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A complaint investigation was conducted from 01/09/2018 through 01/24/2018 to determine the hospital's compliance with Medicare Conditions of Participation. On January 16, 2018 at 1530, the survey resulted in the identification of an Immediate Jeopardy (IJ) to the health and safety of patients regarding obstetrical (childbirth) care provided from 06/16/2016 through 12/24/2017. Specifically, pursuant to 482.11-Compliance with Federal, State and Local Laws, 482.12-Governing Body, 482.21-Quality Assurance and Performance Improvement Program, 482.22-Medical Staff, 482.23-Nursing Services and 482.25-Pharmaceuical Services, the hospital staff failed to provide safe care to OB patients by not ensuring non-certified OB (Obstetrics) registered nurses were adhering to the NCBON (North Carolina Board of Nursing) rules and statues governing nurses by delivering babies without the attendance of a physician. On 01/16/2018 at 1600, the hospital's leadership staff was notified of the identification of the Immediate Jeopardy.

Findings of the survey revealed from 06/16/2016 through 12/24/2017, 21 of 26 childbirths were nurse deliveries without the attendance of a physician.

Corrective Actions implemented:
10/30/2017 - communication with a NCBON representative regarding the complaint.
10/31/2017 - investigation initiated. Includes discussions with OB Physicians.
11/07/2017 - personnel change related to not practicing within scope of practice for a nurse.
11/13/2017 - education provided to nurses. Education and monitoring were ongoing.

Based on the findings and the corrective actions implemented, the immediate jeopardy was determined to be ongoing.

Based on review of the NCAC (North Carolina Administrative Codes), North Carolina General Statue, Medical Staff By-Laws review, medical record reviews and interviews, the hospital staff failed to ensure nurses, who were delivering babies, were in compliance with State Licensure Law for nursing practice for 21 of 26 patients with nurse deliveries without the attendance of a physician. (Patients #12, 14, 15, 16, 17, 18, 19, 23, 24, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 and 26)

The findings included:

Review on 01/16/2018 of 21 NCAC 36.0224 Registered Nurse components of nursing practice revealed no documentation that non-certified Obstetrical Registered Nurses were permitted to practice medicine for the delivery infants without the attendance of a physician in non-emergent situations.

Review on 01/16/2017 of General Statue Section 90-178.2 revealed, "(1) ...(2) ...(3) Midwifery ...does not include the practice of medicine by a physician licensed to practice medicine when engaged in the practice of medicine as defined by law, the performance of medical acts by a physician assistant or nurse practitioner when performed in accordance with the rules of the North Carolina Medical Board, the practice of nursing by a registered nurse engaged in the practice of nursing as defined by law, or the rendering of childbirth assistance in an emergency situation..."

Review on 01/12/2018 of the hospital's "MEDICAL STAFF BYLAWS" APPENDIX B, "ARTICLE VI - EMERGENCY MEDICAL, SCREENING, TREATMENT, TRANSFER & ON-CALL ROSTER POLICY" approved 01/12/2018 revealed, "6.1 SCREENING, TREATMENT & TRANSFER 6.1(a) Screening (1) ...(2) ...(3) All patients shall be examined by qualified medical personnel. Qualified medical personnel include: (a) ...(b) The following health care professional who are deemed qualified through Human Resources competency evaluations may participate in performing the medical screening examination under the supervision of a qualified physician: (i) Registered Nurses in Labor and Delivery trained in obstetric nursing, where permitted under State law and Hospital policy, who may determine true, false, or no labor but may not make a medical diagnosis..."

1. Closed medical record review on 01/22/2108 revealed on 01/18/2017 at 2149, Patient #12, a 33 year-old OB (obstetrical) patient presented to the hospital's ED (Emergency Department) with complaints of contractions. The patient had an estimated gestational age of 39+ weeks. The patient was escorted to the OB unit, examined and monitored continuously. On 01/19/2017 at At 0550, OB Physician #17 was notified of the patient's status. At 0600 (7 hours and 11 minutes later), the patient was admitted to and monitored while on the obstetrical unit. At 0605 and 0615, OB Physician #17 was notified of the patient's status. At 0625 OB Physician #17 examined the patient. At 1001, the patient had a NSVD (normal spontaneous vaginal delivery) with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #3 (Obstetrical Registered Nurse) was possibly present during the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #3 personnel file was reviewed by SA consultant #2. Review revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

2. Closed medical record review on 01/22/2018 revealed on 12/22/2016 at 2240, Patient #14, a 25 year-old OB patient presented to the OB unit for an OB check-up secondary to contractions. The patient had an estimated gestational age of 40+ weeks. At 2251, OB RN #8 performed the 1st SVE (Sterile Vaginal Examination) and the patient was found to be ready for delivery. OB Physician #17 was notified. At 2305, SROM (Spontaneous Rupture of Membranes) occurred and the patient underwent a 2nd SVE; at which time, the patient was moved to a labor-delivery room. At 2306, patient was crowning and at 2313, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #8 was possibly present during the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #8 personnel file was reviewed by SA consultant #2 which revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

3. Closed medical record review on 01/22/2108 revealed on 11/29/2016 at 0603, Patient #15, a 24 year-old OB patient presented to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 37+ weeks. From 0618 to 1106 (4 hours and 48 minutes), the patient was monitored by the OB nursing staff. At 1107 the patient was admitted to the hospital and at1130, per orders, the patient was moved to a labor and delivery room. Review revealed at1408, OB RN #1 performed the 4th SVE and, a physician was notified while the OB nursing staff continued to monitor the patient. At 1530, a physician was notified to come to delivery. At 1540, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

4. Closed medical record review on 01/23/2018 revealed on 07/22/2016 at 2055, Patient #16, a 34 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. Upon arrival to the OB unit, OB RN #2 performed a vaginal exam and the results were SROM and the patient was crowning. Review revealed the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery.
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Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

5. Closed medical record review on 01/23/2018 revealed on 11/15/2016 a 2140, Patient #17, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. At 2145, OB RN #18 performed a SVE. At 2319 (94 minutes later), OB Physician #16 was notified of the patient's arrival and condition; at which time, orders were received. On 11/16/2016 at 0318, OB Physician #17 notified of 2nd SVE results. At 0410, OB Physician #17 present and performed the 3rd SVE and the patient was admitted to labor and delivery. At 0420, OB Physician #17 performed the 4th SVE. At 0730, OB RN #13, performed the 5th SVE without physician notification of results. At 0845, OB RN #2 performed the 6th SVE without physician notification of results. At 0900, OB RN #2 performed the 7th SVE without physician notification of results. At 0915, OB RN #2 performed the OB 7th SVE and the results were communicated to OB Physician #17. At 0930, OB RN #2 performed the 8th SVE without physician notification of results. At 0945, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery.
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Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

6. Closed medical record review on 01/23/2018 revealed on 11/03/2016 at 0455, Patient #18, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 38+ weeks. At 0515, OB RN #14 performed the 1st SVE and a physician was notified of the results; at which time, admission orders were received. At 0600, OB RN #14 performed the 2nd SVE and a physician was in the room with the patient. At 0630, OB RN performed the 3rd SVE without physician notification of results. At 0650, the patient experienced SROM, a physician was notified and at 0654, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #14 was possibly present during the delivery.
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Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #14 personnel file was reviewed by SA consultant #2 and revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

7. Closed medical record review on 01/23/2018 revealed on 09/23/2016 at 0352, Patient #19, a 29 year-old OB patient 1st presentation to the OB unit for an OB checkup secondary to contraction. The patient had an estimated gestational age of 38+ weeks. At 0615, OB RN #14 performed the 1st SVE without physician notification of results. At 0622, a physician was at the patient bedside, examination performed, the patient was educated on when to come back and the patient was discharged. Review revealed at 1625, the OB patient presented back to the OB unit via EMS (Emergency Medical Service) for possible labor. OB RN #2 performed the 1st SVE and OB Physician #16 was notified. At 1632, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

8. Closed medical record review on 01/23/2018 revealed on 06/16/2016 at 0700, Patient #23, a 42 year-old OB patient 1st presentation to the OB unit for Day 2 of cervical ripening. The patinet had an estimated gestional age of 39+ weeks. At 0829, OB Physician #16 performed the 1st SVE. At 1000, a OB nursing staff performed the 2nd SVE and the results were no change. OB RN #2 discharged the patient to home with the verbal understanding to return if contractions become stronger. Review revealed at 1145, the OB patient presented back to the OB unit with complaints of labor. A SVE was performed and the result was the patient was crowning. OB Physician #16 notified for delivery. The patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not licensed to practice medicine.

9. Closed medical record review on 01/22/2018 revealed on 11/30/2016 at 0500, Patient #24, a 25 year-old OB patient presented to the OB unit for a checkup secondary to contractions. The patient had an estimated gestional age of 40+ weeks. At 0500, OB RN #25 performed the 1st SVE without physician notification of results. At 0530, OB Physician #16 performed the 2nd examination. At 0630, a physician saw and examined the patient and OB RN #14 received labor and delivery admission orders. At 0825, OB Physician #17 performed the 3rd examination. Review revealed at 0925, OB RN #6 performed the 4th SVE without physician notification of results. At 0955/1000, OB RN #6 performed the 5th SVE without physician notification of results. At 1115, OB Physician #17 was notified of the patient's status and orders were received. At 1128, the patient continued to have contractions and OB RN #2 notified OB Physician #17 of the patient's status and requested presence for delivery. At 1140, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RNs #2 and #14 were possibly present during the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RNs #2 and #14 revealed the nurses had nursing licenses and obstetrical nursing educational requirements were met. Review revealed the nurses were not licensed to practice medicine.



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10. Closed medical record review on 01/22/2018 for Patient #1 revealed a 30 year old, presented to the OB (obstetrical) unit via EMS (Emergency Medical Services) on 06/16/2017 at 1901 with a intrauterine pregnancy at 36 weeks, 6 days. Review of the timeline nursing documentation, revealed at 1903, the patient experienced a spontaneous rupture of membranes (SROM) and voiced the urge to push. Review revealed "nursing staff encouraged pt [patient] not to push and to breathe through contractions until MD (Medical Doctor) arrived." Nursing documentation entered at 1905, revealed [Physician #16] was notified of the patient's status. Review revealed at 1908 (OB RN #5), noted "Delivery of a LFC [Live female child] with nursing staff present. ..." Documentation at 1915 by (OB RN #5), revealed "[Physician #16)] arrived to room...."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018, of OB RN #5's personnel file, revealed she has been an RN since June of 2013, and has a BSN (bachelors of science in nursing) degree. RN #5 was hired on 07/01/2013, and started working on the OB unit on 04/24/2017. Review revealed the nurse was not credentialed to deliver babies.

11. Closed medical record review on 01/23/2018 for Patient #2 revealed a 24 year old at 37 weeks, 4 days arrived to the OB unit exam room on 10/11/2017, at 0828 and was admitted at 0858. Documentation in the timeline of events revealed the patient progressed and at 1550 "([OB RN#6]) entered the patient's room to find the fetal heart rate." At 1551, OB RN#6 documented "Remarks: Trouble finding heart rate. Patient stated she felt like something had dropped. Pulled sheet all the way back and baby's head was between her legs. Pt had no idea it was there. [Director of Birthplace] called to room. [Physician #17] notified and on his way." At 1552, ([OB RN #6]) documented "Delivery of baby. Remarks: Moved patients [sic] legs apart and baby slipped out with out [sic] her pushing. Documentation at 1553 revealed "Delivery of placenta, and at 1554, "Remarks: [Physician #17] in room." Review revealed OB RN #6 did not wait on the physician to clamp and cut the cord or deliver the placenta. The physician arrived one minute after the placenta was delivered.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). Staff #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

12. Closed medical record review on 01/22/2018 for Patient #3's a 24 year old with an intrauterine pregnancy at 34 weeks and 2 days, presented to the OB unit exam room from ED registration on 08/20/2018, at 0409. OB RN #2 documented performed an SVE at 0412 and found the patient to be complete with bulging membranes "that ruptured during the exam....fetal head presenting. [Physician #16] called for delivery and enroute...0413: Infant delivered NSD [normal spontaneous delivery] in exam room... 0415: Placenta delivered [sic]." The OB RN also delivered the placenta and gave oxytocin (with no documented physician order) prior to the physician arriving. The Physician #16 arrived 7 minutes after delivery.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

13. Closed medical record review on 01/22/2018 for Patient #4 revealed a 34 year old arrived to the OB unit via EMS. Review revealed at 0612 the patient arrived via EMS with an RN from the ED (Emergency Department), "screaming out in pain. Pt was transferred to LDR(labor and delivery room) bed and examined by [this RN]. Attempted to place EFM [external fetal monitor] and TOCO [an instrument for measuring the force of uterine contractions] but was unable d/t [due to] pt excessively moving in bed. this nurse attempted to calm pt and [Physician #16] was notified of pt arrival to floor stating that he was on his way. RT [Respiratory Therapy] and [name of pediatrician] were also notified to come to delivery. 0616 - Delivery of live female child by this RN. Meconium stained fluid noted." Review revealed the baby was delivered by OB RN #9, four minutes after the patient's arrival to OB unit.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of OB RN #9's personnel file, revealed she has been an RN since July, 2012, and has a two year ADN (Associates Degree in Nursing). Staff #9 was hired on 04/21/2014, and started working on the OB unit on 04/04/2016. Review revealed the nurse was not credentialed to deliver babies.

14. Closed medical record review on 01/23/2018 for Patient #5 revealed a 29 year old at 41 weeks gestation presented to the OB unit exam room on 08/23/2017 at 1030. Review of the nursing timeline documentation by (RN [Staff #4]) on 08/23/2017 at 1030 revealed "Remarks: pt to Exam room from ED registration via ER [Emergency Room] nurse. pt from WC [wheelchair] to stretcher. membranes bulging... [OB RN #3] at bedside. Pt complete and ruptured on exam table. Infant delivered by [Staff #3]. [Physician #16] notified of delivery, states he is in route...LMC (live male child) born at 1020, placenta intact spontaneously at 1027. 20 milliunits of pitocin given IM. Review revealed the baby was delivered by OB RN #3.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of OB RN #3's personnel file, revealed she has been an RN since June, 2015, and has a two year ADN (Associates Degree in Nursing). Staff #3 was hired on 06/23/2003, and started working in L & D on 04/04/2016. Review revealed the nurse was not credentialed to deliver babies.

15. Closed medical record review on 01/23/2017 for Patient #6 closed medical revealed a 27 year old presented to the OB unit exam room from the ED on 08/21/2017 at 1733. [OB RN #11] documentation revealed "Remarks: Pt arrived on unit via w/c from the ER at 0733. She was experiencing a strong contraction at the time. At the end of the contraction I asked her to try to get up and again she said, 'just give me a minute'. Another contraction started immediately and she stated, 'I need to push!' Review revealed, "[Physician #16] was called but it went to voicemail. LFC spontaneously delivered at 0738. [OB RN #1] was then able to reach [Physician #16] and he was on his way."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018, of OB RN #11's personnel file, revealed she has been an RN since 2001and has a two-year ADN degree. RN #11 was hired on 07/23/2002, and started working on the OB unit in 2015. Review revealed the nurse was not credentialed to deliver babies.

16. Closed medical record review on 01/23/2018 for Patient #7 revealed she presented to the OB unit with contractions three to four minutes apart on 09/24/2017 at 1134 with a 41 week, 4 day gestation. Review of the nursing timeline on 09/25/2017 at 1451 revealed, "Remarks: Infant crowning. [Physician #17] notified by [Director of Birthplace]. He is enroute in his car at present. [Director of Birthplace] in to help with delivery. 1453: Delivery of baby. Remarks: Infant delivered NSD by myself." Review revealed the physician arrived one minute after the baby was born.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). OB RN #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

17. Closed medical record review on 01/23/2018 for Patient #8 revealed a 21 year old who presented to the OB unit on 07/26/2017 at 1800 with contractions on day 2 of cervical ripening (labor induction.). Review of timeline documentation revealed the patient was examined by [Physician #17] and orders were received for admission at 1801. Review revealed the patient progressed and [OB RN #8] notified the MD at 2340 of the patient's request for pain medication at which time he stated he was coming in.[Physician #17] arrived to the floor at 0015 and went to the MD call room, instructing the RN to call when ready for him in the delivery room. Review revealed Staff #9 noted at 0032: "Remarks: Updated [name of physician (Staff #17)] of pt status .... Pt stating the urge to push. MD stated to call him when ready for him." Review revealed at 0035, "Remarks: Pt stated she had urge to push. 2 RNS at bedside. Began pushing with patient. 0100: SROM (spontaneous rupture of membranes), delivery of baby. Notified [Physician #17] he was needed at bedside immediately. ... 0101: MD at bedside."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN#8, revealed she has been an RN since 2014, and has a two year ADN (Associates Degree in Nursing). OB RN #8 was hired on 03/02/2015, and started working on the OB unit on 06/18/2016. Review revealed the nurse was not credentialed to deliver babies.

