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Based on observation, interview, and record review the facility failed to safeguard the confidentiality of patient records Any patient with a physician order for a specialty bed was at risk of a breach in confidentiality due to the facility's practice of faxing the entire physician order with confidential patient medical information to the facility central supply service. The central supply staff was not directly involved in patient care, and had no need to know the physician orders for medications, procedures, and tests. This failure has the potential for patient medical information to be used in a manner not authorized by the patient.

Findings:

During a tour of the facility central supply department on 6/21/10 at 2:55 PM, it was observed that a central supply staff member was holding a faxed copy of a patient's physician orders. The orders contained an order for a special mattress for a patient.

Review, on 6/21/10 of the physician orders, revealed that the orders contained additional physician orders for the following:

The patient's diet, clear liquid diet today, NPO (nothing by mouth) after midnight.

Procedure, "Consent for Esophagogastroduodenoscopy (a tube placed down the throat to view the esophagus, stomach and part of the small bowel)".

Medications, such as magnesium citrate (a laxative), golytely (a laxative used for procedures to clean out the bowel), and a tap water enema.

Other patient's orders that were sent to central supply were reviewed and the following orders were noted:

1. Isolation cart R/O (rule out) infections
2. Consult... for wound care, ostomy care
3. Case worker consult
4. Dietary consult
5. Social service consult
6. Wound culture
7. Antibiotic orders
8. O.K. to place Foley cath (tube inserted into the urinary bladder)
9. Continue patients own medication "(she can't take ambien)"
10. Permit ORIF (Open reduction internal fixation) right fracture femur (leg bone)
11. No blood thinners
12. Overhead frame with trapeze
13. Wound treatment orders
14. Excision of Stage 4 (bedsore that has extended through muscle to bone)
15. Sacral decubitus ulcer (bedsore on tailbone) with vacuum placement

During an interview on 6/21/10 at 2:55 PM with the central supply staff member, he stated that he received the faxed physician orders to "fill a patient order."

In an interview on 6/21/10 at 3:00 PM with a Risk Manager, she stated that nurses fax the orders to central supply to order a specialty bed. The Risk Manager further stated that the process for ordering specialty beds has been in place "as long as I have worked here." On 6/22/10 at 2:05 OM the Risk Manager stated that she had worked for the hospital for 4 years and 10 months.

In an interview on 6/22/10 at 1:40 PM with the CNO (Chief Nursing Officer), she acknowledged that the central supply staff did not need a faxed copy of the physician order; they could receive the request for a specialty bed through the hospital's computer (isolating the order).

Based on interview and record review, the hospital failed to ensure that critical radiological results were promptly communicated to the treated physician(s) for one of 32 Patients, Patient 16. This resulted in a missed X-ray finding and serious harm to Patient 16.

Findings:

A review of the medical record revealed that Patient 16 was a patient with advanced metastatic cancer. The medical record was reviewed extensively on 6/22/10 and 6/23/10. An Emergency Department (ED) record dated 4/20/10, and timed 3:38 A.M. indicates the patient presented to the ED with abdominal pain. She also complained of nausea. She was evaluated by a physician in the ED and given Dilaudid (a strong pain medicine) and Intravenous (IV) fluid hydration. Various tests were done, including blood chemistry, complete blood count (CBC), an ultrasound of her gallbladder and a 3 view series of X-rays of her abdomen. The ED physician record indicated that abdominal X-rays were normal ("nl" was checked). The patient did have gallstones on ultrasound. The patient was discharged at 6:40 AM, feeling somewhat better to follow-up with her physician in 1-2 days. The Imaging Report for the abdominal series of X-rays was interpreted by Radiologist Physician D at 11:16 A.M. on that same day. The first paragraph of the report states "Gas is identified underneath the right hemidiaphragm (right half of diaphragm muscle) consistent with free intraperitoneal gas. (Gas in the abdominal cavity, not inside any of the organs) If the patient has not had a recent surgical procedure, perforated viscus (rupture of stomach or intestine) should be considered.

