Submitted: October 19, 2017
Upon
Appeal from the Delaware Board of Nursing
Daniel
A. Griffith, Esquire, Attorney for Appellant.
Carla
A.K. Jarosz, Esquire, Deputy Attorney General Attorney for
Appellee.
OPINION AND ORDER
Ferris
W. Wharton, Judge.
I.
INTRODUCTION
Christine
Francis and Angela DeBenedictis ("Appellants" or
"nurses") filed their Notice of Appeal on October
21, 2016, requesting judicial review of the October 7, 2016
order by the Delaware Board of Nursing ("Board").
Ms. Francis and Ms. DeBenedictis contend that the Board's
disciplinary Order was in error.
In
considering this appeal, the Court must determine whether the
Board's decision to discipline Ms. Francis and Ms.
DeBenedictis is supported by substantial evidence and free of
legal error. Upon consideration of the pleadings before the
Court and the record below, the Court finds that there is
insubstantial evidence to support the Board's ruling, and
therefore, the Board erred in reaching its decision.
Accordingly, the Board's decision is
REVERSED.
II.
FACTUAL AND PROCEDURAL CONTEXT
Ms.
Francis and Ms. Debenedictis are Registered Nurse licensees
of the Delaware Board of Nursing (the
"Board").[1] On March 17, 2015 Ms. Francis and Ms.
Debenedictis returned Sovaldi pills to a pill container to be
administered after they had been spilled and discarded into a
sharps container.[2] Because they returned the discarded pills,
a Hearing Officer found Ms. Francis and Ms. Debenedictis in
violation of various Delaware Board of Nursing Board
Regulations ("the Board
Regulations").[3] Ms. Francis and Ms. DeBenedictis filed
combined written exceptions to the Hearing Officer's
Recommendation, but the Board affirmed the Recommendation in
full.[4] Ms. Francis and Ms. DeBenedictis now
appeal that finding.
The
State of Delaware has a constitutional obligation to provide
adequate healthcare for its inmate population.[5] The State may
discharge this obligation either by employing its own medical
providers at the correctional facilities or by contracting
with private companies whose employees work at the
correctional facilities. In March 2015, the Department of
Corrections ("DOC") had a contract with Connections
Community Support Programs, Inc. ("Connections")
for the provision of general, non-specialized treatment of
DOC patients.[6] DOC also had a separate contract with
CorrectRX Pharmacy Services, Inc. ("CorrectRX") to
run the pharmaceutical services at the Delaware correctional
facilities.[7]
Dr.
Jamie McGee was the clinical pharmacist assigned by CorrectRX
to work on-site at the James T. Vaughn Correctional Center
("JTVCC").[8] Dr. McGee's direct supervisor at
CorrectRX was Dr. Valerie Barnes.[9] Connections employed the
other pertinent actors: administering nurses Megan Bowerson
and Roxanna Gonzalez; Nursing Supervisor and Health Services
Administrator at JTVCC Christine Francis; Director of Nursing
Angela DeBenedictis; and statewide medical director for
Connections Dr. Laurie Ann Spraga.[10]
Patient
DL is an inmate at JTVCC.[11] He has Hepacitis C and is
prescribed Sovaldi as treatment.[12] Each Sovaldi tablet costs
approximately $1, 000.00 and a full bottle contains 28
tabs.[13] Due to its high costs, Connections
strictly monitored the drug by counting it at every shift
change and maintaining a log of its usage.[14]
On
March 17, 2015 Nurse Gonzalez completed her shift at JTVCC
and was to be replaced by Nurse Bowerson. As required, the
nurses counted the Sovaldi tablets and, in the course
thereof, Nurse Bowerson spilled twelve tablets onto the
floor.[15] Ms. Bowerson "wasted" the
pills into the "sharps" container-a box intended
for "biohazard" materials-and noted on a Controlled
Substance Usage Log that the pills had been
discarded.[16] Because this caused the pill count to be
12 fewer than previous and the prescribed course of treatment
required the patient to ingest the 12 pills over 12 days, the
pills needed to be replaced quickly.
Nurse
Bowerson contacted the on-site CorrectRX Pharmacist, Dr.
McGee, to request a refill of the Sovaldi
pills.[17] Dr. McGee, in turn, contacted her boss,
Dr. Barnes, who contacted Dr. Spraga.[18] Dr. Barnes
informed Dr. Spraga that 12 Sovaldi pills had been wasted and
"asked Dr. Spraga to arrange for the retrieval of the
pills."[19] Dr. Spraga then contacted Ms. Francis
and told her to retrieve the Sovaldi pills from the sharps
container.[20] Upon Dr. Spraga's directive, Ms.
Francis and Ms. DeBenedictis proceeded to the pharmacy,
located the sharps container, turned it over, and shook it
until the 12 pills finally fell out.[21] Included in the waste
that fell from the container were retractable insulin
syringes, retractable lancets, and diabetic test
strips.[22] There was additional material in the
sharps container, but no one knows what exactly it
was.[23]
The
retrieved Sovaldi pills were taken to Nurse Francis'
office and inspected by Nurses Francis and
DeBenedictis.[24] Dr. McGee, upon the request from Dr.
