HospitalInspections.org

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

Findings included:


The Governing Body failed for one (Patient #1) of ten sampled patients to ensure that Allied Professional Staff provided quality patient care in accordance within granted privileges and criteria that described Allied Professional Staffs' scope of practice for those granted privileges.

Refer to TAG: A-0049.

The Governing Body failed for one (Patient #1) of ten sampled patients to ensure that the Hospital had clear and defined scopes of practice for Allied Professional Staff privileged to provide care to Hospital patients.

Refer to TAG: A-0057.

The Governing Body failed for one (Patient #10) of ten sampled patients to ensure Emergency Department (ED) compliance with policies and procedures governing obstetric care provided in the ED and ensure responsibility of the Medical Staff in accordance with Emergency Services Condition of Participation TAG: 0014.

Refer to TAG: 0092.

Based on records reviewed and interviews the Governing Body failed for one (Patient #1) of ten sampled patients to ensure that Allied Professional Staff provided quality patient care in accordance within granted privileges and criteria that described Allied Professional Staffs' scope of practice for those granted privileges.

Findings included:

1.) The History & Physical, dated at 2:05 P.M. on 6/24/17, indicated Patient #1 was admitted to the Hospital with a diagnosis of oligohydramnios (an obstetric diagnosis of deficient volume of amniotic fluid).

The History & Physical, dated at 2:05 P.M. on 6/24/17 and Intrapartum Notes, dated 6/24/17 at 2:57 P.M. through 6/26/17 at 8:28 A.M., indicated a Certified Nurse Midwife (Allied Professional Staff) delivered Patient #1's obstetric care.

The OBGYN Outpatient, Observation Treatment Record, dated 6/24/17 not timed, indicated the Hospital admitted Patient #1 for cervical ripening (induction of labor).

The Operative Report, dated 6/26/17 at 8:55 P.M., indicated Patient #1 had a Cesarean birth for oligohydramnios, prolonged rupture of amniotic membranes and fetal intolerance to labor. The Operative Report indicated postoperative diagnoses including chorioamnionitis (an amniotic membrane bacterial infection in the setting of amniotic membrane rupture).

The Discharge Summary, dated 6/26/17 at 7:53 P.M., indicated physicians performed a hysterectomy (surgical removal of the uterus), Patient #1 received massive blood product transfusions and was transferred to the Intensive Care Unit (ICU). The Discharge Summary indicated that Patient #1 had heart beat rhythm changes that developed into asystole (flat line). The Discharge Summary indicated that, despite maximum Advance Cardiac Life Support (ACLS) resuscitative efforts, a physician pronounced Patient #1 dead. The Discharge Summary indicated Patient #1's death from chorioamnionitis.

2.) The Medical Staff Bylaws, dated 4/27/17, indicated the Medical Staff organized and governed Allied Professional Staff in accordance with Allied Professional Staff Rules and Regulations. The Medical Staff Bylaws indicated Allied Professional Staff Rules and Regulations promulgated (stated) as necessary to define criteria for appointment to the Allied Professional Staff and for the delineation of clinical privileges of Allied Professional Staff members.

The Allied Professional Rules and Regulations, dated 2/26/17, indicated the Board of Directors (Governing Body) recognized Allied Professional Staff included Certified Registered Nurse Midwives, Chiropractors, Mental Health Clinicians, Nurse Practitioners, Physician Assistants, Psychologists and Certified Nurse Anesthetists in the Allied Professional Staff Category. The Allied Professional Rules and Regulations indicated credentialing procedures for Allied Professional Staff included documentation of professional experience, background, training, ability, competence character and judgement with sufficient detail to satisfy the criteria applicable to such category of Allied Professional Staff. The Allied Professional Rules and Regulations indicated that the Medical Executive Committee set forth criteria for such category of Allied Professional Staff to include qualifications, scope of duties, scope of clinical privileges, scope of responsibilities and specific procedures, which Allied Professional Staff Members in such category were, authorized to perform.

The Hospital provided no documentation to indicate the Medical Executive Committee set forth criteria applicable for each category of Allied Professional Staff that included qualifications, scopes of duties, clinical privileges, responsibilities and specific procedures which Allied Professional Staff Members in each category were recommended to the Board of Directors to perform and to be adopted by the Hospital's Governing Body.

The Surveyor interviewed the Chief Medical Officer, at 9:30 A.M. on 7/20/18 and 11:30 A.M. on 8/1/18. The Chief Medical Officer said that the Medical Staff did not recommend to the Governing Body for approval of Allied Professional Staff's scope of duties, scope of clinical privileges, scope of responsibilities including specific procedures.

Based on records reviewed and interviews the Chief Executive officer failed for one (Patient #1) of ten sampled patients to ensure that the Hospital had clear and defined scopes of practice for Allied Professional Staffs' privileged to provide care to Hospital patients.

Findings included:

The Medical Staff Bylaws, dated 4/27/17, indicated that the Medical Staff organized and governed Allied Professional Staff in accordance with Allied Professional Staff Rules and Regulations that defined criteria for appointment to the Allied Professional Staff and for the delineation of clinical privileges of Allied Professional Staff members.

The Allied Professional Rules and Regulations, dated 2/26/17, indicated that the Medical Executive Committee set forth criteria for such category of Allied Professional Staff to include qualifications, scope of duties, scope of clinical privileges, scope of responsibilities and specific procedures that Allied Professional Staff Members were authorized to perform.

The Hospital provided no documentation to indicate the Medical Executive Committee set forth criteria applicable for each category of Allied Professional Staff that included qualifications, scopes of duties, clinical privileges, responsibilities and specific procedures which Allied Professional Staff Members were recommended to the Board of Directors to perform and adopted by the Hospital's Board of Directors.

The Surveyor interviewed the Chief Medical Officer, at 9:30 A.M. on 7/20/18 and 11:30 A.M. on 8/1/18. The Chief Medical Officer said that the Medical Staff did not recommend to the Governing Body approval of Allied Professional Staff's scope of duties.

Based on records reviewed and interviews the Chief Executive Officer failed for one (Patient #10) of ten sampled patients to ensure Emergency Department (ED) compliance with policies and procedures governing obstetric care provided in the ED and ensure responsibility of the Medical Staff in accordance with Emergency Services Condition of Participation TAG: A-0014.

Findings included:

The policy titled Pregnant Patients, Triage and Care of in Emergency Department, dated 4/20017, indicated that ED Registration Staff received the patient and placed an identification band on the patient, the ED Triage Nurse established the patients's gestational age and determined the chief complaint, documented a narrative note in the patient's medical record and initiated the Standard Order Set to transfer the patient to the Birthing Center.

The OBGYN Outpatient, Observation Treatment Record, dated 6/22/18, indicated a pregnant woman at 34 weeks gestation (40 is full-term), Patient #10, arrived to the Birthing Center in a wheel chair from the ED for evaluation of spontaneous rupture of membranes. Medical Record Review did not indicate that the Hospital registered Patient #10 and did not indicate any evaluation by the Triage Nurse.

The History & Physical, dated two days later at 6:17 A.M. on 6/25/18, indicated Patient #10 as admitted to the Hospital with chorioamnionitis (an amniotic membrane bacterial infection) and to unstable for transport to a higher level of care obstetric hospital. The Nursing Discharge Note, dated at 9:00 A.M. 6/25/18, indicated Patient #10 as transferred to a higher level of care obstetric hospital.

The Surveyor interviewed the Chief Medical Officer, Birthing Center Nurse Manager and the Medical Record Nurse Navigator, at 11:20 A.M. on 7/31/18. The Medical Record Nurse Navigator said Patient #10's Medical Record did not contain registration information and Patient #1's Medical Record did not contain nursing or provider note(s) for the visit of 6/22/18.

The Surveyor interviewed the Covering Nurse Director of the ED and the ED Triage Nurse, at 10:30 A.M. on 8/1/18. The ED Triage Nurse said approximately 90% of the time the ED registered obstetric patients and did not know why the other 10% were not registered consistent with Hospital policy.

The Hospital was out of compliance for the Quality Assessment & Performance Condition of Participation.

Findings included:

Based on records reviewed and interviews the Hospital failed for seven (Patients #1, #2, #3, #4, #5, #7 and #10) of ten patients sampled to ensure Quality Assessment & Performance activities were thorough and preventative activities were implemented that included learning throughout the Hospital as appropriate, after Patient #1's death.

Refer to TAG: A-0286.

Based on records reviewed and interviews the Hospital failed for seven (Patients #1, #2, #3, #4, #5, #7 and #10) of ten sampled patients to ensure Quality Assessment & Performance Improvement (QAPI) activities were thorough and preventative activities were implemented that included learning opportunities for all relevant staff caring for obstetric patients throughout the Hospital, following Patient #1's death.

Findings included:

The Quality Management Plan, dated 2018, indicated that the appropriate Department was responsible for patient event investigations and the quality improvement team was responsible to ensure corrective and preventive actions were carried out and measured for effectiveness.

The History & Physical, dated at 2:05 P.M. on 6/24/17, indicated Patient #1 was admitted to the Hospital with a diagnosis of oligohydramnios [deficient volume of amniotic fluid associated with maternal and fetal complications, rupture of the membranes is a cause of oligohydramnios, typically diagnosed by ultrasound and described as Amniotic Fluid Index (AFI) less than 5)].

The Ultrasound Report, dated 6/24/17 at 1:08 P.M. indicated Patient #1 with an AFI of 2 centimeters suggestive of oligohydramnios.

1.) The following regarding QAPI activities failure to implement Quantitative Blood Loss measurement practices in accordance with the Hospital Corrective Action Plan after Patient #1's death and in the setting of postpartum hemorrhage:

The Policy titled Maternal Hemorrhage Protocol, dated 7/2017, indicated blood loss was quantified (measured and not estimated).

The Association of Women's Health, Obstetric and Neonatal (AWHONN, Obstetric Nursing Professional Organization) Postpartum Hemorrhage Project (2017) indicated Maternal Morbidity & Mortality from postpartum hemorrhage as a leading cause of pregnancy-related complications. The AWHONN Nursing Practice Brief, dated 2014, indicated that they recommended cumulative blood loss be formally measured or quantified after every birth.

The Operative Report, dated 6/26/17 at 8:55 P.M., indicated Patient #1 had a Cesarean birth with an estimated blood loss of 600 milliliters (mL).

The Labor and Delivery Summary, dated 6/26/17, indicated that the Registered Nurse did not document blood loss.

The Discharge Summary, dated 6/26/17 at 7:53 P.M., indicated physicians brought Patient #1 back to the Operating Room, performed a hysterectomy and Patient #1's estimated blood loss as 2500 mL and received massive blood product transfusions for postpartum hemorrhage.

The Surveyor interviewed the Chief Medical Officer (CMO) and Obstetric Educator, at 12:30 P.M. on 7/19/18. The CMO said that the Hospital Investigation discovered that staff measured Patient #1's blood loss as Estimated Blood Loss and not Quantitative Blood Loss (accurate measurement).

The Obstetric Educator said that the Hospital did not formally implement processes to change the practice from Estimated Blood Loss to Quantitative Blood Loss (Patient #1's death was 6/2017) and the Survey commenced 7/19/17, one year after Patient #1's death.

Medical Record Review indicated staff estimated blood loss in four patients (Patients #2, #3, #4 & #5) with hemorrhage in a total of ten sampled patients.

The Labor & Delivery Summary, dated 4/18/18, indicated staff estimated Patient #2's blood loss.

The Provider Postpartum Note, dated 6/28/18, indicated staff estimated Patient #3's blood loss.

The Operative Note, dated 10/6/17, indicated staff estimated Patient #4's blood loss.

The Emergency Department Visit Summary, dated 5/24/18 and 5/25/18, indicated staff did not estimate and staff did not quantify Patient #5's vaginal blood loss regarding delayed postpartum bleeding.

The Hospital provided no documentation to indicate implementation of Quantitative Blood Loss in the Emergency Department as a learning activity for obstetric patients presenting in the ED.

2.) The following regarding the failure of QAPI activities to analyze pain management:

The Hospital policy titled Pain Management in Laboring Women, dated 10/2012, indicated staff completed comprehensive pain evaluation on admission, at a minimum of every 4 hours, with known painful procedures using rating scale (1-10 score).

The Surveyor interviewed the Birthing Center Nurse Manager at 11:20 A.M. on 7/31/18. The Birthing Center Nurse Manager said nursing evaluation of obstetric patient pain was continuous.

The OBGYN Outpatient, Observation Treatment Record, dated 6/24/17 not timed, indicated the Hospital admitted Patient #1 for cervical ripening (induction of labor). The OBGYN Outpatient, Observation Treatment Record indicated a Registered Nurse documented painful vaginal examination. The OBGYN Outpatient, Observation Treatment Record did not indicate the nurse used a pain score rating scale.

Intrapartum Note, dated 6/24/17 at 2:57 P.M. and written by a Provider (CNM), indicated Patient #1 as crampy with the Foley bulb (catheter inserted into cervix to induce labor). The Intrapartum Note did not indicate the CNM used a pain score rating scale.

Intrapartum Note, dated 6/25/17 at 3:58 A.M. and written by a Provider (CNM), indicated uterine contractions palpated as mild. Intrapartum Note, dated 6/25/17 at 4:32 P.M. and written by a Provider (CNM), indicated Patient #1 as more uncomfortable (undefined). The Intrapartum Notes did not indicate the CNM used a pain score rating scale.

The Labor Flow Sheet, dated 6/25/17 at 4:30 P.M., indicated Patient #1 received nitrous oxide (medication for pain) for pain management. The Labor Flow Sheet did not indicate the nurse used a pain score rating scale before and after the pain medication administration.

Intrapartum Note, dated 6/25/17 at 8:28 P.M. and written by a Provider (CNM), indicated Patient #1 as breathing hard with contractions, working hard and using nitrous oxide with some benefit. The Intrapartum Note did not indicate the CNM used a pain score rating scale.

The Provider Order Summary indicated a physician ordered, at 2:15 P.M. on 6/26/17, Fentanyl (narcotic) 50 mcg to be administered for a severe pain score of 7-10 and ordered Fentanyl 25 mcg to be administered for a moderate pain score of 4-6.

Intrapartum Note, dated 6/26/17 at 2:20 A.M. and written by a Provider (CNM), indicated Patient #1 received four doses of Fentanyl and another dose of Fentanyl before a Sterile Vaginal Examination (SVE) to lessen discomfort of the SVE.

Intrapartum Note, dated 6/26/17 at 3:38 A.M. and written by a Provider (CNM), indicated Patient #1 received Fentanyl dose number five before a SVE.

The Anesthesia Record, dated 6/26/17, indicated an Anesthesiologist, at 7:00 A.M., performed an epidural procedure (catheter placed in a spinal space for Patient #1's pain management).

Intrapartum Note, dated 6/26/17 at 8:28 A.M. and written by a Provider (CNM), indicated a physician examined Patient #1 and placed an Intrauterine Pressure Catheter (IUPC, possible painful procedure).

Labor Flow Sheets, dated 6/24/17 through 6/26/17, did not indicate a pain score upon Patient #1's admission to the Labor Unit on 6/24/17. The Labor Flow Sheet did not indicate nurses evaluated Patient #1's pain level routinely at regular intervals in accordance with the Hospital Pain Management in Laboring Women policy. The Labor Flow Sheets did not indicate nurses evaluated Patient #1's pain and documented the score with the administration of Nitrous Oxide, at 4:30 on 6/25/17, for pain management. The Labor Flow Sheet, dated 6/24/17 through 6/25/17, did not indicated nurses evaluated and documented Patient #1's pain score until Patient #1 received Fentanyl at 8:55 P.M. on 6/26/17. Labor Flow Sheets did not indicate nurses evaluated and documented Patient #1's pain score with known pain-producing procedures, Foley catheter inserted into the uterus to induce labor at 1:53 P.M. on 6/24/17, sterile vaginal examinations, Intrauterine Pressure Catheter (IUPC) placement at 12:45 P.M. on 6/25/17, and nurses did not evaluate Patient #1's pain score, at 6:30 A.M. on 6/26/17, with the epidural catheter insertion procedure for pain management. The Labor Flow Sheets (a paper document) did not include an area (column with vital signs) readily recognizable to document and monitor changes in pain scores.

3.) The following regarding QAPI activities failure to analyze temperature monitoring:

A.) The Surveyor interviewed the Birthing Center Nurse Manager at 11:20 A.M. on 7/31/18. The Birthing Center Nurse Manager said that the Hospital Standard of Care for temperature monitoring was every one hour with ruptured membranes.

The Birthing Center Admission (Blank Form) indicated the Hospital Standard of Care was for Patient temperature monitoring every one hour after ruptured membranes.

Labor Flow Sheet, dated 6/25/17 page 5 and the Labor and Delivery Summary, dated 6/26/17, indicated Patient #1's spontaneous rupture of membranes at 2:00 A.M. on 6/25/17.

Labor Flow Sheets, dated 6/25/17 through 6/26/17, did not indicate temperature monitoring was every one hour after ruptured membranes.

Labor Flow Sheets did not indicate staff monitored Patient #1's temperature at 3:00 A.M., 5:00 A.M., 6:00 A.M., 7:00 A.M., 8:00 A.M. and 9:00 A.M. on 6/25/17.

Labor Flow Sheet, dated 6/26/17 at 7:00 A.M., indicated Patient #1 with a temperature of 100.2. The Labor Flow Sheet did not indicate staff monitored at 8:00 A.M. Patient #1's temperature.

B.) The Surveyor interviewed the Birthing Center Nurse Manager at 11:00 A.M. on 8/31/18. The Birthing Center Nurse Manager said the Provider did not update Patient #1's temperature monitoring orders from every 4 hours to hourly when Patient #1 ruptured membranes.

The document titled Vital Signs, dated 6/24/(year not indicated) at 12:40 P.M. indicated a Provider order to nursing staff to monitor Patient #1's temperature every 4 hours. Patient #1's medical record indicated no Provider order to monitor temperature hourly consistent with the Hospitals' Standard of Care.

4.) The following regarding QAPI activities failure to include education to relevant staff throughout the Hospital.

The Emergency Department Visit Summary, dated 5/24/18 and 5/25/18, indicated staff did not estimate and staff did not quantify Patient #5's vaginal blood loss regarding delayed postpartum bleeding.

The document titled Maternal Early Warning Signs Extension Project Plan, dated 7/19/18 during the Survey, indicated the Hospital extended the Maternal Early Warning Signs Project to the Emergency Department staff, Post Anesthesia Care Unit staff, the Intensive Care Unit and Operating Room Staff.

The Surveyor interviewed the Chief Quality Officer, on 7/20/18. The Chief Quality Officer said that the Hospital implemented the Maternal Early Warning Signs Project to the Emergency Department, Post Anesthesia Care Unit, Intensive Care Unit and Operating Room staff.

5.) The following regarding a verbal order and quality monitoring.

The Hospital policy titled Telephone Orders, Taking and Read Back, dated 6/2016, indicated all telephone orders were signed by the Provider within 48 hours of the telephone order.

The Physician's Order Sheet, dated 7/25/17, indicated a Provider did not sign a telephone order for Patient #7.

The following regarding Emergency Department to Birthing Center transfer.

The OBGYN Outpatient, Observation Treatment Record, dated 6/22/18, indicated Patient #10 arrived to the Birthing Center in a wheel chair from the Emergency Department. There was no documentation of Nursing Evaluation or Provider Evaluation in the Emergency Department.

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

Findings included:

Based on records reviewed and interviews the Medical Staff failed for one (Patient #1) of ten sampled patients to ensure determination of eligibility for appointment by the Governing Body to the Medical Staff, Allied Professional Staff according to specified Medical Staff Bylaws and Medical Staff Rules & Regulations for the quality of medical care provided to patients by the Hospital.

Refer to TAG: A-0339.

Based on records reviewed and interviews the Medical Staff failed to ensure quality of medical care provided to Patient #3 in the setting of a postpartum hemorrhage requiring a Bakri Balloon (device) to manage bleeding.

Refer to TAG: A-0347.

Based on records reviewed and interviews the Medical Staff failed for one (Patient #1) of ten sampled patients to ensure a statement of the duties, that included clear, specific and complete listing of medical staff privileges granted for Allied Professional Staff in the Hospital Medical Staff Bylaws for the quality of medical care provided to patients by the Hospital.

Refer to TAG: A-0355.

Based on records reviewed and interviews the Medical Staff failed for one (Patient #1) of ten sampled patients to ensure Allied Health Professionals (non-physician practitioners) were determined eligible for appointment by the Governing Body to the Medical Staff for quality medical care provided to patients by the Hospital, according to specified Medical Staff Bylaws and Medical Staff Rules & Regulations that included scopes of practice, duties, responsibilities and procedures.

