Wayne Memorial Hamlin Laboratory

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, interview with the laboratory manager and technical consultant (TC) #2, the laboratory failed to establish a complete competency assessment policy to assess the competency of 1 of 2 TCs and 4 of 4 testing personnel (TP) in 2018 to the day of survey. Findings Include: 1. On the day of survey, 02/26/2020, the laboratory failed to provide a complete competency assessment policy to assess the competency of 1 of 2 TC and 4 of 4 TP from 01/10 /2018 to 02/26/2020. 2. The laboratory manager and TC #2 confirmed the finding above on 02/26/2020 around 10:00 am. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records, review of the American Proficiency Institute (API) 2018 and 2019 proficiency testing (PT) attestation sheets, interview with the laboratory manger and technical consultant (TC) #2, the TC failed to assess the competency of 2 of 4 TP through external hematology PT or internal 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 -- blind testing samples in 2018 and 2019. Findings Include: 1. On the day of survey, 02 /26/2020, review of TP records and API PT attestation sheets revealed, the laboratory did not assess the test performance of 2 of 4 TP (on the CMS 209 Testing Personnel Form - TP #1 and #4) thorough hematology PT samples or internal blind testing samples in 2018 and 2019. 2. The laboratory manager and TC #2 confirmed the finding above on 02/26/2020 around 10:30 am. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of hCG quality control (QC) records and interview with the Technical Consultant and Laboratory Manager, the laboratory failed to perform a negative and positive control material each day of patient testing for Serum hCG from 2016 to the time of survey. Findings include: 1. At the time of survey (1/10/2018 start time of 1:00 PM)), it was discovered that the laboratory did not perform QC at least each day of patient testing for Serum hCG testing preformed on Fischer Scientific Sure-Vue hCG Stat Urine/ Serum Kit. 2. In 2016, 20 Serum hCG tests were performed. 3. The Technical Consultant and Laboratory manager confirmed the findings above on 1/10/2018 around 2:30 PM. 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 --