Accupath Diagnostic Laboratories Inc

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 record review, and an interview with the General Supervisor (GS), the laboratory failed to establish and follow a written policy and procedure to assess competency of the General Supervisor (GS) at the specific CLIA site, and as specified in the personnel requirements in subpart M. This deficient practice had the potential to affect 739 patients tested from 11/05/2021 through 06/22/2022. Findings Include: 1. Review of the laboratory's CMS-209 Personnel Report form, approved and signed by the Lab Director on 04/21/2022, found one individual listed as the GS. 2. Review of the laboratory's Competency Assessment policy and procedure titled, "Training and Competency Assessment Policy, SOP Number IO-GL-GN-SOP-0041.010", revealed the following statement: "Note: Site specific training must occur at the specific CLIA site" 3. Review of the laboratory's Competency Assessment documentation found a trainer's signature not listed on the CMS-209 Personnel Report form. 4. On 06/22 /2022 at 10:25 AM, the GS stated competency assessment training had been conducted at a different location by the trainer listed on the competency assessment documents and confirmed the lab did not follow their policy and procedure for assessing the competency at the CLIA specific site. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: ITEM 1: Based on document review and interviews with the Quality Manager (QM) and General Supervisor (GS), the laboratory failed to follow the procedure manual for training and competency assessments. This deficient practice had the potential to affect all patients tested under the subspecialty of general immunology from March 2019 to January 2020. Findings include: 1. Review of the laboratory's policy titled "Training and Competency Assessment Policy", approved by the Laboratory Director on 07/25/2018 found the following statement: "A. Training 1. An employee who is new to a job function must receive training on all tasks performed, as well as applicable instruments/methods, before being allowed to test independently. This includes employees new to the laboratory, employees who have transferred or have been promoted to different job duties." 2. Review of initial competency assessment documents for the GS revealed competency for the Sysmex hematology instrument was signed off on 03/27/2019, flow bone marrow was signed off on 03/21/2019 and flow instrument room was signed off on 03/25/2019 by personnel not list on the form CMS 209. 3. An interview with the QM and the GS on 01/30/2020 at 10:50 AM confirmed the initial competency assessments (in line 2 above) occurred at a different location. ITEM 2: Based on document review and interviews with the Quality Manager (QM) and General Supervisor (GS), the laboratory failed to follow the procedure manual for training and competency assessments. This deficient practice had the potential to affect all patients tested under the subspecialty of general immunology from March 2019 to January 2020. Findings include: 1. Review of the 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 -- laboratory policy titled "Training and Competency Assessment Policy", approved by the Laboratory Director 07/25/2018 found the following statement: "C. Competency Assessment Schedule Competency is assessed at the following times o After training /re-training o Semi-annually during the first year. o Annually after the first year o After an extended absence from assigned job duties." 2. Review of the 2019 annual "Technical Competency Evaluation Form" for Testing Personnel #1 (TP#1) revealed a 2019 assessment date of 01/29/2020. 3. An interview with the QM and the GS on 01 /30/2020 at 10:50 AM confirmed the 2019 annual competency assessment for TP#1 did not occur annually after the first year. ITEM 3: Based on document review and interviews with the Quality Manager (QM) and General Supervisor (GS), the laboratory failed to follow the procedure manual for training and competency assessments. This deficient practice had the potential to affect all patients tested under the subspecialty of general immunology from March 2019 to January 2020. Findings include: 1. Review of the laboratory policy titled "Training and Competency Assessment Policy", approved by the Laboratory Director 07/25/2018 found three out of eight elements listed as direct observations. 2. Review of the 2019 six month "Technical Competency Evaluation Form for BM/PB Sample Processing" for the GS revealed three direct observation elements. 3. Further review of the 2019 six month "Technical Competency Evaluation Form for BM/PB Sample Processing" for the GS revealed all seven elements initialed as completed by a designee not listed on the form CMS 209. 3. An interview with the QM and the GS on 01/30/2020 at 10:50 AM confirmed the six-month technical competency for the GS was not completed with the designee on site to observe and sign off. The designee via a phone interview on 01/30 /2020 at 10:52 AM also confirmed they had initialed and signed off on the form from a different location and was not present during the assessment. -- 2 of 2 --

Summary Statement of Deficiencies D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and an interview with the General Supervisor (GS), the Technical Supervisor (TS) failed to evaluate and document the 2017 competency of the GS who was responsible for high complexity Immunology testing. Findings Include: 1. Review of the laboratory's annual 2017 competency records found Testing Personnel completing competency assessing for the GS. 2. The GS confirmed the Testing Personnel had performed the annual competency assessment for the GS. The interview occurred on 03/13/2018 at 1:12 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 --