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Based on document review and staff interviews the hospital's administrative staff failed to ensure all medications were prepared and administered according to the orders of a physician responsible for the patients care and accepted standards of practice for 1 of 15 inpatient closed medical records reviewed (Patient #1). Failure to verify a doctor's order may result in a patient receiving medication not in alliance with the doctor's plan for medical treatment and may not be the appropriate medication type, dose, route, and time potentially resulting in a severe adverse reaction and/or death. The hospital's administrative staff identified 369 patients at the time of the survey.

Findings include:

1. Review of the policy, "Administration of Medications," effective June 2022, revealed in part, " ...Before administration of a medication, the individual administering the medication does the following: Verifies that the medication selected matches the medication order and product label... Verifies the medication is being administered at the proper time, in the prescribed dose, and by the correct route, using bar code technology whenever available." " ...If BCMA (barcode medication administration) is unavailable, a paper MAR or other paper-based documentation is utilized. Patient identification is validated and 5 rights of medication administration utilized.

2. Review of Patient #1's medical record revealed Patient #1, a 3-year-old child, presented to the hospital's Emergency Department (ED) on 10/3/22 at approximately 11:58 AM, after having tonsils and adenoids removed and tubes placed in both ears on 9/30/22. Patient #1's parents were unable to get Patient #1 to eat or drink after the 9/30/22 surgery, so the parents brought Patient #1 to the ED under the direction of the surgeon for evaluation. The ACH's computerized order entry system was inoperable at the time of Patient #1's arrival to the ED. Patient #1 was placed on an intravenous (IV) of normal saline fluids in ED due to dehydration. After several hours of attempting to stabilize Patient #1 by providing pain medication, fluids, anti-nausea medication, and attempting to have Patient #1 accept oral food and fluids, ED Physician A consulted with Pediatric Physician B to admit Patient #1 for observation to the Pediatric inpatient unit. Patient #1 was admitted to inpatient Pediatric floor at approximately 8:10 PM. Upon admission to Pediatric floor Pediatric Physician B wrote a paper order for pain medication of Hydrocodone/Acetaminophen 7.5 milligram (mg)/325mg/15 milliliter (mL), 3mL every 4 hours as needed for moderate pain. Pediatric Physician B included on the order Patient #1's name, age, and weight prior to the Registered Nurse (RN) C sending a copy of the order to the pharmacy. On 10/3/22 at 11:00 PM Patient #1 received 3mL of Hydrocodone/Acetaminophen 7.5mg/325mg oral elixir from RN C from paper order that Pediatric Physician B wrote. Patient #1 then received the second dose of pain medication from a paper Medication Administration Record (MAR) sent from Pharmacy. The paper MAR was generated by Pharmacist F (after Pharmacist F incorrectly entered the order in Medication Manager System for Patient #1 reflected a dose of 15mL (5x the prescribed dose) instead of 3mL dose Hydrocodone/Tylenol 7.5mg/325mg. Patient #1 was administered 15ml dose on 10/4/22 at 8:25 AM by RN D.

3. Review of an Incident Report completed by RN D on 10/13/22 revealed, around 8:20 AM RN (D) administered 15mL of Lortab (7.5mg/325/mg Hydrocodone/Acetaminophen) per the paper MAR to the patient. 15 mL was the dose listed to give the patient. Patient spit out some of the medication. After giving the Lortab, RN (D) checked dosage and alerted the Resident (E) of the dose given from the paper MAR. The RN (D) and Resident (E) calculated the weight-based dose which was 3mL. RN (D) alerted Mother of the large dose and placed a continuous pulse ox on the patient. Resident (E) also talked to Mother. Continuous pulse oximetry (are typically used for long period (1 hour or more) oxygen (SpO2) and heart rate measuring) was kept on for 6 hours after the dose was administered. Patient was monitored but did not need any additional intervention. Vitals were in normal range for the duration of the event. Reviewer's Comments at the end of the Incident Report showed the medication error occurred during downtime; pharmacy, incorrectly entered dose from paper order as 15mL instead of 3mLs. RN did not question dose on the printed MAR before giving med to patient. Physician resumed medication later that afternoon. Patient received 3mL dose at 6:41 PM and was discharged home at approximately 9:50 PM on 10/4/22.

4. During an interview on 11/1/22 at 1:00 PM with Pharmacist F, who entered the orders for Patient #1, revealed Pharmacist F normally handles pharmaceutical needs for the adult critical care/adult medical-surgical units. Approximately at 8:00 PM, Pharmacist F went to the Main Pharmacy to help during the downtime. When Pharmacist F arrived only 3 people were helping and paper orders were arriving in large quantities. The pharmacist working at that time was falling behind on orders entry, phone calls and duplicate orders were increasing because of the backlog in entering orders. Pharmacist F acknowledged they did not verify the dosage for the hydrocodone/acetaminophen order against the physician's written order for Patient #1.

5. During an interview on 10/31/22 at 2:30 PM with RN D, who administered the excessive dose of hydrocodone/acetaminophen to Patient #1, revealed RN D administered the dose that was printed on the paper MAR, which was 15mL verses a 3mL dose, sent from the ACH's Pharmacy. When RN D administered the medication to Patient #1 they reported most of it was spit out. RN D acknowledged that they did not verify the medication and realized their mistake when they sat down to chart and had seen the previous dose given by RN C as 3mL then immediately sought-after Resident E, who verified the dose should have been 3mL instead of 15mL.

6. Review of the policy, "Incident Reports" effective 12/2021 revealed in part, " ...An incident is defined as an event that is inconsistent with the routine care of the patient, resident, including near misses, or an event that is inconsistent with normal operations that could have or did have an undesirable impact on a patient, resident, visitor, or employee."

7. During an interview on 11/2/22 at 12:58 PM with Director of Pediatrics and PICU revealed an incident report had not been filed because with the system down RN D could not enter it into the IRIS (The Incident Response Improvement System (IRIS) is a web-based incident reporting system for reporting and documenting responses) system. Once an incident report is entered into the IRIS system the Clinical Coordinator Risk Management is notified of the event.

Based on document review and staff interviews, the acute care hospital's (ACH) administrative staff failed to ensure the pharmacy services were adequately staffed during an emergency. The cumulative effect of this failure and deficient practice resulted in the hospital staff failing to ensure all patients receiving medical treatment were safe. The hospital's administrative staff identified a census of 369 patients at the time of the survey.

1. Ensure the pharmacy have an adequate number for personnel to ensure quality and safe services. Please refer to A-500.

2. Ensure pharmacy services staff followed the policy for medication administration during the computer downtime procedures. Please refer to A-500.

3. Ensure all pharmacy services staff completely verify all medication entries during the computer downtime procedures. Please refer to A-500.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to provide patient safety during medication administration to avoid medication errors.

4. The survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Pharmaceutical Services (42 CFR 482.25). The SA notified the administrative staff on 11/2/22. The hospital failed to provide adequate pharmacy staff during an emergency situation. The hospital's administrative staff removed the immediately prior to the survey team exiting on 11/9/22 when the administrative staff took the following actions:

a. The Pharmacy Department's Work from Home Policy, was revised.

b. All pharmacy personnel not involved in direct patient care must report to the main pharmacy for possible reassignment.

c. The 15mL product (Lortab) removed from standard Pyxis inventory on pediatric units.

d. Add an electronic warning for nurses when removing Lortab elixir in the Pyxis.

e. Add the usual pediatric does information to product notes in Cerner software.

f. Remove pediatric weight-based doses from 15mL unit dose cups in Cerner order catalog.

g. Educate pharmacy, nursing and providers regarding the removal of Lortab and additional pop up alerts in Cerner software.

h. Create a Provider Downtime (DT) Medication Order form.

i. Educate staff and providers to the new Provider Downtime (DT) Medication Order form, via emails, department huddles, a Process Change Alert, and 1:1 communication.

j. Review and revise the Incident Reporting policy.

k. Educate staff on the changes made to Incident reporting policy and paper incident reporting.

l. Review and revise the Inpatient Pharmacy Disaster policy.

m. Hold a mock drill focused on improving Downtime medication processes.

Based on document review, and staff interview the Acute Care Hospital's (ACH) administrative staff failed to implement safeguards in the Pyxis (automated medication machine) to prevent the wrong dose of medication being entered when the ACH's electronic medical record (EMR) was inoperable. Failure to implement safe guard alerts resulted in 1 out of 15 patients (Patient #1) receiving the wrong dose of a potentially dangerous pain medication which could have resulted in serious physical harm or death.

Findings include:

1. A disruption in the hospital's computer system occurred on 10/3/22 around 2:00AM. As a result, there was no interface (computer connection) between the Pyxis medication dispensing machine on the inpatient pediatric unit and the pharmacy's computer system. This required the hospital staff to send handwritten orders on paper to the pharmacy for entry into a back-up computer system called Medication Manager. This allowed the pharmacy to provide the floor nurse a paper medication administration record (MAR) (a medication administration record is a record, usually a computer-generated document), that communicated with the Pyxis machine. Medication Manager did not have the necessary electronic dispensing safeguards found in the pharmacy's main computer system.

2. Review of Patient #1's medical record showed that on 10/3/22 at 8:10 PM, Pediatric Physician B wrote an order on a paper order form for Lortab (pain medication) 3ml elixir to be given every 4 hours as needed for moderate pain. The physicians order form also specified Patient #1's age and weight so the appropriate dose would be given.

At 2030, RN C noted the order from Pediatric Physician B and RN C sent the order to the pharmacy.

3. During an interview on 11/1/22 at 1:00 PM with Pharmacist F acknowledged they incorrectly entered Pediatric Physician B's paper order for Lortab 3 ml elixir as Lortab 15 ml elixir into Medication Manager which generated Patient #1's printed medication administration record, which was then sent to the pediatric floor to be used by Patient #1's nurse. Pharmacist further stated they failed to check the patient's weight to verify the accuracy of the dose entered.

4. During an interview on 10/31/22 at 2:30 PM, RN D confirmed they administered Lortab 15 ml to Patient #1 on 10/4/22 at approximately 8:20 AM. RN D confirmed they did not realize they had administered the incorrect dose until they reviewed Patient #1's medical record and saw the previous dose by RN C was 3 ml.

5. Review of Incident Report completed by RN D on 10/13/22 (ten days after Patient #1 received the incorrect dose of Lortab) showed around 8:20 AM RN (D) administered 15ml of Lortab per the paper MAR to the patient. Patient spit out some of the medication. After giving the Lortab, RN (D) checked dosage and alerted the Resident (E) of the dose given from the paper MAR. The RN (D) and Resident (E) calculated the weight-based dose which was 3mL. RN (D) alerted Mother of the large dose and placed a continuous pulse ox on the patient. Resident (E) also talked to Mother. Continuous pulse oximetry (are typically used for long period (1 hour or more) oxygen (SpO2) and heart rate measuring) was kept on for 6 hours after the dose was administered. Patient was monitored but did not need any additional intervention. Vitals were in normal range for the duration of the event. Reviewer's Comments at the end of the Incident Report showed the medication error occurred during downtime; pharmacy, incorrectly entered dose from paper order as 15mL instead of 3mLs. RN did not question dose on the printed MAR before giving med to patient. Physician resumed medication later that afternoon. Patient received 3mL dose at 6:41 PM and was discharged home at approximately 9:50 PM on 10/4/22.

6. Pharmacist F failed to implement safeguards by double checking the order and verifying Patient #1's weight to confirm the accuracy of the dose of Lortab entered into Medication Manager to prevent Patient #1's medication error while the hospital was experiencing a failure in the computer system.