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FAITH REGIONAL HEALTH SERVICES 2700 WEST NORFOLK AVE NORFOLK, NE 68701 March 12, 2018
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review of 5 patients who had mammogram screening exams (an exam used to aid in the diagnosis of [DIAGNOSES REDACTED]. The Radiology Director and Risk Manager failed to ensure an incident report was completed and failed to notify anyone in the Quality Assurance Department that an adverse patient event had occurred to ensure the facility could promptly analyze the causal factors and implement changes to protect patients and prevent further errors. The facility conducted 388 screening mammogram's in December 2018, 255 in January 2018 and 228 in February 2018. These patients were all at risk of incurring a delay in treatment from receiving the wrong result letter and/or their provider failing to receive a timely report to make treatment decisions. The total sample was 12. The facility inpatient census was 61.

Findings are:

A. Electronic Medical Record review for Patient 8 revealed the patient had received a bilateral mammogram screening exam at the facility which was ordered by Physician Assistant (PA) "A". Record review of the Radiologist report dictated 11/16/17 (and transcribed the same day) was signed by Radiologist "B". The report notes "There has been significant change from the previous mammogram dated May 31, 2016." Under the area titled "Impression/Assessment" the report documented "BI-RAD category 4: Suspicious of malignancy." (BI-RAD is a breast imaging-reporting and data system used for mammography to standardize reporting by medical professionals to communicate a patient's risk of developing [DIAGNOSES REDACTED] where 1 is negative and 6 is a proven malignancy). The report noted under "Follow Up Recommendations" - "Histology [microscopic analysis] using core biopsy -stereotactic right breast." (Stereotactic is a sample that is taken for analysis that is minimally invasive using a 3 dimensional coordinated system to locate small areas in the breast for biopsy).

B. Staff Interview with the Director of Radiology on 3/8/18 at 10:30 AM revealed the facility OMNI Care mammography program uses input from the mammography technician to generate a letter to the patient based on the Radiologists report. The Director stated that Mammography Technician C sent the letter to the patient 11/16/17 informing them the exam was normal and no additional follow up was needed until their next yearly screen. Also on 11/16/17 the Radiologist report was faxed to the practitioner PA A. The Director said that once a month the mammography staff print a report of the yearly reminders to patients and the short term follow up if a patient needed further testing such as Patient 8. The facility did not run the report in December due to high volume of mammogram's and ran the report around 1/15/18. If they have not received any follow up information on patients with recommended follow up testing they call the provider to see if it was done. On 1/29/18 they called PA A and found the PA never received the report from the Radiologist. Follow up with the Information Technology (IT) staff at the hospital on [DATE] found that the fax machine used to fax the report failed to send it.

C. Interview with the Risk Manager on 3/12/18 at 1:20 PM revealed the Manager was notified 1/29/18 by a Cancer Center employee (who was a friend of Patient 8) that the patient had received the wrong mammography letter. The employee told the Risk Manager that the Patient was upset about a mammogram that was misread or misnotified of the results. The Risk Manger called the Radiology Manager and after reviewing the record called Patient 8. Patient 8 was informed that she received the wrong letter. She was told a staff member pushed a button for a "normal" letter when it was actually "abnormal" which caused the wrong letter to be sent to the patient. They also disclosed that the provider did not receive the report due to a fax error. The Risk Manager stated that in reviewing what happened this was a "system error and a human error". The Risk Manager identified this as an Adverse Patient Event." The Manager confirmed an incident report was not made of the incident. The Risk Manager stated he/she is responsible for ensuring a 3 M (facility incident report system) report is completed for all Adverse Patient Events and it was not. Quality Assurance staff are notified of errors via the incident report system and direct notification by staff. The Risk Manager stated that the Radiology Manager was looking at processes and the recovery call was made to the patient. The Risk Manager confirmed Quality Assurance staff were not notified of this adverse patient event involving system and human error.

C. Interview with the Director of Quality and Risk Manager on 3/12/18 at 1:20 PM revealed the Quality Department became aware of the incident with Patient 8 on 2/26/18 when they received a complaint from the insurance company of Patient 8. The Director of Quality met with the Radiology Manager that day. A Root Cause Analysis was scheduled for 3/8/18 when all involved could be present. The Radiology staff and IT had implemented some short term action plans.
- On 1/31/18 IT turned on a feature of the fax report to identify if it was successfully sent and notified staff to attach it to the report. Radiology reviewed reports after November 2018 to ensure no other errors in reports/letters and found none.
- On 2/23/18 the Radiology Manager sent an email to IT requesting having a dictation area next to the Radiology viewing station.
- On 3/1 the OmniCare system support staff, Radiologists and the hospital IT started working on setting up a test environment to test the flow of BI-RAD codes, breast density and recommendations. Information flow integration between the hospital EMR system of Sorian, Syngo (Radiology Information System), and OmniCare (the mammogram software system. The goal to integrate the systems so dictated reports auto send to the prescriber.
- On 3/9/18 after the RCA additional education was provided to the mammography technicians regarding attaching the successfully sent copies; the chain of command; the need to double check with second technologist to ensure the BI-RAD coding and radiology dictation matches the printed letter to the patient and the faxing of the report to the practitioner. The file for call backs will be done monthly to ensure patients have scheduled the recommended follow up appointment. If no follow up is scheduled a letter is sent to the provider. Patients are encouraged to use the patient portal to look for their test results. Education was done for providers to use the physician portal so they can get the results and less error with faxing being sent and received. A Quality Audit was initiated 3/10/18 of 10 random Mammogram patients records for each year since 2015. The Audit reviewed whether the letters sent to the patient matched up to the reports. No errors were found.

D. Record review of facility policy titled "Occurrences, Near Misses and Sentinel Events: Reporting and Response" last revised 2/2015 identifies a Sentinel Event as "An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The risk thereof signals the need for immediate investigation and response." Failure to send Patient 8 the correct letter notifying her of the abnormal mammogram, need for follow up testing, and failure to notify the provider that the mammogram was suspicious of a malignancy allowed a potential cancer to grow untreated from 11/16/17 until the patient provider notification on 1/29/18. The facility identifies the Root Cause Analysis (RCA) as a step by step questioning process to identify the contributing causal factors of an error, near miss, never event, or sentinel event. The initial RCA meeting "must be done as quickly as possible with all staff from the time of the event, or from the time of being aware of the event." The RCA identifies "process changes that must occur to prevent a future sentinel event." Staff failed to complete a timely incident report or to notify the Quality Director that an error had occurred with Patient 8 even though the Radiology staff had identified a system error and a human error. This failure prevented system or human errors to be fully analyzed and action plans developed and monitored to ensure a similar error will not reoccur.