Southern Medical Group

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Through a review of the laboratory Policy and Procedure Manual, observations made during a tour of the laboratory, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to follow written policies for positive identification of urine specimens. As evidenced by: A. A review of the laboratory policy section for specimen collection and handling revealed "Record patients name and one other unique identifier (e.g.- date of birth, account number, or accession number on tubes and other specimen containers)." B. During a tour of the laboratory, at 1400 on 5/26/2022, the surveyor observed five urine containers in the laboratory sink. Five of five urine containers were labeled with the patients first and last name only. C. In an interview at 1400 on 5/25/2022, the technical consultant confirmed the urine containers were not labeled according to laboratory policy. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when 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 -- they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of the laboratory's policy and procedure manual, Chemistry Quality Control (QC) records for January thru April of 2022, medical records, lack of documentation as well as interview with staff it was determined the laboratory failed to document Chemistry QC on days when patients were tested. Survey Findings Follow: A. A review of the Laboratory policy manual revealed the Chemistry Quality Control policy: "All quantitative quality control values will be plotted on Levy- Jennings (LJ) graph observed daily and printed monthly. Each control will have a target (mean) and a 2SD range. If control values are in range, patient samples can be tested, and test results reported. If either control is outside its 2SD range,

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through an interview with laboratory staff, a review of BioRad Lyphochek quality control assay sheets and instructions for use for the current lot of controls, a review of monthly "Quality Control Individual Reports", a review of package inserts for BioRad quality control, it was determined the laboratory failed to establish statistical parameters for acceptable quality control ranges of tests performed on the ECi analyzer. Survey findings follow: A. During an interview at 12:08 a.m. on 10/31 /2019, laboratory employee #3 (as listed on the form CMS-209) stated for evaluation of acceptability of quality control the laboratory is, "going by the package insert". B. BioRad Lyphochek quality control material instructions for use state, "It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides." C. A review of assay values, from package inserts, for five analytes tested on the Lyphocheck Controls revealed the following package insert ranges: Ferritin Level 1 28.2 to 56.1; Ferritin Level 2 79.6 to 136; Ferritin Level 3 216 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 -- to 354 Vitamin B12 Level 1 222 to 470; Vitamin B12 Level 2 476 to 751; Vitamin B12 Level 3 733 to >1000; Free T4 Level 1 1.21 to 2.15; Free T4 Level 2 4.86 to 5.80; PSA Level 1 .659 to .955; PSA Level 2 1.99 to 2.78; PSA Level 3 10.6 to 14.8; Testosterone Level 1 95.1 to 205; Testosterone Level 2 573 to 1029; and Testosterone Level 3 1156 to 2014. D. A review of acceptable ranges listed on the September 2019 "Quality Control Individual Reports", printed from the chemistry analyzer, shows the following ranges programmed into the analyzer which do not match the package insert assay values: Ferritin Level 1 32.2 to 52.2; Ferritin Level 2 95.34 to 120.66; Ferritin Level 3 252.14 to 317.86; Vitamin B12 Level 1 328.32 to 363.68; Vitamin B12 Level 2 529.08 to 622.92; Vitamin B12 Level 3 835.99 to 962.01; Free T4 Level 1 1.538 to 1.822; Free T4 Level 2 5.12 to 5.54; PSA Level 1 .745 to .869; PSA Level 2 2.208 to 2.632; PSA Level 3 11.694 to 13.706; Testosterone Level 1 137.8 to 162.2; Testosterone Level 2 754.68 to 857.32; and Testosterone Level 3 1498.1 to 1681.9. In further review of the September 2019 "Quality Control Individual Reports" there were several days with quality control results outside of the listed ranges without

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Through a review of the new instrument validations, which were performed on 04/11 /2016, for the Vitros ECI Immunoassay Analyzer, and Vitros 350 Chemistry Analyzer, a review of the Ortho-Diagnostic Measurement Data Reports, as well as interviews with staff, it was determined the laboratory failed to validate the reportable range established by the manufacturer for four of seven Immunoassays validated on the Vitros ECI and seven of twenty-one Chemistry assays validated on the Vitros 350. As evidenced by: A. A review of the validation documentation for the Vitros ECI Immunoassay revealed the following manufacturer's analytical ranges for the analytes listed: Vitamin B12 (159 to 1000); Ferritin (0.29 to 1000); Testosterone (4.903 to 2163) and Vitamin D (12.8 to 126). B. A review of the Ortho-Diagnostic Measurement Data Report for the Vitros ECI Immunoassay revealed the following ranges validated by testing standards: Vitamin B12 (159 to 898.00); Ferritin (0.29 to 949.5); Testosterone (4.903 to 1870) and Vitamin D (12.8 to 111). The laboratory did not validate the full analytic range established by the manufacturer. C. A review of the validation documentation for the Vitros 350 Chemistry analyzer revealed the following manufacturer's analytical ranges for the listed analytes: Chloride (CL) (50 to 175); Alanine Aminotransferase (ALT) (6 to 1000); Aspartate Aminotransferase (AST) (3 to 750); Triglycerides (TRIG) (10 to 525); Total Bilirubin (TBILI) (0.1 to 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 -- 27); Iron (Fe) (10.1 to 600) and Glucose (GLU) (20 to 625). D. A review of the Ortho- Diagnostic Measurement Data report for the Vitros 350 Chemistry revealed the following ranges validated by testing standards: CL (50 to 141); ALT (6 to 848); AST (3 to 722); Triglycerides (TRIG) (10 to 455); Total Bilirubin (TBILI) (0.1 to 18); Iron (Fe) (10.1 to 585) and GLU (20 to 608). The laboratory did not validate the full analytic range established by the manufacturer. E. In an interview at 13:20 on 05/16 /2018, technical consultant ( as listed on the form CMS-209) confirmed the laboratory did not validate the full reportable range claimed by the manufacturer for the Vitros 350 Chemistry and the Vitros ECI Immunoassay analyzers. -- 2 of 2 --