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NORTH CAROLINA BAPTIST HOSPITAL MEDICAL CENTER BOULEVARD WINSTON-SALEM, NC 27157 April 18, 2019
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical device manufacturer information pamphlet, medical record review, observation and staff interview the hospital staff failed to ensure medication administration was followed as per physician order for 1 of 1 patients (Patient #5) with the use of (Humulin R, U-500 Insulin KwikPen).

Findings included:

Review of hospital policy for "Medication Use Processes", revised date: 01/2019 revealed 1) General Policy Statement: "... 1. Medications are safely and accurately administered (mm.06.01.01) ...1) Verifies that the medication selected for administration is the correct one based on the medication order and product label. ...4) Verifies that the correct medication is being administered to the correct patient at the proper time, in the prescribed dose, and by the correct route ..."

Review of medical device manufacturer pamphlet for the medication "Humulin R, U-500 Insulin" revealed, the medication "... Is a man-made Insulin that is used to control high blood sugar in adults and children with diabetes mellitus who need more than 200 units of Insulin in a day. Humulin R, U-500 Insulin KwikPen contains 5 times as much Insulin (500 units/ml) in 1 ml as standard Insulin (100 units/ml). ...When using the Humulin R, U-500 Insulin KwikPen: The Humulin R, U-500 Insulin KwikPen is specially made to dial and deliver doses of Insulin. Do Not use any syringe to remove Insulin from your Humulin R, U-500 Insulin KwikPen. The markings on certain syringes will not measure your dose correctly. A severe overdose can happen, causing low blood sugar, which may put your life in danger. ..."

Active medical record review revealed Patient #5 presented to the ED (Emergency Department) where MD (Medical Doctor) #2 conducted the "Hospitalist History & Physical Note" (H&P) on 03/02/2019 at 0341 for a chief complaint of "Transfer for sepsis". Patient #5 was transferred from an outside acute care facility after treatment for recent Panniculitis, chronic pain and recent diagnosis and treatment for a Pulmonary Embolus. Record review of the H&P revealed MD #2 documented, "...Upon my evaluation, patient reports dysuria for the past 2 days, cough productive of white sputum tinged with blood, fevers,and bilateral abdominal wall pain. Denies any chest pain or shortness of breath. ..." Record review revealed Patient #5 was a [AGE] year old female admitted on [DATE] through current date with a diagnosis of [DIAGNOSES REDACTED]" Record review revealed an order entered as scheduled "Start date/time as 03/07/2019 at 1700 through end date/time as 03/09/2019 at 1954" was entered by MD #3 for the administration dose of 130 units of Humulin R, U-500 Insulin KwikPen injection. On 03/07/2019 at 1425 RN #2 acknowledged the order for Humulin R, U-500 Insulin KwikPen. Record review of the Internal "Investigative Summary" revealed Patient #5 received 650 units (5 times the intended dose of Humulin R, U-500 Insulin KwikPen) by way of RN #2 retrieved the medication by way of use of one 50 unit Insulin syringe and one 100 unit Insulin syringe. Review of the "Investigative Summary" revealed, RN #2 drew up 30 units into the 50 unit Insulin syringe and 100 units of Insulin into the 100 unit Insulin syringe. Medical Record review revealed Patient #5 received the incorrect dose of Humulin R, U-500 Insulin KwikPen at around 1430, however the error was identified around 1815.

Interview request with Patient #5 on 04/16/2019 at 1545 declined by Patient #5.

Observation request for Humulin R, U-500 Insulin KwikPen administration for Patient #5 on 04/17/2019 at 1430 declined by Patient #5.

Interview conducted with RN #2 on 04/17/2019 at 1307 revealed RN #2 was the nurse who provided care on 03/09/2019 day shift for Patient #5. Interview revealed, RN #2 had planned to administer Humulin R, U-500 Insulin KwikPen to Patient #5 at around 1430, however the Kwikpen device for measured administration malfunctioned at the time of set up for delivery of the medication. Interview revealed RN #2 retrieved the Insulin solution via the use of a 50 unit Insulin syringe and a 100 unit Insulin syringe. Interview revealed RN #2 drew up 30 units into the 50 unit Insulin syringe and 100 units into the 100 unit Insulin syringe. RN #2 obtained a second nurse verification from RN #3 who was explained that the Insulin was obtained from the Kwikpen via a syringe due to the malfunction of the Kwikpen device. Interview revealed, RN #2 administered the Humulin R, U-500 Insulin KwikPen to Patient #5 via the use of 2 separate Insulin syringes. Interview revealed RN #2 requested a replacement Kwikpen from pharmacy after the delivery by way of the 2 insulin syringes. Interview revealed RN #2 realized later during her shift that the Humulin R, U-500 Insulin KwikPen was in a higher concentration solution and that the Kwikpen was intended to be used with device specific needles via the priming of the needle and dial up device delivery of specific amounts of Humulin R, U-500 Insulin KwikPen only using the Kwikpen delivery mode. Interview revealed notification was made to RN #3, the Attending Physician, and the on-call Physician came to assess the Patient #5 at bedside.

Interview was conducted with RN #4 on 04/17/2019 at 1405 revealed during the week of 03/10/2019 nursing staff education was provided to assure that all RN staff were made clearly aware that there should never be the use of a syringe of any kind to obtain Insulin solution from a Kwikpen device. Staff education was specifically informed that the Kwikpen device has device specific needles for the use of the Kwikpen delivery system. Plans were initiated to provide further education house wide and the process has been presented to the Best Practice Advisory committee. All units have been discussing the education as a focus during huddle as an ongoing "Hot Topic" review daily. The informatics committee is working on building an alert based on the Glucose Management committee and the Best Practice Advisory committee suggestions.

Interview was conducted with MD #5 on 04/18/2019 at 1040 revealed, MD #5 was made aware of the medication administration error that occurred for Patient #5 about 1400 on 03/09/2019 by way of telephone call at around 1900. MD #5 consulted with the Endocrinology physician on-call to review the findings of the medication administration error and develop a plan of care for management of the patient for potential [DIAGNOSES REDACTED]. MD #5, RN #2, and RN #3 disclosed the medication administration error that occurred on 03/09/2019 roughly at 1800 to the Patient #5, explained the plan of care for management for the potential [DIAGNOSES REDACTED] with close monitoring of blood glucose levels every hour and the IV infusion of Dextrose 5% and .9 Normal Saline. Interview with MD #5 revealed there was no evidence of critical [DIAGNOSES REDACTED], the lowest glucose result was 87 during this close monitoring period. Interview with MD #5 revealed, "...Patient #5 was and still is extremely Insulin resistant. I liberalized her diet overnight. I feel everything was done to correct the medication error in the surrounding time frame to adjust for the result of the patient receiving higher dose of concentrated Insulin." Interview revealed, no injury occurred as a result of the incorrect dose of the concentrated Insulin administration on 03/09/2019 for Patient #5.

NC 078, NC 660