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 conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting 0155 (CASPER 0155) report, American Proficiency Institute (API) proficiency testing (PT) 2025 and 2026 records, and staff interview, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events for the subspecialty of Endocrinology for the analyte T3 Uptake. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a proficiency testing desk review of the CASPER 0155 report, the laboratory's API PT 2025 and 2026 records, and staff interview, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte for two consecutive PT testing events in the subspecialty of Endocrinology for the T3 Uptake analyte. The findings included: 1. Review of CASPER 0155 revealed the following results: 2025 3rd Event: The laboratory received an unsatisfactory score of 40% for T3 Uptake. 2026 1st Event: The laboratory received an unsatisfactory score of 60% for T3 Uptake. 2. A review of the laboratory's API proficiency testing records for Chemistry - Core 2025 Event Three and 2026 Event One confirmed the laboratory received the above results. 3. The Laboratory Director confirmed receipt of the above results during a virtual meeting held on March 30, 2026, at 9:00 a.m. 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 proficiency testing desk review of CASPER 0155 report, the laboratory's API 2025 and 2026 PT records, and staff interview, the laboratory director failed to provide overall management and direction of laboratory services. The laboratory director failed to ensure proficiency testing 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 a proficiency testing desk review of CASPER 0155 report, a review of the laboratory's API 2025 and 2026 PT records (Chemistry - Core, 2025 Event Three and 2026 Event One), and staff interview, the laboratory director failed to ensure -- 2 of 3 -- proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2016 and D2107. -- 3 of 3 --