HospitalInspections.org

The Condition of Participation Governing Body was out of compliance

Findings included:

The Governing Body failed for 2 of 14 sampled patients (Patient #1 & #2) to ensure that the Medical Staff was accountable to the Governing Body for the quality of obstetric care services provided to patients.

Refer to TAG: 0049

The Governing Body failed for 3 of 14 sampled patients (Patient #1, #2 & #5) to ensure the Chief Executive Officer (President) was responsible for managing the entire Hospital.

Refer to TAG: 0057

The Governing Body failed for 3 of 14 sampled patients (Patient #1, #2 & #5) to ensure that contracted services performed for the Quality Department were safe and effective and subjected to the same hospital-wide Quality Assessment and Performance Improvement (QAPI) evaluation as other services provided directly by the Hospital.

Refer to TAG: 0084

Based on records reviewed and interviews the Governing Body failed for 2 of 14 sampled patients (Patients #1 & #2) to ensure that the Medical Staff was accountable to the Governing Body for the quality of obstetric care services provided to patients.

Findings included:

The following regarding the Governing Body's failure to ensure the Medical Staff was accountable to the Governing Body for the quality of care provided to Patient #1.

The History & Physical, dated at 9:19 A.M. on 2/12/18, indicated Patient #1 was admitted on 2/12/18 for induction of labor. The Death Report, dated 2/13/18, indicated Patient #1's death as 9:12 P.M. on 2/13/18.

Nurse's Note dated at 7:35 A.M. on 2/12/18, indicated Patient #1 had calf pain. Physician Notes and Doctors Orders indicated no documentation for a Doppler ultrasound to determine a deep vein thrombosis (clot in the leg).

Nurses Note, dated 2/12/18 at 10:42 A.M., indicated Patient #1 complained of difficulty breathing. Physician Note, at 11:07 A.M. on dated 2/12/18, indicated Patient #1 had chest pressure. The Physician Note indicated no further cardiac assessment was performed to rule out an acute cardiac event (heart attack) and the Physician Note indicated no documentation of evaluation for transfer to a higher-level center with the appropriate resources and personnel needed to address her increased complexity of care.

The Pre-Anesthesia note, dated at 9:15 A.M. on 2/13/18, indicated the Anesthesiologist documented Patient #1 had a negative cardiac history and endocrine history; the History & Physical, dated at 9:19 A.M. on 2/12/18 and at 7:11 A.M. on 2/12/18 to 7:34 A.M. on 2/12/18, indicated Patient #1 had hypertension prior to admission (and anti-partum hypertension and tachycardia) with pre-eclampsia (toxemia of pregnancy) and significant family history of cardiovascular disease and diabetes.

The Record of the Operation, dated 2/13/18, indicated Patient #1's preoperative diagnosis was a Cesarean section due to failure to progress in labor. The Anesthesia Record, dated 2/13/18, indicated Patient #1 was both hypertensive (high blood pressure) and hypotensive (low blood pressure) during the surgery and the Anesthesiologist administered medications to treat Patient #1's low blood pressure.

Lexicom (medication reference), dated 2018, indicated these medications have cardiovascular effects that may induce symptoms of heart pain and a heart attack.

The Nurse's Note, dated 2/13/18 at 5:00 P.M., indicated, post Cesarean section, an Obstetrician placed a Bakri (mechanical device inserted into the uterus) to manage Patient #1's post-partum hemorrhage. Nurses Notes and Physician Notes, dated 2/13/18, indicated no documentation that an ultrasound was performed to verify correct placement of the Bakri balloon.

The Surveyor interviewed the Obstetric Nurse Educator, at 4:30 P.M. on 4/18/18. The Obstetric Nurse Educator said that an ultrasound was necessary to verify correct placement of the Bakri balloon.

The Surveyor interviewed the Obstetric Medical Director, at 7:58 A.M. on 4/25/18. The Obstetric Medical Director said that an ultrasound was not preformed to verify correct placement of the Bakri balloon. The Physician Notes, dated 2/13/18, indicated no documentation of fluid or blood product replacement for maternal hemorrhage prior to Patient #1's cardiopulmonary arrest and death.

The Surveyors interviewed Registered Nurse (RN) #1, at 8:20 A.M. on 4/18/18. RN #1 said when Patient #1 had breathing problems, Patient #1 said both "I am having difficulty breathing and I am having hard time breathing".

Physician Notes and Doctors Orders, dated 2/12/18 to 2/13/18, indicated no documentation of diagnostic tests, further than a chest x-ray obtained at 7:01 P.M. on 2/13/18, to exclude medical diseases related to Patient #1's complaints of shortness of breath and chest pain on 2/12/18 and 2/13/18.

The Emergency Response Team (RRT) Record, dated at 8:26 P.M. on 2/13/18, indicated Patient #1 had a cardiopulmonary arrest (ceasing of a heartbeat and breathing) at 8:32 P.M. on 2/13/18.

The Nurse's Note, dated 2/13/18 at 6:25 P.M., indicated Patient #1 was nauseated and vomiting since the placement of the Bakri balloon and complaining of midline chest pain and burning feelings.

The Medication Administration Record, dated 2/13/18, indicated anti-nausea medications, medications for indigestion and Tums were ordered, but without a documented response (relief or continuation of the midline chest pain and burning feelings symptoms).

A portable Chest X-Ray was ordered at 2/13/18 at 7:01 P.M. for Patient #1's chest pain, findings were no active process in the chest.

Physician Notes and Doctors orders indicated no documentation for an Electro-Cardiogram (ECG) even with Patient #1's complaint of chest pain.

The Hospital policy titled Maternal Transfer to Baystate Medical Center, dated 6/2015, indicated the decision is made by the attending Physician or Certified Nurse Midwife in consultation with a physician to transfer patients because of premature labor, premature rupture of membranes, early gestational age, severe toxemia, severe diabetes, or any High Risk patient.

Patient #1's Physician Notes, dated 2/12/18 through 2/13/18, indicated no indication to transfer Patient #1 to a higher-level center with the appropriate resources and personnel needed to address her increased complexity of care in accordance with Hospital policy.

The Surveyor interviewed the Obstetric Medical Director at 3:30 P.M. on 4/4/18. The Obstetric Medical Director said Patient #1's care was not Peer Reviewed. The Obstetric Medical Director said that there were no glaring medical findings.

The following regarding the Governing Body's failure to ensure the Medical Staff appropriately arranged for Patient #2, an obstetric high-risk patient's, transfer to a higher-level center in response to her declining condition and her increased complexity of care consistent with Hospital policy and Obstetric Standard of Care.

The Obstetric Care Consensus for the American College of Obstetricians and Gynecologist, February 2016, indicated that, in an effort to improve maternal and neonatal care, there are three levels of complexity, and they recommended referral of all high-risk patients to higher-level centers with the appropriate resources and personnel needed to address their increased complexity of care.

The EDM (undefined) Patient Record, dated at 11:14 P.M. on 2/12/18, indicated Patient #2 presented to the Emergency Department pregnant and in labor. The EDM Patient Record indicated Patient #2's blood pressure as 154/113 (very high blood pressure; with a narrow pulse pressure, the heart's failure to fill and failure to pump sufficient blood and oxygen to the all body organs; without sufficient blood flow, all major body functions are stressed).

Physician Note, dated at 3:15 P.M. on 2/12/18, indicated Patient #2's blood pressures remained elevated, Patient #2 required Labetalol (blood pressure medication), a diagnosis of pre-eclampsia and the start of Magnesium Sulfate (medication) for seizure prophylaxis. The Physician Note indicated no documentation to transfer her to higher-level center with the appropriate resources and personnel needed to address her increased complexity of care consistent with Hospital policy and Obstetric Standard of Care.

The CT (Computerized Tomography) Chest Angiography Report, dated at 4:40 P.M. on 2/12/18, indicated cardiomegaly (a large heart possibly caused by hypertension that has a high potential to be life-threatening).

Physician Notes indicated no documentation to transfer her to a higher-level center in response to her declining condition and her increased complexity of care.

The Rapid Response Team Note dated at 1:00 A.M. on 2/13/18, indicated Patient #2 had a sudden drop in her oxygen saturation level to 70% (greater than 90% is normal) and stated that her chest hurt and was having a hard time breathing and that she was not mentating (thinking) as normal.

The Nurse's Note, dated 2/13/18, indicated Patient #2 as transferred to the Telemetry Unit (Intermediate Care Unit) at 1:30 A.M. on 2/13/18.

Physician Notes indicated no documentation to transfer her to a higher-level center in response to her declining condition and her increased complexity of care.

The History & Physical (H & P), dated at 6:48 A.M. on 2/13/18, indicated Patient #2 as admitted to the Hospital's Intermediate Intensive Care Unit. The H & P indicated a Physician evaluation that Patient #2's echocardiogram revealed that although her CT (Computerized Tomography, imaging test) scan was negative for a pulmonary embolism (lung blood clot that can be life-threatening), Patient #2 had cardiomegaly (abnormal large heart).

The Nurses Note indicated Patient #2 as transferred to the Intermediate Care Unit for increased monitoring.

Physician Notes indicated no documentation to transfer her to higher-level center in response to her declining condition and her increased complexity of care consistent with Hospital policy and Obstetric Standard of Care.

The Rapid Response Team Note, dated at 5:04 P.M. on 2/13/18, indicated at 10:25 A.M. on 2/13/18, Patient #2 as stating that she could not breathe while the echocardiogram (heart ultrasound) technician was attempting to perform an echocardiogram. The Rapid Response Note indicated Patient #2 as transferred to the Intensive Care Unit (ICU).

Physician Notes indicated no documentation to transfer her to a higher-level center.

The Physician Progress Note, dated at 11:28 A.M. on 2/13/18, indicated Patient #2 as transferred to the Intensive Care Unit for worsening dyspnea (difficult breathing) and further management. The Physician Progress Note indicated she became acutely short of breath requiring the response of a Rapid (emergency) Response Team for decreasing oxygen saturation to the 50's (life-threatening low oxygen level) during an echocardiogram this morning. The Physician Progress Note indicated Patient #2 with diagnoses of Congestive Heart Failure, Post-Partum Cardiomyopathy (heart failure), Pulmonary Edema (fluid in the lungs) and Pre-Eclampsia (toxemia of pregnancy) in the post-partum period and that her condition was critical.

The Physician Progress Note indicated no documentation of Physician evaluation to transfer Patient #2 to a higher-level of care center.

The Cardiology Consultation Note, dated at 2:05 P.M. on 2/13/18, indicated a Cardiologist (heart specialist) recommended transfer of Patient #2 to a higher-level center given her severe cardiomyopathy to give her the option of advanced mechanical circulatory support (life-saving machine to support her failing heart) if needed (approximately 22 hours after the CT Scan indicated cardiomegaly on 2/12/18 at 4:30 P.M.).

