Lawrence-Douglas County Health Dept

Summary Statement of Deficiencies 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 proficiency testing (PT) records, the laboratory failed to successfully participate in PT from the Wisconsin State Laboratory of Hygiene (WSLH) for the regulated analyte Bacteriology. See D2028. D2028 BACTERIOLOGY CFR(s): 493.823(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of PT records on August 6, 2021 revealed the laboratory failed to successfully participate in PT from WSLH for the regulated analyte Bacteriology. Findings include: 1. First event 2021 revealed a score of 0% for Bacteriology. 2. Second event 2021 revealed a score of 60% for Bacteriology. Phone interview with the on-site laboratory manager on 8/6/21 at 12:45 p.m. confirmed laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events for the regulated analyte Bacteriology. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) documentation and interview with the Technical Consultant (TC)#1, the laboratory failed to test the 2018-2019 testing event microbiology samples the same number of times that it routinely tests patient samples. Findings Include: 1. Review of the laboratory's PT WSLH documentation for the 2nd testing event of 2018 and the 1st and 2nd testing events of 2019 in the specialty of microbiology found that each proficiency testing samples for gram stains were read by two different personnel. 2. The TC#1 confirmed that it is not routine laboratory practice for a patient's sample to be reevaluated after the first evaulation by a different TP. The TC#1 stated they were unable to provide any laboratory policies or procedures that stated patient samples would be handled in a manner similar to the testing process described above. The interview occurred 10/10/2019 @10 A.M. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) documentation and interview with technical consultant #1, the laboratory failed to document all proficiency testing evaluation and verification 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 -- activities. Findings Include: 1. Review of the laboratory's WSLH PT documentation found the laboratory's received a score of "Unacceptable" on the follow PT samples: WSLH PT 2018 BactiReg2 Gram Stain Morphology GS-08 No documentation of