The record of a second ED visit was reviewed, the visit occurred on 4/20/10 at 8:12 A.M. (one and half hours since the previous ED discharge). The chief complaint was chest pain. Another ED provider evaluated the patient, had her take antacids, and pain medication. A ventilation/perfusion scan was performed. This is a test to identify pulmonary embolism (large blood clots in the arteries of the lungs). This was negative. Several other tests were performed. There is no evidence that the X-rays from the previous visit were reviewed. There was no indication that the misread on the X-ray had been communicated to the ED physicians from the Radiology Department. The patient was discharged at 2:00 P.M.

The third ED visit occurred on 4/21/10 at 12:58 P.M. (23 hours after discharge from the second ED visit). This record was reviewed and contained the following information. The patient arrived by ambulance. The chief complaint was pain in the right upper part of the abdomen. She had visited her primary doctor, and fainted in his office. She had a low blood pressure, was diaphoretic (cold sweat). Her blood pressure continued to drop in spite of multiple therapeutic measures, suggesting the patient was in shock. The ED physician's examination showed her to have a diffusely tender abdomen. Under the X-ray section of the record is the entry "CT Ap-perf viscus, met breast." This means a CT (CAT scan) scan was done to rule out appendicitis, and instead, a perforated viscus was seen, suspected to be due to metastatic breast cancer. A surgeon was consulted urgently.

A History and Physical typed report was dictated by Physician E on 4/22/10. This is the admission to the ICU after the surgery. This record was reviewed and contained the following information. In the assessment area, the following diagnoses relevant to the investigation are listed; acute respiratory failure, status post exploratory laparotomy, septic shock, acute peritonitis (inflammation of the lining of the abdomen), multiple intra-abdominal abscesses (pockets of infection), ruptured duodenal ulcer, and extensive necroses (tissue death) of gastric and surrounding tissue.

The Medical Director of the ED (Physician D) was interviewed 6/23/10 at 10:12 AM. He was asked about when the error in the reading of the abdominal X-ray was recognized. He answered that it was at the time of the patient's third visit to the ED when it was obvious the patient needed surgery. The X-ray was reread by the treating physician in the ED and the diagnosis of a ruptured viscus was made.

Policies were reviewed on 6/23/10 at 8:00 A.M. Two policies were provided by the hospital entitled "Interpretation of Emergency Room Films By Imaging Services." The first was the active policy in place effective 07/2009. It states, "1. All exams obtained in the Emergency room (ER) during working hours are formally interpreted by the radiologist the same day of the examination ...3. Preliminary interpretations are provided for all ER exams by ER physicians; those are checked by radiologists at time of formal interpretation for variances. Variances are stamped as "VARIANCE" and a copy of the Radiologist's preliminary faxed to the ER for clinical follow-up ... " A second draft policy was provided as a correction by the Medical Director of the ED. The corrected policy was changed to mandate ED physicians to enter their X-ray readings into the Radiology computer system (PACS). The radiologist is then able to see if the ED reading is different from his own. In the case of Patient 16, the radiologist did not compare his reading to the ED reading. The draft policy also added "7. Radiologist will notify Emergency Department Physician by telephone of any critical variances as defined in ... " This did not occur for Patient 16 according to the radiologist, Physician A, on 6/22/10 at 2:55 PM.

Another policy was provided by the hospital entitled "Diagnostic Follow Up," last revised 1/2009. It provides guidelines for identifying radiology variances, positive cultures, or other diagnostic tests that may require patient follow up. Under policy it states "B. The Emergency Department physician is to read x-rays obtained during the course of the patient visit in the department. The films are then to be read by the Radiologist, to validate the findings. C. Upon identification of an x-ray variance, the Radiologist is to notify the Emergency Department." The procedure section goes on to describe that the ED physician should enter the interpretation into the (PACS) system. If the ED physician fails to do so, then the radiologist will place a variance folder in the PACS system. This did not occur for Patient 16's abdominal X-rays from 4/20/10 according to the radiologist, Physician A, on 6/22/10 at 2:55 PM.
















