HospitalInspections.org

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws, the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Governing Body (GB) failed to be responsible for the conduct of the entire hospital.

Findings include:

1.) The GB failed to ensure that the Medical Staff appraised and was accountable to the GB, to evaluate the quality of care provided by Pediatrician #1 to Patients #1, #2, #3 and #4 after 4 MI's were submitted regarding Pediatrician #1's lack of skills in newborn resuscitation.

See 0049

2.) The GB failed to ensure that the Medical Staff used a procedure for applying the criteria for selection of Pediatrician #1, considered competent in providing skills neonatal resuscitation, included preparation and use of neonatal resuscitation equipment and neonatal intubation (inserting a breathing tube), prior to granting Medical Staff privileges.

See 0050

3.) The GB failed to ensure that Pediatrician #1's Medical Staff privileges were not granted, solely dependent on a current neonatal resuscitation training program.

See 0051 and 0341

4.) The GB failed to ensure that Hospital performance improvement activities analyzed (coded) and tracked the Maternity Incidents (MI) #1, #2, #3 and #4 as potential patient harm and sent MI's #1, #2, #3 and #4 to be reviewed by doctors.

See 0273

5.) The GB failed to ensure that the Hospital performance improvement activities analyzed the MI's which lead to the continuation of unsafe practices in neonatal resuscitation.

See 0286

6.) The GB failed to ensure that the Medical Staff appraised Pediatrician #1's clinical competence to perform neonatal resuscitation skills prior to granting Membership to the Medical Staff and Medical Staff privileges.

See 0340

7.) The GB failed to ensure that the Medical Staff ensured the Governing Body that Pediatrician #1's Medical Staff privileges were not solely dependent on a current neonatal resuscitation training program.

See 0341

8.) The GB failed to ensure that the Medical Staff was accountable to the GB for the quality of care provided to patients.

See 0347

9.) The GB failed to ensure that the Medical Staff enforced their own Medical Staff Bylaws to carry out its responsibilities to evaluate Pediatrician #1's competence through a process of proctoring, direct observation and peer review.

See 0353

10.) The GB failed to ensure that the Nursing Service ensured that the Interim Maternity Nurse Manager was educated in Electronic Fetal Monitoring.

See 0392

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4); review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)]; the documents titled: Neonatal Resuscitation Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and interviews, the Governing Body (GB) failed to ensure that the Medical Staff was accountable to the GB for the quality of care provided to patients.


Findings include:

1.) The GB failed to ensure that the Medical Staff appraised and was accountable to the GB in evaluating the quality of care provided by Pediatrician #1 to Patients #1, #2, #3 and #4 after 4 MI's were submitted about Pediatrician #1's lack of demonstrated skills in newborn resuscitation.


Neonatal Resuscitation, 2010 American Heart Association (AHA)/American Academy of Pediatrics (AAP) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care indicated that anticipation, adequate preparation, accurate evaluation, and prompt initiation of support are critical for successful neonatal resuscitation. At every delivery there should be at least 1 person who is promptly available with the skills required to perform endotracheal intubation.

From 2/22/14 through 4/23/14, Pediatrician #1 was involved in 4 births where she did not follow the standards of neonatal resuscitation.

The MI's that occurred on 2/22/14, 4/9/14, 4/21/14 and 4/23/14 indicated that Pediatrician #1 lacked skills in neonatal resuscitation, was not prepared for neonatal resuscitation at a high risk delivery, did not know how to use neonatal resuscitation equipment and did not know how to intubate a newborn (insert a breathing tube).

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that she received the electronic generated MI's when the MI's were generated. VPMA #1 said Pediatrician #1 was Neonatal Resuscitation (NRP, Neonatal Resuscitation Program) certified, was uncomfortable with the equipment in the delivery room and could "maybe" intubate a newly born baby.

VPMA #1 said an anesthesiologist was not necessarily a resource for neonatal intubation. VPMA #1 said she was going to have Pediatrician #1 work with an anesthesiologist at the Hospital or another hospital to improve neonatal intubation skills but the plan was not in place.

VPMA #1 said Pediatrician #1 was counseled about Universal Precautions in the delivery of a baby (wearing gloves when providing care for a newborn). VPMA #1 said she counseled Pediatrician #1 about her responsibility as the team leader in a neonatal resuscitation. VPMA #1 said a plan to have Pediatrician #1 improve her neonatal intubation skills by working with an anesthesiologist was not scheduled and that the Chief of the Anesthesiology Department told her that Pediatrician #1's skills in neonatal intubation were "not retrievable".

Although VPMA #1 was aware of each incident, she told the Maternity Nurse Manager to counsel Pediatrician #1 about wearing gloves at a delivery and did not personally have a conversation with Pediatrician #1 after MI #1 or take corrective action(s). VPMA #1 said she did not have a conversation with Pediatrician #1 after MI #2, which occurred on 4/9/14, until 4/24/14. Two other incidents occurred after 4/9/14, MIs, #3 and MI #4 which were not discussed on 4/24/14. A corrective action plan was not developed, therefore leaving newborns in the care of Pediatrician #1 at risk of serious harm to health and safety.

See 0347

Based on review of the Medical Staff Bylaw, review of Maternity Incidents (MIs ##1) credential file review for Pediatrician #1 and interviews, the GB failed to ensure that the Medical Staff used a procedure for applying the criteria for selection of Pediatrician #1, including competence in neonatal resuscitation, prior to granting Medical Staff privileges.

Findings include:

The Medical Staff Bylaws policy titled: Focused Professional Practice Evaluation (FPPE), dated 4/2012, indicated each practitioner had his/her performance measured, monitored, evaluated and documented by the Chair of the Department and when a question arises regarding a practitioner's ability to provide safe and high quality patient care. The policy indicated that the Medical Staff evaluated Medical Staff competence through a process of proctoring, direct observation and peer review.

The Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

Maternity Incident (MI) #1 that occurred on 2/22/14 indicated that Pediatrician #1 did not wear gloves while caring for a newly born baby and was not prepared for neonatal resuscitation at a high-risk delivery.

Review of Pediatrician #1's credentials indicated that she requested intubation privileges and the Board of Trustees granted her full staff privileges to the Department of Pediatrics on 3/19/14.

The Medical Staff was aware of the 4 MI's (2/22/14, 4/9/14, 4/21/14 and 4/23/14) involving Pediatrician #1 and did not measure, monitor or evaluate her performance, according to their own Bylaws.

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high-ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that Pediatrician #1 had completed the Neonatal Resuscitation Program (American Heart Association and American Academy of Pediatrics program on neonatal resuscitation) on 1/31/14.

The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences.

The failure to validate clinical competence left newborn babies vulnerable to a practitioner lacking in neonatal resuscitation skills.

See 0340 and 0341

Based on review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws and interviews, the Medical Staff failed to assure the Governing Body (GB) that Pediatrician #1's Medical Staff privileges in the Hospital were not solely dependent on a current neonatal resuscitation training program.

Findings include:

The Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M., 1:00 P.M. and 3:30 on 5/15/14. VPMA #1 said that Pediatrician #1 completed the Neonatal Resuscitation Program (American Heart Association and American Academy of Pediatrics program) on neonatal resuscitation) on 1/31/14 and Pediatrician #1 was granted temporary privileges on 1/10/14.

Review of Pediatrician #1's credentials indicated that the Board of Trustees granted full privileges to the Department of Pediatrics on 3/19/14.


The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences.

See 0341

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws, the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Hospital failed to maintain and effective quality assessment and performance improvement program.

Findings include:

1.) The Hospital failed to analyze (code) and track 4 written Maternity Incidents, MI's #1, #2, #3 and #4, as potential patient harm and failed to send the written reports to the Patient Safety Triage Team for review by physicians.

See 0273

2.) The Hospital failed to ensure that the performance improvement activities analyzed (coded) the 4 written MI's, so that the incidents were reviewed by physicians. The inaccurate coding lead to the continuation of unsafe practices in neonatal resuscitation.

See 0286

The failure of the Hospital to code the 4 written MI's, (MI ' s #1, #2, #3 and #4) as a "3P" that indicated a potential for patient harm, resulted in no communication to the Patient Safety Triage Team (PSTT) to review the 4 MI's. A potential for patient harm resulted in the continuation of issues with neonatal resuscitation without corrective action(s) by the Hospital.

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents (MI #1, #2, #3 and #4), the documents titled: Incident Severity Level, Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Hospital failed to analyze (code) and track MIs #1, #2, #3 and #4 as potential patient harm and send the 4 written Maternity Incidents (MI's #1, #2, #3 and #4) to the Patient Safety Triage Team for physician review.

Findings include:

The document titled Incident Severity Level, date not documented, indicated that a Severity Level categorized as "1" was a minor incident that resulted in no patient injury and a Severity Level categorized as a "3P" was a major incident that resulted in potential for patient harm.

Review of MI's #1, #2, #3 and #4, dated 2/22/14, 4/9/14 and 4/23/14 (2 reported) about neonatal resuscitation, indicated a final Incident Severity Code of "1" (minor incident that resulted in no patient injury). These reports were not sent to the Patient Safety Triage Team for medical review.

The document titled Triggers for Case Review, date not documented, did not indicate a trigger for potential patient harm.

The document titled Medical Staff Peer Review Process, date not documented, indicated that the Medical Staff would review written reports that were referred from the Patient Safety Triage Team.

The Surveyor interviewed the Vice President for Medical Affairs (VPMA, high-ranking Hospital executive, and Medical Doctor) #2 at 10:30 on 5/20/14. VPMA #2 said the documents titled Triggers for Case Review and Medical Staff Peer Review Process, outlined their robust peer review process. VPMA #2 said that a Risk Manager reviews all incident reports (IR) and sends all IR's categorized 3 or higher for review at the Patient Safety Triage Team (PSTT). VPMA #2 said that MI's #1, #2, #3 and #4 did not go to the PSTT for review until this week (5/19/14, during the survey).

The Surveyor interviewed the VPMA, CNO and Risk Manager at 8:30 A.M. on 5/16/14 and they did not describe a thorough Hospital internal investigation about the 4 Maternity Incidents described in MI's #1, #2, #3 or #4.

The failure of the Hospital to code MI's #1, #2, #3 and #4 as a potential for patient harm resulted in no trigger to the Patient Safety Triage Team to review MI's #1, #2, #3 and #4, therefore did not trigger a review by the Medical Staff Peer Review Process .

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents (MI #1, #2, #3 and #4), the document titled: Incident Severity Level and interviews, the Hospital performance improvement activities failed to send the MI's to the Patient Safety Triage Team (PSTT), which lead to the continuation of unsafe practices in neonatal resuscitation.

Findings include:

The document titled Incident Severity Level, date not documented, indicated that a Severity Level categorized as "1" was a minor incident that resulted in no patient injury and a Severity Level categorized as a "3P" was a major incident that resulted in potential for patient harm.

Review of MI's #1, #2, #3 and #4, dated 2/22/14, 4/9/14 and 4/23/14 (2 reported) about neonatal resuscitation, indicated these 4 incidents were minor, resulted in no patient injury and therefore were not sent for doctor review of neonatal resuscitation safe practices by the PSTT.

The Surveyor interviewed the Vice President for Medical Affairs (VPMA, high-ranking Hospital executive, and Medical Doctor) #2 at 10:30 on 5/20/14. VPMA #2 said that MI's #1, #2, #3 and #4 did not go to the PSTT for review until this week (5/19/14, during the survey).

The failure of the Hospital to send the 4 MI to the PSTT for doctor review resulted in the continuation of unsafe neonatal resuscitation practices, without corrective action(s) by the Hospital.

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incident [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws, the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Medical Staff failed to be responsible for the quality of medical care provided to patients by the Hospital.


1.) The Medical Staff failed to appraise Pediatrician #1's clinical competence to perform neonatal resuscitation skills prior to granting Membership to the Medical Staff and Medical Staff privileges.
See 0340

2.) The Medical Staff failed to ensure to the Governing Body that Pediatrician #1's Medical Staff privileges were not solely dependent on a current neonatal resuscitation training program.

See 0341


3.) The GB failed to assure that the Medical Staff was accountable to the GB for the quality of care provided to patients.

See 0347


4.) The Medical Staff failed to enforce their own Medical Staff Bylaws to carry out its responsibilities in evaluating Medical Staff membership performance.

See 0353

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4); review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)]; Medical Staff Bylaws and Policies; the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Medical Staff failed to appraise Pediatrician #1's demonstrated clinical competence to perform neonatal resuscitation skills prior to granting Membership to the Medical Staff and Medical Staff privileges.

Findings include:

The Medical Staff Bylaws policy titled: Focused Professional Practice Evaluation (FPPE), dated 4/2012, indicated each practitioner had his/her performance measured, monitored, evaluated and documented by the Chair of the Department and when a question arises regarding a practitioner's ability to provide safe and high quality patient care. The policy indicated that competence was evaluated through a process of proctoring, direct observation and peer review.

The document titled Triggers for Case Review, date not documented, did not indicate potential for patient harm as a trigger for Case Review.

The document titled Medical Staff Peer Review Process, date not documented, indicated that the Medical Staff would review written reports that were referred from the Patient Safety Triage Team.

The Surveyor interviewed the Vice President for Medical Affairs (VPMA, high-ranking Hospital executive and Medical Doctor) #2 at 10:30 on 5/20/14. VPMA #2 said that VPMA #1 reviewed MI's #1 and #2 that occurred on 2/22/14 and 4/9/14 respectively and determined that the Hospital needed to watch the situation. VPMA #2 said that VPMA #1 did not provide clinical counseling or develop corrective action(s) after Maternity Incident #1, #2 or #3. VPMA #2 said that VPMA #1 provided verbal counseling on 4/24/14 to Pediatrician #1 after MI #4 that occurred on 4/23/14. VPMA #2 said that the Hospital should have followed-up on the MI's but did not.

VPMA #2 said the documents titled Triggers for Case Review and Medical Staff Peer Review Process outlined their robust peer review process.

VPMA #2 said that a Hospital Risk Manager reviewed all MI's and sent those categorized as a "3" or higher for further medical review at the weekly Patient Safety Triage Team meeting. VPMA #2 said that the Hospital did not send MI's #1, #2, #3 and #4 to the Patient Safety Triage Team for review.

VPMA #2 said that MI #2 on 4/9/14 should have triggered a review by physicians but it was not sent for review. VPMA #2 said that the Medical Staff Quality Committee (MSQC, performs peer review) was unaware of the incidents and the MIs were not sent to the MSQC because they did not require peer review and they (risk management) did not believe that there was a breach in the standard of care. VPMA #2 said that MI's of 2/22/14, 4/9/14, 4/21/14 and 4/23/14 did not go to the Patient Safety Triage Team for review by physicians until this week (5/19/14, during the Survey) and this was late.

The Medical Staff was aware of 4 incidents involving Pediatrician #1 and did not develop corrective actions and did not provide a review by doctors of the MI's because the MI's were not sent for review. The failure to validate clinical competence, investigate the 4 MI's, have the 4 MI's reviewed by doctors and develop correction actions left newborn babies vulnerable to a practitioner lacking in neonatal resuscitation skills.

See A0041 and A0263

Based on review of and confirmed by interviews, the Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

From 2/22/14 through 4/23/14, Pediatrician #1 was involved in 4 births where she did not follow the standards of neonatal resuscitation.

The MI's that occurred on 2/22/14, 4/9/14, 4/21/14 and 4/23/14 indicated that Pediatrician #1 lacked skills in neonatal resuscitation, was not prepared for neonatal resuscitation at a high risk delivery, did not know how to use neonatal resuscitation equipment and did not know how to intubate (insert a breathing tube) a newborn

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that she interviewed Pediatrician #1 and Pediatrician #1 had completed the Neonatal Resuscitation Program (American Heart Association and American Academy of Pediatrics program on neonatal resuscitation) on 1/31/14.

The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences.

Review of Pediatrician #1's credentials file indicated that the application for temporary privileges that the Hospital granted 1/10/14 requested neonatal intubation privileges and the Board of Trustees granted her privileges to the Department of Pediatrics on 3/19/14.

