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Spraga v. Delaware Board of Medical Licensure and Discipline

Superior Court of Delaware

August 7, 2017

LAURIE ANN SPRAGA, D.O., Appellant,
v.
DELAWARE BOARD OF MEDICAL LICENSURE AND DISCIPLINE, Appellee.

          Submitted: May 2, 2017

         Upon Consideration Appeal from Administrative Order. REVERSED and REMANDED.

          Daniel A. Griffith, Esquire and Kaan Ekiner, Esquire, WHITEFORD TAYLOR & PRESTON, LLC, Wilmington, Delaware. Attorneys for Appellant Laurie Ann Spraga, D.O.

          Carla A.K. Jarosz, Esquire, STATE OF DELAWARE DEPARTMENT OF JUSTICE, Wilmington, Delaware. Attorney for Appellee Delaware Board of Medical Licensure and Discipline.

          MEMORANDUM OPINION

          CHARLES E. BUTLER JUDGE

         The State has a legitimate concern for maintaining high standards with respect to physicians practicing medicine within its borders. Physicians have a legitimate interest in maintaining their license in good standing. The State's disciplinary action against the physician in this case, while conducted within a framework designed to assure procedural fairness, fell short of the mark. The Court will therefore reverse the decision below and remand for such further proceedings as the administrative board deems appropriate.

         FACTUAL BACKGROUND

         The facts of this case, as found by the Hearing Officer below, are ugly. Unfortunately, the issues are far too nuanced to respond in knee jerk fashion, despite the temptation to do so. The story is essentially this.

         There was a patient at the Delaware Correctional Center who had hepatitis C and was prescribed a very expensive medication by his infectious disease doctor. When we say "expensive" we mean it; each pill cost $1, 000 and the manufacturer only sold it in lots of 28.

         The administration of this medicine involves some bureaucracy that matters. The Department of Corrections ("DOC") has two vendors that factor in here. Connections Community Support Programs, Inc. ("Connections") provides medical care for DOC patients. DOC has a separate contract with CorrectRX Pharmacy Services, Inc. ("CorrectRx") to run the pharmacy operations for DOC. The actual location we will be discussing in this case is not technically a pharmacy. It is a "medicine room" where medicines are administered to patients.

         Inside these two medical organizations there are a number of actors that play parts in this incident. Connections employed administering nurses Megan Bowerson, Roxanna Gonzalez, nursing supervisor Christine Francis and Director of Nursing Angela DeBenedictis. They were all on site at the James T. Vaughn Correctional Center ("JTVCC") for some or all of the incident to be discussed. Then there is the Respondent Dr. Spraga, who is the Chief Medical Officer for Connections. She was not on site at the time of the incident.

         CorrectRx maintains a pharmacy warehouse in Maryland and delivers medications to the various DOC facilities, including JTVCC. The two employees that figure into this story are Dr. Jamie McGee, a pharmacist located at the prison, and her boss, Dr. Valerie Barnes, located at the corporate office in Maryland.

         As noted above, the infectious disease medication in question - Sovaldi - was quite expensive. The treatment called for the patient to receive 1 tablet per day for 84 days. The manufacturer only sold these tablets in lots of 28, so that 3 containers of the pills was a full regimen. Although the pills are not narcotics, because of their expense, their count and distribution is tightly controlled.

         On March 17, 2015, Nurse Gonzalez was coming off her shift at the JTVCC and was to be replaced by Nurse Bowerson. As required, they counted the Sovaldi tablets and, in the course thereof, Nurse Bowerson spilled 12 of the tablets onto the floor. Employing a bit of advice she says she learned in nursing school, Bowerson "wasted" the pills into the "sharps" container - a box intended for "biohazard" materials. Because this caused the pill count to be 12 tablets fewer than had been previously counted and, because the prescribed course of treatment of the patient required the patient to ingest the 12 pills over 12 days, the pills needed to be replaced quickly.

         Nurse Bowerson contacted the onsite CorrectRX pharmacist, Dr. McGee, to request a refill of the Sovaldi pills. Dr. McGee, in turn, contacted her boss in Maryland, Dr. Barnes. What followed next was the subject of disputed testimony at the hearing, so we will hew closely to the specific fact findings by the Hearing Officer.

         Dr. Barnes (from CorrectRX) contacted Dr. Spraga (the Medical Director for Connections). Dr. Barnes informed Dr. Spraga that the 12 Sovaldi pills had been wasted and "asked Dr. Spraga to arrange for the retrieval of the pills."[1] Dr. Spraga next contacted Nurse Supervisor Francis and told her to retrieve the Sovaldi pills from the sharps container.

          Nurse Francis, accompanied by Director of Nursing DeBenedictis, went to the medication room, located the sharps container, turned it over and shook it until the 12 pills finally fell out. Included in the flotsam and jetsom that came from the container were diabetic syringes with safeties engaged, and an equal number of diabetic test strips and diabetic lancets. There was additional material in the sharps container when it was turned and shaken, but no one knows exactly what it was.

         Next, the Sovaldi pills were brought to Nurse Francis' office where they were inspected by Nurses Francis and DeBenedictis. About this time, Dr. McGee, the pharmacist, responding to a request from her boss, Dr. Barnes, came to Nurse Francis' office and inspected the Sovaldi pills herself. 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 'checked' in a human mouth."[2]

         The state of knowledge about where the pills came from was hotly contested at the hearing. But the Hearing Examiner found as a fact that Dr. McGee knew that the pills she inspected had come from the sharps container. In sum, each of the relevant actors knew they were about to reuse Sovaldi pills that had been wasted in the sharps container. According to the Hearing Examiner's finding, "Dr. Spraga determined to leave to the two pharmacists the decision as to whether the retrieved pills could be administered to the inmate 'as they are the subject matter experts.'"[3]

         The visual inspection having been completed and there having been nothing observed leading the nurses or Dr. McGee to believe the pills had been compromised, the decision was made to place the pills back into the container and make them available for administration to the patient. The Hearing Examiner found, as a matter of fact, that Dr. McGee gave her authorization to return the 12 Sovaldi pills to the bottle.[4] He further found that "Dr. McGee approved the administration to DL of the 12 tablets."[5]

         The Hearing Examiner did not specifically find that it was Respondent Dr. Spraga that ordered the 12 Sovaldi pills back in to circulation. There was certainly testimony, notably from Supervising Nurse Francis, that Drs. Spraga, McGee and Barnes all discussed the fact that the pills had been wasted in a sharps container. A fair reading of the record would conclude that Dr. McGee authorized the recirculation of the wasted pills and that Dr. Spraga assented to that authorization.

         And so it appears that the patient ultimately ingested pills that had been through the sharps container beforehand. The patient was ultimately so advised -several ...


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