HospitalInspections.org

Based on staff interviews, review of the hospital analysis and corrective action plan, review of the hospital Quality Improvement Program QIP) and Committee meeting minutes, clinical record review for 3 of 3 sampled infants (#1, 2 and 3), review of hospital Policy and Procedures, the hospital failed to ensure adequate corrective action was taken following a medication compounding error (a process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient) which resulted in the death of infant #1. The hospital QIP failed to address medication compounding for the adult patient, ensure pharmacist oversight in the preparation and dispensing of oral medication and failed to adequately address staffing shortages in the Pharmaceutical department which contributed to a medication compounding error resulting in fetal demise. Interviews with 18 staff members identified ongoing quality concerns related to staffing, policy interpretations and ongoing medication errors (Chief Medical Officer, Chief Executive Officer, Vice President of Regulatory Compliance and Accreditation, Vice President for Administrative Services, Risk Manager, the Director of Pharmacy, the Pharmacy Manager, Pharmacists A, D, J, L, and Pharmacy Technicians B, C, I, P and Q). These failures have the potential to threaten patient safety for all 228 patients in the acute care hospital as well as its two standalone Emergency Departments who receive pharmaceutical services.

The cumulative effect of these failures resulted in a determination of Immediate Jeopardy at the Condition of Quality Assessment and Performance Improvement.

The hospital Vice President of Regulatory Compliance & Accreditation Service and the Risk Manager were notified of Immediate Jeopardy on 04/07/2023 at 08:59 AM. Immediate Jeopardy started on 03/18/2023. The Immediate Jeopardy was ongoing at the completion of the survey.


The findings include:

Cross Reference A0283: Based on staff interviews, review of the Quality Improvement Program (QIP), QIP committee meetings minutes, review of the pharmacy policies and procedures and review of Florida Pharmacy Law (rule 64B16-27.1001, Practice of Pharmacy, Florida Administrative Code), the hospital QIP program failed to fully address the lack of pharmacist oversight during medication compounding (a process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient) and dispensing and Pharmaceutical department staffing shortages when developing corrective actions following a medication compounding error which resulted in the death of an infant. Both hospital policy and Florida State Law require a pharmacist to be physically present and give direction to the pharmacy technician when they are delegated the task of medication reconstitution, for the addition of additives, or for bulk compounding of the parenteral solutions (medications not given orally, typically provided directly into a vein, into a muscle or under the skin by injection). The lack of direct pharmacist oversight during medication compounding and dispensing resulted in medication errors affecting 3 of 3 sampled infants (#1, #2, and #3) who were patients in the Neonatal Intensive Care Unit (NICU) and resulted in the death of Infant #1 who received about 20 times the ordered dose of parenteral potassium phosphate. Infant #2 was ordered to receive Multivitamin with iron but instead received Ferrous Sulfate (Iron) up to 16 times before the error was caught, and Infant #3 was ordered to receive Morphine Sulfate at a titrated dose which was not drawn up correctly by the pharmacy. The hospital investigated and updated processes for NICU and pediatric medication compounding, but failed to address process changes for adult medication compounding. Interviews with 18 staff members (Chief Medical Officer, Chief Executive Officer, Vice President of Regulatory Compliance and Accreditation, Vice President for Administrative Services, Risk Manager, the Director of Pharmacy, the Pharmacy Manager, Pharmacists A, D, J, L, and Pharmacy Technicians B, C, I, P and Q) identified pharmaceutical quality concerns related to low staffing, policy interpretations, ongoing medication errors and that Pharmacy technicians continued to compound and/or prepare high risk medications without the pharmacist being physically present.

Based on staff interviews, review of the Quality Improvement Program (QIP), QIP committee meetings minutes, review of the pharmacy policies and procedures and review of Florida Pharmacy Law (rule 64B16-27.1001, Practice of Pharmacy, Florida Administrative Code), the hospital QIP program failed to fully address the lack of pharmacist oversight during medication compounding (a process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient) and dispensing and Pharmaceutical department staffing shortages when developing corrective actions following a medication compounding error which resulted in the death of an infant. Both hospital policy and Florida State Law require a pharmacist to be physically present and give direction to the pharmacy technician when they are delegated the task of medication reconstitution, for the addition of additives, or for bulk compounding of the parenteral solutions (medications not given orally, typically provided directly into a vein, into a muscle or under the skin by injection). The lack of direct pharmacist oversight during medication compounding and dispensing resulted in medication errors affecting 3 of 3 sampled infants (#1, #2, and #3) who were patients in the Neonatal Intensive Care Unit (NICU) and resulted in the death of Infant #1 who received about 20 times the ordered dose of parenteral potassium phosphate. Infant #2 was ordered to receive Multivitamin with iron but instead received Ferrous Sulfate (Iron) up to 16 times before the error was caught, and Infant #3 was ordered to receive Morphine Sulfate at a titrated dose which was not drawn up correctly by the pharmacy. The hospital investigated and updated processes for NICU and pediatric medication compounding, but failed to address process changes for adult medication compounding. Interviews with 18 staff members (Chief Medical Officer, Chief Executive Officer, Vice President of Regulatory Compliance and Accreditation, Vice President for Administrative Services, Risk Manager, the Director of Pharmacy, the Pharmacy Manager, Pharmacists A, D, J, L, and Pharmacy Technicians B, C, I, P and Q) identified pharmaceutical quality concerns related to low staffing, policy interpretations, ongoing medication errors and that Pharmacy technicians continued to compound and/or prepare high risk medications without the pharmacist being physically present.

The QIP failure to address pharmacy staffing shortages and the requirement for a pharmacist to be physically present and providing oversight when a pharmacy technician performs medication compounding for adult patients has the potential to directly threaten patient safety for all 228 patients in the acute care hospital as well as its two standalone Emergency Departments (ED) who receive pharmaceutical services. Cross Reference A489, A493 and A501.

The findings include:

Summary of errors for Infant #1, #2 and #3, cross reference A493:

A review of the medical record, timeline report and death summary for infant #1 revealed chemistry laboratory results of a low potassium level of 3.1 MMOL/L (millimoles per liter) (Normal range 4 - 6.5 MMOL/L) and a low phosphorus level of 2.9 mg/dL (milligrams per deciliter) (Normal range 4.3-9.3 mg/dL) on 03/18/2023 at 2:15 PM. A physician ordered Potassium Phosphate 3MM/ML (millimoles per milliliter) 0.405 MM with 3.865 ml (milliliters) sodium chloride to infuse 4 ml (milliliters) at 2 ml per hour. Two pharmacists (Pharmacists D and J) performed the dosing calculations based on infant #1's weight and verified the dosing of potassium phosphate. The pharmacists' calculations revealed that infant #1 would receive 0.135 mls of a 3.3 millimole concentration of potassium phosphate (K+Phos) to be diluted with normal saline to infuse a total of four milliliters over two hours to infant #1. On 03/18/2023 at approximately 7:35 PM, resuscitation efforts began for infant #1. A repeat electrolyte lab draw was completed on 3/18/2023 at 7:58 PM, which revealed infant #1's potassium level was critically high, greater than 10 MMOL/L and a serum phosphate level was critically high, greater than 18 mg/dL. A review of the NICU Death Summary revealed infant #1 expired on 03/19/2023 at approximately 3:02 PM. Infant #1 had received approximately 20 times the amount ordered of K+Phos.

A medical record review for infant #2 revealed physician's order for multivitamins with iron (MVI) 0.5 ML mix in a minimum of 5ML feed dated 03/29/2023. Infant #2 received 16 doses of this medication without apparent adverse consequences. The hospital provided a copy of an email dated 04/02/2023 at 8:40 AM, sent by Pharmacy Technician P (Pharmacy Tech P) to the Director of Pharmacy and the Manger of Pharmacy, with a carbon copies (cc) to Pharmacist A, Pharmacist D, and Pharmacy Tech C. The email documented that a nurse suspected the medication in the syringe was not the correct drug. On site pharmacy staff immediately began investigating. The Pharmacy Tech P wrote, " ...after countless comparisons and smell tests, (Pharmacist A) and I are very confident that (the medication in the syringe) was actually ferrous sulfate. While looking through the syringes, many of the syringes were not pulled back to the correct amount." This conclusion was confirmed by Pharmacy Tech C who replied to the email on 04/03/2023 at 6:23 AM stating, "...I've identified that the lot number on the multivitamins with iron that was in question is the lot number from the bottle of ferrous sulfate. This, accompanied with their very different smell and the fact that there is no record of this lot ever being checked, I am certain this is the wrong drug in the syringe. We've only been able to locate 20 of the syringes for this lot." At 7:07 AM, Pharmacy Tech C added, " ...The packaging summary says 200 were made. Leaving 180 missing."

Infant #3: The hospital provided a report dated 03/17/2023 regarding a Morphine dosing error. The report revealed "a near miss" (a near miss is a mistake that is caught before it occurs) reported by NICU staff. The report stated that a NICU Morphine 0.5 ml/0.2 mg (milligram) dose was pulled from the (name of the automated medication dispensing system) to be administered to infant #3. The registered nurse noticed the syringe only had 0.2 ml of Morphine in the syringe."

Staff Interviews regarding errors, process changes and staffing:

On 04/04/2023 at approximately 11:25 AM, the Director of Pharmacy (DoP) was interviewed about the potassium phosphate medication compounding error that occurred on 3/18/23, and resulted in the subsequent demise of Patient #1, an infant. The DoP stated they have changed their process for all NICU (Neonatal Intensive Care Unit) medications, to include pediatric IV (intravenous - provided directly into the patient's veins) products. It is now required for the pharmacist to go in and double check the medications. The DoP stated that they must spell out how to check a product to ensure it is being done the same way. The Pharmacy Tech cannot start doing anything until the pharmacist is standing at the Hood (compounding "hoods" are designed to reduce the risk of airborne contamination during the preparation of sterile products). When they draw up a diluent in a syringe, the Pharmacy Tech puts the syringe down on the hood, so the pharmacist has the ability to physically check the syringe. They do the same process for the additives; the Pharmacy Techs must allow the pharmacist to visually inspect the medications. At that point, all the components used in the hood are tossed away. The product and label are signed off in the IV room and the final products are passed through the window to be sent up (to the patient unit). She stated she has spoken with each pharmacist and all staff have read and signed they understand and will comply with the changes. The DoP stated that all NICU medications are considered high risk. They had cameras in the IV room, but they were nonoperational. They are now operational, and the hospital has installed a camera in the hood so that a "live feed" of the compounding process can be observed; mainly for the benefit of the graveyard (night shift) pharmacist, since there is just one of them. She stated that the process for compounding of medications, to include high risk/critical medications for adults has not changed. She stated many of adult medications are compounded at the bedside, using a vial they they snap together because they have vials in the automated medication dispensing system and bags in the storeroom. The DoP stated that the majority (about 95%) of compounding in the IV room is pediatrics/neonatal and confirmed that Pharmacy Techs continue to compound high risk/critical medication for adults in the IV compounding room without the physical presence of a pharmacist.