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4);
review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)]; Medical Staff Bylaws; Hospital policies titled: Pediatrician Attendance at High Risk Delivery, Neonatal Resuscitation; documents titled: Neonatal Resuscitation Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Medical Staff failed to be accountable to the Governing Body (GB) for the quality of care provided to patients.

Findings include:

1.) The Medical Staff failed to appraise and be accountable to the GB and in evaluating the quality of care provided by Pediatrician #1 to Patients #1, #2, #3 and #4 after 4 written reports were submitted about Pediatrician #1's lack of demonstrated skills in newborn resuscitation.

Standards for Neonatal Resuscitation: Neonatal Resuscitation, 2010 American Heart Association (AHA)/American Academy of Pediatrics (AAP) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care indicated that anticipation, adequate preparation, accurate evaluation, and prompt initiation of support are critical for successful neonatal resuscitation. The guidelines indicated that at every delivery there should be at least 1 person who is promptly available with the skills required to perform endotracheal intubation.

From 2/22/14 through 4/23/14, Pediatrician #1 was involved in 4 births where she did not follow the standards of neonatal resuscitation.

The Hospital policy titled: Pediatrician Attendance at High Risk Delivery, dated 4/11/14, indicated that a pediatrician shall attend deliveries where meconium (First feces of a newborn infant, not normally present in amniotic fluid) was present in the amniotic fluid (fluid surrounding the baby in the womb) and at the request of the obstetrician.

The Hospital policy titled Neonatal Resuscitation; dated 2/18/08, 6/27/90, 5/15/14; indicated that a pediatrician would attend any delivery at the discretion of the obstetrician and the purpose of the policy was to ensure that providers would practice the latest evidence-based guidelines for neonatal resuscitation.

The document titled Triggers for Case Review, date not documented, did not indicate a reporting criteria for potential for patient harm.

The document titled Medical Staff Peer Review Process, date not documented, indicated that the Medical Staff would review Incident Reports that were referred from the Patient Safety Triage Team.

The document titled Incident Severity Level, date not documented, indicated that a Severity Level categorized as "1" was a minor incident that resulted in no patient injury and a Severity Level categorized as a "3P" was a major incident that resulted in potential for patient harm.

A.) Maternity Incident #1

Nursing Notes, dated 2/22/14 at 6:00 A.M. through 2/24/14 at 1:56 P.M., indicated Pediatrician #1 was present at the birth of Patient #1 because Patient #1 had passed meconium prior to the birth. Patient #1 required suctioning of the mouth, cried spontaneously at birth, and did not require resuscitation. The Nursing Notes indicated that Patient #1 did well during his/her hospitalization and was discharged home with his/her mother on 2/24/14.

Review of Maternity Incident #1, which occurred on 2/11/14, indicated that Pediatrician #1 did not wear gloves while caring for a newly born baby and did not verify that the suction and oxygen equipment necessary for the birth of a baby that potentially would need neonatal resuscitation was in good working condition.

The Surveyor interviewed the Interim Maternity Nurse Manager (NM) #1 at 8:30 A.M. on 5/15/14. NM #1 said that she provided Pediatrician #1 with the counseling about Standard or Universal Precautions (wearing gloves) when providing care to a newly born baby. NM #1 said that the Maternity Nurses were not confident with Pediatrician #1's skills in neonatal intubation. NM #1 said the maternity nurses told her Pediatrician #1 sat on a stool prior to the birth and did not check that the suction and oxygen equipment was in good working condition and did not wear gloves for the birth.

Preparation for a potentially sick newborn requiring neonatal resuscitation is an important first step and a neonatal resuscitation standard of care (American Academy of Pediatrics, Neonatal Resuscitation).

B.) Maternity Incident #2

The Nursing Notes, dated 4/9/14 at 11:25 P.M. through 4/14/14 at 1:30 P.M., indicated that Patient #2 was born by cesarean section for fetal intolerance to labor at 10:38 P.M. At birth, the infant was limp, pale and without a cry. The notes indicated Pediatrician #1 attempted to intubate the baby unsuccessfully and then attempted to suctioned the baby's mouth. The baby remained pale, limp, without a cry. A Registered Nurse suctioned Patient #2's airway, the baby coughed, cried and his/her color became pink. Patient #2 was discharged 4/14/14.

Review of Maternity Incident #2, which occurred on 4/9/14, indicated that Pediatrician #1 did not follow neonatal resuscitation standards of care. The report indicated that Pediatrician #1 did not wear gloves while caring for a newly born baby and was unable to intubate the baby to provide an airway and was not able to adequately suction the baby's airway.

C.) Maternity Incident #3

The Nursing Notes, dated 4/21/14 at 9:37 P.M. through 4/22/14 at 7:01 P.M., indicated that Patient #3 was born on 4/21/14 at 8:17 P.M. by cesarean section because maternal labor did not progress. The nursing notes indicated Patient #3 was born blue and limp, not moving and required resuscitation. The nursing notes indicated that by 9 minutes of life the baby had a normal heartbeat, spontaneously cried and Patient #3's color was pink.

The Progress Notes, dated 4/21/14 at 8:45 P.M. through 4/22/14 (time not documented), indicated that Anesthesiologist #2 intubated the Patient #3. The Progress Notes indicated that Patient #3's head had a cephalohematoma (bleeding between the baby's skull and bone from blood vessel rupture) and his/her head circumference had increased from 14 inches at birth to 15 inches. The Progress Notes indicated that Patient #3 was transported to a Neonatal Intensive Care Unit for further evaluation of a subgaleal hemorrhage [rare, potentially life threatening condition in newborns where the emissary veins, in the newborn's scalp (from prolonged pushing in labor) rupture. The entire newborn's blood volume can accumulate between the scalp and bone].

The Surveyor interviewed Registered Nurse (RN) #3 at 12:00 P.M. on 5/14/14. RN #2 said that Pediatrician #1 could not intubate the baby and that Anesthesiologist #2 intubated Patient #3. RN #3 said that generally a pediatrician inserts an intravenous line (IV), but she (RN #3) inserted the IV because Pediatrician #1 could not. RN #3 said that she expected Pediatrician #1 to be in charge (provide team members directions and orders) for resuscitating Patient #3, but she did not.

The Surveyor interviewed Registered Nurse (RN) #4 at 2:00 P.M. on 5/16/14. RN #4 said RN #6 told her (RN #4) that she (RN #6) asked Anesthesiologist #1 if he could intubate the baby if needed and Anesthesiologist #1 called Anesthesiologist #2 for assistance because RN #6 was not confident of Pediatrician #1's skills in newborn intubation. RN #4 said that Patient #3 required a full neonatal resuscitation and Pediatrician was "like a deer in headlights", and she, RN #4 and Anesthesiologist #2 resuscitated Patient #3. RN #3 said that Pediatrician #1 listened to Patient #3's heartbeat and did not "say a thing" (communicate to the resuscitation team the heartbeat according to AHA/AAP Neonatal Resuscitation Guidelines) and RN #4 assumed the responsibility of assessing the baby's heart beat. RN #4 said that Pediatrician #1 was providing the baby with artificial breathing using a resuscitation bag and was giving too much pressure with the resuscitation bag (not using the resuscitation equipment properly, too much pressure can cause serious lung injury to the newborn baby).

Review of Maternity Incident #3, that occurred on 4/21/14, indicated that Pediatrician #1 did not wear gloves, did not properly use neonatal resuscitation equipment, did not intubate Patient #3 (Patient #3 was intubated by an anesthesiologist) and did not assume the role of leading and directing the resuscitation. MI #3 indicated that Pediatrician #1 said that she was glad anesthesia physicians were present to intubate Patient #3 because she could not intubate the baby.

D.) Maternity Incident #4

Nursing Notes, dated 4/23/14 at 4:21 P.M. through 4/27/14 at 11:00 A.M., indicated that the Patient #4 was born by cesarean section for fetal intolerance to labor on 4/23/14 at 2:07 A.M. The nursing notes indicated Patient #4 was born limp with minimal movement and a heartbeat less than 100 beats per minute with an Apgar (system for evaluating an infant's condition at birth based on heart rate, respiration muscle tone and response to stimuli at birth, one minute and five minutes) score of 4 assigned by Pediatrician #1. Patient #4 required neonatal resuscitation including stimulation, suctioning of the mouth and throat and assistance with breathing using a resuscitation bag. The Nursing Notes indicated that the baby was doing well and had a normal heartbeat, spontaneously cried and had active movements by 10 minutes of life. The Nurses Notes indicated the Hospital discharged the baby home.

Review of MI #4, that occurred on 4/23/14, indicated that Pediatrician #1 did not properly use neonatal resuscitation equipment and did not accurately assign Patient #4's Apgar score.

The Surveyor interviewed RN #5 at 12:30 P.M. on 5/16/14. RN #5 said that Pediatrician #1 was requesting a non-premature handle (part of the intubation equipment) and she told Pediatrician #1 that the size of the intubation blade (part of the intubation equipment) not the handle was important, but Pediatrician #1 argued that she needed a non-premature handle. RN #5 said that she told Pediatrician #1 that Patient #4 had no chest rise (an indication of providing inadequate oxygen and no breaths to the baby) while Pediatrician #1 provided artificial breathing with the neonatal resuscitation bag and Pediatrician #1 said Patient #4 had an adequate chest rise. RN #5 said that she re-positioned the baby and then the baby had an adequate chest rise (an indication of adequate oxygenation and breaths to the baby). RN #5 said that the Apgar scores Pediatrician #1 assigned to Patient #4 were not accurate.

The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences, was having difficulty newborns and needed more experience with intubating newborns. Pediatrician #1 said that she spoke with VPMA #1 and the Hospital President last night about arranging experiences with newborn resuscitation but no plan was in place.

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that she received the electronic generated IR's when the IR's were generated. Pediatrician #1 was Neonatal Resuscitation (NRP, Neonatal Resuscitation Program) certified, was uncomfortable with the equipment in the delivery room and could "maybe" intubate a newly born baby. VPMA #1 said that she was going to have Pediatrician #1 work with an anesthesiologist at the Hospital or or another hospital to improve neonatal intubation skills, but the plan was not in place. VPMA #1 said Pediatrician #1 was counseled about Universal/Standard Precautions in the delivery of a baby (wearing gloves when providing care for a newly born). VPMA #1 said she counseled Pediatrician #1 about her responsibility as the team leader in a neonatal resuscitation. VPMA #1 said that the plan to have Pediatrician #1 improve her neonatal intubation skills by working with an anesthesiologist was not scheduled and that an anesthesiologist had told VPMA #1 that Pediatrician #1's skills in neonatal intubation were " not retrievable".

The Surveyor interviewed the Chief Nursing Officer (CNO, high ranking Hospital executive and Registered Nurse) at 10:30 A.M. on 5/15/15. The CNO said that she had concerns about Pediatrician #1 skills in neonatal intubation and recommended to VPMA #1 that Pediatrician #1 work with an anesthesiologist to improve her neonatal resuscitation skills.

The lack of preparation to resuscitate a newborn in the delivery room and provide a practitioner competent in the skill of neonatal intubation as indicated in the Maternity Incidents (MI) #1, #2, #3 and #4 regarding the births of Patients #1, #2, #3 and #4 was a potential risk for patient harm and injury to newly born babies.


2.) The Medical Staff failed to ensure that Neonatal Resuscitation Services were included in the Hospital policy for Resuscitation Services.

Findings include:

The Hospital policy titled: Neonatal Resuscitation, dated 5/15/14, indicated a reference to the Hospital policy titled, Resuscitation Services.

The Hospital policies titled: Resuscitation Services, dated 6/11/13 and Code Blue, dated 1/2013, indicated policy statements, procedures, needed equipment and emergency cart check lists for adult and pediatric emergencies. The policies did not indicate statements, procedures, needed equipment or emergency cart check list for neonatal resuscitation.

Based on review of the Medical Staff Bylaws and interview the Medical Staff failed to enforce their own Medical Staff Bylaws to carry out its responsibilities.

Findings include:

The Medical Staff Bylaws policy titled: Focused Professional Practice Evaluation (FPPE), dated 4/2012, indicated each practitioner had his/her performance measured, monitored, evaluated and documented by the Chair of the Department and again when a question arises regarding a practitioner's ability to provide safe and high quality patient care. The policy indicated that competence was evaluated through a process of proctoring, direct observation and peer review.

The Medical Staff Bylaws policy titled: Medical Staff Peer Review, dated 9/2011, indicated that the Medical Staff was accountable to the Hospital Governing Body (GB) for the quality of medical care provided to patients, through medical peer review committees that monitor professional practice of Medical Staff Members. The peer review process was designed to improve physician performance, promote and ensure a culture of excellence and safety. The medical peer review process was structured to identify incidents related to physician performance, code the incidents and provide evaluation of incidents. The policy indicated a hospital employee may communicate a physician concern to his/her supervisor, who would communicate the concern to the Vice President for Medical Affairs (VPMA) and or the Patient Safety Triage Team (PSTT, a medical peer review committee that reviews incidents).

The Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

The Medical Staff Bylaws Article #2 titled: Corrective Actions, dated 9/2011, indicated that the Medical Staff actively encourages any individual who was concerned about the professional practice of any individual Medical Staff Member to communicate the concern according to Hospital policy.

The Medical Staff Bylaws Article #10 titled: Patient Care Assessment Program (PCAP), dated 9/2011, indicated that the GB was responsible for a PCAP designed to provide effective quality assurance, risk management, peer review, identification and prevention of substandard practice by licensed health care professionals (for example: physicians and nurse practitioners). The Article indicated that any conduct by a licensed health care professional that is alleged to have incompetence in his/her specialty or to be inconsistent with or harmful to patient care, shall be reported to the PCAP Coordinator. The Article indicated that reports pertaining to medical Staff Members shall be investigated, reviewed and resolved in accordance with the procedures specified in the Medical Staff Bylaws.


The Medical Staff failed to meet it's responsiblities as per the medical staff bylaws by failing to:
1.) measure, monitor and evaluate Pediatrician #1's competency in neonatal resuscitation;
2.) identify incidents, as reported in Maternity Incidents (MI) #1, #2, #3 and #4, related to Pediatrician #1's performance and provide evaluation of those incidents, as reported in MI's #1, #2, #3 and #4;
3.) ensure Clinical Privileges included Pediatrician #1's competence in neonatal resuscitation and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on a current course in neonatal resuscitation;
4.) effectively act upon 4 MI's regarding the neonatal resuscitation skills of Pediatrician #1 and
5.) forward the 4 MI's to the PSTT for review, creating a potential situation at a birth, where a newborn would not be resuscitated according to the American Heart Association and American Academy of Pediatrics standards for neonatal resuscitation and potential for patient harm.


See A0340, A0341 and A0347

Based on review of Hospital policy titled: Competency Assessment, personnel file review and interview, the Nursing Service failed to ensure that the Interim Maternity Nurse Manager was educated in Electronic Fetal Monitoring (EFM).

Findings include:

Review of the job description titled: Clinical Manager, date not documented, indicated that the NM served as a professional role model and mentor to staff.

The Hospital policy titled, Competency Assessment, dated 5/2012, indicated that the person performing the assessment of competence must have adequate education, experience, or knowledge of the skill.

The Surveyor interviewed the Chief Nursing Officer (CNO, high-ranking hospital executive) and Interim Maternity Nurse Manager (NM) at 10:25 A.M. on 5/14/14. The CNO and NM said that the NM was not educated in Electronic Fetal Monitoring and that the Hospital had scheduled the NM to attend an EFM program in the autumn of 2014.

The NM would not be able to assess staff competency or mentor staff in EFM because she was not educated in Electronic Fetal Monitoring (EFM).

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws, the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Governing Body (GB) failed to be responsible for the conduct of the entire hospital.

Findings include:

1.) The GB failed to ensure that the Medical Staff appraised and was accountable to the GB, to evaluate the quality of care provided by Pediatrician #1 to Patients #1, #2, #3 and #4 after 4 MI's were submitted regarding Pediatrician #1's lack of skills in newborn resuscitation.

See 0049

2.) The GB failed to ensure that the Medical Staff used a procedure for applying the criteria for selection of Pediatrician #1, considered competent in providing skills neonatal resuscitation, included preparation and use of neonatal resuscitation equipment and neonatal intubation (inserting a breathing tube), prior to granting Medical Staff privileges.

