Los Angeles Hematology

Summary Statement of Deficiencies 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 Surveyor review of laboratory's proficiency testing (PT) result evaluation from American Proficiency Institute (API) and interview with the laboratory technical consultant on November 10, 2021 at 12:34 pm, the laboratory failed to attain a score of at least 80 percent of acceptable responses for Chloride, Potassium and Sodium at the 1st event of 2021. The findings include: 1. The laboratory performed Chloride, Potassium and Sodium testing using an automated ACE Axcel instrument. To verify its test accuracy, the laboratory participated in API PT testing for the year of 2021. However, it received a score of 60% and 40% for Chloride and Potassium/Sodium, respectively at the 1st event resulting in an unsatisfactory analyte performance for the event. Therefore, the failure in the PT event suggesting that the patients' Chloride, Potassium and Sodium results reported during the PT event period might had not been accurate and thus causing patient harm. 2. The laboratory technical consultant on November 10, 2021 at 12:34 pm, affirmed that the laboratory had received a score of 60% and 40% for Chloride and Potassium/Sodium, respectively at the 1st event. 3. The laboratory's testing declaration form, signed by the laboratory Director on 11/10 /2021, stated that the laboratory performs approximately 2,820 (each) Chloride, Potassium and Sodium tests, annually. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 Surveyor review of laboratory's proficiency testing (PT) results from American Proficiency Institute (API), remedial action documentation and interview with the laboratory technical consultant on November 10, 2021 at 12:34 pm, the laboratory failed to take an appropriate remedial action after obtaining an unsatisfactory analyte performance for Chloride, Potassium and Sodium at the 1st event of 2021. The findings include: 1. The laboratory performed Chloride, Potassium and Sodium testing using an automated ACE Axcel instrument. To verify its test accuracy, the laboratory participated in API PT testing for the year of 2021, and obtained an unsatisfactory analyte performance at the 1st event for Chloride, Potassium and Sodium. Therefore, the failure in the PT event suggesting that the patients' Chloride, Potassium and Sodium results reported during the PT event period might had not been accurate and thus causing patient harm. However, the laboratory did not investigate any effect on patient care during that PT period. 2. The laboratory technical consultant on November 10, 2021 at 12:34 pm, affirmed that the laboratory's remedial action plan was not available. 3. The laboratory's testing declaration form, signed by the laboratory Director on 11/10/2021, stated that the laboratory performs approximately 2,820 (each) Chloride, Potassium and Sodium tests, annually. D5783

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: 1. Based on interview with the Technical Consultant on 03/26/19, review of the laboratory's proficiency testing records from the 1st testing event of 2017 through the 3rd proficiency proficiency testing event of 2018, it was determined that the laboratory failed to verify the accuracy of its Free Testosterone assay, at least twice a year. The findings included: a. In 2017 and 2018, the laboratory had elected to enroll in proficiency testing as its means of verifying the accuracy of the Immulite 2000 (SN# J4129) Free Testosterone assay performed, which is not included under subpart I of this part of CLIA. b. A review of the performance summary report provided to the laboratory by its proficiency testing provider, American Proficiency Institute (API), showed the laboratory obtained unsatisfactory scores for the 1st proficiency testing events of 2017 and 2018, constituting failure to verify the accuracy of the Free Testosterone, at least twice a year. Testing Event Analyte Score Q1 2017 Free Testosterone 0% Q1 2018 Free Testosterone 67% c. The laboratory tested and reported Free Testosterone results for the following five patient samples: Date tested Accession #s 03/08/2018 96348 03/26/2018 96786 04/04/2018 97108 05/08/2018 98128 09/20/2018 101617 d. The laboratory staff affirmed (03/2 6/20 19 at approximately 11:00 a.m.) the laboratory failed to verify the accuracy of its Free Testosterone assay, at least twice a year. 2. Based on interview