Ip Eugene 1

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based upon review of Calibration Verification records for May 2021 and discussion with the Laboratory Director (LD), the laboratory failed to perform recalibration after Calibration Verification failed May 12, 2021. Findings include: 1. Upon review of the Calibration Verification performed on the Cobas E411 Endocrinology instrument, it was revealed that the Testosterone Calibration Verification failed the accuracy test and the reportable range test using the EP Evaluator software program used by the laboratory. 2. The LD concurred that re-calibration was not performed after the system failures noted above were reviewed during interview on 09/07/2021 at approximately 2 pm. 3. The LD signed off on the Calibration Verification for Testosterone on May 13, 2021 without noting any

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: Record review of the American Proficiency Institute (API) proficiency testing revealed that your laboratory had unsuccessful proficiency testing for Endocrinology. Refer to D2107. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Record review of proficiency testing from American Proficiency Institute (API) revealed that your laboratory had unsuccessful performance for two out of three consecutive testing events for the analyte Thyroid Stimulating Hormone(TSH) . The findings include: 1. 3rd Event 2019 Thyroid Stimulating Hormone - 60% 2. 2nd Event 2020 Thyroid Stimulating Hormone - 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 review of reecords and discussion with the Technical Consultant (TC) and testing personnel (TP), the laboratory failed to ensure calibration and calibration verification were performed on the requisite instruments in Hematology and Chemistry every six (6) months. Findings include: 1. The Hematology analyzer Coulter DXH 600 was last calibrated 06/06/2019. The calibration prior was done eight months before this 10/09/2018, two months late. 2. The Endocrinolgy analyzer Cobas 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 -- e411 serial # 115422 was last calibrated for Estradiol, Follicle Stimulating Hormone (FSH), Leutinizing Hormone (LH), Progesterone, Thyroid Stimulating Hormone (TSH), and Testosterone between 10/11/2018 and 10/19/2018. 3. The TC and the TP present during interview 6/24/2019 at approximately 1230 confirmed this was the last time of calibration for both instruments. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) records for Microbiological media and discussion with the Laboratory Director (LD), the laboratory failed to perform end user QC on the media used to plate urine cultures. Findings include: 1. The culture media used by the laboratory to plate urine cultures contains two types of media classified as differential (Blood Agar) and inhibitory (MacConkey Agar). No written documentation of QC for either media type could be produced during the survey 06/24 /2019. 2. The LD confirmed during interview 06/24/2019 at approximately 1330 that they were not currently performing QC on the media in this lab. -- 2 of 2 --