On 04/04/2023 at approximately 12:00 PM, an interview was conducted with Pharmacist D who spoke of her previous hospital employment experience and the differences compared to working here. Pharmacist D stated a lot of the processes are mimicked to other hospitals, however, one difference identified was the lack of a dedicated pharmacist in the IV (intravenous) room. As a result of the event on 03/18/2023, the hospital changed their IV compounding process for the Pediatric/Neonatal intensive care unit (NICU) population. Pharmacist D stated "(the process) we have now is the most effective way to prevent something like that from happening." The new process requires that a pharmacist be physically present, standing at the compounding hood, to observe the Pharmacy Tech while compounding the ordered medication(s). This new process will allow the pharmacist to directly visualize and physically examine the contents, the vial(s) and the amount of medication in each syringe or bag. Pharmacist D, stated "I do think having a pharmacist in the room would have prevented the mistake from occurring." Pharmacist D expressed surprise that the new process did not include critical medications compounded for adults and stated "I would like to see that, honestly, for all critical meds [medications], adults too." Pharmacist D recalled the events from 03/18/2023, stating she was the "only pharmacist in the main pharmacy." There was a Pharmacy Tech already in the IV compounding room when the medication order was received. Pharmacist D stated it was busy. I was answering phones; had a patient getting ready to discharge that needed a medication review; and was calculating and recalculating the amount of medication (an electrolyte) and diluent needed for patient #1. This was done repeatedly based on the infant's dry weight. Pharmacist D stated she even had the Pharmacy Tech calculate the amount and she got the same calculation, showing her, by holding up the calculator, so she could see the result displayed on the calculator screen through the window. The compounded medication was withdrawn into a syringe by the Pharmacy Tech. Pharmacist D stated she was not able to see the medication compounding process, as the Pharmacy Tech "had her back to me" because IV compounding takes place under the compounding hood (hoods are designed to reduce the risk of airborne contamination during the preparation of sterile products). Once the medication was compounded, Pharmacist D stated she was able to perform a verification, based on the labels, it is labeled with the medication(s), amount and volume. Pharmacist D stated she also does a visual inspection of the vials.

Pharmacist D went on to state that the new process was specific to pediatric/neonatal intensive care unit (NICU) patients who are ordered medications that require IV compounding (a process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient). She stated the process has not changed for the adult patient requiring IV compounded medications. Pharmacist D identified that pharmacy technicians compound high risk medications for the adult patients which includes medications such as heparin (an anticoagulant) and paralytics (powerful muscle relaxants used to prevent muscle movement during surgical procedures). The pharmacist stated since the event that occurred on 03/18, the pharmacy has not implemented the same changes for adult IV medication compounding. Pharmacist D was asked about the term "physically present", and replied, "A pharmacist needs to be standing right there next to the tech (technician) when compounding."

An interview was conducted on 04/05/2023 at approximately 7:15 PM, with Pharmacist A who stated he was on duty on the night shift when the iron sulfate and multivitamin error was brought to his attention. Pharmacist A stated the house supervisor came into the pharmacy and had a concern that one of the syringes in NICU "did not have the correct multivitamin in it." Pharmacist A stated, "We just started getting a new version of iron in the pharmacy. There is a distinct smell to the iron. It is a sweet smell". Pharmacist A stated that Pharmacy Tech P was also working with him on the night shift that night. Pharmacist A stated that after the report of a possible error, Pharmacist A and Pharmacy Tech P removed all of the possible incorrect syringes from the (name of the automated medication dispensing system). "I reported the error to the Director of Pharmacy and the Pharmacy Manager." Pharmacist A stated that he was the only pharmacist at night in the main pharmacy. Pharmacist A stated, "It is almost a norm for me to be by myself. I know they have another position approved. Hopefully, that will make a difference".

An interview was conducted on 04/05/2023 at approximately 7:40 PM, with Staff Member B, a Pharmacy Tech who stated she was in the IV room and compounded the potassium phosphate on 03/18/23. Pharmacy Tech B stated, "I had made a NICU Total Parenteral Nutrition (TPN) shortly before and potassium was one of the medications that had been used for the NICU TPN." Pharmacy Tech B stated the same potassium vial that had been used for the NICU TPN was still in the IV compounding area in the workspace. Pharmacy Tech B stated saline vials for admixture are kept in the ante room of the IV compounding area. Pharmacy Tech B stated she was informed of the medication error the next morning when she came to work. Pharmacy Tech B stated she did use the same single dose vial of potassium phosphate that was used for the NICU TPN. Pharmacy Tech B stated the pharmacy protocol allowed them to use single dose vials after the first use, "if they're still in the hood." Pharmacy Tech B stated the vials of medications for single dose use are "good for six hours." Pharmacy Tech B stated that before the K+Phos medication error there was never a pharmacist in the IV compounding room with the staff but reported, "now a pharmacist is to come in and double check the syringes for the NICU patients". Cross Reference A493 for full interview regarding incident.

On 04/04/2023 at approximately 2:30 PM, an interview was conducted with Pharmacy Tech I who described the process for entering the IV compounding room and stated the new process in place is "that a pharmacist is present at the compounding hood when pediatric medications are compounded." She stated that the process for adult medication compounding has not changed and that a pharmacist does not need to be present. She confirmed that high risk medications for adults, including paralytics, are drawn up without the physical presence of a supervising pharmacist.

On 04/04/2023 at approximately 3:45 PM, an interview was conducted with Pharmacist J who 10 hour shifts and works 7 days on and then has 7 days off. She stated on the weekends she works in the main pharmacy from 5:00 PM to 9:00 PM. "I am the only pharmacist in the main pharmacy from 5:00 PM to 8:00 PM." Pharmacist J stated before she came to work here, she was not much involved in the IV compounding process because there was an IV room pharmacist. They would stay in the IV room all day long and it was easy for them to check things. They were physically able to watch pediatric compounding." Here, before this event, "we [a pharmacist] didn't go into that [IV] room." "We didn't watch the tech [technician] draw things up," "we only went into the IV room to check TPN (total parenteral nutrition)." "Now we are required to be in the IV room to observe the Pharmacy Technician when compounding IV medications for the Pediatric/NICU patient. Currently, we are not required to observe IV medication compounding for high risk/critical medications for the adult patient." Pharmacist J stated that physically present means to her, "in the IV room as they [pharmacy technician] drew it up".

On 04/05/2023 at approximately 10:19 AM, an interview was conducted with Pharmacist L who stated she rotates and works in the main pharmacy at least 1 week a month. Pharmacist L stated she would have someone else working with her until 5:30 PM and then be by herself in the main pharmacy (only pharmacist) until 8:30 PM. She confirmed that IV medication compounding can take place during that time performed by the Pharmacy Tech. Pharmacist L described some of her duties to include answering phone calls, verifying orders that COE (centralized order entry) pharmacist couldn't do, call physicians for problems, cover (computer software) alerts related to drug interactions and laboratory results. She stated that she also signs anything that has to go out to the floor, to the automated medications system, and anything out of the IV room. Pharmacist L confirmed, prior to the 3/18 event, she was not present in the IV room when medications were compounded. When asked how she could verify the dose and medication if she was not present, she stated, "To be 100% honest, I have questioned that since day one. We had an IV room pharmacist all the time, there was never a time when there wasn't a pharmacist (IV pharmacist) [referencing previous experience]." Pharmacist L stated she questioned it here and was told "that is how things are, have been and we don't have staff." Since the event, the process for medication compounding for the Pediatric/NICU population has changed and a pharmacist must be physically present watching the medication compounding process. If a pharmacist is not available a "live feed" camera has been installed in the compounding hood to allow the pharmacist to visualize and verify the medication compounding process. Pharmacist L stated she was told that this was "just for pediatric stuff," not the adult compounding process. She stated she has been "disappointed in the lack of response in management on how they handled this" and "there was no formal training or education provided, just our Daily Huddles (brief staff meetings conducted daily)". Pharmacist L stated that Risk Management came in with Division (executive staff) about a week ago to speak during "Daily Huddle" about the plan we were going to do going forward. A laminated sheet was sent out with the new process and discussed briefly at huddle. She stated there was "a group of 4 or 5 of us that pushed them into doing this [process]." "I didn't think it was going to change unless we pushed." Staff Member L stated "we have been severely unstaffed. Management's response [is] to not jump in and help, in my previous experience, management has always helped. I voiced my concerns about this. I was met with "it would be a patient safety concerns because I haven't practiced pharmacy in so long". If you're my direct supervisor you should be able to help." Pharmacist L stated they were down a graveyard pharmacist and they had someone able to cover until the middle of April, but stated after that she was told instead of more help, "you can work extra or over-time." Pharmacist L complained of a lack of communication as well, stating there was an error that was identified this past weekend with a mix-up of syringes containing liquid multivitamin (MVI) and ferrous sulfate (iron supplement) that had not been addressed with staff. Pharmacist L stated that "Physically present" means going into the IV room and seeing the things that are going on and compounded."

On 04/05/2023 at approximately 11:00 AM, an interview was conducted with the Chief Medical Officer (CMO) who stated he is part of the organizational structure and oversees Quality, clarifying "anything that is a quality issue, I work hand-in-hand with Administration." The CMO went on to state that if there was a complaint related to a quality, process or procedure issue, "depending on urgency can be escalated to their Executives (Chief Operations Officer or Chief Nursing Officer)." He stated that as far as staffing, since COVID [we] have been "burning the candle at both ends in almost every service-line." The CMO was asked to review the policy "Scope of Services - Pharmacy," regarding his interpretation of "physically present". He stated it would be 2 people in the sterile compounding room, one providing direct supervision.

On 04/05/2023 at approximately 11:50 AM, an interview was conducted with the Pharmacy Manager who is also a member of the Medical Safety Committee, and is under the supervision of the Director of Pharmacy. The Pharmacy Manager confirmed the IV medication compounding process has changed for pediatrics. The Pharmacy Manager stated, "Anytime pediatric anything, the pharmacist will go in and will talk out with the technician; kind of like a "timeout" for surgery - that's how I laid it out for the team." "Stop - look at the label, we have this drug, does it match the label, everything is timed out. Before you even touch a syringe or needle, we are verifying everything. We verify everything we have in front of us and are to make 1 product at a time." The Pharmacy Manager voiced concerns about "pulling up oral medication." Stating "Our area is small. The sheer amount of volume that we have to provide for the pediatric patient is substantial." "We don't have a good system in place for other oral medications. We need a bigger area. We need more staff." The Pharmacy Manager identified that "pediatrics is 90% of our labor in the pharmacy," and we have scanned over "4600 units in the last 3 months for pediatrics." "The sheer volume we compound is remarkable, would not be out of reason to have a dedicated pharmacy technician and pharmacist in there [IV room]." The Pharmacy Manager identified a "skeleton group" [the smallest number of people needed to keep a business or organization operating] working on the weekends and added that there is 1 pharmacist that comes in at 6 AM, 1 pharmacist at 7 AM, a NICU pharmacist that works 7:00AM to 5:00 PM that does rounds and assessments before coming back to the main pharmacy, and an ED (Emergency Department) pharmacist who comes on at 10:00AM and works until 9:00 PM, does rounds and then comes up to the main pharmacy, indicating around 4:00 PM. The ED pharmacist then works alone until the graveyard pharmacist comes in at 8:00 PM. The graveyard pharmacist works alone until the next morning. The Pharmacy Manager attributes more medication errors with low staffing. The Pharmacy Manager was asked for the interpretation of "physically present" as written in hospital policy "Scope of Services - Pharmacy." The Pharmacy Manager stated, "standing in the IV room."

On 04/05/2023 at approximately 3:40 PM, a follow-up interview was conducted with the DoP regarding pharmacy staffing. The DoP stated they have had 16 FTE (full-time equivalents) for the past 10 years. The DoP confirmed that volume and acuity has increased. She stated in 2013 the hospital was designated from a Level 2 NICU to a Level 3 NICU and that was when services went to 24 hours/7 days a week. The babies in NICU are a higher acuity. The DoP states she just got approved for 2 additional FTEs, so we will have 3 GY (graveyard) pharmacists, when the positions are filled. In the end she would like to have 2 pharmacists and 2 pharmacy technicians on the GY shift. Currently we have 1 pharmacist and 1 pharmacy technician. The DoP stated that on weekends we normally have 7 total pharmacy technicians, 2 stocking the (name of the automated medication dispensing system) , 1 runner in the morning, 1 runner in the evening, 1 IV Technician in the morning and 1 IV Technician in the evening and a graveyard (GY) technician, an opening pharmacist, a mid-day pharmacist, a NICU pharmacist, an evening pharmacist and GY pharmacist.

The DoP confirmed an error in the preparation of oral MVI (multivitamin) and ferrous sulfate (iron supplement) was discovered over the weekend. She stated, "there was a technician drawing up MVI and they grabbed a bottle of plain iron; they look very similar, they are the same color. So, when the compounding error took place, I'm not sure - it could have been compounded on a Friday. They (the pharmacy technician) had drawn from the iron bottle but labeled it as MVI. I couldn't tell you if the pharmacist checked it. The DoP says it was 200 syringes drawn up - some with MVI and some with Ferrous Sulfate, but all were labeled with MVI. She states that after the medications have been compounded a "pick sheet" is put on top of the tote for the pharmacist to check. I don't think a pharmacist laid eyes on those [syringes] before the Pharmacy Tech bagged those up to be distributed and stocked in pharmacy and in the (name of the automated medication dispensing system) machines. The pharmacist uses the "pick sheet" to verify the medication, amount and then signs off with their initials. We were not able to locate that particular "pick sheet", so I don't know which pharmacist was involved. We implemented in our huddle a new oral compounding log and on there is a precheck. All of the syringes were removed and replaced. The neonatologist was informed and there was no impact to the patients."

On 04/06/2023 at approximately 8:55 AM, an interview was conducted with Pharmacy Tech C who stated she "honestly believes that this error (K+Phos on 03/18) occurred because of being short staffed." "I am a graveyard technician and I work in the IV room, I work everything. We are getting contractors in the middle of the month; but have been working alone for a couple of months. I think it will help and make me feel better having someone else there. I'm usually not fallible. I encourage them to question me or if they ever doubt anything [referring to the pharmacists]." At night I am the "end all be all tech." They are working on getting a second pharmacist technician and pharmacist. Again, this all goes back to being short-staffed. The idea of getting a camera over the compounding hood was pitched by one of the other pharmacy technicians and this just got implemented. She stated, "I can't tell you the last time we've been fully staffed, and I've been here for 8 ½ years. In July we lost a tech [technician] and another in September. We are down more than that now. I along with another pharmacy technician have worked 10 days on 4 days off for months." Pharmacy Tech C stated, "The volume in the pharmacy has increased, we have 2 freestanding Emergency Departments, in January the rehab unit opened, and 4 North opened some time last year." She continued, "we have fewer techs and the capacity has gone up by almost a third. I'm very hopeful with this change in management things will get better."

On 04/06/2023 at approximately 3:30 PM, an interview was conducted with the Vice President for Administrative Services. The Vice President stated she was over the pharmacy department, and confirmed there have been staffing concerns stating, "As with healthcare across the country, finding good healthcare professionals is tough and even harder for pharmacy because of specific level expertise." She stated they have 1 pharmacy GY (graveyard) position opening and 3 pharmacy technician position openings, and one very recently hired. The Vice President stated that even though they are short of staff, it "doesn't mean we haven't had the coverage." She stated the hospital has utilized contract staff and are actively recruiting and interviewing. "We are not going to hire any staff just to fill a position. We have used our sister hospital for staff when needed." The Vice President stated that the hospital was aggressively recruiting and that services have to continue, and staff are working really long hours. The Vice President stated that they did did get contract staff approval and have been able to fill 1 pharmacy technician position. When questioned regarding the current number of FTE (16) now versus 10 years ago (being the same) she stated that 10 years ago they had medication carts with pulled drawers and individual drawers that had to be filled, so much of that has changed and become automated. "I'm not saying we don't need our positions filled because if all of our positions were filled we would be in a much more comfortable position, but the functions back then are not the same as the functions now."

On 04/06/2023 at approximately 6:50 PM an interview was conducted with Pharmacy Tech P who stated her duties included maintaining the surgical department and the (name of the automated medication dispensing system) and all machinery to include fully maintaining the stocking and outdates. They are expected to do the adult cartfill, receive warehouse orders for the next shift to deliver, and also do basic duties such as answering the phone, triaging calls, talking to nurses and, "now with only 1 technician they are making all the IVs on the set, regardless with what else needs to be done. The amount is literally endless". Pharmacy Tech P confirmed there were changes made after the potassium phosphate incident (on 3/18) but couldn't state them exactly. She stated she knows an email was sent out, and it was intended for a pharmacist to oversee the preparation of medication and there should be a second pharmacist to verify. At night it is different because they only have one pharmacist and one technician. Pharmacy Tech P went on to state that they installed a camera system over the compounding hood, so the pharmacist can watch through the camera system. She confirmed this was being done on the GY shift. She stated she has never compounded potassium phosphate and feels it is inappropriate that a Pharmacy Tech is ever drawing that up. She stated that electrolytes in general are not used often, so not really a standard set, but that is when you need additional safety checks. Pharmacy Tech P stated she was the technician that was involved in discovering the MVI and ferrous sulfate syringes over the weekend. She said around 11:00 PM, the house supervisor brought over a syringe from NICU. The syringe in question was a dose that did not look and smell right to the nurse. She stated iron has a particular smell and it didn't smell like iron. She looked at the syringe and pulled out what it was supposed to be from stock and the color and smell were off. She stated this syringe had to be MVI. She immediately pulled all the syringes from all the (name of the automated medication dispensing system) machines and what was remaining in the pharmacy bins. Some of the syringes contained straight ferrous sulfate and other contained MVI. With the pharmacist on duty watching, we redid all the syringes. She states they were not able to initially find the "pick sheet" for this medication, but it has since been located and was compounded on Friday 03/03/2023. The error was discovered on 04/01/2023. "Since then, I've created an oral compounding log and checklist."

When asked about staffing, Pharmacy Tech P stated that staffing has been an issue since she came in as a "traveler." (a traveler is a contracted staff member employed by a staffing agency to temporarily fill open/vacant positions). She stated that she feels most of the problems would be fixed if there was enough pharmacy staff and felt the pharmacy staff were "stretched too thin which leaves cracks that we can't catch." She went on to state, "We used to be fully staffed on graveyard, but 2 staff members left within a month of each other and [it] has been that way since. We've had some turn-over [of staff]. We've still not gotten any more coverage. There are 2 travelers coming for 13 weeks in April to provide relief". When asked about working overtime she stated, "Yes, I work a lot of overtime. We are working more hours and I have worked later than my shift every single day this week. By my 4th da

Based on staff interviews, review of hospital analysis and corrective action plan, review of Pharmacy Staffing schedules and review of hospital policies and procedures, the hospital failed to ensure corrective action was taken to address medication compounding for adult patients, failed to ensure pharmacist oversight in the preparation and dispensing of oral medication preparations in accordance with their own policy and Rule Chapter 64B16-27.1001 of the Florida Administrative Code, and failed to adequately address staffing shortages in the Pharmaceutical department which contributed to a medication compounding error resulting in subsequent fetal demise.

The cumulative effect of these failures resulted in a determination of Immediate Jeopardy at the Condition of Pharmaceutical Services. The facility's failure to comply with Rule Chapter 64B16-27.1001, Practice of Pharmacy, of the Florida Administrative Code; and identify the significance of low staffing in the pharmaceutical department contributed to the pharmacy department's medication errors and effective pharmacy supervision resulting in additional medication errors and the likelihood of further serious adverse medication outcomes.

The Vice President of Quality and Regulatory Compliance and the Risk Manager were notified of Immediate Jeopardy on 04/07/203 at 08:59 AM. The Immediate Jeopardy started on 03/18/2023 and was ongoing at the time of survey exit.


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The findings include:

Cross Reference A493: Based on staff interviews, record reviews, and policy reviews, the hospital failed to ensure there were sufficient numbers of pharmacy personnel to provide accurate and safe medication preparation, supervision, and dispensing to meet the pharmaceutical needs of the hospital. This failure resulted in medication errors affecting 3 of 3 sampled infants (#1, #2, and #3) who were patients in the Neonatal Intensive Care Unit (NICU) and resulted in the death of Infant #1 who received about 20 times the ordered dose of potassium phosphate. Infant #2 was ordered to receive Multivitamin with iron but instead received Ferrous Sulfate (Iron) up to 16 times before the error was caught, and Infant #3 was ordered to receive Morphine Sulfate at a titrated dose which was not drawn up correctly by the pharmacy. Interviews with 13 staff members (Vice President of Regulatory Compliance and Accreditation, Risk Manager, Vice President for Administrative Services, the Pharmacy Manager, the Director of Pharmacy, Pharmacists A, D, J, L, and Pharmacy Technicians B, C, P and Q) identified pharmaceutical quality concerns related to low staffing, policy interpretations and ongoing medication errors. The interviews revealed that Pharmacy Technicians were compounding and preparing high risk medications and stocking the hospitals automated medication dispensing system without direct pharmacist oversight secondary to low staffing.

Cross Reference A501: Based on staff interviews, clinical record review, review of death report, review of the Quality Improvement Program (QIP) corrective action plan, review of the hospital policies and procedure and review of Florida Pharmacy Law (rule Chapter 64B16-27.1001, Practice of Pharmacy, Florida Administrative Code), the hospital failed to follow hospital policy and Florida State Law regarding the preparation, dispensing and compounding of medications (a process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient). Both hospital policy and Florida State Law require a pharmacist to be physically present and give direction to the pharmacy technician when they are delegated the tasks of medication reconstitution, for the addition of additives, or for bulk compounding of the parenteral solutions (medications not given orally, typically provided directly into a vein, into a muscle or under the skin by injection). The lack of direct pharmacist oversight during medication compounding and dispensing resulted in medication errors affecting 3 of 3 sampled infants (#1, #2, and #3) who were patients in the Neonatal Intensive Care Unit (NICU) and resulted in the death of Infant #1 who received about 20 times the ordered dose of parenteral potassium phosphate. Infant #2 was ordered to receive Multivitamin with iron but instead received Ferrous Sulfate (Iron) up to 16 times before the error was caught, and Infant #3 was ordered to receive Morphine Sulfate at a titrated dose which was not drawn up correctly by the pharmacy. The hospital investigated and updated processes for NICU and pediatric medication compounding, but failed to address process changes for adult medication compounding. Interviews with 13 staff members (Chief Medical Officer, Vice President of Regulatory Compliance and Accreditation, Risk Manager, the Director of Pharmacy, the Pharmacy Manager, Pharmacists A, D, J, L, and Pharmacy Technicians C, I, P and Q) identified pharmaceutical quality concerns related to low staffing, policy interpretations, ongoing medication errors and that Pharmacy technicians continued to compound and prepare high risk medications without the pharmacist being physically present.