A "Consultation Note" dated 5/06/10 dictated by Physician F, explained that prior to her anticipated discharge after the first surgery, a subsequent study (gastrografin study; a radio-opaque material is introduced into the stomach and watched on X-ray to detect leaks) showed there was still leakage from the area of rupture and tumor. She subsequently underwent exploratory laparotomy (exploratory surgery of the abdomen, antrectomy (removal of the lower end of the stomach) and gastrojejunostomy (removal of duodenum, the first part of the intestine, and making an opening in the abdominal wall to attach the lower stomach and second part of the intestine to the opening for drainage).

The Discharge Summary, stated the admission date as 4/22/10 and the discharge date as 5/25/10 (slightly more than 4 weeks).

The abdominal X-ray for Patient 16 from 4/20/10 was reviewed in the ED on 6/22/10 at 2:55 P.M. The radiologist (Physician A) who interpreted the X-ray and the acting ED Medical Director for the day (Physician B) were present. The MD surveyor was easily able to identify the free gas in the abdomen below the right diaphragm. Free gas refers to gas or air present in the abdominal cavity, but not in any of the organs. Both physicians were asked if this was a finding that should have been identified by an Emergency Physician reading this film. Both expressed that this would be the expectation. The radiologist stated that he read the film just a few hours after the patient was discharge from the first ED visit. He had assumed (incorrectly) that the treating physicians knew about the free air since he had thought the patient was being admitted. He stated that he should have called the ED physician with this finding. He was questioned about other causes of free air in the abdomen. He stated, unless there had been a recent surgery, free air the abdomen is almost always indicative of a ruptured viscus (hole or rip in the stomach or intestines).

Physician E was the Emergency Medical Physician that cared for Patient 16 during the first ED visit on 4/20/10. She was interviewed by phone on 6/23/10. She recalled the patient, but not the specific X-ray. She thought she might have been rushed and therefore missed the finding of free intraperitoneal (inside the abdominal cavity) gas.

Physician C, the surgeon that performed the procedure to repair the rupture, was interviewed on 6/23/10 at 8:15 AM. He first saw her at the third ED visit. At that time, she was in septic shock (a condition in which the body is overwhelmed with an infection to the point that the patient develops shock). She was "a candidate for immediate surgery." When he opened her abdomen, he found a leak in the area where the duodenum (the first part of the small intestine) connects with the stomach. He repaired the hole. Post-operatively, she had a persistent leak of intestinal contents into the abdomen and was taken for a second surgery. He stated that he removed the area of stomach and duodenum. Physician C stated that the pathology revealed that the ruptured area had been infiltrated by the patient's cancer, in both the stomach and the duodenum. He was asked about the delay in performing surgery from the time the first abdominal X-ray at the first ED visit showed free air in the abdomen and the time at the third ED visit when she presented in sepsis and the leak diagnosed. He stated, "every hour makes a difference," in this situation.

Based on observation, staff interviews and document review, the hospital Food Service Manager failed to ensure the daily management of the dietary service for food safety as specified by the department policies and procedures for food storage.

Findings

During a tour of the kitchen on 6/21/10 at 11:15 AM, the walk-in refrigerator contained 5 boxes, 10 pounds each, of beef cubes labeled keep frozen, with no thaw or use by date written. Also found was a box labeled Chicken Breast Cordon Royale and was also labeled keep frozen, with no thaw or use by date date written.

During a concurrent interview with the chef, he stated that the boxes of beef were to used for beef stroganoff and they had been pulled from the freezer to thaw in the refrigerator. He further stated that both the chicken and the beef should have been dated. He indicated that since the expiration dates for both the products were unknown, they would be discarded.

Review of the "Dating and Labeling Guidelines" policy, undated, on 6/21/10, indicated that, "All food items must be dated and labeled....Food items (must) be labeled with the preparation dated and expiration dates."

During an interview with the FSM (Food Service Manager) on 6/21/10 at 2:40 PM. she stated that it is the food service supervisor's (FSS) responsibility to ensure proper storage of all food items and check all labeling and dating of product in the refrigerators. She further stated that the FSSs complete a daily checklist of duties that include this monitoring of dating products in the refrigerator. She was unable to explain why the AM FSS for that day had not completed his checklist and ensured that the meat was dated.

Based on interview and record review the services provided by Radiology were not fully integrated with the services of the Emergency Department. The policy for communication of discrepancies in the reading of X-ray studies between the ED physician and radiologist was not followed. This resulted in a failure for X-ray findings missed by ED physicians to be communicated to them from the radiologists. This deficient practice resulted in a miscommunication of an X-ray reading that lead to serious injury to Patient 16.

The hospital failed to ensure that emergency services were integrated with other departments of the hospital. A-1103 ?482.55 (a)(2)

The cumulative effect of this systemic failure resulted in the facility's inability to provide emergency services in a safe environment.

Based on interview and document review, the hospital failed to ensure that emergency services were integrated with other departments of the hospital for a universe of potentially any patient who presents to the Emergency department (ED) and requires an X-ray. ED physicians often made preliminary interpretations of X-ray studies. The policy states that a radiologist would review the study later and any discrepancies were to be called to the treating physician. The hospital failed to ensure that a discrepancy in the X-ray readings was called to the treating physician for one of 32 sampled patients, Patient 16, who suffered serious harm as a result.

Findings:

A review of the medical record for Patient 16 revealed that she was a patient with advanced metastatic cancer. The medical record was reviewed extensively on 6/22/10 and 6/23/10. An Emergency Department (ED) record dated 4/20/2010, and timed 3:38 A.M. indicates the patient presented to the ED with abdominal pain. She also complained of nausea. She was evaluated by a physician in the ED and given Dilaudid (a strong pain medicine) and Intravenous (IV) fluid hydration. Various tests were done, including blood chemistry, complete blood count (CBC), an ultrasound of her gallbladder and a 3 view series of X-rays of her abdomen. The ED physician record indicated that abdominal X-rays were normal ("nl" was checked). The patient did have gallstones on ultrasound. The patient was discharged at 6:40 A.M., feeling somewhat better to follow-up with her physician in 1-2 days. The Imaging Report for the abdominal series of X-rays was interpreted by Radiologist, Physician D, at 11:16 A.M. on that same day. The first paragraph of the report states "Gas is identified underneath the right hemidiaphragm (right half of diaphragm muscle) consistent with free intraperitoneal gas. (Gas in the abdominal cavity, not inside any of the organs) If the patient has not had a recent surgical procedure, perforated viscus (rupture of stomach or intestine) should be considered."

The record of a second ED visit was reviewed. The visit occurred on 4/20/10 at 8:12 AM (one and half hours since the previous ED discharge). A review of the record from the second ED visits revealed that the patient's chief complaint was chest pain. Another ED medical provider evaluated the patient, had her take antacids, and pain medication. A ventilation/perfusion scan was performed. This is a test to identify pulmonary embolism (large blood clots in the arteries of the lungs). This was negative. Several other tests were performed. There is no evidence that the X-rays from the previous visit were reviewed. There was no indication that the misread on the X-ray had been communicated to the ED physicians from the Radiology Department. The patient was discharged at 2:00 P.M.

The third ED visit occurred on 4/21/10 at 12:58 P.M. (23 hours after discharge from the second ED visit. A review of the record from the patient's third visit revealed that the patient arrived by ambulance. The chief complaint was pain in the right upper part of the abdomen. She had visited her primary doctor, and fainted in his office. She had a low blood pressure, was diaphoretic (cold sweat). Her blood pressure continued to drop in spite of multiple therapeutic measures, suggesting the patient was in shock. The ED physician's examination showed her to have a diffusely tender abdomen. Under the X-ray section of the record is the entry "CT Ap-perf viscus, met breast. This ment that a CT (CAT scan) scan was done to rule out appendicitis, and instead, a perforated viscus was seen, suspected to be due to metastatic breast cancer. A surgeon was consulted urgently.

