The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

COOLEY DICKINSON HOSPITAL INC,THE 30 LOCUST STREET NORTHAMPTON, MA 01060 Feb. 4, 2014
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
Based on interview, the Hospital failed to ensure that nurses providing surgical care to cesarean section patients in the Child Birth Center operating room, were educated in advanced cardiac life support (ACLS) consistent with the Hospital requirement that surgical service nursing staff are ACLS trained.

Findings include:

According to Taber's Encyclopedic Medical Dictionary, Edition 20, a cesarean section is a surgical procedure for removal of the fetus, placenta and membranes through an incision in the abdominal and uterine walls.

The NM said that the nurses who provide perioperative nursing care, (care of patients immediately before, during and right after surgery), to cesarean section patients in the Child Birth Center operating room (Labor and Delivery rooms), are not required to have Advanced Cardiac Life Support (ACLS) training, even though ACLS is a Hospital requirement for nurses who work in perioperative nursing areas.

The NM said Labor and Delivery nursing staff are only trained in cardiac dysrhythmia (irregular heart beat) recognition where as nurses in the main operating room all are ACLS trained.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on record reviews for 3 of 12 sampled patients (Patients (Pts). #1, #2, #3), interviews and review of Hospital policies titled Chain of Command in Resolving Conflicts, Fetal Monitoring and Code Cart Management, the Governing Body (GB) failed to be responsible for the conduct of the Child Birth Center.

Findings include:

1.) The Governing Body failed to ensure that the Medical Staff was accountable for the quality of care provided to 3 of 12 sampled patients (Patients #1, #2 and #3). The failure to provide quality medical care resulted in the death of all three patients.

2.) The GB failed to ensure that the transfer agreement to Hospital B which had the next highest level of maternal services was effective and efficient, for one patient (Patient #1), in a total sample of 12, whose condition required the services. The Child Birth Center (CBC) attempted to transfer Patient #1 to Hospital B, located 18 miles from the Hospital, but systems issues did not allow the transfer and Patient #1 was transferred to another to another maternal care hospital with the same services, by helicopter, located approximately 118 miles away where the patient died .

See A-083.

3.) The GB failed to ensure patients were cared for in a safe setting by ensuring 3 of 12 patients (#1, #2 and #3) recieved appropriate care and treatment in timely manner.

See A-0115

4.) The GB failed to ensure a well-organized nursing service by failing to ensure the polices for Fetal Monitoring and Chain of Command in Resolving Conflicts were implemented during the care of Patients #1 and #3 which contributed to the deaths of Patients #1 and #3.

See A-0385.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on record review of 3 of 12 sampled patients (Pts. #1, #2 and #3), interviews and policy review, the Governing Body (GB) failed to ensure that the medical staff was accountable for the quality of care provided to patients. The failure to provide quality medical care resulted in the death of all three patients.

Findings include:

1.) Review of Nurses Notes, dated 10/28/13 at 10:20 A.M., indicated that Patient #1 called Obstetrician (OB) #1 at 3:00 A.M., with complaints of epigastric pain and vomiting. Nurse notes indicated Patient #1 became increasingly confused on the ride to the Hospital.

The Surveyor interviewed RN #3 on 2/4/14 at 10:30 A.M. RN #3 said that within 10 minutes of Patient #1's presentation to the Child Birth Center (CBC), Patient #1 had a blood pressure of 179/144 (normal 90-120/ 60-80) and was clammy, combative and incoherent.

Nurses Notes, dated 10/28/13, at 8:17 A.M., indicated Patient #1 had a blood pressure of 190/136 (normal 90-120/ 60-80).

Patient #1 was intubated and taken to the operating room on the labor and delivery unit for delivery of the baby via cesarean section. The patient received Magnesium Sulfate (treats seizures) for presumed pre-eclampsia ( a life threatening complication of the last few months of pregnancy, with symptoms of headache, swelling of the feet, dizziness, sudden weight gain, nausea, vomiting, abdominal pain. Late symptoms include changes in mental status and seizures) but did not receive treatment for her high blood pressure.

Patient #1 remained unconscious after delivery of the baby and was transferred to the Intensive Care Unit (ICU). Once stabilized, a CAT ( computerized axial tomography) scan was done of the head which revealed a massive cerebral hemorrhage (stroke). Patient #1 was transferred via helicopter to Hospital C, where she died .

2.) Review of Certified Nurse Midwife (CNM) #3's Note, dated 12/13/13 at 8:08 A.M. indicated that mother of Patient #2 had a prominent sacrum (variation in pelvic anatomy). The medical record did not indicate the significance of, or communication to other providers, about the prominent maternal sacrum, or if any special management during delivery was needed related to the prominent sacrum.

A Physician Note, dated 12/13/13 at 5:50 P.M., indicated that Patient #2's neck was wedged behind the mother's pubic bone and the mother's sacrum (tailbone).

Patient #2 was stuck in the birth canal and unable to be removed by cesarean section delivery and died .

The Surveyor interviewed the Risk Manager on 2/3/14 at 11:30 A.M. The Risk Manager said she asked during the hospital internal investigation if the prominent sacrum was enough reason to perform the Cesarean Section earlier and she did not receive an answer to the question.



3.) Record review indicated that after being questioned by a Registered Nurse (RN) about whose heart beat the fetal monitor was recording, a Certified Nurse Midwife (CNM) decided the heart beat recording was that of Patient #3, the baby. Patient #3 was delivered on 1/20/2014, without a heart beat and neonatal resuscitation was unsuccessful.

Labor & Delivery (L&D) notes, dated 1/20/14 at 12:59 P.M. indicated a fetal heart rate (FHR) and a Sinusoidal rhythm (abnormal heartbeat pattern indicating increased risk for death for the baby) for 10 minutes in the last 30 minutes of fetal monitoring. The L&D Notes did not indicate an explanation, evaluation or interventions for the sinusoidal pattern, by either the RN or the CNM.

The L&D Notes, written by CNM #1, on 1/20/14 at 12:30 P.M., did not indicate what the EFM (electronic fetal monitor) pattern was and CNM #1's last note at 4:30 P.M., did not indicate what the EFM pattern was and Patient #3 was delivered at 7:27 P.M., without a heartbeat and was unable to be resuscitated.

4.) The Surveyor interviewed the Chair of the Board of Trustees (CBT) on 2/3/14 at 11:00 A.M. The CBT said that the Board is intensively focused on the events happening in the CBC although he did not articulate an active plan to manage, fund and implement a corrective action plan.

5.) The Surveyor interviewed the Interim Associate Chief Medical Officer (A-CMO) on 2/3/14. The A-CMO said that the CBC had poor communication among its providers that lead to poor quality of care outcomes.


Electronic mail (e-mail) dated 2/26/14, indicated that the A-CMO was not a member of the Governing Board (GB, Board of Trustees), although he did occasionally attend the GB meetings and that the Chief Medical Officer (CM) was a non-voting member of the GB.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on record review and interview for one sampled patient (Patient #1) in a total sample of 12, whose condition required the services of a Level III perinatal services (highest level of care for maternity care), the GB failed to ensure that the transfer agreement for Level III perinatal services at contracted Hospital B, was effective and efficient.

Findings include:

1.) The Child Birth Center (CBC) attempted to transfer Patient #1 to Hospital B, located 18 miles from the Hospital, but systems issues did not allow the transfer and Patient #1 was transferred to another Level III perinatal center by helicopter, located approximately 118 miles away where the patient died .

2.) Patient #1's mental status, vital signs and clinical condition quickly deteriorated upon presentation to the Hospital and Obstetrician (OB) #1, an attending Obstetrician at the Hospital, evaluated Patient #1's clinical condition as critical and life-threatening, which required transfer to the closest hospital with higher level of maternity care, Hospital B. Hospital B was approximately 18 miles from the Hospital.

3.) The Surveyor interviewed OB #1 on 2/3/14 at 4:00 P.M. OB #1 said she spoke with a resident physician at Hospital B about transferring Patient #1 and the Resident Physician at Hospital B would not talk to her until Patient #1's vital signs were stable. The Resident Physician said that an attending physician would call her back. OB #1 said that Hospital B was not available for attending Obstetric consultation regarding Patient #1's critical condition. OB #1 said that the system at Hospital B was not easy to navigate and it was not easy to get through the layers of the system. OB #1 said that the Obstetric Department and Hospital administrators were aware of the barriers with communications with Hospital B.

4.) The Surveyor interviewed OB #2 on 2/4/14 at 12:30 P.M. OB #2 said that communications with Hospital B were difficult and the process for initiating a transfer was long.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, record review of 3 of 12 sampled patients (Pts. #1, #2 and #3), interviews and review of the Hospital's policies titled, Fetal Monitoring, Chain of Command in Resolving Conflicts and Code Cart Management, the Hospital failed to protect and promote patients rights.

Findings include;

1.) The Hospital failed to ensure patients were cared for in a safe setting by ensuring patients received appropriate care and treatment in timely manner. For example:

2.) The Hospital failed to ensure that Patient #1 was treated for hypertension, headache, epigastric pain and altered level of consciousness in pregnancy, according to current standards of Obstetric care. Patient #1 suffered a cerebral vascular accident (stroke) and died at another hospital, shortly after transfer.

3.) The Hospital failed to ensure that Patient #2's mother's variation in pelvic anatomy was communicated, early in the labor process. This lead to a prolonged pushing phase that resulted in Patient #2's head being wedged in the maternal pelvis. After the mother was to fatigued to push, a cesarean section was done but Patient #2 was too tightly wedged in the pelvis and died during attempts to extricate Patient #2 from the womb.

4.) The Hospital failed to ensure that Patient #3 was monitored according to the Hospital's policy titled, Fetal Monitoring and Patient #3's heart rate/rhythm concerns were communicated according to the Hospital's policy titled, Chain of Command in Resolving Conflicts. The fetal heart monitoring pattern prior to Patient #3's delivery was not normal and the Certified Nurse Midwife (CNM) did not listen to the Registered Nurse #1's concerns about the abnormal heart rhythm on the fetal monitor. Patient #3 was delivered without a heartbeat and could not be resuscitated.

5.) Emergency carts on the Child Birth Center (CBC) were not checked daily, according to the Hospital's, Code Cart Management, policy.

See A-0144.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review of 3 of 12 sampled patients (Pts. #1, #2, #3), interview and review of the Hospital's policies titled, Electronic Fetal Monitoring (EFM), Chain of Command in Resolving Conflicts and Code Cart Management, the Hospital failed to ensure patients were cared for in a safe setting.

Findings include:

1.) The Hospital failed to ensure that Patient #1 was treated for signs and symptoms of [DIAGNOSES REDACTED].

The American College of Obstetricians and Gynecologists (ACOG) article titled, Emergent Therapy for Acute-Onset, Severe Hypertension (high Blood pressure (BP)) with Preeclampsia or[DIAGNOSES REDACTED], (a life threatening complication of the last few months of pregnancy, with symptoms of [DIAGNOSES REDACTED]#514, dated (December 2011), indicated that acute-onset, persistent (lasting 15 minutes or more), severe systolic (greater than or equal to 160 mm Hg) or severe diastolic high BP (greater than or equal to 110 mm Hg) or both in pregnant or postpartum women with preeclampsia or[DIAGNOSES REDACTED] constitutes a hypertensive emergency. Severe systolic high BP may be the most important predictor of cerebral hemorrhage and infarction in these patients and if not treated expeditiously can result in maternal death. Intravenous Labetalol and Hydrazaline (blood pressure medications) are both considered first-line drugs for the management of acute, severe high BP in this clinical setting.