18. Closed medical record review on 01/22/2018 for Patient #9 revealed a 20 year old presented to the OB unit from ED registration on 06/20/2017 at 0400, with complaints of SROM (spontaneous rupture of membranes) at 0300. Upon arrival the patient experienced a SROM and was examined by [Physician Staff #17].The patient was admitted at 0711 with premature rupture of membranes at 39 weeks, 4 days gestation. Review of the nursing timeline documentation revealed the patient was examined by OB RN #6 at 1553. At 1554 OB RN #6 noted, "[Physician Staff #16] called to check on patient status. Updated him that patient was now complete, but no urge to push... To call him when we are ready." Review revealed, "1604: Patient starting to push with contractions, 1635: [Physician Staff #16] called to attend delivery." Review revealed the baby was delivered at 1639 as [Physician #16] walked in the room.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). OB RN #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

19. Closed medical record review on 01/22/2018 for Patient #10 revealed a 24 year old arrived to the OB unit via EMS on 07/04/2017 at 0645 with hemorrhaging. Review of nursing timeline documentation by OB RN #2 revealed at 0900 "She

Based on hospital by-laws, policy and procedure reviews, North Carolina General Statues, NCBON (North Carolina Board of Nursing) scope of practice for nurses, CMS (Center for Medicare and Medicaid Services)-Appendix A review, leadership meeting reviews, delivery ledger review, medical record reviews, personnel file reviews, call schedule reviews, and staff interviews , the hospital leadership failed to provide oversight and have systems in place to ensure staff met the minimum certification requirements by Federal and State law; failed to ensure an effective QAPI (Quality Assurance Performance Improvement) program to investigate, analysis and implement corrective actions for adverse events; failed to have an organized nursing service to ensure the provision of patient care in a safe environment and failed to have an organized pharmaceutical service to ensure the safe and appropriate use of medications.

Findings included:

1. The hospital failed to adhere to all applicable Federal, State and local laws for the health and safety of patients.

~ refer to §482.11 Compliance with Federal, State and Local Laws Condition: Tag A0020

2. The hospital failed to have an organized medical staff providing oversight of the day to day operations to ensure the quality of medical care provided to patients.

~refer to §482.22 Medical Staff Condition: Tag A0338

3. The hospital failed to have an effective, on-going, data-driven quality assessment and performance system for the monitoring, tracking and analysis of provided services which focus was related to improved health outcomes and the prevention and reduction of medical errors.

~ref to §482.21 QAPI Condition: Tag A0263

4. The hospital failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff supervised and evaluated patient care.

~refer to §482.23 Nursing Condition: Tag A0385

5. The hospital failed to have an effective pharmaceutical service providing oversight of day to day operation to ensure the safe administration of all medication products used in the hospital.

~refer to §482.25 Pharmaceutical Services: Tag A0490

Based on contract reviews and staff interviews, the hospital staff failed to ensure all represenatives listed in of 1 of 2 contracts adhered to the terms of the agreement. (Contract #1).

The findings included:

Review on 01/11/2018 of Contract #1 revealed the agreement was established between the [Hospital] and [Obstetrical] Practice group with an effective date of 10/01/2014. Review revealed Obstetrical physicians #16 and #17 were owners of [Obstetrical] Practice group. Review of the terms of the agreement as outlined in the contract revealed the additional requirements included that one physician to be available per shift at all times throughout the year (24 hours per day, 7 days per week, 365 days per year); in that, during schedule call coverage shifts the physician designated for that shift shall remain "exclusively" available to respond to the calls from [Hospital]. Review revealed on 09/30/2014, the President of the [Obstetrical] Practice group and the former CEO of [Hospital] certified and executed the agreement as indicated by their signatures.

Interview on 01/11/2018 at 1305 with CEO and Interim Chief Nurse Officer revealed the hospital was in the mist of a culture change: "Quality, Teamwork, Speak-up" was stated at every board and leadership meeting. As related to the obstetrical contract interview revealed with the contract, there was a contract breach in that while on call, the Obstetrical Physicians were exclusive to the hospital. Interviewee revealed the physicians were allowed to practice in their private practice while assuming call responsibilities because the CEO did not want to pay for on-call pay for a physician to come in and take care of a patient in their service. Interview revealed the CEO assumed responsibility for the contract breach by not having the contract changed.

Interview on 01/23/2018 at 1615 with the Birthplace Director while observing the on-call schedule revealed the OB physicians were just not providing obstetrical medical care service in their private practice and in the hospital but was also providing obstetrical medical care services at the [county] health department.

Based on call schedule reviews, hospital policy and procedure reviews, staff interviews and Centers for Medicare and Medicaid (CMS) Services-Appendix A, Interpretative Guidelines, the hospital failed to have an effective, on-going, data-driven quality assessment and performance system monitoring of provided services which focus was related to improved health outcomes and the prevention and reduction of medical errors.

The findings included:

1. The hospital staff failed to monitor, track and analyze call repsonse times for 2 of 2 contracted obstetrical physicians.

~refer to §482.21(b)(2)(i) QAPI Standard: Tag A0273


2. The hospital staff failed to measure, analyze, and track 21 of 21 nurse deliveries to ensure patient safety per policy.

~refer to §482.21(c)(2) QAPI Standard: TagA0286

Based on medical record reviews, meeting minutes review, call schedule review and staff interviews, the hospital staff failed to monitor and track physicians call response times for 2 of 2 contracted obstetrical physicians (Physicians #16 and #17) for 9 of 21 patients with nurse deliveries without the attendance of a physician. (Patients #12, 14, 15, 16, 17, 18, 19, 23 and 24)

The findings included:

1. Closed medical record review on 01/22/2108 revealed on 01/18/2017 at 2149, Patient #12, a 33 year-old OB (obstetrical) patient presented to the hospital's ED (Emergency Department) with complaints of contractions. The patient had an estimated gestational age of 39+ weeks. The patient was escorted to the OB unit, examined and monitored continuously. On 01/19/2017 at 0550 (8 hours and 1 minute later), OB Physician #17 was notified of the patient's status. At 0600 (8 hours and 11 minutes later), the patient was admitted to and monitored while on the obstetrical unit. At 0605 and 0615, OB Physician #17 was notified of the patient's status. At 0625 (8 hours and 36 minutes later), OB Physician #17 examined the patient. At 1001 (11 hours and 48 minutes later), the patient had a NSVD (normal spontaneous vaginal delivery) with nurse delivery of a viable child without the attendance of a physician.

Review on 01/11/2108 of Nursing Leadership Minutes dated December 19, 2017 revealed the Director of the Birthplace commented "...Continue to have long wait time for doctor. Yesterday waited 3 hours."

Review on 01/23/2018 of the call schedule revealed from 06/2016 to 10/2017, obstetrical physicians #16 and #17 primarily provided rotated obstetrical call and medical staff services to the hospital seven days per week while providing obstetrical medical services to their private practice five days per week, with the exception of holidays and while also providing obstetrical medical services to [County] health department one day per week, primarily on Friday.

Interview on 01/09/2018 with the Physician Recruiter and the Physician/Industry Relations representative revealed the hospital currently had 10-11contracted service agreements and one of the agreement was with the Obstetrical group. Interviewees revealed scheduling was made four weeks ahead of time, sent to the nursing unit via email at end of each month and the Nurse manager/nursing unit responsible for posting. As related to any scheduled changes, a revised schedule would be sent to the nursing unit via (Office Manager/Physician/Physician Group). Interviewees revealed the Obstetrical contract agreement was establish between the [Hospital] and Obstetrical physicians #16 and #17. Although the obstetrical group had a mid-level provider in their group, the mid-level provider was not subject to the call requirements. Interviewees revealed no quality improvement concerns had been reported.

Interview on 01/10/2018 at 0922 with Director of Quality, Risk/Patient Safety revealed the investigation dates of 06/2016 - 10/2017 were obtained from the delivery books from the nurses handwritten documentation which was identified as a concern related to the increase of "precipitous" births. Interviewee revealed there had been a decrease in the number, from five to two, Obstetrical physicians practicing at the hospital. The decrease of Obstetrical physicians was related to relocation and practicing with a different group. As related to obstetrical physicians call response times, interviewee revealed no monitoring had occurred within the last year, reason not provided. Interviewee revealed during the course of the investigation, the CEO (Chief Executive Officer) spoke with the Obstetrical physicians and offered a nurse mid-wife; which was declined. Interviewee revealed Obstetrical physicians were a contracted group that does have a mid-level provider, but the mid-level does not take call. Interviewee revealed Obstetrical physician group was actively recruiting and a new physician would start possibly July 2018.

Interview on 01/10/2018 at 0930 with the Director of the Birthplace revealed the Obstetrical physician call response times were monitored starting in October of 2017 in comparison to medical record(s). The monitoring was primarily due to an increase number of precipitous births that were identified in June 2016. Interviewee revealed the Obstetrical physician call response times were possibly a problem.

Interview on 01/11/2018 at 1105 with OB RN (Obstetrical Registered Nurse) #13 revealed the interviewee provided obstetrical nursing care from 03/2016 to 03/2017. The nurse transferred from the obstetrical unit due to concerns with nursing license secondary to call response times by both Obstetrical physicians and request to perform duties beyond scope of practice, (i.e. educating a patient on a procedure). Interview revealed concerns with Obstetrical medical services provided at the hospital.

Interview on 01/11/2018 at 1142 with The Director of the Birthplace revealed review of the 09/2017 leadership meeting minutes related to OB physician on-call response times - of waiting for 3 hours. Interviewee started crying, State Consultant #1 terminated interview. Interviewee failed to return for interview continuation.

Interview on 01/11/2018 at 1305 with CEO and Interim Chief Nurse Officer revealed the hospital was in the midst of a culture change: "Quality, Teamwork, Speak-up" was stated at every board and leadership meeting. On 11/03/2017, the CEO had a "serious" conservation with the Obstetrical physicians which included call response times, medication orders and joint leadership (Physicians and nurses) and that no nursing staff should not have any concerns related to calling a physician. No call concerns verbalize by any nursing staff with call response times. Interview revealed obstetrical call response times were not monitored.

Interview on 01/11/2018 at 1325 with OB Physician #17 revealed the Obstetrical physician had call requirements in addition to office hours. The office hours were Monday-Thursday 0800-1700 w/ a block of time off from 1200-1300/1330. Interview revealed currently, the contracted Obstetrical Physicians had a lot of patients in the practice and were actively recruiting, but it was a "hard sell." Interview revealed the physician also provided obstetrical medical services at the [County] health department.

Interview on 01/12/2018 at 1010 with Director of Quality, Risk and Patient Safety revealed the interviewee was unaware if OB nurses knew to communicate with ED physicians in an emergency situations and was unaware if qualified evaluator training informs OB nurses to notify ED physician with emergency situations. Interview revealed there were no incident reports with precipitous deliveries but there have should been because they (precipitous deliveries) were not the norm. Interview revealed the interviewee had requested, date unknown, the Director of the Birthplace to complete incident reports with each precipitous birth.

Interview on 01/12/2018 at 1110 with OB RN #27 revealed there were call concerns with Obstetrical Physician #16. Interviewee revealed the physician was and is a good doctor but now, due to the years of service, the physician "needs to retire." As related to nurse deliveries / precipitous deliveries, the interviewee revealed the new nurses may wait until the last minute to call a physician and Obstetrical Physician #16, will wait longer to come in for a patient for the determination of labor. Interview revealed Obstetrical nurses cannot determine labor and concerns were voiced to the Director of the Birthplace which reported the concerns upward.

2. Closed medical record review on 01/22/2018 revealed on 12/22/2016 at 2240, Patient #14, a 25 year-old OB patient presented to the OB unit for an OB check-up secondary to contractions. The patient had an estimated gestational age of 40+ weeks. At 2251 (11 minutes later), OB RN #8 performed the 1st SVE (Sterile Vaginal Examination) and the patient was found to be ready for delivery. OB Physician #17 was notified. At 2305 (25 minutes later), SROM (Spontaneous Rupture of Membranes) occurred and the patient underwent a 2nd SVE; at which time, the patient was moved to a labor-delivery room. At 2306 (26 minutes later), the patient was crowning and at 2313 (33 minutes later), the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician.

Review on 01/11/2108 of Nursing Leadership Minutes dated December 19, 2017 revealed the Director of the Birthplace commented "...Continue to have long wait time for doctor. Yesterday waited 3 hours."

Review on 01/23/2018 of the call schedule revealed from 06/2016 to 10/2017, obstetrical physicians #16 and #17 primarily provided rotated obstetrical call and medical staff services to the hospital seven days per week while providing obstetrical medical services to their private practice five days per week, with the exception of holidays and while also providing obstetrical medical services to [County] health department one day per week, primarily on Friday.

Interview on 01/09/2018 with the Physician Recruiter and the Physician/Industry Relations representative revealed the hospital currently had 10-11contracted service agreements and one of the agreement was with the Obstetrical group. Interviewees revealed scheduling was made four weeks ahead of time, sent to the nursing unit via email at end of each month and the Nurse manager/nursing unit responsible for posting. As related to any scheduled changes, a revised schedule would be sent to the nursing unit via (Office Manager/Physician/Physician Group). Interviewees revealed the Obstetrical contract agreement was establish between the [Hospital] and Obstetrical physicians #16 and #17. Although the obstetrical group had a mid-level provider in their group, the mid-level provider was not subject to the call requirements. Interviewees revealed no quality improvement concerns had been reported.

Interview on 01/10/2018 at 0922 with Director of Quality, Risk/Patient Safety revealed the investigation dates of 06/2016 - 10/2017 were obtained from the delivery books from the nurses handwritten documentation which was identified as a concern related to the increase of "precipitous" births. Interviewee revealed there had been a decrease in the number, from five to two, Obstetrical physicians practicing at the hospital. The decrease of Obstetrical physicians was related to relocation and practicing with a different group. As related to obstetrical physicians call response times, interviewee revealed no monitoring had occurred within the last year, reason not provided. Interviewee revealed during the course of the investigation, the CEO (Chief Executive Officer) spoke with the Obstetrical physicians and offered a nurse mid-wife; which was declined. Interviewee revealed Obstetrical physicians were a contracted group that does have a mid-level provider, but the mid-level does not take call. Interviewee revealed Obstetrical physician group was actively recruiting and a new physician would start possibly July 2018.

Interview on 01/10/2018 at 0930 with the Director of the Birthplace revealed the Obstetrical physician call response times were monitored starting in October of 2017 in comparison to medical record(s). The monitoring was primarily due to an increase number of precipitous births that were identified in June 2016. Interviewee revealed the Obstetrical physician call response times were possibly a problem.

Interview on 01/11/2018 at 1105 with OB RN (Obstetrical Registered Nurse) #13 revealed the interviewee provided obstetrical nursing care from 03/2016 to 03/2017. The nurse transferred from the obstetrical unit due to concerns with nursing license secondary to call response times by both Obstetrical physicians and request to perform duties beyond scope of practice, (i.e. educating a patient on a procedure). Interview revealed concerns with Obstetrical medical services provided at the hospital.

Interview on 01/11/2018 at 1142 with The Director of the Birthplace revealed review of the 09/2017 leadership meeting minutes related to OB physician on-call response times - of waiting for 3 hours. Interviewee started crying, State Consultant #1 terminated interview. Interviewee failed to return for interview continuation.

Interview on 01/11/2018 at 1305 with CEO and Interim Chief Nurse Officer revealed the hospital was in the midst of a culture change: "Quality, Teamwork, Speak-up" was stated at every board and leadership meeting. On 11/03/2017, the CEO had a "serious" conservation with the Obstetrical physicians which included call response times, medication orders and joint leadership (Physicians and nurses) and that no nursing staff should not have any concerns related to calling a physician. No call concerns verbalize by any nursing staff with call response times. Interview revealed obstetrical call response times were not monitored.

