The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

BRYAN MEDICAL CENTER 1600 SOUTH 48TH ST LINCOLN, NE 68506 April 12, 2016
VIOLATION: QAPI Tag No: A0263
Based on interview with administrative staff, record review and review of the provided facility document titled "Immediate Actions and Action Plan", the facility failed to implement preventative actions and mechanisms to ensure the Labor and Delivery nursing staff were competent to provide safe care to their patients following an unexpected fetal demise in which multiple nursing staff failed to competently assess and intervene in accordance with facility policy and physician orders for 1 of 3 sampled patients (Patient 1) who received Oxytocin (a intravenous medication used to stimulate the smooth muscle of the uterus to initiate or aid in the progression of labor). This failure resulted in the determination by the Centers for Medicare and Medicaid Services [CMS] that the Condition of Participation for Quality Assessment and Performance Improvement Program and Nursing Services was not met, and that Immediate Jeopardy [IJ] conditions exist posing a threat of potential serious injury, harm, impairment or death to laboring patients receiving Oxytocin and/or their unborn fetus. Any pregnant patient admitted for childbirth may require induction or augmentation of labor with the use of Oxytocin. Failure to implement immediate effective quality improvement action plans has the potential to affect the care of all patients in the facility. The facility census on Labor and Delivery at the time of entrance on 4/7/2016 was 12. The facility has an average of 279 deliveries per month. The total facility census was 394 at the time of entrance. The administrator was informed of the IJ determination by the State Agency [SA] on 4/12/2016 at 2:15 PM. The facility was unable to provide an acceptable plan of correction prior to survey staff exiting on 4/12/2016. The IJ conditions have remained in effect at the facility since 3/28/2016.

Findings are:

A. Interview with the Clinical Quality Improvement Specialist Registered Nurse (RN-F) done in conjunction with the Nurse Managers for Labor and Delivery and RN-G, the Director of Organizational Quality on 4/11/16 at 1:30 PM revealed the facility did a Root Cause Analysis on 3/29/16 with the staff nurses involved, the attending physician, a Fetal Medicine Physician and a physician-quality designee from the Medical Staff. The analysis found the nursing staff did not correctly assess/interpret the patients EFM (Electronic Fetal Monitor) strips indicating the patient's contractions were occurring too frequently and the baby's heart rate was compromised. Staff did not intervene in accordance with the Oxytocin physician orders to stop the infusion for too frequent contractions and/or when the FHR cannot be determined. Four (4) staff nurses were involved with this patient and none of those nurses intervened appropriately resulting in the fetal death of a full term baby.

B. Review of the document titled "Immediate Actions and Action Plan" under the section titled "Corrective Actions" identified the facility will "review and reinforce" with nursing staff and physicians the adherence to the Oxytocin Induction (initiation of labor)/Augmentation Module. A chart audit was to occur for compliance with Oxytocin Induction/Augmentation orders however, the facility was unable to provide documented evidence showing that audits had begun. The action plan provided did not include when or what would specifically be audited. The facility planned to initiate mandatory quarterly electronic fetal monitor strip review and validation.