Review of Patient #1's medical record did not indicate medication and/or treatments were administered to Patient #1, for severe hypertension (high BP), until two hours after her arrival to the Hospital. Patient #1 received Magnesium Sulfate for presumed preeclampsia in the operating room during the cesarean section delivery of the baby. Patient #1 was intubated prior to the cesarean section, never regained consciousness and was transferred to Hospital C where she died of a massive cerebral hemorrhage (stroke).

2.) The Hospital failed to ensure that Certified Nurse Midwife (CNM) #3 communicated that Patient #2's mother had a variation in pelvic anatomy (prominent sacrum (tailbone)).

Review of Certified Nurse Midwife #3's Note, dated 12/13/13 at 8:08 A.M., indicated that Patient #2's mother had a prominent sacrum. The medical record did not indicate the significance of the prominent maternal sacrum, or if management during delivery was needed related to the prominent sacrum.

A Physician Note, dated 12/13/13 at 5:50 P.M., indicated that Patient #2's head was wedged behind the pubic bone and the mother's tailbone was wedged into Patient's #2 neck.

The Surveyor interviewed the Risk Manager on 2/3/14 at 11:30 A.M. The Risk Manager said she asked during the hospital internal investigation if the prominent sacrum was an indication for an earlier Cesarean Section and she did not receive an answer to the question.


After the mother pushed for three hours. Patient #2 was unable to be unwedged from the mother's pelvis. Patient #2 died in the mother's womb.


3.) The Hospital failed to ensure that Patient #3 was monitored according to the Hospital's policy titled Fetal Monitoring and that Patient #3's heart rate/rhythm concerns were communicated according to the Hospital's policy titled Chain of Command in Resolving Conflicts.

The Hospital policy titled, Fetal Monitoring, dated 5/2013, indicated that the baby's heartbeat pattern and the mother's uterine activity will be documented every 30 minutes - 60 minutes during the first (early to active) stage of labor and every 15 minutes during the second (pushing) stage of labor.

Review of the Labor and Delivery (L&D) Notes, written by CNM #1, on 1/20/14, indicated Patient #3's heart beat pattern and the mother's uterine activity was not documented, every 30 minutes to 60 minutes during the first stage of labor and or every 15 minutes during the second stage of labor, in accordance with the Hospital policy titled, Fetal Monitoring.

The policy titled, Chain of Command in Resolving Conflicts, dated 11/09, indicated that staff should activate the chain of command to resolve any conflicts when initial actions are unsuccessful.

The Surveyor interviewed RN #1, on 2/3/14 at 4:30 P.M. RN #1 said that she told CNM #1, that Patient #3's heart rate was at 100 beats per minute (BPM), then 80 BPM, then 60 BPM, then she could not obtain the baby's heartbeat. The baby was then delivered without a heartbeat. RN #1 said that the fetal monitor was recording the baby's heartbeat in a "W" pattern (abnormal) and that she was not comfortable with the situation. RN #1 said that CNM #1 restarted the Pitocin then increased the Pitocin and she (RN #1) did not like this decision. RN #1 said that the Charge Nurse asked if they were sure they were recording the baby's heartbeat. RN #1 said she told Obstetrician (OB) #2, specifically, about the fetal heart pattern and expected him to come and assess the situation in the room but he did not. RN #1 said that she wished someone had taken her concerns more seriously.

RN #1 said she did not consult with the Charge Nurse or an Obstetrician regarding her concerns until delivery of the baby was imminent which was approximately 15 minutes prior to the delivery. This was not consistent with the Hospital's policy titled Chain of Command in Resolving Conflicts.

The Surveyor interviewed the Risk Manager on 1/31/13 at 11:45 A.M. The Risk Manager said that the Hospital Internal Investigation indicated that RN #1 did not communicate according to the Hospital's Chain of Command policy.

4.) Emergency carts on the Child Birth Center (CBC) were not checked daily, according to the Hospital's, Code Cart Management policy.

The Surveyor observed during a tour of the CBC on 1/31/14 that the checklists were incomplete for the Emergency Neonatal Cart in the Nursery and the Emergency Neonatal and Adult Carts on the Labor & Delivery unit. The Labor & Delivery, Neonatal Emergency Carts were missing checks for 8 days in 1/13. The Nursery, Neonatal Emergency Code Cart was missing checks for 8 days in 1/13. The Adult Emergency Cart was missing checks for 11 days in 1/13.

Failure to check the Code Carts daily, as per policy, could lead to staff not having the necessary emergency equipment, supplies and medications for patients requiring emergency treatments.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on review of the Hospital's internal investigation of maternal and fetal deaths and interview, the Hospital Internal Investigation (HII) failed to identify opportunities for improvement when Obstetric providers identified they had difficulty obtaining either appropriate medical consultation and/or effective and efficient transfer arrangements, regarding one critically ill sampled patient (Patient #1), in a sample of 12, and that Obstetricians complained of work fatigue.

Findings include:

1.) The Surveyor interviewed Obstetrician (OB) #1 on 2/3/14 at 4:00 P.M. and OB #2 on 2/4/14 at 12:30 P.M., OB #1 and #2 said that it was difficult to communicate with and navigate through the layers of the system at Hospital B. OB #1 said she had difficulty when trying to get a transfer arranged for Patient #1 with Hospital B. OB #1 said that Hospital B, is a contracted referral hospital which has the highest level of perinatal care closest to the Hospital.

