Columbus Center For Reproductive

Summary Statement of Deficiencies D0000 D000 A proficiency testing desk review was completed on July 7, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Human Chorionic Gonadatropin (HCG) in 2023 event 3 and 2024 event 2, resulting in an initial unsuccessful participation for HCG. Refer to D 2108 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in 2 of 3 testing events ( 3rd event of 2023 and 2nd event of 2024), resulting in an initial unsuccessful participation for HCG. Findings: 1. A review of Casper Report 155 revealed the laboratory failed HCG on the following: 2023 Event 3 Score 60% 2024 Event 2 Score 0% 2. A review of the laboratory's API Reports confirmed the laboratory failed HCG with the aforementioned scores. 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 review of the CMS CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2023 event 3 and 2024 event 2 PT evaluation reports, the laboratory -- 2 of 3 -- director failed to ensure successful proficiency testing performance in HCG in two out of three testing events resulting in the initial unsuccessful participation for HCG. Refer to D 2108 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on December 26, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the 2018 and 2019 maintenance schedules for the TOSOH AIA- 900 chemistry analyzer(TOSOH), and staff interview, the laboratory failed to document Quarterly and Monthly Maintenance as required by the manufacturer. Findings: 1. Review of the maintenance schedules for the TOSOH showed that the laboratory did not document quarterly maintenance for five months in 2018, and monthly maintenance for one month in 2018. In 2019 the laboratory failed to document monthly maintenance for two months and one month no maintenance was marked. Also confirmed that the laboratory switched back to the TOSOH AIA-600 maintenance schedule in May of 2018. January through April 2018, quarterly maintenance was not marked as being completed May 2018 switched back to TOSOH AIA-600 maintenance schedule November 2018, monthly maintenance was not marked as being completed February and March 2019, monthly maintenance was not marked as being completed April 2019, no maintenance was marked as being completed 2. Interview with the TC, and staff #3 (CMS 209 form) on December 26, 2019, at approximately 1 pm, in exam room 1, confirmed that the maintenance was not marked as being performed as stated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 8, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 surveyor review of calibration records of testing performed on the Tosoh 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 -- AIA-900 Automated Immunoassay Analyzer and interview with the testing personnel (TP), the laboratory failed to perform and document calibration verification of the three analytes using less than a three point calibration, Beta Human Chorionic Gonadotropin, (BHCG), Follicle Stimulating Hormone, (FSH), and Prolactin, at least once every 6 months. The findings include: 1. Calibration records for BHCG, FSH, and Prolactin performed on the Tosoh AIA-900 Automated Immunoassay Analyzer revealed calibration does not contain at least 3 points including a zero, midpoint and high value near the cut-off range. 2. Review of calibration records from June 2017 through January 2018 revealed no documentation showing calibration verification for BHCG, FSH, and Prolactin was performed at least once every 6 months. 3. TP #2 (see CMS 209) confirmed on 2/8/18 at 10:30AM, in a holding area, that the laboratory did not document or perform calibration verification or use 3 levels of calibration materials for BHCG, FSH, and Prolactin performed on the Tosoh AIA-900 Automated Immunoassay Analyzer from June 2017 through January 2018. -- 2 of 2 --