Sofha Pediatrics Of Kingsport

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and staff interview, the laboratory director/designee failed to sign one of four PT attestation statements reviewed from 2025 and 2026. The findings include: 1. A review of the laboratory's American Proficiency Testing (API) PT records revealed that the laboratory director/designee failed to sign the attestation statement for 2026 Event One. 2. An interview on 06.08.2026 at 11:40 a.m. with the technical consultants (TC1 and TC2) confirmed the above survey findings. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers for Medicare & Medicaid Services Laboratory Personnel Report (FORM CMS-209), personnel records, and staff 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 -- interviews, the laboratory director failed to define the duties and responsibilities of one of two technical consultants. The findings include: 1. A review of the FORM CMS-209 revealed two technical consultants (TC1 and TC2) listed. 2. A review of the laboratory's personnel records revealed no job description or list of duties and responsibilities defined for TC2. 3. An interview on 06.08.2026 at 11:40 a.m. with TC1 and TC2 confirmed the above survey findings. -- 2 of 2 --

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 a review of the Centers for Medicare and Medicaid Services CASPER Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events in 2024, resulting in initial unsuccessful participation for the automated white blood cell differential (WBC DIFF) analyte. (See 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: Based on a desk review of the CMS 155 and the laboratory's American Proficiency Institute (API) PT evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive test events for the automated white blood cell differential (WBC DIFF) analyte, resulting in initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory WBC DIFF scores: - 2024 Event one: 0% - 2024 Event two: 52% 2. A review of the laboratory's API PT evaluation report revealed the following unsatisfactory WBC DIFF scores: - 2024 Event one: 0% - 2024 Event two: 52% -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: ==================================== Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, the Centers for Medicare and Medicaid Services Form 209 Laboratory Personnel Report (CMS-209) and interview with the laboratory technical consultant, determined that PT samples were not tested by all testing personnel listed on the CMS-209 in 2020, 2021, and 2022. The findings include: 1. Review of the laboratory's API Proficiency Testing Attestation records revealed only one of three testing personnel's signature as testing PT samples (2020 Event 2 and 3; 2021 Event 1, 2 and 3; 2022 Event 1 and 2). 2. Review of the CMS-209 revealed three personnel who perform patient testing. 3. Interview with the technical consultant on September 9, 2022 at 11:30 am confirmed that PT samples were not tested by all testing personnel listed on the CMS-209 for 7 events in 2020, 2021, and 2022. ==================================== 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 --