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Tag No.: A0115
Based on staff interviews, review of one of one medical record (Patient (P) 1), review of facility documents, and review of American Heart Association guidelines, it was determined that the facility failed to ensure the rights of each patient is protected.
Findings include:
1. The facility failed to ensure that patients receive care in a safe setting. (Refer to Tag A 144)
Tag No.: A0144
Based on staff interview, review of one of one medical record (Patient (P) 1), review of facility documents, and review of American Heart Association (AHA) guidelines, it was determined that the facility failed to provide care in a safe setting by ensuring: 1) a cardiac monitor was applied to an obstetric patient who was in cardiopulmonary arrest; 2) an obstetric patient with neuraxial anesthesia [epidural analgesia] was monitored in accordance with anesthesia policies and procedures; and 3) a Martti (My Accessible Real-Time Trusted Interpreter) interpreter was utilized to facilitate communication between the patient and the health care provider during an epidural bolus injection.
Findings include:
1. Review of P1's medical record, in the presence of Staff #2, Staff #3, and Staff #4, revealed the following:
P1 was a 30-year-old female, G1P0 (Gravida [number of pregnancies] Para [number of viable births]), 39 weeks and 3 days gestation (time in womb between conception and birth), with an estimated due date of delivery of 8/13/22, who presented to the Labor and Delivery (L&D) Unit on 8/9/22 at 4:44 AM with a chief complaint of vaginal bleeding. During an interview on 8/31/22 at 11:07 AM, Staff #4, the Perinatal Services Manager, indicated that P1 was admitted in labor and was augmented (stimulating the uterus to increase contractions after the onset of spontaneous labor) with Pitocin (a medication to induce/augment labor).
Review of the "Anesthesia Procedure Note" dated 8/9/22 at 14:45 [2:45 PM] located in the "Anesthesia Information" section of the electronic medical record (EMR) indicated that at 14:20 [2:20 PM], P1 received an Epidural Block [a method of administering pain medication through the spinal cord] by Staff #12, an anesthesiologist, and P1's sensory level was documented as T10 [Thoracic 10].
The "Clinical Notes" dated 8/9/22 at 3:39 PM, entered by Registered Nurse (RN) 15, stated, "PT [Patient] c/o [complains of] numb chest, (physician name) [Staff #12] paged. (physician name) [Staff #6, an anesthesiologist] responded, will come to evaluate patient at bedside. O2 sat [oxygen saturation] 99, RR [Respirations] 20." The "Clinical Notes" dated 8/9/22 at 4:21 PM, entered by RN15, indicated that Staff #6 was in the room to evaluate P1.
At 19:45 [7:45 PM], the nursing flowsheet provider notification section states, "C/s [cesarean section] called by (physician name) [Staff #14]. Neonatologist, NICU [Neonatal Intensive Care Unit] RN, anesthesiologist, and first assist made aware. C/s will be for 2030 [8:30 PM]."
The Operative Note stated, " ...Procedure details: Cesarean section was called at approximately 7:45 PM secondary due to failure to dilate and descend. There were intermittent late decelerations in the presence of good variability as well as accelerations however Pitocin could not be maximized. C-section was called for these reasons. ... "
The "Clinical Notes" dated 8/9/22 at 8:50 PM, entered by RN15, stated, "2047 [8:47 PM] (physician name) [Staff #6], at bedside administering epidural bolus. Upon RN entering room at 2050 [8:50 PM], pt [Patient] noted unresponsive and cyanotic. no maternal carotid pulse palpated, FHR [Fetal Heart Rate] deceleration [drop in fetal heart rate] noted on monitor. Chest compressions initiated immediately, code called. (physician names) [Staff #12 and Staff #6] at bedside. ... "
At 9:00 PM, The Code Blue Note stated, "Code blue called at 852pm [8:52 PM], upon arrival ACLS [advanced cardiac life support] protocol was being followed. Patient was not given any medications. Chest compressions were started immediately upon Code Blue and patient was intubated [inserting a tube into the trachea for ventilation] by approximately 855pm [8:55 PM], Patient was immediately taken back for emergent cesarean section. Pulse was regained. The code was run by (5 physician names)."
On 8/31/22 at 11:07 AM, during an interview, Staff #4, the Perinatal Services Manager, indicated that no medications or shocks were administered during the code and that ROSC (Return of Spontaneous Circulation) was achieved at 9:01 PM.
At 21:02 [9:02 PM], the nursing flowsheet stated, "Pt [patient] transferred to OR [Operating Room] via labor bed. ... ." At 9:07 PM, the baby was delivered. At 21:45 [9:45 PM], the ETT (Endotracheal Tube) was removed and at 22:00 [10:00 PM] the patient was transferred directly to the Intensive Care Unit (ICU).
P1's medical record lacked evidence of a documented cardiac rhythm.
On 9/19/22 at 12:36 PM, Staff #2 confirmed that during the investigation of the incident, the primary RN validated that the code cart was brought into the patient's room within one minute by another RN on the L&D Unit, however the patient was not placed on the cardiac monitor and no rhythm strips were available until the patient was in the L&D Operating Room at approximately 2103 [9:03 PM].
Review of the policy titled "Cardiac Arrest - Adult & Pediatric" states, "...Procedure: ...Cardiac Arrest Responders ... 2. The resuscitation team will consist of: a. Leader - Family Practice Physicians/House Coverage LIP [Licensed Individual Practitioner] or Physician (Will be responsible for delegating responsibilities to all team members and ensuring that all resuscitation documentation is complete). ... 2. Acronyms: ... Cardio-Pulmonary Arrest ... Cardiac resuscitation is performed in accordance with American Heart Association guidelines for Basic Life Support (BLS) and advanced life support (ACLS)."
Review of the 2020 AHA Adult Cardiac Arrest Algorithm states, "1. Start CPR give oxygen attach monitor/defibrillator Rhythm shockable? ... "
Although "The Code Blue Note" indicated that upon arrival, ACLS protocol was being followed, the facility failed to ensure that P1 was placed on a cardiac monitor to determine if there was a shockable rhythm, in accordance with AHA guidelines.
2. Review of P1's medical record, in the presence of Staff #2, Staff #3 and Staff #4, revealed the following:
Review of the "Anesthesia Procedure Note" dated 8/9/22 at 14:45 [2:45 PM] located in the "Anesthesia Information" section of the EMR indicated that at 14:20 [2:20 PM], P1 received an Epidural Block by Staff #12, and P1's Sensory level was documented as T10.
The "Clinical Notes" dated 8/9/22 at 3:39 PM, entered by RN15, stated, "PT c/o numb chest, (physician name) [Staff #12] paged. (physician name) [Staff #6] responded , will come to evaluate patient at bedside. O2 sat 99, RR 20." The "Clinical Notes" dated 8/9/22 at 4:21 PM, entered by RN15, indicated that Staff #6 was in the room to evaluate P1.
The "Clinical Notes" dated 8/9/22 at 8:50 PM, entered by RN15, stated, "2047 [8:47 PM] (physician name) [Staff #6], at bedside administering epidural bolus. Upon RN entering room at 2050 [8:50 PM], pt noted unresponsive and cyanotic. no maternal carotid pulse palpated , FHR deceleration noted on monitor. Chest compressions initiated immediately, code called. (physician names) [Staff #12 and Staff #6] at bedside. ... "
The anesthesia "Events" Section dated 8/9/22 at 22:45 [11:45 PM] stated, "Memo Patient has been on the bupivacaine 0.1% [an anesthetic] epidural infusion since 15:00 [3:00PM] at rate of 10cc/hr [cubic centimeters/hour]. On call for a C/S the catheter was bolused with 10 ml [milliliters] of Bupivacaine 0.5% after aspiration and negative heme or csf [Cerebral Spinal Fluid], very shortly after patient became non responsive and a code was called. Chest compression was immediately started. Fear of intravascular injection of bupivacaine prompted the start of intravascular fat emulsion and immediate intubation. C/S was initiated and on inspection of the epidural catheter I realized that the CSF could be aspirated freely from the catheter so I diagnosed it as a high spinal block. ... "
Review of the facility document titled "Department of Anesthesiology Policies and Procedures" Revised 9/2016, stated, "... Labor and Delivery ... Obstetric Neuraxial [administration of medication into the subarachnoid or epidural space to produce anesthesia and analgesia] Anesthesia Policy ... 4. Monitoring for patients receiving epidural analgesia/anesthesia for labor include: ... C. Sensory level/patient comfort level checks shall be performed hourly by either an anesthesiologist or a qualified L&D nurse. ... Continuous Epidural Infusion Policy ... 3. Sensory level checks may be performed be either an Anesthesiologist or a qualified L&D nurse. A Qualified nurse is considered one who has seen or received the instructional information, passed a certifying examination and performed three (3) supervised level checks."
Review of the facility policy titled "Epidural Analgesia/Anesthesia - Management of the Pregnant Patient" Effective 10/11/2021, stated, "... Procedure: ... 11. Monitor for: ... b. High spinal: i. Assess for numbness or weakness of the upper extremities, dyspnea, weak speech or no speech, apnea, and/or loss of consciousness. ... " The policy did not include performing hourly sensory level checks.
P1's medical record lacked hourly sensory level/patient comfort level checks performed by either the anesthesiologist or the L&D nurse. On 9/19/22 at 12:36 PM, Staff #2 confirmed that the L&D nurses are not qualified to perform sensory checks, therefore the responsibility lies with the Anesthesiologist. Staff #2 indicated that during the investigation it was determined that there was a misalignment of the Anesthesia and Nursing Policies.
3. Review of P1's medical record, in the presence of Staff #2, Staff #3 and Staff #4, revealed the following:
Review of the "Anesthesia Procedure Note" dated 8/9/22 at 14:45 [2:45 PM] located in the "Anesthesia Information" section of the EMR indicated that at 14:20 [2:20 PM] P1 received an Epidural Block by Staff #12, and P1's Sensory level was documented as T10. The "Nursing Note" dated 8/9/22 at 2:58 PM located in the "Clinical Notes" section of the EMR stated, "AK 1184 Interpreter used for information regarding epidural. ... "
The "Clinical Notes" dated 8/9/22 at 3:39 PM, entered by RN15, stated, "PT c/o numb chest, (physician name) [Staff #12] paged. (physician name) [Staff #6] responded, will come to evaluate patient at bedside. O2 sat 99, RR 20." The "Clinical Notes" dated 8/9/22 at 4:21 PM], entered by RN15, indicated that Staff #6 was in the room to evaluate P1. Staff #6 reassured the patient and her husband via a qualified interpreter that examination findings regarding her sensation level were normal. Vital signs recorded at 1543 [3:43 PM] HR [Heart Rate] 105, BP [Blood Pressure] 127/65, 02 sat 97% on room air.
The "Clinical Notes" dated 8/9/22 at 8:50 PM, entered by RN15, stated, "2047 [8:47 PM] (physician name) [Staff #6], at bedside administering epidural bolus. Upon RN entering room at 2050 [8:50 PM], pt noted unresponsive and cyanotic. no maternal carotid pulse palpated , FHR deceleration noted on monitor. Chest compressions initiated immediately, code called. (physician names) [Staff #12 and Staff #6] at bedside. ... "
Facility document provided by Staff #2 stated, "... 8/12/22 - ... 07:55 - Note by (physician name) [Staff #6]-Prior to C/S I injected the epidural catheter with 10 ml of bupivacaine 0.5% in preparation for C/S and patient pointed at her nose. I assured her and positioned her in preparation for transport to the OR. I proceeded to do a final check of the OR. ... "
On 9/19/22 at 12:36 PM, Staff #2 confirmed that at 1915 [7:15 PM] the primary RN utilized the Martti interpreter for pre-operative teaching, nursing assessment and to conduct patient education and communicate the plan of care with the patient/family. However, there was no documentation in the medical record that indicated that a Martti interpreter was used to communicate with the patient/family, when the anesthesiologist administered the epidural bolus dose and the patient pointed to her nose.