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Based on interview and record review, the medical staff failed to: 1). intervene in a patient who was first assessed to be unresponsive after sedation, and 2). implement a quality assessment and performance improvement program after an adverse incident involving one sampled patient (SP #1) of eleven sampled patients.

The findings include:

1). Review of the facility's Bylaws, dated 07/01/13, stated that each medical staff member must provide appropriate, timely, and continuous care to his/her patients. The Bylaws also stated that members of the Active Staff shall retain full responsibility within their area of professional competence and pursuant to their privileges for the continuous care and supervision of their patients in the Medical Center or arrange a suitable alternative for such care and supervision.

Review of SP#1 medical record showed that the patient was admitted as an inpatient to the facility on 09/29/14. On 09/29/14 at 12:00 PM, the patient's blood pressure (BP) was 159/72 mmHg (millimeters of mercury). On 09/30/14 at 12:25 PM, the patient had an angiogram in the cardiovascular lab. On 10/01/14 at 2:49 PM, a left superficial femoral and popliteal artery atherectomy and stent (treat blockages), and left superficial femoral artery mechanical thrombectomy (removal of a clot) was completed in which tPA (tissue plasminogen activator) was used.

On 10/01/14 at 4:30 PM, Post- operative assessment showed that the patient was sedated. On 10/01/14 at 5:30 PM, the BP was 202/91 mmHg and Nitroglycerin (Nitro) drip was started. On 10/01/14 from at 5:45 PM to 7:30 PM, the patient's BP ranged from 165/120 mmHg to 215/81 mmHg.


The nursing notes on 10/02/14 at 12:28 AM stated, a RRT (Rapid Response Team) was called for (SP#1) patient pt unresponsiveness. RN (Registered Nurse) state that pt came back from procedure (C. cat) [Cardiac Cath] unresponsiveness to verbal and painful stimuli. During procedure pt received 4 mg (milligram) of Versed and 75 mcg (microgram) of Fentanyl. Narcan and Romazicon were given and pt remains unresponsive. [Name of Attending Physician] paged and made aware of situation. Stated that pt is oversedated and brain CT is not needed at this time. Updated on Narcan and Romazicon given and still remains unresponsive. The Surgical residents are at bedside and updated on events. Stated that pt is oversedated. Made aware of reversal agents given without any response, no CT ordered at this time.

The physician notes on 10/02/14 at 7:50 AM, stated that SP #1 has been very somnolent since yesterday after intervention and was still unresponsive. "Review of the Physician ordered showed that a consult of neurology was ordered on 10/02/14 at 8:07 AM. On 10/02/14 at 9:07 AM, the Neurologist assessed the patient. A Computed tomography (CAT scan) of the head/brain was then ordered.
The CT (scan) of the brain completed on 10/02/14 at 10:26 AM reported an intraparenchymal hematoma, subarachnoid hemorrhage in the bilateral hemispheres, and loss of gray matter consistent with recent infarction. The surgical consult notes on 10/02/14 at 12:24 PM stated that neurosurgical intervention will not improve the patient's outcome, as she has suffered an irreversible brainstem injury


On 12/08/14 at 3:11 PM, the Assistant Vice-President, Risk Management stated that even though only 20 mg of tPA was given and then taken out, that tPA can have adverse effects such as intracranial bleed.

On 12/09/14 at 2:52 PM, Staff H, Surgical Resident, stated that he responded to SP#1 rapid response. He stated that the patient was sleeping and did not wake up after about six hours after a procedure. Staff H stated that he saw the patient and ordered Romazicon and Flumazenil. He stated that after he assessed the patient, he went to call his senior physician who came down and re-assessed the patient. Staff H stated that SP#1 was still not responding after they did sternal rub. He stated that SP#1 was given 4 mg of Versed and he figured she was oversedated. He stated that after the reversal medications were given, the patient's response to the medications should have been quick. Staff H stated that the physicians could have ordered a CT scan earlier.


On 12/09/14 at 12:00 PM, Staff I, Surgical Resident, stated that he did not respond to SP#1 rapid response. He stated that he saw SP#1 in the morning and the patient was still unresponsive because she received tPA. He stated that he doesn't know if a CT could have helped because of the bleed.

The risk factor for hemorrhagic stroke included high blood pressure. The literature showed that tPA is a thrombolytic that is used to dissolve clots. Potential complication of thrombolytic administration is hemorrhage in the brain, genitourinary and gastrointestinal tracts. Any significant change in the patient's neuro status may be indicative of an intra-cerebral bleed. A Stat CT scan must be done which can confirm the presence or absence of bleeding. The literature also showed that after the administration of thrombolytics (which includes tPA), elevated blood pressure can cause bleeding in the brain.


2.) Review of facility's record did not show that the Cardiovascular Lab (CVL) Registered Nurse's or the physicians and resident's have completed any updated education/inservices on tPA administration and monitoring.

On 12/08/14 at 3:11 PM, the Assistant Vice-President, Risk Management stated that after review of SP#1 case the physicians have not yet been educated on the changes to the consent form. The Assistant Vice-President, Risk Management stated that an in-service on tPA is going to be presented by the pharmacy department to the CVL staff. The in-service has not yet been presented and will be completed in no longer than 30 days. She stated that even though only 20 mg of tPA was given and then taken out, that tPA can have adverse effects such as intracranial bleed.

Based upon interviews and record review, the Nursing Staff failed implement a plan to: 1). Administer Hydralazine to a patient with an elevated blood pressure. 2). Titrate the Nitroglycerin drip for a patient with an elevated blood pressure and 3). Call the rapid response team for a patient with elevated blood pressure and change in mental status in one Sampled Patient (SP) #1) of twenty-two sampled patients.

The findings include:


1). Review of sampled patient (SP)#1 medical record showed that the patient was admitted as an inpatient to the facility on 09/29/14. Review of the Physician orders showed that on 09/29/14, the patient was ordered Hydralazine 50 mg (milligrams) every 8 hours for hypertension. Review of the Medication Administration Record (MAR) showed that on 09/30/14 at 9:00AM and 10:00 PM, and on 10/01/14 at 6:00 AM, the patient ' s scheduled doses of Hydralazine 50 mg tablet was not administered. The reason for non-administration was "order parameter not met."

On 12/08/14 at 11:10AM, Staff A (RN) stated that if the BP if elevated above 160 (systolic blood pressure), then she would ask the patient if they took the morning medication and if not she would call the doctor to order medication.
On 12/09/14 at 9:45AM, Staff A stated that when patients are ordered NPO (nothing by mouth) except medications, scheduled anti-hypertensive is given.

On 12/08/14 at 11:40AM, Staff C-RN stated that if the BP is high, the RN looks at what the patient ' s baseline was, check the medications, and let the physician know that the patient's blood pressure was high. Staff C also stated that if the patient had a change in mental status, the physician is notified and an incident report completed

2). The patient's medical record showed that on 10/01/14 at 5:30 PM, SP#1's blood pressure (BP) was 202/91 mmHg and Nitroglycerin (Nitro) drip was started. The nursing notes on 10/01/14 at 5:45 PM stated that the patient's BP was 165/120 mmHg. Review of the MAR showed that the ordered Nitro drip range dose was 1.5-15 ml/hr (milliliters/ per hour) and increase 1.5 ml to 3 ml every three to five minutes based on the patient's response. At 6:30 PM, BP was 208/87 mmHg. At 7:00 PM the BP was 215/81 mmHg. Review of the patient's medical record did not show that the Nitroglycerin drip was increased.


On 12/08/14 at 11:10 AM, Staff A-RN (Registered Nurse) stated that a Nitro drip is titrated every 15 minutes and if the blood pressure remains high, the nitro dose is increased. Staff A stated that if the BP is 160 (systolic), the physician is called for PRN (as needed) medications, and if there is no parameters ordered and the blood pressure is high, it is best to call the physician.

On 12/09/14 at 10:06AM, Staff F, the Pharmacist stated that Nitro drip can be titrated every three to five minutes to achieve the blood pressure goal.

Review of the facility ' s policy titled, Medication Administration, reviewed on 09/14, showed that medications that prescribed more frequently than daily, but no more than every 4 hours must be administered one hour before or one hour after scheduled time. All medications administered shall be recorded on the electronic medical record.

3). Sampled Patient # 1 Nursing Assessments notes dated from 09/30/14 at 10:19 PM to 10/01/14 at 12:09 PM that the patient was awake, alert, and oriented x 4. The record then showed on 10/01/14 after cardiovascular lab procedure the patient's remained sedated and unresponsive. The medical record did not show that the Rapid Response Team was activated, or that a change in condition report was completed while the patient was in the cardiovascular lab.

