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BETH ISRAEL DEACONESS MEDICAL CENTER 330 BROOKLINE AVENUE BOSTON, MA 02215 Dec. 10, 2019
VIOLATION: NURSING SERVICES Tag No: A0385
The Hospital was out of compliance with the Condition of Participation for Nursing Services.

Findings included:

The Hospital failed to promote safety in the administration of medications to hospital patients by not requiring administration in accordance with accepted standards of practice and medical staff approved policies and procedures

Refer to TAG: A-0405.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on records reviewed and interviews, the Hospital failed to promote safety in the administration of medications to hospital patients by not requiring administration in accordance with accepted standards of practice and medical staff-approved policies and procedures.

Findings included:

The Hospital document titled Medication Administration Policy, dated 10/2017, indicated that all prescribed drugs shall be administered by an authorized licensed professional utilizing the five rights of medication administration: Right patient, Right medication, Right dose, Right route, and Right time. The policy also indicated that if medication is not given, note time, indicate reason, and notify the 24/7 Critical Result Contact as appropriate.

1. Patient #1's medical record indicated that, on 11/05/19, Patient #1 experienced chest pain, body shakes, and severe abdominal pain after scheduled medication administration. Patient #1 continued to have abdominal pain and experienced a near syncopal event with hypotension (systolic blood pressure readings in the 60s), temperature of 103, pulse oximeter reading of 89% on room air, and a heart rate of 127. Patient #1 was transferred to the intensive care unit for concern of septic shock.

The Hospital document titled Medication Fluid Event dated, 12/06/19, indicated that after Patient #1 experienced chest pain, body shakes, and severe abdominal pain after his/her medication administration on 11/05/19. Patient #1 reported to Nurse #2 that Nurse #1 administered liquid Tylenol into his/her tunneled central line. Nurse #2 notified Patient #1's physician immediately.

During an interview on 12/06/19 at 7:37 A.M., Nurse #2 said that Nurse #1 was a new hire to her floor and she was her preceptor. Nurse #2 said that, on 11/05/19, she received report from Nurse #1 at 6:00 P.M. and took over her care. Nurse #2 said that Patient #1 felt faint at 6:00 P.M. Nurse #2 said that she pulled the emergency alarm and staff arrived to assist. Nurse #2 said that she then alerted the physician. Nurse #2 said that Patient #1's blood pressure remained low (systolic pressure in the 70s) until 9:00 P.M. and he/she developed a fever of 103. Nurse #2 said that, at 9:00 P.M., Patient #1 said that he/she observed Nurse #1 trying to push liquid Tylenol into his/her central line. Nurse #2 then called Nurse #1 at home to confirm if liquid Tylenol was administered through Patient #1's central line. Nurse #2 said that Nurse #1 confirmed that she administered six mls of liquid Tylenol into the central line. Nurse #2 said that Nurse #1 stopped because it was too hard to administer the full dose (30mls). Nurse #2 said that Nurse #1 said that she threw the rest of the medications in the trash. Review of the Medication Administration Record indicated that Nurse #1 gave a full dose and there was no record of an incomplete dose or medication that was wasted.

During an interview on 12/06/19 at 9:00 A.M., the Nursing Director said that the Hospital started a new nursing program that would assist nurses who had their Associates Degree in Nursing obtain a Bachelors Degree in Nursing. The program consisted of a cohort of 12 Associate Degree nurses who were already licensed as Registered Nurses. The Nursing Director said that these nurses had limited nursing experience but were all assigned preceptors to assist them during the program. The Nursing Director said that Nurse #1 was signed off on independent medication administration and could administer medications independently. The Nursing Director acknowledged that Nurse #1 administered liquid Tylenol through Patient #1's central line and that an incomplete dose was not documented.

During an interview on 12/06/19 at 11:30 A.M., the Quality Director said that the Hospital's corrective measures included a review of the incident, interview with Nurse #1 and the Hospital accepting Nurse #1's resignation. The Quality Director said that the other 11 members of the cohort were not interviewed about their understanding of medication administration. The Quality Director said that the Hospital did not re-educate any nurses about medication administration or the appropriate steps to waste a medication.

2. Review of Patient #2's medical record indicated that Patient #2 presented to the Emergency Department (ED) on 11/08/19 with altered mental status. A Code Stroke was called and stat imaging revealed a right internal carotid artery stroke (stroke caused by a blood clot). An order was placed by the ED Physician for Patient #2 to receive tissue plasminogen activator (tPA-a medication that breaks down a clot). After reviewing the images the Interventionalist decided to take Patient #2 for a thrombectomy (an interventional procedure to remove a blood clot from a blood vessel) instead of starting tPA. The tPA was not cancelled. The tPA was administered after the thrombectomy although it was contraindicated.

The Hospital document titled Medication Fluid Event, dated 11/8/19, indicated that Patient #2 underwent a thrombectomy on 11/08/19 for an embolic stroke. Prior to the thrombectomy, the ED Physician ordered tPA to be administered intravenously. Although the decision to perform a thrombectomy was made, the tPA order was not canceled and remained an active order. After the thombectomy, Patient #2 was brought to the Post Anesthesia Care Unit (PACU). The procedural nurse gave report to the PACU nurse and, after the handoff report, the PACU nurse was unclear which physician was covering Patient #2, was unaware that the thrombectomy was only partially successful and was unaware how to proceed with the tPA order.

During an interview on 12/09/19 at 8:00 A.M., the Neurology fell ow said that he was involved with Patient #2's care on 11/08/19. The Neurology fell ow said that, after the thrombectomy procedure and prior to going to PACU, Patient #2 underwent a Computed Tomography (CT) scan which showed some bleeding from the intracranial vessels that were treated for thrombectomy. The Neurology fell ow said that this bleeding is not unusual and was to be monitored post procedure. The Neurology fell ow said that the tPA should have been cancelled once the decision was made to perform a thrombectomy. The Neurology fell ow said that tPA is contraindicated with any bleeding and is also contraindicated to be used after thrombectomy.

During an interview on 12/09/19 at 9:15 A.M., the PACU nurse said that she received report from the procedural nurse after Patient #2's thrombectomy. The PACU nurse said that the procedural nurse was not sure which physician was assuming care of Patient #2 and was unaware that the thrombectomy was only partially successful. The PACU nurse said that she was unaware that Patient #2 was still experiencing some intracranial bleeding and that the tPA was contraindicated. The PACU nurse said she administered the tPA intravenously. The PACU nurse said that she administered the tPA because the order was active and not cancelled.

During an interview on 12/06/19 at 11:30 A.M., the Quality Director said that the Hospital's corrective measures included a stop order before administration of tPA. Nurses would be alerted to contact the Neurologist before administering the medication. The lack of vital communication during nursing handoff (procedure outcome, physician coverage) and the lack of knowledge about contraindications to medication (tPA) were not addressed by Quality or Nursing.
VIOLATION: QAPI Tag No: A0263
The Hospital was out of compliance for Quality Assessment and Performance Improvement (QAPI) .

Findings include:

The Hospital failed, for two (Patients #1 and #2) patients out of ten sampled patients, to ensure that Quality Assessment and Performance Improvement (QAPI) activities included feedback and learning throughout all Nursing Services provided in the Hospital following Patients #1 and #2's adverse patient events.

Refer to TAG: A-0286.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on records reviewed and interviews, the Hospital's Quality Assessment and Performance Improvement (QAPI) Program failed to ensure a thorough internal investigation after Patient #1 and Patient #2's medication errors.

Findings included:

1. The Admission Documentation, dated 10/21/19, indicated Patient #1 was admitted for abdominal pain, nausea, and vomiting. On 11/05/19, Patient #1 experienced chest pain, body shakes, and severe abdominal pain after scheduled medication administration. Patient #1 continued to have abdominal pain and experienced a near syncopal (fainting) event with hypotension (systolic blood pressure readings in the 60s), temperature of 103, pulse oximeter reading of 89% on room air, and a heart rate of 127. Patient #1 was transferred to the intensive care unit for concern of septic shock.

The Hospital document titled Medication Fluid Event, dated 12/06/19, indicated that after Patient #1 experienced chest pain, body shakes, and severe abdominal pain after his/her medication administration on 11/05/19, Patient #1 reported to Nurse #2 that Nurse #1 administered liquid Tylenol into his/her tunneled central line. Nurse #2 notified Patient #1's physician immediately.

