Pacific Reproductive Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on -07/15/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful AAB-Medical Laboratory Evaluation participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2024-3 and 2025-1), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the specialty Endocrinology resulting in unsuccessful performance. See D2108. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2024-3 and 2025-2) for the specialty Endocrinology: The finding include: Endocrinology 40% - 2024 third testing event; Endocrinology 72% - 2025 second testing event. A review of the 2024 & 2025 scores from AAB confirmed the above findings. 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 a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-3 and 2025-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-3 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2108. -- 2 of 2 --

Summary Statement of Deficiencies D2099 ENDOCRINOLOGY 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 the review of the American Association of Bioanalysts (AAB) proficiency testing reports, review of five (5) randomly selected patient result records from 2/19 /2021 to 5/27/2022, and interview with the laboratory's technical supervisor (TS) and testing person (TP), the laboratory failed to attain a score of at least 80 percent for Endocrinology for Human Chorionic Gonadotropin (hCG) for the first event of 2022 (Q1-2022). The findings included: 1. AAB reported for Q1-2022 a score of 60% for the analyte hCG. 2. The TS and TP confirmed on June 7, 2022, at approximately 11: 45a.m. that the laboratory had failed to attain a proficiency score of at least 80 percent for the analyte hCG. 3. Based on the laboratory's annual test volume declaration signed by the laboratory director on 05/24/2022 the laboratory analyzed and reported approximately 2,500 Endocrinology tests which include hCG. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's policy & procedures and proficiency testing records, and interview with the laboratory technical supervisor on June 7, 2022; it was determined that the laboratory director, failed to ensure that PT samples 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 -- for Endocrinology for the first event of 2022 were tested as required under subpart H. of this part. See D2099. -- 2 of 2 --

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient, quality control (QC) and proficiency testing (PT) records for the years of 2019 and 2020, and interview with the laboratory testing person (TP) on November 23, 2020 at 12:05 pm, the laboratory failed to attain a score of at least 80 percent of acceptable responses for Human Chorionic Gonadotropin (hCG) at 1 testing event out of 4 events, reviewed. The findings include: 1. The laboratory participated in the AAB PT program for the years of 2019 and 2020. It received a score of 60% for the analyte hCG at the 1st event in 2019. 2. The laboratory TP on November 23, 2020 at 12:05 pm, affirmed that the laboratory did not receive at least 80% score for hCG at the 1st event in 2019. 3. The laboratory's testing declaration form, signed by the laboratory Director on 11/20 /2020, stated that the laboratory performs 24,000 tests in endocrinology, annually. D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, proficiency testing (PT) performance review and

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control data and random patient testing records, and interview with the laboratory manager and staff, the laboratory staff failed to follow the lab director's approved procedure for semen analysis. The findings include: a. The laboratory's sperm count procedure in the andrology lab manual, page 4 and 5, states that the sperm count should be repeated with another drop of the specimen to determine the average count, and the agreement limit between replicate counts should be less than 10%. However, the laboratory failed to provide any document showing that the patients' sperm specimen, Accession # 111017-902 and 032118-207, were counted by repeating with another drop of the specimen. Due to the lack of repeated analytic test records, it could not be assured that the test was repeated, and the reported test result for the above patients was accurate. b. On May 25, 2018 at 2:10 pm laboratory manager and staff affirmed that the laboratory did not have any analytic records for the above patients showing that the sperm count was performed by repeating the count with another drop of the specimen. c. The laboratory's testing declaration form, signed by the laboratory Director on May 25, 2018, stated that the laboratory performs 450 semen analysis tests annually. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test 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 -- methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory procedure and patient testing records, lack of analytical test records, and interview with the laboratory manager and staff, the laboratory Director failed to ensure that the laboratory personnel are performing the test methods as required for accurate and reliable results. The findings include: a. See D5401 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 Surveyor review of laboratory's policy and procedure, lack of approved written documentation, and interview with the laboratory manager, the laboratory Director failed to assign, in writing, the duties/responsibilities to each person involved in all phases of the testing process. The findings include: a. The laboratory has a licensed CLS, few unlicensed personnel and a consultant who are involved in patient management and laboratory testing, however, the laboratory director had not assigned, in writing, to any person of their responsibilities and duties. b. On May 25, 2018 at 3: 15 pm laboratory manager and staff affirmed that the laboratory director did not assign duties/responsibilities, in writing, to personnel. c. The laboratory's testing declaration form, signed by the laboratory Director on May 25, 2018, stated that the laboratory performs 2750 tests annually. -- 2 of 2 --