On 12/08/14 at 11:30 AM, Staff B- RN stated that for unconscious patients, a code blue or stroke alert is called. He stated that for unconscious patients, the Cath lab staff will call for a CT (computed tomography) scan and take the patient to radiology.



Review of the facility ' s policy titled, Rapid Response Team, reviewed on 08/13, showed that upon arrival to CVL (cardiovascular Lab) Recovery Area monitoring will include vital signs, cardiac rhythm, oxygen saturation, pain, level of consciousness and Aldrete score at least every 15 minutes and with any changes in patient status and /or nursing intervention, until the patient has met discharge criteria or as per the physician. Readiness for discharge is based on pre-procedure baseline assessment: a) when patient has recovered from moderate sedation and is oriented to person, place and day or baseline status. B). patient demonstrates stability of vital signs for at least 30 minutes. C). Aldrete scores of 8-10 are considered satisfactory or same as pre-procedure status.

Review of the facility ' s policy titled, Rapid Response Team, reviewed on 08/13, showed that Rapid Response should be utilized to prevent crises from escalating. The policy showed that criteria for calling a rapid response included systolic blood pressure greater than 200, diastolic blood pressure greater than 110 and acute changes in level of consciousness.

Based upon interviews and record review, the Nursing Staff failed to: 1). Administer Hydralazine to a patient (SP#1) with an elevated blood pressure as ordered by physician. 2). Titrate the Nitroglycerin drip for a patient with an elevated blood pressure in one Sampled Patient (SP) (#1) of twenty-two sampled patients.


The findings include:

1). Review of sampled patient (SP)#1 medical record showed that the patient was admitted as an inpatient to the facility on 09/29/14. Review of the Physician orders showed that on 09/29/14, the patient was ordered Hydralazine 50 mg (milligrams) every 8 hours for hypertension. Review of the Medication Administration Record (MAR) showed that on 09/30/14 at 9:00 AM and 10:00 PM, and on 10/01/14 at 6:00 AM, the patient's scheduled doses of Hydralazine 50 mg tablet was not administered. The reason for non-administration was "order parameter not met."

On 12/08/14 at 11:10 AM, Staff A (RN) stated that if the BP if elevated above 160 (systolic blood pressure), then she would ask the patient if they took the morning medication and if not she would call the doctor to order medication.

On 12/09/14 at 9:45 AM, Staff A stated that when patients are ordered NPO (nothing by mouth) except medications, scheduled anti-hypertensive is given.

On 12/08/14 at 11:40 AM, Staff C-RN stated that if the BP is high, the RN looks at what the patient ' s baseline was, check the medications, and let the physician know that the patient's blood pressure was high. Staff C also stated that if the patient had a change in mental status, the physician is notified and an incident report completed

2). The patient's medical record showed that on 10/01/14 at 5:30 PM, SP#1's blood pressure (BP) was 202/91 mmHg and Nitroglycerin (Nitro) drip was started. The nursing notes on 10/01/14 at 5:45 PM stated that the patient's BP was 165/120 mmHg. Review of the MAR showed that the ordered Nitro drip range dose was 1.5-15 ml/hr (milliliters/ per hour) and increase 1.5 ml to 3 ml every three to five minutes based on the patient's response. At 6:30 PM, BP was 208/87 mmHg. At 7:00 PM the BP was 215/81 mmHg. Review of the patient's medical record did not show that the Nitroglycerin drip was increased.


On 12/08/14 at 11:10 AM, Staff A-RN (Registered Nurse) stated that a Nitro drip is titrated every 15 minutes and if the blood pressure remains high, the nitro dose is increased. Staff A stated that if the BP is 160 (systolic), the physician is called for PRN (as needed) medications, and if there is no parameters ordered and the blood pressure is high, it is best to call the physician.

On 12/09/14 at 10:06 AM, Staff F, the Pharmacist stated that Nitro drip can be titrated every three to five minutes to achieve the blood pressure goal.

Review of the facility ' s policy titled, Medication Administration, reviewed on 09/14, showed that medications that prescribed more frequently than daily, but no more than every 4 hours must be administered one hour before or one hour after scheduled time. All medications administered shall be recorded on the electronic medical record.