Summary:
Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 15, 2026. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the CASPER 155 report and review of the Wisconson State Laboratory of Hygenene (WSLH) proficiency testing (PT) reports, the laboratory 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 -- failed to maintain satisfactory PT participation for the subspeciality of Mycology (2025 events 1 & 3 and 2026 event 1) resulting in non-initial unsuccessful participation for DTM , in the Subspeciality of Mycology. Refer to D 2046 D2046 MYCOLOGY CFR(s): 493.827(e) (e) Failure to achieve an overall testing event score of satisfactory performance 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of WSLH reports, the laboratory failed to maintain satisfactory participation in three of four PTevents ( 2025 events 1 & 3 and 2026 event 1), resulting in non-initial unsuccessful participation for DTM , in the Subspeciality of Mycology. Findings: 1. A review of the Casper Report 155 revealed the laboratory failed Mycology/DTM on the following: 2025 Event 1 Mycology/DTM Score 0% 2025 Event 3 Mycology/DTM Score 0% 2026 Event 1 Mycology/DTM Score 0% 2. A review of the laboratory's WSLH Reports confirmed the laboratory failed the above scores. 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 review of the CMS CASPER 155 report and review of the WSLH PT reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required for DTM , in the Subspeciality of Mycology. Refer to D6016, D6019 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 review of the CMS CASPER Report 155 and the WSLH (2025 events 1 & 3, and 2026 event 1) PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in three of four testing events (2025 events 1 & 3, and 2026 event 1) resulting in the non-initial unsuccessful participation for DTM , in the Subspeciality of Mycology. D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved