a statement by
a resident that the resident was going to call 911. Petitioner failed to ensure that CNAs
would report a resident planning to call 911 to the nursing staff so that the nursing staff
could respond to the resident. Petitioner failed to ensure that the nursing staff would
actually lay eyes on any resident about which the 911 operator called.

Petitioner argues that Nurse Kind could not have done a respiratory assessment because
she is an LPN and under North Carolina law only a registered nurse can do a respiratory
assessment. Tr. 530-31. Petitioner’s argument is meritless and only points to another
failure by Petitioner’s administration--Petitioner failed to have a registered nurse
available to do a respiratory assessment, if needed, as there was no registered nurse on
duty during the 3:00 p.m. to 11:00 p.m. shift (Tr. 532) and Nurse Kind did not even go
into see R1 for any sort of assessment. Further, in the absence of such a registered nurse,
Petitioner ought to have ensured that LPNs prompted contacted a physician regarding a
significant change in conditions.

Any failure of management that adversely affects a resident constitutes a violation of
section 483.75. I have found that Petitioner violated the Medicare participation
requirements at sections 483.10(b)(11)(i), 483.13(c), 483.20(k)(3)(i), and 483.25, and
that these violations posed immediate jeopardy. The same evidence that supports these
deficiency findings also supports my conclusion that Petitioner failed to comply with the
administration requirement.

6. CMS’s determination that Petitioner’s deficiencies posed immediate jeopardy
was not clearly erroneous.

Immediate jeopardy exists when a facility’s noncompliance “has caused, or is likely to
cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.
CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld
unless the facility shows that the determination is clearly erroneous. 42 C.F.R.

§ 498 .60(c)(2); see also Beverly Health Care Lumberton, DAB No. 2156, at 4 (2008),
citing Woodstock Care Ctr., DAB No. 1726, at 39 (2000), aff'd, Woodstock Care Ctr. v.
Thompson, 363 F.3d 583 (6" Cir. 2003). The “clearly erroneous” standard means that
CMS’s immediate jeopardy determination is presumed to be correct, and the burden of
proving the determination clearly erroneous is a heavy one. See, e.g., Owensboro Place
& Rehab. Ctr., DAB No. 2397, at 9 (2001), citing Azalea Court, DAB No. 2352, at 16-17
(2010), aff'd, Azalea Court v. HHS, 2012 WL 2913808 (11th Cir. July 18, 2012).
26

In the present case, CMS alleges that Petitioner’s violations amounted to a scope and
severity level of “J,” constituting immediate jeopardy to resident health and safety. As
indicated above, the record establishes that the violations occurred. A review of the
record also shows that CMS’s immediate jeopardy determination was not clearly
erroneous. Immediate jeopardy does not require actual harm but, as the regulatory
definition indicates, only a likelihood of serious harm. Dumas Nursing & Rehab., L-P.,
DAB No. 2347, at 19 (2010), citing Life Care Ctr. of Tullahoma, DAB No. 2304, at 58
(2010), aff'd, Life Care Ctr. of Tullahoma v. Sebelius, No. 10-3465 (6th Cir., Dec. 16,
2011).

R1 was at an increased risk of heart attack and pulmonary embolism. Petitioner’s own
witnesses, Dr. Eads, Dr. Crigler, Nurse Rose, Nurse Pruette and Nurse Theuerl, all agreed
that R1 was at risk for and/or could have been having a heart attack or a pulmonary
embolism on October 26. Tr. 179, 180, 213-14, 290, 320, 323, 455, 465. R1 never
received an assessment for her severe pain. She never received an assessment for her
shortness of breath. Her treating physician was never contacted. She suffered pain for
about two and one half hours before receiving any pain medication and even when she
received medication there is no evidence that an assessment was made. Petitioner’s staff
was not responsive to R1’s pain. This lack of response carried over to R1’s shortness of
breath. As I already discussed, shortness of breath was a new significant change and the
staff continued not to respond to R1. Neither Nurse Kind nor any other nurse ever saw or
assessed R1’s shortness of breath from 10:50 p.m. until the EMS team found R1
unconscious sometime after 11:30 p.m. R1’s oxygenation level dropped to 90%, a
change from her previous level of 98%. The hospital discharge instructions indicated that
the facility should call R1’s doctor or 911 for shortness of breath. R1 was gasping for
breath. R1 never threatened to call 911 during the several hour wait for her pain
medication. But R1 was so concerned about her shortness of breath and stated she would
call 911 within a short time of starting to have shortness of breath. DON Pruette
testified: “If [R1] was at home, certainly she would call 911 or the doctor’s office. In the
nursing facility she would have a nurse there that hopefully she would rely on for an
assessment to start with.” Tr. 319. Petitioner failed to give R1 a nurse she could rely on,
and without an assessment, no treatment was provided to R1. No nurse even saw R1
from 10:50 p.m., until EMS arrived on the scene. Petitioner’s expert witness, Dr. Eads,
testified that one cannot really determine the seriousness of a resident’s shortness of
breath without an assessment, including listening to the resident’s lungs observing the
resident, asking the resident how she feels and checking her oxygen levels. Tr. 511-513.

Facility personnel did not even call 911, leaving that instead for another resident at the
facility to do, which surely caused a delay in medical assistance reaching R1. Dr. Crigler
testified that a patient might survive a heart attack or respiratory distress if given prompt
appropriate care. Tr. 191. Petitioner’s staff was unresponsive to R1 until the EMS team
found R1 unconscious and took steps to treat her by giving her oxygen, suctioning her
airways, and starting CPR. The basic purpose for residents being in a facility is for care,

27

treatment, and services and that is why the Medicare or Medicaid program makes
payment on the residents’ behalf. Here, the facility failed in its basic purpose. CNA
Worthy knew about R1’s intention to call 911, failed to inform any nurse of R1’s
intention to call 911, and in any event, Nurse Kind was obligated to respond to R1’s
complaint of a serious symptom, such as being unable to breathe properly. The chances
for survival increase if there is prompt appropriate care. CMS has clearly shown that
Petitioner’s failures were likely to result in serious harm and injury to R1.

7. CMS’s determinations concerning the amount and duration of the CMP are
reasonable.

In determining whether the CMP amount imposed here is reasonable, I apply the factors
listed in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3). These factors include: (1)
the facility’s history of compliance; (2) the facility’s financial condition; (3) the factors
specified at 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. The factors at 42 C.F.R. § 488.404
include: (1) the scope and severity of the deficiency; (2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior
history of noncompliance in general and specifically with reference to the cited
deficiencies.

Here, Petitioner has not challenged the reasonableness of the CMP amount imposed in its
pre or post hearing briefs, but does challenge the reasonableness of the penalty amount in
its hearing request. Petitioner has not argued its inability to pay the CMP and, unless a
facility contends that a particular regulatory factor does not support the CMP amount, an
Administrative Law Judge must sustain it. Coquina Ctr., DAB No. 1860 (2002). The
five deficiencies cited here are extremely serious, constituting immediate jeopardy.
Petitioner demonstrated neglect. Nurse Kind failed to respond to R1’s repeated
complaints, failed to assess R1, and failed to consult with the resident’s physician. The
CNA failed to seek out another nurse when it became apparent that Nurse Kind was not
responding the R1’s needs. The CNA failed to let any nurse know that R1 was going to
call 911. No nurse ever looked in on R1 when the 911 operator called inquiring about
R1. The nursing home did not train Nurse Kind to seek assistance when she was
overwhelmed, to call in a registered nurse who would be able to do a proper respiratory
assessment, or to contact a resident’s physician when a significant change occurred. RI
died shortly after she was transported to the hospital. Had R1 received prompt competent
care from the nursing staff the result might have been different. Petitioner’s staff did not
check R1, which ultimately necessitated that a resident call 911 due to its complete lack
of response to R1’s needs. These failures were systemic. Petitioner’s noncompliance
was egregious and supports the high CMP amount imposed.

28

Petitioner questions why the immediate jeopardy persisted for days after Nurse Kind
resigned her position. Petitioner trained CNAs on reporting resident’s change in
condition to the charge nurse from October 29 through November 6, 2012. All facility
nurses received education on the facility’s policies and procedures regarding the
reporting of residents change in condition and physical assessments from October 29
through November 6, 2012. The finding of immediate jeopardy was lifted on November
6, 2012, consistent with the dates training was completed. I find that the duration of the
immediate jeopardy was appropriate.

Accordingly, I conclude that the CMP imposed in this case is reasonable. Further, in this
case, the state is required by law to withdraw any approval given, or to deny any approval
sought, by Petitioner to conduct a nurse aid training and competency evaluations program
for a period of two years. See 42 C.F.R. § 483.151(b)(2), (e)(1).

VI. Conclusion

I conclude that Petitioner was not in substantial compliance with five deficiencies cited
by CMS. Further, I conclude that CMS’s determination that each of those violations
posed immediate jeopardy was not clearly erroneous. Finally, I conclude that the CMP
amount CMS imposed was reasonable.

/s/
Scott Anderson
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Donovan C. James, M.D.,
(OI File No. H-13-4-2607-9),

Petitioner,
v.

The Inspector General.

Docket No. C-15-1841

Decision No. CR4127

Date: August 17, 2015
DECISION

The Inspector General (IG) of the United States Department of Health and Human
Services excluded Petitioner, Donovan C. James, M.D., from participation in Medicare,
Medicaid, and all other federal health care programs pursuant to 42 U.S.C. § 1320a-
7(b)(4), effective February 19,2015. Petitioner requested a hearing to dispute the
exclusion. As explained below, I conclude that the IG had a basis for excluding
Petitioner from participation in federal health care programs because Petitioner
voluntarily surrendered his Colorado medical license while a formal disciplinary
proceeding was pending before the Colorado Medical Board (Medical Board) for reasons
bearing on his professional competence or professional performance. The exclusion must
last until Petitioner regains his license. 42 U.S.C. § 1320a-7(c)(3)(E).

I. Background

By letter dated January 30, 2015, the IG notified Petitioner that he was being excluded
from Medicare, Medicaid, and all federal health care programs pursuant to 42 U.S.C.

§ 1320a-7(b)(4) until he regains his license as a physician in Colorado and the IG
reinstates him. The IG advised Petitioner that the exclusion was based on the revocation,
suspension, loss, or surrender of his license to provide health care as a physician while a
formal disciplinary proceeding was pending before the Medical Board for reasons
bearing on his professional competence, professional performance, or financial integrity.
IG Exhibit (Ex.) 1.

Petitioner timely requested a hearing to dispute the exclusion. On May 6, 2015, I
convened a prehearing conference by telephone, the substance of which is summarized in
my Order and Schedule for Filing Briefs and Documentary Evidence (Order) of May 7,
2015. See 42 C.F.R. § 1005.6. Pursuant to the Order, the IG submitted the IG’s brief (IG
Br.) along with seven exhibits (IG Exs. 1-7). Petitioner submitted an informal brief in
response (P. Informal Br.), a brief (P. Brief), and eight exhibits designated as Exs. A-H.
The IG. filed a reply brief (IG Reply).

II. Decision on the Record

Because the parties have not objected to any of the proposed exhibits, I admit IG Exs. 1-7
and Petitioner’s Exs. A-H into the record. See Order §§ 5, 6, 8.

Both the IG and Petitioner indicated that they did not have any witnesses to offer and that
it was not necessary to hold an in-person hearing. IG Br. at 13; P. Informal Br. at 3.
Therefore, an in-person hearing is unnecessary and I issue this decision on the basis of
the written record.

III. Issue

The sole issue before me is whether Petitioner surrendered his license to practice
medicine while a formal disciplinary proceeding was pending before a state licensing
authority for reasons bearing on his professional competence, professional performance,
or financial integrity. 42 U.S.C. § 1320a-7(b)(4)(B).

IV. Jurisdiction

Ihave jurisdiction to decide this case. 42 C.F.R. §§ 1001.2007(a)(1)-(2), 1005.2(a); see
also 42 U.S.C. § 1320a-7(f)(1).

V. Findings of Fact, Conclusions of Law, and Analysis!

A. There is a basis for Petitioner’s exclusion pursuant to 42 U.S.C. § 1320a-
7(b)(4)(B), and the IG has proven each required element under the statute.

' My findings of fact and conclusions of law are set forth in italics and bold font.
The IG cites 42 U.S.C. § 1320a-7(b)(4) as the basis for Petitioner’s permissive exclusion.
IG Ex. |. The statute provides:

(b) PERMISSIVE EXCLUSION. — The Secretary may
exclude the following individuals and entities from
participation in any Federal health care program

(4) LICENSE REVOCATION OR SUSPENSION. — ANY
INDIVIDUAL OR ENTITY —

(A) whose license to provide health care has been revoked or
suspended by any State licensing authority, or who otherwise
lost such a license or the right to apply for or renew such a
license, for reasons bearing on the individual’s or entity’s
professional competence, professional performance, or
inancial integrity, or

(B) who surrendered such a license while a formal
disciplinary proceeding was pending before such an authority
and the proceeding concerned the individual’s or entity’s
professional competence, professional performance or
inancial integrity.

Thus, the elements that the IG must prove for exclusion pursuant to section 1320a-
7(b)(4)(B) in this case are: (1) Petitioner surrendered his license to provide health care to
a State licensing authority; (2) Petitioner surrendered his license while a formal
disciplinary proceeding was pending before the State licensing authority; and (3) the
pending proceeding involved Petitioner’s professional competence, professional
performance, or financial integrity. For the reasons stated below, I find that the IG has
proven each of these elements.

