HospitalInspections.org

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

Findings included:

1.) The Hospital failed to ensure for one (Patient #1) patient out of ten sampled patients, that Hospital QAPI activities analyzed and implemented procedures after Patient #1's death in accordance with the Hospital's Quality and Patient Safety Improvement Program (Plan) and Completion of a Root Cause Analysis (RCA) policy.

Refer to TAG: A-0273.

2.) The Hospital failed to ensure for two patients (Patients #1 & #3) out of ten sampled patients that Hospital QAPI activities identified opportunities for improvement and changes that would lead to improvement in the quality of care for high-risk obstetric patients that unexpectedly presented to the Hospital Emergency Department.

Refer to TAG: A-0283.

3.) The Hospital failed to ensure for one patient (Patient #1) patient of out of ten sampled patients that Hospital QAPI activities analyzed and implemented procedures for transfer of high-risk obstetric patients that arrived at the Hospital for a pending delivery.

4.) The Hospital failed to ensure for two patients (Patients #1 & #3) out of ten sampled patients that QAPI activities thoroughly analyzed Patient #1's adverse patient event, a maternal death, implement preventive actions and mechanisms that included feedback and learning as applicable throughout the Hospital.

Refer to TAG: A-0286.

5.) The Hospital Governing Body failed to ensure for two patients (Patients #1 & #3) out of ten sampled patients, the full responsibility of Hospital operations including the Medical Staff and that hospital-wide quality assessment and performance improvement efforts addressed priorities for improved quality of obstetric care.

Refer to TAG: A-0309.

Based on records reviewed and interviews the Hospital failed to ensure, for one patient (Patient #1) out of ten sampled patients, that the Hospital Quality Assessment & Performance Activities (QAPI) Program analyzed and implemented procedures for improvement after Patient #1's death in accordance with the Hospital's Quality and Patient Safety Improvement Program and completion of a Root Cause Analysis (RCA-a process of adverse patient event analysis)policy.

Findings included:

The Hospital document titled Quality and Patient Safety Improvement Program, dated 2/2019, outlined the Hospital's Quality Improvement and Performance Plan. The QAPI Program indicated the Chief Quality Officer was responsible for ensuring the process for internal reviews and that corrective and preventative actions were carried out and measured for effectiveness.

The Hospital policy titled Completion of a Root Cause Analysis, dated 4/2019, indicated the Hospital analyzed high-risk events through the process of an RCA and high-risk events included unanticipated patient outcome and or an opportunity for systems improvement.

The Surveyor interviewed the Vice President of Medical Affairs at 9:00 A.M. on 9/30/19. The Vice President of Medical Affairs said Patient #1 presented to the Hospital Emergency Department by Emergency Medical Services (EMS, ambulance) in labor and ready to deliver. The Vice President of Medical Affairs said that Patient #1 was a patient of another hospital with a high-risk obstetric service due to Patient #1's high-risk obstetric status for the need for Lovenox (blood thinner medication).

The Discharge Summary, dated 9/2/19, indicated Patient #1 had a history of deep vein thrombosis (DVT-a clot) and stroke. The Discharge Summary indicated Patient #1's post-partum Cesarean section course was remarkable for hemorrhage from rupture of the vaginal wall while on a blood thinning medication. The Discharge Summary indicated Patient #1's vital signs were unstable, Patient #1 was was in kidney failure and cardiopulmonary arrest requiring resuscitation prior to Patient #1's death.

The Vice President of Medical Affairs said that the Medical Staff conducted a Peer Review (case review conducted by physicians) that determined that the standard of care was met. The Vice President of Medical Affairs said the Hospital did not conduct an RCA.

Based on records reviewed and interviews the Hospital failed to ensure, for two patients (Patients #1 & #3) out of ten sampled patients, that Hospital Quality Assessment & Performance Improvement (QAPI) activities identified opportunities for improvement and changes that would lead to improvement in the quality of care of high-risk obstetric patients that unexpectedly presented to the Hospital Emergency Department.

Findings included:

1.) Hospital QAPI activities failed to ensure appropriate documentation of a consultation regarding Patient #1's anticoagulant (blood thinner) medication, with Patient #1's high-risk obstetric providers.

