Ou Medicine, Inc Reproductive Health

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/23,24/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, general supervisor, patient safety/regulatory manager, medical director, assistant vice president of patient safety/regulatory, director of clinical operations, director of women's services and ambulatory, assistant vice president of laboratory services, and manager of women's services during an exit conference performed at the conclusion of the survey. 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 a review of records, written policies, and interview with the laboratory director and general supervisor, the laboratory failed to follow their written policy to assess the competency of the technical supervisor, based on the position responsibilities listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy titled, "Performance Assessment of Supervisors /Consultants" under section III. "Performance Assessment - Technical Proficiency" stated the performance of general and technical supervisors shall be assessed initially (for individuals new to their CLIA role) and annually to determine whether their performance is satisfactory and if they have a continued understanding of their roles and responsibilities"; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of January 2024 through the current date identified competencies, based on job responsibilities, had not been performed prior to 08/09/2025 for one of one 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 -- individual listed as the technical supervisor; (3) The findings were reviewed with the laboratory director and general supervisor who stated on 09/23/2025 at 11:48 am, the policy had not been followed. 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: Based on a review of records and interview with the laboratory director and general supervisor, the laboratory failed to review and evaluate proficiency testing results for one of four Chemistry proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 09/23/2025/2025, a review of Chemistry proficiency testing records for 2024 (first, second, and third events) and 2025 (first event) identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program) for one of five events: (a) 2025 - CAP Event Y-A (i) Prolactin - five of five results exhibited a positive bias (aa) Sample Y- 01 - SDI of 1.9 (bb) Sample Y-02 - SDI of 2.2 (cc) Sample Y-03 - SDI of 2.1 (dd) Sammple Y-04 - SDI of 2.5 (ee) Sample Y-05 - SDI of 2.4 (ii) Testosterone - five of five results exhibited a positive bias (aa) Sample Y-01 - SDI of 1.4 (bb) Sample Y-02 - SDI of 2.6 (cc) Sample Y-03 - SDI of 5.2 (dd) Sample Y-04 - SDI of 2.3 (ee) Sample Y-05 - SDI of 3.0 (2) There was no evidence in the records to prove the biases had been identified and addressed; (3) The records were reviewed with the laboratory director and general supervisor who stated on 09/23/2025 at 01:40 pm, the biases had not been identified and addressed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 a review of written policies and procedures, record review, and interview with the laboratory director and general supervisor, the laboratory failed to follow written procedures, that explained the current practices and procedures being performed in the laboratory for immunoassay quality control for five of five months reviewed. Findings include: (1) On 90/24/2025 at 09:00 am, the general supervisor stated that laboratory performed immunoassay testing using the Beckman Coulter Access II for the following analytes, Estradiol, Progesterone, Human Chorionic Gonadotropin, Luteinizing Hormone, Thyroid Stimulating Hormone, Follicle Stimulating Hormone, Prolactin, Testosterone, High Sensitivity Estradiol, and Anti- Mullerian Hormone; (2) A review of the laboratory's written policy, titled, "Quality Management Program" revealed the following: (a) "Three levels of controls are run on a daily basis, since the laboratory only operates on one eight hour shift per day. Westgard rules will be applied to the collected data to decrease the subjectivity of data analysis and flag results when rules are broken. When controls are out of range, -- 2 of 4 -- controls will be re-run and recalibrated as necessary;" (b) A review of the Accuracy and Precision Flags portion of the Quality Management Policy defines a Westgard 2- 2s failure as follows, "Results between 2SD (standard deviation) and 3SD as compared to the previous result. If two consecutive results are greater than 2SD on the same side of the assigned mean, the system:-flags the result as two consecutive controls >2SD (Accuracy) on the QC log report." (3) A review of QC (quality control) and calibration logs from 05/01/2025 through 08/31/2025 identified the following: (a) Estradiol - 2-2s QC failures on 05/04/2025, 05/14/2025, 05/15/2025, 05/16/2025, 05 /20/2025, and 05/21/2025 where no