The Surveyor interviewed the Chief of Medicine/Chair of the Medical Staff (Physician #1), on 2/4/14 at 1:00 P.M. Physician #1 said that communications with Hospital B were difficult, Hospital administration was aware of the difficulties and as the Chair of the Medical Staff Quality Improvement Committee (MSQIC), she would expect communication follow-up from Hospital administration.

The Surveyor interviewed the Obstetric Department Chair on 2/4/14 at 11:00 A.M. The OB Department Chair said that the relationship with Hospital B was good, the transfer process was fine, there were no barriers and Patient #1 needed to be stabilized prior to transport.

2.) The HII failed to identify Obstetrician work fatigue.

The Surveyor interviewed the Obstetrician Expert Consultant (OBEC) on 2/3/14 at 1:00 P.M. The OBEC said that the Obstetric staff was short staffed and he did not know how they could not have work fatigue.

The Surveyor interviewed OB #2 on 2/4/14, at 12:30 P.M. OB #2 said that he was tired from every other night physician call coverage.

The Surveyor interviewed the Obstetric (OB) Department Chair on 2/4/14 at 11:00 A.M. The OB Department Chair said that it has been a hard 3 months due to staffing shortages and maternal and neonatal deaths.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on record review for 3 of 12 sampled patients (Pts. #1, #2 and #3), interviews and review of Hospital policies titled, Chain of Command in Resolving Conflicts and Fetal Monitoring, the Hospital failed to ensure that the Medical Staff was responsible for the quality of medical care provided to 3 patients cared for in their Child Birth Center (CBC, maternity unit) that resulted in 1 maternal & 2 newborn deaths.

Findings include:

1.) Physicians failed to treat and manage Patient #1's hypertensive (high blood pressure) crisis for two hours after she arrived at the Child Birth Center (CBC). Patient #1 was transferred to Hospital C, where she died of a massive cerebral vascular accident (stroke).

2.) The Medical Staff failed to ensure that Patient #2's mother's variation in pelvic anatomy was communicated, early in the labor process. This lead to a prolonged pushing phase that resulted in Patient #2's head being wedged in the maternal pelvis. After the mother was to fatigued to push, a cesarean section was done but Patient #2 was too tightly wedged in the pelvis and died during attempts to remove Patient #2 from the mother's womb.

3.) The Medical Staff failed to ensure that Patient #3 was monitored according to the Hospital's policy titled, Fetal Monitoring and Patient #3's heart rate/rhythm concerns were communicated according to the Hospital's policy titled, Chain of Command in Resolving Conflicts. Patient #3's fetal heart monitoring pattern prior to delivery was not normal. The Certified Nurse Midwife did not listen to Registered Nurse #1's concerns about the abnormal heart patterns on the fetal monitor. Patient #3 was delivered without a heart beat and could not be resuscitated.

4.) The Medical Staff failed to have an efficient system of internal and external peer-review for the Obstetric care. The medical staff also failed to ensure all members of the Obstetric staff, including the CNMs had an understanding of the peer review process.

5.) The Medical Staff failed to assure an adequate number of Obstetric providers to meet the needs of the patients and minimize Obstetrician work fatigue.

See A-0347
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review for 3 of 12 sampled patients (Pts. #1, #2 and #3), interviews and review of the Hospital's policies titled, Chain of Command in Resolving Conflicts and Fetal Monitoring, the Medical Staff (1) failed to provide quality medical care; (2) failed to have an efficient system of internal and external peer review for Obstetric care and (3) failed to identify and resolve Obstetric providers' work fatigue. The failure to provide quality medical care resulted in the death of all three patients

Findings include:

1.) Physicians failed to treat Patient #1's high blood pressure (BP), headache, epigastric pain and altered level of consciousness, according to current standards of Obstetric practice.

The American College of Obstetricians and Gynecologists (ACOG) article titled, Emergent Therapy for Acute-Onset, Severe Hypertension (high BP) with Preeclampsia or[DIAGNOSES REDACTED] (a life threatening complication of the last months of pregnancy, with symptoms of [DIAGNOSES REDACTED]#514, dated (December 2011), indicated that acute-onset, persistent (lasting 15 minutes or more), severe systolic (greater than or equal to 160 mmHg) or severe diastolic high BP (greater than or equal to 110 mmHg) or both in pregnant or postpartum women with preeclampsia or[DIAGNOSES REDACTED] (a life threatening complication of the last months of pregnancy, with symptoms of [DIAGNOSES REDACTED]. Intravenous Labetalol and Hydrazaline (BP medications) are both considered first-line drugs for the management of acute, severe hypertension (high BP) in this clinical setting.

Review of Nurses Notes, dated 10/28/13 at 10:20 A.M., indicated that Patient #1 called Obstetrician (OB) #1 at 3:00 A.M., with complaints of epigastric pain and vomiting. Nurse notes indicated Patient #1 became increasingly confused on the ride to the Hospital.

The Surveyor interviewed RN #3 on 2/4/14 at 10:30 A.M. RN #3 said that within 10 minutes of Patient #1's presentation to the Child Birth Center (CBC), Patient #1 had a BP of 179/144 (normal BP is 90 - 130 systolic over 60 - 80 diasystolic) and was clammy, combative and incoherent.

Nurses Notes, dated 10/28/13 at 8:17 A.M. indicated Patient #1 had blood pressure of 190/136.

Patient #1 was intubated and taken to the operating room on the labor and delivery unit for delivery of the baby via cesarean section. The patient received Magnesium Sulfate (treats seizures) for presumed pre-eclampsia but did not receive treatment for her high blood pressure.

Patient #1 remained unconscious after delivery of the baby and was transferred to the Intensive Care Unit (ICU). Once stabilized, a CAT (computerized axial tomography) scan was done of her head which revealed a massive cerebral hemorrhage (stroke). Patient #1 was transferred via helicopter to Hospital C, where she died .

