Summary:
Summary Statement of Deficiencies D0000 An offsite revisit survey was conducted on 08/05/2024 for all previous deficiencies cited on 04/23/2024. All deficiencies have been corrected. The laboratory is in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). -------------------------------------------- An announced survey of the laboratory was conducted on 04/23/2024. 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. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 2 of 3 consecutive testing events in 2023 resulting in unsuccessful performance. The laboratory did not successfully participate in PT for the specialty of Chemistry, analyte Sodium. Refer to D2096. 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 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 2023 PT events, the 2023 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 2023 revealed the laboratory received a score of 0% for the following analytes for 2023 Chemistry - Core - 3rd Event: Albumin BNP (B-Type Natriuretic Peptide) Calcium, Total Chloride CO2 (Carbon Dioxide) Creatinine Kinase, Isoenzyme Creatinine D-Dimer Glucose Lactic Acid Magnesium Myoglobin Phosphorus Potassium Sodium Troponin 1 Urea Nitrogen 2. In an interview on 04/23/2024 at 1105 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 prior to the programs deadline. This confirmed the findings. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 2 of 3 consecutive proficiency testing (PT) events for the specialty Chemistry, analyte Sodium (Na). 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 2 out of 3 consecutive testing events with a score of less than 80% for the Sodium analyte: 2023 Chemistry - Core - 2nd Event: Analyte: Sodium Score: 60% 2023 Chemistry - Core - 3rd Event: Analyte: Sodium Score: 0% 2. In an interview on 04/23/2024 at 1105 hours in the breakroom, the laboratory's Technical Consultant (as indicated on submitted Form CMS 209) confirmed the findings. -- 2 of 6 -- D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) 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 4 of 4 analytes in 17 PT events reviewed 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