Findings included:

1.) The History & Physical, dated at 2:05 P.M. on 6/24/17, indicated Patient #1 was admitted to the Hospital with a diagnosis of oligohydramnios [deficient volume of amniotic fluid associated with maternal and fetal complications, rupture of the membranes is a cause of oligohydramnios, typically diagnosed by ultrasound and described as Amniotic Fluid Index (AFI) less than 5)]. The History & Physical indicated Certified Nurse Midwife (CNM) and Physician communication regarding Patient #1.

The Ultrasound Report, dated 6/24/17 at 1:08 P.M. indicated Patient #1 with an AFI of 2 centimeters suggestive of oligohydramnios.

The OBGYN Outpatient, Observation Treatment Record, dated 6/24/17 not timed, indicated the Hospital admitted Patient #1 for cervical ripening (induction of labor).

The History & Physical, dated at 2:05 P.M. on 6/24/17 and Intrapartum Notes dated 6/24/17 at 2:57 P.M. through 6/26/17 at 8:28 A.M., indicated a Certified Nurse Midwife (an Allied Professional Staff) provided Patient #1's obstetric care.

Intrapartum Note, dated 6/24/17 at 2:57 P.M. and written by a Provider (CNM), indicated Patient #1 as crampy (common sign) with the Foley bulb (catheter inserted into cervix to induce labor) for oligohydramnios. The Intrapartum Note, indicated Patient #1's baby with no further heart rate decelerations (possible sign of fetal distress). The Intrapartum Note indicated Certified Nurse Midwife (CNM) and Physician communication regarding Patient #1.

Intrapartum Note, dated 6/24/17 at 7:24 P.M. and written by a Provider (CNM), indicated the baby as having one repeat episode of a heart rate deceleration.

Intrapartum Note, dated 6/25/17 at 3:58 A.M. and written by a Provider (CNM), indicated uterine contractions palpated as mild.

Intrapartum Note, dated 6/25/17 at 11:28 A.M. and written by a Provider (CNM), indicated Patient #1 had obvious thick yellow (possible sign of infection) meconium (newborn first stool) on a (sanitary) pad that indicated obvious rupture of membranes. The Intrapartum Note indicated external monitoring (external medical device used to measure tension across the abdominal wall and detect contraction frequency and duration) of the fetal heart rate and uterine contractions were difficult to monitor and there was some lost information. The Intrapartum Note indicated the CNM discussed internal monitoring [an intrauterine pressure catheter (IUPC) is a device placed into the amniotic space to measure the strength of uterine contractions] with Patient #1. The Intrapartum Note did not indicate communication with a physician of Patient #1's possible changes in condition, difficulties with monitoring the fetal heart rate and uterine activity or for a change in plan of care.

The textbook of Neonatal Resuscitation, 7th edition, indicated the presence of meconium stained amniotic fluid might indicate fetal distress.

Intrapartum Note, dated 6/25/17 at 4:32 P.M. and written by a Provider (CNM), indicated Patient #1 as more uncomfortable (undefined). The Intrapartum Note indicated a brief period of fetal heart rate decelerations. The Intrapartum Note indicated that the IUPC was not able to be placed and the electronic fetal monitor did not record uterine contraction strength or timing. Intrapartum Note indicated CNM communication with a Physician regarding Patient #1.

Intrapartum Note, dated 6/25/17 at 8:28 P.M. and written by a Provider (CNM), indicated Patient #1 as breathing hard with contractions, working hard and using nitrous oxide (medication for pain management) with some benefit. The Intrapartum Note indicated that Patient #1's vagina, cervix felt very warm, her temperature was 98.3 degrees Fahrenheit (normal) with a plan to watch (monitor) her temperature and discuss options for pain relief.

The Surveyor interviewed Certified Nurse Midwife #1 at 1:00 P.M. on 7/31/18. CNM #1 said yellow meconium was an abnormal finding and no one knew how long Patient #1 had ruptured amniotic fluid membranes. CNM #1 said she did not suspect infection although was alerted to infection. CNM #1 said she did not order additional testing to determine whether Patient #1 had an infection. CNM #1 said uterine tenderness was a sign of uterine infection. CNM #1 said Patient #1 required just monitoring. CNM #1 said that Patient #1 did not indicate a need for a Medical Doctor (MD) to examine Patient #1 because the CNM and MD were in discussion regarding Patient #1's plan of care. CNM #1 said Patient #1's vagina was very warm, that she (the CNM) was concerned and watching (monitoring) Patient #1 for fever (high temperature, being 100.4 degrees Fahrenheit).

Labor Flow Sheets, dated 6/24/17 through 6/26/17, indicated Patient #1 did not have a fever; however, laboratory reports did not indicate that the CNM ordered blood testing to evaluate maternal infection with possible signs of fetal distress, yellow mucous discharge and yellow meconium stained amniotic fluid and that the CNM documented Patient #1's vagina was warm with a progression of pain management interventions (possible signs of infection).

Intrapartum Notes and Labor Flow Sheets, dated 6/24/17 through 6/26/17, did not indicate uterine evaluation for tenderness (a sign of infection).

