Fertility Institute Of New Orleans

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on August 22, 2024 at Fertility Institute of New Orleans CLIA # 19D0459459. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and laboratory policies as well as interview with personnel, the laboratory failed to ensure the Testing Personnel and Laboratory Director signed the attestation statement for one (1) of six (6) proficiency testing (PT) events reviewed. Findings: 1. Review of proficiency testing records from 2023 and 2024 revealed the Laboratory Director and Testing Personnel did not sign the attestation statement for American Proficiency Institute (API) 2023 Chemistry - Core - 1st Event. 2. Review of the laboratory's "Proficiency Testing" policy under section "Documentation" revealed "The individual testing the PT specimens and the laboratory director or designee will sign the attestation statement that the PT specimens are tested under the same conditions as patient specimens." 3. In interview on August 22, 2024 at 10:44 a.m., the Technical Supervisor stated the Laboratory Director and Testing Personnel sign the attestation form generated once the results are input and transmitted to API, but the results were not transmitted and an attestation form was not generated. He confirmed the attestation statement for the event identified above was not signed by the Laboratory Director and Testing Personnel. 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 -- 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 observation, review of manufacturers' storage requirements and the laboratory's temperature records, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for laboratory supplies and reagents for two (2) of two (2) rooms where supplies were stored. Findings: 1. Observation by the surveyor during the laboratory tour on August 22, 2024 at 9:13 a.m. revealed supplies stored in the laboratory and phlebotomy room to include, but not limited to, the following: a) Laboratory - BD Vacutainer C&S Preservative Urine Tube - Manufacturer's storage requirements 4 - 25 degrees Celsius - Copan Transystem sterile transport swab - Manufacturer's storage requirements 5 - 25 degrees Celsius - LeucoScreen Plus - Manufacturer's storage requirements 2 - 25 degrees Celsius - VitalScreen - Manufacturer's storage requirements 2 - 25 degrees Celsius b) Phlebotomy room - BD Vacutainer ACD Solution A Blood Collection Tubes - Manufacturer's storage requirements 4 - 25 degrees Celsius - BD Vacutainer K2EDTA - Manufacturer's storage requirements 4 - 25 degrees Celsius - BD Vacutainer SST Blood Collection Tubes - Manufacturer's storage requirements 4 - 25 degrees Celsius 2. Review of the laboratory's temperature logs from July 2024 revealed the laboratory defined the acceptable room temperature limits for the rooms identified above as 68.0 - 78.8 degrees Fahrenheit (20 - 26 degrees Celsius) which exceeded the manufacturers' upper temperature limits. 3. In interview on August 22, 2024 at 9:20 a.m., the Technical Supervisor confirmed the laboratory's acceptable temperature limits exceeded the manufacturers' requirements as identified above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that 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 testing samples are tested as required. Refer to D2009. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 -- 2 of 4 -- The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation by surveyors, record review, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D2009. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. 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 review of the laboratory's CMS-209 (Laboratory Personnel Report) form, laboratory policies, personnel records, and interview with personnel, the Laboratory Director failed to ensure two (2) of two (2) Testing Personnel had documentation of training prior to patient testing. Findings: 1. Review of the laboratory's CMS-209 revealed the following testing personnel: a) Personnel 2 b) Personnel 3 c) Personnel 4 d) Personnel 5 2. In interview on August 22, 2024 at 10:16 a.m., the Technical Supervisor stated Personnel 4 and Personnel 5 were trained at a sister location in 2023. He further stated they began working at this location in March 2024. 3. Review of personnel records for Personnel 4 and Personnel 5 revealed 2023 training documents with three of the laboratory's locations included at the top of the document but did not indicate which location training occurred. 4. Further review of personnel records for Personnel 4 and Personnel 5 revealed the laboratory did not have documentation of training at this location in 2024. 5. In interview on August 22, 2024 at 10:20 a.m., the Technical Supervisor confirmed the laboratory did not have documentation of training at this laboratory location. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the -- 3 of 4 -- laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisor failed to provide technical and scientific oversight for the laboratory. Refer to D5413. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) form and personnel records as well as interview with personnel, the General Supervisor failed to evaluate the competency of one (1) of one (1) testing personnel annually in 2023. Findings: 1. Review of the laboratory's CMS-209 form revealed the Laboratory Director also served as a General Supervisor. 2. Further review of the CMS-209 revealed the following Testing Personnel: a) Personnel 2 - also served as Technical Supervisor, General Supervisor, and Technical Consultant b) Personnel 3 c) Personnel 4 d) Personnel 5 3. Review of personnel records for Personnel 2 revealed he did not have an annual competency performed in 2023. 4. In interview on August 22, 2024 at 12:05 p.m., the Technical Supervisor confirmed he did not have an annual competency performed for his role as Testing Personnel in 2023. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on February 23, 2023 at Fertility Institute of New Orleans CLIA # 19D0459459. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were 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 review of the laboratory's CMS-209 (Laboratory Personnel Report) form, personnel records, proficiency testing (PT) records, policies, and interview with personnel, the laboratory failed to ensure that proficiency testing for Hematology and Chemistry testing were performed by personnel who routinely perform laboratory testing for three (3) of six (6) events reviewed. Findings: 1. Review of the laboratory's CMS-209 form and personnel records revealed the following: a) The Technical Consultant does not serve as testing personnel b) No record of Personnel 5 serving as testing personnel at the laboratory 2. Review of the laboratory's "Proficiency Testing" policy revealed "The individual testing the PT specimens and the laboratory director or designee will sign the attestation statement that the PT specimens are tested under the same conditions as patient specimens." 3. Review of the laboratory's American Proficiency Institute (API) proficiency testing results revealed personnel not designated as testing personnel performed proficiency testing for the following three (3) events: a) 2021 Hematology/Coagulation 3rd Event: Technical Consultant (the laboratory did not document the specific samples tested) b) 2022 Chemistry-Core 1st Event: Technical Consultant and Personnel 5 (the laboratory did not document 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 10 -- specific samples tested) c) 2022 Chemistry-Core 2nd Event: Technical Consultant and Personnel 5 (the laboratory did not document the specific samples tested) 4. In interview on February 23, 2023 at 10:06 am the Technical Consultant stated he does not serve as testing personnel at the laboratory. The Technical Consultant further stated at 11:51 am that Personnel 5 never served as testing personnel at the laboratory. The Technical Consultant confirmed the laboratory had documentation of non-testing personnel performing proficiency testing. 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 review of the laboratory's policies, proficiency testing (PT) records, and interview with personnel, the laboratory failed to document the sample sets tested by each testing personnel for three (3) of six (6) testing events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed "Each step of handling, preparation, processing, and examination of the PT specimens is documented." 2. Review of the laboratory's American Proficiency Institute (API) records for 2021 and 2022 revealed the testing personnel did not document the specific sample set(s) tested for the following events: a) 2021 Hematology /Coagulation 3rd Event: three (3) personnel tested samples on November 18, 2021 b) 2022 Chemistry-Core 1st Event: four (4) personnel tested samples on February 1, 2022 c) 2022 Chemistry-Core 2nd Event: three (3) personnel tested samples on June 6, 2022 3. In interview on February 23, 2023 at 11:51 am, the Technical Consultant confirmed the laboratory did not document the specific proficiency testing samples tested by personnel. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to have the policies and procedures for testing utilizing the Cobas e411 approved and signed by the current Laboratory Director. Findings: 1. Review of the laboratory's policies for the Cobas e411 analyzer revealed the policies did not include the Laboratory Director's approval/signature for Estradiol (E2), Follicular Stimulating Hormone (FSH), Luteinizing Hormone (LH), Human -- 2 of 10 -- Chorionic Gonadotropin plus Beta (BHCG), Progesterone, Prolactin (PRL), and Thyroid Stimulating Hormone (TSH). 