Interview on 01/11/2018 at 1325 with OB Physician #17 revealed the Obstetrical physician had call requirements in addition to office hours. The office hours were Monday-Thursday 0800-1700 w/ a block of time off from 1200-1300/1330. Interview revealed currently, the contracted Obstetrical Physicians had a lot of patients in the practice and were actively recruiting, but it was a "hard sell." Interview revealed the physician also provided obstetrical medical services at the [County] health department.

Interview on 01/12/2018 at 1010 with Director of Quality, Risk and Patient Safety revealed the interviewee was unaware if OB nurses knew to communicate with ED physicians in an emergency situations and was unaware if qualified evaluator training informs OB nurses to notify ED physician with emergency situations. Interview revealed there were no incident reports with precipitous deliveries but there have should been because they (precipitous deliveries) were not the norm. Interview revealed the interviewee had requested, date unknown, the Director of the Birthplace to complete incident reports with each precipitous birth.

Interview on 01/12/2018 at 1110 with OB RN #27 revealed there were call concerns with Obstetrical Physician #16. Interviewee revealed the physician was and is a good doctor but now, due to the years of service, the physician "needs to retire." As related to nurse deliveries / precipitous deliveries, the interviewee revealed the new nurses may wait until the last minute to call a physician and Obstetrical Physician #16, will wait longer to come in for a patient for the determination of labor. Interview revealed Obstetrical nurses cannot determine labor and concerns were voiced to the Director of the Birthplace which reported the concerns upward.

3. Closed medical record review on 01/22/2108 revealed on 11/29/2016 at 0603, Patient #15, a 24 year-old OB patient presented to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 37+ weeks. From 0618 to 1106, the patient was monitored by the OB nursing staff. At 1107 (5 hours and 4 minutes), the patient was admitted to the hospital and at 1130 (5 hours and 27 minutes), per orders, the patient was moved to a labor and delivery room. Review revealed at1408 (8 hours and 5 minutes later), OB RN #1 performed the 4th SVE and, a physician was notified while the OB nursing staff continued to monitor the patient. At 1530 (9 hours and 27 minutes later), a physician was notified to come to delivery. At 1540 (9 hours and 37 minutes later), the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Review on 01/11/2108 of Nursing Leadership Minutes dated December 19, 2017 revealed the Director of the Birthplace commented "...Continue to have long wait time for doctor. Yesterday waited 3 hours."

Review on 01/23/2018 of the call schedule revealed from 06/2016 to 10/2017, obstetrical physicians #16 and #17 primarily provided rotated obstetrical call and medical staff services to the hospital seven days per week while providing obstetrical medical services to their private practice five days per week, with the exception of holidays and while also providing obstetrical medical services to [County] health department one day per week, primarily on Friday.

Interview on 01/09/2018 with the Physician Recruiter and the Physician/Industry Relations representative revealed the hospital currently had 10-11contracted service agreements and one of the agreement was with the Obstetrical group. Interviewees revealed scheduling was made four weeks ahead of time, sent to the nursing unit via email at end of each month and the Nurse manager/nursing unit responsible for posting. As related to any scheduled changes, a revised schedule would be sent to the nursing unit via (Office Manager/Physician/Physician Group). Interviewees revealed the Obstetrical contract agreement was establish between the [Hospital] and Obstetrical physicians #16 and #17. Although the obstetrical group had a mid-level provider in their group, the mid-level provider was not subject to the call requirements. Interviewees revealed no quality improvement concerns had been reported.

Interview on 01/10/2018 at 0922 with Director of Quality, Risk/Patient Safety revealed the investigation dates of 06/2016 - 10/2017 were obtained from the delivery books from the nurses handwritten documentation which was identified as a concern related to the increase of "precipitous" births. Interviewee revealed there had been a decrease in the number, from five to two, Obstetrical physicians practicing at the hospital. The decrease of Obstetrical physicians was related to relocation and practicing with a different group. As related to obstetrical physicians call response times, interviewee revealed no monitoring had occurred within the last year, reason not provided. Interviewee revealed during the course of the investigation, the CEO (Chief Executive Officer) spoke with the Obstetrical physicians and offered a nurse mid-wife; which was declined. Interviewee revealed Obstetrical physicians were a contracted group that does have a mid-level provider, but the mid-level does not take call. Interviewee revealed Obstetrical physician group was actively recruiting and a new physician would start possibly July 2018.

Interview on 01/10/2018 at 0930 with the Director of the Birthplace revealed the Obstetrical physician call response times were monitored starting in October of 2017 in comparison to medical record(s). The monitoring was primarily due to an increase number of precipitous births that were identified in June 2016. Interviewee revealed the Obstetrical physician call response times were possibly a problem.

Interview on 01/11/2018 at 1105 with OB RN (Obstetrical Registered Nurse) #13 revealed the interviewee provided obstetrical nursing care from 03/2016 to 03/2017. The nurse transferred from the obstetrical unit due to concerns with nursing license secondary to call response times by both Obstetrical physicians and request to perform duties beyond scope of practice, (i.e. educating a patient on a procedure). Interview revealed concerns with Obstetrical medical services provided at the hospital.

Interview on 01/11/2018 at 1142 with The Director of the Birthplace revealed review of the 09/2017 leadership meeting minutes related to OB physician on-call response times - of waiting for 3 hours. Interviewee started crying, State Consultant #1 terminated interview. Interviewee failed to return for interview continuation.

Interview on 01/11/2018 at 1305 with CEO and Interim Chief Nurse Officer revealed the hospital was in the midst of a culture change: "Quality, Teamwork, Speak-up" was stated at every board and leadership meeting. On 11/03/2017, the CEO had a "serious" conservation with the Obstetrical physicians which included call response times, medication orders and joint leadership (Physicians and nurses) and that no nursing staff should not have any concerns related to calling a physician. No call concerns verbalize by any nursing staff with call response times. Interview revealed obstetrical call response times were not monitored.

Interview on 01/11/2018 at 1325 with OB Physician #17 revealed the Obstetrical physician had call requirements in addition to office hours. The office hours were Monday-Thursday 0800-1700 w/ a block of time off from 1200-1300/1330. Interview revealed currently, the contracted Obstetrical Physicians had a lot of patients in the practice and were actively recruiting, but it was a "hard sell." Interview revealed the physician also provided obstetrical medical services at the [County] health department.

Interview on 01/12/2018 at 1010 with Director of Quality, Risk and Patient Safety revealed the interviewee was unaware if OB nurses knew to communicate with ED physicians in an emergency situations and was unaware if qualified evaluator training informs OB nurses to notify ED physician with emergency situations. Interview revealed there were no incident reports with precipitous deliveries but there have should been because they (precipitous deliveries) were not the norm. Interview revealed the interviewee had requested, date unknown, the Director of the Birthplace to complete incident reports with each precipitous birth.

Interview on 01/12/2018 at 1110 with OB RN #27 revealed there were call concerns with Obstetrical Physician #16. Interviewee revealed the physician was and is a good doctor but now, due to the years of service, the physician "needs to retire." As related to nurse deliveries / precipitous deliveries, the interviewee revealed the new nurses may wait until the last minute to call a physician and Obstetrical Physician #16, will wait longer to come in for a patient for the determination of labor. Interview revealed Obstetrical nurses cannot determine labor and concerns were voiced to the Director of the Birthplace which reported the concerns upward.

4. Closed medical record review on 01/23/2018 revealed on 07/22/2016 at 2055, Patient #16, a 34 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. Upon arrival to the OB unit, OB RN #2 performed a vaginal exam and the results were SROM and the patient was crowning. Review revealed the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery. Review revealed no physician notification nor arrival to the OB unit.

Review on 01/11/2108 of Nursing Leadership Minutes dated December 19, 2017 revealed the Director of the Birthplace commented "...Continue to have long wait time for doctor. Yesterday waited 3 hours."

Review on 01/23/2018 of the call schedule revealed from 06/2016 to 10/2017, obstetrical physicians #16 and #17 primarily provided rotated obstetrical call and medical staff services to the hospital seven days per week while providing obstetrical medical services to their private practice five days per week, with the exception of holidays and while also providing obstetrical medical services to [County] health department one day per week, primarily on Friday.

Interview on 01/09/2018 with the Physician Recruiter and the Physician/Industry Relations representative revealed the hospital currently had 10-11contracted service agreements and one of the agreement was with the Obstetrical group. Interviewees revealed scheduling was made four weeks ahead of time, sent to the nursing unit via email at end of each month and the Nurse manager/nursing unit responsible for posting. As related to any scheduled changes, a revised schedule would be sent to the nursing unit via (Office Manager/Physician/Physician Group). Interviewees revealed the Obstetrical contract agreement was establish between the [Hospital] and Obstetrical physicians #16 and #17. Although the obstetrical group had a mid-level provider in their group, the mid-level provider was not subject to the call requirements. Interviewees revealed no quality improvement concerns had been reported.

Interview on 01/10/2018 at 0922 with Director of Quality, Risk/Patient Safety revealed the investigation dates of 06/2016 - 10/2017 were obtained from the delivery books from the nurses handwritten documentation which was identified as a concern related to the increase of "precipitous" births. Interviewee revealed there had been a decrease in the number, from five to two, Obstetrical physicians practicing at the hospital. The decrease of Obstetrical physicians was related to relocation and practicing with a different group. As related to obstetrical physicians call response times, interviewee revealed no monitoring had occurred within the last year, reason not provided. Interviewee revealed during the course of the investigation, the CEO (Chief Executive Officer) spoke with the Obstetrical physicians and offered a nurse mid-wife; which was declined. Interviewee revealed Obstetrical physicians were a contracted group that does have a mid-level provider, but the mid-level does not take call. Interviewee revealed Obstetrical physician group was actively recruiting and a new physician would start possibly July 2018.

Interview on 01/10/2018 at 0930 with the Director of the Birthplace revealed the Obstetrical physician call response times were monitored starting in October of 2017 in comparison to medical record(s). The monitoring was primarily due to an increase number of precipitous births that were identified in June 2016. Interviewee revealed the Obstetrical physician call response times were possibly a problem.

Interview on 01/11/2018 at 1105 with OB RN (Obstetrical Registered Nurse) #13 revealed the interviewee provided obstetrical nursing care from 03/2016 to 03/2017. The nurse transferred from the obstetrical unit due to concerns with nursing license secondary to call response times by both Obstetrical physicians and request to perform duties beyond scope of practice, (i.e. educating a patient on a procedure). Interview revealed concerns with Obstetrical medical services provided at the hospital.

Interview on 01/11/2018 at 1142 with The Director of the Birthplace revealed review of the 09/2017 leadership meeting minutes related to OB physician on-call response times - of waiting for 3 hours. Interviewee started crying, State Consultant #1 terminated interview. Interviewee failed to return for interview continuation.

Interview on 01/11/2018 at 1305 with CEO and Interim Chief Nurse Officer revealed the hospital was in the midst of a culture change: "Quality, Teamwork, Speak-up" was stated at every board and leadership meeting. On 11/03/2017, the CEO had a "serious" conservation with the Obstetrical physicians which included call response times, medication orders and joint leadership (Physicians and nurses) and that no nursing staff should not have any concerns related to calling a physician. No call concerns verbalize by any nursing staff with call response times. Interview revealed obstetrical call response times were not monitored.

Interview on 01/11/2018 at 1325 with OB Physician #17 revealed the Obstetrical physician had call requirements in addition to office hours. The office hours were Monday-Thursday 0800-1700 w/ a block of time off from 1200-1300/1330. Interview revealed currently, the contracted Obstetrical Physicians had a lot of patients in the practice and were actively recruiting, but it was a "hard sell." Interview revealed the physician also provided obstetrical medical services at the [County] health department.

Interview on 01/12/2018 at 1010 with Director of Quality, Risk and Patient Safety revealed the interviewee was unaware if OB nurses knew to communicate with ED physicians in an emergency situations and was unaware if qualified evaluator training informs OB nurses to notify ED physician with emergency situations. Interview revealed there were no incident reports with precipitous deliveries but there have should been because they (precipitous deliveries) were not the norm. Interview revealed the interviewee had requested, date unknown, the Director of the Birthplace to complete incident reports with each precipitous birth.

Interview on 01/12/2018 at 1110 with OB RN #27 revealed there were call concerns with Obstetrical Physician #16. Interviewee revealed the physician was and is a good doctor but now, due to the years of service, the physician "needs to retire." As related to nurse deliveries / precipitous deliveries, the interviewee revealed the new nurses may wait until the last minute to call a physician and Obstetrical Physician #16, will wait longer to come in for a patient for the determination of labor. Interview revealed Obstetrical nurses cannot determine labor and concerns were voiced to the Director of the Birthplace which reported the concerns upward.

5. Closed medical record review on 01/23/2018 revealed on 11/15/2016 a 2140, Patient #17, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. At 2145 (5 minutes later), OB RN #18 performed a SVE. At 2319 ( one hour and 21 minutes later), OB Physician #16 was notified of the patient's arrival and condition. On 11/16/2016 at 0318 (18 hours and 22 minutes), OB Physician #17 notified of 2nd SVE results. At 0410 (7 hours and 30 minutes later), OB Physician #17 present and performed the 3rd SVE and the patient was admitted to labor and delivery. At 0420 (7 hours and 20 minutes later), OB Physician #17 performed the 4th SVE. At 0730 (10 hours and 50 minutes) , OB RN #13, performed the 5th SVE without physician notification of results. At 0845 (11 hours and 5 minutes), OB RN #2 performed the 6th SVE without physician notification of results. At 0900, OB RN #2 performed the 7th SVE without physician notification of results. At 0915, OB RN #2 performed the OB 7th SVE and the results were communicated to OB Physician #17. At 0930, OB RN #2 performed the 8th SVE without physician notification of results. At 0945, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician.

Review on 01/11/2108 of Nursing Leadership Minutes dated December 19, 2017 revealed the Director of the Birthplace commented "...Continue to have long wait time for doctor. Yesterday waited 3 hours."

Review on 01/23/2018 of the call schedule revealed from 06/2016 to 10/2017, obstetrical physicians #16 and #17 primarily provided rotated obstetrical call and medical staff services to the hospital seven days per week while providing obstetrical medical services to their private practice five days per week, with the exception of holidays and while also providing obstetrical medical services to [County] health department one day per week, primarily on Friday.

Interview on 01/09/2018 with the Physician Recruiter and the Physician/Industry Relations representative revealed the hospital currently had 10-11contracted service agreements and one of the agreement was with the Obstetrical group. Interviewees revealed scheduling was made four weeks ahead of time, sent to the nursing unit via email at end of each month and the Nurse manager/nursing unit responsible for posting. As related to any scheduled changes, a revised schedule would be sent to the nursing unit via (Office Manager/Physician/Physician Group). Interviewees revealed the Obstetrical contract agreement was establish between the [Hospital] and Obstetrical physicians #16 and #17. Although the obstetrical group had a mid-level provider in their group, the mid-level provider was not subject to the call requirements. Interviewees revealed no quality improvement concerns had been reported.

Interview on 01/10/2018 at 0922 with Director of Quality, Risk/Patient Safety revealed the investigation dates of 06/2016 - 10/2017 were obtained from the delivery books from the nurses handwritten documentation which was identified as a concern related to the increase of "precipitous" births. Interviewee revealed there had been a decrease in the number, from five to two, Obstetrical physicians practicing at the hospital. The decrease of Obstetrical physicians was related to relocation and practicing with a different group. As related to obstetrical physicians call response times, interviewee revealed no

Based on policy and procedure review, medical record review, "Delivery Record Book" review, personnel file review and staff interviews, the hospital staff failed to measure, analyze, and track 21 of 21 nurse deliveries to ensure patient safety per policy (Patients #25, 26, 12, 14, 15, 16, 17, 18, 19, 23, 24, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10).

The findings included:

Review on 01/10/2018 of the hospital's policy titled, "Variance Reporting Involving Patients, Visitors, and Employees, H-05-03", revised 06/2015, revealed, " ...PROCEDURE: Employees are encouraged to report all variances utilizing the Variance Report, which includes: near misses, ...hazardous conditions."

1. Closed medical record review on 01/10/2018 for Patient #25 revealed a 23 year-old presented to the Labor and Delivery (L&D) department on 03/20/2017 at 1015 and was admitted at 1214. Review of the H&P dated 03/20/2017 at 1847 by (physician) [Staff #16] revealed, " ...Admit Diagnoses: 1. Intrauterine pregnancy at 39 weeks with active labor. ...Examination was limited by the physician who arrived at the time of patient being post-delivery. ...PLAN: Delivery of placenta since arrival of physician occurred after delivery had just happened. ..." Review of the nursing care timeline provided by hospital Support Staff #1 revealed on 03/20/2017 at 1115 RN [Staff #11] noted, " ...Remarks" Delivery of LFC (Live Female Child) in the bed. [Physician] (Staff #16) called. ...1120 ... [Physician] (Staff #16) to room ...1125 Delivery of placenta..."

Review on 01/12/2018 of the "Delivery Record Book" revealed all entries were handwritten by OB nursing staff. Review revealed the patient's name listed as #19 on the log for the month of March 2017 and marked with an asterisk. Review revealed "precipitous delivery" was handwritten in the "Complications" column.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries. Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery (unable to provide date or time of instruction); however, "there are no incidents reports to date." Interview confirmed nursing staff failed to nurse deliveries per hospital policy.

2. Closed medical record review on 01/16/2018 for Patient #26 revealed a 38 year-old presented to the emergency department (ED) on 08/09/2017 at 1100 via emergency medical services (EMS) with "ruptured membranes", was transported to L&D and admitted at 2300. Review of the History and Physical (H&P) and Delivery Note dated 08/09/2017 at 2331 by (Physician) [Staff #16] revealed, " ...had a rapid labor with the infant's head on the perineum at time of arrival. ... She call EMS at 11 and arrived here presenting with head visible on the perineum. ...She had delivered spontaneously. There was no nuchal cord. The remainder of the infant then delivered. The infant was suctioned. The cord was clamped and cut. Review on 01/16/2018 of the nursing care timeline provided by hospital Support Staff #1 revealed on 08/09/2017 at 2300 RN [Staff #9] noted, " ...40wks & 6/7 d (day) presented to Triage 1 via EMS with c/o (complaints of) contractions since about 2000. ...Pt (Patient) standing bedside [sic], stating that she knows it won't be long before she has this baby. Assistance requested at bedside and for another nurse to notify (Physician) [Staff #16] of pt arrival and status." Review revealed, "SOM (spontaneous rupture of membranes) at 2304 and "Delivery of baby. Remarks: Live male infant delivered by nursing staff. ..."

Review on 01/12/2018 of the "Delivery Record Book" revealed all entries were handwritten by OB nursing staff. Review revealed the patient's name listed as #12 on the log for the month of August 2017 and marked with an asterisk. Review revealed "precipitous" was handwritten in the "Complications" column.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.









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3. Closed medical record review on 01/22/2108 revealed on 01/18/2017 at 2149, Patient #12, a 33 year-old OB (obstetrical) patient presented to the hospital's ED (Emergency Department) with complaints of contractions. The patient had an estimated gestational age of 39+ weeks. The patient was escorted to the OB unit, examined and monitored continuously. On 01/19/2017 at 0550, OB Physician #17 was notified of the patient's status. At 0600, the patient was admitted to and monitored while on the obstetrical unit. At 0605 and 0615, OB Physician #17 was notified of the patient's status. At 0625, OB Physician #17 examined the patient. At 1001, the patient had a NSVD (normal spontaneous vaginal delivery) with nurse delivery of a viable child without the attendance of a physician.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

4. Closed medical record review on 01/22/2018 revealed on 12/22/2016 at 2240, Patient #14, a 25 year-old OB patient presented to the OB unit for an OB check-up secondary to contractions. The patient had an estimated gestational age of 40+ weeks. At 2251, OB RN #8 performed the 1st SVE (Sterile Vaginal Examination) and the patient was found to be ready for delivery. OB Physician #17 was notified. At 2305, SROM (Spontaneous Rupture of Membranes) occurred and the patient underwent a 2nd SVE; at which time, the patient was moved to a labor-delivery room. At 2306, the patient was crowning and at 2313, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

5. Closed medical record review on 01/22/2108 revealed on 11/29/2016 at 0603, Patient #15, a 24 year-old OB patient presented to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 37+ weeks. From 0618 to 1106, the patient was monitored by the OB nursing staff. At 1107, the patient was admitted to the hospital and at 1130, per orders, the patient was moved to a labor and delivery room. Review revealed at1408, OB RN #1 performed the 4th SVE and, a physician was notified while the OB nursing staff continued to monitor the patient. At 1530, a physician was notified to come to delivery. At 1540, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

6. Closed medical record review on 01/23/2018 revealed on 07/22/2016 at 2055, Patient #16, a 34 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. Upon arrival to the OB unit, OB RN #2 performed a vaginal exam and the results were SROM and the patient was crowning. Review revealed the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present during the delivery. Review revealed no physician notification nor arrival to the OB unit.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

7. Closed medical record review on 01/23/2018 revealed on 11/15/2016 a 2140, Patient #17, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. At 2145, OB RN #18 performed a SVE. At 2319, OB Physician #16 was notified of the patient's arrival and condition. On 11/16/2016 at 0318, OB Physician #17 notified of 2nd SVE results. At 0410, OB Physician #17 present and performed the 3rd SVE and the patient was admitted to labor and delivery. At 0420, OB Physician #17 performed the 4th SVE. At 0730, OB RN #13, performed the 5th SVE without physician notification of results. At 0845, OB RN #2 performed the 6th SVE without physician notification of results. At 0900, OB RN #2 performed the 7th SVE without physician notification of results. At 0915, OB RN #2 performed the OB 7th SVE and the results were communicated to OB Physician #17. At 0930, OB RN #2 performed the 8th SVE without physician notification of results. At 0945, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

8. Closed medical record review on 01/23/2018 revealed on 11/03/2016 at 0455, Patient #18, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 38+ weeks. At 0515, OB RN #14 performed the 1st SVE and a physician was notified of the results; at which time, admission orders were received. At 0600, OB RN #14 performed the 2nd SVE and a physician was in the room with the patient. At 0630, OB RN performed the 3rd SVE without physician notification of results. At 0650, the patient experienced SROM, a physician was notified and at 0654, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #14 was possibly present and participated in the delivery of the baby.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

9. Closed medical record review on 01/23/2018 revealed on 09/23/2016 at 0352, Patient #19, a 29 year-old OB patient 1st presentation to the OB unit for an OB checkup secondary to contraction. The patient had an estimated gestational age of 38+ weeks. At 0615, OB RN #14 performed the 1st SVE without physician notification of results. At 0622, a physician was at the patient bedside, examination performed, the patient was educated on when to come back and the patient was discharged. Review revealed at 1625, the OB patient presented back to the OB unit via EMS (Emergency Medical Service) for possible labor. OB RN #2 performed the 1st SVE and OB Physician #16 was notified. At 1632, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

10. Closed medical record review on 01/23/2018 revealed on 06/16/2016 at 0700, Patient #23, a 42 year-old OB patient 1st presentation to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestestional age of 39+ weeks. At 0829, OB Physician #16 performed the 1st SVE. At 1000, an OB nursing staff performed the 2nd SVE and the results were no change. OB RN #2 discharged the patient to home with the verbal understanding to return if contractions become stronger. Review revealed at 1145, the OB patient presented back to the OB unit with complaints of labor. A SVE was performed and the result was the patient was crowning. OB Physician #16 notified for delivery. The patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.

11. Closed medical record review on 01/22/2018 revealed on 11/30/2016 at 0500, Patient #24, a 25 year-old OB patient presented to the OB unit for a checkup secondary to contractions. The patient had an estimated gestional age of 40+ weeks. At 0500, OB RN #25 performed the 1st SVE without physician notification of results. At 0530, OB Physician #16 performed the 2nd examination. At 0630, a physician saw and examined the patient and OB RN #14 received labor and delivery admission orders. At 0825, OB Physician #17 performed the 3rd examination. Review revealed at 0925, OB RN #6 performed the 4th SVE without physician notification of results. At 0955/1000, OB RN #6 performed the 5th SVE without physician notification of results. At 1115, OB Physician #17 was notified of the patient's status and orders were received. At 1128, the patient continued to have contractions and OB RN #2 notified OB Physician #17 of the patient's status and requested presence for delivery. At 1140, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RNs #2, #6 and #14 were possibly present and participated in the delivery of the baby.

Interview on 01/12/2018 at 1010 with the Director of Quality, Risk and Patient Safety revealed precipitous births, nurse deliveries and other unplanned OB procedures should have an incident report. Interview revealed the Birthplace Director was requested to complete incidents reports, date not provided.





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12. Closed medical record review on 01/22/2018 for Patient #1 revealed a 30 year old, presented to the OB (obstetrical) unit via EMS (Emergency Medical Services) on 06/16/2017 at 1901 with a intrauterine pregnancy at 36 weeks, 6 days. Review of the timeline nursing documentation, revealed at 1903, the patient experienced a spontaneous rupture of membranes (SROM) and voiced the urge to push. Review revealed "nursing staff encouraged pt [patient] not to push and to breathe through contractions until MD (Medical Doctor) arrived." Nursing documentation entered at 1905, revealed [Physician #16] was notified of the patient's status. Review revealed at 1908 (OB RN #5), noted "Delivery of a LFC [Live female child] with nursing staff present. ..." Documentation at 1915 by (OB RN #5), revealed "[Physician #16)] arrived to room...."

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

13. Closed medical record review on 01/23/2018 for Patient #2 revealed a 24 year old at 37 weeks, 4 days arrived to the OB unit exam room on 10/11/2017, at 0828 and was admitted at 0858. Documentation in the timeline of events revealed the patient progressed and at 1550 "([OB RN#6]) entered the patient's room to find the fetal heart rate." At 1551, OB RN#6 documented "Remarks: Trouble finding heart rate. Patient stated she felt like something had dropped. Pulled sheet all the way back and baby's head was between her legs. Pt had no idea it was there. [Director of Birthplace] called to room. [Physician #17] notified and on his way." At 1552, ([OB RN #6]) documented "Delivery of baby. Remarks: Moved patients [sic] legs apart and baby slipped out with out [sic] her pushing. Documentation at 1553 revealed "Delivery of placenta, and at 1554, "Remarks: [Physician #17] in room." Review revealed OB RN #6 did not wait on the physician to clamp and cut the cord or deliver the placenta. The physician arrived one minute after the placenta was delivered.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

14. Closed medical record review on 01/22/2018 for Patient #3's a 24 year old with an intrauterine pregnancy at 34 weeks and 2 days, presented to the OB unit exam room from ED registration on 08/20/2018, at 0409. OB RN #2 documented performed an SVE at 0412 and found the patient to be complete with bulging membranes "that ruptured during the exam....fetal head presenting. [Physician #16] called for delivery and enroute...0413: Infant delivered NSD [normal spontaneous delivery] in exam room... 0415: Placenta delivered [sic]." The OB RN also delivered the placenta and gave oxytocin (with no documented physician order) prior to the physician arriving. The Physician #16 arrived 7 minutes after delivery.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

15. Closed medical record review on 01/22/2018 for Patient #4 revealed a 34 year old arrived to the OB unit via EMS. Review revealed at 0612 the patient arrived via EMS with an RN from the ED (Emergency Department), "screaming out in pain. Pt was transferred to LDR(labor and delivery room) bed and examined by [this RN]. Attempted to place EFM [external fetal monitor] and TOCO [an instrument for measuring the force of uterine contractions] but was unable d/t [due to] pt excessively moving in bed. this nurse attempted to calm pt and [Physician #16] was notified of pt arrival to floor stating that he was on his way. RT [Respiratory Therapy] and [name of pediatrician] were also notified to come to delivery. 0616 - Delivery of live female child by this RN. Meconium stained fluid noted." Review revealed the baby was delivered by OB RN #9, four minutes after the patient's arrival to OB unit.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

16. Closed medical record review on 01/23/2018 for Patient #5 revealed a 29 year old at 41 weeks gestation presented to the OB unit exam room on 08/23/2017 at 1030. Review of the nursing timeline documentation by (RN [Staff #4]) on 08/23/2017 at 1030 revealed "Remarks: pt to Exam room from ED registration via ER [Emergency Room] nurse. pt from WC [wheelchair] to stretcher. membranes bulging... [OB RN #3] at bedside. Pt complete and ruptured on exam table. Infant delivered by [Staff #3]. [Physician #16] notified of delivery, states he is in route...LMC (live male child) born at 1020, placenta intact spontaneously at 1027. 20 milliunits of pitocin given IM. Review revealed the baby was delivered by OB RN #3.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

17. Closed medical record review on 01/23/2017 for Patient #6 closed medical revealed a 27 year old presented to the OB unit exam room from the ED on 08/21/2017 at 1733. [OB RN #11] documentation revealed "Remarks: Pt arrived on unit via w/c from the ER at 0733. She was experiencing a strong contraction at the time. At the end of the contraction I asked her to try to get up and again she said, 'just give me a minute'. Another contraction started immediately and she stated, 'I need to push!' Review revealed, "[Physician #16] was called but it went to voicemail. LFC spontaneously delivered at 0738. [OB RN #1] was then able to reach [Physician #16] and he was on his way."

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

18. Closed medical record review on 01/23/2018 for Patient #7 revealed she presented to the OB unit with contractions three to four minutes apart on 09/24/2017 at 1134 with a 41 week, 4 day gestation. Review of the nursing timeline on 09/25/2017 at 1451 revealed, "Remarks: Infant crowning. [Physician #17] notified by [Director of Birthplace]. He is enroute in his car at present. [Director of Birthplace] in to help with delivery. 1453: Delivery of baby. Remarks: Infant delivered NSD by myself." Review revealed the physician arrived one minute after the baby was born.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

19. Closed medical record review on 01/23/2018 for Patient #8 revealed a 21 year old who presented to the OB unit on 07/26/2017 at 1800 with contractions on day 2 of cervical ripening (labor induction.). Review of timeline documentation revealed the patient was examined by [Physician #17] and orders were received for admission at 1801. Review revealed the patient progressed and [OB RN #8] notified the MD at 2340 of the patient's request for pain medication at which time he stated he was coming in.[Physician #17] arrived to the floor at 0015 and went to the MD call room, instructing the RN to call when ready for him in the delivery room. Review revealed Staff #9 noted at 0032: "Remarks: Updated [name of physician (Staff #17)] of pt status .... Pt stating the urge to push. MD stated to call him when ready for him." Review revealed at 0035, "Remarks: Pt stated she had urge to push. 2 RNS at bedside. Began pushing with patient. 0100: SROM (spontaneous rupture of membranes), delivery of baby. Notified [Physician #17] he was needed at bedside immediately. ... 0101: MD at bedside."

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

20. Closed medical record review on 01/22/2018 for Patient #9 revealed a 20 year old presented to the OB unit from ED registration on 06/20/2017 at 0400, with complaints of SROM (spontaneous rupture of membranes) at 0300. Upon arrival the patient experienced a SROM and was examined by [Physician Staff #17].The patient was admitted at 0711 with premature rupture of membranes at 39 weeks, 4 days gestation. Review of the nursing timeline documentation revealed the patient was examined by OB RN #6 at 1553. At 1554 OB RN #6 noted, "[Physician Staff #16] called to check on patient status. Updated him that patient was now complete, but no urge to push... To call him when we are ready." Review revealed, "1604: Patient starting to push with contractions, 1635: [Physician Staff #16] called to attend delivery." Review revealed the baby was delivered at 1639 as [Physician #16] walked in the room.

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is should not be common practice. Interview revealed an incident report should be generated for all "unusual events", including nurse deliveries Interview revealed review of the Incident Report log by hospital administrative staff revealed there was no incident reports in the hospital tracking/monitoring system to date of any nurse deliveries. Interview revealed nursing management staff have been instructed to complete an incident report for each nurse delivery; however, "there are no incidents reports to date." Interview confirmed nursing staff failed to tack nurse deliveries per hospital policy.

21. Closed medical record review on 01/22/2018 for Patient #10 revealed a 24 year old arrived to the OB unit via EMS on 07/04/2017 at 0645 with hemorrhaging. Review of nursing timeline documentation by OB RN #2 revealed at 0900 "She reports feeling fetal movement last night. ...fundus measures 20 wks with measuring tape... [Physician #16] called with report and new orders received. FHT's [fetal heart tones] 149-155 to auscultate." Review revealed an ultrasound was performed at 1000 and "[Physician #16] was given report of no amniotic fluid noted." Review revealed the gestational age by measurement was 21 weeks, 5 days. "MD talked with pt about outcome and plan of care. Pt verbalizes understanding about gestational age/viability and agrees with comfort care for fetus. Admit order received." Review revealed at 1315 the patient complained of increased pressure. Upon exam, the fetus was noted as "Breech presentation [feet first]. [Physician #16] called at 1325 with update and enroute to see patient." Continued review revealed at 1345 "Remarks: 1335 Pt crying and c/o (complained of) increased pressure, pushing with contxs [contractions]. Fetus delivered spontaneously with no signs of life. ...1338: Placenta delivered...[Physician #16] at bedside." Review revealed the fetus was delivered spontaneously at 1335, and the cord was clamped and cut by OB RN #2. The physician arrived at 1338 (three minutes later).