The Discharge Summary, dated at 3:44 P.M. on 2/13/18, indicated Patient #2 as transferred to a higher-level of care center with the diagnosis of severe cardiomyopathy to their cardiomyopathy service.

The Face Sheet (undated) indicated Patient #2 as discharged at 10:18 P.M. on 2/13/18.

The Governing Body failed to ensure the Chief Executive Officer (President) was responsible for managing the entire Hospital.

Findings included:

The CEO failed to ensure Hospital Medical Staff Bylaws clearly described the organization structure of allied health professionals' acceptable standards for Obstetric patient care.

The Surveyor interviewed Corporate Quality Staff #1 at 11:20 A.M. on 4/4/18. Corporate Quality Staff #1 said that the Hospital delivers high-risk obstetric patients.

The Surveyor interviewed the Obstetric Medical Director at 3:30 P.M. on 4/4/18. The Obstetric Medical Director said Patient #1's care was not Peer-Reviewed.

The document titled Delineation of Certified Nurse Midwife (CNM) Privileges Desired, dated 3/2008, indicated CNM privileges included admission and examination of patients with documentation of a History & Physical Examination, management of normal labor, normal delivery of infants with a gestational age of 36 weeks and beyond, normal postpartum care. The Delineation of Certified Nurse Midwife Privileges indicated these patients should have no medical, surgical or obstetric complications.

The CEO failed to ensure that contracted services performed for the Quality Department were safe and effective.

The Surveyor interviewed the Hospital President at 1:45 P.M. on 4/12/18. The Hospital President said that Corporate Quality Staff #1 conducted the Hospital Internal Investigation regarding Patient #1. The President said Corporate Quality Staff #1 worked for the Corporation and worked for the Hospital under contract.

The document titled Support Services Agreement, dated 1/2018, indicated a contracted agreement between the Hospital and the Corporation for certain support services. The Support Services Agreement indicated that the Support Services were provided in a safe, timely, effective, and efficient manner.

The Hospital provided no documentation to indicate a mechanism to evaluate Corporate Quality Manager and Corporate Quality Staff #1's contracted services were performed and provided in a safe and effective manner.

Refer to TAG: 0084 (Contracted Services)

Based on records reviewed and interviews the Governing Body failed for 3 of 14 sampled patients (Patient #1, #2 & #5) to ensure that contracted services performed for the Quality Department were safe and effective and subjected to the same hospital-wide Quality Assessment and Performance Improvement (QAPI) evaluation as other services provided directly by the Hospital.

Findings included:

The Surveyor interviewed Corporate Quality Staff #1 at 11:20 A.M. on 4/4/18. Corporate Quality Staff #1 said the Corporation was her employer and the Corporation assigned her to assist the Hospital for the Hospital Internal Investigation regarding Patient #1. Corporate Quality Staff #1 said she conducted the Hospital Internal Investigation regarding Patient #1 on 12/20/17 (one week after Patient #1's death). She said that the Hospital was not her employer and she did not function under a contract or an agreement with the Hospital.

The Surveyor interviewed the Hospital President at 1:45 P.M. on 4/12/18. The Hospital President said that Corporate Quality Staff #1 conducted the Hospital Internal Investigation regarding Patient #1. The President said Corporate Quality Staff #1 worked for the Corporation and worked for the Hospital under contract.

The document titled Support Services Agreement, dated 1/2018, indicated a contracted agreement between the Hospital and the Corporation for certain support services. The Support Services Agreement indicated the Corporation participated in the Hospital's Quality Improvement Program at the Hospitals' request. The Support Services Agreement indicated that the Support Services were provided in a safe, timely, effective, and efficient manner. The Support Services Agreement indicated that the Corporation and the Hospital agreed to establish mutually agreed upon performance expectations and performance measures.

The Hospital provided no documentation to indicate a mechanism to evaluate Corporate Quality Manager and Corporate Quality Staff #1's contracted services were performed and provided in a safe and effective manner.

The Quality Assessment and Performance Improvement (QAPI) Program Condition of Participation was found out of compliance

Findings included:

The Hospital failed for 3 of 14 sampled patients (Patients #1, #2, & #5) to ensure that QAPI activities thoroughly analyzed adverse patient events, implemented preventative actions by the time of the Survey, and included learning and re-education of relevant staff throughout the Hospital.

Refer to TAG: A-0286

The Hospital Governing Body failed for 3 of 14 patients (Patients #1, #2, & #5) to ensure their responsibility for thorough and effective Quality Improvement Performance Improvement activities.

Refer to TAG: A-0309

The Hospital failed for 4 of 14 sampled patients (Patients #1, #2, #6 & #7) to ensure that Quality Assessment Performance Improvement (QAPI) activities thoroughly analyzed adverse patient events, implemented preventative actions by the time of the Survey, and included learning and re-education of relevant staff throughout the Hospital.

Findings included:

The Surveyor interviewed the Hospital Quality Manager at 9:30 A.M. on 4/4/18. The Hospital Quality Manager said Corporate Quality Staff #1 conducted the Hospital Internal Investigation because she (the Hospital Quality Manager) was not available. The Hospital Quality Manager said the Hospital conducted their weekly leadership meeting (Hospital Management) on 2/22/18 and discussed Patient #1. The Hospital Quality Manager said Hospital Management requested a Hospital Internal Investigation and referred for peer review (physician-to-physician patient care evaluation). The Hospital Quality Manager said the Hospital Medical Staff accepted Patient #1's case for peer review, however Patient #1's care had not yet been Peer-Reviewed because the Hospital was awaiting autopsy results. The Hospital Quality Manager said the Obstetric Nurse Director reviewed Patient #1's nursing care and concluded that there were no issues with nursing care.

The Surveyor interviewed Corporate Quality Staff #1 at 11:20 A.M. on 4/4/18. Corporate Quality Staff #1 said the Corporation assigned her to assist the Hospital with the Hospital Internal Investigation regarding Patient #1. Corporate Quality Staff #1 said she was aware of Patient #1's event of 2/12/18, on 2/13/18 and the Hospital conducted their Internal Investigation regarding Patient #1's care on 2/20/18. Corporate Quality Staff #1 said the Hospital Internal Investigation identified that there were no gaps in the care of Patient #1 and that care was appropriate.

Hospital QAPI activities failed to ensure that the Medical Staff conducted a Peer-Review to evaluate the quality of care provided to Patient #1.

The Medical Staff Bylaws, dated 6/18/12, indicated Peer-Review included evaluation or improvement of quality of health care activities as rendered by providers of heath care services to determine if health care services were performed in compliance with applicable Standards of Care.

The Surveyor interviewed the Obstetric Medical Director at 3:30 P.M. on 4/4/18. The Obstetric Medical Director said Patient #1's care was not Peer-Reviewed (evaluation of a physician's medical management by other physicians working in the same field, obstetrics and medicine). The Obstetric Medical Director said that there were no glaring medical findings.

The Surveyor interviewed the Chief Medical Officer (high-ranking Hospital physician administrator) at 1:30 P.M. on 4/4/18. The Chief Medical Officer said that the Hospital Internal Investigation was complete. The Chief Medical Officer said that the Medical Staff had not conducted a Peer-Review of Patient #1's care (by the time of the Survey). The Chief Medical Officer said that there were no glaring opportunities for improvement.

The Hospital provided no documentation to indicate the Medical Staff performed a Peer-Review for Patient #1 or consistent with Medical Staff Bylaws to evaluate or improve the quality of health care activities as rendered by providers of heath care services to determine if health care services were performed in compliance with applicable Standards of Care.

Hospital QAPI activities failed to conduct a thorough Hospital Internal Investigation after Patient #1's death.

The Hospital policy titled Obstetric Hemorrhage, dated 12/12/17, indicated Obstetric Staff weighed all bloodstained items and deduced the weight of the dry items to calculate an actual (quantified) blood loss (QBL) instead of an estimated blood loss (EBL).

The Surveyor interviewed Corporate Quality Staff #1 at 11:20 A.M. on 4/4/18. Corporate Quality Staff #1 said the Hospital Internal Investigation findings included, although the Hospital required actual (not estimated) measurement of blood loss as a new initiative that started 1/2018, Nursing Staff did not document Patient #1's actual measured blood loss according to Hospital Policy.

Three (3) of 14 sampled patients (Patients #1, #6 and #7) Nursing Staff did not document accurate blood loss.

The Hospital provided no documentation to indicate accelerated QAPI efforts (re-education and monitoring for compliance) by the time of the Survey.

Hospital QAPI activities failed to identify that neither the Nurses nor the Physicians documented whether antinausea medications were effective.

The Nurse's Note, dated 2/13/18 at 6:25 P.M., indicated Patient #1 was nauseated and vomiting since the procedure (unclear which procedure, the Cesarean section at 3:52 P.M. or the Bakri balloon placement at 5:35 P.M.) and complaining of midline chest pain and burning feelings (a 1-1/2 difference). The Nurse's Note indicated the Physician was present at the bed side, intramuscular Phenergan (nausea medication) ordered, and intravenous Pepcid (medication for indigestion) were given.

The Surveyors interviewed Hospital Quality Assurance #1 at 12:20 P.M. on 4/18/18. Hospital Quality Assurance said that, for the 3 anti-nausea and vomiting medications administered to Patient #1, neither the Nurses nor the Physicians documented whether these medications were effective.

The Hospital provided no documentation to indicate that the Hospital Internal Investigation identified that neither the Nurses nor the Physicians documented whether these medications were effective.

The Hospital QAPI activities failed to identify that an ultrasound was not performed to verify correct placement of the Bakri balloon.

The Hospital policy titled Obstetric Hemorrhage, dated 12/12/17, indicated proper placement of a Bakri balloon was confirmed by ultrasound.

Nurses Notes and Physician Notes, dated 2/13/18, indicated no documentation that an ultrasound was performed to verify correct placement of the Bakri balloon.

The Surveyor interviewed the Obstetric Nurse Educator, at 4:30 P.M. on 4/18/18. The Obstetric Nurse Educator said that an ultrasound was necessary to verify correct placement of the Bakri balloon (mechanical device inserted into the uterus).

The Surveyor interviewed the Obstetric Medical Director, at 7:58 A.M. on 4/25/18. The Obstetric Medical Director said that an ultrasound was not preformed to verify correct placement of the Bakri balloon.

The Hospital provided no documentation to indicate that the Hospital Internal Investigation identified that an ultrasound was not performed according to Hospital policy.

The Surveyor interviewed Hospital Quality Assurance Staff #1 at 1:15 P.M. on 4/18/18. Hospital Quality Assurance Staff #1 said the Obstetric Nurse Director closed (as completed) the Event Report regarding Patient #1 on 2/23/18.

The Medical Staff failed to conduct a complete and thorough Peer-Review to evaluate the quality of care provided to Patient #2.

