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Tag No.: A0043
Based on interviews, document reviews and medical record review, the hospital's governing body failed to do the following: to establish and implement a clear staffing protocol; to identify, assess and document staff competencies; and to assure patient monitoring equipment was maintained and functioning. The cumulative effect of these issues resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
During the investigation, a draft policy titled "Guidelines for High Risk MD or Neonatologist to Attend Delivery" was presented stating that the policy is being reviewed by the medical staff committee structure. This policy did not include nurse staffing requirements and competencies required to provide safe care to patients.
Nursing leadership is responsible for determining the qualifications and numbers of nursing personnel and other staff necessary to provide safe care for every patient. Patient #1 entered the hospital on 8/14/14 for a scheduled (elective) induction of labor with anticipated delivery of twins at 38 weeks of gestation. Although this was a planned admission of a known twin pregnancy, staffing was not adjusted or planned to safely care for the mother and infants. The facility did not have documented training and competencies for labor and delivery or special care nursery staff.
The physician ordered continuous electronic fetal monitoring. The fetal monitor has the capability to project the fetal heart rate, variability and contractions for one baby per monitor. Two monitors were applied, one to Baby A and one to Baby B. Normal operation includes projection of the bedside information to additional locations including the patient's bedside, operating room and the nurses station. During the labor of Patient #1, the visual component of the fetal heart monitor was not available and staff had to rely on observation of the paper strip and audible heart rates. The facility had no policy and procedure which addressed alternative means (down-time procedures) when the external monitors were not working. No additional staffing to continuously monitor the fetal heart rates and their relation to contractions was provided. The staff relied on audible monitoring of the heart rates for the fetus'.
After the delivery of Baby A at 2337 on 8/14/14, it was discovered at 2355 that the fetal heart monitor was not detecting Baby B's heart rate. The monitor was detecting the mother's heart rate. When a fetal scalp monitor was placed on Baby B, the heart rate was detected in the 60's (normal 140-160 beats per minute). After delivery, Baby B could not be resuscitated and was pronounced dead at 0023 on 8/15/14.
Facility leadership and staff nurses told investigator that they follow staffing standards set by AWHONN. Written policy and procedure did not reflect those national standards.
There is no documentation that the nursing staff has been assessed for competency of skills and knowledge in the Family Birth area to determine safe nursing assignments.
Reference deficiencies written at
Tag A385 - Nursing Services
Tag A386 - Organization of Nursing
Tag A397 - Patient Care Assignments
Tag No.: A0385
Based on interviews, document reviews and medical record review, the hospital's nursing services failed to establish and implement a clear staffing protocol and to identify, assess and document staff competencies. The cumulative effect of these issues resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
Findings include:
On 8/14/14 at 0745, a 28 year old patient who was 38 weeks pregnant was admitted for a scheduled induction of labor. The patient was a gravida 2, para 0 (pregnant twice with no resulting live birth). The patient was known to be carrying twins and the history and physical states she received prenatal care.
The patient was started on intravenous Pitocin at 0919 on 8/14/14 to augment labor and labor progressed through the day without incident. Pitocin (oxytocin) is a uterine stimulant causing uterine contractions to help induce labor for the pregnant woman. The staffing requirement as stated in the Labor Patient Management policy for patients receiving Pitocin were followed based on medical record review.
The fetal heart rate was described at a Category 1 up until 2000 on 8/14/14 and then was changed to Category II. On interview with the Manager of Family Birth Center and verified with the Fetal Monitoring Policy, Category 1 is "normal" and includes moderate variability of the fetus' heart rate, baseline heart rate of 110-160 beats per minute and no late or variable decelerations (temporary drops in the fetal heart rate). The policy on Fetal Monitoring describes Category II as "FHR (fetal heart rate) tracings that do not meet the criteria for Normal or Abnormal". There is no documentation in the medical record as to why the category was changed from Category I to Category II.
At 2050 on 8/14/14, the medical record documentation states the patient was completely dilated (cervix open). The medical record documents that the fetal monitoring strip for Baby A showed "decelerations" and that the physician was notified and came to assess the patient. The decision by the physician was to have Patient #1 continue to labor and have the nursing staff continue to monitor.
At 2140 on 8/14/14, the physician documents that the patient "had a strong urge to push. She began pushing at that point and was bringing the fetus down to +2 station (station refers to how far down the baby's head has descended into the mother's pelvis). We moved to the operating room at approximately 2230". The record does not indicate why the decision was made to move to the operating room. Based on interview with the Manager of FBC and Nurse #2 (labor and delivery specialty nurse), the decision to move to the operation room is made by the physician but is based on the potential of needing to perform a cesarean section (operation to remove the fetus surgically).
At 2230 on 8/14/14, the patient was moved to the operating room per physician order. The documentation states that a second OB physician was "in house" and arrived in the operating room at 2330. The documentation also states that "SCN (special care nurses who care for infants and who have skills beyond neonatal resuscitation) nurses remained at BS (bedside)". On interview with the Manager of Family Birth Center, the unit schedules two SCN nurses for each shift. On the night of 8/14/14, a baby requiring the special care nurse was in the nursery and only one SCN was able to be in attendance for the delivery. Nurse #4, assigned to the delivery, was stated to be a labor and delivery nurse without special care nursery training beyond neonatal resuscitation training (NRP). SCN nurses have the additional training and competencies to care for high risk infants beyond NRP training. No additional SCN nurses were called in to work to assist with the delivery because the staffing guidelines for twin deliveries only calls for an RN, LPN and Scrub Tech.
The physician ordered continuous electronic fetal monitoring. The fetal monitor has the ability to project the fetal strip up on a monitor for the physician to observe. The fetal monitor strip is also monitored at the nursing station. On the night of 8/14/14, the fetal monitoring projection system was not working in the operating room or at the nurses station. On interview with Nurse #2 , s/he states that they can monitor the strip audibly and can hear if there is a change. No downtime procedures (procedures to assure the monitor is continuously observed when the projection system is not working) were able to be produced by the nursing staff to indicate a different monitoring technique can be used in this situation.
The nurse to patient staffing for Patient #1 was 1 to 1. The nurse was required to take care of the patient and could not watch the fetal monitor strip continuously. Based on interview with Nurse #2, s/he stated that only intermittent observation of the fetal heart monitor strip is possible and experienced nurses are able to audibly monitoring the fetal heart rate and can check if abnormalities are heard. This was confirmed by the Family Birth Center Manager on 9/15/14. Physician #1 delivery note in the medical record states "Unfortunately, I was unable to see the display of the fetal heart rate at this point but was only able to see the number of the fetal heart rate as opposed to the entire tracing".
Baby A was vaginally delivered at 2339 on 8/14/14. Apgar scores on Baby A were documented as 4 at birth, 5 one minute after birth and 7 five minutes after birth. Apgar scores measure the appearance, pulse, grimace, activity and respirations immediately after birth with a range of 1 - 10. The baby was taken to the Special Care Nursery by the SCN and the 2nd OB physician.
The documentation states that the "by listening to the heart rate (on the fetal monitor), it sounded like a normal fetal heart rate" on Baby B. Physician #1's delivery note states "during pushing of Fetus A, Fetus B appeared to have a heart rate in the 170s. As pushing progressed, the heart rate came down to the 150s". After the delivery of Baby A, the documentation states that one fetal monitor was removed and the second monitor (monitoring Baby B) was adjusted with a fetal heart rate in the 150s with contraction every 3-4 minutes".
