HospitalInspections.org

Based on a review of the clinical record, staff interviews, and a review of hospital documentation for one of three patients (Patient #1), who was a high risk obstetrical patient that required an emergency cesearan section, the hospital's governing body failed to assume full accountability and responsibility for hospital medical practice and conduct.

Refer to A 49

Based on a review of the clinical record, staff interviews, and a review of hospital documentation for one of three patients (Patient #1), who was a high risk obstetrical patient that required an emergency cesarean section, the hospital's governing body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to the patients. The finding included:


1a. Patient #1 was admitted to the hospital on 1/16/18 at 2:43pm with complaints of edema, elevated blood pressure and fetal demise after being evaluated in a physician's office. On arrival, Patient #1's blood pressure was 160/100 and 203/132. Patient #1 had no visual changes, headache, temperature was 98.2 (normal range) and had no epigastric pain on admission. Patient #1 was diagnosed with preeclampsia, intrauterine fetal demise and was a high risk pregnancy. Patient #1 received Hydralazine 10mg (to reduce blood pressure)and Cervidil was placed at 5:23pm.

Review of the clinical record from 1/16/18-1/18/18 identified that Patient #1's blood pressure's intermittently continued to be elevated with blood pressures noted on 1/16/18 at 7:33pm 159/100, 8:50pm 167/101, 630pm 174/106, the patient complained of blurred vision. The goal was to keep blood pressure less than 160/100. Patient #1 was given multiple doses of Hydralazine and Magnesium Sulfate IV was started. Further review identified that the patient was being managed by multiple certified midwives (CSM) from admission through discharge.

On 1/17/18 at 8:30am, Pitocin IV(to induce labor) was started. On 1/17/18 at 12:30pm, the vaginal balloon catheter was inserted (for cervical dilation and ripening). Further review identified that Patient #1's blood pressures continued to be elevated on 1/18/18 at 8:31am 167/101 with complaints of blurred vision and at 1/18/18 at 9:28am 161/103.

Further review identified that on 1/18/18 at 7:56pm, the Pitocin IV was discontinued since the patient was at the maximum dose of 20mg and labor was not progressing. Patient #1's blood pressures continued to be elevated at 8:31am 167/101 with complaints of blurred vision and at 1/18/18 at 9:28am 161/103. On 1/18/18 at 9:10am, the vaginal balloon catheter fell out (19 hours later) after insertion. Further review identified that although the MD #3 was called and made aware of the patient's condition which included an elevated blood pressure and blurred vision, the physician was not in the building managing the high risk patient and/or any OB physician in the hospital.

b. Review of the clinical record identified that on 1/18/18 at 8:25pm, Patient #1 became hypotensive with a blood pressure of 81/48, tachycardia at 110 and a temperature of 103 degrees Fahrenheit. Anesthesia was called in to the room and a fluid bolus was started. The on-call obstetrician (MD #1) was called in and arrived 40 minutes later, MD #1 evaluated the patient and a diagnosis of chorioamnionitis (intra-amniotic infection) was made with a decision to perform an emergency Cesarean Section. Patient #1 delivered a stillborn on 1/18/18 at 9:48pm. Further review failed to identify that the Rapid Response Team was activated (team of providers that respond to hospitalized patients with early signs of deterioration) by the staff when the patient's status had deteriorated in accordance with hospital policy.

Review of the progress note dated 1/19/18 identified that MD #1 was called to the intensive care unit (ICU) by the ICU attending (MD #2) after the patient's blood pressures continued to drop. Blood pressures reported were 83/70, 56/41 and 71/38 with the patient on the maximum dose of four vasopressors (Levophed, Dopamine, Neo-Synephrine and Vasopressin drips) Patient #1 intubated, IV antibiotics and multiple doses of blood products were given. Patient #1 was presumed to be in septic shock and DIC from chorioamnionitis. Further review identified that after a discussion with the family a decision was made to transfer the patient to a higher level of care due to the patient's deteriorating condition. Patient #1 was airlifted to Hospital #2 at 3:55am. On 1/19/18, Patient #1 when into a cardiac arrest at 7:00am and expired at 8:25am. Review of the autopsy report identified the cause of death as severe preeclampsia leading to intrauterine fetal demise, leading to a cesarean section complicated by septic shock with disseminated intravascular coagulation.

Interview with the Chief Nursing Officer on 3/7/18 identified that the hospital had an external consultant review of obstetrical services in 12/2017 identified concerns regarding medical management of high risk pregnancies.

Interview with the Chief Medical Officer on 3/7/18 identified that the physician and not a CNM should of been at the hospital to care for high risk pregnancy patients and that Patient #1 had went too long before having a C-Section. Further interview identified that the hospital was developing a protocol for fetal demise and for the management of the cervical balloon catheter for cervical ripening by the provider. MD #2 indicated that when labor is extended and when the cervical balloon catheter was left in with no staff monitoring the balloon catheter, the risk of infection increased and the Patient #1 became septic.

Interview with the Chief of Obstetrics on 3/7/18 identified that the physician would need to be at the hospital for any high risk patient. Further interview identified that balloon catheter needed to be removed after twelve hours and he/she would have performed the C-Section in the afternoon on 1/18/18 since the patient had no change in progression of labor and was at the maximum dose of pitocin. MD #1 indicated that he/she had developed a new level system recommended from ACOG (American Colleges of Obstetricians and Gynecologist), however had not implemented it yet.

Review of facility policy entitled "Management of Preeclampsia and Eclampsia" identified that the practitioner will be notified within 30 minutes of the arrival of all gravid patients that present to the family birthing center with a blood pressure greater than 140mmHg systolic or greater than 90mmHg diastolic occurring with two readings taken at least 15 minutes apart. In addition, the practitioner will be requested at the bedside for any patient with a blood pressure greater than 160mmHg systolic or greater than 100mmHg diastolic occurring with two readings taken at least 15 minutes apart.

Review of the facility policy entitled "Rapid Response Team" identified that a staff member will consider activating the Rapid Response Team for any of the changes in a patient's condition which includes an acute change in a systolic blood pressure or any changes in the patient's condition if a staff member feels the patient's condition is deteriorating.

Review of facility policy entitled "Cervical Ripening" identified that the balloon catheter may be expelled when cervical dilation occurs, however, the balloon catheter must be removed no longer than 12 hours after insertion.

Review of the Certified Nurse Midwife (CNM) privileges identified that the CNM will manage the care of normal newborns and women, antepartally, intraparatally and postpartally. Further review indicated that the CNM will care for patients of the practice according to agreed upon protocols and in consultation with the physician.

Review of hospital perinatal risk assessment conducted on 12/13-12/14/17 and received on 12/27/17 identified that the obstetrical department had no clear guidelines for on-call providers related to active labor, high risk oversight of Certified Nurse Midwife (CNM) or other elective surgeries. In addition, the assessment indicated that there were no specific written guidelines that outline what conditions for which either the CNM or Family Medicine Specialists need to consult, co-manage or refer to obstetricians. In addition, staff were unclear on the hospital wide use of rapid response process and/or codes. Further review failed to identify that the consultants recommendations to mitigate risk regarding the roles and responsibilities of the medical staff including the medical management of active labor and/or high risk pregnancies were implemented.

Review of the governing body bylaws identified that the operation committee of the governing body will oversee and direct all quality improvement activities of the hospital, including but not limited to assuring that there are ongoing programs to reduce medical errors and provide that all quality improvement activities are evaluated, assure that safety expectations are established, measure and assess the hospital's ongoing performance.

Subsequent to surveyor inquiry on 3/2/18, the facility had submitted an immediate action plan to the state agency. The action plan included re-educating staff on caring for a preeclamptic patient, timely removal of a cervical balloon catheter and when to activate the rapid response team, reviewing of policies and procedures pertaining to family birthing and reviewing the roles and responsibilities of the medical and family birthing staff.

Based on a review of the clinical record, staff interviews, and a review of hospital documentation for one of six patients (Patient #1), who was a high risk obtetrical patient that required an emergency cesearan section, the hospital's Quality Assurance and Performance Improvement (QAPI) program failed to implement interventions subsequent to a perinatal risk assessment dated 12/27/17 to mitigate the risk for patient's who presented with high risk obstetrical conditions to ensure safe qualilty care.

Refer to A 286 and A 309

Based on a review of the clinical record, hospital policies and procedures for one of six sampled patients (Patient #1), who was a high risk obstetrical patient that required an emergency cesearan section, the hospital's Quality Assurance and Performance Improvement (QAPI) failed to implement preventive actions and mechanisms subsequent to a perinatal risk assessment dated 12/27/17 to ensure patient safety. The finding includes:

