Sandhills Pediatric & Adolescent Clinic

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 desk review of proficiency testing scores from the Casper Report 0155D and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing summary, the laboratory failed to successfully participate in a proficiency testing program approved by CMS. Findings included: 1. Review of Casper Report 0155D reveals failure to successfully participate in a CMS approved proficiency testing (PT) program by scores of 0% for 2 out of 3 events for 2023 as follows for White Blood Cell (WBC) Count: a. WSLH 2023 HemeReg1 score 0% b. WSLH 2023 HemeReg3 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 -- score 0% 2. Review of CLIA regulations reveals that successful participation in a CMS approved PT program is testing scores of a minimum of 80% for each analyte tested. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores from the Casper Report 0155D and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing summary, the laboratory unsuccessfully participated in a proficiency testing program subspecialty Hematology approved by CMS. Findings included: 1. Review of Casper Report 0155D reveals failure to successfully participate in a CMS approved proficiency testing (PT) program by scores of 0% for 2 of 3 events in 2023 as follows for White Blood Cell (WBC) Count: a. WSLH 2023 HemeReg1 score 0% b. WSLH 2023 HemeReg3 score 0% 2. Review of CLIA regulations reveals that successful participation in a CMS approved PT program is testing scores of a minimum of 80% for each analyte tested. 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 desk review of proficiency testing scores from the Casper Report 0155D and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing summary, the laboratory failed to successfully participate in a proficiency testing program subspecialty Hematology approved by CMS. Findings included: 1. Review of Casper Report 0155D reveals failure to successfully participate in a CMS approved proficiency testing (PT) program by scores of 0% for events 2 out of 3 events for 2023 for the following White Blood Cell (WBC) Count: a. WSLH 2023 HemeReg1 score 0% b. WSLH 2023 HemeReg3 score 0% 2. Review of CLIA regulations reveals that successful participation in a CMS approved PT program is testing scores of a minimum of 80% for each analyte tested. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted at the clinical laboratory of Sandhills Pediatrics Columbia on July 22, 2024, by the South Carolina Department of Public Health's (SC DPH) 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 description of the CONDITION and STANDARD level 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 graded reports from Wisconsin State Laboratory of Hygiene (WSLH), Proficiency Testing Documentation Checklists, and staff interview, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory failed to successfully participate in a proficiency testing program approved by CMS for Specialty of Hematology, the analyte white blood cell differential (WBC diff). Findings included: 1. Review of the WSLH proficiency testing results from the 2022 (HemeReg1) Hematology 1st event reveals a score as follows: a. WBC auto differential 0% b. Lymphocytes 0% c. Monocyte/Mid-Range Cells 0% d. Granulocytes 0% 2. Review of the WSLH performance summary reveals lack of participation in the WSLH 2023 (HemeReg3) Hematology 3rd event. 0% scores for all analytes for that event. 3. Results of WSLH 2023 (HemeReg3) Hematology 3rd event were confirmed with WSLH via email on 07/24/2024 at 12:25pm. Testing results for subspecialty of Hematology are as follows: a. Leukocytes analyte score 0% b. Erythrocytes analyte score 0% c. Hemoglobin analyte score 0% d. Hematocrit analyte score 0% e. MCV analyte score 0% f. Platelets analyte score 0% Testing results for the subspecialty WBC auto differential are as follows: a. Lymphocyte % score 0% b. Monocyte/Mid-Range Cells % score 0% c. Granulocytes % score 0% 4. Review of the laboratory's "Proficiency Testing Documentation Checklist" reveals lack of online result submission for WSLH 2023 (HemeReg3) Hematology 3rd event. 5. In an interview on July 22, 2024, at 5:00pm in the laboratory office with the office manager (OM), the findings were confirmed. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on WSLH Proficiency testing review, laboratory documentation, and staff interview, the laboratory failed to attain a score of at least 80% of acceptable responses for each analyte for each event in 3 of 3 years (2022, 2023, and 2024). Findings included: 1. Review of the WSLH performance summary reveals lack of participation in the WSLH 2023 (HemeReg3) Hematology 3rd event. 0% scores for all analytes for that event. 2. Review of the laboratory's "Proficiency Testing Documentation Checklist" reveals lack of online result submission for WSLH 2023 (HemeReg3) Hematology 3rd event. 3. Results of WSLH 2023 (HemeReg3) Hematology 3rd event were confirmed by WSLH on 07/24/2024 at 12:25pm. The results for Subspecialty Hematology were as follows: a. Leukocytes analyte score 0% b. Erythrocytes analyte score 0% c. Hemoglobin analyte score 0% d. Hematocrit analyte score 0% e. MCV analyte score 0% f. Platelets analyte score 0% Testing results for the subspecialty WBC auto differential are as follows: a. Lymphocyte % score 0% b. Monocyte/Mid-Range Cells % score 0% c. Granulocytes % score 0% 4. In an interview on July 22, 2024, at 5:00pm in the laboratory office with the OM, the findings were confirmed. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory document review and staff interview, the laboratory failed to document maintenance and function checks. Findings included: 1. Review of the laboratory's daily, weekly, and monthly checklist revealed no documentation of monthly activities listed for 30 of 30 months reviewed for 2022,2023, and 2024. 2. The activities documented on the monthly checklist included: a. Emergency Lights and Fire Extinguisher check b. Check expiration dates of lab supplies c. Check expiration dates of med supplies d. Check 1 Hgb against CBC e. Check timing on Hct centrifuge f. OSHA Safety Meeting completed g. Compliants reviewed and addressed 3. In an interview on July 22, 2024, at 5:00pm in the laboratory office with the OM, the findings were confirmed. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require