2. In interview on February 23, 2023 at 12:24 PM, the Technical Consultant confirmed that the laboratory director did not approve or sign the policies. 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. This STANDARD is not met as evidenced by: Based on observation, review of test menu and validation records, as well as interview with personnel, the laboratory failed to document complete performance specification verifications for the Cobas e411 Analyzer. Findings: 1. Observation by surveyors on February 23, 2023 at 10:12 a.m. revealed the laboratory utilized the Cobas e411 analyzer. 2. Review of the laboratory test menu revealed the laboratory utilized the Cobas e411 for Estradiol (E2), Follicular Stimulating Hormone (FSH), Luteinizing Hormone (LH), Human Chorionic Gonadotropin plus Beta (BHCG), Progesterone, Prolactin (PRL), and Thyroid Stimulating Hormone (TSH) testing. 3. Review of the "Chemistry Analyzer Validation Summary" revealed the laboratory did not include the following: a) Precision studies with documentation and explanation of exclusion of data points and a summary that matched performance of studies. b) Reportable range with raw data to support verification of lowest achievable value for Estradiol. 4. Further review of the "Chemistry Analyzer Validation Summary" revealed a description of accuracy and between-run precision studies that utilized twenty-four points and between-day precision studies that used "Three levels with different analyte concentrations over at least a 30 day period." This description differed from another document labeled "Precision Study" which stated "Precision was determined by 24 to 30 measurements of different analyte concentrations in control media (Level 1 Level 2, and Level 3),on different days, by three technicians..." The laboratory's "Precision Study" chart included twenty-nine (29) points for level 1, twenty-six (26) points for level 2, and twenty-four (24) points for level 3, except for the analyte LH which had twenty-three (23) points. 5. Further review of the "Chemistry Analyzer Validation Summary" section "Analytical Measuring Range" revealed the laboratory's minimum reportable value for Estradiol was 5.00 pg/mL which is the lowest detectable value according to the manufacturer; however, review of the raw data revealed the laboratory detected 119 pg/mL as the minimum value for Estradiol. 6. In interview February 23, 2023 at 11:51 AM, the Technical Consultant stated he was unable explain why some data was excluded and why some data did not match the studies. He also confirmed the lowest value achieved by the laboratory did not correlate with the lowest value achieved by the manufacturer. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory -- 3 of 10 -- 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 observation by surveyors, review of the laboratory's maintenance logs, and interview with personnel, the laboratory failed to perform weekly maintenance as required by the manufacturer for two (2) of fifty two (52) weeks in 2022 for Chemistry testing. Findings: 1. Observation by surveyors during the laboratory tour on February 23, 2023 at 10:14 am revealed the laboratory utilizes the Cobas e 411 analyzer for Chemistry testing. 2. Review of the laboratory "cobas e 411 analyzer Maintenance Log" revealed the following weekly tasks: a) clean incubator and aspiration station b) clean sipper probe 3. Further review of the Cobas maintenance logs revealed weekly maintenance was not documented for the following: a) February 2022: missing the week of February 7, 2022 b) November 2022: missing the week of November 28, 2022 4. In interview on February 23, 2023 at 3:12 pm, the Technical Consultant confirmed the laboratory did not have documentation of maintenance for the identified weeks. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's policy and procedure manual, test menu, quality control records, and quality control package inserts; as well as interview with laboratory personnel, the laboratory failed to establish their own mean and ranges for chemistry Quality Control (QC) material as required by the manufacturer for twenty-two (22) of twenty-three (23) months. Findings: 1. Observation by surveyors during the tour of the laboratory on February 23, 2023 at 10:12 AM revealed the laboratory maintained a Cobas e411 analyzer. 2. Review of the test menu revealed the laboratory used the Cobas e411 for testing of Estradiol (E2), Follicular Stimulating Hormone (FSH), Luteinizing Hormone (LH), Human Chorionic Gonadotropin plus Beta (BHCG), Progesterone, Prolactin (PRL), and Thyroid Stimulating Hormone (TSH). 3. Review of the laboratory policy "Quality Controls" revealed the laboratory used "Biorad Lyphochek Assayed Immunoassay Levels 1, 2, and 3" for chemistry quality control. 4. Further review of the "Quality Controls" policy revealed "When a new lot number of control is put into use, the new control is run between 15 and 30 days along with the current lot number of control to verify that the values are falling within then (sic) stated values of the package insert for the -- 4 of 10 -- appropriate control. A new mean and standard deviation is calculated. These values are then used to replace the stated values in the package insert for all chemistry test except AMH. AMH control range from the manufacturer is used as laboratory range because of the cost of Testing (Reagent, Calibrator, and Control) and infrequency of testing." 5. Review of the "Bio-Rad Lyphochek Immunoassay Plus Control Levels 1, 2, and 3" package insert section "Assignment of Values" revealed "It is recommended that each laboratory establish its own acceptable ranges and use those provided only as a guide." 6. Review of the laboratory's quality control records revealed that the laboratory used BioRad's lot specific mean and acceptable range and did not have documentation of establishing its own lot specific mean and range until February 2, 2023. a) Bio-Rad Lyphochek Immunoassay Plus Control, Lot # 40390, Expiration 12 /31/2022, Laboratory put in use 3/20/2021 b) Bio-Rad Lyphochek Immunoassay Plus Control, Lot #40410, Expiration 9/30/2024, Laboratory put in use 5/2/2022 7. In interview on February 23, 2023 at 1:20 PM, the Technical Consultant confirmed the laboratory did not have raw data demonstrating the laboratory's established their own quality control mean and acceptable range prior to February 2023. D5783

Summary Statement of Deficiencies D0000 A Certification survey was performed on February 11, 2021 at Fertility Institute of New Orleans, CLIA ID # 19D0459459. 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: Based on direct observation by surveyor, review of personnel records, CMS-209 form, and interview with personnel, the laboratory failed to evaluate competency in 2019 and 2020 for one (1) of three (3) Testing Personnel reviewed per laboratory policy. Findings: 1. Review of the laboratory's "Laboratory Personnel Competency" policy revealed "Each new employee will be assessed initially after training, at six months, 12 months, and then annually on all procedures for which they will be responsible." 2. Direct observation by surveyor on February 11, 2021 at 9:08 am, revealed the Technical Consultant performed laboratory testing. The Technical Consultant served as the testing personnel on the day of the survey. 3. Review of the laboratory's previous CMS-209 form (Laboratory Personnel Report) dated May 14, 2018 revealed the current Technical Consultant was listed as Testing Personnel. 4. Review of personnel records for the Technical Consultant revealed the laboratory did not have documentation of annual competency assessment for his Testing Personnel duties in 2019 and 2020 for endocrinology, urinalysis, and semen analysis testing. 5. In interview on February 11, 2021 at 9:49 am, the Technical Consultant stated he rarely comes to this facility; he was testing due to a loss of employees. The Technical 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 -- Consultant confirmed the laboratory did not perform competency for his duties as Testing Personnel for 2019 and 2020. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's policies, quality control (QC) records, and interview with personnel, the laboratory failed to verify acceptability of new lot numbers and/or shipments of quality control materials utilized for semen analysis. Findings: 1. Observation by surveyor during laboratory tour on February 11, 2021 at 9:08 am revealed the laboratory utilizes Accu-beads as the QC material for semen analysis. 2. Review of the laboratory's "Establishing QC Ranges for Sperm Counting effective 2/9/2020" policy revealed "The Laboratory must verify that the test performance is similar to the control values provided with the external control. The Laboratory must also develop methods of Internal Quality Control to monitor precision for test procedures to determine when testing procedures are outside control limits and not producing acceptable results." 3. Further review of the "Establishing QC Ranges for Sperm Counting" policy revealed a written procedure for establishing bead lot mean and ranges that included a comparison between the laboratory's different locations. Step "n" included the following statement: "Perform the above testing when acquiring a new lot of Accubeads and/or Cell Vision Slides. It is advisable to begin this testing at least a month before a new bead lot or slide lot is put into use." 4. Review of the laboratory's QC records for the Accu-beads revealed the laboratory did not have documentation of performance of the identified QC verification studies for the lot in current use. 5. In interview on February 11, 2021 at 12:06 pm, the Technical Consultant stated the laboratory does not perform the identified procedure. The Technical Consultant further stated he was unaware of the identified procedure. The Technical Consultant confirmed the laboratory did not verify the Accu-bead QC performance of new lots/shipments prior to use. 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 -- 2 of 3 -- 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 observation by surveyor, record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D5209. 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 record review and interview with personnel, the Laboratory Director failed to ensure that a quality control program was maintained to assure the quality of laboratory testing. Refer to D5469. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 observation by surveyor, record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D5209. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on May 17, 2018 at Fertility Institute of New Orleans-CLIA ID # 19D0459459. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to establish complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not establish a complete policy for the following: a) Control procedure for Semen Analysis (Accubeads) to include number and frequency 2. In interview on May 17, 2018 at 12:00 pm, Personnel 2 stated for semen analysis the laboratory performs quality control in duplicate prior to patient testing. Personnel 2 confirmed the laboratory's policy did not include the number and frequency of control material utilized for semen analysis. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have the policy and procedure manual, approved, signed, and dated by the current Laboratory Director. Finding: 1. In interview on May 17, 2018 at 9:05 am, Personnel 2 stated the laboratory had a new Laboratory Director as of April 2018. 2. Review of the laboratory's Policy and Procedure Manual revealed the manual was not approved and signed by the current Laboratory Director. 3. In interview on May 17, 2018 at 10:08 am, Personnel 2 stated the new Laboratory Director did not sign the policy and procedure manual. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to establish and verify performance specification for accuracy, precision, reportable and reference ranges, analytical sensitivity, and specificity for microscopic semen analysis testing. Findings: 1. Observation by surveyor during laboratory tour on May 17, 2018 revealed the laboratory performs microscopic semen analysis. 2. In interview on May 17, 2018 at 9:05 am, Personnel 2 stated the laboratory added microscopic semen and post vasectomy analysis since their previous inspection. 3. Review of laboratory records revealed the laboratory did not have documentation of performance specification studies for microscopic semen analysis. 4. In interview on May 17, 2018 at 10:25 am, Personnel 2 stated the laboratory began performing microscopic quantitative semen analysis including post vasectomy semen analysis on November 1, 2017. Personnel 2 further stated no performance specification studies had been performed for semen analysis testing. Personnel 2 stated she was unaware it was needed. 5. Review of the laboratory's Task 1 and 3 form revealed the laboratory performs three hundred (300) microscopic semen and one hundred (100)microscopic post vasectomy analysis annually. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform microscope preventative maintenance per laboratory policy. Findings: 1. Review of the laboratory's microscope maintenance records revealed "semi-annual PM of microscope." 2. Further review of the laboratory's 2017 microscope maintenance records revealed the laboratory performed semi-annual preventative maintenance on the following date: April 10,2017 3. In interview on May 17, 2018 at 12:21 pm, Personnel 2 stated preventative maintenance for the microscope is performed semi- annually by an outside vendor. Personnel 2 confirmed preventative maintenance was not performed semi-annually in 2017. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to establish pertinent performance characteristics for microscopic semen analysis. Refer to D5423. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must 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 record review and interview with personnel, the Laboratory Director failed to ensure documentation of maintenance procedures as required. Refer to D5433. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Findings: 1. The laboratory failed to establish complete policies and procedures. Refer to D5401. 2. The laboratory failed to have the policy and procedure manual, approved, signed, and dated by the current Laboratory Director. Refer to D5407. -- 3 of 3 --