See 0050

3.) The GB failed to ensure that Pediatrician #1's Medical Staff privileges were not granted, solely dependent on a current neonatal resuscitation training program.

See 0051 and 0341

4.) The GB failed to ensure that Hospital performance improvement activities analyzed (coded) and tracked the Maternity Incidents (MI) #1, #2, #3 and #4 as potential patient harm and sent MI's #1, #2, #3 and #4 to be reviewed by doctors.

See 0273

5.) The GB failed to ensure that the Hospital performance improvement activities analyzed the MI's which lead to the continuation of unsafe practices in neonatal resuscitation.

See 0286

6.) The GB failed to ensure that the Medical Staff appraised Pediatrician #1's clinical competence to perform neonatal resuscitation skills prior to granting Membership to the Medical Staff and Medical Staff privileges.

See 0340

7.) The GB failed to ensure that the Medical Staff ensured the Governing Body that Pediatrician #1's Medical Staff privileges were not solely dependent on a current neonatal resuscitation training program.

See 0341

8.) The GB failed to ensure that the Medical Staff was accountable to the GB for the quality of care provided to patients.

See 0347

9.) The GB failed to ensure that the Medical Staff enforced their own Medical Staff Bylaws to carry out its responsibilities to evaluate Pediatrician #1's competence through a process of proctoring, direct observation and peer review.

See 0353

10.) The GB failed to ensure that the Nursing Service ensured that the Interim Maternity Nurse Manager was educated in Electronic Fetal Monitoring.

See 0392

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4); review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)]; the documents titled: Neonatal Resuscitation Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and interviews, the Governing Body (GB) failed to ensure that the Medical Staff was accountable to the GB for the quality of care provided to patients.


Findings include:

1.) The GB failed to ensure that the Medical Staff appraised and was accountable to the GB in evaluating the quality of care provided by Pediatrician #1 to Patients #1, #2, #3 and #4 after 4 MI's were submitted about Pediatrician #1's lack of demonstrated skills in newborn resuscitation.


Neonatal Resuscitation, 2010 American Heart Association (AHA)/American Academy of Pediatrics (AAP) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care indicated that anticipation, adequate preparation, accurate evaluation, and prompt initiation of support are critical for successful neonatal resuscitation. At every delivery there should be at least 1 person who is promptly available with the skills required to perform endotracheal intubation.

From 2/22/14 through 4/23/14, Pediatrician #1 was involved in 4 births where she did not follow the standards of neonatal resuscitation.

The MI's that occurred on 2/22/14, 4/9/14, 4/21/14 and 4/23/14 indicated that Pediatrician #1 lacked skills in neonatal resuscitation, was not prepared for neonatal resuscitation at a high risk delivery, did not know how to use neonatal resuscitation equipment and did not know how to intubate a newborn (insert a breathing tube).

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that she received the electronic generated MI's when the MI's were generated. VPMA #1 said Pediatrician #1 was Neonatal Resuscitation (NRP, Neonatal Resuscitation Program) certified, was uncomfortable with the equipment in the delivery room and could "maybe" intubate a newly born baby.

VPMA #1 said an anesthesiologist was not necessarily a resource for neonatal intubation. VPMA #1 said she was going to have Pediatrician #1 work with an anesthesiologist at the Hospital or another hospital to improve neonatal intubation skills but the plan was not in place.

VPMA #1 said Pediatrician #1 was counseled about Universal Precautions in the delivery of a baby (wearing gloves when providing care for a newborn). VPMA #1 said she counseled Pediatrician #1 about her responsibility as the team leader in a neonatal resuscitation. VPMA #1 said a plan to have Pediatrician #1 improve her neonatal intubation skills by working with an anesthesiologist was not scheduled and that the Chief of the Anesthesiology Department told her that Pediatrician #1's skills in neonatal intubation were "not retrievable".

Although VPMA #1 was aware of each incident, she told the Maternity Nurse Manager to counsel Pediatrician #1 about wearing gloves at a delivery and did not personally have a conversation with Pediatrician #1 after MI #1 or take corrective action(s). VPMA #1 said she did not have a conversation with Pediatrician #1 after MI #2, which occurred on 4/9/14, until 4/24/14. Two other incidents occurred after 4/9/14, MIs, #3 and MI #4 which were not discussed on 4/24/14. A corrective action plan was not developed, therefore leaving newborns in the care of Pediatrician #1 at risk of serious harm to health and safety.

See 0347

Based on review of the Medical Staff Bylaw, review of Maternity Incidents (MIs ##1) credential file review for Pediatrician #1 and interviews, the GB failed to ensure that the Medical Staff used a procedure for applying the criteria for selection of Pediatrician #1, including competence in neonatal resuscitation, prior to granting Medical Staff privileges.

Findings include:

The Medical Staff Bylaws policy titled: Focused Professional Practice Evaluation (FPPE), dated 4/2012, indicated each practitioner had his/her performance measured, monitored, evaluated and documented by the Chair of the Department and when a question arises regarding a practitioner's ability to provide safe and high quality patient care. The policy indicated that the Medical Staff evaluated Medical Staff competence through a process of proctoring, direct observation and peer review.

The Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

Maternity Incident (MI) #1 that occurred on 2/22/14 indicated that Pediatrician #1 did not wear gloves while caring for a newly born baby and was not prepared for neonatal resuscitation at a high-risk delivery.

Review of Pediatrician #1's credentials indicated that she requested intubation privileges and the Board of Trustees granted her full staff privileges to the Department of Pediatrics on 3/19/14.

The Medical Staff was aware of the 4 MI's (2/22/14, 4/9/14, 4/21/14 and 4/23/14) involving Pediatrician #1 and did not measure, monitor or evaluate her performance, according to their own Bylaws.

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high-ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that Pediatrician #1 had completed the Neonatal Resuscitation Program (American Heart Association and American Academy of Pediatrics program on neonatal resuscitation) on 1/31/14.

The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences.

The failure to validate clinical competence left newborn babies vulnerable to a practitioner lacking in neonatal resuscitation skills.

See 0340 and 0341

Based on review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws and interviews, the Medical Staff failed to assure the Governing Body (GB) that Pediatrician #1's Medical Staff privileges in the Hospital were not solely dependent on a current neonatal resuscitation training program.

Findings include:

The Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M., 1:00 P.M. and 3:30 on 5/15/14. VPMA #1 said that Pediatrician #1 completed the Neonatal Resuscitation Program (American Heart Association and American Academy of Pediatrics program) on neonatal resuscitation) on 1/31/14 and Pediatrician #1 was granted temporary privileges on 1/10/14.

Review of Pediatrician #1's credentials indicated that the Board of Trustees granted full privileges to the Department of Pediatrics on 3/19/14.


The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences.

See 0341

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws, the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Hospital failed to maintain and effective quality assessment and performance improvement program.

Findings include:

1.) The Hospital failed to analyze (code) and track 4 written Maternity Incidents, MI's #1, #2, #3 and #4, as potential patient harm and failed to send the written reports to the Patient Safety Triage Team for review by physicians.

See 0273

2.) The Hospital failed to ensure that the performance improvement activities analyzed (coded) the 4 written MI's, so that the incidents were reviewed by physicians. The inaccurate coding lead to the continuation of unsafe practices in neonatal resuscitation.

See 0286

The failure of the Hospital to code the 4 written MI's, (MI ' s #1, #2, #3 and #4) as a "3P" that indicated a potential for patient harm, resulted in no communication to the Patient Safety Triage Team (PSTT) to review the 4 MI's. A potential for patient harm resulted in the continuation of issues with neonatal resuscitation without corrective action(s) by the Hospital.

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents (MI #1, #2, #3 and #4), the documents titled: Incident Severity Level, Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Hospital failed to analyze (code) and track MIs #1, #2, #3 and #4 as potential patient harm and send the 4 written Maternity Incidents (MI's #1, #2, #3 and #4) to the Patient Safety Triage Team for physician review.

Findings include:

The document titled Incident Severity Level, date not documented, indicated that a Severity Level categorized as "1" was a minor incident that resulted in no patient injury and a Severity Level categorized as a "3P" was a major incident that resulted in potential for patient harm.

Review of MI's #1, #2, #3 and #4, dated 2/22/14, 4/9/14 and 4/23/14 (2 reported) about neonatal resuscitation, indicated a final Incident Severity Code of "1" (minor incident that resulted in no patient injury). These reports were not sent to the Patient Safety Triage Team for medical review.

The document titled Triggers for Case Review, date not documented, did not indicate a trigger for potential patient harm.

The document titled Medical Staff Peer Review Process, date not documented, indicated that the Medical Staff would review written reports that were referred from the Patient Safety Triage Team.

The Surveyor interviewed the Vice President for Medical Affairs (VPMA, high-ranking Hospital executive, and Medical Doctor) #2 at 10:30 on 5/20/14. VPMA #2 said the documents titled Triggers for Case Review and Medical Staff Peer Review Process, outlined their robust peer review process. VPMA #2 said that a Risk Manager reviews all incident reports (IR) and sends all IR's categorized 3 or higher for review at the Patient Safety Triage Team (PSTT). VPMA #2 said that MI's #1, #2, #3 and #4 did not go to the PSTT for review until this week (5/19/14, during the survey).

The Surveyor interviewed the VPMA, CNO and Risk Manager at 8:30 A.M. on 5/16/14 and they did not describe a thorough Hospital internal investigation about the 4 Maternity Incidents described in MI's #1, #2, #3 or #4.

The failure of the Hospital to code MI's #1, #2, #3 and #4 as a potential for patient harm resulted in no trigger to the Patient Safety Triage Team to review MI's #1, #2, #3 and #4, therefore did not trigger a review by the Medical Staff Peer Review Process .

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incidents (MI #1, #2, #3 and #4), the document titled: Incident Severity Level and interviews, the Hospital performance improvement activities failed to send the MI's to the Patient Safety Triage Team (PSTT), which lead to the continuation of unsafe practices in neonatal resuscitation.

Findings include:

The document titled Incident Severity Level, date not documented, indicated that a Severity Level categorized as "1" was a minor incident that resulted in no patient injury and a Severity Level categorized as a "3P" was a major incident that resulted in potential for patient harm.

Review of MI's #1, #2, #3 and #4, dated 2/22/14, 4/9/14 and 4/23/14 (2 reported) about neonatal resuscitation, indicated these 4 incidents were minor, resulted in no patient injury and therefore were not sent for doctor review of neonatal resuscitation safe practices by the PSTT.

The Surveyor interviewed the Vice President for Medical Affairs (VPMA, high-ranking Hospital executive, and Medical Doctor) #2 at 10:30 on 5/20/14. VPMA #2 said that MI's #1, #2, #3 and #4 did not go to the PSTT for review until this week (5/19/14, during the survey).

The failure of the Hospital to send the 4 MI to the PSTT for doctor review resulted in the continuation of unsafe neonatal resuscitation practices, without corrective action(s) by the Hospital.

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4), review of 4 of 21 Maternity Incident [(MI) #1, #2, #3 and #4)], Medical Staff Bylaws, the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Medical Staff failed to be responsible for the quality of medical care provided to patients by the Hospital.


1.) The Medical Staff failed to appraise Pediatrician #1's clinical competence to perform neonatal resuscitation skills prior to granting Membership to the Medical Staff and Medical Staff privileges.
See 0340

2.) The Medical Staff failed to ensure to the Governing Body that Pediatrician #1's Medical Staff privileges were not solely dependent on a current neonatal resuscitation training program.

See 0341


3.) The GB failed to assure that the Medical Staff was accountable to the GB for the quality of care provided to patients.

See 0347


4.) The Medical Staff failed to enforce their own Medical Staff Bylaws to carry out its responsibilities in evaluating Medical Staff membership performance.

See 0353

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4); review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)]; Medical Staff Bylaws and Policies; the documents titled: Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Medical Staff failed to appraise Pediatrician #1's demonstrated clinical competence to perform neonatal resuscitation skills prior to granting Membership to the Medical Staff and Medical Staff privileges.

Findings include:

The Medical Staff Bylaws policy titled: Focused Professional Practice Evaluation (FPPE), dated 4/2012, indicated each practitioner had his/her performance measured, monitored, evaluated and documented by the Chair of the Department and when a question arises regarding a practitioner's ability to provide safe and high quality patient care. The policy indicated that competence was evaluated through a process of proctoring, direct observation and peer review.

The document titled Triggers for Case Review, date not documented, did not indicate potential for patient harm as a trigger for Case Review.

The document titled Medical Staff Peer Review Process, date not documented, indicated that the Medical Staff would review written reports that were referred from the Patient Safety Triage Team.

The Surveyor interviewed the Vice President for Medical Affairs (VPMA, high-ranking Hospital executive and Medical Doctor) #2 at 10:30 on 5/20/14. VPMA #2 said that VPMA #1 reviewed MI's #1 and #2 that occurred on 2/22/14 and 4/9/14 respectively and determined that the Hospital needed to watch the situation. VPMA #2 said that VPMA #1 did not provide clinical counseling or develop corrective action(s) after Maternity Incident #1, #2 or #3. VPMA #2 said that VPMA #1 provided verbal counseling on 4/24/14 to Pediatrician #1 after MI #4 that occurred on 4/23/14. VPMA #2 said that the Hospital should have followed-up on the MI's but did not.

VPMA #2 said the documents titled Triggers for Case Review and Medical Staff Peer Review Process outlined their robust peer review process.

VPMA #2 said that a Hospital Risk Manager reviewed all MI's and sent those categorized as a "3" or higher for further medical review at the weekly Patient Safety Triage Team meeting. VPMA #2 said that the Hospital did not send MI's #1, #2, #3 and #4 to the Patient Safety Triage Team for review.

VPMA #2 said that MI #2 on 4/9/14 should have triggered a review by physicians but it was not sent for review. VPMA #2 said that the Medical Staff Quality Committee (MSQC, performs peer review) was unaware of the incidents and the MIs were not sent to the MSQC because they did not require peer review and they (risk management) did not believe that there was a breach in the standard of care. VPMA #2 said that MI's of 2/22/14, 4/9/14, 4/21/14 and 4/23/14 did not go to the Patient Safety Triage Team for review by physicians until this week (5/19/14, during the Survey) and this was late.

The Medical Staff was aware of 4 incidents involving Pediatrician #1 and did not develop corrective actions and did not provide a review by doctors of the MI's because the MI's were not sent for review. The failure to validate clinical competence, investigate the 4 MI's, have the 4 MI's reviewed by doctors and develop correction actions left newborn babies vulnerable to a practitioner lacking in neonatal resuscitation skills.

See A0041 and A0263

Based on review of and confirmed by interviews, the Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

From 2/22/14 through 4/23/14, Pediatrician #1 was involved in 4 births where she did not follow the standards of neonatal resuscitation.

The MI's that occurred on 2/22/14, 4/9/14, 4/21/14 and 4/23/14 indicated that Pediatrician #1 lacked skills in neonatal resuscitation, was not prepared for neonatal resuscitation at a high risk delivery, did not know how to use neonatal resuscitation equipment and did not know how to intubate (insert a breathing tube) a newborn

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that she interviewed Pediatrician #1 and Pediatrician #1 had completed the Neonatal Resuscitation Program (American Heart Association and American Academy of Pediatrics program on neonatal resuscitation) on 1/31/14.

The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences.

Review of Pediatrician #1's credentials file indicated that the application for temporary privileges that the Hospital granted 1/10/14 requested neonatal intubation privileges and the Board of Trustees granted her privileges to the Department of Pediatrics on 3/19/14.

Based on review of 4 of 11 sampled patients (Patients #1, #2, #3 and #4);
review of 4 of 21 Maternity Incidents [(MI) #1, #2, #3 and #4)]; Medical Staff Bylaws; Hospital policies titled: Pediatrician Attendance at High Risk Delivery, Neonatal Resuscitation; documents titled: Neonatal Resuscitation Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Triggers for Case Review and Medical Staff Peer Review Process and interviews, the Medical Staff failed to be accountable to the Governing Body (GB) for the quality of care provided to patients.

