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725 NORTH STREET

PITTSFIELD, MA 01201

QAPI

Tag No.: A0263

Based on records reviewed and interviews for one (Patient #2, a newborn) of ten sampled patients, the Hospital failed to maintain an effective quality assessment and performance improvement program.

Findings include:

The Hospital failed to accurately identify the severity of injury level for one (Patient #2) of ten sampled patients, as potential harm, and send the written reports to the Medical Peer Review Committee for review.

Refer to TAG: A-273.

The Hospital failed to ensure that performance improvement activities accurately analyzed Patient #2's adverse outcome as potential patient harm so the incident would be reviewed by physicians. The inaccurate identification of the severity of injury level had a potential to lead to the continuation of unsafe practices in neonatal assessments and neonatal resuscitation.

Refer to TAG: A-286.

The Hospital failed to follow their own policies related to identifying the severity level of an adverse event that indicated a potential for patient harm, resulting in no communication to the Peer Review Committee and interdisciplinary Quality Improvement Committees to review Patient #2's incident. A potential for patient harm resulted in the continuation of issues with neonatal assessment and resuscitation without corrective actions by the Hospital.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on records reviewed and interviews, the Hospital failed to monitor the effectiveness and safety of services and quality of care when they failed to accurately identify the severity of injury level for one (Patient #2, a newborn) of ten sampled patients as potential harm and send the written reports to the Medical Peer Review Committee for review.

Findings include:

Patient #2's record indicated that 1 hour and 50 minutes after delivery (birth), he/she was noted to be blue (a sign of inadequate oxygen) and was unresponsive. Patient #2 had no pulse and no respirations, a cardiac and respiratory arrest, required basic and advanced cardiac life support.

The Hospital Policy, Patient Event Reporting Utilizing the Quality Tracking Form, dated 5/15/16, indicated that the Patient on Line Quality Tracking Form (QTF) must be completed for all events involving patients within the Hospital. An event is a situation that results in a real potential adverse outcome and includes, but is not limited to, patient related events. The Patient on Line Tracking Form System will use the severity of injury scale levels as: 4 levels, Level 0-No injury, disability or near miss, up to Level 3-death. The policy indicated that the Patient Safety Director and/or Performance Improvement Specialist will review all Quality Tracking Forms and the significance will be added.

The Maternity Recovery Record, undated, indicated that Patient #1 had significant vaginal bleeding requiring two different injectable medications to maintain the uterine tone (used to decrease bleeding).

On 7/27/18 at 6:08 A.M., Hospitalist #1 was involved in the neonatal code during which time she intubated (inserting an endotracheal tube into the main airway for air exchange) and attempted to ventilate Patient #2 four times. The air leaked around the endotracheal tube and another larger endotracheal tube needed to be reinserted and with subsequent intubations the oxygenation of Patient #2 decreased to approximately 70 to 80% (normal is greater than 90%). The intubations were complicated by blood in the airway which required suctioning and a concern with the bag valve mask working to adequately inflate the lungs for respiratory ventilations. Post cardiac and respiratory resuscitation, Patient #2 sustained a pneumothorax (a collapse of the lung). Patient #2 was transferred to a tertiary care facility and admitted to the Neonatal Intensive Care Unit. Patient #2 died six days later from a hypoxic (inadequate oxygen) brain injury sustained on 7/27/18 caused by respiratory failure and seizures.

The Surveyor interviewed the Director of Patient Safety at 8:40 A.M. on 1/16/19. The Director of Patient Safety said that she coded Patient #2's incident as a Level 0 - no injury or disability; therefore, this event was not referred to Hospital Peer Review or to the other Quality Assurance Committees.

Patient #1 and Family Member #1 were interviewed at 5:03 P.M. on 1/14/19. Patient #1 and Family Member #1 said that after delivery, Patient #2 had difficulty breathing, was gurgling (a sign of not being able to clear his/her airway), had excessive drooling and required suctioning at birth and again approximately 8 minutes later. Family Member #1 said he requested that Patient #2 needed suctioning for the second time because of the gurgling coming from Patient #2's airways.

Nurse #1 was assigned to both Obstetric Patient #1 and Patient #2, a newborn.

The vital signs for Patient #2 were not obtained every 30 minutes for the first 2 hours after birth, vital signs were omitted at 5:15 A.M. and 5:45 A.M. 7/27/18.

No breast feeding assessment was done.

The failure of the Hospital to accurately identify the severity of injury indicated a potential for patient harm and resulted in no referral to the Peer Review Committee and interdisciplinary Quality Improvement Committees to review Patient #2's incident. A potential for patient harm resulted in the continuation of issues with neonatal assessment and resuscitation without corrective actions by the Hospital.

PATIENT SAFETY

Tag No.: A0286

Based on records reviewed and interviews for one (Patient #2, a newborn) of ten sampled patients, the Hospital failed to analyze and take preventative action when the Hospital failed to ensure that performance improvement activities accurately analyzed Patient #2's adverse outcome, death. The inaccurate identification of the severity of injury level lead to the continuation of unsafe practices in neonatal assessments and neonatal resuscitation.

Findings include:

Patient #2's record indicated that 1 hour and 50 minutes after delivery (birth), he/she was noted to be blue (a sign of inadequate oxygen) and was unresponsive. Patient #2 had no pulse and no respirations, a cardiac and respiratory arrest, required basic and advanced cardiac life support.

The Hospital Policy, Patient Event Reporting Utilizing the Quality Tracking Form, dated 5/15/16, indicated that the Patient on Line Quality Tracking Form (QTF) must be completed for all events involving patients within the Hospital. An event is a situation that results in a real potential adverse outcome and includes, but is not limited to, patient related events. The Patient on Line Tracking Form System will use the severity of injury scale levels as: 4 levels, Level 0-No injury, disability or near miss, up to Level 3-death. The policy indicated that the Patient Safety Director and/or Performance Improvement Specialist will review all Quality Tracking Forms and the significance will be added. The Patient Safety Director will coordinate the investigation of significant events, using the Root Cause Analysis Process, when needed and as directed by the Patient Care Assessment Coordinator, Chief Operating Officer, Chief of Staff, and or Chief Quality Officer.

The Maternity Recovery Record, undated, indicated that Patient #1 had significant vaginal bleeding requiring two different injectable medications to maintain the uterine tone (used to decrease bleeding).

On 7/27/18 at 6:08 A.M., Hospitalist #1 was involved in the neonatal code during which time she intubated (inserting an endotracheal tube into the main airway for air exchange) and attempted to ventilate Newborn #2 four times. The air leaked around the endotracheal tube and another larger endotracheal tube needed to be reinserted and with subsequent intubations the oxygenation of Patient #2 decreased to approximately 70 to 80% (normal is greater than 90%). The intubations were complicated by blood in the airway which required suctioning and a concern with the bag valve mask working to adequately inflate the lungs for respiratory ventilations. Post cardiac and respiratory resuscitation, Patient #2 sustained a pneumothorax (a collapse of the lung). Patient #2 was transferred to a tertiary care facility and admitted to the Neonatal Intensive Care Unit. Patient #2 died six days later from a hypoxic (inadequate oxygen) brain injury sustained on 7/27/18 caused by respiratory failure and seizures.

The Surveyor interviewed the Director of Patient Safety at 8:40 A.M. on 1/16/19. The Director of Patient Safety said that she coded Patient #2's incident as a Level 0 - no injury or disability; therefore, this event was not referred to Hospital Peer Review or to the other Quality Assurance Committees.

Patient #1 and Family Member #1 were interviewed at 5:03 P.M. on 1/14/19. Patient #1 and Family Member #1 said that after delivery, Patient #2 had difficulty breathing, was gurgling (a sign of not being able to clear his/her airway), had excessive drooling and required suctioning at birth and again approximately 8 minutes later. Family Member #1 said he requested that Patient #2 needed suctioning for the second time because of the gurgling coming from Patient #2's airways.

Nurse #1 was assigned to both Obstetric Patient #1 and Patient #2, a newborn.

The vital signs for Patient #2 were not obtained every 30 minutes for the first 2 hours after birth, vital signs were omitted at 5:15 A.M. and 5:45 A.M. 7/27/18.

No breast feeding assessment was done.

The Surveyor interviewed the Director of Patient Safety at 7:52 A.M. on 1/15/19. The Director of Patient Safety said although she was notified of Patient #2's incident on 7/27/18 by the Director of Maternal Child Health, she did not analyze or track this incident with a root cause analysis as per their policy because it was not a preventable event.

The Surveyor interviewed the Director of Patient Safety at 8:40 A.M. on 1/16/19. The Director of Patient Safety said that she coded Patient #2's incident as a Level 0 - no injury or disability; therefore, this event was not referred to Hospital Peer Review or to the other Quality Assurance Committees.

The failure of the Hospital to accurately identify the severity of injury indicated a potential for patient harm and resulted in no root cause analysis of this significant event, no referral to the Peer Review Committee and interdisciplinary Quality Improvement Committees to review Patient #2's incident. A potential for patient harm resulted in the continuation of issues with neonatal assessment and resuscitation without corrective actions by the Hospital.

MEDICAL STAFF

Tag No.: A0338

Based on interviews and records reviewed of one (Patient #2, a newborn) of ten sampled patients, the Medical Staff Bylaws and the document titled, Medical Staff Policy on Peer Review, the Medical Staff failed to ensure the quality of medical care provided to patients by the Hospital.

The Medical Staff failed to ensure to the Governing Body that Hospitalist #1's Medical Staff privileges were not solely dependent on current neonatal resuscitation training programs.

Refer to TAG: A-341

The Governing Body (GB) failed to ensure that the Medical Staff was accountable to the GB for the quality of care provided to patients.

Refer to TAG: A-347

The Medical Staff failed to enforce their own Medical Staff Bylaws to carry out its responsibilities in evaluating Medical Staff membership performance.