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/16/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, administrative director for regulatory complicance, and technical supervisor #2 at the conclusion of the survey. 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 a review of records and interview with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director and/or testing person(s) for eight of nine events reviewed in 2023. Findings include: (1) A review of 2023 AAB-MLE (American Association of Bioanalysts Medical Laboratory Evaluation) and CAP (College of American Pathologists) proficiency testing records identified the following for eight nine events: (a) AAB-MLE S1 2023 (i) The attestation statement had not been signed by the testing person(s). (b) Y-A 2023 Sex Hormones (i) The attestation statement had 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 5 -- been signed by the testing person(s). (c) K-A 2023 Ligand-General (i) The attestation statement had not been signed by the testing person(s). (d) AMH-A 2023 Antimullerian Hormone (i) The attestation statement had not been signed by the testing person(s). (e) Y-B 2023 Sex Hormones (i) The attestation statement had not been signed by the laboratory director and testing person(s). (f) K-B Ligand-General (i) The attestation statement had not been signed by the laboratory director and testing person(s). (g) AMH-B 2023 Antimullerian Hormone (i) The attestation statement had not been signed by the laboratory director and testing person(s). (h) K-C 2023 Ligand- General (i) The attestation statement had not been signed by the laboratory director and testing person(s). (2) The findings were reviewed with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2. All stated on 01/16/2024 at 11:30 am, the attestation statements had not been signed as stated above. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and technical supervisor #2, the laboratory failed to retain quality control records for at least two years for nine of 12 months reviewed from January through December 2023. Findings include: (1) On 01/16/2024 at 09:40 am, technical supervisor #2 stated the following: (a) AMH (Anti-Mullerian Hormone), Estradiol, FSH (Follicle Stimulating Hormone), HCG (Human Chorionic Gonadotropin), DHEA-S (Dehydroepiandosterone Sulfate), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone, and TSH (Thyroid Stimulating Hormone) testing were performed on the Beckman Coulter Access 2 analyzer; (b) Three levels (Low, Normal, and High) of Bio-Rad Liquichek AMH Control materials were performed each day of patient AMH testing and three levels (Low, Normal, and High) of Bio- Rad Liquichek Immunoassay Plus Controls were performed each day of patient testing for the remaining analytes. (2) A review of QC (Quality Control) and Levey Jennings records from January through December 2023 identified no evidence that Levey-Jennings graphs and cumulative QC data had been reviewed for nine of 12 months (January through September 2023); (3) Interview with the laboratory director and technical supervisor #2 on 01/16/2024 at 02:00 pm confirmed the following: (a) Levey-Jennings graphs were routinely reviewed and maintained in the analyzer's memory; (b) Due to a hard drive failure, the data had been destroyed prior to October 2023 and was not available for review. 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: -- 2 of 5 -- Based on a review of records, written policies and procedures, and interview with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2, the laboratory failed to have a written policy to assess the competency of the general supervisors and technical supervisor, based on the position responsibilities as listed in Subpart M, for six of six persons serving as general supervisor and one of two persons serving as technical supervisor. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the general supervisors and technical supervisor including the frequency of the assessments; (2) A review of the Form CMS- 209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of February 2022 through the current date identified competencies, based on job responsibilities, had not been performed for six of six persons listed as general supervisor and one of two persons listed as technical supervisor on Form CMS-209; (3) The findings were reviewed with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2. All stated on 01/16/2024 at 12:10 pm, a policy had not been written and competencies had not been performed for the general supervisors and technical supervisor. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory director and technical supervisor #2, the laboratory failed to follow the manufacturer's instructions for storing patient specimens prior to AMH (Anti-Mullerian Hormone), DHEA-S (Dehydroepiandosterone Sulfate), FSH (Follicle Stimulating Hormone), Prolactin, and Testosterone testing for five of five patient specimens. Findings include: (1) On 01/16/2024 at 09:40 am, technical supervisor #2 stated the following: (a) AMH, DHEA-S, FSH, Prolactin, and Testosterone testing were performed using the Beckman Coulter Access 2 analyzer; (b) Testing for the above analytes was performed each Thursday and aliquoted serum samples were stored in the white LG freezer (denoted by the laboratory as "Endo Freezer 2 (White)). (2) A review of the manufacturer's product inserts for the above analytes identified the following storage requirements under "Specimen Collection and Preparation" for each analyte: (a) For AMH it stated, "If the assay will not be completed within 6 days, or for shipment of samples beyond 6 days, freeze at -20 C or colder"; (b) For DHEA-S, FSH, Prolactin, and Testosterone it