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Based on medical record (MR) review, document review and interview, in two (2) of 13 medical records reviewed, it was determined the medical staff, (a) failed to recognize and respond to significant changes in a patient's condition, (b) failed to provide continuous monitoring during administration of anesthesia consistent with standards of practice, and (c) failed to identify and treat changes in a newborn.
These findings were evident for Patient #1, #2.

This failure may have placed patients at risk for harm.


Findings include:

Review of the Medical Record (MR) for Patient #2 revealed: a thirty year old patient who presented to the Emergency Department (ED) on 9/13/16 at 9:08 PM with a complaint of abdominal pain and vaginal spotting x 1 day. The patient stated she was 8 weeks pregnant. Vital signs at triage were: Temperature 98.2 F (average 98.6 F), Pulse 68 (normal 60-100), Respiration 18 (normal 12 -20) and Blood Pressure (B/P) 118/62 (normal 120/80). Laboratory tests resulted at 10:51 PM revealed Hemoglobin 11.7 (normal range 12.0-16.0), Hematocrit 35.0 (normal range 37 - 47) and Platelets 139K (normal 140K - 400K). Patient was diagnosed with Threatened Abortion and hemorrhage (bleeding), she was treated with intravenous fluids and discharged home 12:25 AM on 9/14/16 in a "stable condition."

The patient returned to the ED on 9/16/16 at 9:13 PM and was seen by the physician at 9:14 PM. The ED physician encounter notes (authored on 9/17/16 at 7:57 AM) identified the following: the patient reported a 2 day history of vaginal bleeding which progressed to dizziness and generalized abdominal pain that day. "Upon arrival the patient was hypotensive (low blood pressure) and minimally responsive and required immediate attention." The physical assessment noted the patient was awake, lethargic (an abnormal state of drowsiness), responsive to voice, pale, sweating and she had lower abdominal tenderness. The pelvic examination noted the patient was pregnant, the opening of the cervix was dilated and there was bleeding. Vital signs at triage were: Temperature 97.9 F, Pulse 80, Respiration 22 and B/P 66/26. Her pain score was 10 (on a scale of 0, to 10) in the pelvis. Laboratory tests reviewed at 9:36 PM revealed Hemoglobin 10.8, Hematocrit 32.2, and Platelets 81K, all of which had decreased from the prior visit. At 11:35 PM, the platelet count further decreased to 76K.

An ultrasound test which was performed at 10:33 PM, revealed there was a 10 week pregnancy with significant bleeding, and the radiologist documented that the findings were discussed with the ED physician at the time of interpretation.
Nursing documentation at 12:12 AM noted the patient's B/P was 68/51, the patient reported increased bleeding at 12:16 AM and she passed the fetus at that time.

The ED physician documented at 9:23 PM on 9/16/16 and on 9/17/16 at 7:57 AM, and noted that he re-evaluated the patient multiple times for subsequent response to continuous treatment and that he was called to evaluate the patient when she passed the fetus. The physician also documented the obstetrician was contacted, the case was discussed and the obstetrician agreed to admit the patient under his care, with a subsequent formal turnover of the case to the obstetric team at 11:41 PM on 9/16/16.
There was no documentation by the ED physician of his multiple examinations and there was no documentation of the patient's response to treatment.

On 9/17/16 at 12:45 AM, Staff D, a 3rd year Family Practice Resident, examined the patient and repeated the documentation of the history of the patient's presentation, vital signs and results of the lab tests. She documented that the patient was in moderate distress with minimal vaginal bleeding. Staff D also noted her treatment plan included: to admit and monitor the patient, continue hydration, Pitocin (medication to increase contractions) and pain medications, follow-up with labs and reassess the patient in the morning for the possibility of performing a D&C (Dilation & Curettage procedure to remove remaining products of the pregnancy). Staff D documented that the patient should be admitted under the obstetrician.

There was no documented evidence of an assessment by the obstetric team and or that the physicians requested the obstetrician to come in and evaluate the patient at this time.

On 9/17/16 at 12:57 AM, Staff F, a 1st year Family Practice Resident, examined the patient and also repeated the documentation written by Staff D. Staff F noted her assessment was limited due to the patient's distress due to severe abdominal pain, that the patient was pale, sweating, breathing rapidly and had dry mucus membranes. The vaginal exam noted there was bleeding and the patient was at high risk because of the active bleeding. Staff F documented the same treatment plan as had been documented by Staff D.

There was no clear documentation of the amount of bleeding and blood loss the patient experienced.
There was no documented care plan to address the ongoing change in the patient's condition.


The policy titled "Responsibilities for Service Call and In-House Consultations," last revised 6/1/16, states: "for the Emergency Room, physicians shall be available immediately for phone consultation and, if medically indicated, will be on site at the hospital within 30 minutes."
There is no documented evidence that this policy was fully implemented while the patient was in the ED.
The policy does not have a provision for immediate consults for the inpatients.

A nurse's note (late entry at 9:43 AM) revealed that at 2:49 AM on 9/17/16, the patient was transferred to the obstetric unit where she was observed to be breathing rapidly at a rate of 28 breaths per minute, she had shallow breathing, was clammy, pale, sweating and her pain score was 10 (on a scale of 0 to 10). The note stated that the residents, Staff D and Staff F, were informed at that time of the patient's current condition.

Nursing notes revealed that at 4:15 AM, approximately 2 hours later, Staff D, the 3rd year Resident notified the obstetrician of the patient's condition but the obstetrician declined to come in to see the patient.
The residents, however, did not document in the medical record that they called the obstetrician and there was no documentation that this situation was escalated.

There was no documented evidence that a physician reassessed the patient from 12:57 AM to 5:00 AM on 9/17/16, nor was there a plan to address the continued decline in the patient's condition..


The policy titled "Maternal Hemorrhage," last reviewed 3/2016, states: it is the facility policy to "promptly recognize and respond to hemorrhage in the obstetrical patient." The policy lists clinical manifestations of maternal hemorrhage to include "no vaginal bleeding to heavy vaginal bleeding, complaints of unusual pain not relieved by usual comfort measures and failed complete delivery of placenta." Symptoms of hemorrhage include shortness of breath, pallor and cool and clammy skin." The policy also states "if hemorrhage is suspected, call provider STAT and determine Stage of hemorrhage ... ... consider transfer to an intensive care unit (ICU), to repeat vital signs and oxygen saturation every five (5) minutes and anticipate surgical intervention."
There was no documented evidence that the medical staff promptly recognized the clinical manifestation of hemorrhage in the obstetric patient referenced in the policy and considered the above interventions.


Nursing note revealed that at on 9/17/16 at 4:35 AM, the obstetrician was called again and he arrived on the unit at 5:05 AM, approximately (8) hours after the patient arrived at the facility. The nurse also documented that a large clot was removed when the obstetrician examined the patient upon his arrival.

Staff C, obstetrician, documented at 5:29 AM that the patient was alert and oriented to person, place, time and situation and that she had moderate bleeding. He also noted the womb was bulky and his determination was the patient had an Incomplete Miscarriage. His plan was to continue Pitocin and for the patient to undergo a Suction Dilation and Curettage (D&C).


Documentation of the patient's operative and post-operative procedure is as follows:
The Anesthesia Record noted at 9/17/16 at 6:21 AM anesthesia was started, and at 6:25 AM, the patient's heart rate was 118 and the B/P was 140/50. There was no identifiable documentation of the heart rate thereafter, although the EKG showed sinus tachycardia (heart rate of more than 100 beats per minute) throughout the procedure. In addition, the B/P at the end of the procedure at 7:00 AM showed there was no diastolic reading (bottom number of the blood pressure reading).
The anesthesiologist documentation at the end of the procedure at 7:12 AM, stated the patient was awake and oriented and there were no complications. There was no documentation of a blood pressure.

Staff C, obstetrician's operative report, noted that "copious products of conception were obtained" during the surgical procedure. He also noted that the "patient was returned to recovery floor in good state." The plan was to monitor urine output and if it is satisfactory and not blood stained, the patient would be discharged.

The OR nurse's addendum note (documented on 9/19/16) revealed at the end of the procedure the anesthesiologist documented, the patient's B/P was low, 64/34, her pulse rate was rapid and her oxygen level was not registering. The OR nurse assessed the patient's hand which was cold, however, the anesthesiologist stated the patient was ready for transfer. The "patient's breathing was rapid and shallow and the finger monitor reading pulse of 243, there was no sat reading (blood oxygen level reading) and the patient was in a sedated state."

An obstetric nurse documented (late on 9/17/16) that the patient was having agonal (gasping) breathing prior to entering the room on the Obstetric Unit at 7:02 AM. A code was called at 7:02 AM when a nurse noted that the patient was pulseless. The patient was pronounced dead at 7:50 AM after resuscitative measures failed.

