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OTTUMWA REGIONAL HEALTH CENTER 1001 E PENNSYLVANIA OTTUMWA, IA 52501 June 12, 2013
VIOLATION: MEDICAL SCREENING EXAM Tag No: A2406
Based on a review of policy/procedures, review of medical record documentation, physician peer review and interview with staff, the hospital failed to ensure the staff of their Emergency Department (ED) provided a complete medical screening examination (MSE) sufficient to determine whether an emergency medical condition (EMC) existed for 1 of 30 patients presenting to the Emergency Department (ED) with the same or similar diagnosis between 11/1/12 and the time of the onsite investigation (Patient #4).

Failure of the ED staff to provide an appropriate MSE in the ED for each patient could result in inappropriate, inadequate, or ineffective care to treat any patient with an EMC, potentially resulting in the delay of treatment and worsening of the patient's condition.

Findings include:

1. Review of the hospital policy/procedure titled "EMTALA: Medical Screening Examination and Stabilization Policy," effective 4/1/2011, revealed in part, the following: "b. Definition of MSE. An MSE is the process required to reach, with reasonable clinical confidence, the point which it can be determined whether the individual has an EMC or not. It is not an isolated event. The MSE must be appropriate to the individual's presenting signs and symptoms and the capability and capacity of the facility."

"e. Extent of the MSE varies by presenting symptoms. The MSE may vary depending on the individual's signs and symptoms: i. Depending on the individual's presenting symptoms, an appropriate MSE can involve a wide spectrum of actions, ranging from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies such as (but not limited to) lumbar punctures, clinical laboratory tests, CT scans and other diagnostic tests and procedures."

2. Review of Patient #4's ED medical records revealed the following three visits to the hospitals ED during the month of November, 2012.

a. Patient #4 presented on Sunday November 4, 2012 at 11:49 AM complaining of nausea and vomiting which occurred after Vicodin (pain medication) was changed to Oxycontin (pain medicine with side effects that include nausea and vomiting). The ED nurse documented the patient's blood pressure was 130/50 (normal range 130/50) and heart rate was 112 beats per minute (normal is 60 to 100 beats per minute).

The ED physician examined Patient #4 and ordered medications to treat "severe nausea with vomiting" and intravenous fluids to treat the patient's moderate dehydration. At 12:55 PM lab testing revealed Patient #4 had a normal hemoglobin level of 14.0 (normal is 12.3 - 15.1 deciliters per gram and lower than normal levels may indicate the presence of bleeding).

At 3:04 PM, the ED physician determined Patient #4 was ready for discharge. At 4:00 PM, the ED nurse documented evidence the patient's heart rate was 98 beats per minute and the patient left the ED accompanied by family.

b. On Sunday November 25, 2012 at 10:23 AM, Patient #4 returned to the ED with complaints of nausea and vomiting. At 10:25 PM, the triage nurse documented Patient #4's blood pressure was 154/90 (elevated) and the patient's heart rate was 116 beats per minute (abnormally elevated). Further documentation revealed the patient reported taking Lyrica (medication used for treatment of fibromyalgia) and Oxycontin (pain medication with possible side effects of nausea and vomiting) six weeks ago. On November 4, 2012, when the patient was seen in the ED due to nausea, vomiting, and weakness. The patient "states was taken off Oxycontin at that time." "Symptoms are now recurring starting on Thursday night."

The History of Present Illness documented by Practitioner A, MD (Medical Doctor) revealed the chief complaint of vomiting started just prior to the patient's arrival and was still present. Patient has had nausea and abdominal pain. The patient has had vomiting (no blood). The patient reported a bowel movement within the last 36 hours without diarrhea, black stools, constipation or flank pain. The illness was described as moderate. Similar symptoms previously that occurred occasionally.

At 11:10 AM, the ED physician examined Patient #4 and documented the patient complained of nausea and vomiting and abdominal pain. The initial physician exam revealed the patient had a soft and nontender abdomen. Bowel sounds were normal. No organomegaly. No mass. Patient was in moderate distress. The physician's orders showed orders for IV (intravenous) administration of Zofran, Lorazepam and Promethazine (all three drugs are used to treat nausea and vomiting). The clinical impression documented by Practitioner A showed a final diagnosis intractable vomiting.

Documentation in Patient #4's medical record revealed Patient #4 received intravenous fluids and medications to treat nausea and vomiting between 11:50 AM and 3:25 PM. At 12:05 PM lab testing revealed the patient had an abnormal (low) hemoglobin level of 10.5 grams per deciliter (a drop of of 3.5 deciliters per gram from 11/4/12). At 1:39 PM, the ED physician documented Patient #4 had intractable vomiting (repeated vomiting that resists medical treatment) and was "very little better" (sic) after the IV administration of drugs for the nausea and vomiting.

At 3:26 PM, the ED nurse documented the patient's blood pressure was 139/83 (elevated) and heart rate was 109 beats per minute (abnormally elevated). Further documentation indicated the intravenous fluids were discontinued ant Patient #4 was discharged . The patient's medical record lacked evidence that Patient #4 received further examination to determine whether the patient was experiencing gastrointestinal bleeding (an emergency medical condition) as potentially indicated by the patient's 3.5 gram drop in hemoglobin, the patient's elevated heart rate, and the patient's on going complaints of nausea, vomiting, and abdominal pain.

Discharge instructions provided to and signed by the patient showed treatment for intractable vomiting. Medications were prescribed for nausea and allergies and the patient instructed to follow up with primary physician. Return to ED or call if develop fever, bloody vomit, persistent severe vomiting or new symptoms.

c. On Monday, November 26, 2012 at 6:00 PM, approximately 26 hours after discharge from the ED, Patient #4 returned to the ED in severe distress and pain. The ED nurse documented Patient #4's blood pressure was 98/71 (abnormally low) and heart rate was 112 (abnormally elevated). A CT scan (special type of x-ray) determined the patient had a moderate amount of fluid in the abdomen (an abnormal finding) and a surgeon was contacted. At 9:40 PM, Patient #4 was taken to the operating room for an emergency repair of a perforated peptic ulcer (an ulcer that perforated the lining of the stomach allowing fluid to leak into the abdominal cavity causing infection).

3. During an interview on 6/12/13 at 7:00 AM, Practitioner B, MD (ED Medical Director) stated when reviewing Patient #4's medical record, the patient's abdomen was soft and nontender. The physician had to palpate all four quadrants to determine this. Based on the physician's documentation, a CT scan would not be necessary, but the physician documented patient very little better on discharge and the hemoglobin was 10.3, this is concerning. The standard of practice for a CT scan is if the patient has a hard abdomen, peritoneal signs or guarding with rebound tenderness.

Review of the Physician's Peer Review, dated 6/19/2013, revealed Patient #4 did not receive an adequate medical screening examination on 11/25/12 due to the hospital failure to investigate causes of the 3.5 gram drop in hemoglobin between the 11/4/12 and 11/25/12 ED visits for this individual with abdominal pain and tachycardia ( faster than normal heart rate).
VIOLATION: COMPLIANCE WITH 489.24 Tag No: A2400
Based on medical record review, policy/procedure review, and staff interview, the hospital administrative staff failed to enforce policies/procedures requiring a Medical Screening Exam (MSE) sufficient to determine if an emergency medical condition (EMC) existed for 1 of 30 patients presenting to the Emergency Department (ED) with the same or similar diagnoses 11/1/12 through the time of the onsite investigation (Patient #4).

Failure to enforce policies that ensure all patients presenting to the ED receive an appropriate MSE, could result in a patient leaving the ED with an undetected EMC. This could result in a delay in life saving treatment for the patient.

Findings include:

1. Review of the hospital policy/procedure titled "EMTALA: Medical Screening Examination and Stabilization Policy," effective 4/1/2011, revealed in part, the following: "b. Definition of MSE. An MSE is the process required to reach, with reasonable clinical confidence, the point which it can be determined whether the individual has an EMC or not. It is not an isolated event. The MSE must be appropriate to the individual's presenting signs and symptoms and the capability and capacity of the facility."

"e. Extent of the MSE varies by presenting symptoms. The MSE may vary depending on the individual's signs and symptoms: i. Depending on the individual's presenting symptoms, an appropriate MSE can involve a wide spectrum of actions, ranging from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies such as (but not limited to) lumbar punctures, clinical laboratory tests, CT scans and other diagnostic tests and procedures."

2. Review of Patient #4's ED medical records revealed the following three visits to the hospitals ED during the month of November, 2012.

a. Patient #4 presented on Sunday November 4, 2012 at 11:49 AM complaining of nausea and vomiting which occurred after Vicodin (pain medication) was changed to Oxycontin (pain medicine with side effects that include nausea and vomiting). The ED nurse documented the patient's blood pressure was 130/50 (normal range 130/50) and heart rate was 112 beats per minute (normal is 60 to 100 beats per minute).

The ED physician examined Patient #4 and ordered medications to treat "severe nausea with vomiting" and intravenous fluids to treat the patient's moderate dehydration. At 12:55 PM lab testing revealed Patient #4 had a normal hemoglobin level of 14.0 (normal is 12.3 - 15.1 deciliters per gram and lower than normal levels may indicate the presence of bleeding).

At 3:04 PM, the ED physician determined Patient #4 was ready for discharge. At 4:00 PM, the ED nurse documented evidence the patient's heart rate was 98 beats per minute and the patient left the ED accompanied by family.

b. On Sunday November 25, 2012 at 10:23 AM, Patient #4 returned to the ED with complaints of nausea and vomiting. At 10:25 PM, the triage nurse documented Patient #4's blood pressure was 154/90 (elevated) and the patient's heart rate was 116 beats per minute (abnormally elevated). Further documentation revealed the patient reported taking Lyrica (medication used for treatment of fibromyalgia) and Oxycontin (pain medication with possible side effects of nausea and vomiting) six weeks ago. On November 4, 2012, when the patient was seen in the ED due to nausea, vomiting, and weakness. The patient "states was taken off Oxycontin at that time." "Symptoms are now recurring starting on Thursday night."

The History of Present Illness documented by Practitioner A, MD (Medical Doctor) revealed the chief complaint of vomiting started just prior to the patient's arrival and was still present. Patient has had nausea and abdominal pain. The patient has had vomiting (no blood). The patient reported a bowel movement within the last 36 hours without diarrhea, black stools, constipation or flank pain. The illness was described as moderate. Similar symptoms previously that occurred occasionally.

At 11:10 AM, the ED physician examined Patient #4 and documented the patient complained of nausea and vomiting and abdominal pain. The initial physician exam revealed the patient had a soft and nontender abdomen. Bowel sounds were normal. No organomegaly. No mass. Patient was in moderate distress. The physician's orders showed orders for IV (intravenous) administration of Zofran, Lorazepam and Promethazine (all three drugs are used to treat nausea and vomiting). The clinical impression documented by Practitioner A showed a final diagnosis intractable vomiting.

Documentation in Patient #4's medical record revealed Patient #4 received intravenous fluids and medications to treat nausea and vomiting between 11:50 AM and 3:25 PM. At 12:05 PM lab testing revealed the patient had an abnormal (low) hemoglobin level of 10.5 grams per deciliter (a drop of of 3.5 deciliters per gram from 11/4/12). At 1:39 PM, the ED physician documented Patient #4 had intractable vomiting (repeated vomiting that resists medical treatment) and was "very little better" (sic) after the IV administration of drugs for the nausea and vomiting.

At 3:26 PM, the ED nurse documented the patient's blood pressure was 139/83 (elevated) and heart rate was 109 beats per minute (abnormally elevated). Further documentation indicated the intravenous fluids were discontinued ant Patient #4 was discharged . The patient's medical record lacked evidence that Patient #4 received further examination to determine whether the patient was experiencing gastrointestinal bleeding (an emergency medical condition) as potentially indicated by the patient's 3.5 gram drop in hemoglobin, the patient's elevated heart rate, and the patient's on going complaints of nausea, vomiting, and abdominal pain.

Discharge instructions provided to and signed by the patient showed treatment for intractable vomiting. Medications were prescribed for nausea and allergies and the patient instructed to follow up with their primary physician. Return to ED or call if develop fever, bloody vomit, persistent severe vomiting or new symptoms.

c. On Monday, November 26, 2012 at 6:00 PM, approximately 26 hours after discharge from the ED, Patient #4 returned to the ED in severe distress and pain. The ED nurse documented Patient #4's blood pressure was 98/71 (abnormally low) and heart rate was 112 (abnormally elevated). A CT scan (special type of x-ray) determined the patient had a moderate amount of fluid in the abdomen (an abnormal finding) and a surgeon was contacted. At 9:40 PM, Patient #4 was taken to the operating room for an emergency repair of a perforated peptic ulcer (an ulcer that perforated the lining of the stomach allowing fluid to leak into the abdominal cavity causing infection).

3. During an interview on 6/12/13 at 7:00 AM, Practitioner B, MD (ED Medical Director) stated when reviewing Patient #4's medical record, the patient's abdomen was soft and nontender. The physician had to palpate all four quadrants to determine this. Based on the physician's documentation, a CT scan would not be necessary, but the physician documented patient very little better on discharge and the hemoglobin was 10.3, this is concerning. The standard of practice for a CT scan is if the patient has a hard abdomen, peritoneal signs or guarding with rebound tenderness.

The physician failed to follow the hospital policy and conduct a complete medical screening exam for this patient by not acquiring further testing when the patient had a low hemoglobin of 10.3 to rule out gastro-intestinal bleeding or the source causing the low hemoglobin.