Vital sign documentation on Patient #1 on 08/14/14 is as follows:
Time - HR (heart rate)
2200 - HR was 74
2043 - HR was 80
2100 - HR was 92
2154 - HR was 92
2200 - HR was 85
2230 - no HR was recorded, only temperature and respirations
No further vital signs were recorded on Patient #1
Medical record note at 2355 states that "radial pulse confirmed with pulse ox" (oximetry machine that measure heart rate and oxygen saturation). No documentation of the actual heart rate of Patient #1 was included in the documentation. At 2355, the documentation states that the team discovered the fetal monitor was actually monitoring the mother's heart rate.
A fetal scalp monitor was placed at 2359 to find Baby B's heart rate at 60. Baby B was delivered by vacuum at 0002 on 08/15/14. The SCN and OB physician were called back to the Operating Room, necessitating leaving Baby A without a dedicated SCN. The SCN attending a different infant was required to oversee both his/her current patient and Baby A. A Code Blue was called at 0007 and continued until 0023 on 8/15/14. Physician #1 or Physician #2 were not able to place an endotrachial tube (tube down trachea to support respirations). Physician #4 successfully intubated the baby at 0012. An umbilical intravenous line was attempted throughout the code and was unsuccessful. Emergency medication were delivered through the endotrachial tube. Chest compressions continued throughout the course of the code. The infant time of death was pronounced at 0023 on 8/15/14.
The documentation verifies that a neonatologist was on the phone for consult.
Tag No.: A0386
Based on interview and document review, the hospital failed to provide a staffing plan to provide nursing care for every patient. Failure to determine staffing needs and supply a staffing level to provide nursing care for every patient places patients at risk for not receiving the care they need.
Findings include:
Based on interview with RN #2 and the FBC Manager on 9/12/14 at 1015, the facility staff the Family Birth Unit according to AWHONN (Association of Women's Health, Obstetric and Neonatal Nurses) guidelines. The AWHONN guidelines state that for deliveries with anticipated multiple births, there should be one nurse to care for the mother and one nurse for each baby. If the case is anticipated to be high risk, at least 2 nurses/providers should be assigned to the baby, 1 with complete resuscitation skills including endotrachial intubation and the use of emergency medications.
The facility policy titled Vaginal Delivery states the staffing for vaginal delivery including multiple deliveries is one RN, one LPN and one Scrub Tech. Two SCNs are scheduled for every shift. There is no documentation that states what skills and competencies are required for the labor and delivery nurse and the special care nursery nurse beyond NRP (Neonatal Resuscitation Program).
On the night of 8/14/14, one of the SCNs was assigned to attend a baby previously delivered on the day of 8/14/14. There was only one SCN nurse available for the delivery of Baby A. This same nurse was then requested to leave Baby A and attend to the delivery of Baby B. One labor and delivery nurse was assigned to Patient #1 and one labor and delivery nurse assisted when the patient moved into the operating room. One scrub technician was also present in the case the patient required a cesarean section.
Based on interview, the special care nursery staffing for the night of 8/14/14 was not due to shortage of staff. The core staffing is for two SCN to be scheduled. The staffing was not adjusted with the known delivery of twins and a current baby in the nursery.
Tag No.: A0397
Based on interview and document review, the hospital failed to document the specialized qualification and competence of the nursing staff available. Failure to have access to this documentation may result in an unsafe patient assignment.
Findings include:
On interview with RN #2 on 9/12/14 at 1030, s/he is occasionally assigned as a charge nurse. S/he indicated that there is no documentation available when making patient assignments as to the nurses' skills and abilities. RN #2 stated that they just "knew" and staff the unit accordingly.
On interview with the CNS Educator and FBC Manager on 9/15/14 at 0900, they indicated that there is an orientation skills check list for the nurses newly hired nurses but no documenting exists verifying skills and competencies related to obstetrics and neonatal nursing exists in the employee files. This was verified in 9 out of 10 employee files for nurses in the Family Birth Center area.
Seven out of ten employee files did not contain a current job description outlining the skills and competencies required to work in the Family Birth Unit.