1. Petitioner surrendered his medical license to a State licensing
authority on September 30, 2013.

In September 2013, Petitioner signed, and the Medical Board approved, a Stipulation and
Final Agency Order whereby Petitioner agreed to permanently relinquish his medical
license in the state of Colorado and not apply for reactivation, reinstatement, or issuance
of a new license to practice medicine in the state of Colorado at any time in the future,
commencing September 30, 2013. IG Ex. 4 at 6-8. The Medical Board is the licensing

authority with jurisdiction over Petitioner in Colorado. Colo. Rev. Stat. §§ 12-36-103,
12-36-104; IG Ex. 4 at 1. Therefore, based on the evidence of record, the first element
under 42 U.S.C. § 1320a-7(b)(4)(B) was proven.

2. Petitioner surrendered his medical license while a formal disciplinary
proceeding was pending before the Colorado Medical Board.

On or about August 7, 2012, the Medical Board filed Case No. 2011-002403-B with the
Office of Administrative Court concerning Petitioner’s improper treatment of Patient A.
See IG Ex. 4 at 1-2. This case was scheduled for a five-day hearing. IG Ex. 4 at 1.
However, Petitioner and the Medical Board executed the Stipulation and Final Agency
Order to settle Case No. 201 1-002403-B, as well as three other cases involving Petitioner
still under Medical Board investigation. IG Ex. 4 at 1-2. In the Stipulation and Final
Agency Order, Petitioner explicitly and knowingly gave up his right to a formal hearing,
and the Stipulation and Final Agency Order provided that it would “have the same force
and effect as an order after a formal hearing.” IG Ex. 4 at 6. Petitioner admits that Case
No. 2011-002403-B was “‘in fact a formal disciplinary proceeding.” P. Br. at 2.

Contradictorily, Petitioner also claims that he closed his practice on September 30, 2013,
for financial reasons and there was no formal disciplinary proceeding pending with the
Medical Board at that time. Petitioner claims this assertion is supported by the
Stipulation and Final Agency Order and email correspondence with the Medical Board.
P. Informal Br. at 2. However, Petitioner did not submit any email correspondence as an
exhibit. Further, the Stipulation and Final Agency Order certainly does not support his
assertion.

The purpose behind 42 U.S.C. § 1320a-7(b)(4)(B) is to “prevent unfit practitioners from
avoiding exclusion through the expedient of surrendering their license before the state
can conclude proceedings against them.” John W. Foderick, M.D., DAB CR43, at 13
(1989), aff’d, DAB No. 1125 (1990). A “formal disciplinary hearing” is “a license
proceeding which places a party’s license in jeopardy and which provides that party with
an opportunity to defend against charges which might result in license suspension or
revocation.” Foderick, DAB CR43, at 6. Further, “[t]he law presumes that an individual
or entity who surrenders a health care license in the face of charges, and in the
circumstance where he has an opportunity to defend himself, is likely to be as
untrustworthy as the individual or entity who loses a license after litigating the issue.”
Foderick, DAB CR43, at 7.

Although a hearing does not have to take place or be scheduled for the license surrender
to have occurred while a formal disciplinary proceeding was pending, Petitioner executed
the Stipulation and Final Agency Order when a lengthy formal hearing was already
scheduled to be held. Consequently, there was a formal disciplinary proceeding pending
against Petitioner within the meaning of 42 U.S.C. § 1320a-7(b)(4)(B), when Petitioner
agreed to relinquish his medical license, and Petitioner only avoided the hearing by
settling the case against him through surrender of his license. See April Ann May, P.A.,
DAB CR1089 (2003). Therefore, based on the evidence of record, the second element
under 42 U.S.C. § 1320a-7(b)(4)(B) was proven.

3. The pending Colorado Medical Board proceeding involved
Petitioner’s professional competence or professional performance.

Petitioner admitted in the Stipulation and Final Agency Order that if the facts alleged
against Petitioner in Medical Board Case No. 2011-002403-B were proven, they would
constitute a prima facie case of unprofessional conduct as defined in the Colorado
Medical Practice Act that would subject him to discipline. IG Ex. 4 at 2,4. Specifically,
the Medical Board found and Petitioner acknowledged that his conduct, if proven, would
have represented unprofessional conduct by: (1) failing to meet generally accepted
standards of medical practice; (2) failing to obtain consultations or referrals when failing
to do so is not consistent with the standard of care for the profession; and (3) falsifying or
repeatedly making incorrect essential entries or repeatedly failing to make essential
entries on patient records. See Colo. Rev. Stat. § 12-36-117(1)(p), (bb)(1), (cc); IG Ex. 4
at 3-4.

According to the Stipulation and Final Agency Order, Medical Board Case No. 2011-
002403-B involved Petitioner’s treatment of Patient A, Petitioner’s treatment of Patient A
allegedly fell below the standard of care and Petitioner’s various failures ultimately
resulted in the amputation of Patient A’s leg due to gangrene. IG Ex. 4 at 2-4. There is
no doubt that the subject of Case No. 201 1-002403-B directly involved Petitioner’s
professional competence and performance. The charges against him included failures to
properly diagnose a muscle infection, to properly document Patient A’s condition, to
leave orders with nursing staff for treatment, to consult with an infectious disease expert
when a rare bacteria was detected in Patient A, and to examine Patient A for many days
following nursing staff requests for Petitioner to do so. IG Ex. 4 at 2-4. Therefore, I find
that the final element under 42 U.S.C. § 1320a-7(b)(4)(B) is satisfied.

Petitioner attempts to collaterally attack the facts and circumstances surrounding the
permanent surrender of his medical license. Petitioner asserts that Patient A sued
Petitioner in civil court and that a jury found in Petitioner’s favor. P. Informal Br. at 4;
P. Ex. C. Petitioner also relies on the opinion of two vascular surgeons, who reviewed
Petitioner’s care of Patient A, and believed that Petitioner’s care met the requisite
standard of care. P. Br. at 5,7. However, Petitioner may not use these proceedings to
collaterally attack the validity of the Medical Board’s action against Petitioner’s medical
license. 42 C.F.R. § 1001.2007(d); see also Travers v. Shalala, 20 F.3d 993, 998 (9th
Cir. 1994); Anderson v. Thompson, 311 F. Supp. 2d at 1128 (D. Kan. 2004).
Petitioner cites to the IG’s nonbinding criteria for implementing permissive exclusions
pursuant to another section of the Act, 42 U.S.C. § 1320a-7(b)(7), and relying on those
criteria, seeks to show his trustworthiness to participate in the federal health care
programs. Even if I were able to review the exercise of the IG’s discretion to impose a
permissive exclusion, which I am not, those criteria are immaterial in this case. Those
criteria are not cognizable mitigating factors in a case under 42 U.S.C. § 1320a-7(b)(4).
Petitioner’s contentions that he never attempted to defraud the federal health care
programs, that he has taken steps to improve the care he provides to patients, and that the
exclusion will deprive him of his livelihood provide no grounds for me to reverse or
reduce the length of his exclusion. See 57 Fed. Reg. 3298, 3316 (Jan. 29, 1992) (“If it is
determined that someone should be excluded from the programs because continued
participation puts the program at risk, the fact that the exclusion may affect his or her
inancial condition is not our concern; our concern is in protecting the programs.”).
Petitioner’s contentions are not relevant here because I cannot review the IG’s decision to
impose a permissive exclusion. See 42 C.F.R. § 1005.4(c)(5). Although I have the
authority to reverse an exclusion, see 42 C.F.R. §§ 1001.3005(a)(3), 1005.20(b), I can
only do so if the IG has failed to prove that there is a basis for the exclusion. See

42 CFR. § 1001.2007(a), 1005.15(b)(2); Keith Michael Everman, D.C., DAB No. 1880
(2003).

B. The length of Petitioner’s exclusion is reasonable as a matter of law.

I conclude that the period of exclusion, which is until the Medical Board reinstates
Petitioner’s medical license, is required by 42 U.S.C. § 1320a-7(c)(3)(E). I cannot waive
the requirement that Petitioner regain his Colorado license in order for the exclusion to
end. See 42 C.F.R. § 1005.4(c)(1).

Pursuant to 42 U.S.C. § 1320a-7(c)(3)(E), the period of exclusion “shall not be less than
the period during which the individual’s or entity’s license to provide health care is
revoked, suspended, or surrendered .. . .” Petitioner has not presented any evidence to
support that he has been reinstated as a physician in Colorado. Therefore, I conclude that
the period of exclusion is mandated by law under 42 U.S.C. § 1320a-7(c)(3)(E), based on
the facts in the record.
VI. Conclusion

For the foregoing reasons, I affirm the IG’s determination to exclude Petitioner from
participating in Medicare, Medicaid, and all federal health care programs pursuant to
42 USC. § 1320a-7(b)(4).

/s/
Scott Anderson
Administrative Law Judge