Review on 01/10/2018 of the Variance Reporting log failed to reveal a report submitted related to the nurse delivery.

Interview on 01/12/2018 at 1016 with Staff #20 revealed precipitous deliveries by nurses are considered an "unusual" event and is shou

Based on review of the NCAC (North Carolina Administrative Codes), North Carolina General Statue, Medical Staff By-Laws review, medical record reviews and interviews and Centers for Medicare and Medicaid (CMS) Services-Appendix A, Interpretative Guidelines, the hospital failed to have an organized medical staff providing oversight of the day to day operations to ensure the quality of medical care provided to patients.

The findings included:

1. The hospital staff failed to ensure nurses, who were delivering babies, were credentialed to practice in childbirth for 21 of 26 deliveries without the attendance of a physician.

~refer to §482.22(a)(2) Medical Staff Standard: Tag A0341


2. The hospital staff failed to measure, analyze, and track 21 of 26 nurse deliveries to ensure patient safety per policy.

~refer to §482.22(c)(5) QAPI Standard: TagA0359

Based on review of the NCAC (North Carolina Administrative Codes), North Carolina General Statue, Medical Staff By-Laws review, medical record reviews and interviews, the hospital staff failed to ensure nurses, who were delivering babies, were credentialed for 21 of 26 patients with nurse deliveries without the attendance of a physician. (Patients #12, 14, 15, 16, 17, 18, 19, 23, 24, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 and 26)

The findings included:

Review on 01/16/2018 of 21 NCAC 36.0224 Registered Nurse components of nursing practice revealed no documentation that non-certified Obstetrical Registered Nurses were permitted to practice medicine for the delivery infants without the attendance of a physician in non-emergent situations.

Review on 01/16/2017 of General Statue Section 90-178.2 revealed, "(1) ...(2) ...(3) Midwifery ...does not include the practice of medicine by a physician licensed to practice medicine when engaged in the practice of medicine as defined by law, the performance of medical acts by a physician assistant or nurse practitioner when performed in accordance with the rules of the North Carolina Medical Board, the practice of nursing by a registered nurse engaged in the practice of nursing as defined by law, or the rendering of childbirth assistance in an emergency situation..."

Review on 01/12/2018 of the hospital's "MEDICAL STAFF BYLAWS" APPENDIX B, "ARTICLE VI - EMERGENCY MEDICAL, SCREENING, TREATMENT, TRANSFER & ON-CALL ROSTER POLICY" approved 01/12/2018 revealed, "6.1 SCREENING, TREATMENT & TRANSFER 6.1(a) Screening (1) ...(2) ...(3) All patients shall be examined by qualified medical personnel. Qualified medical personnel include: (a)... (b) The following health care professional who are deemed qualified through Human Resources competency evaluations may participate in performing the medical screening examination under the supervision of a qualified physician: (i) Registered Nurses in Labor and Delivery trained in obstetric nursing, where permitted under State law and Hospital policy, who may determine true, false, or no labor but may not make a medical diagnosis..."

1. Closed medical record review on 01/22/2108 revealed on 01/18/2017 at 2149, Patient #12, a 33 year-old OB (obstetrical) patient presented to the hospital's ED (Emergency Department) with complaints of contractions. The patient had an estimated gestational age of 39-weeks and 4-days. The patient was escorted to the OB unit, examined and monitored continuously. On 01/19/2017 at 0550, OB Physician #17 was notified of the patient's status. At 0600 (7 hours and 11 minutes later), the patient was admitted to and monitored while on the obstetrical unit. At 0605 and 0615, OB Physician #17 was notified of the patient's status. At 0625 OB Physician #17 examined the patient. At 1001, the patient had a NSVD (normal spontaneous vaginal delivery) with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #3 (Obstetrical Registered Nurse) was possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #3 personnel file was reviewed by SA consultant #2. Review revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

2. Closed medical record review on 01/22/2018 revealed on 12/22/2016 at 2240, Patient #14, a 25 year-old OB patient presented to the OB unit for an OB check-up secondary to contractions. The patient had an estimated gestational age of 40-weeks. At 2251, OB RN #8 performed the 1st SVE (Sterile Vaginal Examination) and the patient was found to be ready for delivery. OB Physician #17 was notified. At 2305, SROM (Spontaneous Rupture of Membranes) occurred and the patient underwent a 2nd SVE; at which time, the patient was moved to a labor-delivery room. At 2306, patient was crowning and at 2313, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #8 was possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #8 personnel file was reviewed by SA consultant #2 which revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

3. Closed medical record review on 01/22/2108 revealed on 11/29/2016 at 0603, Patient #15, a 24 year-old OB patient presented to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 37-weeks. From 0618 to 1106 (4 hours and 48 minutes), the patient was monitored by the OB nursing staff. At 1107 the patient was admitted to the hospital and at1130, per orders, the patient was moved to a labor and delivery room. Review revealed at1408, OB RN #1 performed the 4th SVE and, a physician was notified while the OB nursing staff continued to monitor the patient. At 1530, a physician was notified to come to delivery. At 1540, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

4. Closed medical record review on 01/23/2018 revealed on 07/22/2016 at 2055, Patient #16, a 34 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39 weeks. Upon arrival to the OB unit, OB RN #2 performed a vaginal exam and the results were SROM and the patient was crowning. Review revealed the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

5. Closed medical record review on 01/23/2018 revealed on 11/15/2016 a 2140, Patient #17, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39 weeks. At 2145, OB RN #18 performed a SVE. At 2319 (94 minutes later), OB Physician #16 was notified of the patient's arrival and condition; at which time, orders were received. On 11/16/2016 at 0318, OB Physician #17 notified of 2nd SVE results. At 0410, OB Physician #17 present and performed the 3rd SVE and the patient was admitted to labor and delivery. At 0420, OB Physician #17 performed the 4th SVE. At 0730, OB RN #13, performed the 5th SVE without physician notification of results. At 0845, OB RN #2 performed the 6th SVE without physician notification of results. At 0900, OB RN #2 performed the 7th SVE without physician notification of results. At 0915, OB RN #2 performed the OB 7th SVE and the results were communicated to OB Physician #17. At 0930, OB RN #2 performed the 8th SVE without physician notification of results. At 0945, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.
.
Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

6. Closed medical record review on 01/23/2018 revealed on 11/03/2016 at 0455, Patient #18, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 38 weeks. At 0515, OB RN #14 performed the 1st SVE and a physician was notified of the results; at which time, admission orders were received. At 0600, OB RN #14 performed the 2nd SVE and a physician was in the room with the patient. At 0630, OB RN performed the 3rd SVE without physician notification of results. At 0650, the patient experienced SROM, a physician was notified and at 0654, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #14 was possibly present and participated in the delivery of the baby

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #14 personnel file was reviewed by SA consultant #2 and revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

7. Closed medical record review on 01/23/2018 revealed on 09/23/2016 at 0352, Patient #19, a 29 year-old OB patient 1st presentation to the OB unit for an OB checkup secondary to contraction. At 0615, OB RN #14 performed the 1st SVE without physician notification of results. At 0622, a physician was at the patient bedside, examination performed, the patient was educated on when to come back and the patient was discharged. Review revealed at 1625, the OB patient presented back to the OB unit via EMS (Emergency Medical Service) for possible labor. OB RN #2 performed the 1st SVE and OB Physician #16 was notified. At 1632, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

8. Closed medical record review on 01/23/2018 revealed on 06/16/2016 at 0700, Patient #23, a 42 year-old OB patient 1st presentation to the OB unit for Day 2 of cervical ripening. At 0829, OB Physician #16 performed the 1st SVE. At 1000, an OB nursing staff performed the 2nd SVE and the results were no change. OB RN #2 discharged the patient to home with the verbal understanding to return if contractions become stronger. Review revealed at 1145, the OB patient presented back to the OB unit with complaints of labor. A SVE was performed and the result was the patient was crowning. OB Physician #16 notified for delivery. The patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

9. Closed medical record review on 01/22/2018 revealed on 11/30/2016 at 0500, Patient #24, a 25 year-old OB patient presented to the OB unit for a checkup secondary to contractions. At 0500, OB RN #25 performed the 1st SVE without physician notification of results. At 0530, OB Physician #16 performed the 2nd examination. At 0630, a physician saw and examined the patient and OB RN #14 received labor and delivery admission orders. At 0825, OB Physician #17 performed the 3rd examination. Review revealed at 0925, OB RN #6 performed the 4th SVE without physician notification of results. At 0955/1000, OB RN #6 performed the 5th SVE without physician notification of results. At 1115, OB Physician #17 was notified of the patient's status and orders were received. At 1128, the patient continued to have contractions and OB RN #2 notified OB Physician #17 of the patient's status and requested presence for delivery. At 1140, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RNs #2, #6 and #14 were possibly present and participated in the delivery of the baby.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RNs #2 and #14 revealed the nurses had nursing licenses and obstetrical nursing educational requirements were met. Review revealed the nurses were not credentialed to deliver babies.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #6 personnel file was reviewed by SA consultant #2 and revealed nursing licensure and obstetrical educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.


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10. Closed medical record review on 01/22/2018 for Patient #1 revealed a 30 year old, presented to the OB (obstetrical) unit via EMS (Emergency Medical Services) on 06/16/2017 at 1901 with a intrauterine pregnancy at 36 weeks, 6 days. Review of the timeline nursing documentation, revealed at 1903, the patient experienced a spontaneous rupture of membranes (SROM) and voiced the urge to push. Review revealed "nursing staff encouraged pt [patient] not to push and to breathe through contractions until MD (Medical Doctor) arrived." Nursing documentation entered at 1905, revealed [Physician #16] was notified of the patient's status. Review revealed at 1908 (OB RN #5), noted "Delivery of a LFC [Live female child] with nursing staff present. ..." Documentation at 1915 by (OB RN #5), revealed "[Physician #16)] arrived to room...."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018, of OB RN #5's personnel file, revealed she has been an RN since June of 2013, and has a BSN (bachelors of science in nursing) degree. RN #5 was hired on 07/01/2013, and started working on the OB unit on 04/24/2017. Review revealed the nurse was not credentialed to deliver babies.

11. Closed medical record review on 01/23/2018 for Patient #2 revealed a 24 year old at 37 weeks, 4 days arrived to the OB unit exam room on 10/11/2017, at 0828 and was admitted at 0858. Documentation in the timeline of events revealed the patient progressed and at 1550 "([OB RN#6]) entered the patient's room to find the fetal heart rate." At 1551, OB RN#6 documented "Remarks: Trouble finding heart rate. Patient stated she felt like something had dropped. Pulled sheet all the way back and baby's head was between her legs. Pt had no idea it was there. [Director of Birthplace] called to room. [Physician #17] notified and on his way." At 1552, ([OB RN #6]) documented "Delivery of baby. Remarks: Moved patients [sic] legs apart and baby slipped out with out [sic] her pushing. Documentation at 1553 revealed "Delivery of placenta, and at 1554, "Remarks: [Physician #17] in room." Review revealed OB RN #6 did not wait on the physician to clamp and cut the cord or deliver the placenta. The physician arrived one minute after the placenta was delivered.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). Staff #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

12. Closed medical record review on 01/22/2018 for Patient #3's a 24 year old with an intrauterine pregnancy at 34 weeks and 2 days, presented to the OB unit exam room from ED registration on 08/20/2018, at 0409. OB RN #2 documented performed an SVE at 0412 and found the patient to be complete with bulging membranes "that ruptured during the exam....fetal head presenting. [Physician #16] called for delivery and enroute...0413: Infant delivered NSD [normal spontaneous delivery] in exam room... 0415: Placenta delivered [sic]." The OB RN also delivered the placenta and gave oxytocin (with no documented physician order) prior to the physician arriving. The Physician #16 arrived 7 minutes after delivery.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

13. Closed medical record review on 01/22/2018 for Patient #4 revealed a 34 year old arrived to the OB unit via EMS. Review revealed at 0612 the patient arrived via EMS with an RN from the ED (Emergency Department), "screaming out in pain. Pt was transferred to LDR(labor and delivery room) bed and examined by [this RN]. Attempted to place EFM [external fetal monitor] and TOCO [an instrument for measuring the force of uterine contractions] but was unable d/t [due to] pt excessively moving in bed. this nurse attempted to calm pt and [Physician #16] was notified of pt arrival to floor stating that he was on his way. RT [Respiratory Therapy] and [name of pediatrician] were also notified to come to delivery. 0616 - Delivery of live female child by this RN. Meconium stained fluid noted." Review revealed the baby was delivered by OB RN #9, four minutes after the patient's arrival to OB unit.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of OB RN #9's personnel file, revealed she has been an RN since July, 2012, and has a two year ADN (Associates Degree in Nursing). Staff #9 was hired on 04/21/2014, and started working on the OB unit on 04/04/2016. Review revealed the nurse was not credentialed to deliver babies.

14. Closed medical record review on 01/23/2018 for Patient #5 revealed a 29 year old at 41 weeks gestation presented to the OB unit exam room on 08/23/2017 at 1030. Review of the nursing timeline documentation by (RN [Staff #4]) on 08/23/2017 at 1030 revealed "Remarks: pt to Exam room from ED registration via ER [Emergency Room] nurse. pt from WC [wheelchair] to stretcher. membranes bulging... [OB RN #3] at bedside. Pt complete and ruptured on exam table. Infant delivered by [Staff #3]. [Physician #16] notified of delivery, states he is in route...LMC (live male child) born at 1020, placenta intact spontaneously at 1027. 20 milliunits of pitocin given IM. Review revealed the baby was delivered by OB RN #3.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of OB RN #3's personnel file, revealed she has been an RN since June, 2015, and has a two year ADN (Associates Degree in Nursing). Staff #3 was hired on 06/23/2003, and started working in L & D on 04/04/2016. Review revealed the nurse was not credentialed to deliver babies.

15. Closed medical record review on 01/23/2017 for Patient #6 closed medical revealed a 27 year old presented to the OB unit exam room from the ED on 08/21/2017 at 1733. [OB RN #11] documentation revealed "Remarks: Pt arrived on unit via w/c from the ER at 0733. She was experiencing a strong contraction at the time. At the end of the contraction I asked her to try to get up and again she said, 'just give me a minute'. Another contraction started immediately and she stated, 'I need to push!' Review revealed, "[Physician #16] was called but it went to voicemail. LFC spontaneously delivered at 0738. [OB RN #1] was then able to reach [Physician #16] and he was on his way."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018, of OB RN #11's personnel file, revealed she has been an RN since 2001and has a two-year ADN degree. RN #11 was hired on 07/23/2002, and started working on the OB unit in 2015. Review revealed the nurse was not credentialed to deliver babies.

16. Closed medical record review on 01/23/2018 for Patient #7 revealed she presented to the OB unit with contractions three to four minutes apart on 09/24/2017 at 1134 with a 41 week, 4 day gestation. Review of the nursing timeline on 09/25/2017 at 1451 revealed, "Remarks: Infant crowning. [Physician #17] notified by [Director of Birthplace]. He is enroute in his car at present. [Director of Birthplace] in to help with delivery. 1453: Delivery of baby. Remarks: Infant delivered NSD by myself." Review revealed the physician arrived one minute after the baby was born.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). OB RN #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

17. Closed medical record review on 01/23/2018 for Patient #8 revealed a 21 year old who presented to the OB unit on 07/26/2017 at 1800 with contractions on day 2 of cervical ripening (labor induction.). Review of timeline documentation revealed the patient was examined by [Physician #17] and orders were received for admission at 1801. Review revealed the patient progressed and [OB RN #8] notified the MD at 2340 of the patient's request for pain medication at which time he stated he was coming in.[Physician #17] arrived to the floor at 0015 and went to the MD call room, instructing the RN to call when ready for him in the delivery room. Review revealed Staff #9 noted at 0032: "Remarks: Updated [name of physician (Staff #17)] of pt status .... Pt stating the urge to push. MD stated to call him when ready for him." Review revealed at 0035, "Remarks: Pt stated she had urge to push. 2 RNS at bedside. Began pushing with patient. 0100: SROM (spontaneous rupture of membranes), delivery of baby. Notified [Physician #17] he was needed at bedside immediately. ... 0101: MD at bedside."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN#8, revealed she has been an RN since 2014, and has a two year ADN (Associates Degree in Nursing). OB RN #8 was hired on 03/02/2015, and started working on the OB unit on 06/18/2016. Review revealed the nurse was not credentialed to deliver babies.

18. Closed medical record review on 01/22/2018 for Patient #9 revealed a 20 year old presented to the OB unit from ED registration on 06/20/2017 at 0400, with complaints of SROM (spontaneous rupture of membranes) at 0300. Upon arrival the patient experienced a SROM and was examined by [Physician Staff #17].The patient was admitted at 0711 with premature rupture of membranes at 39 weeks, 4 days gestation. Review of the nursing timeline documentation revealed the patient was examined by OB RN #6 at 1553. At 1554 OB RN #6 noted, "[Physician Staff #16] called to check on patient status. Updated him that patient was now complete, but no urge to push... To call him when we are ready." Review revealed, "1604: Patient starting to push with contractions, 1635: [Physician Staff #16] called to attend delivery." Review revealed the baby was delivered at 1639 as [Physician #16] walked in the room.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). OB RN #6 was hired on 01/27/1997,

Based on review of the NCAC (North Carolina Administrative Codes), North Carolina General Statue, Medical Staff By-Laws review, policy and procedure reviews, medical record reviews and interviews, the hospital failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff supervised and evaluated patient care.

The findings included:

1. The hospital staff failed to ensure nurse, who were delivering babies were in compliance with State Licensure Law for nursing practice for 21 of 26 patient with nurse deliveries without the attendance of a physician.

~refer to §482.23(b)(3) Nursing Service Standard: Tag A0394


2. The hospital nursing staff failed to obtain a physician's order prior to discharge for 5 of 25 patients.

~refer to §482.23(b)(4) Nursing Service Standard: Tag A0396

Based on review of the NCAC (North Carolina Administrative Codes), North Carolina General Statue, Medical Staff By-Laws review, medical record reviews and interviews, the hospital staff failed to ensure nurses, who were delivering babies, were in compliance with State Licensure Law for nursing practice for 21 of 26 patients with nurse deliveries without the attendance of a physician. (Patients #12, 14, 15, 16, 17, 18, 19, 23, 24, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 and 26).

The findings included:

Review on 01/16/2018 of 21 NCAC 36.0224 Registered Nurse components of nursing practice revealed no documentation that non-certified Obstetrical Registered Nurses were permitted to practice medicine for the delivery infants without the attendance of a physician in non-emergent situations.

Review on 01/16/2017 of General Statue Section 90-178.2 revealed, "(1) ...(2) ...(3) Midwifery ...does not include the practice of medicine by a physician licensed to practice medicine when engaged in the practice of medicine as defined by law, the performance of medical acts by a physician assistant or nurse practitioner when performed in accordance with the rules of the North Carolina Medical Board, the practice of nursing by a registered nurse engaged in the practice of nursing as defined by law, or the rendering of childbirth assistance in an emergency situation..."

Review on 01/12/2018 of the hospital's "MEDICAL STAFF BYLAWS" APPENDIX B, "ARTICLE VI - EMERGENCY MEDICAL, SCREENING, TREATMENT, TRANSFER & ON-CALL ROSTER POLICY" approved 01/12/2018 revealed, "6.1 SCREENING, TREATMENT & TRANSFER 6.1(a) Screening (1) ...(2) ...(3) All patients shall be examined by qualified medical personnel. Qualified medical personnel include: (a) ...(b) The following health care professional who are deemed qualified through Human Resources competency evaluations may participate in performing the medical screening examination under the supervision of a qualified physician: (i) Registered Nurses in Labor and Delivery trained in obstetric nursing, where permitted under State law and Hospital policy, who may determine true, false, or no labor but may not make a medical diagnosis..."

1. Closed medical record review on 01/22/2108 revealed on 01/18/2017 at 2149, Patient #12, a 33 year-old OB (obstetrical) patient presented to the hospital's ED (Emergency Department) with complaints of contractions. The patient had an estimated gestational age of 39-weeks and 4-days. The patient was escorted to the OB unit, examined and monitored continuously. On 01/19/2017 at At 0550, OB Physician #17 was notified of the patient's status. At 0600 (7 hours and 11 minutes later), the patient was admitted to and monitored while on the obstetrical unit. At 0605 and 0615, OB Physician #17 was notified of the patient's status. At 0625 OB Physician #17 examined the patient. At 1001, the patient had a NSVD (normal spontaneous vaginal delivery) with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #3 (Obstetrical Registered Nurse) was possibly present and participated with the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #3 personnel file was reviewed by SA consultant #2. Review revealed the nurse had nursing license and obstetrical education requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

2. Closed medical record review on 01/22/2018 revealed on 12/22/2016 at 2240, Patient #14, a 25 year-old OB patient presented to the OB unit for an OB check-up secondary to contractions. The patient had an estimated gestational age of 40-weeks. At 2251, OB RN #8 performed the 1st SVE (Sterile Vaginal Examination) and the patient was found to be ready for delivery. OB Physician #17 was notified. At 2305, SROM (Spontaneous Rupture of Membranes) occurred and the patient underwent a 2nd SVE; at which time, the patient was moved to a labor-delivery room. At 2306, patient was crowning and at 2313, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #8 was possibly present and participated with the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #8 personnel file was reviewed by SA consultant #2 which revealed the nurse had nursing license and obstetrical education requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

3. Closed medical record review on 01/22/2108 revealed on 11/29/2016 at 0603, Patient #15, a 24 year-old OB patient presented to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 37-weeks. From 0618 to 1106 (4 hours and 48 minutes), the patient was monitored by the OB nursing staff. At 1107 the patient was admitted to the hospital and at1130, per orders, the patient was moved to a labor and delivery room. Review revealed at1408, OB RN #1 performed the 4th SVE and, a physician was notified while the OB nursing staff continued to monitor the patient. At 1530, a physician was notified to come to delivery. At 1540, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated with the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

4. Closed medical record review on 01/23/2018 revealed on 07/22/2016 at 2055, Patient #16, a 34 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39 weeks. Upon arrival to the OB unit, OB RN #2 performed a vaginal exam and the results were SROM and the patient was crowning. Review revealed the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated with the delivery.
.
Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

5. Closed medical record review on 01/23/2018 revealed on 11/15/2016 a 2140, Patient #17, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39 weeks. At 2145, OB RN #18 performed a SVE. At 2319 (94 minutes later), OB Physician #16 was notified of the patient's arrival and condition; at which time, orders were received. On 11/16/2016 at 0318, OB Physician #17 notified of 2nd SVE results. At 0410, OB Physician #17 present and performed the 3rd SVE and the patient was admitted to labor and delivery. At 0420, OB Physician #17 performed the 4th SVE. At 0730, OB RN #13, performed the 5th SVE without physician notification of results. At 0845, OB RN #2 performed the 6th SVE without physician notification of results. At 0900, OB RN #2 performed the 7th SVE without physician notification of results. At 0915, OB RN #2 performed the OB 7th SVE and the results were communicated to OB Physician #17. At 0930, OB RN #2 performed the 8th SVE without physician notification of results. At 0945, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated with the delivery.
.
Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

6. Closed medical record review on 01/23/2018 revealed on 11/03/2016 at 0455, Patient #18, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 38 weeks. At 0515, OB RN #14 performed the 1st SVE and a physician was notified of the results; at which time, admission orders were received. At 0600, OB RN #14 performed the 2nd SVE and a physician was in the room with the patient. At 0630, OB RN performed the 3rd SVE without physician notification of results. At 0650, the patient experienced SROM, a physician was notified and at 0654, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #14 was possibly present and participated with the delivery.
.
Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Team discussion on 01/24/2018 at 1615 between SA (State Agency) consultants #1 and #2 revealed OB RN (Obstetrical Registered Nurse) #14 personnel file was reviewed by SA consultant #2 and revealed nursing licensure and obstetrical educational requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies

7. Closed medical record review on 01/23/2018 revealed on 09/23/2016 at 0352, Patient #19, a 29 year-old OB patient 1st presentation to the OB unit for an OB checkup secondary to contraction. At 0615, OB RN #14 performed the 1st SVE without physician notification of results. At 0622, a physician was at the patient bedside, examination performed, the patient was educated on when to come back and the patient was discharged. Review revealed at 1625, the OB patient presented back to the OB unit via EMS (Emergency Medical Service) for possible labor. OB RN #2 performed the 1st SVE and OB Physician #16 was notified. At 1632, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and paticipated with the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

8. Closed medical record review on 01/23/2018 revealed on 06/16/2016 at 0700, Patient #23, a 42 year-old OB patient 1st presentation to the OB unit for Day 2 of cervical ripening. At 0829, OB Physician #16 performed the 1st SVE. At 1000, a OB nursing staff performed the 2nd SVE and the results were no change. OB RN #2 discharged the patient to home with the verbal understanding to return if contractions become stronger. Review revealed at 1145, the OB patient presented back to the OB unit with complaints of labor. A SVE was performed and the result was the patient was crowning. OB Physician #16 notified for delivery. The patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RN #2 was possibly present and participated with the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements as a qualified evaluator were met. Review revealed the nurse was not licensed to deliver babies.

9. Closed medical record review on 01/22/2018 revealed on 11/30/2016 at 0500, Patient #24, a 25 year-old OB patient presented to the OB unit for a checkup secondary to contractions. At 0500, OB RN #25 performed the 1st SVE without physician notification of results. At 0530, OB Physician #16 performed the 2nd examination. At 0630, a physician saw and examined the patient and OB RN #14 received labor and delivery admission orders. At 0825, OB Physician #17 performed the 3rd examination. Review revealed at 0925, OB RN #6 performed the 4th SVE without physician notification of results. At 0955/1000, OB RN #6 performed the 5th SVE without physician notification of results. At 1115, OB Physician #17 was notified of the patient's status and orders were received. At 1128, the patient continued to have contractions and OB RN #2 notified OB Physician #17 of the patient's status and requested presence for delivery. At 1140, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Review revealed OB RNs #2 and #14 were possibly present and paticipated with the delivery.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses.

Personnel file review on 01/24/2018 of OB RNs #2 and #14 revealed the nurses had nursing licenses and obstetrical nursing educational requirements as qualified evaluators were met. Review revealed the nurses were not licensed to deliver babies.



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10. Closed medical record review on 01/22/2018 for Patient #1 revealed a 30 year old, presented to the OB (obstetrical) unit via EMS (Emergency Medical Services) on 06/16/2017 at 1901 with a intrauterine pregnancy at 36 weeks, 6 days. Review of the timeline nursing documentation, revealed at 1903, the patient experienced a spontaneous rupture of membranes (SROM) and voiced the urge to push. Review revealed "nursing staff encouraged pt [patient] not to push and to breathe through contractions until MD (Medical Doctor) arrived." Nursing documentation entered at 1905, revealed [Physician #16] was notified of the patient's status. Review revealed at 1908 (OB RN #5), noted "Delivery of a LFC [Live female child] with nursing staff present. ..." Documentation at 1915 by (OB RN #5), revealed "[Physician #16)] arrived to room...."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018, of OB RN #5's personnel file, revealed she has been an RN since June of 2013, and has a BSN (bachelors of science in nursing) degree. RN #5 was hired on 07/01/2013, and started working on the OB unit on 04/24/2017. Review revealed the nurse was not credentialed to deliver babies.

11. Closed medical record review on 01/23/2018 for Patient #2 revealed a 24 year old at 37 weeks, 4 days arrived to the OB unit exam room on 10/11/2017, at 0828 and was admitted at 0858. Documentation in the timeline of events revealed the patient progressed and at 1550 "([OB RN#6]) entered the patient's room to find the fetal heart rate." At 1551, OB RN#6 documented "Remarks: Trouble finding heart rate. Patient stated she felt like something had dropped. Pulled sheet all the way back and baby's head was between her legs. Pt had no idea it was there. [Director of Birthplace] called to room. [Physician #17] notified and on his way." At 1552, ([OB RN #6]) documented "Delivery of baby. Remarks: Moved patients [sic] legs apart and baby slipped out with out [sic] her pushing. Documentation at 1553 revealed "Delivery of placenta, and at 1554, "Remarks: [Physician #17] in room." Review revealed OB RN #6 did not wait on the physician to clamp and cut the cord or deliver the placenta. The physician arrived one minute after the placenta was delivered.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). Staff #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

12. Closed medical record review on 01/22/2018 for Patient #3's a 24 year old with an intrauterine pregnancy at 34 weeks and 2 days, presented to the OB unit exam room from ED registration on 08/20/2018, at 0409. OB RN #2 documented performed an SVE at 0412 and found the patient to be complete with bulging membranes "that ruptured during the exam....fetal head presenting. [Physician #16] called for delivery and enroute...0413: Infant delivered NSD [normal spontaneous delivery] in exam room... 0415: Placenta delivered [sic]." The OB RN also delivered the placenta and gave oxytocin (with no documented physician order) prior to the physician arriving. The Physician #16 arrived 7 minutes after delivery.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Personnel file review on 01/24/2018 of OB RN #2 revealed the nurse had nursing license and obstetrical nursing educational requirements were met. Review revealed the nurse was not credentialed to deliver babies.

13. Closed medical record review on 01/22/2018 for Patient #4 revealed a 34 year old arrived to the OB unit via EMS. Review revealed at 0612 the patient arrived via EMS with an RN from the ED (Emergency Department), "screaming out in pain. Pt was transferred to LDR(labor and delivery room) bed and examined by [this RN]. Attempted to place EFM [external fetal monitor] and TOCO [an instrument for measuring the force of uterine contractions] but was unable d/t [due to] pt excessively moving in bed. this nurse attempted to calm pt and [Physician #16] was notified of pt arrival to floor stating that he was on his way. RT [Respiratory Therapy] and [name of pediatrician] were also notified to come to delivery. 0616 - Delivery of live female child by this RN. Meconium stained fluid noted." Review revealed the baby was delivered by OB RN #9, four minutes after the patient's arrival to OB unit.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of OB RN #9's personnel file, revealed she has been an RN since July, 2012, and has a two year ADN (Associates Degree in Nursing). Staff #9 was hired on 04/21/2014, and started working on the OB unit on 04/04/2016. Review revealed the nurse was not credentialed to deliver babies.

14. Closed medical record review on 01/23/2018 for Patient #5 revealed a 29 year old at 41 weeks gestation presented to the OB unit exam room on 08/23/2017 at 1030. Review of the nursing timeline documentation by (RN [Staff #4]) on 08/23/2017 at 1030 revealed "Remarks: pt to Exam room from ED registration via ER [Emergency Room] nurse. pt from WC [wheelchair] to stretcher. membranes bulging... [OB RN #3] at bedside. Pt complete and ruptured on exam table. Infant delivered by [Staff #3]. [Physician #16] notified of delivery, states he is in route...LMC (live male child) born at 1020, placenta intact spontaneously at 1027. 20 milliunits of pitocin given IM. Review revealed the baby was delivered by OB RN #3.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of OB RN #3's personnel file, revealed she has been an RN since June, 2015, and has a two year ADN (Associates Degree in Nursing). Staff #3 was hired on 06/23/2003, and started working in L & D on 04/04/2016. Review revealed the nurse was not credentialed to deliver babies.

15. Closed medical record review on 01/23/2017 for Patient #6 closed medical revealed a 27 year old presented to the OB unit exam room from the ED on 08/21/2017 at 1733. [OB RN #11] documentation revealed "Remarks: Pt arrived on unit via w/c from the ER at 0733. She was experiencing a strong contraction at the time. At the end of the contraction I asked her to try to get up and again she said, 'just give me a minute'. Another contraction started immediately and she stated, 'I need to push!' Review revealed, "[Physician #16] was called but it went to voicemail. LFC spontaneously delivered at 0738. [OB RN #1] was then able to reach [Physician #16] and he was on his way."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018, of OB RN #11's personnel file, revealed she has been an RN since 2001and has a two-year ADN degree. RN #11 was hired on 07/23/2002, and started working on the OB unit in 2015. Review revealed the nurse was not credentialed to deliver babies.

