Advocare Main Line Pediatrics

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 Laboratory competency policy and interview with the Practice Manager, the laboratory failed to establish a complete procedure to assess the competency of the 6 of 7 Clinical Consultants for their supervisory responsibilities in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 10/27/2020 at 09:41 a.m., the Practice Manager could not provide a complete policy that reviews how to assess the competency for 6 of 7 Clinical Consultants for their supervisory responsibilities during 2018, 2019 and 2020. 2. The Laboratory Director acted Clinical Consultant as well as a Technical Consultant. 3. The Practice Manager confirmed the finding above on 10/27/2020 around 11:00 am. 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: Based on review of laboratory procedure manual (PM), throat culture (TC) log, and interview with the nurse manager, the laboratory failed to follow TC agar plate incubation procedures in May 2018. Findings include: 1. The laboratory TC PM (also the Collection, Culture, and Interpretation of a Throat Culture Screen for Presumptive Identification of Group A Streptococci, CDC) states "Re-incubate negative agar plates for an additional 24 hours and document final results." 2. The laboratory TC log (05/07 /2018-05/11/2018) showed the laboratory streaked 22 specimens, from which a summary reads as follows: Read Result (hours) Streak Date Specimen 24 48 05/07 /2018 4 Negative No Data 05/08/2018 6 Negative No Data 05/09/2018 5 Negative No Data 05/10/2018 4 Negative No Data 05/11/2018 3 Negative No Data 3. Total 22 TCs tested negative at 24 hours, but none (22 of 22) re-incubated and re-tested at 48 hours. 4. The laboratory reported all these 22 TC test results electronically. 5. The nurse manager confirmed above findings on 05/22/2018 at 10:00 AM. 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 --