Refer to TAG: A-353

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on records reviewed and interviews, the Medical staff failed to ensure to the Governing Body (GB) that Hospitalist #1's Medical Staff privileges were not solely dependent on current neonatal resuscitation training programs when there was a low volume of neonatal codes and intubations at the Hospital to maintain competency with neonatal resuscitation.

Findings include:

Medical Staff Bylaws Article 2, Purpose, dated 10/18/16, indicated that one purpose is to assure a high level of professional performance by all providers authorized to practice in the Hospital, through the appropriate delineation of the clinical privileges that each Practitioner may exercise and through ongoing review and evaluation of each Practitioner's performance.

The Surveyor reviewed the credential record of Hospitalist #1 which indicated she had completed the Neonatal Resuscitation Program and Pediatric Advance Life Support (American Heart Association and American Academy of Pediatrics program on neonatal and pediatric resuscitation) and was re-certified in 11/2018. Hospitalist #1 finished her residency program at a tertiary care Hospital in 2017 and was board certified in Pediatrics and Medicine. Hospitalist #1 had provisional Hospital privileges, granted on 11/17/17, which included Maternal Child Health and Pediatrics for the management and diagnoses of complex neonatal illness, intubation and resuscitation.

Patient #2's record indicated on 7/27/18, Hospitalist #1 was involved in a neonatal code during which she intubated and attempted to ventilate Patient #2 (a newborn) four times. The air leaked around the endotracheal tube (a tube inserted into the main airway for air exchange) and another larger endotracheal tube needed to be reinserted and with subsequent intubations the oxygenation of Patient #2 increased to approximately 70 to 80 % (normal is greater than 90%). The intubations were complicated by blood in the airway which required suctioning and a concern with the bag valve mask working to adequately inflate the lungs for respiratory ventilations. Post cardiac and respiratory resuscitation, it was documented that Patient #2 sustained an opening in the lungs after the multiple intubations.

The Surveyor interviewed the Director of Obstetrics, Gynecology and Pediatrics at 10:00 A.M. on 1/15/19. The Director of Obstetrics, Gynecology and Pediatrics said that he performed a review of Patient #2's case (after he/she died). The Director of Obstetrics, Gynecology and Pediatrics said the care provided by Hospitalist #1 was appropriate and he did not refer this case to Medical Peer Review.

The Surveyor interviewed Hospitalist #1 at 10:48 A.M. on 1/16/19. Hospitalist #1 said that she was able to intubate Patient #2 with each endotracheal insertion but Patient #2's oxygen level would decrease after each insertion. Hospitalist #1 said she had been employed by the Hospital for one year and had a successful intubation of a newborn 4 months ago, before this survey. Hospitalist #1 said she could not recall any other recent newborn intubations, but there were not many neonate intubations at this Hospital.

The Surveyor interviewed Physician #3 at 9:00 A.M. on 1/22/19. Physician #3 said that, in lieu of Hospitalist #1 being a new Physician at the Hospital and due to the complexity of Patient #2's case with resuscitation, it would have been appropriate to submit this case to Medical Peer Review.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on interviews and records reviewed for one (Patient #2, a newborn), of ten sampled patients, the Governing Body (GB) failed to assure that the Medical Staff was accountable to the GB for the quality of care provided to patients.

Findings include:

Medical Staff Bylaws Section 10, Organization, dated 10/18/16, indicated that each department chairperson is responsible for all clinically related activities of the department, continuous surveillance of the professional performance of all individuals in the department who have delineated privileges and the continuous assessment and improvement of the quality of care and service provided.

The Medical Staff Policy on Peer Review, dated 4/30/16, indicated the policy was to facilitate Physician Peer Review at the Hospital. Peer Review will be conducted according to the provisions in the Medical Bylaws. The Medical Staff Peer Review Committee will review major incidents and occurrences with unexpected patient outcomes. Peer Review in each case should be conducted within three months of initial presentation to the Committee unless extended for exceptional circumstances and by approval of the Chief of Staff.

Review of Patient #2's medical record, indicated on 7/27/18, Hospitalist #1 was involved in a neonatal code in which she intubated Patient #2 four times. The air leaked around the endotracheal tube and another larger endotracheal tube needed to be reinserted and with subsequent intubations the oxygenation of Patient #2 decreased to approximately the 70 to 80% (normal is greater than 90%). The intubations were complicated by blood in the airway which required suctioning and a concern with the bag valve mask working to adequately inflate the lungs for respiratory ventilations. Post cardiac and respiratory resuscitation, Patient #2 sustained a hole it the lung after multiple intubations and died 6 days later.

The Surveyor interviewed the Chief Medical Officer at 4:03 P.M. at 1/15/19. The Chief Medical Officer said that, after the code for Patient #2, they had a multidisciplinary meeting with the physicians and nurses that were involved in the resuscitation effort. The care was reviewed and it was determined that Patient #2's incident and decline could not have been prevented, but it could have been improved. The review did not address the intubation and ventilation by Hospitalist #1 and the actions by Nurse #1. The areas for improvement included: education with neonatal ambu bags (used for administering artificial respiratory ventilation during a respiratory or cardiac code) mock codes, appropriate skin to skin training, having back up coverage with the Continuing Care Nurse (Nursery Nurse) and simulation training for a neonatal respiratory and/or cardiac arrest.