There was no documentation in the medical record that the anesthesiologist continuously monitored the patient's vital signs during the procedure, and that the patient was transported to the Obstetric Unit at 7:00 AM in a deteriorating condition.

During an interview conducted on 4/7/17 at 2:30 PM, the Chair of Anesthesiology acknowledged the inadequate anesthesia documentation.
Staff E, Patient Safety Officer stated on 4/7/17 at 10:50 AM, that the facility does not have a written policy that directs the anesthesiologists for the monitoring requirements for a patient that is receiving anesthesia.

These findings were discussed with the Chief Medical Officer on 4/7/17 at 4:10 PM.




Review of the Medical Record for Patient #1 identified a newborn baby girl was delivered on 5/8/16 at 2:45 PM.
Four hours later, Staff W, a Resident, documented that a heart murmur was detected on examination. The plan was reassess the finding during the next examination and discuss with a Family Practice Attending.
There was no documentation of a reassessment or a discussion with a Family Practice Attending until approximately 11 hours later.

On 5/9/16 at 6:00 AM, the attending physician, Staff N, examined the baby and documented the presence of a heart murmur and a Patent Ductus Arteriosus (PDA - heart defect) was diagnosed. Staff N noted, "will monitor and discuss with the pediatric provider."
On 5/9/16 at 6:25 AM, the pediatrician, Staff G, examined the newborn and also made the diagnosis of heart murmur consistent with PDA."

A nurse conducted a newborn screening for Congenital Heart Disease (heart defects), at 9:45 AM, which revealed the oxygen level of the right arm (RA) was 88% and the right leg (RL) was 91%. (Newborn range 95 - 99%)
A physician documented that a pediatric cardiologist was consulted, who recommended repeat measurement of oxygen and if less than 95%, the baby should be transferred to hospital that could care for the heart. The physician documented that the repeat oxygen was RA 82-85% and LA was 81%. The physician contacted the neonatologist at the recipient hospital of the mother's choice and transfer was arranged. The pediatrician signed the note for transfer on 5/9/16 at 11:05 AM.
Upon arrival of the recipient facility at 2:30 PM, documentation in the "Transfer Record" noted that the baby's measurement of oxygen was 65% at 2:40 PM, and the recipient facility started the administration of oxygen to the baby at 2 liters per minute.

There was no documented evidence that the facility's medical staff re-evaluated the baby and the oxygen measurement while the baby was awaiting transfer, from 11:00 AM to 2:30 PM on 5/9/16.

During interview on 4/6/17 at 11:00 AM, Staff K, RN Director of the unit stated that the pediatrician did not write an order for vital signs monitoring after seeing the newborn at 11:00 AM that morning.

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Based on medical record review, document review and interview, in 2 (two) of 13 medical records reviewed, it was determined nursing staff (a) did not ensure that a newborn received ongoing assessment and monitoring, and (b) failed to escalate the management of an unstable newborn.
These findings were evident for Patients #1 & #2.

Findings include:

Review of the medical record for Patient #1 revealed, a newborn baby girl, delivered on 5/8/16 at 2:45 PM.

On 5/8/16 at 3:28 PM, Staff W, a physician, ordered vital signs every 30 minutes x 4 until stable then every 12 hours. A review of the medical record revealed that vital signs monitoring was not performed as ordered. Nursing documentation revealed that vital signs were assessed at 3:45 PM, 4:45 PM, 4:58 PM, 6:06 PM, and 8:00 PM.

On 5/9/16 at 6:25 AM, Staff G, pediatrician, examined the baby and noted the baby "has a heart murmur consistent with PDA (Patent Ductus Arteriosus- heart defect)." At 9:45 AM, the nursing staff conducted a newborn screening for Congenital Heart Disease (heart defect) which noted the oxygen level of the right arm (RA) was 88%, and the right leg (RL) was 91%.

A physician documented a phone consultation with a cardiologist at 10:30 AM on 5/9/16. The cardiologist recommended to check the oxygen levels again and if less than 95% the baby should be transferred to a hospital that could care for the heart defect. The repeat oxygen level at 11:00 AM was RA 82-85% and the LA was 81%. The physician contacted the neonatologist at a facility of the mother's choice, transfer was arranged, and the pediatrician signed the transfer note at 11:05 AM on 5/9/16.

There was no documented evidence that the facility provided ongoing assessment and monitoring of the newborn from 11:00 AM to 2:30 PM, while awaiting transfer.

A review of the "Transfer Record" revealed, upon arrival of staff from the recipient facility at 2:30 PM, the baby's oxygen measurement was 65%. At 2:40 PM, the recipient facility documented starting the administration of oxygen to the baby at 2 liters per minute.