C. Interview with the Nursing Manager for Labor and Delivery on 4/11/16 at 1:30 PM revealed the manager was notified on 3/28/16 of the unexpected death of a full term baby during labor. That same morning the manager stated that during shift huddles with staff, the Charge Nurses reviewed the Oxytocin Physician Order Set and the Charge Nurse would be doing an hourly review of all laboring patients Electronic Fetal Monitoring (EFM strips) with all nursing team members. This shift to shift education continued until 4/5/16 with all currently working staff having had the education. The facility had an attendance list as the only documentation of the education, and could not provide evidence that staff were competent to interpret the EFM strips and intervene appropriately. The Manager stated chart audits for compliance with the Oxytocin order set were planned but not started yet. The plan was to do 10 audits per month starting 4/12/16 and would be retrospective to March of 2016. The Manager stated that quarterly EFM strip review would be added to the July 2016 quarterly meeting. All RN's were to complete an Intermediate fetal monitoring course before 12/31/16. [This is a 16 hour course which includes a competency test].
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview with administrative staff, record review and review of the provided facility document titled "Immediate Actions and Action Plan", the facility failed to implement preventative actions and mechanisms to ensure the Labor and Delivery nursing staff were competent to provide safe care to their patients following an unexpected fetal demise in which multiple nursing staff failed to competently assess and intervene in accordance with facility policy and physician orders for 1 of 3 sampled patients (Patient 1) who received Oxytocin (a intravenous medication used to stimulate the smooth muscle of the uterus to initiate or aid in the progression of labor). This failure resulted in the determination by the Centers for Medicare and Medicaid Services [CMS] that the Condition of Participation for Nursing Services was not met, and that Immediate Jeopardy [IJ] conditions exist posing a threat of potential serious injury, harm, impairment or death to laboring patients receiving Oxytocin and/or their unborn fetus. Any pregnant patient admitted for childbirth may require induction or augmentation of labor with the use of Oxytocin. The facility census on Labor and Delivery at the time of entrance on 4/7/2016 was 12. The facility has an average of 279 deliveries per month. The administrator was informed of the IJ determination by the State Agency [SA] on 4/12/2016 at 2:15 PM. The facility was unable to provide an acceptable plan of correction prior to survey staff exiting on 4/12/2016. The IJ conditions have remained in effect at the facility since 3/28/2016.

Findings are:

A. Interview with the Clinical Quality Improvement Specialist Registered Nurse (RN-F) done in conjunction with the Nurse Managers for Labor and Delivery and RN-G, the Director of Organizational Quality on 4/11/16 at 1:30 PM revealed the facility did a Root Cause Analysis on 3/29/16 with the staff nurses involved, the attending physician, a Fetal Medicine Physician and a physician-quality designee from the Medical Staff. The analysis found the nursing staff did not correctly assess/interpret the patients EFM (Electronic Fetal Monitor) strips indicating the patient's contractions were occuring too frequently and the baby's heart rate was compromised. Staff did not intervene in accordance with the Oxytocin physician orders to stop the infusion for too frequent contractions and/or when the FHR cannot be determined. Four (4) staff nurses were involved with this patient and none of those nurses intervened appropriately resulting in the fetal death of a full term baby.

B. Review of the document titled "Immediate Actions and Action Plan" under the section titled "Corrective Actions" identified the facility will "review and reinforce" with nursing staff and physicians the adherence to the Oxytocin Induction (initiation of labor)/Augmentation Module. A chart audit was to occur for compliance with Oxytocin Induction/Augmentation orders however, the facility was unable to provide documented evidence showing that audits had begun. The action plan provided did not include when or what would specifically be audited. The facility planned to initiate mandatory quarterly electronic fetal monitor strip review and validation.

C. Interview with the Nursing Manager for Labor and Delivery on 4/11/16 at 1:30 PM revealed the manager was notified on 3/28/16 of the unexpected death of a full term infant during labor. That same morning the manager stated that during shift huddles with staff, the Charge Nurses reviewed the Oxytocin Physician Order Set and the Charge Nurse would be doing an hourly review of all laboring patients Electronic Fetal Monitoring (EFM strips) with all nursing team members. This shift to shift education continued until 4/5/16 with all currently working staff having had the education. The facility had an attendance list as the only documentation of the education, and could not provide evidence that staff were competent to interpret the EFM strips and intervene appropriately. The Manager stated chart audits for compliance with the Oxytocin order set were planned but not started yet. The plan was to do 10 audits per month starting 4/12/16 and would be retrospective to March of 2016. The Manager stated that quarterly EFM strip review would be added to the July 2016 quarterly meeting. All RN's were to complete an Intermediate fetal monitoring course before 12/31/16. [This is a 16 hour course which includes a competency test].
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview of staff and review of facility records, including the standing order set for "OBGYN Oxytocin [a medication that stimulates the contraction of the smooth muscle of the uterus during labor] Induction/Augmentation Module" and the medical record review of 1 of 3 sampled patients who received Oxytocin during labor [Patient 1]; the facility's nursing staff: 1) failed to accurately evaluate, assess, and the fetal heart rate and the uterine contractions of Patient 1; 2) failed to recognize a complication of the use of Oxytocin and provide interventions, and 3) failed to follow physician's orders for the administration of the Oxytocin which resulted in the fetal death of a full term, normal baby on 3/28/2016.
An interview with the Nursing Manager of Labor and Delivery [L&D] on 4/11/2016 at 1:30 PM confirmed the Electronic Fetal Monitor [EFM] showed a prolonged period of maternal uterine contractions and fetal heart rate abnormalities. The Manager confirmed that nursing staff misinterpreted the EFM information and failed to intervene to protect the life of the unborn child. This failure resulted in the determination by the Centers for Medicare and Medicaid Services [CMS] that the Condition of Participation for Nursing Services was not met, and that Immediate Jeopardy [IJ] conditions exist posing a threat of potential serious injury, harm, impairment or death to laboring patients and/or their unborn fetuses for those patients who were receiving Oxytocin. Any pregnant patient admitted for childbirth may require induction or augmentation of labor with the use of Oxytocin. The facility census on L & D at the time of entrance on 4/7/2016 was 12. The facility has an average of 279 deliveries per month. The administrator was informed of the IJ determination by the State Agency [SA] on 4/12/2016 at 2:15 PM. The facility was unable to provide an acceptable plan of correction prior to exit by the survey team on 4/12/2016. The IJ conditions have remained in effect at the facility since 3/28/2016.

Refer to A-0405.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview of staff, observation, and review of facility records - including the standing order set for "OBGYN Oxytocin [a medication that stimulates the contraction of the smooth muscle of the uterus during labor] Induction/Augmentation Module," and the medical record review of 1 of 3 sampled patients [Patient 1] who received Oxytocin during labor in which the facility's nursing staff: 1) failed to accurately evaluate and assess the fetal heart rate and the uterine contractions of the patient and unborn full-term fetus; 2) failed to recognize a complication of the use of Oxytocin; and 3) failed to follow the physician's orders for the administration of the Oxytocin which resulted in the death of a full term, normal fetus on 3/28/2016. An interview with the Nursing Manager of Labor and Delivery [L&D] on 4/11/2016 at 1:30 PM confirmed the Electronic Fetal Monitor [EFM] showed a prolonged period of maternal uterine contractions and fetal heart rate abnormalities. The Manager confirmed that nursing staff misinterpreted the EFM information and failed to intervene to protect the life of the fetus. This failure resulted in the determination by the Centers for Medicare and Medicaid Services [CMS] that the Condition of Participation for Nursing Services was not met, and that Immediate Jeopardy [IJ] conditions exist posing a threat of potential serious injury, harm, impairment or death to laboring patients and/or their unborn fetus for those patients receiving Oxytocin. Any pregnant patient admitted for childbirth may require induction or augmentation of labor with the use of Oxytocin. The facility census on L & D at the time of entrance on 4/7/2016 was 12. The facility has an average of 279 deliveries per month. The administrator was informed of the IJ determination by the State Agency [SA] on 4/12/2016 at 2:15 PM. The facility was unable to provide an acceptable plan of correction prior to exit by the survey team on 4/12/2016. IJ conditions have remained in effect at the facility since 3/28/2016.

Findings are:

A. Record review of the physician order for Patient 1 on 3/27/2016 at 1:16 PM identifies that nursing staff were to follow a standard order set titled "OBGYN OXYTOCIN INDUCTION/AUGMENTATION MODULE #7865." The Standard Order Set had an effective date of 3/27/2014. The order set stated under the section titled "Vital Signs" that the the patient is to have continuous Electronic Fetal Monitoring [EFM] and stated "Oxytocin is not to be administered if FHR [fetal heart rate] or uterine tracing is not interpretable." Under the section titled "Patient Care" the order set stated "Oxytocin Titration Instructions: Decrease or discontinue Oxytocin for 1) series of single contractions lasting 2 minutes or more, or 2) contractions frequency > 5 in 10 minutes for 2 consecutive periods."

B. A review of Patient 1's Electronic Medical Record [EMR] revealed that the patient was admitted on [DATE] at 1:16 PM. Review of the physician admission note [dated 3/27/2016 at 2:20 PM] identified the patient was 40 weeks and 1 day gestation and this was the patient's first baby. The patient had been having contractions for 30 hours prior to admission. Cervix was dilated to 1 centimeter [cm]. The physician ruptured the membrane [sac of fluid around the baby] and noted a scant amount of fluid. The physician ordered Oxytocin for augmentation of labor [to improve the effectiveness of contractions].

Documentation in the EMR titled "Complete Notes Log"on 3/27/2016 identified the EFM at 3:47 PM showed the fetal heart rate baseline was 135 beats per minute (normal is 110-160 beats per minute). Contractions at 3:48 PM were documented as occurring every 5 to 8 minutes. The physician order for Pitocin [also known as Oxytocin] 2 milliunits/per minute [mu's] IV infusion began at 3:58 PM. Patient 1 received an Epidural [a numbing medication injected into the spinal area for anesthesia during labor and delivery] by an anesthesiologist on 3/27/2016 at 4:12 PM. A Foley catheter to drain urine from the bladder was inserted after the epidural. Oxytocin infusion had been gradually increased to 10 mu's. At 6:51 PM, it was decreased to 8 mu's due to the patient having too many contractions as per the order set. The day shift Registered Nurse [RN-E] assigned to care for Patient 1 called the physician to report the patient status and complaint of headache. Tylenol was ordered by the physician and given to the patient at 6:59 PM. The physician examined the patient at 8:53 PM. According to the physician's progress notes the patient was dilated 4 to 5 cms, and the FHR was 135 to 140. Review of the Complete Notes Log documented the patient had a temperature of 101.8 degrees Fahrenheit [F] with FHR of 180. RN-A called the physician at 10:15 PM to report the temperature and infant's heart rate. The physician ordered another dose of Tylenol and Ancef [antibiotic] 2 grams [gm] to be given IV push to be repeated every 8 hours.

At 11:45 PM the FHR baseline was 180 beats per minute. At 11:55 PM the Oxytocin was documented at 10 mu's/minute. At 12:04 AM the FHR remained at 180 beats per minute. Contractions were documented at 12:05 AM on 3/28/2016 as occurring every 1 to 2.5 minutes and lasting 40 to 60 seconds. Review of the fetal monitoring strips beginning on 3/28/2016 at 12:32 AM show Patient 1 experienced 7 contractions per 10 minute time frames. The fetus's heart rate was consistently noted to be between 150 and 180 beats per minute during that time frame. Oxytocin was documented as infusing at 10 mu's per minute. At 12:45 AM, RN-A noted the FHR was 165 with variable decelerations [decrease of FHR with contractions]. Patient 1 was having contractions every 1 to 2 minutes which lasted 40 to 60 seconds in duration. At 12:46 AM the Oxytocin was noted to be at 8 mu's/minute. Review of the EFM strips revealed at 1:06 AM the FHR dropped from 170 to 100 beats per minute at the peak of contractions. At 1:14 AM the EFM strip revealed the fetal heart rate dropped from 180 to 90 beats per minute after the peak of the contraction. The contractions were occurring at a rate of 6 to 8 every 10 minutes lasting 40 to 60 seconds duration. At 1:45 AM, the FHR was documented at 160 with variable decelerations and continued contractions every 1 to 2 minutes lasting 40 to 60 seconds. At 1:53 AM the charge nurse [RN-B] examined the patient and labor had progressed to 9.5 cms dilatation. The physician was called at 1:55 AM and was given a report on maternal and fetal status. According to the physician progress note [written at 6:30 AM on 3/28/2016]. The physician called in at 1:55 AM and "was given reassurance that everything was going well and pt [patient] was 9 cms."

An interview with the Nursing Manager of Labor and Delivery on 4/11/2016 at 1:30 PM, revealed that variable decelerations were noted on the EFM strips since 12:15 AM and that a decrease of 50 % or prolonged decelerations lasting more than 2 minutes indicated umbilical cord compression. The Manager also stated that the EFM strip showed tachysystole [hyperstimulation of the uterine muscle] that can lead to the fetal circulation being compromised especially if there is insufficient rest between contractions. The manager stated the EFM tracings were misinterpreted by the night nurses in that the decelerations in the baby's heart rate were more frequent and latent. The Manager then stated that when the physician called at 1:55 AM, he was "reassured things were going well due to the misinterpretation of the strip and tachysystole not being assessed correctly."

On 3/28/2016 at 3:42 AM, the Complete Notes Log [nursing notes] documented that RN-A called for assist to the patient's room. The EFM strip showed a drop in the baby's heart rate to 70 after a contraction with slow recovery to 150 followed by a rapid decline again to 60 with the next contraction. At 3:53 AM the patient's heart rate was 150. At 3:45 AM they noted the fetal heart rate was 150 with prolonged decelerations. At 3:55 AM, RN-A attempted to insert a fetal scalp electrode [used to get a more accurate fetal heart rate]. At 3:58 AM, RN-B successfully placed an electrode in the scalp of the fetus. At 4:00 AM, nurses notes stated "indeterminate baseline", unable to pick up the fetal heart beat. Uterine contractions were occurring every 1 to 1.5 minutes lasting 40 to 60 seconds duration. At 4:02 AM, RN-A and RN-B called for more assist. At 4:03 AM, RN-C brought in a Doppler [ultrasound machine] to try to detect the fetal heart rate. The patient's heart rate was 137 to 144 during the time frame of the use of the Doppler, and the Doppler picked up a heart rate of 140 to 150 per minute. At 4:06 AM, RN-D attempted a scalp electrode placement. At 4:15 AM nurses notes revealed "unable to detect fetal baseline, scalp electrode not tracing." The physician was not notified until 4:19 AM, 37 minutes after RN-A first called for assistance. At 4:35 AM the physician arrived and did a bedside ultrasound, which identified at 4:45 AM "Determination by [name of physician] of no fetal heart tones". Fetal death had occurred. At 5:32 AM, an emergency C-section [surgical opening of the womb to deliver the fetus] was performed on Patient 1, and a 7 pound 2 ounce deceased baby boy with no observable abnormalities was delivered.

C. Interview with the Nursing Director of Women's and Children's Health and the Nursing Manager of Labor and Delivery on 4/12/2016 at 11:30 AM, revealed the facility had done an internal investigation of this unexpected fetal death. The review included a review of the record and interviews with the staff involved. They revealed that this review confirmed the nursing staff did not turn off the Oxytocin drip, and it was left to run. The nurses who came in to assist RN-A with the Doppler and to help with the scalp electrode placement should have noticed the Oxytocin was still infusing and that it was contraindicated by the Oxytocin protocol orders. The protocol identifies that staff are to stop the Oxytocin if the fetal heart rate is not interpretable. The protocol also directed nursing staff to decrease or discontinue the Oxytocin when contractions occur more frequently than 5 in 10 minutes for 2 consecutive periods which was not done despite the fact that multiple sections of the EFM strips documented greater than 5 contractions in a 10 minute period had occured.

D. Observations of Labor and Delivery on 4/12/2016 from 12:25 to 12:45 PM revealed the unit had 15 labor and delivery rooms separated by a central nurses station encompassing 2 hallways. They had 2 large flat screen monitors displaying the EFM's with room number for all laboring patients. These monitors were visible on both sides of the unit from the hallway and from all areas of the nurses station. All nursing staff on a shift had the ability to see the monitors displaying the EFM's for laboring patients when they were in or near the nurses station. An audio and visible alarm appeared on the screen display whenever the EFM's were outside the established parameters. The parameters were factory set and alarm occured if the fetal heart rate was greater than 160 for 30 seconds or less than 110 for 15 seconds. Once the heart rate went back into acceptable range, the alarm silenced. The EFM display was also visible on a monitor next to the bedside in each room.

E. Record review of facility policy titled "Fetal Heart Rate Pattern Identification-Labor and Delivery" [effective date 12/22/2015], identified under section 3, "Three-Tier FHR Interpretation System" that a Category III tracing include either:"Absent baseline FHR variability and any of the following: 1) Recurrent late decelerations 2) Recurrent variable decelerations 3) bradycardia [FHR lower than 60]." The Category III tracings are abnormal and are predictive of abnormal fetal acid - base status at the time of observation. Category III FHR tracings require prompt evaluation and care should include, but not limited to: 1) Maternal oxygen 2) Change in maternal position 3) Discontinuation of labor stimulation (Oxytocin is a labor stimulant). There was no documentation in Patient 1's EMR revealing that these interventions had been implemented.