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 following conditions of the CLIA program: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting 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 -- Bioanalysts - Medical Laboratory Evaluation, the laboratory failed to successfully participate in an approved PT program for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of hematology for erythrocytes. Refer to D2130. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and the proficiency testing (PT) cumulative scores report from American Association of Bioanalysts - Medical Laboratory Evaluation (AAB- MLE), the laboratory failed to achieve satisfactory performance for erythrocytes in two consecutive PT events. Findings: 1. Review of the CASPER 0155D report showed that the laboratory received the following unsatisfactory scores for erythrocytes: a. 40% in the 2025 1st PT Event b. 60% in the 2025 2nd PT Event 2. Review of the AAB-MLE cumulative scores report confirmed the CASPER 0155D report results. 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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting 0155D report and American Association of Bioanalysts - Medical Laboratory Evaluation, the laboratory director failed to ensure PT samples were tested as required. 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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting 0155D report and American Association of Bioanalysts - Medical Laboratory Evaluation, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an approved PT program. Refer to D2130. -- 2 of 2 --