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Based on interview and a review of facility documentation, the facility failed to ensure that equipment in the form of the ADAC Skylight Imaging System camera, used within the Diagnostic Imaging department, was tested in an accurate manner in accordance with policy and manufacturer specifications.

Findings:

An interview was performed with the Administrator on 1/29/13, beginning at approximately 9:45 PM. The Administrator provided the surveyor a copy of an e-mail titled "Investigation Report on (name of the Lead Nuclear Medicine Technologist)", dated 1/25/13, authored by the Director of Diagnostic Imaging. The report read, "On Wednesday, January 16th, (subordinate Nuclear Medicine Technologist who reported to the Lead) .... came into my office stating that (the Lead Nuclear Medicine Technologist) falsified the QA (Quality Assurance) on the Nuclear Medicine camera on 12/31/2012."

The Administrator indicated at the above time that in response to this news, the contractor Masterplan was contacted to verify the subordinate Nuclear Medicine Technologist's (NMT) claims (this contact was also reflected in the document). The document continued, "On Friday, January 18th, the Masterplan Biomedical Technician came in to look at the acquisition station." Per interview of the Director of Diagnostic Imaging, on 1/19/13 at approximately 10:30 AM, the "acquisition station" is a work station which is attached to the above-mentioned diagnostic imaging camera. He stated that it retains recent images and their corresponding dates and times. The document continued, "The pictures of what he saw are attached, which is the images were obtained on 1/10/13 and date changed to 12/31/12." Per interview of the Director of Diagnostic Imaging at the above stated time, this statement is a reference to the weekly "BARS" test (a test for image resolution. "BARS" is a reference to bar shapes that are used in a flat, square plate which is scanned by the nuclear medicine camera). He stated that this test is done on a weekly basis and can be performed at any time during a designated week. He further stated that the last quoted sentence, above, means that the BARS test was physically finalized on 1/10/13, but was falsely documented as having been performed on 12/31/12, for the week of 12/30/12 - 1/5/13. The e-mail document continued, "On Thursday, January 24th, (a Certified Nuclear Medicine Technologist) who now works in IT (Information Technology) was called in to look at the suspicion of the falsification of QA (Quality Assurance). He found the actual image acquisition ....confirms that the QA images were taken on 1/10/13 and put in file folder dated 12/31/12 and put in PACS (Picture Archives Communication System) for archive." This further attests to the falsification mentioned above.

A screenshot was reviewed and confirmed that the weekly BARS designated in the system for the time period of 12/30/12-1/05/13 was given the name of "12/31/12" (which would have been a suitable name for the week's date range), but was actually created on 1/10/13. In addition, examination of the screenshot for a log of images revealed that no images whatsoever were taken on 12/31/12.

Another document derived from the acquisition station showed that images were taken on 1/10/13 at 8:14 AM and labeled 12/31/12. The e-mail document continued, "On Friday, January 25th, (the consultant Radiological Physicist), came and looked at the data on 12/31/12 and 1/10/13. He concluded in his report that the falsification of QA data was accurate....On Friday, January 25th, I pulled the time record for all three Nuclear Medicine Technologists' in Kronos....The only technologist that was working during the time the falsification (8:14 AM on 1/10/13, see prior text) of the QA took place was (the Lead NMT, mentioned previously)"

Regarding the above mentioned physicist report, it read, "Careful analysis of data, in support of the Technologist's formal report, seems to indicate that the test results were not completed during the required week and that additional images were obtained the following week and substituted back into the previous week."

Thus, the facility concluded in the face of evidence from different sources that a specific employee had attributed recently acquired Quality data regarding the functioning of a diagnostic camera to an earlier date, committing an act of falsification.

Additional details into the preceding incident were obtained from the Director of Diagnostic Imaging at the above stated time. He stated that it is their protocol for weekly BARS for them to be done at any time during a designated week. He said investigation had revealed that the Lead NMT did three of eight required BARS on 12/30/12, but physically finished the remaining five on 1/10/13 (labeling them 12/31/12) which was outside of the week's time limits. He stated that the Lead NMT had essentially performed the bulk of the BARS outside of the approved time window of 12/30/12 - 1/5/13 and actually back dated it.