The Surveyor interviewed Respiratory Therapist #2 at 7:30 A.M. on 1/16/19. Respiratory Therapist #2 said she responded to the Patient #2's emergency code on 7/27/18, this was her first neonatal code and as of the date of survey she had not attended the Hospital mock neonatal codes offered during the past 2 to 3 months, identified as an area for improvement after Patient #2's cardiac and respiratory arrest.

The Chief Medical Officer said the case of Patient #2 did go to the Chairperson of the Peer Review Committee, but as of 1/15/19, the case had not gone to the Peer Review Committee, approximately 6 months after the incident on 7/27/18. The Chief Medical Officer said this went to the Chairperson of the Peer Review Committee because of the unusual circumstances, death of a newborn and airway maintenance.

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on records reviewed and interviews for one (Patient #2, a newborn) of ten sampled patients, the Medical Staff failed to enforce their own Medical Staff Bylaws to carry out its responsibilities in evaluating Medical Staff membership performance.

Findings include:

Medical Staff Bylaws Section 1, The Provisional Staff, dated 10/18/16, indicated that a member appointed on a provisional basis, active members, under the direction of the appropriate department chairman, shall have the responsibility of observing such member in the performance of his/her professional responsibilities.

Medical Staff Bylaws Article 11 Committees, Medical Staff Executive Committee, dated 10/18/16, indicated that the Medical Staff Executive Committee takes all reasonable steps to ensure professionally competent clinical performance on the part of all members of the Medical Staff, including the initiation of and/or participation in Medical Staff corrective or review measures when warranted.

The Surveyor reviewed the credential record of Hospitalist #1 which indicated Hospitalist #1 had a Provisional appointment to the Medical Staff and clinical privileges included management and diagnosis of complex neonatal illness with intubation and resuscitation.

The Surveyor interviewed the Chief Medical Officer at 4:03 P.M. on 1/15/19. The Chief Medical Officer said the case of Patient #2 had not gone to the Peer Review Committee, approximately 6 months after the incident on 7/27/18, although this was an unusual circumstance; death of a newborn and airway maintenance.

The Medical Staff failed to meet its responsibility as per the Medical Staff Bylaws failing to:

1.) Measure, monitor and evaluate Hospitalist #1's competency in neonatal resuscitation.

2.) Ensure Clinical Privileges included Hospitalist #1's competency in neonatal resuscitation and ensure that Medical Staff Membership and Clinical Privileges be granted solely on current courses in neonatal resuscitation.

3.) Effectively act upon the incident with Hospitalist #1 regarding the neonatal resuscitation skills with intubation and desaturation (decreased patient oxygenation) after intubation (differential diagnoses of other issues contributing to the desaturation).

4.) Forward Patient #2's unexpected death to the Peer Review Committee, creating a potential situation at birth, where a newborn would not be readily resuscitated and intubated with adequate oxygenation according to the American Heart Association and American Academy of Pediatrics standards for neonatal resuscitation and potential for patient harm.

NURSING SERVICES

Tag No.: A0385

Based on records reviewed and interviews the Nursing Service Condition of Participation was found to be out of compliance.

Findings include:

The Hospital failed for one (Patient #2, a newborn) of ten sampled patients to ensure that the Obstetric Nursing staff in Labor and Delivery were clinically competent in the nursing care of Newborns.

The Hospital failed for two of ten sampled patients (Patient #1 and Patient #2, a newborn) to ensure that the post-delivery staffing assignments were not dual assignments, with both an obstetric patient and a newborn assigned to only one nurse. Appropriate nursing assignments were needed in order to allow the required monitoring of Patient #1 and Patient #2, to detect a decline within the first 2 hours post-delivery, a critical time to monitor and evaluate a newborn's and an obstetric patient's stability and healthcare needs.

Refer to TAG: A-386

The Hospital failed for one (Obstetric Patient #1), out of 10 patients, to follow the care plan and the standards of practice for monitoring and documenting intake and output, related to actual blood loss to determine the obstetric patient's replacement needs and to assist in early detection of hypovolemic shock (loss of circulating blood volume-a life-threatening condition).

Refer to TAG: A-396

The Hospital failed for one (Nurse #1) of five Nursing Personnel Files reviewed to ensure the Nurse's performance and clinical competency were evaluated annually with the required performance appraisal.

Refer to TAG: A-397

ORGANIZATION OF NURSING SERVICES

Tag No.: A0386

Based on records reviewed and interviews for five (Patients #2, #4, #5, #9, all newborns and Obstetric Patient #1) of ten sampled patients, the Maternal Child Health Nursing staff failed to adequately assess and monitor newborns. Nurse #1 failed to document that she educated Patient #1 with the breast feeding method for maintaining an open airway in a newborn while attempting to nurse, 1 hour and 50 minutes after delivery Patient #2 became hypoxic. The Hospital failed to have a well-organized Maternal Child Health Unit with the delineation of nursing assignments in order to provide the necessary care to both a newborn and an obstetrical patient post-delivery.

