Shady Grove Fertility Pittsburgh

Summary Statement of Deficiencies D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of the laboratory's Roche Cobas e411 chemistry analyzer verification of performance specifications records and interview with the Office supervisor, the Laboratory Director failed to ensure acceptable levels of analytical performance were established and maintained for chemistry testing performed on the 1 of 1 Roche Cobas e411 analyzer from 1/8/2024 to the date of the survey. Findings Include: 1. The Director of Laboratory Services position description states, "Responsibilities include but are not limited to ensuring operation of equipment by overseeing preventative maintenance requirements and evaluating new equipment and techniques." 2. On the day of the survey, 07/16/2024 at 10:01 am, a review of the laboratory's verification of performance specifications records for the 1 of 1 Roche Cobas e411 (s/n 90D3-21) chemistry analyzer performed on 1/8/2024 revealed the Laboratory Director failed to verify that procedures used established acceptable levels of analytical performance prior to placing the instrument in use. 3. The laboratory could not provide documentation of the Laboratory Director's signature for verification of performance specifications performed on 01/08/2024 to ensure acceptable levels of analytical performance were established and maintained for the Roche Cobas e411 chemistry analyzer prior to use. 4. The Office supervisor confirmed the findings above on 07/16 /2024 at 11:10 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 procedure manuals, review of competency assessment records, and interview with the Technical consultant (TC)#2, the laboratory failed to establish a competency assessment procedure to assess the competency of 4 of 4 Testing Personnel (TP) who perform endocrinology test from 02/19/2020 to the day of survey Findings Include: 1. On the day of survey, 09/13/2022 at 03:23 pm., the laboratory could not provide a written procedure that includes the six points of CLIA to assess the competency of 4 of 4 TP (CMS 209 personnel #2, #3,#4 and #5) for the following endocrinology testing from 02/9/2020 to 09/13/2022. - TSH (Thyroid Stimulating Hormone) - FSH ( Follicle-Stimulating Hormone) - LH (Luteinizing Hormone) - Estradiol (E2), - Progesterone, - HCG (Human Chorionic Gonadotropin), - Prolactin . 2. The TC#2 confirmed the findings above on 09/13/2022 at 05:45 pm. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 review of the College of American Pathologist (CAP) proficiency testing (PT) records and interview with the Technical consultant (TC)#2, the laboratory failed to verify the accuracy for 3 of 3 Prolactin and 2 of 3 Progesterone PT results event A of 2022 . Findings Include: 1. On the day of survey, 09/13/2022 at 03:33 pm, review of 2022 CAP proficiency testing records revealed, the laboratory did not verify the accuracy for the following PT results for CAP Sex hormones Event A 2022: - 3 of 3 Prolactin PT results were not graded by the proficiency testing agency due to non consensus (Y-01, Y-02, Y-03). - 2 of 3 Progesterone PT results were not graded due to outside method/instrument reportable range ( Y-02, Y-03). 2. The TC #2 confirmed the findings above on 09/13/2022 around 05:45 pm. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical consultant (TC)#2, the laboratory failed to verify twice annually the accuracy for Semen Analysis in 2021 and 2022. Findings include: 1. The laboratory's Alternative Proficiency Assessment Methods for Semen Analysis procedure (page 3) under interval states: " Internal PT samples will be shipped two times per year, each sample set should contain two specimens for each test. Each Sample should be evaluated based on test menu (concentration, motility, viability, morphology and DNA fragmentation) in each testing site." 2. On the day of survey, 09/13/2022 at 05:30 pm., The laboratory could not provide documentation of verification of accuracy performed for Semen Analysis ( Motility and Viability) from 01/01/2021 to 09/13/2022. 3. Review of the CMS 116 revealed the laboratory's annual test volume for semen analysis is 107 patient testing. 4. The TC#2 confirmed the findings above on 09/13/2022 at 05:45 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based upon review of hematology records and personnel interview with the Laboratory Coordinator on the date of the survey, the laboratory failed to establish and maintain a maintenance protocol, to ensure accuracy for 2 of 2 pipettes, used for sperm counts for 2 of 2 years. Findings include: 1. At the time of the survey, the laboratory failed to provide documentation of calibration from (02/14/2018 through 02 /19/2020), for the Hamilton 100 ul pipette and the Diamond Pro 100 - 1000 ul pipette. 2. The laboratory failed to provide a maintenance protocol for accuracy of pipettes, on the date of the survey. 3. During the survey (15:00 hours 02/19/2020), the Laboratory Coordinator confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --