If you are a health professional (or health professions student) report of your opinion as an expert witness.

Consider the elements of negligence that you could be the expert for- was there a duty of care? Was that duty breached? Was that breach the cause of harm to the plaintiff? What were the damages?

Be specific and consider the elements of your report- consider what records you would have reviewed before offering your opinion. Be sure to have section for your expert opinion on all four elements of the case for negligence and incorporate your opinion and how the facts support it. How would you frame your opinion? What is the standard? Which profession type are you qualified to opine about?

*6 IV. STATEMENT OF FACTS

Relationships Among the Parties

1. In March, 2015, the State had a contract with Connections Community Support Programs, Inc. ("Connections") for the provision of general, non-specialized medical treatment and contracts with other medical vendors for more specialized treatment, including pharmaceutical services. The different medical vendors are considered partners with each other and with the State as part of a "multi-vendor healthcare system" within which the providers rely upon one another for a coordinated approach to healthcare. (A124).

3. In March, 2015, Correct Rx was the vendor for pharmaceutical services at the Delaware correctional facilities. Dr. Jamie McGee was the clinical pharmacist assigned by Correct Rx to work on-site at the James T. Vaughn Correctional Center ("JTVCC") in Smyrna, Delaware (A92-94). Dr. McGee's direct supervisor at Correct Rx was Dr. Valerie Barnes.

4. Dr. Laurie Ann Spraga, was the statewide medical director for Connections. Ms. Francis, was Connections' Health Services Administrator ("HSA") at JTVCC, responsible for administrative oversight of the Connections' medical staff onsite. Ms. DeBenedictis was the Director of Nursing at JTVCC. The Nurses' Background Training and Experience

*7 5. Ms. DeBenedictis received her nursing degree in 2006. She has worked in the Christiana Care Health System, Delaware Psychiatric Center, in hospice care and, since 2014, correctional health care. (Ms. DeBenedictis' resume as marked as Respondents Exhibit 3 at the hearing. A322). She has held the positions of Patient Care Technician, Nurse-in-Charge, R.N. Case Manager and, in this case, Director of Nursing. Ibid.

6. Ms. Francis received her Licensed Professional Nursing degree in 2010. In 2012, she earned her Registered Nurse degree. She has performed general nursing care, wound treatment and medication administration. (A389-390). Ms. Francis has become a Certified Correctional Health Care Provider and was the Health Services Administrator at JTVCC at all relevant times.

7. The nurses described the relationship between Connections and the pharmacy contractor, Correct Rx as follows:

Ms. Francis:

Q. What would you rely on the pharmacist for, you meaning Connections?

A. I actually relied on Dr. McGee quite often. We attended meetings together several times a week, each week. We discussed patient care regimen. We have hospice patients in the infirmary. We talked about medications, what would be best, not so much prescription, but what would be the best course of action and what she would recommend for the patient.

Q. Did Dr. McGee have expertise in pharmacy that no one else at Vaughn had?

*8 A. Absolutely. (A392-393).

Ms. DeBenedictis

Q. What would be the relationship between your nurses and the pharmacist from Correct Rx?

A. The nurses on a daily basis would utilize the pharmacist for questions in regard to medication, medication for general pharmacy operations, medication returns, medication refusals. Storage of medications.

They worked together closely- the pharmacist would come in and do pharmacy audits and ensure that things were stored appropriately. That things were - we cal them externals and internals - were not stored together.

So there was a lot of interaction between the pharmacist and the nurses. (A323-324).

Q. Would you, as Director of Nursing, and would you expect the people under your supervision to rely on the recommendations from the pharmacist?

A. Absolutely.

Q. Is that because they're specialists in the area and you guys are not?

A. Absolutely. I mean, collaboratively you work as a team. You look to the experts above you who have specialty in those groups to help you out. (A325-326).

March 17, 2015 Incident

8. Most of the essential facts concerning the underlying incident are undisputed. On March 17, 2015, a nurse working in the pharmacy at JTVCC, Megan Bowerson, accidentally spilled twelve (12) Sovaldi pills onto the floor of *9 the pharmacy and thereafter discarded them into a sharps container, noting on a Controlled Substance Usage Report that the pills had been discarded. The on-site clinical pharmacist from Correct Rx, Dr. McGee, notified her supervisor, Dr. Barnes of what had occurred and Dr. Barnes, in turn, notified Dr. Spraga.

9. Dr. Barnes thereafter directed Dr. McGee to have the pills inspected for integrity. Consequently, upon the directive from their Medical Director (Dr. Spraga) Ms. Francis and Ms. DeBenedictis proceeded to the pharmacy, retrieved the pills from the sharps container and presented them to the pharmacist, Dr. McGee, for inspection. Dr. McGee reported to her supervisor, Dr. Barnes, that the pills looked new, "as if they had just come out of the bottle."

