Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted 04/13/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 a review of laboratory policy, laboratory proficiency testing records, and confirmed in an interview, the laboratory failed to test proficiency testing samples in the same manner as it tests patient specimens for four of nine events reviewed, for chemistry core and hematology/coagulation, in 2022 and 2023. The findings included: 1. Review of the laboratory policy titled "Proficiency Testing Performance and Review", section "Policy" had the following statement: "2. As closely as is practical, recognizing that some special handling may be required due to the nature of proficiency testing materials, proficiency survey analysis is performed in the same manner as regular patient samples." 2. Review of the laboratory policy titled "Critical Laboratory Values", section "Policy" had the following statement: "Any test performed in-house that demonstrates a critical value should be called to the immediate attention of the clinician after the result(s) have been verified by testing personnel by repeat testing." 3. Review the laboratory's established critical values and the proficiency testing records for Chemistry and Hematology / Coagulation 2022 and 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 -- the Chemistry Core 1st event of 2023, which had the following critical values with no documentation of verification through repeat testing: 2022 Chemistry Core 2nd Event Sample - Analyte - Reported Result - Laboratory's Critical Criteria CH-07 - Glucose - 47 mg/dL - Less than 54 mg/dL CH-06 - Potassium - 6.6 mmol/L - Greater than 6.0 mmol/L CH-07 - Potassium - 2.8 mmol/L - Less than 3.0 mmol/L CH-10 - Potassium - 6.4 mmol/L - Greater than 6.0 mmol/L 2022 Hematology / Coagulation 2nd Event Sample - Analyte - Reported Result - Laboratory's Critical Criteria COU-08 - Hemoglobin - 6.8 g/dL - Less than 7 grams/dL 2022 Hematology / Coagulation 3rd Event Sample - Analyte - Reported Result - Laboratory's Critical Criteria COU-12 - Hemoglobin - 18.1 g/dL - Greater than 18 grams/dL COU-14 - Hemoglobin - 6.7 g/dL - Less than 7 grams/dL 2023 Chemistry Core 1st Event Sample - Analyte - Reported Result - Laboratory's Critical Criteria CH-01 - CO2 - 14 mmol/L - Less than 15 mmol /L CH-03 - Sodium - 173 mmol/L - Greater than 160 mmol/L 4. In an interview on 4 /13/2023 at 1035 hours, in the office, the technical consultant confirmed that verification of critical results had not been performed for the above proficiency testing records. D5783