Review of the clinical record identified Patient #1 was admitted to the hospital on 1/16/18 at 2:43 PM. The patient was thirty eight and one half weeks gestation with severe pre-eclampsia and a known fetal demise. Patient #1 was scheduled for an induction of labor. On arrival to the hospital Patient #1 was afebrile. Initial blood pressures were as follows; 160/100 mmHg and 203/132 mmHg. The clinical record indicated on 1/16/18 Patient #1's blood pressures intermittently continued to be elevated. The patient's blood pressure on 1/16/18 at 6:30 PM was 174/106 mmHg, at 7:33 PM 159/100 mmHg and at 8:50 PM the blood pressure was 167/101 mmHg. Patient #1 intermittently complained of blurred vision, headaches and right upper epigastric pain. The goal was to keep the patients' blood pressure less than 160/100 mm/hg. Hydralazine 10 milligrams (mg) intravenous (IV) was administered on multiple occasions as a treatment modality for hypertension. In addtion, intravenous (IV) Magnesium Sulfate was administered for the prevention of seizures. Pitocin was administered via titration on 1/16/18 and on 1/18/18 for the induction on labor.
On both occasions, the maximum dose of 20 milliunits/minute was achieved absent progression of labor. Cervidil, Cytotex, and a balloon catheter were utilized for assistance with cervical ripening. Further review of the clinical record identified that Patient #1's blood pressures continued to be elevated. On 1/18/18 at 8:31 AM the patient's blood pressure was 167/101 mmHg and at 9:28 AM the blood pressure was 161/103 mmHg. On 1/18/18 at 8:25 PM, Patient #1 became hypotensive with a blood pressure of 81/48 mmHg. The patient's heart rate was 110 beats/minute (normal 60-100 beats/minute) and a temperature of 103 degrees Fahrenheit (Normal temperature 98.6 degrees) was noted. Anesthesia was notified and arrived to the patient's room at 8:31 PM and Ephedrine and a fluid bolus were administered. MD #7 was called into the hospital by the nursing staff at 8:33 PM as the patient was managed by a certified midwife who was assisting another patient. MD #7 was at the bedside of Patient #1 at 9:20 PM (40 minutes later). Further review identified that a diagnosis of chorioamnionitis was made and an emergent Cesarean Section was performed. Patient #2 was delivered stillborn on 1/18/18 at 9:48 PM. Patient #1 remained hypotensive despite the administration of vasopressors. Subsequent to surgery, Patient #1 was transferred to the Intensive Care Unit for further management and was ultimately transferred to an a higher level of care facility on 1/19/18 at 3:55 AM for the treatment of sepsis, disseminated intravascular coagulation (DIC), and hemorrhagic shock. Review of the discharge summary from the transferring hospital identified on 1/19/18 at 7:00 AM the patient went into PEA arrest (Pulseless electrical activity) and cardiopulmonary resuscitation was performed. Patient #1 was pronounced deceased on 1/19/18 at 8:25 AM. Review of the autopsy report identified that the cause of death was severe preeclampsia leading to intrauterine fetal demise, leading to a cesarean section complicated by septic shock with disseminated intravascular coagulation.

Review of hospital perinatal risk assessment conducted on 12/13-12/14/17 and received on 12/27/17 identified that the obsterical department had no clear guidelines for on-call providers related to active labor, high risk oversight of Certified Nurse Midwife (CNM) or other elective surgeries. In addition, the assessment indicated that there were no specific written guidelines that outline what conditions for which either the CNM or Family Medicine Specialists need to consult, co-manage or refer to obstetricians. In addition, the staff were unclear on the hospital wide use of rapid response process and/or codes. Further review failed to identify that the consultants recommendations to mitigate risk regarding the roles and responsibilities of the medical staff including the medical management of active labor and/or high risk pregnancies were implemented.

Interview with the Quality Manager on 3/2/18 at 1:55 PM indicated although a root cause analysis was initiated immediately following the event on 1/18/18, staff interviews had not been conducted, and a comprehensive plan had not been completed.

An immediate action plan was developed on 3/2/18, forty three days following the aforementioned incident on 1/18/18 that included re-educating staff on caring for a preeclamptic patient, timely removal of a cervical balloon catheter and when to activate the rapid response team, reviewing of policies and procedures pertaining to family birthing and reviewing the roles and responsibilities of the medical and family birthing staff.

Based on a review of the clinical record, hospital policies and procedures for one of six sampled patients (Patient #1), who was a high risk obstetrical patient that required an emergency cesearan section, the hospital's Quality Assurance and Performance Improvement (QAPI), failed to ensure the accountability for quality care and patient safety.
The finding included:

Review of the clinical record identified Patient #1 was admitted to the hospital on 1/16/18 at 2:43 PM. The patient was thirty eight and one half weeks gestation with severe pre-eclampsia and a known fetal demise. Patient #1 was scheduled for an induction of labor. On arrival to the hospital Patient #1 was afebrile. Initial blood pressures were as follows; 160/100 mmHg and 203/132 mmHg. The clinical record indicated on 1/16/18 Patient #1's blood pressures intermittently continued to be elevated. The patient's blood pressure on 1/16/18 at 6:30 PM was 174/106 mmHg, at 7:33 PM 159/100 mmHg and at 8:50 PM the blood pressure was 167/101 mmHg. Patient #1 intermittently complained of blurred vision, headaches and right upper epigastric pain. The goal was to keep the patients' blood pressure less than 160/100 mm/hg. Hydralazine 10 milligrams (mg) intravenous (IV) was administered on multiple occasions as a treatment modality for hypertension. Further review identified that intravenous (IV) Magnesium Sulfate was administered for the prevention of seizures and Pitocin was administered via titration on 1/16/18 and on 1/18/18 for the induction on labor. On both occasions the maximum dose of 20 milliunits/minute was achieved absent progression of labor. Cervidil, Cytotex, and a balloon catheter were utilized for assistance with cervical ripening. Further review of the clinical record identified Patient #1's blood pressures continued to be elevated. On 1/18/18 at 8:31 AM, the patient's blood pressure was 167/101 mmHg and at 9:28 AM the blood pressure was 161/103 mmHg. On 1/18/18 at 8:25 PM, Patient #1 became hypotensive with a blood pressure of 81/48 mmHg. The patient's heartrate was 110 beats/minute (normal 60-100 beats/minute), and a temperature of 103 degrees Fahrenheit (normal temperature 98.6 degrees) was noted. Anesthesia was notified and arrived to the patient's room at 8:31 PM with Ephedrine and a fluid bolus were administered. MD #7 was called into the hospital by the nursing staff at 8:33 PM, as the patient was managed by a certified midwife who was assisting another patient. MD #7 was at the bedside of Patient #1 at 9:20 PM. Further review identified that a diagnosis of chorioamnionitis was made and an emergent Cesarean Section was performed. Patient #2 was delivered stillborn on 1/18/18 at 9:48 PM. Patient #1 remained hypotensive despite the administration of vasopressors. Subsequent to surgery, Patient #1 was transferred to the Intensive Care Unit for further management and was ultimately transferred to a higher level of care hospital on 1/19/18 at 3:55 AM for the treatment of sepsis, disseminated intravascular coagulation (DIC) and hemorrhagic shock. Review of the discharge summary from the transferring hospital identified on 1/19/18 at 7:00 AM the patient went into PEA arrest (Pulseless electrical activity) and cardiopulmonary resuscitation was performed. Patient #1 was pronounced deceased on 1/19/18 at 8:25 AM. Review of the autopsy report identified the cause of death as severe preeclampsia leading to intrauterine fetal demise, leading to a cesarean section complicated by septic shock with disseminated intravascular coagulation.

Review of hospital perinatal risk assessment conducted on 12/13-12/14/17 and received on 12/27/17 identified that the obsterical department had no clear guidelines for on-call providers related to active labor, high risk oversight of Certified Nurse Midwife (CNM) or other elective surgeries. In addition, the assessment indicated that there were no specific written guidelines that outline what conditions for which either the CNM or Family Medicine Specialists need to consult, co-manage or refer to obstetricians. In addition, staff were unclear on the hospital wide use of rapid response process and/or codes. Further review failed to identify that the consultants recommendations to mitigate risk regarding the roles and responsibilities of the medical staff including the medical management of active labor and/or high risk pregnancies were implemented.

Interview with the Quality Manager on 3/2/18 at 1:55 PM indicated although a root cause analysis was initiated immediately following the event on 1/18/18, staff interviews had not been conducted, and a comprehensive plan had not been completed.

An immediate action plan was developed on 3/2/18, forty three days following the aforementioned incident on 1/18/18 that included re-educating staff on caring for a preeclamptic patient, timely removal of a cervical balloon catheter and when to activate the rapid response team, reviewing of policies and procedures pertaining to family birthing and reviewing the roles and responsibilities of the medical and family birthing staff.

Immediate Jeopardy (IJ) was identified as evidenced by:

1. The medical staff failed to manage and provide the quality of care to a high risk pregnant patient.

2. The medical staff failed to ensure that a vaginal balloon catheter was removed after twelve hours to reduce the risk of an infection.

3. The hospital failed to timely implement recommendations from the perinatal risk assessment conducted in 12/2017 for patient's that present to to the hospital in active labor and/or high risk pregancy which indicated that the hospital had no clear guidelines for on-call providers related to active labor, high risk oversight of Certified Nurse Midwife (CNM) or other elective surgeries. In addition, the assessment indicated that there were no specific written guidelines that outline what conditions for which either the CNM or Family Medicine Specialists need to consult, co-manage or refer to obstetricians. Also, staff were unclear on the hospital wide use of codes.

4. The medical staff failed to ensure that a Certified Nurse Midwife (CSM) would only provide care for normal newborns and women, antepartally, intraparatally and postpartally.

5. The medical staff failed to activate the Rapid Response Team when the patient's status deteriorated.

See A347

Based on clinical record reviews, review of policies and procedures and interviews with facility personnel for one of six sampled patients (Patient #1), the facility failed to ensure that the medical staff were accountable for the quality of care provided to a obstetrical patient who was determined to be a high risk pregnancy.

The findings include:

1a. Patient #1 was admitted to the hospital on 1/16/18 at 2:43pm with complaints of edema, elevated blood pressure and fetal demise after being evaluated in a physician's office. On arrival, Patient #1's blood pressure was 160/100 and 203/132. Patient #1 had no visual changes, headache, temperature was 98.2 (normal range) and had no epigastric pain on admission. Patient #1 was diagnosed with preeclampsia, intrauterine fetal demise and was a high risk pregnancy. Patient #1 received Hydralazine 10mg (to reduce blood pressure)and Cervidil was placed at 5:23pm.