A History and Physical typed report was dictated by Physician E on 4/22/10. This record was reviewed and revealed that this was the admission to the ICU after the surgery. In the assessment area, the following diagnoses relevant to the investigation are listed; acute respiratory failure, status post exploratory laparotomy, septic shock, acute peritonitis (inflammation of the lining of the abdomen), multiple intra-abdominal abscesses (pockets of infection), ruptured duodenal ulcer, and extensive necroses (tissue death) of gastric and surrounding tissue.

A Consultation Note dated 5/6/10 was dictated by Physician F, and explained that prior to her anticipated discharge after the first surgery, a subsequent study (gastrografin study; a radio-opaque material is introduced into the stomach and watched on X-ray to detect leaks) showed there was still leakage from the area of rupture and tumor. She subsequently underwent exploratory laparotomy (exploratory surgery of the abdomen, antrectomy (removal of the lower end of the stomach) and gastrojejunostomy (removal of duodenum, the first part of the intestine, and making an opening in the abdominal wall to attach the lower stomach and second part of the intestine to the opening for drainage).

The Discharge Summary, documented the admission date as 4/22/10 and the discharge date as 5/25/10 (slightly more than 4 weeks).

The abdominal X-ray for Patient 16 from 4/20/10 was reviewed in the ED on 6/22/10 at 2:55 P.M. The radiologist (Physician A) who interpreted the X-ray and the acting ED Medical Director for the day (Physician B) were present. The MD surveyor was easily able to identify the free gas in the abdomen below the right diaphragm. Free gas refers to gas or air present in the abdominal cavity, but not in any of the organs. Both physicians were asked if this was a finding that should have been identified by an Emergency Physician reading this film. Both expressed that this would be the expectation. The radiologist stated that he read the film just a few hours after the patient was discharge from the first ED visit. He had assumed (incorrectly) that the treating physicians knew about the free air since he had thought the patient was being admitted. He stated that he should have called the ED physician with this finding. He was questioned about other causes of free air in the abdomen. He stated, unless there had been a recent surgery, free air the abdomen is almost always indicative of a ruptured viscus (hole or rip in the stomach or intestines).

Physician C, the surgeon that performed the procedure to repair the rupture, was interviewed on 6/23/10 at 8:15 AM. He stated that he first saw her at the third ED visit. At that time, she was in septic shock (a condition in which the body is overwhelmed with an infection to the point that the patient develops shock). He stated that she was "a candidate for immediate surgery." When he opened her abdomen, he found a leak in the area where the duodenum (the first part of the small intestine) connects with the stomach. He repaired the hole. Physician C stated that post-operatively, she had a persistent leak of intestinal contents into the abdomen and was taken for a second surgery where he removed the area of stomach and duodenum. He stated that the pathology revealed that the ruptured area had been infiltrated by the patient's cancer, in both the stomach and the duodenum. Physician C was asked about the delay in performing surgery from the time the first abdominal X-ray at the first ED visit showed free air in the abdomen and the time at the third ED visit when she presented in sepsis and the leak diagnosed. He stated, "every hour makes a difference," in this situation.

The Medical Director of the ED (Physician D) was interviewed 6/23/10 at 10:12 A.M. He was asked about when the error in the reading of the abdominal X-ray was recognized. He answered that it was at the time of the patient's third visit to the ED when it was obvious the patient needed surgery. The X-ray was reread by the treating physician in the ED and the diagnosis of a ruptured viscus was made.

Physician E was the Emergency Medical Physician that cared for Patient 16 during the first ED visit on 4/20/10. She was interviewed by phone on 6/23/10. She recalled the patient, but not the specific X-ray. She thought she might have been rushed and therefore missed the finding of free intraperitoneal (inside the abdominal cavity) gas.