Summary:
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 review of proficiency testing records and interview with Technical Supervisor A (TS-A), the testing personnel and Laboratory Director (LD) or designee failed to sign the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing attestation statements for 7 of 7 proficiency testing events. Findings: Review of the WSLH proficiency testing records for Blood Lead for years 2019, 2020 and 2021 revealed the following: 2019 Event 1 - WSLH attestation statement signed by testing personnel but no signature of LD/designee 2019 Event 2 - WSLH attestation statement signed by testing personnel but no signature of LD/designee 2019 Event 3 - WLSH attestation statement not signed by testing personnel or LD/designee 2020 Event 1 - WLSH attestation statement not signed by testing personnel or LD/designee 2020 Event 2 - WLSH attestation statement not signed by testing personnel or LD /designee 2020 Event 3 - WLSH attestation statement not signed by testing personnel or LD/designee 2021 Event 1 - WSLH attestation statement signed by testing personnel but no signature of LD/designee During interview on the afternoon of May 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 -- 18, 2021, TS-A confirmed the WSLH Blood Lead proficiency testing attestation statements are not routinely signed by the testing personnel and the LD/designee. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: I. Based on review of Emergency Response Branch (ERB) competency records and staff interview, the Technical Supervisor failed to evaluate and document the semi- annual competencies within the first year of patient testing for all new testing personnel since the last survey. Findings: 1. A review of ERB competency records revealed that seven of seven new testing personnel the General Supervisor not the Technical Supervisor documented the performance and evaluation of semi-annual competencies within the first year. 2. A review of the Administrative Competency Assessment document for the Technical Supervisor/Branch Chief document states "Reviews competency assessment for testing personnel conducted by general supervisor". 3. An interview of the ERB Technical Supervisor on 5/18/2021 at 1: 00pm confirmed the Technical Supervisor do not perform competency assessment. 27526 II. Based on review of competency assessment records and interview with laboratory staff, Technical Supervisor A (TS-A) and Technical Supervisor B (TS-B) failed to perform semi-annual competency assessments (CA) for testing personnel for years 2018, 2019 and 2020. Findings: TS-A is the only Technical Supervisor for the Inorganic and Radiation Analytical Toxicology Branch (IRATB). Testing personnel A (TP-A), Testing personnel B (TP-B), Testing personnel C (TP-C) and Testing personnel (TP-D) perform CLIA laboratory testing in IRATB. TP-A's semi-annual CA dated 2-1-2019 and 7-24-2019 were not performed by TS-A. TP-B's semi-annual CA dated 3-26-2020 and 3-1-2021 were not performed by TS-A TP-C's semi-annual CA dated 8-6-2019 and 2-6-2020 were not performed by TS-A. TP-D's semi-annual CA dated 3-21-2018 and 9-13-2018 were not performed by TS-A. During interview on the afternoon of May 19, 2021, TS-A confirmed he did not perform the semi- annual CA for TP-A, TP-B, TP-C and TP-D. TS-B is the only Technical Supervisor for the Organic Analytical Toxicology Branch (OATB). Testing personnel E (TP-E), testing personnel F (TP-F), testing personnel G (TP-G) and testing personnel H (TP- H) perform CLIA laboratory testing in OATB. TP-E's semi-annual CA dated 4-26- 2019 and 10-11-2019 were not performed by TS-B. TP-F's semi-annual CA dated 3- 22-2019 and 9-20-2019 were not performed by TS-B. TP-G's semi-annual CA dated 6- 8-2018 and 11-8-2018 were not performed by TS-B. TP-H's semi-annual CA dated 11- 1-2019 and 5-1-2020 were not performed by TS-B. During interview on the afternoon of May 20, 2021, General Supervisor 1 (GS-1) confirmed TS-B did not perform the semi-annual CA for TP-E, TP-F, TP-G and TP-H. -- 2 of 2 --