Principle Labs, Llc

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 a lack of documentation and interview with the Quality Assurance (QA) supervisor, the laboratory failed to follow an established competency assessment procedure to assess the competency of 1 of 2 Technical Supervisor (TS) and 1 of 1 General Supervisor (GS) for their supervisory responsibilities performed from 2021 through 2023. Findings include: 1. The laboratory's Competency policy states, "Each employee has competency assessed and documented for each procedure the employee performs. For new employees, after initial training, competency will be done at 6 months, then 6 months later (1 year anniversary) and annually thereafter. Competency of consultants and supervisors is assessed against the CLIA defined responsibilities of the position(s) that they hold." 2. On the day of the survey, 06/17/2024 at 09:46 am, the laboratory could not provide competency assessment documents to assess the competency of the following individuals for their supervisory responsibilities performed from 2021 to 2023: - TS #1 (CMS 209 personnel #2) for 2022 and 2023 - GS #1 (CMS 209 personnel #3) for 2021, 2022 and 2023 3. The QA supervisor confirmed the findings above on 06/17/2024 at 1:55 pm. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the Quality Assurance (QA) supervisor, the laboratory failed to verify the accuracy of PT results obtained for 3 of 3 API Microbiology testing events in 2023. Findings Include: 1. The API Proficiency Testing performance Evaluation form states "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 This facility is in compliance with 42 CFR Part 493. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) records and interview with the Administrative Director (AD), the Laboratory Director (LD) and Testing Personnel (TP) failed to sign the API PT attestation statement documents from 2018, 2019, and 2020. Findings include: 1. On the day of survey, 09/04/2020, review of API PT records revealed, the following API PT attestation statement documents were not signed by the LD: - 2018, Event #3, Hematology/coagulation. - 2018, Event #3, Chemistry Core. - 2020, Event #2, Covid 19. - 2020, Event #2, Chemistry Core. 2. The following API PT attestation statement documents were not signed TP performing: - 2018, Event #3, Chemistry Core. - 2019, Event #2, Immunology/immunohematology. 3. The AD confirmed the findings above on 09/04 /2020 at 10:30 am. 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. 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 review of Laboratory competency policy and interview with the Administrative Director (AD), the laboratory failed to establish a complete procedure to assess the competency of the technical consultant and general supervisor (on the CMS 209 form, listed as personnel #2) for their regulatory responsibilities in 2019 and 2020. Findings include: 1. On the day of survey, 09/04/2020, the Administrative Director (AD), could not provide a complete policy that reviews how to assess the competency for 1 of 1 technical consultant and general supervisor or their regulatory responsibilities in 2019 and 2020. 2. The AD confirmed the finding above on 09/04 /2020 around 09:00 am. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved