Institute Of Reproductive

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: A) Based on surveyor review of Proficiency Testing (PT) records and interview with the General Supervisor 1 (GS1), the laboratory failed to evaluate coded results obtained from the College of American Pathologists (CAP) for Sperm Morphology & Motility Online events A and B in calendar year 2023. The finding includes: 1. The laboratory failed to evaluate Code 26 (Educational Challenge) response from CAP for Sperm Morphology & Motility Online in events A and B of 2023. 2. The CAP reports were written "See attached" but no evaluation was attached. 3. The GS1 as stated on the CMS 209 form confirmed on 9/11/24 at 11:00 am that the laboratory failed to evaluate coded results for Sperm Morphology & Motility. B) Based on surveyor review of PT records and interview with the GS1, the laboratory failed to evaluate coded results obtained from the CAP for Semen Analysis for event A in calendar year 2024. The finding includes: 1. The laboratory failed to evaluate Code 26 (Educational Challenge) response from CAP for Semen Analysis 2. The GS confirmed on 1/30/24 at 11:00 am that the laboratory failed to evaluate coded results for Sperm Morphology & Motility. Note: The laboratory was previously cited for this deficiency on 2/7/23. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) 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 records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), and interview with the General Supervisor 1 (GS1), the laboratory failed to maintain an accurate record system for Semen Analysis from 11/10/23 to 9/11/24. The findings include: 1. Review of the semen analysis AL revealed that the following samples had no times processed entered on the AL: a) S24-0906-3 b) S23-0827-4 c) S23-1007-4 d) S24-0911-11 2. The GS1 as listed on CMS form 209 confirmed on 9/11/24 at 11:25 am, the laboratory did not maintain an accurate record system. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that 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 surveyor review of the Performance Specification (PS) records and interview with the General Supervisor (GS1) the LD failed to ensure that PS were adequate to perform Endocrinology tests performed on the Cobas Pro-e88 analyzer from 11/1/23 to 9/11/24. The findings include: 1. There was no documented evidence the LD approved and signed the PS for the Cobas Pro-e88 analyzer before it was used for patient testing. 2. The GS1 as stated on the CMS 209 form confirmed on 9/11/24 at 11:15 am, the LD failed to approve the PS before the instrument was put into use. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: All proficiency testing evaluation and verification activities must be documented. Based on surveyor review of Proficiency Testing (PT) results and interview with the General Supervisor (GS), the laboratory failed to review coded results for Sperm Morphology & Motility and Semen Analysis Testing performed with the College of American Pathologists (CAP) in the calendar years 2021 an 2022. The findings include: 1. The laboratory received a coded result (Code 26 -Educational Challenge) for Forward Progression No in event SPCD-A 2022 specimens SPCD-01 and SPCD- 02. 2. The laboratory received a coded result (Code 20 -No appropriate target /response cannot be graded) for Anti-Sperm Ab in event SEM-A 2022 specimens SEM-07 and SEM-09 and event SEM-A 2021 specimen SEM-08. 3. The laboratory received a coded result (Code 27 - Lack of participation or referee consensus) for Anti- Sperm Ab in event SEM-A 2021 specimens SEM-07. 4. There was no documented evidence that coded PT results were reviewed. 5. The GS confirmed on 2/7/23 at 11: 15 am that the laboratory did not review coded PT results. . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 observation of the Bio-Rad Lyphochek Immunoassay Plus Controls Manufacturers Package Insert (MPI), Control Values (CV) in the COBAS Analyzer and interview with the General Supervisor (GS), the laboratory failed to follow MPI for control values on the date of survey. The findings include: 1) MPI for Bio-Rad Lyphochek Immunoassay Plus Controls Lot 40420 had CV as follows: a. Level 1 Estrodil (E2) 67.7-113 pg/dL b. Level 2 E2 142-206 pg/dL c. Level 3 E2 312- 418 pg/dL d. Level 1 Human chorionic gonadotropin (HCG) 3.54-5.73 mIU/mL e. Level 2 HCG 20.1-29.0 mIU/mL f. Level 3 HCG 198-268 mIU/mL g. Level 1 Luteinizing Hormone (LH) 1.23-1.97 mIU/mL h. Level 2 LH 17.8-24.2 mIU/mL i. Level 3 LH 61.4-82.7 mIU/mL j Level 1 Progesterone (PROG) .330-.915 ng/mL k. Level 2 PROG 10.0-11.8 ng/mL 2) CV in the COBAS Analyzer was as follows: a. Level 1 E2 71.59-115.79 pg/dL b. Level 2 E2 150.95-220.95 pg/dL c. Level 3 E2 331.9-441.9 pg/dL d. Level 1 HCG 3.6-5.8 mIU/mL e. Level 2 HCG 20.7-29.07 mIU /mL f. Level 3 HCG 181.3-271.3 mIU/mL g. Level 1 LH 1.29-2.097 mIU/mL h. Level 2 LH 18.75-25.75 mIU/mL i. Level 3 LH 65.49-87.49 mIU/mL j Level 1 PROG .476-1.076 ng/mL k. Level 2 PROG 8.84-12.44 ng/mL 3) The TP confirmed on 2/7/23 at 11:30 am the MPI was not followed. -- 2 of 2 --

Summary Statement of Deficiencies D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory records, Sperm Counting Chambers (SCC) and interview with the Technical Supervisor (TS) and Testing Personnel (TP), the laboratory failed to count patient samples in duplicate by not counting two hemocytometer chambers from 11/2/17 to the date of survey. The finding includes: 1. The TP stated at the time of the survey the laboratory performed duplicate counts on semen samples by counting another area of the grid in the same SCC. 2. The TS confirmed on 11/19/19 at 10:45 am that the laboratory did not count patient specimens in duplicate. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Technical Supervisor (TS), the laboratory failed to identify problems on the FR from 11/2/17 to the date of the survey. The finding includes: 1. The "Result" column on the FR did not 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 -- contain the test results but the results were located in a column with out a heading. 2. The TS confirmed on 11/19/19 at 11:30 am the laboratory did not identify problems on the FR. -- 2 of 2 --

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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve a score of at least 80% or more in two out of three events for General Immunology and Endocrinology tests with the College of American Pathologists evaluation. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to achieve a score of 80% for General Immunology tests. The findings include: The laboratory scored a 0% in 3-2018 and 1- 2019 events with the College of American Pathologists as below: a. Alpha Feto Protein b. Immunoglobulin E (IgE) 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to achieve a score of 80% for Endocrinology tests. The findings include: The laboratory scored a 0% in 3-2018 and 1-2019 events with the College of American Pathologists as below: a. Cortisol b. Free thyroxine (free T4) c. Triiodothyronine uptake (T3 uptake) d. Triiodothyronine (T3) e. Total Thyroxine 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --