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Based on interview, record review, and facility document review, the facility failed to ensure the Condition of Participation for Nursing Services was met by failing to do the following:

1. The facility failed to ensure that the physician (Physician A) was promptly notified of poor fetal heart rate readings, when Patient A was in labor. These failed practices potentially led to the death of a full term infant, Patient B., (refer to A395);

2. The facility failed to ensure that a pain assessment and interventions were implemented for Patient 103, (refer to A395);

3. The facility failed to ensure a fall assessment and care plan were implemented for pediatric patients per the facility's P&P's for Patients 105 and 404, (refer to A395);

4. The facility failed to ensure the L&D central and outpatient logs were completed per the facility P&P's, (refer to A395);

5. The facility failed to ensure that the risk factors for hyperbilirubinemia (excessive bilirubin in the blood, which may lead to jaundice,) were identified as outlined in the facility P&P's for Patient 503, (refer to A395);

6. The facility failed to ensure their P&P's related to the assessment and treatment of pressure ulcers were implemented for Patient 102, (refer to A396);

7. The facility failed to ensure that their P&P's for care planning, and guidelines of care for the Women's Center were identified and implemented, Patient 509, (refer to A396).

The cumulative effect of these systemic practices resulted in the failure of the facility to comply with the Federal regulations for the Condition of Participation: Nursing Services and the failure to provide quality patient care in the facility.

Based on observation, interview, and record review, the facility failed to ensure that a registered nurse supervised and evaluated nursing care for seven of 75 patients, (Patients A, B, 103, 105, 404, 511, and 503) by failing to do the following:

1. For Patient A and B, the facility failed to immediately notify the physician when there was not a good reading of the fetal heart rate (FHR) on Patient A. These failed practices potentially contributed to the subsequent death of Patient B, a full term infant.

2. For Patient 103, the facility failed to ensure that a pain assessment and appropriate interventions were implemented, which had the potential for the patient to experience increased pain.

3. For Patients 105 and 404, the facility failed to perform a fall assessment and implement a care plan per their P&P which placed both patients at risk for falls.

4. For Patient 511, the facility failed to ensure the L&D central and outpatient logs were completed and identified Patient 511 as outlined in the facility P&P's.

5. For Patient 503, the facility failed to ensure that the risk factors for hyperbilirubinemia were identified as outlined in the facility P&P's, which had the potential for an elevated level to go undetected.

These failed practices had the potential for negative patient outcomes, including the development of hyperbilirubinemia, which in severe cases can lead to respiratory failure, brain damage, or death.
Findings:

1. Review of Patient A's record was conducted on May 3, 2010. The "Assessment, Labor & Recovery Flow Sheet," dated April 19, 2010, indicated Patient A was admitted to the facility on April 19, 2010, at 1:30 a.m. At 1:35 a.m., by RN-A documented, "MD (Physician A,) called on cell, notified of pt complaints... VC's (contractions) q 2-3 min, SVE (vaginal exam), FHR 120's, difficult to trace R/T (related to) maternal size..."

At 1:50 a.m., RN-A documented that report was given to RN-B.

At 2:03 a.m., RN-B the FHR was "105-110 bpm with weak sono signal (the signal that transmits the fetal heart sounds and rate) noted. pt. turned to L side & searching for FHR...0204... FHR audible @ 105-110 bpm, difficult to trace FHR due to mother's obese abdomen...2:10 a.m. FHR audible at 105 with audible decel (decrease in the FHR,) noted...0215 (2:15 a.m.)..explained to mother having difficult keeping FHR on monitor, but I can hear it @ 95-105 bpm. noted.... pt. turned to supine position with R (right) tilt."

At 2:21 a.m., the record indicated, "holding sono & tracing FHR @ 85-105 bpm. 0224 (2:24 a.m.) O2 placed via mask at 10L/min"

The physician was not notified of the difficulty monitoring the fetal heart until 2:25 a.m. (50 minutes later). RN-B documented at 2:25 a.m. "(MD) notified of difficulty maintaining FHR tracing with sono (sonogram/x-ray,)" and will attempt FSE (fetal scalp electrode-an electrode placed on the baby's scalp to track the baby's heartrate) placement, order rcvd (received) for FSE placement, 0229 (2:29 a.m.) failed attempt @ FSE placement."

Review of the "Nursing Progress Notes Continuation Sheet," dated April 19, 2010, at 2:25 a.m., indicated, "late entry... (MD,) notified to come to pts. bedside for evaluation." The notes at 2:38 a.m., indicated, "Called (physician) for STAT (immediately,) C-Section for Fetal Bradycardia (slow heart rate)." The notes at 2:43 a.m. indicated, "Transferred to OR via pt. bed in hand and knee position, draped by a blanket. Transferred to OR bed..Unable to assess baseline (FHR,) heavy artifact." The note at 2:55 a.m. indicated, "Incision by MD,"

On April 19, 2010, at 2:57 a.m., the notes indicated, "Baby Delivered with no Respiratory effort, No Heartrate, Pale Colour, No muscle Tone noted, Resuscitation efforts started, 0300 (3 a.m.) Code White (cardiac arrest,) Called." At 3:33 a.m. the physician, "Ceased Resuscitation efforts."

Review of the "Delivery Room Register," dated April 19, 2010, indicated Patient A had a cesarean section for a, "Pre-op DX (diagnosis,) Fetal Bradycardia, Non-reassuring FHR....Post op DX IVFD (in-vitro fetal death)."

Review of the facility policy, "Fetal & Uterine Monitoring Assessment, Interpretation, & Documentation," revised "8/08," was conducted on May 12, 2010. The policy indicated, "If the baseline FHR is less than 110 bpm, it is termed bradycardia ..."

Review of the facility P&P, "Position Title: Clinical RN, Labor and Delivery," revised "10/31/2008," was conducted. The "Unit Specific Competencies Labor and Delivery," indicated, "...initiate appropriate nursing interventions for non-reassuring fetal heart rate patterns (FHR which can be associated with adverse neonatal outcomes related to a lack of oxygen)...per hospital policy and procedure."

An interview was conducted with RN B on May 3, 2010, at 3:15 p.m. RN B stated, "I came to the patients room (Patient A,) at 1:55 a.m. I was the charge nurse that evening. (RN A) gave me an S-BAR report (formal method of communication between healthcare practitioners). I began the admission assessment and I realized that the FHR wasn't tracing and was on the low end of normal. I audibly heard the FHR between 105 and 110 when I completed the admission assessment, and I was still having difficulty getting it to trace. I did not attempt to get another machine nor did I call anyone at that time." She stated that she did not call the doctor and notify him of the non-reassuring fetal heart rate and the difficulty monitoring it until 2:25 a.m. She stated that she did not put oxygen on the patient until 2:24 a.m. "I didn't put the oxygen on earlier because I didn't have an accurate assessment. I wasn't assured that the baby was O.K. I didn't have enough of a continuous tracing."

An interview was conducted with the PNE (perinatal educator-to include the period shortly before and after birth,) on May 3, 2010, at 9:30 a.m. The PNE stated the physician should have been called when the FHR was difficult to establish.

Review of the facility policy, "Fetal & Uterine Monitoring Assessment, Interpretation, & Documentation," was conducted on May 12, 2010. The policy indicated, "To provide an evaluation of the fetal heart rate FHR response to labor and birth, to assist in monitoring quality of labor, and to describe interventions aimed at maximizing fetal perfusion and oxygenation."

The procedure indicated, "...non-reassuring patterns can be associated with adverse neonatal outcomes related to hypoxia (lack of oxygen) and because the clinician is unable to predict which fetuses may be affected, non-reassuring FHR patterns require careful evaluation and timely intervention."

"If the FHR pattern is non-reassuring, interventions along with the maternal-fetal response to the interventions should be documented...The goals of intervention include maximizing both uteroplacental and umbilical blood flow and gas exchange, therefore interventions are implemented toward those ends and include but are not limited to: ...Administer oxygen by non-rebreather facemask at 10 liters per min...Primary care physician is to be notified of abnormal FHR patterns in a timely manner."

An interview was conducted with the CLRN (clinical lead registered nurse,) on May 12, 2010, at 10:15 a.m. The CLRN stated after reviewing Patient A's fetal monitoring strip, dated April 19, 2010, originating at 1:30 a.m., "The purpose of the fetal monitoring strip is to check fetal well being and to check if the baseline (the FHR during a 10 minute segment) is normal. A normal FHR ranges from 110-160, this (Patient A's) tracing indicates a signal loss, it is hard to establish a FHR, I would not feel comfortable saying what the rate was, I would call the MD."

Review of the facility policy, "Admission Assessment Of The Labor Patient," revised, "8/08,"was conducted. The policy indicated, "The responsible obstetric provider should be informed promptly (within 30 minutes of assessment) of the patient's arrival.The nurse calling the provider should describe the patient's current situation...current Assessment of both mother and fetus...In addition the provider shall be informed of any real or potential complications including but not limited to: Non-reassuring fetal heart rate."

An interview was conducted with Patient A's Physician, Physician A, on May 4, 2010, at 3:50 p.m. When questioned regarding situations in which he would expect a call from the L&D nurses Physician A stated, he would expect a call when the patient has their initial evaluation upon arrival, then after a follow-up cervical exam and also if anything unusual occurs, such as an episode of bradycardia. Physician A further stated that the nurses called to notify him of (Patient A's) arrival, then called back one hour later.


2. An interview was conducted with Patient 103 on June 14, 2010, at 3 p.m. Patient 103 stated she came to the emergency room with chest pain and was admitted. Patient 103 also stated she was in a lot of pain yesterday, and she had a difficult time getting the nurses to respond to her pain.

A review of Patient 103's record was conducted on June 14, 2010. Patient 103 was admitted to the facility on June 11, 2010, with a diagnosis of moderate inferior wall myocardial infarction (heart attack.)

A review of the "Patient Care Flow Sheet," dated June 13, 2010, indicated Patient 103 had an acceptable pain rating score of, "4/10," (based on a pain scale of 1-10 with 10 being the highest intensity of pain.) At 8 p.m., 9 p.m., and 10 p.m., the patient's pain scale was indicated as, "7/10."

"Pain Interventions," included medication, positioning, or non-pharmacologic (medication) interventions. During this three hour period there were no "Pain Interventions," documented as having been implemented for Patient 103.

A review of the P&P, "Assessment/Reassessment Of Patient," was conducted on June 14, 2010. The policy indicated, "Pain Assessment includes: Initial pain screen on all patients regarding description, and location of pain, how pain has been managed, scoring of pain intensity, and patient's acceptable level of pain."

An interview was conducted with NM 4 on June 14, 2010, at 3:20 p.m. NM 4 stated the goal is to maintain the patient at the acceptable pain level the patient states. The NM acknowledged that no pain interventions were documented.

An interview was conducted with CN 2 on June 14, 2010, at 3:30 p.m. CN 2 stated the nurses are supposed to talk to the patient about relaxation techniques and other non-pharmacological (medication) interventions, this is to be documented in the patient's chart.





