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Tag No.: A0115
Based on interview and record review, the Condition of Participation: Patient Rights was not met as evidenced by a failure to inform a patient of the complete results of a CT Scan (computerized tomography). This failure to provide complete information regarding the patient's health status prevented potential options for further diagnosis and treatment from being initiated in a timely manner.
Refer to Tag: A-131
Tag No.: A0131
Based on staff interview and record review, the hospital failed to assure the rights of a patient were met due to a failure to inform a patient of the complete results of a CT Scan (computerized tomography). This failure to provide complete information regarding the patient's health status prevented potential options for further diagnosis and treatment from being initiated in a timely manner for 1 applicable patient. ( Patient #1)
On 3/24/14 Patient #1 presented to the Emergency Department (ED) with a complaint of left lower quadrant abdominal pain. Treatment included IV (intravenous) hydration, pain medication and a CT Scan of the patient's abdomen and pelvis. The indication to perform this test was to determine if the patient was experiencing symptoms related to diverticulitis (an inflammation or infection in the lining/bulging sacs of the large intestine). At 1:06 PM the radiologist electronically signed the dictated CT scan report. The radiologist's report states: "Impression: Findings consistent with acute diverticulitis.....". This report became available within minutes for ED physician #1's review. At 2:12 PM the radiologist electronically signed a dictated "Addendum Report" which states: "Further evaluation of the kidneys reveal that there is indeed a left renal mass measuring 4.3 cm in size....this appearance of a solid renal mass is highly suspicious for a renal cell carcinoma. When the patient's condition permits further evaluation including consideration of biopsy and resection recommended with urologic consultation". The radiologist further documents s/he discussed the findings with ED physician #1. Patient #1 was discharged home at on 3/24/14 at 13:57 from the ED with a prescription for antibiotics and instructions for managing symptoms and diet associated with the diverticulitis. Per review of the "Physician Clinical Report" for 3/24/14 ED physician #1's fails to document Patient #1 was informed of the Addendum Radiology Report. Referrals were not suggested or provided to Patient #1 to follow-up with a urologist.
On 3/27/14 at approximately 14:15 ED physician #1 notes a follow-up phone call transpired between the physician and Patient #1. ED physician #1 was informed by the patient that their symptoms were almost as bad as they were on 3/23/14. Patient #1 was advised to return to the ED, which s/he did at 16:44 on 3/27/14. Subsequently, due to significant ongoing symptoms for diverticulitis was admitted to surgical services on observation status and IV fluids and antibiotics were initiated. Patient #1 was discharged on 3/28/17.
On 9/20/16 Patient #1 presents to the ED with a chief complaint of hematuria (blood in urine). Patient #1 had been scheduled to follow-up with urology in weeks prior to this ED visit for ongoing hematuria but per ED physician #2, the appointment fell through. After the exam and review of laboratory results, Patient #1 was discharged home with instructions to follow-up with a urologist. On 9/28/16 Patient #1 again returns to the ED. Complaints included: hematuria and urinary retention. The patient reported unwanted weight loss and was experiencing moderate pain in the lower abdomen. A CT Scan was ordered of the abdomen and pelvis. Findings included: "Kidneys: The previous noted heterogeneous mass in the left kidney has enlarged and now occupies majority of the kidney sparing the upper lobe...."
In addition an exam of the lungs noted "Multiple lung metastases". The radiologist notes: " Dr. XXXX was informed of these results at the time of interpretation". ED physician #2 informed Patient #1 of the findings and "...concern for renal cell carcinoma..." Patient #1 was admitted to the hospital on 9/28/16. On 9/30/16 a left nephrectomy (removal of kidney) was performed and on 10/4/16 Patient #1 was discharged.
Per interview on 3/20/17 at 3:10 PM the hospital's Chief Medical Officer (CMO) stated s/he was appraised by a hospitalist involved in Patient #1's care during hospitalization on 9/28/16 - 10/4/16 of the failure to inform Patient #1 of the initial findings from the CT Scan conducted on 3/24/14. Shortly after the patient was discharged, the CMO requested to meet with Patient #1. At this meeting the CMO provided Patient #1 with full disclosure regarding the failure of ED physician #1 to notify Patient #1 on 3/24/14 of the initial radiology impression of a renal mass.
In addition, further opportunity was missed for informing Patient #1 of the renal cell mass during the second ED visit and hospitalization 3/27/14 - 3/28/14. The radiological report was available but was not identified for further review within the Electronic Medical Record by ED Physician #1 or other medical staff involved with Patient #1's hospitalization. This failure prevented Patient #1 from being fully informed of his/her health status and opportunity to seek consultation and potential treatment. The 4.3 cm left renal mass identified on 3/24/14 had grown to 8 x 7 x 10 cm, per CT Scan comparison. On 9/28/16 Patient #1 was diagnosed with Stage IV renal call cancer and treatment was determined to be palliative.
Tag No.: A0263
Based on interview and record review the Condition of Participation: Quality Assurance/Performance Improvement was not met due to the failure to assure that its program activities included a timely and complete review and analysis of an adverse event and the causes, and failed to develop and implement hospital wide preventive actions to assure that adverse events will not recur.