The Surveyor interviewed Physician #1 at 11:32 on 4/18/18 and Patient #2's Attending Obstetric Physician. Physician #1 said she believed Patient #2's medical care was referred for Peer-Review and that the Department of Medicine sent her a piece of paper that requested her impression of the care provided to Patient #2. Physician #1 said the Department of Medicine asked her no specific questions and she assumed that the Obstetric Department was to review Patient #2's Obstetric Care.

The document titled Peer-Review List, dated 1/1/8 though 4/4/18, indicated no documentation that Patient #2's care was referred for review.

Based on records reviewed and interviews the Governing Body failed for 3 of 14 patients (Patients #1, #2, & #5) to ensure their responsibility for thorough and effective Quality Improvement Performance Improvement (QAPI) activities after Patient #1's death following childbirth for improved quality of care and patient safety. QAPI activities failed to discover concerns regarding Patient #1's Medical Management and Nursing Care. QAPI activities failed to implement timely and appropriate Peer-Review for Patients #2 & #5.

Findings included:

The Governing Body failed to ensure that the Medical Staff failed to conduct a Peer-Review to evaluate the quality of care provided to Patient #1.

The Medical Staff Bylaws, dated 6/18/12, indicated Peer-Review included evaluation or improvement of quality of health care activities as rendered by providers of heath care services to determine if health care services were performed in compliance.

The Surveyor interviewed the Obstetric Medical Director at 3:30 P.M. on 4/4/18. The Obstetric Medical Director said Patient #1's care was not Peer-Reviewed (evaluation of a physician's medical management by other physicians working in the same field, obstetrics and medicine).

The Surveyor interviewed the Chief Medical Officer (high-ranking Hospital physician administrator) at 1:30 P.M. on 4/4/18. The Chief Medical Officer said that the Medical Staff had not conducted a Peer-Review of Patient #1's care (by the time of the Survey). The Chief Medical Officer said that there were no glaring opportunities for improvement.

The Hospital provided no documentation to indicate the Medical Staff performed a Peer-Review for Patient #1 or consistent with Medical Staff Bylaws to evaluate or improve the quality of health care activities as rendered by providers of heath care services to determine if health care services were performed in compliance with applicable Standards of Care.

The following regarding QAPI activities failure to implement timely and appropriate Peer-Review for Patients #2 & #5.

The Surveyor interviewed Physician #1 at 11:32 on 4/18/18 and Patient #2's Attending Obstetric Physician. Physician #1 said she believed Patient #2's medical care was referred for Peer-Review and that the Department of Medicine sent her a piece paper that requested her impression of the case. Physician #1 said the Department of Medicine asked her no specific questions and she assumed that the Obstetric Department was to review Patient #2's Obstetric Care.

The document titled Peer-Review List, dated 1/1/8 though 4/4/18, indicated no documentation that Patient #2's care was referred for review.

The Discharge Summary, dated at 8:27 on 3/11/18, indicated Patient #5 presented to the Emergency Department with high blood pressures, shortness of breath and chest pain after discharge on 3/4/18 following delivery of her newborn and admitted to the Obstetric Unit for management of preeclampsia and hypertension.

The document titled Peer-Review List, dated 1/1/8 though 4/4/18, indicated Patient #5's care was referred for Obstetric review (approximately 3 weeks after Patient #5's readmission).

The Medical Staff Condition of Participation was found out of compliance.

Findings included:

The Medical Staff failed for 3 of 14 sampled patients (Patients #1, #2 & 5) to be accountable to the Hospital Governing Body for the oversite for the quality of care provided by Obstetric, Anesthesia and Certified Nurse Midwifery providers.

Refer to TAG: A-347

The Medical Staff failed for 3 of 14 sampled patients (Patients #1, #2 & #5) to have an organized Medical Staff for allied health professionals that functioned within the delineation of privileges granted by the Medical Staff Bylaws.

Refer to TAG: A-356

The Medical Staff failed for 1of 8 Obstetric sampled patients (Patient #8) in a total of 14 sampled patients, the Hospital failed to ensure there was documentation of a medical history and physical examination.

Refer to TAG: A: 0358

Based on records reviewed and interviews the Medical Staff failed for 3 of 14 sampled patients (Patients #1, #2 & # 5) to be accountable to the Hospital Governing Body for the oversite for the quality of care provided by Obstetric, Anesthesia and Certified Nurse Midwifery (CNM) providers.

Findings included:

1.) The Medical Staff failed to immediately and comprehensively respond to changes in Patient #1's condition to determine whether the symptoms such as calf pain represented a possible emergent, life threatening condition. The Medical Staff failed to accurately and consistently record the results of medical evaluations.

The History & Physical, dated at 9:19 A.M. on 2/12/18, and Discharge Summary, dated at 6:27 P.M. on 2/26/18 (dictated 13 days after Patient #1's death on 2/13/18), indicated Patient #1 was admitted on 2/12/18 for induction of labor at 39 weeks pregnant (full-term). Diagnoses included: Gestational Diabetes Mellitus treated with insulin, gestational hypertension, obesity, severe pre-eclampsia (a condition in pregnancy characterized by high blood pressure, sometimes fluid retention and protein in the urine), elevated cholesterol and triglycerides (blood work indicating possible heart problems) and tobacco disorder with daily usage.

Nurse's Note dated 7:35 A.M. on 2/12/18, indicated Patient #1 had complained of calf pain.

The Surveyors interviewed Registered Nurse (RN) #1, at 8:20 A.M. on 4/18/18. RN #1 said she cared for Patient #1 at the time of admission on 2/12/18 during the 7:00 A.M. to 7:00 P.M. shift. RN #1 reviewed Patient #1's chart and said Patient #1 had a significant cardiovascular history and a family history of hypertension, a myocardial infarction and a cerebrovascular accident (which can be thrombotic events caused by blood clots). RN #1 said Patient #1 had a new complaint of left crampy calf pain and there was no assessment of the color, size or temperature of the calf documented.

Nurse's Note dated 7:35 A.M. on 2/12/18, indicated Patient #1 had complained of calf pain.

Nurse's Note dated 7:42 A.M. on 2/12/18, indicated Physician #3 examined Patient #1 for a "calf cramp". Nurse's Note indicated the Physician gave no new orders. Nurse's Note indicated the Physician gave no order for a Doppler ultrasound (test to evaluate for a blood clot in the leg) was needed.

Physician Notes indicated no documentation of a physicial examination of Patient #1's leg pain by Physician #3 (as documented in the Nurse's Note dated 7:42 A.M. on 2/12/18).

Physician Note dated 11:07 A.M. on 2/12/18 and documented by Physician #1, indicated Patient #1 denied calf tenderness.

The Surveyor interviewed Physician #1 at 11:32 A.M. on 4/18/18. Physician #1 said that leg swelling was not unusual with a Patient who had pre-eclampsia. Physician #1 said that leg pain was unusual. Physician #1 said she did not know if Patient #1 had unilateral swelling in one leg and said that it was not documented in Patient #1's medical record. Physician #1 said there was no documentation in the medical record regarding Physician #3's evaluation of Patient #1's left leg when Patient #1 complained of left leg pain.

Physician Notes indicated no documentation of a physical examination by Physician #1 of Patient #1's leg pain. The Physician Notes indicated no documentation of further diagnostic evaluation of Patient #1's left leg pain even though pregnancy was a risk factor for a blood clot.

The Admission History and Physical (H&P) as documented by a CNM at 9:19 A.M. on 2/12/18, indicated Patient #1's history of present illness, Patient #1 reported left calf pain that was intermittent and had been going on for a few days with bilateral leg edema within normal limits, no cord was felt (a possible sign of a blood clot). The H&P Plan of Care did not indicate further diagnostic evaluation of Patient #1's left leg pain, even though pregnancy was a risk factor for a blood clot.

Physician Notes and Orders indicated no documentation to indicate that a Doppler ultrasound was ordered or completed to determine a Deep Vein Thrombosis (DVT, clot in the leg).

The Medical Staff failed to immediately and comprehensively respond to Patient #1's condition to determine whether the acute symptoms of chest pain, shortness of breath, nausea and vomiting, represented a possible emergent, life threatening condition such as a heart attack. The Medical Staff failed to accurately and consistently record the results of medical evaluations. The Medical Staff failed to accurately assess and classify Patient #1's ASA (American Society of Anesthesiologist) score - (a physical status classification of preoperative patients for an anesthetic risk assessment, based on 5 classes).

The Surveyor interviewed RN #2 at 10:45 A.M. on 4/18/18. RN #2 said Patient #1 was obese and a heavy smoker (smoking is a risk factor for heart disease).

Nurse's Note dated at 7:35 A.M. on 2/12/18, indicated Patient #1 had increased blood pressure readings of 162/102 (normal 120/80, and a heart rate of 105 (normal 60-100) beats per minute (bpm).

Nurse's Note dated 2/12/18 at 7:48 A.M., indicated a blood pressure 167/96, at 7:49 A.M., heart rate of 107 beats per minute. Nurse's Note dated 2/12/18 at 9:06 A.M., indicated the CNM was aware of high blood pressure 168/96 with heart rate of 93 bpm and will notify Physician #1. Nurse's Note dated 2/12/18 at 9:50 A.M., indicated Labetalol (a medication to lower blood pressure and heart rate) was given intravenously. The Nurse's Note indicated no documentation of who (the nurse or the CNM) notified Physician #1.

Nurses Note, dated 2/12/18 at 10:42 A.M., indicated Patient #1 complained of difficulty breathing. Physician #1 was in the room, Patient #1 was sitting upright in bed at a 90-degree angle (to assist with breathing) and given oxygen via a face mask at 10 liters, oxygen saturation was 98% (the percentage of oxygen in the blood stream (normal greater than 90%). The Nurses Note indicated Patient #1 started to feel better.

The CNM Note, dated at 9:19 A.M. on 2/12/18 indicated Patient #1 as hypertensive (high blood pressure) with blood pressures of 163/67, 152/96, 167/96, 168/96 with a high heartbeat of 104 beats per minute (tachycardia, normal 60-100 beats per minute).

Physician Note, at 11:07 A.M. on 2/12/18, indicated on admission Patient #1 had elevated blood pressures in the 160's/90's range, treated with Labetalol (a medication to lower blood pressure) intravenously. Laboratory blood work indicated elevated protein: creatinine ratio, indicative of a diagnosis of pre-eclampsia. Magnesium Sulfate (medication) was started to reduce the risk of seizures. After a loading dose of Magnesium Sulfate 6 milligrams, Patient #1 had chest pressure. The Physician Note indicated no further cardiac evaluation was performed to determine whether an acute cardiac event (heart attack) was occurring and there was no documentation of evaluation for transfer to a higher-level center with the appropriate resources and personnel needed to address Patient #1's increased complexity of care.

The Surveyor interviewed Physician #1 at 11:32 A.M. on 4/18/18. Physician #1 said Patient #1's shortness of breath was due to the Magnesium and that chest discomfort was not normal.

