HospitalInspections.org

The Hospital was out of compliance with the Governing Body Condition of Participation.

Findings include:

1.) The Governing Body failed to ensure Obstetrics and Family Medicine Physicians who deliver obstetric care/services provided quality care to patients in accordance with clearly defined criteria, terminology and scope of practice was outlined in Medical Staff Bylaws for obstetric privileges granted by the Governing Body.

Refer to TAG: A-0049.

2.) The Governing Body failed for six (Patients #1, #2, #3, #5, #6, & #8) of eleven sampled patients to ensure investigations of adverse obstetric patient events were thorough and timely, that corrective actions were implemented and monitored (audited) for compliance and that expert medical reviews were conducted as appropriate.

Refer to TAG: A-0057.

Based on records reviewed and interviews, the Governing Body failed to ensure Obstetrics and Family Medicine Physicians who deliver obstetric care/services provided quality care to patients in accordance with clearly defined criteria, terminology and scope of practice was outlined in Medical Staff Bylaws for obstetric privileges granted by the Governing Body.

Findings include:

1.) Regarding the failure of the Governing Body to ensure the Medical Staff was responsible and accountable to identify a clear definition of a high-risk pregnancy for both the Obstetrics and Family Medicine Departments that deliver obstetric care at the Hospital:

The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Family Medicine Consultation Escalation Policy described the criterion to identify a high-risk obstetric patient.

The policy titled, Family Medicine Consultation Escalation Policy, dated 8/8/18, indicated criteria for when a Family Medicine Physician without Advanced Obstetric Privileges consulted with a Family Medicine Physician with Advanced Obstetric Privileges and when they consulted with an Obstetrician. The Family Medicine Consultation Escalation Policy did not indicate a Hospital policy with clear criteria that identified high-risk obstetric patients effective for all providers and disciplines (Medicine, Nursing, and Respiratory Care) that cared for obstetric Hospital patients.

The Hospital provided no documentation to indicate a clear definition of the Hospital's definition of a high-risk obstetric patient.

2.) Regarding the failure of the Governing Body to ensure the Medical Staff was responsible and accountable for clearly defined scopes of obstetric practice in the Medical Staff Bylaws and Rules and Regulations:

The Medical Staff Bylaws, dated 6/14/16, indicated no clearly defined scopes of obstetric practice for a Family Medicine Provider with Advanced Obstetric Privileges that the Governing Body credentialed and privileged to provide care for high-risk obstetric Hospital patients.

The Surveyor interviewed the Chief of Family Medicine, at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said the Family Medicine Department included Family Medicine Physicians with obstetric credentials that the Hospital privileged to be allowed to deliver babies at the Hospital. The Chief of Family Medicine said that the Family Medicine Department included Family Medicine Physicians credentialed with Advanced Obstetric Privileges to care for high-risk obstetric mothers. The Chief of Family Medicine said that the Family Medicine literature (books and writings published on a particular subject) identified Family Medicine Providers that care for high-risk obstetric patients as having Advanced Obstetric Privileges.

The Privileges Request form indicated Family Medicine Providers that care for high-risk obstetric patients have Extended Obstetric Privileges.

The Hospital provided no consistent terminology to define Family Medicine Providers with Advanced Obstetric Privileges and without Advanced Obstetric Privileges in Hospital documents, credential files and interviews.

The Hospital provided no documentation to indicate the Governing Body held the Medical Staff accountable for clear criteria and scopes of practice for Family Medicine Providers who the Governing Body credentialed and privileged to care for low-risk and high-risk obstetric Hospital patients.

Based on records reviewed and interviews, the Governing Body failed for six (Patients #1, #2, #3, #5, #6, & #8) of eleven sampled patients to ensure investigations of adverse obstetric patient events were thorough and timely, that corrective actions were implemented and monitored (audited) for compliance and that expert medical reviews were conducted as appropriate.

Findings include:

A.) Regarding the failure of the Governing Body to ensure that Medical Staff implemented one (1) obstetric care guideline for all obstetric patients at the Hospital as requested by the Hospital Executives.

The Surveyor interviewed the Chief Medical Officer and Quality Director at 10:35 A.M. on 8/29/18. The Chief Medical Officer said Hospital Executives requested of the Obstetric and Family Medicine Departments to develop one obstetric care guideline for all obstetric patients following the newborn deaths of Patients #1 and #3 in April 2018. The Chief Medical Officer said that as of now, 8/29/18, the Obstetrics and Family Medicine Departments did not develop and did not implement an obstetric care guideline for all Hospital obstetric patients, regardless of Provider (Obstetric or Family Medicine) type by the time of the Survey.

B.) The History & Physical, dated 4/09/18 at 9:19 A.M., indicated Patient #5 with a 41 week gestation pregnancy was obese with a Body Mass Index (BMI) of 35 (BMI greater than 30 is considered obese). The History & Physical indicated Patient #5 was admitted for induction (to start) of labor for late term, (over 40 weeks gestation) by an Attending Family Medicine Physician who was not credentialed to provide obstetric care/services with Advanced Obstetric Privileges.

The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Hospital would like Family Medicine to admit high-risk obstetric patients to a Family Medicine Physician with Advanced Obstetric Privileges. The Chief Medical Officer said effective as of today, 9/6/18 (during the Survey), Family Medicine started to admit to the Hospital high-risk obstetric patients to a Family Medicine Physician with Advanced Obstetric Privileges.

The Hospital provided no indication that the Medical Staff investigation processes discovered that the Hospital admitted high-risk obstetric patients to the Hospital as assigned to an on-call Family Medicine Physician without Advanced Obstetric Privileges and, therefore; the Hospital had no corrective actions implemented by the time of the Survey.

C.) Regarding the failure of the Governing Body to ensure the CEO was responsible for the Medical Staff implementation of Interdisciplinary TeamSTEPPS (a training of education & simulation to advance interdisciplinary health care givers communication skills and therefore improving patient safety to decrease adverse patient events) according to Hospital investigation corrective actions.

The Hospital investigation dated, 8/16/18, indicated a corrective action that Providers (Obstetricians & Family Medicine Physicians) would complete TeamSTEPPS training. The Hospital investigation indicated no documentation that the corrective action was implemented at the time of the Survey.

D.) Regarding the failure of the Hospital to implement preventative evidence based obstetric practices.

The Hospital Guideline titled Postpartum Care, dated 3/5/15, indicated that the first two hours after Cesarean delivery were the highest risk for post-partum hemorrhage and close monitoring was warranted. The Postpartum Care Guideline indicated that lochia (vaginal discharge after birth) was only measured after lochia was noted to be heavy, excessive bleeding defined as saturating a peri-pad within 15 minutes or saturation of two pads in the first hour. The Guideline included no information to indicate measurement of all blood loss.

The Association of Women's Health, Obstetric and Neonatal Nurses, Practice Brief, dated 2015, recommends cumulative blood loss be formally measured or quantified after every birth.

Hospital staff estimated maternal blood loss in four (Patients #2, #5, #6, & #8) of eleven sampled patients.

The Hospital provided no documentation to indicate implementation of quantified blood loss after every delivery.

The Hospital was out of compliance with the Quality Assessment & Performance Improvement (QAPI) Condition of Participation.

Findings include:

The Hospital failed to ensure Quality Assessment & Performance Improvement (QAPI) activities were thorough and that corrective actions were implemented. The Hospital failed to ensure that Quality Assessment & Performance Improvement (QAPI) activities:

1.) Failed to identify and develop a corrective action regarding the Family Medicine Department admitting high-risk obstetric patients (the mother or the baby have a higher risk of complications) to a Family Medicine Physician without Advanced Obstetric Privileges, prior to the Survey,

2.) Failed to implement corrective actions regarding one of the operating rooms in Labor & Deliver that did not have an Electronic Fetal Monitor to simultaneously evaluate maternal fetal heart rate immediately prior to surgical preparation for a Cesarean Section,

3.) Failed to identify that Patient #5, who had an elevated white blood cell count at the time of admission for induction of labor, was monitored during labor,

4.) Failed to identify and implement corrective actions regarding Obstetric & Family Medicine Providers and Hospital staff who were estimating patient blood loss which was not in accordance with obstetric standards of care,

5.) Failed to identify the lack of a clear definition of a high-risk pregnancy,

6.) Failed to identify that all patients, including newborns delivered without signs of life, required their own medical record,

7.) Failed to identify that the Hospital did not have a process to evaluate neonatal resuscitations for improvement measures,

8.) Failed to identify that Patient #7's umbilical cord blood gas sampling was not obtained according to Hospital policy and procedures,

9.) Failed to identify and implement corrective actions regarding Hospital operating rooms in Labor & Delivery and the Hospital's Main Operating Rooms delivered like post-regional anesthesia standards of care,

10.) Failed to implement TeamSTEPPS for all members of the interdisciplinary team that cared for obstetric Hospital patients according to the Hospital investigation corrective action and

11.) Failed to identify and implement corrective actions regarding Fetal Monitoring Competency and policy regarding time limits for obstetric patients to be off the electronic fetal monitor.

Refer to TAG: A-0286

Based on records reviewed and interviews, the Governing Body failed for six (Patients #1, #2, #3, #5, #6, & #8) of eleven sampled patients to ensure investigations of adverse obstetric patient events were thorough and timely, that corrective actions were implemented and monitored (audited) for compliance and that expert medical reviews were conducted as appropriate.

Findings include:

A.) Regarding the failure of the Governing Body to ensure that Medical Staff implemented one (1) obstetric care guideline for all obstetric patients at the Hospital as requested by the Hospital Executives.

The Surveyor interviewed the Chief Medical Officer and Quality Director at 10:35 A.M. on 8/29/18. The Chief Medical Officer said Hospital Executives requested of the Obstetric and Family Medicine Departments to develop one obstetric care guideline for all obstetric patients following the newborn deaths of Patients #1 and #3 in April 2018. The Chief Medical Officer said that as of now, 8/29/18, the Obstetrics and Family Medicine Departments did not develop and did not implement an obstetric care guideline for all Hospital obstetric patients, regardless of Provider (Obstetric or Family Medicine) type by the time of the Survey.

B.) The History & Physical, dated 4/09/18 at 9:19 A.M., indicated Patient #5 with a 41 week gestation pregnancy was obese with a Body Mass Index (BMI) of 35 (BMI greater than 30 is considered obese). The History & Physical indicated Patient #5 was admitted for induction (to start) of labor for late term, (over 40 weeks gestation) by an Attending Family Medicine Physician who was not credentialed to provide obstetric care/services with Advanced Obstetric Privileges.

The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Hospital would like Family Medicine to admit high-risk obstetric patients to a Family Medicine Physician with Advanced Obstetric Privileges. The Chief Medical Officer said effective as of today, 9/6/18 (during the Survey), Family Medicine started to admit to the Hospital high-risk obstetric patients to a Family Medicine Physician with Advanced Obstetric Privileges.

The Hospital provided no indication that the Medical Staff investigation processes discovered that the Hospital admitted high-risk obstetric patients to the Hospital as assigned to an on-call Family Medicine Physician without Advanced Obstetric Privileges and, therefore; the Hospital had no corrective actions implemented by the time of the Survey.

C.) Regarding the failure of the Governing Body to ensure the CEO was responsible for the Medical Staff implementation of Interdisciplinary TeamSTEPPS (a training of education & simulation to advance interdisciplinary health care givers communication skills and therefore improving patient safety to decrease adverse patient events) according to Hospital investigation corrective actions.

The Hospital investigation dated, 8/16/18, indicated a corrective action that Providers (Obstetricians & Family Medicine Physicians) would complete TeamSTEPPS training. The Hospital investigation indicated no documentation that the corrective action was implemented at the time of the Survey.

D.) Regarding the failure of the Hospital to implement preventative evidence based obstetric practices.

The Hospital Guideline titled Postpartum Care, dated 3/5/15, indicated that the first two hours after Cesarean delivery were the highest risk for post-partum hemorrhage and close monitoring was warranted. The Postpartum Care Guideline indicated that lochia (vaginal discharge after birth) was only measured after lochia was noted to be heavy, excessive bleeding defined as saturating a peri-pad within 15 minutes or saturation of two pads in the first hour. The Guideline included no information to indicate measurement of all blood loss.

The Association of Women's Health, Obstetric and Neonatal Nurses, Practice Brief, dated 2015, recommends cumulative blood loss be formally measured or quantified after every birth.

Hospital staff estimated maternal blood loss in four (Patients #2, #5, #6, & #8) of eleven sampled patients.

The Hospital provided no documentation to indicate implementation of quantified blood loss after every delivery.

The Hospital was out of compliance with the Medical Staff Condition of Participation.

Findings include:

The Medical Staff failed to ensure that the Governing Body specified scopes of obstetric practice in accordance with Medical Staff Bylaws and Medical Staff Rules & Regulations.

Refer to TAG: A-0339.

The Medical Staff failed for eight (Patients #1, #2, #3, #4, #5, #6, #7, #8) of eleven sampled patients to ensure that quality medical care was provided to patients through Medical Staff investigations of adverse patient events.

Refer to TAG: A-0347.

The Medical Staff failed to ensure that the two categories of Medical Staff (Obstetric and Family Medicine Departments) that delivered obstetric care, regulated themselves.

Refer to TAG: A-0353.

The Medical Staff failed to ensure that obstetric services provided to Hospital patients were clearly described with acceptable standards of obstetric care in the Medical Staff Bylaws and Medical Staff Rules & Regulations.

Refer to TAG: A-0356.

Based on interviews and records reviewed the Medical Staff failed to ensure that the Governing Body specified scopes of obstetric practice in accordance with Medical Staff Bylaws and Medical Staff Rules & Regulations.

Findings include:

A.) The Medical Staff Bylaws, dated 6/14/16, and Medical Staff Rules and Regulations, dated 6/13/17, indicated Family Medicine Physicians were active members in the Department of Family Medicine and practiced within their scope of privileges, which may include Obstetrics & Gynecology. The Medical Staff Bylaws and Medical Staff Rules and Regulations indicated no specified scopes of obstetric practice for the two Hospital Medical Departments practicing obstetrics, Obstetrics and Family Medicine, and did not indicate when Obstetric consultation was appropriate. The Medical Staff Bylaws and Medical Staff Rules and Regulations did not indicate the two levels of Family Medicine Providers privileged to provide obstetric care to Hospital patients.

The Surveyor interviewed the Chief of Obstetrics at 12:00 P.M. on 8/30/18. The Chief of Obstetrics said Family Medicine does their own credentialing of obstetric practice and the Chief of Family Medicine "signed-off" on the obstetric privileges. The Chief of Obstetrics said Family Medicine had three levels; Physicians without obstetric privileges, Physicians with low-risk obstetric privileges and Physicians with high-risk obstetric privileges (Advanced Obstetric Privileges).

The Surveyor interviewed the Chief of Family Medicine, at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said that the Family Medicine literature identified Family Medicine Providers that care for high-risk obstetric patients as having Advanced Obstetric Privileges.

The Hospital provided no consistent terminology to define Family Medicine Providers with Advanced Obstetric Privileges and without Advanced Obstetric Privileges in Hospital documents, credential files and interviews.

B.) The Medical Staff Bylaws Rules & Regulations indicated that the Hospital credentialed Physician Assistants and Advanced Practice Nurses as members of the Medical Staff. The Medical Staff Bylaws Rules & Regulations did not indicate specific criteria of Advanced Practice Nurses such as Certified Nurse Practitioners, Nurse Anesthetists, Nurse Practitioners: nor were any specific duties, procedures and or scopes of practice identified.

Based on records reviewed and interviews the Medical Staff failed for eight (Patients #1, #2, #3, #4, #5, #6, #7 & #8) of eleven sampled patients to ensure quality of medical care provided to patients through Medical Staff investigations of adverse obstetric patient events.

Findings include:

A.) Regarding the failure of the Medical Staff to timely implement corrective actions as requested by the Hospital:

The Surveyor interviewed the Chief Medical Officer and Quality Director at 10:35 A.M. on 8/29/18. The Chief Medical Officer said that the Hospital had two medical cultures of practice regarding obstetric care. The Chief Medical Officer said that, the following the newborn deaths of Patients #1 & #3 in April of 2018, Hospital Executives requested that the Obstetric and Family Medicine Departments develop one Obstetric care guideline for all obstetric patients at the Hospital. The Chief Medical Officer said the Obstetrics & Family Medicine Departments did not revise the Family Medicine Departmental policy titled Family Medicine Consultation Escalation Policy until after the Hospital's third newborn death of Patient #4 in August 2018. The Chief Medical Officer said that Obstetrics and Family Medicine Departments did not develop and did not implement one obstetric care guideline for all Hospital obstetric patients by the time of the Survey.

B.) Regarding the failure of the Medical Staff to identify processes of improvement regarding the obstetric medical care provided:

1.) Regarding the Medical Staff investigations failure to identify the lack of a clear definition of a high-risk pregnancy. The Medical Staff also failed to identify the lack of a clear definition of a Family Medicine Provider that was privileged to care for high-rick Obstetric patients.

a.) The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Family Medicine Consultation Escalation Policy described the criteria which identifies a high-risk obstetric patient.

The policy titled, Family Medicine Consultation Escalation Policy, dated 8/8/18, indicated criteria when a Family Medicine Physician without Obstetric Advanced Privileges consulted with a Family Medicine Physician with Obstetric Advanced Privileges and when they consulted with an Obstetrician. The Family Medicine Consultation Escalation Policy did not indicate clear criteria that identified high-risk obstetric patients effective for all Providers and disciplines (Medicine, Nursing, and Respiratory Care) that cared for obstetric patients.

b.) The Surveyor interviewed the Chief of Family Medicine, at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said that the Family Medicine literature (books and writings published on a particular subject) identified Family Medicine Providers that care for high-risk obstetric patients as having Advanced Obstetric Privileges.

The Privileges Request Form indicated inconsistent terminology for Family Medicine Providers that provided care to high-risk mothers. The Privileges Request Form indicated Family Medicine Providers that cared for high-risk obstetric patients had Extended Obstetric Privileges. The Privileges Request Form did not indicate Family Medicine Providers as having Advanced Obstetric Privileges.

The document titled, Admit by High Low Risk Provider, dated 9/7/18, indicated inconsistent language for Family Medicine Providers that provided care to obstetric patients. The Admit by High Low Risk Provider document indicated obstetric patients were admitted by either a Low-Risk Family Medicine Provider or a High-Risk Family Medicine Provider.

The Hospital provided no consistent terminology to define Family Medicine Providers with Advanced Obstetric Privileges and without Advanced Obstetric Privileges in Hospital documents, credential files and interviews.

2.) Regarding Medical Staff investigations to identify and develop a corrective action plan regarding the Family Medicine Department admitting high-risk obstetric patients to a Family Medicine Physician without Advanced Obstetric Privileges prior to the Survey:

Regarding Patient #5:

The History & Physical dated 4/09/18 at 9:19 A.M. indicated Patient #5 with a 41 week gestation pregnancy as obese and admitted for induction (to start) of labor for late term, (over 40 weeks gestation) and Patient #5's attending physician as a Family Medicine Physician without Extended Obstetric Privileges (inconsistent terminology).

The document titled Admit by High & Low Risk Provider, dated 9/1/18, indicated Patient #5's attending Physician as a Low Risk Provider, (without Advanced Obstetric Privileges).

Credential Files for Patient #5's attending Family Medicine Provider did not indicate the Governing Body credentialed and privileged Patient #5's attending Family Medicine Provider with Advanced Obstetric Privileges.

Regarding Patient #6:

The Discharge Summary, dated 8/5/18, indicated Patient #6 presented to Labor & Deliver for induction of labor for maternal history of gestational hypertension (high blood pressure diagnosed during pregnancy).

The Surveyor interviewed the Quality Director at 12:50 P.M. on 9/6/18. The Quality Director said that a Family Medicine Physician without Advanced Obstetric Privileges admitted Patient #6 to the Hospital. The Quality Director said Patient #6 had medical diagnoses of gestational (during pregnancy) hypertension (high blood pressure) and obesity (high-risk pregnancy- pregnancy that threatens the health or life of the mother or her fetus, risk factors for a high-risk pregnancy can include high blood pressure and obesity; National Institute of Health). The Quality Director said the Family Medicine Department admitted their obstetric patients to the Family Medicine Physician on-call (that is the Family Medicine Department admitted high-risk obstetric patients to the on-call Family Medicine Physician even if the Governing Body credentialed the on-call Family Medicine Physician without Advanced Obstetric Privileges). The Quality Director said she did not know if the Family Medicine Department admitted high-risk obstetric patients to Family Medicine Physician without Advanced Obstetric Privileges. The Quality Director said that both Family Medicine Physicians with and without Advanced Obstetric Privileges cared for Patient #6. The Quality Director said the higher level-of-care hospital the Hospital transferred Patient #6's baby (Patient #4) to, diagnosed Patient #4 with a subgaleal hemorrhage (the life-threatening rupture of a blood vessel from birth trauma causing accumulation of blood between the skull bone and the scalp).

Regarding admissions of high-risk Obstetric patients:

The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Hospital would like to admit high-risk obstetric Family Medicine patients to Family Medicine Physicians with Advanced Obstetric Privileges; however, the Hospital needed to define this process better.

The Chief Medical Officer said the Hospital would like Family Medicine to admit high-risk obstetric patients to a Family Medicine Physician with Advanced Obstetric Privileges and that it would be effective as of today (9/6/18, during the Survey).

The Hospital provided no indication that the Medical Staff investigation processes discovered that the Hospital admitted high-risk obstetric patients to the Hospital as assigned to an on-call Family Medicine Physician without Advanced Obstetric Privileges and, therefore, the Hospital had no corrective actions implemented by the time of the Survey.

3.) A laboratory blood test result, timed 8:06 A.M. and dated 4/9/18, indicated Patient #5 had an elevated white blood cell count of 10.8 (normal 4.7-10.6). The elevated white blood cell count indicate a possible infection.

The Chief Medical Officer said Patient #5's elevated white blood cell count was not discussed during the medical care review.

The internal investigation regarding Patient #5's labor care and subsequent birth of her non-viable infant (Patient #1), reviewed on 8/29/18 at 9:35 A.M., did not identify Patient #5 had an elevated white blood cell count at the time of admission nor that a plan was developed for monitoring an elevated white blood cell count of laboring patients.

4.) The Hospital's Policy and Procedure titled, Cord (Umbilical Cord) Gas Sampling (laboratory test), dated 2/10/14, indicated the umbilical cord would be immediately clamped, cut and placed on ice as applicable. A medical doctor or respiratory therapy staff would obtain the umbilical cord blood sample for analysis.

The Operative Report for Patient #7, dated 9/23/17, indicated that an umbilical cord blood gas sample was sent to the laboratory; however, the umbilical cord had been draining blood and was open to the air for 30 to 40 minutes prior to drawing the umbilical blood sample for analysis. The umbilical cord blood gas sample was not placed on ice for 40 minutes prior to drawing.

The Hospital investigation regarding Patient #7's Trial of Labor After Caesarian section did not identify that the umbilical cord blood gas sample was not obtained according to policy and procedures and corrective actions were not implemented.

The Chief Medical Officer (CMO) was interviewed at 1:30 P.M. on 9/5/18. The CMO said Patient #7's medical care regarding the improper collection of an umbilical cord blood gas was not identified or discussed.

5.) Regarding the medical investigation to discover and implement corrective actions regarding that the Hospital estimated blood loss and not measuring blood loss in accordance with obstetric standards of care.

Hospital staff estimated maternal blood loss in four (Patients #2, #5, #6, & #8) of 11 sampled patients.

The Hospital Guideline titled Postpartum Care, dated 3/5/15, indicated that the first two hours after Cesarean delivery were the highest risk for postpartum hemorrhage and close monitoring was warranted. The Hospital Postpartum Care Guideline indicated that vaginal discharge after birth was only measured after it became heavy, excessive bleeding defined as saturating a peri-pad within 15 minutes or saturation of two pads in the first hour. The Hospital Guideline titled Postpartum Care did not indicate to measure all blood loss according to obstetric standards of care.

The Association of Women's Health, Obstetric and Neonatal Nurses, Practice Brief, dated 2015, indicates obstetric standards of care and recommends cumulative blood loss be formally measured or quantified after every birth.

The Operative Note, dated 4/26/18 at 5:16 P.M., indicated Patient #2 had a blood loss estimated as 1700 milliliters (greater than 7 cups).

The Discharge Summary, dated 4/12/18, indicated Patient #5 with a postpartum hemorrhage and an estimated blood loss of 850 milliliters requiring medications and a Bakri balloon (obstetric device to manage postpartum hemorrhage) to manage the postpartum hemorrhage.

The Discharge Summary, dated 8/5/18, indicated Patient #6 had a Cesarean section with an estimated blood loss of 600 milliliters.

The Operative Report, dated 9/23/17, indicated Patient #8 with a postpartum hemorrhage and an estimated blood loss of 1800 milliliters.

The Surveyor interviewed Staff Nurse #1 at 11:00 A.M. on 8/30/18. Staff Nurse #1 said that the Hospital estimated blood loss.

The Surveyor interviewed the Maternity Nurse Manager at 11:00 A.M. on 9/11/18, during a medical record review. The Maternity Nurse Manager said the Physician estimated the blood loss for Cesarean and vaginal deliveries. The Nurse Manager said that the staff only measured blood loss with hemorrhages and the staff did not routinely measure blood loss for all Cesarean and vaginal deliveries.

The Discharge Summaries indicated estimated blood loss for Patients #5 & #8, who both had postpartum hemorrhages.

6.) Regarding the Medical Staff failure to discover and inform the Hospital that one of the operating rooms in Labor & Deliver did not have an Electronic Fetal Monitor to simultaneously evaluate maternal fetal heart rate immediately prior to surgical preparation for a Cesarean Section:

The Discharge Summary indicated Patient #2's uterine rupture was noted on start of a Cesarean section for labor progression. The Discharge Summary indicated Hospital staff implemented newborn (Patient #3) resuscitation efforts and the newborn died.

The Surveyor interviewed Staff Nurse #2, at 1:30 P.M. on 8/30/18. Staff Nurse #2 said that she cared for Patient #2 and the Labor & Delivery operating room used did not have an Electronic Fetal Monitor. Staff Nurse #2 said Obstetrician #1 obtained a fetal heart rate, as normal, with a Doppler (medical device to auscultate the fetal heart rate).

The Surveyor interviewed Obstetrician #1 at 9:00 A.M. on 8/30/18. Obstetrician #1 said Patient #3's fetal heart rate was 140 beats per minute (normal fetal heart rate) by Doppler. Obstetrician #1 said that the operating room did not have an electronic fetal monitor. Obstetrician #1 said the maternal heart rate (Patient #2) was tachycardic (high heart rate) and possibly the Doppler heart rate obtained, as 140 (tachycardic) was the maternal heart rate (not the fetal, Patient #3's) heart rate.

7.) Regarding the failure of the Medical Staff failure to ensure all Medical Staff Departmental policies were consistent with the Medical Staff Bylaws:

The Surveyor interviewed the Chief of Family Medicine at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said the Family Medicine Department included Family Medicine Physicians with obstetric credentials that the Hospital privileged to deliver babies at the Hospital. The Chief of Family Medicine said that the Family Medicine Department included Family Medicine Physicians credentialed with Advanced Obstetric Privileges to deliver babies of high-risk mothers. The Chief of Family Medicine said Family Medicine Physicians evaluated mothers as high-risk in the Family Medicine outpatient setting. The Chief of Family Medicine said the Hospital admitted high-risk mothers to Family Medicine Physicians that were not credentialed with Advanced Obstetric Privileges.

Regarding Patient #6:

The Discharge Summary, dated 8/5/18, indicated Patient #6 presented to Labor & Deliver for induction of labor for maternal history of gestational hypertension. The Discharge Summary indicated a Family Medicine Physician attempted to deliver the baby (Patient #4) by a vacuum assisted delivery (an obstetric method to assist a vaginal delivery). The Discharge Summary indicated the Hospital transferred Patient #4 to a Neonatal Intensive Care Unit where Patient #4 died.

The policy titled Operative Assisted Births Vacuum and Forceps, dated 8/2009, indicated that the Hospital required physicians to have credentials & privileges to perform vacuum assisted deliveries.

The Family Medicine Labor & Delivery Consult Guidelines, dated 1/2018, indicated a vacuum assisted delivery required the consult of a Family Medicine Provider with extended privileges (Advanced Obstetric Privileges) or an Obstetrician. The Family Medicine Labor & Delivery Consult Guidelines indicated that although the vacuum assisted delivery procedure requiring the consultant's presence (Family Medicine Physician with Advanced Obstetric Privileges) the vaginal assisted delivery procedure may be initiated in an emergency assuming that the consult was notified and in route.

The policy titled Operative Assisted Births Vacuum and Forceps and the Family Medicine Labor & Delivery Consult Guidelines indicated conflicting information regarding physicians privileged to perform vacuum assisted deliveries.

The Quality Director said that Anesthesia Services provided Patient #6 with an epidural (procedure used by Anesthesia during labor to relieve pain). The Quality Director said a Family Medicine Physician performed Patient #6's vacuum assisted delivery without Advanced Obstetric Privileges, and that another physician, Family Medicine Physician #1 performed Patient #6's Cesarean section.

The document titled, Admit by High Low Risk Provider, indicated the Family Medicine Physician that performed Patient #6's vacuum assisted delivery, as a Low-Risk Provider (Family Medicine Physician without Advanced Obstetric Privileges).

The Surveyor interviewed the Quality Director at 3:45 P.M. on 9/4/18. The Quality Director said the Family Medicine Labor & Delivery Consult Guidelines were revised and retitled as the Family Medicine Consultation Escalation Policy. The Quality Director said the Family Medicine Labor & Delivery Consult Guidelines were not approved by the Medical Staff and not approved by the Governing Body. The Quality Director said the policy titled Family Medicine Consultation Escalation Policy, dated 8/8/18, was not approved by the Medical Executive Committee (by the date of the Survey on 8/29/18).

The Surveyor interviewed the Chief Executive Officer at 2:30 P.M. on 9/10/18. The Chief Executive Officer said Medical Staff Departmental Policies (policies regarding Medical Departments) were not reviewed at the Medical Executive Committee (by the time of the Survey) for consistency with Medical Staff Bylaws (and Medical Staff privileges granted by the Governing Body).

8.) The Surveyor interviewed the Chief of Family Medicine at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said she was not familiar with Maternal Early Warning Systems (MEWS, have defined obstetric early warning vital signs documented in the electronic medical record and effective escalation policies).

9.) The Hospital Policy titled, Discharge Criteria for the Post-Anesthesia Care Unit (PACU), dated 12/2007, indicated that the physiological criteria that must be met for the safe discharge from the PACU, inclusive of a post-anesthetic recovery score system used by the PACU Registered Nurse to assess a patient's readiness for discharge from post-anesthesia care. The Discharge Criteria for the Post-Anesthesia Care Unit policy indicated the following criteria will be utilized for discharging patients from the PACU without the evaluation of the patient by Anesthesia Services:

-Stable vital signs for 30 minutes prior to discharge;

-Return to baseline mental status;

-No airway difficulty, no active bleeding, no vomiting, no anesthesia reaction;

-Mild to moderate pain, minimal nausea;

-If the patient received spinal or epidural anesthesia, she has begun to regain lower extremity strength and sensation;

-and attainment of a Post-Anesthesia Recovery Score (evaluation of extremity movement, breathing, blood pressure, responsiveness and color) of eight or greater.

The Hospital policy titled Cesarean Section Deliveries, dated 8/2018, did not indicate when general anesthesia was indicated. The policy did not indicate post-anesthesia care criteria for discharge from post-regional anesthesia (the delivery of anesthetic medication at a specific level of the spinal cord including epidurals and spinals) care.

The Hospital Maternal Child Services provided no post-anesthesia care policy consistent with the Surgical Services post-anesthesia care policy regarding regional anesthesia.

The Hospital provided no policies to indicate Cesarean section patients received the same post-anesthesia standard of care as patients in the Surgical Services patients receiving post-regional anesthesia.

Based on records reviewed and interviews the Medical Staff failed for eight (Patients #1, #2, #3, #4, #5, #6, #7 & #8) of eleven sampled patients to ensure quality of medical care provided to patients through Medical Staff investigations of adverse obstetric patient events.

Findings include:

A.) Regarding the failure of the Medical Staff to timely implement corrective actions as requested by the Hospital:

The Surveyor interviewed the Chief Medical Officer and Quality Director at 10:35 A.M. on 8/29/18. The Chief Medical Officer said that the Hospital had two medical cultures of practice regarding obstetric care. The Chief Medical Officer said that, the following the newborn deaths of Patients #1 & #3 in April of 2018, Hospital Executives requested that the Obstetric and Family Medicine Departments develop one Obstetric care guideline for all obstetric patients at the Hospital. The Chief Medical Officer said the Obstetrics & Family Medicine Departments did not revise the Family Medicine Departmental policy titled Family Medicine Consultation Escalation Policy until after the Hospital's third newborn death of Patient #4 in August 2018. The Chief Medical Officer said that Obstetrics and Family Medicine Departments did not develop and did not implement one obstetric care guideline for all Hospital obstetric patients by the time of the Survey.

B.) Regarding the failure of the Medical Staff to identify processes of improvement regarding the obstetric medical care provided:

1.) Regarding the Medical Staff investigations failure to identify the lack of a clear definition of a high-risk pregnancy. The Medical Staff also failed to identify the lack of a clear definition of a Family Medicine Provider that was privileged to care for high-rick Obstetric patients.

a.) The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Family Medicine Consultation Escalation Policy described the criteria which identifies a high-risk obstetric patient.

The policy titled, Family Medicine Consultation Escalation Policy, dated 8/8/18, indicated criteria when a Family Medicine Physician without Obstetric Advanced Privileges consulted with a Family Medicine Physician with Obstetric Advanced Privileges and when they consulted with an Obstetrician. The Family Medicine Consultation Escalation Policy did not indicate clear criteria that identified high-risk obstetric patients effective for all Providers and disciplines (Medicine, Nursing, and Respiratory Care) that cared for obstetric patients.

b.) The Surveyor interviewed the Chief of Family Medicine, at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said that the Family Medicine literature (books and writings published on a particular subject) identified Family Medicine Providers that care for high-risk obstetric patients as having Advanced Obstetric Privileges.

The Privileges Request Form indicated inconsistent terminology for Family Medicine Providers that provided care to high-risk mothers. The Privileges Request Form indicated Family Medicine Providers that cared for high-risk obstetric patients had Extended Obstetric Privileges. The Privileges Request Form did not indicate Family Medicine Providers as having Advanced Obstetric Privileges.

The document titled, Admit by High Low Risk Provider, dated 9/7/18, indicated inconsistent language for Family Medicine Providers that provided care to obstetric patients. The Admit by High Low Risk Provider document indicated obstetric patients were admitted by either a Low-Risk Family Medicine Provider or a High-Risk Family Medicine Provider.

The Hospital provided no consistent terminology to define Family Medicine Providers with Advanced Obstetric Privileges and without Advanced Obstetric Privileges in Hospital documents, credential files and interviews.

2.) Regarding Medical Staff investigations to identify and develop a corrective action plan regarding the Family Medicine Department admitting high-risk obstetric patients to a Family Medicine Physician without Advanced Obstetric Privileges prior to the Survey:

Regarding Patient #5:

The History & Physical dated 4/09/18 at 9:19 A.M. indicated Patient #5 with a 41 week gestation pregnancy as obese and admitted for induction (to start) of labor for late term, (over 40 weeks gestation) and Patient #5's attending physician as a Family Medicine Physician without Extended Obstetric Privileges (inconsistent terminology).

The document titled Admit by High & Low Risk Provider, dated 9/1/18, indicated Patient #5's attending Physician as a Low Risk Provider, (without Advanced Obstetric Privileges).

Credential Files for Patient #5's attending Family Medicine Provider did not indicate the Governing Body credentialed and privileged Patient #5's attending Family Medicine Provider with Advanced Obstetric Privileges.

Regarding Patient #6:

The Discharge Summary, dated 8/5/18, indicated Patient #6 presented to Labor & Deliver for induction of labor for maternal history of gestational hypertension (high blood pressure diagnosed during pregnancy).

The Surveyor interviewed the Quality Director at 12:50 P.M. on 9/6/18. The Quality Director said that a Family Medicine Physician without Advanced Obstetric Privileges admitted Patient #6 to the Hospital. The Quality Director said Patient #6 had medical diagnoses of gestational (during pregnancy) hypertension (high blood pressure) and obesity (high-risk pregnancy- pregnancy that threatens the health or life of the mother or her fetus, risk factors for a high-risk pregnancy can include high blood pressure and obesity; National Institute of Health). The Quality Director said the Family Medicine Department admitted their obstetric patients to the Family Medicine Physician on-call (that is the Family Medicine Department admitted high-risk obstetric patients to the on-call Family Medicine Physician even if the Governing Body credentialed the on-call Family Medicine Physician without Advanced Obstetric Privileges). The Quality Director said she did not know if the Family Medicine Department admitted high-risk obstetric patients to Family Medicine Physician without Advanced Obstetric Privileges. The Quality Director said that both Family Medicine Physicians with and without Advanced Obstetric Privileges cared for Patient #6. The Quality Director said the higher level-of-care hospital the Hospital transferred Patient #6's baby (Patient #4) to, diagnosed Patient #4 with a subgaleal hemorrhage (the life-threatening rupture of a blood vessel from birth trauma causing accumulation of blood between the skull bone and the scalp).

Regarding admissions of high-risk Obstetric patients:

The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said the Hospital would like to admit high-risk obstetric Family Medicine patients to Family Medicine Physicians with Advanced Obstetric Privileges; however, the Hospital needed to define this process better.

The Chief Medical Officer said the Hospital would like Family Medicine to admit high-risk obstetric patients to a Family Medicine Physician with Advanced Obstetric Privileges and that it would be effective as of today (9/6/18, during the Survey).

The Hospital provided no indication that the Medical Staff investigation processes discovered that the Hospital admitted high-risk obstetric patients to the Hospital as assigned to an on-call Family Medicine Physician without Advanced Obstetric Privileges and, therefore, the Hospital had no corrective actions implemented by the time of the Survey.

3.) A laboratory blood test result, timed 8:06 A.M. and dated 4/9/18, indicated Patient #5 had an elevated white blood cell count of 10.8 (normal 4.7-10.6). The elevated white blood cell count indicate a possible infection.

The Chief Medical Officer said Patient #5's elevated white blood cell count was not discussed during the medical care review.

The internal investigation regarding Patient #5's labor care and subsequent birth of her non-viable infant (Patient #1), reviewed on 8/29/18 at 9:35 A.M., did not identify Patient #5 had an elevated white blood cell count at the time of admission nor that a plan was developed for monitoring an elevated white blood cell count of laboring patients.

4.) The Hospital's Policy and Procedure titled, Cord (Umbilical Cord) Gas Sampling (laboratory test), dated 2/10/14, indicated the umbilical cord would be immediately clamped, cut and placed on ice as applicable. A medical doctor or respiratory therapy staff would obtain the umbilical cord blood sample for analysis.

The Operative Report for Patient #7, dated 9/23/17, indicated that an umbilical cord blood gas sample was sent to the laboratory; however, the umbilical cord had been draining blood and was open to the air for 30 to 40 minutes prior to drawing the umbilical blood sample for analysis. The umbilical cord blood gas sample was not placed on ice for 40 minutes prior to drawing.

The Hospital investigation regarding Patient #7's Trial of Labor After Caesarian section did not identify that the umbilical cord blood gas sample was not obtained according to policy and procedures and corrective actions were not implemented.

The Chief Medical Officer (CMO) was interviewed at 1:30 P.M. on 9/5/18. The CMO said Patient #7's medical care regarding the improper collection of an umbilical cord blood gas was not identified or discussed.

5.) Regarding the medical investigation to discover and implement corrective actions regarding that the Hospital estimated blood loss and not measuring blood loss in accordance with obstetric standards of care.

Hospital staff estimated maternal blood loss in four (Patients #2, #5, #6, & #8) of 11 sampled patients.

The Hospital Guideline titled Postpartum Care, dated 3/5/15, indicated that the first two hours after Cesarean delivery were the highest risk for postpartum hemorrhage and close monitoring was warranted. The Hospital Postpartum Care Guideline indicated that vaginal discharge after birth was only measured after it became heavy, excessive bleeding defined as saturating a peri-pad within 15 minutes or saturation of two pads in the first hour. The Hospital Guideline titled Postpartum Care did not indicate to measure all blood loss according to obstetric standards of care.