The Surveyor interviewed OB #1 on 2/3/14 at 4:00 P.M. OB #1 said she thought Patient #1 had ingested something, because Patient #1 did not have seizures which usually go along with preeclampsia.

OB#1 said she had never seen this presentation before of Patient #1's presumed diagnosis of [DIAGNOSES REDACTED]" for hemolysis (breakage of red blood cells), "EL" for elevated liver enzymes, and "LP" for low platelet count (an essential blood clotting element)]; a life-threatening obstetric complication of preeclampsia.

The Surveyor interviewed the Obstetrician Expert Consultant (OBEC) on 2/3/14 at 1:00 P.M. The OBEC said that there was a gap in policies and procedures and that the Obstetric service did not have a policy and procedure on the management of hypertensive (high blood pressure) disorders in pregnancy or an accompanying provider order set (doctors orders).

2.) The Hospital failed to ensure that Certified Nurse Midwife (CNM) #3 communicated that Patient #2's mother had a variation in pelvic anatomy (prominent sacrum).

Review of Certified Nurse Midwife #3's Note, dated 12/13/13 at 8:08 A.M., indicated that Patient #2's mother had a prominent sacrum (tailbone). The medical record did not indicate the significance of the prominent maternal sacrum, or if any special management during delivery was needed related to the prominent sacrum.

A Physician Note, dated 12/13/13 at 5:50 P.M., indicated that Patient #2's head was wedged behind the pubic bone and the mother's sacrum (tailbone) was wedged into Patient's #2 cervical spine.

Medical record review of maternal assessments, done by CNM #2 and interview with CNM #2, on 2/3/14 at 2:50 P.M., indicated that CNM #2 was not aware of the significance of the prominent sacrum (tailbone) as documented by CNM #3 and the potential delivery complications it may have had for the Patient #2. CNM #2 was the midwife who assisted the mother during the labor and up until the decision was made that the mother could not deliver Patient #2 by vaginal birth.

The Surveyor interviewed OB #1 on 2/3/14 at 4:00 P.M., OB #1 said the Patient #2 was stuck in the mother's birth canal and could not be successfully delivered by cesarean section. The baby (Patient #2) died in the mother's womb.

The Surveyor interviewed the Risk Manager on 2/3/14 at 11:30 A.M. The Risk Manager said she asked if the prominent sacrum was enough reason to perform the cesarean section earlier and she did not receive an answer to the question.

3.) For Patient #3, the Certified Nurse Midwife (CNM) #1 failed to monitor and document Patient #3's heart beat according to the Hospital's Fetal Monitoring policy.

The Hospital policy titled, Fetal Monitoring, dated 5/2013, indicated that the baby's heartbeat pattern and the mother's uterine activity will be documented every 30 minutes to 60 minutes during the first (early to active) stage of labor and every 15 minutes during the second (pushing) stage of labor.

CNM #1 failed to listen to RN #1 said who questioned whether the electronic fetal monitor (EFM) was monitoring, the baby (Patient #3) or the mother.

CNM #1 failed to consult with a supervising Obstetrician (OB) when RN #1 questioned who the EFM was monitoring, the baby (Patient #3) or the mother.

OB #2 failed to communicate directly with CNM #1 when he (OB #2), the Charge Nurse (RN #2) and RN #1 questioned who the EFM was monitoring, the baby (Patient #3) or the mother.

Review of Labor & Delivery (L&D) notes, dated 1/20/14 at 12:59 P.M. indicated a fetal heart rhythm (FHR) of sinusoidal (abnormal heartbeat pattern indicating increased risk for fetal death) pattern of 10 minutes in the last 30 minutes of fetal monitoring. The L&D Notes did not indicate an explanation, evaluation or interventions for the sinusoidal heartbeat pattern, by either the RN #1 or the CNM #1.

Review of the L&D Notes, written by CNM #1, on 1/20/14 at 12:30 P.M., did not indicate the EFM pattern, and CNM #1 last note at 4:30 P.M., did not indicate the EFM pattern. Patient #3 was delivered at 7:27 P.M. The L&D Notes did not indicate a summary of the FHR pattern and uterine activity was documented by CNM #1 every hour, according to the Hospital policy titled, Fetal Monitoring. The L&D Notes, written by CNM #1, failed to address abnormal heart rhythms documented by the RNs such as 13 episodes of decreases in Patient 3's heartbeat, 10 episodes where the heartbeat did not increase, 2 episodes where the heartbeat did not show variability (strength to increase or decrease) and 10 episodes where Patient #3's heartbeat did not accelerate or decelerate.

Review of the L&D Notes, dated 1/20/14 at 6:35 P.M. and documented by RN #1, indicated CNM #1 asked "is that the baby?" and RN #1 stated the baby's heartbeat was about 100 (low range of normal) beats per minute (BPM) and the maternal heartbeat was about 120 BPM (normal adult heart beat for a laboring mother). RN #1 stated "the baby was making "W's " (abnormal life threatening heart beat pattern, on the heart monitor). The actual rhythm was a "U" shaped rhythm but the RN described the rhythm incorrectly as a "W." The rhythm was abnormal and potentially lethal for Patient #3 and the L&D Notes did not indicate an evaluation by CNM #1 of RN #1's assessment for Patient #3.

Review of the L&D Notes, dated 1/20/14 at 6:50 P.M., and documented by RN #1, indicated that the Charge Nurse (RN #2) asked if RN #1 was sure the baby was monitored and RN #1 said "no, I'm trying."

Review of the L&D Notes, dated 1/20/14 at 6:54 P.M., and documented by RN #1, indicated that the baby's heartbeat was about 60 BPM (abnormally low), the maternal heartbeat was 120 BPM and the CNM said "no, this is baby."

The Surveyor interviewed CNM #1 on 2/4/14 at 9:30 A.M. CNM #1 said she was confident that she was monitoring Patient #3's heartbeat during the labor process. CNM #1 said she was devastated when Patient #3 was born without a heartbeat and could not be resuscitated.

The Surveyor interviewed OB #2 on 2/4/14 at 12:30 P.M. OB #2 said he assessed the fetal monitor (EFM) for Patient #3 and questioned if the recording was the maternal heartbeat and told the Charge Nurse (RN #2) to evaluate the situation with CNM #1. OB #2 said he requested the Charge Nurse to evaluate the situation first because the delivery was imminent.

The Surveyor interviewed RN #1 on 2/3/14 at 4:30 P.M. RN #1 said that she told CNM #1, during the course of the Patient #3's mother's labor, that she assessed the baby's heart rate at 100 beats per minute ((BPM), normal can be 110 to 160 BPM)), then 80 BPM, then 60 BPM (according to neonatal resuscitation standards, neonatal resuscitation should commence at 60 BPM), then could not obtain Patient #3's heartbeat and the patient was delivered without a heartbeat. RN #1 said that the EFM was recording the baby's heartbeat in a "W" pattern (sinusoidal or "U" pattern) and she was concerned with the situation. RN #1 said that CNM #1 restarted the Pitocin (labor medication) because maternal contractions were not strong and she (RN #1) did not like this decision. RN #1 said at one point the Charge Nurse (RN #2) entered the room and asked if they were sure they were recording Patient #3's heartbeat. RN #1 said she told OB #2, specifically, that she was concerned and had expected him to come to the room. She said she should have requested OB #2 assess the situation in the room. RN #1 said that she wished someone had taken her concerns more seriously.

Patient #3 was dead at birth, unable to be resuscitated.

4.) The Hospital failed to have an efficient system of internal and external peer review for Obstetric care. The medical staff also failed to ensure all members of the Obstetric staff, including the CNMs had an understanding of the peer review process.

The Surveyor interviewed the Chief of Medicine/Chair of the Medical Staff, (Physician #1), on 2/4/14 at 1:00 P.M. Physician #1 said that there was not a well-designed model of Obstetrician and Certified Nurse Midwife collaboration, although it was developing. Physician #1 said the Certified Nurse Midwives needed closer supervision.

Physician #1 said she had not reviewed the specifics of the maternal and neonatal death cases because the cases were sent to external peer review secondary to a small OB department. Physician #1 said that the reports of Patient #1 and #2 will come to MSQIC (Medical Staff Quality Improvement) for review.

Physician #1 said that cases presented for peer review are scored and a score or 3 or 5 for 3 cases would trigger a review by the Focused Professional Practice Evaluation (FPPC). Physician #1 said that the peer review process was changing to reflect a more robust review.

Physician #1 said that the internal peer review system did not identify common provider or system themes, requiring a performance improvement plan.

The Surveyor interviewed the Obstetrician Expert Consultant (OBEC) on 2/3/14 at 1:00 P.M. The OBEC said that he started to work on his assessment of the Obstetric Service on 1/28/14 and he received the Obstetric service policies and procedures on 2/3/14.


The OBEC said he made an overview assessment of the Obstetric service and said he had not reviewed the medical records of Patient #1, #2 or #3.


The Surveyor interviewed OB #2 on 2/4/14 at 12:30 P.M. OB #2 said that the CNM's did not want to give up their independence.

The Surveyor interviewed Certified Nurse Midwife (CNM) #2 on 2/3/14 at 2:50 P.M., CNM #2 said the process of internal peer review was hit or miss and that she was not familiar with the peer review process because this had never happened before.

The Surveyor interviewed the Obstetric (OB) Department Chair on 2/4/14 at 11:00 A.M. The OB Department Chair said that he has reviewed all 3 cases, Hospital C was reviewing the OB Department and the care review reports from Hospital C, of Patient #1 and #2, were preliminary and the reports went to the Medical Staff Quality Improvement (MSQIC) committee 3-4 weeks ago. The OB Department Chair said that cases come to him for peer review by identified markers (for example low APGAR (newborn wellness) scores, injury) and were screened, evaluated for provider or system issues and request feedback from providers.

The OBEC said there was variation in provider practices, a lack of clearly defined OB and CNM roles and responsibilities. The OBEC said the OB's and CNMs did not share the same assessment, philosophy and view of the Obstetric service and practiced in isolation of each other.

The OBEC said that the nursing staff, although experienced, did not question the Obstetricians and CMNs. This compounded issues with the lack of communication in the Child Birth Center.

The Surveyor interviewed the Obstetric Department Chair on 2/4/14 at 11:00 A.M. The OB Department Chair said that issues regarding Patient #3's care were communication issues and demonstrated a need for formal communication training. The OB Department Chair said that issues regarding Patient #1 and #2's care were harder to trend.

5.) The Hospital failed to identify and resolve Obstetric providers' work fatigue.

The OB Department Chair said that 4 obstetricians (OB) had recently left the practice at the Hospital and 5 obstetricians remained.

The OBEC said the Obstetric staff was short-staffed due to providers leaving the practice. The OBEC said the Perinatal Committee (a multidisciplinary meeting of the Obstetric service and requirement of the Massachusetts Department of Public Health licensure regulations) was not meeting due to the obstetric staff workload.

The OBEC said the Hospital hired one temporary Obstetrician who started on 1/26/14, 2 OBs were starting on 3/1/14 and one CNM was starting on 4/1/14, but more physician coverage was needed. The OBEC said that the Obstetric physicians were short-staffed since October 2013. The OBEC said that he did not know how the Obstetric providers could not be fatigued.

