Paul G Smith Jr Do Pllc

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 Casper Report 155 (CMS 155) and the laboratory's 2024 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for the White Blood Cell Differential (WBC-DIFF), Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), and Platelet Count (PLT) analytes (Refer to D2130) and the Hematology specialty (Refer to D2131) resulting in initial unsuccessful PT performance. 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 -- 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 the CMS 155 and the laboratory's WSLH PT evaluation reports, the laboratory failed to maintain satisfactory performance for two of three test events for the White Blood Cell Differential (WBC-Diff), Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), and Platelet Count (PLT) analytes. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory scores: -2024 Event 1: 0% for WBC-DIFF, RBC, HCT, HGB, WBC, PLT -2024 Event 3: 0% for WBC-DIFF, RBC, HCT, HGB, WBC, PLT 2. Review of the laboratory's 2024 WSLH Hematology Comprehensive evaluation reports revealed the following unsatisfactory scores: -2024 Event 1: 0% for WBC- DIFF, RBC, HCT, HGB, WBC, PLT -2024 Event 3: 0% for WBC-DIFF, RBC, HCT, HGB, WBC, PLT D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing 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 WSLH PT evaluation reports, the laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in two of three PT events in 2024. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory Hematology PT event scores: -2024 Event 1: 0% -2024 Event 3: 0% 2. Review of the laboratory's 2024 WSLH Hematology Comprehensive evaluation reports revealed the following unsatisfactory Hematology event scores: -2024 Event 1: 0% -2024 Event 3: 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: =================================== Based on review of Proficiency Testing (PT) scores from 2018 and 2019 and interview with lead laboratory testing personnel, the laboratory failed to prove twice a year accuracy verification for microscopic urine sediment. The findings include: 1. A review of PT scores for 2018 and 2019 showed unacceptable scores of 50% for one of two events in 2018 and 2019. 2. An interview with the lead laboratory testing personnel at approximately 12:45 on October 31, 2019 confirmed the laboratory failed to prove twice a year accuracy verification through PT for urine sediment during 2018 and 2019. =================================== 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 --