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HEALTHALLIANCE HOSPITAL BROADWAY CAMPUS 396 BROADWAY KINGSTON, NY 12401 April 21, 2015
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on medical records reviews, policies reviewed, documents reviewed and staff interviews, it was determined the facility failed to ensure that the medical staff provided timely, effective and appropriate medical care to the patients and the quality of the medical care was not consistent with prevailing standards of practice. Specifically, the medical staff (1) failed to distinguish if there was fetal distress and or fetal demise; and (2) failed to provide timely and effective medical care For specific finding #1 this was found in 4 of 4 sampled medical records reviewed. This was found in medical records (patients) #s 1, 4, 12, and 13. For specific finding #2 this was found in 2 of 9 medical records reviewed. This was found in medical records (patients) #s 3 and 14.

Findings include:

A determination of immediate jeopardy (IJ) was declared on April 15, 2015 at 4:00 PM when it was identified that the medical staff assigned to work on the obstetric unit (1) was not capable to assess, diagnose and provide emergency care to the obstetric patients that presented to the facility; and (2) failed to initiate effective resuscitation measures for a newborn infant in cardio-pulmonary arrest. Before the Immediate Jeopardy could be removed the facility was required to formulate and implement a corrective action plan that satisfactorily addressed all issues.

The immediacy of the IJ was abated at 5:20 PM on April 15, 2015.

The IJ was lifted / removed on April 21, 2015 at 5:00 PM when the facility provided evidence of ongoing training and protocols to address the issues identified in the IJ. The Condition level deficiencies remain.

Physicians and residents assigned to the obstetric unit did not identify whether a fetus was in fetal distress or fetal demise. Refer to Tag A 347 for detailed findings.

The facility failed to ensure that the medical staff followed its policies that a qualified obstetrician would be present for all deliveries. Refer to Tag A 347 for detailed findings.

The medical staff did not provide appropriate, timely and adequate resuscitative measures for patient #1 when the neonate did not respond to stimulation and or showed no signs of life. Specifically, the neonate was not intubated in a timely manner nor was Epinephrine administered in a timely manner. Refer to Tag A 347 for detailed findings.

The medical staff did not conduct physical examinations on some of the neonates (newborn infants) that were in respiratory distress when they were born, and in those cases where physical examinations were completed, they were not completed in a timely manner. Refer to Tag A 347 for detailed findings.

The medical staff did not reassess and adequately stabilize neonates that were identified as being in distress immediately after they were born. Refer to Tag A 347 for detailed findings.

The medical staff did not initiate transfers in a timely manner for neonates that were in distress and that required intensive and critical care which could not be provided at this facility. Refer to Tag A 347 for detailed findings.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical records reviews, reviews of policies, document reviews and staff interviews, it was determined the governing body was not effective in its role to ensure that medical staff provided quality, timely, adequate and appropriate medical care to patients that required critical and intensive care. Specifically, the medical staff failed to promptly differentiate if fetus and neonates were in distress and failed to provide immediate, appropriate and stabilizing medical care for 4 of 11 medical records reviewed. This was found in medical records #s 1, 4, 12 and 13.

Findings includes:

(1) The medical staff failed to identify or determine if patient #1 (medical record #1), was in fetal distress when the patient's mother (patient #2) presented to the facility in labor. A review of medical record #1 on April 15, 2015 at 1:15 PM revealed patient #2 presented to the facility's emergency department on December 29, 2014 and was admitted to the facility at 1:52 AM that morning. Patient #2 is a twenty-nine year old patient with a gestational age (pregnancy) of 38 weeks and 5/7 days. The EDC (expected date of confinement-due date to deliver) was January 11, 2015.

During an interview which was conducted on April 20, 2015 at 1:05 PM the nursing supervisor stated she placed patient #2 (mother) in a wheelchair and began to transport the patient to the obstetric unit. She also stated during this process she had to attend to another emergency so she instructed an ED technician to transport the patient to the obstetric unit. The emergency department (ED) technician's transporting the patient in labor was not appropriate because she did not have the skills to provide care to the neonate in this setting while en-route to the obstetric unit.

During a review of the medical record on April 14, 2015 it was noted that patient #2 arrived on the unit at 1:55 AM and according to the nurse's notes the patient was in imminent labor. The patient was groaning and writhing and was having contractions which had started at 11:00 PM that night (12/28/14). The fetal heart rate could not be detected initially, but heart
beats of 80 to 90 per minute were detected at 2:01 AM. The staff could not determine if this finding was a fetal heart rate or the mother's heart rate. A PGY 1 (first year resident) was contacted and performed an examination which revealed that patient #2 was 10 cm/100%/+2 station [cervix dilated 10 centimeters (cm) in diameter or 100% dilated, 2 station (the fetal presenting part is 2 cm below the ischial spines)] which is indicative of an imminent delivery of the neonate. This resident contacted the PGY III (third year resident) at 2:13 AM who arrived on the unit at 2:15 AM that morning. The on call obstetrician was notified at 2:15 AM.