During interview on 4/6/17 at 11:00 AM, Staff K, RN, Director of the unit stated that the pediatrician did not write an order for vital signs monitoring after seeing the newborn on 5/9/16.



Review of medical record for Patient #2 revealed, a thirty year old patient who presented to the ED on 9/13/16 at 9:08 PM with a complaint of abdominal pain and vaginal spotting x 1 day. Vital signs upon arrival were: Temperature 98.2 F (average 98.6 F), Pulse 68 (normal 60-100), Respiration 18 (normal 12 - 20) and Blood Pressure (B/P) 118/62 (normal 120/80). Laboratory tests resulted at 10:51 PM revealed Hemoglobin 11.7 (normal range 12.0-16.0), Hematocrit 35.0 (normal range 37 - 47) and Platelets 139K (normal 140K - 400K). The patient was diagnosed with a Threatened Abortion and hemorrhage (bleeding), was treated with intravenous fluids and discharged home 12:25 AM on 9/14/16 in a "stable condition."

The patient returned to the ED on 9/16/16 at 9:13 PM with a complaint of more bleeding x 3 days and worsening abdominal pain. The patient had a low blood pressure and was minimally responsive. Vital signs upon arrival were: Temperature 97.9F, Pulse 80, Respiration 22, B/P 66/26, and she was pale and sweating. Her pain score was 10 (on a scale of 0 to 10) in her pelvis and she was subsequently medicated for pain at 9:57 PM. Laboratory tests at 9:36 PM revealed Hemoglobin 10.8, Hematocrit 32.2, and Platelets 81K, all of which had decreased from the 9/13/16 visit. At 11:35 PM, the platelet count further decreased to 76K. The ultrasound test revealed there was a 10 weeks 2 days pregnancy with bleeding.

Nursing documentation noted the patient's B/P was 68/51 at 12:12 AM on 9/17/16, the patient reported increased bleeding at 12:16 AM and she passed the fetus at that time.

On 9/17/16, at 12:45 AM and at 12:57 AM, the residents assessed the patient. Their plan was to admit and monitor the patient, follow-up with blood tests, continue hydration, Pitocin (medication to increase contractions) and pain medications and reassess the patient in the morning for a possible D&C.

Nursing documentation at 2:26 AM on 9/17/16, revealed a nurse discussed the patient's plan of care with the 3rd year resident prior to the patient's arrival to the obstetric unit, "due to staff feeling uncomfortable with receiving patient in current condition. Encouraged possible heart monitoring for presenting symptoms on arrival to ER, hypotensive (low blood pressure), etc."
A nurse's note (late entry at 9:43 AM) revealed that at 2:49 AM on 9/17/16, the patient was transferred to the obstetric unit where she was observed to be breathing rapidly with respirations of 28 breaths per minute, she had shallow breathing, was clammy, pale, sweating and the pain score remained at 10. The note stated that the residents Staff D and Staff F, were informed at 2:49 AM of the patient's current condition.

There was no documented evidence that the nursing staff escalated their concerns to the nursing supervisor or a provider, regarding the patient's condition and transfer plan.

At 3:07 AM on 9/17/16, nursing documentation revealed the patient's respiratory rate had increased to 36 breaths per minute, then to 38 breaths per minute at 3:50 AM. The respirations were irregular and rapid despite oxygen therapy, and she was pale and clammy.

Nursing notes revealed that at 4:15 AM, the patient "remains tachypneic (rapid breathing), clammy to touch, in severe pain to abdominal/pelvic region. Vaginal bleeding less than moderate." Staff D, the 3rd year Resident notified the "obstetrician to come in and evaluate" the patient at this point but Staff C, the obstetrician declined to come in to see the patient.

There was no documentation in the medical record that a nurse escalated the situation to a nursing supervisor.

Nursing note revealed that at 4:35 AM, the patient was in severe abdominal/pelvic pain and that tissue was noted at the vaginal opening when the patient pushed. Staff C, the obstetrician was called again at this point and he arrived on the unit at 5:05 AM, approximately (8) hours after the patient arrived at the facility. The notes also stated a nurse documented a large clot was removed when Staff C examined the patient upon his arrival.

Nurse's notes revealed that the patient sustained a cardiac arrest at approximately 7:02 AM and was pronounced dead at 7:50 AM that morning when she did not respond to resuscitative measures.

These findings were discussed with the Chief Medical Officer on 4/7/17 at 4:10 PM.