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7-0900-19965-2 |
STATE OF
OFFICE OF
ADMINISTRATIVE HEARINGS
FOR THE COMMISSIONER OF HEALTH
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In the Matter of Survey Exit
Date: April 18, 2008 |
RECOMMENDED DECISION |
The above matter was the subject of an Independent Informal Dispute Resolution
(IIDR) conference conducted by Administrative Law Judge Richard C. Luis on November
24, 2008. The conference was held at the
Office of Administrative Hearings in
Marci Martinson, R.N., IIDR Coordinator,
Licensing and Certification Program, appeared on behalf of the Department of
Health’s Division of Compliance Monitoring. Mary Cahill, Planner Principal with the Division
of Compliance Monitoring, also participated in the conference.
Susan Schaffer, Attorney at Law, appeared on
behalf of Oak Terrace Health
Care Center of Gaylord (Oak Terrace or Facility). The
following persons made comments on behalf of the Facility: Roxanne Gosson,
Facility Administrator and Holly Kranz, R.N., Director of Nursing for the
Facility.
FINDINGS OF FACT
1.
On
April 18, 2008, the Department of Health’s Office of Health Facility Complaints
(OHFC) conducted a standard survey at Oak Terrace Health Care Center, a nursing
home located in
2.
Oak
Terrace disputes certain findings and determinations about two residents (Resident
#2 and Resident #8) in the three level G deficiencies made by OHFC in its SOD. In response to the issuance of the SOD, Oak
Terrace filed a Request for Independent Informal Dispute Resolution.
Resident #2
3.
Resident #2 was admitted to Oak Terrace on
November 28, 2007, after a fall resulted in a fracture. Resident #2 was diagnosed with osteoarthrosis,
malaise and fatigue, anemia, polymyalgia rheumatica. depression and severe
aortic stenosis. From December 1, 2007, Resident #2 has had a history
of black bloody stools. At that time,
Resident #2 was observed to have bruising over much of her body. The test of her blood coagulants (International
Normalized Ratio or INR) was measured at that time at 1.08. That INR score would fall within the expected
results for anticoagulant effect.[2]
4.
On
January 22, 2008, more bruising was observed on Resident #2. No specific sources of these injuries were
identified. Similar bruising was noted
on January 28, 2008. The physician noted
the bruising and indicated that Resident #2’s condition should be followed up
on in one month.[3]
5.
On
January 30, 2008, Resident #2 was complaining of headache and exhibited blood
pressure of 82/53. The physician was
notified at that time, but Resident #2’s condition stabilized. Resident #2 often exhibited low blood
pressure, attributed to her condition of aortic stenosis.[4]
6.
On
February 14, 2008, Resident #2’s hemoglobin was measured at 10.3., She was hospitalization at Abbot Northwestern
at this time due to influenza. [5]
7.
On March 10, 2008, Resident #2 visited a clinic
to address frequent incontinence and loose stools. As part of that review, Resident #2’s
physician prescribed the anticoagulant medication, Coumadin. On March 13, 2008, Resident #2 started on
Coumadin at the dosage of 5 mg daily for 2 days and then 2.5 mg daily after the
5 mg dosage was complete. This regimen
continued until March 31, 2008. The
existing anticoagulant medication Resident #2 had been taking was discontinued
when she began the Coumadin regimen.[6]
8.
As part of the Coumadin regimen, the Facility
staff was directed by the physician to check Resident #2’s Prothrombin Time (protime
or PT) and INR levels in about four days to ensure that therapeutic levels of
anticoagulant were reached. On March 17,
2008, Resident #2’s INR was 1.9. The
physician ordered a recheck in three weeks.
On March 21, 2008, Resident #2 was seen again by the physician, who
ordered the Coumadin continued at the current dose. Regarding the problems Resident #2 had been
having with stools, the physician diagnosed possible colostrum difficile or
aggravation of diverticulitis. Bloody
stool is a symptom of diverticulitis that staff were directed to watch for by
the physician.[7]
9.
On March 22, 2008, Resident #2 did not report
any pain or discomfort. She went out
with relatives the next day and reported no problems. Resident #2’s blood pressure was checked upon
her return to the facility and it was 87/56, which was low, but within Resident
#2’s normal range. Staff continued to
monitor for the problems previously identified.[8]
10.
