New Hope Fertility Center

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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2022 second event = 60% 2022 third event = 100% 2023 first event = 40% This is considered unsuccessful PT performance. Refer to D2107 D2099 ENDOCRINOLOGY 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 -- CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the AAB- MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test specialty Endocrinology. The following scores were assigned: 2023 first event = 70% This is considered unsatisfactory PT performance 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the AAB- MLE PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2022 second event = 60% 2022 third event = 100% 2023 first event = 40% This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT and AAB-MLE PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Endocrinology and the test analyte TSH 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT and AAB-MLE PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Endocrinology and the test analyte TSH The following scores were assigned: Specialty Endocrinology 2023 first event = 70% This is considered unsatisfactory PT performance. TSH 2022 second event = 60% 2022 third event = 100% 2023 first event = 40% This is considered unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of Center for Medicaid and Medicare Service (CMS) PT report, the laboratory failed to enroll in an approved PT program for the specialities Endocrinology and Hematology for the calendar year 2019. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a PT desk review of CMS PT reports, the laboratory director failed to ensure 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 -- that the laboratory was enrolled in an approved PT program for the speciality Endocrinology and Hematology for the calendar year 2019 Refer to D2000. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the quality control (QC) records for the Horiba Pentra 60 C hematology analyzer and interview with the laboratory director and testing person, the laboratory failed to retain copies of the instrument maintenance records. Findings Include: It was confirmed by laboratory director and testing person on November 29, 2018 at approximately 1:30 pm, that the laboratory failed to retain the pass/fail maintenance records for the Horiba Pentra 60 C from the time of the last survey (June 1, 2017) through the date of this survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of personnel competency procedures, records and an interview with the laboratory director and testing person, the laboratory failed have complete policies and procedures to assess employees competency. Finding Include: At approximately 11:30 am on November 29, 2018, the laboratory failed to have procedures for direct observation of routine patient test performance (including patient 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 -- preparation, if applicable, specimen handling, processing and testing); and the performance of instrument maintenance and function checks. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)