Society Hill Reproductive Medicine

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on the review of personnel records and interview with the General Supervisor (GS), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor who met the qualifications specified in the Pennsylvania (PA) Clinical Lab Act from 07/06/2022 to 06/22/2023. Findings include: 1. The PA regulations (5.23 (a)(3)) states: "No person shall be a supervisor in a clinical laboratory unless he conforms with the following requirements: He shall hold a B.S. or A.B. degree from an accredited institution with a major in medical technology or one of the biological, physical or chemical sciences and shall have had at least 6 years' experience acceptable to the Department in one or more of the applicable categories in the clinical laboratory." 2. On the day of survey, 06/22/2023 at 10:39 am, review of personnel credentials revealed that 1 of 1 GS has a Bachelor of Science degree in Biology (awarded on May 09, 2020). 3. The laboratory was unable to provide the acceptable experience needed for 1 of 1 GS in order to perform the duties of a supervisor in the state of Pennsylvania. 4. The GS confirmed the findings above on 06/22/2023 around 10:50 am. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedures, competency assessment records and interview with the general supervisor (GS), the laboratory failed to establish written policies and procedures to assess the competency of 1 of 3 testing personnel (TP) performing endocrinology testing and semen analysis examinations and 1 of 1 general supervisor (GS) for their supervisory responsibilities in 2022 and 2023. Findings include: 1. On the day of the survey, 06/22/2023 at 10:59 am, the laboratory could not provide a written procedure to assess the 6-month competency during the first year of employment for 1 of 3 TP (CMS 209, personnel # 2) who started working in the laboratory on July 6, 2022. 2. The laboratory could not provide competency assessment records for 1 of 1 GS for their supervisory responsibilities in 2022 and 2023. 3. The GS confirmed the findings above on 06/22/2023 around 12:30 pm. * Repeat deficiency. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the validation records, the manufacturer's package inserts (PI), database search and interview with the General Supervisor (GS), the laboratory failed to establish--before reporting patient test results-complete performance specifications for Sperm DNA Fragmentation testing using the Halosperm HT-HS10 kit (manufacturer: Halotech) from October 2022 to June 2023. Findings include: 1. On the day of survey, 06/22/2023 at 11:47 am, review of the validation records, the manufacturer's package inserts (PI), and observation of laboratory kits revealed that the laboratory was performing a diagnostic test using the Halosperm HT-HS10 kit which is not an FDA-approved test system. 2. Before patient samples were analyzed, the laboratory did not establish performance specifications of accuracy, precision, analytical sensitivity, analytical specificity, reportable range and reference intervals (normal values). 3. The GS confirmed the findings above on 06/22/2023 at 01:40 pm. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the -- 2 of 4 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the General Supervisor (GS), the laboratory failed to include the required disclaimer on patient reports stating that the test developed for the Sperm DNA Fragmentation testing was not approved or cleared by the U.S Food and Drug Administration (FDA) from November 2022 to the date of survey. Findings include: 1. On the day of survey, 06/22/2023 at 12:49 pm, a review of 2 of 2 test reports revealed the test reports did not include the required disclaimer stating that the test developed for the Sperm DNA Fragmentation testing (Halotech) was not approved or cleared by the FDA from November 2022 to June 2023. 2. The GS confirmed the finding above on 06/22/2023 at 01:40 pm. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter Access 2 analyzer validation records and interview with the General Supervisor (GS), the Laboratory Director (LD) failed to ensure that the performance specification procedures used to determine the accuracy, precision, linearity, and comparison studies for Anti-Mullerian Hormone (AMH) testing performed on the Beckman Coulter Access 2 analyzer were adequate before reporting patient test results from April 2023 to May 2023. Findings include: 1. On the day of survey, 06/22/2023 at 11:24 am, review of the validation records revealed that the validation performed on February 2023 did not include the laboratory's acceptable criteria for performance specifications for precision, accuracy, reportable ranges, and comparison studies for Anti-Mullerian Hormone (AMH). 2. Record review revealed that the LD did not review and approve the validation for the Beckman Coulter Access 2 analyzer performed in February 2023. 3. The GS confirmed the finding above on 06/22/2023 at 01:40 pm. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the quality control (QC) records, lack of documentation, and interview with the General Supervisor (GS), the laboratory director (LD) failed to -- 3 of 4 -- ensure that a QC program was established and maintained to ensure the quality of services provided for 1 of 2 hematology tests performed from November 2022 to the date of survey. Findings include: 1. On the day of the survey, 06/22/2023 at 12:30 pm, the laboratory could not provide documentation of the negative QC performed for the following 1 of 2 hematology tests performed from November 2022 to 06/22/2023: - Sperm DNA fragmentation via sperm chromatin dispersion 2. The GS confirmed the finding above on 06/22/2023 at 01:40 pm. -- 4 of 4 --

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 American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with the General Supervisor (GS) and consultant, the laboratory failed to have attestation statements provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples for endocrinology were tested in the same manner as patient specimens in 2019 and 2020. Findings Include: 1. On the day of survey, 07/21/2021, the following AAB PT attestation statements for endocrinology were not signed by the analyst and the laboratory director in 2019 and 2020: - 2019 Event # 1, 2 and 3. - 2020 Event #2. 2. The AAB PT attestation statements for the 2020 events #1, #3 and 2021 event #1, were signed by 2 of 2 testing personnel not delegated as a designee. 3. The GS confirmed the findings above on 07/21/2021 around 10:35 am. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 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 -- The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with the general supervisor (GS) and consultant, the laboratory failed to establish a complaint policy and document problems reported to the laboratory from 2019 to the day of survey. Findings include: 1. On the day of survey, 07/21/2021, the laboratory could not provide a complaint policy in place that describes how complaints and problems reported to the laboratory are handled from 07/21/2019 to 07/21/2021. 2. The GS confirmed the finding above on 07/21/201 around 10:25 am. 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 review of laboratory procedures and interview with the general supervisor (GS) and consultant, the laboratory failed to establish a complete competency assessment procedure to assess the competency of 3 of 3 testing personnel (TP) performing endocrinology testing and semen analysis examinations and 1 of 1 general supervisor (GS) for their supervisory responsibilities in 2019 and 2020. Findings include: 1. The Individual Performance Improvement Policy states, "All employees will be evaluated annually by direct observation by the laboratory director". 2. On the day of survey, 07/21/2021, the laboratory could not provide a complete competency assessment procedure to assess the competency of 3 of 3 TP performing endocrinology testing, semen analysis examinations and 1 of 1 GS for their supervisory responsibilities from 07/21/2019 to 07/21/2021. 3. Review of TP records revealed, TP #2 and #3 were not assessed for competency in 2019 and 2020. 4. Review of 2021 competency assessment records revealed, the 6 point of competency were not assessed for each test system performed by each TP. 5. The GS confirmed the findings above on 07/21/201 around 9:35 am. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with general supervisor (GS) and -- 2 of 3 -- consultant, the laboratory director failed to specify in writing the responsibilities and duties for 3 of 3 testing personnel (TP) and 1 of 1 GS prior to reporting patient test results from 2019 to the day of survey. Findings Include: 1. On the day of survey, 07 /21/2021, the laboratory could not provide in writing the responsibilities and duties for 3 of 3 TP performing endocrinology and semen analysis testing and for 1 of 1 GS their duties performed form 07/21/2019 to 07/21/2021. 2. The GS confirmed the finding above on 07/21/201 around 10:25 am. -- 3 of 3 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of