Advocare Broomall Pediatrics Associates

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 procedures, competency assessment records and interview with the Testing Personnel (TP) #6 (CMS 209 personnel #7), the laboratory failed to establish written policies and procedures to assess the competency of 3 of 4 technical consultant (TC) for their supervisory responsibilities and 2 of 6 testing personnel (TP) who performed throat cultures for streptococcus group A from 07/29 /2021 to 07/13/2023. 1. On the day of survey, 07/13/2023 at 10:02 am, the laboratory could not provide a written procedure to assess the competency for 3 of 4 TC (CMS 209 personnel # 8, 9 and 10) for their supervisory responsibilities in 2021, 2022 and 2023. 2. The laboratory could not provide the following competency assessment records for 2 of 6 TP who performed streptococcus group A throat cultures: - 1 of 6 TP (CMS 209 personnel #6) competency assessment records for 2021 and 2022. - 1 of 6 TP (CMS 209 personnel #7) competency assessment records for 2022. 3. The TP #6 confirmed the findings above on 07/13/2023 around 11:30 am. *Repeat deficiency. 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 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 competency assessment record review and interview with the Nurse Manager (NM), the Laboratory failed to follow the Laboratory's written policies and procedures to assess the competency of 2 of 10 testing personnel (TP) who performed Throat cultures for streptococcus group A from 07/29/2019 to 07/29/2021. Findings Include: 1. On the day of survey 07/29/2021 at 10:05 a.m., review of the competency assessment records revealed the following: - 1 of 10 TP (CMS 209 personnel #4) the laboratory did not evaluate twice yearly for the first year for streptococcus group A throat cultures. - 1 of 10 TP (CMS 209 personnel #8) the laboratory could not provide competency assessment records or streptococcus group A throat cultures from 2019, 2020, and 2021. 3. The NM confirmed the findings above on 07/29/2021 at 10:15 a.m. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)