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Francis v. Delaware Board of Nursing

Superior Court of Delaware

January 23, 2018

CHRISTINE MULRY FRANCIS, Appellant,
v.
DELAWARE BOARD OF NURSING, Appellee. ANGELA L. CALDWELL DEBENEDICTIS, Appellant,
v.
DELAWARE BOARD OF NURSING, Appellee.

          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 ...


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