The Association of Women's Health, Obstetric and Neonatal Nurses, Practice Brief, dated 2015, indicates obstetric standards of care and recommends cumulative blood loss be formally measured or quantified after every birth.

The Operative Note, dated 4/26/18 at 5:16 P.M., indicated Patient #2 had a blood loss estimated as 1700 milliliters (greater than 7 cups).

The Discharge Summary, dated 4/12/18, indicated Patient #5 with a postpartum hemorrhage and an estimated blood loss of 850 milliliters requiring medications and a Bakri balloon (obstetric device to manage postpartum hemorrhage) to manage the postpartum hemorrhage.

The Discharge Summary, dated 8/5/18, indicated Patient #6 had a Cesarean section with an estimated blood loss of 600 milliliters.

The Operative Report, dated 9/23/17, indicated Patient #8 with a postpartum hemorrhage and an estimated blood loss of 1800 milliliters.

The Surveyor interviewed Staff Nurse #1 at 11:00 A.M. on 8/30/18. Staff Nurse #1 said that the Hospital estimated blood loss.

The Surveyor interviewed the Maternity Nurse Manager at 11:00 A.M. on 9/11/18, during a medical record review. The Maternity Nurse Manager said the Physician estimated the blood loss for Cesarean and vaginal deliveries. The Nurse Manager said that the staff only measured blood loss with hemorrhages and the staff did not routinely measure blood loss for all Cesarean and vaginal deliveries.

The Discharge Summaries indicated estimated blood loss for Patients #5 & #8, who both had postpartum hemorrhages.

6.) Regarding the Medical Staff failure to discover and inform the Hospital that one of the operating rooms in Labor & Deliver did not have an Electronic Fetal Monitor to simultaneously evaluate maternal fetal heart rate immediately prior to surgical preparation for a Cesarean Section:

The Discharge Summary indicated Patient #2's uterine rupture was noted on start of a Cesarean section for labor progression. The Discharge Summary indicated Hospital staff implemented newborn (Patient #3) resuscitation efforts and the newborn died.

The Surveyor interviewed Staff Nurse #2, at 1:30 P.M. on 8/30/18. Staff Nurse #2 said that she cared for Patient #2 and the Labor & Delivery operating room used did not have an Electronic Fetal Monitor. Staff Nurse #2 said Obstetrician #1 obtained a fetal heart rate, as normal, with a Doppler (medical device to auscultate the fetal heart rate).

The Surveyor interviewed Obstetrician #1 at 9:00 A.M. on 8/30/18. Obstetrician #1 said Patient #3's fetal heart rate was 140 beats per minute (normal fetal heart rate) by Doppler. Obstetrician #1 said that the operating room did not have an electronic fetal monitor. Obstetrician #1 said the maternal heart rate (Patient #2) was tachycardic (high heart rate) and possibly the Doppler heart rate obtained, as 140 (tachycardic) was the maternal heart rate (not the fetal, Patient #3's) heart rate.

7.) Regarding the failure of the Medical Staff failure to ensure all Medical Staff Departmental policies were consistent with the Medical Staff Bylaws:

The Surveyor interviewed the Chief of Family Medicine at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said the Family Medicine Department included Family Medicine Physicians with obstetric credentials that the Hospital privileged to deliver babies at the Hospital. The Chief of Family Medicine said that the Family Medicine Department included Family Medicine Physicians credentialed with Advanced Obstetric Privileges to deliver babies of high-risk mothers. The Chief of Family Medicine said Family Medicine Physicians evaluated mothers as high-risk in the Family Medicine outpatient setting. The Chief of Family Medicine said the Hospital admitted high-risk mothers to Family Medicine Physicians that were not credentialed with Advanced Obstetric Privileges.

Regarding Patient #6:

The Discharge Summary, dated 8/5/18, indicated Patient #6 presented to Labor & Deliver for induction of labor for maternal history of gestational hypertension. The Discharge Summary indicated a Family Medicine Physician attempted to deliver the baby (Patient #4) by a vacuum assisted delivery (an obstetric method to assist a vaginal delivery). The Discharge Summary indicated the Hospital transferred Patient #4 to a Neonatal Intensive Care Unit where Patient #4 died.

The policy titled Operative Assisted Births Vacuum and Forceps, dated 8/2009, indicated that the Hospital required physicians to have credentials & privileges to perform vacuum assisted deliveries.

The Family Medicine Labor & Delivery Consult Guidelines, dated 1/2018, indicated a vacuum assisted delivery required the consult of a Family Medicine Provider with extended privileges (Advanced Obstetric Privileges) or an Obstetrician. The Family Medicine Labor & Delivery Consult Guidelines indicated that although the vacuum assisted delivery procedure requiring the consultant's presence (Family Medicine Physician with Advanced Obstetric Privileges) the vaginal assisted delivery procedure may be initiated in an emergency assuming that the consult was notified and in route.

The policy titled Operative Assisted Births Vacuum and Forceps and the Family Medicine Labor & Delivery Consult Guidelines indicated conflicting information regarding physicians privileged to perform vacuum assisted deliveries.

The Quality Director said that Anesthesia Services provided Patient #6 with an epidural (procedure used by Anesthesia during labor to relieve pain). The Quality Director said a Family Medicine Physician performed Patient #6's vacuum assisted delivery without Advanced Obstetric Privileges, and that another physician, Family Medicine Physician #1 performed Patient #6's Cesarean section.

The document titled, Admit by High Low Risk Provider, indicated the Family Medicine Physician that performed Patient #6's vacuum assisted delivery, as a Low-Risk Provider (Family Medicine Physician without Advanced Obstetric Privileges).

The Surveyor interviewed the Quality Director at 3:45 P.M. on 9/4/18. The Quality Director said the Family Medicine Labor & Delivery Consult Guidelines were revised and retitled as the Family Medicine Consultation Escalation Policy. The Quality Director said the Family Medicine Labor & Delivery Consult Guidelines were not approved by the Medical Staff and not approved by the Governing Body. The Quality Director said the policy titled Family Medicine Consultation Escalation Policy, dated 8/8/18, was not approved by the Medical Executive Committee (by the date of the Survey on 8/29/18).

The Surveyor interviewed the Chief Executive Officer at 2:30 P.M. on 9/10/18. The Chief Executive Officer said Medical Staff Departmental Policies (policies regarding Medical Departments) were not reviewed at the Medical Executive Committee (by the time of the Survey) for consistency with Medical Staff Bylaws (and Medical Staff privileges granted by the Governing Body).

8.) The Surveyor interviewed the Chief of Family Medicine at 10:00 A.M. on 9/6/18. The Chief of Family Medicine said she was not familiar with Maternal Early Warning Systems (MEWS, have defined obstetric early warning vital signs documented in the electronic medical record and effective escalation policies).

9.) The Hospital Policy titled, Discharge Criteria for the Post-Anesthesia Care Unit (PACU), dated 12/2007, indicated that the physiological criteria that must be met for the safe discharge from the PACU, inclusive of a post-anesthetic recovery score system used by the PACU Registered Nurse to assess a patient's readiness for discharge from post-anesthesia care. The Discharge Criteria for the Post-Anesthesia Care Unit policy indicated the following criteria will be utilized for discharging patients from the PACU without the evaluation of the patient by Anesthesia Services:

-Stable vital signs for 30 minutes prior to discharge;

-Return to baseline mental status;

-No airway difficulty, no active bleeding, no vomiting, no anesthesia reaction;

-Mild to moderate pain, minimal nausea;

-If the patient received spinal or epidural anesthesia, she has begun to regain lower extremity strength and sensation;

-and attainment of a Post-Anesthesia Recovery Score (evaluation of extremity movement, breathing, blood pressure, responsiveness and color) of eight or greater.

The Hospital policy titled Cesarean Section Deliveries, dated 8/2018, did not indicate when general anesthesia was indicated. The policy did not indicate post-anesthesia care criteria for discharge from post-regional anesthesia (the delivery of anesthetic medication at a specific level of the spinal cord including epidurals and spinals) care.

The Hospital Maternal Child Services provided no post-anesthesia care policy consistent with the Surgical Services post-anesthesia care policy regarding regional anesthesia.

The Hospital provided no policies to indicate Cesarean section patients received the same post-anesthesia standard of care as patients in the Surgical Services patients receiving post-regional anesthesia.

Based on records reviewed and interviews the Medical Staff failed to ensure to the Governing Body organized obstetric services provided to Hospital patients, described clearly with acceptable standards of obstetric care in the Medical Staff Bylaws and Medical Staff Rules & Regulations.

Findings include:

A.) Regarding the failure of the Medical Staff to organize the two Medical Departments providing obstetric care to Hospital patients, the Obstetric and Family Medicine Departments:

The Surveyor interviewed the Chief Medical Officer and the Quality Director at 3:45 P.M. on 9/6/18. The Chief Medical Officer said that the Hospital had two Medical Departments that provided obstetric care to Hospital patients and the two departments were the Family Medicine Department and the Obstetric Department. The Chief Medical Officer said that the Family Medicine Department managed their own privileges and that the Obstetricians needed to manage obstetric medical practice. The Chief Medical Officer said that the American College of Obstetricians and Gynecologists (ACOG, a professional organization of women's health care physicians) had a consulting service and that the Hospital had not yet implemented the ACOG consulting service.

The Surveyor interviewed the Chief Medical Officer and Quality Director at 10:35 A.M. on 8/29/18. The Chief Medical Officer said that the Hospital had two medical cultures of practice regarding obstetric care. The Chief Medical Officer said that, the following the newborn deaths of Patients #1 & #3 in April of 2018, Hospital Executives requested that the Obstetric and Family Medicine Departments develop one Obstetric care guideline for all obstetric patients at the Hospital. The Chief Medical Officer said that Obstetrics and Family Medicine Departments did not develop and did not implement one obstetric care guideline for all Hospital obstetric patients by the time of the Survey.

B.) Regarding the failure of the Medical Staff investigation processes to identify and develop a corrective action plan regarding the Family Medicine Department admitting high-risk obstetric patients to a Family Medicine Physician with extended obstetric privileges prior to the Survey:

The Surveyor interviewed the Quality Director at 12:50 P.M. on 9/6/18. The Quality Director said that a Family Medicine Physician without extended obstetric privileges admitted Patient #6 to the Hospital. The Quality Director said Patient #6 had medical diagnoses of high blood pressure and obesity (indications of possible high-risk pregnancy). The Quality Director said that the Family Medicine Department admitted their obstetric patients to the Family Medicine Physician on-call (that is the Family Medicine Department admitted high-risk obstetric patients to the on-call Family Medicine Physician even if the Hospital credentialed the on-call Family Medicine Physician with extended obstetric privileges). The Quality Director said she did not know if the Family Medicine Department admitted high-risk obstetric patients Family Medicine Physicians without extended obstetric privileges. The Quality Director said that both Family Medicine Physicians with and without extended obstetric privileges cared for Patient #6. The Quality Director said the Hospital transferred Patient #6's baby (Patient #4) with a subgaleal hemorrhage (the life-threatening rupture of a blood vessel from birth trauma causing accumulation of blood between the skull bone and the scalp) to a higher level of care.
The Surveyor interviewed the Chief Medical Officer at 1:30 P.M. on 9/6/18. The Chief Medical Officer said this is something the Hospital would like to do and that the Hospital needed to spell this out better (that is, the Hospital would like to admit high-risk obstetric Family Medicine patients to Family Medicine Physicians with extended obstetric privileges however, the Hospital needed to define this process better.) The Chief Medical Officer said the Hospital would like Family Medicine to admit high-risk obstetric patients to a Family Practice Physician with extended obstetric privileges and that it would be effective as of today (9/6/18, during the Survey).

Based on interviews and record review the Hospital failed ensure the Medical Record Services had a system or procedure for clear and completed Neonatal Resuscitation Records, consistent with Hospital policy.

Findings include:

The Hospital policy titled, Form and Format of the Medical Record, dated 8/18, indicated that the Health Information Services Committee of the Medical Staff and or the Pharmacy and Therapeutics Committee had the responsibility of reviewing and approving new and revised forms. The Form and Format of the Medical Record policy indicated the Director of Health Information Management and Materials Management had oversight of the finalized forms for distribution, forms control and management. The Form and Format of the Medical Record policy did not indicate if a form required a document, policy, guideline as instruction on the use of the form.

The form titled Neonatal Resuscitation Record indicated a blank form, copied and with missing information on the left side and bottom of the page. The Neonatal Resuscitation Record did not indicate that the Medical Records Department approved the form to be included in a patient's permanent medical record.

The Surveyor interviewed Special Care Nursery Nurses #1 & #2 at 3:05 P.M. on 9/11/18 during tours of the Maternal Newborn Services. Special Care Nursery Nurses #1 & #2 said nurses documented medications administered during a neonatal resuscitation on the Neonatal Resuscitation Record. Special Care Nursery Nurses #1 & #2 said the Hospital did not consider the Neonatal Resuscitation Record as a doctor's order sheet for the administration of the resuscitation medications. Special Care Nursery Nurses #1 & #2 said that the Hospital filed the Neonatal Resuscitation Record in the newborn's medical record.

The Hospital provided no documentation to indicate the Hospital's intended use of the Neonatal Resuscitation Record. The Hospital provided no documentation to indicate if the resuscitation medications documented were Provider verbal orders and that a Provider signature on the Neonatal Resuscitation Record indicated the Provider's authentication of the order for the resuscitation medication.

The Surveyor interviewed the Quality Director at 3:05 P.M. on 9/11/18 during tours of the Maternal Newborn Services. The Quality Director said the Hospital's Quality Assurance & Performance (QAPI) activities did not review neonatal resuscitations. The Quality Director said the Hospital did not have a process similar to the Hospital's review of adult resuscitations for neonatal resuscitations.