Sandhills Pediatrics At Dutch Fork

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on November 12, 2024, at the clinical laboratory of Sandhills Pediatrics at Dutch Fork by the South Carolina Department of Public Health's Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a list of standard level deficiencies cited: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) documentation, Wisconsin State Laboratory Hygiene (WSLH) PT documentation, laboratory documentation and staff interview, the laboratory failed to have laboratory director sign off on the attestation statement forms (4 out of 18) from 2022, 2023, and 2024. Findings Included: 1. The following events lack signature of the laboratory director: a. WSLH PT Hematology/Coagulation first event 2022 b. API PT Chemistry Core first event 2023 c. API PT Hematology/Coagulation third event 2023 d. API PT Chemistry Core third event 2024 2 Proficiency testing is performed for Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- and Chemistry three times annually accounting for eighteen total surveys in the time frame reviewed by the surveyor. 3. In an Interview on November 12, 2024, in the laboratory office with the office manager, the findings were confirmed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on laboratory environmental monitoring documentation and staff interview, the laboratory failed to document any

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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 proficiency testing desk review of Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and Wisconsin State Laboratory of Hygiene (WSLH) 2022 and 2023 records, the laboratory had not successfully participated in a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Cell Identification or White Blood Cell Differential analyte. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 proficiency testing desk review of CASPER form 0155 and (WSLH) 2022 and 2023 records, revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events in the specialty of Hematology for the Cell Identification or WBC Diff analyte. Findings Include: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for the Cell Identification or WBC Diff. Hematology 2023 - 1st Event the laboratory received an unsatisfactory score of 0% for the Cell Identification or WBC Diff. 2. A review of WSLH 2022 and 2023 proficiency testing records confirmed the laboratory received the above results D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and WSLH 2022 AND 2023 records, revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and WSLH 2022 AND 2023 records, revealed that the laboratory director failed to ensure the overall -- 2 of 3 -- quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 3 of 3 --