HospitalInspections.org

Based on record review and interview the hospital failed to ensure pharmacy staff verified and emergency department (ED) nursing staff administered thrombolytic therapy (Activase - known as the clot buster) according to manufacturer's recommendations and national evidence based guidelines for stroke for a sample of one (Patient #13) of two ED stroke patient medical records reviewed.

This failed practice had the likelihood for one (Patient #13) of two stroke patients to have an increased risk for bleeding including intracranial bleed resulting in adverse patient health outcomes.

Findings:

Review of hospital policy titled "Computerized Provider Order Entry (CPOE) Process, revised 03/18" showed "all physician/provider orders are entered into the electronic medical record" ... "Nurses ...facilitate order entry when physician/provider is unable to electronically enter orders."

Review of hospital document titled "Rules and Regulations of the Medical Staff, dated 12/17" showed "practitioners must utilize the EMR (electronic medical record) for patient care documentation, including but not limited to CPOE ..."

Review of hospital policy titled "Stroke Team Response, dated 03/17" showed the Protocol for TPA/Activase infusion and TPA (tissue plasminogen activator) order sets were to be followed for patients receiving Activase.

Review of untitled hospital document provided by Staff W (Pharmacy) a screen shot of EPIC (electronic medical record system) which showed electronic order sets for acute ischemic stroke with individual orders for the IV infusion and the 10% IV bolus.

Review of document titled "Activase Prescribing" showed the recommended dose for acute ischemic stroke was 0.9 mg/kg not to exceed a total dose of 90 mg (regardless of patient's weight). The dose should be infused intravenously (IV) over 60 minutes with 10% of the total dose administered in an initial IV bolus over one minute.

Patient #13 was 46 year old male who arrived in the ED on 07/20/18 with sudden onset of headache, dizziness, imbalance, right sided numbness, tingling, weakness and difficulty speaking. Review of Patient #13's medical record showed the following:
*12:30 pm, Alteplase (Activase) 100mg infusion documented in the patient's medication administration record (MAR) as "medication given" by override pull.
*There was no evidence in the patient's EMR the Activase dose was calculated based on the patient's weight of 101 kg (222 lbs).
*There was no evidence Staff F (ED RN) and Staff V (ED RN) administered Activase in a 90mg (maximum dose based on patient's weight) dose with an IV infusion of 81 mg over 60 minutes and a 9 mg IV bolus over 1 minute.

On 08/09/18 at 8:57 am, Staff W stated emergent medication orders staff can override pull and when the order was entered into EPIC using the order set it would create a link back to the original drug. Staff W stated they would still then be able to scan the medication. Staff W stated Patient#13's MAR in the EMR showed 100mg was given as an infusion. Staff W stated the MAR did not show the Activase was given per manufacturer recommendations in a 10% bolus and 90% infusion.

On 08/08/18 at 11:59 am, Staff F (ED RN) stated he/she pulled the Activase from the medicine cabinet for Staff V (ED RN), he/she gave the medication and Staff F co-signed the administration. Staff F stated the patient's MAR should show the documentation of the bolus and infusion.

The hospital failed to ensure the patient's EMR (electronic medical record) reflected sufficient documentation by ED staff which included physical nursing assessment, interventions, treatments, responses to treatment, and any clinical changes in condition as evidenced by:

I. No documentation of a physician's order for thrombolytic therapy (Alteplase) which included calculation based on the patient's weight into a 10% bolus and a 90% infusion not to exceed a maximum dose of 90mg per manufacturer's recommendations for one (Patient #13) of two stroke patient charts reviewed.

This failed practice had the likelihood for one (Patient #13) of two stroke patients to have an increased risk for bleeding including intracranial bleed resulting in adverse patient health outcomes.

II. ED basic nursing assessments to ensure clinical condition and stability on admission, during admission and/or prior to transfer to another facility for a sample of five (Patient #29, 31, 32, 33 and 34) of 12 ED patient charts reviewed.

This failed practice had the likelihood to result in delayed patient care decisions due to the unavailability of pertinent health care information to make timely medical and nursing care decisions.

III. Neurological assessments following the administration of Activase for the treatment of acute stroke for one (Patient #13) of two stroke patient charts reviewed to monitor for clinical deterioritation prior to transfer.

Findings:

Review of hospital policy titled "Documentation of Patient Care, dated 04/16" showed all documentation should be done in the Electronic Health Record. Only exceptions should be when there was "not an electronic mechanism available for that clinical process".

Review of hospital policy titled "Computerized Provider Order Entry (CPOE) Process, revised 03/18" showed "all physician/provider orders are entered into the electronic medical record" ... "Nurses ...facilitate order entry when physician/provider is unable to electronically enter orders."


I. Physician Orders

Review of hospital document titled "Rules and Regulations of the Medical Staff, dated 12/17" showed "practitioners must utilize the EMR (electronic medical record) for patient care documentation, including but not limited to CPOE ..."

Review of hospital policy titled "Stroke Team Response, dated 03/17" showed the Protocol for TPA/Activase infusion and TPA (tissue plasminogen activator) order sets were to be followed for patients receiving Activase.

Review of hospital policy titled "Medication Administration & Self-Administered Medications, dated 07/18" showed medications to be administered were to be verified with a physician's order and given by qualified licensed staff.

Review of hospital document titled "Rules and Regulations ...Medical Staff, dated 12/12/17" showed medical staff were required to use the EMR including computerized order entry adhering to policies and procedures related to the EMR ...paper documentation should only be used when EMR was not available ...orders for medications were to include the name of the medication, route, dose, frequency, and directions for use.

Review of hospital document titled "Computerized Provider Order Entry (CPOE) Process, dated 03/18" showed nursing staff should facilitate order entry when physicians and/or providers are unable or unavailable to electronically enter orders. Prescribing physician or provider should make every effort to perform first hand order entry. Verbal orders should be entered electronically and include the name of the medication, strength, instructions for route, administration, physician/provider name and title, and name of nurse accepting and entering order.

Review of untitled hospital document provided by Staff W (Pharmacy) a screen shot of EPIC (electronic medical record system) which showed electronic order sets for acute ischemic stroke available for physician staff to order Alteplase (Activase) and automatically calculates infusion and bolus doses based off patient's weight entered in the EMR with a maximum dose limit of 90mg.

Review of document titled "Activase Prescribing" showed the recommended dose for acute ischemic stroke was 0.9 mg/kg not to exceed a total dose of 90 mg (regardless of patient's weight). The dose should be infused intravenously (IV) over 60 minutes with 10% of the total dose administered in an initial IV bolus over one minute.

Patient #13 was 46 year old male who arrived in the ED on 07/20/18 with sudden onset of headache, dizziness, imbalance, right sided numbness, tingling, weakness and difficulty speaking. Review of Patient #13's medical record showed the following:
*There was no evidence in the patient's EMR for an order showing the Activase dose was calculated based on the patient's weight of 101 kg (222 lbs).
*There was no evidence Staff O (ED physician) or Staff F (ED RN) entered an order for Activase 90mg (maximum dose based on patient's weight) dose with an infusion of 81 mg over 60 minutes and a 9 mg IV bolus over 1 minute.
*Evidence of paper order sets including "Acute Stroke Emergency Department Orders", "tPA (Activase) Telestroke Transfer Orders", and "Post-tPA (Activase) Telestroke Transfer Orders" were utilized. There was no evidence in these order sets for an order for the administration of Activase including the IV infusion and IV bolus based on patient's weight and maximum dose of 90 mg.

On 08/09/18 at 8:57 am, Staff W stated the pharmacy does not see paper orders very often anymore since the electronic medical record (EMR) was initiated. Staff W stated the only time paper orders were used was when EMR was down. Staff W stated Patient#13's medication administration record (MAR) in the EMR showed 100mg were given as an infusion. Staff W stated the MAR did not show the Alteplase was given per manufacturer recommendations in a 10% bolus and 90% infusion. Staff W stated there was no order or pharmacy verification. Staff W stated physicians were supposed to be using the order sets available in EPIC.

II. Nursing Assessments

Review of hospital policy titled "Patient Assessment/Reassessment, dated 09/16" showed reassessments of the patient should be performed at "regular intervals" to determine patient's "response to care/treatment". Reassessments should be documented.

Review of hospital policy titled "Guidelines for Nursing Process in the Emergency Department, dated 03/17" showed patients should have a complete assessment by body system and the RN should "observe and assess patients' needs and responses ..."

Review of a sample of five (Patient #29, 31, 32, 33 and 34) of 12 ED patient charts reviewed showed no evidence of a nursing assessment at the time of admission, during the patient's stay in the ED or at the time of transfer to ensure patient's clinical condition and stability.

On 08/07/18 at 2:58 pm, Staff A stated nursing assessment in the ED should include all major systems. Staff A stated he/she documented by "exception".

III. Neurological Assessments

Review of hospital policy titled "Stroke Team Response, dated 03/17" showed TPA order sets should be followed for the infusion of TPA/Activase.
Review of hospital document titled "Post-tPA (Activase) Telestroke Transfer Orders), dated 11/16" showed the patients receiving Activase should have their neurological status monitored using the modified NIHSS (National Institutes of Health Stroke Scale) "every 15 minutes for two hours, then every 30 minutes for six hours, then every one hour until after treatment ..."
Patient #13 was 46 year old male who arrived in the ED on 07/20/18 with sudden onset of headache, dizziness, imbalance, right sided numbness, tingling, weakness and difficulty speaking. Patient #13 received Activase at 12:30 pm by Staff V. There was no evidence the patient received every 15 minute modified NIHSS assessment for two hours and consistent 30 minute assessment until transfer after the administration of Activase. A full NIHSS was performed at 1:00 pm, and modified NIHSS were performed at 1:05 pm, 1:35 pm, and 2:15 pm. Patient was transferred to a higher level of care at 3:30 pm.

On 08/08/18 at 11:59 am, Staff F stated he/she would monitor the patient's neurological status "frequently" using the NIHSS following the administration of Activase. Staff F stated he/she could not say for sure how often the patient should be monitored per hospital policy or recommended guidelines.