Review of the clinical record from 1/16/18-1/18/18 identified that Patient #1's blood pressure's intermittently continued to be elevated with blood pressures noted on 1/16/18 at 7:33pm 159/100, 8:50pm 167/101, 630pm 174/106, the patient complained of blurred vision, headaches and right upper epigastric pain. The goal was to keep blood pressure less than 160/100. Patient #1 was given multiple doses of Hydralazine and Magnesium Sulfate IV was started. Further review identified that the patient was being managed by multiple certified midwives (CSM).

On 1/17/18 at 8:30am, Pitocin IV(to induce labor) was started. On 1/17/18 at 12:30pm, the vaginal balloon catheter was inserted (for cervical dilation and ripening). Further review identified that Patient #1's blood pressures continued to be elevated on 1/18/18 at 8:31am 167/101 with complaints of blurred vision and at 1/18/18 at 9:28am 161/103.

Further review identified that on 1/18/18 at 7:56pm, the Pitocin IV was discontinued since the patient was at the maximum dose of 20mg and labor was not progressing. Patient #1's blood pressures continued to be elevated at 8:31am 167/101 with complaints of blurred vision and at 1/18/18 at 9:28am 161/103. On 1/18/18 at 9:10am, the vaginal balloon catheter fell out (19 hours later). Further review identified that although the MD #3 was called and made aware of the patient's condition, the physician was not in the building managing the high risk patient and/or any OB physician in the hospital.

b. Review of the clinical record identified that on 1/18/18 at 8:25pm, Patient #1 became hypotensive with a blood pressure of 81/48, tachycardia at 110 and a temperature of 103 degrees Fahrenheit. Anesthesia was called in to the room and a fluid bolus was started. The on-call obstetrician (MD #1) was called in and arrived 40 minutes later, MD #1 evaluated the patient and a diagnosis of chorioamnionitis (intra-amniotic infection) was made with a decision to perform an emergency Cesarean Section. Patient #1 delivered a stillborn on 1/18/18 at 9:48pm. Further review failed to identify that the Rapid Response Team was activated (team of providers that respond to hospitalized patients with early signs of deterioration) by the staff when the patient's status had deteriorated in accordance with hospital policy.

Review of the progress note dated 1/19/18 identified that MD #1 was called to the intensive care unit (ICU) by the ICU attending (MD #2) after the patient's blood pressures continued to drop. Blood pressures reported were 83/70, 56/41 and 71/38 with the patient on the maximum dose of four vasopressors (Levophed, Dopamine, Neo-Synephrine and Vasopressin drips) Patient #1 intubated, IV antibiotics and multiple doses of blood products were given. Patient #1 was presumed to be in septic shock and DIC from chorioamnionitis. Further review identified that after a discussion with the family a decision was made to transfer the patient to a higher level of care due to the patient's deteriorating condition. Patient #1 was airlifted to Hospital #2 at 3:55am. On 1/19/18, Patient #1 when into a cardiac arrest at 7:00am and expired at 8:25am. Review of the autopsy report identified the cause of death as severe preeclampsia leading to intrauterine fetal demise, leading to a cesarean section complicated by septic shock with disseminated intravascular coagulation.

Interview with the Chief Nursing Officer on 3/7/18 identified that the hospital had an external consultant review of obstetrical services in 12/2017 identified concerns regarding medical management of high risk pregnancies.

Interview with the Chief Medical Officer on 3/7/18 identified that the physician should of been at the hospital to care for high risk pregnancy patients and that Patient #1 had went before having a C-Section. Further interview identified that the hospital was developing a protocol for fetal demise and for the management of the cervical balloon catheter for cervical ripening by the provider. MD #2 indicated that when labor is extended and when the cervical balloon catheter was left in, the risk of infection increased and the Patient #1 became septic.

Interview with the Chief of Obstetrics on 3/7/18 identified that the physician would need to be at the hospital for any high risk patient. Further interview identified that balloon catheter needed to be removed after twelve hours and he/she would have performed the C-Section in the afternoon on 1/18/18 since the patient had no change in progression of labor and was at the maximum dose of pitocin. MD #1 indicated that he/she had developed a new level system recommended from ACOG (American Colleges of Obstetricians and Gynecologist), however had not implemented it yet.

Although the hospital hired an consultant in 12/2017 who reviewed the medical management of high risk pregnancies, the consultant recommended that there was no clear guidelines for on-call providers related to active labor, high risk oversight of Certified Nurse Midwife (CNM) or other elective surgeries. In addition, the assessment indicated that there were no specific written guidelines that outline what conditions for which either the CNM or Family Medicine Specialists need to consult, co-manage or refer to obstetricians. Also, staff were unclear on the hospital wide use of codes. Further review failed to identify that any of the recommendations were implemented to mitigate the risk regarding the medical management of active labor and/or high risk pregnancies.