Refer to Tag: A-286
Tag No.: A0286
Based on staff interview and record review, the hospital's Quality Assurance/Performance Improvement failed to assure that its program activities included a timely and complete review and analysis of a critical adverse event and the causes, and failed to develop and implement hospital wide preventive actions to assure that a similiar patient adverse event could not recur. ( Patient #1) Findings include:
Per interview on 3/20/17 at 3:10 PM the hospital's Chief Medical Officer (CMO) stated s/he was appraised by a hospitalist involved in the care of Patient #1 who was hospitalized on 9/28/16 through 10/4/16 of the failure to inform the patient of the initial findings from a CT Scan conducted on 3/24/14. Shortly after the patient was discharged, the CMO requested to meet with the patient. At this meeting the CMO provided the patient with full disclosure regarding the failure of ED physician #1 to notify the patient on 3/24/14 of the initial radiology impression of a left renal mass noted during a CT Scan of the patient's abdomen and pelvis. In addition, further opportunity was missed for informing Patient #1 of the renal cell mass during a second ED visit and hospitalization 3/27/14 - 3/28/14. The Diagnostic Imaging report was available but was not identified for further review within the Electronic Medical Record by ED Physician #1 or other medical staff involved with Patient #1's hospitalization. This failure prevented Patient #1 from being fully informed of his/her health status and opportunity to seek consultation and potential treatment. The 4.3 cm left renal mass identified on 3/24/14 had enlarged to 8 x 7 x 10 cm, per CT Scan comparison. On 9/28/16 Patient #1 was diagnosed with Stage IV renal call cancer and treatment was determined to be palliative. The CMO stated a confidential Peer review conducted by selective medical staff had been initiated in October 2016, however this review remained ongoing and as of 3/21/17 a final determination of the above mentioned event has not been finalized.
Per interview on the afternoon of 3/20/17, the Executive Director of Quality, Utilization & Care Management stated the "event" involving the CT Scan report and failure to inform Patient #1 of the results back in September 2014 was a "M.D. handoff issue.......". Since learning of the event in September 2016, no Root Cause Analysis (RCA) has been conducted upon learning of the adverse patient event. The Director further stated the adverse event can be partially associated with the ongoing problems and challenges of the Electronic Medical Record (EMR), but was waiting to hear the results of the Peer review before further analysis of possible causes would be initiated.
Per interview on 3/21/17 at 8:00 AM, the Director of Health Information Management stated s/he had not been asked to review how "Addendums" are reviewed in the EMR. The opportunity to "look" at workflow and possibly put something in place such as "flag/alert" when an addendum is added to the EMR, has not been discussed. The Director further stated "We have to figure something out".
Per interview on 3/20/17 at 1:25 PM Radiologist #1, explained s/he is a contracted employee of Dartmouth Hitchcock Medical Center (DHMC) employed full time at Brattleboro Memorial Hospital (BMH). Radiologist #1 confirmed s/he reported the "Addendum Impression" to ED physician #1 on 3/24/14 and received a verbal acknowledgement from ED physician #1 when informed of the findings. Radiologist #1 stated s/he now receives a report from (DHMC) bi-weekly which identifies "unexpected findings" associated with Diagnostic Imaging results/interpretations conducted by the radiologists at BMH. This Quality process (which was not available in 2014) is now part of the Radiology/Imaging contract associated with DHMC who also assist on nights and weekends by providing radiology interpretations remotely. Once received, the "unexpected findings" are reviewed by Radiologist #1, who notifies the BMH ordering/referring provider to ensure there is follow-up with the patient related to an "unexpected finding".
However, per interview on 3/21/17 at 10:00 AM the Director of Cardiovascular Services and Imaging was unaware of the DHMC "unexpected findings" report received and monitored by Radiologist #1. In addition, the Director had not been made aware of the adverse event discovered in September 2016. Reflecting on potential options to prevent a similar adverse event from occurring, the Director suggested preventive measures could include requesting DHMC to generate a daily list of "unexpected findings" which could be monitored electronically on a spread sheet. This could assist in confirming the referring provider and patient had been made aware of the "unexpected findings". The Imaging Manager also confirmed on 3/21/17 at 10:05 AM, s/he had not been made aware of the adverse patient event identified in September/2016. The Manager oversees the Quality Assurance/Performance Improvement for Diagnostic Imaging but had not been approached to review and suggest possible preventative action to further improve communication and "Addendum" process. The Manager also provided a tracking log s/he utilizes for "Critical Test Results" for Diagnostic Imaging. This process also ensures physicians are contacted within 1 hour by a radiologist of a critical Diagnostic Imaging interpretation which could immediately impact a patient's health (ex.: Acute intracranial bleed, Aortic rupturing aneurysm).
During a follow-up interview on 3/21/17 at 4:00 PM, the Executive Director of Quality acknowledged a lack of a hospital-wide system review of the patient adverse event incident. The Director was unaware of the QA/PI program utilized by Diagnostic Imaging, related to "unexpected findings" reports received from DHMC. It was also confirmed there was a failure to interview individuals whose departments were associated with the event and who may have been able to assist in the implementation of preventative action when first acknowledged in September/ 2016. Six months after the disclosure to Patient #1 of the delayed diagnosis of Renal Cell Cancer, a corrective plan has not been developed to ensure this significant adverse patient event is not repeated.