The OBEC said that he questioned if there was enough time allotted for the Obstetric Chair to conduct quality improvement activities. Presently eight hours per month was allotted to the Obstetric Chair and the OBEC said that this was not enough time to conduct administrative and quality improvement responsibilities.

During an interview, on 2/4/14 at 12:30 P.M., OB #2 said that he was on-call for the Obstetric service every other night since October, due to short staffing. OB #2 said he was tired.

The OB Department Chair said the goal was to have a total of 8 obstetric providers. He said that 1 MD was contracted and started call on 2/3/14, another MD was starting on 2/3/14 and 1 MD was due to start 4/1/14. The OB Chair said they they were looking for 2 temporary OB physicians to cover weekends.

The OB Department Chair said that it has been a hard 3 months due to short-staffing and the maternal and newborn deaths.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on record review for 3 of 12 sampled patients (Pts.#1, #2, #3), interviews and review of the Hospital's policies titled, Chain of Command in Resolving Conflicts and Fetal Monitoring, the Hospital failed to ensure a well organized nursing service as evidenced by two unexpected neonatal deaths and one maternal death.

Findings include:

1.) The Hospital failed to ensure that for two patients (#1 and #3), they received quality nursing care. The Nursing Service failed to ensure staff implemented the Hospital's policy titled Chain of Command in Resolving Conflicts and Fetal Monitoring which contributed to the death of Patients #1 and #3.

See A-0386

2.) The Hospital failed to ensure Obstetric nurses caring for patients (undergoing cesarean sections in Child Birth operating rooms, (labor & delivery)) had the same standard educational requirements as nurses working in the main operating rooms.

See A-0392

3.) The Hospital failed to ensure staffing of the Child Birth Center met the needs of the patients.
VIOLATION: ORGANIZATION OF NURSING SERVICES Tag No: A0386
Based on record review of 2 of 12 sampled patients (Pts.#1 and #3), interviews, and review of the Hospital's policies titled, Fetal Monitoring and Chain of Command in resolving Conflicts. The Hospital failed to ensure that patients received quality nursing care as evidenced by one maternal death and two neonatal deaths in the obstetric service.

Findings include:

1.) The Hospital failed to ensure that Patient #3 was monitored according to the Hospital's policy titled Fetal Monitoring and that Patient's #3 heart rate/rhythm concerns were communicated according to the Hospital's policy titled Chain of Command in Resolving Conflicts.

The policy titled, Chain of Command in Resolving Conflicts, dated 11/09, indicated the process using the chain of command to resolve a conflict when initial actions were unsuccessful.

The Hospital policy titled, Fetal Monitoring, dated 5/2013, indicated that the policy indicated that the baby's heartbeat pattern and the mother's uterine activity will be documented every 30 minutes - 60 minutes during the first (early to active) stage of labor and every 15 minutes during the second (pushing) stage of labor.

Review of the Labor and Delivery (L&D) Notes, written by Certified Nurse Midwife (CNM) #1, on 1/20/14, indicated Patient #3's heart beat pattern and the mother's uterine activity was not documented, as required, every 30 minutes to 60 minutes during the first stage of labor and every 15 minutes during the second stage of labor, in accordance with the Hospital policy titled, Fetal Monitoring.

The Surveyor interviewed RN #1, on 2/3/14 at 4:30 P.M., RN #1 said that she told CNM #1, that Patient #3's was heart rate at 100 beats per minute ((BPM) normal range 110 to 160 BPM)), then 80 BPM, then 60 BPM, then she could not obtain the baby's heartbeat and the baby was delivered without a heartbeat. RN #1 said that the fetal monitor was recording the baby's heartbeat in a "W" pattern (abnormal and potentially life threatening) and that she was concerned with the situation. RN #1 said that CNM #1 restarted the Pitocin then increased the Pitocin and she (RN #1) did not like this decision. RN #1 said that the Charge Nurse asked if they were sure they were recording the baby's heartbeat. RN #1 said she told Obstetrician (OB) #2, specifically, about the fetal heart pattern and expected him to come and assess the situation in the room but he did not. RN #1 said that she wished someone had taken her concerns more seriously.

RN #1 said she did not consult with the Charge Nurse or an Obstetrician regarding her concerns until approximately 15 minutes prior to the delivery. This was not consistent with the Hospital's policy titled Chain of Command in Resolving Conflicts.

The Surveyor interviewed the Risk Manager on 1/31/13 at 11:45 A.M. The Risk Manager said that the Hospital Internal Investigation indicated that RN #1 did not communicate her concerns according to the Hospital's Chain of Command policy.

2.) The Surveyor interviewed RN #5 on 2/4/14 at 2:30 P.M. RN #5 said that Patient #1 presented to the Child Birth Center (CBC) on observation status. RN #2 said that Patient #1's blood pressure was extremely high, she was nauseated and vomiting, had a history of migraine head aches and was "screaming" about the pain of the headache. RN #5 said that her first assessment was that Patient #1 had the flu and looked sick. RN #5 said that Patient #1's second blood pressure was also high and her third assessment was that Patient #1 was pre-eclamptic ( had a life threatening complication of the last months of pregnancy, with symptoms of headache, swelling of the feet, dizziness, sudden weight gain, nausea vomiting abdominal pain and late symptoms of changes in mental status and impending seizures), and was about to have a seizure. RN #5 said she did not recall if she communicated her assessment to anyone.

Record review indicated Patient #1 was intubated and taken to the operating room on the labor and delivery unit for delivery of the baby via cesarean section.

Record review indicated Patient #1 remained unconscious after delivery of the baby and was transferred to the Intensive Care Unit (ICU). Once stabilized, a CAT( computerized axial tomography) scan was done of her head which revealed a massive cerebral hemorrhage (stroke). Patient #1 was transferred via helicopter to Hospital C, where she later died .