Based on staff interviews, record reviews, and policy reviews, the hospital failed to ensure there were sufficient numbers of pharmacy personnel to provide accurate and safe medication preparation, supervision, and dispensing to meet the pharmaceutical needs of the hospital. This failure resulted in medication errors affecting 3 of 3 sampled infants (#1, #2, and #3) who were patients in the Neonatal Intensive Care Unit (NICU) and resulted in the death of Infant #1 who received about 20 times the ordered dose of potassium phosphate. Infant #2 was ordered to receive Multivitamin with iron but instead received Ferrous Sulfate (Iron) up to 16 times before the error was caught, and Infant #3 was ordered to receive Morphine Sulfate at a titrated dose which was not drawn up correctly by the pharmacy. Interviews with 13 staff members (Vice President of Regulatory Compliance and Accreditation, Risk Manager, Vice President for Administrative Services, the Pharmacy Manager, the Director of Pharmacy, Pharmacists A, D, J, L, and Pharmacy Technicians B, C, P and Q) identified pharmaceutical quality concerns related to low staffing, policy interpretations and ongoing medication errors. The interviews revealed that Pharmacy technicians were compounding and preparing high risk medications and stocking the hospitals automated medication dispensing system without direct pharmacist oversight secondary to low staffing.

The hospital-wide pharmaceutical staffing and oversight failures have the potential to directly threaten patient safety for all 228 patients in the acute care hospital as well as its two standalone Emergency Departments (ED) who receive pharmaceutical services. Cross Reference A501, A489 and A283.

The findings include:

Potassium phosphate (K+Phos) Concern - Infant #1:

A review of the medical record for infant #1 was conducted and revealed the infant was a one month and 14-day old female infant with a complicated history born at 27-weeks' gestation via Caesarean section due to maternal preeclampsia (a pregnancy complication marked by high blood pressure and presence of proteins in urine). Infant #1 had diagnoses to include 27-week premature newborn, need for observation and evaluation of newborn for sepsis (infection of the blood stream), hypoglycemia (low blood sugar), apnea (cessation of breathing) of prematurity, heart murmur, late onset of neonatal sepsis, anemia (deficiency of healthy red blood cells) of prematurity, respiratory distress syndrome, alteration in nutrition of newborn, hyperbilirubinemia (high level of bilirubin in the blood), bowel perforation, hypotension (low blood pressure) in newborn, thrombocytopenia (too few platelets), infection due to Enterobacter Aerogenes, and hyperkalemia (high level of potassium).

On 4/4/23 at approximately 10:30 AM, the hospital's Vice President of Quality, Regulatory Compliance and Accreditation Services provided a copy of the hospital's timeline of events related to the hospital's review of infant #1's medical record. The timeline review revealed infant #1 needed surgery on 03/01/2023 related to worsening abdominal distention with skin discoloration and increased metabolic acidosis. Infant #1 was taken to the operating room for an exploratory laparotomy (a surgical incision into the abdominal cavity) which revealed a necrotic (death of body tissue) small bowel. Infant #1 underwent a small bowel resection with the creation of an ileostomy (an opening into the ileum, part of the small intestine) and mucous fistula (a surgically-formed connection between bypassed colon and the skin surface). On 03/17/2023 infant #1 had an abdominal ultrasound related to ongoing third-spacing (movement of bodily fluid from the blood into the spaces between the cells) of fluid and evidence of inflammation. The ultrasound revealed the presence of an intra-abdominal abscess, which was drained by interventional radiology.

A review infant #1 of the blood chemistry results (labs) dated 03/18/2023 at 2:15 PM revealed a low potassium level of 3.1 MMOL/L (millimoles per liter) (Normal range 4 - 6.5 MMOL/L) and a low phosphorus level of 2.9 mg/dL (milligrams per deciliter) (Normal range 4.3-9.3 mg/dL). A physician order dated 3/18/23 at 5:00 PM for Potassium Phosphate 3MM/ML (millimoles per milliliter) 0.405 MM with 3.865 ml (milliliters) sodium chloride to infuse 4 ml (milliliters) at 2 ml per hour. Two pharmacists (Pharmacists D and J) performed the dosing calculations based on infant #1's weight and verified the dosing of potassium phosphate. The pharmacists' calculations revealed that infant #1 would receive 0.135 mls of a 3.3 millimole concentration of potassium phosphate to be diluted with normal saline to infuse a total of four milliliters over two hours to infant #1.

On 03/18/2023 at approximately 7:35 PM, resuscitation efforts began for infant #1 including chest compressions. Infant #1 had worsening hypoxia (low blood oxygen levels) and required mechanical ventilation. A repeat electrolyte lab test was completed on 3/18/2023 at 7:58 PM, which revealed infant #1's potassium level was critically high, greater than 10 MMOL/L and a serum phosphate level was greater than 18 mg/dL.

Further review of the timeline revealed that on 03/18/2023 at approximately 8:40 PM, the hospital's pharmacy department was contacted to report that infant #1 was "critically ill and close to coding (requiring resuscitation) due to hyperkalemia (a potassium level greater than 5 MMOL/L)". A pharmacist from the main pharmacy department reviewed infant #1's lab results which revealed a critically high potassium level (Potassium greater than 10). The pharmacist reviewing the lab could not figure out how the infant's potassium level was that high because the order for potassium phosphate had been calculated and dispensed and verified by two pharmacists (Pharmacists D and J). During this time, the pharmacist at the infant's bedside realized there was a strong possibility that the medication vials containing the medication potassium and phosphorus had been switched with the dilution medium normal saline.

On 03/19/2023 at approximately 12:30 AM, the parents of infant #1 were at the bedside. The provider disclosed the medication error to the parents of infant #1 at that time.

The timeline identified that on 03/19/2023 at approximately 2:40 PM, infant #1 became bradycardic (heart rate below 100 beats per minute for premature infants). The provider informed the parents of infant #1 of the "grave prognosis".

A review of the NICU Death Summary revealed infant #1 expired on 03/19/2023 at approximately 3:02 PM. Hyperkalemia appeared last on the list of diagnoses with a date of onset of 3/18/23. Under the comments: "resuscitation for Hyperkalemia persisted Potassium > (greater than) 10-8.2 despite multiple attempts to decrease level by all routine means available to do so. Hypotension and anuria were not amenable to treatment. 3/18/23 at 1930 (7:30 PM) Coded infant following K+Phos bolus (a single dose of potassium phosphorus given by infusion into a blood vessel) which the baby was found to have received approximately by report 20 times the amount ordered".

An interview was conducted on 04/05/2023 at approximately 7:40 PM, with Staff Member B, a Pharmacy Technician (Pharmacy Tech) who stated she was in the IV room and compounded the potassium phosphate on 03/18/23. Pharmacy Tech B stated, "I had made a NICU Total Parenteral Nutrition (TPN) shortly before and potassium was one of the medications that had been used for the NICU TPN." Pharmacy Tech B stated the same potassium vial that had been used for the NICU TPN was still in the IV compounding area in the workspace. Pharmacy Tech B stated saline vials for admixture are kept in the ante room of the IV compounding area.

Pharmacy Tech B stated, "I had to wait for Pharmacist D to give me the label with the calculation. So, when she finally got me the label, she wanted me to calculate also to make sure that we came up with the same amount. So, I calculated the medication and wrote it on the label and flipped it so she could see through the window the amount that I had written down. When I got her okay that it was the amount that I had come up with and matched her amount, I went ahead and re-sterilized myself and got in the hood (the compounding "hood" is designed to reduce the risk of airborne contamination during the preparation of sterile products). I had taken a one cubic centimeter (cc) syringe and a five cc syringe. I wiped off the vials and used an Insulin syringe to pull up 0.133 milliliters (mls) of the Potassium Phosphate (K+Phos) and set the vial to the side. I then took the five cc syringe and pulled up the 3.9 cc's of saline. I then took the 0.1 ml of K+Phos and shot it into to the five cc syringe. So, the total amount was four cc's. I took the four milliliters, capped it, signed off on the label, and put it in the window. Pharmacist D got it and double checked the amount and the calculations. She checked the vials and then waited for the Emergency Room (ER) pharmacist to come up so she could double check behind her and do her own calculations. There was no one in the IV room with me."

Pharmacy Tech B stated she was informed of the medication error the next morning when she came to work. Pharmacy Tech B stated then she received a text message from the Director of Pharmacy later that day informing her that infant #1 "had passed".

Pharmacy Tech B stated, "I'm still a little confused because I had used a number of saline vials that day. The two vials are completely different in shape. I pulled up the potassium phosphate first and I sat it on the side. If you go in and watch any cameras of me making any kind of medication you will see that when I pull something up, I set it to the side. It's not even straight directly in front of me. Then I took the five ml syringe and pulled the saline up out of that. After I had the amount I needed, then I put the K+Phos into that. The amount came up to the four CC's total."

Pharmacy Tech B stated she did use the same single dose vial of potassium phosphate that was used for the NICU TPN. Pharmacy Tech B stated the pharmacy protocol allowed them to use single dose vials after the first use, "if they're still in the hood." Pharmacy Tech B stated the vials of medications for single dose use are "good for six hours."

Pharmacy Tech B stated that before the K+Phos medication error there was never a pharmacist in the IV compounding room with the staff but reported, "now a pharmacist is to come in and double check the syringes for the NICU patients".

Pharmacy Tech B stated, "We've been shorthanded forever. We've been shorthanded for years. We are rarely fully staffed. We get texted every day. And usually, we do not have enough techs to man all those positions. So, one or two techs have to finish their job and then jump in to do another one of the other positions. We almost always don't have enough people to do the unit dose person's job". Pharmacy Tech B stated the "unit dose person" is a staff member that will complete the pre-packing of medications including powders, ointments, and tablets. Pharmacy Tech B stated, "We all have to pitch in and do more than our job to complete the day. And on the weekends, on my shift, we're even shorter. We don't have the unit dose person. We also have to put the orders away in the morning. We do quite a bit of extra work other than just our plain shifts. We also now have to pull (name of the automated medication dispensing system) every Saturday and Sunday. That's an extra added job that we're having to do".

An interview was conducted on 04/06/2023 at approximately 9:45 AM, with Pharmacy Tech C who assisted with the investigation of the K+Phos error. Pharmacy Tech C stated the normal saline vial involving the K+Phos medication error "did not appear to be punctured". Pharmacy Tech C stated, "But when you use an insulin needle, there is no mark. We tested that as well. We punctured the saline vial with an insulin needle. When you puncture a vial, you can't tell because the needle is so incredibly small. But I know I could see that the potassium phosphate vial had three puncture wounds (sic). I showed Staff J, Pharmacist. When I pulled out the final volume of the potassium phosphate there was about eleven milliliters remaining in that vial. There was 10.5 milliliters in the normal saline vial when I pulled the fluid out".

Pharmacy Tech C stated that she got new vials of K+Phos and saline, with matching lot numbers and reported that the "tops" of both vials have a "minty green top." The potassium phosphate from the new vial had approximately sixteen milliliters and the vial of normal saline had approximately 10.5 milliliters in it. Pharmacy Tech C stated, "There is overfill in most bottles of medications. I packaged all of that up. We wrote on it "this is a brand new one." I included the tops in the bags. We took the used ones that were sitting on top of the discard bin and put them in bags with the syringes. We documented everything that we could possibly document because I am not the one to try to cover up anything. They know better. The truth always comes out of the end."

Pharmacy Tech C stated that the day before the error, on 03/17/2023 she sent out an instant message to the general pharmacy chat. Pharmacy Tech C stated, "It's to everybody in the pharmacy that is involved. I was concerned about the coverage in the IV compounding area on Friday night, because it was a Friday night, and that was impacting patient care. I have a certain set of responsibilities when I first come in when I'm out of the pharmacy for sometimes an hour. Sometimes, I have to take our runner with me on part of it, so there's no tech left in the main pharmacy during that time. It is only the pharmacist."

Pharmacy Tech C stated, "I do not have faith in the Pharmacy Director. In fact, until she announced her resignation, I was looking for other employment. I no longer have faith in her as a leader, and I have told her as such. I'm really holding out hope. I believe we will have good changes to prevent things from happening in the future. I would also like to state with the potassium phosphate incident that as far as (name of Pharmacist D and name of Pharmacist J) go, when they both checked the medications, I really don't believe there was anything that they could have done differently, shy of physically watching her (Pharmacy Tech B) do it. That would have prevented it."

An interview was conducted on 04/06/2023 at approximately 3:30 PM, with the Chief Nursing Officer (CNO). The CNO stated Administration were notified on Saturday, 03/18/2023 that "The infant (infant #1) was not doing well. They had intervened multiple times through the night to stabilize the infant. The next morning my understanding was that we had a potential medication error given to the infant. The infant passed away." The CNO stated the hospital brought in the Division pharmacy lead to "Validate an extra external set of eyes to make sure that we felt comfortable with the process moving forward". "We communicated back to our nursing staff and our provider staff the steps that were put in place in the IV compounding area. I've been talking with the nursing staff just about the concerns. There is a high level of guard that is up regarding medications that were given. I know that there have been some things that were questioned. I know that we opened events for all of their concerns and reviewed those events to ensure that there wasn't anything that needed to be addressed".

The CNO stated, "We did hold some staff meetings to walk through the guardrails that we were putting in place. From a nursing standpoint, I haven't heard anything else. We're concerned about the event too because it's so emotionally charged for all of them. And so, everybody is guarded for sure."

A follow-up interview was conducted on 04/07/2023 at approximately 8:17 AM with Pharmacy Tech B who stated, "I have compounded potassium phosphate in the past for adults. We make those in bags for the adult population. I have never before this instance with the NICU baby, drawn up potassium phosphate for any pediatric or NICU babies. I have probably made errors in the past. But I cannot think of a specific instance off the top of my head."


Multivitamin Concern Infant #2

A review of the medical record for infant #2 revealed infant #2 was born on 03/22/2023, and had diagnosis' to include a single live born infant delivered by cesarean section, alteration in nutrition of newborn, need for observation and evaluation of newborn sepsis, prematurity birth weight 2.5 grams and over with 35-36 weeks of gestation, neonatal hypertension (high blood pressure), heart murmur, nasal CPAP (continuous positive airway) for respiratory support, hyperbilirubinemia (elevation of bilirubin) of prematurity, and transient tachypnea (respirations greater than 60 breaths a minute) of newborn.

Further review of the record for infant #2 revealed a physician's order for multivitamins with iron (MVI) 0.5 ML mix in a minimum of 5ML feed dated 03/29/2023. The following multivitamin with iron administrations were given to infant #2.

03/29/2023 at 10:57 AM
03/30/2023 at 10:52 AM and 11:00 PM
03/31/2023 at 10:52 AM and 11:05 PM
04/01/2023 at 11:00 AM and 11:54 PM
04/02/2023 at 11:02 AM and 10:53 PM
04/03/2023 at 11:00 AM and 10:56 PM
04/04/2023 at 11:24 AM and 10:58 PM
04/05/2023 at 10:48 AM and 11:01 PM
04/06/2023 at 11:17 PM

Further review of the record revealed a concern of a possible medication error with infant #2. In an email dated 04/02/2023 at 8:40 AM, sent by Pharmacy Tech P to the Director of Pharmacy and the Manager of Pharmacy, with a carbon copies (cc) to Pharmacist A, Pharmacist D, and Pharmacy Tech C. The email stated the following: "(name of nurse) brought over a syringe of Poly-Vi-Sol (Multivitamin) with Iron that the nurse suspected was not the correct drug (was brought to the pharmacy). We started our investigation and the syringe "name of nurse" brought was indeed not the correct drug. I pulled every Poly-Vi-Sol both with and without iron from each (name of the automated medication dispensing system) it was stocked in, as well at the bins in the pharmacy." "...after countless comparisons and smell tests, (Pharmacist A) and I are very confident that it was actually ferrous sulfate. While looking through the syringes, many of the syringes were not pulled back to the correct amount. There are multiple syringes within the same batch that are visibly different colors and smell totally different. If you smelled the Poly with iron, you know it is hard to mistake it for something else. We are sure that the drug given was not correct (emphasis added). We are also unsure of how many babies got the wrong drug from this batch as well. We got a new brand of ferrous sulfate, and our best guess is the tech who drew them up had both bottles on the UD (unit dose) counter waiting for them and didn't realize it was two different drugs. I tried to find the daily detailed sheet for the batch in question, but I couldn't find the sheet."

"As our night unraveled more issues arose involving cartfill (the filling of the hospital's automated medication dispensing system). The NICU (neonatal Intensive Care Unit) nurses were not comfortable giving the meds (medications) from cartfill. I totally understand we have not inspired confidence in them, and I was fully willing to do anything to make them feel comfortable giving meds. I pulled all cartfill meds from the delivered meds bin (except IV products) and completely replaced them, because I could not 100% guarantee that those meds were correct. They were comfortable giving the replacement meds. We made new batches of both Poly-Vi-Sol and Poly-Vi-Sol with iron, and I have segregated all of the old ones into bins and placed them into the Pharmacy Manager's office. We kept everything we thought might be important."

On Sunday, April 2, 2023, at 1:53 PM a reply from the Director of Pharmacy stated, "In reference to this - I had (Pharmacist D) open a new bottle of Poly-Vi-Sol with iron and compare it to the old dark version in the syringes and the light version in the syringes. The new bottle was very light in color and then I had them taste (emphasis added) the syringes and the new light and they tasted the same. I then had them compared to the plain or the plain iron - and it was similar in color (light) but tasted completely different. Therefore, the dark syringe and the light syringe were in fact the same product."

Further review of the email exchange revealed a reply from Pharmacy Tech C dated 04/03/2023 at 6:23 AM, in which she states, "I have come in this morning to assist with unit dose. Within twenty minutes of being here I've identified that the lot number on the multivitamins with iron that was in question is the lot number from the bottle of ferrous sulfate. This, accompanied with their very different smell and the fact that there is no record of this lot ever being checked, I am certain this is the wrong drug in the syringe. We've only been able to locate 20 of the syringes for this lot. Meaning there are approximately 80 doses that were likely given to babies."

Further review of the email thread from Pharmacy Tech C dated 04/03/2023 at 7:07 AM (44 minutes later) revealed, "Correction: The packaging summary says 200 were made. Leaving 180 missing."

An interview was conducted on 04/06/2023 at approximately 8:50 AM, with Pharmacy Tech C who stated the multivitamin with iron versus the iron sulfate medication error happened on Saturday, 04/01/2023 on the night shift. Pharmacy Tech C stated she came to work Monday, 04/03/2023 to assist in the unit dose compounding area of the pharmacy. She went on to state, "We were short staffed on that day and every day. Within twenty minutes of being there I was able to identify the bottle and the lot number of the medication error involving the iron. It was the Iron (AXK2101 expiration of 09/30/2023)". Pharmacy Tech C stated there were twenty syringes plus an additional syringe given back to the pharmacy staff. Pharmacy Tech C stated that one dose of multivitamin with iron versus iron was given to a patient in the NICU.

Pharmacy Tech C stated, "The nurse stated the medication smelled sweet and that alerted her that there was a problem. They investigated it on Sunday. The Pharmacy Director and Pharmacist D were not able to identify the lot number in question after tasting them. We were assured on Sunday they were the same product and they told us that the medications were multivitamins." Pharmacy Tech C stated she located the ferrous sulfate (iron) vial with the lot number. Pharmacy Tech C stated she was able to locate the package record and the multivitamin with iron versus iron sulfate were packaged on 03/03/2023. Pharmacy Tech C stated, "The original paper was in a filing cabinet. There was never a formal check by the pharmacist. It was not signed."

An interview was conducted on 04/05/2023 at approximately 7:15 PM, with Pharmacist A who stated he was on duty on the night shift when the iron sulfate and multivitamin error was brought to his attention. Pharmacist A stated the house supervisor came into the pharmacy and had a concern that one of the syringes in NICU "did not have the correct multivitamin in it." Pharmacist A stated, "We just started getting a new version of iron in the pharmacy. There is a distinct smell to the iron. It is a sweet smell". Pharmacist A stated that Pharmacy Tech P was also working with him on the night shift that night. Pharmacist A stated that after the report of a possible error, Pharmacist A and Pharmacy Tech P removed all of the possible incorrect syringes from the (name of the automated medication dispensing system).

Pharmacist A stated, "We had to draw up the correct multivitamins for the (name of the automated medication dispensing system) that night and replace them. I reported the error to the Director of Pharmacy and the Pharmacy Manager. The next morning, Pharmacist D stated they had checked the syringes by tasting them and that they were Iron and not multivitamins." Pharmacist A stated he received an email from the Director of Pharmacy stating that the syringes were checked and that they were "okay," and the syringes were multivitamins". Pharmacist A stated that Pharmacy Tech C reported to work the next morning and checked the lot numbers on the syringes of multivitamins. Pharmacist A stated, "The lot numbers on them were the lot numbers from the iron not the multivitamins." Pharmacist A stated that he was the only pharmacist at night in the main pharmacy. Pharmacist A stated, "It is almost a norm for me to be by myself. I know they have another position approved. Hopefully, that will make a difference".

An interview was conducted on 04/04/2023 at approximately 10:20 AM with Pharmacist D who stated the error with the multivitamin with iron versus iron sulfate was reported by a nurse from the NICU on the night shift on 04/01/2023. Pharmacist D stated a pharmacy technician reported to her the medication error on 04/02/2023, and that she gave a directive for all the syringes to be pulled from (name of the automated medication dispensing systems). Pharmacist D stated, "I kind of went into like disaster response mode. You know because at this point it's unfortunate. But if I didn't see it (the medication being drawn up) with my own eyes it's going to get pulled. Everything was pulled and the pharmacy technician then "redrew" a new batch of multivitamins."


Morphine Concern Infant #3

A review of the hospital event reporting system revealed a report dated 03/17/2023 regarding a Morphine dosing error. The report revealed "a near miss" (a near miss is a mistake that is caught before it occurs) reported by NICU staff. The report stated that a NICU Morphine 0.5 ml/0.2 mg (milligram) dose was pulled from the (name of the automated medication dispensing system) to be administered to infant #3. The registered nurse noticed the syringe only had 0.2 ml of Morphine in the syringe."

A review of the medical record for infant #3 revealed infant #3 was born on 02/22/2023. Infant #3 had diagnoses to include intrauterine drug exposure, newborn infant of 39 completed weeks of gestation, neonatal withdrawal syndrome, single liveborn infant delivered vaginally, and alteration in nutrition of newborn.

Further record review of infant #3 revealed a decreasing titrated order for Morphine written on 2/23/2023 and scheduled as follows:

03/29/2023 - Morphine Sulfate 0.05 mg by mouth every three hours.
03/28/2023 - Morphine Sulfate 0.7 mg by mouth every three hours.
03/27/2023 - Morphine Sulfate 0.9 mg by mouth every three hours.
03/26/2023 - Morphine Sulfate 0.11 mg by mouth every three hours.
03/25/2023 - Morphine Sulfate 0.13 mg by mouth every three hours.
03/24/2023 - Morphine Sulfate 0.15 mg by mouth every three hours.
03/22/2023 - Morphine Sulfate 0.17 mg by mouth every three hours.
03/19/2023 - Morphine Sulfate 0.19 mg by mouth every three hours.
03/18/2023 - Morphine Sulfate 0.21 mg by mouth every three hours.
03/17/2023 - Morphine Sulfate 0.23 mg by mouth every three hours.
03/16/2023 - Morphine Sulfate 0.25 mg by mouth every three hours.
03/15/2023 - Morphine Sulfate 0.27 mg by mouth every three hours.
03/14/2023 - Morphine Sulfate 0.27 mg by mouth every three hours.
03/13/2023 - Morphine Sulfate 0.29 mg by mouth every three hours.
03/12/2023 - Morphine Sulfate 0.31 mg by mouth every three hours.
03/08/2023 - Morphine Sulfate 0.33 mg by mouth every three hours.
03/07/2023 - Morphine Sulfate 0.22 mg by mouth every three hours.
03/05/2023 - Morphine Sulfate 0.27 mg by mouth every three hours.
03/04/2023 - Morphine Sulfate 0.15 mg by mouth every three hours.
03/02/2023 - Morphine Sulfate 0.1 mg by mouth every three hours.
03/01/2023 - Morphine Sulfate 0.09 mg by mouth every three hours.
02/28/2023 - Morphine Sulfate 0.1 mg by mouth every three hours.
02/26/2023 - Morphine Sulfate 0.12 mg by mouth every three hours.
02/25/2023 - Morphine Sulfate 0.14 mg by mouth every three hours.
02/23/2023 - Morphine Sulfate 0.16 mg (0.0611 mg/kg) by mouth every three hours.
02/23/2023 - Morphine Sulfate 0.28 mg (0.0996 mg/kg) by mouth every three hours.

An interview was conducted on 04/04/2023 at approximately 10:20 AM with Pharmacist D who stated a cartfill is done by our pharmacy techs. This process refills medications to be delivered to the floors (i.e. NICU). Pharmacist D stated the cart fill is done at the pharmacy window while staff members are "also triaging telephone calls and answering anything that comes to the window." Pharmacist D stated the hospital crash carts are refilled in the area as well.

Pharmacist D reported dispensing high levels of NICU morphine and multivitamins with iron and offered that the pharmacy dispensed approximately 1,100 - 1,200 syringes (unit doses) to the NICU, in the last three months. Pharmacist D stated, "We have had dosing errors with our morphine syringes. Actually, the day that the incident (with Infant #1) happened with the potassium phosphate, just earlier I had addressed three different incorrect doses of morphine. I also found a fentanyl medication that was expired. There have definitely been errors with this".
Pharmacist D stated the pharmacy technicians and pharmacists in the main pharmacy are "pulled in so many different directions.", and that the pharmacy technicians are doing multiple duties when working.

Pharmacist D went on to state, "The number of pharmacy staff at this hospital just seems like it's skin and bones. My fellow pharmacists, who work up on the floors even say they do not feel they should be covering that many floors on the adult side. The pharmacists on the floor feel like they are not able to be good pharmacists. I think the same goes for our technicians. It's unfortunate".

Pharmacist D stated another medication error that had happened in the NICU was related Morphine dosing on 03/17/2023, offering, "Recently there was morphine that was supposed to have 0.5 milliliters (mls), only had 0.2 mls." Pharmacist D stated "a lot of the errors have been with the NICU morphine." And that there "have been approximately 1,078 doses of NICU Morphine drawn up and scanned", from 01/01/2023 until 04/03/2023, and clarified that, "That's a controlled substance. It's a process to pull it out, reconstitute it, draw it up, and then check it". She went on to say that approximately 300 morphine syringes were pulled related to incorrect "math performed by a pharmacy technician". She reported the night shift has had the majority of the NICU morphine errors and the unit dosing areas of the pharmacy.

Additional interviews regarding low pharmacy staffing:

On 04/04/2023 at approximately 3:45 PM, an interview was conducted with Staff Member J, a registered pharmacist. Pharmacist J works 10 hour shifts and works 7 days on and then has 7 days off. She stated on the weekends she works in the main pharmacy from 5:00 PM - 9:00 PM. "I am the only pharmacist in the main pharmacy from 5:00 PM to 8:00 PM."

On 04/05/2023 at approximately 10:19 AM, an interview was conducted with Pharmacist L who stated she rotates and works in the main pharmacy at least 1 week a month. Pharmacist L stated she would have someone else working with her until 5:30 PM and then be by herself in the main pharmacy (only pharmacist) until 8:30 PM. She confirmed that IV medication compounding can take place during that time performed by the pharmacy technician. Pharmacist L described some of her duties to include answering phone calls, verifying orders that COE (centralized order entry) pharmacist couldn't do, call physicians for problems, cover (computer software) alerts related to drug interactions and laboratory results. She stated that she also signs anything that has to go out to the floor, to the automated medications system, and anything out of the IV room. Pharmacist L confirmed, prior to the 3/18 event, she was not present in the IV room when medications were compounded. When asked how she could verify the dose and medication if she was not present, she stated, "To be 100% honest, I have questioned that since day one. We had an IV room pharmacist all the time, there was never a time when there wasn't a pharmacist (IV pharmacist) [referencing previous experience]." Pharmacist L stated she questioned it here and was told "that is how things are, have been

46833

Based on staff interviews, clinical record review, review of death report, review of the Quality Improvement Program (QIP) corrective action plan, review of the hospital policies and procedure and review of Florida Pharmacy Law (rule Chapter 64B16-27.1001, Practice of Pharmacy, Florida Administrative Code), the hospital failed to follow hospital policy and Florida State Law regarding the preparation, dispensing and compounding of medications (a process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient). Both hospital policy and Florida State Law require a pharmacist to be physically present and give direction to the pharmacy technician when they are delegated the tasks of medication reconstitution, for the addition of additives, or for bulk compounding of the parenteral solutions (medications not given orally, typically provided directly into a vein, into a muscle or under the skin by injection). The lack of direct pharmacist oversight during medication compounding and dispensing resulted in medication errors affecting 3 of 3 sampled infants (#1, #2, and #3) who were patients in the Neonatal Intensive Care Unit (NICU) and resulted in the death of Infant #1 who received about 20 times the ordered dose of potassium phosphate. Infant #2 was ordered to receive Multivitamin with iron but instead received Ferrous Sulfate (Iron) up to 16 times before the error was caught, and Infant #3 was ordered to receive Morphine Sulfate at a titrated dose which was not drawn up correctly by the pharmacy. The hospital investigated and updated processes for NICU and pediatric medication compounding, but failed to address process changes for adult medication compounding. Interviews with 13 staff members (Chief Medical Officer, Vice President of Regulatory Compliance and Accreditation, Risk Manager, the Director of Pharmacy, the Pharmacy Manager, Pharmacists A, D, J, L, and Pharmacy Technicians C, I, P and Q) identified pharmaceutical quality concerns related to low staffing, policy interpretations, ongoing medication errors and that Pharmacy technicians continued to compound and prepare high risk medications without the pharmacist being physically present.

The pharmaceutical compounding and oversight failures have the potential to directly threaten patient safety for all 228 patients in the acute care hospital as well as its two standalone Emergency Departments (ED) who receive pharmaceutical services. Cross Reference A493, A489 and A283.

The findings include:

Hospital Policies on Medication Compounding and Florida State Law:

A review of the hospital policy and procedure entitled "Scope of Services - Pharmacy," PolicyStat ID 11991513, effective 08/18/2016 and last approved on 07/27/2022 includes the flowing information. Beginning on page 3, "Scope of the Pharmacist," 1. A pharmacist or registered pharmacy intern must: Interpret and identify prescription contents. 2. When parenteral and bulk solutions of all sizes are prepared regardless of the route of administration, the pharmacist must: Interpret and identify all incoming orders - Mix all extemporaneous (not prepared) compounding or be physically present and give direction to the registered pharmacy technician for reconstitution, for addition of additives, or for bulk compounding of the parenteral solution. Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation. Systematize all records and documentation of processing in such a manner that professional responsibility can be easily traced to a pharmacist. 3. Only a pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy. On page 5, Delegation and Supervision of Technicians - "1. Delegation: A pharmacist shall not delegate more tasks than he or she can personally supervise and ensure compliance with this rule." "2. Supervision: Delegated tasks must be performed under the direct supervision of a pharmacist and pursuant to the following definitions and requirements: Direct Supervision: means supervision by a pharmacist who is on the premises at all times the delegated tasks are being performed; who is aware of delegated tasks being performed; and who is readily available to provide personal assistance, direction and approval throughout the time the delegated tasks are being performed."

On page 6, 2. Delegable Tasks - The following tasks are delegable: Labeling of preparations and prescriptions; The counting, weighing, measuring and pouring of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication [dispensing] system; "Assisting in preparing parenteral and bulk solutions or assisting in any act involving sterile compounding must comply with the requirement of Rule 64B16-27.1001, F.A.C. (Florida Administrative Code)"

A review of Florida rule Chapter 64B16-27.1001, Practice of Pharmacy, of the Florida Administrative Code, effective 01/01/2010, revealed "Those functions within the definition of the practice of the profession of pharmacy, as defined by Section 465.003(13), F.S. (Florida Statutes), are specifically reserved to a pharmacist or a duly registered pharmacy intern in this state acting under the direct and immediate personal supervision of a pharmacist. The following subjects come solely within the purview of the pharmacist.
(2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the pharmacist must:
(a) Interpret and identify all incoming orders.
(b) Mix all extemporaneous compounding or be physically present and give direction to the registered pharmacy technician for reconstitution, for addition of additives, or for bulk compounding of the parenteral solution.
(c) Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation.
(d) Systemize all records and documentation of processing in such a manner that professional responsibility can be easily traced to a pharmacist.
(3) Only a pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy."

Summary of Potassium phosphate Compounding error - Infant #1:

A review of the medical record, timeline report and death summary for infant #1 revealed the infant was a one month and 14-day old female infant with a complicated history born at 27-weeks' gestation via Caesarean section due to maternal preeclampsia (a pregnancy complication marked by high blood pressure and presence of proteins in urine). Infant #1 had diagnoses to include: need for observation and evaluation of newborn for sepsis (infection of the blood stream), hypoglycemia (low blood sugar), apnea (cessation of breathing) of prematurity, heart murmur, late onset of neonatal sepsis, anemia (deficiency of healthy red blood cells) of prematurity, respiratory distress syndrome, alteration in nutrition of newborn, hyperbilirubinemia (high level of bilirubin in the blood), bowel perforation, hypotension (low blood pressure) in newborn, thrombocytopenia (too few platelets), infection due to Enterobacter Aerogenes, and hyperkalemia (high level of potassium). Blood chemistry results (labs) dated 03/18/2023 at 2:15 PM revealed a low potassium level of 3.1 MMOL/L (millimoles per liter) (Normal range 4 - 6.5 MMOL/L) and a low phosphorus level of 2.9 mg/dL (milligrams per deciliter) (Normal range 4.3-9.3 mg/dL). A physician ordered Potassium Phosphate 3MM/ML (millimoles per milliliter) 0.405 MM with 3.865 ml (milliliters) sodium chloride to infuse 4 ml (milliliters) at 2 ml per hour. Two pharmacists (Pharmacists D and J) performed the dosing calculations based on infant #1's weight and verified the dosing of potassium phosphate. The pharmacists' calculations revealed that infant #1 would receive 0.135 mls of a 3.3 millimole concentration of potassium phosphate (K+Phos) to be diluted with normal saline to infuse a total of four milliliters over two hours to infant #1. On 03/18/2023 at approximately 7:35 PM, resuscitation efforts began for infant #1 including chest compressions. Infant #1 had worsening hypoxia (low blood oxygen levels) and required mechanical ventilation. A repeat electrolyte laboratory test was completed on 3/18/2023 at 7:58 PM, which revealed infant #1's potassium level was critically high, greater than 10 MMOL/L and a serum phosphate level was greater than 18 mg/dL. A review of the NICU Death Summary revealed infant #1 expired on 03/19/2023 at approximately 3:02 PM. Infant #1 had received approximately 20 times the amount ordered of K+Phos.

Oral Multivitamin Concern Infant #2:

A review of the medical record for infant #2 revealed physician's order for multivitamins with iron (MVI) 0.5 ML mix in a minimum of 5ML feed dated 03/29/2023. Infant #2 received 16 doses of this medication without apparent adverse consequences. To explain the error, the hospital provided a copy of an email dated 04/02/2023 at 8:40 AM, sent by Pharmacy Technician P (Pharmacy Tech P) to the Director of Pharmacy and the Manger of Pharmacy, with a carbon copies (cc) to Pharmacist A, Pharmacist D, and Pharmacy Tech C. The email documented that a nurse suspected the medication in the syringe was not the correct drug. On site pharmacy staff immediately began investigating. The Pharmacy Tech P wrote, " ...after countless comparisons and smell tests, (Pharmacist A) and I are very confident that (the medication in the syringe) was actually ferrous sulfate. While looking through the syringes, many of the syringes were not pulled back to the correct amount." This conclusion was confirmed by Pharmacy Tech C who replied to the email on 04/03/2023 at 6:23 AM stating, " ...I've identified that the lot number on the multivitamins with iron that was in question is the lot number from the bottle of ferrous sulfate. This, accompanied with their very different smell and the fact that there is no record of this lot ever being checked, I am certain this is the wrong drug in the syringe. We've only been able to locate 20 of the syringes for this lot." At 7:07 AM, Pharmacy Tech C added, " ...The packaging summary says 200 were made. Leaving 180 missing."

Summary of Morphine Concern Infant #3:

The hospital provided a report dated 03/17/2023 regarding a Morphine dosing error. The report revealed "a near miss" (a near miss is a mistake that is caught before it occurs) reported by NICU staff. The report stated that a NICU Morphine 0.5 ml/0.2 mg (milligram) dose was pulled from the (name of the automated medication dispensing system) to be administered to infant #3. The registered nurse noticed the syringe only had 0.2 ml of Morphine in the syringe."

Staff interviews regarding Compounding and "physically present"

On 04/04/2023 at approximately 12:00 PM, an interview was conducted with Pharmacist D who stated that there was a lack of a dedicated pharmacist in the IV (intravenous) room. As a result of the event on 03/18/2023 (K+Phos compounding error, infant #1), the hospital changed their IV compounding process for the Pediatric/Neonatal intensive care unit (NICU) population. Pharmacist D stated "(the process) we have now is the most effective way to prevent something like that from happening." The new process requires that a pharmacist be physically present, standing at the compounding hood, to observe the Pharmacy Tech while compounding the ordered medication(s). This new process will allow the pharmacist to directly visualize and physically examine the contents, the vial(s) and the amount of medication in each syringe or bag. Pharmacist D, stated "I do think having a pharmacist in the room would have prevented the mistake from occurring." Pharmacist D expressed surprise that the new process did not include critical medications compounded for adults and stated, "I would like to see that, honestly, for all critical meds [medications], adults too." Pharmacist D recalled the events from 03/18/2023, stating she was the "only pharmacist in the main pharmacy." There was a Pharmacy Tech already in the IV compounding room when the medication order was received. Pharmacist D stated it was busy. I was answering phones, had a patient getting ready to discharge that needed a medication review, and was calculating and recalculating the amount of medication (an electrolyte) and diluent needed for infant #1. This was done repeatedly based on the infant's dry weight. Pharmacist D stated she even had the Pharmacy Tech calculate the amount and she got the same calculation, showing her, by holding up the calculator, so she could see the result displayed on the calculator screen through the window. The compounded medication was withdrawn into a syringe by the Pharmacy Tech. Pharmacist D stated she was not able to see the medication compounding process, as the Pharmacy Tech "had her back to me" because IV compounding takes place under the compounding hood (hoods are designed to reduce the risk of airborne contamination during the preparation of sterile products). Once the medication was compounded, Pharmacist D stated she was able to perform a verification, based on the labels, the syringe is labeled with the medication(s), amount and volume. Pharmacist D stated she also does a visual inspection of the vials.

Pharmacist D went on to state that the new process was specific to pediatric/neonatal intensive care unit (NICU) patients who are ordered medications that require IV compounding. She stated the process has not changed for the adult patient requiring IV compounded medications. Pharmacist D identified that pharmacy technicians compound high risk medications for the adult patients which includes medications such as heparin (an anticoagulant) and paralytics (powerful muscle relaxants used to prevent muscle movement during surgical procedures). The pharmacist stated since the event that occurred on 03/18, the pharmacy has not implemented the same changes for adult IV medication compounding. Pharmacist D was asked about the term "physically present" as found in hospital policy and Florida Law, and replied, "A pharmacist needs to be standing right there next to the tech (technician) when compounding."

An interview was conducted on 04/05/2023 at approximately 7:15 PM, with Pharmacist A who stated he was on duty on the night shift when the iron sulfate and multivitamin error was brought to his attention. Pharmacist A stated the house supervisor came into the pharmacy and had a concern that one of the syringes in NICU "did not have the correct multivitamin in it." Pharmacist A stated, "We just started getting a new version of iron in the pharmacy. There is a distinct smell to the iron. It is a sweet smell". Pharmacist A stated that Pharmacy Tech P was also working with him on the night shift that night. Pharmacist A stated that after the report of a possible error, Pharmacist A and Pharmacy Tech P removed all of the possible incorrect syringes from the (name of the automated medication dispensing system).

Pharmacist A stated, "We had to draw up the correct multivitamins for the (name of the automated medication dispensing system) that night and replace them. I reported the error to the Director of Pharmacy and the Pharmacy Manager. The next morning, Pharmacist D stated they had checked the syringes by tasting them and that they were Iron and not multivitamins." Pharmacist A stated he received an email from the Director of Pharmacy stating that the syringes were checked and that they were "okay," and the syringes were multivitamins". Pharmacist A stated that Pharmacy Tech C reported to work the next morning and checked the lot numbers on the syringes of multivitamins. Pharmacist A stated, "The lot numbers on them were the lot numbers from the iron not the multivitamins." Pharmacist A stated that he was the only pharmacist at night in the main pharmacy. Pharmacist A stated, "It is almost a norm for me to be by myself. I know they have another position approved. Hopefully, that will make a difference".

On 04/04/2023 at approximately 2:30 PM, an interview was conducted with Pharmacy Tech I who described the process for entering the IV compounding room and stated the new process in place is "that a pharmacist is present at the compounding hood when pediatric medications are compounded." She stated that the process for adult medication compounding has not changed and that a pharmacist does not need to be present. She confirmed that high risk medications for adults, including paralytics, are drawn up without the physical presence of a supervising pharmacist.

On 04/04/2023 at approximately 3:45 PM, an interview was conducted with Pharmacist J who stated before she came to work here, she was not much involved in the IV compounding process because there was an IV room pharmacist at her previous employment. "They would stay in the IV room all day long and it was easy for them to check things. They were physically able to watch pediatric compounding." Here, before this event, "we [a pharmacist] didn't go into that [IV] room." "We didn't watch the tech [technician] draw things up," "we only went into the IV room to check TPN (total parenteral nutrition)." "Now we are required to be in the IV room to observe the Pharmacy Technician when compounding IV medications for the Pediatric/NICU patient. Currently, we are not required to observe IV medication compounding for high risk/critical medications for the adult patient." Pharmacist J stated that the term "physically present" means to her, "in the IV room as they [pharmacy technician] drew it up".

On 04/05/2023 at approximately 10:19 AM, an interview was conducted with Pharmacist L who stated she was the only pharmacist in the main pharmacy from 5:30 PM until 8:30 PM. She confirmed that IV medication compounding can take place during that time performed by the Pharmacy Tech. Pharmacist L described some of her duties to include answering phone calls, verifying orders that COE (centralized order entry) pharmacist couldn't do, call physicians for problems, cover (computer software) alerts related to drug interactions and laboratory results. She stated that she also signs anything that has to go out to the floor, to the automated medications system, and anything out of the IV room. Pharmacist L confirmed, prior to the 3/18 event, she was not present in the IV room when medications were compounded. When asked how she could verify the dose and medication if she was not present, she stated, "To be 100% honest, I have questioned that since day one. We had an IV room pharmacist all the time, there was never a time when there wasn't a pharmacist (IV pharmacist) [referencing previous experience]." Pharmacist L stated she questioned it here and was told "that is how things are, have been and we don't have staff." Since the event, the process for medication compounding for the Pediatric/NICU population has changed and a pharmacist must be physically present watching the medication compounding process. If a pharmacist is not available a "live feed" camera has been installed in the compounding hood to allow the pharmacist to visualize and verify the medication compounding process. Pharmacist L stated she was told that this was "just for pediatric stuff," not the adult compounding process. She stated she has been "disappointed in the lack of response in management on how they handled this" and "there was no formal training or education provided, just our Daily Huddles (brief staff meetings conducted daily)". Pharmacist L stated that Risk Management came in with Division (executive staff) about a week ago to speak during "Daily Huddle" about the plan we were going to do going forward. A laminated sheet was sent out with the new process and discussed briefly at huddle. She stated there was "a group of 4 or 5 of us that pushed them into doing this [process]." "I didn't think it was going to change unless we pushed." Pharmacist L stated "we have been severely unstaffed. Management's response [is] to not jump in and help; in my previous experience, management has always helped. I voiced my concerns about this. I was met with 'it would be a patient safety concerns because I haven't practiced pharmacy in so long'. If you're my direct supervisor, you should be able to help." Pharmacist L stated they were down a graveyard (night shift) pharmacist and they had someone able to cover until the middle of April, but stated after that she was told instead of more help, "you can work extra or over-time." Pharmacist L complained of a lack of communication as well, stating there was an error that was identified this past weekend with a mix-up of syringes containing liquid multivitamin (MVI) and ferrous sulfate (iron supplement) that had not been addressed with staff. Pharmacist L stated that "Physically present" means going into the IV room and seeing the things that are going on and compounded."

On 04/05/2023 at approximately 11:00 AM, an interview was conducted with the Chief Medical Officer (CMO) who stated he is part of the organizational structure and oversees Quality, clarifying "anything that is a quality issue, I work hand-in-hand with Administration." The CMO was asked to review the policy "Scope of Services - Pharmacy," regarding his interpretation of "physically present". He stated it would be 2 people in the sterile compounding room, one providing direct supervision.

On 04/05/2023 at approximately 11:50 AM, an interview was conducted with the Pharmacy Manager who is also a member of the Medical Safety Committee and is under the supervision of the Director of Pharmacy. The Pharmacy Manager confirmed the IV medication compounding process has changed for pediatrics. The Pharmacy Manager stated, "Anytime pediatric anything, the pharmacist will go in and will talk out with the technician; kind of like a "timeout" for surgery - that's how I laid it out for the team." "Stop - look at the label, we have this drug, does it match the label, everything is timed out. Before you even touch a syringe or needle, we are verifying everything. We verify everything we have in front of us and are to make 1 product at a time." The Pharmacy Manager voiced concerns about "pulling up oral medication." Stating "Our area is small. The sheer amount of volume that we have to provide for the pediatric patient is substantial." "We don't have a good system in place for other oral medications. We need a bigger area. We need more staff." The Pharmacy Manager identified that "pediatrics is 90% of our labor in the pharmacy," and we have scanned over "4600 units in the last 3 months for pediatrics." "The sheer volume we compound is remarkable, would not be out of reason to have a dedicated pharmacy technician and pharmacist in there [IV room]." The Pharmacy Manager identified a "skeleton group" [the smallest number of people needed to keep a business or organization operating] working on the weekends and added that there is 1 pharmacist that comes in at 6 AM, 1 pharmacist at 7 AM, a NICU pharmacist that works 7:00AM to 5:00 PM that does rounds and assessments before coming back to the main pharmacy, and an ED (Emergency Department) pharmacist who comes on at 10:00AM and works until 9:00 PM, does rounds and then comes up to the main pharmacy, indicating around 4:00 PM. The ED pharmacist then works alone until the graveyard pharmacist comes in at 8:00 PM. The graveyard pharmacist works alone until the next morning. The Pharmacy Manager attributes more medication errors with low staffing. The Pharmacy Manager was asked for the interpretation of "physically present" as written in hospital policy "Scope of Services - Pharmacy." The Pharmacy Manager stated, "standing in the IV room."

On 04/06/2023 at approximately 8:55 AM, an interview was conducted with Pharmacy Tech C who stated she "honestly believes that this error (03/18) occurred because of being short staffed." "I am a graveyard technician and I work in the IV room; I work everything. Pt C stated, "The volume in the pharmacy has increased, we have 2 freestanding Emergency Departments, in January the rehab unit opened, and 4 North opened some time last year." She continued, "we have fewer techs, and the capacity has gone up by almost a third. I'm very hopeful with this change in management things will get better."

On 04/06/2023 at approximately 6:50 PM an interview was conducted with Pharmacy Tech P who stated her duties included maintaining the surgical department, the (named of the automated medication dispensing system) and all machinery to include fully maintaining the stocking and outdates. They are expected to do the adult cartfill, receive warehouse orders for the next shift to deliver, and also do basic duties such as answering the phone, triaging calls, talking to nurses and, "now with only 1 technician they are making all the IVs on the set, regardless with what else needs to be done. The amount is literally endless". Pharmacy Tech P confirmed there were changes made after the potassium phosphate incident on 3/18 but couldn't state them exactly. She stated she knows an email was sent out, and it was intended for a pharmacist to oversee the preparation of medication and there should be a second pharmacist to verify. At night it is different because they only have one pharmacist and one technician. Pharmacy Tech P went on to state that they installed a camera system over the compounding hood, so the pharmacist can watch through the camera system. She confirmed this was being done on the Graveyard shift. She stated she has never compounded potassium phosphate and feels it is inappropriate that a Pharmacy Tech is ever drawing that up. She stated that electrolytes in general are not used often, so not really a standard set, but that is when you need additional safety checks. Pharmacy Tech P stated she was the technician that was involved in discovering the MVI and ferrous sulfate syringes over the weekend. She said around 11:00 PM, the house supervisor brought over a syringe from NICU. The syringe in question was a dose that did not look and smell right to the nurse. She stated iron has a particular smell and it didn't smell like iron. She looked at the syringe and pulled out what it was supposed to be from stock and the color and smell were off. She stated this syringe had to be MVI. She immediately pulled all the syringes from all the (name of the automated medication dispensing system) machines and what was remaining in the pharmacy bins. Some of the syringes contained straight ferrous sulfate and other contained MVI. With the pharmacist on duty watching, we redid all the syringes. She states they were not able to initially find the "pick sheet" for this medication, but it has since been located and was compounded on Friday 03/03/2023. The error was discovered on 04/01/2023. "Since then, I've created an oral compounding log and checklist."

On 04/07/2023 at approximately 2:50 PM, an interview was conducted with Pharmacy Tech Q who stated " ...it's very busy in the pharmacy, its non-stop." Pharmacy Tech Q stated the pharmacy department has been short of staff for 6 months to a year. The department is aware of the issue and is looking for staff." Pharmacy Tech Q stated she feels the short staffing has contributed to medication errors. "There needs to be a dedicated unit dose person". She stated it has been brought to her attention about the oral medication compounding error with the MVI/ferrous sulfate. She stated she is not sure what happened, and offered that she did not compound ferrous sulfate, saying "sometimes people will come over to help" but that she cannot remember if this occurred that night. She offered that she was not really sure how the error occurred.

On 04/04/2023 at approximately 11:25 AM, the Director of Pharmacy (DoP) was interviewed about the potassium phosphate medication compounding error that occurred on 3/18/23 and resulted in the subsequent demise of infant #1. The DoP confirmed they have changed their process for all NICU (Neonatal Intensive Care Unit) medications, to include pediatric IV (intravenous - provided directly into the patient's veins) products. It is now required for the pharmacist to go in and double check the medications. The DoP stated that they must spell out how to check a product to ensure it is being done the same way. The Pharmacy Technician (Pharmacy Tech) cannot start doing anything until the pharmacist is standing at the Hood (compounding "hoods" are designed to reduce the risk of airborne contamination during the preparation of sterile products). When they draw up a diluent in a syringe, the pharmacy technician puts the syringe down on the hood, so the pharmacist has the ability to physically check the syringe. They do the same process for the additives; the pharmacy technicians must allow the pharmacist to visually inspect the medications. At that point, all the components used in the hood are tossed away. The product and label are signed off in the IV room and the final products are passed through the window to be sent up (to the patient unit). She stated she has spoken with each pharmacist and all staff have read and signed they understand and will comply with the changes. The DoP stated that all NICU medications are considered high risk. They had cameras in the IV room, but they were nonoperational. They are now operational, and the hospital has installed a camera in the hood so that a "live feed" of the compounding process can be observed; mainly for the benefit of the graveyard (night shift) pharmacist, since there is just one of them. She stated that the process for compounding of medications, to include high risk/critical medications for adults has not changed. She stated many of adult medications are compounded at the bedside, using a vial they snap together because they have vials in the (name of automated medication dispensing system) and bags in the storeroom. The DoP stated that the majority (about 95%) of compounding in the IV room is pediatrics/neonatal and confirmed that pharmacy technicians continue to compound high risk/critical medication for adults in the IV compounding room without the physical presence of a pharmacist.

The next day on 04/05/2023 at approximately 3:40 PM, a follow-up interview was conducted with the Director of Pharmacy (DoP). The surveyor asked the DoP about the meaning of the term "physically present" referenced in the hospital policy "Scope of Services - Pharmacy." Despite the process changes described by the DoP for NICU and Pediatric compounding the previous day, the DoP stated when the policy was created "physically present" was referring to "Direct Supervision." The DoP reviewed the policy and pointed and referenced the definition of "Direct Supervision," noted on page 5 of the policy entitled "Scope of Services - Policy," PolicyStat ID 11991513, which stated "Direct Supervision: means supervision by a pharmacist who is on the premises at all times the delegated tasks are being performed; who is ware of delegated tasks being performed; and who is readily available to provide persona assistance, direction and approval throughout the time the delegated tasks are being performed." The DoP stated that she does not dispute what is written, just the meaning. The surveyor informed the DoP that pharmacy staff members and the CMO all interpreted "physically present" as being right there, standing there (which is consistent with state law).

The DoP confirmed an error in the preparation of oral MVI (multivitamin) and ferrous sulfate (iron supplement) was discovered over the weekend. She stated, "there was a technician drawing up MVI and they grabbed a bottle of plain iron; they look very similar, they are the same color. So, when the compounding error took place, I'm not sure - it could have been compounded on a Friday. They (the pharmacy technician) had drawn from the iron bottle but labeled it as MVI. I couldn't tell you if the pharmacist checked it. The DoP says it was 200 syringes drawn up - some with MVI and some with Ferrous Sulfate, but all were labeled with MVI. She states that after the medications have been compounded a "pick sheet" is put on top of the tote for the pharmacist to check. I don't think a pharmacist laid eyes on those [syringes] before the pharmacy technician ba