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The Condition of Participation for Medical Staff has not been met.


Based on medical record review, review of facility policies, review of facility documentation and interviews for one of three patients (P #1) who had a Cesarean (C)-section, the facility failed to ensure that the physician (MD #1) was compliant with medical staff bylaws, rules and regulations, and facility policies related to accurate and timely assessment and treatment.

Please see A 347

Based on medical record review, review of facility policies, review of facility documentation and interviews for one of three patients (P #1) who had a Cesarean (C)-section, the facility failed to ensure that the physician (MD #1) assessed fetal tracings accurately and performed the C- section timely. The finding includes:

Patient (P) #1 was Gravida, 1 Para 0, and was admitted to the hospital by P #1's attending physician, Medical Doctor (MD) #1, on 7/3/20 for labor augmentation and planned vaginal delivery of P#2. P #2 was delivered at 41 weeks, 4 days gestational age. Physician orders dated 7/4/20 directed Oxytocin IV (intravenous) 30 units in 500 milliliters (ml.) of normal saline with a starting dose of 1 milliunit (mU)/minute (min), increase by 1 mU/min every 30 minutes, not to exceed 20 mU/min. The Pitocin/Oxytocin administration record identified that the Pitocin was started on 7/4/20 at 8:42 AM as ordered. Pitocin/Oxytocin is used to increase the strenth of uterine contractions to augment labor.

Fetal tracings dated 7/4/20 from 5:48 PM to 6:29 PM identified a base FHR (fetal heart rate) of 150-160 bpm (beats per minute), MD #1's progress note dated 7/4/20 at 6:29 PM incorrectly indicated a base fetal heart rate (FHR) of 130 to 140 bpm. Labor monitoring strips noted that P #1 had a temperature of 99.5 degrees F (Fahrenheit) on 7/4/20 at 7:05 PM and MD #1 was aware. The medical record failed to indicate that a change in the plan of care was directed by MD #1 at that time.

Review of fetal tracings dated 7/4/20 and interview with Registered Nurse (RN) #2 on 7/28/20 at 10:00 AM noted that tracings from 8:06 PM to 8:12 PM showed late non- reassuring (an abnormal fetal heartrate requiring intervention to rule out fetal acidosis) decelerations (decrease in the fetal heartrate below the fetal baseline with time from onset to the point of lowest being >30 seconds) followed by a prolonged deceleration with non-reassuring fetal tachycardia, MD #1 reviewed the tracing and ordered that the Pitocin continue infusing (against facility policy). MD #1's progress note dated 7/4/20 at 8:37 PM incorrectly indicated FHR "140's" and did not identify the non- reassuring tracings. The medical record failed to indicate that a change in the plan of care was directed by MD #1 at that time.

Labor monitoring strips dated 7/4/20 identified that P #1 was fully dilated at 9:09 PM, P #1 began pushing with every contraction (tightening of uterine muscle fibers that occur briefly and intermittently throughout labor) and P #2's fetal heart tracing showed tachycardia with a baseline FHR of 180's-190's after 10:04 PM, and deep variable decelerations with every push (all non- reassuring). The labor monitoring strip noted that MD #1 performed a vaginal exam at 10:46 PM and MD #1 incorrectly documented that the FHR was 160's and did not document the non- reassuring fetal heart tracings. The medical record failed to indicate that a change in the plan of care was directed by MD #1 at that time.

Labor monitoring strips identified that the deep variable prolonged decelerations (non- reassuring), with pushing occurred consistently following the vaginal exam, MD #1 was called to review the tracings at 1:07 AM on 7/5/20, and was at the bedside at 1:08 AM to 1:27 AM attempting to deliver P #2 vaginally. The decision for C-section delivery was made by MD #1 and documented at 1:27 AM (greater than 4 hours of category II tracings).

P #2 was born on 7/5/20 at 2:01 AM via C-section. P #1's operative report dated 7/5/20 by MD #1 identified that P #2's head was wedged into P #2's pelvis with nuchal cord x 2 (cord wrapped around the neck x 2) and cord blood gases were unable to be obtained. P #2's delivery room assessment dated 7/5/20 identified that P #2 was blue or pale with Apgar scores of "0" at 1 minute, and "5" at 10 minutes of life.

P #2's resuscitation record dated 7/5/20 noted that resuscitative efforts were initiated at 2:02 AM and a LMA (laryngeal mask airway) was eventually placed at 2:15 AM (14 minutes of life) following multiple, difficult intubation attempts (x 5) with an ETT (endotracheal tube) by Physicians Assistant (PA) #1 and Anesthesiologist #1. P #2 was subsequently intubated by Anesthesiologist #1 at 2:25 AM, placed on a ventilator, and required transfer to Hospital #2 for brain cooling. The initial arterial blood gas identified a PH of 6.92 (normal range = 7.38 to 7.42) and a CO2 level of 44 (normal range = 38- 42),

P #2's discharge summery from Hospital #2 dated 7/7/20 identified that P #2 had severe metabolic acidosis, a large subgaleal hematoma, multiple acute bilateral cerebral infarcts, questionable left parietal skull fracture, and hypoxic ischemic encephalopathy. Following the decision for comfort measures, P #2 expired on 7/7/20.

Interview with MD #1's Legal Council on 7/30/20 at 10:26 AM indicated that MD #1 was unavailable for interview.

Interview with MD #3 (Neonatologist) on 7/24/20 at 9:00 AM noted that P #2's first blood gas result (severe acidosis) indicated that fetal hypoxia had been going on for some time and not just at the time of birth.

Interview with MD #2 on 7/24/20 at 7:30 AM, who had reviewed the case, identified that the decision to continue Pitocin was an error in judgment and added one more stressor to the baby who was already showing signs of not tolerating the labor. MD #2 further indicated that the fetal tracings reviewed did not match with what MD #1 documented in her notes and it was difficult to follow what MD #1 was thinking. MD #2 noted that given the presence of an indeterminate FHR baseline, decelerations and tachycardia, the decision to perform a C-section should have been made by MD #1 around 8:30 PM on 7/4/20 (delivery occurred on 7/5/20 at 1:27 AM).

The facility failed to accurately assess the patient and implement additional interventions timely.

The hospital policy entitled Labor Induction or Augmentation identified that in the case of tachysystole or category 2 or 3 fetal heart rate, Oxytocin was to be discontinued.

The hospital policy entitled Second Stage of Labor Management noted absence fetal heart monitoring baseline variability, or recurrent late decelerations, or a failure to establish an appropriate baseline with rest should result in efforts to significantly expedite the delivery. This includes the consideration of a cesarean section if appropriate.

The Hospital Medical Staff Bylaws identified that the Attending Physician will be responsible for the medical care and treatment of the patient while in the hospital.

Subsequent to the event. The facility submitted an immediate action plan to include a root cause analysis which was in progress at the time of the investigation, and peer review of the event. The facility was found to be compliant with the plan as submitted. MD #1 sent a letter of notice of retirement to Hospital #1 effective 7/7/20.

The Condition of Participation for Nurses Services has not been met.

Based on medical record review, review of hospital policies, review of facility documentation and interviews for three of three patients who had Oxytocin (Pitocin) medication administration (P #1, P #3 and P #5), the hospital failed to ensure that the Pitocin policy was followed and that interventions were implemented and documented.

Please see A395

1. Based on medical record review, review of hospital policies, review of facility documentation and interviews for three of three patients who had Oxytocin (Pitocin) medication administration (P #1, P #3 and P #5), the hospital failed to ensure that the Pitocin policy was followed and that interventions were implemented and documented. The finding includes:

a. Patient (P) #1 was Gravida 1, Para 0, and was admitted to the hospital on 7/3/20 for labor augmentation and vaginal delivery.

Physician orders dated 7/4/20 directed Oxytocin IV (intravenous) 30 units in 500 milliliters (ml.) of normal saline with a starting dose of 1.0 milliunit (mu)/minute (min.) increase by 1.0 mU/min. every 30 minutes not to exceed 20 mu/min.

The Pitocin administration record identified that the Pitocin was started on 7/4/20 at 8:42 AM, as ordered, and was at a rate of 2.0 mU/min at 4:15 PM.

Review of labor monitoring strips and nursing documentation additional with Director #1 on 7/23/20 at 11:10 AM indicated that tachysystole (>5 contractions within 10 minutes) and fetal tachycardia (HR>160 bpm) were noted beginning at 4:41 PM on 7/4/20 and although Registered Nurse (RN) #1 informed Medical Doctor (MD) #1, additional interventions were not documented by RN #1. According to Director #1, RN #1 should have turned the Pitocin off at that time as identified in hospital policy.

Further review of labor monitoring strips with Director #1 noted that coupling contractions (presence of 2 or more successive contractions without return to baseline between contractions) and a late deceleration were noted at 4:50 PM and 4:56 PM consecutively, followed by long contractions (tightening of uterine muscle fibers that occur briefly and intermittently throughout labor) and minimal fetal heart rate variability. Director #1 identified that interventions to include repositioning and fluid bolus should have been instituted by RN #1 and were not documented as done.

The Pitocin administration record identified that the Pitocin rate was eventually increased from 3.0 mu/min to 4.0 mu/min at 8:00 PM on 7/5/20.

Review of labor monitoring records and interview with Director #1 on 7/17/20 at 12:18 PM indicated three late fetal heart rate decelerations (decrease in the fetal heartrate below the fetal baseline with time from onset to the point of lowest being >30 seconds) occurred on 7/5/20 from 8:06 PM to 8:12 PM, and a prolonged deceleration at 8:14 PM. Director #1 identified that according to documentation by RN#2, a fluid bolus was administered, P #1 was repositioned and MD #1 was called to review the strips.

RN #2's documentation noted that MD #1 examined P #1 at 8:36 PM and ordered that the Pitocin continue. Director #1 further identified, although RN #2 turned off the Pitocin at 8:38 PM, RN #1 restarted the Pitocin at 9:20 PM, against hospital policy, and increased the Pitocin to 3.0 mU/min at 10:00 PM, despite recurring fetal tachycardia and variable decelerations in fetal heart rate.

Interview with RN #2 on 7/28/20 at 10:00 AM identified that although MD #1 instructed her on 7/4/20 at 8:36 PM to keep the Pitocin on, she waited until MD #1 left the room and turned the Pitocin off at 8:38 PM due to the category II fetal tracing. RN #2 further indicated that she turned the Pitocin back on because contractions were 6 minutes apart, with the goal to get P #1 closer to delivery. RN#2 indicated she should not have restarted the Pitocin based on the fetal tracing. RN #2 noted that when P #1 was fully dilated and started pushing on 7/4/20 at 9:09 PM, the fetal heart rate (FHR) showed prolonged deep decelerations with each push. RN#2 indicated she should have notified the physician, turned off the Pitocin, administered oxygen, and a fluid bolus, however she did not do so.

Labor monitoring strips dated 7/4/20 identified at 11:00 PM P #1 had a temperature of 100.4 degrees, and fetal tachycardia was noted however interventions were not documented by RN #2. The medical record lacked documentation MD#1 was notified of the elevated temperature.

Interview with RN #2 on 7/28/20 at 10:00 AM noted that she should have notified MD #1 about the temperature elevation as this could indicate chorioamnionitis (bacterial infection that could cause serious infection in mother and baby).

The Pitocin administration record identified that the Pitocin was turned off at 1:27 AM on 7/5/20 when the decision for a cesarean section was made by MD#1.

Interview with MD #2 on 7/24/20 at 7:30 AM identified that the decision to continue Pitocin was an error in judgment and added one more stressor to the baby, who was already showing signs of not tolerating the labor.

The facility failed to ensure Pitocin was administered according to facility policy.

The hospital policy entitled Labor Induction or Augmentation identified that in the case of tachysystole, or category 2 or 3 fetal heart rate, to discontinue the Oxytocin, notify the provider, and begin resuscitative measures to include maternal position change, IV fluid bolus and maternal oxygen (O2). The policy further identified that Oxytocin will be administered in the presence of no late decelerations in the past 30 minutes and no more than 2 variable decelerations exceeding 60 seconds and decreasing more than 60 bpm (beats per minute) from baseline in the past 30 minutes.

The hospital policy entitled Electronic Fetal Monitoring identified that category II tracings included tachycardia, minimum variability, and periodic or episodic decelerations.

b. P #3 was admitted for labor augmentation on 7/17/20 at 1:18 AM. The physician order dated 7/17/20 at 5:17 AM directed Oxytocin IV, 30 units in 500 ml of normal saline with a starting dose of 2.0 mU/min. increase by 2.0 mU/min. every 30 minutes not to exceed 20 mU/min.

The medication administration record identified that the Oxytocin was started on 7/17/20 at 5:30 AM as ordered.

Labor monitoring strips, Oxytocin administration records, and nursing summary documentation were reviewed with Director #1 on 8/18/20 at 12:27 PM. The review noted that the Oxytocin was increased by 2.0 mU appropriately at 6:00 AM, 6:30 AM, 7:00 AM and 8:30 AM in accordance with facility policy. The review further identified that the CNM (certified nurse midwife) was at the bedside, viewed the monitoring strips and instructed the Oxytocin be decreased from 10 mU/min. to 4.0 mU/min. due to the contractions were prolonged.

Interview with Director #1 on 8/18/20 at 12:49 PM indicated that per facility policy, the Oxytocin should have been decreased in half to 5.0 mU/min, or an order should have been written by the CNM for a decrease to 4.0 mU/min, when the policy was not followed.

The hospital policy entitled Labor Induction or Augmentation identified that the RN may maintain Oxytocin infusion at current rate, decrease the Oxytocin infusion rate or increase the Oxytocin infusion rate as ordered by the provider to achieve and maintain an adequate labor pattern.

The Hospital Policy entitled Telephone/Verbal Orders for Patient Care identified that verbal orders are not to be given to nursing except under the following circumstances: a patient emergency, the provider is in the process of performing a clinical procedure or a downtime event has been called.


c. P #5 was admitted to the hospital on 7/17/20 at 3:31 PM for induction of labor.

Physician orders dated 7/4/20 at 4:31 PM directed Oxytocin IV 30 units in 500 ml of normal saline with a starting dose of 2.0 mU/min. increase by 1.0 mU/min. every 30 minutes not to exceed 20 mU/min.

The medication administration record identified that the Oxytocin was started on 7/17/20 at 5:31 PM as ordered.

Labor monitoring strips, Oxytocin administration records and nursing summary documentation dated 7/17/20 were reviewed with Director #1 on 8/18/20 at 12:52 PM. The review identified that fetal tracings and maternal contractions, based on facility policy, allowed for the Oxytocin to be increased at 6:00 PM by 1.0 mU/min as ordered however, was not increased until 6:41 PM (delay of one hour instead of 30 minutes). The review further noted that the RN could have increased the Oxytocin rate between 6:41 PM until 9:33 PM and did not change the rate until 9:33 PM (delay of almost 3 hours).

Interview with Director #1 on 8/18/20 at 12:52 PM noted that the medical record lacked documentation as to why the RN had not increased the Oxytocin at 6:00 PM, as ordered. According to fetal tracings and maternal contractions a second increase was indicated at 7:50 PM, however the medical record lacked the reason the Oxytocin was not increased at that time.

The hospital policy entitled Labor Induction or Augmentation identified that the RN may maintain Oxytocin infusion at the current rate, decrease the Oxytocin infusion rate, or increase the Oxytocin infusion rate as ordered by the provider to achieve and maintain an adequate labor pattern.

2. Based on medical record review, review of hospital policies, review of facility documentation, and interviews for one of three patients who required cardiac resuscitation (P #2), the hospital failed to ensure that neonatal resuscitative efforts were initiated in accordance with facility policy. The finding includes:

P #2 was born to P#1 on 7/5/20 at 2:01 AM limp, blue and breathless following a prolonged labor with category II non- reassuring tracings via C-section. P #2's delivery room assessment dated 7/5/20 identified that P #2 was blue or pale with Apgar scores of "0" at 1 minute, and "5" at 10 minutes of life.

P #2's resuscitation record dated 7/5/20 noted that P #2 had no heart rate, chest compressions were initiated at 2:04 AM, and a LMA (laryngeal mask airway) was placed at 2:15 AM (14 minutes of life) following five difficult intubation attempts with an ETT (endotracheal tube) by Physicians Assistant (PA) #1 and Anesthesiologist #1. The resuscitation record further indicated that RN #4, in- house neonatal care unit nurse, and MD #3, on-call Neonatologist, were called at 2:04 AM and 2:11 AM respectively. RN #4 arrived in the operating room (OR) at 2:13 AM (9 minutes after call), PA #1 placed the UVC (umbilical vein catheter) at 2:17 AM and epinephrine was administered at 2:19 AM.

Interview with PA #1 on 7/28/20 at 11:40 AM identified that RN #3 started chest compressions and PA #1 requested that MD #3 and the NICU RN be called to assist. PA #1 further indicated that there seemed to be a delay in RN #2 locating the UVC catheter in the code cart and it was not conveyed to RN #4 to get to the OR right away(took 9 minutes).

Interview with RN #3 on 7/29/20 at 12:15 PM noted that she could have called a Neonatal Intensive Care Unit (NICU) Alert, however it did not cross her mind, and although she had never had a "resuscitation" to this extent, she felt that all of the necessary players were already present in the OR. RN #3 indicated that she instructed RN #5 to call RN #4 to the OR because they needed an extra pair of hands.

Interview with Quality Assurance (QA) Specialist #1 on 7/28/20 at 2:50 PM identified that the bottom drawer of the code cart contained the UVC catheter. The cart drawer was properly marked with the location of the UVC catheter and mock neonatal codes are conducted frequently however in this case the catheter was not promptly obtained.

QA Specialist #1 further indicated that, due to a change in leadership, the NICU Alert policy had not been revised in 2019 as planned, and the policy currently in place required revision.

The facility failed to implement neonatal resuscitation efforts according to facility policy by not initiating a NICU alert.

The Hospital policy entitled NICU Alert dated 3/2017 identified that criteria for initiating a NICU Alert is determined, in part, by Delivery Room staff when a newborn is in a critical situation/life or death event that warrants immediate response from all hospital services without delay. The MD, PA, or RN will activate the NICU alert by dialing "55" notifying the operator of the NICU Alert and location. The operator will activate the NICU team members to include Pediatric PA, Neonatologist, and team members also including the NICU RN.


3. Based on medical record review, review of hospital policies, review of facility documentation, and interviews for one of three couplets (care of the newborn mother and infant) reviewed (P#1/P#2), the hospital failed to ensure that concerns regarding questionable physician patient care were escalated in accordance with facility policy. The finding includes:

P #1 was Gravida 1, Para 0 and was admitted to the hospital on 7/3/20 for labor augmentation and vaginal delivery. Physician orders dated 7/4/20 directed Oxytocin IV (intravenous) 30 units on 500 ml. of normal saline with a starting dose of 1.0 mu/min, increase by 1.0 mu/min every 30 minutes not to exceed 20 mu/min. The Pitocin administration record identified that the Pitocin was started on 7/4/20 at 8:42 AM as ordered and was at a rate of 2,0 mu/min at 4:15 PM.

The Pitocin administration record identified that the Pitocin rate was eventually increased from 3.0 mu/min to 4.0 mu/min at 8:00 PM on 7/5/20. Review of labor monitoring records with Director #1 on 7/17/20 at 12:18 PM identified three late fetal heart rate decelerations on 7/5/20 from 8:06 PM to 8:12 PM, and a prolonged deceleration at 8:14 PM. Director #1 identified that, per RN #2's documentation, a fluid bolus was administered, P #1 was repositioned and MD #1 was called to review the strips.

RN #2's documentation noted that MD #1 examined P #1 at 8:36 PM and ordered that the Pitocin remain on. Director #1 further identified, on 7/17/20 at 12:18 PM, that although RN #2 turned off the Pitocin at 8:38 PM, RN #1 restarted the Pitocin, against hospital policy, at 9:20 PM and increased the Pitocin to a total of 3.0 mu/min at 10:00 PM, despite recurring variable decelerations in fetal heart rate and fetal tachycardia.

Interview with RN #2 on 7/28/20 at 10:00 AM identified that although MD #1 instructed her to keep the Pitocin on at 8:36 PM on 7/4/20, she waited until MD #1 left the room and turned the Pitocin off at 8:38 PM due to the category II fetal tracing. RN #2 noted that she did not feel comfortable turning off the Pitocin until MD #1 walked out of the room.

Interview with Director #1 on 7/17/20 at 12:18 PM noted that she spoke with RN #2 on 7/5/20 and although RN #2 felt that she had voiced her concerns to RN #3 and kept MD #2 informed of the patients status six times during her shift, RN #2 should have further intervened. Director #1 further indicated that the in-house Obstetrics (OB) Hospitalist could have been called for another set of eyes and Director #1 was also available to be called.

The facility failed to intervene when clinical judgment was in question to maintain patient safety.

The hospital policy entitled Chain of Command identified that chain of command may be initiated in conditions that jeopardize patient care and safety such as conflicts concerning plan of care or potentially unsafe orders. The healthcare provider should attempt to resolve the concern by talking directly with the licensed independent practitioner (LIP) involved. If the patient care concern remains unresolved, on off shifts, the administrative house manager/clinical nurse manager should be notified. The healthcare provider has the responsibility to continue notification following Chain of Command as needed.

Subsequent to the event, the hospital submitted an immediate action plan dated 7/15/20 to include immediate staff policy education beginning 7/5/20 and review of the adverse event for possible further action. The facility was found to be compliant with the plan as submitted.

The Hospital submitted a CAP (corrective action plan) dated 8/4/20 to include policy revision nursing and physician education and audit monitoring, The Hospital was found to be compliant with the CAP as submitted during the on- site visits dated 8/18/20 and 8/19/20.