The Surveyor interviewed the Chief of Obstetrics at 12:30 P.M. on 9/3/19. The Chief of Obstetrics said the Hospital did not have Patient #1's official history; however, the Hospital knew that Patient #1 had a history of a previous Cesarean section, stroke, Patent Foramen Ovale [PFO, an incomplete closure of the atrial septum (top two heart chambers) that may cause maternal stroke by allowing blood clots to travel to the brain. Clinically PFO is thought to increase the risk of stroke, pulmonary embolism and heart attack during pregnancy and post-partum], was on an anticoagulant medication and Patient #1's providers did not know the dose of the anticoagulant medication. The Chief of Obstetrics said that neither he nor the provider caring for Patient #1 could identify the person at the high-risk obstetric service hospital that verbally provided the dose for Patient #1's anticoagulant medication. The Chief of Obstetrics said the Hospital did not have consultation notes from the high-risk obstetric service that provided Patient #1's obstetric care.

The Hospital Medical Staff provided no documentation, process or plan to accurately record in a high-risk obstetric patient's medical record, treatment conversations conducted with the providers managing the patient's obstetric care at the high-risk obstetric service hospital, including medications, provider name and qualifications.

2.) Hospital QAPI activities failed to identify qualifications of the Intensive Care Unit (ICU) staff to care for high-risk obstetric patients and implement educational opportunities.

The document titled Management of the Critically Ill Obstetric Patient, https://www.ncbi.nlm.nih.gov/pubmed/21841145, indicated hypertensive disorders, postpartum hemorrhage, and sepsis were the most common indications for intensive care unit admission among obstetric patients and provision of care to this special population required an intimate understanding of physiologic changes that occur during pregnancy.

The Hospital policy titled Care of the Critically Ill Obstetric Patient, dated 8/2019, indicated the Hospital cared for critically ill obstetric patients. The policy indicated nursing staff roles between Intensive Care Unit nursing staff and obstetric unit nursing staff for care of critically ill obstetric patients intra-partum (before delivery) and post-partum (after delivery). The policy indicated the roles of the post-partum obstetric staff included evaluation and documentation of maternal fundal (uterine) height and lochia (bleeding) and standard recovery for either vaginal or cesarean section deliveries for two hours. The policy indicated standard obstetric medication administration was coordinated with the Intensive Care Unit Registered Nurse and the obstetric staff assisted with the obstetric hemorrhage protocol, insertion of the Bakri balloon (intra-vaginal obstetric device used to manage post-partum hemorrhage), administration and documentation of hemorrhagic specific medications. The policy indicated Intensive Care Unit nursing staff roles included admission, documentation, electrocardiogram and vital sign evaluation, routine Intensive Care Unit management, and medication administration. The policy indicated Intensive Care Unit nursing staff roles included the provision of supportive care and maintenance of patient stability during obstetric procedures.

The document titled, What are some common complications of pregnancy?, https://www.nichd.nih.gov/health/topics/pregnancy/conditioninfo/complications, indicated complications of pregnancy included high blood pressure, diabetes, and infections.

The document titled High-Risk Pregnancy, https://www.nichd.nih.gov/health/topics/high-risk/conditioninfo/factors, indicated several factors can make a pregnancy high-risk, including existing health conditions (high blood pressure, obesity), the mother's age (young age (teens) and first-time pregnancy after age 35) lifestyle (alcohol use, tobacco use, drug use) and health issues that happen before or during pregnancy [multiple gestation, pre-eclampsia (toxemia of pregnancy) and eclampsia, previous preterm birth, birth defects or genetic conditions in the fetus].

The Surveyor interviewed Registered Nurse #1 at 9:00 A.M. on 9/3/19. Registered Nurse #1 said that obstetric nurses evaluate obstetric patients when the obstetric patient was admitted to the ICU. Registered Nurse #1 said that the obstetric nurses evaluated the post-partum patient's fundus (uterus) and flow (bleeding), fetal heart rates (pregnant women) and breastfeeding for women in the ICU longer than ten days.

The policy titled Care of the Critically Ill Obstetric Patient, indicated no role responsibilities of the Intensive Care Unit staff to evaluate hypertensive disorders, postpartum hemorrhage, sepsis, and provision of care as this special population required an intimate understanding of physiologic changes that occur during pregnancy. The policy indicated no role responsibilities of the Intensive Care Unit staff to evaluate the critically ill obstetric patient for complications of pregnancy and a high-risk pregnancy.

The Surveyor interviewed Registered Nurse #2 at 10:00 A.M. on 9/3/19. Registered Nurse #2 said that she worked in the ICU, did not have obstetric critical care experience and that the Hospital did not offer obstetric critical care education.

Registered Nurse #2's personnel file indicated no critical care obstetric education for high-risk obstetric patient care or complications of pregnancy.

The Surveyor interviewed Intensivist (Physician) #1 at 10:30 A.M. on 9/3/19. Intensivist #1 said the medical staff and nursing staff had excellent experience with critical care.

The Surveyor interviewed Registered Nurse #3 at 11:00 A.M. on 9/3/19. Registered Nurse #3 said she worked in the ICU, did not have obstetric critical care experience except for the patients admitted to the ICU at the Hospital. Registered Nurse #3 said that she did not remember any specific critical care education offered by the Hospital. Registered Nurse #3 said that fibrinogen (a blood factor responsible for the clotting of blood) levels were not normally followed in the ICU and that the ICU did not deal with Disseminated Intravascular Coagulation, [DIC-a life-threatening condition of widespread blood clotting (coagulation) throughout the body's small blood vessels and the most common cause of an abnormal hemorrhage tendency during pregnancy. DIC is an emergency in pregnant women as it can lead to bleeding, organ failure and death because of the depletion of platelets and blood clotting factors. DIC is a complication of childbirth or surgery where its presence in a pregnant patient invariably is evidence of an underlying obstetric disorder] often and that she would need to look it up (research the significance of DIC and obstetrics).

The Surveyor interviewed the Chief of Obstetrics at 12:30 P.M. on 9/3/19. The Chief of Obstetrics said he was not aware if the ICU staff were qualified in critical care obstetrics.

The Surveyor interviewed the ICU Nurse Manager at 1:00 P.M. on 9/3/19. The ICU Nurse Manager said that the Hospital was a small community Hospital that rarely cared for critically-ill obstetric patients.

The Care of the Critically Ill Obstetric Patient policy indicated no guideline or criteria for expert obstetric consultation for evaluation of obstetric hemodynamics related to complications of pregnancy in critically ill obstetric patients.

3.) Hospital QAPI Activities failed to evaluate Emergency Department documentation of obstetric assessments.

The Hospital policy titled Transfer of Maternity Patients, dated 12/2017, indicated that all patients presenting in potential labor, all patients greater than 20 weeks gestation presenting in potential labor, would be evaluated by an Emergency Department nurse and once determined to be stable for transport would be transferred to Labor and Delivery for evaluation and management.

The Surveyor interviewed the Vice President of Medical Affairs and Chief of the Emergency Department at 5:15 P.M. on 9/3/19. The Vice President of Medical Affairs and Chief of the Emergency Department said that obstetric patients that presented to the Emergency Department were evaluated and triaged (medical term for the assignment of degrees of urgency to treat patient illnesses), patients with abnormal signs or symptoms or laboratory findings were transferred to Labor & Delivery triage. The Vice President of Medical Affairs and Chief of the Emergency Department said these obstetric patients were not registered in the Emergency Department, there were no notes in writing (documentation in the medical record of the Emergency Department triage evaluation) and the transfer communication to Labor & Delivery from the Emergency Department was verbal.

Medical Record review indicated two patients (Patients #1 & #3) of ten sampled patients indicated no patient care evaluation documentation from Emergency Department staff.

The Surveyor interviewed the Vice President of Medical Affairs at 9:00 A.M. on 9/30/19. The Vice President of Medical Affairs said Patient #1 presented to the Hospital Emergency Department by Emergency Medical Services (EMS, ambulance) in labor and ready to deliver.

The Surveyor interviewed the Quality Improvement Director at 8:00 A.M. on 9/3/19 and the Vice President of Medical Affairs at 9:00 A.M. on 9/30/19. The Quality Improvement Director said Patient #1's medical record contained no documentation from the emergency department physician or nursing staff.