The Physician Note indicated no documentation of further cardiac diagnostic evaluation, or an electrocardiogram to evaluate Patient #1's chest discomfort to determine a heart problem until approximately 34 hours later. The Physician Note indicated no documentation of cardiac enzymes (a blood test to indicate a heart attack).

The Surveyor interviewed the Clinical Pharmacist at 1:00 P.M. on 4/25/18. The Clinical Pharmacist said Patient #1's shortness of breath and chest pressure was not a side effect of Magnesium. The Clinical Pharmacist said Magnesium side effects would have occurred immediately with the start of Magnesium. The Clinical Pharmacist said the start of the Magnesium was at 10:12 A.M. on 2/12/18 and Patient #1 complained of chest pain at 10:42 A.M. on 2/12/18 (30 minutes later).

The CNM Note, dated at 1:13 P.M. on 2/12/18, indicated Patient #1's shortness of breath had improved. The CNM note indicated no documentation that Patient #1's shortness of breath was resolved.

RN #1 said Patient #1 was treated with insulin for diabetes, she had a significant cardiovascular history and a family history of hypertension, a heart attack (heart disease is more likely in patients with diabetes and a family history of heart disease), and a cerebrovascular accident (which can be thrombotic events caused by blood clots).

RN #1 said when Patient #1 had breathing problems; Patient #1 said, "I am having a hard time and difficulty breathing", twice. The Surveyor observed RN #1 demonstrate how Patient #1 held her right hand over her chest (with the her shortness of breath). RN #1 said Patient #1 was sitting bolt upright and required 10 liters of oxygen, which is not normal. RN #1 said that Patient #1 was a high-risk patient and said that we usually do not take care of patients as complex as Patient #1.

The Nurse's Note, dated 2/13/18 at 6:25 P.M., indicated Patient #1 was nauseated and vomiting since the procedure (unclear which procedure, the Cesarean section at 3:52 P.M. or the Bakri balloon (a medical device used to temporarily control postpartum hemorrhage) placement at 5:35 P.M. and complaining of midline chest pain and burning feelings. The Physician was present at the bed side, intramuscular Phenergan (nausea medication) ordered, and intravenous Pepcid (medication for indigestion) were given.

The Medication Administration Record, dated 2/13/18, indicated the following anti-nausea and vomiting medications were ordered without a documented response (relief or continuation of the midline chest pain and burning feelings symptoms and the action taken, and Physician notification):

-Phenergan (medication for nausea) administered at 6:27 P.M.,

-Pepcid (medication for indigestion) administered at 6:45 P.M., and

-Calcium Carbonate (Tums) at 2/13/18 at 7:35 P.M. ordered at 7:35 P.M. but not documented as administered.

A portable Chest X-Ray was ordered at 2/13/18 at 7:01 P.M. for Patient #1's chest pain, findings were no active process in the chest.

Physician Notes and Doctors Orders, dated 2/12/18 to 2/13/18, indicated no documentation of diagnostic tests, other than a chest x-ray obtained at 7:01 P.M. on 2/13/18, to exclude medical diseases related to Patient #1's complaints of shortness of breath and chest pain on 2/12/18 and 2/13/18.

Physician Notes and Doctors orders indicated no documentation or order for an Electro-Cardiogram (ECG) despite Patient #1's complaint of chest pain.

Nurses Note, dated 2/13/18 at 7:55 P.M., indicated Patient #1's Family Member called a Registered Nurse to examine Patient #1 because Patient #1 felt cold (likely an sign of hemorrhage accoding to Hospital policy) and she was desaturating in the 70's (oxygen saturation indicated inadequate oxygenation, normal greater than 90%). Patient #1 received supplemental oxygen with a non-rebreather mask (an oxygen delivery device to deliver a higher concentration of oxygen than an oxygen face mask for patients with a severe and deteriorating ability to breathe). The Nurses Note indicated Patient #1 received 10 liters of oxygen and her oxygen saturations were unstable and ranging from 70% to 90% (significantly insufficient oxygen in her blood), with tachycardia (fast heart rate, normal less than 100) in the 130's, blood pressure 80/60 (very low) and a Rapid Response Team was called as Patient #1's condition continued to decline.

The Emergency Response Team (ERT) Sheet, dated 2/13/18, indicated an emergency response team was called at 8:13 P.M. and heart rhythm evaluation was performed using a cardiac monitor (1-1/2 hours after Patient #1's complain of chest pain at 6:35 P.M. on 2/13/18). Patient #1 had seizure activity at 8:27 P.M., a respiratory arrest at 8:28 P.M., and a cardiopulmonary arrest at 8:30 P.M. and the cardiac rhythm was ventricular tachycardia (an ineffective and life-threatening heartbeat), at 8:38 P.M. ventricular fibrillation (a heartbeat more serious than ventricular tachycardia) and she progressed to asystole (death).

Physician Note, dated at 6:27 P.M. on 2/26/18, indicated Patient #1 received the medication Alteplase (TPA, a medication to breakdown clots for a myocardial infarction (heart attack) during the cardiopulmonary arrest for suspected massive lung clot.

An Electrocardiogram (EKG), dated at 8:21 P.M. and 8:22 on 2/13/18 and during Patient #1's cardiopulmonary arrest, indicated Patient #1 had an acute myocardial infarction (heart attack).

The Surveyor interviewed Cardiologist #1 at 4:40 P.M. on 4/25/18. Cardiologist #1 said Patient #1's EKG's indicated she had an acute myocardial infarction (heart attack).

The document titled Death Report dated 2/13/18, indicated Patient #1's time of death as 9:12 P.M. on 2/13/18.

The Medical Staff failed to accurately assess and classify Patient #1's ASA (American Society of Anesthesiologist) score to evaluate Patient #1's physical status to identify anesthesia risk prior to her Cesarean section and prior to administration of medications for low blood pressure.

The Record of the Operation, dated 2/13/18, indicated Patient #1's preoperative diagnosis was a Cesarean section due to failure to progress in labor.

The History & Physical, dated at 9:19 A.M. on 2/12/18, indicated Patient #1 had hypertension prior to admission (and anti-partum hypertension and tachycardia) with pre-eclampsia, and significant family history of cardiovascular disease and diabetes treated with insulin in the community.

The Pre-Anesthesia Note, dated at 9:15 A.M. on 2/13/18, indicated the Anesthesiologist documented Patient #1 did not have a cardiac (heart disease) history and endocrine (diabetes) history.

The Pre-Anesthesia Note, indicated Patient #1 as assigned an ASA Score of 2 (mild systemic disease) even though the History & Physical, dated at 9:19 A.M. on 2/12/18, and Discharge Summary, dated at 6:27 P.M. on 2/26/18 indicated Patient #1 had a history of Gestational Diabetes Mellitus treated with insulin, gestational hypertension, obesity, severe pre-eclampsia (a condition in pregnancy characterized by high blood pressure, sometimes fluid retention and protein in the urine), elevated cholesterol and triglycerides (blood work indicating possible heart problems) and tobacco disorder with daily usage.

The Pre-Anesthesia Note, indicated Patient #1 as assigned an ASA Score of 2 (mild systemic disease) even though the Nurse's Note dated 7:35 A.M. on 2/12/18, indicated Patient #1 had complained of calf pain.

The Pre-Anesthesia Note, indicated Patient #1 as assigned an ASA Score of 2 (mild systemic disease) even though the Physician Note, at 11:07 A.M. on 2/12/18, indicated Patient #1 had chest pressure.

The Anesthesia Record, at 3:52 P.M. to 4:36 P.M. on 2/13/18, indicated the Anesthesiologist administered Ephedrine and Phenylephrine (medications for anesthesia induced low blood pressure) for Patient #1's low blood pressures.

Lexicom (a medication reference), dated 2018, indicated Ephedrine (medication) should not be ordinarily used for patients with heart pain or hypertension.

Lexicom, dated 2018, indicated Phenylephrine (medication), may cause decreased blood flow to vital organs (heart, lungs and kidneys) even though the Physician Note, at 11:07 A.M. on 2/12/18, indicated Patient #1 had chest pressure.

The Medical Staff failed to immediately and comprehensively respond to Patient #1's condition to determine whether the symptoms represented a possible emergent, life threatening condition such as post-partum hemorrhage and hypovolemia (decreased blood volume) in the setting of a high-risk obstetric patient. The Medical Staff failed to accurately and consistently record the results of medical evaluations.

Physicians Notes, dated 2/12/18 to 2/13/18, indicated no documentation to vary intravenous fluid rates based on Patient #1's condition consistent with Hospital policy.

The Hospital Policy, titled Obstetric Hemorrhage, dated 12/12/17, indicated that the policy was to identify early recognition of excessive blood loss in the peripartum (preceding or following childbirth) period. Some of the predisposing factors to obstetric hemorrhage were prolonged labor, an operative delivery and drugs, including but not limited to general anesthesia, oxytocin (medication) and Magnesium Sulfate (medication). Weigh all blood stained items and deduct the weight of the dry items to calculate blood loss, 1 Gram is equivalent to 1 milliter (ml) of blood. The policy indicated symptoms of an obstetric hemorrhage was hypovolemia, cold clammy skin, profound hypotension (blood pressure below 90/60), fear, anxiety and restlessness.

The Obstetrical Operative Note, dated at 5:24 P.M. on 2/13/18, indicated a primary Cesarean section was performed with an estimated blood loss of 1,000 milliters (ml), with no complications, but Patient #1's post-operative condition was documented as being serious.

The Anesthesia Record, dated at 3:25 P.M. on 2/13/18 indicated Patient #1 received 1500 milliters of intravenous fluids and had an estimated blood loss of 1,000 milliters (inconsistent with Hospital policy).

The Hospital Policy, titled Obstetric Hemorrhage, dated 12/12/17, indicated that the policy was to identify early recognition of excessive blood loss in the peripartum (preceding or following childbirth) period. Some of the predisposing factors to obstetric hemorrhage were prolonged labor, an operative delivery and drugs, including but not limited to general anesthesia, oxytocin (medication) and Magnesium Sulfate (medication). Weigh all blood-stained items and deduct the weight of the dry items to calculate blood loss, 1 Gram is equivalent to 1 milliter (ml) of blood. The policy indicated symptoms of an obstetric hemorrhage was hypovolemia, cold clammy skin, profound hypotension (blood pressure below 90/60), fear, anxiety and restlessness.

The Anesthesia Record, dated 2/13/18, indicated at 3:25 P.M. Patient #1 entered the Operating Room, Patient #1's blood pressure was 180/86 (very high blood pressure) with a heart rate of 110 beats per minute and (tachycardia). The Anesthesia Record indicated Patient #1's blood pressure decreased to 98/52 (low blood pressure) with a heart rate of 110 bpm and the Anesthesiologist administered 4 doses of Ephedrine and 4 doses of Phenylephrine. Both medications may be administered for anesthesia induced hypotension (low blood pressure).

The Anesthesia Record, indicated Patient #1 as transferred from the Operating Room to her room for recovery at 2/13/18 at 4:59 P.M.

The Nurse's Note, dated 2/13/18 at 5:00 P.M., indicated post Cesarean section blood clots were expressed from the uterus and various medications were to be administered. The Nurse's Note, dated 2/13/18 at 5:35 P.M., indicated Patient #1 Patient's bleeding had become heavy and Patient #1 said "I don't feel right", blood pressure 81/46 (low blood pressure). Physician called to the bedside, two clots were extracted manually by him and a Bakri (mechanical device inserted into the uterus to manage hemorrhage) balloon was placed. The Nurse's Note, dated at 6:00 P.M. on 2/13/18, indicated Patient #1's bleeding was stable after the Bakri balloon was in placed with a firm fundus (uterus) and her blood pressure was 120/49.

The Obstetrical Operative Note, indicated an estimated blood loss of 1,000 milliters (ml), and Nurses Notes, dated, 2/13/18 at 5:00 P.M. and 5:35 P.M. indicated vaginal bleeding (post-partum hemorrhage) without an estimated blood loss.

The Obstetric Hemorrhage Policy, dated 12/12/17, indicated Bakri balloon placement was to be confirmed by ultrasound.

Physician Notes indicated no documentation that an ultrasound confirmed placement of the Bakri balloon consistent with Hospital policy.

The Massive Blood Transfusion Protocol dated, 5/2016, indicated the massive blood transfusions were implemented for patients with acute and significant bleeding.

Physician's order, dated at 6:19 P.M. on 2/13/18, indicated an order for 2 units of packed red blood cells for Patient #1's active bleeding and hypotension and transfuse 2 units within one hour. There was no documentation to indicated the blood was administered until Patient #1's cardiopulmonary resuscitation.

The Surveyor interviewed RN #3 at 3:20 P.M. on 4/12/18. RN #3 said Patient #1 had a lot of vaginal bleeding after the Cesarean section and Patient #1's blood pressure dropped dramatically. RN #3 said Patient #1 received Carboprost Tromethamine and Misoprostol (medications to stop bleeding) and Physician #2 inserted a Bakri balloon into Patient #1's vagina. RN #3 said Patient #1 did not receive the ordered blood because Patient #1's hematocrit and hemoglobin (blood test and a late sign of acute blood loss) were normal. RN #3 said at approximately 7:30 P.M. Patient #1 was vomiting non-stop and Patient #1 complained of chest burning. RN #3 said she went back to Patient #1's room after approximately 15 minutes as Patient #1 reported shortness of breath, that she felt cold and Patient #1's oxygen levels and blood pressures had decreased. RN #3 said Physician #2 determined Patient #1 had an irregular heartbeat and Physician #2 requested the Obstetric staff call the Hospital Emergency Response Team.

The ERT Report, dated 2/13/18, indicated blood was administered during cardiopulmonary resuscitation and 32 minutes after Patient #1 was without a heartbeat.

The Physician Notes, dated 2/13/18, indicated no documentation of fluid or blood product resuscitation replacement for maternal hemorrhage prior to Patient #1's cardiopulmonary arrest.

The document titled Death Report dated 2/13/18, indicated Patient #1's time of death as 9:12 P.M. on 2/13/18.

An addendum to the Obstetrical Operative Note, dated at 11:06 P.M. on 2/13/18 and approximately 2 hours after Patient #1 died, indicated Patient #1's diagnosis was severe pre-eclampsia and diabetes mellitus affecting pregnancy.

The Surveyor interviewed the Obstetric Nurse Director at 2:08 P.M. on 4/4/18. The Obstetric Director said that Patient #1 had vaginal bleeding in the Operating Room and in the Postoperative Recovery Room. The Obstetric Nurse Director said that for Patient #1's case, it was identified that the Nurses needed to determine Patient #1's actual blood loss and not the estimated blood loss which was not accurate. The Obstetric Nurse Director said that the Obstetric team did not implement the Massive Blood Transfusion policy because Patient #1 was not bleeding enough.

The Medical Staff failed to immediately and comprehensively respond to Patient #1's condition to determine an appropriate to transfer consistent with Hospital policy and Obstetric Standard of Care. The Medical Staff failed to follow their transfer polices for high-risk obstetric patients. The Hospital did not have guidelines for determining which patients were high-risk.

The Obstetric Care Consensus for the American College of Obstetricians and Gynecologist, February 2016, indicates that, in an effort to improve maternal and neonatal care, there are three levels of complexity, and they recommended referral of all high-risk patients to higher-level centers with the appropriate resources and personnel needed to address their increased complexity of care. The Hospital provided the Maternal Transfer policy to indicate direction for maternal transfer.

The Hospital policy, titled Maternal Transfer, dated 6/2015, indicated the decision is made by the attending physician or CNM in consultation with a physician to transfer patients because of premature labor, premature rupture of membranes, early gestational age, severe toxemia, severe diabetes, or any High-Risk patient. There were no guidelines for determination of High -Risk patients.

The Admission History and Physical, dated at 9:19 A.M. on 2/12/18 indicated approximately 2-1/2 hours after Patient #1 presented to the Hospital, Patient #1 as hypertensive (high blood pressure) with blood pressures of 163/67, 152/96, 167/96, 168/96 with a high heartbeat of 104 beats per minute (tachycardia, normal 60-100 beats per minute).

The Admission History and Physical, dated at 9:19 A.M. on 2/12/18 indicated no documentation of evaluation for possible transfer to higher-level center with the appropriate resources and personnel needed to address Patient #1's increased complexity of care according to Hospital policy and Obstetric Standard of Care.

Physician Note, at 11:07 A.M. on dated 2/12/18, indicated Patient #1 had elevated blood pressures in the 160's/90's range, and was treated with Labetalol (a medication to lower blood pressure) intravenously. Laboratory blood work indicated elevated protein: creatinine ratio, which is indicative of a diagnosis of pre-eclampsia. Magnesium Sulfate (medication) was started to reduce the risk of seizures. After a loading dose of Magnesium Sulfate 6 milligrams, Patient #1 had chest pressure and shortness of breath.

The Physician Note indicated no further cardiac assessment was performed to determine an acute cardiac event (heart attack) and the Physician Note indicated no documentation of evaluation for transfer to a higher-level center with the appropriate resources and personnel needed to address her increased complexity of care.

Physician Notes indicated no documentation that a Physician evaluated Patient #1 for need to transfer to a perinatal care center hospital for high-risk pregnancies prior to scheduling Patient #1's Cesarean section on 2/13/18.

Patient #1's Physician Notes, dated 2/12/18 through 2/13/18, indicated no indication to transfer Patient #1 to a higher-level center with the appropriate resources and personnel needed to address her increased complexity of care in accordance with Hospital policy and Obstetric Standard of Care.

2.) The Hospital failed to ensure the Medical Staff appropriately arranged Patient #2's (an obstetric high-risk patient), transfer to a higher-level center in response to her declining condition and her increased complexity of care consistent with Hospital policy and Obstetric Standard of Care.

The Obstetric Care Consensus for the American College of Obstetricians and Gynecologist, February 2016, indicates that, in an effort to improve maternal and neonatal care, there are three levels of complexity, and they recommended referral of all high-risk patients to higher-level centers with the appropriate resources and personnel needed to address their increased complexity of care. The Hospital provided the Maternal Transfer policy to indicate direction for maternal transfer.

The Hospital policy, titled Maternal Transfer, dated 6/2015, indicated the decision is made by the attending physician or CNM in consultation with a physician to transfer patients because of premature labor, premature rupture of membranes, early gestational age, severe toxemia, severe diabetes, or any High-Risk patient. There were no guidelines for determination of High -Risk patients.

Patient #2's Emergency Department Record, dated at 11:14 P.M. on 2/12/18, indicated Patient #2 presented to the Emergency Department pregnant and in labor. The Record indicated Patient #2's blood pressure as 154/113. The Patient Record indicated weight as a Body Mass Index (BMI) of 32.4 (obese is greater than 30).

The Admission and Physical, dated at 4:07 P.M. on 2/12/18, indicated a CNM admitted Patient #2 to the Hospital in active labor on 2/12/18.

The Pre-Operative Anesthesia Evaluation, (undated and unsigned) indicated no documentation to indicate Patient #2 as hypertensive (high blood pressure). However the Record indicated Patient #2's blood pressure as 154/113 (hypertensive).

The Vaginal Delivery Report, dated 2/12/18, indicated Patient #2 delivered a live infant at 2:20 P.M. on 2/12/18.

Nurse's Notes, dated at 3:02 P.M. on 2/12/18, indicated Patient #2 as having oxygen saturation levels in the 80's (95-100 is normal).

Physician Note, dated at 3:15 P.M. on 2/12/18, indicated Patient #2's blood pressures remained elevated, Patient #2 required Labetalol (blood pressure medication), a diagnosis of pre-eclampsia and the start of Magnesium (medication) for seizure preventive prophylaxis.

The Physician Note indicated no documentation to transfer Patient #2 to higher-level center with the appropriate resources and personnel needed to address her increased complexity of care consistent with Hospital policy and Obstetric Standard of Care.

The CT (Computerized Tomography, imaging test) Chest Angiography Report, dated at 4:40 P.M. on 2/12/18, indicated cardiomegaly (a large heart possibly caused by hypertension and with a high potential to be life-threatening).

Physician Notes indicated no immediate evaluation of Patient #2 for possible transfer to higher-level center in response to her declining condition and her increased complexity of care.

Nurse's Note, dated at 5:13 P.M. on 2/12/18, indicated Patient #2's oxygen level decreased to 88% at 1:34 P.M.

The Rapid Response Team (RRT), Note dated at 1:00 A.M. on 2/13/18, indicated Patient #2 had a sudden drop in her oxygen saturation level to 70% (significantly low) and stated that her chest hurt and she was having a hard time breathing and that she was not mentating (thinking) as normal.

The RRT Note indicated the RRT responded at 1:00 A.M. because of Patient #2's unresolved chest pain.

The Nurse's Note, dated at 1:06 A.M. on 2/13/18, indicated Patient #2 as having acute chest pain, shortness of breath and oxygen saturation levels 70%-80% (very low) and the RRT as notified.

The Nurse's Note, dated 2/13/18, indicated Patient #2 as transferred to the Telemetry Unit (Intermediate Care Unit) at 1:30 A.M. on 2/13/18.

The Hospital policy titled Admission, Discharge to the Intermediate Care Unit, dated 6/2017, indicated criteria for patient admission included low probability of a heart attack and stable patients requiring advanced nursing care. The Admission, Discharge to the Intermediate Care Unit policy did not indicate criteria included post-partum patients with cardiomegaly, acute chest pain, shortness of breath and unstable oxygen saturation levels as an appropriate admission to the Intermediate Care Unit.