Medical Staff Bylaws, dated 4/27/17, and Allied Professional Rules and Regulations, dated 2/26/17, did not indicate a policy, procedure, guideline or guidance for CNM and MD consultation related to changes in patient condition, changes in a plan of care or patient transfer of care for CNM to MD care.

Intrapartum Note, dated 6/26/17 at 11:46 A.M. and written by a Provider (first documentation by a Medical Doctor and approximately 46 hours after Patient #1's admission for induction of labor due to oligohydramnios), indicated Patient #1 with prolonged rupture of membranes for greater than 24 hours with meconium stained amniotic fluid.

The Surveyor interviewed the Chief Medical Officer (CMO) at 11:20 A.M. on 7/31/18. The CMO said that the first MD note was at 11:46 A.M. on 6/26/17.

Intrapartum Note, dated 6/26/17 at 12:35 P.M. and written by a Provider (Medical Doctor, MD), indicated a plan for Cesarean birth because the baby had persistent heart rate decelerations.

The Operative Report, dated 6/26/17, indicated Patient #1 had a Cesarean birth, and severe chorioamnionitis (an amniotic membrane bacterial infection in the setting of amniotic membrane rupture). The Operative Report indicated Patient #1 was taken to the recovery room.

The Discharge Summary, dated 6/26/17, indicated that pus was in her abdomen. The Discharge Summary indicated, shortly after the Cesarean section, that Patient #1 began having sustained vaginal bleeding, hypotension with blood pressures in the 60's systolic (very low) and tachycardia (high heart rate) to 160 beats per minute. The Discharge Summary indicated physicians brought Patient #1 back to the Operating Room, placed a central (into a large vein) intravenous line and performed a hysterectomy. The Discharge Summary indicated Patient #1's EBL as 2500 mL, received massive blood product transfusions including three Liters of crystalloid (type of intravenous fluid), 4 Units of packed red blood cells and 1 unit of Fresh Frozen Plasma (FFP) and transferred to the Intensive Care Unit (ICU). The Discharge Summary indicated that at approximately 5:00 P.M. Patient #1 had a heart beat rhythm change that developed into pulseless ventricular tachycardia (life-threatening heart rhythm) then asystole (flat line). The Discharge Summary indicated that despite maximum Advance Cardiac Life Support resuscitative efforts for 50 minutes a physician pronounced Patient #1 dead at 6:32 P.M. The Discharge Summary indicated Patient #1's death from severe metabolic acidosis due to overwhelming sepsis secondary to chorioamnionitis.

2.) The Medical Staff Bylaws, dated 4/27/17, indicated the Medical Staff organized and governed Allied Professional Staff in accordance with Allied Professional Staff Rules and Regulations.

The Allied Professional Rules and Regulations, dated 2/26/17, indicated the Board of Directors recognized Allied Professional Staff (APS) included Certified Registered Nurse Midwives, Chiropractors, Mental Health Clinicians, Nurse Practitioners, Physician Assistants, Psychologists and Certified Nurse Anesthetists in the Allied Professional Staff Category.

The Hospital provided no documentation to indicate the Allied Health Professionals (non-physician practitioners) were determined eligible for appointment by the Governing Body to the Medical Staff for quality medical care provided to patients by the Hospital, according to specified Medical Staff Bylaws and Medical Staff Rules & Regulations that included scopes of practice, duties, responsibilities and procedures.

3.) The document titled Appointment, Reappointment Recommendations Flow Sheet, dated as copied 7/27/18, indicated a member of the Board of Directors (Governing Body) failed to authenticate (sign) the Appointment, Reappointment Recommendations Flow Sheet for Certified Nurse Midwife (CNM) #1. The Appointment, Reappointment Recommendations Flow Sheet indicated a blank signature line for the Board of Director authentication and dated as 7/26/18.

Based on records reviewed and interviews the Medical Staff failed to ensure quality of medical care provided to one (Patient #3) in a sample of ten sampled patients in the setting of a postpartum hemorrhage requiring a Bakri Balloon (device to manage bleeding) placement.

Findings included:

The policy titled Bakri Balloon, Assisting with Insertion, dated 1/2018, indicated an ultrasound could be useful to confirm correct placement in the uterine cavity.

Association of Women's Health, Obstetric and Neonatal (AWHONN, Obstetric Nursing Professional Organization) Postpartum Hemorrhage Project (2017) indicated Maternal Morbidity & Mortality from postpartum hemorrhage as a leading cause of pregnancy-related complications.

The AWHONN Nursing Practice Brief, dated 2014, indicated women die form obstetric hemorrhage because effective interventions were not initiated early enough.

The Provider Postpartum Note, dated 6/28/18, indicated a Provider provided Patient #3 with a Bakri Balloon for postpartum hemorrhage.

Medical Record review indicated no documentation that an ultrasound evaluation was performed to confirm correct placement of the Bakri Balloon in the uterine cavity.

The Surveyor interviewed the Birthing Center Nurse Manager and Medical Record Nurse Navigator, during the Medical Record Review. The Nurse Manager said that an ultrasound procedure was not performed to confirm correct placement of the Bakri Balloon in the uterine cavity.

Based on records reviewed and interviews the Medical Staff failed for one (Patient #1) to ensure a statement of the duties that included clear, specific and complete listing of medical staff privileges granted for Allied Professional Staff in the Hospital Medical Staff Bylaws for the quality of medical care provided to patients by the Hospital.