Patient #1's medical record indicated no documentation Patient #1's evaluations in the Emergency Department.

The Report titled Obstetric (OB) in Emergency Department (ECC, Emergency Care Center) indicated Patient #3 presented to the Emergency Department. The Report indicated Patient #3 reported to be approximately twenty weeks pregnant and an Emergency Department Registered Nurse transported Patient #3 to Labor & Delivery. The Report indicated Patient #3 complained of abdominal pain, Labor & Delivery staff examined Patient #3 as not pregnant and transported Patient #3 back to the Emergency Department.

Patient #3's medical record indicated no documentation Patient #3's presentation to the Emergency Department.

Based on records reviewed and interviews the Hospital failed to ensure for two patients (Patients #1 & #3) of ten sampled patients that Hospital Quality Assessment & Performance (QAPI) activities thoroughly analyzed Patient #1's adverse patient event, a maternal death, implement preventive actions and mechanisms that included feedback and learning as applicable throughout the Hospital.

Findings included:

1.) Hospital Quality Assessment and Performance Activities failed to conduct a Root Cause Analysis in accordance with Hospital policy after Patient #1's death.

The Hospital policy titled Completion of a Root Cause Analysis, dated 4/2019, indicated the Hospital analyzed high-risk events through the process of Root Cause Analysis and high-risk events included unanticipated patient outcome and or an opportunity for systems improvement.

The Surveyor interviewed the Quality Improvement Director at 8:00 A.M. on 9/3/19 and the Vice President of Medical Affairs at 9:00 A.M. on 9/30/19. The Quality Improvement Director and the Vice President of Medical Affairs said the Hospital did not conduct a Root Cause Analysis (a process of adverse patient event analysis).

2.) Hospital QAPI activities failed to analyze the Hospital's transfer policies and practices regarding a critically ill obstetric patient.

Hospital policy titled Care of the Critically Ill Obstetric Patient, dated 8/2019, indicated the Hospital cared for critically ill obstetric patients.

The Vice President of Medical Affairs said that the topic to transfer Patient #1 to the hospital that provided Patient #1's high-risk obstetric care was not raised (discussed). The Vice President of Medical Affairs said that he did not know if the medical staff would conduct a more in-depth discussion regarding obstetric transfer should another high-risk obstetric patient present to the Hospital Emergency Department in labor and delivery was eminent.

3.) Hospital QAPI activities failed to analyze Hospital documentation policies and practices.

The Quality Improvement Director said that Patient #1's medical record contained no documentation from the emergency department physician or nursing staff. The Quality Improvement Director said that the Hospital had no policy or procedure regarding emergency department evaluation and documentation of obstetric patients that presented to the emergency department transferred to Labor & Delivery for an imminent delivery.

Medical record review indicated five obstetric patients (Patients #1 & #3) presented to the Emergency Department with no patient care evaluation documentation from emergency department staff.

Based on records reviewed and interviews the Hospital Governing Body failed to ensure for two patients (Patients #1 & #3) of ten sampled patients, the full responsibility of Hospital operations including the Medical Staff and that hospital-wide Quality Assessment & Performance Improvement (QAPI) efforts addressed priorities for improved quality of obstetric care.

Findings included:

1.) The Hospital failed to be fully responsible for quality assessment and performance improvement efforts addressed for improved quality of obstetric care regarding conducting a Root Cause Analysis after Patient #1's death, in accordance with Hospital policy.

The Hospital policy titled Completion of a Root Cause Analysis, dated 4/2019, indicated the Hospital analyzed high-risk events through the process of Root Cause Analysis and high-risk events included unanticipated patient outcome and or an opportunity for systems improvement.

The Surveyor interviewed the Quality Improvement Director at 8:00 A.M. on 9/3/19 and the Vice President of Medical Affairs at 9:00 A.M. on 9/3/19. The Quality Improvement Director and the Vice President of Medical Affairs said the Hospital did not conduct a Root Cause Analysis after Patient #1's unanticipated patient outcome-death.