16. Closed medical record review on 01/23/2018 for Patient #7 revealed she presented to the OB unit with contractions three to four minutes apart on 09/24/2017 at 1134 with a 41 week, 4 day gestation. Review of the nursing timeline on 09/25/2017 at 1451 revealed, "Remarks: Infant crowning. [Physician #17] notified by [Director of Birthplace]. He is enroute in his car at present. [Director of Birthplace] in to help with delivery. 1453: Delivery of baby. Remarks: Infant delivered NSD by myself." Review revealed the physician arrived one minute after the baby was born.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). OB RN #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

17. Closed medical record review on 01/23/2018 for Patient #8 revealed a 21 year old who presented to the OB unit on 07/26/2017 at 1800 with contractions on day 2 of cervical ripening (labor induction.). Review of timeline documentation revealed the patient was examined by [Physician #17] and orders were received for admission at 1801. Review revealed the patient progressed and [OB RN #8] notified the MD at 2340 of the patient's request for pain medication at which time he stated he was coming in.[Physician #17] arrived to the floor at 0015 and went to the MD call room, instructing the RN to call when ready for him in the delivery room. Review revealed Staff #9 noted at 0032: "Remarks: Updated [name of physician (Staff #17)] of pt status .... Pt stating the urge to push. MD stated to call him when ready for him." Review revealed at 0035, "Remarks: Pt stated she had urge to push. 2 RNS at bedside. Began pushing with patient. 0100: SROM (spontaneous rupture of membranes), delivery of baby. Notified [Physician #17] he was needed at bedside immediately. ... 0101: MD at bedside."

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN#8, revealed she has been an RN since 2014, and has a two year ADN (Associates Degree in Nursing). OB RN #8 was hired on 03/02/2015, and started working on the OB unit on 06/18/2016. Review revealed the nurse was not credentialed to deliver babies.

18. Closed medical record review on 01/22/2018 for Patient #9 revealed a 20 year old presented to the OB unit from ED registration on 06/20/2017 at 0400, with complaints of SROM (spontaneous rupture of membranes) at 0300. Upon arrival the patient experienced a SROM and was examined by [Physician Staff #17].The patient was admitted at 0711 with premature rupture of membranes at 39 weeks, 4 days gestation. Review of the nursing timeline documentation revealed the patient was examined by OB RN #6 at 1553. At 1554 OB RN #6 noted, "[Physician Staff #16] called to check on patient status. Updated him that patient was now complete, but no urge to push... To call him when we are ready." Review revealed, "1604: Patient starting to push with contractions, 1635: [Physician Staff #16] called to attend delivery." Review revealed the baby was delivered at 1639 as [Physician #16] walked in the room.

Interview on 01/12/2018 at 0930 with the Interim CNO revealed as related to the nurse deliveries - precipitous deliveries were not approved by the board of nursing as a scope of practice for OB nurses per State Agency Consultant #1's interview findings.

Telephone interview on 01/16/2018 at 1530 with a NCBON (North Carolina Board of Nursing) representative revealed the NCBON did not support nurses delivering babies. The scope of practice was based upon nursing school education and nursing school does not teach nurses how to deliver babies per State Agency Consultant #1's interview findings.

Review on 01/24/2018 of the personnel file for OB RN #6, revealed she has been an RN since August, 1995, and has a two year ADN (Associates Degree in Nursing). OB RN #6 was hired on 01/27/1997, and started working on the OB unit on 03/23/2016. Review revealed the nurse was not credentialed to deliver babies.

19. Closed medical record review on 01/22/2018

Based on policy and procedure review, medical record review and staff interviews, the hospital nursing staff failed to obtain a physician's order prior to discharge for 5 of 25 patients (Patients #11, 27, 28, 19 and 23).

The findings included:

Review on 01/10/2018 of the hospital's policy titled, "Discharge of Patient, D-50-OB-55"approved 08/2017, revealed "...1. Check patient's chart for discharge orders. ..."

1. Closed medical record review on 01/16/2018 for Patient #11 revealed a 41 year-old presented to the L&D department on 06/16/2016 at 0648 for "day 2 of cervical ripening." Review revealed monitoring was initiated and the patient was evaluated by (Physician) [Staff #16] at 0830. Review of the nursing progress notes by (RN) [Staff #8] revealed, " ...plan of care reviewed with patient, pt verbalized an understanding and agreed. up to walk for 1 hour then recheck for cervical change. ..." Review revealed (RN) [Staff #2] noted, "Remarks: No cervical change present with vaginal exam. Monitor reapplied" at 1000 and at 1030, (RN) [Staff #2] noted the patient was "discharged home. verbalizes that she will return if contxs (contractions) become stronger." [sic] Review failed to reveal further consultation with the attending (Staff #16) or other physician. Continued review revealed the patient returned to the hospital at 1145 and was admitted at 1208. Review of the nursing progress note by Staff #2 revealed, "Remarks: 1145: Pt return for labor complaints. ...SVE done. Pt crowning, [Physician] (Staff #16) called for delivery. Infant delivered. Review of the physician progress note dated 06/17/2016 at 0619 by (Physician) [Staff #16] revealed, "...On her 2nd day (of cervical ripening), ...she was kept approximately 5 hours and had no significant changes, ...She ambulated again and was rechecked by nursing , which was no check and was discharged home. She presented approximately 2-3 hours later with contractions and it was crowning.

Interview on 01/10/2018 at 1630 with Staff #20 revealed the discharging nurse (Staff #2) was no longer employed by the hospital and was not available for interview. Interview revealed the on-call physician (Staff #16) was also not available for interview. Interview revealed a discharge order is required for patients who do not leave the hospital against medical advice (AMA). Interview revealed if the physician fails to enter the order into the electronic medical record (EMR), a verbal or telephone order should be entered. Interview confirmed nursing staff failed to ensure a discharge order was present.

Interview on 01/11/2018 at 1325 with (Physician) [Staff #17] revealed patients should not be discharged without an order. Interview revealed, "Why would a nurse discharge a patient without an order? We always have a phone." Interview confirmed nursing staff failed to check the patient's discharge order per policy.

2. Closed medical record review on 01/10/2018 for Patient #27 revealed a 22 year-old presented to the ED on 10/14/2017 via EMS with "complaints of contractions, increasing in intensity", transported to L&D at 0355 and admitted at 0712. Review of the H&P dated 10/14/2017 at 1012 by (Physician) [Staff #17] revealed the patient was admitted for cervical ripening and delivery. Review of the Delivery Note by (Physician) [Staff #17] revealed, "...She had a normal spontaneous delivery..." (of Patient #25 below) with [Physician] (Staff #17) present. Review of the Discharge Summary dated 10/16/2017 at 0704 by [Physician] (Staff #17) revealed the patient was "Discharge home on 10/17/2017" with a discharge diagnosis of "1. A 39 week and 6 days intrauterine pregnancy. ..." Continued review failed to reveal an order for discharge.

Interview on 01/10/2018 at 1440 with (RN) [Staff #8] revealed she was the primary nurse assigned to Patient #27 on 10/16/2017 and that she discharged her. Interview revealed this situation was "rare". Interview revealed, "I usually check to make sure" there is an order prior to discharge. Interview revealed discharges are discussed in the morning during rounds at which time the physician and multidisciplinary team determine discharge plans. Interview revealed it was an oversight not to ensure a discharge order had been obtained. Following review of physician orders, Staff #8 confirmed there was no discharge order present.

Interview on 01/10/2018 at 1630 with Staff #20 revealed a discharge order is required for patients who do not leave the hospital against medical advice (AMA). Interview revealed if the physician fails to enter the order into the electronic medical record (EMR), a verbal or telephone order should be entered. Interview confirmed nursing staff failed to check the patient's discharge order per policy.

Interview on 01/11/2018 at 1325 with (Physician) [Staff #17] revealed patients should not be discharged without an order. Interview revealed, "Why would a nurse discharge a patient without an order? We always have a phone." Interview confirmed nursing staff failed to check the patient's discharge order per policy.

3. Closed medical record review on 01/10/2018 for Patient #28 revealed an infant female was delivered 10/14/2017 at 2130 (to Patient #3 above) and admitted at 2141. Review of the Physical Exam dated 10/15/207 at 1030 by (Physician) [Staff #20] revealed, "...Term newborn doing well." Review revealed no complications during the delivery process. Continued review revealed a note on 10/16/2017 at 0820 by (Physician) [Staff #21] stating, "...Plan: D/C (discharge) home and follow up in 2-3 days. ..." Continued review failed to reveal an order for discharge.

Interview on 01/10/2018 at 1440 with (RN) [Staff #8] revealed she was the primary nurse assigned to Patient #28 on 10/16/2017 and that she discharged her. Interview revealed this situation was "rare". Interview revealed, "I usually check to make sure" there is an order prior to discharge. Interview revealed discharges are discussed in the morning during rounds at which time the physician and multidisciplinary team determine discharge plans. Interview revealed failure to ensure a discharge order was present on the chart prior to implementation was an oversight. Following review of physician orders, Staff #8 confirmed there was no discharge order present.

Interview on 01/10/2018 at 1630 with Staff #20 revealed a discharge order is required for patients who do not leave the hospital against medical advice (AMA). Interview revealed if the physician fails to enter the order into the electronic medical record (EMR), a verbal or telephone order should be entered. Interview confirmed nursing staff failed to check the patient's discharge order per policy. Interview revealed [Staff #21] (attending pediatrician) was not available for interview.

Interview on 01/11/2018 at 1325 with (Physician) [Staff #17] revealed patients should not be discharged without an order. Interview revealed, "Why would a nurse discharge a patient without an order? We always have a phone." Interview confirmed nursing staff failed to check the patient's discharge order per policy.








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4. Closed medical record review on 01/23/2108 revealed on 09/23/2016 at 0352, Patient #19, a 29 year-old OB (obstetrical) patient presented to the OB unit for a checkup secondary to complaints of contractions. The patient had an estimated gestational age of 38+ weeks. The patient was examined by OB Physician #17. The examination determined the patient had false labor and plan was to discharge the patient to home. At 0622, OB Nurse #14 discharged the patient home. Review revealed the discharge plan had no corresponding no discharge order.

Interview on 01/22/2018 at 1145 with the Director of Quality, Risk/Patient Safety revealed all patients should have a discharge order. Interview revealed the process would be the same as if a patient was discharged from the ED (Emergency Department).


5. Closed medical record review on 01/23/2108 revealed on 06/16/2016 at 0352, Patient #23, a 42 year-old OB (obstetrical) patient presented to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 39+ weeks. At 0829 and at 0830, the patient was examined by OB Physician #16. The examination determined no change with cervical dilation and the plan was to discharge the patient home and to return if contractions become stronger. At 1030, OB Nurse #2 discharged the patient home. Review revealed the discharge plan had no corresponding no discharge order.

Interview on 01/22/2018 at 1145 with the Director of Quality, Risk/Patient Safety revealed all patients should have a discharge order. Interview revealed the process would be the same as if a patient was discharged from the ED (Emergency Department).

Based on policy and proced ure review, medical record reviews and staff interviews, the hospital failed to have an effective pharmaceutical service providing oversight of day to day operation to ensure the safe administration of all medication products used in the hospital.

The findings included:

The hospital staff failed to ensure medications were adminstered according to policy and physician order for 15 of 26 patients with medication administration.


~refer to §482.25(b)(1) Pharmaceutical Service Standard: Tag A0501

Based on policy and procedure review, medical record reviews and staff interviews, the hospital staff failed to ensure medications were adminstered according to policy and physician order for 15 of 26 patients with medication administration (Patients #11, 16, 17, 18, 19, 23, 1, 2, 3, 5, 6, 7, 8, 10 and 25).

The findings included:

Review on 01/10/2018 of the hospital's policy, "Administration of Drugs (General), D-50-A-23" revised 11/2016, approved 11/2016 expiration 11/2019 revealed, "STATEMENT OF PURPOSE/POLICY: Administration of drugs shall be in accordance with all the laws of North Carolina, federal laws, rules, and regulations that govern such acts, and the medical staff rules and regulations. PERSONNEL: Pharmacy, Nursing, Medical Staff PROCEDURE: REQUIREMENT FOR A VALID ORDER Individuals who prepare, dispense, and administer drugs shall do so only upon the order of a practitioner who has been granted clinical privileges at [Hospital] and is legally authorized to prescribe/order drugs in the state of North Carolina. Drugs shall be prepared and administered in accordance with the orders of the prescriber or practitioner responsible for the patient's care and acceptable standards of practice. PERSONS AUTHORIZED TO ADMINISTER DRUGS ...Personnel Authorized to Administer Medications: 1. Registered nurses who have successfully completed training in the eMAR (electronic Medication Administration Record) ...PROCESS: MEDICATION ORDERS 1 ...111. Medication Orders may be provided by a physician or physician extender or staff. 1. Providers shall enter all medication orders into CPOE (Computerized Physician Order Entry) Meditech Electronic Medical Record unless situations or procedure dictate otherwise. 2 ...a. Telephone/verbal orders must immediately be recorded on the Physician Order Sheet and "read back" to the physician, physician extender or RN to verify accuracy. Nurse or Pharmacist receiving the verbal order must enter order provided into CPOE Meditech and document as a verbal order. The provider must electronically sign the CPOE order before the Medical record is complete. Verbal orders should only be taken in emergency situations ...3. The eMAR (electronic Medication Administration Record) is available in Meditech...4 ...5 ...6. Medications orders may be entered into the eMAR by the Provider, Nurse or Pharmacist via the Enter Med function. The staff nurse who receives the new medication order and/or administers the first dose of a medication MUST acknowledge (verify) it with the physician's order ...7 ...8 ...9 ...DRUG ADMINSTRATION PROCEDURE ...Verify drugs to be administered with the prescriber's order. Refer to the EMR (Electronic Medical Record) and ensure that the dose is correct and that the drug is not contraindicated ...1 ...2 ...3 ...MEDICATION ADMINISTRATION DOCUMENTATION I. Barcode Scanning prior to medication administration. 1. All medications must be barcode scanned before administration ....II ...III. Documentation of Medication Administration 1. Documentation of medication administration is to be done in the patient's electronic Medication Administration Record (eMAR) as the medication is administered. 2. Documentation of medication administration is to be done by the nurse administering the medication. The only exception to this practice should be reserved for emergent situations such as during labor, surgery, moderate sedation, code situations, etc ....13. Scheduled meds may be administered up to 60 minutes prior to the scheduled time or up to 60 minutes after the time ...Single orders should be given as ordered ..."

