Amz Laboratory

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte Thyroxine, Free. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: Free Thyroxine (F4). The laboratory had unsatisfactory scores for the 2nd event of 2021 and the 3rd event of 2021. Findings include: Analyte Year Event Score F4 2021 2 40%. F4 2021 3 0%. 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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to achieve an overall testing score of satisfactory performance in the subspecialty Endocrinology. The laboratory had unsatisfactory scores for the 2nd event of 2021, and 3rd event of 2021. Findings include: Subspecialty Year Event Score Endocrinology 2021 2 70% Endocrinology 2021 3 0% -- 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 a review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analytes: Triiodothyronine (TT3), Thyroxine (TT4) and the subspecialty Endocrinology. The laboratory had unsatisfactory scores for the 3rd event of 2019 and the 1st event of 2020. See D2107 and 2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- 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 a review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analytes: Triiodothyronine (TT3) and Thyroxine (TT4). The laboratory had unsatisfactory scores for the 3rd event of 2019 and the 1st event of 2020. Findings Include: AAB - TT3: Event 3 in 2019 = 0%. AAB - TT3: Event 1 in 2020 = 0%. AAB - TT4: Event 3 in 2019 = 0%. AAB - TT4: Event 1 in 2020 = 0%. 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 a review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance in the subspecialty Endocrinology and has sustained a subsequent occurrence of unsuccessful participation scores for the 3rd event of 2019 and the 1st event of 2020. Findings Include: AAB Endocrinology - 2019 Event #3- 50%. AAB Endocrinology - 2020 Event #1- 50%. subspecialty Faliure PT Desk Audit -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with the testing personnel (TP), the laboratory failed to examine and test AAB PT routine chemistry and hematology samples in the same manner as patient specimens from 2018 to the date of survey. Findings Include: 1. On the day of survey, 10/31/2019, the surveyor asked if AAB routine chemistry and hematology PT samples are run the same as patient specimen? The TP stated "No, they calibrate the instrument before PT samples are analyzed and PT samples are run in duplicate. 2. The TP confirmed patient specimens are not run in duplicate and calibration is performed by manufactures procedures on 10/31/2019 around 9:33 am. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals and interview with testing personnel (TP), the laboratory failed to establish a competency assessment (CA) procedure to assess the competency of 1 of 1 TP performing Microscopic urinalysis examinations, complete blood count testing (CBC) and clinical chemistry testing in 2018 and 2019. Findings Include: 1. On the day of survey, 10/31/2019, the laboratory failed to provide a written CA procedure to assess the competency of 1 of 1 testing personnel (TP) performing microscopic urinalysis examinations, CBC's tests on the Sysmex XP 300 analyzer and clinical chemistry testing performed on the Cobas Integra 400 analyzer in 2018 and 2019. 2. The TP confirmed the findings above on 10 /31/2019 around 10:00 am. 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 review of the laboratory procedure manuals and interview with the testing personnel (TP), the laboratory failed to establish a written quality assessment (QA) policy and procedure for ongoing mechanisms to monitor, assess, and, when indicated, correct problems identified for the laboratory from 2018 to the day of survey. Findings Include: 1. On the day of survey, 10/31/2019, review of the laboratory's manuals revealed that the laboratory did not to have a written policy for how to assess the quality of its laboratory systems. 2. The TP confirmed the laboratory does not a have quality assessment procedure on 10/31/2019 around 10:10 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)