Florida Medical Laboratory Group Inc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 14, 2022 for Flrodia MedicaL Laboratory Group. Florida Medical Laboratory Group is not in compliance with the Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2021 and 2022, the laboratory had subsequent unsuccessful performance in proficiency testing for the analyte, free thyroxine (free T4) Refer to D2108. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of 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 3 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 14, 2022 at 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, free T4 for three out three consecutive testing events in 2021 and 2022. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory had subsequent unsuccessful participation in proficiency testing for the analyte, free T4. Findings include: On September 14, 2022 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory had unsuccessful proficiency testing scores for three consecutive testing events for the analyte, free T4, as shown below. Event #3, 2021 free T4-20% Event #1, 2022 free T4-60% Event #2, 2022 free T4-0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of endocrinology. Findings include: On September 14, 2022, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had subsequent unsatisfactory proficiency testing score for the analyte, free T4, in the specialty of endocrinology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of endocrinology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on September 14, 2022, on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores for three consecutive testing events as shown below. Event #3, 2021 free T4-20% Event #1, 2022 free T4-60% Event #2, 2022 free T4-60% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on April 6, 2022 for Florida Medical Laboratory Group. Florida Medical Laboratory Group is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2021 and 2022, the laboratory did not have successful performance in proficiency testing in the subspecialty of endocrinology. Refer to D2107. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of 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 3 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on April 6, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, free thyroxine for two out of three testing events in 2021 and 2022. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of endocrinology. Findings include: On April 6, 2022 on or about 10:00 AM the American Profieincy Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, free thyroxine, as shown below. Event #3, 2021 free thyroxine-20% Event #1, 2022 free thyroxine-60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of endocrinology. Findings include: On April 6,2022 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, free thyroxine, in the subspecialty of endocrinology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2107. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of endocrinology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on April 6, 2022 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #3, 2021 free thyroxine-20% Event #1, 2022 free thyroxine-60% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Florida Medical Laboratory Group Inc. on 9/01/2021. The laboratory is not in compliance with the 42 CFR Part 493, Requirements for 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 staff interview, the facility failed to have a passing proficiency test score for the analytes "Sodium" and "Chloride" during the 1st Chemistry testing event in 2021. The findings include: The record review on 9/1/21 of the American Proficiency Institute 1st Chemistry event of 2021 showed a score of 0% for the analyte "Sodium" and a score of 0% for the analyte "Chloride". The 9/1/21 interview with the Technical Supervisor at 12:15pm confirmed the failure in proficiency testing. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to retain laboratory temperature records and instrument maintenance logs for December 2020. 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 5 -- findings include: 1. The laboratory was unable to provide documentation that showed laboratory instrumentation maintenance was performed according to manufacturer instructions for the month of December 2020. The instruments in use: Beckman Coulter AU480, Clinitek Advantus, Sysmex XN-500, and Beckman Coulter Access 2. 2. The laboratory was unable to provide documentation that showed the temperature of the laboratory, the refrigerator, or the freezer was being monitored in December 2020. During the interview with the Technical Supervisor on 9/1/21 at 10:53am, it was confirmed the temperature and maintenance records were missing. 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 interview with the Laboratory Director, the laboratory had not performed competency assessment on the Technical Supervisor/Technical Consultant since the laboratory opened in 2020. The findings include: Record review of competency records revealed that competency evaluations had not been performed for the Technical Supervisor/Technical Consultant. During the interview on 9/1/21 at 11:05am, the Technical Supervisor/Technical Consultant acknowledged they had not received a competency evaluation from the Laboratory Director. 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 record review and staff interview, the laboratory failed to ensure the accuracy of Thyroglobulin Antibodies and Thyroid Peroxidase Antibodies testing at least twice a year for 2020 - 2021 for the subspecialty of Immunology. The findings include: Review of proficiency testing documentation for 2020 and 2021 showed that Thyroglobulin Antibodies and Thyroid Peroxidase Antibodies were not included in the proficiency testing records. During the interview on 9/1/21 at 12:05 PM, the Technical Supervisor confirmed that the laboratory did not enroll the analytes for proficiency testing or verify twice annually to confirm accuracy. D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to retain documentation that showed how the accuracy, precision, and reportable range was determined for the -- 2 of 5 -- Clinitek Advantus urinalysis instrument. The findings include: The laboratory was unable to provide raw documentation that showed how the Clinitek Advantus was validated prior to patient testing. During and interview on 9/1/21 at 9:20am, the Technical Supervisor confirmed the documentation was missing. D5783