1. Closed medical record review on 01/22/2018 revealed on 04/14/2017 at 0916, Patient #11, a 22 year-old patient presented to the hospital for an OB (obstetrical-childbirth) checkup. The patient had an estimated gestational age of 40+ weeks. At 1128, the patient had a NSVD (normal spontaneous vaginal delivery) of a viable child with a physician present. At 1130, 20 units of Oxytocin (contraction/hemorrhaging medication) in one liter of LR (lactated ringers-fluids) was not scanned but administered to the patient by OB RN (registered nurse-licensed) #18. Review failed to reveal a physician order Oxytocin in one liter of LR.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interviewees revealed at the end of each shift, pharmacy discrepancies should be resolved and it was unknown if pharmacy was reviewing [Birthplace electronic] documentation system to resolve a discrepancy. Interview revealed patient safety comes before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed all medications were obtained from the automated dispensing machine. If a medication was not administered but opened, the nurse should be waste and documented in [hospital-wide electronic] documentation system. If a nurse does not open medication from automated dispensing machine the the nurse should return the medication to the external locked box located on the outside of the automated dispensing machine. Interview revealed override and discrepancy reports print to each Director every morning and [hospital-wide electronic] documentation system would alert the nurse when medication was not given and the alert would remain until charting occurs. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

2. Closed medical record review on 01/23/2018 revealed on 07/22/2016 at 2055, Patient #16, a 34 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. At 2055, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Order review revealed a physician ordered Methergine (contraction) 0.2mg PO every six hours with a start date/time of 07/22/2016 at 0000 and a stop date/time of 07/24/2016 at 1801. Methergine last administration was 07/24/2016 at 1814 (13 minutes after stop time). Review revealed the nurse administered Methergine after stop date/time. Order review revealed a physician ordered Oxytocin 10 units IM (intramuscular) once with a start date/time of 07/23/2016 at 0204 and s stop date/time of 07/23/2016 at 0205. At 2100, OB RN #2 scanned and administered the medication to the patient. Further review revealed OB RN #2 documentation revealed OB RN #13 administered medication, time not documented, to the patient. At 0309, OB RN #13 acknowledged the order and documented not given due to duplicate order. Review revealed the nurse acknowledging the Oxytocin order failed to administer the medication.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interviewees revealed at the end of each shift, pharmacy discrepancies should be resolved and it was unknown if pharmacy was reviewing [OB electronic] documentation system to resolve a discrepancy. Interview revealed patient safety comes before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed all medications were obtained from the automated dispensing machine. If a medication was not administered but opened, the nurse should be waste and documented in [hospital-wide electronic] documentation system. If a nurse does not open medication from automated dispensing machine the the nurse should return the medication to the external locked box located on the outside of the automated dispensing machine. Interview revealed override and discrepancy reports print to each Director every morning and [hospital-wide electronic] documentation system would alert the nurse when medication was not given and the alert would remain until charting occurs. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

3. Closed medical record review on 01/23/2018 revealed on 11/15/2016 a 2140, Patient #17, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 39+ weeks. On 11/16/2016 at 0035 and at 0545, the patient was administered Tylenol. Review failed to reveal a physician order for Tylenol. At 0955, the patient was administered 20 units of Oxytocin in one liter of LR at bolus rate. Order review revealed an order for Oxytocin in one liter at 150 mls/hr. (milliliters/hour). Review revealed the patient was not administered Oxytocin in LR at the prescribed rate.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interviewees revealed at the end of each shift, pharmacy discrepancies should be resolved and it was unknown if pharmacy was reviewing [OB electronic] documentation system to resolve a discrepancy. Interview revealed patient safety comes before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed all medications were obtained from the automated dispensing machine. If a medication was not administered but opened, the nurse should be waste and documented in [hospital-wide electronic] documentation system. If a nurse does not open medication from automated dispensing machine the the nurse should return the medication to the external locked box located on the outside of the automated dispensing machine. Interview revealed override and discrepancy reports print to each Director every morning and [hospital-wide electronic] documentation system would alert the nurse when medication was not given and the alert would remain until charting occurs. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

4. Closed medical record review on 01/23/2018 revealed on 11/03/2016 at 0455, Patient #18, a 25 year-old OB patient presented to the OB unit for an OB checkup secondary to contractions. The patient had an estimated gestational age of 38 weeks. At 0654, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. At 0701, the patient was administered 20 units of Pitocin by OB RN #10 but the medication was scanned and administered by OB RN #14. Order review revealed no order for 20 units of Pitocin. Review revealed the medication was scanned once and possibly administered twice without a second physician order.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interviewees revealed at the end of each shift, pharmacy discrepancies should be resolved and it was unknown if pharmacy was reviewing [OB electronic] documentation system to resolve a discrepancy. Interview revealed patient safety comes before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed all medications were obtained from the automated dispensing machine. If a medication was not administered but opened, the nurse should be waste and documented in [hospital-wide electronic] documentation system. If a nurse does not open medication from automated dispensing machine the the nurse should return the medication to the external locked box located on the outside of the automated dispensing machine. Interview revealed override and discrepancy reports print to each Director every morning and [hospital-wide electronic] documentation system would alert the nurse when medication was not given and the alert would remain until charting occurs. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

5. Closed medical record review on 01/23/2018 revealed on 09/23/2016 at 0352, Patient #19, a 29 year-old OB patient presented to the OB unit for an OB checkup secondary to contraction. The patient had an estimated gestational age of 38+ weeks. At 1632, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Order review revealed a physician ordered Oxytocin 10 units IM once with a start time of 1714 and a stop time of 1715. At 1637, Oxytocin was not scanned but administered to the patient by OB RN #2. At 1720, Oxytocin was scanned and administered to the patient by OB RN #4. Review revealed Oxytocin was scanned once and possibly administered twice by two different nurses.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interviewees revealed at the end of each shift, pharmacy discrepancies should be resolved and it was unknown if pharmacy was reviewing [OB electronic] documentation system to resolve a discrepancy. Interview revealed patient safety comes before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed all medications were obtained from the automated dispensing machine. If a medication was not administered but opened, the nurse should be waste and documented in [hospital-wide electronic] documentation system. If a nurse does not open medication from automated dispensing machine the the nurse should return the medication to the external locked box located on the outside of the automated dispensing machine. Interview revealed override and discrepancy reports print to each Director every morning and [hospital-wide electronic] documentation system would alert the nurse when medication was not given and the alert would remain until charting occurs. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

6. Closed medical record review on 01/23/2018 revealed on 06/16/2016 at 0700, Patient #23, a 42 year-old OB patient to the OB unit for Day 2 of cervical ripening. The patient had an estimated gestational age of 39+ weeks. At 1145, the patient had a NSVD with nurse delivery of a viable child without the attendance of a physician. Order review revealed a physician order Methergine 0.2 mg IM once with a start date/time of 06/16/2016 at 1457. At 1150 (187 minutes prior to start time), Methergine was not scanned but administered to the patient by OB RN #2. Further review revealed at 1501, Methergine was scanned and administered at 1501 to the patient by OB RN #2. Review revealed Methergine was scanned once and possibly administered twice by the same nurse.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interviewees revealed at the end of each shift, pharmacy discrepancies should be resolved and it was unknown if pharmacy was reviewing [OB electronic] documentation system to resolve a discrepancy. Interview revealed patient safety comes before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed all medications were obtained from the automated dispensing machine. If a medication was not administered but opened, the nurse should be waste and documented in [hospital-wide electronic] documentation system. If a nurse does not open medication from automated dispensing machine the the nurse should return the medication to the external locked box located on the outside of the automated dispensing machine. Interview revealed override and discrepancy reports print to each Director every morning and [hospital-wide electronic] documentation system would alert the nurse when medication was not given and the alert would remain until charting occurs. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.





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7. Closed medical record on 01/22/2018 revealed on 06/16/2017 at 1901, Patient #1, a 30 year old with an intrauterine pregnancy at 36+ weeks presented to the OB unit exam room via EMS (Emergency Medical Services). At 1915, a baby girl was delivered. At 1920, the placenta was delivered by Physician #16 and OB RN #5, administered the patient of 20 U (units) of Oxytocin in 500 ml (milliliters) of LR. Review of the MAR (Medication Administration Record) revealed there was no documented physician order for the bolus of Oxytocin nor any documentation a bolus of Oxytocin was administered.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace, revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interview revealed patient safety came before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed override and discrepancy reports printed to each Director every morning and the electronic system would alert the nurse when medication was not given. The alert would remain until charting occurred. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

Interview on 01/23/2018 at 1445, with the Director of Birthplace, revealed the physicians were to enter their orders when they were in the facility. Interview revealed administered medications should be documented on both the [Birthplace electronic] documentation system and the MAR. "The physicians will look in [Birthplace electronic] documentation system to see what they [patients] have had." Interview revealed the L & D summary "is redundant...That piece is now in [hospital-wide electronic] documentation system. The interview revealed "The L & D Summary and delivery data is something they are trying to make electronic, so we can get rid of that sheet." Interview confirmed the L & D summary was still part of the medical record.

Interview on 01/24/2018 at 1035, with the CEO, the CNO, and the Director of Quality, Risk and Patient Safety, revealed the timeline charting was the "older" Birthplace charting. When the facility added the system for the MAR, they didn't get rid of the timeline charting. Interview revealed in labor and delivery there were two RNs in the room. Often one RN does the charting while the other RN takes care of the patient. "We've always done it this way so we have a timeline... We have three forms - The MAR, the timeline and the L & D Summary...Three places to document the same thing. It's a symptom of adding and adding and forgetting to subtract... We aren't making it easy for the nurses to do the right thing. I don't think the nurses are doing any malfeasance, they are helping each other."

8. Closed medical record review on 01/23/2018 revealed on 10/11/2017 at 0858, Patient #2, a 24 year old was admitted to the OB unit. The patient had an estimated gestestional age of 37+ weeks. At 1603, OB RN #6 administered the patient a bolus of 20 units of Oxytocin in 500 ml LR. Review of the MAR, revealed no physician order for the bolus of Oxytocin nor any documentation a bolus of Oxytocin was administered.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace, revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interview revealed patient safety came before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed override and discrepancy reports printed to each Director every morning and the electronic system would alert the nurse when medication was not given. The alert would remain until charting occurred. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

Interview on 01/23/2018 at 1445, with the Director of Birthplace, revealed the physicians were to enter their orders when they were in the facility. Interview revealed administered medications should be documented on both the timeline documentation and the MAR. "The physicians will look in [the name of the timeline system] documentation to see what they [patients] have had." Interview revealed the L & D summary "is redundant...That piece is now in [name of system for the MAR]. The interview revealed "The L & D Summary and delivery data is something they are trying to make electronic, so we can get rid of that sheet." Interview confirmed the L & D summary was still part of the medical record.

Interview on 01/24/2018 at 1035, with the CEO, the CNO, and the Director of Quality Assurance, revealed the timeline charting was the "older" OB charting. When the facility added the system for the MAR, they didn't get rid of the timeline charting. Interview revealed in L & D, there are two RNs in the room. Often one RN does the charting while the other RN takes care of the patient. "We've always done it this way so we have a timeline... We have three forms - The MAR, the timeline and the L & D Summary... Three places to document the same thing. It's a symptom of adding and adding and forgetting to subtract... We aren't making it easy for the nurses to do the right thing. I don't think the nurses are doing any malfeasance, they are helping each other." Interview revealed since the hurricane, Pharmacy has been mixing the Oxytocin and "it comes down to L & D without a bar code.

9. Closed medical record review on 01/22/2018 revealed on 08/20/2018 at 0409 Patient #3, a 24 year old presented to the OB examination room. The patient had an estimated gestational age of 34 and 2/7 weeks. At 0412, OB RN #2 performed a SVE and notified a physician of the patient's status. At 0413, the patient had a nurse delivery of a viable child without the attendance of a physician. Review revealed at 0414, the placenta was delivered, Pitocin [oxytocin] 10 mU's given IM per OB RN #25. At 0420, Physician #16 was at the patient's bedside. Review of the L & D Summary revealed the Oxytocin, 10 units IM, was administered at 0416 by OB RN #2. Review of the MAR showed there was no order for the 10 units of Oxytocin IM but there was an override in the automated dispensing machine by OB RN #2 at 0420 for the 10 units of Oxytocin. Review revealed at 0445, a physician order for LR, 1000 ml at 150 ml/hr. No documentation of the administration of the LR could be found in the MAR.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace, revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interview revealed patient safety came before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed override and discrepancy reports printed to each Director every morning and the electronic system would alert the nurse when medication was not given. The alert would remain until charting occurred. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

Interview on 01/23/2018 at 1445, with the Director of Birthplace, revealed the physicians were to enter their orders when they were in the facility. Interview revealed administered medications should be documented on both the timeline documentation and the MAR. "The physicians will look in [the name of the timeline system] documentation to see what they [patients] have had." Interview revealed the L & D summary "is redundant...That piece is now in [name of system for the MAR]. The interview revealed "The L & D Summary and delivery data is something they are trying to make electronic, so we can get rid of that sheet." Interview confirmed the L & D summary was still part of the medical record.

Interview on 01/24/2018 at 1035, with the CEO, the CNO, and the Director of Quality Assurance, revealed the timeline charting was the "older" OB charting. When the facility added the system for the MAR, they didn't get rid of the timeline charting. Interview revealed in L & D, there are two RNs in the room. Often one RN does the charting while the other RN takes care of the patient. "We've always done it this way so we have a timeline... We have three forms - The MAR, the timeline and the L & D Summary...Three places to document the same thing. It's a symptom of adding and adding and forgetting to subtract... We aren't making it easy for the nurses to do the right thing. I don't think the nurses are doing any malfeasance, they are helping each other." Interview revealed since the hurricane, Pharmacy has been mixing the Oxytocin and "it comes down to L & D without a bar code. Interview revealed the administration now had something in place so nurses could no longer override medications in the automated dispensing machine.

11. Closed medical record on 01/23/2017 revealed on 08/21/2017 at 1733 Patient #6, a 27 year old who presented to the L & D exam room from the ED. The patient delivered five minutes after arriving to the unit. RN #11's documentation revealed "Expulsion of placenta occurred spontaneously at 0752. 10mg pitocin given IM in left thigh and fundal massage performed. Pt transported to LDR 1 via stretcher... [Physician (Staff #16)] to room to examine pt and expel clots. Methergine 0.2.mg (used for the prevention and control of postpartum hemorrhage), given IM in left deltoid..." Review revealed the RN clamped and cut the cord and the "expulsion of the placenta occurred spontaneously 14 minutes after the delivery. Review of the patient's MAR, revealed Pitocin (oxytocin), 10 units IM, once was ordered by the physician at 0825 "to be given at 0752." Review revealed the pitocin was documented as administered by (RN (Staff #11]) at 0747 (five minutes prior to order). Review of the timeline documentation revealed the 10 units of Pitocin IM was administered at 0752 by Staff #11 (the same time as the order), and the L& D Summary revealed the Pitocin, 10 units IM, were administered by Staff #1 (not RN #11, as documented in the MAR and the timeline documentation). Continued review revealed an order for Methergine 0.2 mg IM ordered in the MAR at 0825. The administration time in the MAR was documented as 1944 by Staff #11. The timeline documented the Methergine was administered, but did not give a time. The L & D Summary documentation revealed the Methergine was administered at "0805" by Staff #1.

Interview on 01/23/2108 at 1100 with Director of Pharmacy and Director of Birthplace, revealed with one time orders: order start date and renewal date/time should be the same and the renewal days for antibiotics, controlled substance and non-controlled substance were 5,7 and 14. Interview revealed patient safety came before time management and the Pharmacy Department had oversight of all automated dispensing machines in the hospital. Interview revealed override and discrepancy reports printed to each Director every morning and the electronic system would alert the nurse when medication was not given. The alert would remain until charting occurred. Interview revealed there was a 24-hour report where each Director could audit overrides and discrepancies in the automated dispensing machine, which allowed for all medications to be reviewed from admit to discharge by drug and user. Interview revealed no medication should be administered without a physician order, when physician were onsite, the expectation was for the physician to enter the order.

Interview on 01/23/2018 at 1445, with the Director of Birthplace, revealed the physicians were to enter their orders when they were in the facility. Interview revealed administered medications should be documented on both the timeline documentation and the MAR. "The physicians will look in [the name of the timeline system] documentation to see what they [patients] have had." Interview revealed the L & D summary "is redundant...That piece is now in [name of system for the MAR]. The interview revealed "The L & D Summary and delivery data is something they are trying to make electronic, so we can get rid of that sheet." Interview confirmed the L & D summary was still part of the medical record.

Interview on 01/24/2018 at 1035, with the CEO, the CNO, and the Director of Quality Assurance, revealed the timeline charting was the "older" OB charting. When the facility added the system for the MAR, they didn't get rid of the timeline charting. Interview revealed in L & D, there are two RNs in the room. Often one RN does the charting while the other RN takes care of the patient. "We've always done it this way so we have a timeline... We have three forms - The MAR, the timeline and the L & D Summary...Three places to document the same thing. It's a symptom of adding and adding and forgetting to subtract... We aren't makin

Based on record review and interview, the hospital staff failed to notify the OPO (Organ Procurement Organization) in a timely manner for 1 of 1 stillborn infant for 1 of 26 patients with nurse deliveries. (Patient #10).

The findings included:

Review of the facility policy, "Fetal Death, D-50-NUR-54, revealed "Stillborn infants are those infants born with no sign of life..." The OPO should be called "within one (1) hour of delivery" for stillborn infants of a gestational age of 20 weeks or greater.

Review on 01/22/2018 of Patient #10's medical record, revealed a 24 year old G2, P1, arrived to L & D unit via EMS on 07/04/2017 at 0645 via EMS (Emergency Medical Systems), with vaginal bleeding. An ultrasound, performed at 1000, showed no amniotic fluid, and the gestational age of the fetus by measurement was 21 and 5/7 weeks. Review revealed the fetus was delivered spontaneously at 1335 with no signs of life.

Review of the "Routine Request Form For Organ, Eye, and Tissue Donation," revealed the date of death was 07/04/2017 at 1335. Review revealed the OPO was contacted on 07/05/2018 at 1535 (more than 24 hours after the delivery of the stillborn fetus. Documentation revealed the patient was not a candidate for for organ, tissue, or eye donation due to "Gestational Age." The OPO form was completed and signed by RN #2.

Interview on 01/23/2018 at 1315 with the Director of Quality, revealed the OPO should be called within one hour of the delivery of a stillborn, per policy.


NC00134289 and NC00135046