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Tag No.: A0043
Based on a medical record review, a review of the facility policies and procedures and staff interviews, it was determined that the governing body failed to effectively carry out the responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the facility's lack of compliance with the following Condition of Participation for hospitals:
42 CFR 482.23- Nursing Services
Tag No.: A0385
Based on a medical record review, staff interviews, review of facility policies and procedures and review of the nationally recognized obstetrics nursing guidelines, it was determined that the facility failed to ensure an organized nursing service.
Cross Reference: CRF 482:23(b)(3)
Tag No.: A0395
Based on a medical record review, review of facility policies and procedures review of the recommended obstetrics guidelines, it was determined that the facility failed to ensure that every patient is assessed as warranted by changes in the patient's condition.
Findings Include:
Reference #1: Facility Policy #640-044-130, titled "Care of the Patient; Post Partum" refers to the following reference as to the procedure that the facility adheres to.
Mattson, S., Smith, J.E., (1997) AWHONN: Core Curriculum for Maternal-Newborn Nursing, Second Edition, Philadelphia, W.B. Saunders Company. p. 393
Chapter 21; Hypertension in Pregnancy:
Objectives:
3. Identify factors that place women at greater risk for preeclampsia
4. Correlate history and physical findings with signs and symptoms of preeclampsia, eclampsia and HELLP [Hemolysis, Elevated Liver enzymes, Low Platelets] syndrome
5. Predict maternal and fetal complications
6. Formulate nursing interventions to alleviate or prevent potential problems identified in the nursing assessment
7. Summarize the treatment of preeclampsia, eclampsia and HELLP syndrome.
Introduction:
A. Introduction: Hypertensive disorders of pregnancy can result in life-threatening complications ...
3. Hypertension during pregnancy is one of the leading causes of maternal morbidity and mortality ...
4. Therapy is aimed at controlling hypertension and seizures, preventing long-term morbidity and preventing maternal, fetal or neonatal death
E. Differentiation of hypertensive disorders
1. PIH [Pregnancy Induced Hypertension]
a. Preeclampsia
(1) Hypertension
(a) Systolic pressure is at least 140 mm Hg
(b) Diastolic pressure is at least 90 mm Hg
(c) At least two elevated values 6 or more hours apart
(d) Relative hypertension may be identified with a systolic increase of 30 mm
Hg and a diastolic increase of 15 mm Hg above baselines (e.g., 120/90 compared
with 90/60 at first prenatal visit)
(e) Relative hypertension should alert health care providers to the need for further evaluation and close surveillance. Severe preeclampsia is defined as one of the following:
(1) Blood pressure
(a) Systolic pressure is at least 160 mm Hg
(b) Diastolic pressure is at least 110 mm Hg
(7) Epigastric or right upper quadrant pain
Eclampsia
(d) Other risks include cerebrovascular accident (CVA), cerebral edema, anoxia, coma
and maternal death
2. Eclampsia should be preventable if preeclampsia is recognized in its early stages, surveillance is adequate and therapy is appropriate
Reference #2: The facility's policy #670-044-130, titled "Care of the Patient; Post Partum" stipulates: PURPOSE/GOAL: To determine care through assessment/reassessment of patient care needs. ...To identify potential complications and take appropriate action to minimize risk to both mother and baby.
POLICY: 3. All abnormal findings, potential complications, and lack of progress toward care goals will be communicated to the physicians/midwife for clinical assessment/intervention.
PROCEDURE: 5. Assessment, Reassessment, Care and Education:
i. Pain/Discomfort: Assess for verbal and nonverbal signs of discomfort ...Provide pain medication/analgesics as ordered by physician and evaluate effectiveness.
ii. REFERENCES: ...AWHONN: Core Curriculum for Maternal-Newborn Nursing, 1997.
Reference #3: Facility Policy #640-084-110, titled "High Risk Criteria: Obstetric Patient," stipulates: PURPOSE: To Identify the obstetric patient who may present a higher risk for a safe pregnancy and delivery. POLICY: It is the philosophy of Monmouth Medical Center ...early identification and treatment of "high risk" patients that patients will receive the appropriate level of care in the appropriate setting thereby decreasing the risk for preterm delivery and maternal/infant morbidity/mortality.