Findings include:

Guidelines for Perinatal Care, 7th edition, American Academy of Pediatrics (the Hospital's standard of care), indicated that:
- The Neonatal Resuscitation Management Plan, after the initial evaluation of the newborn's condition, the newborn should be carefully observed during the subsequent stabilization- transition period (the first 2-24 hours after birth). If the infant is healthy and stable, the care plan should facilitate ongoing contact between the mother and the infant (e.g., rooming-in together) during this period. Temperature, heart and respiratory rates, skin color, peripheral circulation, respiration, level of consciousness, tone, and activity should be monitored and recorded at least once every 30 minutes until the newborn's condition has remained stable for 2 hours.

- Immediate Postpartum Maternal Care- Monitoring of maternal status postpartum is dictated in part by the events of the delivery process. Nursing staff assigned to the delivery and immediate recovery of a woman should have no other obligations.

-Parent education should include instruction on breastfeeding.

- (General) Positioning. The newborn can be positioned on either the back or the side, with the neck slightly extended. This position (known as the sniffing position) readily aligns the posterior pharynx, larynx, and trachea for optimal air entry, for both spontaneous breaths. The newborn's mouth and nose may be wiped with a towel or suctioned gently to remove excess mucus or blood.

The Hospital Policy, Care of the Newborn, dated 3/2014, provides guidelines to staff regarding initial care of the newborn. Neonatal admission assessments must be conducted within the first two hours of life. Assessments include physical assessment-vital signs, skin color, tone and activity every 30 minutes until newborn's condition is stable for the first two hours after birth and then once per eight hour shift. If the newborn is stable, encourage skin to skin contact between mother and baby.

The Staff Nurse Job Description, dated 10/2017, indicated for professional practice that the assessments and reassessments are accurate, timely, ongoing and communicated in a comprehensive manner, which is documented in real time in the medical record.

The Obstetrics, Gynecology Progress Note, dated 7/26/18, indicated Patient #1 was admitted for labor at 40 weeks pregnant (full-term) in no apparent distress.

The Obstetrics Delivery Note, dated 7/27/18 at 4:39 A.M., indicated Patient #1 received Pitocin (a medication which stimulates uterine contractions) augmentation and an epidural (a medication delivered outside of the spinal cord) for pain, reached full dilation and delivered a vigorous female infant with Apgar scores of 8 at 1 minute and 9 at 5 minutes (a score 7 to 10 is normal). There was a nuchal cord (when the umbilical cord becomes wrapped around the fetus's neck, outcomes are generally good, rarely long-term brain damage or cerebral palsy- a disorder of movement, muscle tone or posture) not known on admission, that was easily reduced. Mother and baby were stable at that time.

A. Patient #1's Delivery Summary, dated 7/27/18 at 4:30 A.M. indicated there were no maternal risk factors even though Obstetric Patient #1's maternal age was a risk factor, but the age risk factor section was left blank. (When the Obstetrical age was over age 34, there is an increased risk for fetal birth defects.)

Patient #2's Activity Assessment, dated 7/27/18, indicated vital signs:

- At 4:10 A.M. (at birth), pulse rate 160 (normal 120-160), respiratory rate 70 (normal 30 -60 - an elevated respiratory rate) and no temperature was taken as required per the Hospital's policy.

- At 4:45 A.M., an axillary (under the arm pit) temperature was 99.2 degrees (normal 97.9 - 99.7 degrees), pulse 160, and respiratory rate 50.

- At 5:00 A.M. (in Obstetric Patient #1's chart) Patient #2 to breast.

There was no documentation that the vital signs were performed again as required per the Hospital's policy (every 30 minutes for 2 hours) which would have been at 5:15 A.M. and then again at 5:45 A.M. to monitor Patient #2's condition.

The Surveyor interviewed Nurse #1 at 11:07 A.M. on 1/16/19. Nurse #1 said she omitted to perform Patient #2's vital signs at 5:15 A.M. and at 5:45 A.M. on 7/27/18, as per the Hospital's policy.

The Care Trends for Nutrition Note, dated 7/27/18 at 5:17 A.M., authored by Nurse #1 (who said documentation was not in real time, documented 15 minutes the weight was taken), indicated Patient #2's weight was 8 pounds and 13.5 ounces and height was 20.5 inches.

There was no documentation that breast feeding education had occurred, nor that any further assessment was performed on Patient #2 by Nurse #1 from 5:10 A.M. to 6:00 A.M. on 7/27/18.

Patient #1's medical record indicated that, at 6:00 A.M. on 7/27/18, she rang the call bell to report that Patient #2 had a bloody nose and was found to be unresponsive. Patient #2 was rushed to the Nursery to be evaluated. The last vital signs had been performed at 4:45 A.M., one hour and 15 minutes previously, not every 30 minutes according to their policy (vital signs provide critical information to assess the newborns well-being or decline in condition).

The Surveyor interviewed Patient #1 and Family Member #1 at 5:03 P.M. on 1/14/19. Family Member #1 said Patient #2 was suctioned at birth. At approximately 5 to 8 minutes after birth the 2nd Agar was completed, Patient #2 was gurgling (audible noises due to secretions in the airway) and Family Member #1 requested that Patient #2 be suctioned. Nurse #1 reached over Patient #2 from behind and suctioned Patient #2 without ever looking at and assessing the front of Patient #2's mouth and nose.

Family Member #1 said Patient #2 airways sounded junky and after the second suctioning Patient #2 had excessive drooling (which can indicate a structural abnormality fistula (connection) between the esophagus and trachea). Patient #1 and Family Member #1 were given a towel for Patient #2's drooling, but no one assessed Patient #2. Patient #1 and Family Member #1 said Nurse #1 stayed by the foot of the bed and was busy with Patient #1's (postpartum- after delivery) bleeding, they said a staff member offered to assist Nurse #1 with the care and Nurse #1 declined to be assisted with the care needs of the patients.

Patient #1 said after 5:09 A.M., when he/she had skin to skin contact, Nurse #1 took Patient #1's right breast and put it in Patient #2's mouth. Patient #1 said this was his/her first baby and Nurse #1 did not give him/her any education or guidance with breast feeding or positioning of Patient #2's face and head.

Patient #1 said Patient #2 would only take 3 suckles of his/her breast and then face planted into Patient #1 just above his/her breast. Patient #1 said he/she was concerned with Patient #2's head and face position, when Patient #2 face planted into his/her chest and Patient #1 asked Nurse #1 if Patient #2's head and face position (with the face planting) was alright. Patient #1 said Nurse #1 told her if Patient #2 can't breath, then Patient #2 will move his/her head; however, Nurse #1 did not assess Patient #2's face to address Patient #1's concern.

Patient #1 said that he/she voiced his/her concern to Nurse #1 for the second time his/her concern for Patient #2 and said words to the effect, Are you sure (Patient #2) is OK? Nurse #1 told Patient #1 and Family Member #1 that Patient #2 was fine. Patient #1 and Family Member #1 said they were concerned because Nurse #1 did not assess Patient #2 when Patient #1 asked Nurse #1 about Patient #2's head and face position. Nurse #1 was in and out of the room, or at the foot of the bed because Patient #1 had significant bleeding and was not assessing Patient #2.

Patient #1 and Family Member #1 said that at 6:00 A.M. on 7/27/18, when Patient #1 lifted Patient #2's head off of his/her chest to look at Patient #2's face, he/she saw dried blood and bleeding from Patient #2's nose and Patient #2's arm was floppy (no muscle tone). Patient #1 rang the call bell and Nurse #1 took Patient #2 right out of the room.

The Nurses Progress Note, dated 7/27/18 at 6:00 A.M. indicated that 1 hour and 50 minutes after birth, Patient #2 was limp, pale and had a respiratory and cardiac arrest, resuscitative measures were started. At 6:03 A.M., Patient #2's heart rate returned, greater than 60 beats (abnormally low) but still no respiratory effort, then at 6:08 A.M. heart rate 133, oxygen saturation 79% to 100 % (amount of oxygen in the blood, normal greater than 90%) with agonal breathing (gasping labored respirations, an abnormal pattern of breathing brain stem reflex) and mottling (blotchy red-purplish skin, when the heart cannot adequately pump blood effectively). The Neonatal Intensive Care Unit Ambulance was called and transported Patient #2 to a tertiary Hospital.

The Tertiary Hospital Discharge/Transfer Note, dated 8/2/18, indicated Patient #2 was on a ventilator due to respiratory failure and had seizures. After several days of intensive treatment and life sustaining interventions, the Family reviewed the evidence and information with the physicians and it was decided on withdrawal of life support. The cause of death was Neonatal Encephalopathy, probable hypoxic ischemia (brain injury caused by a lack of oxygen risk blood to the newborn's brain), based on the MRI (a diagnostic imaging test) with the attributing causes; acute respiratory failure and seizures.

The Surveyor interviewed Nurse #1 at 11:07 A.M. on 1/16/19 Nurse #1 said she was assigned to take care of both Patient #1 and Patient #2, even though she was very busy with Patient #1 due to her bleeding. Nurse #1 said it was usual practice on the 11:00 P.M. to 7:00 A.M. shift for one nurse to be assigned two patients, both the Newborn and a Mom, immediately after delivery.

According to the American Pediatric Associations the Facility's Standards of Practice Nursing, staff assigned to the delivery and immediate recovery of a woman should have no other obligations.

Nurse #1 was interviewed and said that Family Member #1 had requested that Patient #2 be suctioned again after the 2nd Apgar score (taken 5 minutes after birth). Nurse #1 said Patient #2 was not gurgly and, words to the effect of, our new standard of care is to use less intervention to allow the baby clear their own airway.

Nurse #1 was interviewed and said Patient #2 was drooling small amounts but that drooling after delivery was normal. When asked what can cause excessive drooling, Nurse #1 did not know and said drooling was not an issue and the newborns typically clear their own secretions.

Nurse #1 was interviewed and said she did not document that she had provided breast feeding education to Patient #1. Nurse #1 said after 5:00 A.M. on 7/27/18 when she had Patient #1 take Patient #2 to his/her breast, Patient #1 asked, can Patient #2 breathe? Nurse #1 said most newborns will move their head if they can't breathe, but Nurse #1 did not assess Patient #2 at that time or after Patient #1 had questions about Patient #2's head and face position during the skin to skin contact.

Nurse #1 was interviewed and said the nurses are being pushed to allow skin to skin contact (with the mother and newborn) and the nurses use to be able to bring the newborns to the Nursery or the warmer to assess the newborn and do a full head to toe assessment. Nurse #1 said when Patient #1 had the concern with the position of Patient #2's face, Nurse #1 did not have a view of Patient #2's face, only the back of Patient #2 because Patient #2 and Patient #1 had skin to skin contact at that time.

Nurse #1 was interviewed and said she left the newborn's room at 5:50 A.M. on 7/27/18. Patient #1 rang his/her call bell at 6:00 A.M. to tell Nurse #1 that something was wrong with Patient #2. Nurse #1 entered Patient #1's room and found Patient #2 unresponsive and blue (a sign inadequate oxygen in the blood, from a respiratory and cardiac arrest) with blood coming from Patient #2's nose.

Nurse #1 was interviewed and said she did not take Patient #2's vital signs every 30 minutes, which would have been at 5:15 A.M. and at 5:45 A.M. on 7/27/18. Nurse #1 said she did not perform Patient #2's Assessment (the Physical Examination), but that she had two hours to perform the assessment and had planned to perform the assessment at 6:05 A.M. but Patient #2 had a respiratory and cardiac arrest at 6:00 A.M.

Nurse #1 was interviewed and said she should have requested assistance because she was taking care of both Patient #1 and Patient #2 immediately after delivery, which delayed progress with performing the Newborn Admission Assessment (Physical Examination) and Patient #2's every 30 minute vital signs.

B. The Surveyor interviewed the Director of the Maternal Child Health (MCH) Unit at 9:00 A.M. on 1/16/19. The Director of the MCH Unit said that after delivery, the staffing ratio is normally 1 to 1, which is one nurse for the mother and another nurse for the newborn. The Director of the MCH Unit said the Hospital follows the Guidelines for Perinatal Care, American Academy of Pediatrics guidelines. According to these guidelines, staff assigned to the delivery and to the immediate recovery of a woman should have no other obligations.

The Director of the MCH said that on 7/27/18, Nurse #1 was assigned to take care of both Patient #2 and Obstetric Patient #1 (1 to 2 staffing), and this is not their usual staffing practice.

The Surveyor interviewed Nurse #1 at 11:07 A.M. on 1/16/19. Nurse #1 said she was assigned to take care of both Obstetric Patient #1 and Patient #2 even though she was very busy with Obstetric Patient #1 due to her postpartum bleeding.

The Surveyor interviewed Nurse #2 at 2:45 P.M. on 1/18/19. Nurse #2 said that on the 11:00 P.M. to 7:00 A.M. shift staff usually try to keep the newborn with the mother, if the newborn is healthy and if the mother does not need a break. Nurse #2 said on 7/27/18, the usual practice for staffing Registered Nurses on the MCH Unit was dual care, one nurse for both one mother and one newborn (1 to 2 staffing) on the 11:00 P.M. to 7:00 A.M. shift.

C. The Physician's Admission Note for Patient #4 (a newborn), dated 4/26/18, indicated Patient #4's, date of birth was 4/26/18 at 1:52 P.M., a 35-week-old premie (born before 37 weeks), born via an emergent C-section, diagnosed with acute respiratory distress, hypoxemia and anemia. The first set of vital signs were taken at 3:10 P.M., which is one hour and 18 minutes after birth, the 2nd set of vital signs was taken at 3:20 P.M., and the 3rd set of vital signs were not taken again until 4:30 P.M., which is one hour and 10 minutes later. Vital signs were not taken every 30 minutes for two hours after birth as per the Hospital Policy. Newborn #4 was transferred to a tertiary Hospital on 4/26/18 at 8:15 P.M.

The Physician's Admission Note for Patient #5 (a newborn), dated 9/22/18, indicated Patient #5's, date of birth was 7/12/18 at 3:10 A.M., a 40-week (full term) Newborn, born via an emergent C-section for deceleration (a decrease) of the fetal heart rate. Patient #5 was born blue without spontaneous breathing given positive pressure ventilation (ventilation of every breath is supported with positive pressure) and intubated with improvements in heart rate and oxygen saturations. After the full set of vital signs were performed at 4:00 P.M., the subsequent two sets of vital signs, taken at 4:30 P.M. and 5:00 P.M., did not include temperatures to monitor for infection or hypothermia (as required).

The Physician's Admission Note for Patient #9 (a newborn), dated 1/15/19, indicated Patient #9's, date of birth was 1/15/19 at 9:12 P.M., a 40-week Newborn, born via a spontaneous vaginal delivery. After the second set of vital signs were taken at 9:45 P.M. the next two required vital signs which should have been taken at 10:15 P.M. and 10:45 P.M. were not taken. The next vital signs were not performed until 11:15 P.M., two hours later.

NURSING CARE PLAN

Tag No.: A0396

Based on records reviewed and interviews, the Hospital failed for one (Patient #1) of one sampled patient to follow the care plan and standards of practice to monitor and document intake and output, related to actual blood loss to determine the patient's replacement needs and assist in early detection of hypovolemic shock (a life-threatening condition).

Findings include:

The Hospital's practice guideline, indicated the American College of Obstetrics and Gynecologist (ACOG) defined postpartum hemorrhage as cumulative (total) blood loss (intrapartum (during delivery) and postpartum (after delivery) of 1,000 milliters (ml) or greater or blood loss accompanied by signs and symptoms of hypovolemia within 24 hours after cesarean or vaginal delivery.

The Hospital policy titled Obstetric Hemorrhage, dated 6/2016, indicated this was the guideline for staff regarding the assessment and interventions required for women experiencing an obstetric hemorrhage. Obstetrical hemorrhage is defined as 10% decrease in hematocrit (a later sign) greater than 500 milliliters (ml) blood loss for vaginal delivery and greater than 1000 ml for C-section or a need for a transfusion. (There was not specific guidance with routine deliveries (such as quantitative blood loss) only if the Obstetric Patient had placenta problems or a bleeding disorder)

The Staff Nurse job description, dated 10/2017, indicated that for professional practice the nurse adheres to policies, procedures and standards of care.

The Face Sheet, dated 7/26/18, indicated Patient #1 was admitted on 7/26/18, to rule out labor at 40 weeks pregnant (full-term).

Patient #1's Labor and Delivery plan had an intervention to monitor intake and output.

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

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

The Obstetrics Delivery Note, dated 7/27/18 at 4:39 A.M., indicated Patient #1's estimated blood loss for the delivery (childbirth) was 250 ml.

The Maternity Recovery Room Record (after childbirth) for Patient #1 (included Intake and Output records), undated, authored by Nurse #1, indicated at 4:10 A.M. (on 7/27/18) a live newborn was delivered vaginally.

The narrative documentation included the following observations of the vaginal blood loss with no documentation of the quantitative blood loss:

At 5:20 A.M., there was a large gush of blood and the Obstetrician was notified and Methergine (a medication to control bleeding after childbirth) was administered.

At 5:40 A.M., there was a large plum size clot noted (in the vaginal blood).

At 6:20 A.M., there was a large gush, the Obstetrician was notified and Hemabate (a medication to treat bleeding after childbirth due the uterus failing to contract) was administered.

The Surveyor interviewed Nurse #1 at 11:07 A.M. on 1/16/19. Nurse #1 said she was assigned to take care of Patient #1 during labor and delivery and post-delivery and was concerned at 5:20 A.M. with the amount of vaginal blood flow, when Obstetric Patient #1 had a large gush.

Nurse #1 said she did not weigh the blood-soaked pads or linen, and said words to the effect of, she only estimates the blood loss, unless the patient was symptomatic, or the physician called it a hemorrhage.

Nurse #1 did not quantify the blood loss during delivery or after delivery for early detection of an obstetrical hemorrhage, the standard of practice is quantitative blood loss (weighing or measuring the blood or blood-soaked pads/linen) to determine the actual blood loss.

The Surveyor interviewed the Director of the Maternal Child Health (MCH) Unit on at 9:00 A.M. on 1/15/19. The Director of the MCH Unit said that during delivery and post-delivery, if the staff can weigh the blood loss it should be quantified not estimated (for the early detection and treatment of an obstetrical hemorrhage).

PATIENT CARE ASSIGNMENTS

Tag No.: A0397

Based on records reviewed and interviews, the Hospital failed for one (Nurse #1) of five personnel files reviewed to ensure the Nurse's performance and competency were evaluated annually with the required performance appraisal.

Findings include:

The Hospital Policy, Performance Appraisals, dated 9/25/1997, indicated that Supervisors with input from the employee, peers and/or internal or external customers will evaluate their employee's performance. Performance appraisals shall be completed on each anniversary of their current position. Reviews should be completed around the employees review date and are considered overdue beyond 30 days following the due dated of the appraisal.

Nurse #1's personnel record did not have an annual performance appraisal (due 10/11/18), her last appraisal was approximately 15 months ago on 10/11/17.

The Surveyor interviewed the Human Resource Manager at 2:45 P.M. on 1/15/19. The Human Resource Manager said although Nurse #1 was still employed by the Hospital, her annual performance appraisal was not completed as required by the Hospital.