Findings included:

The Medical Staff Bylaws, dated 4/27/17, indicated the Medical Staff organized and governed Allied Professional Staff in accordance with Allied Professional Staff Rules and Regulations. The Medical Staff Bylaws indicated Allied Professional Staff Rules and Regulations promulgated (stated) as necessary to define criteria for appointment to the Allied Professional Staff and for the delineation of clinical privileges of Allied Professional Staff members. The Medical Staff Bylaws indicated the Medical Executive Committee reviewed at least annually the Allied Professional Staff Rules and Regulations. The Medical Staff Bylaws indicated these bylaws shall be reviewed at least biennially (every 2 years) by the Bylaws Committee.

The Allied Professional Rules and Regulations, dated 2/26/17, indicated the Board of Directors recognized Allied Professional Staff (APS) and included Certified Registered Nurse Midwives, Chiropractors, Mental Health Clinicians, Nurse Practitioners, Physician Assistants, Psychologists and Certified Nurse Anesthetists in the Allied Professional Staff Category. The Allied Professional Rules and Regulations indicated credentialing procedures for Allied Professional Staff included documentation of professional experience, background, training, ability, competence character and judgement with sufficient detail to satisfy the criteria applicable to such category of Allied Professional Staff. The Allied Professional Rules and Regulations indicated that the Medical Executive Committee set forth criteria for such category of Allied Professional Staff to include qualifications, scope of duties, scope of clinical privileges, scope of responsibilities and specific procedures, which Allied Professional Staff Members in such category were authorized to perform.

The document titled Department of Obstetrics and Gynecology Division of Midwifery, dated 7/14/00 and presented to the Surveyor at 3:40 P.M. on 7/27/18, indicated a Statement of Understanding and Policies, Procedures and Guidelines. The document, Department of Obstetrics and Gynecology Division of Midwifery, was not a Hospital document, or statement of understanding (contract) with the Hospital, that the Medical Executive Committee set forth to the Hospital Board of Directors as criteria for the category of Allied Professional Staff, Certified Nurse Midwives, as qualifications, scopes of duties, clinical privileges, responsibilities and specific procedures which Certified Nurse Midwives were authorized to perform.

The Surveyor interviewed the Chief Medical Officer (CMO), at 9:30 A.M. & at 11:00 A.M. on 7/20/18. The Chief Medical Officer said that the document titled Department of Obstetrics, Gynecology Division of Midwifery was old and came with the Certified Nurse Midwives (CNM) when the CNM's joined the Hospital Medical Staff. The Chief Medical Officer said that the Medical Staff did not approve and the Governing Body did not approve the document titled Department of Obstetrics, Gynecology Division of Midwifery.

The Surveyor interviewed Certified Nurse Midwife #1 at 1:00 P.M. on 7/31/18. CNM #1 said that the Midwives joined the Hospital Medical Staff in 2001. CNM #1 said that she hoped her Medical Staff privileges included Intrauterine Pressure Catheter insertion and that the Hospital did have policies and procedures to guide this procedure.

The Hospital provided no documentation to indicate the Medical Executive Committee set forth criteria applicable for each category of Allied Professional Staff that included qualifications, scopes of duties, clinical privileges, responsibilities and specific procedures which Allied Professional Staff Members in each category were recommended to the Board of Directors to perform and adopted by the Hospital's Board of Directors.

Based on records reviewed and interview the Medical Staff failed to ensure for one patient (Patient #3) of ten sampled patients that a medical history and physical examination was completed and documented.

Findings included:

Medical Staff Bylaws Rules and Regulations, dated 3/30/17, indicated that the admitting physician completed a complete history and physical examination within 24 hours of admission to the Hospital.

Medical Record review did not indicate that a Provider performed a history and physical examination on Patient #3.

The Surveyor interviewed the Birthing Center Nurse Manager and Medical Record Nurse Navigator during the Medical Record Review. The Nurse Manager and Medical Record Nurse Navigator said that the Patient #3's Medical Record did not indicate a Provider completed a history and physical examination.

Based on records reviewed and interviews the Nursing Service failed for six (Patient #1, #2, #3, #4 & #5 & #10) of ten sampled patients to ensure Nursing Staff met Patient #1's needs for temperature monitoring and pain evaluation, accurate measurement of blood loss and obstetric patient registration in the Emergency Department.

Findings included:

1.) The Surveyor interviewed the Birthing Center Nurse Manager at 11:20 A.M. on 7/31/18. The Birthing Center Nurse Manager said that the Hospital Standard of Care for temperature monitoring was every one hour with ruptured membranes.

The document titled Standard of Care, Practice, Care of the Laboring Patient dated, 4/2000, indicated nursing staff monitored patient temperature hourly after rupture of membranes.

The Birthing Center Admission (Blank Form) indicated the Hospital Standard of Care was for Patient temperature monitoring every one hour after ruptured membranes.

Labor Flow Sheet, dated 6/25/17 page 5 and the Labor and Delivery Summary, dated 6/26/17, indicated Patient #1's spontaneous rupture of membranes at 2:00 A.M. on 6/25/17.

Labor Flow Sheets, dated 6/25/17 through 6/26/17, did not indicate temperature monitoring was every one hour after ruptured membranes. Labor Flow Sheets did not indicate staff monitored Patient #1's temperature at 3:00 A.M., 5:00 A.M., 6:00 A.M., 7:00 A.M., 8:00 A.M. and 9:00 A.M. on 6/25/17. Labor Flow Sheet, dated 6/26/17 at 7:00 A.M., indicated Patient #1 with a temperature of 100.2. The Labor Flow Sheet did not indicate staff monitored at 8:00 A.M. Patient #1's temperature.

2.) The Hospital policy titled Pain Management in Laboring Women, dated 10/2012, indicated staff completed comprehensive pain evaluation on admission, at a minimum of every 4 hours, with known painful procedures using rating scale (1-10 score).

The Surveyor interviewed the Birthing Center Nurse Manager at 11:20 A.M. on 7/31/18. The Birthing Center Nurse Manager said nursing evaluation of obstetric patient pain was continuous.

The OBGYN Outpatient, Observation Treatment Record, dated 6/24/17 not timed, indicated the Hospital admitted Patient #1 for cervical ripening (induction of labor). The OBGYN Outpatient, Observation Treatment Record indicated a Registered Nurse documented painful vaginal examination. The OBGYN Outpatient, Observation Treatment Record did not indicate the nurse used a pain score rating scale.

Labor Flow Sheets, dated 6/24/17 through 6/26/17, did not indicate a pain score upon Patient #1's admission to the Labor Unit on 6/24/17. The Labor Flow Sheet did not indicate nurses evaluated Patient #1's pain level routinely at regular intervals in accordance with the Hospital Pain Management in Laboring Women policy. The Labor Flow Sheets did not indicate nurses evaluated Patient #1's pain and documented the score with the administration of Nitrous Oxide, at 4:30 on 6/25/17, for pain management. The Labor Flow Sheet, dated 6/24/17 through 6/25/16, did not indicated nurses evaluated and documented Patient #1's pain score until Patient #1 received Fentanyl at 8:55 P.M. on 6/26/17. Labor Flow Sheets did not indicate nurses evaluated and documented Patient #1's pain score with known pain-producing procedures, Foley catheter inserted into the uterus to induce labor at 1:53 P.M. on 6/24/17, sterile vaginal examinations, Intrauterine Pressure Catheter (IUPC) placement at 12:45 P.M. on 6/25/17, and nurses did not evaluate Patient #1's pain score, at 6:30 A.M. on 6/26/17, with the epidural catheter insertion procedure for pain management. The Labor Flow Sheets (a paper document) did not include an area (column with vital signs) readily recognizable to document and monitor changes in pain scores.

3.) The Policy titled Maternal Hemorrhage Protocol, dated 7/2017, indicated blood loss was quantified (measured and not estimated).

The Operative Report, dated 6/26/17 at 8:55 P.M., indicated Patient #1 had a Cesarean birth with an estimated blood loss of 600 milliliters (mL).

The Labor and Delivery Summary, dated 6/26/17, indicated that the Registered Nurse did not document blood loss.

The Discharge Summary, dated 6/26/17 at 7:53 P.M., indicated physicians brought Patient #1 back to the Operating Room, performed a hysterectomy and Patient #1's estimated blood loss as 2500 mL and received massive blood product transfusions for postpartum hemorrhage.

The Surveyor interviewed the Chief Medical Officer (CMO) and Obstetric Educator, at 12:30 P.M. on 7/19/18. The Obstetric Educator said that the Hospital did not formally implement processes to change the practice from Estimated Blood Loss to Quantitative Blood Loss (Patient #1's death was 6/2017) and the Survey commenced 7/19/17, one year after Patient #1's death.

Medical Record Review indicated staff estimated blood loss in four patients (Patients #2, #3, #4 & #5) with hemorrhage in a total of ten sampled patients.

The Hospital provided no documentation to indicate implementation of Quantitative Blood Loss in the Emergency Department as a learning activity for obstetric patients presenting in the ED.

4.) The policy titled Pregnant Patients, Triage and Care of in Emergency Department, dated 4/20017, indicated that ED Registration Staff received the patient and placed an identification band on the patient, the ED Triage Nurse established the patients's gestational age and determined the chief complaint, documented a narrative note in the patient's medical record and initiated the Standard Order Set to transfer the patient to the Birthing Center.

The OBGYN Outpatient, Observation Treatment Record, dated 6/22/18, indicated a pregnant woman at 34 weeks gestation (40 is full-term), Patient #10, arrived to the Birthing Center in a wheel chair from the ED for evaluation of spontaneous rupture of membranes. Medical Record Review did not indicate that the Hospital registered Patient #10 and did not indicate any evaluation by the Triage Nurse.

The Surveyor interviewed the Chief Medical Officer, Birthing Center Nurse Manager and the Medical Record Nurse Navigator, at 11:20 A.M. on 7/31/18. The Medical Record Nurse Navigator said Patient #10's Medical Record did not contain registration information and Patient #1's Medical Record did not contain nursing or provider note(s).

The Surveyor interviewed the Covering Nurse Director of the ED and the ED Triage Nurse, at 10:30 A.M. on 8/1/18. The ED Triage Nurse said approximately 90% of the time the ED registered obstetric patients and did not know why the other 10% were not registered consistent with Hospital policy.