Finlay Clinical Laboratory Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 21 to September 27, 2023. Finlay Clinical Laboratory Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Condition was cited: D5400 Analytic Systems 493.1250 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observations, review of Material Safety Data Sheets (MSDS), and interview the laboratory failed to have exposure testing for Formalin and Xylene for 2 out of 2 years (2021-2023) reviewed. Findings Included: During a tour of the Histology and Cytology Departments on 08/22/2023 at 9:00 AM Formalin (Lot# 2317310 exp 06/26 /2025) and Xylene (Lot#2315131 exp 06/01/2027) were observed. Review of the MSDS for Formalin (revision date 10/29/2009) under "HAZARDOUS COMPONENTS AND EXPOSURE LIMITS" revealed the components of Formalin are Formaldehyde and Methanol. The exposure limit for Formaldehyde is 0.75 PPM (parts per million) and for Methanol is 200 PPM. Review of the MSDS for Xylene (revision 11/23/2009) under "HAZARDOUS COMPONENTS AND EXPOSURE LIMITS" revealed the exposure limit for Xylene is 100 PPM. Interview on 08/22 /2023 at 9:00 AM the Histotech confirmed that there was no exposure testing performed in 2021-2023. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observations, record review, and interviews the Laboratory failed to run negative controls for Giardia/Cryptosporidium and C. Diff testing (See D5441), failed to run quality control before Patients were ran (See D5481), and failed to have

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on June 16, 2022 for Finlay Clinical Laboratory. Finlay Clinical Laboratory 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 did not have successful performance in proficiency testing for analytes in the subspecialty of general Immunology. Refer to D2084. Findings include: Review of the College of American Pathologists (CAP) proficiency testing records and 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 -- review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on June 16, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the following analytes: alpha 1 anti-trypsin, Complement component 3 (C3), IgA (immunoglobulin A), IgG (immunoglobulin G) for two consecutive testing events in 2021 and 2022. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 for analytes in the subspecialty of general immunology. Findings include: On June 16, 2022 on or about 10:00 AM the College of American Pathologists (CAP) 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 analytes that are listed below. Event #3, 2021 Alpha 1 anti-trypsin-60% Complement component 3 (C3)-40% IgA-40% IgG-60% Event #1, 2022 Alpha 1 anti-trypsin-40% Complement component 3 (C3)-40% IgA- 40% IgG-60% 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 in proficiency testing for analytes found in the subspecialty of general immunology. Findings include: On June 16, 2022, on or about 10:00 AM, the College of American Pathologists (CAP) 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 consecutive testing events for the analytes; alpha 1 anti-trypsin, complement component 3, IgA, and IgG, in the subspecialty of general immunology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2084. 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. -- 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 for analytes found in the subspecialty of general immunology. Findings Include: The review of the College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on June 16, 2022, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events for the analytes shown below. Event #3, 2021 Alpha 1 anti-trypsin-60% Complement component 3 (C3)-40% IgA-40% IgG-60% Event #1, 2022 Alpha 1 anti-trypsin-40% Complement component 3 (C3)-40% IgA-40% IgG-60% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/05/2021 to 10/06/2021 found the FINLAY CLINICAL LABORATORY INC not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report 26,240 test results to Florida Department of Health (FDOH) from 03/09/2021 to 09/30/2021. The laboratory performed 24,837 nucleic acid amplification (NAAT) tests using Aptima Hologic test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), 733 SARS-CoV-2 S1/S2 Immunoglobulin G (IgG) and 670 Immunoglobulin M (IgM) to SARS-COV-2 tests with Liaison DiaSorin test kit. Findings include: -Review of the FDOH notification records, revealed the laboratory was notified on 03/09/2021 that their reporting system was not communicating with the FDOH SARS-COV-2 reporting system and while their system entered in production phase, they will have to report daily by fax. -Review of the fax records sent to the FDOH revealed the laboratory failed to report 24,837 results for NAAT Aptima Hologic test for detection of SARS-COV-2, 733 SARS-CoV-2 S1/S2 IgG 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 -- results and 670 IgM SARS-COV-2 results using Liaison DiaSorin tests from 03/09 /2021 to 09/30/2021. During an interview on 10/05/2021 at 2:00 PM, the Technical Supervisor (TS) explained that the laboratory had been working with the FDOH Electronic Reporting System (ELR) group since they received the notification and confirmed the laboratory failed to report the cases listed above for the period of reference because they understood they could do a back log report after the ELR system was set up. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated. Findings include: Review of QFT- Plus Instructions for Use stated "Tubes must be transferred to a 37 Celsius (C) 1C incubator within 2 hours. If QFT-Plus Blood Collection Tubes are not incubated at 37 C directly after blood collection and shaking, invert the tubes to mix 10 times (10x) prior to incubator at 37 C. Incubate the QFT-Plus Blood collection tubes upright at 371 C for 16 to 24 hours. In order to obtain valid results from the QFT-Plus assay, the operator needs to perform specific tasks within set times. Prior to harvesting plasma, samples in QFT-Plus Blood Collection Tubes must have been incubated at 37 C for 16-24 hours." QFT-Plus Blood Collection Tubes also contain the following controls: Nil (the negative control) and mitogen (the positive control). Review of QuantiFERON Incubator logs revealed the laboratory was not documenting the collection time and incubation in and out time for QFT blood specimens from 01/01 /2020 to 10/06/2021. During an interview on 10/06/2021 at 12:00 PM, the Technical Supervisor (TS) confirmed laboratory failed to follow manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of specimen received and incubated. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/05/2021 to 10/06/2021 found the FINLAY CLINICAL LABORATORY INC is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: -D3000. Facility Administration. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report 26,240 test results to Florida Department of Health (FDOH) from 03/09/2021 to 09/30/2021. The laboratory performed 24,837 nucleic acid amplification (NAAT) tests using Aptima Hologic test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), 733 SARS-CoV-2 S1/S2 Immunoglobulin G (IgG) and 670 Immunoglobulin M (IgM) to SARS-COV-2 tests with Liaison DiaSorin test kit. Findings include: -Review of the FDOH notification records, revealed the laboratory was notified on 03/09/2021 that their reporting system was not communicating with the FDOH SARS-COV-2 reporting system and while their system entered in production phase, they will have to report daily by fax. -Review of the fax records sent to the FDOH revealed the laboratory failed to report 24,837 results for NAAT 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 -- Aptima Hologic test for detection of SARS-COV-2, 733 SARS-CoV-2 S1/S2 IgG results and 670 IgM SARS-COV-2 results using Liaison DiaSorin tests from 03/09 /2021 to 09/30/2021. During an interview on 10/05/2021 at 2:00 PM, the Technical Supervisor (TS) explained that the laboratory had been working with the FDOH Electronic Reporting System (ELR) group since they received the notification and confirmed the laboratory failed to report the cases listed above for the period of reference because they understood they could do a back log report after the ELR system was set up. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated. Findings include: Review of QFT- Plus Instructions for Use stated "Tubes must be transferred to a 37 Celsius (C) 1C incubator within 2 hours. If QFT-Plus Blood Collection Tubes are not incubated at 37 C directly after blood collection and shaking, invert the tubes to mix 10 times (10x) prior to incubator at 37 C. Incubate the QFT-Plus Blood collection tubes upright at 371 C for 16 to 24 hours. In order to obtain valid results from the QFT-Plus assay, the operator needs to perform specific tasks within set times. Prior to harvesting plasma, samples in QFT-Plus Blood Collection Tubes must have been incubated at 37 C for 16-24 hours." QFT-Plus Blood Collection Tubes also contain the following controls: Nil (the negative control) and mitogen (the positive control). Review of QuantiFERON Incubator logs revealed the laboratory was not documenting the collection time and incubation in and out time for QFT blood specimens from 01/01 /2020 to 10/06/2021. During an interview on 10/06/2021 at 12:00 PM, the Technical Supervisor (TS) confirmed laboratory failed to follow manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of specimen received and incubated. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted, 9/23-24/2019 found that Finlay Clinical Laboratory Inc., clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 of College of American Pathologists (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80 % on Immunoglobulin M (IgM) for one (3rd event of 2017) out of six (2017 3rd; 2018 1st, 2nd and 3rd; 2019 1st and 2nd) events for General Immunology specialty reviewed. Findings include: Review of CAP proficiency records revealed a score of 20 % for IgM in the 3rd event of 2017. During an interview on 09/23/2019 at 3:30 PM, the TS confirmed the failed proficiency testing score. 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 of College of American Pathologists (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80 % on Calcium (Ca) and Creatine Kinase Isoenzymes (CK-Iso) for 1 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 -- (2nd event of 2019) out of 6 (2017 3rd; 2018 1st, 2nd and 3rd; 2019 1st and 2nd) events for Routine Chemistry specialty reviewed. Findings include: Review of CAP proficiency records revealed a score of 40 % for Ca and 60 % for CK-Iso in the 2nd event of 2019. During an interview on 09/23/2019 at 3:30 PM, the TS confirmed the failed proficiency testing score. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 of College of American Pathologists (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80 % on Thyroxine (Ty) for 1 (2nd event of 2019) out of 6 (2017 3rd; 2018 1st, 2nd and 3rd; 2019 1st and 2nd) events reviewed for Endocrinology specialty. Findings include: Review of CAP proficiency records revealed a score of 60 % for Ty in the 2nd event of 2019. During an interview on 09/23/2019 at 3:30 PM, the TS confirmed the failed proficiency testing score. -- 2 of 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, the laboratory did not have successful performance in proficiency testing for the subspecialty of parasitology. Refer to D2055. 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 January 14, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the subspecialty of parasitology, for two out of three testing events in 2018. 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 -- D2055 PARASITOLOGY CFR(s): 493.829(e) 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 did not have successful participation in proficiency testing for the subspecialty of parasitology. Findings include: On January 14, 2019 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 subspecialty of parasitology as shown below. Event #1, 2018 Parasitology-60% Event #3, 2018 Parasitology-75% 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 parasitology. Findings include: On January 14, 2019, 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 subspecialty of parasitology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2055. 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 the subspecialty of Parasitology. 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 January 14, 2019 on or -- 2 of 3 -- about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores in the subspecialty of Parasitology as shown below. Event #1, 2018 parasitology-60 % Event #3, 2018 parasitology-75%. -- 3 of 3 --

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 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of toxicology. Refer to D2118. 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 June 20, 2018 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, gentamicin and digoxin for two out of three testing events in 2017 and 2018. 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 -- D2118 TOXICOLOGY CFR(s): 493.845(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 participation in proficiency testing for the subspecialty of toxicology. Findings include: On June 20, 2018 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 analytes, gentamicin and digoxin, as shown below. Event #2, 2017 gentamicin-40% digoxin-20% Event #1, 2018 gentamicin-40% digoxin-20% 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 toxicology. Findings include: On June 20, 2018, 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 analytes, gentamicin and digoxin, in the subspecialty of toxicology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2118. 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 manner as to achieve and maintain successful participation in proficiency testing in -- 2 of 3 -- the subspecialty of toxicology. 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 June 20, 2018 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2017 gentamicin-40% digoxin-20% Event #1, 2018 gentamicin-40% digoxin-20% -- 3 of 3 --