Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory policy, American Association of Bioanalysts (AAB) proficiency testing (PT) records and confirmed in interview, the laboratory failed to test proficiency testing materials the same number of times as patient samples for CBC (complete blood count) on the Beckman Coulter ACT Diff 2 hematology analyzer. Findings were: 1. Review of he Beckman Coulter ACT Diff 2 Special Procedures and Troubleshooting manual under the service and maintenance chapter, table 6.4 stated, "X flag indicates that one of the multiple Aperture Alert criteria was not met" and the suggested action was, "1. Thoroughly mix and rerun the samples. 2. If flag does not repeat, report result. 3. If flag repeats, clean the aperture as instructed in Zapping the Aperture. 4. If after cleaning, problem Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- persists, contact your Beckman Coulter Representative." 2. Review of the Beckman Coulter's Act Diff 2 analyzer's Operators manual (PN 4237495B, June 2003) revealed in the Service and Maintenance chapter is a section titled "Parameter Codes and Flags." The manufacturer's instructions stated "If any flag appears, review the results according to your laboratory's protocol." The following flags also include the following instructions: "3" = Differential parameter failed the internal regional size distributional criteria at region 3. Action = Verify results according to laboratory's protocol. "M" = Differential parameter failed the internal regional size distributional criteria at multiple regions. Action = Verify results according to laboratory's protocol. "L" = Low result. For Patient samples, result is lower than the low limit for that patient sample. Action = Follow the laboratory's protocol. "H" = High result. For Patient samples, the result is higher than the upper limit for that patient sample. Action = Follow the laboratory's protocol. "*" = If on WBC (white blood count) and Differential only, 35 fL (fluid level)' count interference check failed. Possible interference with the WBC count. Action = Thoroughly mix and rerun the sample. = Verify results according to your laboratory's protocol. 3. Review of the laboratory policy ZMC002 Coulter Act 2Diff revealed "results that contain error codes or are above the instrument linear limits are repeated. If the second run duplicates errors send samples to the reference laboratory for confirmatory analysis...some error codes may be eliminated by cleaning the instrument. See the operator's manual for instructions. "*" review results; mix and repeat "X" aperture alert: clean and repeat analysis. Send for confirmation if requested by clinician. "1,2,3,4,M" differential parameters failed the internal regional size distribution criteria in one or more regions: repeat analysis. If the error code persists and the clinician requests the sample will be sent for confirmation. 4. Review of the 2017 - 2018 AAB Hematology proficiency test records revealed no documentation of the repeat analysis for the CBCs with flags for 6 of 6 testing events: 2017 3rd event, Specimen 2 (*), 3 (*), 4 (*), 5 (*) 2017 2nd event, Specimen 2 (*) ,4 (*) , 5 (*) 2017 1st event, Specimen 1 (*), 2 (*), 3 (*), 4 (*), 5 (*) 2018 3rd event, Specimen 12 (M, *), 13 (*), 14 (M,*) 2018 2nd event, Specimen 7 (*), 10 (*) 2018 1st event, Specimen 1 (*), 3 (*), 4 (*), 5 (*) 5. Interview with the primary test person on 3/19/19 at 1330 hours in the laboratory confirmed the above findings. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Bioanalysts Association (AAB) Chemistry proficiency testing records from 2017 and 2018, and confirmed in interview, the laboratory failed to attain a satisfactory score of at least 80% for the analyte Total Bilirubin (Tbili), Carbon Dioxide (CO2), and Uric Acid (UA). The findings were: 1. A review of the laboratory's AAB proficiency test records from 2017 and 2018 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analytes Tbili on 1 of 5 events: 2017 Event 3 Tbili (20%) lab result acceptable result Specimen 1 1.8 2.4 - 3.6 Specimen 2 2.2 3.1 - 4.7 Specimen 3 0.9 1.0 - 1.8 Specimen 5 1.6 2.1 - 3.2 2. A review of the laboratory's AAB proficiency test records from 2017 and 2018 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analytes CO2 on 1 of 5 events: 2018 Event 2 CO2 (40%) lab result acceptable result Specimen 1 19 21 - 32 Specimen 2 15 16 - 24 Specimen 4 12 13 - 21 -- 2 of 12 -- 3. A review of the laboratory's AAB proficiency test records from 2017 and 2018 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analytes Uric Acid on 1 of 5 events: 2018 Event 2 UA (60%) lab result acceptable result Specimen 2 4.9 3.4 - 4.8 Specimen 4 4.2 2.8 - 3.9 4. An interview with the primary testing person on 3/19/19 at 1315 hours in the laboratory confirmed the above findings. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory American Association Bioanalysts (AAB) proficiency testing records, laboratory policy, and confirmed in interview, the laboratory failed to document remedial action for PT failures for the analyte Total Bilirubin (Tbili), Carbon Dioxide (CO2), and Uric Acid (UA). Findings were: 1. A review of the laboratory's AAB from 2017 and 2018 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analytes Total Bilirubin (Tbili), Carbon Dioxide (CO2), and Uric Acid (UA). Cross refer to D2087 2. Review of the laboratory policy Laboratory Proficiency Testing revealed "all results less than 100% must be investigated and remediated appropriately." 3. Review of the laboratory