2.) The Hospital failed to be the fully responsible for QAPI efforts addressed for improved quality of obstetric care regarding transfer of high-risk obstetric patients that arrived at the Hospital for a pending delivery.

The Commonwealth of Massachusetts Department of Public Health Hospital License, dated 10/31/18, indicated the Hospital was licensed to provide low-risk Obstetric Services.

The Surveyor interviewed the Vice President of Medical Affairs at 9:00 A.M. on 8/30/19. The Vice President of Medical Affairs said that the physicians that provided Patient #1's care in the intensive care unit were experienced with high-risk patient post-operative complication. The Vice President of Medical Affairs said that the topic to transfer Patient #1 to the hospital that provided Patient #1's high-risk obstetric care was not raised (discussed). The Vice President of Medical Affairs said that he did not know if the medical staff would conduct a more in-depth discussion regarding obstetric transfer should another high-risk obstetric patient present to the Hospital Emergency Department in labor and delivery was eminent. The Vice President of Medical Affairs said the medical staff did not have a thorough discussion about transfer and Patient #1 remained a high-risk obstetric patient.

The Surveyor interviewed the Chief Nursing Officer at 9:50 A.M. on 8/30/19. The Chief Nursing Officer said that the medical staff had opportunities to transfer Patient #1. The Chief Nursing Officer said that physicians covered (in Hospital) Intensive Care Unit eight hours a day and that the Hospital was moving to twenty-four-hour (in-Hospital) coverage with physicians or nurse practitioners indicating that the Hospital did not have twenty-four-hour provider coverage for critically ill high-risk obstetric patients in a community hospital with a low-risk obstetric service.

The Surveyor interviewed Registered Nurse #1 at 9:00 A.M. on 9/3/19. Registered Nurse #1 said that Patient #1 was an obese patient and that staff had difficult moving Patient #1 and had to use a different elevator to accommodate the birthing-bed because staff had difficulty transferring Patient #1 to a stretcher due to Patient #1's habitus.

The Surveyor interviewed Registered Nurse #2 at 10:00 A.M. on 9/3/19. Registered Nurse #2 said there was no discussion of transferring Patient #1. Registered Nurse #2 said the Hospital had no criteria for when a physician was required to be in-house (in the Hospital responsible for patients in the Intensive Care Unit) and there should be.

The Surveyor interviewed Intensivist (Physician) #1 at 10:30 A.M. on 9/3/19. Intensivist #1 said he cared for Patient #1 in the Intensive Care Unit. Intensivist #1 said he was Board Certified in Pulmonary, Sleep, Hospice & Palliative Care, and Internal Medicine. Intensivist #1 said the medical staff and nursing staff had excellent experience with critical care. Intensivist #1 said critical care is critical care, blood loss is blood loss, the same standard principles apply and fairly typical independent of discipline, critical care or obstetrics. Intensivist #1 said Patient #1 had a history significant for hypertension and stroke. Intensivist #1 said that Patient #1 had a pelvic hemorrhage from a ruptured vaginal wall. Intensivist #1 said he treated Patient #1 for decreased blood pressures with a plan for dialysis due to renal (kidney) failure prior to Patient #1's death. Intensivist #1 said there was no thought to transfer Patient #1 and Patient #1 was too unstable for transfer.

The Surveyor interviewed the Chief of Obstetrics at 12:30 P.M. on 9/3/19. The Chief of Obstetrics said the Hospital did not have Patient #1's official history; however, the Hospital knew that Patient #1 had a history of a previous Cesarean section, stroke, Patent Foramen Ovale [PFO, an incomplete closure of atrial septum (top two heart chambers) that may cause maternal stroke by allowing blood clots to travel to the brain. Clinically PFO is thought to increase the risk of stroke, pulmonary embolism and heart attack during pregnancy and post-partum], was on an anticoagulant (blood thinning) medication and did not know the dose of the anticoagulant medication. The Chief of Obstetrics said that neither he nor the provider caring for Patient #1 could identify the person at the high-risk obstetric service hospital that verbally provided the dose for Patient #1's anticoagulant medication. The Chief of Obstetrics said the Hospital did not have consultation notes from the high-risk obstetric service that provided Patient #1's obstetric care.