[Note: Station refers to the relationship of the fetal presenting part to the level of the ischial spines (from the posterior border of the body of the Ischium, which forms the lower back part of the hip bone, there extends backward a thin and pointed triangular eminence, the ischial spine, which is more or less elongated in different subjects). When the presenting part is at the ischial spines the station is 0, which is synonymous with engagement. If the presenting fetal part is above the spines, the distance is measured and described as minus stations, which range from -1 to -4 cm. If the presenting part is below the ischial spines, the distance is stated as plus stations which range from +1 to +4 cm].

The nurse manager of the obstetric unit stated in an interview conducted on April 14, 2015 at 10:55 AM that an obstetrician is required to be present at each delivery as per facility policy. A written policy for this practice was not provided.

Since the patient was likely to delivery immediately and a fetal heart was uncertain, notification of the obstetrician at 2:15 AM was not timely since the patient arrived at the facility at 1:52 AM and the mother could have delivered the neonate at any moment.

A review of medical record #2 on April 14, 2015 revealed the patient delivered a female infant at 2:30 AM with a tight nucal cord X 1 (umbilical cord wrapped tightly around the neck once). The cord was removed and it was noted that the infant was flaccid, blue, mottled and there was no respiratory effort. The infant was stimulated then positive pressure ventilation (PPV) was started with 40% oxygen (O2) with a T piece. The APGAR (Appearance, Pulse, Grimace, Activity and Respiration) score was 0 at 1 minute (range 0- no signs of life to 10 a normal healthy response at birth) and the infant was stimulated (rubbing of the chest and back). At 2:32 AM chest compressions were started. The obstetrician arrived at 2:45 AM and immediately examined the mother. There was no documentation in the medical record that the obstetrician attended to the baby.

A review of the facility's policy titled "Code Blue Procedure-Neonatal" which was last approved on 7/31/14 revealed "a neonatal code blue may be called when a fetus or neonate has a perceived potential or documented need for resuscitation. This may include, but is not limited to, apnea or bradycardia unresponsive to stimulation, ineffective respiration or gasping with or without bradycardia, cyanosis, cardiac arrest, or delivery of a neonate not making appropriate transition and needing urgent intervention and supportive care." This policy also indicates that Epinephrine should be given within 90 seconds.

The medical staff failed to follow this policy as intubation, which is an important component of resuscitation, was not performed in a timely manner, nor was the administration of Epinephrine which was given 25 minutes after the medical staff's awareness that the neonate did not have a heart rate.

A review of medical record #1 on April 14, 2015 revealed the infant was intubated at 2:48 AM by an intensivist, 18 minutes after she was born with the APGAR score of 0 at 1 minute.

This was not a timely intubation since the APGAR score was 0 at 1 minute, 0 at 5 minutes and 0 at 10 minutes. Epinephrine was given at 2:55 AM via the endotracheal tube (ETT). This was also not timely given the patient's status at birth.

According to the medical record the nurse practitioner who had a specialty in neonatology arrived on the unit at 2:58 AM, almost hour after the infant was born and inserted an access into the umbilical vein at 3:02 AM. One cubic centimeter (cc) of Epinephrine was given by the vein at 3:03 AM and another dose was given at 3:07 AM into this vein. A 20 cc bolus of normal saline was administered at 3:03 AM.

The invasive measures, intubation and administration of drugs and fluids were not performed in a timely manner.

During an interview which was conducted on April 15, 2015 at 10:25 AM the PGY III stated that he did not attempt to intubate the patient #1. During an interview conducted on April 15, 2015 at 11:25 AM, the PGY 1 stated the mother arrived on the unit screaming at the top of her lungs and she was in severe pain. She stated she examined the patient and discussed her findings with the PGY III. She also stated that after the PGY III arrived on the unit she did not assist with the delivery or the resuscitation of the baby. She stated she was just observing and didn't attend to the mother and the baby. She did not call a code and did not make any attempt to intubate the baby. She also stated that she had passed a neonatal resuscitation program (NRP) training.

PGY III also stated on April 15, 2015 at 10:25 AM that he did not call a code nor did he attempt to intubate the baby. This resident also stated he had received training in NRP.

The registered nurse assigned to the patient stated on April 20, 2015 at 11:40 AM that a code should have been called at approximately 2-3 minutes after birth when the baby remained unresponsive after she was stimulated. She also stated that she did not call a code and that it was not in the scope of practice for registered nurses to intubate a neonate.

The above sequence of events were not timely and did not meet current standards of practice.

2 (a). Physical assessments were not performed or completed in a timely manner. A review of medical record # 4 on April 21, 2015 revealed this neonate was delivered at 8:54 PM on February 5, 2015 with an APGAR score of 0 at 1 minute. There was no gasp or breath at delivery. There was no documented evidence that a medical practitioner conducted a complete physical assessment. Oxygen was administered and at 8:56 PM the neonate began to breathe and 2 minutes later the oxygen saturation was identified as 70% (the normal range is 96-100%). The nursing staff provided continuous nursing care. The first heart rate was in the 170's at 9:04 AM with the oxygen saturation at 86%. The neonate's heel stick was 262 at 9:21 PM and 182 at 10:02 PM (normal range 70-110) with respiratory rate in the 80's. The baby was placed on CPAP (continuous positive airway pressure) at 5 FiO2 at 40% (FiO2 is the fraction or percentage of oxygen in the space being measured. Natural air includes 20.9% oxygen. If a patient is wearing a nasal cannula or a simple face mask, each additional liter of oxygen adds about 4% to their FiO2, so in this case, patient #1 with 5 liters of oxygen attached would have an FiO2 of 21% + 20% =41%) which resulted in an oxygen saturation that gradually increased to 94-98% at 10:02 PM. At 12:45 AM on February 6, 2015 the saturation decreased to 91% so the CPAP was increased to 6. The heel stick was 66 at 1:15 AM. The team from the tertiary facility arrived at 1:55 AM, obtained an intravenous access and stabilized the neonate before it was transferred from the facility at 2:35 AM on February 6, 2015, five hours after the infant was delivered.

(b) In medical record #13 the patient was delivered on February 9, 2015 at 9:30 PM with an APGAR score of 3 at 1 minute (2 for heart rate and 1 for color). With oxygen therapy the APGAR score increased to 7 at 5 minutes after birth and 10 at 10 minutes after birth. The infant had retractions with labored and irregular spontaneous breathing at 9:33 PM via positive pressure ventilation. The neonate was not responding so the oxygen was increased to 100%. At 9:35 PM the family practice attending (FPA - responsible for caring for the neonates) was notified and arrived at 9:39 PM. The oxygen was decreased to 40% at 9:44 PM with the oxygen saturation at 96%.

A review of the medical record # 13 on April 21, 2014 revealed at 11:40 PM the nursing staff documented that the neonate had nasal flaring and the FPA was notified. However the medical staff failed to obtain an intravenous access despite "multiple attempts" and the physical assessment was completed 2 hours after birth despite the unstable condition of the neonate. The FPA documented the infant was "premature and stable." The neonate was not stable at this point. The newborn was subsequently transferred at approximately 5:20 AM, seven hours after the infant's birth, and after the recipient facility arrived at the facility and stabilized the infant. The physician decided to transfer the infant when the nurse informed him that she was not "comfortable" in taking care of the infant who was still in respiratory distress and had not been intubated.

(c) In MR #12 which was reviewed on April 21, 2015, revealed the neonate was delivered at 10:05 PM on January 5, 2015 via a Cesarean Section which was performed for fetal distress, a prolapsed cord, variable decelerations and terminal meconium (occurs when the fetus passes the meconium, the earliest stool of an infant - composed of materials ingested during the time the infant spends in the uterus, a short enough time before birth/caesarean section that the amniotic fluid remains clear, but individual clumps of meconium are in the fluid). The APGAR score was 6 at 1 minute, but the infant was in respiratory distress as evidenced by labored breathing and retractions and the neonate had oxygen saturation at 86% despite oxygen therapy. At 10:13 PM the oxygen saturation was between 73-75% with the heart rate in the 100's (normal range 130-160). The infant was suctioned and meconium and blood tinged mucus was retrieved from the mouth. The respiratory rate had increased to 89 with retractions still persisting and the oxygen saturation at 90% at 11:15 PM that night.

A review of medical record #12 on April 21, 2015 revealed a complete physical assessment was performed 2 hours later at 12:00 AM after the infant's birth At 12:10 AM the saturation had decreased to 88% and the oxygen was adjusted. The infant was transferred for management of respiratory distress at 3:10 AM after the recipient facility arrived at 2:15 AM and stabilized the infant at this facility.

