Summary:
Summary Statement of Deficiencies D0000 An announced validation survey of the laboratory was conducted on 05/22/2024. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 42 C.F.R. 493.807 (a) - Reinstatement after failure 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to achieve successful performance for 3 of 3 consecutive testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- events in 2022 and 2023 resulting in unsuccessful performance. The laboratory did not successfully participate in PT for the specialty of Hematology, White Blood Cell Differential. Refer to D2130. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records for 2022 and 2023, and staff interview, the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program for 1 of 3 PT events from 2022, the 2022 Chemistry - Core - 3rd Event, resulting in an unsatisfactory performance for the event. Findings included: 1. Review of laboratory's American Proficiency Institute PT records for 2022 and 2023 revealed the laboratory received a score of 0% for the following analytes for 2022 Chemistry - Core - 3rd Event: Albumin Alcaline Phosphatase ALT/SGPT Amylase AST/SGOT Bilirubin, Total BNP (CM) Calcium, Total Chloride CO2 (Carbon Dioxide) Creatinine Kinase, CK Creatinine Kinase, Isoenzyme Creatinine D-Dimer Glucose Myoglobin Phosphorus Potassium Sodium Total Protein Troponin 1 (CM) Urea Nitrogen/BUN Uric Acid 2. In an interview on 05/22/2024 at 1100 hours in the breakroom, the laboratory's Technical Consultant (as indicated on submitted Form CMS 209) stated that the score was a result of non-submission of results. This confirmed the findings. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records from 2022 and 2023, and staff interview, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 3 of 3 consecutive proficiency testing (PT) events for the specialty Hematology, White Blood Cell Differential. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings included: 1. A review of the laboratory's American Proficiency Institute PT records from 2022 and 2023 revealed the following consecutive testing events with a score of less than 80% for the White Blood Cell Differential: 2022 Hematology/Coagulation - 2nd Event: Analyte: White Blood Cell Differential Score: 67% 2022 Hematology/Coagulation - 3rd Event: Analyte: White Blood Cell Differential Score: 27% 2023 Hematology/Coagulation - 1st Event: Analyte: White Blood Cell Differential Score: 20% 2. In an interview on 04/23/2024 at 1100 hours in the breakroom, the laboratory's Technical Consultant (as indicated on submitted Form CMS 209) confirmed the findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) -- 2 of 5 -- The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to document evaluation of "Not Graded" results for 2 of 30 reviewed Troponin results in 6 Chemistry - Core PT events from 2022 and 2023. Findings included: 1. Review of laboratory's PT records revealed the laboratory used American Proficiency Institute (API) as its PT provider. Review of API's instructions revealed: "Laboratories are responsible for documenting and performing