South Florida Center For Gynecologic Oncology

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/15/2021-10/21/2021, found South Florida Center For Gynecologic Oncology clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed manufacture's instructions to do six-month calibration in 2021 for the Medonic-M Series instrument in 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 -- Hematology. Findings included: Review of Medonic-M Series calibration folder revealed no documentation of completing a six-month calibration in 2021 for Medonic-M Series instrument. Review of Medonic M-Series calibration maintenance revealed calibrations are a 6-month maintenance requirement for the Medonic-M Series. During an interview on 10/21/2021 at 11:06AM, the office manager confirmed the six-month calibration was not performed in 2021 on Medonic-M Series. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 22, 2019. South Florida Center for Gynecologic Oncology clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to have all testing personnel rotate through the testing of proficiency testing samples for 2017 (3rd event), 2018 (1st, 2nd and 3rd event), and 2019 (1st and 2nd event). Findings: Review of the American Proficiency Institute (API) proficiency testing attestation forms showed that Testing Personnel B performed all the Proficiency Testing (PT) for 2018 (1st, 2nd and 3rd event), and 2019 (1st and 2nd event). Review of the CMS-209 form title "Laboratory Personnel Report (CLIA)" that was signed and dated by the Laboratory Director on 10/9/19 listed 2 testing personnel. During an interview on 10 /22/19 at 11:33 AM, the Manager A acknowledged that Testing Personnel B performed all the proficiency testing for the laboratory in 2018 and 2019, and that Testing Personnel B had performed the PT for the 3rd event in 2017 and failed to sign the attestation. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 7 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to receive a passing proficiency test (PT) score for the second testing event of 2019 for the specialty of Hematology. Findings: Review of the PT Performance Summary from American Proficiency Institute (API) for the second event of 2019 showed unsatisfactory scores for the CMS (Center for Medicare & Medicaid Services) reportable analytes of Erythrocyte count 60%, Hematocrit 60%, Hemoglobin 60%, Leukocyte Count 60%, Platelet Count 60%, and White Blood Cell Differential 60%. The overall score for the specialty of hematology was 60% (Erythrocyte count 60% + Hematocrit 60% + Hemoglobin 60% + Leukocyte Count 60% + Platelet Count 60% + White Blood Cell Differential 60% = 360% divided by 6 analytes = 60%). During an interview on 10/22 /19 at 11:25 AM, the Manager confirmed the laboratory had an unsuccessful scores in proficiency testing for the second event in 2019. 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 record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the general laboratory system and correct problems identified. Findings: Cross Reference D5209. Based on record review and staff interview, the laboratory failed to document competency assessment on 1 (B) of 2 Testing Personnel for 2018. Cross Reference D5221. Based on record review and interview, the laboratory failed to document proficiency testing (PT) evaluation and verification activities. 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 document competency assessment on 1 (B) of 2 (A, B)Testing Personnel for 2018. Findings: Review of the annual competency records showed that the laboratory failed to have documentation of competency assessment on Testing Personnel B for 2018. During an interview on 10/22/19 at 11:52 AM, the Manager stated she was unable to locate the competency assessment on Testing Personnel B for 2018.. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 7 -- CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document proficiency testing (PT) evaluation and verification activities. Findings: 1. Review of the API, "Proficiency Testing Performance Evaluation" form showed that the laboratory director failed to document