Barnes, came to Nurse Francis' office to inspect the
Sovaldi pills herself.[25] Dr. McGee has previously conducted
inspections of pills approximately 20-25 times in the past to
determine if they had been tampered with, altered, split or
had previously been "cheeked" in a human
mouth.[26]
Knowing
that the pills had been wasted, Dr. McGee performed a visual
inspection and determined that the tablets did not show any
"visible signs of contamination in the form of blood,
dirt, water, or other damage."[27] Furthermore, the pills
looked new, "as if they had just come out of the
bottle."[28] Dr. McGee and Dr. Barnes then decided
that the pills would be returned to the bottle for
administration.[29] Dr. Spraga acquiesced to the two
pharmacists decision as they were the "subject matter
experts."[30]
Dr.
McGee and Ms. Francis-with full knowledge of the pills
adventure- personally returned the tablets to their original
bottle and updated inmate DL's Sovaldi usage
log.[31] Inmate DL ultimately ingested the
"wasted" Sovaldi pills and was told of the incident
several days afterward.[32] He has suffered no ill effects.
On
March, 26, 2015 Nurse Bowerson lodged a complaint with the
Department of State's Division of Professional Regulation
("DPR") against nurses Francis and DeBenedictis.
The State filed claims against the pharmacists, Dr. Spraga,
and nurses Francis and DeBenedictis. Dr. McGee and Dr. Barnes
had given statements during the investigation denying any
involvement in the decision to return the pills to the
bottle, and consequently the State discontinued the pursuit
of claims against them. The State only proceeded against Dr.
Spraga, Ms. Francis, and Ms. DeBenedictis.
Proceedings
Before the Hearing Officer
On June
15 and 16, 2016 a Hearing Officer conducted a hearing on the
State's Complaint.[33] The claims against Dr. Spraga, Ms.
Francis, and Ms. DeBenedictis were consolidated for purposes
of the hearing. The State proceeded on the theory, consistent
with the prehearing interviews conducted by the DPR
investigators, that the pharmacists were unaware the pills
had been wasted in a sharps container, that Dr. Spraga
unilaterally decided to return the pills, and that the nurses
acted unethically by retrieving the wasted pills and
returning them to the container for administration.
In
addition to their own testimony, Ms. Francis and Ms.
DeBenedictis offered the testimony of two expert witnesses:
Kathryn Wild and Dr. Paul Axelson. In particular, Ms. Wild is
an expert in nursing practice and correctional
healthcare.[34]Dr. Axelson is an expert in the fields of
internal medicine, infectious disease, and
pharmacology.[35] Dr. Axelson testified that in his
opinion, administration of the wasted Sovaldi pills to the
patient was acceptable despite the pills
"adventure" in the sharps container.[36] Both experts
testified that the harm to the patient was nil or
incalculably small and they personally would have ingested
the wasted tablets.[37]
During
the Hearing Officer's findings of fact, the most
contested issues were (1) the knowledge of the pharmacists
and (2) their role in decision-making; whether the
pharmacists were aware of the pills "adventure"
prior to deciding to return the pills or whether the
pharmacists were complicit in the decision to reuse the
pills. The Hearing Examiner found as a fact that both
pharmacists, Dr. McGee and Dr. Barnes, were aware that the
pills had been removed from the sharps container and decided
to return the pills.[38] Furthermore, the Hearing Examiner found
that Ms. Francis and Ms. DeBenedictis trusted Dr. McGee's
judgment and followed that decision because it was a
directive.[39]
The
Hearing Officer's Conclusions of Law
The
Hearing Officer concluded that nurses Francis and
DeBenedictis engaged in unprofessional conduct by violating
Bd. Reg. 10.4.1, Bd. Reg. 10.4.2.14, and Bd. Reg.
10.4.2.28.[40] Such unprofessional conduct is a basis
for professional discipline according to 24 Del C. §
1922(a)(8). In particular, the Hearing Officer found that Ms.
Francis and Ms. DeBenedictis violated Bd. Reg
10.4.1[41] because they were obligated to exercise
independent judgment and object or refuse to participate in
returning the pills. Furthermore, the nurses were aware of
"standard operating procedure" at JTVCC, that the
pills were to be wasted. Therefore, the return of the pills
to the inmate constituted unprofessional conduct which may
have adversely affected his health and welfare.
The
Hearing Officer also found that Ms. Francis and Ms.
DeBenedictis violated Bd. Reg. 10.4.2.14 because the nurses
acted unethically.[42] The Hearing Officer defined ethical
conduct as "conforming to accepted professional
standards."[43] Therefore, because the return of the
pills to the container did not conform to professional
standards of nursing, Ms. Francis and Ms. DeBenedictis failed
to act "ethically"-in violation of Bd. Reg.
10.4.2.14.[44]
Additionally,
the Hearing Officer concluded that Ms. Francis and Ms.
DeBenedictis violated Bd. Reg. 10.4.2.28.[45] The Hearing
Officer first noted that there was no specific policy or
procedure in place at JTVCC which governed the handling of
non-controlled substances which had been
spilled.[46] Rather, the Hearing Officer concluded
that Ms. Francis and Ms. DeBenedictis failed to take
appropriate action to safeguard the inmate; the nurses failed
to exercise reasonable independent nursing judgment and
preclude the spilled Sovaldi pills from being administered to
inmate after they had been wasted.[47]
As a
result of the violations, the Hearing Officer recommended
that: (1) the Board of Nursing place Ms. Francis' and Ms.
DeBenedictis' nursing licenses on probation for a period
of 90 days; (2) the nurses complete nine nursing education
hours, three each in the subject area of (a) standard of care
pharmacology and drug administration practices in
institutional settings, (b) coordination of authority and
responsibilities of multiple health care providers in
institutional settings, and (c) nursing ethics; and (3) the
final order of the Board constitute public disciplinary
action reportable to public practitioner data bases.
The
parties were given twenty days from the date of the Hearing
Officer's proposed order to submit written exceptions,
comments, and arguments concerning the conclusions of law and
recommended penalty.[48] Ms. Francis and Ms. DeBenedictis
provided written exceptions to the Board. The nurses'
counsel then presented verbal exceptions to the Board during
the Board's meeting on September 14, 2016. Counsel
highlighted the expert testimony, stressed the fact that the
risk to the patient was negligible, argued that the Hearing
Officer's finding that the actions resulted in a
likelihood of harm was not supported by the evidence, and
emphasized that the nurses were acting at the direction of
the medical director and pharmacist.[49]The State responded by
highlighting the facts in evidence.[50] After deliberating, the
Board voted to affirm the Hearing Officer's recommended
conclusions of law and discipline.[51]
III.
THE PARTIES CONTENTIONS
Ms.
Francis and Ms. DeBenedictis contend that the Board's
conclusion lacks "substantial evidence" and
therefore must be vacated.[52] In particular, they argue that
the Board's decision lacked substantial evidence because
(1) the decision discredited the only expert testimony
offered;[53] (2) the Pharmacists and the Medical
director directed the return of the pills and the nurses had
the right to rely upon that directive;[54] (3) there was
no evidence that the nurses should have disobeyed the
directive;[55] (4) the directive presented no risk of
harm to the patient;[56] and (5) imposing discipline upon the
nurses would put them in an impossible
position.[57]
In
response, the State argues that the Board's conclusion is
based on their expertise and analysis of the facts in the
record.[58] The State further argues that the record
contained substantial facts regarding Ms. Francis' and
Ms. DeBenedictis' unprofessional conduct and the
standards in the nursing community.[59]
IV.
STANDARD OF REVIEW
Ms.
Francis and Ms. DeBenedictis appeal an administrative
disciplinary decision of the Delaware Board of Nursing. The
Delaware Administrative Procedures Act ("APA")
vests this Court with jurisdiction to entertain appeals from
an administrative board's final order.[60] The
board's final order must be affirmed so long as it is
supported by substantial evidence and free from legal
error.[61] Substantial evidence is that which a
reasonable mind might accept as adequate to support a
conclusion.[62] While a preponderance of evidence is not
necessary, substantial evidence means "more than a mere
scintilla."[63] The Court takes due account of the
Board's specialized competence and the purpose of the law
under which the Board acted, [64] and does not weigh the
evidence, determine credibility or draw its own factual
findings or conclusions.[65]
Questions
of law are reviewed de novo.[66] If the
Board's findings and conclusions are sufficiently
"supported by the record and are the product of an
orderly and logical deductive process, " its decision
will be affirmed.[67]
V.
DISCUSSION
A. The
Spraga Decision
The
Hearing Officer found Dr. Spraga in violation of 24 Del C.
§ 1731(b)(3) because her failure to overrule the
pharmacists caused a "risk of harm."[68] The Board of
Medical Practice affirmed the Hearing Officer's
recommendation and Dr. Spraga appealed that decision. The
Superior Court, on appeal, found no evidence to support a
finding of public harm.[69] Dr. Spraga's expert witnesses
testified to the absence of public harm, the State presented
no argument of public harm, and the Hearing Officer did not
cite facts that supported a finding of public harm. The
Spraga Court, therefore, concluded that Dr. Spraga
did not violate 24 Del C. § 1731(b)(3).
Dr.
Spraga also appealed the Board's conclusion that she
violated Board Rule 8.1.16-prohibiting "any other act
tending to bring discredit upon the
profession."[70] The Court determined that Dr. Spraga was
not given fair notice and an opportunity to be heard because
the Board conceived her violation post hoc,
privately. Therefore, the Board's conclusion that Dr.
Spraga violated Board Rule 8.1.16 could not
stand.[71] Upon finding no violations the Superior
Court remanded the matter to the Board for proceedings in
light of the rulings therein.
In
light of Spraga Ms. Francis and Ms. DeBenedictis
submitted supplemental briefs arguing that collateral
estoppel requires the nurses' appeal be sustained. The
nurses argue the Spraga court concluded that Dr.
Spraga was not required to overrule the pharmacists.
Therefore, Spraga compels that the nurses were not
required to overrule the pharmacists or the doctor.
Furthermore, the nurses argue that denying the nurses'
appeal would be irreconcilable with the Spraga
...