Life Ivf Center Los Angeles

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) College of American Pathologists (CAP) records and policy and interview with the testing personnel, the laboratory failed to document the handling, preparation, processing, examination, and each step in the testing, reporting, testing failures, and

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, patient, quality control and proficiency testing records for the years of 2019 and 2020, and interview with the laboratory testing person # 1 on September 11, 2020 at 11:50 am, the laboratory failed to evaluate its proficiency testing performance for the quantitative results of the analyte hCG, for 4 events out of 4 events, reviewed. The findings include: 1. The laboratory participated CAP proficiency testing program in the year of 2019 and 2020 for its quantitative hCG test which is done on Tosoh AIA-900 instrument. However, it did not evaluate its proficiency testing performance upon receiving no score from CAP due to insufficient peer group data. Therefore, the accuracy of the laboratory's test results to the patients for quantitative hCG test can not be assured. a. The laboratory participated CAP proficiency testing program for the events of S-A 2019, S- B 2019, S-C 2019 and S-A 2020. However, CAP did not grade laboratory's results due to insufficient peer group data. b. The laboratory director reviewed the ungraded report from CAP but did not evaluate its own performance by verifying the accuracy of its results for the quantitative hCG test. 2. The laboratory testing person # 1 on September 11, 2020 at 11:50 am, affirmed that the laboratory did not evaluate its own performance by verifying test accuracy for the quantitative hCG test. 3. The laboratory's testing declaration form, signed by the laboratory director on 9/3/2020, stated that the laboratory performs 296 quantitative hCG tests, annually. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require