Fertility Center Llc

Summary Statement of Deficiencies D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on the review of competency assessment records and interview with the Laboratory Manager and Andrologist, the Technical Supervisor failed to include assessment of problem solving skills in 3 of 3 Testing Personnel competency assessments reviewed. Findings: 1. The assessment of problem solving skills is one of requirements for Testing Personnel CLIA competency assessment. 2 On the date of survey 10/20/2020, competency record review revealed problem solving skills were not included in the competency assessment of 3 of 3 records reviewed. 2) During the survey, the Laboratory Director confirmed the findings 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 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 laboratory quality assurance (QA) policy, laboratory QA document, and interview with the laboratory technical supervisor (TS) #2, the laboratory failed to document monthly QA reviews in 2018. Findings include: 1. The laboratory QA policy (the laboratory director signed off on 04/01/2018) states during the month, the laboratory will monitor care indicators and record any findings, including

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 February 01, 2018 review of CASPER 155 Report and performance evaluations from the proficiency testing organization, College of American Pathologist (CAP) the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyst: HCG of the speciality Endocrinology. The laboratory had unsatisfactory scores for the 1st and 3rd event of 2017. See D2107 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 February 01, 2018 review of CASPER 155 Report and performance evaluations from the proficiency testing organization, College of American Pathologist (CAP) the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyst: hCG of the speciality Endocrinology. The laboratory had unsatisfactory scores for the 1st and 3rd event of 2017. Findings Include: 1. CAP 2017 Event 1 HCG score 20% 2. CAP 2017 Event 3 HCG score 0% -- 2 of 2 --