Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, AAB-MLE (American Association of Bioanalysts Medical Laboratory Evaluation). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based for the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation, proficiency testing 493.1403 Laboratory Director, Moderate Complexity 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 a desk review of proficiency testing records, the laboratory failed to 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 -- successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in two of three hematology proficiency testing events for the red blood cell (RBC) analyte. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a proficiency testing desk review of the CASPER- 0155 Individual Laboratory Report obtained from the CMS national database and AAB-MLE 2025 (1st and 3rd events) records, the laboratory failed to achieve satisfactory performance (100%) for the same analyte in two out of three consecutive testing events in the specialty of hematology for the RBC analyte. Two of three consecutive unsatisfactory scores result in unsuccessful PT performance. The findings include: 1. Review of the CASPER- 0155 report revealed the following: RBC 2025 - 1st Event Laboratory received an unsatisfactory score of 60% RBC 2025 - 3rd Event Laboratory received an unsatisfactory score of 40% 2. A proficiency testing desk review from AAB-MLE 2025 proficiency testing records confirmed the above findings. Word Key: CASPER- Certification and Survey Provider Enhanced Reporting CMS- Centers for Medicare and Medicaid AAB-MLE- American Association of Bioanalysts Medical Laboratory Evaluation RBC- red blood cell D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance, it was determined that the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory failed to successfully participate in two of three hematology proficiency testing events for the red blood cell (RBC) count analyte. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was determined that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS -- 2 of 3 -- approved proficiency testing program. The laboratory failed to successfully participate in two of three hematology proficiency testing events for the red blood cell (RBC) count analyte. Refer to D2130. -- 3 of 3 --