Review of facility policy entitled "Management of Preeclampsia and Eclampsia" identified that the practitioner will be notified within 30 minutes of the arrival of all gravid patients that present to the family birthing center with a blood pressure greater than 140mmHg systolic or greater than 90mmHg diastolic occurring with two readings taken at least 15 minutes apart. In addition, the practitioner will be requested at the bedside for any patient with a blood pressure greater than 160mmHg systolic or greater than 100mmHg diastoic occuring with two readings taken at least 15 minutes apart.

Review of the facility policy entitled "Rapid Response Team" identified that a staff member will consider activating the Rapid Response Team for any of the changes in a patient's condition which includes an acute change in a systolic blood pressure or any changes in the patient's condition if a staff member feels the patient's condition is deteriorating.

Review of facility policy entitled "Cervical Ripening" identified that the balloon catheter may be expelled when cervical dilation occurs, however, the balloon catheter must be removed no longer than 12 hours after insertion.

Review of the Certified Nurse Midwife (CNM) privileges identified that the CNM will manage the care of normal newborns and women, antepartally, intraparatally and postpartally. Further review indicated that the CNM will care for patients of the practice according to agreed upon protocols and in consultation with the physician.

Review of hospital perinatal risk assessment conducted on 12/13-12/14/17 and received on 12/27/17 identified that the obsterical department had no clear guidelines for on-call providers related to active labor, high risk oversight of Certified Nurse Midwife (CNM) or other elective surgeries. In addition, the assessment indicated that there were no specific written guidelines that outline what conditions for which either the CNM or Family Medicine Specialists need to consult, co-manage or refer to obstetricians. Also, staff were unclear on the hospital wide use of rapid response process and/or codes. Further review failed to identify that the consultants recommendations to mitgate risk regarding the roles and responsibilities of the medical staff including the medical management of active labor and/or high risk pregnancies were implemented.

Subsequent to surveyor inquiry on 3/2/18, the facility had submitted an immediate action plan to the state agency. The action plan included re-educating staff on caring for a preeclamptic patient, timely removal of a cervical balloon catheter and when to activate the rapid response team, reviewing of policies and procedures pertaining to family birthing and reviewing the roles and responsibilities of the medical and family birthing staff.

Based on a review of the clinical record, staff interviews and a review of the hospital's policies and procedures for one of six sampled patients (Patient #1), reviewed for obstetrical care, the hospital failed to consistently document the patients output while Magnesium Sulfate was administered and/or failed to consistently document the patient's oxygen saturation and/or failed to conduct oxygen saturations every thirty minutes in the intrapartum period and/or failed to timely remove a balloon catheter utilized for cervical ripening and/or failed to initiate a rapid response when the patient's condition had deteriorated in accordance with the hospital's policies and procedures.

Please refer to A 395

Based on a review of staffing schedules, review of the staffing plan, review of facility documentation and interviews, the facility failed to ensure that the planned staff to patient ratio was maintained in the ICU (intensive care unit). The finding includes:

Review of ICU staffing, staffing plan, patient acuity and patient for the dates of 2/10/18, 2/11/18 and 2/16/18 through 3/2/18. The ICU patient census and/or staffing at the start of the evening shift on 2/10/18 was 20 patients, 5 RNs, 2 NAs and identified that 1 RN cared for 4 ICU level patients for the greater part of the evening shift. Two patients were newly weaned from ventilators on the day shift, one patient had required a unit of packed red blood cells on the day shift and remained ICU level of care and one patient left AMA (against medical advice) before 7:00PM replaced by a newly admitted patient who required frequent monitoring. Staffing and Census for 2/10/18 into 2/11/18 on the night shift noted a census of 18 patients and NA staffing dropped from 1 to none. The Unsafe Staffing Form dated 2/10/18 and submitted by ICU staff to the Evening Supervisor identified that staff felt that the staffing was not adequate to safely address patient needs with compromises to patient basic hygiene, timely medication administration, and timely patient assessments as required. Review of the email from the evening supervisor dated 2/10/18 indicated that only four nurses were scheduled for the 7:00 PM to 7:00 AM shift, one nurse agreed to stay from 11:00 PM to 3:00 AM and the staffing sheets did not reflect the decrease to 4 nurses for 18 patients after 3:00 AM on 2/11/18. Interview with Nurse Manager #1 on 3/7/18 at 8:12 AM noted that due to nurses leaving, a decrease in ICU nurses and increased patient census in February, the ICU staffing plan could not be met on the evening shift on 2/10/18 and the night shift into 2/11/18. Further interview with the Nurse Manager #1 indicated that the decreased staffing levels were not safe. Interview with the Chief Nursing Officer on 3/8/18 at 2:20 PM indicated that 2/12/17 was the only other reported short staffed day and although calls were made to try to increase staffing on 2/10/18 and 2/11/18, attempts were unsuccessful. The hospital ICU staffing plan identified, in part, that two flex telemetry or intermediate care patient's housed in the ICU unit counted as 1 ICU patient and every effort should be made not exceed a three patient assignment.