On March 25, 2008, Resident #2 did have bloody
mucus on her bed pad. Another stool
sample was sent to the lab for analysis.
Resident #2’s stool was dark but not bloody. No
complaints of pain or discomfort were made by Resident #2 at that time.[9]
11.
On March 26, 2008, Resident #2’s condition was
observed to be normal, with no fever and no diarrhea. The C.
Difficile test results were returned as positive, meaning that Resident #2
did have signs of a possible infection of the colon caused by bacteria that can
follow the use of antibiotics. Such an
infection can cause a form of colitis.
Resident #2’s physician prescribed Flagyl in response to the C. Difficile test results.[10]
12.
On March
27, 2008, Resident #2 was started on Flagyl, administered three times per day
with the medication to run for two weeks.
No complaints of pain or discomfort were made by Resident #2 at that
time. No unusual discharges or other
problems were observed.[11]
13.
On March
28, 2008, Resident #2 was observed at 7:00 a.m. with blood in her mouth. Upon examination by an L.P.N. from the
Facility’s nursing staff, the blood in Resident #2’s mouth was determined to
coming from a sore. On her leg near the
ankle, she had a skin tear leaking blood with a 7 cm bruise surrounding the
tear (suggesting the she had bumped her ankle to cause the injury). The L.P.N. dressed and bandaged the injury. Resident #2 could not recall how she suffered
that injury. When family members visited
that morning they were informed of the situation. The Facility staff offered to have Resident
#2 seen by a physician at that time. The
family members (including one who is an R.N. who worked for the Facility) indicated
that faxing the information to the physician was sufficient. There were no indications that Resident #2 was
in any distress on the morning of March 28, 2008. Resident #2’s physician was notified of these
conditions by fax at 11:30 a.m. Facility
staff instituted salt water rinses to address the observed sore in Resident
#2’s mouth.[12]
14.
On March
29, 2008, Resident #2 had the ankle wound dressing replaced. Staff noted there was drainage on the
dressing from a skin tear. The drainage
had dried on the dressing and the dressing needed to be soaked to remove it
from Resident #2’s ankle. The nursing
staff observed Resident #2’s mouth to follow up on the observation from the
prior day. No bleeding from her mouth
was noted. Salt water rinses were
continued to address the observed sore. [13]
15.
On
March 30, 2008, Resident #2’s culture results were returned that ruled out parasites,
salmonella, or shigellosis. Those
results were faxed to Resident #2’s physician.
No other problems were observed regarding Resident #2’s condition. [14]
16.
On March
31, 2008, nursing staff noted that Resident #2 had two black and bloody stools
with blood in toilet. At 9:50 a.m., the
on-call physician was notified. The
on-call physician reviewed Resident #2’s condition. Based on that review, the physician ordered
Coumadin and aspirin stopped and that Resident #2 have a blood count taken. The physician also ordered that a Protime/INR
test be performed the next morning. The
physician instructed that she should be called back if further bloody stool was
observed. The physician indicated that
Resident #2’s regular physician should be updated with the results the next
day. A family member was also contacted
about Resident #2’s condition. [15]
17.
In the morning on March 31, 2008, Resident #2’s
vital signs were blood pressure 77/47 and pulse 63. Resident #2 was alert and oriented with no
dizziness, headaches, or pain. A nursing
note entry was made at 2 p.m. when the nursing staff checked Resident #2’s
mouth and found no bleeding. The note
also indicated that Resident #2 “had 1 black/bloody stool shortly after talking
with ... (on call physician).“ Resident
#2’s blood pressure was 93/55 and nursing staff noted that they should continue
to monitor Resident #2 for further loose or black stools and update the on-call
physician if it continues. At 3:15 p.m.
the nursing note indicated that Resident #2 had a large formed bloody-looking stool. The on-call physician was called and that
physician called back at about 4:00 p.m. to have Resident #2 transferred to
hospital. Oak Terrace staff called 911
for transport. [16]
18.
Resident #2 was transported to the hospital by
ambulance where she was admitted. The
emergency room physician noted Flagyl had been started. Resident #2 was diagnosed with clostridium difficile
infection, urosepsis and a gastrointestinal bleed. Blood testing done at the hospital indicated
that the Resident #2’s INR level was 17 and hemoglobin was 10. Resident #2 exhibited normal blood pressure
at the hospital and she had no complaints of pain or discomfort.[17]
Resident #8
19.
Resident #8 was admitted to Oak Terrace on May
25, 2006. His diagnoses included
depression, hypertension, history of cerebral vascular accident, atrial
fibrillation, congestive heart failure, and gastrostomy. Resident #8 was placed
on Coumadin on February 6, 2008, at a dosage of 5 mgs daily. This dosage was increased on February 20, 2008
to 6 mg. Resident #8 was on Dilantin,
300 mg. The Dilantin (Phenytoin) was
administered at 8 AM daily from the time of his admission. In addition, he
received Paxil, an antidepressant, 20 mg per day. [18]
20.
The Facility nursing notes for Resident #8
reflect the following chronology of events in his care:
|
Date |
Lab &
Follow-up |
|
1/18/08 |
INR 1.3 PROTIME 12.9 |
|
1/24/08 |
INR 1.6 PROTIME 15.3 |
|
2/6/08 |
INR 1.4 PROTIME 13.3 |
|
2/13/08 |
INR 1.8 PROTIME 16.9 |
|
2/20/08 |
INR 1.7 PROTIME 15.9 |
|
2/27/08 |
INR 2.3 PROTIME 21.2 |
|
3/13/08 |
INR 3.8 PROTIME 34.3 Oak Terrace Nurse faxed lab and med sheets to New Ulm Medical Center Clinic (4 pages, including med sheets) Physician order for Coumadin 5 mg. on M & F, 6 mg all other days. Re[check] 4/3. Physician also wrote to “fax med sheets on date of draw.” |
|
4/3/08 |
INR 7.0 PROTIME 60.7 1:15 PT results faxed to Dr. Seivert. 2:50 Left with wife Marilyn, for getting eye glasses fixed. 4:00 Call placed to Coumadin clinic to inquire about INR fax — left message. 8:00 [NO] return call from coumadin clinic, [no] fax return. Coumadin held due to critical high PT/INR. 10:00 Fax sent to coumadin clinic with PT/INR results & medication sheets. |
|
4/4/08 |
10 AM — Fax returned from the coumadin clinic. See new orders to hold coumadin & redraw PT/INR on Monday, 4/7/08, call placed to SMC-Gaylord — lab appt scheduled for 4/7/08 at 8:45 AM. |
|
4/7/08 |
INR 1.3 PROTIME 12.4. [19] |
21.
The Coumadin clinic is operated as an adjunct to
New Ulm hospital. The Coumadin clinic is
not open in the evening or overnight. [20]
22.
The increased PT/INR levels that Resident #8
experienced on April 3, 2008 did not result in any adverse health impact to
him. No medical intervention was
required and Resident #8 did not exhibit any symptom or condition that would
suggest a need for medical intervention.[21]
Resident #8’s condition was deemed sufficiently stable by the
responsible medical authority that Resident #8 was not directed to be retested
for PT/INR levels until the third day after the report of the increased level.
23.
Upon being notified of the results of the
Resident #8’s situation, the Facility’s Director of Nursing prepared an update
of the Facility’s policy that would expressly address Coumadin issues.[22]
24.
The
Facility’s Consulting Pharmacist assessed the potential impact of Resident #8’s
medications and concluded that “the combination of these medications had been
occurring for a number of months and thus any enzymatic activity of the
cytochrome P-450 system would no longer be relevant.”[23] The Facility’s pharmacist concluded, based on
a review of the relevant professional literature, that there was no drug
interaction between Resident #8’s medications that would cause the change to
Resident #8’s INR score.[24]
25.
The system in place for notifying the
responsible prescribing authority of changes in patient condition was deficient
in that there was no mechanism to promptly address the known unavailablity of
staff at the Coumadin clinic. This
deficiency was part of a pattern, but did not result in actual harm. The deficiency had the potential for more
than minimal harm. The proper scope and
severity level for the deficiency is level E.[25]
Survey
26.
The OHFC
conducted a standard survey of the Facility that concluded on April 18,
2007. The survey team reviewed residents’
medical records, conducted interviews, and examined Facility documentation
relating to a number of residents, including Resident #2 and Resident #8.[26] The interviews did not discuss Resident #2.[27]
27.
Survey
team members informed Facility staff that seven deficiencies were identified
for which F-tags would be issued. These
F-tags were assigned severity levels of B (two tags), D (three tags), and E
(two tags). Members of the survey team
were complimentary regarding the care that was provided in the Facility.[28]
28.
At the
conclusion of the visit, OHFC staff conducted an exit interview where seven
deficiencies were identified, each listed as an F-tag. The deficiencies ranged from severity levels
B to E.[29] The F-157 tag, regarding physician
notification, was identified as severity level E.
29.
In the
week following the survey, several telephone conversations took place between
staff at OHFC and Oak Terrace. Oak
Terrace was informed that another deficiency was being added at severity level
G and two of the earlier deficiencies were being increased to severity level G.[30]
30.
On May
2, 2008, OHFC issued its SOD identifying eight deficiencies, three of them at
severity level G. One G level tag (F
309) had not been discussed at the exit conference.[31]
31.
Some of
the appealed tags were supported by deficiencies found regarding residents
where the findings were not appealed. In
those instances, the scope and severity level of the overall tag cannot be changed. The appropriate action in those instances is
to modify the findings with regard to those tags.
Based upon the exhibits
submitted and the arguments made and for the reasons set out in the Memorandum
that follows, the Administrative Law Judge makes the following:
RECOMMENDED
DECISION
The citation with
regard to Tag F 157 is supported by the facts as to Resident #8, but the scope
and severity level is properly assigned to level E. The citation with regard to Tag F 157 is not
supported by the facts as to Resident #2 and findings in that regard should be
deleted. The citation regarding Tag F
309 is not supported by the facts and should be deleted. The portion of the citations with regard to
Residents #2 and #8 in Tag F 329 are not supported by the facts and the
findings should be deleted with regard to those two residents.
Dated: December 10, 2008.
|
/s/ Richard C. Luis |
|
RICHARD C. LUIS |
|
Administrative Law Judge |
Reported: Digitally recorded
(no transcript prepared).
In
accordance with Minn. Stat. § 144A.10, subd. 16(d)(6), this recommended
decision is not binding on the Commissioner of Health. As set forth in Department of Health
Information Bulletin 04-07, the Commissioner must mail a final decision to the
Facility indicating whether or not the Commissioner accepts or rejects the
recommended decision of the Administrative Law Judge within 10 calendar days of
receipt of this recommended decision.
MEMORANDUM
Scope of Review in IIDR
Proceedings
OHFC maintains that the Facility cannot
challenge the scope and severity level of the deficiencies found in the survey,
unless a monetary penalty is affected by the appeal. The Facility points out that the state law
governing the IIDR process explicitly allows challenges to scope and severity.
The Minnesota Department of Health described
the ALJ findings in the IIDR process in an informational bulletin as follows:
The findings shall be one or more of the following:
Supported in full. The citation is supported in full, with no deletion of findings and no change in the scope or severity assigned to the deficiency citation.
Supported by substance. The citation is supported, but one or more findings are deleted without any change in the scope or severity assigned to the deficiency.
Deficient practice cited under wrong requirement of participation. The citation is amended by moving it to the correct requirement of participation.
Scope not supported. The citation is amended through a change in the scope assigned to the citation.
Severity not supported. The citation is amended through a change in the severity assigned to the citation.
Not deficient practice. The citation is deleted because the findings did support the citation or the negative resident outcome was unavoidable.
The findings of the ALJ are not binding on the commissioner.[32]
According to the Department description of this process, both the scope and severity of deficiencies are at issue in these proceedings. The ALJ findings must reflect the record as to whether the deficiency is supported, and if so, what is the appropriate scope and severity rating. This description is nearly identical to the provisions of Minn. Stat. § 144A.10 subd. 16(d). OHFC has not cited any authority that overrides the requirements of State law in the IIDR process.
The OHFC position appears to be based on 42 CFR § 498.3, which describes issues appealable before an ALJ as:
(14) The level of noncompliance found by CMS in a SNF or NF but only if a successful challenge on this issue would affect—
(i) The range of civil money penalty amounts that CMS could collect (The scope of review during a hearing on imposition of a civil money penalty is set forth in §488.438(e) of this chapter); or
(ii) A finding of substandard quality of care that results in the loss of approval for a SNF or NF of its nurse aide training program.[33]
This provision applies to appeals where CMS (or where authorized, the State agency) has issued a determination resulting in a civil money penalty (CMP) or determination of ineligiblity for continuation as an authorized care provider. No such determination is made at this stage in the IIDR process. The formal appeal process is set out in Section 7303 of the SOM. Limitations to the formal appeal process were described in a recent administrative appeal which stated:
A long-term
care facility against which CMS has
determined to impose a CMP is entitled to a hearing before an ALJ. Act, section 1128A(c)(2); 42 C.F.R. §§
488.408(g);498.3(b)(13). A hearing
before an ALJ is a de novo proceeding. Anesthesiologists
Affiliated, et al., DAB CR65 (1990), aff’d, Anesthesiologists Affiliated, et
al. v. Sullivan, 941 F.2d 678 (8th Cir. 1991). The
facility has a right to appeal a “certification of noncompliance leading to an
enforcement remedy.” 42 C.F.R. §
488.408(g)(1); see also 42 C.F.R. § 488.330(e). However, the
choice of remedies by CMS or the factors CMS considered in choosing remedies
are not reviewed. 42 C.F.R. §
488.408(g)(2). A facility may only
challenge the scope and severity level of noncompliance found by CMS if a
successful challenge would affect the CMP amount that could be collected by CMS
or impact upon the facility’s NATCEP [Nurse Aide Training and Competency
Evaluation Program]. 42 C.F.R. §§
498.3(b)(14) and (d)(10)(i). CMS’s
determination as to the level of noncompliance “must be upheld unless it is
clearly erroneous.” 42 C.F.R. §
498.60(c)(2). This includes CMS’s
finding of IJ [immediate jeopardy].
The limitations on appeals of CMS decisions
are reasonable, especially since facilities are able to dispute scope and
severity assessments through the IIDR process.
Imposing such a limitation at this stage of the proceedings is contrary
to State law and would undermine the existing CMS appeal structure.
Matters Disputed
There is no dispute that the exit conference
is not final until after the final written report is issued. The Facility disputes the findings arrived at
through the survey and the three G-level tags issued based on those findings
with regard to Residents #2 and #8.
Tag F 157
Tag F 157 is based upon an alleged violation
of 42 C.F.R. § 483.10(b)(1). That
provision requires that:
A facility must Immediately inform the
resident; consult with the residents physician; and if known, notify the
residents legal representative or an interested family member when there is an accident
involving the resident which results in injury and has the potential for
requiring physician intervention; 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); a need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse consequences, or to
commence a new form of treatment); or a decision to transfer or discharge the
resident from the facility as specified in §483.12(a).[35]
OHFC did not dispute the Facility’s
recounting of the care provided to Resident #2.
The OHFC position on Resident #2 was that the concurrent administration
of Coumadin and Flagyl, together with the bleeding experienced from her ankle
injury created a situation where the Facility “should have made sure that the
physician was informed.”[36] This position is based on the perception that
Resident #2 was at some sort of risk due to her anticoagulant medications. This position would have some merit if
Resident #2 was showing signs of bleeding without an external cause. All of the bleeding exhibited by Resident #2
was attributable to either a sore (mouth) or an accidental injury (ankle). In both instances, there was an external
cause and the actions taken to address the bleeding, salt rinses (mouth) and
bandaging (ankle) were effective.
OHFC asserts that the Facility had an obligation
to ensure that a physician was contacted and and the Facility could not involve
Resident #2’s family in the decision-making process. The situation presented to the Facility and
Resident #2’s family was not of a nature to require physician intervention. The Facility had provided the care needed to
address Resident #2’s explained bleeding.
The level of care required did not rise to the level that would cause a
reasonable person to think that anything more than informing Resident #2’s
physician of changes was needed. The
absence of any situation needing a response by a physician made faxing the
information reasonable.
For Resident #2, the Facility notified the
resident, resident’s physican, and resident’s family on the morning that the
injury was first observed. The injury
did not require physician intervention.
Because Resident #2 was taking anticoagulant medications, there was a
potential for physician intervention.
Faxing the physician with Resident #2’s updated conditon was sufficient
notfiication under the CF.R. requirement.
OHFC maintains that there was some further
obligation to follow-up with the physician.
There were no symptoms arising from either the mouth sore or the ankle
injury that in any way triggered a clinical concern as to Resident #2’s
anticoagulant medications. The symptom
(bloody stool) which triggered the further contact with Resident #2’s
physician, first occurred two days later.
The Facility responded appropriately at that time. There was no actual harm arising out of the
Facility’s action in notifying Resident #2’s physician. There is no factual basis for finding a
deficiency for that resident under F 157.
For Resident #8, the Facility recognized
that the measured PT/INR was higher than appropriate. The Facility made multiple effforts to notify
either the Coumadin clinic or Resident #8’s physician. When those efforts failed to get a response,
the Facility nursing staff acted to protect Resident #8’s health by withholding
the prescribed Coumadin.
The efforts to contact the responsible
precribing authority were consistent with the Facility’s existing protocol, but
that protocol did not take into account the limitations of resources in the
area. The Facility was aware of the limited
resources in the area and of the need for better communication. This constitutes a deficiency that falls
under the scope of a pattern (since any resident using the Coumadin clinic
would be affected). The deficiency did
not rise to the level of actual harm, since variations in PT/INR test results
of the sort shown by Resident #8 are not intrisically harmful (or even unusual)
and the Facility acted promptly to address the elevated PT/INR results. The severity level meets the potential for
more than minimal harm. Level E is the
appropriate scope and severity standard for this deficiency.
Tag F 309
Tag F 309 is based upon an alleged violation
of 42 C.F.R. § 483.25. That provision
requires that:
Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.[37]
OHFC maintains that the Facility was deficient in this standard due to a failure to monitor Residents #2 and #8 with respect to their anticoagulant medications. Specifically regarding Resident #2, OHFC maintains that her plan of treatment needed to be adjusted to reflect the addition of Flagyl to her medication regimen. The objection was focused on the Facility’s use of a fax for notification on March 28, 2008.
OHFC cited the risks of Coumandin, particularly the warning for “unusual bruising (bruises that develop without known cause or grow in size)” as evidence that actual harm was occuring to Resident.[38] The Facility responded that the presence of a skin tear in the middle of the bruising on Resident #2’s ankle renders this bruising different from the cited concern. The presence of the skin tear indicated that the bruising occurred though some form of external cause, not arising from a dangerous drug interaction. The effectiveness of the treatment provided to both the sites of observed bleeding (mouth and ankle) is further evidence that there was no failure to meet the cited standard. There is no factual basis for finding a deficiency for Resident #2 under F 309.
Regarding Resident #8, the only monitoring that was required was the PT/INR test given on April 3, 2008. The results of that testing was faxed, by the physician’s instruction, to the Coumadin clinic. There was no further monitoring called for, since the next day the Coumadin clinic directed that a retest be performed on April 7, 2008. The Facility fully met its obligation to monitor the medication being given to Resident #8. There is no factual basis for finding a deficiency for Resident #8 under F 309.
Tag F 329
Tag F 329 is based upon an alleged violation
of 42 C.F.R. § 483.25 (l). That provision requires that:
Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used in excessive dose (including duplicate therapy); or for excessive duration; or without adequate monitoring; or without adequate indications for its use; or in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or any combinations of the reasons above.
Based on a comprehensive assessment of a resident, the facility must ensure that residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.
OHFC cited numerous portions of the State Operations Manual in support of the contention that Oak Terrace was deficient in the standards for administration of unnecesary drugs. These standards all reflect the Facilty’s obligation to monitor residents receiving medications for drug interaction or negative effects arising from the medication.[39]
OHFC maintains that the Facility was deficient regarding this standard with respect to Resident #2 because she “was hospitalized on 3/31/08 wIth a level of Protime of 169 and INR of 17 and experienced harm because of inadequate monitoring of another drug added to the drug regime on 3/25/08 identified to increase the toxic effects of Coumadin.”[40] OHFC made a factual error in the date the second medication was started (March 27, 2008).
Oak Terrace noted that pharmaceutical reference works indicate the need for increased monitoring of anticoagulant effects when Coumadin and Flagyl are used together. There is no accepted monitoring regimen for anticoagulants due to the variety of factors involved. The timing of such laboratory testing is a matter of clinical opinion between practitioners and differs for different patients. [41]
There were no signs of drug interaction from which to conclude that any further physician intervention was needed to care for Resident #2 from March 27, 2008, until March 31, 2008. As discussed above, Resident #2’s mouth and ankle bleeding were observed to have external causes and they responded to the care given. On March 31, 2008, Facility staff recognized the symptoms of a potential drug interaction (bloody stools) and took prompt and effective measures to notify Resident #2’s physican and transport Resident #2 to a hospital for closer observation. There is no factual basis for concluding that the Facility’s care of Resident #2 was deficient. Tag F 329 regarding Resident #2 is not supported.
OHFC maintains that the Facility was deficient regarding this standard with respect to Resident #8 because of his “cntlcally high blood test results and the facility failed [to] notify the physician in a timely manner nor provided evidence of a medication regime review to identify the potential for increased bleeding time because of concomitant use of several medications Resident #8 had been getting in combination with the Coumadln, known to have the potential to increase the clotting time of Coumadin resulting in harm.”[42]
The Facility has demonstrated that it conducted the testing according to the prescribed schedule. The Facility acted promptly when an elevated PT/INR result was returned. The Facility retested according to the direction provided by the responsible prescribing authority. The Facility has shown that there is no factual support for a claim of drug interaction regarding Resident #8. There is no factual basis for the claimed deficiency arising from either a drug interaction or excessive dosage of Coumadin.
Conclusion
Based upon the record as a whole, the Administrative Law Judge concludes the OHFC has demonstrated that only one cited deficiency is supported by the facts. That citation was supported by the facts at a scope and severity level of E. Accordingly, it is recommended that Tag F 157 be AFFIRMED with a modication of the scope and severity level to E regarding Resident #8. It is appropriate to adjust the remaining findings and tags as indicated above.
R.C.L.
[1] MDH Ex. G.
[2] Testimony of Kranz. As a general matter, the parties did not dispute the factual basis of the care provided. The testimony recited information that is drawn directly from the nursing notes and interpreted to make abbreviations and terms of art more readily understandable.
[3] Testimony of Kranz.
[4] Testimony of Kranz.
[5] Testimony of Kranz.
[6] Testimony of Kranz.
[7] Testimony of Kranz.
[8] Testimony of Kranz.
[9] Testimony of Kranz.
[10] Testimony of Kranz.
[11] Testimony of Kranz.
[12] Testimony of Kranz.
[13] Testimony of Kranz.
[14] Testimony of Kranz.
[15] Testimony of Kranz.
[16] Testimony of Kranz.
[17] Testimony of Kranz.
[18] Testimony of Kranz.
[19] Facility Ex. R8-F through P.
[20] Testimony of Kranz.
[21] Testimony of Kranz.
[22] Testimony of Kranz.
[23] Facility Ex. R8-B.
[24]
[25] SOM, Section 7400E1 (http://www.cms.hhs.gov/manuals/downloads/som107c07.pdf).
[26] Testimony of Gossen.
[27] Testimony of Kranz.
[28] Testimony of Gossen.
[29] Testimony of Gosson.
[30] Testimony of Gosson.
[31] Testimony of Gosson.
[32] Information Bulletin 04-07 NH-98 (May, 2004) (http://www.health.state.mn.us/divs/fpc/profinfo/ib04_7.html).
[33] 42 CFR § 498.39(b)(14).
[34] In the Case of Green County Care Center v.Centers for Medicare & Medicaid Services, Department of Health and Human Services Docket No. C-08-67, DAB Decision No. CR1716, at 3-4 (December 19, 2007) (http://www.hhs.gov/dab/decisions/CR1716.pdf) (emphasis added).
[35] 42 C.F.R. § 483.10(b)(1).
[36] Testimony of Martinson.
[37] 42 C.F.R. § 483.25.
[38] MDH Ex. K-1.
[39] MDH Ex. F.
[40] MDH Ex. G-22.
[41] Testimony of Kranz.
[42] MDH Ex. G-25.