Per interview with the Director of Diagnostic Imaging on 1/30/13 at 9:40 AM, he stated that with respect to the nuclear medicine camera, it is a ADAC Skylight, manufactured by Phillips. Essentially, patients are injected with radio isotopes, placed on a flat table and scanned by the camera which detects the radioactive material. It is used to detect and/or diagnose various medical conditions.

A review of manufacturer's "Skylight Imaging System User's Manual" revealed the following with respect to BARS: "Test the image resolution weekly to ensure that certain detector electronic circuits are working properly. Although you can perform this test intrinsically or extrinsically, Phillips recommends an intrinsic test because collimator artifacts (aliasing) can occur with extrinsic testing." The manual continued with specific instructions.

During an interview of the Director of Diagnostic Imaging on 1/30/13 at 9:48 AM, he confirmed that the testing for BARS essentially involves the placement of a special plate with a design array of bars in various orientations before the camera for scanning and interpretation by the camera's detectors.

A review of the facility's document "Medical Equipment Management Plan" revealed the following: "The Biomedical Engineer coordinates the evaluation of all equipment used for the diagnosis, treatment, and monitoring of patients to determine the appropriate maintenance strategy, thus assuring safety and maximum useful life. The strategy selected is based on manufacturer recommendations, accreditation or regulatory requirements, local operating experience and equipment design ." Thus, follow manufacturer's recommendations. In view of the preceding information from the manufacturer and facility policy, the previously confirmed input of falsified data pertained to a maintenance practice which is expected to be performed in order to help ensure optimum patient care.

In view of the preceding, the occurrence of the falsification of data concerning a required maintenance task on patient care equipment was a violation of the integrity of the maintenance system as established in the facility.

During an interview of the Administrator on 1/30/13 at approximately 2 PM, he confirmed the findings.

Based on interview and a review of facility documentation, the facility failed to ensure that equipment in the form of the ADAC Skylight Imaging System camera, used within the Diagnostic Imaging department, was tested in an accurate manner in accordance with policy and manufacturer specifications.

Findings:

An interview was performed with the Administrator on 1/29/13, beginning at approximately 9:45 PM. The Administrator provided the surveyor a copy of an e-mail titled "Investigation Report on (name of the Lead Nuclear Medicine Technologist)", dated 1/25/13, authored by the Director of Diagnostic Imaging. The report read, "On Wednesday, January 16th, (subordinate Nuclear Medicine Technologist who reported to the Lead) .... came into my office stating that (the Lead Nuclear Medicine Technologist) falsified the QA (Quality Assurance) on the Nuclear Medicine camera on 12/31/2012."

The Administrator indicated at the above time that in response to this news, the contractor Masterplan was contacted to verify the subordinate Nuclear Medicine Technologist's (NMT) claims (this contact was also reflected in the document). The document continued, "On Friday, January 18th, the Masterplan Biomedical Technician came in to look at the acquisition station." Per interview of the Director of Diagnostic Imaging, on 1/19/13 at approximately 10:30 AM, the "acquisition station" is a work station which is attached to the above-mentioned diagnostic imaging camera. He stated that it retains recent images and their corresponding dates and times. The document continued, "The pictures of what he saw are attached, which is the images were obtained on 1/10/13 and date changed to 12/31/12." Per interview of the Director of Diagnostic Imaging at the above stated time, this statement is a reference to the weekly "BARS" test (a test for image resolution. "BARS" is a reference to bar shapes that are used in a flat, square plate which is scanned by the nuclear medicine camera). He stated that this test is done on a weekly basis and can be performed at any time during a designated week. He further stated that the last quoted sentence, above, means that the BARS test was physically finalized on 1/10/13, but was falsely documented as having been performed on 12/31/12, for the week of 12/30/12 - 1/5/13. The e-mail document continued, "On Thursday, January 24th, (a Certified Nuclear Medicine Technologist) who now works in IT (Information Technology) was called in to look at the suspicion of the falsification of QA (Quality Assurance). He found the actual image acquisition ....confirms that the QA images were taken on 1/10/13 and put in file folder dated 12/31/12 and put in PACS (Picture Archives Communication System) for archive." This further attests to the falsification mentioned above.