Based on medical record reviews, review of facility policies, observations and interviews for 1 of 3 Patients reviewed for pressure ulcers (Patient #7), the facility failed to ensure that assessment of the ulcer was complete and/or that appropriate treatment was provided. The finding includes:

1. Patient #7 was admitted to the ICU (intensive care unit with diagnoses that included right shoulder pain. The initial nursing assessment dated 3/4/18 at 5:49 AM identified a stage II pressure ulcer to the coccyx that measured 1cm (L) by 1cm (W) and depth was left blank. The assessment further identified that the wound edges were macerated and an alginate dressing was applied. Review of the wound assessment dated 3/4/18 at 8:00 AM also documented the coccyx ulcer as 1cm by 1cm (depth left blank) and that an alginate dressing was applied. Review of wound consult sheet by Wound Ostomy Nurse #1 (RN) indicated that the Patient's coccyx ulcer measured 2.5cm by 2.5cm (depth not documented) with red wound base, slough to the upper portion of the ulcer, macerated edges and the treatment was changed to Zinc. Physician orders for wound treatment were not present in the patient's medical record. Observation on 3/6/18 at 10:12 am noted Patient #7 lying on an airflow mattress and positioned slightly to the left side. Interview with Wound Ostomy Nurse #2(RN) on 3/6/18 at 2:47 PM noted that a stage II pressure ulcer does have depth and depth should be assessed/documented. Further interview identified that the alginate dressings were used to absorb drainage and Patient #7's documentation did not reflect ulcer drainage and therefore was not an appropriate dressing/treatment. The hospital policy for wound assessment/management identified that partial thickness broken, cracked or blistered skin was considered a stage II pressure ulcer (some depth). The policy further directed to apply alginate dressings to open wounds with large amount of drainage.


29049

Based on a clinical record review, staff interviews, and a review of hospital documentation for one of six sampled obstetrical patients (Patient #1), the hospital failed to consistently document the patients output while Magnesium Sulfate was administered and/or failed to consistently document the patient's oxygen saturation and/or failed to conduct oxygen saturations every thirty minutes in the intrapartum period and/or failed to timely remove a balloon catheter utilized for cervical ripening and/or failed to initiate a rapid response when the patient's condition had deteriorated in accordance with the hospital's policies and procedures.
The findings included:

2. Review of the clinical record identified Patient #1 was admitted to the hospital on 1/16/18 at 2:43 PM. Patient #1 was thirty eight and one half weeks gestation with severe pre-eclampsia and a known fetal demise. Patient #1 was scheduled for an induction of labor. On arrival to the hospital Patient #1 was afebrile. Initial blood pressures were as follows; 160/100 mmHg and 203/132 mmHg. The clinical record indicated on 1/16/18 Patient #1's blood pressures intermittently continued to be elevated. The patient's blood pressure on 1/16/18 at 6:30 PM was 174/106 mmHg, at 7:33 PM 159/100 mmHg and at 8:50 PM the blood pressure was 167/101 mmHg. Patient #1 intermittently complained of blurred vision, headaches and right upper epigastric pain. The goal was to keep the patients' blood pressure less than 160/100 mm/hg. Hydralazine 10 milligrams (mg) and intravenous (IV) was administered on multiple occasions as a treatment modality for hypertension. Intravenous (IV) Magnesium Sulfate was administered for the prevention of seizures. Pitocin was administered via titration on 1/16/18 and on 1/18/18 for the induction on labor. On both occasions the maximum dose of 20 milliunits/minute was achieved absent progression of labor. Cervidil, Cytotex, and a balloon catheter were utilized for assistance with cervical ripening. Further review of the clinical record identified Patient #1's blood pressures continued to be elevated. On 1/18/18 at 8:31 AM the patient's blood pressure was 167/101 mmHg and at 9:28 AM the blood pressure was 161/103 mmHg. On 1/18/18 at 8:25 PM, Patient #1 became hypotensive with a blood pressure of 81/48 mmHg with a heartrate of 110 beats/minute (normal 60-100 beats/minute), and a temperature of 103 degrees Fahrenheit (normal temperature 98.6 degrees) was noted. Anesthesia was notified and arrived to the patient's room at 8:31 PM with Ephedrine and a fluid bolus being administered. MD #7 was called into the hospital by the nursing staff at 8:33 PM as the patient was managed by a certified midwife who was assisting another patient. MD #7 was at the bedside of Patient #1 at 9:20 PM (40 minutes later). Patient #1 was diagnosised with chorioamnionitis and an emergent Cesarean Section was performed. Patient #2 was delivered stillborn on 1/18/18 at 9:48 PM. Patient #1 remained hypotensive despite the administration of vasopressors. Subsequent to surgery, Patient #1 was transferred to the Intensive Care Unit for further management and was ultimately transferred to an higher level of care hospital on 1/19/18 at 3:55 AM for the treatment of sepsis, disseminated intravascular coagulation (DIC) and hemorrhagic shock. Review of the discharge summary from the transferring hospital identified on 1/19/18 at 7:00 AM the patient went into PEA arrest (Pulseless electrical activity) and cardiopulmonary resuscitation was performed. Patient #1 was pronounced deceased on 1/19/18 at 8:25 AM. Review of the autopsy report identified the cause of death as severe preeclampsia leading to intrauterine fetal demise, leading to a cesarean section complicated by septic shock with disseminated intravascular coagulation.


a. Review of the physician's orders identified on 1/16/18 at 6:20 PM Magnesium Sulfate 20 grams/500 ml was ordered for seizure prophylaxis with a loading dose of 4 grams and a maintenance dose of 2 grams/hour. Review of the intake and output shift record identified from 1/16/18 at 6:20 PM through 1/18/18 at 8:30 PM the urine output failed to be documented on three occasions. Interview with Nurse Manager #2 on 3/2/18 at 1:00 PM indicated hourly urine output should have been documented and was not. The hospital policy entitled Management of Pre-eclampsia and Eclampsia directed in part, that when a patient was administered Magnesium Sulfate, the patient's output would be documented hourly.

b. Interview and review of the obstetrical pre-eclampsia assessment sheets with Nurse Manager #2 on 3/2/178 at 1:10 PM identified from 1/16/18 at 6:20 PM through 1/18/18 at 9:12 AM when the patient was in the antepartum period, oxygen saturations failed to be documented on seventeen occasions. Review of the hospital policy entitled Management of Pre-eclampsia and Eclampsia, directed in part, that when a patient was administered Magnesium Sulfate, oxygen saturations would be documented hourly in the antepartum period.

c. Interview with Nurse Manager #2 on 3/2/18 at 1:20 PM indicated the intrapartum period began for Patient #1 on 1/18/18 at 9:12 AM and commencing at that time oxygen saturations should have been conducted every thirty minutes and were not. Review of the obstetrical pre-eclampsia assessment sheets with Nurse Manager #2 identified from 1/18/18 at 9:12 AM through 1/18/18 at 8:30 PM, oxygen saturations failed to be conducted every thirty minutes on eleven occasions. Review of the hospital policy entitled Management of Pre-eclampsia and Eclampsia directed in part oxygen saturations would be documented every thirty minutes in the intrapartum period.

d. Review of the clinical record identified that a balloon catheter was inserted intravaginal on 1/17/18 at 1:23 PM and spontaneously evacuated on 1/18/18 at 9:10 AM, over nineteen hours later. Interview with the Chief of Obstetrics on 3/2/18 at 2:30 PM indicated the balloon catheter should have been removed within twelve hours due to the risk of infection. Interview with Nurse Manager #2 on 3/2/18 at 1:30 PM identified the nurses failed to have a mechanism in place to ensure the balloon catheter would be removed within twelve hours. Review of the hospital policy entitled cervical ripening failed to identify when the balloon catheter should be removed. Subsequent to the investigation, the cervical ripening policy directed the balloon catheter must be removed twelve hours or less after insertion.

e. Interview with Nurse Manager #2 on 3/2/18 at 1:40 PM indicated the nursing staff failed to activate the Rapid Response Team when the patient's condition was deteriorating on 1/18/18 at 8:25 PM. The hospital policy entitled Rapid Response Team directed the purpose of a rapid response was to prevent cardiopulmonary arrest in patients showing signs of deterioration through prompt assessment, intervention and stabilization of the patient. The team would be comprised of an intensive care nurse, a hospitalist, and a respiratory therapist. The team would include at least one member that has successfully completed training in Advanced Cardiac Life Support. The rapid response team was to assess the situation and make recommendations for the treatment and stabilization of the patient. The policy further directed that a rapid response may be activated by any staff member for any changes in the patient condition, it the staff member feels the patient's condition is deteriorating.

Further interview with Nurse Manager #2 on 3/2/18 at 1:50 PM indicated after the event on 1/18/18 a debriefing occurred and discussion regarding the activation of a rapid response was communicated however, this discussion was not documented or provided to the entire family birthing staff members.

Interview with the Quality Manager on 3/2/18 at 1:55 PM indicated although a root cause analysis was initiated immediately following the event on 1/18/18, staff interviews had not been conducted, and a comprehensive plan had not been completed.

Subsequent to the surveyor's inquiry an immediate action plan was developed on 3/2/18 that included re-education of the family birthing center (FBC) staff regarding the care delivered in the antepartum, intrapartum, and postpartum phase of the pre-eclamptic patient. The education included a review of policies entitled; Management of Pre-eclampsia and Eclampsia, Management of Acute Hypertensive Crisis in Pregnancy, the Rapid Response Team, and a review of the high reliability organization principle of following the chain of command if needed. In addition the policy for Cervical Ripening was reviewed and revised to ensure documentation of the time when the balloon catheter was inserted, and the time of removal.