Kansas City Skin & Cancer Center

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of proficiency testing (PT) records, the laboratory fails to test proficiency testing samples in the same manner as patient's specimens. See D2006. This laboratory was previously cited for failure to test proficiency testing samples in the same manner as patient's specimens under D2015 on 8/23/2019. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. 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 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) documentation and interview with the general supervisor (GS) #2, the laboratory failed to examine or test, as applicable, the proficiency testing samples in the same manner as it tests patient specimens. This occurred for four of four PT testing events in 2020 and 2021. Findings: 1. Review of the laboratory's 2020 and 2021 WSLH PT documentation found Potassium Hydroxide (KOH) prep PT samples tested in multiples as follows: a. 2020 Micro QA1: Result pages showed testing was performed by two testing personnel for three of three samples: Slide 1, Slide 2, and Slide 3 on the same date of 4/16/2020. The attestation page has signatures for three testing personnel. Submission of PT results cuttoff date was 5/1/2020. b. 2020 Micro QA2: Result pages showed testing was performed by five testing personnel for three of three samples: Slide 4, Slide 5, and Slide 6 on 10/15 /2020 and 10/16/2020. All five testing personnel signed the attestation page. Submission of PT results cuttoff date was 10/30/2020. c. 2021 Micro QA1: Result pages showed testing was performed by four testing personnel for three of three samples: Slide 1, Slide 2, and Slide 3 on 4/15/2021 and 4/16/2021. All four testing personnel signed the attestation page. Submission of PT results cuttoff date was 4/30 /2021. d. 2021 Micro QA2: Result pages showed testing was performed by four testing personnel for three of three samples: Slide 4, Slide 5, and Slide 6 on 10/21 /2021 and 10/22/2021. The attestation page has signatures for two testing personnel. Submission of PT results cuttoff date was 10/29/2021. 2. GS #2 stated the laboratory does not have more than one testing personnel perform patient testing for KOH exams. Interview on 11/30/21 at 1:20 p.m. with GS #2 confirmed, the laboratory failed to examine or test, as applicable, the proficiency testing samples in the same manner as it tests patient specimens. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of WSLH Proficiency testing (PT) during calendar year 2018 and 2019, the laboratory failed to document the proficiency testing samples were handled in the same manner as patient samples. Findings were: A. A review of proficiency testing events during 2018-2019 revealed that the laboratory failed to handle proficiency testing samples in the same manner as patients. During the review, the surveyor found multiple testing of the proficiency testing prior to the submission date of the proficiency events. The Kansas City Skin & Cancer Center's proficiency testing policy states" the proficiency testing will be treated exactly as patient samples, from accessioning through reporting. Tests will be repeated only patient samples would be repeated under the same conditions." B. The testing events reviewed were: WSLH PT 2018-SPMicro-A1-A and WSLH PT 2019-SPMicro-A1 C. The interview with the Laboratory director at 1100 hours confirmed that routinely patient testing would be performed by one testing personnel prior to resulting. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --