Personal Care Pediatrics

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/21/2023 found the PERSONAL CARE PEDIATRICS clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 D0000 A recertification survey conducted on 08/31/2021 found that the PERSONAL CARE PEDIATRICS clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and laboratory director (LD) interview, the laboratory failed to obtain a passing score of 80 % for Bacteriology in 1 out of 6 events reviewed (2019 to 2021). Findings include: Review of API PT records revealed a score of 40 % for Bacteriology in the 1st event of 2021. During an interview on 08/31/2021 at 11:30 AM, the LD confirmed that the laboratory failed the event of reference. 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 --