E-Lab Of Florida

Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/14/2021 found that E-LAB OF FLORIDA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: -D3000. Facility Administration. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least 80 % in Bacteriology for the second proficiency testing (PT) event in 2020. Findings include: Review of Bacteriology American Association of Bioanalysts (AAB) PT records, revealed a 40 % score in the second event of 2020. During an interview on 12/14/2021 at 1:25 PM, the owner confirmed that the laboratory failed to receive a passing score of at least 80 % in Bacteriology in the second event of 2020. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on lack of records and owner interview, the laboratory failed to have documentation of the

Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/14/2021, found the E-Lab of Florida clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition was not met: D5400 - Analytic Systems. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least 80 % in Bacteriology for the second proficiency testing (PT) event in 2020. Findings include: Review of Bacteriology American Association of Bioanalysts (AAB) PT records, revealed a 40 % score in the second event of 2020. During an interview on 12/14/2021 at 1:25 PM, the owner confirmed that the laboratory failed to receive a passing score of at least 80 % in Bacteriology in the second event of 2020. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on lack of records and owner interview, the laboratory failed to have documentation of the

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on August 11, 2021 for E-Lab of Florida. E-Lab of Florida 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 2020 and 2021, the laboratory did not have successful performance in proficiency testing in the subspecialty routine chemistry. Refer to D2096. Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on 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 -- August 11, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, lactate dehydrogenase for two out of three testing events in 2020 and 2021. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 routine chemistry. Findings include: On August 11, 2021 on or about 10:00 AM the American Association of Bioanalysts (AAB) 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, lactate dehydrogenase, as shown below. Event #1, 2021 lactate dehydrogenase-0% Event #2, 2021 lactate dehydrogenase-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 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 routine chemistry. Findings include: On August 11, 2021 on or about 10:00 AM, the American Association of Bioanalysts (AAB) 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, lactate dehydrogenase, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. 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 -- 2 of 3 -- the subspecialty of routine chemistry. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on August 11, 2021 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 #1, 2021 lactate dehydrogenase-0% Event #2, 2021 lactate dehydrogenase-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 02/03/2020 found that E-lab of Florida clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Academy of Family Physicians (AAFP) proficiency testing (PT) records and interview with laboratory director (LD), the laboratory failed to have attestation signed for 3 out of 3 events reviewed for 2019 for the specialties of Chemistry and Hematology. Findings include: Review of AAFP proficiency records revealed that the laboratory failed to have a signed attestation for: -1st event of 2019 by the testing person (TP) -2nd and 3rd event 2019 by TP and LD. During an interview on 02/03/2020 at 11:30 AM, the LD confirmed that the laboratory failed to have a signed attestation for the events of reference. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory director (LD), the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- failed to attain 80 % score for T3 Uptake for 1 event out 3 events reviewed in 2019. Findings include: Review of proficiency testing records of American Academy of Family Physicians for 2019, revealed a 0 % score for T3 Uptake for the 3rd event of 2019. During an interview on 02/03/2020 at 11:30 am, the LD, confirmed that the laboratory had a 0 % score for the analyte for the event of reference. 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 the 6 months competency assessment for 1 out of 1 testing personnel (TP) in 2019. Findings include: Review of personnel files revealed that: TP had the initial competency evaluation on 2/16/2019. There was no documentation of the 6 month competency assessment for the TP later on 2019. During an interview on 02/03/2020 at 12:30 PM, with laboratory director, he confirmed that there was no documentation of the 6 month competency assessment for the TP for the period of reference. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to provide QA forms showing the laboratory was monitoring, assesing and correcting problems from December 2018 to January 2020. Findings include: -Review of Quality Assurance (QA) policy revealed that the laboratory had a Calendar of Annual Review and a QA Monitor monthly form. -No monthly QA forms available to support that the laboratory followed their QA calendar from December 2018 to January 2020. During an interview on 02/03/2020 at 1:30 PM, the laboratory director confirmed that there was no documentation of the QA for the period of reference. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system -- 2 of 4 -- performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel (TP), the laboratory failed to monitor quality control (QC) over time for shifts and trends for 1 out of 1 year reviewed (2019) for the Chemistry Analyzer AU400. Findings include: 1-Review of QC records for the AU 400 analyzer revealed only daily QC. There was no documentation of monitoring the shifts and trends of the QC over time for the QC results for the Chemistry analyzer during 2019. 2-

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 laboratory's proficiency testing records for 2018 and 2019, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Association of Family Physicians (AAFP) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on December 30, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, cholesterol HDL (high-density lipoprotein) for two out of three testing events in 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 3 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 sub-specialty of routine chemistry. Findings include: On December 30, 2019 on or about 10:00 AM the American Association of Family Physicians (AAFP) 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, HDL (high density lipoprotein) cholesterol, as shown below. Event #2, 2019 HDL cholesterol-0% Event #3, 2019 HDL cholesterol-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 routine chemistry. Findings include: On December 30, 2019 on or about 10:00 AM, the American Association of Family Physicians (AFP) 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, HDL cholesterol (high density lipoprotein), in the sub-specialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. 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; 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 -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing for the analyte, HDL (high density lipoprotein) cholesterol in the sub-specialty of routine chemistry. Findings Include: The review of the American Association of Family Physicians (AAFP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on Decemer 30, 2019 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2019 HDL cholesterol-0% Event #3, 2019 HDL cholesterol-60%. -- 3 of 3 --