Reference #4: Facility In-Services: Titled "Hypertensive Disorders of Pregnancy"
"Risk Factors for Development of Preeclampsia" Criteria Mild-moderate B/P [Blood Pressure] 140/90 or higher, or a rise of 30 mm HG systolic and 15 mm Hg diastolic from baseline ... Severe B/P 160/110 or above ... "Postpartum Management" Delivery of baby does not immediately reverse the pathophysiologic changes of preeclampsia ...continue therapy and monitoring ...Continue to be alert for early signs of preeclampsia complications such as:-HELLP syndrome, -increased intracranial pressure, -intracranial hemorrhage ...
"HELLP Syndrome" Most common physical complaints; epigastric or RUQ [right upper quadrant] pain, N&V [nausea and vomiting] ... "Complications" ...subcapsular hematoma.
Reference #5: Department of Pathology: Chemistry
Reference Range: [Alanine aminotransferase] ALT 10-43, [Aspartate aminotransferase] AST 13-41, [Lactate dehydrogenase] 116-243, [Blood urea nitrogen] BUN 5-21, Alkaline phosphate 42-119, Blood Glucose 70-110, Total Protein 6.4-8.3, Creatinine 0.40-1.10, Albumin 3.5-5.0, Amylase 28-118
1. Review of Medical Record #2, in the presence of Staff #2 revealed the following:
a. The Antepartum Record (office prenatal visits) for Patient #2 indicates the following blood pressures:
3/10/11-108/64, 6/14/11-110/68, 5/2/11-108/60, 5/31/11-120/64, 6/28/11-106/68,
7/25/11-112/70, 8/8/11-112/70, 8/24/11-118/72, 9/6/11-120/70, 9/15/11-108/72,
9/21/11-120/70.
b. Review of the L&D [Labor and Delivery] Admission Assessment dated 9/30/11 at 1941 indicated: Admission Vital Signs; 147/99. This was significantly higher than the baseline (Antepartum) blood pressures, stated above.
c. There is no evidence that the L&D nurse notified the primary care physician (PCP) of the elevated admission blood pressure.
d. The above was confirmed by Staff #2.
2. A review of the Physician Orders dated 9/30/11 at 2000 indicated:
Vital signs every 15 minutes for the first hour, then every 30 minutes X 2, then every 4 hours X 12 hours.
a. The Admission Assessment dated 9/30/11 revealed a blood pressure of 147/99 at 2008.
b. There is no evidence in the medical record of a blood pressure between 9/30/11 at 2008 and 10/1/11 at 0402. Seven hours and 56 minutes lapsed between the first and the second blood pressure being taken.
c. The above was confirmed by Staff #2.
3. Review of the Maternal Flow Sheet indicated the following:
a. From admission on 9/30/11 at 2008 to 10/1/11 at 1826, 21 systolic blood pressures were at or above 140 mm Hg, ranging from 140-162 mm Hg, and 13 diastolic blood pressures were at or above 90 mm Hg, ranging from 90-106. These numbers are indicative of hypertension as per reference #1.
b. There was no indication in the medical record that the Registered Nurse (RN) notified the health care provider/Obstetrics Gynecologist (OB/GYN), of the elevated blood pressures of Patient #1, prior to delivery.
c. There was no evidence in the medical record of further evaluation and surveillance of Patient #1, from the health care provider/OB/GYN, prior to delivery.
d. The above was confirmed by Staff #2.
4. Review of the Delivery Summary: GYN [Gynecological] HISTORY (per Patient or Prenatal Record); Denies having any complications.
Delivery Date: 10/01/11, 1849
Outcome: Liveborn
5. Review of the Vaginal Delivery- Recovery sheet indicated:
a. Blood pressures:
10/1/10:
Time - B/P
1856 - 136/83
1911 - 154/97
1926 - 161/93
1937 - 141/90
1941 - 154/97
1956 - 160/95
2011 - 161/96
2020 - 152/102
2026 - 158/97
2041 - 184/103
2056 - 169/108
No B/P taken for 1 hour and 29 minutes
2225 - 175/100
No B/P taken for 1 hour and 44 minutes
10/2/11:
0009 -174/101
0013 - 184/119
0014 - 197/117
0018 - 191/115
0024 - Attempt made to take B/P
0031 - 138/101
0032 - Attempt made to take B/P
0049 - 146/97
0053 - 155/102
0054 - 148/102
b. Review of the Vaginal Delivery Recovery sheet indicated that the patient's pain was as follows:
2030-Mid-epigastric was rated at 7/10 (on a pain scale of 1/10, 10 being the worst pain). Intervention; Bicitra 30 ml. Pain relief was documented at 7/10.