Findings include:

1.) The Medical Staff failed to appraise and be accountable to the GB and in evaluating the quality of care provided by Pediatrician #1 to Patients #1, #2, #3 and #4 after 4 written reports were submitted about Pediatrician #1's lack of demonstrated skills in newborn resuscitation.

Standards for Neonatal Resuscitation: Neonatal Resuscitation, 2010 American Heart Association (AHA)/American Academy of Pediatrics (AAP) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care indicated that anticipation, adequate preparation, accurate evaluation, and prompt initiation of support are critical for successful neonatal resuscitation. The guidelines indicated that at every delivery there should be at least 1 person who is promptly available with the skills required to perform endotracheal intubation.

From 2/22/14 through 4/23/14, Pediatrician #1 was involved in 4 births where she did not follow the standards of neonatal resuscitation.

The Hospital policy titled: Pediatrician Attendance at High Risk Delivery, dated 4/11/14, indicated that a pediatrician shall attend deliveries where meconium (First feces of a newborn infant, not normally present in amniotic fluid) was present in the amniotic fluid (fluid surrounding the baby in the womb) and at the request of the obstetrician.

The Hospital policy titled Neonatal Resuscitation; dated 2/18/08, 6/27/90, 5/15/14; indicated that a pediatrician would attend any delivery at the discretion of the obstetrician and the purpose of the policy was to ensure that providers would practice the latest evidence-based guidelines for neonatal resuscitation.

The document titled Triggers for Case Review, date not documented, did not indicate a reporting criteria for potential for patient harm.

The document titled Medical Staff Peer Review Process, date not documented, indicated that the Medical Staff would review Incident Reports that were referred from the Patient Safety Triage Team.

The document titled Incident Severity Level, date not documented, indicated that a Severity Level categorized as "1" was a minor incident that resulted in no patient injury and a Severity Level categorized as a "3P" was a major incident that resulted in potential for patient harm.

A.) Maternity Incident #1

Nursing Notes, dated 2/22/14 at 6:00 A.M. through 2/24/14 at 1:56 P.M., indicated Pediatrician #1 was present at the birth of Patient #1 because Patient #1 had passed meconium prior to the birth. Patient #1 required suctioning of the mouth, cried spontaneously at birth, and did not require resuscitation. The Nursing Notes indicated that Patient #1 did well during his/her hospitalization and was discharged home with his/her mother on 2/24/14.

Review of Maternity Incident #1, which occurred on 2/11/14, indicated that Pediatrician #1 did not wear gloves while caring for a newly born baby and did not verify that the suction and oxygen equipment necessary for the birth of a baby that potentially would need neonatal resuscitation was in good working condition.

The Surveyor interviewed the Interim Maternity Nurse Manager (NM) #1 at 8:30 A.M. on 5/15/14. NM #1 said that she provided Pediatrician #1 with the counseling about Standard or Universal Precautions (wearing gloves) when providing care to a newly born baby. NM #1 said that the Maternity Nurses were not confident with Pediatrician #1's skills in neonatal intubation. NM #1 said the maternity nurses told her Pediatrician #1 sat on a stool prior to the birth and did not check that the suction and oxygen equipment was in good working condition and did not wear gloves for the birth.

Preparation for a potentially sick newborn requiring neonatal resuscitation is an important first step and a neonatal resuscitation standard of care (American Academy of Pediatrics, Neonatal Resuscitation).

B.) Maternity Incident #2

The Nursing Notes, dated 4/9/14 at 11:25 P.M. through 4/14/14 at 1:30 P.M., indicated that Patient #2 was born by cesarean section for fetal intolerance to labor at 10:38 P.M. At birth, the infant was limp, pale and without a cry. The notes indicated Pediatrician #1 attempted to intubate the baby unsuccessfully and then attempted to suctioned the baby's mouth. The baby remained pale, limp, without a cry. A Registered Nurse suctioned Patient #2's airway, the baby coughed, cried and his/her color became pink. Patient #2 was discharged 4/14/14.

Review of Maternity Incident #2, which occurred on 4/9/14, indicated that Pediatrician #1 did not follow neonatal resuscitation standards of care. The report indicated that Pediatrician #1 did not wear gloves while caring for a newly born baby and was unable to intubate the baby to provide an airway and was not able to adequately suction the baby's airway.

C.) Maternity Incident #3

The Nursing Notes, dated 4/21/14 at 9:37 P.M. through 4/22/14 at 7:01 P.M., indicated that Patient #3 was born on 4/21/14 at 8:17 P.M. by cesarean section because maternal labor did not progress. The nursing notes indicated Patient #3 was born blue and limp, not moving and required resuscitation. The nursing notes indicated that by 9 minutes of life the baby had a normal heartbeat, spontaneously cried and Patient #3's color was pink.

The Progress Notes, dated 4/21/14 at 8:45 P.M. through 4/22/14 (time not documented), indicated that Anesthesiologist #2 intubated the Patient #3. The Progress Notes indicated that Patient #3's head had a cephalohematoma (bleeding between the baby's skull and bone from blood vessel rupture) and his/her head circumference had increased from 14 inches at birth to 15 inches. The Progress Notes indicated that Patient #3 was transported to a Neonatal Intensive Care Unit for further evaluation of a subgaleal hemorrhage [rare, potentially life threatening condition in newborns where the emissary veins, in the newborn's scalp (from prolonged pushing in labor) rupture. The entire newborn's blood volume can accumulate between the scalp and bone].

The Surveyor interviewed Registered Nurse (RN) #3 at 12:00 P.M. on 5/14/14. RN #2 said that Pediatrician #1 could not intubate the baby and that Anesthesiologist #2 intubated Patient #3. RN #3 said that generally a pediatrician inserts an intravenous line (IV), but she (RN #3) inserted the IV because Pediatrician #1 could not. RN #3 said that she expected Pediatrician #1 to be in charge (provide team members directions and orders) for resuscitating Patient #3, but she did not.

The Surveyor interviewed Registered Nurse (RN) #4 at 2:00 P.M. on 5/16/14. RN #4 said RN #6 told her (RN #4) that she (RN #6) asked Anesthesiologist #1 if he could intubate the baby if needed and Anesthesiologist #1 called Anesthesiologist #2 for assistance because RN #6 was not confident of Pediatrician #1's skills in newborn intubation. RN #4 said that Patient #3 required a full neonatal resuscitation and Pediatrician was "like a deer in headlights", and she, RN #4 and Anesthesiologist #2 resuscitated Patient #3. RN #3 said that Pediatrician #1 listened to Patient #3's heartbeat and did not "say a thing" (communicate to the resuscitation team the heartbeat according to AHA/AAP Neonatal Resuscitation Guidelines) and RN #4 assumed the responsibility of assessing the baby's heart beat. RN #4 said that Pediatrician #1 was providing the baby with artificial breathing using a resuscitation bag and was giving too much pressure with the resuscitation bag (not using the resuscitation equipment properly, too much pressure can cause serious lung injury to the newborn baby).

Review of Maternity Incident #3, that occurred on 4/21/14, indicated that Pediatrician #1 did not wear gloves, did not properly use neonatal resuscitation equipment, did not intubate Patient #3 (Patient #3 was intubated by an anesthesiologist) and did not assume the role of leading and directing the resuscitation. MI #3 indicated that Pediatrician #1 said that she was glad anesthesia physicians were present to intubate Patient #3 because she could not intubate the baby.

D.) Maternity Incident #4

Nursing Notes, dated 4/23/14 at 4:21 P.M. through 4/27/14 at 11:00 A.M., indicated that the Patient #4 was born by cesarean section for fetal intolerance to labor on 4/23/14 at 2:07 A.M. The nursing notes indicated Patient #4 was born limp with minimal movement and a heartbeat less than 100 beats per minute with an Apgar (system for evaluating an infant's condition at birth based on heart rate, respiration muscle tone and response to stimuli at birth, one minute and five minutes) score of 4 assigned by Pediatrician #1. Patient #4 required neonatal resuscitation including stimulation, suctioning of the mouth and throat and assistance with breathing using a resuscitation bag. The Nursing Notes indicated that the baby was doing well and had a normal heartbeat, spontaneously cried and had active movements by 10 minutes of life. The Nurses Notes indicated the Hospital discharged the baby home.

Review of MI #4, that occurred on 4/23/14, indicated that Pediatrician #1 did not properly use neonatal resuscitation equipment and did not accurately assign Patient #4's Apgar score.

The Surveyor interviewed RN #5 at 12:30 P.M. on 5/16/14. RN #5 said that Pediatrician #1 was requesting a non-premature handle (part of the intubation equipment) and she told Pediatrician #1 that the size of the intubation blade (part of the intubation equipment) not the handle was important, but Pediatrician #1 argued that she needed a non-premature handle. RN #5 said that she told Pediatrician #1 that Patient #4 had no chest rise (an indication of providing inadequate oxygen and no breaths to the baby) while Pediatrician #1 provided artificial breathing with the neonatal resuscitation bag and Pediatrician #1 said Patient #4 had an adequate chest rise. RN #5 said that she re-positioned the baby and then the baby had an adequate chest rise (an indication of adequate oxygenation and breaths to the baby). RN #5 said that the Apgar scores Pediatrician #1 assigned to Patient #4 were not accurate.

The Surveyor interviewed Pediatrician #1 at 11:45 A.M. on 5/16/14. Pediatrician #1 said that she rarely intubated newborns in her past experiences, was having difficulty newborns and needed more experience with intubating newborns. Pediatrician #1 said that she spoke with VPMA #1 and the Hospital President last night about arranging experiences with newborn resuscitation but no plan was in place.

The Surveyor interviewed the Hospital's Vice President for Medical Affaires #1 (VPMA, a high ranking Member of the Medical Staff, Hospital executive and Medical Doctor) at 11:45 A.M. on 5/14/14, at 8:00 A.M. on 5/15/14 and at 1:00 P.M. on 5/15/14. VPMA #1 said that she received the electronic generated IR's when the IR's were generated. Pediatrician #1 was Neonatal Resuscitation (NRP, Neonatal Resuscitation Program) certified, was uncomfortable with the equipment in the delivery room and could "maybe" intubate a newly born baby. VPMA #1 said that she was going to have Pediatrician #1 work with an anesthesiologist at the Hospital or or another hospital to improve neonatal intubation skills, but the plan was not in place. VPMA #1 said Pediatrician #1 was counseled about Universal/Standard Precautions in the delivery of a baby (wearing gloves when providing care for a newly born). VPMA #1 said she counseled Pediatrician #1 about her responsibility as the team leader in a neonatal resuscitation. VPMA #1 said that the plan to have Pediatrician #1 improve her neonatal intubation skills by working with an anesthesiologist was not scheduled and that an anesthesiologist had told VPMA #1 that Pediatrician #1's skills in neonatal intubation were " not retrievable".

The Surveyor interviewed the Chief Nursing Officer (CNO, high ranking Hospital executive and Registered Nurse) at 10:30 A.M. on 5/15/15. The CNO said that she had concerns about Pediatrician #1 skills in neonatal intubation and recommended to VPMA #1 that Pediatrician #1 work with an anesthesiologist to improve her neonatal resuscitation skills.

The lack of preparation to resuscitate a newborn in the delivery room and provide a practitioner competent in the skill of neonatal intubation as indicated in the Maternity Incidents (MI) #1, #2, #3 and #4 regarding the births of Patients #1, #2, #3 and #4 was a potential risk for patient harm and injury to newly born babies.


2.) The Medical Staff failed to ensure that Neonatal Resuscitation Services were included in the Hospital policy for Resuscitation Services.

Findings include:

The Hospital policy titled: Neonatal Resuscitation, dated 5/15/14, indicated a reference to the Hospital policy titled, Resuscitation Services.

The Hospital policies titled: Resuscitation Services, dated 6/11/13 and Code Blue, dated 1/2013, indicated policy statements, procedures, needed equipment and emergency cart check lists for adult and pediatric emergencies. The policies did not indicate statements, procedures, needed equipment or emergency cart check list for neonatal resuscitation.

Based on review of the Medical Staff Bylaws and interview the Medical Staff failed to enforce their own Medical Staff Bylaws to carry out its responsibilities.

Findings include:

The Medical Staff Bylaws policy titled: Focused Professional Practice Evaluation (FPPE), dated 4/2012, indicated each practitioner had his/her performance measured, monitored, evaluated and documented by the Chair of the Department and again when a question arises regarding a practitioner's ability to provide safe and high quality patient care. The policy indicated that competence was evaluated through a process of proctoring, direct observation and peer review.

The Medical Staff Bylaws policy titled: Medical Staff Peer Review, dated 9/2011, indicated that the Medical Staff was accountable to the Hospital Governing Body (GB) for the quality of medical care provided to patients, through medical peer review committees that monitor professional practice of Medical Staff Members. The peer review process was designed to improve physician performance, promote and ensure a culture of excellence and safety. The medical peer review process was structured to identify incidents related to physician performance, code the incidents and provide evaluation of incidents. The policy indicated a hospital employee may communicate a physician concern to his/her supervisor, who would communicate the concern to the Vice President for Medical Affairs (VPMA) and or the Patient Safety Triage Team (PSTT, a medical peer review committee that reviews incidents).

The Medical Staff Bylaws Article #1 titled: Name, Purposes and Responsibilities, dated 9/2011, indicated that the GB ensured that the criteria for Medical Staff Membership and Clinical Privileges included competence and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on certification.

The Medical Staff Bylaws Article #2 titled: Corrective Actions, dated 9/2011, indicated that the Medical Staff actively encourages any individual who was concerned about the professional practice of any individual Medical Staff Member to communicate the concern according to Hospital policy.

The Medical Staff Bylaws Article #10 titled: Patient Care Assessment Program (PCAP), dated 9/2011, indicated that the GB was responsible for a PCAP designed to provide effective quality assurance, risk management, peer review, identification and prevention of substandard practice by licensed health care professionals (for example: physicians and nurse practitioners). The Article indicated that any conduct by a licensed health care professional that is alleged to have incompetence in his/her specialty or to be inconsistent with or harmful to patient care, shall be reported to the PCAP Coordinator. The Article indicated that reports pertaining to medical Staff Members shall be investigated, reviewed and resolved in accordance with the procedures specified in the Medical Staff Bylaws.


The Medical Staff failed to meet it's responsiblities as per the medical staff bylaws by failing to:
1.) measure, monitor and evaluate Pediatrician #1's competency in neonatal resuscitation;
2.) identify incidents, as reported in Maternity Incidents (MI) #1, #2, #3 and #4, related to Pediatrician #1's performance and provide evaluation of those incidents, as reported in MI's #1, #2, #3 and #4;
3.) ensure Clinical Privileges included Pediatrician #1's competence in neonatal resuscitation and ensured that under no circumstances would Medical Staff Membership and Clinical Privileges be granted solely on a current course in neonatal resuscitation;
4.) effectively act upon 4 MI's regarding the neonatal resuscitation skills of Pediatrician #1 and
5.) forward the 4 MI's to the PSTT for review, creating a potential situation at a birth, where a newborn would not be resuscitated according to the American Heart Association and American Academy of Pediatrics standards for neonatal resuscitation and potential for patient harm.


See A0340, A0341 and A0347

Based on review of Hospital policy titled: Competency Assessment, personnel file review and interview, the Nursing Service failed to ensure that the Interim Maternity Nurse Manager was educated in Electronic Fetal Monitoring (EFM).

Findings include:

Review of the job description titled: Clinical Manager, date not documented, indicated that the NM served as a professional role model and mentor to staff.

The Hospital policy titled, Competency Assessment, dated 5/2012, indicated that the person performing the assessment of competence must have adequate education, experience, or knowledge of the skill.

The Surveyor interviewed the Chief Nursing Officer (CNO, high-ranking hospital executive) and Interim Maternity Nurse Manager (NM) at 10:25 A.M. on 5/14/14. The CNO and NM said that the NM was not educated in Electronic Fetal Monitoring and that the Hospital had scheduled the NM to attend an EFM program in the autumn of 2014.

The NM would not be able to assess staff competency or mentor staff in EFM because she was not educated in Electronic Fetal Monitoring (EFM).