Alabama Center For Reproductive Medicine, Pllc

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 reviews of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records for the sperm count analysis, the performance evaluation records and an interview with the Testing Personnel (TP), the laboratory had not successfully participated and implemented effective

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with Testing Personnel #1, the Laboratory Director failed to sign the attestation statement provided by American Association of Bioanalyst (AAB). This was noted for two out of two events reviewed from the start of patient testing, August 2022, to the date of the current survey, October 17, 2023. The findings include: 1. A review of PT records revealed attestation statements with no evidence of signatures by the Laboratory Director for Event S2 2022 or Event S1 2023. 2. During an interview on 10/17/2023 at 2:00 PM, Testing Personnel #1 confirmed the above findings. 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 --