Harpeth Pediatrics Pllc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 observation of the laboratory, a review of the laboratory's procedure manual, quality control (QC) records, lack of records, electronic patient data report, and staff interviews the laboratory failed to follow the procedure for QC used for the Cell-Dyn Emerald instrument used for patient complete blood count with automated differential (CBC w/Diff) testing for one of five dates reviewed in 2025. The findings include: 1. Observation of the laboratory on 10/14/2025 at 10:00 a.m. revealed the Cell-Dyn Emerald (Serial 030225-010950) instrument used for CBC w/Diff patient testing. 2. A review of the laboratory's procedure, "Quality Control Assessment," revealed that the laboratory was required to perform three levels (low, normal, and high) of the Cell- Dyn 18 Plus controls each day and that a minimum of two levels must be within the established range for the run to be acceptable. If the laboratory rejected the run due to QC values that were outside of the established range, the laboratory personnel were required to rerun QC and document all

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Review of the Centers for Medicare and Medicaid Service (CMS) CASPER report 155 and the American Proficiency Institute (API) Performance Summary report the laboratory failed to achieve successful performance for the1st and 2nd event 2019 in the Cell I.D. or White Blood Cell Diff (WBC) resulting in 1st unsuccessful performance in 2019. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: 1. Review of the CMS Casper 155 report revealed White Blood Cell Differential (WBC DIFF) 1st event 2019 with a score of 0% and 2nd event 2019 with a score of 33%. 2. Review of the American Proficiency Institute (API) performance summary report revealed WBC DIFF 1st event 2019 with a score of 0% and 2nd event 2019 with a score of 33%. Granulocytes 1st event 2019 with a score of 0% and 2nd event 2019 with a score of 0% and Lymphocytes 1st event 2019 with a score of 0% and 2nd event 2019 with a score of 20%. -- 2 of 2 --