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 company. The facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES of the CLIA program: D2016 - 42 C.F.R. 493.803 Condition: Successful participation 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 proficiency testing desk review of Centers for Medicare and Medicaid Services (CMS) 0155 report and American Association of Bioanalysts (AAB) 2025 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 -- proficiency testing (PT) records, the laboratory failed to successfully participate in Routine Chemistry for the Prostate Specific Antigen (Total) analyte for two of three events in 2025 (Events 2 and 3), resulting in an initial PT failure. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 proficiency testing desk review of Centers for Medicare and Medicaid Services (CMS) CASPER 0155 report and American Association of Bioanalysts (AAB) 2025 proficiency testing (PT) records, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) in Routine Chemistry for the Prostate Specific Antigen (Total) analyte for two of three events in 2025 (Events 2 and 3), resulting in an initial PT failure. Findings included: 1. Review of the CASPER 0155 report revealed the following results: a. Routine Chemistry 2025-Second Event: Laboratory received an unsatisfactory score of 20% for the Prostate Specific Antigen, Total analyte. b. Routine Chemistry 2025-Third Event: Laboratory received an unsatisfactory score of 0% for Prostate Specific Antigen, Total analyte. 2. Review of the AAB Proficiency Testing records confirmed the laboratory received the above results in Routine Chemistry, for two of three proficiency testing events in 2025 (Events 2 and 3), resulting in an initial PT failure. 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 proficiency testing desk review of Centers for Medicare and Medicaid Services (CMS) CASPER 0155 report and American Association of Bioanalysts (AAB) 2025 proficiency testing (PT) records, the laboratory director failed to provide overall management and direction in accordance with 493.1445 of this subpart. The laboratory director failed to ensure overall management of the laboratory for one of one moderate complexity specialty performed (routine chemistry). 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 proficiency testing desk review of Centers for Medicare and Medicaid Services (CMS) CASPER 0155 report and American Association of Bioanalysts -- 2 of 3 -- (AAB) 2025 proficiency testing (PT) records, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of three testing events in Routine Chemistry for Prostate Specific Antigen, Total in 2025 (Events 2 and 3) resulting in an initial PT failure. Refer to D2096. -- 3 of 3 --