During an interview on 12/06/19 at 7:37 A.M., Nurse #2 said that she was taking care of Patient #1 on the evening of 11/05/19. Nurse #2 said that Nurse #1 was a new hire to her floor and she was her preceptor. Nurse #2 said that she had been precepting Nurse #1 for 11-12 weeks and that Nurse #1 was administering medication independently. Nurse #2 said that, on 11/05/19, she received report from Nurse #1 at 6:00 P.M. and took over her care. Nurse #2 said that Patient #1 felt faint at 6:00 P.M. while using the restroom. Nurse #2 said that she pulled the emergency alarm and staff arrived to assist Patient #1 to bed. Nurse #2 said that she then alerted the physician. Nurse #2 said that Patient #1's blood pressure remained low until 9:00 P.M. despite interventions and then Patient #1 developed a fever of 103. Nurse #2 said that, at 9:00 P.M., Patient #1 said that he/she observed Nurse #1 trying to push liquid Tylenol into his/her central line. Nurse #2 then called Nurse #1 at home to confirm if liquid Tylenol was administered through Patient #1's central line. Nurse #2 said that Nurse #1 confirmed that she administered six mls of liquid Tylenol into the central line. Nurse #2 said that Nurse #1 stopped because it was too hard to administer the full dose (30mls). Nurse #2 said that Nurse #1 said that she threw the rest of the medications in the trash. Review of the Medication Administration Record indicated that Nurse #1 gave a full dose and there was no record of an incomplete dose or medication that was wasted.

During an interview on 12/06/19 at 9:00 A.M., the Nursing Director said that the Hospital started a new nursing program that would assist nurses who had their Associates Degree in Nursing obtain a Bachelors Degree in Nursing. The program consisted of a cohort of 12 Associate Degree nurses who were already licensed as Registered Nurses. The Nursing Director said that these nurses had limited nursing experience but were all assigned preceptors to assist them during the program. The Nursing Director said that Nurse #1 was signed off on independent medication administration and could administer medications independently. The Nursing Director acknowledged that Nurse #1 administered liquid Tylenol through Patient #1's central line.

During an interview on 12/06/19 at 11:30 A.M., The Quality Director said that the Hospital's corrective measures included a review of the incident, interview with Nurse #1, and the Hospital accepting Nurse #1's resignation. The Quality Director said that the other 11 members of the cohort were not interviewed about their understanding of medication administration. The Quality Director said that the Hospital did not re-educate any nurses about medication administration or the appropriate steps to waste a medication.

2. Medical record review indicated that Patient #2 presented to the Emergency Department (ED) on 11/08/19 with altered mental status. A Code Stroke was called and stat imaging revealed a right internal carotid artery cut off (indicative of a stroke caused by a blood clot). An order was placed by the ED Physician for Patient #2 to receive tissue plasminogen activator (tPA-a medication that breaks down a blood clot). After reviewing the images the Interventionalist decided to take Patient #2 for a thrombectomy (an interventional procedure to remove a blood clot from a blood vessel) instead of starting tPA.

The Hospital document titled Medication Fluid Event, dated 11/8/19, indicated that Patient #2 underwent a thrombectomy on 11/08/19 for an embolic stroke. Prior to the thrombectomy the ED Physician ordered tPA to be administered intravenously. Although the decision to perform a thrombectomy was made, the tPA order was not canceled and remained active. After the thombectomy, Patient #2 was brought to the Post Anesthesia Care Unit (PACU). The procedural nurse gave report to the PACU nurse. After the handoff report, the PACU nurse was unclear which physician was covering Patient #2, was unaware that the thrombectomy was only partially successful, and was unaware how to proceed with the tPA order.

During an interview on 12/09/19 at 8:00 A.M., the Neurology fell ow said that he was involved with Patient #2's care on 11/08/19. The Neurology fell ow said that, after the thrombectomy procedure and prior to going to PACU, Patient #2 underwent a Computed Tomography (CT) scan which showed some bleeding from the intracranial vessels. The Neurology fell ow said that this bleeding is not unusual and would be monitored post procedure. The Neurology fell ow said that tPA is contraindicated with any bleed and is also contraindicated to be used after thrombectomy.

During an interview on 12/09/19 at 9:15 A.M., the PACU nurse said that she received report from the procedural nurse after Patient #2's thrombectomy. The PACU nurse said that the procedural nurse was not sure which physician was assuming care of Patient #2 and was unaware that the thrombectomy was only partially successful. The PACU nurse said that she was unaware that Patient #2 was still experiencing some intracranial bleeding and that the tPA was contraindicated.

During an interview on 12/06/19 at 11:30 A.M., the Quality Director said that the Hospital's corrective measures included a stop order before administration of tPA. Nurses would be alerted to contact the Neurologist before administering the medication. The lack of vital communication during nursing handoff (procedure outcome, physician coverage) and the lack of knowledge about contraindications to medication (tPA) were not addressed by Quality or Nursing.