Center For Advanced Reproductive Services

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Center for Advanced Reproductive Services Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1998. 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 record review of the 'CASPER Report 155D' from 'Centers for Medicare and Medicaid Services (CMS)' and the proficiency testing evaluation report from the College of American Pathologist (CAP), the laboratory failed to successfully perform proficiency testing (PT) for the regulated analytes: rubella for event 3, 2024 and event 2, 2025 as well as hepatitis B surface antigen for event 2 and 3, 2025. Refer to D2084. 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (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 record review and staff interview, the laboratory failed to achieve satisfactory performance for two out of three consecutive proficiency testing (PT) events for rubella, for event 3, 2024 and event 2, 2025 as well as for hepatitis B surface antigen for event 2 and 3, 2025 in the specialty of diagnostic immunology. Findings include: 1. Record review on 11/10/2025 of the 'CASPER Report 155D' from 'Centers for Medicare and Medicaid Services (CMS)' revealed the laboratory failed to achieve satisfactory scores for the following analytes: a. 'Analyte Number: 0145 - HBS AG' i. '2025, Event 2 - Score: 0*' ii. '2025, Event 3 - Score: 0*' b. 'Analyte Number: 0235 - Rubella' i. '2024, Event 3 - Score: 0*' ii. '2025, Event 2 - Score: 0*' 2. Record review on 11/18/2025 of the College of American Pathologist (CAP) "VM-B 2025 Viral markers (VM1) revealed the following: a. 'Exception Reason Codes appearing in this evaluation: [40] = Results for this kit were not submitted'. b. 'Proficiency: 2025, Event: 2' c. 'Regulated Analyte: HBsAg' d. 'Test Event: VM-B' e. 'Score: 0/5, Percentage: 0%' f. 'Current Event Performance Interpretation: Unsatisfactory' g.

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Center for Advanced Reproductive Services Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 record review of Proficiency Testing (PT) data report (Report 155D) and graded results from College of American Pathologist (CAP), the laboratory failed to obtain a satisfactory score for the regulated analyte Rubella in the subspecialty of General Immunology. The laboratory had unsatisfactory scores for Event 1 of 2023 and Event 2 of 2023. 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 record review and staff interview with the laboratory director (LD), the laboratory failed to achieve a satisfactory score for the analyte #0235 (Rubella) in the subspecialty of General Immunology for 2 consecutive events resulting in unsuccessful performance. Findings include: 1. Record review on 11/22/2023 of the Centers for Medicare and Medicaid Services (CMS) 155D report revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores for 2 consecutive Proficiency Testing (PT) events in 2023 for Analyte #0235: Rubella, specifically Event #1: 0% and Event #2: 0%. 2. Record review on 11/22/2023 of the College of American Pathologist (CAP) 2023 Diagnostic Immunology PT Evaluation forms revealed the following for the regulated analyte, 'Rubella, Qual': a. "Test Method: Rubella Ab, qual, graded results with 'See Note 42'". b. "Legend: "Exception reason codes appearing in this evaluation: 42: No credit assigned due to absence of response". "Test Event Score %" "S-A 2023 0" "S-B 2023 0" c. "Current Event Performance Interpretations: Unsatisfactory". d. "Cumulative CLIA '88 Performance Interpretation: Unsuccessful". 3. Phone interview on 11/09/2023 at 2:45 PM with the LD confirmed the findings in Event 1 of 2023/S-A 2023. The LD further commented he/she was unaware of the recent failure and would investigate Event 2 of 2023/S-B 2023. 4. The laboratory performs 300 Rubella tests annually. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 record review and staff interview with the laboratory director (LD), the laboratory failed to achieve a satisfactory score for the analyte #0065: General Immunology for 2 consecutive events resulting in unsuccessful performance. Findings include: 1. Record review on 11/22/2023 of the Centers for Medicare and Medicaid Services (CMS) 155D report revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores for 2 consecutive Proficiency Testing (PT) events in 2023 for Analyte #0065: General Immunology, specifically Event #1: 50% and Event #2: 0%. 2. Record review on 11/22/2023 of the College of American Pathologist (CAP) 2023 Diagnostic Immunology PT Evaluation forms revealed the following scores for 'General Immunology': a. "Test Event Score %" "S-A 2023 50" "S-B 2023 0" b. "Current Event Performance Interpretation: Unsatisfactory". c. "Cumulative CLIA '88 Performance Interpretation: Unsuccessful". 3. Phone interview on 11/09/2023 at 2:45 PM with the LD confirmed the findings in Event 1/S-A 2023. The LD further commented he/she was unaware of the recent failure and would investigate Event 2 of 2023/S-B 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to follow manufacturer instructions for proper storage of control material in the subspecialty of endocrinology. Findings include: 1. Surveyor observation of the endocrinology laboratory freezer #4 contents on 6/7/18 at 1:45 PM revealed three boxes of Biorad Endocrine Controls. Manufacturer instructions written on these boxes revealed proper storage is -20 to -70C. 2. Record review of the package inserts on 6/7 /18 of the BioRad Endocrine controls stored in freezer #4 revealed proper storage range is -20C to -70C. 3. Record review of the endocrinology laboratory freezer #4 temperature logs on 6/7/18 revealed: a. Acceptable freezer temperature range from May 2017 through December 2017 was less than or equal to -20C. b. Acceptable freezer temperature range from January 2018 through February 2018 is Max less than -17C, Min >-23C c. Digital thermometer was replaced with a new thermometer and calibrated on 2/28/18. d. Acceptable freezer temperature range from March 2018 through May 31, 2018 is Max less than or equal to -15C, Min greater than or equal to -25C. e. Temperatures were out of range on 148 of 396 working days from May 2017 through May 2018, based on manufacturer instructions for control proper storage. The laboratory was unaware because the temperature charts had the incorrect temperature range. 4. Staff interview with the technical supervisor (TS) on 6/7/18 at 1:55PM 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 -- confirmed the manufacturer instructions for the Biorad Endocrine controls are for storage at a lower freezer temperature. TS stated that he/she was unaware of the storage requirements and was not certain if the freezer can attain the temperature range necessary for proper storage. 5. The laboratory performs 45,200 endocrinology tests annually. D5781