Fertility Institute Of New Orleans, Apc

Summary Statement of Deficiencies D0000 A desk review was performed on April 07, 2025 at Fertility Institute of New Orleans, CLIA ID #19D1064020. The following condition level deficiencies were identified: 493.803: Successful Participation 493.1403: Laboratory Director, Moderate Complexity 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 proficiency testing results from the CMS-153D, CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for Endocrinology for two consecutive events, resulting in an initial unsuccessful performance. Refer to D2108. 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 -- 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 a review of the CASPER 153D & 155D Report and American Proficiency Institute (API) proficiency testing results, the laboratory failed to achieve satisfactory overall score in Endocrinology for two consecutive events, resulting in initial unsuccessful performance. Findings: 1. Review of CASPER 153D & 155D report and proficiency testing results from API revealed the laboratory received an overall score of less than 0% for the following two consecutive events for Endocrinology: a. Event 3 of 2024 received a score of 0% b. Event 1 of 2025 received a score of 0% 2. Further review of PT records revealed the laboratory enrolled in the following Endocrinology analytes: human chorionic gonadotropin (HCG) and thyriod stimulating hormone (TSH). 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction. 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 record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to achieve satisfactory overall score in Endocrinology for two consecutive events, resulting in initial unsuccessful performance. Refer to D2108 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Fertility Institute of New Orleans, CLIA ID 19D1064020 on March 20, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and proficiency testing (PT) records as well as interview with personnel, the laboratory failed to maintain a complete policy for proficiency testing. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include instructions for review and documentation of PT evaluation results that are ungraded. 2. Review of the laboratory's American Proficiency Institute (API) PT records revealed the following events had ungraded results that were not reviewed by the laboratory: a) 2022 Hematology/Coagulation - 3rd event b) 2023 Hematology/Coagulation - 1st event c) 2023 Hematology/Coagulation - 3rd event 3. In interview on March 20, 2024 at 11:50 a.m., the Technical Supervisor confirmed the laboratory did not include review of ungraded proficiency testing results. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are 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 -- established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that a quality assessment (QA) program was maintained to assure the quality of laboratory services provided. Refer to D5291. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 26, 2022 at Fertility Institute of New Orleans, CLIA ID # 19D1064020. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of laboratory policy and procedure, quality control records, patient test reports and interview with personnel, the laboratory failed to perform and document quality control (QC) for each day of patient testing for manual sperm counts. Findings: 1. Review of the laboratory's policy for "Performing Daily QC for Sperm Counting" revealed "Perform QC on any day that sperm counting is performed" along with the following steps: a. Vortex Low and High level Accubeads to insure a uniform suspension b. With the micropipetter, pipette 2.5 uL of Low Level beads into the first chamber on the Cell Vision slide. Repeat with the High Level Accubeads in the second chamber. c. Allow the beads to settle for 5 minutes d. Count beads in two separate areas in each Cell Vision chamber for Low and High level beads, along the midline e. Record average results of replicate counts for each bead level on the Accubead QC chart 2. Review of the laboratory's quality control (QC) and patient test records during July 2021, December 2021 and March 2022 revealed the laboratory did not perform or document two (2) levels of QC for the following one (1) of six (6) patients reviewed: a) Patient 10497: Reported March 11, 2022 at 12:15 pm 3. In interview on May 26, 2022 at 4:40 pm, Personnel 3 stated she possibly 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 -- documented the QC on March 10, 2022 instead of March 11, 2022 but has no documentation to support. Personnel 3 confirmed that QC was not documented for the above identified patient. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, quality control and patient test records as well as interview with personnel, the Laboratory Director failed to ensure that a quality control program was established to assure the quality of laboratory testing. Refer to D5543. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, quality control records and patient test reports as well as interview with personnel, the Technical Supervisor failed to ensure that a quality control program was maintained to assure the quality of manual sperm counting. Refer to D5543. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification survey was performed at Fertility Institute of New Orleans-Baton Rouge, CLIA ID 19D1064020 on February 6, 2020. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on record review and interview with personnel, the laboratory failed to have a complete competency assessment policy. Findings: 1. Review of the laboratory's "Laboratory Personnel Competency" policy revealed "Each new employee will be assessed initially and then annually on all procedures for which they will be responsible." 2. Further review of the "Laboratory Personnel Competency" policy revealed the laboratory's policy did not include a semi-annual assessment during the first year of hire. 3. In interview on February 6, 2020 at 2:38 pm , General Supervisor 1 stated upon hire an initial and annual competency assessment are performed for testing personnel. General Supervisor 1 confirmed the laboratory did not include a semi-annual assessment during first year of hire in their policy. II. Based on record review and interview with personnel, the laboratory failed to follow their written competency assessment policy for one (1) of two (2) testing personnel. Findings: 1. Review of the laboratory's "Laboratory Personnel Competency" policy revealed "Each new employee will be assessed initially and then annually on all procedures for which they will be responsible." 2. Review of the laboratory's CMS 209 (Laboratory Personnel Report) form revealed General Supervisor 1 and General Supervisor 2 also serve as the laboratory's testing personnel. 3. In interview on February 6, 2020, 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 -- General Supervisor 1 stated General Supervisor 2 serves as the back-up testing personnel if she is off. 4. Review of personnel records for General Supervisor 2 revealed the laboratory did not have competency assessments for testing personnel duties for 2018 and 2019. 5. In further interview on February 6, 2020 at 2:10 pm, General Supervisor 1 stated the laboratory did not have documentation of competency assessments for General Supervisor 2 since 2017. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on February 28, 2018 at Fertility Institute of New Orleans - CLIA ID # 19D1064020. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure competency assessments were performed by appropriate personnel. Refer to D6046. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 record review and interview with personnel, the Technical Consultant failed to assess personnel competency for all employees. Findings: 1. Review of Personnel Report (CMS-209) provided to surveyors revealed Personnel 2 to be listed as Technical Consultant. 2. Review of annual competency for testing personnel revealed that Personnel 3, who is listed as a Testing Personnel on the CMS-209, performed the annual competency for Personnel 2. Further review revealed an individual not listed on teh CMS-209 for this laboratory performed the competency assessment for Personnel 3. 3. In interview on February 28, 2018, Personnel 2 confirmed that Personnel 3 performed her competency assessment but was not listed as a Technical Consultant on the Personnel Report. Personnel 2 also stated that the individual that performed Personnel 3's competency was the laboratory supervisor at the other Fertility Institute location, but was not listed on the Personnel Report for this laboratory. -- 2 of 2 --