with the Technical Consultant on 03/26/19, review of the laboratory's proficiency testing records from the 1st testing event of 2017 through the 3rd proficiency proficiency testing event of 2018, it was determined that the laboratory failed to verify the accuracy of its Parathyroid Hormone (PTH) assay, at least twice a year. The findings included: a. In 2017 and 2018, the laboratory had elected to enroll in proficiency testing as its means Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- of verifying the accuracy of the Immulite 2000 (SN# J4129) PTH performed, which is not included under subpart I of this part of CLIA. b. A review of the performance summary report provided to the laboratory by its proficiency testing provider, American Proficiency Institute (API), showed the laboratory obtained unsatisfactory scores for the 1st proficiency testing event of 2017 and 2nd proficiency testing event of 2018, constituting failure to verify the accuracy of the PTH, at least twice a year. Testing Event Analyte Score Q1 2017 PTH 67% Q2 2017 PTH 33% c. The laboratory tested and reported PTH results for the following six patient samples: Date tested Accession #s 04/10/2018 97241 04/17/2018 97452 04/23/2018 97655 05/01/2018 97886 05/08/2018 198128 05/10/2018 98212 d. The laboratory staff affirmed (03/2 6 /20 19 at approximately 11:30 a.m.) the laboratory failed to verify the accuracy of its PTH assay, at least twice a year. 3. Based on interview with the technical consultant on 03/26/19, review of the laboratory's proficiency testing records from the 1st testing event of 2017 through the 3rd proficiency proficiency testing event of 2018, it was determined that the laboratory failed to verify the accuracy of its Erythrocyte Sedimentation Rate (ESR) assay, at least twice a year. The findings included: a. In 2017 and 2018, the laboratory had elected to enroll in proficiency testing as its means of verifying the accuracy of the Dispette3 ESR assay performed, which is not included under subpart I of this part of CLIA. b. A review of the performance summary report provided to the laboratory by its proficiency testing provider, American Proficiency Institute (API), showed the laboratory obtained unsatisfactory scores for the 2nd and 3rd proficiency testing events of 2017, constituting failure to verify the accuracy of the ESR, at least twice a year. Testing Event Analyte Score Q2 2017 ESR 50% Q3 2017 ESR 50% c. The laboratory tested and reported ESR results for the following nine patient samples: Date tested Accession #s 07/12/2017 88985 07/12/2017 88987 07/12/2017 88989 07/12/2017 88997 07/12/2017 89002 07/12/2017 88991 07/12 /2017 88994 11/16/2017 92753 11/16/2017 92759 d. The laboratory staff affirmed (03 /2 6/20 19 at approximately 1:00 p.m.) the laboratory failed to verify the accuracy of its ESR assay, at least twice a year. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel reports (CMS209, LAB116) and documents for annual competency assessment, the lack of laboratory documents, and interview with laboratory personnel, the Technical Consultant failed to evaluate the performance of Testing Person for Erythrocyte Sedimentation Rate (ESR) at least semiannually during the first year of testing, and annually thereafter . Findings included: a. Documents for 2018 annual competency assessment were provided for the testing person named on the laboratory personnel reports. b. The laboratory failed to provide document(s) for competency assessment for the testing person performing ESR utilizing Dispette3 at least semiannually during the first year, and annually thereafter. c. The reliability and quality of results reported could not be assured when competency was not assessed and documented at least semiannually during the first year of testing, and annually thereafter. Examples of ESR testing performed by Testing Person in 2017 are as follows: Date tested Accession #s 07/12/2017 88985 07 /12/2017 88987 07/12/2017 88989 07/12/2017 88997 07/12/2017 89002 07/12/2017 -- 2 of 3 -- 88991 07/12/2017 88994 11/16/2017 92753 11/16/2017 92759 d. The laboratory person affirmed (03/26/19 at approximately 1:00 p.m.) the lack of aforementioned semiannual competency assessment for the testing person performing ESR and thus, the failure of the Techical Consultant to evaluate and document testing performance at least semiannually during the first year, and annually thereafter. -- 3 of 3 --