Advocare Broomall Pediatric 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's competency assessment records and interview with the Nurse Manager (NM), the laboratory failed to establish a procedure to assess the competency of 10 of 11 technical consultants (TC) for their supervisory responsibilities in 2022. Findings include: 1. On the day of survey, 08/30/2023 at 11: 07 AM, the laboratory could not provide competency assessment records for the following personnel for their supervisory responsibilities in 2022: - 10 of 11 TC (CMS 209, personnel #2, #3, #4, #5, #6, #7, #8, #9, #10, #11) 2. The NM confirmed the findings above on 08/30/2023 at 12:59 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 --

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 1 of 9 testing personnel (TP) who performed throat cultures for streptococcus group A from 08/12/2019 to the day of survey. Findings Include: 1. On the day of survey 08/12/2021 at 10:00 a.m., the laboratory could not provide competency assessment records for 1 of 9 TP (CMS 209 personnel #6) who analyzed streptococcus group A throat cultures from 08/12/2019 to the day of survey. 3. The NM confirmed the finding above on 08/12/2021 at 11:00 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) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 testing personnel (TP) #1, the laboratory failed to follow TC incubation procedures in 2018. Findings include: 1. The laboratory TC PM (also the Presumptive Identification of Group A Beta-Hemolytic Streptococci by Culture, Bureau of Laboratory, Department of Health), the laboratory directory signed off on 10/03/2018, states "If negative for growth beta-hemolytic streptococci, re-incubate for an additional 24 hours." 2. The laboratory TC log shows the laboratory streaked 5 plates (11/30/2018-12/01/2018), from which a summary reads as follows: Plate Read Result (Hours) Streak Date Number 24 24-48 11/30/2018 3 Negative No Data 12/01 /2018 1 Positive ----------- 12/01/2018 1 Negative No Data 3. Of the 4 TC tested negative at 24 hours, none (4 of 4) re-incubated and re-tested at 24-48 hours. 4. The laboratory reported all these TC results electronically. 5. The TP #1 confirmed above findings on 12/03/2018 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 --