3.) During an interview on 2/3/14 at 2:15 P.M., RN #2 said that the nursing staff was not afraid to communicate with the Obstetric providers but some Obstetric providers do not necessarily listen to their concerns.

4.) The Surveyor interviewed RN #4 on 2/3/14 at 3:15 P.M. RN #4 said that newer and less experienced nurses were less likely to challenge provider authority.

5.) The Surveyor interviewed RN #6 on 2/7/14 at 10:30 A.M. RN #6 said that some nurses (more recent hires with less experience) were more passive and needed more confidence and experience to initiate provider communication regarding patient care issues. RN #6 said that the relationship with the CNMs needed work.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on interview, the Hospital failed to ensure an adequate number of Obstetric staff to provide nursing care to 3 of 12 sampled (#1, #2 and #3) as well as all Obstetric patients. The Hospital assigned the Charge Nurse a patient care assignment and the Charge Nurse was not available to cover patient care when staff responded to a patient care emergency.

Findings include:

1.) The Surveyor interviewed RN #3 on 2/4/14 at 10:30 A.M. RN #3 said that she was the Charge Nurse the day Patient #1 presented to the Child Birth Center (CBC) from home. RN #3 said that she was not the usual Charge Nurse and that she had a patient care assignment.

2.) The Surveyor interviewed RN #5, on 2/4/14 at 2:30 P.M., RN #5 said she was the Charge Nurse the on the day Patient #2 was born. RN #5 said she also had a patient care assignment in the Nursery and she could not leave the Nursery unattended to assist other staff with Patient #2's delivery. RN #5 said there were no staff to attend to patients on the CBC until assistance arrived from other Hospital areas to care for patients. RN #5 said the previous charge nurse made out the assignment, she questioned the assignment and did not discuss the assignment with her Nurse Manager.

3.) The Surveyor interviewed the Nurse Manager (NM) on 2/3/14 at 8:30 A.M. and on 2/4/14 at 3:00 P.M. The NM said that it was not a problem that one of her experienced Charge Nurses was pulled from staffing the CBC to work on the implementation of an electronic documentation system. The NM said that the CBC was staffed to the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN, Obstetric nurses professional organization) Guidelines.

AWHONN, Guidelines for Professional Registered Nurse Staffing of Perinatal Units (2010), indicated that charge nurses should not ideally have patient assignments so they can oversee clinical and unit operations and mentor nurses with less experience in perinatal nursing. In times of high census, short-term patient assignments, such as acting in the role of baby nurse at birth or caring for a woman who presents for obstetric triage, are ideal to allow charge nurses to fulfill their supervisory responsibilities. It was acknowledged that charge nurses without patient care assignments may not be possible for small-volume perinatal services.

4.) During the interview with the NM, on 2/4/14 at 3:00 P.M., the NM said that the Nurse Educator (a vacant position) whose responsibilities included policy development and review, nursing practice evaluation and nursing education, were assigned to her and these responsibilities presented a struggle in addition to her role as nurse manager.

The Surveyor interviewed the Obstetrician Expert Consultant (OBEC) on 2/3/14, at 1:00 P.M. The OBEC said that the Nurse Manager was "swamped". The OBEC said writing policies was the responsibility of the NM and did not know of a plan for management of the NM's other workload.

The Surveyor interviewed the Obstetric (OB) Department Chair on 2/4/14, at 11:00 A.M. The OB Department Chair said that the CBC NM needed help with education and policy review and that the Hospital was looking for a permanent nurse educator.

5.) Patient #3 was not monitored, according to the Hospital's policy titled, Fetal Monitoring. The fetal monitoring pattern prior to Patient #3's delivery was not normal and the Certified Nurse Midwife did not listen to the Registered Nurse #1's concerns about the abnormal heart rhythms on the feta monitor. Patient #3 was delivered without a heart beat and could not be resuscitated.

The Surveyor interviewed RN #4 on 2/3/14 at 3:15 P.M. RN #4 said she could not remember when the last formal program for electronic fetal monitoring (EFM) was offered but it was more than 5 years ago.

The NM said that the last EFM course was in 2010 and all obstetric nursing staff attended. The NM said there was no training offered since 2010 for new hires. The NM said the Hospital did not have a policy regarding mandatory EFM education, but she said the professional standard was EFM education should be accomplished every 2 years. The NM said that there was a plan for either an EFM conference or an Internet EFM Course, although details (for example, dates the program was to be offered, staff scheduled to attend and budget allocation) for EFM education were not provided upon request of the Surveyor at the time of the survey.

The NM said that Hospital B, the closest higher level maternity center to the Hospital, only provides EFM education for their staff and does not provide EFM education to outside hospitals. Hospital B is a contracted service provider to this Hospital.

The Surveyor interviewed the Chief Nursing Officer (CNO) on 1/31/14 at 4:00 P.M. and on 2/3/14 at 8:30 A.M. The CNO said she did not know when the nurses received EFM training.

6.) According to Taber's Encyclopedic Medical Dictionary, Edition 20, a cesarean section is a surgical procedure for removal of the fetus, placenta and membranes through an incision in the abdominal and uterine walls.

The NM said that the nurses who provide perioperative nursing care, (care of patients immediately before, during and right after surgery), to cesarean section patients in the Child Birth Center operating room (Labor and Delivery rooms), are not required to have Advanced Cardiac Life Support (ACLS) training, even though ACLS is a Hospital requirement for nurses who work in perioperative nursing areas. The NM said Labor and Delivery staff are only trained in cardiac dysrhythmia (irregular heart beat) recognition where as nurses in the main operating room all are ACLS trained.

The NM could not say why there was a difference in the standard of nursing care provided to OB surgical patients and the main OR surgical patients.