Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 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 a routine proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Association of 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 -- Biolanalysts Medical Laboratory Evaluation (AAB-MLE) 2025, 2026 records, the laboratory failed to successfully participate in proficiency testing for D(RHO) analyte and ABO/RHO subspecialty resulting in an initial unsuccessful participation. Refer to D2162 and D2163. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) (f) Failure to achieve satisfactory performance for the same analyte 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 a routine proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Association of Biolanalysts Medical Laboratory Evaluation (AAB-MLE) 2025, 2026 records, the laboratory failed to achieve satisfactory performance scores for D(RHO) in two out of three consecutive testing events (event 3 in 2025 and event 1 in 2026). Findings include: 1. A review of the CASPER 0155D report on 4/13/2026 at 1:00 PM revealed the D(RHO) score for PT event 3 in 2025 was 0%, and the score for PT event. 2. A review of the AAB-MLE 2025 and 2026 records on 4/14/2026 at 10:00 AM confirmed that the D(RHO) score for PT event 3 in 2025 was 0%, and the score for PT event 1 in 2026 was 60%. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) (g) Failure to achieve an overall testing event score of satisfactory for 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 a routine proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Association of Biolanalysts Medical Laboratory Evaluation (AAB-MLE) 2025, 2026 records, the laboratory failed to achieve satisfactory performance scores for overall ABO/RHO proficiency testing event for two out of three consecutive testing events (event 3 in 2025 and event 1 in 2026). Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on 4/13/2026 at 1:00 PM revealed the ABO/RHO overall score for PT event 3 in 2025 was 0%, and the score for PT event 1 in 2026 was 60%. 2. A review of the AAB-MLE 2025 and 2026 records on 4/14/2026 at 10:00 AM confirmed that the ABO/RHO overall score for PT event 3 in 2025 was 0%, and the score for PT event 1 in 2026 was 60%. -- 2 of 2 --