Kaplan Barron Pediatrics

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 01/18/2024. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to keep record of quality assurance (QA) documentation for 2023 for two (2) of two (2) consecutive quarters. Findings included: Record review on 01/18/2024 at 3:05 p.m. revealed that QA was not completed for quarter months of September 2023 and December 2023. During an interview on 01/18/2024 at 3:05 p.m., Testing Personnel (TP) #1 confirmed that QA was not documented for September 2023 and December 2023. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor accuracy of patient test reference ranges within the procedure when compared to reference ranges in patient rest reports for year 2022 and 2023 for four (4) of four (4) patient test 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 -- reports. Findings included: Record review on 01/18/2024 at 3:30 p.m. revealed reference ranges in a patient test report did not match reference ranges in the laboratory's procedure for Lymphocyte (LYM) %. a.) Patient test report had ranges for LYM% for an individual twelve (12) to eighteen (18 years) as 24% to 54% b.) Laboratory ranges for LYM% for an individual twelve (12) to eighteen (18 years) as 24%-50% During an interview on 01/18/2024 at 3:30 p.m., Testing Personnel (TP) #1 and the Laboratory Director (LD) confirmed that reference ranges on the patient test reports did not match reference ranges in the laboratory's procedure for Lymphocyte (LYM) analyte. -- 2 of 2 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on staff interview and record review on 08/24/2021, the laboratory director failed to write a

Summary Statement of Deficiencies 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)