stated, "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 C or colder". (4) Observation of the White LG freezer on 01/16/2024 at 02:45 pm identified the following patient specimens that had been collected from 01/12/2024 through 01/15/2024 awaiting testing: (a) Patient specimen #1 collected on 01/12/2024 for AMH testing; (b) Patient specimen #2 collected on 01/15/2024 for AMH testing; (c) Patient specimen #3 collected on 01/15/2024 for FSH and Testosterone testing; (d) Patient specimen #4 collected on 01/15/2024 for DHEA-S, Prolactin, and Testosterone testing; (e) Patient -- 3 of 5 -- specimen #5 collected on 01/15/2024 for AMH testing. (5) A review of temperature records for January 2024 identified the specimens had been stored at temperatures warmer than -20 degrees C (Centigrade) for five of five days for patient specimen #1 and two of two days for patient specimen #2, patient specimen #3, patient specimen #4, and patient specimen #5 as follows: (a) 01/12/2024 - The documented temperature was -18 degrees C (b) 01/13/2024 - The documented temperature was -19 degrees C (c) 01/14/2024 - The documented temperature was -18 degrees C (d) 01/15/2024 - The documented temperature was -18 degrees C (e) 01/16/2024 - The documented temperature was -17 degrees C (6) The findings were reviewed with the laboratory director and technical supervisor #2. Both stated on 01/16/2024 at 02:55 pm, the patient specimens had not been stored as required by the manufacturer. 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 a review of records, manufacturer's instructions, observation, and interview with the laboratory director and technical supervisor #2, the laboratory failed to ensure control and calibration materials were stored as required for four of six months during the review period of July 2023 through December 2023 Findings include: (1) On 01/16/2024 at 09:50 am, observation of the contents of the black Frigidaire freezer (a frost-free freezer which was denoted by the laboratory as "Endocrinology Freezer #2), identified the following: (a) Bio-Rad Liquichek Immunoassay Plus Controls - Two boxes of two bottles each of level 1 lot #85331, level 2 lot #85332, and level 3 lot #85333; the storage requirement was -70 to -20 degrees C (Centigrade); (b) Bio- Rad Liquichek AMH Controls - Two boxes of two bottles each of level 1 lot #1001901, level 2 lot #1001902, and level 3 lot #1001903; the storage requirement was -70 to -20 degrees C. In addition, the instructions contained in the package insert stated, "For optimum performance, avoid storing this product in a frost-free freezer"; (c) Access Prolactin Calibrators - Two boxes of lot number 338243; the storage requirement was -20 degrees C and colder; (d) Access Progesterone Calibrators - One box of lot number 338610; the storage requirement was -20 degrees C and colder. (2) A review of temperature records from July 2023 through December 2023 identified documented temperatures were warmer than -20 degrees C (the warmest requirement for the materials above) for four of six months as follows: (a) August 2023 - The documented temperatures were warmer than -20 degrees C for one of 31 days (08/22 /2023); (b) September 2023 - The documented temperatures were warmer than -20 degrees C for three of 30 days (09/17,18,26/2023); (c) October 2023 - The documented temperatures were warmer than -20 degrees C for three of 31 days (10/14, 15,24/2023); (d) December 2023 - The documented temperatures were warmer then -20 degrees C for two of 28 days (12/02,28/2023). (3) The records were reviewed with the laboratory director and technical supervisor #2. Both stated on 01/16/2024 at 12: 45 pm, the materials were not being stored as required by the manufacturer. -- 4 of 5 -- 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 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 a review of records and interview with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2, the laboratory failed to ensure patient test reports included the name, as stated on the CLIA certificate, and address of the laboratory location where the testing was performed for two of two reports reviewed. Findings include: (1) A review of the following two patient reports identified the laboratory name was listed as "OUHP AELAB-Reproductive Medicine" (the name on the CLIA certificate was "OU Medicine, Inc. Reproductive Health") and the laboratory address was not included: (a) Patient Semen Analysis testing resulted on 01/16/2024; (b) Estradiol, HCG (Human Chorionic Gonadotropin), and Progesterone testing resulted on 01/16/2024. (2) The findings were reviewed with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2. All stated on 01/16/2024 at 01:15 pm, the laboratory name, as stated on the CLIA certificate, and address had not been included on the patient test reports. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2, the laboratory failed to provide normal reference intervals for one of one patient test report. Findings include: (1) On 01/16/2024 at 09:40 am, technical supervisor #2 stated Estradiol, HCG (Human Chorionic Gonadotropin), and Progesterone testing were performed on the Beckman Coulter Access 2 analyzer; (2) A review of one patient test report for testing performed for the above analytes on 01/16/2024 identified normal reference ranges were not included for each analyte; (3) The report was reviewed with the laboratory director, administrative director for regulatory compliance, and technical supervisor #2. All stated on 01/16/2024 at 01:15 pm the patient report did not include normal reference ranges. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/31/2022. The findings were reviewed with the laboratory director, technical supervisor #2, and the general supervisor during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure that proficiency testing samples were tested by personnel who routinely performed patient testing for seven of seven Proficiency Testing events. Findings include: (1) On 01/31/2022 at 10:00 am, the technical supervisor #2 stated the following to surveyor #1: (a) HCG (Human Chorionic Gonadotropin), TSH (Thyroid Stimulating Hormone), DHEA (Dehydroepiandrosterone), Estradiol, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone, and AMH (Antimullerian Hormone) testing were performed using the Beckman Coulter Access 2 analyzer; (2) Surveyor #2 reviewed the Laboratory Personnel Report (Form CMS-209), that had been completed by the laboratory director prior to the survey. The laboratory director stated that five persons performed the above patient testing in the laboratory (technical supervisor #2/testing person #1, General Supervisor/testing person #2, testing person #3, testing person #4, and testing person #5); (3) Surveyor #2 then reviewed 2021 proficiency testing records and identified that seven of seven events had been tested by the same person (technical supervisor/testing person #1); (4) The findings were reviewed with the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- director. The laboratory director stated on 01/31/2022 at 12:20 pm, the proficiency testing samples had been tested by technical supervisor/testing person #1, as indicated above. 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 a review of records, written policy, and interview with the laboratory director, the laboratory failed to have a written general supervisor competency policy based on the position responsibilities as listed in Subpart M for one of one technical consultant. Findings include: (1) On 01/31/2022, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the general supervisor; (2) The surveyor then reviewed personnel records for competency assessments performed during 2020, and 2021. There was no evidence of competencies performed for the general supervisor based on their job responsibilities; (3) The surveyor asked the laboratory director if a written policy to evaluate the general supervisor based on job responsibilities was available. The laboratory director stated on 01/31/2022 at 12:00 pm a policy had not been written and the above competency had not been performed. 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 a review of records, manufacturer's instructions, observation, and interview with the laboratory director and technical supervisor #2, the laboratory failed to ensure control and calibration materials were stored as required; and failed to ensure the humidity of the laboratory was monitored. Findings include: STORAGE OF CONTROL MATERIALS (1) On 01/31/2022 at 10:00 am, surveyor #1 observed the contents of the black Frigidaire freezer in the laboratory (denoted by the laboratory as "Endocrinology Freezer #2), which was a frost-free freezer. The following control materials were being stored in the freezer, with the manufacturer's storage requirements as stated in the package insert: (a) Bio-Rad Liquichek AMH controls - 1 box of 2 bottles each of level 1 lot #48541, level 2 lot #48542, and level 3 lot #48543; the storage requirement was -20 to -70 degrees C (Centrigrade). In addition, the instructions contained in the package insert stated, "For optimum performance, avoid storing this product in a frost-free freezer"; (2) On 01/31/2022 at 10:10 am, the laboratory director and technical supervisor #2 stated to surveyor #1 the Bio-Rad -- 2 of 6 -- Liquichek AMH controls were used to perform quality control procedures for AMH (Anti-Mullerian Hormone) testing performed on the Beckman Coulter Access 2 analyzer; (3) Surveyor #1 reviewed the manufacturer's instructions with the laboratory director and technical supervisor #2, and explained that the controls were not being stored as required by the manufacturer since they were being stored in a frost-free freezer; (4) The laboratory director and technical supervisor #2 stated to surveyor #1 on 01/31/2022 at 12:00 pm, the controls were not being stored as stated by the manufacturer. STORAGE OF CALIBRATION MATERIALS (1) On 01/31/2022 at 10:20 am, surveyor #1 observed the contents of the white LG freezer, (denoted by the laboratory as Endocrinology Freezer #1), which was a frost-free freezer. the following calibration materials were being stored in the freezer, along with the manufacturer's storage requirements: (a) 1 box of Access Prog Cal, lot #124774; the storage requirement was -20 degrees C and colder; (b) 1 box of Access Prol Cal, lot #124307; the storage requirement was -20 degrees C and colder; (c) 1 box of Access hLH Cal, lot #124361; the storage requirement was -20 degrees C and colder. (2) On 01/31 /2022 at 10:30 am, the laboratory director and technical supervisor #2 stated the following to surveyor #1: (a) The refrigerator was new to the laboratory and had been put into use on 01/24/2022; (b) The calibration materials were used for testing performed on the Beckman Coulter Access 2 analyzer as follows: (i) Access Prog Cal was used to perform calibration procedures for Progesterone testing; (ii) Access Prol Cal was used to perform calibration procedures for Prolactin testing; (iii) Access hLH Cal was used to perform calibration procedures for Luteinizing Hormone testing. (3) Surveyor #1 reviewed temperature records for the freezer from 01/24/2022 through 01 /31/2022. The documented temperatures were warmer than -20 C (the warmest temperature allowed for the materials) for 2 of 8 days as follows: (a) 01/24/2022 - The documented temperature was -19 C (b) 01/29/2022 - The documented temperature was -19 C (4) Surveyor #1 reviewed the records with the laboratory director and technical supervisor #2. Both stated on 01/31/2022 at 12:05 pm, the freezer temperatures were unacceptable as shown above. HUMIDITY (1) On 01/31/2022 at 10:00 am, the laboratory director and technical supervisor #2 stated to surveyor #1 the laboratory began using the Beckman Coulter Access 2 analyzer to perform HCG (Human Chorionic Gonadotropin), TSH (Thyroid Stimulating Hormone), DHEA (Dehydroepiandrosterone), Estradiol, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone, and AMH (Antimullerian Hormone) on 04/17/2020; (2) Surveyor #1 reviewed the manufacturer's humidity requirements for the analyzer. The manufacturer required the humidity be maintained at 20-80%; (3) Surveyor #1 asked the laboratory director and technical supervisor #2 if the humidity of the laboratory had been monitored since the analyzer had been put into use. The laboratory director and technical supervisor #2 stated on 01/31/2022 at 02:20 pm the humidity of the laboratory had not been monitored. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and technical supervisor #2, the laboratory failed to ensure the verification data had been evaluated prior to implementing a new analyzer for 1 of 1 new test systems. Findings include: (1) On 01/31/2022 at 10:00 am, the laboratory director and technical supervisor #2 stated to surveyor #1 the laboratory began using the Beckman Coulter Access 2 analyzer to perform HCG (Human Chorionic Gonadotropin), TSH (Thyroid Stimulating Hormone), DHEA (Dehydroepiandrosterone), Estradiol, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone, and AMH (Antimullerian Hormone) on 04/17/2020; (2) Surveyor #1 reviewed the performance specification records for the new test system and identified that, although the laboratory demonstrated the performance specifications for the test system, there was no evidence the data had been reviewed and evaluated by the laboratory as acceptable; (3) Surveyor #1 reviewed the records with the laboratory director and asked if the laboratory had reviewed and evaluated the data prior to putting the test system into use for patient testing. The laboratory director stated to surveyor #1 on 01/31/2022 at 12:55 pm that, although the laboratory director had reviewed and approved the data prior to beginning patient testing, it had not been documented. (NOTE: The interpretive guidelines at 493.1253(b)(1) state, "The laboratory is responsible for verifying the performance specifications of each nonwaived unmodified FDA-cleared or approved test system that it introduces, prior to reporting patient test results." In addition, the interpretive guidelines state, "Prior to introducing a test for routine patient testing, the laboratory must review and evaluate the verification data.") D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory director, technical supervisor #2, and the general supervisor, the laboratory failed to follow the manufacturer's instructions for performing weekly maintenance procedures for the Beckman Coulter Access 2 analyzer. Findings include: On 01/31 /2022 at 10:00 am, the laboratory director and technical supervisor #2 stated to surveyor #1 the laboratory began using the Beckman Coulter Access 2 analyzer to perform HCG (Human Chorionic Gonadotropin), TSH (Thyroid Stimulating Hormone), DHEA (Dehydroepiandrosterone), Estradiol, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone, and AMH (Antimullerian Hormone) on 04/17/2020; (2) Surveyor #1 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log. The weekly requirements were as follows: (a) Clean Instrument Exterior (b) Inspect Liquid Waste Bottle (c) Check Waste Filter Bottle (d) Inspect/Clean Primary Probe (e) Replace/Clean Aspirate Probes (f) Run System Check (3) Surveyor #1 then reviewed maintenance records from January 2021 through January 2022. The weekly maintenance had not been documented as performed between: (a) 04/15/2021 and 04 /26/2021 (b) 06/10/2021 and 06/22/2021 (c) 07/07/2021 and 07/19/2021 (d) 07/19 /2021 and 08/05/2021 (e) 12/23/2021 and 01/07/2022 (4) Surveyor #1 reviewed the -- 4 of 6 -- findings with the laboratory director, technical supervisor #2, and general supervisor. All stated on 01/31/2022 at 03:00 pm the weekly maintenance had not been documented as performed as identified above. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory director failed to ensure that a person performing moderate complexity testing had the appropriate training. Findings include: (1) On 01/31/2022, surveyor #2 reviewed personnel records. The following was identified: (a) Testing Person #3 - This person was hired to perform patient testing on 01/11/2021. There was no documentation this person had been initially trained. A competency evaluation had not been documented as performed until 06/21/2021; (b) Testing #5 - This person was hired to perform patient testing on 11/08/2021. There was no documentation this person had been initially trained. A competency evaluation had not been documented as performed until 12/20/2021; (2) Surveyor #2 reviewed the findings with the laboratory director, who stated on 01/31/2021 at 11:50 am, there was no additional documentation to prove the above person had been initially trained to perform moderate complexity testing. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory director failed to ensure that a person performing high complexity testing had the appropriate training. Findings include: (1) On 01/31/2022, surveyor #2 reviewed personnel records. The following was identified: (a) Testing Person #3 - This person was hired to perform patient testing on 01/11/2021. There was no documentation this person had been initially trained. A competency evaluation had not been documented as performed until 06/21/2021; (b) Testing #5 - This person was hired to perform patient testing on 11/08/2021. There was no documentation this person had been initially trained. A competency evaluation had not been documented as performed until 12/20/2021; (2) Surveyor #2 reviewed the findings with the laboratory director, -- 5 of 6 -- who stated on 01/31/2021 at 11:50 am, there was no additional documentation to prove the above person had been initially trained to perform high complexity testing. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/09/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and technical supervisor#2/technical consultant #2 at the conclusion of the survey. 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 a review of records and interview with the laboratory direcor and technical supervisor#2/technical consultant #2, the laboratory director (or designee) and/or testing person(s) failed to sign proficiency testing attestation statements. Findings include: (1) During the survey, surveyor #1 reviewed 2018 and 2019 proficiency testing records and identified the following for 8 of 13 events: (a) First 2018 Embryology/Andrology Event (S1) - The attestation statement had not been signed by the laboratory director or designee; (b) First 2018 Ligand General Event (K-A) - The attestation statement had not been signed by the laboratory director or designee and the testing person(s); (c) Second 2018 Embryology/Andrology Event (S2) - The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- attestation statement had not been signed by the laboratory director or designee and the testing person(s); (d) Second 2018 Ligand Special (Y-B) - The attestation statement had not been signed by the laboratory director or designee and the testing person(s); (e) Third 2018 Ligand General Event (K-C) - The attestation statement had not been signed by the laboratory director or designee and the testing person(s); (f) First 2019 Embryology/Andrology Event (S1) - The attestation statement had not been signed by the laboratory director or designee and the testing person(s); (g) Second 2019 Embryology/Andrology Event (S2) - The attestation statement had not been signed by the laboratory director or designee and the testing person(s); (h) Second 2019 Ligand Special (Y-B) - The attestation statement had not been signed by the laboratory director or designee and the testing person(s). (2) Surveyor #1 reviewed the findings with the laboratory director and technical supervisor#2/technical consultant #2. Both stated the attestation statements had not been signed as indicated above. 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 a review of records and interview with the laboratory director, the laboratory failed to have a written competency policy for the clinical consultant, technical consultant, technical supervisor, and general supervisor based on the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, surveyor #1 reviewed personnel records for competency assessments performed during 2018 and to date in 2019. There was no evidence competencies had been performed for the clinical consultant, technical consultant #2, technical supervisor #2, and general supervisor, based on their job responsibilities; (2) Surveyor #1 asked the laboratory director if a written policy to evaluate the positions based on job responsibilities was available and if competencies had been performed during the review period. The laboratory director stated a policy to evaluate the clinical consultant, technical consultant #2, technical supervisor #2, and general supervisor, based on job responsibilities had not been written; and competencies had not been performed. 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 a review of the policy and procedure manual and interview with the laboratory director and technical supervisor #2/technical consultant #2 the laboratory failed to follow written procedures for complete semen analysis testing in the laboratory. Findings include: (1) At the beginning of the survey, the laboratory -- 2 of 6 -- director stated that the laboratory performed a complete semen analysis. (2) Later during the survey, the surveyors reviewed the procedure titled, "Protocol # 1.1 Complete Semen Analysis" which stated: (a) Insure that the specimen is evaluated within 90 minutes of collection, with a goal of 60 minutes". (2) Surveyor #2 reviewed patient records from 10/01/19 through 12/02/19 and identified 109 of 184 patients did not meet the laboratory's goal of 60 minutes and 72 of 184 patients did not meet the allowable time limit of 90 minutes. 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. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, policies and procedures and interview with the laboratory director, the laboratory failed to follow the manufacturer's instructions for obtaining a second sperm count reading. Findings include: (1) At the beginning of the survey, the laboratory director stated to the surveyors that the laboratory used the Leja slides to perform a sperm count reading. (2) Later during the survey, surveyor #2 reviewed the manufacturer's instructions for obtaining a sperm count reading which stated: (a) "Count at least six different fields and 800-1000 cells for accuracy"; (b) "Repeat the process on a different chamber loaded with the same sample to get a second reading". (3) Surveyor #2 reviewed the written policies and procedures. The procedure titled, "Protocol #1.1 - Complete Semen Analysis" did not include instructions for obtaining a second sperm count reading as stated in the manufacturer's instructions for the Leja slides; (4) Surveyor #2 then reviewed records and identified a patient semen analysis performed on 11/01/19. The records did not include documentation that a second sperm count reading had been performed; (5) Surveyor #2 reviewed the records with the laboratory director and technical supervisor #2/technical consultant #2 who stated a second sperm count reading was not routinely performed. 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 a review of records, manufacturer's storage instructions, observation of the laboratory freezer and interview with the laboratory director and technical supervisor #2/technical consultant #2, the laboratory failed to ensure materials were being stored as required. Findings include: SANYO ULTRA LOW FREEZER (1) At the beginning -- 3 of 6 -- of the survey, the surveyors observed the contents of the Sanyo Ultra Low freezer in the laboratory. The following were examples of materials being stored in the freezer, along with the manufacturer's storage requirements: (a) 3 boxes of BioRad Liquichek Immunoassay Plus Control materials (Level 1 lot #40991, Level 2 lot# 40992, Level 3 lot#40993); the storage requirement was -70 to -20 degrees Centigrade (C). (2) The surveyors asked the laboratory director and technical supervisor #2/technical consultant #2 to explain what the materials were used for. The laboratory director and technical supervisor #2/technical consultant #2 stated the following: (a) The BioRad Liquichek Immunoassay Plus Control materials were used to perform quality control for endocrinology testing performed on the Immulite 1000 analyzer. (3) The surveyors then reviewed temperature records for 10 months (January 2019 through October 2019). It was identified that documented temperatures were colder than -70 degrees C (the coldest temperature allowed for the materials) for 10 of 10 months reviewed as follows: (a) January 2019 - 31 of 31 temperatures were documented as -80 degrees C or colder; (b) February 2019 - 28 of 28 temperatures were documented as -79 degrees C or colder; (c) March 2019 - 31 of 31 temperatures were documented as -78 degrees C or colder; (d) April 2019 - 30 of 30 temperatures were documented as -79 degrees C or colder; (e) May 2019 - 31 of 31 temperatures were documented as -80 degrees C or colder; (f) June 2019 - 30 of 30 temperatures were documented as -79 degrees C or colder; (g) July 2019 - 31 of 31 temperatures were documented as -80 degrees C or colder; (h) August 2019 - 31 of 31 temperatures were documented as -80 degrees C or colder; (i) September 2019 - 30 of 30 temperatures were documented as -79 degrees C or colder; (j) October 2019 - 31 of 31 temperatures were documented as -79 degrees C or colder; (4) The surveyors reviewed the records with the laboratory director and technical supervisor #2/technical consultant #2 who stated the materials had not been stored according to manufacturer's instruction. ENDOCRINOLOGY FRIGIDAIRE FREEZER (1) At the beginning of the survey, the surveyors observed the contents of the Endocrinology Frididaire freezer in the laboratory. The following were examples of materials being stored in the freezer, along with the manufacturer's storage requirements: (a) 3 boxes (9 bottles) of BioRad Liquichek Immunoassay Plus Control materials (Level 1 lot #40991, Level 2 lot# 40992, Level 3 lot#40993); the storage requirement was -70 to -20 degrees Centigrade (C); (b) 1 box of Siemens Immulite Systems Follicle-Stimulating Hormone Calibration Verification materials (lot# 0105); the storage requirement was -20 degrees C and colder; (c) 1 box of Siemens Immulite Systems Luteinzing Hormone Calibration Verification materials (lot# 0103); the storage requirement was -20 degrees C and colder; (d) 1 box of Siemens Immulite Systems Thyroid Stimulating Hormone Calibration Verification materials (lot# 0107); the storage requirement was -20 degrees C and colder; (2) The surveyors asked the laboratory director and technical technical supervisor #2/technical consultant #2 to explain what the materials were used for. The laboratory director and technical supervisor #2/technical consultant #2 stated the following: (a) The BioRad Liquichek Immunoassay Plus Control materials were used to perform quality control for endocrinology testing performed on the Immulite 1000 analyzer; (b) The Siemens Immulite Systems Follicle-Stimulating Hormone Calibration Verification materials were used to perform calibration; (c) The Siemens Immulite Systems Luteinzing Hormone Calibration Verification materials were used to perform calibration; (d) The Siemens Immulite Systems Thyroid Stimulating Hormone Calibration Verification were used to perform calibration. (3) The surveyors then reviewed temperature records for 10 months (January 2019 through October 2019). It was identified that documented temperatures were warmer than -20 degrees C (the warmest temperature allowed for the materials) for 10 of 10 months reviewed as follows: (a) January 2019 - 6 of 31 temperatures were documented as -19 degrees C (Days 7,9,12,15,23,25); (b) February 2019 - 6 of 28 temperatures were documented as -19 degrees C (Days -- 4 of 6 -- 3,5,7,11,14,23); (c) March 2019 - 4 of 31 temperatures were documented as -19 degrees C (Days 13,22,27,31); (d) April 2019 - 7 of 30 temperatures were documented as -19 degrees C (Days 3,6,9,14,18,20,22); (e) May 2019 - 3 of 31 temperatures were documented as -19 degrees C (Days 9,10,11); (f) June 2019 - 2 of 30 temperatures were documented as -19 degrees C (Days 10,16); (g) August 2019 - 1 of 31 temperatures were documented as -19 degrees C (Day 20); (i) September 2019 - 1 of 30 temperatures were documented as -19 degrees C (Day 28); (j) October 2019 - 9 of 31 temperatures were documented as -19 degrees C (Days 2,9,12,23,26,27,28,29,31); (4) The surveyors reviewed the records with the laboratory director and technical supervisor #2/technical consultant #2 who stated the materials had not been stored according to manufacturer's instruction. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory director and technical supervisor #2/ technical consultant #2, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) At the beginning of the survey, the laboratory director stated endocrinology testing was performed on the Immulite 1000 analyzer; (2) Later during the survey, surveyor #2 reviewed the manufacturer's maintenance requirements as stated on page 8-19 of the operator's manual. The requirements for semi- annual maintenance were as follows: (a) Replace the In-Line Filter Tubing (b) Changing the Large Syringe Tip (3) Surveyor #2 then reviewed maintenance records for 10 months (January 2019 through October 2019). The was no evidence the semi- annual maintenance had been performed. (4) The surveyor reviewed the records with the laboratory director and technical supervisor #2/technical consultant #2, who stated the semi-annual maintenance had not been performed as required. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical supervisor#2/technical consultant #2, the laboratory failed to have control procedures that monitored the -- 5 of 6 -- accuracy and precision of the testing process. Findings include: (1) At the beginning of the survey, the technical supervisor#2/technical consultant #2, stated the following to the surveyors: (a) DHEA-S (Dehydroepiandrosterone-sulfate), Estradiol, HCG (Human Chorionic Gonadotropin), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone, and TSH (Thyroid Stimulating Hormone) testing were performed using the Beckman Coulter Access 2 analyzer; (b) Three levels of Bio-Rad Liquichek Immunoassay Plus control materials were tested each day that patient testing was performed (the laboratory generally performed the testing on a weekly basis); (c) The laboratory established their own means and ranges before new lot numbers of quality control materials were put into use. (2) Later during the survey, surveyor #1 reviewed quality control records for 6 lot numbers of control materials used during the review period of January 2019 through the day of the survey. For 6 of 6 lot numbers, there were no records (i.e., Levey- Jennings data) proving the control results had been monitored for variances (although the laboratory participated in the Bio-Rad Unity Peer Program, the control results were evaluated against peer data instead of the laboratory established ranges). The QC lot numbers were as follows: (a) Level 1 lot #40951, level 2 lot #40952, and level 3 lot #40953 - In use from 01/01/19 through 08/31/19; (b) Level 1 lot #40991, level 2 lot #40992, and level 3 lot #40993 - Put into use on 09/16/19 and currently in use the day of the survey. (3) Surveyor #1 asked the technical supervisor#2/technical consultant #2 if the lot numbers above had been monitored for variances using the laboratory established ranges. Technical supervisor#2/technical consultant #2 stated to surveyor #1 the controls had not been monitored for variances. -- 6 of 6 --

Summary Statement of Deficiencies D0000 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 --