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3. On June 15, 2010, at 10 a.m., a tour of the east medical/surgical unit was conducted. The records for two pediatric patients, (Patients 404 and 105,) were reviewed.

Patient 404 was a four year old, admitted June 14, 2010, with a diagnosis of closed head trauma (CHT). Patient 404 fell down three to four stairs at home, experienced a loss of consciousness, nausea, vomiting, and a contusion to the left anterior skull. The record did not indicate a fall assessment.

An "Interdisciplinary Plan of Care," titled, "Impaired Physical/Activity Intolerance", was reviewed. The care plan in Patient 404's record was blank.

Patient 105 was a 10 year old male, admitted on June 14, 2010, with a diagnosis of exploratory laparotomy (abdominal surgery,) and appendectomy. The record did not include a fall risk assessment.

On June 15, 2010, at 10:15 a.m., CN 1 was interviewed. CN 1 stated, "We assess adults, not kids for fall risk."

On June 15, 2010, at 10:30 a.m., RN 1 was interviewed. RN 1 stated, "The fall protocol is to put a fall risk sign at the door and to put a yellow band on the patient. We do not do pediatric fall assessments."

On June 15, 2010, the facility P&P, "Patient Fall Prevention Program", was reviewed. The purpose indicated, "...To maximize patient safety and to minimize patient injury, to self and others."

The policy indicated, "Each patient will be assessed according to our Fall Prevention Program by a licensed RN on admission, to maximize the risk of patient injury to self and others. We will maximize patient safety and minimize patient injury, through the implementation of the Fall Prevention Program."

The procedure indicated, "Assessment: This is to be completed by the RN on the nursing flow record...Screening-High Risk for Fall (Two or more checks is criteria for High Risk), Previous Fall, Mobility Problem, Confusion (constant/intermittent) Head Injury ...Identify the patient at high risk (having at least 2 checks) and: Apply a yellow "fall risk" wristband to the patient during the admission process. Place a yellow fall precautions sign on the patient's door ..."

"Documentation ... A. The High Risk for Falls criteria checklist is to be completed initially on every hospital admission and every twelve (12) hours. Document in the nursing notes:
1. Open the problem: Impaired Physical Mobility/Activity Intolerance on the Inter-Disciplinary Plan of Care (IPOC) ...
2. Document the behavior data/reorientation and the frequency of patient monitoring.
3. Document patient/family teaching.
4. Document all other interventions provided including patient response to interventions."

Patient 404 had two of the indicated risk factors, a previous fall and a head injury, which classified the patient as high risk for falls.

On June 15, 2010, at 10:20 a.m., Patient 404 was observed lying in bed. There was no fall risk sign at the doorway. Patient 404 was wearing a white identification band on her right ankle. There was no yellow identification band indicating she was at risk for falls.

On June 15, 2010, at 10:45 a.m., NM 4 was interviewed. NM 4 stated, "A yellow band should have been placed on Patient 404 at the time of admission by the nurse.






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4. On June 14, 2010, at 10:35 a.m., a tour of the L&D and Couplet Care units was conducted.

A review of the "Labor & Delivery Central Log" indicated Patient 511 arrived at the facility on June 12, 2010, at 11:15 p.m., for the treatment of left leg pain and swelling. The log contained no disposition, or date and time of disposition for Patient 511.

A review of the "Labor & Delivery Outpatient Register" indicated Patient 511 had not been entered into the register for June 12, 2010, or June 13, 2010.

A review of the "Labor & Delivery Delivery Room Register" indicated Patient 511 had not been entered into the register for June 12, 2010 or June 13, 2010.

An interview was conducted with CN 5, OBM 2, and the PNE on June 14, 2010, at 11 a.m. They stated all nurses put the patient information in the logs/register and the CN makes sure the information was complete.

During an interview with the DWS, NM 1, and the PNE, on June 15, 2010, at 11 a.m., they reviewed the logs and were unable to find documentation of a date, time, and disposition of Patient 511 in the "Labor & Delivery Central Log" and Patient 511 was not entered into the "Labor & Delivery Outpatient Register" as an outpatient or "Labor & Delivery Delivery Room Register" as a delivery.

A review of Patient 511's record was conducted on June 15, 2010. Patient 511 was seen as an outpatient on June 12, 2010, at 11:12 p.m., with a pregnancy due date of September 29, 2010, history of thrombophlebitis (blood clot in vein), and current complaint of left leg pain and swelling. Patient 511 was discharged to home on June 13, 2010, at 7:34 a.m.

The facility P&P titled, "Initial Obstetrics Intake" dated May 13, 2010, indicated "... Document in the L/D Central Log all patients who present to L/D for evaluation."

The facility P&P titled, "Perinatal Medical Screening Exam" dated June 2009, indicated " ... Documentation: ... Enter patient data, including disposition (admitted, discharged, transferred, refused treatment), into the Labor and Delivery Outpatients Logbook. ..."

5. A review of the records for Patient 504 and Newborn 503 was conducted on June 16, 2010. Patient 504 was admitted to the facility on May 21, 2010, for observation of preterm labor.

The "Labor and Delivery Summary" indicated an EDC of June 19, 2010 and a gestational age of 36 5/7 weeks. Newborn 503 was born on May 21, 2010, at 5:56 p.m., by primary cesarean section for breech presentation (buttocks presenting at vaginal opening) and fetal distress.

The "Hour Specific Bilirubin Nomogram (chart indicating an alignment of specific values)" dated May 21, 2010, for Newborn 503 was reviewed and indicated six risk factors for newborn hyperbilirubinemia (excessive bilirubin in the blood, which can lead to brain damage, respiratory failure and death):
- Positive Coombs (test used to evaluate anemia and blood disease in a newborn);
- G6PD deficiency (error in metabolism causing anemia);
- Five min(ute) Apgar less than 7;
- Temperature Instability;
- Treatment of sepsis (infection); and
- 35-37 6/7 wks gestation.

The "Hour Specific Bilirubin Nomogram," and "Newborn Admit Flowsheet," dated May 21, 2010, indicated Newborn 503 did not have risk factors for hyperbilirubinemia even though the gestational age for Newborn 503 was 36 5/7 weeks. A TcB was not obtained for Newborn 503.

During an interview with the DWS, on June 16, 2010, at 4 p.m., she reviewed the clinical record and was unable to find documentation of a risk factor for hyperbilirubinemia even though the gestational age for Newborn 503 was 36 5/7 weeks.

The facility policy and procedure titled "Hyperbilirubinemia, Assessment, Identification, and Intervention" dated April 2010, indicated "... On Nursery Initial Admission Assessment a. Assess for both jaundice and the following risk factors and document these on the Hour Specific Nomogram Table ... 35-37 6/7 weeks gestation b. Obtain a TcB ... if there is visible jaundice and/or with any of these risk factors."

Based on interview, record review and facility P&P review, the facility failed to ensure that nursing staff developed and implement care plans for two of 75 patients, (Patients 102 and Newborn 509).

1. For Patient 102, the facility failed to develop and implement a care plan for wound care for the patient's decubitus ulcers.

2. For Patient 509, the facility failed to develop and implement care plans for risk factors associated with the baby's birth due to an infection and large size.

These failed practices led to a lack of communication between the nursing staff regarding these patient's specific, individualized care needs with the potential to adversely impact their overall medical status.

Findings:

1. A review of Patient 102's record was conducted on June 14, 2010. Patient 102 was admitted to the facility on June 7, 2010, with diagnoses of a left axillary (under the arm,) mass, and a necrotic (blackened,) left great toe.

On June 11, 2010, two photographs were taken of Stage II pressure ulcers, (also known as bed sores,) located on Patient 102's upper and middle left buttocks, measuring 2.5 cm x 3.25 cm, and 1.5 cm x 1.1 cm, respectively. According to the National Pressure Ulcer Advisory Panel, a Stage II pressure ulcer is a, "Partial thickness loss of dermis (skin) presenting as a shallow open ulcer with a red pink wound bed, without slough."

An interview was conducted with Patient 102's primary nurse, RN 5, on June 14, 2010, at 11 a.m. RN 5 stated, if a patient has a pressure ulcer it would be put in the care plan. RN 5 further stated she was not aware that the patient (Patient 102,) had a pressure ulcer, and did not see a care plan for the pressure ulcer.-*

A review of the facility P&P, "Care Planning, Patient," revised "12/09," was conducted on June 14, 2010. The purpose indicated, "To provide the interdisciplinary healthcare team with guidelines for developing and prioritizing an individualized patient care plan."

The policy indicated, "The patient's care plan shall be revised/updated to reflect changes in patient status, as evaluated and assessed by the Registered Nurse and other members of the healthcare team."

An interview was conducted with Patient 102 on June 14, 2010, at 2:15 p.m. Patient 102 stated, "I have bed sores on my bottom because I was not able to move much at home before I was admitted to the facility. The staff has not been applying any dressings to my bed sores."

A review of the facility's P&P, "Wound Care-Prevention, Staging, and Treatment of Pressure Ulcers," revised "7?09," was conducted on June 14, 2010. The purpose indicated, "To provide guidelines for assessment, staging, interventions, and documentation of patients with actual or potential skin breakdown."

The procedure indicated, "The objective of treatment is to cover, protect, hydrate, insulate, absorb, cleanse, prevent infection and promote granulation...Stage 11 Ulcers: Cleanse with normal saline or wound cleanser. Apply transparent dressing or hydrocolloid wafer every 3 days or as needed..."

An interview was conducted with NM 3 on June 14, 2010, at 2:20 p.m. NM 3 stated, "The primary nurse oversees the wound care. I would expect to see that a transparent dressing or a hydrocolloid wafer (specialized dressing,) were used."

Further record review failed to show that a care plan was developed and implemented or dressings were used to treat Patient 102's two pressure ulcers per the facility's P&P's.





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2. A review of Newborn 509's record was conducted on June 15, 2010. Newborn 509 was admitted to the facility on June 15, 2010.

The "Physician's Record of Newborn Infant," dated June 15, 2010, indicated pertinent history of being large for gestational age (LGA) and positive maternal group beta streptococcus infection (GBS) which was treated with one dose of antibiotic. The physician's documentation indicated term LGA female with inadequately treated GBS.

The "Nursery Interdisciplinary Plan of Care," (not dated,) indicated the plan of care for "Alteration in Infection: + GBS mother" and "Alteration in Hypoglycemia/Hyperglycemia (low blood sugar/high blood sugar): LGA" were not initiated for Newborn 509.

During an interview with NM 1, on June 15, 2010, at 10:20 a.m., she reviewed the record for Newborn 509 and was unable to find documentation of the interdisciplinary plans of care addressing the basic assessment of LGA and positive maternal GBS. She further stated interdisciplinary plans of care should have been initiated for alteration in infection and alteration in hypoglycemia/hyperglycemia based on the history and assessment.

The facility P&P titled "Care Planning, Patient" dated December 2009, indicated "... Each patient's care plan shall be guided by the following elements of the nursing process: Basic Assessment ... Patient Care Plan ..."

The facility P&P titled "Guidelines of Care, Women's Center" dated May 2010, indicated "... These guidelines of care will include the expected goals, assessment (data collected) and interventions and shall be performed on admission and during routine care. ..."

Based on interview and document review, the facility failed:

1. For eight of 75 patients (Patients 311, 209, 210, 211, 212, 517, 501, 502), to ensure the medical staff documented an accurate discharge risk assessment for hyperbilirubinemia (excessive bilirubin in the blood), according to the American Academy of Pediatrics guidelines;

2. To ensure six of 75 patients (Patients 502, 504, 507, 205, 109, and 110,) had physician's orders for c-sections;

3. To ensure Patient 510 had a physician's order for an epidural anesthetic.

Findings:

1a. On June 16, 2010, at 2:00 p.m., a review of Newborn 311's record was conducted. Newborn 311 was born on April 4, 2010. Review of, "OSHPD Ethnicity/Race Form Newborn," indicated "[C] Asian" was circled and the newborn's mother signed the form. On the bottom right corner of the form, a box titled patient label indicated "C" was written in the box.

Newborn 311's record indicated, "Discharge Examination: Describe Abnormal Findings, Impressions & Discharge Diagnosis." At the bottom of the form under the section titled, "Hyperbilirubinemia Discharge Risk Assessment," a box is marked with an X next to "no risk factors."

Below that, the form lists 9 major risk factors, "Predischarge TSB/TcB in the high risk zone, east Asian race, blood group incompatibility with + Coombs or other known hemolytic disease (e.g. G6PD), previous sibling with jaundice (yellowing of the skin,) or received phototherapy, cephalhematoma or bruising, jaundice in the first 24 hours, gestational age 35-37 wk, jaundice observed before discharge, inadequate nutrition/hydration."

The box next to "East Asian race" was not marked. The form was signed by the physician however there was no time or date documented. A document titled "physician orders" indicated the physician ordered discharge home with mom, follow up in 1 week.

An interview with the OBM was conducted on June 16, 2010. The OBM acknowledged that the physician did not include Asian race as a major risk factor on the discharge examination form.



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1b. On June 16, 2010, the records of Patient 209 and Newborn 210 were reviewed. Patient 209 was admitted for labor and delivery on May 3, 2010. Patient 209 delivered her baby (Newborn 210,) on May 3, 2010, at 1:05 p.m.

The form titled, "OSHPD Ethnicity/Race Form" indicated Patient 209 was "Asian."

Newborn 210's record titled, "Hour Specific Bilirubin Nomogram" was reviewed and indicated six risk factors for hyperbilirubinemia:
- Positive Coombs;
- G6PD deficiency;
- Five min(ute) Apgar less than 7;
- Temperature Instability;
- Treatment for sepsis; and,
- 35-37 6/7 wks gestation.

The document indicated Newborn 210 did not have any risk factors for hyperbilirubinemia.

Newborn 210's "Physician's Record of Newborn Infant" dated May 5, 2010, at 8:30 a.m., included the physician's discharge risk assessment for hyperbilirubinemia. The physician identified "jaundice observed before discharge" as a risk factor. The section for "East Asian race" was not marked as a risk factor.


1c. On June 16, 2010, the records of Patient 211 and Newborn 212 were reviewed. Patient 211 was admitted for labor and delivery on May 3, 2010. The patient delivered her baby (Newborn 212) on May 4, 2010 at 2:22 a.m. Patient 211 age of gestation was 37 3/7 weeks.

Newborn 212's record titled, "Hour Specific Bilirubin Nomogram" was reviewed and indicated Newborn 212's risk factor for hyperbilirubinemia was 35-37 6/7 weeks gestational age.

Newborn 212's "Physician's Record of Newborn Infant" dated May 6, 2010, at 8 a.m., included the physician's discharge risk assessment for hyperbilirubinemia. The physician identified "jaundice observed before discharge" as a risk factor. The section for "Gestational age 35-37 6/7 wk" was not marked as a risk factor.

On June 15, 2010, at 2:15 p.m., the DWS was interviewed. The DWS stated the facility's policy indicated only six risk factors were identified appropriate for the licensed nurses to identify. These risk factors were listed on the "Hour Specific Bilirubin Nomogram." The DWS stated the physicians were responsible to identify all risk factors for hyperbilirubinemia before discharging the newborns.

On June 15, 2010, at 11 a.m., Newborn 210 and 212's records were reviewed with NM 1. She stated the physician assessment should have indicated all risk factors for hyperbilirubinemia. She stated the facility audited the newborns' discharge assessments for hyperbilirubinemia risks, but not the accuracy of the physician's assessment.

According to AAP Guidelines, "Management of hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation 2004," the major risk factors for development of severe hyperbilirubinemia in infants of 35 or more weeks' gestation were as follows:

- Predischarge TSB or TcB in the high-risk zone;
- Jaundice observed in the first 24 hours;
- Blood group incompatibility with positive direct antiglobulin test, other known hemolytic disease (e.g. G6PD deficiency);
- Gestational age 35-36 weeks;
- Previous sibling received phototherapy;
- Cephalohematoma or significant bruising;
- Exclusive breastfeeding, particularly if nursing is not going well and weight loss is excessive; and,
- East Asian race.



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1d. On June 14, 2010, the records for Patient 517 and Newborn 508 were reviewed. Patient 517 was admitted for an induction of labor on June 12, 2010. The patient delivered her baby (Newborn 508) on June 13, 2010, at 12:33 a.m.

The "Labor and Delivery Admission Assessment" dated June 12, 2010, indicated there was a problem with a previous child as "was on bili light x1 wk (for 1 week)."

The "Hour Specific Bilirubin Nomogram" for Newborn 508 was reviewed and indicated Newborn 508 did not have any risk factors for hyperbilirubinemia.

The "Physician's Record of Newborn Infant" dated June 13, 2010, at 7:30 p.m., indicated "No Risk Factors" was marked on the hyperbilirubinemia discharge risk assessment. The section for "Previous sibling with jaundice or received phototherapy" was not marked as a risk factor.

1e. On June 16, 2010, the records for Patient 502 and Newborn 501 were reviewed. Patient 502 was admitted for a repeat cesarean section to L&D on June 13, 2010. The patient delivered her baby (Newborn 501) on June 13, 2010, at 11:58 a.m.

The "Labor and Delivery Summary" indicated an EDC of July 2, 2010, and a gestational age of 37 2/7 weeks.

The "Hour Specific Bilirubin Nomogram" for Newborn 501 was reviewed and indicated Newborn 501 did have a risk factor for hyperbilirubinemia of "35-37 6/7 wks gestation."

The "Physician's Record of Newborn Infant" dated June 14, 2010, indicated "No Risk Factors" was marked on the hyperbilirubinemia discharge risk assessment. The section for "Gestational age 35-37 6/7 wk" was not marked as a risk factor.

1f. On June 16, 2010, the records for Patient 504 and Newborn 503 were reviewed. Patient 504 was admitted to the facility on May 21, 2010, for observation of preterm labor.

The "Labor and Delivery Summary" indicated an EDC of June 19, 2010, and a gestational age of 36 5/7 weeks. Newborn 503 was born on May 21, 2010, at 5:56 p.m.

The "Hour Specific Bilirubin Nomogram" for Newborn 503 was reviewed and indicated Newborn 503 did not have risk factors for hyperbilirubinemia even though the gestational age for Newborn 503 was 36 5/7 weeks.

The "Physician's Record of Newborn Infant" dated May 21, 2010, indicated the section for "Gestational age 35-37 6/7 wk" was not marked as a risk factor on the hyperbilirubinemia discharge risk assessment.

2a. On June 16, 2010, the record for Patient 502 was reviewed. Patient 502 was admitted to the facility on June 13, 2010, for a repeat cesarean section.

The "Cesarean Section (C/S) Orders" dated June 13, 2010, at 10:55 a.m., indicated the section for type of surgical procedure to be ordered reflected three options, with a check box next to each option. The options were "Primary Cesarean Section (C/S), Repeat C/S, Add Tubal Ligation." The three check boxes were blank.

Patient 502 signed an "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures" for a "Repeat Cesarean Section with Bilateral Tubal Ligation" on June 13, 2010, at 11 a.m.

2b. On June 16, 2010, the record for Patient 504 was reviewed. Patient 504 was admitted to the facility on May 21, 2010, for observation of preterm labor.

The "Cesarean Section (C/S) Orders" dated May 21, 2010, at 4:50 p.m., indicated the section for type of surgical procedure to be ordered reflected three options, with a check box next to each option. The options were "Primary Cesarean Section (C/S), Repeat C/S, Add Tubal Ligation." The three check boxes were blank.

Patient 504 signed an "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures" for a "Primary Cesarean Section" on May 21, 2010, at 5:18 p.m.

2c. On June 16, 2010, the record for Patient 507 was reviewed. Patient 507 was admitted to the facility on June 14, 2010, for labor.

The "Cesarean Section (C/S) Orders" dated June 15, 2010, at 11:36 a.m., indicated the section for type of surgical procedure to be ordered reflected three options, with a check box next to each option. The options were "Primary Cesarean Section (C/S), Repeat C/S, Add Tubal Ligation." The three check boxes were blank.

Patient 507 signed an "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures" for a "Primary Cesarean Section" on June 15, 2010, at 11:50 a.m.



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2d. On June 14, 2010, Patient 205's record was reviewed. The patient was admitted to the facility on June 13, 2010, at 4:18 a.m., for labor and delivery.

Patient 205's L&D nursing notes, dated June 13, 2010, at 1:16 p.m., indicated, "...V.O. (Verbal order) Dr. (Physician's name) for a primary cesarean section..."

Patient 205's "C-Sections Orders" were reviewed. The record contained pages 2 and 3 of the order sheets. The record did not contain page one of the three-page form.

On June 14, 2010, a blank "Page 1 of 3 C-Section Orders" was requested and reviewed. The form indicated, "Boxes must be checked to activate optional orders. Fill in appropriate blanks."

The form had sections which included, "Type of procedure" and "Pre-Op C/S Orders." The "Pre-Op C/S Orders" had sections with boxes to check indicating the patient was consenting either for Primary C/S, Repeat C/S, and/or tubal ligation.

On June 15, 2010, at 10 a.m., Patient 205's record was reviewed with the DWS. The DWS stated there should have been an order for the unplanned C/S. She stated page 1 of 3 was missing from the patient's record to indicate the C/S order.

2e. A review of Patient 109's record indicated Patient 109 was admitted to the facility on June 14, 2010. The document, "Cesarean Section (C/S) Orders," dated June 14, 2010, at 9:30 p.m. was reviewed. The section which indicated the type of surgical procedure to be ordered reflected three options, with a check box next to each option. The options were, "Primary Cesarean Section (C/S), Repeat C/S, Add Tubal Ligation." The three boxes were blank.

2f. A review of Patient 110's record indicated Patient 110 was admitted to the facility on June 13, 2010. The document, "Cesarean Section (C/S) Orders," dated June 14, 2010, at 1:21 a.m. was reviewed. The section which indicated the type of surgical procedure to be ordered reflected three options, with a check box next to each option. The options were, "Primary Cesarean Section (C/S), Repeat C/S, Add Tubal Ligation." The three boxes were blank.

Based on observation, interview and record review, it was determined the facility failed to ensure the Condition of Participation for Emergency Services was met by failing to ensure a MSE was completed in a timely manner for six OB patients. This delay in assessment could potentially lead to serious medical complications or death of both Mothers and infants. (A1104)


The cumulative effect of these systemic problems resulted in the failure of the facility's OB department to ensure quality healthcare were provide to patients who presented with Emergency Medical Conditions.

Based on interview, record review and facility P&P review, the facility failed to ensure for six of 75 patients, (Patients 112, 215, 216, 504, 506, and 505) that their policy's, "Perinatal Medical Screening Exam," and "Initial Obstetrics Intake," were implemented. These failed practices led to:

1. A delay in a MSE for Patient 112, who presented to the facility with a chief complaint of decreased FM, a symptom of potential fetal demise;
2. A one hour and 50 minute delay in a MSE for Patient 215, presenting with symptoms of active labor;
3. A one hour and 50 minute delay in a MSE for Patient 216, presenting with a chief complaint of SROM;
4. A one hour delay in a MSE for Patient 504, presenting with a chief complaint of premature regular uterine contractions;
5. A 40 minute delay in a MSE for Patient 506, presenting with a chief complaint of cramping and to rule out premature labor; and
6. A 30 minute delay in a MSE for Patient 505, presenting with a chief complaint of premature contractions with twins.


Findings:

1. A review of Patient 112's record was conducted on June 16, 2010. The "Women's Services OB Intake," form indicated Patient 112 presented to the L&D Department on May 21, 2010, at 4:15 p.m. Patient 112's EDC (estimated date of delivery) was May 27, 2010 (one week later).

The "Reason for visit," was indicated as, "Decreased FM (fetal movement)," adjacent to this was a hand written circle with a line through it, to indicate no FM.

Located on the bottom of the document, at 4:50 p.m., the RN note indicated, no rooms open, "pt updated & aware." At 5:30 p.m., the RN note indicated, "Awaiting Room 141B to be cleaned."

A review of the "OB Outpatient Record," dated May 21, 2010, at 6 p.m. indicated Patient 112's chief complaint was decreased FM and occasional contractions. Documented in the, "Problems With Pregnancy," section was, positive Beta-Strep, (infection,) and subchorionic (portion of the placenta,) hemorrhage, bleeding/cramping.

Review of the FMS (fetal monitoring strip-a strip that shows the fetal heart rate) indicated the first time the FHT's (fetal heart tones) were assessed was May 21, 2010, at 5:57 p.m., one hour and 57 minutes after Patient 112 presented to the L&D Department, with a complaint of decreased to no FM.

A review of the facility P&P, "Perinatal Medical Screening Exam," last revised June 2009, was conducted on June 16, 2010. The purpose indicated, "To establish a standardized procedure for providing a medical screening exam for pregnant patient seeking care in the labor & delivery unit....The types of patients appropriate for perinatal medical screening exam by a qualified Labor and Delivery RN's are all pregnant patients with complaint/conditions of the following:...Decreased fetal movement..."

A review of the facility P&P, "Initial Obstetrics Intake", issued May 13, 2010, indicated, "As obstetrical beds become limited the Charge Nurse/designee will triage by acuity. Patients unable to be placed in a patient room at the time they present to the unit will be evaluated by the charge nurse or designee, completing the OB intake form to determine acuity according to the patient's responses: 1. Fetal movement..."

An interview was conducted with RN 4 on June 17, 2010, at 9:30 a.m. RN 4 stated,"If a patient presents with no FM, we would follow it up immediately, it is a serious situation. We would report it to the CN, assess the patient, and at the least get a doppler (ultrasound equipment) to check the FHT."

An interview was conducted with RN 6 on June 17, 2010, at 10 a.m. RN 6 stated, "Any complaint of no FM is an emergent situation. We would put a doppler on the patient. We are the ER of the OB Department. "



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2. On June 17, 2010, Patient 215's record was reviewed. The "OB Intake" indicated the patient arrived to the facility on May 21, 2010, at 6:30 p.m., with EDC on June 8, 2010 (approximately 36 weeks gestational age). The document further indicated, "Reason for visit: Contracting x (for) 2 days; stronger since 1600 (4 p.m.)..."

The document further indicated:
*On May 21, 2010, at 7:25 p.m. - "feels better w/ walking pain felt back";
*On May 21, 2010, at 7:55 p.m. - "No abdomen pain, vag(inal) bleeding, baby active."

The "OB Outpatient Record" dated May 21, 2010, at 8:20 p.m. (1 hour and 50 minutes after arrival), indicated the patient underwent MSE. The document referred to "see computer charting."

The computerized nurse's notes indicated on May 21, 2010, at 8:20 p.m., Patient 215 was oriented to LDR.

The record did not indicate assessment of the fetal heart rate and vital signs from 6:30 p.m. through 8:20 p.m. (approximately 1 hour and 50 minutes after arrival).

3. On June 17, 2010, Patient 216's record was reviewed. The "Obstetrical History-Physical/Update" indicated the patient had a SROM on March 19, 2010, at 4 p.m., and proceeded to the hospital approximately 5:30 p.m. to 6 p.m.

The "OB Outpatient Record" dated March 19, 2010, at 7:51 p.m. (approximately 1 hour and 50 minutes after arrival), indicated the patient underwent MSE. The patient's chief complaint was "SROM at 4 p.m." The patient's EDC was March 27, 2010 (approximately 37 weeks gestational age). The vital signs section was left blank.

The computerized nurse's notes dated March 19, 2010, at 7:56 p.m., indicated, "Pt (Patient) states that she SROM at 4pm today. She about 45 mins (minutes) away and had to wait for a while in the wait area due to labor being full. Pt states that she is not having UC (uterine contractions) at this time and the fluid cont. (continues) to leak. Clear fluid noted by the pt and with out oder (odor). Pt into room LDR 141B changed into gown and EFM applied..."

The record did not indicate assessment of the fetal heart rate and vital signs from 6 p.m. through 7:56 p.m. (approximately 1 hour and 50 minutes after arrival).



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4. On June 16, 2010, Patient 504's record was reviewed. The "OB Intake" indicated the patient arrived at the facility on May 21, 2010, at 1:10 p.m., with an EDC of June 13, 2010, (approximately 36 weeks gestational age). The document further indicated, "Reason for visit: Regular contractions."

In addition, the document indicated:
*On May 21, 2010, at 1:30 p.m. - "No change" and
*On May 21, 2010, at 2 p.m. - "To 141B."

The "OB Outpatient Record" was not dated, timed, or completed.

The "Labor and Delivery Admission Assessment" dated May 21, 2010, at 2:12 p.m., (one hour and two minutes after arrival), indicated Patient 504 underwent MSE.

The computerized nurse's notes indicated on May 21, 2010, at 2:10 p.m., the monitor status for Patient 504 was "On."

The record did not indicate assessment of the fetal heart rate, uterine contractions, and vital signs from 1:10 p.m., through 2:15 p.m., (approximately one hour after arrival).

5. On June 17, 2010, Patient 506's record was reviewed. The "OB Intake" indicated the patient arrived at the facility on June 7, 2010, at 12:30 a.m., with an EDC of August 11, 2010, (approximately 31 weeks gestational age). The document further indicated, "Reason for visit: cramping,..."

The "OB Outpatient Record" dated June 7, 2010, at 1:10 a.m., (40 minutes after arrival), indicated Patient 506 underwent a MSE. The document referred to "See trace view."

The computerized nurse's notes indicated on June 7, 2010, at 1:09 a.m., the monitor status for Patient 506 was "On."

The record did not indicate assessment of the fetal heart rate, uterine contractions, and vital signs from 12:30 a.m., through 1:10 a.m., (approximately 40 minutes after arrival).

6. On June 17, 2010, Patient 505's record was reviewed. The "OB Intake" indicated the patient arrived at the facility on May 21, 2010, at 6:55 p.m., with an EDC of September 13, 2010, (approximately 24 weeks gestational age). The document further indicated Patient 505 was pregnant with twins, and "Reason for visit: contractions since 1730 (5:30 p.m.).

The "OB Outpatient Record" dated May 21, 2010, at 7:30 p.m., (35 minutes after arrival), indicated Patient 505 underwent a MSE. The document referred to "See trace view."

The computerized nurse's notes indicated on May 21, 2010, at 7:30 p.m., the vital signs for Patient 505 were taken and recorded.

The record did not indicate assessment of the fetal heart rates (twins), uterine contractions, and vital signs from 6:55 p.m., through 7:30 p.m., (approximately 35 minutes after arrival).

On June 16, 2010, at 4 p.m., the OBM and DWS were interviewed. The OBM stated the facility did not have any criteria to determine how soon a patient will undergo MSE to determine if an EMC existed. The DWS stated MSE should be provided immediately when a patient came in the unit. The OBM stated the facility could only conduct a MSE in a room which provided privacy to the patient. There were occasions where patients had to wait when the OB unit was full. She stated MSE included obtaining vital signs and fetal heart monitoring. The date and time on the "OB Outpatient Record" or the "Labor and Delivery Admission Assessment" forms indicated when the patient had their MSE.

On June 17, 2010, the facility policy titled, "Perinatal Medical Screening Exam" last revised on June 2009, was reviewed. The policy indicated the following:

"Purpose: To establish a standardized procedure for providing a medical screening exam for pregnant patients seeking care in the labor & delivery unit..."

"B. Medical Screen Exam: required examination of the patient to determine whether an emergency condition exists, including the use of ancillary services."

"...It is important to note that, in the case of a pregnant woman, the health of the fetus also must be considered in determining whether an "emergency medical condition" exits (exists)."

"Policy: A. All patients reporting for evaluation will receive the standard obstetrical evaluation performed by a qualified evaluator..."

"Procedure: A. The types of patients appropriate for perinatal medical screening exam by a qualified Labor and Delivery RN's are all pregnant patients with complaint/conditions of the following:
1. Uterine contractions or pain after 20 weeks gestation.
2. Vaginal bleeding, greater than 20 week's gestation
3. Rupture of membranes
4. Decreased fetal movement
5. Symptoms of urinary tract infection/pyelonephritis
6. Preeclampsia (BP>140/90 with proteinuria after 20 weeks gestation)
7. OB patients admitted through the Emergency Department requiring a perinatal medical screening examination
8. Other common complications of pregnancy (e.g. preterm labor, gestation diabetes, chronic hypertension)"

"C. The Perinatal medical screening exam will include the following...3. Obtain patient's vital signs...5. Apply EFM for interpretation of fetal heart rate baseline variability, periodic and episodic changes (accelerations & decelerations) and uterine contractions..."