Physician Notes indicated no documentation to transfer Patient #2 to higher-level center in response to her declining condition and her increased complexity of care.

The History & Physical (H & P), dated at 6:48 A.M. on 2/13/18, indicated Patient #2 as admitted to the Hospital's Intermediate Intensive Care Unit. The H & P indicated a Physician evaluation that Patient #2's echocardiogram revealed that although her CT Scan was negative for a pulmonary embolism (lung blood clot that can be life-threatening), Patient #2 had cardiomegaly (abnormal large heart). The Nurses Note indicated Patient #2 as transferred to the Intermediate Care Unit for increased monitoring.

Physician Notes indicated no documentation to transfer Patient #2 to higher-level center in response to her declining condition and her increased complexity of care consistent with Hospital policy and Obstetric Standard of Care.

The Rapid Response Note, dated at 5:04 P.M. on 2/13/18, indicated at 10:25 A.M. on 2/13/18, Patient #2 as stating that she could not breathe while the echocardiogram (heart ultrasound) technician was attempting to perform an echocardiogram. The Rapid Response Note indicated Patient #2 had a heart rate of 130-140 (very fast) and a blood pressure of 155/120 and oxygen saturation levels dropped to 78 (very low). The Rapid Response Note indicated Patient #2 as transferred to the Intensive Care Unit (ICU).

The Physician Progress Note, dated at 11:28 A.M. on 2/13/18, indicated Patient #2 as transferred to the Intensive Care Unit for worsening dyspnea (difficult breathing) and further management. The Physician Note indicated Patient #2 became acutely short of breath requiring the response of a Rapid Response Team for decreasing oxygen saturation to the 50's (life-threatening low oxygen level, normal is 95-100) during an echocardiogram this morning.

The Physician Progress Note indicated Patient #2 had diagnoses of Congestive Heart Failure, Post-Partum Cardiomyopathy (heart failure), Pulmonary Edema (fluid in the lungs) and Pre-Eclampsia (toxemia of pregnancy) in the post-partum period and that her condition was critical.

The Physician Progress Note indicated no documentation of Physician evaluati

Based on records reviewed and interviews the Medical Staff failed for 3 of 14 sampled patients (Patients #1, #2 & #5) have an organized Medical Staff for allied health professionals that functioned within the delineation of priviliges granted by the Medical Staff Bylaws.

Findings included:

The Surveyor interviewed Corporate Quality Staff #1 at 11:20 A.M. on 4/4/18. Corporate Quality Staff #1 said that the Hospital delivers high-risk obstetric patients.

The Surveyor interviewed the Obstetric Medical Director at 3:30 P.M. on 4/4/18 and Physician #1 at 11:32 A.M. on 4/18/18. They said the Certified Nurse Midwives (CNM) managed the patient labor and the physicians managed patient medical issues. Physician #1 said that the physicians reported off to another physician and a CNM reported off to another CNM for change of shift report.

The document titled Delineation of Certified Nurse Midwife Privileges Desired, dated 3/2008, indicated CNM privileges included admission and examination of patients with documentation of a History & Physical Examination, management of normal labor, normal delivery of infants with a gestational age of 36 weeks and beyond, normal postpartum care. The Delineation of Certified Nurse Midwife Privileges indicated these patients should have no medical, surgical or obstetric complications.

Based on records reviewed and interview the Medical Staff failed for 1of 8 Obstetric sampled patients (Patient #8) in a total of 14 sampled patients to ensure documentation of a medical history and physical examination.

Findings included:

One (1) of 8 Obstetric sampled patients (Patient #8) in 10 sampled patients indicated no documentation of an admission History & Physical (H&P) examination.

The Pre-Operative Physician Note, dated at 9:10 A.M. on 3/22/18, Physician Progress Notes dated at 11:20 A.M. on 3/22/19 through 3/23/18 at 8:11 A.M. and Discharge Summary, dated at 8:37 A.M. on 3/24/18 indicated no documentation of an admission H&P examination for Patient #8.

The Surveyor interviewed the Obstetric Nurse Educator at 10:30 A.M. on 4/12/18 as a navigator for the electronic medical record review. The Obstetric Nurse Educator said that Patient #8's medical record did not contain an admission H&P examination.

The Nursing Service Condition of Participation was found out of compliance.

Findings included:

The Hospital failed for 1 of 14 sampled patients (Patient #1), to ensure that the Obstetric Nursing staff were competent in the Nursing care of high-risk Obstetric patients.

Refer to TAG: A-386

The Hospital failed to ensure that 2 of 2 contract nursing staff working at the Hospital and employed by the Corporation met the nursing licensing requirements.

Refer to TAG: A-394

The Hospital failed for 1 of 14 sampled patients (Patient #1) to ensure that the Nursing Staff developed a care plan for Patient #1's cardiovascular disease and signs and symptoms to monitor for an acute cardiovascular event.

The Hospital failed to follow the care plan monitor and or document intake and output, related to actual blood loss to determine the Patients' replacement needs and assist in early detection of hypovolemic shock (a life-threatening condition).

Refer to TAG: A-396

Based on records reviewed and interviews the Hospital failed to ensure that the 2 of 2 contract nursing staff were oriented to the Hospital's policies and procedures.

Refer to TAG: A-398

The Hospital's nursing staff failed to obtain and document an admission weight, required for accurately dosing intravenous medications; and monitor the Patient #1's response to medications administrated for persistent nausea and vomiting, which could indicate a myocardial infarction (a heart attack) or a medication side effect.

Refer to TAG: A- 405

Based on record reviews and interviews, for 3 of 14 sampled patients (Patients #1, #6 & #7), the Hospital failed to ensure that the Obstetric Nursing Staff were competent in the Nursing care of Obstetric patients for monitoring and quantifying actual blood loss with accurate intake and output records.

Findings included:

The Face Sheet, dated 2/12/18, indicated Patient #1 was admitted on 2/12/18 for induction of labor at 39 weeks pregnant (full-term).

The Surveyor interviewed the Chairperson of Obstetrics and Gynecology at 3:30 P.M. on 4/4/18. The Chairperson of Obstetrics and Gynecology said that the Hospital provided services for high risk maternity patients, this was not consistent with their transfer policy and the Hospital did not have guidelines for when a patient was considered high-risk.

The Hospital policy titled Maternal Transfer, dated 6/2015, indicated the decision was made by the attending physician or Certified Nurse Midwife in consultation with the physician to transfer patients premature labor, premature rupture of membranes, early gestational age, severe toxemia, severe diabetes or any high-risk patient.

The Nursing Staff failed to accurately monitor Intake and Output. Failed to assess Patient #1's quantitative blood loss to determine adequate blood and fluid replacement.

The Nursing Staff failed to ensure the Nursing staff followed procedures for recording Intake and Output.

The Hospital failed to ensure the Nursing staff followed procedures for recording Intake and Output.

The Hospital Policy, titled Obstetric Hemorrhage, dated 12/12/17, indicated that the policy was to identify early recognition of excessive blood loss in the peripartum period. Some of the predisposing factors to obstetric hemorrhage were prolonged labor, an operative delivery and drugs, including but not limited to general anesthesia, oxytocin and magnesium sulfate. Weigh all blood-stained items and deduct the weight of the dry items to calculate blood loss., 1 Gram is equivalent to 1 milliter (ml) of blood. The symptoms of an obstetric hemorrhage are decreased blood pressure and increased pulse (signs of shock) does not appear until hemorrhage is advanced (loss of 15% to 20% of total blood volume). The policy indicated Obstetric Staff weigh all bloodstained items and deduce the weight of the dry items to calculate an actual (quantified) blood loss (QBL) instead of an estimated blood loss (EBL). The policy indicated symptoms of an obstetric hemorrhage were hypovolemia, cold clammy skin, profound hypotension (blood pressure below 90/60), fear, anxiety and restlessness.

The Hospital's practice guideline, Lippincott Procedures, dated 2/16/18, for uterine atony (soft) management, indicated the American College of Obstetricians and Gynecologist (ACOG) defined postpartum hemorrhage as cumulative (total) blood loss (intrapartum and postpartum) of 1,000 ml or greater or blood loss accompanied by signs and symptoms of hypovolemia within 24 hours after cesarean or vaginal delivery.

The Hospital failed to determine Patient #1's Intake and Output per shift and then cumulative 24 hour a day for early detection of fluid volume depletion (fluid blood loss).

Lippincott Procedures (Hospital Nursing Standard of Practice), dated 5/12/17 for Intake and Output, indicated that many patients require fluid intake and output monitoring, including those undergoing surgery, those receiving intravenous therapy, and patients who were hemorrhaging. Intake and Output was essential in monitoring a patient's response to treatment. Measure Intake and Output in milliters and record it on a 24 hour Intake and Output record.

The Obstetrical Flow Sheets for Patient #1 (included Intake and Output (I &O) records), dated 2/12/18 (preoperatively) through 2/13/18 (perioperatively and postoperatively), indicated the cumulative patient Intake and Output for each shift was not added together (totaled) by Nurse #1 and Nurse #2 to compare if the output (i.e. blood loss, vomiting) exceeded the intake, to determine if fluid or blood replacement was needed.

The Obstetric Nurse Director said that the Patient #1's Intake and Output should be totaled each shift and then the cumulative value every 24 hours to detect early fluid loss but the shift (every 8 to 12 hours) 24 hour I & O was not done. The Obstetric Nurse Director said there was not an area on the I & O sheets for documenting the shift nor 24 hour I & O.

The Magnesium Policy, dated 12/12/17, indicated after the initial bolus of Magnesium sulfate, intravenous fluids should be limited to 125 milliters an hour, intravenous fluid rate may be varied based upon maternal fetal condition.

The Surveyor interviewed RN #2 at 10:45 A.M. on 4/18/18. RN #2 said preoperatively, she did not administer 1,000 milliters of intravenous fluids prior to Patient #1's epidural (catheter placed into the spine for medications for labor pain management), as requested by the Anesthesiologist (frequently done to counter the temporary neurological blocking with insertion of the epidural catheter), because Patient #1 was treated with Magnesium Sulfate and the Hospital policy required a fluid restriction. RN #2 said with Patient #1's swelling in her extremities, she did not have intravascular depletion, but had too much fluid and RN #2 did not want to overload Patient #1. RN #2 did not understand how Patient #1 could have inadequate fluid reserve (intravascular fluid depletion) when she had swelling in her extremities (3rd spacing).

The Hospital failed to ensure Nursing staff accurately monitored and recorded Patient #1's intraoperative and postpartum blood loss.

The Obstetrical Operative Note, dated at 5:24 P.M. on 2/13/18 indicated a primary Cesarean section was performed with an estimated blood loss of 1,000 milliters (ml), with no complications, but Patient #1's post-operative condition was documented as being serious.

The Anesthesia Record, dated at 3:25 P.M. on 2/13/18 indicated Patient #1 received 1500 milliters of intravenous fluids and had an estimated blood loss of 1,000 milliters (inconsistent with Hospital policy for Obstetric Hemorrhage).

The Nurse's Note, dated 2/13/18 at 5:00 P.M., indicated after Patient #1's cesarean section, clots were expressed from the uterus and various medications were to be administered.

The Surveyor interviewed the Obstetric Nurse Director at 2:08 P.M. on 4/4/18 and at 8:55 A.M. on 4/25/18. The Obstetric Director said that Patient #1 had bleeding from the cesarean section in the Operating Room and vaginal bleeding in the Postoperative Recovery Room. The Obstetric Nurse Director said intraoperatively, the Nurses needed to determine Patient #1's actual blood loss and not the estimated blood loss which was not accurate, many of the nurses were not compliant with determining actual blood loss for their patients.

The Anesthesia Record, dated 2/13/18, indicated at 3:25 P.M. Patient #1 entered the Operating Room, Patient #1's blood pressure decreased to 98/52 (low blood pressure) with a heart rate of 110 beats per minute (bpm) and the Anesthesiologist administered received 4 doses of Ephedrine and 4 doses of Phenylephrine (both medications for anesthesia induced hypotension (low blood pressure) or hypovolemia).

The Surveyor interviewed the Obstetric Medical Director, at 7:58 A.M. on 4/25/18. The Obstetric Medical Director said that the number and frequency of the vasoactive medications intraoperatively were give to treat Patient #1's need for fluid resuscitation.

The Anesthesia Record, indicated Patient #1 was transferred from the Operating Room to her room for recovery at 2/13/18 at 4:59 P.M.

The Nurse's Note, dated 2/13/18 at 5:35 P.M., indicated Patient #1's bleeding had become heavy and Patient #1 said I don't feel right, blood pressure 81/46 (low blood pressure). Physician called to the bedside, two clots were extracted manually the Physician and a Bakri (mechanical device inserted into the uterus to manage hemorrhage) balloon was placed. The Nurse's Note, dated at 6:00 P.M. on 2/13/18, indicated Patient #1's bleeding was stable after the Bakri balloon was placed.

Physician's order, dated at 6:19 P.M. on 2/13/18, indicated an order for 2 units of packed red blood cells for Patient #1's active bleeding and hypotension and transfuse 2 units within one hour.

The Surveyor interviewed RN #3 at 3:20 P.M. on 4/12/18. RN #3 said Patient #1 had a lot of vaginal bleeding after the Cesarean section and Patient #1's blood pressure dropped dramatically. RN #3 said Patient #1 received Carboprost Tromethamine and Misoprostol (medications to stop bleeding) and Physician #2 inserted a Bakri balloon into Patient #1's vagina. RN #3 said Patient #1 did not receive the ordered blood because Patient #1's hematocrit and hemoglobin (blood test and a late sign of acute blood loss) was normal. RN #3 said at approximately 7:30 P.M. Patient #1 was vomiting non-stop and Patient #1 complained of chest burning. RN #3 said she went back to Patient #1's room after approximately 15 minutes as Patient #1 reported shortness of breath, that she felt cold and Patient #1's oxygen levels and blood pressures had decreased. RN #3 said Physician #2 determined Patient #1 had an irregular heartbeat and Physician #2 requested the Obstetric Staff call the Hospital Emergency Response Team.

The Massive Blood Transfusion Protocol dated, 5/2016, indicated the massive blood transfusions were implemented for patients with acute and significant bleeding.

The ERT (Emergency Response Team) Report, dated 2/13/18, indicated blood as administered during cardiopulmonary resuscitation and 32 minutes after Patient #1 was without a heartbeat.

The Physician Notes, dated 2/13/18, indicated no documentation of fluid or blood product resuscitation replacement for maternal hemorrhage prior to Patient #1's cardiopulmonary arrest. (The blood was not administered until Patient #1's cardiopulmonary resuscitation).

The Physician Notes, dated 2/13/18, indicated no documentation of fluid or blood product resuscitation replacement for maternal hemorrhage prior to Patient #1's cardiopulmonary arrest.

The document titled Death Report, dated 2/13/18, indicated Patient #1's time of death as 9:12 P.M. on 2/13/18.

The Surveyors interviewed Registered Nurse (RN) #4 at 11:45 A.M. on 4/5/18, who stated that although she worked on the Post-Partum Unit, she did not receive the educational in-service training for determining actual blood loss.

The Surveyor interviewed the Obstetric Assistant Director at 12:15 P.M. on 4/5/18. The Obstetric Assistant Director said Nurse #3 was not measuring accurate blood loss consistent with Hospital policy.

Three (3) of 10 sampled patients (Patients #1, #6 and #7) Nursing Staff did not document accurate blood loss.

The Hospital failed to ensure that the Chief Nursing Officer, who was fully responsible for the operation of the Nursing Service, reviewed and approved 2 of 2 nursing care policies that pertained to nursing care on the Obstetrical Unit for Obstetric Hemorrhage and Magnesium Sulfate (a medication for preventing Seizures) administration.

The Policy titled, Obstetric Hemorrhage, dated 12/18/17, indicated the Chief Nursing Officer, did not review nor approve this policy, which included the Nursing Care for patients with early recognition of excessive blood loss.

The Policy titled, Magnesium Sulfate for Seizures Prophylaxis in Acute Onset Severe Hypertension with Preeclampsia and Eclampsia, dated 5/15/13, indicated the Chief Nursing Officer did not approve this policy which included the scope of Nursing practice and Nursing staffing for the administration of magnesium sulfate for seizure and hypertension.

The Chief Nursing Officer was interviewed at 9:20 A.M. on 4/5/18. The Chief Nursing Officer said there was no signature on the Obstetric Hemorrhage Policy nor the Magnesium Sulfate policy that indicated these policies were reviewed and approved by The Chief Nursing Officer.

Based on records reviewed and interviews, the Hospital failed to ensure that 2 of 2 contract nursing staff working at the Hospital and employed by the Corporation met the nursing licensing requirements.

Findings included:

The job descriptions for the Corporate Quality Manager and Corporate Quality Staff #1, indicated their job qualifications included that a Registered Nurse license was required.

The Surveyor reviewed 2 of 2 contract nursing personnel records of the Corporate Quality Manager and the Corporate Quality Staff #1, which indicated that they both did not have Massachusetts Nursing licenses.

The Surveyor interviewed the Human Resource Manager at 2:00 P.M. on 4/18/18, the Human Resource Manager said the Corporate Quality Manager and Corporate Quality Staff #1, did not have a Massachusetts Nursing license and worked in the Hospital, as required by their job descriptions.

Based on records reviewed and interviews the Hospital failed for 1 of 14 sampled patients (Patient #1) to ensure that the Nursing Staff developed a Care Plan for Patient #1's cardiovascular disease and signs and symptoms to monitor for early recognition of an acute cardiovascular event. The Hospital failed to ensure an accurate hand off (report) between Registered Nurse #1 and Registered Nurse #2 occurred for communicating Patient #1's new onset of chest pain and cardiovascular history. The Hospital failed to follow the care plan monitor and or document Intake and Output, related to actual blood loss to determine Patient #1's replacement needs and assist in early detection of hypovolemic shock.

Findings include:

Lippincott Procedures (Hospital Nursing Standard of Practice), dated 5/12/17 for Intake and Output, indicated that many patients require fluid intake and output monitoring, including those undergoing surgery, those receiving intravenous therapy, and patients who were hemorrhaging. Intake and Output was essential in monitoring a patient's response to treatment. Measure Intake and Output in milliters and record it on a 24 hour Intake and Output record.

The History & Physical, dated at 9:19 A.M. on 2/12/18, and Discharge Summary, dated at 6:27 P.M. on 2/26/18 indicated Patient #1 was admitted on 2/12/18 for induction of labor at 39 weeks pregnant (full-term) and diagnoses included: Gestational Diabetes Mellitus treated with insulin, gestational hypertension, obesity, severe pre-eclampsia (a condition in pregnancy characterized by high blood pressure, sometimes fluid retention and protein in the urine), elevated cholesterol and triglycerides (blood work indicating possible heart problems) and tobacco disorder with daily usage.

The Surveyors interviewed RN #1 at 8:20 A.M. on 4/18/18, the RN assigned to take care of Patient #1 on 2/12/18 during the 7:00 A.M. to 7:00 P.M. shift. RN #1 reviewed Patient #1's chart and said Patient #1 had a significant cardiovascular history and a family history of hypertension, a myocardial infarction and a cerebrovascular accident (which can be thrombotic events caused by blood clots). RN #1 said even though Patient #1 was at risk for a cardiac event (a heart attack, a stroke, or angina-when the arteries that supply blood to the heart provide an inadequate blood supply), there was no cardiovascular care plan for early recognition nor interventions for an acute cardiac event.

RN #1 said Patient #1 had a new complaint of left crampy calf pain and there was no assessment of the color size or temperature of the calf written. The Nurses Note indicated Patient #1 complained of shortness of breath at 10:42 A.M. on 2/12/18 and reported her new symptom to Physician #1.

RN #1 said when Patient #1 had breathing problems, she said I am having difficulty breathing and I am having a hard time breathing. RN #1 demonstrated how Patient #1 held her right hand over her chest with the shortness of breath and she was sitting bolt upright and required 10 liters of oxygen, which was not normal. RN #1 said that Patient #1 was a high-risk patient, which we usually don't take care of patients this complex.

Physician #1's Note, dated 2/12/18, at 11:07 A.M., a late entry, indicated on admission Patient #1 had elevated blood pressures in the 160's/90's range. No further cardiac assessment was performed to rule out an acute cardiac event.

The Surveyors interviewed RN #2 at 10:45 A.M. on 4/18/18. RN #2 stated that she had not been given report that Patient #1 had chest pain on the previous shift and was unaware that Patient #1 had a cardiovascular history. (An inaccurate hand off between the Nurses for communicating essential information needed providing an adequate plan of care.)

Review of Patient #1's care plan for alteration in fluid volume, excess or deficit, dated 2/12/18, indicated to monitor Intake and Output and imbalances.

The Surveyors interviewed the Obstetric Nurse Director at 2:08 P.M. on 4/4/18. The Obstetric Director said that Patient #1 had vaginal bleeding in the Operating Room and in the Postoperative Recovery Room. The Obstetric Nurse Director said that for Patient #1's case, it was identified that the Nurses needed to determine Patient #1's actual blood loss and not the estimated blood loss which is not accurate.

The Nurse's Note, dated 2/13/18 at 6:25 P.M., indicated Patient #1 was nauseated and vomiting since the procedure (unclear which procedure, the Cesarean section at 3:52 P.M. or the Bakri balloon placement at 5:35 P.M.) and complaining of midline chest pain and burning feelings (a 1-1/2 difference). The Physician was present at the bed side, intramuscular Phenergan (nausea medication) ordered, and intravenous Pepcid (medication for indigestion) were given.