The Surveyor interviewed the Intensive Care Unit (ICU) Nurse Manager at 1:00 P.M. on 9/3/19. The ICU Nurse Manager said that ICU nursing staff and herself questioned the ICU Intensivists about transferring Patient #1. The ICU Nurse Manager said that the Intensivist replied, "she'll be fine". The ICU Nurse Manager said that Patient #1 was stable for transfer for approximately 12 hours between Patient #1's transfer from the Post Anesthesia Care Unit (PACU, Recovery Room after the Cesarean section) and prior to Patient #1's requirement for low blood pressure increase while in the ICU post-operatively.

The Surveyor interviewed the Obstetric Nurse Manager at 1:30 P.M. on 9/3/19. The Obstetric Nurse Manager said that the obstetric unit cared for low-risk post-partum patients.
Hospital policy titled Management, Identification of High-Risk Mothers & Newborns, dated 5/2018, indicated patients with pregnancy induced hypertension and or medical surgical complications required consultation and or transfer to a high-risk center (hospital with a high-risk obstetric service).

Hospital policy titled Care of the Critically Ill Obstetric Patient, dated 8/2019, indicated the Hospital cared for critically ill obstetric patients. The Care of the Critically Ill Obstetric Patient indicated nursing staff roles between ICU nursing staff and obstetric unit nursing staff for care of critically ill obstetric patients intra-partum (before delivery) and post-partum (after delivery). The Care of the Critically Ill Obstetric Patient policy indicated no guideline or criteria for expert obstetric consultation. The Care of the Critically Ill Obstetric Patient policy indicated no guidelines or criteria for transfer to a high-risk obstetric service.

The Hospital provided no medical staff or hospital review of Patient #1's care, despite Patient #1's high-risk obstetric conditions that included prior deep vein thrombosis, cerebral vascular accident (stroke), obesity, patient foramen ovale and of African American heritage regarding transferring Patient #1. The Hospital provided no medical staff or Hospital documentation regarding plans for managing high-risk obstetric patients that presented to the Hospital Emergency Department, in labor and in imminent delivery.

3.) The Hospital failed to be responsible for QAPI activities for improved quality of obstetric care regarding provider consultations.

The Surveyor interviewed the Vice President of Medical Affairs at 9:00 A.M. on 9/30/19. The Vice President of Medical Affairs said that Patient #1 was a patient of another hospital with a high-risk obstetric service due to Patient #1's high-risk obstetric status for the need for Lovenox (blood thinner medication). The Vice President of Medical Affairs said Patient #1 had a spontaneous (vaginal) rupture from Lovenox.

The Surveyor interviewed the Chief of Obstetrics at 12:30 P.M. on 9/3/19. The Chief of Obstetrics said the Hospital did not have Patient #1's official history, however the Hospital knew that Patient #1 was on an anticoagulant (blood thinning) medication and Patient #1's providers did not know the dose of the anticoagulant medication. The Chief of Obstetrics said that neither he nor the provider caring for Patient #1 could identify the person at the high-risk obstetric service hospital that verbally provided the dose for Patient #1's anticoagulant medication. The Chief of Obstetrics said the Hospital did not have consultation notes from the high-risk obstetric service that provided Patient #1's obstetric care.

4.) The Hospital failed to be responsible for QAPI activities addressing Emergency Department documentation of obstetric care.

Medical Record review indicated two obstetric patients (Patients #1 & #3) presented to the Emergency Department with no patient care evaluation documentation from Emergency Department staff.

5.) The Hospital failed to be responsible for QAPI activities for improved quality of obstetric care regarding deliveries unattended by a provider.

The Report titled Maternal Child Health, dated 11/2018-8/2019, indicated eight deliveries unattended by a provider.

The Surveyor interviewed Registered Nurse #1 at 9:00 A.M. on 9/3/19. Registered Nurse #1 said that physicians were booked in the operating room for gynecologic procedures or were out of the Hospital when a delivery was imminent.

The Surveyor interviewed the Chief of Obstetrics at 12:30 P.M. on 9/3/19. The Chief of Obstetrics said that the Hospital traced the number of nurse deliveries (deliveries without an obstetric Provider present) and that the Hospital identified no trends.