The facility failed to obtain intravenous accesses for patients #s 4, 12 and 13 despite the neonates critical and unstable conditions.

The facility failed to ensure that the medical staff provided critical and intensive care to the neonates, care that included, but was not limited to, intubation, insertion of peripheral accesses, administer fluids and antibiotics and monitor labs and intake and output. In addition, the medical staff failed to initiate and facilitate transfer of the neonates from this hospital that provided Level 1 Perinatal Services in a timely manner.

(3) A review of medical record #3 on April 21, 2015 revealed on August 26, 2014, this fifty-four year old patient presented to the facility and was diagnosed with [DIAGNOSES REDACTED]], Anemia, [DIAGNOSES REDACTED], Chronic Respiratory failure, PEG, Electrolyte Imbalance, Sepsis, Stage 4 Ulcers, GI bleeding (gastrointestinal), and Schizophrenia. The patient was sent to the hospital with Septic Shock, Dehydration, Hypotension, AKI (acute kidney injury), Hyperkalemia, Lactic Acidosis, Leukocytosis, Stage 4 sacral decubitus ulcer, and Altered Mental Status.

At 3:35 PM, the patient was triaged in the emergency room . At 7:00 PM, the patient vomited coffee ground emesis and was transferred to Intensive Care Unit (ICU) for further evaluation and treatment. While in ICU, a "Code Blue" was called for the patient on 2 occasions. The first time, the "Code Blue" was activated on August 26, 2014 at 5:11:00 AM, by an MD who also stopped the code at 5:15 AM; and, as a result was questioned by the Medical Director of the ICU unit. Review of facility's documents revealed that the MD who activated the "Code Blue" and then stopped it, did not follow the advanced cardiac life support (ACLS) guidelines. As a result, the standard of care for the patient was not met.

Two interviews were conducted with the intensive care unit (ICU) Director on April 20, 2015 at 02:30 PM and April 21, 2015 at 2:07 PM. On April 21, 2015, the Director stated that she received a phone call from a nurse on duty stating that the hospitalist on duty stopped the code. The ICU director stated that it took her about 15 minutes to arrive to the facility. The ICU director was unsure whether the patient was in supraventricular or ventricular rhythm with a pulse and stated that the patient was in extremisis hypotensive with a respiratory rate of 50 breaths per minute. The ICU Director intubated the patient and ordered vasopressors (any medication that tends to raise reduced blood pressure).

Review of patient's medical record #3 on April 20, 2015 revealed that on August 26, 2014, a "Code Blue" was activated at 05:11. The patient was intubated by the ICU director on August 26, 2014 at 06:00 immediately upon arrival to the unit.

The hospitalist failed to act after the activation of the "Code Blue" according to ACLS guidelines and the commonly accepted standards of care. The code was stopped and the care was not provided until the arrival of the ICU Director to the unit. The patient's airway was not managed as per ACLS guidelines in a timely manner. As a result, the care was delayed and the standard of care was not met.

The hospitalist's note on August 26, 2014 at 8:20 AM, was not legibly written and was not significant from a clinical perspective.

(4) Review of the medical record # 14 on April 21, 2015 revealed that on July 24, 2013, a ninety-one year old patient with a history of Endocarditis, [DIAGNOSES REDACTED], Left Lower Extremity Deep Vein Thrombosis, and Hypertension presented at the hospital after a fall at home.
On July 29, 2013, during her hospital stay, a rapid response team was called for the patient who was in supra[DIAGNOSES REDACTED] (SVT is a cardiac arrhythmia, in this case a rapid heart rhythm, arising from improper electrical activity of the heart). The patient was intubated. For the sedation, prior to intubation, a hospitalist ordered Versed 2 milligrams via intravenous (2 mg via IV) which was followed by Etomidate 20 mg via IV. Intravenous is the infusion of liquid substances directly into a vein.

During the interview with the ICU Director on April 21, 2015 at 2:30 PM, the Director stated that "only an anesthesiologist can order this medication. If the patient is septic, it can lead to Adrenal Insufficiency, which can lead to Hypotension, - and the patient may die."

A review of the hospital's "Code Blue Procedure " policy last reviewed 8/20/14 paragraph 4.6, states "Rapid sequence intubation (RSI) medications .... Will be restricted to only those practitioners qualified to administer them [Anesthesiologist, Intensivist, Emergency Medicine Physicians].

The physician who ordered Etomidate 20 mg IV is a hospitalist. This hospitalist was not privileged by the medical staff to order Etomidate and did not follow the hospitals' Code Blue policy.