The Medication Administration Record, dated 2/13/18, indicated the following anti-nausea and vomiting medications were ordered without a documented response (relief or continuation of the midline chest pain and burning feelings symptoms and the action taken, and Physician notification):
-Phenergan (medication for nausea) administered at 6:27 P.M.,

-Pepcid (medication for indigestion) administered at 6:45 P.M., and

-Calcium Carbonate (Tums) at 2/13/18 at 7:35 P.M. ordered at 7:35 P.M. and not documented as administered.

The Nursing Staff administered 2 different anti-nausea medications and the 3rd anti-nausea medication was ordered but not documented as administered from 6:27 P.M. to 7:35 P.M., over a one hour period, there was no documentation to indicate Nursing Staff called the Physician when the medications administered were not effective. There was no documentation of Patient #1's midline chest pain.

The Surveyors interviewed Hospital Quality Assurance #1 at 12:20 P.M. on 4/18/18. Hospital Quality Assurance #1 said that, for the 3 anti-nausea and vomiting medications, the Nurses nor the Physicians documented whether these medications were effective.

Nurses Note, dated 2/13/18 at 7:55 P.M., indicated Patient #1 felt cold (likely an imminent sign of cardiac and respiratory failure) and she was desaturating in the 70's (oxygen saturation indicated inadequate oxygenation, normal greater than 90%). Patient #1 received supplemental oxygen with a non-rebreather mask (an oxygen delivery device to deliver a higher concentration of oxygen than an oxygen face mask for patients with a severe and deteriorating ability to breathe). Nurses Nurse indicated Patient #1 received 10 liters of oxygen and her oxygen saturations were unstable and ranging from 70% to 90% (significantly insufficient oxygen in her blood), with tachycardia (fast heart rate, normal less than 100) in the 130's, blood pressure 80/60 (very low) and a an Rapid Response Team (RRT) was called as Patient #1's condition continued to decline.

The Emergency Response Team (ERT) Sheet, dated 2/13/18, indicated an emergency response team was called at 8:13 P.M. and heart rhythm evaluation was performed using a cardiac monitor (approximately 34 hours after Patient #1's complaint of chest pain on 2/12/18 at 10:42 A.M. and 1-1/2 hours after Patient #1's complain of chest pain at 6:35 P.M. on 2/13/18). Patient #1 had a respiratory arrest at 8:28 P.M., and a cardiopulmonary arrest at 8:30 P.M. and the cardiac rhythm was ventricular tachycardia (an ineffective and life-threatening heartbeat), at 8:38 P.M. ventricular fibrillation (a heartbeat more serious than ventricular tachycardia) and she progressed to asystole (death).

An Electro-Cardiogram (ECG), dated at 8:21 P.M. during Patient #1's cardiopulmonary arrest, indicated Patient #1 had an acute myocardial infarction (heart attack).

The Surveyor interviewed Cardiologist #1 at 4:40 P.M. on 4/25/18. Cardiologist #1 said Patient #1 had an acute myocardial infarction.

The Nurse's Note, dated at 5:00 P.M. on 2/13/18, indicated post Cesarean section clots were expressed from the uterus and various medications were to be administered.

The Nurse's Note, dated 2/13/18 at 5:35 P.M., indicated Patient #1 Patient's bleeding had become heavy and Patient #1 said I don't feel right, blood pressure 81/46 (low blood pressure). The Nurse's Note indicated a Physician was called to the bedside, two clots were extracted manually by the Physician and a Bakri (a balloon device to create tamponade) balloon was placed.

The Nurse's Note, dated 2/13/18, at 6:00 P.M., indicated Patient #1's bleeding was stable after the Bakari balloon was in placed with a firm fundus (uterus) and BP 120/49.

Physician's order, dated 2/13/18 at 6:19 P.M. for 2 units of packed red blood cells for Patient #1's active bleeding and hypotension and transfuse 2 units within one hour. (But not administered)

The Surveyor interviewed the Obstetric Medical Director at 3:30 P.M. on 4/4/18. The Obstetric Medical Director said Patient #1's intraoperative blood loss of an estimated 1000 milliters, (considered an obstetrical hemorrhage) and there was post operatively bleeding. The Obstetric Medical Director said their standard of practice was not to estimate blood loss but to perform a quantitative blood loss to ensure adequate fluid volume replacement with fluid resuscitation or needed blood transfusion to prevent hypovolemia (which can lead to hypovolemic shock).

Based on records reviewed and interviews the Hospital failed to ensure 2 of 2 contracted Nursing Staff were oriented to the Hospital's policies and procedures.

Findings included:

The Surveyor reviewed 2 of 2 contract nursing personnel records of the Corporate Quality Manager and Corporate Quality Staff #1, which indicated that both did not have orientation to the Nursing service, emergency and safety policies and procedures.

The Surveyor interviewed the Human Resource Manager at 2:00 P.M. on 4/18/18, the Human Resource Manager at 2:00 P.M. on 4/18/18. The Human Resource Manager said the Corporate Quality Manager and Corporate Quality Staff #1, did not have an orientation to the Hospital.

Based on interviews and documentation review for 1 of 14 sampled patients (Patient #1), the Hospital's nursing staff failed to ensure acceptable standards of practice were followed for the administration of medication. The Hospital's nursing staff failed to obtain and document an admission weight, required for accurately dosing intravenous medications; and monitor the patient's response to medication administrated for persistent nausea and vomiting, which could indicate a myocardial infarction (a heart attack) or a medication side effect.

Findings include:

Lippincott Procedures (the Hospital's practice guideline), dated 11/17/17 for Safe medication administration, indicated that to ensure accurate dosage calculations, make sure the patient's most recent weight (in kilograms) is documented in the medical record to enable accurate dosage calculations related to weight. The guideline indicated to calculate the correct dosage of ordered medications using weight-based dose schedules and for completing the procedure for medication administration, monitor and document the effectiveness of all medications administered.

The Hospital policy, Medication Management, dated 10/2016, indicated that the patient's weight and height are the responsibility of the Nurse to be entered into the computer when a patient is admitted. The Hospital policy indicated for the first dose of medications it is noted through assessment the nurse will provide education and monitor for the effects of the medication. The Hospital policy indicated that the Nurse would monitor medications that were administered and this included perceived efficacy (if worked). The Hospital policy indicated monitoring of medications was ongoing and was documented in the medical record. The Hospital policy indicated that the Nurse would assess and document pertinent information in the medical record assessments, patient side effects and or the clinical response.

The American Heart Association, dated 2018, indicated the heart attack symptoms for women may include:
- uncomfortable pressure, squeezing
- fullness or pain in the center of the chest
- lasting more than a few minutes and then goes away and comes back
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or lightheadedness.
Women were somewhat more likely than men to experience some of the other common symptoms, particularly shortness of breath, nausea/vomiting and back or jaw pain.

The History & Physical, dated at 9:19 A.M. on 2/12/18, and Discharge Summary, dated at 6:27 P.M. on 2/26/18 indicated Patient #1 was admitted on 2/12/18 for induction of labor at 39 weeks pregnant (full-term) and diagnoses included: Gestational Diabetes Mellitus treated with insulin, gestational hypertension, obesity, severe pre-eclampsia (a condition in pregnancy characterized by high blood pressure, sometimes fluid retention and protein in the urine), elevated cholesterol and triglycerides (blood work indicating possible heart problems) and tobacco disorder with daily usage.

The Document titled Meditech Screen Shot, dated 4/12/18, indicated a blank Meditech Screen Shot (electronic medical record documentation system) where nursing personnel documented a patient Weight in Pounds, the Weight Measurement Method as a Stated Weight and where nursing personnel documented the Reason for No Actual Weight.

The Surveyors interviewed Nurse Director #1, at 10:20 A.M. on 4/12/18. The Nurse Director said nursing personnel entered a patient weight into the Meditech systemand the system automatically converted the patient weighted in pounds to a weight in kilograms. The Nurse Director said that if nursing personnel were unable to obtain an actual weight, then nursing personnel were required to document the reason.

The Nurse's Note, dated at 6:25 P.M. on 2/13/18, indicated Patient #1 was nauseous and vomiting since the procedure and complaining of midline chest pain and burning feelings. The Nurse's Note indicated the Physician was present at the bed side, intramuscular Phenergan ordered, and intravenous Pepcid were given.

The Medication Administration Record, dated 2/13/18, indicated the following anti-nausea and vomiting medications were ordered without a documented response (relief or continuation of the midline chest pain and burning feelings symptoms and the action taken, and Physician notification):

-Phenergan (medication for nausea) administered at 6:27 P.M.,

-Pepcid (medication for indigestion) administered at 6:45 P.M., and

-Calcium Carbonate (Tums) at 2/13/18 at 7:35 P.M. ordered at 7:35 P.M. but not documented as administered.

The Surveyors interviewed Hospital Quality Assurance #1 at 12:20 P.M. on 4/18/18. Hospital Quality Assurance said that for the 3 anti-nausea and vomiting medications the Nurses did not document whether these medications were effective or ineffective.

Physician #1's Note, dated 2/12/18, at 11:07 A.M., a late entry, indicated after a bolus of Magnesium Sulfate 6 milligrams. Patient #1 had temporarily developed a feeling of chest pressure, lungs were clear, oxygen saturation 97 and 98% on room air. Laboratory blood work indicated elevated protein: creatinine ratio, indicative of a diagnosis of pre-eclampsia. Magnesium Sulfate (medication) was started to reduce the risk of seizures. After a loading dose of Magnesium Sulfate 6 milligrams, Patient #1 had chest pressure and shortness of breath. Patient #1 started spontaneously to feel better.

The Surveyor interviewed Registered Nurse (RN) #1 assigned to take care of Patient #1 on 2/12/18 during the 7:00 A.M. to 7:00 P.M. shift. RN #1 reviewed Patient #1's chart and said Patient #1 had a significant cardiovascular history and a family history of hypertension, a myocardial infarction and a cerebrovascular accident (which can be thrombotic events caused by blood clots). RN #1 demonstrated how Patient #1 held her right hand over her chest with the shortness of breath and she was sitting bolt upright and required 10 liters of oxygen, which was not normal.

The Surveyor interviewed the Chairperson of Obstetrics and Gynecology at 3:30 P.M. on 4/4/18. The Chairperson of Obstetrics and Gynecology said that Patient #1 was high risk due to hypertension, gestational diabetes, pre-eclampsia, a long induction which did not progress, and resulted in a C-section. Chairperson of Obstetrics and Gynecology said postoperatively Patient #1 had a seizure and a uterine hemorrhage with a decline in her condition, she became unresponsive, and a rapid response team (and later, the emergency code team) performed resuscitation efforts which were unsuccessful. Chairperson of Obstetrics and Gynecology said Patient #1 died on 2/13/18 at 9:12 P.M.