G Alexander Carden Md Pa & David W Dodson Md Pa

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 06/06/2023 to 06/28/2023 at G Alexander Carden MD PA and David W Dodson MD PA. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at 1:00 PM on 06/14/2023. The following Condition was not met: D5200 - General Laboratory System 493.1230 D5400 - Analytic System 493.1250 D6000 - Moderate Complexity Laboratory Director 493.1403 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 Personnel Report, proficiency testing (PT) records and interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) in the specialty of Hematology for six of six (2021 2nd, 3rd, 2022 1st, 2nd, 3rd and 2023 1st) events. Findings Included: Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 06 /03/2023, listed two testing personnel (Testing Person A [TP-A] and Testing Person B [TP-B]). Review of the PT records from American Proficiency Institute (API) showed all the PT attestation forms were signed by Testing Person A (TP-A) as the "Person Performing Test" for the hematology PT for 2021 2nd, and 3rd event, 2022 1st, 2nd, 3rd event, and 2023 1st event. On 06/06/2023 at 11:49 AM, TP-A confirmed that TP- B performed patient testing on the hematology analyzer and did not participate in any PT testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of competency evaluation records, the procedure manual, the laboratory's

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at G Alexander Carden MD PA & David W Dodson MD PA on 6/3/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform competency assessments on two (#A and #C ) out of two Testing Personnel (#A and #C) for the years 2019 and 2020. The findings included: A review of the CMS 209 Laboratory Personnel Report revealed Staff #A and #C worked at the laboratory as Testing Personnel (TP). A review of personnel records from 2019 - 2020 revealed no competency evaluations were found for TP #A and TP #C. A review of the facility procedure manual section "Performance/Competency Testing" revealed, "The purpose of the testing is to assess the qualifications and performance of the laboratory testing staff on an annual basis." In an interview, on 6/3/21 at 10:30 a.m., Testing Personnel #A stated she did not know the laboratory was to complete competency evaluations for herself or TP #C and added the consultant had retired. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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: Based on record review and staff interview, the laboratory failed to perform verification of quality controls for two out of two years (2019-2020). The findings included: Verification of quality controls documentation was not available at the time of survey. Review of the facility procedure manual section "Quality Control" revealed "For new controls or new control lots, the mean of each assay/instrument combination is established by running the new control for a minimum of two weeks ( one week with 5 replicates of hematology controls)." In an interview, on 6/3/21 at 11:15 a.m., Testing Personnel #A stated she did not know that she was to perform verification of quality control verifications. D5781

Summary Statement of Deficiencies D0000 An announced initial certification survey was conducted on 12/4/19 at G. Alexander Carden MD PA and David Dodson MD PA, a clinical laboratory in West Palm Beach, Florida. G. Alexander Carden MD PA and David Dodson MD PA is not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review and interview with laboratory personnel, the laboratory failed to attain a satisfactory score for one analyte on the second testing event of 2019. The findings included: Review of that past two years of proficiency testing records on 12/4 /19 revealed that the laboratory received a score of 60% for albumin on the second testing event of 2019. During an interview at 12:10 p.m. on 12/4/19, the laboratory consultant confirmed that they had received an unsatisfactory score, and that they had taken