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Tag No.: A0398
Based on observation, interview and record review, the hospital failed to follow their policy and procedure (P&P) titled, "Point of Care Testing Nova StatStrip Glucose Meter (glucometer - used to test blood sugar level)," when glucose control solutions (GCS -used to ensure glucometer accuracy and reliability of test results) were not labeled with legible discard date and not discarded after 90 days (after opened). These failures had the potential to result in patients having inaccurate blood glucose test results.
Findings:
During a concurrent observation and interview on 7/7/25 at 10:09 a.m. with Registered Nurse (RN) 1, the glucose testing supply box contained one red topped bottle (level 3 - higher blood glucose level) with discard date of 6/16/25 and one green topped bottle (level 1 - lower blood glucose level) with a discard date that was unable to be read. RN 1 stated the red and green topped bottles contained solutions used daily to test the glucometer to ensure accurate patient blood sugar test results. RN 1 stated the red topped bottle should have been discarded on 6/16/25 (21 days prior). RN 1 stated she was unable to read the outdate on the green topped bottle.
During an interview on 7/7/25 at 10:10 a.m. with Emergency Department Manager (EDM), EDM stated the control solutions are good for 90 days after opened. EDM stated when opened the nurse was expected to write the "discard by" date on the front of the solution bottle. EDM stated the nurse who performs the glucometer testing each day was to check the discard dates before use of the control solutions. EDM stated if the solutions were used past the discard date, the glucometer control test results could give a false reading which could affect patient blood glucose testing by producing inaccurate results.
During a review of the hospital's P&P titled, "Point of Care Testing Nova Statstrip Glucose Meter," dated 10/14/24, the P&P indicated, "2. StatStrip Glucose Control Solutions: Level 1 and 3. . . c. Once opened, the controls are stable for 3 months or until manufacturer's expiration date, whichever comes first. D. Note expiration date once open."
Tag No.: A1104
Based on interview and record review the hospital failed to follow their policy and procedures (P&P) when:
1. One of one Emergency Department crash cart didn't have expired items discarded. This failure had the potential for outdated supplies to be used on patients.
2. Two of three sampled patients (Patient 13 and Patient 17) had an incomplete "Acute Ischemic Stroke (AIS - occurs when blood clots or narrowed arteries restrict blood flow to the brain) TNKase (tenecteplase- medication to treat AIS by breaking down blood clots) Infusion Order Sheet (AISTIOS)." This failure had the potential to affect the decision to administer TNKase.
3. One of three sampled patients (Patient 13) received more than the maximum dose per P&P of TNKase. This failure had the potential for bleeding in the brain.
Findings:
1. During a concurrent observation and interview on 7/7/25 at 9:40 a.m. with Emergency Department Manager (EDM) in the Emergency Department (ED), the crash cart was checked. On the fifth drawer there was a white sticker titled "Crash Cart Item Check." The sticker indicated on 7/1/25 the first item to expire was 18 gauge needles. On the sixth drawer there was a white sticker titled "Crash Cart Item Check." The sticker indicated on 7/6/25 the first item to expire was 10 fr (french -unit of measurement for the size of medical tubes) Triflow (suction tubing).
During an interview on 7/7/25 at 9:41 a.m. with Emergency Department Director (EDD), EDD stated, "They [staff] should check and call for replacement (of expired supplies)."
During a review of the facility's P&P titled, "Emergency Crash Cart Procedure," revision date 8/15/22, the P&P indicated, "B. Pharmacy Procedures: 5. The contents of the medication drawer(s) shall be inspected at least every 30 days by Pharmacy personnel to check for outdates and ensure lock integrity. D. Nursing Procedures: 6. b. A visual check to review earliest expiration stickers on all of the locked supply drawers. If any drawers are expiring before the next inspection, the Charge Nurse will be notified to coordinate exchange of the appropriate supply trays. 7. The crash cart checklist will be completed at least once every 24 hours."
2. During a concurrent interview and record review on 7/8/25 at 9:30 a.m. with Stroke Coordinator (SC), the Electronic Medical Record (EMR) for Patient 13 was reviewed. The following was noted:
ED Physician Notes, dated 4/29/25 at 08:04 (8:04 a.m.), indicated "Medical Decision Making: . . .we agreed to give the patient TNK (tenecteplase). . . TNK given at 0800."
AISTIOS, dated 4/29/25 for Patient 13 was not completed. SC confirmed the AISTIOS was incomplete.
During a concurrent interview and record review on 7/8/25 at 11:00 a.m. with SC, the EMR for Patient 17 was reviewed. The AISTIOS, dated 6/2/25 for Patient 17 was not completed. SC stated, "It [AISTIOS] should of been completed. There's only one box marked for if the patient is 18 years."
During an interview on 7/8/25 at 11:22 a.m. with SC, SC stated "The nurses are taught that the form needs to be done. There is a time out for the form before giving the medication [TNK]."
During a concurrent interview and record review on 7/8/25 at 1:36 p.m. with Registered Nurse (RN) 2, Patient 17's AISTIOS was reviewed. RN 2 stated she was the nurse to verify the TNK dose was correct. RN 2 stated, "The bedside nurse is to review it. If it's not done the nurse should let the doctor know to complete it. Check the boxes."
During a concurrent interview and record review on 7/9/25 at 9:58 a.m. with Registered Nurse Regulatory Specialist (RS), the AISTIOS for Patient 13 and Patient 17 was reviewed. RS stated RN 3 was the administering RN for Patient 13, and RN 4 was the administering RN for Patient 17.
During a concurrent interview and record review on 7/9/25 at 10:02 a.m. with EDM, the "ED Boot Camp (EDBC)," sign-in sheet, dated 8/20/24 - 8/23/24 was reviewed. The EDBC indicated RN 3 attended and received training.
During a review of the facility training document titled EDBC, dated 8/20/24 thru 8/23/24, the EDBC indicated, "TNK - Inclusion/Exclusion criteria is required."
During a concurrent interview and record review on 7/9/25 at 10:17 a.m. with RS, RN 4's "AHKC [facility name/county] Stroke Center Orientation (ASCO)" Certificate of Completion and training documents, dated 5/1/25 were reviewed. The ASCO training documents indicated, Slide 34 "Start the inclusion/exclusion criteria. . . .Pull the TNK to the bedside - Do NOT open until you have an order for the TNK and inclusion/exclusion criteria met!"
During a concurrent interview and record review on 7/9/25 at 10:45 a.m. with RN 4, the AISTIOS for Patient 17 was reviewed. RN 4 confirmed that out of the 28 check boxes for the Inclusion and Exclusion criteria there was only one box checked. RN 4 stated the form has to be completed prior to the TNK administration. RN 4 stated, "It's my responsibility to ensure it's completed, and it's not."
During an interview on 7/9/25 at 10:47 a.m. with RN 4, RN 4 was asked if she received training on completing the AISTIOS form, and RN 4 stated, "Yes, I did."
During a review of facility training document titled, "Stroke Quality Metrics (SQM)," dated 2025, the SQM indicated, "Before administering TNK, our stroke form must be filled out. . . Key points before TNK administration: Inclusion and exclusion criteria on the stroke form must be filled out by the ED physician . . .but the ED provider and nurse must still review the ENTIRE inclusion and exclusion checklist. Test Question- 4. True of False: It is the telestroke doctor's responsibility to assure the inclusion and exclusion criteria is done. False: . . . it is the bedside nurse's and ED physician's role to go over the complete inclusion and exclusion criteria list."
During a review of the facility's P&P titled, "Thrombolysis (a medical procedure that breaks down blood clots that are blocking blood flow in veins or arteries) For Acute Ischemic Stroke," revision date 12/2/22, the P&P indicated, "C. Procedure: 1. Provider and/or Neurologist to assess for inclusion and exclusion criteria for thrombolysis. 2. The inclusion and exclusion criteria form (Attachment A) will be signed, timed, and dated by the ordering provider, or otherwise entered into the medical record indicating the review of the information on this form will be completed prior to ordering thrombolytic (medications that dissolve blood clots)."
3. During a concurrent interview and record review on 7/7/25 at 2:50 p.m. with Quality Assurance Registered Nurse (QRN), Patient 13's EMR was reviewed. The following was noted:
ED MSE (Medical Screening Exam- a procedure to detect health issues in individuals who don't yet have symptoms, often before they would typically seek medical care), dated 4/29/25 indicated TNK if no bleed.
ED Physician Notes, dated 4/29/25 at 08:04 (8:04 a.m.), indicated "Medical Decision Making: . . .we agreed to give the patient TNK (tenecteplase). . . TNK given at 0800."
AISTIOS dated 4/29/25, indicated at the top of box for administration "Dose: 0.25 mg (milligram)/kg (kilograms) (MAX [maximum] DOSE: 25 mg)" The bottom of box for calculation of administration indicated "Total Dose: 30 mg 6.5 ml (milliliter) given at 0800 (8:00 a.m.)."
During a concurrent interview and record review on 7/8/25 at 8:35 a.m. with Risk and Regulatory Analyst (RRA), Patient 13's Physican Order for TNK was reviewed. RRA stated Patient 13 received 30 mg of TNK, and confirmed the order indicated a max dose of 25 mg.
During a concurrent interview and record review on 7/8/25 at 9:52 a.m. with SC, the EMR and AISTIOS for Patient 13 was reviewed. SC stated 25 mg was the recommended max dose. SC stated, "The dose was off of the patient weight. The Doctor talked to the wife about patient [Patient 13] getting 30 mg. There should be documentation about the overdose." SC was unable to find documentation of a note regarding overdose.
During an interview on 7/8/25 at 1:38 p.m. with RN 2, RN 2 stated 25 mg of TNK is the max dose, and the two nurses are to check the dose before giving. RN 2 was asked about giving a dose of 30 mg, and RN 2 stated, "You can't the max is 25 mg."
During an interview on 7/8/25 at 1:47 p.m. with EDD, EDD stated, "There should be some type of documentation for giving more than the max amount."
During a concurrent interview and record review on 7/8/25 at 1:58 p.m. with EDD and SC, Patient 13's Medication Administration Record and AISTIOS was reviewed. EDD and SC confirmed Patient 13 received 30 mg of TNK. EDD stated "It's not recommended." SC stated "There was no note by the Physician. It was a medication error."
During a concurrent interview and record review on 7/9/25 at 10:02 a.m. with EDM, the "ED Boot Camp (EDBC)" sign-in sheet, dated 8/20/24 - 8/23/24 was reviewed. The EDBC indicated RN 3 attended and received training.
During a review of the facility training document titled EDBC, dated 8/20/24 thru 8/23/24, the EDBC indicated, "Policies reviewed during this Boot Camp: Acute Ischemic Stroke Management. Nursing & Thrombolysis for Stroke. Policy No. 16017."
During a review of facility training document titled, "SQM," dated 2025, the SQM indicated, "Key points before TNK administration: Get the patient dose from the TNK dosing chart behind the stroke form. MAX DOSE IS 25 MG = 5 ML."
During a review of the facility's P&P titled, "Thrombolysis For Acute Ischemic Stroke," revision date 12/2/22, the P&P indicated, "E. Thrombolytic Administration: iii Calculate dose II. The maximum total dose of Tenecteplase for treatment of AIS is 25 mg."