2041-Pain was;10/10.
2050-Pain was rated at 10/10.
2150-Pain was 8/10.
2200-Pain was 10/10. Interventions indicated that a GI [Gastroenterologist] Consult was ordered and Dilaudid 2mg IV was administered.
2200-Pain was rated 10/10.
c. There was no evidence in the medical record that the elevated blood pressures were addressed by the primary health care provider/OBGYN.
6. Review of the Nursing Notes indicated the following:
10/1/11 - 2030: Patient complained of severe mid-epigastric pains and burning radiating up her chest. MD [OB/GYN] at bedside. Patient evaluated, active bowel sounds present all 4 quadrants, Bicitra orders received.
2032 - Orders received for IV Dilaudid 0.5 mgs. patient requests ? dose...
2041 - MD [OB/GYN] aware of patient's B/P. Preeclampsia labs ordered....Patient unable to stay still, bending over in pain. Patient vomiting.
2050 - Preeclampsia labs drawn...Patient remains in pain.
2100 - Patient pain status remains the same, MD [OB/GYN] made aware. MD [OB/GYN] at bedside. Dilaudid 0.5 mg given IV push.
2120 - Lab results back from lab. MD [OB/GYN] made aware. No abnormal labs present...
2130 - Patient states relief from pain. "I'm feeling much better."
2147 - Patient in pain again...Patient vomited...
2200 - ...Epigastric pain present. Patient and husband made aware a GI consult is in place...
2215 - ...GI consult via phone to OBGYN. Plan of care discussed. Orders received for upper abdominal X-ray, amylase and lipase levels, Maalox 30 ml now.
2216 - Unable to give Maalox at this time, unavailable...
2220 - Dilaudid 2 mg administered IV push.
2225 - Patient unable to remain still...
2255 - Maalox 30 ml given PO.
2300 - 40 mg Protonix given IV.
2315 - Patient to Emergency Department (ED) for X-ray...Patient continues to appear in pain 10/10 localized mid-epigastric pain. Patient vomiting. OBGYN made aware of patient status and X-ray results. General Surgery consult requested.
2345 -.Surgery Resident at bedside. Patient evaluated.
2355 -.Patient states "do anything to stop this pain." OB/GYN at bedside...orders for morphine 2 mg received...
10/2/11 - 0005 Morphine 2 mg IV push
0009 - Pulse Ox applied, patient extremely lethargic...
0010 - OB/GYN at Bedside, patient cognitively intact, lethargic.
0018 - OB/GYN assessing patient. Left side facial drooping noted. Patient unable to lift left arm. Code Stroke called.
0028 - Code Stroke team at bedside ...
0035 - Magnesium Sulfate initiated. 4 gm loading dose. 115 Blood Sugar finger stick...
0045 - Patient intubated...
7. Review of the Physicians Progress Notes by the OB/GYN revealed the following:
Admit Note:
9/30/11 at 2015, Cervidel started. No mention of elevated admission B/P.
10/1/11 at 2230; no mention of elevated B/P.
1240 - Vital signs stable ...
1650 - Patient without complaints, B/P 132/68.
1800 - Patient without any complaint, no complaint of epigastric pain mentioned, 10/1/11
10/2/11 - 0210 Addendum by the health care provider/OB/GYN at 10/1/11 2030;
Patient complained mid-epigastric pain with nausea, given Bictra with no relief. ..severe mid-epigastric pain GI called...Maalox given...amylase and lipase ordered WNL [within normal limits]. Surgery consult ordered..Given Dilaudid for pain. Pain not improved...2 mg Morphine IV...patient exhibits facial droop on left side. Code Stroke called. B/P 137/102, magnesium sulfate initiated...After paralysis went to CT-Scan...to ICU [Intensive Care Unit].
8. Review of the History and Physical Form in the medical record, from the PCP/OB/GYN indicated:
10/2/12 at 0200; Code Stroke / ICU transfer note:
Code stroke was called around 12:24 am to L&D... Patient had delivered 4 hours earlier...
"when she started to complain of epigastric pain she was given ? mg Dilaudid x 2, then 2 mg Dilaudid and later 2 mgs morphine IV, which eased her pain." A surgical consult was requested and patient was being evaluated by a surgical resident. It was noticed patient had right facial droop and left sided weakness around 1200 [10/2/11] at this point code stroke was called. When I saw the patient she had right sided facial droop and unable to move left upper and lower extremities. Stat CT of head without contrast ordered 1230 with labs work including PT/INR. Patient started vomiting and anesthesia needed to intubate to secure airway. CT scan done at 0100 and revealed right intracranial/intraparenchymal and subarachnoid bleed with 5 mm RaL shift. The patient was brought to the ICU, being evaluated by neurologist and neurosurgeon. Patient started on Mannitol 50 gm IV
BP 175/122, RR 10
AST - 791
ALT - 235
CNS: Unable to assess as patient under the effect of paralyzing agent.
Abdomen; soft (+) Bowel Sounds
A/P (Assessment and plan) Code Stroke with right facial droop and left hemiparesis.
Likely secondary to arterial venous malformation (AVM) vs. HELLP syndrome, vasculitis. Patient admitted to ICU.
9. Review of the Discharge Summary in the medical record written by the OB/GYN, indicated:
a. Hospital Course:
...39 weeks, 6 days presented in L&D for elective induction of labor. Vitals were stable ...
b. Assessment and Plan:
10/1/11 at 0830 no complaints, no nausea or vomiting, vitals stable.
1245 - status post epidural patient had complained of some ...mid-epigastric tenderness. ..resolved over a period of time.
1650 - no nausea or vomiting, B/P 137/68, no complaints at this time.
1800 - no complaints.
1915 - delivery note written, female infant APGAR 9 at 1 minute, 9 at 5 minute at 1849. Patient without complaints.
c. 10/2/11, at 0210 Addendum written by the health care provider/OB/GYN which notes: at approximately 2030 patient complained of mild-epigastric pain with nausea. Given Bicitra with no relief...Complaint of severe mid-epigastric pain. Patient ' s husband requested GI consult. GI MD called. Maalox 30 ml given. Amylase and Lipase ordered along with pre-eclamptic labs. Patient had a surgical consult. An upright AP film ordered, showed possible dilated loops of bowel. Dilaudid given for pain, no response, 2 mg Morphine IV given within 5 minutes. Patient ex facial droop on left side. Code stroke called, B/P 137/102, Magnesium Sulfate loading dose given for seizure prophylaxis anesthesia intubated patient. Patient sent to CT scan. Neurosurgeon called. Patient to Intensive Care Unit (ICU). Patient ' s initial blood work on 10/1/11 at 2050 were; ALT-18, AST-40, Alkaline. Phosphate-59. Amylase-47, Lipase 26, Blood Glucose 90, BUN 10 Creatinine-0.77 Uric Acid-7.5, Total Protein 5.6, Albumin 3.2. Labs discussed with husband, were sent immediately upon presentation of mid-epigastric tenderness. At time of stroke labs drawn again, ALT had now jumped to 490, AST-718 and Alkaline Phosphates-241. By 1:30 in the morning, the ALT had gone to 509 and AST 791. By 2:59 the ALT was 717 and AST 1303. By 5:32 AM, ALT-795, AST 1688 and LDH 2988.
Neurosurgeon spoke to husband over the phone at home re; results of CT scan...I (OB/GYN) was called to the ICU as patient's BP continued to drop. Patient was started on Levophed drip. Second CT scan reviewed by radiology, showed worsening swelling in brain, questionable whether or not patient was herniating. Neurosurgeon made aware. Patient taken to the Operating Room (OR). CT scan and abnormal liver US were discussed with husband. As per radiologist there was no hematoma or sub capsular hemorrhage of the liver. LFTs continue to rise, platelets down to 41,000...surgical team attempting to place femoral line and platelets were being hung.
On 10/2/11 at approximately 1310 after patient was taken to OR by neurosurgeon, a deceleration of death by Neurologic criteria was filled out. ...apnea test done, patient failed to have spontaneous breathing, no gag reflex, no corneal reflex...Patient met criteria for brain death. Patient extubated. The patient lost cardiac activity at 1507 on the monitor. Patient pronounced dead 10/2/11 1508 with family at bedside...Autopsy permission not granted by husband and family. The cause of death was intracranial hemorrhage secondary to unknown etiology, possibly HELLP syndrome.
d. There was no evidence in the medical record that the elevated blood pressures were addressed by the health care provider/OB/GYN until after Code Stroke was called.
e. The above was confirmed by Staff #2.