Summary:
Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) from Wisconsin State Laboratory of Hygiene (WSLH) 1st and 2nd Events of 2025, the laboratory failed to meet the following conditions, resulting in initial unsuccessful PT participation: D2016 - 42 CFR 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 CFR 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 (PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D , and 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 -- phone conversation with the laboratory director (LD) revealed the laboratory had unsuccessful participation for two consecutive testing event for the specialty hematology. 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 Proficiency Testing (PT) desk review of the Wisconsin State Laboratory & Hygiene (WSLH) performance summary results, review of the Casper report 0155D, and phone interview with the laboratory director (LD), the laboratory had unsuccessful performance in two (2) consecutive testing events for the following analytes in hematology in 2025. Findings include. 1. WSLH 1st event 2025 a) White Blood Cell = 60% 2. WSLH 2ndevent 2025 a) White Blood Cell = 40% 3. Casper Report 1055D 1st event 2025 a) White Blood Cell = 60% 4. Casper Report 0155D 2nd event 2025 a) White Blood Cell = 40% 5. Phone interview with the LD on 08/26 /2025 at 12:20 PM confirmed these findings. 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 (PT) desk review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing results, review of the Casper Report 0155D, the laboratory director (LD) failed to provide overall management and direction to the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. 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 CASPER 0155D report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency summary report of 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency program. Refer to D2130. -- 2 of 2 --