Premier Medical Center, Inc

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 06/08/2023 and concluded on 06/08/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 policy review, interview, and document review, it was determined the Laboratory Director (LD) failed to ensure the competency of the Technical Consultant (TC) was assessed. Findings included: A review of the policy titled, "Personnel Competency Assessment," reviewed 01/19/2023, revealed, "Summary and Explanation /Intended Use: Laboratory staff who conduct the pre-analytical, analytical, and post- analytical phases of testing will be monitored to assure that they are competent and maintain their competency to process specimen, perform test procedures and report test results promptly and proficiently." The policy further indicated, "Other staff members are also required to prove their competency in relationship to the specific duties they are required to perform." A review of the "Laboratory Personnel Report (CLIA) [Clinical Laboratory Improvement Amendments]," signed by the LD and dated 06/08/2023, indicated the laboratory had one TC who function in chemistry. A review of the TC's personnel folder, revealed there were no competency evaluations. During an interview with the LD and TC on 06/08/2023 at 3:45 PM, both stated the TC had not had any competency evaluations. 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 D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: During an onsite initial survey on 01/30/2018, based on the laboratory procedure manual, lack of documentation, and testing personnel interview, the laboratory failed to document all test result comparison activities for 8 of 12 months reviewed (May 2017 through December 2017). Findings include: 1. The laboratory procedure manual stated that 5 charts would be reviewed quarterly to confirm the correct relationship of patient information to patient test results. 2. There were no chart reviews available for review on the day of the survey for the months May 2017 through December 2017. 3. Testing personnel confirmed during an onsite interview on 01/30/2018 at 1:30pm that the laboratory had failed to document quarterly chart reviews as required. 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 --