A screenshot was reviewed and confirmed that the weekly BARS designated in the system for the time period of 12/30/12-1/05/13 was given the name of "12/31/12" (which would have been a suitable name for the week's date range), but was actually created on 1/10/13. In addition, examination of the screenshot for a log of images revealed that no images whatsoever were taken on 12/31/12.

Another document derived from the acquisition station showed that images were taken on 1/10/13 at 8:14 AM and labeled 12/31/12. The e-mail document continued, "On Friday, January 25th, (the consultant Radiological Physicist), came and looked at the data on 12/31/12 and 1/10/13. He concluded in his report that the falsification of QA data was accurate....On Friday, January 25th, I pulled the time record for all three Nuclear Medicine Technologists' in Kronos....The only technologist that was working during the time the falsification (8:14 AM on 1/10/13, see prior text) of the QA took place was (the Lead NMT, mentioned previously)"

Regarding the above mentioned physicist report, it read, "Careful analysis of data, in support of the Technologist's formal report, seems to indicate that the test results were not completed during the required week and that additional images were obtained the following week and substituted back into the previous week."

Thus, the facility concluded in the face of evidence from different sources that a specific employee had attributed recently acquired Quality data regarding the functioning of a diagnostic camera to an earlier date, committing an act of falsification.

Additional details into the preceding incident were obtained from the Director of Diagnostic Imaging at the above stated time. He stated that it is their protocol for weekly BARS for them to be done at any time during a designated week. He said investigation had revealed that the Lead NMT did three of eight required BARS on 12/30/12, but physically finished the remaining five on 1/10/13 (labeling them 12/31/12) which was outside of the week's time limits. He stated that the Lead NMT had essentially performed the bulk of the BARS outside of the approved time window of 12/30/12 - 1/5/13 and actually back dated it.

Per interview with the Director of Diagnostic Imaging on 1/30/13 at 9:40 AM, he stated that with respect to the nuclear medicine camera, it is a ADAC Skylight, manufactured by Phillips. Essentially, patients are injected with radio isotopes, placed on a flat table and scanned by the camera which detects the radioactive material. It is used to detect and/or diagnose various medical conditions.

A review of manufacturer's "Skylight Imaging System User's Manual" revealed the following with respect to BARS: "Test the image resolution weekly to ensure that certain detector electronic circuits are working properly. Although you can perform this test intrinsically or extrinsically, Phillips recommends an intrinsic test because collimator artifacts (aliasing) can occur with extrinsic testing." The manual continued with specific instructions.

During an interview of the Director of Diagnostic Imaging on 1/30/13 at 9:48 AM, he confirmed that the testing for BARS essentially involves the placement of a special plate with a design array of bars in various orientations before the camera for scanning and interpretation by the camera's detectors.

A review of the facility's document "Medical Equipment Management Plan" revealed the following: "The Biomedical Engineer coordinates the evaluation of all equipment used for the diagnosis, treatment, and monitoring of patients to determine the appropriate maintenance strategy, thus assuring safety and maximum useful life. The strategy selected is based on manufacturer recommendations, accreditation or regulatory requirements, local operating experience and equipment design ." Thus, follow manufacturer's recommendations. In view of the preceding information from the manufacturer and facility policy, the previously confirmed input of falsified data pertained to a maintenance practice which is expected to be performed in order to help ensure optimum patient care.

In view of the preceding, the occurrence of the falsification of data concerning a required maintenance task on patient care equipment was a violation of the integrity of the maintenance system as established in the facility.

During an interview of the Administrator on 1/30/13 at approximately 2 PM, he confirmed the findings.