[117722810]
On tuesday, (b)(6) 2018, during review of method validation studies comparing the current beckman chemistry analyzer, at (b)(6), with the soon to go-live new beckman coulter analyzer, it was noticed that the reporting units for urinary microalbumin coming directly from both the current and yet to be implemented analyzer were different than the units currently being reported in (b)(4) (laboratory information system; lis). The current analyzer appeared to be reporting units in mg/dl while (b)(4) was currently posting the results and reference range in mg/l. An investigation was started and was led by our lab medical director ((b)(4), md) and supported by our lab and imaging director ((b)(4)), lab coordinator (b)(4) and lab technical consultant (b)(4). Following investigation and testing with the (b)(4), we confirmed that current urinary microalbumin values being reported in mg/dl from the analyzer were being directly reported in (b)(4) as mg/l without a conversion. Reference range values for urinary microalbumin were also reported in mg/l as opposed to mg/dl. The combination of these factors resulted in the reported values being interpreted as 10 fold lower than those reported from the instrument. In addition, there is a calculation reported with every urinary microalbumin value termed urinary microalbumin to creatinine ratio (mcr) which is reported as mg albumin to g creatinine (mg/g). Creatinine is reported in mg/dl. Due to microalbumin reporting in (b)(4) as mg/l, this calculation was being reported 10 fold lower than the actual value. We suspended microalbumin testing on (b)(6) 2018 after the investigation was completed. We sent all microalbumin tests to our reference lab for testing until the identified unit conversion error was corrected and we had confirmed through in-house testing that microalbumin values were being accurately reported in (b)(4). We ran reports to identify the patients and providers requiring notification. On 04/20/2018, we notified providers of the situation with a list of their affected patients. In addition, on 05/05/2018 we sent a letter of explanation directly to all patients affected over the last two years. We also corrected reports in the lis and sent these corrected reports to the ordering providers. We conducted our root cause analysis on 04/20/2018. The participants included the following: lab medical director ((b)(4), md), lab and imaging director (b)(4), lab coordinator (b)(4)), lab technical consultant (b)(4), president (b)(4)), vp of finance and operations (b)(4), vp, senior physician executive ((b)(4), md) and vp of nursing and patient care services (b)(4). The rca resulted in discovery of a shift in results in (b)(6) 2007. Further investigation identified an insurance claim for damage to lab equipment due to a lightning storm. Beckman was notified to confirm service at that time but was unable to research as their system was upgraded in 2008 and they do not have the records before the upgrade. We were able to learn from another lab site that they also had this issue on their beckman analyzer following service after a lightning storm. Beckman came on site to change the analyzer reporting to mg/l on 04/24/2018. Blind specimens were run on our analyzer and then also on the reference lab analyzer for correlations. The instrument print out showed the proper unit of measure of mg/l, correlating with the (b)(4) report. Reports and print outs were reviewed by the medical director and urine microalbumin testing was re-implemented (b)(6) 2018. Please discuss any interaction with the vendor and whether this concern is broader than your organization. The laboratory coordinator, (b)(4), contacted beckman customer support on 04/06/2018 inquiring of any changes affecting microalbumin unit of measure since 2008. They could not find anything in their system and closed our ticket. (b)(4), beckman capital equipment consultant, came onsite on monday (b)(6) to introduce our new service representative, (b)(4). We explained our findings and ongoing investigation at that time. We communicated that we were aware of a similar situation at another beckman site and would need beckman's help in researching service records to identify where and when the change in unit of measure occurred. We requested a contact within the service department and a contact within leadership for our president (b)(4) to speak with. After the internal rca identified the error most likely occurred on (b)(6) 2007, email and phone communications occurred between lab and imaging director (b)(4) and beckman capital equipment consultant (b)(4) for assistance with further investigation. (b)(4) forwarded our request for service records from 2007 to (b)(4), beckman district service manager. (b)(4) was able to discover. Beckman changed systems in 2008 for service records and without a serial number she could not track anything before that time. Direct communications with (b)(4) confirmed this finding on june 13, 2018. At that time, an additional request was made to speak with someone within leadership at beckman. (b)(4) responded he would set up a conference call for us. We have not had a conference call with beckman to date. On june 15, 2018 lab coordinator (b)(4) and lab director (b)(4) received a request from beckman northeast service manager/director national service support (b)(4), for additional information on the incident. (b)(4) shared what we had for correlation information when the dxc 600 was installed to assist his research. (b)(4) and (b)(4) spoke later that day to further discuss the situation and our exact request. (b)(4) was able to find the serial number of the previous analyzer and did not believe we would have service records but would check for us. He did not believe there would be anything beckman did to change the unit of measure and the site would be responsible for doing any verifications if we thought something may not be correct. He would look into it further and get back to us with his findings. There has been no further communication or follow up at this time and we have findings. There has been no further communication or follow up at this time and we have not received a contact for president (b)(4) to speak with. Summary of concerns. Concern that the beckman coulter analyzer may have reverted to the factory settings after lightning strike. Concern that this was potentially a known issue by beckman coulter and was not widely communicated. Concern that there is no industry standard measure for utilizing milligrams per liter (mg/l) or milligrams per deciliter (mg/dl).
Patient Sequence No: 1, Text Type: D, B5