10. It was then decided (among Dr. McGee, Dr. Barnes and Dr. Spraga, not by the Nurses) that the pills should be returned to the bottle. Ms. Francis was directed to return the pills to the bottle. The pharmacist, Dr. McGee, accompanied her. Upon returning the pills to the bottle, a note to that effect was made on the Controlled Substance Usage Log.

11. A consolidated hearing on the State's Complaints was conducted on June 15, 2016 and June 16, 2016. The central dispute in advance of the hearing was whether the Correct Rx pharmacists (Dr. Barnes and Dr. McGee) authorized the return of the pills to the bottle or whether, to the contrary, Dr. Spraga and the Nurses disregarded to the recommendations of the pharmacists.

*10 Testimony From 6/15/16 and 6/16/16 Hearing

12. The testimony at the hearing established conclusively that the pharmacists not only authorized and ratified the return of the pills to the bottle, but also that the pharmacists actually participated in their return.

13. The testimony (including testimony from the State's witnesses) also conclusively established that the Nurses were expected and entitled to rely upon the expertise of the pharmacists and their Medical Director with respect to that decision.

14. Because the State had proceeded on the theory that the Nurses acted against the pharmacists' judgment, the State presented no evidence to support the argument that the Nurses had a duty to overrule, or ignore, the pharmacists' directive.

15. The Nurses, in contrast, were prepared to address that issue and presented both fact and expert testimony confirming that: (1) the Nurses were entitled to rely upon the expertise of the pharmacists; and (2) following the course of action directed by the pharmacists presented no risk of harm to the patient.

FDCA:

Sovaldi comes in pill form, and each pill costs $1,000. A full course of the medication is 28 pills, and it can be purchased only in lots of 28. The prison had ordered a course of the medication to treat an inmate and, because of its cost, subjected the medication to the same careful controls it applies to controlled substances, including periodically counting the pills.

Two nurses were conducting one of those counts when one of them accidentally tipped over the bottle of pills, spilling twelve of them onto the floor. Both nurses believed that when medication comes into contact with the floor, it must be discarded, so they collected the twelve pills and disposed of them in a "sharps container"a medical waste container designed for the disposal of skin-piercing objects, like syringes and blades. This decision to discard the pills once they hit the floor was consistent with the testimony of the appellees themselves as to what to do in this situation.9

After disposing of the pills, the nurses notified the pharmacist on duty at the prison (the prison has an on-site pharmacy run by a private company) that a refill of the medication would be needed.

The on-site pharmacist immediately called her supervisor, the head of the pharmacy company's Delaware operations, who in turn contacted the head physician of the separate company that furnishes the prison with patient care. The physician, who was not at the prison at the time, called nurse, Christine Francis, and told her to retrieve the pills from the sharps container.

Francis, the prison's health services administrator, asked nurse Angela DeBenedictis, and the prison's director of nursing, to accompany her. After locating the waste container, the two nurses laid paper towels on a table, unlocked the containerwhich is normally locked until the contents can be safely disposed ofand shook it until all twelve pills had fallen out. Along with the pills came some syringes, retractable lancets, and diabetic testing strips. There was additional medical waste in the container that the twelve pills could have touched, but once all twelve pills fell out, the nurses stopped shaking the container, leaving those materials behind. No one knowsor can knowwhat that waste was.

Francis and DeBenedictis wrapped the pills in a paper towel and took them to their office. There, they were met by the on-site pharmacist, and together, they looked at the pills. To the pharmacist, "there did not appear to be anything wrong with [them]""they looked like they came out of a bottle."

Consistent with the basic examination of the pills themselves, no one checked the floor where the pills had been spilled.

The pills were later given to the inmate. He suffered no ill effects, but he was not told the pills had been retrieved from a medical waste container until after he had taken them. In other words, no one informed the inmate of what had happened to the pills or gave him a chance to give or deny consent or request that he receive pills not retrieved from a medical waste container.

No onenot the nurses, not the on-site pharmacist, not the head pharmacist, and not the head physiciantook responsibility for deciding that the pills were fit for use. Francis, DeBenedictis, and the head physician claimed it had been one of the pharmacists, while the head pharmacist insinuated it had been the head physician. The on-site pharmacist pleaded ignorance.

When one of the nurses who had disposed of the pills in the waste container learned they had been retrieved and given to an inmate, she reported it to the Delaware Division of Professional Regulation. But, what would happen if the inmate brought a law suit?