Summary:
Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the AAB-Medical Laboratory Evaluation (AAB-MLE) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 1/3/2024, the laboratory failed to maintain satisfactory performance in two of three testing events (2023-Event 1 and 2023-Event 3) resulting in unsuccessful participation for TOTAL BILIRUBIN. Refer to D2096. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from AAB-Medical Laboratory Evaluation (AAB-MLE) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 1/3/2024, the laboratory failed to achieve satisfactory performance for TOTAL BILIRUBIN in two of three testing events. Findings include: A review of the laboratory records from the AAB-Medical Laboratory Evaluation (AAB-MLE) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for TOTAL BILIRUBIN: TOTAL BILIRUBIN: Year 2023- 1st Event 60% Year 2023-3rd Event 20% -- 2 of 2 --